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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3988 Introduced in House (IH)]

112th CONGRESS
  2d Session
                                H. R. 3988

To amend the Federal Food, Drug, and Cosmetic Act to establish user-fee 
              programs for generic drugs and biosimilars.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                            February 8, 2012

 Mr. Murphy of Pennsylvania (for himself, Mr. Pallone, Mr. Pitts, and 
 Mr. Waxman) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
To amend the Federal Food, Drug, and Cosmetic Act to establish user-fee 
              programs for generic drugs and biosimilars.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    This Act may be cited as the ``Generic Drug and Biosimilar User Fee 
Act of 2012''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. Table of contents.
                TITLE I--FEES RELATING TO GENERIC DRUGS

Sec. 101. Short title; references in title; findings.
Sec. 102. Authority to assess and use human generic drug fees.
Sec. 103. Reauthorization; reporting requirements.
Sec. 104. Sunset dates.
Sec. 105. Effective date.
Sec. 106. Amendment with respect to misbranding.
Sec. 107. Electronic submission of applications.
Sec. 108. Streamlined hiring authority of the Food and Drug 
                            Administration to support activities 
                            related to human generic drugs.
       TITLE II--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

Sec. 201. Short title; references in title; finding.
Sec. 202. Fees relating to biosimilar biological products.
Sec. 203. Reauthorization; reporting requirements.
Sec. 204. Sunset dates.
Sec. 205. Effective date.
Sec. 206. Savings clause.
Sec. 207. Technical amendment; conforming amendment.

                TITLE I--FEES RELATING TO GENERIC DRUGS

SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDINGS.

    (a) Short Title.--This title may be cited as the ``Generic Drug 
User Fee Amendments of 2012''.
    (b) References in Act.--Except as otherwise specified, amendments 
made by this title 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.).
    (c) Findings.--The Congress finds that the fees authorized by the 
amendments made in this title will be dedicated, 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 Health, Education, Labor, 
and Pensions of the Senate and the Chairman of the Committee on Energy 
and Commerce of the House of Representatives, as set forth in the 
Congressional Record. These fees are intended to help the Food and Drug 
Administration ensure that participants in the United States generic 
drug system comply with United States quality standards, and to 
increase the likelihood that American consumers have timely access to 
low-cost, high-quality generic drugs. A comprehensive human generic 
drug user fee program, to be supplemental to traditional appropriated 
funding, should be focused on three key aims:
            (1) Safety.--Ensure that industry participants, foreign or 
        domestic, who participate in the United States generic drug 
        system are held to consistent high-quality standards and are 
        inspected biennially, using a risk-based approach, with foreign 
        and domestic parity.
            (2) Access.--Expedite the availability of low-cost, high-
        quality generic drugs by bringing greater predictability to the 
        review times for abbreviated new drug applications, amendments, 
        and supplements, increasing predictability and timeliness in 
        the review process.
            (3) Transparency.--Enhance the Food and Drug 
        Administration's ability to protect Americans in the complex 
        global supply environment by requiring the identification of 
        facilities involved in the manufacture of generic drugs and 
        associated active pharmaceutical ingredients, and improving the 
        Food and Drug Administration's communications and feedback with 
        industry in order to expedite product access.

SEC. 102. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.

    Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by 
adding at the end the following:

                ``PART 7--FEES RELATING TO GENERIC DRUGS

``SEC. 744A. DEFINITIONS.

    ``For purposes of this part:
            ``(1) The term `abbreviated new drug application'--
                    ``(A) means an application submitted under section 
                505(j), an abbreviated application submitted under 
                section 507 (as in effect on the day before the date of 
                enactment of the Food and Drug Administration 
                Modernization Act of 1997), or an abbreviated new drug 
                application submitted pursuant to regulations in effect 
                prior to the implementation of the Drug Price 
                Competition and Patent Term Restoration Act of 1984; 
                and
                    ``(B) does not include an application for a 
                positron emission tomography drug.
            ``(2) The term `active pharmaceutical ingredient' means--
                    ``(A) a substance, or a mixture when the substance 
                is unstable or cannot be transported on its own, 
                intended--
                            ``(i) to be used as a component of a drug; 
                        and
                            ``(ii) to furnish pharmacological activity 
                        or other direct effect in the diagnosis, cure, 
                        mitigation, treatment, or prevention of 
                        disease, or to affect the structure or any 
                        function of the human body; or
                    ``(B) a substance intended for final 
                crystallization, purification, or salt formation, or 
                any combination of those activities, to become a 
                substance or mixture described in subparagraph (A).
            ``(3) The term `adjustment factor' means a factor 
        applicable to a fiscal year that is the Consumer Price Index 
        for all urban consumers (all items; United States city average) 
        for October of the preceding fiscal year divided by such Index 
        for October 2011.
            ``(4) The term `affiliate' means a business entity that has 
        a relationship with a second business entity if, directly or 
        indirectly--
                    ``(A) one business entity controls, or has the 
                power to control, the other business entity; or
                    ``(B) a third party controls, or has power to 
                control, both of the business entities.
            ``(5)(A) The term `facility'--
                    ``(i) means a business or other entity--
                            ``(I) under one management, either direct 
                        or indirect; and
                            ``(II) at one geographic location or 
                        address engaged in manufacturing or processing 
                        an active pharmaceutical ingredient or a 
                        finished dosage form; and
                    ``(ii) does not include a business or other entity 
                whose only manufacturing or processing activities are 
                one or more of the following: repackaging, relabeling, 
                or testing.
            ``(B) For purposes of subparagraph (A), separate buildings 
        within close proximity are considered to be at one geographic 
        location or address if the activities in them are--
                    ``(i) closely related to the same business 
                enterprise;
                    ``(ii) under the supervision of the same local 
                management; and
                    ``(iii) capable of being inspected by the Food and 
                Drug Administration during a single inspection.
            ``(C) If a business or other entity would meet the 
        definition of a facility under this paragraph but for being 
        under multiple management, the business or other entity is 
        deemed to constitute multiple facilities, one per management 
        entity, for purposes of this paragraph.
            ``(6) The term `finished dosage form' means--
                    ``(A) a drug product in the form in which it will 
                be administered to a patient, such as a tablet, 
                capsule, solution, or topical application;
                    ``(B) a drug product in a form in which 
                reconstitution is necessary prior to administration to 
                a patient, such as oral suspensions or lyophilized 
                powders; or
                    ``(C) any combination of an active pharmaceutical 
                ingredient with another component of a drug product for 
                purposes of production of a drug product described in 
                subparagraph (A) or (B).
            ``(7) The term `generic drug submission' means an 
        abbreviated new drug application, an amendment to an 
        abbreviated new drug application, or a prior approval 
        supplement to an abbreviated new drug application.
            ``(8) The term `human generic drug activities' means the 
        following activities of the Secretary associated with generic 
        drugs and inspection of facilities associated with generic 
        drugs:
                    ``(A) The activities necessary for the review of 
                generic drug submissions, including review of drug 
                master files referenced in such submissions.
                    ``(B) The issuance of--
                            ``(i) approval letters which approve 
                        abbreviated new drug applications or 
                        supplements to such applications; or
                            ``(ii) complete response letters which set 
                        forth in detail the specific deficiencies in 
                        such applications and, where appropriate, the 
                        actions necessary to place such applications in 
                        condition for approval.
                    ``(C) The issuance of letters related to Type II 
                active pharmaceutical drug master files which--
                            ``(i) set forth in detail the specific 
                        deficiencies in such submissions, and where 
                        appropriate, the actions necessary to resolve 
                        those deficiencies; or
                            ``(ii) document that no deficiencies need 
                        to be addressed.
                    ``(D) Inspections related to generic drugs.
                    ``(E) Monitoring of research conducted in 
                connection with the review of generic drug submissions 
                and drug master files.
                    ``(F) Postmarket safety activities with respect to 
                drugs approved under abbreviated new drug applications 
                or supplements, including the following activities:
                            ``(i) Collecting, developing, and reviewing 
                        safety information on approved drugs, including 
                        adverse event reports.
                            ``(ii) Developing and using improved 
                        adverse-event data-collection systems, 
                        including information technology systems.
                            ``(iii) Developing and using improved 
                        analytical tools to assess potential safety 
                        problems, including access to external data 
                        bases.
                            ``(iv) Implementing and enforcing section 
                        505(o) (relating to postapproval studies and 
                        clinical trials and labeling changes) and 
                        section 505(p) (relating to risk evaluation and 
                        mitigation strategies) insofar as those 
                        activities relate to abbreviated new drug 
                        applications.
                            ``(v) Carrying out section 505(k)(5) 
                        (relating to adverse event reports and 
                        postmarket safety activities).
                    ``(G) Regulatory science activities related to 
                generic drugs.
            ``(9) The term `positron emission tomography drug' has the 
        meaning given to the term `compounded positron emission 
        tomography drug' in section 201(ii), except that paragraph 
        (1)(B) of such section shall not apply.
            ``(10) The term `prior approval supplement' means a request 
        to the Secretary to approve a change in the drug substance, 
        drug product, production process, quality controls, equipment, 
        or facilities covered by an approved abbreviated new drug 
        application when that change has a substantial potential to 
        have an adverse effect on the identity, strength, quality, 
        purity, or potency of the drug product as these factors may 
        relate to the safety or effectiveness of the drug product.
            ``(11) The term `resources allocated for human generic drug 
        activities' means the expenses for--
                    ``(A) officers and employees of the Food and Drug 
                Administration, contractors of the Food and Drug 
                Administration, advisory committees, and costs related 
                to such officers and employees and to contracts with 
                such contractors;
                    ``(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 subsection (a) and 
                accounting for resources allocated for the review of 
                abbreviated new drug applications and supplements and 
                inspection related to generic drugs.
            ``(12) The term `Type II active pharmaceutical ingredient 
        drug master file' means a submission of information to the 
        Secretary by a person that intends to authorize the Food and 
        Drug Administration to reference the information to support 
        approval of a generic drug submission without the submitter 
        having to disclose the information to the generic drug 
        submission applicant.

``SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.

    ``(a) Types of Fees.--Beginning in fiscal year 2013, the Secretary 
shall assess and collect fees in accordance with this section as 
follows:
            ``(1) One-time backlog fee for abbreviated new drug 
        applications pending on october 1, 2012.--
                    ``(A) In general.--Each person that owns an 
                abbreviated new drug application that is pending on 
                October 1, 2012, and that has not received a tentative 
                approval prior to that date, shall be subject to a fee 
                for each such application, as calculated under 
                subparagraph (B).
                    ``(B) Method of fee amount calculation.--The amount 
                of each one-time backlog fee shall be calculated by 
                dividing $50,000,000 by the total number of abbreviated 
                new drug applications pending on October 1, 2012, that 
                have not received a tentative approval as of that date.
                    ``(C) Notice.--Not later than October 31, 2012, the 
                Secretary shall cause to be published in the Federal 
                Register a notice announcing the amount of the fee 
                required by subparagraph (A).
                    ``(D) Fee due date.--The fee required by 
                subparagraph (A) shall be due no later than 30 calendar 
                days after the date of the publication of the notice 
                specified in subparagraph (C).
            ``(2) Drug master file fee.--
                    ``(A) In general.--Each person that owns a Type II 
                active pharmaceutical ingredient drug master file that 
                is referenced on or after October 1, 2012, in a generic 
                drug submission by any initial letter of authorization 
                shall be subject to a drug master file fee.
                    ``(B) One-time payment.--If a person has paid a 
                drug master file fee for a Type II active 
                pharmaceutical ingredient drug master file, the person 
                shall not be required to pay a subsequent drug master 
                file fee when that Type II active pharmaceutical 
                ingredient drug master file is subsequently referenced 
                in generic drug submissions.
                    ``(C) Notice.--
                            ``(i) Fiscal year 2013.--Not later than 
                        October 31, 2012, the Secretary shall cause to 
                        be published in the Federal Register a notice 
                        announcing the amount of the drug master file 
                        fee for fiscal year 2013.
                            ``(ii) Fiscal year 2014 through 2017.--Not 
                        later than 60 days before the start of each of 
                        fiscal years 2014 through 2017, the Secretary 
                        shall cause to be published in the Federal 
                        Register the amount of the drug master file fee 
                        established by this paragraph for such fiscal 
                        year.
                    ``(D) Availability for reference.--
                            ``(i) In general.--Subject to subsection 
                        (g)(2)(C), for a generic drug submission to 
                        reference a Type II active pharmaceutical 
                        ingredient drug master file, the drug master 
                        file must be deemed available for reference by 
                        the Secretary.
                            ``(ii) Conditions.--A drug master file 
                        shall be deemed available for reference by the 
                        Secretary if--
                                    ``(I) the person that owns a Type 
                                II active pharmaceutical ingredient 
                                drug master file has paid the fee 
                                required under subparagraph (A) within 
                                20 calendar days after the applicable 
                                due date under subparagraph (E); and
                                    ``(II) the drug master file has not 
                                failed an initial completeness 
                                assessment by the Secretary, in 
                                accordance with criteria to be 
                                published by the Secretary.
                            ``(iii) List.--The Secretary shall make 
                        available on the public Internet Web site of 
                        the Food and Drug Administration a list of the 
                        drug master file numbers that correspond to 
                        drug master files that have successfully 
                        undergone an initial completeness assessment, 
                        in accordance with criteria to be published by 
                        the Secretary, and are available for reference.
                    ``(E) Fee due date.--
                            ``(i) In general.--Subject to clauses (ii), 
                        a drug master file fee shall be due no later 
                        than the date on which the first generic drug 
                        submission is submitted that references the 
                        associated Type II active pharmaceutical 
                        ingredient drug master file.
                            ``(ii) Limitation.--No fee shall be due 
                        under subparagraph (A) for a fiscal year until 
                        the later of--
                                    ``(I) 30 calendar days after 
                                publication of the notice provided for 
                                in clause (i) or (ii) of subparagraph 
                                (C), as applicable; or
                                    ``(II) 30 calendar days after the 
                                date of enactment of an appropriations 
                                Act providing for the collection and 
                                obligation of fees under this section
            ``(3) Abbreviated new drug application and prior approval 
        supplement filing fee.--
                    ``(A) In general.--Each applicant that submits, on 
                or after October 1, 2012, an abbreviated new drug 
                application or a prior approval supplement to an 
                abbreviated new drug application shall be subject to a 
                fee for each such submission in the amount established 
                under subsection (d).
                    ``(B) Notice.--
                            ``(i) Fiscal year 2013.--Not later than 
                        October 31, 2012, the Secretary shall cause to 
                        be published in the Federal Register a notice 
                        announcing the amount of the fees under 
                        subparagraph (A) for fiscal year 2013.
                            ``(ii) Fiscal years 2014 through 2017.--Not 
                        later than 60 days before the start of each of 
                        fiscal years 2014 through 2017, the Secretary 
                        shall cause to be published in the Federal 
                        Register the amount of the fees under 
                        subparagraph (A) for such fiscal year.
                    ``(C) Fee due date.--
                            ``(i) In general.--Except as provided in 
                        clause (ii), the fees required by subparagraphs 
                        (A) and (F) shall be due no later than the date 
                        of submission of the abbreviated new drug 
                        application or prior approval supplement for 
                        which such fee applies.
                            ``(ii) Special rule for 2013.--For fiscal 
                        year 2013, such fees shall be due on the later 
                        of--
                                    ``(I) the date on which the fee is 
                                due under clause (i);
                                    ``(II) 30 calendar days after 
                                publication of the notice referred to 
                                in subparagraph (B)(i); or
                                    ``(III) if an appropriations Act is 
                                not enacted providing for the 
                                collection and obligation of fees under 
                                this section by the date of submission 
                                of the application or prior approval 
                                supplement for which the fees under 
                                subparagraphs (A) and (F) apply, 30 
                                calendar days after the date that such 
                                an appropriations Act is enacted.
                    ``(D) Refund of fee if abbreviated new drug 
                application is not considered to have been received.--
                The Secretary shall refund 75 percent of the fee paid 
                under subparagraph (A) for any abbreviated new drug 
                application or prior approval supplement to an 
                abbreviated new drug application that the Secretary 
                considers not to have been received within the meaning 
                of section 505(j)(5)(A) for a cause other than failure 
                to pay fees.
                    ``(E) Fee for an application the secretary 
                considers not to have been received, or that has been 
                withdrawn.--An abbreviated new drug application or 
                prior approval supplement that was submitted on or 
                after October 1, 2012, and that the Secretary considers 
                not to have been received, or that has been withdrawn, 
                shall, upon resubmission of the application or a 
                subsequent new submission following the applicant's 
                withdrawal of the application, be subject to a full fee 
                under subparagraph (A).
                    ``(F) Additional fee for active pharmaceutical 
                ingredient information not included by reference to 
                type ii active pharmaceutical ingredient drug master 
                file.--An applicant that submits a generic drug 
                submission on or after October 1, 2012, shall pay a 
                fee, in the amount determined under subsection (d)(3), 
                in addition to the fee required under subparagraph (A), 
                if--
                            ``(i) such submission contains information 
                        concerning the manufacture of an active 
                        pharmaceutical ingredient at a facility by 
                        means other than reference by a letter of 
                        authorization to a Type II active 
                        pharmaceutical drug master file; and
                            ``(ii) a fee in the amount equal to the 
                        drug master file fee established in paragraph 
                        (2) has not been previously paid with respect 
                        to such information.
            ``(4) Generic drug facility fee and active pharmaceutical 
        ingredient facility fee.--
                    ``(A) In general.--Facilities identified, or 
                intended to be identified, in at least one generic drug 
                submission that is pending or approved to produce a 
                finished dosage form of a human generic drug or an 
                active pharmaceutical ingredient contained in a human 
                generic drug shall be subject to fees as follows:
                            ``(i) Generic drug facility.--Each person 
                        that owns a facility which is identified or 
                        intended to be identified in at least one 
                        generic drug submission that is pending or 
                        approved to produce one or more finished dosage 
                        forms of a human generic drug shall be assessed 
                        an annual fee for each such facility.
                            ``(ii) Active pharmaceutical ingredient 
                        facility.--Each person that owns a facility 
                        which produces, or which is pending review to 
                        produce, one or more active pharmaceutical 
                        ingredients identified, or intended to be 
                        identified, in at least one generic drug 
                        submission that is pending or approved or in a 
                        Type II active pharmaceutical ingredient drug 
                        master file referenced in such a generic drug 
                        submission, shall be assessed an annual fee for 
                        each such facility.
                            ``(iii) Facilities producing both active 
                        pharmaceutical ingredients and finished dosage 
                        forms.--Each person that owns a facility 
                        identified, or intended to be identified, in at 
                        least one generic drug submission that is 
                        pending or approved to produce both one or more 
                        finished dosage forms subject to clause (i) and 
                        one or more active pharmaceutical ingredients 
                        subject to clause (ii) shall be subject to fees 
                        under both such clauses for that facility.
                    ``(B) Amount.--The amount of fees established under 
                subparagraph (A) shall be established under subsection 
