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

SECTION 1. SHORT TITLE.

This Act may be cited as the ''Preservation of Antibiotics for
Medical Treatment Act of 2011''.

SEC. 2. FINDINGS.

The Congress finds the following:
(1) In January 2001, a Federal interagency task force--
(A) released an action plan to address the
continuing decline in effectiveness of antibiotics
against common bacterial infections, referred to as
antibiotic resistance;
(B) determined that antibiotic resistance is a
growing menace to all people and poses a serious threat
to public health; and
(C) cautioned that if current trends continue,
treatments for common infections will become
increasingly limited and expensive, and, in some cases,
nonexistent.
(2) 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 or a large influx of hospitalized
patients.
(3)(A) Any overuse or misuse of antibiotics contributes to
the spread of antibiotic resistance, whether in human medicine
or in agriculture.
(B) Recognizing the public health threat caused by
antibiotic resistance, Congress took several steps to curb
antibiotic overuse in human medicine through amendments to the
Public Health Service Act (42 U.S.C. 201 et seq.) made by
section 102 of the Public Health Threats and Emergencies Act
(Public Law 106-505, title I; 114 Stat. 2315), but has not yet
addressed antibiotic overuse in agriculture.
(4) In a March 2003 report, the National Academy of
Sciences stated that--
(A) a decrease in antimicrobial use in human
medicine alone will have little effect on the current
situation; and
(B) substantial efforts must be made to decrease
inappropriate overuse in animals and agriculture.
(5) In 2010, the FDA determined that--
(A) 13.1 million kilograms of antibacterial drugs
were sold for use on food animals in the United States
in 2009;
(B) 3.3 million kilograms of antibacterial drugs
were used for human health in 2009; and
(C) therefore, 80 percent of antibacterial drugs
disseminated in the United States in 2009 were sold for
use on food animals, rather than being used for human
health.
(6)(A) Large-scale, voluntary surveys by the Department of
Agriculture's Animal and Plant Health Inspection Service in
1999, 2001, and 2006 revealed that--
(i) 84 percent of grower-finisher swine farms, 83
percent of cattle feedlots, and 84 percent of sheep
farms administer antimicrobials in the feed or water
for health or growth promotion reasons; and
(ii) many of the antimicrobials identified are
identical or closely related to drugs used in human
medicine, including tetracyclines, macrolides,
Bacitracin, penicillins, and sulfonamides; and
(B) these drugs are used in people to treat serious
diseases such as pneumonia, scarlet fever, rheumatic fever,
venereal disease, skin infections, and even pandemics like
malaria and plague, as well as bioterrorism agents like
smallpox and anthrax.
(7) Many scientific studies confirm that the nontherapeutic
use of antibiotics in agricultural animals contributes to the
development of antibiotic-resistant bacterial infections in
people.
(8) The periodical entitled ''Clinical Infectious
Diseases'' published a report in June 2002, that--
(A) was based on a 2-year review by experts in
human and veterinary medicine, public health,
microbiology, biostatistics, and risk analysis, of more
than 500 scientific studies on the human health impacts
of antimicrobial use in agriculture; and
(B) recommended that antimicrobial agents should no
longer be used in agriculture in the absence of
disease, but should be limited to therapy for diseased
individual animals and prophylaxis when disease is
documented in a herd or flock.
(9) The United States Geological Survey reported in March
2002 that--
(A) antibiotics were present in 48 percent of the
streams tested nationwide; and
(B) almost half of the tested streams were
downstream from agricultural operations.
(10) An April 1999 study by the General Accounting Office
concluded that resistant strains of 3 microorganisms that cause
food-borne illness or disease in humans (Salmonella,
Campylobacter, and E. coli) are linked to the use of
antibiotics in animals.
(11) Epidemiological research has shown that resistant
Salmonella and Campylobacter infections are associated with
increased numbers of ill patients and bloodstream infections,
and increased death.
(12) In 2010, the peer-reviewed journal Molecular Cell
published a study demonstrating that low-dosage use of
antibiotics causes a dramatic increase in genetic mutation,
raising new concerns about the agricultural practice of using
low-dosage antibiotics in order to stimulate growth promotion
and routinely prevent disease in unhealthy conditions.
(13)(A) In January 2003, Consumer Reports published test
results on poultry products bought in grocery stores nationwide
showing disturbingly high levels of Campylobacter and
Salmonella bacteria that were resistant to the antibiotics used
to treat food-borne illnesses.
(B) The Food and Drug Administration's National
Antimicrobial Resistance Monitoring System routinely finds that
retail meat products are contaminated with bacteria (including
the foodborne pathogens Campylobacter and Salmonella) that are
resistant to antibiotics important in human medicine.
(C) In December 2007, the USDA issued a fact sheet on the
recently recognized link between antimicrobial drug use in
animals and Methicillin Resistant Staphylococcus Aureas (MRSA)
infections in humans.
(14) In October 2001, the New England Journal of Medicine
published an editorial urging a ban on nontherapeutic use of
medically important antibiotics in animals.
(15)(A) In 1998, the National Academy of Sciences noted
that antibiotic-resistant bacteria generate a minimum of
$4,000,000,000 to $5,000,000,000 in costs to United States
society and individuals yearly.
(B) In 2009, Cook County Hospital and the Alliance for
Prudent Use of Antibiotics estimated that the total health care
cost of antibiotic resistant infections in the United States
was between $16,600,000,000 and $26,000,000,000 annually.
(16) The American Medical Association, the American Public
Health Association, the National Association of County and City
Health Officials, and the National Campaign for Sustainable
Agriculture are among the more than 300 organizations
representing health, consumer, agricultural, environmental,
humane, and other interests that have supported enactment of
legislation to phase out nontherapeutic use in farm animals of
medically important antibiotics.
(17) In 2010, the Danish Veterinary and Food Administration
testified that the Danish ban of the non-therapeutic use of
antibiotics in food animal production resulted in a marked
reduction in antimicrobial resistance in multiple bacterial
species, including Campylobacter and Enterococci.
(18) In 2009, the Congressional Research Service concluded
that restrictions overseas on the use of antimicrobial drugs in
the production of livestock could impact U.S. export markets
for livestock and poultry.
(19) The Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.)--
(A) requires that all drugs be shown to be safe
before the drugs are approved; and
(B) places the burden on manufacturers to account
for health consequences and prove safety.
(20)(A) The Food and Drug Administration recently 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.
(21) Certain non-routine uses of antibiotics in animal
agriculture are legitimate to prevent animal disease.
(22) An April 2004 study by the General Accounting Office--
(A) concluded that Federal agencies do not collect
the critical data on antibiotic use in animals that
they need to support research on human health risks;
and
(B) recommends that the Department of Agriculture
and the Department of Health and Human Services develop
and implement a plan to collect data on antibiotic use
in animals.

