[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64925-64926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17641]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2032]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food and Cosmetic 
Export Certificate Application Process

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by September 9, 2024.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0793. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Food and Cosmetic Export Certificate Application Process

OMB Control Number 0910-0793--Revision

    This information collection helps support implementation of 
statutory and regulatory authorities governing the export of certain 
FDA-regulated products found in section 801 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 381), and in 21 CFR part 1, subpart E--
Imports and Exports, of Agency regulations. Some countries may require 
manufacturers of FDA-regulated products to provide certificates for 
products they wish to export to that country. Accordingly, firms 
exporting products from the United States often ask FDA to provide such 
a ``certificate.'' In many cases, foreign governments are seeking 
official assurance that products exported to their countries can be 
marketed in the United States, or that they meet specific U.S. 
requirements. In some cases, review of an FDA export certificate may be 
required as part of the process to register or import a product into 
another country. An export certificate generally indicates that the 
particular product is marketed in the United States or otherwise 
eligible for export and that

[[Page 64926]]

the particular manufacturer has no unresolved enforcement actions 
pending before, or taken by, FDA.
    Consistent with this authority, interested persons may request 
human food and cosmetic export certificates electronically via the 
Export Certification Application and Tracking System (eCATS) or 
Certificate Application Process (CAP), components of the FDA Industry 
Systems, or by contacting FDA for assistance. Health certificates are 
the exception and are requested via email. To facilitate the 
application process, we have eliminated paper-based forms. All 
information is currently submitted electronically using Forms FDA 
3613d, 3613e, and 3613k. The eCATS Module is Form 3613k, where 3613e is 
the Certificate of Free Sale (https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food). All 
``forms'' are electronic and part of the eCATS or CAP portal accessed 
via https://www.access.fda.gov. To view representations of the forms, 
instructions must be downloaded and are accessible through the 
following links: https://www.fda.gov/cosmetics/cosmetics-exporters/online-applications-export-certificates-cosmetics and https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food.
    While a burden associated with information collection activities 
for export certificates issued for other FDA regulated products is 
accounted for and approved under OMB control number 0910-0498, this 
collection specifically supports information collection activity 
attributable to export certificates issued for human food and cosmetic 
products. Also, because we have eliminated paper-based forms, 
respondents who require assistance with completing export certificate 
applications online may contact FDA directly by email 
([email protected]) or telephone (240-402-2307). 
Instructions for requesting export certificates for cosmetics (Form FDA 
3613d) are available online at https://www.fda.gov/cosmetics/cosmetics-exporters/online-applications-export-certificates-cosmetics and 
instructions for requesting export certificates for food (Forms FDA 
3613e and Form 3613k) are available online at https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food.
    We are revising the information collection to include a web-based 
inquiry form, Form FDA 5077, entitled ``U.S. Department of Health and 
Human Services Food and Drug Administration Export Certification 
Inquiry,'' intended to facilitate processing by cross-referencing the 
request with existing Agency data. A mockup of the proposed electronic 
form is posted to the docket to solicit public comment. For food 
products, respondents may identify facilities using their Food Facility 
Registration number, FDA Establishment Identifier number, or a Data 
Universal Numbering System number. The system uses these identifiers to 
locate and auto-populate name and address information, eliminating the 
need for users to manually enter this information and reducing the time 
to complete the application. For some applications, respondents can 
also upload product information via a spreadsheet, which reduces the 
time needed to enter product information, particularly for applications 
that include multiple products.
    Description of Respondents: The respondents to this collection of 
information are firms interested in exporting U.S.-manufactured human 
food and cosmetic products to foreign countries that require export 
certificates.
    In the Federal Register of May 15, 2024 (89 FR 42472), we published 
a 60-day notice requesting public comment on the proposed collection of 
information. Although two comments were received, neither appeared to 
be responsive to the information collection topics solicited in the 
notice, nor suggested FDA modify its burden estimates.
    We therefore estimate the burden of the collections of information 
as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                     Number of
        Type of certificate                  Form No.\2\             Number of     responses per    Total annual   Average burden per response    Total
                                                                    respondents      respondent       responses                                   hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cosmetics..........................  FDA 3613d..................              66                3             198  0.5 (30 minutes)...........        99
Food...............................  FDA 3613e, 3613k...........             454               10           4,540  0.5 (30 minutes)...........     2,270
Export Certification Inquiry.......  FDA 5077...................             520               18           9,360  0.25 (15 minutes)..........     2,340
                                                                 ---------------------------------------------------------------------------------------
    Total..........................  ...........................  ..............  ...............  ..............  ...........................     4,709
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ All forms are submitted electronically via FDA Industry Systems.

    Since our last review of the information collection, we have 
adjusted our estimate of the number of respondents downward. At the 
same time, we have increased the number of responses per respondent and 
added new Form FDA 5077. Cumulatively these activities result in an 
estimated burden increase of 2,433 hours and 9,547 responses annually.

    Dated: August 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17641 Filed 8-7-24; 8:45 am]
BILLING CODE 4164-01-P