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Food and Drug Administration (FDA)

75 Fed. Reg. 66769 (October 29, 2010) (notice). The FDA is extending the comment period for a notice of availability of a draft compliance policy guide related to animal feed or feed ingredients that are adulterated due to the presence of Salmonella. View this document.

75 Fed. Reg. 65491 (October 25, 2010) (notice). The FDA is announcing that a proposed collection of information related to the “Guide To Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables” has been submitted for review and clearance. View this document.

75 Fed. Reg. 63095 (October 14, 2010) (final rule) (to be codified at 21 C.F.R. Part 529). The FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for use of progesterone for synchronization of estrus in lactating dairy cows. View this document.

75 Fed. Reg. 62545 (October 12, 2010) (notice). The FDA is announcing the filing of a petition proposing that the food additive regulations be amended to provide for the safe use of virginiamycin as an antimicrobial processing aid in fuel-ethanol fermentations with respect to its consequent presence in by-product distiller grains used as an animal feed or feed ingredient. View this document.

75 Fed. Reg. 61501 (October 5, 2010) (notice). The FDA is announcing its intention to accept and consider a single source application to award a cooperative agreement to the World Health Organization Advisory Group on Integrated Surveillance of Antimicrobial Resistance and in support of the WHO Global Foodborne Infections Network and to provide guidance to the WHO on a framework for the development of an international network to promote and enhance collaboration on harmonization and data sharing among countries with Antimicrobial Resistance surveillance programs. View this document.

75 Fed. Reg. 61503 (October 5, 2010) (notice). The FDA announces its intention to accept and consider a single source application for awarding a cooperative agreement to the World Health Organization, Department of Food Safety and Zoonoses, to develop a plan for a global integrated food safety information system or platform in partnership with the WHO Secretariat and the Member States. View this document.

75 Fed. Reg. 59266 (September 27, 2010) (notice). The FDA is announcing that the following proposed collection of information has been submitted to OMB for review and clearance: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. View this document.

75 Fed. Reg. 59268 (September 27, 2010) (notice). The FDA is announcing the availability of a draft guidance entitled “Guidance for Industry: Acidified Foods.” View this document.

75 Fed. Reg. 56112 (September 15, 2010) (notice). The FDA is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2010 to the National Center for Food Protection and Defense. View this document.

75 Fed. Reg. 55676 (September 14, 2010) (final rule) (to be codified at 21 C.F.R. Parts 510, 520 and 558). The Food and Drug Administration is amending the animal drug regulations by removing those portions that reflect approval of four new animal drug applications. View this document.

75 Fed. Reg. 55793 (September 14, 2010) (notice). The Food and Drug Administration is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2010 to the World Health Organization. View this document.

75 Fed. Reg. 55810 (September 14, 2010) (notice). The Food and Drug Administration is withdrawing approval of four new animal drug applications. View this document.

75 Fed. Reg. 54492 (September 8, 2010) (final rule) (to be codified at 21 C.F.R. Part 520). The FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for use of an increased strength of tiamulin concentrate solution in the drinking water of swine for the treatment of certain bacterial respiratory and enteric diseases. View this document.

75 Fed. Reg. 54019 (September 3, 2010) (final rule) (to be codified at 21 C.F.R. Part 558). The FDA is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications providing for administering a Type C medicated feed containing ractopamine hydrochloride as a top dress on Type C medicated feeds containing monensin, USP, or monensin, USP, and tylosin phosphate to cattle fed in confinement for slaughter. View this document.

75 Fed. Reg. 52601 (August 26, 2010) (notice). The Food and Drug Administration is announcing a public hearing regarding the labeling of food derived from AquAdvantage Salmon, a genetically engineered Atlantic salmon. View this document.

75 Fed. Reg. 51077 (August 18, 2010) (notice). The FDA is announcing an opportunity for public comment on the proposed collection of certain information on reporting requirements in implementing the lists of U.S. firms/processors exporting shell eggs, dairy products, game meat, game meat products, animal casings, gelatin, and collagen to the European Community. View this document.

75 Fed. Reg. 48973 (August 12, 2010) (notice). The Food and Drug Administration is announcing the availability of a draft guidance entitled “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” View this document.

75 Fed. Reg. 48692 (August 11, 2010) (notice). This notice solicits comments on the information collection provisions in the guidance document entitled “Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables.” View this document.

75 Fed. Reg. 48350 (August 10, 2010) (notice). Food and Drug Administration is announcing that a proposed collection of information regarding infant formula requirements has been submitted for review and clearance. View this document.

75 Fed. Reg. 48353 (August 10, 2010) (notice). The Food and Drug Administration is announcing that the U.S. Pharmacopeial Convention has filed a petition proposing that the food additive regulations that incorporate by reference food-grade specifications from prior editions of the Food Chemicals Codex be amended to incorporate by reference food-grade specifications from the FCC, 7th Edition. View this document.

75 Fed. Reg.45130 (August 2, 2010) (notice). The FDA is announcing the availability of a draft guidance for FDA staff entitled "Compliance Policy Guide Sec. 690.800 Salmonella in Animal Feed." View this document.

75 Fed. Reg.44973 (July 30, 2010) (notice). The Food and Drug Administration is announcing the availability of a report entitled "A New Approach to Targeting Inspection Resources and Identifying Patterns of Adulteration: The Reportable Food Registry." View this document.

75 Fed. Reg.43990 (July 27, 2010) (notice). The FDA is announcing an opportunity for public comment on the proposed collection of certain information for the proposed Pet Event Tracking Network cooperative Federal and State initiative. View this document.

75 Fed. Reg.43182 (July 23, 2010) (notice). FDA is issuing this notice to assist restaurants and similar retail food establishments and vending machine operators that are not subject to the menu labeling requirements of section 4205 of the Affordable Care Act, but choose to register to become subject to them, in voluntarily registering with FDA, pending promulgation of regulations. View this document.

75 Fed. Reg.42446 (July 21, 2010) (notice). The FDA is announcing an opportunity for public comment on the information collection provisions in the guidance document entitled "Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition." View this document.

75 Fed. Reg.42095 (July 20, 2010) (notice). The FDA is announcing an opportunity for public comment on the proposed collection of certain information related to reporting requirements contained in existing FDA regulations governing petitions to request an exemption from 100 percent identity testing of dietary ingredients. View this document.

75 Fed. Reg.41725 (July 19, 2010) (final rule) (to be codified at 21 C.F.R. Part 573). The FDA is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of ammonium formate as an acidifying agent in swine feed. View this document.

75 Fed. Reg.41207 (July 15, 2010) (notice). The FDA is announcing that the following proposed collection of information has been submitted to for review and clearance: Food Labeling Regulations--21 C.F.R. Parts 101, 102, 104, and 105—Extension. View this document.

75 Fed. Reg.40840 (July 14, 2010) (notice). The FDA is announcing an opportunity for public comment on the proposed collection of information regarding current good manufacturing practice for dietary supplements. View this document.

75 Fed. Reg.40839 (July 14, 2010) (notice). The FDA is announcing an opportunity for public comment on the proposed collection of information on recordkeeping requirements for applying hazard analysis and critical control point procedures for safe and sanitary processing for processors of fruit and vegetable juice. View this document.

75 Fed. Reg.39699 (July 12, 2010) (notice). This notice announces the withdrawal, without prejudice to a future filing, of a food additive petition proposing that the food additive regulations be amended to provide for the safe use of ionizing radiation in the production of shelf stable foods. View this document.

75 Fed. Reg.39026 (July 7, 2010) (notice). The FDA is announcing the opening of a docket to solicit comments, data, and other information helpful to the implementation of section 4205 of the Patient Protection and Affordable Care Act of 2010, which requires certain chain restaurants, similar retail food establishments and vending machine operators to disclose nutrient content information. View this document.

75 Fed. Reg. 37450 (June 29, 2010) (notice). The FDA is announcing the availability of a draft guidance entitled "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals." View this document.

75 Fed. Reg. 36558 (June 28, 2010) (advance notice of proposed rulemaking; extension of comment period). The FDA is extending to August 27, 2010, the comment period for the advance notice of proposed rulemaking from March 29, 2010, which requested comments on the need for improvements to the veterinary feed directive regulation. View this document.

75 Fed. Reg. 36097 (June 24, 2010) (notice). The FDA is announcing that the following proposed collection of information has been submitted for review and clearance: Adoption of the FDA Food Code by Local, State, and Tribal Governments—42 U.S.C. 243(a) (OMB Control Number 0910-0448)—Extension. View this document.

75 Fed. Reg. 36091 (June 24, 2010) (notice). The FDA is announcing that the following proposed collection of information has been submitted for review and clearance: Threshold of Regulation for Substances Used in Food-Contact Articles—(OMB Control Number 0910-0298)—Extension. View this document.

75 Fed. Reg. 34746 (June 18, 2010) (notice). The FDA is announcing that a proposed collection of information has been submitted for review and clearance: Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products—Extension. View this document.

75 Fed. Reg. 34744 (June 18, 2010) (notice). The FDA is announcing that a proposed collection of information has been submitted for review and clearance: Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed—Extension. View this document.

75 Fed. Reg. 34745 (June 18, 2010) (notice). This notice solicits comments on a survey on Consumers' Emotional and Cognitive Reactions to Food Recalls. View this document.

75 Fed. Reg. 34361 (June 17, 2010) (final rule) (to be codified at 21 C.F.R. Part 558). The FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for the manufacture of florfenicol Type B medicated swine feeds. View this document.

75 Fed. Reg. 33624 (June 14, 2010) (notice). The FDA is announcing an opportunity for public comment on the proposed collection of certain information on provisions of FDA's regulations for submission of petitions, including food and color additive petitions (including labeling) and generally recognized as safe affirmations. View this document.

75 Fed. Reg. 31800 (June 4, 2010) (notice). The FDA is seeking participants for a voluntary pilot program whereby persons submit to FDA notices of claims that a particular use of a substance in food for animals is exempt from the statutory premarket approval requirements based on the notifier's determination that such use is generally recognized as safe. View this document.

75 Fed. Reg. 30844 (June 2, 2010) (notice). The FDA is announcing the withdrawal, without prejudice to a future filing, of a food additive petition proposing that the food additive regulations be amended to provide for the safe use of ultraviolet radiation for the reduction of pathogens and other microorganisms in aqueous sugar solutions and potable water intended for use in food production. View this document.

75 Fed. Reg. 29775 (May 27, 2010) (notice). This notice announces a public workshop entitled "Food Labeling Workshop" to be held on August 4 and 5, 2010. View this document.

75 Fed. Reg. 29350 (May 25, 2010) (notice). The FDA is announcing the availability of a draft guidance entitled "Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2)." View this document.

75 Fed. Reg. 28622 (May 21, 2010) (notice; request for comments). The FDA is announcing the availability of a report entitled "FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration." View this document.

75 Fed. Reg. 28263 (May 20, 2010) (notice; extension of comment period). The FDA is extending to July 23, 2010, the comment period for a notice published on February 23, 2010, establishing a docket to obtain comments and information about current practices and conditions for the production and packing of fresh produce. View this document.

75 Fed. Reg. 26967 (May 13, 2010) (notice). The FDA is announcing the availability of a guidance entitled "Guidance for Industry: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water Advisory." View this document.

75 Fed. Reg. 26647 (May 12, 2010) (final rule) (to be codified at 21 C.F.R. Part 522). The FDA is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application providing for use of an ivermectin injectable solution in cattle and swine for treatment and control of various internal and external parasites. View this document.

75 Fed. Reg. 26647 (May 12, 2010) (final rule) (to be codified at 21 C.F.R. Part 524). The FDA is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application adding claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a topical solution of ivermectin. View this document.

75 Fed. Reg. 23777 (May 4, 2010) (notice). The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency regarding the manufacture of infant formula, including infant formula labeling, quality control procedures, notification requirements, and recordkeeping. View this document.

75 Fed. Reg. 23773 (May 4, 2010) (notice). The FDA is announcing that a proposed collection of information, "Real Time" Surveys of Consumers' Knowledge, Perceptions, and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls, has been submitted for review and clearance. View this document.

75 Fed. Reg. 22713 (April 30, 2010) (advance notice of proposed rulemaking). The FDA is issuing an advance notice of proposed rulemaking to request data and information on the food transportation industry and its practices, and on the contamination of transported foods and any associated outbreaks. View this document.

75 Fed. Reg. 22602 (April 29, 2010) (notice). The FDA is announcing the establishment of a docket to obtain data and other information that will inform the agency's deliberations about ways to enhance the usefulness to consumers of point-of-purchase nutrition information, such as information on the principal display panel of food products or on shelf tags in retail stores. View this document.

75 Fed. Reg. 22411 (April 28, 2010) (notice). The Food and Drug Administration is announcing that Fonterra (USA) Inc. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of hydrogen peroxide in the manufacture of modified whey by the ultrafiltration method. View this document.

75 Fed. Reg. 21300 (April 23, 2010) (notice). This notice announces the filing of a petition proposing that the food additive regulations be amended to provide for the safe use of erythromycin thiocyanate as an antimicrobial processing aid in fuel-ethanol fermentations with respect to its consequent presence in by-product distiller grains used as an animal feed or feed ingredient. View this document.

75 Fed. Reg. 20917 (April 22, 2010) (final rule) (to be codified at 21 C.F.R. Part 558). This rule amends the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application providing for an increased level of monensin in three-way combination Type C medicated feeds containing ractopamine, melengestrol, and monensin for heifers fed in confinement for slaughter. View this document.

75 Fed. Reg. 21000 (April 22, 2010) (notice). This notice announces the availability of a draft guidance entitled "Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers." View this document.

75 Fed. Reg. 20615 (April 20, 2010) (notice). The Food and Drug Administration is requesting comments and scientific data and information that would assist the agency in its plans to conduct a risk profile for pathogens and filth in spices. View this document.

75 Fed. Reg. 19405 (April 15, 2010) (notice). This notice announces an opportunity for public comment on the proposed collection of information from local, State, and tribal governmental agencies concerning their adoption of, or plans to adopt, all or portions of the FDA Food Code or its equivalent by regulation, law, or ordinance. View this document.

75 Fed. Reg. 18751 (April 13, 2010) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 118). The Food and Drug Administration is amending its regulations to correct the date by which egg producers must register their farm with FDA, reflect a change in the address and telephone number for requesting copies of Form No. 3733, and reflect a change in the address to which producers must send their CD-ROM. View this document.

75 Fed. Reg. 18849 (April 13, 2010) (notice). The Food and Drug Administration is announcing the availability of a guidance entitled "Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation--Small Entity Compliance Guide." View this document.

75 Fed. Reg. 18505 (April 12, 2010) (notice). The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Draft Guidance for Industry on Guidances for the Validation of Analytical Methods Used in Residue Depletion Studies." It is one of a series developed to facilitate the mutual acceptance of residue chemistry data for veterinary drugs used in food-producing animals. View this document.

75 Fed. Reg. 18507 (April 12, 2010) (notice). The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals," VICH GL47. View this document.

75 Fed. Reg. 18504 (April 12, 2010) (notice). The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods," (VICH GL48). View this document.

75 Fed. Reg. 18508 (April 12, 2010) (notice). The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study to Determine the Quantity and Identify the Nature of Residues (MRK)," VICH GL46. View this document.

75 Fed. Reg. 18211 (April 9, 2010) (notice). This notice announces an opportunity for public comment on the proposed collection of information related to provisions of FDA's regulations requiring reporting and recordkeeping for processors and importers of fish and fishery products. View this document.

75 Fed. Reg. 18209 (April 9, 2010) (notice). This notice announces an opportunity for public comment on the proposed collection of information related to requests for exemption from the food additive listing regulation requirements that are submitted under 21 C.F.R. Part 170. View this document.

75 Fed. Reg. 17923 (April 8, 2010) (notice). The Food and Drug Administration is announcing that a collection of information entitled "Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water" has been approved. View this document.

75 Fed. Reg. 17928 (April 8, 2010) (notice). This notice announces the filing of a petition proposing that the food additive regulations for hydroxypropyl cellulose be amended by lowering the minimum viscosity and to permit its use as a binder in dietary supplements. View this document.

75 Fed. Reg. 17939 (April 8, 2010) (notice). This notice announces the withdrawal, without prejudice to a future filing, of the remaining portion of a color additive petition proposing an amendment to provide for the safe use of composite pigments prepared from synthetic iron oxide, mica, and titanium dioxide to color food. View this document.

75 Fed. Reg. 17145 (April 5, 2010) (notice; request for comment). The Food and Drug Administration is announcing the availability of five documents related to FDA's continuing assessment of Bisphenol A and soliciting public comments on the four documents prepared by FDA's Center for Food Safety and Applied Nutrition. View this document.

75 Fed. Reg. 16817 (April 2, 2010) (notice). The Food and Drug Administration is announcing a public meeting entitled "2010 Scientific Meeting of the National Antimicrobial Resistance Monitoring System." View this document.

75 Fed. Reg. 16363 (April 1, 2010) (proposed rule). The Food and Drug Administration is reopening until June 1, 2010, the comment period for the proposed rule amending the quality standard for bottled water. View this document.

75 Fed. Reg. 15714 (March 30, 2010) (notice). The Food and Drug Administration is announcing a public meeting for individuals and groups interested in nominating voting and nonvoting consumer representatives to FDA advisory committees and panels. View this document.

75 Fed. Reg. 15342 (March 29, 2010) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 14). This rule amends the regulations on public hearings before public advisory committees to reflect an internal change with respect to the staff that handles the nomination and selection process for nonvoting members representing consumer interests for standing technical advisory committees. View this document.

75 Fed. Reg. 15387 (March 29, 2010) (advance notice of proposed rulemaking). The Food and Drug Administration is announcing an advance notice of proposed rulemaking to solicit comments from the public regarding potential changes to its current regulation relating to veterinary feed directive drugs. View this document.

75 Fed. Reg. 14607 (March 26, 2010) (notice). The Food and Drug Administration is announcing the availability of a guidance for industry entitled "Bottled Water: Total Coliform and E. coli—Small Entity Compliance Guide" for a final rule published on May 29, 2009. View this document.

75 Fed. Reg. 14445 (March 25, 2010) (notice). The Food and Drug Administration is announcing the availability of a guidance document entitled "Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007." View this document.

75 Fed. Reg. 13555 (March 22, 2010) (notice; withdrawal). The Food and Drug Administration is announcing the withdrawal of Compliance Policy Guide Sec. 540.375 Canned Salmon –Adulteration Involving Decomposition (CPG 7108.10) (CPG Sec. 540.375). View this document.

75 Fed. Reg. 13556 (March 22, 2010) (notice; request for comments). The Food and Drug Administration is establishing a public docket to provide an opportunity for interested parties to share information, research, and ideas on how use of dissolvable tobacco products may impact public health, including such use among children. View this document.

