[Federal Register Volume 89, Number 176 (Wednesday, September 11, 2024)]
[Rules and Regulations]
[Pages 73592-73601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20540]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88

[Docket No. CDC-2024-0067; NIOSH-353]
RIN 0920-AA86


World Trade Center (WTC) Health Program; Expanded Eligibility for 
Pentagon and Shanksville, Pennsylvania Responders

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

ACTION: Interim final rule.

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SUMMARY: This interim final rule updates existing regulations governing 
the WTC Health Program, which provides medical monitoring and treatment 
to eligible firefighters and related personnel, law enforcement 
officers, and rescue, recovery, and cleanup workers who responded to 
the September 11, 2001, terrorist attacks in New York City, at the 
Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors 
of the New York City attacks. This rulemaking expands existing 
eligibility criteria for enrollment of new Pentagon and Shanksville 
responders, caps those new members at 500, and makes various conforming 
amendments to the WTC Health Program regulations to align with 
statutory changes.

DATES: This interim final rule will be effective September 11, 2024. 
The WTC Health Program invites written comments from interested parties 
on this interim final rule and on the information collection approval 
request sought under the Paperwork Reduction Act. Comments must be 
received by October 11, 2024.

ADDRESSES: Written comments: Comments, including those related to the 
Paperwork Reduction Act, may be submitted by any of the following 
methods:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments to the docket.
    <bullet> Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 1090

[[Page 73593]]

Tusculum Avenue, Cincinnati, OH 45226.
    Instructions: All submissions received must include the agency name 
(Centers for Disease Control and Prevention, HHS) and docket number 
(CDC-2024-0067; NIOSH-353) or Regulation Identifier Number (0920-AA86) 
for this rulemaking. All relevant comments, including any personal 
information provided, will be posted without change to https://www.regulations.gov. Do not submit comments by email. CDC does not 
accept comments by email. For detailed instructions on submitting 
public comments, see the ``Public Participation'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Public Health Analyst, 
National Institute for Occupational Safety and Health, 1090 Tusculum 
Avenue, 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#7d3334322e350f181a0e3d1e191e531a120b"><span class="__cf_email__" data-cfemail="a5ebeceaf6edd7c0c2d6e5c6c1c68bc2cad3">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

    Interested parties may participate in this rulemaking by submitting 
written views, opinions, recommendations, and data. Comments received, 
including attachments and other supporting materials, are part of the 
public record and subject to public disclosure. Any information in 
comments or supporting materials that is confidential or not intended 
to be disclosed should not be included. CDC will consider the comments 
submitted and may revise the final rule as appropriate.

II. Background

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Zadroga Act), as amended, revised the Public Health Service Act 
(PHS Act) to establish the WTC Health Program (Program), which is 
administered by the National Institute for Occupational Safety and 
Health (NIOSH), within CDC. The WTC Health Program provides medical 
monitoring and treatment to eligible responders to the September 11, 
2001, terrorist attacks in New York City, at the Pentagon, and in 
Shanksville, Pennsylvania, and to eligible survivors of the New York 
City attacks.
    In this interim final rule, the Administrator of the WTC Health 
Program and the Secretary of HHS revise the implementing regulation for 
the Program in a limited manner to only align with the statutory 
changes to the PHS Act. Specifically, the revisions made by this 
rulemaking include expanding eligibility criteria for Pentagon and 
Shanksville responders, adding a numerical limit on Pentagon and 
Shanksville responders enrolled under the new eligibility criteria, 
updating the language in the regulation regarding the numerical limit 
on certain newly enrolled WTC responders and certified-eligible 
survivors, and updating and adding definitions into the WTC Health 
Program regulations in 42 CFR part 88.

A. WTC Health Program Statutory Authority

    Title I of the Zadroga Act \1\ (Pub. L. 111-347, as amended by Pub. 
L. 114-113, Pub. L. 116-59, Pub. L. 117-328, and Pub. L. 118-31) added 
Title XXXIII to the PHS Act, codified at 42 U.S.C. 300mm-300mm-64, 
establishing the WTC Health Program within HHS. The WTC Health Program 
provides medical monitoring and treatment benefits to eligible 
firefighters and related personnel, law enforcement officers, and 
rescue, recovery, and cleanup workers who responded to the September 
11, 2001, terrorist attacks in New York City, at the Pentagon, and in 
Shanksville, Pennsylvania (responders), and to eligible persons who 
were present in the dust or dust cloud on September 11, 2001, or who 
worked, resided, or attended school, childcare, or adult daycare in the 
New York City disaster area (survivors).
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    \1\ Those portions of the Zadroga Act found in titles II and III 
of Public Law 111-347 do not pertain to the WTC Health Program and 
are codified elsewhere.
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    All references to the Administrator in this document mean the 
Director of NIOSH, within CDC, or his or her designee.

B. Regulatory Background

    Following the enactment of the Zadroga Act, the HHS Secretary 
promulgated 42 CFR part 88 to establish the WTC Health Program within 
NIOSH. The Zadroga Act prescribed eligibility criteria for Pentagon and 
Shanksville, Pennsylvania responders and required the Administrator to 
establish the dates on which cleanup was concluded at the Pentagon and 
Shanksville sites, respectively.\2\ The Administrator promulgated the 
eligibility criteria and cleanup dates in 42 CFR 88.4(b) and (c) 
through a rulemaking published on March 28, 2013.\3\ Following the 
rulemaking, eligible Pentagon and Shanksville responders include those 
individuals who:
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    \2\ 42 U.S.C. 300mm-21(a)(2)(C)(i)(I) and (II).
    \3\ World Trade Center Health Program Eligibility Requirements 
for Shanksville, Pennsylvania and Pentagon Responders, Interim Final 
Rule, 78 FR 18855, March 28, 2013.
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    <bullet> Were active or retired members of a fire or police 
department (fire or emergency personnel), worked for a recovery or 
cleanup contractor, or were volunteers; and
    <bullet> Performed rescue, recovery, demolition, debris cleanup, or 
other related services, either at the Pentagon site of the September 
11, 2001, terrorist attacks, for at least 1 day beginning September 11, 
2001, and ending on November 19, 2001, or at the Shanksville, 
Pennsylvania site for at least 1 day beginning September 11, 2001, and 
ending on October 3, 2001.
    Since 2013, the WTC Health Program has enrolled 1,304 Pentagon 
responders and Shanksville, Pennsylvania responders, combined. In 2023, 
Congress identified a gap in coverage for the population of employees 
of the Department of Defense (DOD) or other Federal agencies, certain 
DOD and Federal agency contractors, and regular or reserve uniformed 
service members who responded to the Pentagon and Shanksville sites; 
these personnel have previously not met the statutory eligibility 
criteria in the Zadroga Act due to their specific types of employment.

C. Need for Rulemaking

    The National Defense Authorization Act, 2024 (Pub. L. 118-31, 
December 22, 2023) (2024 NDAA) amended Title XXXIII of the PHS Act to 
expand eligibility criteria for responders to the September 11, 2001, 
terrorist attacks at the Pentagon and in Shanksville, Pennsylvania. The 
new statutory criteria for both sites establish eligibility criteria 
for an individual who:
    <bullet> was an employee of the DOD or any other Federal agency,
    <bullet> worked during the period beginning on September 11, 2001, 
and ending on September 18, 2001, for a contractor of the DOD or any 
other Federal agency, or
    <bullet> was a member of a regular or reserve component of the 
uniformed services.\4\
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    \4\ 42 U.S.C. 300mm-21(a)(2)(C)(i)(III) and (IV).
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    Such individuals must have ``performed rescue, recovery, 
demolition, debris cleanup, or other related services'' during the 
respective cleanup periods at the Pentagon or Shanksville, Pennsylvania 
sites.\5\
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    \5\ The Administrator previously determined that the cleanup 
period at the Pentagon site concluded on November 19, 2001; the 
cleanup period at the Shanksville, Pennsylvania site was determined 
to have concluded on October 3, 2001. 78 FR 18855, March 28, 2013; 
World Trade Center Health Program; Amendments to Definitions, 
Appeals, and Other Requirements, Final Rule, 81 FR 90926, December 
15, 2016.

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[[Page 73594]]

    The 2024 NDAA amendments also define the terms Federal agency and 
uniformed services. A Federal agency is ``[a]n agency, office, or other 
establishment in the executive, legislative, or judicial branch of the 
Federal Government.'' \6\ The uniformed services are ``the armed 
forces; the commissioned corps of the National Oceanic and Atmospheric 
Administration; and the commissioned corps of the Public Health 
Service.'' \7\
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    \6\ 42 U.S.C. 300mm-5(5).
    \7\ 42 U.S.C. 300mm-5(13) adopting by reference the definition 
at 10 U.S.C. 101(a).
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    In addition to the expanded eligibility criteria, the 2024 NDAA 
amendments direct that the total number of Pentagon or Shanksville 
responders who may be enrolled pursuant to the expanded eligibility 
criteria is limited to 500 individuals at any time \8\ and excludes 
these responders from the numerical limitations for newly enrolled 
responders.\9\ Previous amendments to Title XXXIII (Continuing 
Appropriations Act, 2020, and Health Extenders Act of 2019, Pub. L. 
116-59, September 27, 2019) increased the numerical limitations for 
newly enrolled WTC responders and certified-eligible WTC survivors 
enrolled pursuant to the original eligibility criteria \10\ from 25,000 
to 75,000 each.
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    \8\ 42 U.S.C. 300mm-21(a)(4)(A)(ii).
    \9\ 42 U.S.C. 300mm-21(a)(4)(A)(i).
    \10\ For purposes of the numerical limitation, eligibility 
criteria for WTC responders are those newly enrolled responders 
identified in 42 U.S.C. 300mm-21(a)(1)(B)-(C), except FDNY family 
members and the new categories of Pentagon and Shanksville 
responders added by the 2024 NDAA. 42 U.S.C. 300mm-21(a)(4)(A)(i). 
The numerical limitation for certified-eligible WTC survivors 
applies to those newly enrolled survivors identified in 42 U.S.C. 
300mm-31(a)(1)(A)(ii)-(iii) and certified with a WTC-related health 
condition pursuant to 42 U.S.C. 300mm-31(a)(2)(B).
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    In order to operationalize the 2024 NDAA amendments, this 
rulemaking adds the new statutory definitions of the terms Federal 
agency and uniformed services to the existing definitions in 42 CFR 
88.1; expands existing Pentagon and Shanksville, Pennsylvania 
eligibility criteria in Sec.  88.4(b) and (c), respectively; and adds a 
numerical limit for the new population of Pentagon and Shanksville 
responders to Sec.  88.6(c)(2)(ii). Without making these changes to 
part 88, it would not be possible for these responders to enroll and 
participate in the WTC Health Program.
    This rulemaking also makes conforming changes to align part 88 with 
the Zadroga Act, as amended by the Continuing Appropriations Act, 2020, 
and Health Extenders Act of 2019. The numerical limits for certain 
newly enrolled WTC responders and certified-eligible WTC survivors in 
Sec. Sec.  88.6(c)(2)(i) and 88.12(b)(3)(i), respectively, are replaced 
with language indicating that the number of responders or certified-
eligible survivors established may not exceed the limit established in 
the Act. Because the statutory limits were raised in 2019 and 
immediately went into effect, this change is considered non-substantive 
and will not result in any regulatory impact. The existing definitions 
of the terms Act and WTC Health Program are also revised to update the 
statutory references.

D. Issuance of Interim Final Rule With Immediate Effective Date

    Rulemaking is required to update WTC Health Program regulations to 
reflect the 2024 NDAA amendments expanding those groups eligible for 
enrollment as responders at the Pentagon and Shanksville, Pennsylvania 
sites. Once the expanded eligibility criteria are added to 42 CFR part 
88, the WTC Health Program can begin accepting applications from those 
individuals who may qualify for the Program. HHS has determined that an 
interim final rule, rather than a notice of proposed rulemaking, is 
appropriate in this instance to ensure the new eligibility criteria 
expanding enrollment for responders at the Pentagon and Shanksville 
sites may be implemented as soon as possible.
    Moreover, the rulemaking will implement statutory changes required 
by the 2024 NDAA, expanding eligibility as provided by statutory 
changes without exercising discretion or otherwise interpreting 
statutory provisions. As described above, the 2024 NDAA established new 
criteria for responders to the September 11, 2001, terrorist attacks at 
the Pentagon and in Shanksville, Pennsylvania. The NDAA also 
established definitions for the terms Federal agency and uniformed 
services. Finally, the NDAA included a numerical limit of 500 members 
on Pentagon and Shanksville responders enrolled under the new 
eligibility criteria. In this rulemaking, the new statutory criteria 
for Pentagon and Shanksville responders are added to part 88 as are the 
definitions of the terms Federal agency and uniformed services. 
Similarly, the statutory cap of 500 Pentagon and Shanksville members is 
also added to part 88. This rulemaking does not deviate from language 
in the 2024 NDAA.
    Under the Administrative Procedure Act (APA), prior notice and 
comment on a rulemaking may be dispensed with if there is good cause to 
believe that such procedures would be ``impracticable, unnecessary, or 
contrary to the public interest.'' \11\ In this case, the agency 
believes there is good cause to waive prior public participation 
because such procedures are largely unnecessary and would be contrary 
to the public interest in expanding services to certain responders to 
the September 11, 2001, terrorist attacks.
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    \11\ 5 U.S.C. 553(b)(B). Courts differ on whether the good cause 
standard for waiving notice and comment announced in sec. 553(b)(B) 
of the APA is the same standard that should be applied in waiving 
the 30-day publication rule in sec. 553(d). See Cole JP [Jan 2016], 
The Good Cause Exception to Notice and Comment Rulemaking: Judicial 
Review of Agency Action, Congressional Research Service, No. R44356 
at 3-4 (noting that some courts have indicated that these are two 
distinct standards and that the test for good cause to waive notice 
and comment is more stringent than that used to waive the 30-day 
rule).
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    The rulemaking will implement statutory changes required by the 
2024 NDAA and opposition to the expanded eligibility requirements is 
not anticipated. The 2024 NDAA signed into law included language 
expanding eligibility for the WTC Health Program to additional 
responders at the Pentagon and Shanksville sites. The newly eligible 
responders include employees of DOD or other Federal agencies, certain 
DOD and Federal agency contractors, and regular or reserve members of 
the uniformed services. Specifically, the NDAA provided additional 
eligibility for:

    [A]n employee of the Department of Defense or any other Federal 
agency, worked during the period beginning on September 11, 2001, 
and ending on September 18, 2001, for a contractor of the Department 
of Defense or any other Federal agency, or was a member of a regular 
or reserve component of the uniformed services; and performed 
rescue, recovery, demolition, debris cleanup, or other related 
services at the Pentagon site of the terrorist-related aircraft 
crash of September 11, 2001, during the period beginning on 
September 11, 2001, and ending on the date on which the cleanup of 
the site was concluded, as determined by the WTC Program 
Administrator; or
    [A]n employee of the Department of Defense or any other Federal 
agency, worked during the period beginning on September 11, 2001, 
and ending on September 18, 2001, for a contractor of the Department 
of Defense or any other Federal agency, or was a member of a regular 
or reserve component of the uniformed services; and performed 
rescue, recovery, demolition, debris cleanup, or other related 
services at the Shanksville, Pennsylvania, site of the terrorist-
related aircraft crash of September 11, 2001, during the period 
beginning on September 11, 2001, and ending on the date on which the 
cleanup of the site was concluded, as determined by the WTC Program 
Administrator.\12\
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    \12\ Public Law 118-31, div. A, title XVIII, 1851; 137 Stat. 
706, 708.


[[Page 73595]]


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The NDAA also caps the number of new Pentagon and Shanksville 
responders at 500. The rulemaking will only implement statutory changes 
enacted by the NDAA, expanding eligibility as provided by statutory 
changes without exercising discretion or otherwise interpreting 
statutory provisions. As described above, the rulemaking would add 
categories of DOD and other Federal employees and contractors and 
uniformed service members who may be eligible for the WTC Health 
Program and also incorporate the statutory limit on the number of 
additional responders who would be eligible. There is no deviation or 
addition from the statutory language in the regulatory text.
    It would be contrary to the public interest to delay any longer 
than necessary these individuals' eligibility for treatment of health 
conditions that are found to be related to their 9/11 response 
activities. Postponement of the implementation of the new eligibility 
criteria could result in harm to Pentagon and Shanksville responders 
currently coping with one or more health conditions covered by the WTC 
Health Program or who are at risk for developing such a condition. 
Thus, notice and comment procedures should be waived in the interest of 
protecting the health of these responders and allowing them to apply 
for enrollment in the WTC Health Program as soon as possible. No 
opposition to the expanded eligibility requirements is anticipated and 
the agency will not be exercising any discretion in further defining 
certain employees who may be eligible for the Program or clarifying any 
additional limits on the number of individuals from these categories 
who would be eligible. The 2024 NDAA established a new and distinct 
fund to specifically pay for medical monitoring and treatment for this 
new group of responders,\13\ thereby accounting for the anticipated 
costs associated with the expansion. Because this interim final rule 
does not seek to deviate from the 2024 NDAA language and because no 
opposition to this rulemaking is expected, the agency finds that 
notice-and-comment rulemaking is unnecessary and contrary to the public 
interest.
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    \13\ 42 U.S.C. 300mm-64.
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    The APA also requires the publication of a rule ``not less than 30 
days before its effective date,'' unless the agency finds and publishes 
with the rule good cause for such exception.\14\ The same standard for 
establishing ``good cause'' applies to both excepting a rulemaking from 
notice and comment requirements and excepting a rulemaking from the 30-
day post-publication effective date requirement. The ``impracticable'' 
and ``contrary to the public interest'' prongs of the good-cause 
exemption are also satisfied here with respect to waiving the 
requirement for a 30-day post-publication effective date. As elaborated 
further below, the typical delayed effective date would defer the 
agency's ability to provide life-saving treatment and result in less 
favorable outcomes and survival rates for covered individuals. The 
agency expects that Program members who have certified WTC-related 
health conditions experience better treatment outcomes with Program 
physicians as compared with receiving care outside of the Program, 
because of the expertise of Program physicians. Moreover, while other 
insurance plans may require deductibles and copays, which impact access 
to timely care, WTC Health Program members have first-dollar coverage 
and thus may seek care sooner, resulting in improved treatment 
outcomes. Additionally, the ``unnecessary'' prong of the good-cause 
exemption is satisfied because the enactment of the 2024 NDAA provided 
interested parties notice of the changes to the eligibility criteria; 
thus, a delayed effective date is not needed to allow interested 
parties to ready for implementation of the rule.
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    \14\ 5 U.S.C. 553(d).
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    The purpose of the typical post-publication waiting period is to 
give affected parties time to adjust their behavior before the final 
rule takes effect. In this instance, however, the affected parties are 
prospective members of the WTC Health Program who have waited decades 
for medical monitoring and treatment of their WTC-related health 
conditions. The Program anticipates that many prospective members will 
submit applications for enrollment as soon as this rule is effective. 
Such prospective members are already on notice of the statutory changes 
enacted in the 2024 NDAA, and this regulation implements such statutory 
changes without exercising discretion or otherwise interpreting 
statutory provisions. Thus, such prospective members do not require an 
additional 30 days to ready themselves for implementation of this rule. 
Indeed, any delay in effective date could result in postponed medical 
care for such members or require them to pay out of pocket for care in 
the interim. Delayed implementation of the expanded eligibility 
criteria could result in real harm to Pentagon and Shanksville 
responders currently coping with one or more health conditions covered 
by the WTC Health Program or who are at risk for developing such 
conditions. It is in these prospective members' best interest that they 
receive treatment for their WTC-related health conditions as soon as 
possible. Thus, the 30-day post-publication effective date is waived 
for the benefit of these responders to allow them to apply for 
enrollment in the WTC Health Program as soon as possible.
    Moreover, the WTC Health Program does not require additional time 
to prepare for the implementation of this rule. As such, there is no 
public interest served in further delaying the effective date of this 
rulemaking. Public comments on the interim final rule will be 
considered by the Administrator and the regulatory text may be 
modified, as necessary.
    Because it would be contrary to the public interest to delay any 
longer than necessary these individuals' eligibility for treatment of 
health conditions that are found to be related to their 9/11 response 
activities, the Administrator of the WTC Health Program and the HHS 
Secretary find that good cause exists to waive the notice and comment 
requirement and make this rulemaking effective immediately on 
publication. Public comments on the interim final rule will be 
considered by HHS and the Administrator prior to issuance of a final 
rule and the regulatory text may be modified to address comments, as 
necessary. Issuance of a final rule will be noticed in the Federal 
Register.

III. Summary of Final Rule

    With this rulemaking, 42 CFR part 88 is amended as described below.

Authority Citation

    The authority citation for 42 CFR part 88 is updated to reflect 
recent amendments to Title I of the Zadroga Act (Pub. L. 111-347, as 
amended by Pub. L. 114-113, Pub. L. 116-59, Pub. L. 117-328, and Pub. 
L. 118-31). The statutory citation now reads 42 U.S.C. 300mm-300mm-64.

Section 88.1 Definitions

    The statutory definitions of the terms Federal agency and uniformed 
services are added to the existing Definitions section, 42 CFR 88.1. In 
the existing definitions of Act and WTC Health Program, the statutory 
authority is updated to reflect recent amendments to the Zadroga Act.

Section 88.4 Eligibility Criteria--WTC Responders

    The existing Pentagon responder eligibility criteria in 42 CFR 
88.4(b) are modified to include the new statutory

[[Page 73596]]

criteria for the three new classes of eligible responders at the 
Pentagon site. For clarity, the existing language in paragraph (b)(1) 
is broken into new paragraphs, designated (b)(1)(i) through (iii). New 
paragraph (b)(1)(iv) identifies employees of the DOD or any other 
Federal agency; paragraph (b)(1)(v) identifies employees of DOD 
contractors or other Federal agency contractors who worked during the 
period beginning on September 11, 2001, and ending on September 18, 
2001; and paragraph (b)(1)(vi) identifies members of regular and 
reserve components of the uniformed services. Language in existing 
Sec.  88.4(b)(2) describing eligible response activities, time periods, 
and duration of work is split into two paragraphs, resulting in a new 
paragraph (b)(3).
    The existing Shanksville, Pennsylvania responder eligibility 
criteria in Sec.  88.4(c) are also revised to add the new statutory 
criteria for the three new classes of eligible responders at the 
Shanksville, Pennsylvania site. For clarity, the existing language in 
paragraph (c)(1) is broken into new paragraphs, designated (c)(1)(i) 
through (iii). New paragraph (c)(1)(iv) identifies employees of the DOD 
or any other Federal agency; paragraph (c)(1)(v) identifies employees 
of DOD contractors or other Federal agency contractors who worked 
during the period beginning on September 11, 2001, and ending on 
September 18, 2001; and paragraph (c)(1)(vi) identifies members of 
regular and reserve components of the uniformed services. Language in 
existing paragraph (c)(2) describing eligible response activities, time 
periods, and duration of work is split into two paragraphs, resulting 
in a new paragraph (c)(3).

Section 88.6 Enrollment Decision--WTC Responders

    In 42 CFR 88.6, existing paragraph (c) establishes conditions under 
which the WTC Health Program may deny enrollment of responders. In 
paragraph (c)(2)(i), the numerical limit on new WTC responder 
enrollment is replaced with new language indicating that this limit is 
established in the Zadroga Act, as amended. Language in paragraph 
(c)(2)(i) describing the Administrator's discretion regarding whether 
to close Program enrollment in the event that sufficient funds are not 
available to enroll new members is moved to a new paragraph (c)(2)(iii) 
without change. New text in paragraph (c)(2)(ii) reflects the new 
statutory limit of 500 total WTC responders who may be enrolled 
pursuant to the expanded Pentagon and Shanksville, Pennsylvania 
eligibility criteria in Sec. Sec.  88.4(b)(1)(iv) through (vi) and 
88.4(c)(1)(iv) through (vi), respectively.

Section 88.12 Enrollment Decision--Certified-Eligible Survivors

    In 42 CFR 88.12, existing paragraph (b)(3) establishes conditions 
under which the WTC Health Program may deny certified-eligible survivor 
status. The numerical limit in paragraph (b)(3)(i) is replaced with new 
language indicating that the limit on certified-eligible survivor 
enrollment is specified in the Zadroga Act, as amended. Language in 
existing paragraph (b)(3)(i), describing the Administrator's discretion 
regarding whether to close Program enrollment in the event that 
sufficient funds are not available to enroll new members, is moved to a 
new paragraph (b)(3)(ii) without change.

