SECTION 1. REDUCTIONS IN CONTRIBUTIONS TO MULTIEMPLOYER PLANS TO
              IMPLEMENT SELF-HELP MEASURES ADOPTED BY LABOR AND
              MANAGEMENT.

    (a) Amendments to ERISA.--Section 305 of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1085) is amended--
            (1) by redesignating subsection (i) as subsection (j); and
            (2) by inserting after subsection (h) the following:
    ``(i) Discretion To Accept Reduced Contributions.--
            ``(1) In general.--Notwithstanding any other provision of
        this section, during the funding plan adoption period, funding
        improvement period, rehabilitation plan adoption period, and
        the rehabilitation period, the Pension Benefit Guaranty
        Corporation may permit a plan sponsor to accept from an
        employer a ratified collective bargaining agreement with
        respect to the multiemployer plan that provides for a reduction
        in the level of contributions made by a contributing employer
        and appropriate reduction in level of future benefit accruals
        for any participants for a period of not more than 5 years (or
        such shorter period as determined by such Corporation) provided
        that such Corporation determines that--
                    ``(A) the contributing employer will be unable to
                pay its debts when due and will be unable to continue
                business without a reduction in its contribution rates;
                    ``(B) the aggregate withdrawal liability of the
                contributing employer with respect to all multiemployer
                pension plans exceeds $750,000,000, or such lower
                amount as determined to be appropriate by such
                Corporation;
                    ``(C) there is substantial doubt as to the
                collectability of the withdrawal liability if the
                contributing employer were to withdraw from the plan;
                    ``(D) the reduced contributions are not reasonably
                expected to have an adverse effect on the deficit of
                such Corporation;
                    ``(E) other creditors, stakeholders, and other
                parties to which the contributing employer is obligated
                have accepted reductions that are comparable to those
                of the pension plan; and
                    ``(F) such other conditions are satisfied as may be
                imposed in accordance with regulations prescribed by
                such Corporation.
            ``(2) Impact on withdrawal liability determinations.--Any
        reduction in the level of contributions under this subsection
        shall be disregarded in determining any limitation on annual
        payments under subparagraphs (B) and (C) of section 4219(c)(1)
        and in determining withdrawal liability under section 4201 with
        respect to the employer subject to the reduced contribution
        rate.''.
    (b) Amendments to Internal Revenue Code.--Section 432 of the
Internal Revenue Code of 1986 is amended--
            (1) by redesignating subsection (i) as subsection (j); and
            (2) by inserting after subsection (h) the following:
    ``(i) Discretion To Accept Reduced Contributions.--
            ``(1) In general.--Notwithstanding any other provision of
        this section, during the funding plan adoption period, funding
        improvement period, rehabilitation plan adoption period, and
        the rehabilitation period, the Pension Benefit Guaranty
        Corporation may permit a plan sponsor to accept from an
        employer a ratified collective bargaining agreement with
        respect to the multiemployer plan that provides for a reduction
        in the level of contributions made by a contributing employer
        and appropriate reduction in level of future benefit accruals
        for any participants for a period of not more than 5 years (or
        such shorter period as determined by such Corporation) provided
        that such Corporation determines that--
                    ``(A) the contributing employer will be unable to
                pay its debts when due and will be unable to continue
                business without a reduction in its contribution rates;
                    ``(B) the aggregate withdrawal liability of the
                contributing employer with respect to all multiemployer
                pension plans exceeds $750,000,000, or such lower
                amount as determined by such Corporation;
                    ``(C) there is substantial doubt as to the
                collectability of the withdrawal liability if the
                contributing employer were to withdraw from the plan;
                    ``(D) the reduced contributions are not reasonably
                expected to have an adverse effect on the deficit of
                such Corporation;
                    ``(E) other creditors, stakeholders, and other
                parties to which the contributing employer is obligated
                have accepted reductions that are comparable to those
                of the pension plan; and
                    ``(F) such other conditions are satisfied as may be
                imposed in accordance with regulations prescribed by
                such Corporation.
            ``(2) Impact on withdrawal liability determinations.--Any
        reduction in the level of contributions under this subsection
        shall be disregarded in determining any limitation on annual
        payments under subparagraphs (B) and (C) of section 4219(c)(1)
        of the Employee Retirement Income Security Act of 1974 and in
        determining withdrawal liability under section 4201 of such Act
        with respect to the employer subject to the reduced
        contribution rate.''.
    (c) Technical and Conforming Amendments.--
            (1) Section 4971(g)(4)(C)(ii) of the Internal Revenue Code
        of 1986 is amended by striking ``432(i)(9)'' and inserting
        ``432(j)(9)''.
            (2) Sections 101(f)(2)(B) and 103(f)(1)(B) of the Employee
        Retirement Income Security Act of 1974 (29 U.S.C. 1021(f)(2)(B)
        and 1023(f)(1)(B)) are each amended by striking ``305(i)'' each
        place such term appears and inserting ``305(j)''.

Summary: Amends the Employee Retirement Income Security Act of 1974 (ERISA) and the Internal Revenue Code to authorize the Pension Benefit Guaranty Corporation (PBGC), provided certain conditions are met, to allow the sponsor of an underfunded multiemployer benefit plan to accept from an employer a ratified collective bargaining agreement that provides for a reduction in plan employer contributions as well as appropriate reduction in the level of future benefit accruals for plan participants for up to five years during the plan funding adoption period, funding improvement period, rehabilitation adoption period, and rehabilitation period. Conditions such an allowance upon the PBGC's determination that: (1) the contributing employer will be unable to pay its debts when due and to continue business without a reduction in its contribution rates. (2) the contributing employer's aggregate withdrawal liability with respect to all multiemployer pension plans exceeds $750 million. (3) the collectability of the withdrawal liability is very doubtful if the contributing employer were to withdraw from the plan. (4) the reduced contributions are not reasonably expected to have an adverse effect on the PBGC deficit. And (5) other creditors, stakeholders, and parties to which the contributing employer is obligated have accepted comparable reductions.

To provide for private-sector solutions to certain pension funding challenges, and for other purposes.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Accountability in Foster Care Act''.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) Key child welfare laws, such as the Adoption and Safe
        Families Act of 1997 (Public Law 105-89) and the John H. Chafee
        Foster Care Independence Act of 1999 (Public Law 106-169),
        emphasize the importance of monitoring States performances in
        providing for the safety, permanency, stability, and well-being
        of children in and emancipated from the foster care system via
        measurable outcome data.
            (2) Child welfare experts and government agents have
        identified serious problems with current efforts to measure
        program functioning related to children in foster care and
        emancipated youth, including--
                    (A) Performance measures that prohibit examining
                children or success over time, overestimate the
                proportion of children reunified with families, and
                fail to consider the nature of the children (such as
                the severity of their problems, their age, and their
                urbanicity) served that could affect determinations of
                a State's success;
                    (B) The failure of the Department of Health and
                Human Services to implement the National Youth in
                Transition Database to monitor States' performance
                related to youth aging out of the foster care system,
                as mandated by the Foster Care Independence Act of
                1999; and
                    (C) Findings by the Government Accountability
                Office that effective Federal oversight of the child
                welfare system requires reliable information on States'
                implementation efforts and that the ability of the
                Administration of Children and Families to monitor
                State performance continues to be hindered by an
                absence of standard, comprehensive information within
                and across State plans on each State's goals, services,
                and youth outcomes as measured against baselines of
                past achievement.

SEC. 3. ADVISORY PANEL ON THE ADOPTION AND FOSTER CARE ANALYSIS AND
              REPORTING SYSTEM.