SEC. 3. PURPOSE.

The purpose of this Act is to preserve the effectiveness of
medically important antibiotics used in the treatment of human and
animal diseases by reviewing the safety of certain antibiotics for
nontherapeutic purposes in food-producing animals.

SEC. 4. PROOF OF SAFETY OF CRITICAL ANTIMICROBIAL ANIMAL DRUGS.

(a) Definitions.--Section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the
following:
''(ss) Critical Antimicrobial Animal Drug.--The term 'critical
antimicrobial animal drug' means a drug that--
''(1) is intended for use in food-producing animals; and
''(2) is composed wholly or partly of--
''(A) any kind of penicillin, tetracycline,
macrolide, lincosamide, streptogramin, aminoglycoside,
or sulfonamide; or
''(B) any other drug or derivative of a drug that
is used in humans or intended for use in humans to
treat or prevent disease or infection caused by
microorganisms.
''(tt) Nontherapeutic Use.--The term 'nontherapeutic use', with
respect to a critical antimicrobial animal drug, means any use of the
drug as a feed or water additive for an animal in the absence of any
clinical sign of disease in the animal for growth promotion, feed
efficiency, weight gain, routine disease prevention, or other routine
purpose.''.
(b) 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 critical antimicrobial
animal drug or a drug of the same chemical class as a
critical antimicrobial animal drug, 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 of the drug; or''; and
(2) in the second sentence, by striking ''(A) through (I)''
and inserting ''(A) through (J)''.
(c) Phased Elimination of Nontherapeutic Use in Animals of Critical
Antimicrobial Animal Drugs Important for Human Health.--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
Critical Antimicrobial Animal Drugs Important for Human Health.--
''(1) Applicability.--This subsection applies to the
nontherapeutic use in a food-producing animal of a drug--
''(A)(i) that is a critical antimicrobial animal
drug; or
''(ii) that is of the same chemical class as a
critical antimicrobial animal drug; and
''(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 use.
''(2) Withdrawal.--The Secretary shall withdraw the
approval of a nontherapeutic use in food-producing animals
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 critical antimicrobial animal drug, the
Secretary shall rescind each approval of a nontherapeutic use
in a food-producing animal of the critical antimicrobial animal
drug, or of a drug in the same chemical class as the critical
antimicrobial animal drug, 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 critical antimicrobial
animal drug 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 critical antimicrobial
animal drug, or of a drug in the same chemical class as the
critical antimicrobial animal drug, as of the date that is 2
years after the date on which the application is submitted to
the Secretary.
''(5) Exception.--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 critical antimicrobial animal
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 critical antimicrobial animal drug 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 drug.''.

