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Q: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Senator Paul Simon Water for the
World Act of 2009''.

SEC. 2. FINDINGS.

Congress finds the following:
(1) The Senator Paul Simon Water for the Poor Act of 2005
(Public Law 109-121)--
(A) makes access to safe water and sanitation for
developing countries a specific policy objective of
United States foreign assistance programs;
(B) requires the Secretary of State to--
(i) develop a strategy to elevate the role
of water and sanitation policy; and
(ii) improve the effectiveness of United
States assistance programs undertaken in
support of that strategy;
(C) codifies Target 10 of the United Nations
Millennium Development Goals; and
(D) seeks to reduce by half between 1990 (the
baseline year) and 2015--
(i) the proportion of people who are unable
to reach or afford safe drinking water; and
(ii) the proportion of people without
access to basic sanitation.
(2) On December 20, 2006, the United Nations General
Assembly, in GA Resolution 61/192, declared 2008 as the
International Year of Sanitation, in recognition of the impact
of sanitation on public health, poverty reduction, economic and
social development, and the environment.
(3) On August 1, 2008, Congress passed H. Con. Res. 318,
which--
(A) supports the goals and ideals of the
International Year of Sanitation; and
(B) recognizes the importance of sanitation on
public health, poverty reduction, economic and social
development, and the environment.
(4) While progress is being made on safe water and
sanitation efforts--
(A) more than 884,000,000 people throughout the
world lack access to safe drinking water; and
(B) 2 of every 5 people in the world do not have
access to basic sanitation services.
(5) The health consequences of unsafe drinking water and
poor sanitation are significant, accounting for--
(A) nearly 10 percent of the global burden of
disease; and
(B) more than 2,000,000 deaths each year.
(6) The effects of climate change are expected to produce
severe consequences for water availability and resource
management in the future, with 2,800,000,000 people in more
than 48 countries expected to face severe and chronic water
shortages by 2025.
(7) According to the November 2008 report entitled,
''Global Trends 2025: A Transformed World'', the National
Intelligence Council expects rapid urbanization and future
population growth to exacerbate already limited access to
water, particularly in agriculture-based economies.
(8) A 2009 report published in the Proceedings of the
National Academy of Sciences projects that the effects of
climate change will produce long-term droughts and raise sea
levels for the next 1,000 years, regardless of future efforts
to combat climate change.
(9) According to the 2005 Millennium Ecosystem Assessment,
commissioned by the United Nations, more than /5\ of the
world population relies on freshwater that is either polluted
or excessively withdrawn.
(10) The impact of water scarcity on conflict and
instability is evident in many parts of the world, including
the Darfur region of Sudan, where demand for water resources
has contributed to armed conflict between nomadic ethnic groups
and local farming communities.
(11) In order to further the United States contribution to
safe water and sanitation efforts, it is necessary to--
(A) expand foreign assistance capacity to address
the challenges described in this section; and
(B) represent issues related to water and
sanitation at the highest levels of United States
foreign assistance and diplomatic deliberations,
including those related to issues of global health,
food security, the environment, global warming, and
maternal and child mortality.

SEC. 3. SENSE OF CONGRESS.

It is the sense of Congress that the United States should lead a
global effort to bring sustainable access to clean water and sanitation
to poor people throughout the world.

SEC. 4. PURPOSE.

The purpose of this Act is--
(1) to provide first-time access to safe water and
sanitation, on a sustainable basis, for 100,000,000 people in
high priority countries (as designated under section 6(f) of
the Senator Paul Simon Water for the Poor Act of 2005 (22
U.S.C. 2152h note)) by 2015; and
(2) to enhance the capacity of the United States Government
to fully implement the Senator Paul Simon Water for the Poor
Act of 2005 (Public Law 109-121).

SEC. 5. DEVELOPING UNITED STATES GOVERNMENT CAPACITY.

