[Federal Register Volume 78, Number 60 (Thursday, March 28, 2013)]
[Rules and Regulations]
[Pages 18855-18865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07146]


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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.

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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 e-rulemaking 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://

[[Page 18856]]

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: [email protected].

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 Sec.  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

[[Page 18857]]

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.
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    \1\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm 
to 300mm-61. Those portions of the Zadroga Act found in Titles II 
and III of Public Law 111-347 do not pertain to the WTC Health 
Program and are codified elsewhere.
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    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 Sec.  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 clean-up activities.
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    \2\ McCleery 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.
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    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 clean-up 
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 
well-being 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

[[Page 18858]]

flown to Dover Air Force Base in Delaware.\3\
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    \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.
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    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\
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    \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.
    \5\ A 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.
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    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\
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    \6\ Our 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.
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    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 Counter-Terrorism 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\
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    \7\ Lash C [2001]. Flight 93 victim identification long, 
arduous. Pittsburg Post-Gazette, September 25. http://www.post-gazette.com/headlines/20010925sledzik0925p3.asp. Accessed January 
2012.
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    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.
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    \8\ ERM [2002]. Final Closure Report Flight 93, Shanksville, 
Pennsylvania. Environmental Resources Management. Prepared for 
United Airlines.
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    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\
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    \9\ Transcript; 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.
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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

[[Page 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 Sec.  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 Sec.  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 Sec.  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,

[[Page 18860]]

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 Sec.  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 Sec.  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.
---------------------------------------------------------------------------

    \10\ Please 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.
    \11\ WTC 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.
---------------------------------------------------------------------------

    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 WTC-Related 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 Sec.  
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 WTC-Related 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.
---------------------------------------------------------------------------

    \12\ The List of WTC-Related Health Conditions can be found on 
the Program Web site at http://www.cdc.gov/wtc/faq.html.
    \13\ See Sec.  3312(a)(1) of the PHS Act; 42 U.S.C. 300mm-
22(a)(1).
---------------------------------------------------------------------------

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 WTC-Related Health Conditions in 
42 CFR 88.1 (77 FR 56138, September 12, 2012). The cost of treating and 
monitoring

[[Page 18861]]

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    Discounted 3    Discounted 7    Discounted 3
                                                     percent *        percent         percent         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.
---------------------------------------------------------------------------

    \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.
    \15\ U.S. Census Bureau [2011]. Current Population Survey. 
http://www.census.gov/hhes/www/cpstables/032011/health/h05_000.xls. 
Accessed July 10, 2012.
    \16\ The 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.
---------------------------------------------------------------------------

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

[[Page 18862]]

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\
---------------------------------------------------------------------------

    \17\ The 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.
    \18\ Section 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.
---------------------------------------------------------------------------

    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
----------------------------------------------------------------------------------------------------------------


[[Page 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-for-profit 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 
[email protected].
    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

[[Page 18864]]

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.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                         Average burden
                    Section                                       Title                     Number of     Responses per   per response     Total burden
                                                                                           respondents     respondent         (min)            (hr)
--------------------------------------------------------------------------------------------------------------------------------------------------------
88.5...........................................  Application process--status as a WTC             1,605               1           30/60            803
                                                  responder (Pentagon and Shanksville).
88.11..........................................  Appeals regarding eligibility                        4               1           30/60              2
                                                  determinations.
88.15..........................................  Appeals regarding treatment...........              14               1           30/60              7
88.15..........................................  Appeals regarding certification of                   1               1           30/60               .5
                                                  health conditions.
88.16..........................................  Reimbursement for:....................               5               1           15/60            * 1.5
                                                 Medically necessary treatment,
                                                  monitoring, initial health
                                                  evaluations.
                                                                                                                                        ----------------
                                                 Outpatient prescription                              4             265            1/60             18
                                                  pharmaceuticals.
                                                 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.

[[Page 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

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

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

0
2. Amend Sec.  88.1 by adding the definitions of ``Pentagon site,'' 
``police department,'' and ``Shanksville, Pennsylvania site,'' in 
alphabetical order, to read as follows:


Sec.  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.

0
3. Amend Sec.  88.4 by adding paragraphs (b) and (c) to read as 
follows:


Sec.  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