Charter Renewal for the Advisory Committee on Infant and Maternal Mortality (Formerly the Advisory Committee on Infant Mortality), 54221 [2021-21277]
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Federal Register / Vol. 86, No. 187 / Thursday, September 30, 2021 / Notices
use of RWE to: (1) Help to support the
approval of a new indication for a drug
approved under section 505(c) of the
FD&C Act (21 U.S.C. 355(c)); and (2)
help to support or satisfy postapproval
study requirements. This section also
requires that FDA use the program to
inform guidance for industry on the
circumstances under which sponsors of
drugs may rely on RWE and the
appropriate standards and
methodologies for the collection and
analysis of RWE submitted to evaluate
the potential use of RWE for those
purposes. Further, under the
Prescription Drug User Fee
Amendments of 2017 (PDUFA VI), FDA
committed to the goal of publishing
draft guidance on how RWE can
contribute to the assessment of safety
and effectiveness in regulatory
submissions.
FDA is issuing the draft guidance as
part of a series of guidance documents
to satisfy the Cures Act mandate and the
PDUFA VI goal. The RWE Program will
cover clinical studies that use realworld data sources, such as information
from routine clinical practice, to derive
RWE.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Real-World Data: Assessing
Electronic Health Records and Medical
Claims Data to Support Regulatory
Decision-Making for Drug and
Biological Products.’’ 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.
LOTTER on DSK11XQN23PROD with NOTICES1
II. Paperwork Reduction Act of 1995
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 in 21 CFR part 11 have been
approved under OMB control number
0910–0303; the collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; 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
VerDate Sep<11>2014
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been approved under OMB control
number 0910–0338.
III. Electronic Access
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/
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 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21315 Filed 9–29–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Charter Renewal for the Advisory
Committee on Infant and Maternal
Mortality (Formerly the Advisory
Committee on Infant Mortality)
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, HHS
is hereby giving notice that the Advisory
Committee on Infant Mortality has been
renamed the Advisory Committee on
Infant and Maternal Mortality (ACIMM)
and has been renewed.
DATES: The effective date of the charter
renewal is September 30, 2021.
FOR FURTHER INFORMATION CONTACT:
Vanessa Lee, MPH, Designated Federal
Official, HRSA, Maternal and Child
Health Bureau, 5600 Fishers Lane,
18N84, Rockville, Maryland 20857;
(301) 443–0543; or VLee1@hrsa.gov.
SUPPLEMENTARY INFORMATION: ACIMM is
authorized by section 222 of the Public
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. App. 2), which sets
forth standards for the formation and
use of Advisory Committees. ACIMM
advises the Secretary of HHS 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,
SUMMARY:
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54221
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. ACIMM 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 on the health, social,
economic, and environmental factors
contributing to the inequities and
proposes structural, policy, and/or
systems level changes.
The charter renewal and name change
for ACIMM was approved on September
30, 2021, which will also stand as the
filing date. Renewal of the ACIMM
charter gives authorization for the
ACIMM committee to operate until
September 30, 2023.
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
the FACA database is https://
www.facadatabase.gov/.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–21277 Filed 9–29–21; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: The HRSA
Community-Based Outreach Reporting
Module, OMB #0906–0064, Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
E:\FR\FM\30SEN1.SGM
Notice.
30SEN1
]]>Agencies
[Federal Register Volume 86, Number 187 (Thursday, September 30, 2021)]
[Notices]
[Page 54221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21277]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Charter Renewal for the Advisory Committee on Infant and Maternal
Mortality (Formerly the Advisory Committee on Infant Mortality)
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, HHS is
hereby giving notice that the Advisory Committee on Infant Mortality
has been renamed the Advisory Committee on Infant and Maternal
Mortality (ACIMM) and has been renewed.
DATES: The effective date of the charter renewal is September 30, 2021.
FOR FURTHER INFORMATION CONTACT: Vanessa Lee, MPH, Designated Federal
Official, HRSA, Maternal and Child Health Bureau, 5600 Fishers Lane,
18N84, Rockville, Maryland 20857; (301) 443-0543; or [email protected].
SUPPLEMENTARY INFORMATION: ACIMM is authorized by section 222 of the
Public 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.
App. 2), which sets forth standards for the formation and use of
Advisory Committees. ACIMM advises the Secretary of HHS 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. ACIMM 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 on the health,
social, economic, and environmental factors contributing to the
inequities and proposes structural, policy, and/or systems level
changes.
The charter renewal and name change for ACIMM was approved on
September 30, 2021, which will also stand as the filing date. Renewal
of the ACIMM charter gives authorization for the ACIMM committee to
operate until September 30, 2023.
A copy of the ACIMM charter is available on the ACIMM website at
https://www.hrsa.gov/advisory-committees/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 the FACA
database is https://www.facadatabase.gov/.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021-21277 Filed 9-29-21; 8:45 am]
BILLING CODE 4165-15-P
