[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Rules and Regulations]
[Pages 24628-24632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-9425]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. CDC-2011-0010]
42 CFR Part 88
RIN 0920-AA45
World Trade Center Health Program Requirements for the Addition
of New WTC-Related Health Conditions
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Final rule.
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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) to establish
the World Trade Center (WTC) Health Program. Sections 3311, 3312, and
3321 of Title XXXIII of the PHS Act require that the WTC Program
Administrator develop regulations to implement portions of the WTC
Health Program established within the Department of Health and Human
Services (HHS). The WTC Health Program, which is administered by the
Director of the National Institute for Occupational Safety and Health
(NIOSH), within the Centers for Disease Control and Prevention (CDC),
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, PA, and at the Pentagon, and to
eligible survivors of the New York City attacks. This final rule
establishes the processes by which the WTC Program Administrator may
add a new condition to the list of WTC-related health conditions
through rulemaking, including a process for considering petitions by
interested parties to add a new condition.
DATES: This final rule is effective May 25, 2012.
FOR FURTHER INFORMATION CONTACT: Roy M. Fleming, Sc.D., Senior Science
Advisor, World Trade Center Health Program, Office of the Director,
National Institute for Occupational Safety and Health, 1600 Clifton
Road NE., MS-E74, Atlanta, GA 30329; telephone 866-426-3673 (this is a
toll-free number). Information requests may also be submitted by email
to [email protected].
SUPPLEMENTARY INFORMATION: This preamble is organized as follows:
I. Public Participation
II. Background
A. WTC Health Program Statutory Authority
B. Addition of New Health Conditions for Coverage in the WTC
Health Program
III. Summary of the Final Rule and Response to Comments
IV. 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
V. Final Rule
I. Public Participation
HHS received comments from six individuals and organizations on the
notice of proposed rulemaking published in the Federal Register on July
1, 2011 (76 FR 38938). One anonymous commenter expressed anger about
the WTC Health Program's cost to American taxpayers; another individual
asked that leukemia and other blood cancers be added to the list of
WTC-related health conditions; and a physician experienced with
treating WTC-related health conditions requested that a mental disorder
be added to the list of WTC-related health conditions. Those comments
are outside the scope of this rulemaking and could not be considered.
HHS received substantive comments from the New York State Laborers'
Health & Safety Trust Fund, the Communication Workers of America, and
the WTC Health Program Survivor Steering Committee. Those comments are
described and addressed below.
II. Background
A. WTC Health Program Statutory Authority
Title I of the James Zadroga 9/11 Health and Compensation Act of
2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act)
to add Title XXXIII \1\ establishing the WTC Health Program within HHS.
HHS issued an interim final rule on July 1, 2011 (76 FR 38914), which
codified the Program in 42 CFR Part 88. Sections 88.1 through 88.16
were included in that rulemaking; this final rule establishing Sec.
88.17 was developed in a separate rulemaking.
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\1\ Title XXXIII of the Public Health Service 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
World Trade Center Health Program and are codified elsewhere.
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The WTC Health Program provides medical monitoring and treatment
benefits to eligible firefighters and related personnel, law
enforcement officers, and rescue, recovery and cleanup workers
(including those who are Federal employees) who responded to the
September 11, 2001, terrorist attacks, and to eligible survivors of the
New York City attacks. The WTC Health Program will expand to include
eligible firefighters and related personnel, law enforcement officers,
and rescue, recovery and cleanup workers who responded to the September
11, 2001, terrorist attacks at the Pentagon and Shanksville, PA. The
WTC Program Administrator has gathered information that may serve as a
basis for such enrollment, and is working to develop eligibility
criteria for these responder groups.
All references to the WTC Program Administrator in this notice mean
the NIOSH Director or his or her designee.
Title XXXIII of the PHS Act authorizes the WTC Program
Administrator to establish a process by which health conditions,
including cancer, may be considered for addition to the list of WTC-
related health conditions. This final rule establishes this process.
B. Addition of New Health Conditions for Coverage in the WTC Health
Program
The list of WTC-related health conditions defined in sections 3312
and 3322 of Title XXXIII of the PHS Act may be amended in the future to
add other conditions for which exposure to airborne toxins, any other
hazard, or any other adverse condition resulting from the September 11,
2001, terrorist attacks, based on an examination by a medical
professional with experience in treating or diagnosing the health
conditions included in the applicable list of WTC-related health
conditions, is substantially likely to be a significant factor in
aggravating, contributing to, or causing the illness or condition
(Title XXXIII, Sec. 3312(a)(1)(A)(i)).
Procedures for the addition of a new condition are established in
this final rule. The addition of a new condition
[[Page 24629]]
could be initiated either by petition from an interested party or at
the discretion of the WTC Program Administrator, as specified in this
final rule.
III. Summary of Final Rule and Response to Comments
Section 88.1 Definitions
This amendment to Part 88 would add the definition of ``interested
party'' to the list of definitions established by interim final rule on
July 1, 2011 (76 FR 38914).
Comment: HHS received two comments requesting that the definition
of ``interested party'' be expanded to reference survivor
organizations.
HHS response: The definition of ``interested party'' was taken
directly from Title I of the James Zadroga 9/11 Health and Compensation
Act of 2010. Although the statutory definition of ``interested party''
does not explicitly mention ``survivor organizations,'' HHS believes
that the definition includes ``survivor organizations.'' HHS does not
agree that amending the rule text is necessary and is therefore not
amending the definition.
Section 88.17 Addition of Health Conditions to the List of WTC-Related
Health Conditions
In accordance with the requirements specified in Title XXXIII of
the PHS Act, Sec. 88.17 establishes the process by which an interested
party could petition the WTC Program Administrator to add a condition
to the list of WTC-related health conditions identified in Sec. 88.1.
Under the provisions of Sec. 88.17(a)(1), the petition must include
the name and contact information of the interested party; the name and
description of the condition the party would like the WTC Program
Administrator to add to the list of WTC-related health conditions; and
an explanation of the reasons for adding the condition, which must
include the medical basis for the association between the September 11,
2001, terrorist attacks and the condition to be added.
HHS has received some communications for which it is unclear
whether the author intends to petition for the addition of a health
condition or whether the author is expressing personal concerns. Since
a petition results in Federal action, as specified under this rule, it
is important that the intent to petition be unambiguous. Accordingly,
HHS has amended the final rule text to clarify that the petition must
state the petitioner's intent to petition for the addition of a health
condition.
The provisions of Sec. 88.17(a)(2) incorporate specifications in
Title XXXIII of the PHS Act regarding the addition of new conditions.
Within 60 days of receipt of the petition, the WTC Program
Administrator will either: request a recommendation of the WTC Health
Program Scientific/Technical Advisory Committee (STAC); open the
proposed condition to public comment by publishing a notice of proposed
rulemaking (NPRM) in the Federal Register; publish the WTC Program
Administrator's determination not to publish an NPRM; or publish in the
Federal Register a determination that not enough evidence exists to
perform any of the above actions. HHS has amended the final rule text
to acknowledge that a petition may request the addition of more than
one health condition.
HHS has also inserted Sec. 88.17(a)(4) into the final rule to
clarify that the Administrator shall be required to reconsider a
previously-considered (but not added) health condition for inclusion on
the list of WTC-related health conditions in response to a petition
only when the petition includes a new medical basis for the association
between the terrorist attacks and the condition. A new medical basis
could include a health study, whether original or updated, not
previously considered by the WTC Program Administrator. A new clinical
case report on a particular health condition which compiles data from
one or more patients may not necessarily be considered a new medical
basis if the Administrator has previously considered one or more cases
of the health condition. The Administrator retains the discretion,
however, to reconsider a health condition for any reason on his own
initiative, with or without the receipt of a petition.
Comment: One commenter requested that all submitted petitions be
shared with the STAC regardless of whether the WTC Program
Administrator seeks a formal recommendation from the Committee.
HHS response: HHS appreciates this suggestion and agrees that, in
the interest of keeping the STAC informed of relevant public interest,
petitions received by the WTC Program Administrator will be shared with
the Committee and with the public via the Program's Web site. HHS does
not believe that amending the rule text is warranted.
Comment: A commenter also asked that a mechanism be developed to
allow at least two members of the STAC to request to consider a
petition and make a recommendation in the event that the WTC Program
Administrator has determined not to publish an NPRM or where the
Administrator determines that insufficient evidence exists to take
action on a petition.
HHS response: According to the requirements of Title XXXIII of the
PHS Act, the Committee's role is to review evidence and make
recommendations to the WTC Program Administrator at the request of the
Administrator, not to provide unsolicited reviews. Any work conducted
by the STAC must be consistent with the purposes for which the
Committee may be utilized as identified by the statute and the
Committee charter. Therefore, this comment is not adopted.
Subsection (b) also incorporates the statutory requirement that the
WTC Program Administrator may publish an NPRM concerning the addition
of a WTC-related health condition to the list. The Administrator would
consider publishing an NPRM where the review of cancers required by
Sec. 3312(a)(5)(A) of Title XXXIII of the PHS Act indicates that a type
of cancer should be added, or where the review of WTC Health Program
monitoring data reveals the prevalence of a condition not previously
identified by the statute or Program. The protocol for such a review
will take into account an evaluation of the exposure data associated
with the terrorist attacks, and an evaluation of available
epidemiologic, toxicologic, and medical evidence relevant to evaluating
the possible association between the health condition under
consideration and exposures associated with the September 11, 2001,
terrorist attacks. How these various relevant sources of scientific and
medical information will be evaluated, separately and in relation to
each other, will depend on the evidence available for a given health
condition under consideration. HHS notes that scientists generally look
for consistency in terms of disease-mechanism theories, toxicologic and
epidemiologic findings, and medical observation. The addition of any
health condition requires rulemaking, and the public will have the
opportunity to consider and comment on the review methods applied in
any actual case.
