[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1082 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                S. 1082

 To amend the Federal Food, Drug, and Cosmetic Act to reauthorize and 
    amend the prescription drug user fee provisions, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 10, 2007

  Mr. Kennedy introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to reauthorize and 
    amend the prescription drug user fee provisions, and for other 
                               purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; REFERENCES IN ACT.

    (a) Short Title.--This Act may be cited as the ``Prescription Drug 
User Fee Amendments of 2007''.
    (b) References in Act.--Except as otherwise specified, whenever in 
this Act an amendment is expressed in terms of an amendment to a 
section or other provision, the reference shall be considered to be 
made to a section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).

SEC. 2. DRUG FEES.

    Section 735 (21 U.S.C. 379g) is amended--
            (1) by striking the section designation and all that 
        follows through ``For purposes of this subchapter:'' and 
        inserting the following:

``SEC. 735. DRUG FEES.

    ``(a) Purpose.--It is the purpose of this part that the fees 
authorized under this part be dedicated toward expediting the drug 
development process, the process for the review of human drug 
applications, and postmarket drug safety, as set forth in the goals 
identified for purposes of this subchapter in the letters from the 
Secretary to the Chairman of the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Chairman of the Committee on Energy 
and Commerce of the House of Representatives, as set forth in the 
Congressional Record.
    ``(b) Reports.--
            ``(1) Performance report.--For fiscal years 2008 through 
        2012, not later than 120 days after the end of each fiscal year 
        during which fees are collected under this part, the Secretary 
        shall prepare and submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, a report 
        concerning the progress of the Food and Drug Administration in 
        achieving the goals identified in the letters described in 
        subsection (a) during such fiscal year and the future plans of 
        the Food and Drug Administration for meeting the goals. The 
        report for a fiscal year shall include information on all 
        previous cohorts for which the Secretary has not given a 
        complete response on all human drug applications and 
        supplements in the cohort.
            ``(2) Fiscal report.--For fiscal years 2008 through 2012, 
        not later than 120 days after the end of each fiscal year 
        during which fees are collected under this part, the Secretary 
        shall prepare and submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, 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.
            ``(3) Public availability.--The Secretary shall make the 
        reports required under paragraphs (1) and (2) available to the 
        public on the Internet website of the Food and Drug 
        Administration.
    ``(c) Reauthorization.--
            ``(1) Consultation.--In developing recommendations to 
        present to Congress with respect to the goals, and plans for 
        meeting the goals, for the process for the review of human drug 
        applications for the first 5 fiscal years after fiscal year 
        2012, and for the reauthorization of this part for such fiscal 
        years, the Secretary shall consult with--
                    ``(A) the Committee on Energy and Commerce of the 
                House of Representatives;
                    ``(B) the Committee on Health, Education, Labor, 
                and Pensions of the Senate;
                    ``(C) scientific and academic experts;
                    ``(D) health care professionals;
                    ``(E) representatives of patient and consumer 
                advocacy groups; and
                    ``(F) the regulated industry.
            ``(2) Public review of recommendations.--After negotiations 
        with the regulated industry, the Secretary shall--
                    ``(A) present the recommendations developed under 
                paragraph (1) to the Congressional committees specified 
                in such paragraph;
                    ``(B) publish such recommendations in the Federal 
                Register;
                    ``(C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                    ``(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                    ``(E) after consideration of such public views and 
                comments, revise such recommendations as necessary.
            ``(3) Transmittal of recommendations.--Not later than 
        January 15, 2012, the Secretary shall transmit to Congress the 
        revised recommendations under paragraph (2), a summary of the 
        views and comments received under such paragraph, and any 
        changes made to the recommendations in response to such views 
        and comments.
    ``(d) Definitions.--For purposes of this part:'';
            (2) in subsection (d)--
                    (A) in paragraph (1)--
                            (i) in subparagraph (A), by striking 
                        ``505(b)(1),'' and inserting ``505(b), or'';
                            (ii) by striking subparagraph (B);
                            (iii) by redesignating subparagraph (C) as 
                        subparagraph (B); and
                            (iv) in the matter following subparagraph 
                        (B), as so redesignated, by striking 
                        ``subparagraph (C)'' and inserting 
                        ``subparagraph (B)'';
                    (B) in paragraph (3)(C), by--
                            (i) striking ``the list'' and inserting 
                        ``the list (not including the discontinued 
                        section of such list)''; and
                            (ii) striking ``a list'' and inserting ``a 
                        list (not including the discontinued section of 
                        such a list)'';
                    (C) in paragraph (4), by inserting before the 
                period at the end the following: ``(such as capsules, 
                tablets, and lyophilized products before 
                reconstitution)'';
                    (D) by amending paragraph (6)(F) to read as 
                follows:
                    ``(F) In the case of drugs approved under human 
                drug applications or supplements, postmarket safety 
                activities, including--
                            ``(i) collecting, developing, and reviewing 
                        safety information on approved drugs (including 
                        adverse event reports);
                            ``(ii) developing and using improved 
                        adverse event data collection systems 
                        (including information technology systems); and
                            ``(iii) developing and using improved 
                        analytical tools to assess potential safety 
                        problems (including by accessing external data 
                        bases).'';
                    (E) in paragraph (8)--
                            (i) by striking ``April of the preceding 
                        fiscal year'' and inserting ``October of the 
                        preceding fiscal year''; and
                            (ii) by striking ``April 1997'' and 
                        inserting ``October 1996'';
                    (F) by redesignating paragraph (9) as paragraph 
                (10); and
                    (G) by inserting after paragraph (8) the following:
            ``(9) The term `person' includes an affiliate thereof.''.

