World Trade Center Health Program Requirements for the Addition of New WTC-Related Health Conditions, 24628-24632 [2012-9425]
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Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
[FR Doc. 2012–9965 Filed 4–24–12; 8:45 am]
BILLING CODE 6560–50–P
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
Centers for Disease Control and
Prevention, HHS.
ACTION: Final rule.
AGENCY:
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 WTCrelated 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
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SUMMARY:
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submitted by email to
wtcpublicinput@cdc.gov.
This
preamble is organized as follows:
SUPPLEMENTARY INFORMATION:
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 WTCrelated 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.
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 § 88.17 was developed in a
separate rulemaking.
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.
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
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
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.
II. Background
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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.
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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,
§ 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 § 88.1.
Under the provisions of § 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.
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The provisions of § 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 § 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
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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 diseasemechanism 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
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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.
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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-forprofit organizations. HHS believes that
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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
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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,
Type of respondent
power and responsibilities among the
various levels of government.’’
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.
H. Executive Order 13045 (Protection of
Children From Environmental Health
Risks and Safety Risks)
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.
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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
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Number of
responses
per
respondent
Average
burden per
response
(in hours)
100
1
40
Petition for the addition of health conditions
D. Small Business Regulatory
Enforcement Fairness Act
E. Unfunded Mandates Reform Act of
1995
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.
Number of
respondents
Form name
Responder/Survivor/Advocate ........................
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
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Human Services amends 42 CFR part 88
as follows:
■ 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
definition of ‘‘interested party’’ in
alphabetical order to read as follows:
■
§ 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.
*
*
*
*
*
■ 3. Add § 88.17 to read as follows:
§ 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
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(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]
VerDate Mar<15>2010
16:02 Apr 24, 2012
Jkt 226001
Dated: January 26, 2012.
Kathleen Sebelius,
Secretary, Department of Health and Human
Services.
[FR Doc. 2012–9425 Filed 4–24–12; 8:45 am]
BILLING CODE P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 14
[CG Docket No. 10–213 and 10–145, WT
Docket No. 96–198; FCC 11–151]
Implementing the Provisions of the
Communications Act of 1934, as
Enacted by the Twenty-First Century
Communications and Video
Accessibility Act of 2010
Federal Communications
Commission.
ACTION: Final rule; announcement of
effective date.
AGENCY:
In this document, the
Commission announces that the Office
of Management and Budget (OMB) has
approved, for a period of three years, the
information collection associated with
the Commission’s document
Implementing the Provisions of the
Communications Act of 1934, as
Enacted by the Twenty-First Century
Communications and Video
Accessibility Act of 2010, (Report and
Order). This notice is consistent with
the Report and Order, which stated that
the Commission would publish a
document in the Federal Register
announcing the effective date of those
rules.
DATES: The amendments to 47 CFR 14.5,
14.20(d), 14.31, 14.32, and 14.34
through 14.52, published at 76 FR
82354, December 30, 2011, are effective
April 25, 2012.
FOR FURTHER INFORMATION CONTACT:
Rosaline Crawford, Disability Rights
Office, Consumer and Governmental
Affairs Bureau, at (202) 418–2075, or
email Rosaline.Crawford@fcc.gov.
SUPPLEMENTARY INFORMATION: This
document announces that, on April 16,
2012, OMB approved, for a period of
three years, the information collection
requirements contained in the
Commission’s Report and Order, FCC
11–151, published at 76 FR 82354,
December 30, 2011. The OMB Control
Number is 3060–1167. The Commission
publishes this notice as an
announcement of the effective date of
the rules. If you have any comments on
the burden estimates listed below, or
how the Commission can improve the
collections and reduce any burdens
SUMMARY:
PO 00000
Frm 00048
Fmt 4700
Sfmt 4700
caused thereby, please contact Cathy
Williams, Federal Communications
Commission, Room 1–C823, 445 12th
Street SW., Washington, DC 20554.
Please include the OMB Control
Number, 3060–1167, in your
correspondence. The Commission will
also accept your comments via the
Internet if you send them to
PRA@fcc.gov <mailto:PRA@fcc.gov>.
To request materials in accessible
formats for people with disabilities
(Braille, large print, electronic files,
audio format), send an email to
fcc504@fcc.gov <mailto:fcc504@fcc.gov>
or call the Consumer and Governmental
Affairs Bureau at (202) 418–0530
(voice), (202) 418–0432 (TTY).
Synopsis
As required by the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507),
the FCC is notifying the public that it
received OMB approval on April 16,
2012, for the information collection
requirements contained in the
Commission’s rules at 47 CFR 14.5,
14.20(d), 14.31, 14.32, and 14.34
through 14.52.
Under 5 CFR 1320, an agency may not
conduct or sponsor a collection of
information unless it displays a current,
valid OMB Control Number.
No person shall be subject to any
penalty for failing to comply with a
collection of information subject to the
Paperwork Reduction Act that does not
display a current, valid OMB Control
Number. The OMB Control Number is
3060–1167.
The foregoing notice is required by
the Paperwork Reduction Act of 1995,
Pub. L. 104–13, October 1, 1995, and
44 U.S.C. 3507.
The total annual reporting burdens
and costs for the respondents are as
follows:
OMB Control Number: 3060–1167.
OMB Approval Date: April 16, 2012.
OMB Expiration Date: April 30, 2015.
Title: Accessible Telecommunications
and Advanced Communications
Services and Equipment.
Form Number: N/A.
Type of Review: New collection.
Respondents: Individuals or
households; businesses or other forprofit entities; not-for-profit institutions.
Number of Respondents and
Responses: 9,454 respondents; 119,660
responses.
Estimated Time per Response: .50 to
40 hours.
Frequency of Response: Annual, one
time, and on occasion reporting
requirements; recordkeeping
requirement; third-party disclosure
requirement.
Obligation to Respond: Mandatory.
Statutory authority for this information
E:\FR\FM\25APR1.SGM
25APR1
]]>Agencies
[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Rules and Regulations]
[Pages 24628-24632]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9425]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 wtcpublicinput@cdc.gov.
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Responder/Survivor/Advocate......... Petition for the 100 1 40
addition of health
conditions.
----------------------------------------------------------------------------------------------------------------
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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