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 570 after this date.
2017-11-16; vol. 82 # 220 - Thursday, November 16, 2017 82 FR 53433 - Best Practices for Convening a Generally Recognized as Safe Panel: Draft Guidance for Industry; Availability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you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we issue the final version of the guidance, submit either electronic or written comments by May 15, 2018. For comments related to the collection of information provisions in this draft guidance, submit either electronic or written comments by January 16, 2018. 21 CFR Parts 170 and 570 Summary The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled “Best Practices for Convening a GRAS Panel.” This draft guidance document is intended for any person who is responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) when that person convenes a panel of experts (“GRAS panel”) to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human food or animal food. This draft guidance provides our current thinking on best practices to identify GRAS panel members who have appropriate and balanced expertise; to take steps to reduce the risk that bias (or the appearance of bias) will affect the credibility of the GRAS panel's output (often called a “GRAS panel report”), including the assessment of potential GRAS panel members for conflict of interest and the appearance of conflict of interest; and to limit the data and information provided to a GRAS panel to public information ( e.g., by not providing the GRAS panel with information such as trade secret information).
2016-09-08; vol. 81 # 174 - Thursday, September 8, 2016 81 FR - Substances Generally Recognized as Safe
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration 21 CFR Parts 20, 25, 170, 184, 186, and 570 Summary
2016-08-17; vol. 81 # 159 - Wednesday, August 17, 2016 81 FR 54960 - Substances Generally Recognized as Safe
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 17, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by October 17, 2016 (see section XXIX, the “Paperwork Reduction Act of 1995” section of this document). 21 CFR Parts 20, 25, 170, 184, 186, and 570 Summary The Food and Drug Administration (FDA or we) is issuing a final rule that amends and clarifies the criteria in our regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the substance is generally recognized as safe (GRAS) under the conditions of its intended use. We also are amending our regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use. The clarified criteria for GRAS status should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act, and the notification procedure will enable stakeholders to be aware of whether we have questioned the basis of a conclusion of GRAS status.
