Interim Final Rule

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

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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
Centers for Disease Control and
Prevention, HHS.
ACTION: Interim final rule with request
for comments.
AGENCY:

SUMMARY: Title I of the James Zadroga
9/11 Health and Compensation Act of

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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://

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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

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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,

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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

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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

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

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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
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.
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.

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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
This document is available in the docket for this
rulemaking.

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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
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.
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.
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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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
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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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
8 ERM [2002]. Final Closure Report Flight 93,
Shanksville, Pennsylvania. Environmental
Resources Management. Prepared for United
Airlines.
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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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.)

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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

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18859

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,

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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
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.
12 The List of WTC-Related Health Conditions can
be found on the Program Web site at http://
www.cdc.gov/wtc/faq.html.

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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
13 See § 3312(a)(1) of the PHS Act; 42 U.S.C.
300mm–22(a)(1).

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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

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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

Administrative
Low Estimate ............................................................................................
High Estimate ...........................................................................................
Medical Monitoring and Treatment
Low Estimate ............................................................................................
High Estimate ...........................................................................................

Transfers

Discounted 7
percent *

Discounted 3
percent

Discounted 7
percent

Discounted 3
percent

$0.33
........................

........................
$0.90

........................
........................

........................
........................

$0.27
........................

........................
$0.80

$0.73
........................

........................
$1.62

$0.60
........................

........................
$1.70

$0.73
........................

........................
$1.62

Total
Low Estimate ............................................................................................
High Estimate ...........................................................................................

* 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.)

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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
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.

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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
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.

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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

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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

Total Number of WTC Health Program Enrollees
Low ...........................................................................................................
High ..........................................................................................................

2014

2015

2016

650
1,565

759
1,662

866
1,757

971
1,851

650
1,565

109
97

107
95

106
94

$422,500
1,615,000

$70,600
99,700

$69,600
98,500

$68,700
97,200

........................
........................

227
548

265
582

303
615

........................
........................

147,900
565,300

172,600
600,200

196,900
634,600

188
454

220
482

251
510

282
537

659,700
1,588,400

769,900
1,686,500

878,700
1,783,300

986,000
1,878,900

1,120,900
2,482,000

1,251,700
2,610,700

Initial Medical Examination
New Enrollees
Low ...........................................................................................................
High ..........................................................................................................
Total Undiscounted Cost of Initial Health Evaluation
Low Estimate=$650 per person ...............................................................
High Estimate = $1,032 per person .........................................................

Annual Medical Monitoring
35% of All Enrollees, (1-year lag)
Low ...........................................................................................................
High ..........................................................................................................
Total Undiscounted Cost of Annual Evaluation
Low Estimate = $650 per person .............................................................
High Estimate = $1,032 per person .........................................................

Medical Treatment
29% of All Enrollees
Low ...........................................................................................................
High ..........................................................................................................
Total Undiscounted Cost of Medical Treatment
Low Estimate ............................................................................................
High Estimate ...........................................................................................

Initial Medical Examination, Monitoring, and Treatment Total

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Low Estimate ............................................................................................
High Estimate ...........................................................................................

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

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1,082,200
3,203,400

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.

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988,300
2,351,500

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.

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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.

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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

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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

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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

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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

Responses
per
respondent

Average
burden per
response (min)

Total burden
(hr)

1

30/60

803

4
14
1
5

1
1
1
1

30/60
30/60
30/60
15/60

2
7
.5
* 1.5

Outpatient prescription pharmaceuticals ...........................
Travel expenses .................................................................

4
1

265
1

1/60
10/60

18
*.5

............................................................................................

........................

........................

........................

832.5

Number of
respondents

Section

Title

88.5 ...............

Application process—status as a WTC responder (Pentagon and Shanksville).
Appeals regarding eligibility determinations ......................
Appeals regarding treatment .............................................
Appeals regarding certification of health conditions ..........
Reimbursement for: ...........................................................
Medically necessary treatment, monitoring, initial health
evaluations.

1,605

88.11
88.15
88.15
88.16

.............
.............
.............
.............

Total .......

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.

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

F. Executive Order 12988 (Civil Justice)

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.

G. Executive Order 13132 (Federalism)

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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.

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17:43 Mar 27, 2013

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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.
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

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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.

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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

§ 88.4 Eligibility criteria—status as a WTC
responder.

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.

*

srobinson on DSK4SPTVN1PROD with RULES

and transportation of human remains for
the incident.

*
*
*
*
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,

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

*

*
*
*
*
(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

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18865

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)
Defense Acquisition
Regulations System, Department of
Defense (DoD).
ACTION: Final rule.
AGENCY:

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.

Effective Date: March 28, 2013
Mr.
Dustin Pitsch, telephone 571–372–6090.
SUPPLEMENTARY INFORMATION:
DATES:

FOR FURTHER INFORMATION CONTACT:

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

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