Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 88635-88636 [2023-28290]
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Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests
for single copies of the guidance to the
Policy and Regulations Staff (HFV–6),
Center for Veterinary Medicine, Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Dorothy Bailey, Center for Veterinary
Medicine (HFV–50), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0565,
dorothy.bailey@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 15,
2020 (85 FR 42876), FDA published the
notice of availability for draft GFI #61
entitled ‘‘Special Considerations,
Incentives, and Programs to Support the
Approval of New Animal Drugs for
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Minor Uses and for Minor Species’’
giving interested persons until
November 12, 2020, to comment on the
draft guidance. In response to a request
for an extension, the comment period
was extended to January 11, 2021 (85 FR
71659). FDA received 14 comments on
the draft guidance and those comments
were considered as the guidance was
finalized. Changes to the final guidance
include the following:
• In our draft guidance we referred to
Minor Use Determinations. Our
experience has shown that our
stakeholders frequently confuse
‘‘MUMS Determination’’ with ‘‘MUMS
Designation.’’ Therefore, the final
guidance substitutes the word
‘‘Assessment’’ for the word
‘‘Determination.’’
• Section XII.C.3.a.i. ‘‘Anthelmintics
and Ectoparasiticides for Terrestrial
Minor Species’’ has been added to the
final guidance in response to comments
received requesting additional detail on
this subject. This section also references
the relevant ‘‘International Cooperation
on Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH)’’
guidance.
• CVM received many comments
pertaining to aquaculture species
grouping. Due to the complexity of this
topic, CVM has removed examples of
aquaculture species groupings in the
final guidance. We continue to consider
this topic and intend to work with
individual drug sponsors wishing to use
species groupings for new animal drug
approvals to identify an appropriate
species grouping strategy and
subsequent data needs for specific
projects.
In addition, editorial changes were
made to improve clarity. The guidance
announced in this notice finalizes the
draft guidance dated July 2020.
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Special
Considerations, Incentives, and
Programs to Support the Approval of
New Animal Drugs for Minor Uses and
for Minor Species.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
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88635
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 511 have
been approved under OMB control
number 0910–0117; the collections of
information in 21 CFR part 514 have
been approved under OMB control
numbers 0910–0032 and 0910–0284;
and the collections of information in 21
CFR part 516 have been approved under
OMB control numbers 0910–0605.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: December 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–28287 Filed 12–21–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2023–N–1157; FDA–
2022–D–0109; FDA–2020–N–0908; FDA–
2022–D–0814; FDA–2022–D–0745; FDA–
2023–N–1006; FDA–2023–N–1053; FDA–
2023–N–2286; FDA–2023–N–1661; FDA–
2013–N–1119; FDA–2023–N–2986; FDA–
2009–N–0582; FDA–2023–N–1272; FDA–
2023–N–2030; FDA–2023–N–1189]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
SUMMARY:
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Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1.—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Generic Clearance for Qualitative Data to Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed ..................................................................................................
Medical Devices—Voluntary Improvement Program ...............................................................................................
Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a
Master File in Support of Petitions, and Electronic Submission Using FDA Form 3503 ....................................
Infant Formula Requirements ..................................................................................................................................
Biologics License Applications; Procedures & Requirements .................................................................................
Medical Devices; Reports of Corrections and Removals ........................................................................................
Customer/Partner Satisfaction Service Surveys .....................................................................................................
Voluntary National Retail Food Regulatory Program Standards ............................................................................
Expanded Access to Investigational Drugs for Treatment Use ..............................................................................
Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified and Thermally Processed Low-Acid Foods .........................................................................................................................................
Color Additive Certification ......................................................................................................................................
Reporting and Recordkeeping Requirements for Reportable Food ........................................................................
Prescription Drug Advertisements; Presentation of Advertisements in Television and Radio ...............................
Submission to CDRH Allegations of Regulatory Misconduct Associated with Medical Devices ............................
Importation of Prescription Drugs ............................................................................................................................
Dated: December 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–28290 Filed 12–21–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]
Agency Father Generic Information
Collection Request; 60-Day Public
Comment Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment,
Improving Customer Experience (OMB
Circular A–11, Section 280
Implementation).
DATES: Comments on the ICR must be
received on or before February 20, 2024.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 264–0041 and PRA@HHS.GOV.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990-New-60D
and project title for reference, to
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:10 Dec 21, 2023
Jkt 262001
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, PRA@
HHS.GOV or call (202) 264–0041 the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Improving
Customer Experience (OMB Circular A–
11, Section 280.
