32672 Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices

Under OMB information collection

0910–0073, Current Good

Manufacturing Practices (CGMP) for

Medical Devices, there were 375,266

hours approved for recordkeeping

information collections contained in

part 820. These hours included 114,882

burden hours as a one time start up

expenditure for 650 new firms. The

additional requirements contained in

Current Good Manufacturing Practice;

Quality system (CGMP/QS) regulation

will add 3,527,901 burden hours to the

burden, resulting in a total

recordkeeping burden of 3,903,169

hours. The 3,527,901 burden hours

includes 1,433,579 burden hours for a

one time start up expenditure for 7,237

manufacturers and 2,094,321 burden

hours expended annually by 7,237

manufacturers.

The recordkeeping estimate includes

approximately 9.6 times as many

manufacturers with a one time start up

expenditure, due to the addition of the

design control requirements. Further,

the recordkeeping burden hour

calculations were estimated using a

complex methodology involving the

estimated noncompliance ratio for

small, medium, large, and very large

manufacturers multiplied by the

number of manufacturers in each

category. These calculations factor in a

rate of product innovation for new

products, including 510(k) devices.

Approximately 85 percent of the

additional burden hours for CGMP/QS

regulation originate from the following

four subparts of part 820: (1) Subpart

B—Quality System Requirements; (2)

Subpart C—Design controls; (3) Subpart

E—Purchasing Controls; and (4) Subpart

J—Corrective and Preventive Action.

Over 45 percent of the 3,527,901 burden

hours are attributed directly to the

addition of design control requirements.

The purchasing control requirements

and the respective recordkeeping

burden are approximately 8 percent of

the additional recordkeeping burden.

Dated: June 8, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15812 Filed 6–12–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0390]

BASF Corp.; Filing of Food Additive

Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that BASF Corp. has filed a petition

proposing that the food additive

regulations be amended to provide for

the safe use of 2,9-dimethylanthra[2,1,9-

def:6,5,10-d′e′f′]diisoquinoline1,3,8,10(2H,9H)-tetrone, (C.I. Pigment

Red 179) as a colorant for all 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 8B4596) has been filed by

BASF Corp., 3000 Continental Dr.

North, Mt. Olive, NJ 07828–1234. The

petition proposes to amend the food

additive regulations in § 178.3297

Colorants for polymers to provide for

the safe use of 2,9-dimethylanthra[2,1,9-

def:6,5,10-d′e′f′]diisoquinoline1,3,8,10(2H,9H)-tetrone, (C.I. Pigment

Red 179) as a colorant for all polymers

intended for use in contact with food.

The agency has determined under 21

CFR 25.32(i) 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: May 28, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–15765 Filed 6–12–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food And Drug Administration

[Docket No. 98F–0391]

BASF Corp.; Filing of Food Additive

Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that BASF Corp. has filed a petition

proposing that the food additive

regulations be amended to provide for

the safe use of 2,9-bis[4-

(phenylazo)phenyl]anthra[2,1,9-

def:6,5,10-d′e′f′]diisoquinoline1,3,8,10(2H,9H)-tetrone, (C.I. Pigment

Red 178) as a colorant for all 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 8B4595) has been filed by

BASF Corp., 3000 Continental Drive

North, Mt. Olive, NJ 07828–1234. The

petition proposes to amend the food

additive regulations to provide for the

safe use of 2,9-bis[4-

(phenylazo)phenyl]anthra[2,1,9-

def:6,5,10-d′e′f′]diisoquinoline1,3,8,10(2H,9H)-tetrone, (C.I. Pigment

Red 178) as a colorant for all 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: May 28, 1998.

Laura M. Tarantino,

Acting Director, Center for Food Safety and

Applied Nutrition.

[FR Doc. 98–15767 Filed 6–12–98; 8:45 am]

BILLING CODE 4160–01–F