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

SECTION 1. LIABILITY OF BUSINESS ENTITIES PROVIDING USE OF FACILITIES
TO NONPROFIT ORGANIZATIONS.

(a) Definitions.--In this section:
(1) Business entity.--The term ''business entity'' means a
firm, corporation, association, partnership, consortium, joint
venture, or other form of enterprise.
(2) Facility.--The term ''facility'' means any real
property, including any building, improvement, or appurtenance.
(3) Gross negligence.--The term ''gross negligence'' means
voluntary and conscious conduct by a person with knowledge (at
the time of the conduct) that the conduct is likely to be
harmful to the health or well-being of another person.
(4) Intentional misconduct.--The term ''intentional
misconduct'' means conduct by a person with knowledge (at the
time of the conduct) that the conduct is harmful to the health
or well-being of another person.
(5) Nonprofit organization.--The term ''nonprofit
organization'' means--
(A) any organization described in section 501(c)(3)
of the Internal Revenue Code of 1986 and exempt from
tax under section 501(a) of such Code; or
(B) any not-for-profit organization organized and
conducted for public benefit and operated primarily for
charitable, civic, educational, religious, welfare, or
health purposes.
(6) State.--The term ''State'' means each of the several
States, the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, Guam, American Samoa, the Northern
Mariana Islands, any other territory or possession of the
United States, or any political subdivision of any such State,
territory, or possession.
(b) Limitation on Liability.--
(1) In general.--Subject to subsection (c), a business
entity shall not be subject to civil liability relating to any
injury or death occurring at a facility of the business entity
in connection with a use of such facility by a nonprofit
organization if--
(A) the use occurs outside of the scope of business
of the business entity;
(B) such injury or death occurs during a period
that such facility is used by the nonprofit
organization; and
(C) the business entity authorized the use of such
facility by the nonprofit organization.
(2) Application.--This subsection shall apply--
(A) with respect to civil liability under Federal
and State law; and
(B) regardless of whether a nonprofit organization
pays for the use of a facility.
(c) Exception for Liability.--Subsection (b) shall not apply to an
injury or death that results from an act or omission of a business
entity that constitutes gross negligence or intentional misconduct,
including any misconduct that--
(1) constitutes a crime of violence (as that term is
defined in section 16 of title 18, United States Code) or act
of international terrorism (as that term is defined in section
2331 of title 18) for which the defendant has been convicted in
any court;
(2) constitutes a hate crime (as that term is used in the
Hate Crime Statistics Act (28 U.S.C. 534 note));
(3) involves a sexual offense, as defined by applicable
State law, for which the defendant has been convicted in any
court; or
(4) involves misconduct for which the defendant has been
found to have violated a Federal or State civil rights law.
(d) Superseding Provision.--
(1) In general.--Subject to paragraph (2) and subsection
(e), this Act preempts the laws of any State to the extent that
such laws are inconsistent with this Act, except that this Act
shall not preempt any State law that provides additional
protection from liability for a business entity for an injury
or death with respect to which conditions under subparagraphs
(A) through (C) of subsection (b)(1) apply.
(2) Limitation.--Nothing in this Act shall be construed to
supersede any Federal or State health or safety law.
(e) Election of State Regarding Nonapplicability.--This Act shall
not apply to any civil action in a State court against a business
entity in which all parties are citizens of the State if such State
enacts a statute--
(1) citing the authority of this subsection;
(2) declaring the election of such State that this Act
shall not apply to such civil action in the State; and
(3) containing no other provision.
Solution: Shields a business entity from civil liability relating to any injury or death occurring at a facility of that entity in connection with a use of such facility by a nonprofit organization if: (1) the use occurs outside the scope of business of the business entity; (2) such injury or death occurs during a period that such facility is used by such organization; and (3) the business entity authorized the use of such facility by the organization.
Makes this Act inapplicable to an injury or death that results from an act or omission of a business entity that constitutes gross negligence or intentional misconduct, including misconduct that: (1) constitutes a hate crime or a crime of violence or act of international terrorism for which the defendant has been convicted in any court; or (2) involves a sexual offense for which the defendant has been convicted in any court or misconduct for which the defendant has been found to have violated a Federal or State civil rights law.
Preempts State laws to the extent that such laws are inconsistent with this Act, except State law that provides additional protection from liability. Specifies that this Act shall not be construed to supersede any Federal or State health or safety law.
Makes this Act inapplicable to any civil action in a State court against a business entity in which all parties are citizens of the State if such State, citing this Act's authority and containing no other provision, enacts a statute declaring the State's election that this Act shall not apply to such action in the State.
Why? This Bill focuses on shielding business entities from civil liability relating to an injury or death depending on the conditions of injury, hence the generated summary is correct.

New input: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Preservation of Antibiotics for
Medical Treatment Act of 2015''.

SEC. 2. FINDINGS.

The Congress finds the following:
(1) All uses of antibiotics, including for food-producing
animals, have the potential to cause resistance and contribute
to the development of antibiotic-resistant bacterial infections
in people.
(2) In 1977, the Food and Drug Administration (FDA)
concluded that feeding livestock low doses of antibiotics used
in human disease treatment could promote the development of
antibiotic resistance in bacteria. However, the Food and Drug
Administration did not act in response to these findings,
despite laws requiring the agency to do so.
(3) In 2012, the Food and Drug Administration Guidance for
Industry #209 provided a summary of over 40 years of peer-
reviewed scientific literature regarding use of antimicrobial
drugs in livestock which reiterated that the use of antibiotics
in animals contributes to the resistance in human pathogens and
concludes that strategies for controlling antibiotic
resistance, including limiting medically important
antimicrobial drugs in food-producing animals only to uses that
are considered necessary for assuring animal health are needed.
(4) The 2014 President's Council of Advisors on Science and
Technology Report to the President on Combating Antibiotic-
Resistant Bacteria also concludes that substantial evidence
exists that the use of antibiotics in food animals promotes the
development and spread of antibiotic resistance in bacteria
that can spread to people and that it is clear that
agricultural use of antibiotics can affect human health.
(5) Recently published scientific studies have shown that
food-producing animals, and animal production facilities, are a
source of antibiotic-resistant bacteria which have infected
humans and present an increased risk of acquiring and
antibiotics resistant infection.
(6) Antibiotic resistance is a crisis which threatens
public health, the economy, and national security.
(7) In 2013, the Centers for Disease Control and Prevention
estimated that antibiotic-resistant infections cause at least 2
million infections, 23,000 deaths, 8 million additional
hospital days, and $20 to $35 billion in excess direct health
care costs each year in the United States.
(8) The 2014 World Health Organization report,
''Antimicrobial Resistance: Global Report on Surveillance
2014'', concluded that antimicrobial resistance is a current
reality and the problem is so serious that it threatens the
achievements of modern medicine.
(9) Without effective antibiotics--
(A) common infections could become untreatable--
even fatal; and
(B) medical advances such as joint replacements,
Cesarean sections, organ transplants and chemotherapy
could become nonviable.
(10) Antibiotic resistance, resulting in a reduced number
of effective antibiotics, may significantly impair the ability
of the United States to respond to terrorist attacks involving
bacterial infections, such as anthrax and smallpox, or to an
event resulting in a large influx of hospitalized patients.
(11) In 2011, the Food and Drug Administration determined
that--
(A) 13.5 million kilograms of antibacterial drugs
were sold for use on food animals in the United States
in 2010;
(B) 3.3 million kilograms of antibacterial drugs
were used for human health in 2010; and
(C) therefore, 80 percent of antibacterial drugs
disseminated in the United States in 2010 were sold for
use on food animals, rather than being used for human
health.
(12) The ''FDA Annual Summary Report on Antimicrobials Sold
or Distributed in 2012 for Use in Food-Producing Animals''
showed that the use of medically important antibiotics in food-
producing animals increased 16 percent from 2009 to 2012.
(13)(A) In 2003, the Food and Drug Administration modified
the drug approval process for antibiotics to recognize the
development of resistant bacteria as an important aspect of
safety, but most antibiotics currently used in animal
production systems for nontherapeutic purposes were approved
before the Food and Drug Administration began considering
resistance during the drug-approval process.
(B) The Food and Drug Administration has not established a
schedule for reviewing those existing approvals.
(14) A stated goal of FDA Guidance documents 209 and 213 is
a reduction in the overall consumption of antibiotics. The FDA
policy continues to allow the use of antibiotics for routine
disease prevention without requiring evidence of the presence
of a specific disease or requiring the mitigation of conditions
which elevate disease risk.
(15) There is inadequate distinction between usage for
disease prevention and production purposes, such as growth
promotion, on FDA approved drug labels. A 2014 analysis of the
approved animal drugs affected by Guidance 213 by the Pew
Charitable Trusts found that numerous approved drug labels
contained overlapping indications for growth-promotion and
disease prevention.
(16) The European Union (EU) banned the use of antibiotics
for growth promotion in 2006, a full decade before the FDA's
voluntary approach will go into effect.
(17) Since the EU ban, antibiotic usage has decreased
without affecting livestock production.
(18) In 2010, the Danish Veterinary and Food Administration
testified that the Danish ban of the nontherapeutic use of
antibiotics in food-animal production resulted in a marked
reduction in antimicrobial resistance in multiple bacterial
species, including Campylobacter and Enterococci.
(19) The experience in the Netherlands has shown that
during the phaseout use indications for growth promotion were
completely supplanted by disease prevention. Total antibiotic
consumption remained constant. After the implementation of
mandatory reduction targets and improved surveillance of usage
practices antibiotic consumption declined ahead of target
without impacting production levels.
(20) In 2009, the Congressional Research Service concluded
that without restrictions on the use of antimicrobial drugs in
the production of livestock, export markets for livestock and
poultry could be negatively impacted due to restrictions on the
use of antibiotics in other nations.
(21) The American Medical Association, the Infectious
Disease Society of America, the American Public Health
Association, the National Association of County and City Health
Officials, and the National Sustainable Agriculture Coalition
are among the over 400 organizations representing health,
consumer, agricultural, environmental, humane, and other
interests that have supported enactment of legislation to
phaseout nontherapeutic use in farm animals of medically
important antimicrobials.

