[House Report 110-805]
[From the U.S. Government Publishing Office]
110th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 110-805
======================================================================
ANIMAL GENERIC DRUG USER FEE ACT OF 2008
_______
July 30, 2008.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Dingell, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 6433]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was
referred the bill (H.R. 6433) to amend the Federal Food, Drug,
and Cosmetic Act to establish a program of fees relating to
generic new animal drugs, having considered the same, report
favorably thereon with an amendment and recommend that the bill
as amended do pass.
CONTENTS
Page
Amendment........................................................ 2
Purpose and Summary.............................................. 8
Background and Need for Legislation.............................. 8
Hearings......................................................... 9
Committee Consideration.......................................... 9
Committee Votes.................................................. 9
Committee Oversight Findings..................................... 10
Statement of General Performance Goals and Objectives............ 10
New Budget Authority, Entitlement Authority, and Tax Expenditures 10
Earmarks and Tax and Tariff Benefits............................. 10
Committee Cost Estimate.......................................... 10
Congressional Budget Office Estimate............................. 10
Federal Mandates Statement....................................... 13
Advisory Committee Statement..................................... 13
Constitutional Authority Statement............................... 13
Applicability to Legislative Branch.............................. 13
Section-by-Section Analysis of the Legislation................... 13
Changes in Existing Law Made by the Bill, as Reported............ 15
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
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.
Purpose and Summary
The purpose of H.R. 6433, the Animal Generic Drug User Fee
Act of 2008, is to establish a program of fees for the review
of generic animal drug submissions and to improve the
timeliness and predictability of the process for generic animal
drug submissions.
Background and Need for Legislation
H.R. 6433 would establish a program of fees relating to
generic new animal drugs. Using the Animal Drug User Fee Act of
2003 (ADUFA) as a model, the Animal Generic Drug User Fee Act
of 2008 (AGDUFA) would provide funding for increased review of
generic animal drug submissions, for training and development
of staff members, and for refining business processes and
developing policies to allow more efficient review of generic
animal drug submissions.
In Congressional testimony in June 2008, the Food and Drug
Administration (FDA) reported that in fiscal year 2007, the
average review time for generic animal drug submissions was 570
days and that there was a backlog of 446 of these submissions,
almost double the number in fiscal year (FY) 2000. Section
512(c)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
requires FDA to review and act on these submissions within 180
days of submission.
In order to alleviate this backlog, a user fee for generic
animal drug submissions is proposed, along with relevant
performance goals. Under the AGDUFA user-fee proposal, FDA
would agree to meet review performance goals to improve the
timeliness and predictability of the animal generic drug review
process. These performance goals are intended to achieve
progressive yearly improvements, shortening the time for FDA to
review and act on submissions with each fiscal year. By the
fifth and final year of the proposed user fees, FDA would agree
to review and act on 90 percent of the sentinel submission
types within specified timeframes. Currently, FDA's review of
generic animal drug submissions is funded entirely through
appropriations.
The AGDUFA proposal has many similarities to the proposal
for ADUFA II (H.R. 6432, the Animal Drug User Fee Amendments of
2008), such as comparable fee triggers, fee-setting
requirements, workload adjustments, and reporting requirements.
The major differences are that AGDUFA does not allow FDA to
collect establishment fees, and FDA may only waive or reduce
fees if the drug is intended for a minor use or minor species
indication. Also, similar to the ADUFA II proposal, the AGDUFA
proposal has fixed annual increases instead of the inflation
adjuster used for the original ADUFA.
AGDUFA authorizes the collection of fees for FY 2009 to
2013 in the following amounts: $4,831,000 for FY 2009;
$5,106,000 for FY 2010; $5,397,000 for FY 2011; $5,706,000 for
FY 2012; and $6,031,000 for FY 2013. Fees are included for
abbreviated applications, generic new animal drug products, and
generic new animal drug sponsors.
Hearings
On June 5, 2008, the Subcommittee on Health held a hearing
on ``Committee Prints on Administration Legislative Proposals
on the Animal Drug User Fee Act Amendments of 2008 and the
Animal Generic Drug User Fee Act of 2008.'' The Subcommittee
received testimony from Bernadette Dunham, D.V.M., Ph.D.,
Director, Center for Veterinary Medicine, Food and Drug
Administration. Dr. Dunham was accompanied by Steven Vaughn,
D.V.M., Director, Office of New Animal Drug Evaluation, and
David Wardrop, Jr., Director, Office of Management. The
Subcommittee also received testimony from Richard A. Carnevale,
V.M.D., Vice President of Regulatory, Scientific, and
International Affairs, Animal Health Institute; Ms. Stephanie
Batliner, Chairperson, Generic Animal Drug Alliance, Director,
Pre-Market Regulatory Affairs, IVX Animal Health, Inc.; and Mr.
