Supporting Statement

Supporting Statement for Paperwork Reduction Act Generic Information Collection Submission for

HRSA Division of Transplantation (DoT) Qualitative Assessment of Outreach Materials

1. JUSTIFICATION

1. Circumstances of Information Collection

The Health Resources and Services Administration (HRSA) currently has approval under the generic clearance, Office of Management and Budget (OMB) Control No. 0915-0212, to conduct customer satisfaction surveys and focus groups. This collection of information helps fulfill the requirements of:

Executive Order 12862 directs Federal agencies to provide service to the public that matches or exceeds the best service available in the private sector. In order to work continuously to ensure that our programs are effective and meet our customers’ needs, HRSA’s Healthcare System Bureau’s Division of Transplantation (DoT) seeks to obtain OMB approval of a generic clearance to collect qualitative feedback on our service delivery. By qualitative feedback, we mean information that provides useful insights on perceptions and opinions, not statistical surveys that yield quantitative results that can be generalized to the population of study.

DoT will obtain feedback from customers, potential customers, delivery partners, and other stakeholders of its outreach materials on organ donation and transplantation. These materials are a vital part of DoT’s mission to extend and enhance the lives of individuals with end-stage organ failure (Organ Donation and Recovery Improvement Act, 42 USC 201SEC 377A (a)).

This collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery and increasing the number of donors. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with DoT’s materials and programs. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between DoT and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of DoT program management.

2. Purpose and Use of the Information

Improving agency programs requires ongoing assessment of service delivery, by which we mean systematic review of the operation of a program compared to a set of explicit or implicit standards, as a means of contributing to the continuous improvement of the program. As a vital part of its ongoing mission, DoT produces outreach and information materials on organ donation and transplantation for numerous audiences, including both consumer and professional audiences. These materials are designed to respond to and anticipate customer needs and requirements, including providing information about organ donation and information on how to register to become an organ donor.

DoT is seeking to collect information to assess these materials’ strengths and weaknesses, and to make improvements to the materials and their delivery based on customer feedback. Feedback will include areas such as the appropriateness of the materials, their accuracy, and the efficiency of their delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on DoT’s services will be unavailable.

The collection of this information will be qualitative, voluntary and non-controversial. Collection will be targeted to the opinions of consumers who support organ donation and would consider registering as donors but have not yet done so, as well as the professionals who supply these consumers with information on organ donation (e.g., clergy or healthcare professionals).

DoT is requesting generic clearance to conduct:

• Individual interviews with customers, potential customers, delivery partners, or other stakeholders

• Focus groups of customers, potential customers, delivery partners, or other stakeholders

These qualitative approaches will provide DoT with the information it needs to improve its materials and service delivery. DoT intends to conduct interviews and focus groups with each of eight critical customer groups (see question 12). Each customer group has unique needs, and DoT has existing materials for each of these groups. Thus, DoT is requesting to conduct qualitative interviews with each group.

3. Use of Improved Information Technology

The interviews and focus groups will not employ information technology but will be conducted by telephone and/or in-person, which is the most appropriate and cost-effective methodology to obtain feedback from these respondents. We have also limited the design to the smallest number of respondents possible to further reduce the overall burden.

4. Efforts to Identify Duplication

The Department of Health and Human Services is the only Cabinet Department with statutory responsibility for organ donation. Within the HHS, responsibility for implementing efforts to increase organ donation is delegated to DoT. To the best of our knowledge, no other entity within the Federal Government has gathered or is planning to gather similar data. The attached qualitative instruments have been reviewed carefully to avoid potential duplication.

5. Involvement of Small Entities

Healthcare professionals will be involved in this project, some of whom may qualify as small businesses (e.g., a doctor with her/her own practice). We will minimize the participation of these individuals (drawing mostly from nurses, physician assistants, and others with non-small business employers) for representation in this group. Additionally, all participation in this project is completely voluntary, and related activities will be scheduled outside of normal business hours to further reduce impact.

6. Consequences if Information Collected Less Frequently

Without this type of feedback, DoT will not have timely information to modify its outreach materials to meet customer needs.

7. Consistency with the Guidelines in 5 CFR 1320.5 (d)(2)

These surveys will be implemented in a manner fully consistent with 5 CFR 1320.5(d)(2).

8. Consultation Outside the Agency

In accordance with 5 CFR 1320.8(d), on April 24, 2009, a 30 day notice was published in the Federal Register for HRSA’s generic clearance, OMB Control No. 0915-0212 (Vol. 74, Page 18726). No public comments were received. The surveys for this activity were developed by DoT staff.

9. Remuneration of Respondents

This request involves individual interviews and focus groups. DoT will provide a stipend of $40 for participants of in-person individual interviews, lasting one hour, $35 for interviews conducted over the telephone, lasting one hour, and a stipend of $75 for participants in focus groups, lasting two hours. These stipends are necessary to ensure the validity of the findings, as potential respondents are likely to be unwilling to participate in these activities without receiving compensation for their time.

10. Assurance of Confidentiality

This assessment does not involve the collection of personally identifiable information except in order to provide compensation for participants. All collection will fully comply with all aspects of the Privacy Act, and participants will be notified that their responses will be kept confidential.

Participation is fully voluntary and responses are confidential. Tape recordings of the groups and interviews will only be conducted with respondent permission. These recordings will be used solely to verify notes taken for accuracy and then destroyed. Respondents will be assured that neither their participation/non-participation nor any of their responses to items will have any effect on their participation in Agency programs.

11. Questions of a Sensitive Nature

As a part of the screening process for selecting participants, DoT will collect information on race and ethnicity. This information is necessary since many of DoT’s existing materials are designed specifically for specific racial or ethnic groups. Many of these audiences are disproportionately represented on transplant waiting lists and have had well documented health disparities.

12. Estimates of Annualized Hour Burden

Individual interviews and focus groups will be used to collect information from respondents. The annual burden hours requested (383) are based on the number of collections we expect to conduct over the requested period for this clearance.

Estimated Annual Reporting Burden
Type of Collection	No. of Respondents	Annual Frequency per Response	Hours per Response	Total Hours
Individual interviews	63	1	1	63
Focus groups	160	1	2	320

DoT is requesting to conduct interviews with each of eight identified groups of customers, potential customers, delivery partners, or other stakeholders. DoT will conduct two focus groups (10 participants per group) with each audience, and nine interviews with every group except professionals. Identified customer/stakeholder groups include:

1. General public (any adult aged 18 and over)

2. African Americans

3. Hispanics/Latinos (English-speaking)

4. Hispanics/Latinos (Spanish-speaking)

5. Asians, Native Hawaiians, and other Pacific Islanders (ANHOPI)

6. Young adults

7. Adults age 50 and over

8. Professional audiences, including healthcare professionals (doctors, nurses, physician’s assistants, and others who regularly work with patients), clergy, and teachers

To ensure the diversity of each individual group, no participant who would qualify as a professional audience will be able to participate in groups 1-7. Additionally, a maximum of two young adults and two adults aged 50 and over will be allowed in groups 1-5. Finally, at least half of group 1 will consist of adults who are not eligible for any other category.

13. Estimates of Annualized Cost Burden to Respondents

No appreciable costs are anticipated. Any out-of pocket expenses (phone minutes, mileage to focus group facility, etc.) would be more than offset by the honorarium.

13. Estimates of Annualized Cost to the Government

The anticipated cost to the Federal Government is approximately $150,000. These costs are comprised of: contractor payments, recruitment of participants, participant stipends, facility rental, participant refreshments, transcription, translation, recordings and electronic remote feeds for offsite viewing.

13. Change in Burden

Not applicable. This is a new request for a generic ICR.

13. Plans for Analysis and Timetable of key Activities

Feedback collected will provide useful information, but it does not yield data that can be generalized to the overall population. Findings will be used for general service improvement, but not for publication or other public release. DoT will use findings to improve and enhance its outreach products and services, including altering delivery mechanisms to better meet identified customer needs, enhancing and improving content, and consolidating content.

Although DoT does not intend to publish its findings, DoT may receive requests to release the information (e.g., congressional inquiry, Freedom of Information Act requests). The Agency will disseminate the findings when appropriate, strictly following the Agency's "Guidelines for Ensuring the Quality of Information Disseminated to the Public," and will include specific discussion of the limitation of the qualitative results discussed above.

13. Exemption for Display of Expiration Date

No exemption is being requested. The expiration date will be displayed.

13. Certifications

These activities comply with the requirements in 5 CFR 1320.9.

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