IV. Regulatory Impact Analysis

A. Executive Order 12866 (Regulatory Planning and Review), Executive 
Order 13563 (Improving Regulation and Regulatory Review), and Executive 
Order 14094 (Modernizing Regulatory Review)

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 14094 entitled ``Modernizing Regulatory Review'' amends section 
3(f)(1) of Executive Order 12866 (Regulatory Planning and Review). The 
amended section 3(f) of Executive Order 12866 defines a ``significant 
regulatory action'' as an action that is likely to result in a rule: 
(1) having an annual effect on the economy of $200 million or more 
(adjusted every 3 years by the Administrator of the Office of 
Management and Budget's Office of Information and Regulatory Affairs 
(OIRA) for changes in gross domestic product), or adversely affect in a 
material way the economy, a sector of the economy, productivity, 
competition, jobs, the environment, public health or safety, or State, 
local, territorial, or Tribal governments or communities; (2) creating 
a serious inconsistency or otherwise interfering with an action taken 
or planned by another agency; (3) materially altering the budgetary 
impacts of entitlement grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) raising legal or 
policy issues for which centralized review would meaningfully further 
the President's priorities or the principles set forth in this 
Executive order, as specifically authorized in a timely manner by the 
Administrator of OIRA in each case. A regulatory impact analysis (RIA) 
must be prepared for major rules with significant regulatory action/s 
and/or with significant effects as per section 3(f)(1) ($200 million or 
more in any 1 year).
    This interim final rule has been determined not to be a significant 
regulatory action under section 3(f)(1) of Executive Order 12866 and 
does not meet the criteria set forth in 5 U.S.C. 804(2) under subtitle 
E of the Small Business Regulatory Enforcement Fairness Act of 1996 
(also known as the Congressional Review Act). This rulemaking expands 
the existing eligibility criteria for the enrollment of Pentagon and 
Shanksville responders to also include employees of the DOD or any 
other Federal agency, certain DOD and Federal agency contractors, and 
regular or reserve members of the uniformed services who meet the 
activity, location, and time criteria specified in the statutory 
amendments. The rulemaking implements the statutory cap of 500 on the 
total number of Pentagon and Shanksville responders enrolled under 
those expanded criteria.
    The 2024 NDAA allows for the addition of up to 500 new Program 
members to be enrolled under the expanded eligibility criteria for 
individuals who responded to the September 11, 2001, terrorist attack 
sites at the Pentagon in Arlington, Virginia, and in Shanksville, 
Pennsylvania, pursuant to 42 U.S.C. 300mm-21(a)(4)(A)(ii). In 
accordance with sec. 300mm-64(c)(1), costs associated with carrying out 
medical monitoring, diagnostics, screening, and treatment, including 
non-pharmacy and pharmacy costs, for the 500 new members are to be paid 
out of a newly established World Trade Center Health Program Fund for 
Certain WTC Responders at the Pentagon and Shanksville, Pennsylvania. 
For that reason, this analysis accounts only for those costs associated 
with medical monitoring, diagnostics, screening, and non-pharmacy 
treatment (medical costs) and pharmacy costs; WTC Health Program 
administrative costs are not included in the analysis.
    Historical WTC Health Program claims data were used to project the 
costs associated with the future enrollment of 500 potential new 
Pentagon and Shanksville responder members under the expanded 
eligibility criteria. These historical data account for variables 
including an aging member

[[Page 73597]]

population, healthcare utilization, co-morbidities, and inflation; 
incorporation of these variables results in projected per-member costs 
increasing year-over-year.
    This analysis started from the premise that all 500 future Pentagon 
and Shanksville members will enroll in the Program within 5 years of 
this rulemaking. To estimate the rate of enrollment over 5 years, this 
analysis further assumed that fiscal year (FY) 2024 enrollment will be 
relatively low, given the timing of this rulemaking. New enrollments 
could peak in the first and second full fiscal years (FY2025/2026 if 
enrollment starts in FY2024) and likely level off in later years. Given 
these assumptions, the new enrollments for this group were estimated 
for each fiscal year from FY2024 through FY2028; after the FY2024 
estimate, each subsequent annual estimate was then added to the 
enrollment from the prior fiscal year to estimate the total number of 
members in the expanded eligibility category for each fiscal year in 
table 1.

    Table 1--Projected Annual New Pentagon and Shanksville Responder
      Enrollments Under Expanded Eligibility Criteria, FY2024-2028
------------------------------------------------------------------------
                                           Projected new  Cumulative new
                   FY                       enrollment      enrollment
------------------------------------------------------------------------
2024....................................              30              30
2025....................................             150             180
2026....................................             120             300
2027....................................             100             400
2028....................................             100             500
                                         -------------------------------
    Total...............................             500  ..............
------------------------------------------------------------------------

    The Program next estimated the future annual medical and pharmacy 
costs associated with 500 new Pentagon and Shanksville responder 
members enrolled over 5 years, from FY2024 through FY2028. This 
analysis assumed that individuals enrolled under the expanded 
eligibility criteria would have similar average medical costs and 
pharmacy costs as Pentagon and Shanksville responders enrolled under 
the current eligibility criteria. This analysis does not include 
administrative costs associated with the addition of future members.
    To estimate the future costs associated with the enrollment of 500 
new members, this analysis first found the average per-member medical 
costs, pharmacy costs, and total costs for Pentagon and Shanksville 
responders enrolled under the current eligibility criteria. To do so, 
first, future enrollment and annual medical costs, pharmacy costs, and 
total costs were projected for the current Pentagon and Shanksville 
responders through FY2028. See table 2.

  Table 2--Projected Enrollment and Associated Medical and Pharmacy Costs for Current Pentagon and Shanksville
                                             Responders, FY2024-2028
                                                     [2024$]
----------------------------------------------------------------------------------------------------------------
                                 Total projected number
                                of Pentagon/Shanksville   Projected total    Projected total    Total projected
              FY                  responders, current      medical costs      pharmacy costs         costs
                                  eligibility criteria
----------------------------------------------------------------------------------------------------------------
2024..........................                    1,391         $3,061,444         $1,722,479         $4,783,923
2025..........................                    1,513          3,547,280          1,966,896          5,514,176
2026..........................                    1,636          4,033,115          2,211,313          6,244,428
2027..........................                    1,758          4,518,950          2,455,731          6,974,681
2028..........................                    1,880          5,004,785          2,700,148          7,704,933
                               ---------------------------------------------------------------------------------
    Total.....................  .......................         20,165,574         11,056,567         31,222,141
----------------------------------------------------------------------------------------------------------------

    Next, the projected medical costs and projected pharmacy costs were 
divided by the projected number of Pentagon and Shanksville responder 
members under the current eligibility criteria (table 2) to calculate 
the estimated average per member medical costs and pharmacy costs for 
each projected year from FY2024 through FY2028. The total cost per 
member was then calculated by summing the per member medical and 
pharmacy costs for each fiscal year. See table 3.