75 Fed. Reg. 13225 (March 19, 2010) (final rule) (to be codified at 21 C.F.R. Part 522). The Food and Drug Administration is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application providing for the use of flunixin meglumine injectable solution in swine. View this document.

75 Fed. Reg. 13225 (March 19, 2010) (final rule) (to be codified at 21 C.F.R. Part 1140). The Food and Drug Administration is reissuing a final rule restricting the sale, distribution, and use of cigarettes and smokeless tobacco. View this document.

75 Fed. Reg. 13241 (March 19, 2010) (advance notice of proposed rulemaking). The Food and Drug Administration is issuing this advance notice of proposed rulemaking to obtain information related to the regulation of outdoor advertising of cigarettes and smokeless tobacco. View this document.

75 Fed. Reg. 12981 (March 18, 2010) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for revised labeling for a 25 gram per pound concentration of tetracycline hydrochloride soluble powder used to make medicated drinking water for calves, swine, chickens, and turkeys. View this document.

75 Fed. Reg. 12759 (March 17, 2010) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to the Office of Management and Budget for review and clearance: Abbreviated New Animal Drug Applications—FD&C Act/Section 512(n)(1). View this document.

75 Fed. Reg. 12549 (March 16, 2010) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of information related to FDA's regulations requiring that the agency receive prior notice before food is imported or offered for import into the United States. View this document.

75 Fed. Reg. 12547 (March 16, 2010) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of information related to the agency's regulations that require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. View this document.

75 Fed. Reg. 11893 (March 12, 2010) (notice). The Food and Drug Administration is soliciting comments from interested persons on ways in which FDA can increase transparency between FDA and regulated industry. View this document.

75 Fed. Reg. 11451 (March 11, 2010) (final rule) (to be codified at 21 C.F.R. Part 558). The FDA is amending the animal drug regulations to reflect approval of three abbreviated new animal drug applications that provide for use of single-ingredient Type A medicated articles containing zilpaterol, melengestrol, monensin, and tylosin to make two-way, three-way, and four-way combination drug Type B and Type C medicated feeds for heifers fed in confinement for slaughter. View this document.

75 Fed. Reg. 10413 (March 8, 2010) (direct final rule; confirmation of effective date). The FDA is confirming the effective date of March 8, 2010, for the final rule that provides that new animal drug applications shall be submitted in the described form, as appropriate for the particular submission. View this document.

75 Fed. Reg. 9605 (March 3, 2010) (notice). This notice announces that the following proposed collection of information has been submitted to OMB for review and clearance: Manufactured Food Regulatory Program Standards—Extension. View this document.

75 Fed. Reg. 9333 (March 2, 2010) (final rule) (to be codified at 21 C.F.R. Part 522). This rule amends the animal drug regulations to reflect approval of a supplemental new animal drug application providing a dose range for use of an injectable solution of tilmicosin phosphate for treatment of respiratory disease in cattle and additional pathogens for which this therapy is effective. View this document.

75 Fed. Reg. 9334 (March 2, 2010) (final rule) (to be codified at 21 C.F.R. Part 558). This rule amends the animal drug regulations to reflect approval of a supplemental new animal drug application providing for use of a higher concentration chlortetracycline Type A medicated article for the manufacture of medicated feeds for livestock and poultry. View this document.

75 Fed. Reg. 9225 (March 1, 2010) (notice). This notice announces an opportunity for public comment on the proposed collection of information on pretesting of tobacco communications. View this document.

75 Fed. Reg. 9232 (March 1, 2010) (notice). The Food and Drug Administration is announcing a public workshop entitled Measuring Progress on Food Safety: Current Status and Future Directions. View this document.

75 Fed. Reg. 8959 (February 26, 2010) (notice). This notice announces an opportunity for public comment on the proposed collection of information concerning substances prohibited from use in animal food or feed and animal proteins prohibited in ruminant feed. View this document.

75 Fed. Reg. 8960 (February 26, 2010) (notice). This notice announces that the following proposed collection of information has been submitted to OMB for review and clearance: Third Party Disclosure and Recordkeeping Requirements for Reportable Food—21 U.S.C. 350f –Extension. View this document.

75 Fed. Reg. 8086 (February 23, 2010) (notice; request for comments). The Food and Drug Administration is announcing the opening of a docket to obtain information about current practices and conditions for the production and packing of fresh produce. View this document.

75 Fed. Reg. 7555 (February 22, 2010) (final rule) (to be codified at 21 C.F.R. Part 558). This rule amends the animal drug regulations to reflect approval of an original abbreviated new animal drug application providing for use of single-ingredient Type A medicated articles containing bacitracin zinc and nicarbazin to make two-way combination drug Type C medicated feeds for broiler chickens. View this document.

75 Fed. Reg. 7604 (February 22, 2010) (notice). This notice announces an opportunity for public comment on the proposed collection of information on the Experimental Study of Graphic Cigarette Warning Labels. View this document.

75 Fed. Reg. 7490 (February 19, 2010) (notice). The Food and Drug Administration is announcing the reorganization of the Office of the Commissioner. View this document.

75 Fed. Reg. 7272 (February 18, 2010) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to OMB for review and clearance: Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008--Extension. View this document.

75 Fed. Reg. 7274 (February 18, 2010) (notice). This notice solicits comments on the information collection provisions of FDA's consultation procedures for foods derived from new plant varieties, including the information collection provisions in the guidance entitled "Consultation Procedures: Foods Derived From New Plant Varieties," and in Form FDA 3665 entitled "Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation)." View this document.

75 Fed. Reg. 7269 (February 18, 2010) (notice). This notice solicits comments on the proposed extension of an existing collection of information pertaining to registration and product listing for owners and operators of domestic tobacco product establishments and to listing of ingredients in tobacco products under the Family Smoking Prevention and Tobacco Control Act. View this document.

75 Fed. Reg. 7279 (February 18, 2010) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to OMB for review and clearance: Tobacco Product Standard on Flavored Cigarettes—Extension. View this document.

75 Fed. Reg. 5887 (February 5, 2010) (final rule; confirmation of effective date). The Food and Drug Administration is confirming the effective date of December 8, 2009, for the final rule that amended the color additive regulations to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive in the feed of salmonid fish. View this document.

75 Fed. Reg. 5887 (February 5, 2010) (final rule; confirmation of effective date). The Food and Drug Administration is confirming the effective date of December 17, 2009, for the final rule that amended the color additive regulations to provide for the safe use of paracoccus pigment as a color additive in the feed of salmonid fish. View this document.

75 Fed. Reg. 5887 (February 5, 2010) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of an original new animal drug application providing for use of single-ingredient Type A medicated articles containing ractopamine hydrochloride and monensin to formulate two-way combination Type C medicated feeds for finishing hen and tom turkeys. View this document.

75 Fed. Reg. 4079 (January 26, 2010) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to OMB for review and clearance: Food Labeling; Notification Procedures for Statements on Dietary Supplements--21 CFR 101.93. View this document.

75 Fed. Reg. 4077 (January 26, 2010) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to OMB for review and clearance: Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle--21 CFR 189.5(c) and 700.27(c). View this document.

75 Fed. Reg. 4087 (January 26, 2010) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to OMB for review and clearance: Interstate Shellfish Dealers Certificate. View this document.

75 Fed. Reg. 3738 (January 22, 2010) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to OMB for review and clearance: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile (OMB Control Number 0910-0509)—Extension. View this document.

75 Fed. Reg. 3735 (January 22, 2010) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to OMB for review and clearance: Medicated Feed Mill License Application--(OMB Control No. 0910-0337)—Extension. View this document.

75 Fed. Reg. 2864 (January 19, 2010) (notice). The Food and Drug Administration is announcing that the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2009. View this document.

75 Fed. Reg. 2865 (January 19, 2010) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to OMB for review and clearance: Records and Reports Concerning Experience with Approved New Animal Drugs; Adverse Event Reports on Forms FDA 1932, 1932a, and 2301—Extension. View this document.

75 Fed. Reg. 2867 (January 19, 2010) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to OMB for review and clearance: Food Additive Petitions—Extension. View this document.

75 Fed. Reg. 2879 (January 19, 2010) (notice). The Food and Drug Administration is establishing a public docket to provide an opportunity for interested parties to share information, research, and ideas on tobacco product marketing descriptors that may be considered similar to the prohibited terms "light," "mild," and "low." View this document.

75 Fed. Reg. 2145 (January 14, 2010) (notice; correction). This document corrects an error in a draft guidance entitled "Tobacco Health Document Submission." View this document.

75 Fed. Reg. 1274 (January 11, 2010) (final rule) (to be codified at 21 C.F.R. Part 522). This rule amends the animal drug regulations to reflect approval of an original new animal drug application providing for veterinary prescription use of a combination injectable solution containing florfenicol and flunixin meglumine in cattle. View this document.

75 Fed. Reg. 1274 (January 11, 2010) (final rule) (to be codified at 21 C.F.R. Part 522). This rule amends the animal drug regulations to reflect approval of a supplemental new animal drug application providing for a revised human food safety warning for use of hyaluronate sodium injectable solution in horses. View this document.

75 Fed. Reg. 1275 (January 11, 2010) (final rule) (to be codified at 21 C.F.R. Part 522). This rule amends the animal drug regulations to reflect approval of a supplemental new animal drug application providing for administering ractopamine hydrochloride Type C medicated feeds as a top dress to cattle fed in confinement for slaughter. View this document.

75 Fed. Reg. 383 (January 5, 2010) (notice). This notice announces the extension of a temporary permit to market test products designated as "skinless and boneless sockeye salmon" that deviate from the U.S. standard of identity for canned Pacific salmon. View this document.

74 Fed. Reg. 69106 (December 30, 2009) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of information on the data elements for the Pet Food Early Warning Recall Rational Questionnaire. View this document.

74 Fed. Reg. 68629 (December 28, 2009) (notice). The Food and Drug Administration is announcing the availability of a draft guidance document entitled "Tobacco Health Document Submission." View this document.

74 Fed. Reg. 67877 (December 21, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance entitled "Timeframe for Submission of Tobacco Health Documents." View this document.

74 Fed. Reg. 66914 (December 17, 2009) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for use of two-way combination Type B and C medicated swine feeds formulated with ractopamine hydrochloride and tylosin phosphate. View this document.

74 Fed. Reg. 66979 (December 17, 2009) (notice). The Food and Drug Administration is announcing the filing of a petition proposing that the food additive regulations be amended to provide for the safe use of vitamin D2 bakers yeast as a dual purpose nutrient supplement and leavening agent or dough relaxer in yeast-containing baked products. View this document.

74 Fed. Reg. 66573 (December 16, 2009) (final rule) (to be codified at 21 C.F.R. Part 522). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application adding Mycoplasma bovis to the bovine respiratory disease pathogens for which florfenicol injectable solution is approved as a treatment. View this document.

74 Fed. Reg. 65129 (December 9, 2009) (notice). The Food and Drug Administration is establishing a public docket to obtain information on suggested elements for approved tobacco retailer training programs. View this document.

74 Fed. Reg. 64091 (December 7, 2009) (notice). The Food and Drug Administration is announcing that Kemira Oyj has filed a petition proposing that the food additive regulations be amended to provide for the safe use of formic acid as a pH control agent in swine feed. View this document.

74 Fed. Reg. 63759 (December 4, 2009) (notice). The Food and Drug Administration is announcing the availability of a draft guidance entitled "Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods." View this document.

74 Fed. Reg. 63154 (December 2, 2009) (notice). The Food and Drug Administration is announcing an opportunity for public comment on a proposed collection of information on the Manufactured Food Regulatory Program Standards. View this document.

74 Fed. Reg. 62786 (December 1, 2009) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to the Office of Management and Budget for review and clearance: Experimental Studies of Nutrition Symbols on Food Packages. View this document.

74 Fed. Reg. 62795 (December 1, 2009) (notice). The Food and Drug Administration is announcing the availability of draft Compliance Policy Guide Sec. 527.300 Dairy Products--Microbial Contaminants and Alkaline Phosphatase Activity. View this document.

74 Fed. Reg. 62795 (December 1, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance entitled "Listing of Ingredients in Tobacco Products." View this document.

74 Fed. Reg. 62490 (November 30, 2009) (final rule) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application providing for use of generic chlortetracycline soluble powder to make medicated drinking water for cattle, swine, chickens, and turkeys. View this document.

74 Fed. Reg. 62329 (November 27, 2009) (notice). The Food and Drug Administration is announcing the availability of a draft guidance entitled "Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act." View this document.

74 Fed. Reg. 61029 (November 23, 2009) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for use of the same dose levels approved for single-ingredient Type C medicated feeds containing melengestrol acetate, monensin, or tylosin phosphate for heifers fed in confinement for slaughter in three-way, combination drug Type C medicated feeds containing melengestrol acetate, monensin, and tylosin phosphate. View this document.

74 Fed. Reg. 61068 (November 23, 2009) (proposed rule) (to be codified at 21 C.F.R. Part 501). The Food and Drug Administration is proposing to amend its regulations regarding the declaration of certified color additives on the labels of animal food including animal feeds and pet foods. View this document.

74 Fed. Reg. 60155 (November 20, 2009) (final rule) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application providing for use of Sulfadimethoxine Soluble Powder in medicated drinking water of cattle, chickens, and turkeys. View this document.

74 Fed. Reg. 60277 (November 20, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance for industry 191 entitled "Changes to Approved NADAs--New NADAs vs. Category II Supplemental NADAs." View this document.

74 Fed. Reg. 59911 (November 19, 2009) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for use of the same increased dose levels approved for single-ingredient Type C medicated feeds for heifers fed in confinement for slaughter containing melengestrol acetate or monensin in two-way, combination drug Type C medicated feeds containing melengestrol acetate and monensin. View this document.

74 Fed. Reg. 59558 (November 18, 2009) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of certain information related to "Real Time" surveys of consumers' knowledge, perceptions, and beliefs concerning foodborne illness outbreaks or food recalls. View this document.

74 Fed. Reg. 59553 (November 18, 2009) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of certain information related to an experimental study of Nutrition Facts label formats. View this document.

74 Fed. Reg. 59579 (November 18, 2009) (notice). The Food and Drug Administration is extending to January 25, 2010, the comment period for the notice entitled "Acrylamide in Food; Request for Comments and for Scientific Data and Information." View this document.

74 Fed. Reg. 59188 (November 17, 2009) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted for review and clearance: Gluten-Free Labeling of Food Products Experimental Study. View this document.

74 Fed. Reg. 58843 (November 16, 2009) (final rule) (to be codified at 21 C.F.R. Part 73). The Food and Drug Administration is amending the color additive regulations to provide for the safe use of paracoccus pigment as a color additive in the feed of salmonid fish to enhance the color of their flesh. View this document.

74 Fed. Reg. 58027 (November 10, 2009) (notice). The Food and Drug Administration is providing notice of a memorandum of understanding between FDA and the National Oceanic and Atmospheric Administration related to the inspection of fish and fishery products and establishments. View this document.

74 Fed. Reg. 57248 (November 5, 2009) (final rule) (to be codified at 21 C.F.R. Part 73). The Food and Drug Administration is amending the color additive regulations to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive in the feed of salmonid fish to enhance the color of their flesh. View this document.

74 Fed. Reg. 57180 (November 4, 2009) (notice; extension of comment period). The Food and Drug Administration is extending to January 4, 2010, the comment period for the draft guidance entitled "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens." View this document.

74 Fed. Reg. 57179 (November 4, 2009) (notice; extension of comment period). The Food and Drug Administration is extending to January 4, 2010, the comment period for the draft guidance entitled "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons." View this document.

74 Fed. Reg. 57179 (November 4, 2009) (notice; extension of comment period). The Food and Drug Administration is extending to January 4, 2010, the comment period for the draft guidance entitled "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes." View this document.

74 Fed. Reg. 56842 (November 3, 2009) (notice). The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Listing of Ingredients in Tobacco Products." View this document.

74 Fed. Reg. 56843 (November 3, 2009) (notice; request for comment). This notice announces a public meeting regarding product tracing systems for food intended for humans and animals. View this document.

74 Fed. Reg. 55550 (October 28, 2009) (notice). This notice solicits comments on the medicated feed mill licensing applications. View this document.

74 Fed. Reg. 55557 (October 28, 2009) (notice). The Food and Drug Administration is announcing that a proposed collection of information regarding recordkeeping requirements for microbiological testing and corrective measures for bottled water has been submitted for review and clearance. View this document.

74 Fed. Reg. 55050 (October 26, 2009) (notice). This notice solicits comments on the proposed extension of an existing collection of information pertaining to the tobacco product standard for flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act. View this document.

74 Fed. Reg. 55046 (October 26, 2009) (notice). This notice solicits comments on reporting and recordkeeping requirements for antimicrobial animal drug distribution as required by Section 105 of the Animal Drug User Fee Amendments of 2008. View this document.

74 Fed. Reg. 54749 (October 23, 2009) (direct final rule) (to be codified at 21 C.F.R. Part 514). The Food and Drug Administration is amending the regulations regarding new animal drug applications to provide that NADAs shall be submitted in the described form, as appropriate for the particular submission. View this document.

74 Fed. Reg. 54771 (October 23, 2009) (proposed rule) (to be codified at 21 C.F.R. Part 514). The Food and Drug Administration is proposing to amend the regulations regarding new animal drug applications to provide that NADAs shall be submitted in the form and containing the information described, as appropriate for the particular submission. View this document.

74 Fed. Reg. 54827 (October 23, 2009) (notice). This notice solicits comments on the information collection requirements of FDA's regulations that require records on FDA-regulated human food, including dietary supplements, and cosmetics that are manufactured from, processed with, or otherwise contain, material derived from cattle. View this document.

74 Fed. Reg. 53746 (October 20, 2009) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of certain information related to FDA's third party disclosure and recordkeeping requirements for reportable food. View this document.

74 Fed. Reg. 53743 (October 20, 2009) (notice). The Food and Drug Administration is announcing that a proposed collection of information has been submitted for review and clearance: Food Labeling Regulations (OMB Control Number 0910-0381)-Extension. View this document.

74 Fed. Reg. 53164 (October 16, 2009) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 522). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for veterinary prescription use of tulathromycin injectable solution for the control of swine respiratory disease in groups of pigs where it has been diagnosed. View this document.

74 Fed. Reg. 52885 (October 15, 2009) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application revising limitations for liquid Type B medicated cattle feeds containing tylosin phosphate. View this document.

74 Fed. Reg. 51610 (October 7, 2009) (notice). The Food and Drug Administration is announcing the availability of the draft guidance entitled "Guidance for Industry: Ingredients Declared as Evaporated Cane Juice." View this document.

74 Fed. Reg. 51287 (October 6, 2009) (notice). This notice solicits comments on the proposed collection of certain information related to food additive petitions regarding animal feed. View this document.

