1338 Federal Register / Vol. 62, No. 6 / Thursday, January 9, 1997 / Notices

Application no. Drug Applicant

NDA 12–966 ............... Masterone (dromostanolone propionate) ............................ Hoffman-La Roche, Inc.

NDA 13–071 ............... Libritabs (chlordiazepoxide) Tablets, 5, 10, 25 milligrams

(mg).

Do.

NDA 13–664 ............... GANTANOL (sulfamethoxazole) Suspension ...................... Do.

NDA 16–109 ............... Sinubid (acetaminophen, phenylpropanolamine HCl, and

phenyltoloxamine citrate) Extended Release Tablets.

Parke-Davis, 2800 Plymouth Rd., Ann Arbor, MI 48105.

NDA 16–943 ............... Halotex (haloprogin) 1% Solution ........................................ Westwood-Squibb Pharmaceuticals, Inc.,100 Forest Ave.,

Buffalo, NY 14213–1091.

NDA 17–914 ............... OTIC–TRIDESILON (desonide-acetic acid) Solution 0.05% Bayer Corp., 400 Morgan Ln., West Haven, CT 06516–

4175.

NDA 18–366 ............... Chymex (bentiromide) Solution ........................................... Savage Laboratories, Division of Altana, Inc., 60 Baylis

Rd., Melville, NY 11747.

NDA 18–470 ............... Cibacalcin (calcitonin-human, for injection) ......................... Ciba-Geigy Corp., Summit, NJ 07901.

AADA 62–078 ............. Ampicillin Trihydrate (bulk) .................................................. Sandoz Pharmaceuticals, 59 Route 10, East Hanover,

NJ07936–1080.

ANDA 70–120 ............. Propranolol Hydrochloride Tablets, 10 mg .......................... Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ

07033.

ANDA 70–121 ............. Propranolol Hydrochloride Tablets, 20 mg .......................... Do.

ANDA 70–122 ............. Propranolol Hydrochloride Tablets, 40 mg .......................... Do.

ANDA 70–123 ............. Propranolol Hydrochloride Tablets, 60 mg .......................... Do.

ANDA 70–124 ............. Propranolol Hydrochloride Tablets, 80 mg .......................... Do.

ANDA 85–288 ............. Acetaminophen and Codeine Phosphate Tablets USP,

300 mg/30 mg.

KV Pharmaceutical Co., 2503 South Hanley Rd., St.

Louis, MO 63144–2555.

ANDA 85–484 ............. Chlorpromazine Hydrochloride Tablets, USP, 50 mg ......... Do.

ANDA 85–748 ............. Chlorpromazine Hydrochloride Tablets, USP, 200 mg ....... Do.

ANDA 85–750 ............. Chlorpromazine Hydrochloride Tablets, USP, 10 mg ......... Do.

ANDA 85–751 ............. Chlorpromazine Hydrochloride Tablets, USP, 25 mg ......... Do.

ANDA 85–752 ............. Chlorpromazine Hydrochloride Tablets, USP, 100 mg ....... Do.

ANDA 87–819 ............. Hydroxyzine Hydrochloride Tablets, USP, 10 mg ............... Do.

ANDA 87–820 ............. Hydroxyzine Hydrochloride Tablets, USP, 25 mg ............... Do.

ANDA 87–821 ............. Hydroxyzine Hydrochloride Tablets, USP, 50 mg ............... Do.

ANDA 87–822 ............. Hydroxyzine Hydrochloride Tablets, USP, 100 mg ............. Do.

ANDA 88–344 ............. Triprolidine Hydrochloride Pseudoephedrine Hydrochloride

Syrup, 1.25 mg/30 mg per 5 milliliters (mL).

H. R. Cenci Laboratories, Inc., P.O. Box 12524, Fresno,

CA 93778–2524.

ANDA 88–814 ............. Promethazine with Codeine Syrup (Promethazine Hydrochloride and Codeine Phosphate Oral Solution, 6.25

mg/10 mg/5 mL).

Do.

ANDA 88–815 ............. Promethazine VC Plain Syrup (Promethazine Hydrochloride and Phenylephrine Hydrochloride Oral Solution,

6.25 mg/5 mg/5 mL).

Do.

ANDA 88–816 ............. Promethazine Hydrochloride, Phenylephrine Hydrochloride, Codeine Phospate Syrup, 6.25 mg/5 mg/10 mg

per 5 mL.

Do.

ANDA 89–018 ............. Triprolidine Hydrochloride Pseudoephedrine Hydrochloride

and Codeine Phosphate Cough Syrup, 1.25 mg/30 mg/

10 mg per 5 mL.

Do.

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 February

10, 1997.

Dated: December 30, 1996.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–524 Filed 1–8–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

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, has submitted to the

Office of Management and Budget

(OMB) the following proposals for the

collection of information. 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.

1. Type of Request: Revision of a

currently approved collection; Title of

Information Collection: Statistical

Report on Medical Care: Eligibles,

Recipients, Payments and Services;

Form No.: HCFA–2082; Use: The data

reported in the HCFA–2082 are the basis

of actuarial forecasts for Medicaid

service utilization and costs; of analysis

and cost savings estimates required for

legislative initiatives relating to
Federal Register / Vol. 62, No. 6 / Thursday, January 9, 1997 / Notices 1339

Medicaid and for responding to requests

for information from HCFA

components, the Department, Congress

and other customers.; Frequency:

Annually; Affected Public: State, local,

or tribal government; Number of

Respondents: 54; Total Annual

Responses: 54; Total Annual Hours:

17,214.

