In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.

SECTION 1. SHORT TITLE.

This Act may be cited as the ''Helping Effective Antibiotics Last
Act of 2015'' or the ''HEAL Act''.

SEC. 2. APPROVAL OF CERTAIN DRUGS FOR USE IN A WELL-DEFINED POPULATION
OF PATIENTS.

(a) Approval of Certain Antibacterial.--Section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at
the end the following:
''(x) Approval of Certain Antibacterial Drugs for Use in a Well-
Defined Population of Patients.--
''(1) Unmet medical need defined.--In this subsection, the
term 'unmet medical need' means that the antibacterial drug
involved--
''(A) has improved efficacy, as demonstrated in
adequate, well-controlled studies in humans, for
specific diseases or conditions, where current
therapies have been shown to be less effective;
''(B) has clinically meaningful decreased harms,
demonstrated in adequate, well-controlled studies in
humans, for diseases or conditions, where current
therapies have unacceptable adverse effects; or
''(C) has improved convenience, as demonstrated in
adequate, well-controlled studies in humans, where
improved convenience results in improved effectiveness
or decreased harms.
''(2) Approval.--Upon receipt of an application under
subsection (b) for an antibacterial drug that is intended to
treat a serious or life-threatening disease or condition,
irrespective of whether the drug is intended to address an
unmet medical need, the Secretary--
''(A) may approve the drug under subsection (c)
only for treating a well-defined population of
patients, and based upon the results of clinical trials
inclusive of human subjects representative of such
well-defined population;
''(B) in determining whether to grant such
approval, shall rely on superior outcomes over
available therapies based on direct measures of patient
benefits, as demonstrated in adequate, well-controlled
studies in the well-defined patient population, such
as--
''(i) decreased mortality;
''(ii) irreversible morbidity; or
''(iii) validated surrogate endpoints that
reflect mortality or irreversible morbidity;
and
''(C) shall require the labeling of drugs approved
pursuant to this subsection to prominently include in
the prescribing information required by section 201.57
of title 21, Code of Federal Regulations (or any
successor regulation)--
''(i) the population of patients with
respect to which the added benefit over
available therapies is expected as studied in
adequate, well-controlled studies that form the
basis for approval; and
''(ii) the method for identifying members
of that population.
''(3) Risk evaluation and mitigation strategy.--The
Secretary--
''(A) shall require a risk evaluation and
mitigation strategy (REMS) under section 505-1 for each
drug approved under this subsection; and
''(B) may include in any such strategy additional
elements to assure the safe use of the drug under
subsections (e) and (f) of section 505-1.
''(4) Rule of construction.--Nothing in this subsection
shall be construed to alter the standards of evidence under
subsection (c) or (d) (including the substantial evidence
standard in subsection (d)). Subsections (c) and (d) and such
standards of evidence apply to the review and approval of drugs
under this subsection, including whether a drug is safe and
effective. Nothing in this subsection shall be construed to
limit the authority of the Secretary to approve products
pursuant to this Act and the Public Health Service Act as
authorized prior to the date of enactment of this subsection.
''(5) Effective immediately.--The Secretary shall have the
authorities vested in the Secretary by this subsection
beginning on the date of enactment of this subsection,
irrespective of when and whether the Secretary promulgates
final regulations to carry out this subsection.''.
(b) Licensure of Certain Biological Products.--Section 351(j) of
the Public Health Service Act (42 U.S.C. 262(j)) is amended--
(1) by striking ''(j)'' and inserting ''(j)(1)'';
(2) by inserting ''505(x),'' after ''505(p),''; and
(3) by adding at the end the following:
''(2) In applying section 505(x) of the Federal Food, Drug, and
Cosmetic Act to the licensure of biological products under this
section--
''(A) references to an antibacterial drug with added
benefits over available therapies for a well-defined population
that is intended to treat a serious or life-threatening disease
or condition shall be construed to refer to biological products
with added benefits over available therapies for a well-defined
population intended to treat a bacterial infection associated
with a serious or life-threatening disease; and
''(B) references to an application submitted under section
505(b) of such Act and to approval of a drug under section
505(c) of such Act shall be construed to refer to an
application submitted under subsection (a) of this section and
to licensure of a biological product under such subsection (a),
respectively.''.
(c) Monitoring.--Title III of the Public Health Service Act is
amended by inserting after section 317T (42 U.S.C. 247b-22) the
following:

