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. SHORT TITLE.

This Act may be cited as the ''National Park Centennial Act of
2004''.

SEC. 2. FINDINGS AND PURPOSE.

(a) Findings.--Congress finds:
(1) The National Park Service was established to conserve
the national parks, their scenery, natural and historic
objects, and wildlife for the enjoyment, in such manner and by
such means as will leave them unimpaired for the enjoyment of
future generations.
(2) The central purpose of the establishment of our
national parks is being challenged by chronic funding
shortfalls, which have created annual shortfalls in operational
funding that exceed $600,000,000, and have amassed a
maintenance backlog estimated by the General Accounting Office
at between $4,080,000,000 and $6,800,000,000.
(3) Without providing the Park Service the resources
necessary to operate and maintain our national parks, future
generations will receive diminished visitor services, will
experience a continually weakening system that is less and less
able to fulfill its mission, and will inherit a national park
system than has been left to them in worse condition that it
was left to their ancestors.
(4) The annual appropriations process has proved incapable
of fully addressing the debilitating funding shortfalls of the
national parks, making it necessary to supplement what the
appropriations process is able to accomplish.
(5) It is necessary to ensure that fiscal resources devoted
to the national parks are spent wisely and effectively, making
strong congressional oversight over annual appropriations
extremely important.
(6) Congress can enhance the resources available for
national park operations and ensure adequate oversight over
Park Service spending by removing from the appropriations
process a series of funding responsibilities that are outside
the core operating budgets for the national parks.
(b) Purpose.--The purpose of this Act is to eliminate the annual
operating deficit and the maintenance backlog in the national parks by
the centennial anniversary of the National Park System by enabling
Congress to focus on overseeing and fully funding the core operations
of the national parks in the annual appropriations process.

TITLE I--CENTENNIAL FUND

SEC. 101. CENTENNIAL FUND FOR PRESERVING AMERICA'S NATIONAL PARKS.

(a) Establishment.--There is established in the Treasury of the
United States a fund which shall be known as the ''National Park
Centennial Fund'', hereinafter in this Act referred to as the
''Centennial Fund''. In each fiscal year beginning in fiscal year 2005,
the Secretary of the Treasury shall deposit in the Centennial Fund
amounts set forth in subsection (b) sufficient to fund the programs
identified in titles II, III, and IV.
(b) Appropriations.--There are hereby appropriated to the
Centennial Fund in each fiscal year, the following amounts:
(1) Amounts equivalent to the amounts designated in the
fiscal year concerned under section 6097 of the Internal
Revenue Code of 1986.
(2) Any additional amounts necessary to make the total
amounts deposited to the Centennial Fund each fiscal year equal
to the total amount listed in section 103.

SEC. 102. DESIGNATION OF OVERPAYMENTS AND CONTRIBUTIONS FOR THE BENEFIT
OF UNITS OF THE NATIONAL PARK SYSTEM.

(a) In General.--Subchapter A of chapter 61 of the Internal Revenue
Code of 1986 is amended by adding at the end the following new part:

''PART IX--DESIGNATION OF OVERPAYMENTS AND CONTRIBUTIONS FOR THE
BENEFIT OF UNITS OF THE NATIONAL PARK SYSTEM

''Sec. 6097. Designation.

''SEC. 6097. DESIGNATION.

''(a) In General.--In the case of an individual, with respect to
each taxpayer's return for the taxable year of the tax imposed by
chapter 1, such taxpayer may designate that--
''(1) a specified portion (but not less than $1) of any
overpayment of tax for such taxable year, and
''(2) any cash contribution which the taxpayer includes
with such return, shall be used for the benefit of units of the
National Park System.
''(b) Manner and Time of Designation.--A designation under
subsection (a) may be made with respect to any taxable year only at the
time of filing the return of the tax imposed by chapter 1 for such
taxable year. Such designation shall be made in such manner as the
Secretary prescribes by regulations except that such designation shall
be made either on the first page of the return or on the page bearing
the taxpayer's signature.
''(c) Overpayments Treated as Refunded.--For purposes of this
title, any portion of any overpayment of tax designated under
subsection (a) shall be treated as being refunded to the taxpayer as of
the last date prescribed for filing the return of tax imposed by
chapter 1 (determined without regard to extensions) or, if later, the
date the return is filed.''.
(b) Clerical Amendment.--The table of parts for subchapter A of
chapter 61 of such Code is amended by adding at the end thereof the
following new item:

''Part IX. Designation of overpayments and contributions for the
benefit of units of the National Park System''.

(c) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after December 31, 2004.

SEC. 103. PROGRAM ALLOCATION.

The following amounts shall be deposited in the Centennial Fund
from amounts designated under section 102 (and from the General Fund of
the Treasury to the extent the amounts so designated are less than the
total amounts specified in this section for the fiscal year concerned).
Such amounts shall, without further appropriation, be available to the
Secretary of the Interior until expended:
(1) Fiscal year 2005: $100,000,000.
(2) Fiscal year 2006: $125,000,000.
(3) Fiscal year 2007: $150,000,000.
(4) Fiscal year 2008: $175,000,000.
(5) Such sums as may be necessary through fiscal year 2016.

SEC. 104. DISTRIBUTION OF FUND.

There are hereby created within the Centennial Fund 3 accounts,
designated for the following purposes:
(1) National Park Backlog Elimination Fund (60 percent).
(2) Natural Resource Challenge Fund (20 percent).
(3) Cultural Resource Challenge Fund (20 percent).

SEC. 105. PATRIOTS FOR PARKS PROMOTION.

There are hereby authorized to be appropriated to the Secretary of
the Interior such sums as necessary for a public awareness campaign
about the existence of the National Park Centennial Fund created in
section 101 and the ability of taxpayers to contribute to it through
the tax checkoff created in section 6097 of the Internal Revenue Code
of 1986.

TITLE II--ELIMINATING THE NATIONAL PARK MAINTENANCE BACKLOG

SEC. 201. BACKLOG ELIMINATION.

(a) In General.--Sixty percent of the funds deposited into the
Centennial Fund shall be used to eliminate the backlog of unmet needs
in the National Parks, as identified in the Facility Condition Index
(hereinafter in this Act referred to as the ''FCI'') of the National
Park Service.
(b) Priorities.--(1) The Secretary of the Interior shall prepare,
as part of the annual budget proposal, a priority list for projects to
be funded under this section. Moneys shall be made available from the
fund, without further appropriation, effective October 15 of each
calendar year, for the projects identified on the priority list, unless
prior to such date, legislation is enacted establishing a different
priority list.
(2) In preparing the list of projects to be funded under this
section, the Secretary of the Interior shall give priority to projects
that--
(A) are identified in the park unit's general management
plan;
(B) are listed in the FCI;
(C) are identified by the Secretary of the Interior as
necessary to prevent immediate damage to the park unit's
natural, cultural, or historic resources, with priority given
to projects with the most significant benefit to conservation
of resources or visitor education; and
(D) are identified as necessary to promote public health
and safety.
(c) Overhead.--National Parks undertaking projects under this
section may allocate up to 8 percent of the funds for such projects for
oversight of such projects and other associated overhead
responsibilities.

TITLE III--PROTECTING NATURAL WONDERS

SEC. 301. NATURAL RESOURCE CHALLENGE.

(a) Natural Resource Protection.--Twenty percent of the funds
deposited into the Centennial Fund shall be used to protect natural
resources within the parks.
(b) Project Description.--The Secretary of the Interior shall
prepare, as part of the annual budget proposal, a description of
projects to be funded under this section. Moneys shall be made
available from the Centennial Fund, without further appropriation,
effective October 15 of each calendar year for activities that include
each of the following:
(1) Natural resource inventories.
(2) Monitoring efforts including air and water quality
monitoring.
(3) Protection of native and endangered species and their
habitats.
(4) Control of nonnative species.
(5) Resource planning.
(6) Increase collaboration with scientists.
(7) Authorized environmental restoration projects.
(8) Use of parks for learning.
(9) Establishment of partnerships with nonpark entities for
the purpose of leveraging Federal funds allocated to natural
resource protection.

