Request for Nominations for AHRQ Study Section Members, 55333-55334 [2010-22544]
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Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: December 15, 2004.
The applicant claims December 14,
2004, as the date the new drug
application (NDA) for Uloric (NDA 21–
856) was initially submitted. However,
FDA records indicate that NDA 21–856
was submitted on December 15, 2004.
3. The date the application was
approved: February 13, 2009. FDA has
verified the applicant’s claim that NDA
21–856 was approved on February 13,
2009.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 5 years of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by November 9,
2010. Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by March 9, 2011. To meet its
burden, the petition must contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on
regulations.gov may be viewed in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: August 13, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–22521 Filed 9–9–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
National Center for Health Statistics,
(BSC, NCHS)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC), National
Center for Health Statistics (NCHS)
announces the following meeting of the
aforementioned committee.
Times and Dates:
11 a.m.–5:30 p.m., September 23,
2010.
8:30 a.m.–2 p.m., September 24, 2010.
Place: NCHS Headquarters, 3311
Toledo Road, Hyattsville, Maryland
20782.
Status: This meeting is open to the
public on a first come, first serve basis
up to the meeting room’s capacity.
However, visitors must be processed in
accordance with established Federal
policies and procedures. For foreign
nationals or non-US citizens, preapproval is required (please contact
Althelia Harris, 301–458–4261,
adw1@cdc.gov or Virginia Cain,
vcain@cdc.gov at least 10 days in
advance for requirements). All visitors
are required to present a valid form of
picture identification issued by a state,
Federal or international government. As
required by the Federal Property
Management Regulations, Title 41, Code
of Federal Regulation, Subpart 101–
20.301, all persons entering in or on
Federal controlled property and their
packages, briefcases, and other
containers in their immediate
possession are subject to being x-rayed
and inspected. Federal law prohibits the
knowing possession or the causing to be
present of firearms, explosives and other
dangerous weapons and illegal
substances. The meeting room
accommodates approximately 100
people.
Purpose: This committee is charged
with providing advice and making
recommendations to the Secretary,
Department of Health and Human
Services; the Director, CDC; and the
Director, NCHS, regarding the scientific
and technical program goals and
objectives, strategies, and priorities of
NCHS.
Matters to be discussed: The agenda
will include welcome remarks by the
Director, NCHS; update on the longterm care research program; a
discussion of the NCHS visitation
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55333
program and an open session for
comments from the public.
Requests to make oral presentations
should be submitted in writing to the
contact person listed below. All requests
must contain the name, address,
telephone number, and organizational
affiliation of the presenter.
Written comments should not exceed
five single-spaced typed pages in length
and must be received by September 17,
2010.
The agenda items are subject to
change as priorities dictate.
Contact person for more information:
Virginia S. Cain, PhD, Director of
Extramural Research, NCHS/CDC, 3311
Toledo Road, Room 7211, Hyattsville,
Maryland 20782, telephone (301) 458–
4500, fax (301) 458–4020.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both CDC and
the Agency for Toxic Substances and
Disease Registry.
Dated: September 3, 2010.
Elaine L. Baker,
Management Analysis and Services Office,
Centers for Disease Control and Prevention.
[FR Doc. 2010–22594 Filed 9–9–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Request for Nominations for AHRQ
Study Section Members
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for nominations for
public members.
AGENCY:
In accordance with Title IX of
the Public Health Service Act, see 42
U.S.C. 299c–1, and AHRQ’s grant and
contract regulations, 42 CFR part 67,
applications submitted to AHRQ will be
evaluated using the AHRQ peer review
process to ensure a fair, equitable, and
unbiased evaluation of their scientific
and technical merit. The initial peer
review of grant applications involves an
assessment conducted by panels of
experts established to include pertinent
scientific disciplines and medical
specialty areas. The confidential part of
the peer review meetings devoted to
critical evaluations will be closed
meetings in accordance with section
10(d) of the Federal Advisory
SUMMARY:
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Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices
Committee Act, as amended (5 U.S.C.
Appendix 2).
AHRQ is seeking nominations to fill
approximately 20 to 30 percent of its
study section membership, across the
following study sections:
(1) Health System Research (HSR),
(2) Health Care Technology and
Decision Sciences (HCTDS),
(3) Health Care Quality and
Effectiveness Research (HCQER), and
(4) Health Care Research Training
(HCRT).
