Federal Register Digest Archive
Food and Drug Administration (FDA)
69 Fed. Reg. 78305 (December 30, 2004) (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 which provides for revised reproductive safety labeling of tilmicosin Type A medicated article used in medicated swine feeds.
View this document: |
69 Fed. Reg. 78303 (December 30, 2004) (final rule) (to be codified at 21 CFR Part 173). The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of acidified sodium chlorite solutions as an antimicrobial agent on finfish and crustaceans.
View this document: |
69 Fed. Reg. 78308 (December 29, 2004). (notice). The Food and Drug Administration (FDA) is extending to January 25, 2005, the comment period for the notice that appeared in the Federal Register of November 26, 2004 (69 FR 68948). In the notice, FDA announced the availability and requested comments on the draft guidance entitled "Proposed Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Live and Perishable Fish and Fishery Products for Export to the European Union and the European Free Trade Association." The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
View this document: |
69 Fed. Reg. 76844 (December 23, 2004) (final rule) (to be codified at 21 C.F.R. Part 179). The Food and Drug Administration is amending 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: |
69 Fed. Reg. 76401 (December 21, 2004) (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 a source of fast neutrons to inspect containers that may contain food.
View this document: |
69 Fed. Reg. 71562 (December 9, 2004) (final rule) (to be codified at 21 CFR 1 and 11). The Food and Drug Administration is issuing 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 are to allow for the identification of the immediate previous sources and immediate subsequent recipients of food. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and is necessary to help address credible threats of serious adverse health consequences or death to humans or animals.
View this document: |
69 Fed. Reg. 71418 (December 9, 2004) (notice). The Food and Drug Administration (FDA) is announcing that a temporary permit has been issued to Wells' Dairy, Inc., to market test cottage cheese that deviates from the U.S. standard of identity for cottage cheese. The purpose of the temporary permit is to allow the applicant to measure consumer acceptance of the product, identify mass production problems, and assess commercial feasibility.
View this document: |
69 Fed. Reg. 67513 (November 18, 2004) (proposed rule). The Food and Drug Administration (FDA) is reopening for 60 days the comment period for the proposed rule entitled "Food Labeling: Nutrient Content Claims, General Principles; Health Claims, General Requirements and Other Specific Requirements for Individual Health Claims." In that document, FDA proposed to amend its existing nutrient content claims and health claims regulations to provide additional flexibility in the use of these claims on food products. FDA reopened the comment period for the 1995 proposal to seek comment on the proposed amendments to permit unqualified health claims on certain foods that do not contain 10 percent or more of one of certain required nutrients, the proposed amendments to provide criteria that FDA would consider in determining whether to grant an exemption from disqualifying nutrient levels related to unqualified health claims of certain nutrients, and the proposed amendments to retain the word "may" or "might" in unqualified health claims. In addition, FDA sought comment on the proposed use of unlisted synonyms and abbreviated health claims. The comment period for the 1995 proposal closed on July 6, 2004. FDA is reopening the comment period again in response to four requests for additional time to submit comments to FDA.
View this proposed rule: |
69 Fed. Reg. 67263 (November 17, 2004) (final rule) (to be codified at 21 C.F.R. Part 558). The Food and Drug Administration is amending its animal drug regulations to more accurately describe the approved feeding instructions for decoquinate Type C medicated feeds for cattle and calves, including nonruminating veal calves, and for young sheep and young goats. This action is being made to improve the accuracy of the regulations.
View this final rule: |
69 Fed. Reg. 65540 (November 15, 2004) (final rule) (to be codified at 21 C.F.R. Part 180). The Food and Drug Administration is amending the food additive regulations to permit the manufacture of mannitol by fermentation of sugars such as fructose, glucose, or maltose by the action of the microorganism Lactobacillus intermedius. This action is in response to a petition filed by zuChem, Inc.
View this final rule: |
69 Fed. Reg. 65202 (November 10, 2004) (notice). The Food and Drug Administration is announcing the availability of the draft guidance for industry (123) entitled "Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for Use in Animals." This draft guidance is intended to provide specific advice regarding the development of target animal safety and effectiveness data to support approval of veterinary NSAIDs, specifically cyclooxygenase inhibitors.
View this notice: |
69 Fed. Reg. 60108 (October 7, 2004) (proposed rule) (to be codified at 21 C.F.R. Parts 16 and 118). The Food and Drug Administration (FDA) is announcing a series of public meetings to discuss the proposed rule for prevention of Salmonella Enteritidis in shell eggs during production. On September 22, 2004, FDA published in the Federal Register a proposed rule for egg safety national standards. The purpose of these meetings is to solicit public comments on the proposed rule and provide the public an opportunity to ask questions.
View this proposed rule: |
69 Fed. Reg. 59932 (October 6, 2004) (notice). The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Food Advisory Committee (the Parent Committee) and certain subcommittees of the Food Advisory Committee in FDA's Center for Food Safety and Applied Nutrition (CFSAN). Nominations will be accepted for current vacancies and those that will or may occur through June 30, 2005. FDA has special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.
View this notice: |
69 Fed. Reg. 58371 (September 30, 2004) (proposed rule) (to be codified at 21 C.F.R. Part 170). The Food and Drug Administration (FDA) is announcing the withdrawal of its advance notice of proposed rulemaking (ANPRM) published in the Federal Register of May 21, 2002 that requested input on whether the agency should establish regulations permitting the licensing of the rights to manufacture and market a food contact substance for a use that is the subject of an effective food contact notification. FDA is withdrawing the ANPRM based upon comments indicating that such a regulation would not be necessary.
View this proposed rule: |
69 Fed. Reg. 58448 (September 30, 2004) (notice). The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Use of Material from BSE-Positive Cattle in Animal Feed." This guidance document describes FDA's current thinking regarding the use in all animal feed of all material from cattle that test positive for BSE (bovine spongiform encephalopathy).
View this notice: |
69 Fed. Reg. 56823 (September 22, 2004) (proposed rule) (to be codified at 21 C.F.R. Parts 16 and 118).The Food and Drug Administration (FDA) is proposing to require shell egg producers to implement measures to prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm. This action is being taken because of the number of outbreaks of foodborne illnesses and deaths caused by SE that are associated with the consumption of shell eggs that have not been treated to destroy this pathogen.
View this proposed rule: |
69 Fed. Reg. 56770 (September 22, 2004) (notice). The Food and Drug Administration (FDA) is announcing a public meeting (via satellite downlink) entitled "Measuring the Effectiveness of the Nation's Foodservice and Retail Food Protection System." The purpose of the meeting is to discuss the report entitled "FDA Report on the Occurrence of Foodborne Illness Risk Factors Within Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004)" and to provide information to the public to improve food preparation practices and food employee behaviors at institutional food service establishments, restaurants, and retail food stores.
View this notice: |
69 Fed. Reg. 56771 (September 22, 2004) (notice). This notice announces a forthcoming public meeting of the Transmissible Spongiform Encephalopathies Advisory Committee.
View this notice: |
69 Fed. Reg. 56771 (September 22, 2004) (notice). The Food and Drug Administration (FDA) is announcing the availability of a report entitled "FDA Report on the Occurrence of Foodborne Illness Risk Factors Within Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004)." The Report summarizes results from a data collection conducted in 2003 on risk factors which have been identified as contributing to foodborne illness in institutional foodservice establishments, restaurants, and retail food stores: food from unsafe sources; inadequate cooking; improper holding temperature; contaminated equipment; and poor personal hygiene.
View this notice: |
69 Fed. Reg. 55824 (September 16, 2004) (notice). This notice announces a forthcoming public meeting of a public advisory committee of the Food and Drug Administration. The name of the committee is the Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants, also known as the Ranch Hand Advisory Committee.
View this notice: |
69 Fed. Reg. 53615 (September 2, 2004) (final rule) (to be codified at 21 C.F.R. Part 20). The Food and Drug Administration is amending its public information regulations to implement more comprehensively the exemptions contained in the Freedom of Information Act. This action incorporates exemptions one, two, and three of FOIA into FDA's public information regulations.
View this final rule: |
69 Fed. Reg. 53662 (September 2, 2004) (proposed rule) (to be codified at 21 C.F.R. Part 20). The Food and Drug Administration (FDA) is proposing to amend its public information regulations to implement more comprehensively the exemptions contained in the Freedom of Information Act. This action incorporates exemptions one, two, and three of FOIA into FDA's public information regulations.
View this proposed rule: |
69 Fed. Reg. 51469 (August 19, 2004) (notice). The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols," dated August 2004. The guidance document provides guidance to sponsors of clinical trials for certain products on when and how to request from FDA the engagement of an independent consultant to participate in the review of protocols for clinical studies intended to serve as the primary basis of claims of efficacy. This guidance document finalizes the draft guidance of the same title dated May 2003.
View this notice: |
69 Fed. Reg. 50388 (August 16, 2004) (notice). The Food and Drug Administration (FDA) is announcing the availability of a contingency plan that provides guidance on submitting prior notice of imported food during system outages affecting the applicable FDA and Customs and Border Protection (CBP) program systems.
View this notice: |
69 Fed. Reg. 50389 (August 16, 2004) (notice). The Food and Drug Administration (FDA) is announcing the availability of a revised compliance policy guide (CPG) Sec. 110.310 entitled "Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." The CPG provides written guidance to FDA's and Customs and Border Protection's staff on enforcement of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the agency's implementing regulations, which require prior notice for all food imported or offered for import into the United States.
View this notice: |
69 Fed. Reg. 50206 (August 13, 2004) (notice). The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Hazard Analysis and Critical Control Point; Procedures for the Safe and Sanitary Processing and Importing of Juice" has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995.
View this notice: |
69 Fed. Reg. 47765 (August 6, 2004) (notice). The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Questions and Answers Regarding the Interim Final Rule on Registration of Food Facilities (Edition 4)." The guidance responds to various questions raised about section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the agency's implementing regulation, which require facilities that manufacture, process, pack, or hold food for consumption in the United States to register with FDA by December 12, 2003.
View this notice: |
69 Fed. Reg. 45336 (July 29, 2004) (notice). The Food and Drug Administration (FDA) is announcing the availability of a compliance policy guide (CPG) entitled "Guidance Levels for Radionuclides in Domestic and Imported Foods." This document is intended to make FDA offices and the industry aware of FDA's guidance for enforcement concerning radionuclide activity concentration in domestic food in interstate commerce or food offered for import. This CPG rescinds and replaces CPG Sec. 560.750 Radionuclides in Imported Foods--Levels of Concern (CPG 7119.14). The agency also is announcing the availability of a final supporting document entitled "Supporting Document for Guidance Levels for Radionuclides in Domestic and Imported Foods."
View this notice: |
69 Fed. Reg. 43001 (July 19, 2004) (notice). The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
View this notice: |
69 Fed. Reg. 42443 (July 15, 2004) (notice). The Food and Drug Administration (FDA) is withdrawing a guidance for industry (172) entitled "Use of Unapproved Hormone Implants in Veal Calves." This guidance, which was issued on April 2, 2004, is being withdrawn because the policy contained within it only applied to veal calves presented for slaughter prior to June 6, 2004.
View this notice: |
69 Fed. Reg. 42255 (July 14, 2004) (final rule) (to be codified at 21 C.F.R. Parts 189 and 700). The Food and Drug Administration (FDA) is issuing an interim final rule (interim final rule) to prohibit the use of certain cattle material, to address the potential risk of bovine spongiform encephalopathy (BSE), in human food, including dietary supplements, and cosmetics. The FDA also is proposing to require that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain material from cattle establish and maintain records sufficient to demonstrate that the food and cosmetics are in compliance with this interim final rule.
View this final rule: |
69 Fed. Reg. 42274 (July 14, 2004) (proposed rule) (to be codified at 21 C.F.R. Part 589). Following detection of bovine spongiform encephalopathy (BSE) in an imported dairy cow in Washington State in December 2003, the Secretaries of the U.S. Departments of Agriculture and Health and Human Services announced a series of regulatory actions and policy changes to strengthen protections against the spread of BSE in U.S. cattle and against human exposure to the BSE agent. The Secretary of Agriculture also convened an international panel of experts on BSE to review the U.S. response to the Washington case and make recommendations that could provide meaningful additional public or animal health benefits. The purpose of this advance notice of proposed rulemaking is to inform the public about the panel's recommendations and to solicit comment on additional measures under consideration based on those recommendations and other considerations.
View this proposed rule: |
69 Fed. Reg. 42274 (July 14, 2004) (21 C.F.R. Parts 189 and 700). The Food and Drug Administration (FDA) is proposing to require that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle must establish and maintain records sufficient to demonstrate the food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials. This is a companion rulemaking to FDA's interim final rule entitled "Use of Materials Derived From Cattle in Human Food and Cosmetics," published in this issue of the Federal Register. FDA is proposing recordkeeping requirements because records documenting the absence of prohibited cattle materials are needed by manufacturers and processors of human food and cosmetics that contain cattle material to ensure that these products do not contain prohibited cattle materials. In addition, such records are necessary to help FDA ensure compliance with the requirements of the interim final rule.
