[Federal Register Volume 64, Number 212 (Wednesday, November 3, 1999)]
[Notices]
[Pages 59783-59784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28560]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-4114]


Draft ``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availability of a draft guidance document entitled ``Guidance for 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.'' 
The draft guidance document applies to the manufacture of gene therapy 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. When finalized, the draft guidance document is intended to 
supplement 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 IND Using Retroviral Vectors, 
dated September 20, 1993.

DATES: Written comments may be submitted at any time, however, comments 
should be submitted by February 1, 2000, to ensure their adequate 
consideration in preparation of the final document.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Guidance for Industry: Supplemental 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'' 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 The draft guidance document may also be obtained by mail by 
calling the CBER Voice Information System at 1-800-

[[Page 59784]]

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 draft guidance 
document.
     Submit written comments on the draft 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 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.'' The draft 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 draft document provides 
guidance for replication competent retrovirus (RCR) testing during 
manufacture, including timing, amount of material to be tested, and 
general testing methods. The draft document also provides guidance on 
monitoring patients for evidence of retroviral infection. When 
finalized, the draft guidance document is intended to supplement the 
guidance and recommendations pertaining to RCR testing given in the 
following documents: (1) ``Guidance for Industry: Guidance for Human 
Somatic Cell Therapy and Gene Therapy'' dated March 1998 (issued on the 
Internet); and (2) letter to Sponsors of an IND Using Retroviral 
Vectors, dated September 20, 1993.
     The new recommendations are based on data and analyses generated 
by CBER and members of the gene therapy community. Public discussion 
and development of these recommendations have taken place during the 
retroviral breakout sessions at the ``1996 Gene Therapy Conference: 
Development and Evaluation of Phase I Products and Workshop on Vector 
Development'' (61 FR 18749, April 29, 1996), and the ``Forum 1997 Gene 
Therapy Conference.''
     The draft 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

     The draft guidance document is being distributed for comment 
purposes only, and is not intended for implementation at this time. 
Interested persons may submit to the Dockets Management Branch (address 
above) written comments regarding this draft guidance document. Written 
comments may be submitted at any time, however, comments should be 
submitted by February 1, 2000, to ensure adequate consideration in 
preparation of the final 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 draft 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 draft guidance 
document using the World Wide Web (WWW). For WWW access, connect to 
CBER at ``http://www.fda.gov/cber/guidelines.htm''.

    Dated: October 19, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-28560 Filed 11-2-99; 8:45 am]
BILLING CODE 4160-01-F