Agency Information Collection Activities: Proposed Collection; Comment Request, 57029-57033 [2010-23207]
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Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices
includes an optional GHS hazard
category that could be used to provide
at least equivalent hazard labeling as
current U.S. regulations in order to
support continued protection of
consumers and workers.
The ICCVAM TMER, Current
Validation Status of a Proposed In Vitro
Testing Strategy for U.S. Environmental
Protection Agency Ocular Hazard
Classification and Labeling of
Antimicrobial Cleaning Products (NIH
Publication No. 10–7513) provides
ICCVAM’s evaluation and
recommendations regarding the use of a
proposed in vitro testing strategy to
classify and label AMCPs for eye
irritation. ICCVAM concludes that the
data are insufficient to adequately
demonstrate that the proposed in vitro
testing strategy can classify test
substances to all four EPA ocular hazard
categories. ICCVAM recommends
further studies to characterize the
usefulness and limitations of the nonanimal in vitro testing strategy that uses
the three in vitro test methods. This
report also includes updated ICCVAMrecommended BCOP, CM, and
EpiOcular TM test method protocols, the
final summary review document (SRD),
and the panel’s peer review report.
The ICCVAM TMER,
Recommendation to Discontinue Use of
the Low Volume Eye Test for Ocular
Safety Testing (NIH Publication No. 10–
7515) provides ICCVAM’s evaluation
and recommendations on the usefulness
of the LVET as an in vivo reference test
method. ICCVAM concludes that the
proposed LVET should not be used for
regulatory safety testing due to
performance issues.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Background Information on ICCVAM,
NICEATM, and SACATM
ICCVAM is an interagency committee
composed of representatives from 15
Federal regulatory and research agencies
that require, use, or generate
toxicological and safety testing
information for chemicals, products,
and other substances. ICCVAM
conducts technical evaluations of new,
revised, and alternative methods with
regulatory applicability, and promotes
the scientific validation and regulatory
acceptance of toxicological and safety
testing methods that more accurately
assess the safety and health hazards of
chemicals and products while reducing,
refining (decreasing or eliminating pain
and distress), or replacing animal use.
The ICCVAM Authorization Act of 2000
(42 U.S.C. 285l–2, 285l–5 [2000],
available at https://iccvam.niehs.nih.gov/
docs/about_docs/PL106545.pdf)
established ICCVAM as a permanent
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interagency committee of the NIEHS
under NICEATM.
NICEATM administers ICCVAM,
provides scientific and operational
support for ICCVAM-related activities,
and coordinates international validation
studies of new and improved test
methods. NICEATM and ICCVAM work
collaboratively to evaluate new and
improved test methods applicable to the
needs of U.S. Federal agencies.
NICEATM and ICCVAM welcome the
public nomination of new, revised, and
alternative test methods for validation
studies as well as technical evaluations.
Additional information about NICEATM
and ICCVAM can be found on the
NICEATM–ICCVAM Web site (https://
www.iccvam.niehs.nih.gov).
SACATM was established January 9,
2002, and is composed of scientists from
the public and private sectors (67 FR
11358). SACATM provides advice to the
Director of the NIEHS, ICCVAM, and
NICEATM regarding the statutorily
mandated duties of ICCVAM and
activities of NICEATM. Additional
information about SACATM, including
the charter, roster, and records of past
meetings, can be found at https://
ntp.niehs.nih.gov/go/167.
References
ICCVAM. 2006. ICCVAM Test Method
Evaluation Report: In Vitro Ocular
Toxicity Test Methods for
Identifying Severe Irritants and
Corrosives. NIH Publication No. 07–
4517. Research Triangle Park, NC:
NIEHS. Available: https://
iccvam.niehs.nih.gov/methods/
ocutox/ivocutox/ocu_tmer.htm.
ICCVAM. 2010. ICCVAM Test Method
Evaluation Report:
Recommendations for Routine Use
of Topical Anesthetics, Systemic
Analgesics, and Humane Endpoints
to Avoid or Minimize Pain and
Distress in Ocular Safety Testing.
NIH Publication No. 10–7514.
Research Triangle Park, NC: NIEHS.
Available: https://
iccvam.niehs.nih.gov/methods/
ocutox/OcuAnest-TMER.htm.
ICCVAM. 2010. ICCVAM Test Method
Evaluation Report: Current
Validation Status of In Vitro Test
Methods Proposed for Identifying
Eye Injury Hazard Potential of
Chemicals and Products. NIH
Publication No. 10–7553. Research
Triangle Park, NC: NIEHS.
Available: https://
iccvam.niehs.nih.gov/methods/
ocutox/MildMod-TMER.htm.
ICCVAM. 2010. ICCVAM Test Method
Evaluation Report: Current
Validation Status of a Proposed In
Vitro Testing Strategy for U.S.
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Environmental Protection Agency
Ocular Hazard Classification and
Labeling of Antimicrobial Cleaning
Products. NIH Publication No. 10–
7513. Research Triangle Park, NC:
NIEHS. Available: https://
iccvam.niehs.nih.gov/methods/
ocutox/AMCP–TMER.htm.
ICCVAM. 2010. ICCVAM Test Method
Evaluation Report:
Recommendation to Discontinue
Use of The Low Volume Eye Test
for Ocular Safety Testing. NIH
Publication No. 10–7515. Research
Triangle Park, NC: NIEHS.
Available: https://
iccvam.niehs.nih.gov/methods/
ocutox/LVET.htm.
Dated: September 10, 2010.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2010–23262 Filed 9–16–10; 8:45 am]
BILLING CODE 4140–01–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
respondents, including through the use
of automated collection techniques or
other forms of information technology.
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Proposed Project: Strategic Prevention
Framework State Incentive Grant (SPF
SIG) Program (OMB No. 0930–0279)—
Revision
SAMHSA’s Center for Substance
Abuse Prevention (CSAP) is responsible
for the evaluation instruments of the
Strategic Prevention Framework State
Incentive Grant (SPF SIG) Program. The
program is a major initiative designed
to: (1) Prevent the onset and reduce the
progression of substance abuse,
including childhood and underage
drinking; (2) reduce substance abuse
related problems; and, (3) build
prevention capacity and infrastructure
at the State-, territorial-, tribal- and
community-levels.
Five steps comprise the SPF:
Step 1: Profile population needs,
resources, and readiness to address the
problems and gaps in service delivery.
Step 2: Mobilize and/or build capacity
to address needs.
Step 3: Develop a comprehensive
strategic plan.
Step 4: Implement evidence-based
prevention programs, policies, and
practices and infrastructure
development activities.
Step 5: Monitor process, evaluate
effectiveness, sustain effective
programs/activities, and improve or
replace those that fail.
An evaluation team is currently
implementing a multi-method, quasiexperimental evaluation of the first two
Strategic Prevention Framework State
Incentive Grant (SPF SIG) cohorts
receiving grants in FY 2004 and FY
2005. This notice invites comments for
revision to the protocol for the ongoing
cross-site evaluation for the Strategic
Prevention Framework State Incentive
Grant (SPF SIG) (OMB No. 0930–0279)
which expires on 11/30/12. This
revision includes two parts:
(1) Continuation of the use of the
previously approved two-part
Community Level Instrument (CLI Parts
I and II) for Cohorts I and II and the use
of an instrument to assess the
sustainability of grantee implementation
and infrastructure accomplishments
which is a modification of an
instrument used in an earlier phase of
the evaluation.
(2) The use of three additional
instruments to support the SPF SIG
Cohorts III and IV Cross-site Evaluation.
All three instruments are modified
versions of data collection protocols
used by Cohorts I and II. The three
instruments are:
a. A Grantee-Level SPF
Implementation Instrument,
b. A Grantee-Level Infrastructure
Instrument, and
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c. A two-part Community-Level SPF
Implementation Instrument.
An additional Cohort III and IV
evaluation component (i.e., participantlevel NOMs outcomes) is also included
in this submission as part of the
comprehensive evaluation, however, no
associated burden from this evaluation
activity is being imposed and therefore
clearance to conduct the activities is not
being requested. Specifically, Cohort III
and IV SPF SIG grantees have been
included in the currently OMB
approved umbrella NOMs application
(OMB No. 0930–0230) covering the
collection of participant-level NOMs
outcomes by all SAMHSA/CSAP
grantees.
Every attempt has been made to make
the evaluation for Cohorts III and IV
comparable to Cohorts I and II.
However, resource constraints for the
Cohorts III and IV evaluation have
necessitated some streamlining of the
original evaluation design. Since the
ultimate goal is to fund all eligible
jurisdictions, there are no control
groups at the grantee level for Cohorts
III and IV. The primary evaluation
objective is to determine the impact of
SPF SIG on the reduction of substance
abuse related problems, on building
state prevention capacity and
infrastructure, and preventing the onset
and reducing the progression of
substance abuse, as measured by the
SAMHSA National Outcomes Measures
(NOMs). Data collected at the grantee,
community, and participant levels will
provide information about process and
system outcomes at the grantee and
community levels as well as context for
analyzing participant-level NOMS
outcomes. The Grantee-Level
Infrastructure and Implementation
Instruments (Cohorts III and IV) and the
Community-Level Part I and Part II
(Cohorts I, II, III, and IV) Instruments are
included in an OMB review package
and are the main focus of this
announcement.
Grantee-Level Data Collection
Cohort I and II Continuation
The Sustainability Interview will be
conducted during Phase II of the
evaluation in 2011 (Cohort I) and 2012
(Cohort II). The interview guide is
adapted from the Phase I instruments
(OMB No. 0930–0279) and focuses on
state-level prevention capacity and
infrastructure in relation to the five
steps of the SPF process: Needs
assessment, capacity building, strategic
planning, implementation of evidencebased programs, policies, and practices
(EBPPPs), and evaluation/monitoring.
The interviews will be aimed at
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understanding the status of the
prevention infrastructure at the time of
the interview, whether the status has
changed since the previous rounds of
interviews (conducted in 2007 and
2009), and whether the SPF SIG had any
influence on changes that might have
occurred.
Cohort III and IV Revision
Two Grantee-level Instruments (GLI)
were developed to gather information
about the infrastructure of the grantee’s
overall prevention system and collect
data regarding the grantee’s efforts and
progress in implementing the Strategic
Prevention Framework 5-step process.
Both instruments are modified versions
of the grantee-level interview protocols
used in the SPF SIG Cohort I and II
Cross-Site Evaluation (OMB No. 0930–
0279). The total burden imposed by the
original interview protocols has been
reduced by restructuring the format of
the original protocol, deleting several
questions and replacing the majority of
open-ended questions with multiplechoice-response questions. The
Infrastructure Instrument will capture
data to assess infrastructure change and
to test the relationship of this change to
outcomes. The Strategic Prevention
Framework Implementation Instrument
will be used to assess the relationship
between SPF implementation and
change in the NOMs. Information for
both surveys will be gathered by the
grantees’ evaluators twice over the life
of the SPF SIG award.
Based on the current 16 grantees
funded in Cohort III and an estimated 20
to be funded in Cohort IV the estimated
annual burden for grantee-level data
collection is displayed below in Table 1.
The burden estimates for the GLIs are
based on the experience in the Cohort
I and II SPF SIG evaluation as reported
in the original OMB submission (OMB
No. 0930–0279), less the considerable
reduction in length of these instruments
implemented by the Cohort III and IV
evaluation team.
Community-Level Data Collection
(Continuation and Revision)
Cohort I and II Continuation
The Community-level Instrument
(CLI) is a two part, web-based survey for
capturing information about SPF SIG
implementation at the community level
(originally submitted as an addendum to
OMB No. 0930–0279). Part I of this
instrument was developed to assess the
progress of communities as they
implement the Strategic Prevention
Framework (SPF), and Part II was
developed to gather descriptive
information about the specific
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Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices
interventions being implemented at the
community level and the populations
being served including the gender, age,
race, ethnicity, and number of
individuals in target populations. Each
SPF SIG funded community will
complete a separate Part II form for each
intervention they implement.
The CLI (Parts I and II) was designed
to be administered two times a year
(every six months) over the course of the
SPF SIG Cohort I and II initiative. Four
rounds of data were collected under the
current OMB approval period and the
Cohorts I and II cross-site evaluation
team plans to collect additional rounds
once this request for a revision is
approved. Data from this instrument
will allow CSAP to assess the progress
of the communities in their
implementation of both the SPF and
prevention-related interventions funded
under the initiative. The data may also
be used to assess obstacles to the
implementation of the SPF and
prevention-related interventions and
facilitate mid-course corrections for
communities experiencing
implementation difficulties.
The estimated annual burden for
community-level data collection is
displayed below in Table 1. Note that
the total burden reflects the 443
communities that have received SPF
funds from their respective Cohort I and
Cohort 2 States. Burden estimates are
based on pilot respondents’ feedback as
well as the experience of the survey
developers reported in the original OMB
submission (OMB No. 0930–0279).
Additionally, an individual
community’s burden may be lower than
the burden displayed in Table 1 because
all sections of the Community-level
Instrument (parts I and II) may not
apply for each reporting period as
community partners work through the
SPF steps and only report on the steprelated activities addressed. Note also
that some questions will be addressed
only once and the responses will be
used to pre-fill subsequent surveys.
Cohort III and IV (Revision)
The Community-Level Instrument to
be completed by Cohort III and IV
funded subrecipient communities is a
modified version of the one in use in the
SPF SIG Cohorts I and II Cross-Site
Evaluation (OMB No. 0930–0279). The
total burden imposed by the original
instrument was reduced by reorganizing
the format of the original instrument,
optimizing the use of skip patterns, and
replacing the majority of open-ended
questions with multiple-choiceresponse questions.
Part I of the instrument will gather
information on the communities’
progress implementing the five SPF SIG
steps and efforts taken to ensure cultural
competency throughout the SPF SIG
process. Subrecipient communities
receiving SPF SIG awards will be
required to complete Part I of the
instrument annually. Part 2 will capture
data on the specific prevention
intervention(s) implemented at the
community level. A single prevention
intervention may be comprised of a
single strategy or a set of multiple
strategies. A Part II instrument will be
completed for each prevention
intervention strategy implemented
during the specified reporting period.
Specific questions will be tailored to
match the type of prevention
intervention strategy implemented (e.g.,
Prevention Education, Communitybased Processes, and Environmental).
Information collected on each strategy
will include date of implementation,
numbers of groups and participants
served, frequency of activities, and
gender, age, race, and ethnicity of
population served/affected.
Subrecipient communities’ partners
receiving SPF SIG awards will be
required to update Part II of the
instrument a minimum of every six
months.
