54346 Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices 

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. 

Vortex Counter-Current 

Chromatography (CCC) System 

Description of Invention: Available for 

licensing and commercial development 

is a vortex counter-current 

chromatography system. The system has 

a rotary frame engaged to a vortex 

separation column for rotation in one 

direction through a vortex separation 

shaft engaged to a pulley system. The 

rotary frame is engaged to a central shaft 

that rotates the rotary frame in a 

direction opposite that of the vortex 

separation column such that planetary 

motion is imparted to the vortex 

separation column. The vortex 

separation column may be configured to 

receive a solvent system separable 

between two immiscible liquid phases 

introduced into the vortex separation 

column. A pulley system is operatively 

engaged to the separation column shaft 

and the central shaft for rotating the 

separation column shaft and the cortex 

separation column in a synchronous 

rotational direction opposite to the 

rotational direction of the rotary frame 

for imparting a type-I planetary motion 

to the vortex separation column. A 

counter-weight column is engaged at a 

symmetrical position opposite the 

vortex separation column along the 

rotary frame, wherein the two 

immiscible liquid phases undergo a 

vortex motion during rotation of the 

vortex separation column such that 

mixing of the two immiscible liquid 

phases takes place with a plane 

perpendicular to an axis of the vortex 

separation column. 

Compared with conventional CCC 

systems, the vortex system has much 

higher partition efficiency in terms of 

height equivalent to a theoretical plate 

(only 2 cm compared with 20 cm that 

is required for the conventional system). 

The vortex system also provides an 

advantage of low column pressure 

which facilitates application of a large 

industrial-scale separation without a 

risk of leakage of solvent and column 

damage caused by high pressure. 

Applications 

• Drug Discovery. 

• Chromatography. 

• Natural Products Research. 

Inventors: Yoichiro Ito (NHLBI). 

Publications 

1. Ito Y, Bowman RL. Countercurrent 

chromatography with flow-through coil 

planet centrifuge. Science 

1971;173:420–422. [PubMed: 5557320] 

2. Ito Y, Bowman RL. Countercurrent 

chromatography with flow-through coil 

planet centrifuge. J Chromatogr Sci. 

1973;11:284–291. 

Patent Status: U.S. Provisional 

Application No. 61/368,157 filed 27 Jul 

2010 (HHS Reference No. E–196–2010/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Michael A. 

Shmilovich, Esq.; 301–435–5019; 

shmilovm@mail.nih.gov. 

Superresolution Microscopy via Azicon 

Beam Polarization Devices 

Description of Invention: The 

technology offered for licensing pertains 

to novel polarizers that produce 

tangentially and radially polarized 

beams. The polarizers and polarizing 

beam splitter of the technology include 

one or more pairs of axicons (also 

known as conical lenses) that are 

configured to separate an input beam 

into a radially polarized component and 

a tangentially (or azimuthally) polarized 

component. A second axicon pair can be 

positioned to recombine the tangentially 

polarized component so as to provide a 

more uniform beam intensity. The radial 

polarized component can be reflected or 

otherwise directed so that one or both 

the radial and tangential components 

are available for use. 

Applications 

The disclosed methods and apparatus 

of the technology can be used to provide 

radially or tangentially polarized beams 

(or both) to many applications. In 

particular, the technology can be 

effectively utilized in applications such 

as: 

• Multi-photon microscopy. 

• Microlithography. 

• Ultrafine imaging in conjunction 

with the use of fluorophores. 

Advantages: The technology provides 

higher optical resolution for certain 

applications as compared with currently 

used methodologies. 

Development Status: The invention is 

fully developed. 

Inventors: Jay R. Knutson (NHLBI). 

Patent Status: U.S. Provisional 

Application No. 61/308,202 filed 25 Feb 

2010 (HHS Reference No. E–251–2009/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contacts 

• Uri Reichman, Ph.D., MBA; 301– 

435–4616; UR7a@nih.gov. 

• Michael Shmilovich, Esq.; 301– 

435–5019; shmilovm@mail.nih.gov. 

Collaborative Research Opportunity: 

The NHLBI Laboratory of Molecular 

Biophysics is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize this technology. Please 

contact Brian Bailey at 301–594–4094 

for more information. 

Mucosal Cytotoxic T Lymphocyte 

Responses 

Description of Invention: The 

invention offered for licensing provides 

methods and compositions for 

induction of an antigen-specific, 

mucosal cytotoxic T lymphocyte (CTL) 

response useful in preventing and 

treating infections with pathogens that 

gain entry via a mucosal surface. The 

methods of the invention involve 

administering either a soluble antigen 

itself, or a polynucleotide encoding the 


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Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices 54347 

soluble antigen, to a mucosal surface. 

The soluble antigens can be full length, 

naturally occurring polypeptides or 

fragments (i.e. peptides) derived from 

them. The soluble antigen is 

administered with an adjuvant at the 

mucosal site or without an adjuvant. 

Adjuvants can be, for example, Cholera 

toxin (CT), mutant CT (MCT), E. coli 

heat labile enterotoxin (LT) and others. 

Cytokines like IL–12 or IFNg can also be 

administered to enhance the 

immunoreactivity. Mucosal routes of 

administration include intrarectal (IR), 

intranasal (IN), intragastric (IG), 

intravaginal (IVG) or intratratracheal 

(IT). Soluble antigens can be derived 

from pathogenic viruses (e.g. HIV, 

influenza, or hepatitis virus), bacteria 

(e.g. Listeria monocytogenes), or 

prozoans. Furthermore, the soluble 

antigen can be tumor-associated antigen 

for cancer applications. 

The utility of the technology has been 

extensively demonstrated when applied 

to HIV. Details about the HIV studies are 

provided in the eight (8) publications 

cited below. 

Applications 

• Immunization to treat infectious 

diseases. 

• Possible applications in cancer 

therapy. 

Development Status: Proof of concept 

has been demonstrated, in particular as 

related to HIV. 

Inventors: Jay A. Berzofsky (NCI) et al. 

Relevant Publications 

1. Belyakov IM, Derby MA, Ahlers JD, 

Kelsall BL, Earl P, Moss B, Strober W, 

Berzofsky JA. Mucosal immunization 

with HIV–1 peptide vaccine induces 

mucosal and systemic cytotoxic T 

lymphocytes and protective immunity 

in mice against intrarectal recombinant 

HIV-vaccinia challenge. Proc Natl Acad 

Sci USA. 1998 Feb 17;95(4):1709–1714. 

[PubMed: 9465081] 

2. Belyakov IM, Ahlers, JD, 

Brandwein BY, Earl P, Kelsall B, Moss 

B, Strober W, Berzofsky JA. The 

importance of local mucosal HIVspecific CD8+ cytotoxic T lymphocytes 

for resistance to mucosal viral 

transmission in mice and enhancement 

of resistance by local administration of 

IL–12. J Clin Invest. 1998 Dec 

15;102(12):2072–2081. [PubMed: 

9854042] 

3. Belyakov IM, Ahlers JD, Clements 

JD, Strober W, Berzofsky JA. Interplay of 

cytokines and adjuvants in the 

regulation of mucosal and systemic HIVspecific CTL. J Immunol. 2000 Dec 

1;165(11):6454–6462. [PubMed: 

11086085] 

4. Belyakov IM, Hel Z, Kelsall B, 

Kuznetsov VA, Ahlers JD, Nacsa J, 

Watkins DI, Allen TM, Sette A, Altman 

J, Woodward R, Markham PD, Clements 

JD, Franchini G, Strober W, Berzofsky 

JA. Mucosal AIDS vaccine reduces 

disease and viral load in gut reservoir 

and blood after mucosal infection of 

macaques. Nat Med. 2001 

Dec;7(12):1320–1326. [PubMed: 

