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 ``Major Regulation Cost Review Act of 
2004''.

SEC. 2. REQUIREMENT FOR PERIODIC REVIEW OF ALL MAJOR RULES.

    (a) Requirement.--Chapter 6 of title 5, United States Code, is 
amended by inserting after section 610 the following new section:
``Sec. 610a. Periodic review of major rules
    ``(a)  Requirement for Review of Major Rules.--Not later than 180 
days after the date of the enactment of the Major Regulation Cost 
Review Act of 2004, each agency shall publish in the Federal Register a 
plan for the periodic review of all the major rules issued by the 
agency. Such plan may be amended by the agency at any time by 
publishing the revision in the Federal Register.
    ``(b) Purpose of Review.--The purpose of the review shall be to 
determine whether such rules should be continued without change, or 
should be amended or rescinded, consistent with the stated objectives 
of applicable statutes.
    ``(c) Review Within Five Years.--The plan shall provide for the 
review of all such agency rules existing on the effective date of the 
Major Regulation Cost Review Act of 2004 within five years after that 
date and for the review of such rules adopted after such effective date 
within five years after the publication of such rules as the final 
rule. If the head of the agency determines that completion of the 
review of existing rules is not feasible by the established date, the 
head of the agency shall so certify in a statement published in the 
Federal Register and may extend the completion date by one year at a 
time for a total of not more than five years.
    ``(d) Factors to Consider.--In reviewing major rules in a manner 
consistent with the stated objectives of applicable statutes, the 
agency shall consider the following factors:
            ``(1) The continued need for the rule.
            ``(2) The nature of complaints or comments received 
        concerning the rule from the public.
            ``(3) The complexity of the rule.
            ``(4) The extent to which the rule overlaps, duplicates, or 
        conflicts with other Federal rules, and, to the extent 
        feasible, with State and local governmental rules.
            ``(5) The length of time since the rule has been evaluated 
        or the degree to which technology, economic conditions, or 
        other factors have changed in the area affected by the rule.
    ``(e) Cost-Benefit Analysis.--The review shall include a cost-
benefit analysis of the rule, using the standard cost-benefit 
methodology included in Office of Management and Budget Circular A-4 
(relating to regulatory analysis and issued September 17, 2003). The 
cost-benefit analysis shall include an identification and consideration 
of a range of less costly regulatory alternatives.
    ``(f) Publication of List of Rules to Be Reviewed.--Each year, each 
agency shall publish in the Federal Register a list of the major rules 
which are to be reviewed pursuant to this section during the succeeding 
12 months and which are to be included in the accounting statement and 
associated report submitted to Congress by the Director of the Office 
of Management and Budget under paragraph (4) of section 624(a) of the 
Treasury and General Government Appropriations Act, 2001 (as added by 
section 3 of the Major Regulation Cost Review Act of 2004). The list 
shall include a brief description of each such major rule and the need 
for and legal basis of such rule, and shall invite public comment upon 
the rule.
    ``(g) Major Rule Defined.--In this section, the term `major rule' 
has the meaning provided by section 804 of this title.''.
    (b) Clerical Amendment.--The table of sections for chapter 6 of 
title 5, United States Code, is amended by inserting after the item 
relating to section 610 the following new item:

``610a. Periodic review of major rules.''.

SEC. 3. REQUIREMENTS FOR OMB RELATING TO ANNUAL ACCOUNTING STATEMENT.