View this document: |
69 Fed. Reg. 42191 (July 14, 2004) (notice). The Food and Drug Administration (FDA) is announcing the availability of a risk assessment regarding the potential for variant Creutzfeldt-Jakob Disease (vCJD) in humans from exposure to cosmetics containing cattle-derived protein infected with the bovine spongiform encephalopathy (BSE) agent. FDA is making this document available to communicate publicly the potential risk to public health from cosmetics made with cattle materials that may be contaminated with the BSE agent.
View this notice: |
69 Fed. Reg. 33393 (June 15, 2004) (notice). The Food and Drug Administration (FDA) is announcing a public meeting to elicit information from stakeholders concerning key elements of FDA's new produce safety action plan entitled "Produce Safety From Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated With Fresh Produce." The new produce safety action plan will be forthcoming and posted http://www.foodsafety.gov/dms/fs- toc.html prior to the public meeting. FDA requests that those who speak at the meeting or otherwise provide FDA with their comments focus on the questions set out in section II of this document concerning the draft of the produce safety action plan.
View this notice: |
69 Fed. Reg. 32863 (June 14, 2004) (final rule) (to be codified at 21 C.F.R. Part 110). The Food and Drug Administration (FDA) previously announced three public meetings intended to obtain comments about FDA's current good manufacturing practice (CGMP) in manufacturing, packing, or holding human food regulations; these comments will be useful in determining appropriate revisions to these regulations. FDA is announcing the rescheduling of the public meeting planned for June 11, 2004, in College Park, MD. FDA is also announcing the cancellation of the public meeting originally scheduled for July 2, 2004, in Monterey, CA. The public meeting scheduled for July 21, 2004, in Chicago, IL, will occur as originally planned.
View this final rule: |
69 Fed. Reg. 33040 (June 14, 2004) (notice). The Food and Drug Administration is announcing that a collection of information entitled "Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Fee" has been approved by the Office of Management and Budget.
View this notice: |
69 Fed. Reg. 33040 (June 14, 2004) (notice). The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the recordkeeping requirements for manufacturers of medicated animal feeds.
View this notice: |
69 Fed. Reg. 33043 (June 14, 2004) (notice). The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Food Labeling Regulations" has been approved by the Office of Management and Budget.
View this notice: |
69 Fed. Reg. 31659 (June 4, 2004) (final rule) (21 CFR Parts 1, 10, and 16). The Food and Drug Administration (FDA) is issuing a final regulation that provides procedures for the detention of an article of food, if an officer or qualified employee of FDA has credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals.
View this final rule: |
69 Fed. Reg. 30842 (June 1, 2004) (notice of advanced rulemaking). The Food and Drug Administration (FDA) is considering whether to revise its regulations pertaining to export notification and recordkeeping. FDA has received a petition for reconsideration claiming that the it lacks legal authority to inspect export records held by food and cosmetic companies. The petition also claimed that the regulations describing the types of records that should be kept to demonstrate that an exported product does not conflict with the foreign country's laws are overly burdensome. FDA is inviting comment on the issues raised by the petition.
View this notice of advanced rulemaking: |
69 Fed. Reg. (May 26, 2004) (proposed rule; correction) (to be codified at 21 C.F.R. Part 59). The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of April 29, 2004. The document proposed new regulations for persons who use sampling services (services that collect samples for another party) and private laboratories used in connection with imported food. The document was published with inadvertent errors. This document corrects those errors.
View this proposed rule; correction: |
69 Fed. Reg. 29564 (May 24, 2004) (notice). The Food and Drug Administration (FDA) is announcing that a petition has been filed that requests that the agency establish a regulatory limit of 100 colony forming units per gram for Listeria monocytogenes in foods that do not support the growth of the microorganism. The agency is requesting comment on the petition. The agency is also requesting the submission of relevant data and information to assist it in evaluating and responding to the petition.
View this notice: |
69 Fed. Reg. 29428 (May 24, 2004) (final rule) (to be codified at 21 C.F.R. Part 1). The Food and Drug Administration (FDA) published an interim final rule in the Federal Register of October 10, 2003. The interim final rule requires domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States, to register with FDA by December 12, 2003. Due to several errors in Sec. Sec. 1.231 and 1.232 the interim final rule contains some incorrect information. This document corrects those errors.
View this final rule: |
69 Fed. Reg. 29220 (May 21, 2004) (final rule) (to be codified at 21 C.F.R. Part 110). The Food and Drug Administration (FDA) is announcing three public meetings to solicit comments, data, and scientific information about the current state of quality management techniques, quality systems approaches, and voluntary industry standards concerning current good manufacturing practices and other controls used by food manufacturers and processors to prevent, reduce, control, or eliminate food borne hazards that can occur during food production or processing. The meetings are intended to elicit information about FDA's current good manufacturing practice (CGMP) in manufacturing, packing, or holding human food regulations. This information will be useful in determining appropriate revisions to these regulations.
View this final rule: |
69 Fed. Reg. 29140 (May 20, 2004) (notice). The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry entitled "Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores." The purpose of this document is to provide guidance on the manufacture and labeling of foods that contain raw meat, or other raw animal tissues, for consumption by dogs, cats, other companion or pet animals, and captive noncompanion animal carnivores and omnivores.
View this notice: |
69 Fed. Reg. 28060 (May 18, 2004) (final rule) (to be codified at 21 C.F.R. Part 1). The Food and Drug Administration (FDA) is extending to July 13, 2004, the comment period on the prior notice interim final rule that appeared in the Federal Register of October 10, 2003 (68 FR 58974). The prior notice 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 final rule: |
69 Fed. Reg. 24541 (May 4, 2004) (proposed rule) (to be codified at 21 C.F.R. 101). The Food and Drug Administration is reopening for 60 days the comment period for the proposed rule entitled "Food Labeling: Nutrient Content Claims, General Principles; Health Claims, General Requirements and Other Specific Requirements for Individual Health Claims" (the 1995 proposal).
View this proposed rule: |
69 Fed. Reg. 24070 (May 3, 2004) (notice). The Food and Drug Administration is announcing the availability of a revised guidance entitled "Questions and Answers Regarding the Interim Final Rule on Prior Notice of Imported Food (Edition 2)." The guidance responds to various questions raised about section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the agency's implementing regulation, which require 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 notice: |
69 Fed. Reg. 23460 (April 29, 2004) (proposed rule) (to be codified at 21 C.F.R. Part 59). The Food and Drug Administration (FDA) is proposing new regulations for persons who use sampling services (services that collect samples for another party) and private laboratories used in connection with imported food. The proposal would require samples to be properly identified, collected, and maintained. Additionally, the proposal would require laboratories to use validated or recognized analytical methods, and to submit analytical results directly to FDA. The proposal is intended to help assure the integrity and scientific validity of data and results submitted to FDA.
View this proposed rule: |
69 Fed. Reg. 20838 (April 19, 2004) (proposed rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration (FDA) is extending for 60 days the comment period for an advanced notice of proposed rulemaking published in the Federal Register of July 11, 2003. FDA reopened the comment period in the Federal Register of March 1, 2004. Since reopening the comment period, FDA has scheduled a Food Advisory Committee (FAC) Nutrition Subcommittee meeting for April 27 and 28, 2004. The outcome of this meeting may help determine the course of action for trans fat labeling. FDA is extending the comment period to receive comments that consider the information resulting from this upcoming FAC Nutrition Subcommittee meeting specific to this ANPRM and trans fat labeling.
View this proposed rule: |
69 Fed. Reg. 19766 (April 14, 2004) (interim final rule) (to be codified at 21 C.F.R. Parts 1 and 20). The Food and Drug Administration is reopening for 30 days, on a limited set of issues, the comment period on the registration of food facilities interim final rule (IFR) that appeared in the Federal Register of October 10, 2003. The IFR requires domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA by December 12, 2003.
View this interim final rule: |
69 Fed. Reg. 19763 (April 14, 2004) (interim final rule) (to be codified at 21 C.F.R. Part 1). The Food and Drug Administration (FDA) is reopening for 30 days the comment period for FDA's prior notice interim final rule (IFR) that published in the Federal Register of October 10, 2003. The prior notice interim final rule 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 interim final rule: |
69 Fed. Reg. 19765 (April 14, 2004) (final rule) (to be codified at 21 C.F.R. Part 1). The Food and Drug Administration and Customs and Border Protection announce the availability of a plan entitled "Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes" as it relates to imported food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
View this final rule: |
69 Fed. Reg. 19872 (April 14, 2004) (notice). The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Experimental Study of Possible Footnotes and Cuing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Panel" has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995.
View this notice: |
69 Fed. Reg. 18094 (April 6, 2004) (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. Name of Committee: Science Board to the Food and Drug Administration. General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.
View this notice: |
69 Fed. Reg. 16940 (March 31, 2004) (notice). The Food and Drug Administration held a public meeting on September 22 and 23, 2003, to discuss the potential development of a comprehensive, risk-based animal feed safety system (AFSS). The AFSS is intended to describe how animal feeds (individual ingredients and mixed feeds) should be manufactured and distributed to minimize risks to animals consuming the feed and humans consuming food products from animals. This notice announces that information produced from this meeting, along with documents drafted following the meeting, are being made available for public comment and review.
