		One Hundred Twelfth Congress of the United States of
		  America
		2d SessionBegun and held at the City of Washington on Tuesday, the third
		day of January, two thousand and twelve
		S. 3187
		IN THE SENATE OF THE UNITED
		  STATES
		AN ACT
		To amend the Federal Food, Drug, and
		  Cosmetic Act to revise and extend the user-fee programs for prescription drugs
		  and medical devices, to establish user-fee programs for generic drugs and
		  biosimilars, and for other purposes.

		1.Short titleThis Act may be cited as the
			 Food and Drug Administration Safety
			 and Innovation Act.
		2.Table of contents; references in
			 Act
			(a)Table of contentsThe table of contents of this Act is as
			 follows:

					Sec. 1. Short
				title.
					Sec. 2. Table of
				contents; references in Act.
					Title I—Fees relating
				to drugs
					Sec. 101. Short
				title; finding.
					Sec. 102. Definitions.
					Sec. 103. Authority
				to assess and use drug fees.
					Sec. 104. Reauthorization; reporting requirements.
					Sec. 105. Sunset
				dates.
					Sec. 106. Effective
				date.
					Sec. 107. Savings
				clause.
					Title II—Fees relating
				to devices
					Sec. 201. Short
				title; findings.
					Sec. 202. Definitions.
					Sec. 203. Authority
				to assess and use device fees.
					Sec. 204. Reauthorization; reporting requirements.
					Sec. 205. Savings
				clause.
					Sec. 206. Effective
				date.
					Sec. 207. Sunset
				clause.
					Sec. 208. Streamlined
				hiring authority to support activities related to the process for the review of
				device applications.
					Title III—Fees relating
				to generic drugs
					Sec. 301. Short
				title.
					Sec. 302. Authority
				to assess and use human generic drug fees.
					Sec. 303. Reauthorization; reporting requirements.
					Sec. 304. Sunset
				dates.
					Sec. 305. Effective
				date.
					Sec. 306. Amendment
				with respect to misbranding.
					Sec. 307. Streamlined
				hiring authority to support activities related to human generic
				drugs.
					Sec. 308. Additional
				reporting requirements.
					Title IV—Fees relating
				to biosimilar biological products
					Sec. 401. Short
				title; finding.
					Sec. 402. Fees
				relating to biosimilar biological products.
					Sec. 403. Reauthorization; reporting requirements.
					Sec. 404. Sunset
				dates.
					Sec. 405. Effective
				date.
					Sec. 406. Savings
				clause.
					Sec. 407. Conforming
				amendment.
					Sec. 408. Additional
				reporting requirements.
					Title V—Pediatric drugs
				and devices
					Sec. 501. Permanence.
					Sec. 502. Written
				requests.
					Sec. 503. Communication with Pediatric Review
				Committee.
					Sec. 504. Access to
				data.
					Sec. 505. Ensuring
				the completion of pediatric studies.
					Sec. 506. Pediatric
				study plans.
					Sec. 507. Reauthorizations.
					Sec. 508. Report.
					Sec. 509. Technical
				amendments.
					Sec. 510. Pediatric
				rare diseases.
					Sec. 511. Staff of
				Office of Pediatric Therapeutics.
					Title VI—Medical device
				regulatory improvements
					Sec. 601. Investigational device exemptions.
					Sec. 602. Clarification of least burdensome
				standard.
					Sec. 603. Agency
				documentation and review of significant decisions.
					Sec. 604. Device
				modifications requiring premarket notification prior to marketing.
					Sec. 605. Program to
				improve the device recall system.
					Sec. 606. Clinical
				holds on investigational device exemptions.
					Sec. 607. Modification of de novo application
				process.
					Sec. 608. Reclassification procedures.
					Sec. 609. Harmonization of device premarket review, inspection,
				and labeling symbols.
					Sec. 610. Participation in international fora.
					Sec. 611. Reauthorization of third-party review.
					Sec. 612. Reauthorization of third-party
				inspection.
					Sec. 613. Humanitarian device exemptions.
					Sec. 614. Unique
				device identifier.
					Sec. 615. Sentinel.
					Sec. 616. Postmarket
				surveillance.
					Sec. 617. Custom
				devices.
					Sec. 618. Health
				information technology.
					Sec. 619. Good
				guidance practices relating to devices.
					Sec. 620. Pediatric
				device consortia.
					Title VII—Drug supply
				chain
					Sec. 701. Registration of domestic drug
				establishments.
					Sec. 702. Registration of foreign establishments.
					Sec. 703. Identification of drug excipient information with
				product listing.
					Sec. 704. Electronic
				system for registration and listing.
					Sec. 705. Risk-based
				inspection frequency.
					Sec. 706. Records for
				inspection.
					Sec. 707. Prohibition
				against delaying, denying, limiting, or refusing inspection.
					Sec. 708. Destruction
				of adulterated, misbranded, or counterfeit drugs offered for
				import.
					Sec. 709. Administrative detention.
					Sec. 710. Exchange of
				information.
					Sec. 711. Enhancing
				the safety and quality of the drug supply.
					Sec. 712. Recognition
				of foreign government inspections.
					Sec. 713. Standards
				for admission of imported drugs.
					Sec. 714. Registration of commercial importers.
					Sec. 715. Notification.
					Sec. 716. Protection
				against intentional adulteration.
					Sec. 717. Penalties
				for counterfeiting drugs.
					Sec. 718. Extraterritorial jurisdiction.
					Title VIII—Generating
				Antibiotic Incentives Now
					Sec. 801. Extension
				of exclusivity period for drugs.
					Sec. 802. Priority
				review.
					Sec. 803. Fast track
				product.
					Sec. 804. Clinical
				trials.
					Sec. 805. Reassessment of qualified infectious disease product
				incentives in 5 years.
					Sec. 806. Guidance on
				pathogen-focused antibacterial drug development.
					Title IX—Drug approval
				and patient access
					Sec. 901. Enhancement
				of accelerated patient access to new medical treatments.
					Sec. 902. Breakthrough therapies.
					Sec. 903. Consultation with external experts on rare diseases,
				targeted therapies, and genetic targeting of treatments.
					Sec. 904. Accessibility of information on prescription drug
				container labels by visually impaired and blind consumers.
					Sec. 905. Risk-benefit framework.
					Sec. 906. Grants and
				Contracts for the Development of Orphan Drugs.
					Sec. 907. Reporting
				of inclusion of demographic subgroups in clinical trials and data analysis in
				applications for drugs, biologics, and devices.
					Sec. 908. Rare
				pediatric disease priority review voucher incentive program.
					Title X—Drug
				shortages
					Sec. 1001. Discontinuance or interruption in the production of
				life-saving drugs.
					Sec. 1002. Annual
				reporting on drug shortages.
					Sec. 1003. Coordination; task force and strategic
				plan.
					Sec. 1004. Drug
				shortage list.
					Sec. 1005. Quotas
				applicable to drugs in shortage.
					Sec. 1006. Attorney
				General report on drug shortages.
					Sec. 1007. Hospital
				repackaging of drugs in shortage.
					Sec. 1008. Study on
				drug shortages.
					Title XI—Other
				provisions
					Subtitle
				A—Reauthorizations
					Sec. 1101. Reauthorization of provision relating to exclusivity
				of certain drugs containing single enantiomers.
					Sec. 1102. Reauthorization of the critical path public-private
				partnerships.
					Subtitle B—Medical
				gas product regulation
					Sec. 1111. Regulation
				of medical gases.
					Sec. 1112. Changes to
				regulations.
					Sec. 1113. Rules of
				construction.
					Subtitle
				C—Miscellaneous provisions
					Sec. 1121. Guidance
				document regarding product promotion using the Internet.
					Sec. 1122. Combating
				prescription drug abuse.
					Sec. 1123. Optimizing
				global clinical trials.
					Sec. 1124. Advancing
				regulatory science to promote public health innovation.
					Sec. 1125. Information technology.
					Sec. 1126. Nanotechnology.
					Sec. 1127. Online
				pharmacy report to Congress.
					Sec. 1128. Report on
				small businesses.
					Sec. 1129. Protections for the commissioned corps of the public
				health service act.
					Sec. 1130. Compliance
				date for rule relating to sunscreen drug products for over-the-counter human
				use.
					Sec. 1131. Strategic
				integrated management plan.
					Sec. 1132. Assessment
				and modification of REMS.
					Sec. 1133. Extension
				of period for first applicant to obtain tentative approval without forfeiting
				180-day-exclusivity period.
					Sec. 1134. Deadline
				for determination on certain petitions.
					Sec. 1135. Final
				agency action relating to petitions and civil actions.
					Sec. 1136. Electronic
				submission of applications.
					Sec. 1137. Patient
				participation in medical product discussions.
					Sec. 1138. Ensuring
				adequate information regarding pharmaceuticals for all populations,
				particularly underrepresented subpopulations, including racial
				subgroups.
					Sec. 1139. Scheduling
				of hydrocodone.
					Sec. 1140. Study on
				Drug Labeling by Electronic Means.
					Sec. 1141. Recommendations on interoperability
				standards.
					Sec. 1142. Conflicts
				of interest.
					Sec. 1143. Notification of FDA intent to regulate
				laboratory-developed tests.
					Subtitle D—Synthetic
				drugs
					Sec. 1151. Short
				title.
					Sec. 1152. Addition
				of synthetic drugs to schedule I of the Controlled Substances Act.
					Sec. 1153. Temporary
				scheduling to avoid imminent hazards to public safety expansion.

			(b)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 each fiscal year or the first
			 business day after the enactment of an appropriations Act providing for the
			 collection and obligation of fees for such fiscal year under this
			 section;
						(D)in paragraph (3)—
						(i)in subparagraph (A)—
							(I)by striking subsection
			 (c)(5) and inserting subsection (c)(4); and
							(II)by striking payable on or before
			 October 1 of each year. and inserting due on the later of the
			 first business day on or after October 1 of each fiscal year or the first
			 business day after the enactment of an appropriations Act providing for the
			 collection and obligation of fees for 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) with a potency described in terms of per 100 mL;
									(ii)the same product as another product
				that—
										(I)was approved under an application filed
				under section 505(b) or 505(j); and
										(II)is not in the list of discontinued products
				compiled under section 505(j)(7);
										(iii)the same product as another product that
				was approved under an abbreviated application filed under section 507 (as in
				effect on the day before the date of enactment of the Food and Drug
				Administration Modernization Act of 1997); or
									(iv)the same product as another product that
				was approved under an abbreviated new drug 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 matter preceding subparagraph (A),
			 by striking fiscal years 2008 through 2012 and inserting
			 fiscal years 2013 through 2017;
						(ii)in subparagraph (A), by striking
			 $392,783,000; and and inserting $693,099,000;;
			 and
						(iii)by striking subparagraph (B) and inserting
			 the following:

								(B)the dollar amount equal to the inflation
				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 paragraph
				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 subject to subparagraph
			 (C), shall be collected and available;
						(ii)in subparagraph (A)(ii), by striking
			 shall only be collected and available and inserting shall
			 be available; and
						(iii)by adding at the end the following new
			 subparagraph:

								(C)Provision for early 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;
									(vii)the number of applications filed for
				orphan-designated products per fiscal year for each review division; and
									(viii)the number of breakthrough designations for
				a fiscal year for each review division.
									(2)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 of the Federal Food,
			 Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective
			 October 1, 2017.
				(b)Reporting requirementsSection 736B of the Federal Food, Drug, and
			 Cosmetic Act (21 U.S.C. 379h–2) shall cease to be effective January 31,
			 2018.
				(c)Previous sunset provision
					(1)In generalSection 106 of the Food and Drug
			 Administration Amendments Act of 2007 (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.
			IIFees relating to devices
			201.Short title; findings
				(a)Short titleThis title 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 amounts
				specifiedFor 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)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 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)by amending paragraph (3) 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 Web site 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 (in effect 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) shall cease
			 to be effective January 31, 2018.
				(b)Previous sunset provision
					(1)In generalSection 217 of the Food and Drug
			 Administration Amendments Act 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), 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 3 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 publish 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 publish 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 publish 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 publish 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
				publish 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
				publish 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 publish 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 Act, 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; or
									(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)Six percent shall be derived from fees
				under subsection (a)(2) (relating to drug master files).
									(B)Twenty-four 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)Fifty-six 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)Fourteen 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 publish 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 a publicly available
				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 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 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 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.
						(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 of the Federal Food,
			 Drug, and Cosmetic Act, as added by section 302 of this Act, shall cease to be
			 effective October 1, 2017.
				(b)Reporting requirementsSection 744C of the Federal Food, Drug, and
			 Cosmetic Act, as added by section 303 of this Act, shall cease to be effective
			 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).
							.
				308.Additional reporting
			 requirementsSubchapter A of
			 chapter VII (21 U.S.C. 371 et seq.), as amended by section 208, is further
			 amended by adding at the end the following:

					715.Reporting requirements
						(a)Generic drugsBeginning with fiscal year 2013 and ending
				after fiscal year 2017, not later than 120 days after the end of each fiscal
				year for which fees are collected under part 7 of subchapter C, the Secretary
				shall prepare and submit to the Committee on Health, Education, Labor, and
				Pensions of the Senate and the Committee on Energy and Commerce of the House of
				Representatives a report concerning, for all applications for approval of a
				generic drug under section 505(j), amendments to such applications, and prior
				approval supplements with respect to such applications filed in the previous
				fiscal year—
							(1)the number of such applications that met
				the goals identified for purposes of part 7 of subchapter C, 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;
							(2)the average total time to decision by the
				Secretary for applications for approval of a generic drug under section 505(j),
				amendments to such applications, and prior approval supplements with respect to
				such applications filed in the previous fiscal year, including the number of
				calendar days spent during the review by the Food and Drug Administration and
				the number of calendar days spent by the sponsor responding to a complete
				response letter;
							(3)the total number of applications under
				section 505(j), amendments to such applications, and prior approval supplements
				with respect to such applications that were pending with the Secretary for more
				than 10 months on the date of enactment of the
				Food and Drug Administration Safety and
				Innovation Act; and
							(4)the number of applications described in
				paragraph (3) on which the Food and Drug Administration took final regulatory
				action in the previous fiscal
				year.
							.
			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 5 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 described 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, 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, 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 of the Federal Food,
			 Drug, and Cosmetic Act, as added by section 402 of this Act, shall cease to be
			 effective October 1, 2017.
				(b)Reporting requirementsSection 744I of the Federal Food, Drug, and
			 Cosmetic Act, as added by section 403 of this Act, shall cease to be effective
			 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).
			408.Additional reporting
			 requirementsSection 715, as
			 added by section 308 of this Act, is amended by adding at the end the
			 following:

					(b)Biosimilar biological products
						(1)In generalBeginning with fiscal year 2014, not later
				than 120 days after the end of each fiscal year for which fees are collected
				under part 8 of subchapter C, the Secretary shall prepare and submit to the
				Committee on Health, Education, Labor, and Pensions of the Senate and the
				Committee on Energy and Commerce of the House of Representatives a report
				concerning—
							(A)the number of applications for approval
				filed under section 351(k) of the Public Health Service Act; and
							(B)the percentage of applications described in
				subparagraph (A) that were approved by the Secretary.
							(2)Additional informationAs part of the performance report described
				in paragraph (1), the Secretary shall include an explanation of how the Food
				and Drug Administration is managing the biological product review program to
				ensure that the user fees collected under part 2 are not used to review an
				application under section 351(k) of the Public Health Service
				Act.
						.
			VPediatric drugs and devices
			501.Permanence
				(a)Pediatric studies of drugsSection 505A (21 U.S.C. 355a) is amended by
			 striking subsection (q) (relating to a sunset).
				(b)Research into pediatric uses for drugs and
			 biological productsSection
			 505B (21 U.S.C. 355c) is amended—
					(1)by striking subsection (m); and
					(2)by redesignating subsection (n) as
			 subsection (m).
					502.Written requests
				(a)In general
					(1)Federal Food, Drug, and Cosmetic
			 ActSubsection (h) of section
			 505A (21 U.S.C. 355a) is amended 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.
							.
					(2)Public Health Service ActSection 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).
					(b)NeonatesSubparagraph (A) of section 505A(d)(1) is
			 amended 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..
				503.Communication with Pediatric Review
			 CommitteeNot later than 1
			 year after the date of enactment of this Act, the Secretary of Health and Human
			 Services (referred to in this title as the Secretary) shall
			 issue internal standard operating procedures that provide for the review by the
			 internal review committee established under section 505C of the Federal Food,
			 Drug, and Cosmetic Act (21 U.S.C. 355d) of any significant modifications to
			 initial pediatric study plans, agreed initial pediatric study plans, and
			 written requests under sections 505A and 505B of the Federal Food, Drug, and
			 Cosmetic Act (21 U.S.C. 355a, 355c). Such internal standard operating
			 procedures shall be made publicly available on the Internet Web site of the
			 Food and Drug Administration.
			504.Access
			 to dataNot later than 3 years
			 after the date of enactment of this Act, the Secretary shall make available to
			 the public, including through posting on the Internet Web site of the Food and
			 Drug Administration, the medical, statistical, and clinical pharmacology
			 reviews of, and corresponding written requests issued to an applicant, sponsor,
			 or holder for, pediatric studies submitted between January 4, 2002, and
			 September 27, 2007, under subsection (b) or (c) of section 505A of the Federal
			 Food, Drug, and Cosmetic Act (21 U.S.C. 355a) for which 6 months of market
			 exclusivity was granted and that resulted in a labeling change. The Secretary
			 shall make public the information described in the preceding sentence in a
			 manner consistent with how the Secretary releases information under section
			 505A(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(k)).
			505.Ensuring the completion of pediatric
			 studies
				(a)Extension of deadline for deferred
			 studiesSection 505B (21
			 U.S.C. 355c) is amended—
					(1)in subsection (a)(3)—
						(A)by redesignating subparagraph (B) as
			 subparagraph (C);
						(B)by inserting after subparagraph (A) the
			 following:

								(B)Deferral extension
									(i)In generalOn the initiative of the Secretary or at
				the request of the applicant, the Secretary may grant an extension of a
				deferral approved under subparagraph (A) for submission of some or all
				assessments required under paragraph (1) if—
										(I)the Secretary determines that the
				conditions described in subclause (II) or (III) of subparagraph (A)(i) continue
				to be met; and
										(II)the applicant submits a new timeline under
				subparagraph (A)(ii)(IV) and any significant updates to the information
				required under subparagraph (A)(ii).
										(ii)Timing and informationIf the deferral extension under this
				subparagraph is requested by the applicant, the applicant shall submit the
				deferral extension request containing the information described in this
				subparagraph not less than 90 days prior to the date that the deferral would
				expire. The Secretary shall respond to such request not later than 45 days
				after the receipt of such letter. If the Secretary grants such an extension,
				the specified date shall be the extended date. The sponsor of the required
				assessment under paragraph (1) shall not be issued a letter described in
				subsection (d) unless the specified or extended date of submission for such
				required studies has passed or if the request for an extension is pending. For
				a deferral that has expired prior to the date of enactment of the
				Food and Drug Administration Safety and
				Innovation Act or that will expire prior to 270 days after the
				date of enactment of such Act, a deferral extension shall be requested by an
				applicant not later than 180 days after the date of enactment of such Act. The
				Secretary shall respond to any such request as soon as practicable, but not
				later than 1 year after the date of enactment of such Act. Nothing in this
				clause shall prevent the Secretary from updating the status of a study or
				studies publicly if components of such study or studies are late or
				delayed.
									;
				and
						(C)in subparagraph (C), as so
			 redesignated—
							(i)in clause (i), by adding at the end the
			 following:

									(III)Projected completion date for pediatric
				studies.
									(IV)The reason or reasons why a deferral or
				deferral extension continues to be
				necessary.
									;
				and
							(ii)by amending clause (ii) to read as
			 follows:

									(ii)Public availabilityNot later than 90 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 Internet 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
							(2)in subsection (f)—
						(A)in the subsection heading, by inserting
			 Deferral
			 Extensions, after Deferrals,;
						(B)in paragraph (1), by inserting ,
			 deferral extension,  after deferral; and
						(C)in paragraph (4)—
							(i)in the paragraph heading, by inserting
			 deferral
			 extensions, after deferrals,; and
							(ii)by inserting , deferral extensions,
			  after deferrals.
							(b)Tracking of extensions; annual
			 informationSection
			 505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) is amended to read as follows:

						(D)aggregated on an annual basis—
							(i)the total number of deferrals and deferral
				extensions requested and granted under this section and, if granted, the
				reasons for each such deferral or deferral extension;
							(ii)the timeline for completion of the
				assessments; and
							(iii)the number of assessments completed and
				pending;
							.
				(c)Action on failure To complete
			 studies
					(1)Issuance of letterSubsection (d) of section 505B (21 U.S.C.
			 355c) is amended to read as follows:

							(d)Submission of assessmentsIf 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), the following shall
				apply:
								(1)Beginning 270 days after the date of
				enactment of the Food and Drug Administration
				Safety and Innovation Act, the Secretary shall issue a
				non-compliance letter to such person informing them of such failure to submit
				or meet the requirements of the applicable subsection. Such letter shall
				require the person to respond in writing within 45 calendar days of issuance of
				such letter. Such response may include the person’s request for a deferral
				extension if applicable. Such letter and the person’s written response to such
				letter shall be made publicly available on the Internet Web site of the Food
				and Drug Administration 60 calendar days after issuance, with redactions for
				any trade secrets and confidential commercial information. If the Secretary
				determines that the letter was issued in error, the requirements of this
				paragraph shall not apply.
								(2)The drug or biological product that is the
				subject of an assessment described in subsection (a)(2), applicable
				requirements in subsection (a)(3), or 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 such failure
				shall not be the basis for a proceeding—
									(A)to withdraw approval for a drug under
				section 505(e); or
									(B)to revoke the license for a biological
				product under section 351 of the Public Health Service
				Act.
									.
					(2)Tracking of letters issuedSubparagraph (D) of section 505B(f)(6) (21
			 U.S.C. 355c(f)(6)), as amended by subsection (b), is further amended—
						(A)in clause (ii), by striking ;
			 and and inserting a semicolon;
						(B)in clause (iii), by adding
			 and at the end; and
						(C)by adding at the end the following:

								(iv)the number of postmarket non-compliance
				letters issued pursuant to subsection (d), and the recipients of such
				letters;
								.
						506.Pediatric study plans
				(a)In generalSubsection (e) of section 505B (21 U.S.C.
			 355c) is amended to read as follows:

						(e)Pediatric study plans
							(1)In generalAn applicant subject to subsection (a)
				shall submit to the Secretary an initial pediatric study plan prior to the
				submission of the assessments described under subsection (a)(2).
							(2)Timing; content; meeting
								(A)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 the
				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.(B)Content of initial planThe initial pediatric study plan shall
				include—
									(i)an outline of the pediatric study or
				studies that the applicant plans to conduct (including, to the extent
				practicable study objectives and design, age groups, relevant endpoints, and
				statistical approach);
									(ii)any request for a deferral, partial waiver,
				or waiver under this section, if applicable, along with any supporting
				information; and
									(iii)other information specified in the
				regulations promulgated under paragraph (7).
									(C)MeetingThe Secretary—
									(i)shall meet with the applicant to discuss
				the initial pediatric study plan as soon as practicable, but not later than 90
				calendar days after the receipt of such plan under subparagraph (A);
									(ii)may determine that a written response to
				the initial pediatric study plan is sufficient to communicate comments on the
				initial pediatric study plan, and that no meeting is necessary; and
									(iii)if the Secretary determines that no meeting
				is necessary, shall so notify the applicant and provide written comments of the
				Secretary as soon as practicable, but not later than 90 calendar days after the
				receipt of the initial pediatric study plan.
									(3)Agreed initial pediatric study
				planNot later than 90
				calendar days following the meeting under paragraph (2)(C)(i) or the receipt of
				a written response from the Secretary under paragraph (2)(C)(iii), the
				applicant shall document agreement on the initial pediatric study plan in a
				submission to the Secretary marked Agreed Initial Pediatric Study
				Plan, and the Secretary shall confirm such agreement to the applicant
				in writing not later than 30 calendar days of receipt of such agreed initial
				pediatric study plan.
							(4)Deferral and waiverIf the agreed initial pediatric study plan
				contains a request from the applicant for a deferral, partial waiver, or waiver
				under this section, the written confirmation under paragraph (3) shall include
				a recommendation from the Secretary as to whether such request meets the
				standards under paragraphs (3) or (4) of subsection (a).
							(5)Amendments to the planAt the initiative of the Secretary or the
				applicant, the agreed initial pediatric study plan may be amended at any time.
				The requirements of paragraph (2)(C) shall apply to any such proposed amendment
				in the same manner and to the same extent as such requirements apply to an
				initial pediatric study plan under paragraph (1). The requirements of
				paragraphs (3) and (4) 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 study plan.
							(6)Internal committeeThe Secretary shall consult the internal
				committee under section 505C on the review of the initial pediatric study plan,
				agreed initial pediatric plan, and any significant amendments to such
				plans.
							(7)Required rulemakingNot later than 1 year after the date of
				enactment of the Food and Drug Administration
				Safety and Innovation Act, the Secretary shall promulgate
				proposed regulations and issue guidance to implement the provisions of this
				subsection.
							.
				(b)Conforming amendmentsSection 505B (21 U.S.C. 355c) is
			 amended—
					(1)by amending subclause (II) of subsection
			 (a)(3)(A)(ii) to read as follows:

							(II)a pediatric study plan as described in
				subsection (e);
							;
				and
					(2)in subsection (f)—
						(A)in the subsection heading, by striking
			 pediatric
			 plans, and inserting pediatric study
			 plans,;
						(B)in paragraph (1), by striking all
			 pediatric plans and inserting initial pediatric study plans,
			 agreed initial pediatric study plans,; and
						(C)in paragraph (4)—
							(i)in the paragraph heading, by striking
			 pediatric
			 plans, and inserting pediatric study plans,;
			 and
							(ii)by striking pediatric plans
			 and inserting initial pediatric study plans, agreed initial pediatric
			 study plans,.
							(c)Effective date
					(1)In generalSubject to paragraph (2), the amendments
			 made by this section shall take effect 180 calendar days after the date of
			 enactment of this Act, irrespective of whether the Secretary has promulgated
			 final regulations to carry out such amendments.
					(2)Rule of constructionParagraph (1) shall not be construed to
			 affect the deadline for promulgation of proposed regulations under section
			 505B(e)(7) of the Federal Food, Drug, and Cosmetic Act, as added by subsection
			 (a) of this section.
					507.Reauthorizations
				(a)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)).
				(b)Pediatric Subcommittee of the Oncologic
			 Drugs Advisory CommitteeSection 15(a)(3) 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 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 for the duration of the operation of the
			 Oncologic Drugs Advisory Committee.
				(c)Humanitarian device exemption
			 extensionSection
			 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
			 360j(m)(6)(A)(iv)) is amended by striking 2012 and inserting
			 2017.
				(d)Program for pediatric study of drugs in
			 PHSASection 409I(e)(1) of
			 the Public Health Service Act (42 U.S.C. 284m(e)(1)) is amended by striking
			 to carry out this section and all that follows through the end
			 of paragraph (1) and inserting to carry out this section, $25,000,000
			 for each of fiscal years 2013 through 2017..
				508.Report
				(a)In generalNot later than four years after the date of
			 enactment of this Act and every five years thereafter, 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, and make publicly available, including through posting on the
			 Internet Web site of the Food and Drug Administration, a report on the
			 implementation of sections 505A and 505B of the Federal Food, Drug, and
			 Cosmetic Act (21 U.S.C. 355a, 355c).
				(b)ContentsEach report under subsection (a) shall
			 include—
					(1)an assessment of the effectiveness of
			 sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act in improving
			 information about pediatric uses for approved drugs and biological products,
			 including the number and type of labeling changes made since the date of
			 enactment of this Act and the importance of such uses in the improvement of the
			 health of children;
					(2)the number of required studies under such
			 section 505B that have not met the initial deadline provided under such section
			 505B, including—
						(A)the number of deferrals and deferral
			 extensions granted and the reasons such extensions were granted;
						(B)the number of waivers and partial waivers
			 granted; and
						(C)the number of letters issued under
			 subsection (d) of such section 505B;
						(3)an assessment of the timeliness and
			 effectiveness of pediatric study planning since the date of enactment of this
			 Act, including the number of initial pediatric study plans not submitted in
			 accordance with the requirements of subsection (e) of such section 505B and any
			 resulting rulemaking;
					(4)the number of written requests issued,
			 accepted, and declined under such 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;
					(5)a description and current status of
			 referrals made under subsection (n) of such section 505A;
					(6)an assessment of the effectiveness of
			 studying biological products in pediatric populations under such sections 505A
			 and 505B and section 409I of the Public Health Service Act (42 U.S.C.
			 284m);
					(7)(A)the efforts made by the Secretary to
			 increase the number of studies conducted in the neonatal population (including
			 efforts made to encourage the conduct of appropriate studies in neonates by
			 companies with products that have sufficient safety and other information to
			 make the conduct of the studies ethical and safe); and
						(B)the results of such efforts;
						(8)(A)the number and importance of drugs and
			 biological products for children with cancer that are being tested as a result
			 of the programs under such sections 505A and 505B and under section 409I of the
			 Public Health Service Act; and
						(B)any recommendations for modifications to
			 such programs that would lead to new and better therapies for children with
			 cancer, including a detailed rationale for each recommendation;
						(9)any recommendations for modification to
			 such programs that would improve pediatric drug research and increase pediatric
			 labeling of drugs and biological products;
					(10)an assessment of the successes of and
			 limitations to studying drugs for rare diseases under such sections 505A and
			 505B; and
					(11)an assessment of the Secretary’s efforts to
			 address the suggestions and options described in any prior report issued by the
			 Comptroller General, Institute of Medicine, or the Secretary, and any
			 subsequent reports, including recommendations therein, regarding the topics
			 addressed in the reports under this section, including with respect to—
						(A)improving public access to information from
			 pediatric studies conducted under such sections 505A and 505B; and
						(B)improving the timeliness of pediatric
			 studies and pediatric study planning under such sections 505A and 505B.
						(c)Stakeholder commentAt least 180 days prior to the submission
			 of each report under subsection (a), 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 report including
			 suggestions for modifications that would improve pediatric drug research and
			 pediatric labeling of drugs and biological products.
				509.Technical amendments
				(a)Pediatric studies of drugs in
			 FFDCASection 505A (21 U.S.C.
			 355a) is amended—
					(1)in subsection (k)(2), by striking
			 subsection (f)(3)(F) and inserting subsection
			 (f)(6)(F);
					(2)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.
								;
						(3)in subsection (n)—
						(A)in the subsection heading, by striking
			 completed and inserting
			 submitted; and
						(B)in paragraph (1)—
							(i)in the matter preceding subparagraph (A),
			 by striking have not been completed and inserting have
			 not been submitted by the date specified in the written request issued or if
			 the applicant or holder does not agree to the request;
							(ii)in subparagraph (A)—
								(I)in the first sentence, by inserting
			 , or for which a period of exclusivity eligible for extension under
			 subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or
			 (m)(3) of section 351 of the Public Health Service Act has not ended
			 after expired; and
								(II)by striking Prior to and all
			 that follows through the period at the end; and
								(iii)in subparagraph (B), by striking no
			 listed patents or has 1 or more listed patents that have expired, and
			 inserting no unexpired listed patents and for which no unexpired periods
			 of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this
			 section or under subsection (m)(2) or (m)(3) of section 351 of the Public
			 Health Service Act apply,; and
							(4)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.
							.
					(b)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); and
						(B)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 and inserting such a;
							(2)in subsection (b)(1), in the matter
			 preceding subparagraph (A), by striking After providing notice
			 and all that follows through studies), the and inserting
			 The;
					(3)in subsection (g)—
						(A)in paragraph (1)(A), by inserting
			 that receives a priority review or 330 days after the date of the
			 submission of an application or supplement that receives a standard
			 review after after the date of the submission of the application
			 or supplement; and
						(B)in paragraph (2), by striking the
			 label of such product and inserting the labeling of such
			 product;
						(4)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,; and
						(5)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.
								.
						(c)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,.
					(d)Program for pediatric studies of
			 drugsSection 409I(c) of the
			 Public Health Service Act (42 U.S.C. 284m(c)) is amended—
					(1)in paragraph (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)there remains no patent listed pursuant to
				section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act, and 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
								;
				and
						(2)in paragraph (2)—
						(A)in the paragraph heading, 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.
						(e)Pediatric subcommittee of the Oncologic
			 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 in paragraph (1)(D), by striking ‘‘section
			 505B(f)’’ and inserting section 505C.
				(f)Foundation of national institutes of
			 healthSection 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)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.
					510.Pediatric rare diseases
				(a)Public
			 meetingNot later than 18
			 months after the date of enactment of this Act, the Secretary shall hold at
			 least one public meeting to discuss ways to encourage and accelerate the
			 development of new therapies for pediatric rare diseases.
				(b)ReportNot later than 180 days after the date of
			 the public meeting under subsection (a), the Secretary shall issue a report
			 that includes a strategic plan for encouraging and accelerating the development
			 of new therapies for treating pediatric rare diseases.
				511.Staff of Office of Pediatric
			 TherapeuticsSection 6 of the
			 Best Pharmaceuticals for Children Act (21 U.S.C. 393a) is amended—
				(1)in subsection (c)—
					(A)in paragraph (1), by striking
			 and at the end;
					(B)by redesignating paragraph (2) as paragraph
			 (4); and
					(C)by inserting after paragraph (1) the
			 following:

							(2)subject to subsection (d), one or more
				additional individuals with necessary expertise in a pediatric subpopulation
				that is, as determined through consideration of the reports and recommendations
				issued by the Institute of Medicine and the Comptroller General of the United
				States, less likely to be studied as a part of a written request issued under
				section 505A of the Federal Food, Drug, and Cosmetic Act or an assessment under
				section 505B of such Act;
							(3)one or more additional individuals with
				expertise in pediatric epidemiology;
				and
							;
				and
					(2)by adding at the end the following:

						(d)Neonatology expertiseFor the 5-year period beginning on the date
				of enactment of this subsection, at least one of the individuals described in
				subsection (c)(2) shall have expertise in
				neonatology.
						.
				VIMedical device regulatory
			 improvements
			601.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.
							.
				602.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.
							.
					603.Agency documentation and review of
			 significant decisionsChapter
			 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 provide a substantive
				summary of 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 substantive summary 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.
								.
			604.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 date of
				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.
							.
				605.Program to improve the device recall
			 systemChapter 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)Termination of recallsThe Secretary shall document the basis for
				the termination by the Food and Drug Administration of a device recall.
						(d)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).
							.
			606.Clinical holds on investigational device
			 exemptionsSection 520(g) (21
			 U.S.C. 360j(g)) is amended by adding at the end the following:

					(8)(A)At any time, the Secretary may prohibit the
				sponsor of an investigation from conducting the investigation (referred to in
				this paragraph as a clinical hold) if the Secretary makes a
				determination described in subparagraph (B). The Secretary shall specify the
				basis for the clinical hold, including the specific information available to
				the Secretary which served as the basis for such clinical hold, and confirm
				such determination in writing.
						(B)For purposes of subparagraph (A), a
				determination described in this subparagraph with respect to a clinical hold is
				a determination that—
							(i)the device involved represents an
				unreasonable risk to the safety of the persons who are the subjects of the
				clinical investigation, taking into account the qualifications of the clinical
				investigators, information about the device, the design of the clinical
				investigation, the condition for which the device is to be investigated, and
				the health status of the subjects involved; or
							(ii)the clinical hold should be issued for such
				other reasons as the Secretary may by regulation establish.
							(C)Any written request to the Secretary from
				the sponsor of an investigation that a clinical hold be removed shall receive a
				decision, in writing and specifying the reasons therefor, within 30 days after
				receipt of such request. Any such request shall include sufficient information
				to support the removal of such clinical
				hold.
						.
			607.Modification of de novo application
			 process
				(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 request submitted under clause (ii)
				if the Secretary identifies a legally marketed device that could provide a
				reasonable basis for review of substantial equivalence under paragraph (1), or
				when the Secretary determines that the device submitted is not of low-moderate
				risk or that general controls would be inadequate to control the risks and
				special controls to mitigate the risks cannot be developed.
							(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) (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).
							.
					608.Reclassification procedures
				(a)Classification changes
					(1)In generalSection 513(e)(1) (21 U.S.C. 360c(e)(1)) is
			 amended to read as follows:

							(e)(1)(A)(i)Based on new information respecting a
				device, the Secretary may, upon the initiative of the Secretary or upon
				petition of an interested person, change the classification of such device, and
				revoke, on account of the change in classification, any regulation or
				requirement in effect under section 514 or 515 with respect to such device, by
				administrative order published in the Federal Register following publication of
				a proposed reclassification order in the Federal Register, a meeting of a
				device classification panel described in subsection (b), and consideration of
				comments to a public docket, notwithstanding subchapter II of chapter 5 of
				title 5, United States Code. The proposed reclassification order published in
				the Federal Register shall set forth the proposed reclassification, and a
				substantive summary of the valid scientific evidence concerning the proposed
				reclassification, including—
											(I)the public health benefit of the use of the
				device, and the nature and, if known, incidence of the risk of the
				device;
											(II)in the case of a reclassification from
				class II to class III, why general controls pursuant to subsection (a)(1)(A)
				and special controls pursuant to subsection (a)(1)(B) together are not
				sufficient to provide a reasonable assurance of safety and effectiveness for
				such device; and
											(III)in the case of reclassification from class
				III to class II, why general controls pursuant to subsection (a)(1)(A) and
				special controls pursuant to subsection (a)(1)(B) together are sufficient to
				provide a reasonable assurance of safety and effectiveness for such
				device.
											(ii)An order under this subsection changing the
				classification of a device from class III to class II may provide that such
				classification shall not take effect until the effective date of a performance
				standard established under section 514 for such device.
										(B)Authority to issue such administrative
				order shall not be delegated below the Director of the Center for Devices and
				Radiological Health, acting in consultation with the
				Commissioner.
									.
					(2)Technical and conforming
			 amendments
						(A)Section 513(e)(2) (21 U.S.C. 360c(e)(2)) is
			 amended by striking regulation promulgated and inserting
			 an order issued.
						(B)Section 514(a)(1) (21 U.S.C. 360d(a)(1)) is
			 amended by striking under a regulation under section 513(e) but such
			 regulation and inserting under an administrative order under
			 section 513(e) (or a regulation promulgated under such section prior to the
			 date of enactment of the Food and Drug
			 Administration Safety and Innovation Act) but such order (or
			 regulation).
						(C)Section 517(a)(1) (21 U.S.C. 360g(a)(1)) is
			 amended by striking or changing the classification of a device to class
			 I and inserting , an administrative order changing the
			 classification of a device to class I,.
						(3)Devices reclassified prior to the date of
			 enactment of this Act
						(A)In generalThe amendments made by this subsection
			 shall have no effect on a regulation promulgated with respect to the
			 classification of a device under section 513(e) of the Federal Food, Drug, and
			 Cosmetic Act prior to the date of enactment of this Act.
						(B)Applicability of other
			 provisionsIn the case of a
			 device reclassified under section 513(e) of the Federal Food, Drug, and
			 Cosmetic Act by regulation prior to the date of enactment of this Act, section
			 517(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g(a)(1))
			 shall apply to such regulation promulgated under section 513(e) of such Act
			 with respect to such device in the same manner such section 517(a)(1) applies
			 to an administrative order issued with respect to a device reclassified after
			 the date of enactment of this Act.
						(b)Devices marketed before May 28,
			 1976
					(1)Premarket approvalSection 515 (21 U.S.C. 360e) is
			 amended—
						(A)in subsection (a), by striking
			 regulation promulgated under subsection (b) and inserting
			 an order issued under subsection (b) (or a regulation promulgated under
			 such subsection prior to the date of enactment of the
			 Food and Drug Administration Safety and
			 Innovation Act);
						(B)in subsection (b)—
							(i)in paragraph (1)—
								(I)in the heading, by striking
			 Regulation and inserting Order; and
								(II)in the matter following subparagraph
			 (B)—
									(aa)by striking by regulation,
			 promulgated in accordance with this subsection and inserting by
			 administrative order following publication of a proposed order in the Federal
			 Register, a meeting of a device classification panel described in section
			 513(b), and consideration of comments from all affected stakeholders, including
			 patients, payors, and providers, notwithstanding subchapter II of chapter 5 of
			 title 5, United States Code; and
									(bb)by adding at the end the following:
			 Authority to issue such administrative order shall not be delegated
			 below the Director of the Center for Devices and Radiological Health, acting in
			 consultation with the Commissioner.;
									(ii)in paragraph (2)—
								(I)by striking subparagraph (B); and
								(II)in subparagraph (A)—
									(aa)by striking (2)(A) A proceeding for
			 the promulgation of a regulation under paragraph (1) respecting a device shall
			 be initiated by the publication in the Federal Register of a notice of proposed
			 rulemaking. Such notice shall contain— and inserting (2) A
			 proposed order required under paragraph (1) shall contain—;
									(bb)by redesignating clauses (i) through (iv)
			 as subparagraphs (A) through (D), respectively;
									(cc)in subparagraph (A), as so redesignated, by
			 striking regulation and inserting order;
			 and
									(dd)in subparagraph (C), as so redesignated, by
			 striking regulation and inserting order;
									(iii)in paragraph (3)—
								(I)by striking proposed
			 regulation each place such term appears and inserting proposed
			 order;
								(II)by striking paragraph (2) and
			 after and inserting paragraph (2),;
								(III)by inserting and a meeting of a
			 device classification panel described in section 513(b), after
			 such proposed regulation and findings,;
								(IV)by striking (A) promulgate such
			 regulation and inserting (A) issue an administrative order under
			 paragraph (1);
								(V)by striking paragraph
			 (2)(A)(ii) and inserting paragraph (2)(B); and
								(VI)by striking promulgation of the
			 regulation and inserting issuance of the administrative
			 order; and
								(iv)by striking paragraph (4); and
							(C)in subsection (i)—
							(i)in paragraph (2)—
								(I)in the matter preceding subparagraph
			 (A)—
									(aa)by striking December 1, 1995
			 and inserting the date that is 2 years after the date of enactment of
			 the Food and Drug Administration Safety and
			 Innovation Act; and
									(bb)by striking publish a regulation in
			 the Federal Register and inserting issue an administrative order
			 following publication of a proposed order in the Federal Register, a meeting of
			 a device classification panel described in section 513(b), and consideration of
			 comments from all affected stakeholders, including patients, payors, and
			 providers, notwithstanding subchapter II of chapter 5 of title 5, United States
			 Code,;
									(II)in subparagraph (B), by striking
			 final regulation has been promulgated under section 515(b) and
			 inserting administrative order has been issued under subsection (b) (or
			 no regulation has been promulgated under such subsection prior to the date of
			 enactment of the Food and Drug Administration
			 Safety and Innovation Act);
								(III)in the matter following subparagraph (B),
			 by striking regulation requires and inserting
			 administrative order issued under this paragraph requires;
			 and
								(IV)by striking the third and fourth sentences;
			 and
								(ii)in paragraph (3)—
								(I)by striking regulation
			 requiring each place such term appears and inserting order
			 requiring; and
								(II)by striking promulgation of a
			 section 515(b) regulation and inserting issuance of an
			 administrative order under subsection (b).
								(2)Technical and conforming
			 amendmentsSection 501(f) (21
			 U.S.C. 351(f)) is amended—
						(A)in subparagraph (1)(A)—
							(i)in subclause (i), by striking a
			 regulation promulgated and inserting an order issued;
			 and
							(ii)in subclause (ii), by striking
			 promulgation of such regulation and inserting issuance of
			 such order;
							(B)in subparagraph (2)(B)—
							(i)by striking a regulation
			 promulgated and inserting an order issued; and
							(ii)by striking promulgation of such
			 regulation and inserting issuance of such order;
			 and
							(C)by adding at the end the following:

								(3)In the case of a device with respect to
				which a regulation was promulgated under section 515(b) prior to the date of
				enactment of the Food and Drug Administration
				Safety and Innovation Act, a reference in this subsection to an
				order issued under section 515(b) shall be deemed to include such
				regulation.
								.
						(3)Approval by regulation prior to the date of
			 enactment of this ActThe
			 amendments made by this subsection shall have no effect on a regulation that
			 was promulgated prior to the date of enactment of this Act requiring that a
			 device have an approval under section 515 of the Federal Food, Drug, and
			 Cosmetic Act (21 U.S.C. 360e) of an application for premarket approval.
					(c)ReportingThe Secretary of Health and Human Services
			 shall annually post on the Internet Web site of the Food and Drug
			 Administration—
					(1)the number and type of class I and class II
			 devices reclassified as class II or class III in the previous calendar year
			 under section 513(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
			 360c(e)(1));
					(2)the number and type of class II and class
			 III devices reclassified as class I or class II in the previous calendar year
			 under such section 513(e)(1); and
					(3)the number and type of devices reclassified
			 in the previous calendar year under section 515 of the Federal Food, Drug, and
			 Cosmetic Act (21 U.S.C. 360e).
					609.Harmonization of device premarket review,
			 inspection, and labeling symbolsParagraph (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.
					.

			610.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.
							.
				611.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.
				612.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.
			613.Humanitarian device exemptions
				(a)In generalSection 520(m) (21 U.S.C. 360j(m)) is
			 amended—
					(1)in paragraph (6)—
						(A)in subparagraph (A)—
							(i)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.
										;
				and
							(ii)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 annual distribution number for such device.
				In this paragraph, the term annual distribution number means the
				number of such devices reasonably needed to treat, diagnose, or cure a
				population of 4,000 individuals in the United States. The Secretary shall
				determine the annual distribution number when the Secretary grants such
				exemption.
									;
				and
							(B)by amending subparagraph (C) to read as
			 follows:

								(C)A
				person may petition the Secretary to modify the annual distribution number
				determined by the Secretary under subparagraph (A)(ii) with respect to a device
				if additional information arises, and the Secretary may modify such annual
				distribution
				number.
								;
						(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
			 section 520(m)(6)(A)(i) (as amended by subsection (a)). If the Secretary of
			 Health and Human Services determines that such subclause (I) or (II) applies
			 with respect to a device, clauses (ii), (iii), and (iv) of subparagraph (A) and
			 subparagraphs (B), (C), (D), and (E) of paragraph (6) of such section 520(m)
			 shall apply to such device, and the Secretary shall determine the annual
			 distribution number for purposes of clause (ii) of such subparagraph (A) when
			 making the determination under this subsection.
				614.Unique device identifierSection 519(f) (21 U.S.C. 360i(f)) is
			 amended—
				(1)by striking The Secretary shall
			 promulgate and inserting Not later than December 31, 2012, the
			 Secretary shall issue proposed; and
				(2)by adding at the end the following:
			 The Secretary shall finalize the proposed regulations not later than 6
			 months after the close of the comment period and shall implement the final
			 regulations with respect to devices that are implantable, life-saving, and life
			 sustaining not later than 2 years after the regulations are finalized, taking
			 into account patient access to medical devices and therapies..
				615.SentinelSection 519 (21 U.S.C. 360i) is amended by
			 adding at the end the following:

					(h)Inclusion of devices in the postmarket risk
				identification and analysis system
						(1)In general
							(A)Application to devicesThe 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.
							(B)ExceptionSubclause (II) of clause (i) of section
				505(k)(3)(C) shall not apply to devices.
							(C)ClarificationWith respect to devices, the private sector
				health-related electronic data provided under section 505(k)(3)(C)(i)(III)(bb)
				may include medical device utilization data, health insurance claims data, and
				procedure and device registries.
							(2)DataIn expanding the system as described in
				paragraph (1)(A), the Secretary shall use relevant data with respect to devices
				cleared under section 510(k) or approved under section 515, including claims
				data, patient survey data, and any other data deemed appropriate by the
				Secretary.
						(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.
						.
			616.Postmarket surveillanceSection 522 (21 U.S.C. 360l) is
			 amended—
				(1)in subsection (a)(1)(A), in the matter
			 preceding clause (i), by inserting , at the time of approval or
			 clearance of a device or at any time thereafter, after by
			 order; and
				(2)in subsection (b)(1), by inserting
			 The manufacturer shall commence surveillance under this section not
			 later than 15 months after the day on which the Secretary issues an order under
			 this section. after the second sentence.
				617.Custom
			 devicesSection 520(b) (21
			 U.S.C. 360j(b)) 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).
						.
			618.Health information technology
				(a)ReportNot 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), acting through the
			 Commissioner of Food and Drugs, and in consultation with the National
			 Coordinator for Health Information Technology and the Chairman of the Federal
			 Communications Commission, shall post on the Internet Web sites of the Food and
			 Drug Administration, the Federal Communications Commission, and the Office of
			 the National Coordinator for Health Information Technology, a report that
			 contains a proposed strategy and recommendations on an appropriate, risk-based
			 regulatory framework pertaining to health information technology, including
			 mobile medical applications, that promotes innovation, protects patient safety,
			 and avoids regulatory duplication.
				(b)Working group
					(1)In generalIn carrying out subsection (a), the
			 Secretary may convene a working group of external stakeholders and experts to
			 provide appropriate input on the strategy and recommendations required for the
			 report under subsection (a).
					(2)RepresentativesIf the Secretary convenes the working group
			 under paragraph (1), the Secretary, 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 determine the
			 number of representatives participating in the working group, and shall, to the
			 extent practicable, ensure that the working group is geographically diverse and
			 includes representatives of patients, consumers, health care providers, startup
			 companies, health plans or other third-party payers, venture capital investors,
			 information technology vendors, health information technology vendors, small
			 businesses, purchasers, employers, and other stakeholders with relevant
			 expertise, as determined by the Secretary.
					619.Good guidance practices relating to
			 devicesSubparagraph (C) of
			 section 701(h)(1) (21 U.S.C. 371(h)(1)) is amended—
				(1)by striking (C) For guidance
			 documents and inserting (C)(i) For guidance documents;
			 and
				(2)by adding at the end the following:

						(ii)With respect to devices, if a notice to
				industry guidance letter, a notice to industry advisory letter, or any similar
				notice sets forth initial interpretations of a regulation or policy or sets
				forth changes in interpretation or policy, such notice shall be treated as a
				guidance document for purposes of this
				subparagraph.
						.
				620.Pediatric device consortia
				(a)In generalSection 305(e) of Pediatric Medical Device
			 Safety and Improvement Act (Public Law 110–85; 42 U.S.C. 282 note)) is amended
			 by striking $6,000,000 for each of fiscal years 2008 through
			 2012 and inserting $5,250,000 for each of fiscal years 2013
			 through 2017.
				(b)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.
					VIIDrug supply chain
			701.Registration of domestic drug
			 establishmentsSection 510 (21
			 U.S.C. 360) is amended—
				(1)in subsection (b)—
					(A)in paragraph (1), by striking On or
			 before and all that follows through the period at the end and inserting
			 the following: “During the period beginning on October 1 and ending on December
			 31 of each year, every person who owns or operates any establishment in any
			 State engaged in the manufacture, preparation, propagation, compounding, or
			 processing of a drug or drugs shall register with the Secretary the name of
			 such person, places of business of such person, all such establishments, the
			 unique facility identifier of each such establishment, and a point of contact
			 e-mail address.; and
					(B)by adding at the end the following:

							(3)The Secretary shall specify the unique
				facility identifier system that shall be used by registrants under paragraph
				(1). The requirement to include a unique facility identifier in a registration
				under paragraph (1) shall not apply until the date that the identifier system
				is specified by the Secretary under the preceding
				sentence.
							;
				and
					(2)in subsection (c), by striking with
			 the Secretary his name, place of business, and such establishment and
			 inserting “with the Secretary—

						(1)with respect to drugs, the information
				described under subsection (b)(1); and
						(2)with respect to devices, the information
				described under subsection
				(b)(2).
						.
				702.Registration of foreign
			 establishments
				(a)Enforcement of registration of foreign
			 establishmentsSection 502(o)
			 (21 U.S.C. 352(o)) is amended by striking in any State.
				(b)Registration of foreign drug
			 establishmentsSection 510(i)
			 (U.S.C. 360(i)) is amended—
					(1)in paragraph (1)—
						(A)by amending the matter preceding
			 subparagraph (A) to read as follows: Every person who owns or operates
			 any establishment within any foreign country engaged in the manufacture,
			 preparation, propagation, compounding, or processing of a drug or device that
			 is imported or offered for import into the United States shall, through
			 electronic means in accordance with the criteria of the
			 Secretary—;
						(B)by amending subparagraph (A) to read as
			 follows:

								(A)upon first engaging in any such activity,
				immediately submit a registration to the Secretary that includes—
									(i)with respect to drugs, the name and place
				of business of such person, all such establishments, the unique facility
				identifier of each such establishment, a point of contact e-mail address, the
				name of the United States agent of each such establishment, the name of each
				importer of such drug in the United States that is known to the establishment,
				and the name of each person who imports or offers for import such drug to the
				United States for purposes of importation; and
									(ii)with respect to devices, the name and place
				of business of the establishment, the name of the United States agent for the
				establishment, the name of each importer of such device in the United States
				that is known to the establishment, and the name of each person who imports or
				offers for import such device to the United States for purposes of importation;
				and
									;
				and
						(C)by amending subparagraph (B) to read as
			 follows:

								(B)each establishment subject to the
				requirements of subparagraph (A) shall thereafter register with the Secretary
				during the period beginning on October 1 and ending on December 31 of each
				year.
								;
				and
						(2)by adding at the end the following:

							(4)The Secretary shall specify the unique
				facility identifier system that shall be used by registrants under paragraph
				(1) with respect to drugs. The requirement to include a unique facility
				identifier in a registration under paragraph (1) with respect to drugs shall
				not apply until the date that the identifier system is specified by the
				Secretary under the preceding
				sentence.
							.
					703.Identification of drug excipient
			 information with product listingSection 510(j) (21 U.S.C. 360(j)) is
			 amended—
				(1)in paragraph (1)—
					(A)in subparagraph (C), by striking ;
			 and and inserting a semicolon;
					(B)in subparagraph (D), by striking the period
			 at the end and inserting ; and; and
					(C)by adding at the end the following:

							(E)in the case of a drug contained in the
				applicable list, the name and place of business of each manufacturer of an
				excipient of the listed drug with which the person listing the drug conducts
				business, including all establishments used in the production of such
				excipient, the unique facility identifier of each such establishment, and a
				point of contact e-mail address for each such excipient
				manufacturer.
							;
				and
					(2)by adding at the end the following:

						(4)The Secretary shall require persons subject
				to this subsection to use, for purposes of this subsection, the unique facility
				identifier systems specified under subsections (b)(3) and (i)(4) with respect
				to drugs. Such requirement shall not apply until the date that the identifier
				system under subsection (b)(3) or (i)(4), as applicable, is specified by the
				Secretary.
						.
				704.Electronic system for registration and
			 listingSection 510(p) (21
			 U.S.C. 360(p)) is amended—
				(1)by striking (p) Registrations and
			 listings and inserting the following:

						(p)Electronic registration and
				listing
							(1)In generalRegistrations and
				listings
							;
				and
				(2)by adding at the end the following:

						(2)Electronic databaseNot later than 2 years after the Secretary
				specifies a unique facility identifier system under subsections (b) and (i),
				the Secretary shall maintain an electronic database, which shall not be subject
				to inspection under subsection (f), populated with the information submitted as
				described under paragraph (1) that—
							(A)enables personnel of the Food and Drug
				Administration to search the database by any field of information submitted in
				a registration described under paragraph (1), or combination of such fields;
				and
							(B)uses the unique facility identifier system
				to link with other relevant databases within the Food and Drug Administration,
				including the database for submission of information under section
				801(r).
							(3)Risk-based information and
				coordinationThe Secretary
				shall ensure the accuracy and coordination of relevant Food and Drug
				Administration databases in order to identify and inform risk-based inspections
				under section
				510(h).
						.
				705.Risk-based inspection
			 frequencySection 510(h) (21
			 U.S.C. 360(h)) is amended to read as follows:

					(h)Inspections
						(1)In generalEvery establishment that is required to be
				registered with the Secretary under this section shall be subject to inspection
				pursuant to section 704.
						(2)Biennial inspections for
				devicesEvery establishment
				described in paragraph (1), in any State, that is engaged in the manufacture,
				propagation, compounding, or processing of a device or devices classified in
				class II or III shall be so inspected by one or more officers or employees duly
				designated by the Secretary, or by persons accredited to conduct inspections
				under section 704(g), at least once in the 2-year period beginning with the
				date of registration of such establishment pursuant to this section and at
				least once in every successive 2-year period thereafter.
						(3)Risk-based schedule for drugsThe Secretary, acting through one or more
				officers or employees duly designated by the Secretary, shall inspect
				establishments described in paragraph (1) that are engaged in the manufacture,
				preparation, propagation, compounding, or processing of a drug or drugs
				(referred to in this subsection as drug establishments) in
				accordance with a risk-based schedule established by the Secretary.
						(4)Risk factorsIn establishing the risk-based scheduled
				under paragraph (3), the Secretary shall inspect establishments according to
				the known safety risks of such establishments, which shall be based on the
				following factors:
							(A)The compliance history of the
				establishment.
							(B)The record, history, and nature of recalls
				linked to the establishment.
							(C)The inherent risk of the drug manufactured,
				prepared, propagated, compounded, or processed at the establishment.
							(D)The inspection frequency and history of the
				establishment, including whether the establishment has been inspected pursuant
				to section 704 within the last 4 years.
							(E)Whether the establishment has been
				inspected by a foreign government or an agency of a foreign government
				recognized under section 809.
							(F)Any other criteria deemed necessary and
				appropriate by the Secretary for purposes of allocating inspection
				resources.
							(5)Effect of statusIn determining the risk associated with an
				establishment for purposes of establishing a risk-based schedule under
				paragraph (3), the Secretary shall not consider whether the drugs manufactured,
				prepared, propagated, compounded, or processed by such establishment are drugs
				described in section 503(b).
						(6)Annual report on inspections of
				establishmentsBeginning in
				2014, not later than February 1 of each year, the Secretary shall make
				available on the Internet Web site of the Food and Drug Administration a report
				regarding—
							(A)(i)the number of domestic and foreign
				establishments registered pursuant to this section in the previous fiscal year;
				and
								(ii)the number of such domestic establishments
				and the number of such foreign establishments that the Secretary inspected in
				the previous fiscal year;
								(B)with respect to establishments that
				manufacture, prepare, propagate, compound, or process an active ingredient of a
				drug, a finished drug product, or an excipient of a drug, the number of each
				such type of establishment; and
							(C)the percentage of the budget of the Food
				and Drug Administration used to fund the inspections described under
				subparagraph
				(A).
							.
			706.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.
						.
			707.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)).
				708.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 may
			 destroy, without the opportunity for export, any drug refused admission under
			 this section, if such drug is valued at an amount that is $2,500 or less (or
			 such higher amount as the Secretary of the Treasury may set by regulation
			 pursuant to section 498(a)(1) of the Tariff Act of 1930 (19 U.S.C. 1498(a)(1))
			 and was not brought into compliance as described under subsection
			 (b)..
				(b)NoticeSubsection (a) of section 801 (21 U.S.C.
			 381), 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 to appear
			 before the Secretary of Health and Human Services and introduce testimony, as
			 described in the first sentence of this subsection, on destruction of a drug
			 under the sixth sentence of this subsection. The regulations shall provide that
			 prior to destruction, appropriate due process is available to the owner or
			 consignee seeking to challenge the decision to destroy the drug. Where the
			 Secretary of Health and Human Services provides notice and an opportunity to
			 appear and introduce testimony on the destruction of a drug, the Secretary of
			 Health and Human Services shall store and, as applicable, dispose of the drug
			 after the issuance of the notice, except that the owner and consignee shall
			 remain liable for costs pursuant to subsection (c). Such process may be
			 combined with the notice and opportunity to appear before the Secretary and
			 introduce testimony, as described in the first sentence of this subsection, as
			 long as appropriate notice is provided to the owner or
			 consignee..
				(c)ApplicabilityThe amendment made by subsection (a) shall
			 apply beginning on the effective date of the regulations promulgated pursuant
			 to the amendment made by subsection (b).
				(d)Regulations
					(1)In generalNot later than 2 years after the date of
			 enactment of this Act, the Secretary of Health and Human Services shall adopt
			 final regulations implementing the amendments made this section.
					(2)ProcedureIn promulgating a regulation implementing
			 the amendments made by this section, the Secretary of Health and Human Services
			 shall—
						(A)issue a notice of proposed rulemaking that
			 includes a copy of the proposed regulation;
						(B)provide a period of not less than 60 days
			 for comments on the proposed regulation; and
						(C)publish the final regulation not less than
			 30 days before the effective date of the regulation.
						(3)RestrictionsNotwithstanding any other provision of law,
			 the Secretary of Health and Human Services shall promulgate regulations
			 implementing the amendments made by this section only as described in paragraph
			 (2).
					709.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)Regulations
					(1)In generalNot later than 2 years after the date of
			 the enactment of this Act, the Secretary of Health and Human Services shall
			 promulgate regulations in accordance with section 304(i) of the Federal Food,
			 Drug, and Cosmetic Act, as added by paragraph (2) of this subsection, 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.
					(2)In generalSection 304 (21 U.S.C. 334) is amended by
			 adding at the end the following:

							(i)Procedures for promulgating
				regulations
								(1)In generalIn promulgating a regulation implementing
				this section, the Secretary shall—
									(A)issue a notice of proposed rulemaking that
				includes the proposed regulation;
									(B)provide a period of not less than 60 days
				for comments on the proposed regulation; and
									(C)publish the final regulation not less than
				30 days before the regulation’s effective date.
									(2)RestrictionsNotwithstanding any other provision of
				Federal law, in implementing this section, the Secretary shall only promulgate
				regulations as described in paragraph
				(1).
								.
					(c)Effective
			 dateThe amendments made by
			 subsection (a) shall not take effect until
			 the Secretary has issued a final regulation under
			 subsection (b).
				710.Exchange of informationSection 708 (21 U.S.C. 379) is
			 amended—
				(1)by striking Confidential
			 Information and all that follows through The
			 Secretary may provide and inserting the following:

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

						(b)Ability To receive and protect confidential
				information obtained from foreign governments
							(1)In generalThe Secretary shall not be required to
				disclose under section 552 of title 5, United States Code (commonly referred to
				as the Freedom of Information Act), or any other provision of
				law, any information relating to drugs obtained from a foreign government
				agency, if—
								(A)the information concerns the inspection of
				a facility, is part of an investigation, alerts the United States to the
				potential need for an investigation, or concerns a drug that has a reasonable
				probability of causing serious adverse health consequences or death to humans
				or animals;
								(B)the information is provided or made
				available to the United States Government voluntarily on the condition that it
				not be released to the public; and
								(C)the information is covered by, and subject
				to, a written agreement between the Secretary and the foreign
				government.
								(2)Time limitationsThe written agreement described in
				paragraph (1)(C) shall specify the time period for which paragraph (1) shall
				apply to the voluntarily disclosed information.  Paragraph (1) shall not apply
				with respect to such information after the date specified in such agreement,
				but all other applicable legal protections, including the provisions of section
				552 of title 5, United States Code, and section 319L(e)(1) of the Public Health
				Service Act, as applicable, shall continue to apply to such information. If no
				date is specified in the written agreement, paragraph (1) shall not apply with
				respect to such information for a period of more than 36 months.
							(3)Disclosures not affectedNothing in this section authorizes any
				official to withhold, or to authorize the withholding of, information from
				Congress or information required to be disclosed pursuant to an order of a
				court of the United States.
							(4)Relation to other lawFor purposes of section 552 of title 5,
				United States Code, this subsection shall be considered a statute described in
				subsection (b)(3)(B) of such section 552.
							(c)Authority To enter into memoranda of
				understanding for purposes of information exchangeThe
				Secretary may enter into written agreements to provide information referenced
				in section 301(j) to foreign governments subject to the following
				criteria:
							(1)CertificationThe Secretary may enter into a written
				agreement to provide information under this subsection to a foreign government
				only if the Secretary has certified such government 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 to provide
				information to the foreign government 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 only the following circumstances:
								(A)Information concerning the inspection of a
				facility may be provided to a foreign government 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 to humans or
				animals.
								(4)Effect of subsectionNothing in this subsection affects the
				ability of the Secretary to enter into any written agreement authorized by
				other provisions of law to share confidential
				information.
							.
				711.Enhancing the safety and quality of the
			 drug supplySection 501 (21
			 U.S.C. 351) is amended by adding at the end the following flush text:

					For purposes of paragraph (a)(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..
			712.Recognition of foreign government
			 inspectionsChapter VIII (21
			 U.S.C. 381 et seq.) is amended by adding at the end the following:

					809.Recognition of foreign government
				inspections
						(a)InspectionThe Secretary—
							(1)may enter into arrangements and agreements
				with a foreign government or an agency of a foreign government to recognize the
				inspection of foreign establishments registered under section 510(i) in order
				to facilitate risk-based inspections in accordance with the schedule
				established in section 510(h)(3);
							(2)may enter into arrangements and agreements
				with a foreign government or an agency of a foreign government under this
				section only with a foreign government or an agency of a foreign government
				that the Secretary has determined as having the capability of conduction
				inspections that meet the applicable requirements of this Act; and
							(3)shall perform such reviews and audits of
				drug safety programs, systems, and standards of a foreign government or agency
				for the foreign government as the Secretary deems necessary to determine that
				the foreign government or agency of the foreign government is capable of
				conducting inspections that meet the applicable requirements of this
				Act.
							(b)Results of inspectionThe results of inspections performed by a
				foreign government or an agency of a foreign government under this section may
				be used as—
							(1)evidence of compliance with section
				501(a)(2)(B) or section 801(r); and
							(2)for any other purposes as determined
				appropriate by the
				Secretary.
							.
			713.Standards for admission of imported
			 drugsSection 801 (21 U.S.C.
			 381) is amended—
				(1)in subsection (o), by striking drug
			 or; and
				(2)by adding at the end the following:

