In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.

Input: Consider Input: 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.'.''.

Output: 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.


Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Year 2000 Act''.

SEC. 2. FINDINGS.

    The Congress makes the following findings:
            (1) Electronic data exchanges are used extensively to 
        transfer information between computer systems. Federal agencies 
        now depend on electronic data exchanges to execute programs and 
        facilitate commerce. Consequently, as computer systems are 
        converted to process Year 2000 dates, the associated data 
        exchanges must also be made Year 2000 compliant.
            (2) The testing and implementation of new data exchanges 
        must be closely coordinated with exchange partners to be 
        completed effectively. If Year 2000 data exchanges do not 
        function properly, data will not be exchanged between systems, 
        or invalid data could cause receiving computer systems to 
        malfunction or produce inaccurate computations.
            (3) The United States 381,000 small manufacturers 
        contribute more than half of the country's total value in 
        manufacturing. However, as of 1997, 88 percent of all companies 
        with fewer than 2,000 employees had not yet started Year 2000 
        remediation projects.
            (4) As small manufacturers are an integral part of the 
        business supply chain, it is imperative that their computer 
        systems are Year 2000 compliant to prevent disruption to the 
        country's manufacturing base.
            (5) The economic well being of the United States is 
        interdependent with the economic well being of other nations of 
        the world. There is very little information on the level of 
        Year 2000 preparedness by other countries and the potential 
        impact on the United States economy. Therefore, to prevent 
        economic disruption in the United States, the Year 2000 
        computer problem must be addressed on a global scale.
            (6) Consumer awareness of the potential and extent of 
        failure of computer hardware, software, and embedded microchips 
        found in many consumer products resulting from the Year 2000 
        problem is small.
            (7) Currently, there is no information to guide consumers 
        in the purchase of Year 2000 compliant consumer goods or to 
        ensure that their existing goods are Year 2000 complaint.

SEC. 3. DEFINITIONS.

    For purposes of this Act--
            (1) the term ``end-to-end testing'' means testing data 
        exchange software with respect to--
                    (A) the initiation of the exchange by sending 
                computers;
                    (B) transmission through intermediate 
                communications software and hardware; and
                    (C) receipt and acceptance by receiving computers;
            (2) the term ``small and medium-sized businesses'' means 
        businesses with less than 500 employees;
            (3) the term ``Year 2000 compliant'' means, with respect to 
        information technology, that the information technology 
        accurately processes (including calculating, comparing, and 
        sequencing) date and time data from, into, and between the 20th 
        and 21st centuries and the years 1999 and 2000, and leap year 
        calculations, to the extent that other information technology 
        properly exchanges date and time data with it; and
            (4) the term ``Year 2000 computer problem'' means the 
        potential problems that might be encountered in any level of 
        computer hardware and software from microcode to application 
        programs, files, and databases that need to correctly interpret 
        year date data represented in 2-digit-year format.

SEC. 4. FEDERAL AGENCY ACTIONS.

    To ensure that all computer operations and processing can be 
provided without interruption by Federal agencies after December 31, 
1999, the head of each Federal agency shall--
            (1) take actions necessary to ensure that all systems and 
        hardware administered by the agency are Year 2000 compliant, to 
        the extent necessary to ensure that no significant disruption 
        of the operations of the agency or of the agency's data 
        exchange partners occurs, including--
                    (A) establishing, before March 1, 1999, schedules 
                for testing and implementing new data exchange formats 
                for completing all data exchange corrections, which may 
                include national test days for end-to-end testing of 
                critical processes and associated data exchanges 
                affecting Federal, State, and local governments;
                    (B) notifying data exchange partners of the 
                implications to the agency and the exchange partners if 
                they do not make appropriate date conversion 
                corrections in time to meet the Federal schedule for 
                implementing and testing Year 2000 compliant data 
                exchange processes;
                    (C) giving priority to installing filters necessary 
                to prevent the corruption of mission-critical systems 
                from data exchanges with noncompliant systems; and
                    (D) developing and implementing, as part of the 
                agency's continuity and contingency planning efforts, 
                specific provisions for data exchanges that may fail, 
                including strategies to mitigate operational 
                disruptions if data exchange partners do not make 
                timely date conversion corrections;
            (2) beginning not later than 30 days after the date of the 
        enactment of this Act, convene meetings at least quarterly with 
        representatives of the agency's data exchange partners to 
        assess implementation progress; and
            (3) after each meeting convened pursuant to paragraph (2), 
        transmit to the Congress a report summarizing--
                    (A) the results of that meeting; and
                    (B) the status of the agency's completion of key 
                data exchange corrections, including the extent of data 
                exchange inventoried, an assessment of data exchange 
                formats agreed to with data exchange partners, testing 
                and implementation schedules, and testing and 
                implementation completed.

