National Institute on Drug Abuse; Notice of Closed Meeting, 3913-3914 [2011-1250]
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Federal Register / Vol. 76, No. 14 / Friday, January 21, 2011 / Notices
should always check the Agency’s Web site
and call the appropriate advisory committee
hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: The committee will discuss
innovative approaches to the development of
drugs for orphan and rare diseases to support
decisions such as dose and trial design
selection. FDA will seek input and comment
on how to optimally utilize mechanistic
biomarkers and apply clinical pharmacology
tools, such as pharmacogenetics and
modeling and simulation, to facilitate
efficient and informative drug development
and regulatory review. FDA will present and
seek input from the committee on how
lessons learned from other applications of
clinical pharmacology tools in pediatrics and
oncology can be applied to orphan and rare
disease drugs. The committee will be asked
to comment on the current status and future
direction for clinical pharmacology studies
(e.g., dose-response, drug-drug interactions,
pharmacokinetics in patients with renal or
hepatic impairment) as they pertain to drug
development for orphan and rare diseases.
FDA intends to make background material
available to the public no later than 2
business days before the meeting. If FDA is
unable to post the background material on its
Web site prior to the meeting, the background
material will be made publicly available at
the location of the advisory committee
meeting, and the background material will be
posted on FDA’s Web site after the meeting.
Background material is available at https://
www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate
advisory committee link.
Procedure: Interested persons may present
data, information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
February 15, 2011. Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those
individuals interested in making formal oral
presentations should notify the contact
person and submit a brief statement of the
general nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and an
indication of the approximate time requested
to make their presentation on or before
February 7, 2011. Time allotted for each
presentation may be limited. If the number of
registrants requesting to speak is greater than
can be reasonably accommodated during the
scheduled open public hearing session, FDA
may conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by February 8, 2011.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee meetings
and will make every effort to accommodate
persons with physical disabilities or special
needs. If you require special accommodations
due to a disability, please contact Yvette
Waples, at least 7 days in advance of the
meeting.
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FDA is committed to the orderly conduct
of its advisory committee meetings. Please
visit our Web site at https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for procedures
on public conduct during advisory
committee meetings.
Notice of this meeting is given under the
Federal Advisory Committee Act (5 U.S.C.
app. 2).
Dated: January 18, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–1223 Filed 1–20–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Council on Blood Stem Cell
Transplantation; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Council on Blood
Stem Cell Transplantation.
Date and Time: February 4, 2011,
from 3 p.m. to 5 p.m. EST.
ACTION: Notice of Advisory Council on
Blood Stem Cell Transplantation
(ACBSCT) Meeting to be Held by
Conference Call.
The ACBSCT will be
conducting a conference call to discuss:
(1) Final language of
recommendations from November 15,
2010, Council meeting; and
(2) Interim Report to Congress.
DATES: The conference call will be held
on February 4, 2011, at 3 p.m. to 5 p.m.
EST. Participants must dial: (800) 988–
9536 and enter the corresponding pass
code 2741198. Patricia A. Stroup, MBA,
MPA, is the call leader. Participants
should call no later than 2:50 p.m. EST
in order for the logistics to be set up.
Participants are asked to register for the
conference by contacting Passy Tongele
at (301) 443–0437 or e-mail
ptongele@hrsa.gov. The registration
deadline is February 2, 2011. The
Department will try to accommodate
those wishing to participate in the call.
Any member of the public can submit
written materials that will be distributed
to Council members prior to the
conference call. Parties wishing to
submit written comments should ensure
that the comments are received no later
than February 2, 2011, for
consideration. Comments should be
submitted to Passy Tongele, Healthcare
SUMMARY:
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Systems Bureau, HRSA, Parklawn
Building, Room 12C–06, 5600 Fishers
Lane, Rockville, Maryland 20857;
telephone (301) 443–0437; fax (301)
594–6095; or e-mail to
ptongele@hrsa.gov.
Members of the public can present
oral comments during the conference
call during the public comment period.
If a member of the public wishes to
speak, the Department should be
notified at the time the participant
registers. Others members of the public
will be allocated time if time permits.
FOR FURTHER INFORMATION CONTACT:
Patricia A. Stroup, MBA, MPA,
Executive Secretary, ACBSCT,
Healthcare Systems Bureau, HRSA,
Parklawn Building, Room 12C–06, 5600
Fishers Lane, Rockville, Maryland
20857; telephone (301) 443–1127; fax
(301) 594–6095; or e-mail to
pstroup@hrsa.gov.
The
purpose of this call is to hear discussion
from the ACBSCT members on the final
language of the eight recommendations
approved at the November 15, 2010,
Council meeting and to discuss the
Interim Report to Congress. Public Law
111–264 states that ‘‘* * * the Secretary
of Health and Human Services * * * in
consultation with the Advisory Council
* * * shall submit to Congress an
interim report not later than 180 days
after the date of enactment of this Act
describing (A) the methods to distribute
Federal funds to cord blood banks used
at the time of submission of the report;
(B) how cord blood banks contract with
collection sites for the collection of cord
blood units; and (C) recommendations
for improving the methods to distribute
Federal funds described in
subparagraph (A) in order to encourage
the efficient collection of high-quality
and diverse cord blood units.’’