TITLE IV--PROTECTING NATIONAL TREASURES

SEC. 401. CULTURAL RESOURCE CHALLENGE.

(a) Cultural Resources.--Twenty percent of the funds deposited into
the Centennial Fund shall be used to protect cultural resources within
the national parks.
(b) Project Description.--The Secretary of the Interior shall
prepare, as part of the annual budget proposal, a description of
projects to be funded under this section. Moneys shall be made
available from the fund, without further appropriation, effective
October 15 of each calendar year for activities that include each of
the following:
(1) Cultural or historic resources not listed on the FCI.
(2) Documenting and preserving archaeological sites.
(3) Preserving collections and archives.
(4) Ethnographic activities.
(5) Evaluating and protecting cultural landscapes.
(6) Establishment of partnerships with non-park entities
for the purpose of leveraging Federal funds allocated to
cultural resource protection.

TITLE V--MEETING ANNUAL OPERATING NEEDS

SEC. 501. PROGRESS ON ANNUAL APPROPRIATIONS.

(a) GAO Report.--The General Accounting Office annually shall
submit to the Committee on Appropriations, Committee on Government
Reform, and Committee on Resources of the United States House of
Representatives and to the Committee on Appropriations, Committee on
Government Affairs, and Committee on Energy and Natural Resources of
the United States Senate a report that describes each of the following:
(1) The progress of Congress in eliminating the annual
operating fund deficit in the National Park System, defined as
in excess of $600,000,000 based on a fiscal year 2002 estimate
of then-complete national park business plans, and projection
of when such deficit will be eliminated, based on funding
levels and trends.
(2) A comparison of business plan estimates of national
park needs versus actual funds appropriated to such parks.
(3) Any differences in the Park Service's business plan
methodology for the estimate in paragraph (2) of this
subsection compared to that used in fiscal year 2003.
(4) Management improvement measures undertaken by
individual park units and by the National Park Service as a
whole, including actual realized savings and actual impact on
visitor services and resource protection.
(5) Adjustments in, and the total number of, full-time
equivalent and actual positions dedicated to resource
protection, visitor services, interpretation, and other
employment categories.
(6) Any adjustments made in service to the public,
including but not limited to adjustments to visitor center
hours and the number or quality of ranger-led tours.
(7) Any changes in the Park Service's level of effort due
to partnership or other leveraged activities.
(8) Any new requirements and assessments placed on the
parks for unbudgeted expenses, including, but not limited to,
homeland security, natural disasters, and employee cost-of-
living adjustments.
(9) An assessment of the accuracy and completeness of the
Facility Condition Index described in Title I of this Act,
including adjustments made to such Index on an annual basis.
(b) Business Plan Implementation Pilot (Demonstration) Program.--In
consultation with the Director of the National Park Service, at least
60 percent of the amounts provided under Titles II, III, and IV shall
be distributed to national parks that have completed comprehensive
business plans under the Business Plan Initiative of the National Park
Service.
(c) Education and the National Parks.--The Secretary of Education
is hereby authorized to provide grants to elementary and secondary
schools to enter into cooperative agreements with the National Park
Service for the purpose of distance learning and onsite education
programs for the following purposes:
(1) Connecting students to the history of our Nation
through the national parks.
(2) Using the parks to facilitate scientific instruction.
(d) Intent of Congress to Supplement Annual Appropriations for
National Park Service.--Amounts made available by this Act are intended
by the Congress to supplement, and not detract from, annual
appropriations for the National Park Service.
Example Output: National Park Centennial Act of 2004 - Establishes the National Park Centennial Fund (Fund) in the Treasury.

Amends the Internal Revenue Code to allow individual taxpayers to designate overpayments and contributions for the benefit of the National Park System. Allocates such amounts to the Fund (along with necessary amounts from the General Fund to the extent that such amounts are inadequate in any fiscal year) for expenditure by the Secretary of the Interior.