Robert Martin, Executive Director, Pew Commission on Industrial
Farm Animal Production.
Committee Consideration
On Wednesday, July 9, 2008, the Subcommittee on Health met
in open markup session and favorably forwarded H.R. 6433 to the
full Committee for consideration, by a voice vote. On
Wednesday, July 16, 2008, the full Committee met in open markup
session and ordered H.R. 6433 favorably reported to the House,
amended, by a voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto. No
record votes were taken on amendments or in connection with
ordering H.R. 6433 reported to the House. A motion by Mr.
Dingell to order H.R. 6433 favorably reported to the House,
amended, was agreed to by a voice vote.
Committee Oversight Findings
Regarding clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the oversight findings of the
Committee regarding H.R. 6433 are reflected in this report.
Statement of General Performance Goals and Objectives
The objectives of H.R. 6433 are to improve the timeliness
and predictability of the review process for generic animal
drug submissions and to improve the timeliness and
predictability of the process for generic animal drug
submissions.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Regarding compliance with clause 3(c)(2) of rule XIII of
the Rules of the House of Representatives, the Committee finds
that H.R. 6433 would result in no new or increased budget
authority, entitlement authority, or tax expenditures or
revenues.
Earmarks and Tax and Tariff Benefits
Regarding compliance with clause 9 of rule XXI of the Rules
of the House of Representatives, H.R. 6433 does not contain any
congressional earmarks, limited tax benefits, or limited tariff
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.
Committee Cost Estimate
The Committee adopts as its own the cost estimate on H.R.
6433 prepared by the Director of the Congressional Budget
Office pursuant to section 402 of the Congressional Budget Act
of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate on
H.R. 6433 provided by the Congressional Budget Office pursuant
to section 402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, July 28, 2008.
Hon. John D. Dingell,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 6433, the Animal
Generic Drug User Fee Act of 2008.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Julia
Christensen.
Sincerely,
Robert A. Sunshine
(For Peter R. Orszag, Director).
Enclosure.
H.R. 6433 Animal Generic Drug User Fee Act of 2008
Summary: H.R. 6433 would amend the Federal Food, Drug, and
Cosmetic Act to authorize the Food and Drug Administration
(FDA) to collect fees to cover the cost for certain activities
to expedite the development and marketing of generic new drugs
for use in animals. Fees would supplement appropriated funds to
cover FDA's cost associated with reviewing certain marketing
applications and investigational submissions for such drugs.
Those fees could be collected and made available for obligation
only to the extent and in the amounts provided in advance in
appropriation acts.
CBO estimates that implementing H.R. 6433 would reduce
discretionary outlays, on net, by $1 million over the 2009-2013
period, assuming the necessary authorities are provided in
appropriation acts. Enacting the bill would not affect direct
spending or revenues.
H.R. 6433 contains no intergovernmental mandates as defined
in the Unfunded Mandates Reform Act (UMRA).
The bill's requirement that sponsors of generic new drugs
for use in animals to pay certain fees to FDA would be a
private-sector mandate as defined in UMRA. However, CBO
estimates that the direct cost of complying with this
requirement would not exceed the annual thresholds established
by UMRA for private-sector mandates ($136 million in 2008,
adjusted annually for inflation).
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 6433 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
--------------------------------------------------
2009 2010 2011 2012 2013 2009-2013
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Food and Drug Administration (FDA):
Collection of User Fees:
Estimated Authorization Level........................ -5 -5 -5 -6 -8 -29
Estimated Outlays.................................... -5 -5 -5 -6 -8 -29
Spending of User Fees:
Estimated Authorization Level........................ 5 5 5 6 8 29
Estimated Outlays.................................... 3 6 6 6 6 27
Administrative Expenses:
Estimated Authorization Level........................ * * * * * 1
Estimated Outlays.................................... * * * * * 1
Net Effect on Spending by FDA:
Estimated Authorization Level.................... * * * * * 1
Estimated Outlays................................ -2 1 * * -1 -1
----------------------------------------------------------------------------------------------------------------
Note: * = less than $500,000. Components may not sum to totals because of rounding.
