2024-06118. Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Extension of Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of availability; extension of comment period.

SUMMARY:

The Food and Drug Administration (FDA, we, or the Agency) is extending the comment period for two chapters of a multichapter draft guidance entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry,” which were announced in the Federal Register of September 27, 2023. The relevant draft chapters are entitled “Chapter 11— Food Allergen Program” and “Chapter 16—Acidified Foods.” We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments before FDA begins work on the final guidance.

DATES:

FDA is extending the comment period on our draft guidance published September 27, 2023 (88 FR 66457). Submit either electronic or written comments by May 24, 2024, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final guidance.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–2016–D–2343 for “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry.” 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.

• 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 “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our 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.govinfo.gov/​content/​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, 240–402–7500.

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

FOR FURTHER INFORMATION CONTACT:

Linda Kahl, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–2784.

SUPPLEMENTARY INFORMATION:

In the Federal Register of September 27, 2023 (88 FR 66457), we published a notice announcing the availability of two chapters of a multichapter draft guidance entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food.” These draft chapters are entitled “Chapter 11—Food Allergen Program” and “Chapter 16—Acidified Foods.” The notice of availability opened a docket with a 180-day comment period, to close on March 25, 2024.

We have received a request to extend the comment period for the two draft guidance chapters. The request conveys that additional time would be helpful for stakeholders to fully evaluate the chapters and develop meaningful comments. We have considered the request and have concluded that an extension of the comment period by 60 days, until May 24, 2024, is appropriate. We believe that the extension will allow adequate time for interested persons to submit comments without significantly delaying the final guidance.

Dated: March 19, 2024.

Kimberlee Trzeciak,

Deputy Commissioner for Policy, Legislation, and International Affairs.