[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 622 Enrolled Bill (ENR)]
S.622
One Hundred Thirteenth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Thursday,
the third day of January, two thousand and thirteen
An Act
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user
fee programs relating to new animal drugs and generic new animal drugs.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
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.
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.
``(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
``(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
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, 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;
``(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 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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.