[Federal Register Volume 79, Number 87 (Tuesday, May 6, 2014)]
[Proposed Rules]
[Pages 25766-25767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10434]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88


World Trade Center Health Program; Petition 004--Cardiovascular 
Disease; Finding of Insufficient Evidence

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Denial of petition for addition of a health condition.

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SUMMARY: On March 7, 2014, the Administrator of the World Trade Center 
(WTC) Health Program received a petition (Petition 004) to add ``heart 
attack,'' which the Administrator has interpreted to mean 
``cardiovascular disease,'' to the List of WTC-Related Health 
Conditions (List). Upon reviewing the scientific and medical 
literature, including information provided by the petitioner, the 
Administrator has determined that the available evidence does not have 
the potential to provide a basis for a decision on whether to add 
cardiovascular disease to the List. The Administrator finds that 
insufficient evidence exists to request a recommendation of the WTC 
Health Program Scientific/Technical Advisory Committee (STAC), to 
publish a proposed rule, or to publish a determination not to publish a 
proposed rule.

DATES: The Administrator of the WTC Health Program is denying this 
petition for the addition of a health condition as of May 6, 2014.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 4674 
Columbia Parkway, MS: C-46, Cincinnati, OH 45226; telephone (855) 818-
1629 (this is a toll-free number); email [email protected].

SUPPLEMENTARY INFORMATION: 

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 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.
    Pursuant to section 3312(a)(6)(B) of the PHS Act, interested 
parties may petition the Administrator to add a health condition to the 
List in 42 CFR 88.1. Within 60 calendar days after receipt of a 
petition to add a condition to the List, the Administrator must take 
one of the following four actions described in section 3312(a)(6)(B) 
and 42 CFR 88.17: (i) Request a recommendation of the STAC; (ii) 
publish a proposed rule in the Federal Register to add such health 
condition; (iii) publish in the Federal Register the Administrator's 
determination not to publish such a proposed rule and the basis for 
such determination; or (iv) publish in the Federal Register a 
determination that insufficient evidence exists to take action under 
(i) through (iii) above.

B. Petition 004

    On March 7, 2014, the Administrator received a petition to add 
``heart attack'' to the List (Petition 004).\2\ The petition was 
submitted by a WTC Health Program member who responded to the September 
11, 2001 terrorist attacks in New York City. The petitioner indicated 
that he has been diagnosed with a number of WTC-related health 
conditions, and has suffered a heart attack. Also included in his 
petition was a press release published by the New York City Department 
of Health and Mental Hygiene describing a WTC Health Registry study 
authored by Hannah T. Jordan et al. and published

[[Page 25767]]

in the Journal of the American Heart Association on October 24, 
2013.\3\
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    \2\ See Petition 004. WTC Health Program: Petitions Received. 
http://www.cdc.gov/wtc/received.html.
    \3\ Jordan HT, Stellman SD, Morabia A, Miller-Archie SA, Alper 
H, Laskaris Z, Brackbill RM, and Cone JE [2013] Cardiovascular 
disease hospitalizations in relation to exposure to the September 
11, 2001 World Trade Center disaster and posttraumatic stress 
disorder. Journal of the American Heart Association 2(5).
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C. Administrator's Determination on Petition 004

    The Administrator has established a methodology for evaluating 
whether to add non-cancer health conditions to the List of WTC-Related 
Health Conditions.\4\ A health condition may be added to the List if 
published, peer-reviewed epidemiologic evidence provides substantial 
support for a causal relationship between 9/11 exposures and the health 
condition in 9/11-exposed populations.\5\ If the epidemiologic evidence 
provides modest support for a causal relationship between 9/11 
exposures and the health condition, the Administrator may then evaluate 
studies of associations between the health condition and 9/11 agents in 
similarly-exposed populations.\6\ If that additional assessment 
establishes substantial support for a causal relationship between a 9/
11 agent or agents and the health condition, the health condition may 
be added to the List.
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    \4\ This methodology, ``Policy and Procedures for Adding Non-
Cancer Conditions to the List of WTC-Related Health Conditions,'' is 
available on the WTC Health Program Web site, at http://www.cdc.gov/wtc/policies.html.
    \5\ The substantial evidence standard is met when the Program 
assesses all of the available, relevant information and determines 
with high confidence that the evidence supports its findings 
regarding a causal association between the 9/11 exposure(s) and the 
health condition.
    \6\ The modest evidence standard is met when the Program 
assesses all of the available, relevant information and determines 
with moderate confidence that the evidence supports its findings 
regarding a causal association between the 9/11 exposure(s) and the 
health condition.
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    In accordance with section 3312(a)(6)(B) of the PHS Act, 42 CFR 
88.17, and the methodology for the addition of non-cancer health 
conditions, the Administrator reviewed the evidence presented in 
Petition 004. Although the petitioner requested the addition of ``heart 
attack,'' the Administrator determined that the more appropriate health 
condition is ``cardiovascular disease,'' which includes heart attack, 
acute or chronic coronary artery disease, cardiac arrhythmia, angina, 
and any other heart condition. The Administrator then selected a team 
under the direction of the WTC Health Program Associate Director for 
Science (ADS) to perform a systematic literature search and provide 
input on whether the available scientific and medical information has 
the potential to provide a basis for a decision on whether to add the 
health condition to the List. The ADS conducted a search of the 
existing scientific/medical literature for epidemiologic evidence of a 
causal relationship between 9/11 exposures and cardiovascular disease. 
Among the studies identified by the literature search, four were found 
to be published, peer-reviewed epidemiologic studies of 9/11-exposed 
populations.\7\ However, when reviewed by the ADS for relevance, 
quantity, and quality, each of the four published, peer-reviewed 
epidemiologic studies of 9/11-exposed populations were found to have 
significant limitations, both individually and in combination. 
Limitations of the four studies included selection, recall, and 
confounding bias \8\; poor generalizability among all exposed groups; 
and lack of consistency among the associations reported between 9/11 
exposures and cardiovascular disease between studies. Thus, the ADS 
concluded that the available information did not have the potential to 
form the basis for a decision on whether to propose adding 
cardiovascular disease to the List.
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    \7\ 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, World 
Trade Center disaster: results from the World Trade Center Health 
Registry cohort. The Lancet 378: 879-87; Jordan HT, Miller-Archie 
SA, Cone JE, Morabia A, Stellman SD [2011]. Heart disease among 
adults exposed to the September 11, 2001 World Trade Center 
disaster: Results from the World Trade Center Health Registry. 
Preventive Medicine 53:370-376; Jordan HT, Stellman SD, Morabia A, 
Miller-Archie SA, Alper H, Laskaris Z, Brackbill RM, Cone JE [2013]. 
Cardiovascular Disease Hospitalizations in Relation to Exposure to 
the September 11, 2001 World Trade Center Disaster and Posttraumatic 
Stress Disorder. J Am Heart Assoc; Brackbill RM, Cone JE, Farfel MR, 
Stellman SD [2014]. Chronic Physical Health Consequences of Being 
Injured During the Terrorist Attacks on World Trade Center on 
September 11, 2001. American Journal of Epidemiology. Advance Access 
published February 20, 2014.
    \8\ In this case, ``selection bias'' refers to study populations 
that include individuals who were self-identified as heart patients 
but whose reported illness was not independently verified; ``recall 
bias'' refers to the inaccuracies or incompleteness inherent in the 
self-reporting of 9/11-related health conditions years after the 
event; and ``confounding bias'' refers to the existence of risk 
factors for cardiovascular disease that have not been accounted for 
by study authors.
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    The findings described above led the Administrator to determine 
that insufficient evidence exists to take further action, including 
either proposing the addition of cardiovascular disease to the List 
(pursuant to PHS Act, section 3312(a)(6)(B)(ii) and 42 CFR 
88.17(a)(2)(ii)) or publishing a determination not to publish a 
proposed rule in the Federal Register (pursuant to PHS Act, section 
3312(a)(6)(B)(iii) and 42 CFR 88.17(a)(2)(iii)). The Administrator has 
also determined that requesting a recommendation from the STAC 
(pursuant to PHS Act, section 3312(a)(6)(B)(i) and 42 CFR 
88.17(a)(2)(i)) is unwarranted.
    For the reasons discussed above, the request made in Petition 004 
to add cardiovascular disease to the List of WTC-Related Health 
Conditions is denied.

    Dated: May 1, 2014.
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. 2014-10434 Filed 5-5-14; 8:45 am]
BILLING CODE 4163-18-P