2010-27881. Guidance for Industry: Cellular 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 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 The guidance announced in this notice finalizes the draft guidance entitled “Guidance for Industry: Somatic Cell Therapy for Cardiac Disease” dated March 2009.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 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.