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[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Proposed Rules]
[Pages 38938-38942]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16511]

[[Page 38937]]

Vol. 76

Friday,

No. 127

July 1, 2011

Part VII

Department of Health and Human Services

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42 CFR Part 88

World Trade Center Health Program Requirements for the Addition of New 
WTC-Related Health Conditions; Proposed Rule

Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Proposed 
Rules

[[Page 38938]]

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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: Notice of proposed rulemaking.

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SUMMARY: 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 
Services (HHS). The WTC Health Program, which will be administered in 
part by the Director of the National Institute for Occupational Safety 
and Health (NIOSH), within the Centers for Disease Control and 
Prevention (CDC), will provide 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. 
The proposed 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: HHS invites written comments from interested parties on this 
notice of proposed rulemaking and on the proposed information 
collection request sought under the Paperwork Reduction Act. Comments 
must be received by August 30, 2011.

ADDRESSES: You may submit comments, identified by ``RIN 0920-AA45,'' by 
any of the following methods:
     Internet: Access the Federal e-rulemaking portal at http://www.regulations.gov. Follow the instructions for submitting comments.
     E-mail: NIOSH Docket Officer, nioshdocket@cdc.gov. Include 
``RIN 0920-AA45'' and ``42 CFR 88'' in the subject line of the message.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
    Instructions: All submissions received must include the agency name 
and docket number or Regulation Identifier Number (RIN) for this 
rulemaking. All comments will be posted without change to http://www.regulations.gov and http://www.cdc.gov/niosh/docket/NIOSHdocket0236.html, including any personal information provided. For 
detailed instructions on submitting comments and additional information 
on the rulemaking process, see the ``Public Participation'' heading of 
the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov or http://www.cdc.gov/niosh/docket/NIOSHdocket0236.html.

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 request may also be submitted by e-mail 
to wtcpublicinput@cdc.gov.

SUPPLEMENTARY INFORMATION: This preamble is organized as follows:

I. Public Participation
II. Background
    A. WTC Medical Monitoring and Treatment Program and Community 
Program History
    B. WTC Health Program Statutory Authority
    C. Addition of New Health Conditions for Coverage in the WTC 
Health Program
III. Summary of the Proposed Rule
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

I. Public Participation

    Interested persons or organizations are invited to participate in 
this rulemaking by submitting written views, opinions, recommendations, 
and data. Comments received, including attachments and other supporting 
materials, are part of the public record and subject to public 
disclosure. Do not include any information in your comment or 
supporting materials that you consider confidential or inappropriate 
for public disclosure. Comments are invited on any topic related to 
this proposed rule.

II. Background

A. WTC Medical Monitoring and Treatment Program and the WTC 
Environmental Health Center Community Program History

    Since the tragic events of September 11, 2001, HHS, CDC, and NIOSH 
have facilitated health evaluations for those firefighters and related 
personnel, law enforcement officers, and rescue, recovery and cleanup 
workers who responded to the WTC disaster sites. A health screening 
program for responders began in 2002 under contracts awarded to Mount 
Sinai School of Medicine (Mount Sinai) and the Fire Department, City of 
New York. Mount Sinai subcontracted with other specialty occupational 
health clinics in the New York metropolitan area to expand enrollment 
and provide a standardized and comprehensive health screening protocol.
    In 2003, Congress appropriated further funding to implement longer 
term medical monitoring for these responders. The occupational health 
specialty clinics involved in the screening program were each directly 
funded through cooperative agreements with NIOSH to work 
collaboratively and provide periodic standardized medical monitoring 
exams. Participants in the initial screening program were enrolled 
beginning in 2004.
    In 2006, Congress appropriated additional funds for diagnostic and 
treatment services to support medical care for health conditions 
associated with WTC-related work exposures. After receiving 
appropriations for treatment, the responder program was re-named the 
WTC Medical Monitoring and Treatment Program (MMTP) to reflect expanded 
services to eligible firefighters and related personnel, law 
enforcement officers, and rescue, recovery and cleanup workers. The 
established program providers were funded as Clinical Centers of 
Excellence (Clinical Centers) reflecting their multidisciplinary 
expertise and extensive program experience with the WTC responder 
population. The MMTP made monitoring exams and treatment

[[Page 38939]]

available to firefighters and related personnel, law enforcement 
officers, and rescue, recovery and cleanup workers living outside the 
New York metropolitan area and geographically distant from the 
established Clinical Centers through a network of providers. The health 
conditions covered under the MMTP were identified by the Clinical 
Centers based on assessments of the health needs of the firefighters 
and related personnel, law enforcement officers, and rescue, recovery 
and cleanup workers and with input from scientific and medical experts, 
and included certain upper and lower airway diseases, esophageal 
disorders from acid reflux, musculoskeletal injuries, and mental health 
problems (most notably post-traumatic stress disorder, anxiety, and 
depression).
    In 2008, Congress appropriated additional funds for the WTC 
Environmental Health Center (EHC) Community Program, which provided 
initial health evaluations, diagnostic and treatment services for 
residents, students, and others in the community who were affected by 
the September 11, 2001, terrorist attacks in New York City.

B. 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. 
The WTC Health Program will assume the functions and goals of the MMTP 
and the EHC Community Program to provide 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.
---------------------------------------------------------------------------

    \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 will expand the services of the MMTP 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. Section 3311(a)(2)(C)(ii) of Title XXXIII requires that the WTC 
Program Administrator develop eligibility criteria for Pentagon and 
Shanksville, PA emergency responders after consultation with the WTC 
Scientific/Technical Advisory Committee. However, because no Pentagon 
or Shanksville, PA responders have participated in the existing MMTP, 
the WTC Program Administrator currently lacks information that may 
serve as a basis for such enrollment, including information on 
participation in the response at these two sites and on hazard exposure 
circumstances at these sites relevant to currently established WTC 
health conditions. The WTC Program Administrator will be collecting 
such information.
    Title XXXIII of the PHS Act authorizes the Secretary of HHS to 
designate a Department official to be the WTC Program Administrator 
(Title XXXIII, Sec.  3306(14)). Certain specific activities of the WTC 
Program Administrator are reserved to the Secretary to delegate at her 
discretion; other WTC Program Administrator duties not explicitly 
reserved to the Secretary are assigned to the Director of NIOSH or his 
or her designee. This rule implements portions of the Act which were 
both given to the Director of NIOSH and others for which the HHS 
Secretary has designated the Director of NIOSH to be the WTC Program 
Administrator. Another HHS component, Centers for Medicare & Medicaid 
Services, has been delegated responsibilities for disbursing payments 
to providers under the WTC Health Program (see Delegation of Authority, 
76 FR 31337, May 31, 2011). All references to the WTC Program 
Administrator in this notice mean the NIOSH Director or his or her 
designee.
    Under section 3306 of Title XXXIII of the PHS Act, the WTC Program 
Administrator is responsible for a program to enroll qualified 
firefighters and related personnel, law enforcement officers, and 
rescue, recovery and cleanup workers who responded to the New York 
City, Pentagon, and Shanksville, PA disaster sites; screen and certify 
qualified survivors of the New York City attacks; and to establish a 
nationwide system of healthcare providers to provide monitoring and 
treatment to those individuals found eligible. The WTC Program 
Administrator is also required to promulgate regulations to determine 
medical necessity with respect to healthcare services and prescription 
pharmaceuticals; to certify WTC-related health conditions identified in 
the statute; and to establish processes for appealing adverse WTC 
Health Program determinations. Those statutory requirements are 
included in the interim final rule published elsewhere in this issue of 
the Federal Register.
    Title XXXIII of the PHS Act also 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. Those provisions are included in this NPRM.

C. 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, which include 
rulemaking as required by Title XXXIII, are proposed in this notice. 
The addition of a new condition could be initiated either by petition 
from an interested party or at the discretion of the WTC Program 
Administrator, as specified in this proposed rule.

III. Summary of Proposed Rule

Section 88.1 Definitions

    This amendment to Part 88 would add the definition of ``interested 
party'' to the list of definitions.

