[Federal Register Volume 88, Number 159 (Friday, August 18, 2023)]
[Notices]
[Pages 56630-56631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17770]


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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; extension of comment period.

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SUMMARY: CDC's National Institute for Occupational Safety and Health 
(NIOSH) is extending the public comment period for a request for 
information (RFI) that published April 26, 2023, regarding a World 
Trade Center (WTC) Health Program research cohort for future studies on 
health, social, and educational impacts among persons exposed to the 
September 11, 2001, terrorist attacks who were aged 21 years or younger 
at the time of their exposures. An organization interested in 
responding to the RFI asked CDC to extend the comment period to allow 
more time to submit comments. With this notice, the comment period is 
extended an additional 60 days, to allow interested parties additional 
time to respond.

DATES: Comments must be received by October 23, 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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[[Page 56631]]

    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 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 NYCDA 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

    In this request for information published in the Federal Register 
(88 FR 25406) on April 26, 2023, 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.
    NIOSH received a request to extend the comment period from an 
organization interested in commenting on the RFI. CDC is extending the 
comment period to allow more time to comment. Accordingly, the comment 
period is extended through October 23, 2023.

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. 2023-17770 Filed 8-17-23; 8:45 am]
BILLING CODE 4163-18-P