25766 Federal Register / Vol. 79, No. 87 / Tuesday, May 6, 2014 / Proposed Rules 

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. 

2See Petition 004. WTC Health Program: Petitions 

Received. http://www.cdc.gov/wtc/received.html. 

§ 165.T07–0165 Safety Zones; July 4th 

Fireworks Displays within the Captain of the 

Port Miami Zone, FL. 

(a) Regulated Areas. The following 

regulated areas are safety zones. All 

coordinates are North American Datum 

1983. 

(1) Stuart, FL. All waters within a 400 

yard radius around the barge from 

which the fireworks will be launched, 

located on the St. Lucie River north of 

City Hall at approximate position 

27°12′09′′ N, 80°14′20′′ W. 

(2) West Palm Beach, FL. All waters 

within a 300 yard radius around the 

barge from which the fireworks will be 

launched, located on the Intracoastal 

Waterway north of the Royal Palm 

Bridge at approximate position 

26°42′36′′ N, 80°02′45′′ W. 

(3) Miami, FL. All waters within a 400 

yard radius around the barge from 

which the fireworks will be launched, 

located on the waters of Biscayne Bay 

east of Bayfront Park at approximate 

position 25°46′30′′ N, 80°10′56′′ W. 

(b) Definition. The term ‘‘designated 

representative’’ means Coast Guard 

Patrol Commanders, including Coast 

Guard coxswains, petty officers, and 

other officers operating Coast Guard 

vessels, and Federal, state, and local 

officers designated by or assisting the 

Captain of the Port Miami in the 

enforcement of the regulated areas. 

(c) Regulations. 

(1) All non-participant persons and 

vessels are prohibited from entering, 

transiting through, anchoring in or 

remaining within the safety zones 

unless authorized by the Captain of the 

Port Miami or a designated 

representative. 

(2) Non-participant persons and 

vessels desiring to enter, transit through, 

anchor in, or remain within a regulated 

area may contact the Captain of the Port 

Miami by telephone at 305–535–4472, 

or a designated representative via VHF 

radio on channel 16. If authorization to 

enter, transit through, anchor in, or 

remain within a regulated area is 

granted by the Captain of the Port 

Miami or a designated representative, 

all persons and vessels receiving such 

authorization must comply with the 

instructions of the Captain of the Port 

Miami or a designated representative. 

(3) The Coast Guard will provide 

notice of the safety zones by Local 

Notice to Mariners, Broadcast Notice to 

Mariners, and on-scene designated 

representatives. 

(d) Effective Date. This rule is 

effective on July 4, 2014. This rule will 

be enforced from 8:30 p.m. until 10:15 

p.m. on July 4, 2014. 

Dated: April 10, 2014. 

A.J. Gould, 

Captain, U.S. Coast Guard, Captain of the 

Port Miami. 

[FR Doc. 2014–10270 Filed 5–5–14; 8:45 am] 

BILLING CODE 9110–04–P 

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. 

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 NIOSHregs@cdc.gov. 

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. 

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 


sroberts on DSK5SPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 87 / Tuesday, May 6, 2014 / Proposed Rules 25767 

3 Jordan HT, Stellman SD, Morabia A, MillerArchie 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). 

4This methodology, ‘‘Policy and Procedures for 

Adding Non-Cancer Conditions to the List of WTCRelated Health Conditions,’’ is available on the 

WTC Health Program Web site, at http://

www.cdc.gov/wtc/policies.html. 

5The 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. 

6The 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. 

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 selfidentified 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. 

in the Journal of the American Heart 

Association on October 24, 2013.3

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. 

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. 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 488 

[CMS–1605–P] 

RIN 0938–AS07 

Medicare Program; Prospective 

Payment System and Consolidated 

Billing for Skilled Nursing Facilities for 

FY 2015 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

update the payment rates used under 

the prospective payment system (PPS) 

for skilled nursing facilities (SNFs) for 

fiscal year (FY) 2015. In addition, it 

includes a proposal to adopt the most 

recent Office of Management and 

Budget (OMB) statistical area 

delineations to identify a facility’s urban 

or rural status for the purpose of 

determining which set of rate tables 

would apply to the facility and to 

determine the SNF PPS wage index 

including a proposed one-year 

transition with a blended wage index for 

all providers for FY 2015. It also 

includes a discussion of the SNF 

therapy payment research currently 

underway within CMS. This proposed 

rule also proposes a revision to policies 

related to the Change of Therapy (COT) 

Other Medicare Required Assessment 

(OMRA). This proposed rule includes a 

discussion of a provision related to the 


sroberts on DSK5SPTVN1PROD with PROPOSALS