
[Federal Register: April 2, 2009 (Volume 74, Number 62)]
[Notices]               
[Page 14992]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ap09-60]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0132]

 
Draft Guidance for Industry: Somatic Cell Therapy for Cardiac 
Disease; 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 document entitled ``Guidance for Industry: 
Somatic Cell Therapy for Cardiac Disease'' dated March 2009. The draft 
guidance document provides sponsors of cellular therapies for the 
treatment of cardiac disease with recommendations on the design of 
preclinical and clinical studies, and information that should be 
submitted about the product delivery system. This guidance also 
provides recommendations on the chemistry, manufacturing and controls 
information to include in an investigational new drug application (IND) 
for cardiac cellular therapy.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115 (g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by July 1, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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, suite 200N, 
Rockville, MD 20852-1448; or the Division of Small Manufacturers, 
International, and Consumer Assistance (DSMICA), Center for Devices and 
Radiological Health (CDRH), Food and Drug Administration, 1350 Piccard 
Dr., Rockville, MD 20850. Send one self-addressed adhesive label to 
assist the office in processing your requests. The draft guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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 electronic comments 
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:
    Brenda R. Friend, Center for Biologics Evaluation and Research 
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448, 301-827-6210; or
    Sabina Reilly, Center for Devices and Radiological Health (HFZ-
450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 
20850, 240-276-4095.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Somatic Cell Therapy for Cardiac Disease'' 
dated March 2009. This guidance provides to sponsors developing 
cellular therapies for the treatment of cardiac disease with 
recommendations including, but not limited to, the following: (1) 
Design of preclinical and clinical studies; (2) information to submit 
on the product delivery system; and (3) the chemistry, manufacturing 
and controls information to include in an IND for cardiac cellular 
therapy. This guidance also includes regulatory considerations for the 
use of intravascular catheter delivery systems.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent FDA's current thinking on this topic. 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 requirement of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in the IND regulations (21 CFR part 312) 
have been approved under OMB control number 0910-0014, and the Good 
Laboratory Practice regulations (21 CFR part 58) have been approved 
under OMB control number 0910-0119.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding the draft guidance. Submit a 
single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in the brackets in 
the heading of this document. A copy of the draft guidance and received 
comments are available for public examination in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/cber/guidelines.htm or http://
www.regulations.gov.

    Dated: March 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7350 Filed 4-1-09; 8:45 am]

BILLING CODE 4160-01-S
