Federal Register / Vol. 60, No. 96 / Thursday, May 18, 1995 / Notices 26731

3. Deadlines

A. Applications shall be considered as

meeting a deadline if they are either:

1. Received at the above address on or

before the deadline date; or

2. Sent on or before the deadline date

to the above address, and received in

time for the review process.

(Applicants must request a legibly

dated U.S. Postal Service postmark or

obtain a legibly dated receipt from a

commercial carrier or the U.S. Postal

Service. Private metered postmarks

shall not be accepted as proof of

timely mailing.)

B. Applications which do not meet

the criteria in 3.A.1. or 3.A.2. above are

considered late applications. Late

applications will not be considered in

the current competition and will be

returned to the applicant.

Where to Obtain Additional

Information

To receive additional written

information call (404) 332–4561. You

will be asked to leave your name,

address and phone number and will

need to refer to Announcement 565.

You will receive a complete program

description, information on application

procedures, and application forms.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from Georgia

L. Jang, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Mailstop E13, Atlanta, GA 30305,

telephone (404) 842–6814.

Programmatic technical assistance may

be obtained from Roy M. Fleming, Sc.D.,

Associate Director for Grants, National

Institute for Occupational Safety and

Health, Centers for Disease Control and

Prevention (CDC), 1600 Clifton Road,

NE., Building 1, Room 3053, Mailstop

D30, Atlanta, GA 30333, telephone (404)

639–3343.

Please refer to Announcement 565

when requesting information and

submitting an application.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report: Stock No. 017–001–00474–0) or

‘‘Healthy People 2000 (Summary

Report, Stock No. 017–001–00473–1)

referenced in the ‘‘Introduction’’

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Dated: May 12, 1995.

Diane D. Porter,

Acting Director, National Institute for

Occupational Safety and Health, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 95–12201 Filed 5–17–95; 8:45 am]

BILLING CODE 4163–19–P

Food and Drug Administration

[Docket No. 95N–0123]

Drug Export; ReviaTM (Naltrexone

Hydrochloride (HCl)) 50 Milligrams

(mg) Film-Coated Tablets

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Dupont Merck has filed an

application requesting approval for the

export of the human drug ReviaTM

(naltrexone HCl) 50 mg film-coated

tablets to Germany.

ADDRESSES: Relevant information on

this application may be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, and to the contact

person identified below. Any future

inquiries concerning the export of

human drugs under the Drug Export

Amendments Act of 1986 should also be

directed to the contact person.

FOR FURTHER INFORMATION CONTACT:

James E. Hamilton, Center for Drug

Evaluation and Research (HFD–310),

Food and Drug Administration, 7520

Standish Pl., Rockville, MD 20857, 301–

594–3150.

SUPPLEMENTARY INFORMATION: The drug

export provisions in section 802 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 382) provide that

FDA may approve applications for the

export of drugs that are not currently

approved in the United States. Section

802(b)(3)(B) of the act sets forth the

requirements that must be met in an

application for approval. Section

802(b)(3)(C) of the act requires that the

agency review the application within 30

days of its filing to determine whether

the requirements of section 802(b)(3)(B)

have been satisfied. Section 802(b)(3)(A)

of the act requires that the agency

publish a notice in the Federal Register

within 10 days of the filing of an

application for export to facilitate public

participation in its review of the

application. To meet this requirement,

the agency is providing notice that

Dupont Merck, Dupont Merck Plaza,

Maple Run, Centre Rd., Wilmington, DE

19805, has filed an application

requesting approval for the export of the

human drug ReviaTM (naltrexone HCl)

50 mg film-coated tablets to Germany.

The firm holds an approved new drug

application for an uncoated tablet,

however, this application is for a new

film-coated tablet formulation. This

product is used as an adjunctive

treatment of opioid dependence in

detoxified, formerly opioid dependent

individuals, and in a proposed

indication as an adjunctive treatment for

individuals with alcohol dependence

undergoing psychosocial treatment

programs. The application was received

and filed in the Center for Drug

Evaluation and Research on April 17,

1995, which shall be considered the

filing date for purposes of the act.

Interested persons may submit

relevant information on the application

to the Dockets Management Branch

(address above) in two copies (except

that individuals may submit single

copies) and identified with the docket

number found in brackets in the

heading of this document. These

submissions may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

The agency encourages any person

who submits relevant information on

the application to do so by May 30,

1995, and to provide an additional copy

of the submission directly to the contact

person identified above, to facilitate

consideration of the information during

the 30-day review period.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 802 (21 U.S.C. 382)) and under

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Center for Drug

Evaluation and Research (21 CFR 5.44).

Dated: May 4, 1995.

Gayle R. Dolecek,

Acting Director, Office of Compliance, Center

for Drug Evaluation and Research.

[FR Doc. 95–12177 Filed 5–17–95; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

National Institute of Dental Research;

Notice of Meeting of NIDR Board of

Scientific Counselors

Pursuant to Pub. L. 92–463, notice is

hereby given of a meeting of the Board

of Scientific Counselors, National

Institute of Dental Research (NIDR), on

June 7–9, 1995, in the Natcher Building,

Conference Room A, National Institutes

of Health, Bethesda, Maryland. The

meeting will be open to the public from

8:55 a.m. to recess on June 8 and from