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

Example input: 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.
Example output: 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.
Example explanation: 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.
Q: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Making Pharmaceutical Markets More
Competitive Act''.

TITLE I--REMOVING REGULATORY BARRIERS TO COMPETITION

SEC. 101. IMPROVING ACCESS TO GENERIC DRUGS.

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) is amended by adding at the end the following:
''(11)(A) The Secretary shall prioritize the review of, and act
within 240 calendar days of the date of the submission of, an original
abbreviated new drug application submitted for review under this
subsection, or on a supplement to such an application, that is for a
drug--
''(i) for which there are not more than 3 approved drugs
listed under paragraph (7), except that the review of an
application submitted more than 30 months in advance of the
last applicable expiration date for a patent for which a
certification under paragraph (2)(A)(vii)(III) has been
submitted, or of the expiration date for an applicable period
of exclusivity under this Act, will not be expedited; or
''(ii) that has been included on the list under section
506E.
''(B) The Secretary shall require the applicant, not later than 60
days prior to the submission of an application described in
subparagraph (A), to provide complete, accurate information regarding
facilities involved in manufacturing processes and testing, including
facilities in corresponding Type II active pharmaceutical ingredients
drug master files submitted with an application and sites or
organizations involved in bioequivalence and clinical studies used to
support the application, in order to make a determination regarding
whether an inspection of an establishment is necessary.
''(C) The Secretary may expedite an inspection or reinspection
under section 704 of an establishment that proposes to manufacture a
drug described in subparagraph (A).
''(D) Nothing in this paragraph shall prevent the Secretary from
prioritizing the review of other applications as the Secretary
determines appropriate.
''(12) The Secretary shall provide review status updates to
applicants regarding applications under this subsection, as
appropriate, including when the application is awaiting final
regulatory action by the office charged with review.
''(13) The Secretary shall publish on the Internet website of the
Food and Drug Administration a list of all drugs approved under
subsection (b) for which all patents and periods of exclusivity under
this Act have expired. Such list shall be updated at least once every
180 days.''.

SEC. 102. REPORTING ON PENDING GENERIC DRUG APPLICATIONS, PRIORITY
REVIEW APPLICATIONS, AND INSPECTIONS.

(a) In General.--Not later than 180 calendar days after the date of
enactment of this Act, and quarterly thereafter until October 1, 2022,
the Secretary of Health and Human Services (referred to in this section
as the ''Secretary'') shall post on the Internet website of the Food
and Drug Administration a report that provides--
(1) the number of applications filed under section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
awaiting action by the applicant, including such applications
that were filed prior to October 1, 2014;
(2) the number of applications filed under section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
awaiting action by the Secretary, including such applications
that were filed prior to October 1, 2014;
(3) the number of applications filed under section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
and prior approval supplements withdrawn in each month covered
by the report;
(4) the mean and median approval and tentative approval
times for applications covered by the report;
(5) the number of applications described in paragraphs (1),
(2), and (3) that are subject to priority review; and
(6) the number of such applications on which the Secretary
has taken action pursuant to section 506H(b) of the Federal
Food, Drug, and Cosmetic Act, as added by section 101.
(b) Annual Report on Priority Review Applications.--
(1) In general.--The Secretary shall submit to the
Committee on Health, Education, Labor, and Pensions and the
Special Committee on Aging of the Senate and the Committee on
Energy and Commerce of the House of Representatives an annual
report, not later than March 31 of each year, on the following:
(A) The number of applications filed under section
505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) that are subject to priority review
during the most recent calendar year and are awaiting
action by the applicant.
(B) The number of applications filed under section
505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) that are subject to priority review
during the most recent calendar year and are awaiting
action by the Secretary.
(C) The number of applications filed under section
505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) that are subject to priority review
during the most recent calendar year and have been
approved by the Secretary.
(D) For each of subparagraphs (A) through (C), the
number of such applications--
(i) for which there are not more than 3
approved drugs listed under section 505(j)(7)
of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(7)); and
(ii) the number of such applications that
are for a drug on the drug shortage list under
section 506E of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356e).
(c) Annual Report on Inspections.--Not later than March 1 of each
year, the Secretary shall post on the Internet website of the Food and
Drug Administration--
(1) the average and median amount of time, following a
request by staff of the Food and Drug Administration reviewing
an application or report submitted under an applicable section
described in subparagraph (A), (B), or (C), to schedule and
complete inspections of facilities necessary for--
(A) approval of a drug under section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
(B) approval of a device under section 515 of such
Act (21 U.S.C. 360e); and
(C) clearance of a device under section 510(k) of
such Act (21 U.S.C. 360(k)); and
(2) the average and median amount of time to schedule and
complete for-cause inspections of facilities of drugs and
devices.

TITLE II--INCENTIVIZING COMPETITION

SEC. 201. EXPEDITING GENERIC COMPETITION.

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351 et seq.) is amended by inserting after section 506G the following:

''SEC. 506H. EXPEDITING GENERIC DRUG DEVELOPMENT.