The estimated annual burden for
specific segments of the communitylevel data collection is displayed in
Table 1. The burden estimates for the
CLIs are based on the experience in the
Cohort I and II SPF SIG evaluation as
reported in the original OMB
submission (OMB No. 0930–0279), less
the considerable reduction in length of
these instruments implemented by the
Cohort III and IV evaluation team. The
total burden assumes an average of 15
community-level subrecipients per
grantee (n=36 Grantees) for a total of 540
community respondents, annual
completion of the CLI Part I, a minimum
of two instrument updates per year for
the CLI Part II, and an average of three
distinct prevention intervention
strategies implemented by each
community during a 6-month period.
Additionally, some questions will be
addressed only once and the responses
will be used to pre-fill subsequent
updates.
Participant-Level Data Collection
(Cohort III and IV—Continuation)
Participant-level change will be
measured using the CSAP NOMs Adult
and Youth Programs Survey Forms
already approved by OMB (OMB No.
0930–0230). Subrecipient communities
will have the opportunity to select
relevant measures from the CSAP NOMs
Adult and Youth Programs Survey
Forms based on site-specific targeted
program outcomes and may voluntarily
select additional outcome measures that
are relevant to their own initiatives.
Cohort III and IV SPF SIG grantees have
been included in the currently OMB
approved umbrella NOMs application
(OMB No. 0930–0230) covering all
SAMHSA/CSAP grantees, therefore no
additional burden for this evaluation
activity is being imposed and clearance
to conduct the activities is not being
requested.
Total Estimates of Annualized Hour
Burden
Estimates of total and annualized
reporting burden for respondents by
evaluation cohort are displayed below
in Table 1. Overall summaries appear in
Table 2. The estimated average annual
burden of 5,642.9 hours is based on the
completion of the Community LevelInstrument (CLI Parts I and II) and
Sustainability Interview for Cohorts I
and II, and the Grantee-level
Instruments (GLI) and the CommunityLevel Instrument (CLI) for Cohorts III
and IV.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
TABLE 1—ESTIMATES OF ANNUALIZED HOUR BURDEN TO RESPONDENTS
Instrument
Respondent
Number of
respondents
Number of
responses per
respondent
(over four
years)
Total number
of responses
(over four
years)
Burden per
response
(hrs.)
Total burden
(hrs.)
Cohorts 1 and 2—Grantee Level Burden
CLI grantee input .....................................
Sustainability Interview ............................
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Grantee
Grantee
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26
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1
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26
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1.5
52.0
39.0
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TABLE 1—ESTIMATES OF ANNUALIZED HOUR BURDEN TO RESPONDENTS—Continued
Instrument
Respondent
Number of
responses per
respondent
(over four
years)
Number of
respondents
Total number
of responses
(over four
years)
Burden per
response
(hrs.)
Total burden
(hrs.)
Total Burden .....................................
Grantee
26
3
78
2.5
91.0
Average Annual Burden Over 4
Reporting years ......................
Grantee
26
........................
........................
........................
22.8
Cohorts 1 and 2—Community Level Burden
CLI Part 1 .................................................
CLI Part 2 .................................................
Review of Past Responses ......................
Community
Community
Community
443
443
443
2
8
2
886
3,544
886
2.17
2.17
2.50
1,922.6
7,690.5
2,215.0
Total Burden .....................................
Community
443
12
5,316
6.84
11,828.1
Average Annual Burden Over 4
Reporting years ......................
Community
443
........................
........................
........................
2,957.0
Cohorts 3 and 4—Grantee Level Burden
GLI Infrastructure & Implementation Instruments (Reporting Years 1–4) .........
CLI Part I, 1–20: Community Contact Information (Reporting Year 1) ...............
CLI Part I, 1–20: Community Contact Information (Reporting Years 2–4) ..........
Grantee
36
2
72
4.75
342.0
Grantee
36
1
36
1.5
54.0
Grantee
36
3
108
0.25
27.0
Total Burden Over 4 Reporting
Years .............................................
Grantee
36
6
216
6.5
423.0
Average Annual Burden ............
Grantee
9
........................
........................
........................
105.8
Cohorts 3 and 4—Community Level Burden
CLI Part I, 21–172: Community SPF Activities (Reporting Year 1) ....................
CLI Part II (Reporting Year 1) .................
CLI Part I, 21–172: Community SPF Activities (Reporting Years 2–4) ...............
CLI Part II (Reporting Years 2–4) ............
Community
Community
540
540
1
6
540
3,240
3
0.75
1,620.0
2,430.0
Community
Community
540
540
3
18
1,620
9,270
0.75
0.5
1,215.0
4,860.0
Total Burden Over 4 Years ..............
Community
540
28
15,120
5
10,125.0
Average Annual Burden ............
Community
540
........................
........................
........................
2,531.3
TABLE 2—ANNUALIZED SUMMARY TABLE
Number of
respondents
Respondents
Responses/
respondent
Total
responses
Total
annualized
hour burden
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
All Cohorts—Total Burden
Cohort 1 and 2:
Grantees ...................................................................................................
Community ................................................................................................
Cohort 3 and 4:
Grantees ...................................................................................................
Community ................................................................................................
Sub-total Grantees ............................................................................
Sub-total Community .........................................................................
Total ...........................................................................................
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26
443
3
12
78
5,316
48.8
2,957.0
36
540
62
983
1045
6
28
........................
........................
........................
216
15,120
........................
........................
20,730
105.8
2,531.3
128.6
5,488.3
5,616.9
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Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 7–1044, One Choke Cherry Road,
Rockville, MD 20857 and e-mail a copy
to summer.king@samhsa.hhs.gov.
Written comments should be received
within 60 days of this notice.
Dated: September 10, 2010.
Elaine Parry,
Director, Office of Management, Technology
and Operations.
[FR Doc. 2010–23207 Filed 9–16–10; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘Evaluation of the National Guideline
Clearinghouse.’’ In accordance with the
Paperwork Reduction Act, 44 U.S.C.
3501–3520, AHRQ invites the public to
comment on this proposed information
collection.
DATES: Comments on this notice must be
received by November 16, 2010.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHIRQ, by email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at
doris.lefkowitz@AHRO.hhs.gov.
SUPPLEMENTARY INFORMATION:
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
SUMMARY:
Proposed Project
Evaluation of the National Guideline
Clearinghouse
The mission of the Agency for
Healthcare Research and Quality
(AHRQ) is to enhance the quality,
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appropriateness, and effectiveness of
Health services, and access to such
services, through the establishment of a
broad base of scientific research and
through the promotion of improvements
in clinical and health system practices,
including the prevention of diseases and
other health conditions. 42 U.S.C.
299(b). AHRQ supports the
dissemination of evidence-based
guidelines through its National
Guideline ClearinghouseTM (NGC).
The NGC serves as a publicly
accessible Web-based database of
evidence-based clinical practice
guidelines meeting explicit criteria. The
NGC also supports AHRQ’s strategic
goal on effectiveness: to improve health
care outcomes by encouraging the use of
evidence to make informed health care
decisions. The NGC is a vehicle for such
encouragement. The mission of the NGC
is to provide physicians, nurses, and
other health professionals, health care
providers, health plans, integrated
delivery systems, purchasers and others
an accessible mechanism for obtaining
objective, detailed information on
clinical practice guidelines and to
further their dissemination,
implementation and use.
AHRQ proposes to conduct a
comprehensive evaluation of the NGC.
This evaluation will build on the site
trends AHIRQ has already identified,
including growth from 70,000 to
700,000 visits per month, 600 to
approximately 40,000 e-mail
subscribers, 250 to 2,370 guidelines
represented, and 50 to nearly 300
participating guideline developer
organizations from July 1999 to July
2009.
The objectives of the NGC evaluation
are to gain a better understanding of
how:
• The NGC is used.
• The NGC supports dissemination of
evidence-based clinical practice
guidelines and related documents.
• The NGC has influenced efforts in
guideline development and guideline
implementation and use.
• The NGC can be improved.
This study is being conducted by
AHRQ through its contractor, AFYA,
Inc. and The Lewin Group (AFYA/
Lewin), pursuant to AJ4RQ’s statutory
authority to conduct and support
research and disseminate information
on healthcare and on systems for the
delivery of such care, including
activities with respect to clinical
practice. 42 U.S.C. 299a(a)(4).
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
57033
Method of Collection
To achieve the objectives of this
project the following data collections
will be implemented:
(1) NGC evaluation survey—a webbased survey administered to a
convenience sample of both users and
non-users of the NGC,
(2) Focus groups—conducted with
guideline developers, medical
librarians, informatics specialists,
clinicians, and students, and
(3) Key informant interviews—inperson interviews conducted with
influential individuals in medical
societies, health plans, and quality
improvement organizations as well as
medical librarians, researchers, and
informatics specialists who produce,
use, and disseminate guidelines.
Questions in the survey, focus group,
and key informant discussion guides
will focus on the effectiveness of NGC
in areas of dissemination,
implementation, and use of evidencebased clinical practice guidelines, and
relative to other available guideline
sources. For example, measures to be
gathered through the instruments
include the level of trust of the NGC, the
use of the NGC relative to other
guideline sources, and the influence of
the NGC on various stakeholder groups.
In addition, the instruments will be
used to measure the use of other
guideline resources which are used by
non-NGC users.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
evaluation. The NGC evaluation
questionnaire will be completed by
approximately 40,220 persons and will
require 10 minutes to complete for users
of the NGC and about 2 minutes for nonusers. For the purpose of calculating
respondent burden an average of 8
minutes is used and reflects a mix of
users and non-users with most
respondents expected to be users.
Eleven different focus groups
consisting of 9 persons each will be
conducted and are expected to last 90
minutes each. Key informant interviews
will be conducted with 30 individuals
and will last about 60 minutes. The total
annual burden hours are estimated to be
5,542 hours.
Exhibit 2 shows the estimated
annualized cost burden based on the
respondents’ time to participate in this
project. The total annual cost burden is
estimated to be $185,712.
E:\FR\FM\17SEN1.SGM
17SEN1
]]>Agencies
[Federal Register Volume 75, Number 180 (Friday, September 17, 2010)]
[Notices]
[Pages 57029-57033]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23207]
-----------------------------------------------------------------------
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 respondents,
including through the use of automated collection techniques or other
forms of information technology.
[[Page 57030]]
Proposed Project: Strategic Prevention Framework State Incentive Grant
(SPF SIG) Program (OMB No. 0930-0279)--Revision
SAMHSA's Center for Substance Abuse Prevention (CSAP) is
responsible for the evaluation instruments of the Strategic Prevention
Framework State Incentive Grant (SPF SIG) Program. The program is a
major initiative designed to: (1) Prevent the onset and reduce the
progression of substance abuse, including childhood and underage
drinking; (2) reduce substance abuse related problems; and, (3) build
prevention capacity and infrastructure at the State-, territorial-,
tribal- and community-levels.
Five steps comprise the SPF:
Step 1: Profile population needs, resources, and readiness to
address the problems and gaps in service delivery.
Step 2: Mobilize and/or build capacity to address needs.
Step 3: Develop a comprehensive strategic plan.
Step 4: Implement evidence-based prevention programs, policies, and
practices and infrastructure development activities.
Step 5: Monitor process, evaluate effectiveness, sustain effective
programs/activities, and improve or replace those that fail.
An evaluation team is currently implementing a multi-method, quasi-
experimental evaluation of the first two Strategic Prevention Framework
State Incentive Grant (SPF SIG) cohorts receiving grants in FY 2004 and
FY 2005. This notice invites comments for revision to the protocol for
the ongoing cross-site evaluation for the Strategic Prevention
Framework State Incentive Grant (SPF SIG) (OMB No. 0930-0279) which
expires on 11/30/12. This revision includes two parts:
(1) Continuation of the use of the previously approved two-part
Community Level Instrument (CLI Parts I and II) for Cohorts I and II
and the use of an instrument to assess the sustainability of grantee
implementation and infrastructure accomplishments which is a
modification of an instrument used in an earlier phase of the
evaluation.
(2) The use of three additional instruments to support the SPF SIG
Cohorts III and IV Cross-site Evaluation. All three instruments are
modified versions of data collection protocols used by Cohorts I and
II. The three instruments are:
a. A Grantee-Level SPF Implementation Instrument,
b. A Grantee-Level Infrastructure Instrument, and
c. A two-part Community-Level SPF Implementation Instrument.
An additional Cohort III and IV evaluation component (i.e.,
participant-level NOMs outcomes) is also included in this submission as
part of the comprehensive evaluation, however, no associated burden
from this evaluation activity is being imposed and therefore clearance
to conduct the activities is not being requested. Specifically, Cohort
III and IV SPF SIG grantees have been included in the currently OMB
approved umbrella NOMs application (OMB No. 0930-0230) covering the
collection of participant-level NOMs outcomes by all SAMHSA/CSAP
grantees.
Every attempt has been made to make the evaluation for Cohorts III
and IV comparable to Cohorts I and II. However, resource constraints
for the Cohorts III and IV evaluation have necessitated some
streamlining of the original evaluation design. Since the ultimate goal
is to fund all eligible jurisdictions, there are no control groups at
the grantee level for Cohorts III and IV. The primary evaluation
objective is to determine the impact of SPF SIG on the reduction of
substance abuse related problems, on building state prevention capacity
and infrastructure, and preventing the onset and reducing the
progression of substance abuse, as measured by the SAMHSA National
Outcomes Measures (NOMs). Data collected at the grantee, community, and
participant levels will provide information about process and system
outcomes at the grantee and community levels as well as context for
analyzing participant-level NOMS outcomes. The Grantee-Level
Infrastructure and Implementation Instruments (Cohorts III and IV) and
the Community-Level Part I and Part II (Cohorts I, II, III, and IV)
Instruments are included in an OMB review package and are the main
focus of this announcement.
Grantee-Level Data Collection
Cohort I and II Continuation
The Sustainability Interview will be conducted during Phase II of
the evaluation in 2011 (Cohort I) and 2012 (Cohort II). The interview
guide is adapted from the Phase I instruments (OMB No. 0930-0279) and
focuses on state-level prevention capacity and infrastructure in
relation to the five steps of the SPF process: Needs assessment,
capacity building, strategic planning, implementation of evidence-based
programs, policies, and practices (EBPPPs), and evaluation/monitoring.
The interviews will be aimed at understanding the status of the
prevention infrastructure at the time of the interview, whether the
status has changed since the previous rounds of interviews (conducted
in 2007 and 2009), and whether the SPF SIG had any influence on changes
that might have occurred.
