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.

Federal Register / Vol. 66, No. 27 / Thursday, February 8, 2001 / Notices 9587

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Negative Case

Action (NCA) Process/Annual Report;

Form No.: HCFA–6401 (OMB# 0938–

0300); Use: HCFA uses the NCA process

to determine the accuracy of ineligible

determinations focusing on the reason(s)

for denial or the termination of

assistance. The results of NCA reviews

are used by the States and the Federal

government to identify problem areas

and plan corrective action initiatives to

eliminate error causing situations;

Frequency: Annually; Affected Public:

State, local or tribal gov.; Number of

Respondents: 51; Total Annual

Responses: 51; Total Annual Hours:

6770.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Julie Brown, HCFA–6401,

Room N2–14–26, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: January 23, 2001.

John P. Burke III,

Reports Clearance Officer, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–3230 Filed 2–7–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–0299]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, DHHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: A Project to

Develop an Outcome-Based Continuous

Quality Improvement System for PACE;

Form No.: HCFA–R–0299 (OMB #0938–

0791); Use: The purpose of this project

is to develop an out-come based

continuous quality improvement

(OBCQI) approach for the PACE

program by (a) developing and testing

potential outcome measures, (b) testing

risk adjustment methods so that each

site’s outcomes can be appropriately

evaluated, and (c) designing an OBCQI

approach to improve quality in a

systematic, evolutionary manner.

Findings from this project are intended

to guide the possible implementation of

a national approach for OBCQI, in

which PACE sites will collect data that

will be used to determine and profile

participant outcomes for their site;

Frequency: On occasion; Affected

Public: Not-for-profit institutions,

Individuals or households; Number of

Respondents: 8,298; Total Annual

Responses: 93,970; Total Annual Hours:

21,692.04.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Julie Brown, HCFA-R–0299,

Room N2–14–26, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: January 18, 2001.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–3232 Filed 2–7–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10004]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration, DHHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated