14762 Federal Register / Vol. 60, No. 53 / Monday, March 20, 1995 / Notices

FOR FURTHER INFORMATION CONTACT:

Sandra M. Peay or Renee A. Horton,

Contact Representatives, Federal Trade

Commission, Premerger Notification

Office, Bureau of Competition, Room

303, Washington, D.C. 20580, (202) 326–

3100.

By Direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 95–6752 Filed 3–17–95; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0069]

Drug Export; Pepcid AC (Famotidine

10 Milligram (mg)) Compressed

Chewable Tablets (CCT)

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Merck & Co. has filed an

application requesting conditional

approval for the export of the human

drug Pepcid AC (Famotidine 10 mg)

Compressed Chewable Tablets (CCT) to

Canada.

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 (HFD–310), Center

for Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2073.

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

Merck & Co., BLA–30, West Point, PA

19486, has filed an application

requesting conditional approval for the

export of the human drug Pepcid AC

(Famotidine 10 mg) Compressed

Chewable Tablets (CCT) to Canada. This

product is indicated for the treatment

and prevention of heartburn. The firm

does have new drug application

approval for various other dosage forms

and strengths of Pepcid. The application

was received and filed in the Center for

Drug Evaluation and Research on

February 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 March 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: March 8, 1995.

Betty L. Jones,

Acting Deputy Director, Office of Compliance,

Center for Drug Evaluation and Research.

[FR Doc. 95–6727 Filed 3-17–95; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Maternal and Child Health Services;

Federal Set-Aside Program; Genetic

Services and Maternal and Child

Improvement Projects for Fiscal Year

(FY) 1995: Cancellation of Cycle for

Certain Grants and Cooperative

Agreements; Extension of Certain

Application Deadline Dates

Notice of Availability of Funds for

Special Project Grants and Cooperative

Agreements; Maternal and Child Health

Services; Federal Set-Aside Program;

Genetic Services and Maternal and

Child Improvement Projects for fiscal

year (FY) 1995, section 502(a), title V of

the Social Security Act, was published

on February 13, 1995, at 60 FR 8244.

Section 4.1.2.1. of this notice

announced the availability of funds for

2 grants in the Maternal, Infant, Child

and Adolescent Health category priority

identified as ‘‘Content and Organization

of Care for Women of Childbearing Age,

Infants, Children, Adolescents, and their

Families.’’ Section 4.2.3. of the notice

announced the availability of funds for

up to four cooperative agreements in the

Childhood Injury Prevention category.

Since publication of this notice, it has

been determined that amounts allocated

for grants under Section 4.1.2.1. are

insufficient to permit a competitive

grant cycle in the ‘‘Content and

Organization of Care’’ priority for FY

1995. As a result, this competition is

herewith canceled. Additionally, the

Department has decided that it prefers

to implement contracts rather than

award cooperative agreements in order

to acquire the work it wishes to have

accomplished by the centers described

in the Section 4.2.3. Childhood Injury

Prevention category. This competition is

also herewith canceled. It is anticipated

that contracts for this purpose will be

awarded during the second quarter of

FY 1996; a request for proposals will be

advertised at the appropriate time. To

ensure continuity in this activity until

then, the cooperative agreements with

existing Childhood Injury Prevention

centers will be extended for six months,

through February 1996.

Two of the deadline dates announced

in the February 13, Notice of

Availability of Funds for Special Project

Grants and Cooperative Agreements;

Maternal and Child Health Services;

Federal Set-Aside Program; Genetic

Services and Maternal and Child

Improvement Projects for fiscal year

(FY) 1995, are being extended. The

deadline date for the remaining grants

announced under Section 1.2.1. is

hereby extended to May 10, 1995. In