2390 Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices 

Background Information on ICCVAM 

and NICEATM 

ICCVAM is an interagency committee 

composed of representatives from 15 

Federal regulatory and research agencies 

that require, use, generate, or 

disseminate toxicological and safety 

testing information. 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 hazards of chemicals and products 

and that reduce, refine (decrease or 

eliminate pain and distress), or replace 

animal use. The ICCVAM Authorization 

Act of 2000 established ICCVAM as a 

permanent interagency committee of the 

NIEHS under NICEATM (42 U.S.C. 

285l–3(a)). NICEATM administers 

ICCVAM, provides scientific and 

operational support for ICCVAM-related 

activities, and conducts independent 

validation studies to assess the 

usefulness and limitation of new, 

revised, and alternative 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 and technical evaluations. 

Additional information about ICCVAM 

and NICEATM can be found on the 

NICEATM–ICCVAM Web site (http:// 

iccvam.niehs.nih.gov). 

References 

EPA. 2003. Health Effects Test 

Guidelines: OPPTS 870.2600—Skin 

Sensitization. EPA 712–C–03–197. 

Washington, DC: U.S. 

Environmental Protection Agency. 

Available: http://www.epa.gov/ 

ocspp/pubs/frs/publications/ 

Test_Guidelines/series870.htm. 

ICCVAM 2010 ICCVAM Test Method 

Evaluation Report. The Murine 

Local Lymph Node Assay: BrdUELISA, a Nonradioactive 

Alternative Test Method to Assess 

the Allergic Contact Dermatitis 

Potential of Chemicals and 

Products. NIH Publication No. 10– 

7552. Research Triangle Park, NC: 

National Institute of Environmental 

Health Sciences. Available at: 

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

methods/immunotox/llna-ELISA/ 

TMER.htm. 

ICCVAM. 2010. ICCVAM Test Method 

Evaluation Report. The Murine 

Local Lymph Node Assay: DA, a 

Nonradioactive Alternative Test 

Method to Assess the Allergic 

Contact Dermatitis Potential of 

Chemicals and Products. NIH 

Publication No. 10–7551. Research 

Triangle Park, NC: National 

Institute of Environmental Health 

Sciences. Available at: http:// 

iccvam.niehs.nih.gov/methods/ 

immunotox/llna-D/TMER.htm. 

ICCVAM. 2010. ICCVAM Test Method 

Evaluation Report on Using the 

LLNA for Testing Pesticide 

Formulations, Metals, Substances in 

Aqueous Solutions, and Other 

Products. NIH Publication No. 10– 

7512. Research Triangle Park, NC: 

National Institute of Environmental 

Health Sciences. Available at: 

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

methods/immunotox/LLNA-app/ 

TMER.htm. 

ICCVAM. 2009. Recommended 

Performance Standards: Murine 

Local Lymph Node Assay. NIH 

Publication No. 09–7357. Research 

Triangle Park, NC: National 

Institute of Environmental Health 

Sciences. Available at: http:// 

iccvam.niehs.nih.gov/methods/ 

immunotox/llna_PerfStds.htm. 

ICCVAM. 1999. The Murine Local 

Lymph Node Assay: A Test Method 

for Assessing the Allergic Contact 

Dermatitis Potential of Chemicals/ 

Compounds. The Results of an 

Independent Peer Review 

Evaluation Coordinated by ICCVAM 

and NICEATM. NIH Publication No. 

99–4494. Research Triangle Park, 

NC: National Institute of 

Environmental Health Sciences. 

Available at: http:// 

iccvam.niehs.nih.gov/methods/ 

immunotox/llna_PeerPanel98.htm. 

ISO. 2002. Biological evaluation of 

medical devices—10993 Part 10: 

Tests for irritation and delayed-type 

hypersensitivity. Available for 

purchase at: http://www.iso.org/iso/ 

home.htm. 

ISO. 2010. Biological evaluation of 

medical devices—10993 Part 10: 

Tests for irritation and skin 

sensitization. Available for 

purchase at: http://www.iso.org/iso/ 

home.htm. 

OECD. 2002. Test Guideline 429. Skin 

Sensitization: Local Lymph Node 

Assay, adopted April 24, 2002. In: 

OECD Guidelines for Testing of 

Chemicals. Paris: OECD. 

OECD. 2010a. Test Guideline 429. Skin 

Sensitization: Local Lymph Node 

Assay, adopted July 22, 2010. In: 

OECD Guidelines for Testing of 

Chemicals. Paris: OECD. Available 

at: http://dx.doi.org/10.1787/ 

9789264071100-en. 

OECD. 2010b. Test Guideline 442B. 

Skin Sensitization: Local Lymph 

Node Assay: BrdU-ELISA, adopted 

July 22, 2010. In: OECD Guidelines 

for Testing of Chemicals. Paris: 

OECD. Available at: http:// 

dx.doi.org/10.1787/9789264090996- 

en. 

OECD. 2010c. Test Guideline 442A. 

Skin Sensitization: Local Lymph 

Node Assay: DA, adopted July 22, 

2010. In: OECD Guidelines for 

Testing of Chemicals. Paris: OECD. 

Available at: http://dx.doi.org/ 

10.1787/9789264090972-en. 

Dated: January 5, 2011. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2011–669 Filed 1–12–11; 8:45 am] 

BILLING CODE 4140–01–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: 

‘‘Connecting Primary Care Practices with 

Hard-to-Reach Adolescent Populations.’’ 

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 March 14, 2011. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by 

e-mail 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@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 


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Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices 2391 

Proposed Project 

Connecting Primary Care Practices With 

Hard-to-Reach Adolescent Populations 

The overall goal of this exploratory 

project is to improve the quality of 

adolescent health care. The project will 

address suboptimal adolescent care with 

respect to health risk behaviors, which 

can have serious health consequences. 

In particular, failure to address health 

risk behaviors among adolescents (e.g., 

smoking, substance abuse, poor diets, 

physical inactivity, and high-risk sexual 

behavior) contributes significantly to 

increased morbidity and mortality. 

Adolescents (11–17 years of age) 

constitute 17% of the population of the 

U.S., but they are responsible for only 

7% of medical office visits. As a result, 

primary care providers have relatively 

less opportunity to evaluate and counsel 

adolescents in their offices than most 

other patients. Even when adolescents 

receive routine health care, open 

communication with their health care 

providers may be problematic. A 

national survey found that the majority 

of adolescent boys and girls in the U.S. 

report at least 1 of 8 potential health 

risks, but most (63%) had not spoken to 

their doctor about any of these (Klein & 

Wilson, 2002). Improved engagement 

and communication between 

adolescents and their primary care 

providers could increase the likelihood 

that effective preventive services and 

health care are provided. It could also 

improve the efficiency of health care 

services for adolescents, in terms of 

appointments kept and adherence to 

recommended screening or treatment 

recommendations. 

Technological interventions to 

improve care may be particularly 

appropriate for adolescents, since they 

are typically the early adopters of new 

technology (Skinner, Biscope, Poland, & 

Goldberg, 2003). Use of in-office 

electronic screeners before 

appointments has proven useful (Olson, 

Gaffney, Lee, & Star 2008; Salerno, 2008; 

Yi, Martyn, Salerno, & Darling-Fisher, 

2009). Outside of the office, youth have 

increasingly turned to the internet for 

health-related information, and have 

also rapidly adopted mobile technology 

(Lenhart, Ling, Campbell, & Purcell. 

2010) and social media (Lenhart, 

Purcell, Smith, & Zickuhr, 2010). Health 

plans (e.g., Kaiser Permanente) and 

practices (Hawn, 2009) have conducted 

early work in applying patient-centered 

web and mobile technologies. These 

projects have included interventions to 

decrease patient no-show rates, increase 

the use of sunscreen, and engage 

adolescents in diabetes management. 

Much work remains to be done, 

however, in understanding how primary 

care practices can best embrace 

advances in communications and 

information technology to improve 

health outcomes for adolescent patients. 

This project has the following goals: 

(1) Explore the benefits of 

supplementing an electronic in-office 

pre-visit screener with a set of web 

technologies for adolescent outreach 

and engagement outside of office visits. 

a. The Rapid Assessment for 

Adolescent Preventive Services © 

(RAAPS), as described below, will be 

used for in-office pre-visit screening 

b. The web technologies will include 

(i) a web page for more static content 

such as information about practices and 

health-related commentary from 

practice clinicians and staff, (ii) a 

Facebook page for social interaction 

about health topics including topical 

content that will engage adolescents in 

conversations about general, not 

personal, health behaviors and 

encouraging youth to discuss these 

issues with their primary care 

practitioners at clinic visits, and (iii) a 

Twitter site that will allow youth to use 

mobile phones with text messaging to 

subscribe to Facebook posts. 

(2) Increase adolescent visits to 

primary care and identification of health 

risks during visits 

(3) Promote healthier behavior in four 

domains: (1) Diet, (2) physical activity, 

(3) substance abuse (smoking, alcohol, 

and use of other recreational drugs), and 

(4) sexual health 

(4) Develop a manual of best practices 

for these components in primary care. 

This study is being conducted by 

AHRQ through its contractor, State 

Network of Colorado Ambulatory 

Practices and Partners (SNOCAP–USA), 

a practice-based research network 

(PBRN) based at the University of 

Colorado Denver, pursuant to AHRQ’s 

statutory authority to conduct and 

support research on healthcare and on 

systems for the delivery of such care, 

including activities with respect to the 

quality, effectiveness, efficiency, 

appropriateness and value of healthcare 

services and with respect to clinical 

practice, including primary care and 

practice-oriented research. 42 U.S.C. 

299a(a)(l) and (4). 

Method of Collection 

This project will be conducted in four 

primary care practice sites that have a 

substantial number of adolescent 

patients. The following activities and 

data collections will be implemented: 

(1) RAAPS questionnaire. Practices 

will use the 21-item RAAPS 

questionnaire for in-office pre-visit 

screening. RAAPS was developed by the 

University of Michigan Regional 

Alliance for Healthy Schools to elicit 

information about risky adolescent 

behaviors that should be addressed, but 

often are missed, in primary care. It is 

available in both paper and online 

forms; the latter will be used in this 

project. The primary purpose of the 

RAAPS questionnaire is to improve 

clinical recognition of risky behaviors so 

that personal counseling may be 

provided. 

(2) Process measures for web 

technologies. For each of the web 

technologies used (the web page, 

Facebook page, and Twitter site), data 

on the number of unique visitors, the 

frequency of their visits, and their 

activities (e.g. whether they create a new 

post or ‘‘like’’ postings) will be obtained 

by the research team. These data will 

not include personally identifiable 

information (e.g. the user’s username, 

birth date, IP address, etc.). OMB 

clearance is not required for this data 

collection. 

(3) Extraction of medical record data. 

Staff members at each practice will use 

their clinical information systems to 

extract medical record data for use by 

the research team. Data to be extracted 

consist of (a) Contact information for 

patients seen in the 18 months prior to 

the start date for implementation of 

RAAPS and the web technologies. This 

is the sample frame for the adolescent 

behavior and communication survey. 

These data will be used by the project 

staff to prepare the recruitment 

mailings. (b) Clinic notes for adolescents 

seen in the 12 months prior to 

implementation start date and for 

adolescents seen in the 12 months 

following the implementation start date. 

Clinic notes will be made accessible 

either by pulling paper charts or 

printing notes from electronic medical 

records. The notes will be reviewed and 

abstracted by the research team to assess 

whether the intervention had the 

intended effect of increasing adolescent 

visits to primary care and the 

identification of potential health risks 

during visits. 

(4) Consent-assent form. This is used 

to obtain consent from the parent or 

guardian and assent from the adolescent 

to participate in the adolescent behavior 

and communication survey. 

(5) Adolescent behavior and 

communication survey. A questionnaire 

(by mail, with an online option) will be 

administered twice to adolescent 

patients for whom consent-assent has 

been obtained: Once at baseline and 

again six months after the intervention. 

The purpose of this survey is to measure 

the adolescent’s level of comfort with 

discussing their health with their 


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2392 Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices 

clinician and their level of satisfaction 

with their medical care, and to see how 

this changes after the intervention. 

(6) Post-visit satisfaction survey. 