''SEC. 317U. MONITORING OF ANTIBACTERIAL DRUG USE, PATIENT OUTCOMES,
AND RESISTANCE.

''(a) Monitoring.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall use the National
Healthcare Safety Network or another appropriate monitoring system to
monitor--
''(1) changes in patient outcomes such as mortality and
irreversible morbidity causally related to antibacterial
resistance; and
''(2) changes in bacterial resistance to drugs in relation
to patient outcomes.
''(b) Public Availability of Data.--The Secretary, acting through
the Director of the Centers for Disease Control and Prevention, shall
make the data derived from monitoring under this section publicly
available for the purposes of--
''(1) improving the monitoring of important trends in
patient outcomes in relation to antibacterial resistance; and
''(2) ensuring appropriate stewardship of antibacterial
drugs, including those receiving approval or licensure for a
well-defined population pursuant to section 505(x) of the
Federal Food, Drug, and Cosmetic Act.''.

SEC. 3. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR MICROBIAL
ORGANISMS.

(a) In General.--Section 511 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360a) is amended to read as follows:

''SEC. 511. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR MICROBIAL
ORGANISMS.

''(a) In General.--The Secretary shall--
''(1) identify upon approval or licensing of antibacterial
drugs (including biological products intended to treat a
bacterial infection and other types of antimicrobial drugs, as
deemed appropriate by the Secretary), including qualified
infectious disease products, susceptibility test interpretive
criteria for such drugs based upon patient outcomes of
mortality and morbidity from adequate and well-controlled
studies and such other confirmatory evidence as the Secretary
deems necessary; and
''(2) update, consistent with subsection (b), such criteria
as needed based upon scientific evidence of changes in patient
outcomes.
''(b) Responding to Changes in Patient Outcomes To Evaluate
Susceptibility Test Interpretive Criteria.--
''(1) In general.--As needed based on evidence related to
changes in patient outcomes, the Secretary shall--
''(A) evaluate any new scientific studies on
changes in patient outcomes in relation to
susceptibility test interpretive criteria; and
''(B) publish on the public Website of the Food and
Drug Administration a notice--
''(i) presenting suggested new or updated
interpretive criteria; and
''(ii) if needed, hold a public advisory
committee to discuss scientific evidence
related to changes in interpretative criteria.
''(2) Annual compilation of notices.--Each year, the
Secretary shall compile the notices published under paragraph
(1)(B) noting any changes from prior notices and publish such
compilation in the Federal Register.
''(c) Definition.--In this section, the term 'susceptibility test
interpretive criteria' means one or more specific values which
characterize patient outcomes in relation to the degree to which
bacteria or other microbes are more resistant to treatment as measured
by patient outcomes.''.
(b) Conforming Amendment.--Section 1111 of the Food and Drug
Administration Amendments Act of 2007 (42 U.S.C. 247d-5a; relating to
identification of clinically susceptible concentrations of
antimicrobials) is repealed.
(c) Report to Congress.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human Services shall
submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report on the progress made in implementing
section 511 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360a), as amended by this section.

SEC. 4. REQUIRING DEMONSTRATION OF SUPERIOR OUTCOMES FOR QUALIFIED
INFECTIOUS DISEASE PRODUCTS TO RECEIVE AN EXTENDED
EXCLUSIVITY PERIOD.