SEC. 5. COMMITTEE HEARINGS ON IMPLEMENTATION.

(a) In General.--The Committee on Energy and Commerce of the House
of Representatives and the Committee on Energy of the Senate shall each
hold a hearing on the implementation by the Commissioner of Food and
Drugs of section 512(q) of the Federal Food, Drug, and Cosmetic Act, as
added by section 4 of this Act.
(b) Exercise of Rulemaking Authority.--Subsection (a) is enacted--
(1) as an exercise of the rulemaking power of the House of
Representatives and Senate, and, as such, they shall be
considered as part of the rules of the House or Senate (as the
case may be), and such rules shall supersede any other rule of
the House or Senate only to the extent that rule is
inconsistent therewith; and
(2) with full recognition of the constitutional right of
either House to change such rules (so far as relating to the
procedure in such House) at any time, in the same manner, and
to the same extent as in the case of any other rule of the
House or Senate.
Preservation of Antibiotics for Medical Treatment Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to deny an application for a new animal drug that is a critical antimicrobial animal drug unless the applicant demonstrates that there is a reasonably certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Defines "critical antimicrobial animal drug" as a drug intended for use in food-producing animals that contains specified antibiotics or other drugs used in humans to treat or prevent disease or infection caused by microorganisms.

Requires the Secretary to withdraw approval of a nontherapeutic use of such drugs in food-producing animals two years after the date of enactment of this Act unless certain safety requirements are met. Directs specified congressional committees to hold hearings on the implementation of such a withdrawal of approval.

SECTION 1. SHORT TITLE.

This Act may be cited as the ''Medical Devices Technical
Corrections Act''.

SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC LAW 107-250.

(a) Title I; Fees Relating to Medical Devices.--Part 3 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379i et seq.), as added by section 102 of Public Law 107-250
(116 Stat. 1589), is amended--
(1) in section 737--
(A) in paragraph (4)(B), by striking ''and for which
clinical data are generally necessary to provide a reasonable
assurance of safety and effectiveness'' and inserting ''and for
which substantial clinical data are necessary to provide a
reasonable assurance of safety and effectiveness'';
(B) in paragraph (4)(D), by striking ''manufacturing,'';
(C) in paragraph (5)(J), by striking ''a premarket
application'' and all that follows and inserting ''a premarket
application or premarket report under section 515 or a
premarket application under section 351 of the Public Health
Service Act.''; and
(D) in paragraph (8), by striking ''The term 'affiliate'
means a business entity that has a relationship with a second
business entity'' and inserting ''The term 'affiliate' means a
business entity that has a relationship with a second business
entity (whether domestic or international)''; and
(2) in section 738--
(A) in subsection (a)(1)--
(i) in subparagraph (A)--

(I) in the matter preceding clause (i) by striking
''subsection (d),'' and inserting ''subsections (d) and
(e),'';
(II) in clause (iv), by striking ''clause (i),''
and all that follows and inserting ''clause (i).''; and
(III) in clause (vii), by striking ''clause (i),''
and all that follows and inserting ''clause (i),
subject to any adjustment under subsection
(e)(2)(C)(ii).''; and

(ii) in subparagraph (D), in each of clauses (i) and
(ii), by striking ''application'' and inserting
''application, report,'';
(B) in subsection (d)(2)(B), beginning in the second
sentence, by striking ''firms. which show'' and inserting
''firms, which show'';
(C) in subsection (e)--
(i) in paragraph (1), by striking ''Where'' and
inserting ''For fiscal year 2004 and each subsequent fiscal
year, where''; and
(ii) in paragraph (2)--