Practices will provide adolescents with 

a brief, post-card sized anonymous 

questionnaire at every office visit during 

the study period. The purpose is to 

assess the perceived utility of the 

RAAPS questionnaire, and whether the 

visit was related to the project’s web 

technologies. 

(7) Adolescent focus groups. Eight 

adolescents (two from each practice) 

will provide feedback on the web page, 

Facebook, and Twitter pages. There will 

be one in-person group meeting 

preimplementation, followed by a series 

of 3 additional asynchronous group 

discussions conducted via the web at 

three-month intervals. These provide a 

process for user-centered design and 

refinement of the of web technologies. 

(8) Adolescent ‘‘think-aloud’’ sessions. 

These sessions, which will be 

conducted near the end of the study 

period, will involve a set of eight 

adolescent patients (two from each 

practice) that did not participate in the 

focus groups. Subjects will come to the 

practice for individual sessions in 

which they will be asked to say aloud 

what they are thinking about the Web 

technologies as they navigate them as 

they typically would. The purpose is to 

assess the perceived utility of the 

components of the Web, Facebook, and 

Twitter pages. 

(9) Clinician semi-structured 

interviews. At each site, individual 

interviews will be conducted with two 

clinicians (eight clinicians total). The 

purpose is to assess clinician 

perceptions of the effects of the RAAPS 

questionnaire and the Web technologies 

on the clinical encounter and the care 

they provide. 

(10) Administrator-staff semistructured interviews. At each site, 

semi-structured interviews will be 

conducted with the practice manager 

and a front-desk staff member. The 

purpose is to assess the effect of the 

interventions on the check in process 

and other business processes. 

(11) Semi-structured interviews for 

the draft manual. The draft manual of 

best practices in primary care for 

adoption of Web and assessment 

technologies (such as the RAAPS 

questionnaire) developed by the 

research team will be sent to the 

practice manager and the practice 

director (lead clinician) of each site. 

Their feedback will be solicited by 

telephone roughly two weeks later. This 

‘‘member checking’’ enhances the 

validity of the manual’s conclusions and 

recommendations. 

The results from this exploratory 

project will be used to inform 

development of a manual to assist 

primary care practices in adopting 

interventions to improve the 

effectiveness of their outreach to and 

interactions with adolescent patients. In 

addition, information collected in the 

RAAPS questionnaire may be used by 

clinicians to improve clinical care. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondents’ time to participate in this 

research. Among the 776 adolescent 

patients across the 4 participating 

practices, 310 are expected to complete 

the RAAPS questionnaire, which takes 

about 15 minutes to complete, at each 

office visit (on average there will be an 

estimated 1.25 office visits per patient). 

Practice staff members will perform the 

extraction of medical record data preimplementation, and again postimplementation, for 50 patients. This 

task is estimated to require 4 hours per 

practice (slightly less than 5 minutes per 

patient record). 

The consent-assent form for 

participation in the adolescent behavior 

and communication survey will be sent 

to the homes of all adolescents in the 

practice’s panels. The estimated average 

time for reading and responding to the 

form is 15 minutes. The adolescent 

behavior and communication survey 

will be completed twice, pre- and postintervention, by 233 adolescent patients 

and requires 15 minutes to complete. 

The post-visit satisfaction survey will be 

completed by each of the 310 

participating adolescent patients after 

each office visit and will take 5 minutes 

to complete. 

A series of four focus groups will be 

held with 8 adolescent patients over the 

course of the study period with each 

session lasting about 1.5 hours. In 

addition to the focus groups one ‘‘thinkaloud’’ session will be held with a group 

of 8 adolescent patients and will also 

take 1.5 hours. 

Feedback from the practice staff and 

the clinicians will be obtained through 

3 different semi-structured interviews. 

Two staff members from each of the 4 

practices will participate in these 

interviews. The clinician and 

administrator-staff semi-structured 

interviews will each last 30 minutes. 

Semi-structured interviews for the draft 

manual will require about one hour total 

(30 minutes to review the manual and 

30 minutes to participate in the 

interview). The total annualized burden 

is estimated to be 548 hours. 

