55858 Federal Register / Vol. 73, No. 188 / Friday, September 26, 2008 / Notices 

individuals using influenza whole 

genome phage display at 

‘‘Immunobiology and Pathogenesis of 

Influenza Infection’’, Atlanta: June 1–3, 

2008. (poster presentation). 

Patent Status: International Patent 

Application PCT/US2008/067001 filed 

13 Jun 2008 (HHS Reference No. E–236– 

2007/3–PCT–01). 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Kevin W. Chang, 

Ph.D.; 301–435–5018; 

changke@mail.nih.gov. 

Collaborative Research Opportunity: 

The FDA, Center for Biologics 

Evaluation and Research (CBER), 

Division of Viral Products, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize these peptides as vaccine 

candidates or diagnostics. Please contact 

Alice Welch at alice.welch@fda.hhs.gov 

or 301–827–0359 for more information. 

A Rapid Ultrasensitive Assay for 

Detecting Prions Based on the Seeded 

Polymerization of Recombinant Normal 

Prion Protein (rPrP-sen) 

Description of Technology: Prion 

diseases are neurodegenerative diseases 

of great public concern because humans 

may be infected from hoofed animals 

used as food, food products such as 

milk, or blood products. Currently 

available tests for disease-causing prions 

are either incapable of detecting low 

concentrations of prions and must be 

used post-mortem or are incapable of 

detecting low concentrations of prions 

economically or accurately. This 

technology enables rapid and 

economical detection of sub-lethal 

concentrations of prions by using 

recombinant, normal, prion protein 

(rPrP-sen) as a marker or indicator of 

infectious prions in a sample. 

Specifically, prions (contained in a 

sample) seed the polymerization of 

rPrP-sen, and polymerized rPrP-sen is 

detected as an amplified indicator of 

prions in the sample. This assay differs 

from the protein-misfolding cyclic 

amplification assay (PMCA) because it 

enables the effective use of rPrP-sen and 

does not require multiple amplification 

cycles unless a higher degree of 

sensitivity is required. It is anticipated 

that this technology can be combined 

with additional prion-detection 

technologies to further improve the 

sensitivity of the assay. In its current 

embodiment, this assay has been used to 

detect prions in brain tissue or cerebral 

spinal fluid (CSF) from humans (variant 

CJD), sheep (scrapie), and hamsters 

(scrapie). 

Advantages: 

• Uses a consistent, concentrated 

source of normal prion protein (rPrPsen) 

• Prions are detectable to low levels 

after a single amplification round 

• May be combined with 

complimentary detection technologies 

to improve sensitivity 

• Demonstrated to be effective at 

detecting prions from different species 

• May be applicable to blood 

products 

• Economical 

Applications: 

• A test for live animals or food 

products 

• A human diagnostic for early 

detection of prion diseases 

• Monitor for effectiveness of 

treatments or disease progression 

Inventors: Byron W. Caughey, 

Ryuichiro Atarashi, Roger A. Moore, 

and Suzette A. Priola (NIAID). 

Related Publications: 

1. R Atarashi et al. Simplified 

ultrasensitive prion detection by 

recombinant PrP conversion with 

shaking. Nat Methods 2008 

Mar;5(3):211–212. 

2. R Atarashi et al. Ultrasensitive 

detection of scrapie prion protein using 

seeded conversion of recombinant prion 

protein. Nat Methods 2007 

Aug;4(8):645–650. 

Patent Status: 

• PCT Application No. PCT/US2008/ 

070656 filed 21 Jul 2008 (HHS 

Reference No. E–109–2007/1–PCT–01). 

• U.S. Application No. 12/177,012 

filed 21 Jul 2008 (HHS Reference No. E– 

109–2007/1–US–02). 

Licensing Status: Available for 

exclusive and non-exclusive licensing. 

Licensing Contact: RC Tang, JD, LLM; 

301–435–5031; tangrc@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIAID Laboratory of Persistent 

Viral Diseases, TSE/Prion Biochemistry 

Section, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize this technology. Please 

contact Rosemary Walsh at 301–451– 

3528 or rcwalsh@niaid.nih.gov. 

Dated: September 18, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–22610 Filed 9–25–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; 

Amended Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Institute of 

Diabetes and Digestive and Kidney 

Diseases Special Emphasis Panel, 

October 17, 2008, 2:30 p.m. to 3:30 p.m., 

National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 which 

was published in the Federal Register 

on September 11, 2008, 73 FR 0177. 

This meeting will be held October 22, 

2008 instead of October 17, 2008. The 

meeting is closed to the public. 

Dated: September 18, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–22604 Filed 9–25–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), 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: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, Molecular Therapy 

Core Centers. 

Date: October 21, 2008. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Michele L. Barnard, PhD, 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 753, 6707 Democracy Boulevard, 


jlentini on PROD1PC65 with NOTICES