Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 1013: Request for Nominations-The Effective Health Care Stakeholder Group, 37783-37784 [07-3360]
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Federal Register / Vol. 72, No. 132 / Wednesday, July 11, 2007 / Notices
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Larry Elliott, Director, Office of
Compensation Analysis and Support,
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Dated: July 6, 2007.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 07–3363 Filed 7–10–07; 8:45 am]
BILLING CODE 4160–17–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Medicare Prescription Drug,
Improvement, and Modernization Act
of 2003 Section 1013: Request for
Nominations—The Effective Health
Care Stakeholder Group
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of invitation to submit
nominations for the Effective Health
Care Stakeholder Group.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: The DHHS Agency for
Healthcare Research and Quality
(AHRQ) invites nominations from
interested organizations and
knowledgeable individuals for a
Stakeholder Group to support the work
of the Effective Health Care Program,
funded under Section 1013 of the
Medicare Prescription Drug,
Improvement and Modernization Act
(MMA) of 2003. The goals of this
program are to develop evidence on the
effectiveness and comparative
effectiveness of different treatments and
health care interventions of importance
to the Medicare, Medicaid, and State
Child Health Insurance. To achieve
these goals, AHRQ is supporting
projects to review, synthesize, generate
and translate published and
unpublished scientific evidence, as well
as identify important issues for which
VerDate Aug<31>2005
17:56 Jul 10, 2007
Jkt 211001
existing scientific evidence is
insufficient to inform decisions about
health care. This evidence will be made
readily available to all heath care
decision-makers. The Stakeholder
Group is critical to the success of this
project, providing input to the program
in collaboration with the Effective
Health Care Scientific Resource Center
(currently based at the Oregon
Evidence-based Practice Center).
The role of the Stakeholder Group
will be to:
• Provide input on critical research
information gaps for practice and policy
and on identifying and developing the
key research questions to address these
gaps.
• Provide input on implementation
issues for Effective Heath Care program
reports and findings.
• Define information needs and
identify types of projects that will be
most useful.
• Provide feedback from report users.
• Provide guidance on the program as
a whole for quality improvement.
• Provide guidance on how the
program can have more of an impact
with users.
Members will serve as volunteers for
a two-year period from October 2007
through September 2009. Stakeholder
Group members will attend 3–4
meetings per year as part of this process.
Meetings will be held in Rockville, MD
and Portland, Oregon. Meetings will be
1-2 days in length. The Scientific
Resource Center (SRC) will make the
travel arrangements. The first meeting
will be held on October 26, 2007, in
Rockville, MD.
Members are expected to actively
participate in meetings and to engage in
related activities by phone and e-mail
between meetings. Between-meeting
work may include assisting with agenda
planning and session preparation for
Stakeholder meetings, consulting with
SRC or AHRQ staff on constituency
issues, and serving as a resource to the
Effective Health Care Program. It is
anticipated that the Stakeholder Group
member time commitment between
meetings will not exceed 10 hours.
The Stakeholder Group will be
composed of up to 15 members. The
group will represent several broad
constituencies of stakeholders and
decision-makers at the policy, system,
and clinical levels, which will include:
• Third party healthcare payers
(including, but not limited to public
State or Federal Medicare or Medicaid
programs, and private insurance health
plans and Health maintenance
Organizations).
• Employers and health-related
business groups.
PO 00000
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Fmt 4703
Sfmt 4703
37783
• Pharmacy and therapeutic
committees.
• Healthcare providers.
• Patient/consumer organizations.
• Consumers of Federal and State
beneficiary programs.
• Healthcare industry professional
organizations.
• Academic researchers (including,
but not limited to those with expertise
in evidence-based methods and
effectiveness and translational research).
Self-nominations are encouraged.
Materials to be submitted are a cover
letter and curriculum vitae or similar
supportive documentation. The cover
letter will provide information on how
the nominee’s experience, skills and
roles fit with the composition and goals
of the Stakeholder Group as described
above. Specific information on nominee
experience in the constituency groups
described above is required. Nominees
chosen for the Stakeholder Group will
be required to declare and submit
conflict of interest documentation. This
will not necessarily preclude service.
Nominees may indicate their
willingness to be considered in
subsequent calls for nominations if not
selected for this Stakeholder Group in
their supporting documentation.
