Regional Pediatric Pandemic Network, 67766-67767 [2023-21670]
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Federal Register / Vol. 88, No. 189 / Monday, October 2, 2023 / Notices
available, you can provide this
information on the cover sheet and not
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‘‘confidential.’’ Any information marked
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Submit written requests for single
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Send one self-addressed adhesive label
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INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Chris Wheeler, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3330,
Silver Spring, MD 20993–0002, 301–
796–0151; or Anne Taylor, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
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7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Human Prescription Drug and
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Biological Products—Labeling for
Dosing Based on Weight or Body
Surface Area for Ready-to-Use
Containers—‘Dose Banding.’ ’’ This
guidance provides recommendations for
incorporating dose banding information
into the labeling of an injectable drug
product that is seeking approval through
a new drug application submitted under
section 505(b) of the FD&C Act (21
U.S.C. 355(b)), a biologics license
application submitted under section
351(a) of the PHS Act (42 U.S.C. 262(a)),
or a supplement to one of these
approved applications. The
recommendations and examples in this
guidance are relevant to situations in
which an applicant (1) proposes to
develop ready-to-use containers with a
range of different strengths for an
injectable drug product and (2) seeks to
incorporate dose banding information
into the prescribing information based
on dosing information of a previously
approved drug product that is based on
weight or BSA.
This guidance finalizes the draft
guidance entitled ‘‘Human Prescription
Drug and Biological Products—Labeling
for Dosing Based on Weight or Body
Surface Area for Ready-to-Use
Containers—‘Dose Banding’ ’’ issued on
July 21, 2022 (87 FR 43533). FDA
considered comments received on the
draft guidance as it developed the final
guidance. Changes from the draft
guidance are primarily intended to
improve clarity.
This 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 ‘‘Human
Prescription Drug and Biological
Products—Labeling for Dosing Based on
Weight or Body Surface Area for Readyto-Use Containers—‘Dose Banding.’ ’’ 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 new
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by Office of Management Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521). The collections of information in
21 CFR part 201 have been approved
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under OMB control number 0910–0572;
the collections of information in 21 CFR
part 314 have been approved under
OMB control number 0910–0001; and
the collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: September 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–21558 Filed 9–29–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Regional Pediatric Pandemic Network
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Announcing supplemental
funding for Regional Pediatric Pandemic
Network award recipients in Maryland
and Ohio.
AGENCY:
HRSA provided additional
award funds to the two Regional
Pediatric Pandemic Network (RPPN)
Program recipients in Maryland and
Ohio with periods of performance
ending in fiscal year 2024.
FOR FURTHER INFORMATION CONTACT: Sara
Kinsman, MD, Director, Division of
Child, Adolescent and Family Health,
Maternal and Child Bureau, Health
Resources and Services Administration,
at SKinsman@hrsa.gov and 301–443–
2250.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Intended Recipient(s) of the Award:
The two award recipients of the HRSA
Regional Pediatric Pandemic Network
Program are Children’s National
Medical Center in Maryland, and
University Hospitals Cleveland Medical
Center in Ohio, as listed in Table 1.
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Federal Register / Vol. 88, No. 189 / Monday, October 2, 2023 / Notices
TABLE 1—RECIPIENTS AND SUPPLEMENT AWARD AMOUNTS
Grant No.
Award recipient name
U1IMC45814 ..................................................
U1IMC43532 ..................................................
Children’s National Medical Center ....................................................
University Hospitals Cleveland Medical Center .................................
Amount of Non-Competitive
Award(s): Two awards at $400,000 per
grant recipient totaling $800,000.
Project Period: September 1, 2023, to
August 31, 2024.
Assistance Listing (CFDA) Number:
93.110.
Award Instrument: Supplement for
RPPN support services.
Justification: Approximately $400,000
in supplemental funding has been
awarded to each RPPN cooperative
agreement recipient to increase
activities to coordinate among the
nation’s pediatric hospitals and their
communities to prepare for and respond
to global health threats and coordinate
research-informed responses to future
pandemics. Projects approved by HRSA
under this supplement are to be
performed from the date of award
through August 31, 2024.
Carole Johnson,
Administrator.
[FR Doc. 2023–21670 Filed 9–29–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Charter Renewal for the Advisory
Committee on Infant and Maternal
Mortality
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
Department of Health and Human
Services is giving notice that the
Advisory Committee on Infant and
Maternal Mortality (ACIMM or
Committee) is renewed. The effective
date of the charter renewal is September
30, 2023.
FOR FURTHER INFORMATION CONTACT:
Vanessa Lee, MPH, Designated Federal
Official, Maternal and Child Health
Bureau, HRSA, 5600 Fishers Lane,
Room 18N84, Rockville, Maryland
20857; 301–443–0543; or VLee1@
hrsa.gov.
