Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption, 49469-49471 [2023-16151]
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Federal Register / Vol. 88, No. 145 / Monday, July 31, 2023 / Notices
Similar to the RFD process, we have
established the Pre-RFD process for
sponsors to obtain preliminary,
nonbinding feedback regarding medical
product classification and assignment.
Although Forms FDA 5003, 5004, and
5005 (pre-request and request for
designation forms) were previously
developed to facilitate information
collection for Pre-RFDs and RFDs, we
have more recently issued the following
Agency guidance documents to provide
instruction and recommendations to
respondents regarding the submission of
RFDs and Pre-RFDs.
• The guidance document entitled,
‘‘How to Write a Request for
Designation’’ (April 2011), provides
instruction regarding the information
that needs to be submitted to OCP in an
RFD as described in 21 CFR 3.7. The
guidance is available at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/howwrite-request-designation-rfd.
• The guidance document entitled
‘‘How to Prepare a Pre-Request for
Designation,’’ (February 2018) was
developed to assist sponsors in
obtaining a preliminary, non-binding
assessment regarding the classification
and assignment of products from OCP
through the Pre-RFD process. The
guidance explains the Pre-RFD process
and helps a sponsor understand the type
of information to provide in a Pre-RFD
submission. The guidance is available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/how-prepare-pre-requestdesignation-pre-rfd.
• This information collection also
includes burden associated with
Combination Product Agreement
Meetings (CPAM) requests. The
guidance document entitled,
‘‘Requesting FDA Feedback on
Combination Products,’’ (December
2020) was developed to discuss ways in
which combination product sponsors
can obtain feedback from FDA on
scientific and regulatory questions and
to describe best practices for FDA and
sponsors when interacting on these
topics. The guidance is available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/requesting-fda-feedbackcombination-products.
The guidance documents were issued
consistent with our good guidance
practice regulations in 21 CFR 10.115,
which provide for public comment at
any time.
The information collection also
includes regulations in 21 CFR part 4
that govern current good manufacturing
practice requirements and
postmarketing safety requirements for
combination products. We expect,
however, that burden attendant to the
associated recordkeeping, reporting,
and/or disclosure activities is already
accounted for in approved information
collections that apply to drug, device,
and/or biologic products specifically
and respectively. Therefore, we do not
ascribe separate burden in this
information collection request for the
activities generated by these
requirements.
Respondents to the information
collection are sponsors of medical
products, including combination
products. Based on submissions
received by OCP during fiscal years
2020, 2021, and 2022, we account for
135 respondents annually.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section; activity
Total annual
responses
Average
burden per
response
Total hours
3.7; request for designation (RFD) ......................................
Pre-RFD submissions ..........................................................
CPAM requests ....................................................................
55
77
3
1
1
1
55
77
3
24
24
25
1,320
1,848
75
Total ..............................................................................
........................
........................
........................
........................
3,243
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden reflects a
decrease in the number of respondents
(four respondents) and a corresponding
decrease in total hours (96 hours). Based
on a recent evaluation of CPAM requests
received from each product center in
fiscal years 2020, 2021, and 2022, our
estimated annual burden for CPAM
requests remains unchanged.
Dated: July 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2707]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; State Petitions for
Exemption From Preemption
AGENCY:
Food and Drug Administration,
HHS.
Notice.
[FR Doc. 2023–16150 Filed 7–28–23; 8:45 am]
ACTION:
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SUMMARY:
VerDate Sep<11>2014
18:11 Jul 28, 2023
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
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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 provisions of our reporting
requirements contained in FDA
regulations governing state petitions for
exemption from preemption.
Either electronic or written
comments on the collection of
information must be submitted by
September 29, 2023.
DATES:
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
September 29, 2023. Comments received
by mail/hand delivery/courier (for
ADDRESSES:
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Federal Register / Vol. 88, No. 145 / Monday, July 31, 2023 / Notices
written/paper submissions) will be
considered timely if they are received
on or before that date.
ddrumheller on DSK120RN23PROD with NOTICES1
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–
2023–N–2707 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; State
Petitions for Exemption from
Preemption.’’ 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
VerDate Sep<11>2014
18:11 Jul 28, 2023
Jkt 259001
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-201509-18/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:
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.
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,
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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.
State Petitions for Exemption From
Preemption—21 CFR 100.1
OMB Control Number 0910–0277—
Extension
This information collection supports
FDA regulations. Under section 403A(b)
of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 343–1(b)),
States may petition FDA for exemption
from Federal preemption of State food
labeling and standard-of-identity
requirements. Section 100.1(c) (21 CFR
100.1(c)) provides prerequisites a
petition must satisfy for an exemption
from preemption. Section 100.1(d) sets
forth the information a State is required
to submit in such a petition. The
petition may be submitted either as: (1)
an original and one copy or (2) an
original and a computer-readable disk
containing the petition. Contents of the
disk should be in a standard format. The
petition must be submitted to the
Dockets Management Staff at the
address provided in the section
‘‘Written/Paper Submissions.’’ The
information required under § 100.1
enables FDA to determine whether the
State food labeling or standard-ofidentity requirement satisfies the
criteria of section 403A(b) of the FD&C
Act for granting exemption from Federal
preemption.
Description of Respondents: The
respondents to this collection of
information are State and local
governments who regulate food labeling
and standards of identity.
We estimate the burden of this
collection of information as follows:
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Federal Register / Vol. 88, No. 145 / Monday, July 31, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
100.1; petition for exemption from preemption ....................
1
1
1
40
40
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for § 100.1 is
minimal because petitions for
exemption from preemption are seldom
submitted by States. In the next 3 years,
we estimate that one or fewer petitions
will be submitted annually.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: July 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–16151 Filed 7–28–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Amended Notice of Meeting
ddrumheller on DSK120RN23PROD with NOTICES1
Notice is hereby given of a change in
the meeting of the National Heart, Lung,
and Blood Institute Special Emphasis
Panel, Opportunities for Collaborative
Research at the NIH Clinical Center
(U01), August 24, 2023, 2:00 p.m. to
August 24, 2023, 4:00 p.m., National
Institutes of Health, Rockledge I, 6705
Rockledge Drive, Bethesda, MD, 20892
which was published in the Federal
Register on July 19, 2023, FR Doc 2023–
15228, 88 FRN 46172.
The National Heart, Lung, and Blood
Institute Special Emphasis Panel
meeting is being amended due to a
change of the meeting date and time
formats. The meeting will be held on
September 8, 2023, from 11:00 a.m. to
1:00 p.m. This meeting will be a videoassisted and closed to the public.
Dated: July 25, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–16133 Filed 7–28–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Arthritis and
Musculoskeletal and Skin Diseases
Advisory Council.
This will be a hybrid meeting held inperson and virtually and will be open to
the public as indicated below.
Individuals who plan to attend inperson or view the virtual meeting and
need special assistance or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The meeting
can be accessed from the NIH Videocast
at the following link: https://
videocast.nih.gov/.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Arthritis and
Musculoskeletal and Skin Diseases Advisory
Council
Date: August 29, 2023
Open: 9:00 a.m. to 1:00 p.m.
Agenda: Discussion of Program Policies
and Issues.
Place: National Institutes of Health,
Building 31, 6C Room A & B, 31 Center
Drive, Bethesda, MD 20892 (Hybrid Meeting)
Closed: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health,
Building 31, 6C Room A & B, 31 Center
Drive, Bethesda, MD 20892
Contact Person: Darren D. Sledjeski, Ph.D.
Director, Division of Extramural Activities
(DEA), National Institute of Arthritis and,
Musculoskeletal and Skin Diseases, 6701
Democracy BLVD., Bethesda, MD 20892,
(301) 451–7766, darren.sledjeski@nih.gov
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Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors attending a meeting on
campus or at an off-campus federal facility
will be asked to show one form of
identification (for example, a governmentissued photo ID, driver’s license, or passport)
and to state the purpose of their visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.niams.nih.gov/about/working-groups/
advisory-council, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: July 25, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–16135 Filed 7–28–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
E:\FR\FM\31JYN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 145 (Monday, July 31, 2023)]
[Notices]
[Pages 49469-49471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16151]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2707]
Agency Information Collection Activities; Proposed Collection;
Comment Request; State Petitions for Exemption From Preemption
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
provisions of our reporting requirements contained in FDA regulations
governing state petitions for exemption from preemption.
DATES: Either electronic or written comments on the collection of
information must be submitted by September 29, 2023.
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 September 29, 2023. Comments
received by mail/hand delivery/courier (for
[[Page 49470]]
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-2023-N-2707 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; State Petitions for Exemption
from Preemption.'' 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: 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: 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.
State Petitions for Exemption From Preemption--21 CFR 100.1
OMB Control Number 0910-0277--Extension
This information collection supports FDA regulations. Under section
403A(b) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21
U.S.C. 343-1(b)), States may petition FDA for exemption from Federal
preemption of State food labeling and standard-of-identity
requirements. Section 100.1(c) (21 CFR 100.1(c)) provides prerequisites
a petition must satisfy for an exemption from preemption. Section
100.1(d) sets forth the information a State is required to submit in
such a petition. The petition may be submitted either as: (1) an
original and one copy or (2) an original and a computer-readable disk
containing the petition. Contents of the disk should be in a standard
format. The petition must be submitted to the Dockets Management Staff
at the address provided in the section ``Written/Paper Submissions.''
The information required under Sec. 100.1 enables FDA to determine
whether the State food labeling or standard-of-identity requirement
satisfies the criteria of section 403A(b) of the FD&C Act for granting
exemption from Federal preemption.
Description of Respondents: The respondents to this collection of
information are State and local governments who regulate food labeling
and standards of identity.
We estimate the burden of this collection of information as
follows:
[[Page 49471]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
100.1; petition for exemption from preemption...................... 1 1 1 40 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for Sec. 100.1 is minimal because petitions
for exemption from preemption are seldom submitted by States. In the
next 3 years, we estimate that one or fewer petitions will be submitted
annually.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: July 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16151 Filed 7-28-23; 8:45 am]
BILLING CODE 4164-01-P