(I) in subparagraph (B), beginning in the second
sentence, by striking ''firms. which show'' and
inserting ''firms, which show''; and
(II) in subparagraph (C)(i), by striking ''Where''
and inserting ''For fiscal year 2004 and each
subsequent fiscal year, where'';

(D) in subsection (f), by striking ''for filing''; and
(E) in subsection (h)(2)(B)--
(i) in clause (ii), by redesignating subclauses (I) and
(II) as items (aa) and (bb), respectively;
(ii) by redesignating clauses (i) and (ii) as
subclauses (I) and (II), respectively;
(iii) by striking ''The Secretary'' and inserting the
following:
''(i) In general.--The Secretary''; and
(iv) by adding at the end the following:
''(ii) More than 5 percent.--To the extent such costs
are more than 5 percent below the specified level in
subparagraph (A)(ii), fees may not be collected under this
section for that fiscal year.''.
(b) Title II; Amendments Regarding Regulation of Medical Devices.--
(1) Inspections by accredited persons.--Section 704(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)), as added
by section 201 of Public Law 107-250 (116 Stat. 1602), is amended--
(A) in paragraph (1), in the first sentence, by striking
''conducting inspections'' and all that follows and inserting
''conducting inspections of establishments that manufacture,
prepare, propagate, compound, or process class II or class III
devices, which inspections are required under section 510(h) or
are inspections of such establishments required to register
under section 510(i).'';
(B) in paragraph (5)(B), in the first sentence, by striking
''or poses'' and all that follows through the period and
inserting ''poses a threat to public health, fails to act in a
manner that is consistent with the purposes of this subsection,
or where the Secretary determines that there is a financial
conflict of interest in the relationship between the accredited
person and the owner or operator of a device establishment that
the accredited person has inspected under this subsection.'';
(C) in paragraph (6)(A)--
(i) in clause (i), by striking ''of the establishment
pursuant to subsection (h) or (i) of section 510'' and
inserting ''described in paragraph (1)'';
(ii) in clause (ii)--

(I) in the matter preceding subclause (I)--

(aa) by striking ''each inspection'' and
inserting ''inspections''; and
(bb) by inserting ''during a 2-year period''
after ''person''; and

(II) in subclause (I), by striking ''such a
person'' and inserting ''an accredited person'';

(iii) in clause (iii)--

(I) in the matter preceding subclause (I), by
striking ''and the following additional conditions are
met:'' and inserting ''and 1 or both of the following
additional conditions are met:'';
(II) in subclause (I), by striking ''accredited''
and all that follows through the period and inserting
''(accredited under paragraph (2) and identified under
clause (ii)(II)) as a person authorized to conduct such
inspections of device establishments.''; and
(III) in subclause (II), by inserting ''or by a
person accredited under paragraph (2)'' after ''by the
Secretary'';

(iv) in clause (iv)(I)--

(I) in the first sentence--

(aa) by striking ''the two immediately
preceding inspections of the establishment'' and
inserting ''inspections of the establishment during
the previous 4 years''; and
(bb) by inserting ''section'' after ''pursuant
to'';

(II) in the third sentence--

(aa) by striking ''the petition states a
commercial reason for the waiver;''; and
(bb) by inserting ''not'' after ''the Secretary
has not determined that the public health would'';
and

(III) in the fourth sentence, by striking ''granted
until'' and inserting ''granted or deemed to be granted
until''; and

(v) in clause (iv)(II)--

(I) by inserting ''of a device establishment
required to register'' after ''to be conducted''; and
(II) by inserting ''section'' after ''pursuant
to'';

(D) in paragraph (6)(B)(iii)--
(i) in the first sentence, by striking '', and data
otherwise describing whether the establishment has
consistently been in compliance with sections 501 and 502
and other'' and inserting ''and with other''; and
(ii) in the second sentence--

(I) by striking ''inspections'' and inserting
''inspectional findings''; and
(II) by inserting ''relevant'' after ''together
with all other'';

(E) in paragraph (6)(B)(iv)--
(i) by inserting ''(I)'' after ''(iv)''; and
(ii) by adding at the end the following:
''(II) If, during the two-year period following clearance under
subparagraph (A), the Secretary determines that the device
establishment is substantially not in compliance with this Act, the
Secretary may, after notice and a written response, notify the
establishment that the eligibility of the establishment for the
inspections by accredited persons has been suspended.'';
(F) in paragraph (6)(C)(ii), by striking ''in accordance
with section 510(h), or has not during such period been
inspected pursuant to section 510(i), as applicable'';
(G) in paragraph (10)(B)(iii), by striking ''a reporting''
and inserting ''a report''; and
(H) in paragraph (12)--
(i) by striking subparagraph (A) and inserting the
following:
''(A) the number of inspections conducted by accredited persons
pursuant to this subsection and the number of inspections conducted
by Federal employees pursuant to section 510(h) and of device
establishments required to register under section 510(i);''; and
(ii) in subparagraph (E), by striking ''obtained by the
Secretary'' and all that follows and inserting ''obtained
by the Secretary pursuant to inspections conducted by
Federal employees;''.
(2) Other corrections.--
(A) Prohibited acts.--Section 301(gg) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(gg)), as amended by
section 201(d) of Public Law 107-250 (116 Stat. 1609), is
amended to read as follows:
''(gg) The knowing failure to comply with paragraph (7)(E) of
section 704(g); the knowing inclusion by a person accredited under
paragraph (2) of such section of false information in an inspection
report under paragraph (7)(A) of such section; or the knowing failure
of such a person to include material facts in such a report.''.
(B) Electronic labeling.--Section 502(f) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)), as amended by
section 206 of Public Law 107-250 (116 Stat. 1613), is amended,
in the last sentence--
(i) by inserting ''or by a health care professional and
required labeling for in vitro diagnostic devices intended
for use by health care professionals or in blood
establishments'' after ''in health care facilities'';
(ii) by inserting a comma after ''means'';
(iii) by striking ''requirements of law and, that'' and
inserting ''requirements of law, and that'';
(iv) by striking ''the manufacturer affords health care
facilities the opportunity'' and inserting ''the
manufacturer affords such users the opportunity''; and
(v) by striking ''the health care facility''.
(c) Title III; Additional Amendments.--
(1) Effective date.--Section 301(b) of Public Law 107-250 (116
Stat. 1616), is amended by striking ''18 months'' and inserting
''36 months''.
(2) Premarket notification.--Section 510(o) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360(o)), as added by
section 302(b) of Public Law 107-250 (116 Stat. 1616), is amended--
(A) in paragraph (1)(B), by striking '', adulterated'' and
inserting ''or adulterated''; and
(B) in paragraph (2)--
(i) in subparagraph (B), by striking '', adulterated''
and inserting ''or adulterated''; and
(ii) in subparagraph (E), by striking ''semicritical''
and inserting ''semi-critical''.
(d) Miscellaneous Corrections.--
(1) Certain amendments to section 515.--
(A) In general.--
(i) Technical correction.--Section 515(c) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)),
as amended by sections 209 and 302(c)(2)(A) of Public Law
107-250 (116 Stat. 1613, 1618), is amended by redesignating
paragraph (3) (as added by section 209 of such Public Law)
as paragraph (4).
(ii) Modular review.--Section 515(c)(4)(B) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360e(c)(4)(B)) is amended by striking ''unless an issue of
safety'' and inserting ''unless a significant issue of
safety''.
(B) Conforming amendment.--Section 210 of Public Law 107-
250 (116 Stat. 1614) is amended by striking
'', as amended'' and all that follows through ''by adding'' and
inserting ''is amended in paragraph (3), as redesignated by
section 302(c)(2)(A) of this Act, by adding''.
(2) Certain amendments to section 738.--
(A) In general.--Section 738(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j(a)), as amended by subsection
(a), is amended--
(i) in the matter preceding paragraph (1)--

(I) by striking ''(a) Types of Fees.--Beginning
on'' and inserting the following:

''(a) Types of Fees.--
''(1) In general.--Beginning on''; and

(II) by striking ''this section as follows:'' and
inserting ''this section.''; and

(ii) by striking ''(1) Premarket application,'' and
inserting the following: ''(2) Premarket application,''.
(B) Conforming amendments.--Section 738 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as amended by
subparagraph (A), is amended--
(i) in subsection (d)(1), in the last sentence, by
striking ''subsection (a)(1)(A)'' and inserting
''subsection (a)(2)(A)'';
(ii) in subsection (e)(1), by striking ''subsection
(a)(1)(A)(vii)'' and inserting ''subsection
(a)(2)(A)(vii)'';
(iii) in subsection (e)(2)(C)--

