Meeting of the National Advisory Council for Healthcare Research and Quality, 39119-39120 [06-6164]
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Federal Register / Vol. 71, No. 132 / Tuesday, July 11, 2006 / Notices
Survey of Consumer Finance (SCF) will
be the latest in a triennial series, which
began in 1983, that provides
comprehensive data for U.S. families on
the distribution of assets and debts,
along with related information and
other data items necessary for analyzing
financial behavior. These are the only
surveys conducted in the United States
that provide such financial data for a
representative sample of households.
Data for the SCF are collected by
interviewers using a computer program.
While some questions may be deleted
and others modified, only minimal
changes will be made to the
questionnaire in order to preserve the
time series properties of the data. The
pretest would be conducted during 2006
and the survey would be conducted
between May 2007 and January 2008.
Board of Governors of the Federal Reserve
System, July 5, 2006.
Jennifer J. Johnson,
Secretary of the Board.
[FR Doc. E6–10782 Filed 7–10–06; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL RESERVE SYSTEM
Government in the Sunshine Act;
Meeting Notice
Board of
Governors of the Federal Reserve
System.
TIME AND DATE: 11:30 a.m., Monday, July
17, 2006.
PLACE: Marriner S. Eccles Federal
Reserve Board Building, 20th and C
Streets, NW., Washington, DC 20551
STATUS: Closed.
MATTERS TO BE CONSIDERED: 1. Personnel
actions (appointments, promotions,
assignments, reassignments, and salary
actions) involving individual Federal
Reserve System employees.
2. Any items carried forward from a
previously announced meeting.
FOR MORE INFORMATION PLEASE CONTACT:
Michelle Smith, Director, or Dave
Skidmore, Assistant to the Board, Office
of Board Members at 202–452–2955.
SUPPLEMENTARY INFORMATION: You may
call 202–452–3206 beginning at
approximately 5 p.m. two business days
before the meeting for a recorded
announcement of bank and bank
holding company applications
scheduled for the meeting; or you may
contact the Board’s Web site at https://
www.federalreserve.gov for an electronic
announcement that not only lists
applications, but also indicates
procedural and other information about
the meeting.
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AGENCY HOLDING THE MEETING:
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Dated: July 7, 2006.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. 06–6177 Filed 7–7–06; 3:57 pm]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the National Coordinator;
American Health Information
Community Biosurveillance Data
Steering Group Meeting
ACTION:
Announcement of meeting.
SUMMARY: This notice announces the
first meeting of the American Health
Information Community Biosurveillance
Data Steering Group in accordance with
the Federal Advisory Committee Act
(Pub. L. No. 92–463, 5 U.S.C., App.).
DATES: July 7, 2006 from 10 a..m. to 2
p.m.
ADDRESSES: Mary C. Switzer Building
(330 C Street, SW., Washington, DC
20201), Conference Room 4090.
FOR FURTHER INFORMATION CONTACT:
https://www.hhs.gov/healthit/ahic.html.
SUPPLEMENTARY INFORMATION: The
Biosurveillance Data Steering Group
must convene in early July 2006 in
advance of the final deliverable from the
Health Information Technology
Standards Panel related to the
Biosurveillance Use Case.
The meeting will be available via
internet access. Go to https://
www.hs.gov/healthit/ahic.html for
additional information on the meeting.
Judith Sparrow,
Director, American Health Information
Community, Office of Programs and
Coordination, Office of the National
Coordinator.
[FR Doc. 06–6113 Filed 7–10–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Meeting of the National Advisory
Council for Healthcare Research and
Quality
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of public meeting.
AGENCY:
SUMMARY: In accordance with section
10(a) of the Federal Advisory Committee
Act, this notice announces a meeting of
the National Advisory Council for
Healthcare Research and Quality.
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The meeting will held on Friday,
July 21, 2006, from 8:30 a.m. to 4 p.m.
and is open to the public.
ADDRESSES: The meeting will held in
The Eisenberg Conference Center, the
Agency for Healthcare Research and
Quality, 540 Gaither Road, Rockville,
Maryland 20850. The public is
reminded to bring a photo ID to enter a
Federal building.
