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 ``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.

PROBLEM: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``National Future Farmers of America 
Commemorative Coin Act of 2009''.

SEC. 2. FINDINGS.

    The Congress finds that--
            (1) the National Future Farmers of America Organization 
        makes a positive difference in the lives of students by 
        developing their potential for leadership, personal growth, and 
        career success through agricultural education;
            (2) the National Future Farmers of America Organization was 
        founded in 1928, as the ``Future Farmers of America'', to 
        provide leadership training for high school students of 
        vocational agriculture;
            (3) the National Future Farmers of America Organization 
        created a national agricultural education model for use in 
        public school systems that has been adopted by youth leadership 
        organizations throughout the world;
            (4) the National Future Farmers of America Organization 
        prepares its student members to think critically, work in 
        teams, and be successful in more than 300 careers relating to 
        the science, business, and technology of agriculture;
            (5) approximately 9,000,000 living former members of the 
        National Future Farmers of America Organization are prominent 
        industry executives, members of Congress, community members, 
        farmers, and productive United States citizens;
            (6) in 2009, the National Future Farmers of America 
        Organization had 507,763 members in more than 7,400 local 
        chapters in all 50 States, Puerto Rico, and the United States 
        Virgin Islands;
            (7) the Future Farmers of America was chartered by Congress 
        in 1950, and continues to be an intra-curricular educational 
        organization within public school systems throughout the United 
        States; and
            (8) October 2012 will mark the beginning of a year of 
        celebration in honor of the 85th anniversary of the founding of 
        the National Future Farmers of America Organization, which took 
        place at the first national convention of the National Future 
        Farmers of America Organization.

SEC. 3. COIN SPECIFICATIONS.

    (a) Denominations.--In commemoration of the National Future Farmers 
of America Organization and the 85th anniversary of the National Future 
Farmers of America Organization, the Secretary of the Treasury (in this 
Act referred to as the ``Secretary'') shall mint and issue--
            (1) not more than 100,000 gold coins, which shall--
                    (A) weigh 8.359 grams;
                    (B) have a diameter of 0.850 inches; and
                    (C) contain 90 percent gold and 10 percent alloy; 
                and
            (2) not more than 500,000 silver coins, which shall--
                    (A) weigh 26.7 grams;
                    (B) have a diameter of 1.500 inches; and
                    (C) contain 90 percent silver and 10 percent 
                copper.
    (b) Legal Tender.--The coins minted under this Act shall be legal 
tender, as provided in section 5103 of title 31, United States Code.
    (c) Numismatic Items.--For purposes of sections 5134 and 5136 of 
title 31, United States Code, all coins minted under this Act shall be 
considered to be numismatic items.

SEC. 4. DESIGN OF COINS.

    (a) Design Requirements.--
            (1) In general.--The design of the coins minted under this 
        Act shall be emblematic of the 85-year history of the National 
        Future Farmers of America Organization.
            (2) Designation and inscriptions.--On each coin minted 
        under this Act, there shall be--
                    (A) a designation of the value of the coin;
                    (B) inscriptions of the words ``Liberty'', ``In God 
                We Trust'', ``United States of America'', and ``E 
                Pluribus Unum''; and
                    (C) an inscription of the year 2012.
    (b) Selection.--The design for the coins minted under this Act 
shall be--
            (1) selected by the Secretary, after consultation with the 
        National Future Farmers of America Organization and the 
        Commission of Fine Arts; and
            (2) reviewed by the Citizens Coinage Advisory Committee.

SEC. 5. ISSUANCE OF COINS.

    (a) Quality of Coins.--Coins minted under this Act shall be issued 
in uncirculated and proof qualities.
    (b) Period of Issuance.--The Secretary may issue coins under this 
Act only for the 1-year period beginning on January 1, 2012.

SEC. 6. SALE OF COINS.