Table 3--Projected Medical and Pharmacy Costs per Current Pentagon and Shanksville Responder Member, FY2024-2028
                                                     [2024$]
----------------------------------------------------------------------------------------------------------------
                                                                     Projected       Projected         Total
                               FY                                  medical costs  pharmacy costs  projected cost
                                                                    per member      per member      per member
----------------------------------------------------------------------------------------------------------------
2024............................................................          $2,201          $1,238          $3,439

[[Page 73598]]

 
2025............................................................           2,345           1,300           3,645
2026............................................................           2,465           1,352           3,817
2027............................................................           2,571           1,397           3,968
2028............................................................           2,662           1,436           4,098
----------------------------------------------------------------------------------------------------------------

    Next, the projected medical costs and pharmacy costs for new 
Pentagon and Shanksville responders were calculated for FY2024 through 
FY2028 by multiplying the predicted costs per current Pentagon and 
Shanksville responder for each fiscal year from table 3 by the 
projected cumulative number of new members enrolled under the expanded 
eligibility criteria for each fiscal year from table 1. The analysis 
concluded that the projected medical and pharmacy costs for 500 
Pentagon and Shanksville responders enrolled under the expanded 
eligibility criteria will be $5,540,570 (undiscounted) over 5 years. 
See table 4.

      Table 4--Projected Medical and Pharmacy Costs, New Pentagon and Shanksville Responders Under Expanded
                                        Eligibility Criteria, FY2024-2028
                                                     [2024$]
----------------------------------------------------------------------------------------------------------------
                                          Projected                             Projected
                 FY                     cumulative new   Projected medical  pharmacy cost for   Projected total
                                          enrollment      costs for cohort        cohort        cost for cohort
----------------------------------------------------------------------------------------------------------------
2024................................                 30            $66,030            $37,140           $103,170
2025................................                180            422,100            234,000            656,100
2026................................                300            739,500            405,600          1,145,100
2027................................                400          1,028,400            558,800          1,587,200
2028................................                500          1,331,000            718,000          2,049,000
                                     ---------------------------------------------------------------------------
    Total...........................  .................          3,587,030          1,953,540          5,540,570
----------------------------------------------------------------------------------------------------------------

    The total projected costs associated with the expansion of the 
Pentagon and Shanksville eligibility criteria for each fiscal year, 
from table 4, were discounted at the 2 percent rate to reflect changes 
in the valuation of the impacts of this rulemaking across time. In 
table 5, the total medical and pharmacy costs were projected to be 
between $5,132,395 (discounted at 2%) and $5,540,570 (undiscounted) 
over 5 years. The discounted and undiscounted 5-year totals were 
divided by 5 to find the projected average annual costs from $1,026,479 
(discounted at 2%) to $1,108,144 (undiscounted). The projected total 
medical and pharmacy costs described here may be overstated if the 
total number of Pentagon and Shanksville responders enrolled pursuant 
to the expanded eligibility criteria is fewer than 500 members.

  Table 5--Total Projected Medical and Pharmacy Costs, New Pentagon and
 Shanksville Responders Under Expanded Eligibility Criteria, FY2024-2028
                                 [2024$]
------------------------------------------------------------------------
                FY                     Undiscounted      Discounted 2%
------------------------------------------------------------------------
2024..............................           $103,170  .................
2025..............................            656,100           $643,240
2026..............................          1,145,100          1,100,670
2027..............................          1,587,200          1,495,619
2028..............................          2,049,000          1,892,866
    Total.........................          5,540,570          5,132,395
        Annualized................          1,108,144          1,026,479
------------------------------------------------------------------------

    Since the implementation of provisions of the Patient Protection 
and Affordable Care Act on January 1, 2014, all WTC Health Program 
members and future members are assumed to have or have had access to 
medical insurance coverage other than through the WTC Health 
Program.\15\ Therefore, all medical and pharmacy costs to be paid by 
the WTC Health Program from 2024 through 2028 are considered transfers.
---------------------------------------------------------------------------

    \15\ 42 U.S.C. 300mm-41(c)(3) requires WTC Health Program 
members to maintain minimum essential insurance coverage.
---------------------------------------------------------------------------

Benefits
    The Administrator of the WTC Health Program does not have 
information on the health of the population that may

[[Page 73599]]

have experienced 9/11 exposures and is not currently enrolled in the 
WTC Health Program. In addition, the Administrator has only limited 
information about health insurance and healthcare services available 
for WTC-related health conditions potentially caused by 9/11 exposures 
and suffered by any population of responders and survivors who are not 
currently enrolled. For the purposes of this analysis, the 
Administrator assumed that all unenrolled responders and survivors are 
now covered by health insurance due to access provided by the Patient 
Protection and Affordable Care Act and may be receiving treatment 
outside the WTC Health Program.
    Although the Administrator cannot quantify the benefits associated 
with the WTC Health Program, members with certified WTC-related health 
conditions are expected to experience better treatment outcomes with 
WTC Health Program providers as compared to receiving care outside of 
the WTC Health Program. A recent study found that firefighters who 
responded to the September 11, 2001, terrorist attacks, have lower 
mortality rates compared with firefighters who were not 9/11-exposed. 
The authors attributed that finding, in part, to the level of care, 
including comprehensive health monitoring and treatment, provided to 
WTC Health Program members.\16\ Moreover, under other insurance plans, 
patients would likely have deductibles and copays, which impact access 
to care and, particularly, its timeliness.\17\ WTC Health Program 
members have first-dollar coverage and hence are likely to seek care 
sooner, when indicated, resulting in improved treatment outcomes.
---------------------------------------------------------------------------

    \16\ Singh A, Zeig-Owens R, Cannon M, Webber MP, Goldfarb DG, 
Daniels RD, Prezant DJ, Boffetta P, Hall CB [2023], All-Cause and 
Cause-Specific Mortality in a Cohort of WTC-Exposed and Non-WTC-
Exposed Firefighters, Occup Environ Med 0:1-7.
    \17\ Wharam JF, Galbraith AA, Kleinman KP, Soumerai SB, Ross-
Degnan D, Landon BE [2008], Cancer Screening before and after 
Switching to a High-Deductible Health Plan, Ann Intern Med 
148(9):647-655.
---------------------------------------------------------------------------