FOR FURTHER INFORMATION CONTACT:
Deborah Queenan, Coordinator of the
Advisory Council, at the Agency for
Healthcare Research and Quality, 540
Gaither Road, Rockville, Maryland
20850, (301) 427–1330. For press-related
information, please contract Karen
Migdail at (301) 427–1855.
If sign language interpretation or other
reasonable accommodation for a
disability is needed, please contact Mr.
Donald L. Inniss, Director, Office of
Equal Employment Opportunity
Program, Program Support Center, on
(301) 443–1144 no later than July 14,
2006. Agenda, roster, and minutes from
previous council meetings are available
from Ms. Bonnie Campbell, Committee
Management Officer, Agency for
Healthcare Quality and Research, 540
Gaither Road, Rockville, Maryland
20850. Ms. Campbell’s phone number is
(301) 427–1554.
SUPPLEMENTARY INFORMATION:
DATES:
I. Purpose
Section 931 of the Public Health
Service Act (42 U.S.C. 299c) established
the National Advisory Council for
Healthcare Research and Quality. In
accordance with its statutory mandate,
the Council is to advise the Secretary of
the Department of Health and Human
Services and the Director, Agency for
Healthcare Research and Quality
(AHRQ), on matters related to actions of
the Agency to enhance the quality,
improve the outcomes, reduce the costs
of health care services, improve access
to such services through scientific
research, and to promote improvements
in clinical practice and in the
organization, financing and delivery of
health care services.
The Council is composed of members
of the public appointed by the
Secretary, and Federal ex-officio
members.
II. Agenda
On Friday, July 21, 2006, the meeting
will convene at 8:30 a.m. with the call
to order by the Council Chair. The
agenda will include the Director’s
update on the status of the Agency’s
current research, programs, and
initiatives; a presentation and
discussion on AHRQ’s research on
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Federal Register / Vol. 71, No. 132 / Tuesday, July 11, 2006 / Notices
health care efficiency; and an overview
of the National Healthcare Quality and
Disparities Reports. The final agenda
will be available on AHRQ’s Web site at
https://www.ahrq.gov no later than July
14, 2006.
The meeting will adjourn at 4 p.m.
Dated: July 5, 2006.
Carolyn M. Clancy,
Director.
[FR Doc. 06–6164 Filed 7–7–06; 2:05 pm]
Dated: July 3, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E6–10774 Filed 7–10–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
BILLING CODE 4160–90–M
[Docket No. 2005E–0236]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination of Regulatory Review
Period for Purposes of Patent
Extension; MULTIHANCE
Centers for Disease Control and
Prevention
AGENCY:
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Disease, Disability, and Injury
Prevention and ControlSpecial
Emphasis Panel: Targeted Evaluation
of the President’s Emergency Plan for
AIDS Relief (PEPFAR) Funded
Prevention of Mother-to-Child HIV
Transmission (PMTCT), and Adherence
to Antiretroviral Therapy (ART)
Programs, Contract Solicitation
Numbers (CSN) 2006–N–08428, 2006–
N–08429, and 2006–N–08430
Correction: This notice was published
in the Federal Register on June 9, 2006,
Volume 71, Number 111, page 33456.
The location of the meeting was
changed due to insufficient meeting
space at the Renaissance Concourse
Hotel—Marriott, One Hartsfield Center
Parkway, Atlanta, GA 30354. The
meeting was held at the Hilton Atlanta
Airport, 1031 Virginia Avenue, Atlanta,
Georgia 30354.
Titles: Targeted Evaluation of the
President’s Emergency Plan for AIDS
Relief (PEPFAR) Funded Prevention of
Mother-to-Child HIV Transmission
(PMTCT), and Adherence to
Antiretroviral Therapy (ART) Programs,
Contract Solicitation Numbers (CSN)
2006–N–08428, 2006–N–08429, and
2006–N–08430.
For Further Information Contact: Amy
L. Sandul, Health Scientist, National
Center for HIV, STD, and Tuberculosis
Prevention, Centers for Disease Control
and Prevention, 1600 Clifton Road, NE.,
MS E–41, Atlanta, GA 30333, Telephone
404–639–6485.
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.
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16:49 Jul 10, 2006
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Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
MULTIHANCE and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent that claims that
human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
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the exemption to permit the clinical
investigations of the human drug
product becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human drug product and continues
until FDA grants permission to market
the product. Although only a portion of
a regulatory review period may count
toward the actual amount of extension
that the Director of Patents and
Trademarks may award (for example,
half the testing phase must be
subtracted, as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA recently approved for marketing
the human drug product MULTIHANCE
(gadobenate dimeglumine).
MULTIHANCE is indicated for
intravenous use in magnetic resonance
imaging (MRI) of the central nervous
system in adults to visualize lesions
with abnormal blood brain barrier or
abnormal vascularity of the brain, spine,
and associated tissues. Subsequent to
this approval, the Patent and Trademark
Office received a patent term restoration
application for MULTIHANCE (U.S.
Patent No. 4,916,246) from Bracco
International B.V., and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated July 8, 2005, FDA advised
the Patent and Trademark Office that
this human drug product had undergone
a regulatory review period and that the
approval of MULTIHANCE represented
the first permitted commercial
marketing or use of the product.
Thereafter, the Patent and Trademark
Office requested that FDA determine the
product’s regulatory review period.
FDA has determined that the
applicable regulatory review period for
MULTIHANCE is 3,789 days. Of this
time, 2,482 days occurred during the
testing phase of the regulatory review
period, while 1,307 days occurred
during the approval phase. These
periods of time were derived from the
following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355) became effective: July 12, 1994.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on July 12, 1994.
2. The date the application was
initially submitted with respect to the
human drug product under section
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[Federal Register Volume 71, Number 132 (Tuesday, July 11, 2006)]
[Notices]
[Pages 39119-39120]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-6164]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Meeting of the National Advisory Council for Healthcare Research
and Quality
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Notice of public meeting.
-----------------------------------------------------------------------
SUMMARY: In accordance with section 10(a) of the Federal Advisory
Committee Act, this notice announces a meeting of the National Advisory
Council for Healthcare Research and Quality.
DATES: The meeting will held on Friday, July 21, 2006, from 8:30 a.m.
to 4 p.m. and is open to the public.
ADDRESSES: The meeting will held in The Eisenberg Conference Center,
the Agency for Healthcare Research and Quality, 540 Gaither Road,
Rockville, Maryland 20850. The public is reminded to bring a photo ID
to enter a Federal building.
FOR FURTHER INFORMATION CONTACT: Deborah Queenan, Coordinator of the
Advisory Council, at the Agency for Healthcare Research and Quality,
540 Gaither Road, Rockville, Maryland 20850, (301) 427-1330. For press-
related information, please contract Karen Migdail at (301) 427-1855.
If sign language interpretation or other reasonable accommodation
for a disability is needed, please contact Mr. Donald L. Inniss,
Director, Office of Equal Employment Opportunity Program, Program
Support Center, on (301) 443-1144 no later than July 14, 2006. Agenda,
roster, and minutes from previous council meetings are available from
Ms. Bonnie Campbell, Committee Management Officer, Agency for
Healthcare Quality and Research, 540 Gaither Road, Rockville, Maryland
20850. Ms. Campbell's phone number is (301) 427-1554.
SUPPLEMENTARY INFORMATION:
I. Purpose
Section 931 of the Public Health Service Act (42 U.S.C. 299c)
established the National Advisory Council for Healthcare Research and
Quality. In accordance with its statutory mandate, the Council is to
advise the Secretary of the Department of Health and Human Services and
the Director, Agency for Healthcare Research and Quality (AHRQ), on
matters related to actions of the Agency to enhance the quality,
improve the outcomes, reduce the costs of health care services, improve
access to such services through scientific research, and to promote
improvements in clinical practice and in the organization, financing
and delivery of health care services.
The Council is composed of members of the public appointed by the
Secretary, and Federal ex-officio members.
II. Agenda
On Friday, July 21, 2006, the meeting will convene at 8:30 a.m.
with the call to order by the Council Chair. The agenda will include
the Director's update on the status of the Agency's current research,
programs, and initiatives; a presentation and discussion on AHRQ's
research on
[[Page 39120]]
health care efficiency; and an overview of the National Healthcare
Quality and Disparities Reports. The final agenda will be available on
AHRQ's Web site at https://www.ahrq.gov no later than July 14, 2006.
The meeting will adjourn at 4 p.m.
Dated: July 5, 2006.
Carolyn M. Clancy,
Director.
[FR Doc. 06-6164 Filed 7-7-06; 2:05 pm]
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