Section 135 of the Foreign Assistance Act of 1961 (22 U.S.C. 2152h)
is amended by adding at the end the following:
''(e) Office of Water.--
''(1) Establishment.--To carry out the purposes of
subsection (a), the Administrator of the United States Agency
for International Development shall establish the Office of
Water within the Bureau for Economic Growth, Agriculture, and
Trade.
''(2) Leadership.--The Office of Water shall be headed by a
Director for Safe Water and Sanitation, who shall report
directly to the Assistant Administrator of the Bureau for
Economic Growth, Agriculture, and Trade.
''(3) Duties.--The Director shall--
''(A) implement this section and the Senator Paul
Simon Water for the Poor Act of 2005 (Public Law 109-
121);
''(B) develop and implement country-specific water
strategies and expertise, in collaboration with
appropriate United States Agency for International
Development Mission Directors, to meet the goal of
providing 100,000,000 additional people with
sustainable access to safe water and sanitation by
2015; and
''(C) place primary emphasis on providing safe,
affordable, and sustainable drinking water, sanitation,
and hygiene in a manner that--
''(i) is consistent with sound water
resource management principles; and
''(ii) utilizes such approaches as direct
service provision, capacity building,
institutional strengthening, regulatory reform,
and partnership collaboration.
''(4) Capacity.--The Director may utilize interagency
details or partnerships with universities, civil society, and
the private sector, as needed, to strengthen implementation
capacity.
''(f) Special Coordinator for International Water.--
''(1) Establishment.--To increase the capacity of the
Department of State to address international issues regarding
safe water, sanitation, integrated river basin management, and
other international water programs, the Secretary of State
shall establish a Special Coordinator for International Water
(referred to in this subsection as the 'Special Coordinator'),
who shall report to the Under Secretary for Democracy and
Global Affairs.
''(2) Duties.--The Special Coordinator shall--
''(A) oversee and coordinate the diplomatic policy
of the United States Government with respect to global
freshwater issues, including interagency coordination
related to--
''(i) sustainable access to safe drinking
water, sanitation, and hygiene;
''(ii) integrated river basin and watershed
management;
''(iii) transboundary conflict;
''(iv) agricultural and urban productivity
of water resources;
''(v) disaster recovery, response, and
rebuilding;
''(vi) pollution mitigation; and
''(vii) adaptation to hydrologic change due
to climate variability; and
''(B) ensure that international freshwater issues
are represented--
''(i) within the United States Government;
and
''(ii) in key diplomatic, development, and
scientific efforts with other nations and
multilateral organizations.
''(3) Staff.--The Special Coordinator is authorized to hire
a limited number of staff to carry out the duties described in
paragraph (2).''.

SEC. 6. SAFE WATER, SANITATION, AND HYGIENE STRATEGY.

Section 6 of the Senator Paul Simon Water for the Poor Act of 2005
(22 U.S.C. 2152h note) is amended--
(1) in subsection (c), by adding at the end the following:
''In developing the program activities needed to implement the
strategy, the Secretary shall consider the results of the
assessment described in subsection (e)(9).''; and
(2) in subsection (e)--
(A) in paragraph (5), by striking ''and'' at the
end;
(B) in paragraph (6), by striking the period at the
end and inserting a semicolon; and
(C) by adding at the end the following:
''(7) an assessment of all United States Government foreign
assistance allocated to the drinking water and sanitation
sector during the 3 previous fiscal years, across all United
States Government agencies and programs, including an
assessment of the extent to which the United States
Government's efforts are reaching the goal of providing first-
time access to safe water and sanitation on a sustainable basis
for 100,000,000 people in high priority countries;
''(8) recommendations on what the United States Government
would need to do to achieve the goals referred to in paragraph
(7), in support of the United Nation's Millennium Development
Goal on access to safe drinking water; and
''(9) an assessment of best practices for mobilizing and
leveraging the financial and technical capacity of business,
governments, nongovernmental organizations, and civil society
in forming public-private partnerships that measurably increase
access to safe drinking water and sanitation.''.

SEC. 7. DEVELOPING LOCAL CAPACITY.

The Senator Paul Simon Water for the Poor Act of 2005 (Public Law
109-121) is amended--
(1) by redesignating sections 9, 10, and 11 as sections 10,
11, and 12, respectively; and
(2) by inserting after section 8 the following:

''SEC. 9. WATER AND SANITATION INSTITUTIONAL CAPACITY-BUILDING PROGRAM.

