Federal Register / Vol. 60, No. 28 / Friday, February 10, 1995 / Notices 7975

catheter sites and other surgical

procedures as a film forming skin

preparation with persistent broad

spectrum antimicrobial activity. The

application was received and filed in

the Center for Drug Evaluation and

Research on October 21, 1994, 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 February 21,

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: January 31, 1995.

Kathy P. Miracco,

Acting Director, Office of Compliance, Center

for Drug Evaluation and Research.

[FR Doc. 95–3441 Filed 2–9–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0028]

Drug Export; Colgate TotalTM (Sodium

Fluoride USP 0.24%, Triclosan 0.30%)

Toothpaste

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Colgate-Palmolive Co. has filed an

application requesting approval for the

export of the human drug Colgate

TOTALTM (sodium fluoride USP 0.24%,

triclosan 0.30%) toothpaste 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, Center for Drug

Evaluation and Research (HFD–310),

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

Colgate-Palmolive Co., 300 Park Ave.,

New York, NY 10022–7499, has filed an

application requesting approval for the

export of the human drug Colgate

TOTALTM (sodium fluoride USP 0.24%,

triclosan 0.30%) toothpaste to Canada.

This product is indicated for fighting

cavities, plaque, tarter, and gingivitis.

The application was received and filed

in the Center for Drug Evaluation and

Research on October 12, 1994, 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 February 21,

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: January 31, 1995.

Kathy P. Miracco,

Acting Director, Office of Compliance, Center

for Drug Evaluation and Research.

[FR Doc. 95–3439 Filed 2–9–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0030]

Drug Export; Remydrial Two

Component System Containing

Dapiprazole Hydrochloride 50

Milligram (mg) in 260 mg Lyophilized

Powder and Solvent Containing 1.0 mg

Benzalkonium Chloride

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Angelini Pharmaceuticals, Inc., has

filed an application requesting approval

for the export of the human drug

Remydrial two component system

containing Dapiprazole Hydrochloride

50 milligram (mg) in 260 mg

Lyophilized powder and solvent

containing 1.0 mg Benzalkonium

Chloride in 10 milliliter (mL) bottle 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, 5600

Fishers Lane, Rockville, MD 20857,

301594–2073.

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