57614 Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Notices

Dated: September 19, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–24477 Filed 9–22–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0472]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Petition for

Administrative Stay 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 filing a petition for

administrative stay of 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. 3501093520), 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 an

existing 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 Stay of

Action—21 CFR 10.35 (OMB Control

Number 0910–0194)—Reinstatement)—

Extension

The regulations in 21 CFR 10.35,

issued under the authority of 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 file a

petition for an administrative stay of

action.

Respondents to this information

collection are interested persons who

choose to file a petition for an

administrative stay of action. Such a

petition must: (1) Identify the decision

involved; (2) state the action requested,

including the length of time for which

a stay is requested; and (3) include a

statement of the factual and legal

grounds on which the interested person

relies in seeking the stay. The

information provided in the petition is

used by the agency to determine

whether the requested stay should be

granted.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section No. of

respondents

Annual

frequency per

response

Total annual

responses

Hours per

response Total hours

10.35 .................................................................................... 13 1 13 10 130

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

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.