Notice2022-03306
Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications
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Published
February 16, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for the accreditation of third-party certification bodies to conduct food safety audits and issue certifications.
Full Text
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<title>Federal Register, Volume 87 Issue 32 (Wednesday, February 16, 2022)</title>
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[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Notices]
[Pages 8846-8848]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03306]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0721]
Agency Information Collection Activities; Proposed Collection;
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection requirements for the
accreditation of third-party certification bodies to conduct food
safety audits and issue certifications.
DATES: Submit either electronic or written comments on the collection
of information by April 18, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 18, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 18, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2019-N-0721 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Accreditation of Third-Party
Certification Bodies to Conduct Food Safety Audits and Issue
Certifications.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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.'' The Agency will
review this copy, including the claimed confidential information, in
its 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit
[[Page 8847]]
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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: 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,
<a href="/cdn-cgi/l/email-protection#c797958694b3a6a1a187a1a3a6e9afafb4e9a0a8b1"><span class="__cf_email__" data-cfemail="3a6a687b694e5b5c5c7a5c5e5b14525249145d554c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 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.
We estimate the burden of this collection of information as
follows:
[[Page 8848]]
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 25 1 25 52.8........................................ 1,320
of CBs.
CB documenting procedures for 208 112.72 23,446 0.35 (~20 minutes).......................... 8,228
accreditation; 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
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: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03306 Filed 2-15-22; 8:45 am]
BILLING CODE 4164-01-P
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