70010 Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices 

Consumer/Patient Perspective 

• How could HRA data be shared 

with the patients for their feedback and 

follow up in the primary care practice? 

• What role, if any, do incentives play 

in motivating patients to take the HRA 

and/or participate in follow-up 

interventions? 

Data 

• With respect to Information 

Technology (IT), how could HRA data 

entered in any form populate electronic 

health records, and what special 

challenges and solutions occur if the 

data are entered in a non-electronic 

form? 

• Are there standardized and certified 

tools available to support this data 

migration from multiple data entry 

sources? 

Certification 

• What certification tools and 

processes should complement the HRA 

guidance and how should they be made 

available to support primary care office 

selection of an HRA instrument? 

Evaluation and Quality Assurance 

• How should the HRA guidance be 

evaluated and updated with respect to 

individual and population-level 

(practice-based panel management) 

health outcomes? 

Public Forum: CDC plans to convene 

a public forum in early February 2011 

to highlight some of the key challenges, 

barriers, opportunities and innovations 

related to HRA standardization. The 

public forum will consist of panel 

presentations followed by public 

comment. CDC will publish a separate 

notice in the Federal Register 

announcing additional information for 

the Public Forum. 

Dated: November 8, 2010. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2010–28788 Filed 11–15–10; 8:45 am] 

BILLING CODE 4163–18–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. 

Novel Anti-HIV Acylthiol Drugs and 

Thioether Prodrugs 

Description of Invention: The 

inventions provide the compositions, 

pharmaceutical carrier, and usages of 

the new Acylthiols (E–329–2000 family) 

and Thioether pro-drug (E–177–2010 

family) compounds in treatment of 

retroviral infections such as HIV. More 

specifically, these compounds target the 

highly-conserved nucleocapsid protein 

of HIV–1. Activity of these compounds 

against the nucleocapsid protein leads 

to inactivation of the virus via 

disruption of the zinc fingers, integral 

for infectivity, without significantly 

affecting cellular proteins. Finally, these 

inventions can be prepared from 

inexpensive starting materials and two 

‘‘one-pot’’ reactions. Thus, they open the 

possibility for an effective drug 

treatment for HIV that could reach 

underdeveloped countries. These new 

compounds have the potential to be 

used both as a systemic drug for the 

treatment of HIV–1 infection and as a 

topically-applied barrier to prevent viral 

transmission. 

Applications: Treatment and 

prevention of HIV infections. 

Advantages: 

• Potent anti-HIV activity. 

• Could be used both systemically 

and locally. 

• Unlikely to develop any drug 

resistance. 

• Can be inexpensively manufactured 

in a large scale. 

Development Status: In vitro data 

available. 

Market: According to the 2008 

UNAIDS report, there were 33 million 

people living with AIDS in 2007, with 

2.7 million new cases occurring in that 

year. In the US alone, there are 1.2 

million AIDS patients. 

The anti-HIV drug market is among 

the fastest-growing pharmaceutical 

markets in the world. Due to the large 

target market, duration of therapy 

(lifetime), and nature of the disease 

(incurable), manufacturers will continue 

to benefit from technological 

advancements. In 2007, the seven Major 

Markets (7MM; US, Japan, Italy, 

Germany, UK, Spain and France) 

generated $9.3B in sales of antiretroviral 

drugs. These markets are expected to 

grow to $15.1B by 2017. 

The current product market segments 

for anti-retrovirals are: protease 

inhibitors (PI), nucleoside reverse 

transcriptase inhibitors (NRTI), nonnucleoside reverse transcriptase 

inhibitors (NNRTI), entry inhibitors (EI), 

integrase inhibitors (II), and maturation 

inhibitors (Other). 

Inventors: Daniel Appella (NIDDK), 

Ettore Appella (NCI), John K. Inman 

(NIAID), Deyun Wang (NIDDK), Lisa M. 

Miller Jenkins (NCI), Ryo Hayashi (NCI). 

Publications: 

1. Miller Jenkins LM, et al. Nature 

Chemical Biology, in press. 

2. Miller Jenkins LM, et al. Specificity 

of acyl transfer from 2- 

mercaptobenzamide thioesters to the 

HIV–1 nucleocapsid protein. J Am 

Chem Soc. 2007 Sep12;129(36):11067– 

11078. [PubMed: 17705474] 

3. Schito ML, et al. In vivo antiviral 

activity of novel human 

immunodeficiency virus type 1 

nucleocapsid p7 zinc finger inhibitors 

in a transgenic murine model. AIDS Res 

Hum Retroviruses. 2003 Feb;19:91–101. 

[PubMed: 12639244] 

Patent Status: 

• U.S. Provisional Application No. 

61/353,274 filed 10 Jun 2010 (HHS 

Reference No. E–177–2010/0–US–01). 

• PCT/US02/23924 (HHS Reference 

No. E–329–2000/0–PCT–02) and entered 

national stage in the U.S. (Patent No. 

7,528,274 and Patent Application No. 

12/414,321), Canada (Patent Application 

No. 2456083), Australia (Patent No. 

2002322721), and Europe (Patent 

Application No. 02756732.0). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Sally Hu, Ph.D.; 

301–435–5606; HuS@mail.nih.gov. 

