Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations 18855 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address 

disproportionate human health or 

environmental effects with practical, 

appropriate, and legally permissible 

methods under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the State, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by May 28, 2013. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this action for 

the purposes of judicial review nor does 

it extend the time within which a 

petition for judicial review may be filed, 

and shall not postpone the effectiveness 

of such rule or action. Parties with 

objections to this direct final rule are 

encouraged to file a comment in 

response to the parallel notice of 

proposed rulemaking for this action 

published in the Proposed Rules section 

of today’s Federal Register, rather than 

file an immediate petition for judicial 

review of this direct final rule, so that 

EPA can withdraw this direct final rule 

and address the comment in the 

proposed rulemaking. This action may 

not be challenged later in proceedings to 

enforce its requirements (see section 

307(b)(2)). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Volatile organic compounds. 

Dated: January 25, 2013. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

Part 52, Chapter I, Title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for Part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart F—California 

■ 2. Section 52.220 is amended by 

adding paragraph (c)(411)(i)(F) to read 

as follows: 

§ 52.220 Identification of plan. 

* * * * * 

(c) * * * 

(411) * * * 

(i) * * * 

(F) South Coast Air Quality 

Management District. 

(1) Rule 463, ‘‘Organic Liquid 

Storage,’’ amended on November 4, 

2011. 

* * * * * 

[FR Doc. 2013–06423 Filed 3–27–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 88 

[Docket No. CDC–2013–0002; NIOSH–261] 

RIN 0920–AA48 

World Trade Center Health Program 

Eligibility Requirements for 

Shanksville, Pennsylvania and 

Pentagon Responders 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Interim final rule with request 

for comments. 

SUMMARY: Title I of the James Zadroga 

9/11 Health and Compensation Act of 

2010 amended the Public Health Service 

Act (PHS Act) by adding Title XXXIII, 

which establishes the World Trade 

Center (WTC) Health Program. The WTC 

Health Program is administered by the 

Director of the National Institute for 

Occupational Safety and Health 

(NIOSH), within the Centers for Disease 

Control and Prevention (CDC), in the 

Department of Health and Human 

Services (HHS), and provides medical 

monitoring and treatment to eligible 

firefighters and related personnel, law 

enforcement officers, and rescue, 

recovery, and cleanup workers who 

responded to the September 11, 2001, 

terrorist attacks in New York City, 

Shanksville, Pennsylvania, and at the 

Pentagon, and to eligible survivors of 

the New York City attacks. Section 

3311(a)(2)(C) of the PHS Act requires 

the WTC Program Administrator 

(Administrator) to develop eligibility 

criteria for enrollment of Shanksville, 

Pennsylvania and Pentagon responders. 

This interim final rule establishes those 

eligibility criteria. 

DATES: This interim final rule will be 

effective May 1, 2013. HHS invites 

written comments from interested 

parties on this interim final rule and on 

the information collection approval 

request sought under the Paperwork 

Reduction Act. Comments must be 

received by April 30, 2013. 

ADDRESSES: You may submit comments, 

identified by ‘‘RIN 0920–AA48,’’ by 

either of the following methods: 

• Internet: Access the Federal erulemaking portal at http:// 

www.regulations.gov. Follow the 

instructions for submitting comments to 

Docket No. CDC–2013–0002. 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

Instructions: All submissions received 

must include the agency name and 

docket number or Regulation Identifier 

Number (RIN) for this rulemaking. All 

relevant comments will be posted 

without change to http:// 

www.regulations.gov and http:// 

www.cdc.gov/niosh/docket/review/ 

docket261/default.html, including any 

personal information provided. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Public Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, please go to 

http://www.regulations.gov or http:// 


srobinson on DSK4SPTVN1PROD with RULES
18856 Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations 

www.cdc.gov/niosh/docket/review/ 

docket261/default.html. 

FOR FURTHER INFORMATION CONTACT: 

Frank J. Hearl, PE, Chief of Staff, 

National Institute for Occupational 

Safety and Health, Centers for Disease 

Control and Prevention, Patriots Plaza, 

Suite 9200, 395 E St. SW., Washington, 

DC 20201. Telephone: (202) 245–0625 

(this is not a toll-free number). Email: 

WTCpublicinput@cdc.gov. 

SUPPLEMENTARY INFORMATION: This 

notice is organized as follows: 

I. Executive Summary 

II. Public Participation 

III. Background 

A. WTC Health Program History 

B. Statutory Authority 

C. Summary of WTC Health Program 

Findings: Evidence Concerning 

Eligibility Criteria for Pentagon and 

Shanksville, Pennsylvania Responders 

IV. Issuance of an Interim Final Rule with 

Delayed Effective Date 

V. Summary of Interim Final Rule 

VI. Applying for Coverage under this Interim 

Final Rule 

VII. 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 

The WTC Health Program does not 

currently offer monitoring or treatment 

services to individuals who responded 

to the September 11, 2001, terrorist 

attacks at the Pentagon or in 

Shanksville. The statute clearly defines 

eligibility criteria for New York 

responders, whereas the Administrator 

is required to develop criteria for the 

enrollment of Pentagon and Shanksville 

responders. This rule establishes those 

eligibility criteria. Upon the effective 

date of this rule, individuals who 

believe they may be eligible for 

enrollment in the WTC Health Program 

may submit an application and 

supporting documentation. 

B. Summary of Major Provisions 

This interim final rule will establish 

eligibility criteria for the enrollment of 

responders to the September 11, 2001, 

terrorist attacks at the Pentagon and in 

Shanksville, Pennsylvania. The PHS Act 

does not allow for enrollment of 

survivors from either of the two sites. 

Therefore, survivors of the terrorist 

attacks at those sites who did not engage 

in rescue, recovery, cleanup or other 

related activities will not be eligible for 

enrollment. 

The eligibility criteria in § 88.4(b) and 

(c) apply to those individuals who were 

a member of a fire or police department 

(whether fire or emergency personnel, 

active or retired), worked for a recovery 

or cleanup contractor, or were 

volunteers; and performed rescue, 

recovery, demolition, debris cleanup, or 

other related services at either site. 

This interim final rule adds the 

definition of ‘‘police department’’ to the 

list of definitions in 42 CFR 88.1. It also 

adds definitions for ‘‘Pentagon site’’ and 

‘‘Shanksville, Pennsylvania site.’’ 

In order to establish that the 

individual is eligible for membership in 

the WTC Health Program, he or she 

must have participated in activities at 

either site for a minimum amount of 

time. Pentagon responders must have 

participated at the site for at least 1 day 

beginning September 11, 2001, and 

ending on November 19, 2001. 

Shanksville, Pennsylvania responders 

must have participated at that site for at 

least 1 day beginning September 11, 

2001, and ending on October 3, 2001. 

C. Costs and Benefits 

The total cost, transfers, and benefits 

resulting from this regulatory action are 

due to the expansion of the population 

of responders eligible to enroll in the 

WTC Health Program. For the purpose 

of this analysis, HHS assumes that 

between 540 and 1,467 Pentagon and 

Shanksville responders will enroll in 

the Program in 2013. We estimate the 

total cost of initial medical 

examinations, annual monitoring, and 

treatment for Pentagon and Shanksville 

responders to be at least $988,300 and 

no more than $3,203,400 annually 

through 2016. 