''(a) Establishment.--
''(1) In general.--The Secretary of State and the
Administrator of the United States Agency for International
Development (referred to in this section as the 'Secretary' and
the 'Administrator', respectively), in consultation with host
country institutions, the Centers for Disease Control and
Prevention, the Department of Agriculture, and other agencies,
as appropriate, shall establish, in every high priority
country, a program to build the capacity of host country
institutions and officials responsible for water and sanitation
in countries that receive assistance under section 135 of the
Foreign Assistance Act of 1961, including training at
appropriate levels, to--
''(A) provide affordable, equitable, and
sustainable access to safe drinking water and
sanitation;
''(B) educate the populations of such countries
about the dangers of unsafe drinking water and lack of
proper sanitation; and
''(C) encourage behavior change to reduce
individuals' risk of disease from unsafe drinking water
and lack of proper sanitation and hygiene.
''(2) Coordination.--The programs established under
subsection (a) shall be coordinated in each country by the lead
country water manager designated in subsection (b)(2).
''(3) Expansion.--The Secretary and the Administrator may
establish the program described in this section in additional
countries if the receipt of such capacity building would be
beneficial for promoting access to safe drinking water and
sanitation, with due consideration given to good governance.
''(4) Capacity.--The Secretary and the Administrator--
''(A) shall designate staff with appropriate
expertise to carry out the strategy developed under
section 4; and
''(B) may utilize, as needed, interagency details
or partnerships with universities, civil society, and
the private sector to strengthen implementation
capacity.
''(b) Designation.--The United States Agency for International
Development Mission Director for each country receiving a 'high
priority' designation under section 6(f) and for each region containing
a country receiving such designation shall--
''(1) designate safe drinking water and sanitation as a
strategic objective;
''(2) appoint an employee of the United States Agency for
International Development as in-country water and sanitation
manager to coordinate the in-country implementation of this Act
and section 135 of the Foreign Assistance Act of 1961 (22
U.S.C. 2152h) with host country officials at various levels of
government responsible for water and sanitation, the Department
of State, and other relevant United States Government agencies;
and
''(3) coordinate with the Development Credit Authority and
the Global Development Alliance to further the purposes of this
Act.''.

SEC. 8. OTHER ACTIVITIES SUPPORTED.

Section 135(c) of the Foreign Assistance Act (22 U.S.C. 2152h(c))
is amended--
(1) in paragraph (3), by striking ''and'' at the end;
(2) in paragraph (4), by striking the period at the end;
and
(3) by adding at the end the following:
''(5) foster global cooperation on research and technology
development, including regional partnerships among water
experts to address safe drinking water, sanitation, water
resource management, and other water-related issues;
''(6) establish regional and cross-border cooperative
activities between scientists and specialists that work to
share technologies and best practices, mitigate shared water
challenges, foster international cooperation, and defuse cross-
border tensions;
''(7) provide grants through the United States Agency for
International Development to foster the development,
dissemination, and increased and consistent use of low cost and
sustainable technologies, such as household water treatment,
hand washing stations, and latrines, for providing safe
drinking water, sanitation, and hygiene that are suitable for
use in high priority countries, particularly in places with
limited resources and infrastructure;
''(8) in collaboration with the Centers for Disease Control
and Prevention, Department of Agriculture, the Environmental
Protection Agency, the National Oceanic and Atmospheric
Administration, and other agencies, as appropriate, conduct
formative and operational research and monitor and evaluate the
effectiveness of programs that provide safe drinking water and
sanitation; and
''(9) integrate efforts to promote safe drinking water,
sanitation and hygiene with existing foreign assistance
programs, as appropriate, including activities focused on HIV/
AIDS, malaria, tuberculosis, maternal and child health, food
security, and nutritional support.''.

SEC. 9. UPDATED REPORT REGARDING WATER FOR PEACE AND SECURITY.

Section 11(b) of the Senator Paul Simon Water for the Poor Act of
2005, as redesignated by section 7, is amended by adding at the end the
following: ''The report submitted under this subsection shall include
an assessment of current and likely future political tensions over
water sources and multidisciplinary assessment of the expected impacts
of global climate change on water supplies in 10, 25, and 50 years.''.

SEC. 10. AUTHORIZATION OF APPROPRIATIONS.

(a) In General.--There are authorized to be appropriated for fiscal
year 2009 and for each subsequent fiscal year such sums as may be
necessary to carry out this Act and the amendments made by this Act,
pursuant to the criteria set forth in the Senator Paul Simon Water for
the Poor Act of 2005 (Public Law 109-121).
(b) Use of Funds.--
(1) General water resource management activities.--Up to 20
percent of the amounts appropriated to implement this Act may
be used to support general water resource management activities
that improve countries' overall water sources.
(2) Other activities.--Any amounts appropriated to
implement this Act that are not used to carry out the
activities described in paragraph (1) shall be allocated for
activities related to safe drinking water, sanitation, and
hygiene.

A: Senator Paul Simon Water for the World Act of 2009 - Amends the Foreign Assistance Act of 1961 to direct the Administrator of the United States Agency for International Development (USAID) to establish the Office of Water within the Bureau for Economic Growth, Agriculture, and Trade to: (1) give assistance to provide safe water and sanitation for people worldwide; and (2) be headed by a Director for Safe Water and Sanitation. Outlines the Director's duties.

Requires the Secretary of State, in order to increase the capacity of the Department of State to address international issues regarding safe water, sanitation, integrated river basin management, and other international water programs, to establish a Special Coordinator for International Water. Outlines the Special Coordinator's duties.

Amends the Senator Paul Simon Water for the Poor Act of 2005 to: (1) revise requirements concerning the safe water and sanitation strategy; (2) provide for the establishment of a program to build the capacity of host country institutions and officials responsible for water and sanitation in countries that receive assistance to provide safe water and sanitation under the Foreign Assistance Act of 1961; (3) expand the list of activities that may be supported by assistance furnished by the President for programs in developing countries to provide affordable and equitable access to safe water and sanitation; and (4) require the report regarding water for peace and security to include an assessment of political tensions over water sources and a multidisciplinary assessment of the expected impacts of global climate change on water supplies in 10, 25, and 50 years.
****
Q: SECTION 1. SHORT TITLE.

This Act may be cited as the ''National Coast Guard Museum Act of
2001''.

SEC. 2. FINDINGS.

The Congress finds the following:
(1) There is no national museum to commemorate and honor
the Coast Guard's history, mission, personnel, and traditions
or those of its predecessor services and agencies.
(2) There should be established a National Coast Guard
Museum to commemorate the 210 years of national maritime and
military history of the Coast Guard and its predecessor
services and agencies.

SEC. 3. DEFINITIONS.

In this Act:
(1) Association.--The term ''Association'' means the
National Coast Guard Museum Association (a nonprofit
corporation established under the laws of the State of
Massachusetts), or a similar organization.
(2) Museum.--The term ''Museum'' means the National Coast
Guard Museum established under sections 4(a).
(3) Commandant.--The term ''Commandant'' means the
Commandant of the Coast Guard.
(4) Fund.--The term ''Fund'' means the National Coast Guard
Museum Fund established under section 5(a).

SEC. 4. NATIONAL COAST GUARD MUSEUM.

(a) Establishment.--The Commandant may, in accordance with this
section, establish, operate, and maintain a National Coast Guard Museum
on Federal lands that are administered by the Coast Guard and specified
by the Commandant.
(b) Construction.--
(1) License.--The Commandant may grant a license to the
Association authorizing the Association to construct facilities
for the Museum on the land specified under subsection (a).
(2) Terms.--The license under this subsection shall include
terms that establish the following:
(A) Upon completion of construction of facilities
under the license, the Association shall donate such
facilities, including any associated improvements,
fixtures, and related personal property, as a gift to
Coast Guard.
(B) The United States shall have no responsibility
for project management.
(C) The Association shall be responsible for
preparation of the design and plans for facilities
constructed under the license, except that the design
and plans shall be subject to the approval of the
Commandant
(3) Funding.--(A) The Commandant shall not allow
construction of facilities for the Museum to begin, and may not
provide any Federal funds for that construction, unless the
Commandant determines that sufficient amounts, not less than
$10,000,000, are available from non-Federal sources to complete
construction of the Museum in accordance with the design and
plans approved under paragraph (2)(C).
(B) For the purposes of constructing the Museum, and
subject to the availability of appropriations, the Commandant
may transfer to the Association up to $10,000,000.
(C) The Commandant shall require that amounts transferred
under subparagraph (B) that are not expended on the
construction of the Museum shall be returned to the Coast Guard
and deposited into the Fund.
(4) Liability.--The United States shall not be liable for
any act or omission relating to construction under the license.
(c) Commandant's Authorities.--Notwithstanding any other provision
of law, in connection with the establishment, operation, and
maintenance of the Museum, the Commandant may--
(1) rent or lease space within the Museum for gift shops,
food concessions, meeting or special event spaces, and similar
purposes or activities, under such terms and conditions, and
for such periods of time, as the Commandant considers
appropriate;
(2) accept, hold, administer, and, without further Act of
appropriation, spend any gift, devise, or bequest of real or
personal property (including funds) that is made on the
condition that it be used for the benefit of, or in connection
with the establishment, operation, or maintenance of, the
Museum;
(3) pay necessary expenses in connection with the
conveyance or transfer of any such gift, devise or bequest; and
(4) perform other acts as the Commandant deems reasonable
and appropriate.
(d) Treatment of Gifts.--For the purposes of Federal income,
estate, and gift taxes, property that is accepted under subsection
(c)(2) shall be considered as a gift, devise, or bequest to or for the
use of the United States.

SEC. 5. NATIONAL COAST GUARD MUSEUM FUND.

(a) Establishment.--There is established in the Treasury a separate
account that shall be known as the ''National Coast Guard Museum
Fund''.
(b) Contents.--The Fund shall consist of the following:
(1) Gifts, devises, and bequests of funds accepted under
section 4(c)(2).
(2) Amounts received by the United States from the rental
or leasing of space within the Museum under section 4(a).
(3) Interest credited under subsection (d).
(4) Amounts deposited under section 4(b)(3)(C).
(c) Use.--The Commandant may make disbursements from the Fund for
the establishment, operation, or maintenance of the Museum, without
further Act of appropriation and without fiscal year limitation.
(d) Investment.--
(1) In general.--Upon request of the Commandant, the
Secretary of the Treasury may invest amounts in the Fund in
securities of, or in securities whose principal and interest
are guaranteed by, the United States Government.
(2) Interest.--The interest and profits accruing from
investments under this subsection shall be deposited to the
credit of the Fund.

A: National Coast Guard Museum Act of 2001 - Authorizes the Commandant of the Coast Guard to establish, operate, and maintain a National Coast Guard Museum on Federal lands that are administered by the Coast Guard and specified by the Commandant.Establishes in the Treasury the National Coast Guard Museum Fund.
****
Q: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Lower Prices Reduced with Increased
Competition and Efficient Development of Drugs Act'' or the ''Lower
PRICED Drugs Act''.

SEC. 2. GENERIC DRUG USE CERTIFICATION.

(a) In General.--Section 505(j)(2)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)(2)(A)) is amended--
(1) in clause (vii), by striking ''; and'' and inserting a
semicolon;
(2) in clause (viii), by striking the period and inserting
''; and'';
(3) by inserting after clause (viii) the following:
''(ix) if with respect to a listed drug product referred to
in clause (i) that contains an antibiotic drug and the
antibiotic drug was the subject of any application for
marketing received by the Secretary under section 507 (as in
effect before the date of enactment of the Food and Drug
Administration Modernization Act of 1997) before November 20,
1997, the approved labeling includes a method of use which, in
the opinion of the applicant, is claimed by any patent, a
statement that--
''(I) identifies the relevant patent and the
approved use covered by the patent; and
''(II) the applicant is not seeking approval of
such use under this subsection.''; and
(4) in the last sentence, by striking ''clauses (i) through
(viii)'' and inserting ''clauses (i) through (ix)''.
(b) Effective Date.--The amendments made by this section shall
apply to any abbreviated new drug application under section 505(j) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that is
submitted on, before, or after the date of enactment of this Act.

SEC. 3. PREVENTING ABUSE OF THE THIRTY-MONTH STAY-OF-EFFECTIVENESS
PERIOD.

(a) In General.--Section 505(j)(5)(B)(iii) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iii)) is amended--
(1) in the second sentence by striking ''may order'' and
inserting ''shall order''; and
(2) by adding at the end the following: ''In determining
whether to shorten the thirty-month period under this clause,
the court shall consider the totality of the circumstances,
including whether the plaintiff sought to extend the discovery
schedule, delayed producing discovery, or otherwise acted in a
dilatory manner, and the public interest.''.
(b) Effective Date.--The amendments made by this section shall
apply to any stay of effectiveness period under section
505(j)(5)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(5)(B)(iii)) pending or filed on or after the date of
enactment of this Act.

SEC. 4. ENSURING PROPER USE OF PEDIATRIC EXCLUSIVITY.

(a) Drug Product.--Section 505A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a) is amended by striking ''drug'' each
place it appears and inserting ''drug product''.
(b) Market Exclusivity for New Drugs.--Section 505A(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(b)) is amended--
(1) in the matter preceding paragraph (1), by--
(A) striking ''health'' and inserting
''therapeutically meaningful'';
(B) striking ''and'' after ''(which shall include a
timeframe for completing such studies),''; and
(C) inserting '', and based on the results of such
studies the Secretary approves labeling for the new
drug product that provides specific, therapeutically
meaningful information about the use of the drug
product in pediatric patients'' after ''in accordance
with subsection (d)(3)'';
(2) in paragraph (1)(A)--
(A) in clause (i), by--
(i) striking ''the period'' and inserting
''any period''; and
(ii) inserting ''that is applicable to the
drug product at the time of initial approval''
after ''in subsection (j)(5)(F)(ii) of such
section''; and
(B) in clause (ii), by--
(i) striking ''the period'' and inserting
''any period''; and
(ii) inserting ''that is applicable to the
drug product at the time of initial approval''
after ''of subsection (j)(5)(F) of such
section''; and
(3) in paragraph (2)--
(A) in subparagraph (A)--
(i) in clause (i), by striking ''a listed
patent'' and inserting ''a patent that was
either listed when the pediatric study was
submitted to the Food and Drug Administration
or listed as a result of the approval by the
Food and Drug Administration of new pediatric
labeling that is claimed by the patent, and'';
and
(ii) in clause (ii) by striking ''a listed
patent'' and inserting ''a patent that was
either listed when the pediatric study was
submitted to the Food and Drug Administration
or listed as a result of the approval by the
Food and Drug Administration of new pediatric
labeling that is claimed by the patent, and'';
and
(B) in subparagraph (B), by striking ''a listed
patent'' and inserting ''a patent that was either
listed when the pediatric study was submitted to the
Food and Drug Administration or listed as a result of
the approval by the Food and Drug Administration of new
pediatric labeling that is claimed by the patent,
and''.
(c) Market Exclusivity for Already-Marketed Drugs.--Section 505A(c)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(c)) is
amended--
(1) in the matter preceding paragraph (1), by--
(A) striking ''health'' and inserting
''therapeutically meaningful'';
(B) striking ''and'' after ''the studies are
completed within any such timeframe,''; and
(C) inserting '', and based on the results of such
studies the Secretary approves labeling for the
approved drug product that provides specific,
therapeutically meaningful information about the use of
the drug product in pediatric patients'' after ''in
accordance with subsection (d)(3)'';
(2) in paragraph (1)(A)--
(A) in clause (i)--
(i) by striking ''the period'' and
inserting ''any period''; and
(ii) by inserting ''that is applicable to
the drug product at the time of initial
approval'' after ''in subsection (j)(5)(F)(ii)
of such section''; and
(B) in clause (ii)--
(i) by striking ''the period'' and
inserting ''any period''; and
(ii) by inserting ''that is applicable to
the drug product at the time of initial
approval'' after ''of subsection (j)(5)(F) of
such section''; and
(3) in paragraph (2)--
(A) in subparagraph (A)--
(i) in clause (i), by striking ''a listed
patent'' and inserting ''a patent that was
either listed when the pediatric study was
submitted to the Food and Drug Administration
or listed as a result of the approval by the
Food and Drug Administration of new pediatric
labeling that is claimed by the patent, and'';
and
(ii) in clause (ii), by striking ''a listed
patent'' and inserting ''a patent that was
either listed when the pediatric study was
submitted to the Food and Drug Administration
or listed as a result of the approval by the
Food and Drug Administration of new pediatric
labeling that is claimed by the patent, and'';
and
(B) in subparagraph (B), by striking ''a listed
patent'' and by inserting ''a patent that was either
listed when the pediatric study was submitted to the
Food and Drug Administration or listed as a result of
the approval by the Food and Drug Administration of new
pediatric labeling that is claimed by the patent,
and''.
(d) Three-Month Exclusivity.--Section 505A of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355a) is amended by--
(1) by striking ''six months'' each place it appears and
inserting ''three months'';
(2) by striking ''six-month'' each place it appears and
inserting ''three-month'';
(3) by striking ''6-month'' each place it appears and
inserting ''three-month'';
(4) in subsection (b)(1)(A)(i), by striking ''four and one-
half years, fifty-four months, and eight years, respectively''
and inserting ''four years and three months, fifty-one months,
and seven years and nine months, respectively''; and
(5) in subsection (c)(1)(A)(i), by striking ''four and one-
half years, fifty-four months, and eight years, respectively''
and inserting ''four years and three months, fifty-one months,
and seven years and nine months, respectively''.
(e) Definition.--Section 505A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a) is amended by adding at the end the
following:
''(o) Drug Product.--
''(1) In general.--For purposes of this section, the term
'drug product' has the same meaning given such term in section
314.3(b) of title 21, Code of Federal Regulations (or any
successor regulation).
''(2) Separate drug products.--For purposes of this
section, each dosage form of a drug product shall constitute a
different drug product.''.
(f) Technical Corrections.--Section 505A of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355a) is amended--
(1) by striking ''subsection (c)(3)(D)'' each place it
appears and inserting ''subsection (c)(3)(E)''; and
(2) in subsection (n), by striking ''under subsection (a)
or (c)'' and inserting ''under subsection (b) or (c)''.
(g) Effective Date.--The amendments made by this section shall
apply to requests by the Secretary of Health and Human Services for
pediatric studies under section 505A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a) after the date of enactment of this Act.

SEC. 5. CITIZEN PETITIONS AND PETITIONS FOR STAY OF AGENCY ACTION.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) is amended by adding at the end the following:
''(o) Citizens Petitions and Petitions for Stay of Agency Action.--
With respect to any petition that seeks to have the Secretary take, or
refrain from taking, any form of action relating to the approval of an
application submitted under subsection (b)(2) or (j), the following
shall apply:
''(1) No delay of approval.--The Secretary shall not delay
approval of an application submitted under subsection (b)(2) or
(j) while a petition is reviewed and considered. Consideration
of a petition shall be separate and apart from the review and
approval of an application submitted under either such
subsection.
''(2) Timing of final agency action.--The Secretary shall
take final agency action with respect to a petition within six
months of receipt of that petition. The Secretary shall not
extend such six-month review period, even with consent of the
petitioner, for any reason, including based upon the submission
of comments relating to a petition or supplemental information
supplied by the petitioner. If the Secretary has not taken
final agency action on a petition by the date that is six
months after the date of receipt of the petition, such petition
shall be deemed to have been denied on such date.
''(3) Verification.--The Secretary shall not accept for
review a petition unless it is signed and contains the
following verification: 'I certify that, to my best knowledge
and belief: (a) this petition includes all information and
views upon which the petition relies; (b) this petition
includes representative data and/or information known to the
petitioner which are unfavorable to the petition; and (c) I
have taken reasonable steps to ensure that any representative
data and/or information which are unfavorable to the petition
were disclosed to me. I further certify that the information
upon which I have based the action requested herein first
became known to the party on whose behalf this petition is
filed on or about __________. I verify under penalty of perjury
that the foregoing is true and correct.', with the date of the
filing of such petition inserted in the blank space.
''(4) Extension of period.--The thirty-month period
referred to in subsection (j)(5)(D)(i)(IV) shall automatically
be extended by the amount of time that lapses from the date
that the Secretary receives a petition and the date of final
agency action on that petition, without regard to whether the
Secretary grants, in whole or in part, or denies, in whole or
in part, that petition.''.

A:
Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act or the Lower PRICED Drugs Act - Amends the Federal Food, Drug, and Cosmetic Act to require an abbreviated application for a new drug containing certain antibiotics, the approved labeling for which includes a method of use that is claimed by a patent, to include a statement: (1) that identifies the relevant patent and the approved use covered by the patent; and (2) that the applicant is not seeking approval of such use.

Requires the court to consider the totality of circumstances and the public interest in deciding whether to shorten the 30-month period that delays the approval of an abbreviated drug application when a patent infringement case is filed against the applicant.

Limits market exclusivity provided for conducting pediatric studies of new drugs to only those new drugs for which the Secretary of Health and Human Services approves labeling that contains specific, therapeutically meaningful information about the use of the drug product in pediatric patients.

Prohibits the Secretary from delaying the approval of a new drug application while a petition is reviewed and considered. Requires the Secretary to take final agency action on a petition within six months of receipt, with no extensions allowed. Extends the 30-month period that the Secretary has to approve or disapprove an abbreviated application for a new drug by the amount of time that lapses from the date the Secretary receives a petition and the date of the final agency action on the petition, without regard to whether the Secretary grants or denies the petition.
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