''(a) In General.--The Secretary shall, at the request of an
applicant, expedite the development and review of an application under
subsection (j) of section 505 for a drug--
''(1) for which there are not more than 3 approved drug
products listed under section 505(j)(7); or
''(2) that is included on the list under section 506E.
''(b) Request From Sponsors.--A request to expedite the development
and review of an application under subsection (a) shall be submitted by
the applicant prior to the submission of such application.
''(c) Other Applications.--Nothing in this section shall prevent
the Secretary from expediting the development and review of other
applications as the Secretary determines appropriate.
''(d) Additional Communication.--The Secretary shall take such
actions as are appropriate to expedite the development and review of
the application for approval of a drug described in subsection (a),
including, as appropriate--
''(1) holding meetings with the sponsor and the review team
throughout the development of the drug prior to submission of
the application;
''(2) providing timely advice to, and interactive
communication with, the sponsor regarding the development of
the application to ensure that the collection of nonclinical
and clinical data necessary for approval is as efficient as
practicable;
''(3) in the case of a complex product, assigning a cross-
disciplinary project lead for the review team to facilitate an
efficient review of the development program and application,
including manufacturing inspections; and
''(4) in the case of a complex product, including drug-
device combinations, involving senior managers and experienced
review staff, as appropriate, in a collaborative, cross-
disciplinary review.
''(e) Reporting Requirement.--A sponsor of a drug expedited under
this section shall report to the Secretary, one year following approval
of an application under section 505(j), on whether the approved drug
has been marketed in interstate commerce since approval.''.

SEC. 202. LIST OF GENERIC DRUGS WITH LIMITED COMPETITION.

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351 et seq.) is amended by inserting after section 506H, as added by
section 201, the following:

''SEC. 506I. DRUG LISTING.

''(a) Removal, Withdrawal, or Transfer.--The holder of an
application approved under subsection (b) or (j) of section 505 shall
notify the Secretary within 180 days of removing the drug that is the
subject of such application from interstate commerce, withdrawing such
approved application, or transferring such approved application, and a
reason for such removal, withdrawal, or transfer. If compliance with
this subsection within such 180-day period is not practicable, then the
holder shall comply as soon as practicable. The Secretary shall cross-
reference information listed pursuant to section 506C where applicable
to avoid duplicative reporting. Notification to the Secretary by a
manufacturer in accordance with section 506C(a) shall be deemed to be
compliance with this section.
''(b) Drugs With Limited Competition.--
''(1) Information.--The Secretary shall--
''(A) maintain information with respect to
applications approved under section 505(j); and
''(B) publish on the Internet website of the Food
and Drug Administration such information under
subparagraph (A) with respect to drugs for which there
are three or fewer application holders; and
''(C) update the information published pursuant to
subparagraph (B) every 180 days.
''(2) Contents.--The public information maintained and
published under paragraph (1)(B) shall include--
''(A) the name of the drug, name of the holder of
the approved application, and the marketing status for
each drug; and
''(B) an indication of whether the Secretary
considers the drug to be for the treatment or
prevention of a serious disease or medical condition,
for which there is no alternative drug that is judged
by medical professionals to be an adequate substitute
available in adequate supply.
''(c) Public Health Exception.--The Secretary may choose not to
make information collected under this section publicly available if the
Secretary determines that disclosure of such information would
adversely affect the public health.
''(d) Notification.--When the Secretary first publishes the
information under subsection (b), the Secretary shall notify relevant
Federal agencies, including the Centers for Medicare & Medicaid
Services and the Federal Trade Commission, that the information has
been published and will be updated regularly.''.

SEC. 203. SUITABILITY PETITIONS.

(a) In General.--It is the sense of the Senate that the Food and
Drug Administration shall meet the requirement under section
505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(5)(C)) and section 314.93(e) of title 21, Code of Federal
Regulations, of responding to suitability petitions within 90 days of
submission.
(b) Report.--The Secretary of Health and Human Services shall
include in the annual reports under section 102(b)--
(1) the number of pending petitions under section
505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(5)(C)); and
(2) the number of such petitions pending a substantive
response for more than 180 days from the date of receipt.

SEC. 204. INSPECTIONS.

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)), as amended by section 101, is further amended by adding
at the end the following:
''(14) If the Secretary issues feedback pursuant to section
704(b)(2) with respect to information submitted in response to a report
under section 704(b)(1), and a report that was issued under section
704(b)(1) is the only obstacle to approval of an application under this
subsection or the Secretary determines that the public health benefit
of approving an application under this subsection outweighs any risk to
public health, the Secretary shall, within 45 days of notification by
the applicant that necessary changes have been made to the
establishment to address any findings or deficiencies identified
previously by the Secretary--
''(A) re-inspect the establishment with respect to which
the report was issued; or
''(B) make a determination regarding the response to such
report and review of such application.''.
A:
Making Pharmaceutical Markets More Competitive Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) toprioritize the review of generic drug applications and supplementswith respect todrugs that are in a shortage or for which there are not more than three approved drugs. The holder of an approved drug application must notify the FDA within 180 days of withdrawing or transferring the application or withdrawing the drug from sale. The FDA must maintain a list of generic drugs with three or fewer holders of approved applications.