    [United States Statutes at Large, Volume 117, 108th Congress, 1st Session]
    [From the U.S. Government Publishing Office, www.gpo.gov]

    117 STAT. 1361]]

    Public Law 108-130
    108th Congress

    An Act

    To amend the Federal Food, Drug, and Cosmetic Act to establish a program
    of fees relating to animal drugs. [NOTE: Nov. 18, 2003 -  [S. 313]]

    Be it enacted by the Senate and House of Representatives of the
    United States of America in Congress [NOTE: Animal Drug User Fee Act of
    2003.]  assembled,

    SECTION 1. SHORT TITLE. [NOTE: 21 USC 301 note.]

    This Act may be cited as the ``Animal Drug User Fee Act of 2003''.

    SEC. 2. FINDINGS. [NOTE: 21 USC 379j-11 note.]

    Congress finds as follows:
    (1) Prompt approval of safe and effective new animal drugs
    is critical to the improvement of animal health and the public
    health.
    (2) Animal health and the public health will be served by
    making additional funds available for the purpose of augmenting
    the resources of the Food and Drug Administration that are
    devoted to the process for review of new animal drug
    applications.
    (3) The fees authorized by this Act will be dedicated toward
    expediting the animal drug development process and the review of
    new and supplemental animal drug applications and
    investigational animal drug submissions as set forth in the
    goals identified, for purposes of part 4 of subchapter C of
    chapter VII of the Federal Food, Drug, and Cosmetic Act, in the
    letters from the Secretary of Health and Human Services to the
    Chairman of the Committee on Energy and Commerce of the House of
    Representatives and the Chairman of the Committee on Health,
    Education, Labor, and Pensions of the Senate as set forth in the
    Congressional Record.

    SEC. 3. FEES RELATING TO ANIMAL DRUGS.

    Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
    Act (21 U.S.C. 379f et seq.) is amended by adding at the end the
    following part:

    ``PART 4--FEES RELATING TO ANIMAL DRUGS

    ``SEC. 739. DEFINITIONS. [NOTE: 21 USC 379j-11.]

    ``For purposes of this subchapter:
    ``(1) The term `animal drug application' means an
    application for approval of any new animal drug submitted under
    section 512(b)(1). Such term does not include either a new

    [[Page 1362]]
    117 STAT. 1362

    animal drug application submitted under section 512(b)(2) or a
    supplemental animal drug application.
    ``(2) The term `supplemental animal drug application'
    means--
    ``(A) a request to the Secretary to approve a change
    in an animal drug application which has been approved;
    or
    ``(B) a request to the Secretary to approve a change
    to an application approved under section 512(c)(2) for
    which data with respect to safety or effectiveness are
    required.
    ``(3) The term `animal drug product' means each specific
    strength or potency of a particular active ingredient or
    ingredients in final dosage form marketed by a particular
    manufacturer or distributor, which is uniquely identified by the
    labeler code and product code portions of the national drug
    code, and for which an animal drug application or a supplemental
    animal drug application has been approved.
    ``(4) The term `animal drug establishment' means a foreign
    or domestic place of business which is at one general physical
    location consisting of one or more buildings all of which are
    within 5 miles of each other, at which one or more animal drug
    products are manufactured in final dosage form.
    ``(5) The term `investigational animal drug submission'
    means--
    ``(A) the filing of a claim for an investigational
    exemption under section 512(j) for a new animal drug
    intended to be the subject of an animal drug application
    or a supplemental animal drug application, or
    ``(B) the submission of information for the purpose
    of enabling the Secretary to evaluate the safety or
    effectiveness of an animal drug application or
    supplemental animal drug application in the event of
    their filing.
    ``(6) The term `animal drug sponsor' means either an
    applicant named in an animal drug application, except for an
    approved application for which all subject products have been
    removed from listing under section 510, or a person who has
    submitted an investigational animal drug submission that has not
    been terminated or otherwise rendered inactive by the Secretary.
    ``(7) The term `final dosage form' means, with respect to an
    animal drug product, a finished dosage form which is approved
    for administration to an animal without substantial further
    manufacturing. Such term includes animal drug products intended
    for mixing in animal feeds.
    ``(8) The term `process for the review of animal drug
    applications' means the following activities of the Secretary
    with respect to the review of animal drug applications,
    supplemental animal drug applications, and investigational
    animal drug submissions:
    ``(A) The activities necessary for the review of
    animal drug applications, supplemental animal drug
    applications, and investigational animal drug
    submissions.
    ``(B) The issuance of action letters which approve
    animal drug applications or supplemental animal drug
    applications or which set forth in detail the specific
    deficiencies in animal drug applications, supplemental
    animal

    [[Page 1363]]
    117 STAT. 1363

    drug applications, or investigational animal drug
    submissions and, where appropriate, the actions
    necessary to place such applications, supplements or
    submissions in condition for approval.
    ``(C) The inspection of animal drug establishments
    and other facilities undertaken as part of the
    Secretary's review of pending animal drug applications,
    supplemental animal drug applications, and
    investigational animal drug submissions.
    ``(D) Monitoring of research conducted in connection
    with the review of animal drug applications,
    supplemental animal drug applications, and
    investigational animal drug submissions.
    ``(E) The development of regulations and policy
    related to the review of animal drug applications,
    supplemental animal drug applications, and
    investigational animal drug submissions.
    ``(F) Development of standards for products subject
    to review.
    ``(G) Meetings between the agency and the animal
    drug sponsor.
    ``(H) Review of advertising and labeling prior to
    approval of an animal drug application or supplemental
    animal drug application, but not such activities after
    an animal drug has been approved.
    ``(9) The term `costs of resources allocated for the process
    for the review of animal drug applications' means the expenses
    incurred in connection with the process for the review of animal
    drug applications for--
    ``(A) officers and employees of the Food and Drug
    Administration, contractors of the Food and Drug
    Administration, advisory committees consulted with
    respect to the review of specific animal drug
    applications, supplemental animal drug applications, or
    investigational animal drug submissions, and costs
    related to such officers, employees, committees, and
    contractors, including costs for travel, education, and
    recruitment and other personnel activities,
    ``(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, and
    ``(D) collecting fees under section 740 and
    accounting for resources allocated for the review of
    animal drug applications, supplemental animal drug
    applications, and investigational animal drug
    submissions.
    ``(10) The term `adjustment factor' applicable to a fiscal
    year refers to the formula set forth in section 735(8) with the
    base or comparator year being 2003.
    ``(11) The term `affiliate' refers to the definition set
    forth in section 735(9).

    ``SEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES. [NOTE: 21 USC
    379j-12.]

    ``(a) Types of Fees.--Beginning in fiscal year 2004, the Secretary
    shall assess and collect fees in accordance with this section as
    follows:

    [[Page 1364]]
    117 STAT. 1364

    ``(1) Animal drug application and supplement fee.--
    ``(A) In general.--Each person that submits, on or
    after September 1, 2003, an animal drug application or a
    supplemental animal drug application shall be subject to
    a fee as follows:
    ``(i) A fee established in subsection (b) for
    an animal drug application; and
    ``(ii) A fee established in subsection (b) for
    a supplemental animal drug application for which
    safety or effectiveness data are required, in an
    amount that is equal to 50 percent of the amount
    of the fee under clause (i).
    ``(B) Payment.--The fee required by subparagraph (A)
    shall be due upon submission of the animal drug
    application or supplemental animal drug application.
    ``(C) Exception for previously filed application or
    supplement.--If an animal drug application or a
    supplemental animal drug application was submitted by a
    person that paid the fee for such application or
    supplement, was accepted for filing, and was not
    approved or was withdrawn (without a waiver or refund),
    the submission of an animal drug application or a
    supplemental animal drug application for the same
    product by the same person (or the person's licensee,
    assignee, or successor) shall not be subject to a fee
    under subparagraph (A).
    ``(D) Refund of fee if application refused for
    filing.--The Secretary shall refund 75 percent of the
    fee paid under subparagraph (B) for any animal drug
    application or supplemental animal drug application
    which is refused for filing.
    ``(E) Refund of fee if application withdrawn.--If an
    animal drug application or a supplemental animal drug
    application is withdrawn after the application or
    supplement was filed, the Secretary may refund the fee
    or portion of the fee paid under subparagraph (B) if no
    substantial work was performed on the application or
    supplement after the application or supplement was
    filed. The Secretary shall have the sole discretion to
    refund the fee under this paragraph. A determination by
    the Secretary concerning a refund under this paragraph
    shall not be reviewable.
    ``(2) Animal drug product fee.--Each person--
    ``(A) who is named as the applicant in an animal
    drug application or supplemental animal drug application
    for an animal drug product which has been submitted for
    listing under section 510, and
    ``(B) who, after September 1, 2003, had pending
    before the Secretary an animal drug application or
    supplemental animal drug application;
    shall pay for each such animal drug product the annual fee
    established in subsection (b). Such fee shall be payable for the
    fiscal year in which the animal drug product is first submitted
    for listing under section 510, or is submitted for relisting
    under section 510 if the animal drug product has been withdrawn
    from listing and relisted. [NOTE: Deadline.] After such fee is
    paid for that fiscal year, such fee shall be payable on or
    before January

    [[Page 1365]]
    117 STAT. 1365

    31 of each year. Such fee shall be paid only once for each
    animal drug product for a fiscal year in which the fee is
    payable.
    ``(3) Animal drug establishment fee.--Each person--
    ``(A) who owns or operates, directly or through an
    affiliate, an animal drug establishment, and
    ``(B) who is named as the applicant in an animal
    drug application or supplemental animal drug application
    for an animal drug product which has been submitted for
    listing under section 510, and
    ``(C) who, after September 1, 2003, had pending
    before the Secretary an animal drug application or
    supplemental animal drug application,
    shall be assessed an annual fee established in subsection (b)
    for each animal drug establishment listed in its approved animal
    drug application as an establishment that manufactures the
    animal drug product named in the application. The annual
    establishment fee shall be assessed in each fiscal year in which
    the animal drug product named in the application is assessed a
    fee under paragraph (2) unless the animal drug establishment
    listed in the application does not engage in the manufacture of
    the animal drug product during the fiscal
    year. [NOTE: Deadline.] The fee shall be paid on or before
    January 31 of each year. The establishment shall be assessed
    only one fee per fiscal year under this section: Provided,
    however, That where a single establishment manufactures both
    animal drug products and prescription drug products, as defined
    in section 735(3), such establishment shall be assessed both the
    animal drug establishment fee and the prescription drug
    establishment fee, as set forth in section 736(a)(2), within a
    single fiscal year.
    ``(4) Animal drug sponsor fee.--Each person--
    ``(A) who meets the definition of an animal drug
    sponsor within a fiscal year; and
    ``(B) who, after September 1, 2003, had pending
    before the Secretary an animal drug application, a
    supplemental animal drug application, or an
    investigational animal drug submission,
    shall be assessed an annual fee established under subsection
    (b). [NOTE: Deadline.] The fee shall be paid on or before
    January 31 of each year. Each animal drug sponsor shall pay only
    one such fee each fiscal year.

    ``(b) Fee Amounts.--Except as provided in subsection (a)(1) and
    subsections (c), (d), (f), and (g), the fees required under subsection
    (a) shall be established to generate fee revenue amounts as follows:
    ``(1) Total fee revenues for application and supplement
    fees.--The total fee revenues to be collected in animal drug
    application fees under subsection (a)(1)(A)(i) and supplemental
    animal drug application fees under subsection (a)(1)(A)(ii)
    shall be $1,250,000 in fiscal year 2004, $2,000,000 in fiscal
    year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008.
    ``(2) Total fee revenues for product fees.--The total fee
    revenues to be collected in product fees under subsection (a)(2)
    shall be $1,250,000 in fiscal year 2004, $2,000,000 in fiscal
    year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008.

    [[Page 1366]]
    117 STAT. 1366

    ``(3) Total fee revenues for establishment fees.--The total
    fee revenues to be collected in establishment fees under
    subsection (a)(3) shall be $1,250,000 in fiscal year 2004,
    $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years
    2006, 2007, and 2008.
    ``(4) Total fee revenues for sponsor fees.--The total fee
    revenues to be collected in sponsor fees under subsection (a)(4)
    shall be $1,250,000 in fiscal year 2004, $2,000,000 in fiscal
    year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008.

