National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 53968 [2021-21131]
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Federal Register / Vol. 86, No. 186 / Wednesday, September 29, 2021 / Notices
The purpose of this draft guidance is
to assist sponsors in the clinical
development of drugs for the treatment
of NTM–PD caused by MAC.
Specifically, this guidance addresses
FDA’s current thinking regarding
clinical trial design issues, choice of
study population, and endpoints for the
treatment of naı¨ve and refractory NTM–
PD caused by MAC.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Nontuberculous Mycobacterial
Pulmonary Disease Caused by
Mycobacterium avium Complex:
Developing Drugs for Treatment.’’ 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.
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 for submissions of
investigational new drug applications,
new drug applications and biologic
license applications in 21 CFR part 312,
part 314 and part 601 have been
approved under OMB control numbers
0910–0014, 0910–0001, and 0910–0338,
respectively.
III. Electronic Access
lotter on DSK11XQN23PROD with NOTICES1
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may obtain the draft guidance at either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: September 23, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21115 Filed 9–28–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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
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: Microbiology,
Infectious Diseases and AIDS Initial Review
Group; Microbiology and Infectious Diseases
B Research Study Section.
Date: October 13–14, 2021.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F30,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Ellen S. Buczko, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3F30, Rockville, MD
20852, 301–451–2676, ebuczko1@
niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: September 23, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–21131 Filed 9–28–21; 8:45 am]
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
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 Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Tropical Medicine Research
Centers Coordinating Center (U01 Clinical
Trial Not Allowed).
Date: October 14, 2021.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G62A,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Eleazar Cohen, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G62A, Rockville, MD
20852, (240) 669–5081, ecohen@
niaid.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: September 23, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–21129 Filed 9–28–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
BILLING CODE 4140–01–P
National Eye Institute; Notice of Closed
Meetings
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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,
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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.
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[Federal Register Volume 86, Number 186 (Wednesday, September 29, 2021)]
[Notices]
[Page 53968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21131]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; 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 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: Microbiology, Infectious Diseases and AIDS
Initial Review Group; Microbiology and Infectious Diseases B
Research Study Section.
Date: October 13-14, 2021.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3F30,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Ellen S. Buczko, Ph.D., Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities, National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3F30,
Rockville, MD 20852, 301-451-2676, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: September 23, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-21131 Filed 9-28-21; 8:45 am]
BILLING CODE 4140-01-P
