S. 313 Text
11-18-03
Became Public Law No: 108-130
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.
`(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.
`(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.
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