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 21 - FOOD AND DRUGS U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE
Title 21 published on 09-Jun-2018 03:51
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 211 after this date.
2018-05-14; vol. 83 # 93 - Monday, May 14, 2018 83 FR 22193 - The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of availability. The announcement of the guidance is published in the Federal Register on May 14, 2018. 21 CFR Parts 1, 11, 16, 106, 110, 111, 112, 114, 117, 120, 123, 129, 179, 211, and 507 Summary The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled “The FDA Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need to Know About the Food and Drug Administration Regulation—Small Entity Compliance Guide.” The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled “The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification for Certain Provisions of Four Implementing Rules.”
2018-01-05; vol. 83 # 4 - Friday, January 5, 2018 83 FR 598 - Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs; Guidance for Industry; Availability
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of availability. The announcement of the guidance is published in the Federal Register on January 5, 2018. 21 CFR Parts 1, 11, 16, 106, 110, 111, 112, 114, 117, 120, 123, 129, 179, 211, and 507 Summary The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled “Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs.” This guidance states agency compliance policy regarding certain entities and/or activities related to the “farm” definition, written assurances, food contact substances, and human food by-products for use as animal food.
2016-11-18; vol. 81 # 223 - Friday, November 18, 2016 81 FR 81685 - Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective January 17, 2017. See section V of this document for the compliance date of this final rule. 21 CFR Parts 201 and 211 Summary The Food and Drug Administration (FDA or the Agency) is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements. These requirements are intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container. FDA is also revising an existing regulation that conditionally exempts certain medical gases from certain otherwise-applicable labeling requirements in order to add oxygen and nitrogen to the list of gases subject to the exemption, and to remove cyclopropane and ethylene from the list.
2016-08-24; vol. 81 # 164 - Wednesday, August 24, 2016 81 FR 57784 - The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; extension and clarification of compliance dates for certain provisions. This final rule is effective August 24, 2016. See sections III.C, IV.A.2, IV.B, and V through VIII for the extended compliance dates. 21 CFR Parts 1, 11, 16, 106, 110, 111, 112, 114, 117, 120, 123, 129, 179, 211, and 507 Summary The Food and Drug Administration (FDA or we) is extending the dates for compliance with certain provisions in four final rules. We are extending the compliance dates to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. In addition, we are clarifying certain compliance dates in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule.
2016-01-25; vol. 81 # 15 - Monday, January 25, 2016 81 FR 3956 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Correction
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correction. Effective: January 26, 2016. 21 CFR Parts 1, 11, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 Summary The Food and Drug Administration (FDA or we) is correcting a final rule that published in the Federal Register of September 17, 2015. That final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That final rule also revised certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for “farms.” The final rule published with some editorial and inadvertent errors. This document corrects those errors.
2015-11-18; vol. 80 # 222 - Wednesday, November 18, 2015 80 FR 71934 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food Establishments
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; clarification of compliance date for certain food establishments. The compliance date under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (published on September 17, 2015 at 80 FR 55908) for grade “A” milk and milk products covered by NCIMS under the PMO is September 17, 2018. 21 CFR Parts 1, 11, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 Summary The Food and Drug Administration (FDA or we) is clarifying the compliance date that we provided for certain food establishments subject to a final rule that published in the Federal Register of September 17, 2015. Among other things, that final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. We are taking this action in response to requests for clarification of the compliance date for facilities that manufacture, process, pack, or hold grade “A” milk or milk products and that are regulated under the National Conference on Interstate Milk Shipments (NCIMS) system.
2015-09-22; vol. 80 # 183 - Tuesday, September 22, 2015 80 FR 57136 - The Food and Drug Administration Food Safety Modernization Act: Final Rules To Establish Requirements for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal Food; Public Meeting
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of public meeting. See section III, “How to Participate in the Public Meeting” in the SUPPLEMENTARY INFORMATION section of this document for dates and times of the public meeting, closing dates for advance registration, and requesting special accommodations due to disability. 21 CFR Parts 1, 11, 16, 106, 110, 114, 117, 120, 123, 129, 179, 211, 225, 500, 507, and 579 Summary The Food and Drug Administration (FDA or we) is announcing a public meeting entitled “FDA Food Safety Modernization Act: Final Rules to Establish Requirements for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal Food.” The public meeting will provide interested persons an opportunity to discuss the final rules for current good manufacturing practice, hazard analysis, and risk-based preventive controls for human and animal food (the preventive controls final rules) and FDA's comprehensive planning effort for the next phase of the FDA Food Safety Modernization Act (FSMA) implementation, which involves putting in place the new public health prevention measures and the risk-based industry oversight framework that is at the core of FSMA. The purpose of the public meeting is to brief stakeholders and interested persons on the key components of the preventive controls final rules, respond to questions, and discuss the next phase of FSMA implementation with respect to human and animal food preventive controls requirements.
2015-09-17; vol. 80 # 180 - Thursday, September 17, 2015 80 FR 55908 - Current Good Manufacturing Practice, 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 Final rule. This rule is effective November 16, 2015, except for the amendment to part 110 in instruction 13, which is effective September 17, 2018 and paragraph (2) of the definition of “qualified auditor” in § 117.3, and §§ 117.5(k)(2), 117.8, 117.405(a)(2), 117.405(c), 117.410(d)(2)(ii), 117.430(d), 117.435(d), 117.475(c)(2) and 117.475(c)(13). FDA will publish a document in the Federal Register announcing the effective dates of paragraph (2) of the definition of “qualified auditor” in § 117.3, and §§ 117.5(k)(2), 117.8, 117.405(a)(2), 117.405(c), 117.410(d)(2)(ii), 117.430(d), 117.435(d), 117.475(c)(2), and 117.475(c)(13). See section LVI for the compliance dates. 21 CFR Parts 1, 11, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 Summary The Food and Drug Administration (FDA or we) is amending our regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food in two fundamental ways. First, we are modernizing the long-standing current good manufacturing practice requirements. Second, we are adding requirements for domestic and foreign facilities that are subject to our regulation for Registration of Food Facilities to establish and implement hazard analysis and risk-based preventive controls for human food. We also are revising certain definitions in our regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided for “farms” and, in so doing, to clarify which domestic and foreign facilities are subject to the requirements for hazard analysis and risk-based preventive controls for human food. We are taking this action as part of our announced initiative to revisit the current good manufacturing practice requirements since they were last revised in 1986 and to implement new statutory provisions in the FDA Food Safety Modernization Act. The rule is intended to build a food safety system for the future that makes modern, science- and risk-based preventive controls the norm across all sectors of the food system.
2013-11-20; vol. 78 # 224 - Wednesday, November 20, 2013 78 FR 69604 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Periods
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; extension of comment period for the proposed rule and for its information collection provisions. The FDA is extending the comment period for the proposed rule referenced in the Summary. Submit either electronic or written comments on the notice of proposed rulemaking by November 22, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by November 22, 2013 (see the “Paperwork Reduction Act of 1995” section). 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 Summary The Food and Drug Administration (FDA) is extending the comment period for the notice of proposed rulemaking that appeared in the Federal Register of January 16, 2013 (78 FR 3646), entitled “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” and its information collection provisions.
2013-08-09; vol. 78 # 154 - Friday, August 9, 2013 78 FR 48636 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Periods
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; extension of comment period for the proposed rule and for its information collection provisions. The FDA is extending the comment period on the above proposed rule. Submit either electronic or written comments on the proposed rule by November 15, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by November 15, 2013 (see the “Paperwork Reduction Act of 1995” section). 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 Summary 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.
2013-04-26; vol. 78 # 81 - Friday, April 26, 2013 78 FR 24691 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Periods
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; extension of comment periods. The comment period for the proposed rule published January 16, 2013, at 78 FR 3646, is extended. In addition, the comment period for the information collection issues in the proposed rule, extended February 19, 2013, at 78 FR 11611, is further extended. Submit either electronic or written comments on the proposed rule by September 16, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 16, 2013 (see the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 Summary 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.
2013-03-20; vol. 78 # 54 - Wednesday, March 20, 2013 78 FR 17142 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Correction
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; correction. 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 Summary The Food and Drug Administration (FDA or we) is correcting a proposed rule that published in the Federal Register of January 16, 2013. That proposed rule would amend our regulation for current good manufacturing practice in manufacturing, packing, or holding human food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That proposed rule also would revise certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for “farms.” We proposed these actions as part of our announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The document published with several typographical errors, stylistic errors (such as incorrect indentation of bulleted paragraphs and a gap in the sequential numbering of tables), and a mistake in the date of a reference. The document also published with an Appendix in which all references are numbered incorrectly. This document corrects those errors.
2013-02-19; vol. 78 # 33 - Tuesday, February 19, 2013 78 FR 11611 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Period for Information Collection Provisions
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; extension of comment period for information collection provisions. The comment period for the proposed rule published January 16, 2013 (78 FR 3646), is extended. Submit either electronic or written comments by May 16, 2013. 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 Summary The Food and Drug Administration (FDA or “we”) is extending the comment period for the information collection related to the proposed rule on “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. In the preamble to the proposed rule, FDA requested comments on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the information collection provisions associated with the rule.
2013-02-13; vol. 78 # 30 - Wednesday, February 13, 2013 78 FR 10107 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; 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 dates and times of the Chicago, IL and Portland, OR public meetings, 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, 106, 110, 112, 114, 117, 120, 123, 129, 179, and 211 Summary The Food and Drug Administration (FDA) is providing public meeting registration information for two FSMA related public meetings announced in the January 31, 2013, Federal Register . These public meetings will be held along with the February 28 to March 1, 2013, Washington, DC public meeting to discuss the proposed rules to establish standards for the growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule) and for current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the preventive controls proposed rule). These proposed rules are the first of several proposed rules that would establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act (FSMA). The purpose of the public meetings 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.
2013-01-31; vol. 78 # 21 - Thursday, January 31, 2013 78 FR 6762 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; 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 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, 106, 110, 112, 114, 117, 120, 123, 129, 179, and 211 Summary The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed rules to establish standards for the growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule) and for current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the preventive controls proposed rule), which are the first of several proposed rules that would establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act (FSMA). 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.
2013-01-16; vol. 78 # 11 - Wednesday, January 16, 2013 78 FR 3646 - 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. Submit either electronic or written comments on the proposed rule by May 16, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 15, 2013, (see the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 Summary The Food and Drug Administration (FDA) is proposing to amend its regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. FDA also is proposing to revise certain definitions in FDA's current regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for “farms.” FDA is taking this action as part of its announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The proposed rule is intended to build a food safety system for the future that makes modern, science-, and risk-based preventive controls the norm across all sectors of the food system.
2012-03-20; vol. 77 # 54 - Tuesday, March 20, 2012 77 FR 16158 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This final rule is effective on March 20, 2013, except for the amendment adding § 211.122(g)(4), which is effective April 19, 2012. 21 CFR Part 211 Summary The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. FDA is also permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. This action is intended to protect consumers from labeling errors more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labeling unlikely to reach or adversely affect consumers. This action is also intended to permit manufacturers to use a broader range of error prevention and labeling control techniques than permitted by current CGMPs.