SEC. 3. AUTHORITY TO ASSESS AND USE DRUG FEES.

    (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``2003'' and inserting ``2008'';
            (2) in paragraph (1)--
                    (A) in subparagraph (D)--
                            (i) in the heading, by inserting ``or 
                        withdrawn before filing'' after ``refund of fee 
                        if application refused for filing''; and
                            (ii) by inserting before the period at the 
                        end the following: ``or withdrawn without a 
                        waiver before filing'';
                    (B) by redesignating subparagraphs (E) and (F) as 
                subparagraphs (F) and (G), respectively; and
                    (C) by inserting after subparagraph (D) the 
                following:
                    ``(E) Fee for application previously refused for 
                filing or withdrawn before filing.--An application or 
                supplement that has been refused for filing or that was 
                withdrawn before filing, if filed under protest or 
                resubmitted, shall be subject to the fee under 
                subparagraph (A) (unless an exception under 
                subparagraph (C) or (F) applies or the fee is waived or 
                reduced under subsection (d)), without regard to 
                previous payment of such a fee and the refund of 75 
                percent of that fee under subparagraph (D).''; and
            (3) in paragraph (2)--
                    (A) in subparagraph (A), by striking ``subparagraph 
                (B)'' and inserting ``subparagraphs (B) and (C)''; and
                    (B) by adding at the end the following:
                    ``(C) Special rules for compounded positron 
                emission tomography drugs.--
                            ``(i) In general.--Except as provided in 
                        clause (ii), each person who is named as the 
                        applicant in an approved human drug application 
                        for a compounded positron emission tomography 
                        drug shall be subject under subparagraph (A) to 
                        one-quarter of an annual establishment fee with 
                        respect to each such establishment identified 
                        in the application as producing compounded 
                        positron emission tomography drugs under the 
                        approved application.
                            ``(ii) Exception from annual establishment 
                        fee.--Each person who is named as the applicant 
                        in an application described in clause (i) shall 
                        not be assessed an annual establishment fee for 
                        a fiscal year if the person certifies to the 
                        Secretary, at a time specified by the Secretary 
                        and using procedures specified by the 
                        Secretary, that--
                                    ``(I) the person is a not-for-
                                profit medical center that has only 1 
                                establishment for the production of 
                                compounded positron emission tomography 
                                drugs; and
                                    ``(II) at least 95 percent of the 
                                total number of doses of each 
                                compounded positron emission tomography 
                                drug produced by such establishment 
                                during such fiscal year will be used 
                                within the medical center.''.
    (b) Fee Revenue Amounts.--Section 736(b) (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, in each fiscal year beginning 
with fiscal year 2008 and continuing through fiscal year 2012: 
$392,783,000, plus an adjustment for workload on $354,893,000 of this 
amount. Such adjustment shall be made in accordance with the workload 
adjustment provisions in effect for fiscal year 2007, except that 
instead of commercial investigational new drug applications submitted 
to the Secretary, all commercial investigational new drug applications 
with a submission during the previous 12-month period shall be used in 
the determination. One-third of the revenue amount shall be derived 
from application fees, one-third from establishment fees, and one-third 
from product fees.''.
    (c) Adjustments to Fees.--
            (1) Inflation adjustment.--Section 736(c)(1) (21 U.S.C. 
        379h(c)(1)) is amended--
                    (A) in the matter preceding subparagraph (A) by 
                striking ``The revenues established in subsection (b)'' 
                and inserting ``Beginning with fiscal year 2009, the 
                revenues established in subsection (b)'';
                    (B) in subparagraph (A) by striking ``or'' at the 
                end;
                    (C) in subparagraph (B) by striking the period at 
                the end and inserting ``, or,'';
                    (D) by inserting after subparagraph (B) the 
                following:
                    ``(C) the average annual change in the cost, per 
                full-time equivalent position of the Food and Drug 
                Administration, of all personnel compensation and 
                benefits paid with respect to such positions, for the 
                first 5 fiscal years of the previous 6 fiscal years.''; 
                and
                    (E) in the matter following subparagraph (C) (as 
                added by this paragraph), by striking ``fiscal year 
                2003'' and inserting ``fiscal year 2008''.
            (2) Workload adjustment.--Section 736(c)(2) (21 U.S.C. 
        379h(c)(2)) is amended--
                    (A) in the matter preceding subparagraph (A,) by 
                striking ``2004'' and inserting ``2009'';
                    (B) in the first sentence of subparagraph (A)--
                            (i) by striking ``, commercial 
                        investigational new drug applications'' and 
                        inserting ``(adjusted for changes in review 
                        activities)''; and
