Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices 55809 

technology provides the methods of 

delivering nucleic acids to cells of 

specific regions, tissues and cell types of 

the central nervous system (CNS); as 

well as to cells of the lung, by using 

AAV5 vectors and particles. The 

specific brain cells that are targeted by 

AAV5 belong to both non-neuronal/glial 

cells and neuronal cells, such as 

cerebellar cells and ependymal cells. 

The specific lung cells targeted by 

AAV5 are the apical surfaces of the 

airway such as alveolar cells. 

The prospective exclusive license will 

be royalty bearing and will comply with 

the terms and conditions of 35 U.S.C. 

209 and 37 CFR 404.7. The prospective 

exclusive license may be granted unless 

within thirty (30) days from the date of 

this published notice, the NIH receives 

written evidence and argument that 

establishes that the grant of the license 

would not be consistent with the 

requirements of 35 U.S.C. 209 and 37 

CFR 404.7. 

Applications for a license in the field 

of use filed in response to this notice 

will be treated as objections to the grant 

of the contemplated exclusive license. 

Comments and objections submitted to 

this notice will not be made available 

for public inspection and, to the extent 

permitted by law, will not be released 

under the Freedom of Information Act, 

5 U.S.C. 552. 

Dated: September 7, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–22833 Filed 9–13–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: The Development of 

Immunotoxins/Targeted Toxins for the 

Treatment of Human Cancers 

AGENCY: National Institutes of Health, 

Public Health Service, DHHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209(c)(1) and 37 CFR 

404.7(a)(1)(i), that the National 

Institutes of Health, Department of 

Health and Human Services, is 

contemplating the grant of an exclusive 

patent license to practice the inventions 

embodied in U.S. Patent Application 

61/241,620 entitled ‘‘Development of an 

Immunotoxin in Which All B–Cell 

Epitopes Have Been Removed and 

Which Has High Cytotoxic Activity’’ 

[HHS Ref. E–269–2009/0–US–01], U.S. 

Patent Application 60/969,929 entitled 

‘‘Deletions in Domain II of Pseudomonas 

Exotoxin A That Reduce Non-Specific 

Toxicity’’ [HHS Ref. E–292–2007/0–US– 

01], U.S. Patent Application 60/703,798 

entitled ‘‘Mutated Pseudomonas 

Exotoxins with Reduced Antigenicity’’ 

[HHS Ref. E–262–2005/0–US–01], U.S. 

Patent Application 60/160,071 entitled 

‘‘Immunoconjugates Having High 

Binding Affinity’’ [HHS Ref. E–139– 

1999/0–US–01], U.S. Patent Application 

60/067,175 entitled ‘‘Antibodies, 

Including Fv Molecules, and 

Immunoconjugates Having High 

Binding Affinity for Mesothelin and 

Methods for Their Use’’ [HHS Ref. E– 

021–1998/0–US–01], U.S. Patent 

Application 60/010,166 entitled 

‘‘Molecular Cloning of Mesothelin, a 

Differentiation Antigen Present on 

Mesothelium, Mesotheliomas and 

Ovarian Cancers’’ [HHS Ref. E–002– 

1996/0–US–01], PCT Application PCT/ 

US97/00224 entitled ‘‘Mesothelin 

Antigen and Methods and Kits for 

Targeting It’’ [HHS Ref. E–002–1996/1– 

PCT–01], U.S. Patent 5,747,654 entitled 

‘‘Recombinant Disulfide-Stabilized 

Polypeptide Fragments Having Binding 

Specificity’’ [HHS Ref. E–163–1993/0– 

US–01], PCT application PCT/US96/ 

16327 entitled ‘‘Immunotoxin 

Containing A Disulfide-Stabilized 

Antibody Fragment’’ [HHS Ref. E–163– 

1993/2–PCT–01], U.S. Patent 

Application 07/596,291 entitled ‘‘A 

Monoclonal Antibody’’ [HHS reference 

E–195–1990/0–US–01], and all 

continuing applications and foreign 

counterparts, to Morphotek, Inc. The 

patent rights in these inventions have 

been assigned to and/or exclusively 

licensed to the Government of the 

United States of America. 

The prospective exclusive license 

territory may be worldwide, and the 

field of use may be limited to: 

The use of the MORAb-009–PE–LR/8X 

immunotoxin for the treatment of 

mesothelin-expressing cancers, the use of the 

anti-CD300LF–PE/LR/8X immunotoxin for 

the treatment of CD300LF-expressing cancers 

such as acute myelogenous leukemia (AML), 

and the use of annexin A2-targeted PE–LR/ 

8X toxin for the treatment of annexin A2- 

expressing cancers such as glioma, ovarian 

cancer and pancreatic cancer. 

DATES: Only written comments and/or 

applications for a license which are 

received by the NIH Office of 

Technology Transfer on or before 

October 14, 2010 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated exclusive license should 

be directed to: David A. Lambertson, 

PhD., Senior Licensing and Patenting 

Manager, Office of Technology Transfer, 

National Institutes of Health, 6011 

Executive Boulevard, Suite 325, 

Rockville, MD 20852–3804; Telephone: 

(301) 435–4632; Facsimile: (301) 402– 

0220; E-mail: lambertsond@od.nih.gov. 

SUPPLEMENTARY INFORMATION: These 

inventions concern immunotoxins and 

targeted toxins, and methods of using 

the immunotoxins/targeted toxins for 

the treatment of (a) mesothelinexpressing cancers (such as 

mesothelioma, ovarian cancer and 

pancreatic cancer), (b) CD300LFexpressing cancers (such as acute 

myelogenous leukemia (AML)) or (c) 

Annexin A2-expressing cancers (such as 

glioma, ovarian cancer and pancreatic 

cancer). Several specific immunotoxins/ 

targeted toxins are covered by this 

technology, including MORAb-009–PE– 

LR/8X, anti-CD300LF–PE–LR/8X and 

Annexin A2-targeted PE–LR/8X. 

Each of these immunotoxins/targeted 

toxins comprises (1) a toxin moiety (PE– 

LR/8X) that is a modified version of the 

Pseudomonas exotoxin A (‘‘PE’’) and (2) 

either (a) an antibody fragment domain 

that is capable of binding to mesothelin, 

(b) an antibody fragment domain that is 

capable of binding to CD300LF, or (c) a 

peptide that is capable of binding to 

Annexin A2. The toxin moiety been 

modified in various manners in order 

reduce immunogenicity, thereby 

improving the therapeutic value of PE 

while maintaining its ability to trigger 

cell death. Since mesothelin, CD300LF 

and Annexin A2 are each preferentially 

expressed on certain types of cancer 

cells, the targeting domains of the 

immunotoxins/targeted toxins (MORAb009, anti-CD300LF and Annexin A2 

binding peptide) allows the 

immunotoxins/targeted toxins to 

selectively bind to certain cancer cells 

so that only the cancer cells are killed. 

This results in an effective therapeutic 

strategy with fewer side effects due to 

less non-specific killing of cells. 

The prospective exclusive license will 

be royalty bearing and will comply with 

the terms and conditions of 35 U.S.C. 

209 and 37 CFR 404.7. The prospective 

exclusive license may be granted unless 

the NIH receives written evidence and 

argument that establishes that the grant 

of the license would not be consistent 

with the requirements of 35 U.S.C. 209 

and 37 CFR 404.7 within thirty (30) 

days from the date of this published 

notice. 

Applications for a license in the field 

of use filed in response to this notice 

will be treated as objections to the grant 

of the contemplated exclusive license. 


jlentini on DSKJ8SOYB1PROD with NOTICES
55810 Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices 

Comments and objections submitted to 

this notice will not be made available 

for public inspection and, to the extent 

permitted by law, will not be released 

under the Freedom of Information Act, 

5 U.S.C. 552. 

Dated: September 7, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

& Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–22844 Filed 9–13–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0425] 

Withdrawal of Approval of New Animal 

Drug Applications; Chloramphenicol, 

Lincomycin, Pyrantel Tartrate, and 

Tylosin Phosphate and Sulfamethazine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of four new animal drug 

applications (NADAs). In a final rule 

published elsewhere in this issue of the 

Federal Register, FDA is amending the 

regulations to remove portions reflecting 

approval of these NADAs. 

DATES: Withdrawal of approval is 

effective September 24, 2010. 

FOR FURTHER INFORMATION CONTACT: John 

Bartkowiak, Center for Veterinary 

Medicine (HFV–212), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9079, 

email: john.bartkowiak@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: John J. 

Ferrante, 11 Fairway Lane, Trumbull, 

CT 06611; International Nutrition, Inc., 

7706 ‘‘I’’ Plaza, Omaha, NE 68127; and 

Feed Service Co., Inc., 303 Lundin 

Blvd., P.O. Box 698, Mankato, MN 

56001 have requested that FDA 

withdraw approval of the four NADAs 

listed in table 1 because they are no 

longer manufactured or marketed: 

TABLE 1. 

Sponsor NADA Number Product (Established Name of Drug) 21 CFR Cite (Sponsor’s Drug Labeler 

Code) 

John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611 NADA 65–137 AMPHICOL–V Capsules (chloramphenicol) § 520.390b (058034) 

International Nutrition, Inc., 7706 ‘‘I’’ Plaza, 

Omaha, NE 68127 

NADA 121–337 INI Swine Ban-Wormer B–9.6 BA. 

(pyrantel tartrate) 

§ 558.485 (043733) 

International Nutrition, Inc., 7706 ‘‘I’’ Plaza, 

Omaha, NE 68127 

NADA 132–923 LINCO 8/LINCO 20 (lincomycin) § 558.325 (043733) 

Feed Service Co., Inc., 303 Lundin Blvd., 

P.O. Box 698, Mankato, MN 56001 

NADA 138–342 TYLAN 5 Sulfa-G Premix (tylosin 

and sulfamethazine) 

§ 558.630 (030841) 

Therefore, under authority delegated 

to the Commissioner of Food and Drugs 

and redelegated to the Center for 

Veterinary Medicine, and in accordance 

with § 514.116 Notice of withdrawal of 

approval of application (21 CFR 

514.116), notice is given that approval 

of NADAs 65–137, 121–337, 132–923, 

and 138–342, and all supplements and 

amendments thereto, is hereby 

withdrawn, effective September 24, 

2010. 

In a final rule published elsewhere in 

this issue of the Federal Register, FDA 

is amending the animal drug regulations 

to reflect the withdrawal of approval of 

these NADAs. 

Dated: September 1, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–22809 Filed 9–13–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–3315– 

EM; Docket ID FEMA–2010–0002] 

Massachusetts; Emergency and 

Related Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This is a notice of the 

Presidential declaration of an 

emergency for the Commonwealth of 

Massachusetts (FEMA–3315–EM), dated 

September 2, 2010, and related 

determinations. 

DATES: Effective Date: September 2, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Miller, Recovery Directorate, 

Federal Emergency Management 

Agency, 500 C Street, SW., Washington, 

DC 20472, (202) 646–3886. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that, in a letter dated 

September 2, 2010, the President issued 

an emergency declaration under the 

authority of the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act, 42 U.S.C. 5121–5207 

(the Stafford Act), as follows: 

I have determined that the emergency 

conditions in certain areas of the 

Commonwealth of Massachusetts resulting 

from Hurricane Earl beginning on September 

1, 2010, and continuing, are of sufficient 

severity and magnitude to warrant an 

emergency declaration under the Robert T. 

Stafford Disaster Relief and Emergency 

Assistance Act, 42 U.S.C. 5121 et seq. (‘‘the 

Stafford Act’’). Therefore, I declare that such 

an emergency exists in the Commonwealth of 

Massachusetts. 

You are authorized to provide appropriate 

assistance for required emergency measures, 

authorized under Title V of the Stafford Act, 

to save lives and to protect property and 

public health and safety, and to lessen or 

avert the threat of a catastrophe in the 

designated areas. Specifically, you are 

authorized to provide assistance for 

emergency protective measures (Category B), 

including direct Federal assistance, under the 

Public Assistance program. This assistance 

excludes regular time costs for subgrantees’ 

regular employees. 

Consistent with the requirement that 

Federal assistance is supplemental, any 


jlentini on DSKJ8SOYB1PROD with NOTICES