National Heart, Lung, and Blood Institute; Notice of Closed Meetings, 11924-11925 [2017-03704]
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Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Notices
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read the electronic and written/paper
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lori
Benner and/or Jessica Barnes, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6221,
Silver Spring, MD 20993–0002, 301–
796–1300.
SUPPLEMENTARY INFORMATION: FDA is
announcing a public workshop
regarding animal model development
for infectious diseases. FDA is
conducting this workshop in order to
facilitate the development of narrowspectrum antibacterial drugs, such as
those that are active against only a
single species of bacteria that may not
occur frequently. When the species
occurs infrequently, performing clinical
trials can be extremely challenging.
Therefore, animal models of infection
may be useful to explore the activity of
a candidate antibacterial drug and may
help to predict whether the drug will be
efficacious in humans. A discussion of
the additional scientific work needed to
evaluate current animal models of
infection and evaluate potential animal
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models that may predict response in
humans could advance the development
of antibacterial drugs targeting a single
species.
FDA is particularly interested in
infections due to Acinetobacter
baumannii and Pseudomonas
aeruginosa as pathogens because there
are limited therapeutic options to treat
patients with serious infections caused
by these bacteria, including those
resistant to currently available
antibacterial drugs. In addition, it is
difficult to enroll an adequate number of
patients to conduct clinical trials since
the frequency with which these
organisms cause clinical disease is
sufficiently low. Discussions will focus
on the current state of animal models of
serious infections, lessons learned from
the development efforts for past and
current animal models of infection, and
scientific challenges and future
direction and next steps in animal
model development.
This public workshop is intended to
provide information for and gain
perspective from health care providers,
other U.S. Government Agencies,
academic experts, contract research
organizations, and industry on various
aspects of development efforts
pertaining to animal models of serious
infections. The input from this public
workshop will also help FDA in
developing topics for future discussion.
The Agency encourages health care
providers, other U.S. Government
Agencies, academic experts, contract
research organizations, industry, and
other interested persons to attend this
public workshop.
Registration: Interested parties are
encouraged to register early. To register
electronically, email registration
information (including name, title, firm
name, address, telephone, and fax
number) to AnimalModelsInfection
Workshop2017@fda.hhs.gov. Persons
without access to the Internet can call
301–796–1300 to register. Registration is
free and will be on a first-come, firstserved basis. However, FDA may limit
the number of participants from each
organization based on space limitations.
Registrants will receive confirmation
once they have been accepted. Onsite
registration on the day of the meeting
will be based on space availability.
If you need special accommodations
due to a disability, please contact Jessica
Barnes or Lori Benner (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present during a
public comment session, and which
topic(s) you wish to address. We will do
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our best to accommodate requests to
make public comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and request time for a
joint presentation. All requests to make
oral presentations must be received by
February 27, 2017. We will determine
the amount of time allotted to each
presenter and the approximate time
each oral presentation is to begin, and
will select and notify participants on or
before February 28, 2017. If selected for
presentation, any presentation materials
must be emailed to AnimalModels
InfectionWorkshop2017@fda.hhs.gov no
later than February 28, 2017. No
commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. The
Freedom of Information office address is
available on the Agency’s Web site at
https://www.fda.gov. Transcripts will
also be available on the Internet at:
https://www.fda.gov/Drugs/NewsEvents/
ucm534031.htm approximately 45 days
after the workshop.
Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–03751 Filed 2–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
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 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
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Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Notices
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
NHLBI Clinical Trial Pilot Studies (R34).
Date: March 17, 2017.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: YingYing Li-Smerin, MD,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7184, Bethesda, MD 20892–
7924, 301–827–7942, lismerin@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Collaborative Projects in Organ Fibrosis.
Date: March 21, 2017.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott, 5520
Wisconsin Avenue, Chevy Chase, MD 20815.
Contact Person: Kristen Page, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, National Institutes of Health,
6701 Rockledge Drive, Room 7185, Bethesda,
MD 20892, 301–827–7953, kristen.page@
nih.gov.
(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: February 21, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–03704 Filed 2–24–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK3G9T082PROD with NOTICES
National Library of Medicine; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of a meeting of the Board
of Scientific Counselors, National
Center for Biotechnology Information.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
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The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for review, discussion, and evaluation of
individual intramural programs and
projects conducted by the NATIONAL
LIBRARY OF MEDICINE, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, National Center for
Biotechnology Information.
Date: May 2, 2017.
Open: 8:30 a.m. to 12:00 p.m.
Agenda: Program Discussion.
Place: National Library of Medicine,
Building 38, 2nd Floor, The Lindberg Room,
8600 Rockville Pike, Bethesda, MD 20892.
Closed: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Library of Medicine,
Building 38, 2nd Floor, The Lindberg Room,
8600 Rockville Pike, Bethesda, MD 20892.
Open: 2:00 p.m. to 3:00 p.m.
Agenda: Program Discussion.
Place: National Library of Medicine,
Building 38, 2nd Floor, The Lindberg Room,
8600 Rockville Pike, Bethesda, MD 20892.
Contact Person: David J. Lipman, MD,
Director, National Center for Biotechnology
Information, National Library of Medicine,
Building 38A, Room 8N805, Bethesda, MD
20892, 301–435–5985, dlipman@
mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
Assistance, National Institutes of Health,
HHS)
Dated: February 21, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–03702 Filed 2–24–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; 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 Institute of
General Medical Sciences Special Emphasis
Panel Review of U54 Application.
Date: March 30, 2017.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: Lisa A. Dunbar, Scientific
Review Officer, Office of Scientific Review,
National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN12, Bethesda, MD
20892, 301–594–2849, dunbarl@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives; 93.859,
Biomedical Research and Research Training,
National Institutes of Health, HHS)
Dated: February 22, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–03822 Filed 2–24–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Sickle
Cell Disease Advisory Committee.
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Agencies
[Federal Register Volume 82, Number 37 (Monday, February 27, 2017)]
[Notices]
[Pages 11924-11925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03704]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed
Meetings
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
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
[[Page 11925]]
would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Heart, Lung, and Blood Institute
Special Emphasis Panel; NHLBI Clinical Trial Pilot Studies (R34).
Date: March 17, 2017.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: YingYing Li-Smerin, MD, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room 7184, Bethesda, MD
20892-7924, 301-827-7942, lismerin@nhlbi.nih.gov.
Name of Committee: National Heart, Lung, and Blood Institute
Special Emphasis Panel; Collaborative Projects in Organ Fibrosis.
Date: March 21, 2017.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Courtyard by Marriott, 5520 Wisconsin Avenue, Chevy
Chase, MD 20815.
Contact Person: Kristen Page, Ph.D., Scientific Review Officer,
Office of Scientific Review/DERA, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701 Rockledge Drive, Room
7185, Bethesda, MD 20892, 301-827-7953, kristen.page@nih.gov.
(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: February 21, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-03704 Filed 2-24-17; 8:45 am]
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