[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6433 Reported in House (RH)]
Union Calendar No. 521
110th CONGRESS
2d Session
H. R. 6433
[Report No. 110-805]
To amend the Federal Food, Drug, and Cosmetic Act to establish a
program of fees relating to generic new animal drugs.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 8, 2008
Mr. Pallone (for himself, Mr. Dingell, Mr. Barton of Texas, Mr. Deal of
Georgia, and Mr. Towns) introduced the following bill; which was
referred to the Committee on Energy and Commerce
July 30, 2008
Additional sponsor: Ms. DeGette
July 30, 2008
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed
in italic]
[For text of introduced bill, see copy of bill as introduced on July 8,
2008]
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to establish a
program of fees relating to generic new 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; REFERENCES.
(a) Short Title.--This Act may be cited as the ``Animal Generic
Drug User Fee Act of 2008''.
(b) References in Act.--Except as otherwise specified, amendments
made by this Act to a section or other provision of law are amendments
to such section or other provision of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).
SEC. 2. FINDINGS.
Congress finds as follows:
(1) Prompt approval of abbreviated applications for safe
and effective generic new animal drugs will reduce animal
healthcare costs and promote the well-being 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 the review of abbreviated
applications for the approval of generic new animal drugs.
(3) The fees authorized by this Act will be dedicated
toward expediting the generic new animal drug development
process and the review of abbreviated applications for generic
new animal drugs, supplemental abbreviated applications for
generic new animal drugs, and investigational submissions for
generic new animal drugs as set forth in the goals identified
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 ABBREVIATED APPLICATIONS FOR GENERIC NEW
ANIMAL DRUGS.
(a) Redesignation.--Chapter VII (21 U.S.C. 371 et seq.) is amended
by redesignating sections 741, 742, and 746 as sections 745, 746, and
749, respectively.
(b) Authority To Assess and Use Generic New Animal Drug Fees.--
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 5--FEES RELATING TO GENERIC NEW ANIMAL DRUGS
``SEC. 741. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES.
``(a) Types of Fees.--Beginning with respect to fiscal year 2009,
the Secretary shall assess and collect fees in accordance with this
section as follows:
``(1) Abbreviated application fee.--
``(A) In general.--Each person that submits, on or
after July 1, 2008, an abbreviated application for a
generic new animal drug shall be subject to a fee as
established in subsection (b) for such an application.
``(B) Payment.--The fee required by subparagraph
(A) shall be due upon submission of the abbreviated
application.
``(C) Exception for previously filed application.--
If an abbreviated application was submitted by a person
that paid the fee for such application, was accepted
for filing, and was not approved or was withdrawn
(without a waiver or refund), the submission of an
abbreviated 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 abbreviated
application which is refused for filing.
``(E) Refund of fee if application withdrawn.--If
an abbreviated application is withdrawn after the
application 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 after
the application was filed. The Secretary shall have the
sole discretion to refund the fee under this
subparagraph. A determination by the Secretary
concerning a refund under this subparagraph shall not
be reviewable.
``(2) Generic new animal drug product fee.--Each person--
``(A) who is named as the applicant in an
abbreviated application or supplemental abbreviated
application for a generic new animal drug product which
has been submitted for listing under section 510, and
``(B) who, after September 1, 2008, had pending
before the Secretary an abbreviated application or
supplemental abbreviated application,
shall pay for each such generic new animal drug product the
annual fee established in subsection (b). Such fee shall be
payable for the fiscal year in which the generic new animal
drug product is first submitted for listing under section 510,
or is submitted for relisting under section 510 if the generic
new 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 generic new animal drug
product for a fiscal year in which the fee is payable.
``(3) Generic new animal drug sponsor fee.--
``(A) In general.--Each person--
``(i) who meets the definition of a generic
new animal drug sponsor within a fiscal year,
and
``(ii) who, after September 1, 2008, had
pending before the Secretary an abbreviated
application, a supplemental abbreviated
application, or an investigational submission,
shall be assessed an annual fee established under
subsection (b). The fee shall be paid on or before
January 31 of each year.
``(B) Amount of fee.--Each generic new animal drug
sponsor shall pay only 1 such fee each fiscal year, as
follows:
``(i) 100 percent of the amount of the
generic new animal drug sponsor fee published
for that fiscal year under subsection (c)(3)
for an applicant with more than 6 approved
abbreviated applications.
``(ii) 75 percent of the amount of the
generic new animal drug sponsor fee published
for that fiscal year under subsection (c)(3)
for an applicant with more than 1 and fewer
than 7 approved abbreviated applications.
``(iii) 50 percent of the amount of the
generic new animal drug sponsor fee published
for that fiscal year under subsection (c)(3)
for an applicant with 1 or fewer approved
abbreviated applications.
``(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 fees.--The total
fee revenues to be collected in abbreviated application fees
under subsection (a)(1) shall be $1,449,000 for fiscal year
2009, $1,532,000 for fiscal year 2010, $1,619,000 for fiscal
year 2011, $1,712,000 for fiscal year 2012, and $1,809,000 for
fiscal year 2013.
``(2) Total fee revenues for product fees.--The total fee
revenues to be collected in generic new animal drug product
fees under subsection (a)(2) shall be $1,691,000 for fiscal
year 2009, $1,787,000 for fiscal year 2010, $1,889,000 for
fiscal year 2011, $1,997,000 for fiscal year 2012, and
$2,111,000 for fiscal year 2013.
``(3) Total fee revenues for sponsor fees.--The total fee
revenues to be collected in generic new animal drug sponsor
fees under subsection (a)(3) shall be $1,691,000 for fiscal
year 2009, $1,787,000 for fiscal year 2010, $1,889,000 for
fiscal year 2011, $1,997,000 for fiscal year 2012, and
$2,111,000 for fiscal year 2013.
``(c) Adjustments.--
``(1) Workload adjustment.--The fee revenues shall be
adjusted each fiscal year after fiscal year 2009 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 abbreviated applications for
generic new animal drugs, manufacturing supplemental
abbreviated applications for generic new animal drugs,
investigational generic new animal drug study
submissions, and investigational generic new 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).
``(2) Final year adjustment.--For fiscal year 2013, 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 abbreviated applications for generic
new animal drugs for the first 3 months of fiscal year 2014. If
the Food and Drug Administration has carryover balances for the
process for the review of abbreviated applications for generic
new animal drugs in excess of 3 months of such operating
reserves, then this adjustment shall 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 2013.
``(3) Annual fee setting.--The Secretary shall establish,
60 days before the start of each fiscal year beginning after
September 30, 2008, for that fiscal year, abbreviated
application fees, generic new animal drug sponsor fees, and
generic new animal drug product fees based on the revenue
amounts established under subsection (b) and the adjustments
provided under this subsection.
``(4) 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 abbreviated applications for
generic new animal drugs.
``(d) Fee Waiver or Reduction.--The Secretary shall grant a waiver
from or a reduction of 1 or more fees assessed under subsection (a)
where the Secretary finds that the generic new animal drug is intended
solely to provide for a minor use or minor species indication.
``(e) Effect of Failure To Pay Fees.--An abbreviated application
for a generic new animal drug 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 submission for a generic new animal
drug 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 abbreviated application for a
generic new animal drug, supplemental abbreviated application for a
generic new animal drug, or investigational submission for a generic
new animal drug 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
2008 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 abbreviated applications, generic new animal drug
sponsors, and generic new 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 abbreviated
applications for generic new animal drugs.
``(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 abbreviated applications for generic
new animal drugs (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 2008 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 abbreviated applications for generic new
animal drugs--
``(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) $4,831,000 for fiscal year 2009;
``(B) $5,106,000 for fiscal year 2010;
``(C) $5,397,000 for fiscal year 2011;
``(D) $5,706,000 for fiscal year 2012; and
``(E) $6,031,000 for fiscal year 2013;
as adjusted to reflect adjustments in the total fee revenues
made under this section and changes in the total amounts
collected by abbreviated application fees, generic new animal
drug sponsor fees, and generic new animal drug product fees.
``(4) Offset.--If the sum of the cumulative amount of fees
collected under this section for the fiscal years 2009 through
2011 and the amount of fees estimated to be collected under
this section for fiscal year 2012 exceeds the cumulative amount
appropriated under paragraph (3) for the fiscal years 2009
through 2012, the excess amount shall be credited to the
appropriation account of the Food and Drug Administration as
provided in paragraph (1), and shall be subtracted from the
amount of fees that would otherwise be authorized to be
collected under this section pursuant to appropriation Acts for
fiscal year 2013.
