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
Title 21 published on 10-May-2017 03:43
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 106 after this date.
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.
2016-04-15; vol. 81 # 73 - Friday, April 15, 2016 81 FR 22174 - Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Guidance for Industry; Availability
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of availability. Submit either electronic or written comments on FDA guidances at any time. 21 CFR Part 106 Summary The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled “Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.” The guidance describes our current thinking on the manufacturing of exempt infant formula in relation to the requirements for CGMPs, quality control procedures, conduct of audits, and records and reports that apply to non-exempt infant formulas.
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.
2014-07-15; vol. 79 # 135 - Tuesday, July 15, 2014 79 FR 41127 - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula; Correction
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correction. Effective July 15, 2014. 21 CFR Parts 106 and 107 Summary The Food and Drug Administration (FDA or we) is correcting a final rule that appeared in the Federal Register of June 10, 2014. The final rule revised our infant formula regulations by establishing requirements for current good manufacturing practices, including audits; establishing requirements for quality factors; and amending our quality control procedures, notification, and record and reporting requirements for infant formula. We issued the final rule to provide greater protection of infants who consume infant formula products. In this document, we correct some errors that appeared in the preamble to the final rule.
2014-06-10; vol. 79 # 111 - Tuesday, June 10, 2014 79 FR 33056 - Guidance for Industry: Demonstration of the Quality Factor Requirements for “Eligible” Infant Formulas; Availability
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of availability. Submit either electronic or written comments on FDA guidances at any time. 21 CFR Part 106 Summary The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance which describes our current thinking on the quality factor requirements for eligible infant formulas, the record requirements for eligible infant formulas, and the submission of citizen petitions for eligible infant formulas.
79 FR 33057 - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This final rule is effective July 10, 2014. The compliance date for manufacturers to meet the requirements of §§ 106.96(a), 106.96(e), 106.96(i)(5), 106.100(p)(2) and 106.100(q)(2) related to quality factors for eligible infant formulas is November 12, 2015. The compliance date for the remaining provisions of this final rule is September 8, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by July 10, 2014 (see section VII, the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 106 and 107 Summary The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled “Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula” (February 10, 2014). This final rule affirms the IFR's changes to FDA's regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR.
2014-02-19; vol. 79 # 33 - Wednesday, February 19, 2014 79 FR 9412 - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula; Correction
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Interim final rule; request for comments; correction. Effective Date: This correction is effective February 19, 2014. 21 CFR Parts 106 and 107 Summary The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of February 10, 2014. The document revised our infant formula regulations to establish requirements for current good manufacturing practices, including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA took the action to improve the protection of infants who consume infant formula products. The document was published with an incorrect docket number. This document corrects that error.
2014-02-10; vol. 79 # 27 - Monday, February 10, 2014 79 FR 7609 - Draft Guidance for Industry: Demonstration of the Quality Factor Requirements for “Eligible” Infant Formulas; Availability
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of availability. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 27, 2014. 21 CFR Part 106 Summary The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled “Guidance for Industry: Demonstration of the Quality Factor Requirements for `Eligible' Infant Formulas.” The draft guidance, when finalized, will describe our current thinking on the quality factor requirements for eligible infant formulas, the record requirements for eligible infant formulas, and the submission of citizen petitions for eligible infant formulas.
79 FR 7610 - Draft Guidance for Industry; Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Availability
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of availability. Although you may comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 12, 2014. 21 CFR Part 106 Summary The Food and Drug Administration (FDA or we) is announcing the availability of the draft guidance entitled “Guidance for Industry; Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.” The draft guidance, when finalized, will describe our current thinking on the manufacturing of exempt infant formula in relation to the requirements for CGMPs, quality control procedures, conduct of audits, and records and reports that apply to nonexempt infant formulas.
79 FR 7934 - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Interim final rule; request for comments. Effective date: This interim final rule is effective July 10, 2014. Comment date: Interested persons may submit either electronic or written comments on this interim final rule by March 27, 2014. Paperwork Reduction Act date: Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 12, 2014, (see the “Paperwork Reduction Act of 1995” section of this document). The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of July 10, 2014. 21 CFR Parts 106 and 107 Summary The Food and Drug Administration (FDA, the Agency, or we) is revising our infant formula regulations to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products.
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.
