Federal Register / Vol. 72, No. 132 / Wednesday, July 11, 2007 / Notices 37783 

This designation will become 

effective on July 22, 2007, unless 

Congress provides otherwise prior to the 

effective date. After this effective date, 

HHS will publish a notice in the 

Federal Register reporting the addition 

of this class to the SEC or the result of 

any provision by Congress regarding the 

decision by HHS to add the class to the 

SEC. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health (NIOSH), 4676 

Columbia Parkway, MS C–46, 

Cincinnati, OH 45226, Telephone 513–

533–6800 (this is not a toll-free 

number). Information requests can also 

be submitted by e-mail to 

OCAS@CDC.GOV. 

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: 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unpublished scientific evidence, as well 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 

http:// 

www.EffectiveHealthCare.ahrq.gov. 

SUPPLEMENTARY INFORMATION: Nominees 

not selected for the Stakeholder Group 


jlentini on PROD1PC65 with NOTICES
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 http:// 

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 

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 

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. 

SUPPLEMENTARY INFORMATION: 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 

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. 


jlentini on PROD1PC65 with NOTICES