World Trade Center Health Program; Youth Research Cohort; Request for Information, 56630-56631 [2023-17770]
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Federal Register / Vol. 88, No. 159 / Friday, August 18, 2023 / Notices
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SUMMARY:
VerDate Sep<11>2014
18:26 Aug 17, 2023
Jkt 259001
Centers for Disease Control and
Prevention
[Docket No. CDC–2023–0027, NIOSH–350]
World Trade Center Health Program;
Youth Research Cohort; Request for
Information
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Request for information;
extension of comment period.
AGENCY:
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
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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.
Comments must be received by
October 23, 2023.
ADDRESSES: Comments may be
submitted through either of the
following two methods:
• Federal eRulemaking Portal: https://
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 https://
www.regulations.gov.
DATES:
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
NIOSHregs@cdc.gov.
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
1 42
E:\FR\FM\18AUN1.SGM
U.S.C. 300mm–51.
18AUN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 159 / Friday, August 18, 2023 / Notices
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:
• 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
2 Public
Law 117–328 (Dec. 29, 2022).
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.
3 WTC
VerDate Sep<11>2014
18:26 Aug 17, 2023
Jkt 259001
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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
56631
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]
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://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\
---------------------------------------------------------------------------
\1\ 42 U.S.C. 300mm-51.
---------------------------------------------------------------------------
[[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:
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