Basis of estimate: For this estimate, CBO assumes that H.R.
6433 will be enacted near the start of fiscal year 2009, that
the full amounts authorized will be collected and appropriated
for each year, and that outlays will follow historical patterns
for similar activities. Assuming appropriation action
consistent with the bill, CBO estimates that implementing H.R.
6433 would reduce discretionary outlays, on net, by $1 million
over the 2009-2013 period, primarily because the spending of
authorized fees slightly lags behind their collection.
User fees for generic new drugs for use in animals
H.R. 6433 would establish a new user fee program to help
defray FDA's costs of expediting and improving the regulatory
review process for generic new drugs for use in animals. It
would require FDA to assess and collect application and other
user fees from manufacturers of generic new drugs for use in
animals to expedite the development of such drugs and the
review of new and supplemental abbreviated applications and
investigational submissions for such products.
The bill would create three categories of user fees: (1)
abbreviated application fees, (2) fees on generic new drug
products for animals, and (3) fees on sponsors of generic new
drugs for animals. The aggregate amounts of such fees are
specified for each of fiscal years 2009 through 2013. Each
year, the amounts to be collected could be adjusted further for
workload estimates, when applicable. For fiscal year 2013, the
bill also would authorize the assessment and collection of up
to three months of operating reserves for the first three
months of fiscal year 2014.
Fees authorized by H.R. 6433 could be collected and made
available for obligation only to the extent and in the amounts
provided in advance in appropriation acts. In total, we
estimate that aggregate collections from fees authorized by the
bill would amount to $29 million over the 2009-2013 period,
assuming the necessary appropriation action.
Under the bill, user fees could not be assessed in a given
year unless appropriations for salaries and expenses of FDA
(excluding the amount of user fees appropriated for such fiscal
year) in that year satisfy a maintenance-of-effort requirement.
The user fees could be assessed if the amount appropriated
exceeded the amount appropriated for 2003 increased by an
adjustment factor that reflects the percentage increase in the
consumer price index for all urban consumers. In addition, fees
could be collected and made available to defray increases in
the cost of resources allocated to reviewing abbreviated
applications for generic new drugs for use in animals only to
the extent that the percentage increase in those costs
(excluding fees) exceeds the costs for fiscal year 2003
adjusted by the adjustment factor. This estimate assumes that
such conditions would be met.
Before accounting for costs associated with additional
administrative activities not covered by the user fees, CBO
estimates that establishing the user fee program would reduce
discretionary outlays, on net, by $2 million over the 2009-2013
period, assuming appropriation action consistent with the bill.
The estimated authorization levels for collections and spending
offset each other exactly from 2009 through 2013; however,
spending of authorized fees lags somewhat behind their
collection, thereby generating net savings over the period. In
addition, the amounts available for obligation and spending for
fiscal year 2013 would not include special reserve funds
collected in that year. That difference would result in savings
of almost $2 million for fiscal year 2013, CBO estimates.
Other administrative expenses
Funding for certain administrative activities associated
with the new user fee program would not be fully covered by
fees. The bill would require that FDA report annually to the
Congress on its performance under the user fee program and on
the fiscal status of the program. H.R. 6433 would require that
FDA consult with the Congressional committees of jurisdiction
and outside experts, including industry and consumer groups,
and publish its recommendations concerning reauthorization of
the user fee program on a specified schedule. CBO estimates
that the administrative activities associated with implementing
the user fee program that are not covered by the user fees
would cost less than $500,000 annually.
Estimated impact on state, local, and tribal governments:
H.R. 6433 contains no intergovernmental mandates as defined in
UMRA.
Estimated impact on the private sector: H.R. 6433 would
establish a user fee program at FDA for sponsors of generic
drugs intended for use in animals. The imposition of
application, product, and sponsor fees that private entities
would pay to FDA would be considered a private-sector mandate
as defined in UMRA. CBO estimates that the fees collected over
the 2009-2013 period would total $29 million. Those amounts
would not exceed the annual threshold specified in UMRA ($136
million in 2008, adjusted annually for inflation) in any of the
five years that the mandates would be effective.
Estimate prepared by: Federal Costs: Julia Christensen;
Impact on State, Local, and Tribal Governments: Lisa Ramirez-
Branum; Impact on the Private Sector: Paul Jacobs.
