Agency Information Collection Activities: Proposed Collection; Comment Request, 53262-53264 [E9-24940]
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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
Number of
respondents
Forms and respondents
Screener ......................................................................................................................................
Survey: General Population .........................................................................................................
Survey: Elderly .............................................................................................................................
Survey: Low SES .........................................................................................................................
Survey: Low SES African American ............................................................................................
Survey: Hispanic ..........................................................................................................................
Survey: Chinese ..........................................................................................................................
Survey: Vietnamese .....................................................................................................................
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
jlentini on DSKJ8SOYB1PROD with NOTICES
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]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Substance Abuse and Mental Health
Services Administration
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
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19,250
1,000
275
275
150
75
75
75
Number of responses per
respondent
1
1
1
1
1
1
1
1
Average
burden per
response
(in hours)
2/60
18/60
18/60
18/60
18/60
18/60
18/60
18/60
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
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53263
Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices
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
Responses
per
respondent
Number of
respondents
42 CFR Citation and purpose
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.
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) .....
54.8(c)(4) Total number of referrals to alternative
service providers reported by program participants
to States (respondents).
SAPT BG .............................................................
PATH ...................................................................
54.8(e) Annual report by PATH grantees on activities
undertaken to comply with 42 CFR Part 54
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 .............................................................
PATH ...................................................................
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
Part 54—Subtotal ................................................
60
1
60
1
60
7
0
*68
5
476
50
1
1
476
50
56
1
56
1
56
60
56
1
1
60
56
60
1
60
116
........................
818
.05
.05
1
..........................
3
3
60
708
jlentini on DSKJ8SOYB1PROD with NOTICES
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 ..................................................
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.) .......
Disclosure:
54a.8(b) Program participant notice to program
beneficiaries of rights to referral to an alternative
service provider .......................................................
Part 54a—Subtotal ..............................................
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25
4
100
.083
8
20
2
40
.25
10
1,460
1
1,460
1,505
........................
1,600
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1
..........................
16OCN1
1,460
1,478
53264
Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices
Responses
per
respondent
Number of
respondents
42 CFR Citation and purpose
Total .....................................................................
1,621
........................
Total
responses
2,418
Hours per
response
..........................
Total hours
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.
jlentini on DSKJ8SOYB1PROD with NOTICES
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
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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
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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
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]]>Agencies
[Federal Register Volume 74, Number 199 (Friday, October 16, 2009)]
[Notices]
[Pages 53262-53264]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24940]
-----------------------------------------------------------------------
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
[[Page 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.
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per
42 CFR Citation and purpose respondents respondent responses 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 60 1 60 1 60
of activities the State
undertook to comply 42 CFR
Part 54 (SAPT BG)..........
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 56 1 56 1 56
PATH grantees on activities
undertaken to comply with
42 CFR Part 54
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 60 1 60 1 60
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
-------------------------------------------------------------------------------
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 25 4 100 .083 8
of referrals to alternative
service providers reported
by program participants to
States when they are the
responsible unit of
government.................
54a(8)(d) Total number of 20 2 40 .25 10
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.)........
Disclosure:
54a.8(b) Program participant 1,460 1 1,460 1 1,460
notice to program
beneficiaries of rights to
referral to an alternative
service provider...........
-------------------------------------------------------------------------------
Part 54a--Subtotal...... 1,505 .............. 1,600 .............. 1,478
-------------------------------------------------------------------------------
[[Page 53264]]
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
