TASK DEFINITION: In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
PROBLEM: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Citizen Petition Fairness and
Accuracy Act of 2006''.

SEC. 2. CITIZEN PETITIONS AND PETITIONS FOR STAY OF AGENCY ACTION.

Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(5)) is amended by adding at the end the following:
''(G)(i) Notwithstanding any other provision of law, any petition
submitted under section 10.30 or section 10.35 of title 21, Code of
Federal Regulations (or any successor regulation), shall include a
statement that to the petitioner's best knowledge and belief, the
petition--
''(I) includes all information and views on which the
petitioner relies, including all representative data and
information known to the petitioner that is favorable or
unfavorable to the petition;
''(II) is well grounded in fact and is warranted by law;
''(III) is not submitted for an improper purpose, such as
to harass or cause unnecessary delay (including unnecessary
delay of competition or agency action); and
''(IV) does not contain a materially false, misleading, or
fraudulent statement.
''(ii) The Secretary shall investigate, on receipt of a complaint,
a request under clause (vi), or on its own initiative, any petition
submitted under such section 10.30 or section 10.35 (or any successor
regulation), that--
''(I) does not comply with the requirements of clause (i);
''(II) may have been submitted for an improper purpose as
described in clause (i)(III); or
''(III) may contain a materially false, misleading, or
fraudulent statement as described in clause (i)(IV).
''(iii) If the Secretary finds that the petitioner has knowingly
and willingly submitted the petition for an improper purpose as
described in clause (i)(III), or which contains a materially false,
misleading, or fraudulent statement as described in clause (i)(IV), the
Secretary may--
''(I) impose a civil penalty of not more than $1,000,000,
plus attorneys fees and costs of reviewing the petition and any
related proceedings;
''(II) suspend the authority of the petitioner to submit a
petition under such section 10.30 or section 10.35 (or any
successor regulation), for a period of not more than 10 years;
''(III) revoke permanently the authority of the petitioner
to submit a petition under such section 10.30 or section 10.35
(or any successor regulation); or
''(IV) dismiss the petition at issue in its entirety.
''(iv) If the Secretary takes an enforcement action described in
subclause (I), (II), (III), or (IV) of clause (iii) with respect to a
petition, the Secretary shall refer that petition to the Federal Trade
Commission for further action as the Federal Trade Commission finds
appropriate.
''(v) In determining whether to take an enforcement action
described in subclause (I), (II), (III), or (IV) of clause (iii) with
respect to a petition, and in determining the amount of any civil
penalty or the length of any suspension imposed under that clause, the
Secretary shall consider the specific circumstances of the situation,
such as the gravity and seriousness of the violation involved, the
amount of resources expended in reviewing the petition at issue, the
effect on marketing of competing drugs of the pendency of the
improperly submitted petition, including whether the timing of the
submission of the petition appears to have been calculated to cause
delay in the marketing of any drug awaiting approval, and whether the
petitioner has a history of submitting petitions in violation of this
subparagraph.
''(vi)(I) Any person aggrieved by a petition filed under such
section 10.30 or section 10.35 (or any successor regulation), including
a person filing an application under subsection (b)(2) or (j) of this
section to which such petition relates, may request that the Secretary
initiate an investigation described under clause (ii) for an
enforcement action described under clause (iii).
''(II) The aggrieved person shall specify the basis for its belief
that the petition at issue is false, misleading, fraudulent, or
submitted for an improper purpose. The aggrieved person shall certify
that the request is submitted in good faith, is well grounded in fact,
and not submitted for any improper purpose. Any aggrieved person who
knowingly and intentionally violates the preceding sentence shall be
subject to the civil penalty described under clause (iii)(I).
''(vii) The Secretary shall take final agency action with respect
to a petition filed under such section 10.30 or section 10.35 (or any
successor regulation) within 6 months of receipt of such petition. The
Secretary shall not extend such 6-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 6 months after
the date of receipt of the petition, such petition shall be deemed to
have been denied on such date.
''(viii) The Secretary may promulgate regulations to carry out this
subparagraph, including to determine whether petitions filed under such
section 10.30 or section 10.35 (or any successor regulation) merit
enforcement action by the Secretary under this subparagraph.''.

