One Hundred Twelfth Congress
`of the
`United States of America
`
`AT THE SECOND SESSION
`
`Begun and held at the City of Washington on Tuesday,
`the third day of January, two thousand and twelve
`
`An Act
`
`To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the
`user-fee programs for prescription drugs and medical devices, to establish user-
`fee programs for generic drugs and biosimilars, and for other purposes.
`
`Be it enacted by the Senate and House of Representatives of
`the United States of America in Congress assembled,
`SECTION 1. SHORT TITLE.
`This Act may be cited as the ‘‘Food and Drug Administration
`Safety and Innovation Act’’.
`SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.
`(a) TABLE OF CONTENTS.—The table of contents of this Act
`is as follows:
`Sec. 1. Short title.
`Sec. 2. Table of contents; references in Act.
`TITLE I—FEES RELATING TO DRUGS
`Sec. 101. Short title; finding.
`Sec. 102. Definitions.
`Sec. 103. Authority to assess and use drug fees.
`Sec. 104. Reauthorization; reporting requirements.
`Sec. 105. Sunset dates.
`Sec. 106. Effective date.
`Sec. 107. Savings clause.
`TITLE II—FEES RELATING TO DEVICES
`Sec. 201. Short title; findings.
`Sec. 202. Definitions.
`Sec. 203. Authority to assess and use device fees.
`Sec. 204. Reauthorization; reporting requirements.
`Sec. 205. Savings clause.
`Sec. 206. Effective date.
`Sec. 207. Sunset clause.
`Sec. 208. Streamlined hiring authority to support activities related to the process
`for the review of device applications.
`TITLE III—FEES RELATING TO GENERIC DRUGS
`Sec. 301. Short title.
`Sec. 302. Authority to assess and use human generic drug fees.
`Sec. 303. Reauthorization; reporting requirements.
`Sec. 304. Sunset dates.
`Sec. 305. Effective date.
`Sec. 306. Amendment with respect to misbranding.
`Sec. 307. Streamlined hiring authority to support activities related to human ge-
`neric drugs.
`Sec. 308. Additional reporting requirements.
`TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
`Sec. 401. Short title; finding.
`Sec. 402. Fees relating to biosimilar biological products.
`
`Exhibit 2007 Page 001
`
`Pharmacyclics LLC - Ex. 2007
`Coalition for Affordable Drugs IV LLC v. Pharmacyclics LLC
`Case IPR2015-01076
`
`

`

`S. 3187—2
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`Sec. 403. Reauthorization; reporting requirements.
`Sec. 404. Sunset dates.
`Sec. 405. Effective date.
`Sec. 406. Savings clause.
`Sec. 407. Conforming amendment.
`Sec. 408. Additional reporting requirements.
`TITLE V—PEDIATRIC DRUGS AND DEVICES
`Sec. 501. Permanence.
`Sec. 502. Written requests.
`Sec. 503. Communication with Pediatric Review Committee.
`Sec. 504. Access to data.
`Sec. 505. Ensuring the completion of pediatric studies.
`Sec. 506. Pediatric study plans.
`Sec. 507. Reauthorizations.
`Sec. 508. Report.
`Sec. 509. Technical amendments.
`Sec. 510. Pediatric rare diseases.
`Sec. 511. Staff of Office of Pediatric Therapeutics.
`TITLE VI—MEDICAL DEVICE REGULATORY IMPROVEMENTS
`Sec. 601. Investigational device exemptions.
`Sec. 602. Clarification of least burdensome standard.
`Sec. 603. Agency documentation and review of significant decisions.
`Sec. 604. Device modifications requiring premarket notification prior to marketing.
`Sec. 605. Program to improve the device recall system.
`Sec. 606. Clinical holds on investigational device exemptions.
`Sec. 607. Modification of de novo application process.
`Sec. 608. Reclassification procedures.
`Sec. 609. Harmonization of device premarket review, inspection, and labeling sym-
`bols.
`Sec. 610. Participation in international fora.
`Sec. 611. Reauthorization of third-party review.
`Sec. 612. Reauthorization of third-party inspection.
