[Pages H2984-H2993]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

ANIMAL DRUG AND ANIMAL GENERIC DRUG USER FEE REAUTHORIZATION ACT OF
2013

Mr. LATTA. Mr. Speaker, I move to suspend the rules and pass the bill
(S. 622) to amend the Federal Food, Drug, and Cosmetic Act to
reauthorize user fee programs relating to new animal drugs and generic
new animal drugs.
The Clerk read the title of the bill.
The text of the bill is as follows:

S. 622

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Animal Drug and Animal
Generic Drug User Fee Reauthorization Act of 2013''.

SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.

(a) Table of Contents.--The table of contents of this Act
is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents; references in Act.

TITLE I--FEES RELATING TO ANIMAL DRUGS

Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use animal drug fees.

[[Page H2985]]

Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Savings clause.
Sec. 106. Effective date.
Sec. 107. Sunset dates.

TITLE II--FEES RELATING TO GENERIC ANIMAL DRUGS

Sec. 201. Short title; finding.
Sec. 202. Authority to assess and use generic new animal drug fees.
Sec. 203. Reauthorization; reporting requirements.
Sec. 204. Savings clause.
Sec. 205. Effective date.
Sec. 206. Sunset dates.

(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.).

TITLE I--FEES RELATING TO ANIMAL DRUGS

SEC. 101. SHORT TITLE; FINDING.

(a) Short Title.--This title may be cited as the ``Animal
Drug User Fee Amendments of 2013''.
(b) Finding.--Congress finds that the fees authorized by
the amendments made in this title 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. 102. DEFINITIONS.

Section 739 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-11) is amended to read as follows:

``SEC. 739. DEFINITIONS.

``For purposes of this part:
``(1) The term `animal drug application' means an
application for approval of any new animal drug submitted
under section 512(b)(1). Such term does not include either a
new animal drug application submitted under section 512(b)(2)
or a supplemental animal drug application.
``(2) The term `supplemental animal drug application'
means--
``(A) a request to the Secretary to approve a change in an
animal drug application which has been approved; or
``(B) a request to the Secretary to approve a change to an
application approved under section 512(c)(2) for which data
with respect to safety or effectiveness are required.
``(3) The term `animal drug product' means each specific
strength or potency of a particular active ingredient or
ingredients in final dosage form marketed by a particular
manufacturer or distributor, which is uniquely identified by
the labeler code and product code portions of the national
drug code, and for which an animal drug application or a
supplemental animal drug application has been approved.
``(4) The term `animal drug establishment' means a foreign
or domestic place of business which is at one general
physical location consisting of one or more buildings all of
which are within 5 miles of each other, at which one or more
animal drug products are manufactured in final dosage form.
``(5) The term `investigational animal drug submission'
means--
``(A) the filing of a claim for an investigational
exemption under section 512(j) for a new animal drug intended
to be the subject of an animal drug application or a
supplemental animal drug application; or
``(B) the submission of information for the purpose of
enabling the Secretary to evaluate the safety or
effectiveness of an animal drug application or supplemental
animal drug application in the event of their filing.
``(6) The term `animal drug sponsor' means either an
applicant named in an animal drug application 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.
``(7) The term `final dosage form' means, with respect to
an animal drug product, a finished dosage form which is
approved for administration to an animal without substantial
further manufacturing. Such term includes animal drug
products intended for mixing in animal feeds.
``(8) The term `process for the review of animal drug
applications' means the following activities of the Secretary
with respect to the review of animal drug applications,
supplemental animal drug applications, and investigational
animal drug submissions:
``(A) The activities necessary for the review of animal
drug applications, supplemental animal drug applications, and
investigational animal drug submissions.
``(B) The issuance of action letters which approve animal
drug applications or supplemental animal drug applications or
which set forth in detail the specific deficiencies in animal
drug applications, supplemental animal drug applications, or
investigational animal drug submissions and, where
appropriate, the actions necessary to place such
applications, supplements or submissions in condition for
approval.
``(C) The inspection of animal drug establishments and
other facilities undertaken as part of the Secretary's review
of pending animal drug applications, supplemental animal drug
applications, and investigational animal drug submissions.
``(D) Monitoring of research conducted in connection with
the review of animal drug applications, supplemental animal
drug applications, and investigational animal drug
submissions.
``(E) The development of regulations and policy related to
the review of animal drug applications, supplemental animal
drug applications, and investigational animal drug
submissions.
``(F) Development of standards for products subject to
review.
``(G) Meetings between the agency and the animal drug
sponsor.
``(H) Review of advertising and labeling prior to approval
of an animal drug application or supplemental animal drug
application, but not after such application has been
approved.
``(9) The term `costs of resources allocated for the
process for the review of animal drug applications' means the
expenses in connection with the process for the review of
animal drug applications for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees consulted with respect to
the review of specific animal drug applications, supplemental
animal drug applications, or investigational animal drug
submissions, and costs related to such officers, employees,
committees, and contractors, including costs for travel,
education, and recruitment and other personnel activities;
``(B) management of information and the acquisition,
maintenance, and repair of computer resources;
``(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(D) collecting fees under section 740 and accounting for
resources allocated for the review of animal drug
applications, supplemental animal drug applications, and
investigational animal drug submissions.
``(10) The term `adjustment factor' applicable to a fiscal
year refers to the formula set forth in section 735(8) with
the base or comparator month being October 2002.
``(11) The term `person' includes an affiliate thereof.
``(12) The term `affiliate' refers to the definition set
forth in section 735(11).''.

SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.

