[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Pages 13923-13924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06814]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-19AEN; Docket No. CDC-2019-0027]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Stakeholder Interviews for the 
Evaluation of the World Trade Center Health Program (WTCHP) for Impact 
Assessment and Strategic Planning for Translational Research. This 
project will hold a series of semi-structured interviews with members 
of different stakeholder groups to explore their perspectives on the 
translational research mission of the WTCHP, including the use of 
research to improve care for members and impact on key program 
outcomes.

DATES: CDC must receive written comments on or before June 7, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0027 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.

    Please note:  Submit all comments through the Federal 
eRulemaking portal (regulations.gov) or by U.S. mail to the address 
listed above.


FOR FURTHER INFORMATION: To request more information on the proposed 
project or to obtain a copy of the information collection plan and 
instruments, contact Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

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 attack in New York City.
    The RTC model assumes the collective involvement of 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 
knowledge about the translation of research into improved outcomes for 
individuals and populations exposed to disasters such as

[[Page 13924]]

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 1 hour each.
    The interview will address specific topics including 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, 
and opportunities for future directions for the WTCHP.
    OMB approval is requested for one year. The total estimated burden 
is 17 hours. Participation is voluntary, and there are no costs to the 
respondent other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Principal Investigators of      Interview                      4               1               1               4
 WTCHP-Funded Research.          Discussion
                                 Guide and Brief
                                 Demographic
                                 Survey.
Leadership from WTC Clinical    Interview                      3               1               1               3
 Centers of Excellence.          Discussion
                                 Guide and Brief
                                 Demographic
                                 Survey.
WTC Health Registry staff.....  Interview                      1               1               1               1
                                 Discussion
                                 Guide and Brief
                                 Demographic
                                 Survey.
Clinicians Caring for WTCHP     Interview                      2               1               1               2
 Members.                        Discussion
                                 Guide and Brief
                                 Demographic
                                 Survey.
WTCHP Responders and Survivors  Interview                      3               1               1               3
 (State/local govt).             Discussion
                                 Guide and Brief
                                 Demographic
                                 Survey.
WTCHP Responders and Survivors  Interview                      4               1               1               4
 (private citizens).             Discussion
                                 Guide and Brief
                                 Demographic
                                 Survey.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............              17
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-06814 Filed 4-5-19; 8:45 am]
 BILLING CODE 4163-18-P