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U.S. Department of Health and Human Services

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Title V -- Additional Provisions

Subtitle <<NOTE: Prescription Drug User Fee Amendments of 2002.>>  A--
Prescription Drug User Fees

SEC. 501. <<NOTE: 21 USC 301 note.>>  SHORT TITLE.

    This subtitle may be cited as the ``Prescription Drug User Fee 
Amendments of 2002''.

SEC. 502. <<NOTE: 21 USC 379g note.>>  FINDINGS.

    The Congress finds that--
            (1) prompt approval of safe and effective new drugs and 
        other therapies is critical to the improvement of the public 
        health so that patients may enjoy the benefits provided by these 
        therapies to treat and prevent illness and disease;
            (2) the public health will be served by making additional 
        funds available for the purpose of augmenting the resources of 
        the Food and Drug Administration that are devoted to the process 
        for the review of human drug applications and the assurance of 
        drug safety;
            (3) the provisions added by the Prescription Drug User Fee 
        Act of 1992, as amended by the Food and Drug Administration 
        Modernization Act of 1997, have been successful in
        substantially reducing review times for human drug applications 
        and should be--
                    (A) reauthorized for an additional 5 years, with 
                certain technical improvements; and
                    (B) carried out by the Food and Drug Administration 
                with new commitments to implement more ambitious and 
                comprehensive improvements in regulatory processes of 
                the Food and Drug Administration, including--
                          (i) strengthening and improving the review and 
                      monitoring of drug safety;
                          (ii) considering greater interaction between 
                      the agency and sponsors during the review of drugs 
                      and biologics intended to treat serious diseases 
                      and life-threatening diseases; and
                          (iii) developing principles for improving 
                      first-cycle reviews; and
            (4) the fees authorized by amendments made in this subtitle 
        will be dedicated towards expediting the drug development 
        process and the process for the review of human drug 
        applications as set forth in the goals identified for purposes 
        of part 2 of subchapter C of chapter VII of the Federal Food, 
        Drug, and Cosmetic Act, in the letters from the Secretary of 
        Health and Human Services to the chairman of the Committee on 
        Energy and Commerce of the House of Representatives and the 
        chairman of the Committee on Health, Education, Labor and 
        Pensions of the Senate, as set forth in the Congressional 
        Record.

SEC. 503. DEFINITIONS.

    Section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379g) is amended--
            (1) in paragraph (1), in the matter after and below 
        subparagraph (C), by striking ``licensure, as described in 
        subparagraph (D)'' and inserting ``licensure, as described in 
        subparagraph (C)'';
            (2) in paragraph (3)--
                    (A) in subparagraph (A), by striking ``and'' at the 
                end;
                    (B) in subparagraph (B), by striking the period and 
                inserting ``, and'';
                    (C) by inserting after subparagraph (B) the 
                following subparagraph:
                    ``(C) which is on the list of products described in 
                section 505(j)(7)(A) or is on a list created and 
                maintained by the Secretary of products approved under 
                human drug applications under section 351 of the Public 
                Health Service Act.''; and
                    (D) in the matter after and below subparagraph (C) 
                (as added by subparagraph (C) of this paragraph), by 
                striking ``Service Act,'' and all that follows through 
                ``biological product'' and inserting the following: 
                ``Service Act. Such term does not include a biological 
                product'';
            (3) in paragraph (6), by adding at the end the following 
        subparagraph:
                    ``(F) In the case of drugs approved after October 1, 
                2002, under human drug applications or supplements: 
                collecting, developing, and reviewing safety information 
                on the drugs, including adverse event reports, during a 
                period

[[Page 116 STAT. 689]]

                of time after approval of such applications or 
                supplements, not to exceed three years.''; and
            (4) in paragraph (8)--
                    (A) by striking the matter after and below 
                subparagraph (B);
                    (B) by striking subparagraph (B);
                    (C) by striking ``is the lower of'' and all that 
                follows through ``Consumer Price Index'' and inserting 
                ``is the Consumer Price Index''; and
                    (D) by striking ``1997, or'' and inserting 
                ``1997.''.

SEC. 504. AUTHORITY TO ASSESS AND USE DRUG FEES.

    (a) Types of Fees.--Section 736(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``fiscal year 1998'' and inserting ``fiscal year 2003'';
            (2) in paragraph (1)(A)--
                    (A) in each of clauses (i) and (ii), by striking 
                ``in subsection (b)'' and inserting ``under subsection 
                (c)(4)''; and
                    (B) in clause (ii), by adding at the end the 
                following sentence: ``Such fee shall be half of the 
                amount of the fee established under clause (i).'';
            (3) in paragraph (2)(A), in the matter after and below 
        clause (ii)--
                    (A) by striking ``in subsection (b)'' and inserting 
                ``under subsection (c)(4)''; and
                    (B) by striking ``payable on or before January 31'' 
                and inserting ``payable on or before October 1''; and
            (4) in paragraph (3)--
                    (A) by amending subparagraph (A) to read as follows:
                    ``(A) In general.--Except as provided in 
                subparagraph (B), each person who is named as the 
                applicant in a human drug application, and who, after 
                September 1, 1992, had pending before the Secretary a 
                human drug application or supplement, shall pay for each 
                such prescription drug product the annual fee 
                established under subsection (c)(4). Such fee shall be 
                payable on or before October 1 of each year. Such fee 
                shall be paid only once for each product for a fiscal 
                year in which the fee is payable.''; and
                    (B) in subparagraph (B), by striking ``The listing'' 
                and all that follows through ``filed under section 
                505(b)(2)'' and inserting the following: ``A 
                prescription drug product shall not be assessed a fee 
                under subparagraph (A) if such product is identified on 
                the list compiled under section 505(j)(7)(A) with a 
                potency described in terms of per 100 mL, or if such 
                product is the same product as another product approved 
                under an application filed under section 505(b)''.

    (b) Fee Amounts.--Section 736(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows:
    ``(b) Fee Revenue Amounts.--Except as provided in subsections (c), 
(d), (f), and (g), fees under subsection (a) shall be established to 
generate the following revenue amounts:

``Type of Fee Revenue Fiscal Year 2003 Fiscal Year 2004 Fiscal Year 2005 Fiscal Year 2006 Fiscal Year 2007
Application/Supplement $74,300,000 $77,000,000 $84,000,000 $86,434,000 $86,434,000
Establishment $74,300,000 $77,000,000 $84,000,000 $86,433,000 $86,433,000
Product $74,300,000 $77,000,000 $84,000,000 $86,433,000 $86,433,000
Total Fee Revenue $222,900,000 $231,000,000 $252,000,000 $259,300,000 $259,300,000
If, after the date of the enactment of the Prescription Drug User Fee 
Amendments of 2002, legislation is enacted requiring the Secretary to 
fund additional costs of the retirement of Federal personnel, fee 
revenue amounts shall be increased in each year by the amount necessary 
to fully fund the portion of such additional costs that are attributable 
to the process for the review of human drug applications.''.
    (c) Adjustments.--Section 736(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(c)) is amended--
            (1) in paragraph (1)--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``fees and total fee revenues'' and inserting 
                ``revenues'';
                    (B) in subparagraph (A)--
                          (i) by striking ``during the preceding fiscal 
                      year''; and
                          (ii) by striking ``, or'' and inserting the 
                      following: ``for the 12 month period ending June 
                      30 preceding the fiscal year for which fees are 
                      being established, or'';
                    (C) in subparagraph (B), by striking ``for such 
                fiscal year'' and inserting ``for the previous fiscal 
                year''; and
                    (D) in the matter after and below subparagraph (B), 
                by striking ``fiscal year 1997''; and inserting ``fiscal 
                year 2003'';
            (2) by redesignating paragraphs (2) and (3) as paragraphs 
        (4) and (5), respectively;
            (3) by inserting after paragraph (1) the following 
        paragraphs:
            ``(2) <<NOTE: Effective date.>>  Workload adjustment.--
        Beginning with fiscal year 2004, after the fee revenues 
        established in subsection (b) are adjusted for a fiscal year for 
        inflation in accordance with paragraph (1), the fee revenues 
        shall be adjusted further for such fiscal year to reflect 
        changes in the workload of the Secretary for the process for the 
        review of human drug applications. With respect to such 
        adjustment:
                    ``(A) The adjustment shall be determined by the 
                Secretary based on a weighted average of the change in 
                the total number of human drug applications, commercial 
                investigational new drug applications, efficacy 
                supplements, and manufacturing supplements submitted to 
                the Secretary. <<NOTE: Federal Register, publication.>>  
                The Secretary shall publish in the Federal Register the 
                fee revenues and fees resulting from the adjustment and 
                the supporting methodologies.
                    ``(B) Under no circumstances shall the adjustment 
                result in fee revenues for a fiscal year that are less 
                than the fee revenues for the fiscal year established in 
                subsection (b), as adjusted for inflation under 
                paragraph (1).

