53262 Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 

Proposed Project 

Field Test of Communication and 

Marketing Variables for Health 

Protection—New—National Center for 

Health Marketing/Coordinating Center 

for Health Information Service (NCHM/ 

CCHIS), Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

CDC does not have a mechanism to 

assess and monitor the health 

communication and marketing 

components of health protection. While 

CDC does invest in formative and 

process evaluation of specific health 

communication and marketing programs 

and projects, the common elements 

rooted in communication and marketing 

theories and constructs are not 

identified across programs and projects, 

nor frequently compared after the fact to 

ascertain the underlying factors and 

dynamics that inform and shape 

individual and group behaviors and 

actions. The purpose of this project is to 

develop a core set of communication 

and marketing variables that can be 

used to inform CDC health protection 

programs and projects as well as track 

population-level changes over time. 

The proposed data collection is to 

conduct a field test of the survey 

instrument focusing on the core 

communication and marketing 

constructs for health protection 

behaviors. The field test survey will be 

administered to a purposive sample of 

1,925 respondents. Two modes of 

administration will be tested, telephone 

(both landline and cell) and selfadministration via the Web. The 

telephone survey will be conducted in 

five geographical locations. The Web 

survey will use an on-going national 

consumer panel. 

Rather than randomly sampling from 

the population, CDC has identified 

subpopulations of particular interest 

and interviewers will achieve quotas of 

completed interviews from each group. 

This purposive sampling is designed to 

reach adult persons who are vulnerable 

from a health protection perspective. It 

is of particular importance to interview 

those known to have low health literacy, 

that is, difficulty accessing and/or 

understanding health messages so CDC 

can work to meet their needs. Therefore, 

included in the target groups are the 

elderly, who may be somewhat isolated 

and for whom health messages may be 

confusing; people of low socioeconomic 

status (SES), whose level of education 

can be a barrier to comprehending and 

following health messages; and persons 

not fluent in English, for whom 

innovative ways of communicating 

health messages may be necessary. In 

addition to English, interviews will be 

conducted in three other languages, 

Spanish, Cantonese and Vietnamese. 

Members of the general population will 

be surveyed as well in order to provide 

a benchmark for the subpopulations of 

interest. Demographic variables that will 

be used to screen respondents into the 

subpopulations of interest include age, 

education, and race and ethnicity. 

Interviewing will continue with specific 

subpopulations until quotas are 

reached. Incentives will not be provided 

to survey respondents. 

CDC will use the field test data to 

assess continuity of response patterns 

within each of the subgroups and to 

determine differences in administration 

time. In addition to subgroup 

population differences in attitudes, 

beliefs, and health behaviors, CDC will 

use the data to examine item-level mode 

effects, regional differences, and 

administrative/logistical barriers to 

guide the design of core measure 

surveys for other health protection 

behaviors. There is no cost to 

respondents other than their time to 

complete the survey. The total estimated 

annual burden hours are 1,222. 

ESTIMATED ANNUALIZED BURDEN HOURS

Forms and respondents Number of 

respondents 

Number of responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Screener ...................................................................................................................................... 19,250 1 2/60 

Survey: General Population ......................................................................................................... 1,000 1 18/60 

Survey: Elderly ............................................................................................................................. 275 1 18/60 

Survey: Low SES ......................................................................................................................... 275 1 18/60 

Survey: Low SES African American ............................................................................................ 150 1 18/60 

Survey: Hispanic .......................................................................................................................... 75 1 18/60 

Survey: Chinese .......................................................................................................................... 75 1 18/60 

Survey: Vietnamese ..................................................................................................................... 75 1 18/60 

Dated: October 8, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–24941 Filed 10–15–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will publish periodic summaries of 

proposed projects. To request more 

information on the proposed projects or 

to obtain a copy of the information 

collection plans, call the SAMHSA 

Reports Clearance Officer on (240) 276– 

1243. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 53263 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: Regulations To 

Implement SAMHSA’s Charitable 

Choice Statutory Provisions—42 CFR 

Parts 54 and 54a (OMB No. 0930– 

0242)—Revision 

Section 1955 of the Public Health 

Service Act (42 U.S.C. 300x–65), as 

amended by the Children’s Health Act 

of 2000 (Pub. L. 106–310) and Sections 

581–584 of the Public Health Service 

Act (42 U.S.C. 290kk et seq., as added 

by the Consolidated Appropriations Act 

(Pub. L. 106–554)), set forth various 

provisions which aim to ensure that 

religious organizations are able to 

compete on an equal footing for Federal 

funds to provide substance abuse 

services. These provisions allow 

religious organizations to offer 

substance abuse services to individuals 

without impairing the religious 

character of the organizations or the 

religious freedom of the individuals 

who receive the services. The provisions 

apply to the Substance Abuse 

Prevention and Treatment Block Grant 

(SAPT BG), to the Projects for 

Assistance in Transition from 

Homelessness (PATH) formula grant 

program, and to certain Substance 

Abuse and Mental Health Services 

Administration (SAMHSA) 

discretionary grant programs (programs 

that pay for substance abuse treatment 

and prevention services, not for certain 

infrastructure and technical assistance 

activities). Every effort has been made to 

assure that the reporting, recordkeeping 

and disclosure requirements of the 

proposed regulations allow maximum 

flexibility in implementation and 

impose minimum burden. 

No changes are being made to the 

regulations. This revision is for approval 

of the updated estimate of burden on 

respondents to provide the information 

required to be reported by 42 CFR part 

54a.8(d) and 54.8(e), respectively, and to 

ascertain how they are implementing 

the disclosure requirements of 54a.8(b) 

and 54.8(b), respectively. Information 

on how States comply with the 

requirements of 42 CFR part 54 was 

approved by the Office of Management 

and Budget (OMB) as part of the 

Substance Abuse Prevention and 

Treatment Block Grant FY 2008–2010 

annual application and reporting 

requirements approved under OMB 

control number 0930–0080. 

42 CFR Citation and purpose Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response Total hours 

Part 54—States Receiving SAPT Block Grants and/or Projects for Assistance in Transition From Homelessness 

Reporting: 

96.122(f)(5) Annual report of activities the State undertook to comply 42 CFR Part 54 (SAPT BG) ..... 60 1 60 1 60 

54.8(c)(4) Total number of referrals to alternative 

service providers reported by program participants 

to States (respondents). 

SAPT BG ............................................................. 7 *68 476 1 476 

PATH ................................................................... 0 5 50 1 50 

54.8(e) Annual report by PATH grantees on activities 

undertaken to comply with 42 CFR Part 54 56 1 56 1 56 

Disclosure: 

54.8(b) State requires program participants to provide notice to program beneficiaries of their right 

to referral to an alternative service provider. 

SAPT BG ............................................................. 60 1 60 .05 3 

PATH ................................................................... 56 1 56 .05 3 

Recordkeeping: 

54.6(b) Documentation must be maintained to demonstrate significant burden for program participants under 42 U.S.C. 300x–57 or 42 U.S.C. 

290cc–33(a)(2) and under 42 U.S.C. 290cc–21 to 

290cc–35 60 1 60 1 60 

Part 54—Subtotal ................................................ 116 ........................ 818 .......................... 708 

Part 54a—States, local governments and religious organizations receiving funding under Title V of the PHS Act for substance abuse 

prevention and treatment services 

Reporting: 

54a.8(c)(1)(iv) Total number of referrals to alternative service providers reported by program participants to States when they are the responsible 

unit of government .................................................. 25 4 100 .083 8 

54a(8)(d) Total number of referrals reported to 

SAMHSA when it is the responsible unit of government. (NOTE: This notification will occur during 

the course of the regular reports that may be required under the terms of the funding award.) ....... 20 2 40 .25 10 

Disclosure: 

54a.8(b) Program participant notice to program 

beneficiaries of rights to referral to an alternative 

service provider ....................................................... 1,460 1 1,460 1 1,460 

Part 54a—Subtotal .............................................. 1,505 ........................ 1,600 .......................... 1,478 


jlentini on DSKJ8SOYB1PROD with NOTICES
53264 Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 

42 CFR Citation and purpose Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response Total hours 

Total ..................................................................... 1,621 ........................ 2,418 .......................... 2,186 

* Average. 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 7–1044, One Choke Cherry Road, 

Rockville, MD 20857 and e-mail her a 

copy at summer.king@samhsa.hhs.gov. 

Written comments should be received 

within 60 days of this notice. 

Dated: October 8, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–24940 Filed 10–15–09; 8:45 am] 

BILLING CODE 4162–20–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. 

B-cell Surface Reactive Antibodies for 

the Treatment of B–Cell Chronic 

Lymphocytic Leukemia 

Description of Technology: B-cell 

chronic lymphocytic leukemia (B–CLL) 

is a cancer characterized by a 

progressive accumulation of 

functionally incompetent lymphocytes. 

Despite high morbidity and mortality, 

the only available potential cure is 

allogeneic hematopoietic stem cell 

transplantation (alloHSCST). However, 

there is less than a 50% chance of 

finding a matching bone marrow or 

blood donor for B–CLL patients. Other 

clinically tested targeted therapies such 

as rituximab and alemtuzumab target 

both malignant and normal B cells, 

resulting in immunosuppression. 

Available for licensing are fully 

human monoclonal antibodies that were 

selected from the first human postalloHSCT antibody library. The library 

was generated from a time point after 

transplantation at which antibodies to 

B–CLL cell surface antigens peaked, 

thus indicating its therapeutic value. 

Utilizing phage display, the 

investigators generated a panel of fully 

human monoclonal antibodies that 

strongly bind to the same epitope on a 

B–CLL cell surface antigen. Weaker 

binding to normal B cells, but not to 

other lymphocytes, was observed. These 

fully human monoclonal antibodies 

provide readily available treatment that 

selectively targets malignant B cells. 

Applications: 

• B-cell chronic lymphocytic 

leukemia therapeutics. 

• Method to inhibit the growth of 

malignant B-cells. 

• Method to detect B-cell tumors. 

Advantages: 

• Selective targeting of malignant Bcell surface antigens that are minimally 

non-damaging to non-diseased cells. 

• Readily available therapeutics 

without the need for bone marrow or 

blood transplantation. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Market: 

• Monoclonal antibody market has 

the potential to reach $30.3 billion in 

2010 largely driven by technological 

evolution from chimeric and humanized 

to fully human antibodies. 

• In the U.S., there is annual 

incidence of an estimated 15,000 newly 

diagnosed cases of B–CLL and the 

disease is responsible for an estimated 

4,500 deaths. 

Inventors: Christoph Rader et al. (NCI) 

Publication: S Baskar, JM Suschak, I 

Samija, R Srinivasan, RW Childs, SZ 

Pavletic, MR Bishop, C Rader. A human 

monoclonal antibody drug and target 

discovery platform for B-cell chronic 

lymphocytic leukemia based on 

allogeneic hematopoietic stem cell 

transplantation and phage display. 

Blood, in press. Epub ahead of print, 

2009 Aug 10. 

Patent Status: U.S. Provisional 

Application No. 61/178,688 filed 15 

May 2009 (HHS Reference No. E–163– 

2009/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jennifer Wong; 

301–435–4633; wongje@mail.nih.gov. 

Collaborative Research Opportunity: 

The Center for Cancer Research, 

Experimental Transplantation and 

Immunology Branch, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize fully human monoclonal 

antibodies selected from post-alloHSCT 

antibody libraries. Please contact John 

D. Hewes, Ph.D. at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

CXCR4 and CCR10 Expressing Cells: 

Useful for the Study of Cancer Cell 

Survival and Metastasis 

Description of Technology: The 

chemokine receptor CXCR4 functions in 

normal cells, but has been shown to be 

the most common chemokine receptor 

expressed on cancer cells, including 

melanoma, colon, breast, and lung 

cancers. It plays roles in angiogenesis 

and cancer cell survival as well as 

metastasis. CCR10 has also been shown 

to be expressed by melanoma cells. Like 

CXCR4, expression of CCR10 can 

enhance cancer cell survival and block 

immune recognition of cancer cells. 

Antagonists of CXCR4 and CCR10, 

under various conditions, have 

decreased metastasis or prevented 

tumor formation after implantation of 

cancer cells in mice. 

These cell lines are based on the 

widely used B16 murine melanoma cell 

line. The cell lines were transduced 

with retroviral vectors encoding cDNA 

for either CXCR4 or CCR10 under 

control of a TET-dependent promoter. 

Both lines achieve greater than 10 fold 

induction of the respective genes 

(proteins), which has been confirmed by 

surface antibody staining using flow 

cytometry. These cell lines are ideally 

suited for studying the effect of these 

chemokine receptors in tumor growth or 

metastasis. They are also useful for 


jlentini on DSKJ8SOYB1PROD with NOTICES