    (a) Establishment.--Not later than 90 days after the date of the
enactment of this subsection, the Secretary shall establish an Advisory
Panel (in this Act referred to as the ``Advisory Panel'') on the
Adoption and Foster Care Analysis and Reporting System (in this Act
referred to as ``AFCARS'') to revise and monitor the data collection,
analysis, and reporting system designed to be used to assess and
improve State performance in operating child protection and child
welfare programs pursuant to parts B and E of title IV of the Social
Security Act.
    (b) Functions.--The Advisory Panel established under subsection (a)
shall--
            (1) no later than 6 months after its appointment, make
        written recommendations for changes in law or data collection
        procedures necessary to revise AFCARS to enable the revised
        AFCARS to--
                    (A) longitudinally track child-specific outcomes
                (including maltreatment in foster care, number of
                foster care placements, maltreatment in foster care,
                and time to reunification, adoption, or legal
                guardianship) for children in or who have exited the
                foster care system through emancipation, adoption, or
                legal guardianship, developing appropriate timeframes
                for following children after exiting the system;
                    (B) collect and analyze entry and exit cohort data;
                    (C) be integrated with the National Youth in
                Transition Database to promote efficiency in data
                collection and to allow States to examine the
                relationships between the experiences of youths while
                in care and later transition outcomes; and
                    (D) include outcome measures of child well-being
                (including education, health, mental health, and
                connection to adults);
            (2) monitor the implementation of these AFCARS improvements
        and propose improvements to other State performance measures
        related to provision of services to children and families, by--
                    (A) convening not less frequently than annually to
                evaluate the quality of the revised AFCARS and make
                recommendations to the Secretary of Health and Human
                Services for continuing improvement in the quality of
                the system of data collection, analysis, and reporting;
                    (B) developing a uniform reporting format for the
                Child and Family Services Plan and the Annual Progress
                and Services Report in developing services for children
                and families; and
                    (C) proposing performance standards that allow for
                differences among States and characteristics among
                populations served (such as differences in the severity
                of problems faced by the population, age of the
                population, or urbanicity of the population) in
                understanding States performance; and
            (3) examining the feasibility of linking AFCARS and the
        National Child Abuse and Neglect Data Systems (NCANDS) to
        understand longitudinal outcomes of children who may be in both
        systems.
    (c) Membership.--
            (1) In general.--Subject to paragraph (2), the Secretary of
        Health and Human Services shall determine the membership and
        organization of the Advisory Panel.
            (2) Qualifications.--The membership of the Advisory Panel
        shall include--
                    (A) representatives of State and local governmental
                agencies with responsibility for foster care and
                adoption services, which may include caseworkers
                responsible for input data used for AFCARS or other
                Federal child welfare data reporting systems;
                    (B) representatives of research organizations and
                universities who focus on child welfare issues;
                    (C) representatives of private, nonprofit
                organizations with an interest in child protection and
                child welfare, including those with demonstrated
                expertise in developing effective child welfare
                assessment tools;
                    (D) representatives of Federal agencies responsible
                for the collection of child welfare data and
                statistics;
                    (E) representatives of families of former foster
                children, including adoptive parents or guardians; and
                    (F) representatives of juvenile, family, or
                dependency courts.
    (d) Use of Alternative Longitudinal Measures by States.--Until
final regulations providing for implementation of the recommendations
made pursuant to this section are promulgated, the Secretary shall
assess the extent to which a State is in compliance with a corrective
action plan pursuant to section 1123A of the Social Security Act
through use of such alternative longitudinal measures as the State may
select.
    (e) Permanency.--Section 14(a)(2) of the Federal Advisory Committee
Act (5 U.S.C. App.) shall not apply to the Advisory Board.

SEC. 4. REGULATIONS TO REVISE THE ADOPTION AND FOSTER CARE ANALYSIS AND
              REPORTING SYSTEM.

    (a) Notice of Proposed Regulations.--Not later than 12 months after
the date of the enactment of this Act, the Secretary of Health and
Human Services shall cause to be published in the Federal Register a
notice of proposed regulations to revise AFCARS which details the plans
and timetable for implementing the regulations described in subsection
(b).
    (b) Content of Proposed Regulations.--The proposed regulations
shall be based on the recommendations provided by the Advisory Panel,
and shall--
            (1) permit longitudinal analysis of child-specific
        outcomes, including analysis of entry and exit cohort data for
        children in and emancipated from foster care;
            (2) permit AFCARS to be integrated with the planned
        National Youth in Transition Database; and
            (3) contain such other rules as may be necessary to ensure
        that the revised AFCARS can perform the functions described in
        section 3(b).
    (c) Final Regulations.--Not later than 6 months after the notice
required by subsection (a) is published, the Secretary of Health and
Human Services shall publish final regulations to revise AFCARS in the
manner described in this section.

Summary: Accountability in Foster Care Act - Directs the Secretary of Health and Human Services to establish an Advisory Panel on the Adoption and Foster Care Analysis and Reporting System (AFCARS) to revise and monitor the data collection, analysis, and reporting system designed to be used to assess and improve state performance in operating child protection and child welfare programs . Directs the Secretary to publish notice of proposed regulations, based on Advisory Panel recommendations, and final regulations to revise AFCARS. Requires such regulations to: (1) permit longitudinal analysis of child-specific outcomes, including analysis of entry and exit cohort data for children in and emancipated from foster care. (2) permit AFCARS to be integrated with the planned National Youth in Transition Database. And (3) contain any other rules necessary to ensure that the revised AFCARS can perform specified functions.

To strengthen the accountability of the child welfare system in its mandate to ensure the safety, permanence, and well-being of children who are victims of abuse and neglect.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Generating Antibiotic Incentives Now
Act of 2011''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Extension of exclusivity period for drugs.
Sec. 4. Additional extension of exclusivity period for qualified
                            infectious disease products for which a
                            companion diagnostic test is cleared or
                            approved.
Sec. 5. Priority review.
Sec. 6. Fast track product.
Sec. 7. Study on incentives for qualified infectious disease biological
                            products.
Sec. 8. Clinical trials.

SEC. 3. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act is
amended by inserting after section 505D (21 U.S.C. 355e) the following:

``SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW QUALIFIED
              INFECTIOUS DISEASE PRODUCTS.

    ``(a) Extension.--If, prior to approval of a drug pursuant to an
application submitted under section 505(b), the Secretary determines
that the drug is a qualified infectious disease product, then the four-
and five-year periods described in subsections (c)(3)(E)(ii) and
(j)(5)(F)(ii) of section 505, the three-year periods described in
clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and
(iv) of subsection (j)(5)(F) of section 505, or the seven-year period
described in section 527, as applicable, shall be extended by five
years.
    ``(b) Relation to Pediatric Exclusivity.--Any extension under
subsection (a) of a period shall be in addition to any extension of the
period under section 505A with respect to the drug.
    ``(c) Limitations.--Subsection (a) does not apply to the approval
of--
            ``(1) a supplement to an application under section 505(b)
        for any qualified infectious disease product for which an
        extension described in subsection (a) is in effect or has
        expired; or
            ``(2) a subsequent application filed by the same sponsor or
        manufacturer of a qualified infectious disease product
        described in paragraph (1) (or a licensor, predecessor in
        interest, or other related entity) for--
                    ``(A) a change (not including a modification to the
                structure of the qualified infectious disease product)
                that results in a new indication, route of
                administration, dosing schedule, dosage form, delivery
                system, delivery device, or strength; or
                    ``(B) a modification to the structure of the
                qualified infectious disease product that does not
                result in a change in safety or effectiveness.
    ``(d) Determination.--The manufacturer or sponsor of a drug may
request the Secretary to designate a drug as a qualified infectious
disease product. Such a request for designation shall be made at least
45 days before the submission of an application under section 505(b)
for such drug. The Secretary shall, not later than 30 days after the
submission of such request, determine whether the drug is a qualified
infectious disease product.
    ``(e) Regulations.--The Secretary shall promulgate regulations for
carrying out this section. The Secretary shall promulgate the initial
regulations for carrying out this section not later than 12 months
after the date of the enactment of this section.
    ``(f) Definitions.--In this section:
            ``(1) Qualified infectious disease product.--The term
        `qualified infectious disease product' means an antibiotic drug
        for treating, detecting, preventing, or identifying a
        qualifying pathogen.
            ``(2) Qualifying pathogen.--The term `qualifying pathogen'
        means--
                    ``(A) resistant gram positive pathogens, including
                methicillin-resistant Staphylococcus aureus (MRSA),
                vancomycin-resistant Staphylococcus aureus (VRSA), and
                vancomycin-resistant enterococcus (VRE);
                    ``(B) multi-drug resistant gram negative bacteria,
                including Acinetobacter, Klebsiella, Pseudomonas, and
                E. coli species;
                    ``(C) multi-drug resistant tuberculosis; or
                    ``(D) any other infectious pathogen identified for
                purposes of this section by the Secretary.''.
    (b) Application.--Section 505E of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), applies only with respect to
a drug that is first approved under section 505(c) of such Act (21
U.S.C. 355(c)) on or after the date of the enactment of this Act.

SEC. 4. ADDITIONAL EXTENSION OF EXCLUSIVITY PERIOD FOR QUALIFIED
              INFECTIOUS DISEASE PRODUCTS FOR WHICH A COMPANION
              DIAGNOSTIC TEST IS CLEARED OR APPROVED.

    The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.),
as amended by section 3, is further amended by inserting after section
505E the following:

``SEC. 505E-1. ADDITIONAL EXTENSION OF EXCLUSIVITY FOR QUALIFIED
              INFECTIOUS DISEASE PRODUCTS FOR WHICH A COMPANION
              DIAGNOSTIC TEST IS CLEARED OR APPROVED.