View this notice: |
69 Fed. Reg. 9559 (March 1, 2004) (proposed rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration (FDA) is reopening for 45 days the comment period for an advanced notice of proposed rule making published in the Federal Register of July 11, 2003, in which FDA is requesting information and data that potentially could be used to establish new nutrient content claims about trans fatty acids (trans fat); to establish qualifying criteria for trans fat in current nutrient content claims for saturated fatty acids and cholesterol, lean and extra lean claims, and health claims that contain a message about cholesterol-raising lipids; and, in addition, to establish disclosure and disqualifying criteria to help consumers make heart-healthy food choices. Since publication of the on July 11, 2003, the Institute of Medicine of the National Academy of Science issued a report entitled "Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification." FDA is reopening the comment period to receive comments that consider the information in the report.
View this proposed rule: |
69 Fed. Reg. 8330 (February 24, 2004) (final rule) (to be codified at 21 C.F.R. Part 1). This final rule announces corrections to a prior notice of imported food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
View this final rule: |
69 Fed. Reg. 8448 (February 24, 2004) (notice). The Food and Drug Administration is announcing that a collection of information entitled "Requirements for Medicated Feed Mill License" has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995.
View this notice: |
69 Fed. Reg. 7760 (February 19, 2004) (notice). The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (52) entitled "Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora." This guidance is a revision of the guidance document 52 entitled "Microbiological Testing of Antimicrobial Drug Residues in Food," which was implemented in 1996. In this guidance, the FDA recommends a pathway approach for assessing the microbiological safety of antimicrobial drug residues in food, rather than the approach described in the 1996 version of the guidance. The FDA's decision to revise this guidance is based on new information available to the agency.
View this notice: |
69 Fed. Reg. 4851 (February 2, 2004) (final rule) (to be codified at 21 C.F.R. Part 1). The Food and Drug Administration is correcting an interim final rule that appeared in the Federal Register of October 10, 2003 (68 FR 58974). The document issued an interim 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. The document was published with some errors. This document corrects those errors.
View this http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-1592.htm: |
69 Fed. Reg. 3868 (January 27, 2004) (proposed rule) (to be codified at 21 C.F.R. Part 101). The Food and Drug Administration (FDA) is extending to February 25, 2004, the comment period for the advance notice of proposed rulemaking that appeared in the Federal Register of November 25, 2003 (68 FR 66040), in which the FDA requested comments on alternatives for regulating qualified health claims in the labeling of conventional human foods and dietary supplements. FDA also solicited comments on various other issues related to health claims and on the appropriateness and nature of dietary guidance statements on conventional foods and dietary supplement labels. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
View this proposed rule: |
69 Fed. Reg. 3588 (January 26, 2004) (notice). This notice announces a forthcoming meeting of the Transmissible Spongiform Encephalopathies Advisory Committee.
View this notice: |
69 Fed. Reg. 2146 (January 14, 2004) (notice). The Food and Drug Administration is announcing the availability of a draft compliance policy guide entitled "Guidance Levels for Radionuclides in Domestic and Imported Foods." The draft provides updated guidance levels for radionuclide activity concentration in food offered for import and makes these same guidance levels for radionuclide activity concentration applicable to food in domestic interstate commerce for the first time. The draft also expands the scope of coverage of FDA policy from food accidentally contaminated with radionuclides to food accidentally or intentionally contaminated with radionuclides. The agency is also announcing the availability of a draft supporting document entitled "Supporting Document for Guidance Levels for Radionuclides in Domestic and Imported Foods."
View this notice: |
69 Fed. Reg. 1675 (January 12, 2004) (final rule) (to be codified at 21 C.F.R. Part 1). The Food and Drug Administration is announcing the availability of a revised guidance entitled "Questions and Answers Regarding the Interim Final Rule on Registration of Food Facilities." The guidance responds to various questions raised about § 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the agency's implementing regulation, which require facilities that manufacture/process, pack, or hold food for consumption in the United States to register with FDA by December 12, 2003.
View this final rule: |
69 Fed. Reg. 930 (January 7, 2004) (notice; correction). The Food and Drug Administration is correcting a document that appeared in the Federal Register of December 12, 2003 (68 FR 69408). This document is being republished in its entirety and will read as follows: The Food and Drug Administration is announcing the availability of small entity compliance guides for the interim final rules on Registration of Food Facilities and Prior Notice of Imported Food issued under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 . Both interim final rules published in the Federal Register of October 10, 2003. These SECGs are intended to help small businesses better understand the registration and prior notice regulations.