    ``(c) Adjustments.--
    ``(1) [NOTE: Federal Register, publication.] Inflation
    adjustment.--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; or
    ``(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.
    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 2004 under this subsection.
    ``(2) Workload adjustment.--After the fee revenues are
    adjusted for inflation in accordance with paragraph (1), the fee
    revenues shall be further adjusted each fiscal year after fiscal
    year 2004 to reflect changes in review workload. With respect to
    such adjustment:
    ``(A) This adjustment shall be determined by the
    Secretary based on a weighted average of the change in
    the total number of animal drug applications,
    supplemental animal drug applications for which data
    with respect to safety or effectiveness are required,
    manufacturing supplemental animal drug applications,
    investigational animal drug study submissions, and
    investigational animal drug protocol submissions
    submitted to the Secretary. [NOTE: Federal Register,
    publication.] The Secretary shall publish in the
    Federal Register the fees resulting from this adjustment
    and the supporting methodologies.
    ``(B) Under no circumstances shall this workload
    adjustment result in fee revenues for a fiscal year that
    are less than the fee revenues for that fiscal year
    established in subsection (b), as adjusted for inflation
    under paragraph (1).
    ``(3) Final year adjustment.--For fiscal year 2008, the
    Secretary may further increase the fees to provide for up to 3
    months of operating reserves of carryover user fees for the
    process for the review of animal drug applications for the first
    3 months of fiscal year 2009. If the Food and Drug
    Administration has carryover balances for the process for the

    [[Page 1367]]
    117 STAT. 1367

    review of animal drug applications in excess of 3 months of such
    operating reserves, then this adjustment will not be made. If
    this adjustment is necessary, then the rationale for the amount
    of the increase shall be contained in the annual notice setting
    fees for fiscal year 2008.
    ``(4) [NOTE: Deadline.] Annual fee setting.--The Secretary
    shall establish, 60 days before the start of each fiscal year
    beginning after September 30, 2003, for that fiscal year, animal
    drug application fees, supplemental animal drug application
    fees, animal drug sponsor fees, animal drug establishment fees,
    and animal drug product fees based on the revenue amounts
    established under subsection (b) and the adjustments provided
    under this subsection.
    ``(5) Limit.--The total amount of fees charged, as adjusted
    under this subsection, for a fiscal year may not exceed the
    total costs for such fiscal year for the resources allocated for
    the process for the review of animal drug applications.

    ``(d) Fee Waiver or Reduction.--
    ``(1) In general.--The Secretary shall grant a waiver from
    or a reduction of 1 or more fees assessed under subsection (a)
    where the Secretary finds that--
    ``(A) the assessment of the fee would present a
    significant barrier to innovation because of limited
    resources available to such person or other
    circumstances,
    ``(B) the fees to be paid by such person will exceed
    the anticipated present and future costs incurred by the
    Secretary in conducting the process for the review of
    animal drug applications for such person,
    ``(C) the animal drug application or supplemental
    animal drug application is intended solely to provide
    for use of the animal drug in--
    ``(i) a Type B medicated feed (as defined in
    section 558.3(b)(3) of title 21, Code of Federal
    Regulations (or any successor regulation))
    intended for use in the manufacture of Type C
    free-choice medicated feeds, or
    ``(ii) a Type C free-choice medicated feed (as
    defined in section 558.3(b)(4) of title 21, Code
    of Federal Regulations (or any successor
    regulation)),
    ``(D) the animal drug application or supplemental
    animal drug application is intended solely to provide
    for a minor use or minor species indication, or
    ``(E) the sponsor involved is a small business
    submitting its first animal drug application to the
    Secretary for review.
    ``(2) Use of standard costs.--In making the finding in
    paragraph (1)(B), the Secretary may use standard costs.
    ``(3) Rules for small businesses.--
    ``(A) Definition.--In paragraph (1)(E), the term
    `small business' means an entity that has fewer than 500
    employees, including employees of affiliates.
    ``(B) Waiver of application fee.--The Secretary
    shall waive under paragraph (1)(E) the application fee
    for the first animal drug application that a small
    business or its affiliate submits to the Secretary for
    review. After a small business or its affiliate is
    granted such a waiver, the small business or its
    affiliate shall pay application fees for all

    [[Page 1368]]
    117 STAT. 1368

    subsequent animal drug applications and supplemental
    animal drug applications for which safety or
    effectiveness data are required in the same manner as an
    entity that does not qualify as a small business.
    ``(C) Certification.--The Secretary shall require
    any person who applies for a waiver under paragraph
    (1)(E) to certify their qualification for the
    waiver. [NOTE: Federal Register, publication.] The
    Secretary shall periodically publish in the Federal
    Register a list of persons making such certifications.

