TASK DEFINITION: In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
PROBLEM: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Protection of Lawful Commerce in
Arms Act''.

SEC 2. AMENDMENT TO ORGANIC ACT.

The Act entitled ''An Act to establish the Department of Commerce
and Labor'', approved February 14, 1903 (15 U.S.C. 1501 et seq.), is
amended by redesignating section 13 as section 14 and by inserting
after section 12 the following:

''SEC. 13. RESTRICTION ON COMMERCE.

''(a) Secretary of Commerce List.--The Secretary of Commerce shall
establish and maintain a list consisting of each person that notifies
the Secretary under subsection (b) that it is a manufacturer or seller
in interstate or foreign commerce of a firearm or ammunition product or
is a trade association representing such manufacturers or sellers. The
list shall contain the name of the person, the chief executive officer
of the person, and the address and location of the headquarters of the
person. The Secretary shall maintain and update the list and may
publish the list in the Federal Register.
''(b) Notification.--Each person that--
''(1) is a manufacturer in interstate or foreign commerce
of a firearm or ammunition product, and is licensed to engage
in business as such manufacturer to the extent required under
chapter 44 of title 18, United States Code,
''(2) is a seller in interstate or foreign commerce of a
firearm or ammunition product, and is licensed to engage in
business as such seller to the extent required under chapter 44
of title 18, United States Code, or
''(3) is a trade association representing such
manufacturers or sellers,
may notify the Secretary of its existence and provide to the Secretary
the information described in subsection (a).
''(c) Freedom From Restriction.--Conduct that--
''(1)(A) is carried out by a manufacturer in interstate or
foreign commerce of a firearm or ammunition product, involves
such firearm or ammunition product, and is described in
paragraph (4) of subsection (d);
''(B) is carried out by a seller in interstate or foreign
commerce of a firearm or ammunition product, involves a firearm
or ammunition product, and is described in paragraph (6) of
subsection (d); or
''(C) is carried out by a trade association in the course
of organizing, advising, or representing its members who are
manufacturers in interstate or foreign commerce of a firearm or
ammunition product, or who are sellers in interstate or foreign
commerce of a firearm or ammunition product, with respect to
conduct of such manufacturers or sellers described in paragraph
(4) or (6) of subsection (d), as the case may be; and
''(2) is lawful under chapter 44 of title 18, United States
Code, or under applicable State law;
shall not be a basis for imposing a restriction on interstate or
foreign commerce on a person on the list described in subsection (a) as
a result of harm caused by the criminal or other unlawful misuse of
such firearm or ammunition product by any other person.
''(d) Definitions.--In this section:
''(1) Ammunition product.--The term 'ammunition product'
means 'ammunition' as defined in section 921(a)(17) of title
18, United States Code, and includes a component part of such
ammunition product that has been shipped or transported in
interstate or foreign commerce.
''(2) Firearm product.--The term 'firearm product' means
'firearm' as defined in subparagraph (A) or (B) section
921(a)(3) of title 18, United States Code, and includes any
'antique firearm' as defined in section 921(a)(16) of such
title, and includes a component part of such a firearm that has
been shipped or transported in interstate or foreign commerce.
''(3) Interstate or foreign commerce.--The term 'interstate
or foreign commerce' has the meaning given that term in
section 921(a)(2) of title 18, United States Code.
''(4) Manufacturer.--The term 'manufacturer in interstate
or foreign commerce of a firearm or ammunition product' means--
''(A) a person who, in the course of a business in
interstate or foreign commerce to import, make,
produce, create, assemble, design, or formulate a
firearm or ammunition product, imports, makes,
produces, creates, assembles, designs, or formulates a
firearm or ammunition product, or engages another
person to import, make, produce, create, assemble,
design, or formulate a firearm or ammunition product;
''(B) a seller in interstate or foreign commerce of
a firearm or ammunition product made by another person,
but only with respect to an aspect of the firearm or
ammunition product that the seller makes, produces,
creates, assembles, designs, or formulates; and
''(C) any seller in interstate or foreign commerce
of a firearm or ammunition product on which, or on the
packaging of which, the seller is also represented as
the manufacturer of the firearm or ammunition product.
''(5) Restriction on interstate or foreign commerce.--The
term 'restriction on interstate or foreign commerce'--
''(A) means--
''(i) civil damages or equitable relief, or
''(ii) any other limitation or condition,
awarded or ordered by a Federal, State, or local court,
that restricts the ability of a person listed under
subsection (a) to freely engage in interstate or
foreign commerce with respect to firearm or ammunition
products, or of a trade association listed under
subsection (a) to freely engage in lawful activities on
behalf of its membership; and
''(B) does not include any damages, equitable
relief, or other limitation or condition arising from--
''(i) breach of contract or warranty in
connection with the purchase of a firearm or
ammunition product; or
''(ii) physical injuries or property damage
resulting directly from the failure to function
or improper functioning of a firearm or
ammunition product, when used as intended, due
to a defect in design or manufacture.
''(6) Seller.--The term 'seller in interstate or foreign
commerce of a firearm or ammunition product' means a person
who--
''(A) in the course of a business conducted in
interstate or foreign commerce for such purpose, sells,
distributes, rents, leases, prepares, blends, packages,
labels, or otherwise is involved in placing a firearm
or ammunition product in the stream of commerce; or
''(B) in the course of a business conducted in
interstate or foreign commerce for such purpose,
installs, repairs, refurbishes, reconditions, or
maintains an aspect of a firearm or ammunition product.
''(7) State.--The term 'State' includes the District of
Columbia, the Commonwealth of Puerto Rico, and any territory or
possession of the United States.
''(8) Trade association.--The term 'trade association'
means any association or business organization (whether or not
incorporated under the laws of any State), 2 or more members of
which are manufacturers or sellers in interstate or foreign
commerce of a firearm or ammunition product.
''(e) Limitation on Use of List.--No officer, agency, or
instrumentality of the United States may use the list established and
maintained under this section for any purpose other than the
enforcement of the provisions of this section, nor shall the list be
used or allowed to be used in any way that would result in the creation
of any registry of firearms, firearm owners, or firearm purchasers by
the United States, or by any State or any political subdivision
thereof.''.