Section 88.17 Addition of Health Conditions to the List of WTC-Related 
Health Conditions

    Pursuant to requirements specified in Title XXXIII of the PHS Act, 
Sec.  88.17 would establish 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 (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 to see added 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. The provisions of (a)(2) would incorporate specifications in

[[Page 38940]]

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; open the proposed 
condition to public comment by publishing an 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. If 
the WTC Program Administrator receives more than one petition to add a 
specific health condition, the WTC Program Administrator could consider 
them simultaneously under the process established by the provisions of 
this section.
    Subsection (b) would also incorporate the statutory requirement 
that the WTC Program Administrator may, periodically, publish an NPRM 
concerning the addition of a WTC-related health condition. The 
Administrator would consider publishing an NPRM where the review of 
cancers required by Title XXXIII Sec.  3312(a)(5)(A) of the PHS Act 
indicates that a type of cancer should be added, or where WTC Health 
Program monitoring data reveals the prevalence of a condition not 
previously identified by the Program. Although the WTC Administrator 
cannot provide a specific scientific review protocol at this time, the 
protocol would take into account evaluating the exposure data 
associated with WTC and evaluating available published and unpublished 
epidemiologic, toxicologic, and medical evidence relevant to evaluating 
the possible association between the health condition under 
consideration and WTC exposures. How these various relevant sources of 
scientific and medical information will be evaluated, separately and in 
relation to each other would 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. HHS solicits comment on this and other 
approaches to reviewing evidence.
    The WTC Program Administrator may extend the period described above 
upon finding a good cause. In the case of such an extension, the 
Administrator shall publish such an extension in the Federal Register.

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 proposed 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 does not achieve 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 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. Such petitioning by a small entity would be voluntary, 
however, and hence any costs attendant to submitting a petition would 
be voluntarily incurred.
    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

    CDC has determined that this notice of proposed rulemaking contains 
information collection requirements that are subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
(PRA) of 1995 (44 U.S.C. 3501-1420). 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. In compliance with the requirement of Sec.  
3506(c)(2)(A) of the PRA for opportunity for public comment on proposed 
data collection projects, CDC will publish periodic summaries of 
proposed projects. To request more information on the proposed projects 
or to obtain a copy of the data collection plans and instruments, call 
404-639-5960 and send comments to Daniel Holcomb, CDC Reports Clearance 
Officer, 1600 Clifton Road, NE., MS-D74, Atlanta, GA 30333 or send an 
e-mail to omb@cdc.gov.
    Comments are invited on (a) whether the proposed collection of 
information

[[Page 38941]]

is necessary for the proper performance of the functions of the Agency, 
including whether the information shall have practical utility; (b) the 
accuracy of the Agency's estimate of the burden of the proposed 
collection of information; (c) ways to enhance the quality, utility, 
and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information on respondents. 
Written comments should be received within 60 days of this notice.
    Proposed Project: Adding a Health Condition to the Statutory List 
of WTC-Related Health Conditions (42 CFR 88)--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 Services (HHS). This proposed 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 new provision is proposed at Sec.  
88.17 Addition of health conditions to the list of WTC-related health 
conditions.
Sec.  88.17 Addition of Health Conditions to the List of WTC-Related 
Health Conditions
    This section describes the proposed 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, 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.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Number of      Average  burden
              Type of respondent                            Form name                 Number of       responses per     per  response     Total burden
                                                                                     respondents       respondent        (in hours)           hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Responder/Survivor/Advocate...................  Petition for the addition of                  100                 1                40             4,000
                                                 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 proposed rule would 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.

F. Executive Order 12988 (Civil Justice)

    This proposed 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 proposed 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 proposed rule on energy supply, distribution or use, 
and has determined that the rule will not have a significant adverse 
effect.

J. Plain Writing Act of 2010

    Under Public Law 111-274 (October 13, 2010), executive Departments 
and Agencies are required to use plain language in documents that 
explain to the public how to comply with a requirement the Federal 
Government administers or enforces. HHS has attempted to use plain 
language in promulgating the proposed rule consistent with the Federal 
Plain Writing Act guidelines.

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 proposes to amend 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 Sec.  88.1 by adding the definition of ``interested 
party'' to read as follows:

[[Page 38942]]

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.
* * * * *
    2. 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 be in writing and 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 to be added; and
    (iii) Reasons for adding the condition, including the medical basis 
for the association between the September 11, 2001, terrorist attacks 
and the condition 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
    (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.
    (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).
    (2) If the WTC Program Administrator decides 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.

    Dated: May 6, 2011.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2011-16511 Filed 6-29-11; 8:45 am]
BILLING CODE 4163-18-P
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