2019-17297. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Stakeholder Interviews for the Evaluation of the World Trade Center Health Program for Impact Assessment and Strategic Planning for Translational Research, to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on April 8, 2019 to obtain comments from the public and affected agencies. The WTCHP is administered by the CDC/National Institute for Occupational Safety and Health (NIOSH). CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call [phone] or send an email to [e-mail]. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to [phone]. Provide written comments within 30 days of notice publication.

Proposed Project

Stakeholder Interviews for the Evaluation of the World Trade Center Health Program for Impact Assessment and Strategic Planning for Translational Research—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The World Trade Center Health Program (WTCHP) was established by the James Zadroga 9/11 Health and Compensation Act of 2010, Public Law 111-347 (hereafter referred to as “the Zadroga Act”). Under subtitle C, the Zadroga Act requires the establishment of a research program on health conditions resulting from the 9/11 terrorist attacks. The Research to Care (RTC) model is the strategic framework employed by the WTCHP to prioritize, conduct, and assess research that informs excellence in clinical care for the population of responders and survivors affected by the 9/11 attacks in New York City. It is the focus of this assessment.

The RTC model assumes the collective involvement of different WTCHP stakeholders, including members, researchers, clinicians, and program administrators. It accounts for a variety of inputs that can affect the progress and impact of WTCHP research. These inputs include people and organizations (e.g., program members, providers, clinical centers of excellence, extramural researchers, and program staff), resources (e.g., technology, data centers, the NYC 9/11 Health Registry) and regulatory rules, principally the Zadroga Act. The program supports activities such as research prioritization, conduct of research, delivery of medical care, and iterative assessments of the translation of research to improvements in health care services and chronic disease management. These activities aim to produce tangible outputs such as research findings on WTC-related conditions, healthcare protocols, peer-reviewed publications, quality assessment reports, and member and provider education products. Finally, the model anticipates short-, intermediate-, and long-term measurement of outcomes and serves as a communication tool for program planning and evaluation.

In 2016, NIOSH contracted with the RAND Corporation to evaluate the WTCHP RTC model including the research investments to date and the effectiveness with which the Program translates its research to different stakeholder groups. This work will ultimately provide guidance for the WTCHP on strategic directions, as well as produce generalizable knowledge about the translation of research into improved outcomes for individuals and populations exposed to disasters such as the 9/11 attacks. As a part of this evaluation, we will hold a series of interviews with representatives of different stakeholder groups to explore their perspectives on translational research in the context of the WTCHP. These interviews are necessary to gather information on the translation of WTCHP-supported research into better care for members, the impact of this research, and stakeholders' views on future directions for the program. Interview responses will be incorporated into RAND's overall assessment of the WTCHP program's research portfolio and will inform recommendations for future research investments and strategic direction. We will conduct 20 semi-structured, in-depth interviews by telephone that will last approximately one hour each. Three of the 20 participants are NIOSH employees and are excluded from the burden estimate. The burden estimate is based on the 17 respondents who are not NIOSH employees.

Specific topics to be addressed in the interviews will include:

• Stakeholder views on key findings from a large systematic review of WTC-related research conducted in a separate part of this evaluation.
• Adherence of WTCHP-supported research to key principles of translational research: Relevance, transparency, and usefulness of the research.
• Examples of use of the research.
• Impact of the research on program outcomes as defined by the Research-to-Care logic model.
• Opportunities for future directions for the WTCHP, which is funded through 2090.

OMB approval is requested for one year. Participation is voluntary, and there are no costs to respondents other than their time. The total estimated annualized burden is 17 hours.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Principal Investigators of WTCHP-Funded Research	Interview Discussion Guide and Brief Demographic Survey	4	1	1
Leadership from WTC Clinical Centers of Excellence	Interview Discussion Guide and Brief Demographic Survey	3	1	1
WTC Health Registry staff	Interview Discussion Guide and Brief Demographic Survey	1	1	1
Clinicians Caring for WTCHP Members	Interview Discussion Guide and Brief Demographic Survey	2	1	1
WTCHP Responders and Survivors (State/local govt)	Interview Discussion Guide and Brief Demographic Survey	3	1	1
WTCHP Responders and Survivors (private citizens)	Interview Discussion Guide and Brief Demographic Survey	4	1	1

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.