Section 740 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-12) is amended to read as follows:

``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 (c) for an animal
drug application, except an animal drug application subject
to the criteria set forth in section 512(d)(4).
``(ii) A fee established in subsection (c), 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) Payment.--The fee required by subparagraph (A) shall
be due upon submission of the animal drug application or
supplemental animal drug application.
``(C) Exception for previously filed application or
supplement.--If an animal drug application or a supplemental
animal drug application was submitted by a person that paid
the fee for such application or supplement, was accepted for
filing, and was not approved or was withdrawn (without a
waiver or refund), the submission of an animal drug
application or a supplemental animal drug application for the
same product by the same person (or the person's licensee,
assignee, or successor) shall not be subject to a fee under
subparagraph (A).
``(D) Refund of fee if application refused for filing.--The
Secretary shall refund 75 percent of the fee paid under
subparagraph (B) for any animal drug application or
supplemental animal drug application which is refused for
filing.
``(E) Refund of fee if application withdrawn.--If an animal
drug application or a supplemental animal drug application is
withdrawn after the application or supplement was filed, the
Secretary may refund the fee or portion of the fee paid under
subparagraph (B) if no substantial work was performed on the
application or supplement after the application or supplement
was filed. The Secretary shall have the sole discretion to
refund the fee under this paragraph. A determination by the
Secretary concerning a refund under this paragraph shall not
be reviewable.

[[Page H2986]]

``(2) Animal drug product fee.--
``(A) In general.--Each person--
``(i) who is named as the applicant in an animal drug
application or supplemental animal drug application for an
animal drug product which has been submitted for listing
under section 510; and
``(ii) who, after September 1, 2003, had pending before the
Secretary an animal drug application or supplemental animal
drug application,
shall pay for each such animal drug product the annual fee
established in subsection (c).
``(B) Payment; fee due date.--Such fee shall be payable for
the fiscal year in which the animal drug product is first
submitted for listing under section 510, or is submitted for
relisting under section 510 if the animal drug product has
been withdrawn from listing and relisted. After such fee is
paid for that fiscal year, such fee shall be due each
subsequent fiscal year that the product remains listed, upon
the later of--
``(i) the first business day after the date of enactment of
an appropriations Act providing for the collection and
obligation of fees for such fiscal year under this section;
or
``(ii) January 31 of each year.
``(C) Limitation.--Such fee shall be paid only once for
each animal drug product for a fiscal year in which the fee
is payable.
``(3) Animal drug establishment fee.--
``(A) In general.--Each person--
``(i) who owns or operates, directly or through an
affiliate, an animal drug establishment;
``(ii) who is named as the applicant in an animal drug
application or supplemental animal drug application for an
animal drug product which has been submitted for listing
under section 510; and
``(iii) who, after September 1, 2003, had pending before
the Secretary an animal drug application or supplemental
animal drug application,
shall be assessed an annual establishment fee as established
in subsection (c) for each animal drug establishment listed
in its approved animal drug application as an establishment
that manufactures the animal drug product named in the
application.
``(B) Payment; fee due date.--The annual establishment fee
shall be assessed in each fiscal year in which the animal
drug product named in the application is assessed a fee under
paragraph (2) unless the animal drug establishment listed in
the application does not engage in the manufacture of the
animal drug product during the fiscal year. The fee under
this paragraph for a fiscal year shall be due upon the later
of--
``(i) the first business day after the date of enactment of
an appropriations Act providing for the collection and
obligation of fees for such fiscal year under this section;
or
``(ii) January 31 of each year.
``(C) Limitation.--
``(i) In general.--An establishment shall be assessed only
one fee per fiscal year under this section, subject to clause
(ii).
``(ii) Certain manufacturers.--If a single establishment
manufactures both animal drug products and prescription drug
products, as defined in section 735(3), such establishment
shall be assessed both the animal drug establishment fee and
the prescription drug establishment fee, as set forth in
section 736(a)(2), within a single fiscal year.
``(4) Animal drug sponsor fee.--
``(A) In general.--Each person--
``(i) who meets the definition of an animal drug sponsor
within a fiscal year; and
``(ii) who, after September 1, 2003, had pending before the
Secretary an animal drug application, a supplemental animal
drug application, or an investigational animal drug
submission,
shall be assessed an annual sponsor fee as established under
subsection (c).
``(B) Payment; fee due date.--The fee under this paragraph
for a fiscal year shall be due upon the later of--
``(i) the first business day after the date of enactment of
