Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices 42577

Application No. Drug Applicant

ANDA 83–533 Diphenhydramine Hydrochloride Injection USP, 10 mg/mL Do.

ANDA 83–534 Thiamine Hydrochloride Injection USP, 100 mg/mL and 200

mg/mL

Do.

ANDA 83–535 Procaine Hydrochloride Injection USP, 1% and 2% Do.

ANDA 83–595 Testosterone Propionate Injection USP, 100 mg/mL Do.

ANDA 83–627 Lidocaine Hydrochloride Injection USP, 1% and 2% Do.

ANDA 83–654 Sterile Prednisolone Acetate Suspension USP, 25 mg/mL Do.

ANDA 83–667 Testosterone Enanthate Injection USP, 100 mg/mL and 200

mg/mL

Do.

ANDA 83–759 Sterile Hydrocortisone Acetate Sterile Suspension USP, 25

mg/mL and 50 mg/mL

Do.

ANDA 83–760 Pyridoxine Hydrochloride Injection USP, 100 mg/mL Do.

ANDA 84–355 Dexamethasone Sodium Phosphate Injection USP, 4 mg/mL

(base)

Do.

ANDA 84–401 Testosterone Cypionate Injection USP, 100 mg/mL and 200

mg/mL

Do.

ANDA 84–740 Phendimetrazine Tartrate Tablets, 35 mg (Gray) Inwood Laboratories, Inc., 909 Third Ave., New York, NY

10022–4731.

ANDA 84–741 Phendimetrazine Tartrate Tablets, 35 mg (Yellow) Do.

ANDA 84–742 Phendimetrazine Tartrate Tablets, 35 mg (Pink) Do.

ANDA 84–743 Phendimetrazine Tartrate Tablets, 35 mg (Green) Do.

ANDA 85–374 Sterile Methylprednisolone Acetate Sterile Suspension USP,

40 mg/mL

Steris Laboratories, Inc.

ANDA 85–463 Lidocaine Hydrochloride and Epinephrine Injection USP 1%;

0.01 mg/mL

Do.

ANDA 85–528 Hydroxocobalamin Injection USP, 1,000 μg/mL Do.

ANDA 85–529 Sterile Triamcinolone Diacetate Suspension USP, 40 mg/mL Do.

ANDA 85–781 Sterile Prednisolone Acetate Suspension USP, 50 mg/mL Do.

ANDA 86–052 Hydrocortisone Acetate Cream, 1% Purepac Pharmaceutical Co.

ANDA 86–507 Sterile Methylprednisolone Acetate Suspension USP, 80 mg/

mL

Steris Laboratories, Inc.

ANDA 87–192 Triamcinolone Acetonide Lotion USP, 1% Alpharma, U.S. Pharmaceuticals Div.

ANDA 87–214 Phendimetrazine (Extended-release Capsules, 105 mg) D. M. Graham Laboratories, Inc., 58 Pearl St., P.O. Box P,

Hobart, NY 13788.

ANDA 87–248 Sterile Methylprednisolone Acetate Suspension USP, 20 mg/

mL

Steris Laboratories, Inc.

ANDA 87–598 Nandrolone Decanoate Injection USP, 50 mg/mL Do.

ANDA 87–599 Nandrolone Decanoate Injection USP, 100 mg/mL Do.

ANDA 88–062 Hyrex-105 (Phendimetrazine Tartrate Extended-release Capsules, 105 mg)D. M. Graham Laboratories, Inc.

ANDA 88–305 Axotal Tablets (Butalbital and Aspirin Tablets USP) 50 mg/

650 mg

Savage Laboratories, 60 Baylis Rd., Melville, NY 11747.

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 8, 1997.

Dated: July 17, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–20871 Filed 8–6–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301)–443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Grantee Reporting Requirements for the

Rural Health Network Grant Program—

New—

The Rural Health Network Grant

Program is authorized by Section 330A

of the Public Health Service Act as

amended by the Health Centers

Consolidation Act of 1996 (Public Law

104–229). The purpose of the program is

to assist in the development of vertically

integrated networks of health care

providers in rural communities.

Grantees will be working to change the

delivery system in their service areas

and will be using the federal funds to

develop network capabilities.

Grantees will be asked to submit a

baseline report and semiannual tracking

reports which provide information on

progress towards goals and objectives of

the network, progress toward

developing the governance and

organizational arrangements for the

network, specific network activities,
42578 Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices

certain financial data related to the grant

budget, and health care services

provided by the network.

The information will be used to

evaluate progress on the grants, to

understand barriers to network

development in rural areas, to identify

grantees in need of technical assistance,

and to identify best practices in the

development of provider networks in

rural communities.