Collaborative Research Opportunity: 

The Laboratory of Cell Biology, Center 

for Cancer Research is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize the above invention for 

the treatment/prevention of HIV 

infection. Please contact John Hewes, 

Ph.D. at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

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Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices 70011 

Scanningless Multiphoton Microscopy 

with Diffraction-Limited Axial 

Resolution 

Description of Invention: The 

technology offered for licensing is a 

scanningless multiphoton microscope 

for performing 3-dimensional imaging 

that achieves diffraction-limited 

resolution. The microscope combines 

temporal multiplexing with spatial 

dispersion to achieve diffraction-limited 

resolution without having to 

mechanically scan the sample (a field of 

view up to 30x30 microns). The widefield excitation of the sample allows 

imaging rates in excess to prior art 

multiphoton microscopes while still 

achieving diffraction-limited axial 

resolution. The microscope includes a 

laser source that generates a 

femtosecond laser beam that passes 

through a stair-step optic having a 

variable thickness piece of glass 

arranged such that each ‘‘strip’’ of the 

laser beam is delivered at a different 

relative delay. Each strip exits the stairstep optic and is imaged onto the 

surface of a diffraction grating by two 

imaging lenses and a mirror. The 

diffraction grating sends the different 

wavelengths that compose each 

horizontal strip of the laser beam in 

different directions. Another pair of 

lenses, such as the imaging lens and 

objective lens (e.g., high numerical 

aperture objective) images and demagnifies the surface of the diffractive 

grating into a biological sample that 

causes an excitation to occur in the 

sample. The ensuing excitation 

generates fluorescence in the sample 

confined to the focal plane of the 

objective lens, where the excitation is 

maximized. The fluorescence is 

collected through the objective lens and 

then by a CCD camera. 

Applications: 

• The invention provides a high 

resolution multiphoton microscopy 

device to the laboratory instrumentation 

market. 

• The uses of such a device would 

predominantly be for research in 

biological imaging. 

• The device provides the ability to 

image a large frame rapidly and with 

relatively low energy and thus without 

burning the sample or destroying 

subcellular structures. 

Inventors: Hari Shroff and Andrew 

York (NIBIB). 

Patent Status: U.S. Provisional 

Application No. 61/385,409 filed 22 Sep 

2010 (HHS Reference No. E–105–2010/ 

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; ShmilovichM@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Biomedical 

Imaging and Bioengineering Section on 

High Resolution Optical Imaging is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize this 

invention. Please contact Dr. Henry 

Eden at edenh@mail.nih.gov for more 

information. 

Myosin-Based Protein-Protein 

Interaction Assay 

Description of Invention: Investigators 

at the National Institute on Deafness and 

Other Communication Disorders 

(NIDCD) have developed an assay for 

the detection of protein-protein 

interactions in living cells. This assay 

uses readily-available reagents and 

straightforward techniques that avoid 

the difficulty of purifying proteins or 

generating antibodies required for other 

binding studies. Proof-of-concept for 

this assay has been demonstrated, and a 

manuscript is in preparation for 

publication. 

This technology utilizes a molecular 

motor, myosin X, which migrates along 

actin filaments within cells. A protein 

fused to a fragment of myosin X will 

carry its binding partners to the cell 

periphery. Since the myosin fusion 

protein and its partner are labeled with 

different fluorescent tags, an 

unambiguous fluorescence overlap will 

be visible as discrete points along the 

periphery of the cell. The inventors 

have designed a number of cDNAs for 

the construction of fusion proteins 

appropriate for such an assay. 

Available for licensing are a variety of 

cDNAs which may be used for 

generating fluorescently-tagged myosin 

X fusion proteins, for use in the assay 

described above. Also available are a 

number of constructs incorporating 

other fluorescently-tagged myosins, 

kinesins, myosin and kinesin binding 

partners and a variety of PDZ scaffold 

proteins. Further details of the available 

cDNAs are available upon request. 

Applications: 

• Identification of protein-protein 

binding interactions in living cells. 

• DNA-based tools for study of 

myosins, trafficking, signaling 

complexes and other research focusing 

on molecular motors. 

Advantages: 

• Assay avoids the need to purify 

proteins or generate antibodies for 

binding studies. 

• Protein-protein interactions can be 

unambiguously identified. 

Development Status: Proof of concept 

has been demonstrated. 

Inventors: Erich T. Boger, Inna A. 

Belyantseva, Thomas B. Friedman 

(NIDCD). 

Relevant Publication: Belyantseva IA 

et al. Myosin-XVa is required for tip 

localization of whirlin and differential 

elongation of hair-cell stereocilia. Nat 

Cell Biol. 2005 Feb;7(2):148–156. 

[PubMed: 15654330] 

Patent Status: HHS Reference Nos. E– 

069–2009/0, E–069–2009/1, E–069– 

2009/2, E–069–2009/3, E–069–2009/4, 

E–069–2009/5, E–069–2009/6, and E– 

069–2009/7—Research Tool. Patent 

protection is not being sought for this 

invention. 

Licensing Status: Available for 

licensing under a Biological Materials 

License Agreement. 

Licensing Contact: Tara L. Kirby, 

Ph.D.; 301–435–4426; 

tarak@mail.nih.gov. 

Dated: November 9, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–28847 Filed 11–15–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0448] 

Guidance for Industry, Mammography 

Quality Standards Act Inspectors, and 

Food and Drug Administration Staff; 

The Mammography Quality Standards 

Act Final Regulations: Modifications 

and Additions to Policy Guidance Help 

System #13; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘The Mammography Quality Standards 

Act Final Regulations: Modifications 

and Additions to Policy Guidance Help 

System #13.’’ This document is intended 

to assist mammography facilities and 

their personnel in meeting the 

requirements of the Mammography 

Quality Standards Act (MQSA) 

regulations. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

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