Title 21 published on 2013-04-01
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.
The Food and Drug Administration (FDA) is issuing a final rule that adopts, without change, the interim final rule (IFR) entitled “Information Required in Prior Notice of Imported Food” that published in the Federal Register (76 FR 25542; May 5, 2011) (2011 IFR). This final rule adopts the IFR's requirement of an additional element of information in a prior notice of imported food, specifically that a person submitting prior notice of imported food, including food for animals, must report the name of any country to which the article has been refused entry.
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.
§ 1333 - Labeling; requirements; conspicuous statement
§ 1453 - Requirements of labeling; placement, form, and contents of statement of quantity; supplemental statement of quantity
§ 1454 - Rules and regulations
§ 1455 - Procedure for promulgation of regulations
§ 4402 - Smokeless tobacco warning
§ 1490 - General orders
§ 1491 - Unclaimed merchandise; disposition of forfeited distilled spirits, wines and malt liquor
§ 321 - Definitions; generally
§ 331 - Prohibited acts
§ 333 - Penalties
§ 334 - Seizure
§ 335a - Debarment, temporary denial of approval, and suspension
§ 343 - Misbranded food
§ 350c - Maintenance and inspection of records
§ 350d - Registration of food facilities
§ 352 - Misbranded drugs and devices
§ 355 - New drugs
§ 360b - New animal drugs
§ 362 - Misbranded cosmetics
§ 371 - Regulations and hearings
§ 374 - Inspection
§ 381 - Imports and exports
§ 382 - Exports of certain unapproved products
§ 387 - Definitions
§ 387a - FDA authority over tobacco products
§ 387c - Misbranded tobacco products
§ 393 - Food and Drug Administration
§ 216 - Regulations
§ 241 - Research and investigations generally
§ 243 - General grant of authority for cooperation
§ 262 - Regulation of biological products
§ 264 - Regulations to control communicable diseases
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 1 after this date.
The Food and Drug Administration (FDA or we) is announcing a public meeting to discuss two proposed rules aimed at strengthening assurances that imported food meets the same safety standards as food produced domestically. The Foreign Supplier Verification Programs (FSVP) proposal establishes requirements for importers to verify that their foreign suppliers are implementing the modern, prevention-oriented food safety practices called for by the Food Safety Modernization Act (FSMA) and achieving the same level of food safety as domestic growers and processors. The second proposed rule on the Accreditation of Third-Party Auditors/Certification Bodies would strengthen the quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies and importers currently rely to help manage the safety of their global food supply chains. The purpose of the public meeting is to solicit oral stakeholder and public comments on the 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 proposed rules.
The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,” that appeared in the Federal Register of January 16, 2013. We are taking this action to allow interested persons an opportunity to consider the interrelationships between this proposal and the two proposals announced in July 2013 on the Foreign Supplier Verification Program and on Accreditation of Third-Party Auditors/Certification Bodies. 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.
The Food and Drug Administration (FDA) is proposing to adopt regulations on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. The proposed regulations would require importers to help ensure that food imported into the United States is produced in compliance with processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under the hazard analysis and risk-based preventive controls and standards for produce safety sections of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. We are proposing these regulations in accordance with the FDA Food Safety Modernization Act (FSMA). The proposed regulations would help ensure that imported food is produced in a manner consistent with U.S. standards.
The Food and Drug Administration (FDA) is amending its regulations to provide for accreditation of third-party auditors/certification bodies to conduct food safety audits of foreign food entities, including registered foreign food facilities, and to issue food and facility certifications, under the FDA Food Safety Modernization Act (FSMA). Use of accredited third-party auditors/certification bodies and food and facility certifications will help FDA prevent potentially harmful food from reaching U.S. consumers and thereby improve the safety of the U.S. food supply. FDA also expects that these regulations will increase efficiency by reducing the number of redundant food safety audits.
The Food and Drug Administration (FDA) is proposing a regulation to implement 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). Once the applicable regulation is finalized, FDA's administrative detention authority with respect to drugs will allow FDA to better protect the integrity of the drug supply chain. Specifically, FDA will be able to administratively detain drugs encountered during an inspection that an officer or employee 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.
The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” that appeared in the Federal Register of January 16, 2013. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the proposed rule. 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.