an appropriations Act providing for the collection and
obligation of fees for such fiscal year under this section;
or
``(ii) January 31 of each year.
``(C) Limitation.--Each animal drug sponsor shall pay only
one such fee each fiscal year.
``(b) Fee Revenue Amounts.--
``(1) In general.--Subject to subsections (c), (d), (f),
and (g)--
``(A) for fiscal year 2014, the fees required under
subsection (a) shall be established to generate a total
revenue amount of $23,600,000; and
``(B) for each of fiscal years 2015 through 2018, the fees
required under subsection (a) shall be established to
generate a total revenue amount of $21,600,000.
``(2) Types of fees.--Of the total revenue amount
determined for a fiscal year under paragraph (1)--
``(A) 20 percent shall be derived from fees under
subsection (a)(1) (relating to animal drug applications and
supplements);
``(B) 27 percent shall be derived from fees under
subsection (a)(2) (relating to animal drug products);
``(C) 26 percent shall be derived from fees under
subsection (a)(3) (relating to animal drug establishments);
and
``(D) 27 percent shall be derived from fees under
subsection (a)(4) (relating to animal drug sponsors).
``(c) Annual Fee Setting; Adjustments.--
``(1) 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.
``(2) Inflation adjustment.--For fiscal year 2015 and
subsequent fiscal years, the revenue amounts established in
subsection (b) shall be adjusted by the Secretary by notice,
published in the Federal Register, for a fiscal year, by an
amount equal to the sum of--
``(A) one;
``(B) the average annual percent change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and benefits
paid with respect to such positions for the first 3 of the
preceding 4 fiscal years for which data are available,
multiplied by the average proportion of personnel
compensation and benefits costs to total Food and Drug
Administration costs for the first 3 years of the preceding 4
fiscal years for which data are available; and
``(C) the average annual percent change that occurred in
the Consumer Price Index for urban consumers (Washington-
Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items
less food and energy; annual index) for the first 3 years of
the preceding 4 years for which data are available multiplied
by the average proportion of all costs other than personnel
compensation and benefits costs to total Food and Drug
Administration costs for the first 3 years of the preceding 4
fiscal years for which data are available.
The adjustment made each fiscal year under this paragraph
shall be added on a compounded basis to the sum of all
adjustments made each fiscal year after fiscal year 2014
under this paragraph.
``(3) Workload adjustment.--For fiscal year 2015 and
subsequent fiscal years, after the revenue amounts
established in subsection (b) are adjusted for inflation in
accordance with paragraph (2), the revenue amounts shall be
further adjusted for such fiscal year to reflect changes in
the workload of the Secretary for the process for the review
of animal drug applications. With respect to such
adjustment--
``(A) such adjustment shall be determined by the Secretary
based on a weighted average of the change in the total number
of animal drug applications, supplemental animal drug
applications for which data with respect to safety or
effectiveness are required, manufacturing supplemental animal
drug applications, investigational animal drug study
submissions, and investigational animal drug protocol
submissions submitted to the Secretary;
``(B) the Secretary shall publish in the Federal Register
the fees resulting from such adjustment and the supporting
methodologies; and
``(C) under no circumstances shall such 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 (2).
``(4) Final year adjustment.--For fiscal year 2018, the
Secretary may, in addition to other adjustments under this
subsection, further increase the fees under this section, if
such an adjustment is necessary, 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 2019. 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 2018.
``(5) Limit.--The total amount of fees charged, as adjusted
under this subsection, for a fiscal year may not exceed the
total costs for such fiscal year for the resources allocated
for the process for the review of animal drug applications.
``(d) Fee Waiver or Reduction.--
``(1) In general.--The Secretary shall grant a waiver from
or a reduction of one or more fees assessed under subsection
(a) where the Secretary finds that--
``(A) the assessment of the fee would present a significant
barrier to innovation because of limited resources available
to such person or other circumstances;
``(B) the fees to be paid by such person will exceed the
anticipated present and future costs incurred by the
Secretary in conducting the process for the review of animal
drug applications for such person;
``(C) the animal drug application or supplemental animal
drug application is intended solely to provide for use of the
animal drug in--
``(i) a Type B medicated feed (as defined in section
558.3(b)(3) of title 21, Code of Federal Regulations (or any
successor regulation)) intended for use in the manufacture of
Type C free-choice medicated feeds; or
``(ii) a Type C free-choice medicated feed (as defined in
section 558.3(b)(4) of title 21, Code of Federal Regulations
(or any successor regulation));
``(D) the animal drug application or supplemental animal
drug application is intended solely to provide for a minor
use or minor species indication; or

