[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 622 Placed on Calendar Senate (PCS)]

                                                        Calendar No. 31
113th CONGRESS
  1st Session
                                 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.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 20, 2013

    Mr. Harkin, from the Committee on Health, Education, Labor, and 
 Pensions, reported the following original bill; which was read twice 
                       and placed on the calendar

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user 
fee programs relating to new animal drugs and generic new animal drugs.

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

SECTION 1. SHORT TITLE.

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

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

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

Sec. 1. Short title.
Sec. 2. Table of contents; references in Act.
                 TITLE I--FEES RELATING TO ANIMAL DRUGS

Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use animal drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Savings clause.
Sec. 106. Effective date.
Sec. 107. Sunset dates.
            TITLE II--FEES RELATING TO GENERIC ANIMAL DRUGS

Sec. 201. Short title; finding.
Sec. 202. Authority to assess and use generic new animal drug fees.
Sec. 203. Reauthorization; reporting requirements.
Sec. 204. Savings clause.
Sec. 205. Effective date.
Sec. 206. Sunset dates.
    (b) References in Act.--Except as otherwise specified, amendments 
made by this Act to a section or other provision of law are amendments 
to such section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).

                 TITLE I--FEES RELATING TO ANIMAL DRUGS

SEC. 101. SHORT TITLE; FINDING.

    (a) Short Title.--This title may be cited as the ``Animal Drug User 
Fee Amendments of 2013''.
    (b) Finding.--Congress finds that the fees authorized by the 
amendments made in this title will be dedicated toward expediting the 
animal drug development process and the review of new and supplemental 
animal drug applications and investigational animal drug submissions as 
set forth in the goals identified, for purposes of part 4 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the 
letters from the Secretary of Health and Human Services to the Chairman 
of the Committee on Energy and Commerce of the House of Representatives 
and the Chairman of the Committee on Health, Education, Labor, and 
Pensions of the Senate as set forth in the Congressional Record.

SEC. 102. DEFINITIONS.

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

``SEC. 739. DEFINITIONS.

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

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

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

``SEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.

    ``(a) Types of Fees.--Beginning in fiscal year 2004, the Secretary 
shall assess and collect fees in accordance with this section as 
follows:
            ``(1) Animal drug application and supplement fee.--
                    ``(A) In general.--Each person that submits, on or 
                after September 1, 2003, an animal drug application or 
                a supplemental animal drug application shall be subject 
                to a fee as follows:
                            ``(i) A fee established in subsection (c) 
                        for an animal drug application, except an 
                        animal drug application subject to the criteria 
                        set forth in section 512(d)(4).
                            ``(ii) A fee established in subsection (c), 
                        in an amount that is equal to 50 percent of the 
                        amount of the fee under clause (i), for--
                                    ``(I) a supplemental animal drug 
                                application for which safety or 
                                effectiveness data are required; and
                                    ``(II) an animal drug application 
                                subject to the criteria set forth in 
                                section 512(d)(4).
                    ``(B) Payment.--The fee required by subparagraph 
                (A) shall be due upon submission of the animal drug 
                application or supplemental animal drug application.
                    ``(C) Exception for previously filed application or 
                supplement.--If an animal drug application or a 
                supplemental animal drug application was submitted by a 
                person that paid the fee for such application or 
                supplement, was accepted for filing, and was not 
                approved or was withdrawn (without a waiver or refund), 
                the submission of an animal drug application or a 
                supplemental animal drug application for the same 
                product by the same person (or the person's licensee, 
                assignee, or successor) shall not be subject to a fee 
                under subparagraph (A).
                    ``(D) Refund of fee if application refused for 
                filing.--The Secretary shall refund 75 percent of the 
                fee paid under subparagraph (B) for any animal drug 
                application or supplemental animal drug application 
                which is refused for filing.
                    ``(E) Refund of fee if application withdrawn.--If 
                an animal drug application or a supplemental animal 
                drug application is withdrawn after the application or 
                supplement was filed, the Secretary may refund the fee 
                or portion of the fee paid under subparagraph (B) if no 
                substantial work was performed on the application or 
                supplement after the application or supplement was 
                filed. The Secretary shall have the sole discretion to 
                refund the fee under this paragraph. A determination by 
                the Secretary concerning a refund under this paragraph 
                shall not be reviewable.
            ``(2) Animal drug product fee.--
                    ``(A) In general.--Each person--
                            ``(i) who is named as the applicant in an 
                        animal drug application or supplemental animal 
                        drug application for an animal drug product 
                        which has been submitted for listing under 
                        section 510; and
                            ``(ii) who, after September 1, 2003, had 
                        pending before the Secretary an animal drug 
                        application or supplemental animal drug 
                        application,
                shall pay for each such animal drug product the annual 
                fee established in subsection (c).
                    ``(B) Payment; fee due date.--Such fee shall be 
                payable for the fiscal year in which the animal drug 
                product is first submitted for listing under section 
                510, or is submitted for relisting under section 510 if 
                the animal drug product has been withdrawn from listing 
                and relisted. After such fee is paid for that fiscal 
                year, such fee shall be due each subsequent fiscal year 
                that the product remains listed, upon the later of--
                            ``(i) the first business day after the date 
                        of enactment of an appropriations Act providing 
                        for the collection and obligation of fees for 
                        such fiscal year under this section; or
                            ``(ii) January 31 of each year.
                    ``(C) Limitation.--Such fee shall be paid only once 
                for each animal drug product for a fiscal year in which 
                the fee is payable.
            ``(3) Animal drug establishment fee.--
                    ``(A) In general.--Each person--
                            ``(i) who owns or operates, directly or 
                        through an affiliate, an animal drug 
                        establishment;
                            ``(ii) who is named as the applicant in an 
                        animal drug application or supplemental animal 
                        drug application for an animal drug product 
                        which has been submitted for listing under 
                        section 510; and
                            ``(iii) who, after September 1, 2003, had 
                        pending before the Secretary an animal drug 
                        application or supplemental animal drug 
                        application,
                shall be assessed an annual establishment fee as 
                established in subsection (c) for each animal drug 
                establishment listed in its approved animal drug 
                application as an establishment that manufactures the 
                animal drug product named in the application.
                    ``(B) Payment; fee due date.--The annual 
                establishment fee shall be assessed in each fiscal year 
                in which the animal drug product named in the 
                application is assessed a fee under paragraph (2) 
                unless the animal drug establishment listed in the 
                application does not engage in the manufacture of the 
                animal drug product during the fiscal year. The fee 
                under this paragraph for a fiscal year shall be due 
                upon the later of--
                            ``(i) the first business day after the date 
                        of enactment of an appropriations Act providing 
                        for the collection and obligation of fees for 
                        such fiscal year under this section; or
                            ``(ii) January 31 of each year.
                    ``(C) Limitation.--
                            ``(i) In general.--An establishment shall 
                        be assessed only one fee per fiscal year under 
                        this section, subject to clause (ii).
                            ``(ii) Certain manufacturers.--If a single 
                        establishment manufactures both animal drug 
                        products and prescription drug products, as 
                        defined in section 735(3), such establishment 
                        shall be assessed both the animal drug 
                        establishment fee and the prescription drug 
                        establishment fee, as set forth in section 
                        736(a)(2), within a single fiscal year.
            ``(4) Animal drug sponsor fee.--
                    ``(A) In general.--Each person--
                            ``(i) who meets the definition of an animal 
                        drug sponsor within a fiscal year; and
                            ``(ii) who, after September 1, 2003, had 
                        pending before the Secretary an animal drug 
                        application, a supplemental animal drug 
                        application, or an investigational animal drug 
                        submission,
                shall be assessed an annual sponsor fee as established 
                under subsection (c).
                    ``(B) Payment; fee due date.--The fee under this 
                paragraph for a fiscal year shall be due upon the later 
                of--
                            ``(i) the first business day after the date 
                        of enactment of an appropriations Act providing 
                        for the collection and obligation of fees for 
                        such fiscal year under this section; or
                            ``(ii) January 31 of each year.
                    ``(C) Limitation.--Each animal drug sponsor shall 
                pay only one such fee each fiscal year.
    ``(b) Fee Revenue Amounts.--
            ``(1) In general.--Subject to subsections (c), (d), (f), 
        and (g)--
                    ``(A) for fiscal year 2014, the fees required under 
                subsection (a) shall be established to generate a total 
                revenue amount of $23,600,000; and
                    ``(B) for each of fiscal years 2015 through 2018, 
                the fees required under subsection (a) shall be 
                established to generate a total revenue amount of 
                $21,600,000.
            ``(2) Types of fees.--Of the total revenue amount 
        determined for a fiscal year under paragraph (1)--
                    ``(A) 20 percent shall be derived from fees under 
                subsection (a)(1) (relating to animal drug applications 
                and supplements);
                    ``(B) 27 percent shall be derived from fees under 
                subsection (a)(2) (relating to animal drug products);
                    ``(C) 26 percent shall be derived from fees under 
                subsection (a)(3) (relating to animal drug 
                establishments); and
                    ``(D) 27 percent shall be derived from fees under 
                subsection (a)(4) (relating to animal drug sponsors).
    ``(c) Annual Fee Setting; Adjustments.--
            ``(1) Annual fee setting.--The Secretary shall establish, 
        60 days before the start of each fiscal year beginning after 
        September 30, 2003, for that fiscal year, animal drug 
        application fees, supplemental animal drug application fees, 
        animal drug sponsor fees, animal drug establishment fees, and 
        animal drug product fees based on the revenue amounts 
        established under subsection (b) and the adjustments provided 
        under this subsection.
            ``(2) Inflation adjustment.--For fiscal year 2015 and 
        subsequent fiscal years, the revenue amounts established in 
        subsection (b) shall be adjusted by the Secretary by notice, 
        published in the Federal Register, for a fiscal year, by an 
        amount equal to the sum of--
                    ``(A) one;
                    ``(B) the average annual percent change in the 
                cost, per full-time equivalent position of the Food and 
                Drug Administration, of all personnel compensation and 
                benefits paid with respect to such positions for the 
                first 3 of the preceding 4 fiscal years for which data 
                are available, multiplied by the average proportion of 
                personnel compensation and benefits costs to total Food 
                and Drug Administration costs for the first 3 years of 
                the preceding 4 fiscal years for which data are 
                available; and
                    ``(C) the average annual percent change that 
                occurred in the Consumer Price Index for urban 
                consumers (Washington-Baltimore, DC-MD-VA-WV; not 
                seasonally adjusted; all items less food and energy; 
                annual index) for the first 3 years of the preceding 4 
                years for which data are available multiplied by the 
                average proportion of all costs other than personnel 
                compensation and benefits costs to total Food and Drug 
                Administration costs for the first 3 years of the 
                preceding 4 fiscal years for which data are available.
        The adjustment made each fiscal year under this paragraph shall 
        be added on a compounded basis to the sum of all adjustments 
        made each fiscal year after fiscal year 2014 under this 
        paragraph.
            ``(3) Workload adjustment.--For fiscal year 2015 and 
        subsequent fiscal years, after the revenue amounts established 
        in subsection (b) are adjusted for inflation in accordance with 
        paragraph (2), the revenue amounts shall be further adjusted 
        for such fiscal year to reflect changes in the workload of the 
        Secretary for the process for the review of animal drug 
        applications. With respect to such adjustment--
                    ``(A) such adjustment shall be determined by the 
                Secretary based on a weighted average of the change in 
                the total number of animal drug applications, 
                supplemental animal drug applications for which data 
                with respect to safety or effectiveness are required, 
                manufacturing supplemental animal drug applications, 
                investigational animal drug study submissions, and 
                investigational animal drug protocol submissions 
                submitted to the Secretary;
                    ``(B) the Secretary shall publish in the Federal 
                Register the fees resulting from such adjustment and 
                the supporting methodologies; and
                    ``(C) under no circumstances shall such adjustment 
                result in fee revenues for a fiscal year that are less 
                than the fee revenues for that fiscal year established 
                in subsection (b), as adjusted for inflation under 
                paragraph (2).
            ``(4) Final year adjustment.--For fiscal year 2018, the 
        Secretary may, in addition to other adjustments under this 
        subsection, further increase the fees under this section, if 
        such an adjustment is necessary, to provide for up to 3 months 
        of operating reserves of carryover user fees for the process 
        for the review of animal drug applications for the first 3 
        months of fiscal year 2019. If the Food and Drug Administration 
        has carryover balances for the process for the review of animal 
        drug applications in excess of 3 months of such operating 
        reserves, then this adjustment will not be made. If this 
        adjustment is necessary, then the rationale for the amount of 
        the increase shall be contained in the annual notice setting 
        fees for fiscal year 2018.
            ``(5) Limit.--The total amount of fees charged, as adjusted 
        under this subsection, for a fiscal year may not exceed the 
        total costs for such fiscal year for the resources allocated 
        for the process for the review of animal drug applications.
    ``(d) Fee Waiver or Reduction.--
            ``(1) In general.--The Secretary shall grant a waiver from 
        or a reduction of one or more fees assessed under subsection 
        (a) where the Secretary finds that--
                    ``(A) the assessment of the fee would present a 
                significant barrier to innovation because of limited 
                resources available to such person or other 
                circumstances;
                    ``(B) the fees to be paid by such person will 
                exceed the anticipated present and future costs 
                incurred by the Secretary in conducting the process for 
                the review of animal drug applications for such person;
                    ``(C) the animal drug application or supplemental 
                animal drug application is intended solely to provide 
                for use of the animal drug in--
                            ``(i) a Type B medicated feed (as defined 
                        in section 558.3(b)(3) of title 21, Code of 
                        Federal Regulations (or any successor 
                        regulation)) intended for use in the 
                        manufacture of Type C free-choice medicated 
                        feeds; or
                            ``(ii) a Type C free-choice medicated feed 
                        (as defined in section 558.3(b)(4) of title 21, 
                        Code of Federal Regulations (or any successor 
                        regulation));
                    ``(D) the animal drug application or supplemental 
                animal drug application is intended solely to provide 
                for a minor use or minor species indication; or
                    ``(E) the sponsor involved is a small business 
                submitting its first animal drug application to the 
                Secretary for review.
            ``(2) Use of standard costs.--In making the finding in 
        paragraph (1)(B), the Secretary may use standard costs.
            ``(3) Rules for small businesses.--
                    ``(A) Definition.--In paragraph (1)(E), the term 
                `small business' means an entity that has fewer than 
                500 employees, including employees of affiliates.
                    ``(B) Waiver of application fee.--The Secretary 
                shall waive under paragraph (1)(E) the application fee 
                for the first animal drug application that a small 
                business or its affiliate submits to the Secretary for 
                review. After a small business or its affiliate is 
                granted such a waiver, the small business or its 
                affiliate shall pay application fees for all subsequent 
                animal drug applications and supplemental animal drug 
                applications for which safety or effectiveness data are 
                required in the same manner as an entity that does not 
                qualify as a small business.
                    ``(C) Certification.--The Secretary shall require 
                any person who applies for a waiver under paragraph 
                (1)(E) to certify their qualification for the waiver. 
                The Secretary shall periodically publish in the Federal 
                Register a list of persons making such certifications.
    ``(e) Effect of Failure To Pay Fees.--An animal drug application or 
supplemental animal drug application submitted by a person subject to 
fees under subsection (a) shall be considered incomplete and shall not 
be accepted for filing by the Secretary until all fees owed by such 
person have been paid. An investigational animal drug submission under 
section 739(5)(B) that is submitted by a person subject to fees under 
subsection (a) shall be considered incomplete and shall not be accepted 
for review by the Secretary until all fees owed by such person have 
been paid. The Secretary may discontinue review of any animal drug 
application, supplemental animal drug application or investigational 
animal drug submission from a person if such person has not submitted 
for payment all fees owed under this section by 30 days after the date 
upon which they are due.
    ``(f) Assessment of Fees.--
            ``(1) Limitation.--Fees may not be assessed under 
        subsection (a) for a fiscal year beginning after fiscal year 
        2003 unless appropriations for salaries and expenses of the 
        Food and Drug Administration for such fiscal year (excluding 
        the amount of fees appropriated for such fiscal year) are equal 
        to or greater than the amount of appropriations for the 
        salaries and expenses of the Food and Drug Administration for 
        the fiscal year 2003 (excluding the amount of fees appropriated 
        for such fiscal year) multiplied by the adjustment factor 
        applicable to the fiscal year involved.
            ``(2) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal year 
        because of paragraph (1) and if at a later date in such fiscal 
        year the Secretary may assess such fees, the Secretary may 
        assess and collect such fees, without any modification in the 
        rate, for animal drug applications, supplemental animal drug 
        applications, investigational animal drug submissions, animal 
        drug sponsors, animal drug establishments and animal drug 
        products at any time in such fiscal year notwithstanding the 
        provisions of subsection (a) relating to the date fees are to 
        be paid.
    ``(g) Crediting and Availability of Fees.--
            ``(1) In general.--Subject to paragraph (2)(C), fees 
        authorized under subsection (a) shall be collected and 
        available for obligation only to the extent and in the amount 
        provided in advance in appropriations Acts. Such fees are 
        authorized to be appropriated to remain available until 
        expended. Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salary and expenses with such fiscal 
        year limitation. The sums transferred shall be available solely 
        for the process for the review of animal drug applications.
            ``(2) Collections and appropriation acts.--
                    ``(A) In general.--The fees authorized by this 
                section--
                            ``(i) subject to subparagraph (C), shall be 
                        collected and available in each fiscal year in 
                        an amount not to exceed the amount specified in 
                        appropriation Acts, or otherwise made available 
                        for obligation for such fiscal year, and
                            ``(ii) shall be available to defray 
                        increases in the costs of the resources 
                        allocated for the process for the review of 
                        animal drug applications (including increases 
                        in such costs for an additional number of full-
                        time equivalent positions in the Department of 
                        Health and Human Services to be engaged in such 
                        process) over such costs, excluding costs paid 
                        from fees collected under this section, for 
                        fiscal year 2003 multiplied by the adjustment 
                        factor.
                    ``(B) Compliance.--The Secretary shall be 
                considered to have met the requirements of subparagraph 
                (A)(ii) in any fiscal year if the costs funded by 
                appropriations and allocated for the process for the 
                review of animal drug applications--
                            ``(i) are not more than 3 percent below the 
                        level specified in subparagraph (A)(ii); or
                            ``(ii)(I) are more than 3 percent below the 
                        level specified in subparagraph (A)(ii), and 
                        fees assessed for the fiscal year following the 
                        subsequent fiscal year are decreased by the 
                        amount in excess of 3 percent by which such 
                        costs fell below the level specified in 
                        subparagraph (A)(ii); and
                            ``(II) such costs are not more than 5 
                        percent below the level specified in 
                        subparagraph (A)(ii).
                    ``(C) Provision for early payments.--Payment of 
                fees authorized under this section for a fiscal year, 
                prior to the due date for such fees, may be accepted by 
                the Secretary in accordance with authority provided in 
                advance in a prior year appropriations Act.
            ``(3) Authorization of appropriations.--For each of the 
        fiscal years 2014 through 2018, there is authorized to be 
        appropriated for fees under this section an amount equal to the 
        total revenue amount determined under subsection (b) for the 
        fiscal year, as adjusted or otherwise affected under subsection 
        (c) and paragraph (4).
            ``(4) Offset of overcollections; recovery of collection 
        shortfalls.--
                    ``(A) Offset of overcollections.--If the sum of the 
                cumulative amount of fees collected under this section 
                for fiscal years 2014 through 2016 and the amount of 
                fees estimated to be collected under this section for 
                fiscal year 2017 (including any increased fee 
                collections attributable to subparagraph (B)), exceeds 
                the cumulative amount appropriated pursuant to 
                paragraph (3) for the fiscal years 2014 through 2017, 
                the excess amount shall be credited to the 
                appropriation account of the Food and Drug 
                Administration as provided in paragraph (1), and shall 
                be subtracted from the amount of fees that would 
                otherwise be authorized to be collected under this 
                section pursuant to appropriation Acts for fiscal year 
                2018.
                    ``(B) Recovery of collection shortfalls.--
                            ``(i) Fiscal year 2016.--For fiscal year 
                        2016, the amount of fees otherwise authorized 
                        to be collected under this section shall be 
                        increased by the amount, if any, by which the 
                        amount collected under this section and 
                        appropriated for fiscal year 2014 falls below 
                        the amount of fees authorized for fiscal year 
                        2014 under paragraph (3).
                            ``(ii) Fiscal year 2017.--For fiscal year 
                        2017, the amount of fees otherwise authorized 
                        to be collected under this section shall be 
                        increased by the amount, if any, by which the 
                        amount collected under this section and 
                        appropriated for fiscal year 2015 falls below 
                        the amount of fees authorized for fiscal year 
                        2015 under paragraph (3).
                            ``(iii) Fiscal year 2018.--For fiscal year 
                        2018, the amount of fees otherwise authorized 
                        to be collected under this section (including 
                        any reduction in the authorized amount under 
                        subparagraph (A)), shall be increased by the 
                        cumulative amount, if any, by which the amount 
                        collected under this section and appropriated 
                        for fiscal years 2016 and 2017 (including 
                        estimated collections for fiscal year 2017) 
                        falls below the cumulative amount of fees 
                        authorized under paragraph (3) for fiscal years 
                        2016 and 2017.
    ``(h) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a fee assessed under subsection (a) within 
30 days after it is due, such fee shall be treated as a claim of the 
United States Government subject to subchapter II of chapter 37 of 
title 31, United States Code.
    ``(i) Written Requests for Waivers, Reductions, and Refunds.--To 
qualify for consideration for a waiver or reduction under subsection 
(d), or for a refund of any fee collected in accordance with subsection 
(a), a person shall submit to the Secretary a written request for such 
waiver, reduction, or refund not later than 180 days after such fee is 
due.
    ``(j) Construction.--This section may not be construed to require 
that the number of full-time equivalent positions in the Department of 
Health and Human Services, for officers, employees, and advisory 
committees not engaged in the process of the review of animal drug 
applications, be reduced to offset the number of officers, employees, 
and advisory committees so engaged.
    ``(k) Abbreviated New Animal Drug Applications.--The Secretary 
shall--
            ``(1) to the extent practicable, segregate the review of 
        abbreviated new animal drug applications from the process for 
        the review of animal drug applications; and
            ``(2) adopt other administrative procedures to ensure that 
        review times of abbreviated new animal drug applications do not 
        increase from their current level due to activities under the 
        user fee program.''.

SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.

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

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

    ``(a) Performance Report.--Beginning with fiscal year 2014, not 
later than 120 days after the end of each fiscal year during which fees 
are collected under this part, the Secretary shall prepare and submit 
to the Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives a report concerning the progress of the Food and Drug 
Administration in achieving the goals identified in the letters 
described in section 101(b) of the Animal Drug User Fee Amendments of 
2013 toward expediting the animal drug development process and the 
review of the new and supplemental animal drug applications and 
investigational animal drug submissions during such fiscal year, the 
future plans of the Food and Drug Administration for meeting the goals, 
the review times for abbreviated new animal drug applications, and the 
administrative procedures adopted by the Food and Drug Administration 
to ensure that review times for abbreviated new animal drug 
applications are not increased from their current level due to 
activities under the user fee program.
    ``(b) Fiscal Report.--Beginning with fiscal year 2014, not later 
than 120 days after the end of each fiscal year during which fees are 
collected under this part, the Secretary shall prepare and submit to 
the Committee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives a report on the implementation of the authority for 
such fees during such fiscal year and the use, by the Food and Drug 
Administration, of the fees collected during such fiscal year for which 
the report is made.
    ``(c) Public Availability.--The Secretary shall make the reports 
required under subsections (a) and (b) available to the public on the 
Internet Web site of the Food and Drug Administration.
    ``(d) Reauthorization.--
            ``(1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals, and plans 
        for meeting the goals, for the process for the review of animal 
        drug applications for the first 5 fiscal years after fiscal 
        year 2018, and for the reauthorization of this part for such 
        fiscal years, the Secretary shall consult with--
                    ``(A) the Committee on Health, Education, Labor, 
                and Pensions of the Senate;
                    ``(B) the Committee on Energy and Commerce of the 
                House of Representatives;
                    ``(C) scientific and academic experts;
                    ``(D) veterinary professionals;
                    ``(E) representatives of patient and consumer 
                advocacy groups; and
                    ``(F) the regulated industry.
            ``(2) Prior public input.--Prior to beginning negotiations 
        with the regulated industry on the reauthorization of this 
        part, the Secretary shall--
                    ``(A) publish a notice in the Federal Register 
                requesting public input on the reauthorization;
                    ``(B) hold a public meeting at which the public may 
                present its views on the reauthorization, including 
                specific suggestions for changes to the goals referred 
                to in subsection (a);
                    ``(C) provide a period of 30 days after the public 
                meeting to obtain written comments from the public 
                suggesting changes to this part; and
                    ``(D) publish the comments on the Food and Drug 
                Administration's Internet Web site.
            ``(3) Periodic consultation.--Not less frequently than once 
        every 4 months during negotiations with the regulated industry, 
        the Secretary shall hold discussions with representatives of 
        veterinary, patient, and consumer advocacy groups to continue 
        discussions of their views on the reauthorization and their 
        suggestions for changes to this part as expressed under 
        paragraph (2).
            ``(4) Public review of recommendations.--After negotiations 
        with the regulated industry, the Secretary shall--
                    ``(A) present the recommendations developed under 
                paragraph (1) to the Congressional committees specified 
                in such paragraph;
                    ``(B) publish such recommendations in the Federal 
                Register;
                    ``(C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                    ``(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                    ``(E) after consideration of such public views and 
                comments, revise such recommendations as necessary.
            ``(5) Transmittal of recommendations.--Not later than 
        January 15, 2018, the Secretary shall transmit to Congress the 
        revised recommendations under paragraph (4) a summary of the 
        views and comments received under such paragraph, and any 
        changes made to the recommendations in response to such views 
        and comments.
            ``(6) Minutes of negotiation meetings.--
                    ``(A) Public availability.--Before presenting the 
                recommendations developed under paragraphs (1) through 
                (5) to Congress, the Secretary shall make publicly 
                available, on the Internet Web site of the Food and 
                Drug Administration, minutes of all negotiation 
                meetings conducted under this subsection between the 
                Food and Drug Administration and the regulated 
                industry.
                    ``(B) Content.--The minutes described under 
                subparagraph (A) shall summarize any substantive 
                proposal made by any party to the negotiations as well 
                as significant controversies or differences of opinion 
                during the negotiations and their resolution.''.

SEC. 105. SAVINGS CLAUSE.

    Notwithstanding the amendments made by this title, part 4 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j-11 et seq.), as in effect on the day before the date of 
the enactment of this title, shall continue to be in effect with 
respect to animal drug applications and supplemental animal drug 
applications (as defined in such part as of such day) that on or after 
October 1, 2008, but before October 1, 2013, were accepted by the Food 
and Drug Administration for filing with respect to assessing and 
collecting any fee required by such part for a fiscal year prior to 
fiscal year 2014.

SEC. 106. EFFECTIVE DATE.

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

SEC. 107. SUNSET DATES.

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

            TITLE II--FEES RELATING TO GENERIC ANIMAL DRUGS

SEC. 201. SHORT TITLE; FINDING.

    (a) Short Title.--This title may be cited as the ``Animal Generic 
Drug User Fee Amendments of 2013''.
    (b) Finding.--The fees authorized by this title will be dedicated 
toward expediting the generic new animal drug development process and 
the review of abbreviated applications for generic new animal drugs, 
supplemental abbreviated applications for generic new animal drugs, and 
investigational submissions for generic new animal drugs as set forth 
in the goals identified in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee on Energy and Commerce 
of the House of Representatives and the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate as set forth in 
the Congressional Record.

SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES.

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

``SEC. 741. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES.

    ``(a) Types of Fees.--Beginning with respect to fiscal year 2009, 
the Secretary shall assess and collect fees in accordance with this 
section as follows:
            ``(1) Abbreviated application fee.--
                    ``(A) In general.--Each person that submits, on or 
                after July 1, 2008, an abbreviated application for a 
                generic new animal drug shall be subject to a fee as 
                established in subsection (c) for such an application.
                    ``(B) Payment.--The fee required by subparagraph 
                (A) shall be due upon submission of the abbreviated 
                application.
                    ``(C) Exceptions.--
                            ``(i) Previously filed application.--If an 
                        abbreviated application was submitted by a 
                        person that paid the fee for such application, 
                        was accepted for filing, and was not approved 
                        or was withdrawn (without a waiver or refund), 
                        the submission of an abbreviated application 
                        for the same product by the same person (or the 
                        person's licensee, assignee, or successor) 
                        shall not be subject to a fee under 
                        subparagraph (A).
                            ``(ii) Certain abbreviated applications 
                        involving combination animal drugs.--An 
                        abbreviated application which is subject to the 
                        criteria in section 512(d)(4) and submitted on 
                        or after October 1, 2013 shall be subject to a 
                        fee equal to 50 percent of the amount of the 
                        abbreviated application fee established in 
                        subsection (c).
                    ``(D) Refund of fee if application refused for 
                filing.--The Secretary shall refund 75 percent of the 
                fee paid under subparagraph (B) for any abbreviated 
                application which is refused for filing.
                    ``(E) Refund of fee if application withdrawn.--If 
                an abbreviated application is withdrawn after the 
                application was filed, the Secretary may refund the fee 
                or portion of the fee paid under subparagraph (B) if no 
                substantial work was performed on the application after 
                the application was filed. The Secretary shall have the 
                sole discretion to refund the fee under this 
                subparagraph. A determination by the Secretary 
                concerning a refund under this subparagraph shall not 
                be reviewable.
            ``(2) Generic new animal drug product fee.--
                    ``(A) In general.--Each person--
                            ``(i) who is named as the applicant in an 
                        abbreviated application or supplemental 
                        abbreviated application for a generic new 
                        animal drug product which has been submitted 
                        for listing under section 510; and
                            ``(ii) who, after September 1, 2008, had 
                        pending before the Secretary an abbreviated 
                        application or supplemental abbreviated 
                        application,
                shall pay for each such generic new animal drug product 
                the annual fee established in subsection (c).
                    ``(B) Payment; fee due date.--Such fee shall be 
                payable for the fiscal year in which the generic new 
                animal drug product is first submitted for listing 
                under section 510, or is submitted for relisting under 
                section 510 if the generic new animal drug product has 
                been withdrawn from listing and relisted. After such 
                fee is paid for that fiscal year, such fee shall be due 
                each subsequent fiscal year that the product remains 
                listed, upon the later of--
                            ``(i) the first business day after the date 
                        of enactment of an appropriations Act providing 
                        for the collection and obligation of fees for 
                        such fiscal year under this section; or
                            ``(ii) January 31 of each year.
                    ``(C) Limitation.--Such fee shall be paid only once 
                for each generic new animal drug product for a fiscal 
                year in which the fee is payable.
            ``(3) Generic new animal drug sponsor fee.--
                    ``(A) In general.--Each person--
                            ``(i) who meets the definition of a generic 
                        new animal drug sponsor within a fiscal year; 
                        and
                            ``(ii) who, after September 1, 2008, had 
                        pending before the Secretary an abbreviated 
                        application, a supplemental abbreviated 
                        application, or an investigational submission,
                shall be assessed an annual generic new animal drug 
                sponsor fee as established under subsection (c).
                    ``(B) Payment; fee due date.--Such fee shall be due 
                each fiscal year upon the later of--
                            ``(i) the first business day after the date 
                        of enactment of an appropriations Act providing 
                        for the collection and obligation of fees for 
                        such fiscal year under this section; or
                            ``(ii) January 31 of each year.
                    ``(C) Amount of fee.--Each generic new animal drug 
                sponsor shall pay only 1 such fee each fiscal year, as 
                follows:
                            ``(i) 100 percent of the amount of the 
                        generic new animal drug sponsor fee published 
                        for that fiscal year under subsection (c) for 
                        an applicant with more than 6 approved 
                        abbreviated applications.
                            ``(ii) 75 percent of the amount of the 
                        generic new animal drug sponsor fee published 
                        for that fiscal year under subsection (c) for 
                        an applicant with more than 1 and fewer than 7 
                        approved abbreviated applications.
                            ``(iii) 50 percent of the amount of the 
                        generic new animal drug sponsor fee published 
                        for that fiscal year under subsection (c) for 
                        an applicant with 1 or fewer approved 
                        abbreviated applications.
    ``(b) Fee Amounts.--Subject to subsections (c), (d), (f), and (g), 
the fees required under subsection (a) shall be established to generate 
fee revenue amounts as follows:
            ``(1) Total fee revenues for application fees.--The total 
        fee revenues to be collected in abbreviated application fees 
        under subsection (a)(1) shall be $1,832,000 for fiscal year 
        2014, $1,736,000 for fiscal year 2015, $1,857,000 for fiscal 
        year 2016, $1,984,000 for fiscal year 2017, and $2,117,000 for 
        fiscal year 2018.
            ``(2) Total fee revenues for product fees.--The total fee 
        revenues to be collected in generic new animal drug product 
        fees under subsection (a)(2) shall be $2,748,000 for fiscal 
        year 2014, $2,604,000 for fiscal year 2015, $2,786,000 for 
        fiscal year 2016, $2,976,000 for fiscal year 2017, and 
        $3,175,000 for fiscal year 2018.
            ``(3) Total fee revenues for sponsor fees.--The total fee 
        revenues to be collected in generic new animal drug sponsor 
        fees under subsection (a)(3) shall be $2,748,000 for fiscal 
        year 2014, $2,604,000 for fiscal year 2015, $2,786,000 for 
        fiscal year 2016, $2,976,000 for fiscal year 2017, and 
        $3,175,000 for fiscal year 2018.
    ``(c) Annual Fee Setting; Adjustments.--
            ``(1) Annual fee setting.--The Secretary shall establish, 
        60 days before the start of each fiscal year beginning after 
        September 30, 2008, for that fiscal year, abbreviated 
        application fees, generic new animal drug sponsor fees, and 
        generic new animal drug product fees, based on the revenue 
        amounts established under subsection (b) and the adjustments 
        provided under this subsection.
            ``(2) Workload adjustment.--The fee revenues shall be 
        adjusted each fiscal year after fiscal year 2014 to reflect 
        changes in review workload. With respect to such adjustment:
                    ``(A) This adjustment shall be determined by the 
                Secretary based on a weighted average of the change in 
                the total number of abbreviated applications for 
                generic new animal drugs, manufacturing supplemental 
                abbreviated applications for generic new animal drugs, 
                investigational generic new animal drug study 
                submissions, and investigational generic new animal 
                drug protocol submissions submitted to the Secretary. 
                The Secretary shall publish in the Federal Register the 
                fees resulting from this adjustment and the supporting 
                methodologies.
                    ``(B) Under no circumstances shall this workload 
                adjustment result in fee revenues for a fiscal year 
                that are less than the fee revenues for that fiscal 
                year established in subsection (b).
            ``(3) Final year adjustment.--For fiscal year 2018, the 
        Secretary may, in addition to other adjustments under this 
        subsection, further increase the fees under this section, if 
        such an adjustment is necessary, to provide for up to 3 months 
        of operating reserves of carryover user fees for the process 
        for the review of abbreviated applications for generic new 
        animal drugs for the first 3 months of fiscal year 2019. If the 
        Food and Drug Administration has carryover balances for the 
        process for the review of abbreviated applications for generic 
        new animal drugs in excess of 3 months of such operating 
        reserves, then this adjustment shall not be made. If this 
        adjustment is necessary, then the rationale for the amount of 
        the increase shall be contained in the annual notice setting 
        fees for fiscal year 2018.
            ``(4) Limit.--The total amount of fees charged, as adjusted 
        under this subsection, for a fiscal year may not exceed the 
        total costs for such fiscal year for the resources allocated 
        for the process for the review of abbreviated applications for 
        generic new animal drugs.
    ``(d) Fee Waiver or Reduction.--The Secretary shall grant a waiver 
from or a reduction of 1 or more fees assessed under subsection (a) 
where the Secretary finds that the generic new animal drug is intended 
solely to provide for a minor use or minor species indication.
    ``(e) Effect of Failure to Pay Fees.--An abbreviated application 
for a generic new animal drug submitted by a person subject to fees 
under subsection (a) shall be considered incomplete and shall not be 
accepted for filing by the Secretary until all fees owed by such person 
have been paid. An investigational submission for a generic new animal 
drug that is submitted by a person subject to fees under subsection (a) 
shall be considered incomplete and shall not be accepted for review by 
the Secretary until all fees owed by such person have been paid. The 
Secretary may discontinue review of any abbreviated application for a 
generic new animal drug, supplemental abbreviated application for a 
generic new animal drug, or investigational submission for a generic 
new animal drug from a person if such person has not submitted for 
payment all fees owed under this section by 30 days after the date upon 
which they are due.
    ``(f) Assessment of Fees.--
            ``(1) Limitation.--Fees may not be assessed under 
        subsection (a) for a fiscal year beginning after fiscal year 
        2008 unless appropriations for salaries and expenses of the 
        Food and Drug Administration for such fiscal year (excluding 
        the amount of fees appropriated for such fiscal year) are equal 
        to or greater than the amount of appropriations for the 
        salaries and expenses of the Food and Drug Administration for 
        the fiscal year 2003 (excluding the amount of fees appropriated 
        for such fiscal year) multiplied by the adjustment factor 
        applicable to the fiscal year involved.
            ``(2) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal year 
        because of paragraph (1) and if at a later date in such fiscal 
        year the Secretary may assess such fees, the Secretary may 
        assess and collect such fees, without any modification in the 
        rate, for abbreviated applications, generic new animal drug 
        sponsors, and generic new animal drug products at any time in 
        such fiscal year notwithstanding the provisions of subsection 
        (a) relating to the date fees are to be paid.
    ``(g) Crediting and Availability of Fees.--
            ``(1) In general.--Subject to paragraph (2)(C), fees 
        authorized under subsection (a) shall be collected and 
        available for obligation only to the extent and in the amount 
        provided in advance in appropriations Acts. Such fees are 
        authorized to be appropriated to remain available until 
        expended. Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salary and expenses with such fiscal 
        year limitation. The sums transferred shall be available solely 
        for the process for the review of abbreviated applications for 
        generic new animal drugs.
            ``(2) Collections and appropriation acts.--
                    ``(A) In general.--The fees authorized by this 
                section--
                            ``(i) subject to subparagraph (C), shall be 
                        collected and available in each fiscal year in 
                        an amount not to exceed the amount specified in 
                        appropriation Acts, or otherwise made available 
                        for obligation for such fiscal year; and
                            ``(ii) shall be available to defray 
                        increases in the costs of the resources 
                        allocated for the process for the review of 
                        abbreviated applications for generic new animal 
                        drugs (including increases in such costs for an 
                        additional number of full-time equivalent 
                        positions in the Department of Health and Human 
                        Services to be engaged in such process) over 
                        such costs, excluding costs paid from fees 
                        collected under this section, for fiscal year 
                        2008 multiplied by the adjustment factor.
                    ``(B) Compliance.--The Secretary shall be 
                considered to have met the requirements of subparagraph 
                (A)(ii) in any fiscal year if the costs funded by 
                appropriations and allocated for the process for the 
                review of abbreviated applications for generic new 
                animal drugs--
                            ``(i) are not more than 3 percent below the 
                        level specified in subparagraph (A)(ii); or
                            ``(ii)(I) are more than 3 percent below the 
                        level specified in subparagraph (A)(ii), and 
                        fees assessed for the fiscal year following the 
                        subsequent fiscal year are decreased by the 
                        amount in excess of 3 percent by which such 
                        costs fell below the level specified in 
                        subparagraph (A)(ii); and
                            ``(II) such costs are not more than 5 
                        percent below the level specified in 
                        subparagraph (A)(ii).
                    ``(C) Provision for early payments.--Payment of 
                fees authorized under this section for a fiscal year, 
                prior to the due date for such fees, may be accepted by 
                the Secretary in accordance with authority provided in 
                advance in a prior year appropriations Act.
            ``(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this section--
                    ``(A) $7,328,000 for fiscal year 2014;
                    ``(B) $6,944,000 for fiscal year 2015;
                    ``(C) $7,429,000 for fiscal year 2016;
                    ``(D) $7,936,000 for fiscal year 2017; and
                    ``(E) $8,467,000 for fiscal year 2018;
        as adjusted to reflect adjustments in the total fee revenues 
        made under this section and changes in the total amounts 
        collected by abbreviated application fees, generic new animal 
        drug sponsor fees, and generic new animal drug product fees.
            ``(4) Offset.--If the sum of the cumulative amount of fees 
        collected under this section for the fiscal years 2014 through 
        2016 and the amount of fees estimated to be collected under 
        this section for fiscal year 2017 exceeds the cumulative amount 
        appropriated under paragraph (3) for the fiscal years 2014 
        through 2017, the excess amount shall be credited to the 
        appropriation account of the Food and Drug Administration as 
        provided in paragraph (1), and shall be subtracted from the 
        amount of fees that would otherwise be authorized to be 
        collected under this section pursuant to appropriation Acts for 
        fiscal year 2018.
    ``(h) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a fee assessed under subsection (a) within 
30 days after it is due, such fee shall be treated as a claim of the 
United States Government subject to subchapter II of chapter 37 of 
title 31, United States Code.
    ``(i) Written Requests for Waivers, Reductions, and Refunds.--To 
qualify for consideration for a waiver or reduction under subsection 
(d), or for a refund of any fee collected in accordance with subsection 
(a), a person shall submit to the Secretary a written request for such 
waiver, reduction, or refund not later than 180 days after such fee is 
due.
    ``(j) Construction.--This section may not be construed to require 
that the number of full-time equivalent positions in the Department of 
Health and Human Services, for officers, employees, and advisory 
committees not engaged in the process of the review of abbreviated 
applications for generic new animal drugs, be reduced to offset the 
number of officers, employees, and advisory committees so engaged.
    ``(k) Definitions.--In this section and section 742:
            ``(1) Abbreviated application for a generic new animal 
        drug.--The terms `abbreviated application for a generic new 
        animal drug' and `abbreviated application' mean an abbreviated 
        application for the approval of any generic new animal drug 
        submitted under section 512(b)(2). Such term does not include a 
        supplemental abbreviated application for a generic new animal 
        drug.
            ``(2) Adjustment factor.--The term `adjustment factor' 
        applicable to a fiscal year is the Consumer Price Index for all 
        urban consumers (all items; United States city average) for 
        October of the preceding fiscal year divided by--
                    ``(A) for purposes of subsection (f)(1), such Index 
                for October 2002; and
                    ``(B) for purposes of subsection (g)(2)(A)(ii), 
                such Index for October 2007.
            ``(3) Costs of resources allocated for the process for the 
        review of abbreviated applications for generic new animal 
        drugs.--The term `costs of resources allocated for the process 
        for the review of abbreviated applications for generic new 
        animal drugs' means the expenses in connection with the process 
        for the review of abbreviated applications for generic new 
        animal drugs for--
                    ``(A) officers and employees of the Food and Drug 
                Administration, contractors of the Food and Drug 
                Administration, advisory committees consulted with 
                respect to the review of specific abbreviated 
                applications, supplemental abbreviated applications, or 
                investigational submissions, and costs related to such 
                officers, employees, committees, and contractors, 
                including costs for travel, education, and recruitment 
                and other personnel activities;
                    ``(B) management of information, and the 
                acquisition, maintenance, and repair of computer 
                resources;
                    ``(C) leasing, maintenance, renovation, and repair 
                of facilities and acquisition, maintenance, and repair 
                of fixtures, furniture, scientific equipment, and other 
                necessary materials and supplies; and
                    ``(D) collecting fees under this section and 
                accounting for resources allocated for the review of 
                abbreviated applications, supplemental abbreviated 
                applications, and investigational submissions.
            ``(4) Final dosage form.--The term `final dosage form' 
        means, with respect to a generic new animal drug product, a 
        finished dosage form which is approved for administration to an 
        animal without substantial further manufacturing. Such term 
        includes generic new animal drug products intended for mixing 
        in animal feeds.
            ``(5) Generic new animal drug.--The term `generic new 
        animal drug' means a new animal drug that is the subject of an 
        abbreviated application.
            ``(6) Generic new animal drug product.--The term `generic 
        new animal drug product' means each specific strength or 
        potency of a particular active ingredient or ingredients in 
        final dosage form marketed by a particular manufacturer or 
        distributor, which is uniquely identified by the labeler code 
        and product code portions of the national drug code, and for 
        which an abbreviated application for a generic new animal drug 
        or a supplemental abbreviated application has been approved.
            ``(7) Generic new animal drug sponsor.--The term `generic 
        new animal drug sponsor' means either an applicant named in an 
        abbreviated application for a generic new animal drug that has 
        not been withdrawn by the applicant and for which approval has 
        not been withdrawn by the Secretary, or a person who has 
        submitted an investigational submission for a generic new 
        animal drug that has not been terminated or otherwise rendered 
        inactive by the Secretary.
            ``(8) Investigational submission for a generic new animal 
        drug.--The terms `investigational submission for a generic new 
        animal drug' and `investigational submission' mean--
                    ``(A) the filing of a claim for an investigational 
                exemption under section 512(j) for a generic new animal 
                drug intended to be the subject of an abbreviated 
                application or a supplemental abbreviated application; 
                or
                    ``(B) the submission of information for the purpose 
                of enabling the Secretary to evaluate the safety or 
                effectiveness of a generic new animal drug in the event 
                of the filing of an abbreviated application or 
                supplemental abbreviated application for such drug.
            ``(9) Person.--The term `person' includes an affiliate 
        thereof (as such term is defined in section 735(11)).
            ``(10) Process for the review of abbreviated applications 
        for generic new animal drugs.--The term `process for the review 
        of abbreviated applications for generic new animal drugs' means 
        the following activities of the Secretary with respect to the 
        review of abbreviated applications, supplemental abbreviated 
        applications, and investigational submissions:
                    ``(A) The activities necessary for the review of 
                abbreviated applications, supplemental abbreviated 
                applications, and investigational submissions.
                    ``(B) The issuance of action letters which approve 
                abbreviated applications or supplemental abbreviated 
                applications or which set forth in detail the specific 
                deficiencies in abbreviated applications, supplemental 
                abbreviated applications, or investigational 
                submissions and, where appropriate, the actions 
                necessary to place such applications, supplemental 
                applications, or submissions in condition for approval.
                    ``(C) The inspection of generic new animal drug 
                establishments and other facilities undertaken as part 
                of the Secretary's review of pending abbreviated 
                applications, supplemental abbreviated applications, 
                and investigational submissions.
                    ``(D) Monitoring of research conducted in 
                connection with the review of abbreviated applications, 
                supplemental abbreviated applications, and 
                investigational submissions.
                    ``(E) The development of regulations and policy 
                related to the review of abbreviated applications, 
                supplemental abbreviated applications, and 
                investigational submissions.
                    ``(F) Development of standards for products subject 
                to review.
                    ``(G) Meetings between the agency and the generic 
                new animal drug sponsor.
                    ``(H) Review of advertising and labeling prior to 
                approval of an abbreviated application or supplemental 
                abbreviated application, but not after such application 
                has been approved.
            ``(11) Supplemental abbreviated application for generic new 
        animal drug.--The terms `supplemental abbreviated application 
        for a generic new animal drug' and `supplemental abbreviated 
        application' mean a request to the Secretary to approve a 
        change in an approved abbreviated application.''.

SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS.

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

``SEC. 742. REAUTHORIZATION; REPORTING REQUIREMENTS.

    ``(a) Performance Reports.--Beginning with fiscal year 2014, not 
later than 120 days after the end of each fiscal year during which fees 
are collected under this part, the Secretary shall prepare and submit 
to the Committee on Health, Education, Labor, and Pensions of the 
Senate, and the Committee on Energy and Commerce of the House of 
Representatives a report concerning the progress of the Food and Drug 
Administration in achieving the goals identified in the letters 
described in section 201(b) of the Animal Generic Drug User Fee 
Amendments of 2013 toward expediting the generic new animal drug 
development process and the review of abbreviated applications for 
generic new animal drugs, supplemental abbreviated applications for 
generic new animal drugs, and investigational submissions for generic 
new animal drugs during such fiscal year.
    ``(b) Fiscal Report.--Beginning with fiscal year 2014, not later 
than 120 days after the end of each fiscal year during which fees are 
collected under this part, the Secretary shall prepare and submit to 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives a 
report on the implementation of the authority for such fees during such 
fiscal year and the use, by the Food and Drug Administration, of the 
fees collected during such fiscal year for which the report is made.
    ``(c) Public Availability.--The Secretary shall make the reports 
required under subsections (a) and (b) available to the public on the 
Internet Web site of the Food and Drug Administration.
    ``(d) Reauthorization.--
            ``(1) Consultation.--In developing recommendations to 
        present to Congress with respect to the goals, and plans for 
        meeting the goals, for the process for the review of 
        abbreviated applications for generic new animal drugs for the 
        first 5 fiscal years after fiscal year 2018, and for the 
        reauthorization of this part for such fiscal years, the 
        Secretary shall consult with--
                    ``(A) the Committee on Energy and Commerce of the 
                House of Representatives;
                    ``(B) the Committee on Health, Education, Labor, 
                and Pensions of the Senate;
                    ``(C) scientific and academic experts;
                    ``(D) veterinary professionals;
                    ``(E) representatives of patient and consumer 
                advocacy groups; and
                    ``(F) the regulated industry.
            ``(2) Prior public input.--Prior to beginning negotiations 
        with the regulated industry on the reauthorization of this 
        part, the Secretary shall--
                    ``(A) publish a notice in the Federal Register 
                requesting public input on the reauthorization;
                    ``(B) hold a public meeting at which the public may 
                present its views on the reauthorization, including 
                specific suggestions for changes to the goals referred 
                to in subsection (a);
                    ``(C) provide a period of 30 days after the public 
                meeting to obtain written comments from the public 
                suggesting changes to this part; and
                    ``(D) publish the comments on the Food and Drug 
                Administration's Internet Web site.
            ``(3) Periodic consultation.--Not less frequently than once 
        every 4 months during negotiations with the regulated industry, 
        the Secretary shall hold discussions with representatives of 
        veterinary, patient, and consumer advocacy groups to continue 
        discussions of their views on the reauthorization and their 
        suggestions for changes to this part as expressed under 
        paragraph (2).
            ``(4) Public review of recommendations.--After negotiations 
        with the regulated industry, the Secretary shall--
                    ``(A) present the recommendations developed under 
                paragraph (1) to the congressional committees specified 
                in such paragraph;
                    ``(B) publish such recommendations in the Federal 
                Register;
                    ``(C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                    ``(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                    ``(E) after consideration of such public views and 
                comments, revise such recommendations as necessary.
            ``(5) Transmittal of recommendations.--Not later than 
        January 15, 2018, the Secretary shall transmit to Congress the 
        revised recommendations under paragraph (4), a summary of the 
        views and comments received under such paragraph, and any 
        changes made to the recommendations in response to such views 
        and comments.
            ``(6) Minutes of negotiation meetings.--
                    ``(A) Public availability.--Before presenting the 
                recommendations developed under paragraphs (1) through 
                (5) to Congress, the Secretary shall make publicly 
                available, on the Internet Web site of the Food and 
                Drug Administration, minutes of all negotiation 
                meetings conducted under this subsection between the 
                Food and Drug Administration and the regulated 
                industry.
                    ``(B) Content.--The minutes described under 
                subparagraph (A) shall summarize any substantive 
                proposal made by any party to the negotiations as well 
                as significant controversies or differences of opinion 
                during the negotiations and their resolution.''.

SEC. 204. SAVINGS CLAUSE.

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

SEC. 205. EFFECTIVE DATE.

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

SEC. 206. SUNSET DATES.

    (a) Authorization.--Section 741 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-21) shall cease to be effective October 1, 
2018.
    (b) Reporting Requirements.--Section 742 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-22) shall cease to be effective 
January 31, 2019.
    (c) Previous Sunset Provision.--
            (1) In general.--Section 204 of the Animal Generic Drug 
        User Fee Act of 2008 (Public Law 110-316) is repealed.
            (2) Conforming amendment.--The Animal Generic Drug User Fee 
        Act of 2008 (Public Law 110-316) is amended in the table of 
        contents in section 1, by striking the item relating to section 
        204.
                                                        Calendar No. 31

113th CONGRESS

  1st Session

                                 S. 622

_______________________________________________________________________

                                 A BILL

 To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user 
fee programs relating to new animal drugs and generic new animal drugs.

_______________________________________________________________________

                             March 20, 2013

                 Read twice and placed on the calendar