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2017-11-16
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Best Practices for Convening a Generally Recognized as Safe Panel: Draft Guidance for Industry; Availability
Proposed Rules
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Best Practices for Convening a GRAS Panel.'' This draft guidance document is intended for any person who is responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe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 This draft guidance provides our current thinking on best practices to identify GRAS panel members who have appropriate and balanced expertise; to take steps to reduce the risk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).
82 FR 53433
https://www.govinfo.gov/app/details/FR-2017-11-16/2017-24845
2017-24845
fr16no17-16
4164-01-P
Docket No. FDA-2017-D-0085
https://www.govinfo.gov/app/details/FR-2017-11-16/2017-24845
https://www.govinfo.gov/content/pkg/FR-2017-11-16/html/2017-24845.htm
https://www.govinfo.gov/content/pkg/FR-2017-11-16/pdf/2017-24845.pdf
6 p.
53433
53438
82 FR 53433
Code of Federal Regulations
Title 21 Part 170
21 CFR Part 170
Code of Federal Regulations
Title 21 Part 570
21 CFR Part 570
Best Practices for Convening a Generally Recognized as Safe Panel: Draft Guidance for Industry; Availability; Federal Register Vol. 82, Issue
PRORULE
2017-24845
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2017-D-0085
4164-01-P
2017-24845
Notification of availability.
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).
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.
Regarding substances that would be used in human food: Paulette M. Gaynor, Center for Food Safety and Applied Nutrition (HFS-255), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1192. Regarding substances that would be used in animal food: Geoffrey K. Wong, Center for Veterinary Medicine (HFV-224), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5838. Regarding the information collection issues: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
Guidance:
Best Practices for Convening a Generally Recognized as Safe Panel
,
PRAStaff@fda.hhs.gov
http://aibmr.com/natural-products-industry-compliance-consultation/gras-generally-recognized-as-safe-safety-studies/
http://www.fda.gov/FoodGuidances
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.nationalacademies.org/coi/
https://www.accessdata.fda.gov/scripts/fdcc/?set=GRASNotices
https://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/GenerallyRecognizedasSafeGRASNotifications/ucm243845.htm
https://www.nap.edu/catalog/12598/conflict-of-interest-in-medical-research-education-and-practice
https://www.regulations.gov
Federal Register
Vol. 82, no. 220
Office of the Federal Register, National Archives and Records Administration
2017-11-16
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2017-11-16
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https://www.govinfo.gov/app/details/FR-2017-11-16
https://www.govinfo.gov/content/pkg/FR-2017-11-16/pdf/FR-2017-11-16.pdf
https://www.govinfo.gov/content/pkg/FR-2017-11-16/xml/FR-2017-11-16.xml
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