The primary research foci and
functions of these four study sections
are described on the AHRQ Web site:
(http:Ilwww.AHRQ
.qovlfundlpeerrevlpeerdesc. htm).
Individuals from the health services
research and health care community
who could serve as peer reviewers on
these study sections are sought to
replace study section members whose
terms have expired. In sending your
nomination, please specify the
nominee’s professional/scientific/
technical expertise, affiliations and full
contact information, if this information
is available.
Factors that will be considered in the
selection of individuals to serve on
study sections include: competence in a
scientific, technical or clinical
discipline or research specialty,
particularly in health services research;
fairness and evenhandedness in
judgment and review; ability to work
effectively in a group context; and
commitment to complete work
assignments.
A diversity of perspectives is valuable
to AHRQ’s work. To help obtain a
diversity of perspectives among
nominees, AHRQ encourages
nominations of women and members of
minority populations. AHRQ also seeks
broad geographic representation.
DATES: AHRQ would like to receive your
recommendations no later than Friday,
October 1,2010.
ADDRESSES: Please direct your
correspondence to: Kishena C.
Wadhwani, PhD., M.P.H., Director,
Division of Scientific Review (DSR),
Office of Extramural Research,
Education and Priority Populations
(OEREP), Agency for Healthcare
Research and Quality (AHRQ),
Department of Health and Human
Services (DHHS), 540 Gaither Road,
Room 2032, Rockville, MD 20850,
Phone: (301) 427–1556, Fax: (301) 427–
1562, e-mail: Kishena.WadhwanjAHRQ
hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Kishena C. Wadhwani, PhD., M.P.H.
(See ADDRESSES section.)
SUPPLEMENTARY INFORMATION:
Background
Currently, AHRQ has one chartered
Health Services Research Initial Review
Group (IRG) responsible for the peer
review of research and training grant
applications submiffed for funding
consideration. The IRG is to advise the
Director of the Agency on matters
related to scientific and technical merit
of research grant proposals to improve
the quality, safety, efficiency, and
effectiveness of health care for all
Americans.
This IRG is currently comprised of
four subcommittees or study sections,
each with a particular research focus
around which peer reviewers’ expertise
is assembled. These study sections
convene three times per year to review
the grant applications submitted to the
three different submission cycles. Study
section members are appointed for up to
a maximum of four years.
Dated: September 1, 2010.
Carolyn M. Clancy,
Director, AHRQ.
[FR Doc. 2010–22544 Filed 9–9–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0444]
Schmid Laboratories, Inc. et al.;
Withdrawal of Approval of Five New
Drug Applications
AGENCY:
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of five new drug applications
(NDAs) from multiple holders of these
applications. The basis for the
withdrawals is that the holders of the
applications have repeatedly failed to
file required annual reports for the
applications.
SUMMARY:
DATES:
Effective September 10, 2010.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
The
holders of approved applications to
market new drugs for human use are
required to submit annual reports to
FDA concerning each of their approved
applications in accordance with
§ 314.81 (21 CFR 314.81).
In the Federal Register of September
24, 2009 (74 FR 49760), FDA published
a notice offering an opportunity for a
hearing (NOOH) on a proposal to
withdraw approval of five NDAs
because the firms had failed to submit
the required annual reports for these
applications. The holders of these
applications did not respond to the
NOOH. Failure to file a written notice
of participation and request for hearing
as required by § 314.200 (21 CFR
314.200) constitutes an election by the
applicant not to make use of the
opportunity for a hearing concerning the
proposal to withdraw approval of the
applications and a waiver of any
contentions concerning the legal status
of the drug products. Therefore, the
Director, Center for Drug Evaluation and
Research, is withdrawing approval of
the five applications listed in table 1 of
this document.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration,
HHS.
TABLE 1.
srobinson on DSKHWCL6B1PROD with NOTICES
Application
No.
