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

Example Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Fuel Efficiency Energy Act of 
2007''.

SEC. 2. DEFINITIONS.

    (a) Automobile.--Section 32901(a)(3) of title 49, United States 
Code, is amended--
            (1) by striking ``4-wheeled''; and
            (2) by striking ``, and rated at--'' and all that follows 
        and inserting a period.
    (b) Medium-Duty Truck.--Section 32901(a) of such title is amended--
            (1) by redesignating paragraphs (14), (15), and (16) as 
        paragraphs (15), (16), and (17), respectively; and
            (2) by inserting after paragraph (13) the following:
            ``(14) `medium-duty truck' means a truck (as defined in 
        section 30127) with a gross vehicle weight between 10,000 and 
        26,000 pounds.''.
    (c) Passenger Automobile.--Section 32901(a)(17) of such title, as 
redesignated by subsection (b)(1), is amended by striking ``decides by 
regulation--'' and all that follows through the period and inserting 
``determines by regulation, to have a significant feature (except 4-
wheel drive) designed for off-highway operation.''.
    (d) Fuel Economy Information.--Section 32908(a) of such title is 
amended--
            (1) in the subsection heading, by striking ``Definitions'' 
        and inserting ``Definition''; and
            (2) by striking ``section--'' and all that follows through 
        ``(2)'' and inserting ``section, the term''.

SEC. 3. ANNUAL INCREASE IN AVERAGE FUEL ECONOMY STANDARDS.

