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Q: 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.

A: 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.
****
Q: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Services, Education, and 
Rehabilitation for Veterans Act'' or the ``SERV Act''.

SEC. 2. VETERAN'S TREATMENT COURTS.

    (a) Delegation.--The Director of the Office of National Drug 
Control Policy (referred to in this Act as the ``Director'') shall 
delegate the authority to administer the program and other such 
activities necessary to carry out this Act to the Department of 
Justice.
    (b) Grants.--The Attorney General may make grants to States, State 
courts, local courts, units of local government, and Indian tribal 
governments acting directly or through agreements with other public or 
private entities, for the purpose of developing, implementing, or 
enhancing veteran's treatment courts or expanding operational drug 
courts to serve veterans.
    (c) Eligibility.--Grants under this Act shall be made to veteran's 
treatment courts and drug courts serving veterans that effectively 
integrate substance abuse treatment, mental health treatment, mandatory 
drug testing, sanctions and incentives, and transitional services, in a 
judicially supervised court setting with jurisdiction over nonviolent, 
substance-abusing offenders that have served in the United States 
military.

SEC. 3. GRANT AUTHORITY.

    The Attorney General may make grants to States, State courts, local 
courts, units of local government, and Indian tribal governments, 
acting directly or through agreements with other public or private 
entities, for programs that involve--
            (1) continuing judicial supervision over offenders with 
        substance abuse or mental health problems who are not violent 
        offenders and have served in the United States military; and
            (2) the integrated administration of other sanctions and 
        services, which shall include--
                    (A) mandatory periodic testing for the use of 
                controlled substances or other addictive substances 
                during any period of supervised release or probation 
                for each participant;
                    (B) substance abuse and mental health treatment 
                (such as treatment for depression and post-traumatic 
                stress disorder) for each participant;
                    (C) diversion, probation, or other supervised 
                release involving the possibility of prosecution, 
                confinement, or incarceration based on noncompliance 
                with program requirements or failure to show 
                satisfactory progress; and
                    (D) programmatic, offender management, and 
                aftercare services such as relapse prevention, health 
                care, education, vocational training, job placement, 
                housing placement, and child care or other family 
                support services for each participant who requires such 
                services.

SEC. 4. APPLICATIONS.

    (a) In General.--To request a grant under this Act, a State, State 
court, local court, unit of local government, or Indian tribal 
government shall submit an application to the Attorney General in such 
form and containing such information as the Attorney General may 
reasonably require.
    (b) Applications.--In addition to any other requirements that may 
be specified by the Attorney General, an application for a grant under 
this Act shall--
            (1) include a long-term strategy and detailed 
        implementation plan;
            (2) explain the applicant's inability to fund the program 
        adequately without Federal assistance;
            (3) certify that the Federal support provided will be used 
        to supplement, and not supplant, State, Indian tribal, and 
        local sources of funding that would otherwise be available;
            (4) identify related governmental or community initiatives 
        which complement or will be coordinated with the proposal;
            (5) certify that there has been appropriate consultation 
        with all affected agencies, specifically the Department of 
        Veterans Affairs and the Department of Health and Human 
        Services, and that there will be appropriate coordination with 
        all affected agencies in the implementation of the program;
            (6) certify that participating offenders will be supervised 
        by 1 or more designated judges with responsibility for the 
        veteran's treatment court program;
            (7) specify plans for obtaining necessary support and 
        continuing the proposed program following the conclusion of 
        Federal support; and
            (8) describe the methodology that will be used in 
        evaluating the program.
    (c) Certifications.--Each such application shall contain the 
certification that the program for which the grant is requested shall 
meet each of the requirements of this Act.

SEC. 5. FEDERAL SHARE.

    The Federal share of a grant made under this Act may not exceed 75 
percent of the total costs of the program described in the application 
submitted under section 4 for the fiscal year for which the program 
receives assistance under this Act, unless the Attorney General waives, 
wholly or in part, the requirement of a matching contribution under 
this section. In-kind contributions may constitute a portion of the 
non-Federal share of a grant.

