Federal Register / Vol. 73, No. 188 / Friday, September 26, 2008 / Notices 55853 

Cosmetic Act (the act) (21 U.S.C. 

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the act. 

The 30-day period for requesting 

reconsideration of an FDA action under 

§ 10.33(b) (21 CFR 10.33(b)) for notices 

announcing approval of a PMA begins 

on the day the notice is placed on the 

Internet. Section 10.33(b) provides that 

FDA may, for good cause, extend this 

30-day period. Reconsideration of a 

denial or withdrawal of approval of a 

PMA may be sought only by the 

applicant; in these cases, the 30-day 

period will begin when the applicant is 

notified by FDA in writing of its 

decision. 

The regulations provide that FDA 

publish a quarterly list of available 

safety and effectiveness summaries of 

PMA approvals and denials that were 

announced during that quarter. The 

following is a list of approved PMAs for 

which summaries of safety and 

effectiveness were placed on the 

Internet from April 1, 2008, through 

June 30, 2008. There were no denial 

actions during this period. The list 

provides the manufacturer’s name, the 

product’s generic name or the trade 

name, and the approval date. 

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM APRIL 1, 

2008, THROUGH JUNE 30, 2008 

PMA No./Docket No. Applicant TRADE NAME Approval Date 

P050020 

FDA–2008–M–0207 

Abbott Diabetes Care, Inc. FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE 

MONITORING SYSTEM 

March 12, 2008 

P010012 (S037) 

FDA–2008–M–0243 

Guidant Corp. Contak Renewal 3 AVT system & contak reviewal 3AVT 

HE System 

March 13, 2008 

P070027 

FDA–2008–M–0244 

Medtronic Vascular The talent abdominal stent graft system April 15, 2008 

P060040 

FDA–2008–M–0283 

Thoratec Corp. Thoratec Heartmate II Left ventricular assist April 21, 2008 

P070008 

FDA–2008–M–0335 

Biotronik, Inc. Stratos LV CRT–P & stratos LV–T CRT–P, corox OTW 

BP lead & corox OTW-s bp lead 

May 12, 2008 

P070016 

FDA–2008–M–0311 

Cook, Inc. Zenith TX2 Thoracic TAA endovascular graft with the 

H&LB One-shot introduction system 

May 21, 2008 

P070007 

FDA–2008–M–0342 

Medtronic Vascular Talent Thoracic Stent Graft System June 5, 2008 

H070003 

FDA–2008–M–0378 

Synapse Biomedical, Inc. NeuRx RA/4 June 17, 2008 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cdrh/pmapage.html. 

Dated: September 12, 2008. 

Daniel G. Schultz, 

Director, Center for Devices and Radiological 

Health. 

[FR Doc. E8–22668 Filed 9–25–08; 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. 

Methods for Preparing Bacillus 

anthracis Protective Antigen for Use 

in Vaccines 

Description of Technology: This 

invention relates to improved methods 

of preparing Bacillus anthracis 

protective antigen (PA) from a cell or 

organism, particularly a recombinant 

cell or microorganism, for use in 

vaccines. Production and purification 

methods of modified PA from a nonsporogenic strain of Bacillus anthracis 

are described. Specifically, a scalable 

fermentation and purification process is 

claimed that is suitable for vaccine 

development, and that produces almost 

three times more product than earlierreported processes. This is 

accomplished using a biologically 

inactive protease-resistant PA variant in 

a protease-deficient non-sporogenic 

avirulent strain of B. anthracis (BH445). 

One of the PA variants described in the 

patent application lacks the furin and 

chymotrypsin cleavage sites. 

Advantages: Bacillus anthracis 

protective antigen is a major component 

of the currently licensed human vaccine 

(Anthrax Vaccine Adsorbed, AVA). 

Although the current human vaccine 

has been shown to be effective against 

cutaneous anthrax infection in animals 

and humans and against inhalation 

anthrax in rhesus monkeys, the licensed 

vaccine has several limitations: (1) AVA 


jlentini on PROD1PC65 with NOTICES
55854 Federal Register / Vol. 73, No. 188 / Friday, September 26, 2008 / Notices 

elicits a relatively high degree of local 

and systemic adverse reactions, 

probably mediated by variable amounts 

of undefined bacterial products, making 

standardization difficult; (2) the 

immunization schedule requires 

administration of six doses within an 

eighteen (18) month period, followed by 

annual boosters; (3) there is no defined 

vaccine-induced protective level of 

antibody to PA by which to evaluate 

new lots of vaccines; and (4) AVA is 

comprised of a wild-type PA. Thus a 

vaccine comprising a modified purified 

recombinant PA would be effective, 

safe, allow precise standardization, and 

require fewer injections. 

The invention also relates to PA 

variants, and/or compositions thereof, 

which are useful for eliciting an 

immunogenic response in mammals, 

particularly humans, including 

responses that provide protection 

against, or reduce the severity of, 

infections caused by B. anthracis. The 

vaccines claimed in this application are 

intended for active immunization for 

prevention of B. anthracis infection, and 

for preparation of immune antibodies. 

Application: Improved B. anthracis 

vaccines. 

Development Status: Phase I clinical 

studies are being performed. 

Inventors: Joseph Shiloach (NIDDK), 

Stephen Leppla (NIDCR), Delia Ramirez 

(NIDDK), Rachel Schneerson (NICHD), 

John Robbins (NICHD). 

Publication: DM Ramirez et al. 

Production, recovery and 

immunogenicity of the protective 

antigen from a recombinant strain of 

Bacillus anthracis. J Ind Microbiol 

Biotechnol. 2002 Apr;28(4):232–238. 

Patent Status: U.S. Patent Application 

No. 10/290,712 filed 08 Nov 2002 (HHS 

Reference No. E–023–2002/0–US–02) 

Licensing Status: Available for 

exclusive or nonexclusive licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institutes of Health is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize 

methods of preparing Bacillus anthracis 

protective antigen (PA) from a cell or 

organism, particularly a recombinant 

cell or microorganism, for use in 

vaccines. Please contact Rochelle S. 

Blaustein, J.D., at 301/451–3636 or 

Rochelle.Blaustein@nih.gov for 

additional information. 

Recombinant Modified Bacillus 

anthracis Protective Antigen for Use 

in Vaccines 

Description of Technology: This 

invention relates to improved methods 

of preparing Bacillus anthracis 

protective antigen (PA) for use in 

vaccines. PA is a secreted, non-toxic 

protein with a molecular weight of 83 

KDa. PA is a major component of the 

currently licensed human vaccine 

(Anthrax Vaccine Adsorbed, AVA). 

Although the licensed human vaccine 

has been shown to be effective against 

cutaneous anthrax infection in animals 

and humans and against inhalation 

anthrax in rhesus monkeys, the licensed 

vaccine has several limitations: (1) AVA 

elicits a relatively high degree of local 

and systemic adverse reactions, 

probably mediated by variable amounts 

of undefined bacterial products, making 

standardization difficult; (2) the 

immunization schedule requires 

administration of six doses within an 

eighteen (18) month period, followed by 

annual boosters; (3) there is no defined 

vaccine-induced protective level of 

antibody to PA by which to evaluate 

new lots of vaccines; and (4) AVA is 

comprised of a wild-type PA. It has been 

suggested that a vaccine comprising a 

modified purified recombinant PA 

would be effective, safe, allow precise 

standardization, and require fewer 

injections. 

This invention claims methods of 

producing and recovering PA from a cell 

or organism, particularly a recombinant 

cell or microorganism. The invention 

claims production and purification of 

modified PA from a non-sporogenic 

strain of Bacillus anthracis. In contrast 

to other previously described methods, 

greater quantities of PA are obtainable 

from these cells or microorganisms. 

Specifically, a scalable fermentation and 

purification process is claimed that is 

suitable for vaccine development, and 

that produces almost three times more 

product than earlier-reported processes. 

This is accomplished using a 

biologically inactive protease-resistant 

PA variant in a protease-deficient nonsporogenic avirulent strain of B. 

anthracis (BH445). One of the PA 

variants described in the patent 

application lacks the furin and 

chymotrypsin cleavage sites. 