View this notice: |
68 Fed. Reg. 65303 (November 19, 2003) (notice). The Food and Drug Administration is announcing an amendment to the notice of meeting entitled "Food Labels, Packaging, Restaurants, and Weight Management; Public Workshop." The notice published in the Federal Register of October 17, 2003. The amendment is being made to reflect that the Food and Drug Administration is requesting comments regarding the workshop. There are no other changes.
View this notice: |
68 Fed. Reg. 65168 (November 19, 2003) (notice). 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 the veterinary prescription use of dexamethasone injectable solution in dogs, cats, cattle, and horses.
View this notice: |
68 Fed. Reg. 61639 (October 29, 2003) (proposed rule) (to be codified at 21 C.F.R. Part 131). The Food and Drug Administration is reopening for ninety days the comment period for an advance notice of proposed rulemaking that announced the filing of a petition asking the agency to revoke the standards of identity for lowfat yogurt and nonfat yogurt; amend the standard of identity for yogurt in numerous respects, including incorporation of provisions for lowfat and nonfat yogurt; and amend the standard of identity for cultured milk in numerous respects, including allowing for the use of the alternate term "fermented milk." This action is being taken in response to a request for more time to submit comments to FDA.
View this proposed rule: |
68 Fed. Reg. 50795 (October 17, 2003) (notice). The Food and Drug Administration, in collaboration with the Department of Health and Human Service's Office of the Assistant Secretary for Planning and Evaluation and the Food and Drug Administration's Center for Food Safety and Applied Nutrition, is announcing a public workshop entitled "Exploring the Connections Between Weight Management and Food Labels and Packaging." The workshop is being held in response to the growing concern about obesity in the United States. It is intended to be a science workshop (i.e., nutrition, consumer science, economics, marketing and other relevant sciences) that will look at available data to identify options relating to food labeling and food packaging requirements that are relevant to consumer weight management decisions.
View this notice: |
68 Fed. Reg. 59795 (October 17, 2003) (notice). The Food and Drug Administration, Center for Food Safety and Applied Nutrition, announces its intent to award on an urgent basis, a single-source, program expansion supplement to the current cooperative agreement with the Illinois Institute of Technology for $1.1 million in fiscal year 2004. This cooperative agreement provides support for the National Center for Food Safety and Technology, which is located on Illinois Institute of Technology's Moffett Campus in Summit- Argo, Illinois. The additional funding will enable the Illinois Institute of Technology to undertake two new food contaminant mitigation projects and to continue the build-out of the biosafety level 3 laboratory that began last year.
View this notice: |
68 Fed. Reg. 59714 (October 17, 2003) (final rule) (to be codified at 21 C.F.R. Parts 111 and 310). The Food and Drug Administration is removing, in part, a final rule that required unit-dose packaging for iron-containing dietary supplement and drug products that contain 30 milligrams or more of iron per dosage unit. The Food and Drug Administration is taking this action in response to the Court's ruling in Nutritional Health Alliance v. FDA, in which the Court concluded that the Federal Food, Drug, and Cosmetic Act does not provide the Food and Drug Administration with authority to require manufacturers of iron- containing dietary supplement and drug products to use unit-dose packaging for poison prevention purposes. Today's action takes the ministerial step of removing the unit-dose packaging provisions from title 21 of the Code of Federal Regulations.
View this final rule: |
68 Fed. Reg. 65303 (November 19, 2003) (notice). The Food and Drug Administration is announcing an amendment to the notice of meeting entitled "Food Labels, Packaging, Restaurants, and Weight Management; Public Workshop." The notice published in the Federal Register of October 17, 2003. The amendment is being made to reflect that the Food and Drug Administration is requesting comments regarding the workshop. There are no other changes.
View this notice: |
68 Fed. Reg. 65168 (November 19, 2003) (notice). 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 the veterinary prescription use of dexamethasone injectable solution in dogs, cats, cattle, and horses.
View this notice: |
68 Fed. Reg. 61639 (October 29, 2003) (proposed rule) (to be codified at 21 C.F.R. Part 131). The Food and Drug Administration is reopening for ninety days the comment period for an advance notice of proposed rulemaking that announced the filing of a petition asking the agency to revoke the standards of identity for lowfat yogurt and nonfat yogurt; amend the standard of identity for yogurt in numerous respects, including incorporation of provisions for lowfat and nonfat yogurt; and amend the standard of identity for cultured milk in numerous respects, including allowing for the use of the alternate term "fermented milk." This action is being taken in response to a request for more time to submit comments to FDA.
