[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]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. CDC-2011-0010]

42 CFR Part 88

RIN 0920-AA45


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

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Final rule.

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SUMMARY: Title I of the James Zadroga 9/11 Health and Compensation Act 
of 2010 amended the Public Health Service Act (PHS Act) to establish 
the World Trade Center (WTC) Health Program. Sections 3311, 3312, and 
3321 of Title XXXIII of the PHS Act require that the WTC Program 
Administrator develop regulations to implement portions of the WTC 
Health Program established within the Department of Health and Human 
Services (HHS). The WTC Health Program, which is administered by the 
Director of the National Institute for Occupational Safety and Health 
(NIOSH), within the Centers for Disease Control and Prevention (CDC), 
provides medical monitoring and treatment to eligible firefighters and 
related personnel, law enforcement officers, and rescue, recovery and 
cleanup workers who responded to the September 11, 2001, terrorist 
attacks in New York City, Shanksville, PA, and at the Pentagon, and to 
eligible survivors of the New York City attacks. This final rule 
establishes the processes by which the WTC Program Administrator may 
add a new condition to the list of WTC-related health conditions 
through rulemaking, including a process for considering petitions by 
interested parties to add a new condition.

DATES: This final rule is effective May 25, 2012.

FOR FURTHER INFORMATION CONTACT: Roy M. Fleming, Sc.D., Senior Science 
Advisor, World Trade Center Health Program, Office of the Director, 
National Institute for Occupational Safety and Health, 1600 Clifton 
Road NE., MS-E74, Atlanta, GA 30329; telephone 866-426-3673 (this is a 
toll-free number). Information requests may also be submitted by email 
to 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.
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    \1\ Title XXXIII of the Public Health Service Act is codified at 
42 U.S.C. 300mm to 300mm-61. Those portions of the Zadroga Act found 
in Titles II and III of Public Law 111-347 do not pertain to the 
World Trade Center Health Program and are codified elsewhere.
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    The WTC Health Program provides medical monitoring and treatment 
benefits to eligible firefighters and related personnel, law 
enforcement officers, and rescue, recovery and cleanup workers 
(including those who are Federal employees) who responded to the 
September 11, 2001, terrorist attacks, and to eligible survivors of the 
New York City attacks. The WTC Health Program will expand to include 
eligible firefighters and related personnel, law enforcement officers, 
and rescue, recovery and cleanup workers who responded to the September 
11, 2001, terrorist attacks at the Pentagon and Shanksville, PA. The 
WTC Program Administrator has gathered information that may serve as a 
basis for such enrollment, and is working to develop eligibility 
criteria for these responder groups.
    All references to the WTC Program Administrator in this notice mean 
the NIOSH Director or his or her designee.
    Title XXXIII of the PHS Act authorizes the WTC Program 
Administrator to establish a process by which health conditions, 
including cancer, may be considered for addition to the list of WTC-
related health conditions. This final rule establishes this process.

B. Addition of New Health Conditions for Coverage in the WTC Health 
Program

    The list of WTC-related health conditions defined in sections 3312 
and 3322 of Title XXXIII of the PHS Act may be amended in the future to 
add other conditions for which exposure to airborne toxins, any other 
hazard, or any other adverse condition resulting from the September 11, 
2001, terrorist attacks, based on an examination by a medical 
professional with experience in treating or diagnosing the health 
conditions included in the applicable list of WTC-related health 
conditions, is substantially likely to be a significant factor in 
aggravating, contributing to, or causing the illness or condition 
(Title XXXIII, Sec. 3312(a)(1)(A)(i)).
    Procedures for the addition of a new condition are established in 
this final rule. The addition of a new condition

[[Page 24629]]

could be initiated either by petition from an interested party or at 
the discretion of the WTC Program Administrator, as specified in this 
final rule.

III. Summary of Final Rule and Response to Comments

Section 88.1 Definitions

    This amendment to Part 88 would add the definition of ``interested 
party'' to the list of definitions established by interim final rule on 
July 1, 2011 (76 FR 38914).
    Comment: HHS received two comments requesting that the definition 
of ``interested party'' be expanded to reference survivor 
organizations.
    HHS response: The definition of ``interested party'' was taken 
directly from Title I of the James Zadroga 9/11 Health and Compensation 
Act of 2010. Although the statutory definition of ``interested party'' 
does not explicitly mention ``survivor organizations,'' HHS believes 
that the definition includes ``survivor organizations.'' HHS does not 
agree that amending the rule text is necessary and is therefore not 
amending the definition.

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

    In accordance with the requirements specified in Title XXXIII of 
the PHS Act, Sec.  88.17 establishes the process by which an interested 
party could petition the WTC Program Administrator to add a condition 
to the list of WTC-related health conditions identified in Sec.  88.1. 
Under the provisions of Sec.  88.17(a)(1), the petition must include 
the name and contact information of the interested party; the name and 
description of the condition the party would like the WTC Program 
Administrator to add to the list of WTC-related health conditions; and 
an explanation of the reasons for adding the condition, which must 
include the medical basis for the association between the September 11, 
2001, terrorist attacks and the condition to be added.
    HHS has received some communications for which it is unclear 
whether the author intends to petition for the addition of a health 
condition or whether the author is expressing personal concerns. Since 
a petition results in Federal action, as specified under this rule, it 
is important that the intent to petition be unambiguous. Accordingly, 
HHS has amended the final rule text to clarify that the petition must 
state the petitioner's intent to petition for the addition of a health 
condition.
    The provisions of Sec.  88.17(a)(2) incorporate specifications in 
Title XXXIII of the PHS Act regarding the addition of new conditions. 
Within 60 days of receipt of the petition, the WTC Program 
Administrator will either: request a recommendation of the WTC Health 
Program Scientific/Technical Advisory Committee (STAC); open the 
proposed condition to public comment by publishing a notice of proposed 
rulemaking (NPRM) in the Federal Register; publish the WTC Program 
Administrator's determination not to publish an NPRM; or publish in the 
Federal Register a determination that not enough evidence exists to 
perform any of the above actions. HHS has amended the final rule text 
to acknowledge that a petition may request the addition of more than 
one health condition.
    HHS has also inserted Sec.  88.17(a)(4) into the final rule to 
clarify that the Administrator shall be required to reconsider a 
previously-considered (but not added) health condition for inclusion on 
the list of WTC-related health conditions in response to a petition 
only when the petition includes a new medical basis for the association 
between the terrorist attacks and the condition. A new medical basis 
could include a health study, whether original or updated, not 
previously considered by the WTC Program Administrator. A new clinical 
case report on a particular health condition which compiles data from 
one or more patients may not necessarily be considered a new medical 
basis if the Administrator has previously considered one or more cases 
of the health condition. The Administrator retains the discretion, 
however, to reconsider a health condition for any reason on his own 
initiative, with or without the receipt of a petition.
    Comment: One commenter requested that all submitted petitions be 
shared with the STAC regardless of whether the WTC Program 
Administrator seeks a formal recommendation from the Committee.
    HHS response: HHS appreciates this suggestion and agrees that, in 
the interest of keeping the STAC informed of relevant public interest, 
petitions received by the WTC Program Administrator will be shared with 
the Committee and with the public via the Program's Web site. HHS does 
not believe that amending the rule text is warranted.
    Comment: A commenter also asked that a mechanism be developed to 
allow at least two members of the STAC to request to consider a 
petition and make a recommendation in the event that the WTC Program 
Administrator has determined not to publish an NPRM or where the 
Administrator determines that insufficient evidence exists to take 
action on a petition.
    HHS response: According to the requirements of Title XXXIII of the 
PHS Act, the Committee's role is to review evidence and make 
recommendations to the WTC Program Administrator at the request of the 
Administrator, not to provide unsolicited reviews. Any work conducted 
by the STAC must be consistent with the purposes for which the 
Committee may be utilized as identified by the statute and the 
Committee charter. Therefore, this comment is not adopted.
    Subsection (b) also incorporates the statutory requirement that the 
WTC Program Administrator may publish an NPRM concerning the addition 
of a WTC-related health condition to the list. The Administrator would 
consider publishing an NPRM where the review of cancers required by 
Sec. 3312(a)(5)(A) of Title XXXIII of the PHS Act indicates that a type 
of cancer should be added, or where the review of WTC Health Program 
monitoring data reveals the prevalence of a condition not previously 
identified by the statute or Program. The protocol for such a review 
will take into account an evaluation of the exposure data associated 
with the terrorist attacks, and an evaluation of available 
epidemiologic, toxicologic, and medical evidence relevant to evaluating 
the possible association between the health condition under 
consideration and exposures associated with the September 11, 2001, 
terrorist attacks. How these various relevant sources of scientific and 
medical information will be evaluated, separately and in relation to 
each other, will depend on the evidence available for a given health 
condition under consideration. HHS notes that scientists generally look 
for consistency in terms of disease-mechanism theories, toxicologic and 
epidemiologic findings, and medical observation. The addition of any 
health condition requires rulemaking, and the public will have the 
opportunity to consider and comment on the review methods applied in 
any actual case.
    The WTC Program Administrator may extend the comment period 
described above based upon a finding of good cause. In the case of such 
an extension, the Administrator shall publish notice in the Federal 
Register.
    Comment: HHS received several comments concerning deadlines not 
specified in the regulatory text. One commenter suggested that HHS did 
not include every deadline related to the addition of a WTC-related 
health

[[Page 24630]]

condition provided by the statute. Two comments asked that we specify a 
time frame for the publication of an NPRM or a Federal Register notice 
indicating that the WTC Program Administrator has determined not to 
publish an NPRM; one asked that we specify the publication of an NPRM 
30 days following a STAC recommendation. Comments also requested that 
we specify a time frame for publication of a final rule; one asked that 
we require publication within 60 days after the close of an NPRM 
comment period.
    HHS response: Each deadline specified by the PHS Act with regard to 
this matter has been incorporated into the regulatory text. We have 
specified a time frame for the publication of an NPRM following a STAC 
recommendation in Sec. 88.17(b)(2) according to the time frame 
specified in the statute. We agree with commenters who pointed out that 
we neglected to specify a time frame for publication of a Federal 
Register notice indicating a decision not to publish an NPRM following 
receipt of a STAC recommendation, and have amended the rule text 
accordingly. However, Congress did not specify a time frame for 
publication of a final rule. HHS is concerned that establishing such 
requirements by regulation could negatively impact the thorough review 
of scientific evidence supporting or opposing the inclusion of a 
specific health condition. Because of the need to ensure that a 
thorough review has been conducted in all cases, HHS is not making 
changes to the rule based on these comments. Every effort will be made 
to promptly review public comments and STAC recommendations, and that 
publication of a final rule will occur in as efficient and timely a 
manner as is possible.
    Comment: One commenter requested that HHS develop procedures for 
the WTC Program Administrator to notify an individual when a new 
condition is added, if the individual was previously denied coverage 
for that condition.
    HHS response: Information about newly-added WTC-related health 
conditions will be provided on the WTC Health Program Web site and 
shared with all Program physicians. Program physicians would be best 
placed to advise individuals on whether applying for certification of a 
newly-designated WTC-related health condition is appropriate. The WTC 
Health Program will consider this request further to identify other 
ways in which Program participants may be notified of a new WTC-related 
health condition.

IV. Regulatory Assessment Requirements

A. Executive Order 12866 and Executive Order 13563

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives of significant 
regulatory actions and, if regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety effects, distributive 
impacts, and equity). Executive Order 13563 emphasizes the importance 
of quantifying both costs and benefits, of reducing costs, of 
harmonizing rules, and of promoting flexibility.
    This final rule is considered a ``significant regulatory action'' 
within the meaning of E.O. 12866. The rule establishes processes by 
which the WTC Program Administrator may consider the addition of health 
conditions to the current statutory list of WTC-related health 
conditions covered by this program. This strictly procedural rule does 
not itself propose the addition of any conditions and hence it does not 
provide for any benefits nor impose any costs, other than the minor 
incidental administrative costs to HHS of considering possible 
additions. Under any circumstance, HHS would be required to conduct 
rulemaking to make an addition, as required by Title XXXIII of the PHS 
Act. Accordingly, any quantifiable costs and benefits associated with 
adding a condition would be addressed in such future rulemaking.
    This rule does not adversely affect in a material way the economy, 
a sector of the economy, productivity, jobs, the environment, public 
health or safety, or State, local, or Tribal governments or 
communities; it does not create a serious inconsistency or otherwise 
interfere with an action taken or planned by another agency; it does 
not materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; nor does it raise novel legal or policy issues arising out of 
legal mandates, the President's priorities, or the principles set forth 
in E.O. 12866.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 
requires each agency to consider the potential impact of its 
regulations on small entities including small businesses, small 
governmental units, and small not-for-profit organizations. HHS 
believes that this rule has ``no significant economic impact upon a 
substantial number of small entities'' within the meaning of the 
Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
    This regulation has no impact on small businesses or other small 
entities as specified under the RFA. The rule establishes procedures by 
which the WTC Health Program Administrator may consider the addition of 
health conditions to the current statutory list of WTC-related health 
conditions covered by this program. These procedures do not impose any 
requirements or direct costs on small entities. They do not involve 
small entities, except that a small entity could potentially be 
considered an ``interested party'' under these procedures, eligible to 
petition the WTC Program Administrator for the addition of a health 
condition.
    The Secretary of HHS has certified to the Chief Counsel, Office of 
Advocacy of the Small Business Administration, that this rule does not 
have a significant impact on a substantial number of small entities. 
Accordingly, no regulatory impact analysis is required.