Drug
Applicant
NDA 5–766
Ramses Vaginal Jelly
Schmid Laboratories, Inc., Route 46 West, Little Falls, NJ 07424
NDA 7–220
Synthetic Vitamin A (vitamin A palmitate)
Merck & Co., Inc., 770 Sumneytown Pike, P.O. Box 4, West Point, PA 19486
NDA 8–595
Immolin Vaginal Cream Jel
Schmid Laboratories, Inc.
NDA 8–612
Silicote (simethicone) Ointment
Arnar-Stone Laboratories, Inc., 601 East Kensington Rd., Mount Prospect, IL 60056
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[Federal Register Volume 75, Number 175 (Friday, September 10, 2010)]
[Notices]
[Pages 55333-55334]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22544]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Request for Nominations for AHRQ Study Section Members
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for nominations for public members.
-----------------------------------------------------------------------
SUMMARY: In accordance with Title IX of the Public Health Service Act,
see 42 U.S.C. 299c-1, and AHRQ's grant and contract regulations, 42 CFR
part 67, applications submitted to AHRQ will be evaluated using the
AHRQ peer review process to ensure a fair, equitable, and unbiased
evaluation of their scientific and technical merit. The initial peer
review of grant applications involves an assessment conducted by panels
of experts established to include pertinent scientific disciplines and
medical specialty areas. The confidential part of the peer review
meetings devoted to critical evaluations will be closed meetings in
accordance with section 10(d) of the Federal Advisory
[[Page 55334]]
Committee Act, as amended (5 U.S.C. Appendix 2).
AHRQ is seeking nominations to fill approximately 20 to 30 percent
of its study section membership, across the following study sections:
(1) Health System Research (HSR),
(2) Health Care Technology and Decision Sciences (HCTDS),
(3) Health Care Quality and Effectiveness Research (HCQER), and
(4) Health Care Research Training (HCRT).
The primary research foci and functions of these four study
sections are described on the AHRQ Web site: (http:Ilwww.AHRQ
.qovlfundlpeerrevlpeerdesc. htm).
Individuals from the health services research and health care
community who could serve as peer reviewers on these study sections are
sought to replace study section members whose terms have expired. In
sending your nomination, please specify the nominee's professional/
scientific/technical expertise, affiliations and full contact
information, if this information is available.
Factors that will be considered in the selection of individuals to
serve on study sections include: competence in a scientific, technical
or clinical discipline or research specialty, particularly in health
services research; fairness and evenhandedness in judgment and review;
ability to work effectively in a group context; and commitment to
complete work assignments.
A diversity of perspectives is valuable to AHRQ's work. To help
obtain a diversity of perspectives among nominees, AHRQ encourages
nominations of women and members of minority populations. AHRQ also
seeks broad geographic representation.
DATES: AHRQ would like to receive your recommendations no later than
Friday, October 1,2010.
ADDRESSES: Please direct your correspondence to: Kishena C. Wadhwani,
PhD., M.P.H., Director, Division of Scientific Review (DSR), Office of
Extramural Research, Education and Priority Populations (OEREP), Agency
for Healthcare Research and Quality (AHRQ), Department of Health and
Human Services (DHHS), 540 Gaither Road, Room 2032, Rockville, MD
20850, Phone: (301) 427-1556, Fax: (301) 427-1562, e-mail:
Kishena.WadhwanjAHRQ hhs.gov.
FOR FURTHER INFORMATION CONTACT: Kishena C. Wadhwani, PhD., M.P.H. (See
ADDRESSES section.)
SUPPLEMENTARY INFORMATION:
Background
Currently, AHRQ has one chartered Health Services Research Initial
Review Group (IRG) responsible for the peer review of research and
training grant applications submiffed for funding consideration. The
IRG is to advise the Director of the Agency on matters related to
scientific and technical merit of research grant proposals to improve
the quality, safety, efficiency, and effectiveness of health care for
all Americans.
This IRG is currently comprised of four subcommittees or study
sections, each with a particular research focus around which peer
reviewers' expertise is assembled. These study sections convene three
times per year to review the grant applications submitted to the three
different submission cycles. Study section members are appointed for up
to a maximum of four years.
Dated: September 1, 2010.
Carolyn M. Clancy,
Director, AHRQ.
[FR Doc. 2010-22544 Filed 9-9-10; 8:45 am]
BILLING CODE 416Q-90-M
