		II
		Calendar No. 420
		112th CONGRESS
		2d Session
		H. R. 5651
		IN THE SENATE OF THE UNITED
		  STATES

			June 4, 2012
			 Received; read twice and placed on the
			 calendar

		AN ACT
		To amend the Federal Food, Drug, and
		  Cosmetic Act to revise and extend the user-fee programs for prescription drugs
		  and for medical devices, to establish user-fee programs for generic drugs and
		  biosimilars, and for other purposes.

		1.Short titleThis Act may be cited as the
			 Food and Drug Administration Reform
			 Act of 2012.
		2.Table of
			 contentsThe table of contents
			 of this Act is as follows:

				Sec. 1. Short title.
				Sec. 2. Table of contents.
				Sec. 3. 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—Medical Device User Fee Amendments of 2012
				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 generic drugs.
				Title IV—Fees relating to biosimilar biological
				products
				Sec. 401. Short title; finding.
				Sec. 402. Fees relating to biosimilar biological
				products.
				Sec. 403. Reauthorization; reporting requirements.
				Sec. 404. Sunset dates.
				Sec. 405. Effective date.
				Sec. 406. Savings clause.
				Sec. 407. Conforming amendment.
				Title V—Reauthorization of Best Pharmaceuticals for Children Act
				and Pediatric Research Equity Act
				Sec. 501. Permanent extension of Best Pharmaceuticals for
				Children Act and Pediatric Research Equity Act.
				Sec. 502. Food and Drug Administration Report.
				Sec. 503. Internal Committee for Review of Pediatric Plans,
				Assessments, Deferrals, Deferral Extensions, and Waivers.
				Sec. 504. Staff of Office of Pediatric
				Therapeutics.
				Sec. 505. Continuation of operation of Pediatric Advisory
				Committee.
				Sec. 506. Pediatric Subcommittee of the Oncologic Drugs
				Advisory Committee.
				Title VI—Food and Drug Administration administrative
				reforms
				Sec. 601. Public participation in issuance of FDA guidance
				documentsHR3204.
				Sec. 602. Conflicts of interest.
				Sec. 603. Electronic submission of applications.
				Sec. 604. Notification of FDA intent to regulate
				laboratory-developed tests.
				Title VII—Medical device regulatory improvements
				Subtitle A—Premarket predictability
				Sec. 701. Investigational device exemptions.
				Sec. 702. Clarification of least burdensome
				standard.
				Sec. 703. Agency documentation and review of significant
				decisionsH.R. 3209.
				Sec. 704. Transparency in clearance processH.R. 3209.
				Sec. 705. Device Modifications Requiring Premarket Notification
				Prior to Marketing.
				Subtitle B—Patients Come First
				Sec. 711. Establishment of schedule and promulgation of
				regulationH.R. 3208.
				Sec. 712. Program to improve the device recall
				systemH.R. 3208.
				Subtitle C—Novel device regulatory relief
				Sec. 721. Modification of de novo application
				processH.R. 3203.
				Subtitle D—Keeping America competitive through
				harmonization
				Sec. 731. Harmonization of device premarket review, inspection,
				and labeling symbols; reportH.R.
				3230.
				Sec. 732. Participation in international fora.
				Subtitle E—FDA renewing efficiency from outside reviewer
				management
				Sec. 741. Reauthorization of Third Party Review.
				Sec. 742. Reauthorization of third party
				inspection.
				Subtitle F—Humanitarian device reform
				Sec. 751. Expanded access to humanitarian use
				devices.
				Subtitle G—Records and Reports on Devices
				Sec. 761. Unique device identification system
				regulations.
				Sec. 762. Effective device sentinel program.
				Subtitle H—Miscellaneous
				Sec. 771. Custom devices.
				Sec. 772. Pediatric device reauthorization.
				Sec. 773. Report on regulation of health information
				technology.
				Title VIII—Drug regulatory improvements
				Subtitle A—Drug supply chain
				Sec. 801. Registration of producers of drugs.
				Sec. 802. Inspection of drugs.
				Sec. 803. Drug supply quality and safety.
				Sec. 804. Prohibition against delaying, denying, limiting, or
				refusing inspection.
				Sec. 805. Destruction of adulterated, misbranded, or
				counterfeit drugs offered for import.
				Sec. 806. Administrative detention.
				Sec. 807. Enhanced criminal penalty for counterfeit
				drugs.
				Sec. 808. Unique facility identification number.
				Sec. 809. Documentation for admissibility of
				imports.
				Sec. 810. Registration of commercial importers.
				Sec. 811. Notification.
				Sec. 812. Exchange of information.
				Sec. 813. Extraterritorial jurisdiction.
				Sec. 814. Protection against intentional
				adulteration.
				Sec. 815. Records for inspection.
				Subtitle B—Medical Gas Safety
				Sec. 821. Regulation of medical gases.
				Sec. 822. Changes to regulations.
				Sec. 823. Rules of construction.
				Subtitle C—Generating Antibiotic Incentives Now
				Sec. 831. Extension of exclusivity period for
				drugs.
				Sec. 832. Study on incentives for qualified infectious disease
				biological products.
				Sec. 833. Clinical trials.
				Sec. 834. Reassessment of qualified infectious disease product
				incentives in 5 years.
				Sec. 835. Guidance on pathogen-focused antibacterial drug
				development.
				Subtitle D—Accelerated approval
				Sec. 841. Expedited approval of drugs for serious or
				life-threatening diseases or conditions.
				Sec. 842. Guidance; amended regulations.
				Sec. 843. Independent review.
				Subtitle E—Critical path reauthorization
				Sec. 851. Reauthorization of the critical path public-private
				partnerships.
				Subtitle F—Miscellaneous
				Sec. 861. Reauthorization of provision relating to exclusivity
				of certain drugs containing single enantiomers.
				Sec. 862. Extension of period for first applicant To obtain
				tentative approval without forfeiting 180-day exclusivity period.
				Sec. 863. Final agency action relating to petitions and civil
				actions.
				Sec. 864. Deadline for determination on certain
				petitions.
				Sec. 865. Rare pediatric disease priority review voucher
				incentive program.
				Sec. 866. Combating prescription drug abuse.
				Sec. 867. Assessment and modification of REMS.
				Sec. 868. Consultation with external experts on rare diseases,
				targeted therapies, and genetic targeting of treatments.
				Sec. 869. Breakthrough therapies.
				Sec. 870. Grants and Contracts for the Development of Orphan
				Drugs.
				Title IX—Drug shortages
				Sec. 901. Discontinuance and interruptions of manufacturing of
				certain drugs.
				Sec. 902. Drug shortage list.
				Sec. 903. Quotas applicable to drugs in shortage.
				Sec. 904. Expedited review of major manufacturing changes for
				potential and verified shortages of drugs that are life-supporting,
				life-sustaining, or intended for use in the prevention of a debilitating
				disease or condition.
				Sec. 905. Study on drug shortages.
				Sec. 906. Annual report on drug shortages.
				Sec. 907. Attorney General report on drug
				shortages.
				Sec. 908. Hospital repackaging of drugs in
				shortage.

		3.References in
			 ActExcept as otherwise
			 specified, amendments made by this Act to a section or other provision of law
			 are amendments to such section or other provision of the Federal Food, Drug,
			 and Cosmetic Act (21
			 U.S.C. 301 et seq.).
		IFees
			 relating to drugs
			101.Short title;
			 finding
				(a)Short
			 titleThis title may be cited
			 as the Prescription Drug User Fee
			 Amendments of 2012.
				(b)FindingThe Congress finds that the fees authorized
			 by the amendments made in this title will be dedicated toward expediting 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 Representatives, as set forth in the
			 Congressional Record.
				102.DefinitionsSection 735(7) (21 U.S.C. 379g) is
			 amended by striking expenses incurred in connection with and
			 inserting expenses in connection with.
			103.Authority to
			 assess and use drug feesSection 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 such 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
			 such fiscal year or the first business day after the enactment of an
			 appropriations Act providing for the collection and obligation of fees for each
			 such fiscal year under this section.; and
							(ii)by
			 amending subparagraph (B) to read as follows:

								(B)ExceptionA
				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)(A) 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)(A);
										(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 application
				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 language preceding subparagraph (A), by striking fiscal years 2008
			 through 2012 and inserting fiscal years 2013 through
			 2017; and
						(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 adjustment for fiscal year 2013 (as determined under
				paragraph (3)(A)); and
								(C)the dollar amount
				equal to the workload adjustment 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 adjustmentsFor purposes of paragraph (1),
				the dollar amount of the inflation and workload adjustments for fiscal year
				2013 shall be determined as follows:
								(A)Inflation
				adjustmentThe inflation adjustment 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
				adjustmentSubject to subparagraph (C), the workload adjustment
				for fiscal 2013 shall be—
									(i)$652,709,000 plus
				the amount of the inflation adjustment calculated under subparagraph (A);
				multiplied by
									(ii)the amount (if
				any) by which a percentage workload adjustment for fiscal year 2013, as
				determined using the methodology described in subsection (c)(2)(A), would
				exceed the percentage workload adjustment (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)LimitationUnder 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
				adjustmentFor 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 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 (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 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.
								The
				adjustment made each fiscal year under this paragraph shall be added on a
				compounded basis to the sum of all adjustments made each fiscal year after
				fiscal year 2013 under this paragraph.(2)Workload
				adjustmentFor 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 Secretary based on a weighted average of the change
				in the total number of human drug applications (adjusted for 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 Secretary, 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 appropriate 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
				adjustmentFor 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 subparagraph shall not be
				made.
							(4)Annual fee
				settingThe 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)LimitThe
				total amount of fees charged, as adjusted under this subsection, for a fiscal
				year may not exceed the total costs for such fiscal year for the resources
				allocated for the process for the review of 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
			 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 paymentsPayment 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.
						104.Reauthorization;
			 reporting requirementsSection
			 736B (21 U.S.C.
			 379h–2) is amended—
				(1)by amending
			 subsection (a) to read as follows:

						(a)Performance
				report
							(1)In
				generalBeginning 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—
								(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 Amendments 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;
									(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; and
									(vii)the number of
				applications filed for orphan-designated products per fiscal year for each
				review division.
									(2)InclusionThe
				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.
				105.Sunset
			 dates
				(a)AuthorizationSections 735 and 736 (21 U.S.C. 379g;
			 379h) are repealed October 1, 2017.
				(b)Reporting
			 requirementsSection 736B
			 (21 U.S.C.
			 379h–2) is repealed January 31, 2018.
				(c)Previous sunset
			 provision
					(1)In
			 generalSection 106 of the Prescription Drug User Fee Amendments
			 of 2007 (Title I of
			 Public Law
			 110–85) is repealed.
					(2)Conforming
			 amendmentThe 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.
						(3)Effective
			 September 30, 1997, section 105 of the Prescription Drug User Fee Act of 1992
			 (Public Law
			 102–571) is repealed.
					106.Effective
			 dateThe 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.
			107.Savings
			 clauseNotwithstanding 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 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.
			IIMedical Device
			 User Fee Amendments of 2012
			201.Short title;
			 findings
				(a)Short
			 titleThis Act may be cited as the Medical Device User Fee Amendments of
			 2012.
				(b)FindingsThe
			 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.
				202.DefinitionsSection 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
			 establishment is engaged in the manufacture, preparation, propagation,
			 compounding, or processing of a device..
				203.Authority to
			 assess and use device fees
				(a)Types of
			 feesSection 738(a) (21 U.S.C. 379j(a))
			 is amended—
					(1)in paragraph (1),
			 by striking fiscal year 2008 and inserting fiscal year
			 2013;
					(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 registration 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 enactment of an appropriations Act providing for
				the collection and obligation of fees for such year under this
				section.
								.
						(b)Fee
			 amountsSection 738(b) (21 U.S.C. 379j(b)) is amended to
			 read as follows:

						(b)Fee
				amounts
							(1)In
				generalSubject 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
				specifiedFor purposes of paragraph (1), the base fee amounts
				specified in this paragraph are as follows:

											Fee TypeFiscal Year 2013Fiscal Year 2014Fiscal Year 2015Fiscal Year 2016Fiscal Year 2017

											Premarket Application$248,000$252,960$258,019$263,180$268,443

											Establishment Registration$2,575$3,200$3,750$3,872$3,872

							(3)Total revenue
				amountsFor 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; adjustmentsSection
			 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
					(4)by inserting
			 before paragraph (4), as so redesignated, the following:

							(1)In
				generalThe 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 subsection, and publish such fees, and the rationale for any
				adjustments to such fees, in the Federal Register.
							(2)Inflation
				adjustments
								(A)Adjustment to
				total revenue amountsFor fiscal year 2014 and each subsequent
				fiscal year, the Secretary 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 revenue amountsThe applicable
				inflation adjustment for a fiscal year is—
									(i)for fiscal year
				2014, the base inflation adjustment under
				subparagraph (C) for such fiscal year;
				and
									(ii)for fiscal year
				2015 and each subsequent fiscal year, the product of—
										(I)the base inflation
				adjustment under
				subparagraph (C) for such fiscal year;
				and
										(II)the product of
				the base inflation adjustment 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
				generalSubject 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 compensation 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 Seasonally Adjusted; All
				items; Annual Index) for the first 3 years of the preceding 4 years of
				available data multiplied by 0.40.
										(ii)LimitationsFor
				purposes of
				subparagraph (B), if the base inflation
				adjustment for a fiscal year under clause (i)—
										(I)is less than 1,
				such adjustment shall be considered to be equal to 1; or
										(II)is greater than
				1.04, such adjustment shall be considered to be equal to 1.04.
										(D)Adjustment to
				base fee amountsFor each of
				fiscal years 2014 through 2017, the base fee amounts specified in subsection
				(b)(2) shall be adjusted as needed, on a uniform proportionate basis, to
				generate the total revenue amounts under subsection (b)(3), as adjusted for
				inflation under subparagraph (A).
								(3)Volume-based
				adjustments to establishment registration base feesFor each of
				fiscal years 2014 through 2017, after the base fee amounts specified in
				subsection (b)(2) are adjusted under paragraph (2)(D), the base establishment
				registration fee amounts specified in such subsection shall be further
				adjusted, as the Secretary estimates is necessary in order for total fee
				collections for such fiscal year to generate the total revenue amounts, as
				adjusted under paragraph
				(2).
							.
					(d)Fee waiver or
			 reductionSection 738
			 (21 U.S.C.
			 379j) is amended by—
					(1)redesignating
			 subsections (f) through (k) as subsections (g) through (l), respectively;
			 and
					(2)by inserting after
			 subsection (e) the following new subsection (f):

							(f)Fee waiver or
				reduction
								(1)In
				generalThe Secretary may, at the Secretary’s sole discretion,
				grant a waiver or reduction of fees under subsection (a)(2) or (a)(3) if the
				Secretary finds that such waiver or reduction is in the interest of public
				health.
								(2)LimitationThe
				sum of all fee waivers or reductions granted by the Secretary in any fiscal
				year under paragraph (1) shall not exceed 2 percent of the total fee revenue
				amounts established for such year under subsection (c).
								(3)DurationThe
				authority provided by this subsection terminates October 1,
				2017.
								.
					(e)ConditionsSection 738(h)(1)(A) (21 U.S.C.
			 379j(h)(1)(A)), as redesignated by subsection (d)(1), is
			 amended by striking $205,720,000 and inserting
			 $280,587,000.
				(f)Crediting and
			 availability of feesSection
			 738(i) (21 U.S.C.
			 379j(i)), as redesignated by subsection (d)(1), is
			 amended—
					(1)in paragraph (1),
			 by striking Fees authorized and inserting Subject to
			 paragraph (2)(C), fees authorized;
					(2)in paragraph
			 (2)—
						(A)in subparagraph
			 (A)—
							(i)in
			 clause (i), by striking shall be retained and inserting
			 subject to subparagraph (C), shall be collected and available;
			 and
							(ii)in
			 clause (ii)—
								(I)by striking
			 collected and after shall only be; and
								(II)by striking
			 fiscal year 2002 and inserting fiscal year 2009;
			 and
								(B)by adding at the
			 end, the following:

								(C)Provision for
				early year paymentsPayment of fees authorized under this section
				for a fiscal year, prior to the due date for such fees, may be accepted by the
				Secretary in accordance with authority provided in advance in a prior year
				appropriations
				Act.
								;
						(3)in paragraph (3),
			 by amending to read as follows:

							(3)Authorizations
				of appropriationsFor each of the fiscal years 2013 through 2017,
				there is authorized to be appropriated for fees under this section an amount
				equal to the total revenue amount specified under subsection (b)(3) for the
				fiscal year, as adjusted under subsection (c) and, for fiscal year 2017 only,
				as further adjusted under paragraph
				(4).
							;
				and
					(4)in paragraph
			 (4)—
						(A)by striking
			 fiscal years 2008, 2009, and 2010 and inserting fiscal
			 years 2013, 2014, and 2015;
						(B)by striking
			 fiscal year 2011 and inserting fiscal year
			 2016;
						(C)by striking
			 June 30, 2011 and inserting June 30, 2016;
						(D)by striking
			 the amount of fees specified in aggregate in and inserting
			 the cumulative amount appropriated pursuant to;
						(E)by striking
			 aggregate amount in before excess shall be
			 credited; and
						(F)by striking
			 fiscal year 2012 and inserting fiscal year
			 2017.
						(g)Conforming
			 amendmentSection
			 515(c)(4)(A) (21
			 U.S.C. 360e(c)(4)(A)) is amended by striking
			 738(g) and inserting 738(h).
				204.Reauthorization;
			 reporting requirements
				(a)ReauthorizationSection 738A(b) (21 U.S.C.
			 379j–1(b)) is amended—
					(1)in paragraph (1),
			 by striking 2012 and inserting 2017; and
					(2)in paragraph (5), by striking
			 2012 and inserting 2017.
					(b)Performance
			 reportsSection 738A(a)
			 (21 U.S.C.
			 379j–1(a)) is amended—
					(1)by striking
			 paragraph (1) and inserting the following:

							(1)Performance
				report
								(A)In
				generalBeginning with fiscal year 2013, for each fiscal year for
				which fees are collected under this part, the Secretary shall prepare and
				submit to the Committee on Health, Education, Labor, and Pensions of the Senate
				and the Committee on Energy and Commerce of the House of Representatives annual
				reports concerning the progress of the Food and Drug Administration in
				achieving the goals identified in the letters described in section 201(b) of
				the Medical Device User Fee Amendments of
				2012 during such fiscal year and the future plans of the Food and
				Drug Administration for meeting the goals.
								(B)PublicationWith
				regard to information to be reported by the Food and Drug Administration to
				industry on a quarterly and annual basis pursuant to the letters described in
				section 201(b) of the Medical Device User Fee Amendments Act of 2012, the
				Secretary shall make such information publicly available on the Internet
				Website of the Food and Drug Administration not later than 60 days after the
				end of each quarter or 120 days after the end of each fiscal year,
				respectively, to which such information applies. This information shall include
				the status of the independent assessment identified in the letters described in
				such section 201(b).
								(C)UpdatesThe
				Secretary shall include in each report under subparagraph (A) information on
				all previous cohorts for which the Secretary has not given a complete response
				on all device premarket applications and reports, supplements, and premarket
				notifications in the cohort.
								;
				and
					(2)in paragraph (2), by striking 2008
			 through 2012 and inserting 2013 through 2017.
					205.Savings
			 clauseNotwithstanding the
			 amendments made by this title, part 3 of subchapter C of chapter VII of the
			 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in
			 effect on the day before the date of the enactment of this title, shall
			 continue to be in effect with respect to the submissions listed in section
			 738(a)(2)(A) of such Act (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 2013.
			206.Effective
			 dateThe 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 3 of subchapter C
			 of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed
			 for all submissions listed in section 738(a)(2)(A) of such Act received on or
			 after October 1, 2012, regardless of the date of the enactment of this
			 Act.
			207.Sunset
			 clause
				(a)In
			 generalSections 737 and 738
			 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease
			 to be effective October 1, 2017. Section 738A (21 U.S.C. 739j–1) of the Federal
			 Food, Drug, and Cosmetic Act (regarding reauthorization and reporting
			 requirements) is repealed January 31, 2018.
				(b)Previous sunset
			 provision
					(1)In
			 generalSection 217 of the Medical Device User Fee Amendments of
			 2007 (Title II of
			 Public Law
			 110–85) is repealed.
					(2)Conforming
			 amendmentThe 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
			 217.
					(c)Technical
			 clarificationEffective September 30, 2007—
					(1)section 107 of the
			 Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250) is repealed;
			 and
					(2)the table of
			 contents in section 1(b) of such Act is amended by striking the item related to
			 section 107.
					208.Streamlined
			 hiring authority to support activities related to the process for the review of
			 device applicationsSubchapter
			 A of chapter VII (21
			 U.S.C. 371 et seq.) is amended by inserting after section 713
			 the following new section:

					714.Streamlined
				hiring authority
						(a)In
				generalIn 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
				describedThe activities described in this subsection are
				activities under this Act related to the process for the review of device
				applications (as defined in section 737(8)).
						(c)Objectives
				specifiedThe objectives specified in this subsection are with
				respect to the activities under
				subsection (b)(1), the goals referred
				to in section 738A(a)(1).
						(d)Internal
				controlsThe Secretary shall institute appropriate internal
				controls for appointments under this section.
						(e)SunsetThe
				authority to appoint employees under this section shall terminate on the date
				that is three years after the date of enactment of this
				section.
						.