``(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 abbreviated
applications for generic new animal drugs, be reduced to offset the
number of officers, employees, and advisory committees so engaged.
``(k) Definitions.--In this section and section 742:
``(1) Abbreviated application for a generic new animal
drug.--The terms `abbreviated application for a generic new
animal drug' and `abbreviated application' mean an abbreviated
application for the approval of any generic new animal drug
submitted under section 512(b)(2). Such term does not include a
supplemental abbreviated application for a generic new animal
drug.
``(2) Adjustment factor.--The term `adjustment factor'
applicable to a fiscal year is the Consumer Price Index for all
urban consumers (all items; United States city average) for
October of the preceding fiscal year divided by--
``(A) for purposes of subsection (f)(1), such Index
for October 2002; and
``(B) for purposes of subsection (g)(2)(A)(ii),
such Index for October 2007.
``(3) Costs of resources allocated for the process for the
review of abbreviated applications for generic new animal
drugs.--The term `costs of resources allocated for the process
for the review of abbreviated applications for generic new
animal drugs' means the expenses incurred in connection with
the process for the review of abbreviated applications for
generic new animal drugs 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 abbreviated
applications, supplemental abbreviated applications, or
investigational 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 this section and
accounting for resources allocated for the review of
abbreviated applications, supplemental abbreviated
applications, and investigational submissions.
``(4) Final dosage form.--The term `final dosage form'
means, with respect to a generic new animal drug product, a
finished dosage form which is approved for administration to an
animal without substantial further manufacturing. Such term
includes generic new animal drug products intended for mixing
in animal feeds.
``(5) Generic new animal drug.--The term `generic new
animal drug' means a new animal drug that is the subject of an
abbreviated application.
``(6) Generic new animal drug product.--The term `generic
new 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 abbreviated application for a generic new animal drug
or a supplemental abbreviated application has been approved.
``(7) Generic new animal drug sponsor.--The term `generic
new animal drug sponsor' means either an applicant named in an
abbreviated application for a generic new animal drug that has
not been withdrawn by the applicant and for which approval has
not been withdrawn by the Secretary, or a person who has
submitted an investigational submission for a generic new
animal drug that has not been terminated or otherwise rendered
inactive by the Secretary.
``(8) Investigational submission for a generic new animal
drug.--The terms `investigational submission for a generic new
animal drug' and `investigational submission' mean--
``(A) the filing of a claim for an investigational
exemption under section 512(j) for a generic new animal
drug intended to be the subject of an abbreviated
application or a supplemental abbreviated application;
or
``(B) the submission of information for the purpose
of enabling the Secretary to evaluate the safety or
effectiveness of a generic new animal drug in the event
of the filing of an abbreviated application or
supplemental abbreviated application for such drug.
``(9) Person.--The term `person' includes an affiliate
thereof (as such term is defined in section 735(11)).
``(10) Process for the review of abbreviated applications
for generic new animal drugs.--The term `process for the review
of abbreviated applications for generic new animal drugs' means
the following activities of the Secretary with respect to the
review of abbreviated applications, supplemental abbreviated
applications, and investigational submissions:
``(A) The activities necessary for the review of
abbreviated applications, supplemental abbreviated
applications, and investigational submissions.
``(B) The issuance of action letters which approve
abbreviated applications or supplemental abbreviated
applications or which set forth in detail the specific
deficiencies in abbreviated applications, supplemental
abbreviated applications, or investigational
submissions and, where appropriate, the actions
necessary to place such applications, supplemental
applications, or submissions in condition for approval.
``(C) The inspection of generic new animal drug
establishments and other facilities undertaken as part
of the Secretary's review of pending abbreviated
applications, supplemental abbreviated applications,
and investigational submissions.
``(D) Monitoring of research conducted in
connection with the review of abbreviated applications,
supplemental abbreviated applications, and
investigational submissions.
``(E) The development of regulations and policy
related to the review of abbreviated applications,
supplemental abbreviated applications, and
investigational submissions.
``(F) Development of standards for products subject
to review.
``(G) Meetings between the agency and the generic
new animal drug sponsor.
``(H) Review of advertising and labeling prior to
approval of an abbreviated application or supplemental
abbreviated application, but not after such application
has been approved.
