Notice2025-18814
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) 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.
Full Text
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<title>Federal Register, Volume 90 Issue 186 (Monday, September 29, 2025)</title>
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[Federal Register Volume 90, Number 186 (Monday, September 29, 2025)]
[Notices]
[Pages 46602-46603]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18814]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5579]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Accreditation of
Third-Party Certification Bodies To Conduct Food Safety Audits and
Issue Certifications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) 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 October 29, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 0910-0750.'' Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#94c4c6d5c7e0f5f2f2d4f2f0f5bafcfce7baf3fbe2"><span class="__cf_email__" data-cfemail="7e2e2c3f2d0a1f18183e181a1f5016160d50191108">[email protected]</span></a>.
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.
Accreditation of Third-Party Certification Bodies To Conduct Food
Safety Audits and Issue Certifications--21 CFR Part 1, Subpart M
OMB Control Number 0910-0750--Extension
This information collection supports FDA's Accredited Third-Party
Certification Program (also referred to as the third-party food program
or TPP), administered under section 808 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 384d), and codified in 21 CFR part
1, subpart M (21 CFR 1.600 through 1.725) of Agency regulations. The
regulation communicates eligibility criteria, assessment standards, and
establishes procedures and requirements for participation. For more
information visit our website at <a href="https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program">https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program</a>.
Under TPP, accreditation bodies (ABs) apply to FDA for recognition.
Recognized ABs accredit third-party certification bodies (CBs) under
the program, except in limited circumstances. The accredited CBs
conduct food safety audits and issue food or facility certifications to
eligible foreign entities. Section 808(c)(2)(B) of the FD&C Act
specifies that FDA uses certifications issued by accredited CBs under
TPP in deciding whether to admit certain imported food (both food for
human and food for animals) into the United States that we have
determined poses a food safety risk under section 801(q) of the FD&C
Act (21 U.S.C. 381(q)) and in deciding whether an importer is eligible
to participate in a program for expedited review and entry under
section 806 of the FD&C Act (21 U.S.C. 384b). Under TPP, FDA may grant
recognition of an AB for up to 5 years from the date of recognition.
There are current AB participants that are recognized through fiscal
year 2027 or 2028 and will need to submit renewal of recognition
applications to continue their participation. Specific requirements and
procedures are found in 21 CFR part 1, subpart M.
There are approximately 200,000 foreign food (both food for human
and food for animals) exporters who offer their food products for
import into the United States. These foreign food exporters include
approximately 130,000 food production facilities and approximately
71,000 farms. A proportion of these foreign food exporters may offer
food subject to mandatory certification requirements under section
801(q)(3) of the FD&C Act. In that case, to continue importing food
products into the United States, eligible entities must either obtain
certification from a CB accredited under TPP, or obtain certification
from a foreign government designated by FDA. We assume in any given
year, 75 foreign food exporters will be subject to requirements in
section 801(q) of the FD&C Act.
Use of accredited CBs and food and facility certifications issued
under TPP helps reduce the number of redundant audits necessary to
assess compliance with food safety requirements of the FD&C Act and
applicable regulations. We have developed Forms FDA 3997 and FDA 3997a
to enable respondents to submit required data elements using FDA's
Unified Registration Listing System (FURLS), an electronic portal
(Forms FDA 3997 for ABs and 3997a for CBs) that enables respondents to
complete data fields and provide information to FDA electronically. The
AB and CB portals provide a standardized format for entering
information, prompting respondents for input, and facilitating FDA's
review of the submittal. Respondents are subject to user fees for
application, renewal, and annual fees, as set forth in 21 CFR 1.700
through 1.725. The user fee rates are calculated each fiscal year and
published in the Federal Register before the start of a new fiscal
year. Electronic portal instructions and user fee information may be
accessed at <a href="https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program">https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program</a>.
Respondents to the collection of information are the accredited CBs
that conduct audits and issue certifications to eligible entities, the
ABs and CBs seeking to participate in TPP, and the recognized ABs and
accredited CBs complying with the TPP requirements. An accredited CB is
a foreign government, agency of a foreign government, foreign
cooperative, or any other third party that a recognized AB (or, in the
case of direct accreditation, FDA) has determined meets the applicable
requirements of TPP and is accredited to conduct food safety audits and
to issue food or facility certifications to eligible entities. An AB is
an authority, such as a private third-
[[Page 46603]]
party, foreign government, or foreign agency, that performs
accreditation of CBs. A recognized AB is an AB that FDA has determined
meets the applicable requirements of TPP and is authorized to accredit
CBs under TPP.
In the Federal Register on June 27, 2025 (90 FR 27625), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total
21 CFR Part 1; Subpart M Number of responses per annual Average burden per response Total
respondents respondent \2\ responses \2\ hours
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AB applications, applications 25 11.36 284 3.18........................ 903
for renewals, notifications,
and revocations.
CB certifications, regulatory 208 147.30 30,638 0.25 (15 minutes)........... 7,660
audits and assessments,
notifications..
CB applications for direct 1 1 1 90.......................... 90
accreditation & renewal.
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Total....................... ........... .............. 30,923 ............................ 8,653
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\1\ There are no capital costs or operating and maintenance costs associated with annual reporting.
\2\ Figures rounded to nearest 1/100th as calculated based on total number of records and hours.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Number of records per Total Average burden per Total
21 CFR part 1; subpart M recordkeepers recordkeeper annual recordkeeping \2\ hours
\2\ records
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AB documenting procedures for 25 426.56 10,664 0.25 (15 minutes).......... 2,666
accreditation; maintaining
applicable records.
AB establishing and updating 25 1 25 52.8....................... 1,320
public list of CBs.
CB documenting certification 208 113.04 23,512 0.35 (~20 minutes)......... 8,229
procedures; maintaining
applicable records (audits,
certifications, serious risks).
CB establishing and updating 208 1.31 272 44.19...................... 12,020
public list of eligible
entities.
Contract modification.......... 7 9 63 2.......................... 126
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Total...................... .............. ............... 34,536 ........................... 24,361
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\1\ There are no capital or operating and maintenance costs associated with the annual recordkeeping burden.
\2\ Figures rounded to the nearest 1/100th as calculated based on total number of records and hours.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. However, a miscalculation in the burden estimate was
identified during a review of the prior renewal and has been corrected.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18814 Filed 9-26-25; 8:45 am]
BILLING CODE 4164-01-P
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