            ``(3) Final year adjustment.--For fiscal year 2007, the 
        Secretary may, in addition to adjustments under paragraphs (1) 
        and (2), further increase the fee revenues and fees established 
        in subsection (b) if such an adjustment is necessary to provide 
        for not more than three months of operating reserves of 
        carryover user fees for the process for the review of human drug 
        applications for the first three months of fiscal year 2008. If 
        such an adjustment is necessary, the rationale for the amount of 
        the increase shall be contained in the annual notice 
        establishing fee revenues and fees for fiscal year 2007. If the 
        Secretary has carryover balances for such process in excess of 
        three months of such operating reserves, the adjustment under 
        this paragraph shall not be made.''; and
            (4) in paragraph (4) (as redesignated by paragraph (2) of 
        this subsection), by amending such paragraph to read as follows:
            ``(4) <<NOTE: Effective date.>>  Annual fee setting.--The 
        Secretary shall, 60 days before the start of each fiscal year 
        that begins after September 30, 2002, establish, for the next 
        fiscal year, application, product, and establishment fees under 
        subsection (a), based on the revenue amounts established under 
        subsection (b) and the adjustments provided under this 
        subsection.''.

    (d) Fee Waiver or Reduction.--Section 736(d)) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (C), by inserting ``or'' after 
                the comma at the end;
                    (B) by striking subparagraph (D); and
                    (C) by redesignating subparagraph (E) as 
                subparagraph (D); and
            (2) in paragraph (3), in each of subparagraphs (A) and (B), 
        by striking ``paragraph (1)(E)'' each place such term appears 
        and inserting ``paragraph (1)(D)''.

    (e) Assessment of Fees.--Section 736(f) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h(f)) is amended--
            (1) in the heading for the subsection, by striking 
        ``Assessment of Fees.--'' and inserting ``Limitations.--''; and
            (2) in paragraph (1), by striking the heading for the 
        paragraph and all that follows through ``fiscal year beginning'' 
        and inserting the following: ``In general.--Fees under 
        subsection (a) shall be refunded for a fiscal year beginning''.

    (f) Crediting and Availability of Fees.--
            (1) In general.--Section 736(g)(1) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 379h(g)(1)) is amended by 
        striking ``Fees collected for a fiscal year'' and all that 
        follows through ``fiscal year limitation.'' and inserting the 
        following: ``Fees authorized under subsection (a) shall be 
        collected and available for obligation only to the extent and in 
        the amount provided in advance in appropriations Acts. Such fees 
        are authorized to remain available until expended.''.
            (2) Collections and appropriation acts.--Section 736(g)(2) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        379h(g)(2)) is amended--
                    (A) by redesignating subparagraphs (A) and (B) as 
                clauses (i) and (ii), respectively;
                    (B) by striking ``(2) Collections'' and all that 
                follows through ``the amount specified'' in clause (i) 
                (as so redesignated) and inserting the following:
            ``(2) Collections and appropriation acts.--
                    ``(A) In general.--The fees authorized by this 
                section--
                          ``(i) shall be retained in each fiscal year in 
                      an amount not to exceed the amount specified'';
                    (C) by moving clause (ii) (as so redesignated) two 
                ems to the right; and
                    (D) by adding at the end the following subparagraph:
                    ``(B) Compliance.--The Secretary shall be considered 
                to have met the requirements of subparagraph (A)(ii) in 
                any fiscal year if the costs funded by appropriations 
                and allocated for the process for the review of human 
                drug applications--
                          ``(i) are not more than 3 percent below the 
                      level specified in subparagraph (A)(ii); or
                          ``(ii)(I) are more than 3 percent below the 
                      level specified in subparagraph (A)(ii), and fees 
                      assessed for the fiscal year following the 
                      subsequent fiscal year are decreased by the amount 
                      in excess of 3 percent by which such costs fell 
                      below the level specified in such subparagraph; 
                      and
                          ``(II) such costs are not more than 5 percent 
                      below the level specified in such subparagraph.''.
            (3) Authorization of appropriations.--Section 736(g)(3) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) 
        is amended by striking subparagraphs (A) through (E) and 
        inserting the following:
                    ``(A) $222,900,000 for fiscal year 2003;
                    ``(B) $231,000,000 for fiscal year 2004;
                    ``(C) $252,000,000 for fiscal year 2005;
                    ``(D) $259,300,000 for fiscal year 2006; and
                    ``(E) $259,300,000 for fiscal year 2007;''.

SEC. 505. <<NOTE: Effective dates. Deadlines. 21 USC 379g note.>>  
            ACCOUNTABILITY AND REPORTS.

    (a) Public Accountability.--
            (1) Consultation.--In developing recommendations to the 
        Congress for the goals and plans for meeting the goals for the 
        process for the review of human drug applications for the fiscal 
        years after fiscal year 2007, and for the reauthorization of 
        sections 735 and 736 of the Federal Food, Drug, and Cosmetic 
        Act, the Secretary of Health and Human Services (referred to in 
        this section as the ``Secretary'') shall consult with the 
        Committee on Energy and Commerce of the House of 
        Representatives, the Committee on Health, Education, Labor, and 
        Pensions of the Senate, appropriate scientific and academic 
        experts, health care professionals, representatives of patient 
        and consumer advocacy groups, and the regulated industry.
            (2) <<NOTE: Federal Register, publication.>>  
        Recommendations.--The Secretary shall publish in the Federal 
        Register recommendations under paragraph (1), after negotiations 
        with the regulated industry; shall present such recommendations 
        to the congressional committees specified in such paragraph; 
        shall hold a meeting at which the public may present its views 
        on such recommendations; and shall provide
        for a period of 30 days for the public to provide written 
        comments on such recommendations.

    (b) Performance Report.--Beginning with fiscal year 2003, not later 
than 60 days after the end of each fiscal year during which fees are 
collected under part 2 of subchapter C of chapter VII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of 
Health and Human Services shall prepare and submit to the President, the 
Committee on Energy and Commerce of the House of Representatives, and 
the Committee on Health, Education, Labor, and Pensions of the Senate a 
report concerning the progress of the Food and Drug Administration in 
achieving the goals identified in the letters described in section 
502(4) during such fiscal year and the future plans of the Food and Drug 
Administration for meeting the goals.
    (c) Fiscal Report.--Beginning with fiscal year 2003, not later than 
120 days after the end of each fiscal year during which fees are 
collected under the part described in subsection (b), the Secretary of 
Health and Human Services shall prepare and submit to the Committee on 
Energy and Commerce of the House of Representatives, and the Committee 
on Health, Education, Labor, and Pensions of the Senate, a report on the 
implementation of the authority for such fees during such fiscal year 
and the use, by the Food and Drug Administration, of the fees collected 
during such fiscal year for which the report is made.

SEC. 506. REPORTS OF POSTMARKETING STUDIES.

    Section 506B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356b) is amended by adding at the end the following subsections:
    ``(d) Disclosure.--If a sponsor fails to complete an agreed upon 
study required by this section by its original or otherwise negotiated 
deadline, the Secretary shall publish a statement on the Internet site 
of the Food and Drug Administration stating that the study was not 
completed and, if the reasons for such failure to complete the study 
were not satisfactory to the Secretary, a statement that such reasons 
were not satisfactory to the Secretary.
    ``(e) Notification.--With respect to studies of the type required 
under section 506(b)(2)(A) or under section 314.510 or 601.41 of title 
21, Code of Federal Regulations, as each of such sections was in effect 
on the day before the effective date of this subsection, the Secretary 
may require that a sponsor who, for reasons not satisfactory to the 
Secretary, fails to complete by its deadline a study under any of such 
sections of such type for a drug or biological product (including such a 
study conducted after such effective date) notify practitioners who 
prescribe such drug or biological product of the failure to complete 
such study and the questions of clinical benefit, and, where 
appropriate, questions of safety, that remain unanswered as a result of 
the failure to complete such study. Nothing in this subsection shall be 
construed as altering the requirements of the types of studies required 
under section 506(b)(2)(A) or under section 314.510 or 601.41 of title 
21, Code of Federal Regulations, as so in effect, or as prohibiting the 
Secretary from modifying such sections of title 21 of such Code to 
provide for studies in addition to those of such type.''.

SEC. 507. <<NOTE: 21 USC 379g note.>>  SAVINGS CLAUSE.

    Notwithstanding section 107 of the Food and Drug Administration 
Modernization Act of 1997, and notwithstanding the amendments made by 
this subtitle, part 2 of subchapter C of chapter VII of the Federal 
Food, Drug, and Cosmetic Act, as in effect on the day before the date of 
the enactment of this Act, continues to be in effect with respect to 
human drug applications and supplements (as defined in such part as of 
such day) that, on or after October 1, 1997, but before October 1, 2002, 
were accepted by the Food and Drug Administration for filing and with 
respect to assessing and collecting any fee required by such Act for a 
fiscal year prior to fiscal year 2003.

SEC. 508. <<NOTE: 21 USC 356b note.>>  EFFECTIVE DATE.

    The amendments made by this subtitle shall take effect October 1, 
2002.

SEC. 509. <<NOTE: 21 USC 379g note.>>  SUNSET CLAUSE.

    The amendments made by sections 503 and 504 cease to be effective 
October 1, 2007, and section 505 ceases to be effective 120 days after 
such date.

  Subtitle B--Funding Provisions Regarding Food and Drug Administration

SEC. 521. OFFICE OF DRUG SAFETY.

    Of the amounts appropriated for the Food and Drug Administration for 
a fiscal year, the Secretary of Health and Human Services shall reserve 
for the Office of Drug Safety (within such Administration), the 
following amounts:
            (1) For fiscal year 2003, an amount equal to the sum of 
        $5,000,000 and the amount made available under appropriations 
        Acts for such Office for fiscal year 2002.
            (2) For fiscal year 2004, an amount equal to the sum of 
        $10,000,000 and the amount made available under appropriations 
        Acts for such Office for fiscal year 2002.
            (3) For each subsequent fiscal year, an amount equal to the 
        sum of the amount made available under appropriations Acts for 
        such Office for fiscal year 2004 and an amount sufficient to 
        offset the effects of inflation occurring after the beginning of 
        fiscal year 2004.

SEC. 522. <<NOTE: Appropriation authorization.>>  DIVISION OF DRUG 
            MARKETING, ADVERTISING, AND COMMUNICATIONS.

    For the Division of Drug Marketing, Advertising, and Communications 
(within the Office of Medical Policy, Food and Drug Administration), 
there are authorized to be appropriated the following amounts, stated as 
increases above the amount made available under appropriations Acts for 
such Division for fiscal year 2002:
            (1) For fiscal year 2003, an increase of $2,500,000.
            (2) For fiscal year 2004, an increase of $4,000,000.
            (3) For fiscal year 2005, an increase of $5,500,000.
            (4) For fiscal year 2006, an increase of $7,500,000.
            (5) For fiscal year 2007, an increase of $7,500,000.

[[Page 116 STAT. 695]]

SEC. 523. <<NOTE: Appropriation authorization.>>  OFFICE OF GENERIC 
            DRUGS.

    For the Office of Generic Drugs (within the Food and Drug 
Administration), there are authorized to be appropriated the following 
amounts, stated as increases above the amount made available under 
appropriations Acts for such Office for fiscal year 2002:
            (1) For fiscal year 2003, an increase of $3,000,000.
            (2) For fiscal year 2004, an increase of $6,000,000.
            (3) For fiscal year 2005, an increase of $9,000,000.
            (4) For fiscal year 2006, an increase of $12,000,000.
            (5) For fiscal year 2007, an increase of $15,000,000.

                    Subtitle C--Additional Provisions

SEC. 531. <<NOTE: 47 USC 336 note.>>  TRANSITION TO DIGITAL TELEVISION.

    (a) <<NOTE: Deadline.>>  Pair Assignment Required.--In order to 
further promote the orderly transition to digital television, and to 
promote the equitable allocation and use of digital channels by 
television broadcast permittees and licensees, the Federal 
Communications Commission, at the request of an eligible licensee or 
permittee, shall, within 90 days after the date of enactment of this 
Act, allot, if necessary, and assign a paired digital television channel 
to that licensee or permittee, provided that--
            (1) such channel can be allotted and assigned without 
        further modification of the tables of allotments as set forth in 
        sections 73.606 and 73.622 of the Commission's regulations (47 
        CFR 73.606, 73.622); and
            (2) such allotment and assignment is otherwise consistent 
        with the Commission's rules (47 CFR part 73).

    (b) Eligible Transition Licensee or Permittee.--For purposes of 
subsection (a), the term ``eligible licensee or permittee'' means only a 
full power television broadcast licensee or permittee (or its successor 
in interest) that--
            (1) had an application pending for an analog television 
        station construction permit as of October 24, 1991, which 
        application was granted after April 3, 1997; and
            (2) as of the date of enactment of this Act, is the 
        permittee or licensee of that station.

    (c) Requirements on Licensee or Permittee.--
            (1) Construction deadline.--Any licensee or permittee 
        receiving a paired digital channel pursuant to this section--
                    (A) shall be required to construct the digital 
                television broadcast facility within 18 months of the 
                date on which the Federal Communications Commission 
                issues a construction permit therefore, and
                    (B) shall be prohibited from obtaining or receiving 
                an extension of time from the Commission beyond the 
                construction deadline established by paragraph (1).
            (2) Prohibition of analog operation using digital pair.--Any 
        licensee or permittee receiving a paired digital channel 
        pursuant to this section shall be prohibited from giving up its 
        current paired analog assignment and becoming a single-channel 
        broadcaster and operating in analog on such paired digital 
        channel.

    (d) Relief Restricted.--Any paired digital allotment and assignment 
made under this section shall not be available to any
other applicant unless such applicant is an eligible licensee or 
permittee within the meaning of subsection (b).

SEC. 532. 3-YEAR DELAY IN LOCK IN PROCEDURES FOR MEDICARE+CHOICE PLANS; 
            CHANGE IN CERTAIN MEDICARE+CHOICE DEADLINES AND ANNUAL, 
            COORDINATED ELECTION PERIOD FOR 2003, 2004, AND 2005.

    (a) Lock-In Delay.--Section 1851(e) of the Social Security Act (42 
U.S.C. 1395w-21(e)) is amended--
            (1) in paragraph (2)(A), by striking ``through 2001'' and 
        ``during 1998, 1999, 2000, and 2001'' and inserting ``through 
        2004'' and ``during the period beginning January 1, 1998, and 
        ending on December 31, 2004'', respectively;
            (2) in the heading to paragraph (2)(B), by striking ``during 
        2002'' and inserting ``during 2005'';
            (3) in paragraphs (2)(B)(i) and (2)(C)(i), by striking 
        ``2002'' and inserting ``2005'' each place it appears;
            (4) in paragraph (2)(D), by striking ``2001'' and inserting 
        ``2004''; and
            (5) in paragraph (4), by striking ``2002'' and inserting 
        ``2005'' each place it appears.

    (b) Change in Reporting Deadline.--
            (1) In general.--Section 1854(a)(1) of such Act (42 U.S.C. 
        1395w-24(a)(1)) is amended by striking ``Not later than July 1 
        of each year'' and inserting ``Not later than the second Monday 
        in September of 2002, 2003, and 2004 (or July 1 of each other 
        year)''.
            (2) <<NOTE: Applicability. 42 USC 1395w-24 note.>>  
        Effective date.--The amendment made by paragraph (1) shall apply 
        to information submitted for years beginning with 2003.

    (c) Delay in Annual, Coordinated Election Period.--
            (1) In general.--Section 1851(e) of such Act (42 U.S.C. 
        1395w-21(e)) is amended--
                    (A) in paragraph (3)(B), by striking ``means'' and 
                all that follows and inserting the following: ``means, 
                with respect to a year before 2003 and after 2005, the 
                month of November before such year and with respect to 
                2003, 2004, and 2005, the period beginning on November 
                15 and ending on December 31 of the year before such 
                year.''; and
                    (B) in paragraph (6)(A), by striking ``each 
                subsequent year (as provided in paragraph (3))'' and 
                inserting ``during the annual, coordinated election 
                period under paragraph (3) for each subsequent year''.
            (2) <<NOTE: Applicability. 42 USC 1395w-21 note.>>  
        Effective date.--The amendment made by paragraph (1) shall apply 
        to the annual, coordinated election period for years beginning 
        with 2003.

    (d) Change to Annual Announcement of Payment Rates.--
            (1) In general.--Section 1853(b)(1) of such Act (42 U.S.C. 
        1395w-23(b)(1)) is amended by striking ``not later than March 1 
        before the calendar year concerned'' and inserting ``for years 
        before 2004 and after 2005 not later than March 1 before the 
        calendar year concerned and for 2004 and 2005 not later than the 
        second Monday in May before the respective calendar year''.

            (2) <<NOTE: Applicability. 42 USC 1395w-23 note.>>  
        Effective date.--The amendment made by paragraph (1) shall first 
        apply to announcements for years after 2003.

    Approved June 12, 2002.

LEGISLATIVE HISTORY--H.R. 3448:
---------------------------------------------------------------------------

HOUSE REPORTS: No. 107-481 (Comm. of Conference).
CONGRESSIONAL RECORD:
                                                        Vol. 147 (2001):
                                    Dec. 11, 12, considered and passed 
                                        House.
                                    Dec. 20, considered and passed 
                                        Senate, amended.
                                                        Vol. 148 (2002):
                                    May 22, House agreed to conference 
                                        report.
                                    May 23, Senate agreed to conference 
                                        report.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 38 (2002):
            June 12, Presidential remarks.