    ``(a) In General.--If the sponsor or manufacturer of a qualified
infectious disease product identifies in accordance with subsection (b)
a companion diagnostic test described in subsection (c), any period
extended under section 505E(a) with respect to such product shall be
further extended by 6 months.
    ``(b) Identification Requirements.--For purposes of subsection (a),
the identification of a companion diagnostic test shall--
            ``(1) be made in such manner as the Secretary may require;
        and
            ``(2) occur before the expiration of the period to be
        extended under subsection (a), not counting any extension to
        such period under section 505E(a) or 505A.
    ``(c) Companion Diagnostic Test.--For purposes of subsection (a), a
device is a companion diagnostic test with respect to a qualified
infectious disease product if each of the following is met:
            ``(1) The device is determined by the Secretary under
        subsection (f) to be a test for diagnosis of a qualifying
        pathogen.
            ``(2) The qualified infectious disease product has been
        determined under section 505E(d) to be for treating, detecting,
        preventing, or identifying such qualifying pathogen.
            ``(3) The device is cleared under section 510(k) or
        approved under section 515.
            ``(4) The sponsor or manufacturer, as applicable, of the
        qualified infectious disease product has the exclusive rights
        to submit an identification under subsection (a) with respect
        to the device.
    ``(d) Relation to Pediatric Exclusivity.--Any extension under
subsection (a) of a period with respect to a qualified infectious
disease product shall be in addition to any extension of the period
under section 505A of this Act with respect to the product.
    ``(e) Limitations.--After the extension of any period under
subsection (a) with respect to a qualified infectious disease product
pursuant to the identification of a device as a companion diagnostic
test, subsection (a) does not authorize--
            ``(1) any subsequent extension with respect to such
        product; or
            ``(2) any extension with respect to any other product
        pursuant to identification of such device.
    ``(f) Determination.--The sponsor or manufacturer of a drug may
request the Secretary to determine that a device is a test for
diagnosis of a qualifying pathogen. Such a request shall be made at
least 45 days before the submission of a notification under section
510(k) or an application under section 515 for such device. The
Secretary shall, not later than 30 days after the submission of such
request, determine whether the device is a test for diagnosis of a
qualifying pathogen.
    ``(g) Definitions.--In this section:
            ``(1) The term `qualified infectious disease product' means
        a drug that is determined to be a qualified infectious disease
        product under section 505E.
            ``(2) The term `qualifying pathogen' has the meaning given
        to such term in section 505E.''.

SEC. 5. PRIORITY REVIEW.

    (a) Amendment.--Chapter V of the Federal Food, Drug, and Cosmetic
Act is amended by inserting after section 524 (21 U.S.C. 360n) the
following:

``SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS.

    ``(a) In General.--If the Secretary makes a determination under
section 505E(c) that a drug is a qualified infectious disease product,
then the Secretary shall give priority review to any application
submitted for approval for such drug under section 505(b).
    ``(b) Definition.--In this section, the term `priority review',
with respect to an application described in subsection (a), means
review and action by the Secretary on such application not later than 6
months after receipt by the Secretary of such application.''.
    (b) Application.--Section 524A of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), applies only with respect to
an application that is submitted under section 505(b) (21 U.S.C.
355(b)) on or after the date of the enactment of this Act.

SEC. 6. FAST TRACK PRODUCT.

    Paragraph (1) of section 506(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356(a)) is amended by inserting after ``if it
is intended for the treatment of a serious or life-threatening
condition and it demonstrates the potential to address unmet medical
needs for such a condition'' the following: ``or if the Secretary
determines under section 505E that the drug is a qualified infectious
disease product''.

SEC. 7. STUDY ON INCENTIVES FOR QUALIFIED INFECTIOUS DISEASE BIOLOGICAL
              PRODUCTS.

    (a) In General.--The Comptroller General of the United States
shall--
            (1) conduct a study on the need for incentives to encourage
        the research, development, and marketing of qualified
        infectious disease biological products; and
            (2) not later than 1 year after the date of the enactment
        of this Act, submit a report to the Congress on the results of
        such study, including any recommendations of the Comptroller
        General on appropriate incentives for addressing such need.
    (b) Definitions.--In this section:
            (1) The term ``biological product'' has the meaning given
        to such term in section 351 of the Public Health Service Act
        (42 U.S.C. 262).
            (2) The term ``qualified infectious disease biological
        product'' means a biological product for treating, detecting,
        preventing, or identifying a qualifying pathogen.
            (3) The term ``qualifying pathogen'' has the meaning given
        to such term in section 505E of the Federal Food, Drug, and
        Cosmetic Act, as added by section 3 of this Act.

SEC. 8. CLINICAL TRIALS.

    (a) Review and Revision of Guidelines.--
            (1) In general.--Not later than 1 year after the date of
        the enactment of this Act, and not later than 4 years
        thereafter, the Secretary shall--
                    (A) review the guidelines of the Food and Drug
                Administration for the conduct of clinical trials with
                respect to antibiotic drugs; and
                    (B) as appropriate, revise such guidelines to
                reflect developments in scientific and medical
                information and technology and to ensure clarity
                regarding the procedures and requirements for approval
                of an antibiotic drug under chapter V of the Federal
                Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.).
            (2) Issues for review.--At a minimum, the review under
        paragraph (1) shall address the appropriate animal models of
        infection, in vitro techniques, valid micro-biological
        surrogate markers, the use of non-inferiority versus
        superiority trials, and appropriate delta values for non-
        inferiority trials.
            (3) Rule of construction.--Except to the extent to which
        the Secretary of Health and Human Services makes revisions
        under paragraph (1)(B), nothing in this section shall be
        construed to repeal or otherwise affect the guidelines of the
        Food and Drug Administration.
    (b) Recommendations for Investigations.--
            (1) Request.--The sponsor of a drug intended to be used to
        treat, detect, prevent, or identify a qualifying pathogen may
        request that the Secretary provide written recommendations for
        nonclinical and clinical investigations which may be conducted
        with the drug before it may be approved for such use under
        section 505 of the Federal Food, Drug, and Cosmetic Act (21
        U.S.C. 355).
            (2) Recommendations.--If the Secretary has reason to
        believe that a drug for which a request is made under this
        subsection is a qualified infections disease product, the
        Secretary shall provide the person making the request written
        recommendations for the nonclinical and clinical investigations
        which the Secretary believes, on the basis of information
        available to the Secretary at the time of the request, would be
        necessary for approval under section 505 of the Federal Food,
        Drug, and Cosmetic Act (21 U.S.C. 355) of such drug for the use
        described in paragraph (1).
    (c) Definitions.--In this section:
            (1) The term ``drug'' has the meaning given to such term in
        section 201 of the Federal Food, Drug, and Cosmetic Act (21
        U.S.C. 321).
            (2) The term ``qualifying pathogen'' has the meaning given
        to such term in section 505E of the Federal Food, Drug, and
        Cosmetic Act, as added by section 3 of this Act.
            (3) The term ``Secretary'' means the Secretary of Health
        and Human Services, acting through the Commissioner of Food and
        Drugs.

Summary: Generating Antibiotic Incentives Now Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to extend the exclusivity period for a new prescription drug by five years for a drug that the Secretary of Health and Human Services (HHS) determines to be a qualified infectious disease product. Defines qualified infectious disease product to mean an antibiotic drug for treating, detecting, preventing, or identifying a qualifying pathogen . Excludes drugs that are: (1) a supplement to a new drug application for which an extension is in effect or has expired. Or (2) a subsequent application for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength, or a modification to the structure of the product that does not result in a change in safety or effectiveness. Extends such period of exclusivity an additional six months for a sponsor or manufacturer of a qualified infectious disease product that identifies a companion diagnostic test. Requires the Secretary to give priority review to any drug determined to be a qualified infectious disease product. Includes qualified infectious disease products as fast track products for which the Secretary shall facilitate development and expedite review. Directs the Comptroller General to study the need for incentives to encourage the research, development, and marketing of qualified infectious disease biological products. Requires the Secretary to: (1) review Food and Drug Administration (FDA) guidelines for clinical trials of antibiotic drugs. And (2) revise such guidelines, as appropriate, to reflect developments in scientific and medical information and technology and to ensure clarity regarding the procedures and requirements for approval of an antibiotic drug.

A bill to provide incentives for the development of qualified infectious disease products.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Occupational Safety and Health-
Fairness Act of 2003''.

SEC. 2. CONTESTING CITATIONS UNDER THE OCCUPATIONAL SAFETY AND HEALTH
              ACT.

    (a) Citation.--The second sentence of section 10(a) of the
Occupational Safety and Health Act of 1970 (29 U.S.C. 659(a)) is
amended by inserting ``(unless such failure results from mistake,
inadvertence, surprise, or excusable neglect)'' after ``assessment of
penalty''.
    (b) Failure to Correct.--The second sentence of section 10(b) of
the Occupational Safety and Health Act of 1970 (29 U.S.C. 659(b)) is
amended by inserting ``(unless such failure results from mistake,
inadvertence, surprise, or excusable neglect)'' after ``assessment of
penalty''.

SEC. 3. WILLFUL VIOLATIONS.

    Section 17(a) of the Occupational Safety and Health Act of 1970 (29
U.S.C. 666(a)) is amended by inserting at the end, ``A violation is
willful only if the employer (1) knew that the alleged condition
violated a standard, rule, order or regulation and, without a good
faith belief in the legality in its conduct, knowingly disregarded the
requirement of the standard, rule, order, or regulation, or (2) knew
that employees were, or that it was reasonably predictable that
employees would be, exposed to a hazard causing or likely to cause
death or serious physical injury and recklessly disregarded the
exposure of employees to that hazard.''.

SEC. 4. FAIRNESS OF PENALTY ASSESSMENT

    Section 17(j) of the Occupational Safety and Health Act of 1970 (29
U.S.C. 666(j)) is amended--
            (1) by inserting the words, ``and de novo'' after the word
        ``due''; and
            (2) striking all after the word ``consideration'' and
        inserting in lieu thereof: ``to the evidence of the
        appropriateness of the penalty with respect to at least the
        following factors:
            ``(1) the size and financial condition of the business of
        the employer;
            ``(2) the gravity of the violation, considering the
        probability of harm, the nature and extent of the harm, the
        number of affected employees, and other relevant factors;
            ``(3) the good faith of the employer, including the
        employer's good faith efforts to comply or abate;
            ``(4) the history and recentness of substantially similar
        previous violations of the cited employer at the same
        nonconstruction worksite and at construction worksites within
        the same State; and
            ``(5) the degree of responsibility or culpability for the
        violation of the employer, the employees, and/or other
        persons.''.

SEC. 5. OCCUPATIONAL SAFETY AND HEALTH REVIEW COMMISSION.

    (a) Amendments.--Section 12 of the Occupational Safety and Health
Act of 1970 (29 U.S.C. 661) is amended as follows:
            (1) In subsection (a), by striking the word ``three'' and
        inserting in lieu thereof, the word ``five;'' and inserting
        before the word ``training'' the word ``legal''.
            (2) In subsection (b) by striking all after the words
        ``except that'' and inserting in lieu thereof, ``the President
        may extend the term of a member to allow a continuation in
        service at the pleasure of the President after the expiration
        of that member's term until a successor nominated by the
        President has been confirmed to serve. Any vacancy caused by
        the death, resignation, or removal of a member before the
        expiration of a term, for which he or she was appointed shall
        be filled only for the remainder of such expired term. A member
        of the Commission may be removed by the President for
        inefficiency, neglect of duty, or malfeasance in office.
            (3) Subsection (f) is amended to read as follows:
    ``(f) The Chairman of the Commission is authorized to delegate to
any panel of three or more members any or all of the powers of the
Commission. For the purpose of carrying out its functions under this
chapter, 3 members of the Commission shall constitute a quorum, except
that 2 members shall constitute a quorum for any sub-panel designated
by the Chairman under this subsection.''.
    (b) New Positions.--Of the two vacancies for membership on the
Commission created by this section, one shall be filled by the
President for a term expiring on April 27, 2006, and the other shall be
filled by the President for a term expiring on April 27, 2008.

SEC. 6. AWARD OF ATTORNEY'S FEES AND COSTS.

    The Occupational Safety and Health Act of 1970 (29 U.S.C. 651 and
following) is amended by redesignating section 32 through 34 as 33
through 35 and inserting the following new section after section 31:

``SEC. 32. AWARD OF ATTORNEYS' FEES AND COSTS.

    ``(a) Administrative Proceedings.--An employer who--
            ``(1) is the prevailing party in any adversary adjudication
        instituted under this Act, and
            ``(2) had not more than 100 employees and a net worth of
        not more than $1,500,000 at the time of the adversary
        adjudication was initiated,
shall be awarded fees and other expenses as a prevailing party under
section 504 of title 5, United States Code, in accordance with the
provisions of that section, but without regard to whether the position
of the Secretary was substantially justified or special circumstances
make an award unjust. For purposes of this section the term `adversary
adjudication' has the meaning given that term in section 504(b)(1)(C)
of title 5, United States Code.
    ``(b) Proceedings.-- An employer who--
            ``(1) is the prevailing party in any proceeding for
        judicial review of any action instituted under this Act, and
            ``(2) had not more than 100 employees and a net worth of
        not more than $1,500,000 at the time the action addressed under
        subsection (1) was filed,
shall be awarded fees and other expenses as a prevailing party under
section 2412(d) of title 28, United States Code, in accordance with the
provisions of that section, but without regard to whether the position
of the United States was substantially justified or special
circumstances make an award unjust. Any appeal of a determination of
fees pursuant to subsection (a) of this subsection shall be determined
without regard to whether the position of the United States was
substantially justified or special circumstances make an award unjust.
    ``(c) Applicability.--
            ``(1) Commission proceedings.--Subsection (a) of this
        section applies to proceedings commenced on or after the date
        of enactment of this Act.
            ``(2) Court proceedings.--Subsection (b) of this section
        applies to proceedings for judicial review commenced on or
        after the date of enactment of this Act.''.

SEC. 7. INDEPENDENT REVIEW.

    Section 11(a) of the Occupational Safety and Health Act of 1970 (29
U.S.C. 660) is amended by adding the following at the end thereof:
``The conclusions of the Commission with respect to all questions of
law shall be given deference if reasonable.''.

Summary: Occupational Safety and Health Fairness Act of 2003 - Amends the Occupational Safety and Health Act of 1970 (OSHA) to revise requirements relating to enforcing, contesting, reviewing, and adjudicating citations, failures to correct violations, and assessments of penalties. Exempts employers from a 15-day deadline for notifying the Secretary of Labor of their intent to contest OSHA citations, notices of uncorrected violations, and proposed penalties, if their failure to meet such deadline results from mistake, inadvertence, surprise, or excusable neglect. Limits what may be considered willful violations under OSHA. Requires the Occupational Safety and Health Review Commission (OSHRC) to give de novo consideration to evidence of the penalty's appropriateness with respect to these factors: (1) size and financial condition of the business of the employer. (2) gravity of the violation, considering probability of harm, nature and extent of the harm, number of affected employees, and other relevant factors, (3) employer's good faith, including efforts to comply or abate. (4) history and recentness of substantially similar previous violations of the cited employer at the same nonconstruction worksite and construction worksites in the same State. And (5) the employer's, employees', or other persons' degree of responsibility or culpability for the violation. Increases OSHRC membership from three to five. Awards attorney's fees and costs to a prevailing employer in an administrative adversary adjudication, or a judicial review of an action, instituted under OSHA, if at the time such adjudication was initiated or such action filed the employer had not more than: (1) 100 employees. And (2) $1,500,000 net worth. Revises judicial review provisions to require deference to be given to reasonable OSHRC conclusions with respect to all questions of law.

To amend the Occupational Safety and Health Act of 1970 to provide for adjudicative improvement, and for other purposes.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Safety and Fuel Economy (SAFE)
Act''.

SEC. 2. FINDINGS.

    The Congress finds and declares the following:
            (1) Automobile fuel economy standards have played an
        important role in mitigating the increased consumption of
        gasoline and have resulted in lower fuel costs to consumers.
            (2) Such standards and the successful response of
        automobile manufacturers to those standards have been very
        effective in increasing automobile fuel efficiency, resulting
        in a near doubling of the passenger automobile fleet fuel
        economy between 1975 and the present.
            (3) In recent years, the average automobile fuel economy of
        the fleets of many automobile manufacturers has actually
        declined, while the size and horsepower of the fleets have
        increased. Overall, automobile and light truck average fuel
        economy in 2000 was at its lowest in 20 years.
            (4) Several Government studies agree that increased fuel
        efficiency is possible utilizing currently available technology
        and without significant changes in the size, mix, or
        performance of the fleet of automobiles. In addition, the
        safety of the current fleet of automobiles can be maintained
        and potentially improved through improved safety features.
            (5) With appropriate lead time, and by utilizing technology
        currently in production, passenger automobile average fuel
        economy of between 38 and 45 miles per gallon has been
        estimated by various experts to be feasible without significant
        changes in automobile size or performance. When technology
        currently in development becomes available, even higher levels
        of average fuel economy are possible.
            (6) Improved automobile average fuel economy standards can
        reduce carbon dioxide emissions, improve air quality, and
        potentially mitigate against global warming.

SEC. 3. IMPROVING CRASH SAFETY OF AUTOMOBILES AND LIGHT TRUCKS IN
              COLLISIONS.

