[Federal Register Volume 83, Number 51 (Thursday, March 15, 2018)]
[Notices]
[Pages 11535-11536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05242]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-18PR; Docket No. CDC-2018-0021]


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 The World Trade Center Health 
Program (WTCHP): Impact Assessment and Strategic Planning for 
Translational Research--Focus Group Protocol. This project includes a 
series of focus groups with different stakeholder groups to explore 
their perspectives on the decisions that each of them makes in the 
context of the WTCHP.

DATES: CDC must receive written comments on or before May 14, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0021 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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 CONTACT: 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

    The World Trade Center Health Program: Impact Assessment and 
Strategic Planning for Translational Research (Focus Group Protocol)--
New--National Institute for Occupational Safety and Health (NIOSH), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The James Zadroga 9/11 Health and Compensation Act of 2010, Public 
Law 111-347 (hereafter referred to as ``the Zadroga Act''), established 
the World Trade Center Health Program (WTCHP). Under subtitle C, the 
Zadroga Act requires the establishment of a research program on health 
conditions resulting

[[Page 11536]]

from the 9/11 terrorist attacks. Thus, the CDC seeks a one-year OMB 
approval to collect information using focus groups.
    The WTCHP employs the Research-to-Care (RTC) model strategic 
framework employed 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 Research and Development (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. 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.
    These focus groups are necessary to gather background information 
on the relationship between different stakeholders and the WTCHP that 
will inform the development of more detailed interview protocols to be 
used with stakeholders in the next phase of this evaluation. 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.
     Uses and usefulness of WTCHP research.
     Barriers to conduct and use of WTCHP research.
     Understanding of and perspectives on the relevance and 
usefulness of the Research-to-Care model.
    The total estimated burden hours is 360. There are no costs to the 
respondent other than their time and local travel to the location of 
the focus group.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                         Average
                                                        Number of       Number of      burden per       Total
      Type of respondents             Form name        respondents    responses per   response (in   burden  (in
                                                                       respondent        hours)         hours)
----------------------------------------------------------------------------------------------------------------
WTCH Researchers...............  Focus Group                     40               1               3          120
                                  Protocol.
WTCH Research Users............  Focus Group                     70               1               3          210
                                  Protocol.
WTCH Funders (NIOSH)...........  Focus Group                     10               1               3           30
                                  Protocol.
                                                    ------------------------------------------------------------
    Total......................  ..................  ..............  ..............  ..............          360
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-05242 Filed 3-14-18; 8:45 am]
 BILLING CODE 4163-18-P