Creates within the Fund the National Park Backlog Elimination Fund, the Natural Resource Challenge Fund, and the Cultural Resource Challenge Fund.

Authorizes appropriations for a public awareness campaign about the Fund and the ability of taxpayers to make tax-related contributions.

Requires a specified percentage of Fund deposits to be used: (1) for the elimination of the backlog of unmet needs in the national parks as identified in the Facility Condition Index of the National Park Service (NPS); (2) to protect natural resources within the parks; and (3) to protect cultural resources within the parks. Requires a majority of such percentages to be distributed to those national parks that have completed comprehensive business plans under the Business Plan Initiative of the NPS.

Directs the Government Accountability Office annually to submit a report on the National Park System to specified congressional committees.

Authorizes the Secretary of Education to provide grants to elementary and secondary schools for cooperative agreements with the NPS providing distance learning and onsite education programs.

Example Input: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Fuel Efficiency Energy Act of
2007''.

SEC. 2. DEFINITIONS.

(a) Automobile.--Section 32901(a)(3) of title 49, United States
Code, is amended--
(1) by striking ''4-wheeled''; and
(2) by striking '', and rated at--'' and all that follows
and inserting a period.
(b) Medium-Duty Truck.--Section 32901(a) of such title is amended--
(1) by redesignating paragraphs (14), (15), and (16) as
paragraphs (15), (16), and (17), respectively; and
(2) by inserting after paragraph (13) the following:
''(14) 'medium-duty truck' means a truck (as defined in
section 30127) with a gross vehicle weight between 10,000 and
26,000 pounds.''.
(c) Passenger Automobile.--Section 32901(a)(17) of such title, as
redesignated by subsection (b)(1), is amended by striking ''decides by
regulation--'' and all that follows through the period and inserting
''determines by regulation, to have a significant feature (except 4-
wheel drive) designed for off-highway operation.''.
(d) Fuel Economy Information.--Section 32908(a) of such title is
amended--
(1) in the subsection heading, by striking ''Definitions''
and inserting ''Definition''; and
(2) by striking ''section--'' and all that follows through
''(2)'' and inserting ''section, the term''.

SEC. 3. ANNUAL INCREASE IN AVERAGE FUEL ECONOMY STANDARDS.