To request copies of the proposed

paperwork collection referenced above,

E-mail your request, including your

address, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections should be sent

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Financial and Human

Resources, Management Analysis and

Planning Staff, Attention: Linda

Mansfield, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: December 31, 1996.

Edwin J . Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–455 Filed 1–8–97; 8:45 am]

BILLING CODE 4120–03–P

Health Resources and Services

Administration

Council on Graduate Medical

Education Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Public Law 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of February 1997:

Name: Council on Graduate Medical

Education

Date and Time: February 5, 1997, 1:00

p.m.—5:00 p.m., February 6, 1997, 8:30

a.m.—4:00 p.m.

Place: Omni Shoreham Hotel, 2500 Calvert

Street, N.W., Washington, D.C. 20008,

Palladian Room.

This meeting is open to the Public.

Agenda: The agenda will include two

panel discussions, one is a summary of the

current policy environment, the other

academic medicine, managed care and GME.

Discussions on the suggested future

directions for COGME. Reports and

recommendations in the following areas:

International Medical Graduates and Options

Paper—Reducing First-Year Resident

Numbers.

Anyone requiring information regarding

the subject should contact F. Lawrence Clare,

M.D., M.P.H., Deputy Executive Secretary,

telephone (301) 443–6326, Council on

Graduate Medical Education, Division of

Medicine, Bureau of Health Professions,

Room 9A–27, Parklawn Building, 5600

Fishers Lane, Rockville, Maryland 20857.

Agenda items are subject to change as

priorities dictate.

Dated: January 3, 1997.

J. Henry Montes,

Director, Office of Policy and Information

Coordination.

[FR Doc. 97–522 Filed 1–8–97; 8:45 am]

BILLING CODE 4160–15–P

National Institutes of Health

National Center for Research

Resources; Notice of Closed Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Center for Research Resources

Special Emphasis Panel (SEP) meeting:

Name of SEP: Biomedical Research

Technology (Telephone Conference Call).

Date: January 30, 1997.

Time: 2:00 p.m.

Place: National Institutes of Health, 6705

Rockledge Drive, MSC 7965, Room 6018,

Bethesda, MD 20892–7965.

Contact Person: Dr. Sharon Moss,

Scientific Review Administrator, 6705

Rockledge Drive, MSC 7965, Room 6018,

Bethesda, MD 20892–7965, (301) 435–0822.

Purpose/Agenda: To evaluate and review

contract proposals.

This notice is being published less than 15

days prior to the above meeting due to the

urgent need to meet timing limitations

imposed by the review and funding cycle.

The meeting will be closed in accordance

with the provisions set forth in secs.

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program No. 93.371, Biomedical Research

Technology, National Institutes of Health,

HHS)

Dated: January 3, 1997.

Paula N. Hayes,

Acting Committee Management Officer, NIH.

[FR Doc. 97–447 Filed 1–8–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Preparation of a Joint Environmental

Impact Statement /Environmental

Impact Report for Federal and State

Actions Associated With Furthering

the Purposes of the September 28,

1996, Agreement Between the United

States, State of California, and

MAXXAM, Inc. and its Subsidiary,

Pacific Lumber Company

AGENCY: Fish and Wildlife Service,

Interior.

Cooperating Agencies: National

Marine Fisheries Service, National

Oceanic and Atmospheric

Administration, Commerce,

Environmental Protection Agency,

Forest Service, Agriculture, Bureau of

Land Management, Interior, California

State Resources Agency, California State

Department of Forestry and Fire

Protection, California State Department

of Fish and Game.

ACTION: Notice of additional public

scoping meeting and extension of

scoping comment period.

SUMMARY: As specified in the official

Notice of Intent (FR, Vol. 61, No. 250,

p. 68285), five public scoping meetings

were scheduled and all scoping

comments to the notice were requested

to be received by February 10, 1997.

This present Notice announces that a

sixth public scoping meeting has been

scheduled and the above agencies

request all scoping comments to this

notice be received by February 18, 1997.

The sixth public scoping meeting has

been scheduled for Tuesday, February

11, 1997, Radisson Plaza Hotel, 1400

Parkview Avenue, Manhattan Beach,

California, from 1 p.m. to no later than

4 p.m., and from 6 p.m. to no later than

9 p.m.

ADDRESSES: Comments regarding the

scope of the EIS should be addressed to

Mr. Bruce Halstead, U.S. Fish and

Wildlife Service, 1125 16th Street,

Room 209, Arcata, CA 95521–5582.

Comments should be received on or

before February 18, 1997, at the above

address. Written comments may also be

sent by facsimile to (707) 822–8136.

Comments received will be available for

public inspection by appointment

during normal business hours (8:00 a.m.

to 5:00 p.m., Monday through Friday) at

the above office; please call for an

appointment.

FOR FURTHER INFORMATION CONTACT:

Dennis Mackey, U.S. Fish and Wildlife

Service, 911 NE 11th Avenue, Portland,