Section 505E(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355f(g)) is amended by striking ''means an antibacterial or
antifungal drug for human use intended to treat'' and inserting ''means
an antibacterial or antifungal drug for human use that is demonstrated
to produce superior outcomes over available therapies, based on direct
measures of patient benefits in clinical trials, and that is intended
to treat''.

SEC. 5. GUIDANCE ON TARGET PRODUCT PROFILES.

Not later than 18 months after the date of enactment of this Act,
the Commissioner of Food and Drugs, in consultation with the
Administrator of the Centers for Medicare & Medicaid Services, the
Director of the Indian Health Service, the Secretary of Defense, and
the Secretary of Veterans Affairs, shall issue guidance on the
development of target product profiles for novel antibacterial drugs
focused on public health priorities.
Helping Effective Antibiotics Last Act of 2015 or the HEAL Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to approve an antibacterial drug or biological product that is intended to treat a serious or life-threatening condition only for treating a well-defined population of patients. To be approved, the antibacterial product must produce superior outcomes over available therapies in the well-defined patient population. A product approved by this pathway must include in its prescribing information the population of patients expected to benefit from using the product and the method for identifying members of that population. The FDA must require each product to have a risk evaluation and mitigation strategy. The Centers for Disease Control and Prevention must monitor changes to bacterial drug resistance and changes to patient outcomes caused by bacterial drug resistance. Upon approval of antibacterial products, the FDA must identify susceptibility test interpretive criteria (the drug concentrations where a type of bacteria is categorized as susceptible, intermediate, or resistant) and update the criteria as needed based upon evidence of changes in patient outcomes. To be eligible for an exclusivity period extension, a qualified infectious disease product must be demonstrated to produce superior outcomes over available therapies. The FDA must issue guidance on the development of target product profiles for antibacterial drugs.

SECTION 1. SHORT TITLE.

This Act may be cited as the ''Student Non-Discrimination Act of
2011''.

SEC. 2. FINDINGS AND PURPOSES.

(a) Findings.--The Congress finds the following:
(1) Public school students who are lesbian, gay, bisexual
or transgender (LGBT), or are perceived to be LGBT, or who
associate with LGBT people, have been and are subjected to
pervasive discrimination, including harassment, bullying,
intimidation and violence, and have been deprived of equal
educational opportunities, in schools in every part of our
Nation.
(2) While discrimination, including harassment, bullying,
intimidation and violence, of any kind is harmful to students
and to our education system, actions that target students based
on sexual orientation or gender identity represent a distinct
and especially severe problem.
(3) Numerous social science studies demonstrate that
discrimination, including harassment, bullying, intimidation
and violence, at school has contributed to high rates of
absenteeism, dropout, adverse health consequences, and academic
underachievement among LGBT youth.
(4) When left unchecked, discrimination, including
harassment, bullying, intimidation and violence, in schools
based on sexual orientation or gender identity can lead, and
has lead to, life-threatening violence and to suicide.
(5) Public school students enjoy a variety of
constitutional rights, including rights to equal protection,
privacy, and free expression, which are infringed when school
officials engage in discriminatory treatment or are indifferent
to discrimination, including harassment, bullying, intimidation
and violence, on the basis of sexual orientation or gender
identity.
(6) While Federal statutory protections expressly address
discrimination on the basis of race, color, sex, religion,
disability, and national origin, Federal civil rights statutes
do not expressly include ''sexual orientation'' or ''gender
identity''. As a result, students and parents have often had
limited legal recourse to redress for discrimination on the
basis of sexual orientation or gender identity.
(b) Purposes.--The purposes of this Act are--
(1) to ensure that all students have access to public
education in a safe environment free from discrimination,
including harassment, bullying, intimidation and violence, on
the basis of sexual orientation or gender identity;
(2) to provide a comprehensive Federal prohibition of
discrimination in public schools based on actual or perceived
sexual orientation or gender identity;
(3) to provide meaningful and effective remedies for
discrimination in public schools based on actual or perceived
sexual orientation or gender identity;
(4) to invoke congressional powers, including but not
limited to the power to enforce the 14th Amendment to the
Constitution and to provide for the general welfare pursuant to
section 8 of article I of the Constitution and the power to
enact all laws necessary and proper for the execution of the
foregoing powers pursuant to section 8 of article I of the
Constitution, in order to prohibit discrimination in public
schools on the basis of sexual orientation or gender identity;
and
(5) to allow the Department of Education to effectively
combat discrimination based on sexual orientation or gender
identity in public schools through regulation and enforcement,
as the Department has issued regulations under and enforced
title IX of the Education Amendments of 1972 and other
nondiscrimination laws in a manner that effectively addresses
discrimination.

SEC. 3. DEFINITIONS.

For purposes of this Act:
(1) Program or activity.--The terms ''program or activity''
and ''program'' have same meanings given such terms as applied
under section 606 of the Civil Rights Act of 1964 (42 U.S.C.
2000d-4a) to the operations of public entities under paragraph
(2)(B) of such section.
(2) Gender identity.--The term ''gender identity'' means
the gender-related identity, appearance, or mannerisms or other
gender-related characteristics of an individual, with or
without regard to the individual's designated sex at birth.
(3) Harassment.--The term ''harassment'' means conduct that
is sufficiently severe, persistent, or pervasive to limit a
student's ability to participate in or benefit from a public
school education program or activity, or to create a hostile or
abusive educational environment at a public school, including
acts of verbal, nonverbal, or physical aggression,
intimidation, or hostility, if such conduct is based on--
(A) a student's actual or perceived sexual
orientation or gender identity; or
(B) the actual or perceived sexual orientation or
gender identity of a person or persons with whom a
student associates or has associated.
(4) Public schools.--The term ''public schools'' means
public elementary and secondary schools, including local
educational agencies, educational service agencies, and State
educational agencies, as defined in section 9101 of the
Elementary and Secondary Education Act of 1965.
(5) Sexual orientation.--The term ''sexual orientation''
means homosexuality, heterosexuality, or bisexuality.
(6) Student.--The term ''student'' means an individual who
is enrolled in a public school or who, regardless of official
enrollment status, attends classes or participates in a public
school's programs or educational activities.

SEC. 4. PROHIBITION AGAINST DISCRIMINATION; EXCEPTIONS.

(a) In General.--No student shall, on the basis of actual or
perceived sexual orientation or gender identity of such individual or
of a person with whom the student associates or has associated, be
excluded from participation in, or be denied the benefits of, or be
subjected to discrimination under any program or activity receiving
Federal financial assistance.
(b) Harassment.--For purposes of this Act, discrimination includes,
but is not limited to, harassment of a student on the basis of actual
or perceived sexual orientation or gender identity of such student or
of a person with whom the student associates or has associated.
(c) Retaliation Prohibited.--
(1) Prohibition.--No person shall be excluded from
participation in, be denied the benefits of, or be subjected to
discrimination, retaliation, or reprisal under any program or
activity receiving Federal financial assistance based on his or
her opposition to conduct made unlawful by this Act.
(2) Definition.--For purposes of this subsection,
''opposition to conduct made unlawful by this Act'' includes,
but is not limited to--
(A) opposition to conduct reasonably believed to be
made unlawful by this Act,
(B) any formal or informal report, whether oral or
written, to any governmental entity, including public
schools and employees thereof, regarding conduct made
unlawful by this Act or reasonably believed to be made
unlawful by this Act,
(C) participation in any investigation, proceeding,
or hearing related to conduct made unlawful by this Act
or reasonably believed to be made unlawful by this Act,
and
(D) assistance or encouragement provided to any
other person in the exercise or enjoyment of any right
granted or protected by this Act,
if in the course of that expression, the person involved does
not purposefully provide information known to be false to any
public school or other governmental entity regarding a
violation, or alleged violation, of this Act.

SEC. 5. FEDERAL ADMINISTRATIVE ENFORCEMENT; REPORT TO CONGRESSIONAL
COMMITTEES.

Each Federal department and agency which is empowered to extend
Federal financial assistance to any education program or activity, by
way of grant, loan, or contract other than a contract of insurance or
guaranty, is authorized and directed to effectuate the provisions of
section 4 of this Act with respect to such program or activity by
issuing rules, regulations, or orders of general applicability which
shall be consistent with achievement of the objectives of the Act
authorizing the financial assistance in connection with which the
action is taken. No such rule, regulation, or order shall become
effective unless and until approved by the President. Compliance with
any requirement adopted pursuant to this section may be effected--
(1) by the termination of or refusal to grant or to
continue assistance under such program or activity to any
recipient as to whom there has been an express finding on the
record, after opportunity for hearing, of a failure to comply
with such requirement, but such termination or refusal shall be
limited to the particular political entity, or part thereof, or
other recipient as to whom such a finding has been made, and
shall be limited in its effect to the particular program, or
part thereof, in which such noncompliance has been so found, or
(2) by any other means authorized by law,
except that no such action shall be taken until the department or
agency concerned has advised the appropriate person or persons of the
failure to comply with the requirement and has determined that
compliance cannot be secured by voluntary means. In the case of any
action terminating, or refusing to grant or continue, assistance
because of failure to comply with a requirement imposed pursuant to
this section, the head of the Federal department or agency shall file
with the committees of the House and Senate having legislative
jurisdiction over the program or activity involved a full written
report of the circumstances and the grounds for such action. No such
action shall become effective until 30 days have elapsed after the
filing of such report.

SEC. 6. CAUSE OF ACTION.

(a) Cause of Action.--Subject to subsection (c) of this section, an
aggrieved individual may assert a violation of this Act in a judicial
proceeding. Aggrieved persons may be awarded all appropriate relief,
including but not limited to equitable relief, compensatory damages,
cost of the action, and remedial action.
(b) Rule of Construction.--This section shall not be construed to
preclude an aggrieved individual from obtaining other remedies under
any other provision of law or to require such individual to exhaust any
administrative complaint process or notice-of-claim requirement before
seeking redress under this section.
(c) Statute of Limitations.--For actions brought pursuant to this
section, the statute of limitations period shall be determined in
accordance with section 1658(a) of title 28 of the United States Code.
The tolling of any such limitations period shall be determined in
accordance with the law governing actions under section 1979 of the
Revised Statutes (42 U.S.C. 1983) in the forum State.

SEC. 7. STATE IMMUNITY.

(a) State Immunity.--A State shall not be immune under the 11th
Amendment to the Constitution of the United States from suit in Federal
court for a violation of this Act.
(b) Waiver.--A State's receipt or use of Federal financial
assistance for any program or activity of a State shall constitute a
waiver of sovereign immunity, under the 11th Amendment to the
Constitution or otherwise, to a suit brought by an aggrieved individual
for a violation of section 4 of this Act.
(c) Remedies.--In a suit against a State for a violation of this
Act, remedies (including remedies both at law and in equity) are
available for such a violation to the same extent as such remedies are
available for such a violation in the suit against any public or
private entity other than a State.

SEC. 8. ATTORNEY'S FEES.

Section 722(b) of the Revised Statutes (42 U.S.C. 1988(b)) is
amended by inserting ''the Student Nondiscrimination Act of 2011,''
after ''Religious Land Use and Institutionalized Persons Act of
2000,''.

SEC. 9. EFFECT ON OTHER LAWS.

(a) Federal and State Nondiscrimination Laws.--Nothing in this Act
shall be construed to preempt, invalidate, or limit rights, remedies,
procedures, or legal standards available to victims of discrimination
or retaliation under any other Federal law or law of a State or
political subdivision of a State, including title VI of the Civil
Rights Act of 1964 (42 U.S.C. 2000d et seq.), title IX of the Education
Amendments of 1972 (20 U.S.C. 1681 et seq.), section 504 of the
Rehabilitation Act of 1973 (29 U.S.C. 794), the Americans with
Disabilities Act of 1990 (42 U.S.C. 12101 et seq.), or section 1979 of
the Revised Statutes (42 U.S.C. 1983). The obligations imposed by this
Act are in addition to those imposed by title IX of the Education
Amendments of 1972 (20 U.S.C. 1681 et seq.), title VI of the Civil
Rights Act of 1964 (42 U.S.C. 2000d et seq.), and the Americans with
Disabilities Act of 1990 (42 U.S.C. 12101 et seq.).
(b) Free Speech and Expression Laws and Religious Student Groups.--
Nothing in this Act shall be construed to alter legal standards
regarding, or affect the rights available to individuals or groups
under, other Federal laws that establish protections for freedom of
speech and expression, such as legal standards and rights available to
religious and other student groups under the 1st Amendment to the
Constitution and the Equal Access Act (20 U.S.C. 4071 et seq.).

SEC. 10. SEVERABILITY.

If any provision of this Act, or any application of such provision
to any person or circumstance, is held to be unconstitutional, the
remainder of this Act, and the application of the provision to any
other person or circumstance shall not be affected.

SEC. 11. EFFECTIVE DATE.

This Act shall take effect 60 days after the date of the enactment
of this Act and shall not apply to conduct occurring before the
effective date of this Act.
Student Non-Discrimination Act of 2011 - Prohibits public school students from being excluded from participating in, or subject to discrimination under, any federally-assisted educational program on the basis of their actual or perceived sexual orientation or gender identity or that of their associates.

Considers harassment to be a form of discrimination.

Prohibits retaliation against anyone for opposing conduct they reasonably believe to be unlawful under this Act.

Authorizes federal departments and agencies to enforce these prohibitions by cutting off the educational assistance of recipients found to be violating them.

Allows an aggrieved individual to assert a violation of this Act in a judicial proceeding and recover reasonable attorney's fees should they prevail.

Deems a state's receipt of federal educational assistance for a program to constitute a waiver of sovereign immunity for conduct prohibited under this Act regarding such program.

SECTION 1. SHORT TITLE.

This Act may be cited as the ''Health Care Waiver Fairness Act of
2011''.

SEC. 2. PPACA WAIVER PROCESS.

(a) In General.--Title I of the Patient Protection and Affordable
Care Act (Public Law 111-148) is amended by adding at the end the
following new subtitle:

''Subtitle G--Waiver Process

''SEC. 1601. ESTABLISHMENT OF WAIVER PROCESS.

