80 FR 65783 - National Heart, Lung, and Blood Institute Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 207 (October 27, 2015)

Page Range		65783-65783
FR Document		2015-27325

Federal Register, Volume 80 Issue 207 (Tuesday, October 27, 2015)

[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Page 65783]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27325]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute Notice of Closed 
Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), 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: National Heart, Lung, and Blood Institute, 
Special Emphasis Panel; T32 Training Program for Institutions that 
Promote Diversity.
    Date: November 16, 2015.
    Time: 2:30 p.m. to 3:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, Room 
7189, Bethesda, MD 20892, (Telephone Conference Call).
    Contact Person: Stephanie L Constant, Ph.D., Scientific Review 
Officer, Office of Scientific Review/DERA, National Heart, Lung, and 
Blood Institute, 6701 Rockledge Drive, Room 7189, Bethesda, MD 
20892, 301-443-8784, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.233, 
National Center for Sleep Disorders Research; 93.837, Heart and 
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, 
Blood Diseases and Resources Research, National Institutes of 
Health, HHS)

    Dated: October 22, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-27325 Filed 10-26-15; 8:45 am]
BILLING CODE 4140-01-P

Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices 65783

which FDA does not intend to object to DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
the compounding of a drug product HUMAN SERVICES as amended. The grant applications and
from certain bulk drug substances by an the discussions could disclose
outsourcing facility while FDA develops National Institutes of Health confidential trade secrets or commercial
the list of bulk drug substances that can property such as patentable material,
National Heart, Lung, and Blood and personal information concerning
be used in compounding under section
Institute Notice of Closed Meeting individuals associated with the grant
503B(a)(2)(A)(i) of the FD&C Act.
Pursuant to section 10(d) of the applications, the disclosure of which
The final guidance ‘‘Pharmacy would constitute a clearly unwarranted
Compounding of Human Drug Products Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is invasion of personal privacy.
Under Section 503A of the FD&C Act,’’
hereby given of the following meeting. Name of Committee: National Eye Institute
(503A Final Guidance) published in The meeting will be closed to the Special Emphasis Panel; NEI Clinical and
2014 (79 FR 37742; July 2, 2014), states, public in accordance with the Epidemiological Applications: Retina,
‘‘Until a bulk drug substances list is provisions set forth in sections Glaucoma and Neuro-Ophthalmology.
published in the Federal Register as a 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Date: December 10, 2015.
final rule, human drug products should Time: 8:30 a.m. to 4:00 p.m.
as amended. The grant applications and
be compounded using only bulk drug Agenda: To review and evaluate grant
the discussions could disclose applications.
substances that are components of drugs confidential trade secrets or commercial Place: Embassy Suites at the Chevy Chase
approved under section 505 of the FD&C property such as patentable material, Pavilion, 4300 Military Road NW.,
Act, or are the subject of USP or NF and personal information concerning Washington, DC 20015.
monographs.’’ Because this draft interim individuals associated with the grant Contact Person: Brian Hoshaw, Ph.D.,
guidance proposes to change the applications, the disclosure of which Scientific Review Officer, National Eye
would constitute a clearly unwarranted Institute, National Institutes of Health,
Agency’s policy relating to
Division of Extramural Research, 5635
compounding with bulk drug invasion of personal privacy. Fishers Lane, Suite 1300, Rockville, MD
substances while FDA develops a list of Name of Committee: National Heart, Lung, 20892, 301–451–2020, hoshawb@
bulk drug substances that can be used and Blood Institute, Special Emphasis Panel; mail.nih.gov.
in compounding, FDA is adding a T32 Training Program for Institutions that (Catalogue of Federal Domestic Assistance
footnote to the 503A Final Guidance Promote Diversity. Program Nos. 93.867, Vision Research,
Date: November 16, 2015. National Institutes of Health, HHS)
referencing this draft interim guidance. Time: 2:30 p.m. to 3:30 p.m.
Once this draft interim guidance is Agenda: To review and evaluate grant Dated: October 22, 2015.
finalized, FDA intends to remove that applications. Natasha Copeland,
footnote from the 503A Final Guidance Place: National Institutes of Health, 6701 Program Analyst, Office of Federal Advisory
and cross-reference the final interim Rockledge Drive, Room 7189, Bethesda, MD Committee Policy.
guidance as establishing the policy for 20892, (Telephone Conference Call). [FR Doc. 2015–27324 Filed 10–26–15; 8:45 am]
Contact Person: Stephanie L Constant,
compounding with bulk drug Ph.D., Scientific Review Officer, Office of BILLING CODE 4140–01–P
substances during the development of Scientific Review/DERA, National Heart,
the 503A bulks list. The footnote is Lung, and Blood Institute, 6701 Rockledge
being added to the 503A Final Guidance Drive, Room 7189, Bethesda, MD 20892, 301– DEPARTMENT OF HEALTH AND
as a Level 2 change under 21 CFR 443–8784, constantsl@nhlbi.nih.gov. HUMAN SERVICES
10.115 because the final interim (Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for National Institutes of Health
guidance, rather than the footnote to the Sleep Disorders Research; 93.837, Heart and
503A Final Guidance, will set forth the Vascular Diseases Research; 93.838, Lung National Institute of Allergy and
actual change in policy. Accordingly, Diseases Research; 93.839, Blood Diseases Infectious Diseases Notice of Closed
comments on the proposed change in and Resources Research, National Institutes Meeting
policy are being solicited as part of this of Health, HHS)
Pursuant to section 10(d) of the
Notice of Availability on the draft Dated: October 22, 2015.
Federal Advisory Committee Act, as
interim guidance. Michelle Trout, amended (5 U.S.C. App.), notice is
Program Analyst, Office of Federal Advisory hereby given of the following meeting.
II. Electronic Access
Committee Policy. The meeting will be closed to the
Persons with access to the Internet [FR Doc. 2015–27325 Filed 10–26–15; 8:45 am] public in accordance with the
may obtain the guidance at either BILLING CODE 4140–01–P provisions set forth in sections
http://www.fda.gov/Drugs/ 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
GuidanceCompliance as amended. The grant applications and
RegulatoryInformation/Guidances/ DEPARTMENT OF HEALTH AND the discussions could disclose
default.htm or http:// HUMAN SERVICES confidential trade secrets or commercial
www.regulations.gov. property such as patentable material,
National Institutes of Health
and personal information concerning
Dated: October 21, 2015.
National Eye Institute Notice of Closed individuals associated with the grant
Leslie Kux, applications, the disclosure of which
Meeting
Associate Commissioner for Policy. would constitute a clearly unwarranted
tkelley on DSK3SPTVN1PROD with NOTICES

[FR Doc. 2015–27269 Filed 10–26–15; 8:45 am] Pursuant to section 10(d) of the invasion of personal privacy.
Federal Advisory Committee Act, as
BILLING CODE 4164–01–P Name of Committee: National Institute of
amended (5 U.S.C. App.), notice is Allergy and Infectious Diseases Special
hereby given of the following meeting. Emphasis Panel; NIAID Clinical Trial
The meeting will be closed to the Implementation Cooperative Agreement
public in accordance with the (U01).
provisions set forth in sections Date: November 24, 2015.

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Document Created: 2015-12-14 15:36:33
Document Modified: 2015-12-14 15:36:33

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		November 16, 2015.
FR Citation		80 FR 65783

80 FR 65783 - National Heart, Lung, and Blood Institute Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 207 (October 27, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health