`Sec. 613. Humanitarian device exemptions.
`Sec. 614. Unique device identifier.
`Sec. 615. Sentinel.
`Sec. 616. Postmarket surveillance.
`Sec. 617. Custom devices.
`Sec. 618. Health information technology.
`Sec. 619. Good guidance practices relating to devices.
`Sec. 620. Pediatric device consortia.
`TITLE VII—DRUG SUPPLY CHAIN
`Sec. 701. Registration of domestic drug establishments.
`Sec. 702. Registration of foreign establishments.
`Sec. 703. Identification of drug excipient information with product listing.
`Sec. 704. Electronic system for registration and listing.
`Sec. 705. Risk-based inspection frequency.
`Sec. 706. Records for inspection.
`Sec. 707. Prohibition against delaying, denying, limiting, or refusing inspection.
`Sec. 708. Destruction of adulterated, misbranded, or counterfeit drugs offered for
`import.
`Sec. 709. Administrative detention.
`Sec. 710. Exchange of information.
`Sec. 711. Enhancing the safety and quality of the drug supply.
`Sec. 712. Recognition of foreign government inspections.
`Sec. 713. Standards for admission of imported drugs.
`Sec. 714. Registration of commercial importers.
`Sec. 715. Notification.
`Sec. 716. Protection against intentional adulteration.
`Sec. 717. Penalties for counterfeiting drugs.
`Sec. 718. Extraterritorial jurisdiction.
`TITLE VIII—GENERATING ANTIBIOTIC INCENTIVES NOW
`Sec. 801. Extension of exclusivity period for drugs.
`Sec. 802. Priority review.
`Sec. 803. Fast track product.
`Sec. 804. Clinical trials.
`Sec. 805. Reassessment of qualified infectious disease product incentives in 5 years.
`Sec. 806. Guidance on pathogen-focused antibacterial drug development.
`
`Exhibit 2007 Page 002
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`S. 3187—3
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`TITLE IX—DRUG APPROVAL AND PATIENT ACCESS
`Sec. 901. Enhancement of accelerated patient access to new medical treatments.
`Sec. 902. Breakthrough therapies.
`Sec. 903. Consultation with external experts on rare diseases, targeted therapies,
`and genetic targeting of treatments.
`Sec. 904. Accessibility of information on prescription drug container labels by vis-
`ually impaired and blind consumers.
`Sec. 905. Risk-benefit framework.
`Sec. 906. Grants and Contracts for the Development of Orphan Drugs.
`Sec. 907. Reporting of inclusion of demographic subgroups in clinical trials and
`data analysis in applications for drugs, biologics, and devices.
`Sec. 908. Rare pediatric disease priority review voucher incentive program.
`TITLE X—DRUG SHORTAGES
`Sec. 1001. Discontinuance or interruption in the production of life-saving drugs.
`Sec. 1002. Annual reporting on drug shortages.
`Sec. 1003. Coordination; task force and strategic plan.
`Sec. 1004. Drug shortage list.
`Sec. 1005. Quotas applicable to drugs in shortage.
`Sec. 1006. Attorney General report on drug shortages.
`Sec. 1007. Hospital repackaging of drugs in shortage.
`Sec. 1008. Study on drug shortages.
`TITLE XI—OTHER PROVISIONS
`Subtitle A—Reauthorizations
`Sec. 1101. Reauthorization of provision relating to exclusivity of certain drugs con-
`taining single enantiomers.
`Sec. 1102. Reauthorization of the critical path public-private partnerships.
`Subtitle B—Medical Gas Product Regulation
`Sec. 1111. Regulation of medical gases.
`Sec. 1112. Changes to regulations.
`Sec. 1113. Rules of construction.
`Subtitle C—Miscellaneous Provisions
`Sec. 1121. Guidance document regarding product promotion using the Internet.
`Sec. 1122. Combating prescription drug abuse.
`Sec. 1123. Optimizing global clinical trials.
`Sec. 1124. Advancing regulatory science to promote public health innovation.
`Sec. 1125. Information technology.
`Sec. 1126. Nanotechnology.
`Sec. 1127. Online pharmacy report to Congress.