    (a) In General.--Subchapter II of chapter 301 of title 49, United
States Code, is amended by adding at the end the following:
``Sec. 30128. Crash safety of automobiles and light trucks in
              collisions
    ``(a) Motor Vehicle Safety Standard.--
            ``(1) Notice of proposed rulemaking.--Not later than June
        1, 2002, the Secretary of Transportation shall issue a notice
        of proposed rulemaking to prescribe a new Federal motor vehicle
        safety standard to improve the crash safety of automobiles and
        light trucks in collisions.
            ``(2) CRAGG index.--The new standard prescribed under this
        subsection shall include a Crash Aggressivity index (in this
        section referred to as a `CRAGG index') that--
                    ``(A) measures the aggressivity of a motor vehicle;
                    ``(B) takes into account the stiffness, structure
                height, and mass of a vehicle; and
                    ``(C) substantially improves the present crash
                safety of automobiles and light trucks by reducing the
                aggressivity of such vehicles.
            ``(3) Final rule.--Notwithstanding any other provision of
        law, the Secretary shall complete a rulemaking to prescribe
        such a standard by issuing, not later than June 1, 2003, a
        final rule with any provision the Secretary considers
        appropriate, consistent with this subsection and the
        requirements of section 30111 of title 49, United States Code.
            ``(4) Effective date.--The Secretary shall specify in the
        final rule issued under this subsection that the rule--
                    ``(A) shall become effective in phases as rapidly
                as practicable, beginning September 1, 2005; and
                    ``(B) shall be fully effective for all vehicles
                identified in section 30127(b) of title 49, United
                States Code, that are manufactured on and after
                September 1, 2009.
    ``(b) Disclosure of CRAGG Index Ratings to Purchasers.--
            ``(1) Disclosure by manufacturers.--The Secretary of
        Transportation shall issue regulations that require that motor
        vehicle manufacturers--
                    ``(A) report CRAGG index ratings for each model
                year after model year 2005;
                    ``(B) submit the first such report by no later than
                August 1, 2005, and submit such reports by August 1 of
                each year thereafter; and
                    ``(C) conspicuously post on each new motor vehicle
                at the point of sale the CRAGG index rating for the
                vehicle, beginning September 1, 2005.
            ``(2) Disclosure by secretary.--The Secretary shall also
        post on the Department of Transportation's Internet website,
        beginning September 1, 2005--
                    ``(A) comparative CRAGG index ratings, by make and
                model; and
                    ``(B) an identification of the 10 motor vehicles
                with the greatest aggressivity, by CRAGG index rating,
                each year.
    ``(c) Annual Report.--The Secretary of Transportation shall
annually report to the Congress on January 1 of each year beginning in
2004 on the progress made in improving the crash safety of automobiles
and light trucks in collisions. Such report shall address the
comparative improvement in the aggressivity of new vehicles as measured
by the CRAGG index and the number of fatalities caused by the
aggressivity of light trucks and sport utility vehicles in collisions
with other vehicles.
    ``(d) Revision of Standard.--On September 1, 2007, the Secretary of
Transportation shall issue an advanced notice of proposed rulemaking to
determine if substantial improvement has been made in the crash safety
of automobiles and light trucks that are subject to the Federal motor
vehicle safety standard prescribed under subsection (a). If substantial
improvement has not been made, the Secretary shall issue a notice of
proposed rulemaking by March 1, 2008, to revise such standard to
further increase crash comparability. If initiated, the Secretary shall
complete the rulemaking required by this subsection by issuing a new
final rule not later than March 1, 2009. The Secretary shall specify in
the rule that the rule shall become effective in phases as rapidly as
practicable, beginning September 1, 2010. The rule shall become fully
effective for all vehicles identified in section 30127(b), title 49,
United States Code, that are manufactured on and after September 1,
2012.
    ``(e) Phased-In Requirements.--
            ``(1) In general.--If the Secretary of Transportation fails
        to meet any of the deadlines in subsections (a) through (d) of
        this section with respect to any motor vehicle, motor vehicles
        with respect to which such deadline applied having a gross
        vehicle weight rating less than 10,000 pounds that are
        manufactured by each manufacturer must satisfy the requirements
        described in paragraph (2) in accordance with the following
        phase-in schedule:
                    ``(A) 20 percent of such vehicles manufactured by a
                manufacturer in the first year after the date the
                deadline is not met must satisfy such requirements.
                    ``(B) 40 percent of such vehicles manufactured by a
                manufacturer in the second year after the date the
                deadline is not met must satisfy such requirements.
                    ``(C) 60 percent of such vehicles manufactured by a
                manufacturer in the third year after the date the
                deadline is not met must satisfy such requirements.
                    ``(D) 80 percent of such vehicles manufactured by a
                manufacturer in the fourth year after deadline is not
                met must satisfy such requirements.
                    ``(E) All such vehicles manufactured by a
                manufacturer after the fourth year after the date the
                deadline is not met must satisfy such requirements.
            ``(2) Requirements.--The requirements referred to in
        paragraph (1) are the following, in the frontal barrier crash
        test defined in section 571.208 S5.1 of title 49, Code of
        Federal Regulations, conducted with a load cell barrier:
                    ``(A) The height of the center of force as
                determined by a 30 mile per hour crash into a load cell
                barrier shall not be greater than 22 inches (55
                centimeters).
                    ``(B) For any vehicle with a curb weight greater
                than 3,500 pounds, the dynamic stiffness shall not be
                greater than the number determined by multiplying--
                            ``(i) 50,000 pounds; by
                            ``(ii) the number determined by dividing--
                                    ``(I) 33,000; by
                                    ``(II) the number determined by
                                subtracting the weight of the vehicle
                                (in pounds) from 20,000.
    ``(f) Advisory Committees.--The Secretary of Transportation shall
ensure that--
            ``(1) any Federal advisory committee, task force, or other
        entity concerned with vehicle compatibility includes a balance
        of representatives from consumer and safety organizations,
        insurers, manufacturers, and suppliers; and
            ``(2) such consumer and safety organization representatives
        are selected from among organizations that do not receive any
        significant funding from motor vehicle manufacturers and their
        affiliates.
    ``(g) Definitions.--
            ``(1) Automobile; light truck.--Each of the terms
        `automobile' and `light truck' has the meaning set forth in
        section 32901 of this title.
            ``(2) Aggressivity.--The term `aggressivity' means the
        degree to which the front of a motor vehicle, in a collision
        with another motor vehicle--
                    ``(A) inflicts damage to the other motor vehicle;
                and
                    ``(B) causes injury to the occupants of the other
                motor vehicle.''.
    (b) Clerical Amendment.--The table of sections at the beginning of
chapter 301 of title 49, United States Code, is amended by inserting
after the item relating to section 30127 the following:

``30128. Crash safety of automobiles and light trucks in collisions.''.

SEC. 4. INCREASED AVERAGE FUEL ECONOMY STANDARDS FOR PASSENGER
              AUTOMOBILES AND LIGHT TRUCKS.

    (a) Increased Standards.--Section 32902 of title 49, United States
Code, is amended--
            (1) in subsection (a)--
                    (A) by striking ``Non-Passenger Automobiles.--''
                and inserting ``Prescription of Standards by
                Regulation.--''; and
                    (B) by striking ``(except passenger automobiles)''
                and inserting ``(except passenger automobiles and light
                trucks)''; and
            (2) by amending subsection (b) to read as follows:
    ``(b) Standards for Passenger Automobiles and Light Trucks.--
            ``(1) Passenger automobiles, generally.--The average fuel
        economy standard for passenger automobiles manufactured by a
        manufacturer--
                    ``(A) after model year 2003 shall be 30.0 miles per
                gallon; and
                    ``(B) after model year 2005 shall be 32.5 miles per
                gallon.
            ``(2) Light trucks.--The average fuel economy standard for
        light trucks manufactured by a manufacturer--
                    ``(A) after model year 2003 shall be 23.0 miles per
                gallon; and
                    ``(B) after model year 2005 shall be 25.5 miles per
                gallon.
            ``(3) Combined standard.--The average fuel economy standard
        for the combination of passenger automobiles and light trucks
        manufactured by a manufacturer--
                    ``(A) after model year 2007 shall be 32.0 miles per
                gallon;
                    ``(B) after model year 2009 shall be 36.0 miles per
                gallon; and
                    ``(C) after model year 2011 shall be 40.0 miles per
                gallon.''.
    (b) Definition of Light Truck.--
            (1) In general.--Section 32901(a) of title 49, United
        States Code, is amended by adding at the end the following:
            ``(17) `light truck' means an automobile that the Secretary
        decides by regulation--
                    ``(A) is manufactured primarily for transporting
                not more than 10 individuals;
                    ``(B) is rated at not more than 8,500 pounds gross
                vehicle weight; and
                    ``(C) is not a passenger automobile.''.
            (2) Deadline for regulations.--The Secretary of
        Transportation--
                    (A) shall issue proposed regulations implementing
                the amendment made by this subsection by not later than
                6 months after the date of the enactment of this Act;
                and
                    (B) shall issue final regulations implementing such
                amendment by not later than one year after the date of
                the enactment of this Act.
    (c) Conforming Amendments.--(1) Section 32902(c) of title 49,
United States Code, is amended--
            (A) in paragraph (1), by striking ``the standard'' and
        inserting ``a standard''; and
            (B) in paragraph (2), by striking ``increases the standard
        above 27.5 miles per gallon, or decreases the standard below
        26.0 miles per gallon,'' and inserting ``increases the standard
        above the standard that would otherwise apply under subsection
        (b), or decreases the standard by more than 1.5 miles per
        gallon below the standard that would otherwise apply under
        subsection (b),''.
    (d) Application.--The amendments made by this section shall apply
beginning on January 1, 2006.
    (e) Applicability of Existing Standards.--This section does not
affect the application of section 32902 of title 49, United States
Code, to passenger automobiles and light trucks manufactured before
model year 2007.

SEC. 5. FUEL ECONOMY STANDARDS FOR AUTOMOBILES UP TO 10,000 POUNDS
              GROSS VEHICLE WEIGHT.

    (a) Vehicles Defined as Automobiles.--Section 32901(a)(3) of title
49, United States Code, is amended by striking ``6,000'' each place it
appears and inserting ``8,500''.
    (b) Application Date.--The amendment made by subsection (a) shall
apply beginning on January 1, 2006.

SEC. 6. IMPROVEMENT OF CALCULATION OF AVERAGE FUEL ECONOMY.

    (a) In General.--Section 32904(a) of title 49, United States Code,
is amended--
            (1) by inserting ``(1)'' before the first sentence;
            (2) in paragraph (1) (as so designated), in the second
        sentence by inserting ``and subject to paragraph (2) of this
        subsection,'' after ``of this title,''; and
            (3) by adding at the end the following:
    ``(2) Calculations and testing procedures prescribed by the
Secretary under paragraph (1) shall ensure that average fuel economy
calculated under this subsection--
            ``(A) reflects, and is determined under conditions that
        include, actual driving conditions; and
            ``(B) is not an optimized number that results solely from
        tests performed under laboratory conditions.''.
    (b) Application.--The amendment made by subsection (a) shall apply
with respect to automobiles manufactured after model year 2005.
    (c) Regulations.--The Administrator of the Environmental Protection
Agency shall issue regulations that implement the amendments made by
subsection (a) by not later than December 31, 2002.

Summary: Safety and Fuel Economy (SAFE) Act - Amends Federal transportation law to direct the Secretary of Transportation to issue a notice of proposed rulemaking to prescribe a new Federal motor vehicle safety standard to improve the crash safety of automobiles and light trucks in collisions. Directs the Secretary to issue regulations that require motor vehicle manufacturers to disclose CRAGG index ratings to purchasers of new motor vehicles after model year 2005. Establishes the CRAGG index as one that: (1) measures a motor vehicle's aggressivity, (2) takes into account its stiffness, structure height, and mass. And (3) substantially improves the present crash safety of automobiles and light trucks by reducing their aggressivity. Defines aggressivity as the degree to which the front of a motor vehicle in a collision with another motor vehicle inflicts damage to the other vehicle and causes injury to its occupants. Sets forth average fuel economy standards for passenger automobiles and light trucks manufactured after model years 2003, 2005, 2007, 2009, and 2011.

To amend title 49, United States Code, to improve highway safety by requiring reductions in the aggressivity of light trucks; to extend average fuel economy standards to all light trucks up to 10,000 pounds gross vehicle weight; to require phased increases in the average fuel economy standards for passenger automobiles and light trucks; to improve the accuracy of average fuel economy testing and public information regarding average fuel economy, and for other purposes.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Securing Opioids and Unused
Narcotics with Deliberate Disposal and Packaging Act of 2018'' or the
``SOUND Disposal and Packaging Act''.

SEC. 2. IMPROVED TECHNOLOGIES, CONTROLS, OR MEASURES WITH RESPECT TO
              THE PACKAGING OR DISPOSAL OF CERTAIN DRUGS.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act is amended by inserting after section 505-1 (21 U.S.C. 355-1) the
following new section:

``SEC. 505-2. SAFETY-ENHANCING PACKAGING AND DISPOSAL FEATURES.

    ``(a) Orders.--
            ``(1) In general.--The Secretary may issue an order
        requiring the holder of a covered application to implement or
        modify one or more technologies, controls, or measures with
        respect to the packaging or disposal of one or more drugs
        identified in the covered application, if the Secretary
        determines such technologies, controls, or measures to be
        appropriate to help mitigate the risk of abuse or misuse of
        such drug or drugs, which may include by reducing the
        availability of unused drugs.
            ``(2) Prior consultation.--The Secretary may not issue an
        order under paragraph (1) unless the Secretary has consulted
        with relevant stakeholders, through a public meeting, workshop,
        or otherwise, about matters that are relevant to the subject of
        the order.
            ``(3) Assuring access and minimizing burden.--Technologies,
        controls, or measures required under paragraph (1) shall--
                    ``(A) be commensurate with the specific risk of
                abuse or misuse of the drug listed in the covered
                application;
                    ``(B) considering such risk, not be unduly
                burdensome on patient access to the drug, considering
                in particular any available evidence regarding the
                expected or demonstrated public health impact of such
                technologies, controls, or measures; and
                    ``(C) reduce the risk of abuse or misuse of such
                drug.
            ``(4) Order contents.--An order issued under paragraph (1)
        may--
                    ``(A) provide for a range of options for
                implementing or modifying the technologies, controls,
                or measures required to be implemented by such order;
                and
                    ``(B) incorporate by reference standards regarding
                packaging or disposal set forth in an official
                compendium, established by a nationally or
                internationally recognized standard development
                organization, or described on the public website of the
                Food and Drug Administration, so long as the order
                includes the rationale for incorporation of such
                standard.
            ``(5) Orders applicable to drug class.--When a concern
        about the risk of abuse or misuse of a drug relates to a
        pharmacological class, the Secretary may, after consultation
        with relevant stakeholders, issue an order under paragraph (1)
        which applies to the pharmacological class.
    ``(b) Compliance.--The holder of a covered application shall--
            ``(1) submit a supplement containing proposed changes to
        the covered application to comply with an order issued under
        subsection (a) not later than--
                    ``(A) 180 calendar days after the date on which the
                order is issued; or
                    ``(B)(i) such longer time period as specified by
                the Secretary in such order; or
                    ``(ii) if a request for an alternative date is
                submitted by the holder of such application not later
                than 60 calendar days after the date on which such
                order is issued--
                            ``(I) such requested alternative date if
                        agreed to by the Secretary; or
                            ``(II) another date as specified by the
                        Secretary; and
            ``(2) implement the changes approved pursuant to such
        supplement not later than the later of--
                    ``(A) 90 calendar days after the date on which the
                supplement is approved; or
                    ``(B) the end of such longer period as is--
                            ``(i) determined to be appropriate by the
                        Secretary; or
                            ``(ii) approved by the Secretary pursuant
                        to a request by the holder of the covered
                        application that explains why such longer
                        period is needed, including to satisfy any
                        other applicable Federal statutory or
                        regulatory requirements.
    ``(c) Alternative Measures.--The holder of the covered application
may propose, and the Secretary shall approve, technologies, controls,
or measures regarding packaging, storage, or disposal other than those
specified in the applicable order issued under subsection (a), if such
technologies, controls, or measures are supported by data and
information demonstrating that such alternative technologies, controls,
or measures can be expected to mitigate the risk of abuse or misuse of
the drug or drugs involved, including by reducing the availability of
unused drugs, to at least the same extent as the technologies,
controls, or measures specified in such order.
    ``(d) Dispute Resolution.--If a dispute arises in connection with a
supplement submitted under subsection (b), the holder of the covered
application may appeal a determination made with respect to such
supplement using applicable dispute resolution procedures specified by
the Secretary in regulations or guidance.
    ``(e) Definitions.--In this section--
            ``(1) the term `covered application' means an application
        submitted under subsection (b) or (j) of section 505 for
        approval under such section or an application submitted under
        section 351 of Public Health Service Act for approval under
        such section, with respect to a drug that is or contains an
        opioid for which a listing in schedule II or III (on a
        temporary or permanent basis) is in effect under section 202 of
        the Controlled Substances Act; and
            ``(2) the term `relevant stakeholders' may include
        scientific experts within the drug manufacturing industry;
        brand and generic drug manufacturers; standard development
        organizations; wholesalers and distributors; payers; health
        care providers; pharmacists; pharmacies; manufacturers; poison
        centers; and representatives of the National Institute on Drug
        Abuse, the National Institutes of Health, the Centers for
        Disease Control and Prevention, the Centers for Medicare &
        Medicaid Services, the Drug Enforcement Agency, the Consumer
        Product Safety Commission, individuals who specialize in
        treating addiction, and patient and caregiver groups.''.
    (b) Prohibited Acts.--Section 501 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph
(j) the following:
    ``(k) If it is a drug approved under a covered application (as
defined in section 505-2(e)), the holder of which does not meet the
requirements of paragraphs (1) and (2) of subsection (b) of such
section.''.
    (c) Required Content of an Abbreviated New Drug Application.--
Section 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(2)(A)) is amended--
            (1) in clause (vii)(IV), by striking ``and'' at the end;
            (2) in clause (viii), by striking the period at the end and
        inserting ``; and''; and
            (3) by adding at the end the following:
            ``(ix) if the drug is or contains an opioid for which a
        listing in schedule II or III (on a temporary or permanent
        basis) is in effect under section 202 of the Controlled
        Substances Act, information to show that the applicant has
        proposed technologies, controls, or measures related to the
        packaging or disposal of the drug that provide protections
        comparable to those provided by the technologies, controls, or
        measures required for the applicable listed drug under section
        505-2, if applicable.''.
    (d) Grounds for Refusing to Approve an Abbreviated New Drug
Application.--Section 505(j)(4) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)(4)), is amended--
            (1) in subparagraph (J), by striking ``or'' at the end;
            (2) in subparagraph (K), by striking the period at the end
        and inserting ``; or''; and
            (3) by adding at the end the following:
                    ``(L) if the drug is a drug described in paragraph
                (2)(A)(ix) and the applicant has not proposed
                technologies, controls, or measures related to the
                packaging or disposal of such drug that the Secretary
                determines provide protections comparable to those
                provided by the technologies, controls, or measures
                required for the applicable listed drug under section
                505-2.''.
    (e) Rules of Construction.--
            (1) Any labeling describing technologies, controls, or
        measures related to packaging or disposal intended to mitigate
        the risk of abuse or misuse of a drug product that is subject
        to an abbreviated new drug application, including labeling
        describing differences from the reference listed drug resulting
        from the application of section 505-2 of the Federal Food,
        Drug, and Cosmetic Act, as added by subsection (a), shall not
        be construed--
                    (A) as changes to labeling not permissible under
                clause (v) of section 505(j)(2)(A) of such Act (21
                U.S.C. 355(j)(2)(A)), or a change in the conditions of
                use prescribed, recommended, or suggested in the
                labeling proposed for the new drug under clause (i) of
                such section; or
                    (B) to preclude approval of an abbreviated new drug
                application under subparagraph (B) or (G) of section
                505(j)(4) of such Act (21 U.S.C. 355(j)(4)).
            (2) For a covered application that is an application
        submitted under subsection (j) of section 505 of the Federal
        Food, Drug, and Cosmetic Act (21 U.S.C. 355), subsection
        (j)(2)(A) of such section 505 shall not be construed to limit
        the type of data or information the Secretary of Health and
        Human Services may request or consider in connection with
        making any determination under section 505-2.
    (f) GAO Report.--Not later than 12 months after the date of
enactment of this Act, the Comptroller General of the United States
shall prepare and submit to the Congress a report containing--
            (1) a description of available evidence, if any, on the
        effectiveness of site-of-use, in-home controlled substance
        disposal products and packaging technologies;
            (2) identification of ways in which such disposal products
        intended for use by patients, consumers, and other end users
        that are not registrants under the Controlled Substances Act,
        are made available to the public and barriers to the use of
        such disposal products;
            (3) identification of ways in which packaging technologies
        are made available to the public and barriers to the use of
        such technologies;
            (4) a description of Federal oversight, if any, of site-of-
        use, in-home controlled substance disposal products,
        including--
                    (A) identification of the Federal agencies that
                oversee such products;
                    (B) identification of the methods of disposal of
                controlled substances recommended by these agencies for
                site-of-use, in-home disposal; and
                    (C) a description of the effectiveness of such
                recommendations at preventing the diversion of legally
                prescribed controlled substances;
            (5) a description of Federal oversight, if any, of
        controlled substance packaging technologies, including--
                    (A) identification of the Federal agencies that
                oversee such technologies;
                    (B) identification of the technologies recommended
                by these agencies, including unit dose packaging,
                packaging that provides a set duration, or other
                packaging systems that may mitigate abuse or misuse;
                and
                    (C) a description of the effectiveness of such
                recommendations at preventing the diversion of legally
                prescribed controlled substances; and
            (6) recommendations on--
                    (A) whether site-of-use, in-home controlled
                substance disposal products and packaging technologies
                require Federal oversight and, if so, which agencies
                should be responsible for such oversight and, as
                applicable, approval of such products or technologies;
                and
                    (B) the potential role of the Federal Government in
                evaluating such products to ensure product efficacy.

