Announcement of Solicitation of Written Comments on Proposed Healthy People 2030 Objectives, 64240-64241 [2022-22983]
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Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
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SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘In Vitro Release Test Studies for
Topical Products Submitted in
ANDAs.’’ This draft guidance provides
recommendations on IVRT studies for
locally acting liquid-based and/or other
semisolid topical products. This draft
guidance is intended to assist applicants
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Once validated, an IVRT study may
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This draft guidance is being issued
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practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
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ANDAs.’’ It does not establish any rights
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FDA or the public. You can use an
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and regulations.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of Solicitation of
Written Comments on Proposed
Healthy People 2030 Objectives
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary of
Health, Office of Disease Prevention and
Health Promotion.
ACTION: Notice.
AGENCY:
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information for the submission of
ANDAs have been approved under OMB
control number 0910–0001. Applicant
submission of controlled
correspondence related to generic drug
development and FDA approval is
approved under OMB control number
0910–0797. The collections of
information that support ‘‘Good
Laboratory Practice (GLP) for NonClinical Laboratory Studies’’ have been
approved under OMB control number
0910–0119. The collections of
information in 21 CFR part 320 for
‘‘Investigational New Drug Safety
Reporting Requirements for Human
Drug and Biological Products and Safety
Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans’’ have been
approved under OMB control number
0910–0014. The recordkeeping
requirement for CGMP sample retention
in 21 CFR 211.170 has been approved
under OMB control number 0910–0139.
The U.S. Department of
Health and Human Services (HHS)
solicits written comments on an
additional objective proposed to be
added to Healthy People 2030, and
written comments from the public
proposing additional new core,
developmental, or research objectives to
be included in Healthy People 2030.
Public comment informed the
development of Healthy People 2030.
HHS will provide opportunities for
public input periodically throughout the
decade to ensure Healthy People 2030
reflects current public health priorities
and public input. The updated set of
Healthy People 2030 objectives will be
incorporated on https://health.gov/
healthypeople. This updated set will
reflect further review and deliberation
by federal Healthy People topic area
workgroups, the Federal Interagency
Workgroup on Healthy People 2030, and
other federal subject matter experts.
DATES: Written comments will be
accepted through 11:59 p.m. ET,
December 2, 2022.
ADDRESSES: Written comments should
be submitted by email to
HP2030Comment@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Dana Rosenberg, Office of Disease
Prevention and Health Promotion, U.S.
Department of Health and Human
Services, 1101 Wootton Parkway, Suite
420, Rockville, MD 20852; Email:
HP2030@hhs.gov; Phone: 240–453–
6092.
III. Electronic Access
SUPPLEMENTARY INFORMATION:
II. Paperwork Reduction Act of 1995
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
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SUMMARY:
Since
1980, Healthy People has provided a
comprehensive set of national health
promotion and disease prevention
objectives with 10-year targets aimed at
improving the health of all. Healthy
People 2030 objectives present a picture
of the nation’s health at the beginning
of the decade, establish national goals
and targets to be achieved by the year
2030, and monitor progress over time.
The U.S. Department of Health and
Human Services (HHS) is soliciting the
submission of written comments
regarding one core objective proposed to
be added to Healthy People 2030. The
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Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
public is also invited to submit
proposals for additional new core,
developmental, or research objectives
that meet the criteria outlined below.
Healthy People 2030 is the product of
an extensive collaborative process that
relies on input from a diverse array of
individuals and organizations, both
within and outside the federal
government, with a common interest in
improving the nation’s health. Public
comments are a cornerstone of Healthy
People 2030. During the development of
Healthy People 2030, HHS asked for the
public’s comments to help shape the
initiative’s framework (vision, mission,
and overarching goals) and its
objectives. HHS plans to periodically
seek public comment to ensure Healthy
People 2030 remains relevant and
reflects emerging public health issues.
