This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
FederalRegister.gov retrieves relevant information about this document from Regulations.gov to provide users with additional context. This information is not part of the official Federal Register document.
Food and Drug Administration, HHS.
Notice; request for information.
The Food and Drug Administration (FDA, the Agency, or we) invites 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).
Submit either electronic or written comments on the request for ( printed page 88786) information by January 7, 2025 to ensure that the Agency considers your comment.
You may submit comments in the following way:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2024-N-4776 for “Export Lists for Human Food: Request for Information.” 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.
Peter Fricke, Human Foods Program, Office of International Engagement, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2307.
Under section 801(e)(4)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(e)(4)(A)), any person who exports a food, drug, animal drug, or device may request that FDA:
If we issue a written export certification within 20 days, we may then charge a fee up to $175 for each certification (see section 801(e)(4)(B) of the FD&C Act). The statute also authorizes us to issue certifications on a basis and in a form that we determine to be appropriate and expressly mentions publicly available listing as a form of certification (see section 801(e)(4)(C) of the FD&C Act).
Regarding export certification for human foods, FDA issues various types of export certificates and certification in the form of export lists. (For more information on the types of export certificates we issue for human foods, see https://www.fda.gov/food/exporting-food-products-united-states/food-export-certificates.) To request inclusion on an export list, parties can use our Export Listing Module, which can be accessed through our website at https://www.access.fda.gov/. Certification in the form of export lists is an intensive process due to both the development of a mutually acceptable listing procedure with foreign countries and then the maintenance of the export lists. FDA provides such certification to help ensure foreign market access for U.S. exporters of FDA-regulated food products. FDA export certification provides information concerning a product's regulatory status, often including information about the establishment in which the product was manufactured, packaged, prepared and/or held, based on available information at the time FDA issues the certification (including, as appropriate, attestations provided by the person seeking the export certification). In many cases, foreign governments are seeking official assurance that products exported from the United States to their countries can be marketed in the United States or that the products meet specific U.S. regulations, for example, as applicable, current good manufacturing practice regulations. A foreign government may also require export certification as part of the process to register or import a product into that country.
FDA does not currently charge firms to be included on export lists for human food, but as authorized by the FD&C Act, we are considering charging fees for our export list services to offset our costs. 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.
To better inform the continuing development of our export list program for human foods, we invite public comment on the following: ( printed page 88787)
Dated: November 4, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-26040 Filed 11-7-24; 8:45 am]
BILLING CODE 4164-01-P
9 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.