[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availability of a draft guidance document entitled ``Guidance for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The draft guidance document applies to the manufacture of gene therapy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 When finalized, the draft guidance document is intended to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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Guidance for Industry: Supplemental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 The draft guidance document may also be obtained by mail by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