`Sec. 1128. Report on small businesses.
`Sec. 1129. Protections for the commissioned corps of the public health service act.
`Sec. 1130. Compliance date for rule relating to sunscreen drug products for over-
`the-counter human use.
`Sec. 1131. Strategic integrated management plan.
`Sec. 1132. Assessment and modification of REMS.
`Sec. 1133. Extension of period for first applicant to obtain tentative approval with-
`out forfeiting 180-day-exclusivity period.
`Sec. 1134. Deadline for determination on certain petitions.
`Sec. 1135. Final agency action relating to petitions and civil actions.
`Sec. 1136. Electronic submission of applications.
`Sec. 1137. Patient participation in medical product discussions.
`Sec. 1138. Ensuring adequate information regarding pharmaceuticals for all popu-
`lations, particularly underrepresented subpopulations, including racial
`subgroups.
`Sec. 1139. Scheduling of hydrocodone.
`Sec. 1140. Study on Drug Labeling by Electronic Means.
`Sec. 1141. Recommendations on interoperability standards.
`Sec. 1142. Conflicts of interest.
`Sec. 1143. Notification of FDA intent to regulate laboratory-developed tests.
`Subtitle D—Synthetic Drugs
`
`Sec. 1151. Short title.
`Sec. 1152. Addition of synthetic drugs to schedule I of the Controlled Substances
`Act.
`Sec. 1153. Temporary scheduling to avoid imminent hazards to public safety expan-
`sion.
`
`Exhibit 2007 Page 003
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`(b) REFERENCES IN ACT.—Except as otherwise specified, amend-
`ments made by this Act to a section or other provision of law
`are amendments to such section or other provision of the Federal
`Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
`TITLE I—FEES RELATING TO DRUGS
`
`SEC. 101. SHORT TITLE; FINDING.
`(a) SHORT TITLE.—This title may be cited as the ‘‘Prescription
`Drug User Fee Amendments of 2012’’.
`(b) FINDING.—The Congress finds that the fees authorized by
`the amendments made in this title will be dedicated toward expe-
`diting the drug development process and the process for the review
`of human drug applications, including postmarket drug safety
`activities, as set forth in the goals identified for purposes of part
`2 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 Rep-
`resentatives, as set forth in the Congressional Record.
`SEC. 102. DEFINITIONS.
`Section 735(7) (21 U.S.C. 379g) is amended by striking
`‘‘expenses incurred in connection with’’ and inserting ‘‘expenses
`in connection with’’.
`SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.
`Section 736 (21 U.S.C. 379h) is amended—
`(1) in subsection (a)—
`(A) in the matter preceding paragraph (1), by striking
`‘‘fiscal year 2008’’ and inserting ‘‘fiscal year 2013’’;
`(B) in paragraph (1)(A)—
`(i) in clause (i), by striking ‘‘(c)(5)’’ and inserting
`‘‘(c)(4)’’; and
`(ii) in clause (ii), by striking ‘‘(c)(5)’’ and inserting
`‘‘(c)(4)’’;
`(C) in the matter following clause (ii) in paragraph
`(2)(A)—
`
`(i) by striking ‘‘(c)(5)’’ and inserting ‘‘(c)(4)’’; and
`(ii) by striking ‘‘payable on or before October 1
`of each year’’ and inserting ‘‘due on the later of the
`first business day on or after October 1 of each fiscal
`year or 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) in paragraph (3)—
`(i) in subparagraph (A)—
`(I) by striking ‘‘subsection (c)(5)’’ and inserting
`‘‘subsection (c)(4)’’; and
`(II) by striking ‘‘payable on or before October
`1 of each year.’’ and inserting ‘‘due on the later
`of the first business day on or after October 1
`of each fiscal year or the first business day after
`the enactment of an appropriations Act providing
`
`Exhibit 2007 Page 004
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`S. 3187—5
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`for the collection and obligation of fees for such
`fiscal year under this section.’’; and
`(ii) by amending subparagraph (B) to read as fol-
`lows:
`‘‘(B) EXCEPTION.—A prescription drug product shall not
`be assessed a fee under subparagraph (A) if such product
`is—
`
`‘‘(i) identified on the list compiled under section
