Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Rules and Regulations 57505 

1Title 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. 

STATE OF WASHINGTON NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES—Continued 

Name of SIP provision Applicable geographic or 

nonattainment area 

State submittal 

date EPA approval date Comments 

Approval of Motor Vehicle 

Emission Budgets and Determination of Attainment for 

the 2006 24-Hour Fine Particulate Standard.

Tacoma, Pierce County ......... 11/28/12 9/19/13, [Insert page number 

where the document begins].

* * * * * * * 

* * * * * 

[FR Doc. 2013–22738 Filed 9–18–13; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 WTCRelated 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 WTCRelated 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 


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57506 Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Rules and Regulations 

2 77 FR 56138, 56142. 

3The 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). 

4National Toxicology Program (NTP), U.S. 

Department of Health and Human Services. Report 

on Carcinogens (RoC). http://ntp.niehs.nih.gov/

?objectid=72016262-BDB7-CEBAFA60E922B18C2540. Accessed August 12, 2013. 

5World Health Organization International Agency 

for Research on Cancer (IARC). http://

monographs.iarc.fr/. Accessed August 12, 2013. 

6Solan 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. 

7The 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. 

8Zeig-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. 

9Li 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. 

11See pages 39674–39675 of the notice of 

proposed rulemaking (78 FR 39670, July 2, 2013). 

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. 

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 WTCRelated 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. 

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: 

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

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. 

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 fourpart 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. 

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 


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12U.S. Preventive Services Task Force. 

Recommendation: Screening for Prostate Cancer 

(2012). http://www.uspreventiveservicestask

force.org/prostatecancerscreening.htm. Accessed 

August 12, 2013. 13 77 FR 56138, 56156 (September 12, 2012). 

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. 

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 WTCRelated 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, scientificallyunassailable 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. 

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 


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57508 Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Rules and Regulations 

14Cogliano VJ, Baan R, Straif K, Grosse Y, LaubySecretan B, El Ghissassi F, Bouvard B, BenbrahimTallaa 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. http://monographs.iarc.fr/ENG/ 

Monographs/vol100C/index.php. Accessed August 

7, 2013. 

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 WTCrelated 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). 

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. 

17Based on a population of 60,000 at the U.S. 

cancer rate and discounted at 7 percent. 

18Based on a population of 110,000 at 21 percent 

above the U.S. cancer rate and discounted at 3 

percent. 

19These 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.’’ 

20PHS Act, secs. 3311(a)(4)(A) and 3321(a)(3)(A). 

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. 

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. 

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

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. 

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. 

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 


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Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Rules and Regulations 57509 

21Zeig-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. 

23As 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 WTCexposure and cancer means that the outcomes 

remain speculative. 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. 

26Surveillance, 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. 

27Bureau of Labor Statistics. Consumer Price 

Index. Available at https://research.stlouisfed.org/ 

fred2/series/CPIMEDSL/downloaddata?cid=32419. 

Accessed August 12, 2013. 

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, 

Continued 

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 ZeigOwens findings,23 we simply 

characterize 21 percent as a possible 

outcome rather than asserting the 

probability that 21 percent is a ‘‘likely’’ 

outcome. 

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 caseby-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. 

TABLE A—AVERAGE COSTS OF TREATMENT FOR PROSTATE CANCER (2011$) 

Initial 

(12 month) 

Continuing 

(annual) 

Last year of life 

(12 mos.) 

$13,696 .................................................................................................................................................... $2,754 $43,481 

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

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

Group 

Age percentile (years) 

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 nonVerDate Mar<15>2010 16:29 Sep 18, 2013 Jkt 229001 PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 E:\FR\FM\19SER1.SGM 19SER1

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57510 Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Rules and Regulations 

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. 29Centers 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. http:// 

wonder.cdc.gov/cmf-icd10.html. Accessed August 

12, 2013. 

30Schubauer-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. 

31National Cancer Institute, Surveillance 

Epidemiology and End Results (SEER). http:// 

seer.cancer.gov/. Accessed August 12, 2013. 

32 Id. 

33The 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. 

34National Cancer Institute, Surveillance 

Epidemiology and End Results (SEER). http:// 

seer.cancer.gov/. Accessed August 12, 2013. 

Hispanic white, 15 percent nonHispanic 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 personyears 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. 

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 × (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. 

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 


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Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Rules and Regulations 57511 

35Zeig-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. 

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

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

Population 

Prevalence 

(incident + live cases) 

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 


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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

Population 

Prevalence 

(incident + live cases) 

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 

percent 

Discounted at 3 

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 


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Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Rules and Regulations 57513 

36Ward 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. 

37Wharam 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. 

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 employerbased health insurance. 

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. 

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-forprofit 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. 


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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 

■ 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. 

§ 88.1 [Amended] 

■ 2. In § 88.1, under paragraph (4) of the 

definition ‘‘List of WTC-Related Health 

Conditions,’’ revise Table 1 to read as 

follows: 

§ 88.1 Definitions. 

* * * * * 

List of WTC-related health conditions 

* * * 

(4)* * * 

BILLING CODE 4150–28–P 


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Region 

Head & Neck 

Table 1 -- List of types of cancer included in the List of WTCRelated Health Conditions 

T)£(!e of Cancer ICO-10! ICO-92 

Malignant neoplasm of lip COO 140 

• External upper lip • COO.O • 140.0 

• External lower lip COO.1 • 140.1 • 

• External lip, unspecified COO.2 • 140.9 • 

• Upper lip, inner aspect • COO.3 • 140.3 

• Lower lip, inner aspect • COO.4 • 140.4 

• Lip, unspecified, inner aspect • COO.5 • 140.5 

• Commissure of lip • COO.6 • 140.6 

• Overlapping lesion of lip • COO.B • 140.8 

• Lip, unspecified • COO.9 • 140.9 

Malignant neoplasm of base of tongue COl 141.0 

Malignant neoplasm of other and unspecified parts of CO2 141.1-141.9 tongue 

Dorsal surface of tonque • C02.0 • 141.1 

• 

• Border of tongue C02.1 • 141.2 

• 

Ventral surface of tonque C02.2 • 141.3 • • 

• Anterior two-thirds of tongue, part unspecified • C02.3 • 141.4 

• Lingual tonsil • C02.4 • 141.6 

• Overlapping lesion of tongue C02.B • 141.5,141.B • 

• Tongue, unspecified • C02.9 • 141.9 

Malignant neoplasm of parotid gland C07 142.0 

Malignant neoplasm of other and unspecified major COS 142.1-142.9 salivary glands 

• Submandibular gland • C08.0 • 142.1 

· Sublinqual qland · COB.1 · 142.2 

• Overlapping lesion of major salivary glands • COB.8 • 142.B 

• Major salivary gland, unspecified • COB.9 • 142.9 

Malignant neoplasm of floor of mouth C04 144 

· Anterior floor of mouth · C04.0 · 144.0 

• Lateral floor of mouth • C04.1 • 144.1 

• Overlapping lesion of floor of mouth • C04.B • 144.B 

• Floor of mouth, unspecified • C04.9 • 144.9 

Malignant neoplasm of gum C03 143 

• Upper gum • C03.0 • 143.0 

• Lower gum • C03.1 • 143.1 

• Gum, unspecified • C03.9 • 143.B-143.9 
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Malignant neoplasm of palate COS 14S.2-14S.S 

• Hard palate 

COS.O • 14S.2 • 

• Soft palate 

COS.1 • 145.3 • 

• Uvula 

COS.2 • 145.4 • 

• Overlapping lesion of palate 

C05.8 • 145.5 • 

• Palate, unspecified 

• C05.9 • 145.5 

Malignant neoplasm of other and unspecified parts of C06 14S.0-14S.114S.6, 

mouth 14S.8-14S.9 

• Cheek mucosa • C06.0 • 145.0 

• Vestibule of mouth • C06.1 • 145.1 

• Retromolar area • C06.2 • 145.6 

• Overlapping lesion of other and unspecified parts 145.8 of mouth C06.8 • • 

• Mouth, unspecified • C06.9 • 145.9 

Malignant neoplasm of tonsil C09 146.0-146.2 

• Tonsillar fossa • C09.0 • 146.1 

• Tonsillar pillar (anterior) (posterior) • C09.1 • 146.2 

• Overlapping lesion of tonsil C09.8 • 146.0 • 

• Tonsil. unspecified • C09.9 • 146.0 

Malignant neoplasm of oropharynx C10 146.3-146.9 

• Vallecula • C10.o • 146.3 

• Anterior surface of epiglottis • ClO.1 • 146.4 

• Lateral wall of oropharynx • C10.2 • 146.6 

• Posterior wall of oropharynx • C10.3 • 146.7 

• Branchial cleft • ClO.4 • 146.8 

• Overlapping lesion of oropharynx C10.8 • 146.5, 146.8 • 

• Oropharynx, unspecified • C10.9 • 146.9 

Malignant neoplasm of nasopharynx C11 147 

• Superior wall of nasopharynx • C11.0 • 147.0 

• Posterior wall of nasopharynx • C11.1 • 147.1 

• Lateral wall of nasopharynx • C11.2 • 147.2 

• Anterior wall of nasopharynx • C11.3 • 147.3 

• Overlapping lesion of nasopharynx • C11.8 • 147.8 

• Nasopharynx, unspecified • C11.9 • 147.9 

Malignant neoplasm of piriform sinus C12 148.1 

Malignant neoplasm of hypopharynx C13 148.0, 148.2-148.9 

• Postcricoid region • C13.0 • 148.0 

• Aryepiglottic fold, hypopharyngeal aspect • C13.1 • 148.2 
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• Posterior wall of hypopharynx • C13.2 • 148.3 

• Overlapping lesion of hypopharynx • C13.8 • 148.8 

• Hypopharynx, unspecified • C13.9 • 148.9 

Malignant neoplasms of other and ill-defined conditions in C14 149 the lip, oral cavity and pharynx 

• Pharynx, unspecified C14.0 • 149.0 • 

• Waldeyer's ring • C14.2 • 149.1 

• Overlapping lesion of lip, oral cavity and pharynx C14.8 • 149.8,149.9 • 

Malignant neoplasm of nasal cavity C30.0 160.0 

Malignant neoplasm of accessory sinuses C31 160.2-160.9 

• Maxillary sinus • C31.0 • 160.2 

• Ethmoidal sinus • C31.1 • 160.3 

• Frontal sinus • C31.2 • 16004 

• Sphenoidal sinus • C31.3 • 160.5 

• Overlapping lesion of accessory sinuses • C31.8 • 160.8 

• Accessory sinus, unspecified • C31.9 • 160.9 

Malignant neoplasm of larynx C32 161 

• Glottis • C32.0 • 161.0 

• Supraglottis • C32.1 • 161.1 

• Subglottis • C32.2 • 161.2 

• Laryngeal cartilage • C32.3 • 161.3 

• Overlapping lesion of larynx • C32.8 • 161.8 

• Larynx, unspecified • C32.9 • 161.9 

Digestive Malignant neoplasm of the esophagus C15 150 

System • Cervical part of esophagus • C15.0 • 150.0 

• Thoracic part of esophagus • C15.1 • 150.1 

• Abdominal part of esophagus • C15.2 • 150.2 

• Upper third of esophagus • C15.3 • 150.3 

• Middle third of esophagus • C15A • 15004 

• Lower third of esophagus • C15.5 • 150.5 

• Overlapping lesion of esophagus • C15.8 • 150.8 

• Esophagus, unspecified • C15.9 • 150.9 

Malignant neoplasm of the stomach C16 151 

• Cardia • C16.0 • 151.0 

• Fundus of stomach • C16.1 • 151.3 

• Body of stomach • C16.2 • 15104 

• Pyloric antrum • C16.3 • 151.2 

• Pylorus • C16A • 151.1 

• Lesser curvature of stomach, unspecified • C16.5 • 151.5 

• Greater curvature of stomach, unspecified • C16.6 • 151.6 

• Overlappinq lesion of stomach • C16.8 • 151.8 

• Stomach, unspecified • C16.9 • 151.9 

Malignant neoplasm of colon C18 153 

• Caecum • C18.0 • 15304 

• Appendix • C18.1 • 153.5 

• Ascending colon • C18.2 • 153.6 

• Hepatic flexure • C18.3 • 153.0 

• Transverse colon • C18A • 153.1 

• Splenic flexure • C18.5 • 153.7 
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• Descending colon • C18.6 • 153.2 

• Sigmoid colon • C18.7 • 153.3 

• Overlapping lesion of colon • C18.8 • 153.8 

• Colon, unspecified • C18.9 • 153.9 

Malignant neoplasm of rectosigmoid junction C19 154.0 

Malignant neoplasm of rectum C20 154.1, 154.8 

Malignant neoplasm of other and ill-defined digestive C26.0, C26.8- 159.0, 159.8, 159.9 

organs C26.9 

• Intestinal tract, part unspecified • C26.0 • 159.0 

• OverlappinQ lesion of diQestive system • C26.8 • 159.8 

• III-defined sites within the diqestive system • C26.9 • 159.9 

Malignant neoplasm of liver and Intrahepatic bile ducts C22 155 

• Liver cell carcinoma • C22.0 • 155.0 

• Intrahepatic bile duct carcinoma • C22.1 • 155.1 

• Hepatoblastoma • C22.2 • 155.0 

• Angiosarcoma of liver • C22.3 • 155.0 

• Other sarcomas of liver • C22.4 • 155.0 

• Other specified carcinomas of liver • C22.7 • 155.0 

• Liver, unspecified • C22.9 • 155.2 

Malignant neoplasm of retroperitoneum and peritoneum C48 158 

Retroperitoneum • • C48.0 • 158.0 

Specified parts of peritoneum • • C48.1 • 158.8 

• Peritoneum, unspecified • C48.2 • 158.9 

• Overlapping lesion of retroperitoneum and 158.8 peritoneum C48.8 • • 

Respiratory Malignant neoplasm of trachea C33 162.0 

System 

Malignant neoplasm of bronchus and lung C34 162.2-162.9 

Main bronchus • • 

C34.0 • 162.2 

Upper lobe, bronchus or lunq • • C34.1 • 162.3 

Middle lobe, bronchus or lunq • • 

C34.2 • 162.4 

Lower lobe, bronchus or lunq • • C34.3 • 162.5 

Overlapping lesion of bronchus and lung • • C34.8 • 162.8 

Bronchus or lunq, unspecified • • C34.9 • 162.9 

Malignant neoplasm of heart, mediastinum and pleura C38 164.1 -164.9, 163 

Heart • • C38.0 • 164.1 

Anterior mediastinum • • 

C38.1 • 164.2 

Posterior mediastinum • • C38.2 • 164.3 

Mediastinum, part unspecified • • C38.3 • 164.9 

Pleura • • C38.4 • 163.0-163.9 
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• Overlapping lesion of heart, mediastinum and • C38.8 • 164.8 

pleura 

Malignant neoplasm of other and ill-defined sites in the C39 165 respiratory system and intrathoracic organs 

• Upper respiratory tract, part unspecified • C39.0 • 165.0 

• Overlapping lesion of respiratory and intrathoracic C39.8 165.8 orqans • • 

• III-defined sites within the respiratory system • C39.9 • 165.9 

Mesothelium Mesothelioma C45 158.8,163.9,164.1 

• Mesothelioma of pleura • C45.0 • 163.9 

• Mesothelioma of peritoneum • C45.1 • 158.8 

• Mesothelioma of pericardium • C45.2 • 164.1 

• Mesothelioma of other sites • C45.7 No Code 

• Mesothelioma, unspecified • C45.9 No Code 

Soft Tissue Malignant neoplasm of peripheral nerves and autonomic C47 171 nervous system 

• Peripheral nerves of head, face and neck • C47.0 • 171.0 

• Peripheral nerves of upper limb, including shoulder 

• C47.1 • 171.2 

• Peripheral nerves of lower limb, including hip • C47.2 • 171.3 

• Peripheral nerves of thorax 

• C47.3 • 171.4 

• Peripheral nerves of abdomen • C47.4 • 171.5 

• Peripheral nerves of pelvis • C47.5 • 171.6 

• Peripheral nerves of trunk, unspecified • C47.6 • 171.7 

• Overlapping lesion of peripheral nerves and 171.8 autonomic nervous system C47.8 • • 

• Peripheral nerves and autonomic nervous system, 171.9 unspecified C47.9 • • 

Malignant neoplasm of other connective and soft tissue C49 171 

• Connective and soft tissue of head, face and neck 

• C49.0 • 171.0 

• Connective and soft tissue of upper limb, including • 171.2 shoulder • C49.1 

• Connective and soft tissue of lower limb, including 171.3 hip C49.2 • • 

• Connective and soft tissue of thorax • C49.3 • 171.4 

• Connective and soft tissue of abdomen 

• C49.4 • 171.5 

• Connective and soft tissue of pelvis • C49.5 • 171.6 

• Connective and soft tissue of trunk, unspecified • C49.6 • 171.7 

• Overlapping lesion of connective and soft tissue 

• C49.8 • 171.8 

• Connective and soft tissue, unspecified C49.9 • 171.9 

• 

Skin (Non- Other malignant neoplasms of skin C44 173 

Melanoma) 

• Skin of lip • C44.0 • 173.0 

• Skin of eyelid, including canthus • C44.1 • 173.1 

• Skin of ear and external auricular canal • C44.2 • 173.2 

• Skin of other and unspecified parts of face • C44.3 • 173.3 

• Skin of scalp and neck • C44.4 • 173.4 

• Skin of trunk • C44.5 • 173.5 

• Skin of upper limb, including shoulder • C44.6 • 173.6 
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• Skin of lower limb, including hip • C44.7 • 173.7 

• Overlappinq lesion of skin • C44.8 • 173.8 

• Malignant neoplasm of skin, unspecified • C44.9 • 173.9 

Scrotum C63.2 187.7 

Melanoma Malignant melanoma of skin C43 172 

• Malignant melanoma of lip • C43.0 • 172.0 

• Malignant melanoma of eyelid, including canthus • C43.1 • 172.1 

• Malignant melanoma of ear and external auricular C43.2 172.2 canal • • 

• Malignant melanoma of other and unspecified C43.3 172.3 parts of face • • 

• Malignant melanoma of scalp and neck • C43A • 17204 

• Malignant melanoma of trunk • C43.S • 172.S 

• Malignant melanoma of upper limb, including C43.6 172.6 shoulder • • 

• Malignant melanoma of lower limb, including hip • C43.7 • 172.7 

• Overlapping malignant melanoma of skin • C43.8 • 172.8 

• Malignant melanoma of skin, unspecified • C43.9 • 172.9 

Female Breast Malignant neoplasm of breast C50+ 174 

• Nipple and areola • CSO.O • 174.0 

• Central portion of breast • CSO.1 • 174.1 

• Upper-inner quadrant of breast • CSO.2 • 174.2 

• Lower-inner quadrant of breast • CSO.3 • 174.3 

• Upper-outer quadrant of breast • CSOA • 17404 

• Lower-outer quadrant of breast • CSO.S • 174.S 

• Auxiliary tail of breast • CSO.6 • 174.6 

• Overlappinq lesion of breast • CSO.8 • 174.8 

• Breast, unspecified • CSO.9 • 174.9 

Female 

Reproductive Malignant neoplasm of ovary C56 183.0 

Organs 

Urinary System Malignant neoplasm of prostate C61 185 

Malignant neoplasm of bladder C67 188 

• Trigone of bladder • C67.0 • 188.0 

• Dome of bladder • C67.1 • 188.1 

• Lateral wall of bladder • C67.2 • 188.2 

• Anterior wall of bladder • C67.3 • 188.3 

• Posterior wall of bladder • C67Ad • 18804 

• Bladder neck • C67.S • 188.S 

• Ureteric orifice • C67.6 • 188.6 

• Urachus • C67.7 • 188.7 

• Overlappinq lesion of bladder • C67.8 • 188.8 

• Bladder, unspecified • C67.9 • 188.9 

Malignant neoplasms of kidney except renal pelvis C64 189.0 

Malignant neoplasm of renal pelvis C65 189.1 

Malignant neoplasm of ureter C66 189.2 

Malignant neoplasm of other and unspecified urinary C68 189.3-189.9 

organs 
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• Urethra • C68.0 • 189.3 

• Paraurethral gland • C68.1 • 189.4 

• Overlapping lesion of urinary organs • C68.8 • 189.8 

• Urinary organ, unspecified • C68.9 • 189.9 

Eye & Orbit Malignant neoplasm of eye and adnexa C69 190 

• Conjunctiva • C69.0 • 190.3 

• Cornea • C69.1 • 190.4 

• Retina • C69.2 • 190.5 

• Choroid • C69.3 • 190.6 

• Ciliary body • C69.4 • 190.0 

• Lacrimal gland and duct • C69.S • 190.2, 190.7 

• Orbit • C69.6 • 190.1 

• Overlapping lesion of eye and adnexa • C69.8 • 190.8 

• Eye, unspecified • C69.9 • 190.9 

Thyroid Malignant neoplasm of thyroid gland C73 193 

Blood & Hodgkin's disease C81 * 

Lymphoid Tissue 

• Lymphocytic predominance • C81.0 • 201.4 

• Nodular sclerosis • C8Ll • 201.5 

• Mixed cellularity • C81.2 • 201.6 

• Lymphocytic depletion • C81.3 • 201.7 

• Other Hodgkin's disease • C81.7 • 201.0-201.2 

• Hodgkin's disease, unspecified • C81.9 • 201.9 

Follicular [nodular] non-Hodgkin lymphoma C82 * 

• Small cleaved cell. follicular • C82.0 • 202.0 

• Mixed small cleaved and large cell, follicular • C82.1 • 202.0 

• Large cell, follicular • C82.2 • 202.0 

• Other types of follicular non-Hodgkin lymphoma • C82.7 • 202.0 

• Follicular non-Hodgkin lymphoma, unspecified • C82.9 • 202.0 

Diffuse non-Hodgkin lymphoma C83 * 

• Small cell (diffuse) • C83.0 • 200.8 

• Small cleaved cell (diffuse) • C83.1 • 202.4 

• Mixed small and large cell (diffuse) • C83.2 • 200.8 

• Large cell (diffuse) • C83.3 • 200.0 

• Immunoblastic (diffuse) • C83.4 • 200.8 

• Lymphoblastic (diffuse) • C83.S • 200.1 

• Undifferentiated (diffuse) • C83.6 • 202.8 

• Burkitt's tumor • C83.7 • 200.2 

• Other types of diffuse non-Hodgkin lymphoma • C83.8 • 200.8 

• Diffuse non-Hodgkin lymphoma, unspecified • C83.9 • 202.0 

Peripheral and cutaneous T -cell lymphomas C84 * 

• Mycosis fungoides • C84.0 • 202.1 

• Sezary's disease • C84.1 • 202.2 

• T-zone lymphoma • C84.2 • 202.8 

• Lymphoepithelioid lymphoma • C84.3 • 202.8 

• Peripheral T-cell lymphoma • C84.4 • 202.0 

• Other and unspecified T-cell lymphomas • C84.S • 202.0 

Other and unspecified types of non-Hodgkin lymphoma C85 * 

• Lymphosarcoma • C8S.0 • 200.1 

• B-ceillymphoma, unspecified • C8S.1 • 202.8 

• Other specified types of non-Hodgkin lymphoma • C8S.7 • 202.8 
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• Non-Hodgkin lymphoma, unspecified type • C8S.9 • 200.8 

Malignant immunoproliferative diseases C88 * 

• Waldenstrom's macroglobulinemia • C88.0 • 273.3 

• Alpha heavy chain disease • C88.1 • 203.8 

• Gamma heavy chain disease • C88.2 • 203.8 

• Immunoproliferative small intestinal disease • C88.3 • 203.8 

• Other malignant immunoproliferative diseases • C88.7 • 203.8 

• Malignant immunoproliferative disease, unspecified • C88.9 • 203.8 

Multiple myeloma and malignant plasma cell neoplasms C90 * 

• Multiple myeloma • C90.0 • 203.0 

• Plasma cell leukemia • C90.1 • 203.1 

• Plasmacytoma, extramedullary • C90.2 • 203.8 

Lymphoid leukemia C91 * 

• Acute lymphoblastic leukemia • C91.0 • 204.0 

• Chronic lymphocytic leukemia • C91.1 • 204.1 

• Subacute lymphocytic leukemia • C91.2 • 204.2 

• Prolymphocytic leukemia • C91.3 • 204.9 

• Hairy-cell leukemia • C91.4 • 202.4 

• Adult T-cell leukemia • C91.S • 204.8 

• Other lymphoid leukemia • C91.7 • 204.8 

• Lymphoid leukemia, unspecified • C91.9 • 204.9 

Myeloid leukemia C92 * 

• Acute myeloid leukemia • C92.0 • 20S.0 

• Chronic myeloid leukemia • C92.1 • 20S.1 

• Subacute myeloid leukemia • C92.2 • 20S.2 

• Myeloid sarcoma • C92.3 • 20S.3 

• Acute promyelocytic leukemia • C92.4 • 20S.0 

• Acute myelomonocytic leukemia • C92.S • 20S.0 

• Other myeloid leukemia • C92.7 • 20S.8 

• Myeloid leukemia, unspecified • C92.9 • 20S.9 

Monocytic leukemia C93 * 

• Acute monocytic leukemia • C93.0 • 206.0 

• Chronic monocytic leukemia • C93.1 • 206.1 

• Subacute monocytic leukemia • C93.2 • 206.2 

• Other monocytic leukemia • C93.7 • 206.8 

• Monocytic leukemia, unspecified • C93.9 • 206.9 

Other leukemias of specified cell type C94 * 

• Acute erythremia and erythroleukemia • C94.0 • 207.0 

• Chronic erythremia • C94.1 • 207.1 

• Acute megakaryoblastic leukemia • C94.2 • 207.2 

• Mast cell leukemia • C94.3 • 207.8 

• Acute pan myelosis • C94.4 • 238.7 

• Acute myelofibrosis • C94.S • 238.7 

• Other specified leukemias • C94.7 • 207.8 

Leukemia of unspecified cell type C95 * 

• Acute leukemia of unspecified cell type • C9S.0 • 208.0 

• Chronic leukemia of unspecified cell type • C9S.1 • 208.1 

• Subacute leukemia of unspecified cell type • C9S.2 • 208.2 

• Other leukemia of unspecified cell type • C9S.7 • 208.8 

• Leukemia, unspecified • C9S.9 • 208.9 

Other and unspecified malignant neoplasms of lymphoid, C96 * hematopoietic and related tissue 
Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Rules and Regulations 57523 

* * * * * 

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 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2013–0002; Internal 

Agency Docket No. FEMA–8301] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP) that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur and 

a notice of this will be provided by 

publication in the Federal Register on a 

subsequent date. Also, information 

identifying the current participation 

status of a community can be obtained 

from FEMA’s Community Status Book 

(CSB). The CSB is available at http://

www.fema.gov/fema/csb.shtm. 

DATES: Effective Dates: The effective 

date of each community’s scheduled 

suspension is the third date (‘‘Susp.’’) 

listed in the third column of the 

following tables. 

FOR FURTHER INFORMATION CONTACT: If 

you want to determine whether a 

particular community was suspended 

on the suspension date or for further 

information, contact David Stearrett, 

Federal Insurance and Mitigation 

Administration, Federal Emergency 

Management Agency, 500 C Street SW., 

Washington, DC 20472, (202) 646–2953. 

SUPPLEMENTARY INFORMATION: The NFIP 

enables property owners to purchase 

Federal flood insurance that is not 

otherwise generally available from 

private insurers. In return, communities 

agree to adopt and administer local 

floodplain management measures aimed 

at protecting lives and new construction 

from future flooding. Section 1315 of 

the National Flood Insurance Act of 

1968, as amended, 42 U.S.C. 4022, 

prohibits the sale of NFIP flood 

insurance unless an appropriate public 

body adopts adequate floodplain 

management measures with effective 

enforcement measures. The 

communities listed in this document no 

longer meet that statutory requirement 

for compliance with program 

regulations, 44 CFR Part 59. 

Accordingly, the communities will be 

suspended on the effective date in the 

third column. As of that date, flood 

insurance will no longer be available in 

the community. We recognize that some 

of these communities may adopt and 

submit the required documentation of 

legally enforceable floodplain 

management measures after this rule is 

published but prior to the actual 

suspension date. These communities 

will not be suspended and will continue 

to be eligible for the sale of NFIP flood 

insurance. A notice withdrawing the 

suspension of such communities will be 

published in the Federal Register. 

In addition, FEMA publishes a Flood 

Insurance Rate Map (FIRM) that 

identifies the Special Flood Hazard 

Areas (SFHAs) in these communities. 

The date of the FIRM, if one has been 

published, is indicated in the fourth 

column of the table. No direct Federal 

financial assistance (except assistance 

pursuant to the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act not in connection with a 

flood) may be provided for construction 

or acquisition of buildings in identified 

SFHAs for communities not 

participating in the NFIP and identified 

for more than a year on FEMA’s initial 

FIRM for the community as having 

flood-prone areas (section 202(a) of the 

Flood Disaster Protection Act of 1973, 

42 U.S.C. 4106(a), as amended). This 

prohibition against certain types of 

Federal assistance becomes effective for 

the communities listed on the date 

shown in the last column. The 

Administrator finds that notice and 

public comment procedures under 5 

U.S.C. 553(b), are impracticable and 

unnecessary because communities listed 

in this final rule have been adequately 

notified. 


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