''(a) In General.--The applicable authorities (as defined in
subsection (c)) shall collectively establish a process (in this section
referred to as the 'waiver process') under which the administrator of a
health plan, an employer, an individual, or other entity may seek to
waive the application of a requirement under this title with respect to
such plan, employer, individual, or entity. Among the requirements
under this title, such process shall apply to the following:
''(1) Section 5000A of the Internal Revenue Code of 1986
(relating to requirement to maintain minimum essential
coverage), as inserted by section 1501(b).
''(2) Section 6055 of the Internal Revenue Code of 1986
(relating to reporting of health insurance coverage), as
inserted by section 1502(a).
''(3) Section 18A of the Fair Labor Standards Act of 1938
(42 U.S.C. 218a, relating to automatic enrollment for employees
of large employers), as inserted by section 1511.
''(4) Section 18B of the Fair Labor Standards Act of 1938
(42 U.S.C. 218b, relating to notice to employees), as inserted
by section 1512.
''(5) Section 4980H of the Internal Revenue Code of 1986
(relating to shared responsibility for employers regarding
health coverage), as inserted by section 1513(a).
''(6) Section 6056 of the Internal Revenue Code of 1986
(relating to certain employers required to report on health
insurance coverage), as inserted by section 1514(a).
''(7) Section 10108 (relating to free choice vouchers).
''(8) Regulations regarding the treatment of group health
plans or health insurance coverage as a grandfathered health
plan (as defined in section 1251(e)).
''(9) Section 2718(b) of the Public Health Service Act
(relating to medical loss ratios), as inserted by section 1001.
''(b) Waiver Process.--
''(1) In general.--The applicable authorities shall
establish the waiver process consistent with the following:
''(A) Notice and guidance.--Public notice and
guidance shall be provided regarding the process for
submission of waiver requests.
''(B) Standard.--A waiver request with respect to
the application of a requirement to a plan, employer,
individual, or entity shall be accompanied by a
statement that--
''(i) identifies the specific requirement
(or requirements) to be waived; and
''(ii) describes how the imposition of each
specific requirement for which a waiver is
requested on the plan, employer, individual, or
entity would result in a significant decrease
in access to coverage or a significant increase
in premiums or other costs for such plan,
employer, individual, or entity.
''(C) Deemed approval.--A waiver request filed that
is accompanied by such a statement shall be deemed to
be approved.
''(D) Publication of data.--The applicable
authorities shall regularly publish data regarding the
waiver requests received for the different
requirements.
''(2) Treatment of approved waivers.--In the case of
approval under the waiver process of a waiver request with
respect to a requirement of this title and an entity,
notwithstanding any other provision of law, such requirement
shall not apply to such entity on and after the date of
approval of the request.
''(3) Relation to other exemptions and exceptions.--Nothing
in this section shall be construed as superceding other
provisions of this title insofar as they provide for
exceptions, exemptions, or other special treatment with respect
to requirements under this title.
''(c) Applicable Authority.--In this section, the term 'applicable
authority' means--
''(1) except as otherwise provided in this subsection, the
Secretary of Health and Human Services;
''(2) the Secretary of Labor with respect to the provisions
of this title, including amendments made by this title, that
are administered by such Secretary; and
''(3) the Secretary of the Treasury with respect to the
provisions of this title, including amendments made by this
title, that are administered by such Secretary, including
sections of the Internal Revenue Code of 1986 specified in
subsection (a).
''(d) References to Requirements Under This Title.--In this
section, a reference to a requirement under this title include such a
requirement under an amendment made by this title, including as amended
by title X of this Act or by the provisions of the Health Care and
Education Reconciliation Act of 2010 (Public Law 111-152).
''(e) Public Awareness Campaign.--Of the amounts available in the
Prevention and Public Health Fund established under section 4002,
notwithstanding any other provision of law, $50,000,000 shall be
available to and expended by the Secretary of Health and Human Services
to conduct, in coordination with other applicable authorities, a public
awareness campaign of the waiver process. Amounts made available under
this subsection shall remain available until expended.''.
(b) Clerical Amendment.--The table of contents of such Act is
amended by adding at the end of the items relating to title I the
following:

''Subtitle G--Waiver Process

''Sec. 1601. Establishment of waiver process.''.
Health Care Waiver Fairness Act of 2011 - Amends the Patient Protection and Affordable Care Act (PPACA) to require the Secretary of Health and Human Services (HHS), the Secretary of Labor, and the Secretary of Treasury to establish waiver processes under which the administrator of a health plan, an employer, an individual, or other entity may seek to waive the application of a health insurance coverage requirement under PPACA. Sets forth PPACA requirements that may be waived, including those related to minimum essential coverage and employers offering health care coverage to employees.

Establishes requirements for the waiver process, including requiring submission of a statement describing how the imposition of the PPACA requirement would result in a significant decrease in access to coverage or a significant increase in premiums or other costs for such plan, employer, individual, or entity. Deems to be approved any waiver including such a statement.

Requires the Secretary of HHS to conduct a public awareness campaign of the waiver process with funds made available for the Prevention and Public Health Fund.