26868 Federal Register / Vol. 66, No. 94 / Tuesday, May 15, 2001 / Notices

II. Comments

Interested persons may, at any time,

submit written or electronic comments

regarding the draft guidance. Written

comments should be submitted to the

Dockets Management Branch (address

above). 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. The draft guidance and

received comments are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

III. Electronic Access

Comments may also be submitted

electronically on the Internet at http://

www.fda.gov/dockets/ecomments. Once

on this Internet site, select the relevant

‘‘docket number’’ and follow the

directions. Copies of this draft guidance

for industry are available on the Internet

at http://www.fda.gov/cder/guidance/

index.htm.

Dated: May 7, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12179 Filed 5–14–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–2406]

International Cooperation on

Harmonisation of Technical

Requirements for Registration of

Veterinary Medicinal Products (VICH);

Final Guidance for Industry entitled

‘‘Good Clinical Practice’’ (VICH GL9);

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a final guidance for

industry (No. 85) entitled ‘‘Good

Clinical Practice’’ (VICH GL9). This

guidance document has been developed

for veterinary use by the International

Cooperation on Harmonisation of

Technical Requirements for Registration

of Veterinary Medicinal Products

(VICH). The final VICH guidance is

intended to provide a unified standard

for designing, conducting, monitoring,

recording, and reporting studies used in

registration applications for approval of

veterinary products submitted to the

European Union, Japan, and the United

States.

DATES: Submit written comments at any

time. This guidance will be

implemented July 1, 2001.

ADDRESSES: Submit written requests for

a single copy of the final guidance to the

Communications Staff (HFV–12), Center

for Veterinary Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that

office in processing your requests. See

the SUPPLEMENTARY INFORMATION section

for electronic access to the final

guidance document.

Submit written comments at any time

on the final guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852,—

e-mail: fdadockets@oc.fda.gov.

FOR FURTHER INFORMATION CONTACT:

Herman M. Schoenemann (HFV–120),

Center for Veterinary Medicine, Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0220, e-mail: 3hschoene@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In recent years, many important

initiatives have been undertaken by

regulatory authorities and industry

associations to promote the

international harmonization of

regulatory recommendations. FDA has

participated in efforts to enhance

harmonization and has expressed its

commitment to seek scientifically based

harmonized technical recommendations

for the development of pharmaceutical

products. One of the goals of

harmonization is to identify and then

reduce the differences in technical

recommendations for drug development

among regulatory agencies in different

countries.

FDA has actively participated in the

International Conference on

Harmonisation of Technical

Requirements for Registration of

Pharmaceuticals for Human Use for

several years to develop harmonized

technical recommendations for the

approval of human pharmaceutical and

biological products among the European

Union, Japan, and the United States.

The VICH is a parallel initiative for

veterinary medicinal products. The

VICH is concerned with developing

harmonized technical recommendations

for the approval of veterinary medicinal

products in the European Union, Japan,

and the United States, and includes

input from both regulatory and industry

representatives.

The VICH Steering Committee is

composed of member representatives

from the European Commission; the

European Medicines Evaluation Agency;

the European Federation of Animal

Health; the U.S. FDA; the U.S.

Department of Agriculture; the Animal

Health Institute; the Japanese Veterinary

Pharmaceutical Association; the

Japanese Association of Veterinary

Biologics; and the Japanese Ministry of

Agriculture, Forestry and Fisheries.

Two observers are eligible to

participate in the VICH Steering

Committee: One representative from the

Government of Australia/New Zealand

and one representative from the

industry in Australia/New Zealand. The

VICH Secretariat, which coordinates the

preparation of documentation, is

provided by the Confe ́de ́ration

Mondiale de L’Industrie de la Sante ́

Animale (COMISA). A COMISA

representative also participates in the

VICH Steering Committee meetings.

II. Guidance on Good Clinical Practice

In the Federal Register of August 3,

1999 (64 FR 42135), FDA published the

notice of availability of the draft

guidance entitled ‘‘Good Clinical

Practices’’ (VICH GL9), giving interested

persons until September 2, 1999 to

submit comments. After considering the

comments received, FDA made

principally editorial changes. The final

guidance was submitted to the VICH

Steering Committee. At a meeting held

on June 14 through 16, 2000, the VICH

Steering Committee endorsed the final

guidance for industry, VICH GL9.

The guidance is intended to be an

international ethical and scientific

quality standard for designing,

conducting, monitoring, recording,

auditing, analyzing, and reporting

clinical studies evaluating veterinary

products. This final guidance document

is intended to be consistent with the

laws of the European Union, Japan, and

the United States.

VICH GL9 is a revision of and will

replace CVM guidance No. 58 entitled

‘‘Good Target Animal Studies Practices:

Investigators and Monitors.’’ In

addition, there are some minor conflicts

between this guidance and recent CVM

guidance No. 56 entitled ‘‘Protocol

Development Guideline for Clinical

Effectiveness and Target Animal Safety

Trials,’’ and No. 104 entitled ‘‘Guidance

for Industry: Content and Format of

Effectiveness and Target Animal Safety

Technical Sections and Final Study

Reports for Submission to the Division

of Therapeutic Drugs for Non-Food

Animals.’’ Until the center revises these

guidances, sponsors should follow the

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.