                (d).
                    ``(C) Notice.--
                            ``(i) Fiscal year 2013.--For fiscal year 
                        2013, the Secretary shall cause to be published 
                        in the Federal Register a notice announcing the 
                        amount of the fees provided for in subparagraph 
                        (A) within the timeframe specified in 
                        subsection (d)(1)(B).
                            ``(ii) Fiscal years 2014 through 2017.--
                        Within the timeframe specified in subsection 
                        (d)(2), the Secretary shall cause to be 
                        published in the Federal Register the amount of 
                        the fees under subparagraph (A) for such fiscal 
                        year.
                    ``(D) Fee due date.--
                            ``(i) Fiscal year 2013.--For fiscal year 
                        2013, the fees under subparagraph (A) shall be 
                        due on the later of--
                                    ``(I) not later than 45 days after 
                                the publication of the notice under 
                                subparagraph (B); or
                                    ``(II) if an appropriations Act is 
                                not enacted providing for the 
                                collection and obligation of fees under 
                                this section by the date of the 
                                publication of such notice, 30 days 
                                after the date that such an 
                                appropriations Act is enacted.
                            ``(ii) Fiscal years 2014 through 2017.--For 
                        each of fiscal years 2014 through 2017, the 
                        fees under subparagraph (A) for such fiscal 
                        year shall be due on the later of--
                                    ``(I) the first business day on or 
                                after October 1 of each such year; or
                                    ``(II) the first business day after 
                                the enactment of an appropriations Act 
                                providing for the collection and 
                                obligation of fees under this section 
                                for such year.
            ``(5) Date of submission.--For purposes of this part, a 
        generic drug submission or Type II pharmaceutical master file 
        is deemed to be `submitted' to the Food and Drug Administration 
        when it arrives in the appropriate electronic portal of the 
        Food and Drug Administration or, if in paper form, at the 
        appropriate designated document room of the Food and Drug 
        Administration.
    ``(b) Fee Revenue Amounts.--
            ``(1) In general.--
                    ``(A) Fiscal year 2013.--For fiscal year 2013, fees 
                under subsection (a) shall be established to generate a 
                total estimated revenue amount under such subsection of 
                $299,000,000. Of that amount--
                            ``(i) $50,000,000 shall be generated by the 
                        one-time backlog fee for generic drug 
                        applications pending on October 1, 2012, 
                        established in subsection (a)(1); and
                            ``(ii) $249,000,000 shall be generated by 
                        the fees under paragraphs (2) through (4) of 
                        subsection (a).
                    ``(B) Fiscal years 2014 through 2017.--For each of 
                the fiscal years 2014 through 2017, fees under 
                paragraphs (2) through (4) of subsection (a) shall be 
                established to generate a total estimated revenue 
                amount under such subsection that is equal to 
                $299,000,000, as adjusted pursuant to subsection (c).
            ``(2) Types of fees.--In establishing fees under paragraph 
        (1) to generate the revenue amounts specified in paragraph 
        (1)(A)(ii) for fiscal year 2013 and (1)(B) for each of fiscal 
        years 2014 through 2017, such fees shall be derived from the 
        fees under paragraphs (2) through (4) of subsection (a) as 
        follows:
                    ``(A) 6 percent shall be derived from fees under 
                subsection (a)(2) (relating to drug master files).
                    ``(B) 24 percent shall be derived from fees under 
                subsection (a)(3) (relating to abbreviated new drug 
                applications and supplements). The amount of a fee for 
                a prior approval supplement shall be half the amount of 
                the fee for an abbreviated new drug application.
                    ``(C) 56 percent shall be derived from fees under 
                subsection (a)(4)(A)(i) (relating to generic drug 
                facilities). The amount of the fee for a facility 
                located outside the United States and its territories 
                and possessions shall be not less than $15,000 and not 
                more than $30,000 higher than the amount of the fee for 
                a facility located in the United States and its 
                territories and possessions, as determined by the 
                Secretary on the basis of data concerning the 
                difference in cost between inspections of facilities 
                located in the United States, including its territories 
                and possessions, and those located outside of the 
                United States and its territories and possessions.
                    ``(D) 14 percent shall be derived from fees under 
                subsection (a)(4)(A)(ii) (relating to active 
                pharmaceutical ingredient facilities). The amount of 
                the fee for a facility located outside the United 
                States and its territories and possessions shall be not 
                less than $15,000 and not more than $30,000 higher than 
                the amount of the fee for a facility located in the 
                United States, including its territories and 
                possessions, as determined by the Secretary on the 
                basis of data concerning the difference in cost between 
                inspections of facilities located in the United States 
                and its territories and possessions and those located 
                outside of the United States and its territories and 
                possessions.
    ``(c) Adjustments.--
            ``(1) Inflation adjustment.--For fiscal year 2014 and 
        subsequent fiscal years, the revenues 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 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 years of the preceding 4 fiscal years 
                multiplied by the proportion of personnel compensation 
                and benefits costs to total costs of human generic drug 
                activities for the first 3 years of the preceding 4 
                fiscal years; and
                    ``(C) the average annual change that occurred in 
                the Consumer Price Index for urban consumers 
                (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally 
                Adjusted; All items; Annual Index) for the first 3 
                years of the preceding 4 years of available data 
                multiplied by the proportion of all costs other than 
                personnel compensation and benefits costs to total 
                costs of human generic drug activities for the first 3 
                years of the preceding 4 fiscal years.
        The adjustment made each fiscal year under this subsection 
        shall be added on a compounded basis to the sum of all 
        adjustments made each fiscal year after fiscal year 2013 under 
        this subsection.
            ``(2) Final year adjustment.--For fiscal year 2017, the 
        Secretary may, in addition to adjustments under paragraph (1), 
        further increase the fee revenues and fees established in 
        subsection (b) if such an adjustment is necessary to provide 
        for not more than 3 months of operating reserves of carryover 
        user fees for human generic drug activities for the first 3 
        months of fiscal year 2018. Such fees may only be used in 
        fiscal year 2018. If such an adjustment is necessary, the 
        rationale for the amount of the increase shall be contained in 
        the annual notice establishing fee revenues and fees for fiscal 
        year 2017. If the Secretary has carryover balances for such 
        activities in excess of 3 months of such operating reserves, 
        the adjustment under this subparagraph shall not be made.
    ``(d) Annual Fee Setting.--
            ``(1) Fiscal year 2013.--For fiscal year 2013--
                    ``(A) the Secretary shall establish, by October 31, 
                2012, the one-time generic drug backlog fee for generic 
                drug applications pending on October 1, 2012, the drug 
                master file fee, the abbreviated new drug application 
                fee, and the prior approval supplement fee under 
                subsection (a), based on the revenue amounts 
                established under subsection (b); and
                    ``(B) the Secretary shall establish, not later than 
                45 days after the date to comply with the requirement 
                for identification of facilities in subsection (f)(2), 
                the generic drug facility fee and active pharmaceutical 
                ingredient facility fee under subsection (a) based on 
                the revenue amounts established under subsection (b).
            ``(2) Fiscal years 2014 through 2017.--Not more than 60 
        days before the first day of each of fiscal years 2014 through 
        2017, the Secretary shall establish the drug master file fee, 
        the abbreviated new drug application fee, the prior approval 
        supplement fee, the generic drug facility fee, and the active 
        pharmaceutical ingredient facility fee under subsection (a) for 
        such fiscal year, based on the revenue amounts established 
        under subsection (b) and the adjustments provided under 
        subsection (c).
            ``(3) Fee for active pharmaceutical ingredient information 
        not included by reference to type ii active pharmaceutical 
        ingredient drug master file.--In establishing the fees under 
        paragraphs (1) and (2), the amount of the fee under subsection 
        (a)(3)(F) shall be determined by multiplying--
                    ``(A) the sum of--
                            ``(i) the total number of such active 
                        pharmaceutical ingredients in such submission; 
                        and
                            ``(ii) for each such ingredient that is 
                        manufactured at more than one such facility, 
                        the total number of such additional facilities; 
                        and
                    ``(B) the amount equal to the drug master file fee 
                established in subsection (a)(2) for such submission.
    ``(e) Limit.--The total amount of fees charged, as adjusted under 
subsection (c), for a fiscal year may not exceed the total costs for 
such fiscal year for the resources allocated for human generic drug 
activities.
    ``(f) Identification of Facilities.--
            ``(1) Publication of notice; deadline for compliance.--Not 
        later than October 1, 2012, the Secretary shall cause to be 
        published in the Federal Register a notice requiring each 
        person that owns a facility described in subsection (a)(4)(A), 
        or a site or organization required to be identified by 
        paragraph (4), to submit to the Secretary information on the 
        identity of each such facility, site, or organization. The 
        notice required by this paragraph shall specify the type of 
        information to be submitted and the means and format for 
        submission of such information.
            ``(2) Required submission of facility identification.--Each 
        person that owns a facility described in subsection (a)(4)(A) 
        or a site or organization required to be identified by 
        paragraph (4) shall submit to the Secretary the information 
        required under this subsection each year. Such information 
        shall--
                    ``(A) for fiscal year 2013, be submitted not later 
                than 60 days after the publication of the notice under 
                paragraph (1); and
                    ``(B) for each subsequent fiscal year, be 
                submitted, updated, or reconfirmed on or before June 1 
                of such year.
            ``(3) Contents of notice.--At a minimum, the submission 
        required by paragraph (2) shall include for each such 
        facility--
                    ``(A) identification of a facility identified or 
                intended to be identified in an approved or pending 
                generic drug submission;
                    ``(B) whether the facility manufactures active 
                pharmaceutical ingredients or finished dosage forms, or 
                both;
                    ``(C) whether or not the facility is located within 
                the United States and its territories and possessions;
                    ``(D) whether the facility manufactures positron 
                emission tomography drugs solely, or in addition to 
                other drugs; and
                    ``(E) whether the facility manufactures drugs that 
                are not generic drugs.
