Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices 50215 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Section of the Federal Food, Drug, 

and Cosmetic Act 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

520(m)(6)(A)(ii) 3 1 3 50 150 

520(m)(6)(A)(iii) 1 1 1 100 100 

520(m)(6)(C) 5 1 5 100 500 

Total 1,250 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA based these estimates on the 

number of original HDE applications 

that the Center for Devices and 

Radiological Health (CDRH) received in 

the period between October 1, 2004, and 

September 30, 2007. During that time, 

CDRH received 16 original HDE 

applications or about 5 per year. 

FDA estimates that for each year, 

CDRH will receive five HDE 

applications and that three of these 

applications will be indicated for 

pediatric use. One HDE holder will 

notify the agency that the number of 

devices distributed in the year has 

exceeded the ADN and five HDE holders 

will petition to have the ADN modified 

due to additional information on the 

number of individuals affected by the 

disease of condition. 

The draft guidance refers also to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 803 have been approved under 

OMB control number 0910–0437; the 

collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078; the 

collections of information in 21 CFR 

part 807, subpart E have been approved 

under OMB control number 0910–0120; 

the collections of information in part 

814, subparts A, B, and C have been 

approved under OMB control number 

0910–0231; the collection of 

information in 21 CFR parts 50 and 56 

have been approved under OMB control 

number 0910–0130; the collections of 

information in 21 CFR part 820 have 

been approved under OMB control 

number 0910–0073; the collections of 

information in part 814, subpart H have 

been approved under OMB control 

number 0910–0332; and the collection 

of information requirements in 21 CFR 

10.30 have been approved under OMB 

control number 0910–0183. 

Dated: September 23, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23521 Filed 9–29–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Immortalized Transformed 

Lymphoblastoid Cell Lines From 

Patients with Franc ̧ois-Neetens 

Mouchete ́e Fleck Corneal Dystrophy 

(CFD) 

Description of Invention: Researchers 

at the National Eye Institute, NIH, have 

made available a set of immortalized 

transformed lymphoblastoid cell lines 

created from human T-lymphocytes 

obtained from patients with Franc ̧oisNeetens Mouchete ́e Fleck Corneal 

Dystrophy (CFD). The cells were 

transformed with defective Epstein-Barr 

virus using established methods. 

CFD is a rare, autosomal dominant 

corneal dystrophy characterized by 

numerous small white flecks scattered 

in all layers of the stroma. CFD has been 

associated with mutations in the PIP5K3 

protein, which is important for postGolgi vesicle processing. 

Applications: 

• Useful in the study of proteins 

expressed by lymphocytes, including in 

some cases the protein encoded by the 

mutant gene KCNJ13. 

• Useful as a renewable source of 

DNA for genetic studies related to CFD 

or the PIP5K3 protein. 

Inventors: J. Fielding Hejtmancik and 

Xiaodong Jiao (NEI). 

Relevant Publications: 

1. S Li et al. Mutations in PIP5K3 are 

associated with Franc ̧ois-Neetens 

mouchete ́e fleck corneal dystrophy. Am 

J Hum Genet. 2005 Jul;77(1):54–63. 

2. X Jiao et al. Genetic linkage of 

Francois-Neetens fleck (mouchete ́e) 

corneal dystrophy to chromosome 2q35. 

Hum Genet. 2003 May; 112(5–6):593– 

599. 

Patent Status: HHS Reference No. E– 

270–2009/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

licensing under a biological material 

license. 

Licensing Contact: Patrick P. McCue, 

PhD; 301–435–5560; 

mccuepat@mail.nih.gov. 

Novel Chemoattractant-Based Toxins to 

Improve Vaccine Immune Responses 

for Cancer and Infectious Diseases 

Description of Invention: Cancer is 

one of the leading causes of death in 

United States and it is estimated that 

there will be more than half a million 

deaths caused by cancer in 2009. A 

major drawback of the current 

chemotherapy-based therapeutics is the 

cytotoxic side-effects associated with 

them. Thus there is a dire need to 

develop new therapeutic strategies with 

fewer side-effects. Immunotherapy has 

taken a lead among the new therapeutic 

approaches. Enhancing the innate 

immune response of an individual has 

been a key approach for the treatment 

against different diseases such as cancer 

and infectious diseases. 


CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
50216 Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices 

This technology involves the 

generation of novel chemoattractant 

toxins that deplete the T regulatory cells 

(Treg) or other immunosuppressive or 

hyperactivated cells locally. Treg 

controls activation of immune responses 

by suppressing the induction of 

adaptive immune responses, 

particularly T cell responses. 

Immunosuppressive cells such as tumor 

infiltrating macrophages, regulatory T 

cells, regulatory B cells, or NKT and 

other cells down regulate antitumor 

immune responses. The chemoattractant 

toxins consist of a toxin moiety fused 

with a chemokine receptor ligand, such 

as chemokines and various 

chemoattractants, that enables specific 

targeting and delivery to the regulatory 

cells. This technology is advantageous 

over the more harmful antibodies and 

chemicals that are currently used for the 

systemic depletion of regulatory cells. 

The current technology can be used 

therapeutically in a variety of ways. 

They can be used together with vaccines 

to increase efficacy of the vaccine for 

the treatment of cancer, and can be used 

to locally deplete Treg, Bregs, or other 

immunosuppressive cells to induce 

cytolytic cell responses at the tumor site 

or to eliminate chronic infectious 

diseases such as HIV and tuberculosis. 

Applications: 

• New chemoattractant based toxins 

targeted towards Treg cells. 

• New chemoattractant based toxins 

targeted towards immunosuppressive B 

cells, NKT and macrophages. 

• New chemoattractant based toxins 

targeted towards local depletion of 

hyperactivated CD4 T cells to treat 

autoimmune diseases. 

• Chemoattractant based toxins 

depleting Treg cells or other 

immunosuppressive cells causing 

enhanced vaccine immune responses. 

• Novel immunotherapy by 

increasing vaccine efficacy against 

cancer and infectious diseases. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Market: 

• The technology platform involving 

novel chemo-attractant based toxins can 

be used to improve vaccine immune 

responses. 

• The technology platform has an 

additional market in treating several 

other clinical problems such as 

autoimmune diseases. 

Inventors: Arya Biragyn (NIA), Dolgor 

Bataar (NIA), et al. 

Related Publications: 

1. D Baatar, P Olkhanud, D Newton, 

K Sumitomo, A Biragyn. CCR4- 

expressing T cell tumors can be 

specifically controlled via delivery of 

toxins to chemokine receptors. J 

Immunol. 2007 Aug 1;179(3):1996– 

2004. 

2. D Baatar, P Olkhanud, K Sumitomo, 

D Taub, R Gress, A Biragyn. Human 

peripheral blood T regulatory cells 

(Tregs), functionally primed CCR4+ 

Tregs and unprimed CCR4- Tregs, 

regulate effector T cells using FasL. J 

Immunol. 2007 Apr 15;178(8):4891–900. 

3. M Coscia, A Biragyn. Cancer 

immunotherapy with chemoattractant 

peptides. Semin Cancer Biol. 2004 Jun; 

14(3):209–218. 

4. R Schiavo et al. Chemokine 

receptor targeting efficiently directs 

antigens to MHC class I pathways and 

elicits antigen-specific CD8+ T-cell 

responses. Blood 2006 Jun 15; 

107(12):4597–4605. 

Patent Status: U.S. Patent Application 

No. 11/992,880 filed 28 Mar 2008 (HHS 

Reference No. E–027–2005/0–US–06) 

Licensing Status: Available for 

licensing. 

Licensing Contact: Patrick P. McCue, 

PhD; 301–435–5560; 

mccuepat@mail.nih.gov. 

Collaborative Research Opportunity: 

The Immunotherapeutics Unit, National 

Institute on Aging, is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize Chemotoxin technology 

for clinical use or as a laboratory tool for 

depletion of cells. Please contact Nicole 

Darack, PhD at 301–435–3101 or 

darackn@mail.nih.gov for more 

information. 

Novel Agents Exhibiting Cytotoxicity 

Against Human Tumor Cell Lines 

Description of Invention: Researchers 

at the National Cancer Institute have 

developed novel agents that inhibit the 

growth of several human tumor cell 

lines. The new compounds are phenyl 

maleimides, some of which show 

cytotoxicity against human liver cancer 

cells in vitro in the low micromolar 

range. 

Applications: 

• Therapeutics for treating a broad 

range of cancers. 

• Use as pharmacologic probes for 

specific biochemical pathways. 

Advantages: 

• Demonstrated selective inhibition 

for cancer cells vs. untransformed cells 

in vitro and in vivo. 

• Potent growth inhibition of several 

human tumor cell lines. 

Development Status: Pre-clinical stage 

of development. 

Market: Cancer therapeutics. 

Inventors: Christophr J. Michejda and 

Wei Yao (NCI) et al.; Terrence R. Burke 

Jr. (NCI). 

Relevant Publication: S Kar, M Wang, 

W Yao, CJ Michejda, BI Carr. PM–20, a 

novel inhibitor of Cdc25A, induces 

extracellular signal-regulated kinase 1/2 

phosphorylation and inhibits 

hepatocellular carcinoma growth in 

vitro and in vivo. Mol Cancer Ther. 

2006 Jun; 5(6):1511–1519. 

Patent Status: U.S. Patent No. 

7,504,430 issued 17 Mar 2009 (HHS 

Reference No. E–110–2004/0–US–06). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Patrick P. McCue, 

PhD; 301–435–5560; 

mccuepat@mail.nih.gov. 

Dated: September 21, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–23590 Filed 9–29–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; Notice of 

Closed Meeting 

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 meeting. 

The meeting 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: National Institute of 

Biomedical Imaging and Bioengineering 

Special Emphasis Panel. 

Date: November 19, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: John K. Hayes, PhD, 

Scientific Review Officer, 6707 Democracy 

Boulevard, Suite 959, Democracy Two, 

Bethesda, MD 20892, 301–451–3398, 

hayesj@mail.nih.gov. 


CPrice-Sewell on DSKGBLS3C1PROD with NOTICES