Title 21 published on 2014-04-01
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
2014-05-29; vol. 79 # 103 - Thursday, May 29, 2014 79 FR 30716 - Administrative Detention of Drugs Intended for Human or Animal Use
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 30, 2014. 21 CFR Parts 1 and 16 Summary The Food and Drug Administration (FDA or the Agency) is implementing administrative detention authority with respect to drugs intended for human or animal use as authorized by amendments made to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA's administrative detention authority with respect to drugs allows FDA to better protect the integrity of the drug supply chain. Specifically, FDA is able to administratively detain drugs encountered during an inspection that an authorized FDA representative conducting an inspection has reason to believe are adulterated or misbranded. This authority is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that are believed to be adulterated or misbranded, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate.
2014-04-04; vol. 79 # 65 - Friday, April 4, 2014 79 FR 18799 - Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This final rule is effective April 4, 2014. 21 CFR Part 1 Summary The Food and Drug Administration (FDA) is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled “Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements.” This final rule affirms the IFR's change to FDA's records access as required by the FDA Food Safety Modernization Act (FSMA). Prior to the passage of FSMA, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) provided the Secretary (by delegation FDA) with access to records relating to food that FDA reasonably believes to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals. The FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to include records relating to any other article of food that FDA reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which FDA believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This final rule does not make any changes to the regulatory requirements established by the IFR. The final regulation also responds to comments submitted in response to the request for comments in the IFR.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office] .
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
United States Code U.S. Code: Title 15 - COMMERCE AND TRADE U.S. Code: Title 19 - CUSTOMS DUTIES U.S. Code: Title 21 - FOOD AND DRUGS U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE
Title 21 published on 2014-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 1 after this date.
2014-10-23; vol. 79 # 205 - Thursday, October 23, 2014 79 FR 63346 - Food and Drug Administration Food Safety Modernization Act; Public Meeting
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of public meeting. See section II, “How to Participate in the Public Meeting,” in the SUPPLEMENTARY INFORMATION section of this document for the date and time of the public meeting, closing dates for advance registration, and information on deadlines for submitting either electronic or written comments to FDA's Division of Dockets Management. 21 CFR Parts 1, 16, 112, 117, and 507 Summary The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed revisions to four rules originally proposed in 2013 to implement the FDA Food Safety Modernization Act (FSMA). In response to the comments received on these foundational FSMA proposed rules, FDA issued supplemental notices of proposed rulemaking that propose significant changes to four of the proposed rules including: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food); Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety); Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Preventive Controls for Animal Food); and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Foreign Supplier Verification Programs). The purpose of the public meeting is to solicit oral stakeholder and public comments on the new content of the supplemental proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the supplemental proposed rules.
2014-09-29; vol. 79 # 188 - Monday, September 29, 2014 79 FR 58524 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; supplemental notice of proposed rulemaking. Submit either electronic or written comments on the proposed rule by December 15, 2014 Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 15, 2014 (see the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 1, 16, and 117 Summary The Food and Drug Administration (FDA or we) is proposing to amend our 2013 proposed rule for Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food. In that 2013 proposed rule, we proposed to amend the CGMP requirements to modernize them and to add requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. We also proposed to revise certain definitions in our current regulation for Registration of Food Facilities to clarify the scope of an exemption from registration requirements for “farms” and, in so doing, to clarify which domestic and foreign facilities would be subject to the proposed requirements for hazard analysis and risk-based preventive controls for human food. We are taking this action because the extensive input we have received from public comments has led to significant changes in our current thinking on certain key provisions of these proposed rules. We are reopening the comment period only with respect to specific issues identified in this proposed rule.
79 FR 58574 - Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; supplemental notice of proposed rulemaking. Submit either electronic or written comments on the supplemental notice of proposed rulemaking by December 15, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 15, 2014 (see the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Part 1 Summary The Food and Drug Administration (FDA) is revising certain provisions of the proposed rule, issued in July 2013, on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. We are primarily revising the proposed requirements concerning compliance status review of food and foreign suppliers, hazard analysis, and supplier verification activities. We are taking this action in response to the extensive public input we have received regarding these provisions and in coordination with revisions we are concurrently making to the proposed rule on current good manufacturing practice (CGMP) and hazard analysis and risk-based preventive controls for human food. We are seeking public comment on the revised proposed FSVP regulations. We are reopening the comment period on the proposed rule only with respect to the specific provisions identified in this Federal Register document.
2014-05-29; vol. 79 # 103 - Thursday, May 29, 2014 79 FR 30716 - Administrative Detention of Drugs Intended for Human or Animal Use
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 30, 2014. 21 CFR Parts 1 and 16 Summary The Food and Drug Administration (FDA or the Agency) is implementing administrative detention authority with respect to drugs intended for human or animal use as authorized by amendments made to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA's administrative detention authority with respect to drugs allows FDA to better protect the integrity of the drug supply chain. Specifically, FDA is able to administratively detain drugs encountered during an inspection that an authorized FDA representative conducting an inspection has reason to believe are adulterated or misbranded. This authority is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that are believed to be adulterated or misbranded, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate.
2014-05-23; vol. 79 # 100 - Friday, May 23, 2014 79 FR 29699 - Sanitary Transportation of Human and Animal Food; Extension of Comment Period
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; Extension of Comment Period. FDA is extending the comment period on the proposed rule published February 5, 2014 (79 FR 7005), and its information collection provisions. Submit either electronic or written comments on the proposed rule and the information collection by July 30, 2014. 21 CFR Part 1 Summary The Food and Drug Administration (FDA or we) is extending the comment period for the notice of proposed rulemaking that appeared in the Federal Register of February 5, 2014, entitled “Sanitary Transportation of Human and Animal Food” and its information collection provisions. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.
2014-05-06; vol. 79 # 87 - Tuesday, May 6, 2014 79 FR 25758 - Administrative Destruction of Certain Drugs Refused Admission to the United States
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by July 7, 2014. 21 CFR Part 1 Summary The Food and Drug Administration (FDA or Agency) is proposing a regulation to implement its authority to destroy a drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States under the Federal Food, Drug, and Cosmetic Act (FD&C Act), by providing to the owner or consignee notice and an opportunity to appear and introduce testimony to the Agency prior to the destruction. The proposed regulation is authorized by amendments made to the FD&C Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). Once finalized, this proposed regulation will allow FDA to better protect the public health by providing an administrative process for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain.
2014-04-04; vol. 79 # 65 - Friday, April 4, 2014 79 FR 18799 - Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This final rule is effective April 4, 2014. 21 CFR Part 1 Summary The Food and Drug Administration (FDA) is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled “Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements.” This final rule affirms the IFR's change to FDA's records access as required by the FDA Food Safety Modernization Act (FSMA). Prior to the passage of FSMA, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) provided the Secretary (by delegation FDA) with access to records relating to food that FDA reasonably believes to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals. The FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to include records relating to any other article of food that FDA reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which FDA believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This final rule does not make any changes to the regulatory requirements established by the IFR. The final regulation also responds to comments submitted in response to the request for comments in the IFR.
79 FR 18866 - Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of availability. Submit either electronic or written comments on FDA guidances at any time. 21 CFR Part 1 Summary The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled “FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act.” The guidance provides updated information pertaining to FDA's authority to access and copy records relating to food. It is a revision of FDA's November 2005 guidance entitled “Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Final Guidance.”
79 FR 18867 - Guidance for Industry on What You Need To Know About Establishment, Maintenance, and Availability of Records—Small Entity Compliance Guide; Availability
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification. Submit either electronic or written comments on FDA guidances at any time. 21 CFR Part 1 Summary The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “What You Need To Know About Establishment, Maintenance, and Availability of Records—Small Entity Compliance Guide” (SECG), which updates an earlier guidance of the same title. Previously, this guidance restated the legal requirements of FDA's maintenance and establishment of records regulation and served as that regulation's SECG. Because the FDA Food Safety Modernization Act (FSMA) amended FDA's maintenance and establishment of records regulation, FDA issued an interim final rule (IFR) amending certain regulations to be consistent with the changes. Accordingly, FDA is revising this guidance to help any entity comply with FDA's maintenance and establishment of records requirements, including the amendments to these requirements made by the IFR as finalized. This guidance continues to serve as FDA's SECG.