To minimize the burden on grantees,

the reports will be submitted

electronically. The estimated burden is

as follows:

Form name No. of respondents

Responses

per respondent

Total responsesHours per

response

Total hour

burden Wage cost Total hourcost

First Year (Baseline report and first semiannual report)

Baseline ..................................................... 40 1 40 2.0 80 $25 $2000

Semi-annual tracking ................................ 40 1 40 1.0 40 25 1000

Total first year burden ........................ 40 2 80 1.5 120 25 3000

Second and Subsequent Years

Semi-annual tracking ................................ 40 2 80 1.0 80 $25 $2000

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

Laura Oliven, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington,

D.C. 20503.

Dated: August 4, 1997.

Jane Harrison,

Acting Director, Division of Policy Review

and Coordination.

[FR Doc. 97–20875 Filed 8–6–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Notification of Expiring Project Periods

for Community and Migrant Health

Centers

AGENCY: Health Resources and Services

Administration, Public Health Service,

HHS.

ACTION: Notice.

SUMMARY: The Health Resources and

Services Administration (HRSA)

announces that a total of 83 Community

Health Center and Migrant Health

Center (C/MHC) grantees will reach the

end of their project periods during fiscal

year (FY) 1998. Assuming the

availability of sufficient appropriated

funds in FY 1998, it is the intent of

HRSA to continue to support health

services in these areas, given the unmet

need inherent in their provision of

services to a medically underserved

population. HRSA will open

competition for awards under section

330 of the Public Health Service (PHS)

Act (42 U.S.C. 254b(e) for CHCs and

U.S.C. 254b(g) for MHCs) to support

health services in the areas currently

served by these grants.

This notice provides interested parties

the opportunity to gather information

and decide whether to pursue Federal

funding as a C/MHC. During this

process, communication with Field

Office staff is essential (see Appendix I).

A subsequent Federal Register notice,

the HRSA Preview, will announce the

availability of funds for FY 1998.

DATES: Current grant expiration dates

vary by area throughout FY 1998.

Applications for competing

continuation grants are normally due

120 days prior to the expiration of the

current grant award.

SUPPLEMENTARY INFORMATION: The C/

MHC programs are carried out under the

authority of section 330 of the Public

Health Service Act. The program

regulations are codified in Title 42 of

the Code of Federal Regulation (CFR),

parts 51c and 56. The C/MHC programs

are designed to promote the

development and operation of

community-based primary health care

service systems in medically

underserved areas for medically

underserved populations.

The list of service areas for which a

current section 330 grant project period

expires in FY 1998 is set forth in

Appendix II. The service areas are listed

by city and county. Detailed information

about each service area, such as census

tracts, can be obtained by contacting the

appropriate PHS field office (see

Appendix I).

A project period is the total amount

of time for which a section 330 grant has

been programmatically approved. For

the purposes of this notice, grant awards

will be made for a one year budget

period and project periods will be for up

to three years.

Dated: August 4, 1997.

Claude Earl Fox,

Acting Administrator.

Appendix I—Field Office Staff

Field Office I: Bruce Riegel, Acting

Director, Division of Health Services

Delivery, DHHS—Field Office I, Rm

1826, JFK Federal Building #1401,

Boston, MA 02203

Field Office II: Ron Moss, Director,

Division of Health Services Delivery,

DHHS—Field Office II, Rm 3337, 26

Federal Plaza, New York, NY 10278

Field Office III: Bruce Riegel, Director,

Division of Health Services Delivery,

DHHS—Field Office III, Rm 10200,

MS 14, 3535 Market Street,

Philadelphia, PA 19104

Field Office IV: Marlene Lockwood,

Director, Division of Health Services

Delivery, DHHS—Field Office IV, 101

Marietta Tower, Atlanta, GA 30323

Field Office V: Martin Bree, Acting

Director, Division of Health Services

Delivery, DHHS—Field Office V, 105

West Adams Street, 17th Floor,

Chicago, IL 60603

Field Office VI: Frank Cantu, Director,

Division of Health Services Delivery,

DHHS—Field Office VI, Rm 1800,

1200 Main Tower Bldg, Dallas, TX

75202

Field Office VII: Hollis Hensley, Acting

Director, Division of Health Services

Delivery, DHHS—Field Office VII,

Federal Office Building, 601 East 12th

Street, Kansas City, MO 64106

Field Office VIII: Barbara Bailey,

Director, Division of Health Services

Delivery, DHHS—Field Office VIII,

Federal Office Building, 1961 Stout

Street, Denver, CO 80294

Field Office IX: Gordon Soares, Director,

Division of Health Services Delivery,

DHHS—Field Office IX, 50 United

Nations Plaza, San Francisco, CA

94102