52136 Federal Register / Vol. 62, No. 193 / Monday, October 6, 1997 / Notices

505, and 701 of the Federal Food, Drug,

and Cosmetic Acts (21 U.S.C. 321, 351,

352, 355, and 371), and under the

authority delegated to Commissioner of

Food and Drugs (21 CFR 5.10) and

redelegated to the Director of the Center

for Biologics Evaluation and Research

(21 CFR 5.67).

Dated: September 17, 1997.

Kathryn C. Zoon,

Director, Center for Biologics Evaluation and

Research.

[FR Doc. 97–26454 Filed 10–3–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97C–0415]

Zauder Bros., Inc.; Filing of Color

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Zauder Bros., Inc., has filed a

petition proposing that the color

additive regulations be amended to

provide for the safe use of zinc sulfide

as a color additive in externally applied

cosmetics.

FOR FURTHER INFORMATION CONTACT:

Aydin O ̈ rstan, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3076.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 721(d)(1) (21 U.S.C. 379e(d)(1))),

notice is given that a color additive

petition (CAP 7C0251) has been filed by

Zauder Bros., Inc., c/o Schiff & Co., 1129

Bloomfield Ave., West Caldwell, NJ

07006. The petition proposes to amend

the color additive regulations to provide

for the safe use of zinc sulfide as a color

additive in externally applied

cosmetics.

The agency has determined under 21

CFR 25.32(r) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: September 11, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–26354 Filed 10–3–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95F–0040]

Chemie Research and Manufacturing

Co., Inc.; 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

filed by Chemie Research and

Manufacturing Co., Inc., proposing that

the food additive regulations be

amended to provide for the safe use of

a glycerin extract of dried grapefruit

seeds and pulp as an antimicrobial

agent in the processing of fresh or frozen

poultry, fish, and shellfish.

FOR FURTHER INFORMATION CONTACT:

Valerie M. Davis, Center for Food Safety

and Applied Nutrition (HFS–206), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3181.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

March 16, 1995 (60 FR 14286), FDA

announced that a food additive petition

(FAP 2A4336) had been filed by Chemie

Research and Manufacturing Co., Inc.,

160 Concord Dr., P.O. Box 181279,

Casselberry, FL 32718–1279. The

petition proposed that the food additive

regulations be amended to provide for

the safe use of a glycerin extract of dried

grapefruit seeds and pulp as an

antimicrobial agent in the processing of

fresh or frozen poultry, fish, and

shellfish.

By letter dated May 10, 1995, the

agency notified the petitioner that

consideration of the petitioned use for

the glycerin extract of dried grapefruit

seed and pulp would require the

submission and evaluation of specific

additional data. By letter of June 1,

1995, the petitioner provided a partial

response to the agency’s request for

information and stated an intent to

provide a complete response within 180

days. However, no further information

was submitted within the 180-day time

period.

By letter of July 24, 1996, FDA again

requested that the necessary data be

submitted within 30 days and stated

that a failure to respond would be

considered to be an agreement by the

petitioner to withdraw the petition.

Because FDA has received no response

from the petitioner, and the required

information has not been submitted, the

petition is now withdrawn without

prejudice to a future filing (21 CFR

171.7(b)). Future consideration of the

use of a glycerin extract of dried

grapefruit seeds and pulp as an

antimicrobial agent in the processing of

fresh or frozen poultry, fish, and

shellfish will require submission of a

new food additive petition.

Dated: September 22, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–26413 Filed 10–3–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97F–0412]

Mitsui Petrochemical Industries, Ltd.;

Filing of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Mitsui Petrochemical Industries,

Ltd., has filed a petition proposing that

the food additive regulations be

amended to provide for the safe use of

ethylene/propylene copolymers that

contain up to 20 mole-percent of

polymer units derived from propylene,

with the remainder of the polymer

consisting of ethylene, and having a

minimum viscosity-average molecular

weight of 95,000 and a minimum

Mooney viscosity of 13 at up to 30

percent of other regulated polymer

blends.

DATES: Written comments on the

petitioner’s environmental assessment

by November 5, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Hortense S. Macon, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,