Supporting Statement Part A 09152020

SUPPORTING STATEMENT

Part A

Questionnaire and Data Collection Testing, Evaluation, and Research for the Agency for Healthcare Research and Quality

OMB Number 0935-0124

Version: April 24, 2020

Agency of Healthcare Research and Quality (AHRQ)

Table of contents

A. Justification 3

1. Circumstances that make the collection of information necessary 3

2. Purpose and use of information 4

3. Use of Improved Information Technology 4

4. Efforts to Identify Duplication 5

5. Involvement of Small Entities 5

6. Consequences if Information Collected Less Frequently 5

7. Special Circumstances 5

8. Consultation outside the Agency 5

9. Payments/Gifts to Respondents 5

10. Assurance of Confidentiality 6

11. Questions of a Sensitive Nature 6

12. Estimates of Annualized Burden Hours and Costs 6

13. Estimates of Annualized Respondent Capital and Maintenance Costs 7

14. Estimates of Annualized Cost to the Government 7

15. Changes in Hour Burden 7

16. Time Schedule, Publication and Analysis Plans 7

17. Exemption for Display of Expiration Date 8

List of Attachments 8

A. Justification

1. Circumstances that make the collection of information necessary

The mission of the Agency for Healthcare Research and Quality (AHRQ) set out in its authorizing legislation, The Healthcare Research and Quality Act of 1999 (see Attachment A), 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 systems practices, including the prevention of diseases and other health conditions. AHRQ shall promote health care quality improvement by conducting and supporting:

1. research that develops and presents scientific evidence regarding all aspects of health care; and

2. the synthesis and dissemination of available scientific evidence for use by patients, consumers, practitioners, providers, purchasers, policy makers, and educators; and

3. initiatives to advance private and public efforts to improve health care quality.

Also, AHRQ shall conduct and support research and evaluations, and support demonstration projects, with respect to (A) the delivery of health care in inner-city areas, and in rural areas (including frontier areas); and (B) health care for priority populations, which shall include (1) low-income groups, (2) minority groups, (3) women, (4) children, (5) the elderly, and (6) individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care.

The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) re-approve generic pre-testing clearance 0935-0124 for three years to facilitate AHRQ’s efforts to (1) employ evaluation-type methods and techniques to improve AHRQ’s current data collection and estimation procedures, (2) develop new collections and procedures, including toolkits, and (3) revise existing collections and procedures. AHRQ uses techniques to simplify data collection and estimation procedures, reduce respondent burden, and improve efficiencies to meet the needs of individuals and small business respondents who may have reduced budgets and staff. AHRQ believes that developing, testing, and evaluating data collection and estimation procedures using survey methods and other techniques in anticipation of agency-sponsored studies can improve its information collection efforts and the products it develops and allow AHRQ to be more responsive to fast-changing developments in the healthcare research field.

This clearance request is limited to research on data collection, toolkit development, and estimation procedures and reports and does not extend to the collection of data for public release or policy formation.

This generic clearance will allow AHRQ to draft and test toolkits, survey instruments and other data collection and estimation procedures more quickly and with greater lead time, thereby managing project time more efficiently and improving the quality of the data AHRQ collects. In some instances, the ability to test and evaluate toolkits, data collection and estimation procedures in anticipation of work or early in a project may result in the decision not to proceed with additional activities, thereby saving both public and private resources and effectively eliminating respondent burden.

Many of the tools AHRQ develops are made available to the private sector to assist in improving health care quality. The health and health care environment changes rapidly and requires a quick response from AHRQ to provide refined tools. This generic clearance will facilitate AHRQ’s response to this changing environment.

These preliminary research activities will not be used by AHRQ to regulate or sanction its customers. They will be entirely voluntary and the confidentiality of respondents and their responses will be preserved. Proposed information collections submitted under this generic clearance will be reviewed and acted upon by OMB within 14 days of submission to OMB.

