National Institute on Drug Abuse; Notice of Closed Meetings, 6878-6879 [2022-02469]
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Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices
guidance, when finalized, will describe
procedures under which meeting
requesters can meet with appropriate
FDA officials to obtain
recommendations on the studies and
other information necessary to support
submissions under section 505G of the
FD&C Act, to obtain information on
other matters relevant to the regulation
of nonprescription drugs, and to obtain
recommendations on the development
of new OTC monograph drugs. As
required by section 505G(i) of the FD&C
Act, this draft guidance, when finalized,
will also describe procedures to
facilitate efficient participation in joint
meetings by multiple meeting requestors
and/or organizations nominated by
them to represent their interests.
This draft guidance does not apply to
meetings for the development of
nonprescription drug products intended
for submission in new drug applications
or abbreviated new drug applications
under section 505 of the FD&C Act. This
draft guidance does not apply to
meetings between FDA and preinvestigational new drug or
investigational new drug sponsors. For
the purposes of this draft guidance, a
formal meeting includes any meeting
that is requested by a meeting requester
following the procedures provided in
this draft guidance and includes
meetings conducted in any format (i.e.,
face to face, teleconference/
videoconference, or written response
only).
In support of the CARES Act, FDA
agreed to specific performance goals and
procedures described in the document
‘‘Over-the-Counter Monograph User Fee
Program Performance Goals and
Procedures—Fiscal Years 2018–2022,’’
commonly referred to as the OMUFA
Commitment Letter (the document can
be accessed at https://www.fda.gov/
media/106407/download and the
document with updated goal dates for
fiscal years 2021–2025 can be accessed
at https://www.fda.gov/media/146283/
download). The OMUFA Commitment
Letter includes meeting management
goals for formal meetings that occur
between FDA and meeting requesters. In
the OMUFA Commitment Letter, FDA
committed to issuing this draft guidance
under specific timelines.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Formal Meetings Between FDA and
Sponsors or Requestors of Over-theCounter Monograph Drugs; Draft
Guidance for Industry.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
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You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
Under section 505G(o) of the FD&C
Act, the Paperwork Reduction Act of
1995 does not apply to collections of
information made under section 505G of
the FD&C Act. The information
collections made in this guidance
implement the provisions of three
subsections of section 505G: (1) Section
505G(l)(1), which requires FDA to issue
guidance that specifies the procedures
and principles for formal meetings
between FDA and sponsors or
requestors for drugs subject to section
505G; (2) section 505G(h), which
requires FDA to establish procedures
under which meeting requestors can
meet with appropriate FDA officials to
obtain advice on the studies and other
information necessary to support
submissions under section 505G, other
matters relevant to the regulation of
nonprescription drugs, and the
development of new nonprescription
drugs under section 505G; and (3)
section 505G(i), which requires FDA to,
among other things, establish
procedures to facilitate efficient
participation in joint meetings by
multiple meeting requesters and/or
organizations nominated by them to
represent their interests. Therefore,
clearance by the Office of Management
and Budget under the Paperwork
Reduction Act of 1995 is not required
for these collections of information.
III. 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/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: February 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–02446 Filed 2–4–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
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.
PO 00000
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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 and the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; NIH
Support for Conferences and Scientific
Meetings.
Date: March 4, 2022.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Gerald L. McLaughlin,
Ph.D., Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, NIH, 301 North
Stonestreet Avenue, MSC 6021, Bethesda,
MD 20892, (301) 827–5819, gm145a@nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
Fentanyl and its Analogs: Effects and
Consequences for Treatment of Addiction
and Overdose (UG3/UH3 Clinical Trial
Optional).
Date: March 9, 2022.
Time: 9:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Preethy Nayar, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Drug Abuse,
NIH, 301 North Stonestreet Avenue, MSC
6021, Bethesda, MD 20892, 301–443–4577,
nayarp2@csr.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; SEP for
Centers Review.
Date: March 9, 2022.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Sheila Pirooznia, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Drug Abuse,
NIH, 301 North Stonestreet Avenue, MSC
6021, Bethesda, MD 20892, (301) 496–9350,
sheila.pirooznia@nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; for
Avenir Review.
Date: March 21, 2022.
Time: 3:00 p.m. to 4:00 p.m.
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Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Ipolia R. Ramadan, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, NIH, 301 North
Stonestreet Avenue, MSC 6021, Bethesda,
MD 20892, (301) 827–4471, ramadanir@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.277, Drug Abuse Scientist
Development Award for Clinicians, Scientist
Development Awards, and Research Scientist
Awards; 93.278, Drug Abuse National
Research Service Awards for Research
Training; 93.279, Drug Abuse and Addiction
Research Programs, National Institutes of
Health, HHS)
Dated: February 1, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–02469 Filed 2–4–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
jspears on DSK121TN23PROD with NOTICES1
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/or contract proposals 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 and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; A
Multilevel Approach to Connecting
Underrepresented Populations to Clinical
Trials (CUSP2CT).
