[House Report 110-804]
[From the U.S. Government Publishing Office]
110th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 110-804
======================================================================
ANIMAL DRUG USER FEE AMENDMENTS 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. 6432]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 6432) to amend the Federal Food, Drug, and
Cosmetic Act to revise and extend the animal drug user fee
program, and for other purposes, having considered the same,
report favorably thereon with an amendment and recommend that
the bill as amended do pass.
CONTENTS
Page
Amendment........................................................ 1
Purpose and Summary.............................................. 5
Background and Need for Legislation.............................. 6
Hearings......................................................... 6
Committee Consideration.......................................... 6
Committee Votes.................................................. 7
Committee Oversight Findings..................................... 7
Statement of General Performance Goals and Objectives............ 7
New Budget Authority, Entitlement Authority, and Tax Expenditures 7
Earmarks and Tax and Tariff Benefits............................. 7
Committee Cost Estimate.......................................... 7
Congressional Budget Office Estimate............................. 7
Federal Mandates Statement....................................... 11
Advisory Committee Statement..................................... 11
Constitutional Authority Statement............................... 11
Applicability to Legislative Branch.............................. 11
Section-by-Section Analysis of the Legislation................... 11
Changes in Existing Law Made by the Bill, as Reported............ 16
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE; REFERENCES; FINDING.
(a) Short Title.--This Act may be cited as the ``Animal Drug User Fee
Amendments 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.).
(c) Finding.--Congress finds that the fees authorized by the
amendments made in this Act will be dedicated toward expediting the
animal drug development process and the review of new and supplemental
animal drug applications and investigational animal drug submissions as
set forth in the goals identified, for purposes of part 4 of subchapter
C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the
letters from the Secretary of Health and Human Services to the Chairman
of the Committee on Energy and Commerce of the House of Representatives
and the Chairman of the Committee on Health, Education, Labor, and
Pensions of the Senate as set forth in the Congressional Record.
SEC. 2. DEFINITIONS.
Section 739 (21 U.S.C. 379j-11) is amended--
(1) in paragraph (6), by striking ``, except for an approved
application for which all subject products have been removed
from listing under section 510'' and inserting ``that has not
been withdrawn by the applicant and for which approval has not
been withdrawn by the Secretary'';
(2) in paragraph (8)(H), by striking ``but not such
activities after an animal drug has been approved'' and
inserting ``but not after such application has been approved'';
(3) in paragraph (10), by striking ``year being 2003'' and
inserting ``month being October 2002'';
(4) by redesignating paragraph (11) as paragraph (12); and
(5) by inserting after paragraph (10) the following:
``(11) The term `person' includes an affiliate thereof.''.
SEC. 3. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
(a) Types of Fees.--Section 740(a) (21 U.S.C. 379j-12(a)) is
amended--
(1) in paragraph (1)(A)(i), by inserting after ``for an
animal drug application'' the following: ``, except an animal
drug application subject to the criteria set forth in section
512(d)(4)''; and
(2) by amending paragraph (1)(A)(ii) to read as follows:
``(ii) A fee established in subsection (b),
in an amount that is equal to 50 percent of the
amount of the fee under clause (i), for--
``(I) a supplemental animal drug
application for which safety or
effectiveness data are required; and
``(II) an animal drug application
subject to the criteria set forth in
section 512(d)(4).''.
(b) Fee Amounts.--
(1) Total fee revenues for application and supplement fees.--
Section 740(b)(1) (21 U.S.C. 379j-12(b)(1)) is amended--
(A) by striking ``and supplemental animal drug
application fees'' and inserting ``and supplemental and
other animal drug application fees''; and
(B) by striking ``$1,250,000'' and all that follows
through the period at the end and inserting
``$3,815,000 for fiscal year 2009, $4,320,000 for
fiscal year 2010, $4,862,000 for fiscal year 2011,
$5,442,000 for fiscal year 2012, and $6,061,000 for
fiscal year 2013.''.
(2) Total fee revenues for product fees.--Section 740(b)(2)
(21 U.S.C. 379j-12(b)(2)) is amended by striking ``$1,250,000''
and all that follows through the period at the end and
inserting ``$3,815,000 for fiscal year 2009, $4,320,000 for
fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000
for fiscal year 2012, and $6,061,000 for fiscal year 2013.''.
(3) Total fee revenues for establishment fees.--Section
740(b)(3) (21 U.S.C. 379j-12(b)(3)) is amended by striking
``$1,250,000'' and all that follows through the period at the
end and inserting ``$3,815,000 for fiscal year 2009, $4,320,000
for fiscal year 2010, $4,862,000 for fiscal year 2011,
$5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year
2013.''.
(4) Total fee revenues for sponsor fees.--Section 740(b)(4)
(21 U.S.C. 379j-12(b)(4)) is amended by striking ``$1,250,000''
and all that follows through the period at the end and
inserting ``$3,815,000 for fiscal year 2009, $4,320,000 for
fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000
for fiscal year 2012, and $6,061,000 for fiscal year 2013.''.
(c) Adjustments to Fees.--Section 740(c) (21 U.S.C. 379j-12(c)) is
amended--
(1) by striking paragraph (1);
(2) by redesignating paragraphs (2) through (5) as paragraphs
(1) through (4), respectively;
(3) in paragraph (1), as so redesignated--
(A) in the matter preceding subparagraph (A), by
striking ``After the fee revenues are adjusted for
inflation in accordance with paragraph (1), the fee
revenues shall be further adjusted each fiscal year
after fiscal year 2004'' and inserting ``The fee
revenues shall be adjusted each fiscal year after
fiscal year 2009''; and
(B) in subparagraph (B), by striking ``, as adjusted
for inflation under paragraph (1)''; and
(4) in paragraph (2), as so redesignated--
(A) by striking ``2008'' each place it appears and
inserting ``2013''; and
(B) by striking ``2009'' and inserting ``2014''.
(d) Authorization of Appropriations.--Subparagraphs (A) through (E)
of section 740(g)(3) (21 U.S.C. 379j-12(g)(3)) are amended to read as
follows:
``(A) $15,260,000 for fiscal year 2009;
``(B) $17,280,000 for fiscal year 2010;
``(C) $19,448,000 for fiscal year 2011;
``(D) $21,768,000 for fiscal year 2012; and
``(E) $24,244,000 for fiscal year 2013;''.
(e) Offset.--Section 740(g)(4) (21 U.S.C. 379j-12(g)(4)) is amended
to read as follows:
``(4) Offset.--If the sum of the cumulative amount of fees
collected under this section for 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.''.
SEC. 4. REAUTHORIZATION; REPORTING REQUIREMENTS.
Part 4 of subchapter C of chapter VII (21 U.S.C. 379j-11 et seq.) is
amended by inserting after section 740 the following:
``SEC. 740A. REAUTHORIZATION; REPORTING REQUIREMENTS.
``(a) Performance Report.--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 Energy and Commerce of the House of Representatives
and the Committee on Health, Education, Labor, and Pensions of the
Senate a report concerning the progress of the Food and Drug
Administration in achieving the goals identified in the letters
described in section 1(c) of the Animal Drug User Fee Amendments of
2008 toward expediting the animal drug development process and the
review of the new and supplemental animal drug applications and
investigational animal drug submissions during such fiscal year, the
future plans of the Food and Drug Administration for meeting the goals,
the review times for abbreviated new animal drug applications, and the
administrative procedures adopted by the Food and Drug Administration
to ensure that review times for abbreviated new animal drug
applications are not increased from their current level due to
activities under the user fee program.
``(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
the Committee on Energy and Commerce of the House of Representatives
and the Committee on Health, Education, Labor, and Pensions of the
Senate a report on the implementation of the authority for such fees
during such fiscal year and the use, by the Food and Drug
Administration, of the fees collected during such fiscal year for which
the report is made.
``(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 the Congress with respect to the goals, and plans for
meeting the goals, for the process for the review of animal
drug applications 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 the 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 the 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. ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION REPORTS.
(a) Reports.--Section 512(l) (21 U.S.C. 360b(l)) is amended by adding
at the end the following:
``(3)(A) In the case of each new animal drug described in paragraph
(1) that contains an antimicrobial active ingredient, the sponsor of
the drug shall submit an annual report to the Secretary on the amount
of each antimicrobial active ingredient in the drug that is sold or
distributed for use in food-producing animals, including information on
any distributor-labeled product.
``(B) Each report under this paragraph shall specify the amount of
each antimicrobial active ingredient--
``(i) by container size, strength, and dosage form;
``(ii) by quantities distributed domestically and quantities
exported; and
``(iii) by dosage form, including, for each such dosage form,
a listing of the target animals, indications, and production
classes that are specified on the approved label of the
product.
``(C) Each report under this paragraph shall--
``(i) be submitted not later than March 31 each year;
``(ii) cover the period of the preceding calendar year; and
``(iii) include separate information for each month of such
calendar year.
``(D) The Secretary may share information reported under this
paragraph with the Antimicrobial Resistance Task Force established
under section 319E of the Public Health Service Act.
``(E) The Secretary shall make summaries of the information reported
under this paragraph publicly available, except that--
``(i) the summary data shall be reported by antimicrobial
class, and no class with fewer than 3 distinct sponsors of
approved applications shall be independently reported; and
``(ii) the data shall be reported in a manner consistent with
protecting both national security and confidential business
information.''.
(b) First Report.--For each new animal drug that is subject to the
reporting requirement under section 512(l)(3) of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a), and for which an
approval of an application filed pursuant to section 512(b) or 571 of
such Act is in effect on the date of the enactment of this Act, the
Secretary of Health and Human Services shall require the sponsor of the
drug to submit the first report under such section 512(l)(3) for the
drug not later than March 31, 2010.
(c) Separate Report.--The reports required under section 512(l)(3) of
the Federal Food, Drug, and Cosmetic Act, as added by subsection (a),
shall be separate from periodic drug experience reports that are
required under section 514.80(b)(4) of title 21, Code of Federal
Regulations (as in effect on the date of the enactment of this Act).
SEC. 6. DESTRUCTION OF COUNTERFEIT ANIMAL DRUGS OFFERED FOR IMPORT.
Section 801(a) (21 U.S.C. 381(a)) is amended--
(1) in the third sentence, by inserting ``or (4) such article
is a counterfeit drug intended for use for animals other than
man,'' before ``then such article shall be refused admission'';
and
(2) by striking ``Clause (2) of the third sentence of this
paragraph'' and inserting ``Notwithstanding the preceding
sentence, the Secretary of the Treasury shall cause the
destruction of any such article refused admission if (1) the
article is a drug intended for use for animals other than man,
the article appears to be adulterated, misbranded, or in
violation of section 505, and the article has a value less than
$2,000 or such amount as the Secretary of Health and Human
Services may determine by regulation; or (2) the article
appears to be a counterfeit drug intended for use for animals
other than man. Clause (2) of the third sentence of this
subsection''.
SEC. 7. SAVINGS CLAUSE.
Notwithstanding section 5 of the Animal Drug User Fee Act of 2003 (21
U.S.C. 379j-11 note), and notwithstanding the amendments made by this
Act, part 4 of subchapter C of chapter VII of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-11 et seq.), as in effect on the day
before the date of the enactment of this Act, shall continue to be in
effect with respect to animal drug applications and supplemental animal
drug applications (as defined in such part as of such day) that on or
after September 1, 2003, but before October 1, 2008, were accepted by
the Food and Drug Administration for filing with respect to assessing
and collecting any fee required by such part for a fiscal year prior to
fiscal year 2009.
SEC. 8. EFFECTIVE DATE.
The amendments made by sections 2, 3, and 4 shall take effect on
October 1, 2008, and fees under part 4 of subchapter C of chapter VII
of the Federal Food, Drug, and Cosmetic Act, as amended by this Act,
shall be assessed for all animal drug applications and supplemental
animal drug applications received on or after such date, regardless of
the date of the enactment of this Act.
SEC. 9. SUNSET DATES.
(a) Authorization.--The amendments made by sections 2 and 3 cease to
be effective October 1, 2013.
(b) Reporting Requirements.--The amendment made by section 4 ceases
to be effective January 31, 2014.
Purpose and Summary
H.R. 6432, the Animal Drug User Fee Amendments of 2008,
amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to
revise and extend the animal drug user fee program, and for
other purposes.
Background and Need for Legislation
The Animal Drug User Fee Act of 2003 (ADUFA) established
the animal drug user fee program. The program provides an
additional revenue source for the Food and Drug Administration
(FDA) to supplement appropriations from Congress for the
purpose of expediting the review of animal drug applications.
Before ADUFA was enacted, there were reports from FDA detailing
inadequate resources for review, growing workloads, and low
quality applications submitted by the industry. These problems
combined were responsible for slowing down the animal drug
approval process to an unacceptable rate.
In response to these problems, ADUFA was enacted. The
program requires that manufacturers of new animal drugs pay
application fees for each new product, annual manufacturing
establishment fees, annual product fees, and sponsor fees in an
effort to expedite the animal drug review process. FDA sets
performance goals, mutually agreed upon by FDA and the
regulated industry. The fees are used to meet the performance
goals. The Secretary of Health and Human Services (HHS) is
required to send a letter identifying these goals to the
Chairman of the House Committee on Energy and Commerce and the
Chairman of the Senate Committee on Health, Education, Labor,
and Pensions (HELP), and this letter is included in the
Congressional Record. Fees currently represent about 13 percent
of the agency's budget for animal drug review and for 60 full-
time equivalent employees.
There is general agreement that ADUFA has been successful
in eliminating the review backlog and has improved the
timeliness and predictability of reviews. ADUFA expires on
October 1, 2008, prompting congressional action for its
reauthorization.
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. 6432 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. 6432 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. 6432 reported to the House. A motion by Mr.
Dingell to order H.R. 6432 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. 6432 are reflected in this report.
Statement of General Performance Goals and Objectives
The objective of H.R. 6432 is to reauthorize the animal
drug user fee program, which provides resources for expediting
the animal drug development process and the review of new and
supplemental animal drug applications and investigational
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. 6432 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. 6432 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.
6432 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. 6432 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. 6432, the Animal
Drug User Fee Amendments 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. 6432--Animal Drug User Fee Amendments of 2008
Summary: H.R. 6432 would authorize the collection and
spending of user fees by the Food and Drug Administration (FDA)
for certain activities to expedite the development and
marketing approval of drugs for use in animals. Fees would
supplement appropriated funds to cover FDA's cost associated
with reviewing certain applications and investigational
submissions for animal drugs. Such fees could be collected and
made available for obligation only to the extent and in the
amounts provided in advance in appropriation acts. The
legislation would extend through fiscal year 2013 and make
several technical changes to the existing user fee program for
animal drugs, which expires at the end of fiscal year 2008.
H.R. 6432 would also require sponsors of new animal drugs
to submit annual reports to FDA on certain products that
contain antimicrobial active ingredients, and it would require
FDA to make summaries of such information publicly available.
CBO estimates that implementing H.R. 6432 would reduce
discretionary outlays, on net, by $6 million over the 2009-2013
period, assuming the necessary authorities are provided in
appropriation acts. The bill would not affect direct spending
or revenues.
H.R. 6432 contains no intergovernmental mandates as defined
in the Unfunded Mandates Reform Act (UMRA).
The bill would impose private-sector mandates, as defined
in UMRA, because it would require manufacturers of drugs for
use in animals to pay specified fees to FDA and to submit
reports to the agency for certain products. CBO estimates that
the direct cost of complying with these requirements would not
exceed the annual threshold 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. 6432 is shown in the following table.
The costs of this legislation fall primarily 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....................... -15 -17 -19 -22 -27 -101
Estimated Outlays................................... -15 -17 -19 -22 -27 -101
Spending of User Fees:
Estimated Authorization Level....................... 15 17 19 22 27 101
Estimated Outlays................................... 11 17 19 22 24 93
Administrative Expenses:
Estimated Authorization Level....................... 1 * * * * 2
Estimated Outlays................................... 1 * * * * 2
Net Effect on Spending by FDA:
Estimated Authorization Level................... 1 * * * * 2
Estimated Outlays............................... -3 * * * -3 -6
----------------------------------------------------------------------------------------------------------------
Note: * = between -$500,000 and $500,000. Components may not sum to totals because of rounding.
Basis of estimate: For this estimate, CBO assumes that H.R.
6432 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 the program. Assuming appropriation action consistent with
the bill, CBO estimates that implementing H.R. 6432 would
reduce discretionary outlays, on net, by $6 million over the
2009-2013 period, primarily because the spending of authorized
fees lags slightly behind their collection.
User fees for animal drugs
H.R. 6432 would authorize FDA to assess and collect certain
fees from manufacturers of drugs for use in animals to help
defray FDA's costs of expediting the regulatory review process
for such drugs. Under current law, the user fee program for
animal drugs will expire at the end of fiscal year 2008.
Similar to the existing fee structure, four categories of
user fees would be authorized by the bill: (1) animal drug
application and supplement fees, (2) animal drug product fees,
(3) animal drug establishment fees, and (4) animal drug sponsor
fees. The bill would authorize the appropriation of specific
aggregate amounts of collections for each fiscal year 2009
through 2013. Collections could be modified each year based on
certain workload estimates, when applicable. The legislation
also would make several technical changes to the existing user
fee program.
Fees authorized by H.R. 6432 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
FDA would assess and collect the amounts specified in the bill
without any additional adjustment for workload. (No such
adjustments have occurred over the last 5 years of the existing
program and we expect that they would not occur in the future.)
For fiscal year 2013, the bill would authorize the assessment
and collection of up to three months of operating reserves for
the first three months of fiscal year 2014. In total, we
estimate aggregate collections from fees authorized by the bill
would amount to $101 million over the 2009-2013 period.
The legislation would retain the existing statutory
limitation that user fees cannot 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 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 animal drug applications 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 and
other activities required by the bill, CBO estimates that
authorizing the user fee program for the 2009-2013 period would
reduce discretionary outlays, on net, by $8 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 savings over the period. In
addition, amounts available for obligation and spending for
fiscal year 2013 would not include additional special reserve
funds collected in that year. CBO estimates that difference
would result in savings of $3 million for fiscal year 2013.
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. 6432 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. In addition, H.R.
6432 would also require sponsors of animal drugs to submit
annual reports to FDA on certain new products that contain
antimicrobial active ingredients, and it would require FDA to
make summaries of such information publicly available. CBO
estimates that the administrative activities associated with
implementing the user fee program that are not covered by the
user fees and other activities required by the bill would cost
between $1 million and $2 million over the 2009-2013 period.
Estimated impact on state, local, and tribal governments:
H.R. 6432 contains no intergovernmental mandates as defined in
UMRA.
Estimated impact on the private sector: H.R. 6432 would
require sponsors of drugs intended for use in animals to pay
application, product, establishment, and other related fees to
FDA. The bill also would require sponsors of new animal drugs
containing active antimicrobial ingredients to submit an annual
report to FDA regarding the amount of these ingredients and
additional information specified by the bill.
Both of these requirements would be considered private-
sector mandates as defined in UMRA. CBO estimates that the fees
collected over the 2009-2013 period would total $101 million.
CBO also estimates that the direct cost of complying with both
of these requirements 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. 6432 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.
6432.
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. 6432 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. 6432 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; references; finding
Section 1 designates the short title of the bill as the
``Animal Drug User Fee Amendments of 2008''; states that
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.);
and states that the fees authorized by this Act will be
dedicated toward expediting the animal drug development process
and the review of new and supplemental animal drug applications
and investigational animal drug submissions.
Section 2. Definitions
Section 2 amends three definitions found in section 739 of
the Federal Food, Drug, and Cosmetic Act (FFDCA). This section
modifies the definition of the term ``animal drug sponsor'' to
mean either an applicant named in an animal drug application
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 animal drug submission
that has not been terminated or otherwise rendered inactive by
the Secretary. This section also modifies the definition of the
term ``adjustment factor'' so that the base or comparator month
is October 2002. Finally, this section modifies the definition
of the term ``process for the review of animal drug
applications'' to clarify that FDA is allowed to use animal
drug user fees to review advertising and labeling for purposes
of a supplemental abbreviated application.
Additionally, section 2 includes a new term for ``person.''
The term ``person'' is defined to include an affiliate thereof.
Section 3. Authority to assess and use animal drug fees
Section 3 amends section 740(a) of the FFDCA. This section
states that each person that submits an animal drug application
shall be subject to application and supplement fees, product
fees, establishment fees, and sponsor fees unless the animal
drug application is subject to the criteria set forth in
section 512(d)(4). Additionally, this section clarifies that
each person that submits a supplemental animal drug
application, for which safety or effectiveness data are
required, or an animal drug application, subject to the
criteria set forth in section 512(d)(4), shall be subject to
application and supplement fees, product fees, establishment
fees, and sponsor fees. This fee amount shall equal 50 percent
of the amount of the fee for animal drug applications not
subject to section 512(d)(4).
Section 3 amends section 740(b) of the FFDCA. This section
increases total fee revenues for application and supplement
fees, product fees, establishment fees, and sponsor fees.
Section 3 amends section 740(c) of the FFDCA. This section
requires that fee revenues shall be adjusted each fiscal year
(FY) after FY 2009. In addition, this section modifies the
existing final year adjustment provision. For FY 2013, the
Secretary may further increase the fees to provide for up to
three months of operating reserves of carryover user fees for
the review of animal drug applications for the first three
months of FY 2014. If this adjustment is necessary, then the
rationale for the amount of the increase shall be contained in
the annual notice setting fees for FY 2013. This one-time
increase in fees in FY 2013, if necessary, assures that the
agency will have up to three months of operating reserves on
hand at the end of FY 2013, when this legislation will sunset.