    (a) Fuel Efficiency Standards.--
            (1) In general.--Section 32902 of title 49, United States 
        Code, is amended by striking subsections (a) through (c) and 
        inserting the following:
    ``(a) In General.--Not later than 18 months before the beginning of 
each model year beginning with model year 2012, the Secretary of 
Transportation, shall prescribe, by regulation, average fuel economy 
standards for automobiles manufactured by a manufacturer for that model 
year in accordance with subsection (b). The Secretary of Transportation 
shall prescribe separate average fuel economy standards for different 
classes of automobiles. The Secretary shall establish average fuel 
economy standards for medium-duty trucks that are consistent with the 
projected benefits of hybridization.
    ``(b) Annual Increases in Fuel Economy Standards.--
            ``(1) For model year 2012.--For model year 2012, the 
        average fuel economy standard for each class of automobiles 
        shall be the average combined highway and city miles per gallon 
        performance of all automobiles within that class of automobiles 
        in 2011 (rounded to the nearest \1/10\ mile per gallon).
            ``(2) For model years after model year 2012.--For each 
        model year beginning with model year 2013 and ending with model 
        year 2030, the average fuel economy attained by the fleet of 
        automobiles manufactured or sold in the United States shall be 
        at least 4 percent greater than the average fuel economy 
        standard for the fleet in the previous model year (rounded to 
        the nearest \1/10\ mile per gallon).
    ``(c) Amending Fuel Economy Standards.--
            ``(1) In general.--Notwithstanding subsections (a) and (b), 
        the Secretary of Transportation may prescribe an average fuel 
        economy standard for a class of automobiles in a model year 
        that is lower than the standard required under subsection (b) 
        if the Secretary of Transportation, in consultation with the 
        National Academy of Sciences, determines that the average fuel 
        economy standard prescribed in accordance with subsections (a) 
        and (b) for that class of automobiles in that model year--
                    ``(A) is not technologically achievable;
                    ``(B) cannot be achieved without materially 
                reducing the overall safety of automobiles manufactured 
                or sold in the United States and no offsetting safety 
                improvements can be practicably implemented for that 
                model year; or
                    ``(C) is shown not to be cost effective.
            ``(2) Maximum standard.--Any average fuel economy standard 
        prescribed for a class of automobiles in a model year under 
        paragraph (1) shall be the maximum standard that--
                    ``(A) is technologically achievable;
                    ``(B) can be achieved without materially reducing 
                the overall safety of automobiles manufactured or sold 
                in the United States; and
                    ``(C) is cost effective.
            ``(3) Considerations in determination of cost 
        effectiveness.--In determining cost effectiveness under 
        paragraph (1)(C), the Secretary of Transportation shall take 
        into account the total value to the United States of reduced 
        petroleum use, including the value of reducing external costs 
        of petroleum use, using a value for such costs equal to 50 
        percent of the value of 1 gallon of gasoline saved or the 
        amount determined in an analysis of the external costs of 
        petroleum use that considers--
                    ``(A) value to consumers;
                    ``(B) economic security;
                    ``(C) national security;
                    ``(D) foreign policy;
                    ``(E) the impact of oil use--
                            ``(i) on sustained cartel rents paid to 
                        foreign suppliers;
                            ``(ii) on long-run potential gross domestic 
                        product due to higher normal-market oil price 
                        levels, including inflationary impacts;
                            ``(iii) on import costs, wealth transfers, 
                        and potential gross domestic product due to 
                        increased trade imbalances;
                            ``(iv) on import costs and wealth transfers 
                        during oil shocks;
                            ``(v) on macroeconomic dislocation and 
                        adjustment costs during oil shocks;
                            ``(vi) on the cost of existing energy 
                        security policies, including the management of 
                        the Strategic Petroleum Reserve;
                            ``(vii) on the timing and severity of the 
                        oil peaking problem;
                            ``(viii) on the risk, probability, size, 
                        and duration of oil supply disruptions;
                            ``(ix) on the strategic behavior of the 
                        Organization of the Petroleum Exporting 
                        Countries and long-run oil pricing;
                            ``(x) on the short term elasticity of 
                        energy demand and the magnitude of price 
                        increases resulting from a supply shock;
                            ``(xi) on oil imports, military costs, and 
                        related security costs, including intelligence, 
                        homeland security, sea lane security and 
                        infrastructure, and other military activities;
                            ``(xii) on oil imports, diplomatic and 
                        foreign policy flexibility, and connections to 
                        geopolitical strife, terrorism, and 
                        international development activities;
                            ``(xiii) all relevant environmental hazards 
                        under the jurisdiction of the Environmental 
                        Protection Agency; and
                            ``(xiv) on well-to-wheels urban and local 
                        air emissions of pollutants and their 
                        uninternalized costs;
                    ``(F) the impact of the oil or energy intensity of 
                the United States economy on the sensitivity of the 
                economy to oil price changes, including the magnitude 
                of gross domestic product losses in response to short 
                term price shocks or long term price increases;
                    ``(G) the impact of United States payments for oil 
                imports on political, economic, and military 
                developments in unstable or unfriendly oil-exporting 
                countries;
                    ``(H) the uninternalized costs of pipeline and 
                storage oil seepage, and for risk of oil spills from 
                production, handling, and transport, and related 
                landscape damage; and
                    ``(I) additional relevant factors, as determined by 
                the Secretary.
            ``(4) Minimum valuation.--When considering the value to 
        consumers of a gallon of gasoline saved, the Secretary of 
        Transportation may not use a value less than the greatest of--
                    ``(A) the average national cost of a gallon of 
                gasoline sold in the United States during the 12-month 
                period ending on the date on which the new fuel economy 
                standard is proposed;
                    ``(B) the most recent weekly estimate by the Energy 
                Information Administration of the Department of Energy 
                of the average national cost of a gallon of gasoline 
                (all grades) sold in the United States; and
                    ``(C) the gasoline prices projected by the Energy 
                Information Administration for the 20-year period 
                beginning in the year following the year in which the 
                standards are established.''.
            (2) Conforming amendments.--Title 49, United States Code, 
        is amended--
                    (A) in section 32902--
                            (i) in subsection (d) by striking 
                        ``subsection (b) or (c) of this section'' and 
                        inserting ``subsection (a), (b), or (c)'';
                            (ii) by striking subsection (f);
                            (iii) in subsection (g)--
                                    (I) by striking ``subsection (a) or 
                                (d)'' and inserting ``this section''; 
                                and
                                    (II) by striking ``(and submit the 
                                amendment to Congress when required 
                                under subsection (c)(2) of this 
                                section)''; and
                            (iv) in subsection (h) by striking 
                        ``subsections (c), (f), and (g) of this 
                        section'' and inserting ``subsections (c) and 
                        (g)'';
                    (B) in section 32903--
                            (i) by striking ``section 32902(b)-(d) of 
                        this title'' each place it occurs and inserting 
                        ``subsections (a) through (d) of section 
                        32902''; and
                            (ii) in subsection (e), by striking 
                        ``section 32902(a) of this title'' and 
                        inserting ``subsections (a) through (d) of 
                        section 32902''; and
                    (C) in section 32904--
                            (i) in subsection (a)--
                                    (I) by striking ``subject to--'' 
                                and all that follows through ``(B) 
                                section 32902(a)-(d) of this title'' 
                                and inserting ``subject to subsections 
                                (a) through (d) of section 32902''; and
                                    (II) by redesignating clauses (i) 
                                and (ii) as subparagraphs (A) and (B), 
                                respectively.
    (b) Repeal of Credit for Dual Fueled Automobiles.--
            (1) In general.--Section 32905 of title 49, United States 
        Code, is amended--
                    (A) by amending subsection (b) to read as follows:
    ``(b) Dual Fueled Automobiles.--The Administrator of the 
Environmental Protection Agency shall measure the fuel economy for any 
model of dual fueled automobile manufactured in model year 2012 and any 
model year thereafter, in accordance with section 32904.''; and
                    (B) by amending subsection (d) to read as follows:
    ``(d) Gaseous Fuel Dual Fueled Automobiles.--The Administrator of 
the Environmental Protection Agency shall measure the fuel economy for 
any model of gaseous fuel dual fueled automobile manufactured in model 
year 2012 and any model year thereafter, in accordance with section 
32904.''.
            (2) Conforming amendments.--Section 32905 of such title is 
        further amended--
                    (A) by striking subsection (f); and
                    (B) redesignating subsections (g) and (h) as 
                subsections (f) and (g), respectively.

SEC. 4. REQUIREMENT TO INCREASE PERCENTAGE OF DUAL FUELED AUTOMOBILES.

    Section 32902 of title 49, United States Code, as amended by 
section 3, is further amended by inserting after subsection (e) the 
following:
    ``(f) Requirement for Annual Increase in Duel Fueled Automobiles.--
Each manufacturer shall ensure that the percentage of automobiles 
manufactured by such manufacturer in each of model years 2012 through 
2022 that are dual fueled automobiles is not less than 10 percent 
greater than the percentage of automobiles manufactured by such 
manufacturer in the previous model year that are dual fueled 
automobiles.''.

SEC. 5. EFFECTIVE DATE.

    The amendments made by this Act shall--
            (1) take effect on January 1, 2010; and
            (2) apply to automobiles manufactured for model year 2012 
        and for each subsequent model year.
Example Output: Fuel Efficiency Energy Act of 2007 - Amends corporate average fuel economy (CAFE) provisions to revise the definition of: (1) "automobile" to mean any vehicle that is propelled by fuel, or by alternative fuel, and is manufactured primarily for use on public streets, roads, and highways (currently, four-wheeled vehicles that are so propelled and manufactured for such use and that are up to 6,000 pounds and certain vehicles between 6,000 and 10,000 pounds); and (2) "passenger automobile" to eliminate the exception for 4-wheel drive automobiles and vehicles weighing more than 6,000 pounds. Defines "medium-duty truck" as a truck with a gross vehicle weight between 10,000 and 26,000 pounds.

Requires the Secretary of Transportation to: (1) prescribe separate increased minimum CAFE standards for different classes of automobiles manufactured beginning for model year 2012, but adds an increase of 4% per year in such standard for model years 2013 through 2030; and (2) establish CAFE standards for medium-duty trucks that are consistent with hybridization beginning for model year 2012.

Revises the calculation of fuel economy standards for dual fueled automobiles and gaseous fuel dual fueled automobiles manufactured in model year 2012 and beyond to require using the same calculation provisions as used for gas or diesel fueled vehicles. Repeals provisions allowing the Department of Transportation (DOT) to extend manufacturing credits for such automobiles.

Example Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Drug Competition Act of 2002''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) prescription drug prices are increasing at an alarming 
        rate and are a major worry of many senior citizens and American 
        families;
            (2) there is a potential for companies with patent rights 
        regarding brand name drugs and companies which could 
        manufacture generic versions of such drugs to enter into 
        financial deals that could tend to restrain trade and greatly 
        reduce competition and increase prescription drug expenditures 
        for American citizens; and
            (3) enhancing competition among these companies can 
        significantly reduce prescription drug expenditures for 
        Americans.

SEC. 3. PURPOSES.

    The purposes of this Act are--
            (1) to provide timely notice to the Department of Justice 
        and the Federal Trade Commission regarding agreements between 
        companies with patent rights regarding brand name drugs and 
        companies which could manufacture generic versions of such 
        drugs; and
            (2) by providing timely notice, to enhance the 
        effectiveness and efficiency of the enforcement of the 
        antitrust and competition laws of the United States.

SEC. 4. DEFINITIONS.

    In this Act:
            (1) ANDA.--The term ``ANDA'' means an Abbreviated New Drug 
        Application, as defined under section 201(aa) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 321(aa)).
            (2) Assistant attorney general.--The term ``Assistant 
        Attorney General'' means the Assistant Attorney General in 
        charge of the Antitrust Division of the Department of Justice.
            (3) Brand name drug.--The term ``brand name drug'' means a 
        drug approved under section 505(c) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355(c)).
            (4) Brand name drug company.--The term ``brand name drug 
        company'' means the party that received Food and Drug 
        Administration approval to market a brand name drug pursuant to 
        an NDA, where that drug is the subject of an ANDA, or a party 
        owning or controlling enforcement of any patent listed in the 
        Approved Drug Products With Therapeutic Equivalence Evaluations 
        of the Food and Drug Administration for that drug, under 
        section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(b)).
            (5) Commission.--The term ``Commission'' means the Federal 
        Trade Commission.
            (6) Generic drug.--The term ``generic drug'' means a 
        product that the Food and Drug Administration has approved 
        under section 505(j) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355(j)).
            (7) Generic drug applicant.--The term ``generic drug 
        applicant'' means a person who has filed or received approval 
        for an ANDA under section 505(j) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355(j)).
            (8) NDA.--The term ``NDA'' means a New Drug Application, as 
        defined under section 505(b) et seq. of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355(b) et seq.)

SEC. 5. NOTIFICATION OF AGREEMENTS.

    (a) In General.--
            (1) Requirement.--A generic drug applicant that has 
        submitted an ANDA containing a certification under section 
        505(j)(2)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355(j)(2)(vii)(IV)) and a brand name drug company 
        that enter into an agreement described in paragraph (2), prior 
        to the generic drug that is the subject of the application 
        entering the market, shall each file the agreement as required 
        by subsection (b).
            (2) Definition.--An agreement described in this paragraph 
        is an agreement regarding--
                    (A) the manufacture, marketing or sale of the brand 
                name drug that is the subject of the generic drug 
                applicant's ANDA;
                    (B) the manufacture, marketing or sale of the 
                generic drug that is the subject of the generic drug 
                applicant's ANDA; or
                    (C) the 180-day period referred to in section 
                505(j)(5)(B)(iv) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) as it applies 
                to such ANDA or to any other ANDA based on the same 
                brand name drug.
    (b) Filing.--
            (1) Agreement.--The generic drug applicant and the brand 
        name drug company entering into an agreement described in 
        subsection (a)(2) shall file with the Assistant Attorney 
        General and the Commission the text of any such agreement, 
        except that the generic drug applicant and the brand-name drug 
        company shall not be required to file an agreement that solely 
        concerns--
                    (A) purchase orders for raw material supplies;
                    (B) equipment and facility contracts;
                    (C) employment or consulting contracts; or
                    (D) packaging and labeling contracts.
            (2) Other agreements.--The generic drug applicant and the 
        brand name drug company entering into an agreement described in 
        subsection (a)(2) shall file with the Assistant Attorney 
        General and the Commission the text of any other agreements not 
        described in subsection (a)(2) between the generic drug 
        applicant and the brand name drug company which are contingent 
        upon, provide a contingent condition for, or are otherwise 
        related to an agreement which must be filed under this Act.
            (3) Description.--In the event that any agreement required 
        to be filed by paragraph (1) or (2) has not been reduced to 
        text, both the generic drug applicant and the brand name drug 
        company shall file written descriptions of the non-textual 
        agreement or agreements that must be filed sufficient to reveal 
        all of the terms of the agreement or agreements.

SEC. 6. FILING DEADLINES.

    Any filing required under section 5 shall be filed with the 
Assistant Attorney General and the Commission not later than 10 
business days after the date the agreements are executed.

SEC. 7. DISCLOSURE EXEMPTION.

    Any information or documentary material filed with the Assistant 
Attorney General or the Commission pursuant to this Act shall be exempt 
from disclosure under section 552 of title 5, and no such information 
or documentary material may be made public, except as may be relevant 
to any administrative or judicial action or proceeding. Nothing in this 
section is intended to prevent disclosure to either body of Congress or 
to any duly authorized committee or subcommittee of the Congress.

SEC. 8. ENFORCEMENT.

    (a) Civil Penalty.--Any brand name drug company or generic drug 
applicant which fails to comply with any provision of this Act shall be 
liable for a civil penalty of not more than $11,000, for each day 
during which such entity is in violation of this Act. Such penalty may 
be recovered in a civil action brought by the United States, or brought 
by the Commission in accordance with the procedures established in 
section 16(a)(1) of the Federal Trade Commission Act (15 U.S.C. 56(a)).
    (b) Compliance and Equitable Relief.--If any brand name drug 
company or generic drug applicant fails to comply with any provision of 
this Act, the United States district court may order compliance, and 
may grant such other equitable relief as the court in its discretion 
determines necessary or appropriate, upon application of the Assistant 
Attorney General or the Commission.

SEC. 9. RULEMAKING.

    The Commission, with the concurrence of the Assistant Attorney 
General and by rule in accordance with section 553 of title 5 United 
States Code, consistent with the purposes of this Act--
            (1) may define the terms used in this Act;
            (2) may exempt classes of persons or agreements from the 
        requirements of this Act; and
            (3) may prescribe such other rules as may be necessary and 
        appropriate to carry out the purposes of this Act.

SEC. 10. SAVINGS CLAUSE.

    Any action taken by the Assistant Attorney General or the 
Commission, or any failure of the Assistant Attorney General or the 
Commission to take action, under this Act shall not bar any proceeding 
or any action with respect to any agreement between a brand name drug 
company and a generic drug applicant at any time under any other 
provision of law, nor shall any filing under this Act constitute or 
create a presumption of any violation of any antitrust or competition 
laws.

SEC. 11. EFFECTIVE DATE.

    This Act shall--
            (1) take effect 30 days after the date of enactment of this 
        Act; and
            (2) shall apply to agreements described in section 5 that 
        are entered into 30 days after the date of enactment of this 
        Act.

            Passed the Senate November 18, 2002.

            Attest:

                                                  JERI THOMSON,

                                                             Secretary.
Example Output: Drug Competition Act of 2002 - (Sec. 5) Requires a generic drug applicant that has submitted an Abbreviated New Drug Application (ANDA) and a brand name drug company that enter into an agreement, prior to the generic drug entering the market, regarding the manufacture, marketing, or sale of the brand name or the generic drug, or regarding the 180-day semi-exclusivity period referred to in the Federal Food, Drug, and Cosmetic Act as it applies to such ANDA or any other ANDA based on the same brand name drug, to each file such agreement and any related agreements with the Assistant Attorney General and the Federal Trade Commission (FTC). Makes an exception for agreements that solely concern purchase orders for raw material supplies, equipment and facility contracts, or employment or consulting contracts. Requires such agreements to be filed not later than ten business days after the date they are executed.(Sec. 7) Exempts any such information or documentary material filed from disclosure under the Freedom of Information Act. Prohibits such information or material from being made public, except as relevant to any administrative or judicial action or proceeding.(Sec. 8) Subjects an applicant or company to a civil penalty of up to $11,000 for each day such entity fails to comply with this Act, recoverable in a civil action brought by the United States or the FTC. Authorizes a U.S. district court to order compliance and grant equitable relief.

Example Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Federal Research Informed Consent 
Act''.

SEC. 2. REQUIREMENT OF INFORMED CONSENT REGARDING USE OF HUMAN SUBJECTS 
              IN FEDERALLY QUALIFIED RESEARCH.

    (a) In General.--Section 491 of the Public Health Service Act (42 
U.S.C. 289) is amended by adding at the end the following subsection:
    ``(c) Requirement of Informed Consent Regarding Human Subjects.--
            ``(1) In general.--Subject to paragraph (2), the Secretary 
        shall by regulation establish the requirement that, in 
        federally qualified research in which any human subject is to 
        be used, an individual may not be used as a subject unless the 
        principal researcher obtains the informed consent of the 
        individual to serve as a subject.
            ``(2) Exempted categories of research.--
                    ``(A) With respect to the requirement of paragraph 
                (1) that informed consent be obtained, the Secretary 
                may, in issuing regulations under such paragraph, 
                establish such exempted categories of research as the 
                Secretary determines to be appropriate. The regulations 
                may not authorize any waiver of the applicability of 
                the requirement to a research activity that is not 
                within such a category.
                    ``(B) In the case of a particular research 
                activity, the Secretary is responsible for approving or 
                disapproving the activity as qualifying for an 
                exemption under subparagraph (A).
                    ``(C) If under subparagraph (B) the Secretary 
                approves an exemption, the Secretary shall submit to 
                the congressional committees of jurisdiction a 
                notification that the exemption has been approved 
                (together with a description of the circumstances). In 
                the case of classified materials, the notification 
                shall be submitted to the committees, and reviewed by 
                the committees, in accordance with any applicable 
                requirements for such materials.
                    ``(D) An exemption approved by the Secretary under 
                subparagraph (B) takes effect upon the expiration of 
                the 60-day period beginning on the date on which the 
                notification regarding the exemption is submitted under 
                subparagraph (C).
            ``(3) Criteria regarding provision of consent.--In issuing 
        regulations under paragraph (1), the Secretary shall establish 
        requirements for obtaining informed consent, including 
        requirements regarding the information to be provided to the 
        prospective research subject and requirements regarding 
        documentation of the informed consent of such subject.
            ``(4) Noncompliance.--
                    ``(A) An individual aggrieved as a result of a 
                violation of the requirement under paragraph (1) may 
                obtain appropriate relief through a civil action, 
                including damages, equitable relief, and a reasonable 
                attorney's fees and costs. Damages in such an action 
                may include damages other than actual damages.
                    ``(B) With respect to a civil action under 
                subparagraph (A), if the research involved allegedly 
                was conducted by the United States, the defendant shall 
                be the United States. The United States district courts 
                have exclusive original jurisdiction of actions 
                described in the preceding sentence, and such actions 
                may be commenced in a judicial district only in 
                accordance with applicable law on the venue of civil 
                actions.
                    ``(C) With respect to a civil action under 
                subparagraph (A), if the research involved allegedly 
                was conducted by a State, the defendant shall be the 
                head of the State agency involved. Actions described in 
                the preceding sentence may be commenced in any court of 
                competent jurisdiction. For purposes of this 
                subparagraph, a State is not immune under the Eleventh 
                Amendment of the Constitution of the United States from 
                a civil action under subparagraph (A) in Federal court.
                    ``(D) With respect to a civil action under 
                subparagraph (A), if the research involved allegedly 
                was not conducted by the United States or by a State, 
                the entity that allegedly did conduct the research 
                shall be the defendant. Actions described in the 
                preceding sentence may be commenced in any court of 
                competent jurisdiction.
                    ``(E) With respect to the death of an individual 
                who is aggrieved for purposes of subparagraph (A), the 
                cause of action survives the individual and the civil 
                action under such subparagraph may be commenced only by 
                a personal representative of the individual.
                    ``(F) With respect to limitations on commencing a 
                civil action under subparagraph (A)--
                            ``(i) the civil action may not be commenced 
                        after the expiration of the 5-year period 
                        beginning on the date on which the individual 
                        (or the personal representative, as the case 
                        may be) receives notice of the alleged facts 
                        with respect to which the individual is 
                        aggrieved; and
                            ``(ii) notwithstanding clause (i), the 
                        civil action may not be commenced after the 
                        expiration of the 50-year period beginning on 
                        the date on which the individual dies.
            ``(5) Preemption.--This subsection supersedes any private 
        cause of action under the laws of a State arising as a result 
        of the use of an individual as a subject in federally qualified 
        research without the consent of the individual.
            ``(6) Definitions.--For purposes of this subsection:
                    ``(A) The term `federally qualified research' 
                means--
                            ``(i) any research conducted or supported 
                        by the Federal Government; and
                            ``(ii) any research regulated by the 
                        Federal Government, other than research which 
                        is only incidentally regulated.
                    ``(B) The term `principal researcher', with respect 
                to federally qualified research, means the individual 
                with the principal responsibility for conducting the 
                research.''.
    (b) Stylistic Conforming Amendments.--Section 491 of the Public 
Health Service Act (42 U.S.C. 289) is amended--
            (1) in subsection (a), by striking ``(a) The Secretary'' 
        and inserting ``(a) Institutional Review Boards.--The 
        Secretary''; and
            (2) in subsection (b)--
                    (A) by striking ``(b)(1) The Secretary'' and 
                inserting the following:
    ``(b) Ethics Guidance Program.--
            ``(1) In general.--The Secretary''; and
                    (B) in paragraph (2), by striking ``(2) The 
                Secretary'' and inserting the following:
            ``(2) Response respecting violations.--The Secretary''.

SEC. 3. EFFECT ON EXISTING REGULATIONS; EFFECTIVE DATE REGARDING CAUSES 
              OF ACTION.

    (a) Effect on Existing Regulations.--With respect to the provisions 
of part 46 of title 45, Code of Federal Regulations (relating to the 
protection of human subjects), as in effect on the date of the 
enactment of this Act, the legal status of such provisions is affected 
by the amendment made by section 2(a) only to the extent that any such 
provision is inconsistent with the amendment.
    (b) Effective Date Regarding Causes of Action; Applicable 
Provisions.--The requirement established under section 491(c)(1) of the 
Public Health Service Act (as added by the amendment made by section 
2(a) of this Act) is effective in the case of any violation of the 
requirement occurring on or after the date of the enactment of this 
Act, without regard to the date on which final regulations under such 
section take effect. For purposes of the preceding sentence, in the 
case of a cause of action accruing before such regulations take 
effect--
            (1) a defendant is liable, subject to paragraphs (2) and 
        (3), if the principal researcher involved (as defined under 
        such amendment) failed to obtain informed consent in accordance 
        with the provisions of part 46 of title 45, Code of Federal 
        Regulations (relating to the protection of human subjects), as 
        in effect on the date of the enactment of this Act;
            (2) it is a defense that the Secretary of Health and Human 
        Services--
                    (A) determined that the research activity involved 
                was within one of the categories of research described 
                in section 46.101(b) of such part;
                    (B) determined that the research activity otherwise 
                was not covered by the policy; or
                    (C) with respect to informed consent, waived the 
                applicability of the requirements involved; and
            (3) it is not a defense (except as provided in paragraph 
        (2)) that--
                    (A) for purposes of section 46.101(a) of such part, 
                the Federal department or agency involved did not take 
                action to make the policy applicable;
                    (B) for purposes of section 46.101(c) of such part, 
                the department or agency head determined that the 
                research activity was not covered by the policy; or
                    (C) for purposes of section 46.101(i) of such part, 
                the department or agency head waived the applicability 
                of some or all of the provisions of the policy.
Example Output:
Federal Research Informed Consent Act - Amends the Public Health Service Act to direct the Secretary of Health and Human Services to establish the requirement that, in federally qualified research in which any human subject is to be used, the principal researcher obtain the informed consent of the subject.  Allows the Secretary to exempt categories of research from such consent requirement.  Requires congressional notification of such exemptions and a 60-day waiting period before the exemption is effective. 
Directs the Secretary to establish requirements for obtaining informed consent.  Provides for civil actions by those from whom no such consent was obtained, allowing damages, equitable relief, and attorney's fees and costs.  Preempts any State law concerning the obtaining of such consent.