(I) in each of clauses (i) and (ii), by striking
''subsection (a)(1)(A)(vii)'' and inserting
''subsection (a)(2)(A)(vii)''; and
(II) in clause (ii), by striking ''subsection
(a)(1)(A)(i)'' and inserting ''subsection
(a)(2)(A)(i)''; and

(iv) in subsection (j), by striking ''subsection
(a)(1)(D),'' and inserting ''subsection (a)(2)(D),''.
(C) Additional conforming amendment.--Section 102(b)(1) of
Public Law 107-250 (116 Stat. 1600) is amended, in the matter
preceding subparagraph (A), by striking ''section
738(a)(1)(A)(ii)'' and inserting ''section 738(a)(2)(A)(ii)''.
(3) Public law 107-250.--Public Law 107-250 is amended--
(A) in section 102(a) (116 Stat. 1589), by striking ''(21
U.S.C. 379F et seq.)'' and inserting ''(21 U.S.C. 379f et
seq.)'';
(B) in section 102(b) (116 Stat. 1600)--
(i) by striking paragraph (2);
(ii) in paragraph (1), by redesignating subparagraphs
(A) and (B) as paragraphs (1) and (2), respectively; and
(iii) by striking:
''(b) Fee Exemption for Certain Entities Submitting Premarket
Reports.--
''(1) In general.--A person submitting a premarket report'' and
inserting:
''(b) Fee Exemption for Certain Entities Submitting Premarket
Reports.--A person submitting a premarket report''; and
(C) in section 212(b)(2) (116 Stat. 1614), by striking '',
such as phase IV trials,''.
SEC. 3. REPORT ON BARRIERS TO AVAILABILITY OF DEVICES INTENDED FOR
CHILDREN.
Not later than 180 days after the date of enactment of this Act,
the Secretary of Health and Human Services shall submit to the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives a
report on the barriers to the availability of devices intended for the
treatment or diagnosis of diseases and conditions that affect children.
The report shall include any recommendations of the Secretary of Health
and Human Services for changes to existing statutory authority,
regulations, or agency policy or practice to encourage the invention
and development of such devices.

Speaker of the House of Representatives.

Vice President of the United States and
President of the Senate.
Medical Devices Technical Corrections Act - Amends the Federal Food, Drug, and Cosmetic Act (as amended by the Medical Device User Fee and Modernization Act of 2002) to revise provisions concerning medical devices user fees.

Prohibits the Secretary of Health and Human Services from collecting fees to defray costs in any fiscal year where the amount appropriated is more than five percent below the costs of the resources allocated for the review of device applications.

Allows the Secretary to withdraw accreditation to inspect from any person where the Secretary determines that there is a conflict of interest between the company and the accredited inspector.

Permits a company that markets at least one medical device in the United States and one medical device in another country to use an accredited third party inspector if the company certifies that the foreign country recognizes inspections by: (1) the Food and Drug Administration (FDA); and/or (2) the third party inspector. (Current law requires a country to recognize both types of inspections.)

Allows the Secretary to withdraw eligibility for third party inspections from a company if the Secretary determines that the company is substantially not in compliance with the Act.

Allows electronic labeling for prescription devices intended for use by health care professionals and for in vitro diagnostic devices intended for use by health care professionals or in blood establishments.

Delays by 18 additional months the effective date of the provision deeming a device misbranded if the identification of the manufacturer is not conspicuously displayed.

Directs the Secretary to submit a report to the relevant committees on the barriers to the availability of devices intended for treatment or diagnosis of diseases or conditions that affect children.

SECTION 1. SHORT TITLE.

This Act may be cited as the ''Ensuring Medicaid Provides
Opportunities for Widespread Equity, Resources, and Care Act'' or the
''EMPOWER Care Act''.

SEC. 2. EXTENSION OF DEMONSTRATION.

