National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 70462-70463 [2011-29311]
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70462
Federal Register / Vol. 76, No. 219 / Monday, November 14, 2011 / Notices
collection and has assigned OMB
control number 0910–0167. The
approval expires on October 31, 2014. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: November 7, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2011–29296 Filed 11–10–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Advisory Committee for Reproductive
Health Drugs; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Advisory
Committee for Reproductive Health
Drugs.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on January 20, 2012, from 8 a.m.
to 4:30 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You’’, click
on ‘‘Public Meetings at the FDA White
Oak Campus’’. Please note that visitors
to the White Oak Campus must enter
through Bldg. 1.
Contact Person:
Kalyani Bhatt, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, (301)
796–9001, FAX: (301) 847–8533, email:
ACRHD@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–(800)
741–8138, (301) 443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
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area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you 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
the benefits and risks of new drug
application 22–139, progesterone gel
8%, Columbia Laboratories, Inc., for the
proposed indication of ‘‘reduction of
risk of preterm birth in women with
short uterine cervical length regardless
of other risk factors in the mid-trimester
of pregnancy.’’ The uterine cervix is the
mouth of the uterus (or womb) leading
into the vagina (or birth canal). The
benefit/risk discussion will focus on the
adequacy of the demonstration of
efficacy in the U.S. population.
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 January 10, 2012.
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 January
3, 2012. 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
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notify interested persons regarding their
request to speak by January 4, 2012.
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 Kalyani
Bhatt at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
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: November 7, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–29181 Filed 11–10–11; 8:45 am]
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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: Heart, Lung, and
Blood Initial Review Group; Heart, Lung, and
Blood Program Project Review Committee.
Date: December 2, 2011.
Time: 8 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: Double Tree Bethesda Hotel, 8120
Wisconsin Avenue, Bethesda, MD 20814.
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Federal Register / Vol. 76, No. 219 / Monday, November 14, 2011 / Notices
Contact Person: Jeffrey H. Hurst, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7208, Bethesda, MD 20892–7924, (301) 435–
0303, hurstj@nhlbi.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: November 7, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Lyle Furr, Contract Review
Specialist, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, Room 4227, MSC 9550, 6001
Executive Boulevard, Bethesda, MD 20892–
9550, (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)
70463
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Carol Hamelink, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4192,
MSC 7850, Bethesda, MD 20892, (301) 213–
9887 hamelinc@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
[FR Doc. 2011–29311 Filed 11–10–11; 8:45 am]
Dated: November 7, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
[FR Doc. 2011–29310 Filed 11–10–11; 8:45 am]
Dated: November 7, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
[FR Doc. 2011–29307 Filed 11–10–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meetings
mstockstill on DSK4VPTVN1PROD with NOTICES
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 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;
Preclinical Medications Discovery and Abuse
Liability Testing (8904).
Date: December 6, 2011.
Time: 9:30 a.m. to 12 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Lyle Furr, Contract Review
Specialist, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, Room 4227, MSC 9550, 6001
Executive Boulevard, Bethesda, MD 20892–
9550, (301) 435–1439, lf33c.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; Purity
Specifications, Storage and Distribution for
Medications Development (8903).
Date: January 4, 2012.
Time: 9:30 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
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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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; NANO
Special Panel.
Date: December 5, 2011.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: James J. Li, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5148,
MSC 7849, Bethesda, MD 20892, (301) 806–
8065, lijames@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Aging and Neurodegenerative
Disorders.
Date: December 9, 2011.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
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DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
Exercise of Authority Under the
Immigration and Nationality Act
Office of the Secretary, DHS.
Notice of determination.
AGENCY:
ACTION:
Authority: 8 U.S.C. 1182(d)(3)(B)(i).
Following consultations with the
Secretary of State and the Attorney
General, I hereby conclude, as a matter
of discretion in accordance with the
authority granted to me by section
212(d)(3)(B)(i) of the Immigration and
Nationality Act (INA), 8 U.S.C.
1182(d)(3)(B)(i), as amended, as well as
the foreign policy and national security
interests deemed relevant in these
consultations, that subsections
212(a)(3)(B)(iv)(VI)(bb), (cc), and (dd) of
the INA, 8 U.S.C.
1182(a)(3)(B)(iv)(VI)(bb), (cc), and (dd),
shall not apply with respect to the
provision of medical care by an alien,
provided that the alien satisfies the
relevant agency authority that the alien:
(a) Is seeking a benefit or protection
under the INA and has been determined
to be otherwise eligible for the benefit
or protection;
(b) Has undergone and passed all
relevant background and security
checks;
(c) Has fully disclosed, to the best of
his or her knowledge, in all relevant
applications and interviews with U.S.
government representatives and agents,
the nature and circumstances of any
medical care provided and any other
activity or association falling within the
scope of section 212(a)(3)(B) of the INA,
8 U.S.C. 1182(a)(3)(B);
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Agencies
[Federal Register Volume 76, Number 219 (Monday, November 14, 2011)]
[Notices]
[Pages 70462-70463]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29311]
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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: Heart, Lung, and Blood Initial Review Group;
Heart, Lung, and Blood Program Project Review Committee.
Date: December 2, 2011.
Time: 8 a.m. to 2 p.m.
Agenda: To review and evaluate grant applications.
Place: Double Tree Bethesda Hotel, 8120 Wisconsin Avenue,
Bethesda, MD 20814.
[[Page 70463]]
Contact Person: Jeffrey H. Hurst, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room 7208, Bethesda, MD
20892-7924, (301) 435-0303, hurstj@nhlbi.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: November 7, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-29311 Filed 11-10-11; 8:45 am]
BILLING CODE 4140-01-P