62364 Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Notices

Contact Person: Sara M. Thornton,

Center for Devices and Radiological

Health (HFZ 460), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–2053, email: SMT@CDRH.FDA.GOV, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12396.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will discuss,

make recommendations, and vote on a

premarket approval application (PMA)

for a collagen glaucoma drainage device

for the reduction of intraocular pressure

in patients with open-angle glaucoma

uncontrolled on maximum tolerated

medical therapy. The committee will

also discuss issues related to the

development of guidance for the

postapproval study of extended wear

contact lenses used beyond 7 days.

Study design topics will include the

type of study, definition of endpoints,

and selection of participating study

sites.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by November 1, 2000. Oral

presentations from the public will be

scheduled between approximately 8:45

a.m. and 9:15 a.m. Near the end of the

committee deliberations on the PMA, an

additional 30-minute open public

session will be conducted for interested

persons to address issues specific to the

submission before the committee. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before November 1,

2000, and submit a brief statement of

the general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: October 11, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–26741 Filed 10–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–4114]

‘‘Guidance for Industry: Supplemental

Guidance on Testing for Replication

Competent Retrovirus in Retroviral

Vector Based Gene Therapy Products

and During Follow-up of Patients in

Clinical Trials Using Retroviral

Vectors;’’ Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance document

entitled ‘‘Guidance for Industry:

Supplemental Guidance on Testing for

Replication Competent Retrovirus in

Retroviral Vector Based Gene Therapy

Products and During Follow-up of

Patients in Clinical Trials Using

Retroviral Vectors’’ dated October 2000.

The guidance document applies to the

manufacture of gene therapy retroviral

vector products intended for in vivo or

ex vivo use and to followup monitoring

of patients who have received retroviral

vector products. The guidance

document announced in this notice

finalizes the draft guidance document

entitled ‘‘Guidance for Industry:

Supplemental Guidance on Testing for

Replication Competent Retrovirus in

Retroviral Vector Based Gene Therapy

Products and During Follow-up of

Patients in Clinical Trials Using

Retroviral Vectors,’’ announced in the

Federal Register of November 3, 1999.

The guidance document also

supplements the guidance document

entitled ‘‘Guidance for Industry:

Guidance for Human Somatic Cell

Therapy and Gene Therapy,’’ dated

March 1998; and a letter to sponsors of

an investigational new drug using

retroviral vectors, dated September 20,

1993.

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies of the guidance document

entitled ‘‘Guidance for Industry:

Supplemental Guidance on Testing for

Replication Competent Retrovirus in

Retroviral Vector Based Gene Therapy

Products and During Follow-up of

Patients in Clinical Trials Using

Retroviral Vectors,’’ dated October 2000

to the Office of Communication,

Training, and Manufacturers Assistance

(HFM–40), Center for Biologics

Evaluation and Research (CBER), Food

and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448. Send one self-addressed adhesive

label to assist that office in processing

your requests. The guidance document

may also be obtained by mail by calling

the CBER Voice Information System at

1–800–835–4709 or 301–827–1800, or

by fax by calling the FAX Information

System at 1–888–CBER–FAX or 301–

827–3844. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the guidance document.

Submit written comments on the

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Valerie A. Butler, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a guidance document entitled

‘‘Guidance for Industry: Supplemental

Guidance on Testing for Replication

Competent Retrovirus in Retroviral

Vector Based Gene Therapy Products

and During Follow-up of Patients in

Clinical Trials Using Retroviral Vectors’’

dated October 2000. The guidance

document applies to the manufacture of

gene therapy retroviral vector products

intended for in vivo or ex vivo use and

to followup monitoring of patients who

have received retroviral vector products.

The document provides guidance for

replication competent retrovirus (RCR)

testing during manufacture, including

timing, amount of material to be tested,

and general testing methods. The

document also provides guidance on

monitoring patients for evidence of

retroviral infection. The

recommendations are based on data and

analyses generated by CBER and

members of the gene therapy

community. The guidance document

finalizes the draft document entitled

‘‘Guidance for Industry: Supplemental

Guidance on Testing for Replication

Competent Retrovirus in Retroviral

Vector Based Gene Therapy Products

and During Follow-up of Patients in

Clinical Trials Using Retroviral

Vectors,’’ announced in the Federal

Register of November 3, 1999 (64 FR

59783). The guidance document also

supplements the guidance and

recommendations pertaining to RCR

testing given in the following

documents: (1) ‘‘Guidance for Industry:

Guidance for Human Somatic Cell

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.