[Congressional Record Volume 159, Number 64 (Wednesday, May 8, 2013)]
[Senate]
[Pages S3275-S3282]
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. BLUMENTHAL. Mr. President, I ask unanimous consent that the
Senate proceed to the immediate consideration of Calendar No. 31, S.
622.
The PRESIDING OFFICER. The clerk will report the bill by title.
The assistant bill clerk read as follows:
A 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.
There being no objection, the Senate proceeded to consider the bill.
Mr. BLUMENTHAL. Mr. President, I further ask unanimous consent that
the bill be read a third time and passed and the motion to reconsider
be made and laid upon the table, with no intervening action or debate.
The PRESIDING OFFICER. Without objection, it is so ordered.
The bill (S. 622) was ordered to be engrossed for a third reading,
was read the third time, and passed, 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.
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.
[[Page S3276]]
``(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.
[[Page S3277]]
``(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
[[Page S3278]]
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
[[Page S3279]]
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
[[Page S3280]]
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.
[[Page S3281]]
``(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.
[[Page S3282]]
(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.
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