            ``(4) Certain sites and organizations.--
                    ``(A) In general.--Any person that owns or operates 
                a site or organization described in subparagraph (B) 
                shall submit to the Secretary information concerning 
                the ownership, name, and address of the site or 
                organization.
                    ``(B) Sites and organizations.--A site or 
                organization is described in this subparagraph if it is 
                identified in a generic drug submission and is--
                            ``(i) a site in which a bioanalytical study 
                        is conducted;
                            ``(ii) a clinical research organization;
                            ``(iii) a contract analytical testing site; 
                        or
                            ``(iv) a contract repackager site.
                    ``(C) Notice.--The Secretary may, by notice 
                published in the Federal Register, specify the means 
                and format for submission of the information under 
                subparagraph (A) and may specify, as necessary for 
                purposes of this section, any additional information to 
                be submitted.
                    ``(D) Inspection authority.--The Secretary's 
                inspectional authority under section 704(a)(1) shall 
                extend to all such sites and organizations.
    ``(g) Effect of Failure To Pay Fees.--
            ``(1) Generic drug backlog fee.--Failure to pay the fee 
        under subsection (a)(1) shall result in the Secretary placing 
        the person that owns the abbreviated new drug application 
        subject to that fee on an arrears list, such that no new 
        abbreviated new drug applications or supplement submitted on or 
        after October 1, 2012, from that person, or any affiliate of 
        that person, will be received within the meaning of section 
        505(j)(5)(A) until such outstanding fee is paid.
            ``(2) Drug master file fee.--
                    ``(A) Failure to pay the fee under subsection 
                (a)(2) within 20 calendar days after the applicable due 
                date under subparagraph (E) of such subsection (as 
                described in subsection (a)(2)(D)(ii)(I)) shall result 
                in the Type II active pharmaceutical ingredient drug 
                master file not being deemed available for reference.
                    ``(B)(i) Any generic drug submission submitted on 
                or after October 1, 2012, that references, by a letter 
                of authorization, a Type II active pharmaceutical 
                ingredient drug master file that has not been deemed 
                available for reference shall not be received within 
                the meaning of section 505(j)(5)(A) unless the 
                condition specified in clause (ii) is met.
                    ``(ii) The condition specified in this clause is 
                that the fee established under subsection (a)(2) has 
                been paid within 20 calendar days of the Secretary 
                providing the notification to the sponsor of the 
                abbreviated new drug application or supplement of the 
                failure of the owner of the Type II active 
                pharmaceutical ingredient drug master file to pay the 
                drug master file fee as specified in subparagraph (C).
                    ``(C)(i) If an abbreviated new drug application or 
                supplement to an abbreviated new drug application 
                references a Type II active pharmaceutical ingredient 
                drug master file for which a fee under subsection 
                (a)(2)(A) has not been paid by the applicable date 
                under subsection (a)(2)(E), the Secretary shall notify 
                the sponsor of the abbreviated new drug application or 
                supplement of the failure of the owner of the Type II 
                active pharmaceutical ingredient drug master file to 
                pay the applicable fee.
                    ``(ii) If such fee is not paid within 20 calendar 
                days of the Secretary providing the notification, the 
                abbreviated new drug application or supplement to an 
                abbreviated new drug application shall not be received 
                within the meaning of 505(j)(5)(A).
            ``(3) Abbreviated new drug application fee and prior 
        approval supplement fee.--Failure to pay a fee under 
        subparagraph (A) or (F) of subsection (a)(3) within 20 calendar 
        days of the applicable due date under subparagraph (C) of such 
        subsection shall result in the abbreviated new drug application 
        or the prior approval supplement to an abbreviated new drug 
        application not being received within the meaning of section 
        505(j)(5)(A) until such outstanding fee is paid.
            ``(4) Generic drug facility fee and active pharmaceutical 
        ingredient facility fee.--
                    ``(A) In general.--Failure to pay the fee under 
                subsection (a)(4) within 20 calendar days of the due 
                date as specified in subparagraph (D) of such 
                subsection shall result in the following:
                            ``(i) The Secretary shall place the 
                        facility on a publicly available arrears list, 
                        such that no new abbreviated new drug 
                        application or supplement submitted on or after 
                        October 1, 2012, from the person that is 
                        responsible for paying such fee, or any 
                        affiliate of that person, will be received 
                        within the meaning of section 505(j)(5)(A).
                            ``(ii) Any new generic drug submission 
                        submitted on or after October 1, 2012, that 
                        references such a facility shall not be 
                        received, within the meaning of 505(j)(5)(A) if 
                        the outstanding facility fee is not paid within 
                        20 calendar days of the Secretary providing the 
                        notification to the sponsor of the failure of 
                        the owner of the facility to pay the facility 
                        fee under subsection (a)(4)(C).
                            ``(iii) All drugs or active pharmaceutical 
                        ingredients manufactured in such a facility or 
                        containing an ingredient manufactured in such a 
                        facility shall be deemed misbranded under 
                        section 502(aa).
                    ``(B) Application of penalties.--The penalties 
                under this paragraph shall apply until the fee 
                established by subsection (a)(4) is paid or the 
                facility is removed from all generic drug submissions 
                that refer to the facility.
                    ``(C) Nonreceival for nonpayment.--
                            ``(i) Notice.--If an abbreviated new drug 
                        application or supplement to an abbreviated new 
                        drug application submitted on or after October 
                        1, 2012, references a facility for which a 
                        facility fee has not been paid by the 
                        applicable date under subsection (a)(4)(C), the 
                        Secretary shall notify the sponsor of the 
                        generic drug submission of the failure of the 
                        owner of the facility to pay the facility fee.
                            ``(ii) Nonreceival.--If the facility fee is 
                        not paid within 20 calendar days of the 
                        Secretary providing the notification under 
                        clause (i), the abbreviated new drug 
                        application or supplement to an abbreviated new 
                        drug application shall not be received within 
                        the meaning of 505(j)(5)(A).
    ``(h) Limitations.--
            ``(1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 2012, 
        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 2009 (excluding the amount of fees appropriated for such 
        fiscal year) multiplied by the adjustment factor (as defined in 
        section 744A) 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 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 Type II active 
        pharmaceutical ingredient drug master files, abbreviated new 
        drug applications and prior approval supplements, and generic 
        drug facilities and active pharmaceutical ingredient facilities 
        at any time in such fiscal year notwithstanding the provisions 
        of subsection (a) relating to the date fees are to be paid.
    ``(i) Crediting and Availability of Fees.--
            ``(1) In general.--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, subject to paragraph (2). Such fees are authorized 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 salaries and 
        expenses with such fiscal year limitation. The sums transferred 
        shall be available solely for human generic drug activities.
            ``(2) Collections and appropriation acts.--
                    ``(A) In general.--The fees authorized by this 
                section--
                            ``(i) subject to subparagraphs (C) and (D), 
                        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 for a fiscal year 
                        beginning after fiscal year 2012 to defray the 
                        costs of human generic drug activities 
                        (including such costs for an additional number 
                        of full-time equivalent positions in the 
                        Department of Health and Human Services to be 
                        engaged in such activities), only if the 
                        Secretary allocates for such purpose an amount 
                        for such fiscal year (excluding amounts from 
                        fees collected under this section) no less than 
                        $97,000,000 multiplied by the adjustment factor 
                        defined in subsection (p)(3) applicable to the 
                        fiscal year involved.
                    ``(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 human generic 
                activities are not more than 10 percent below the level 
                specified in such subparagraph.
                    ``(C) Fee collection during first program year.--
                Until the date of enactment of an Act making 
                appropriations through September 30, 2013 for the 
                salaries and expenses account of the Food and Drug 
                Administration, fees authorized by this section for 
                fiscal year 2013, may be collected and shall be 
                credited to such account and remain available until 
                expended.
                    ``(D) Provision for early payments in subsequent 
                years.--Payment of fees authorized under this section 
                for a fiscal year (after fiscal year 2013), 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 2013 through 2017, there is authorized to be 
        appropriated for fees under this section an amount equivalent 
        to the total revenue amount determined under subsection (b) for 
        the fiscal year, as adjusted under subsection (c), if 
        applicable, or as otherwise affected under paragraph (2) of 
        this subsection.
    ``(j) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a fee assessed under subsection (a) within 
30 calendar 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.
    ``(k) 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 human generic drug activities, be reduced to 
offset the number of officers, employees, and advisory committees so 
engaged.
    ``(l) Positron Emission Tomography Drugs.--
            ``(1) Exemption from fees.--Submission of an application 
        for a positron emission tomography drug or active 
        pharmaceutical ingredient for a positron emission tomography 
        drug shall not require the payment of any fee under this 
        section. Facilities that solely produce positron emission 
        tomography drugs shall not be required to pay a facility fee as 
        established in subsection (a)(4).
            ``(2) Identification requirement.--Facilities that produce 
        positron emission tomography drugs or active pharmaceutical 
        ingredients of such drugs are required to be identified 
        pursuant to subsection (f).
    ``(m) Disputes Concerning Fees.--To qualify for the return of a fee 
claimed to have been paid in error under this section, a person shall 
submit to the Secretary a written request justifying such return within 
180 calendar days after such fee was paid.
    ``(n) Substantially Complete Applications.--An abbreviated new drug 
application that is not considered to be received within the meaning of 
section 505(j)(5)(A) because of failure to pay an applicable fee under 
this provision within the time period specified in subsection (g) shall 
be deemed not to have been `substantially complete' on the date of its 
submission within the meaning of section 505(j)(5)(B)(iv)(II)(cc). An 
abbreviated new drug application that is not substantially complete on 
the date of its submission solely because of failure to pay an 
applicable fee under the preceding sentence shall be deemed 
substantially complete and received within the meaning of section 
505(j)(5)(A) as of the date such applicable fee is received.''.

SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS.

    Part 7 of subchapter C of chapter VII, as added by section 102 of 
this Act, is amended by inserting after section 744B the following:

``SEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS.

    ``(a) Performance Report.--Beginning with fiscal year 2013, not 
later than 120 days after the end of each fiscal year for which fees 
are collected under this part, the Secretary shall prepare and submit 
to the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate a report concerning the progress of the Food and Drug 
Administration in achieving the goals identified in the letters 
described in section 101(c) of the Generic Drug User Fee Amendments of 
2012 during such fiscal year and the future plans of the Food and Drug 
Administration for meeting the goals.
    ``(b) Fiscal Report.--Beginning with fiscal year 2013, not later 
than 120 days after the end of each fiscal year for which fees are 
collected under this part, the Secretary shall prepare and submit to 
the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate 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 for such fiscal year.
    ``(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 human generic drug activities for 
        the first 5 fiscal years after fiscal year 2017, 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) health care professionals;
                    ``(E) representatives of patient and consumer 
                advocacy groups; and
                    ``(F) the generic drug industry.
            ``(2) Prior public input.--Prior to beginning negotiations 
        with the generic drug 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 month during negotiations with the generic drug industry, 
        the Secretary shall hold discussions with representatives of 
        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 generic drug 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, 2017, the Secretary shall transmit to the 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 the Congress, the Secretary shall make publicly 
                available, on the public 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 generic drug 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. 104. SUNSET DATES.

    (a) Authorization.--The amendments made by section 102 cease to be 
effective October 1, 2017.
    (b) Reporting Requirements.--The amendments made by section 103 
cease to be effective January 31, 2018.

SEC. 105. EFFECTIVE DATE.

    The amendments made by this title shall take effect on October 1, 
2012, or the date of the enactment of this title, whichever is later, 
except that fees under section 102 shall be assessed for all human 
generic drug submissions and Type II active pharmaceutical drug master 
files received on or after October 1, 2012, regardless of the date of 
enactment of this title.

SEC. 106. AMENDMENT WITH RESPECT TO MISBRANDING.

    Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
352) is amended by adding at the end the following:
    ``(aa) If it is a drug, or an active pharmaceutical ingredient, and 
it was manufactured, prepared, propagated, compounded, or processed in 
a facility for which fees have not been paid as required by section 
744A(a)(4) or for which identifying information required by section 
744B(f) has not been submitted, or it contains an active pharmaceutical 
ingredient that was manufactured, prepared, propagated, compounded, or 
processed in such a facility.''.

SEC. 107. ELECTRONIC SUBMISSION OF APPLICATIONS.

    The Federal Food, Drug, and Cosmetic Act is amended by inserting 
after section 745 the following:

``SEC. 745A. ELECTRONIC SUBMISSION OF APPLICATIONS:.

    ``(a) In General.--Beginning no earlier than 24 months after the 
issuance of a final guidance issued after public notice and opportunity 
for comment, submissions under section 505(j) shall be submitted in 
such electronic format as specified by the Secretary in such guidance.
    ``(b) Guidance Contents.--In such guidance, the Secretary may 
provide a timetable for establishment by the Secretary of further 
standards for such electronic submission, and set forth criteria for 
waivers of and exemptions from the requirements of this section.
    ``(c) Exception.--This section shall not apply to submissions 
described in section 561.''.

SEC. 108. STREAMLINED HIRING AUTHORITY OF THE FOOD AND DRUG 
              ADMINISTRATION TO SUPPORT ACTIVITIES RELATED TO HUMAN 
              GENERIC DRUGS.

    Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 371 et seq.) is amended by inserting after section 713 
the following new section:

``SEC. 714. STREAMLINED HIRING AUTHORITY.

    ``(a) In General.--In addition to any other personnel authorities 
under other provisions of law, the Secretary may, without regard to the 
provisions of title 5, United States Code, governing appointments in 
the competitive service, appoint employees to positions in the Food and 
Drug Administration to perform, administer, or support activities 
described in subsection (b), if the Secretary determines that such 
appointments are needed to achieve the objectives specified in 
subsection (c).
    ``(b) Activities Described.--The activities described in this 
subsection are activities under this Act related to human generic drug 
activities (as defined in section 744A).
    ``(c) Objectives Specified.--The objectives specified in this 
subsection are the performance goals with respect to section 744A 
(regarding assessment and use of human generic drug fees), as set forth 
in the letters described in section 101(c) of the Generic Drug User Fee 
Amendments of 2012.
    ``(d) Internal Controls.--The Secretary shall institute appropriate 
internal controls for appointments under this section.
    ``(e) Sunset.--The authority to appoint employees under this 
section shall terminate on the date that is three years after the date 
of enactment of this section.''.

       TITLE II--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING.

    (a) Short Title.--This title may be cited as the ``Biosimilar User 
Fee Act of 2012''.
    (b) References in Act.--Except as otherwise specified, amendments 
made by this title 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.).
    (c) Finding.--The Congress finds that the fees authorized by the 
amendments made in this title will be dedicated to expediting the 
process for the review of biosimilar biological product applications, 
including postmarket safety activities, as set forth in the goals 
identified for purposes of part 8 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 
Health, Education, Labor, and Pensions of the Senate and the Chairman 
of the Committee on Energy and Commerce of the House of 
Representatives, as set forth in the Congressional Record.

SEC. 202. FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS.

    Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by 
inserting after part 7, as added by title I of this Act, the following:

       ``PART 8--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

``SEC. 744G. DEFINITIONS.