                            (ii) by inserting before the period at the 
                        end ``, and the change in the number of 
                        commercial investigational new drug 
                        applications with a submission during the 
                        previous 12-month period (adjusted for changes 
                        in review activities)'';
                    (C) in subparagraph (B), by adding at the end the 
                following new sentence: ``Further, any adjustment for 
                changes in review activities made in setting fees and 
                fee revenue amounts for fiscal year 2009 may not result 
                in the total workload adjustment being more than 2 
                percentage points higher than it would be absent the 
                adjustment for changes in review activities.''; and
                    (D) by adding at the end the following:
                    ``(C) The Secretary shall contract with an 
                independent accounting firm to study the adjustment for 
                changes in review activities applied in setting fees 
                for fiscal year 2009 and to make recommendations, if 
                warranted, on future changes in the methodology for 
                calculating the adjustment for changes in review 
                activity. After review of the recommendations by the 
                independent accounting firm, the Secretary shall make 
                appropriate changes to the workload adjustment 
                methodology in setting fees for fiscal years 2010 
                through 2012. If the study is not conducted, no 
                adjustment for changes in review activities shall be 
                made after fiscal year 2009.''.
            (3) Rent and rent-related cost adjustment.--Section 736(c) 
        (21 U.S.C. 379h(c)) is amended--
                    (A) by redesignating paragraphs (3), (4), and (5) 
                as paragraphs (4), (5), and (6), respectively; and
                    (B) by inserting after paragraph (2) the following:
            ``(3) Rent and rent-related cost adjustment.--Beginning in 
        fiscal year 2010, the Secretary shall, before making the 
        adjustments under paragraphs (1) and (2), reduce the fee 
        amounts established in subsection (b), if actual costs paid for 
        rent and rent-related expenses are less than $11,721,000. The 
        reductions made under this paragraph, if any, shall not exceed 
        the amounts by which costs fell below $11,721,000, and shall 
        not exceed $11,721,000 in any fiscal year.''.
            (4) Final year adjustment.--Section 736(c) (21 U.S.C. 
        379h(c)) is amended--
                    (A) in paragraph (4), as redesignated by this 
                subsection--
                            (i) by striking ``2007'' each place it 
                        appears and inserting ``2012''; and
                            (ii) by striking ``2008'' and inserting 
                        ``2013''; and
                    (B) in paragraph (5), as redesignated by this 
                subsection, by striking ``2002'' and inserting 
                ``2007''.
    (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 379h(d)) is 
amended--
            (1) in paragraph (1), in the matter preceding subparagraph 
        (A), by--
                    (A) inserting ``to a person who is named as the 
                applicant'' after ``The Secretary shall grant'';
                    (B) inserting ``to that person'' after ``a waiver 
                from or a reduction of one or more fees assessed''; and
                    (C) striking ``finds'' and inserting 
                ``determines'';
            (2) by redesignating paragraphs (2) and (3) as paragraphs 
        (3) and (4), respectively;
            (3) by inserting after paragraph (1) the following:
            ``(2) Evaluation.--For the purpose of determining whether 
        to grant a waiver or reduction of a fee under paragraph (1), 
        the Secretary shall consider only the circumstances and assets 
        of the applicant and any affiliate of the applicant.''; and
            (4) in paragraph (4), as redesignated by this subsection, 
        in subparagraph (A), by inserting before the period at the end 
        ``, and that does not have a drug product that has been 
        approved under a human drug application and introduced or 
        delivered for introduction into interstate commerce''.
    (e) Crediting and Availability of Fees.--
            (1) Authorization of appropriations.--Section 736(g)(3) (21 
        U.S.C. 379h(g)(3)) is amended to read as follows:
            ``(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this section such 
        sums as are authorized to be assessed and collected under this 
        section in each of fiscal years 2008 through 2012.''.
            (2) Offset.--Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is 
        amended to read as follows:
            ``(4) Offset.--If the cumulative amount of fees collected 
        during fiscal years 2008, 2009, and 2010, plus the amount 
        estimated to be collected for fiscal year 2011, exceeds the 
        amount of fees specified in aggregate in appropriation Acts for 
        such fiscal years, the aggregate amount in excess shall be 
        credited to the appropriation account of the Food and Drug 
        Administration as provided in paragraph (1), and shall be 
        subtracted from the amount of fees that would otherwise be 
        authorized to be collected under this section pursuant to 
        appropriation Acts for fiscal year 2012.''.
    (f) Conforming Amendments.--
            (1) Section 736(a) (21 U.S.C. 379h(a)), as amended by this 
        section, is amended--
                    (A) in paragraph (1)(A), by striking ``subsection 
                (c)(4)'' each place it appears and inserting 
                ``subsection (c)(5)'';
                    (B) in paragraph (2), by striking ``subsection 
                (c)(4)'' and inserting ``subsection (c)(5)''; and
                    (C) in paragraph (3), by striking ``subsection 
                (c)(4)'' and inserting ``subsection (c)(5)''.
            (2) Section 736A(h)(3), as added by section 4 of this Act, 
        is amended by striking ``735(3)'' and inserting ``735(d)(3)''.

