[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36514-36516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13071]


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

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.

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

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 [email protected]. 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, 
[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.

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 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.
    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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
 \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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............          34,471  .........................................          24,415
--------------------------------------------------------------------------------------------------------------------------------------------------------
 \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

[[Page 36516]]

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