SUPPLEMENTARY INFORMATION:
Dated: January 14, 2011.
Robert Hendricks,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2011–1266 Filed 1–20–11; 8:45 am]
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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 a meeting of the Board
of Scientific Counselors, NIDA. The
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Federal Register / Vol. 76, No. 14 / Friday, January 21, 2011 / Notices
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 the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute on Drug Abuse,
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, NIDA.
Date: February 11, 2011.
Closed: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: Intramural Research Program,
National Institute on Drug Abuse, NIH, Johns
Hopkins Bayview Campus, Baltimore, MD
21223.
Contact Person: Stephen J. Heishman, PhD,
Research Psychologist, Clinical
Pharmacology Branch, Intramural Research
Program, National Institute on Drug Abuse,
National Institutes of Health, DHHS, 5500
Nathan Shock Drive, Baltimore, MD 21224,
(410) 550–1547.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: January 14, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–1250 Filed 1–20–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Center for Scientific Review; 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
would constitute a clearly unwarranted
invasion of personal privacy.
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Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Tumor Biology and Therapy.
Date: February 1–2, 2011.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Manzoor Zarger, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6208,
MSC 7804, Bethesda, MD 20892. (301) 435–
2477. zargerma@csr.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.
Name of Committee: Molecular, Cellular
and Developmental Neuroscience Integrated
Review Group, Neurodifferentiation,
Plasticity, and Regeneration Study Section.
Date: February 15–16, 2011.
Time: 8 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Holiday Inn San Francisco
Fisherman’s Wharf, 1300 Columbus Avenue,
San Francisco, CA 94133.
Contact Person: Carole L. Jelsema, PhD,
Chief and Scientific Review Officer, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4176,
MSC 7850, Bethesda, MD 20892. (301) 435–
1248. jelsemac@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, PAR–10–
112: Development of Outcome Measures to
Determine Success of Hearing Health Care.
Date: February 18, 2011.
Time: 2 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Baltimore Marriott Waterfront, 700
Aliceanna Street, Baltimore, MD 21202.
Contact Person: Lynn E. Luethke, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5166,
MSC 7844, Bethesda, MD 20892. (301) 806–
3323. luethkel@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, RFA Panel:
Methodology and Measurement in the
Behavioral and Social Sciences.
Date: February 21, 2011.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Ritz Carlton, 1150 22nd Street,
NW., Washington, DC 20037.
Contact Person: Jose H. Guerrier, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892. 301–435–
1137. guerriej@csr.nih.gov.
Name of Committee: Cell Biology
Integrated Review Group, Biology and
Diseases of the Posterior Eye Study Section.
Date: February 22–23, 2011.
Time: 8 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
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Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Michael H. Chaitin, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5202,
MSC 7850, Bethesda, MD 20892. (301) 435–
0910. chaitinm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Nutrition, Metabolism,
Endocrinology and Pregnancy.
Date: February 22–23, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Gary Hunnicutt, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6164,
MSC 7892, Bethesda, MD 20892. 301–435–
0229. gary.hunnicutt@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Chronic
Fatigue Syndrome, Fibromyalgia Syndrome,
Temporomandibular Disorders.
Date: February 22–23, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting.)
Contact Person: Brian Hoshaw, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5181,
MSC 7844, Bethesda, MD 20892. 301–435–
1033. hoshawb@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Vision
Sciences and Technology.
Date: February 22–23, 2011.
Time: 8 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: George Ann McKie, DVM,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5192,
MSC 7846, Bethesda, MD 20892. 301–996–
0993. mckiegeo@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Epidemiology and Genetics of
Cancer.
Date: February 22–23, 2011.
Time: 8 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Fungai Chanetsa, MPH,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3135,
MSC 7770, Bethesda, MD 20892. 301–408–
9436. fungai.chanetsa@nih.hhs.gov.
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Agencies
[Federal Register Volume 76, Number 14 (Friday, January 21, 2011)]
[Notices]
[Pages 3913-3914]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1250]
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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 a meeting of the
Board of Scientific Counselors, NIDA. The
[[Page 3914]]
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 the review, discussion, and evaluation of individual
intramural programs and projects conducted by the National Institute on
Drug Abuse, 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, NIDA.
Date: February 11, 2011.
Closed: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate personal qualifications and
performance, and competence of individual investigators.
Place: Intramural Research Program, National Institute on Drug
Abuse, NIH, Johns Hopkins Bayview Campus, Baltimore, MD 21223.
Contact Person: Stephen J. Heishman, PhD, Research Psychologist,
Clinical Pharmacology Branch, Intramural Research Program, National
Institute on Drug Abuse, National Institutes of Health, DHHS, 5500
Nathan Shock Drive, Baltimore, MD 21224, (410) 550-1547.
(Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug
Abuse and Addiction Research Programs, National Institutes of
Health, HHS)
Dated: January 14, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-1250 Filed 1-20-11; 8:45 am]
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