[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4607-4609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01796]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5225]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Foreign Supplier Verification Programs for Food 
Importers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 the information collection 
requirements associated with our Foreign Supplier Verification Programs 
for Food Importers.

DATES: Submit either electronic or written comments on the collection 
of information by March 29, 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 March 29, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 29, 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-2017-D-5225 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Foreign Supplier Verification 
Programs for Food Importers.'' 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

[[Page 4608]]

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 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.

Foreign Supplier Verification Programs (FSVP) for Food Importers--21 
CFR Part 1, Subpart L

OMB Control Number 0910-0752--Extension

    This information collection supports FDA regulations in 21 CFR part 
1, subpart L (21 CFR 1.500 through 1.514), which help to implement 
section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 384a). Section 805 authorizes the Agency's FSVP and establishes 
requirements applicable to imported food. Respondents to the 
information collection are importers, as defined in section 805(a)(1) 
of the FD&C Act. The regulations are intended to provide verification 
that imported food is produced in compliance with statutory 
requirements that include the implementation of appropriate risk-based 
preventive controls. The regulations also establish that importers of 
foods must develop, maintain, and follow an FSVP that provides adequate 
assurances a foreign supplier is producing the food in compliance with 
processes and procedures that provide at least the same level of public 
health protection as those required under section 418 of the FD&C Act 
(21 U.S.C. 350g) (regarding hazard analysis and risk-based preventive 
controls for certain foods) or 419 (21 U.S.C. 350h) (regarding 
standards for produce safety), if either is applicable, and the 
implementing regulations, and is producing the food in compliance with 
sections 402 (21 U.S.C. 342) (regarding adulteration) and 403(w) (21 
U.S.C. 343(w)) (if applicable) (regarding misbranding with respect to 
labeling for the presence of major food allergens) of the FD&C Act. The 
regulations also provide for certain exemptions. To assist respondents 
with understanding the requirements we have developed Agency guidance, 
available at: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
    Specifically, regulations in 21 CFR 1.501 set forth the 
applicability of requirements for FSVP, while regulations in sections 
1.502 through 1.508, prescribe specific activities for developing, 
maintaining, and following an FSVP; as well as for evaluating 
compliance and for identifying and correcting hazards. Finally, 
regulations in section 1.509 identify required data elements applicable 
to food products offered for importation into the United States, while 
regulations in 1.510 govern required records, providing that records be 
made available to FDA upon request and that records be maintained 
electronically. On May 10, 2021, FDA launched the FSVP Importer Portal 
for FSVP Records Submission as a means for importers to upload FSVP 
records electronically and submit them to the Agency, after receiving a 
request for records from FDA. The portal may be found at https://www.access.fda.gov/, and a user guide is available at https://www.fda.gov/media/148312/download.
    We estimate the burden for the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR section                    Number of     responses per   Total annual          Average  burden per  response          Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemption for food for research; 1.501(c)...          36,360              40       1,454,400  0.083 (5 minutes).........................         120,715
Identifier for filing with U.S. Customs and           56,800             157       8,917,600  0.02 (1.2 minutes)........................         178,352
 Border Protection; 1.509.
                                             -----------------------------------------------------------------------------------------------------------

[[Page 4609]]

 
    Total...................................  ..............  ..............      10,372,000  ..........................................         299,067
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information collection.


                                                 Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
   Information collection activity; 21 CFR       Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                   section                     recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Controls for low-acid canned foods; 1.502(b)           2,443               4           9,772  1.........................................           9,772
Hazard determinations, controls, and audits;          56,800           87.74       4,984,036  0.38 (23 minutes).........................       1,917,174
 1.504, 1.506, 1.511.
Written assurances for food produced under            11,701            2.88          33,664  2.25......................................          75,744
 dietary supplement current good
 manufacturing practices; 1.511.
Document very small importer/certain small            50,450               1          50,450  1.........................................          50,450
 foreign supplier status; 1.512(b)(1).
Written assurances associated with very               50,450            2.79         141,084  2.25......................................         317,439
 small importer/certain small foreign
 supplier; 1.512(b)(3).
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............       5,219,006  ..........................................       2,370,579
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information collection.
\2\ Figures have been rounded to the nearest one hundredth.

    Upon evaluation of the information collection, we are retaining the 
currently approved burden estimates.

    Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01796 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P