Limitations
    The analysis presented here was limited by the dearth of verifiable 
data on the health status of responders and survivors who have yet to 
apply for enrollment in the WTC Health Program. Because of the limited 
data, the Administrator is not able to estimate benefits in terms of 
averted healthcare costs; nor is the Administrator able to estimate 
indirect costs, such as averted absenteeism, short- and long-term 
disability, and productivity losses averted due to premature mortality.
Alternatives
    The sole alternative to adding the new statutory enrollment 
eligibility criteria to the regulations in 42 CFR part 88 is to not add 
the criteria. In the instant case, neither the Administrator of the WTC 
Health Program nor the HHS Secretary have discretion in this matter 
because Congress has directed the specific regulatory outcome--the 
addition of up to 500 new Pentagon and Shanksville responders--in the 
2024 NDAA amendments. Without conducting rulemaking, even though the 
statutory language establishes expanded eligibility criteria for the 
enrollment of new Pentagon and Shanksville responders, these 
individuals would not fall within the scope of the WTC Health Program 
regulations in 42 CFR part 88. Without eligibility criteria specified 
in part 88, these individuals could not be enrolled as members in the 
Program and would not be subject to Program regulations and policies.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., as 
amended by the Small Business Regulatory Enforcement Fairness Act 
(SBREFA), requires each agency to consider the potential impact of its 
regulations on small entities, including small businesses, small 
governmental units, and small not-for-profit organizations. Section 605 
of U.S.C. title 5 allows an agency to certify a rule, in lieu of 
preparing an analysis, if the rulemaking is not expected to have a 
significant economic impact on a substantial number of small entities. 
The Secretary certifies that this interim final rule has ``no 
significant economic impact upon a substantial number of small 
entities'' within the meaning of the RFA.

C. Paperwork Reduction Act

    The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires 
an agency to invite public comment on, and to obtain Office of 
Management and Budget (OMB) approval of, any regulation that requires 
10 or more people to report information to the agency or to keep 
certain records. OMB has already approved the information collection 
and recordkeeping requirements in OMB Control Number 0920-0891, World 
Trade Center Health Program Enrollment, Petitions, Designated 
Representative/HIPAA Authorization, and Member Satisfaction (expiration 
date September 30, 2025). To account for increases in responses and 
burden associated with this rulemaking without delay, HHS is requesting 
emergency review and clearance for the updating of the WTC Health 
Program Pentagon and Shanksville, Pennsylvania, responders' enrollment 
application form. A description of the relevant regulatory provision is 
given below with an estimate of the annual reporting burden. Included 
in the estimate of the annual reporting burden is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information. In compliance with the requirement of 44 
U.S.C. 3506(c)(2)(A) for opportunity for public comment on proposed 
data collection projects, written comments are encouraged on this 
information collection. To request more information on the proposed 
project or to obtain a copy of the data collection plans and 
instruments, you may call 404-639-5960; send comments to Jeffrey M. 
Zirger, 1600 Clifton Road, MS-H21, Atlanta, GA 30333; or send an email 
to <a href="/cdn-cgi/l/email-protection#06696b644665626528616970"><span class="__cf_email__" data-cfemail="1976747b597a7d7a377e766f">[email protected]</span></a>.
    Comments are invited on the following: (a) Whether the proposed 
collection of information is necessary for the proper performance of 
the functions of the Agency, including whether the information shall 
have practical utility; (b) the accuracy of the Agency's estimate of 
the burden of the proposed collection of information; (c) ways to 
enhance the quality, utility, and clarity of the information to be 
collected; and (d) ways to minimize the burden of the collection of 
information on respondents. Written comments should be received within 
30 days of the publication of this document.
    This interim final rule allows the WTC Health Program to extend 
membership to individuals who meet the expanded eligibility criteria 
codified in 42 CFR 88.4 by this rulemaking. The Program has revised the 
existing Pentagon/Shanksville eligibility application to include the 
expanded criteria and is increasing the burden in the approved 
collection of information to account for up to 500 additional 
enrollment applications. This emergency information collection request 
is for 250 annual burden hours.

[[Page 73600]]



--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                              Average     Average burden
                    Section                                       Title                      Number of     responses per   per response    Total burden
                                                                                            respondents     respondent         (hr)            (hr)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   88.4....................................  World Trade Center Health Program                   500               1             0.5             250
                                                  Pentagon/Shanksville Responder
                                                  Application for Enrollment.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The agency will submit the adjustment in burden for OMB Control No. 
0920-0891 to OMB for its emergency review and approval.

D. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 
U.S.C. 1531 et seq.) directs agencies to assess the effects of Federal 
regulatory actions on State, local, and Tribal governments, and on the 
private sector ``other than to the extent that such regulations 
incorporate requirements specifically set forth in law.'' Section 202 
of U.S.C. title 2 also requires that agencies assess anticipated costs 
and benefits before issuing any rule whose mandates require spending in 
any 1 year of $100 million in 1995 dollars, updated annually for 
inflation. In 2024, that threshold is approximately $183 million. This 
interim final rule does not mandate any requirements for State, local, 
or Tribal governments, or for the private sector, and this rule does 
not impose a mandate that will result in the expenditure by State, 
local, and Tribal governments, in the aggregate, or by the private 
sector, of more than $183 million in any 1 year.

E. Executive Order 12988 (Civil Justice Reform)

    This interim final rule has been drafted and reviewed in accordance 
with Executive Order 12988 and will not unduly burden the Federal court 
system. This interim final rule has been reviewed carefully to 
eliminate drafting errors and ambiguities.

F. Executive Order 13132 (Federalism)

    HHS has reviewed this interim final rule in accordance with 
Executive Order 13132 regarding federalism and has determined that it 
does not have ``federalism implications.'' The rule does not ``have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government.''

G. Executive Order 13045 (Protection of Children From Environmental 
Health Risks and Safety Risks)

    In accordance with Executive Order 13045, HHS has evaluated the 
environmental health and safety effects of this interim final rule on 
children. HHS has determined that the interim final rule has no 
environmental health and safety effect on children.

H. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)

    In accordance with Executive Order 13211, HHS has evaluated the 
effects of this interim final rule on energy supply, distribution, or 
use, and has determined that the rule will not have a significant 
adverse effect.

I. Plain Writing Act of 2010

    Under the Plain Writing Act of 2010, 5 U.S.C. 301 note, executive 
Departments and Agencies are required to use plain language in 
documents that explain to the public how to comply with a requirement 
the Federal Government administers or enforces. HHS has attempted to 
use plain language in issuing this rulemaking consistent with the 
Federal Plain Writing Act guidelines but notes that these standards are 
technical in nature.

List of Subjects in 42 CFR Part 88

    Aerodigestive disorders, Appeal procedures, Cancer, Eligibility 
criteria, Health care, Mental health conditions, Musculoskeletal 
disorders, Respiratory and pulmonary diseases, World Trade Center.

    For the reasons discussed in the preamble, the Administrator and 
HHS Secretary amend 42 CFR part 88 as follows:

PART 88--WORLD TRADE CENTER HEALTH PROGRAM

0
1. The authority citation for part 88 is revised to read as follows:

    Authority:  42 U.S.C. 300mm to 300mm-64.