74 Fed. Reg. 51160 (October 5, 2009) (notice). The Food and Drug Administration is announcing the availability of the draft guidance entitled "The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act." View this document.

74 Fed. Reg. 51161 (October 5, 2009) (notice). The Food and Drug Administration is announcing a second public meeting to discuss issues related to transparency at the agency. View this document.

74 Fed. Reg. 47592 (September 16, 2009) (notice). The Food and Drug Administration is amending the filing notice for a food additive petition to provide for the safe use of ionizing radiation for control of foodborne pathogens in crustaceans and processed crustaceans. View this document.

74 Fed. Reg. 47256 (September 15, 2009) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to OMB for review and clearance: Food Safety Survey. View this document.

74 Fed. Reg. 47257 (September 15, 2009) (notice). This document corrects an error in the submission date for comments in a notice published on September 1, 2009, that announced the proposed collection of information concerning the submission of tobacco product establishment registration and submission of certain health information. View this document.

74 Fed. Reg. 46434 (September 9, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance document entitled "Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007." View this document.

74 Fed. Reg. 46440 (September 9, 2009) (notice). This notice requests that any industry organizations interested in participating in the selection of a pool of nonvoting industry representative candidates available to serve as temporary nonvoting members on its Risk Communication Advisory Committee for the Office of the Commissioner notify FDA in writing. View this document.

74 Fed. Reg. 45221 (September 1, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance document entitled "Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act." View this document.

74 Fed. Reg. 44750 (August 31, 2009) (notice of public meetings). The Food and Drug Administration is announcing two public meetings to discuss the final rule concerning the prevention of Salmonella Enteritidis in shell eggs during production, storage, and transportation. View this document.

74 Fed. Reg. 43714 (August 27, 2009) (notice; reopening of comment period). The Food and Drug Administration is reopening until September 29, 2009, the comment period for the notice published on January 21, 2009, which requested comments and scientific data and information that would assist in the conduct of a risk assessment of the public health impact of foodborne Listeria monocytogenes in some ready-to-eat foods sliced, prepared, and/or packaged in retail facilities. View this document.

74 Fed. Reg. 43042 (August 26, 2009) (final rule) (to be codified at 21 C.F.R. Part 14). The Food and Drug Administration is announcing the Establishment of the Tobacco Products Scientific Advisory Committee. View this document.

74 Fed. Reg. 43134 (August 26, 2009) (notice; request for comments and scientific data and information). The Food and Drug Administration is considering issuing guidance for industry on reduction of acrylamide levels in food products, and is requesting comments and scientific data and information on acrylamide in food. View this document.

74 Fed. Reg. 43140 (August 26, 2009) (notice). The Food and Drug Administration is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on its Tobacco Products Scientific Advisory Committee notify FDA in writing. View this document.

74 Fed. Reg. 43147 (August 26, 2009) (notice). The Food and Drug Administration is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee in the Office of Science, Center for Tobacco Products. View this document.

74 Fed. Reg. 42676 (August 24, 2009) (notice). The Food and Drug Administration is announcing an opportunity for public comment a proposed collection of certain information on the Internet Survey on Barriers to Food Label Use. View this document.

74 Fed. Reg. 42311 (August 21, 2009) (notice; correction). The Food and Drug Administration is correcting the date for submitting written or electronic comments on the draft guidance, "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens." View this document.

74 Fed. Reg. 42311 (August 21, 2009) (notice; correction). The Food and Drug Administration is correcting the date for submitting written or electronic comments on the draft guidance, "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons." View this document.

74 Fed. Reg. 42311 (August 21, 2009) (notice; correction). The Food and Drug Administration is correcting the date for submitting written or electronic comments on the draft guidance, "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes." View this document.

74 Fed. Reg. 41631 (August 18, 2009) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of an original new animal drug application providing for use of single-ingredient Type A medicated articles containing semduramyicin and virginiamycin to manufacture 2-way combination drug Type C medicated feeds for use in broiler chickens. View this document.

74 Fed. Reg. 41711 (August 18, 2009) (notice). The Food and Drug Administration is announcing that a collection of information entitled "Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use" has been approved by OMB. View this document.

74 Fed. Reg. 41710 (August 18, 2009) (notice). The Food and Drug Administration is announcing that a collection of information entitled "Irradiation in the Production, Processing, and Handling of Food" has been approved by OMB. View this document.

74 Fed. Reg. 41710 (August 18, 2009) (notice). The Food and Drug Administration is announcing that a collection of information entitled "Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices" has been approved by OMB. View this document.

74 Fed. Reg. 41711 (August 18, 2009) (notice; correction). This document corrects an error in the document announcing the Fiscal Year 2010 fee rates for the Animal Drug User Fee Act. View this document.

74 Fed. Reg. 41711 (August 18, 2009) (notice; reopening of comment period). The Food and Drug Administration is reopening until November 6, 2009, the comment period on ways in which FDA can make useful and understandable information about FDA activities and decision making more readily available to the public. View this document.

74 Fed. Reg. 41713 (August 18, 2009) (notice). The Food and Drug Administration has reorganized the Office of the Commissioner, including re-alignment of four Deputy-level offices: the Office of the Chief Scientist; the Office of Administration; the Office of Foods; and the Office of Policy, Planning and Budget. View this document.

74 Fed. Reg. 41438 (August 17, 2009) (notice). The Food and Drug Administration is announcing the availability of a draft guidance document entitled "Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration." View this document.

74 Fed. Reg. 40723 (August 13, 2009) (final rule) (to be codified at 21 C.F.R. Part 588). The FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for the use of fixed-combination Type A medicated articles containing oxytetracycline and neomycin sulfate to formulate two-way, fixed-combination drug Type B and Type C medicated feeds for chickens, turkeys, swine, cattle, and sheep. View this document.

74 Fed. Reg. 40211 (August 11, 2009) (notice). The Food and Drug Administration is announcing a program to support public health protection by facilitating the timely issuance of warning letters. View this document.

74 Fed. Reg. 38634 (August 4, 2009) (notice). The Food and Drug Administration is announcing that a collection of information entitled Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act has been approved by OMB. View this document.

74 Fed. Reg. 38429 (August 3, 2009) (notice). The Food and Drug Administration is announcing the rates and payment procedures for fiscal year 2010 animal drug user fees. View this document.

74 Fed. Reg. 38434 (August 3, 2009) (notice). The Food and Drug Administration is announcing the rates and payment procedures for fiscal year 2010 generic new animal drug user fees. View this document.

74 Fed. Reg. 38439 (August 3, 2009) (notice). The Food and Drug Administration is announcing the availability of a draft guidance entitled "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens." View this document.

74 Fed. Reg. 38437 (August 3, 2009) (notice). The Food and Drug Administration is announcing the availability of a draft guidance entitled "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons." View this document.

74 Fed. Reg. 38438 (August 3, 2009) (notice). The Food and Drug Administration is announcing the availability of a draft guidance entitled "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes." View this document.

74 Fed. Reg. 38462 (August 3, 2009) (notice). The Food and Drug Administration is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2009 to the University of Florida for the support of the Seafood Hazard Analysis and Critical Control Points Alliance for Education and Training. View this document.

74 Fed. Reg. 36229 (July 22, 2009) (notice). The Food and Drug Administration is announcing that a collection of information entitled "Export of Food and Drug Administration Regulated Products: Export Certificates" has been approved. View this document.

74 Fed. Reg. 36229 (July 22, 2009) (notice). The Food and Drug Administration is announcing that a collection of information entitled "Food Contact Substances Notification System" has been approved. View this document.

74 Fed. Reg. 36241 (July 22, 2009) (notice). The Food and Drug Administration is withdrawing approval of two new animal drug applications and an abbreviated new animal drug application for ketamine, S-Methoprene, and Nitazoxanide. View this document.

74 Fed. Reg. 35871 (July 21, 2009) (notice). The Food and Drug Administration is announcing that a petition was filed proposing that the food additive regulations be amended to provide for the safe use of N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl-[alpha]-aspartyl]-L-phenylalanine 1-methyl ester, monohydrate for use as a non-nutritive sweetener in tabletop applications and powdered beverage mixes. View this document.

74 Fed. Reg. 35196 (July 20, 2009) (notice). The Food and Drug Administration is announcing that a collection of information entitled "Record Retention Requirements for the Soy Protein and Coronary Heart Disease Health Claim" has been approved by OMB. View this document.

74 Fed. Reg. 34236 (July 15, 2009) (final rule) (to be codified at 21 C.F.R. Part 522). This rule amends the animal drug regulations to reflect approval of an original abbreviated new animal drug application providing for the use of flunixin meglumine injectable solution in swine. View this document.

74 Fed. Reg. 34236 (July 15, 2009) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 588). This rule amends the animal drug regulations to reflect approval of an original new animal drug application providing for use of single-ingredient Type A medicated articles containing lasalocid and roxarsone to formulate two-way combination drug Type C medicated feeds for use in growing turkeys. View this document.

74 Fed. Reg. 34235 (July 15, 2009) (final rule) (to be codified at 21 C.F.R. Parts 510 and 522). This rule amends the animal drug regulations to reflect approval of an original abbreviated new animal drug application providing for the use of ceftiofur sodium powder for injection as a solution in dogs, horses, cattle, swine, day old chickens, turkey poults, sheep, and goats as therapy for various bacterial infections. View this document.

74 Fed. Reg. 34353 (July 15, 2009) (notice). This notice announces an opportunity for public comment on the proposed collection of information related to FDA's food labeling regulations and Form FDA 3570, "Model Small Business Nutrition Labeling Exemption Notice." View this document.

74 Fed. Reg. 34024 (July 14, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance document entitled "Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act." View this document.

74 Fed. Reg. 33029 (July 9, 2009) (final rule) (to be codified at 21 C.F.R. Parts 16 and 118). This rule requires shell egg producers to implement measures to prevent Salmonella Enteritidis from contaminating eggs on the farm and from further growth during storage and transportation, and requires these producers to maintain records concerning their compliance with the rule and to register with FDA. View this document.

74 Fed. Reg. 31457 (July 1, 2009) (notice; request for comments). The Food and Drug Administration is establishing a public docket to obtain information on the implementation of the Family Smoking Prevention and Tobacco Control Act. View this document.

74 Fed. Reg. 31038 (June 29, 2009) (notice). The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient." View this document.

74 Fed. Reg. 30603 (June 26, 2009) (notice). The Food and Drug Administration is announcing three public workshops to discuss the draft guidance FDA issued on June 11, 2009, concerning the Congressionally-mandated Reportable Food Registry. View this document.

74 Fed. Reg. 30211 (June 25, 2009) (final rule; correction) (to be codified at 21 C.F.R. Parts 129 and 165). The Food and Drug Administration is correcting a final rule related to bottled water published on May 29, 2009, that contained an inadvertent error in the "Analysis of Impacts" section. View this document.

74 Fed. Reg. 28498 (June 16, 2009) (notice). This notice solicits comments on the proposed collection of information associated with the draft guidance document entitled "Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007." View this document.

74 Fed. Reg. 27019 (June 12, 2009) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for revised Blue Bird labeling for chlortetracycline Type A medicated articles used to formulate Type B and Type C medicated feeds in various classes of livestock and poultry. View this document.

74 Fed. Reg. 27803 (June 11, 2009) (notice). The Food and Drug Administration is announcing the availability of a draft guidance entitled "Guidance for Industry: Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007." View this document.

74 Fed. Reg. 27276 (June 9, 2009) (notice). This notice announces a public meeting to present the background, approach, scope, and data needs for a recently initiated interagency risk assessment of the public health impact of foodborne Listeria monocytogenes in some ready-to-eat foods that are sliced, prepared, or packaged in retail facilities. View this document.

74 Fed. Reg. 26712 (June 3, 2009) (notice). The Food and Drug Administration is announcing a public meeting to solicit recommendations from interested persons on ways in which FDA can make useful and understandable information about FDA activities and decisionmaking more readily available to the public. View this document.

74 Fed. Reg. 26407 (June 2, 2009) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of certain information on provisions of the Interstate Shellfish Dealers Certificate. View this document.

74 Fed. Reg. 26406 (June 2, 2009) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of certain information on provisions of the regulation requiring manufacturers, packers, and distributors of dietary supplements to notify FDA that they are marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act. View this document.

74 Fed. Reg. 26408 (June 2, 2009) (notice). The Food and Drug Administration is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2009 to the Illinois Institute of Technology to support the National Center for Food Safety and Technology. View this document.

74 Fed. Reg. 26244 (June 1, 2009) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of certain information by the agency, Experimental Study of Nutrition Symbols on Food Packages. View this document.

74 Fed. Reg. 26252 (June 1, 2009) (notice). This notice announces the availability of a guidance for industry entitled "Bottled Water: Residual Disinfectants and Disinfection Byproducts--Small Entity Compliance Guide" for a direct final rule published in the Federal Register of March 28, 2001. View this document.

74 Fed. Reg. 25651 (May 29, 2009) (final rule) (to be codified at 21 C.F.R. Parts 129 and 165). The Food and Drug Administration is amending its bottled water regulations regarding testing of the source water and finished bottled water products for coliform and E. coli, the applicable adulteration provision, and appropriate measures to rectify or eliminate the causes of E. coli contamination. View this document.

74 Fed. Reg. 25752 (May 29, 2009) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the following proposed collection of certain information: Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water--21 CFR 129.35(a)(3)(i), 129.80(g), and 129.80(h). View this document.

74 Fed. Reg. 23865 (May 21, 2009) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to the Office of Management and Budget for review and clearance: Irradiation in the Production, Processing, and Handling of Food--Extension. View this document.

74 Fed. Reg. 22942 (May 15, 2009) (notice). The Food and Drug Administration is requesting nominations for voting consumer representatives to serve on the Food Advisory Committee. View this document.

74 Fed. Reg. 22942 (May 15, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance for industry entitled "Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis--Small Entity Compliance Guide." View this document.

74 Fed. Reg. 22752 (May 14, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance document for industry entitled "Animal Generic Drug User Fees and Fee Waivers and Reductions." View this document.

74 Fed. Reg. 21808 (May 11, 2009) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to the Office of Management and Budget for review and clearance: Substances Generally Recognized as Safe: Notification Procedure-Extension. View this document.

74 Fed. Reg. 20955 (May 6, 2009) (notice). The Food and Drug Administration is announcing the availability of a Compliance Policy Guide entitled "Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." View this document.

74 Fed. Reg. 20963 (May 6, 2009) (notice). This notice announces a forthcoming meeting of the Transmissible Spongiform Encephalopathies Advisory Committee, which will be open to the public. View this document.

74 Fed. Reg. 20583 (May 5, 2009) (final rule; confirmation of effective date; correction) (to be codified at 21 C.F.R. Part 589). The Food and Drug Administration is correcting a final rule, confirmation of effective date, which had confirmed the effective date of April 27, 2009, for a final rule entitled "Substances Prohibited From Use in Animal Food or Feed." View this document.

74 Fed. Reg. 20324 (May 1, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance for industry 195 entitled "Small Entities Compliance Guide for Renderers--Substances Prohibited From Use in Animal Food or Feed." View this document.

74 Fed. Reg. 19972 (April 30, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance for industry entitled "Bottled Water: Arsenic--Small Entity Compliance Guide" for a final rule published in the Federal Register of June 9, 2005. View this document.

74 Fed. Reg. 19972 (April 30, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance for industry entitled "Bottled Water: Uranium--Small Entity Compliance Guide" for a direct final rule published in the Federal Register of March 3, 2003. View this document.

74 Fed. Reg. 19973 (April 30, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance for industry entitled "Cochineal Extract and Carmine: Declaration by Name on the Label of All Foods and Cosmetic Products That Contain These Color Additives--Small Entity Compliance Guide." View this document.

74 Fed. Reg. 19231 (April 28, 2009) (notice). This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration. The meeting will be open to the public. View this document.

74 Fed. Reg. 19096 (April 27, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance for industry entitled "Target Animal Safety for Veterinary Pharmaceutical Products," VICH GL43. View this document.

74 Fed. Reg. 18626 (April 24, 2009) (final rule; confirmation of effective date). The Food and Drug Administration is confirming the effective date of April 27, 2009, for the final rule that published on April 25, 2008, entitled "Substances Prohibited From Use in Animal Food or Feed." The agency is also establishing a compliance date of October 26, 2009, for this rule. View this document.

74 Fed. Reg. 18736 (April 24, 2009) (notice). The Food and Drug Administration is announcing the availability of a small entity compliance guide entitled, "What You Need to Know About Prior Notice of Imported Food Shipments--A Small Entity Compliance Guide." View this document.

74 Fed. Reg. 17770 (April 17, 2009) (final rule) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for a revised human food safety warning for use of fenbendazole suspension in horses. View this document.

74 Fed. Reg. 17868 (April 17, 2009) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to OMB for review and clearance: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use (Extension). View this document.

74 Fed. Reg. 17871 (April 17, 2009) (notice). The Food and Drug Administration is announcing that a collection of information entitled "Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body" has been approved. View this document.

74 Fed. Reg. 16160 (April 9, 2009) (notice of proposed delay of effective date). The Food and Drug Administration is seeking public comment on a contemplated delay of 60 days in the effective date of the rule entitled "Substances Prohibited From Use in Animal Food or Feed," published on April 25, 2008. View this document.

74 Fed. Reg. 15736 (April 7, 2009) (notice). The Food and Drug Administration is announcing the rates and payment procedures for fiscal year 2009 generic new animal drug user fees. View this document.

74 Fed. Reg. 15497 (April 6, 2009) (notice of public meeting; request for comment). The Food and Drug Administration is announcing a public meeting pertaining to economically motivated adulteration. View this document.

74 Fed. Reg. 14135 (March 30, 2009) (notice). The following proposed collection of information has been submitted to OMB for review and clearance: Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT. View this document.

74 Fed. Reg. 13213 (March 26, 2009) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to OMB for emergency processing: Guidance for Industry: Animal Generic Drug User Fees and Fee Waivers and Reductions. View this document.

74 Fed. Reg. 12364 (March 24, 2009) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to OMB for review and clearance: Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices. View this document.

74 Fed. Reg. 11961 (March 20, 2009) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted to OMB: Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments. View this document.

74 Fed. Reg. 11643 (March 19, 2009) (final rule) (to be codified at 21 C.F.R. Part 522). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for changing scientific nomenclature for a bovine pathogen on labeling for tylosin injectable solution. View this document.

74 Fed. Reg. 11476 (March 18, 2009) (final rule) (to be codified at 21 C.F.R. Part 172). The Food and Drug Administration is amending the food additive regulations to provide for the safe use of an aqueous solution of silver nitrate and hydrogen peroxide as an antimicrobial agent in bottled water. View this document.

74 Fed. Reg. 11019 (March 16, 2009) (final rule) (to be codified at 21 C.F.R. Part 172). The Food and Drug Administration is amending the food additive regulations to provide for the safe use of vitamin D2 as a nutrient supplement in soy-based food products. View this document.

74 Fed. Reg. 11117 (March 16, 2009) (notice). The Food and Drug Administration is announcing the availability of the draft guidance entitled "User Fees and Refunds for Premarket Approval Applications." View this document.

74 Fed. Reg. 11118 (March 16, 2009) (notice). The Food and Drug Administration is announcing the availability of a draft guidance for industry 197 entitled "Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files." View this document.

74 Fed. Reg. 10483 (March 11, 2009) (final rule; confirmation of effective date). The Food and Drug Administration is confirming the effective date of January 5, 2011, for the final rule amending the regulations for cochineal extract and carmine by requiring their declaration by name on the label of all food and cosmetic products that contain these color additives. View this document.

74 Fed. Reg. 10483 (March 11, 2009) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application providing for the use of generic amprolium concentrate solution to make medicated drinking water for chickens and turkeys for the treatment of coccidiosis. View this document.

74 Fed. Reg. 10596 (March 11, 2009) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of certain information by the agency concerning the Animal Generic Drug User Fee Cover Sheet Form FDA 3728. View this document.

74 Fed. Reg. 10598 (March 11, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance entitled "Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an Ingredient." View this document.

74 Fed. Reg. 10255 (March 10, 2009) (notice). The Food and Drug Administration is announcing that the following collection of information has been submitted to OMB: General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions (Extension). View this document.

74 Fed. Reg. 9766 (March 6, 2009) (final rule) (to be codified at 21 C.F.R. Parts 510 and 529). The Food and Drug Administration is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application from Schering-Plough Animal Health, Inc., to Medical Developments International, Ltd. View this document.

74 Fed. Reg. 9822 (March 6, 2009) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed voluntary consumer study entitled "Gluten-Free Labeling of Food Products Experimental Study." View this document.

74 Fed. Reg. 9618 (March 5, 2009) (notice). The Food and Drug Administration is announcing that the following proposed collection of information has been submitted for review and clearance: Survey to Evaluate the Effectiveness of Mississippi Delta Fish Advisories. View this document.

74 Fed. Reg. 9618 (March 5, 2009) (notice). This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration, which will be open to the public. View this document.

74 Fed. Reg. 9049 (March 2, 2009) (final rule) (to be codified at 21 C.F.R. Part 522). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application that adds claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a 1-percent ivermectin solution by subcutaneous injection. View this document.

74 Fed. Reg. 8549 (February 25, 2009) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of certain information by the agency related to the Importer's Entry Notice. View this document.

74 Fed. Reg. 8200 (February 24, 2009) (direct final rule; confirmation of effective date). The Food and Drug Administration is confirming the effective date of March 27, 2009, for the direct final rule that updates the statutory citations regarding civil monetary penalties. View this document.

74 Fed. Reg. 8093 (February 23, 2009) (notice). This notice announces a forthcoming meeting of the Allergenic Products Advisory Committee of the Food and Drug Administration. View this document.

74 Fed. Reg. 7180 (February 13, 2009) (final rule) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for changes to the labeling of tiamulin concentrate solution used in drinking water for swine. View this document.

74 Fed. Reg. 7236 (February 13, 2009) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the following proposed collection of certain information: Irradiation in the Production, Processing, and Handling of Food (Extension). View this document.

74 Fed. Reg. 6993 (February 12, 2009) (final rule) (to be codified at 21 C.F.R. Part 522). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application providing for the veterinary prescription use of flunixin meglumine solution by intravenous injection in dairy cattle for control of pyrexia associated with acute bovine mastitis. View this document.

74 Fed. Reg. 6823 (February 11, 2009) (final rule) (to be codified at 21 C.F.R. Parts 510 and 528). The Food and Drug Administration is amending the animal drug regulations to reflect the original approval of a new animal drug application providing for use of a recombinant deoxyribonucleic acid construct in a lineage of genetically engineered goats expressing recombinant human antithrombin in their milk. View this document.

74 Fed. Reg. 6894 (February 11, 2009) (notice). The FDA has submitted the following information collection requirement to OMB for review and clearance: Substances Generally Recognized as Safe: Notification Procedure-21 C.F.R. 170.36 and 570.36. View this document.

74 Fed. Reg. 6902 (February 11, 2009) (notice). The Food and Drug Administration is announcing the availability of a revised guidance document entitled "Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association." View this document.

74 Fed. Reg. 6541 (February 10, 2009) (final rule) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application providing for use of ivermectin oral paste for the treatment and control of additional species of gastrointestinal parasites in horses. View this document.

74 Fed. Reg. 6641 (February 10, 2009) (notice). The Food and Drug Administration is announcing a public workshop entitled "Food Labeling Workshop" which will provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups. View this document.

74 Fed. Reg. 6641 (February 10, 2009) (notice). The Food and Drug Administration is announcing a public workshop entitled "Food Protection Workshop" which will provide information about food safety, food defense, the regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and other subjects related to the Food Protection Plan. View this document.

74 Fed. Reg. 4039 (January 22, 2009) (notice). The Food and Drug Administration is announcing the availability of Compliance Policy Guide Sec. 540.370-Fish and Fishery Products-Decomposition. View this document.

74 Fed. Reg. 3615 (January 21, 2009) (notice). The Food and Drug Administration is announcing the availability of two draft documents: "Report of Quantitative Risk and Benefit Assessment of Commercial Fish Consumption, Focusing on Fetal Neurodevelopmental Effects (Measured by Verbal Development in Children) and on Coronary Heart Disease and Stroke in the General Population" and "Summary of Published Research on the Beneficial Effects of Fish Consumption and Omega-3 Fatty Acids for Certain Neurodevelopmental and Cardiovascular Endpoints." View this document.

74 Fed. Reg. 3617 (January 21, 2009) (notice; request for comments and for scientific data and information). The Food and Drug Administration is requesting comments and scientific data and information that would assist the agency in its plans to conduct a risk assessment of the public health impact of foodborne Listeria monocytogenes in some ready-to-eat foods sliced, prepared, and/or packaged in retail facilities. View this document.

74 Fed. Reg. 3057 (January 16, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance for industry 187 entitled "Regulation of Genetically Engineered Animals Containing Heritable recombinant DNA Constructs." View this document.

74 Fed. Reg. 3058 (January 16, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance for industry entitled "Voluntary Third-Party Certification Programs for Foods and Feeds." View this document.

74 Fed. Reg. 3059 (January 16, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance document entitled "Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims." View this document.

74 Fed. Reg. 3060 (January 16, 2009) (notice; withdrawal). The Food and Drug Administration is announcing the withdrawal of a guidance entitled "Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements." View this document.

74 Fed. Reg. 3060 (January 16, 2009) (notice; withdrawal). The Food and Drug Administration is announcing the withdrawal of the guidance entitled "Guidance for Industry and FDA: Interim Evidence-Based Ranking System for Scientific Data." View this document.

74 Fed. Reg. 2243 (January 15, 2009) (proposed rule) (to be codified at 21 C.F.R. Part 131). The Food and Drug Administration is proposing to revoke its regulations on the standards of identity for lowfat yogurt and nonfat yogurt and amend the standard of identity for yogurt in numerous respects. View this document.

74 Fed. Reg. 2598 (January 15, 2009) (notice). The Food and Drug Administration is announcing that a proposed collection of information has been submitted to the Office of Management and Budget: Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles. View this document.

74 Fed. Reg. 2600 (January 15, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance document entitled "Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association." View this document.

74 Fed. Reg. 2079 (January 14, 2009) (notice). The Food and Drug Administration is announcing that a proposed collection of information has been submitted to the Office of Management and Budget: Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim. View this document.

74 Fed. Reg. 2080 (January 14, 2009) (notice). Food and Drug Administration is announcing that a proposed collection of information has been submitted to the Office of Management and Budget: Filing Objections and Requests for a Hearing on a Regulation or Order. View this document.

74 Fed. Reg. 1692 (January 13, 2009) (notice). The Food and Drug Administration is announcing on behalf of several members of the Interagency Working Group on Import Safety the availability of a draft guidance for industry entitled "Good Importer Practices." View this document.

74 Fed. Reg. 906 (January 9, 2009) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of certain information associated with the early food safety evaluation of new non-pesticidal proteins produced by new plant varieties intended for food use. View this document.

74 Fed. Reg. 207 (January 5, 2009) (final rule) (to be codified at 21 C.F.R. Parts 73 and 101). The Food and Drug Administration is revising its requirements for cochineal extract and carmine by requiring their declaration by name on the label of all food and cosmetic products that contain these color additives. View this document.

74 Fed. Reg. 304 (January 5, 2009) (notice). The Food and Drug Administration is announcing the availability of a guidance entitled "Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act." View this document.

74 Fed. Reg. 6 (January 2, 2009) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications providing for removal of a 250-pound weight restriction and the addition of a reproductive caution statement to labeling of tiamulin medicated feeds used for swine. View this document.

73 Fed. Reg. 78958 (December 24, 2008) (correction) (to be codified at 21 C.F.R. Part 573). This document provides a CFR correction in the rules for food additives permitted in feed and drinking water of animals. View this document.

73 Fed. Reg. 77721 (December 19, 2008) (notice). This notice solicits comments on the information collection provisions of the agency's Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments. View this document.

73 Fed. Reg. 76946 (December 18, 2008) (final rule) (to be codified at 40 C.F.R. Part 180). This rule amends the animal drug regulations to reflect approval of two supplemental new animal drug applications providing for use of tylosin tartrate soluble powder in drinking water of swine followed by tylosin phosphate in medicated swine feed for the treatment and control of swine dysentery and the control of porcine proliferative enteropathies. View this document.

73 Fed. Reg. 76655 (December 17, 2008) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of certain information by the agency associated with the export of Food and Drug Administration regulated products. View this document.

73 Fed. Reg. 76658 (December 17, 2008) (notice). The Food and Drug Administration is providing notice of a memorandum of understanding between the Office of the Assistant Secretary of Defense, the Veterans Health Administration, and the U.S. Food and Drug Administration. View this document.

73 Fed. Reg. 76363 (December 16, 2008) (notice). The Food and Drug Administration is announcing the availability of a draft guidance for industry 191 entitled "Changes to Approved NADAs-New NADAs vs. Category II Supplemental NADAs." View this document.

73 Fed. Reg. 76364 (December 16, 2008) (notice). The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic." View this document.

73 Fed. Reg. 75625 (December 12, 2008) (notice of withdrawal). The Food and Drug Administration is announcing the withdrawal of a certain advance notice of proposed rulemaking and proposed rules that published in the Federal Register more than 5 years ago. View this document.

73 Fed. Reg. 75323 (December 11, 2008) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for an increased level of monensin in four-way combination Type C medicated feeds containing ractopamine, melengestrol, monensin, and tylosin for heifers fed in confinement for slaughter; and a revision to bacterial pathogen nomenclature. View this document.

73 Fed. Reg. 75438 (December 11, 2008) (notice). The Food and Drug Administration is announcing the availability of a revised draft guidance document entitled "Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1." View this document.

73 Fed. Reg. 74349 (December 8, 2008) (final rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is establishing January 2, 2012, as the uniform compliance date for food labeling regulations that are issued between January 1, 2009, and December 31, 2010. View this document.

73 Fed. Reg. 73936 (December 4, 2008) (notice). FDA has submitted a proposed collection of information associated with the Food Contact Substances Notification System to OMB for review and clearance. View this document.

73 Fed. Reg. 73939 (December 4, 2008) (notice). FDA has submitted a proposed collection of information associated with regulations under the Federal Import Milk Act to OMB for review and clearance. View this document.

73 Fed. Reg. 72714 (December 1, 2008) (final rule) (to be codified at 21 C.F.R. Parts 556 and 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a new animal drug application providing for use of ractopamine hydrochloride Type A medicated articles to make Type B and Type C medicated feeds used for increased rate of weight gain and improved feed efficiency in finishing turkeys. View this document.

73 Fed. Reg. 71923 (November 26, 2008) (final rule; withdrawal). The Food and Drug Administration is revoking the order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals. View this document.

73 Fed. Reg. 72062 (November 26, 2008) (notice). The Food and Drug Administration is announcing the availability of a draft guidance for industry 195, entitled "Draft Guidance for Industry: Small Entities Compliance Guide for Renderers-Substances Prohibited From Use in Animal Food or Feed." View this document.

73 Fed. Reg. 71655 (November 25, 2008) (notice). The Food and Drug Administration is announcing the availability of revised Compliance Policy Guide Sec. 540.700 Processed and/or Blended Seafood Products. View this document.

73 Fed. Reg. 66293 (November 7, 2008) (final rule) (to be codified at 21 C.F.R. Part 1). The Food and Drug Administration is issuing a final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. View this document.

73 Fed. Reg. 66411 (November 7, 2008) (notice). The Food and Drug Administration is announcing the availability of a draft Compliance Policy Guide entitled "Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." View this document.

73 Fed. Reg. 64958 (October 31, 2008) (notice). The Food and Drug Administration is announcing that a collection of information entitled "Infant Formula Recall Regulations" has been approved by the Office of Management and Budget. View this document.

73 Fed. Reg. 64197 (October 29, 2008) (final rule) (to be codified at 21 C.F.R. Part 573). The Food and Drug Administration is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of methyl esters of conjugated linoleic acid as a source of fatty acids in swine diets. View this document.

73 Fed. Reg. 64338 (October 29, 2008) (notice). The Food and Drug Administration is announcing that a collection of information entitled "Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act" has been approved by the Office of Management and Budget. View this document.

73 Fed. Reg. 64338 (October 29, 2008) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of certain information by the agency on the waiver requirement procedures that are recommended by the agency for in vivo demonstration of bioequivalence of animal drugs in soluble powder oral dosage form products and type a medicated articles. View this document.

73 Fed. Reg. 63663 (October 27, 2008) (proposed rule) (to be codified at 21 C.F.R. Part 1). The Food and Drug Administration is correcting a proposed rule that would require owners or consignees to label imported food that is refused entry into the United States. The preamble to the proposed rule inadvertently omitted a reference. View this document.

73 Fed. Reg. 63487 (October 24, 2008) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of certain information by the agency concerning fishing and fish consumption habits in the Mississippi Delta region, as well as the respondents' awareness and understanding of the Regional Delta Advisory. View this document.

73 Fed. Reg. 63072 (October 23, 2008) (final rule; correction) (to be codified at 21 C.F.R. Part 589). The Food and Drug Administration is correcting a final rule that appeared in the Federal Register of April 25, 2008 amending the agency's regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals. It was inadvertently published with incorrect dollar amounts in two separate areas. View this document.

73 Fed. Reg. 63157 (October 23, 2008) (notice). The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of certain information related to the record retention requirement of the soy protein/coronary heart disease health claim. View this document.

73 Fed. Reg. 62507 (October 21, 2008) (notice). The Food and Drug Administration is announcing that a collection of information entitled "Premarket Notification for a New Dietary Ingredient" has been approved by the Office of Management and Budget. View this document.

73 Fed. Reg. 61135 (October 15, 2008) (notice; request for information). The Food and Drug Administration is requesting assistance in the identification of types of FDA-regulated products that contain Bisphenol A, whether as a component of the product or its packaging, and information relating to the leaching of BPA. View this document.

73 Fed. Reg. 58871 (October 8, 2008) (final rule) (to be codified at 21 C.F.R. Part 522). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for veterinarian prescription use of ceftiofur crystalline free acid injectable suspension for the treatment of bovine foot rot. View this document.

73 Fed. Reg. 58872 (October 8, 2008) (final rule) (to be codified at 21 C.F.R. Part 522). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for veterinarian prescription use of tulathromycin injectable solution for the treatment of bovine foot rot in beef and non-lactating dairy cattle. View this document.

73 Fed. Reg. 58873 (October 8, 2008) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for use of a fenbendazole free choice, liquid Type C medicated feed in dairy and beef cattle for the removal and control of various internal parasites. View this document.

73 Fed. Reg. 58603 (October 7, 2008) (notice). The Food and Drug Administration is announcing that Anitox has filed a petition proposing that the food additive regulations be amended to provide for the safe use of formaldehyde to retard the growth of Clostridium perfringens in animal feeds. View this document.

73 Fed. Reg. 56477 (September 29, 2008) (final rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is amending its labeling regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis. View this document.

73 Fed. Reg. 55516 (September 25, 2008) (notice). The Food and Drug Administration is announcing that a proposed collection of information related to a health claim or nutrient content claim based on an authoritative statement of a scientific body has been submitted to the Office of Management and Budget. View this document.

73 Fed. Reg. 55115 (September 24, 2008) (notice). The Food and Drug Administration is announcing two public meetings regarding product tracing systems for fresh produce. View this document.

73 Fed. Reg. 54407 (September 19, 2008) (notice). The Food and Drug Administration is announcing the availability of a draft guidance document entitled "Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs." View this document.

73 Fed. Reg. 54106 (September 18, 2008) (proposed rule) (to be codified at 21 C.F.R. Part 1). The Food and Drug Administration is issuing a proposed rule that would require owners or consignees to label imported food that is refused entry into the United States and would describe the label's characteristics and processes for verifying that the label has been affixed properly. View this document.

73 Fed. Reg. 53685 (September 17, 2008) (final rule) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for a revised human food safety warning on labeling for an oral suspension of sulfadiazine and pyrimethamine used for the treatment of equine protozoal myeloencephalitis. View this document.

73 Fed. Reg. 53775 (September 17, 2008) (proposed rule) (to be codified at 29 C.F.R. Parts 125 and 165). The Food and Drug Administration is proposing to amend its bottled water regulations to require that source water be tested specifically for total coliform as is done for finished bottled water products and that if any coliform organisms are detected in source water or finished bottled water products, bottled water manufacturers would be required to test for the bacterium E. coli. FDA also is proposing to amend the adulteration provision of the bottled water standard to reflect the possibility of adulteration caused by the presence of filth. View this document.

73 Fed. Reg. 53254 (September 15, 2008) (notice). The Food and Drug Administration is announcing the rates and payment procedures for fiscal year 2009 for user fees under the Animal Drug User Fee Act program. View this document.

73 Fed. Reg. 53258 (September 15, 2008) (notice). The Food and Drug Administration is announcing the rates and payment procedures for fiscal year 2009 generic new animal drug user fees. View this document.

73 Fed. Reg. 53028 (September 12, 2008) (notice). The Food and Drug Administration is announcing that a collection of information entitled "Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers" has been approved. View this document.

73 Fed. Reg. 51490 (September 3, 2008) (notice). The Food and Drug Administration is announcing the filing of a petition proposing that the food additive regulations be amended to provide for the safe use of monochloramine as an antimicrobial agent in poultry process chiller water. View this document.

73 Fed. Reg. 51306 (September 2, 2008) (notice; request for comments and for scientific data and information). The Food and Drug Administration is requesting comments and scientific data and information that may assist the agency to improve the guidance to industry set forth in the "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables," issued in 1998. View this document.

73 Fed. Reg. 49593 (August 22, 2008) (final rule) (to be codified at 21 C.F.R. Part 179). The Food and Drug Administration is amending the food additive regulations to provide for the safe use of ionizing radiation for control of food-borne pathogens, and extension of shelf-life, in fresh iceberg lettuce and fresh spinach at a dose up to 4.0 kiloGray. View this document.

73 Fed. Reg. 49465 (August 21, 2008) (notice). The Food and Drug Administration is announcing the availability of effectiveness and target animal safety data that may be used in support of a new animal drug application or supplemental NADA for use of chloramine-T by immersion for the control of mortality in freshwater-reared salmonids due to bacterial gill disease. View this document.

73 Fed. Reg. 48127 (August 18, 2008) (extension of comment period; delay of effective date of final rule). The Food and Drug Administration is extending to November 1, 2008, the comment period for the order of prohibition regarding cephalosporin drugs and extralabel animal drug use. View this document.

73 Fed. Reg. 47828 (August 15, 2008) (final rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is adopting as a final rule, without change, the provisions of the interim final rule that amended the regulation authorizing a health claim on soluble fiber from certain foods and risk of coronary heart disease, to add barley betafiber as an additional eligible source of beta-glucan soluble fiber. View this document.

73 Fed. Reg. 47957 (August 15, 2008) (notice). This notice announces a meeting of the Bisphenol A Subcommittee of the Science Board to the Food and Drug Administration. The topic to be discussed is the draft assessment of BPA for use in food contact applications. View this document.

73 Fed. Reg. 46302 (August 8, 2008) (notice). The Food and Drug Administration is announcing a public hearing on the use of advisory labeling of allergens in foods. View this document.

73 Fed. Reg. 45874 (August 7, 2008) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for use of oxytetracycline dihydrate in Type C medicated feeds for the control of mortality in freshwater-reared salmonids due to coldwater disease and for the control of mortality in freshwater-reared Oncorhynchus mykiss due to columnaris disease. View this document.

73 Fed. Reg. 46022 (August 7, 2008) (notice). The Food and Drug Administration is announcing a public meeting and a request for comments including available data to gather information that will assist the agency in further implementing the recommendations of the Nanotechnology Task Force Report relating to the development of agency guidances. View this document.

73 Fed. Reg. 45611 (August 6, 2008) (final rule) (to be codified at 21 C.F.R. Part 522). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a new animal drug application providing for the veterinary prescription use of a ceftiofur hydrochloride injectable suspension for treatment of various bacterial infections in swine and cattle. View this document.

73 Fed. Reg. 45610 (August 6, 2008) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 522). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for label revisions associated with a previous change of sponsorship and other minor changes for amprolium concentrate solution to make medicated drinking water for chickens and turkeys for the treatment of coccidiosis. View this document.

73 Fed. Reg. 45610 (August 6, 2008) (final rule) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for revised scientific nomenclature for an internal parasite for which oxfendazole suspension is used orally in cattle. View this document.

73 Fed. Reg. 45454 (August 5, 2008) (notice). The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes." View this document.

73 Fed. Reg. 45455 (August 5, 2008) (notice). The Food and Drug Administration is announcing the availability of a draft guidance document entitled "Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings." View this document.

73 Fed. Reg. 45456 (August 5, 2008) (notice). The Food and Drug Administration is announcing the availability of a guidance document for FDA advisory committee members and FDA staff entitled "Voting Procedures for Advisory Committee Meetings." View this document.

73 Fed. Reg. 45457 (August 5, 2008) (notice). The Food and Drug Administration is announcing the availability of a document entitled "Guidance for Industry: Advisory Committee Meetings-Preparation and Public Availability of Information Given to Advisory Committee Members," dated August 2008. View this document.

73 Fed. Reg. 45458 (August 5, 2008) (notice). The Food and Drug Administration is announcing the availability of a guidance document for the public, FDA advisory committee members, and FDA staff entitled "Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees" dated August 2008. View this document.

73 Fed. Reg. 45459 (August 5, 2008) (notice). The Food and Drug Administration is announcing the availability of a guidance document for the public, FDA advisory committee members, and FDA staff entitled "Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers." View this document.

73 Fed. Reg. 43937 (July 29, 2008) (notice; request for comments). The Food and Drug Administration is requesting comments regarding the prohibition of the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added or of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public. View this document.

73 Fed. Reg. 42814 (July 23, 2008) (notice). This notice announces the availability of a Sole Source to the Association of Food and Drug Officials to provide funding for a 3-year cooperative agreement award to support a Special Project Cooperative Agreement program intended to have AFDO update and maintain the FDA Directory of State and Local Officials and to update the AFDO document "State Food Safety Resource Survey (2000)" by providing funding for additional personnel, equipment, and supplies to support activities related to these projects. View this document.

73 Fed. Reg. 42816 (July 23, 2008) (notice). This notice announces the availability of cooperative agreements for equipment, supplies, personnel, training, and facility upgrades to Food Emergency Response Laboratory Network chemistry laboratories of State, local, and tribal governments.View this document.

73 Fed. Reg. 41361 (July 18, 2008) (notice). The Food and Drug Administration is announcing the withdrawal of Compliance Policy Guide Sec. 540.575 Fish-Fresh and Frozen-Adulteration Involving Decomposition (CPG 7108.05) (CPG Sec. 540.575) because the guidance in CPG Sec. 540.575 relating to decomposition in fresh and frozen fish is not current.View this document.

73 Fed. Reg. 41361 (July 18, 2008) (notice). The Food and Drug Administration is announcing the availability of draft Compliance Policy Guide Sec. 540.370 Fish and Fishery Products-Decomposition which, when final, will provide FDA staff with current regulatory action guidance relating to decomposition in fish and fishery products.View this document.

73 Fed. Reg. 41363 (July 18, 2008) (notice). The Food and Drug Administration is announcing the availability of a small entity compliance guide entitled "Food Labeling; Nutrient Content Claims; Definition for 'High Potency' and Definition of 'Antioxidant' for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods."View this document.

73 Fed. Reg. 41090 (July 17, 2008) (notice). The Food and Drug Administration is announcing the availability of a small entity compliance guide entitled "Standard of Identity for White Chocolate."View this document.

73 Fed. Reg. 41089 (July 17, 2008) (notice). The Food and Drug Administration is announcing the availability of a small entity compliance guide entitled "Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk." View this document.

73 Fed. Reg. 39972 (July 11, 2008) (notice). The Food and Drug Administration is requesting nominations for voting members to serve on the Food Advisory Committee, Center for Food Safety and Applied Nutrition. View this document.

73 Fed. Reg. 39704 (July 10, 2008) (notice). The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Voluntary Third-Party Certification Programs for Foods and Feeds." View this document.

73 Fed. Reg. 39705 (July 10, 2008) (notice). The Food and Drug Administration is seeking third-party certification bodies that certify foreign processors of aquacultured shrimp for compliance with FDA's Seafood Hazard Analysis and Critical Control Point regulations to volunteer to participate in a pilot program to be conducted by FDA's Center for Food Safety and Applied Nutrition and Office of Regulatory Affairs. View this document.

73 Fed. Reg. 39316 (July 9, 2008) (notice). This notice announces the availability of cooperative agreements funding to further enhance the infrastructure of State, territorial, and tribal animal feed safety and bovine spongiform encephalopathy prevention programs. View this document.

73 Fed. Reg. 38110 (July 3, 2008) (final rule) (to be codified at 21 C.F.R. Part 530). The Food and Drug Administration is issuing an order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals. View this document.

73 Fed. Reg. 37974 (July 2, 2008) (notice; correction). The Food and Drug Administration is correcting a document announcing the withdrawal, without prejudice to a future filing, of a food additive petition that appeared in the Federal Register of June 20, 2008. View this document.

73 Fed. Reg. 37466 (July 1, 2008) (notice). The Food and Drug Administration is announcing the availability of grant funds for the support of innovative food defense projects. View this document.

73 Fed. Reg. 36875 (June 30, 2008) (notice). The Food and Drug Administration is announcing a Request for Application Number RFA-FD-08-004 and its intention to receive and consider a new sole source application for the award of a cooperative agreement in fiscal year 2008 to establish and support the Western Center for Food Safety. View this document.

73 Fed. Reg. 36878 (June 30, 2008) (notice). The Food and Drug Administration is announcing the availability of an Agreement of Limited Competition. States with current FDA Food Safety contracts to provide funding to State agency food protection regulatory programs are eligible for a 3-year cooperative agreement to develop and sustain an all Food Hazards Rapid Response Team. View this document.

73 Fed. Reg. 36090 (June 25, 2008) (notice). The Food and Drug Administration is announcing the availability of a guidance for industry entitled "Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions." View this document.

73 Fed. Reg. 35579 (June 24, 2008) (final rule) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for a revised food safety warning statement for oral use of sulfachlorpyridazine in the milk or milk replacer of ruminating calves. View this document.

73 Fed. Reg. 35142 (June 20, 2008) (notice). The Food and Drug Administration is announcing the withdrawal, without prejudice to a future filing, of a food additive petition proposing that the food additive regulations be amended to provide for the safe use of alitame as a sweetening agent or flavoring in food. View this document.

73 Fed. Reg. 34184 (June 17, 2008) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for revision of an effectiveness claim and pathogen nomenclature for a tylosin phosphate and sulfamethazine Type A medicated article used to manufacture medicated swine feeds. View this document.

73 Fed. Reg. 34184 (June 17, 2008) (final rule) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application which adds effectiveness claims against various species of internal parasites when horses are treated with ivermectin paste. View this document.

73 Fed. Reg. 33027 (June 11, 2008) (notice of public hearing; reopening of comment period). The Food and Drug Administration is reopening until August 11, 2008, the comment period for the notice of public hearing requesting comments regarding FDA's current framework of policies regarding salt and sodium and potential future approaches, including approaches described in a citizen petition. View this document.

73 Fed. Reg. 32715 (June 10, 2008) (notice). The Food and Drug Administration is announcing the availability of conference grant funding for meetings of State Food Protection Task Forces. View this document.

73 Fed. Reg. 32338 (June 6, 2008) (notice; withdrawal). The Food and Drug Administration is announcing the withdrawal of Compliance Policy Guide Sec. 560.700 Processing of Imported Frozen Products of Multiple Sizes (e.g., Shrimp, Prawns, Etc.) (CPG 7119.10) (CPG Sec. 560.700). View this document.

73 Fed. Reg. 31698 (June 3, 2008) (notice). The Food and Drug Administration, Office of Regulatory Affairs, Southwest Regional Small Business Representative Program, in collaboration with The University of Arkansas, is announcing a public workshop entitled "Food Labeling Workshop" on August 12-13, 2008. View this document.

73 Fed. Reg. 31357 (June 2, 2008) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 522). The Food and Drug Administration is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application providing for the veterinary prescription use of butorphanol tartrate injectable solution in horses for the relief of pain. View this document.

73 Fed. Reg. 31490 (June 2, 2008) (notice). The Food and Drug Administration is announcing the availability of approximately $1.0 million in research funds for fiscal year 2008 to be used to support research efforts to advance the safe transportation and preparation of produce and to help reduce the incidence of foodborne illness that may be associated with fresh produce consumption. View this document.

73 Fed. Reg. 30299 (May 27, 2008) (final rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is adopting as a final rule, without change, the provisions of the interim final rule that amended the regulation authorizing a health claim on noncariogenic carbohydrate sweeteners and dental caries to include isomaltulose as a substance eligible for the health claim. View this document.

73 Fed. Reg. 30405 (May 27, 2008) (notice). The Food and Drug Administration is announcing a delay in the implementation of the Reportable Food Registry of the Food and Drug Administration Amendments Act of 2007. FDA is also requesting comments on certain aspects of the Registry provisions. View this document.

73 Fed. Reg. 29520 (May 21, 2008) (notice). The FDA is announcing that Lubrizol Advanced Materials, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of cassia gum as a stabilizer in frozen dairy desserts, and to improve texture and water retention in cheeses, meat products, and poultry products. View this document.

73 Fed. Reg. 28036 (May 15, 2008) (final rule) (to be codified at 21 C.F.R. Part 522). The FDA is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application providing for the veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for control of pyrexia associated with acute bovine mastitis. View this document.

73 Fed. Reg. 27727 (May 14, 2008) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 111). The FDA is correcting a final rule that appeared in the Federal Register of June 25, 2007 establishing current good manufacturing practice requirements in manufacturing, packaging, labeling, or holding operations for dietary supplements. View this document.

73 Fed. Reg. 23947 (May 1, 2008) (final rule) (to be codified at 21 C.F.R. Part 101). The FDA is amending its regulation authorizing a health claim on the relationship between soluble fiber from certain foods and risk of coronary heart disease to exempt certain foods from the nutrient content requirement of "low fat." View this document.

73 Fed. Reg. 23066 (April 29, 2008) (final rule) (to be codified at 21 C.F.R. Part 510). The FDA is amending the animal drug regulations to reflect a change of the sponsor's name. View this document.

73 Fed. Reg. 22719 (April 25, 2008) (final rule) (to be codified at 21 C.F.R. Part 589). The FDA is amending the agency's regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals. These measures will further strengthen existing safeguards against BSE. View this document.

73 Fed. Reg. 22715 (April 25, 2008) (notice). EPA is making available a final White Paper that reviews data on the level in the human food supply of Cry9C protein from StarLink corn grain. The White Paper recommends that the FDA withdraw its guidance recommending testing yellow corn grain for Cry9C at dry mills and masa production facilities. Concurrent with this notice, FDA is publishing a notice withdrawing its guidance. View this document.

73 Fed. Reg. 22716 (April 25, 2008) (notice; withdrawal). The FDA is announcing the withdrawal of a guidance document entitled "FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues" in response to the release by the EPA of its final "White Paper Concerning Dietary Exposure to Cry9C Protein Produced by STARLINK Corn and the Potential Risks Associated With Such Exposure." View this document.

73 Fed. Reg. 21819 (April 23, 2008) (final rule; technical amendment) (to be codified at 21 C.F.R. Parts 522 and 556). The FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for use of enrofloxacin injectable solution in swine for the treatment and control of respiratory disease. View this document.

73 Fed. Reg. 21355 (April 21, 2008) (notice). The FDA is announcing the "Meeting to Present Changes to the Animal Feed Safety System Project and the Ranking of Feed Hazards According to the Risks They Pose to Animal and Public Health; Part 3: Swine Feed Example." View this document.

73 Fed. Reg. 21357 (April 21, 2008) (notice). The FDA is announcing a public meeting to obtain input from stakeholder groups concerning the development of ingredient standards and definitions, processing standards, and labeling standards for pet food. View this document.

73 Fed. Reg. 21041 (April 18, 2008) (final rule) (to be codified at 21 C.F.R. Part 522). The FDA is amending the animal drug regulations to reflect approval of a new animal drug application providing for use of florfenicol injectable solution for the treatment of bovine respiratory disease. View this document.

73 Fed. Reg. 20785 (April 17, 2008) (interim final rule; request for comments) (to be codified at 21 C.F.R. Parts 189 and 700). The FDA has designated certain materials from cattle as "prohibited cattle materials" and has banned the use of such materials in human food, including dietary supplements, and in cosmetics. FDA is amending its regulations so that FDA may designate a country as not subject to certain bovine spongiform encephalopathy-related restrictions. View this document.

73 Fed. Reg. 20309 (April 15, 2008) (notice). The FDA is announcing a public hearing on antimicrobial resistance. FDA is seeking general information about the problem of antimicrobial resistance, recommendations as to possible approaches to contain the problem of antimicrobial resistance, responses to specific questions, and other pertinent information from interested parties. View this document.

73 Fed. Reg. 19432 (April 10, 2008) (final rule) (to be codified at 21 C.F.R. Part 588). The FDA is amending the animal drug regulations to reflect approval of a new animal drug application providing for use of approved, single-ingredient Type A medicated articles containing zilpaterol hydrochloride, monensin USP, and melengestrol acetate in three-way combination Type B and Type C medicated feeds for heifers fed in confinement for slaughter. View this document.

73 Fed. Reg. 19513 (April 1, 2008) (notice). The FDA is announcing the availability of a guidance for industry (181) entitled "Blue Bird Medicated Feed Labels." This guidance provides new animal drug application sponsors with the Center for Veterinary Medicine's current thinking on what constitutes recommended content and format of representative labels for new animal drugs intended for use in the manufacture of medicated feeds. View this document.

73 Fed. Reg. 18958 (April 8, 2008) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 558). The FDA is amending the animal drug regulations to reflect approval of a new animal drug application providing for use of approved, single-ingredient Type A medicated articles containing zilpaterol hydrochloride, monensin USP, tylosin phosphate, and melengestrol acetate in four-way combination Type B and Type C medicated feeds for heifers fed in confinement for slaughter. View this document.

73 Fed. Reg. 18441 (April 4, 2008) (final rule; technical amendment) (to be codified at 21 C.F.R. Parts 510, 520, 526, and 558). The FDA is amending the animal drug regulations by removing those portions that reflect approval of seven new animal drug applications because FDA is withdrawing approval of the NADAs. View this document.

73 Fed. Reg.17890 (April 2, 2008) (final rule) (to be codified at 21 C.F.R. Part 522). The FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for the use of enrofloxacin injectable solution in female dairy cattle less than 20 months of age. View this document.

73 Fed. Reg.17987 (April 2, 2008) (notice). The FDA is announcing that it is establishing a public docket to receive information and comments related to its comprehensive Food Protection Plan released in November 2007. The new Plan presents a robust strategy to protect the nation's food supply from both unintentional contamination and deliberate attack. View this document.

73 Fed. Reg. 17989 (April 2, 2008) (notice). The Food FDA is requesting comments on the use of third-party certification programs for foods and feeds, including pet foods. View this document.

73 Fed. Reg. 16754 (March 31, 2008) (final rule) (to be codified at 21 C.F.R. Part 522). The FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for changing scientific nomenclature for a bovine pathogen on labeling for penicillin G benzathine and penicillin G procaine injectable suspension. View this document.

73 Fed. Reg. 16754 (March 31, 2008) (final rule) (to be codified at 21 C.F.R. Part 558). The FDA is amending the animal drug regulations to reflect approval of a new animal drug providing for use of approved, single-ingredient Type A medicated articles containing zilpaterol hydrochloride and melengestrol acetate in two-way combination Type B and Type C medicated feeds for heifers fed in confinement for slaughter. View this document.