    ``For purposes of this part:
            ``(1) The term `adjustment factor' applicable to a fiscal 
        year that is the Consumer Price Index for all urban consumers 
        (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; 
        All items) of the preceding fiscal year divided by such Index 
        for September 2011.
            ``(2) The term `affiliate' means a business entity that has 
        a relationship with a second business entity if, directly or 
        indirectly--
                    ``(A) one business entity controls, or has the 
                power to control, the other business entity; or
                    ``(B) a third party controls, or has power to 
                control, both of the business entities.
            ``(3) The term `biosimilar biological product' means a 
        product for which a biosimilar biological product application 
        has been approved.
            ``(4)(A) Subject to subparagraph (B), the term `biosimilar 
        biological product application' means an application for 
        licensure of a biological product under section 351(k) of the 
        Public Health Service Act.
            ``(B) Such term does not include--
                    ``(i) a supplement to such an application;
                    ``(ii) an application filed under section 351(k) of 
                the Public Health Service Act that cites as the 
                reference product a bovine blood product for topical 
                application licensed before September 1, 1992, or a 
                large volume parenteral drug product approved before 
                such date;
                    ``(iii) an application filed under section 351(k) 
                of the Public Health Service Act with respect to--
                            ``(I) whole blood or a blood component for 
                        transfusion;
                            ``(II) an allergenic extract product;
                            ``(III) an in vitro diagnostic biological 
                        product; or
                            ``(IV) a biological product for further 
                        manufacturing use only; or
                    ``(iv) an application for licensure under section 
                351(k) of the Public Health Service Act that is 
                submitted by a State or Federal Government entity for a 
                product that is not distributed commercially.
            ``(5) The term `biosimilar biological product development 
        meeting' means any meeting, other than a biosimilar initial 
        advisory meeting, regarding the content of a development 
        program, including a proposed design for, or data from, a study 
        intended to support a biosimilar biological product 
        application.
            ``(6) The term `biosimilar biological product development 
        program' means the program under this part for expediting the 
        process for the review of submissions in connection with 
        biosimilar biological product development.
            ``(7)(A) The term `biosimilar biological product 
        establishment' means a foreign or domestic place of business--
                    ``(i) that is at one general physical location 
                consisting of one or more buildings, all of which are 
                within five miles of each other; and
                    ``(ii) at which one or more biosimilar biological 
                products are manufactured in final dosage form.
            ``(B) For purposes of subparagraph (A)(ii), the term 
        `manufactured' does not include packaging.
            ``(8) The term `biosimilar initial advisory meeting'--
                    ``(A) means a meeting, if requested, that is 
                limited to--
                            ``(i) a general discussion regarding 
                        whether licensure under section 351(k) of the 
                        Public Health Service Act may be feasible for a 
                        particular product; and
                            ``(ii) if so, general advice on the 
                        expected content of the development program; 
                        and
                    ``(B) does not include any meeting that involves 
                substantive review of summary data or full study 
                reports.
            ``(9) The term `costs of resources allocated for the 
        process for the review of biosimilar biological product 
        applications' means the expenses in connection with the process 
        for the review of biosimilar biological product applications 
        for--
                    ``(A) officers and employees of the Food and Drug 
                Administration, contractors of the Food and Drug 
                Administration, advisory committees, and costs related 
                to such officers employees and committees and to 
                contracts with such contractors;
                    ``(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 744H and 
                accounting for resources allocated for the review of 
                submissions in connection with biosimilar biological 
                product development, biosimilar biological product 
                applications, and supplements.
            ``(10) The term `final dosage form' means, with respect to 
        a biosimilar biological product, a finished dosage form which 
        is approved for administration to a patient without substantial 
        further manufacturing (such as lyophilized products before 
        reconstitution).
            ``(11) The term `financial hold'--
                    ``(A) means an order issued by the Secretary to 
                prohibit the sponsor of a clinical investigation from 
                continuing the investigation if the Secretary 
                determines that the investigation is intended to 
                support a biosimilar biological product application and 
                the sponsor has failed to pay any fee for the product 
                required under subparagraph (A), (B), or (D) of section 
                744H(a)(1); and
                    ``(B) does not mean that any of the bases for a 
                `clinical hold' under section 505(i)(3) have been 
                determined by the Secretary to exist concerning the 
                investigation.
            ``(12) The term `person' includes an affiliate of such 
        person.
            ``(13) The term `process for the review of biosimilar 
        biological product applications' means the following activities 
        of the Secretary with respect to the review of submissions in 
        connection with biosimilar biological product development, 
        biosimilar biological product applications, and supplements:
                    ``(A) The activities necessary for the review of 
                submissions in connection with biosimilar biological 
                product development, biosimilar biological product 
                applications, and supplements.
                    ``(B) Actions related to submissions in connection 
                with biosimilar biological product development, the 
                issuance of action letters which approve biosimilar 
                biological product applications or which set forth in 
                detail the specific deficiencies in such applications, 
                and where appropriate, the actions necessary to place 
                such applications in condition for approval.
                    ``(C) The inspection of biosimilar biological 
                product establishments and other facilities undertaken 
                as part of the Secretary's review of pending biosimilar 
                biological product applications and supplements.
                    ``(D) Activities necessary for the release of lots 
                of biosimilar biological products under section 351(k) 
                of the Public Health Service Act.
                    ``(E) Monitoring of research conducted in 
                connection with the review of biosimilar biological 
                product applications.
                    ``(F) Postmarket safety activities with respect to 
                biologics approved under biosimilar biological product 
                applications or supplements, including the following 
                activities:
                            ``(i) Collecting, developing, and reviewing 
                        safety information on biosimilar biological 
                        products, including adverse event reports.
                            ``(ii) Developing and using improved 
                        adverse-event data-collection systems, 
                        including information technology systems.
                            ``(iii) Developing and using improved 
                        analytical tools to assess potential safety 
                        problems, including access to external data 
                        bases.
                            ``(iv) Implementing and enforcing section 
                        505(o) (relating to postapproval studies and 
                        clinical trials and labeling changes) and 
                        section 505(p) (relating to risk evaluation and 
                        mitigation strategies).
                            ``(v) Carrying out section 505(k)(5) 
                        (relating to adverse event reports and 
                        postmarket safety activities).
            ``(14) The term `supplement' means a request to the 
        Secretary to approve a change in a biosimilar biological 
        product application which has been approved, including a 
        supplement requesting that the Secretary determine that the 
        biosimilar biological product meets the standards for 
        interchangeability described in section 351(k)(4) of the Public 
        Health Service Act.

``SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL PRODUCT 
              FEES.