Estimate approved by: Keith J. Fontenot; Deputy Assistant
Director for Health and Human Resources, Budget Analysis
Division.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates regarding H.R. 6433 prepared by the Director of the
Congressional Budget Office pursuant to section 423 of the
Unfunded Mandates Reform Act.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act would be created by H.R.
6433.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for H.R. 6433 is provided in Article
I, section 8, clause 3, which grants Congress the power to
regulate commerce with foreign nations, among the several
States, and with the Indian Tribes.
Applicability to Legislative Branch
The Committee finds that H.R. 6433 does not relate to the
terms and conditions of employment or access to public services
or accommodations within the meaning of section 102(b)(3) of
the Congressional Accountability Act of 1995.
Section-by-Section Analysis of the Legislation
Section 1. Short title
This section establishes the short title of the legislation
as the ``Animal Generic Drug User Fee Act of 2008''.
Section 2. Findings
This section presents findings of Congress that making
additional funds available through user fees for the review of
abbreviated applications for generic new animal drugs would
serve animal and public health by facilitating prompt review of
safe and effective animal drugs.
These congressional findings also state that user fees
authorized under the legislation will be used to expedite the
process for generic drug development and for reviewing
abbreviated applications for generic new animal drugs.
Section 3. Fees relating to abbreviated applications for generic new
animal drugs
This section would amend the Federal Food, Drug, and
Cosmetic Act (FFDCA) to add authority for the FDA to collect
user fees for abbreviated applications, including: applicable
definitions for the various types of abbreviated applications
and submissions, as well as other terms to be used in the user-
fee program; provision for abbreviated application, product,
and sponsor fees; the total fee revenues to be collected for
each fee type for fiscal years 2009 through 2013 with
adjustments (used as the basis for determining fee amounts);
provision for fee waivers or reductions and collection of
unpaid fees; the annual user-fee trigger requires, exclusive of
user-fee appropriations, that FDA salaries and expenses
appropriations for such fiscal year equal or exceed such
appropriations for fiscal year 2003 multiplied by the
applicable adjustment factor; provisions governing the
crediting and availability of fees; and authorization of
appropriations for fees for each of fiscal years 2009 through
2013.
Section 4. Accountability and reports
This section states that the Secretary of Health and Human
Services (HHS) shall consult with the Committee on Energy and
Commerce and the Committee on Health, Education, Labor, and
Pensions (HELP), scientific and academic experts, veterinary
professionals, representatives of patient and consumer advocacy
groups, and the regulated industry in developing
recommendations to present to Congress regarding goals for
abbreviated applications for generic new animal drugs after
fiscal year 2013 and for reauthorizing the user fee program.
This section requires the Secretary of HHS to submit a
performance report and fiscal report to the Committee on Energy
and Commerce and the Committee on HELP each fiscal year. The
performance report will discuss the progress of FDA in
achieving the goals of the user-fee program as identified in a
letter from the Secretary of HHS to Congress. The fiscal report
will also discuss the implementation of the authority to
collect user fees and FDA's use of such fees during that year.
These reports shall be made publicly available through FDA's
Web site.
The Secretary is further directed to develop the
reauthorization proposal for AGDUFA in consultation with its
stakeholders, including representatives from consumer advocacy
and patient groups, veterinary professionals, and the regulated
industry.
Section 5. Sunset
This section states that authority for user fees will
expire October 1, 2013, and that the reporting provisions will
expire 120 days after that date.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER VII--GENERAL AUTHORITY
* * * * * * *
Subchapter C--Fees
* * * * * * *
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. 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.
Subchapter D--Information and Education
SEC. [741.] 745. INFORMATION SYSTEM.
The Secretary shall establish and maintain an information
system to track the status and progress of each application or
submission (including a petition, notification, or other
similar form of request) submitted to the Food and Drug
Administration requesting agency action.
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SEC. [742.] 746. EDUCATION.
(a) * * *
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Subchapter E--Environmental Impact Review
SEC. [746.] 749. ENVIRONMENTAL IMPACT.
Notwithstanding any other provision of law, an environmental
impact statement prepared in accordance with the regulations
published in part 25 of title 21, Code of Federal Regulations
(as in effect on August 31, 1997) in connection with an action
carried out under (or a recommendation or report relating to)
this Act, shall be considered to meet the requirements for a
detailed statement under section 102(2)(C) of the National
Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)).
* * * * * * *