[Federal Register Volume 83, Number 236 (Monday, December 10, 2018)]
[Notices]
[Pages 63515-63516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26633]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-19-18PR]


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 The World Trade Center Health Program 
(WTCHP): Impact Assessment and Strategic Planning for Translational 
Research (Part 1, Formative Research: Focus Groups) 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 March 15, 2018 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 
(404) 639-7570 or send an email to [email protected]. 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 (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    The World Trade Center Health Program: Impact Assessment and 
Strategic Planning for Translational Research (Part 1, Formative 
Research: Focus Groups)--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

[[Page 63516]]

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 conduct an 
independent evaluation of the WTCHP RTC model including the research 
investments to date and the effectiveness with which the Program 
translates its research to different stakeholder groups. RAND was 
selected given the project team's expertise with similar assessments 
and NIOSH's requirement for an objective analysis. This work will 
ultimately provide guidance for the WTCHP on strategic directions, as 
well as produce new knowledge about the translation of research into 
improved outcomes for individuals and populations exposed to disasters 
such as, but not limited to, the 9/11 attacks. In the formative stage 
of our assessment, we propose to hold a series of focus groups with 
different stakeholder groups to explore their perspectives on 
translational research in the context of the WTCHP. The focus groups 
will each consist of a well-defined stakeholder group, and will last 
approximately two hours. Focus group discussions will be held in-person 
or by telephone or webinar format. Depending on the timing of OMB 
approval, RAND anticipates conducting focus groups shortly after, most 
likely in the winter/early spring of 2019. If this occurs, results will 
be analyzed in the spring of 2019. If the timing of OMB approval 
coincides with one of the twice-yearly NIOSH-sponsored research 
meetings in NYC, RAND plans to hold in-person focus groups with the 
stakeholder groups in attendance (NIOSH and principal investigators, 
typically); the remainder of the focus groups will be held by webinar 
to minimize burden on the participants.
    These focus groups are necessary to gather background information 
on the relationship between different stakeholders and the WTCHP that 
will complement data gathered during more detailed interviews with 
stakeholders in the interviews that will take place 6-12 months later. 
Specific topics to be addressed in the focus groups will include: 
Conceptualizations of research and ``translational research;'' 
relevance of WTCHP research topics, potential gaps, and stakeholder 
priorities, including responsiveness to regulatory issues; uses and 
usefulness of WTCHP research; barriers to conduct and use of WTCHP 
research; and understanding of and perspectives on the relevance and 
usefulness of the Research-to-Care model.
    OMB approval is requested for one year. The total estimated burden 
in hours is 220. Participation is voluntary and there are no costs to 
the respondent other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Principal Investigators of WTCHP-       Focus Group Discussion                30               1               2
 Funded Research.                        Guide and Brief
                                         Demographic Survey.
Leadership from WTC Clinical Centers    Focus Group Discussion                20               1               2
 of Excellence and Other Stakeholders.   Guide and Brief
                                         Demographic Survey.
WTC Health Registry staff.............  Focus Group Discussion                10               1               2
                                         Guide and Brief
                                         Demographic Survey.
Clinicians Caring for WTCHP Members...  Focus Group Discussion                20               1               2
                                         Guide and Brief
                                         Demographic Survey.
WTCHP Responders and Survivors (State/  Focus Group Discussion                15               1               2
 local govt).                            Guide and Brief
                                         Demographic Survey.
WTCHP Responders and Survivors          Focus Group Discussion                15               1               2
 (private citizens).                     Guide and Brief
                                         Demographic Survey.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2018-26633 Filed 12-7-18; 8:45 am]
 BILLING CODE 4163-18-P