Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Notices 57615

The burden estimate for this

collection of information is based on

FDA’s experience with petitions for

administrative stay of action over the

past 3 years. Agency personnel

responsible for processing the filing of

petitions for administrative stays of

action estimate that 13 such petitions

are received by the agency annually,

with each requiring approximately 10

hours of preparation time.

Dated: September 19, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–24537 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–1511]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Petition for

Administrative Reconsideration of

Action

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

requirements for parties filing a petition

for administrative reconsideration of an

action.

DATES: Submit written or electronic

comments on the collection of

information by November 24, 2000.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. All

comments should be identified with the

docket number found in brackets in the

heading of this document.

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: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of a

collection of information, before

submitting the collection to OMB for

approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Petition for Administrative

Reconsideration of Action—21 CFR

10.33 (OMB Control Number 0910–

0192)—Extension

The regulations in 21 CFR 10.33,

issued under section 701(a) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 371(a)), set forth the format

and procedures by which an interested

person may petition the Commissioner

of Food and Drugs (the Commissioner)

for reconsideration of an agency action.

A petition for reconsideration must

contain a full statement in a wellorganized format of the factual and legal

grounds upon which the petition relies.

The grounds must demonstrate that

relevant information and views

contained in the administrative record

were not previously or adequately

considered by the Commissioner. Each

petition must be submitted no later than

30 days after the decision involved. The

Commissioner may, for good cause,

permit a petition to be filed after 30

days. An interested person who wishes

to rely on information or views not

included in the administrative record

shall submit them with a new petition

to modify the decision. FDA uses the

information provided to determine

whether to grant the petition for

reconsideration. Respondents to this

collection of information are individuals

of households, State or local

governments, not-for-profit institutions,

and businesses or other for-profit

institutions.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR section Number of

respondents

Annual frequency per

response

Total annual

responses Hours per response Total hours

10.33(b) 12 1 12 10 120

1There are no capital costs or operating and maintenance costs associated with this collection of information.

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: