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Read the text of HR 2900, the House drug safety bill

HR 2900 IH
110th CONGRESS
1st Session

H. R. 2900

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

June 28, 2007

Mr. DINGELL (for himself, Mr. BARTON of Texas, Mr. PALLONE, Mr. DEAL of Georgia, Mr. WAXMAN, Mr. BARROW, Mr. BUTTERFIELD, Mr. GONZALEZ, Mr. GENE GREEN of Texas, Mr. GORDON of Tennessee, Ms. SOLIS, Mr. MATHESON, Mr. INSLEE, Ms. ESHOO, Ms. HOOLEY, Ms. BALDWIN, Mr. FERGUSON, Mr. ENGEL, Mr. ROSS, Mr. TOWNS, Mr. ROGERS of Michigan, Mr. MARKEY, Ms. DEGETTE, Ms. SCHAKOWSKY, Mr. ALLEN, Mr. BURGESS, Mr. TERRY, Mrs. BONO, Mrs. MYRICK, Mrs. CAPPS, Mr. UPTON, Mr. MELANCON, and Mr. RUSH) introduced the following bill; which was referred to the Committee on Energy and Commerce

________________________________________

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.

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

Key sections of the bill

TITLE I–PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
SEC. 101. SHORT TITLE; REFERENCES IN TITLE.
(a) Short Title- This title may be cited as the `Prescription Drug User Fee Amendments of 2007′.
(b) References in Act- Except as otherwise specified, amendments made by this title to a section or other provision of law are amendments to such section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
SEC. 102. DEFINITIONS.
Section 735 (21 U.S.C. 379g) is amended–
(1) in paragraph (1)–
(A) in subparagraph (A), by striking `505(b)(1),’ and inserting `505(b), or’;
(B) by striking subparagraph (B); and
(C) by redesignating subparagraph (C) as subparagraph (B);
(2) in paragraph (3)(C)–
(A) by striking `505(j)(7)(A)’ and inserting `505(j)(7)(A) (not including the discontinued section of such list),’; and
(B) by inserting before the period `(not including the discontinued section of such list)’;
(3) in paragraph (4), by inserting before the period at the end the following: `(such as capsules, tablets, or lyophilized products before reconstitution)’;
(4) by amending paragraph (6)(F) to read as follows:
`(F) Postmarket safety activities with respect to drugs approved under human drug applications or supplements, including the following activities:
`(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.
`(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.
`(iv) Preparing and making publicly available (including on the website of the Food and Drug Administration) a summary analysis of the adverse drug reaction reports received for recently approved drugs, including identification of any new risks not previously identified, potential new risks, or known risks reported in unusual number not previously identified within 18 months of the drug’s initial marketing or after exposure of 10,000 individuals to the drug, whichever is later.
`(v) Conducting regular, bi-weekly screening of the Adverse Event Reporting System database and developing a report every 15 days on any new safety concerns.
`(vi) Ensuring that the reports available to the public under the Adverse Event Reporting System are updated at least every 6 months.
`(vii) Reporting to the Congress on–
`(I) the recommendations received in consultations with, and reports from, the Office of Surveillance and Epidemiology within the Food and Drug Administration on postmarket safety activities;
`(II) a description of the actions taken on those recommendations; and
`(III) if no action is taken, or a different action is taken relative to the action recommended by the Office of Surveillance and Epidemiology, an explanation of why no action or a different action was taken.
`(viii) On an annual basis, reviewing the entire backlog of postmarket safety commitments to determine which commitments require revision or should be eliminated, reporting to the Congress on these determinations, and assigning start dates and estimated completion dates for such commitments.
`(ix) Developing postmarket safety performance measures, including those listed in clauses (iv) through (viii), that are as measurable and rigorous as the ones already developed for premarket review.’;
(5) in paragraph (8)–
(A) by striking `April of the preceding fiscal year’ and inserting `October of the preceding fiscal year’; and
(B) by striking `April 1997′ and inserting `October 1996′;
(6) by redesignating paragraph (9) as paragraph (11); and
(7) by inserting after paragraph (8) the following paragraphs:
`(9) The term `person’ includes an affiliate thereof.
`(10) The term `active’, with respect to a commercial investigational new drug application, means such an application to which information was submitted during the relevant period.’.
SEC. 103. 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 `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) FEES FOR APPLICATIONS PREVIOUSLY REFUSED FOR FILING OR WITHDRAWN BEFORE FILING- A human drug application or supplement that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived or reduced under subsection (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 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 positron emission tomography drug shall be subject under subparagraph (A) to one-sixth of an annual establishment fee with respect to each such establishment identified in the application as producing 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 positron emission tomography drugs; and
`(II) at least 95 percent of the total number of doses of each positron emission tomography drug produced by such establishment during such fiscal year will be used within the medical center.