SEC. 6. REPORTS AND EVALUATIONS.

    (a) Report to Attorney General and the Director.--For each fiscal 
year, each recipient of a grant under this Act during that fiscal year 
shall submit to the Attorney General, the Director, and the Secretary 
for Veterans Affairs a report regarding the effectiveness of activities 
carried out using that grant. Each report shall include an evaluation 
in such form and containing such information as the Attorney General 
may reasonably require. The Attorney General shall specify the dates on 
which such reports shall be submitted.
    (b) Report to Congress.--The Director, in consultation with the 
Attorney General, shall submit a yearly report on the effectiveness on 
the activities carried out under this Act to the House and Senate 
Committees on the Judiciary and the House and Senate Committees on 
Veterans Affairs.

SEC. 7. DEFINITIONS.

    In this Act:
            (1) Veteran.--The term ``veteran'' means a person who 
        served in the active military, naval, or air service, and who 
        was discharged or released therefrom under conditions other 
        than dishonorable.
            (2) Veteran's treatment court.--The term ``veteran's 
        treatment court'' means a program specifically for veterans 
        that meets the drug court criteria established by the Violent 
        Crime Control and Law Enforcement Act of 1994 (Public Law 103-
        322).
            (3) Violent offender.--The term ``violent offender'' means 
        a person who--
                    (A) is charged with or convicted of an offense, 
                during the course of which offense or conduct--
                            (i) the person carried, possessed, or used 
                        a firearm or dangerous weapon;
                            (ii) there occurred the death of or serious 
                        bodily injury to any person; or
                            (iii) there occurred the use of force 
                        against the person of another, without regard 
                        to whether any of the circumstances described 
                        in clause (i) or (ii) is an element of the 
                        offense or conduct of which or for which the 
                        person is charged or convicted.
                    (B) has 1 or more prior convictions for a felony 
                crime of violence involving the use or attempted use of 
                force against a person with the intent to cause death 
                or serious bodily harm.

SEC. 8. ADMINISTRATION.

    (a) Consultation.--The Attorney General shall consult with the 
Secretary of Veterans Affairs, the Secretary of Health and Human 
Services, and any other appropriate officials in carrying out this Act.
    (b) Regulatory Authority.--
            (1) In general.--The Attorney General may issue regulations 
        and guidelines necessary to carry out this Act.
            (2) Participation limits.--In additional to the general 
        authority provided under paragraph (1), the Attorney General 
        shall--
                    (A) issue regulations and guidelines to ensure that 
                programs authorized in this Act do not permit 
                participation by violent offenders; and
                    (B) immediately suspend funding for any grant under 
                this part, pending compliance, if the Attorney General 
                finds that violent offenders are participating in any 
                program funded under this part.
    (c) Geographic Distribution.--The Attorney General shall ensure 
that, to the extent practicable, an equitable geographic distribution 
of grant awards is made under this Act.

SEC. 9. TECHNICAL ASSISTANCE, TRAINING, AND EVALUATION.

    (a) Technical Assistance and Training.--The Attorney General may 
provide technical assistance and training in furtherance of the 
purposes of this Act.
    (b) Evaluations.--The Attorney General may provide for evaluations 
in furtherance of the purposes of this Act.

SEC. 10. FUNDING FOR THE NATIONAL DRUG COURT INSTITUTE.

    (a) Comprehensive, National Training and Technical Assistance for 
Drug Courts.--The National Drug Court Institute in Alexandria, Virginia 
shall--
            (1) conduct national, comprehensive training programs for 
        State and local communities for the purpose of improving the 
        professional skills of drug court practitioners and enhancing 
        the ability of State and local communities to expand drug 
        courts to reach all addicted citizens in need of their 
        resources; and
            (2) provide national, comprehensive Technical Assistance to 
        adult, juvenile and family dependency drug courts including a 
        combination of information gathering, needs assessment, 
        cultural proficiency, analysis, problem solving, action 
        planning, referral and follow-up.
    (b) Ancillary Projects.--The National Drug Court Institute in 
Alexandria, Virginia shall complete ancillary programs designed to 
facilitate the expansion and improvement of drug courts nationwide 
including--
            (1) a Judicial Task Force to develop a transition plan for 
        new drug court judges;
            (2) a resource center to maintain and distribute drug court 
        evaluations reviewed in the National Drug Court Institute 
        Review, and to request new research and evaluations for the 
        drug court field;
            (3) publishing annually the National Drug Court Institute 
        Review to provide research, analysis, and commentary of 
        importance to the drug court field; and
            (4) searching drug court literature and identify, reprint, 
        and disseminate important and relevant scholarship to the drug 
        court field.
    (c) Authorization of Appropriations.--There are authorized to be 
appropriated to the Attorney General to carry out this section 
$10,000,000 for each of the fiscal years 2009 through 2014 to remain 
available until expended.

SEC. 11. AUTHORIZATION OF APPROPRIATIONS.

    Except for section 10, there are authorized to be appropriated to 
the Director to carry out this Act $25,000,000 for each of fiscal years 
2009 to 2014.

A: Services, Education, and Rehabilitation for Veterans Act or the SERV Act - Requires the Director of the Office of National Drug Control Policy to delegate to the Department of Justice (DOJ) the authority to administer the veteran's treatment courts program established by this Act.

Authorizes the Attorney General to make grants to states and other entities: (1) to develop, implement, or enhance veteran's treatment courts or to expand operational drug courts to serve veterans; and (2) for programs that involve continuing judicial supervision over nonviolent offenders with substance abuse or mental health problems who have served in the U.S. military. Requires such programs to include mandatory periodic testing for the use of drugs, substance abuse and mental health treatment, opportunities for diversion, probation, or supervised release, and programmatic, offender management, and aftercare services.

Directs the National Drug Court Institute to conduct national training programs for state and local communities to improve the professional skills of drug court practitioners and provide comprehensive technical assistance to adult, juvenile, and family dependency drug courts.
****
Q: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Consular Review Act of 1996''.

SEC. 2. ESTABLISHMENT OF A BOARD OF VISA APPEALS.

    (a) In General.--The Immigration and Nationality Act is amended by 
inserting after section 224 the following new section:

                        ``board of visa appeals

    ``Sec. 225. (a) Establishment.--The Secretary of State shall 
establish within the Department of State a Board of Visa Appeals. The 
Board shall be composed of 5 members who shall be appointed by the 
Secretary. No more than 2 members of the Board may be consular 
officers. The Secretary shall designate a member who shall be 
chairperson of the Board.
    ``(b) Authority and Functions.--The Board shall have authority to 
review any discretionary decision of a consular officer with respect to 
an alien concerning the denial, revocation, or cancellation of an 
immigrant visa and of a nonimmigrant visa or petition and the denial of 
an application for waiver of one or more grounds of excludability under 
section 212. The review of the Board shall be made upon the record for 
decision of the consular officer, including all documents, notes, and 
memoranda filed with the consular officer, supplemented by affidavits 
and other writings if offered by the consular officer or alien. Upon a 
conclusive showing that the decision of the consular official is 
contrary to the preponderance of the evidence, the Board shall have 
authority to overrule, or remand for further consideration, the 
decision of such consular officer.
    ``(c) Procedure.--Proceedings before the Board shall be in 
accordance with such regulations, not inconsistent with this Act and 
sections 556 and 557 of title 5, United States Code, as the Secretary 
of State shall prescribe. Such regulations shall include requirements 
that provide that--
            ``(1) at the time of any decision of a consular officer 
        under subsection (b), an alien, attorney of record, and any 
        interested party defined in subsection (d) shall be given 
        notice of the availability of the review process and the 
        necessary steps to request such review,
            ``(2) a written record of the proceedings and decision of 
        the consular officer (in accordance with such sections 556 and 
        557) shall be available to the Board, and on payment of 
        lawfully prescribed costs, shall be made available to the 
        alien,
            ``(3) upon receipt of request for review under this 
        section, the Board shall, within 30 days, notify the consular 
        officer with respect to whose decision review is sought, and, 
        upon receipt of such notice, such officer shall promptly (but 
        in no event more than 30 days after such receipt) forward to 
        the Board the record of proceeding as described in subsection 
        (b),
            ``(4) the appellant shall be given notice, reasonable under 
        all the circumstances of the time and place at which the Board 
        proceedings will be held,
            ``(5) the appellant may be represented (at no expense to 
        the Government) by such counsel, authorized to practice in such 
        proceedings, as the appellant shall choose, and
            ``(6) a request for review under this section must be made 
        in writing to the Board within 60 days after receipt of notice 
        of the denial, revocation or cancellation.
    ``(d) Interested Parties.--The Board shall review each decision 
described in subsection (b) upon request of the alien or any of the 
following interested parties:
            ``(1) The petitioner or beneficiary of an immigrant visa 
        petition approved under section 203(a), 203(b)(1), 203(b)(4), 
        203(b)(5), 203(c), or the petitioner of an immigrant visa 
        petition approved under sections 203(b)(2) and 203(b)(3).
            ``(2) The petitioner of a nonimmigrant visa petition.
            ``(3) The postsecondary educational institution approved 
        for the attendance of nonimmigrant students under section 
        101(a)(15)(F)(i) or 101(a)(15)(M)(i) which has provided notice 
        of the acceptance of the alien in its program.
            ``(4) A recognized international agency or organization 
        approved as a program sponsor under section 101(a)(15)(J) which 
        has provided notice of the acceptance of the alien in its 
        program.
            ``(5) A treaty investor or trader individual or 
        organization in the United States that, under section 
        101(a)(15)(E), has made an offer of employment to an alien to 
        perform executive or supervisory management functions.
    ``(e) Limitation.--A review may not be requested under this section 
more than once in any 24 month period.
    ``(f) Construction.--This section may not be construed to restrict 
any right to further administrative or judicial review established 
under any other provision of law.
    ``(g) Fees.--The Secretary of State shall charge, and collect, an 
appropriate fee associated with a request to the Board for a review. 
Such fee shall be sufficient to cover the cost of the administration of 
this section.''.
    (b) Effective Dates.--
            (1) The amendment made by subsection (a) shall take effect 
        120 days after the date of the enactment of this Act.
            (2) Proposed regulations with respect to the amendment made 
        by subsection (a) shall be promulgated not later than 30 days 
        after the date of the enactment of this Act.
            (3) Members of the Board of Visa Appeals under section 225 
        of the Immigration and Nationality Act (as inserted by 
        subsection (a)) shall be appointed not later than 120 days 
        after the date of the enactment of this Act.
    (c) Technical Amendments.--
            (1) Section 222(f) of the Immigration and Nationality Act 
        (8 U.S.C. 1202(f)) is amended--
                    (A) by striking ``except that'' and all that 
                follows up to the period, and
                    (B) by adding: ``An interested party under section 
                225(d) or court shall be permitted to inspect the 
                record of proceeding as described in subsections (c)(2) 
                and (c)(3) of section 225,''.
            (2) Section 104(a)(1) of such Act (8 U.S.C. 1104(a)(1)) is 
        amended by striking the ``except'' and inserting ``including'',
            (3) The table of contents of such Act is amended by 
        inserting after the item relating to section 224 the following 
        new item:

``Sec. 225. Board of Visa Appeals.''.

A:
Consular Review Act of 1996 - Amends the Immigration and Nationality Act to establish within the Department of State a Board of Visa Appeals to review consular decisions regarding specified visa applications, revocations, and cancellations. 
Provides that Board review requests shall be a fee-based service.
****