Notice2024-14329
Agency Information Collection Activities; Proposed Collection; Comment Request; Produce Regulatory Program Standards
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 28, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 89 Issue 125 (Friday, June 28, 2024)</title>
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[Federal Register Volume 89, Number 125 (Friday, June 28, 2024)]
[Notices]
[Pages 54009-54010]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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:
<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-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 <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 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#36666477654257505076505257185e5e4518515940"><span class="__cf_email__" data-cfemail="510103100225303737113735307f3939227f363e27">[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 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: <a href="https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/grants-and-cooperative-agreements/fda-state-produce-safety-implementation-cooperative-agreement-program">https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/grants-and-cooperative-agreements/fda-state-produce-safety-implementation-cooperative-agreement-program</a>.
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
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