    (a) Sale Price.--The coins minted under this Act shall be sold by 
the Secretary at a price equal to the sum of--
            (1) the face value of the coins;
            (2) the surcharge provided in section 7 with respect to 
        such coins; and
            (3) the cost of designing and minting the coins (including 
        labor, materials, dies, use of machinery, overhead expenses, 
        marketing, and shipping).
    (b) Bulk Sales.--The Secretary shall make bulk sales of the coins 
minted under this Act at a reasonable discount.
    (c) Prepaid Orders.--
            (1) In general.--The Secretary shall accept prepaid orders 
        for the coins minted under this Act before the issuance of such 
        coins.
            (2) Discount.--Sale prices with respect to prepaid orders 
        under paragraph (1) shall be at a reasonable discount.

SEC. 7. SURCHARGES.

    (a) In General.--All sales of coins minted under this Act shall 
include a surcharge of $25 per gold coin and $10 per silver coin.
    (b) Distribution.--Subject to section 5134(f) of title 31, United 
States Code, the Secretary shall pay all of the surcharges received by 
the Secretary from the sale of coins minted under this Act to the 
National Future Farmers of America Foundation in Indianapolis, Indiana, 
for the creation of an endowment to enhance and expand programs that 
encourage the development of leadership skills, personal growth, and 
career success through agricultural education and the Future Farmers of 
America.
    (c) Audits.--The Comptroller General of the United States is 
authorized to examine such books, records, documents, and other data of 
the organization described in subsection (b) as may be related to the 
expenditures of amounts paid under subsection (b).

SOLUTION: National Future Farmers of America Commemorative Coin Act of 2009 - Directs the Secretary of the Treasury to mint and issue gold and silver coins in commemoration of the National Future Farmers of America Organization and the 85th anniversary of such Organization.

Authorizes the issuance of coins under this Act only for a one year period, beginning on January 1, 2012.

Requires all sales of coins minted under this Act to include a surcharge of $25 per gold coin and $10 per silver coin.

Requires all of the surcharges received from the sale of such coins to be paid to the National Future Farmers of America Foundation in Indianapolis, Indiana, for the creation of an endowment to enhance and expand programs that encourage the development of leadership skills, personal growth, and career success through agricultural education and the Future Farmers of America.

PROBLEM: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Agricultural Trade Facilitation 
Act''.

SEC. 2. CONGRESSIONAL FINDINGS.

