Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Notices 28255 

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: 

‘‘Eisenberg Center Voluntary Customer 

Survey Generic Clearance for the 

Agency for Healthcare Research and 

Quality.’’ 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 July 19, 2010. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, 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@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Eisenberg Center Voluntary Customer 

Survey Generic Clearance for the 

Agency for Healthcare Research and 

Quality 

The Agency for Healthcare Research 

and Quality (AHRQ) requests that the 

Office of Management and Budget 

(OMB) renew, under the Paperwork 

Reduction Act of 1995, AHRQ’s Generic 

Clearance to collect information from 

users of work products and services 

initiated by the John M. Eisenberg 

Clinical Decisions and Communications 

Science Center (Eisenberg Center). 

AHRQ is the lead agency charged 

with supporting research designed to 

improve the quality of healthcare, 

reduce its cost, improve patient safety, 

decrease medical errors, and broaden 

access to essential services. See 42 

U.S.C. 299. AHRQ’s Eisenberg Center is 

an innovative effort aimed at improving 

communication of findings to a variety 

of audiences (‘‘customers’’), including 

consumers, clinicians, and health care 

policy makers. The Eisenberg Center 

compiles research results into a variety 

of useful formats for customer 

stakeholders. The Eisenberg Center also 

conducts its own program of research 

into effective communication of 

research findings in order to improve 

the usability and rapid incorporation of 

findings into medical practice. The 

Eisenberg Center is one of three 

components of AHRQ’s Effective Health 

Care Program, see 42 U.S.C. 299b–7. For 

the period 2005 until September 2008, 

the Eisenberg Center was operated 

through a contractual arrangement with 

the Oregon Health and Science 

University (OHSU), Department of 

Medicine, located in Portland, Oregon. 

In September 2008, the contract for 

operation of the Eisenberg Center was 

awarded to Baylor College of Medicine 

(BCM), located in Houston Texas. 

The collections proposed under this 

clearance include activities to assist in 

the development of materials to be 

disseminated through the Eisenberg 

Center and to provide feedback to 

AHRQ on the extent to which these 

products meet customer needs. These 

materials include Summary Guides that 

summarize and translate the findings of 

comparative effectiveness reviews (CER) 

and research reports for purposes of 

summarizing research findings for 

various decision-making audiences, 

such as consumers, clinicians, or 

policymakers. The guides are designed 

to help these decision makers use 

research evidence to maximize the 

benefits of health care, minimize harm, 

and optimize the use of health care 

resources. In addition, each year of the 

project the Eisenberg Center will 

develop one computerized, interactive 

decision aid for those clinical problems 

identified from selected CERs. The 

intent is for the decision aid to increase 

the patient/consumer’s knowledge of 

the health condition, options, and risk/ 

benefits, lead to greater assurance in 

making a decision, increase the 

congruence between values and choices, 

and ethance involvement in the 

decision making process. Information 

collections conducted under this 

generic clearance are not required by 

regulation and will not be used to 

regulate or sanction customers. Surveys 

will be entirely voluntary, and 

information provided by respondents 

will be combined and summarized so 

that no individually identifiable 

information will be released. The 

Eisenberg Center will produce from 17 

to a maximum of 33 Summary Guides 

per audience (i.e., clinician, 

policymaker, consumer) per year, 

depending on the information needed 

for each product with each audience. 

In accordance with OMB guidelines 

for generic clearances for voluntary 

customer surveys and Executive Order 

12862, AHRQ has established an 

independent review process to assure 

the development, implementation, and 

analysis of high quality customer 

surveys within AHRQ. Specifically, 

AHRQ understands that each activity 

conducted must be submitted to OMB 

with a supporting statement and 

accompanying instruments. Information 

collection may not proceed until 

approved by OMB. 

Method of Collection 

Information collections conducted 

under this clearance will be collected 

via the following methods: 

• Focus Groups. Focus groups may 

include clinical professionals, patients 

or other health care consumers, or 

health policy makers. They will be used 

to provide input regarding the needs for 

products and for the development of 

Decision Aids and Summary Guides. 

Focus groups may also be used to test 

draft products to determine if intended 

information and messages are being 

delivered through products that are 

produced and disseminated through the 

Eisenberg Center. 

• In-person or Telephone Interviews. 

Interviews will be conducted with 

individuals from one or more of the 

three groups identified above. The 

purpose of these interviews is to (1) to 

provide input regarding the 

development of Decision Aids and 

Summary Guides, (2) to determine if 

intended information and messages are 

being delivered effectively through 

products that are produced and 

disseminated through the Eisenberg 

Center, and (3) to engage the subject in 

cognitive testing to (a) determine if 

changes in topical knowledge levels can 

be identified following exposure to 

Eisenberg Center informational or 

instructional products, and (b) identify 

strengths and weaknesses in products 

and services for purposes of making 

improvements that are practical and 

feasible. 

• Customer Satisfaction Survey for 

the Decision Aids. Baseline survey data 

will be collected on both clinician and 

patient characteristics, characteristics of 

the health care condition, and selected 

outcome measures such as knowledge 

and decisional self-efficacy. Following 

delivery of the decision aid, a user 

survey will be completed to explore 

subjects’ impressions of the tool, 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
28256 Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Notices 

including ease of use, clarity of 

presentation, length, balance of 

information, rating of interactive 

features, and overall satisfaction. Both 

clinicians and patients/consumers will 

be surveyed. For patients, the customer 

satisfaction survey will include 

decisional outcome measures (e.g., 

decisional conflict, desire for 

involvement in decision-making), 

measures of attitudes and self-efficacy, 

and indicators of choice intention or 

actual choice made. If the aid is 

evaluated within a clinical context, 

measures of physician-patient 

interaction will also be considered. 

Additionally, clinicians may be 

interviewed about the impact of the aid 

on clinical flow. 

• Customer Satisfaction Surveys for 

the Summary Guides. These surveys 

will be offered to health care 

professionals, consumers, and policy 

makers that use the online Summary 

Guides. Respondents will report via 

Likert-type or numerical response scales 

how specific informational or 

educational products or materials 

influenced health care or clinical 

practice behaviors. 

• Follow-up CME Surveys. Continuing 

Medical Education (CME) credit will be 

offered to physicians who wish to 

participate in online activities 

developed around the Summary Guides 

for clinicians. Three months after 

completing the educational activity, 

physicians will be asked to complete a 

follow-up survey to assess realized 

changes in clinical practice, barriers to 

making change, and self-assessed 

impacts on patient care. 

• Solicited Topic Nominations. 

Visitors to the Web site will have the 

opportunity to provide information 

about suggested topics that might be 

addressed through the research and 

dissemination efforts of the EHC 

program. 

• Web site Registration. Visitors to the 

Web site will be able to register personal 

contact information (e.g., name, e-mail 

address) if wishing to receive updated 

information and materials as they 

become available. 

• Glossary Feedback Survey. Visitors 

to the Web site who access the health 

care glossary will be asked to suggest 

missing terms and provide additional 

comments on definitions or usage 

sentences, if desired. 

This information will be used to 

develop, improve and/or maintain high 

quality products and services to lay and 

health professional publics. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden for the respondents 

time to participate in this research. 

These estimates assume a maximum of 

33 Summary Guides per year and 

separate Guides for clinicians, policy 

makers and consumers and are thus 

slight overestimates. 

Focus groups will be used for needs 

assessment and will be conducted with 

clinicians and consumers for 

development of the Summary Guides, 

and additionally with policymakers for 

those Guides in which policy 

recommendations are applicable. Focus 

groups will be conducted with no more 

than 1,056 persons per year and will last 

about 11⁄2 hours. 

Once the Summary Guides are 

developed they will be subjected to inperson or telephone interviews for 

purposes of usability and product 

testing with clinicians, policy makers 

and consumers. In-person telephone 

interviews will be conducted twice with 

about 1,386 persons annually and will 

take about 66 minutes on average. Two 

rounds of interviews will be conducted 

with all consumer representatives 

during product development, with a 

second round of interviews conducted 

occasionally with clinicians and policy 

makers, as needed. 

Customer satisfaction surveys for the 

Summary Guides will be conducted 

with approximately 6,600 

representatives from the audience to be 

targeted by the Summary Guides 

annually (i.e., clinician, policymaker or 

consumer) and will take 5 minutes to 

complete. 

Customer satisfaction surveys will 

also be administered to approximately 

50 clinicians and 500 patients in 

evaluating the Decision Aid. These 

surveys will take about 10 minutes to 

complete, and will be administered 

before and after implementation of the 

Decision Aid in the study populations. 

Clinicians that have completed CME 

accrediting requirements and are 

requesting CME credit will be asked to 

complete the follow-up CME Survey 

three months following completion of 

the online activity. This data collection 

will be completed with about 1,320 

clinicians annually and will require 5 

minutes to complete. 

Approximately 2,500 solicited topic 

nomination forms will be completed 

annually by healthcare professional and 

consumer visitors to the Web site and 

will require about 5 minutes to 

complete. Web site Registration will be 

completed by all persons wanting to 

stay up-to-date with the latest 

information from the Eisenberg Center, 

about 6,000 annually, and requires 

about 5 minutes to complete. The 

Glossary Feedback Survey will be 

completed by about 200 persons 

annually that access the glossary and 

takes 5 minutes to complete. The total 

burden hours are estimated to be 6,203. 

