2021-11255. Agency Emergency Information Collection Clearance Request for Public Comment

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

DATES:

Comments on the information collection request must be received on or before 10 days of this published notice.

ADDRESSES:

When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted within 10 days. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

FOR FURTHER INFORMATION CONTACT:

To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Ms. Mikia P. Currie, Office of Policy for Extramural Research Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland 20892, or call a non-toll-free number 301-435-0941 or Email your request, including your address to [e-mail]. Formal requests for additional plans and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION:

Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Title of the Collection: Audience Feedback to Inform Ongoing Messaging and Strategies for “Combat COVID”

Type of Collection: Emergency.

OMB No. 0925-NEW—Federal COVID Response

Abstract: The Federal COVID Response (FCR) Team is a cross-agency partnership that includes the U.S. Department of Health and Human Services (HHS), including the National Institutes of Health (NIH) Office of the Director, Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), the Biomedical Advanced Research and Development Authority (BARDA), and the U.S. Department of Defense (DOD). The FCR Team oversees the “Combat COVID” initiative—a multifaceted effort to provide the general public and healthcare providers with the latest evidence-based information on COVID-19 treatments and the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) clinical trials (including the combatcovid.hhs.gov website). The NIH is especially interested in recruiting participants from groups who have historically been underrepresented in clinical trials. Together with their contractor, the FCR Team is working to:

• Address participation barriers and raise awareness of ACTIV clinical trials, and
• Ensure the general public's and health care provider's needs are met as it pertains to evidence-based information on these trials.

The purpose of the information collection is to collect routine feedback from the Combat COVID Initiative's two target audiences (the general public and healthcare providers) to identify evolving needs and better disseminate relevant information relates to COVID-19 treatment and ACTIV clinical trial resources. Because the COVID-19 treatment landscape continues to evolve and audience needs continue to change, it is critical for the FCR Team to collect routine feedback from the general public (especially from groups who have not historically been well-represented in clinical trials) and healthcare providers to identify these evolving needs. By understanding evolving needs, the FCR team will be able to properly develop and broadly disseminate relevant COVID-19 treatment and ACTIV clinical trial resources. This effort will require ongoing data collection over the next 20 months (through the end of December 2022).

Data collected through this effort will be used to inform the development and broad dissemination of Combat COVID resources, including new or enhanced messages, materials and/or web pages (combatcovid.hhs.gov).

The team will employ two strategies to collect this routine audience feedback:

1. DATA COLLECTION STRATEGY 1: Monthly 60-minute virtual audience feedback teams sessions (focus groups, in-depth interviews, online bulletin boards) for rapid testing of new Combat COVID messages, concepts, ideas, resources, web pages, and materials.

2. DATA COLLECTION STRATEGY 2: 15-minute custom web surveys to understand target audiences' needs and awareness of Combat COVID over time, and to inform ongoing messages and strategies.

Estimated Annualized Burden Table

Type of respondent	Number of respondents	Number responses per respondent	Average burden per response (in hours)	Total burden hours
Consumer Audience Feedback Team Screener (Attachment 1)	120	1	5/60	10
HCP Audience Feedback Team Screener (Attachment 2)	40	1	5/60	3
Consumer Audience Feedback Activity (Attachments 3 & 5)	60	12	1	720
HCP Audience Feedback Activity (Attachments 4 & 5)	20	12	1	240
Benchmark & Follow-Up Web Surveys—Consumer Audience (Attachment 6)	2,000	5	15/60	2,500
Benchmark & Follow-Up Web Survey—HCP Audience (Attachment 6)	300	5	15/60	375
Total	2,540	12,620		3848

Dated: May 20, 2021.

Lawrence A. Tabak,

Principal Deputy Director, National Institutes of Health.