`505(j)(7) with a potency described in terms of per 100
`mL;
`‘‘(ii) the same product as another product that—
`‘‘(I) was approved under an application filed
`under section 505(b) or 505(j); and
`‘‘(II) is not in the list of discontinued products
`compiled under section 505(j)(7);
`‘‘(iii) the same product as another product that
`was approved under an abbreviated application filed
`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
`‘‘(iv) the same product as another product that
`was approved under an abbreviated new drug applica-
`tion pursuant to regulations in effect prior to the
`implementation of the Drug Price Competition and
`Patent Term Restoration Act of 1984.’’;
`(2) in subsection (b)—
`(A) in paragraph (1)—
`(i) in the matter preceding subparagraph (A), by
`striking ‘‘fiscal years 2008 through 2012’’ and inserting
`‘‘fiscal years 2013 through 2017’’;
`(ii) in subparagraph (A), by striking ‘‘$392,783,000;
`and’’ and inserting ‘‘$693,099,000;’’; and
`(iii) by striking subparagraph (B) and inserting
`the following:
`‘‘(B) the dollar amount equal to the inflation adjust-
`ment for fiscal year 2013 (as determined under paragraph
`(3)(A)); and
`‘‘(C) the dollar amount equal to the workload adjust-
`ment for fiscal year 2013 (as determined under paragraph
`(3)(B)).’’; and
`(B) by striking paragraphs (3) and (4) and inserting
`the following:
`‘‘(3) FISCAL YEAR 2013 INFLATION AND WORKLOAD ADJUST-
`MENTS.—For purposes of paragraph (1), the dollar amount of
`the inflation and workload adjustments for fiscal year 2013
`shall be determined as follows:
`‘‘(A) INFLATION ADJUSTMENT.—The inflation adjust-
`ment for fiscal year 2013 shall be the sum of—
`‘‘(i) $652,709,000 multiplied by the result of an
`inflation adjustment calculation determined using the
`methodology described in subsection (c)(1)(B); and
`‘‘(ii) $652,709,000 multiplied by the result of an
`inflation adjustment calculation determined using the
`methodology described in subsection (c)(1)(C).
`‘‘(B) WORKLOAD ADJUSTMENT.—Subject to subpara-
`graph (C), the workload adjustment for fiscal 2013 shall
`be—
`
`Exhibit 2007 Page 005
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`S. 3187—6
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`‘‘(i) $652,709,000 plus the amount of the inflation
`adjustment calculated under subparagraph (A); multi-
`plied by
`‘‘(ii) the amount (if any) by which a percentage
`workload adjustment for fiscal year 2013, as deter-
`mined using the methodology described in subsection
`(c)(2)(A), would exceed the percentage workload adjust-
`ment (as so determined) for fiscal year 2012, if both
`such adjustment percentages were calculated using the
`5-year base period consisting of fiscal years 2003
`through 2007.
`‘‘(C) LIMITATION.—Under no circumstances shall the
`adjustment under subparagraph (B) result in fee revenues
`for fiscal year 2013 that are less than the sum of the
`amount under paragraph (1)(A) and the amount under
`paragraph (1)(B).’’;
`(3) by striking subsection (c) and inserting the following:
`‘‘(c) ADJUSTMENTS.—
`‘‘(1) INFLATION ADJUSTMENT.—For fiscal year 2014 and sub-
`sequent 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 the amount equal
`to the sum of—
`‘‘(A) one;
`‘‘(B) the average annual percent change in the cost,
`per full-time equivalent position of the Food and Drug
`Administration, of all personnel compensation and benefits
`paid with respect to such positions for the first 3 years
`of the preceding 4 fiscal years, multiplied by the proportion
`of personnel compensation and benefits costs to total costs
`of the process for the review of human drug applications
`(as defined in section 735(6)) for the first 3 years of the
`preceding 4 fiscal years, and
`‘‘(C) the average annual percent change that occurred
`in the Consumer Price Index for urban consumers (Wash-
`ington-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 compensa-
`tion and benefits costs to total costs of the process for
`the review of human drug applications (as defined in sec-
`tion 735(6)) for the first 3 years of the preceding 4 fiscal
`years.
`The adjustment made each fiscal year under this paragraph
`shall be added on a compounded basis to the sum of all adjust-
`ments made each fiscal year after fiscal year 2013 under this
`paragraph.
`‘‘(2) WORKLOAD ADJUSTMENT.—For fiscal year 2014 and
`subsequent fiscal years, after the fee revenues established in
`subsection (b) are adjusted for a fiscal year for inflation in
`accordance with paragraph (1), the fee revenues shall be
`adjusted further for such fiscal year to reflect changes in the
`workload of the Secretary for the process for the review of
`human drug applications. With respect to such adjustment:
`‘‘(A) The adjustment shall be determined by the Sec-
`retary based on a weighted average of the change in the
`total number of human drug applications (adjusted for
`
`Exhibit 2007 Page 006
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`S. 3187—7
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`changes in review activities, as described in the notice
`that the Secretary is required to publish in the Federal
`Register under this subparagraph), efficacy supplements,
`and manufacturing supplements submitted to the Sec-
`retary, and the change in the total number of active
`commercial investigational new drug applications (adjusted
`for changes in review activities, as so described) during
`the most recent 12-month period for which data on such
`submissions is available. The Secretary shall publish in
`the Federal Register the fee revenues and fees resulting
`from the adjustment and the supporting methodologies.
`‘‘(B) Under no circumstances shall the adjustment
`result in fee revenues for a fiscal year that are less than
`the sum of the amount under subsection (b)(1)(A) and the
`amount under subsection (b)(1)(B), as adjusted for inflation
`under paragraph (1).
`‘‘(C) The Secretary shall contract with an independent
`accounting or consulting firm to periodically review the
`adequacy of the adjustment and publish the results of
`those reviews. The first review shall be conducted and
`published by the end of fiscal year 2013 (to examine the
`performance of the adjustment since fiscal year 2009), and
`the second review shall be conducted and published by
`the end of fiscal year 2015 (to examine the continued
`performance of the adjustment). The reports shall evaluate
`whether the adjustment reasonably represents actual
`changes in workload volume and complexity and present
`options to discontinue, retain, or modify any elements of
`the adjustment. The reports shall be published for public
`comment. After review of the reports and receipt of public
`comments, the Secretary shall, if warranted, adopt appro-
`priate changes to the methodology. If the Secretary adopts
`changes to the methodology based on the first report, the
`changes shall be effective for the first fiscal year for which
`fees are set after the Secretary adopts such changes and
`each subsequent fiscal year.
`‘‘(3) FINAL YEAR ADJUSTMENT.—For fiscal year 2017, the
`Secretary may, in addition to adjustments under this paragraph
`and paragraphs (1) and (2), 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 the process for the review
`of human drug applications for the first 3 months of 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 process in
`excess of 3 months of such operating reserves, the adjustment
`under this paragraph shall not be made.
`‘‘(4) ANNUAL FEE SETTING.—The Secretary shall, not later
`than 60 days before the start of each fiscal year that begins
`after September 30, 2012, establish, for the next fiscal year,
`application, product, and establishment fees under subsection
`(a), based on the revenue amounts established under subsection
`(b) and the adjustments provided under this subsection.
`‘‘(5) LIMIT.—The total amount of fees charged, as adjusted
`under this subsection, for a fiscal year may not exceed the
`
`Exhibit 2007 Page 007
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`S. 3187—8
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`total costs for such fiscal year for the resources allocated for
`the process for the review of human drug applications.’’; and
`(4) in subsection (g)—
`(A) in paragraph (1), by striking ‘‘Fees authorized’’
`and inserting ‘‘Subject to paragraph (2)(C), fees authorized’’;
`(B) in paragraph (2)—
`(i) in subparagraph (A)(i), by striking ‘‘shall be
`retained’’ and inserting ‘‘subject to subparagraph (C),
`shall be collected and available’’;
`(ii) in subparagraph (A)(ii), by striking ‘‘shall only
`be collected and available’’ and inserting ‘‘shall be
`available’’; and
`(iii) by adding at the end the following new
`subparagraph:
`‘‘(C) PROVISION FOR EARLY PAYMENTS.—Payment of fees
`authorized under this section for a fiscal year, prior to
`the due date for such fees, may be accepted by the Secretary
`in accordance with authority provided in advance in a
`prior year appropriations Act.’’;
`(C) in paragraph (3), by striking ‘‘fiscal years 2008
`through 2012’’ and inserting ‘‘fiscal years 2013 through
`2017’’; and
`(D) in paragraph (4)—
`(i) by striking ‘‘fiscal years 2008 through 2010’’
`and inserting ‘‘fiscal years 2013 through 2015’’;
`(ii) by striking ‘‘fiscal year 2011’’ and inserting
`‘‘fiscal year 2016’’;
`(iii) by striking ‘‘fiscal years 2008 through 2011’’
`and inserting ‘‘fiscal years 2013 through 2016’’; and
`(iv) by striking ‘‘fiscal year 2012’’ and inserting
`‘‘fiscal year 2017’’.
`SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
`Section 736B (21 U.S.C. 379h–2) is amended—
`(1) by amending subsection (a) to read as follows:
`‘‘(a) PERFORMANCE REPORT.—
`‘‘(1) IN GENERAL.—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 con-
`cerning—
`‘‘(A) the progress of the Food and Drug Administration
`in achieving the goals identified in the letters described
`in section 101(b) of the Prescription Drug User Fee Amend-
`ments of 2012 during such fiscal year and the future plans
`of the Food and Drug Administration for meeting the goals,
`including the status of the
`independent assessment
`described in such letters; and
`‘‘(B) the progress of the Center for Drug Evaluation
`and Research and the Center for Biologics Evaluation and
`Research in achieving the goals, and future plans for
`meeting the goals, including, for each review division—
`‘‘(i) the number of original standard new drug
`applications and biologics license applications filed per
`fiscal year for each review division;
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`S. 3187—9
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`‘‘(ii) the number of original priority new drug
`applications and biologics license applications filed per
`fiscal year for each review division;
`‘‘(iii) the number of standard efficacy supplements
`filed per fiscal year for each review division;
`‘‘(iv) the number of priority efficacy supplements
`filed per fiscal year for each review division;
`‘‘(v) the number of applications filed for review
`under accelerated approval per fiscal year for each
`review division;
`‘‘(vi) the number of applications filed for review
`as fast track products per fiscal year for each review
`division;
`‘‘(vii) the number of applications filed for orphan-
`designated products per fiscal year for each review
`division; and
`‘‘(viii) the number of breakthrough designations
`for a fiscal year for each review division.
`‘‘(2) INCLUSION.—The report under this subsection for a
`fiscal year shall include information on all previous cohorts
`for which the Secretary has not given a complete response
`on all human drug applications and supplements in the cohort.’’.
`(2) in subsection (b), by striking ‘‘2008’’ and inserting
`‘‘2013’’; and
`(3) in subsection (d), by striking ‘‘2012’’ each place it
`appears and inserting ‘‘2017’’.
`SEC. 105. SUNSET DATES.
`(a) AUTHORIZATION.—Sections 735 and 736 of the Federal Food,
`Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to
`be effective October 1, 2017.
`(b) REPORTING REQUIREMENTS.—Section 736B of the Federal
`Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) shall cease to
`be effective January 31, 2018.
`(c) PREVIOUS SUNSET PROVISION.—
`(1) IN GENERAL.—Section 106 of the Food and Drug
`Administration Amendments Act of 2007 (Public Law 110–
`85) is repealed.
`(2) CONFORMING AMENDMENT.—The Food and Drug
`Administration Amendments Act of 2007 (Public Law 110–
`85) is amended in the table of contents in section 2, by striking
`the item relating to section 106.
`(d) TECHNICAL CLARIFICATIONS.—
`(1) Effective September 30, 2007—
`(A) section 509 of the Prescription Drug User Fee
`Amendments Act of 2002 (Title V of Public Law 107–
`188) is repealed; and
`(B) the Public Health Security and Bioterrorism
`Preparedness and Response Act of 2002 (Public Law 107–
`188) is amended in the table of contents in section 1(b),
`by striking the item relating to section 509.