Date: March 9, 2022.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W140, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: David G. Ransom, Ph.D.,
Chief, Scientific Review Officer, Special
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Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W140,
Rockville, Maryland 20850, 240–276–6351,
david.ransom@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; The Role of
Epstein Barr Virus (EBV) Infection in NonHodgkin Lymphoma (NHL) and Hodgkin
Disease (HD) Development with or without
an Underlying HIV Infection (U01).
Date: March 24, 2022.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W104, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Robert F. Gahl, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9606 Medical
Center Drive, Room 7W104, Rockville,
Maryland 20850, 240–276–7869, robert.gahl@
nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; R13
Conference Grant Review.
Date: March 24, 2022.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W552, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Jeanette Irene Marketon,
Ph.D., Scientific Review Officer, Program
Coordination and Referral Branch, Division
of Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W552, Rockville, Maryland 20850,
240–276–6780, jeanette.marketon@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; TEP–11:
SBIR Contract Review Meeting.
Date: March 31, 2022.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W126, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Susan Lynn Spence, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W126, Rockville, Maryland
20850, 240–620–0819, susan.spence@
nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Cancer
Center Support Grant.
Date: May 12, 2022.
Time: 2:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W612, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: CAPT Shari Williams
Campbell, DPM, MSHS, Scientific Review
PO 00000
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Officer, Resources and Training Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, Room 7W612, Rockville,
Maryland 20850, 240–276–7381,
shari.campbell@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: February 2, 2022.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–02476 Filed 2–4–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Pitts, Ph.D., 240–669–5299;
elizabeth.pitts@nih.gov. Licensing
information and copies of the patent
applications listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD 20852; tel.
301–496–2644. A signed Confidential
Disclosure Agreement may be required
to receive any unpublished information.
SUPPLEMENTARY INFORMATION:
Technology description follows:
SUMMARY:
Monoclonal Antibodies To Prevent or
Treat SARS–CoV–2 Infection
Description of Technology
The ongoing COVID–19 pandemic,
caused by severe respiratory syndrome
coronavirus 2 (SARS–CoV–2), has
E:\FR\FM\07FEN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 25 (Monday, February 7, 2022)]
[Notices]
[Pages 6878-6879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02469]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse; 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 and the disclosure of which
would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel; NIH Support for Conferences and Scientific Meetings.
Date: March 4, 2022.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, National Institute on Drug
Abuse, 301 North Stonestreet Avenue, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Gerald L. McLaughlin, Ph.D., Scientific Review
Officer, Office of Extramural Policy and Review, National Institute
on Drug Abuse, NIH, 301 North Stonestreet Avenue, MSC 6021,
Bethesda, MD 20892, (301) 827-5819, [email protected].
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel; Fentanyl and its Analogs: Effects and Consequences
for Treatment of Addiction and Overdose (UG3/UH3 Clinical Trial
Optional).
Date: March 9, 2022.
Time: 9:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, National Institute on Drug
Abuse, 301 North Stonestreet Avenue, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Preethy Nayar, Ph.D., Scientific Review Officer,
Scientific Review Branch, National Institute on Drug Abuse, NIH, 301
North Stonestreet Avenue, MSC 6021, Bethesda, MD 20892, 301-443-
4577, [email protected].
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel; SEP for Centers Review.
Date: March 9, 2022.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, National Institute on Drug
Abuse, 301 North Stonestreet Avenue, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Sheila Pirooznia, Ph.D., Scientific Review
Officer, Scientific Review Branch, National Institute on Drug Abuse,
NIH, 301 North Stonestreet Avenue, MSC 6021, Bethesda, MD 20892,
(301) 496-9350, [email protected].
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel; for Avenir Review.
Date: March 21, 2022.
Time: 3:00 p.m. to 4:00 p.m.
[[Page 6879]]
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, National Institute on Drug
Abuse, 301 North Stonestreet Avenue, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Ipolia R. Ramadan, Ph.D., Scientific Review
Officer, Office of Extramural Policy and Review, National Institute
on Drug Abuse, NIH, 301 North Stonestreet Avenue, MSC 6021,
Bethesda, MD 20892, (301) 827-4471, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.277, Drug
Abuse Scientist Development Award for Clinicians, Scientist
Development Awards, and Research Scientist Awards; 93.278, Drug
Abuse National Research Service Awards for Research Training;
93.279, Drug Abuse and Addiction Research Programs, National
Institutes of Health, HHS)
Dated: February 1, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2022-02469 Filed 2-4-22; 8:45 am]
BILLING CODE 4140-01-P
