Notice2023-08756
World Trade Center Health Program; Youth Research Cohort; Request for Information
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 26, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 80 (Wednesday, April 26, 2023)</title>
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[Federal Register Volume 88, Number 80 (Wednesday, April 26, 2023)]
[Notices]
[Pages 25406-25407]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>
(follow the instructions for submitting comments), or
<bullet> 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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 <a href="/cdn-cgi/l/email-protection#67292e28342f150200142704030449000811"><span class="__cf_email__" data-cfemail="bcf2f5f3eff4ced9dbcffcdfd8df92dbd3ca">[email protected]</span></a>.
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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<bullet> Be of sufficient size to conduct future research studies
on the health and educational impacts of 9/11 exposures;
<bullet> Include in this group sufficient representation of
individuals who were 21 years of age or younger at the time of
exposure; and
<bullet> 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
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