Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Safety; Federal-State Food Regulatory Program Standards, 54454-54455 [2021-21367]
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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
are able to request a user fee payment
refund or transfer online at https://
www.fda.gov/forindustry/userfees/
default.htm. This electronic submission
is intended to reduce the burden for
customers to submit a user fee payment
refund and transfer request.
In the Federal Register of April 29,
2021 (86 FR 22669), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
User Fee Payment Refund Request—Form FDA 3913
User Fee Payment Transfer Request—Form FDA
3914.
474
194
1
1
474
194
Total .......................................................................
........................
........................
........................
1 There
Dated: September 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21421 Filed 9–30–21; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2021–N–0341]
OMB Control Number 0910–0760—
Revision
Food and Drug Administration,
The Food and Drug
Administration (FDA or we) is
SUMMARY:
VerDate Sep<11>2014
18:04 Sep 30, 2021
Jkt 256001
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
Food Safety; Federal-State Food
Regulatory Program Standards
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Safety;
Federal-State Food Regulatory
Program Standards
Notice.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Food and Drug Administration
HHS.
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: Submit written comments
(including recommendations) on the
collection of information by November
1, 2021.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0760. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Total hours
0.40 (24 minutes)
0.25 (15 minutes)
190
49
...............................
239
are no capital costs or operating and maintenance costs associated with this collection of information.
The current burden estimate shows a
decrease of approximately 642 hours for
this information collection over that
reported previously. The change reflects
increased experience by the respondents
to correctly submit fee payments and
increased sophistication in use of the
forms to request payments made in
error. The use of the forms for the user
fee programs (e.g., Prescription Drug
User Fees, Generic Drug User Fees,
Animal Drug User Fees, Animal Generic
Drug User Fees, Biosimilar Drug User
Fees) are optional.
In addition, new information
technology applications have more
accurately calculated the number of
registrants of drug facilities/food
facilities/medical device facilities/
medicated feed facilities, and we have
therefore revised the number of
respondents to the information
collection.
AGENCY:
Average burden
per response
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
visit our website at: https://
www.fda.gov/federal-state-local-tribal-
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
and-territorial-officials/nationalintegrated-food-safety-system-ifssprograms-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 10
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, and Tribal regulatory
agencies.
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
E:\FR\FM\01OCN1.SGM
01OCN1
54455
Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
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 are available
to those respondents who currently
have an egg inspection contract with
FDA and thus are subject to auditing. A
copy of the ERPS has been posted to
FDA–2021–N–0341 and is available at
https://www.regulations.gov.
In the Federal Register of May 14,
2021 (86 FR 26528), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Type of respondents; activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
State, local, Territorial, and/or Tribal Governments; submission of data elements to FDA consistent with ERPS
10
10
100
50
5,000
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 50
burden hours per response is necessary
for the attendant recordkeeping and
submission of data elements to FDA. We
expect participation in the ERPS to
increase. Finally, upon submission of
the Information Collection Request, we
are correcting an inadvertent calculation
error in the total burden hours as
displayed on page 26530, in Table 1, in
our 60-day notice in the Federal
Register of May 14, 2021 (86 FR 26528).
Dated: September 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21367 Filed 9–30–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2021–N–0843]
Genus Medical Technologies LLC
Versus Food and Drug Administration;
Request for Information and
Comments; Extension of Comment
Period
Food and Drug Administration,
HHS.
Notice; request for information
and comments; extension of comment
period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
notice entitled ‘‘Genus Medical
Technologies LLC Versus Food and
Drug Administration; Request for
Information and Comments’’ that
appeared in the Federal Register of
SUMMARY:
VerDate Sep<11>2014
18:04 Sep 30, 2021
Jkt 256001
FDA is extending the comment
period for the notice published on
August 9, 2021 (86 FR 43553). Submit
either electronic or written comments
by November 30, 2021.
DATES:
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 November 30,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 30, 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.
ADDRESSES:
Electronic Submissions
Food and Drug Administration
AGENCY:
August 9, 2021. The Agency is taking
this action to allow interested persons
additional time to submit comments.
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.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
• 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–0843 for ‘‘Genus Medical
Technologies LLC Versus Food and
Drug Administration; Request for
Information and Comments.’’ 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
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54454-54455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21367]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0341]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 we) 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: Submit written comments (including recommendations) on the
collection of information by November 1, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0760. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[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.
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 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 10 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, and Tribal
regulatory agencies.
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
[[Page 54455]]
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 are available to those respondents who currently have an egg
inspection contract with FDA and thus are subject to auditing. A copy
of the ERPS has been posted to FDA-2021-N-0341 and is available at
https://www.regulations.gov.
In the Federal Register of May 14, 2021 (86 FR 26528), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
State, local, Territorial, and/or Tribal Governments; submission of 10 10 100 50 5,000
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 50 burden hours per response is necessary for the
attendant recordkeeping and submission of data elements to FDA. We
expect participation in the ERPS to increase. Finally, upon submission
of the Information Collection Request, we are correcting an inadvertent
calculation error in the total burden hours as displayed on page 26530,
in Table 1, in our 60-day notice in the Federal Register of May 14,
2021 (86 FR 26528).
Dated: September 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21367 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P