2. Purpose and Use of Information

The information collected through preliminary research activities will be used by AHRQ to employ techniques to (1) improve AHRQ’s current data collection and estimation procedures, (2) develop new collections and procedures, including toolkits, and (3) revise existing collections and procedures in anticipation or in response to changes in the health or health care field. The end result will be improvement in AHRQ’s data collections and procedures and the quality of data collected, a reduction or minimization of respondent burden, increased agency efficiency, and improved responsiveness to the public.

3. Use of Improved Information Technology

One of the goals of this effort is to identify and evaluate advanced techniques that will help AHRQ obtain the necessary amount of information with a minimum amount of burden through the use of electronic submission to substitute for paper and automated processes whenever feasible.

4. Efforts to Identify Duplication

Work carried out under this clearance will be designed to reflect specific program and customer population needs of the program for which the work is being conducted and it is not anticipated to duplicate any other evaluation or testing of data collection and estimation procedures being done by AHRQ or other Federal agencies.

5. Involvement of Small Entities

The survey instruments and procedures for completing the instruments will be designed to minimize burden on all respondents and will not have a significant impact on small businesses or other small entities.

6. Consequences if Information Collected Less Frequently

Only testing and evaluation of data collection and estimation procedures ensures the efficiency in terms of respondent burden and quality of the resulting information to inform policy.

7. Special Circumstances

Data collections conducted under this generic clearance will be consistent with the general information collection guidelines of 5 CFR 1320.5(d)(2). No special circumstances apply.

8. Federal Register Notice and Outside Consultations

8.a. Federal Register Notice

As required by 5 CFR 1320.8(d), notice was published in the Federal Register June 10^th, 2020 on Page 35425 for 60 days (see Attachment B). No substantive comments were received.

8.b. Outside Consultations

AHRQ will consult with statistical and other expert staff in-house, in other Federal agencies, and in other organizations that have conducted, or may engage in similar preliminary research activities. According to OMB guidelines for generic clearances and as indicated in ‘Item 1’ above, AHRQ will establish an independent internal review process to assure the development, implementation, and analysis of high quality research.

9. Payments/Gifts to Respondents

AHRQ will, on a case-by-case basis, consider modest remuneration for survey respondents and focus group participant’s time and travel. In such cases, the remuneration will typically not exceed $30 per individual. AHRQ may ask for a higher amount for hard to reach populations. Remuneration for focus group participation is a recognized standard industry practice, without which, it would be difficult to achieve appropriate and adequate participation.

10. Assurance of Confidentiality

Individuals and organizations will be assured of the confidentiality of their replies under Section 934(c) of the Public Health Service Act, 42 USC 299c-3(c). They will be told the purposes for which the information is collected and that, in accordance with this statute, any identifiable information about them will not be used or disclosed for any other purpose.

11. Questions of a Sensitive Nature

It is possible that in developing data collection and estimation procedures, potentially sensitive questions may be included. One of the purposes of these efforts is to identify such questions, determine sources of sensitivity, and alleviate them insofar as possible before an actual data collection or estimation procedure is conducted. If questions of a sensitive nature are proposed, this will be noted and a justification will be included in the materials submitted to OMB for their review and approval.

12. Estimates of Burden Hours and Costs Over 3 Years

Exhibit 1 shows the estimated burden hours, over the full 3 years of this clearance, for the respondents’ time to participate in the research activities that may be conducted under this generic clearance. Mail surveys will be conducted with about 6,000 persons (2,000 per year for 3 years) and are estimated to average 20 minutes. Mail surveys may also be sent to respondents via email, and may include a telephone non-response follow-up. Telephone non-response follow-up for mailed surveys is not counted as a telephone survey in Exhibit 1. Not more than 600 persons, over 3 years, will participate in telephone surveys that will take about 40 minutes. Web-based surveys will be conducted with no more than 3,000 persons and will require no more than 10 minutes to complete. About 1,500 persons will participate in focus groups which may last up to two hours, while in-person interviews will be conducted with 600 persons and will take about 50 minutes. Automated data collection will be conducted for about 1,500 persons and could take up to 1 hour. Cognitive testing will be conducted with about 600 persons and is estimated to take 1½ hours to complete. The total burden over 3 years is estimated to be 8,900 hours (about 2,967 hours per year).

