40720 Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0593]

Dover Chemical Corp.; Filing of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Dover Chemical Corp. has filed a

petition proposing that the food additive

regulations be amended to provide for

the safe use of 3,9-bis[2,4-bis(1-methyl1-phenylethyl)phenoxy]-2,4,8,10-

tetraoxa-3,9-

diphosphaspiro[5.5]undecane, which

may contain not more than 2 percent by

weight of triisopropanolamine, as an

antioxidant and/or stabilizer for

polymers intended for use in contact

with food.

FOR FURTHER INFORMATION CONTACT:Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215),Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

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 food additive

petition (FAP 8B4614) has been filed by

Dover Chemical Corp., 3676 Davis Rd.

NW., Dover, OH 44622. The petition

proposes to amend the food additive

regulations in § 178.2010 Antioxidants

and/or stabilizers for polymers (21 CFR

178.2010) to provide for the safe use of

3,9-bis[2,4-bis(1-methyl-1-

phenylethyl)phenoxy]-2,4,8,10-tetraoxa3,9-diphosphaspiro[5.5]undecane,

which may contain not more than 2

percent by weight of

triisopropanolamine, as an antioxidant

and/or stabilizer for polymers intended

for use in contact with food.

The agency has determined under 21

CFR 25.32(i) that this action is of the

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: July 11, 1998.

George H. Pauli,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–20359 Filed 7–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 83F–0089]

National Starch and Chemical Corp.;

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 3B3696) proposing that the food

additive regulations be amended to

provide for the safe use of the partial

sodium salt of a copolymer of

dimethyldiallylammonium chloride

with acrylamide and acrylic acid as a

component of paper and paperboard for

use in contact with food.

FOR FURTHER INFORMATION CONTACT:

Daniel N. Harrison, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,

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

202–418–3084.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

April 22, 1983 (48 FR 17390), FDA

announced that a food additive petition

(FAP 3B3696) had been filed by

National Starch and Chemical Corp.,

P.O. Box 6500, Bridgewater, NJ 08807–

0500. The petition proposed to amend

the food additive regulations in

§ 176.170 Components of paper and

paperboard in contact with aqueous and

fatty foods (21 CFR 176.170) to provide

for the safe use of the partial sodium salt

of a copolymer of

dimethyldiallylammonium chloride

with acrylamide and acrylic acid as a

component of paper and paperboard for

use in contact with food. National

Starch and Chemical Corp. has now

withdrawn the petition without

prejudice to a future filing (21 CFR

171.7).

Dated: July 2, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–20304 Filed 7–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0449]

‘‘Draft Compliance Program Guidance

Manual: Inspection of Medical Device

Manufacturers;’’ Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft document entitled

‘‘Draft Compliance Program Guidance

Manual: Inspection of Medical Device

Manufacturers.’’ This draft guidance

provides guidance to the FDA field staff

for the enforcement of the requirements

of the quality system regulation, and it

includes guidance on the amendments

to the quality system regulation, which

became effective June 1, 1997. This draft

guidance is intended to represent the

agency’s current thinking on inspection

of medical device manufacturers, and it

is not final nor is it in effect at this time.

DATES: Written comments may be

provided at any time, however,

comments should be submitted by

October 28, 1998.

ADDRESSES: Submit written requests for

single copies on a 3.5’’ diskette of the

guidance document entitled ‘‘Draft

Compliance Program Guidance Manual:

Inspection of Medical Device

Manufacturers’’ to the Division of Small

Manufacturers Assistance (HFZ–220),

Center for Devices and Radiological

Health, Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850.

Send one self-addressed adhesive label

to assist that office in processing your

request, or fax your request to 301–443–

8818. See the SUPPLEMENTARY

INFORMATION section for information

on electronic access to the guidance.

Submit written comments on the

document to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Wes

W. Morgenstern, Center for Devices and

Radiological Health (HFZ–305), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–4699.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft document entitled ‘‘Draft

Compliance Program Guidance Manual:

Inspection of Medical Device