`(iii) DEFINITION- For purposes of this subparagraph, the term `positron emission tomography drug’ has the meaning given to the term `compounded positron emission tomography drug’ in section 201(ii), except that subparagraph (1)(B) of such section shall not apply.’.
(b) Fee Revenue Amounts- Section 736(b) (21 U.S.C. 379h(b)) is amended to read as follows:
`(b) Fee Revenue Amounts-
`(1) IN GENERAL- For each of the fiscal years 2008 through 2012, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of–
`(A) $392,783,000; and
`(B) an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3)).
`(2) TYPES OF FEES- Of the total revenue amount determined for a fiscal year under paragraph (1)–
`(A) one-third shall be derived from fees under subsection (a)(1) (relating to human drug applications and supplements);
`(B) one-third shall be derived from fees under subsection (a)(2) (relating to prescription drug establishments); and
`(C) one-third shall be derived from fees under subsection (a)(3) (relating to prescription drug products).
`(3) MODIFIED WORKLOAD ADJUSTMENT FACTOR FOR FISCAL YEAR 2007- For purposes of paragraph (1)(B), the Secretary shall determine the modified workload adjustment factor by determining the dollar amount that results from applying the methodology that was in effect under subsection (c)(2) for fiscal year 2007 to the amount $354,893,000, except that, with respect to the portion of such determination that is based on the change in the total number of commercial investigational new drug applications, the Secretary shall count the number of such applications that were active during the most recent 12-month period for which data on such submissions is available.
`(4) ADDITIONAL FEE REVENUES FOR DRUG SAFETY-
`(A) IN GENERAL- For each of the fiscal years 2008 through 2012, paragraph (1)(A) shall, subject to subparagraph (C), be applied by substituting the amount determined under subparagraph (B) for `$392,783,000′.
`(B) AMOUNT DETERMINED- For each of the fiscal years 2008 through 2012, the amount determined under this subparagraph is the sum of–
`(i) $392,783,000; plus
`(ii) an amount equal to–
`(I)(aa) for fiscal year 2008, $25,000,000;
`(bb) for fiscal year 2009, $35,000,000;
`(cc) for fiscal year 2010, $45,000,000;
`(dd) for fiscal year 2011, $55,000,000; and
`(ee) for fiscal year 2012, $65,000,000; minus
`(II) the amount equal to the excess amount in item (bb), provided that–
`(aa) the amount of the total appropriation for the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of the total appropriation for the Food and Drug Administration for fiscal year 2007 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided under subsection (c)(1); and
`(bb) the amount of the total appropriations for the process of human drug review at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of appropriations for the process of human drug review at the Food and Drug Administration for fiscal year 2007 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided under subsection (c)(1).
In making the adjustment under subclause (II) for any of fiscal years 2008 through 2012, subsection (c)(1) shall be applied by substituting `2007′ for `2008′.
`(C) LIMITATION- This paragraph shall not apply for any fiscal year if the amount described under subparagraph (B)(ii) is less than 0.’.
(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 `For fiscal year 2009 and subsequent fiscal years, 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 years of the preceding 6 fiscal years.’; and
(E) in the matter following subparagraph (C) (as added under 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 `Beginning with fiscal year 2004,’ and inserting `For fiscal year 2009 and subsequent fiscal years,’;
(B) in subparagraph (A), in the first sentence–
(i) by striking `human drug applications,’ and inserting `human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph),’;
(ii) by striking `commercial investigational new drug applications,’; and
(iii) by inserting before the period the following: `, and the change in the total number of active commercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12-month period for which data on such submissions is available’;
(C) in subparagraph (B), by adding at the end the following: `Any adjustment for changes in review activities made in setting fees and revenue amounts for fiscal year 2009 may not result in the total workload adjustment being more than 2 percentage points higher than it would have been in the absence of 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 and revenue amounts for fiscal year 2009 and to make recommendations, if warranted, for future changes in the methodology for calculating the adjustment. After review of the recommendations, the Secretary shall, if warranted, make appropriate changes to the methodology, and the changes shall be effective for each of the fiscal years 2010 through 2012. The Secretary shall not make any adjustment for changes in review activities for any fiscal year after 2009 unless such study has been completed.’.
(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- For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, before making adjustments under paragraphs (1) and (2), decrease the fee revenue amount established in subsection (b) if actual costs paid for rent and rent-related expenses for the preceding fiscal year are less than estimates made for such year in fiscal year 2006. Any reduction made under this paragraph shall not exceed the amount by which such costs fall below the estimates made in fiscal year 2006 for such fiscal year, and shall not exceed $11,721,000 for 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 paragraph (3)(A))–
(i) by striking `2007′ each place it appears and inserting `2012′;
(ii) by striking `paragraphs (1) and (2)’ and inserting `paragraphs (1), (2), and (3)’; and
(iii) by striking `2008′ and inserting `2013′; and
(B) in paragraph (5) (as so redesignated), 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)–
(A) by inserting after `The Secretary shall grant’ the following: `to a person who is named as the applicant in a human drug application’; and
(B) by inserting `to that person’ after `one or more fees assessed’;
(2) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively;
(3) by inserting after paragraph (1) the following:
`(2) CONSIDERATIONS- In 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 involved and any affiliate of the applicant.’; and
(4) in paragraph (4) (as redesignated by paragraph (2)), in subparagraph (A), by inserting before the period the following: `, 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- For each of the fiscal years 2008 through 2012, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c) and paragraph (4) of this subsection.’.
(2) OFFSET- Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is amended to read as follows:
`(4) OFFSET- If the sum of the cumulative amount of fees collected under this section for the fiscal years 2008 through 2010 and the amount of fees estimated to be collected under this section for fiscal year 2011 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2008 through 2011, the 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) Exemption for Orphan Drugs- Section 736 (21 U.S.C. 379h) is further amended by adding at the end the following:
`(k) Orphan Drugs- A drug designated under section 526 for a rare disease or condition and approved under section 505 or under section 351 of the Public Health Service Act shall be exempt from product and facility fees under this section, provided that the drug meets all of the following:
`(1) The drug had United States sales in the previous year of less than $25,000,000 for the active moiety, for all indications, dosage forms, and strengths for which the drug is approved and for any off-label uses.
`(2) The drug meets the public health requirements contained in this Act as such requirements are applied to requests for waivers for product and facility fees.
`(3) The drug is owned or licensed and marketed by a company that had less than $100,000,000 in gross worldwide revenue during the previous year.’.
(g) Conforming Amendment- Section 736(a) (21 U.S.C. 379h(a)) is amended in paragraphs (1)(A)(i), (1)(A)(ii), (2)(A), and (3)(A) by striking `(c)(4)’ each place such term appears and inserting `(c)(5)’.
SEC. 104. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION-DRUG TELEVISION ADVERTISING.
Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.) is amended by adding after section 736 the following:
`SEC. 736A. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION-DRUG TELEVISION 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- With respect to a proposed direct-to-consumer television advertisement (referred to in this section as a `DTC advertisement’), each person that on or after October 1, 2007, submits such an advertisement for advisory review by the Secretary prior to its initial public broadcast (referred to in this section as `prebroadcast advisory review’) shall, except as provided in subparagraph (B), be subject to a fee established under subsection (c)(3).
`(B) EXCEPTION FOR REQUIRED SUBMISSIONS- A DTC advertisement that is required under section 502(n) to be submitted to the Secretary prior to initial public broadcast is not subject to a fee under subparagraph (A) unless the sponsor designates the submission as a submission for prebroadcast advisory review.
`(C) NOTICE TO SECRETARY OF NUMBER OF ADVERTISEMENTS- Not later than June 1 of each fiscal year, the Secretary shall publish a notice in the Federal Register requesting any person to notify the Secretary within 30 days of the number of DTC advertisements the person intends to submit for prebroadcast advisory review in the next fiscal year.
`(D) PAYMENT-
`(i) IN GENERAL- The fee required by subparagraph (A) (referred to in this section as `an advisory review fee’) shall be due not later than October 1 of the fiscal year in which the DTC advertisement involved is intended be submitted for prebroadcast advisory review, subject to subparagraph (F)(i).
`(ii) EFFECT OF SUBMISSION- Notification of the Secretary under subparagraph (C) of the number of DTC advertisements a person intends to submit for prebroadcast advisory review is 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.
`(iii) NOTICE REGARDING CARRYOVER SUBMISSIONS- In making a notification under subparagraph (C), the person involved shall in addition notify the Secretary if under subparagraph (F)(i) the person intends to submit a DTC advertisement for which the advisory review fee has already been paid. If the person does not so notify the Secretary, each DTC advertisement submitted by the person for prebroadcast advisory review in the fiscal year involved shall be subject to the advisory review fee.
`(E) MODIFICATION OF ADVISORY REVIEW FEE-
`(i) LATE PAYMENT- If a person has submitted a notification under subparagraph (C) with respect to a fiscal year and has not paid all advisory review fees due under subparagraph (D) on or before November 1 of such fiscal year, the fees are regarded as late and a revised due date and an increase in the amount of fees applies in accordance with this clause, notwithstanding any other provision of this section. For such person, the advisory review fee for each DTC advertisement submitted in such fiscal year for prebroadcast advisory review shall be due and payable 20 days before the advertisement is submitted to the Secretary, and each such fee shall be revised to be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3).
`(ii) EXCEEDING IDENTIFIED NUMBER OF SUBMISSIONS- If a person submits a number of DTC ads for prebroadcast advisory review in a fiscal year that exceeds the number identified by the person under subparagraph (C), a revised due date and an increase in the amount of fees applies under this clause for each submission in excess of such number, notwithstanding any other provision of this section. For each such DTC ad, the advisory review fee shall be due and payable 20 days before the advertisement is submitted to the Secretary, and the fee shall be revised to be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3).
`(F) LIMITS-
`(i) SUBMISSIONS- For each advisory review fee paid by a person for a fiscal year, the person is entitled to acceptance for advisory review by the Secretary of one DTC advertisement and acceptance of one 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 not more than one 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 REFUNDS- Except as provided by subsection (f), fees paid under subparagraph (A) shall not be refunded.
`(iii) NO WAIVERS, EXEMPTIONS, OR REDUCTIONS- The Secretary shall not grant a waiver, exemption, or reduction of any fees due or payable under this section.
`(iv) RIGHT TO ADVISORY REVIEW NOT TRANSFERABLE- The right to an advisory review under this paragraph 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 fee established under subsection (d)(2) referred to in this section as an `operating reserve fee’ for the first fiscal year in which an advisory review fee is assessed to such person. The person is not subject to an operating reserve fee for any other fiscal year.
`(B) PAYMENT- Except as provided in subparagraph (C), the operating reserve fee 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 under this section, that person submits any DTC advertisements for prebroadcast advisory review that are in excess of the number identified by that person in response to the Federal Register notice described in subsection (a)(1)(C), that person shall 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 any fees required by subparagraph (A). Fees under this subparagraph shall be due 20 days before any DTC advertisement is submitted by such person to the Secretary for prebroadcast 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 subsections (c) and (g)(4).
`(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; U.S. 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, United States Code, 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 will 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- Beginning with fiscal year 2009, 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 with respect to the submission of DTC advertisements for advisory review prior to initial broadcast. With respect to such adjustment:
`(A) The adjustment shall be determined by the Secretary based upon the number of DTC advertisements identified pursuant to subsection (a)(1)(C) for the upcoming fiscal year, excluding allowable previously paid carry over submissions. The adjustment shall be determined 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)). 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 established for the prior fiscal year.
`(3) ANNUAL FEE SETTING FOR ADVISORY REVIEW-
`(A) IN GENERAL- Not later than August 1 of each fiscal year, the Secretary shall establish for the next fiscal year the DTC advertisement advisory review fee under subsection (a)(1), based on the revenue amounts established under subsection (b), the adjustments provided under paragraphs (1) and (2), and the number of DTC advertisements identified pursuant to subsection (a)(1)(C), 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 DTC advertisements so identified, excluding allowable previously-paid carry over submissions.
`(B) FISCAL YEAR 2008 FEE LIMIT- Notwithstanding subsection (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) for fiscal year 2008 may not be more than $83,000 per submission for advisory review.
`(C) ANNUAL FEE LIMIT- Notwithstanding subsection (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) 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.
`(D) 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 under this section in the event the fees collected in any subsequent fiscal year pursuant to subsection (a)(1) 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 DTC advertisements identified by that person pursuant to subsection (a)(1)(C) by the advisory review fee established pursuant to subsection (c)(3) for that fiscal year, except that 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 under this section in fiscal year 2008.
`(3) USE OF OPERATING RESERVE- The Secretary may use funds from the reserves 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 subsections (b) and (c) and the amount of fees actually collected for that fiscal year pursuant to subsection (a)(1), or to pay costs of ending the program under this section if it is terminated pursuant to subsection (f) or not reauthorized beyond fiscal year 2012.
`(4) REFUND OF OPERATING RESERVES- Within 120 days of the end of fiscal year 2012, or if the program under this section ends early pursuant to subsection (f), the Secretary, after setting aside sufficient operating reserve amounts to terminate the program under this section, 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 requirement, a submission for prebroadcast advisory review of a DTC 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) INITIAL FUNDING- If on November 1, 2007, or 120 days after enactment of this provision, whichever is later, the Secretary has not received at least $11,250,000 in advisory review fees and operating reserve fees combined, the program under this section shall not commence and all collected fees shall be refunded.
`(2) LATER FISCAL YEARS- Beginning in fiscal year 2009, if, on November 1 of the fiscal year, the combination of the operating reserves, annual fee revenues from that fiscal year, and unobligated fee revenues from prior fiscal years falls below $9,000,000, adjusted for inflation (as described in subsection (c)(1)), the program under this section shall cease to exist, and the Secretary shall notify all participants, retain any money from the unused advisory review fees and the operating reserves needed to close down the program under this section, and refund the remainder of the unused fees and operating reserves. To the extent required to close down the program under this section, the Secretary shall first use unobligated advisory review fee revenues from prior fiscal years, then the operating reserves, and finally, unused advisory review fees from the relevant fiscal year.
`(g) Crediting and Availability of Fees-
`(1) IN GENERAL- Fees authorized under subsection (a) of this section 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-
`(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 in appropriation Acts, or otherwise made available for obligation for such fiscal year; and
`(ii) shall be available for obligation only if the amounts appropriated as budget authority for such fiscal year are sufficient to support a number of full-time equivalent review employees that is not fewer than the number of such employees supported in fiscal year 2007.
`(B) REVIEW EMPLOYEES- For purposes of subparagraph (A)(ii), the term `full-time equivalent review employees’ means the total combined number of full-time equivalent employees in–
`(i) the Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration; and
`(ii) the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, Food and Drug Administration.
`(3) AUTHORIZATION OF APPROPRIATIONS- For each of the fiscal years 2008 through 2012, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted pursuant to subsection (c) and paragraph (4) of this subsection, 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 subchapter:
`(1) The term `advisory review’ means reviewing and providing advisory comments on a proposed advertisement prior to its initial public broadcast.
`(2) The term `advisory review fee’ has the meaning indicated for such term in subsection (a)(1)(D).
`(3) The term `carry over submission’ means a submission for an advisory review for which a fee was paid in one fiscal year that is submitted for review in the following fiscal year.
`(4) 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 3 minutes.
`(5) The term `DTC advertisement’ has the meaning indicated for such term in subsection (a)(1)(A).
`(6) The term `operating reserve fee’ has the meaning indicated for such term in subsection (a)(2)(A).
`(7) The term `person’ includes an individual, partnership, corporation, and association, and any affiliate thereof or successor in interest.
`(8) The term `prebroadcast advisory review’ has the meaning indicated for such term in subsection (a)(1)(A).
`(9) The term `process for the advisory review of prescription drug advertising’ means the activities necessary to review and provide advisory comments on DTC advertisements prior to public broadcast and, to the extent the Secretary has additional staff resources available under the program under this section that are not necessary for the advisory review of DTC advertisements, the activities necessary to review and provide advisory comments on other proposed advertisements and promotional material prior to public broadcast.
`(10) 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) closing down the program under this section pursuant to subsection (f)(2) if that becomes necessary.
`(11) 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.
`(12) 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. 105. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Report- Beginning with fiscal year 2008, not later than 120 days after the end of each fiscal year for 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 (referred to in this section as the `Secretary’) 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 concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 502(4) of the Prescription Drug User Fee Amendments of 2002 (Subtitle A of title V of Public Law 107-188) during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.
(b) Fiscal Report- Beginning with fiscal year 2008, not later than 120 days after the end of each fiscal year for which fees are collected under the part described in subsection (a), the Secretary 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 for such fiscal year.
(c) Reauthorization-
(1) CONSULTATION- In developing recommendations to present to the 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 and representatives of patient and consumer advocacy groups, 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.
(4) PUBLIC AVAILABILITY OF MINUTES- Before presenting the recommendations developed under paragraphs (1) and (2) to the Congress, the Secretary shall make publicly available, on the public website of the Food and Drug Administration, the minutes of all negotiations conducted under paragraph (1) or (2), as applicable, between the Food and Drug Administration and the regulated industry and representatives of patient and consumer advocacy groups.
SEC. 106. SUNSET DATES.
The amendments made by sections 102, 103, and 104 cease to be effective October 1, 2012.

TITLE VI–REAGAN-UDALL FOUNDATION
SEC. 601. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION.
(a) In General- Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end the following:
`Subchapter I–Reagan-Udall Foundation for the Food and Drug Administration
`SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUNDATION.
`(a) In General- A nonprofit corporation to be known as the Reagan-Udall Foundation for the Food and Drug Administration (referred to in this subchapter as the `Foundation’) shall be established in accordance with this section. The Foundation shall be headed by an Executive Director, appointed by the members of the Board of Directors under subsection (e). The Foundation shall not be an agency or instrumentality of the United States Government.
`(b) Purpose of Foundation- The purpose of the Foundation is to advance the mission of the Food and Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.
`(c) Duties of the Foundation- The Foundation shall–
`(1) taking into consideration the Critical Path reports and priorities published by the Food and Drug Administration, identify unmet needs in the development, manufacture, and evaluation of the safety and effectiveness, including postapproval, of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics, and including the incorporation of more sensitive and predictive tools and devices to measure safety;
`(2) establish goals and priorities in order to meet the unmet needs identified in paragraph (1);
`(3) in consultation with the Secretary, identify existing and proposed Federal intramural and extramural research and development programs relating to the goals and priorities established under paragraph (2), coordinate Foundation activities with such programs, and minimize Foundation duplication of existing efforts;
`(4) award grants to, or enter into contracts, memoranda of understanding, or cooperative agreements with, scientists and entities, which may include the Food and Drug Administration, university consortia, public-private partnerships, institutions of higher education, entities described in section 501(c)(3) of the Internal Revenue Code (and exempt from tax under section 501(a) of such Code), and industry, to efficiently and effectively advance the goals and priorities established under paragraph (2);
`(5) recruit meeting participants and hold or sponsor (in whole or in part) meetings as appropriate to further the goals and priorities established under paragraph (2);
`(6) release and publish information and data and, to the extent practicable, license, distribute, and release material, reagents, and techniques to maximize, promote, and coordinate the availability of such material, reagents, and techniques for use by the Food and Drug Administration, nonprofit organizations, and academic and industrial researchers to further the goals and priorities established under paragraph (2);
`(7) ensure that–
`(A) action is taken as necessary to obtain patents for inventions developed by the Foundation or with funds from the Foundation;
`(B) action is taken as necessary to enable the licensing of inventions developed by the Foundation or with funds from the Foundation; and
`(C) executed licenses, memoranda of understanding, material transfer agreements, contracts, and other such instruments, promote, to the maximum extent practicable, the broadest conversion to commercial and noncommercial applications of licensed and patented inventions of the Foundation to further the goals and priorities established under paragraph (2);
`(8) provide objective clinical and scientific information to the Food and Drug Administration and, upon request, to other Federal agencies to assist in agency determinations of how to ensure that regulatory policy accommodates scientific advances and meets the agency’s public health mission;
`(9) conduct annual assessments of the unmet needs identified in paragraph (1); and
`(10) carry out such other activities consistent with the purposes of the Foundation as the Board determines appropriate.
`(d) Board of Directors-
`(1) ESTABLISHMENT-
`(A) IN GENERAL- The Foundation shall have a Board of Directors (referred to in this subchapter as the `Board’), which shall be composed of ex officio and appointed members in accordance with this subsection. All appointed members of the Board shall be voting members.
`(B) EX OFFICIO MEMBERS- The ex officio members of the Board shall be the following individuals or their designees:
`(i) The Commissioner.
`(ii) The Director of the National Institutes of Health.
`(iii) The Director of the Centers for Disease Control and Prevention.
`(iv) The Director of the Agency for Healthcare Research and Quality.
`(C) APPOINTED MEMBERS-
`(i) IN GENERAL- The ex officio members of the Board under subparagraph (B) shall, by majority vote, appoint to the Board 12 individuals, from a list of candidates to be provided by the National Academy of Sciences. Of such appointed members–
`(I) 4 shall be representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries;
`(II) 3 shall be representatives of academic research organizations;
`(III) 2 shall be representatives of Government agencies, including the Food and Drug Administration and the National Institutes of Health;
`(IV) 2 shall be representatives of patient or consumer advocacy organizations; and
`(V) 1 shall be a representative of health care providers.
`(ii) REQUIREMENT- The ex officio members shall ensure the Board membership includes individuals with expertise in areas including the sciences of developing, manufacturing, and evaluating the safety and effectiveness of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics.
`(D) INITIAL MEETING-
`(i) IN GENERAL- Not later than 30 days after the date of the enactment of this Act, the Secretary shall convene a meeting of the ex officio members of the Board to–
`(I) incorporate the Foundation; and
`(II) appoint the members of the Board in accordance with subparagraph (C).
`(ii) SERVICE OF EX OFFICIO MEMBERS- Upon the appointment of the members of the Board under clause (i)(II), the terms of service of the ex officio members of the Board as members of the Board shall terminate.
`(iii) CHAIR- The ex officio members of the Board under subparagraph (B) shall designate an appointed member of the Board to serve as the Chair of the Board.
