National Institute on Drug Abuse; Notice of Closed Meeting, 42102-42103 [2010-17672]
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Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices
Assistance, National Institutes of Health,
HHS).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 13, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
National Institutes of Health
National Library of Medicine; Notice of
Meeting
[FR Doc. 2010–17675 Filed 7–19–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine; Notice of
Closed Meeting
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of a meeting of the
Biomedical Library and Informatics
Review Committee.
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 materials,
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: Biomedical Library
and Informatics Review Committee.
Date: November 4–5, 2010.
Time: November 4, 2010, 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Library of Medicine,
Building 38, 2nd Floor, Board Room, 8600
Rockville Pike, Bethesda, MD 20892.
Time: November 5, 2010, 8 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Contact Person: Arthur A. Petrosian, PhD,
Chief Scientific Review Officer, Division of
Extramural Programs, National Library of
Medicine, 6705 Rockledge Drive, Suite 301,
Bethesda, MD 20892–7968. 301–496–4253.
petrosia@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
Assistance, National Institutes of Health,
HHS)
Dated: July 13, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–17673 Filed 7–19–10; 8:45 am]
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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.
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 Technology.
Date: November 9, 2010.
Open: 8:30 a.m. to 12 p.m.
Agenda: Program Discussion.
Place: National Library of Medicine,
Building 38, 2nd Floor, Board Room, 8600
Rockville Pike, Bethesda, MD 20892.
Closed: 12 p.m. to 2 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, Board Room, 8600
Rockville Pike, Bethesda, MD 20892.
Open: 2 p.m. to 3 p.m.
Agenda: Program Discussion.
Place: National Library of Medicine,
Building 38, 2nd Floor, Board Room, 8600
Rockville Pike, Bethesda, MD 20892.
Contact Person: David J. Lipman, MD,
Director, National Center of Biotechnology
Information, National Library of Medicine,
Department of Health and Human Services,
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.
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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: July 13, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–17671 Filed 7–19–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel,
Research Dissemination (1143).
Date: August 17–18, 2010.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Courtyard by Marriott Rockville,
2500 Research Boulevard, Rockville, MD
20850.
Contact Person: Lyle Furr, Contract Review
Specialist, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, Room 220, MSC 8401, 6101 Executive
Boulevard, Bethesda, MD 20892–8401. (301)
435–1439, lf33c.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
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Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices
Dated: July 14, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–17672 Filed 7–19–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0364]
Advancing the Development of Medical
Products Used In the Prevention,
Diagnosis, and Treatment of Neglected
Tropical Diseases; Public Hearing
AGENCY:
Food and Drug Administration,
HHS.
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ACTION: Notice of public hearing;
request for comment.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public hearing to solicit general views
and information from interested persons
on issues related to advancing the
development of medical products
(drugs, biological products, and medical
devices) used in the prevention,
diagnosis, and treatment of neglected
tropical diseases. In particular, FDA is
seeking these views and information
from interested persons on preclinical
studies, trial design, regulatory
approaches, and optimal solutions as
they relate to the prevention, diagnosis,
and treatment of neglected tropical
diseases. To help solicit such views and
information, FDA is seeking comments
on specific issues (see section IV of this
document).
DATES: Public Hearing: The public
hearing will be held on September 22,
2010, from 9 a.m. to 5 p.m. However,
depending on the level of public
participation, the meeting may extend
later or end early.
Registration: Interested parties are
encouraged to register early.
Registration is free. Seating will be
available on a first-come, first-served
basis. To register, e-mail your name,
title, firm name, address, and telephone
numbers to
NeglectedDiseasesMtg@fda.hhs.gov or
call Ann Staten at 301–796–8504 by
September 17, 2010.
Registration on the day of the public
hearing will be provided on a spaceavailable basis beginning at 7:30 a.m. To
allow sufficient time for parking and
clearance through security, we
recommend arriving early. See section I
of the SUPPLEMENTARY INFORMATION
section for information on how to
participate in the meeting. If you need
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special accommodations due to a
disability, please contact Ann Staten
(see FOR FURTHER INFORMATION CONTACT)
at least 7 days in advance.
Notice of Participation and
Comments: Submit written or electronic
notices of participation and comments
by September 1, 2010. The
administrative record of the hearing will
remain open to receive additional
comments until October 20, 2010.
