Federal Register / Vol. 66, No. 27 / Thursday, February 8, 2001 / Notices 9585

current good manufacturing practices

for medical devices regulation (21 CFR

part 820) may be relevant to a PMA

review and may be submitted as part of

an application. In individual instances,

records may be required as conditions to

approval to ensure the device’s

continuing safety and effectiveness.

Dated: February 2, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–3323 Filed 2–7–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96M–0311]

Agency Information Collection

Activities; Announcement of OMB

Approval; Public Health Service

Guideline on Infectious Disease Issues

in Xenotransplantation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Public Health Service Guideline on

Infectious Disease Issues in

Xenotransplantation’’ 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 October 18, 2000 (65

FR 62359), 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 0910–0456. The

approval expires on January 31, 2004. A

copy of the supporting statement for this

information collection is available on

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

ohrms/dockets.

Dated: February 2, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–3320 Filed 2–7–01; 8:45 am]

BILLING CODE: 3510–22–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–0239]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Request

for Resolution of Scientific Disputes

Concerning the Regulation of Medical

Devices

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 March 12,

2001.

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.

Request for Resolution of Scientific

Disputes Concerning the Regulation of

Medical Devices

Section 404 of the Food and Drug

Administration Modernization Act of

1997 (FDAMA) is intended to ensure

that FDA has effective processes to

resolve the scientific disputes that

occasionally arise between FDA and the

regulated industry. Section 404 of

FDAMA added new section 562 to the

Federal Food, Drug, and Cosmetic Act

(the act) which requires FDA to

establish, by regulation, a procedure

under which a person who is a sponsor,

applicant, or manufacturer may request

a review of a scientific controversy,

when no other provision of the act or

regulation provides such review.

In a final rule issued in the Federal

Register of November 18, 1998 (63 FR

63978), FDA amended 21 CFR 10.75 to

reflect the provisions of FDAMA. Each

affected FDA center is responsible for

developing and administering its own

processes for handling requests for

section 404 of FDAMA reviews and is

issuing a guidance document containing

specific information of the type

suggested by the comments. The draft

guidance document outlines the

requirements for persons who are

sponsors, applicants, or manufacturers

of medical devices and who wish to file

a request for a review of a scientific

dispute by the panel as set out in the

guidance. Persons filing a request for

review should provide a Center for

Devices and Radiological Health

ombudsman with a concise summary of

the scientific issue in dispute, including

a summary of the particular FDA action

or decision to which the requesting

party objects, any prior advisory panel

action and the results of all efforts that

have been made to resolve the dispute,

and a clear articulated summary of the

arguments and relevant data and

information. They may also provide

material outside the official

administrative record and not in the

possession of FDA at the time the

decision or action in dispute was made

if it has a significant bearing on the

issue or related public health

considerations. The information that is

collected will form the basis for

resolving the dispute between the

requester and FDA.

The likely respondents to this

collection of information are medical

device sponsors, applicants, or

manufacturers who have a scientific

dispute with FDA and who request a

review of the matter by the Medical

Devices Dispute Resolution Panel.

In the Federal Register of April 27,

1999 (64 FR 22617), the agency

requested comments on the proposed

collection of information. No comments

concerning the information collection

were received.

FDA estimates the burden of this

collection of information as follows:

9586 Federal Register / Vol. 66, No. 27 / Thursday, February 8, 2001 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

6 1 6 20 120

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

The Medical Devices Dispute

Resolution Panel represents a new

process for resolving scientific disputes.

In arriving at the estimates in table 1 of

this document for the burden imposed

in connection with a request for review

by the Medical Devices Dispute

Resolution Panel, FDA considered the

number and substance of similar

appeals of various types made to FDA

in recent years, knowledge of similar

submissions, and discussions with

manufacturers.

Dated: February 2, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–3319 Filed 2–7–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1604]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; OTC Test

Sample Collection Systems for Drugs

of Abuse Testing

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 March 12,

2001.

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.

OTC Test Sample Collection Systems

for Drugs of Abuse Testing—21 CFR

Part 809 (OMB Control Number 0910–

0368)—Extension

FDA has reclassified over-the-counter

(OTC) test sample collection systems for

drugs of abuse testing from class III

(premarket approval) into class I

(general controls) subject to restrictions

established in accordance with section

520(e) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 360j)(e).

The labeling requirements for certain

in vitro diagnostic products require that

manufacturers of OTC test sample

collection systems for drugs of abuse

testing provide certain information to

consumers for the proper use of the test

sample collection system and for

interpreting the results. The purpose of

this regulation is to ensure that lay

persons collecting samples for testing

have adequate instructions for sample

collection and handling and for

receiving and understanding the test

results reported by laboratories

performing the analyses.

The most likely respondents to this

information collection will be

manufacturers of over-the-counter drugs

of abuse test kits.

In the Federal Register of November

16, 2000 (65 FR 69314), 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:

TABLE1.—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section No. of respondents Annual frequency

per response

Total annual

responses Hours per response Total Hours

809.10 20 1 20 100 2,000

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

Based upon submissions to the agency

(premarket notifications, premarket

approval applications, registration and

listing), FDA estimates that there will be

about 20 manufacturers of these devices.

FDA estimates, based upon

discussions with manufacturers of

similar devices required to comply with

21 CFR 809.10, that it will take

approximately 40 hours to gather the

information required by the rule, 40

hours to design and prepare the

labeling, and an additional 20 hours per

year to review and revise the labeling as

necessary.

Dated: February 2, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–3322 Filed 2–7–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration,

DHHS.

[Document Identifier: HCFA–6401]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration.