[Federal Register Volume 89, Number 125 (Friday, June 28, 2024)]
[Notices]
[Pages 54009-54010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14329]



[[Page 54009]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2275]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Produce Regulatory Program Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on collections of information associated with 
our Produce Regulatory Program Standards (PRPS).

DATES: Either electronic or written comments on the collection of 
information must be submitted by August 27, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 27, 2024. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received 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-2024-N-2275 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Produce Regulatory Program 
Standards.'' 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 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 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.

[[Page 54010]]

Produce Regulatory Program Standards

OMB Control Number--0910-NEW

    This information collection helps establish and implement FDA's 
``Produce Regulatory Program Standards.'' Section 1012 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 399c) authorizes FDA to 
administer training and education programs for employees of State, 
local, Territorial, and Tribal food safety authorities relating to 
regulatory programs. Also, under section 205 of the FDA Safety 
Modernization Act (codified in 21 U.S.C. 2224), FDA, together with the 
Centers for Disease Control and Prevention is directed to enhance 
foodborne illness surveillance to improve the collection, analysis, 
reporting, and usefulness of data on foodborne illnesses. As part of 
this effort, we have initiated programs that include developing and 
instituting regulatory standards intended to reduce the risk of 
foodborne illness through coordinated efforts with our strategic 
partners. Regulatory program standards establish a uniform foundation 
for the design and management of State, local, Tribal, and Territorial 
programs that have the responsibility for regulating human and animal 
food. Partnering with other regulatory officials also helps maximize 
limited resources in administering FDA regulations pertaining to the 
manufacturing/processing, packing, or holding of food for consumption 
in the United States.
    The PRPS are the result of external collaboration and coordination 
with the Association of Food and Drug Officials (AFDO), the National 
Association of State Departments of Agriculture (NASDA), and state 
produce regulatory programs. FDA, NASDA, AFDO, and states worked 
collaboratively to develop the content of the PRPS. A copy of the 
standards and accompanying worksheets and forms is available in the 
Federal Register docket for this notice. We recommend that State and 
Territorial produce safety regulatory programs use these program 
standards as the framework to design and manage their produce safety 
regulatory programs. The states that assisted in the development of 
PRPS were representative of the 43 State and Territorial programs 
regulatory programs enrolled currently conducting produce safety 
inspections via funding from a cooperative agreement grant, ``The FDA's 
Cooperative Agreement Program for States and Territories to Implement a 
National Produce Safety Program, PAR-21-174,'' (this program also 
includes 4 programs which do not conduct inspections). For more 
information on this cooperative agreement, we invite you to visit our 
website at: https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/grants-and-cooperative-agreements/fda-state-produce-safety-implementation-cooperative-agreement-program.
    The PRPS identifies and includes resource and training material for 
the following standards: regulatory foundations; training; inspection; 
product-specific illnesses, outbreaks and hazard response; compliance 
and enforcement; industry and community relations; program assessments; 
and product sampling and testing. We recommend using the worksheets and 
forms contained in the standards, however, alternate forms that are 
equivalent may be used. The educational worksheets and resource 
materials include recordkeeping and reporting activities that help FDA 
verify participation and successful completion of the respective 
requirements. In the first year of enrollment, information is used to 
conduct a baseline self-assessment to determine whether the materials 
meet the elements of each standard. In subsequent years, we use the 
information to conduct a comprehensive review and evaluate program 
effectiveness and participation. We modify the program standards based 
on the ongoing assessments as well as comments and informal feedback 
obtained from participants.
    Description of Respondents: Respondents are State Departments of 
Agriculture or Health regulatory officials who enroll in the PRPS 
(State or Territorial governments). Currently we estimate 43 
respondents to the information collection based on expected 
participation.
    We estimate the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of
                  Information collection activity                       Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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State or Territorial Governments; Development and reporting of data              43               11              473               88           41,624
 consistent with PRPS..............................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    To demonstrate conformance with the standards prior to and after 
enrollment in the grant program, State and Territorial governments 
participating in the PRPS (respondents) will submit comprehensive 
program assessments and evaluations to their technical advisors at FDA 
using a dedicated email. The information required for these submissions 
is outlined in the provided worksheets. Additionally, the PRPS requires 
ongoing documentation to verify conformance. We estimate, based on the 
implementation of other standards programs and informal consultation 
with the affected State and Territorial governments, that the 
information collection activities will average 968 hours annually for 
each of the 43 participants, for a total of 41,624 hours.

    Dated: June 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-14329 Filed 6-27-24; 8:45 am]
BILLING CODE 4164-01-P