    (a) Requirement to Include List of Rules to Be Reviewed in Annual 
Accounting Statement.--Section 624(a) of the Treasury and General 
Government Appropriations Act, 2001 (as enacted into law by Public Law 
106-554; 114 Stat. 2763A-161), is amended--
            (1) by striking ``and'' at the end of paragraph (2);
            (2) by striking the period at the end of paragraph (3) and 
        inserting ``; and''; and
            (3) by adding at the end the following new paragraph:
            ``(4) a list of the major rules which are to be reviewed by 
        each agency, during the year following the year in which the 
        statement and report are submitted, pursuant to section 610a of 
        title 5, United States Code.''.
    (b) Requirement to Use Agency Cost-Benefit Estimates in Annual 
Accounting Statement.--Section 624 of the Treasury and General 
Government Appropriations Act, 2001 (as enacted into law by Public Law 
106-554; 114 Stat. 2763A-161), is amended--
            (1) by redesignating subsections (b), (c), and (d) as 
        subsections (c), (d), and (e), respectively; and
            (2) by inserting after subsection (a) the following new 
        subsection:
    ``(b) Use of Agency Cost-Benefit Analyses Required.--To carry out 
subsection (a), the Director of the Office of Manage

SOLUTION: Major Regulation Cost Review Act of 2004 - Amends Federal civil service law to require each Federal agency to publish in the Federal Register a plan, which may be amended at any time by publishing a revision, for the periodic review of all the major rules issued by the agency. Requires that the plan provide for review within five years after publication as a final rule, with a five year extension permitted.

Directs the agency, in reviewing major rules, to consider: (1) the continued need for the rule; (2) the nature of complaints or comments received from the public concerning the rule; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal rules, and with State and local governmental rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule.

Requires that: (1) the review include a cost-benefit analysis of the rule, including an identification and consideration of a range of less costly regulatory alternatives; and (2) each year each agency publish a list of the major rules which are to be reviewed and which are to be included in the accounting statement and associated report submitted to Congress by the Director of the Office of Management and Budget.

Makes conforming changes to the Treasury and General Government Appropriations Act, 2001.

PROBLEM: SECTION 1. FINDINGS.

    Congress finds the following:
            (1) Article I, section 8 of the Constitution vests solely 
        in Congress the power to declare war.
            (2) The Constitution provides the President with the power 
        to act as Commander-in-Chief and with the limited power to 
        utilize the United States Armed Forces to ``repel sudden 
        attacks''.
            (3) The constitutional authority of Congress to declare 
        war, and the requirement that the President seek Congress' 
        express prior statutory authorization to deploy United States 
        Armed Forces are necessary to ensure the collective judgment of 
        both Congress and the executive branch in making the decision 
        to deploy United States Armed Forces abroad.
            (4) In a May 21, 2011, letter, President Obama notified 
        congressional leaders that United States military forces had 
        been deployed to Libya at his direction ``to assist an 
        international effort authorized by the United Nations Security 
        Council'', and that ``United Nations Security Council 
        Resolution 1973 authorized Member States, under Chapter VII of 
        the U.N. Charter, to take all necessary measures to protect 
        civilians and civilian populated areas under threat of attack 
        in Libya, including the establishment and enforcement of a `no-
        fly zone' in the airspace of Libya.''.
            (5) In a May 20, 2011, letter to congressional leaders, 
        President Obama wrote that he ``reported to the Congress that 
        the United States, pursuant to a request from the Arab League 
        and authorization by the United Nations Security Council, had 
        acted 2 days earlier to prevent a humanitarian catastrophe by 
        deploying U.S. forces to protect the people of Libya from the 
        Qaddafi regime.''.
            (6) Section 8(a)(2) of the War Powers Resolution 
        specifically states that the authority to introduce United 
        States Armed Forces into hostilities ``shall not be inferred . 
        . . from any treaty heretofore or hereafter ratified unless 
        such treaty is implemented by legislation specifically 
        authorizing the introduction of United States Armed Forces into 
        hostilities or into such situations and stating that it is 
        intended to constitute specific statutory authorization within 
        the meaning of this joint resolution.''.
            (7) Section 2(c) of the War Powers Resolution acknowledged 
        the constitutional powers of President as Commander-in-Chief to 
        introduce forces into hostilities or imminent hostilities as 
        ``exercised only pursuant to a declaration of war, specific 
        statutory authorization, or a national emergency created by 
        attack upon the United States, its territories or possessions, 
        or its armed forces.''.
            (8) The War Powers Resolution was passed by Congress over a 
        presidential veto in the aftermath of the Vietnam war, to 
        ensure that Congress had a direct role in the decision to 
        introduce United States Armed Forces into hostilities.
            (9) The introduction of United States Armed Forces into 
        hostilities authorized by the United Nations or any other 
        international body aside from the United States Congress is no 
        substitute for a congressional declaration of war or 
        authorization for the use of force.

SEC. 2. STATEMENT OF POLICY.

    It should be the policy of the United States--
            (1) to protect the role of Congress as a coequal branch of 
        government and ensure the protection of its constitutional 
        authority to declare war and support the Armed Forces;
            (2) to prevent the need for United States and international 
        military intervention abroad through the utilization of 
        diplomacy to resolve issues of concern to the United States and 
        the international community; and
            (3) that no funds appropriated or otherwise made available 
        to any executive agency of the United States Government may be 
        used to carry out any North Atlantic Treaty Organization 
        military operation or deploy a unit or individual of the United 
        States Armed Forces or an element of the intelligence community 
        in support of a NATO military operation unless the President 
        determines that such military operation is warranted and seeks 
        express prior authorization by Congress, as required under 
        article I, section 8 of the Constitution, except that this 
        requirement shall not apply to a military operation--
                    (A) to directly repel an offensive military action 
                launched against the United States or an ally with whom 
                the United States has a mutual defense assistance 
                agreement; or
                    (B) to directly thwart an imminent offensive 
                military action to be launched against the United 
                States or an ally with whom the United States has a 
                mutual defense assistance agreement.

SEC. 3. PROHIBITION ON DEPLOYMENT OF UNITED STATES ARMED FORCES OR 
              ELEMENT OF THE INTELLIGENCE COMMUNITY.

    (a) Prohibition on Deployment.--Except as provided in subsection 
(b), no unit or individual of the United States Armed Forces or an 
element of the intelligence community may be deployed in support of a 
North Atlantic Treaty Organization military operation absent express 
prior statutory authorization from Congress for such deployment.
    (b) Exception.--Subsection (a) shall not apply to a military 
operation--
            (1) to directly repel an offensive military action launched 
        against the United States or an ally with whom the United 
        States has a mutual defense assistance agreement; or
            (2) to directly thwart an imminent offensive military 
        action to be launched against the United States or an ally with 
        whom the United States has a mutual defense assistance 
        agreement.
    (c) Definitions.--In this section--
            (1) the term ``deployment'' has the meaning given that term 
        in section 991(b) of title 10, United States Code; and
            (2) the term ``intelligence community'' has the meaning 
        given the term in section 3(4) of the National Security Act of 
        1947 (50 U.S.C. 401a(4)).
    (d) Effective Date.--This section takes effect on the date of the 
enactment of this Act and applies with respect to North Atlantic Treaty 
Organization military operations initiated on or after such date of 
enactment.

SOLUTION:
States that it is the policy of the United States: (1) to protect the role of Congress as a coequal branch of government and ensure protection of its constitutional authority to declare war and support the Armed Forces; (2) to prevent the need for U.S. and international military intervention abroad through the utilization of diplomacy to resolve issues of concern to the United States and the international community; and (3) that no federal funds may be used to carry out any North Atlantic Treaty Organization (NATO) military operation or to deploy a unit of individual of the U.S. Armed Forces or an element of the intelligence community (IC) in support of a NATO military operation unless the President determines that such operation is warranted and seeks express prior authorization by Congress, as required under the Constitution. Provides an exception in the case of a military operation to directly thwart or repel an offensive military action launched against the United States or an ally with whom the United States has a mutual defense assistance agreement.

Prohibits any unit or individual of the U.S. Armed Forces or IC element from being deployed in support of a NATO military operation absent express prior statutory authorization from Congress, unless under the exception described above.