National Center for Advancing Translational Sciences; Notice of Closed Meeting, 4671-4672 [2020-01258]
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Federal Register / Vol. 85, No. 17 / Monday, January 27, 2020 / Notices
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911; or Ei Thu Lwin, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6236,
Silver Spring, MD 20993–0002, 301–
796–0728.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December
20, 2019 (84 FR 70196), FDA published
a notice with a 60-day comment period
to request comments on the draft
guidance for industry entitled
‘‘Demonstrating Substantial Evidence of
Effectiveness for Human Drug and
Biological Products.’’ The Agency has
received requests for extension of the
comment period. The requests conveyed
that additional time is needed to
provide comments. FDA has considered
the requests and is extending the
comment period for 30 days, until
March 19, 2020. The Agency believes
that an additional 30 days will allow
adequate time for interested persons to
submit comments without
compromising the timely publication of
the final version of the guidance.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https://
www.regulations.gov.
Dated: January 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01322 Filed 1–24–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on HIV/AIDS
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
khammond on DSKJM1Z7X2PROD with NOTICES
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Service is hereby giving notice that the
Presidential Advisory Council on HIV/
AIDS (PACHA or the Council) will be
holding the 66th full Council meeting in
SUMMARY:
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Washington, DC. Agenda items will
include: Discussion of Ending the HIV
Epidemic: A Plan for America (EHE)
Jurisdictional Plans, Focusing on the
Four Pilot Sites: DeKalb County,
Georgia; Baltimore, Maryland; East
Baton Rouge, Louisiana; and the
Cherokee Nation of Oklahoma; the
Ready, Set, PrEP National Program;
Stigma as a Barrier—Shared Experiences
and Challenges from International and
Domestic Perspectives; and Women and
HIV. The meeting will be open to the
public; a public comment session will
be held during the meeting. Preregistration is encouraged for members
of the public who wish to attend the
meeting and who wish to participate in
the public comment session. Individuals
who wish to attend the meeting and/or
send in their public comment via email
should send an email to PACHA@
hhs.gov. Pre-Registration must be
complete by Monday, February 3, 2020.
DATES: The Council meeting is
scheduled to convene on Monday,
February 10, 2020 from approximately
1:00 p.m. to 7:00 p.m. ET and Tuesday,
February 11, 2020 from approximately
9:00 a.m. to 5:00 p.m. ET (times are
tentative and subject to change). The
meeting agenda will be posted on the
PACHA web page at https://
www.hiv.gov/federal-response/pacha/
about-pacha. Public attendance is
limited to available space.
ADDRESSES: Grand Hyatt Washington,
1000 H Street NW, Washington, DC
20001.
FOR FURTHER INFORMATION CONTACT: Ms.
Caroline Talev, MPA, Public Health
Analyst, Presidential Advisory Council
on HIV/AIDS, 330 C Street SW, Room
L609A, Washington, DC 20024; (202)
795–7622 or PACHA@hhs.gov.
Additional information can be obtained
by accessing the Council’s page on the
HIV.gov site at www.hiv.gov/pacha.
SUPPLEMENTARY INFORMATION: PACHA
was established by Executive Order
12963, dated June 14, 1995, as amended
by Executive Order 13009, dated June
14, 1996 and is currently operating
under the authority given in Executive
Order 13889, dated September 27, 2019.
The Council was established to provide
advice, information, and
recommendations to the Secretary
regarding programs and policies
intended to promote effective
prevention and care of HIV infection
and AIDS. The functions of the Council
are solely advisory in nature.
The Council consists of not more than
25 members. Council members are
selected from prominent community
leaders with particular expertise in, or
knowledge of, matters concerning HIV
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and AIDS, public health, global health,
philanthropy, marketing or business, as
well as other national leaders held in
high esteem from other sectors of
society. Council members are appointed
by the Secretary or designee, in
consultation with the White House.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify Caroline
Talev at PACHA@hhs.gov. Due to space
constraints, pre-registration for public
attendance is advisable and can be
accomplished by contacting PACHA@
hhs.gov by close of business Monday,
February 3, 2020. Members of the public
will have the opportunity to provide
comments during the meeting.
Comments will be limited to no more
than three minutes per speaker. Any
individual who wishes to participate in
the public comment session must
register with Caroline Talev at PACHA@
hhs.gov by close of business Monday,
February 3, 2020; registration for public
comment will not be accepted by
telephone. Individuals are encouraged
to provide a written statement of any
public comment(s) for accurate minute
taking purposes. Any members of the
public who wish to have printed
material distributed to PACHA members
at the meeting are asked to submit, at a
minimum, 1 copy of the material(s) to
Caroline Talev, no later than close of
business Monday, February 3, 2020.
Dated: January 15, 2020.
B. Kaye Hayes,
Principal Deputy Director, Office of Infectious
Disease and HIV/AIDS Policy, Executive
Director, Presidential Advisory Council on
HIV/AIDS, Office of the Assistant Secretary
for Health, Department of Health and Human
Services.
[FR Doc. 2020–01336 Filed 1–24–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
Pursuant to section 10(d) 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
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Federal Register / Vol. 85, No. 17 / Monday, January 27, 2020 / Notices
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: National Center for
Advancing Translational Sciences Special
Emphasis Panel; CTSA Collaborative
Innovation Awards Review Meeting.
Date: February 20, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: M. Lourdes Ponce, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Center for Advancing
Translational Sciences (NCATS), National
Institutes of Health, 6701 Democracy Blvd.,
Democracy 1, Room 1073, Bethesda, MD
20892, 301–435–0810, lourdes.ponce@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: January 21, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–01258 Filed 1–24–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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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: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group;
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Integrative Nutrition and Metabolic Processes
Study Section.
Date: February 20–21, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance, Washington, DC Hotel,
999 Ninth Street NW, Washington, DC
20001–4427.
Contact Person: Gregory S. Shelness, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6156,
Bethesda, MD 20892–7892, 301–755–4335,
greg.shelness@nih.gov.
Name of Committee: Molecular, Cellular
and Developmental Neuroscience Integrated
Review Group; Molecular
Neuropharmacology and Signaling Study
Section.
Date: February 20–21, 2020.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Fairmont Washington, DC, 2401
M Street NW, Washington, DC 20037.
Contact Person: Vanessa S. Boyce, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm. 4016F,
MSC 7812, Bethesda, MD 20892, (301) 435–
0908, boycevs@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Chronic Dysfunction and Integrative
Neurodegeneration Study Section.
Date: February 20–21, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Holiday Inn Bayside, 4875 North
Harbor Drive, San Diego, CA 92106.
Contact Person: Jenny R. Browning, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm. 5207,
Bethesda, MD 20892, jenny.browning@
nih.gov.
Name of Committee: Bioengineering
Sciences & Technologies Integrated Review
Group; Biodata Management and Analysis
Study Section.
Date: February 20–21, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The William F. Bolger Center, 9600
Newbridge Drive, Potomac, MD 20854.
Contact Person: Wenchi Liang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3150,
MSC 7770, Bethesda, MD 20892, 301–435–
0681, liangw3@csr.nih.gov.
Name of Committee: Emerging
Technologies and Training Neurosciences
Integrated Review Group; Molecular
Neurogenetics Study Section.
Date: February 20–21, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westgate Hotel, 1055 Second
Avenue, San Diego, CA 92101.
Contact Person: Mary G. Schueler, Ph.D.,
Scientific Review Officer, Center for
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Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5214,
MSC 7846, Bethesda, MD 20892, 301–915–
6301, marygs@csr.nih.gov.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Electrical Signaling, Ion Transport,
and Arrhythmias Study Section.
Date: February 20, 2020.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bahia Resort Hotel, 998 West
Mission, Bay Drive, San Diego, CA 92109.
Contact Person: Sara Ahlgren, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, RM 4136,
Bethesda, MD 20892, 301–435–0904,
sara.ahlgren@nih.gov.
Name of Committee: Risk, Prevention and
Health Behavior Integrated Review Group;
Social Psychology, Personality and
Interpersonal Processes Study Section.
Date: February 20–21, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Le Meridien Delfina Santa Monica,
530 Pico Blvd., Santa Monica, CA 90405.
Contact Person: Marc Boulay, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3110,
MSC 7808, Bethesda, MD 20892, (301) 300–
6541, boulaymg@csr.nih.gov.
Name of Committee: Oncology 2—
Translational Clinical Integrated Review
Group; Developmental Therapeutics Study
Section.
Date: February 20–21, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westgate Hotel, 1055 Second
Avenue, San Diego, CA 92101.
Contact Person: Nicholas J. Donato, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040,
Bethesda, MD 20892, 301–827–4810,
nick.donato@nih.gov.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Myocardial Ischemia and Metabolism
Study Section.
Date: February 20–21, 2020.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard Silver Spring Downtown,
8506 Fenton Street, Silver Spring, MD 20910.
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: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Clinical and Integrative
Cardiovascular Sciences Study Section.
Date: February 20–21, 2020.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
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Agencies
[Federal Register Volume 85, Number 17 (Monday, January 27, 2020)]
[Notices]
[Pages 4671-4672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01258]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Advancing Translational Sciences; Notice of
Closed Meeting
Pursuant to section 10(d) 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
[[Page 4672]]
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: National Center for Advancing Translational
Sciences Special Emphasis Panel; CTSA Collaborative Innovation
Awards Review Meeting.
Date: February 20, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, One Democracy Plaza, 6701
Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: M. Lourdes Ponce, Ph.D., Scientific Review
Officer, Office of Scientific Review, National Center for Advancing
Translational Sciences (NCATS), National Institutes of Health, 6701
Democracy Blvd., Democracy 1, Room 1073, Bethesda, MD 20892, 301-
435-0810, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.859,
Pharmacology, Physiology, and Biological Chemistry Research; 93.350,
B--Cooperative Agreements; 93.859, Biomedical Research and Research
Training, National Institutes of Health, HHS)
Dated: January 21, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-01258 Filed 1-24-20; 8:45 am]
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