World Trade Center Health Program; Addition of Prostate Cancer to the List of WTC-Related Health Conditions, 57505-57523 [2013-22800]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 78, Number 182 (Thursday, September 19, 2013)]
[Rules and Regulations]
[Pages 57505-57523]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22800]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88

[Docket No. CDC-2013-0012; NIOSH-267]
RIN 0920-AA54


World Trade Center Health Program; Addition of Prostate Cancer to 
the List of WTC-Related Health Conditions

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Final rule.

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SUMMARY: On May 2, 2013, the Administrator of the World Trade Center 
(WTC) Health Program received a petition (Petition 002) requesting the 
addition of prostate cancer to the List of WTC-Related Health 
Conditions (List) covered in the WTC Health Program. In this final 
rule, the Administrator adds malignant neoplasm of the prostate 
(prostate cancer) to the List in the WTC Health Program regulations.

DATES: This final rule is effective October 21, 2013.

FOR FURTHER INFORMATION CONTACT: Paul Middendorf, Senior Health 
Scientist, 1600 Clifton Rd. NE., MS: E-20, Atlanta, GA 30329; telephone 
(404) 498-2500 (this is not a toll-free number); email 
pmiddendorf@cdc.gov.

SUPPLEMENTARY INFORMATION: This preamble is organized as follows:

I. Executive Summary
    A. Purpose of Regulatory Action
    B. Summary of Major Provisions
    C. Costs and Benefits
II. Public Participation
III. Background
    A. WTC Health Program Statutory Authority
    B. Methods Used by the Administrator To Determine Whether To Add 
Cancer or Types of Cancer to the List of WTC-Related Health 
Conditions
    C. Consideration of Evidence for Adding Prostate Cancer to the 
List
IV. Administrator's Determination on Petition 002 Requesting the 
Addition of Prostate Cancer to the List
V. Early Detection of Prostate Cancer
VI. Effects of Rulemaking on Federal Agencies
VII. Summary of Final Rule and Response to Public Comments
VIII. Regulatory Assessment Requirements
    A. Executive Order 12866 and Executive Order 13563
    B. Regulatory Flexibility Act
    C. Paperwork Reduction Act
    D. Small Business Regulatory Enforcement Fairness Act
    E. Unfunded Mandates Reform Act of 1995
    F. Executive Order 12988 (Civil Justice)
    G. Executive Order 13132 (Federalism)
    H. Executive Order 13045 (Protection of Children From 
Environmental Health Risks and Safety Risks)
    I. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)
    J. Plain Writing Act of 2010

I. Executive Summary

A. Purpose of Regulatory Action

    This rulemaking is being conducted in response to a petition to the 
Administrator of the WTC Health Program by the Patrolmen's Benevolent 
Association, a union representing New York City police officers 
(Petition 002). The petition asks that the Administrator add prostate 
cancer to the List of WTC-Related Health Conditions citing a study of 
over 25,000 WTC responders enrolled in the WTC Health Program as 
scientific evidence.

B. Summary of Major Provisions

    The rule adds prostate cancer to the cancers identified in 42 CFR 
88.1, Table 1 as covered by the WTC Health Program for treatment and 
monitoring.

C. Costs and Benefits

    The addition of prostate cancer by this rulemaking is estimated to 
cost the WTC Health Program between $3,462,675 and $6,995,817 per 
annum. All of the costs to the WTC Health Program will be transfers 
after the implementation of provisions of the Patient Protection and 
Affordable Care Act (Pub. L. 111-148) on January 1, 2014.

II. Public Participation

    On July 2, 2013, the Administrator of the WTC Health Program 
published a notice of proposed rulemaking (78 FR 39670) proposing to 
add prostate cancer (malignant neoplasm of the prostate) to the List of 
WTC-Related Health Conditions. The Administrator invited interested 
persons or organizations to participate in this rulemaking by 
submitting written views, opinions, recommendations, and/or data. 
Comments were invited on any topic related to the proposed rule.
    The Administrator received 11 substantive submissions to the docket 
for this rulemaking. Commenters included the following: relatives of 
Fire Department of New York (FDNY) members who responded at Ground 
Zero; a FDNY responder; a New York Police Department responder; a 
survivor of the attacks in New York; two labor unions that represent 
WTC responders; the WTC Health Program Survivor Steering Committee; and 
three elected officials. A summary of those comments and the 
Administrator's responses are found in Section VII (Summary of the 
Final Rule and Response to Public Comments) of this document.

III. Background

A. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act) 
to add Title XXXIII \1\ establishing the WTC Health Program within the 
Department of Health and Human Services (HHS). The WTC Health Program 
provides medical monitoring and treatment benefits to eligible 
firefighters and related personnel, law enforcement officers, and 
rescue, recovery, and

[[Page 57506]]

cleanup workers (responders) who responded to the September 11, 2001, 
terrorist attacks in New York City, at the Pentagon, and in 
Shanksville, Pennsylvania, and to eligible persons (survivors) 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.
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    \1\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm 
to 300mm-61. 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 of the WTC Health Program 
(Administrator) in this notice mean the Director of the National 
Institute for Occupational Safety and Health (NIOSH) or his or her 
designee. Section 3312(a)(6) of the PHS Act requires the Administrator 
to conduct rulemaking to propose the addition of a health condition to 
the List of WTC-Related Health Conditions (List) codified in 42 CFR 
88.1.

B. Methods Used by the Administrator To Determine Whether To Add Cancer 
or Types of Cancer to the List of WTC-Related Health Conditions

