Federal Register / Vol. 66, No. 94 / Tuesday, May 15, 2001 / Notices 26869

recommendations in VICH GL9 when

differences among the guidances occur.

This Level 1 final guidance is being

issued consistent with FDA’s good

guidance practices (21 CFR 10.115; 65

FR 56468, September 19, 2000). This

guidance document represents FDA’s

current thinking on design and conduct

of all clinical studies of veterinary

products in the target species. It does

not create or confer any rights for or on

any person, and does not operate to

bind FDA or the public. An alternative

method may be used as long as it

satisfies the requirements of applicable

statutes and regulations.

Information collected is covered

under OMB control number 0910–0032.

III. Electronic Access

Copies of the final guidance

documents entitled ‘‘Good Clinical

Practice’’ (VICH GL9) may be obtained

on the Internet from the CVM home

page at http://www.fda.gov/cvm.

Comments may also be submitted

electronically on the Internet at http://

www.fda.gov/dockets/ecomments. Once

on this Internet site, select ‘‘99D–2406

Good Clinical Practice’’ and follow the

directions.

IV. Comments

As with all of FDA’s guidances, the

public is encouraged to submit written

comments with new data or other new

information pertinent to this final

guidance. FDA will periodically review

the comments in the docket and, where

appropriate, will amend this guidance.

The agency will notify the public of any

such amendments through a notice in

the Federal Register.

Interested persons may submit to the

Dockets Management Branch (address

above) written or electronic comments

regarding this final guidance document

at any time. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments should be identified with the

docket number found in brackets in the

heading of this document. A copy of

this final guidance document and

received comments are available in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: May 7, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12092 Filed 5–14–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–R–235]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

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: Data

Use Agreement and Information

Collection Requirements, model

language, and Supporting Regulations in

45 CFR, part 5b;

Form No.: HCFA–R–235 (OMB#

0938–0734);

Use: This agreement is used as a

binding agreement stating conditions

under which HCFA will disclose and

user will maintain HCFA data that are

protected by the Privacy Act.;

Frequency: On occasion;

Affected Public: Not-for-profit

institutions;

Number of Respondents: 1,500;

Total Annual Responses: 1,500;

Total Annual Hours: 750.

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: Dawn Willinghan, HCFA–R–

235, Room N2–14–26, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: April 24, 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. 01–12203 Filed 5–14–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Special Projects of National

Significance; Targeted HIV Outreach

and Intervention Model Development;

Evaluation and Program Support

Center

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Correction.

In the Federal Register of April 13,

2001, appearing on page 19180, second

column, line 21 is an incorrect website

to locate the guidance. The correct

HRSA web site for the guidance should

read, www.hab.hrsa.gov/grants.html.

Dated: May 9, 2001.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 01–12180 Filed 5–14–01; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Committee; Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Public Law 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of June 2001.

Name: Maternal and Child Health Research

Grants Review Committee.

Date and Time: June 20–22, 2001; 8 am–

5 pm.

26870 Federal Register / Vol. 66, No. 94 / Tuesday, May 15, 2001 / Notices

Place: Holiday Inn Bethesda, 8120

Wisconsin Avenue, Bethesda, Maryland

20814.

The meeting is open to the public on

Wednesday, June 20, 2001, from 9 a.m.–10

a.m., and closed for the remainder of the

meeting.

Purpose: To review research grant

applications in the program areas of maternal

and child health, administered by the

Maternal and Child Health Bureau, Health

Resources and Services Administration.

Agenda: The open portion of the meeting

will cover opening remarks by the Director,

Division of Research, Training and

Education, who will report on program

issues, congressional activities, and other

topics of interest to the field of maternal and

child health. The meeting will be closed to

the public on Wednesday, June 20, 2001,

from 10 a.m. to the remainder of the meeting

for the review of grant applications. The

closing is in accordance with the provisions

set forth in section 552b(c)(6), Title 5 U.S.C.,

and the Determination by the Associate

Administrator for Management and Program

Support, Health Resources and Services

Administration, pursuant to Public Law 92–

463.

Anyone wishing to obtain a roster of

members, minutes of meetings, or other

relevant information should write or contact

Gontran Lamberty, Dr. P.H., Executive

Secretary, Maternal and Child Health

Research Grants Review Committee, Room

18A–55, Parklawn Building, 5600 Fishers

Lane, Rockville, Maryland 20857, Telephone

(301) 443–2190.

Dated: May 9, 2001.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 01–12181 Filed 5–14–01; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Submission for OMB Review;

Comment Request; Enhancing Access

and Measuring the Effectiveness of

HIV/AIDS Information Methods

SUMMARY: Under the provisions of

Section 3507(a)(1)(D) of the Paperwork

Reduction Act of 1995, the National

Library of Medicine (NLM), the National

Institutes of Health (NIH) has submitted

to the Office of Management and Budget

(OMB) a request to review and approve

the information collection listed below.

This proposed information collection

was previously published in the Federal

Register on May 5, 2000, in Volume 65,

No. 88, page 26220 and allowed 60 days

for public comment. No public

comments were received. The purpose

of this notice is to allow an additional

30 days for public comment. The

National Library of Medicine may not

conduct or sponsor, and the respondent

is not required to respond to, an

information collection that has been

extended, revised, or implemented on or

after October 1, 1995, unless it displays

a currently valid OMB control number.

Proposed Collection

Title: Enhancing Access and

Measuring the Effectiveness of HIV/

AIDS Information Methods. Type of

Information Collection Request: New.

Need and Use of Information Collection:

This study will assess the effectiveness

of three information sources within the

African American Community in

disseminating HIV prevention

information. HIV infection and the

dissemination of prevention information

is a major public health task in North

Florida. Three types of African

American communities from Gadsden,

Leon, and Duval counties are selected as

the sites of this study. This will include

communities with rural, mixed rural/

urban, and urban areas represented for

assessing possible differences in health

information channel preferences. This

study will add to the body of knowledge

concerning HIV information

dissemination to African American

communities in two ways: first, by

assessing whether there are differences

in the preferred health information

channels of those living in rural, mixed,

and urban areas; and secondly, by

assessing three information

dissemination channels for

communicating HIV issues to African

American communities. The three

information channels of concern in this

study are community newsletters,

entertainment education, and church

ministries. In the first year of the

project, a brief survey will be conducted

before and after distribution of the

community newsletter to assess how the

community obtains information about

the prevention of HIV infection and

transmission, their preferred sources of

health information, and the

effectiveness of the newsletter. The

initial data collected will be used to

establish a baseline for the project

against which the subsequent project

data can be evaluated.

Frequency of Response: On occasion.

Affected Public: Individuals or

households. Type of Respondents:

Residents living in Duval, Gadsden and

Leon counties, Florida. The annual

reporting burden is as follows:

Estimated Number of Respondents: 360;

Estimated Number of Responses per

Respondent: 1; Average Burden Hours

Per Response: .334 and Estimated Total

Annual Burden Hours Requested: 120.

The annualized cost to respondents is

estimated at: $844.80. There are no

Capital Costs to report. There are no

Operating or Maintenance Costs to

report.

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

are invited on one or more of the

following points: (1) Whether the

proposed collection of information is

necessary for the proper performance of

the function of the agency, including

whether the information will have

practical utility; (2) The accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (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 those who are to respond, including

the use of appropriate automated,

electronic, mechanical, or other

technological collection techniques or

other forms of information technology.

Direct Comments to OMB

Written comments and/or suggestions

regarding the item(s) in this notice,

especially regarding the estimated

public burden and associated response

time, should be directed to the: Office

of Management and Budget, Office of

Regulatory Affairs, New Executive

Office Building, Room 10235,

Washington, DC 20503, Attention: Desk

Officer for NIH. To request more

information on the proposed collection

of information contact: Cynthia B. Love,

National Library of Medicine, Building

38A, Room 3N–311C, 8600 Rockville

Pike, Bethesda, MD 20894, or call nontoll free number (301) 496–5306. You

may also e-mail your request to:

cindy_love@nlm.nih.gov.

Comments Due Date

Comments regarding this information

collection are best assured of having

their full effect if received on or before

June 14, 2001.

Dated: May 7, 2001.

Donald C. Poppke,

Associate Director for Administrative

Management, National Library of Medicine.

[FR Doc. 01–12123 Filed 5–14–01; 8:45 am]

BILLING CODE 4140–01–M