SOLUTION: Citizen Petition Fairness and Accuracy Act of 2006 - Amends the Federal Food, Drug, and Cosmetic Act to require that any citizen petition or request for stay of action related to an abbreviated new drug application include a statement that the petition: (1) includes all information and views on which the petitioner relies; (2) is well grounded in fact and warranted by law; (3) is not submitted for an improper purpose; and (4) does not contain a materially false, misleading, or fraudulent statement. Requires the Secretary of Health and Human Services to investigate any petition that does not comply.

Allows the Secretary to impose penalties for knowingly and willfully submitting a petition for an improper purpose or that contains a materially false, misleading, or fraudulent statement. Provides that such penalties may include: (1) civil penalty; (2) suspension or revocation of the authority to submit a petition; and (3) dismissal of the petition. Requires the Secretary to refer such a violative petition to the Federal Trade Commission (FTC) for further action. Sets forth the factors that the Secretary shall consider in taking an enforcement action or determining the penalty.

Permits any person aggrieved by a petition that may contain violations to request the Secretary to investigate. Subjects knowing and intentional violative requests to civil penalties.

Requires the Secretary to take final agency action on such a petition within six months.

PROBLEM: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Lewis and Clark Voyage of Scientific
Discovery Act''.

SEC. 2. LONG-TERM MONITORING PROGRAM.

(a) Establishment.--Not later than 2 years after the date of the
enactment of this Act, the Secretary of the Interior, in consultation
with the Director of the United States Geological Survey, shall
establish a program at the River Studies Center of the Biological
Resources Division of the United States Geological Survey, located in
Columbia, Missouri--
(1) to determine and monitor the biological and chemical
characteristics of the Missouri River;
(2) to determine and monitor the interrelationship of those
characteristics with the hydrology and geomorphology of the
river; and
(3) to monitor and assess the biota, including threatened
or endangered species, habitats, and water quality of the
Missouri River.
(b) Development.--To develop the program, the Secretary of the
Interior and the Director of the United States Geological Survey shall
consult with--
(1) the Governors of affected States, acting through--
(A) the Missouri River Natural Resources Committee;
and
(B) the Missouri River Basin Association; and
(2) the Secretary of Agriculture;
(3) the Secretary of the Army;
(4) the Western Area Power Administration;
(5) the Administrator of the Environmental Protection
Agency; and
(6) the Missouri River Basin Tribes.
(c) Activities.--The program under subsection (b) shall provide
scientific information to--
(1) guide operation and management of the Missouri River;
and
(2) measure and model the impact of management alternatives
through--
(A) monitoring of biota, including threatened or
endangered species, habitats, and water quality;
(B) focused investigations of cause and effect
relationships; and
(C) identification and evaluation of methods to
conserve fish and wildlife, including threatened and
endangered species.
(d) Baseline.--The program under subsection (b) shall establish a
baseline of conditions against which future activities can be measured.
(e) Database.--The Secretary of the Interior shall--
(1) establish a database on Missouri River biota, including
threatened or endangered species, habitats, and water quality;
and
(2) make the database readily available to the public.
(f) Report.--Not later than 3 years after the date of establishment
of the program under subsection (b), and not less frequently than every
3 years thereafter, the Secretary of the Interior, acting through the
Director of the United States Geological Survey, shall--
(1) review the program;
(2) as necessary, establish and revise the objectives of
the program; and
(3) submit to Congress a report on the environmental health
of the Missouri River.
(g) Indian Tribes.--Notwithstanding any other provision of law, the
Secretary of the Interior shall enter into contracts, pursuant to the
Indian Self Determination Act (title I of the Indian Self Determination
and Education Assistance Act; 25 U.S.C. chapter 14, subchapter II, part
A (25 U.S.C. 450f et. seq.)) with Tribes whose Reservations are located
along the Missouri River and have an interest in environmental
restoration. The tasks to be contracted shall implement the goals set
forth in this section and shall complement the activities undertaken by
the Secretary of the Interior and the affected State Governments.
(h) Authorization of Appropriations.--
(1) In general.--There are authorized to be appropriated to
the Secretary of the Interior to carry out this section--
(A) $6,500,000 for fiscal year 2002;
(B) $8,500,000 for fiscal year 2003; and
(C) $15,100,000 for each of fiscal years 2004
through 2016.
(2) Allocation of funds.--Funding of the program shall be
implemented in the following manner:
(A) Not more than the following percentage of the
funds available shall be directed to the River Studies
Center of the Biological Resources Division of the
United States Geological Survey, located in Columbia,
Missouri:
(i) 25 percent in fiscal year 2002
(ii) 40 perccent in fiscal year 2003
(iii) 65 percent in fiscal years after
2003.
At least 50 percent of such funds shall be directed to
the River Studies Center in fiscal years after 2003.
(B) The remaining funds shall be made available to
State fish and wildlife agencies in the Missouri River
basin to conduct monitoring activities designed to
enhance and supplement existing scientific knowledge of
the Missouri River system.
(3) Threatened and endangered species.--Of the amounts made
available under paragraph (1) for each fiscal year, $1,500,000
shall be made available to the Secretary of the Interior and
the State agencies with jurisdiction for Missouri River fish
and wildlife to monitor and conduct focused investigations of
endangered fish, including pallid sturgeon response to main
stem reservoir operations.
(4) State agency funding.--Funds authorized to be
appropriated under this section shall be made available as
necessary to contract with the State agencies with jurisdiction
for Missouri River fish and wildlife to collect field data and
support field operations for the monitoring component of the
program.
(5) Funding of focused investigations.--The focused
investigations component of the program established under this
section shall be funded using a competitive process. Each year,
the directors of the State fish and game agencies with
jurisdiction for Missouri River fish and wildlife, in
consultation with the Secretary of the Interior, and the
entities listed under section 2(b)(1), shall prioritize
information needs and issue a request for proposals to State,
Federal, for-profit, and not-for-profit organizations with
Missouri River interest and expertise. The directors and the
Secretary shall review and select those proposals to be funded.

SOLUTION: Lewis and Clark Voyage of Scientific Discovery Act - Directs the Secretary of the Interior to establish a program at the River Studies Center of the Biological Resources Division of the United States Geological Survey in Columbia, Missouri, to determine and monitor the biological and chemical characteristics of the Missouri River, determine and monitor the relationship of those characteristics with the river's hydrology and geomorphology, and monitor and assess the river's biota and water quality. Requires contracts with Indian tribes whose reservations are located along the Missouri River and have an interest in environmental restoration.Requires establishment of a publicly available database.Makes a specified amount of funds provided under this Act available to monitor and conduct focused investigations of endangered fish, including pallid sturgeon.

PROBLEM: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Protecting Consumer Access to
Generic Drugs Act of 2007''.

SEC. 2. UNFAIR AND DECEPTIVE ACTS AND PRACTICES RELATED TO NEW DRUG
APPLICATIONS.

(a) Conduct Prohibited.--It shall be unlawful for any person to
directly or indirectly be a party to any agreement resolving or
settling a patent infringement claim in which--
(1) an ANDA filer receives anything of value; and
(2) the ANDA filer agrees not to research, develop,
manufacture, market, or sell, for any period of time, the drug
that is to be manufactured under the ANDA involved and is the
subject of the patent infringement claim.
(b) Exceptions.--Notwithstanding subsection (a)(1), subsection (a)
does not prohibit a resolution or settlement of a patent infringement
claim in which the value received by the ANDA filer includes no more
than--
(1) the right to market the drug that is to be manufactured
under the ANDA involved and is the subject of the patent
infringement claim, before the expiration of--
(A) the patent that is the basis for the patent
infringement claim; or
(B) any other statutory exclusivity that would
prevent the marketing of such drug; and
(2) the waiver of a patent infringement claim for damages
based on prior marketing of such drug.
(c) Enforcement.--A violation of subsection (a) shall be treated as
an unfair and deceptive act or practice and an unfair method of
competition in or affecting interstate commerce prohibited under
section 5 of the Federal Trade Commission Act (15 U.S.C. 45). The
Federal Trade Commission shall enforce this Act in the same manner, by
the same means, and with the same jurisdiction as though all applicable
terms and provisions of the Federal Trade Commission Act were
incorporated into and made a part of this Act.
(d) Definitions.--In this section:
(1) Agreement.--The term ''agreement'' means anything that
would constitute an agreement for purposes of section 5 of the
Federal Trade Commission Act (15 U.S.C. 45).
(2) Agreement resolving or settling.--The term ''agreement
resolving or settling'', in reference to a patent infringement
claim, includes any agreement that is contingent upon, provides
a contingent condition for, or is otherwise related to the
resolution or settlement of the claim.
(3) ANDA.--The term ''ANDA'' means an abbreviated new drug
application for the approval of a new drug under section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).
(4) ANDA filer.--The term ''ANDA filer'' means a party that
has filed an ANDA with the Food and Drug Administration.
(5) Patent infringement.--The term ''patent infringement''
means infringement of any patent or of any filed patent
application, extension, reissuance, renewal, division,
continuation, continuation in part, reexamination, patent term
restoration, patent of addition, or extension thereof.
(6) Patent infringement claim.--The term ''patent
infringement claim'' means any allegation made to an ANDA
filer, whether or not included in a complaint filed with a
court of law, that its ANDA or drug to be manufactured under
such ANDA may infringe any patent.

SEC. 3. FTC RULEMAKING.

The Federal Trade Commission may, by rule promulgated under section
553 of title 5, United States Code, exempt certain agreements described
in section 2 if the Commission finds such agreements to be in
furtherance of market competition and for the benefit of consumers.
Consistent with the authority of the Commission, such rules may include
interpretive rules and general statements of policy with respect to the
practices prohibited under section 2.

SEC. 4. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD UNDER THE FFDCA.

Section 505(j)(5)(D)(i) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)(5)(D)(i)) is amended--
(1) in subclause (I)(bb)--
(A) by redesignating subitem (CC) as subitem (EE);
and
(B) by inserting after subitem (BB) the following:

''(CC) In a
declaratory judgment
action described in
subitem (AA), a court
dismisses the action
for lack of subject
matter jurisdiction,
either with or without
prejudice.

''(DD) The
applicant files with
the Secretary a
covenant by the patent
owner that the patent
owner will not sue the
applicant for
infringement with
respect to the
patent.''; and

(2) in subclause (V), by inserting ''section 2 of the
Protecting Consumer Access to Generic Drugs Act of 2007 or''
after ''that the agreement has violated''.

SEC. 5. NOTICE AND CERTIFICATION OF AGREEMENTS.

(a) Notice of All Agreements.--Section 1112(c)(2) of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (21
U.S.C. 3155 note) is amended by--
(1) striking ''the Commission the'' and inserting ''the
Commission (1) the''; and
(2) inserting before the period at the end the following:
''; and (2) a description of the subject matter of any other
agreement the parties enter into within 30 days of an entering
into an agreement covered by subsection (a) or (b)''.
(b) Certification of Agreements.--Section 1112 of such Act is
amended by adding at the end the following:
''(d) Certification.--The Chief Executive Officer or the company
official responsible for negotiating any agreement required to be filed
under subsection (a), (b), or (c) shall execute and file with the
Assistant Attorney General and the Commission a certification as
follows: 'I declare under penalty of perjury that the following is true
and correct: The materials filed with the Federal Trade Commission and
the Department of Justice under section 1112 of subtitle B of title XI
of the Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, with respect to the agreement referenced in this
certification: (1) represent the complete, final, and exclusive
agreement between the parties; (2) include any ancillary agreements
that are contingent upon, provide a contingent condition for, or are
otherwise related to, the referenced agreement; and (3) include written
descriptions of any oral agreements, representations, commitments, or
promises between the parties that are responsive to subsection (a) or
(b) of such section 1112 and have not been reduced to writing.'.''.

SOLUTION:
Protecting Consumer Access to Generic Drugs Act of 2007 - Prohibits, as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce, any person from being a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market or sell the generic drug. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period; or (2) the waiver of a patent infringement claim for damages.

Authorizes the Federal Trade Commission (FTC) to exempt agreements in furtherance of market competition and for the benefit of consumers.

Amends the Federal Food, Drug, and Cosmetic Act to provide that a generic drug applicant forfeits market exclusivity for failing to market the drug 75 days after: (1) a court dismisses a declaratory judgment action for lack of subject matter jurisdiction; or (2) the applicant files with the Secretary of Health and Human Services a covenant that the patent owner will not sue the applicant for patent infringement. Deems an applicant to have forfeited market exclusivity if the applicant enters into an agreement that violates this Act.

Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to revise reporting requirements related to agreements between a generic drug applicant and a brand name drug company to include: (1) a description of the subject matter of other agreements between the parties; and (2) a certification that the materials filed represent the complete, final, and exclusive agreement between the parties.