0
2. Amend Sec.  88.1 by:
0
a. Revising the definition for ``Act'';
0
b. Adding the definitions for ``Federal agency'' and ``Uniformed 
services'' in alphabetical order; and
0
c. Revising the definition for ``WTC Health Program''.
    The revisions and additions read as follows:


Sec.  88.1  Definitions.

    Act means Title XXXIII of the Public Health Service Act, as 
amended, 42 U.S.C. 300mm through 300mm-64 (codifying Title I of the 
James Zadroga 9/11 Health and Compensation Act of 2010, Pub. L. 111-
347, as amended by Pub. L. 114-113, Pub. L. 116-59, Pub. L. 117-328, 
and Pub. L. 118-31), which created the World Trade Center (WTC) Health 
Program.
* * * * *
    Federal agency means an agency, office, or other establishment in 
the executive, legislative, or judicial branch of the Federal 
Government.
* * * * *
    Uniformed services means the armed forces, the commissioned corps 
of the National Oceanic and Atmospheric Administration, and the 
commissioned corps of the Public Health Service.
* * * * *
    WTC Health Program means the program established by Title XXXIII of 
the Public Health Service Act, as amended, 42 U.S.C. 300mm to 300mm-64 
(codifying Title I of the James Zadroga 9/11 Health and Compensation 
Act of 2010, Pub. L. 111-347, as amended by Pub. L. 114-113, Pub. L. 
116-59, Pub. L. 117-328, and Pub. L. 118-31) to provide medical 
monitoring and treatment benefits for eligible responders to the 
September 11, 2001, terrorist attacks and initial health evaluation, 
monitoring, and treatment benefits for residents and other building 
occupants and area workers in New York City who were directly impacted 
and adversely affected by such attacks.
* * * * *

0
3. Amend Sec.  88.4, by revising paragraphs (b) and (c) to read as 
follows:


Sec.  88.4  Eligibility criteria--WTC responders.

* * * * *
    (b) Responders to the Pentagon site of the September 11, 2001, 
terrorist attacks, may apply for enrollment in the WTC Health Program. 
Individuals must meet the criteria in paragraphs (b)(1) through (3) of 
this section to be considered eligible for enrollment.

[[Page 73601]]

    (1) The individual was one of the following:
    (i) An active or retired member of a fire or police department 
(fire or emergency personnel);
    (ii) Worked for a recovery or cleanup contractor;
    (iii) A volunteer;
    (iv) An employee of the Department of Defense or any other Federal 
agency;
    (v) Worked for a contractor of the Department of Defense or any 
other Federal agency during the period beginning on September 11, 2001, 
and ending on September 18, 2001; or
    (vi) A member of a regular or reserve component of the uniformed 
services;
    (2) The individual performed rescue, recovery, demolition, debris 
cleanup, or other related services at the Pentagon site of the 
September 11, 2001, terrorist attacks; and
    (3) The individual performed the activities in paragraph (b)(2) of 
this section for at least 1 day beginning September 11, 2001, and 
ending on November 19, 2001.
    (c) Responders to the Shanksville, Pennsylvania site of the 
September 11, 2001, terrorist attacks, may apply for enrollment in the 
WTC Health Program. Individuals must meet the criteria in paragraphs 
(c)(1) through (3) of this section to be considered eligible for 
enrollment:
    (1) The individual was one of the following:
    (i) An active or retired member of a fire or police department 
(fire or emergency personnel);
    (ii) Worked for a recovery or cleanup contractor;
    (iii) A volunteer;
    (iv) An employee of the Department of Defense or any other Federal 
agency;
    (v) Worked for a contractor of the Department of Defense or any 
other Federal agency during the period beginning on September 11, 2001, 
and ending on September 18, 2001; or
    (vi) A member of a regular or reserve component of the uniformed 
services;
    (2) The individual performed rescue, recovery, demolition, debris 
cleanup, or other related services at the Shanksville, Pennsylvania 
site of the September 11, 2001, terrorist attacks; and
    (3) The individual performed the activities in paragraph (c)(2) of 
this section for at least 1 day beginning September 11, 2001, and 
ending on October 3, 2001.
* * * * *

0
4. Amend Sec.  88.6, by revising paragraph (c)(2) to read as follows:


Sec.  88.6  Enrollment decision--WTC responders.

* * * * *
    (c) * * *
    (2) The WTC Health Program may deny enrollment of a responder who 
is otherwise eligible and qualified if the Act's numerical limitations 
for newly enrolled responders have been met.
    (i) No more than the number of WTC responders specified in the Act, 
as amended, other than those enrolled pursuant to Sec. Sec.  88.3, 
88.4(a)(1)(ii), 88.4(b)(1)(iv) through (vi), and 88.4(c)(1)(iv) through 
(vi), may be enrolled at any time.
    (ii) No more than 500 WTC responders meeting the eligibility 
criteria in Sec. Sec.  88.4(b)(1)(iv) through (vi) and 88.4(c)(1)(iv) 
through (vi) may be enrolled at any time.
    (iii) The Administrator of the WTC Health Program may decide, based 
on the best available evidence, that sufficient funds are available 
under the Act to provide treatment and monitoring only for individuals 
who are already enrolled as WTC responders at that time.
* * * * *

0
5. Amend Sec.  88.12, by revising paragraphs (b) introductory text and 
(b)(3) to read as follows:


Sec.  88.12  Enrollment decision--certified-eligible survivors.

* * * * *
    (b) The WTC Health Program will review the physician's 
determination, render a decision regarding certification of the 
individual's WTC-related health condition, and notify the individual of 
the decision and the reason for the decision in writing, pursuant to 
Sec. Sec.  88.17 and 88.18.
* * * * *
    (3) The WTC Health Program may deny certified-eligible survivor 
status of an otherwise eligible and qualified screening-eligible 
survivor if the Act's numerical limitations for certified-eligible 
survivors have been met.
    (i) No more than the number of individuals specified in the Act, as 
amended, other than those described in Sec.  88.7, may be determined to 
be certified-eligible survivors at any time.
    (ii) The Administrator of the WTC Health Program may decide, based 
on the best available evidence, that sufficient funds are available 
under the Act to provide treatment and monitoring only for individuals 
who have already been certified as certified-eligible survivors at that 
time.
* * * * *

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.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-20540 Filed 9-10-24; 8:45 am]
BILLING CODE 4165-18-P


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