Meeting of the Advisory Committee on Infant Mortality, 52355 [2020-18565]
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Federal Register / Vol. 85, No. 165 / Tuesday, August 25, 2020 / Notices
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that EVRYSDI
(risdiplam), manufactured by Genentech
Inc., meets the criteria for a priority
review voucher.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that EVRYSDI
(risdiplam), manufactured by Genentech
Inc., meets the criteria for a priority
review voucher. EVRYSDI (risdiplam) is
indicated for the treatment of spinal
muscular atrophy in pediatric and adult
patients.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about EVRYSDI
(risdiplam), go to the ‘‘Drugs@FDA’’
website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
khammond on DSKJM1Z7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: August 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–18648 Filed 8–24–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of 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, this
notice announces that the Secretary’s
Advisory Committee on Infant Mortality
(ACIM or Committee) has scheduled a
public meeting. Information about
ACIM and the agenda for this meeting
can be found on the ACIM website at
https://www.hrsa.gov/advisorycommittees/infant-mortality/.
DATES: September 23, 2020, 11 a.m.–6
p.m. Eastern Time (ET) and September
24, 2020, 11 a.m.–3:30 p.m. ET.
ADDRESSES: This meeting will be held
via webinar.
• The webinar link will be available
at ACIM’s website before the meeting:
https://www.hrsa.gov/advisorycommittees/infant-mortality/.
• The conference call-in number will
be available at ACIM’s website before
the meeting: https://www.hrsa.gov/
advisory-committees/infant-mortality/
index.html.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
David S. de la Cruz, Ph.D., MPH,
Designated Federal Official, Maternal
and Child Health Bureau (MCHB),
HRSA, 5600 Fishers Lane, Room 18N25,
Rockville, Maryland 20857; 301–443–
0543; or SACIM@hrsa.gov.
SUPPLEMENTARY INFORMATION: The ACIM
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.
The ACIM advises the Secretary of
HHS on department activities and
programs directed at reducing infant
mortality and improving the health
status of pregnant women and infants.
The ACIM represents a public-private
partnership at the highest level to
provide guidance and focus attention on
the policies and resources required to
address the reduction of infant mortality
and the improvement of the health
status of pregnant women and infants.
With a focus on life course, the ACIM
addresses disparities in maternal health
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
52355
to improve maternal health outcomes,
including preventing and reducing
maternal mortality and severe maternal
morbidity. The ACIM provides advice
on how best to coordinate a myriad of
federal, state, local, and private
programs and efforts that are designed
to deal with the health and social
problems impacting infant mortality and
maternal health, including
implementation of the Healthy Start
program and maternal and infant health
objectives from the National Health
Promotion and Disease Prevention
Objectives.
The agenda for the September 23–24,
2020, meeting is being finalized and
may include the following: Updates
from HRSA, MCHB, and other federal
agencies, continued discussion of the
impact of COVID–19 on infant and
maternal health, and updates on priority
topic areas for ACIM to address (equity,
data, access, and quality of care).
Agenda items are subject to change as
priorities dictate. Refer to the ACIM
website above for any updated
information concerning the meeting.
Members of the public will have the
opportunity to provide written or oral
comments. Requests to submit a written
statement or make oral comments to the
ACIM should be sent to David S. de la
Cruz, using the email address above at
least 3 business days prior to the
meeting. Public participants may submit
written statements in advance of the
scheduled meeting by emailing SACIM@
hrsa.gov. Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Individuals who plan to attend and
need special assistance or another
reasonable accommodation should
notify David S. de la Cruz at the contact
information listed above at least 10
business days prior to the meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–18565 Filed 8–24–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Cancer Institute
Clinical Trials and Translational
Research Advisory Committee.
The meeting will be held as a virtual
meeting and is open to the public.
E:\FR\FM\25AUN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 165 (Tuesday, August 25, 2020)]
[Notices]
[Page 52355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18565]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of 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, this
notice announces that the Secretary's Advisory Committee on Infant
Mortality (ACIM or Committee) has scheduled a public meeting.
Information about ACIM and the agenda for this meeting can be found on
the ACIM website at https://www.hrsa.gov/advisory-committees/infant-mortality/.
DATES: September 23, 2020, 11 a.m.-6 p.m. Eastern Time (ET) and
September 24, 2020, 11 a.m.-3:30 p.m. ET.
ADDRESSES: This meeting will be held via webinar.
The webinar link will be available at ACIM's website
before the meeting: https://www.hrsa.gov/advisory-committees/infant-mortality/.
The conference call-in number will be available at ACIM's
website before the meeting: https://www.hrsa.gov/advisory-committees/infant-mortality/.
FOR FURTHER INFORMATION CONTACT: David S. de la Cruz, Ph.D., MPH,
Designated Federal Official, Maternal and Child Health Bureau (MCHB),
HRSA, 5600 Fishers Lane, Room 18N25, Rockville, Maryland 20857; 301-
443-0543; or [email protected].
SUPPLEMENTARY INFORMATION: The ACIM 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.
The ACIM advises the Secretary of HHS on department activities and
programs directed at reducing infant mortality and improving the health
status of pregnant women and infants. The ACIM represents a public-
private partnership at the highest level to provide guidance and focus
attention on the policies and resources required to address the
reduction of infant mortality and the improvement of the health status
of pregnant women and infants. With a focus on life course, the ACIM
addresses disparities in maternal health to improve maternal health
outcomes, including preventing and reducing maternal mortality and
severe maternal morbidity. The ACIM provides advice on how best to
coordinate a myriad of federal, state, local, and private programs and
efforts that are designed to deal with the health and social problems
impacting infant mortality and maternal health, including
implementation of the Healthy Start program and maternal and infant
health objectives from the National Health Promotion and Disease
Prevention Objectives.
The agenda for the September 23-24, 2020, meeting is being
finalized and may include the following: Updates from HRSA, MCHB, and
other federal agencies, continued discussion of the impact of COVID-19
on infant and maternal health, and updates on priority topic areas for
ACIM to address (equity, data, access, and quality of care). Agenda
items are subject to change as priorities dictate. Refer to the ACIM
website above for any updated information concerning the meeting.
Members of the public will have the opportunity to provide written
or oral comments. Requests to submit a written statement or make oral
comments to the ACIM should be sent to David S. de la Cruz, using the
email address above at least 3 business days prior to the meeting.
Public participants may submit written statements in advance of the
scheduled meeting by emailing [email protected]. Oral comments will be
honored in the order they are requested and may be limited as time
allows.
Individuals who plan to attend and need special assistance or
another reasonable accommodation should notify David S. de la Cruz at
the contact information listed above at least 10 business days prior to
the meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-18565 Filed 8-24-20; 8:45 am]
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