FINAL Supporting Statement A Extension 8-17-20

Supporting Statement A

Questionnaire and Data Collection Testing and Developmental Research for the Health Resources and Services Administration (HRSA)

OMB Control No. 0915-0379

Extension

Terms of Clearance: “None”.

A. Justification

1. Circumstances Making the Collection of Information Necessary

HRSA requests that the Office of Management and Budget (OMB) extend approval of the generic pre-testing clearance for three years to facilitate HRSA’s efforts to (1) conduct developmental research designed to improve HRSA’s current data collection and estimation procedures, (2) conduct formative research surrounding potential new collections and procedures, and (3) explore options for revising existing collections and procedures. HRSA 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. Developing, testing, and evaluating data collection and estimation procedures using survey methods and other techniques in anticipation of agency-sponsored studies can improve HRSA’s information collection efforts and the products developed by HRSA. This allows HRSA to be more responsive to fast-changing developments in the healthcare research field.

Through this generic clearance, HRSA is able to develop and test survey instruments and other data collection and estimation procedures expeditiously and with greater lead-time, thereby managing project time more efficiently and improving the quality of the data HRSA collects. In some instances, the ability to test and evaluate data collection and estimation procedures as a precursor to potential projects 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.

These information collection activities may also be applied to exploring potential sources of respondent nonresponse so that improved protocols can be designed to minimize these sources of nonresponse. Sources of nonresponse errors include item-level definitional problems, unrealistic reference periods that make unreasonable cognitive demands on the respondent, confusing sequencing of items, etc.

The cumulative effects of these sources of respondent nonresponse are decreased levels of item- and survey-level participation. These respondent errors can result in inaccurate reporting and challenges to successfully tracking nonresponse for survey follow-up data collection efforts.

The positive outcomes derived from conducting these cognitive efforts and implementing evidence-based improvements include (1) enhancing the ability to minimize item- and instrument-level respondent error, (2) increasing the likelihood of study participation and (3) decreasing the need for follow-up data collection with study nonrespondents.

These developmental activities are not used by HRSA to regulate or sanction its grantees or other constituencies. Participation in these activities is entirely voluntary, and the privacy of respondents will be preserved to the extent permitted by law. We understand that when practicable and feasible, OMB will begin processing individual Gen IC’s submitted under this information collection clearance within two weeks of submittal.

In accordance with OMB guidelines for generic clearances for voluntary surveys, HRSA has an independent review process (see Supporting Statement B, #5) to ensure the development and implementation of high quality surveys within HRSA. Survey instruments developed for use under this generic clearance will be submitted to OMB for review and inclusion in the public docket.

2. Purpose and Use of Information Collection

HRSA conducts cognitive interviews, focus groups, field tests/pilot interviews, and experimental research in laboratory and field settings, both for evaluating questionnaires and more basic research on response errors in surveys.

The information collected through preliminary research activities is used by HRSA to employ techniques to (1) improve HRSA’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 leads to improvement in HRSA’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. In the absence of these preliminary research activities, HRSA would pursue research activities without pre-testing, which could lead to increased burden time for respondents and less efficient data collection procedures.

The scope of the generic information collections will be uncontroversial and of limited public interest. Survey questions that directly address public health emergency related issues will be outside of the scope of this generic clearance while general survey questions such as those that address workforce satisfaction will be within scope.

As HRSA’s Information Collection Clearance Officer staff cannot anticipate all future survey needs, HRSA staff will work with the OMB Desk Officer on the individual generic “child” submissions to ensure that all generic information collections are uncontroversial and of limited public interest.

During a public health emergency such as COVID-19, safety precautions will be taken as necessary during all project phases. For example, interviews and other survey activities will be conducted virtually or via telephone to ensure participants’ safety.

3. Use of Improved Information Technology and Burden Reduction

Usually, cognitive interviews will be conducted in the mode or modes intended for the survey, that is, face-to-face; telephone, self-administered, computer assisted personal interviewing (CAPI), computer assisted telephone interviewing (CATI), audio computer-assisted self-interview (ACASI), self-administered web-based, or some combination of modes.

One of the goals of this effort is to identify and evaluate advanced techniques that will help HRSA 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. Only the minimum amount of information necessary will be collected from respondents.

4. Efforts to Identify Duplication and Use of Similar Information

Work carried out under this clearance will be designed to address the 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 HRSA or other Federal agencies.

5. Impact on Small Businesses or Other 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 of Collecting the Information Less Frequently

Individual projects usually involve one-time data collection activities. There are no legal obstacles to reducing the burden.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

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

8. Comments in Response to the Federal Register Notice/Outside Consultation

Section 8A:

As required be 5 CFR 1320.8(d), a 60-day Federal Register Notice was published in the Federal Register on March 2, 2020, vol. 85, No. 41; pp. 12307-12308. No comments were received.

Section 8B:

HRSA 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. Proposals for information collection under this generic clearance will be developed by program offices and submitted for review and approval by the Office of Planning, Analysis, and Evaluation (OPAE) in HRSA. OPAE directs the OMB information collection clearance program for HRSA, as well as other data policy and planning activities within HRSA. The HRSA information collection clearance officer is a social science analyst with expertise in survey methodology and questionnaire design, and familiarity with principles of sampling and data analysis.

9. Explanation of any Payment/Gift to Respondents

For most testing projects, cognitive interview respondents receive remuneration for several reasons:

• Typically, respondents are recruited for specific characteristics that are related to the subject matter of the survey (e.g., questions may be relevant only to people with certain health conditions). The more specific the subject matter, the more difficult it is to recruit eligible respondents. Remuneration helps to attract a greater number of potential respondents.

• Cognitive interviews require an unusual level of mental effort, as respondents are asked to explain their mental processes as they hear the question, discuss its meaning and any ambiguities, and describe why they answered the questions the way they did.

The “default” for much of this work will be not to offer incentives. However, when deemed necessary, for instance, when individuals are recruited to travel to a cognitive interviewing site, respondents may be eligible for an incentive of $20-40. This amount is designed to remunerate for travel associated costs as well as child-care and related expenses in addition to encouraging travel. If higher remunerations are be requested due to documented difficulties in identifying eligible participants, they will be evaluated on a case-by-case basis for particularly difficult recruitments. For example, focus group remuneration might occasionally rise higher than the $20- $40 range but never above $100. It is sometimes important to offer remuneration sufficient to attract the full range of needed respondent types, and specifically across different modes. Inadequate respondent recruitment limits the effectiveness of the questionnaire evaluation. Requests and justification for remuneration will be included in each individual collection submission.

10. Assurance of Confidentiality Provided to Respondents

Data will be kept private to the extent allowed by law. 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. Justification for Sensitive Questions

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 Annualized Hour and Cost Burden

Table 12A 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. The total burden over 3 years is estimated to be 3,200 hours.

12A. Estimated Three-year Burden (Hours)

Type of Information Collection	Number of Respondents	Number of Responses per Respondent	Total Responses	Average Burden per Response (in hours)	Total Burden Hours
Mail/email1	1,000	1	1,000	0.26	260
Telephone	1,000	1	1,000	0.26	260
Web-based	1,000	1	1,000	0.25	250
Focus Groups	725	1	725	1.0	725
In-person	500	1	500	1.0	500
Automated2	500	1	500	1.0	500
Cognitive Testing	500	1	500	1.41	705
Total	5,225	--	5,225	--	3,200

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

² May include testing of database software, CAPI software, or other automated technologies.

12B. Costs to respondents

No costs are anticipated. Remuneration to respondents is designed to compensate them for their effort and any out-of-pocket costs. Table 12B 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 $107,232.

Estimated Annualized Burden Costs

Type of Information Collection	Number of Respondents	Total Burden Hours	Average Hourly Wage ($25.72) Rate * Doubled to Account for Fringe Benefits and Overhead Costs	Total Cost Burden
Mail/email	1,000	260	$51.44	$13,374.40
Telephone	1,000	260	$51.44	$13,374..40
Web-based	1,000	250	$51.44	$12,860.00,377.50
Focus Groups	725	725	$51.44	$37,294.00
In-person	500	500	$51.44	$25,720.00
Automated	500	500	$51.44	$25,720
Cognitive Testing	500	705	$51.44	$36,265.20
Totals	5,225	3,200		$164,608

* Based upon the mean hourly wage for 00-0000 (All Occupations), “May 2019 National Occupational Employment and Wage Estimates United States,” U.S. Department of Labor, Bureau of Labor Statistics.

13. Estimates of other Total Annual Cost Burden to Respondents or Recordkeepers/Capital Costs

There are no direct costs to respondents other than their time to participate in the study.

14. Annualized Cost to Federal Government

Information collections conducted under this generic clearance will in some cases be carried out under contract. Assuming eight data collections per year (either mail/email, telephone, web-based or in-person) at an average cost of $150,000 each, and ten focus groups, automated data collections or lab experiments at an average cost of $20,000 each, total contract costs could be $1,400,000 per year.

The cost to the government consists mainly of the salaries of the HRSA staff that will (1) assist the questionnaire designers in the design of appropriate laboratory instruments, (2) recruit, schedule, and assist in interviewing volunteer respondents, and (3) assist in the analysis of the results and recommend changes in questionnaire wording:

Managerial 1 FTE $124,000

Professional 7 FTE $644,000

Support 1 FTE $89,000

Annual Total (contracts and staff) $2,257,000

15. Explanation for Program Changes or Adjustments

There is no change in the estimated burden.

16. Plans for Tabulation, Publication, and Project Time Schedule

The information will be used for data collection and estimation procedure development: to employ new techniques to improve HRSA’s current data collections and procedures, to develop new collections and procedures, and to revise existing collections and procedures. Definitive plans for analysis or timetable of key activities will be provided for each information collection under this generic clearance at the time that the specific information collection is submitted to OMB. Information collection will not begin until OMB has been notified of a proposed activity and approved of the activity.

17. Reason(s) Display of OMB Expiration Date is Inappropriate

Not applicable.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

Not applicable. There are no exceptions to the certification.

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