ADDRESSES: Public Hearing: The public
hearing will be held at 10903 New
Hampshire Ave., Bldg. 31, rm. 1503 (the
Great Room), Silver Spring, MD 20993.
You must enter through Bldg. 1 and the
security check-point to reach Bldg. 31.
Additional information on parking may
be accessed at https://www.fda.gov/
AboutFDA/WorkingatFDA/Buildingsand
Facilities/WhiteOakCampus
Information/default.htm.
Notice of Participation and
Comments: Submit notices of
participation and comments, identifying
the agency and Docket No. FDA–2010–
N–0364, by any of the following
methods:
Electronic Submissions
Submit electronic notices of
participation and comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for making submissions.
Written Submissions
Submit written notices of
participation and comments in the
following ways:
• Fax: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Ann
M. Staten, Office of Critical Path
Programs, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg., 32, rm. 4106, Silver Spring,
MD 20993–0002, 301–796–8504,
Ann.Staten@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. How to Participate in the Meeting
The procedures governing the hearing
are set forth in part 15 (21 CFR part 15)
of FDA’s regulations. If you wish to
make an oral presentation during the
hearing, you must submit a written
notice of participation (see ADDRESSES)
by September 1, 2010. In the written
notice, submit your name, title, business
affiliation, address, telephone number,
and e-mail address. You should also
submit a written statement for each
issue in section IV of this document that
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you intend to address, and other
pertinent information related to the
topic in your presentation, the names
and addresses of all individuals who
plan to participate, and the approximate
time requested for your presentation.
We encourage individuals and
organizations with common interests to
consolidate or coordinate their
presentations to allow adequate time for
each request for presentation.
Participants should submit to the docket
a copy of each presentation.
We will file the hearing schedule
indicating the order of presentation and
the time allotted to each person to the
docket. We will also e-mail or telephone
the schedule to each participant before
the hearing. In anticipation of the
hearing presentations moving ahead of
schedule, participants are encouraged to
arrive early to ensure their designated
order of presentation. Participants who
are not present when called risk
forfeiting their scheduled time.
II. Background
Approximately one billion people
worldwide suffer from neglected
tropical diseases, e.g., malaria,
tuberculosis, and schistosomiasis.
Developing medical products to
prevent, diagnose, and treat neglected
tropical diseases has not met global
public health needs due to an array of
challenges. To encourage the
development of these much needed
medical products, section 740 of the
Agriculture, Rural Development, Food
and Drug Administration, and Related
Agencies Appropriation Act of 2010
(Public Law 111–80) directs FDA to
establish a review group to recommend
to the Commissioner of Food and Drugs
(the Commissioner) appropriate
preclinical studies, trial design,
regulatory approaches, and optimal
solutions to encourage the development
of medical products to prevent,
diagnose, and treat neglected tropical
diseases of the developing world.
III. Purpose and Scope of the Hearing
The purpose of this public hearing is
to provide advocates for patients with
neglected tropical diseases, academics,
health care providers, the
pharmaceutical and medical device
industries, and other interested parties
an opportunity to address specific
topics (see section IV of this document)
and present to FDA their views,
recommendations, and any other
pertinent information related to the
scope of this public hearing. This
information will assist the FDA review
group in making recommendations to
the Commissioner regarding appropriate
preclinical studies, trial design,
E:\FR\FM\20JYN1.SGM
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Agencies
[Federal Register Volume 75, Number 138 (Tuesday, July 20, 2010)]
[Notices]
[Pages 42102-42103]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17672]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse; 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 contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable materials, and personal information concerning individuals
associated with the contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel, Research Dissemination (1143).
Date: August 17-18, 2010.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate contract proposals.
Place: Courtyard by Marriott Rockville, 2500 Research Boulevard,
Rockville, MD 20850.
Contact Person: Lyle Furr, Contract Review Specialist, Office of
Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS,
Room 220, MSC 8401, 6101 Executive Boulevard, Bethesda, MD 20892-
8401. (301) 435-1439, lf33c.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug
Abuse and Addiction Research Programs, National Institutes of
Health, HHS)
[[Page 42103]]
Dated: July 14, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-17672 Filed 7-19-10; 8:45 am]
BILLING CODE 4140-01-P