60-Day FRN 2023

66010

Federal Register / Vol. 88, No. 185 / Tuesday, September 26, 2023 / Notices

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In response to recommendations
made by FDA in GFI #213,1 as part of
a strategy to address antimicrobial
resistance associated with the use of
antimicrobial drugs in animal
agriculture, sponsors of all NADAs and
ANADAs for antimicrobial drugs
important to human medicine
(medically important antimicrobial
drugs) approved for use in or on the
feed or in the drinking water of foodproducing animals worked with FDA
over a 3-year period from 2013 to 2016
to voluntarily withdraw approval of
indications that were not considered
necessary for ensuring animal health
(production indications). In response to
FDA recommendations made in GFI
#263,2 sponsors also voluntarily worked
with FDA to change the marketing
status of all remaining approved uses of
such new animal drugs from over-thecounter (OTC) to either by veterinary
prescription (Rx) or by veterinary feed
directive, as applicable.
In September 2016, FDA announced
that it intended to enter the next phase
of its efforts to mitigate antimicrobial
resistance by focusing on medically
important antimicrobials used in animal
feed or water that have at least one
therapeutic indication without a defined
duration of use. In a notice published in
the Federal Register of September 14,
2016 (81 FR 63187), the Agency
requested comments from the public
about how to establish appropriately
targeted durations of use for therapeutic
products within the scope of GFI #213
with no currently defined duration of
use. Public feedback received in
response to that request for information
was taken into consideration during
subsequent development of a concept
paper released in 2021.
On September 14, 2018, FDA released
a 5-year action plan for supporting
antimicrobial stewardship in veterinary
settings.3 This plan includes an action
item intended ‘‘to ensure that all
medically important antimicrobial drugs
used in the feed or drinking water of
1 See GFI #213, ‘‘New Animal Drugs and New
Animal Drug Combination Products Administered
in or on Medicated Feed or Drinking Water of FoodProducing Animals: Recommendations for Drug
Sponsors for Voluntarily Aligning Product Use
Conditions with GFI #209,’’ December 2013.
(https://www.fda.gov/media/83488/download)
2 See GFI #263, ‘‘Recommendations for Sponsors
of Medically Important Antimicrobial Drugs
Approved for Use in Animals to Voluntarily Bring
Under Veterinary Oversight All Products That
Continue to be Available Over-the-Counter,’’ June
2021. (https://www.fda.gov/media/130610/
download)
3 See FDA’s 5-year action plan entitled
‘‘Supporting Antimicrobial Stewardship in
Veterinary Settings: Goals for Fiscal Years 2019–
2023.’’ (https://www.fda.gov/media/115776/
download)

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food-producing animals have an
appropriately targeted duration of
use.’’ 4
In a notice published in the Federal
Register of January 11, 2021 (86 FR
1979), FDA requested comments from
the public on a concept paper that
outlined a potential framework for how
sponsors of NADAs and ANADAs for
products containing medically
important antimicrobial drugs approved
for use in or on the feed of foodproducing animals could voluntarily
work with FDA to change the approved
conditions of use of these drugs to
establish appropriately defined
durations of use for those indications
that currently have an undefined
duration of use. The concept paper
generated invaluable public comment;
FDA considered all information and
feedback received on the concept paper
as it developed this draft guidance.
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on ‘‘Defining Durations
of Use for Approved Medically
Important Antimicrobial Drugs Fed to
Food-Producing Animals.’’ 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
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 section 512(n)(1) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(n)(1)) have been
approved under OMB control number
0910–0669. The collections of
information in 21 CFR part 514 have
been approved under OMB control
number 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the draft 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.
4 See

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Action item 1.1.2 of the 5-year plan.

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Dated: September 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–20920 Filed 9–25–23; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0313–60D]

Agency 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.
DATES: Comments on the ICR must be
received on or before November 27,
2023.
ADDRESSES: Submit your comments to
[email protected] or by calling
(202) 264–0041 and [email protected].
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0313 and
project title for reference, to Sherrette A.
Funn, email: [email protected],
[email protected] 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: National Blood
Collection & Utilization Survey
(NBCUS).
Type of Collection: Revision.
OMB No.: 0990–0313 Office of the
Assistant Secretary for Health/HHS.
Abstract: The Office of the Assistant
Secretary for Health (OASH) is
requesting approval for a three-year
revised information collection request
(ICR) titled ‘‘National Blood Collection
& Utilization Survey (NBCUS).’’ The
NBCUS is a biennial survey that
SUMMARY:

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66011

Federal Register / Vol. 88, No. 185 / Tuesday, September 26, 2023 / Notices
includes a core of standard questions on
blood collection, processing, and
utilization practices. Questions on
transfusion-transmitted infections,
transfusion associated circulatory
overload, acute hemolysis, delayed
hemolysis, and severe allergic reactions
are also included in the survey. The
rapidly changing environment in blood
supply and demand makes it important

to have regular, periodic data describing
the state of U.S. blood collections and
transfusions for understanding the
dynamics of blood safety and
availability. In 2023, two sections were
removed from the survey related to the
impact of the COVID–19 pandemic on
the blood supply during the course of
2020.

Survey respondents will consist of
blood collection centers and hospitals
that perform blood transfusions, except
those reporting fewer than 100 inpatient
surgeries per year. For the purposes of
this ICR, federal burden is only being
placed on facilities located within the
fifty states and the District of Columbia.
The total estimated burden is 5,106
hours.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Total burden
hours

Transfusing Hospitals ......................................................................................
Hospital Blood Banks ......................................................................................
Community-based blood center .......................................................................

2754
83
53

1
1
1

1 hour, 46 min
1 hour, 46 min
1 hour, 46 min

4,865
147
94

Total ..........................................................................................................

2,890

........................

........................

5,106

Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2023–20865 Filed 9–25–23; 8:45 am]
BILLING CODE 4150–41–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; 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
would constitute a clearly unwarranted
invasion of personal privacy.

lotter on DSK11XQN23PROD with NOTICES1

Number
responses per
respondent

Number of
respondents

Type of respondent

Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Initial Review Group; Diabetes,
Endocrinology and Metabolic Diseases B
Study Section Diabetes, Endocrinology and
Metabolic Diseases B Study Section.
Date: October 25–27, 2023.
Time: 10:00 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, NIDDK
Democracy II, Suite 7000A, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).

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Contact Person: Charlene J. Repique, Ph.D.,
Scientific Review Officer, NIDDK/Scientific
Review Branch, National Institutes of Health,
6707 Democracy Blvd., Room 7013,
Bethesda, MD 20892, (301) 594–7791,
[email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: September 20, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–20753 Filed 9–25–23; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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

PO 00000

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would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Genomics Centers for
Infectious Diseases (U19 Clinical Trial Not
Allowed).
Date: October 24–25, 2023.
Time: 10:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F21B,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Maryam Feili-Hariri,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F21B,
Rockville, MD 20852, 240–669–5026,
[email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: September 20, 2023.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–20867 Filed 9–25–23; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as

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