Exhibit 2 shows the estimated 

annualized cost burden associated with 

the respondents’ time to participate in 

this research. The total annual cost 

burden is estimated to be $8,601. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Activity/data collection Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

RAAPS questionnaire ...................................................................................... 310 1 .25 15/60 97 

Extraction of medical record data .................................................................... 4 2 4 32 

Consent-assent form ....................................................................................... 776 1 15/60 194 

Adolescent behavior and communication survey ............................................ 233 2 15/60 117 

Post-visit satisfaction survey ............................................................................ 310 1 .25 5/60 32 

Adolescent focus groups ................................................................................. 8 4 1 .5 48 

Adolescent ‘‘think-aloud’’ sessions .................................................................. 8 1 1 .5 12 

Clinician semi-structured interviews ................................................................ 4 2 30/60 4 

Administrator-staff semi-structured interviews ................................................. 4 2 30/60 4 

Semi-structured interviews for the draft manual .............................................. 4 2 1 8 

Total .......................................................................................................... 1,661 na na 548 


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Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices 2393 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Activity/data collection Number of respondents 

Total burden 

hours 

Average hourly wage rate 1

Total cost 

burden 

RAAPS questionnaire ...................................................................................... 310 97 $9.01 2 $874 

Extraction of medical record data .................................................................... 4 32 18.15 3 581 

Consent-assent form ....................................................................................... 776 194 22.11 4 4,289 

Adolescent behavior and communication survey ............................................ 233 117 9.01 2 1,054 

Post-visit satisfaction survey ............................................................................ 310 32 9.01 2 288 

Adolescent focus groups ................................................................................. 8 48 9.01 2 432 

Adolescent ‘‘think-aloud’’ sessions .................................................................. 8 12 9.01 2 108 

Clinician semi-structured interviews ................................................................ 4 4 84.53 5 338 

Administrator-staff semi-structured interviews ................................................. 4 4 29.63 6 119 

Semi-structured interviews for the draft manual .............................................. 4 8 64.75 7 518 

Total .......................................................................................................... 1,661 548 na 8,601 

1 Mean hourly and wage costs for Colorado were derived from the Bureau of Labor and Statistics National Compensation Survey for May 2009 

(http://www.bls.gov/oes/current/oes_co.htrn). 2 Hourly rate for an entry level worker (occupation code 3 5–0000) estimates the cost of time for adolescents, although many will not be employed. 3 Hourly rate for medical records and health information technician (29–2071). 

4 Hourly rate for the mean for all occupations (00–0000) estimates the cost of time for the parent or guardian of the adolescent.

5Average of hourly rates for a family medicine practitioner (29–1062) and a general internist (29–1063). 

6Average of (1) the hourly rate for a medical and health services manager (11–9111) and (2) the average of the hourly rates for a receptionist 

(43–4171) and a medical assistant (31–9092). 7Average of (1) the hourly rate for a medical and health services manager (11–9110) and (2) the average of the hourly rates for a family medicine practitioner (29–1062) and a general internist (29–1063). 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the estimated total 

and annualized cost to the Federal 

Government for conducting this 

research. These estimates include the 

costs associated with the project such as 

the preparation of survey administration 

procedures, labor costs, administrative 

expenses, costs associated with copying, 

postage, and telephone expenses, data 

management and analysis, and 

preparation of final reports. The 

annualized and total costs are identical 

since the data collection period will last 

for one year. The total cost is estimated 

to be $436,524. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost component Total cost Annualized cost 

Project Development ................................................................................................................................... $72,364 $72,364 

Data Collection Activities ............................................................................................................................. 48,904 48,904 

Data Processing and Analysis ..................................................................................................................... 73,937 73,937 

Publication of Results .................................................................................................................................. 21,890 21,890 

Project Management .................................................................................................................................... 75,733 75,733 

Overhead ..................................................................................................................................................... 143,696 143,696 

Total ...................................................................................................................................................... 436,524 436,524 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ healthcare research and 

healthcare information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’ s estimate of 

burden (including hours and costs) of 

the proposed collection(s) 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 upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: January 4, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–408 Filed 1–12–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–11–0338] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 


srobinson on DSKHWCL6B1PROD with NOTICES