The public now is invited to comment
on one new core objective proposed to
be added to Healthy People 2030. This
new objective was developed by federal
subject matter experts, approved by the
Healthy People Federal Interagency
Workgroup and is presented for the
public’s review and comment. The
objective is:
1. Social Determinants of HealthNEW–07: Increase the proportion of the
voting age citizens who vote. Data
Source: Current Population Survey
(CPS), U.S. Census Bureau and the U.S.
Bureau of Labor Statistics (BLS).
The public is also invited to propose
additional core, developmental, or
research objectives for consideration
that address critical public health
issues. Proposed new objectives must
meet all the objective selection criteria
(see below).
Objective Selection Criteria
Core Objectives
lotter on DSK11XQN23PROD with NOTICES1
Core objectives must meet the
following 5 criteria to be included in
Healthy People 2030. Core objectives
should (1) have a reliable, nationally
representative data source with baseline
data no older than 2015; (2) have at least
2 additional data points beyond the
baseline during the decade; (3) be of
national importance; (4) have effective,
evidence-based interventions available
to achieve the objective; and (5) have
data to help address disparities and
achieve health equity.
Developmental Objectives
Developmental objectives will have
the following characteristics: (1)
represent high priority issues; (2) do not
have reliable baseline data yet; and (3)
have evidence-based interventions
available.
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Research Objectives
Research objectives will have the
following characteristics: (1) represent
key opportunities to make progress in
areas with limited prior research, a high
health or economic burden, or
significant disparities between
population groups; (2) may or may not
have reliable baseline data; and (3) do
not have evidence-based interventions
available.
Written comments and evidencebased information should be submitted
by email to HP2030Comment@hhs.gov
by 11:59 p.m. ET on December 2, 2022.
Comments received in response to this
notice will be reviewed and considered
by the Healthy People topic area
workgroups, Federal Interagency
Workgroup on Healthy People 2030, and
other federal subject matter experts.
Paul Reed,
RDML, U.S. Public Health Service, Deputy
Assistant Secretary for Health, Office of
Disease Prevention and Health Promotion.
[FR Doc. 2022–22983 Filed 10–21–22; 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 10(d) 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: Center for Scientific
Review Special Emphasis Panel; Small
Business: Digestive Sciences.
Date: November 18, 2022.
Time: 8:00 a.m. to 7:00 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: Ganesan Ramesh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2182,
MSC 7818, Bethesda, MD 20892, (301) 827–
5467, ganesan.ramesh@nih.gov.
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Name of Committee: Center for Scientific
Review Special Emphasis Panel; Substance
Use, Risks, Mechanisms, and Outcomes.
Date: November 18, 2022.
Time: 9:30 a.m. to 7:30 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: Izabella Zandberg, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, 6701 Rockledge Drive,
Bethesda, MD 20892, 301–594–0359,
izabella.zandberg@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neurodegenerative Disorders.
Date: November 18, 2022.
Time: 11:00 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: Roger Alan Bannister,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1010–D,
Bethesda, MD 20892, (301) 435–1042,
bannisterra@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Auditory System, Cognition and
Memory.
Date: November 21, 2022.
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: Pablo Miguel Blazquez
Gamez, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (301) 435–1042,
pablo.blazquezgamez@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA–RM–
22–015: IND-enabling Studies of Somatic
Genome Editing Therapeutic Leads.
Date: November 21–22, 2022.
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: Christopher Payne, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 402–3702, christopher.payne@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Cell and Molecular Biology.
Date: November 21–22, 2022.
Time: 9:30 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).
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]]>Agencies
[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64240-64241]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22983]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Announcement of Solicitation of Written Comments on Proposed
Healthy People 2030 Objectives
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of the Assistant Secretary of Health, Office of
Disease Prevention and Health Promotion.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The U.S. Department of Health and Human Services (HHS)
solicits written comments on an additional objective proposed to be
added to Healthy People 2030, and written comments from the public
proposing additional new core, developmental, or research objectives to
be included in Healthy People 2030. Public comment informed the
development of Healthy People 2030. HHS will provide opportunities for
public input periodically throughout the decade to ensure Healthy
People 2030 reflects current public health priorities and public input.