SOLUTION: Protection of Lawful Commerce in Arms Act - Amends the Organic Act establishing the Department of Commerce to direct the Secretary of Commerce to establish and maintain a list of each person that notifies the Secretary that it is a manufacturer or seller that is: (1) licensed to engage in interstate or foreign commerce of a firearm (including antique firearm) or ammunition product; or (2) is a trade association representing such manufacturers or sellers. Declares that any lawful conduct carried out by a manufacturer or seller in interstate or foreign commerce of a firearm or ammunition product, or lawful conduct carried out by a trade association in the course of representing such manufacturers or sellers, shall not be the basis for imposing a restriction on such commerce (the award of civil damages, equitable relief, or any other specified limitation) as a result of harm caused by the criminal or other unlawful misuse of such firearm or ammunition product by any other person.

PROBLEM: SECTION 1. SHORT TITLE.

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

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

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

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

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

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

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

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

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

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

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

SEC. 5. GUIDANCE ON TARGET PRODUCT PROFILES.

Not later than 18 months after the date of enactment of this Act,
the Commissioner of Food and Drugs, in consultation with the
Administrator of the Centers for Medicare & Medicaid Services, the
Director of the Indian Health Service, the Secretary of Defense, and
the Secretary of Veterans Affairs, shall issue guidance on the
development of target product profiles for novel antibacterial drugs
focused on public health priorities.

SOLUTION: Helping Effective Antibiotics Last Act of 2015 or the HEAL Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to approve an antibacterial drug or biological product that is intended to treat a serious or life-threatening condition only for treating a well-defined population of patients. To be approved, the antibacterial product must produce superior outcomes over available therapies in the well-defined patient population. A product approved by this pathway must include in its prescribing information the population of patients expected to benefit from using the product and the method for identifying members of that population. The FDA must require each product to have a risk evaluation and mitigation strategy. The Centers for Disease Control and Prevention must monitor changes to bacterial drug resistance and changes to patient outcomes caused by bacterial drug resistance. Upon approval of antibacterial products, the FDA must identify susceptibility test interpretive criteria (the drug concentrations where a type of bacteria is categorized as susceptible, intermediate, or resistant) and update the criteria as needed based upon evidence of changes in patient outcomes. To be eligible for an exclusivity period extension, a qualified infectious disease product must be demonstrated to produce superior outcomes over available therapies. The FDA must issue guidance on the development of target product profiles for antibacterial drugs.

PROBLEM: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Agricultural Mediation Improvement
Act of 1994''.

SEC. 2. EXPANSION OF AGRICULTURAL ISSUES COVERED BY STATE MEDIATION
PROGRAMS.