II. Public Participation 

Interested persons or organizations 

are invited to participate in this 

rulemaking by submitting written views, 

opinions, recommendations, and/or 

data. Comments are invited on any topic 

related to this interim final rule. In 

addition, HHS invites comments 

specifically on the following questions 

related to this rulemaking: 

1. The terms ‘‘Pentagon site’’ and 

‘‘Shanksville, Pennsylvania site’’ are not 

defined in the PHS Act. The 

Administrator believes it is necessary to 

define the geographic boundaries of the 

respective sites, in order to better 

identify eligible responders and has 

defined the terms in this interim final 

rule. The Administrator seeks input on 

whether the definitions are clearly 

understood and contain the locations 

that are relevant to the response 

activities. After reviewing published 

reports and anecdotal accounts of the 

events at both sites, the Administrator is 

unable to ascertain whether there may 

have been perimeter boundaries broader 

than our proposed definitions, and 

whether the proposed definitions may 

unintentionally exclude some response 

personnel who worked at the sites. We 

have identified a number of specific 

locations around the Pentagon where 

response activities occurred: the 

heliport, triage areas established on the 

lawn near S. Washington Road and 

Jefferson Davis Highway and in the 

Pentagon Center Court, and in the North 

Parking lot debris sifting area. We have 

also identified Fort Belvoir in Virginia 

and Dover Air Force Base in Delaware 

as locations where responders may have 

worked closely with victims’ remains. 

Similarly, for the Shanksville site, we 

are aware that responders transported 

remains to the Pennsylvania National 

Guard armory in Friedens. We welcome 

input from responder organizations who 

participated in Pentagon and 

Shanksville response activities 

regarding these definitions. 

2. The Administrator is establishing 

dates for the end of clean-up activities 

at each site. Based on the best available 

evidence, the rule establishes end-dates 

of November 19, 2001, for the Pentagon 

site and October 3, 2001, for the 

Shanksville, Pennsylvania site. The 

Administrator welcomes additional 

public input on these dates. 

Comments received, including 

attachments and other supporting 

materials, are part of the public record 

and subject to public disclosure. Do not 

include any information in your 

comment or supporting materials that 

you consider confidential or 

inappropriate for public disclosure. 

HHS will consider the comments 

submitted and may revise the final rule 

as appropriate. 

III. Background 

A. WTC Health Program History 

After the terrorist attacks of 

September 11, 2001, HHS, CDC, and 

NIOSH facilitated medical monitoring 

for those firefighters and related 

personnel, law enforcement officers, 

and rescue, recovery, and cleanup 

workers who responded to the terrorist 

attacks in New York City. A health 

screening program for responders that 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations 18857 

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. 

2McCleery RE [2012]. Summary of Evidence for 

Establishing Dates on which Cleanup of the 

Pentagon and Shanksville, Pennsylvania Sites of the 

Terrorist-Related Aircraft Crashes of September 11, 

2001 Concluded. Prepared for the Administrator, 

WTC Health Program. Released February 8, 2012. 

This document is available in the docket for this 

rulemaking. 

began in 2002 was expanded through a 

series of congressional appropriations, 

and in 2006 the program was re-named 

the WTC Medical Monitoring and 

Treatment Program (MMTP) to reflect 

expanded services available for 

responders. A separate NIOSH health 

program for residents, students, and 

others in the community who were 

affected by the September 11, 2001, 

terrorist attacks in New York City 

(survivors) was funded in 2008. 

Responders, including members of 

fire and police departments and others 

who conducted rescue, recovery, and 

cleanup at the September 11, 2001, 

terrorist attack sites in Shanksville, 

Pennsylvania and at the Pentagon were 

not provided services under the MMTP 

because congressional appropriations 

language did not specify inclusion of 

those groups. 

The WTC Health Program was 

established by law on January 2, 2011, 

and went into effect July 1, 2011. 

Regulations established in 42 CFR Part 

88 describe the process by which 

individuals who were firefighters and 

related personnel, law enforcement 

officers, rescue, recovery, and cleanup 

workers who responded to the 

September 11, 2001, terrorist attacks in 

New York City or survivors associated 

with the New York City attacks may be 

enrolled in the WTC Health Program. 

Part 88 also sets out the processes by 

which the Administrator makes 

enrollment determinations, certifies 

WTC-related health conditions for 

monitoring and treatment, reimburses 

providers for medically necessary 

treatment, and adds conditions to the 

List of WTC-Related Health Conditions. 

The WTC Health Program does not 

currently offer monitoring or treatment 

services to individuals who responded 

to the September 11, 2001, terrorist 

attacks at the Pentagon or in 

Shanksville. The statute clearly defines 

eligibility criteria for New York 

responders, whereas the Administrator 

is required to develop criteria for the 

enrollment of Pentagon and Shanksville 

responders. This rule establishes those 

eligibility criteria. Upon the effective 

date of this rule, individuals who 

believe they may be eligible for 

enrollment in the WTC Health Program 

may submit an application and 

supporting documentation. Information 

about applying to the WTC Health 

Program is available at http:// 

www.cdc.gov/wtc. 

B. Statutory Authority 

Title I of the James Zadroga 9/11 

Health and Compensation Act of 2010 

(Pub. L. 111–347) amended the PHS Act 

to add Title XXXIII,1 establishing the 

WTC Health Program within HHS. 

Under Title XXXIII of the PHS Act, the 

Administrator is responsible for the 

WTC Health Program. All references to 

the Administrator in this notice mean 

the NIOSH Director or his or her 

designee. 

Section 3311(a)(2)(C) of the PHS Act 

identifies a responder to the September 

11, 2001, terrorist attacks at the 

Pentagon and Shanksville, Pennsylvania 

as an individual who ‘‘was a member of 

a fire or police department (whether fire 

or emergency personnel, active or 

retired), worked for a recovery or 

cleanup contractor, or was a volunteer; 

and performed rescue, recovery, 

demolition, debris cleanup, or other 

related services.’’ The Act requires that 

the Administrator establish the dates on 

which cleanup was concluded at the 

Pentagon and Shanksville sites, 

respectively. The Administrator is also 

required under § 3311(a)(2)(C)(ii) to 

develop eligibility criteria for 

determining whether an individual 

applicant is at an increased risk of 

developing a WTC-related health 

condition as a result of exposure to 

airborne toxins, other hazards, or 

adverse conditions resulting from the 

September 11, 2001, terrorist attacks, at 

each site. The Administrator is required 

to consult with the WTC Health 

Program Scientific/Technical Advisory 

Committee (STAC) on the development 

of eligibility criteria related to such 

exposures. The PHS Act does not allow 

for enrollment of survivors from either 

of the two sites. 

C. Summary of WTC Health Program 

Findings: Evidence Concerning 

Eligibility Criteria for Pentagon and 

Shanksville, Pennsylvania Responders 

The Administrator reviewed relevant 

data to determine whether further 

eligibility criteria, beyond those criteria 

described in the Act for Pentagon and 

Shanksville responders (see Section 

III.B., above), was warranted. A report to 

the Administrator produced by NIOSH 

at the Administrator’s request reviewed 

published literature and other 

authoritative sources and consultations 

with participating responders from both 

sites, and served as the basis for the 

Administrator’s consideration.2 The 

Administrator assessed the reported 

results of environmental sampling at the 

respective sites as well as the estimated 

length of time that each of the various 

responder groups participated in rescue, 

recovery, demolition, debris cleanup, 

and other related response activities. 

The Administrator’s review of the 

evidence identified important response 

and cleanup events after the terrorist 

attacks and provided information on the 

exposures potentially experienced by 

the responders. The review also 

identified the sequence of events related 

to clean-up at the sites and identified 

the likely dates of termination of cleanup activities. 

Based on the evidence summarized 

below and after consultation with the 

STAC, the Administrator is revising the 

eligibility criterion to require that a 

Pentagon or Shanksville responder 

worked on-site for at least 1 day (the 

length of a standard work shift, or at 

least 4 hours but less than 24 hours) 

during the prescribed periods of time at 

either site. The Administrator is 

establishing dates for the end of cleanup activities at each site based on the 

best available evidence; they are 

November 19, 2001, for the Pentagon 

site and October 3, 2001, for the 

Shanksville, Pennsylvania site and 

seeks input on whether these dates are 

accurate. 