SEC. 3. PURPOSE.

The purpose of this Act is to preserve the effectiveness of
medically important antimicrobials used in the treatment of human and
animal diseases.

SEC. 4. PROOF OF SAFETY OF MEDICALLY IMPORTANT ANTIMICROBIALS.

(a) Applications Pending or Submitted After Enactment.--Section
512(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360b(d)(1)) is amended--
(1) in the first sentence--
(A) in subparagraph (H), by striking ''or'' at the
end;
(B) in subparagraph (I), by inserting ''or'' at the
end; and
(C) by inserting after subparagraph (I) the
following:
''(J) with respect to a medically important
antimicrobial (as defined in subsection (q)), the
applicant has failed to demonstrate that there is a
reasonable certainty of no harm to human health due to
the development of antimicrobial resistance that is
attributable, in whole or in part, to the
nontherapeutic use (as defined in subsection (q)) of
the medically important antimicrobial or drug;''; and
(2) in the second sentence, by striking ''(A) through (I)''
and inserting ''(A) through (J)''.
(b) Phased Elimination of Nontherapeutic Use in Animals of
Medically Important Antimicrobials.--Section 512 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b) is amended by adding at the end
the following:
''(q) Phased Elimination of Nontherapeutic Use in Animals of
Medically Important Antimicrobials.--
''(1) Applicability.--This paragraph applies to the
nontherapeutic use in a food-producing animal of a drug--
''(A) that is a medically important antimicrobial;
or
''(B)(i) for which there is in effect an approval
of an application or an exemption under subsection (b),
(i), or (j) of section 505; or
''(ii) that is otherwise marketed for human use.
''(2) Withdrawal.--The Secretary shall withdraw the
approval of a nontherapeutic use in food-producing animals of a
drug described in paragraph (1) on the date that is 2 years
after the date of enactment of this subsection unless--
''(A) before the date that is 2 years after the
date of the enactment of this subsection, the Secretary
makes a final written determination that the holder of
the approved application has demonstrated that there is
a reasonable certainty of no harm to human health due
to the development of antimicrobial resistance that is
attributable in whole or in part to the nontherapeutic
use of the drug; or
''(B) before the date specified in subparagraph
(A), the Secretary makes a final written determination
under this subsection, with respect to a risk analysis
of the drug conducted by the Secretary and other
relevant information, that there is a reasonable
certainty of no harm to human health due to the
development of antimicrobial resistance that is
attributable in whole or in part to the nontherapeutic
use of the drug.
''(3) Exemptions.--Except as provided in paragraph (5), if
the Secretary grants an exemption under section 505(i) for a
drug that is a medically important antimicrobial, the Secretary
shall rescind each approval of a nontherapeutic use in a food-
producing animal of the medically important antimicrobial as of
the date that is 2 years after the date on which the Secretary
grants the exemption.
''(4) Approvals.--Except as provided in paragraph (5), if
an application for a drug that is a medically important
antimicrobial is submitted to the Secretary under section
505(b), the Secretary shall rescind each approval of a
nontherapeutic use in a food-producing animal of the medically
important antimicrobial as of the date that is 2 years after
the date on which the application is submitted to the
Secretary.
''(5) Exceptions.--Paragraph (3) or (4), as the case may
be, shall not apply if--
''(A) before the date on which approval would be
rescinded under that paragraph, the Secretary makes a
final written determination that the holder of the
application for the approved nontherapeutic use has
demonstrated that there is a reasonable certainty of no
harm to human health due to the development of
antimicrobial resistance that is attributable in whole
or in part to the nontherapeutic use in the food-
producing animal of the medically important
antimicrobial; or
''(B) before the date specified in subparagraph
(A), the Secretary makes a final written determination,
with respect to a risk analysis of the medically
important antimicrobial conducted by the Secretary and
any other relevant information, that there is a
reasonable certainty of no harm to human health due to
the development of antimicrobial resistance that is
attributable in whole or in part to the nontherapeutic
use of the medically important antimicrobial.
''(6) Definition.--In this subsection:
''(A) The term 'medically important antimicrobial'
means a drug that--
''(i) is intended for use in food-producing
animals; and
''(ii) is composed wholly or partly of--
''(I) any kind of penicillin,
tetracycline, macrolide, lincosamide,
streptogramin, aminoglycoside,
sulfonamide, or cephalosporin; or
''(II) a drug from an antimicrobial
class that is listed as 'highly
important', 'critically important', or
'important' by the World Health
Organization in the latest edition of
its publication entitled 'Critically
Important Antimicrobials for Human
Medicine' (or a successor publication).
''(B) The term 'therapeutic use', with respect to a
medically important antimicrobial, means the use of
antimicrobials for the specific purpose of treating an
animal with a documented disease or infection. Such
term does not include the continued use of such an
antimicrobial in the animal after the disease or
infection is resolved.
''(C) The term 'nontherapeutic use'--
''(i) means administration of antibiotics
to an animal through feed and water (or, in
poultry hatcheries, through any means) for
purposes (such as growth promotion, feed
efficiency, weight gain, or disease prevention)
other than therapeutic use or nonroutine
disease control; and
''(ii) includes any repeated or regular
pattern of use of medically important
antimicrobials for purposes other than
therapeutic use or nonroutine disease control.
''(D) The term 'noncustomary situation' does not
include normal or standard practice and conditions on
the premises that facilitate the transmission of
disease.
''(E) The term 'nonroutine disease control' means
the use of antibiotics on an animal that is not sick
but where it can be shown that a particular disease or
infection is present, or is likely to occur because of
a specific, noncustomary situation, on the premises at
the barn, house, pen, or other level at which the
animal is kept.''.