Exhibit 2 shows the estimated 

annualized cost burden associated with 

the respondents time to participate in 

this research. The cost burden is 

estimated to be $290,227 annually. 

Exhibit 1. Estimated Annualized 

Burden Hours 

Type of data collection Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Focus Groups .......................................................................................... 1,056 1 1.5 1,584 

In-person/Telephone Interviews .............................................................. 1,386 2 1.1 3,050 

Customer Satisfaction Surveys for the Decision Aid ............................... 550 2 10/60 184 

Customer Satisfaction Surveys for the Summary Guides ....................... 6,600 1 5/60 550 

Follow-up CME Surveys .......................................................................... 1,320 1 5/60 110 

Solicited Topic Nominations .................................................................... 2,500 1 5/60 208 

Web site Registration .............................................................................. 6,000 1 5/60 500 

Glossary Feedback Survey ..................................................................... 200 1 5/60 17 

Total .................................................................................................. 19,612 (1) (1) 6,203 

1 Not applicable. 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Notices 28257 

Exhibit 2. Estimated Annualized Cost 

Burden 

Type of data collection Number of 

respondents 

Total burden 

hours 

Average hourly 

wage rate * 

Total cost 

burden 

Focus Groups .......................................................................................... 1,056 1,584 $48.98 $77,584 

In-person/Telephone Interviews .............................................................. 1,386 3,050 46.82 142,801 

Customer Satisfaction Surveys for the Decision Aid ............................... 550 184 25.53 4,698 

Customer Satisfaction Surveys for the Summary Guides ....................... 6,600 550 39.55 21,753 

Follow-up CME Surveys .......................................................................... 1,320 110 77.64 8,540 

Solicited Topic Nominations .................................................................... 2,500 208 48.07 9,999 

Web site Registration .............................................................................. 6,000 500 48.07 24,035 

Glossary Feedback Survey ..................................................................... 200 17 48.07 817 

Total .................................................................................................. 19,612 6,203 (1) 290,227 

1 Not applicable. 

* Based upon the mean and weighted mean wages for clinicians (29–1062 family and general practitioners), policy makers (11–0000 management occupations, 11–3041 compensation & benefits managers, 13–1072 compensation, benefits & job analysis specialists, 11–9111 medical 

and health service managers, 13–2053 insurance underwriters and 15–2011 actuaries) and consumers (00–0000 all occupations). Focus groups 

include 528 clinicians ($77.64/hr) and 528 consumers ($20.32/hr); in-person/telephone interviews includes 528 clinicians, 330 policy makers 

($39.91/hr) and 528 consumers; customer satisfaction surveys for the decision aid includes 50 clinicians and 500 consumers; customer satisfaction surveys for the summary guides includes 1,650 clinicians, 1,650 policy makers and 3,300 consumers; follow-up CME surveys includes 1,320 

clinicians; solicited topic nominations include 1,125 clinicians, 250 policy makers and 1,125 consumers; Web site registration includes 2,700 clinicians, 600 policy makers and 2,700 consumers; glossary feedback survey includes 90 clinicians, 20 policy makers and 90 consumers, National 

Compensation Survey: Occupational wages in the United States May 2008, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ 

Estimated Annual Costs to the Federal 

Government 

The maximum cost to the Federal 

Government is estimated to be 

$1,439,003 annually. Exhibit 3 shows 

the total and annualized cost by the 

major cost components. 

Exhibit 3. Estimated Total and 

Annualized Cost 

Cost component Total 

cost 

Annualized 

cost 

Project Development ....................................................................................................................................................... $1,019,970 $339,990 

Data Collection Activities ................................................................................................................................................. 735,405 245,135 

Data Processing and Analysis ......................................................................................................................................... 1,889,505 629,835 

Project Management ........................................................................................................................................................ 557,380 185,793 

Overhead ......................................................................................................................................................................... 114,750 38,250 

Total .......................................................................................................................................................................... 4,317,010 1,439,003 

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: May 10, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–11993 Filed 5–19–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0226] 

Draft Guidance for Industry, Third 

Parties and Food and Drug 

Administration Staff; Medical Device 

ISO 13485:2003 Voluntary Audit Report 

Submission Program; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Medical Device ISO 

13485:2003 Voluntary Audit Report 

Submission Program.’’ This draft 

guidance is intended to provide 

information on the implementation of a 

section of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA), which amends a section 

of the Federal Food, Drug, and Cosmetic 

Act (the act). This guidance document 

describes how FDA’s Center for Devices 

and Radiological Health (CDRH) and 

Center for Biologics Evaluation and 

Research (CBER) are implementing this 

provision of the law. This draft 

guidance is not final nor is it in effect 

at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1