[Federal Register Volume 65, Number 202 (Wednesday, October 18, 2000)]
[Notices]
[Pages 62364-62365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26670]


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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.

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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draft guidance document entitled ``Guidance for Industry: Supplemental 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

[[Page 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