View this proposed rule: |
68 Fed. Reg. 50795 (October 17, 2003) (notice). The Food and Drug Administration, in collaboration with the Department of Health and Human Service's Office of the Assistant Secretary for Planning and Evaluation and the Food and Drug Administration's Center for Food Safety and Applied Nutrition, is announcing a public workshop entitled "Exploring the Connections Between Weight Management and Food Labels and Packaging." The workshop is being held in response to the growing concern about obesity in the United States. It is intended to be a science workshop (i.e., nutrition, consumer science, economics, marketing and other relevant sciences) that will look at available data to identify options relating to food labeling and food packaging requirements that are relevant to consumer weight management decisions.
View this notice: |
68 Fed. Reg. 59795 (October 17, 2003) (notice). The Food and Drug Administration, Center for Food Safety and Applied Nutrition, announces its intent to award on an urgent basis, a single-source, program expansion supplement to the current cooperative agreement with the Illinois Institute of Technology for $1.1 million in fiscal year 2004. This cooperative agreement provides support for the National Center for Food Safety and Technology, which is located on Illinois Institute of Technology's Moffett Campus in Summit- Argo, Illinois. The additional funding will enable the Illinois Institute of Technology to undertake two new food contaminant mitigation projects and to continue the build-out of the biosafety level 3 laboratory that began last year.
View this notice: |
68 Fed. Reg. 59714 (October 17, 2003) (final rule) (to be codified at 21 C.F.R. Parts 111 and 310). The Food and Drug Administration is removing, in part, a final rule that required unit-dose packaging for iron-containing dietary supplement and drug products that contain 30 milligrams or more of iron per dosage unit. The Food and Drug Administration is taking this action in response to the Court's ruling in Nutritional Health Alliance v. FDA, in which the Court concluded that the Federal Food, Drug, and Cosmetic Act does not provide the Food and Drug Administration with authority to require manufacturers of iron- containing dietary supplement and drug products to use unit-dose packaging for poison prevention purposes. Today's action takes the ministerial step of removing the unit-dose packaging provisions from title 21 of the Code of Federal Regulations.
View this final rule: |
67 Fed. Reg. 43248 (June 27, 2002) (final rule). This final rule establishes that the The Food and Drug Administration is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Alpharma, Inc. The supplemental NADA provides for the administration of Type C medicated feeds containing chlortetracycline to cattle as a top dress on feed for the treatment of enteritis and pneumonia.
View this proposed rule: |
67 Fed. Reg. 12,918 (Mar. 20, 2002) (proposed rule) (to be codified at 21 C.F.R. pt. 101). This rule proposes amendments to the voluntary nutrition labeling provisions for raw fruits, vegetables, and fish. Comments on the proposed changes were due June 3, 2002.
View this proposed rule: |
CORRECTION: This proposed rule was initially published with an incorrect docket number. A correction was published and additional time provide for comments. 67 Fed. Reg. 38,913 (June 6, 2002) (correction). Comments are now due by August 20, 2002.
View this correction: |
67 Fed. Reg. 5607 (Feb. 6, 2002) (notice). This notice announces the availability of a document entitled "Guidance for Industry; Implementation of Section 755 of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2002, Pub. L. 107-76, Sec. 755 (2001) Regarding Common or Usual Names for Catfish." The Act provides that FDA may not spend any of its 2002 appropriation to allow admission of fish products labeled with the term "catfish" unless the fish are from the Ictaluridae family. This notice provides guidance as to how the FDA plans to exercise enforcement.
View this notice: |
CORRECTION: The notice was inadvertently published without the mailing address for the Dockets Management Branch. This information is provided at 67 Fed. Reg.10,922 (Mar. 11, 2002) (correction).
View this correction: |
67 Fed. Reg. 2384 (Jan. 17, 2002) (proposed rule) (to be codified at 21 C.F.R. pt. 500). This rule proposes amendments to the regulation of carcinogenic compounds used in food-producing animals. It proposes that the operational definition of the term "no residue" be deleted and that conforming amendments be made to other parts of the regulations. The prefatory comments state that the proposed amendments are in response to a legal opinion issued by the Department of Justice, Office of Legal Counsel, which concluded that the operational definition of "no residue" is not legally supportable.
View this proposed rule: |