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Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Draft Guidance for Industry; Availability

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Refusal of Inspection by a Foreign Food Establishment or Foreign Government.” This draft guidance, when finalized, will provide information for foreign food establishments subject to our inspection, as well as foreign governments, on when we may consider that a foreign food establishment or a government of a foreign country has refused to permit an inspection by us as provided in the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES:

Submit either electronic or written comments on the draft guidance by February 26, 2018 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance.

ADDRESSES:

You may submit comments on any guidance at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2017-D-6528 for “Refusal of Inspection by a Foreign Food Establishment or Foreign Government.” 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.

  • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states Start Printed Page 58411“THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

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.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

Submit written requests for single copies of the draft guidance to the Compliance Policy Staff/Office of Compliance, Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Mischelle B. Ledet, Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-701-5986, or Eric Nelson, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5642, or Tyler Scandalios, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857, 240-402-4552.

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SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a draft guidance for industry entitled “Refusal of Inspection by a Foreign Food Establishment or Foreign Government.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of the FDA on this topic. 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. The guidance is not subject to Executive Order 12866.

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4, 2011, amended the FD&C Act to expand and enhance our ability to ensure that imported food products meet U.S. standards and are safe for consumers. Among the FSMA changes to the FD&C Act, we now must refuse admission of a food into the United States if it is from a foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary of Health and Human Services, upon request, to inspect such factory, warehouse, or other establishment (section 807(b) of the FD&C Act (21 U.S.C. 384c(b))). In addition, the FD&C Act, at section 807(b), states that an owner, operator, or agent in charge is considered to have refused an inspection if the owner, operator, or agent in charge does not permit an inspection of a factory, warehouse, or other establishment during the 24-hour period after we submit an inspection request, or after such other time period, as agreed upon by FDA and the foreign factory, warehouse, or other establishment.

This draft guidance, when finalized, will provide information for foreign food establishments subject to our inspection, as well as foreign governments, on when we may consider that a foreign food establishment or a government of a foreign country has refused to permit an inspection by us as provided in section 807(b) of the FD&C Act.

II. Electronic Access

Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/​FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.

Start Signature

Dated: December 6, 2017.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2017-26692 Filed 12-11-17; 8:45 am]

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