    ``(e) Effect of Failure To Pay Fees.--An animal drug application or
    supplemental animal drug application submitted by a person subject to
    fees under subsection (a) shall be considered incomplete and shall not
    be accepted for filing by the Secretary until all fees owed by such
    person have been paid. An investigational animal drug submission under
    section 739(5)(B) that is 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 have been
    paid. The Secretary may discontinue review of any animal drug
    application, supplemental animal drug application or investigational
    animal drug submission from a person if such person has not submitted
    for payment all fees owed under this section by 30 days after the date
    upon which they are due.
    ``(f) Assessment of Fees.--
    ``(1) Limitation.--Fees may not be assessed under subsection
    (a) for a fiscal year beginning after fiscal year 2003 unless
    appropriations for salaries and expenses of the Food and Drug
    Administration for such fiscal year (excluding the amount of
    fees appropriated for such fiscal year) are equal to or greater
    than the amount of appropriations for the salaries and expenses
    of the Food and Drug Administration for the fiscal year 2003
    (excluding the amount of fees appropriated for such fiscal year)
    multiplied by the adjustment factor applicable to the fiscal
    year involved.
    ``(2) Authority.--If the Secretary does not assess fees
    under subsection (a) during any portion of a fiscal year because
    of paragraph (1) and if at a later date in such fiscal year the
    Secretary may assess such fees, the Secretary may assess and
    collect such fees, without any modification in the rate, for
    animal drug applications, supplemental animal drug applications,
    investigational animal drug submissions, animal drug sponsors,
    animal drug establishments and animal drug products at any time
    in such fiscal year notwithstanding the provisions of subsection
    (a) relating to the date fees are to be paid.

    ``(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 be appropriated 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 salary and expenses with such
    fiscal year limitation. The sums transferred shall be available
    solely for the process for the review of animal drug
    applications.

    [[Page 1369]]
    117 STAT. 1369

    ``(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 only be collected and available
    to defray increases in the costs of the resources
    allocated for the process for the review of animal
    drug applications (including increases in such
    costs for an additional number of full-time
    equivalent positions in the Department of Health
    and Human Services to be engaged in such process)
    over such costs, excluding costs paid from fees
    collected under this section, for fiscal year 2003
    multiplied by the adjustment factor.
    ``(B) Compliance.--The Secretary shall be considered
    to have met the requirements of subparagraph (A)(ii) in
    any fiscal year if the costs funded by appropriations
    and allocated for the process for the review of animal
    drug applications--
    ``(i) are not more than 3 percent below the
    level specified in subparagraph (A)(ii); or
    ``(ii)(I) are more than 3 percent below the
    level specified in subparagraph (A)(ii), and fees
    assessed for the fiscal year following the
    subsequent fiscal year are decreased by the amount
    in excess of 3 percent by which such costs fell
    below the level specified in subparagraph (A)(ii);
    and
    ``(II) such costs are not more than 5 percent
    below the level specified in subparagraph (A)(ii).
    ``(3) Authorization of appropriations.--There are authorized
    to be appropriated for fees under this section--
    ``(A) $5,000,000 for fiscal year 2004;
    ``(B) $8,000,000 for fiscal year 2005;
    ``(C) $10,000,000 for fiscal year 2006;
    ``(D) $10,000,000 for fiscal year 2007; and
    ``(E) $10,000,000 for fiscal year 2008;
    as adjusted to reflect adjustments in the total fee revenues
    made under this section and changes in the total amounts
    collected by animal drug application fees, supplemental animal
    drug application fees, animal drug sponsor fees, animal drug
    establishment fees, and animal drug product fees.
    ``(4) Offset.--Any amount of fees collected for a fiscal
    year under this section that exceeds the amount of fees
    specified in appropriations 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
    authorized to be collected under this section pursuant to
    appropriation Acts for a subsequent fiscal year.

    ``(h) Collection of Unpaid Fees.--In any case where the Secretary
    does not receive payment of a fee assessed under subsection (a) within
    30 days after it is due, such fee shall be treated as a claim of the
    United States Government subject to subchapter II of chapter 37 of title
    31, United States Code.