Section 3 amends section 740(g)(3) of the FFDCA. This
section authorizes to be appropriated for fees under this
section: $15,260,000 for FY 2009; $17,280,000 for FY 2010;
$19,448,000 for FY 2011; $21,768,000 for FY 2012; and
$24,244,000 for FY 2013.
Section 3 amends section 740(g)(4) of the FFDCA. This
section clarifies that if the sum of the cumulative amount of
fees collected under this section for fiscal years 2009 through
2011 and the amount of fees estimated to be collected under
this section for FY 2012 exceeds the cumulative amount
appropriated under paragraph (3) for the fiscal years 2009
through 2012, the excess amount shall be credited to FDA's
appropriation account. It shall then be subtracted from the
amount of fees that would otherwise be authorized to be
collected under this section pursuant to Appropriation Acts for
FY 2013.
Section 4. Reauthorization; reporting requirements
New section 740A requires that, beginning with FY 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 a report to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
HELP of the Senate. This report shall discuss the progress of
FDA in achieving the goals of the Animal Drug User Fee
Amendments of 2008, as identified in a letter from the
Secretary of HHS to Congress. These goals include expediting
the animal drug development process and the review of the new
and supplemental animal drug applications and investigational
animal drug submissions during each fiscal year; the future
plans of FDA for meeting the goals; the review times for
abbreviated new animal drug applications; and the
administrative procedures adopted by FDA to ensure that review
times for abbreviated new animal drug applications are not
increased from their current level due to activities under the
user fee program.
New section 740A also requires that, beginning with FY
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 a report to the Committee on Energy
and Commerce of the House of Representatives and the Committee
on HELP of the Senate. The report must include information
about (1) whether each of the three funding triggers has been
met for each fiscal year; (2) total costs for the process of
review of animal drug applications, as defined in ADUFA I; and
(3) the amounts paid from user fee revenues and appropriations.
New section 740A requires that the Secretary make these
reports available to the public on FDA's Web site.
In addition, new section 740A requires that, in developing
recommendations to present to Congress with respect to the
goals, and plans for meeting the goals, for the review of
animal drug applications for the first five fiscal years after
FY 2013, and for the reauthorization of this part for such
fiscal years, the Secretary shall consult with the following:
the Committee on Energy and Commerce of the House of
Representatives; the Committee on HELP of the Senate;
scientific and academic experts; veterinary professionals;
representatives of patient and consumer advocacy groups; and
the regulated industry.
New section 740A states that, prior to beginning
negotiations with the regulated industry on the reauthorization
of this part, the Secretary shall publish a notice in the
Federal Register requesting public input on the
reauthorization; hold a public meeting at which the public may
present its views on the reauthorization, including specific
suggestions for changes to the goals; provide a period of 30
days after the public meeting to obtain written comments from
the public suggesting changes to this part; and publish the
comments on FDA's Web site.
New section 740A requires that, not less frequently than
once every four months during negotiations with the regulated
industry, the Secretary shall hold discussions with
representatives of veterinary, patient, and consumer advocacy
groups to solicit their views on the reauthorization and their
suggestions for changes to this part. This language is based on
the latest Prescription Drug User Fee Act (PDUFA)
reauthorization, which became Public Law 110-85 on September
27, 2007, and which requires monthly meetings between FDA and
patient and consumer groups during negotiations with the
regulated industry. This Act requires less frequent meeting
because, to date, fewer patient and consumer groups have
attended the ADUFA meetings than have attended the PDUFA
meetings. If, however, it becomes apparent that more
veterinary, patient, and consumer groups are interested in
participating in these discussions with FDA, it may be
appropriate for FDA to increase the frequency of these
discussions.
New section 740A requires that, after negotiation with the
regulated industry, the Secretary shall present the
recommendations to the Committee on Energy and Commerce of the
House of Representatives and the Committee on HELP of the
Senate; publish such recommendations in the Federal Register;
provide for a period of 30 days for the public to provide
written comments on such recommendations; hold a meeting at
which the public may present its views on such recommendations;
and after consideration of such public views and comments,
revise such recommendations as necessary. Not later than
January 15, 2013, the Secretary shall then transmit to Congress
the revised recommendations, a summary of the views and
comments received, and any changes made to the recommendations
in response to such views and comments.
New section 740A states that, prior to presenting
recommendations to Congress, the Secretary shall make publicly
available on FDA's Web site minutes of all negotiation meetings
conducted under this subsection between FDA and the regulated
industry. The minutes 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.
Section 5. Antimicrobial animal drug distribution reports
Section 5 amends section 512(l) of the FFDCA. This section
requires that for each new animal drug containing an
antimicrobial active ingredient, for which an approval of an
application filed pursuant to subsection (b) or section 571 is
in effect, the sponsor of the drug shall submit an annual
report to the Secretary on the amount of each antimicrobial
active ingredient in the drug that is sold or distributed for
use in food-producing animals, including information on any
distributor-labeled product. In analyzing this information, FDA
should take steps to avoid duplication of data that may result
from receiving both manufacturer-labeled and distributor-
labeled information for a single antimicrobial active
ingredient.
The Committee expects FDA to use information garnered from
these annual reports in its continuing analysis of the
interactions (including drug resistance), efficacy, and safety
of antibiotics approved for use in both humans and food-
producing animals.
Each report shall specify the amount of each antimicrobial
active ingredient by container size, strength, and dosage form;
by quantities distributed domestically and quantities exported;
and by dosage form, including, for each such dosage form, a
listing of the target animals, indications, and production
classes that are specified on the approved label of the
product. Each report shall be submitted not later than March 31
of each year, shall cover the period of the preceding calendar
year, and shall include separate information for each month of
such calendar year. There is precedent for monthly reporting as
evidenced by the monthly data collection on antibiotic
resistance that is gathered under the National Antimicrobial
Resistance Monitoring System (NARMS) operated cooperatively by
the Food and Drug Administration's Center for Veterinary
Medicine, U.S. Department of Agriculture, and the Centers for
Disease Control and Prevention.
The Secretary may share information reported under this
section with the Antimicrobial Resistance Task Force
established under section 319E of the Public Health Service
Act. As of the date of enactment of this Act, the Antimicrobial
Resistance Task Force was composed solely of representatives
from Federal agencies, as determined by the Secretary of Health
and Human Services. It is the intention of this Committee that
information reported under this section be available only to
representatives of Federal agencies. If the membership of the
Antimicrobial Resistance Task Force is ever expanded to include
representatives of non-Federal agencies, the appropriate steps
should be taken to ensure that representatives of non-Federal
agencies only receive information consistent with what is
provided publicly under this section.
The Secretary shall make summaries of the information
reported in this section publicly available. Summary data shall
be reported by antimicrobial class, and no class with fewer
than three distinct sponsors of approved applications shall be
independently reported. Data shall be reported in a manner
consistent with protecting both national security and
confidential business information.
This section requires that for each new animal drug that is
subject to this new reporting requirement, and for which an
approval of an application filed pursuant to section 512(b) or
571 of such Act is in effect on the date of the enactment of
this Act, the Secretary of HHS shall require the sponsor of the
drug to submit the first report for the drug no later than
March 31, 2010.
This section clarifies that the new reports required by
this section are separate from periodic drug experience reports
that are required under section 514.80(b)(4) of title 21, Code
of Federal Regulations (as in effect on the date of the
enactment of this Act).
Section 6. Destruction of counterfeit animal drugs offered for import
Section 6 amends section 801(a) of the FFDCA. This section
states that the Secretary of the Treasury may refuse to allow
the admission of a drug intended for use in animals into the
United States, if it is deemed to be a counterfeit. In
addition, this section requires the Secretary of Treasury to
cause the destruction of any animal drug refused for admission
if the drug (1) appears to be adulterated, misbranded, or in
violation of section 505 and the article has a value less than
$2,000, or such amount as the Secretary of HHS may determine by
regulation; or (2) the drug appears to be a counterfeit animal
drug.
Section 7. Savings clause
Section 7 states that, notwithstanding section 5 of the
Animal Drug User Fee Act of 2003 and notwithstanding the
amendments made by this Act, part 4 of subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act, as in effect
on the day before the date of the enactment of this Act, shall
continue to be in effect with respect to animal drug
applications and supplemental animal drug applications that on
or after September 1, 2003, but before October 1, 2008, were
accepted by FDA for filing with respect to assessing and
collecting any fee required by such part for a fiscal year
prior to FY 2009.
Section 8. Effective date
Section 8 states that the amendments made by sections 2, 3,
and 4 shall take effect on October 1, 2008, and the fees under
part 4 of subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act, as amended by this Act, shall be
assessed for all animal drug applications received on or after
such date, regardless of the date of the enactment of this Act.
Section 9. Sunset dates
Section 9 states that the amendments made by sections 2 and
3 cease to be effective on October 1, 2013. Section 8 further
states that section 4 ceases to be effective on January 31,
2014.
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 V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
* * * * * * *
NEW ANIMAL DRUGS
Sec. 512. (a) * * *
* * * * * * *
(l)(1) * * *
* * * * * * *
(3)(A) In the case of each new animal drug described in
paragraph (1) that contains an antimicrobial active ingredient,
the sponsor of the drug shall submit an annual report to the
Secretary on the amount of each antimicrobial active ingredient
in the drug that is sold or distributed for use in food-
producing animals, including information on any distributor-
labeled product.
(B) Each report under this paragraph shall specify the amount
of each antimicrobial active ingredient--
(i) by container size, strength, and dosage form;
(ii) by quantities distributed domestically and
quantities exported; and
(iii) by dosage form, including, for each such dosage
form, a listing of the target animals, indications, and
production classes that are specified on the approved
label of the product.
(C) Each report under this paragraph shall--
(i) be submitted not later than March 31 each year;
(ii) cover the period of the preceding calendar year;
and
(iii) include separate information for each month of
such calendar year.
(D) The Secretary may share information reported under this
paragraph with the Antimicrobial Resistance Task Force
established under section 319E of the Public Health Service
Act.
(E) The Secretary shall make summaries of the information
reported under this paragraph publicly available, except that--
(i) the summary data shall be reported by
antimicrobial class, and no class with fewer than 3
distinct sponsors of approved applications shall be
independently reported; and
(ii) the data shall be reported in a manner
consistent with protecting both national security and
confidential business information.
* * * * * * *
CHAPTER VII--GENERAL AUTHORITY
* * * * * * *
Subchapter C--Fees
* * * * * * *
PART 4--FEES RELATING TO ANIMAL DRUGS
SEC. 739. DEFINITIONS.
For purposes of this part:
(1) * * *
* * * * * * *
(6) The term ``animal drug sponsor'' means either an
applicant named in an animal drug application[, except
for an approved application for which all subject
products have been removed from listing under section
510] 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 animal drug submission that has not
been terminated or otherwise rendered inactive by the
Secretary.
* * * * * * *
(8) The term ``process for the review of animal drug
applications'' means the following activities of the
Secretary with respect to the review of animal drug
applications, supplemental animal drug applications,
and investigational animal drug submissions:
(A) * * *
* * * * * * *
(H) Review of advertising and labeling prior
to approval of an animal drug application or
supplemental animal drug application, [but not
such activities after an animal drug has been
approved] but not after such application has
been approved.
* * * * * * *
(10) The term ``adjustment factor'' applicable to a
fiscal year refers to the formula set forth in section
735(8) with the base or comparator [year being 2003]
month being October 2002.
(11) The term ``person'' includes an affiliate
thereof.
[(11)] (12) The term ``affiliate'' refers to the
definition set forth in section 735(11).
SEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
(a) Types of Fees.--Beginning in fiscal year 2004, the
Secretary shall assess and collect fees in accordance with this
section as follows:
(1) Animal drug application and supplement fee.--
(A) In general.--Each person that submits, on
or after September 1, 2003, an animal drug
application or a supplemental animal drug
application shall be subject to a fee as
follows:
(i) A fee established in subsection
(b) for an animal drug application,
except an animal drug application
subject to the criteria set forth in
section 512(d)(4); and
[(ii) A fee established in subsection
(b) for a supplemental animal drug
application for which safety or
effectiveness data are required, in an
amount that is equal to 50 percent of
the amount of the fee under clause
(i).]
(ii) A fee established in subsection
(b), in an amount that is equal to 50
percent of the amount of the fee under
clause (i), for--
(I) a supplemental animal
drug application for which
safety or effectiveness data
are required; and
(II) an animal drug
application subject to the
criteria set forth in section
512(d)(4).
* * * * * * *
(b) Fee Amounts.--Except as provided in subsection (a)(1) and
subsections (c), (d), (f), and (g), the fees required under
subsection (a) shall be established to generate fee revenue
amounts as follows:
(1) Total fee revenues for application and supplement
fees.--The total fee revenues to be collected in animal
drug application fees under subsection (a)(1)(A)(i)
[and supplemental animal drug application fees] and
supplemental and other animal drug application fees
under subsection (a)(1)(A)(ii) shall be [$1,250,000 in
fiscal year 2004, $2,000,000 in fiscal year 2005, and
$2,500,000 in fiscal years 2006, 2007, and 2008.]
$3,815,000 for fiscal year 2009, $4,320,000 for fiscal
year 2010, $4,862,000 for fiscal year 2011, $5,442,000
for fiscal year 2012, and $6,061,000 for fiscal year
2013.
(2) Total fee revenues for product fees.--The total
fee revenues to be collected in product fees under
subsection (a)(2) shall be [$1,250,000 in fiscal year
2004, $2,000,000 in fiscal year 2005, and $2,500,000 in
fiscal years 2006, 2007, and 2008.] $3,815,000 for
fiscal year 2009, $4,320,000 for fiscal year 2010,
$4,862,000 for fiscal year 2011, $5,442,000 for fiscal
year 2012, and $6,061,000 for fiscal year 2013.
(3) Total fee revenues for establishment fees.--The
total fee revenues to be collected in establishment
fees under subsection (a)(3) shall be [$1,250,000 in
fiscal year 2004, $2,000,000 in fiscal year 2005, and
$2,500,000 in fiscal years 2006, 2007, and 2008.]
$3,815,000 for fiscal year 2009, $4,320,000 for fiscal
year 2010, $4,862,000 for fiscal year 2011, $5,442,000
for fiscal year 2012, and $6,061,000 for fiscal year
2013.
(4) Total fee revenues for sponsor fees.--The total
fee revenues to be collected in sponsor fees under
subsection (a)(4) shall be [$1,250,000 in fiscal year
2004, $2,000,000 in fiscal year 2005, and $2,500,000 in
fiscal years 2006, 2007, and 2008.] $3,815,000 for
fiscal year 2009, $4,320,000 for fiscal year 2010,
$4,862,000 for fiscal year 2011, $5,442,000 for fiscal
year 2012, and $6,061,000 for fiscal year 2013.
(c) Adjustments.--
[(1) Inflation adjustment.--The revenues established
in subsection (b) shall be adjusted by the Secretary by
notice, published in the Federal Register, for a fiscal
year to reflect the greater of--
[(A) the total percentage change that
occurred in the Consumer Price Index for all
urban consumers (all items; United States city
average) for the 12-month period ending June 30
preceding the fiscal year for which fees are
being established; or
[(B) the total percentage change for the
previous fiscal year in basic pay under the
General Schedule in accordance with section
5332 of title 5, United States Code, as
adjusted by any locality-based comparability
payment pursuant to section 5304 of such title
for Federal employees stationed in the District
of Columbia.
The adjustment made each fiscal year by this subsection
will be added on a compounded basis to the sum of all
adjustments made each fiscal year after fiscal year
2004 under this subsection.]
[(2)] (1) Workload adjustment.--[After the fee
revenues are adjusted for inflation in accordance with
paragraph (1), the fee revenues shall be further
adjusted each fiscal year after fiscal year 2004] 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) * * *
(B) Under no circumstances shall this
workload adjustment result in fee revenues for
a fiscal year that are less than the fee
revenues for that fiscal year established in
subsection (b)[, as adjusted for inflation
under paragraph (1)].
