[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69690-69691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27769]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0576]
Draft Guidance for Industry: Considerations for the Design of
Early-Phase Clinical Trials of Cellular and Gene Therapy Products;
Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is extending the
comment period for the draft guidance for industry entitled ``Guidance
for Industry: Considerations for the Design of Early-Phase Clinical
Trials of Cellular and Gene Therapy Products'' that appeared in the
Federal Register of July 2, 2013 (78 FR 39736). The draft guidance
document provides sponsors of Investigational New Drug Applications for
cellular therapy (CT) and gene therapy (GT) products (referred to
collectively as CGT products) with recommendations to assist in
designing early-phase clinical trials of CGT products. In the notice,
we requested comments on the draft guidance. We are taking this action
to allow interested persons additional time to submit comments and to
allow for public discussion at the February 25-26, 2014, Cellular,
Tissue, and Gene Therapies Advisory Committee meeting, where FDA will
present the draft guidance document for review.
DATES: FDA is extending the comment period on the draft guidance.
Submit either electronic or written comments by May 9, 2014.
ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to the
Office of Communication, Outreach and Development (HFM-40), Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist the office in processing your
request. The draft guidance may also be obtained by mail by calling
CBER at 1-800-835-
[[Page 69691]]
4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document
FOR FURTHER INFORMATION CONTACT: Melissa Reisman, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 2, 2013 (78 FR 39736), FDA
published a notice announcing the availability of a draft guidance
document entitled ``Guidance for Industry: Considerations for the
Design of Early-Phase Clinical Trials of Cellular and Gene Therapy
Products.'' The notice invited comments on the draft guidance by
November 22, 2013.
We are extending the comment period for the draft guidance to May
9, 2014. We are taking this action to allow interested persons
additional time to submit comments and to allow for public discussion
at the April 10-11, 2014, Cellular, Tissue, and Gene Therapies Advisory
Committee meeting, where FDA will present the draft guidance document
for review.
The Agency believes that this extension will not significantly
delay further FDA action on this guidance.
II. Request for Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
Dated: November 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27769 Filed 11-19-13; 8:45 am]
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