[[Page H2987]]

``(E) the sponsor involved is a small business submitting
its first animal drug application to the Secretary for
review.
``(2) Use of standard costs.--In making the finding in
paragraph (1)(B), the Secretary may use standard costs.
``(3) Rules for small businesses.--
``(A) Definition.--In paragraph (1)(E), the term `small
business' means an entity that has fewer than 500 employees,
including employees of affiliates.
``(B) Waiver of application fee.--The Secretary shall waive
under paragraph (1)(E) the application fee for the first
animal drug application that a small business or its
affiliate submits to the Secretary for review. After a small
business or its affiliate is granted such a waiver, the small
business or its affiliate shall pay application fees for all
subsequent animal drug applications and supplemental animal
drug applications for which safety or effectiveness data are
required in the same manner as an entity that does not
qualify as a small business.
``(C) Certification.--The Secretary shall require any
person who applies for a waiver under paragraph (1)(E) to
certify their qualification for the waiver. The Secretary
shall periodically publish in the Federal Register a list of
persons making such certifications.
``(e) Effect of Failure To Pay Fees.--An animal drug
application or supplemental animal drug application submitted
by a person subject to fees under subsection (a) shall be
considered incomplete and shall not be accepted for filing by
the Secretary until all fees owed by such person have been
paid. An investigational animal drug submission under section
739(5)(B) that is submitted by a person subject to fees under
subsection (a) shall be considered incomplete and shall not
be accepted for review by the Secretary until all fees owed
by such person have been paid. The Secretary may discontinue
review of any animal drug application, supplemental animal
drug application or investigational animal drug submission
from a person if such person has not submitted for payment
all fees owed under this section by 30 days after the date
upon which they are due.
``(f) Assessment of Fees.--
``(1) Limitation.--Fees may not be assessed under
subsection (a) for a fiscal year beginning after fiscal year
2003 unless appropriations for salaries and expenses of the
Food and Drug Administration for such fiscal year (excluding
the amount of fees appropriated for such fiscal year) are
equal to or greater than the amount of appropriations for the
salaries and expenses of the Food and Drug Administration for
the fiscal year 2003 (excluding the amount of fees
appropriated for such fiscal year) multiplied by the
adjustment factor applicable to the fiscal year involved.
``(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal year
because of paragraph (1) and if at a later date in such
fiscal year the Secretary may assess such fees, the Secretary
may assess and collect such fees, without any modification in
the rate, for animal drug applications, supplemental animal
drug applications, investigational animal drug submissions,
animal drug sponsors, animal drug establishments and animal
drug products at any time in such fiscal year notwithstanding
the provisions of subsection (a) relating to the date fees
are to be paid.
``(g) Crediting and Availability of Fees.--
``(1) In general.--Subject to paragraph (2)(C), fees
authorized under subsection (a) shall be collected and
available for obligation only to the extent and in the amount
provided in advance in appropriations Acts. Such fees are
authorized to be appropriated to remain available until
expended. Such sums as may be necessary may be transferred
from the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salary and expenses with such
fiscal year limitation. The sums transferred shall be
available solely for the process for the review of animal
drug applications.
``(2) Collections and appropriation acts.--
``(A) In general.--The fees authorized by this section--
``(i) subject to subparagraph (C), shall be collected and
available 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 be available to defray increases in the costs
of the resources allocated for the process for the review of
animal drug applications (including increases in such costs
for an additional number of full-time equivalent positions in
the Department of Health and Human Services to be engaged in
such process) over such costs, excluding costs paid from fees
collected under this section, for fiscal year 2003 multiplied
by the adjustment factor.
``(B) Compliance.--The Secretary shall be considered to
have met the requirements of subparagraph (A)(ii) in any
fiscal year if the costs funded by appropriations and
allocated for the process for the review of animal drug
applications--
``(i) are not more than 3 percent below the level specified
in subparagraph (A)(ii); or
``(ii)(I) are more than 3 percent below the level specified
in subparagraph (A)(ii), and fees assessed for the fiscal
year following the subsequent fiscal year are decreased by
the amount in excess of 3 percent by which such costs fell
below the level specified in subparagraph (A)(ii); and
``(II) such costs are not more than 5 percent below the
level specified in subparagraph (A)(ii).
``(C) Provision for early payments.--Payment of fees
authorized under this section for a fiscal year, prior to the
due date for such fees, may be accepted by the Secretary in
accordance with authority provided in advance in a prior year
appropriations Act.
``(3) Authorization of appropriations.--For each of the
fiscal years 2014 through 2018, there is authorized to be
appropriated for fees under this section an amount equal to
the total revenue amount determined under subsection (b) for
the fiscal year, as adjusted or otherwise affected under
subsection (c) and paragraph (4).
``(4) Offset of overcollections; recovery of collection
shortfalls.--
``(A) Offset of overcollections.--If the sum of the
cumulative amount of fees collected under this section for
fiscal years 2014 through 2016 and the amount of fees
estimated to be collected under this section for fiscal year
2017 (including any increased fee collections attributable to
subparagraph (B)), exceeds the cumulative amount appropriated
pursuant to paragraph (3) for the fiscal years 2014 through
2017, 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 2018.
``(B) Recovery of collection shortfalls.--
``(i) Fiscal year 2016.--For fiscal year 2016, the amount
of fees otherwise authorized to be collected under this
section shall be increased by the amount, if any, by which
the amount collected under this section and appropriated for
fiscal year 2014 falls below the amount of fees authorized
for fiscal year 2014 under paragraph (3).
``(ii) Fiscal year 2017.--For fiscal year 2017, the amount
of fees otherwise authorized to be collected under this
section shall be increased by the amount, if any, by which
the amount collected under this section and appropriated for
fiscal year 2015 falls below the amount of fees authorized
for fiscal year 2015 under paragraph (3).
``(iii) Fiscal year 2018.--For fiscal year 2018, the amount
of fees otherwise authorized to be collected under this
section (including any reduction in the authorized amount
under subparagraph (A)), shall be increased by the cumulative
amount, if any, by which the amount collected under this
section and appropriated for fiscal years 2016 and 2017
(including estimated collections for fiscal year 2017) falls
below the cumulative amount of fees authorized under
paragraph (3) for fiscal years 2016 and 2017.
``(h) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States
Code.
``(i) Written Requests for Waivers, Reductions, and
Refunds.--To qualify for consideration for a waiver or
reduction under subsection (d), or for a refund of any fee
collected in accordance with subsection (a), a person shall
submit to the Secretary a written request for such waiver,
reduction, or refund not later than 180 days after such fee
is due.
``(j) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in the process
of the review of animal drug applications, be reduced to
offset the number of officers, employees, and advisory
committees so engaged.
``(k) Abbreviated New Animal Drug Applications.--The
Secretary shall--
``(1) to the extent practicable, segregate the review of
abbreviated new animal drug applications from the process for
the review of animal drug applications; and
``(2) adopt other administrative procedures to ensure that
review times of abbreviated new animal drug applications do
not increase from their current level due to activities under
the user fee program.''.

SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.

Section 740A of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-13) is amended to read as follows:

``SEC. 740A. REAUTHORIZATION; REPORTING REQUIREMENTS.

``(a) Performance Report.--Beginning with fiscal year 2014,
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
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 101(b) of the Animal Drug
User Fee Amendments of 2013 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

[[Page H2988]]

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 2014, 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 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 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 2018, and for the reauthorization of this part
for such fiscal years, the Secretary shall consult with--
``(A) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(B) the Committee on Energy and Commerce of the House of
Representatives;
``(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, 2018, 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. 105. SAVINGS CLAUSE.

Notwithstanding the amendments made by this title, 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 title, 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 October
1, 2008, but before October 1, 2013, 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 2014.

SEC. 106. EFFECTIVE DATE.

The amendments made by this title shall take effect on
October 1, 2013, or the date of enactment of this Act,
whichever is later, except that fees under part 4 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act, as amended by this title, shall be assessed for
all animal drug applications and supplemental animal drug
applications received on or after October 1, 2013, regardless
of the date of the enactment of this Act.

SEC. 107. SUNSET DATES.

(a) Authorization.--Section 740 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-12) shall cease to be
effective October 1, 2018.
(b) Reporting Requirements.--Section 740A of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-13) shall cease
to be effective January 31, 2019.
(c) Previous Sunset Provision.--
(1) In general.--Section 108 of the Animal Drug User Fee
Amendments of 2008 (Public Law 110-316) is repealed.
(2) Conforming amendment.--The Animal Drug User Fee
Amendments of 2008 (Public Law 110-316) is amended in the
table of contents in section 1, by striking the item relating
to section 108.
(d) Technical Clarification.--Effective November 18, 2003,
section 5 of the Animal Drug User Fee Act of 2003 (Public Law
108-130) is repealed.

TITLE II--FEES RELATING TO GENERIC ANIMAL DRUGS

SEC. 201. SHORT TITLE; FINDING.

(a) Short Title.--This title may be cited as the ``Animal
Generic Drug User Fee Amendments of 2013''.
(b) Finding.--The fees authorized by this title 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. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG
FEES.

Section 741 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-21) is amended to read as follows:

``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 (c) for such an application.
``(B) Payment.--The fee required by subparagraph (A) shall
be due upon submission of the abbreviated application.
``(C) Exceptions.--
``(i) 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).
``(ii) Certain abbreviated applications involving
combination animal drugs.--An abbreviated application which
is subject to the criteria in section 512(d)(4) and submitted
on or after October 1, 2013 shall be subject to a fee equal
to 50 percent of the amount of the abbreviated application
fee established in subsection (c).
``(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.--
``(A) In general.--Each person--
``(i) 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
``(ii) 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 (c).
``(B) Payment; fee due date.--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,

[[Page H2989]]

such fee shall be due each subsequent fiscal year that the
product remains listed, upon the later of--
``(i) the first business day after the date of enactment of
an appropriations Act providing for the collection and
obligation of fees for such fiscal year under this section;
or
``(ii) January 31 of each year.
``(C) Limitation.--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 generic new animal drug sponsor
fee as established under subsection (c).
``(B) Payment; fee due date.--Such fee shall be due each
fiscal year upon the later of--
``(i) the first business day after the date of enactment of
an appropriations Act providing for the collection and
obligation of fees for such fiscal year under this section;
or
``(ii) January 31 of each year.
``(C) 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) 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) 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) for an applicant with 1 or fewer approved
abbreviated applications.
``(b) Fee Amounts.--Subject to 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 $1,832,000 for fiscal year
2014, $1,736,000 for fiscal year 2015, $1,857,000 for fiscal
year 2016, $1,984,000 for fiscal year 2017, and $2,117,000
for fiscal year 2018.
``(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 $2,748,000 for fiscal
year 2014, $2,604,000 for fiscal year 2015, $2,786,000 for
fiscal year 2016, $2,976,000 for fiscal year 2017, and
$3,175,000 for fiscal year 2018.
``(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 $2,748,000 for fiscal
year 2014, $2,604,000 for fiscal year 2015, $2,786,000 for
fiscal year 2016, $2,976,000 for fiscal year 2017, and
$3,175,000 for fiscal year 2018.
``(c) Annual Fee Setting; Adjustments.--
``(1) 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.
``(2) Workload adjustment.--The fee revenues shall be
adjusted each fiscal year after fiscal year 2014 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).
``(3) Final year adjustment.--For fiscal year 2018, the
Secretary may, in addition to other adjustments under this
subsection, further increase the fees under this section, if
such an adjustment is necessary, 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 2019. 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 2018.
``(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.--Subject to paragraph (2)(C), 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) subject to subparagraph (C), shall be collected and
available 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 be 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).
``(C) Provision for early payments.--Payment of fees
authorized under this section for a fiscal year, prior to the
due date for such fees, may be accepted by the Secretary in
accordance with authority provided in advance in a prior year
appropriations Act.
``(3) Authorization of appropriations.--There are
authorized to be appropriated for fees under this section--
``(A) $7,328,000 for fiscal year 2014;
``(B) $6,944,000 for fiscal year 2015;
``(C) $7,429,000 for fiscal year 2016;

[[Page H2990]]

``(D) $7,936,000 for fiscal year 2017; and
``(E) $8,467,000 for fiscal year 2018;
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 2014
through 2016 and the amount of fees estimated to be collected
under this section for fiscal year 2017 exceeds the
cumulative amount appropriated under paragraph (3) for the
fiscal years 2014 through 2017, 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 2018.
``(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 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. 203. REAUTHORIZATION; REPORTING REQUIREMENTS.

Section 742 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-22) is amended to read as follows:

``SEC. 742. REAUTHORIZATION; REPORTING REQUIREMENTS.

``(a) Performance Reports.--Beginning with fiscal year
2014, 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
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 201(b) of the Animal Generic
Drug User Fee Amendments of 2013 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 2014, 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 2018, and for the
reauthorization of

[[Page H2991]]

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, 2018, 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. 204. SAVINGS CLAUSE.

Notwithstanding the amendments made by this title, part 5
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act, as in effect on the day before the date of
enactment of this title, shall continue to be in effect with
respect to abbreviated applications for a generic new animal
drug and supplemental abbreviated applications for a generic
new animal drug (as defined in such part as of such day) that
on or after October 1, 2008, but before October 1, 2013, 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 2014.

SEC. 205. EFFECTIVE DATE.

The amendments made by this title shall take effect on
October 1, 2013, or the date of enactment of this Act,
whichever is later, except that fees under part 5 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act, as amended by this title, shall be assessed for
all abbreviated applications for a generic new animal drug
and supplemental abbreviated applications for a generic new
animal drug received on or after October 1, 2013, regardless
of the date of enactment of this Act.

SEC. 206. SUNSET DATES.

(a) Authorization.--Section 741 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-21) shall cease to be
effective October 1, 2018.
(b) Reporting Requirements.--Section 742 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-22) shall cease
to be effective January 31, 2019.
(c) Previous Sunset Provision.--
(1) In general.--Section 204 of the Animal Generic Drug
User Fee Act of 2008 (Public Law 110-316) is repealed.
(2) Conforming amendment.--The Animal Generic Drug User Fee
Act of 2008 (Public Law 110-316) is amended in the table of
contents in section 1, by striking the item relating to
section 204.

The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Ohio (Mr. Latta) and the gentleman from California (Mr. Waxman) each
will control 20 minutes.
The Chair recognizes the gentleman from Ohio.

General Leave

Mr. LATTA. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days in which to revise and extend their remarks and
insert extraneous material in the Record on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Ohio?
There was no objection.
Mr. LATTA. Mr. Speaker, I yield myself such time as I may consume.
I rise today in support of S. 622, the Animal Drug and Animal Generic
Drug User Fee Reauthorization Act of 2013. The Energy and Commerce
Committee passed H.R. 1407, a nearly identical bill, through the
committee last month with broad bipartisan support.
The agriculture industry, animal drug manufacturers, veterinarians,
pet owners, and the Food and Drug Administration have all found both
the Animal Drug User Fee and Animal Generic Drug User Fee to be very
effective, and have asked Congress to reauthorize the programs as soon
as possible. In addition, there is strong bipartisan support for the
programs, which I think is a reflection of their success and
effectiveness.
Passing S. 622 is extremely important for our Nation. First, having
quality and safe medications is essential for ensuring the safety of
our Nation's food supply chain. Second, these programs help livestock
producers, poultry producers, and veterinarians keep their animals
healthy. Third, these programs enable families to have safe and
affordable drugs for their pets so they can live longer and healthier
lives. It is essential that the House passes this bill swiftly so we
can guarantee that these programs continue without interruption.
I would like to thank my colleagues, Mr. Shimkus and Mr. Gardner, for
their hard work on this very important piece of legislation. It is no
small feat to move legislation to the President's desk in such an
efficient manner.
I would also like to thank our colleagues in the Senate, including
Senator Harkin and Senator Alexander, for their leadership.
Mr. Speaker, I support this bill, encourage my colleagues to do the
same, and I reserve the balance of my time.
Mr. WAXMAN. Mr. Speaker, I yield myself such time as I may consume.
I rise in support of H.R. 1407, the Animal Drug User Fee Amendments
of 2013. FDA's Animal Drug User Fee programs have been successful at
speeding both brand and generic drugs for animals to the market, and
that's important.
However, I regret that we have not taken this opportunity to provide
FDA with new tools to address a glaring public health crisis--the
problem of antibiotic resistance.
Antibiotics are truly a lifesaving gift. Unfortunately, the more they
are used, the less they work. Untold numbers of Americans die or are
infected each year by antibiotic-resistant bugs.
We know that most antibiotic use occurs on the farm, and much of this
issue is not to treat sick animals, but most of the use is for disease
prevention or growth promotion. If it's for treating sick animals, no
one could quarrel with that. Unfortunately, if it's used for growth
promotion or disease prevention, that is a misuse of it and could lead
to antibiotic-resistant bugs.
We don't know exactly how much is for which of these two uses of the
drug. That's why we need to ask industry to give us more data on how
these drugs are being used, and to take steps to curtail the
inappropriate use in animals of important human antibiotics.
My bill, the Delivering Antibiotic Transparency in Animals, or DATA,
Act, would enhance the information FDA gets about how these drugs are
used. Representative Slaughter has a bill, which I have cosponsored,
the Preservation of Antibiotics for Medical Treatment Act, or PAMTA,
that would curtail the inappropriate use in animals of important human
antibiotics.
We need to ensure that FDA not only has the resources and procedures
for speeding safe and effective animal drugs to market, but also the
information and tools to ensure that they are being used judiciously.