[(3)] (2) Final year adjustment.--For fiscal year
[2008] 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 animal drug applications for the first 3
months of fiscal year [2009] 2014. If the Food and Drug
Administration has carryover balances for the process
for the review of animal drug applications in excess of
3 months of such operating reserves, then this
adjustment will not be made. If this adjustment is
necessary, then the rationale for the amount of the
increase shall be contained in the annual notice
setting fees for fiscal year [2008] 2013.
[(4)] (3) Annual fee setting.--The Secretary shall
establish, 60 days before the start of each fiscal year
beginning after September 30, 2003, for that fiscal
year, animal drug application fees, supplemental animal
drug application fees, animal drug sponsor fees, animal
drug establishment fees, and animal drug product fees
based on the revenue amounts established under
subsection (b) and the adjustments provided under this
subsection.
[(5)] (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 animal drug applications.
* * * * * * *
(g) Crediting and Availability of Fees.--
(1) * * *
* * * * * * *
(3) Authorization of appropriations.--There are
authorized to be appropriated for fees under this
section--
[(A) $5,000,000 for fiscal year 2004;
[(B) $8,000,000 for fiscal year 2005;
[(C) $10,000,000 for fiscal year 2006;
[(D) $10,000,000 for fiscal year 2007; and
[(E) $10,000,000 for fiscal year 2008;]
(A) $15,260,000 for fiscal year 2009;
(B) $17,280,000 for fiscal year 2010;
(C) $19,448,000 for fiscal year 2011;
(D) $21,768,000 for fiscal year 2012; and
(E) $24,244,000 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 animal drug application
fees, supplemental animal drug application fees, animal
drug sponsor fees, animal drug establishment fees, and
animal drug product fees.
[(4) Offset.--Any amount of fees collected for a
fiscal year under this section that exceeds the amount
of fees specified in appropriations Acts for such
fiscal year shall be credited to the appropriation
account of the Food and Drug Administration as provided
in paragraph (1), and shall be subtracted from the
amount of fees that would otherwise be authorized to be
collected under this section pursuant to appropriation
Acts for a subsequent fiscal year.]
(4) Offset.--If the sum of the cumulative amount of
fees collected under this section for 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.
* * * * * * *
SEC. 740A. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Report.--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 Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in
section 1(c) of the Animal Drug User Fee Amendments of 2008
toward expediting the animal drug development process and the
review of the new and supplemental animal drug applications and
investigational animal drug submissions during such fiscal
year, the future plans of the Food and Drug Administration for
meeting the goals, the review times for abbreviated new animal
drug applications, and the administrative procedures adopted by
the Food and Drug Administration to ensure that review times
for abbreviated new animal drug applications are not increased
from their current level due to activities under the user fee
program.
(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 the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected during such fiscal year for which the
report is made.
(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 the Congress with respect to the goals, and
plans for meeting the goals, for the process for the
review of animal drug applications 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 the
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 the 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.
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CHAPTER VIII--IMPORTS AND EXPORTS
IMPORTS AND EXPORTS
Sec. 801. (a) The Secretary of the Treasury shall deliver to
the Secretary of Health and Human Services, upon his request,
samples of food, drugs, devices, and cosmetics which are being
imported or offered for import into the United States, giving
notice thereof to the owner or consignee, who may appear before
the Secretary of Health and Human Services and have the right
to introduce testimony. The Secretary of Health and Human
Services shall furnish to the Secretary of the Treasury a list
of establishments registered pursuant to subsection (i) of
section 510 and shall request that if any drugs or devices
manufactured, prepared, propagated, compounded, or processed in
an establishment not so registered are imported or offered for
import into the United States, samples of such drugs or devices
be delivered to the Secretary of Health and Human Services,
with notice of such delivery to the owner or consignee, who may
appear before the Secretary of Health and Human Services and
have the right to introduce testimony. If it appears from the
examination of such samples or otherwise that (1) such article
has been manufactured, processed, or packed under insanitary
conditions or, in the case of a device, the methods used in, or
the facilities or controls used for, the manufacture, packing,
storage, or installation of the device do not conform to the
requirements of section 520(f), or (2) such article is
forbidden or restricted in sale in the country in which it was
produced or from which it was exported, or (3) such article is
adulterated, misbranded, or in violation of section 505, or
prohibited from introduction or delivery for introduction into
interstate commerce under section 301(ll), or (4) such article
is a counterfeit drug intended for use for animals other than
man, then such article shall be refused admission, except as
provided in subsection (b) of this section. If such article is
subject to a requirement under section 760 or 761 and if the
Secretary has credible evidence or information indicating that
the responsible person (as defined in such section 760 or 761)
has not complied with a requirement of such section 760 or 761
with respect to any such article, or has not allowed access to
records described in such section 760 or 761, then such article
shall be refused admission, except as provided in subsection
(b) of this section. The Secretary of the Treasury shall cause
the destruction of any such article refused admission unless
such article is exported, under regulations prescribed by the
Secretary of the Treasury, within ninety days of the date of
notice of such refusal or within such additional time as may be
permitted pursuant to such regulations. [Clause (2) of the
third sentence of this paragraph] Notwithstanding the preceding
sentence, the Secretary of the Treasury shall cause the
destruction of any such article refused admission if (1) the
article is a drug intended for use for animals other than man,
the article appears to be adulterated, misbranded, or in
violation of section 505, and the article has a value less than
$2,000 or such amount as the Secretary of Health and Human
Services may determine by regulation; or (2) the article
appears to be a counterfeit drug intended for use for animals
other than man. Clause (2) of the third sentence of this
subsection shall not be construed to prohibit the admission of
narcotic drugs the importation of which is permitted under the
Controlled Substances Import and Export Act.
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