[Federal Register Volume 75, Number 213 (Thursday, November 4, 2010)]
[Notices]
[Pages 67987-67988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27881]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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draft guidance entitled ``Guidance for Industry: Somatic Cell Therapy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