73 Fed. Reg. 16861 (March 31, 2008) (notice). The FDA is announcing the availability of compliance policy guide Sec. 500.500 Guidance Levels for 3-MCPD (3-chloro-1, 2-propanediol) in Acid-Hydrolyzed Protein and Asian-Style Sauces. The CPG provides regulatory action guidance for FDA staff regarding 3-MCPD in acid-hydrolyzed protein and Asian-style sauces. View this document.

73 Fed. Reg. 15884 (March 26, 2008) (final rule) (to be codified at 21 C.F.R. Part 558). The FDA is amending the animal drug regulations to reflect approval of a new animal drug application providing for use of approved, single-ingredient Type A medicated articles containing bacitracin methylene disalicylate and nicarbazin to formulate two-way combination drug Type C medicated feeds for broiler chickens. View this document.

73 Fed. Reg. 16024 (March 26, 2008) (notice; correction). The FDA is correcting a notice that announced that a temporary permit has been issued to Florida's Natural Growers to market test a product. The document was published with an incorrect value for the Brix (measure of concentration of sugars in juice). View this document.

73 Fed. Reg. 15661 (March 25, 2008) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 558). The FDA is amending its animal drug regulations to correct an inadvertent omission in the list of concentrations of pyrantel tartrate Type A medicated articles approved for use by Phibro Animal Health. View this document.

73 Fed. Reg. 14926 (March 20, 2008) (final rule) (to be codified at 21 C.F.R. Part 522). The FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for changing scientific nomenclature for a bovine pathogen on labeling for 300 milligrams per milliliter strength oxytetracycline injectable solution. View this document.

73 Fed. Reg. 14384 (March 18, 2008) (final rule; technical amendment) (to be codified at 21 C.F.R. Parts 510 and 522). The FDA is amending the animal drug regulations to reflect a change of sponsor's name from Animal Health Pharmaceuticals, LLC, to Pharmacosmos, Inc. View this document.

73 Fed. Reg. 14385 (March 18, 2008) (final rule) (to be codified at 21 C.F.R. Part 588). The FDA is amending the animal drug regulations to reflect approval of a new animal drug application providing for use of approved, single-ingredient zilpaterol hydrochloride and monensin U.S.P. Type A medicated articles to make two-way combination Type B and Type C medicated feeds for cattle fed in confinement for slaughter. View this document.

73 Fed. Reg. 14177 (March 17, 2008) (final rule) (to be codified at 21 C.F.R. Part 522). The FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for changing scientific nomenclature for a swine pathogen on labeling for penicillin G procaine aqueous suspension. View this document.

73 Fed. Reg. 13123 (March 12, 2008) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 111). The FDA is correcting a final rule that appeared in the Federal Register of June 25, 2007 which established current good manufacturing practice requirements for dietary supplements. This document corrects an inadvertent error in the codified section. View this document.

73 Fed. Reg. 12634 (March 10, 2008) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 522). The FDA is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications for injectable iron supplements used in baby pigs. FDA is also consolidating injectable iron supplements in a single section of the Code of Federal Regulations. View this document.

73 Fed. Reg. 12262 (March 7, 2008) (final rule) (to be codified at 21 C.F.R. Part 526). The FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for a revision to the labeling of cephapirin benzathine intramammary infusion administered to dairy cows entering their dry period for the treatment of mastitis. View this document.

73 Fed. Reg. 12180 (March 6, 2008) (notice). The FDA is announcing that a temporary permit has been issued to Yardarm Knot Fisheries, LLC, to market test canned Pacific salmon that deviates from the U.S. standard of identity for canned Pacific salmon, to allow the applicant to measure consumer acceptance of the product and assess commercial feasibility. View this document.

73 Fed. Reg. 11026 (February 29, 2008) (final rule) (to be codified at 21 C.F.R. Parts 520 and 556). The FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for use of albendazole oral suspension in nonlactating goats for the treatment of liver flukes. View this document.

73 Fed. Reg. 11095 (February 29, 2008) (notice). The FDA is announcing that a temporary permit has been issued to Florida's Natural Growers, to market test a product designated as "Frozen Concentrate for Lemonade 3+1 Ratio" that deviates from the U.S. standard of identity for frozen concentrate for lemonade. View this document.

73 Fed. Reg. 9938 (February 25, 2008) (interim final rule) (to be codified at 21 C.F.R. Part 101). The FDA is amending the health claim regulation entitled "Soluble fiber from certain foods and risk of coronary heart disease" to add barley betafiber as an additional eligible source of beta-glucan soluble fiber. View this document.

73 Fed. Reg. 10037 (February 25, 2008) (notice). The FDA is announcing the availability of a final guidance document entitled "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables." View this document.

73 Fed. Reg. 9455 (February 21, 2008) (final rule) (to be codified at 21 C.F.R. Part 520). The FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for revised food safety labeling for altrenogest oral solution used in horses. View this document.

73 Fed. Reg. 9455 (February 21, 2008) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 520). The FDA is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application providing for revised labeling for ivermectin oral liquid used in horses. View this document.

73 Fed. Reg. 9571 (February 21, 2008) (notice). The FDA is publishing proposed recommendations for the reauthorization of the Animal Drug User Fee Act of 2003 for fiscal years 2009 to 2013. A public meeting will be held on March 11, 2008, from 1 p.m. to 3:30 p.m. View this document.

73 Fed. Reg. 8606 (February 14, 2008) (final rule; technical amendments) (to be codified at 21 C.F.R. Part 184). The FDA is amending certain regulations regarding generally recognized as safe substances to remove references to FDA development of food-grade specifications in cooperation with the National Academy of Sciences. View this document.

73 Fed. Reg. 8191 (February 13, 2008) (final rule) (to be codified at 21 C.F.R. Parts 510 and 522). The FDA is amending the animal drug regulations to reflect a change of sponsor for an abbreviated new animal drug application for ketamine hydrochloride injectable solution from Veterinary Research Associates, Inc., to Putney, Inc. View this document.

73 Fed. Reg. 8192 (February 13, 2008) (final rule) (to be codified at 21 C.F.R. Part 520). The FDA is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications providing revised labeling for phenylbutazone tablets used in horses and dogs. View this document.

73 Fed. Reg. 7692 (February 11, 2008) (proposed rule) (to be codified at 21 C.F.R. Part 133). The FDA is extending the comment period until April 11, 2008, for a proposed rule that was published in the Federal Register of October 19, 2005 to seek further comment on only two specific issues raised by the comments concerning the proposed ingredient declaration. View this document.

73 Fed. Reg. 7293 (February 7, 2008) (notice). The FDA is announcing the availability of the draft Compliance Policy Guide Sec. 555.320 Listeria monocytogenes, providing guidance for FDA staff on the agency's enforcement policy for Listeria monocytogenes in ready-to-eat foods. View this document.

73 Fed. Reg. 7293 (February 7, 2008) (notice). The Food FDA is announcing the availability of the draft guidance entitled "Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods," which will complement FDA's current good manufacturing practices regulations by providing specific guidance on the control of L. monocytogenes in the processing of refrigerated or frozen ready-to-eat foods. View this document.

73 Fed. Reg. 7298 (February 7, 2008) (notice). The FDA is announcing a public meeting to discuss a Draft Compliance Policy Guide Sec. 555.320 Listeria monocytogenes that provides guidance for FDA staff on the agency's enforcement policy for L. monocytogenes in ready-to-eat foods. View this document.

73 Fed. Reg. 6973 (February 6, 2007) (notice). The FDA is announcing the availability of a guidance document entitled "Fish and Fisheries Products Hazards and Controls Guidance, Third Edition June 2001: Letter to Seafood Processors that Purchase Grouper, Amberjack and Related Predatory Reef Species Captured in the Northern Gulf of Mexico." View this document.

73 Fed. Reg. 6607 (February 5, 2008) (final rule) (to be codified at 21 C.F.R. Part 520). The FDA is amending the animal drug regulations to correct an error in the indications for use for spectinomycin oral solution in swine and is amending the regulations for other oral dosage forms of spectinomycin to reflect a current format. View this document.

73 Fed. Reg. 6017 (February 1, 2008) (final rule) (to be codified at 21 C.F.R. Part 522). The FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing veterinarian prescription use of tulathromycin injectable solution for the treatment of infectious bovine keratoconjunctivitis and the addition of a pathogen to the indication for use for treatment of swine respiratory disease. View this document.

73 Fed. Reg. 6018 (February 1, 2008) (final rule) (to be codified at 21 C.F.R. Part 558). The FDA is amending the animal drug regulations to reflect approval of a new animal drug application providing for use of zilpaterol, monensin, and tylosin in three-way combination Type B and Type C medicated feeds for cattle fed in confinement for slaughter. View this document.

73 Fed. Reg. 4765 (January 28, 2008) (advance notice of proposed rulemaking; extension of comment period) (to be codified at 21 C.F.R. Part 101). The notice and comment period for the advance notice of proposed rulemaking that appeared in the Federal Register of November 2, 2007, is extended to April 30, 2008. It requested comments on what new reference values the agency should use to calculate the percent daily value in the Nutrition Facts and Supplement Facts labels, what factors the agency should consider in establishing such new reference values, and whether it should require that certain nutrients be added or removed from the Nutrition Facts and Supplement Facts labels. View this document.

73 Fed. Reg. 3181 (January 17, 2008) (final rule) (to be codified at 21 C.F.R. Part 526). The FDA is amending the animal drug regulations to reflect approval of supplemental new animal drug applications, providing for revisions to the labeling of two cephapirin sodium products administered by intramammary infusion to lactating cows for the treatment of mastitis.    View this document.

73 Fed. Reg. 2808 (January 16, 2008) (final rule) (to be codified at 21 C.F.R. Part 522). The FDA is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application, providing for the veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for control of pyrexia associated with acute bovine mastitis. View this document.

73 Fed. Reg. 2923 (January 16, 2008) (notice). The FDA is announcing the availability of a risk assessment on animal cloning, which evaluates the health risks to animals and the food consumption risks that may result from edible products derived from animal clones or their progeny. A risk management plan for animal clones and their progeny is also available. In addition, FDA is announcing availability of guidance for industry 179, describing recommendations regarding the use of edible products from animal clones and their progeny in human food or in animal feed. View this document.

73 Fed. Reg. 2264 (January 14, 2008) (notice). The FDA is providing notice that effective January 15, 2008, the public will no longer be able to submit electronic comments to its Dockets through FDA's Web site. Electronic comments to FDA's Dockets may continue to be submitted through the Federal eRulemaking Portal. View this document.

73 Fed. Reg. 2055 (January 11, 2008) (notice). The FDA is announcing that Kemira Oyi has filed a petition proposing that the food additive regulations be amended to provide for the safe use of partially ammoniated formic acid as a pH control agent in swine feed. View this document.

73 Fed. Reg. 1619 (January 9, 2008) (notice). The FDA is providing notice of a memorandum of understanding between FDA and the University of California, Davis. It establishes terms of collaboration between FDA and UC Davis, focused primarily but not exclusively, in the areas of the safety and security of foods and cosmetics, animal feeds and veterinary products. It will also include UC Davis extended partnerships such as the Western Institute for Food Safety and Security, and the Center for Produce Safety. View this document.

73 Fed. Reg. 1357 (January 8, 2008) (notice). The Food and Drug Administration is announcing the withdrawal of Compliance Policy Guide Sec. 555.700 Revocation of Tolerances for Cancelled Pesticides (CPG 7120.29) (CPG Sec. 555.700). View this document.

73 Fed. Reg. 1357 (January 8, 2008) (notice). The Food and Drug Administration is announcing the availability of draft, revised Compliance Policy Guide (CPG) Sec. 575.100 Pesticide Chemical Residues in Food--Enforcement Criteria (CPG 7141.01), intended to provide guidance to FDA staff on FDA's internal enforcement processes concerning pesticide chemical residues in food. View this document.

73 Fed. Reg. 1225 (January 7, 2008) (notice). The FDA is announcing its intention to schedule and hold a public meeting early in 2008 to obtain input from stakeholder groups, including, but not limited to, the Association of American Feed Control Officials, veterinary medical associations, animal health organizations, and pet food manufacturers for the development of ingredient, processing, and labeling standards to ensure the safety of pet food. View this document.

73 Fed. Reg. 811 (January 4, 2008) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a new animal drug application filed by Phibro Animal Health, providing for use of a Type A medicated article containing semduramicin to manufacture Type C medicated broiler chicken feed for the prevention of coccidiosis. View this document.

73 Fed. Reg. 191 (January 2, 2008) (notice). Part D, Food and Drug Administration, Chapter DB, Office of Operations, Center for Food Safety and Applied Nutrition, of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services is amended to reflect the restructuring of the Center for Food Safety and Applied Nutrition, Office of Operations, Food and Drug Administration. View this document.

73 Fed. Reg. 197 (January 2, 2008) (notice). The Food and Drug Administration is announcing the availability of a draft guidance entitled "Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act." View this document.

72 Fed. Reg. 72920 (December 26, 2007) (final rule) (to be codified at 21 C.F.R. Part 510). The Food and Drug Administration is amending the animal drug regulations to reflect a change of sponsor's name from Altana, Inc., to Nycomed US, Inc. View this document.

72 Fed. Reg. 73028 (December 26, 2007) (notice; correction). The Food and Drug Administration is correcting a notice that appeared in the Federal Register of December 4, 2007, announcing the filing of a petition proposing that the color additive regulations be amended to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive in the feed of salmonid fish to enhance the color of their flesh. View this document.

72 Fed. Reg. 72738 (December 21, 2007) (notice). The Food and Drug Administration is announcing an opportunity for public comment on its intent to reevaluate the scientific evidence for two previously authorized health claims (dietary lipids (fat) and cancer; soy protein and risk of coronary heart disease) and two qualified health claims that were the subject of letters of enforcement discretion (antioxidant vitamins and risk of certain cancers; selenium and certain cancers). View this document.

72 Fed. Reg. 70774 (December 13, 2007) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for a zero-day preslaughter withdrawal time following use of oxytetracycline in turkey and swine feed. View this document.

72 Fed. Reg. 70776 (December 13, 2007) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for an increased level of monensin in three-way combination Type C medicated feeds containing ractopamine, melengestrol, and monensin for heifers fed in confinement for slaughter. View this document.

72 Fed. Reg. 70251 (December 11, 2007) (proposed rule; reopening of comment period) (to be codified at 21 C.F.R. Part 133). The Food and Drug Administration is reopening until February 11, 2008, the comment period for the proposed rule published in the Federal Register of October 19, 2005, which proposed to amend the regulations to provide for the use of fluid ultrafiltered milk in the manufacture of standardized cheeses and related cheese products. The FDA is seeking further comment only on two specific issues concerning the proposed ingredient declaration. View this document.

72 Fed. Reg. 69142 (December 7, 2007) (final rule) (to be codified at 21 C.F.R. Part 522). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application filed by Cross Vetpharm Group Ltd., providing for use of a 100 mg/mL strength erythromycin injectable solution in cattle for the treatment of bovine respiratory disease. View this document.

72 Fed. Reg. 69107 (December 6, 2007) (final rule) (to be codified at 21 C.F.R. Parts 20, 25, 201, et al.). The FDA is issuing final regulations to implement section 572 of the Federal Food, Drug, and Cosmetic Act entitled "Index of Legally Marketed Unapproved New Animal Drugs for Minor Species" which establish administrative procedures and criteria for index listing a new animal drug for use in a minor species, providing a basis for legally marketing an unapproved new animal drug intended for use in a minor species. View this document.

72 Fed. Reg. 68477 (December 5, 2007) (final rule) (to be codified at 21 C.F.R. Parts 510 and 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application filed by Belcher Pharmaceuticals, Inc., providing for veterinary prescription use of carprofen caplets in dogs. View this document.

72 Fed. Reg. 68478 (December 5, 2007) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application filed by Elanco Animal Health, revising the concentration of monensin in two-way Type B and Type C medicated feeds containing monensin and tylosin to cattle fed in confinement for slaughter and a revision to bacterial pathogen nomenclature. View this document.

72 Fed. Reg. 68479 (December 5, 2007) (final rule; technical amendment) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application filed by Elanco Animal Health, removing the requirement for 30-day expiration on labeling of monensin Type C medicated feeds for several classes of cattle and goats. View this document.

72 Fed. Reg. 68166 (December 4, 2007) (notice). The Food and Drug Administration is announcing that DSM Nutritional Products, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive in the feed of salmonid fish to enhance the color of their flesh. View this document.

72 Fed. Reg. 67943 (December 3, 2007) (notice). The Food and Drug Administration is announcing that General Mills, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of ultraviolet radiation for the reduction of pathogens and other microorganisms in aqueous sugar solutions and potable water intended for use in food production. View this document.

72 Fed. Reg. 67735 (November 30, 2007) (notice). The Food and Drug Administration is reopening to January 15, 2008, the comment period for the notice of public hearing published in the Federal Register of July 20, 2007, which requested comments on the use of symbols to communicate nutrition information on food labels. View this document.

72 Fed. Reg. 67572 (November 29, 2007) (final rule) (to be codified at 29 C.F.R. Part 173). The Food and Drug Administration is amending the food additive regulations to expand the conditions for the safe use of cetylpyridinium chloride as an antimicrobial agent in a pre-chiller or post-chiller solution for application to raw poultry carcasses in response to a petition filed by Safe Foods Corp. View this document.

72 Fed. Reg. 67310 (November 28, 2007) (notice). The Food and Drug Administration is requesting comments and scientific data and information that would assist the agency in its plans to conduct a risk assessment for Listeria monocytogenes in soft-ripened cheese. View this document.

72 Fed. Reg. 66045 (November 27, 2007) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application filed by Intervet Inc., providing for a revised food safety warning on labeling for fenbendazole Type A medicated article and Type B and Type C medicated horse feeds. View this document.

72 Fed. Reg. 66103 (November 27, 2007) (proposed rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration proposes to issue this rule, in response to three notifications that were filed, finding that certain nutrient content claims for foods that contain omega-3 fatty acids do not meet the requirements of the Federal Food, Drug, and Cosmetic Act and may not appear in food labeling. FDA has reviewed the information included in three notifications and is proposing to prohibit the nutrient content claims for DHA and EPA set forth in them because they are not based on an authoritative statement that identifies a nutrient level to which the claims refer, and to prohibit the nutrient content claims for ALA because they are based on a daily value that was determined by a different method than daily values already established for other nutrients. View this document.

72 Fed. Reg. 65885 (November 26, 2007) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect the approval of a supplemental new animal drug application providing for the use of florfenicol by veterinary feed directive for the control of mortality in freshwater-reared salmonids due to furunculosis associated with Aeromonas salmonicida. View this document.

72 Fed. Reg. 65666 (November 23, 2007) (final rule) (to be codified 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application, providing for an increased level of monensin in two-way combination Type B and Type C medicated feeds containing ractopamine hydrochloride and monensin for cattle fed in confinement for slaughter. View this document.

