[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Proposed Rules]
[Pages 38938-38942]
From the Federal Register Online via the Government Publishing 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, [email protected]. 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 [email protected].
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.
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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 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 [email protected].
Comments are invited on (a) whether the proposed collection of
information
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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.
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Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
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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