All nominations received by
submission deadline will be reviewed
by a committee composed of
representatives from AHRQ and the
SRC. Nominees who best represent the
broad constituencies described as the
goal for composition of the Stakeholder
Group will be selected and notified by
September 28, 2007. In addition, AHRQ
is interested in fostering diversity and
including representatives of, or
individuals with expertise regarding,
populations experiencing health care
disparities and in this case individuals
with expertise regarding chronic
conditions and health care needs of the
Medicare, Medicaid, and State
Children’s Health Insurance Program
(SCHIP) populations.
DATES: Nominations for the Effective
Health Care Stakeholder Group must be
received by August 31, 2007.
ADDRESSES: Nominations for
consideration may be e-mailed to
EffectiveHealthCare@ahrq.gov.
FOR FURTHER INFORMATION CONTACT:
Effective Health Care Program at (301)
427–1502 or
EffectiveHealthCare@ahrq.gov.
More information about the Effective
Health Care Program is available at
https://
www.EffectiveHealthCare.ahrq.gov.
Nominees
not selected for the Stakeholder Group
SUPPLEMENTARY INFORMATION:
E:\FR\FM\11JYN1.SGM
11JYN1
37784
Federal Register / Vol. 72, No. 132 / Wednesday, July 11, 2007 / Notices
are invited to participate in the Effective
Healthcare Program by making
suggestions for research and providing
comment on key questions and draft
reviews. In addition, a listserv has been
established and those interested may
join to be notified when items of interest
become available for review or public
comment. Opportunities for
involvement in the Effective Health Care
Program are described at https://
www.EffectiveHealthCare.ahrq.gov.
Dated: July 3, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07–3360 Filed 7–10–07; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: ANA Consultant and Evaluator
Qualifications Form.
OMB No.: 0970–0265.
Description: The ANA Consultant and
Evaluator Qualifications Form is used to
collect information from prospective
proposal reviewers in compliance with
42 U.S.C. 2291d–1. The form will allow
the Commissioner of ANA to select
qualified people to review grant
applications for Social and Economic
Development Strategies (SEDS), Native
Language Preservation and
Maintenance, Environmental Regulatory
Enhancement, and Environmental
Mitigation. The panel review process is
a legislative mandate in the ANA grant
funding process.
Respondents: Native Americans,
Native Alaskans, Native Hawaiians and
other Pacific Islanders.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average burden hours per
response
Total burden
hours
ANA Consultant and Evaluator Qualifications Form .......................................
300
1
1
300
jlentini on PROD1PC65 with NOTICES
Estimated Total Annual Burden
Hours: 300.
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: July 5, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07–3351 Filed 7–10–07; 8:45 am]
BILLING CODE 4184–01–M
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17:56 Jul 10, 2007
Jkt 211001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P–0218]
Determination That ARISTOCORT
FORTE Injectable Suspension
(Triamcinolone Diacetate), 40
Milligrams per Milliliter, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that ARISTOCORT FORTE Injectable
Suspension (triamcinolone diacetate),
40 milligrams (mg) per milliliter (mL),
was not withdrawn from sale for reasons
of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for triamcinolone
diacetate suspension, 40 mg/mL.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Sadove, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
SUPPLEMENTARY INFORMATION:
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Fmt 4703
Sfmt 4703
under an ANDA procedure. ANDA
sponsors must, with certain exceptions,
show that the drug for which they are
seeking approval contains the same
active ingredient in the same strength
and dosage form as the ‘‘listed drug,’’
which is typically a version of the drug
that was previously approved. Sponsors
of ANDAs do not have to repeat the
extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under 21 CFR 314.161(a)(1), the
agency must determine whether a listed
drug was withdrawn from sale for
reasons of safety or effectiveness before
an ANDA that refers to that listed drug
may be approved. FDA may not approve
an ANDA that does not refer to a listed
drug.
E:\FR\FM\11JYN1.SGM
11JYN1
]]>Agencies
[Federal Register Volume 72, Number 132 (Wednesday, July 11, 2007)]
[Notices]
[Pages 37783-37784]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-3360]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Medicare Prescription Drug, Improvement, and Modernization Act of
2003 Section 1013: Request for Nominations--The Effective Health Care
Stakeholder Group
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Notice of invitation to submit nominations for the Effective
Health Care Stakeholder Group.