72 Fed. Reg. 65751 (November 23, 2007) (notice). The Food and Drug Administration is announcing the availability of a revised guidance for industry entitled "Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)." View this document.

72 Fed. Reg. 65752 (November 23, 2007) (notice). The Food and Drug Administration is announcing the availability of a revised guidance for industry entitled "Impurities in New Veterinary Medicinal Products (Revision)." View this document.

72 Fed. Reg. 65753 (November 23, 2007) (notice). The Food and Drug Administration is announcing the availability of a revised guidance for industry entitled "Impurities in New Veterinary Drug Substances (Revision)." View this document.

72 Fed. Reg. 65042 (November 19, 2007) (notice). This notice announces the withdrawal, without prejudice to a future filing, of a food additive petition proposing an amendment to provide for the safe use of poly (iminoimidocarbonyliminoimidocarbonyliminohexamethylene) hydrochloride as an antimicrobial agent for food-contact paper and paperboard. View this document.

72 Fed. Reg. 65042 (November 19, 2007) (notice). The Food and Drug Administration is providing notice of a memorandum of understanding between FDA and the Association of American Feed Control Officials. It clarifies the responsibilities of FDA and AAFCO in defining feed ingredients, providing mechanisms for resolving disputes that may arise, and providing mechanisms for modifying the ingredient definition process when required. View this document.

72 Fed. Reg. 63986 (November 14, 2007) (final rule) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application providing for label revisions for chlortetracycline soluble powder. View this document.

72 Fed. Reg. 63986 (November 14, 2007) (final rule) (to be codified at 21 C.F.R. Part 510). The Food and Drug Administration is amending the animal drug regulations to reflect a change of sponsor address for IDEXX Pharmaceuticals, Inc. View this document.

72 Fed. Reg. 62771 (November 7, 2007) (final rule) (to be codified at 21 C.F.R. Part 522). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application which adds claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a one percent ivermectin solution by subcutaneous injection. View this document.

72 Fed. Reg. 62570 (November 6, 2007) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application filed by Elanco Animal Health that provides for an increased level of monensin in three-way combination Type C medicated feeds containing ractopamine, monensin, and tylosin for cattle fed in confinement for slaughter and a revision to bacterial pathogen nomenclature. View this document.

72 Fed. Reg. 62149 (November 2, 2007) (advanced notice of proposed rulemaking) (to be codified at 21 C.F.R. Part 101). The agency requests comment on new reference values and factors to consider regarding Nutrition Facts and Supplement Facts labels, as well as whether it should require that certain nutrients be added or removed from the labels. View this document.

72 Fed. Reg. 61357 (October 30, 2007) (notice). This notice announces that a petition has been filed proposing that the food additive regulations be amended to provide for the safe use of Eubacterium bacterial species in feed for detoxifying trichothecene mycotoxins in the digestive tracts of swine and poultry. View this document.

72 Fed. Reg. 61358 (October 30, 2007) (notice). The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Acute Bacterial Sinusitis: Developing Drugs for Treatment." View this document.

72 Fed. Reg. 60550 (October 25, 2007) (final rule) (to be codified at 21 C.F.R. Part 520). The agency is amending the animal drug regulations to reflect approval of a supplemental new animal drug application filed by Luitpold Pharmaceuticals, Inc., which provides for a revised human food safety warning for phenylbutazone paste, used in horses for relief of inflammatory conditions associated with the musculoskeletal system. View this document.

72 Fed. Reg. 60550 (October 25, 2007) (final rule) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a new animal drug application filed by Elanco Animal Health, which provides for veterinary prescription use of spinosad chewable tablets to kill fleas and for the prevention and treatment of flea infestations on dogs for 1 month. View this document.

72 Fed. Reg. 59973 (October 23, 2007) (proposed rule and notice of public hearing) (to be codified at 21 C.F.R. Part 15). The agency is announcing a public hearing concerning FDA's policies regarding salt and sodium in food. FDA also is announcing the availability for comment of a citizen petition requesting that FDA make changes to the regulatory status of salt, require limits on salt in processed foods, and require health messages related to salt and sodium. View this document.

72 Fed. Reg. 58980 (October 17, 2007) (notice). The agency is seeking comment on whether to withdraw its guidance document entitled "FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues" in response to the release by the Environmental Protection Agency of a draft "White Paper Concerning Dietary Exposure to Cry9C Protein Produced by STARLINK Corn and the Potential Risks Associated with Such Exposure." View this document.

72 Fed. Reg. 58313 (October 15, 2007) (notice). The agency is announcing the availability of a draft guidance entitled "Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act." View this document.

72 Fed. Reg. 57199 (October 9, 2007) (final rule) (to be codified at 21 C.F.R. Parts 516 and 556). The agency is amending the animal drug regulations to reflect conditional approval of an application for a new animal drug, florfenicol. View this document.

72 Fed. Reg. 56896 (October 5, 2007) (final rule) (to be codified at 221 C.F.R. Parts 556 and 558). The agency is amending the animal drug regulations to reflect approval of a supplemental new animal drug application that provides for an increased level of monensin in four-way combination Type C medicated feeds containing ractopamine, melengestrol, monensin and tylosin for heifers fed in confinement for slaughter; a revision to bacterial pathogen nomenclature; and an increase in liver tolerance. View this document.

72 Fed. Reg. 56896 (October 5, 2007) (final rule) (to be codified at 221 C.F.R. Part 522). The agency is amending the animal drug regulations to reflect approval of a supplemental new animal drug application that provides for a revised food safety warning on labeling for an injectable solution of polysulfated glycosaminoglycan used in horses. View this document.

72 Fed. Reg. 56079 (October 2, 2007) (notice). The agency is announcing the availability of a guidance for industry entitled "Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims." View this document.

72 Fed. Reg. 54539 (September 26, 2007) (final rule) (to be codified at 21 C.F.R. Part 522). The agency is amending the animal drug regulations to reflect approval of a supplemental new animal drug that provides for the addition of a pathogen to the indication for use of tulathromycin, by injection, for the control of respiratory disease in high-risk cattle. View this document.

72 Fed. Reg. 54446 (September 25, 2007) (notice). The Food and Drug Administration is announcing the availability of the draft guidance document entitled "Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions." View this document.

72 Fed. Reg. 52783 (September 17, 2007) (final rule) (to be codified at 21 C.F.R. Part 101). The agency amends the regulation authorizing a health claim on noncariogenic carbohydrate sweeteners and dental caries to include isomaltulose, a noncariogenic sugar. View this document.

72 Fed. Reg. 51365 (September 7, 2007) (final rule) (to be codified at 21 C.F.R. Part 522). The agency is amending the animal drug regulations to reflect approval of a supplemental new animal drug application that provides for veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a sedative and analgesic in cats. View this document.

72 Fed. Reg. 51364 (September 7, 2007) (final rule) (to be codified at 21C.F.R. Part 522). The agency is amending the animal drug regulations to reflect approval of a new animal drug application that provides for veterinary prescription use of etodolac injectable solution in dogs for the control of pain and inflammation associated with osteoarthritis. View this document.

72 Fed. Reg. 49191 (August 28, 2007) (final rule) (to be codified at 21 C.F.R. Part 558). The agency is amending the animal drug regulations by removing those portions that reflect approval of a new animal drug application for a bacitracin zinc Type A medicated article. View this document.

72 Fed. Reg. 49282 (August 28, 2007) (notice). The agency is withdrawing approval of a new animal drug application for a bacitracin zinc Type A medicated article. View this document.

72 Fed. Reg. 46895 (August 22, 2007) (final rule) (to be codified at 21 C.F.R. Part 172). The agency amends the food additive regulations to provide for the safe use of glycerol ester of tall oil rosin to adjust the density of citrus oils used in the preparation of beverages and to provide for the use of steam stripping as a purification method for producing glycerol ester of wood rosin, gum rosin, or tall oil rosin. View this document.

72 Fed. Reg. 46562 (August 21, 2007) (final rule) (to be codified at 21 C.F.R. Part 172). The agency amends the food additive regulations to provide for the safe use of polydextrose as a bulking agent, formulation aid, humectant, and texturizer in all foods, except meat and poultry, baby foods, and infant formula. View this document.

72 Fed. Reg. 46375 (August 20, 2007) (final rule) (to be codified at 21 C.F.R. Part 101). The agency amends its food labeling regulations to permit the egg industry to place the safe handling statement for shell eggs on the inside lid of egg cartons if the statement "Keep Refrigerated" appears on the principal display panel (PDP) or information panel. View this document.

72 Fed. Reg. 45636 (August 15, 2007) (final rule) (to be codified at 21 C.F.R. Part 700). This final rule sets forth a correction to the rules governing recordkeeping requirements for human food and cosmetics manufactured from, processed with, or otherwise containing, material from cattle. View this document.

72 Fed. Reg. 45157 (August 13, 2007) (final rule) (to be codified at 21 C.F.R. Parts 510 and 529). The agency amends the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by B.L. Mitchell, Inc. The ANADA provides for the use of formalin in a water bath for the control of certain external parasites on finfish and shrimp and for the control of certain fungi on finfish eggs. View this document.

72 Fed. Reg. 43277 (August 3, 2007) (notice). The agency is announcing the availability of cooperative agreements for equipment, supplies, personnel, training, and facility upgrades to Food Emergency Response Laboratory Network (FERN) radiological laboratories of State, local, and tribal governments. View this document.

72 Fed. Reg. 42290 (August 2, 2007) (final rule) (to be codified at 21 C.F.R. Part 522). The agency amends the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for use of an oxytetracycline hydrochloride injectable solution in beef cattle, beef calves, nonlactating dairy cattle, and dairy calves for the treatment of various bacterial diseases. View this document.

72 Fed. Reg. 41619 (July 31, 2007) (final rule) (to be codified at 21 C.F.R. Part 584). The agency amends the animal drug regulations for food substances affirmed as generally recognized as safe (GRAS) in feed and drinking water of animals to correct a cross-reference. View this document.

72 Fed. Reg. 41618 (July 31, 2007) (final rule) (to be codified at 21 C.F.R. Part 558). The agency amends the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA revises the indications for use of two-way combination Type B and Type C medicated swine feeds formulated with ractopamine hydrochloride and tylosin phosphate. View this document.

72 Fed. Reg. 41010 (July 26, 2007) (final rule) (To be codified at21 C.F.R. Parts 20, 510, 514, and 516). The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. At this time, the agency is issuing final regulations to implement the act that describe the procedures for designating a new animal drug as a minor use or minor species drug. View this document.

72 Fed. Reg. 39815 (July 20, 2007) (notice). The agency is announcing a public hearing concerning the use of symbols to communicate nutrition information on food labels. View this document.

72 Fed. Reg. 39818 (July 20, 2007) (notice). The agency in collaboration with Georgia Food Safety and Defense Task Force, and the Metro Environmental Health Directors Food Service Advisory Committee, is announcing a public workshop entitled "Food Safety and Defense . . . Be ALERT!" View this document.

72 Fed. Reg. 37437 (July 10, 2007) (final rule) (to be codified at 21 C.F.R. Part 558). The agency is amending the animal drug regulations toreflect approval of a supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA revises the approved concentration of ivermectin in Type C medicated feed administered as a top dress to adult and breeding swine for the treatment and control of various internal and external parasites. View this document.

72 Fed. Reg. 37025 (July 6, 2007) (notice). The agency announces its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2007 (FY) to the University of Maryland, College Park to support the Joint Institute for Food Safety and Applied Nutrition. View this document.

72 Fed. Reg. 33386 (June 18, 2007) (final rule) (to be codified at 21 C.F.R. Part 558). The agency is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Div. of Pfizer, Inc. The supplemental NADA provides for the use of lincomycin in feed of swine weighing greater than 250 pounds and for the addition of a reproductive cautionary statement to labeling. View this document.

72 Fed. Reg. 27734 (May 17, 2007) (final rule) (to be codified at 21 C.F.R. Part 522). The agency is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for use of a one percent ivermectin solution by subcutaneous injection in cattle, swine, reindeer, and American bison for the treatment and control of various internal and external parasites. View this document.

72 Fed. Reg. 27733 (May 17, 2007) (final rule) (to be codified at 21 C.F.R. Part 522). The agency is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for the use of an ivermectin and clorsulon solution by subcutaneous injection in cattle for control of various internal and external parasites. View this document.

72 Fed. Reg. 26289 (May 9, 2007) (final rule) (to be codified at 21 C.F.R. Part 529). The agency is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for use of oxytetracycline hydrochloride soluble powder for skeletal marking of finfish fry and fingerlings by immersion. View this document.

72 Fed. Reg. 24185 (May 2, 2007) (final rule) (to be codified at 21 C.F.R. part 520). The agency is amending the animal drug regulations to correct an inadvertent error in the conditions of use of fenbendazole paste in horses and cattle. View this document.

72 Fed. Reg. 17394 (April 9, 2007) (final rule) (to be codified at 21 C.F.R. Part 179). The Food and Drug Administration is responding to objections and is denying requests that it has received for a hearing on the final rule that amended the food additive regulations by establishing a new maximum permitted energy level of x-rays for treating food of 7.5 million electron volts (MeV) provided that the x- rays are generated from machine sources that use tantalum or gold as the target material, with no change in the maximum permitted dose levels or uses currently permitted by FDA's food additive regulations. View this document.

72 Fed. Reg. 16291 (April 4, 2007) (proposed rule) (to be codified at 21 C.F.R. Part 179). The Food and Drug Administration is proposing to revise its labeling regulations applicable to foods (including dietary supplements) for which irradiation has been approved by FDA. View this document.

72 Fed. Reg. 15080 (March 30, 2007) (proposed rule) (to be codified at 21 C.F.R. Parts 211, 226, 300, 500, 530, 600, 895, and 1271). The Food and Drug Administration is reopening until May 14, 2007, the comment period for the proposed rule published in the Federal Register of January 12, 2007 (72 FR 1582). View this document.

72 Fed. Reg. 12560 (March 16, 2007) (final rule) (to be codified as 21 C.F.R. Part 584). The Food and Drug Administration is amending its regulations to affirm that the use of 25-hydroxyvitamin D3 is generally recognized as safe (GRAS) as a source of vitamin D3 activity in broiler chicken feeds and drinking water when used in accordance with certain limitations. View this document.

72 Fed. Reg. 12178 (March 15, 2007) (notice). The agency is announcing that a proposed information collection concerning substances prohibited from use in animal feed and animal proteins prohibited in ruminant feed has been submitted to the Office of Management and Budget for review and clearance. View this document.

72 Fed. Reg. 11989 (March 14, 2007) (proposed rule) (to be codified as 21 C.F.R. 113). The Food and Drug Administration is proposing to amend its regulations for thermally processed low-acid foods packaged in hermetically sealed containers to allow for use of other temperature-indicating devices, in addition to mercury-in-glass thermometers, during processing. View this document.

72 Fed. Reg. 11364 (March 13, 2007) (notice). The Food and Drug Administration is announcing the availability of a draft final guidance document entitled "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables" (the draft final fresh-cut guidance). View this document.

72 Fed. Reg. 11369 (March 13, 2007) (notice). The Food and Drug Administration is announcing that a collection of information entitled "Food Labeling; Trans Fatty Acids in Nutrition Labeling" has been approved by the Office of Management and Budget. View this document.

72 Fed. Reg. 10356 (March 8, 2007) (final rule) (to be codified as 21 C.F.R. Parts 71,73, 74, 170, 171, 172, 180, and 184). The Food and Drug Administration is amending its regulations that address food and color additives and generally recognized as safe (GRAS) substances. View this document.

72 Fed. Reg. 8750 (February 27, 2007) (notice). The Food and Drug Administration (FDA) is announcing two public hearings concerning the safety of fresh produce. View this document.

72 Fed. Reg. 8111 (February 23, 2007) (final rule) (to be codified as 21 C.F.R. Parts 71 and 171). The Food and Drug Administration (FDA) is announcing the effective date for the information collection requirements contained in a final rule published in the Federal Register of August 25, 2000 (65 FR 51758). The rule amended FDA's regulations on food additive and color additive petitions to permit an efficient joint review by both FDA and the Food Safety and Inspection Service of the U.S. Department of Agriculture, of petitions for approval to use a food ingredient or source of radiation in or on meat or poultry products. View this document.

72 Fed. Reg. 5367 (February 6, 2007) (proposed rule). The FDA is proposing to amend the regulation authorizing a health claim on the relationship between soluble fiber from certain foods and risk of coronary heart disease. The amendment proposes to exempt certain foods from the nutrient content requirement of "low fat." View this document.

72 Fed. Reg. 5442 (February 6, 2007) (notice). The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in co-sponsorship with the University of Arkansas (UA) Institute of Food Science and Engineering, is announcing a public workshop entitled "Food Defense Workshop." This public workshop is intended to provide information about food defense, the regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and other related subjects to FDA-regulated food facilities (farms, manufacturers, processors, distributors, retailers, and restaurants). View this document.

72 Fed. Reg. 2795 (January 26, 2007) (proposed rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is proposing to define the term "gluten-free" for voluntary use in the labeling of foods. View this document.

72 Fed. Reg. 1455 (January 12, 2007) (final rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is amending its food labeling regulations for the expanded use of the nutrient content claim "lean" on the labels of foods categorized as "mixed dishes not measurable with a cup" that meet certain criteria for total fat, saturated fat, and cholesterol content. This final rule responds to a nutrient content claim petition submitted by Nestl[eacute] Prepared Foods Co. (Nestl[eacute]) under the Federal Food, Drug, and Cosmetic Act (the act). View this document.

72 Fed. Reg. 1582 (January 12, 2007) (proposed rule) (to be codified at 21 C.F.R. Parts 211, 226, 300, 500, 530, 600, 895, and 1271). The Food and Drug Administration is proposing to prohibit the use of certain cattle material in, or in the manufacture (including processing) of, drugs, biologics, and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for use in ruminant animals (drugs for ruminants). FDA is also proposing new recordkeeping requirements for medical products for humans and drugs for ruminants that are manufactured from or otherwise contain material from cattle. View this document.

72 Fed Reg. 694 (January 8, 2007) (proposed rule) (to be codified at 21 C.F.R. Parts 101 and 170). The Food and Drug Administration is extending to March 5, 2007, the comment period for the notice of public hearing that appeared in the Federal Register of October 25, 2006 (71 FR 62400). In the notice of public hearing, FDA requested comments on how the agency should regulate conventional foods marketed as "functional foods" under its existing legal authority. View this document.

72 Fed. Reg. 497 (January 5, 2007) (proposed rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is proposing to amend the regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis. View this document.