Exhibit 2 shows the estimated cost burden over 3 years, based on the respondent’s time to participate in these research activities. The total cost burden is estimated to be $357,869.

Exhibit 1.  Estimated burden hours over 3 years

Type of Information Collection	Number of Respondents	Number of Responses per Respondent	Hours per Response	Total Burden Hours
Mail/email*	6,000	1	20/60	2,000
Telephone	600	1	40/60	400
Web-based	3,000	1	10/60	500
Focus Groups	1,500	1	2.0	3,000
In-person	600	1	1.0	600
Automated**	1,500	1	1.0	1,500
Cognitive Testing***	600	1	1.5	900
Totals	13,800	na	na	8,900

^* May include telephone non-response follow-up in which case the burden will not change

^** May include testing of database software, CAPI software or other automated technologies.

^*** May include cognitive interviews for questionnaire or toolkit development, or “think aloud” testing of prototype websites.

Exhibit 2. Estimated cost burden over 3 years

Type of Information Collection	Number of Respondents	Total Burden Hours	Average Hourly Wage Rate*	Total Cost Burden
Mail/email	6,000	2,000	$40.21	$ 80,420
Telephone	600	400	$40.21	$16,084
Web-based	3,000	500	$40.21	$20,105
Focus Groups	1,500	3,000	$40.21	$120,630
In-person	600	600	$40.21	$24,126
Automated	1,500	1,500	$40.21	$60,315
Cognitive Testing	600	900	$40.21	36,189
Totals	13,800	8,900	na	$357,869

* Bureau of Labor & Statistics on “Occupational Employment and Wages, May 2019” found at the following URL: https://www.bls.gov/oes/current/oes_nat.htm#b29-0000.htm for the respondents.

13. Estimates of Annualized Respondent Capital and Maintenance Costs

Capital and maintenance costs include the purchase of equipment, computers or computer software or services, or storage facilities for records, as a result of complying with this data collection. There are no direct costs to respondents other than their time to participate in the study.

14. Estimates of Annualized Cost to the Government

Information collections conducted under this generic clearance will in some cases be carried out under contract. Assuming four data collections per year (either mail/email, telephone, web-based or in-person) at an average cost of $150,000 each, and four focus groups, automated data collections or lab experiments at an average cost of $20,000 each, total contract costs could be $680,000 per year. An additional annual cost of about $25,392 for agency staff would be associated with this assuming four surveys and four focus groups, automated data collections or lab experiments per fiscal year with four GS14/5 program analysts or project officers ($126,958 annual salary*) and 5% of their time each fiscal year. The total annual cost to the government is estimated to be $705,392.

.

*Based on 2017 OPM Pay Schedule for Washington/DC area: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2017/DCB.pdf

15. Changes in Hour Burden

There is no change in the total number of burden hours.

16. Time Schedule, Publication and Analysis Plans

The information will be used for data collection and estimation procedure development and to employ new techniques to improve AHRQ’s current data collections and procedures, to develop new collections and procedures, and to revise existing collections and procedures. AHRQ will disseminate findings only when appropriate and may include presentations at professional meetings; publications in AHRQ internal media vehicles, or policy guidelines; or publications in professional journals or books whose focus is evaluation methods and/or testing. Definitive plans for analysis or timetable of key activities will be provided for each information collection under this generic clearance at the time that it is submitted to OMB. Information collection will not begin until OMB has been notified of a proposed activity and approved of the activity.

17. Exemption for Display of Expiration Date

AHRQ does not seek this exemption.

List of Attachments:

Attachment A -- Healthcare Research and Quality Act of 1999

Attachment B – Examples of surveys conducted under this generic clearance
Attachment C – 30 day Federal Register no