    ``(a) Types of Fees.--Beginning in fiscal year 2013, the Secretary 
shall assess and collect fees in accordance with this section as 
follows:
            ``(1) Biosimilar development program fees.--
                    ``(A) Initial biosimilar biological product 
                development fee.--
                            ``(i) In general.--Each person that submits 
                        to the Secretary a meeting request described 
                        under clause (ii) or a clinical protocol for an 
                        investigational new drug protocol described 
                        under clause (iii) shall pay for the product 
                        named in the meeting request or the 
                        investigational new drug application the 
                        initial biosimilar biological product 
                        development fee established under subsection 
                        (b)(1)(A).
                            ``(ii) Meeting request.--The meeting 
                        request defined in this clause is a request for 
                        a biosimilar biological product development 
                        meeting for a product.
                            ``(iii) Clinical protocol for ind.--A 
                        clinical protocol for an investigational new 
                        drug protocol described in this clause is a 
                        clinical protocol consistent with the 
                        provisions of section 505(i), including any 
                        regulations promulgated under section 505(i), 
                        (referred to in this section as 
                        `investigational new drug application') 
                        describing an investigation that the Secretary 
                        determines is intended to support a biosimilar 
                        biological product application for a product.
                            ``(iv) Due date.--The initial biosimilar 
                        biological product development fee shall be due 
                        by the earlier of the following:
                                    ``(I) Not later than 5 days after 
                                the Secretary grants a request for a 
                                biosimilar biological product 
                                development meeting.
                                    ``(II) The date of submission of an 
                                investigational new drug application 
                                describing an investigation that the 
                                Secretary determines is intended to 
                                support a biosimilar biological product 
                                application.
                            ``(v) Transition rule.--Each person that 
                        has submitted an investigational new drug 
                        application prior to the date of enactment of 
                        the Biosimilars User Fee Act of 2012 shall pay 
                        the initial biosimilar biological product 
                        development fee by the earlier of the 
                        following:
                                    ``(I) Not later than 60 days after 
                                the date of the enactment of the 
                                Biosimilars User Fee Act of 2012, if 
                                the Secretary determines that the 
                                investigational new drug application 
                                describes an investigation that is 
                                intended to support a biosimilar 
                                biological product application.
                                    ``(II) Not later than 5 days after 
                                the Secretary grants a request for a 
                                biosimilar biological product 
                                development meeting.
                    ``(B) Annual biosimilar biological product 
                development fee.--
                            ``(i) In general.--A person that pays an 
                        initial biosimilar biological product 
                        development fee for a product shall pay for 
                        such product, beginning in the fiscal year 
                        following the fiscal year in which the initial 
                        biosimilar biological product development fee 
                        was paid, an annual fee established under 
                        subsection (b)(1)(B) for biosimilar biological 
                        product development (referred to in this 
                        section as `annual biosimilar biological 
                        product development fee').
                            ``(ii) Due date.--The annual biosimilar 
                        biological product development program fee for 
                        each fiscal year will be due on the later of--
                                    ``(I) the first business day on or 
                                after October 1 of each such year; or
                                    ``(II) the first business day after 
                                the enactment of an appropriations Act 
                                providing for the collection and 
                                obligation of fees for such year under 
                                this section.
                            ``(iii) Exception.--The annual biosimilar 
                        development program fee for each fiscal year 
                        will be due on the date specified in clause 
                        (ii), unless the person has--
                                    ``(I) submitted a marketing 
                                application for the biological product 
                                that was accepted for filing; or
                                    ``(II) discontinued participation 
                                in the biosimilar biological product 
                                development program for the product 
                                under subparagraph (C).
                    ``(C) Discontinuation of fee obligation.--A person 
                may discontinue participation in the biosimilar 
                biological product development program for a product 
                effective October 1 of a fiscal year by, not later than 
                August 1 of the preceding fiscal year--
                            ``(i) if no investigational new drug 
                        application concerning the product has been 
                        submitted, submitting to the Secretary a 
                        written declaration that the person has no 
                        present intention of further developing the 
                        product as a biosimilar biological product; or
                            ``(ii) if an investigational new drug 
                        application concerning the product has been 
                        submitted, by withdrawing the investigational 
                        new drug application in accordance with part 
                        312 of title 21, Code of Federal Regulations 
                        (or any successor regulations).
                    ``(D) Reactivation fee.--
                            ``(i) In general.--A person that has 
                        discontinued participation in the biosimilar 
                        biological product development program for a 
                        product under subparagraph (C) shall pay a fee 
                        (referred to in this section as `reactivation 
                        fee') by the earlier of the following:
                                    ``(I) Not later than 5 days after 
                                the Secretary grants a request for a 
                                biosimilar biological product 
                                development meeting for the product 
                                (after the date on which such 
                                participation was discontinued).
                                    ``(II) Upon the date of submission 
                                (after the date on which such 
                                participation was discontinued) of an 
                                investigational new drug application 
                                describing an investigation that the 
                                Secretary determines is intended to 
                                support a biosimilar biological product 
                                application for that product.
                            ``(ii) Application of annual fee.--A person 
                        that pays a reactivation fee for a product 
                        shall pay for such product, beginning in the 
                        next fiscal year, the annual biosimilar 
                        biological product development fee under 
                        subparagraph (B).
                    ``(E) Effect of failure to pay biosimilar 
                development program fees.--
                            ``(i) No biosimilar biological product 
                        development meetings.--If a person has failed 
                        to pay an initial or annual biosimilar 
                        biological product development fee as required 
                        under subparagraph (A) or (B), or a 
                        reactivation fee as required under subparagraph 
                        (D), the Secretary shall not provide a 
                        biosimilar biological product development 
                        meeting relating to the product for which fees 
                        are owed.
                            ``(ii) No receipt of investigational new 
                        drug applications.--Except in extraordinary 
                        circumstances, the Secretary shall not consider 
                        an investigational new drug application to have 
                        been received under section 505(i)(2) if--
                                    ``(I) the Secretary determines that 
                                the investigation is intended to 
                                support a biosimilar biological product 
                                application; and
                                    ``(II) the sponsor has failed to 
                                pay an initial or annual biosimilar 
                                biological product development fee for 
                                the product as required under 
                                subparagraph (A) or (B), or a 
                                reactivation fee as required under 
                                subparagraph (D).
                            ``(iii) Financial hold.--Notwithstanding 
                        section 505(i)(2), except in extraordinary 
                        circumstances, the Secretary shall prohibit the 
                        sponsor of a clinical investigation from 
                        continuing the investigation if--
                                    ``(I) the Secretary determines that 
                                the investigation is intended to 
                                support a biosimilar biological product 
                                application; and
                                    ``(II) the sponsor has failed to 
                                pay an initial or annual biosimilar 
                                biological product development fee for 
                                the product as required under 
                                subparagraph (A) or (B), or a 
                                reactivation fee for the product as 
                                required under subparagraph (D).
                            ``(iv) No acceptance of biosimilar 
                        biological product applications or 
                        supplements.--If a person has failed to pay an 
                        initial or annual biosimilar biological product 
                        development fee as required under subparagraph 
                        (A) or (B), or a reactivation fee as required 
                        under subparagraph (D), any biosimilar 
                        biological product application or supplement 
                        submitted by that person shall be considered 
                        incomplete and shall not be accepted for filing 
                        by the Secretary until all such fees owed by 
                        such person have been paid.
                    ``(F) Limits regarding biosimilar development 
                program fees.--
                            ``(i) No refunds.--The Secretary shall not 
                        refund any initial or annual biosimilar 
                        biological product development fee paid under 
                        subparagraph (A) or (B), or any reactivation 
                        fee paid under subparagraph (D).
                            ``(ii) No waivers, exemptions, or 
                        reductions.--The Secretary shall not grant a 
                        waiver, exemption, or reduction of any initial 
                        or annual biosimilar biological product 
                        development fee due or payable under 
                        subparagraph (A) or (B), or any reactivation 
                        fee due or payable under subparagraph (D).
            ``(2) Biosimilar biological product application and 
        supplement fee.--
                    ``(A) In general.--Each person that submits, on or 
                after October 1, 2012, a biosimilar biological product 
                application or a supplement shall be subject to the 
                following fees:
                            ``(i) A fee for a biosimilar biological 
                        product application that is equal to--
                                    ``(I) the amount of the fee 
                                established under subsection (b)(1)(D) 
                                for a biosimilar biological product 
                                application; minus
                                    ``(II) the cumulative amount of 
                                fees paid, if any, under subparagraphs 
                                (A), (B), and (D) of paragraph (1) for 
                                the product that is the subject of the 
                                application.
                            ``(ii) A fee for a biosimilar biological 
                        product application for which clinical data 
                        (other than comparative bioavailability 
                        studies) with respect to safety or 
                        effectiveness are not required, that is equal 
                        to--
                                    ``(I) half of the amount of the fee 
                                established under subsection (b)(1)(D) 
                                for a biosimilar biological product 
                                application; minus
                                    ``(II) the cumulative amount of 
                                fees paid, if any, under subparagraphs 
                                (A), (B), and (D) of paragraph (1) for 
                                that product.
                            ``(iii) A fee for a supplement for which 
                        clinical data (other than comparative 
                        bioavailability studies) with respect to safety 
                        or effectiveness are required, that is equal to 
                        half of the amount of the fee established under 
                        subsection (b)(1)(D) for a biosimilar 
                        biological product application.
                    ``(B) Reduction in fees.--Notwithstanding section 
                204 of the Biosimilars User Fee Act of 2012, any person 
                who pays a fee under subparagraph (A), (B), or (D) of 
                paragraph (1) for a product before October 1, 2017, but 
                submits a biosimilar biological product application for 
                that product after such date, shall be entitled to the 
                reduction of any biosimilar biological product 
                application fees that may be assessed at the time when 
                such biosimilar biological product application is 
                submitted, by the cumulative amount of fees paid under 
                subparagraphs (A), (B), and (D) of paragraph (1) for 
                that product.
                    ``(C) Payment due date.--Any fee required by 
                subparagraph (A) shall be due upon submission of the 
                application or supplement for which such fee applies.
                    ``(D) Exception for previously filed application or 
                supplement.--If a biosimilar biological product 
                application or supplement 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), the submission of a 
                biosimilar biological product application or a 
                supplement 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).
                    ``(E) Refund of application fee if application 
                refused for filing or withdrawn before filing.--The 
                Secretary shall refund 75 percent of the fee paid under 
                this paragraph for any application or supplement which 
                is refused for filing or withdrawn without a waiver 
                before filing.
                    ``(F) Fees for applications previously refused for 
                filing or withdrawn before filing.--A biosimilar 
                biological product application or supplement that was 
                submitted but was refused for filing, or was withdrawn 
                before being accepted or refused for filing, shall be 
                subject to the full fee under subparagraph (A) upon 
                being resubmitted or filed over protest, unless the fee 
                is waived under subsection (c).
            ``(3) Biosimilar biological product establishment fee.--
                    ``(A) In general.--Except as provided in 
                subparagraph (E)(ii), each person that is named as the 
                applicant in a biosimilar biological product 
                application shall be assessed an annual fee established 
                under subsection (b)(1)(E) for each biosimilar 
                biological product establishment that is listed in the 
                approved biosimilar biological product application as 
                an establishment that manufactures the biosimilar 
                biological product named in such application.
                    ``(B) Assessment in fiscal years.--The 
                establishment fee shall be assessed in each fiscal year 
                for which the biosimilar biological product named in 
                the application is assessed a fee under paragraph (4) 
                unless the biosimilar biological product establishment 
                listed in the application does not engage in the 
                manufacture of the biosimilar biological product during 
                such fiscal year.
                    ``(C) Due date.--The establishment fee for a fiscal 
                year shall be due on the later of--
                            ``(i) the first business day on or after 
                        October 1 of such fiscal year; or
                            ``(ii) the first business day after the 
                        enactment of an appropriations Act providing 
                        for the collection and obligation of fees for 
                        such fiscal year under this section.
                    ``(D) Application to establishment.--
                            ``(i) Each biosimilar biological product 
                        establishment shall be assessed only one fee 
                        per biosimilar biological product 
                        establishment, notwithstanding the number of 
                        biosimilar biological products manufactured at 
                        the establishment, subject to clause (ii).
                            ``(ii) In the event an establishment is 
                        listed in a biosimilar biological product 
                        application by more than one applicant, the 
                        establishment fee for the fiscal year shall be 
                        divided equally and assessed among the 
                        applicants whose biosimilar biological products 
                        are manufactured by the establishment during 
                        the fiscal year and assessed biosimilar 
                        biological product fees under paragraph (4).
                    ``(E) Exception for new products.--If, during the 
                fiscal year, an applicant initiates or causes to be 
                initiated the manufacture of a biosimilar biological 
                product at an establishment listed in its biosimilar 
                biological product application--
                            ``(i) that did not manufacture the 
                        biosimilar biological product in the previous 
                        fiscal year; and
                            ``(ii) for which the full biosimilar 
                        biological product establishment fee has been 
                        assessed in the fiscal year at a time before 
                        manufacture of the biosimilar biological 
                        product was begun,
                the applicant shall not be assessed a share of the 
                biosimilar biological product establishment fee for the 
                fiscal year in which the manufacture of the product 
                began.
            ``(4) Biosimilar biological product fee.--
                    ``(A) In general.--Each person who is named as the 
                applicant in a biosimilar biological product 
                application shall pay for each such biosimilar 
                biological product the annual fee established under 
                subsection (b)(1)(F).
                    ``(B) Due date.--The biosimilar biological product 
                fee for a fiscal year shall be due on the later of--
                            ``(i) the first business day on or after 
                        October 1 of each such year; or
                            ``(ii) the first business day after the 
                        enactment of an appropriations Act providing 
                        for the collection and obligation of fees for 
                        such year under this section.
                    ``(C) One fee per product per year.--The biosimilar 
                biological product fee shall be paid only once for each 
                product for each fiscal year.
    ``(b) Fee Setting and Amounts.--
            ``(1) In general.--Subject to paragraph (2), the Secretary 
        shall, 60 days before the start of each fiscal year that begins 
        after September 30, 2012, establish, for the next fiscal year, 
        the fees under subsection (a). Except as provided in subsection 
        (c), such fees shall be in the following amounts:
                    ``(A) Initial biosimilar biological product 
                development fee.--The initial biosimilar biological 
                product development fee under subsection (a)(1)(A) for 
                a fiscal year shall be equal to 10 percent of the 
                amount established under section 736(c)(5) for a human 
                drug application described in section 736(a)(1)(A)(i) 
                for that fiscal year.
                    ``(B) Annual biosimilar biological product 
                development fee.--The annual biosimilar biological 
                product development fee under subsection (a)(1)(B) for 
                a fiscal year shall be equal to 10 percent of the 
                amount established under section 736(c)(5) for a human 
                drug application described in section 736(a)(1)(A)(i) 
                for that fiscal year.
                    ``(C) Reactivation fee.--The reactivation fee under 
                subsection (a)(1)(D) for a fiscal year shall be equal 
                to 20 percent of the amount of the fee established 
                under section 736(c)(5) for a human drug application 
                described in section 736(a)(1)(A)(i) for that fiscal 
                year.
                    ``(D) Biosimilar biological product application 
                fee.--The biosimilar biological product application fee 
                under subsection (a)(2) for a fiscal year shall be 
                equal to the amount established under section 736(c)(5) 
                for a human drug application described in section 
                736(a)(1)(A)(i) for that fiscal year.
                    ``(E) Biosimilar biological product establishment 
                fee.--The biosimilar biological product establishment 
                fee under subsection (a)(3) for a fiscal year shall be 
                equal to the amount established under section 736(c)(5) 
                for a prescription drug establishment for that fiscal 
                year.
                    ``(F) Biosimilar biological product fee.--The 
                biosimilar biological product fee under subsection 
                (a)(4) for a fiscal year shall be equal to the amount 
                established under section 736(c)(5) for a prescription 
                drug product for that fiscal year.
            ``(2) Limit.--The total amount of fees charged for a fiscal 
        year under this section may not exceed the total amount for 
        such fiscal year of the costs of resources allocated for the 
        process for the review of biosimilar biological product 
        applications.
    ``(c) Application Fee Waiver for Small Business.--
            ``(1) Waiver of application fee.--The Secretary shall grant 
        to a person who is named in a biosimilar biological product 
        application a waiver from the application fee assessed to that 
        person under subsection (a)(2)(A) for the first biosimilar 
        biological product 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--
                    ``(A) application fees for all subsequent 
                biosimilar biological product applications submitted to 
                the Secretary for review in the same manner as an 
                entity that is not a small business; and
                    ``(B) all supplement fees for all supplements to 
                biosimilar biological product applications submitted to 
                the Secretary for review in the same manner as an 
                entity that is not a small business.
            ``(2) Considerations.--In determining whether to grant a 
        waiver of a fee under paragraph (1), the Secretary shall 
        consider only the circumstances and assets of the applicant 
        involved and any affiliate of the applicant.
            ``(3) Small business defined.--In this subsection, the term 
        `small business' means an entity that has fewer than 500 
        employees, including employees of affiliates, and does not have 
        a drug product that has been approved under a human drug 
        application (as defined in section 735) or a biosimilar 
        biological product application (as defined in section 744G(4)) 
        and introduced or delivered for introduction into interstate 
        commerce.
    ``(d) Effect of Failure To Pay Fees.--A biosimilar biological 
product application or supplement 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.
    ``(e) Crediting and Availability of Fees.--
            ``(1) In general.--Subject to paragraph (2), 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 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 salaries and expenses with such fiscal year limitation. The 
        sums transferred shall be available solely for the process for 
        the review of biosimilar biological product applications.
            ``(2) Collections and appropriation acts.--
                    ``(A) In general.--Subject to subparagraphs (C) and 
                (D), the fees authorized by this section 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.
                    ``(B) Use of fees and limitation.--The fees 
                authorized by this section shall be available for a 
                fiscal year beginning after fiscal year 2012 to defray 
                the costs of the process for the review of biosimilar 
                biological product applications (including 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), only if the 
                Secretary allocates for such purpose an amount for such 
                fiscal year (excluding amounts from fees collected 
                under this section) no less than $20,000,000, 
                multiplied by the adjustment factor applicable to the 
                fiscal year involved.
                    ``(C) Fee collection during first program year.--
                Until the date of enactment of an Act making 
                appropriations through September 30, 2013, for the 
                salaries and expenses account of the Food and Drug 
                Administration, fees authorized by this section for 
                fiscal year 2013 may be collected and shall be credited 
                to such account and remain available until expended.
                    ``(D) Provision for early payments in subsequent 
                years.--Payment of fees authorized under this section 
                for a fiscal year (after fiscal year 2013), 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 fiscal 
        years 2013 through 2017, there is authorized to be appropriated 
        for fees under this section an amount equivalent to the total 
        amount of fees assessed for such fiscal year under this 
        section.
    ``(f) 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.
    ``(g) Written Requests for Waivers and Refunds.--To qualify for 
consideration for a waiver under subsection (c), or for a refund of any 
fee collected in accordance with subsection (a)(2)(A), a person shall 
submit to the Secretary a written request for such waiver or refund not 
later than 180 days after such fee is due.
    ``(h) 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, employers, and advisory 
committees not engaged in the process of the review of biosimilar 
biological product applications, be reduced to offset the number of 
officers, employees, and advisory committees so engaged.''.

SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS.

    Part 8 of subchapter C of chapter VII, as amended by section 202 of 
this Act, is further amended by inserting after section 744H the 
following:

``SEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS.

    ``(a) Performance Report.--Beginning with fiscal year 2013, not 
later than 120 days after the end of each fiscal year for which fees 
are collected under this part, the Secretary shall prepare and submit 
to the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate a report concerning the progress of the Food and Drug 
Administration in achieving the goals identified in the letters 
described in section 201(c) of the Biosimilars User Fee Act of 2012 
during such fiscal year and the future plans of the Food and Drug 
Administration for meeting such goals. The report for a fiscal year 
shall include information on all previous cohorts for which the 
Secretary has not given a complete response on all biosimilar 
biological product applications and supplements in the cohort.
    ``(b) Fiscal Report.--Not later than 120 days after the end of 
fiscal year 2013 and each subsequent fiscal year for which fees are 
collected under this part, the Secretary shall prepare and submit to 
the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate 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 for such fiscal year.
    ``(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) Study.--
            ``(1) In general.--The Secretary shall contract with an 
        independent accounting or consulting firm to study the workload 
        volume and full costs associated with the process for the 
        review of biosimilar biological product applications.
            ``(2) Interim results.--Not later than June 1, 2015, the 
        Secretary shall publish, for public comment, interim results of 
        the study described under paragraph (1).
            ``(3) Final results.--Not later than September 30, 2016, 
        the Secretary shall publish, for public comment, the final 
        results of the study described under paragraph (1).
    ``(e) Reauthorization.--
            ``(1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals described in 
        subsection (a), and plans for meeting the goals, for the 
        process for the review of biosimilar biological product 
        applications for the first 5 fiscal years after fiscal year 
        2017, 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) health care professionals;
                    ``(E) representatives of patient and consumer 
                advocacy groups; and
                    ``(F) the regulated industry.
            ``(2) 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.
            ``(3) Transmittal of recommendations.--Not later than 
        January 15, 2017, the Secretary shall transmit to the Congress 
        the revised recommendations under paragraph (2), 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.''.

SEC. 204. SUNSET DATES.

    (a) Authorization.--The amendment made by section 202 shall cease 
to be effective October 1, 2017.
    (b) Reporting Requirements.--The amendment made by section 203 
shall cease to be effective January 31, 2018.

SEC. 205. EFFECTIVE DATE.

    (a) In General.--Except as provided under subsection (b), the 
amendments made by this title shall take effect on the later of--
            (1) October 1, 2012; or
            (2) the date of the enactment of this title.
    (b) Exception.--Fees under part 7 of subchapter C of chapter VII of 
the Federal Food, Drug, and Cosmetic Act, as added by this title, shall 
be assessed for all biosimilar biological product applications received 
on or after October 1, 2012, regardless of the date of the enactment of 
this title.

SEC. 206. SAVINGS CLAUSE.

    Notwithstanding section 106 of the Prescription Drug User Fee 
Amendments of 2007 (21 U.S.C. 379g note), and notwithstanding the 
amendments made by this title, part 2 of subchapter C of chapter VII of 
the Federal Food, Drug, and Cosmetic Act, as in effect on the day 
before the date of the enactment of this title, shall continue to be in 
effect with respect to human drug applications and supplements (as 
defined in such part as of such day) that were accepted by the Food and 
Drug Administration for filing on or after October 1, 2007, but before 
October 1, 2012, with respect to assessing and collecting any fee 
required by such part for a fiscal year prior to fiscal year 2013.

SEC. 207. TECHNICAL AMENDMENT; CONFORMING AMENDMENT.

    Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amended by striking 
``or (k)''.
                                 <all>
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