72 Fed. Reg. 519 (January 5, 2007) (proposed rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is announcing that it is withdrawing certain proposed amendments of a proposed rule that published in the Federal Register of December 21, 1995, related to the calcium and osteoporosis health claim. View this document.

71 Fed. Reg. 76599 (December 21, 2006) (final rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is establishing January 1, 2010, as the uniform compliance date for food labeling regulations that are issued between January 1, 2007, and December 31, 2008. FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On March 14, 2005, FDA established January 1, 2008, as the uniform compliance date for food labeling regulations that issued between March 14, 2005, and December 31, 2006. View this document.

71 Fed. Reg. 74785 (December 13, 2006) (final rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is amending its nutrition labeling regulations for dietary supplements to provide that the quantitative amount and the percent of Daily Value of a dietary ingredient may be voluntarily presented on a "per day" basis in addition to the required "per serving" basis when a recommendation is made on the label that the dietary supplement be consumed more than once per day. View this document.

71 Fed. Reg. 67878 (November 24, 2006) (notice). The Food and Drug Administration, Office of Regulatory Affairs, Southwest Regional Office, in co-sponsorship with the Risk Management Small Business Development Center, is announcing a public workshop entitled "Food Defense Workshop." View this document.

71 Fed. Reg. 66231 (November 14, 2006) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to simplify the organization of special labeling requirements for formulations (Type A medicated articles, Type B and Type C medicated feeds) containing monensin sodium. View this document.

71 Fed. Reg 66335 (November 14, 2006) (notice). The Food and Drug Administration is announcing the availability of draft guidance for industry (136) entitled "Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods." This draft guidance provides FDA's recommendations for protocols for conducting the transfer study of a single-laboratory validated Type C medicated feed assay method to laboratories that have no experience with the test method. View this document.

71 Fed. Reg. 66336 (November 14, 2006) (notice). This notice announces the availability of a draft document entitled "Voluntary National Retail Food Regulatory Program Standards" (the Program Standards). The Program Standards are intended to help state, local, and tribal regulators design and manage a retail food regulatory program that is focused on the reduction of foodborne illness risk factors. View this document.

71 Fed. Reg. 62400 (October 25, 2006) (proposed rule) (to be codified at 21 C.F.R. Parts 101 and 170). The Food and Drug Administration is announcing a public hearing on the regulation of certain conventional foods that companies are marketing as "functional foods." The purpose of the hearing is for the agency to share its current regulatory framework and rationale regarding the safety evaluation and labeling of these foods, and to solicit information and comments from interested persons on how FDA should regulate these foods under the agencys existing legal authority. View this document.

71 Fed. Reg. 56006 (September 26, 2006) (notice). The Food and Drug Administration is announcing the availability of a guidance entitled "Questions and Answers Regarding Establishment and Maintenance of Records (Edition 4)." The guidance responds to various questions raised about the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the agencys implementing regulation, which requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and the immediate subsequent recipients of food. View this document.

71 Fed. Reg. 54500 (September 15, 2006) (notice). The Food and Drug Administration is announcing an amendment to the notice of the meeting of the Transmissible Spongiform Encephalopathies Advisory Committee. View this document.

71 Fed. Reg. 51726 (August 31, 2006) (final rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is amending its nutrition labeling of dietary supplements regulations. View this document.

71 Fed. Reg. 47439 (August 17, 2006) (final rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is correcting a final rule that appeared in the Federal Register of July 25, 2006 (71 FR 42031). The document amended the voluntary nutrition labeling regulations by updating the names and the nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States. View this document.

71 Fed. Reg. 42031 (July 26, 2006) (final rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is amending the voluntary nutrition labeling regulations by updating the names and the nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States and clarifying guidelines for the voluntary nutrition labeling of these foods. View this document.

71 Fed. Reg. 38650 (July 7, 2006) (notice). The Food and Drug Administration is announcing the withdrawal of a compliance policy guide regarding human labeled drugs distributed and used in animal medicine that was issued on March 19, 1991. View this document.

71 Fed. Reg. 38650 (July 7, 2006) (notice). The Food and Drug Administration is announcing the withdrawal of the compliance policy guide (CPG) entitled "Sec. 616.100 Streptomycin Residues in Cattle Tissues (CPG 7125.22)." This CPG is obsolete. View this document.

71 Fed. Reg. 35688 (June 21, 2006) (notice). The Food and Drug Administration is announcing the availability of a final guidance for industry entitled "Recommendations for the Early Food Safety Evaluation of New Non- Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use." View this document.

71 Fed. Reg. 28872 (May 18, 2006) (notice). The Food and Drug Administration is announcing the availability of a guidance document entitled "Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition" (the guidance).     View this document.

71 Fed. Reg. 27263 (May 10, 2006) (notice). The Food and Drug Administration, Office of Regulatory Affairs, Southwest Regional Small Business Representative Program, in collaboration with The University of Arkansas and the Mid-Continental Association of Food and Drug Officials, is announcing a public workshop entitled "Food Safety and Defense Workshop." This public workshop is intended to provide information about current Good Manufacturing Practice regulations for foods, Hazard Analysis Critical Control Point, food defense awareness, and other related subjects to the regulated industry, particularly small businesses and startups.     View this document.

71 Fed. Reg. 28872 (May 18, 2006) (notice). The Food and Drug Administration is announcing the availability of a guidance document entitled "Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition" (the guidance).     View this document.

71 Fed. Reg. 27263 (May 10, 2006) (notice). The Food and Drug Administration, Office of Regulatory Affairs, Southwest Regional Small Business Representative Program, in collaboration with The University of Arkansas and the Mid-Continental Association of Food and Drug Officials, is announcing a public workshop entitled "Food Safety and Defense Workshop." This public workshop is intended to provide information about current Good Manufacturing Practice regulations for foods, Hazard Analysis Critical Control Point, food defense awareness, and other related subjects to the regulated industry, particularly small businesses and startups.     View this document.

71 Fed. Reg. 11209 (March 6, 2006) (notice). The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables" (the draft fresh-cut guidance).       View this document.

71 Fed. Reg. 9448 (February 24, 2006) (final rule) (to be codified at 21 C.F.R. Part 73). The Food and Drug Administration is responding to two objections that it received on the final rule that amended the color additive regulations authorizing the use of tomato lycopene extract and tomato lycopene concentrate as color additives in foods. After reviewing the objections to the final rule, the agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for modifying the amendment to the regulation. FDA is also establishing a new effective date for this color additive regulation, which was stayed by the filing of proper objections.       View this document.

71 Fed. Reg. 8597 (February 17, 2006) (notice). The Food and Drug Administration is announcing the availability of a document entitled "Guidance for Industry and FDA Staff: Whole Grain Label Statements." The draft guidance is intended to provide guidance to industry about what the agency considers to be "whole grain" and to assist manufacturers in labeling their products.       View this document.

71 Fed. Reg. 2147 (January 13, 2006) (notice; correction). The Food and Drug Administration is correcting a notice that appeared in the Federal Register of January 4, 2006 (71 FR 349). The document announced a public workshop entitled "UA/FDA Food Labeling Workshop." The document was published with a typographical error in the SUPPLEMENTARY INFORMATION section. This document corrects that error.       View this document.

70 Fed. Reg. 941 (January 6, 2006) (notice). The Food and Drug Administration published a notice in the Federal Register of December 14, 2005 announcing the availability of a guidance document entitled, "Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006." This notice announces to all interested persons that there is an addendum to that guidance.       View this document.

71 Fed. Reg. 349 (January 4, 2006) (notice). The Food and Drug Administration, Office of Regulatory Affairs, Southwest Regional Small Business Representative Program, in collaboration with The University of Arkansas, is announcing a public workshop entitled "UA/FDA Food Labeling Workshop." This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups.       View this document.

70 Fed. Reg. 76684 (December 28, 2005) (notice). The Food and Drug Administration published in the Federal Register of August 28, 2003, a direct final rule to amend the regulation on the designation of ingredients in dietary supplements by incorporating by reference the most recent editions of the references Herbs of Commerce and the International Code of Botanical Nomenclature. The direct final rule also would have added a sentence to this regulation codifying the requirements contained in the 2002 Farm Bill that restrict the use of the term "ginseng" as a common or usual name to botanicals within the genus "Panax" and limiting the use of the term "ginseng" to labeling and advertising of herbs or herbal ingredients classified within the genus "Panax." FDA is withdrawing the direct final rule because the agency received significant adverse comment.       View this document.

70 Fed. Reg. 76150 (December 23, 2005) (interim final rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is amending the regulation authorizing a health claim on the relationship between oat beta-glucan soluble fiber and reduced risk of coronary heart disease.       View this document.

70 Fed. Reg. 71041 (November 25, 2005) (proposed rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is proposing to amend its food labeling regulations for the expanded use of the nutrient content claim "lean" on the labels of foods categorized as "mixed dishes not measurable with a cup" that meet certain criteria for total fat, saturated fat, and cholesterol content.       View this document.

70 Fed. Reg. 60749 (October 19, 2005) (notice). The Food and Drug Administration is announcing a public meeting entitled "Assessing Consumer Perceptions of Health Claims." The meeting will present research assessing consumers' reactions to health claims and will address the implications of these studies for future research designed to evaluate consumer understanding of health claims and the effect of health claims on consumer perceptions and behaviors.       View this document.

70 Fed. Reg. 60095 (October 14, 2005) (notice). This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration. The meeting will be open to the public. The name of the committee is the Transmissible Spongiform Encephalopathies Advisory Committee.       View this document.

70 Fed. Reg. 58570 (October 6, 2005) (proposed rule) (to be codified at 21 C.F.R. Part 589). The Food and Drug Administration is proposing to amend the agency's regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals.       View this document.

70 Fed. Reg. 57505 (October 3, 2005) (final rule) (to be codified at 21 C.F.R. Parts 1 and 20). The Food and Drug Administration is issuing a final regulation that confirms the interim final rule entitled "Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2000" (68 FR 58894, October 10, 2003 (interim final rule) as corrected by a technical amendment (69 FR 29428, May 24, 2004), and responds to comments submitted in response to the request for comments in the interim final rule. This final rule affirms the interim final rule's requirement that domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States be registered with FDA by December 12, 2003.       View this document.

70 Fed. Reg. 56828 (September 29, 2005) (final rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is amending its regulations concerning the maximum sodium levels permitted for foods that bear the implied nutrient content claim "healthy."       View this document.

70 Fed. Reg. 56409 (September 27, 2005) (proposed rule) (to be codified at 21 C.F.R. Part 135). The Food and Drug Administration is announcing that the following two petitions have been filed: A petition requesting that the agency revoke the standards of identity for goat's milk ice cream and mellorine, and amend the standards of identity for ice cream and frozen custard, sherbet, and water ices in numerous respects; and a petition requesting that the agency amend the standard of identity for parmesan and reggiano cheese to decrease the minimum curing time from 10 months to 6 months. The FDA is issuing an advance notice of proposed rulemaking to request comments to determine whether the action proposed in the petitions would promote honesty and fair dealing in the interest of consumers.       View this document.

70 Fed. Reg. 53063 (September 7, 2005) (final rule) (to be codified at 21 C.F.R. Parts 189 and 700). The Food and Drug Administration is amending the interim final rule on use of materials derived from cattle in human food and cosmetics published in the Federal Register of July 14, 2004.       View this document.

70 Fed. Reg. 48057 (August 16, 2005) (final rule) (to be codified at 21 C.F.R. Part 179). The Food and Drug Administration is amending the food additive regulations to provide for the safe use of ionizing radiation for control of Vibrio species and other foodborne pathogens in fresh or frozen molluscan shellfish (e.g., oysters, mussels, clams, etc.). This action is in response to a petition filed by the National Fisheries Institute and the Louisiana Department of Agriculture and Forestry.       View this document.

70 Fed. Reg. 36189 (June 22, 2005) (notice). The Food and Drug Administration is announcing the availability of a revised guidance for industry entitled "General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals (GFI 3)." This version of the guidance replaces the version that was made available in July 1994. This has been revised to remove outdated information on toxicological testing and to provide references to other available guidance on the topic. In addition, the document has been revised to address minor formatting issues.       View this document.

70 Fed. Reg. 36190 (June 22, 2005) (notice). The Food and Drug Administration is announcing the availability of a revised guidance document entitled "Guidance for Industry and FDA: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile."       View this document.

70 Fed. Reg. 33404 (June 8, 2005) (proposed rule) (to be codified at 21 C.F.R. Part 1). The Food and Drug Administration is extending to July 25, 2005, the comment period for the document that appeared in the Federal Register of May 10, 2005. In the document, FDA reopened the comment period until June 9, 2005, for the agency's proposed rule entitled "Prevention of Salmonella Enteritidis in Shell Eggs During Production."       View this document.

69 Fed. Reg. 29214 (May 20, 2005) (proposed rule) (to be codified at 21 C.F.R. Part 130). The Food Safety and Inspection Service and the Food and Drug Administration are proposing to establish a set of general principles for food standards. The adherence to these principles will result in standards that will better promote honesty and fair dealing in the interest of consumers and protect the public, allow for technological advances in food production, be consistent with international food standards to the extent feasible, and be clear, simple, and easy to use for both manufacturers and the agencies that enforce compliance with the standards.       View this document.

69 Fed. Reg. 25461 (May 13, 2005) (final rule) (to be codified at 21 C.F.R. Part 21). The Food and Drug Administration is announcing a series of domestic public meetings to discuss the final regulation implementing section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.       View this document.

69 Fed. Reg. 25496 (May 13, 2005) (proposed rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is proposing to amend the regulation authorizing a health claim on noncariogenic carbohydrate sweeteners and dental caries, i.e., tooth decay, to include sucralose, a nonnutritive sweetener.       View this document.

69 Fed. Reg. 24490 (May 10, 2005) (proposed rule) (to be codified at 21 C.F.R. Part 1). The Food and Drug Administration (FDA) is reopening until June 9, 2005, the comment period for the agency’s proposed rule entitled "Prevention of Salmonella Enteritidis in Shell Eggs During Production" that published in the Federal Register of September 22, 2004 (69 FR 56824).       View this document.

69 Fed. Reg. 23813 (May 5, 2005) (proposed rule) (to be codified at 21 C.F.R. Part 21). The Food and Drug Administration is proposing to amend the agency's food labeling regulations to permit the egg industry to place the safe handling statement for shell eggs on the inside lid of egg cartons if the statement "Keep Refrigerated" appears on the principal display panel or information panel.       View this document.

69 Fed. Reg. 22888 (May 3, 2005) (notice). The Food and Drug Administration (FDA) is extending to July 5, 2005, the comment period for the notice that requested comments and scientific data and information to assist the agency in its plans to conduct a risk assessment for Listeria monocytogenes in smoked finfish and to evaluate the provisions of the 2001 Food Code that address preventive controls for L. monocytogenes in retail and foodservice establishments.       View this document.

70 Fed. Reg 20048 (April 22, 2005) (notice). The Food and Drug Administration is announcing a public meeting to elicit information on the current science related to foodborne illness associated with the consumption of sprouts.       View this document.

70 Fed. Reg. 16923 (April 4, 2005)(final rule)(to be codified at 21 C.F.R. Part 520).The Food and Drug Administration is amending the animal drug regulations to reflect the limitations to conditions of use for products approved under 22 new animal drug applications and 5 abbreviated new animal drug applications. FDA is also amending the animal drug regulations to reflect the approved preslaughter withdrawal periods and milk withholding period in cattle following use of penicillin G procaine aqueous suspension.       View this document.

70 Fed. Reg. 17008 (April 4, 2005) (proposed rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking to request comment on whether to amend certain provisions of the agency's nutrition labeling regulations to give more prominence to calories on food labels.       View this document.

70 Fed. Reg. 16995 (April 4, 2005) (proposed rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration (FDA) is reopening until June 3, 2005, the comment period for a proposed rule published in the Federal Register of March 20, 2002. In that document, FDA proposed to amend its voluntary nutrition labeling regulations by updating the names and nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States. Since publication of the proposed rule, the agency has received new data in comments that it intends to use to further update the nutrition labeling values. The agency also intends to use additional data from the U.S. Department of Agriculture for certain nutrients in raw produce.       View this document.

70 Fed. Reg. 17010 (April 4, 2005) (proposed rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is issuing this advance notice of proposed rulemaking to request comment on whether to amend certain provisions of the agency's nutrition labeling regulations concerning serving size.       View this document.

70 Fed. Reg. 14472 (March 22, 2005) (notice). The Food and Drug Administration (FDA) is requesting nominations for a nonvoting industry representative to serve on the Food Advisory Committee in FDA's Center for Food Safety and Applied Nutrition.       View this document.

70 Fed. Reg. 13009 (March 18, 2005) (final rule) (to be codified at 21 C.F.R. Part 573) . The Food and Drug Administration is amending the animal food additive regulations to correct the specifications for two food additives used in cattle feed.       View this document.

70 Fed. Reg. 12414 (March 14, 2005) (final rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration is establishing January 1, 2008, as the uniform compliance date for food labeling regulations that are issued between March 14, 2005, and December 31, 2006.    View this document.

70 Fed. Reg. 8726 (February 23, 2005) (final rule) (to be codified at 21 C.F.R. Part 1). The Food and Drug Administration is correcting a final regulation that appeared in the Federal Register of December 9, 2004. The document issued a final regulation that requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records allow for the identification of the immediate previous sources and immediate subsequent recipients of food.    View this document

70 Fed. Reg. 8513 (February 23, 2005) (final rule) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application filed by Cross Vetpharm Group Ltd. The ANADA provides for oral use of ivermectin paste in horses for treatment and control of various internal parasites or parasitic conditions.    View this document

70 Fed. Reg. 2567 (January 14, 2005) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications filed by Alpharma Inc.    View this document

70 Fed. Reg. 2566 (January 14, 2005) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of a melengestrol acetate liquid Type A medicated article to make Type C medicated feeds for heifers fed in confinement for slaughter and for heifers intended for breeding.    View this document.

70 Fed. Reg. 2352 (January 13, 2005) (final rule) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The ANADA provides for use of levamisole hydrochloride soluble powder to make a drench solution for oral administration to cattle and sheep which is effective against various internal parasites.    View this document.

70 Fed. Reg. 2415 (January 13, 2005) (notice). The Food and Drug Administration is announcing that Alltech, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of polyurethane polymer coating in ruminant feed.    View this document

70 Fed. Reg. 1817 (January 11, 2005) (final rule) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Merial, Ltd. The NADA provides for use of ivermectin meal for the control of various species of internal parasites in horses.    View this document.

70 Fed. Reg. 1820 (January 11, 2005) (final rule) (to be codified at 21 C.F.R. Part 520). The Food and Drug Administration is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for oral use of lincomycin soluble powder to make medicated drinking water for administration to swine for the treatment of swine dysentery or to broiler chickens for the control of necrotic enteritis.    View this document

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