Pentagon Site 

According to the report to the 

Administrator, an estimated 60 Federal, 

State, and local agencies, including 

military personnel, responded to the 

Pentagon within the first 8 hours of the 

terrorist-related plane crash. Response 

activities included rescue efforts, site 

security, traffic control, and evidence 

collection. American Red Cross and 

Salvation Army personnel provided 

food and water, and civilian and 

military groups collaborated to address 

mental health issues. Emotional wellbeing support was provided by mental 

health professionals, clergy, 

physiotherapists, chiropractors, and 

therapy dogs and their handlers. 

Response activities occurred in many 

areas of the Pentagon Reservation, 

including but not limited to: the 

heliport; triage areas established on the 

Pentagon lawn near S. Washington Road 

and Jefferson Davis Highway and in the 

Pentagon Center Court; and the North 

Parking lot debris sifting area. Human 

remains were removed from the area of 

the crash site and driven to Fort Belvoir 

in Fairfax County, Virginia, where they 

were retrieved by Army helicopters and 


srobinson on DSK4SPTVN1PROD with RULES
18858 Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations 

3 Goldberg A, Papadopoulos S, Putney D, Berlage 

N, Welch R [2007]. Pentagon 9/11. Washington, DC: 

Historical Office, Office of the Secretary of Defense. 

http://osdhistory.defense.gov/history.html. 

4 Goldberg A, Papadopoulos S, Putney D, Berlage 

N, Welch R [2007]. Pentagon 9/11. Washington, DC: 

Historical Office, Office of the Secretary of Defense. 

http://osdhistory.defense.gov/history.html. 

Accessed March 4, 2013. 

5A Pentagon employee would not qualify as a 

responder unless he or she actively participated in 

rescue, recovery, demolition, debris cleanup, or 

other related response activities at the Pentagon 

site. 

6Our review of the response reports indicated 

that all environmental samples collected on floors 

1–5 of the Pentagon were below relevant health 

standards, except for lead (<10%) and asbestos 

(<5%) wipes. The majority of lead and asbestos 

wipes that exceeded the limit were collected on the 

fourth and fifth floors before cleanup activities. 

7Lash C [2001]. Flight 93 victim identification 

long, arduous. Pittsburg Post-Gazette, September 25. 

http://www.post-gazette.com/headlines/ 

20010925sledzik0925p3.asp. Accessed January 

2012. 

8ERM [2002]. Final Closure Report Flight 93, 

Shanksville, Pennsylvania. Environmental 

Resources Management. Prepared for United 

Airlines. 

9Transcript; Meeting Two of the World Trade 

Center Scientific/Technical Advisory Committee 

(STAC), Vol. I, Day One, February 15, 2012. The 

transcript is available in the STAC docket available 

at http://www.cdc.gov/niosh/docket/archive/ 

docket248.html. 

flown to Dover Air Force Base in 

Delaware.3

The Administrator found that the 

firefighter groups were on-site from 

September 11 to September 21, 2001, at 

which time control of the site was 

turned over to the Federal Bureau of 

Investigation (FBI). One fire company, a 

technical rescue team, paramedics, and 

some police departments were on-site 

until the Department of Defense 

assumed control from the FBI, which 

occurred no later than September 28, 

2001. Demolition and cleanup began on 

October 18 and concluded on November 

19, 2001. It is unclear what period of 

time fire and police department 

personnel were on-site during the 

period from the end of September until 

the end of cleanup activities on 

November 19, 2001, based on the 

available information. Recovery or 

cleanup contractors were on-site until 

November 19, 2001, which is when the 

demolition activities concluded.4

Finally, available evidence suggests that 

volunteers were likely on-site through 

September 28, 2001.5

Environmental sampling at the 

Pentagon site was conducted by U.S. 

Army, Navy, and Air Force personnel, 

as well as personnel from the former 

Walter Reed Army Medical Center, 

Department of Defense, the Uniformed 

Services University of the Health 

Sciences, and a civilian contractor. The 

Administrator’s review of the available 

literature found that contamination from 

the jet fuel, jet fuel combustion 

products, combustion products from 

aircraft and building materials, building 

debris, and human remains was 

concentrated at the incident site and 

most of the environmental samples 

collected were below occupational 

health and environmental exposure 

standards.6

After reviewing the length of time the 

various responder groups spent working 

at the Pentagon site, the Administrator 

has determined that, for the purposes of 

establishing eligibility criteria for 

Pentagon responders in 42 CFR 88.4(b), 

all rescue, recovery, demolition, debris 

cleanup, and other related response 

activities at the site concluded on 

November 19, 2001, which is when the 

demolition activities concluded. 

Shanksville, Pennsylvania Site 

The report to the Administrator 

determined that fire and police 

departments responded immediately to 

the plane crash at the Shanksville, 

Pennsylvania site and extinguished 

localized hot spots and brush fires. 

Because of the nature of the incident, 

there was only a limited fire response 

phase and no rescue response phase; 

responders proceeded to a recovery and 

investigatory response phase. 

Pennsylvania State Troopers provided 

security in and around the site, and the 

FBI assumed control over the site 

shortly after arriving on September 11. 

Personnel from the Somerset County 

(Pennsylvania) Coroner’s office, the 

Pennsylvania Region 13 CounterTerrorism Task Force, the State Funeral 

Directors Association, and other 

volunteers also joined the search for 

airplane parts and human remains. 

During the response, the American Red 

Cross and Salvation Army provided 

food and mental health services to 

responders. Response activities 

occurred on the property in Stonycreek 

Township, Somerset County, 

Pennsylvania, which is bounded by 

Route 30 (Lincoln Highway), State 

Route 1019 (Buckstown Road), and State 

Route 1007 (Lambertsville Road). 

Human remains were removed from the 

area of the crash site and taken to the 

Pennsylvania National Guard Armory in 

Friedens, Pennsylvania for 

identification.7

FBI controlled the crash site in 

Shanksville beginning on September 11 

and ending on September 24, 2001. At 

that time, control was relinquished to 

the Somerset County Coroner. The effort 

to search the area for remaining aircraft 

parts and human remains was 

conducted on September 29–30, 2001. 

After the response to the crash, 

Environmental Resources Management, 

Inc. (ERM) was contracted by United 

Airlines to document soil and water 

quality at the site. ERM compared the 

sampling results obtained to standards 

established by the Pennsylvania 

Department of Environmental Protection 

(PADEP) and the Pennsylvania Land 

Recycling and Environmental 

Remediation Standards Act. Although 

ERM concluded that no surface or 

subsurface soil samples exceeded any 

Pennsylvania standards and the site did 

not require any remediation, the 

Administrator has concluded that it is 

likely that responders to the Shanksville 

site were exposed to contamination 

from the jet fuel, jet fuel combustion 

products, combustion products from 

aircraft materials, and human remains.8

ERM’s reclamation activities took place 

between October 1 and October 3, 2001. 

It is not clear from available literature 

whether fire personnel or volunteers 

were on-site during these reclamation 

activities. Law enforcement personnel 

provided security on-site for a number 

of years following the events of 

September 11, 2001. 

After reviewing the length of time the 

various responder groups spent working 

at the Shanksville, Pennsylvania site, 

the Administrator has determined that, 

for the purposes of establishing 

eligibility criteria for Shanksville 

responders in 42 CFR 88.4(c), all rescue, 

recovery, demolition, debris cleanup, 

and other related response activities at 

the site concluded on October 3, 2001. 