SEC. 5. LIMITATIONS ON USE OF MEDICALLY IMPORTANT ANTIMICROBIALS FOR
NONROUTINE DISEASE CONTROL.

(a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following:
''(ccc) The administration of a medically important antimicrobial
to a food-producing animal for nonroutine disease control in violation
of the requirements of section 512A.''.
(b) Requirements.--Chapter V of the Federal Food, Drug, and
Cosmetic Act is amended by inserting after section 512 of such Act (21
U.S.C. 360b) the following:

''SEC. 512A. LIMITATIONS ON USE OF MEDICALLY IMPORTANT ANTIMICROBIALS
FOR NONROUTINE DISEASE CONTROL.

''(a) Prohibition.--It shall be unlawful to administer (including
by means of animal feed) a medically important antimicrobial to a food-
producing animal for nonroutine disease control unless--
''(1) there is a significant risk that a disease or
infection present on the premises will be transmitted to the
food-producing animal;
''(2) the administration of the medically important
antimicrobial to the food-producing animal is necessary to
prevent or reduce the risk of transmission of the disease or
infection described in paragraph (1);
''(3) the medically important antimicrobial is administered
to the food-producing animal for nonroutine disease control for
the shortest duration possible to prevent or reduce the risk of
transmission of the disease or infection described in paragraph
(1) to the animal; and
''(4) the medically important antimicrobial is
administered--
''(A) at a scale no greater than the barn, house,
or pen level; and
''(B) to the fewest animals possible to prevent or
reduce the risk of transmission of the disease or
infection described in paragraph (1).
''(b) Definitions.--In this section:
''(1) The term 'food-producing animal' means a food-
producing animal intended for sale in interstate commerce.
''(2) The terms 'medically important antimicrobial' and
'nonroutine disease control' have the meanings given to such
terms in section 512(q).''.
(c) Applicability.--The amendments made by this section apply
beginning on the date that is 6 months after the date of the enactment
of this Act.
Solution:
Preservation of Antibiotics for Medical Treatment Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require an applicant for approval of a new animal drug that is a medically important antimicrobial to demonstrate that there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to the nontherapeutic use of the drug. Medically important antimicrobials are drugs intended for use in food-producing animals that contain: (1) specified antibiotics, or (2) certain drugs on the World Health Organization's list of critically important antimicrobials. Two years after enactment of this Act, the Food and Drug Administration (FDA) must withdraw approval of a drug's nontherapeutic use in food-producing animals unless the FDA makes a determination that, based on the application holder's demonstration or an FDA risk analysis, there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to nontherapeutic use. The FDA must rescind an exemption for investigational use of, or approval of a new drug application for, a medically important antimicrobial for its nontherapeutic use in food-producing animals two years after the exemption is granted or the application for approval is submitted unless there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to nontherapeutic use. A medically important antimicrobial cannot be administered (including through animal feed) to a food-producing animal for disease control unless there is a significant risk that a disease or infection present on the premises will be transmitted to the animal.