[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 313 Enrolled Bill (ENR)]
S.313
One Hundred Eighth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the seventh day of January, two thousand and three
An Act
To amend the Federal Food, Drug, and Cosmetic Act to establish a program
of fees relating to animal drugs.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Animal Drug User Fee Act of 2003''.
SEC. 2. FINDINGS.
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.
``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 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 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.
``(a) Types of Fees.--Beginning in fiscal year 2004, the Secretary
shall assess and collect fees in accordance with this section as
follows:
``(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. After such fee is paid for that fiscal year,
such fee shall be payable on or before January 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. 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).
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.
``(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) 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. 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 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) 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 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. 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.
``(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.
``(i) 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.
(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) 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) 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 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) 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.
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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.