Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices 57029 

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. 

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 http://iccvam.niehs.nih.gov/ 

docs/about_docs/PL106545.pdf) 

established ICCVAM as a permanent 

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 (http:// 

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 http:// 

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: http:// 

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: http:// 

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: http:// 

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. 

Environmental Protection Agency 

Ocular Hazard Classification and 

Labeling of Antimicrobial Cleaning 

Products. NIH Publication No. 10– 

7513. Research Triangle Park, NC: 

NIEHS. Available: http:// 

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: http:// 

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. 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
57030 Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices 

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 

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 

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 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices 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 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. 

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 ..................................... Grantee 26 2 52 1 52.0 

Sustainability Interview ............................ Grantee 26 1 26 1.5 39.0 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
57032 Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices 

TABLE 1—ESTIMATES OF ANNUALIZED HOUR BURDEN TO RESPONDENTS—Continued 

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.) 

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 (Reporting Years 1–4) ......... Grantee 36 2 72 4.75 342.0 

CLI Part I, 1–20: Community Contact Information (Reporting Year 1) ............... Grantee 36 1 36 1.5 54.0 

CLI Part I, 1–20: Community Contact Information (Reporting Years 2–4) .......... 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) .................... Community 540 1 540 3 1,620.0 

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 Years 2–4) ............... Community 540 3 1,620 0.75 1,215.0 

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

Respondents Number of 

respondents 

Responses/ 

respondent 

Total 

responses 

Total 

annualized 

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 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: 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: 

Proposed Project 

Evaluation of the National Guideline 

Clearinghouse 

The mission of the Agency for 

Healthcare Research and Quality 

(AHRQ) is to enhance the quality, 

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). 

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. 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1