The WTC Program Administrator may extend the comment period
described above based upon a finding of good cause. In the case of such
an extension, the Administrator shall publish notice in the Federal
Register.
Comment: HHS received several comments concerning deadlines not
specified in the regulatory text. One commenter suggested that HHS did
not include every deadline related to the addition of a WTC-related
health
[[Page 24630]]
condition provided by the statute. Two comments asked that we specify a
time frame for the publication of an NPRM or a Federal Register notice
indicating that the WTC Program Administrator has determined not to
publish an NPRM; one asked that we specify the publication of an NPRM
30 days following a STAC recommendation. Comments also requested that
we specify a time frame for publication of a final rule; one asked that
we require publication within 60 days after the close of an NPRM
comment period.
HHS response: Each deadline specified by the PHS Act with regard to
this matter has been incorporated into the regulatory text. We have
specified a time frame for the publication of an NPRM following a STAC
recommendation in Sec. 88.17(b)(2) according to the time frame
specified in the statute. We agree with commenters who pointed out that
we neglected to specify a time frame for publication of a Federal
Register notice indicating a decision not to publish an NPRM following
receipt of a STAC recommendation, and have amended the rule text
accordingly. However, Congress did not specify a time frame for
publication of a final rule. HHS is concerned that establishing such
requirements by regulation could negatively impact the thorough review
of scientific evidence supporting or opposing the inclusion of a
specific health condition. Because of the need to ensure that a
thorough review has been conducted in all cases, HHS is not making
changes to the rule based on these comments. Every effort will be made
to promptly review public comments and STAC recommendations, and that
publication of a final rule will occur in as efficient and timely a
manner as is possible.
Comment: One commenter requested that HHS develop procedures for
the WTC Program Administrator to notify an individual when a new
condition is added, if the individual was previously denied coverage
for that condition.
HHS response: Information about newly-added WTC-related health
conditions will be provided on the WTC Health Program Web site and
shared with all Program physicians. Program physicians would be best
placed to advise individuals on whether applying for certification of a
newly-designated WTC-related health condition is appropriate. The WTC
Health Program will consider this request further to identify other
ways in which Program participants may be notified of a new WTC-related
health condition.
IV. 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 of significant
regulatory actions 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). Executive Order 13563 emphasizes the importance
of quantifying both costs and benefits, of reducing costs, of
harmonizing rules, and of promoting flexibility.
This final rule is considered a ``significant regulatory action''
within the meaning of E.O. 12866. The rule establishes processes by
which the WTC Program Administrator may consider the addition of health
conditions to the current statutory list of WTC-related health
conditions covered by this program. This strictly procedural rule does
not itself propose the addition of any conditions and hence it does not
provide for any benefits nor impose any costs, other than the minor
incidental administrative costs to HHS of considering possible
additions. Under any circumstance, HHS would be required to conduct
rulemaking to make an addition, as required by Title XXXIII of the PHS
Act. Accordingly, any quantifiable costs and benefits associated with
adding a condition would be addressed in such future rulemaking.
This rule does not adversely affect in a material way the economy,
a sector of the economy, productivity, jobs, the environment, public
health or safety, or State, local, or Tribal governments or
communities; it does not create a serious inconsistency or otherwise
interfere with an action taken or planned by another agency; it does
not materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; nor does it raise novel legal or policy issues arising out of
legal mandates, the President's priorities, or the principles set forth
in E.O. 12866.
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
Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
This regulation has no impact on small businesses or other small
entities as specified under the RFA. The rule establishes procedures by
which the WTC Health Program Administrator may consider the addition of
health conditions to the current statutory list of WTC-related health
conditions covered by this program. These procedures do not impose any
requirements or direct costs on small entities. They do not involve
small entities, except that a small entity could potentially be
considered an ``interested party'' under these procedures, eligible to
petition the WTC Program Administrator for the addition of a health
condition.
The Secretary of HHS has certified to the Chief Counsel, Office of
Advocacy of the Small Business Administration, that this rule does not
have a significant impact on a substantial number of small entities.
Accordingly, no regulatory impact analysis is required.
C. Paperwork Reduction Act
HHS has determined that this final rule contains data collection
and record keeping requirements that are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1955 (44 U.S.C. 3501-3420). A description of these 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. These data collection and record keeping
requirements have been approved under OMB control number 0920-0929,
exp. April 30, 2015.
