[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Notices]
[Pages 8846-8848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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.

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: 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 https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program.
    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 https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program.
    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.
                                           -------------------------------------------------------------------------------------------------------------
    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
                                           -------------------------------------------------------------------------------------------------------------
    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


