Agency Information Collection Activities; Proposed Collection; Comment Request; Food Safety; Federal-State Food Regulatory Program Standards
| Published date | 14 May 2021 |
| Citation | 86 FR 26528 |
| Record Number | 2021-10180 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 86 Issue 92 (Friday, May 14, 2021)
[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26528-26530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10180]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0341]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Safety; Federal-State Food Regulatory Program
Standards
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of
[[Page 26529]]
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 revision 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
associated with FDA's Federal-State Food Regulatory Program Standards.
DATES: Submit either electronic or written comments on the collection
of information by July 13, 2021.
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 July 13, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 13, 2021. 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-2021-N-0341 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Safety; Federal-State Food
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, including
each proposed revision 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.
Food Safety; Federal-State Food Regulatory Program Standards
OMB Control Number 0910-0760--Revision
This information collection supports implementation of FDA's
Federal-State Regulatory Program Standards, part of our National
Integrated Food Safety System (IFSS) Programs and Initiatives. For more
information we invite you to
[[Page 26530]]
visit our website at: https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/national-integrated-food-safety-system-ifss-programs-and-initiatives. In the United States, Federal and State
governments work cooperatively to ensure the safety of food intended
for both human and animal consumption. Part of this effort includes
developing and maintaining uniform review criteria by which to assess
food safety. FDA has established and maintains a number of program
standards aimed at improving the safety evaluation for certain food
products including manufactured foods and animal feed. Similarly, we
are establishing regulatory program standards for eggs and have
developed the ``Eggs Regulatory Program Standards'' (ERPS). The ERPS is
intended for use by State and local regulatory officials and identifies
ten elements we believe are essential to the effective regulatory
assessment of egg safety. States are encouraged to build systems that
are sustainable and implement plans corresponding to the IFSS.
In the course of their normal duties, State, local, Territorial,
and Tribal governments collect information pertaining to compliance
with the respective State, local, Territorial, and tribal food safety
requirements within their jurisdictions. Although content and format of
the information collected may vary, these activities are a usual and
customary part of routine regulatory oversight. Respondents to the
information collection are State, local, Territorial, Tribal, and
Federal regulatory agencies participating in FDA's Voluntary National
Retail Food Regulatory Program Standards (information collection
currently approved under OMB control number 0910-0621). Consistent with
the ERPS, respondents will submit the following information to FDA: (1)
Program self-assessment; (2) risk factor study of the regulated
industry; and (3) independent outside audit (verification audit).
The ERPS offers forms, worksheets, and templates to help
respondents assess and meet the program elements identified and
discussed. Respondents are not required to use the sample collection
instruments included in the ERPS, however all data elements should be
submitted to FDA and supporting documentation retained. The ERPS is not
intended to address any performance appraisal processes that any State,
local, Territorial, or tribal agency may use to evaluate its employees'
performance. Funding opportunities are available to respondents who
choose to implement the ERPS, however these opportunities are limited
and contingent upon the availability of funds, and to those respondents
who currently have an egg inspection contract with FDA and thus subject
to auditing. A copy of the ERPS has been posted to FDA-2021-N-0341 and
is available at https://www.regulations.gov.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Respondents; information collection activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
State, Local, Territorial, and/or Tribal Governments; submission of 10 10 100 500 500,000
data elements to FDA consistent with ERPS.........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our experience with similar information collection, we
estimate an initial 10 respondents will participate in the ERPS, and
assume an average of 500 hours is necessary for the attendant
recordkeeping and submission of data elements to FDA. We expect
participation in the ERPS to increase.
Dated: May 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10180 Filed 5-13-21; 8:45 am]
BILLING CODE 4164-01-P