			IIIFees relating to
			 generic drugs
			301.Short
			 title
				(a)Short
			 titleThis title may be cited
			 as the Generic Drug User Fee
			 Amendments of 2012.
				(b)FindingThe Congress finds that the fees authorized
			 by the amendments made in this title will be dedicated to human generic drug
			 activities, as set forth in the goals identified for purposes of part 7 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.
				302.Authority to
			 assess and use human generic drug feesSubchapter C of chapter VII (21 U.S.C. 379f et
			 seq.) is amended by adding at the end the following:

					7FEES
				RELATING TO GENERIC DRUGS
						744A.DefinitionsFor 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.
							744B.Authority to
				assess and use human generic drug fees
							(a)Types of
				feesBeginning 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
				generalEach 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 calculationThe 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)NoticeNot
				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
				dateThe 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
				generalEach 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
				paymentIf 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
				2013Not 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 2017Not 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
				generalSubject 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)ConditionsA
				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)ListThe Secretary shall make publicly available
				on the 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
				generalSubject to clause (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)LimitationNo 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
				generalEach 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
				2013Not 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 2017Not 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
				generalExcept 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 2013For 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
				receivedThe 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
				withdrawnAn 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 fileAn
				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
				generalFacilities 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
				facilityEach 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 facilityEach 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
				formsEach 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)AmountThe
				amount of fees established under subparagraph (A) shall be established under
				subsection (d).
									(C)Notice
										(i)Fiscal year
				2013For 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 2017Within 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
				2013For 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 2017For 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
				submissionFor 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—
									(A)if it is submitted
				via a Food and Drug Administration electronic gateway, on the day when
				transmission to that electronic gateway is completed, except that a submission
				or master file that arrives on a weekend, Federal holiday, or day when the Food
				and Drug Administration office that will review that submission is not
				otherwise open for business shall be deemed to be submitted on the next day
				when that office is open for business; and
									(B)if it is submitted
				in physical media form, on the day it arrives at the appropriate designated
				document room of the Food and Drug Administration.
									(b)Fee revenue
				amounts
								(1)In
				general
									(A)Fiscal year
				2013For 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 2017For 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
				feesIn establishing fees
				under paragraph (1) to generate the revenue amounts specified in paragraph
				(1)(A)(ii) for fiscal year 2013 and paragraph (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
				adjustmentFor 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
				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 human generic drug activities 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
				(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
				adjustmentFor 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
				2013For 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 2017Not 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 fileIn 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)LimitThe
				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 complianceNot 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 identificationEach 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 the previous year.
									(3)Contents of
				noticeAt 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
				generalAny 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
				organizationsA 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)NoticeThe 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
				authorityThe Secretary’s inspection 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 feeFailure 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 feeFailure 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
				generalFailure 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 section 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
				penaltiesThe 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)NoticeIf
				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)NonreceivalIf
				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 section 505(j)(5)(A).
										(h)Limitations
								(1)In
				generalFees 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)AuthorityIf
				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
				generalFees 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
				generalThe 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 section 744A(3) applicable to the fiscal year
				involved.
										(B)ComplianceThe
				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 yearUntil 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 yearsPayment 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
				appropriationsFor 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 feesIn 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)ConstructionThis
				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
				feesSubmission 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
				requirementFacilities 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 feesTo 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 applicationsAn 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.
							.
			303.Reauthorization;
			 reporting requirementsPart 7
			 of subchapter C of chapter VII, as added by section 302 of this Act, is amended
			 by inserting after section 744B the following:

					744C.Reauthorization;
				reporting requirements
						(a)Performance
				report
							(1)In
				generalBeginning 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 301(b) 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.
							(2)Regulatory
				science accountability metricsThe report required by paragraph (1) shall
				describe the amounts spent, data generated, and activities undertaken,
				including any FDA Advisory Committee consideration, by the Secretary for each
				of the local acting bioequivalence topics (Topics 1–3) in the Regulatory
				Science Plan described in the letters described in section 301(b) of the
				Generic Drug User Fee Amendments of 2012.
							(b)Fiscal
				reportBeginning 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
				availabilityThe 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)ConsultationIn
				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
				inputPrior 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
				consultationNot 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
				recommendationsAfter 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
				recommendationsNot 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
				availabilityBefore presenting the recommendations developed
				under paragraphs (1) through (5) to the Congress, the Secretary shall make
				publicly available, on the Internet Web site of the Food and Drug
				Administration, minutes of all negotiation meetings conducted under this
				subsection between the Food and Drug Administration and the generic drug
				industry.
								(B)ContentThe
				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.
								.
			304.Sunset
			 dates
				(a)AuthorizationSections 744A and 744B, as added by section
			 302 of this Act, are repealed October 1, 2017.
				(b)Reporting
			 requirementsSection 744C, as
			 added by section 303 of this Act, is repealed January 31, 2018.
				305.Effective
			 dateThe 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 302 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.
			306.Amendment with
			 respect to misbrandingSection
			 502 (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.
					.
			307.Streamlined
			 hiring authority to support activities related to human generic
			 drugsSection 714, as added by
			 section 208 of this Act, is amended—
				(1)by amending
			 subsection (b) to read as follows:

						(b)Activities
				describedThe activities described in this subsection are—
							(1)activities under
				this Act related to the process for the review of device applications (as
				defined in section 737(8)); and
							(2)activities under this Act related to human
				generic drug activities (as defined in section
				744A).
							;
				and
				(2)by amending
			 subsection (c) to read as follows:

						(c)Objectives
				specifiedThe objectives specified in this subsection are—
							(1)with respect to
				the activities under
				subsection (b)(1), the goals referred
				to in section 738A(a)(1); and
							(2)with respect to the activities under
				subsection (b)(2), the goals referred
				to in section
				744C(a).
							.
				IVFees
			 relating to biosimilar biological products
			401.Short title;
			 finding
				(a)Short
			 titleThis title may be cited
			 as the Biosimilar User Fee Act of
			 2012.
				(b)FindingThe 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.
				402.Fees relating
			 to biosimilar biological productsSubchapter C of chapter VII (21 U.S.C. 379f et
			 seq.) is amended by inserting after part 7, as added by title
			 III of this Act, the following:

					8FEES
				RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
						744G.DefinitionsFor 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.
							744H.Authority to
				assess and use biosimilar biological product fees
							(a)Types of
				feesBeginning 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
				generalEach 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
				requestThe meeting request defined in this clause is a request
				for a biosimilar biological product development meeting for a product.
										(iii)Clinical
				protocol for INDA 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
				DateThe 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
				ruleEach 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
				generalA 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
				dateThe 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)ExceptionThe
				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 obligationA 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
				generalA 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 feeA 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 meetingsIf 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 applicationsExcept 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
				holdNotwithstanding 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 supplementsIf 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
				refundsThe 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 reductionsThe 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
				generalEach 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 for which
				clinical data (other than comparative bioavailability studies) with respect to
				safety or effectiveness are required for approval; 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
				feesNotwithstanding section 404 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
				dateAny 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 supplementIf 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
				filingThe 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
				filingA 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
				generalExcept as provided in subparagraph (E), 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 yearsThe 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
				dateThe 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 productsIf, 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
				generalEach 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
				dateThe 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 yearThe biosimilar biological product fee shall be
				paid only once for each product for each fiscal year.
									(b)Fee setting and
				amounts
								(1)In
				generalSubject 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 feeThe 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)(4) for a human drug application described in section
				736(a)(1)(A)(i) for that fiscal year.
									(B)Annual
				biosimilar biological product development feeThe 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)(4) for a human drug application described in section
				736(a)(1)(A)(i) for that fiscal year.
									(C)Reactivation
				feeThe 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)(4) for a human drug
				application described in section 736(a)(1)(A)(i) for that fiscal year.
									(D)Biosimilar
				biological product application feeThe biosimilar biological product
				application fee under subsection (a)(2) for a fiscal year shall be equal to the
				amount established under section 736(c)(4) for a human drug application
				described in section 736(a)(1)(A)(i) for that fiscal year.
									(E)Biosimilar
				biological product establishment feeThe biosimilar biological
				product establishment fee under subsection (a)(3) for a fiscal year shall be
				equal to the amount established under section 736(c)(4) for a prescription drug
				establishment for that fiscal year.
									(F)Biosimilar
				biological product feeThe biosimilar biological product fee
				under subsection (a)(4) for a fiscal year shall be equal to the amount
				established under section 736(c)(4) for a prescription drug product for that
				fiscal year.
									(2)LimitThe
				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 feeThe 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)ConsiderationsIn
				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
				definedIn 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 feesA 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
				generalSubject 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
				generalSubject 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
				limitationThe 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 yearUntil 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 yearsPayment 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
				appropriationsFor 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 feesIn 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 refundsTo 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)ConstructionThis
				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.
							.
			403.Reauthorization;
			 reporting requirementsPart 8
			 of subchapter C of chapter VII, as added by section 402 of this Act, is further
			 amended by inserting after section 744H the following:

					744I.Reauthorization;
				reporting requirements
						(a)Performance
				reportBeginning 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 401(b) of the Biosimilar 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
				reportNot 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
				availabilityThe 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
				generalThe 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
				resultsNot later than June 1, 2015, the Secretary shall publish,
				for public comment, interim results of the study described under paragraph
				(1).
							(3)Final
				resultsNot 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)ConsultationIn 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
				recommendationsAfter 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
				recommendationsNot 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.
							.
			404.Sunset
			 dates
				(a)AuthorizationSections 744G and 744H, as added by section
			 402 of this Act, are repealed October 1, 2017.
				(b)Reporting
			 requirementsSection 744I, as
			 added by section 403 of this Act, is repealed January 31, 2018.
				405.Effective
			 date
				(a)In
			 generalExcept 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)ExceptionFees
			 under part 8 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.
				406.Savings
			 clauseNotwithstanding 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.
			407.Conforming
			 amendmentSection 735(1)(B)
			 (21 U.S.C.
			 379g(1)(B)) is amended by striking or
			 (k).
			VReauthorization of
			 Best Pharmaceuticals for Children Act and Pediatric Research Equity
			 Act
			501.Permanent
			 extension of Best Pharmaceuticals for Children Act and Pediatric Research
			 Equity Act
				(a)Program for
			 pediatric studies of drugsSection 409I(c) of the Public Health
			 Service Act (42
			 U.S.C. 284m(c)) is amended—
					(1)in subsection
			 (c)(1)—
						(A)in the matter
			 preceding subparagraph (A), by inserting or section 351(m) of this
			 Act, after Cosmetic Act,;
						(B)in subparagraph
			 (A)(i), by inserting or section 351(k) of this Act after
			 Cosmetic Act; and
						(C)by amending
			 subparagraph (B) to read as follows:

								(B)(i)there remains no patent
				listed pursuant to section 505(b)(1) of the Federal Food, Drug, and Cosmetic
				Act; and
									(ii)every three-year and five-year period
				referred to in subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E(iv),
				(j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of the Federal
				Food, Drug and Cosmetic Act, or applicable twelve-year period referred to in
				section 351(k)(7) of this Act, and any seven-year period referred to in section
				527 of the Federal Food, Drug, and Cosmetic Act, has ended for at least one
				form of the drug;
				and
									;
						(2)in subsection
			 (c)(2)—
						(A)in the heading of
			 paragraph (2), by striking for drugs lacking exclusivity;
						(B)by striking
			 under section 505 of the Federal Food, Drug, and Cosmetic Act;
			 and
						(C)by striking
			 505A of such Act and inserting 505A of the Federal Food,
			 Drug, and Cosmetic Act or section 351(m) of this Act; and
						(3)in subsection (e)(1), by striking to
			 carry out this section and all that follows through the end of
			 paragraph (1) and inserting $25,000,000 for each of fiscal years 2013
			 through 2017..
					(b)Pediatric
			 studies of drugs in FFDCASection 505A (21 U.S.C. 355a) is
			 amended—
					(1)in subsection
			 (d)(1)(A), by adding at the end the following: If a request under this
			 subparagraph does not request studies in neonates, such request shall include a
			 statement describing the rationale for not requesting studies in
			 neonates.;
					(2)by amending
			 subsection (h) to read as follows:

							(h)Relationship to
				pediatric research requirementsExclusivity under this section shall only
				be granted for the completion of a study or studies that are the subject of a
				written request and for which reports are submitted and accepted in accordance
				with subsection (d)(3). Written requests under this section may consist of a
				study or studies required under section
				505B.
							;
					(3)in subsection
			 (k)(2), by striking subsection (f)(3)(F) and inserting
			 subsection (f)(6)(F);
					(4)in subsection
			 (l)—
						(A)in paragraph
			 (1)—
							(i)in the paragraph
			 heading, by striking year
			 one and inserting first 18-month period;
			 and
							(ii)by striking
			 one-year and inserting 18-month;
							(B)in paragraph
			 (2)—
							(i)in the paragraph
			 heading, by striking years and inserting periods; and
							(ii)by striking
			 one-year period and inserting 18-month
			 period;
							(C)by redesignating
			 paragraph (3) as paragraph (4); and
						(D)by inserting after
			 paragraph (2) the following:

								(3)Preservation of
				authorityNothing in this
				subsection shall prohibit the Office of Pediatric Therapeutics from providing
				for the review of adverse event reports by the Pediatric Advisory Committee
				prior to the 18-month period referred to in paragraph (1), if such review is
				necessary to ensure safe use of a drug in a pediatric
				population.
								;
						(5)in subsection
			 (n)—
						(A)in the subsection
			 heading, by striking Completed and inserting
			 Submitted; and
						(B)in paragraph
			 (1)—
							(i)in the text
			 preceding subparagraph (A), by striking have not been completed
			 and inserting have not been submitted by the date specified in the
			 written request issued and agreed upon; and
							(ii)by revising
			 subparagraphs (A) and (B) to read as follows:

									(A)For a drug for which there remains any
				listed patent or exclusivity protection eligible for extension under subsection
				(b)(1) or (c)(1) of this section, or any exclusivity protection eligible for
				extension under subsection (m)(2) or (m)(3) of section 351 of the Public Health
				Service Act, the Secretary shall make a determination regarding whether an
				assessment shall be required to be submitted under section 505B(b).
									(B)For a drug that has no remaining listed
				patents or exclusivity protection eligible for extension under subsection
				(b)(1) or (c)(1) of this section, or any exclusivity protection eligible for
				extension under subsection (m)(2) or (m)(3) of section 351 of the Public Health
				Service Act, the Secretary shall refer the drug for inclusion on the list
				established under section 409I of the Public Health Service Act for the conduct
				of
				studies.
									;
							(6)in subsection
			 (o)(2), by amending subparagraph (B) to read as follows:

							(B)a statement of any appropriate pediatric
				contraindications, warnings, precautions, or other information that the
				Secretary considers necessary to assure safe
				use.
							;
				and
					(7)by striking
			 subsection (q) (relating to a sunset).
					(c)Research into
			 pediatric uses for drugs and biological projects in FFDCASection 505B (21 U.S.C. 355c) is
			 amended—
					(1)in subsection
			 (a)—
						(A)in paragraph (1),
			 in the matter before subparagraph (A), by inserting for a drug
			 after (or supplement to an application);
						(B)in paragraph
			 (3)—
							(i)by redesignating
			 subparagraph (B) as subparagraph (D); and
							(ii)by inserting
			 after subparagraph (A) the following:

									(B)Deferral
				extensionOn the initiative
				of the Secretary or at the request of the applicant, the Secretary may grant an
				extension of a deferral under subparagraph (A) if—
										(i)the Secretary
				finds that the criteria specified in subclause (II) or (III) of subparagraph
				(A)(i) continue to be met; and
										(ii)the applicant
				submits the materials required under subparagraph (A)(ii).
										(C)Consideration
				during deferral periodIf the
				Secretary has under this paragraph deferred the date by which an assessment
				must be submitted, then until the date specified in the deferral under
				subparagraph (A) (including any extension of such date under subparagraph
				(B))—
										(i)the assessment
				shall not be considered late or delayed; and
										(ii)the Secretary
				shall not classify the assessment as late or delayed in any report, database,
				or public posting.
										;
				and
							(iii)in subparagraph
			 (D), as redesignated, by amending clause (ii) to read as follows:

									(ii)Public
				availabilityNot later than
				60 days after the submission to the Secretary of the information submitted
				through the annual review under clause (i), the Secretary shall make available
				to the public in an easily accessible manner, including through the Web site of
				the Food and Drug Administration—
										(I)such
				information;
										(II)the name of the
				applicant for the product subject to the assessment;
										(III)the date on
				which the product was approved; and
										(IV)the date of each
				deferral or deferral extension under this paragraph for the
				product.
										;
				and
							(C)in paragraph
			 (4)(C)—
							(i)in the first
			 sentence, by inserting partial before waiver is
			 granted; and
							(ii)in the second
			 sentence, by striking either a full or partial waiver and
			 inserting a partial waiver;
							(2)in subsection (b)(1), by striking
			 After providing notice in the form of a letter (that, for a drug
			 approved under section 505, references a declined written request under section
			 505A for a labeled indication which written request is not referred under
			 section 505A(n)(1)(A) to the Foundation of the National Institutes of Health
			 for the pediatric studies), the Secretary and inserting The
			 Secretary;
					(3)by amending
			 subsection (d) to read as follows:

							(d)Failure To meet
				requirementsIf a person
				fails to submit a required assessment described in subsection (a)(2), fails to
				meet the applicable requirements in subsection (a)(3), or fails to submit a
				request for approval of a pediatric formulation described in subsection (a) or
				(b), in accordance with applicable provisions of subsections (a) and
				(b)—
								(1)(A)the Secretary shall
				issue a letter to such person informing such person of such failure;
									(B)not later than 30 calendar days after
				the issuance of a letter under
				subparagraph (A), the person who
				receives such letter shall submit to the Secretary a written response to such
				letter; and
									(C)not later than 45 calendar days after
				the issuance of a letter under
				subparagraph (A), the Secretary shall
				make such letter, and any response to such letter under
				subparagraph (B), available to the
				public on the Web site of the Food and Drug Administration, with appropriate
				redactions made to protect trade secrets and confidential commercial
				information, except that, if the Secretary determines that the letter under
				subparagraph (A) was issued in error, the requirements of this subparagraph
				shall not apply with respect to such letter; and
									(2)(A)the drug or biological
				product that is the subject of the required assessment, applicable requirements
				in subsection (a)(3), or required request for approval of a pediatric
				formulation may be considered misbranded solely because of that failure and
				subject to relevant enforcement action (except that the drug or biological
				product shall not be subject to action under section 303); but
									(B)the failure to submit the required
				assessment, meet the applicable requirements in subsection (a)(3), or submit
				the required request for approval of a pediatric formulation shall not be the
				basis for a proceeding—
										(i)to withdraw approval for a drug
				under section 505(e); or
										(ii)to revoke the license for a
				biological product under section 351 of the Public Health Service
				Act.
										;
					(4)by amending
			 subsection (e) to read as follows:

							(e)Initial
				pediatric plan
								(1)In
				general
									(A)SubmissionAn applicant who is required to submit an
				assessment under subsection (a)(1) shall submit an initial pediatric
				plan.
									(B)TimingAn
				applicant shall submit the initial pediatric plan under
				paragraph (1)—
										(i)before the date on
				which the applicant submits the assessments under subsection (a)(2); and
										(ii)not later
				than—
											(I)60 calendar days after the date of
				end-of-Phase 2 meeting (as such term is used in
				section
				312.47 of title 21, Code of Federal Regulations, or successor
				regulations); or
											(II)such other time
				as may be agreed upon between the Secretary and the applicant.
											Nothing in this section shall
				preclude the Secretary from accepting the submission of an initial pediatric
				plan earlier than the date otherwise applicable under this subparagraph.(C)ContentsThe
				initial pediatric plan shall include—
										(i)an outline of the
				pediatric studies that the applicant plans to conduct;
										(ii)any request for a
				deferral, partial waiver, or waiver under this section, along with supporting
				information; and
										(iii)other
				information the Secretary determines necessary, including any information
				specified in regulations under paragraph (5).
										(2)Meeting
									(A)In
				generalSubject to
				subparagraph (B), not later than 90
				calendar days after receiving an initial pediatric plan under
				paragraph (1), the Secretary shall meet
				with the applicant to discuss the plan.
									(B)Written
				responseIf the Secretary determines that a written response to
				the initial pediatric plan is sufficient to communicate comments on the initial
				pediatric plan, and that no meeting is necessary the Secretary shall, not later
				than 90 days after receiving an initial pediatric plan under
				paragraph (1)—
										(i)notify the
				applicant of such determination; and
										(ii)provide to the
				applicant the Secretary’s written comments on the plan.
										(3)Agreed initial
				pediatric plan
									(A)SubmissionThe
				applicant shall submit to the Secretary a document reflecting the agreement
				between the Secretary and the applicant on the initial pediatric plan (referred
				to in this subsection as an agreed initial pediatric
				plan).
									(B)ConfirmationNot
				later than 30 days after receiving the agreed initial pediatric plan under
				subparagraph (A), the Secretary shall
				provide written confirmation to the applicant that such plan reflects the
				agreement of the Secretary.
									(C)Deferral and
				waiverIf the agreed initial
				pediatric plan contains a request from the applicant for a deferral, partial
				waiver, or waiver under this section, the written confirmation under
				subparagraph (B) shall include a
				recommendation from the Secretary as to whether such request meets the
				standards under paragraphs (3) or (4) of subsection (a).
									(D)Amendments to
				the planAt the initiative of
				the Secretary or the applicant, the agreed initial pediatric plan may be
				amended at any time. The requirements of paragraph (2) shall apply to any such
				proposed amendment in the same manner and to the same extent as such
				requirements apply to an initial pediatric plan under paragraph (1). The
				requirements of subparagraphs (A) through (C) of this paragraph shall apply to
				any agreement resulting from such proposed amendment in the same manner and to
				the same extent as such requirements apply to an agreed initial pediatric
				plan.
									(4)Internal
				committeeThe Secretary shall
				consult the internal committee under section 505C on the review of the initial
				pediatric plan, greed initial pediatric plan, and any amendments to such
				plans.
								(5)Mandatory
				rulemakingNot later than one
				year after the date of enactment of the Food
				and Drug Administration Reform Act of 2012, the Secretary shall
				promulgate proposed regulations and guidance to implement the provisions of
				this subsection.
								(6)Effective
				dateThe provisions of this
				subsection shall take effect 180 calendar days after the date of enactment of
				the Food and Drug Administration Reform Act
				of 2012, irrespective of whether the Secretary has promulgated
				final regulations to carry out this subsection by such
				date.
								;
					(5)in subsection
			 (f)—
						(A)in the subsection heading, by inserting
			 Deferral
			 Extensions, after Deferrals,;
						(B)in paragraph
			 (4)—
							(i)in the paragraph
			 heading, by inserting deferral extensions, after
			 deferrals,; and
							(ii)in the second
			 sentence, by inserting , deferral extensions, after
			 deferrals; and
							(C)in paragraph
			 (6)(D)—
							(i)by inserting
			 and deferral extensions before requested and
			 granted; and
							(ii)by inserting
			 and deferral extensions after the reasons for such
			 deferrals;
							(6)in subsection
			 (g)—
						(A)in paragraph
			 (1)(A), by striking after the date of the submission of the application
			 or supplement and inserting after the date of the submission of
			 an application or supplement that receives a priority review or 330 days after
			 the date of the submission of an application or supplement that receives a
			 standard review; and
						(B)in paragraph (2),
			 by striking the label of such product and inserting the
			 labeling of such product;
						(7)in subsection
			 (h)(1)—
						(A)by inserting
			 an application (or supplement to an application) that contains
			 after date of submission of; and
						(B)by inserting
			 if the application (or supplement) receives a priority review, or not
			 later than 330 days after the date of submission of an application (or
			 supplement to an application) that contains a pediatric assessment under this
			 section, if the application (or supplement) receives a standard review,
			 after under this section,;
						(8)in subsection
			 (i)—
						(A)in paragraph
			 (1)—
							(i)in the paragraph
			 heading, by striking year
			 one and inserting first 18-month period;
			 and
							(ii)by striking
			 one-year and inserting 18-month;
							(B)in paragraph
			 (2)—
							(i)in the paragraph
			 heading, by striking years and inserting periods; and
							(ii)by striking
			 one-year period and inserting 18-month
			 period;
							(C)by redesignating
			 paragraph (3) as paragraph (4); and
						(D)by inserting after
			 paragraph (2) the following:

								(3)Preservation of
				authorityNothing in this
				subsection shall prohibit the Office of Pediatric Therapeutics from providing
				for the review of adverse event reports by the Pediatric Advisory Committee
				prior to the 18-month period referred to in paragraph (1), if such review is
				necessary to ensure safe use of a drug in a pediatric
				population.
								;
						(9)by striking
			 subsection (m) (relating to integration with other pediatric studies);
			 and
					(10)by redesignating
			 subsection (n) as subsection (m).
					(d)Pediatric
			 studies of biological products in PHSASection 351(m)(1) of the
			 Public Health Service Act (42 U.S.C. 262(m)(1)) is amended by
			 striking (f), (i), (j), (k), (l), (p), and (q) and inserting
			 (f), (h), (i), (j), (k), (l), (n), and (p).
				(e)Application;
			 transition rule
					(1)ApplicationNotwithstanding any provision of section
			 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a,
			 355c) stating that a provision applies beginning on the date of the enactment
			 of the Best Pharmaceuticals for Children Act of 2007 or the date of the
			 enactment of the Pediatric Research Equity Act of 2007, any amendment made by
			 this Act to such a provision applies beginning on the date of the enactment of
			 this Act.
					(2)Transitional
			 rule for adverse event reportingWith respect to a drug for which
			 a labeling change described under section 505A(l)(1) or 505B(i)(1) of the
			 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(l)(1); 355c(i)(1))
			 is approved or made, respectively, during the one-year period that ends on the
			 day before the date of enactment of this Act, the Secretary shall apply section
			 505A(l) and section 505B(i), as applicable, to such drug, as such sections were
			 in effect on such day.
					(f)Conforming
			 amendmentSection 499(c)(1)(C) of the Public Health Service Act
			 (42 U.S.C.
			 290b(c)(1)(C)) is amended by striking for which the
			 Secretary issues a certification in the affirmative under section 505A(n)(1)(A)
			 of the Federal Food, Drug, and Cosmetic Act.
				(g)Public meeting
			 on pediatric cancersNot
			 later than December 31, 2013, the Secretary of Health and Human Services shall
			 hold a public meeting on the impact of sections 505A and 505B of the Federal
			 Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) on the
			 development of new therapies for children with cancer.
				502.Food and Drug
			 Administration Report
				(a)In
			 generalNot later than four
			 years after the date of enactment of this Act and every five years thereafter,
			 the Secretary of Health and Human Services shall prepare and submit to the
			 Committee on Health, Education, Labor and Pensions of the Senate and the
			 Committee on Energy and Commerce of the House of Representatives, and make
			 publicly available, including through posting on the Web site of the Food and
			 Drug Administration, a report on the implementation of section 505A and
			 505B.
				(b)ContentsThe report described in paragraph (1) shall
			 include—
					(1)an assessment of
			 the effectiveness of sections 505A and 505B in improving information about
			 pediatric uses for approved drugs and biologics, including the number and type
			 of labeling changes made since the date of enactment of this Act;
					(2)the number of
			 waivers and partial waivers granted under section 505B since the date of
			 enactment of this Act, and the reasons such waivers and partial waivers were
			 granted;
					(3)the number of
			 deferrals and deferral extensions granted under section 505B since the date of
			 enactment of this Act, and the reasons such deferrals and deferral extensions
			 were granted;
					(4)the number of
			 letters issued under section 505B(d);
					(5)an assessment of
			 the timeliness and effectiveness of pediatric study planning since the date of
			 enactment of this Act, including the number of pediatric plans not submitted in
			 accordance with the requirements of section 505B(e) and any resulting
			 rulemaking;
					(6)the number of
			 written requests issued, accepted, and declined under section 505A since the
			 date of enactment of this Act, and a listing of any important gaps in pediatric
			 information as a result of such declined requests;
					(7)a description and
			 current status of referrals made under section 505A(n);
					(8)an assessment of
			 the effectiveness of studying drugs for rare diseases under 505A;
					(9)an assessment of
			 the effectiveness of studying drugs for children with cancer under 505A and
			 505B, and any recommendations for modifications to the programs under such
			 sections that would lead to new and better therapies for children with
			 cancer;
					(10)an assessment of
			 the effectiveness of studying drugs in the neonate population under 505A and
			 505B;
					(11)an assessment of
			 the effectiveness of studying biological products in pediatric populations
			 under 505A and 505B;
					(12)an assessment of
			 the Secretary’s efforts to address the suggestions and options described in the
			 report required under 505A(p); and
					(13)any suggestions
			 for modification to the programs that would improve pediatric drug research and
			 increase pediatric labeling of drugs and biologics that the Secretary
			 determines to be appropriate.
					(c)Stakeholder
			 commentAt least 180 days
			 prior to the submission of the report required in paragraph (1), the Secretary
			 shall consult with representatives of patient groups, including pediatric
			 patient groups, consumer groups, regulated industry, academia, and other
			 interested parties to obtain any recommendations or information relevant to the
			 study and report including suggestions for modifications that would improve
			 pediatric drug research and pediatric labeling of drugs and biologics.
				503.Internal
			 Committee for Review of Pediatric Plans, Assessments, Deferrals, Deferral
			 Extensions, and WaiversSection 505C (21 U.S.C. 355d) is amended—
				(1)in the section
			 heading, by inserting deferral extensions, after
			 deferrals,; and
				(2)by inserting
			 neonatology after pediatric ethics.
				504.Staff of Office
			 of Pediatric TherapeuticsSection 6(c) of the Best Pharmaceuticals for
			 Children Act (21
			 U.S.C. 393a(c)) is amended—
				(1)in paragraph (1),
			 by striking and at the end;
				(2)by redesignating
			 paragraph (2) as paragraph (4);
				(3)by inserting after
			 paragraph (1) the following:

						(2)one or more additional individuals with
				expertise in neonatology;
						(3)one or more
				additional individuals with expertise in pediatric epidemiology;
				and
						.
				505.Continuation of
			 operation of Pediatric Advisory CommitteeSection 14(d) of the Best Pharmaceuticals
			 for Children Act (42
			 U.S.C. 284m note) is amended by striking during the
			 five-year period beginning on the date of the enactment of the Best
			 Pharmaceuticals for Children Act of 2007 and inserting to carry
			 out the advisory committee’s responsibilities under sections 505A, 505B, and
			 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a,
			 355c, and 360j(m)).
			506.Pediatric
			 Subcommittee of the Oncologic Drugs Advisory CommitteeSection 15(a) of the Best Pharmaceuticals
			 for Children Act (Public Law 107–109), as amended by
			 section 502(e) of the Food and Drug Administration Amendments Act of 2007
			 (Public Law
			 110–85), is amended—
				(1)in paragraph
			 (1)(D), by striking section 505B(f) and inserting section
			 505C; and
				(2)in paragraph (3),
			 by striking during the five-year period beginning on the date of the
			 enactment of the Best Pharmaceuticals for Children Act of 2007 and
			 inserting to carry out the Subcommittee’s responsibilities under this
			 section.
				VIFood
			 and Drug Administration administrative reforms
			601.Public
			 participation in issuance of FDA guidance documentsHR3204Section 701(h)(1) (21 U.S.C. 371(h)(1))
			 is amended by striking subparagraph (C) and inserting the following:

					(C)For any guidance document that sets forth
				initial interpretations of a statute or regulation, sets forth changes in
				interpretation or policy that are of more than a minor nature, includes complex
				scientific issues, or covers highly controversial issues—
						(i)the Secretary—
							(I)at least 30 days before issuance of
				a draft of such guidance document, shall publish notice in the Federal Register
				of the Secretary’s intent to prepare such guidance document; and
							(II)during preparation and before
				issuance of such guidance document, may meet with interested stakeholders,
				including industry, medical, and scientific experts and others, and solicit
				public comment;
							(ii)if the Secretary for good cause finds that,
				with respect to such guidance document, compliance with clause (i) is
				impracticable, unnecessary, or contrary to the public interest—
							(I)the Secretary shall publish such
				finding and a brief statement of the reasons for such finding in the Federal
				Register;
							(II)clause (i) shall not apply with
				respect to such guidance document; and
							(III)during a 90-day period beginning not later
				than the date of issuance of such guidance document, the Secretary may meet
				with interested stakeholders, including industry, medical, and scientific
				experts and others, and shall solicit public comment;
							(iii)beginning on the date of enactment
				of the Food and Drug Administration Reform
				Act of 2012, upon issuance of a draft guidance document under
				clause (i) or (ii), the Secretary shall—
							(I)designate the document as draft or final;
				and
							(II)not later than 18 months after the close of
				the comment period for such guidance, issue a final version of such guidance
				document in accordance with clauses (i) and (ii);
							(iv)the Secretary may extend the deadline for
				issuing final guidance under clause (iii)(II) by not more than 180 days upon
				submission by the Secretary of a notification of such extension in the Federal
				Register;
						(v)if
				the Secretary issues a draft guidance document and fails to finalize the draft
				by the deadline determined under clause (iii)(II), as extended under clause
				(iv), the Secretary shall, beginning on the date of such deadline, treat the
				draft as null and void; and
						(vi)not less than every 5 years after the
				issuance of a final guidance document in accordance with clause (iii), the
				Secretary shall—
							(I)conduct a retrospective analysis of such
				guidance document to ensure it is not outmoded, ineffective, insufficient, or
				excessively burdensome; and
							(II)based on such analysis, modify,
				streamline, expand, or repeal the guidance document in accordance with what has
				been learned.
							(D)With respect to devices, a notice to
				industry guidance letter, a notice to industry advisory letter, and any similar
				notice that sets forth initial interpretations of a statute or regulation or
				sets forth changes in interpretation or policy shall be treated as a guidance
				document for purposes of subparagraph (C).
					(E)The following shall not be treated as a
				guidance document for purposes of subparagraph (C):
						(i)Any document that does not set forth
				an initial interpretation or a reinterpretation of a statute or
				regulation.
						(ii)Any document that sets forth or
				changes a policy relating to internal procedures of the Food and Drug
				Administration.
						(iii)Agency reports, general information
				documents provided to consumers or health professionals, speeches, journal
				articles and editorials, media interviews, press materials, warning letters,
				memoranda of understanding, or communications directed to individual persons or
				firms.
						.
			602.Conflicts of
			 interest
				(a)In
			 generalSection 712
			 (21 U.S.C.
			 379d–1) is amended—
					(1)by striking
			 subsections (b) and (c) and inserting the following subsections:

							(b)Recruitment for
				advisory committees
								(1)In
				generalThe Secretary shall—
									(A)develop and
				implement strategies on effective outreach to potential members of advisory
				committees at universities, colleges, other academic research centers,
				professional and medical societies, and patient and consumer groups;
									(B)seek input from
				professional medical and scientific societies to determine the most effective
				informational and recruitment activities;
									(C)at least every 180
				days, request referrals for potential members of advisory committees from a
				variety of stakeholders, including—
										(i)product
				developers, patient groups, and disease advocacy organizations; and
										(ii)relevant—
											(I)professional
				societies;
											(II)medical
				societies;
											(III)academic
				organizations; and
											(IV)governmental
				organizations; and
											(D)in carrying out subparagraphs (A) and (B),
				take into account the levels of activity (including the numbers of annual
				meetings) and the numbers of vacancies of the advisory committees.
									(2)Recruitment
				activitiesThe recruitment activities under paragraph (1) may
				include—
									(A)advertising the
				process for becoming an advisory committee member at medical and scientific
				society conferences;
									(B)making widely
				available, including by using existing electronic communications channels, the
				contact information for the Food and Drug Administration point of contact
				regarding advisory committee nominations; and
									(C)developing a
				method through which an entity receiving funding from the National Institutes
				of Health, the Agency for Healthcare Research and Quality, the Centers for
				Disease Control and Prevention, or the Veterans Health Administration can
				identify a person whom the Food and Drug Administration can contact regarding
				the nomination of individuals to serve on advisory committees.
									(3)ExpertiseIn carrying out this subsection, the
				Secretary shall seek to ensure that the Secretary has access to the most
				current expert advice.
								(c)Disclosure of
				determinations and certificationsNotwithstanding section
				107(a)(2) of the Ethics in Government Act of 1978, the following shall
				apply:
								(1)15 or more days
				in advanceAs soon as practicable, but (except as provided in
				paragraph (2)) not later than 15 days prior to a meeting of an advisory
				committee to which a written determination as referred to in
				section
				208(b)(1) of title 18, United States Code, or a written
				certification as referred to in section 208(b)(3) of such title, applies, the
				Secretary shall disclose (other than information exempted from disclosure under
				section 552 or section
				552a
				of title 5, United States Code (popularly known as the Freedom of Information
				Act and the Privacy Act of 1974, respectively)) on the Internet Website of the
				Food and Drug Administration—
									(A)the type, nature,
				and magnitude of the financial interests of the advisory committee member to
				which such determination or certification applies; and
									(B)the reasons of the Secretary for such
				determination or certification, including, as appropriate, the public health
				interest in having the expertise of the member with respect to the particular
				matter before the advisory committee.
									(2)Less than 30
				days in advanceIn the case of a financial interest that becomes
				known to the Secretary less than 30 days prior to a meeting of an advisory
				committee to which a written determination as referred to in
				section
				208(b)(1) of title 18, United States Code, or a written
				certification as referred to in section 208(b)(3) of such title applies, the
				Secretary shall disclose (other than information exempted from disclosure under
				section 552 or
				552a
				of title 5, United States Code) on the Internet Website of the Food and Drug
				Administration, the information described in subparagraphs (A) and (B) of
				paragraph (1) as soon as practicable after the Secretary makes such
				determination or certification, but in no case later than the date of such
				meeting.
								;
					(2)in subsection (d),
			 by striking subsection (c)(3) and inserting subsection
			 (c);
					(3)by amending
			 subsection (e) to read as follows:

							(e)Annual
				report
								(1)In
				generalNot later than
				February 1 of each year, the Secretary shall submit to the Committee on
				Appropriations and the Committee on Health, Education, Labor, and Pensions of
				the Senate, and the Committee on Appropriations and the Committee on Energy and
				Commerce of the House of Representatives, a report that describes—
									(A)with respect to the fiscal year that ended
				on September 30 of the previous year, the number of persons nominated for
				participation at meetings for each advisory committee, the number of persons so
				nominated, and willing to serve, the number of vacancies on each advisory
				committee, and the number of persons contacted for service as members on each
				advisory committee meeting for each advisory committee who did not participate
				because of the potential for such participation to constitute a disqualifying
				financial interest under
				section
				208 of title 18, United States Code;
									(B)with respect to
				such year, the number of persons contacted for services as members for each
				advisory committee meeting for each advisory committee who did not participate
				because of reasons other than the potential for such participation to
				constitute a disqualifying financial interest under
				section
				208 of title 18, United States Code;
									(C)with respect to
				such year, the number of members attending meetings for each advisory
				committee; and
									(D)with respect to
				such year, the aggregate number of disclosures required under subsection (d)
				and the percentage of individuals to whom such disclosures did not apply who
				served on such committee.
									(2)Public
				availabilityNot later than 30 days after submitting any report
				under paragraph (1) to the committees specified in such paragraph, the
				Secretary shall make each such report available to the
				public.
								;
				and
					(4)in subsection (f),
			 by striking shall review guidance and all that follows through
			 the end of the subsection and inserting the
			 following:

							shall—(1)review guidance of the Food and Drug
				Administration with respect to advisory committees regarding disclosure of
				conflicts of interest and the application of
				section
				208 of title 18, United States Code; and
							(2)update such
				guidance as necessary to ensure that the Food and Drug Administration receives
				appropriate access to needed scientific expertise, with due consideration of
				the requirements of such section
				208.
							.
					(b)ApplicabilityThe
			 amendments made by subsection (a) apply beginning on October 1, 2012.
				603.Electronic
			 submission of applicationsSubchapter D of chapter VII (21 U.S.C. 379k et
			 seq.) is amended by inserting after section 745 the
			 following:

					745A.Electronic
				format for submissions
						(a)Drugs and
				biologics
							(1)In
				generalBeginning no earlier than 24 months after the issuance of
				a final guidance issued after public notice and opportunity for comment,
				submissions under subsection (b), (i), or (j) of section 505 of this Act or
				subsection (a) or (k) of section 351 of the Public Health Service Act shall be
				submitted in such electronic format as specified by the Secretary in such
				guidance.
							(2)Guidance
				contentsIn the guidance
				under
				paragraph (1), the Secretary
				may—
								(A)provide a
				timetable for establishment by the Secretary of further standards for
				electronic submission as required by such paragraph; and
								(B)set forth criteria
				for waivers of and exemptions from the requirements of this subsection.
								(3)ExceptionThis
				subsection shall not apply to submissions described in section 561.
							(b)Devices
							(1)In
				generalBeginning after the issuance of final guidance
				implementing this paragraph, pre-submissions and submissions for devices under
				section 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of
				this Act or section 351 of the Public Health Service Act, and any supplements
				to such pre-submissions or submissions, shall include an electronic copy of
				such pre-submissions or submissions.
							(2)Guidance
				contentsIn the guidance
				under
				paragraph (1), the Secretary
				may—
								(A)provide standards
				for the electronic copy required under such paragraph; and
								(B)set forth criteria
				for waivers of and exemptions from the requirements of this
				subsection.
								.
			604.Notification of FDA
			 intent to regulate laboratory-developed testsThe Food and Drug Administration may not
			 issue any draft or final guidance on the regulation of laboratory-developed
			 tests under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
			 seq.) without, at least 60 days prior to such issuance—
				(1)notifying the
			 Committee on Energy and Commerce of the House of Representatives and the
			 Committee on Health, Education, Labor, and Pensions of the Senate of the
			 Administration’s intent to take such action; and
				(2)including in such
			 notification the anticipated details of such action.
				VIIMedical device
			 regulatory improvements
			APremarket
			 predictability
				701.Investigational
			 device exemptionsSection
			 520(g) (21 U.S.C.
			 360j(g)) is amended—
					(1)in paragraph
			 (2)(B)(ii), by inserting safety or effectiveness before
			 data obtained; and
					(2)in paragraph (4),
			 by adding at the end the following:

							(C)Consistent with paragraph (1), the
				Secretary shall not disapprove an application under this subsection because the
				Secretary determines that—
								(i)the investigation may not support a
				substantial equivalence or de novo classification determination or approval of
				the device;
								(ii)the investigation may not meet a
				requirement, including a data requirement, relating to the approval or
				clearance of a device; or
								(iii)an additional or different
				investigation may be necessary to support clearance or approval of the
				device.
								.
					702.Clarification
			 of least burdensome standard
					(a)Premarket
			 approvalSection 513(a)(3)(D)
			 (21 U.S.C.
			 360c(a)(3)(D)) is amended—
						(1)by redesignating
			 clause (iii) as clause (v); and
						(2)by inserting after
			 clause (ii) the following:

								(iii)For purposes of clause (ii), the term
				necessary means the minimum required information that would
				support a determination by the Secretary that an application provides
				reasonable assurance of the effectiveness of the device.
								(iv)Nothing in this subparagraph shall
				alter the criteria for evaluating an application for premarket approval of a
				device.
								.
						(b)Premarket
			 notification under section
			 510(k)Section 513(i)(1)(D)
			 (21 U.S.C.
			 360c(i)(1)(D)) is amended—
						(1)by striking ‘‘(D)
			 Whenever’’ and inserting ‘‘(D)(i) Whenever’’; and
						(2)by adding at the
			 end the following:

								(ii)For purposes of clause (i), the term
				necessary means the minimum required information that would
				support a determination of substantial equivalence between a new device and a
				predicate device.
								(iii)Nothing in this subparagraph shall
				alter the standard for determining substantial equivalence between a new device
				and a predicate
				device.
								.
						703.Agency
			 documentation and review of significant decisionsH.R. 3209Chapter V is amended by inserting after
			 section 517 (21
			 U.S.C. 360g) the following:

						517A.Agency
				documentation and review of significant decisions regarding devices
							(a)Documentation of
				rationale for significant decisions
								(1)In
				generalThe Secretary shall completely document the scientific
				and regulatory rationale for any significant decision of the Center for Devices
				and Radiological Health regarding submission or review of a report under
				section 510(k), an application under section 515, or an application for an
				exemption under section 520(g), including documentation of significant
				controversies or differences of opinion and the resolution of such
				controversies or differences of opinion.
								(2)Provision of
				documentationUpon request, the Secretary shall furnish such
				complete documentation to the person who is seeking to submit, or who has
				submitted, such report or application.
								(b)Review of
				significant decisions
								(1)Request for
				supervisory review of significant decisionAny person may request
				a supervisory review of the significant decision described in subsection
				(a)(1). Such review may be conducted at the next supervisory level or higher
				above the individual who made the significant decision.
								(2)Submission of
				requestA person requesting a supervisory review under paragraph
				(1) shall submit such request to the Secretary not later than 30 days after
				such decision and shall indicate in the request whether such person seeks an
				in-person meeting or a teleconference review.
								(3)Timeframe
									(A)In
				generalExcept as provided in subparagraph (B), the Secretary
				shall schedule an in-person or teleconference review, if so requested, not
				later than 30 days after such request is made. The Secretary shall issue a
				decision to the person requesting a review under this subsection not later than
				45 days after the request is made under paragraph (1), or, in the case of a
				person who requests an in-person meeting or teleconference, 30 days after such
				meeting or teleconference.
									(B)ExceptionSubparagraph
				(A) shall not apply in cases that are referred to experts outside of the Food
				and Drug
				Administration.
									.
				704.Transparency in
			 clearance processH.R.
			 3209
					(a)Publication of
			 detailed decision summariesSection 520(h) (21 U.S.C. 360j(h))
			 is amended by adding at the end the following:

							(5)Subject to subsection (c) and section
				301(j), the Secretary shall regularly publish detailed decision summaries for
				each clearance of a device under section 510(k) requiring clinical
				data.
							.
					(b)ApplicationThe requirement of section 520(h)(5) of the
			 Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies only
			 with respect to clearance of a device occurring after the date of the enactment
			 of this Act.
					705.Device
			 Modifications Requiring Premarket Notification Prior to MarketingSection 510(n) (21 U.S.C. 360(n)) is
			 amended by—
					(1)striking
			 (n) The Secretary and inserting (n)(1) The
			 Secretary; and
					(2)by adding at the
			 end the following:

							(2)(A)Not later than 18 months after the
				enactment of this paragraph, the Secretary shall 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 regarding when a
				premarket notification under subsection (k) should be submitted for a
				modification or change to a legally marketed device. The report shall include
				the Secretary’s interpretation of the following terms: could
				significantly affect the safety or effectiveness of the device,
				a significant change or modification in design, material, chemical
				composition, energy source, or manufacturing process,, and major
				change or modification in the intended use of the device. The report
				also shall discuss possible processes for industry to use to determine whether
				a new submission under subsection (k) is required and shall analyze how to
				leverage existing quality system requirements to reduce premarket burden,
				facilitate continual device improvement. and provide reasonable assurance of
				safety and effectiveness of modified devices. In developing such report, the
				Secretary shall consider the input of interested stakeholders.
								(B)The Secretary shall withdraw the Food
				and Drug Administration draft guidance entitled Guidance for Industry
				and FDA Staff—510(k) Device Modifications: Deciding When to Submit a 510(k) for
				a Change to an Existing Device, dated July 27, 2011, and shall not use
				this draft guidance as part of, or for the basis of, any premarket review or
				any compliance or enforcement decisions or actions. The Secretary shall not
				issue—
									(i)any draft guidance or proposed regulation
				that addresses when to submit a premarket notification submission for changes
				and modifications made to a manufacturer’s previously cleared device before the
				receipt by the Committee on Energy and Commerce of the House of Representatives
				and the Committee on Health, Education, Labor, and Pensions of the Senate of
				the report required in subparagraph (A); and
									(ii)any final guidance or regulation
				on that topic for one year after date of receipt of such report by the
				Committee on Energy and Commerce of the House of Representatives and the
				Committee on Health, Education, Labor, and Pensions of the Senate.
									(C)The Food and Drug Administration guidance
				entitled Deciding When to Submit a 510(k) for a Change to an Existing
				Device, dated January 10, 1997, shall be in effect until the subsequent
				issuance of guidance or promulgation, if appropriate, of a regulation described
				in subparagraph (B), and the Secretary shall interpret such guidance in a
				manner that is consistent with the manner in which the Secretary has
				interpreted such guidance since
				1997.
								.
					BPatients Come
			 First
				711.Establishment
			 of schedule and promulgation of regulationH.R.
			 3208
					(a)Establishment of
			 scheduleNot later than 90
			 days after the date of enactment of this Act, the Secretary of Health and Human
			 Services shall establish the schedule referred to in section 515(i)(3) of the
			 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(i)(3)).
					(b)RegulationNot later than one year after the date that
			 the schedule is established under such section 515(i)(3) (as required by
			 subsection (a)) the Secretary shall issue a
			 final regulation under section 515(b) of such Act for each device that the
			 Secretary requires to remain in class III through a determination under section
			 515(i)(2) of such Act.
					712.Program to
			 improve the device recall systemH.R.
			 3208Chapter
			 V is amended by inserting after section 518 (21 U.S.C. 360h) the
			 following:

						518A.Program to
				improve the device recall system
							(a)In
				generalThe Secretary
				shall—
								(1)establish a
				program to routinely and systematically assess information relating to device
				recalls and use such information to proactively identify strategies for
				mitigating health risks presented by defective or unsafe devices;
								(2)clarify procedures
				for conducting device recall audit checks to improve the ability of
				investigators to perform those checks in a consistent manner;
								(3)develop detailed
				criteria for assessing whether a person performing a device recall has
				performed an effective correction or action plan for the recall; and
								(4)document the basis
				for each termination by the Food and Drug Administration of a device
				recall.
								(b)Assessment
				contentThe program established under subsection (a)(1) shall, at
				a minimum, identify—
								(1)trends in the
				number and types of device recalls;
								(2)devices that are
				most frequently the subject of a recall; and
								(3)underlying causes
				of device recalls.
								(c)DefinitionIn this section, the term
				recall means—
								(1)the removal from
				the market of a device pursuant to an order of the Secretary under subsection
				(b) or (e) of section 518; or
								(2)the correction or
				removal from the market of a device at the initiative of the manufacturer or
				importer of the device that is required to be reported to the Secretary under
				section
				519(g).
								.
				CNovel device
			 regulatory relief
				721.Modification of de
			 novo application processH.R.
			 3203
					(a)In
			 generalSection 513(f)(2)
			 (21 U.S.C.
			 360c(f)(2)) is amended—
						(1)by inserting
			 (i) after (2)(A);
						(2)in subparagraph
			 (A)(i), as so designated by paragraph (1), by striking under the
			 criteria set forth and all that follows through the end of subparagraph
			 (A) and inserting a period;
						(3)by adding at the
			 end of subparagraph (A) the following:

								(ii)In lieu of submitting a report under
				section 510(k) and submitting a request for classification under clause (i) for
				a device, if a person determines there is no legally marketed device upon which
				to base a determination of substantial equivalence (as defined in subsection
				(i)), a person may submit a request under this clause for the Secretary to
				classify the device.
								(iii)Upon receipt of a request under
				clause (i) or (ii), the Secretary shall classify the device subject to the
				request under the criteria set forth in subparagraphs (A) through (C) of
				subsection (a)(1) within 120 days.
								(iv)Notwithstanding clause (iii), the Secretary
				may decline to undertake a classification of a device pursuant to a request
				under clause (ii) if the Secretary—
									(I)identifies a legally marketed device
				that would permit a substantial equivalence determination under paragraph (1)
				for the device; or
									(II)determines that the device submitted is not
				of low-moderate risk or special controls to mitigate the risks cannot be
				developed for the device.
									(v)The person submitting the request for
				classification under this subparagraph may recommend to the Secretary a
				classification for the device and shall, if recommending classification in
				class II, include in the request an initial draft proposal for applicable
				special controls, as described in subsection (a)(1)(B), that are necessary, in
				conjunction with general controls, to provide reasonable assurance of safety
				and effectiveness and a description of how the special controls provide such
				assurance. Any such request shall describe the device and provide detailed
				information and reasons for the recommended
				classification.
								;
				and
						(4)in subparagraph (B), by striking Not
			 later than 60 days after the date of the submission of the request under
			 subparagraph (A), the Secretary and inserting The
			 Secretary.
						(b)Conforming
			 amendmentsSection 513(f) of such Act (21 U.S.C. 360c(f))
			 is amended in paragraph (1)—
						(1)in subparagraph
			 (A), by striking , or at the end and inserting a
			 semicolon;
						(2)in subparagraph
			 (B), by striking the period and inserting ; or; and
						(3)by inserting after
			 subparagraph (B) the following:

								(C)the device is classified pursuant to a
				request submitted under paragraph
				(2).
								.
						DKeeping America
			 competitive through harmonization
				731.Harmonization
			 of device premarket review, inspection, and labeling symbols;
			 reportH.R. 3230
					(a)In
			 generalParagraph (4) of section 803(c) (21 U.S.C. 383(c)) is amended to read
			 as follows:

							(4)With respect to devices, the Secretary may,
				when appropriate, enter into arrangements with nations regarding methods and
				approaches to harmonizing regulatory requirements for activities, including
				inspections and common international labeling
				symbols.
							.

					(b)ReportNot later than 3 years after the date of
			 enactment of this Act, the Secretary of Health and Human Services shall submit
			 to the Committee on Health, Education, Labor, and Pensions of the Senate and
			 the Committee on Energy and Commerce of the House of Representatives a report
			 on the Food and Drug Administration’s harmonization activities, itemizing
			 methods and approaches that have been harmonized pursuant to section 803(c)(4)
			 of the Federal Food, Drug, and Cosmetic Act, as amended by subsection
			 (a).
					732.Participation
			 in international foraParagraph (3) of section 803(c)
			 (21 U.S.C.
			 383(c)) is amended—
					(1)by striking
			 (3) and inserting (3)(A); and
					(2)by adding at the
			 end the following:

							(B)In carrying out subparagraph (A), the
				Secretary may participate in appropriate fora, including the International
				Medical Device Regulators Forum, and may—
								(i)provide guidance to such fora on
				strategies, policies, directions, membership, and other activities of a forum
				as appropriate;
								(ii)to the extent appropriate, solicit,
				review, and consider comments from industry, academia, health care
				professionals, and patient groups regarding the activities of such fora;
				and
								(iii)to the extent appropriate, inform
				the public of the Secretary’s activities within such fora, and share with the
				public any documentation relating to a forum’s strategies, policies, and other
				activities of such
				fora.
								.
					EFDA renewing
			 efficiency from outside reviewer management
				741.Reauthorization
			 of Third Party Review
					(a)Periodic
			 reaccreditationSection
			 523(b)(2) (21 U.S.C.
			 360m(b)(2)) is amended by adding at the end of the
			 following:

							(E)Periodic
				reaccreditation
								(i)PeriodSubject to suspension or withdrawal under
				subparagraph (B), any accreditation under this section shall be valid for a
				period of 3 years after its issuance.
								(ii)Response to
				reaccreditation requestUpon the submission of a request by an
				accredited person for reaccreditation under this section, the Secretary shall
				approve or deny such request not later than 60 days after receipt of the
				request.
								(iii)CriteriaNot
				later than 120 days after the date of the enactment of this subparagraph, the
				Secretary shall establish and publish in the Federal Register criteria to
				reaccredit or deny reaccreditation to persons under this section. The
				reaccreditation of persons under this section shall specify the particular
				activities under subsection (a), and the devices, for which such persons are
				reaccredited.
								.
					(b)Duration of
			 authoritySection 523(c) (21 U.S.C. 360m(c)) is amended by
			 striking October 1, 2012 and inserting October 1,
			 2017.
					742.Reauthorization of
			 third party inspectionSection
			 704(g)(11) (21 U.S.C.
			 374(g)(11)) is amended by striking October 1,
			 2012 and inserting October 1, 2017.
				FHumanitarian
			 device reform
				751.Expanded access
			 to humanitarian use devices
					(a)In
			 generalSection 520(m)
			 (21 U.S.C.
			 360j(m)) is amended—
						(1)in paragraph
			 (6)—
							(A)in subparagraph
			 (A)—
								(i)in the matter
			 preceding clause (i), by striking subparagraph (D) and inserting
			 subparagraph (C);
								(ii)by striking
			 clause (i) and inserting the following:

										(i)The device with respect to which the
				exemption is granted—
											(I)is intended for the treatment or
				diagnosis of a disease or condition that occurs in pediatric patients or in a
				pediatric subpopulation, and such device is labeled for use in pediatric
				patients or in a pediatric subpopulation in which the disease or condition
				occurs; or
											(II)is intended for the treatment or
				diagnosis of a disease or condition that does not occur in pediatric patients
				or that occurs in pediatric patients in such numbers that the development of
				the device for such patients is impossible, highly impracticable, or
				unsafe.
											;
								(iii)by striking
			 clause (ii) and inserting the following:

										(ii)During any calendar year, the number of
				such devices distributed during that year under each exemption granted under
				this subsection does not exceed the number of such devices needed to treat,
				diagnose, or cure a population of 4,000 individuals in the United States
				(referred to in this paragraph as the annual distribution
				number).
										;
				and
								(iv)in clause (iv),
			 by striking 2012 and inserting 2017;
								(B)by striking
			 subparagraph (C);
							(C)by redesignating
			 subparagraphs (D) and (E) as subparagraphs (C) and (D), respectively;
			 and
							(D)in subparagraph
			 (C), as so redesignated, by striking and modified under subparagraph
			 (C), if applicable,;
							(2)in paragraph (7),
			 by striking regarding a device and inserting regarding a
			 device described in paragraph (6)(A)(i)(I); and
						(3)in paragraph (8),
			 by striking of all devices described in paragraph (6) and
			 inserting of all devices described in paragraph
			 (6)(A)(i)(I).
						(b)Applicability to
			 Existing DevicesA sponsor of a device for which an exemption was
			 approved under paragraph (2) of section 520(m) of the Federal Food, Drug, and
			 Cosmetic Act (21
			 U.S.C. 360j(m)) before the date of enactment of this Act may
			 seek a determination under subclause (I) or (II) of paragraph (6)(A)(i) of such
			 section 520(m) (as amended by subsection (a)). If the Secretary determines that
			 such subclause (I) or (II) applies with respect to a device, then clauses (ii),
			 (iii), and (iv) of subparagraph (A) and subparagraphs (B), (C), and (D) of
			 paragraph (6) of such section 520(m) shall apply to such device.
					(c)ReportNot
			 later than January 1, 2017, the Comptroller General of the United States shall
			 submit to Congress a report that evaluates and describes—
						(1)the effectiveness
			 of the amendments made by subsection (a) in stimulating innovation with respect
			 to medical devices, including any favorable or adverse impact on pediatric
			 device development;
						(2)the impact of such
			 amendments on pediatric device approvals for devices that received a
			 humanitarian use designation under section 520(m) of the Federal Food, Drug,
			 and Cosmetic Act (21
			 U.S.C. 360j(m)) prior to the date of enactment of this
			 Act;
						(3)the status of
			 public and private insurance coverage of devices granted an exemption under
			 paragraph (2) of such section 520(m) and costs to patients of such
			 devices;
						(4)the impact that
			 paragraph (4) of such section 520(m) has had on access to and insurance
			 coverage of devices granted an exemption under paragraph (2) of such section
			 520(m); and
						(5)the effect of the
			 amendments made by subsection (a) on patients described in such section
			 520(m).
						GRecords and
			 Reports on Devices
				761.Unique device
			 identification system regulationsNot later than 120 days after the date of
			 enactment of this Act, the Secretary of Health and Human Services shall
			 promulgate the regulations required by section 519(f) of the Federal Food,
			 Drug, and Cosmetic Act (21 U.S.C. 360i(f)).
				762.Effective
			 device sentinel program
					(a)Inclusion of
			 devices in postmarket risk identification and analysis systemSection 519 (21 U.S.C. 360i) is amended by
			 adding at the end the following:

							(h)Inclusion of
				devices in postmarket risk identification and analysis system
								(1)In
				generalThe Secretary shall
				amend the procedures established and maintained under clauses (i), (ii), (iii),
				and (v) of section 505(k)(3)(C) in order to expand the postmarket risk
				identification and analysis system established under such section to include
				and apply to devices.
								(2)DataIn
				expanding the system as described in paragraph (1), the Secretary shall use
				relevant data with respect to devices cleared under section 510(k) or approved
				under section 515, which may include claims data, patient survey data, and
				standardized analytic files that allow for the pooling and analysis of data
				from disparate data environments.
								(3)Stakeholder
				inputTo help ensure
				effective implementation of the system as described in paragraph (1) with
				respect to devices, the Secretary shall engage outside stakeholders in
				development of the system, and gather information from outside stakeholders
				regarding the content of an effective sentinel program, through a public
				hearing, advisory committee meeting, maintenance of a public docket, or other
				similar public measures.
								(4)Voluntary
				surveysChapter
				35 of title 44, United States Code, shall not apply to the
				collection of voluntary information from health care providers, such as
				voluntary surveys or questionnaires, initiated by the Secretary for purposes of
				postmarket risk identification, mitigation, and analysis for
				devices.
								.
					(b)Amendments to
			 postmarket risk identification and analysis systemSection
			 505(k)(3)(C)(i) (21
			 U.S.C. 355(k)(3)(C)(i)) is amended—
						(1)by striking
			 subclause (II);
						(2)by redesignating
			 subclauses (III) through (VI) as subclauses (II) through (V), respectively;
			 and
						(3)in item (bb) of
			 subclause (II), as so redesignated, by striking pharmaceutical purchase
			 data and health insurance claims data and inserting medical
			 device utilization data, health insurance claims data, and procedure and device
			 registries.
						HMiscellaneous
				771.Custom
			 devicesSection 520(b)
			 (21 U.S.C.
			 360j) is amended to read as follows:

						(b)Custom
				devices
							(1)In
				generalThe requirements of sections 514 and 515 shall not apply
				to a device that—
								(A)is created or
				modified in order to comply with the order of an individual physician or
				dentist (or any other specially qualified person designated under regulations
				promulgated by the Secretary after an opportunity for an oral hearing);
								(B)in order to comply
				with an order described in subparagraph (A), necessarily deviates from an
				otherwise applicable performance standard under section 514 or requirement
				under section 515;
								(C)is not generally
				available in the United States in finished form through labeling or advertising
				by the manufacturer, importer, or distributor for commercial
				distribution;
								(D)is designed to
				treat a unique pathology or physiological condition that no other device is
				domestically available to treat;
								(E)(i)is intended to meet the
				special needs of such physician or dentist (or other specially qualified person
				so designated) in the course of the professional practice of such physician or
				dentist (or other specially qualified person so designated); or
									(ii)is intended for use by an
				individual patient named in such order of such physician or dentist (or other
				specially qualified person so designated);
									(F)is assembled from components or
				manufactured and finished on a case-by-case basis to accommodate the unique
				needs of individuals described in clause (i) or (ii) of subparagraph (E);
				and
								(G)may have common,
				standardized design characteristics, chemical and material compositions, and
				manufacturing processes as commercially distributed devices.
								(2)LimitationsParagraph
				(1) shall apply to a device only if—
								(A)such device is for
				the purpose of treating a sufficiently rare condition, such that conducting
				clinical investigations on such device would be impractical;
								(B)production of such
				device under paragraph (1) is limited to no more than 5 units per year of a
				particular device type, provided that such replication otherwise complies with
				this section; and
								(C)the manufacturer of such device notifies
				the Secretary on an annual basis, in a manner prescribed by the Secretary, of
				the manufacture of such device.
								(3)GuidanceNot
				later than 2 years after the date of enactment of this section, the Secretary
				shall issue final guidance on replication of multiple devices described in
				paragraph
				(2)(B).
							.
				772.Pediatric
			 device reauthorization
					(a)Final rule
			 relating To tracking of pediatric uses of devicesThe Secretary of Health and Human Services
			 shall issue—
						(1)a
			 proposed rule implementing section 515A(a)(2) of the Federal Food, Drug and
			 Cosmetic Act (21
			 U.S.C. 360e–1(a)(2)) not later than December 31, 2012;
			 and
						(2)a
			 final rule implementing such section not later than December 31, 2013.
						(b)Demonstration
			 grants To improve pediatric device availabilitySection 305(e) of the Pediatric Medical
			 Device Safety and Improvement Act of 2007 (Title III of
			 Public Law
			 110–85) is amended by striking 2008 through 2012
			 and inserting 2013 through 2017.
					773.Report on regulation
			 of health information technology
					(a)ReportNot later than 18 months after the date of
			 the enactment of this Act, the Secretary of Health and Human Services, in
			 consultation with the Commissioner of Food and Drugs, the National Coordinator
			 for Health Information Technology, and the Chairman of the Federal
			 Communications Commission, shall submit to the Committee on Energy and Commerce
			 of the House of Representatives and the appropriate committees of the Senate a
			 report that contains—
						(1)a
			 strategy for coordinating the regulation of health information technology in
			 order to avoid regulatory duplication; and
						(2)recommendations on
			 an appropriate regulatory framework for health information technology,
			 including a risk-based framework.
						(b)DefinitionIn
			 this section, the terms health information technology has the
			 meaning given such term in section 3000(5) of the Public Health Service Act and
			 includes technologies such as electronic health records, personal health
			 records, mobile medical applications, computerized health care provider order
			 entry systems, and clinical decision support.
					VIIIDrug regulatory
			 improvements
			ADrug supply
			 chain
				801.Registration of
			 producers of drugs
					(a)TimingSection 510 (21 U.S.C. 360) is amended—
						(1)in subsection (b)(1), by striking On
			 or before and inserting During the period beginning on October 1
			 and ending on; and
						(2)in subsection
			 (i)(1)(B)(i), by striking on or before and inserting
			 during the period beginning on October 1 and ending on.
						(b)Establishments
			 not duly registered; misbrandingSection 502(o) (21 U.S.C. 352(o)) is
			 amended by striking in any State.
					802.Inspection of
			 drugsSubsection (h) of
			 section 510 (21
			 U.S.C. 360) is amended—
					(1)by striking
			 (h) and inserting (h)(1);
					(2)by inserting
			 with respect to the manufacture, preparation, propagation, compounding,
			 or processing of a device after registered with the Secretary
			 pursuant to this section;
					(3)by striking
			 of a drug or drugs or; and
					(4)by adding at the
			 end the following:

							(2)Inspections with respect to drug
				establishmentsWith respect
				to the manufacture, preparation, propagation, compounding, or processing of a
				drug:
								(A)In generalEvery establishment that is required to be
				registered with the Secretary under this section shall be subject to inspection
				pursuant to section 704.
								(B)Risk-based scheduleIn
				the case of an establishment that is engaged in the manufacture, preparation,
				propagation, compounding, or processing of a drug or drugs (referred to in this
				subsection as a drug establishment), the inspections required
				under subparagraph (A) shall be conducted by officers or employees duly
				designated by the Secretary, on a risk-based schedule established by the
				Secretary.
								(C)Risk factorsIn establishing the risk-based schedule
				under subparagraph (B), the Secretary shall allocate resources to inspect
				establishments according to the known safety risks of such establishments,
				based on the following factors:
									(i)The compliance history of the
				establishment.
									(ii)The inspection frequency and
				history of the establishment, including whether it has been inspected pursuant
				to section 704 within the last four years.
									(iii)The record, history, and nature
				of recalls linked to the establishment.
									(iv)The inherent risk of the drug
				manufactured, prepared, propagated, compounded, or processed at the
				establishment.
									(v)Any other criteria deemed necessary
				and appropriate by the Secretary for purposes of allocating inspection
				resources.
									(D)Effect of statusIn determining the risk associated with an
				establishment for purposes of establishing a risk-based schedule under
				subparagraph (B), the Secretary shall not consider whether the drugs
				manufactured, prepared, propagated, compounded, or processed by such
				establishment are drugs described in section 503(b)(1).
								(E)Annual report on inspections of
				establishmentsNot later than
				February 1 of each year, the Secretary shall submit to Congress a report that
				contains the following:
									(i)The number of domestic and foreign
				establishments registered pursuant to this section in the previous calendar
				year.
									(ii)The number of such registered
				domestic and foreign establishments that the Secretary inspected in the
				previous calendar year.
									(iii)The number of such registered
				establishments that list one or more drugs approved pursuant to an application
				filed under section 505(j).
									(iv)The number of such registered
				establishments that list one or more drugs approved pursuant to an application
				filed under section 505(b).
									(v)The number of registered
				establishments that list both drug products approved pursuant to an application
				filed under section 505(j) and drug products approved pursuant to an
				application filed under section 505(b).
									(vi)A description of how the Secretary
				implemented the risk-based schedule under subparagraph (B) utilizing the
				factors under subparagraph (C).
									(F)Public availability of annual
				reportsThe Secretary shall
				make the report required under subparagraph (E) available to the public on the
				Internet Web site of the Food and Drug
				Administration.
								.
					803.Drug supply
			 quality and safetyParagraph
			 (a) of section 501 (21 U.S.C. 351) is amended by adding
			 at the end the following: For purposes of subparagraph (2)(B), the term
			 current good manufacturing practice includes the implementation of
			 oversight and controls over the manufacture of drugs to ensure quality,
			 including managing the risk of and establishing the safety of raw materials,
			 materials used in the manufacturing of drugs, and finished drug
			 products..
				804.Prohibition
			 against delaying, denying, limiting, or refusing inspection
					(a)In
			 generalSection 501 (21 U.S.C. 351) is
			 amended by adding at the end the following:

							(j)If it is a drug and it has been
				manufactured, processed, packed, or held in any factory, warehouse, or
				establishment and the owner, operator, or agent of such factory, warehouse, or
				establishment delays, denies, or limits an inspection, or refuses to permit
				entry or
				inspection.
							.
					(b)GuidanceNot later than 1 year after the date of
			 enactment of this section, the Secretary of Health and Human Services shall
			 issue guidance that defines the circumstances that would constitute delaying,
			 denying, or limiting inspection, or refusing to permit entry or inspection, for
			 purposes of section 501(j) of the Federal Food, Drug, and Cosmetic Act (as
			 added by
			 subsection (a)).
					805.Destruction of
			 adulterated, misbranded, or counterfeit drugs offered for import
					(a)In
			 generalThe sixth sentence of
			 section 801(a) (21
			 U.S.C. 381(a)) is amended by inserting before the period at the
			 end the following: , except that the Secretary of Health and Human
			 Services, in consultation with the Secretary of Homeland Security, may cause
			 the destruction, without the opportunity for export, of any drug refused
			 admission that has reasonable probability of causing serious adverse health
			 consequences or death, as determined by the Secretary of Health and Human
			 Services, or that is valued at an amount that is $2,000 or less (or such higher
			 amount as the Secretary of Homeland Security may set by regulation pursuant to
			 section 498 of the Tariff Act of 1930 (19 U.S.C. 1498)).
					(b)NoticeSection
			 801(a) (21 U.S.C.
			 381(a)), as amended by
			 subsection (a), is further amended by
			 inserting after the sixth sentence the following: The Secretary of
			 Health and Human Services shall issue regulations providing for notice and an
			 opportunity for a hearing on the destruction of a drug under the previous
			 sentence. For a drug with a value less than and or equal to $2,000 (or, as
			 described in the sixth sentence of this subsection, such higher amount as the
			 Secretary of Homeland Security may set by regulation pursuant to section 498 of
			 the Tariff Act of 1930 (19 U.S.C. 1498)) the regulations
			 under the previous sentence shall provide for prompt notice and an opportunity
			 for a hearing for the owner or consignee before or after the destruction has
			 occurred. For a drug with a value greater than $2,000 (or, as described in the
			 sixth sentence of this subsection, such higher amount as the Secretary of
			 Homeland Security may set by regulation pursuant to section 498 of the Tariff
			 Act of 1930 (19
			 U.S.C. 1498)) that has reasonable probability of causing
			 serious adverse health consequences or death as determined by the Secretary of
			 Health and Human Services, the regulations under the seventh sentence of this
			 subsection shall provide for notice and an opportunity for a hearing to the
			 owner or consignee before the destruction occurs..
					(c)RestitutionIn the regulations described in the seventh
			 sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act (as
			 added by
			 subsection (b)), the Secretary of Health
			 and Human Services shall establish an administrative process whereby an owner
			 or consignee of a drug destroyed without an opportunity for a hearing on
			 destruction may obtain restitution for the value of the drug destroyed under
			 the sixth sentence of such section upon demonstration that such drug was
			 wrongfully destroyed.
					(d)Conforming
			 amendmentThe first sentence
			 of section 801(a) (21
			 U.S.C. 381(a)) is amended by inserting , except as
			 otherwise described in the sixth and seventh sentences of this
			 subsection, after giving notice thereof.
					806.Administrative
			 detention
					(a)In
			 generalSection 304(g)
			 (21 U.S.C.
			 335a(g)) is amended—
						(1)in paragraph (1), by inserting ,
			 drug, after device, each place it appears;
						(2)in paragraph
			 (2)(A), by inserting , drug, after (B), a device;
			 and
						(3)in paragraph
			 (2)(B), by inserting or drug after device each
			 place it appears.
						(b)RegulationNot
			 later than 2 years after the date of the enactment of this Act, the Secretary
			 of Health and Human Services shall promulgate regulations to implement
			 administrative detention authority with respect to drugs, as authorized by the
			 amendments made by
			 subsection (a). Before promulgating such
			 regulations, the Secretary shall consult with stakeholders, including
			 manufacturers of drugs.
					(c)Effective
			 dateThe amendments made by
			 subsection (a) shall not take effect until
			 the Secretary has issued a final regulation under
			 subsection (b).
					807.Enhanced
			 criminal penalty for counterfeit drugs
					(a)In
			 generalSection 303(a)
			 (21 U.S.C.
			 333(a)) is amended by adding at the end the following:

							(3)Notwithstanding paragraph (2), any person
				who engages in any conduct described in section 301(i)(2) knowing or having
				reason to know that the conduct concerns the rendering of a drug as a
				counterfeit drug, or who engages in conduct described in section 301(i)(3)
				knowing or having reason to know that the conduct will cause a drug to be a
				counterfeit drug or knowing or having reason to know that a drug held, sold, or
				dispensed is a counterfeit drug, shall be fined in accordance with title 18,
				United States Code, or imprisoned not more than 20 years, or both, except that
				if the use of the counterfeit drug by a consumer is the proximate cause of the
				death of the consumer, the term of imprisonment shall be any term of years or
				for
				life.
							.
					(b)Conforming
			 amendmentSection 201(g)(2)
			 (21 U.S.C.
			 321(g)(2)) is amended by adding at the end the following
			 sentence: The term counterfeit drug shall not include a
			 drug or placebo intended for use in a clinical trial that is intentionally
			 labeled or marked to maintain proper blinding of the study..
					808.Unique facility
			 identification number
					(a)Domestic
			 establishmentsSection 510
			 (21 U.S.C.
			 360) is amended—
						(1)in subsection
			 (b)(1), by striking and all such establishments and inserting
			 all such establishments, and the unique facility identifier of each such
			 establishment; and
						(2)in subsection (c),
			 by striking and such establishment and inserting such
			 establishment, and the unique facility identifier of such
			 establishment.
						(b)Foreign
			 establishmentsSubparagraph
			 (A) of section 510(i)(1) (21 U.S.C. 360(i)(1)) is amended by
			 inserting the unique facility identifier of the establishment,
			 after the name and place of business of the
			 establishment,.
					(c)GuidanceSection
			 510 (21 U.S.C.
			 360) is amended by adding at the end the following:

							(q)Guidance on
				submission of unique facility identifiers
								(1)In
				generalNot later than 2 years after the date of the enactment of
				this subsection, the Secretary shall, by guidance, specify—
									(A)the unique
				facility identifier system to be used to meet the requirements of—
										(i)subsections
				(b)(1), (c), and (i)(1)(A) of this section; and
										(ii)section 801(s)
				(relating to registration of commercial importers); and
										(B)the form, manner,
				and timing of submissions of unique facility identifiers under the provisions
				specified in subparagraph (A).
									(2)ConsiderationIn
				developing the guidance under
				paragraph (1), the Secretary shall
				take into account the utilization of existing unique identification schemes and
				compatibility with customs automated
				systems.
								.
					(d)ImportationSection
			 801(a) (21 U.S.C.
			 381(a)) is amended by inserting or (5) for an article
			 that is a drug, the appropriate unique facility identifiers under subsection
			 (s) (relating to commercial importers) and section 510(i) (relating to foreign
			 establishments), as specified by the Secretary, are not provided,
			 before then such article shall be refused admission.
					809.Documentation
			 for admissibility of importsSection 801 (21 U.S.C. 381) is amended by adding
			 at the end the following:

						(r)Documentation
							(1)SubmissionThe Secretary may require, in consultation
				with the Secretary of Homeland Security acting through U.S. Customs and Border
				Protection as determined appropriate by the Secretary, the submission of
				documentation or other information for a drug that is imported or offered for
				import into the United States.
							(2)Refusal of
				admissionA drug imported or offered for import into the United
				States shall be refused admission unless all documentation and information the
				Secretary requires under this Act, the Public Health Service Act, or both, as
				appropriate, for such article is submitted.
							(3)Regulations
								(A)Documents and
				informationThe Secretary shall issue a regulation to specify the
				documentation or other information that is described in
				paragraph (1). Such information may
				include—
									(i)information
				demonstrating the regulatory status of the drug, such as the new drug
				application, abbreviated new drug application, or investigational new drug or
				Drug Master File number;
									(ii)facility
				information, such as proof of registration and the unique facility identifier;
				and
									(iii)indication of
				compliance with current good manufacturing practice, such as satisfactory
				testing results, certifications relating to satisfactory inspections, and
				compliance with the country of export regulations.
									(B)ExemptionThe
				Secretary may, by regulation, exempt drugs imported for research purposes only
				and other types of drug imports from some or all of the requirements of this
				subsection.
								(4)Effective
				dateThe final rule under paragraph (3)(A) shall take effect not
				less than 180 days after the Secretary promulgates such final
				rule.
							.
				810.Registration of
			 commercial importers
					(a)ProhibitionsSection 301 (21 U.S.C. 331) is amended by adding
			 at the end the following:

							(aaa)The failure to register in accordance with
				section
				801(s).
							.
					(b)RegistrationSection
			 801 (21 U.S.C.
			 381), as amended by
			 section 809, is further amended by adding at
			 the end the following:

							(s)Registration of
				commercial importers
								(1)RegistrationThe Secretary shall require a commercial
				importer of drugs—
									(A)to be registered
				with the Secretary in a form and manner specified by the Secretary; and
									(B)consistent with the guidance under section
				510(q), to submit, at the time of registration, a unique identifier for the
				principal place of business for which the importer is required to register
				under this subsection.
									(2)Regulations
									(A)In
				generalThe Secretary, in consultation with the Secretary of
				Homeland Security acting through U.S. Customs and Border Protection, shall
				promulgate regulations to establish good importer practices that specify the
				measures an importer shall take to ensure imported drugs are in compliance with
				the requirements of this Act and the Public Health Service Act.
									(B)Expedited
				clearance for certain importersIn promulgating good importer
				practice regulations under
				subparagraph (A), the Secretary may, as
				appropriate, take into account differences among importers and types of
				imports, and, based on the level of risk posed by the imported drug, provide
				for expedited clearance for those importers that volunteer to participate in
				partnership programs for highly compliant companies.
									(3)Discontinuance
				of registrationThe Secretary
				shall discontinue the registration of any commercial importer of drugs that
				fails to comply with the regulations promulgated under this subsection.
								(4)ExemptionsThe
				Secretary, by notice in the Federal Register, may establish exemptions from the
				requirements of this
				subsection.
								.
					(c)MisbrandingSection
			 502(o) (21 U.S.C.
			 352) is amended by inserting if it is a drug and was
			 imported or offered for import by a commercial importer of drugs not duly
			 registered under section 801(s), after not duly registered under
			 section 510,.
					(d)Regulations
						(1)In
			 generalNot later than 36 months after the date of the enactment
			 of this Act, the Secretary of Health and Human Services, in consultation with
			 the Secretary of Homeland Security acting through U.S. Customs and Border
			 Protection, shall promulgate the regulations required to carry out section
			 801(s) of the Federal Food, Drug, and Cosmetic Act, as added by
			 subsection (b).
						(2)Effective
			 dateIn establishing the effective date of the regulations under
			 paragraph (1), the Secretary of Health
			 and Human Services shall, in consultation with the Secretary of Homeland
			 Security acting through U.S. Customs and Border Protection, as determined
			 appropriate by the Secretary of Health and Human Services, provide a reasonable
			 period of time for an importer of a drug to comply with good importer
			 practices, taking into account differences among importers and types of
			 imports, including based on the level of risk posed by the imported
			 product.
						811.Notification
					(a)Prohibited
			 actsSection 301
			 (21 U.S.C.
			 331), as amended by
			 section 810, is further amended by adding at
			 the end the following:

							(bbb)The failure to notify the Secretary in
				violation of section
				568.
							.
					(b)NotificationSubchapter
			 E of chapter V (21
			 U.S.C. 360bbb et seq.) is amended by adding at the end the
			 following:

							568.Notification
								(a)Notification to
				SecretaryWith respect to a
				drug, the Secretary may require notification to the Secretary by a regulated
				person if the regulated person knows—
									(1)that the use of
				such drug in the United States may result in serious injury or death;
									(2)of a significant
				loss or known theft of such drug intended for use in the United States;
				or
									(3)that—
										(A)such drug has been
				or is being counterfeited; and
										(B)(i)the counterfeit product is in commerce in
				the United States or could be reasonably expected to be introduced into
				commerce; or
											(ii)such drug has been or is being imported
				into the United States or may reasonably be expected to be offered for import
				into the United States.
											(b)Manner of
				notificationNotification under this section shall be made in
				such manner and by such means as the Secretary may specify by regulation or
				guidance.
								(c)Savings
				clauseNothing in this
				section shall be construed as limiting any other authority of the Secretary to
				require notifications related to a drug under any other provision of this Act
				or the Public Health Service Act.
								(d)DefinitionIn
				this section, the term regulated person means—
									(1)a person who is
				required to register under section 510 or 801(s);
									(2)a wholesale
				distributor of a drug product; or
									(3)any other person
				that distributes drugs except a person that distributes drugs exclusively for
				retail
				sale.
									.
					812.Exchange of
			 informationSection 708
			 (21 U.S.C.
			 379) is amended—
					(1)by striking
			 The Secretary may provide and inserting the following:

							(a)ContractorsThe Secretary may
				provide
							;
				and
					(2)by adding at the
			 end the following:

							(b)Ability To
				receive and protect confidential informationExcept pursuant to an order of a court of
				the United States, the Secretary shall not be required to disclose under
				section
				552 of title 5, United States Code, or any other provision of
				law, any information relating to drugs obtained from a Federal, State, or local
				government agency, or from a foreign government agency, if the agency has
				requested that the information be kept confidential. For purposes of
				section
				552 of title 5, United States Code, this subsection shall be
				considered a statute described in section 552(b)(3)(B).
							(c)Authority To
				enter into memoranda of understanding for purposes of information
				exchangeThe Secretary may enter into written agreements
				regarding the exchange of information referenced in section 301(j) subject to
				the following criteria:
								(1)CertificationThe Secretary may only enter into written
				agreements under this subsection with foreign governments that the Secretary
				has certified as having the authority and demonstrated ability to protect trade
				secret information from disclosure. Responsibility for this certification shall
				not be delegated to any officer or employee other than the Commissioner of Food
				and Drugs.
								(2)Written
				agreementThe written agreement under this subsection shall
				include a commitment by the foreign government to protect information exchanged
				under this subsection from disclosure unless and until the sponsor gives
				written permission for disclosure or the Secretary makes a declaration of a
				public health emergency pursuant to section 319 of the Public Health Service
				Act that is relevant to the information.
								(3)Information
				exchangeThe Secretary may provide to a foreign government that
				has been certified under paragraph (1), and that has executed a written
				agreement under paragraph (2), information referenced in section 301(j) in the
				following circumstances:
									(A)Information
				concerning the inspection of a facility may be provided if—
										(i)the Secretary
				reasonably believes, or the written agreement described in paragraph (2)
				establishes, that the government has authority to otherwise obtain such
				information; and
										(ii)the written
				agreement executed under paragraph (2) limits the recipient’s use of the
				information to the recipient’s civil regulatory purposes.
										(B)Information not
				described in subparagraph (A) may be provided as part of an investigation, or
				to alert the foreign government to the potential need for an investigation, if
				the Secretary has reasonable grounds to believe that a drug has a reasonable
				probability of causing serious adverse health consequences or death.
									(d)No limitation on
				authorityThis section shall not affect the authority of the
				Secretary to provide or disclose information under any other provision of
				law.
							.
					813.Extraterritorial
			 jurisdictionChapter III
			 (21 U.S.C. 331 et
			 seq.) is amended by adding at the end the following:

						311.Extraterritorial
				jurisdictionThere is
				extraterritorial jurisdiction over any violation of this Act relating to any
				article regulated under this Act if such article was intended for import into
				the United States or if any act in furtherance of the violation was committed
				in the United
				States.
						.
				814.Protection
			 against intentional adulterationSection 303(b) (21 U.S.C. 333(b)) is
			 amended by adding at the end the following:

						(7)Notwithstanding subsection (a)(2), any
				person that knowingly and intentionally engages in an activity that results in
				a drug becoming adulterated under subsection (a)(1), (b), (c), or (d) of
				section 501 and having a reasonable probability of causing serious adverse
				health consequences or death shall be imprisoned for not more than 20 years or
				fined not more than $1,000,000, or
				both.
						.
				815.Records for
			 inspectionSection 704(a)
			 (21 U.S.C.
			 374(a)) is amended by adding at the end the following:

						(4)(A)Any records or other
				information that the Secretary may inspect under this section from a person
				that owns or operates an establishment that is engaged in the manufacture,
				preparation, propagation, compounding, or processing of a drug shall, upon the
				request of the Secretary, be provided to the Secretary by such person, in
				advance of or in lieu of an inspection, within a reasonable timeframe, within
				reasonable limits, and in a reasonable manner, and in either electronic or
				physical form, at the expense of such person. The Secretary’s request shall
				include a sufficient description of the records requested.
							(B)Upon receipt of the records requested
				under
				subparagraph (A), the Secretary shall
				provide to the person confirmation of receipt.
							(C)Nothing in this paragraph supplants
				the authority of the Secretary to conduct inspections otherwise permitted under
				this Act in order to ensure compliance with this
				Act.
							.
				BMedical Gas
			 Safety
				821.Regulation of
			 medical gasesChapter V
			 (21 U.S.C. 351 et
			 seq.) is amended by adding at the end the following:

						GMedical
				gases
							575.DefinitionsIn this subchapter:
								(1)The term
				designated medical gas means any of the following:
									(A)Oxygen that meets
				the standards set forth in an official compendium.
									(B)Nitrogen that
				meets the standards set forth in an official compendium.
									(C)Nitrous oxide that
				meets the standards set forth in an official compendium.
									(D)Carbon dioxide
				that meets the standards set forth in an official compendium.
									(E)Helium that meets
				the standards set forth in an official compendium.
									(F)Carbon monoxide
				that meets the standards set forth in an official compendium.
									(G)Medical air that
				meets the standards set forth in an official compendium.
									(H)Any other medical gas deemed appropriate by
				the Secretary, after taking into account any investigational new drug
				application or investigational new animal drug application for the same medical
				gas submitted in accordance with regulations applicable to such applications in
				title 21 of the Code of Federal Regulations, unless any period of exclusivity
				under section 505(c)(3)(E)(ii) or section 505(j)(5)(F)(ii), or the extension of
				any such period under section 505A, applicable to such medical gas has not
				expired.
									(2)The term
				medical gas means a drug that—
									(A)is manufactured or
				stored in a liquefied, nonliquefied, or cryogenic state; and
									(B)is administered as
				a gas.
									576.Regulation of
				medical gases
								(a)Certification of
				designated medical gases
									(1)SubmissionBeginning
				180 days after the date of enactment of this section, any person may file with
				the Secretary a request for certification of a medical gas as a designated
				medical gas. Any such request shall contain the following information:
										(A)A description of
				the medical gas.
										(B)The name and
				address of the sponsor.
										(C)The name and
				address of the facility or facilities where the medical gas is or will be
				manufactured.
										(D)Any other
				information deemed appropriate by the Secretary to determine whether the
				medical gas is a designated medical gas.
										(2)Grant of
				certificationThe
				certification requested under paragraph (1) is deemed to be granted unless,
				within 60 days of the filing of such request, the Secretary finds that—
										(A)the medical gas
				subject to the certification is not a designated medical gas;
										(B)the request does
				not contain the information required under paragraph (1) or otherwise lacks
				sufficient information to permit the Secretary to determine that the medical
				gas is a designated medical gas; or
										(C)denying the
				request is necessary to protect the public health.
										(3)Effect of
				certification
										(A)In
				general
											(i)Approved
				usesA designated medical gas
				for which a certification is granted under paragraph (2) is deemed, alone or in
				combination, as medically appropriate, with another designated medical gas or
				gases for which a certification or certifications have been granted, to have in
				effect an approved application under section 505 or 512, subject to all
				applicable post-approval requirements, for the following indications for
				use:
												(I)In the case of oxygen, the treatment or
				prevention of hypoxemia or hypoxia.
												(II)In the case of nitrogen, use in hypoxic
				challenge testing.
												(III)In the case of nitrous oxide,
				analgesia.
												(IV)In the case of carbon dioxide, use in
				extracorporeal membrane oxygenation therapy or respiratory stimulation.
												(V)In the case of helium, the treatment of
				upper airway obstruction or increased airway resistance.
												(VI)In the case of medical air, to reduce the
				risk of hyperoxia.
												(VII)In the case of carbon monoxide, use in lung
				diffusion testing.
												(VIII)Any other indication for use for a
				designated medical gas or combination of designated medical gases deemed
				appropriate by the Secretary, unless any period of exclusivity under clause
				(iii) or (iv) of section 505(c)(3)(E), clause (iii) or (iv) of section
				505(j)(5)(F), or section 527, or the extension of any such period under section
				505A, applicable to such indication for use for such gas or combination of
				gases has not expired.
												(ii)LabelingThe
				requirements of sections 503(b)(4) and 502(f) are deemed to have been met for a
				designated medical gas if the labeling on final use container for such medical
				gas bears—
												(I)the information
				required by section 503(b)(4);
												(II)a warning
				statement concerning the use of the medical gas as determined by the Secretary
				by regulation; and
												(III)appropriate
				directions and warnings concerning storage and handling.
												(B)Inapplicability
				of exclusivity provisions
											(i)No exclusivity
				for a certified medical gasNo designated medical gas deemed
				under subparagraph (A)(i) to have in effect an approved application is eligible
				for any period of exclusivity under section 505(c), 505(j), or 527, or the
				extension of any such period under section 505A, on the basis of such deemed
				approval.
											(ii)Effect on
				certificationNo period of exclusivity under section 505(c),
				505(j), or section 527, or the extension of any such period under section 505A,
				with respect to an application for a drug product shall prohibit, limit, or
				otherwise affect the submission, grant, or effect of a certification under this
				section, except as provided in subsection (a)(3)(A)(i)(VIII) and section
				575(1)(H).
											(4)Withdrawal,
				suspension, or revocation of approval
										(A)Withdrawal,
				suspension of approvalNothing in this subchapter limits the
				Secretary's authority to withdraw or suspend approval of a drug product,
				including a designated medical gas deemed under this section to have in effect
				an approved application under section 505 or section 512 of this Act.
										(B)Revocation of
				certificationThe Secretary may revoke the grant of a
				certification under paragraph (2) if the Secretary determines that the request
				for certification contains any material omission or falsification.
										(b)Prescription
				requirement
									(1)In
				generalA designated medical
				gas shall be subject to the requirements of section 503(b)(1) unless the
				Secretary exercises the authority provided in section 503(b)(3) to remove such
				medical gas from the requirements of section 503(b)(1), the gas is approved for
				use without a prescription pursuant to an application under section 505 or 512,
				or the use in question is authorized pursuant to another provision of this Act
				relating to use of medical products in emergencies.
									(2)Oxygen
										(A)No prescription
				required for certain usesNotwithstanding paragraph (1), oxygen
				may be provided without a prescription for the following uses:
											(i)For use in the
				event of depressurization or other environmental oxygen deficiency.
											(ii)For oxygen
				deficiency or for use in emergency resuscitation, when administered by properly
				trained personnel.
											(B)LabelingFor
				oxygen provided pursuant to subparagraph (A), the requirements of section
				503(b)(4) shall be deemed to have been met if its labeling bears a warning that
				the oxygen can be used for emergency use only and for all other medical
				applications a prescription is required.
										577.Inapplicability
				of drug fees to designated medical gasesA designated medical gas, alone or in
				combination with another designated gas or gases (as medically appropriate)
				deemed under section 576 to have in effect an approved application shall not be
				assessed fees under section 736(a) on the basis of such deemed
				approval.
							.
				822.Changes to
			 regulations
					(a)ReportNot later than 18 months after the date of
			 the enactment of this Act, the Secretary, after obtaining input from medical
			 gas manufacturers and any other interested members of the public, shall—
						(1)determine whether
			 any changes to the Federal drug regulations are necessary for medical gases;
			 and
						(2)submit to the
			 Committee on Health, Education, Labor and Pensions of the Senate and the
			 Committee on Energy and Commerce of the House of Representatives a report
			 regarding any such changes.
						(b)RegulationsIf the Secretary determines under
			 subsection (a) that changes to the Federal drug regulations are necessary for
			 medical gases, the Secretary shall issue final regulations revising the Federal
			 drug regulations with respect to medical gases not later than 48 months after
			 the date of the enactment of this Act.
					(c)DefinitionsIn
			 this section:
						(1)The term
			 Federal drug regulations means regulations in title 21 of the Code
			 of Federal Regulations pertaining to drugs.
						(2)The term
			 medical gas has the meaning given to such term in section 575 of
			 the Federal Food, Drug, and Cosmetic Act, as added by section 821 of this
			 Act.
						(3)The term
			 Secretary means the Secretary of Health and Human Services, acting
			 through the Commissioner of Food and Drugs.
						823.Rules of
			 constructionNothing in this
			 subtitle and the amendments made by this subtitle applies with respect
			 to—
					(1)a drug that is
			 approved prior to May 1, 2012, pursuant to an application submitted under
			 section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355,
			 360b);
					(2)any gas listed in
			 subparagraphs (A) through (G) of section 575(1) of the Federal Food, Drug, and
			 Cosmetic Act, as added by section 821 of this Act, or any combination of any
			 such gases, for an indication that—
						(A)is not included
			 in, or is different from, those specified in subclauses (I) through (VII) of
			 section 576(a)(3)(A)(i) of such Act; and
						(B)is approved on or
			 after May 1, 2012, pursuant to an application submitted under Section 505 or
			 512; or
						(3)any designated medical gas added pursuant
			 to subparagraph (H) of section 575(1) of such Act for an indication
			 that—
						(A)is not included
			 in, or is different from, those originally added pursuant to subparagraph (H)
			 of section 575(1) and section 576(a)(3)(A)(i)(VIII); and
						(B)is approved on or
			 after May 1, 2012, pursuant to an application submitted under section 505 or
			 512 of such Act.
						CGenerating
			 Antibiotic Incentives Now
				831.Extension of
			 exclusivity period for drugs
					(a)In
			 generalThe Federal Food, Drug, and Cosmetic Act is amended by
			 inserting after section 505D (21 U.S.C. 355e) the
			 following:

							505E.Extension of
				exclusivity period for new qualified infectious disease products
								(a)ExtensionIf
				the Secretary approves an application pursuant to section 505 for a drug that
				has been determined to be a qualified infectious disease product under
				subsection (d), then the four- and five-year periods described in subsections
				(c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the three-year periods
				described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii)
				and (iv) of subsection (j)(5)(F) of section 505, or the seven year period
				described in section 527, as applicable, shall be extended by five
				years.
								(b)Relation to
				pediatric exclusivityAny extension under subsection (a) of a
				period shall be in addition to any extension of the period under section 505A
				with respect to the drug.
								(c)LimitationsSubsection
				(a) does not apply to the approval of—
									(1)a supplement to an
				application under section 505(b) for any qualified infectious disease product
				for which an extension described in subsection (a) is in effect or has
				expired;
									(2)a subsequent
				application filed by the same sponsor or manufacturer of a qualified infectious
				disease product described in paragraph (1) (or a licensor, predecessor in
				interest, or other related entity) for—
										(A)a change (not
				including a modification to the active moiety of the qualified infectious
				disease product) that results in a new indication, route of administration,
				dosing schedule, dosage form, delivery system, delivery device, or strength;
				or
										(B)a modification to
				the active moiety of the qualified infectious disease product that does not
				result in a change in safety or effectiveness; or
										(3)a product that does not meet the definition
				of a qualified infectious disease product under subsection (f) based upon its
				approved uses.
									(d)DeterminationThe manufacturer or sponsor of a drug may
				request that the Secretary designate a drug as a qualified infectious disease
				product at any time in the drug development process prior to the submission of
				an application under section 505(b) for the drug, but not later than 45 days
				before the submission of such application. The Secretary shall, not later than
				30 days after the submission of such request, determine whether the drug is a
				qualified infectious disease product.
								(e)RegulationsThe
				Secretary shall promulgate regulations for carrying out this section. The
				Secretary shall promulgate the initial regulations for carrying out this
				section not later than 12 months after the date of the enactment of this
				section.
								(f)DefinitionsIn
				this section:
									(1)Qualified
				infectious disease productThe term qualified infectious disease
				product means an antibacterial or antifungal drug for human use that
				treats or prevents an infection caused by a qualifying pathogen.
									(2)Qualifying
				pathogenThe term qualifying pathogen means—
										(A)resistant
				gram-positive pathogens, including methicillin-resistant Staphylococcus aureus
				(MRSA), vancomycin-resistant Staphylococcus aureus (VRSA), and
				vancomycin-resistant enterococcus (VRE);
										(B)multidrug
				resistant gram-negative bacteria, including Acinetobacter, Klebsiella,
				Pseudomonas, and E. coli species;
										(C)multi-drug
				resistant tuberculosis; or
										(D)any other
				infectious pathogen identified for purposes of this section by the
				Secretary.
										.
					(b)ApplicationSection
			 505E of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a),
			 applies only with respect to a drug that is first approved under section 505(c)
			 of such Act (21
			 U.S.C. 355(c)) on or after the date of the enactment of this
			 Act.
					832.Study on
			 incentives for qualified infectious disease biological products
					(a)In
			 generalThe Comptroller
			 General of the United States shall—
						(1)conduct a study on
			 the need for incentives to encourage research on and development and marketing
			 of qualified infectious disease biological products; and
						(2)not later than 1
			 year after the date of the enactment of this Act, submit a report to the
			 Congress on the results of such study, including any recommendations of the
			 Comptroller General on appropriate incentives for addressing such need.
						(b)DefinitionsIn
			 this section:
						(1)The term
			 biological product has the meaning given to such term in section
			 351 of the Public Health Service Act (42 U.S.C. 262).
						(2)The term
			 qualified infectious disease biological product means a biological
			 product for human use that treats or prevents an infection caused by a
			 qualifying pathogen.
						(3)The term
			 qualifying pathogen has the meaning given to such term in section
			 505E of the Federal Food, Drug, and Cosmetic Act, as added by section 831 of
			 this Act.
						833.Clinical
			 trials
					(a)Review and
			 revision of guidelines
						(1)In
			 generalNot later than 1 year after the date of the enactment of
			 this Act, and not later than 4 years thereafter, the Secretary shall—
							(A)review the guidance of the Food and Drug
			 Administration for the conduct of clinical trials with respect to antibacterial
			 and antifungal drugs; and
							(B)as appropriate,
			 revise such guidance to reflect developments in scientific and medical
			 information and technology and to ensure clarity regarding the procedures and
			 requirements for approval of an antibiotic and antifungal drug under chapter V
			 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.).
							(2)Issues for
			 reviewAt a minimum, the review under paragraph (1) shall address
			 the appropriate animal models of infection, in vitro techniques, valid
			 microbiological surrogate markers, the use of noninferiority versus superiority
			 trials, and appropriate delta values for noninferiority trials.
						(3)Rule of
			 constructionExcept to the extent to which the Secretary of
			 Health and Human Services makes revisions under paragraph (1)(B), nothing in
			 this section shall be construed to repeal or otherwise affect the guidance of
			 the Food and Drug Administration.
						(b)Recommendations
			 for investigations
						(1)RequestThe
			 sponsor of a drug intended to be used to treat or prevent a qualifying pathogen
			 may request that the Secretary provide written recommendations for nonclinical
			 and clinical investigations which may be conducted with the drug before it may
			 be approved for such use under section 505 of the Federal Food, Drug, and
			 Cosmetic Act (21
			 U.S.C. 355).
						(2)RecommendationsIf
			 the Secretary has reason to believe that a drug for which a request is made
			 under this subsection is a qualified infectious disease product, the Secretary
			 shall provide the person making the request written recommendations for the
			 nonclinical and clinical investigations which the Secretary believes, on the
			 basis of information available to the Secretary at the time of the request,
			 would be necessary for approval under section 505 of the Federal Food, Drug,
			 and Cosmetic Act (21
			 U.S.C. 355) of such drug for the use described in paragraph
			 (1).
						(c)DefinitionsIn
			 this section:
						(1)The term
			 drug has the meaning given to such term in section 201 of the
			 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
						(2)The term
			 qualified infectious disease product has the meaning given to such
			 term in section 505E of the Federal Food, Drug, and Cosmetic Act, as added by
			 section 831 of this Act.
						(3)The term
			 qualifying pathogen has the meaning given to such term in section
			 505E of the Federal Food, Drug, and Cosmetic Act, as added by section 831 of
			 this Act.
						(4)The term
			 Secretary means the Secretary of Health and Human Services, acting
			 through the Commissioner of Food and Drugs.
						834.Reassessment of
			 qualified infectious disease product incentives in 5 yearsNot later than five years after the date of
			 enactment of this Act, the Secretary of Health and Human Services shall, in
			 consultation with the Food and Drug Administration, Centers for Disease Control
			 and Prevention and other appropriate agencies, 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 that contains the
			 following:
					(1)(A)The number of initial
			 designations of drugs as qualified infectious disease products under section
			 505E of the Federal Food, Drug, and Cosmetic Act;
						(B)the number of qualified infectious
			 disease products approved under this program; and
						(C)whether such products address the need for
			 antibacterial and antifungal drugs to treat serious and life-threatening
			 infections.
						(2)Recommendations—
						(A)based on the
			 information in paragraph (1) and any other relevant data, on any changes that
			 should be made to the list of pathogens that are defined as qualifying
			 pathogens under section 505E(f)(2) of the Federal Food, Drug, and Cosmetic Act,
			 as added by section 831; and
						(B)on whether any additional program (such as
			 the development of public-private collaborations to advance antibacterial drug
			 innovation) or changes to the incentives under this subtitle may be needed to
			 promote the development of antibacterial drugs.
						(3)An examination of—
						(A)the adoption of programs to measure the use
			 of antibacterial drugs in health care settings; and
						(B)the implementation
			 and effectiveness of antimicrobial stewardship protocols across all health care
			 settings.
						(4)Any
			 recommendations for ways to encourage further development and establishment of
			 stewardship programs.
					835.Guidance on
			 pathogen-focused antibacterial drug development
					(a)Draft
			 guidanceNot later than June
			 30, 2013, in order to facilitate the development of antibacterial drugs for
			 serious or life-threatening bacterial infections, particularly in areas of
			 unmet need, the Secretary of Health and Human Services shall publish draft
			 guidance that—
						(1)specifies how
			 preclinical and clinical data can be utilized to inform an efficient and
			 streamlined pathogen-focused antibacterial drug development program that meets
			 the approval standards of the Food and Drug Administration; and
						(2)provides advice on
			 approaches for the development of antibacterial drugs that target a more
			 limited spectrum of pathogens.
						(b)Final
			 guidanceNot later than
			 December 31, 2014, after notice and opportunity for public comment on the draft
			 guidance under
			 subsection (a), the Secretary of Health and
			 Human Services shall publish final guidance consistent with this
			 section.
					DAccelerated
			 approval
				841.Expedited
			 approval of drugs for serious or life-threatening diseases or
			 conditions
					(a)Findings; sense
			 of Congress
						(1)FindingsThe
			 Congress finds as follows:
							(A)The Food and Drug
			 Administration (referred to in this subsection as the FDA)
			 serves a critical role in helping to assure that new medicines are safe and
			 effective. Regulatory innovation is 1 element of the Nation’s strategy to
			 address serious and life-threatening diseases or conditions by promoting
			 investment in and development of innovative treatments for unmet medical
			 needs.
							(B)During the 2
			 decades following the establishment of the accelerated approval mechanism,
			 advances in medical sciences, including genomics, molecular biology, and
			 bioinformatics, have provided an unprecedented understanding of the underlying
			 biological mechanism and pathogenesis of disease. A new generation of modern,
			 targeted medicines is under development to treat serious and life-threatening
			 diseases, some applying drug development strategies based on biomarkers or
			 pharmacogenomics, predictive toxicology, clinical trial enrichment techniques,
			 and novel clinical trial designs, such as adaptive clinical trials.
							(C)As a result of
			 these remarkable scientific and medical advances, the FDA should be encouraged
			 to implement more broadly effective processes for the expedited development and
			 review of innovative new medicines intended to address unmet medical needs for
			 serious or life-threatening diseases or conditions, including those for rare
			 diseases or conditions, using a broad range of surrogate or clinical endpoints
			 and modern scientific tools earlier in the drug development cycle when
			 appropriate. This may result in fewer, smaller, or shorter clinical trials for
			 the intended patient population or targeted subpopulation without compromising
			 or altering the high standards of the FDA for the approval of drugs.
							(D)Patients benefit
			 from expedited access to safe and effective innovative therapies to treat unmet
			 medical needs for serious or life-threatening diseases or conditions.
							(E)For these reasons,
			 the statutory authority in effect on the day before the date of enactment of
			 this Act governing expedited approval of drugs for serious or life-threatening
			 diseases or conditions should be amended in order to enhance the authority of
			 the FDA to consider appropriate scientific data, methods, and tools, and to
			 expedite development and access to novel treatments for patients with a broad
			 range of serious or life-threatening diseases or conditions.
							(2)Sense of
			 CongressIt is the sense of the Congress that the FDA should
			 apply the accelerated approval and fast track provisions set forth in section
			 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356), as amended by this
			 section, to help expedite the development and availability to patients of
			 treatments for serious or life-threatening diseases or conditions while
			 maintaining safety and effectiveness standards for such treatments.
						(b)Expedited
			 approvalSection 506
			 (21 U.S.C.
			 356) is amended to read as follows:

							506.Expedited
				approval of drugs for serious or life-threatening diseases or
				conditions
								(a)Designation of
				drug as a fast track product
									(1)In
				generalThe Secretary shall,
				at the request of the sponsor of a new drug, facilitate the development and
				expedite the review of such drug if it is intended, whether alone or in
				combination with one or more other drugs, for the treatment of a serious or
				life-threatening disease or condition, and it demonstrates the potential to
				address unmet medical needs for such a disease or condition. In this section,
				such a drug is referred to as a fast track product.
									(2)Request for
				designationThe sponsor of a new drug may request the Secretary
				to designate the drug as a fast track product. A request for the designation
				may be made concurrently with, or at any time after, submission of an
				application for the investigation of the drug under section 505(i) of this Act
				or section 351(a)(3) of the Public Health Service Act.
									(3)DesignationWithin
				60 calendar days after the receipt of a request under paragraph (2), the
				Secretary shall determine whether the drug that is the subject of the request
				meets the criteria described in paragraph (1). If the Secretary finds that the
				drug meets the criteria, the Secretary shall designate the drug as a fast track
				product and shall take such actions as are appropriate to expedite the
				development and review of the application for approval of such product.
									(b)Accelerated
				approval of a drug for a serious or life-Threatening disease or condition,
				including a fast track product
									(1)In
				generalThe Secretary may
				approve an application for approval of a product for a serious or
				life-threatening disease or condition, including a fast track product, under
				section 505(c) of this Act or section 351(a) of the Public Health Service Act
				upon making a determination that the product has an effect on—
										(A)a surrogate
				endpoint that is reasonably likely to predict clinical benefit; or
										(B)a clinical
				endpoint that can be measured earlier than irreversible morbidity or mortality,
				that is reasonably likely to predict an effect on irreversible morbidity or
				mortality or other clinical benefit,
										taking into account the severity or
				rarity of the disease or condition and the availability of alternative
				treatments. The evidence to support that an endpoint is reasonably likely to
				predict clinical benefit may include epidemiological, pathophysiologic,
				pharmacologic, therapeutic or other evidence developed using, for example,
				biomarkers, or other scientific methods or tools.(2)LimitationApproval
				of a product under this subsection may, as determined by the Secretary, be
				subject to the following requirements—
										(A)that the sponsor
				conduct appropriate post-approval studies to verify and describe the predicted
				effect of the product on irreversible morbidity or mortality or other clinical
				benefit; and
										(B)that the sponsor
				submit copies of all promotional materials related to the product, at least 30
				days prior to dissemination of the materials—
											(i)during the preapproval review period;
				and
											(ii)following approval, for a period that the
				Secretary determines to be appropriate.
											(3)Expedited
				withdrawal of approvalThe Secretary may withdraw approval of a
				product approved pursuant to this subsection using expedited procedures (as
				prescribed by the Secretary in regulations, which shall include an opportunity
				for an informal hearing) if—
										(A)the sponsor fails
				to conduct any required post-approval study of the product with due
				diligence;
										(B)a study required
				to verify and describe the predicted effect on irreversible morbidity or
				mortality or other clinical benefit of the product fails to verify and describe
				such effect or benefit;
										(C)other evidence
				demonstrates that the product is not safe or effective under the conditions of
				use; or
										(D)the sponsor
				disseminates false or misleading promotional materials with respect to the
				product.
										(c)Review of
				incomplete applications for approval of a fast track product
									(1)In
				generalIf the Secretary
				determines, after preliminary evaluation of clinical data submitted by the
				sponsor, that a fast track product may be effective, the Secretary shall
				evaluate for filing, and may commence review of portions of, an application for
				the approval of the product before the sponsor submits a complete application.
				The Secretary shall commence such review only if the applicant—
										(A)provides a
				schedule for submission of information necessary to make the application
				complete; and
										(B)pays any fee that
				may be required under section 736.
										(2)ExceptionAny
				time period for review of human drug applications that has been agreed to by
				the Secretary and that has been set forth in goals identified in letters of the
				Secretary (relating to the use of fees collected under section 736 to expedite
				the drug development process and the review of human drug applications) shall
				not apply to an application submitted under paragraph (1) until the date on
				which the application is complete.
									(d)Awareness
				effortsThe Secretary shall—
									(1)develop and
				disseminate to physicians, patient organizations, pharmaceutical and
				biotechnology companies, and other appropriate persons a description of the
				provisions of this section applicable to accelerated approval and fast track
				products; and
									(2)establish a
				program to encourage the development of surrogate and clinical endpoints,
				including biomarkers, and other scientific methods and tools that can assist
				the Secretary in determining whether the evidence submitted in an application
				is reasonably likely to predict clinical benefit for serious or
				life-threatening conditions for which there exist significant unmet medical
				needs.
									.
					842.Guidance;
			 amended regulations
					(a)Initial
			 guidanceNot later than one
			 year after the date of enactment of this Act, the Secretary of Health and Human
			 Services (in this subtitle referred to as the Secretary) shall
			 issue draft guidance to implement the amendment made by section 841.
					(b)Final
			 guidanceNot later than one
			 year after the issuance of draft guidance under
			 subsection (a), after an opportunity for
			 public comment, the Secretary shall—
						(1)issue final guidance to implement the
			 amendment made by section 841; and
						(2)amend the regulations governing accelerated
			 approval in parts 314 and 601 of title 21, Code of Federal Regulations, as
			 necessary to conform such regulations with the amendments made by section
			 841.
						(c)ConsiderationsIn
			 developing the guidance under subsections (a) and (b)(1) and the amendments
			 under subsection (b)(2), the Secretary shall consider—
						(1)issues arising under the accelerated
			 approval and fast track processes under section 506 of the Federal Food, Drug,
			 and Cosmetic Act (as amended by section 841) for drugs designated for a rare
			 disease or condition under section 526 of the Federal, Food, Drug, and Cosmetic
			 Act; and
						(2)how to incorporate
			 novel approaches to the review of surrogate endpoints based on pathophysiologic
			 and pharmacologic evidence in such guidance, especially in instances where the
			 low prevalence of a disease renders the existence or collection of other types
			 of data unlikely or impractical.
						(d)No delay in
			 review or approvalThe
			 issuance (or non-issuance) of guidance or conforming regulations implementing
			 the amendments made by section 841 shall not preclude the review of, or action
			 on, a request for designation or an application for approval submitted pursuant
			 to section 506 of the Federal Food, Drug, and Cosmetic Act, as amended by
			 section 841.
					843.Independent
			 review
					(a)In
			 generalThe Secretary may, in
			 conjunction with other planned reviews of the new drug review process, contract
			 with an independent entity with expertise in assessing the quality and
			 efficiency of biopharmaceutical development and regulatory review programs, to
			 evaluate the Food and Drug Administration’s application of the processes
			 described in section 506 of the Federal Food, Drug, and Cosmetic Act, as
			 amended by section 841, and the impact of such processes on the development and
			 timely availability of innovative treatments for patients suffering from
			 serious or life-threatening conditions.
					(b)ConsultationAny
			 evaluation under
			 subsection (a) shall include consultation
			 with regulated industries, patient advocacy and disease research foundations,
			 and relevant academic medical centers.
					ECritical path
			 reauthorization
				851.Reauthorization
			 of the critical path public-private partnershipsSubsection (f) of section 566
			 (21 U.S.C.
			 360bbb–5) is amended to read as follows:

						(f)Authorization of
				appropriationsTo carry out
				this section, there is authorized to be appropriated $6,000,000 for each of
				fiscal years 2013 through
				2017.
						.
				FMiscellaneous
				861.Reauthorization
			 of provision relating to exclusivity of certain drugs containing single
			 enantiomersSection 505(u)(4)
			 (21 U.S.C.
			 355(u)(4)) is amended by striking 2012 and
			 inserting 2017.
				862.Extension of period
			 for first applicant To obtain tentative approval without forfeiting 180-day
			 exclusivity period
					(a)Extension
						(1)In
			 generalIf a first applicant files an application during the
			 30-month period ending on the date of enactment of this Act and such
			 application initially contains a certification described in paragraph
			 (2)(A)(vii)(IV) of section 505(j) of the Federal Food, Drug, and Cosmetic Act
			 (21 U.S.C.
			 355(j)), or if a first applicant files an application and the
			 application is amended during such period to first contain such a
			 certification, the phrase 30 months in paragraph (5)(D)(i)(IV)
			 of such section shall, with respect to such application, be read as
			 meaning—
							(A)during the period
			 beginning on the date of enactment of this Act, and ending on September 30,
			 2013, 45 months;
							(B)during the period
			 beginning on October 1, 2013, and ending on September 30, 2014, 42
			 months;
							(C)during the period beginning on October 1,
			 2014, and ending on September 30, 2015, 39 months; and
							(D)during the period beginning on October 1,
			 2015, and ending on September 30, 2016, 36 months.
							(2)Conforming
			 amendmentIn the case of an
			 application to which an extended period under paragraph (1) applies, the
			 reference to the 30-month period under section 505(q)(1)(G) of the Federal
			 Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(1)(G)) shall be
			 read to be the applicable period under paragraph (1).
						(b)Period for
			 obtaining tentative approval of certain applicationsIf an application is filed on or before the
			 date of enactment of this Act and such application is amended during the period
			 beginning on the day after the date of enactment of this Act and ending on
			 September 30, 2017, to first contain a certification described in paragraph
			 (2)(A)(vii)(IV) of section 505(j) of the Federal Food, Drug, and Cosmetic Act
			 (21 U.S.C.
			 355(j)), the date of the filing of such amendment (rather than
			 the date of the filing of such application) shall be treated as the beginning
			 of the 30-month period described in paragraph (5)(D)(i)(IV) of such section
			 505(j).
					(c)DefinitionsFor the purposes of this section, the terms
			 application and first applicant mean application
			 and first applicant, as such terms are used in section 505(j)(5)(D)(i)(IV) of
			 the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
			 355(j)(5)(D)(i)(IV)).
					863.Final agency action
			 relating to petitions and civil actionsSection 505(q) (21 U.S.C. 355(q)) is
			 amended—
					(1)in paragraph
			 (1)—
						(A)in subparagraph
			 (A), by striking subsection (b)(2) or (j) inserting
			 subsection (b)(2) or (j) of the Act or 351(k) of the Public Health
			 Service Act; and
						(B)in subparagraph
			 (F), by striking 180 days and inserting 150 days;
						(2)in paragraph
			 (2)(A)—
						(A)in the subparagraph heading, by striking
			 180 and inserting 150; and
						(B)in clause (i), by
			 striking 180-day and inserting 150-day;
			 and
						(3)in paragraph (5), by striking
			 subsection (b)(2) or (j) inserting subsection (b)(2) or
			 (j) of the Act or 351(k) of the Public Health Service Act.
					864.Deadline for
			 determination on certain petitions
					(a)In
			 generalSection 505
			 (21 U.S.C.
			 355) is amended by adding at the end the following:

							(w)Deadline for
				determination on certain petitionsThe Secretary shall issue a final,
				substantive determination on a petition submitted pursuant to subsection (b) of
				section
				314.161 of title 21, Code of Federal Regulations (or any
				successor regulations), no later than 270 days after the date the petition is
				submitted.
							.
					(b)ApplicationThe amendment made by
			 subsection (a) shall apply to any petition
			 that is submitted pursuant to subsection (b) of
			 section
			 314.161 of title 21, Code of Federal Regulations (or any
			 successor regulations), on or after the date of enactment of this Act.
					865.Rare pediatric
			 disease priority review voucher incentive programSubchapter B of Chapter V (21 U.S.C. 360aa et
			 seq.) is amended by adding at the end the following:

						529.Priority review
				to encourage treatments for rare pediatric diseases
							(a)DefinitionsIn
				this section:
								(1)Priority
				reviewThe term priority review, with respect to a
				human drug application as defined in section 735(1), means review and action by
				the Secretary on such application not later than 6 months after receipt by the
				Secretary of such application, as described in the Manual of Policies and
				Procedures of the Food and Drug Administration and goals identified in the
				letters described in section 101(b) of the Prescription Drug User Fee
				Amendments of 2012.
								(2)Priority review
				voucherThe term priority review voucher means a
				voucher issued by the Secretary to the sponsor of a rare pediatric disease
				product application that entitles the holder of such voucher to priority review
				of a single human drug application submitted under section 505(b)(1) or section
				351(a) of the Public Health Service Act after the date of approval of the rare
				pediatric disease product application.
								(3)Rare pediatric
				diseaseThe term rare pediatric disease means a
				disease that meets each of the following criteria:
									(A)The disease
				primarily affects individuals aged from birth to 18 years, including age groups
				often called neonates, infants, children, and adolescents.
									(B)The disease is a
				rare disease or condition, within the meaning of section 526.
									(4)Rare pediatric
				disease product applicationThe term rare pediatric disease
				product application means a human drug application, as defined in
				section 735(1), that—
									(A)is for a drug or
				biological product—
										(i)that is for the
				prevention or treatment of a rare pediatric disease; and
										(ii)that contains no
				active ingredient (including any ester or salt of the active ingredient) that
				has been previously approved in any other application under section 505(b)(1),
				505(b)(2), or 505(j) of this Act or section 351(a) or 351(k) of the Public
				Health Service Act;
										(B)is submitted under
				section 505(b)(1) of this Act or section 351(a) of the Public Health Service
				Act;
									(C)the Secretary
				deems eligible for priority review;
									(D)that relies on
				clinical data derived from studies examining a pediatric population and dosages
				of the drug intended for that population;
									(E)that does not seek
				approval for an adult indication in the original rare pediatric disease product
				application; and
									(F)is approved after
				the date of the enactment of the Prescription Drug User Fee Amendments of
				2012.
									(b)Priority Review
				Voucher
								(1)In
				generalThe Secretary shall award a priority review voucher to
				the sponsor of a rare pediatric disease product application upon approval by
				the Secretary of such rare pediatric disease product application.
								(2)Transferability
									(A)In
				generalThe sponsor of a rare pediatric disease product
				application that receives a priority review voucher under this section may
				transfer (including by sale) the entitlement to such voucher. There is no limit
				on the number of times a priority review voucher may be transferred before such
				voucher is used.
									(B)Notification of
				transferEach person to whom a voucher is transferred shall
				notify the Secretary of such change in ownership of the voucher not later than
				30 days after such transfer.
									(3)LimitationA sponsor of a rare pediatric disease
				product application may not receive a priority review voucher under this
				section if the rare pediatric disease product application was submitted to the
				Secretary prior to the date that is 90 days after the date of enactment of the
				Prescription Drug User Fee Amendments of 2012.
								(4)Notification
									(A)In
				generalThe sponsor of a human drug application shall notify the
				Secretary not later than 90 days prior to submission of the human drug
				application that is the subject of a priority review voucher of an intent to
				submit the human drug application, including the date on which the sponsor
				intends to submit the application. Such notification shall be a legally binding
				commitment to pay for the user fee to be assessed in accordance with this
				section.
									(B)Transfer after
				noticeThe sponsor of a human drug application that provides
				notification of the intent of such sponsor to use the voucher for the human
				drug application under
				subparagraph (A) may transfer the
				voucher after such notification is provided, if such sponsor has not yet
				submitted the human drug application described in the notification.
									(5)Termination of
				authorityThe Secretary may
				not award any priority review vouchers under
				paragraph (1) after the last day of the
				1-year period that begins on the date that the Secretary awards the third rare
				pediatric disease priority voucher under this section.
								(c)Priority Review
				User Fee
								(1)In
				generalThe Secretary shall establish a user fee program under
				which a sponsor of a human drug application that is the subject of a priority
				review voucher shall pay to the Secretary a fee determined under paragraph (2).
				Such fee shall be in addition to any fee required to be submitted by the
				sponsor under chapter VII.
								(2)Fee
				amountThe amount of the priority review user fee shall be
				determined each fiscal year by the Secretary, based on the difference
				between—
									(A)the average cost
				incurred by the Food and Drug Administration in the review of a human drug
				application subject to priority review in the previous fiscal year; and
									(B)the average cost
				incurred by the Food and Drug Administration in the review of a human drug
				application that is not subject to priority review in the previous fiscal
				year.
									(3)Annual fee
				settingThe Secretary shall establish, before the beginning of
				each fiscal year beginning after September 30, 2012, the amount of the priority
				review user fee for that fiscal year.
								(4)Payment
									(A)In
				generalThe priority review
				user fee required by this subsection shall be due upon the notification by a
				sponsor of the intent of such sponsor to use the voucher, as specified in
				subsection (b)(4)(A). All other user fees associated with the human drug
				application shall be due as required by the Secretary or under applicable
				law.
									(B)Complete
				applicationAn application described under subparagraph (A) for
				which the sponsor requests the use of a priority review voucher shall be
				considered incomplete if the fee required by this subsection and all other
				applicable user fees are not paid in accordance with the Secretary's procedures
				for paying such fees.
									(C)No waivers,
				exemptions, reductions, or refundsThe Secretary may not grant a waiver,
				exemption, reduction, or refund of any fees due and payable under this
				section.
									(5)Offsetting
				collectionsFees collected pursuant to this subsection for any
				fiscal year—
									(A)shall be deposited
				and credited as offsetting collections to the account providing appropriations
				to the Food and Drug Administration; and
									(B)shall not be
				collected for any fiscal year except to the extent provided in advance in
				appropriation Acts.
									(d)Designation
				process
								(1)In
				generalUpon the request of
				the manufacturer or the sponsor of a new drug, the Secretary may
				designate—
									(A)the new drug as a
				drug for a rare pediatric disease; and
									(B)the application
				for the new drug as a rare pediatric disease product application.
									(2)Request for
				designationThe request for a designation under
				paragraph (1), shall be made at the
				same time a request for designation of orphan disease status under section 526
				or fast-track designation under section 506 is made. Requesting designation
				under this subsection is not a prerequisite to receiving a priority review
				voucher under this section.
								(3)Determination by
				SecretaryNot later than 60 days after a request is submitted
				under
				paragraph (1), the Secretary shall
				determine whether—
									(A)the disease or
				condition that is the subject of such request is a rare pediatric disease;
				and
									(B)the application
				for the new drug is a rare pediatric disease product application.
									(e)Marketing of
				rare pediatric disease products
								(1)In
				generalThe Secretary shall deem a rare pediatric disease product
				application incomplete if such application does not contain a description of
				the plan of the sponsor of such application to market the product in the United
				States.
								(2)RevocationThe Secretary may revoke any priority
				review voucher awarded under
				subsection (b) if the rare pediatric
				disease product for which such voucher was awarded is not marketed in the
				United States within the 365 day period beginning on the date of the approval
				of such drug under section 505 of this Act or section 351 of the Public Health
				Service Act.
								(3)Postapproval
				production reportThe sponsor of an approved rare pediatric
				disease product shall submit a report to the Secretary not later than 5 years
				after the approval of the applicable rare pediatric disease product
				application. Such report shall provide the following information, with respect
				to each of the first 4 years after approval of such product:
									(A)The estimated
				population in the United States suffering from the rare pediatric
				disease.
									(B)The estimated
				demand in the United States for such rare pediatric disease product.
									(C)The actual amount
				of such rare pediatric disease product distributed in the United States.
									(f)Notice and
				report
								(1)Notice of
				issuance of voucher and approval of products under voucherThe Secretary shall publish a notice in the
				Federal Register and on the Web site of the Food and Drug Administration not
				later than 30 days after the occurrence of each of the following:
									(A)The Secretary
				issues a priority review voucher under this section.
									(B)The Secretary approves a drug pursuant to
				an application submitted under section 505(b) of this Act or section 351(a) of
				the Public Health Service Act for which the sponsor of the application used a
				priority review voucher under this section.
									(2)ReportIf, after the last day of the 1-year period
				that begins on the date that the Secretary awards the third rare pediatric
				disease priority voucher under this section, a sponsor of an application
				submitted under section 505(b) of this Act or section 351(a) of the Public
				Health Service Act for a drug uses a priority review voucher under this section
				for such application, the Secretary shall 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 document—
									(A)notifying such
				Committees of the use of such voucher; and
									(B)identifying the
				drug for which such priority review voucher is used.
									(g)Eligibility for
				other programsNothing in this section precludes a sponsor who
				seeks a priority review voucher under this section from participating in any
				other incentive program, including under this Act.
							(h)Relation to
				other provisionsThe provisions of this section shall supplement,
				not supplant, any other provisions of this Act or the Public Health Service Act
				that encourage the development of drugs for tropical diseases and rare
				pediatric diseases.
							(i)GAO study and
				report
								(1)Study
									(A)In
				generalBeginning on the date
				that the Secretary awards the third rare pediatric disease priority voucher
				under this section, the Comptroller General of the United States shall conduct
				a study of the effectiveness of awarding rare pediatric disease priority
				vouchers under this section in the development of on human drug products that
				treat or prevent such diseases.
									(B)Contents of
				studyIn conducting the study under
				subparagraph (A), the Comptroller
				General shall examine the following:
										(i)The indications
				for which each rare disease product for which a priority review voucher was
				awarded was approved under section 505 or section 351 of the Public Health
				Service Act.
										(ii)Whether, and to
				what extent, an unmet need related to the treatment or prevention of a rare
				pediatric disease was met through the approval of such a rare disease
				product.
										(iii)The value of the priority review voucher if
				transferred.
										(iv)Identification of
				each drug for which a priority review voucher was used.
										(v)The length of the
				period of time between the date on which a priority review voucher was awarded
				and the date on which it was used.
										(2)ReportNot
				later than 1 year after the date under
				paragraph (1)(A), the Comptroller
				General shall 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 containing the results of the study under
				paragraph
				(1).
								.
				866.Combating
			 prescription drug abuse
					(a)In
			 generalTo combat the significant rise in prescription drug abuse
			 and the consequences of such abuse, the Secretary of Health and Human Services
			 (referred to in this section as the Secretary), acting through
			 the Commissioner of Food and Drugs (referred to in this section as the
			 Commissioner) and in coordination with other Federal agencies,
			 as appropriate, shall review current Federal initiatives and identify gaps and
			 opportunities with respect to ensuring the safe use of prescription drugs with
			 the potential for abuse.
					(b)ReportNot
			 later than 1 year after the date of enactment of this Act, the Secretary shall
			 issue a report to Congress on the findings of the review under subsection (a).
			 Such report shall include recommendations on—
						(1)how best to
			 leverage and build upon existing Federal and federally funded data sources,
			 such as prescription drug monitoring program data and the sentinel initiative
			 of the Food and Drug Administration under section 505(k)(3) of the Federal
			 Food, Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)), as it relates
			 to collection of information relevant to adverse events, patient safety, and
			 patient outcomes, to create a centralized data clearinghouse and early warning
			 tool;
						(2)how best to
			 develop and disseminate widely best practices models and suggested standard
			 requirements to States for achieving greater interoperability and effectiveness
			 of prescription drug monitoring programs, especially with respect to producing
			 standardized data on adverse events, patient safety, and patient outcomes;
			 and
						(3)how best to
			 develop provider and patient education tools and a strategy to widely
			 disseminate such tools and assess the efficacy of such tools.
						(c)Guidance on
			 tamper-Deterrent productsNot later than 6 months after the date
			 of enactment of this Act, the Secretary, acting through the Commissioner, shall
			 promulgate guidance on the development of tamper-deterrent drug
			 products.
					867.Assessment and
			 modification of REMS
					(a)Assessment and
			 modification of approved strategySection 505–1(g) (21 U.S.C.
			 355–1(g)) is amended—
						(1)in paragraph (1),
			 by striking , and propose a modification to,;
						(2)in paragraph (2)—
							(A)in the matter
			 before subparagraph (A)—
								(i)by striking
			 , subject to paragraph (5),; and
								(ii)by striking
			 , and may propose a modification to,;
								(B)in subparagraph
			 (C), by striking new safety or effectiveness information indicates
			 that and all that follows and inserting the
			 following:

									an assessment is needed to evaluate
			 whether the approved strategy should be modified to—(i)ensure the benefits of the drug outweigh
				the risks of the drug; or
									(ii)minimize the
				burden on the health care delivery system of complying with the
				strategy.
									;
				and
							(C)by striking
			 subparagraph (D);
							(3)in paragraph (3), by striking for a
			 drug shall include— and all that follows and inserting the following
			 for a drug shall include, with respect to each goal included in the
			 strategy, an assessment of the extent to which the approved strategy, including
			 each element of the strategy, is meeting the goal or whether 1 or more such
			 goals or such elements should be modified.; and
						(4)by amending
			 paragraph (4) to read as follows:

								(4)Modification
									(A)On initiative of
				responsible personAfter the
				approval of a risk evaluation and mitigation strategy by the Secretary, the
				responsible person may, at any time, submit to the Secretary a proposal to
				modify the approved strategy. Such proposal may propose the addition,
				modification, or removal of any goal or element of the approved strategy and
				shall include an adequate rationale to support such proposed addition,
				modification, or removal of any goal or element of the strategy.
									(B)On initiative of
				SecretaryAfter the approval
				of a risk evaluation and mitigation strategy by the Secretary, the Secretary
				may, at any time, require a responsible person to submit a proposed
				modification to the strategy within 120 days or within such reasonable time as
				the Secretary specifies, if the Secretary, in consultation with the offices
				described in subsection (c)(2), determines that 1 or more goals or elements
				should be added, modified, or removed from the approved strategy to—
										(i)ensure the
				benefits of the drug outweigh the risks of the drug; or
										(ii)minimize the
				burden on the health care delivery system of complying with the
				strategy.
										.
						(b)Review of
			 proposed strategies; review of assessments and modifications of approved
			 strategiesSection 505–1(h)
			 (21 U.S.C.
			 355–1(h)) is amended—
						(1)in the subsection heading by inserting
			 and
			 Modifications after Review of
			 Assessments;
						(2)in paragraph
			 (1)—
							(A)by inserting
			 and proposed modification to after under subsection (a)
			 and each assessment of; and
							(B)by inserting
			 , and, if necessary, promptly initiate discussions with the responsible
			 person about such proposed strategy, assessment, or modification after
			 subsection (g);
							(3)by striking
			 paragraph (2);
						(4)by redesignating
			 paragraphs (3) through (9) as paragraphs (2) through (8), respectively;
						(5)in paragraph (2),
			 as redesignated by paragraph (4)—
							(A)by amending
			 subparagraph (A) to read as follows:

									(A)In
				general
										(i)TimeframeUnless the dispute resolution process
				described under paragraph (3) or (4) applies, and, except as provided in clause
				(ii) or clause (iii) below, the Secretary, in consultation with the offices
				described in subsection (c)(2), shall review and act on the proposed risk
				evaluation and mitigation strategy for a drug or any proposed modification to
				any required strategy within 180 days of receipt of the proposed strategy or
				modification.
										(ii)Minor
				modificationsThe Secretary shall review and act on a proposed
				minor modification, as defined by the Secretary in guidance, within 60 days of
				receipt of such modification.
										(iii)REMS
				modification due to safety label changesNot later than 60 days after the Secretary
				receives a proposed modification to an approved risk evaluation and mitigation
				strategy to conform the strategy to approved safety label changes, including
				safety labeling changes initiated by the sponsor in accordance with FDA
				regulatory requirements, or to a safety label change that the Secretary has
				directed the holder of the application to make pursuant to section 505(o)(4),
				the Secretary shall review and act on such proposed modification to the
				approved strategy.
										(iv)GuidanceThe
				Secretary shall establish, through guidance, that responsible persons may
				implement certain modifications to an approved risk evaluation and mitigation
				strategy following notification to the
				Secretary.
										;
				and
							(B)by amending
			 subparagraph (C) to read as follows:

									(C)Public
				availabilityUpon acting on a
				proposed risk evaluation and mitigation strategy or proposed modification to a
				risk evaluation and mitigation strategy under subparagraph (A), the Secretary
				shall make publicly available an action letter describing the actions taken by
				the Secretary under such subparagraph
				(A).
									.
							(6)in paragraph (4),
			 as redesignated by paragraph (4)—
							(A)in subparagraph
			 (A)(i)—
								(i)by striking
			 Not earlier than 15 days, and not later than 35 days, after discussions
			 under paragraph (2) have begun, the and inserting The;
			 and
								(ii)by inserting
			 , after the sponsor is required to make a submission under subsection
			 (a)(2) or (g), before request in writing; and
								(B)in subparagraph
			 (I)—
								(i)by striking
			 clauses (i) and (ii); and
								(ii)by striking
			 if the Secretary— and inserting if the Secretary has
			 complied with the timing requirements of scheduling review by the Drug Safety
			 Oversight Board, providing a written recommendation, and issuing an action
			 letter under subparagraphs (B), (F), and (G), respectively.;
								(7)in paragraph (5),
			 as redesignated by paragraph (4)—
							(A)in subparagraph
			 (A), by striking any of subparagraphs (B) through (D) and
			 inserting subparagraph (B) or (C); and
							(B)in subparagraph
			 (C), by striking paragraph (4) or (5) and inserting
			 paragraph (3) or (4); and
							(8)in paragraph (8),
			 as redesignated by paragraph (4), by striking paragraphs (7) and
			 (8) and inserting paragraphs (6) and (7)..
						(c)GuidanceNot later than 1 year after the date of
			 enactment of this Act, the Secretary of Health and Human Services shall issue
			 guidance that, for purposes of section 505–1(h)(2)(A) of the Federal Food,
			 Drug, and Cosmetic Act (21 U.S.C. 355–1(h)(2)(A)),
			 describes the types of modifications to approved risk evaluation and mitigation
			 strategies that shall be considered to be minor modifications of such
			 strategies.
					868.Consultation with
			 external experts on rare diseases, targeted therapies, and genetic targeting of
			 treatmentsSubchapter E of
			 chapter V (21
			 U.S.C. 360bbb et seq.), as amended by section 811(b), is
			 further amended by adding at the end the following:

						569.Consultation
				with external experts on rare diseases, targeted therapies, and genetic
				targeting of treatments
							(a)In
				generalFor the purpose of
				promoting the efficiency of and informing the review by the Food and Drug
				Administration of new drugs and biological products for rare diseases and drugs
				and biological products that are genetically targeted, the following shall
				apply:
								(1)Consultation
				with stakeholdersConsistent
				with sections X.C and IX.E.4 of the PDUFA Reauthorization Performance Goals and
				Procedures Fiscal Years 2013 through 2017, as referenced in the letters
				described in section 101(b) of the Prescription Drug User Fee Amendments of
				2012, the Secretary shall ensure that opportunities exist, at a time the
				Secretary determines appropriate, for consultations with stakeholders on the
				topics described in subsection (b).
								(2)Consultation
				with external experts
									(A)In
				generalThe Secretary shall develop and maintain a list of
				external experts who, because of their special expertise, are qualified to
				provide advice on rare disease issues, including topics described in subsection
				(c). The Secretary may, when appropriate to address a specific regulatory
				question, consult such external experts on issues related to the review of new
				drugs and biological products for rare diseases and drugs and biological
				products that are genetically targeted, including the topics described in
				subsection (b), when such consultation is necessary because the Secretary lacks
				the specific scientific, medical, or technical expertise necessary for the
				performance of the Secretary’s regulatory responsibilities and the necessary
				expertise can be provided by the external experts.
									(B)External
				expertsFor purposes of subparagraph (A), external experts are
				individuals who possess scientific or medical training that the Secretary lacks
				with respect to one or more rare diseases.
									(b)Topics for
				consultationTopics for consultation pursuant to this section may
				include—
								(1)rare
				diseases;
								(2)the severity of
				rare diseases;
								(3)the unmet medical
				need associated with rare diseases;
								(4)the willingness
				and ability of individuals with a rare disease to participate in clinical
				trials;
								(5)an assessment of
				the benefits and risks of therapies to treat rare diseases;
								(6)the general design
				of clinical trials for rare disease populations and subpopulations; and
								(7)the demographics
				and the clinical description of patient populations.
								(c)Classification
				as special government employeesThe external experts who are
				consulted under this section may be considered special government employees, as
				defined under section
				202 of title 18, United States Code.
							(d)Protection of
				confidential information and trade secrets
								(1)Rule of
				constructionNothing in this
				section shall be construed to alter the protections offered by laws,
				regulations, and policies governing disclosure of confidential commercial or
				trade secret information, and any other information exempt from disclosure
				pursuant to section
				552(b) of title 5, United States Code, as such provisions would
				be applied to consultation with individuals and organizations prior to the date
				of enactment of this section.
								(2)Consent required
				for disclosureThe Secretary
				shall not disclose confidential commercial or trade secret information to an
				expert consulted under this section without the written consent of the sponsor
				unless the expert is a special government employee (as defined under
				section
				202 of title 18, United States Code) or the disclosure is
				otherwise authorized by law.
								(e)Other
				consultationNothing in this section shall be construed to limit
				the ability of the Secretary to consult with individuals and organizations as
				authorized prior to the date of enactment of this section.
							(f)No right or
				obligation
								(1)No right to
				consultationNothing in this section shall be construed to create
				a legal right for a consultation on any matter or require the Secretary to meet
				with any particular expert or stakeholder.
								(2)No altering of
				goalsNothing in this section shall be construed to alter agreed
				upon goals and procedures identified in the letters described in section 101(b)
				of the Prescription Drug User Fee Amendments of 2012.
								(3)No change to
				number of review cyclesNothing in this section is intended to
				increase the number of review cycles as in effect before the date of enactment
				of this section.
								(g)No delay in
				product reviewPrior to a consultation with an external expert,
				as described in this section, relating to an investigational new drug
				application under section 505(i), a new drug application under section 505(b),
				or a biologics license application under section 351 of the Public Health
				Service Act, the Director of the Center for Drug Evaluation and Research or the
				Director of the Center for Biologics Evaluation and Research (or appropriate
				Division Director), as appropriate, shall determine that—
								(1)such consultation
				will—
									(A)facilitate the
				Secretary’s ability to complete the Secretary’s review;
									(B)address
				outstanding deficiencies in the application; and
									(C)increase the
				likelihood of an approval decision in the current review cycle; or
									(2)the sponsor
				authorized such
				consultation.
								.
				869.Breakthrough
			 therapies
					(a)In
			 generalSection 506
			 (21 U.S.C.
			 356), as amended by section 841, is further amended—
						(1)by redesignating
			 subsection (d) as subsection (e);
						(2)by redesignating
			 subsections (a) through (c) as subsections (b) through (d),
			 respectively;
						(3)by inserting
			 before subsection (b), as so redesignated, the following:

								(a)Designation of a
				drug as a breakthrough therapy
									(1)In
				generalThe Secretary shall, at the request of the sponsor of a
				drug, expedite the development and review of such drug if the drug is intended,
				alone or in combination with 1 or more other drugs, to treat a serious or
				life-threatening disease or condition and preliminary clinical evidence
				indicates that the drug may demonstrate substantial improvement over existing
				therapies on 1 or more clinically significant endpoints, such as substantial
				treatment effects observed early in clinical development. In this section, such
				a drug is referred to as a breakthrough therapy.
									(2)Request for
				designationThe sponsor of a drug may request the Secretary to
				designate the drug as a breakthrough therapy. A request for the designation may
				be made concurrently with, or at any time after, the submission of an
				application for the investigation of the drug under section 505(i) or section
				351(a)(3) of the Public Health Service Act.
									(3)Designation
										(A)In
				generalNot later than 60 calendar days after the receipt of a
				request under paragraph (2), the Secretary shall determine whether the drug
				that is the subject of the request meets the criteria described in paragraph
				(1). If the Secretary finds that the drug meets the criteria, the Secretary
				shall designate the drug as a breakthrough therapy and shall take such actions
				as are appropriate to expedite the development and review of the application
				for approval of such drug.
										(B)ActionsThe
				actions to expedite the development and review of an application under
				subparagraph (A) may include, as appropriate—
											(i)holding meetings
				with the sponsor and the review team throughout the development of the
				drug;
											(ii)providing timely
				advice to, and interactive communication with, the sponsor regarding the
				development of the drug to ensure that the development program to gather the
				non-clinical and clinical data necessary for approval is as efficient as
				practicable;
											(iii)involving senior
				managers and experienced review staff, as appropriate, in a collaborative,
				cross-disciplinary review;
											(iv)assigning a
				cross-disciplinary project lead for the Food and Drug Administration review
				team to facilitate an efficient review of the development program and to serve
				as a scientific liaison between the review team and the sponsor; and
											(v)taking steps to
				ensure that the design of the clinical trials is as efficient as practicable,
				when scientifically appropriate, such as by minimizing the number of patients
				exposed to a potentially less efficacious
				treatment.
											;
						(4)in subsection
			 (e)(1), as so redesignated, by striking applicable to accelerated
			 approval and inserting applicable to breakthrough therapies,
			 accelerated approval,; and
						(5)by adding at the
			 end the following:

								(f)ReportBeginning
				in fiscal year 2013, the Secretary shall annually prepare and submit to the
				Committee on Health, Education, Labor, and Pensions of the Senate and the
				Committee on Energy and Commerce of the House of Representatives, and make
				publicly available, with respect to this section for the previous fiscal
				year—
									(1)the number of
				drugs for which a sponsor requested designation as a breakthrough
				therapy;
									(2)the number of
				products designated as a breakthrough therapy; and
									(3)for each product
				designated as a breakthrough therapy, a summary of the actions taken under
				subsection
				(a)(3).
									.
						(b)Guidance;
			 amended regulations
						(1)In
			 general
							(A)GuidanceNot
			 later than 18 months after the date of enactment of this Act, the Secretary of
			 Health and Human Services (referred to in this section as the
			 Secretary) shall issue draft guidance on implementing the
			 requirements with respect to breakthrough therapies, as set forth in section
			 506(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)),
			 as amended by this section. The Secretary shall issue final guidance not later
			 than 1 year after the close of the comment period for the draft
			 guidance.
							(B)Amended
			 regulations
								(i)In
			 generalIf the Secretary determines that it is necessary to amend
			 the regulations under title 21, Code of Federal Regulations in order to
			 implement the amendments made by this section to section 506(a) of the Federal
			 Food, Drug, and Cosmetic Act, the Secretary shall amend such regulations not
			 later than 2 years after the date of enactment of this Act.
								(ii)ProcedureIn
			 amending regulations under clause (i), the Secretary shall—
									(I)issue a notice of
			 proposed rulemaking that includes the proposed regulation;
									(II)provide a period
			 of not less than 60 days for comments on the proposed regulation; and
									(III)publish the
			 final regulation not less than 30 days before the effective date of the
			 regulation.
									(iii)RestrictionsNotwithstanding
			 any other provision of law, the Secretary shall promulgate regulations
			 implementing the amendments made by section only as described in clause
			 (ii).
								(2)RequirementsGuidance
			 issued under this section shall—
							(A)specify the
			 process and criteria by which the Secretary makes a designation under section
			 506(a)(3) of the Federal Food, Drug, and Cosmetic Act; and
							(B)specify the
			 actions the Secretary shall take to expedite the development and review of a
			 breakthrough therapy pursuant to such designation under such section 506(a)(3),
			 including updating good review management practices to reflect breakthrough
			 therapies.
							(c)Independent
			 reviewNot later than 3 years after the date of enactment of this
			 Act, the Comptroller General of the United States, in consultation with
			 appropriate experts, shall assess the manner by which the Food and Drug
			 Administration has applied the processes described in section 506(a) of the
			 Federal Food, Drug, and Cosmetic Act, as amended by this section, and the
			 impact of such processes on the development and timely availability of
			 innovative treatments for patients affected by serious or life-threatening
			 conditions. Such assessment shall be made publicly available upon
			 completion.
					(d)Conforming
			 amendmentsSection 506B(e) (21 U.S.C. 356b) is amended by
			 striking section 506(b)(2)(A) each place such term appears and
			 inserting section 506(c)(2)(A).
					870.Grants and
			 Contracts for the Development of Orphan Drugs
					(a)Qualified
			 testing definitionSection
			 5(b)(1)(A)(ii) of the Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A)(ii)) is
			 amended by striking after the date such drug is designated under section
			 526 of such Act and.
					(b)Authorization of
			 AppropriationsSection 5(c)
			 of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended to
			 read as follows:

							(c)Authorization of
				appropriationsFor grants and
				contracts under subsection (a), there is authorized to be appropriated
				$30,000,000 for each of fiscal years 2013 through
				2017.
							.
					IXDrug
			 shortages
			901.Discontinuance
			 and interruptions of manufacturing of certain drugs
				(a)In
			 generalSection 506C
			 (21 U.S.C.
			 356c) is amended to read as follows:

						506C.Discontinuance
				and interruptions of manufacturing of certain drugs
							(a)In
				generalA manufacturer of a
				drug subject to section 503(b)(1)—
								(1)that is—
									(A)life-supporting;
									(B)life-sustaining;
				or
									(C)intended for use
				in the prevention or treatment of a debilitating disease or condition;
				and
									(2)that is not a radio pharmaceutical drug
				product, a product derived from human plasma protein and their recombinant
				analogs, or any other product as designated by the Secretary,
								shall notify the Secretary of a
				discontinuance of the manufacture of the drug, or an interruption of the
				manufacture of the drug that is likely to lead to a meaningful disruption in
				the manufacturer’s supply of the drug, and the reason for such discontinuance
				or interruption, in accordance with subsection (b).(b)TimingA notice required by subsection (a) shall
				be submitted to the Secretary—
							(1)at least 6 months
				prior to the date of the discontinuance or interruption; or
							(2)if compliance with
				paragraph (1) is not possible, as soon as practicable.
							(c)DistributionTo the maximum extent practicable, the
				Secretary shall distribute information on the discontinuation or interruption
				of the manufacture of the drugs described in subsection (a) to appropriate
				organizations, including physician, health provider, and patient organizations,
				as described in section 506D.
						(d)ConfidentialityNothing
				in this section shall be construed as authorizing the Secretary to disclose any
				information that is a trade secret or confidential information subject to
				section
				552(b)(4) of title 5, United States Code, or
				section
				1905 of title 18, United States Code.
						(e)Coordination
				with Attorney GeneralNot
				later than 30 days after the receipt of a notification described in subsection
				(a), the Secretary shall—
							(1)determine whether
				the notification pertains to a controlled substance subject to a production
				quota under section 306 of the Controlled Substances Act; and
							(2)if necessary, as
				determined by the Secretary—
								(A)notify the
				Attorney General that the Secretary has received such a notification;
								(B)request that the
				Attorney General increase the aggregate and individual production quotas under
				section 306 of the Controlled Substances Act applicable to such controlled
				substance and any ingredient therein to a level the Secretary deems necessary
				to address a shortage of a controlled substance based on the best available
				market data; and
								(C)if the Attorney
				General determines that the level requested is not necessary to address a
				shortage of a controlled substance, the Attorney General shall provide to the
				Secretary a written response detailing the basis for the Attorney General’s
				determination.
								The Secretary shall make the written
				response provided under subparagraph (C) available to the public on the Web
				site of the Food and Drug Administration.(f)Failure To meet
				requirementsIf a person
				fails to submit information required under subsection (a) in accordance with
				subsection (b)—
							(1)the Secretary
				shall issue a letter to such person informing such person of such
				failure;
							(2)not later than 30
				calendar days after the issuance of a letter under paragraph (1), the person
				who receives such letter shall submit to the Secretary a written response to
				such letter setting forth the basis for noncompliance and providing information
				required under subsection (a); and
							(3)not later than 45
				calendar days after the issuance of a letter under paragraph (1), the Secretary
				shall make such letter and any response to such letter under paragraph (2)
				available to the public on the Web site of the Food and Drug Administration,
				with appropriate redactions made to protect information described in subsection
				(d), except that, if the Secretary determines that the letter under paragraph
				(1) was issued in error or, after review of such response, the person had a
				reasonable basis for not notifying as required under subsection (a), the
				requirements of this paragraph shall not
				apply.
							.
				(b)Regulations
					(1)In
			 generalNot later than 18 months after the date of the enactment
			 of this Act, the Secretary of Health and Human Services, after issuing a notice
			 of proposed rule and holding a public hearing, shall promulgate final
			 regulations that implement the amendment made by subsection (a).
					(2)ContentsSuch
			 regulations shall, for purposes of section 506C of the Federal Food, Drug, and
			 Cosmetic Act (21
			 U.S.C. 356c)—
						(A)define the terms
			 life-supporting, life-sustaining, and intended
			 for use in the prevention or treatment of a debilitating disease or
			 condition; and
						(B)define the term
			 interruption of the manufacture of the drug that is likely to lead to a
			 meaningful disruption in the manufacturer’s supply of the drug to mean a
			 change in production that is highly likely to lead to more than a negligible
			 reduction in the supply of the drug and affects the ability of the manufacturer
			 to meet demand for such drug, but not to include a change in production due to
			 matters such as routine maintenance or insignificant changes in manufacturing
			 so long as the manufacturer expects to resume operations in a short period of
			 time.
						902.Drug shortage
			 listTitle V (21 U.S.C. 351 et
			 seq.) is amended by inserting after section 506C the following
			 new section:

					506D.Drug shortage
				list
						(a)EstablishmentThe Secretary shall maintain an up-to-date
				list of drugs that are determined by the Secretary to be in shortage in the
				United States.
						(b)ContentsFor
				each drug on such list, the Secretary shall include the following
				information:
							(1)The name of the
				drug in shortage.
							(2)The name of each
				manufacturer of such drug.
							(3)The reason for the shortage, as determined
				by the Secretary, selecting from the following categories:
								(A)Requirements
				related to complying with good manufacturing practices.
								(B)Regulatory
				delay.
								(C)Shortage of an
				active ingredient.
								(D)Shortage of an
				inactive ingredient component.
								(E)Discontinuation of
				the manufacture of the drug.
								(F)Delay in shipping
				of the drug.
								(G)Demand increase
				for the drug.
								(4)The estimated
				duration of the shortage as determined by the Secretary.
							(c)Public
				availability
							(1)In
				generalSubject to paragraphs (2) and (3), the Secretary shall
				make the information in such list publicly available.
							(2)Trade secrets
				and confidential informationNothing in this section alters or amends
				section
				1905 of title 18, United States Code, or
				section
				552(b)(4) of title 5 of such Code.
							(3)Public health
				exceptionThe Secretary may
				choose not to make information collected under this section publicly available
				under
				paragraph (1) if the Secretary
				determines that disclosure of such information would adversely affect the
				public health (such as by increasing the possibility of hoarding or other
				disruption of the availability of drug products to
				patients).
							.
			903.Quotas
			 applicable to drugs in shortageSection 306 of the Controlled Substances Act
			 (21 U.S.C.
			 826) is amended by adding at the end the following:

					(h)(1)Not later than 30 days
				after the receipt of a request described in paragraph (2), the Attorney General
				shall—
							(A)complete review of such request;
				and
							(B)(i)as necessary to address a shortage of a
				controlled substance, increase the aggregate and individual production quotas
				under this section applicable to such controlled substance and any ingredient
				therein to the level requested; or
								(ii)if the Attorney General determines that the
				level requested is not necessary to address a shortage of a controlled
				substance, the Attorney General shall provide a written response detailing the
				basis for the Attorney General’s determination.
								The Secretary shall make the
				written response provided under subparagraph (B)(ii) available to the public on
				the Web site of the Food and Drug Administration.(2)A request is described in this
				paragraph if—
							(A)the request pertains to a controlled
				substance on the list of drugs in shortage maintained under section 506D of the
				Federal Food, Drug, and Cosmetic Act;
							(B)the request is submitted by the
				manufacturer of the controlled substance; and
							(C)the controlled substance is in
				schedule
				II.
							.
			904.Expedited
			 review of major manufacturing changes for potential and verified shortages of
			 drugs that are life-supporting, life-sustaining, or intended for use in the
			 prevention of a debilitating disease or conditionSubsection (c) of section 506A
			 (21 U.S.C.
			 356a) is amended by adding at the end the following new
			 paragraph:

					(3)Changes
				addressing a drug shortage
						(A)Certification
							(i)DescriptionA certification is described in this
				subparagraph if the manufacturer, having notified the Secretary of an
				interruption or discontinuance of a drug in accordance with Section 506C,
				certifies (in such certification) that the major manufacturing change for which
				approval is being sought may prevent or alleviate a discontinuance or
				interruption of such drug.
							(ii)Bad faith
				exceptionSubparagraphs (B) and (C) do not apply in the case of a
				certification which the Secretary determines to be made in bad faith.
							(B)Expedited
				reviewIf a certification
				described in subparagraph (A) is submitted in connection with a supplemental
				application for a major manufacturing change, the Secretary shall—
							(i)expedite any technical review or inspection
				necessary for consideration of the supplemental application;
							(ii)provide any
				technical assistance necessary to facilitate approval of the supplemental
				application; and
							(iii)not later than 60 days after receipt of the
				certification, complete review of the supplemental
				application.
							.
			905.Study on drug
			 shortages
				(a)StudyThe Comptroller General of the United
			 States shall conduct a study to examine the cause of drug shortages and
			 formulate recommendations on how to prevent or alleviate such shortages.
				(b)ConsiderationIn
			 conducting the study under this section, the Comptroller General shall consider
			 the following questions:
					(1)What are the
			 dominant characteristics of drugs that have gone into actual shortage over the
			 preceding three years?
					(2)Are there systemic high-risk factors (such
			 as drug pricing structure, including Federal reimbursements, or the number of
			 manufacturers producing a drug product) that have led to the concentration of
			 drug shortages in certain drug products that have made such products vulnerable
			 to drug shortages?
					(3)Is there a reason
			 why drug shortages have occurred primarily in the sterile injectable market and
			 in certain therapeutic areas?
					(4)How have regulations, guidance documents,
			 regulatory practices, and other actions of Federal departments and agencies
			 (including the effectiveness of interagency and intraagency coordination,
			 communication, strategic planning, and decision-making) affected drug
			 shortages?
					(5)How does hoarding
			 affect drug shortages?
					(6)How would
			 incentives alleviate or prevent drug shortages?
					(7)How are healthcare
			 providers, including hospitals and physicians responding to drug shortages, to
			 what extent are such providers able to adjust care effectively to compensate
			 for such shortages, and what impediments exist that hinder provider ability to
			 adjust to such shortages?
					(c)Consultation
			 with stakeholdersIn
			 conducting the study under this section, the Comptroller General shall consult
			 with relevant stakeholders, including physicians, pharmacists, hospitals,
			 patients, drug manufacturers, and other health providers.
				(d)ReportNote
			 later than 18 months after the date of the enactment of this Act, the
			 Comptroller General shall submit a report to the Committee on Energy and
			 Commerce of the House of Representatives and the Committee on Health,
			 Education, Labor, and Pensions of the Senate on the results of the study under
			 this section.
				906.Annual report
			 on drug shortagesNot later
			 than 18 months after the date of the enactment of this Act, and annually
			 thereafter, the Secretary of Health and Human Services shall 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
			 drug shortages that—
				(1)describes the communication between the
			 field investigators of the Food and Drug Administration and the staff of the
			 Center for Drug Evaluation and Research’s Office of Compliance and Drug
			 Shortage Program, including the Food and Drug Administration’s procedures for
			 enabling and ensuring such communication;
				(2)describes the Food
			 and Drug Administration’s efforts to expedite the review of new manufacturing
			 sites, new suppliers, and specification changes to prevent or alleviate a drug
			 shortage;
				(3)describes the coordination between the Food
			 and Drug Administration and the Drug Enforcement Administration on efforts to
			 prevent or alleviate drug shortages;
				(4)identifies the
			 number of, and describes the instances in which the Food and Drug
			 Administration exercised regulatory flexibility and discretion to prevent or
			 alleviate a drug shortage;
				(5)identifies the
			 number of instances in which the Food and Drug Administration asked firms to
			 increase production to prevent or alleviate a shortage;
				(6)identifies the
			 number of notifications submitted to the Secretary under section 506C of the
			 Federal Food, Drug, and Cosmetic Act, as amended by section 901 of this Act,
			 including the percentage of such notifications for a drug that is a sterile
			 injectable;
				(7)describes the Food
			 and Drug Administration’s implementation of section 506D of the Federal Food,
			 Drug, and Cosmetic Act (relating to a drug shortage list), as added by section
			 902 of this Act, and identifies—
					(A)the name of each
			 drug on the list under such section 506D at any point during the period covered
			 by the report;
					(B)the name of each
			 manufacturer of each such drug;
					(C)the reason for the
			 shortage of each such drug; and
					(D)the anticipated
			 or, if known, actual duration of the shortage of each such drug;
					(8)identifies
			 whether, and how, the Food and Drug Administration expedited the review of
			 regulatory submissions to prevent or alleviate shortages, including how the
			 Administration utilized the authority in section 506A(c)(3) of the Federal
			 Food, Drug, and Cosmetic Act, as added by section 904 of this Act;
				(9)identifies the number of certifications
			 submitted under such section 506A(c)(3) and, for each such certification,
			 whether the Food and Drug Administration completed expedited review within 60
			 days as required by subparagraph (B) of such section 506A(c)(3);
				(10)describes the Secretary’s public engagement
			 on drug shortages with stakeholders, including physicians, pharmacists,
			 patients, hospitals, drug manufacturers, and other health providers; and
				(11)contains the Secretary’s plan for
			 addressing drug shortages in the upcoming year, including with respect to the
			 issues described in paragraphs (1) through (10).
				907.Attorney
			 General report on drug shortagesNot later than 6 months after the date of
			 the enactment of this Act, and annually thereafter, the Attorney General shall
			 submit to the Committee on Energy and Commerce of the House of Representatives
			 and the Committee on the Judiciary of the Senate a report on drug shortages
			 that—
				(1)identifies the number of requests received
			 under section 306(h) of the Controlled Substances Act (as added by section 903
			 of this Act), the average review time for such requests, the number of requests
			 granted and denied under such section, and, for each of the requests denied
			 under such section, the basis for such denial;
				(2)describes the
			 coordination between the Drug Enforcement Administration and Food and Drug
			 Administration on efforts to prevent or alleviate drug shortages; and
				(3)identifies drugs
			 containing a controlled substance subject to section 306 of the Controlled
			 Substances Act when such a drug is determined by the Secretary of Health and
			 Human Services to be in shortage.
				908.Hospital repackaging
			 of drugs in shortageChapter V
			 (21 U.S.C. 351 et
			 seq.), as amended by section 902 of this Act, is further
			 amended by inserting after section 506D the following:

					506E.Hospital
				repackaging of drugs in shortage
						(a)DefinitionsIn
				this section:
							(1)DrugThe
				term drug excludes any controlled substance (as such term is
				defined in section 102 of the Controlled Substances Act).
							(2)Health
				systemThe term health system means a collection of
				hospitals that are owned and operated by the same entity and that share access
				to databases with drug order information for their patients.
							(3)RepackageFor
				the purposes of this section only, the term repackage, with
				respect to a drug, means to divide the volume of a drug into smaller amounts in
				order to—
								(A)extend the supply
				of a drug in response to the placement of the drug on a drug shortage list
				described in subsection (b); and
								(B)facilitate access
				to the drug by hospitals within the same health system.
								(b)Exclusion from
				registrationNotwithstanding
				any other provision of this Act, a hospital shall not be considered an
				establishment for which registration is required under section 510 solely
				because it repackages a drug and transfers it to another hospital within the
				same health system in accordance with the conditions in subsection (c)—
							(1)during any period
				in which the drug is listed on the Drug Shortage List of the Food and Drug
				Administration; or
							(2)during the 60-day
				period following any period described in paragraph (1).
							(c)ConditionsSubsection
				(b) shall only apply to a hospital, with respect to the repackaging of a drug
				for transfers to another hospital within the same health system, if the
				following conditions are met:
							(1)Drug for
				intrasystem use onlyIn no case may a drug that has been
				repackaged in accordance with this section be sold or otherwise distributed by
				the health system or a hospital within the system to an entity or individual
				that is not a hospital within such health system.
							(2)Compliance with
				State rulesRepackaging of a drug under this section shall be
				done in compliance with applicable State requirements in which the health
				system is located.
							(d)TerminationThis
				section shall not apply on or after the date on which the Secretary issues
				final guidance that clarifies the policy of the Food and Drug Administration
				regarding hospital pharmacies repackaging and safely transferring repackaged
				drugs to other hospitals within the same health system during a drug
				shortage.
						.

			Passed the House of
			 Representatives May 30, 2012.
			Karen L. Haas,
			Clerk

		June 4, 2012
		 Received; read twice and placed on the
		  calendar