14992 Federal Register / Vol. 74, No. 62 / Thursday, April 2, 2009 / Notices 

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Dated: March 27, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

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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Draft Guidance for Industry: Somatic 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. 

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 The draft guidance 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draft guidance by July 1, 2009.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single copies of the draft guidance to the 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 selfaddressed 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draft guidance may also be obtained by 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electronic access to the draft guidance 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. 

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