[[Page H2992]]

{time} 1640

I regret that we are not taking this opportunity to give FDA these
tools, but I hope we will soon have an opportunity to move these bills
forward.
Mr. Speaker, I ask unanimous consent that the control of the time on
my side of the aisle be given to the gentleman from North Carolina (Mr.
Butterfield), and I reserve the balance of my time.
The SPEAKER pro tempore. Without objection, the gentleman from North
Carolina will control the time.
There was no objection.
Mr. LATTA. Mr. Speaker, at this time, I yield 2 minutes to the
chairman of the full committee, the gentleman from Michigan (Mr.
Upton).
Mr. UPTON. I rise today in strong support of S. 622, the Animal Drug
and Animal Generic Drug User Fee Reauthorization Act of 2013.
This bipartisan bill is nearly identical to H.R. 1407, which we
favorably reported out of the Energy and Commerce Committee last month.
This bill, as well as the Animal Generic Drug User Fee Act, has proven
to be very successful; and they are so important for the Nation's
public health. Congress first created ADUFA back in 2003 and AGDUFA in
2008. Collectively, these programs have yielded many benefits for the
American public.
These two bills have ensured that veterinarians, livestock, poultry
producers, and pet owners have access to new and affordable animal
drugs to keep their animals healthy. They have assisted animal drug
producers by fostering a stable and predictable FDA review process, a
rigorous process that helps expedite access to new therapies and
fosters new drug development. The programs have also helped American
consumers by keeping the food supply safe. Having medications that keep
our animals healthy is essential to keeping our Nation's food supply
safe. For companies like Zoetis, which employs some 700 people in
southwest Michigan, these programs are vital in allowing them to keep
producing innovative drugs for pets and livestock.
I was the lead sponsor of the original ADUFA legislation back in
2003, and it is terrific to see how successful it has been and how many
Americans it has helped over the last decade.
I want to thank my colleagues, particularly Mr. Shimkus and Mr.
Gardner, for their real leadership on this important issue. They
deserve tremendous credit as we work to get this bill to the
President's desk, and I urge my colleagues to support it.
Mr. BUTTERFIELD. Mr. Speaker, at this time, I yield such time as she
may consume to the gentlelady from New York (Ms. Slaughter).
Ms. SLAUGHTER. I thank my friend for yielding.
Mr. Speaker, just today, The New York Times reported that we are
simultaneously facing a shortage of effective antibiotics and the
growing threat of antibiotic-resistant bacteria. Already antibiotic-
resistant disease claims 70,000 American lives each year.
According to today's story, Dr. Janet Woodcock, the director of the
Center for Drug Evaluation and Research at the Food and Drug
Administration, has warned ``it is bad now, and the infectious disease
docs are frantic, but what is worse is the thought of where we will be
5 to 10 years from now.''
They are even desperate enough to ask GlaxoKleinSmith, which is
working on some new antibiotics, to allow the use of them untested--the
FDA is considering this--and to try, in perhaps what will turn out to
be a vain attempt, to save people who are dying from infections that we
can no longer cure. GlaxoKleinSmith has said the new antibiotics they
are working on they will not license for livestock feed.
Eighty percent of the antibiotics produced in the United States of
America is put every day in livestock feed. The major reason for the
increase in the antibiotic-resistant bacteria is the routine overuse of
antibiotics in the Nation's livestock. These are not sick livestock,
Mr. Speaker. This is simply put in the feed because they grow faster
and they are fatter and they can get to market a little quicker. This
irresponsible practice has already been scientifically linked to the
growth of superbugs.
It's clear--and it has been clear for quite a while--that the Federal
Government must act to end this dangerous practice. Yet,
incomprehensibly, for more than 35 years the United States Food and
Drug Administration has refused to follow its own advice and ban the
routine use of antibiotics in agriculture, not just use it for sick
animals. Instead, they have proposed voluntary guidance that naively
asks industry to put public welfare before private profits--something
the industry has repeatedly shown in 35 years they will not do.
As if such dereliction of duty were not enough, the FDA is now
panicked about the superbug threat that they helped to create; but
instead of finally removing routine antibiotic use from livestock
production, the FDA is thinking of waiving important drug-testing
procedures, as I said, in order to rush new drugs to market. The
testing procedures that are currently in place are in place for a
reason. Waiving these requirements sets a dangerous precedent and is
one that is only being considered because the FDA is panicked and has
refused to challenge the special interests that have helped to create
this superbug threat in the first place.
As the only legislator in Congress with a background in microbiology,
I can assure you we will never win the arms race against nature. As
long as we allow the irresponsible use of antibiotics in our society,
nature will always evolve to create stronger bacteria. As I said, with
80 percent of all of the antibiotics going to agricultural use, our
answer has to start on the farm. We have to end the unnecessary use of
antibiotics on healthy animals before it's too late. Indeed, it may
almost be too late.
At the very least today, the ADUFA legislation should include
language to collect important data on antibiotics. That provision would
at least allow us to finally learn the full scope of the problem that
we confront. Even more importantly, I urge my colleagues to support my
legislation, H.R. 1150, the Preservation of Antibiotics for Medical
Treatment Act, which would ban the routine use of eight important
classes of antibiotics in livestock, but still allow a sick animal to
be treated, and would help curb the growing threat of superbugs.
We are literally standing today on the brink of a public health
crisis as the food industrial complex fritters away one of the most
important advances in medical history--the beginning of the use of
antibiotics to cure human beings. Already, some strains of tuberculosis
have evolved that are incurable, and others are coming. Some experts
have said that if we don't do something soon--and it may already be too
late--that strep throat could become a fatal illness. That's what
they're worried about, what could happen here in 5 years.
I urge my colleagues to oppose this legislation today and to please
join me in the fight to protect the antibiotics for human health. It is
so important. I cannot vote for this bill, although I recognize that
some work has gone into it. I have spent years on this, and the years
are running out, and the time is short.
Mr. LATTA. Mr. Speaker, at this time, I yield 2 minutes to the
chairman of the subcommittee, the gentleman from Pennsylvania (Mr.
Pitts).
Mr. PITTS. I rise today in support of the reauthorization of two
successful programs--the Animal Drug User Fee Act, ADUFA, and the
Animal Generic Drug User Fee Act, AGDUFA.
The bill we have before us today originated in the Senate and was
approved by unanimous consent on May 8, 2013; and I urge my colleagues
in the House to support this legislation as well.
In 2003, the first ADUFA was authorized to help the Food and Drug
Administration's review of animal drugs. Similar to the Prescription
Drug User Fee for human drugs, under ADUFA, FDA collected funds to help
expedite the new animal drug approval process, to reduce application
backlog, and to improve communications with drug sponsors. The program
was authorized for 5 years, and Congress renewed the program for an
additional 5 years in ADUFA II in 2008. In 2012, FDA completed 747
ADUFA reviews; and, according to FDA, the agency has exceeded all
performance goals outlined in ADUFA I and ADUFA II. However, absent
congressional action, FDA's ability to collect these user fees will
expire on September 30, 2013.