(a) Expansion of Mediation Programs.--Section 501 of the
Agricultural Credit Act of 1987 (7 U.S.C. 5101) is amended--
(1) in subsection (a), by striking ''an agricultural loan
mediation program'' and inserting ''a mediation program''; and
(2) in subsection (b), by striking ''agricultural loan'';
and
(3) by striking subsection (c) and inserting the following
new subsection:
''(c) Requirements of State Mediation Programs.--
''(1) Agricultural issues covered.--To be certified as a
qualifying State, the mediation program of the State must
provide mediation services to producers, their creditors (if
applicable), other persons directly affected by actions of the
Department of Agriculture, and the Department of Agriculture,
involved in one or more of the following agricultural issues:
''(A) Agricultural loans.
''(B) Wetlands determinations under the
jurisdiction of the Department.
''(C) Compliance with farm programs, including
conservation programs of the Department.
''(D) Agricultural credit.
''(E) Rural water loan programs.
''(F) Grazing on National Forest System lands.
''(G) Pesticides.
''(H) Such other agricultural issues under the
jurisdiction of the Department as the Secretary
considers appropriate.
''(2) Certification conditions.--The Secretary shall
certify a State as a qualifying State with respect to the
agricultural issues proposed to be covered by the mediation
program of the State if the mediation program--
''(A) provides for mediation services that, if
decisions are reached, result in mediated, mutually
agreeable decisions between the parties to the
mediation;
''(B) is authorized or administered by an agency of
the State government or by the Governor of the State;
''(C) provides for the training of mediators;
''(D) provides that the mediation sessions shall be
confidential;
''(E) ensures, in the case of agricultural loans,
that all lenders and borrowers of agricultural loans
receive adequate notification of the mediation program;
and
''(F) ensures, in the case of other agricultural
issues covered by the mediation program, that persons
directly affected by actions of the Department of
Agriculture receive adequate notification of the
mediation program.
''(3) Time for certification.--The Secretary shall make a
determination whether to certify a State as a qualifying State
not later than 15 days after the Secretary receives a
description of the proposed mediation program of the State.''.
(b) Participation of Department.--Section 503 of such Act (7 U.S.C.
5103) is amended--
(1) by striking ''agricultural loan'' each place it
appears;
(2) in the matter preceding subparagraph (A) of subsection
(a)(1)--
(A) by inserting ''or agency'' after ''program'';
and
(B) by striking ''that makes, guarantees, or
insures agricultural loans'';
(3) in subsection (a)(1)(A)--
(A) by inserting ''or agency'' after ''such
program''; and
(B) by inserting ''certified under section 501''
after ''mediation program'';
(4) in subsection (a)(1)(B)--
(A) by striking '', effective beginning on the date
of the enactment of this Act,''; and
(B) by inserting ''certified under section 501''
after ''mediation programs''; and
(5) in subsection (a)(1)(C)--
(A) in clause (i), by striking ''described in'' and
inserting ''certified under''; and
(B) in clause (ii), by inserting ''if applicable,''
before ''present''.
(c) Regulations.--Section 504 of such Act (7 U.S.C. 5104) is
amended--
(1) by striking ''Within 150 days after the date of the
enactment of this Act, the '' and inserting ''The''; and
(2) by adding at the end the following new sentence: ''The
regulations prescribed by the Secretary shall require
qualifying States to adequately train mediators to address all
of the agricultural issues covered by the mediation program of
the State.''.
(d) Report.--Section 505 of such Act (7 U.S.C. 5105) is amended by
striking ''1990'' and inserting ''1998''.
(e) Authorization of Appropriations.--Section 506 of such Act (7
U.S.C. 5106) is amended by striking ''1995'' and inserting ''2000''.
(f) Conforming Amendments.--
(1) References to agricultural loans.--Subtitle A of title
V of such Act is amended--
(A) in sections 502 and 505(1) (7 U.S.C. 5102,
5105(1)), by striking ''agricultural loan'' each place
it appears; and
(B) in section 505(3) (7 U.S.C. 5105(3)), by
striking ''an agricultural loan mediation'' and
inserting ''a mediation''.
(2) Waiver of farm credit mediation rights by borrowers.--
Section 4.14E of the Farm Credit Act of 1971 (12 U.S.C. 2202e)
is amended by striking ''agricultural loan''.
(3) Waiver of fmha mediation rights by borrowers.--Section
358 of the Consolidated Farm and Rural Development Act (7
U.S.C. 2006) is amended by striking ''agricultural loan''.

SOLUTION:
Agricultural Mediation Improvement Act of 1994 - Amends the Agricultural Credit Act of 1987 to expand the types of agricultural issues covered by State mediation programs.
Extends the authorization of appropriations for such programs.