STAC Review of Proposed Eligibility 

Criteria 

The report to the Administrator and 

the Administrator’s findings, including 

the response end-dates, were presented 

to the STAC during a public meeting 

held February 15–16, 2012. The STAC 

considered the proposed eligibility 

criteria and agreed that they are 

reasonable.9

IV. Issuance of an Interim Final Rule 

with Delayed Effective Date 

In most circumstances, the APA 

requires a public notice and comment 

period and consideration of the 

submitted comments prior to 

promulgation of a final rule having the 

effect of law. However, the APA 

provides for exceptions to its notice and 

comment procedures when an agency 

finds that there is good cause for 

dispensing with such procedures on the 

basis that they are impracticable, 

unnecessary, or contrary to the public 

interest. In the case of this interim final 

rule (IFR), HHS has determined that 

under 5 U.S.C. 553(b)(B), good cause 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations 18859 

exists for waiving the notice and 

comment procedures, and that the use 

of such procedures would be contrary to 

the public interest. This IFR amends 42 

CFR 88.4 to establish eligibility criteria 

for the enrollment of responders who 

responded to the September 11, 2001, 

terrorist attacks at the Pentagon and in 

Shanksville, Pennsylvania. HHS has 

determined that it is contrary to the 

public interest to delay any longer than 

necessary those individuals’ eligibility 

for treatment for WTC-related health 

conditions that are found to be related 

to the time they spent conducting 

rescue, recovery, demolition, debris 

cleanup, or other related services at 

either the Pentagon or Shanksville sites. 

Postponement in the implementation of 

eligibility criteria for Pentagon and 

Shanksville responders could result in 

real harm to those individuals who are 

currently coping with one or more 

health conditions found on the List of 

WTC-Related Health Conditions in 42 

CFR 88.1, or who are at risk for 

developing such a condition. Thus, HHS 

is waiving the prior notice and comment 

procedures in the interest of protecting 

the health of the Pentagon and 

Shanksville, Pennsylvania responders 

and allowing them to apply for 

enrollment in the WTC Health Program 

as soon as possible. 

Members of the affected communities 

have been given opportunities to meet 

with WTC Health Program staff to learn 

about the WTC Health Program and 

share thoughts and concerns. To date, 

WTC Health Program staff have traveled 

to both Arlington, Virginia and 

Shanksville, Pennsylvania to meet with 

responder representatives, including the 

Arlington, Virginia and Shanksville, 

Pennsylvania fire chiefs, and have also 

met with FBI responders. WTC Health 

Program staff have interviewed 

responders at both sites to collect 

exposure data and timelines of events. 

In addition, interested parties were 

given the opportunity to provide 

comment to the STAC on the proposed 

eligibility criteria for the Pentagon and 

Shanksville responders during the 

February 15–16, 2012, meeting of the 

STAC (no comments were received). 

The effective date of this interim final 

rule will be 31 days after publication in 

order to allow for any substantive 

feedback on the rule text. While 

amendments to § 88.4 will be effective 

31 days after the date of publication of 

this IFR, they are interim and will be 

finalized following the receipt of any 

substantive public comments. (See 

Section II. Public Participation, above.) 

V. Summary of Interim Final Rule 

This interim final rule will establish 

eligibility criteria for the enrollment of 

responders to the September 11, 2001, 

terrorist attacks at the Pentagon and in 

Shanksville, Pennsylvania. 

The eligibility criteria in § 88.4(b) and 

(c) apply to those individuals who were 

a member of a fire or police department 

(whether fire or emergency personnel, 

active or retired), worked for a recovery 

or cleanup contractor, or were 

volunteers; and performed rescue, 

recovery, demolition, debris cleanup, or 

other related services at either site. 

This interim final rule adds the 

definition of ‘‘police department’’ to the 

list of definitions in 42 CFR 88.1. 

Section 3311(a)(2)(C) of the PHS Act 

identifies eligible individuals who were 

a ‘‘member of a * * * police 

department.’’ The definition of ‘‘police 

department’’ promulgated in this 

interim final rule includes members of 

Federal, State, and local police 

departments and law enforcement 

agencies who were present on-site at the 

Pentagon or in Shanksville, 

Pennsylvania. 

This rule also adds definitions of 

‘‘Pentagon site’’ and ‘‘Shanksville, 

Pennsylvania site’’ to § 88.1. Based on 

the review of available evidence 

discussed above in section III.C., the 

definition ‘‘Pentagon site’’ includes the 

statutory definition of Pentagon 

Reservation found in 10 U.S.C. 

2674(f)(1): any area of the land 

(consisting of approximately 280 acres) 

and improvements thereon, located in 

Arlington, Virginia, on which the 

Pentagon Office Building, Federal 

Building Number 2, the Pentagon 

heating and sewage treatment plants, 

and other related facilities are located, 

including various areas designated for 

the parking of vehicles, affected by the 

terrorist-related aircraft crash on 

September 11, 2001. The Administrator 

believes that the specific locations 

where response activities occurred near 

the Pentagon were contained within the 

Pentagon Reservation, although the 

Administrator is seeking comment on 

boundaries of the Pentagon Reservation 

and the specific locations where 

response activities occurred. The 

Administrator has determined that the 

definition should also include those 

areas at Fort Belvoir in Virginia and at 

the Dover Port Mortuary at Dover Air 

Force Base in Delaware involved in the 

recovery, identification, and 

transportation of human remains from 

the terrorist attacks. The mortuary at 

Dover and areas of Fort Belvoir are 

included in the definition of ‘‘Pentagon 

site’’ in order to parallel the provision 

in the eligibility criteria for New York 

responders identifying responders 

(including morgue workers) who were 

involved in the examination and 

handling of human remains from the 

World Trade Center. 

After review of the evidence of events 

at the Shanksville, Pennsylvania site, 

the Administrator has defined 

‘‘Shanksville, Pennsylvania site’’ as the 

property in Stonycreek Township, 

Somerset County, Pennsylvania, which 

is bounded by Route 30 (Lincoln 

Highway), State Route 1019 (Buckstown 

Road), and State Route 1007 

(Lambertsville Road); the site also 

includes the Pennsylvania National 

Guard Armory in Friedens, 

Pennsylvania. Similar to the Pentagon 

site definition described above, the 

armory in Friedens is identified in order 

to establish parity with the eligibility 

criteria for the New York responders 

involved in the examination and 

handling of human remains. 

In order to establish that the 

individual is eligible for membership in 

the WTC Health Program, he or she 

must have participated in activities at 

either site for a minimum amount of 

time. Pentagon responders must have 

participated at the site for at least 1 day 

beginning September 11, 2001, and 

ending on November 19, 2001. 

Shanksville, Pennsylvania responders 

must have participated at that site for at 

least 1 day beginning September 11, 

2001, and ending on October 3, 2001. 

‘‘One day’’ is defined in 42 CFR 88.1 as 

‘‘the length of a standard work shift, or 

at least 4 hours but less than 24 hours.’’ 

The Administrator determined that 

presence at either site for at least 4 

hours is in keeping with the 

corresponding minimum amount of 

time required to establish eligibility for 

responders in the New York City area. 

(See, New York City responders 

eligibility criteria, 42 CFR 88.4(a).) The 

report to the Administrator (discussed 

in Section III.C., above) found that while 

area sampling was conducted at both 

sites in the aftermath of the terrorist 

attacks, personal exposure data is not 

available. The Administrator recognizes 

the potential for responders at the two 

sites to have been exposed to chemical, 

biological, and physical hazards, similar 

to some of the exposures experienced as 

a result of the September 11, 2001, 

terrorist attacks on the former World 

Trade Center site in New York City. 

VI. Applying for Coverage under this 

Interim Final Rule 

Upon promulgation of this interim 

final rule, individuals who were a 

member of a fire or police department 

(whether fire or emergency personnel, 


srobinson on DSK4SPTVN1PROD with RULES
18860 Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations 

10Please note that Section 3311(a)(5) of the PHS 

Act states that no individual who is determined to 

be a positive match to the terrorist watch list 

maintained by the Federal government shall qualify 

to become a WTC responder or screening-eligible or 

certified-eligible survivor. 

11WTC Health Program application for Pentagon 

and Shanksville responders will be available on the 

Program’s Web site at http://www.cdc.gov/wtc/ 

apply.html. 

12The List of WTC-Related Health Conditions can 

be found on the Program Web site at http:// 

www.cdc.gov/wtc/faq.html. 

13See § 3312(a)(1) of the PHS Act; 42 U.S.C. 

300mm–22(a)(1). 

active or retired), worked for a recovery 

or cleanup contractor, or who were 

volunteers; and performed rescue, 

recovery, demolition, debris cleanup, or 

other related services at either the 

Pentagon or Shanksville sites may apply 

to obtain coverage under the WTC 

Health Program. The application 

process for responders can be found in 

42 CFR 88.5. 

Beginning with the effective date of 

this rulemaking, an individual who 

believes that he or she meets the 

eligibility criteria established in this 

interim final rule and qualifies as a 

‘WTC responder (a ‘WTC responder’ is 

defined in § 88.1 as an individual who 

meets the specified eligibility criteria),10

must fill out and submit an application 

form to the WTC Health Program 

indicating that he or she meets certain 

eligibility criteria described in § 88.4.11

An individual who can demonstrate that 

he or she meets the eligibility criteria 

may be enrolled in the WTC Health 

Program. Supporting documentation is 

required to be submitted along with the 

application and if no documentation is 

included (e.g., a pay stub or personnel 

roster), the individual must explain how 

he or she attempted to find 

documentation and why the attempt 

was unsuccessful. The application must 

be signed by the applicant or a 

designated representative. An applicant 

who knowingly provides false 

information may be subject to a fine 

and/or imprisonment of not more than 

5 years. 

Once enrolled in the WTC Health 

Program, a WTC responder may receive 

treatment for specific physical and 

mental health conditions that have been 

certified by the WTC Health Program 

and are included on the List of WTCRelated Health Conditions.12 The List of 

WTC-Related Health Conditions was 

established by Congress and may be 

expanded by the Administrator through 

rulemaking; the List is included in 

§ 88.1, the definitions section of this 

rule. In order for an individual enrolled 

as a WTC responder to obtain coverage 

for treatment of any health condition on 

the List of WTC-Related Health 

Conditions, a two-step process must be 

satisfied. First, a physician at a Clinical 

Center of Excellence or in the 

nationwide provider network must 

make a determination that the particular 

health condition for which the 

responder seeks treatment coverage is 

both on the List of WTC-Related Health 

Conditions and that exposure to 

airborne toxins, other hazards, or 

adverse conditions resulting from the 

September 11, 2001, terrorist attacks is 

substantially likely to be a significant 

factor in aggravating, contributing to, or 

causing the health condition for which 

the responder seeks treatment 

coverage.13 Pursuant to 42 CFR 88.12(a), 

the physician’s determination must be 

based on the following: (1) an 

assessment of the individual’s exposure 

to airborne toxins, any other hazard, or 

any other adverse condition resulting 

from the September 11, 2001, attacks; 

and (2) the type of symptoms reported 

and the temporal sequence of those 

symptoms. As a second statutory 

requirement, all physician 

determinations are reviewed by the 

Administrator. The Administrator will 

certify the determination unless he or 

she determines that the responder’s 

condition is not on the List of WTCRelated Health Conditions or that 

exposure to airborne toxins, other 

hazards, or adverse conditions resulting 

from the September 11, 2001, terrorist 

attacks, is not substantially likely to be 

a significant factor in aggravating, 

contributing to, or causing the 

condition. 

VII. Regulatory Assessment 

Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). E.O. 13563 emphasizes the 

importance of quantifying both costs 

and benefits, of reducing costs, of 

harmonizing rules, and of promoting 

flexibility. 

This interim final rule has been 

determined to be a ‘‘significant’’ action, 

as defined in section 3(f)(1) of E.O. 

12866. Providing medical monitoring 

and treatment for Pentagon and 

Shanksville, Pennsylvania responders 

through the WTC Health Program will 

have an annual effect on the economy 

of less than $100 million. 

Summary 

The total cost, transfers, and benefits 

resulting from this regulatory action 

result from the expansion of the 

population of responders eligible to 

enroll in the WTC Health Program. In 

July, 2011, HHS published an interim 

final rule establishing the WTC Health 

Program regulations at 42 CFR Part 88 

(76 FR 38914, 38921, July 1, 2011). HHS 

estimated the costs and benefits 

associated with the development of the 

WTC Health Program and the 

subsequent enrollment, treatment, and 

monitoring of responders and survivors 

of the September 11, 2001, terrorist 

attacks on New York City. For the 

purpose of this analysis and as 

discussed below, HHS assumes that a 

percentage of enrolled responders will 

not have health insurance. Program 

costs associated with these uninsured 

responders are characterized as new 

‘‘societal costs’’ since these responders 

would not otherwise receive the health 

care available from the WTC Health 

Program. HHS further assumes that all 

of these previously uninsured 

responders will have access to health 

insurance after implementation of 

relevant provisions of the Patient 

Protection and Affordable Care Act 

(Affordable Care Act) (Pub. L. 111–148) 

in 2014. Accordingly, for the years 

2014–2016, all program costs, including 

program costs for these previously 

uninsured responders, are characterized 

as ‘‘transfers,’’ since all responders will 

have access to some type of health 

insurance under the Affordable Care Act 

beginning in 2014 and the impact of this 

regulation is only to ‘‘transfer’’ the cost 

from other such payers to the WTC 

Health Program. The costs and transfers 

identified in the July 2011 interim final 

rule include administrative expenses for 

enrollment and claims processing, the 

costs of medical monitoring, and 

medical treatment costs. To estimate the 

costs associated with enrollment and 

medical care of the Pentagon and 

Shanksville responders, HHS assumes 

that the program and administrative 

costs will be analogous to those costs for 

the New York City responders. HHS 

estimates the annual cost of medical 

monitoring and treatment to be 

provided and administrative expenses 

of this regulatory action in millions of 

dollars as presented in Table 1, below. 

The WTC Health Program has recently 

conducted rulemaking to add certain 

types of cancer to the List of WTCRelated Health Conditions in 42 CFR 

88.1 (77 FR 56138, September 12, 2012). 

The cost of treating and monitoring 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations 18861 

14 Goldberg A, Papadopoulos S, Putney D, Berlage 

N, Welch R [2007]. Pentagon 9/11. Washington, DC: 

Historical Office, Office of the Secretary of Defense. 

http://osdhistory.defense.gov/history.html. 

Accessed January 2012. 

The George Washington University, Institute for 

Crisis, Disaster, and Risk Management. The 

University of Pittsburgh. Observing and 

Documenting the Inter-Organizational Response to 

the September 11th Attack on the Pentagon: 

Activities and Findings. Research Supported by 

National Science Foundation Grant CMS–013909. 

Grant NK, Hoover DH, Scarisbrick-Hauser AM, 

Muffet SL [2003]. The Crash of United Flight 93 in 

Shanksville, Pennsylvania. In Natural Hazards 

Research and Applications Information Center, 

Public Entity Risk Institute, and Institute for Civil 

Infrastructure Systems, Beyond September 11th: An 

Account of Post-Disaster Research. Special 

Publication No. 39. Boulder, Colorado: Natural 

Hazards Research and Applications Information 

Center, University of Colorado. 

15U.S. Census Bureau [2011]. Current Population 

Survey. http://www.census.gov/hhes/www/ 

cpstables/032011/health/h05_000.xls. Accessed 

July 10, 2012. 

16The Urban Institute. Garrett B, Nichols L, and 

Greenman E [2001]. Workers Without Health 

Insurance: Who Are they and How Can Policy 

Reach Them? A Series of Community Voices 

Publications. 

cancers that may be certified for 

Pentagon and Shanksville responders is 

included in the analysis conducted in 

that rulemaking. 

TABLE 1—ANNUAL HEALTHCARE AND ADMINISTRATIVE COSTS AND TRANSFERS $MILLIONS (2011$) 

Societal Costs Transfers 

Discounted 7 

percent * 

Discounted 3 

percent 

Discounted 7 

percent 

Discounted 3 

percent 

Administrative 

Low Estimate ............................................................................................ $0.33 ........................ ........................ ........................

High Estimate ........................................................................................... ........................ $0.90 ........................ ........................

Medical Monitoring and Treatment 

Low Estimate ............................................................................................ $0.27 ........................ $0.73 ........................

High Estimate ........................................................................................... ........................ $0.80 ........................ $1.62 

Total 

Low Estimate ............................................................................................ $0.60 ........................ $0.73 ........................

High Estimate ........................................................................................... ........................ $1.70 ........................ $1.62 

* Discount rates are used to estimate the present value of health benefits occurring in the future. (See OMB Circulars A–4 and A–94 Revised.) 

Population Covered 

According to published studies, up to 

8,000 individuals responded to the 

terrorist attack at the Pentagon and 

approximately 1,000 responded in 

Shanksville, Pennsylvania.14 For the 

purposes of this economic analysis, 

HHS estimates the total population of 

potential new enrollees in the WTC 

Health Program from the Pentagon and 

Shanksville sites to be 9,000 responders. 

In order to estimate the number and rate 

of Pentagon and Shanksville responders 

who may apply for enrollment in the 

WTC Health Program, HHS assumed 

two enrollment scenarios based on the 

share of uninsured responders. First, 

HHS assumed that of the 9,000 eligible 

responders, 1,467 (16.3 percent, the 

current National average rate of 

uninsured persons) 15 will be uninsured 

and therefore will likely apply for 

enrollment as soon as eligibility criteria 

are promulgated. Alternatively, HHS 

assumed that of the 9,000 responders, 

540 (6 percent) will be uninsured. The 

6 percent uninsured rate is derived from 

a study by the Urban Institute, which 

indicates that 97 percent of workers in 

public administration are insured.16 For 

the purposes of this analysis, HHS 

further assumed that most public 

agencies (Federal, state, and local) 

involved in these responses similarly 

offer health insurance to employees, 

that retention rates for public sector 

employment tend to be high, and that 

disability insurance and health 

insurance among retired public 

employees are also likely to be high. To 

account for uncertainty regarding the 

impact on insurance rates of retention, 

disability, and retirements among public 

employee responders involved in these 

responses, as well as uncertainty 

regarding the quotient of volunteer 

responders who were not public 

employees, we doubled the uninsured 

rate of 3 percent documented in the 

Urban Institute study to 6 percent. HHS 

further assumed that 1.3 percent of the 

remaining unenrolled population will 

enroll on an annual basis thereafter. 

This percentage is based on the current 

rate at which individuals who 

responded to or survived the terrorist 

attacks in New York City are enrolling 

in the WTC Health Program. 

Cost Estimates 

Using data from the Program’s 

operational experience to date (since 

July 1, 2011), HHS has estimated costs 

for administrative activities and medical 

monitoring and treatment, and has 

estimated related rates of enrollment 

and certification of individuals who 

responded at the Pentagon or in 

Shanksville. The analyses of WTC 

Health Program costs use a low estimate 

reflecting actual costs associated with 

maintaining the existing program plus 

additional administrative activities, and 

a higher estimate level that assumes 

increases in both administrative costs 

and other health care costs. 

As discussed above, the WTC Health 

Program expects to initially enroll a 

minimum of 540 and a maximum of 

1,467 Pentagon and Shanksville, 

Pennsylvania responders in 2013 and 

between 97 and 110 additional new 

enrollees over the course of the first 

year. HHS assumes that there will be 

between 97 and 109 new enrollees in 

2014, between 95 and 107 in 2015, and 

between 94 and 106 in 2016. 

• Administrative Costs 

HHS estimates administrative costs 

ranging between $326,519 and $900,565 

annually, covering program 

management, enrollment of Pentagon 

and Shanksville responders, 

certification of WTC-related health 

conditions, authorization of medical 

care, payment services, administration 

of appeals processes, and education and 

outreach. The range of the costs 

estimated reflects uncertainty associated 

with levels of activity for enrollment, 

appeals, and competitively established 

costs for contractual administrative 

services. All administrative costs are 

counted as societal costs. 

• Costs of Medical Monitoring 

New enrollees are eligible for an 

initial medical examination. The costs 

per patient are estimated between $650 

and $1,032 per individual. The low 

estimate is based on the average costs 


srobinson on DSK4SPTVN1PROD with RULES
18862 Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations 

17The nationwide provider network is the system 

of healthcare providers that provides medical 

monitoring and treatment to WTC Health Program 

responders and survivors who live outside of the 

New York City area. Although a Pentagon responder 

enrolled in the WTC Health Program may be 

evaluated, diagnosed, and/or treated at a Clinical 

Center of Excellence (New York-based, WTC Health 

Program providers), this analysis presumes that all 

enrollees will visit local providers in the 

nationwide network. 

18Section 3312(c)(1)(A) of the PHS Act requires 

the Administrator to base treatment costs on the 

relevant Federal Employees Compensation Act 

rates. See 5 U.S.C. 8101 et seq., 20 CFR part 20. 

for patients currently enrolled in the 

WTC Health Program serviced by the 

nationwide provider network.17 The 

high estimate is based on the services if 

all tests were conducted and billed at 

the Federal Employees Compensation 

Act (FECA) rates for Washington, DC.18

These projections assume 35 percent 

of enrolled responders will obtain 

annual monitoring examinations, which 

is the average participation rate for WTC 

responders in the current Program. The 

monitoring exams are provided only in 

the years following the initial medical 

exam. All monitoring costs incurred in 

2013 are counted as societal costs 

because the population basis assumed 

that the initial influx of new enrollees 

will be uninsured, and that an 

additional 97 to 110 new responders 

will be added over the course of the 

year. All medical costs incurred in 2014 

through 2016 are counted as transfers. 

• Costs of Medical Treatment 

The estimated costs for medical 

treatment are based on an average cost 

in the WTC Health Program. HHS 

estimates the cost of treatment to be 

$3,500 per patient. The estimate is 

based on the average costs for patients 

currently enrolled in the WTC Health 

Program serviced by the nationwide 

provider network. HHS has no 

quantitative basis to estimate a different 

rate of medical treatment utilization for 

this population as compared to the New 

York City WTC responders. Therefore, 

as was done in the July 2011 economic 

analysis, HHS assumes that 29 percent 

of future enrolled WTC responders will 

receive treatment annually. The range of 

average per patient costs is based on the 

average costs for patients having 

received treatment through the WTC 

Health Program. HHS assumes that in 

2013 the initial influx of Pentagon and 

Shanksville enrollees who receive 

medical treatment in the WTC Health 

Program will not have medical 

insurance provided by employer, 

private sources, Medicare, or Medicaid; 

thereafter, HHS assumes that an 

additional 97 to 110 responders would 

enroll throughout the year. HHS 

assumes that all of the enrollees who 

receive medical treatment will have 

access to medical insurance in 2014 and 

beyond when the provisions of the 

Affordable Care Act are implemented. 

Therefore, all treatment costs occurring 

in 2014 and beyond are counted as 

transfers. 

A summary of annual WTC Health 

Program costs associated with this 

rulemaking is presented in Table 2 

below. 

TABLE 2—SUMMARY OF MEDICAL MONITORING AND TREATMENT (IN $2011) 

Pentagon & Shanksville Responders 2013 2014 2015 2016 

Total Number of WTC Health Program Enrollees 

Low ........................................................................................................... 650 759 866 971 

High .......................................................................................................... 1,565 1,662 1,757 1,851 

Initial Medical Examination 

New Enrollees 

Low ........................................................................................................... 650 109 107 106 

High .......................................................................................................... 1,565 97 95 94 

Total Undiscounted Cost of Initial Health Evaluation 

Low Estimate=$650 per person ............................................................... $422,500 $70,600 $69,600 $68,700 

High Estimate = $1,032 per person ......................................................... 1,615,000 99,700 98,500 97,200 

Annual Medical Monitoring 

35% of All Enrollees, (1-year lag) 

Low ........................................................................................................... ........................ 227 265 303 

High .......................................................................................................... ........................ 548 582 615 

Total Undiscounted Cost of Annual Evaluation 

Low Estimate = $650 per person ............................................................. ........................ 147,900 172,600 196,900 

High Estimate = $1,032 per person ......................................................... ........................ 565,300 600,200 634,600 

Medical Treatment 

29% of All Enrollees 

Low ........................................................................................................... 188 220 251 282 

High .......................................................................................................... 454 482 510 537 

Total Undiscounted Cost of Medical Treatment 

Low Estimate ............................................................................................ 659,700 769,900 878,700 986,000 

High Estimate ........................................................................................... 1,588,400 1,686,500 1,783,300 1,878,900 

Initial Medical Examination, Monitoring, and Treatment Total 

Low Estimate ............................................................................................ 1,082,200 988,300 1,120,900 1,251,700 

High Estimate ........................................................................................... 3,203,400 2,351,500 2,482,000 2,610,700 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations 18863 

Benefits 

Although we cannot quantify the 

benefits associated with the WTC Health 

Program, enrollees with a WTC-related 

health condition are expected to 

experience a higher quality of care than 

they would in the absence of the 

Program. Mortality and morbidity 

improvements for patients expected to 

enroll in the WTC Health Program are 

anticipated because barriers may exist to 

access and delivery of quality health 

care services in the absence of the 

services provided by the WTC Health 

Program. HHS anticipates benefits to 

patients treated through the WTC Health 

Program, who may otherwise not have 

access to health care services, to accrue 

in 2013. Starting in 2014, continued 

implementation of the Affordable Care 

Act will result in increased access to 

health insurance and improved health 

care services for the general responder 

and survivor population that currently 

is uninsured. 

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. HHS believes that 

this rule has ‘‘no significant economic 

impact upon a substantial number of 

small entities’’ within the meaning of 

the RFA. 

Because no small businesses are 

impacted by this rulemaking, HHS 

certifies that this rule will not have a 

significant economic impact on a 

substantial number of small entities 

within the meaning of the RFA. 

Therefore, a regulatory flexibility 

analysis as provided for under RFA is 

not required. 

C. Paperwork Reduction Act 

Under the Paperwork Reduction Act 

of 1995 (44 U.S.C. 3501 et seq.), a 

Federal agency shall not conduct or 

sponsor a collection of information from 

10 or more persons other than Federal 

employees unless the Director of the 

Office of Management and Budget 

(OMB) has approved the proposed 

collection of information. A person is 

not required to respond to a collection 

of information unless it displays a 

currently valid OMB control number. 

HHS has determined that this interim 

final rule contains information 

collection and record keeping 

requirements that are subject to review 

by OMB. This interim final rule will 

result in additional responses and 

burden hours associated with an 

existing information collection (World 

Trade Center Health Program 

Enrollment, Appeals & Reimbursement, 

OMB Control Number 0920–0891, 

current expiration date 12/31/2014). In 

order to account for those increases in 

responses and burden without delay, 

HHS is requesting emergency review 

and clearance for a new information 

collection specifically for Pentagon and 

Shanksville responders. A description 

of the relevant regulatory provisions is 

given below with an estimate of the 

annual reporting burden. Included in 

the estimate of the annual reporting 

burden is the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing each collection of 

information. In compliance with the 

requirement of section 3506(c)(2)(A) of 

the PRA for opportunity for public 

comment on proposed data collection 

projects, CDC will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, you may call 404–639– 

5960; send comments to Kimberly S. 

Lane, 1600 Clifton Road, MS–D74, 

Atlanta, GA 30333; or send an email to 

omb@cdc.gov. 

Comments are invited on the 

following: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the Agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

Agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents. Written comments 

should be received within 30 days of the 

publication of this notice. 

Proposed Project: World Trade Center 

Health Program Enrollment, Appeals & 

Reimbursement for Pentagon and 

Shanksville Responders—New— 

National Institute for Occupational 

Safety and Health, Centers for Disease 

Control and Prevention. 

Background and Brief Description: 

Title XXXIII of the PHS Act as amended 

establishes the WTC Health Program 

within HHS. The Program provides 

medical monitoring and treatment 

benefits to responders to the September 

11, 2001, terrorist attacks in New York 

City, at the Pentagon, and in 

Shanksville, Pennsylvania, and to 

survivors of the terrorist attacks in New 

York City. Title XXXIII requires that 

various Program provisions be 

established by regulation, including 

eligibility criteria for responders at the 

Pentagon and in Shanksville, 

Pennsylvania. 

This interim final rule revises the data 

collection requirements that have been 

approved by OMB under OMB Control 

Number 0920–0891, with an expiration 

date of 12/31/2014. The addition of 

eligible respondents resulting from this 

interim final rule will increase the 

number of respondents and burden 

associated with the following provisions 

of 42 CFR part 88: 

Section 88.5 Application process— 

status as a WTC responder. This section 

informs applicants (1,605 respondents) 

who believe they meet the eligibility 

criteria for a WTC responder how to 

apply for enrollment in the WTC Health 

Program and describes the types of 

documentation the WTC Program 

Administrator will accept as proof of 

eligibility. We estimate that the 

application process will take an average 

of 30 minutes. 

Section 88.11 Appeals regarding 

eligibility determination—responders 

and survivors. This section establishes 

the process for appeals regarding 

eligibility determinations. Of those 

Pentagon and Shanksville responders 

expected to apply for enrollment in the 

Program (1,605), HHS expects that 2.5 

percent (40) will fail due to ineligibility. 

HHS further assumes that 10 percent of 

those individuals (4 respondents) will 

appeal the decision. We estimate that 

the appeals letter will take no more than 

30 minutes. 

Section 88.15 Appeals regarding 

treatment. This section establishes the 

timeline and process to appeal the 

Administrator’s determinations 

regarding treatment decisions. HHS 

estimates that Program participants will 

request certification for 874 health 

conditions each year. Of those 874, we 

expect that 1 percent (<1) will be denied 

certification by the WTC Program 

Administrator. We further expect that 

such a denial will be appealed 95 

percent of the time. Of the projected 454 

enrollees who will receive medical care, 

based on current Program data it is 

estimated that 3 percent (14) will appeal 

decisions of unnecessary treatment. We 

estimate that the appeals letter will take 

no more than 30 minutes. 

Section 88.16 Reimbursement for 

medically necessary treatment, 

outpatient prescription 

pharmaceuticals, monitoring, initial 

health evaluations, and travel expenses. 

This section establishes the process by 

which a member of the Clinical Centers 

of Excellence or the nationwide 

provider network will be reimbursed by 

the WTC Health Program for the cost of 


srobinson on DSK4SPTVN1PROD with RULES
18864 Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations 

medical treatment and outpatient 

prescription pharmaceuticals, and a 

WTC responder may be reimbursed for 

certain transportation expenses. 

Standard U.S. Treasury form SF 3881 

(OMB No. 1510–0056) will be used to 

gather necessary information from 

Program healthcare providers so that 

they can be reimbursed directly from 

the Treasury Department. HHS expects 

that approximately 5 providers and 

provider groups will submit SF 3881, 

which is estimated to take 15 minutes 

to complete. Providers will submit only 

one SF 3881. 

Pharmacies will electronically 

transmit reimbursement claims to the 

WTC Health Program. HHS estimates 

that 4 pharmacies will submit 

reimbursement claims for 1,058 

prescriptions per year, or 265 per 

pharmacy; we estimate that each 

submission will take 1 minute. 

WTC responders who travel more 

than 250 miles to a nationwide network 

provider for medically necessary 

treatment may be provided necessary 

and reasonable transportation and other 

expenses. These individuals may submit 

a travel refund request form, which 

should take respondents 10 minutes to 

complete. HHS expects no more than 1 

claim per year. 

The reporting and record keeping 

requirements contained in these 

regulations are used by NIOSH to carry 

out its responsibilities related to the 

implementation of the WTC Health 

Program as required by law. The 

burdens imposed have been reduced to 

the absolute minimum considered 

necessary to permit NIOSH to carry out 

the purpose of the legislation, i.e., to 

implement the WTC Health Program. 

