Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices 67987 

• The worldwide incidence of new 

cancer patients is forecast to increase 

from 4.2 million cases in the major 

cancer markets in 2005 to 4.6 million in 

2010. 

• It is estimated that the worldwide 

cancer marker will be worth 85.3 billion 

in 2010. 

Inventors: Donald P. Bottaro et al. 

(NCI). 

Relevant Publications 

1. Atabey N, Gao Y, Yao Z-J, 

Breckenridge D, Soon L, Soriano JV, 

Burke TR Jr, Bottaro DP. Potent 

blockade of Hepatocyte Growth 

Factor-stimulated cell motility, 

matrix invasion and branching 

morphogenesis by antagonists of 

Grb2 Src homology 2 domain 

interactions. J Biol Chem. 2001 Apr 

27;276(17):14308–14314. [PubMed: 

11278639]. 

2. Shi Z-D, Wei C-Q, Wang X, Lee K, Liu 

H, Zhang M, Vasselli J, Bottaro DP, 

Linehan WM, Yang D, Burke TR Jr. 

Macrocyclization in the design of 

tetra-tetrapeptide mimetics that 

display potent inhibition of Grb2 

SH2 domain binding in whole cell 

systems. In: Peptide Revolution: 

Genomics, Proteomics 

Therapeutics. Chorev, M and 

Sawyer, TK, Eds. American Peptide 

Society, pp 515–517, 2003. 

3. Soriano JV, Lui N, Gao Y, Yao Z-J, 

Ishibashi T, Underhill C, Burke TR 

Jr, Bottaro DP. Inhibition of 

angiogenesis by growth factor 

receptor bound protein 2-Src 

homology 2 domain bound 

antagonists. Mol Cancer Ther. 2004 

Oct;3(10):1289–1299. [PubMed: 

15486196]. 

4. Shi Z-D, Karki RG, Worthy KM, 

Bindu LK, Dharmawardana PG, 

Nicklaus MC, Bottaro DP, Fisher RJ, 

Burke TR Jr. Utilization of a 

nitrobenzoxadiazole (NBD) 

fluorophore in the design of a Grb2 

SH2 domain-binding peptide 

mimetic. Bioorg Med Chem Lett. 

2005 Mar 1;15(5):1385–1388. 

[PubMed: 15713392]. 

5. Kang S-U, Shi, Z-D, Worthy KM, 

Bindu LK, Dharmawardana PG, 

Choyke SJ, Bottaro DP, Fisher RJ, 

Burke TR Jr. Examination of 

phosphoryl-mimicking 

functionalities within a macrocyclic 

Grb2 SH2 domain-binding platform. 

J Med Chem. 2005 Jun 

16;48(12):3945–3948. [PubMed: 

15943469]. 

6. Shi Z-D, Peruzzi B, Dharmawardana 

PG, Leech T, Appella E, Worthy 

KM, Bindu LK, Fisher RJ, Bottaro 

DP, Burke TR Jr. Synthesis and use 

of C-terminally biotinylated 

peptidomimetics with high Grb2 

SH2 domain-binding affinity. In: 

Understanding Biology Using 

Peptides, Blondelle SE (Ed), 

American Peptide Society, pp 208– 

209, 2005. 

7. Dharmawardana PG, Peruzzi B, 

Giubellino A, Burke TR Jr, Bottaro 

DP. Molecular targeting of growth 

factor receptor-bound 2 (Grb-2) as 

an anti-cancer strategy. Anti-Cancer 

Drugs 2006 Jan;17(1):13–20. 

[PubMed: 16317285]. 

8. Liu F, Worthy KM, Bindu L, 

Giubellino A, Bottaro DP, Fisher RJ, 

Burke TR Jr. Utilization of achiral 

alkenyl amines for the preparation 

of high affinity Grb2 SH2 domainbinding macrocycles by ring-closing 

metathesis. Org Biomol Chem. 2007 

Jan 21;5(2):367–372. [PubMed: 

17205182]. 

9. Giubellino A, Gao Y, Lee S, Lee MJ, Vasselli JR, Medepalli S, Trepel 

JB, Burke TR Jr, Bottaro DP. 

Inhibition of tumor metastasis by a 

growth factor receptor bound 

protein Src domain-binding 

antagonist. Cancer Res. (Priority 

Report) 2007 Jul 1;67(13):6012– 

6016. [PubMed: 17616655]. 

Patent Status: U.S. Patent Application 

No. 11/525,672 filed 22 Sep 2006 (HHS 

Reference No. E–265–1999/2–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jennifer Wong; 

301–435–4633; wongje@mail.nih.gov. 

Collaborative Research Opportunity: 

The Urologic Oncology Branch of the 

National Cancer Institute is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize Grb2 SH2 domain 

antagonists as anti-cancer drugs. Please 

contact John D. Hewes, Ph.D. at 301– 

435–3121 or hewesj@mail.nih.gov for 

more information. 

Dated: October 29, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–27912 Filed 11–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES
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] 

BILLING CODE 4160–01–P 

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] 

BILLING CODE 4140–01–P 


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