45866 Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 

520(g) of the act for human tests to begin 

became effective April 11, 1997. 

2. The date an application was 

initially submitted with respect to the 

device under section 515 of the act (21 

U.S.C. 360e): October 18, 2007. FDA has 

verified the applicant’s claim that the 

premarket approval application (PMA) 

for TALENT ABDOMINAL STENT 

GRAFT SYSTEM (PMA P070027) was 

initially submitted October 18, 2007. 

3. The date the application was 

approved: April 15, 2008. FDA has 

verified the applicant’s claim that PMA 

P070027 was approved on April 15, 

2008. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,183 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by November 3, 2009. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

March 3, 2010. To meet its burden, the 

petition must contain sufficient facts to 

merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. 

Comments and petitions may be seen 

in the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: June 8, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–21424 Filed 9–3–09; 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. 

Antigenic Chimeric Tick-Borne 

Encephalitis Virus/Dengue Virus Type 4 

Recombinant Viruses 

Description of Technology: The tickborne encephalitis virus (TBEV) 

complex is a group of viruses that can 

cause severe neutrotropic disease and 

up to thirty percent (30%) mortality. 

While these viruses can be found in 

many parts of the world, the largest 

impact of the disease occurs in Europe 

and Russia, where approximately 

fourteen thousand (14,000) hospitalized 

TBEV cases occur annually. TBEV is in 

the family Flaviviridae, genus flavivirus 

and is composed of a positive-sense 

single stranded RNA genome that 

contains 5′ and 3′ non-coding regions 

and a single open reading frame 

encoding ten (10) proteins. At present, 

a vaccine or FDA approved antiviral 

therapy is not available. 

The inventors have previously 

developed a WNV/Dengue4Delta30 

antigenic chimeric virus as a live 

attenuated virus vaccine candidate that 

contains the WNV premembrane and 

envelope (prM and E) proteins on a 

dengue virus type 4 (DEN4) genetic 

background with a thirty nucleotide 

deletion (Delta30) in the DEN4 3′-UTR. 

Using a similar strategy, the inventors 

have generated an antigenic chimeric 

virus, TBEV/DEN4Delta30. This 

chimeric virus also contains attenuating 

mutations within the E and 

nonstructural NS5 proteins. Preclinical 

testing results with the derived virus 

indicate that chimerization of TBEV 

with DEN4Delta30 and introduction of 

the attenuating mutations decreased 

neuroinvasiveness and neurovirulence 

in mice. The TBEV/DEN4delta30 

vaccine candidate was safe, 

immunogenic, and provided protection 

in monkeys against challenge with TBE 

viruses. 

This application claims live 

attenuated chimeric TBEV/DEN4Delta30 

vaccine compositions. Also claimed are 

methods of treating or preventing TBEV 

infection in a mammalian host, methods 

of producing a subunit vaccine 

composition, isolated polynucleotides 

comprising a nucleotide sequence 

encoding a TBEV immunogen, methods 

for detecting TBEV infection in a 

biological sample and infectious 

chimeric TBEV. 

Applications: Development of TickBorne Encephalitis Virus vaccines, 

therapeutics and diagnostics. 

Advantages: Live attenuated chimeric 

vaccine, known regulatory pathway, 

potential for lasting immunity with 

fewer doses. 

Development Status: Vaccine 

candidates have been synthesized and 

preclinical studies have been 

performed. 

Inventors: Alexander G. Pletnev, 

Amber R. Engel, Brian R. Murphy 

(NIAID). 

Patent Status: U.S. Provisional 

Application No. 61/181,982 filed 28 

May 2009 (HHS Reference No. E–078– 

2009/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301–435–4646; 

soukasp@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIAID is seeking statements of 

capability or interest from parties 

interested in collaborative research in 

preclinical study of the long-term 

immunity induced by the TBEV/DEN4 

vaccine candidate against highly 

virulent TBE viruses and in the clinical 

trials of this vaccine in humans. Please 

contact Michael Piziali, NIAID Office of 

Technology Development, at 301–496– 

2644 for more information. 

Monoclonal Antibodies That React 

With the Capsule of Bacillus 

anthracis 

Description of Technology: Bacillus 

anthracis is the causative agent of 

anthrax and is surrounded by a 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 45867 

polypeptide capsule of poly-g-Dglutamic acid (gDPGA). gDPGA is poorly 

immunogenic and has antiphagocytic 

properties. The bacterial capsule is 

essential for virulence. Antibodies to the 

capsule have been shown to enhance 

phagocytosis and killing of 

encapsulated bacilli. These antibodies 

in combination with antibodies that 

neutralize the toxins of B. anthracis 

could provide enhanced protection by 

their dual antibacterial and antitoxic 

activities. Such antibodies would be 

especially useful for antibiotic-resistant 

strains. 

In order to obtain therapeutically 

useful anti-g DPGA monoclonal 

antibodies (MAbs), the inventors 

immunized chimpanzees with 

conjugates of 15-mer glutamic acid 

polymers to immunogenic protein 

carriers (recombinant protective antigen 

(PA) of B. anthracis). After several 

immunizations, chimpanzees developed 

strong immune responses to gDPGA. A 

combinatorial Fab library of mRNA 

derived from the chimpanzee’s bone 

marrow was prepared and eight (8) 

distinct Fabs reactive with native 

gDPGA were recovered. Two (2) of the 

Fabs were converted into full-length IgG 

with human g1 heavy chain constant 

regions. These two (2) MAbs showed 

strong opsonophagocytic killing of 

bacilli in an in vitro assay. These two (2) 

MAbs were also tested for protection of 

mice challenged with virulent anthrax 

spores and results showed that both 

MAbs provided full or nearly full 

protection at a dose of 0.3 mg, the 

lowest dose tested, which is much more 

potent than previously reported murine 

anti-PGA MAbs. Since chimpanzee 

immunoglobulins are virtually identical 

to human immunoglobulins, these 

chimpanzee anticapsule MAbs may 

have clinically useful applications. 

This application claims the antibody 

compositions described above. Also 

claimed are methods of treating or 

preventing B. anthracis infection in a 

mammalian host and isolated 

polynucleotides comprising a 

nucleotide sequence encoding the 

antibodies of the technology. 

Applications: Development of anthrax 

vaccines, therapeutics and diagnostics. 

Advantages: Strongly neutralizing 

antibodies, known regulatory pathway, 

potential for use as both a prophylaxis 

and therapy. 

Development Status: Preclinical 

studies have been performed utilizing 

the monoclonal antibodies of this 

technology. 

Inventors: Zhaochun Chen (NIAID), 

Robert H. Purcell (NIAID), Joanna 

Kubler-Kielb (NICHD), Lily Zhongdong 

Dai (NICHD), Rachel Schneerson 

(NICHD). 

Patent Status: U.S. Provisional 

Application No. 61/116,222 filed 19 

Nov 2008 (HHS Reference No. E–125– 

2008/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301–435–4646; 

soukasp@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIAID is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize MAbs neutralizing 

anthrax toxins and capsule for 

comprehensive protection against 

anthrax. Please contact Bill Ronnenberg, 

NIAID Office of Technology 

Development, at 301–451–3522 for more 

information. 

Dated: August 28, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–21482 Filed 9–3–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Health 

Promotion and Disease Prevention 

Research Centers, Special Interest 

Project Competitive Supplements 

(SIPS) (U48 Panels A–M), RFA–DP09– 

101SUPP09, Initial Review 

Cancellation: The notice was 

originally published in the Federal 

Register on July 14, 2009 (Volume 74, 

Number 133) [page 34026]. The 

following panels are cancelled: D, F, K, 

L and M. 

Contact Person for More Information: 

Brenda Colley-Gilbert, PhD, Director, 

Extramural Research Program Office, 

CCCH, 4770 Buford Highway, MS K–92, 

Atlanta, GA 30341, Telephone (770) 

488–6295. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Dated: August 26, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–21379 Filed 9–3–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0233] 

Report on the Performance of Drug 

and Biologics Firms in Conducting 

Postmarketing Requirements and 

Commitments; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: Under the Food and Drug 

Administration Modernization Act of 

1997 (Modernization Act), the Food and 

Drug Administration (FDA) is required 

to report annually in the Federal 

Register on the status of postmarketing 

requirements and commitments 

required of, or agreed upon, by holders 

of approved drug and biological 

products. This is the agency’s report on 

the status of the studies and clinical 

trials that applicants have agreed to or 

are required to conduct. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn C. Lee, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6464, 

Silver Spring, MD 20993–0002, 

301–796–0700; or 

Robert Yetter, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 

1400 Rockville Pike, Rockville, MD 

20852, 301–827–0373. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. The Modernization Act 

Section 130(a) of the Modernization 

Act (Public Law 105–115) amended the 

Federal Food, Drug, and Cosmetic Act 

(the act) by adding a new provision 

requiring reports of certain 

postmarketing studies, including 

clinical trials, for human drug and 

biological products (section 506B of the 

act (21 U.S.C. 356(b)). Section 506B of 

the act provides FDA with additional 

authority to monitor the progress of a 

postmarketing study or clinical trial that 

an applicant has been required to or has 

agreed to conduct by requiring the 

applicant to submit a report annually 


srobinson on DSKHWCL6B1PROD with NOTICES