    In the preamble to a final rule published on September 12, 2012, 
the Administrator established a four-part hierarchical methodology to 
apply in evaluating whether to propose adding certain types of cancer 
to the List of WTC-Related Health Conditions included in 42 CFR 
88.1.\2\ Method 1 is the preferred method for adding types of cancer to 
the List. When the analysis of epidemiologic studies in Method 1 does 
not support a causal association between 9/11 exposures and a type of 
cancer, the Administrator applies the criteria of Method 2.\3\ If no 
causal association between a currently listed condition and the type of 
cancer is identified using Method 2, the Administrator applies the 
criteria of Method 3. If Method 3 does not indicate that a recognized 
9/11 exposure is categorized by the National Toxicology Program (NTP) 
as a known or reasonably anticipated human carcinogen \4\ or the 
International Agency for Research on Cancer (IARC) has not determined 
there is sufficient or limited evidence in humans that a 9/11 exposure 
is causally associated with a type of cancer,\5\ then the criteria of 
Method 4 are applied. Under Method 4, the Administrator determines 
whether the WTC Health Program Scientific/Technical Advisory Committee 
(STAC), if consulted, has provided a reasonable basis for adding the 
type of cancer, aside from Methods 1, 2, or 3 mentioned above. Only 
where the Administrator is satisfied that one of the four methods 
provides a reasonable basis to add the cancer will he propose that a 
type of cancer be added to the List.
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    \2\ 77 FR 56138, 56142.
    \3\ The results of epidemiologic studies are the primary and 
best evidence for making a determination of a causal association 
between an exposure and a health outcome, such as cancer. An 
analysis of the results of any epidemiologic study has three 
possible outcomes: (1) The analysis supports an association between 
exposures and a health outcome (yes); (2) the analysis supports that 
there is no association between exposures and a health outcome (no); 
or (3) the analysis is inconclusive about whether an association 
exists between exposures and a health outcome (inconclusive).
    \4\ National Toxicology Program (NTP), U.S. Department of Health 
and Human Services. Report on Carcinogens (RoC). https://ntp.niehs.nih.gov/?objectid=72016262-BDB7-CEBA-FA60E922B18C2540. 
Accessed August 12, 2013.
    \5\ World Health Organization International Agency for Research 
on Cancer (IARC). https://monographs.iarc.fr/. Accessed August 12, 
2013.
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C. Consideration of Evidence for Adding Prostate Cancer to the List

    On May 2, 2013, the Administrator received Petition 002 from the 
Patrolmen's Benevolent Association, a union representing New York City 
police officers. Petition 002 referenced, and relied upon, a study of 
over 25,000 WTC responders enrolled in the WTC Health Program, authored 
by Solan et al. and published in the scientific journal Environmental 
Health Perspectives.\6\ Petition 002 asserted that the Solan study:
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    \6\ Solan S, Wallenstein S, Shapiro M, Teitelbaum SL, Stevenson 
L, Kochman A, Kaplan J, Dellenbaugh C, Kahn A, Biro FN, Crane M, 
Crowley L, Gabrilove J, Gonsalves L, Harrison D, Herbert R, Luft B, 
Markowitz SB, Moline J, Niu X, Sacks H, Shukla G, Udasin I, Lucchini 
RG, Boffetta P, Landrigan PJ [2013]. Cancer incidence in World Trade 
Center Rescue and Recovery Workers, 2001-2008. Environmental Health 
Perspectives 121(6):699-704.

affirms what was reported in prior published studies, that those 
exposed to the Ground Zero toxins are at higher risk of developing 
cancer than the general population. Notably, the Study found a 
statistically significant incidence rate for prostate cancer, 
including a 17% greater than expected rate of prostate cancer among 
responders. According to the Study, these findings were 
``concordant'' with the findings of the New York City Fire 
Department [FDNY] and the New York City Department of Health and 
Mental Hygiene World Trade Center Health City Registry.\7\
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    \7\ The Petitioner incorrectly states that the Solan study 
reported a 17 percent increase in prostate cancer. Solan et al. 
report a 21 percent increase in prostate cancer when the timeframe 
for diagnosis is unrestricted, and 23 percent when the timeframe for 
diagnosis is restricted.

    The ``prior published studies'' referenced in Petition 002 were 
authored by Zeig-Owens et al., published in The Lancet in September 
2011,\8\ and by Li et al., published in the Journal of the American 
Medical Association (JAMA) in December 2012.\9\ The Zeig-Owens, Li, and 
Solan studies were reviewed and analyzed by the Administrator in the 
notice of proposed rulemaking published July 2, 2013.\10\ The 
Administrator's review focused on the information that the three 
epidemiologic studies, taken as a whole, provided on the question of 
the risk of prostate cancer in association with 9/11 exposures and the 
role of surveillance bias in explaining any observed excess risk. A 
summary of the Administrator's findings regarding the three studies is 
offered below, followed by the Administrator's final determination on 
the addition of prostate cancer to the List.
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    \8\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, 
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K, 
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York 
City Firefighters after the 9/11 Attacks: An Observational Cohort 
Study. The Lancet 378(9794):898-905.
    \9\ Li J, Cone JE, Kahn AR, Brackbill RM, Farfel MR, Greene CM, 
Hadler JL, Stayner LT, Stellman SD [2012]. Association between World 
Trade Center Exposure and Excess Cancer Risk. JAMA 308(23):2479-
2488.
    \10\ 78 FR 39670, 39674-39675.
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IV. Administrator's Determination on Petition 002 Requesting the 
Addition of Prostate Cancer to the List

    In response to Petition 002, the Administrator has reviewed the 
available evidence pertinent to the four-part hierarchical methodology 
described above.\11\ The Administrator's determination to not add 
prostate cancer in the 2012 rulemaking is superseded by his new 
evaluation, discussed in the notice of proposed rulemaking. The 2012 
evaluation relied on the only epidemiologic study available at that 
time, Zeig-Owens, and the STAC's assessment of that study and vote to 
not include prostate cancer in its recommendation. The subsequently 
published Li and Solan studies present new epidemiologic findings from 
larger, more heterogeneous populations and present evidence that 
surveillance bias may not be occurring in the studied populations. 
Review of the two new studies leads the Administrator to determine that 
surveillance bias may not fully explain the increased incidence of 
prostate cancer and, accordingly, the Administrator can no longer 
attribute increased incidence of prostate cancer to surveillance bias 
with adequate certainty.
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    \11\ See pages 39674-39675 of the notice of proposed rulemaking 
(78 FR 39670, July 2, 2013).
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    After comprehensive review of all three epidemiology studies of 9/
11-exposed populations, the Administrator has determined that the 
epidemiologic evidence evaluated under Method 1 is inconclusive. 
Because no relationship

[[Page 57507]]

has been identified between prostate cancer and a condition on the List 
of WTC-Related Health Conditions (Method 2), the review turned to 
evaluating the evidence of carcinogenicity provided by NTP and IARC 
under Method 3. The Administrator has determined that, based on the 
evidence provided in Method 3, prostate cancer will be added to the 
List of WTC-Related Health Conditions on the effective date for this 
final rule.

V. Early Detection of Prostate Cancer

    Early detection of cancer in 9/11-exposed populations--either as 
part of medical monitoring of enrolled WTC responders and survivors or 
part of ongoing research--is an important adjunct to the WTC Health 
Program. The WTC Health Program adheres to the recommendations of the 
U.S. Preventive Services Task Force (USPSTF) with regard to coverage 
for preventive measures, including screening tests, counseling, 
immunizations, and preventive medications. The USPSTF recommends 
against PSA-based screening for prostate cancer.\12\ Therefore, PSA-
based screening for prostate cancer will not be covered by the WTC 
Health Program.
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    \12\ U.S. Preventive Services Task Force. Recommendation: 
Screening for Prostate Cancer (2012). https://www.uspreventiveservicestaskforce.org/prostatecancerscreening.htm. 
Accessed August 12, 2013.
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VI. Effects of Rulemaking on Federal Agencies

    Title II of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Pub. L. 111-347) reactivated the September 11, 2001 Victim 
Compensation Fund (VCF). Administered by the U.S. Department of Justice 
(DOJ), the VCF provides compensation to any individual or 
representative of a deceased individual who was physically injured or 
killed as a result of the September 11, 2001, terrorist attacks or 
during the debris removal. Eligibility criteria for compensation by the 
VCF include a list of presumptively covered health conditions, which 
are physical injuries determined to be WTC-related health conditions by 
the WTC Health Program. Pursuant to DOJ regulations, the VCF Special 
Master is required to update the list of presumptively covered 
conditions when the List of WTC-Related Health Conditions in 42 CFR 
88.1 is updated.

VII. Summary of Final Rule and Response to Public Comments

    The Administrator received 11 public comments on the notice of 
proposed rulemaking. Ten comments support inclusion of prostate cancer 
on the List of WTC-Related Health Conditions.
    One commenter does not support the proposal to add prostate cancer 
to the List. The commenter finds that, because the epidemiologic 
studies published to date are inconclusive with regard to the 
relationship between 9/11 exposures and prostate cancer, adding 
prostate cancer is inappropriate at this time. Further, the commenter 
states that the proposal to add prostate cancer using Method 3 
``threatens the integrity of the decision-making process in the future 
by utilizing unclear science.'' According to the commenter, the 
Administrator did not ``rigorously analyze[ ] the presence and 
concentration of arsenic and cadmium at the attack sites.'' In 
addition, the commenter asserts that the review of evidence by IARC 
does not conclusively support the idea that arsenic and cadmium are 
carcinogenic for prostate cancer. Finally, the commenter believes that 
the addition of prostate cancer will create a strain on the financial 
resources available to both the WTC Health Program and the VCF 
administered by the Department of Justice.
    The Administrator concurs that Method 1 of the Administrator's 
methodology, which evaluates the available epidemiologic evidence, is 
the preferred method for deciding whether to add a cancer to the List 
of WTC-Related Health Conditions. However, epidemiologic studies are 
substantially limited in their ability to provide timely guidance on 
which types of cancer should be added to the List to allow the WTC 
Health Program to provide services to the responders and survivors 
currently suffering from cancers related to 9/11 exposures. Due to the 
traditionally long latency period between exposure and cancer 
diagnosis, many epidemiologic studies of cancer and findings on health 
effects associated with particular exposures are produced years after a 
given exposure event. Waiting for definitive, scientifically-
unassailable epidemiologic results before adding types of cancer to the 
List would be less than ideal given the immediate need for treatment of 
many WTC Health Program members and prospective members. In addition, 
other factors make it difficult to establish positive associations 
using traditional epidemiologic methods within a short time frame. The 
number of potentially exposed individuals is small, so the statistical 
power of any study will be substantially limited. Detecting traditional 
statistically significant increases will be difficult and may only be 
definitively established through a retrospective cohort mortality study 
conducted decades from now.
    While Method 1 is the preferred method, section 3312(a)(6) of the 
PHS Act does not limit the Administrator's methodology to the use of 
traditional epidemiologic methods to add conditions to the List (Method 
1). Upon thorough review of all available information, including peer-
reviewed and unpublished studies, expert opinion, the STAC 
recommendation solicited by the Administrator for the 2012 rulemaking, 
and comments from the public, the Administrator determined in the 
September 2012 final rule that it is reasonable to acknowledge the 
limitations of traditional epidemiologic methods. As the Administrator 
concluded, ``[r]equiring evidence of positive associations from 
epidemiologic studies of 9/11-exposed populations exclusively does not 
serve the best interests of WTC Health Program members.'' \13\ 
Accordingly, the three additional hierarchical methods were established 
to incorporate additional scientific sources of information in the 
evaluation process.
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    \13\ 77 FR 56138, 56156 (September 12, 2012).
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    Method 3 of the Administrator's methodology incorporates 
qualitative exposure information and established relationships between 
exposure agents and types of cancer. The quantitative exposures of 
individuals at the WTC, particularly during the collapse of the towers 
and for several days afterward, will likely never be fully known. 
Reliance on the concentrations found in settled dust samples or 
observations several days or weeks after the attacks does not provide a 
complete understanding of the exposures. While the concentrations of 
arsenic and cadmium in settled dust samples collected from around the 
WTC site were relatively low, the qualitative exposure conditions of 
thick dust clouds, the likely ingestion of dust by individuals at or 
near the site, and the large deposits of dust in homes are likely to 
result in large, short-term exposures.
    Analysis under Method 3 also includes identifying those agents 
categorized (1) by NTP as known or reasonably anticipated to be human 
carcinogens, and (2) by IARC as known, probable, or possible human 
carcinogens and having sufficient or limited evidence for causing 
specific types of cancer in humans. NTP and IARC findings have 
undergone substantial peer review and/or scientific scrutiny in their 
development. These authoritative bodies have categorized arsenic and 
inorganic arsenic