-----------------------------------------------------------------------
SUMMARY: The DHHS Agency for Healthcare Research and Quality (AHRQ)
invites nominations from interested organizations and knowledgeable
individuals for a Stakeholder Group to support the work of the
Effective Health Care Program, funded under Section 1013 of the
Medicare Prescription Drug, Improvement and Modernization Act (MMA) of
2003. The goals of this program are to develop evidence on the
effectiveness and comparative effectiveness of different treatments and
health care interventions of importance to the Medicare, Medicaid, and
State Child Health Insurance. To achieve these goals, AHRQ is
supporting projects to review, synthesize, generate and translate
published and unpublished scientific evidence, as well as identify
important issues for which existing scientific evidence is insufficient
to inform decisions about health care. This evidence will be made
readily available to all heath care decision-makers. The Stakeholder
Group is critical to the success of this project, providing input to
the program in collaboration with the Effective Health Care Scientific
Resource Center (currently based at the Oregon Evidence-based Practice
Center).
The role of the Stakeholder Group will be to:
Provide input on critical research information gaps for
practice and policy and on identifying and developing the key research
questions to address these gaps.
Provide input on implementation issues for Effective Heath
Care program reports and findings.
Define information needs and identify types of projects
that will be most useful.
Provide feedback from report users.
Provide guidance on the program as a whole for quality
improvement.
Provide guidance on how the program can have more of an
impact with users.
Members will serve as volunteers for a two-year period from October
2007 through September 2009. Stakeholder Group members will attend 3-4
meetings per year as part of this process. Meetings will be held in
Rockville, MD and Portland, Oregon. Meetings will be 1-2 days in
length. The Scientific Resource Center (SRC) will make the travel
arrangements. The first meeting will be held on October 26, 2007, in
Rockville, MD.
Members are expected to actively participate in meetings and to
engage in related activities by phone and e-mail between meetings.
Between-meeting work may include assisting with agenda planning and
session preparation for Stakeholder meetings, consulting with SRC or
AHRQ staff on constituency issues, and serving as a resource to the
Effective Health Care Program. It is anticipated that the Stakeholder
Group member time commitment between meetings will not exceed 10 hours.
The Stakeholder Group will be composed of up to 15 members. The
group will represent several broad constituencies of stakeholders and
decision-makers at the policy, system, and clinical levels, which will
include:
Third party healthcare payers (including, but not limited
to public State or Federal Medicare or Medicaid programs, and private
insurance health plans and Health maintenance Organizations).
Employers and health-related business groups.
Pharmacy and therapeutic committees.
Healthcare providers.
Patient/consumer organizations.
Consumers of Federal and State beneficiary programs.
Healthcare industry professional organizations.
Academic researchers (including, but not limited to those
with expertise in evidence-based methods and effectiveness and
translational research).
Self-nominations are encouraged. Materials to be submitted are a
cover letter and curriculum vitae or similar supportive documentation.
The cover letter will provide information on how the nominee's
experience, skills and roles fit with the composition and goals of the
Stakeholder Group as described above. Specific information on nominee
experience in the constituency groups described above is required.
Nominees chosen for the Stakeholder Group will be required to declare
and submit conflict of interest documentation. This will not
necessarily preclude service. Nominees may indicate their willingness
to be considered in subsequent calls for nominations if not selected
for this Stakeholder Group in their supporting documentation.
All nominations received by submission deadline will be reviewed by
a committee composed of representatives from AHRQ and the SRC. Nominees
who best represent the broad constituencies described as the goal for
composition of the Stakeholder Group will be selected and notified by
September 28, 2007. In addition, AHRQ is interested in fostering
diversity and including representatives of, or individuals with
expertise regarding, populations experiencing health care disparities
and in this case individuals with expertise regarding chronic
conditions and health care needs of the Medicare, Medicaid, and State
Children's Health Insurance Program (SCHIP) populations.
DATES: Nominations for the Effective Health Care Stakeholder Group must
be received by August 31, 2007.
ADDRESSES: Nominations for consideration may be e-mailed to
EffectiveHealthCare@ahrq.gov.
FOR FURTHER INFORMATION CONTACT: Effective Health Care Program at (301)
427-1502 or EffectiveHealthCare@ahrq.gov.
More information about the Effective Health Care Program is
available at https://www.EffectiveHealthCare.ahrq.gov.
SUPPLEMENTARY INFORMATION: Nominees not selected for the Stakeholder
Group
[[Page 37784]]
are invited to participate in the Effective Healthcare Program by
making suggestions for research and providing comment on key questions
and draft reviews. In addition, a listserv has been established and
those interested may join to be notified when items of interest become
available for review or public comment. Opportunities for involvement
in the Effective Health Care Program are described at https://
www.EffectiveHealthCare.ahrq.gov.
Dated: July 3, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07-3360 Filed 7-10-07; 8:45 am]
BILLING CODE 4160-90-M