(a) Funding.--Section 6071(h) of the Deficit Reduction Act of 2005
(42 U.S.C. 1396a note) is amended--
(1) in paragraph (1)--
(A) in subparagraph (D), by striking ''and'' after
the semicolon;
(B) in subparagraph (E), by striking the period at
the end and inserting ''; and''; and
(C) by adding at the end the following:
''(F) $450,000,000 for each of fiscal years 2018
through 2022.''; and
(2) in paragraph (2), by striking ''2016'' and inserting
''2022''.
(b) Research and Evaluation.--Section 6071(g) of the Deficit
Reduction Act of 2005 (42 U.S.C. 1396a note) is amended--
(1) in paragraph (2), by striking ''2016'' and inserting
''2022''; and
(2) in paragraph (3), by inserting ''and for each of fiscal
years 2018 through 2022,'' after ''2016,''.

SEC. 3. CHANGES TO INSTITUTIONAL RESIDENCY PERIOD REQUIREMENT.

Section 6071(b)(2) of the Deficit Reduction Act of 2005 (42 U.S.C.
1396a note) is amended--
(1) in subparagraph (A)(i), by striking ''90'' and
inserting ''60''; and
(2) by striking the flush sentence after subparagraph (B).

SEC. 4. UPDATES TO STATE APPLICATION REQUIREMENTS.

Section 6071(c) of the Deficit Reduction Act of 2005 (42 U.S.C.
1396a note) is amended--
(1) in paragraph (3), by striking '', which shall include''
and all that follows through ''2007'';
(2) in paragraph (7)--
(A) in the paragraph heading, by striking
''Rebalancing'' and inserting ''Expenditures''; and
(B) in subparagraph (B)--
(i) in clause (i), by striking ''and''
after the semicolon;
(ii) in clause (ii), by striking the period
at the end and inserting a semicolon; and
(iii) by adding at the end the following:
''(iii) include a work plan that describes for each
Federal fiscal year that occurs during the proposed MFP
demonstration project--
''(I) the use of grant funds for each
proposed initiative that is designed to
accomplish the objective described in
subsection (a)(1), including a funding source
for each activity that is part of each such
proposed initiative;
''(II) an evaluation plan that identifies
expected results for each such proposed
initiative; and
''(III) a sustainability plan for
components of such proposed initiatives that
are intended to improve transitions, which
shall be updated with actual expenditure
information for each Federal fiscal year that
occurs during the MFP demonstration project;
and
''(iv) contain assurances that grant funds used to
accomplish the objective described in subsection (a)(1)
shall be obligated not later than 24 months after the
date on which the funds are awarded and shall be
expended not later than 60 months after the date on
which the funds are awarded (unless the Secretary
approves a waiver of either such requirement).''; and
(3) in paragraph (13)--
(A) in subparagraph (A), by striking ''; and'' and
inserting '', and in such manner as will meet the
reporting requirements set forth for the Transformed
Medicaid Statistical Management Information System (T-
MSIS);'';
(B) by redesignating subparagraph (B) as
subparagraph (D); and
(C) by inserting after subparagraph (A) the
following:
''(B) the State shall report on a quarterly basis
on the use of grant funds by distinct activity, as
described in the approved work plan, and by specific
population as targeted by the State;
''(C) if the State fails to report the information
required under subparagraph (B), fails to report such
information on a quarterly basis, or fails to make
progress under the approved work plan, the State shall
implement a corrective action plan and any lack of
progress under the approved work plan may result in
withholding of grant funds made available to the State;
and''.

SEC. 5. FUNDING FOR QUALITY ASSURANCE AND IMPROVEMENT; TECHNICAL
ASSISTANCE; OVERSIGHT.

Section 6071(f) of the Deficit Reduction Act of 2005 (42 U.S.C.
1396a note) is amended by striking paragraph (2) and inserting the
following:
''(2) Funding.--From the amounts appropriated under
subsection (h)(1)(F) for each of fiscal years 2018 through
2022, $1,000,000 shall be available to the Secretary for each
such fiscal year to carry out this subsection.''.

SEC. 6. BEST PRACTICES EVALUATION.

Section 6071 of the Deficit Reduction Act of 2005 (42 U.S.C. 1396a
note) is amended by adding at the end the following:
''(i) Best Practices.--
''(1) Report.--The Secretary, directly or through grant or
contract, shall submit a report to the President and Congress
not later than September 30, 2020, that contains findings and
conclusions on best practices from the State MFP demonstration
projects carried out with grants made under this section. The
report shall include information and analyses with respect to
the following:
''(A) The most effective State strategies for
transitioning beneficiaries from institutional to
qualified community settings carried out under the
State MFP demonstration projects and how such
strategies may vary for different types of
beneficiaries, such as beneficiaries who are aged,
physically disabled, intellectually or developmentally
disabled, or individuals with serious mental illnesses,
and other targeted waiver beneficiary populations.
''(B) The most common and the most effective State
uses of grant funds carried out under the State MFP
demonstration projects for transitioning beneficiaries
from institutional to qualified community settings and
improving health outcomes, including differentiating
funding for current initiatives that are designed for
such purpose and funding for proposed initiatives that
are designed for such purpose.
''(C) The most effective State approaches carried
out under State MFP demonstration projects for
improving person-centered care and planning.
''(D) Identification of program, financing, and
other flexibilities available under the State MFP
demonstration projects, that are not available under
the traditional Medicaid program, and which directly
contributed to successful transitions and improved
health outcomes under the State MFP demonstration
projects.
''(E) State strategies and financing mechanisms for
effective coordination of housing financed or supported
under State MFP demonstration projects with local
housing authorities and other resources.
''(F) Effective State approaches for delivering
Money Follows the Person transition services through
managed care entities.
''(G) Other best practices and effective transition
strategies demonstrated by States with approved MFP
demonstration projects, as determined by the Secretary.
''(H) Identification and analyses of opportunities
and challenges to integrating effective Money Follows
the Person practices and State strategies into the
traditional Medicaid program.
''(2) Collaboration.--In preparing the report required
under this subsection, the Secretary shall collect and
incorporate information from States with approved MFP
demonstration projects and beneficiaries participating in such
projects, and providers participating in such projects.
''(3) Funding.--From the amounts appropriated under
subsection (h)(1) for each of fiscal years 2017 through 2019,
not more than $300,000 shall be available to the Secretary for
each such fiscal year to carry out this subsection.''.

SEC. 7. MACPAC REPORT ON QUALIFIED SETTINGS CRITERIA.

Section 6071 of the Deficit Reduction Act of 2005 (42 U.S.C. 1396a
note), as amended by section 6, is amended by adding at the end the
following:
''(j) MACPAC Report.--Prior to the final implementation date
established by the Secretary for the criteria established for home and
community-based settings in section 441.301(c)(4) of title 42, Code of
Federal Regulations, as part of final implementation of the Home and
Community Based Services (HCBS) Final Rule published on January 16,
2014 (79 Fed. Reg. 2947)) (referred to in this subsection as the 'HCBS
final rule'), the Medicaid and CHIP Payment and Access Commission
(MACPAC) shall submit to Congress a report that--
''(1) identifies the types of home and community-based
settings and associated services that are available to eligible
individuals in both the MFP demonstration program and sites in
compliance with the HCBS final rule, including regional
variation in the type and accessibility of such settings; and
''(2) recommends policies to align the criteria for a
qualified residence under subsection (b)(6) (as in effect on
October 1, 2017) with the criteria in the HCBS final rule.''.

SEC. 8. TECHNICAL AMENDMENT.

Section 6071(b) of the Deficit Reduction Act of 2005 (42 U.S.C.
1396a note) is amended by adding at the end the following:
''(10) Secretary.--The term 'Secretary' means the Secretary
of Health and Human Services.''.

SEC. 9. EFFECTIVE DATES; APPLICATION TO CURRENT PROJECTS.

(a) Effective Dates.--
(1) In general.--Except as provided in paragraph (2), the
amendments made by this Act shall take effect as if enacted on
October 1, 2017.
(2) Changes to institutional residency period
requirement.--The amendments made by section 3 shall take
effect on the date that is 30 days after the date of enactment
of this Act.
(b) Application to Current Projects.--Not later than 1 year after
the date of enactment of this Act, any State with an approved MFP
demonstration project under section 6071 of the Deficit Reduction Act
of 2005 (42 U.S.C. 1396a note) on the date of enactment of this Act
shall submit a revised application to the Secretary that contains the
same information and assurances as are required for any new State
applicant under the amendments made by this Act.
Ensuring Medicaid Provides Opportunities for Widespread Equity, Resources, and Care Act or the EMPOWER Care Act This bill amends the Deficit Reduction Act of 2005 to extendfundingthroughFY2022 forthe Money Follows the Person Rebalancing Demonstration Program and to otherwise revise the program. (Under this program, the Centers for Medicare & Medicaid Services must award grants to state Medicaid programs to assist in rebalancing states' long-term care systems.)