`(2) Effective September 30, 2002—
`(A) section 107 of the Food and Drug Administration
`Modernization Act of 1997 (Public Law 105–115) is
`repealed; and
`(B) the table of contents in section 1(c) of such Act
`is amended by striking the item related to section 107.
`
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`S. 3187—10
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`(3) Effective September 30, 1997, section 105 of the
`Prescription Drug User Fee Act of 1992 (Public Law 102–
`571) is repealed.
`SEC. 106. EFFECTIVE DATE.
`The amendments made by this title shall take effect on October
`1, 2012, or the date of the enactment of this Act, whichever is
`later, except that fees under part 2 of subchapter C of chapter
`VII of the Federal Food, Drug, and Cosmetic Act shall be assessed
`for all human drug applications received on or after October 1,
`2012, regardless of the date of the enactment of this Act.
`SEC. 107. SAVINGS CLAUSE.
`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 enact-
`ment 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 on or after October 1, 2007, but before October
`1, 2012, were accepted by the Food and Drug Administration for
`filing with respect to assessing and collecting any fee required
`by such part for a fiscal year prior to fiscal year 2012.
`TITLE II—FEES RELATING TO DEVICES
`
`SEC. 201. SHORT TITLE; FINDINGS.
`(a) SHORT TITLE.—This title may be cited as the ‘‘Medical
`Device User Fee Amendments of 2012’’.
`(b) FINDINGS.—The Congress finds that the fees authorized
`under the amendments made by this title will be dedicated toward
`expediting the process for the review of device applications and
`for assuring the safety and effectiveness of devices, as set forth
`in the goals identified for purposes of part 3 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. DEFINITIONS.
`Section 737 (21 U.S.C. 379i) is amended—
`(1) in paragraph (9), by striking ‘‘incurred’’ after ‘‘expenses’’;
`(2) in paragraph (10), by striking ‘‘October 2001’’ and
`inserting ‘‘October 2011’’; and
`(3) in paragraph (13), by striking ‘‘is required to register’’
`and all that follows through the end of paragraph (13) and
`inserting the following: ‘‘is registered (or is required to register)
`with the Secretary under section 510 because such establish-
`ment is engaged in the manufacture, preparation, propagation,
`compounding, or processing of a device.’’.
`SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.
`(a) TYPES OF FEES.—Section 738(a) (21 U.S.C. 379j(a)) is
`amended—
`(1) in paragraph (1), by striking ‘‘fiscal year 2008’’ and
`inserting ‘‘fiscal year 2013’’;
`
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`S. 3187—11
`
`(2) in paragraph (2)(A)—
`(A) in the matter preceding clause (i)—
`(i) by striking
`‘‘subsections (d) and (e)’’ and
`inserting ‘‘subsections (d), (e), and (f)’’;
`(ii) by striking ‘‘October 1, 2002’’ and inserting
`‘‘October 1, 2012’’; and
`(iii) by striking ‘‘subsection (c)(1)’’ and inserting
`‘‘subsection (c)’’; and
`(B) in clause (viii), by striking ‘‘1.84’’ and inserting
`‘‘2’’; and
`(3) in paragraph (3)—
`(A) in subparagraph (A), by inserting ‘‘and subsection
`(f)’’ after ‘‘subparagraph (B)’’; and
`(B) in subparagraph (C), by striking ‘‘initial registra-
`tion’’ and all that follows through ‘‘section 510.’’ and
`inserting ‘‘later of—
`‘‘(i) the initial or annual registration (as applicable)
`of the establishment under section 510; or
`‘‘(ii) the first business day after the date of enact-
`ment of an appropriations Act providing for the collec-
`tion and obligation of fees for such year under this
`section.’’.
