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Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for FDA staff entitled “FDA Oversight of Food Products Covered by Systems Recognition Arrangements.” This draft guidance provides recommendations related to the FDA's regulatory oversight activities for food products imported from countries whose food safety systems the FDA has recognized in Systems Recognition Arrangements (SRAs).
Submit either electronic or written comments on the draft guidance by September 10, 2021 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2019-D-1997 for “FDA Oversight of Food Products Covered by Systems Recognition Arrangements; Draft Guidance for FDA Staff.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for a single hard copy of the draft guidance entitled “FDA Oversight of Food Products Covered by Systems Recognition Arrangements” to the Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element Building, Rm. 4148, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.
Marla Hallacy, Office of Regulatory Affairs, Division of Operational Policy, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 240-402-6674.
FDA is announcing the availability of a draft guidance for FDA staff entitled “FDA Oversight of Food Products Covered by Systems Recognition Arrangements; Draft Guidance for FDA Staff.” The draft guidance is part of FDA's larger effort to take a risk-based approach to food safety to include ensuring the safety of imported food, consistent with the FDA Food Safety Modernization Act. The guidance covers FDA's regulatory oversight activities for food products covered by SRAs between FDA and its foreign regulatory counterparts. Currently, the FDA has signed SRAs with food safety agencies in Australia, Canada, and New Zealand.
The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the topic of Systems Recognition Arrangement implementation. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.
FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.regulations.gov.
Dated: July 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14789 Filed 7-9-21; 8:45 am]
BILLING CODE 4164-01-P