Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Notices 62363

7FDA estimates there are approximately 12 clinical centers doing xenotransplantation procedures x approximately 25 health care workers involved per center = 300 health care workers. 8Fifty-eight source animal records + 29 recipient records = 87 total records.

Because xenotransplantation is a

relatively new area of medical science,

potential problems and adverse effects

are not well known. Because of the

potential risk for cross-species

transmission of infectious agents from

source animals to patients, their close

contacts, and the general public and the

latency period of known human

pathogenic persistent virus, the

guideline recommends that health

records be retained for 50 years. Since

these records are medical records, they

are not considered ‘‘information’’ as that

term is defined under the PRA (5 CFR

1320.3(h)(5)). Also, because of the

limited number of clinical studies with

small patient populations, the number

of records is small and, therefore, the

capital and operating costs are expected

to be insignificant at this time.

Many of the information collections

described in this guideline are not new

and can be found under existing

regulations and, therefore, are not

included in the hour burden estimates

in tables 1 through 4 of this document.

These information collections are

included under the regulations and

approved under the OMB control

numbers as follows: (1) ‘‘Current Good

Manufacturing Practice for Finished

Pharmaceuticals,’’ 21 CFR 211.1 through

211.208, approved under OMB control

number 0910–0139; (2) ‘‘Investigational

New Drug Application,’’ 21 CFR 312.1

through 312.160, approved under OMB

control number 0910–0014; and (3)

information included in a license

application, 21 CFR 601.2, approved

under OMB control number 0910–0427.

(Although it is possible that a

xenotransplantation product may not be

regulated as a biological product (e.g., it

may be regulated as a medical device),

FDA expects, based on its knowledge

and experience with

xenotransplantation, that any

xenotransplantation product subject to

FDA regulation within the next 3 years

will most likely be regulated as a

biological product.)

TABLE 5.—COLLECTIONS OF INFORMATION UNDER CURRENT REGULATIONS

PHS Guideline

Section Description of Collection of Information Activity 21 CFR Section (unless otherwisestated)

2.2.1 Document offsite collaborations. 312.52

2.5 Sponsor ensure counseling patient + family + contacts. 312.62(c)

3.1.1 and 3.1.6 Document well-characterized health history and lineage of source animals. 312.23(a)(7)(iv)(a) and 211.84

3.1.8 Registration with and import permit from the Centers for Disease Control and Prevention.42 CFR 71.53

3.2.2 Document collaboration with accredited microbiology labs. 312.52

3.2.5, 3.4, and

3.4.1

Herd health maintenance and surveillance to be documented, available, and in accordance with documented procedures; record standard veterinary care.211.100 and 211.122

3.3.3 Validate assay methods. 211.160(a)

3.6.1 Procurement and processing of xenografts using documented aseptic conditions. 211.100 and 211.122

3.6.2 Develop, implement, and enforce SOP’s for procurement and screening processes. 211.84(d) and 211.122(c)

3.6.4 Communicate to FDA animal necropsy findings pertinent to health of recipient. 312.32(c)

3.7.1 PHS specimens to be linked to health records; provide to FDA justification for types of

tissues, cells, and plasma, and quantities of plasma and leukocytes collected.

312.23(a)(6)

4.1.1 Surveillance of xenotransplant recipient; sponsor ensures documentation of surveillance program life-long (justify > 2 yrs.); investigator case histories (2 yrs. after investigation is discontinued).312.23(a)(6)(iii)(f) and (g), and

312.62(b) and (c)

4.1.2 Sponsor to justify amount and type of reserve samples. 211.122

4.1.2.2 System for prompt retrieval of PHS specimens and linkage to medical records (recipient and source animal).312.57(a)

4.1.2.3 Notify FDA of a clinical episode potentially representing a xenogeneic infection. 312.32

4.2.2.1 Document collaborations (transfer of obligation). 312.52

4.2.3.1 Develop educational materials (sponsor provides investigators with information needed

to conduct investigation properly).

312.50

4.3 Sponsor to keep records of receipt, shipment, and disposition of investigative drug; investigator to keep records of case histories.312.57 and 312.62(b)

Dated: October 10, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–26671 Filed 10–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Ophthalmic Devices Panel of the

Medical Devices Advisory Committee;

Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Ophthalmic

Devices Panel of the Medical Devices

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on November 8, 2000, 8:30 a.m. to

5 p.m.

Location: Holiday Inn, Walker/

Whetstone Rooms, Two Montgomery

Village Ave., Gaithersburg, MD.

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