Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Notices 62365

Therapy and Gene Therapy’’ dated

March 1998 (issued on the Internet); and

(2) letter to sponsors of an

investigational new drug using

retroviral vectors, dated September 20,

1993.

The guidance document represents

the agency’s current thinking regarding

testing for RCR in retroviral vector based

gene therapy products. 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 approach may be

used if such approach satisfies the

requirements of the applicable statute,

regulations, or both. As with other

guidance documents, FDA does not

intend this document to be all-inclusive

and cautions that not all information

may be applicable to all situations. The

document is intended to provide

information and does not set forth

requirements.

II. Comments

Interested persons may, at any time

submit written comments to the Dockets

Management Branch (address above)

regarding this guidance document. 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. A copy of the guidance

document 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

Persons with access to the Internet

may obtain the guidance document at

http://www.fda.gov/cber/

guidelines.htm.

Dated: October 5, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–26670 Filed 10–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office at (301) 443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Proposed Project: Grantee Reporting

Requirements for the Ryan White

Comprehensive AIDS Resources

Emergency (CARE) Act of 1990—Title

III (OMB 0915–0158)—Revision.

Section 2651 of the Public Health

Service (PHS) Act (commonly known as

Title III of the Ryan White

Comprehensive AIDS Resource

Emergency (CARE) Act of 1990),

provides categorical funding to increase

the capacity and capability of

organizations that provide primary

health care to HIV-related early

intervention services to medically

underserved persons who have, or are at

high risk for, HIV infection. These

services are provided as part of a

continuum of HIV prevention and

health care services.

The bulk of the information being

collected describes the epidemiologic

and demographic characteristics of the

populations receiving early intervention

services from grant recipients, and

provides the basis for the annual report

to the Secretary, which is legislatively

mandated. It is also used to monitor the

delivery of services, guide Federal

policy, and assist in program

development and evaluation.

The estimated response burden is as

follows:

Form name No. of

respondents

Responses

per

respondent

Total

responses

Average

time per

response

Total

burden

hours

TIII PDR ................................................................................................... 278 1 278 80 22,240

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

John Morrall, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington,

D.C. 20503.

Dated: October 12, 2000.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–26742 Filed 10–17–00; 8:45 am]

BILLING CODE 4160–15–U

DEPARTMENT OF THE INTERIOR

Office of the Secretary

Invasive Species Advisory Committee

AGENCY: Office of the Secretary, Interior.

ACTION: Notice of meeting of the

Invasive Species Advisory Committee.

SUMMARY: Pursuant to the provisions of

the Federal Advisory Committee Act,

notice is hereby given of meeting of the

Invasive Species Advisory Committee.

The purpose of the Advisory Committee

is to provide advice to the Council, as

authorized by Executive Order 13112,

on a broad array of issues related to

preventing the introduction of invasive

species and providing for their control

and minimizing the economic,

ecological, and human health impacts

that invasive species cause. The meeting

on October 24 will be a joint meeting of

the Advisory Committee and various

Federal Agency Officials. The meeting

on October 25 will consist of the

Advisory Committee only. Both

meetings will be open to the public.

Attendance will be limited to space

available.

DATES: Meeting of Invasive Species

Advisory Committee and Federal

Agencies: 8:00 a.m.–4:15 p.m., Tuesday

October 24, 2000; Meeting of Advisory

Committee only: 8:30 a.m.–3:00 p.m.,

Wednesday, October 25, 2000.

ADDRESSES: U.S. Fish and Wildlife

Service, National Conservation Training

Center, Shepherdstown, WV. The

October 24th meeting will be held in the

Auditorium. The October 25th meeting

will be held in the Instructional West

Building, Room 170.

FOR FURTHER INFORMATION CONTACT:

Kelsey Passe ́, National Invasive Species

Council Program Analyst; E-mail:

kelsey_passe@ios.doi.gov; Phone: (202)

208–6336; Fax: (202) 208–1526.