            Passed the House of Representatives June 19, 2018.

            Attest:

                                                 KAREN L. HAAS,

                                                                 Clerk.

Summary: Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018 or the SOUND Disposal and Packaging Act This bill amends the Federal Food, Drug, and Cosmetic Act to authorize the Food and Drug Administration to require certain packaging and disposal technologies, controls, or measures to mitigate the risk of abuse or misuse of a drug or a class of drugs.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Unfunded Mandates Accountability Act
of 2011''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) The public has a right to know the benefits and costs
        of regulation. Regulations impose significant costs on
        individuals, employers, State, local, and tribal governments,
        diverting resources from other important priorities.
            (2) Better regulatory analysis and review should improve
        the quality of agency decisions, increasing the benefits and
        reducing unwarranted costs of regulation.
            (3) Disclosure and scrutiny of key information underlying
        agency decisions should make Government more accountable to the
        public it serves.

SEC. 3. REGULATORY IMPACT ANALYSES FOR CERTAIN RULES.

    Section 202 of the Unfunded Mandates Reform Act of 1995 (2 U.S.C.
1532) is amended--
            (1) by striking the section heading and inserting the
        following:

``SEC. 202. REGULATORY IMPACT ANALYSES FOR CERTAIN RULES.'';

            (2) by redesignating subsections (b) and (c) as subsections
        (d) and (e), respectively;
            (3) by striking subsection (a) and inserting the following:
    ``(a) Definition.--In this section, the term `cost' means the cost
of compliance and any reasonably foreseeable indirect costs, including
revenues lost as a result of an agency rule subject to this section.
    ``(b) In General.--Before promulgating any proposed or final rule
that may have an annual effect on the economy of $100,000,000 or more
(adjusted for inflation), or that may result in the expenditure by
State, local, and tribal governments, in the aggregate, of $100,000,000
or more (adjusted for inflation) in any 1 year, each agency shall
prepare and publish in the Federal Register an initial and final
regulatory impact analysis. The initial regulatory impact analysis
shall accompany the agency's notice of proposed rulemaking and shall be
open to public comment. The final regulatory impact analysis shall
accompany the final rule.
    ``(c) Content.--The initial and final regulatory impact analysis
under subsection (b) shall include--
            ``(1)(A) an analysis of the anticipated benefits and costs
        of the rule, which shall be quantified to the extent feasible;
            ``(B) an analysis of the benefits and costs of a reasonable
        number of regulatory alternatives within the range of the
        agency's discretion under the statute authorizing the rule,
        including alternatives that--
                    ``(i) require no action by the Federal Government;
                and
                    ``(ii) use incentives and market-based means to
                encourage the desired behavior, provide information
                upon which choices can be made by the public, or employ
                other flexible regulatory options that permit the
                greatest flexibility in achieving the objectives of the
                statutory provision authorizing the rule; and
            ``(C) an explanation that the rule meets the requirements
        of section 205;
            ``(2) an assessment of the extent to which--
                    ``(A) the costs to State, local, and tribal
                governments may be paid with Federal financial
                assistance (or otherwise paid for by the Federal
                Government); and
                    ``(B) there are available Federal resources to
                carry out the rule;
            ``(3) estimates of--
                    ``(A) any disproportionate budgetary effects of the
                rule upon any particular regions of the Nation or
                particular State, local, or tribal governments, urban
                or rural or other types of communities, or particular
                segments of the private sector; and
                    ``(B) the effect of the rule on job creation or job
                loss, which shall be quantified to the extent feasible;
                and
            ``(4)(A) a description of the extent of the agency's prior
        consultation with elected representatives (under section 204)
        of the affected State, local, and tribal governments;
            ``(B) a summary of the comments and concerns that were
        presented by State, local, or tribal governments either orally
        or in writing to the agency; and
            ``(C) a summary of the agency's evaluation of those
        comments and concerns.'';
            (4) in subsection (d) (as redesignated by paragraph (2) of
        this subsection), by striking ``subsection (a)'' and inserting
        ``subsection (b)''; and
            (5) in subsection (e) (as redesignated by paragraph (2) of
        this subsection), by striking ``subsection (a)'' each place
        that term appears and inserting ``subsection (b)''.

SEC. 4. LEAST BURDENSOME OPTION OR EXPLANATION REQUIRED.

    Section 205 of the Unfunded Mandates Reform Act of 1995 (2 U.S.C.
1535) is amended to read as follows:

``SEC. 205. LEAST BURDENSOME OPTION OR EXPLANATION REQUIRED.

    ``Before promulgating any proposed or final rule for which a
regulatory impact analysis is required under section 202, the agency
shall--
            ``(1) identify and consider a reasonable number of
        regulatory alternatives within the range of the agency's
        discretion under the statute authorizing the rule, including
        alternatives required under section 202(c)(1)(B); and
            ``(2) from the alternatives described under paragraph (1),
        select the least costly, most cost-effective, or least
        burdensome alternative that achieves the objectives of the
        statute.''.

SEC. 5. INCLUSION OF APPLICATION TO INDEPENDENT REGULATORY AGENCIES.

    (a) In General.--Section 421(1) of the Congressional Budget and
Impoundment Control Act of 1974 (2 U.S.C. 658(1)) is amended by
striking ``, but does not include independent regulatory agencies''.
    (b) Exemption for Monetary Policy.--The Unfunded Mandates Reform
Act of 1995 (2 U.S.C. 1501 et seq.) is amended by inserting after
section 5 the following:

``SEC. 6. EXEMPTION FOR MONETARY POLICY.

    ``Nothing in title II, III, or IV shall apply to rules that concern
monetary policy proposed or implemented by the Board of Governors of
the Federal Reserve System or the Federal Open Market Committee.''.

SEC. 6. JUDICIAL REVIEW.

    Section 401 of the Unfunded Mandates Reform Act of 1995 (2 U.S.C.
1571) is amended to read as follows:

``SEC. 401. JUDICIAL REVIEW.

    ``(a) In General.--For any rule subject to section 202, a party
aggrieved by final agency action is entitled to judicial review of an
agency's analysis under and compliance with subsections (b) and (c)(1)
of section 202 and section 205. The scope of review shall be governed
by chapter 7 of title 5, United States Code.
    ``(b) Jurisdiction.--Each court having jurisdiction to review a
rule subject to section 202 for compliance with section 553 of title 5,
United States Code, or under any other provision of law, shall have
jurisdiction to review any claims brought under subsection (a) of this
section.
    ``(c) Relief Available.--In granting relief in an action under this
section, the court shall order the agency to take remedial action
consistent with chapter 7 of title 5, United States Code, including
remand and vacatur of the rule.''.

SEC. 7. EFFECTIVE DATE.

    This Act shall take effect 90 days after the date of enactment of
this Act.

Summary: Unfunded Mandates Accountability Act of 2011 - Amends the Unfunded Mandates Reform Act of 1995 to: (1) require regulatory impact analyses for rules that do not involve a legislative mandate and for final rules that do not have a prior notice of proposed rulemaking. (2) require federal agencies to prepare and publish in the Federal Register an initial and final regulatory impact analysis prior to promulgating any proposed or final rule that may have an annual effect on the economy of $100 million or more or that may result in the expenditure of $100 million or more in any one year by state, local, and tribal governments. (3) require such agencies to identify and consider regulatory alternatives before promulgating any proposed or final rule and select the least costly, most cost-effective, or least burdensome alternative. (4) define cost as the cost of compliance and any reasonably foreseeable indirect cost resulting from agency rulemaking. (5) exempt rules concerning monetary policy proposed or implemented by the Board of Governors of the Federal Reserve System or the Federal Open Market Committee from provisions of such Act relating to regulatory accountability and reform, review of federal mandates, and judicial review. And (6) expand provisions relating to judicial review of regulatory impact analyses. Amends the Congressional Budget and Impoundment Control Act of 1974 to require independent regulatory agencies to conduct regulatory impact analyses.

To amend the Unfunded Mandates Reform Act of 1995 to provide for regulatory impact analyses for certain rules, consideration of the least burdensome regulatory alternative, and for other purposes.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Home Energy Savings Incentives Act
of 2005''.

SEC. 2. MODIFICATION OF CREDIT FOR CERTAIN NONBUSINESS ENERGY PROPERTY.

    (a) In General.--Section 25C of the Internal Revenue Code of 1986
is amended to read as follows:

``SEC. 25C. NONBUSINESS ENERGY PROPERTY.

    ``(a) Allowance of Credit.--In the case of an individual, there
shall be allowed as a credit against the tax imposed by this chapter
for the taxable year an amount equal to the sum of--
            ``(1) $10 for each therm of certified natural gas savings
        attributable to qualified energy efficiency expenditures made
        during the taxable year, and
            ``(2) $0.65 for each kilowatt hour of certified electricity
        savings attributable to qualified energy efficiency
        expenditures made during the taxable year.
    ``(b) Lifetime Limitation.--The credit allowed under this section
with respect to any taxpayer for any taxable year shall not exceed the
excess (if any) of $5,000 over the aggregate credits allowed under this
section with respect to such taxpayer for all prior taxable years.
    ``(c) Qualified Energy Efficiency Expenditures.--For purposes of
this section--
            ``(1) In general.--The term `qualified energy efficiency
        expenditures' means expenditures made by the taxpayer, after
        consultation with a qualified individual described in
        subsection (d)(2)(C), for the improvement of a dwelling unit of
        the taxpayer located in the United States and used by the
        taxpayer as the taxpayer's principal residence.
            ``(2) No double benefit for certain expenditures.--The term
        `qualified energy efficiency expenditures' shall not include
        any expenditure for which a deduction or credit is otherwise
        allowed under this chapter.
            ``(3) Principal residence.--
                    ``(A) In general.--The term `principal residence'
                has the same meaning as when used in section 121,
                except that--
                            ``(i) no ownership requirement shall be
                        imposed, and
                            ``(ii) the period for which a building is
                        treated as used as a principal residence shall
                        also include the 60-day period ending on the
                        1st day on which it would (but for this
                        subparagraph) first be treated as used as a
                        principal residence.
                    ``(B) Manufactured housing.--The term `residence'
                shall include a dwelling unit which is a manufactured
                home conforming to Federal Manufactured Home
                Construction and Safety Standards (24 C.F.R. 3280).
    ``(d) Certified Natural Gas Savings; Certified Electricity
Savings.--
            ``(1) In general.--
                    ``(A) Certified natural gas savings.--The term
                `certified natural gas savings' means, with respect to
                any taxable year, the amount, measured in therms on an
                average annual basis, which is equal to the excess of--
                            ``(i) 85 percent of the amount of natural
                        gas which would be consumed with respect to the
                        dwelling unit of the taxpayer if the qualified
                        energy efficiency expenditures with respect to
                        such taxable year were not made, as certified
                        in accordance with paragraph (2), over
                            ``(ii) the amount of such natural gas
                        consumption with respect to such dwelling unit
                        determined by taking into account the qualified
                        energy efficiency expenditures made during such
                        taxable year, as certified in accordance with
                        paragraph (2).
                    ``(B) Certified electricity savings.--The term
                `certified electricity savings' means, with respect to
                any taxable year, the amount, measured in kilowatt
                hours on an annual basis, which is equal to the excess
                of--
                            ``(i) 85 percent of the amount of
                        electricity which would be consumed with
                        respect to the dwelling unit of the taxpayer if
                        the qualified energy efficiency expenditures
                        with respect to such taxable year were not
                        made, as certified in accordance with paragraph
                        (2), over
                            ``(ii) the amount of electricity
                        consumption with respect to such dwelling unit
                        determined by taking into account the qualified
                        energy efficiency expenditures made during such
                        taxable year, as certified in accordance with
                        paragraph (2).
            ``(2) Certification.--
                    ``(A) In general.--The Secretary shall prescribe
                the manner and method for the making of certifications
                under this paragraph.
                    ``(B) Procedures.--The Secretary shall include as
                part of the certification process procedures for
                inspection and testing by qualified individuals
                described in subparagraph (C) to ensure compliance of
                dwelling units with the requirements of this section.
                Such procedures shall be similar to the requirements in
                the Mortgage Industry National Accreditation Procedures
                for Home Energy Rating Systems.
                    ``(C) Qualified individuals.--Individuals qualified
                to determine compliance shall be only those individuals
                who are recognized by an organization certified by the
                Secretary for such purposes.
    ``(e) Special Rules.--For purposes of this section, rules similar
to the rules under paragraphs (4), (5), (6), (7), (8), and (9) of
section 25D(e) shall apply.
    ``(f) Basis Adjustments.--For purposes of this subtitle, if a
credit is allowed under this section with respect to any expenditure
with respect to any property, the increase in the basis of such
property which would (but for this subsection) result from such
expenditure shall be reduced by the amount of the credit so allowed.
    ``(g) Termination.--This section shall not apply with respect to
any property placed in service after December 31, 2007.''.
    (b) Conforming Amendment.--Section 1016(a)(34) is amended by
striking ``25C(e)'' and inserting ``section 25C(f)''.
    (c) Effective Dates.--The amendments made by this section shall
apply to property placed in service after December 31, 2005.

Summary: Home Energy Savings Incentives Act of 2005 - Amends the Internal Revenue Code to revise the tax credit for nonbusiness energy property enacted by the Energy Policy Act of 2005 to allow an individual taxpayer a credit equal to $10 for each therm of certified natural gas savings and $0.65 for each kilowatt hour of certified electricity savings attributable to energy efficiency improvements made to the taxpayer's principal residence. Limits the amount of such credit to $5,000, less credits received for all prior taxable years. Requires the Secretary of the Treasury to prescribe the manner and method for making energy savings certifications for purposes of the tax credit. Terminates the credit after December 31, 2007.

A bill to amend the Internal Revenue Code of 1986 to modify the credit for nonbusiness energy property so that the amount of the credit is determined based on the amount of energy savings achieved by the taxpayer.