Type of Collection: Father Generic
ICR.
OMB No.: 0990–XXXX, Office within
Office of the Secretary, Assistant
Secretary Administration.
Abstract: The Department of Health
and Human Services, Office of the
Secretary, Assistant Secretary
Administration is requesting approval
by OMB on a new Father Generic
Information Collection Request. OMB
Circular A–11 Section 280 established
government-wide standards for mature
customer experience organizations in
government and measurement. To
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Date approval
expires
0910–0891
0910–0922
9/30/2026
9/30/2026
0910–0016
0910–0256
0910–0338
0910–0359
0910–0360
0910–0621
0910–0814
10/31/2026
10/31/2026
10/31/2026
10/31/2026
10/31/2026
10/31/2026
10/31/2026
0910–0037
0910–0216
0910–0643
0910–0686
0910–0769
0910–0888
11/30/2026
11/30/2026
11/30/2026
11/30/2026
11/30/2026
11/30/2026
enable Federal programs to deliver the
experience taxpayers deserve, they must
undertake three general categories of
activities: conduct ongoing customer
research, gather and share customer
feedback, and test services and digital
products.
These data collection efforts may be
either qualitative or quantitative in
nature or may consist of mixed
methods. Additionally, data may be
collected via a variety of means,
including but not limited to electronic
or social media, direct or indirect
observation (i.e., in person, video and
audio collections), interviews,
questionnaires, surveys, and focus
groups. HHS will limit its inquiries to
data collections that solicit strictly
voluntary opinions or responses. Steps
will be taken to ensure anonymity of
respondents in each activity covered by
this request.
The results of the data collected will
be used to improve the delivery of
Federal services and programs. It will
include the creation of personas,
customer journey maps, and reports and
summaries of customer feedback data
and user insights. It will also provide
government-wide data on customer
experience that can be displayed on
performance.gov to help build
transparency and accountability of
Federal programs to the customers they
serve.
Implementation).
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]]>Agencies
[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88635-88636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28290]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2023-N-1157; FDA-2022-D-0109; FDA-2020-N-0908; FDA-
2022-D-0814; FDA-2022-D-0745; FDA-2023-N-1006; FDA-2023-N-1053; FDA-
2023-N-2286; FDA-2023-N-1661; FDA-2013-N-1119; FDA-2023-N-2986; FDA-
2009-N-0582; FDA-2023-N-1272; FDA-2023-N-2030; FDA-2023-N-1189]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507).
[[Page 88636]]
The OMB control number and expiration date of OMB approval for each
information collection are shown in table 1. Copies of the supporting
statements for the information collections are available on the
internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may
not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.
Table 1.--List of Information Collections Approved By OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Generic Clearance for Qualitative Data 0910-0891 9/30/2026
to Support Social and Behavioral
Research for Food, Dietary Supplements,
Cosmetics, and Animal Food and Feed....
Medical Devices--Voluntary Improvement 0910-0922 9/30/2026
Program................................
Submission of Petitions: Food Additive, 0910-0016 10/31/2026
Color Additive (Including Labeling),
Submission of Information to a Master
File in Support of Petitions, and
Electronic Submission Using FDA Form
3503...................................
Infant Formula Requirements............. 0910-0256 10/31/2026
Biologics License Applications; 0910-0338 10/31/2026
Procedures & Requirements..............
Medical Devices; Reports of Corrections 0910-0359 10/31/2026
and Removals...........................
Customer/Partner Satisfaction Service 0910-0360 10/31/2026
Surveys................................
Voluntary National Retail Food 0910-0621 10/31/2026
Regulatory Program Standards...........
Expanded Access to Investigational Drugs 0910-0814 10/31/2026
for Treatment Use......................
Food Canning Establishment Registration, 0910-0037 11/30/2026
Process Filing and Recordkeeping for
Acidified and Thermally Processed Low-
Acid Foods.............................
Color Additive Certification............ 0910-0216 11/30/2026
Reporting and Recordkeeping Requirements 0910-0643 11/30/2026
for Reportable Food....................
Prescription Drug Advertisements; 0910-0686 11/30/2026
Presentation of Advertisements in
Television and Radio...................
Submission to CDRH Allegations of 0910-0769 11/30/2026
Regulatory Misconduct Associated with
Medical Devices........................
Importation of Prescription Drugs....... 0910-0888 11/30/2026
------------------------------------------------------------------------
Dated: December 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28290 Filed 12-21-23; 8:45 am]
BILLING CODE 4164-01-P