This emergency data collection is 

warranted because it is essential that 

individuals who wish to be enrolled, 

apply to the WTC Health Program, 

appeal a determination made by the 

WTC Program Administrator, or submit 

a claim for reimbursement have the 

opportunity to do so as soon as the 

eligibility criteria are established upon 

the effective date of this interim final 

rule. 

This new information collection 

request is for 832.5 annual burden 

hours. 

Section Title Number of 

respondents 

Responses 

per 

respondent 

Average 

burden per 

response (min) 

Total burden 

(hr) 

88.5 ............... Application process—status as a WTC responder (Pentagon and Shanksville).1,605 1 30/60 803 

88.11 ............. Appeals regarding eligibility determinations ...................... 4 1 30/60 2 

88.15 ............. Appeals regarding treatment ............................................. 14 1 30/60 7 

88.15 ............. Appeals regarding certification of health conditions .......... 1 1 30/60 .5 

88.16 ............. Reimbursement for: ...........................................................

Medically necessary treatment, monitoring, initial health 

evaluations.

5 1 15/60 * 1 .5 

Outpatient prescription pharmaceuticals ........................... 4 265 1/60 18 

Travel expenses ................................................................. 1 1 10/60 * .5 

Total ....... ............................................................................................ ........................ ........................ ........................ 832 .5 

* These values are rounded up to the nearest half-hour. 

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.), the Department 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 rule does not 

include any Federal mandate that may 

result in increased annual expenditures 

in excess of $100 million by State, local 

or tribal governments in the aggregate, 

or by the private sector. For 2012, the 

inflation adjusted threshold is $139 

million. 

F. Executive Order 12988 (Civil Justice) 

This 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 Department has reviewed this 

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, HHS has evaluated the 

environmental health and safety effects 

of this rule on children. HHS 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, HHS has evaluated the effects of 

this rule on energy supply, distribution 

or use, and has determined that the rule 

will not have a significant adverse 

effect. 

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. HHS has 

attempted to use plain language in 

promulgating the proposed rule 

consistent with the Federal Plain 

Writing Act guidelines. 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations 18865 

List of Subjects in 42 CFR Part 88 

Aerodigestive disorders, Appeal 

procedures, Health care, Mental health 

conditions, Musculoskeletal disorders, 

Respiratory and pulmonary diseases. 

Text of the 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. 

■ 2. Amend § 88.1 by adding the 

definitions of ‘‘Pentagon site,’’ ‘‘police 

department,’’ and ‘‘Shanksville, 

Pennsylvania site,’’ in alphabetical 

order, to read as follows: 

§ 88.1 Definitions. 

* * * * * 

Pentagon site means any area of the 

land (consisting of approximately 280 

acres) and improvements thereon, 

located in Arlington, Virginia, on which 

the Pentagon Office Building, Federal 

Building Number 2, the Pentagon 

heating and sewage treatment plants, 

and other related facilities are located, 

including various areas designated for 

the parking of vehicles, vehicle access, 

and other areas immediately adjacent to 

the land or improvements previously 

described that were affected by the 

terrorist-related aircraft crash on 

September 11, 2001; and those areas at 

Fort Belvoir in Fairfax County, Virginia 

and at the Dover Port Mortuary at Dover 

Air Force Base in Delaware involved in 

the recovery, identification, and 

transportation of human remains for the 

incident. 

Police department means any law 

enforcement department or agency, 

whether under Federal, state, or local 

jurisdiction, responsible for general 

police duties, such as maintenance of 

public order, safety, or health, 

enforcement of laws, or otherwise 

charged with prevention, detection, 

investigation, or prosecution of crimes. 

* * * * * 

Shanksville, Pennsylvania site means 

the property in Stonycreek Township, 

Somerset County, Pennsylvania, which 

is bounded by Route 30 (Lincoln 

Highway), State Route 1019 (Buckstown 

Road), and State Route 1007 

(Lambertsville Road); and those areas at 

the Pennsylvania National Guard 

Armory in Friedens, Pennsylvania 

involved in the recovery, identification, 

and transportation of human remains for 

the incident. 

■ 3. Amend § 88.4 by adding paragraphs 

(b) and (c) to read as follows: 

§ 88.4 Eligibility criteria—status as a WTC 

responder. 

* * * * * 

(b) Responders to the Pentagon site of 

the September 11, 2001, terrorist 

attacks, may apply for enrollment in the 

WTC Health Program on or after April 

29, 2013. Individuals must meet the 

criteria below to be considered eligible 

for enrollment: 

(1) The individual was an active or 

retired member of a fire or police 

department (fire or emergency 

personnel), worked for a recovery or 

cleanup contractor, or was a volunteer; 

and 

(2) Performed rescue, recovery, 

demolition, debris cleanup, or other 

related services at the Pentagon site of 

the September 11, 2001, terrorist 

attacks, for at least 1 day beginning 

September 11, 2001, and ending on 

November 19, 2001. 

(c) Responders to the Shanksville, 

Pennsylvania site of the September 11, 

2001, terrorist attacks, may apply for 

enrollment in the WTC Health Program 

on or after April 29, 2013. Individuals 

must meet the criteria below to be 

considered eligible for enrollment: 

(1) The individual was an active or 

retired member of a fire or police 

department (fire or emergency 

personnel), worked for a recovery or 

cleanup contractor, or was a volunteer; 

and 

(2) Performed rescue, recovery, 

demolition, debris cleanup, or other 

related services at the Shanksville, 

Pennsylvania site of the September 11, 

2001, terrorist attacks, for at least 1 day 

beginning September 11, 2001, and 

ending on October 3, 2001. 

* * * * * 

Dated: October 2, 2012. 

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. 2013–07146 Filed 3–27–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF DEFENSE 

Defense Acquisition Regulations 

System 

48 CFR Parts 215 and 252 

RIN 0750–AH47 

Defense Federal Acquisition 

Regulation Supplement: Proposal 

Adequacy Checklist (DFARS Case 

2011–D042) 

AGENCY: Defense Acquisition 

Regulations System, Department of 

Defense (DoD). 

ACTION: Final rule. 

SUMMARY: DoD is issuing a final rule 

amending the Defense Federal 

Acquisition Regulation Supplement 

(DFARS) to incorporate a proposal 

adequacy checklist for proposals in 

response to solicitations that require 

submission of certified cost or pricing 

data. 

DATES: Effective Date: March 28, 2013 

FOR FURTHER INFORMATION CONTACT: Mr. 

Dustin Pitsch, telephone 571–372–6090. 

SUPPLEMENTARY INFORMATION: 

I. Background 

DoD published a proposed rule in the 

Federal Register at 76 FR 75512 on 

December 2, 2011, to incorporate the 

requirement for a proposal adequacy 

checklist into DFARS 215.408, and an 

associated solicitation provision at 

252.215–7009, to ensure offerors take 

responsibility for submitting thorough, 

accurate, and complete proposals. 

Fifteen respondents submitted public 

comments in response to the proposed 

rule. 

II. Discussion and Analysis of the 

Public Comments 

DoD reviewed the public comments in 

the development of the final rule. A 

discussion of the comments and the 

changes made to the rule as a result of 

those comments is provided, as follows: 

A. Summary of significant changes 

from the proposed rule. 

• The sentence ‘‘Completion of this 

checklist in no way reduces the 

responsibility to fully comply with all of 

the requirements of 41 U.S.C. chapter 

35, Truthful Cost or Pricing Data, and 

any other special requirements of the 

solicitation.’’ is removed from the 

checklist instructions at DFARS 

252.215–7009. 

• The sentence ‘‘In preparation of the 

offeror’s checklist, offerors may elect to 

have their prospective subcontractors 

use the same or similar checklist as 

appropriate.’’ was added to the end of 


srobinson on DSK4SPTVN1PROD with RULES