``(11) Supplemental abbreviated application for generic new
animal drug.--The terms `supplemental abbreviated application
for a generic new animal drug' and `supplemental abbreviated
application' mean a request to the Secretary to approve a
change in an approved abbreviated application.''.
SEC. 4. ACCOUNTABILITY AND REPORTS.
Part 5 of subchapter C of chapter VII of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379f et seq.), as added by section 3, is
amended by inserting after section 741 the following:
``SEC. 742. REAUTHORIZATION; REPORTING REQUIREMENTS.
``(a) Performance Reports.--Beginning with fiscal year 2009, not
later than 60 days after the end of each fiscal year during which fees
are collected under this part, the Secretary shall prepare and submit
to the Committee on Health, Education, Labor, and Pensions of the
Senate, and the Committee on Energy and Commerce of the House of
Representatives a report concerning the progress of the Food and Drug
Administration in achieving the goals identified in the letters
described in section 2(3) of the Animal Generic Drug User Fee Act of
2008 toward expediting the generic new animal drug development process
and the review of abbreviated applications for generic new animal
drugs, supplemental abbreviated applications for generic new animal
drugs, and investigational submissions for generic new animal drugs
during such fiscal year.
``(b) Fiscal Report.--Beginning with fiscal year 2009, not later
than 120 days after the end of each fiscal year during which fees are
collected under this part, the Secretary shall prepare and submit to
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives a
report on the implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration, of the
fees collected during such fiscal year for which the report is made.
``(c) Public Availability.--The Secretary shall make the reports
required under subsections (a) and (b) available to the public on the
Internet Web site of the Food and Drug Administration.
``(d) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to Congress with respect to the goals, and plans for
meeting the goals, for the process for the review of
abbreviated applications for generic new animal drugs for the
first 5 fiscal years after fiscal year 2013, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the
House of Representatives;
``(B) the Committee on Health, Education, Labor,
and Pensions of the Senate;
``(C) scientific and academic experts;
``(D) veterinary professionals;
``(E) representatives of patient and consumer
advocacy groups; and
``(F) the regulated industry.
``(2) Prior public input.--Prior to beginning negotiations
with the regulated industry on the reauthorization of this
part, the Secretary shall--
``(A) publish a notice in the Federal Register
requesting public input on the reauthorization;
``(B) hold a public meeting at which the public may
present its views on the reauthorization, including
specific suggestions for changes to the goals referred
to in subsection (a);
``(C) provide a period of 30 days after the public
meeting to obtain written comments from the public
suggesting changes to this part; and
``(D) publish the comments on the Food and Drug
Administration's Internet Web site.
``(3) Periodic consultation.--Not less frequently than once
every 4 months during negotiations with the regulated industry,
the Secretary shall hold discussions with representatives of
veterinary, patient, and consumer advocacy groups to continue
discussions of their views on the reauthorization and their
suggestions for changes to this part as expressed under
paragraph (2).
``(4) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under
paragraph (1) to the congressional committees specified
in such paragraph;
``(B) publish such recommendations in the Federal
Register;
``(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
``(D) hold a meeting at which the public may
present its views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(5) Transmittal of recommendations.--Not later than
January 15, 2013, the Secretary shall transmit to Congress the
revised recommendations under paragraph (4), a summary of the
views and comments received under such paragraph, and any
changes made to the recommendations in response to such views
and comments.
``(6) Minutes of negotiation meetings.--
``(A) Public availability.--Before presenting the
recommendations developed under paragraphs (1) through
(5) to Congress, the Secretary shall make publicly
available, on the Internet Web site of the Food and
Drug Administration, minutes of all negotiation
meetings conducted under this subsection between the
Food and Drug Administration and the regulated
industry.
``(B) Content.--The minutes described under
subparagraph (A) shall summarize any substantive
proposal made by any party to the negotiations as well
as significant controversies or differences of opinion
during the negotiations and their resolution.''.
SEC. 5. SUNSET DATES.
(a) Authorization.--The amendments made by section 3 shall cease to
be effective October 1, 2013.
(b) Reporting Requirements.--The amendment made by section 4 shall
cease to be effective January 31, 2014.
Union Calendar No. 521
110th CONGRESS
2d Session
H. R. 6433
[Report No. 110-805]
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to establish a
program of fees relating to generic new animal drugs.
_______________________________________________________________________
July 30, 2008
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed