50390 Federal Register / Vol. 62, No. 186 / Thursday, September 25, 1997 / Notices

Application No. Drug Applicant

ANDA 88–015 THEO–DUR (Theophylline Sustained-release Capsules)

Sprinkle, 75 mg

Do.

ANDA 88–016 THEO–DUR (Theophylline Sustained-release Capsules)

Sprinkle, 125 mg

Do.

ANDA 88–022 THEO–DUR (Theophylline Sustained-release Capsules)

Sprinkle, 50 mg

Do.

ANDA 88–066 Hydrocone Bitartrate and Homatropine Methylbromide Syrup,

5 mg/1.5 mg per5 mL

Halsey Drug Co., 1827 Pacific St., Brooklyn, NY 11233.

ANDA 88–112 Tripodrine (Triprolidine and Pseudoephedrine Hydrochlorides

Tablets USP) 2.5 mg/60 mg

Danbury Pharmacal, Inc., 131 West St., Danbury, CT 06810.

ANDA 88–140 Chlorthalidone Tablets USP, 50 mg Purepac Pharmaceutical.

ANDA 88–178 Hydralazine Hydrochloride Tablets, 50 mg Do.

ANDA 88–360 Fluocinolone Acetonide Cream USP, 0.025% Alpharma.

ANDA 88–361 Fluocinolone Acetonide Cream USP, 0.01% Do.

ANDA 88–950 Tolbutamide Tablets, 500 mg Purepac Pharmaceutical.

ANDA 88–997 Dexamethasone Elixir USP, 0.5 mg/5 mL Alpharma.

ANDA 89–754 Hydrocortisone Cream USP, 2.5% Do.

ANDA 89–840 Procainamide Hydrochloride Extended-release Tablets, 500

mg

Inwood Laboratories.

Therefore, under section 505(e) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 355(e)) and under authority

delegated to the Director, Center for

Drug Evaluation and Research (21 CFR

5.82), approval of the applications listed

in the table in this document, and all

amendments and supplements thereto,

is hereby withdrawn, effective

September 25, 1997.

Dated: September 11, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–25369 Filed 9–24–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Delegation of Authority

Notice is hereby given that I have

delegated to the Director, Centers for

Disease Control and Prevention, with

authority to redelegate, the following

authorities vested in the Secretary of

Health and Human Services under Title

XXVI of the Public Health Service Act,

‘‘Health Care Services Program,’’ and

the Ryan White Care Act Amendments

of 1996 (P.L. 104–146), as amended

hereafter, insofar as these authorities

pertain to the functions assigned to the

Centers for Disease Control and

Prevention:

Section 2625—CDC Guidelines for Pregnant

Women

Section 2626—Perinatal Transmission of HIV

Disease; Contingent Requirement

Regarding State Grants Under This Part

Section 2628—Report by the Institute of

Medicine

Sections 2641–2650—Formula Grants for

States

Sections 2661–2667—General Provisions

Section 2675—Coordinaiton

Section 2680—Grants to States and political

subdivisions of States to implement

guidelines and model curriculum for

health workers and public safety workers,

including emergency response employees.

Sections 2681–2690—Notificaiton of Possible

Exposure to Infectious Diseases

The Centers for Disease Control and

Prevention and the Health Resources

and Services Administration shall

cooperate in the implementation of

Section 2626(e).

This delegation shall be excised under

the Department’s existing delegation of

authority and policy on regulations.

This delegation became effective upon

date of signature. In addition, I have

affirmed and ratified any actions taken

by the Director, Centers for Disease

Control and Prevention or his

subordinates which involved the

exercise of the authorities delegated

herein prior to the effective date of the

delegation.

Dated: September 15, 1997.

Donna E. Shalala,

Secretary.

[FR Doc. 97–25467 Filed 9–24–97; 8:45 am]

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–97]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Reinstatement, without change,

of a previously approved collection for

which approval has expired; Title of

Information Collection: Requirement to

Disclose HMO Financial Information to

Members and Supporting Regulations in

42 CFR 417.124; Form No.: HCFA–R–

0097 (OMB 0938–0472); Use: Federally