The invention relates to improved 

methods of producing and recovering 

sporulation-deficient B. anthracis 

mutant stains, and for producing and 

recovering recombinant B. anthracis 

protective antigen (PA), especially 

modified PA which is protease resistant, 

and to methods of using of these PAs or 

nucleic acids encoding these PAs for 

eliciting an immunogenic response in 

humans, including responses which 

provide protection against, or reduce the 

severity of, B. anthracis bacterial 

infections and which are useful to 

prevent and/or treat illnesses caused by 

B. anthracis, such as inhalation anthrax, 

cutaneous anthrax and gastrointestinal 

anthrax. 

Application: Improved B. anthracis 

vaccines. 

Development Status: Phase I clinical 

studies are being performed. 

Inventors: Stephen Leppla (NIDCR), 

M. J. Rosovitz (NIDCR), John Robbins 

(NICHD), Rachel Schneerson (NICHD). 

Patent Status: U.S. Patent No. 

7,261,900 issued 28 Aug 2007 (HHS 

Reference No. E–268–2002/0–US–02); 

U.S. Patent Application No. 11/831,860 

filed 31 Jul 2007 (HHS Reference No. E– 

268–2002/0–US–03). 

Licensing Status: Available for 

exclusive or nonexclusive licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

gPGA Conjugates for Eliciting Immune 

Responses Directed Against Bacillus 

anthracis and Other Bacilli 

Description of Technology: This 

invention claims immunogenic 

conjugates of a poly-g-glutamic acid 

(gPGA) of B. anthracis, or of another 

bacillus that expresses a gPGA that elicit 

a serum antibody response against B. 

anthracis, in mammalian hosts to which 

the conjugates are administered. The 

invention also relates methods which 

are useful for eliciting an immunogenic 

response in mammals, particularly 

humans, including responses which 

provide protection against, or reduce the 

severity of, infections caused by B. 

anthracis. The vaccines claimed in this 

application are intended for active 

immunization for prevention of B. 

anthracis infection, and for preparation 

of immune antibodies. The vaccines of 

this invention are designed to confer 

specific immunity against infection with 

B. anthracis, and to induce antibodies 

specific to B. anthracis gPGA. The B. 

anthracis vaccine is composed of nontoxic bacterial components, suitable for 

infants, children of all ages, and adults. 

Inventors: Rachel Schneerson 

(NICHD), Stephen Leppla (NIAID), John 

Robbins (NICHD), Joseph Shiloach 

(NIDDK), Joanna Kubler-Kielb (NICHD), 

Darrell Liu (NIDCR), Fathy Majadly 

(NICHD). 

Publication: R Schneerson et al. 

Poly(gamma-D-glutamic acid) protein 

conjugates induce IgG antibodies in 

mice to the capsule of Bacillus 

anthracis: a potential addition to the 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 188 / Friday, September 26, 2008 / Notices 55855 

anthrax vaccine. Proc Natl Acad Sci 

USA. 2003 Jul 22;100(15):8945–8950. 

Patent Status: U.S. Patent Application 

No. 10/559,825 filed 02 Dec 2005, 

claiming priority to 05 Jun 2003 (HHS 

Reference No. E–343–2002/0–US–04). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

Improved Bacterial Host for Production 

of Anthrax Toxin Proteins and 

Vaccines: Bacillus anthracis BH450 

Description of Invention: Anthrax 

toxin has previously been made from 

various avirulent strains of Bacillus 

anthracis. The inventors have 

genetically engineered a new strain of B. 

anthracis with improved properties. 

The strain, designated BH450, is totally 

deficient in the ability to make spores 

and to produce a major extracellular 

protease designated Peptidase M4. The 

genetic lesions introduced are defined, 

true deletions, so there is no possibility 

of reversion. Inability to make spores 

assures that laboratories growing the 

strain will not become contaminated 

with the very stable anthrax spores. 

Inability to make peptidase M4 

increases the stability of proteins such 

as anthrax toxin that are secreted to the 

culture medium. 

Applications and Modality: B. 

anthracis vaccine/prophylactic and 

therapeutic studies. 

Market: Research tool useful for 

biodefense/therapeutic studies. 

Development Status: The technology 

is a research tool. 

