Document ID: FDA-2013-D-0576-0003
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry:  Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Extension of Comment Period
Posted Date: 2013-11-20T05:00Z

[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69690-69691]
From the Federal Register Online via the Government Printing 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Draft Guidance for Industry: Considerations for the Design of 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comment period for the draft guidance for industry entitled ``Guidance 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 The draft guidance 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we requested comments on the draft guidance.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present the draft guidance document for review.

DATES: FDA is extending the comment period on the draft guidance.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ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 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Submit written requests for single copies of the draft guidance to the 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]
BILLING CODE 4160-01-P