[Federal Register Volume 88, Number 80 (Wednesday, April 26, 2023)]
[Notices]
[Pages 25406-25407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08756]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2023-0027, NIOSH-350]


World Trade Center Health Program; Youth Research Cohort; Request 
for Information

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

ACTION: Request for information.

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SUMMARY: The Centers for Disease Control and Prevention's (CDC) 
National Institute for Occupational Safety and Health (NIOSH), in the 
Department of Health and Human Services, announces an opportunity for 
the public to provide information about approaches to establishing a 
new World Trade Center (WTC) Health Program research cohort of persons 
who were exposed to the September 11, 2001, terrorist attacks and were 
aged 21 years or younger at the time of their exposure. This research 
cohort will be designed to allow the WTC Health Program to conduct 
future research studies on the health and educational impacts in the 
population of persons aged 21 years or younger at the time of their 
exposures to airborne toxins, or any other hazard or adverse condition, 
resulting from the terrorist attacks on September 11, 2001. Once 
established, this new WTC Health Program ``youth cohort'' would serve 
as the basis for future WTC Health Program research into the health and 
educational impacts of this potentially vulnerable group, hereafter 
referred to as ``WTC Youth.'' Information is requested on specific 
adverse health, social, and educational effects that are of interest 
for future research; desired characteristics of the proposed cohort and 
associated control groups (e.g., size and demographics), and methods 
for identifying, recruiting, and obtaining informed consent from 
members; as well as data collection, storage, and management methods 
necessary for future research investigations.

DATES: Comments must be received by August 24, 2023.

ADDRESSES: Comments may be submitted through either of the following 
two methods:
     Federal eRulemaking Portal: http://www.regulations.gov 
(follow the instructions for submitting comments), or
     By Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS C-34, 1090 Tusculum Avenue, Cincinnati, Ohio 45226-1998.
    Instructions: All written submissions received in response to this 
notice must include the agency name (Centers for Disease Control and 
Prevention, HHS) and docket number (CDC-2023-0027, NIOSH-350) for this 
action. All relevant comments, including any personal information 
provided, will be posted without change to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090 
Tusculum Ave., MS C-46, Cincinnati, OH 45226; Telephone (404) 498-2500 
(this is not a toll-free number); Email [email protected].

SUPPLEMENTARY INFORMATION: The WTC Health Program was established by 
Title I of the James Zadroga 9/11 Health and Compensation Act of 2010, 
Public Law 111-347, as amended by Public Law 114-113, Public Law 116-
59, and Public Law 117-328, adding Title XXXIII to the Public Health 
Service (PHS) Act (codified at 42 U.S.C. 300mm--300mm-62). All 
references to the Administrator in this document mean the Director of 
the NIOSH within CDC, or his or her designee.
    The WTC Health Program conducts research among its members 
receiving monitoring or treatment in the Program and in sampled 
populations outside the New York City disaster area (NYCDA), as defined 
in section 3306(7) of the PHS Act, in Manhattan as far north as 14th 
Street and in Brooklyn.\1\
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    \1\ 42 U.S.C. 300mm-51.
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    In December 2022, the Consolidated Appropriations Act, 2023 \2\ 
amended section 3341 of the PHS Act to direct the Administrator, in 
consultation with the Secretary of Education, to establish a new 
research cohort. The cohort must be of sufficient size to conduct 
future research studies on the health and educational impacts of 
``exposure to airborne toxins, or any other hazard or adverse 
condition, resulting from the September 11, 2001, terrorist attacks, 
including on the population of individuals who were 21 years of age or 
younger at the time of exposure, including such individuals who are 
screening-eligible WTC survivors or

[[Page 25407]]

certified-eligible WTC survivors.'' \3\ The new WTC Health Program 
youth research cohort is referred to as ``WTC Youth.'' In accordance 
with section 3341, the cohort of WTC Youth must:
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    \2\ Public Law 117-328 (Dec. 29, 2022).
    \3\ WTC survivors include individuals who lived, worked, went to 
school, or attended child or adult day care in the NYC Disaster Area 
on September 11, 2001, or in the following days, weeks, or months 
and those otherwise meeting the eligibility criteria in 42 CFR 88.7 
or 88.8.
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     Be of sufficient size to conduct future research studies 
on the health and educational impacts of 9/11 exposures;
     Include in this group sufficient representation of 
individuals who were 21 years of age or younger at the time of 
exposure; and
     Include in this group individuals who are screening-
eligible WTC survivors or certified-eligible WTC survivors.
    The cohort may also include individuals who were 21 years of age or 
younger on September 11, 2001, who were located outside the NYCDA and 
in Manhattan not further north than 14th Street; or anywhere within the 
borough of Brooklyn. Additionally, the cohort may include age-
appropriate control populations as needed for research purposes.
    In response to these new requirements, the Administrator, following 
consultation with the Secretary of Education, will engage the public 
for input on a multi-phased approach for establishing the youth cohort. 
At this time, the Administrator seeks initial comments on the following 
approach:
    1. Phase I: Community Engagement: Gather sufficient information 
from educators, scientists, and community members on options for 
establishing a youth cohort that will efficiently support future 
research.
    2. Phase II: Options Development: Use the information gathered in 
Phase I to develop a set of options for moving forward with 
establishing the youth cohort.
    3. Phase III: Options Ranking: Engage community in ranking the 
options developed in Phase II.
    4. Phase IV: Option Selection and Implementation: Use the 
information from Phase III to select the preferred option(s) for 
establishing the youth cohort.

Request for Information

    NIOSH is soliciting information from any interested party, 
including educators, researchers, clinicians, community members, WTC 
Health Program members, treatment providers, and government agencies at 
all levels (Federal, State, Territorial, local, and Tribal), regarding 
the proposed approach to establishing the WTC Health Program youth 
cohort.
    In particular, NIOSH seeks comments on the following items 
regarding the general approach to assembling the cohort, as described 
above:
    1. Whether the four-phased approach for establishing the youth 
cohort is comprehensive and adequately incorporates community 
involvement in selecting a preferred approach for establishing the 
youth cohort.
    2. Any potential partnerships for future actions for establishing 
the cohort of WTC Youth.
    NIOSH also seeks information on the following scientific 
parameters, best practices, and approaches for assembling a research 
cohort that is best suited for future research of WTC Youth:
    3. Ideas regarding outreach, recruitment, retention, community 
involvement, and project oversight. NIOSH is interested in descriptions 
of any anticipated barriers to the project and propose potential risk 
mitigation strategies.
    4. Health conditions and potential social and educational impacts 
(i.e., adverse effects of interest) that may be priorities for future 
research on WTC Youth. In light of these adverse effects to be 
researched, NIOSH is interested in descriptions of the cohort 
characteristics believed necessary to support future research, 
including recommendations on data collection requirements, such as 
describing methods for and frequency of contact with prospective cohort 
members.
    5. The recruitment and retention of appropriate control group(s) 
for future observational studies of WTC Youth. For example, recruitment 
methods may differ between exposed and control groups given expected 
differences in participation rates. These differences may lead to a 
selection bias. A selection bias may also arise given the long period 
of time between exposure and recruitment (i.e., a survivorship bias). 
NIOSH is interested in comments regarding selection of controls using 
methods that reduce the potential for bias in future research.
    Commenters are encouraged to offer information and insights into 
the specific topics described above, or any other aspect of this 
activity.

Disclaimer

    This notice is intended for planning purposes; it does not 
constitute a formal announcement for comprehensive applications. In 
accordance with Federal Acquisition Regulation 48 CFR 15.201(e), 
responses to this notice are not offers and cannot be accepted by the 
Government to form a binding award. NIOSH will not provide 
reimbursement for costs incurred in commenting on this notice.
    NIOSH will not respond to individual public comments or publish 
publicly a compendium of responses. An informational submission in 
response to this notice does not create any commitment by or on behalf 
of CDC or HHS to develop or pursue any program or ideas discussed.

John J. Howard,
Administrator, World Trade Center Health Program and Director, National 
Institute for Occupational Safety and Health, Centers for Disease 
Control and Prevention, Department of Health and Human Services.
[FR Doc. 2023-08756 Filed 4-25-23; 8:45 am]
BILLING CODE 4163-18-P