21194 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Notices

seafood product freshness.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

June 10, 1996, 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: April 22, 1996.

George H. Pauli,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 96–11512 Filed 5–8–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 92F–0219]

Transcommerz AG; Withdrawal of

Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 2B4325), filed by Transcommerz

AG, proposing that the food additive

regulations be amended to provide for

the safe use of α-hydro-ω-hydroxypoly-

(oxytetramethylene), diphenylmethane

diisocyanate, 1,4-butanediol,

ethylenediamine, 1,3-

benzenedimethanamine,

diethanolamine, and 1,3,5-tris(4-tertbutyl-3-hyroxy-2,6-dimethylbenzyl)-

1,3,5-triazine-2,4,6-(1H,3H,5H)trione as

components of a polyurethane

elastomer; and dimethyl-polysiloxane,

α-(ρ-nonylphenyl)-ωhydroxypoly(oxyethylene), and parrafin

oil as components of sizing and

finishing oils for the polyurethane

elastomer in food-contact articles used

in the processing and packaging of food,

including meat and poultry.

FOR FURTHER INFORMATION CONTACT:

Andrew J. Zajac, Center for Food Safety

and Applied Nutrition (HFS–216), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3095.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

July 9, 1992 (57 FR 30496), FDA

announced that a food additive petition

(FAP 2B4325) had been filed by

Transcommerz AG, c/o 7300 West

Camino Real, Boca Raton, FL 33433.

The petition proposed to amend the

food additive regulations to provide for

the safe use of α-hydro-ω-hydroxypoly-

(oxytetramethylene), diphenylmethane

diisocyanate, 1,4-butanediol,

ethylenediamine, 1,3-

benzenedimethanamine,

diethanolamine, and 1,3,5-tris(4-tertbutyl-3-hyroxy-2,6-dimethylbenzyl)-

1,3,5-triazine-2,4,6-(1H,3H,5H)trione as

components of a polyurethane

elastomer; and dimethyl-polysiloxane,

α-(ρ-nonylphenyl)-ωhydroxypoly(oxyethylene), and parrafin

oil as components of sizing and

finishing oils for the polyurethane

elastomer in food-contact articles used

in the processing and packaging of food,

including meat and poultry.

Transcommerz AG has now withdrawn

the petition without prejudice to a

future filing (21 CFR 171.7).

Dated: April 23, 1996.

Eugene C. Coleman,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 96–11513 Filed 5–8–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95S–0181]

U.S.–European Union Mutual

Recognition Agreement Activities;

Pharmaceutical GMP’s and Medical

Devices; Establishment of a Public

Docket

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

establishment of a public docket

through which it will make available

information concerning its participation

in bilateral Mutual Recognition

Agreement (MRA) talks in the areas of

pharmaceutical GMP’s and medical

devices being led by the Office of the

U.S. Trade Representative (USTR) and

the Department of Commerce (DOC) and

by representatives of the European

Commission.

ADDRESSES: Documents concerning

FDA’s bilateral MRA talks are available

for public examination in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857, between 9 a.m. and 4 p.m.,

Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Walter M. Batts, Office of International

Affairs (HFY–50), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–4480.

SUPPLEMENTARY INFORMATION: The U.S.

Government, led by USTR and DOC, is

engaged in formal talks with the

European Union (EU), led by

Directorate-General I (External

Relations) of the European Commission.

The EU initiated these talks to facilitate

access to foreign markets for their

products and to facilitate access to the

EU market for foreign products. The EU

indicated that the latter purpose was in

response to concerns raised by foreign

countries, including the United States,

that the ‘‘Single Internal Market by

1992’’ program would result in a

‘‘fortress Europe’’ that would

disadvantage foreign firms. The EU is

also pursuing separate MRA talks with

other countries, including Canada,

Australia, and Japan.

As a result of an EU request to

identify products to be covered by the

MRA talks and their proposal that

pharmaceuticals and medical devices be

included, the U.S. Government with

support by the industry agreed that

pharmaceuticals, GMP’s, and medical

devices should be among those areas

included in the talks. FDA’s discussions

with the EU cover GMP’s for human and

animal drugs, human biologicals, and

medical devices.

In 1989, prior to the initiation of the

MRA talks by Directorate-General I,

USTR, and DOC, FDA and DirectorateGeneral III (Industrial Affairs) of the

European Commission decided to begin

discussions that may lead to an

agreement in the pharmaceutical good

manufacturing practices (GMP’s) and

medical devices area. FDA’s primary

motivation in seeking such an

agreement was at that time, and still is,

a desire to most effectively utilize

limited resources. FDA recognized the