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. PERMANENT EXTENSION OF ESTATE TAX AS IN EFFECT IN 2009.

(a) Restoration of Unified Credit Against Gift Tax.--Paragraph (1)
of section 2505(a) (relating to general rule for unified credit against
gift tax), after the application of subsection (f), is amended by
striking ''(determined as if the applicable exclusion amount were
$1,000,000)''.
(b) Exclusion Equivalent of Unified Credit Equal to $3,500,000.--
Subsection (c) of section 2010 of the Internal Revenue Code of 1986
(relating to unified credit against estate tax) is amended to read as
follows:
''(c) Applicable Credit Amount.--
''(1) In general.--For purposes of this section, the
applicable credit amount is the amount of the tentative tax
which would be determined under section 2001(c) if the amount
with respect to which such tentative tax is to be computed were
equal to the applicable exclusion amount.
''(2) Applicable exclusion amount.--
''(A) In general.--For purposes of this subsection,
the applicable exclusion amount is $3,500,000.
''(B) Inflation adjustment.--In the case of any
decedent dying in a calendar year after 2010, the
dollar amount in subparagraph (A) shall be increased by
an amount equal to--
''(i) such dollar amount, multiplied by
''(ii) the cost-of-living adjustment
determined under section 1(f)(3) for such
calendar year by substituting 'calendar year
2009' for 'calendar year 1992' in subparagraph
(B) thereof.
If any amount as adjusted under the preceding sentence
is not a multiple of $10,000, such amount shall be
rounded to the nearest multiple of $10,000.''.
(c) Maximum Estate Tax Rate Equal to 45 Percent.--
(1) In general.--Subsection (c) of section 2001 of the
Internal Revenue Code of 1986 (relating to imposition and rate
of tax) is amended--
(A) by striking ''but not over $2,000,000'' in the
table contained in paragraph (1),
(B) by striking the last 2 items in such table,
(C) by striking ''(1) in general.--'', and
(D) by striking paragraph (2).
(2) Conforming amendment.--Paragraphs (1) and (2) of
section 2102(b) of such Code are amended to read as follows:
''(1) In general.--A credit in an amount that would be
determined under section 2010 as the applicable credit amount
if the applicable exclusion amount were $60,000 shall be
allowed against the tax imposed by section 2101.
''(2) Residents of possessions of the united states.--In
the case of a decedent who is considered to be a 'nonresident
not a citizen of the United States' under section 2209, the
credit allowed under this subsection shall not be less than the
proportion of the amount that would be determined under section
2010 as the applicable credit amount if the applicable
exclusion amount were $175,000 which the value of that part of
the decedent's gross estate which at the time of the decedent's
death is situated in the United States bears to the value of
the decedent's entire gross estate, wherever situated.''.
(d) Modifications of Estate and Gift Taxes To Reflect Differences
in Unified Credit Resulting From Different Tax Rates.--
(1) Estate tax.--
(A) In general.--Section 2001(b)(2) of the Internal
Revenue Code of 1986 (relating to computation of tax)
is amended by striking ''if the provisions of
subsection (c) (as in effect at the decedent's death)''
and inserting ''if the modifications described in
subsection (g)''.
(B) Modifications.--Section 2001 of such Code is
amended by adding at the end the following new
subsection:
''(g) Modifications to Gift Tax Payable To Reflect Different Tax
Rates.--For purposes of applying subsection (b)(2) with respect to 1 or
more gifts, the rates of tax under subsection (c) in effect at the
decedent's death shall, in lieu of the rates of tax in effect at the
time of such gifts, be used both to compute--
''(1) the tax imposed by chapter 12 with respect to such
gifts, and
''(2) the credit allowed against such tax under section
2505, including in computing--
''(A) the applicable credit amount under section
2505(a)(1), and
''(B) the sum of the amounts allowed as a credit
for all preceding periods under section 2505(a)(2).
For purposes of paragraph (2)(A), the applicable credit amount
for any calendar year before 1998 is the amount which would be
determined under section 2010(c) if the applicable exclusion
amount were the dollar amount under section 6018(a)(1) for such
year.''.
(2) Gift tax.--Section 2505(a) of such Code (relating to
unified credit against gift tax) is amended by adding at the
end the following new flush sentence:
''For purposes of applying paragraph (2) for any calendar year, the
rates of tax in effect under section 2502(a)(2) for such calendar year
shall, in lieu of the rates of tax in effect for preceding calendar
periods, be used in determining the amounts allowable as a credit under
this section for all preceding calendar periods.''.
(e) Effective Date.--The amendments made by this section shall
apply to estates of decedents dying, generation-skipping transfers, and
gifts made, after December 31, 2009.
(f) Additional Modifications to Estate Tax.--
(1) In general.--The following provisions of the Economic
Growth and Tax Relief Reconciliation Act of 2001, and the
amendments made by such provisions, are hereby repealed:
(A) Subtitles A and E of title V.
(B) Subsection (d), and so much of subsection
(f)(3) as relates to subsection (d), of section 511.
(C) Paragraph (2) of subsection (b), and paragraph
(2) of subsection (e), of section 521.
The Internal Revenue Code of 1986 shall be applied as if such
provisions and amendments had never been enacted.
(2) Sunset not to apply.--
(A) Subsection (a) of section 901 of the Economic
Growth and Tax Relief Reconciliation Act of 2001 is
amended by striking ''this Act'' and all that follows
and inserting ''this Act (other than title V) shall not
apply to taxable, plan, or limitation years beginning
after December 31, 2010.''.
(B) Subsection (b) of such section 901 is amended
by striking '', estates, gifts, and transfers''.
(3) Repeal of deadwood.--
(A) Sections 2011, 2057, and 2604 of the Internal
Revenue Code of 1986 are hereby repealed.
(B) The table of sections for part II of subchapter
A of chapter 11 of such Code is amended by striking the
item relating to section 2011.
(C) The table of sections for part IV of subchapter
A of chapter 11 of such Code is amended by striking the
item relating to section 2057.
(D) The table of sections for subchapter A of
chapter 13 of such Code is amended by striking the item
relating to section 2604.

SEC. 2. UNIFIED CREDIT INCREASED BY UNUSED UNIFIED CREDIT OF DECEASED
SPOUSE.

(a) In General.--Section 2010(c) of the Internal Revenue Code of
1986, as amended by section 1(b), is amended by striking paragraph (2)
and inserting the following new paragraphs:
''(2) Applicable exclusion amount.--For purposes of this
subsection, the applicable exclusion amount is the sum of--
''(A) the basic exclusion amount, and
''(B) in the case of a surviving spouse, the
aggregate deceased spousal unused exclusion amount.
''(3) Basic exclusion amount.--
''(A) In general.--For purposes of this subsection,
the basic exclusion amount is $3,500,000.
''(B) Inflation adjustment.--In the case of any
decedent dying in a calendar year after 2010, the
dollar amount in subparagraph (A) shall be increased by
an amount equal to--
''(i) such dollar amount, multiplied by
''(ii) the cost-of-living adjustment
determined under section 1(f)(3) for such
calendar year by substituting 'calendar year
2009' for 'calendar year 1992' in subparagraph
(B) thereof.
If any amount as adjusted under the preceding sentence
is not a multiple of $10,000, such amount shall be
rounded to the nearest multiple of $10,000.
''(4) Aggregate deceased spousal unused exclusion amount.--
For purposes of this subsection, the term 'aggregate deceased
spousal unused exclusion amount' means the lesser of--
''(A) the basic exclusion amount, or
''(B) the sum of the deceased spousal unused
exclusion amounts computed with respect to each
deceased spouse of the surviving spouse.
''(5) Deceased spousal unused exclusion amount.--For
purposes of this subsection, the term 'deceased spousal unused
exclusion amount' means, with respect to the surviving spouse
of any deceased spouse dying after December 31, 2009, the
excess (if any) of--
''(A) the basic exclusion amount of the deceased
spouse, over
''(B) the amount with respect to which the
tentative tax is determined under section 2001(b)(1) on
the estate of such deceased spouse.
''(6) Special rules.--
''(A) Election required.--A deceased spousal unused
exclusion amount may not be taken into account by a
surviving spouse under paragraph (5) unless the
executor of the estate of the deceased spouse files an
estate tax return on which such amount is computed and
makes an election on such return that such amount may
be so taken into account. Such election, once made,
shall be irrevocable. No election may be made under
this subparagraph if such return is filed after the
time prescribed by law (including extensions) for
filing such return.
''(B) Examination of prior returns after expiration
of period of limitations with respect to deceased
spousal unused exclusion amount.--Notwithstanding any
period of limitation in section 6501, after the time
has expired under section 6501 within which a tax may
be assessed under chapter 11 or 12 with respect to a
deceased spousal unused exclusion amount, the Secretary
may examine a return of the deceased spouse to make
determinations with respect to such amount for purposes
of carrying out this subsection.
''(7) Regulations.--The Secretary shall prescribe such
regulations as may be necessary or appropriate to carry out
this subsection.''.
(b) Conforming Amendments.--
(1) Paragraph (1) of section 2505(a) of the Internal
Revenue Code of 1986, as amended by section 1(a), is amended to
read as follows:
''(1) the applicable credit amount in effect under section
2010(c) which would apply if the donor died as of the end of
the calendar year, reduced by''.
(2) Section 2631(c) of such Code is amended by striking
''the applicable exclusion amount'' and inserting ''the basic
exclusion amount''.
(3) Section 6018(a)(1) of such Code is amended by striking
''applicable exclusion amount'' and inserting ''basic exclusion
amount''.
(c) Effective Date.--The amendments made by this section shall
apply to estates of decedents dying, generation-skipping transfers, and
gifts made, after December 31, 2009.

SEC. 3. SENSE OF THE SENATE REGARDING REVENUE NEUTRALITY.

It is the sense of the Senate that any reduction in Federal
revenues resulting from the provisions of, and amendments made by, this
Act should be fully offset.
Amends the Internal Revenue Code to: (1) establish a permanent estate tax exclusion of $3.5 million ($7 million for married couples filing joint tax returns) and a maximum 45% tax rate for decedents dying, generation-skipping transfers, and gifts made, after December 31, 2009; (2) allow an annual inflation adjustment to the exclusion amount after 2010; and (3) allow a surviving spouse an increase in the estate tax exclusion by the unused exclusion amount of a deceased spouse.

Expresses the sense of the Senate that any reduction in federal revenues resulting from this Act should be fully offset.

SECTION 1. SHORT TITLE.

This Act may be cited as the ''Improving Physician Access in
Teaching Hospitals (PATH) Act of 2011''.

SEC. 2. DISTRIBUTION OF ADDITIONAL RESIDENCY SLOTS.

Section 1886(h) of the Social Security Act (42 U.S.C. 1395ww(h)) is
amended--
(1) in paragraph (7)(E), by inserting ''paragraph (9),''
after ''paragraph (8),''; and
(2) by adding at the end the following:
''(9) Distribution of additional residency positions.--
''(A) Reductions in limit based on unused
positions.--
''(i) In general.--Except as provided in
clause (ii), if a hospital's resident level (as
defined in paragraph (7)(C)(i)) for each of the
5 most recent cost reporting periods (ending
before the date of the enactment of this
paragraph) of the hospital for which a cost
report has been settled (or, if not, submitted
subject to audit) as determined by the
Secretary is less than the otherwise applicable
resident limit (as defined in paragraph
(8)(H)(iii)), effective for portions of cost
reporting periods occurring on or after the
paragraph (9) effective date (as defined in
subparagraph (E)), the otherwise applicable
resident limit shall be reduced by the
difference between such otherwise applicable
resident limit and the highest such reference
resident level for any of such 5 cost reporting
periods.
''(ii) Exception.--Clause (i) shall not
apply to--
''(I) a hospital located in a rural
area with fewer than 250 beds; or
''(II) a hospital that has had in
effect a voluntary residency reduction
plan under paragraph (6) or pursuant to
section 402 of Public Law 90-248.
''(B) Requirements for additional residency
slots.--
''(i) In general.--The Secretary shall
increase the otherwise applicable resident
limit for hospitals that submit an application
under this subparagraph by such number as the
Secretary may approve for portions of cost
reporting periods occurring on or after the
paragraph (9) effective date. The aggregate
number of increases in the otherwise applicable
resident limit under this subparagraph shall be
equal to the sum of--
''(I) the aggregate reduction in
such limits attributable to
subparagraph (A) (as estimated by the
Secretary); and
''(II) 1,000 for portions of cost
reporting periods occurring during the
12-month period beginning on the
paragraph (9) effective date, 1,000
additional positions for portions of
cost reporting periods occurring during
the 12-month period beginning 1 year
after such effective date, 1,000
additional positions for portion of
cost reporting period occurring during
the 12-month period beginning 2 years
after such effective date, and such
number of additional positions for
portions of the 2 subsequent cost
reporting periods as the Secretary may
determine necessary to support
residency training programs in
specialities that exceed 3 years.
''(ii) Consideration in redistribution.--In
determining for which hospitals the increase in
the otherwise applicable resident limit is
provided under this subparagraph, the Secretary
shall take into account--
''(I) data provided by the Health
Resources and Services Administration
as a national standard to exhibit a
specific demand in the health care
workforce, as well as the
Administration's projected demand and
supply for physicians in the specialty
of medicine involved; and
''(II) the demonstrated likelihood
of the hospital filling positions made
available under this paragraph within
the first 3 cost reporting periods
beginning on or after the paragraph (9)
effective date.
The Secretary shall give special consideration
for up to 25 additional positions in the case
of a hospital that demonstrates the likelihood
of filing such positions during the first cost
reporting period beginning on or after such
effective date.
''(iii) Limitation.--In no case shall the
number of additional positions made available
to a hospital under this paragraph exceed 25 in
the first cost reporting period or 75 for all
cost reporting periods.
''(C) Priority for additional positions resulting
from hospital closures.--With respect to additional
positions described in subparagraph (B)(i)(I) which are
derived from a reduction in limits under subparagraph
(A) for a hospital that closed (in this subparagraph
referred to as a 'closed hospital'), the Secretary
shall distribute the increase to hospitals in the
following priority order:
''(i) First, to other hospitals for the
program or programs under which the hospital
had a cooperative arrangement with the closed
hospital under which residents in the graduate
medical education program of the closed
hospital also rotated through the other
hospital.
''(ii) Second, to other hospitals that are
members of the same affiliated group of
hospitals as the closed hospital.
''(iii) Third, to other hospitals that are
located in the same or contiguous core-based
statistical area as the closed hospital.
''(D) Preference.--After applying subparagraph (C)
and the special consideration under subparagraph (B),
in determining for which hospitals the increase in the
otherwise applicable resident limit is provided under
subparagraph (B), the Secretary shall give preference
to hospitals--
''(i) that submit an application for new
residents in primary care and geriatric
medicine and in other specialties as determined
to be in demand under subparagraph (B)(ii)(I);
and
''(ii) that emphasize training in community
health centers and other community-based or
hospital-sponsored clinics, and private
physicians' offices, including physician
groups.
''(E) Paragraph (9) effective date defined.--In
this paragraph, the term 'paragraph (9) effective date'
means July 1 of the year that begins after the date of
the enactment of this paragraph.
''(F) Affiliation.--The provisions of this
paragraph shall be applied to hospitals which are
members of the same affiliated group (as defined by the
Secretary under paragraph (4)(H)(ii)) and the reference
resident level for each such hospital with respect to
the cost reporting period that results in the smallest
difference between the reference resident level and the
otherwise applicable resident limit.''.

SEC. 3. EXPANDING PRIMARY CARE BONUS TO CERTAIN UNDERSERVED
SPECIALTIES.

(a) In General.--Section 1833(x)(2)(A) of the Social Security Act
(42 U.S.C. 1395l(x)(2)(A)) is amended--
(1) in clause (i)--
(A) by striking ''or'' at the end of subclause (I);
(B) by striking ''and'' at the end of subclause
(II) and inserting ''or''; and
(C) by adding at the end the following new
subclause:
''(III) is a physician (as
described in section 1861(r)(1)) who is
in an underserved specialty, such as
psychiatry or neurology, as specified
by the Secretary, or other specialty
identified by the Secretary to be in
demand; and''; and
(2) in clause (ii), by inserting after ''(ii)'' the
following: ''in the case of an individual described in
subclause (I) or (II) of clause (i),''.
(b) Effective Date.--The amendments made by subsection (a) shall
apply to payments for items and services furnished on or after January
1, 2012.

SEC. 4. SMALL PHYSICIAN PRACTICE RESIDENCY CREDIT.

(a) In General.--Subpart D of part IV of subchapter A of chapter 1
of the Internal Revenue Code of 1986 (relating to business related
credits) is amended by adding at the end the following new section:

''SEC. 45S. SMALL PHYSICIAN PRACTICE RESIDENCY CREDIT.

''(a) In General.--For purposes of section 38, the amount of the
small physician practice residency credit determined under this section
for any taxable year with respect to a qualified small physician
practice is the sum of the following:
''(1) Overall amount.--The per resident dollar amount
multiplied by the number of qualified teaching hospital
residents who provide services to, and are trained by, such
practice during the taxable year and who are in their first,
second, or third post-graduate year of medical residency.
''(2) Bonus.--The sum of--
''(A) 50 percent of the per resident dollar amount
multiplied by the number of such residents who are in
their first post-graduate year of medical residency
during the taxable year; and
''(B) 25 percent of the per resident dollar amount
multiplied by the average number of such residents who
are not counted under subparagraph (A) and are in their
second post-graduate year during the taxable year.
''(b) Qualified Small Physician Practice.--For purposes of this
section, the term 'qualified small physician practice' means any trade
or business of providing physicians' services (as defined in section
1861(q) of the Social Security Act), which may be a community health
center, that is owned and operated by a doctor of medicine or
osteopathy if fewer than 50 individuals are employed in such trade or
business (including new training sites) and the trade or business
includes as part of the practice the training of doctors of medicine or
osteopathy in a rotation covering at least 6 months in the taxable
year. All persons treated as a single employer under subsection (a) or
(b) or section 52 or subsection (m) or (o) of section 414 shall be
treated as a single trade or business for purposes of the preceding
sentence.
''(c) Qualified Teaching Hospital Residents.--For purposes of this
section, the term 'qualified teaching hospital resident' means any
resident (within the meaning of subparagraph (I) of section 1886(h)(5)
of the Social Security Act) in an approved medical residency training
program (as defined in subparagraph (A) of such section) which provides
services to the qualified small physician practice (while utilizing the
technologies and supplies of such practice) for a period not less
than--
''(1) 4 weeks in the case of a primary care resident (as
defined in subparagraph (H) of such section); or
''(2) 2 weeks in the case of any other resident.
''(d) Per Resident Dollar Amount.--For purposes of this section,
the term 'per resident dollar amount' means, in the case of a qualified
small physician practice that includes as part of the practice the
training of doctors of medicine or osteopathy in a rotation covering--
''(1) at least 6 months but less than 9 months in the
taxable year, $2,500; or
''(2) at least 9 months in the taxable year, $3,000.
''(e) Residents Not Taken Into Account More Than Once.--A qualified
teaching hospital resident shall be taken into account under subsection
(a) for the taxable in which the period described in subsection (c)
ends and shall not be so taken into account for any other taxable
year.''.
(b) Credit Allowed as Part of General Business Credit.--Section
38(b) of such Code (defining current year business credit) is amended
by striking ''plus'' at the end of paragraph (35), by striking the
period at the end of paragraph (36) and inserting '', plus'', and by
adding at the end the following new paragraph:
''(37) the small physician practice residency credit
determined under section 45S(a).''.
(c) Conforming Amendment.--The table of sections for subpart D of
part IV of subchapter A of chapter 1 of such Code is amended by adding
at the end the following new item:

''Sec. 45S. Small physician practice residency credit.''.
(d) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after the date of the enactment of
this Act.
Improving Physician Access in Teaching Hospitals (PATH) Act of 2011 - Amends title XVIII (Medicare) of the Social Security Act with respect to distribution of additional resident positions as they affect calculation of payments for direct graduate medical education (DME) costs.

States that, if a hospital's resident level for each of the five most recent cost reporting periods is less than the otherwise applicable resident limit, then the otherwise applicable resident limit shall be reduced by the difference between it and the highest reference resident level for any of those five cost reporting periods. Excepts from this reduction requirement a hospital: (1) located in a rural area with fewer than 250 beds, or (2) that has had in effect a voluntary residency reduction plan.

Requires the Secretary of Health and Human Services (HHS) to increase the otherwise applicable resident limit (create additional residency slots) for applicant hospitals according to a specified formula that takes into account the aggregate reduction in limits attributable to this Act.

Expands the primary care bonus to certain underserved specialties, such as psychiatry or neurology.

Amends the Internal Revenue Code to allow a small physician practice residency credit.

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.
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.