65724 Federal Register / Vol. 66, No. 245 / Thursday, December 20, 2001 / Notices

additional facts about the

remanufacturer. Specifically, FDA

stated:

FDA, however, does believe that

representations concerning the OEM may be

misleading unless the reprocessor of a single

use device provides additional information

that would indicate that the reprocessor is

the manufacturer responsible for product

problems. As you note in your petition,

hospitals and other user facilities must alert

FDA or the manufacturer whenever there is

information that ‘‘reasonably suggests that a

device has or may have caused or contributed

to the death ... [or] serious injury to a patient

...’’ 21 CFR 803.30(a). Moreover, the user or

FDA may need to know the identity of the

manufacturer, not only for the purposes of

reporting adverse events to FDA, but to

assure that the responsible manufacturer or

FDA can investigate the problem to

determine if additional steps should be

taken, including distribution of safety

information to the users, or product recalls.

Accordingly, FDA believes that when a

reprocessed product’s labeling makes

representations that suggest the OEM should

be notified of product problems, additional

information that provides the correct identity

of the reprocessor as the remanufacturer who

is responsible for adverse event reporting,

recalls, or other corrective actions, is

‘‘material’’ information within the meaning

of section 201(n) of the Act because such

information is necessary to enable FDA’s

postmarket reporting procedures under

section 519 of the Act to function effectively.

In the response to the petition, FDA

also said that it would publish a

guidance document that will

recommend more specific language and

direction to regulated industry on this

matter. Before it develops this guidance

document, FDA is inviting interested

persons to submit comments and

suggestions on the contents of such a

guidance.

The ADDM petition and FDA’s

response are available from the Dockets

Management Branch (address above).

Please reference Docket No. 01P–0148.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written or electronic comments

or suggestions regarding this issue by

March 20, 2002. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: November 28, 2001.

Linda S. Kahan,

Deputy Director, Center for Devices and

Radiological Health.

[FR Doc. 01–31334 Filed 12–19–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF THE INTERIOR

Bureau of Indian Affairs

Submission of Information Collection

to the Office of Management Budget

for Review Under the Paperwork

Reduction Act

AGENCY: Bureau of Indian Affairs,

Interior.

ACTION: Notice of renewal of a current

approved information collection.

SUMMARY: In compliance with the

Paperwork Reduction Act of 1995, this

notice announces that the Bureau of

Indian Affairs is submitting an

information collection request to the

Office of Management and Budget for

clearance and extension. The

information collection request for the

Indian Child Welfare Act Annual Report

is cleared under OMB Control Number

1076–0131 through December 31, 2001.

DATES: Submit comments on or before

January 22, 2002.

ADDRESSES: Written comments should

be sent directly to the Office of

Management and Budget, Office of

Information and Regulatory Affairs,

Attention: Desk Officer for the

Department of Interior, Room 10102,

725 17th Street NW, Washington, DC

20503.

Send a copy of your comments to

Larry Blair, Bureau of Indian Affairs,

Branch of Tribal Government, Division

of Social Services, 1849 C Street NW

(MS–4660–MIB), Washington, DC

20240.

FOR FURTHER INFORMATION CONTACT:

Interested persons may obtain copies of

the information collection requests

without charge by contacting Mr. Larry

Blair, (202) 208–2479 (this is not a toll

free number). Facsimile number (202)

208–2648.

SUPPLEMENTARY INFORMATION:

I. Abstract

The Department has issued

regulations prescribing procedures by

which an Indian tribe may receive

funding to provide ICWA services.

Funding is authorized by the Indian

Child Welfare Act, Public Law 95–608,

92 Stat. 3069, 25 U.S.C. 1918.

A Federal Register notice soliciting

comments from interested parties to

renew this information collection was

published on October 2, 2001 (66 FR

50201). No comments were received.

Upon review of ICWA program

information previously collected, we

realized that a change was needed to

more accurately reflect the public

burden. Therefore, we are submitting

this information collection for revision

and renewal. 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.

II. Request for Comments

The Department invites comments on:

(1) Whether the collection of

information is necessary for the proper

performance of the functions of the

Bureau, including whether the

information will have practical utility;

(2) The accuracy of the Bureau’s

estimate of the burden of the

information collection, 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 information collection on those who

are to respond, including through the

use of appropriate automated electronic,

mechanical, or other collection

techniques or forms of information

technology.

III. Data

Title of the Information Collection:

ICWA of 1978.

OMB: 1076–0131; Expiration date:

December 31, 2001.

Type of Review: Revision and renewal

of a current approved information

collection.

Summary of Collection of

Information: The collection of

information will ensure that the

provisions of Public Law 95–608 are

met.

Affected Entities: Federally

recognized tribes who receive grant

funding to provide ICWA services.

Frequency of Response: Quarterly.

Estimated Number of Annual

Responses: One annual and four

quarterly reports (the fourth quarter

report is also the annual report).

Estimated Time Per Response: Onehalf hour for each of 4 reports from 536

grantees.

Estimated Total Annual Burden

Hours: 1,072 hours.

This notice is published in

accordance with the authority delegated

by the Secretary of the Interior to the

Assistant Secretary—Indian Affairs by

209 Departmental Manual 8.1.

Dated: December 11, 2001.

Neal A. McCaleb,

Assistant Secretary—Indian Affairs.

[FR Doc. 01–31336 Filed 12–19–01; 8:45 am]

BILLING CODE 4310–02–P