Board of Scientific Counselors, National Center for Health Statistics, (BSC, NCHS), 55333 [2010-22594]
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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
PO 00000
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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]
BILLING CODE 4163–18–P
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:
E:\FR\FM\10SEN1.SGM
10SEN1
]]>Agencies
[Federal Register Volume 75, Number 175 (Friday, September 10, 2010)]
[Notices]
[Page 55333]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22594]
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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, pre-approval 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 long-term care research program; a
discussion of the NCHS visitation 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]
BILLING CODE 4163-18-P