(a) Fuel Efficiency Standards.--
(1) In general.--Section 32902 of title 49, United States
Code, is amended by striking subsections (a) through (c) and
inserting the following:
''(a) In General.--Not later than 18 months before the beginning of
each model year beginning with model year 2012, the Secretary of
Transportation, shall prescribe, by regulation, average fuel economy
standards for automobiles manufactured by a manufacturer for that model
year in accordance with subsection (b). The Secretary of Transportation
shall prescribe separate average fuel economy standards for different
classes of automobiles. The Secretary shall establish average fuel
economy standards for medium-duty trucks that are consistent with the
projected benefits of hybridization.
''(b) Annual Increases in Fuel Economy Standards.--
''(1) For model year 2012.--For model year 2012, the
average fuel economy standard for each class of automobiles
shall be the average combined highway and city miles per gallon
performance of all automobiles within that class of automobiles
in 2011 (rounded to the nearest /10\ mile per gallon).
''(2) For model years after model year 2012.--For each
model year beginning with model year 2013 and ending with model
year 2030, the average fuel economy attained by the fleet of
automobiles manufactured or sold in the United States shall be
at least 4 percent greater than the average fuel economy
standard for the fleet in the previous model year (rounded to
the nearest /10\ mile per gallon).
''(c) Amending Fuel Economy Standards.--
''(1) In general.--Notwithstanding subsections (a) and (b),
the Secretary of Transportation may prescribe an average fuel
economy standard for a class of automobiles in a model year
that is lower than the standard required under subsection (b)
if the Secretary of Transportation, in consultation with the
National Academy of Sciences, determines that the average fuel
economy standard prescribed in accordance with subsections (a)
and (b) for that class of automobiles in that model year--
''(A) is not technologically achievable;
''(B) cannot be achieved without materially
reducing the overall safety of automobiles manufactured
or sold in the United States and no offsetting safety
improvements can be practicably implemented for that
model year; or
''(C) is shown not to be cost effective.
''(2) Maximum standard.--Any average fuel economy standard
prescribed for a class of automobiles in a model year under
paragraph (1) shall be the maximum standard that--
''(A) is technologically achievable;
''(B) can be achieved without materially reducing
the overall safety of automobiles manufactured or sold
in the United States; and
''(C) is cost effective.
''(3) Considerations in determination of cost
effectiveness.--In determining cost effectiveness under
paragraph (1)(C), the Secretary of Transportation shall take
into account the total value to the United States of reduced
petroleum use, including the value of reducing external costs
of petroleum use, using a value for such costs equal to 50
percent of the value of 1 gallon of gasoline saved or the
amount determined in an analysis of the external costs of
petroleum use that considers--
''(A) value to consumers;
''(B) economic security;
''(C) national security;
''(D) foreign policy;
''(E) the impact of oil use--
''(i) on sustained cartel rents paid to
foreign suppliers;
''(ii) on long-run potential gross domestic
product due to higher normal-market oil price
levels, including inflationary impacts;
''(iii) on import costs, wealth transfers,
and potential gross domestic product due to
increased trade imbalances;
''(iv) on import costs and wealth transfers
during oil shocks;
''(v) on macroeconomic dislocation and
adjustment costs during oil shocks;
''(vi) on the cost of existing energy
security policies, including the management of
the Strategic Petroleum Reserve;
''(vii) on the timing and severity of the
oil peaking problem;
''(viii) on the risk, probability, size,
and duration of oil supply disruptions;
''(ix) on the strategic behavior of the
Organization of the Petroleum Exporting
Countries and long-run oil pricing;
''(x) on the short term elasticity of
energy demand and the magnitude of price
increases resulting from a supply shock;
''(xi) on oil imports, military costs, and
related security costs, including intelligence,
homeland security, sea lane security and
infrastructure, and other military activities;
''(xii) on oil imports, diplomatic and
foreign policy flexibility, and connections to
geopolitical strife, terrorism, and
international development activities;
''(xiii) all relevant environmental hazards
under the jurisdiction of the Environmental
Protection Agency; and
''(xiv) on well-to-wheels urban and local
air emissions of pollutants and their
uninternalized costs;
''(F) the impact of the oil or energy intensity of
the United States economy on the sensitivity of the
economy to oil price changes, including the magnitude
of gross domestic product losses in response to short
term price shocks or long term price increases;
''(G) the impact of United States payments for oil
imports on political, economic, and military
developments in unstable or unfriendly oil-exporting
countries;
''(H) the uninternalized costs of pipeline and
storage oil seepage, and for risk of oil spills from
production, handling, and transport, and related
landscape damage; and
''(I) additional relevant factors, as determined by
the Secretary.
''(4) Minimum valuation.--When considering the value to
consumers of a gallon of gasoline saved, the Secretary of
Transportation may not use a value less than the greatest of--
''(A) the average national cost of a gallon of
gasoline sold in the United States during the 12-month
period ending on the date on which the new fuel economy
standard is proposed;
''(B) the most recent weekly estimate by the Energy
Information Administration of the Department of Energy
of the average national cost of a gallon of gasoline
(all grades) sold in the United States; and
''(C) the gasoline prices projected by the Energy
Information Administration for the 20-year period
beginning in the year following the year in which the
standards are established.''.
(2) Conforming amendments.--Title 49, United States Code,
is amended--
(A) in section 32902--
(i) in subsection (d) by striking
''subsection (b) or (c) of this section'' and
inserting ''subsection (a), (b), or (c)'';
(ii) by striking subsection (f);
(iii) in subsection (g)--
(I) by striking ''subsection (a) or
(d)'' and inserting ''this section'';
and
(II) by striking ''(and submit the
amendment to Congress when required
under subsection (c)(2) of this
section)''; and
(iv) in subsection (h) by striking
''subsections (c), (f), and (g) of this
section'' and inserting ''subsections (c) and
(g)'';
(B) in section 32903--
(i) by striking ''section 32902(b)-(d) of
this title'' each place it occurs and inserting
''subsections (a) through (d) of section
32902''; and
(ii) in subsection (e), by striking
''section 32902(a) of this title'' and
inserting ''subsections (a) through (d) of
section 32902''; and
(C) in section 32904--
(i) in subsection (a)--
(I) by striking ''subject to--''
and all that follows through ''(B)
section 32902(a)-(d) of this title''
and inserting ''subject to subsections
(a) through (d) of section 32902''; and
(II) by redesignating clauses (i)
and (ii) as subparagraphs (A) and (B),
respectively.
(b) Repeal of Credit for Dual Fueled Automobiles.--
(1) In general.--Section 32905 of title 49, United States
Code, is amended--
(A) by amending subsection (b) to read as follows:
''(b) Dual Fueled Automobiles.--The Administrator of the
Environmental Protection Agency shall measure the fuel economy for any
model of dual fueled automobile manufactured in model year 2012 and any
model year thereafter, in accordance with section 32904.''; and
(B) by amending subsection (d) to read as follows:
''(d) Gaseous Fuel Dual Fueled Automobiles.--The Administrator of
the Environmental Protection Agency shall measure the fuel economy for
any model of gaseous fuel dual fueled automobile manufactured in model
year 2012 and any model year thereafter, in accordance with section
32904.''.
(2) Conforming amendments.--Section 32905 of such title is
further amended--
(A) by striking subsection (f); and
(B) redesignating subsections (g) and (h) as
subsections (f) and (g), respectively.

SEC. 4. REQUIREMENT TO INCREASE PERCENTAGE OF DUAL FUELED AUTOMOBILES.

Section 32902 of title 49, United States Code, as amended by
section 3, is further amended by inserting after subsection (e) the
following:
''(f) Requirement for Annual Increase in Duel Fueled Automobiles.--
Each manufacturer shall ensure that the percentage of automobiles
manufactured by such manufacturer in each of model years 2012 through
2022 that are dual fueled automobiles is not less than 10 percent
greater than the percentage of automobiles manufactured by such
manufacturer in the previous model year that are dual fueled
automobiles.''.

SEC. 5. EFFECTIVE DATE.

The amendments made by this Act shall--
(1) take effect on January 1, 2010; and
(2) apply to automobiles manufactured for model year 2012
and for each subsequent model year.
Example Output: Fuel Efficiency Energy Act of 2007 - Amends corporate average fuel economy (CAFE) provisions to revise the definition of: (1) "automobile" to mean any vehicle that is propelled by fuel, or by alternative fuel, and is manufactured primarily for use on public streets, roads, and highways (currently, four-wheeled vehicles that are so propelled and manufactured for such use and that are up to 6,000 pounds and certain vehicles between 6,000 and 10,000 pounds); and (2) "passenger automobile" to eliminate the exception for 4-wheel drive automobiles and vehicles weighing more than 6,000 pounds. Defines "medium-duty truck" as a truck with a gross vehicle weight between 10,000 and 26,000 pounds.

Requires the Secretary of Transportation to: (1) prescribe separate increased minimum CAFE standards for different classes of automobiles manufactured beginning for model year 2012, but adds an increase of 4% per year in such standard for model years 2013 through 2030; and (2) establish CAFE standards for medium-duty trucks that are consistent with hybridization beginning for model year 2012.

Revises the calculation of fuel economy standards for dual fueled automobiles and gaseous fuel dual fueled automobiles manufactured in model year 2012 and beyond to require using the same calculation provisions as used for gas or diesel fueled vehicles. Repeals provisions allowing the Department of Transportation (DOT) to extend manufacturing credits for such automobiles.

Example Input: 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.''.
Example Output:
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.