[[Page H2993]]

{time} 1650

AGDUFA I, ADUFA's generic cousin, was first authorized in 2008 for 5
years in order to improve the review of abbreviated new animal drug
applications, eliminate application backlogs, and reduce review times.
To date, according to FDA, the agency has exceeded all performance
goals but one from AGDUFA I. This program also expires September 30,
2013, unless it is reauthorized and FDA and industry have negotiated an
agreement for AGDUFA II. These programs are extremely important not
only for our animals and livestock on our farms and ranches, but for
our pets' health and well-being as well.
I want to thank my colleagues, Representative John Shimkus and
Representative Cory Gardner, for their outstanding work on this
legislation, and I urge my colleagues to support this important
legislation.
Mr. BUTTERFIELD. I inquire as to whether the gentleman from Ohio has
any additional speakers.
Mr. LATTA. We have one, Mr. Speaker.
Mr. BUTTERFIELD. Then I will reserve the balance of my time.
Mr. LATTA. Mr. Speaker, at this time I yield 2 minutes to the
gentleman from Colorado (Mr. Gardner).
Mr. GARDNER. Mr. Speaker, I thank the gentleman for yielding time.
I rise today in support of Senate Bill 622, the Animal Drug and
Animal Generic Drug User Fee Reauthorization Act of 2013.
This legislation will reauthorize two very important programs at the
Food and Drug Administration that will provide farmers, ranchers, pet
owners, and veterinarians with speedy access to medications that they
need for the treatment of herds and pets.
I would like to thank Senator Harkin for leading its passage in the
U.S. Senate, and I would also like to thank Congressman Shimkus for his
leadership with the House version of H.R. 1407.
These programs have been a success story at the FDA, and this
legislation will ensure that drug approvals are done efficiently and to
the highest quality standards. ADUFA and AGDUFA expire at the start of
September, and we will need to pass this reauthorization today to
assure there is no delay for animal caretakers and livestock producers.
This bill will also help companies that develop and manufacture animal
drugs by providing predictable time lines. It will also help them to
benefit from a more stable review process so they can make decisions
about where to invest research dollars.
Colorado has a thriving livestock industry which supports rural
communities and economic strength for the entire State. I said this
during the committee markup of H.R. 1407: there is more livestock in my
district than people, or at least that's what I'm told. Colorado is
also home to one of the Nation's premier schools of veterinary medicine
at Colorado State University. Keeping livestock animals healthy, in
particular, is crucial to ensuring our own health, not to mention the
health of our family pets. The ADUFA and AGDUFA program keeps our food
healthy and safe, while the application of animal drugs poses no risk
to animal health.
I had the honor of introducing, with bipartisan support, H.R. 1408,
the Animal Generic Drug User Fee Act, or AGDUFA. The bill was later
incorporated into H.R. 1407. This program at FDA has achieved
noteworthy success since first being authorized in 2008. The FDA has
decreased a backlog of applications and reduced the review time for new
generic drug applications. The reauthorization of this program will
continue this success and allow our animal caretakers and livestock
producers to utilize cost savings associated with generic medications.
Mr. BUTTERFIELD. Mr. Speaker, I ask if my friend has any further
speakers on his side.
Mr. LATTA. I have none.
Mr. BUTTERFIELD. As we have no further speakers either, Mr. Speaker,
I yield back the balance of my time.
Mr. LATTA. Mr. Speaker, I ask for passage of S. 622, and I yield back
the balance of my time.
Mr. PALLONE. Mr. Speaker, I rise in strong support of S. 622, the
Animal Drug and Animal Generic Drug User Fee Reauthorization Act.
Congress enacted the Animal Drug User Fee Act (ADUFA) in 2003 to help
improve the FDA review of new animal drugs, and subsequently enacted
the Animal Generic Drug User Fee Act (AGDUFA) to improve the review of
abbreviated new animal drug applications, or generic versions of animal
drugs. These programs have been extremely effective, and have helped
expedite the approval process, reduce application backlogs, and improve
communications with drug sponsors.
Without congressional action, the current agreements will expire at
the end of this fiscal year, which would have a serious and harmful
impact on the ability of the FDA's Center for Veterinary Medicine to
review new and generic drug applications in a timely manner. S. 622
will extend FDA's authority to collect user fees from manufacturers for
five years.
I urge my colleagues to vote in favor of S. 622, so that progress is
not impeded and the Food and Drug Administration can continue to review
new and generic animal drug applications in a timely manner. Industry,
farmers, ranchers, and pet owners are counting on an uninterrupted
supply of animal drugs.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Ohio (Mr. Latta) that the House suspend the rules and
pass the bill, S. 622.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds
being in the affirmative, the ayes have it.
Mr. BUTTERFIELD. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further
proceedings on this motion will be postponed.

____________________