    [[Page 1370]]
    117 STAT. 1370

    ``(i) [NOTE: Deadline.] Written Requests for Waivers, Reductions,
    and Refunds.--To qualify for consideration for a waiver or reduction
    under subsection (d), or for a refund of any fee collected in accordance
    with subsection (a), a person shall submit to the Secretary a written
    request for such waiver, reduction, or refund not later than 180 days
    after such fee is due.

    ``(j) Construction.--This section may not be construed to require
    that the number of full-time equivalent positions in the Department of
    Health and Human Services, for officers, employees, and advisory
    committees not engaged in the process of the review of animal drug
    applications, be reduced to offset the number of officers, employees,
    and advisory committees so engaged.
    ``(k) Abbreviated New Animal Drug Applications.--The Secretary
    shall--
    ``(1) to the extent practicable, segregate the review of
    abbreviated new animal drug applications from the process for
    the review of animal drug applications, and
    ``(2) adopt other administrative procedures to ensure that
    review times of abbreviated new animal drug applications do not
    increase from their current level due to activities under the
    user fee program.''.

    SEC. 4. ACCOUNTABILITY AND REPORTS. [NOTE: 21 USC 379j-11 note.]

    (a) Public Accountability.--
    (1) Consultation.--In developing recommendations to Congress
    for the goals and plans for meeting the goals for the process
    for the review of animal drug applications for the fiscal years
    after fiscal year 2008, and for the reauthorization of sections
    739 and 740 of the Federal Food, Drug, and Cosmetic Act (as
    added by section 3), the Secretary of Health and Human Services
    (referred to in this section as the ``Secretary'') shall consult
    with the Committee on Energy and Commerce of the House of
    Representatives, the Committee on Health, Education, Labor, and
    Pensions of the Senate, appropriate scientific and academic
    experts, veterinary professionals, representatives of consumer
    advocacy groups, and the regulated industry.
    (2) Recommendations.--The Secretary shall--
    (A) [NOTE: Federal Register, publication.] publish
    in the Federal Register recommendations under paragraph
    (1), after negotiations with the regulated industry;
    (B) present the recommendations to the Committees
    referred to in that paragraph;
    (C) hold a meeting at which the public may comment
    on the recommendations; and
    (D) provide for a period of 30 days for the public
    to provide written comments on the recommendations.

    (b) [NOTE: Deadline.] Performance Reports.--Beginning with fiscal
    year 2004, not later than 60 days after the end of each fiscal year
    during which fees are collected under part 4 of subchapter C of chapter
    VII of the Federal Food, Drug, and Cosmetic Act, 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 2(3) of this Act toward expediting the animal drug
    development

    [[Page 1371]]
    117 STAT. 1371

    process and the review of the new and supplemental animal drug
    applications and investigational animal drug submissions during such
    fiscal year, the future plans of the Food and Drug Administration for
    meeting the goals, the review times for abbreviated new animal drug
    applications, and the administrative procedures adopted by the Food and
    Drug Administration to ensure that review times for abbreviated new
    animal drug applications are not increased from their current level due
    to activities under the user fee program.

    (c) [NOTE: Deadline.] Fiscal Report.--Beginning with fiscal year
    2004, not later than 120 days after the end of each fiscal year during
    which fees are collected under the part described in subsection (b), the
    Secretary shall prepare and submit to the Committee on Energy and
    Commerce of the House of Representatives and the Committee on Health,
    Education, Labor, and Pensions of the Senate a report on the
    implementation of the authority for such fees during such fiscal year
    and the use, by the Food and Drug Administration, of the fees collected
    during such fiscal year for which the report is made.

    SEC. 5. SUNSET. [NOTE: 21 USC 379j-11 note.]

    The amendments made by section 3 shall not be in effect after
    October 1, 2008, and section 4 shall not be in effect after 120 days
    after such date.

    Approved November 18, 2003.

    LEGISLATIVE HISTORY--S. 313:
    ---------------------------------------------------------------------------

    SENATE REPORTS: No. 108-51 (Comm. on Health, Education, Labor, and
    Pensions).
    CONGRESSIONAL RECORD, Vol. 149 (2003):
    May 23, considered and passed Senate.
    June 3, passage vitiated; reconsidered and passed Senate.
    Nov. 4, considered and passed House, amended.
    Nov. 7, Senate concurred in House amendment.
    WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 39 (2003):
    Nov. 18, Presidential statement.