7974 Federal Register / Vol. 60, No. 28 / Friday, February 10, 1995 / Notices

Technical Electronic Product Radiation

Safety Standards Committee;

Recharter

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration announces the

rechartering of the Technical Electronic

Product Radiation Safety Standards

Committee (TEPRSSC), by the

Commissioner of Food and Drugs or

designee. This notice is issued under

the Federal Advisory Committee Act of

October 6, 1972 (5 U.S.C. App. 2).

DATES: The new charter for this

committee will extend to December 24,

1996.

FOR FURTHER INFORMATION CONTACT:

Donna M. Combs, Committee

Management Office (HFA–306), Food

and Drug Administration, 12420

Parklawn Dr., Rockville, MD 20857,

301–443–2765.

Dated: February 6, 1995.

Lireka P. Joseph,

Acting Interim Deputy Commissioner for

Operations.

[FR Doc. 95–3437 Filed 2–9–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95F–0021]

M & G Ricerche S.p.A.; Filing of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that M & G Ricerche S.p.A. has filed a

petition proposing that the food additive

regulations be amended to provide for

the safe food contact use of ethylene

terephthalate-isophthalate copolymers

prepared with pyromellitic dianhydride

such that the finished copolymers

contain at least 95 weight percent of

polymer units derived from ethylene

terephthalate.

DATES: Written comments on the

petitioner’s environmental assessment

by March 13, 1995.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Richard H. White, Center for Food

Safety and Applied Nutrition (HFS–

216), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3094.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a petition (FAP

5B4444) has been filed by M & G

Ricerche S.p.A., c/o 7910 Woodmont

Ave., suite 1000, Bethesda, MD 20814.

The petition proposes to amend the food

additive regulations in § 177.1630

Polyethylene phthalate polymers (21

CFR 177.1630) to provide for the safe

food contact use of ethylene

terephthalate-isophthalate copolymers

prepared with pyromellitic dianhydride

such that the finished copolymers

contain at least 95 weight percent of

polymer units derived from ethylene

terephthalate.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations promulgated

under the National Environmental

Policy Act, (40 CFR 1501.4(b)), the

agency is placing the environmental

assessment submitted with the petition

that is the subject of this notice on

public display at the Dockets

Management Branch (address above) for

public review and comment. Interested

persons may, on or before March 13,

1995, submit to the Dockets

Management Branch (address above)

written comments. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday. FDA will also

place on public display any

amendments to, or comments on, the

petitioner’s environmental assessment

without further announcement in the

Federal Register. If, based on its review,

the agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: February 3, 1995.

Alan M. Rulis,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 95–3436 Filed 2–9–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0029]

Drug Export; Chloraprep Frepp and

Chloraprep Sepps (Chlorhexidine

Gluconate 0.5% w/v Isopropyl Alcohol

70% w/v)

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Medi-Flex Hospital Products, Inc.,

has filed an application requesting

approval for The export of the human

drug ChloraPrep Frepp and

ChloraPrep Sepps (chlorhexidine

gluconate 0.5% w/v Isopropyl Alcohol

70% w/v) 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

Medi-Flex Hospital Products, Inc., 19

Butterfield Trial Blvd., El Paso, TX

79906, has filed an application

requesting approval for the export of the

human drug ChloraPrep Frepp and

ChloraPrep Sepps (chlorhexidine

gluconate 0.5% w/v Isopropyl Alcohol

70% w/v) to Canada. This product is

indicated for the topical use on

peripheral, central venous and arterial