    Congress finds the following:
            (1) Pursuant to article I, section 8, clause 3 of the 
        Constitution of the United States, Congress has the authority 
        to establish negotiating objectives for the United States for 
        agreements related to agricultural trade.
            (2) From 2008 to 2010, the value of United States 
        agricultural exports averaged nearly $107 billion annually. 
        Compared to 1998 to 2000, when the total value of agricultural 
        exports averaged $51,000,000,000 annually, United States 
        agricultural exports have more than doubled in past ten years.
            (3) The Department of Agriculture's Economic Research 
        Service reports that each $1,000,000,000 in United States 
        agricultural exports supports approximately 8,400 jobs. The 
        Economic Research Service further reports that United States 
        agricultural exports supported nearly 830,000 full-time 
        American jobs both on and off-farm in 2009.
            (4) Even as the importance of agricultural exports to the 
        United States economy grows, there are continued reports that 
        non science-based sanitary and phytosanitary measures are 
        restricting trade, acting as non-tariff barriers to trade. The 
        elimination and reduction of unwarranted sanitary and 
        phytosanitary barriers to trade will increase United States 
        agricultural exports and jobs.
            (5) Sanitary and phytosanitary measures are those designed 
        ``to protect human, animal or plant life or health from risks'' 
        arising from additives, contaminants, pests, toxins, diseases, 
        or disease-carrying and causing organisms in foods, beverages, 
        feedstuffs, animals, or plants. Sanitary and phytosanitary 
        measures can take such forms as specific product or processing 
        standards, requirements for products to be produced in disease-
        free areas, quarantine regulations, certification or inspection 
        procedures, sampling and testing requirements, health-related 
        labeling measures, maximum permissible pesticide residue 
        levels, and prohibitions on certain food additives.
            (6) There are currently 37 active disputes involving 
        sanitary and phytosanitary measures being argued within the 
        World Trade Organization (WTO) between Member countries. These 
        cases have been invoked under the WTO Agreement on the 
        Application of Sanitary and Phytosanitary Measures.
            (7) While the Agreement on the Application of Sanitary and 
        Phytosanitary Measures, to which all WTO Member countries are 
        parties, explicitly recognizes the rights of each country to 
        take their own measures, they must be science-based and applied 
        only to the extent necessary to protect human, animal or plant 
        health, and cannot be arbitrary or used to unjustifiably 
        discriminate domestically or between trading partners. Member 
        countries are also encouraged to observe established and 
        recognized international standards. Improper use of measures 
        can create substantial, if not complete, barriers to United 
        States exports when they are disguised barriers to trade, are 
        not supported by science, or are otherwise unwarranted.
            (8) In 2010, a United States interagency group led by the 
        Department of Agriculture's Foreign Agricultural Service, 
        reviewed more than 1,000 notifications from 50 countries as 
        required under the Agreement on the Application of Sanitary and 
        Phytosanitary Measures. The United States Government commented 
        on 173 proposed or in-force sanitary and phytosanitary 
        measures. Nearly one-half of the comments were measures 
        regarding processed products, one-third addressed requirements 
        for live animals and fish (and their products, including dairy 
        products); and almost one-quarter were for measures that 
        introduced new standards or entry requirements for plants, bulk 
        commodities (including those made with biotechnology), and 
        horticultural products.
            (9) Each year, the United States Trade Representative 
        reports that non science-based sanitary and phytosanitary trade 
        barriers continue to threaten, constrain, or block United 
        States agricultural exports.
            (10) A Department of Agriculture study of the impact of 
        foreign technical trade barriers on United States agricultural 
        exports reported the presence of ``questionable technical 
        barriers'' in more than 60 countries affecting trade in more 
        than 300 agricultural products, valued at an estimated $5 
        billion of United States agricultural, forestry, and fishery 
        exports using 1996 data, accounting for about 7 percent of 
        total agricultural exports during that year. Although more 
        recent formal estimates of United States agricultural trade 
        effects are not available, the United States Trade 
        Representative continues to assert: ``[Sanitary and 
        phytosanitary] trade barriers prevent U.S. producers from 
        shipping hundreds of millions of dollars worth of goods, 
        hurting farms and small businesses''.
            (11) The improper use of sanitary and phytosanitary trade 
        barriers to trade can be reduced through achieving and 
        implementing agreements that provide for enhanced 
        harmonization, transparency, equivalency, improved regulatory 
        practices, and more efficient and effective dispute settlement. 
        The elimination and reduction in use of such barriers to trade 
        will strengthen the international trading system by providing 
        certainty, predictability, and fair treatment.
            (12) The Agreement on the Application of Sanitary and 
        Phytosanitary Measures has proven valuable to United States 
        exporters, but experience has exposed certain inadequacies in 
        its rules.
            (13) Accordingly, as the United States prepares for future 
        trade agreements, the Administration must prioritize further 
        strengthening of rules on sanitary and phytosanitary measures.

SEC. 3. TRADE NEGOTIATING OBJECTIVES OF THE UNITED STATES WITH RESPECT 
              TO THE APPLICATION OF SANITARY AND PHYTOSANITARY MEASURES 
              TO AGRICULTURAL PRODUCTS.

    (a) Overall Trade Negotiating Objectives.--The overall trade 
negotiating objective of the United States with respect to the 
application of sanitary and phytosanitary measures to agricultural 
products for trade agreements between the United States and foreign 
countries is to secure more open, equitable, and reciprocal market 
access by strengthening the rules governing the application of sanitary 
and phytosanitary measures to agricultural products.
    (b) Principal Trade Negotiating Objectives.--The principal trade 
negotiating objectives of the United States with respect to the 
application of sanitary and phytosanitary measures to agricultural 
products are the following:
            (1) To strengthen the requirement that the application of 
        measures is based on scientific evidence by requiring parties 
        to the agreement to make available their risk assessments and 
        provide a science-based justification for regulations, in 
        particular in cases in which measures are more restrictive than 
        international standards.
            (2) To encourage parties to the agreement to participate 
        actively in the development of international standards relating 
        to the application of measures and to apply those standards 
        whenever it is appropriate to do so and to require parties to 
        provide a scientific justification whenever they apply a 
        standard that deviates from an established international 
        standard.
            (3) To improve regulatory coherence and increase the use of 
        systems-based approaches, to require parties to the agreement 
        to evaluate on a timely basis the health and safety protection 
        systems of other parties and to allow imports of products if 
        the system of the exporting party meets or exceeds the end-
        product standards of the importing party.
            (4) To require greater transparency in the development and 
        implementation of the measures, to require parties to the 
        agreement to publish proposed measures, including a scientific 
        justification, to provide an opportunity for interested parties 
        to comment on the proposal, and to take into account reasonable 
        concerns, and to require parties to provide significant advance 
        notice before implementing new, non-emergency measures in order 
        to provide ample time for any necessary adjustments by industry 
        in order to come into compliance.
            (5) To require parties to the agreement to carry out risk 
        analysis in a timely manner consistent with the guidelines 
        developed by relevant international organizations, to ensure 
        that risk assessments are based on the most relevant scientific 
        data, to require parties to consider the full range of risk 
        management options and to ensure that the measures are no more 
        trade-restrictive than necessary to meet the intended purpose, 
        and to require effective risk communication.
            (6) To improve rules governing the testing of imported 
        products, to require importing parties to use validated test 
        methods and to provide importers with the right to a 
        confirmatory test, and to provide the right of appeal.
            (7) To promote the harmonization of export certification 
        requirements and to require that parties to the agreement limit 
        information requirements on export documents to that which is 
        necessary to determine whether a product meets sanitary and 
        phytosanitary standards.
            (8) To ensure that new sanitary and phytosanitary trade 
        obligations are fully enforceable through an a more efficient 
        and effective dispute settlement process.

SEC. 4. EFFECTIVE DATE.

    (a) In General.--Except as provided in subsection (b), this Act 
takes effect on the date of the enactment of this Act and applies with 
respect to negotiations entered into before, on, or after such date of 
enactment for any trade agreement relating to the application of 
sanitary and phytosanitary measures to agricultural products.
    (b) Exception.--This Act does not apply with respect to 
negotiations for any of the following:
            (1) The United States-Colombia Trade Promotion Agreement.
            (2) The United States-Korea Free Trade Agreement.
            (3) The United States-Panama Trade Promotion Agreement.
            (4) The Doha Development Round of the World Trade 
        Organization.

SOLUTION:
Agricultural Trade Facilitation Act - States that the overall trade negotiating objective of the United States with respect to the application of sanitary and phytosanitary measures to agricultural products for trade agreements between the United States and foreign countries is to secure more open and reciprocal market access by strengthening the rules governing such measures' application to agricultural products.

States that the principal trade negotiating objectives of the United States with respect to the application of sanitary and phytosanitary measures to agricultural products are to: (1) strengthen the requirement that the application of such measures is based on scientific evidence, (2) encourage parties to an agreement to participate actively in the development of international standards relating to such measures' application, (3) improve regulatory coherence and increase the use of systems-based approaches, (4) require greater transparency in such measures' development and implementation, (5) require parties to an agreement to carry out risk analysis in a timely manner consistent with international guidelines, (6) improve rules governing the testing of imported products, (7) promote harmonization of export certification requirements, and (8) ensure that new sanitary and phytosanitary trade obligations are fully enforceable through an effective dispute settlement process.

Makes this Act inapplicable to negotiations for: (1) The United States-Colombia Trade Promotion Agreement, (2) The United States-Korea Free Trade Agreement, (3) The United States-Panama Trade Promotion Agreement, and (4) The Doha Development Round of the World Trade Organization.