Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices 70009 

Estimated Total Annual Burden 

Hours: 630. 

Additional Information: 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Fax: 202– 

395–7285, E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: November 10, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–28855 Filed 11–15–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Development of Health Risk 

Assessment Guidance 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Request for Information. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) located 

within the Department of Health and 

Human Services (HHS) is seeking public 

comment on the development of 

guidance concerning Health Risk 

Assessment (HRAs). Section 4103 of the 

Affordable Care Act (ACA) (Pub. L. 111– 

148) requires that a health risk 

assessment be included in the annual 

wellness visit benefit authorized for 

Medicare beneficiaries under the ACA. 

CDC is collaborating with the Centers 

for Medicare and Medicaid Services 

(CMS), also located within HHS, in the 

development of guidance for this type of 

assessment. This guidance is also 

intended to be useful for HRAs 

conducted in other patient populations 

such as privately insured populations, 

including those persons covered by 

employer healthcare plans. Comments 

received from this request for 

information will be used to inform the 

HRA guidance development process. 

DATES: Written comments must be 

received on or before January 3, 2011. 

Comments received after January 3, 

2011 will be considered to the extent 

possible. 

ADDRESSES: You may submit written 

comments to the following address: 

Office of Prevention through Healthcare, 

Office of the Associate Director for 

Policy, Centers for Disease Control and 

Prevention, 1600 Clifton Road, NE., 

Mailstop D–28, Atlanta, Georgia, 30333, 

ATTN: Health Risk Assessment 

Guidance. 

You may also submit written 

comments via e-mail to: OPTH@cdc.gov. 

Please use ‘‘Health Risk Assessment 

Guidance’’ for the subject line. 

Submitted comments will be available 

for public review from Monday through 

Friday, except for legal holidays, from 9 

a.m. until 5 p.m. Eastern Standard Time, 

at 1600 Clifton Road NE., Atlanta, 

Georgia 30333. Please call ahead to 1– 

404–639–0210 and ask for a 

representative in the Office of 

Prevention through Healthcare to 

schedule your visit. Comments will also 

be available for viewing at the following 

Internet address: http://www.cdc.gov/ 

policy/opth/. 

CDC will make all comments it 

receives available to the public without 

change, including personal information 

you may provide, which includes the 

name of the person submitting the 

comment or signing the comment on 

behalf of an organization, business, or 

any such entity. If anyone does not wish 

to have this information published, then 

that information should not be included 

when submitting the comment. 

FOR FURTHER INFORMATION CONTACT: 

Paula Staley, Office of Prevention 

through Healthcare, Associate Director 

for Policy, Centers for Disease Control 

and Prevention, 1600 Clifton Road, NE., 

Mailstop D–28, Atlanta, Georgia, 30333, 

telephone: (404) 639–0210. 

SUPPLEMENTARY INFORMATION: 

Section 4103 of the Affordable Care 

Act (ACA) requires that a health risk 

assessment be included in the annual 

wellness visit benefit authorized for 

Medicare beneficiaries under the ACA. 

CDC is collaborating with CMS to 

develop guidance for this type of 

assessment. This guidance is also 

intended to be useful for HRAs 

conducted in other patient populations 

such as privately insured populations, 

including those persons covered by 

employer healthcare plans. 

Currently there is considerable 

variation in available HRAs, with the 

majority of assessments created to 

support employer-based health and 

wellness programs. Several instruments 

have been created for use in research 

and are not available in the marketplace; 

and the scientific rigor of HRA tools is 

not always evident. Therefore, the 

development of HRA guidance is 

essential for effective implementation of 

this part of the Medicare wellness visit 

and to support broader HRA use within 

primary care. 

Although comments on any aspect of 

the guidance development process will 

be accepted, comments are especially 

solicited about these areas of emphasis: 

Content and Design 

• Risk assessment domains—What 

are generic elements of any HRA and 

what elements must be tailored to 

specific populations, particularly those 

stratified by age? 

• How should literacy and other 

cultural appropriateness factors be 

factored into the design? 

• How should the HRA instrument 

support shared decision-making by 

provider and patient? 

Mode of Administration 

• How will individuals access the 

HRA (e.g., via kiosk or some other 

means in the physician’s office, Internet, 

mail-in paper form, other nontraditional healthcare locations, such as, 

kiosk in a pharmacy)? 

• What are the cultural 

appropriateness factors in patient HRA 

access? 

Primary Care Office Capacity 

• What primary care office capacity 

(personnel, Information Technology 

(IT), etc) is required to utilize HRA data 

effectively in support of personalized 

prevention planning? 

• Are training and technical 

assistance necessary for effective 

practice utilization of an HRA? What 

entity should provide this technical 

assistance? 

• What are potential or demonstrated 

community care transition linkages— 

follow-up outside the office by other 

providers—that help patients and 

providers manage priority risks 

identified by the HRA? 

• What is the current practice of HRA 

in medical practices of various sizes, 

particularly those with five or fewer 

physicians? 

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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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