SEC. 4. AUTHORITY TO ASSESS AND USE PRESCRIPTION DRUG ADVERTISING FEES.

    Chapter VII, subchapter C, part 2 (21 U.S.C. 379g et seq.) is 
amended by adding after section 736 the following new section:

``SEC. 736A. PROGRAM TO ASSESS AND USE FEES FOR THE ADVISORY REVIEW OF 
              PRESCRIPTION DRUG ADVERTISING.

    ``(a) Types of Direct-to-Consumer Television Advertisement Review 
Fees.--Beginning in fiscal year 2008, the Secretary shall assess and 
collect fees in accordance with this section as follows:
            ``(1) Advisory review fee.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), each person that on or after October 
                1, 2007, submits a proposed direct-to-consumer 
                television advertisement for advisory review by the 
                Secretary prior to its initial public dissemination 
                shall be subject to a fee established under subsection 
                (c)(3).
                    ``(B) Exception for required submissions.--A 
                direct-to-consumer television advertisement that is 
                required to be submitted to the Secretary prior to 
                initial public dissemination shall not be assessed a 
                fee unless the sponsor designates it as a submission 
                for advisory review.
                    ``(C) Payment.--The fee required by subparagraph 
                (A) shall be due no later than October 1 of the fiscal 
                year in which the direct-to-consumer television 
                advertisement shall be submitted to the Secretary for 
                advisory review.
                    ``(D) Modification of advisory review fee.--
                            ``(i) Late payment.--If, on or before 
                        November 1 of the fiscal year in which the fees 
                        are due, a person has not paid all fees that 
                        were due and payable for advisory reviews 
                        identified in response to the Federal Register 
                        notice described in subsection (c)(3)(A), the 
                        fees shall be regarded as late. Such fees shall 
                        be due and payable 20 days before any direct-
                        to-consumer television advertisement is 
                        submitted by such person to the Secretary for 
                        advisory review. Notwithstanding any other 
                        provision of this section, such fees shall be 
                        due and payable for each of those advisory 
                        reviews in the amount of 150 percent of the 
                        advisory review fee established for that fiscal 
                        year pursuant to subsection (c)(3).
                            ``(ii) Late notice of submission.--If any 
                        person submits any direct-to-consumer 
                        television advertisements for advisory review 
                        that are in excess of the number identified by 
                        that person in response to the Federal Register 
                        notice described in subsection (c)(3)(A), that 
                        person must pay a fee for each of those 
                        advisory reviews in the amount of 150 percent 
                        of the advisory review fee established for that 
                        fiscal year pursuant to subsection (c)(3). Fees 
                        under this subparagraph shall be due 20 days 
                        before the direct-to-consumer television 
                        advertisement is submitted by such person to 
                        the Secretary for advisory review.
                    ``(E) Limits.--
                            ``(i) In general.--The payment of a fee 
                        under this paragraph for a fiscal year entitles 
                        the person that pays the fee to acceptance for 
                        advisory review by the Secretary of 1 direct-
                        to-consumer television advertisement and 
                        acceptance of 1 resubmission for advisory 
                        review of the same advertisement. The 
                        advertisement shall be submitted for review in 
                        the fiscal year for which the fee was assessed, 
                        except that a person may carry over no more 
                        than 1 paid advisory review submission to the 
                        next fiscal year. Resubmissions may be 
                        submitted without regard to the fiscal year of 
                        the initial advisory review submission.
                            ``(ii) No refund.--Except as provided by 
                        subsection (f), fees paid under this paragraph 
                        shall not be refunded.
                            ``(iii) No waiver, exemption, or 
                        reduction.--The Secretary shall not grant a 
                        waiver, exemption, or reduction of any fees due 
                        or payable under this section.
                            ``(iv) Non-transferability.--The right to 
                        an advisory review is not transferable, except 
                        to a successor in interest.
            ``(2) Operating reserve fee.--
                    ``(A) In general.--Each person that, on or after 
                October 1, 2007, is assessed an advisory review fee 
                under paragraph (1) shall be subject to an operating 
                reserve fee established under subsection (d)(2) only in 
                the first fiscal year in which an advisory review fee 
                is assessed.
                    ``(B) Payment.--Except as provided in subparagraph 
                (C), the fee required by subparagraph (A) shall be due 
                no later than October 1 of the first fiscal year in 
                which the person is required to pay an advisory review 
                fee under paragraph (1).
                    ``(C) Late notice of submission.--If, in the first 
                fiscal year of a person's participation in the Program, 
                that person submits any direct-to-consumer television 
                advertisements for advisory review that are in excess 
                of the number identified by that person in response to 
                the Federal Register notice described in subsection 
                (c)(3)(A), that person must pay an operating reserve 
                fee for each of those advisory reviews equal to the 
                advisory review fee for each submission established 
                under paragraph (1)(D)(ii). Fees required by this 
                subparagraph shall be in addition to the fees required 
                under subparagraph (B), if any. Fees under this 
                subparagraph shall be due 20 days before any direct-to-
                consumer television advertisement is submitted by such 
                person to the Secretary for advisory review.
    ``(b) Advisory Review Fee Revenue Amounts.--Fees under subsection 
(a)(1) shall be established to generate revenue amounts of $6,250,000 
for each of fiscal years 2008 through 2012, as adjusted pursuant to 
subsection (c).
    ``(c) Adjustments.--
            ``(1) Inflation adjustment.--Beginning with fiscal year 
        2009, the revenues established in subsection (b) shall be 
        adjusted by the Secretary by notice, published in the Federal 
        Register, for a fiscal year to reflect the greater of--
                    ``(A) the total percentage change that occurred in 
                the Consumer Price Index for all urban consumers (all 
                items; United States city average), for the 12-month 
                period ending June 30 preceding the fiscal year for 
                which fees are being established;
                    ``(B) the total percentage change for the previous 
                fiscal year in basic pay under the General Schedule in 
                accordance with section 5332 of title 5, as adjusted by 
                any locality-based comparability payment pursuant to 
                section 5304 of such title for Federal employees 
                stationed in the District of Columbia; or
                    ``(C) the average annual change in the cost, per 
                full-time equivalent position of the Food and Drug 
                Administration, of all personnel compensation and 
                benefits paid with respect to such positions, for the 
                first 5 fiscal years of the previous 6 fiscal years.
        The adjustment made each fiscal year by this subsection shall 
        be added on a compounded basis to the sum of all adjustments 
        made each fiscal year after fiscal year 2008 under this 
        subsection.
            ``(2) Workload adjustment.--
                    ``(A) In general.--Beginning with fiscal year 2009, 
                after the fee revenues established in subsection (b) of 
                this section 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 
                with respect to the submission of proposed direct-to-
                consumer television advertisements for advisory review 
                prior to initial broadcast.
                    ``(B) Determination of workload adjustment.--
                            ``(i) In general.--The workload adjustment 
                        under this paragraph for a fiscal year shall be 
                        determined by the Secretary--
                                    ``(I) based upon the number of 
                                direct-to-consumer television 
                                advertisements identified pursuant to 
                                paragraph (3)(A) for that fiscal year, 
                                excluding allowable previously paid 
                                carry over submissions; and
                                    ``(II) by multiplying the number of 
                                such advertisements projected for that 
                                fiscal year that exceeds 150 by $27,600 
                                (adjusted each year beginning with 
                                fiscal year 2009 for inflation in 
                                accordance with paragraph (1)).
                            ``(ii) Publication in federal register.--
                        The Secretary shall publish in the Federal 
                        Register the fee revenues and fees resulting 
                        from the adjustment and the supporting 
                        methodologies.
                    ``(C) Limitation.--Under no circumstances shall the 
                adjustment result in fee revenues for a fiscal year 
                that are less than the fee revenues established for the 
                prior fiscal year.
            ``(3) Annual fee setting.--
                    ``(A) Number of advertisements.--The Secretary 
                shall, 120 days before the start of each fiscal year, 
                publish a notice in the Federal Register requesting any 
                person to notify the Secretary within 30 days of the 
                number of direct-to-consumer television advertisements 
                the person intends to submit for advisory review by the 
                Secretary in the next fiscal year. Notification to the 
                Secretary of the number of advertisements a person 
                intends to submit for advisory review prior to initial 
                broadcast shall be a legally binding commitment by that 
                person to pay the annual advisory review fee for that 
                number of submissions on or before October 1 of the 
                fiscal year in which the advertisement is intended to 
                be submitted. A person shall at the same time also 
                notify the Secretary if such person intends to use a 
                paid submission from the previous fiscal year under 