Project: Adding a Health Condition to the Statutory List of WTC-
Related Health Conditions (42 CFR 88.17)--New--National Institute for
Occupational Safety and Health (NIOSH), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description: Title I of the James Zadroga
Health and Compensation Act of 2010 amended the Public Health Service
Act (PHS Act) to establish the World Trade Center (WTC) Health Program.
Sections 3311, 3312, and 3321 of Title XXXIII of the PHS Act require
that the WTC Program Administrator develop regulations to implement
portions of the WTC Health Program established within the Department of
Health and Human
[[Page 24631]]
Services (HHS). This final rule establishes the processes by which the
WTC Program Administrator may add a new condition to the list of WTC-
related health conditions through rulemaking, including a process for
considering petitions by interested parties to add a new condition; the
process will be codified at 42 CFR 88.17.
Section 88.17, entitled ``Addition of Health Conditions to the List
of WTC-Related Health Conditions,'' describes the process and data
collection requirements that an interested party should follow to
petition the WTC Program Administrator to add a condition to the list
of WTC-related health conditions. HHS expects to receive no more than
100 petitions annually. We assume that interested parties will be
enrolled WTC responders, screening-eligible survivors, certified-
eligible survivors, or members of groups who advocate on behalf of
responders or survivors. We estimate that an individual will spend an
average of 40 hours gathering information to substantiate a request to
add a health condition and assembling the petition. HHS requests input
from the public on these estimates, which are reflected in the table
below. The total burden on the public is estimated to be 4,000 hours.
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Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
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Responder/Survivor/Advocate......... Petition for the 100 1 40
addition of health
conditions.
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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.), HHS 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 final 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 2011, the inflation adjusted
threshold is $136 million.
F. Executive Order 12988 (Civil Justice)
This final 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)
HHS has reviewed this final 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 final 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 final rule consistent with the Federal
Plain Writing Act guidelines.
V. Final Rule
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:
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 definition of ``interested party'' in
alphabetical order to read as follows:
Sec. 88.1 Definitions.
* * * * *
Interested party means a representative of any organization
representing WTC responders, a nationally recognized medical
association, a WTC Health Program Clinical Center of Excellence or Data
Center, a State or political subdivision, or any other interested
person.
* * * * *
0
3. Add Sec. 88.17 to read as follows:
Sec. 88.17 Addition of health conditions to the list of WTC-related
health conditions.
(a) Any interested party may petition the WTC Program Administrator
to add a condition to the list of WTC-related health conditions.
(1) Each petition shall state an intent to petition and be sent to
the WTC Program Administrator. The petition shall include:
(i) Name and contact information of the interested party;
(ii) Name and description of the condition(s) to be added; and
(iii) Reasons for adding the condition(s), including the medical
basis for the association between the September 11, 2001, terrorist
attacks and the condition(s) to be added.
(2) Not later than 60 days after the receipt of a petition, the WTC
Program Administrator shall:
(i) Request a recommendation of the WTC Health Program Scientific/
Technical Advisory Committee; or
[[Page 24632]]
(ii) Publish in the Federal Register a proposed rule to add such
health condition; or
(iii) Publish in the Federal Register the WTC Program
Administrator's determination not to publish a proposed rule and the
basis for that determination; or
(iv) Publish in the Federal Register a determination that
insufficient evidence exists to take action under paragraph (a)(2)(i)
through (iii) of this section.
(3) The WTC Program Administrator may consider more than one
petition simultaneously when the petitions propose the addition of the
same health condition. Scientific/Technical Advisory Committee
recommendations and Federal Register notices initiated by the WTC
Program Administrator pursuant to paragraph (a)(2) of this section may
respond to more than one petition.
(4) The WTC Program Administrator shall be required to consider a
new petition for a health condition previously reviewed by the WTC
Program Administrator and determined not to qualify for addition to the
list of WTC-related health conditions only if the new petition presents
a new medical basis (i.e., not previously reviewed) for the association
between the September 11, 2001, terrorist attacks and the condition to
be added.
(b) The WTC Program Administrator may propose to add a condition to
the list of WTC-related health conditions by publishing a proposed rule
in the Federal Register and providing interested parties a period of 30
days to submit written comments. The WTC Program Administrator may
extend the comment period for good cause.
(1) If the WTC Program Administrator requests a recommendation from
the WTC Health Program Scientific/Technical Advisory Committee, the
Advisory Committee shall submit its recommendation to the WTC Program
Administrator no later than 60 days after the date of the transmission
of the request or no later than a date specified by the Administrator
(but not more than 180 days after the request). If the WTC Program
Administrator decides to publish a proposed rule or a determination not
to publish a proposed rule in the Federal Register, he or she shall do
so no later than 60 days after the date of transmission of the Advisory
Committee recommendation.
(2) [Reserved]
Dated: January 26, 2012.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2012-9425 Filed 4-24-12; 8:45 am]
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