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. 


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