                subsection (a)(1)(E)(i). If such person does not so 
                notify the Secretary, all submissions for advisory 
                review shall be subject to advisory review fees.
                    ``(B) Annual fee.--The Secretary shall, 60 days 
                before the start of each fiscal year, establish, for 
                the next fiscal year, the direct-to-consumer television 
                advertisement advisory review fee under subsection 
                (a)(1), based on the revenue amounts established under 
                subsection (b), the adjustments provided under this 
                subsection and the number of direct-to-consumer 
                television advertisements identified pursuant to 
                subparagraph (A), excluding allowable previously paid 
                carry over submissions. The annual advisory review fee 
                shall be established by dividing the fee revenue for a 
                fiscal year (as adjusted pursuant to this subsection) 
                by the number of direct-to-consumer television 
                advertisements identified pursuant to subparagraph (A), 
                excluding allowable previously paid carry over 
                submissions.
                    ``(C) Fiscal year 2008 fee limit.--Notwithstanding 
                subsection (b), the fee established under subparagraph 
                (B) for fiscal year 2008 may not be more than $83,000 
                per submission for advisory review.
                    ``(D) Annual fee limit.--Notwithstanding subsection 
                (b), the fee established under subparagraph (B) for a 
                fiscal year after fiscal year 2008 may not be more than 
                50 percent more than the fee established for the prior 
                fiscal year.
                    ``(E) Limit.--The total amount of fees obligated 
                for a fiscal year may not exceed the total costs for 
                such fiscal year for the resources allocated for the 
                process for the advisory review of prescription drug 
                advertising.
    ``(d) Operating Reserves.--
            ``(1) In general.--The Secretary shall establish in the 
        Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation a Direct-
        to-Consumer Advisory Review Operating Reserve, of at least 
        $6,250,000 in fiscal year 2008, to continue the Program in the 
        event the fees collected in any subsequent fiscal year pursuant 
        to subsection (c)(3) do not generate the fee revenue amount 
        established for that fiscal year.
            ``(2) Fee setting.--The Secretary shall establish the 
        operating reserve fee under subsection (a)(2)(A) for each 
        person required to pay the fee by multiplying the number of 
        direct-to-consumer television advertisements identified by that 
        person pursuant to subsection (c)(3)(A) by the advisory review 
        fee established pursuant to subsection (c)(3) for that fiscal 
        year. In no case shall the operating reserve fee assessed be 
        less than the operating reserve fee assessed if the person had 
        first participated in the Program in fiscal year 2008.
            ``(3) Use of operating reserve.--The Secretary may use 
        funds from the reserves under this subsection only to the 
        extent necessary in any fiscal year to make up the difference 
        between the fee revenue amount established for that fiscal year 
        under subsection (b) and the amount of fees collected for that 
        fiscal year pursuant to subsection (a), or to pay costs of 
        ending the Program if it is terminated pursuant to subsection 
        (f) or if it is not reauthorized after fiscal year 2012.
            ``(4) Refund of operating reserves.--Within 120 days of the 
        end of fiscal year 2012, or if the Program is terminated 
        pursuant to subsection (f), the Secretary, after setting aside 
        sufficient operating reserve amounts to terminate the Program, 
        shall refund all amounts remaining in the operating reserve on 
        a pro rata basis to each person that paid an operating reserve 
        fee assessment. In no event shall the refund to any person 
        exceed the total amount of operating reserve fees paid by such 
        person pursuant to subsection (a)(2).
    ``(e) Effect of Failure To Pay Fees.--Notwithstanding any other law 
or regulation of the Secretary, a submission for advisory review of a 
direct-to-consumer television advertisement submitted by a person 
subject to fees under subsection (a) shall be considered incomplete and 
shall not be accepted for review by the Secretary until all fees owed 
by such person under this section have been paid.
    ``(f) Effect of Inadequate Funding of Program.--
            ``(1) First fiscal year.--If on November 1, 2007, or 120 
        days after enactment of the Prescription Drug User Fee 
        Amendments of 2007, whichever is later, the Secretary has 
        received less than $11,250,000 in advisory review fees and 
        operating reserve fees combined, the Program shall be 
        terminated and all collected fees shall be refunded.
            ``(2) Subsequent fiscal years.--Beginning in fiscal year 
        2009, if, on November 1 of a fiscal year, the combination of 
        the operating reserves, annual fee revenues from that fiscal 
        year, and unobligated fee revenues from prior fiscal years is 
        less than $9,000,000, adjusted for inflation (in accordance 
        with subsection (c)(1)), the Program shall be terminated, and 
        the Secretary shall notify all participants, retain any money 
        from the unused advisory review fees and the operating reserves 
        needed to terminate the Program, and refund the remainder of 
        the unused fees and operating reserves. To the extent required 
        to terminate the Program, the Secretary shall first use 
        unobligated advisory review fee revenues from prior fiscal 
        years, then the operating reserves, and then unused advisory 
        review fees from the relevant fiscal year.
    ``(g) Crediting and Availability of Fees.--
            ``(1) In general.--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. Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salaries and expenses with such 
        fiscal year limitation. The sums transferred shall be available 
        solely for the process for the advisory review of prescription 
        drug advertising.
            ``(2) Collections and appropriation acts.--The fees 
        authorized by this section--
                    ``(A) shall be retained in each fiscal year in an 
                amount not to exceed the amount specified in 
                appropriation Acts, or otherwise made available for 
                obligation for such fiscal year; and
                    ``(B) shall be available for obligation only if 
                appropriated budget authority continues to support at 
                least the total combined number of full-time equivalent 
                employees in the Food and Drug Administration, Center 
                for Drug Evaluation and Research, Division of Drug 
                Marketing, Advertising, and Communications, and the 
                Center for Biologics Evaluation and Research, 
                Advertising and Promotional Labeling Branch supported 
                in fiscal year 2007.
            ``(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this section not 
        less than $6,250,000 for each of fiscal years 2008, 2009, 2010, 
        2011, and 2012, as adjusted to reflect adjustments in the total 
        fee revenues made under this section, plus amounts collected 
        for the reserve fund under subsection (d).
            ``(4) Offset.--Any amount of fees collected for a fiscal 
        year under this section that exceeds the amount of fees 
        specified in appropriation Acts for such fiscal year shall be 
        credited to the appropriation account of the Food and Drug 
        Administration as provided in paragraph (1), and shall be 
        subtracted from the amount of fees that would otherwise be 
        collected under this section pursuant to appropriation Acts for 
        a subsequent fiscal year.
    ``(h) Definitions.--For purposes of this section:
            ``(1) The term `advisory review' means reviewing and 
        providing advisory comments regarding compliance of a proposed 
        advertisement with the requirements of this Act prior to its 
        initial public dissemination.
            ``(2) The term `carry over submission' means a submission 
        for an advisory review for which a fee was paid in a fiscal 
        year that is submitted for review in the following fiscal year.
            ``(3) The term `direct-to-consumer television 
        advertisement' means an advertisement for a prescription drug 
        product as defined in section 735(3) intended to be displayed 
        on any television channel for less than 2 minutes.
            ``(4) The term `person' includes an individual, a 
        partnership, a corporation, and an association, and any 
        affiliate thereof or successor in interest.
            ``(5) The term `Program' means the Program to assess, 
        collect, and use fees for the advisory review of prescription 
        drug advertising established by this section.
            ``(6) The term `process for the advisory review of 
        prescription drug advertising' means the activities necessary 
        to review and provide advisory comments on proposed direct-to-
        consumer television advertisements prior to public 
        dissemination and, to the extent the Secretary has additional 
        staff resources available under the Program that are not 
        necessary for the advisory review of direct-to-consumer 
        television advertisements, the activities necessary to review 
        and provide advisory comments on other proposed advertisements 
        and promotional material prior to public dissemination.
            ``(7) The term `resources allocated for the process for the 
        advisory review of prescription drug advertising' means the 
        expenses incurred in connection with the process for the 
        advisory review of prescription drug advertising for--
                    ``(A) officers and employees of the Food and Drug 
                Administration, contractors of the Food and Drug 
                Administration, advisory committees, and costs related 
                to such officers, employees, and committees, and to 
                contracts with such contractors;
                    ``(B) management of information, and the 
                acquisition, maintenance, and repair of computer 
                resources;
                    ``(C) leasing, maintenance, renovation, and repair 
                of facilities and acquisition, maintenance, and repair 
                of fixtures, furniture, scientific equipment, and other 
                necessary materials and supplies;
                    ``(D) collection of fees under this section and 
                accounting for resources allocated for the advisory 
                review of prescription drug advertising; and
                    ``(E) terminating the Program under subsection 
                (f)(2), if necessary.
            ``(8) The term `resubmission' means a subsequent submission 
        for advisory review of a direct-to-consumer television 
        advertisement that has been revised in response to the 
        Secretary's comments on an original submission. A resubmission 
        may not introduce significant new concepts or creative themes 
        into the television advertisement.
            ``(9) The term `submission for advisory review' means an 
        original submission of a direct-to-consumer television 
        advertisement for which the sponsor voluntarily requests 
        advisory comments before the advertisement is publicly 
        disseminated.''.

SEC. 5. SAVINGS CLAUSE.

    Notwithstanding section 509 of the Prescription Drug User Fee 
Amendments of 2002 (21 U.S.C. 379g note), and notwithstanding the 
amendments made by this Act, 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 enactment of this Act, shall continue 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, 2002, 
but before October 1, 2007, were accepted by the Food and Drug 
Administration for filing with respect to assessing and collecting any 
fee required by such part for a fiscal year prior to fiscal year 2008.

SEC. 6. TECHNICAL AMENDMENTS.

    (a) Section 737 (21 U.S.C. 379i) is amended in the matter preceding 
paragraph (1), by striking ``subchapter'' and inserting ``part''.
    (b) Section 739 (21 U.S.C. 379j-11) is amended in the matter 
preceding paragraph (1), by striking ``subchapter'' and inserting 
``part''.

SEC. 7. EFFECTIVE DATES.

    (a) In General.--Except as provided in subsection (b), the 
amendments made by this Act shall take effect October 1, 2007.
    (b) Exception.--The amendment made by section 4 of this Act shall 
take effect on the date of enactment of this Act.

SEC. 8. SUNSET DATE.

    Sections 735, 736, and 736A of the Federal Food, Drug, and Cosmetic 
Act shall cease to be effective on October 1, 2012.
                                 <all>