[Congressional Record (Bound Edition), Volume 159 (2013), Part 5]
[Senate]
[Pages 6539-6546]
[From the U.S. 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.

[[Page 6540]]

       ``(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

[[Page 6541]]

       ``(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

[[Page 6542]]

     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--

[[Page 6543]]

       ``(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.

[[Page 6544]]

       ``(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.

[[Page 6545]]

       ``(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.

[[Page 6546]]

       ``(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.

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