Cohort III and IV Revision
Two Grantee-level Instruments (GLI) were developed to gather
information about the infrastructure of the grantee's overall
prevention system and collect data regarding the grantee's efforts and
progress in implementing the Strategic Prevention Framework 5-step
process. Both instruments are modified versions of the grantee-level
interview protocols used in the SPF SIG Cohort I and II Cross-Site
Evaluation (OMB No. 0930-0279). The total burden imposed by the
original interview protocols has been reduced by restructuring the
format of the original protocol, deleting several questions and
replacing the majority of open-ended questions with multiple-choice-
response questions. The Infrastructure Instrument will capture data to
assess infrastructure change and to test the relationship of this
change to outcomes. The Strategic Prevention Framework Implementation
Instrument will be used to assess the relationship between SPF
implementation and change in the NOMs. Information for both surveys
will be gathered by the grantees' evaluators twice over the life of the
SPF SIG award.
Based on the current 16 grantees funded in Cohort III and an
estimated 20 to be funded in Cohort IV the estimated annual burden for
grantee-level data collection is displayed below in Table 1. The burden
estimates for the GLIs are based on the experience in the Cohort I and
II SPF SIG evaluation as reported in the original OMB submission (OMB
No. 0930-0279), less the considerable reduction in length of these
instruments implemented by the Cohort III and IV evaluation team.
Community-Level Data Collection (Continuation and Revision)
Cohort I and II Continuation
The Community-level Instrument (CLI) is a two part, web-based
survey for capturing information about SPF SIG implementation at the
community level (originally submitted as an addendum to OMB No. 0930-
0279). Part I of this instrument was developed to assess the progress
of communities as they implement the Strategic Prevention Framework
(SPF), and Part II was developed to gather descriptive information
about the specific
[[Page 57031]]
interventions being implemented at the community level and the
populations being served including the gender, age, race, ethnicity,
and number of individuals in target populations. Each SPF SIG funded
community will complete a separate Part II form for each intervention
they implement.
The CLI (Parts I and II) was designed to be administered two times
a year (every six months) over the course of the SPF SIG Cohort I and
II initiative. Four rounds of data were collected under the current OMB
approval period and the Cohorts I and II cross-site evaluation team
plans to collect additional rounds once this request for a revision is
approved. Data from this instrument will allow CSAP to assess the
progress of the communities in their implementation of both the SPF and
prevention-related interventions funded under the initiative. The data
may also be used to assess obstacles to the implementation of the SPF
and prevention-related interventions and facilitate mid-course
corrections for communities experiencing implementation difficulties.
The estimated annual burden for community-level data collection is
displayed below in Table 1. Note that the total burden reflects the 443
communities that have received SPF funds from their respective Cohort I
and Cohort 2 States. Burden estimates are based on pilot respondents'
feedback as well as the experience of the survey developers reported in
the original OMB submission (OMB No. 0930-0279). Additionally, an
individual community's burden may be lower than the burden displayed in
Table 1 because all sections of the Community-level Instrument (parts I
and II) may not apply for each reporting period as community partners
work through the SPF steps and only report on the step-related
activities addressed. Note also that some questions will be addressed
only once and the responses will be used to pre-fill subsequent
surveys.
Cohort III and IV (Revision)
The Community-Level Instrument to be completed by Cohort III and IV
funded subrecipient communities is a modified version of the one in use
in the SPF SIG Cohorts I and II Cross-Site Evaluation (OMB No. 0930-
0279). The total burden imposed by the original instrument was reduced
by reorganizing the format of the original instrument, optimizing the
use of skip patterns, and replacing the majority of open-ended
questions with multiple-choice-response questions.
Part I of the instrument will gather information on the
communities' progress implementing the five SPF SIG steps and efforts
taken to ensure cultural competency throughout the SPF SIG process.
Subrecipient communities receiving SPF SIG awards will be required to
complete Part I of the instrument annually. Part 2 will capture data on
the specific prevention intervention(s) implemented at the community
level. A single prevention intervention may be comprised of a single
strategy or a set of multiple strategies. A Part II instrument will be
completed for each prevention intervention strategy implemented during
the specified reporting period. Specific questions will be tailored to
match the type of prevention intervention strategy implemented (e.g.,
Prevention Education, Community-based Processes, and Environmental).
Information collected on each strategy will include date of
implementation, numbers of groups and participants served, frequency of
activities, and gender, age, race, and ethnicity of population served/
affected. Subrecipient communities' partners receiving SPF SIG awards
will be required to update Part II of the instrument a minimum of every
six months.
The estimated annual burden for specific segments of the community-
level data collection is displayed in Table 1. The burden estimates for
the CLIs are based on the experience in the Cohort I and II SPF SIG
evaluation as reported in the original OMB submission (OMB No. 0930-
0279), less the considerable reduction in length of these instruments
implemented by the Cohort III and IV evaluation team. The total burden
assumes an average of 15 community-level subrecipients per grantee
(n=36 Grantees) for a total of 540 community respondents, annual
completion of the CLI Part I, a minimum of two instrument updates per
year for the CLI Part II, and an average of three distinct prevention
intervention strategies implemented by each community during a 6-month
period. Additionally, some questions will be addressed only once and
the responses will be used to pre-fill subsequent updates.
Participant-Level Data Collection (Cohort III and IV--Continuation)
Participant-level change will be measured using the CSAP NOMs Adult
and Youth Programs Survey Forms already approved by OMB (OMB No. 0930-
0230). Subrecipient communities will have the opportunity to select
relevant measures from the CSAP NOMs Adult and Youth Programs Survey
Forms based on site-specific targeted program outcomes and may
voluntarily select additional outcome measures that are relevant to
their own initiatives. Cohort III and IV SPF SIG grantees have been
included in the currently OMB approved umbrella NOMs application (OMB
No. 0930-0230) covering all SAMHSA/CSAP grantees, therefore no
additional burden for this evaluation activity is being imposed and
clearance to conduct the activities is not being requested.
Total Estimates of Annualized Hour Burden
Estimates of total and annualized reporting burden for respondents
by evaluation cohort are displayed below in Table 1. Overall summaries
appear in Table 2. The estimated average annual burden of 5,642.9 hours
is based on the completion of the Community Level-Instrument (CLI Parts
I and II) and Sustainability Interview for Cohorts I and II, and the
Grantee-level Instruments (GLI) and the Community-Level Instrument
(CLI) for Cohorts III and IV.
Table 1--Estimates of Annualized Hour Burden to Respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
responses per Total number Burden per
Instrument Respondent Number of respondent of responses response Total burden
respondents (over four (over four (hrs.) (hrs.)
years) years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cohorts 1 and 2--Grantee Level Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
CLI grantee input....................................... Grantee 26 2 52 1 52.0
Sustainability Interview................................ Grantee 26 1 26 1.5 39.0
-------------------------------------------------------------------------------
[[Page 57032]]
Total Burden........................................ Grantee 26 3 78 2.5 91.0
-------------------------------------------------------------------------------
Average Annual Burden Over 4 Reporting years.... Grantee 26 .............. .............. .............. 22.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cohorts 1 and 2--Community Level Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
CLI Part 1............................................. Community 443 2 886 2.17 1,922.6
CLI Part 2.............................................. Community 443 8 3,544 2.17 7,690.5
Review of Past Responses................................ Community 443 2 886 2.50 2,215.0
-------------------------------------------------------------------------------
Total Burden........................................ Community 443 12 5,316 6.84 11,828.1
-------------------------------------------------------------------------------
Average Annual Burden Over 4 Reporting years.... Community 443 .............. .............. .............. 2,957.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cohorts 3 and 4--Grantee Level Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
GLI Infrastructure & Implementation Instruments Grantee 36 2 72 4.75 342.0
(Reporting Years 1-4)..................................
CLI Part I, 1-20: Community Contact Information Grantee 36 1 36 1.5 54.0
(Reporting Year 1).....................................
CLI Part I, 1-20: Community Contact Information Grantee 36 3 108 0.25 27.0
(Reporting Years 2-4)..................................
-------------------------------------------------------------------------------
Total Burden Over 4 Reporting Years................. Grantee 36 6 216 6.5 423.0
-------------------------------------------------------------------------------
Average Annual Burden........................... Grantee 9 .............. .............. .............. 105.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cohorts 3 and 4--Community Level Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
CLI Part I, 21-172: Community SPF Activities (Reporting Community 540 1 540 3 1,620.0
Year 1)................................................
CLI Part II (Reporting Year 1).......................... Community 540 6 3,240 0.75 2,430.0
CLI Part I, 21-172: Community SPF Activities (Reporting Community 540 3 1,620 0.75 1,215.0
Years 2-4).............................................
CLI Part II (Reporting Years 2-4)....................... Community 540 18 9,270 0.5 4,860.0
-------------------------------------------------------------------------------
Total Burden Over 4 Years........................... Community 540 28 15,120 5 10,125.0
-------------------------------------------------------------------------------
Average Annual Burden........................... Community 540 .............. .............. .............. 2,531.3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 2--Annualized Summary Table
----------------------------------------------------------------------------------------------------------------
Total
Respondents Number of Responses/ Total annualized
respondents respondent responses hour burden
----------------------------------------------------------------------------------------------------------------
All Cohorts--Total Burden
----------------------------------------------------------------------------------------------------------------
Cohort 1 and 2:
Grantees.................................... 26 3 78 48.8
Community................................... 443 12 5,316 2,957.0
Cohort 3 and 4:
Grantees.................................... 36 6 216 105.8
Community................................... 540 28 15,120 2,531.3
Sub-total Grantees...................... 62 .............. .............. 128.6
Sub-total Community..................... 983 .............. .............. 5,488.3
Total............................... 1045 .............. 20,730 5,616.9
----------------------------------------------------------------------------------------------------------------
[[Page 57033]]
Send comments to Summer King, SAMHSA Reports Clearance Officer,
Room 7-1044, One Choke Cherry Road, Rockville, MD 20857 and e-mail a
copy to summer.king@samhsa.hhs.gov. Written comments should be received
within 60 days of this notice.
Dated: September 10, 2010.
Elaine Parry,
Director, Office of Management, Technology and Operations.
[FR Doc. 2010-23207 Filed 9-16-10; 8:45 am]
BILLING CODE 4162-20-P
