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[Federal Register Volume 89, Number 247 (Thursday, December 26, 2024)]
[Notices]
[Pages 105059-105060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30784]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-4776]

Export Lists for Human Food: Request for Information; Extension 
of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the request for information, published in the 
Federal Register of November 8, 2024. In that notice, FDA invited 
comment relating to the listing requirements of other countries and 
FDA's approach to facilitating U.S. industry compliance with these 
requirements through the issuance of export certification for human 
food products provided in the form of lists (export lists). We are 
extending the comment period to allow interested persons additional 
time to submit comments on FDA's approach.

DATES: FDA is extending the comment period announced in the notice for 
request for information published November 8, 2024 (89 FR 88785).

[[Page 105060]]

Electronic or written comments must be submitted by February 21, 2025.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 21, 2025. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

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-2024-N-4776 for ``Export Lists for Human Food: Request for 
Information.'' Received comments, those filed in a timely manner (see 
ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Lauren Ferguson Baham, Office of 
Policy, Regulations, and Information, Human Foods Program, Food and 
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2371.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 8, 2024, 
we published a notice announcing a request for information. The notice 
explained our export certification for human foods and that FDA is 
considering charging firms fees for our export list services to offset 
our costs. The notice also explained that, as of August 2024, we 
provide certification in the form of export lists that cover 19 
categories of products for six destinations: Chile, China, the European 
Union, Saudi Arabia, Taiwan, and the United Kingdom. Further, the 
notice explained that, to better inform the continuing development of 
our export list program for human foods, we invited public comment on 
the following:
     There are many different types of establishment listing 
and certification procedures for establishments that produce human food 
products. Please share your experience with other countries' 
establishment listing, certification, and registration requirements.
     FDA requires those on export lists to reapply regularly if 
they wish to remain listed. Do reapplicants experience any challenges 
with the renewal process? If you have experienced challenges, how were 
those challenges resolved?
     For those included on export lists, please describe any 
challenges you have experienced with exporting human food products 
included on the export lists.
     FDA is authorized to collect up to $175 per certification 
for each company and its human food products that FDA certifies through 
inclusion on an export list. For those that would be charged a fee, do 
you have any specific suggestions about how FDA should approach the 
implementation of fees? Please provide details relating to any 
suggestions you might have (89 FR 88785).
    The docket for public comments was scheduled to close January 7, 
2025.
    We have received several requests to extend the comment period. In 
general, the requests explain that FDA's consideration to charge fees 
for its export list services to offset costs is a significant change 
from current Agency practice that will take firms time to fully 
evaluate the impacts of the proposed changes and to provide substantive 
comment that details firms' experiences and challenges with export 
lists. The requests also note that the comment period overlaps with the 
holiday season.
    We have considered the requests and are extending the comment 
period until February 21, 2025. We believe that the extension will 
allow adequate time for interested persons to submit comments.

    Dated: December 18, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-30784 Filed 12-23-24; 8:45 am]
BILLING CODE 4164-01-P
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