Inventors: Andrei Pomerantsev, Dana 

Hsu, Ramakrishnan Sitaraman, Craig 

Galloway, Violetta Kivovich, Stephen 

Leppla (NIAID). 

Publication: AP Pomerantsev et al. 

Genome engineering in Bacillus 

anthracis using Cre recombinase. Infect 

Immun. 2006 Jan;74(1):682–693. 

Patent Status: HHS Reference No. E– 

127–2007/0—Research Tool. 

Licensing Status: This technology is 

not patented. The strain will be 

transferred through a Biological 

Materials License. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Allergy and 

Infectious Diseases, Laboratory of 

Bacterial Diseases, is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize Bacillus anthracis BH450 

strain. Please contact Dr. Andrei P. 

Pomerantsev at phone 301/451–9817 

and/or e-mail 

apomerantsev@niaid.nih.gov for more 

information. 

Monoclonal Antibodies That Neutralize 

B. anthracis Protective Antigen (PA), 

Lethal Factor (LF) and Edema Factor 

(EF) 

Description of Invention: Anthrax, 

whether resulting from natural or 

bioterrorist-associated exposure, is a 

constant threat to human health. The 

lethality of anthrax is primarily the 

result of the effects of anthrax toxin, 

which has 3 components: a receptorbinding protein known as ‘‘protective 

antigen’’ (PA) and 2 catalytic proteins 

known as ‘‘lethal factor’’ (LF) and 

‘‘edema factor’’ (EF). Although 

production of an efficient anthrax 

vaccine is an ultimate goal, the benefits 

of vaccination can be expected only if 

a large proportion of the population at 

risk is immunized. The low incidence of 

anthrax suggests that large-scale 

vaccination may not be the most 

efficient means of controlling this 

disease. In contrast, passive 

administration of neutralizing human or 

chimpanzee monoclonal antibody to a 

subject at risk for anthrax or exposed to 

anthrax could provide immediate 

efficacy for emergency prophylaxis 

against or treatment of anthrax. 

Four monoclonal antibodies (mAbs) 

against PA, three mAbs against LF and 

four mAbs specific for EF of anthrax 

were isolated from a phage display 

library generated from immunized 

chimpanzees. Two mAbs recognizing 

PA (W1 and W2), two anti-LF mAbs 

efficiently neutralized the cytotoxicity 

of lethal toxin in a macrophage lysis 

assay. One anti-EF mAb efficiently 

neutralized edema toxin in cell culture. 

All five neutralizing mAbs protected 

animals from anthrax toxin challenge. 

Application: Prophylactics or 

therapeutics against B. anthracis. 

Developmental Status: Preclinical 

studies have been performed. 

Inventors: Zhaochun Chen, Robert 

Purcell, Suzanne Emerson, Stephen 

Leppla, Mahtab Moyeri (NIAID). 

Publication: Z Chen et al. Efficient 

neutralization of anthrax toxin by 

chimpanzee monoclonal antibodies 

against protective antigen. J Infect Dis. 

2006 Mar 1;193(5):625–633. 

Patent Status: PCT Application No. 

PCT/US2008/054609 filed 21 Feb 2008, 

claiming priority to 23 Feb 2007 (HHS 

Reference No. E–123–2007/0–PCT–02); 

U.S. Patent Application No. 11/793,735 

filed 22 Jun 2007 (HHS Reference No. 

E–146–2004/0–US–03) 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Allergy and 

Infectious Diseases, Laboratory of 

Infectious Diseases is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize Chimpanzee/human 

neutralizing monoclonal antibodies 

against anthrax toxins. Please contact 

Dr. Robert Purcell at 301/496–5090 for 

more information. 

Dated: September 18, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–22608 Filed 9–25–08; 8:45 am] 

BILLING CODE 4140–01–P 

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. 

Inhibitors of the Plasmodial Surface 

Anion Channel as Antimalarials 

Description of Technology: The 

inventions described herein are 

antimalarial small molecule inhibitors 

of the plasmodial surface anion channel 

(PSAC), an essential nutrient acquisition 

ion channel expressed on human 


jlentini on PROD1PC65 with NOTICES