67988 Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices 

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availability of the draft guidance 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comments on the draft guidance and 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draft guidance dated March 2009.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/

GuidanceComplianceRegulatory

Information/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] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Biological Chemistry and 

Macromolecular Biophysics. 

Date: December 2–3, 2010. 

Time: 11 a.m. to 10 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact: Donald L. Schneider, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5160, 

MSC 7842, Bethesda, MD 20892, (301) 435– 

1727, schneidd@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: BST Member Conflict Review Panel. 

Date: December 2, 2010. 

Time: 1:15 p.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National of Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call.) 

Contact Person: Ping Fan, MD, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5154, 

MSC 7840, Bethesda, MD 20892, 301–408– 

9971, fanp@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Behavioral and Social 

Consequences of HIV/AIDS. 

Date: December 3, 2010. 

Time: 11 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call.) 

Contact Person: Jose H. Guerrier, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5218, 

MSC 7852, Bethesda, MD 20892, 301–435– 

1137, guerriej@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Chromatin 

Insulators. 

Date: December 7–8, 2010. 

Time: 8 a.m. to 9 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting.) 

Contact Person: Michael H. Chaitin, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5202, 

MSC 7850, Bethesda, MD 20892, (301) 435– 

0910, chaitinm@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: October 29, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–27915 Filed 11–3–10; 8:45 am] 

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