Document ID: FDA-2009-D-0132-0011
Agency: fda
Document Type: Notice
Title: Guidance for Industry; Availability: Cellular Therapy for Cardiac Disease
Posted Date: 2010-11-04T04:00Z

[Federal Register: November 4, 2010 (Volume 75, Number 213)]
[Notices]               
[Page 67987-67988]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no10-54]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Guidance for Industry: Cellular 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 document entitled ``Guidance for Industry: Cellular 
Therapy for Cardiac Disease'' dated October 2010. The guidance document 
provides sponsors who are developing cellular therapies for the 
treatment of cardiac disease with recommendations on the design of 
preclinical and clinical studies and on the chemistry, manufacturing 
and controls (CMC) information that should be included in an 
investigational new drug application (IND) for cellular therapy for 
cardiac disease. The guidance announced in this notice finalizes the 
draft guidance entitled ``Guidance for Industry: Somatic Cell Therapy 
for Cardiac Disease'' dated March 2009.

DATES: Submit either electronic or written comments on agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the 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; or to the Division of Small Manufacturers, International, and 
Consumer Assistance, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist the office in processing your requests. The 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 
guidance document.
    Submit electronic comments on the guidance to http://
www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Benjamin A. Chacko, Center for

[[Page 67988]]

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 document entitled 
``Guidance for Industry: Cellular Therapy for Cardiac Disease,'' dated 
October 2010. This guidance document provides sponsors who are 
developing cellular therapies for the treatment of cardiac disease with 
recommendations regarding the: (1) Design of preclinical and clinical 
studies, (2) CMC information that should be included in an IND for 
cardiac cellular therapy, and (3) information about the product's 
delivery system that should be submitted. This guidance also includes a 
discussion of regulatory considerations regarding cellular delivery 
systems.
    In the Federal Register of April 2, 2009 (74 FR 14992), FDA 
announced the availability of the draft guidance entitled ``Guidance 
for Industry: Somatic Cell Therapy for Cardiac Disease'' dated March 
2009. FDA received several comments on the draft guidance and those 
comments were considered as the guidance was finalized. In addition, 
additional changes were made to improve the document. The guidance 
announced in this notice finalizes the draft guidance dated March 2009.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 
requirements 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, the good 
laboratory practice regulations (21 CFR part 58) have been approved 
under OMB control number 0910-0119, the investigational device 
exemption (IDE) regulations (21 CFR part 812) have been approved under 
OMB control number 0910-0078, and the informed consent regulations (21 
CFR part 50) have been approved under OMB control number 0910-0130.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/default.htm, or http://www.regulations.gov.

    Dated: October 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-27881 Filed 11-3-10; 8:45 am]
BILLING CODE 4160-01-P