SUPPLEMENTARY INFORMATION: ACIMM is
authorized by section 222 of the Public
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SUMMARY:
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Health Service Act (42 U.S.C. 217a), as
amended. The Committee is governed
by provisions of Public Law 92–463, as
amended (5 U.S.C. 10), which sets forth
standards for the formation and use of
Advisory Committees. ACIMM advises
the Secretary of Health and Human
Services on department activities,
partnerships, policies, and programs
directed at reducing infant mortality,
maternal mortality and severe maternal
morbidity, and improving the health
status of infants and women before,
during, and after pregnancy. The
Committee provides advice on how best
to coordinate Federal, State, local,
Tribal, and Territorial governmental
efforts designed to improve infant
mortality, related adverse birth
outcomes, and maternal health, as well
as influence similar efforts in the private
and voluntary sectors. The Committee
provides guidance and
recommendations on the policies,
programs, and resources required to
address the disparities and inequities in
infant mortality, related adverse birth
outcomes and maternal health
outcomes, including maternal mortality
and severe maternal morbidity. With its
focus on underlying causes of the
disparities and inequities seen in birth
outcomes for women and infants, the
Committee advises the Secretary of
Health and Human Services on the
health, social, economic, and
environmental factors contributing to
the inequities and proposes structural,
policy and/or systems level changes.
The charter renewal for ACIMM was
approved on September 8, 2023. The
filing date is September 30, 2023.
Renewal of the ACIMM charter gives
authorization for the committee to
operate until September 30, 2025.
A copy of the ACIMM charter is
available on the ACIMM website at
https://www.hrsa.gov/advisorycommittees/infant-mortality/.
A copy of the charter also can be
obtained by accessing the FACA
database that is maintained by the
Committee Management Secretariat
under the General Services
Administration. The website address for
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City, state
Award amount
MD
OH
$400,000
400,000
the FACA database is https://
www.facadatabase.gov/.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–21716 Filed 9–29–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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: Cardiovascular and
Respiratory Sciences Integrated Review
Group, Therapeutic Development and
Preclinical Studies Study Section.
Date: October 25–26, 2023.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Richard D Schneiderman,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138,
Bethesda, MD 20817, 301–402–3995,
richard.schneiderman@nih.gov.
Name of Committee: Interdisciplinary
Molecular Sciences and Training Integrated
Review Group, Cellular and Molecular
Technologies Study Section.
Date: October 25–26, 2023.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Tatiana V Cohen, Ph.D.,
Scientific Review Officer, Center for
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[Federal Register Volume 88, Number 189 (Monday, October 2, 2023)]
[Notices]
[Pages 67766-67767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21670]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Regional Pediatric Pandemic Network
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Announcing supplemental funding for Regional Pediatric Pandemic
Network award recipients in Maryland and Ohio.
-----------------------------------------------------------------------
SUMMARY: HRSA provided additional award funds to the two Regional
Pediatric Pandemic Network (RPPN) Program recipients in Maryland and
Ohio with periods of performance ending in fiscal year 2024.
FOR FURTHER INFORMATION CONTACT: Sara Kinsman, MD, Director, Division
of Child, Adolescent and Family Health, Maternal and Child Bureau,
Health Resources and Services Administration, at [email protected] and
301-443-2250.
SUPPLEMENTARY INFORMATION:
Intended Recipient(s) of the Award: The two award recipients of the
HRSA Regional Pediatric Pandemic Network Program are Children's
National Medical Center in Maryland, and University Hospitals Cleveland
Medical Center in Ohio, as listed in Table 1.
[[Page 67767]]
Table 1--Recipients and Supplement Award Amounts
----------------------------------------------------------------------------------------------------------------
Grant No. Award recipient name City, state Award amount
----------------------------------------------------------------------------------------------------------------
U1IMC45814............................... Children's National Medical MD $400,000
Center.
U1IMC43532............................... University Hospitals OH 400,000
Cleveland Medical Center.
----------------------------------------------------------------------------------------------------------------
Amount of Non-Competitive Award(s): Two awards at $400,000 per
grant recipient totaling $800,000.
Project Period: September 1, 2023, to August 31, 2024.
Assistance Listing (CFDA) Number: 93.110.
Award Instrument: Supplement for RPPN support services.
Justification: Approximately $400,000 in supplemental funding has
been awarded to each RPPN cooperative agreement recipient to increase
activities to coordinate among the nation's pediatric hospitals and
their communities to prepare for and respond to global health threats
and coordinate research-informed responses to future pandemics.
Projects approved by HRSA under this supplement are to be performed
from the date of award through August 31, 2024.
Carole Johnson,
Administrator.
[FR Doc. 2023-21670 Filed 9-29-23; 8:45 am]
BILLING CODE 4165-15-P
