[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draft guidance document entitled ``Guidance for Industry: Supplemental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]
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