11726972] 

5. Belyakov IM, Kuznetsov VA, 

Kelsall B, Klinman D, Moniuszko M, 

Lemon M, Markham PD, Pal R, 

Clements JD, Lewis MG, Strober W, 

Franchini G, Berzofsky JA. Impact of 

vaccine-induced mucosal high avidity 

CD8+ CTLs in delay of AIDS-viral 

dissemination from mucosa. Blood 2006 

Apr 15;107(8):3258–3264. [PubMed: 

16373659] 

6. Belyakov IM, Isakov DV, Zhu Q, 

Dzutsev A, Berzofsky JA. A novel 

functional CTL avidity/activity 

compartmentalization to the site of 

mucosal immunization contributes to 

protection of macaques against simian/ 

human immunodeficiency viral 

depletion of mucosal CD4+ T cells. J 

Immunol. 2007 Jun 1;178(11):7211– 

7221. [PubMed: 17513770] 

7. Belyakov IM, Ahlers JD, Nabel GJ, 

Moss B, Berzofsky JA. Generation of 

functionally active HIV–1 specific CD8+ 

CTL in intestinal mucosa following 

mucosal, systemic, or mixed primeboost immunization. Virology 2008 Nov 

10;381(1):106–115. [PubMed: 18793787] 

8. Sui Y, Zhu Q, Gagnon S, Dzutsev 

A, Terabe M, Vaccari M, Venzon D, 

Klinman D, Strober W, Kelsall B, 

Franchini G, Belyakov IM, Berzofsky JA. 

Innate and adaptive immune correlates 

of vaccine and adjuvant-induced control 

of mucosal transmission of SIV in 

macaques. Proc Natl Acad Sci USA. 

2010 May 25;107(21):9843–9848. 

[PubMed: 20457926] 

Patent Status: HHS Reference No. E– 

268–1997/2— 

• U.S. Patent Application No. 09/ 

508,552, which issued as U.S. Patent 

No. 6,749,856 on 15 Jun 2004. 

• Foreign patents issued in Australia 

(Application Number 93862/98 and 

Patent Number 757310) and in 

European countries (Application 

Number 98946965.5 and Patent Number 

1011720): Germany, France, Ireland, 

United Kingdom, Italy, Portugal and 

Spain. 

• Divisional U.S. Patent Application 

No. 10/815,340 filed 30 Mar 2004. 

Licensing Status: Available for 

licensing and commercial development. 

Licensing Contacts: Uri Reichman, 

PhD, MBA; 301–435–4616; 

UR7a@nih.gov; or John Stansberry, PhD; 

301–435–5236; js852e@nih.gov. 

Collaborative Research Opportunity: 

The Center for Cancer Research, Vaccine 

Branch, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize Mucosal Cytotoxic T 

Lymphocyte Responses. Please contact 

John D. Hewes, PhD at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

Dated: August 31, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–22182 Filed 9–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0426] 

Draft Guidance for Industry: Bar Code 

Label Requirements—Questions and 

Answers (Question 12 Update); 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for Industry: Bar Code Label 

Requirements—Questions and Answers 

(Question 12 Update)’’ dated August 

2010. This draft guidance provides you, 

manufacturers of a licensed vaccine, 

with advice concerning compliance 

with the bar code label requirements. In 

this guidance, FDA is proposing to 

amend our response to question 12 

(Q12) in the ‘‘Bar Code Label 

Requirements—Questions and Answers’’ 

guidance dated October 2006 (Bar Code 

Guidance), to provide recommendations 

to manufacturers of licensed vaccines in 

connection with the use of alternative 

coding technologies. When this 

guidance is finalized, we intend to 

incorporate the revised response to Q12 

into the Bar Code Guidance, but 

otherwise continue with our 

recommendations for bar code label 

requirements as currently provided in 

the Bar Code Guidance. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1