`(b) FEE AMOUNTS.—Section 738(b) (21 U.S.C. 379j(b)) is
`amended to read as follows:
`‘‘(b) FEE AMOUNTS.—
`‘‘(1) IN GENERAL.—Subject to subsections (c), (d), (e), (f),
`and (i), for each of fiscal years 2013 through 2017, fees under
`subsection (a) shall be derived from the base fee amounts
`specified in paragraph (2), to generate the total revenue
`amounts specified in paragraph (3).
`‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For purposes of para-
`graph (1), the base fee amounts specified in this paragraph
`are as follows:
`
`‘‘Fee Type
`
`Fiscal
`Year
`2013
`
`Fiscal
`Year
`2014
`
`Fiscal
`Year
`2015
`
`Fiscal
`Year
`2016
`
`Fiscal
`Year
`2017
`
`Premarket Application ....
`Establishment Registra-
`tion ................................
`
`$248,000 $252,960 $258,019 $263,180 $268,443
`
`$2,575
`
`$3,200
`
`$3,750
`
`$3,872
`
`$3,872
`
`‘‘(3) TOTAL REVENUE AMOUNTS SPECIFIED.—For purposes
`of paragraph (1), the total revenue amounts specified in this
`paragraph are as follows:
`‘‘(A) $97,722,301 for fiscal year 2013.
`‘‘(B) $112,580,497 for fiscal year 2014.
`‘‘(C) $125,767,107 for fiscal year 2015.
`‘‘(D) $129,339,949 for fiscal year 2016.
`‘‘(E) $130,184,348 for fiscal year 2017.’’.
`(c) ANNUAL FEE SETTING; ADJUSTMENTS.—Section 738(c) (21
`U.S.C. 379j(c)) is amended—
`(1) in the subsection heading, by inserting ‘‘; ADJUSTMENTS’’
`after ‘‘SETTING’’;
`(2) by striking paragraphs (1) and (2);
`(3) by redesignating paragraphs (3) and (4) as paragraphs
`(4) and (5), respectively; and
`
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`

`S. 3187—12
`
`(4) by inserting before paragraph (4), as so redesignated,
`the following:
`‘‘(1) IN GENERAL.—The Secretary shall, 60 days before the
`start of each fiscal year after September 30, 2012, establish
`fees under subsection (a), based on amounts specified under
`subsection (b) and the adjustments provided under this sub-
`section, and publish such fees, and the rationale for any adjust-
`ments to such fees, in the Federal Register.
`‘‘(2) INFLATION ADJUSTMENTS.—
`‘‘(A) ADJUSTMENT TO TOTAL REVENUE AMOUNTS.—For
`fiscal year 2014 and each subsequent fiscal year, the Sec-
`retary shall adjust the total revenue amount specified in
`subsection (b)(3) for such fiscal year by multiplying such
`amount by the applicable inflation adjustment under
`subparagraph (B) for such year.
`‘‘(B) APPLICABLE INFLATION ADJUSTMENT TO TOTAL REV-
`ENUE AMOUNTS.—The applicable inflation adjustment for
`a fiscal year is—
`‘‘(i) for fiscal year 2014, the base inflation adjust-
`ment under subparagraph (C) for such fiscal year; and
`‘‘(ii) for fiscal year 2015 and each subsequent fiscal
`year, the product of—
`inflation adjustment under
`‘‘(I) the base
`subparagraph (C) for such fiscal year; and
`‘‘(II) the product of the base inflation adjust-
`ment under subparagraph (C) for each of the fiscal
`years preceding such fiscal year, beginning with
`fiscal year 2014.
`‘‘(C) BASE INFLATION ADJUSTMENT TO TOTAL REVENUE
`AMOUNTS.—
`‘‘(i) IN GENERAL.—Subject to further adjustment
`under clause (ii), the base inflation adjustment for
`a fiscal year is the sum of one plus—
`‘‘(I) the average annual percent change in the
`cost, per full-time equivalent position of the Food
`and Drug Administration, of all personnel com-
`pensation and benefits paid with respect to such
`positions for the first 3 years of the preceding
`4 fiscal years, multiplied by 0.60; and
`‘‘(II) the average annual percent change that
`occurred in the Consumer Price Index for urban
`consumers (Washington-Baltimore, DC–MD–VA–
`WV; Not