57616 Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Notices

The burden estimate for this

collection of information is based on

agency records and experience over the

past 3 years. Agency personnel handling

the petitions for administrative

reconsideration of an action estimate

approximately 12 requests being

received by the agency annually, each

requiring an average of 10 hours

preparation time.

Dated: September 19, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–24538 Filed 9–22–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–0726]

Agency Information Collection

Activities; Announcement of OMB

Approval; General Licensing

Provisions: Changes to an Approved

Application, Labeling, and Revocation

and Suspension

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘General Licensing Provisions: Changes

to an Approved Application, Labeling,

and Revocation and Suspension’’ has

been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 20, 2000 (65 FR

38290), the agency announced that the

proposed information collection had

been submitted to OMB for review and

clearance under 44 U.S.C. 3507. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–0315. The

approval expires on August 31, 2003. A

copy of the supporting statement for this

information collection is available on

the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: September 19, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–24478 Filed 9–22–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1359]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Affirmation of Generally Recognized as

Safe (GRAS) Status

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by October 25,

2000.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Affirmation of Generally Recognized As

Safe (GRAS) Status (21 CFR

170.35(c)(1)) (OMB Control Number

0910–0132)—Extension

Under the authority of sections 201,

402, 409, and 701 of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 321, 342, 348, and 371), FDA

reviews petitions for affirmation as

GRAS that are submitted on a voluntary

basis by the food industry and other

interested parties. Under section 409 of

the act, the agency has the authority to

regulate food additives. Section 201(s)

of the act defines ‘‘food additive’’ and

expressly excludes from the definition

substances GRAS for use in food.

Specifically under section 201(s) of

the act, a substance is GRAS if it is

generally recognized among experts

qualified by scientific training and

experience to evaluate its safety, to be

safe through either scientific procedures

or common use in food. The act has

historically been interpreted to permit

food manufacturers to make their own

determination that use of a substance in

food is GRAS. To implement the GRAS

provisions of the act, FDA has issued

procedural regulations under

§ 170.35(c)(1) (21 CFR 170.35(c)(1)).

These regulations establish a process by

which a person may obtain FDA

concurrence with a GRAS

determination; this concurrence is

referred to as ‘‘GRAS affirmation.’’

These regulations set forth the

information to be submitted to FDA to

obtain agency concurrence that a

substance is GRAS (§ 170.35(c)(1)).

GRAS petitions are reviewed by FDA

to ascertain whether the available data

establish that the intended use of the

substance is GRAS based upon either a

history of the safe use of the substance,

or upon widely available safety data

(scientific procedures). The GRAS

affirmation process is a voluntary one,

and there is some risk that FDA may not

agree with the petitioner’s GRAS

determination. The GRAS petition

process does provide a public procedure

for coordinating GRAS determinations.

The process reduces the potential for

public health problems when

substances are marketed based upon

unwarranted safety determinations and

allows a food manufacturer to rely on

the lawful status of a substance that has

been affirmed by FDA as GRAS.

In the Federal Register of July 5, 2000

(65 FR 41472), the agency requested

comments on the proposed collection of

information. No comments were

received.

FDA estimates the burden of this

collection of information as follows: