rev. 2021 ext SSA Generic NIHWide Fast Track

Supporting Statement A

Generic Clearance for the Collection of Qualitative

Feedback on Agency Service Delivery (NIH)

OMB Number: 0925-0648, Expiration Date: 05/31/2021

This is an extension to the original submission and all changes throughout this document are in yellow highlight.

Submitted by:

Tawanda Abdelmouti

Assistant Project Clearance Officer

OPERA/OER/OD

6705 Rockledge Drive Suite 350 Room 3505

Desk: 301-435-0978

Fax: 301-435-3059

TABLE OF CONTENTS

A. JUSTIFICATION 1

A.1 Circumstances Making the Collection of Information Necessary 1

A.2 Purpose and Use of the Information Collection 1

A.3 Use of Improved Information Technology and Burden Reduction 3

A.4 Efforts to Identify Duplication and Use Similar Information 3

A.5 Impact on Small Businesses or Other Small Entities 3

A.6 Consequences of Collecting the Information Less Frequently 3

A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 3

A.8 Comments in Response to Federal Register Notice and Efforts To

Consult Outside the Agency 3

A.9 Explanation of Any Payment or Gift to Respondents 4

A.10 Assurance of Confidentiality Provided to Respondents 4

A.11 Justification for Sensitive Questions 4

A.12 Estimates of Annualized Burden Hours and Costs 4

A.13 Estimate of Other Total Annual Cost Burden to Respondents and Record keepers 5

A.14 Annualized Cost to the Federal Government 5

A.15 Explanation for Program Changes or Adjustments 5

A.16 Plans for Tabulation and Publication and Project Time Schedule 5

A.17 Reason(s) Display of OMB Expiration Date in Inappropriate 5

A.18 Exceptions to Certification for Paperwork Reduction Act Submission 5

Attachments

1. Fast-Track Template Submission Form

1. JUSTIFICATION

Department of Health and Human Services (DHHS), National Institutes of Health (NIH), Office of the Director (OD), seeks to obtain OMB approval to extend the generic clearance to collect qualitative feedback on our service delivery for an additional three (3) years.

A.1 Circumstances Making the Collection of Information Necessary

Executive Order 12862 directs Federal agencies to provide service to the public that matches or exceeds the best service available in the private sector. To work continuously to ensure that our programs are effective and meet our customers’ needs. By qualitative feedback we mean information that provides useful insights on perceptions and opinions but are not statistical surveys that yield quantitative results that can be generalized to the population of study.

This collection of information is necessary to enable the National Institutes of Health to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the agency’s 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, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.

A.2 Purpose and Use of the Information Collection

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. The agency will collect, analyze, and interpret information gathered through this generic clearance to identify strengths and weaknesses of current services and make improvements in service delivery based on feedback. The solicitation of feedback will target areas such as: timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public (see Attachment 1). If this information is not collected, vital feedback from customers and stakeholders on the agency’s services will be unavailable.

The agency will only submit a collection for approval under this generic clearance if it meets the following conditions:

• Information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of the DHHS (if released, procedures outlined in Question 16 will be followed);

• Information gathered will not be used for the purpose of substantially informing influential policy decisions ¹;

• Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study; 

• The collections are voluntary;

• The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;

• The collections are non-controversial and do not raise issues of concern to other Federal agencies;

• Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program soon; and

• Except for information needed to provide renumeration for participants of focus groups and cognitive laboratory studies, personally identifiable information (PII) is collected only to the extent necessary and is not retained.

If these conditions are not met, the agency will submit an information collection request to OMB for approval through the normal PRA process.

To obtain approval for a collection that meets the conditions of this generic clearance, a standardized form will be submitted to OMB along with supporting documentation (e.g., a copy of the comment card). The submission will have automatic approval, unless OMB identifies issues within 5 business days.

The types of collections that this generic clearance covers include, but are not limited to:

• Customer comment cards/complaint forms

• Small discussion groups

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

• Cognitive laboratory studies, such as those used to refine questions or assess usability of a website;

• Qualitative customer satisfaction surveys (e.g., post-transaction surveys; opt-out web surveys)

• In-person observation testing (e.g., website or software usability tests)

The agency has established a manager/managing entity to serve for this generic clearance and will conduct an independent review of each information collection to ensure compliance with the terms of this clearance prior to submitting each collection to OMB.

There have been 273 projects approved under this generic clearance since its approval three years ago, all contributing significantly to the mission of NIH. These projects have ranged from focus groups to meeting and customer satisfaction surveys. The following approved sub-studies below will continue to collect data while OMB approval is pending:

• Online survey for gathering information on the audience of the Diabetes Discoveries & Practice Blog (NIDDK)

• Online survey for gathering insight on the preferences of the NIDDK Director's Update newsletter subscribers

• Live Chat User Satisfaction Survey (NIDDK)

• BRAIN Explorer Feedback Survey (NINDS)

• The NINDS Public site widget (NINDS)

• National Institute of Mental Health (NIMH) Professional Coalition for Research Progress Meeting Evaluation Form

• National Institute of Mental Health (NIMH) Core Facility User Survey

• NIMH Office of Fellowship Training (OFT) Annual Trainee Survey

• NIMH Clinical Research Education, Support, and Training (CREST) Program Customer Satisfaction Survey

• NIMH IRP Laboratory/Branch Chief Performance Satisfaction Survey

• NIMH Information Resource Center (IRC) Customer Satisfaction Surveys for Email Information Services and Online Publications Ordering Services

• 2020 NCBI ClinicalTrials.gov Website Usability Survey

• 2020 NLM Site-wide Survey for Website Satisfaction

• Annual Unified Medical Language System (UMLS) Customer Feedback Survey (NLM)

• 2020 NLM My MedlinePlus Newsletter Survey (NLM)

• 2021 Survey to Assess the Quality of Grant Review Among NIH Center for Scientific Review (CSR)

• 2021 Survey to Assess Meeting Format and Review Quality and Among NIH Grant Reviewers (CSR)

• Partnerships for Environmental Public Health Program (PEPH) Aware-Act-Use Survey (Individuals/households) (NIEHS)

• Partnerships for Environmental Public Health (PEPH) Aware-Act-Use (Private Sector) (NIEHS)

• Partnerships for Environmental Public Health (PEPH) Aware-Act-Use (State, Local or Tribal) (NIEHS)

• Partnerships for Environmental Public Health (PEPH) Aware-Act-Use (Federal Government) (NIEHS)

• Questionnaire for assessing the needs to innovate, build, modify and fix laboratory tools & equipment (NIEHS)

• NIEHS Human Health Exposure Analysis Resource (HHEAR)

A.3 Use of Information Technology and Burden Reduction

If appropriate, agency will collect information electronically and/or use online collaboration tools to reduce burden.

A.4 Efforts to Identify Duplication and Use of Similar Information

No similar data are gathered or maintained by the agency or are available from other sources known to the agency.

A.5 Impact on Small Businesses or Other Small Entities

Small business or other small entities may be involved in these efforts, but the agency will minimize the burden on them of information collections approved under this clearance by sampling, asking for readily available information, and using short, easy-to-complete information collection instruments.

A.6 Consequences of Not Conducting Collection

Without these types of feedback, the agency will not have timely information to adjust its services to meet customer needs. In addition, this would decrease the chance that federal efforts are spent on approaches that stakeholders are not responsive to or cannot benefit from.

A.7 Special Circumstances Relating to the Guidance of 5 CFR 1320.5

There are no special circumstances. The information collected will be voluntary and will not be used for statistical purposes.

A.8.1 Comments in Response to the Federal Register Notice

The 60-day Federal Register notice soliciting comments to Generic was published in Federal Register on January 21, 2021, page 36355-6356 (86 FR 6355-6356). No comments were received.

A.9 Payment or Gift

The agency will not provide payment or other forms of remuneration to respondents of its various forms of collecting feedback. Focus groups and cognitive laboratory studies are the exceptions.

In the case of in-person cognitive laboratory and usability studies, the agency may provide stipends of up to $40. In the case of in-person focus groups, the agency may provide stipends of up to $75. If respondents participate in these kinds of studies remotely, via phone, or Internet, any proposed stipend needs to be justified to OMB and must be considerably less than that provided to respondents in in-person studies, who must travel to the agency or other facility to participate. If such information collections include hard-to-reach groups and the agency plans to offer non-standard stipends, the agency will provide OMB with additional justifications in the request for clearance of these specific activities.

A.10 Confidentiality

If a confidentiality pledge is deemed useful and feasible, the agency will only include a pledge of confidentiality that is supported by authority established in statute or regulation, that is supported by disclosure and data security policies that are consistent with the pledge, and that does not unnecessarily impede sharing of data with other agency for compatible confidential use. If the agency includes a pledge of confidentiality, it will include a citation for the statute or regulation supporting the pledge.

A.11 Sensitive Nature

No questions will be asked that are of a personal or sensitive nature.

A.12.1 Burden of Information Collection

A variety of instruments and platforms will be used to collect information from respondents. The annual burden hours requested (49,333) are based on the number of collections we expect to conduct over the requested period for this clearance.

Type of Collection	No. of Respondents	Annual Frequency per Response	Hours per Response	Total Hours
Customer Satisfaction Surveys	1,000	1	30/60	500
In-Depth Interviews (IDIs) or Small Discussion Groups	1,000	1	90/60	1,500
Focus Groups	1,000	1	90/60	1,500
Usability and Pilot Testing	150,000	1	5/60	12,500
Conference/Training – Pre-and Post-Surveys	100,000	2	10/60	33,333
Total	253,000	353,000		49,333

A.12.2 Costs to Respondents

No costs are anticipated.

A.13

There are no capital or start-up costs to the data collection efforts requested; nor are there any costs associated with operation, maintenance or purchase of services.

A.14 Costs to Federal Government

The anticipated cost to the Federal Government is approximately $350,000 annually. These costs are comprised of operational expenses (e.g., equipment, overhead, printing, postage, and support staff), contractor payments and any other expense that is necessary to collect the information approved under this generic clearance.

A.15 Reason for Change

This is an extension of a currently approved submission. There are no substantive changes to this submission, or changes in burden.

A.16 Tabulation of Results, Schedule, Analysis Plans

Feedback collected under this generic clearance provides 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 are not for publication or other public release.

Although the agency does not intend to publish its findings, the agency 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 OMB’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.

A.17 Display of OMB Approval Date

We are requesting no exemption.

A.18 Exceptions to Certification for Paperwork Reduction Act Submissions

These activities comply with the requirements in 5 CFR 1320.9.

1 As defined in OMB and DHHS, "Guidelines for Ensuring the Quality of Information Disseminated to the Public," “influential” means that agency can reasonably determine that dissemination of the information will have or does have a clear and substantial impact on important public policies or important private sector decisions.”