`(2) DUTIES OF BOARD- The Board shall–
`(A) establish bylaws for the Foundation that–
`(i) are published in the Federal Register and available for public comment;
`(ii) establish policies for the selection of the officers, employees, agents, and contractors of the Foundation;
`(iii) establish policies, including ethical standards, for the acceptance, solicitation, and disposition of donations and grants to the Foundation and for the disposition of the assets of the Foundation, including appropriate limits on the ability of donors to designate, by stipulation or restriction, the use or recipient of donated funds;
`(iv) establish policies that would subject all employees, fellows, and trainees of the Foundation to the conflict of interest standards under section 208 of title 18, United States Code;
`(v) establish licensing, distribution, and publication policies that support the widest and least restrictive use by the public of information and inventions developed by the Foundation or with Foundation funds to carry out the duties described in paragraphs (6) and (7) of subsection (c), and may include charging cost-based fees for published material produced by the Foundation;
`(vi) specify principles for the review of proposals and awarding of grants and contracts that include peer review and that are consistent with those of the Foundation for the National Institutes of Health, to the extent determined practicable and appropriate by the Board;
`(vii) specify a cap on administrative expenses for recipients of a grant, contract, or cooperative agreement from the Foundation;
`(viii) establish policies for the execution of memoranda of understanding and cooperative agreements between the Foundation and other entities, including the Food and Drug Administration;
`(ix) establish policies for funding training fellowships, whether at the Foundation, academic or scientific institutions, or the Food and Drug Administration, for scientists, doctors, and other professionals who are not employees of regulated industry, to foster greater understanding of and expertise in new scientific tools, diagnostics, manufacturing techniques, and potential barriers to translating basic research into clinical and regulatory practice;
`(x) specify a process for annual Board review of the operations of the Foundation; and
`(xi) establish specific duties of the Executive Director;
`(B) prioritize and provide overall direction to the activities of the Foundation;
`(C) evaluate the performance of the Executive Director; and
`(D) carry out any other necessary activities regarding the functioning of the Foundation.
`(3) TERMS AND VACANCIES-
`(A) TERM- The term of office of each member of the Board appointed under paragraph (1)(C) shall be 4 years, except that the terms of offices for the initial appointed members of the Board shall expire on a staggered basis as determined by the ex officio members.
`(B) VACANCY- Any vacancy in the membership of the Board–
`(i) shall not affect the power of the remaining members to execute the duties of the Board; and
`(ii) shall be filled by appointment by the appointed members described in paragraph (1)(C) by majority vote.
`(C) PARTIAL TERM- If a member of the Board does not serve the full term applicable under subparagraph (A), the individual appointed under subparagraph (B) to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.
`(D) SERVING PAST TERM- A member of the Board may continue to serve after the expiration of the term of the member until a successor is appointed.
`(4) COMPENSATION- Members of the Board may not receive compensation for service on the Board. Such members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the Board, as set forth in the bylaws issued by the Board.
`(e) Incorporation- The ex officio members of the Board shall serve as incorporators and shall take whatever actions necessary to incorporate the Foundation.
`(f) Nonprofit Status- The Foundation shall be considered to be a corporation under section 501(c) of the Internal Revenue Code of 1986, and shall be subject to the provisions of such section.
`(g) Executive Director-
`(1) IN GENERAL- The Board shall appoint an Executive Director who shall serve at the pleasure of the Board. The Executive Director shall be responsible for the day-to-day operations of the Foundation and shall have such specific duties and responsibilities as the Board shall prescribe.
`(2) COMPENSATION- The compensation of the Executive Director shall be fixed by the Board but shall not be greater than the compensation of the Commissioner.
`(h) Administrative Powers- In carrying out this subchapter, the Board, acting through the Executive Director, may–
`(1) adopt, alter, and use a corporate seal, which shall be judicially noticed;
`(2) hire, promote, compensate, and discharge 1 or more officers, employees, and agents, as may be necessary, and define their duties;
`(3) prescribe the manner in which–
`(A) real or personal property of the Foundation is acquired, held, and transferred;
`(B) general operations of the Foundation are to be conducted; and
`(C) the privileges granted to the Board by law are exercised and enjoyed;
`(4) with the consent of the applicable executive department or independent agency, use the information, services, and facilities of such department or agencies in carrying out this section;
`(5) enter into contracts with public and private organizations for the writing, editing, printing, and publishing of books and other material;
`(6) hold, administer, invest, and spend any gift, devise, or bequest of real or personal property made to the Foundation under subsection (i);
`(7) enter into such other contracts, leases, cooperative agreements, and other transactions as the Board considers appropriate to conduct the activities of the Foundation;
`(8) modify or consent to the modification of any contract or agreement to which it is a party or in which it has an interest under this subchapter;
`(9) take such action as may be necessary to obtain patents and licenses for devices and procedures developed by the Foundation and its employees;
`(10) sue and be sued in its corporate name, and complain and defend in courts of competent jurisdiction;
`(11) appoint other groups of advisors as may be determined necessary to carry out the functions of the Foundation; and
`(12) exercise other powers as set forth in this section, and such other incidental powers as are necessary to carry out its powers, duties, and functions in accordance with this subchapter.
`(i) Acceptance of Funds From Other Sources- The Executive Director may solicit and accept on behalf of the Foundation, any funds, gifts, grants, devises, or bequests of real or personal property made to the Foundation, including from private entities, for the purposes of carrying out the duties of the Foundation.
`(j) Service of Federal Employees- Federal Government employees may serve on committees advisory to the Foundation and otherwise cooperate with and assist the Foundation in carrying out its functions, so long as such employees do not direct or control Foundation activities.
`(k) Detail of Government Employees; Fellowships-
`(1) DETAIL FROM FEDERAL AGENCIES- Federal Government employees may be detailed from Federal agencies with or without reimbursement to those agencies to the Foundation at any time, and such detail shall be without interruption or loss of civil service status or privilege. Each such employee shall abide by the statutory, regulatory, ethical, and procedural standards applicable to the employees of the agency from which such employee is detailed and those of the Foundation.
`(2) VOLUNTARY SERVICE; ACCEPTANCE OF FEDERAL EMPLOYEES-
`(A) FOUNDATION- The Executive Director of the Foundation may accept the services of employees detailed from Federal agencies with or without reimbursement to those agencies.
`(B) FOOD AND DRUG ADMINISTRATION- The Commissioner may accept the uncompensated services of Foundation fellows or trainees. Such services shall be considered to be undertaking an activity under contract with the Secretary as described in section 708.
`(l) Annual Reports-
`(1) REPORTS TO FOUNDATION- Any recipient of a grant, contract, fellowship, memorandum of understanding, or cooperative agreement from the Foundation under this section shall submit to the Foundation a report on an annual basis for the duration of such grant, contract, fellowship, memorandum of understanding, or cooperative agreement, that describes the activities carried out under such grant, contract, fellowship, memorandum of understanding, or cooperative agreement.
`(2) REPORT TO CONGRESS AND THE FDA- Beginning with fiscal year 2009, the Executive Director shall submit to Congress and the Commissioner an annual report that–
`(A) describes the activities of the Foundation and the progress of the Foundation in furthering the goals and priorities established under subsection (c)(2), including the practical impact of the Foundation on regulated product development;
`(B) provides a specific accounting of the source and use of all funds used by the Foundation to carry out such activities; and
`(C) provides information on how the results of Foundation activities could be incorporated into the regulatory and product review activities of the Food and Drug Administration.
`(m) Separation of Funds- The Executive Director shall ensure that the funds received from the Treasury are held in separate accounts from funds received from entities under subsection (i).
`(n) Funding- From amounts appropriated to the Food and Drug Administration for each fiscal year, the Commissioner shall transfer not less than $500,000 and not more than $1,250,000, to the Foundation to carry out subsections (a), (b), and (d) through (m).’.
(b) Other Foundation Provisions- Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) (as amended by subsection (a)) is amended by adding at the end the following:
`SEC. 771. LOCATION OF FOUNDATION.
`The Foundation shall, if practicable, be located not more than 20 miles from the District of Columbia.
`SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION.
`(a) In General- The Commissioner shall receive and assess the report submitted to the Commissioner by the Executive Director of the Foundation under section 770(l)(2).
`(b) Report to Congress- Beginning with fiscal year 2009, the Commissioner shall submit to Congress an annual report summarizing the incorporation of the information provided by the Foundation in the report described under section 770(l)(2) and by other recipients of grants, contracts, memoranda of understanding, or cooperative agreements into regulatory and product review activities of the Food and Drug Administration.
`(c) Extramural Grants- The provisions of this subchapter shall have no effect on any grant, contract, memorandum of understanding, or cooperative agreement between the Food and Drug Administration and any other entity entered into before, on, or after the date of enactment of this subchapter.’.
(c) Conforming Amendment- Section 742(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379l(b)) is amended by adding at the end the following: `Any such fellowships and training programs under this section or under section 770(d)(2)(A)(ix) may include provision by such scientists and physicians of services on a voluntary and uncompensated basis, as the Secretary determines appropriate. Such scientists and physicians shall be subject to all legal and ethical requirements otherwise applicable to officers or employees of the Department of Health and Human Services.’.
SEC. 602. OFFICE OF THE CHIEF SCIENTIST.
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following:
`SEC. 910. OFFICE OF THE CHIEF SCIENTIST.
`(a) Establishment; Appointment- The Secretary shall establish within the Office of the Commissioner an office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead such Office.
`(b) Duties of the Office- The Office of the Chief Scientist shall–
`(1) oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the Food and Drug Administration;
`(2) track and, to the extent necessary, coordinate intramural research awards made by each center of the Administration or science-based office within the Office of the Commissioner, and ensure that there is no duplication of research efforts supported by the Reagan-Udall Foundation for the Food and Drug Administration;
`(3) develop and advocate for a budget to support intramural research;
`(4) develop a peer review process by which intramural research can be evaluated; and
`(5) identify and solicit intramural research proposals from across the Food and Drug Administration through an advisory board composed of employees of the Administration that shall include–
`(A) representatives of each of the centers and the science-based offices within the Office of the Commissioner; and
`(B) experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health.’.

For Section 603 and subsequent click here.

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