SEC. 5. ASSISTANCE FOR SMALL AND MEDIUM-SIZED BUSINESSES.

    To ensure that the Nation's small and medium-sized businesses are 
prepared to meet the Year 2000 computer problem challenge, the National 
Institute of Standards and Technology, in conjunction with the Small 
Business Administration, shall develop a Year 2000 compliance outreach 
program to assist small and medium-sized businesses. Such program shall 
include--
            (1) the development of a Year 2000 self-assessment 
        checklist;
            (2) an explanation of the Year 2000 computer problem and an 
        identification of best practices for resolving the problem;
            (3) a list of Federal Government Year 2000 information 
        resources; and
            (4) a list of Year 2000 compliant products provided by the 
        General Services Administration.

SEC. 6. INTERNATIONAL ASSESSMENT.

    Within 6 months after the date of the enactment of this Act, the 
Under Secretary of Commerce for Technology, in conjunction with other 
relevant Federal agencies, shall transmit to the Congress a report 
assessing the international implications of the Year 2000 computer 
problem. Such report shall include--
            (1) an assessment of Year 2000 compliance by the United 
        States major trading partners;
            (2) a description of efforts by the United States to share 
        best practices with other countries;
            (3) the economic implications on world trade and the United 
        States economy of the Year 2000 computer problem, including an 
        identification of impacted United States industrial sectors and 
        Federal agencies; and
            (4) a summary of participation by Federal agencies in 
        international fora addressing the Year 2000 computer problem.

SEC. 7. CONSUMER AWARENESS.

    To ensure that the Nation's consumers are aware of and prepared to 
meet the Year 2000 computer problem challenge, the Under Secretary of 
Commerce for Technology shall develop a Year 2000 consumer awareness 
program to assist the public in becoming aware of the implications of 
the Year 2000 computer problem. Such program shall include--
            (1) the development of a Year 2000 self-assessment 
        checklist;
            (2) a list of Federal Government Year 2000 computer problem 
        information resources;
            (3) a list of Year 2000 compliant products provided by the 
        General Services Administration;
            (4) a series of public awareness announcements or seminars 
        on the impact of the Year 2000 computer problem on consumer 
        products and services; and
            (5) a series of public awareness announcements or seminars 
        on the potential effect that the Year 2000 computer problem 
        could have on the provision of services by the Federal 
        Government to the public, and the progress made in resolving 
        the problem by the Federal agencies providing those services.

Output: Year 2000 Act - Requires the head of each Federal agency to:  (1) take actions necessary to ensure that all systems and hardware administered by the agency are Year 2000 compliant to the extent necessary to ensure that no significant disruption of the agency's operations or data exchange partners occurs; and (2) convene, at least quarterly, and report to the Congress on, meetings with representatives of the agency's data exchange partners to assess implementation progress. 
Directs the National Institute of Standards and Technology, in conjunction with the Small Business Administration, to develop a Year 2000 compliance outreach program to assist the Nation's small and medium-sized businesses to ensure that such businesses are prepared to meet the Year 2000 computer problem (Y2K problem) challenge. 
Requires the Under Secretary of Commerce for Technology:  (1) in conjunction with other relevant Federal agencies, to transmit to the Congress a report assessing the international implications of the Year 2000 computer problem; and (2) to develop a Year 2000 consumer awareness program to assist the public in becoming aware of the implications of such problem.


Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Regulatory Transparency, Patient 
Access, and Effective Drug Enforcement Act of 2014''.

SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW FDA-APPROVED DRUGS.

    Section 201 of the Controlled Substances Act (21 U.S.C. 811) is 
amended by inserting after subsection (h) the following:
    ``(i) Within 45 days of receiving a recommendation from the 
Secretary to add a drug or substance that has never been marketed in 
the United States to a schedule under this title, the Attorney General 
shall, without regard to the findings required by subsection (a) of 
this section or section 202(b), issue an interim final rule, under the 
exception for good cause described in subparagraph (B) of section 
553(b) of title 5, United States Code, placing the drug or substance 
into the schedule recommended by the Secretary. The interim final rule 
shall be made immediately effective under section 553(d)(3) of title 5, 
United States Code.''.

SEC. 3. ENHANCING NEW DRUG DEVELOPMENT.

    Section 302 of the Controlled Substances Act (21 U.S.C. 822) is 
amended by inserting after subsection (g) the following:
    ``(h)(1) A person who submits an application for registration to 
manufacture or distribute a controlled substance in accordance with 
this section may indicate on the registration application that the 
substance will be used only in connection with clinical trials of a 
drug in accordance with section 505(i) of the Federal Food, Drug, and 
Cosmetic Act.
    ``(2) When an application for registration to manufacture or 
distribute a controlled substance includes an indication that the 
controlled substance will be used only in connection with clinical 
trials of a drug in accordance with section 505(i) of the Federal Food, 
Drug, and Cosmetic Act, the Attorney General shall--
            ``(A) make a final decision on the application for 
        registration within 180 days; or
            ``(B) provide notice to the applicant in writing of--
                    ``(i) the outstanding issues that must be resolved 
                in order to reach a final decision on the application; 
                and
                    ``(ii) the estimated date on which a final decision 
                on the application will be made.''.

SEC. 4. REGISTRATION PROCESS UNDER CONTROLLED SUBSTANCES ACT.

    (a) Definitions.--
            (1) Factors as may be relevant to and consistent with the 
        public health and safety.--Section 303 of the Controlled 
        Substances Act (21 U.S.C. 823) is amended by adding at the end 
        the following:
    ``(i) In this section, the phrase `factors as may be relevant to 
and consistent with the public health and safety' means factors that 
are relevant to and consistent with the findings contained in section 
101.''.
            (2) Imminent danger to the public health or safety.--
        Section 304(d) of the Controlled Substances Act (21 U.S.C. 
        824(d)) is amended--
                    (A) by striking ``(d) The Attorney General'' and 
                inserting ``(d)(1) The Attorney General''; and
                    (B) by adding at the end the following:
    ``(2) In this subsection, the phrase `imminent danger to the public 
health or safety' means that, in the absence of an immediate suspension 
order, controlled substances will continue to be distributed or 
dispensed by a registrant who knows or should know through fulfilling 
the obligations of the registrant under this Act, or has reason to 
believe that--
            ``(A) the dispensing is outside the usual course of 
        professional practice;
            ``(B) the distribution or dispensing poses a present or 
        foreseeable risk of adverse health consequences or death due to 
        the abuse or misuse of the controlled substances; or
            ``(C) the controlled substances will continue to be 
        diverted outside of legitimate distribution channels.''.
    (b) Opportunity To Submit Corrective Action Plan Prior to 
Revocation or Suspension.--Subsection (c) of section 304 of the 
Controlled Substances Act (21 U.S.C. 824) is amended--
            (1) by striking the last two sentences;
            (2) by striking ``(c) Before'' and inserting ``(c)(1) 
        Before''; and
            (3) by adding at the end the following:
    ``(2) An order to show cause under paragraph (1) shall--
            ``(A) contain a statement of the basis for the denial, 
        revocation, or suspension, including specific citations to any 
        laws or regulations alleged to be violated by the applicant or 
        registrant;
            ``(B) direct the applicant or registrant to appear before 
        the Attorney General at a time and place stated in the order, 
        but not less than 30 days after the date of receipt of the 
        order; and
            ``(C) notify the applicant or registrant of the opportunity 
        to submit a corrective action plan on or before the date of 
        appearance.
    ``(3) Upon review of any corrective action plan submitted by an 
applicant or registrant pursuant to paragraph (2), the Attorney General 
shall determine whether denial, revocation or suspension proceedings 
should be discontinued, or deferred for the purposes of modification, 
amendment, or clarification to such plan.
    ``(4) Proceedings to deny, revoke, or suspend shall be conducted 
pursuant to this section in accordance with subchapter II of chapter 5 
of title 5, United States Code. Such proceedings shall be independent 
of, and not in lieu of, criminal prosecutions or other proceedings 
under this title or any other law of the United States.
    ``(5) The requirements of this subsection shall not apply to the 
issuance of an immediate suspension order under subsection (d).''.

SEC. 5. REPORT TO CONGRESS ON EFFECTS OF LAW ENFORCEMENT ACTIVITIES ON 
              PATIENT ACCESS TO MEDICATIONS.

    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs and the Director of the Centers for 
Disease Control and Prevention, and in consultation with the 
Administrator of the Drug Enforcement Administration and the Director 
of National Drug Control Policy, shall submit a report to the 
Committees on the Judiciary of the House of Representatives, the 
Committee on Energy and Commerce of the House of Representatives, the 
Committee on the Judiciary of the Senate, and the Committee on Health, 
Education, Labor and Pensions of the Senate identifying--
            (1) obstacles to legitimate patient access to controlled 
        substances;
            (2) issues with diversion of controlled substances; and
            (3) how collaboration between Federal, State, local, and 
        tribal law enforcement agencies and the pharmaceutical industry 
        can benefit patients and prevent diversion and abuse of 
        controlled substances.
    (b) Consultation.--The report under subsection (a) shall 
incorporate feedback and recommendations from the following:
            (1) Patient groups.
            (2) Pharmacies.
            (3) Drug manufacturers.
            (4) Common or contract carriers and warehousemen.
            (5) Hospitals, physicians, and other health care providers.
            (6) State attorneys general.
            (7) Federal, State, local, and tribal law enforcement 
        agencies.
            (8) Health insurance providers and entities that provide 
        pharmacy benefit management services on behalf of a health 
        insurance provider.
            (9) Wholesale drug distributors.


Output: Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 - Amends the Controlled Substances Act to direct the Attorney General, within 45 days of receiving a recommendation from the Secretary of Health and Human Services (HHS) to add a drug or substance that has never been marketed in the United States to a schedule of controlled substances, to issue an interim final rule under the exception for good cause, placing it into the schedule recommended, effective immediately. Allows a person who submits an application for registration to manufacture or distribute a controlled substance to indicate on the registration application that the substance will be used only in connection with clinical trials of a drug. Requires the Attorney General to: (1) make a final decision on such application within 180 days, or (2) provide written notice to the applicant of the outstanding issues that must be resolved to reach a final decision and the estimated date on which such decision will be made. Defines: (1) "factors as may be relevant to and consistent with the public health and safety," and (2) "imminent danger to the public health or safety." Requires an order to show cause as to why a registration should not be denied, revoked, or suspended to notify the registrant of the opportunity to submit a corrective action plan on or before the date of appearance before the Attorney General. Requires the Attorney General, upon review of any such plan, to determine whether denial, revocation, or suspension proceedings should be discontinued or deferred for purposes of modification or clarification of such plan. Makes these requirements inapplicable to the issuance of an immediate suspension order. Directs the Secretary, acting through the Commissioner of Food and Drugs (FDA) and the Director of the Centers for Disease Control and Prevention (CDC), to identify: (1) obstacles to legitimate patient access to controlled substances; (2) issues with diversion of controlled substances; and (3) how collaboration between federal, state, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances.