Notice2022-13071
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
June 17, 2022
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 87 Issue 117 (Friday, June 17, 2022)</title>
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[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36514-36516]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13071]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0721]
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: Fax written comments on the collection of information by July
18, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to <a href="/cdn-cgi/l/email-protection#056a6c77645a767067686c76766c6a6b456a68672b606a752b626a73"><span class="__cf_email__" data-cfemail="26494f5447795553444b4f55554f494866494b440843495608414950">[email protected]</span></a>. All
comments should be identified with the OMB control number 0910-0750.
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-45, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#1b4b495a486f7a7d7d5b7d7f7a35737368357c746d"><span class="__cf_email__" data-cfemail="92c2c0d3c1e6f3f4f4d2f4f6f3bcfafae1bcf5fde4">[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 helps to implement FDA's Accredited
Third-Party Certification Program (also referred to as the third-party
food program), established and 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 parts 1.600 through 1.725)
of Agency regulations. The regulations communicate eligibility
criteria, assessment standards, and establish procedures and
requirements
[[Page 36515]]
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 the third-party food program, 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. FDA uses
certifications issued by accredited third-party auditors/CBs in
deciding whether to admit certain imported food (both food for human
and other animals) into the United States. Under the third-party
program, FDA may grant recognition of an AB for up to 5 years from the
date of recognition. Current third-party program AB participants are
recognized for the duration from 2018 to 2023 and will need to submit
renewal of recognition applications to continue their participation.
There are approximately 200,000 foreign food (both food for human
and other 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 (21 U.S.C. 381(q)(3)). In that case, to
continue exporting food products into the United States, eligible
entities must either obtain certification from a CB accredited under
the third-party program, 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.
Participating in the third-party accreditation program helps reduce
the number of redundant audits necessary to assess compliance with food
safety requirements of the FD&C Act and applicable regulations.
Required data elements are submitted 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.
Instructions 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 eligible entities
seeking audits, certification, and/or recertification by accredited CBs
participating in the third-party program, and ABs and CBs seeking to
comply with the recognition requirements. An eligible entity is a
foreign entity in the import supply chain of food for consumption in
the United States that chooses to be subject to a food safety audit
conducted by an accredited third-party CB.
In the Federal Register of February 16, 2022, (87 FR 8846), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR part 1, subpart M Number of responses per Total annual Average burden per response \2\ Total hours
respondents respondent \2\ responses
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AB applications, renewals, notifications, 25 11.36 284 3.18..................................... 903
revocations.
CB certifications, regulatory audits and 208 147.29 30,638 0.25 (15 minutes)........................ 7,661
assessments, notifications.
CB applications for direct accreditation & 1 1 1 90....................................... 90
renewal.
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Total.................................... .............. .............. 30,923 ......................................... 8,654
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\1\ We estimate no capital costs or operating and maintenance costs for the information collection.
\2\ Figures rounded to the nearest one, one-hundred 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 annual
21 CFR part 1, subpart M recordkeepers recordkeeper records Average burden per recordkeeping \2\ Total hours
\2\
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AB documenting certification procedures; 25 426.56 10,664 0.25 (~15 minutes)....................... 2,677
maintaining applicable records.
AB establishing and updating public list of 25 1 25 52.8..................................... 1,320
CBs.
CB documenting procedures for accreditation; 208 112.72 23,446 0.35 (~20 minutes)....................... 8,228
maintaining applicable records (audits,
certifications, serious risks).
CB establishing & updating public list of 208 1.31 273 44.19.................................... 12,064
eligible entities.
Contract modification \2\.................... 7 9 63 2........................................ 126
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Total.................................... .............. .............. 34,471 ......................................... 24,415
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\1\ We estimate no capital costs, or operating and maintenance costs for the information collection.
\2\ Figures rounded to the nearest one, one-hundred as calculated based on total number of records and hours.
We include in our estimate reporting burden attributable to
required submissions, including notifications, to FDA; and
recordkeeping burden attributable to the time we assume necessary for
searching data sources, and preparing and maintaining records described
in the applicable regulations. We estimate that 25 ABs will accredit
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CBs who conduct food safety audits of foreign eligible entities that
offer food for import to the United States. We also estimate the 208
accredited CBs will participate in the third-party program. In
addition, we expect that one CB will apply and participate in the
third-party program via direct accreditation by FDA. Finally, we
attribute nominal burden to recordkeeping attendant to contractual
modifications that may be part of accreditation.
Based on a review of the information collection since last OMB
approval, we have made only nominal adjustments to our burden estimate.
Dated: June 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13071 Filed 6-16-22; 8:45 am]
BILLING CODE 4164-01-P
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