C. Paperwork Reduction Act

    HHS has determined that this final rule contains data collection 
and record keeping requirements that are subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
of 1955 (44 U.S.C. 3501-3420). A description of these provisions is 
given below with an estimate of the annual reporting burden. Included 
in the estimate of the annual reporting burden is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information. These data collection and record keeping 
requirements have been approved under OMB control number 0920-0929, 
exp. April 30, 2015.
    Project: Adding a Health Condition to the Statutory List of WTC-
Related Health Conditions (42 CFR 88.17)--New--National Institute for 
Occupational Safety and Health (NIOSH), Centers for Disease Control and 
Prevention (CDC).
    Background and Brief Description: Title I of the James Zadroga 
Health and Compensation Act of 2010 amended the Public Health Service 
Act (PHS Act) to establish the World Trade Center (WTC) Health Program. 
Sections 3311, 3312, and 3321 of Title XXXIII of the PHS Act require 
that the WTC Program Administrator develop regulations to implement 
portions of the WTC Health Program established within the Department of 
Health and Human

[[Page 24631]]

Services (HHS). This final rule establishes the processes by which the 
WTC Program Administrator may add a new condition to the list of WTC-
related health conditions through rulemaking, including a process for 
considering petitions by interested parties to add a new condition; the 
process will be codified at 42 CFR 88.17.
    Section 88.17, entitled ``Addition of Health Conditions to the List 
of WTC-Related Health Conditions,'' describes the process and data 
collection requirements that an interested party should follow to 
petition the WTC Program Administrator to add a condition to the list 
of WTC-related health conditions. HHS expects to receive no more than 
100 petitions annually. We assume that interested parties will be 
enrolled WTC responders, screening-eligible survivors, certified-
eligible survivors, or members of groups who advocate on behalf of 
responders or survivors. We estimate that an individual will spend an 
average of 40 hours gathering information to substantiate a request to 
add a health condition and assembling the petition. HHS requests input 
from the public on these estimates, which are reflected in the table 
below. The total burden on the public is estimated to be 4,000 hours.

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                                                                                   Number of     Average  burden
         Type of respondent                  Form name            Number of      responses  per   per  response
                                                                 respondents       respondent       (in hours)
----------------------------------------------------------------------------------------------------------------
Responder/Survivor/Advocate.........  Petition for the                    100                1               40
                                       addition of health
                                       conditions.
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D. Small Business Regulatory Enforcement Fairness Act

    As required by Congress under the Small Business Regulatory 
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), HHS will 
report the promulgation of this rule to Congress prior to its effective 
date.

E. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 
et seq.) directs agencies to assess the effects of Federal regulatory 
actions on State, local, and Tribal governments, and the private sector 
``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' For purposes of the 
Unfunded Mandates Reform Act, this final rule does not include any 
Federal mandate that may result in increased annual expenditures in 
excess of $100 million by State, local or Tribal governments in the 
aggregate, or by the private sector. For 2011, the inflation adjusted 
threshold is $136 million.

F. Executive Order 12988 (Civil Justice)

    This final rule has been drafted and reviewed in accordance with 
Executive Order 12988, ``Civil Justice Reform,'' and will not unduly 
burden the Federal court system. This rule has been reviewed carefully 
to eliminate drafting errors and ambiguities.