The updated set of Healthy People 2030 objectives will be incorporated
on https://health.gov/healthypeople. This updated set will reflect
further review and deliberation by federal Healthy People topic area
workgroups, the Federal Interagency Workgroup on Healthy People 2030,
and other federal subject matter experts.
DATES: Written comments will be accepted through 11:59 p.m. ET,
December 2, 2022.
ADDRESSES: Written comments should be submitted by email to
[email protected].
FOR FURTHER INFORMATION CONTACT: Dana Rosenberg, Office of Disease
Prevention and Health Promotion, U.S. Department of Health and Human
Services, 1101 Wootton Parkway, Suite 420, Rockville, MD 20852; Email:
[email protected]; Phone: 240-453-6092.
SUPPLEMENTARY INFORMATION: Since 1980, Healthy People has provided a
comprehensive set of national health promotion and disease prevention
objectives with 10-year targets aimed at improving the health of all.
Healthy People 2030 objectives present a picture of the nation's health
at the beginning of the decade, establish national goals and targets to
be achieved by the year 2030, and monitor progress over time. The U.S.
Department of Health and Human Services (HHS) is soliciting the
submission of written comments regarding one core objective proposed to
be added to Healthy People 2030. The
[[Page 64241]]
public is also invited to submit proposals for additional new core,
developmental, or research objectives that meet the criteria outlined
below.
Healthy People 2030 is the product of an extensive collaborative
process that relies on input from a diverse array of individuals and
organizations, both within and outside the federal government, with a
common interest in improving the nation's health. Public comments are a
cornerstone of Healthy People 2030. During the development of Healthy
People 2030, HHS asked for the public's comments to help shape the
initiative's framework (vision, mission, and overarching goals) and its
objectives. HHS plans to periodically seek public comment to ensure
Healthy People 2030 remains relevant and reflects emerging public
health issues.
The public now is invited to comment on one new core objective
proposed to be added to Healthy People 2030. This new objective was
developed by federal subject matter experts, approved by the Healthy
People Federal Interagency Workgroup and is presented for the public's
review and comment. The objective is:
1. Social Determinants of Health-NEW-07: Increase the proportion of
the voting age citizens who vote. Data Source: Current Population
Survey (CPS), U.S. Census Bureau and the U.S. Bureau of Labor
Statistics (BLS).
The public is also invited to propose additional core,
developmental, or research objectives for consideration that address
critical public health issues. Proposed new objectives must meet all
the objective selection criteria (see below).
Objective Selection Criteria
Core Objectives
Core objectives must meet the following 5 criteria to be included
in Healthy People 2030. Core objectives should (1) have a reliable,
nationally representative data source with baseline data no older than
2015; (2) have at least 2 additional data points beyond the baseline
during the decade; (3) be of national importance; (4) have effective,
evidence-based interventions available to achieve the objective; and
(5) have data to help address disparities and achieve health equity.
Developmental Objectives
Developmental objectives will have the following characteristics:
(1) represent high priority issues; (2) do not have reliable baseline
data yet; and (3) have evidence-based interventions available.
Research Objectives
Research objectives will have the following characteristics: (1)
represent key opportunities to make progress in areas with limited
prior research, a high health or economic burden, or significant
disparities between population groups; (2) may or may not have reliable
baseline data; and (3) do not have evidence-based interventions
available.
Written comments and evidence-based information should be submitted
by email to [email protected] by 11:59 p.m. ET on December 2, 2022.
Comments received in response to this notice will be reviewed and
considered by the Healthy People topic area workgroups, Federal
Interagency Workgroup on Healthy People 2030, and other federal subject
matter experts.
Paul Reed,
RDML, U.S. Public Health Service, Deputy Assistant Secretary for
Health, Office of Disease Prevention and Health Promotion.
[FR Doc. 2022-22983 Filed 10-21-22; 8:45 am]
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