[[Page 57508]]

compounds as well as cadmium and cadmium compounds as known human 
carcinogens, and IARC has determined there is limited evidence that 
arsenic and inorganic arsenic compounds as well as cadmium and cadmium 
compounds cause cancer of the prostate.\14\ Thus, the criteria in 
Method 3, established to add a type of cancer based on relevant 
exposure and an established relationship to a specific type of cancer, 
have been met and prostate cancer is added to the List of WTC-Related 
Health Conditions.
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    \14\ Cogliano VJ, Baan R, Straif K, Grosse Y, Lauby-Secretan B, 
El Ghissassi F, Bouvard B, Benbrahim-Tallaa L, Guha N, Freeman C, 
Galichet L, Wild CP [2011]. Preventable Exposures Associated with 
Human Cancers. Journal of the National Cancer Institute 103:1827-
1839.
     IARC (International Agency for Research on Cancer) [2012]. IARC 
Monographs on the Evaluation of Carcinogenic Risks to Humans: Vol. 
100--A Review of Human Carcinogens. Part C: Arsenic, Metals, Fibres, 
and Dusts. IARC, Lyon, France. https://monographs.iarc.fr/ENG/Monographs/vol100C/index.php. Accessed August 7, 2013.
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    The Administrator understands the concerns about the lack of 
certainty in these methods and potential adverse impact on the VCF. 
However, the Administrator notes that individuals who are not currently 
enrolled in the WTC Health Program must first be determined to be 
eligible and qualified to enroll. The Administrator also notes that 
listing a cancer as a WTC-related health condition does not necessarily 
mean that a cancer in an individual WTC responder or survivor diagnosed 
by a Program physician will be determined to be WTC-related. Each WTC 
responder and survivor enrolled in the Program will go through a 
physician's determination and Program certification process to assess 
whether the individual's cancer meets the statutory definition of a 
WTC-related health condition.\15\ The use of individual medical history 
and exposure assessment as part of the determination and certification 
process will reduce the uncertainties inherent in the methods used to 
determine which cancers to add to the List. Guidelines for 
determination and certification of a WTC-related health condition have 
been jointly developed by the WTC Health Program and the Clinical 
Centers of Excellence (CCE) for conditions on the List. With this input 
from the CCEs, the WTC Health Program will develop additional 
instructions to assess, for purposes of certification, whether an 
individual's 9/11 exposure may have contributed to, aggravated, or 
caused their prostate cancer. Similarly, the VCF employs rigorous 
standards used to determine individual compensation awards. The 
Administrator is not in a position to comment on the budget impact that 
this regulation will have on the VCF as matters concerning VCF 
administration are outside the scope of this rulemaking.
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    \15\ ``An illness or health condition for which exposure to 
airborne toxins, any other hazard, or any other adverse condition 
resulting from the September 11, 2001, terrorist attacks, based on 
an examination by a medical professional with experience in treating 
or diagnosing the health conditions included in the applicable list 
of WTC-related health conditions, is substantially likely to be a 
significant factor in aggravating, contributing to, or causing the 
condition.'' PHS Act, sec. 3312(a)(1)(A)(i).
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    For the reasons discussed above and in the notice of proposed 
rulemaking published July 2, 2013, the Administrator amends 42 CFR 
88.1, paragraph (4), Table 1, to add malignant neoplasm of the prostate 
(prostate cancer) and to add the corresponding medical diagnostic 
codes.\16\
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    \16\ ICD-9 code 185 and ICD-10 code C61. See, respectively, WHO 
(World Health Organization) [1978]. International Classification of 
Diseases, Ninth Edition; WHO [1997]. International Classification of 
Diseases, Tenth Edition.
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VIII. Regulatory Assessment Requirements

A. Executive Order 12866 and Executive Order 13563

    Executive Orders (E.O.) 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). E.O. 
13563 emphasizes the importance of quantifying both costs and benefits, 
of reducing costs, of harmonizing rules, and of promoting flexibility.
    This final rule has been determined not to be a ``significant 
regulatory action'' under sec. 3(f) of E.O. 12866, and therefore has 
not been reviewed by the Office of Management and Budget (OMB). The 
addition of prostate cancer by this rulemaking is estimated to cost the 
WTC Health Program between $3,462,675 \17\ and $6,995,817 \18\ per 
annum. All of the costs to the WTC Health Program will be transfers 
after the implementation of provisions of the Patient Protection and 
Affordable Care Act (Pub. L. 111-148) on January 1, 2014. The rule 
would not interfere with State, local, and Tribal governments in the 
exercise of their governmental functions.
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    \17\ Based on a population of 60,000 at the U.S. cancer rate and 
discounted at 7 percent.
    \18\ Based on a population of 110,000 at 21 percent above the 
U.S. cancer rate and discounted at 3 percent.
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Cost Estimates
    The WTC Health Program has, to date, enrolled approximately 58,500 
WTC responders and approximately 6,500 survivors, or approximately 
65,000 individuals in total. Of that total population, approximately 
60,000 individuals were participants in previous WTC medical programs 
and were `grandfathered' into the WTC Health Program established by 
Title XXXIII.\19\ In addition to those grandfathered WTC responders and 
survivors already enrolled, the PHS Act sets a numerical limitation on 
the number of eligible members who can enroll in the WTC Health Program 
beginning July 1, 2011 at 25,000 new WTC responders and 25,000 new WTC 
survivors (i.e., the statute restricts new enrollment).\20\ Since July 
1, 2011, a total of approximately 3,000 new WTC responders and new WTC 
survivors (over 1,700 responders and 1,200 survivors) have enrolled in 
the WTC Health Program, resulting in only a minor impact on the 
statutory enrollment limits for new members. For the purpose of 
calculating a baseline estimate of cancer prevalence only, the 
Administrator assumed that this gradual rate of enrollment would 
continue, and that the currently enrolled population numbers would 
remain around 58,500 WTC responders and 6,500 WTC survivors. The 
estimate is further based on the average U.S. cancer prevalence rate 
and 7 percent discount rate.
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    \19\ These grandfathered members were enrolled without having to 
complete a new member application when the WTC Health Program 
started on July 1, 2011 and are referred to in the WTC Health 
Program regulations in 42 CFR Part 88 as ``currently identified 
responders'' and ``currently identified survivors.''
    \20\ PHS Act, secs. 3311(a)(4)(A) and 3321(a)(3)(A).
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    As it is not possible to identify an upper bound estimate, HHS has 
modeled another possible point on the continuum. For the purpose of 
calculating the impact of an increased rate of cancer on the WTC Health 
Program, this analysis assumes that the entire statutory cap for new 
WTC responders (25,000) and WTC survivors (25,000) will be filled. 
Accordingly, this estimate is based on a population of 80,000 
responders (55,000 grandfathered + 25,000 new) and 30,000 survivors 
(5,000 grandfathered + 25,000 new). The upper cost estimate also 
assumes an overall increase in population cancer rates (for malignant 
neoplasm of the prostate [prostate cancer] of 21 percent due to 9/11

[[Page 57509]]

exposure),\21\ and costs were discounted at 3 percent. The choice of a 
21 percent increase in the risk of cancer of the rate found in the un-
exposed population is based on findings presented in the first 
published epidemiologic study of September 11, 2001 exposed 
populations.\22\ Given the challenges associated with interpreting the 
Zeig-Owens findings,\23\ we simply characterize 21 percent as a 
possible outcome rather than asserting the probability that 21 percent 
is a ``likely'' outcome.
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    \21\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, 
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K, 
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York 
City Firefighters after the 9/11 Attacks: An Observational Cohort 
Study. The Lancet 378(9794):898-905.
    \22\ Id.
    \23\ As Zeig-Owens et al. point out, the time interval since 9/
11 is short for cancer outcomes, the recorded excess of cancers is 
not limited to specific sites, and the biological plausibility of 
chronic inflammation as a possible mediator between WTC-exposure and 
cancer means that the outcomes remain speculative.
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    The Administrator acknowledges that some prostate cancer cases are 
not likely to have been caused by 9/11 exposures. The certification of 
individual cancer diagnoses will be conducted on a case-by-case basis. 
However, for the purpose of this analysis, the Administrator has 
estimated that all diagnosed cancers added to the List will be 
certified for treatment by the WTC Health Program. Finally, because 
there are no existing data on cancer rates related to 9/11 exposures at 
either the Pentagon or in Shanksville, Pennsylvania, the Administrator 
has used only data from studies of individuals who were responders or 
survivors in the New York City disaster area.
Costs of Cancer Treatment
    The Administrator estimated the treatment costs associated with 
covering prostate cancer in this rulemaking using the methods described 
below. The WTC Health Program obtained data for the cost of providing 
medical treatment for prostate cancer.\24\ The costs of treatment are 
described in Table A. The costs of treatment are divided into three 
phases: The costs for the first year following diagnosis, the costs of 
intervening years or continuing treatment after the first year, and the 
costs of treatment for the last year of life. The first year costs of 
cancer treatment are higher due to the initial need for aggressive 
medical (e.g., radiation, chemotherapy) and surgical care. The costs 
during last year of life are often dominated by increased 
hospitalization costs.\25\ Therefore, we used three different treatment 
phase costs to estimate the costs of treatment to be able to best 
estimate costs in conjunction with expected incidence and long-term 
survival rates for prostate cancer.
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    \24\ Yabroff KR, Lamont EB, Mariotto A, Warren JL, Topor M, 
Meekins A, Brown ML [2008]. Cost of Care for Elderly Cancer Patients 
in the United States. Journal of the National Cancer Institute 
100(9):630-41.
    \25\ Id.

     Table A--Average Costs of Treatment for Prostate Cancer (2011$)
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                                      Continuing       Last year of life
       Initial  (12 month)             (annual)            (12 mos.)
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$13,696.........................              $2,754             $43,481
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    These cost figures were based on a study of elderly cancer patients 
from the Surveillance, Epidemiology, and End Results (SEER) program 
maintained by the National Cancer Institute using Medicare files.\26\ 
The average costs of treatment described above are given in 2011 prices 
adjusted using the Medical Consumer Price Index for all urban 
consumers.\27\
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    \26\ Surveillance, Epidemiology, and End Results (SEER) Program 
(www.seer.cancer.gov) Research Data (1973-2006), National Cancer 
Institute, DCCPS, Surveillance Research Program, Surveillance 
Systems Branch, released April 2009, based on the November 2008 
submission.
    \27\ Bureau of Labor Statistics. Consumer Price Index. Available 
at https://research.stlouisfed.org/fred2/series/CPIMEDSL/downloaddata?cid=32419. Accessed August 12, 2013.
---------------------------------------------------------------------------

Incident Cases of Cancer
    The Administrator estimated the expected number of cases of cancer 
that would be observed in a cohort of responders and survivors followed 
for cancer incidence after September 11, 2001 using U.S. population 
cancer rates for prostate cancer. Demographic characteristics of the 
cohort were assigned since the actual data are not available for 
individuals in the responder and survivor populations who have not yet 
enrolled in the WTC Health Program. Gender and age (at the time of 
exposure) distributions for responders and survivors were assumed to be 
the same as current members in the WTC Health Program. According to WTC 
Health Program data, males comprise 88 percent of the current responder 
members and 50 percent of survivor members. Because prostate cancer 
occurs only in males, all calculations only take into account male WTC 
Health Program members. The age distribution for current members by 
gender and responder/survivor status is presented in Table B.

      Table B--Percentiles of Current Age (on April 11, 2012) for Current Members in the WTC Health Program by Gender and Responder/Survivor Status
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Age percentile (years)
                        Group                         --------------------------------------------------------------------------------------------------
                                                          Min         1          10         30         50         70         90         99        Max
--------------------------------------------------------------------------------------------------------------------------------------------------------
Male responders......................................         28         32         39         44         49         54         62         74         92
Female responders....................................         28         30         38         44         49         54         62         76         92
Male survivors.......................................         12         23         35         46         52         58         67         81         99
Female survivors.....................................         12         21         38         49         54         60         68         84         95
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The Administrator assumed race and ethnic origin distributions for 
responders and survivors according to distributions in the WTC Health 
Registry cohort: \28\ 57 percent non-

[[Page 57510]]

Hispanic white, 15 percent non-Hispanic black, 21 percent Hispanic, and 
8 percent other race/ethnicity for responders and 50 percent non-
Hispanic white, 17 percent non-Hispanic black, 15 percent Hispanic, and 
18 percent other race/ethnicity for survivors. Follow-up for cancer 
morbidity for each person began on January 1, 2002 or age 15 years, 
whichever was later. Age 15 was considered because the cancer incidence 
rate file did not include rates for persons less than 15 years of age. 
Follow-up ended on December 31, 2016 or the estimated last year of 
life, whichever was earlier. The estimated last year of life was used 
since not all persons would be expected to remain alive at the end of 
2016. The estimated last year of life was based on U.S. gender, race, 
age, and year-specific death rates from CDC Wonder (since rates are 
currently available through 2008, the rate from 2008 was applied to 
2009 and later).\29\ A life-table analysis program, LTAS.NET, was used 
to estimate the expected number of incident cancers for prostate 
cancer.\30\ The Administrator calculated cancer incidence rates using 
data through 2006 from the Surveillance Epidemiology and End Results 
(SEER) Program and estimated rates for 2007-2016.\31\ The Program 
applied the resulting gender, race, age, and year-specific cancer 
incidence rates to the estimated person-years at risk to estimate the 
expected number of cancer cases for prostate cancer starting from year 
2002, the first full year following the September 11, 2001, terrorist 
attacks, to 2016, the last year for which this Program is currently 
funded.
---------------------------------------------------------------------------

    \28\ Jordan HT, Brackbill RM, Cone JE, Debchoudhury I, Farfel 
MR, Greene CM, Hadler JL, Kennedy J, Li J, Liff J, Stayner L, 
Stellman SD [2011]. Mortality Among Survivors of the Sept 11, 2001, 
Word Trade Center Disaster: Results from the World Trade Center 
Health Registry Cohort. The Lancet 378:879-887. Note: percentages 
may not sum to 100 percent due to rounding.
    \29\ Centers for Disease Control and Prevention, National Center 
for Health Statistics. Compressed Mortality File 1999-2008. CDC 
WONDER Online Database, compiled from Compressed Mortality File 
1999-2008 Series 20 No. 2N, 2011. https://wonder.cdc.gov/cmf-icd10.html. Accessed August 12, 2013.
    \30\ Schubauer-Berigan MK, Hein MJ, Raudabaugh WM, Ruder AM, 
Silver SR, Spaeth S, Steenland K, Petersen MR, and Waters KM [2011]. 
Update of the NIOSH Life Table Analysis System: A Person-Years 
Analysis program for the Windows Computing Environment. American 
Journal of Industrial Medicine 54:915-924.
    \31\ National Cancer Institute, Surveillance Epidemiology and 
End Results (SEER). https://seer.cancer.gov/. Accessed August 12, 
2013.
---------------------------------------------------------------------------

Prevalence of Cancer
    To determine the potential number of persons in the responder and 
survivor populations with cancer, the Administrator used the number of 
incident cases described above for each year starting with 2002 and 
estimated the prevalence of cancer using survival rate statistics for 
each incident cancer group through 2016.\32\ Using the incident cases 
and survival rate statistics, HHS has estimated the prevalence (number 
of persons living with cancer) of cases during the 15 year period 
(2002-2016) since September 11, 2001. The resulting table provides for 
each year from 2002 through 2016, the number of new cases occurring in 
that year (incidence), the number of individuals who died from their 
cancer in that year, and the number of persons surviving up to 15 years 
beyond their first diagnosis (prevalence).\33\ For example, in 2002 
there are 34.22 projected new cases of prostate cancer, which would be 
listed as incident cases for that year. The survival rate for prostate 
cancer in the first year of diagnosis is 99.44 percent.\34\ Therefore 
the number of deceased persons in 2002 would be 34.22 x (1-0.9944) = 
0.19. For the prostate cancer prevalence table, in year 2003, the 
number of incident cases would be 38.55 cases. In addition to 38.55 
newly diagnosed cases in 2003, there would be the one-year survivors 
from 2002 which would be 34.22-0.19 = 34.03 cases. This computation 
process can be repeated for each year through year 2016. A portion of 
the prostate cancer prevalence tables are provided in Table C. 
Prevalence is summarized in Tables E and G. This analysis considers 
cancers diagnosed in 2002 through 2016.
---------------------------------------------------------------------------

    \32\ Id.
    \33\ The 15-year survival limit is imposed based on the analytic 
time horizon established between the triggering events of September 
11, 2001 and the authorization of the WTC Health Program through 
2016.
    \34\ National Cancer Institute, Surveillance Epidemiology and 
End Results (SEER). https://seer.cancer.gov/. Accessed August 12, 
2013.

                                                     Table C-- Prevalence Table for Prostate Cancer
                                                              [Based on 80,000 responders]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                          Year                                       Years since 9/11 exposure                  Years covered by WTC Health Program
--------------------------------------------------------------------------------------------------------------------------------------------------------
                        New/Surv.                              2002            2003            2013            2014            2015            2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.......................................................           34.22           38.55          112.54          123.98          134.46          146.33
2.......................................................  ..............           34.03          100.76          111.92          123.29          133.72
3.......................................................  ..............  ..............           88.67           99.55          110.57          121.81
4.......................................................  ..............  ..............           79.02           87.58           98.33          109.22
5.......................................................  ..............  ..............           71.15           78.61           87.13           97.82
6.......................................................  ..............  ..............           63.27           70.41           77.80           86.23
7.......................................................  ..............  ..............           55.71           62.74           69.83           77.15
8.......................................................  ..............  ..............           48.22           55.06           62.01           69.01
9.......................................................  ..............  ..............           42.10           47.91           54.71           61.61
10......................................................  ..............  ..............           39.77           41.51           47.24           53.95
11......................................................  ..............  ..............           35.02           39.38           41.11           46.77
12......................................................  ..............  ..............           30.91           34.83           39.17           40.88
13......................................................  ..............  ..............  ..............           30.43           34.29           38.56
14......................................................  ..............  ..............  ..............  ..............           30.26           34.10
15......................................................  ..............  ..............  ..............  ..............  ..............           30.06
Live cases from previous years..........................            0.00           34.03          654.61          759.95          875.74         1000.89
Prevalence..............................................           34.22           72.58          767.15          883.93         1010.20         1147.22
Last year of life.......................................            0.19            0.62            7.20            8.19            9.31           10.65
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 57511]]

Cost Computation
    To compute the costs for prostate cancer, the Administrator assumes 
that all of the individuals who are diagnosed with prostate cancer will 
be certified by the WTC Health Program for treatment and monitoring 
services. The treatment costs for the first year of treatment (Table A, 
year adjusted) were applied to the predicted newly incident (Year 1) 
cases for each year. Likewise, the costs of treatment for the last year 
of life were applied in each year to the number of people predicted to 
die from their cancer in that year. The costs of continuing treatment 
from Table A were applied to the number of prevalent cases who had 
survived their cancers beyond their year of diagnosis, for each year of 
survival (Year 2-15).
    Using this procedure, a cost table was constructed for each year 
covered by the WTC Health Program and the results are presented in 
Table D. The row for Year 1 in each table is the cost of incident cases 
for that year. Rows for years 2-15 show the cost from continuing care 
for persons surviving n-years beyond the year of diagnosis. Finally, 
the cost of last year of life treatment is computed by multiplying the 
cost for last year of life from Table A by the number of persons dying 
in that year from prostate cancer from Table C.

                         Table D--Cost per 80,000 Responders for Prostate Cancer, 2011$
----------------------------------------------------------------------------------------------------------------
                                                                      Years covered by the WTC Health Program
----------------------------------------------------------------------------------------------------------------
                              Year                                     2014            2015            2016
----------------------------------------------------------------------------------------------------------------
1...............................................................      $1,688,586      $1,831,435      $1,993,026
2...............................................................         308,251         339,563         368,289
3...............................................................         274,159         304,530         335,464
4...............................................................         241,216         270,809         300,809
5...............................................................         216,509         239,972         269,413
6...............................................................         193,930         214,266         237,486
7...............................................................         172,786         192,305         212,470
8...............................................................         151,653         170,779         190,071
9...............................................................         131,942         150,680         169,685
10..............................................................         114,331         130,098         148,574
11..............................................................         108,466         113,209         128,822
12..............................................................          95,925         107,868         112,586
13..............................................................          83,816          94,438         106,196
14..............................................................  ..............          83,345          93,906
15..............................................................  ..............  ..............          82,779
Prevalent care..................................................       3,781,570       4,243,298       4,666,796
Last year of life care..........................................         356,227         404,804         463,183
                                                                 -----------------------------------------------
    Total.......................................................       4,137,798       4,648,102       5,129,979
----------------------------------------------------------------------------------------------------------------

    The sum of the annual costs in the table for the years 2014 through 
2016 represents the estimated treatment costs to the WTC Health Program 
for coverage of prostate cancer for 80,000 responders. The same process 
described above was applied to the survivor cohort. Based on the 
incidence rate expected from the survivor cohort, prevalence tables 
were constructed. The estimated treatment costs for responders and 
survivors were re-computed under the following two assumptions: (1) The 
rate of cancer in the WTC Health Program is equal to the rate of cancer 
observed in the general population; and (2) the rate of cancer exceeds 
the general population rate by 21 percent due to their WTC 
exposures.\35\
---------------------------------------------------------------------------

    \35\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, 
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K, 
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York 
City Firefighters after the 9/11 Attacks: An Observational Cohort 
Study. The Lancet 378(9794):898-905. Limitations of the Zeig-Owens 
study include: Limited information on specific exposures experienced 
by firefighters; short time for follow-up of cancer outcomes; 
speculation about the biological plausibility of chronic 
inflammation as a possible mediator between WTC-exposure and cancer 
outcomes; and potential unmeasured confounders.
---------------------------------------------------------------------------

    A summary of the estimated prevalence at the U.S. population 
average for the assumed population of 58,500 responders and 6,500 
survivors is provided in Table E. A summary of the estimated treatment 
costs to the WTC Health Program is provided in Table F. A summary of 
the estimated prevalence using cancer rates 21 percent over the U.S. 
population average for the increased rate of 80,000 responders and 
30,000 survivors is given in Table G. A summary of the estimated 
treatment costs to the WTC Health Program is provided in Table H.

    Table E--Estimated Prevalence of Prostate Cancer by Year Based on 58,500 and 6,500 Responder and Survivor
                  Population, Respectively and Assuming Cancer Rates at U.S. Population Average
----------------------------------------------------------------------------------------------------------------
                                                                        Prevalence  (incident + live cases)
                           Population                            -----------------------------------------------
                                                                       2014            2015            2016
----------------------------------------------------------------------------------------------------------------
Based on 58,500 responders......................................          646.37          738.71          838.90
Based on 6,500 survivors........................................           65.95           73.93           82.41
----------------------------------------------------------------------------------------------------------------


[[Page 57512]]


 Table F--Estimated Treatment Costs of Prostate Cancer by Year Based on 58,500 and 6,500 Responder and Survivor
              Population, Respectively and Assuming Cancer Rates at U.S. Population Average (2011$)
----------------------------------------------------------------------------------------------------------------
                   Population                          2014            2015            2016          2014-2016
----------------------------------------------------------------------------------------------------------------
Based on 58,500 responders......................      $3,025,765      $3,398,924      $3,751,298     $10,175,987
Based on 6,500 survivors........................         296,297         326,642         352,170         975,109
----------------------------------------------------------------------------------------------------------------


   Table G--Estimated Prevalence of Prostate Cancer by Year Based on 80,000 and 30,000 Responder and Survivor
  Population, Respectively and Assuming Incidence of Cancer is 21% Higher Than the U.S. Population Due to 9/11
                                                    Exposure
----------------------------------------------------------------------------------------------------------------
                                                                        Prevalence  (incident + live cases)
                           Population                            -----------------------------------------------
                                                                       2014            2015            2016
----------------------------------------------------------------------------------------------------------------
Based on 80,000 responders......................................         1069.55         1222.34         1388.13
Based on 30,000 survivors.......................................          368.31          412.86          460.19
----------------------------------------------------------------------------------------------------------------


 Table H--Estimated Treatment Costs of Prostate Cancer by Year Based on 80,000 and 30,000 Responder and Survivor
  Population, Respectively and Assuming Incidence of Cancer is 21% Higher Than the U.S. Population Due to 9/11
                                                Exposure (2011$)
----------------------------------------------------------------------------------------------------------------
                   Population                          2014            2015            2016          2014-2016
----------------------------------------------------------------------------------------------------------------
Based on 80,000 responders......................      $5,089,491      $5,717,165      $6,309,875     $17,116,531
Based on 30,000 survivors.......................       1,378,925       1,520,138       1,638,947       4,538,010
----------------------------------------------------------------------------------------------------------------

Summary of Costs
    Because HHS lacks data to account for recoupment by workers' 
compensation insurance or reduction by either health insurance or 
Medicare/Medicaid payments, the estimates offered here are reflective 
of estimated WTC Health Program costs only. This analysis offers an 
assumption about the number of individuals who might enroll in the WTC 
Health Program and estimates the impact of both a low rate of cancer 
(U.S. population average rate) and an increased rate (21 percent 
greater than the U.S. population average) on the number of cases and 
the resulting estimated treatment costs to the WTC Health Program. This 
analysis does not include administrative costs associated with 
certifying additional diagnoses of cancers that are WTC-related health 
conditions that might result from this action. Those costs were 
addressed in the interim final rule that established regulations for 
the WTC Health Program (76 FR 38914, July 1, 2011).
    After the implementation of provisions of the Affordable Care Act 
on January 1, 2014, all of the members and future members can be 
assumed to have or have access to medical insurance coverage other than 
through the WTC Health Program. Therefore, all treatment and screening 
costs to be paid by the WTC Health Program from 2014 through 2016 are 
considered transfers. Table I describes the allocation of WTC Health 
Program transfer payments based on 58,500 responders and 6,500 
survivors and, alternatively, 80,000 responders and 30,000 survivors.

 Table I--Breakdown of Estimated Annual WTC Health Program Transfers for
  Prostate Cancer Based on 80,000 and 58,500 Responders and 30,000 and
                    6,500 Survivors, 2014-2016, 2011$
------------------------------------------------------------------------
                                   Annualized transfers for  2014-2016,
                                                   2011$
                                 ---------------------------------------
                                    Discounted at 7     Discounted at 3
                                        percent             percent
------------------------------------------------------------------------
                                                Cancer Rate
                                 ---------------------------------------
                                     U.S. average        U.S. average
                                                                   + 21%
                                 ---------------------------------------
58,500 Responders...............          $3,159,619  ..................
6,500 Survivors.................            $303,056  ..................
                                 ---------------------------------------
    65,000 Total................          $3,462,675  ..................
80,000 Responders...............  ..................          $5,529,266
30,000 Survivors................  ..................          $1,466,551
                                 ---------------------------------------
    110,000 Total...............  ..................          $6,995,817
------------------------------------------------------------------------


[[Page 57513]]

Examination of Benefits (Health Impact)
    This section describes qualitatively the potential benefits of the 
final rule in terms of the expected improvements in the health and 
health-related quality of life of potential prostate cancer patients 
treated through the WTC Health Program, compared to no Program. The 
assessment of the health benefits for prostate cancer patients uses the 
number of expected cancer cases that was estimated in the cost analysis 
section.
    The Administrator does not have information on the health of the 
population that may 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 
health care services for prostate cancers potentially caused by 9/11 
exposures and suffered by any population of responders and survivors, 
including responders and survivors currently enrolled in the WTC Health 
Program and responders and survivors not enrolled in the Program. For 
the purposes of this analysis, the Administrator assumes that broad 
trends on demographics and access to health insurance reported by the 
U.S. Census Bureau and health care services for cancer similar to those 
reported by Ward et al.\36\ would apply to the population of general 
responders (those individuals who are not members of the FDNY and who 
meet the eligibility criteria in 42 CFR Part 88 for WTC responders) and 
survivors both within and outside the Program. For the purposes of this 
analysis, the Administrator assumes that access to health insurance and 
health care services for FDNY responders within and outside the Program 
would be equivalent because this population is overwhelmingly covered 
by employer-based health insurance.
---------------------------------------------------------------------------

    \36\ Ward E, Halpern M, Schrag N, Cokkinides V, DeSantis C, 
Bandi P, Siegel R, Stewart A, Jemal A [2008]. Association of 
Insurance with Cancer Care Utilization and Outcomes. CA Cancer 
Journal for Clinicians 58:9-31.
---------------------------------------------------------------------------

    Although the Administrator cannot quantify the benefits associated 
with the WTC Health Program, members with prostate cancer would have 
improved access to care and thereby the Program should produce better 
treatment outcomes than in its absence. Under other insurance plans, 
patients would have deductibles and copays, which impact access to care 
and particularly its timeliness.\37\ WTC Health Program members would 
have first-dollar coverage and hence are likely to seek care sooner 
when indicated, resulting in improved treatment outcomes.
---------------------------------------------------------------------------

    \37\ 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. Annals of Internal 
Medicine 148(9):647-655.
---------------------------------------------------------------------------

Limitations
    The analysis presented here was limited by the dearth of verifiable 
data on the prostate cancer status of responders and survivors who have 
yet to apply for enrollment in the WTC Health Program. Because of the 
limited data, the Administrator was not able to estimate benefits in 
terms of averted healthcare costs. Nor was the Administrator able to 
estimate administrative costs, or indirect costs, such as averted 
absenteeism, short and long-term disability, and productivity losses 
averted due to premature mortality.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 
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. The 
Administrator believes that this rule has ``no significant economic 
impact upon a substantial number of small entities'' within the meaning 
of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).

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 OMB approval of, 
any regulation that requires 10 or more people to report information to 
the agency or to keep certain records. Data collection and 
recordkeeping requirements for the WTC Health Program are approved by 
OMB under ``World Trade Center Health Program Enrollment, Appeals & 
Reimbursement'' (OMB Control No. 0920-0891, exp. December 31, 2014). 
The Administrator has determined that no changes are needed to the 
information collection request already approved by OMB.

D. Small Business Regulatory Enforcement Fairness Act

    As required by Congress under the Small Business Regulatory 
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), HHS will 
report the promulgation of this rule to Congress prior to its effective 
date.

E. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 
et seq.) directs agencies to assess the effects of Federal regulatory 
actions on State, local, and Tribal governments, and the private sector 
``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' For purposes of the 
Unfunded Mandates Reform Act, this final rule does not include any 
Federal mandate that may result in increased annual expenditures in 
excess of $100 million in 1995 dollars by State, local or Tribal 
governments in the aggregate, or by the private sector. However, the 
rule may result in an increase in the contribution made by New York 
City for treatment and monitoring, as required by Title XXXIII, Sec. 
3331(d)(2). For 2013, the inflation adjusted threshold is $150 million.

F. Executive Order 12988 (Civil Justice)

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

G. Executive Order 13132 (Federalism)

    The Administrator has reviewed this 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.''

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

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

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

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

[[Page 57514]]

J. Plain Writing Act of 2010

    Under Public Law 111-274 (October 13, 2010), 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. The Administrator has attempted to 
use plain language in promulgating the final rule consistent with the 
Federal Plain Writing Act guidelines.

List of Subjects in 42 CFR Part 88

    Aerodigestive disorders, Appeal procedures, Cancer, Health care, 
Mental health conditions, Musculoskeletal disorders, Respiratory and 
pulmonary diseases.

Final Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services amends 42 CFR Part 88 as follows:

PART 88--WORLD TRADE CENTER HEALTH PROGRAM

0
1. The authority citation for Part 88 continues to read as follows:

    Authority:  42 U.S.C. 300mm-300mm-61, Pub. L. 111-347, 124 Stat. 
3623.


Sec.  88.1  [Amended]

0
2. In Sec.  88.1, under paragraph (4) of the definition ``List of WTC-
Related Health Conditions,'' revise Table 1 to read as follows:


Sec.  88.1  Definitions.

* * * * *
    List of WTC-related health conditions * * *
    (4)* * *
BILLING CODE 4150-28-P

[[Page 57515]]

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[[Page 57523]]


[GRAPHIC] [TIFF OMITTED] TR19SE13.008

* * * * *

    Dated: September 10, 2013.
John 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. 2013-22800 Filed 9-18-13; 8:45 am]
BILLING CODE 4150-28-C