G. Executive Order 13132 (Federalism)

    HHS has reviewed this final rule in accordance with Executive Order 
13132 regarding federalism, and has determined that it does not have 
``federalism implications.'' The rule does not ``have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''

H. Executive Order 13045 (Protection of Children From Environmental 
Health Risks and Safety Risks)

    In accordance with Executive Order 13045, HHS has evaluated the 
environmental health and safety effects of this rule on children. HHS 
has determined that the rule would have no environmental health and 
safety effect on children.

I. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)

    In accordance with Executive Order 13211, HHS has evaluated the 
effects of this final rule on energy supply, distribution or use, and 
has determined that the rule will not have a significant adverse 
effect.

J. Plain Writing Act of 2010

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

V. Final Rule

List of Subjects in 42 CFR Part 88

    Aerodigestive disorders, Appeal procedures, Health care, Mental 
health conditions, Musculoskeletal disorders, Respiratory and pulmonary 
diseases.

Text of the Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services amends 42 CFR part 88 as follows:

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

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


0
2. Amend Sec.  88.1 by adding the definition of ``interested party'' in 
alphabetical order to read as follows:


Sec.  88.1  Definitions.

* * * * *
    Interested party means a representative of any organization 
representing WTC responders, a nationally recognized medical 
association, a WTC Health Program Clinical Center of Excellence or Data 
Center, a State or political subdivision, or any other interested 
person.
* * * * *

0
3. Add Sec.  88.17 to read as follows:


Sec.  88.17  Addition of health conditions to the list of WTC-related 
health conditions.

    (a) Any interested party may petition the WTC Program Administrator 
to add a condition to the list of WTC-related health conditions.
    (1) Each petition shall state an intent to petition and be sent to 
the WTC Program Administrator. The petition shall include:
    (i) Name and contact information of the interested party;
    (ii) Name and description of the condition(s) to be added; and
    (iii) Reasons for adding the condition(s), including the medical 
basis for the association between the September 11, 2001, terrorist 
attacks and the condition(s) to be added.
    (2) Not later than 60 days after the receipt of a petition, the WTC 
Program Administrator shall:
    (i) Request a recommendation of the WTC Health Program Scientific/
Technical Advisory Committee; or

[[Page 24632]]

    (ii) Publish in the Federal Register a proposed rule to add such 
health condition; or
    (iii) Publish in the Federal Register the WTC Program 
Administrator's determination not to publish a proposed rule and the 
basis for that determination; or
    (iv) Publish in the Federal Register a determination that 
insufficient evidence exists to take action under paragraph (a)(2)(i) 
through (iii) of this section.
    (3) The WTC Program Administrator may consider more than one 
petition simultaneously when the petitions propose the addition of the 
same health condition. Scientific/Technical Advisory Committee 
recommendations and Federal Register notices initiated by the WTC 
Program Administrator pursuant to paragraph (a)(2) of this section may 
respond to more than one petition.
    (4) The WTC Program Administrator shall be required to consider a 
new petition for a health condition previously reviewed by the WTC 
Program Administrator and determined not to qualify for addition to the 
list of WTC-related health conditions only if the new petition presents 
a new medical basis (i.e., not previously reviewed) for the association 
between the September 11, 2001, terrorist attacks and the condition to 
be added.
    (b) The WTC Program Administrator may propose to add a condition to 
the list of WTC-related health conditions by publishing a proposed rule 
in the Federal Register and providing interested parties a period of 30 
days to submit written comments. The WTC Program Administrator may 
extend the comment period for good cause.
    (1) If the WTC Program Administrator requests a recommendation from 
the WTC Health Program Scientific/Technical Advisory Committee, the 
Advisory Committee shall submit its recommendation to the WTC Program 
Administrator no later than 60 days after the date of the transmission 
of the request or no later than a date specified by the Administrator 
(but not more than 180 days after the request). If the WTC Program 
Administrator decides to publish a proposed rule or a determination not 
to publish a proposed rule in the Federal Register, he or she shall do 
so no later than 60 days after the date of transmission of the Advisory 
Committee recommendation.
    (2) [Reserved]

    Dated: January 26, 2012.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2012-9425 Filed 4-24-12; 8:45 am]
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