						(r)(1)The Secretary may require, pursuant to the
				regulations promulgated under paragraph (4)(A), as a condition of granting
				admission to a drug imported or offered for import into the United States, that
				the importer electronically submit information demonstrating that the drug
				complies with applicable requirements of this Act.
							(2)The information described under paragraph
				(1) may include—
								(A)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;
								(B)facility information, such as proof of
				registration and the unique facility identifier;
								(C)indication of compliance with current good
				manufacturing practice, testing results, certifications relating to
				satisfactory inspections, and compliance with the country of export
				regulations; and
								(D)any other information deemed necessary and
				appropriate by the Secretary to assess compliance of the article being offered
				for import.
								(3)Information requirements referred to in
				paragraph (2)(C) may, at the discretion of the Secretary, be satisfied—
								(A)through representation by a foreign
				government, if an inspection is conducted by a foreign government using
				standards and practices as determined appropriate by the Secretary;
								(B)through representation by a foreign
				government or an agency of a foreign government recognized under section 809;
				or
								(C)other appropriate documentation or evidence
				as described by the Secretary.
								(4)(A)Not later than 18 months after the date of
				enactment of the Food and Drug Administration
				Safety and Innovation Act, the Secretary shall adopt final
				regulations implementing this subsection. Such requirements shall be
				appropriate for the type of import, such as whether the drug is for import into
				the United States for use in preclinical research or in a clinical
				investigation under an investigational new drug exemption under 505(i).
								(B)In promulgating the regulations under
				subparagraph (A), the Secretary—
									(i)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 and pass a review of internal controls, including sourcing
				of foreign manufacturing inputs, and plant inspections; and
									(ii)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.
										(C)Notwithstanding any other provision of law,
				the Secretary shall promulgate regulations implementing this subsection only as
				described in subparagraph
				(B).
								.
				714.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 713 of this Act, 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)subject to paragraph (4), 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)ProcedureIn promulgating a regulation under
				subparagraph (A), 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 regulation’s effective date.
									(C)RestrictionsNotwithstanding any other provision of
				Federal law, in implementing this subsection, the Secretary shall only
				promulgate regulations as described in subparagraph (B).
								(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)Unique facility identifierThe Secretary shall specify the unique
				facility identifier system that shall be used by registrants under paragraph
				(1). The requirement to include a unique facility identifier in a registration
				under paragraph (1) shall not apply until the date that the identifier system
				is specified by the Secretary under the preceding sentence.
							(5)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)Procedures for promulgating
			 regulations
						(A)In generalIn promulgating a regulation under
			 paragraph (1), 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 regulation’s effective date.
							(B)RestrictionsNotwithstanding any other provision of
			 Federal law, in implementing section 801(s) of the Federal Food, Drug, and
			 Cosmetic Act, as added by
			 subsection (b), the Secretary shall
			 promulgate regulations only as described in subparagraph (A).
						(3)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.
					715.Notification
				(a)Prohibited actsSection 301 (21 U.S.C. 331), as amended by
			 section 714 of this Act, 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 in the United States; 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.
								.
				716.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 adulterates a drug such that the drug
				is adulterated under subsection (a)(1), (b), (c), or (d) of section 501 and has
				a reasonable probability of causing serious adverse health consequences or
				death to humans or animals shall be imprisoned for not more than 20 years or
				fined not more than $1,000,000, or
				both.
					.
			717.Penalties for counterfeiting drugs
				(a)Counterfeit drug penalty
			 enhancement
					(1)OffenseSection 2320(a) of title 18, United States
			 Code, is amended—
						(A)by striking or at the end of
			 paragraph (2);
						(B)by inserting or at the end
			 of paragraph (3);
						(C)by inserting after paragraph (3) the
			 following:

								(4)traffics in a counterfeit
				drug,
								;
				and
						(D)by striking through (3) and
			 inserting through (4).
						(2)PenaltiesSection 2320(b)(3) of title 18, United
			 States Code, is amended—
						(A)in the heading, by inserting
			 and counterfeit
			 drugs after services; and
						(B)by inserting or counterfeit
			 drug after service.
						(3)DefinitionSection 2320(f) of title 18, United States
			 Code, is amended—
						(A)by striking and at the end
			 of paragraph (4);
						(B)by striking the period at the end of
			 paragraph (5) and inserting ; and; and
						(C)by adding at the end the following:

								(6)the term counterfeit drug
				means a drug, as defined by section 201 of the Federal Food, Drug, and Cosmetic
				Act, that uses a counterfeit mark on or in connection with the
				drug.
								.
						(4)Priority given to certain investigations
			 and prosecutionsThe Attorney
			 General shall give increased priority to efforts to investigate and prosecute
			 offenses under section 2320 of title 18, United States Code, that involve
			 counterfeit drugs.
					(b)Sentencing Commission Directive
					(1)Directive to sentencing
			 commissionPursuant to its
			 authority under section 994(p) of title 28, United States Code, and in
			 accordance with this subsection, the United States Sentencing Commission shall
			 review and amend, if appropriate, its guidelines and its policy statements
			 applicable to persons convicted of an offense described in section 2320(a)(4)
			 of title 18, United States Code, as amended by subsection (a), in order to
			 reflect the intent of Congress that such penalties be increased in comparison
			 to those currently provided by the guidelines and policy statements.
					(2)RequirementsIn carrying out this subsection, the
			 Commission shall—
						(A)ensure that the sentencing guidelines and
			 policy statements reflect the intent of Congress that the guidelines and policy
			 statements reflect the serious nature of the offenses described in paragraph
			 (1) and the need for an effective deterrent and appropriate punishment to
			 prevent such offenses;
						(B)consider the extent to which the guidelines
			 may or may not appropriately account for the potential and actual harm to the
			 public resulting from the offense;
						(C)assure reasonable consistency with other
			 relevant directives and with other sentencing guidelines;
						(D)account for any additional aggravating or
			 mitigating circumstances that might justify exceptions to the generally
			 applicable sentencing ranges;
						(E)make any necessary conforming changes to
			 the sentencing guidelines; and
						(F)assure that the guidelines adequately meet
			 the purposes of sentencing as set forth in section 3553(a)(2) of title 18,
			 United States Code.
						718.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.
					.
			VIIIGenerating Antibiotic Incentives
			 Now
			801.Extension of exclusivity period for
			 drugs
				(a)In generalChapter V (21 U.S.C. 351 et seq.) is
			 amended by inserting after section 505D 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 designated as a qualified
				infectious disease product under subsection (d), the 4- and 5-year periods
				described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the
				3-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 7-year
				period described in section 527, as applicable, shall be extended by 5
				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 with respect
				to a product approved under section 505 for a change that results in a new
				indication, route of administration, dosing schedule, dosage form, delivery
				system, delivery device, or strength; or
								(3)a product that does not meet the definition
				of a qualified infectious disease product under subsection (g) based upon its
				approved uses.
								(d)Designation
								(1)In generalThe manufacturer or sponsor of a drug may
				request the Secretary to designate a drug as a qualified infectious disease
				product at any time before the submission of an application under section
				505(b) for such drug. The Secretary shall, not later than 60 days after the
				submission of such a request, determine whether the drug is a qualified
				infectious disease product.
								(2)LimitationExcept as provided in paragraph (3), a
				designation under this subsection shall not be withdrawn for any reason,
				including modifications to the list of qualifying pathogens under subsection
				(f)(2)(C).
								(3)Revocation of designationThe Secretary may revoke a designation of a
				drug as a qualified infectious disease product if the Secretary finds that the
				request for such designation contained an untrue statement of material
				fact.
								(e)Regulations
								(1)In generalNot later than 2 years after the date of
				enactment of the Food and Drug Administration
				Safety and Innovation Act, the Secretary shall adopt final
				regulations implementing this section, including developing the list of
				qualifying pathogens described in subsection (f).
								(2)ProcedureIn promulgating a regulation implementing
				this section, the Secretary shall—
									(A)issue a notice of proposed rulemaking that
				includes the proposed regulation;
									(B)provide a period of not less than 60 days
				for comments on the proposed regulation; and
									(C)publish the final regulation not less than
				30 days before the effective date of the regulation.
									(3)RestrictionsNotwithstanding any other provision of law,
				the Secretary shall promulgate regulations implementing this section only as
				described in paragraph (2), except that the Secretary may issue interim
				guidance for sponsors seeking designation under subsection (d) prior to the
				promulgation of such regulations.
								(4)Designation prior to
				regulationsThe Secretary
				shall designate drugs as qualified infectious disease products under subsection
				(d) prior to the promulgation of regulations under this subsection, if such
				drugs meet the definition of a qualified infectious disease product described
				in subsection (g).
								(f)Qualifying pathogen
								(1)DefinitionIn this section, the term qualifying
				pathogen means a pathogen identified and listed by the Secretary under
				paragraph (2) that has the potential to pose a serious threat to public health,
				such as—
									(A)resistant gram positive pathogens,
				including methicillin-resistant Staphylococcus aureus, vancomycin-resistant
				Staphylococcus aureus, and vancomycin-resistant enterococcus;
									(B)multi-drug resistant gram negative
				bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli
				species;
									(C)multi-drug resistant tuberculosis;
				and
									(D)Clostridium difficile.
									(2)List of qualifying pathogens
									(A)In generalThe Secretary shall establish and maintain
				a list of qualifying pathogens, and shall make public the methodology for
				developing such list.
									(B)ConsiderationsIn establishing and maintaining the list of
				pathogens described under this section, the Secretary shall—
										(i)consider—
											(I)the impact on the public health due to
				drug-resistant organisms in humans;
											(II)the rate of growth of drug-resistant
				organisms in humans;
											(III)the increase in resistance rates in humans;
				and
											(IV)the morbidity and mortality in humans;
				and
											(ii)consult with experts in infectious diseases
				and antibiotic resistance, including the Centers for Disease Control and
				Prevention, the Food and Drug Administration, medical professionals, and the
				clinical research community.
										(C)ReviewEvery 5 years, or more often as needed, the
				Secretary shall review, provide modifications to, and publish the list of
				qualifying pathogens under subparagraph (A) and shall by regulation revise the
				list as necessary, in accordance with subsection (e).
									(g)Qualified infectious disease
				productThe term
				qualified infectious disease product means an antibacterial or
				antifungal drug for human use intended to treat serious or life-threatening
				infections, including those caused by—
								(1)an antibacterial or antifungal resistant
				pathogen, including novel or emerging infectious pathogens; or
								(2)qualifying pathogens listed by the
				Secretary under subsection
				(f).
								.
				(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.
				802.Priority review
				(a)AmendmentChapter V (21 U.S.C. 351 et seq.) is
			 amended by inserting after section 524 the following:

						524A.Priority review for qualified infectious
				disease products
							If the Secretary designates a drug under
				section 505E(d) as a qualified infectious disease product, then the Secretary
				shall give priority review to any application submitted for approval for such
				drug under section
				505(b).
							.
				(b)ApplicationSection 524A of the Federal Food, Drug, and
			 Cosmetic Act, as added by subsection (a), applies only with respect to an
			 application that is submitted under section 505(b) of such Act (21 U.S.C.
			 355(b)) on or after the date of the enactment of this Act.
				803.Fast track productSection 506(a)(1) (21 U.S.C. 356(a)(1)), as
			 amended by section 901(b) of this Act, is amended by inserting , or if
			 the Secretary designates the drug as a qualified infectious disease product
			 under section 505E(d) before the period at the end of the first
			 sentence.
			804.Clinical trials
				(a)Review and revision of guidance
			 documents
					(1)In generalThe Secretary of Health and Human Services
			 (referred to in this section as the Secretary) shall review and,
			 as appropriate, revise not fewer than 3 guidance documents per year, which
			 shall include—
						(A)reviewing the guidance documents of the
			 Food and Drug Administration for the conduct of clinical trials with respect to
			 antibacterial and antifungal drugs; and
						(B)as appropriate, revising such guidance
			 documents to reflect developments in scientific and medical information and
			 technology and to ensure clarity regarding the procedures and requirements for
			 approval of antibacterial and antifungal drugs 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, trial enrollment, data requirements, and appropriate
			 delta values for noninferiority trials.
					(3)Rule of constructionExcept to the extent to which the Secretary
			 makes revisions under paragraph (1)(B), nothing in this section shall be
			 construed to repeal or otherwise effect the guidance documents of the Food and
			 Drug Administration.
					(b)Recommendations for investigations
					(1)RequestThe sponsor of a drug intended to be
			 designated as a qualified infectious disease product may request that the
			 Secretary provide written recommendations for nonclinical and clinical
			 investigations which the Secretary believes may be necessary to be conducted
			 with the drug before such drug may be approved under section 505 of the Federal
			 Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in treating, detecting,
			 preventing, or identifying a qualifying pathogen, as defined in section 505E of
			 such Act.
					(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)Qualified infectious disease
			 productFor purposes of this
			 section, the term qualified infectious disease product has the
			 meaning given such term in section 505E(g) of the Federal Food, Drug, and
			 Cosmetic Act, as added by section 801 of this Act.
				805.Reassessment of qualified infectious
			 disease product incentives in 5 years
				(a)In generalNot later than 5 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, the 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 such section 505E.
						(C)Whether such products address the need for
			 antibacterial and antifungal drugs to treat serious and life-threatening
			 infections.
						(D)A list of qualified infectious disease
			 products with information on the types of exclusivity granted for each product,
			 consistent with the information published under section 505(j)(7)(A)(iii) of
			 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)(A)(iii)).
						(E)The progress made regarding the review and
			 revision of the clinical trial guidance documents required under section 804
			 and the impact such review and revision has had on the review and approval of
			 qualified infectious disease products.
						(F)The Federal contribution, if any, to
			 funding of the clinical trials for each qualified infectious disease product
			 for each phase.
						(2)Recommendations—
						(A)based on the information under 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 801 of this
			 Act; 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.
					(5)A description of the regulatory challenges
			 and impediments to clinical development, approval, and licensure of qualified
			 infectious disease products, and the steps the Secretary has taken and will
			 take to address such challenges and ensure regulatory certainty and
			 predictability with respect to qualified infectious disease products.
					(b)DefinitionFor purposes of this section, the term
			 qualified infectious disease product has the meaning given such
			 term in section 505E(g) of the Federal Food, Drug, and Cosmetic Act, as added
			 by section 801 of this Act.
				806.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.
				IXDrug approval and patient access
			901.Enhancement of accelerated patient access
			 to new medical treatments
				(a)Findings; Sense of Congress
					(1)FindingsCongress finds as follows:
						(A)The Food and Drug Administration (referred
			 to in this section 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 Congress that the Food
			 and Drug Administration 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 approval of drugs for serious or
			 life-Threatening diseases or conditionsSection 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 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) 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 general
									(A)Accelerated approvalThe 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) or section
				351(a) of the Public Health Service Act upon a determination that the product
				has an effect on a surrogate endpoint that is reasonably likely to predict
				clinical benefit, or on 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, rarity, or prevalence of the condition and the
				availability or lack of alternative treatments. The approval described in the
				preceding sentence is referred to in this section as accelerated
				approval.
									(B)EvidenceThe evidence to support that an endpoint is
				reasonably likely to predict clinical benefit under subparagraph (A) may
				include epidemiological, pathophysiological, therapeutic, pharmacologic, or
				other evidence developed using biomarkers, for example, or other scientific
				methods or tools.
									(2)LimitationApproval of a product under this subsection
				may be subject to 1 or both of the following requirements:
									(A)That the sponsor conduct appropriate
				postapproval studies to verify and describe the predicted effect on
				irreversible morbidity or mortality or other clinical benefit.
									(B)That the sponsor submit copies of all
				promotional materials related to the product during the preapproval review
				period and, following approval and for such period thereafter as the Secretary
				determines to be appropriate, at least 30 days prior to dissemination of the
				materials.
									(3)Expedited withdrawal of
				approvalThe Secretary may
				withdraw approval of a product approved under accelerated approval 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
				postapproval study of the drug 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
				significant unmet medical needs exist.
								(e)Construction
								(1)PurposeThe amendments made by the
				Food and Drug Administration Safety and
				Innovation Act to this section are intended to encourage the
				Secretary to utilize innovative and flexible approaches to the assessment of
				products under accelerated approval for treatments for patients with serious or
				life-threatening diseases or conditions and unmet medical needs.
								(2)ConstructionNothing in this section shall be construed
				to alter the standards of evidence under subsection (c) or (d) of section 505
				(including the substantial evidence standard in section 505(d)) of this Act or
				under section 351(a) of the Public Health Service Act. Such sections and
				standards of evidence apply to the review and approval of products under this
				section, including whether a product is safe and effective. Nothing in this
				section alters the ability of the Secretary to rely on evidence that does not
				come from adequate and well-controlled investigations for the purpose of
				determining whether an endpoint is reasonably likely to predict clinical
				benefit as described in subsection
				(b)(1)(B).
								.
				(c)Guidance; amended regulations
					(1)Draft
			 guidanceNot later than 1
			 year 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 to implement the amendments made by this section. In
			 developing such guidance, the Secretary shall specifically consider issues
			 arising under the accelerated approval and fast track processes under section
			 506 of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (b),
			 for drugs designated for a rare disease or condition under section 526 of such
			 Act (21 U.S.C. 360bb) and shall also consider any unique issues associated with
			 very rare diseases.
					(2)Final
			 guidanceNot later than 1
			 year after the issuance of draft guidance under paragraph (1), and after an
			 opportunity for public comment, the Secretary shall—
						(A)issue final guidance; and
						(B)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 amendment made by subsection
			 (b).
						(3)ConsiderationIn developing the guidance under paragraphs
			 (1) and (2)(A) and the amendments under paragraph (2)(B), the Secretary shall
			 consider 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.
					(4)Conforming changesThe Secretary shall issue, as necessary,
			 conforming amendments to the applicable regulations under title 21, Code of
			 Federal Regulations, governing accelerated approval.
					(5)No effect of inaction on
			 requestsThe issuance (or
			 nonissuance) of guidance or conforming regulations implementing the amendment
			 made by subsection (b) 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
			 subsection (b).
					(d)Independent reviewThe Secretary may, in conjunction with
			 other planned reviews, 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 subsection (b), and the impact of such
			 processes on the development and timely availability of innovative treatments
			 for patients suffering from serious or life-threatening conditions. Any such
			 evaluation shall include consultation with regulated industries, patient
			 advocacy and disease research foundations, and relevant academic medical
			 centers.
				902.Breakthrough therapies
				(a)In generalSection 506 (21 U.S.C. 356), as amended by
			 section 901 of this Act, is further amended—
					(1)by redesignating subsections (a) through
			 (c) as subsections (b) through (d), respectively;
					(2)by redesignating subsection (d) as
			 subsection (f);
					(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 nonclinical 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.
										;
				and
					(4)in subsection (f)(1), as so redesignated,
			 by striking applicable to accelerated approval and inserting
			 applicable to breakthrough therapies, accelerated approval,
			 and.
					(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
			 this 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)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).
				903.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 715 of this Act, 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 review
							(1)In generalPrior 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—
								(A)such consultation will—
									(i)facilitate the Secretary’s ability to
				complete the Secretary’s review; and
									(ii)address outstanding deficiencies in the
				application; or
									(B)the sponsor authorized such
				consultation.
								(2)LimitationThe requirements of this subsection shall
				apply only in instances where the consultation is undertaken solely under the
				authority of this section. The requirements of this subsection shall not apply
				to any consultation initiated under any other
				authority.
							.
			904.Accessibility of information on
			 prescription drug container labels by visually impaired and blind
			 consumers
				(a)Establishment of Working Group
					(1)In generalThe Architectural and Transportation
			 Barriers Compliance Board (referred to in this section as the Access
			 Board) shall convene a stakeholder working group (referred to in this
			 section as the working group) to develop best practices on
			 access to information on prescription drug container labels for individuals who
			 are blind or visually impaired.
					(2)MembersThe working group shall be comprised of
			 representatives of national organizations representing blind and visually
			 impaired individuals, national organizations representing the elderly, and
			 industry groups representing stakeholders, including retail, mail-order, and
			 independent community pharmacies, who would be impacted by such best practices.
			 Representation within the working group shall be divided equally between
			 consumer and industry advocates.
					(3)Best practices
						(A)In generalThe working group shall develop, not later
			 than 1 year after the date of the enactment of this Act, best practices for
			 pharmacies to ensure that blind and visually impaired individuals have safe,
			 consistent, reliable, and independent access to the information on prescription
			 drug container labels.
						(B)Public availabilityThe best practices developed under
			 subparagraph (A) may be made publicly available, including through the Internet
			 Web sites of the working group participant organizations, and through other
			 means, in a manner that provides access to interested individuals, including
			 individuals with disabilities.
						(C)LimitationsThe best practices developed under
			 subparagraph (A) shall not be construed as accessibility guidelines or
			 standards of the Access Board, and shall not confer any rights or impose any
			 obligations on working group participants or other persons. Nothing in this
			 section shall be construed to limit or condition any right, obligation, or
			 remedy available under the Americans with Disabilities Act of 1990 (42 U.S.C.
			 12101 et seq.) or any other Federal or State law requiring effective
			 communication, barrier removal, or nondiscrimination on the basis of
			 disability.
						(4)ConsiderationsIn developing and issuing the best
			 practices under paragraph (3)(A), the working group shall consider—
						(A)the use of—
							(i)Braille;
							(ii)auditory means, such as—
								(I)talking bottles that provide
			 audible container label information;
								(II)digital voice recorders attached to the
			 prescription drug container; and
								(III)radio frequency identification tags;
								(iii)enhanced visual means, such as—
								(I)large font labels or large font
			 duplicate labels that are affixed or matched to a prescription
			 drug container;
								(II)high-contrast printing; and
								(III)sans-serif font; and
								(iv)other relevant alternatives as determined
			 by the working group;
							(B)whether there are technical, financial,
			 manpower, or other factors unique to pharmacies with 20 or fewer retail
			 locations which may pose significant challenges to the adoption of the best
			 practices; and
						(C)such other factors as the working group
			 determines to be appropriate.
						(5)Information campaignUpon completion of development of the best
			 practices under subsection (a)(3), the National Council on Disability, in
			 consultation with the working group, shall conduct an informational and
			 educational campaign designed to inform individuals with disabilities,
			 pharmacists, and the public about such best practices.
					(6)FACA waiverThe Federal Advisory Committee Act (5
			 U.S.C. App.) shall not apply to the working group.
					(b)GAO Study
					(1)In generalBeginning 18 months after the completion of
			 the development of best practices under subsection (a)(3)(A), the Comptroller
			 General of the United States shall conduct a review of the extent to which
			 pharmacies are utilizing such best practices, and the extent to which barriers
			 to accessible information on prescription drug container labels for blind and
			 visually impaired individuals continue.
					(2)ReportNot later than September 30, 2016, the
			 Comptroller General of the United States shall submit to Congress a report on
			 the review conducted under paragraph (1). Such report shall include
			 recommendations about how best to reduce the barriers experienced by blind and
			 visually impaired individuals to independently accessing information on
			 prescription drug container labels.
					(c)DefinitionsIn this section—
					(1)the term pharmacy includes a
			 pharmacy that receives prescriptions and dispenses prescription drugs through
			 an Internet Web site or by mail;
					(2)the term prescription drug
			 means a drug subject to section 503(b)(1) of the Federal Food, Drug, and
			 Cosmetic Act (21 U.S.C. 353(b)(1)); and
					(3)the term prescription drug container
			 label means the label with the directions for use that is affixed to the
			 prescription drug container by the pharmacist and dispensed to the
			 consumer.
					905.Risk-benefit frameworkSection 505(d) (21 U.S.C. 355(d)) is amended
			 by adding at the end the following: The Secretary shall implement a
			 structured risk-benefit assessment framework in the new drug approval process
			 to facilitate the balanced consideration of benefits and risks, a consistent
			 and systematic approach to the discussion and regulatory decisionmaking, and
			 the communication of the benefits and risks of new drugs. Nothing in the
			 preceding sentence shall alter the criteria for evaluating an application for
			 premarket approval of a drug..
			906.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.
						.
				907.Reporting of inclusion of demographic
			 subgroups in clinical trials and data analysis in applications for drugs,
			 biologics, and devices
				(a)Report
					(1)In generalNot later than 1 year after the date of
			 enactment of this Act, the Secretary, acting through the Commissioner, shall
			 publish on the Internet Web site of the Food and Drug Administration a report,
			 consistent with the regulations of the Food and Drug Administration pertaining
			 to the protection of sponsors' confidential commercial information as of the
			 date of enactment of this Act, addressing the extent to which clinical trial
			 participation and the inclusion of safety and effectiveness data by demographic
			 subgroups including sex, age, race, and ethnicity, is included in applications
			 submitted to the Food and Drug Administration, and shall provide such
			 publication to Congress.
					(2)Contents of reportThe report described in paragraph (1) shall
			 contain the following:
						(A)A description of existing tools to ensure
			 that data to support demographic analyses are submitted in applications for
			 drugs, biological products, and devices, and that these analyses are conducted
			 by applicants consistent with applicable Food and Drug Administration
			 requirements and Guidance for Industry. The report shall address how the Food
			 and Drug Administration makes available information about differences in safety
			 and effectiveness of medical products according to demographic subgroups, such
			 as sex, age, racial, and ethnic subgroups, to health care providers,
			 researchers, and patients.
						(B)An analysis of the extent to which
			 demographic data subset analyses on sex, age, race, and ethnicity is presented
			 in applications for new drug applications for new molecular entities under
			 section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), in
			 biologics license applications under section 351 of the Public Health Service
			 Act (42 U.S.C. 262), and in premarket approval applications under section 515
			 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) for products
			 approved or licensed by the Food and Drug Administration, consistent with
			 applicable requirements and Guidance for Industry, and consistent with the
			 regulations of the Food and Drug Administration pertaining to the protection of
			 sponsors' confidential commercial information as of the date of enactment of
			 this Act.
						(C)An analysis of the extent to which
			 demographic subgroups, including sex, age, racial, and ethnic subgroups, are
			 represented in clinical studies to support applications for approved or
			 licensed new molecular entities, biological products, and devices.
						(D)An analysis of the extent to which a
			 summary of product safety and effectiveness data by demographic subgroups
			 including sex, age, race, and ethnicity is readily available to the public in a
			 timely manner by means of the product labeling or the Food and Drug
			 Administration's Internet Web site.
						(b)Action plan
					(1)In generalNot later than 1 year after the publication
			 of the report described in subsection (a), the Secretary, acting through the
			 Commissioner, shall publish an action plan on the Internet Web site of the Food
			 and Drug Administration, and provide such publication to Congress.
					(2)Content of action planThe plan described in paragraph (1) shall
			 include—
						(A)recommendations, as appropriate, to improve
			 the completeness and quality of analyses of data on demographic subgroups in
			 summaries of product safety and effectiveness data and in labeling;
						(B)recommendations, as appropriate, on the
			 inclusion of such data, or the lack of availability of such data in
			 labeling;
						(C)recommendations, as appropriate, to
			 otherwise improve the public availability of such data to patients, health care
			 providers, and researchers; and
						(D)a determination with respect to each
			 recommendation identified in subparagraphs (A) through (C) that distinguishes
			 between product types referenced in subsection (a)(2)(B) insofar as the
			 applicability of each such recommendation to each type of product.
						(c)DefinitionsIn this section:
					(1)The term Commissioner means
			 the Commissioner of Food and Drugs.
					(2)The term device has the
			 meaning given such term in section 201(h) of the Federal Food, Drug, and
			 Cosmetic Act (21 U.S.C. 321(h)).
					(3)The term drug has the meaning
			 given such term in section 201(g) of the Federal Food, Drug, and Cosmetic Act
			 (21 U.S.C. 321(g)).
					(4)The term biological product
			 has the meaning given such term in section 351(i) of the Public Health Service
			 Act (42 U.S.C. 262(i)).
					(5)The term Secretary means the
			 Secretary of Health and Human Services.
					908.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 appropriations 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)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.
							(2)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 Internet
				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)NotificationIf, 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 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).
							.
			XDrug shortages
			1001.Discontinuance or interruption in the
			 production of life-saving drugs
				(a)In generalSection 506C (21 U.S.C. 356c) is amended to
			 read as follows:

						506C.Discontinuance or interruption in the
				production of life-saving drugs
							(a)In generalA manufacturer of a drug—
								(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, including any such drug used
				in emergency medical care or during surgery; and
									(2)that is not a radio pharmaceutical drug
				product or any other product as designated by the Secretary,
								shall notify the Secretary, in
				accordance with subsection (b), of a permanent discontinuance in 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 supply of that drug in the
				United States, and the reasons for such discontinuance or interruption.(b)TimingA notice required under 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, through such means as the Secretary deems
				appropriate, 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 506E.
							(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
				Internet 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 Internet 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.
								(g)Expedited inspections and
				reviewsIf, based on
				notifications described in subsection (a) or any other relevant information,
				the Secretary concludes that there is, or is likely to be, a drug shortage of a
				drug described in subsection (a), the Secretary may—
								(1)expedite the review of a supplement to a
				new drug application submitted under section 505(b), an abbreviated new drug
				application submitted under section 505(j), or a supplement to such an
				application submitted under section 505(j) that could help mitigate or prevent
				such shortage; or
								(2)expedite an inspection or reinspection of
				an establishment that could help mitigate or prevent such drug shortage.
								(h)DefinitionsFor purposes of this section—
								(1)the term drug—
									(A)means a drug (as defined in section 201(g))
				that is intended for human use and that is subject to section 503(b)(1);
				and
									(B)does not include biological products (as
				defined in section 351 of the Public Health Service Act), unless otherwise
				provided by the Secretary in the regulations promulgated under subsection
				(i);
									(2)the term drug shortage or
				shortage, with respect to a drug, means a period of time when the
				demand or projected demand for the drug within the United States exceeds the
				supply of the drug; and
								(3)the term meaningful
				disruption—
									(A)means a change in production that is
				reasonably likely to lead to a reduction in the supply of a drug by a
				manufacturer that is more than negligible and affects the ability of the
				manufacturer to fill orders or meet expected demand for its product; and
									(B)does not include interruptions in
				manufacturing 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.
									(i)Regulations
								(1)In generalNot later than 18 months after the date of
				enactment of the Food and Drug Administration
				Safety and Innovation Act, the Secretary shall adopt a final
				regulation implementing this section.
								(2)ContentsSuch regulation shall define, for purposes
				of this section, the terms life-supporting,
				life-sustaining, and intended for use in the prevention or
				treatment of a debilitating disease or condition.
								(3)Inclusion of biological products
									(A)In generalThe Secretary may by regulation apply this
				section to biological products (as defined in section 351 of the Public Health
				Service Act), including plasma products derived from human plasma protein and
				their recombinant analogs, if the Secretary determines such inclusion would
				benefit the public health. Such regulation shall take into account any supply
				reporting programs and shall aim to reduce duplicative notification.
									(B)Rule for vaccinesIf the Secretary applies this section to
				vaccines pursuant to subparagraph (A), the Secretary shall—
										(i)consider whether the notification
				requirement under subsection (a) may be satisfied by submitting a notification
				to the Centers for Disease Control and Prevention under the vaccine shortage
				notification program of such Centers; and
										(ii)explain the determination made by the
				Secretary under clause (i) in the regulation.
										(4)ProcedureIn promulgating a regulation implementing
				this section, the Secretary shall—
									(A)issue a notice of proposed rulemaking that
				includes the proposed regulation;
									(B)provide a period of not less than 60 days
				for comments on the proposed regulation; and
									(C)publish the final regulation not less than
				30 days before the regulation’s effective date.
									(5)RestrictionsNotwithstanding any other provision of
				Federal law, in implementing this section, the Secretary shall only promulgate
				regulations as described in paragraph
				(4).
								.
				(b)Effect of notificationThe submission of a notification to the
			 Secretary of Health and Human Services (referred to in this title as the
			 Secretary) for purposes of complying with the requirement in
			 section 506C(a) of the Federal Food, Drug, and Cosmetic Act (as amended by
			 subsection (a)) shall not be construed—
					(1)as an admission that any product that is
			 the subject of such notification violates any provision of the Federal Food,
			 Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or
					(2)as evidence of an intention to promote or
			 market the product for an indication or use for which the product has not been
			 approved by the Secretary.
					1002.Annual reporting on drug
			 shortagesChapter V (21 U.S.C.
			 351 et seq.) is amended by inserting after section 506C, as amended by section
			 1001 of this Act, the following:

					506C–1.Annual reporting on drug shortages
						(a)Annual reports to CongressNot later than the end of calendar year
				2013, and not later than the end of each calendar year thereafter, 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 on drug shortages that—
							(1)specifies the number of manufacturers that
				submitted a notification to the Secretary under section 506C(a) during such
				calendar year;
							(2)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;
							(3)(A)lists the major actions taken by the
				Secretary to prevent or mitigate the drug shortages described in paragraph
				(7);
								(B)in the list under subparagraph (A),
				includes—
									(i)the number of applications and supplements
				for which the Secretary expedited review under section 506C(g)(1) during such
				calendar year; and
									(ii)the number of establishment inspections or
				reinspections that the Secretary expedited under section 506C(g)(2) during such
				calendar year;
									(4)describes the coordination between the Food
				and Drug Administration and the Drug Enforcement Administration on efforts to
				prevent or alleviate drug shortages;
							(5)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;
							(6)lists the names of manufacturers that were
				issued letters under section 506C(f); and
							(7)specifies the number of drug shortages
				occurring during such calendar year, as identified by the Secretary.
							(b)Trend
				analysisThe Secretary is
				authorized to retain a third party to conduct a study, if the Secretary
				believes such a study would help clarify the causes, trends, or solutions
				related to drug shortages.
						(c)DefinitionIn this section, the term drug
				shortage or shortage has the meaning given such term in
				section
				506C.
						.
			1003.Coordination; task force and strategic
			 planChapter V (21 U.S.C. 351
			 et seq.) is amended by inserting after section 506C–1, as added by section 1002
			 of this Act, the following:

					506D.Coordination; task force and strategic
				plan
						(a)Task force and strategic plan
							(1)In general
								(A)Task ForceAs soon as practicable after the date of
				enactment of the Food and Drug Administration
				Safety and Innovation Act, the Secretary shall establish a task
				force to develop and implement a strategic plan for enhancing the Secretary’s
				response to preventing and mitigating drug shortages.
								(B)Strategic
				planThe strategic plan
				described in subparagraph (A) shall include—
									(i)plans for enhanced interagency and
				intra-agency coordination, communication, and decisionmaking;
									(ii)plans for ensuring that drug shortages are
				considered when the Secretary initiates a regulatory action that could
				precipitate a drug shortage or exacerbate an existing drug shortage;
									(iii)plans for effective communication with
				outside stakeholders, including who the Secretary should alert about potential
				or actual drug shortages, how the communication should occur, and what types of
				information should be shared;
									(iv)plans for considering the impact of drug
				shortages on research and clinical trials; and
									(v)an examination of whether to establish a
				qualified manufacturing partner program, as described in
				subparagraph (C).
									(C)Description of programIn conducting the examination of a
				qualified manufacturing partner program under subparagraph
				(B)(v), the Secretary—
									(i)shall take into account that—
										(I)a qualified manufacturer,
				for purposes of such program, would need to have the capability and capacity to
				supply products determined or anticipated to be in shortage; and
										(II)in examining the capability and capacity to
				supply products in shortage, the qualified manufacturer could
				have a site that manufactures a drug listed under section 506E or have the
				capacity to produce drugs in response to a shortage within a rapid timeframe;
				and
										(ii)shall examine whether incentives are
				necessary to encourage the participation of qualified
				manufacturers in such a program.
									(D)ConsultationIn carrying out this paragraph, the task
				force shall ensure consultation with the appropriate offices within the Food
				and Drug Administration, including the Office of the Commissioner, the Center
				for Drug Evaluation and Research, the Office of Regulatory Affairs, and
				employees within the Department of Health and Human Services with expertise
				regarding drug shortages. The Secretary shall engage external stakeholders and
				experts as appropriate.
								(2)TimingNot later than 1 year after the date of
				enactment of the Food and Drug Administration
				Safety and Innovation Act, the task force shall—
								(A)publish the strategic plan described in
				paragraph (1); and
								(B)submit such plan to Congress.
								(b)CommunicationThe Secretary shall ensure that, prior to
				any enforcement action or issuance of a warning letter that the Secretary
				determines could reasonably be anticipated to lead to a meaningful disruption
				in the supply in the United States of a drug described under section 506C(a),
				there is communication with the appropriate office of the Food and Drug
				Administration with expertise regarding drug shortages regarding whether the
				action or letter could cause, or exacerbate, a shortage of the drug.
						(c)ActionIf the Secretary determines, after the
				communication described in subsection (b), that an enforcement action or a
				warning letter could reasonably cause or exacerbate a shortage of a drug
				described under section 506C(a), then the Secretary shall evaluate the risks
				associated with the impact of such shortage upon patients and those risks
				associated with the violation involved before taking such action or issuing
				such letter, unless there is imminent risk of serious adverse health
				consequences or death to humans.
						(d)Reporting by other entitiesThe Secretary shall identify or establish a
				mechanism by which health care providers and other third-party organizations
				may report to the Secretary evidence of a drug shortage.
						(e)Review and constructionNo determination, finding, action, or
				omission of the Secretary under this section shall—
							(1)be subject to judicial review; or
							(2)be construed to establish a defense to an
				enforcement action by the Secretary.
							(f)SunsetSubsections (a), (b), (c), and (e) shall
				cease to be effective on the date that is 5 years after the date of enactment
				of the Food and Drug Administration Safety and Innovation
				Act.
						.
			1004.Drug shortage listChapter V (21 U.S.C. 351 et seq.) is amended
			 by inserting after section 506D, as added by section 1003 of this Act, the
			 following:

					506E.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, including
				the National Drug Code number for such drug.
							(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) or section 506C(c) 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).
							.
			1005.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
				Internet 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 506E 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.
							.
			1006.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 1005
			 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 to be in shortage.
				1007.Hospital repackaging of drugs in
			 shortageChapter V (21 U.S.C.
			 351 et seq.) is amended by inserting after section 506E, as added by section
			 1004 of this Act, the following:

					506F.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 under section 506E;
				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 under section 506E; 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 transfer 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 of each State in
				which the drug is repackaged and received.
							(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.
						.
			1008.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 a drug shortage over the preceding 3 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)(A)How have regulations, guidance documents,
			 regulatory practices, policies, and other actions of Federal departments and
			 agencies (including the effectiveness of interagency and intra-agency
			 coordination, communication, strategic planning, and decisionmaking), including
			 those used to enforce statutory requirements, affected drug shortages?
						(B)Do any such regulations, guidances,
			 policies, or practices cause, exacerbate, prevent, or mitigate drug
			 shortages?
						(C)How can regulations, guidances, policies,
			 or practices be modified, streamlined, expanded, or discontinued in order to
			 reduce or prevent such drug shortages?
						(D)What effect would the changes described in
			 subparagraph (C) have on the public health?
						(5)How does hoarding affect drug
			 shortages?
					(6)How would incentives alleviate or prevent
			 drug shortages?
					(7)To what extent are health care providers,
			 including hospitals and physicians responding to drug shortages, able to adjust
			 care effectively to compensate for such shortages, and what impediments exist
			 that hinder provider ability to adjust to such shortages?
					(8)(A)Have drug shortages led market participants
			 to stockpile affected drugs or sell such drugs at inflated prices?
						(B)What has been the impact of any such
			 activities described in subparagraph (A) on Federal revenue, and are there any
			 economic factors that have exacerbated or created a market for such
			 activities?
						(C)Is there a need for any additional
			 reporting or enforcement actions to address such activities?
						(9)(A)How have the activities under section 506D
			 of the Federal Food, Drug, and Cosmetic Act (as added by section 1003 of this
			 Act) improved the efforts of the Food and Drug Administration to mitigate and
			 prevent drug shortages?
						(B)Is there a need to continue the task force
			 and strategic plan under such section 506D, or are there any other
			 recommendations to increase communication and coordination inside the Food and
			 Drug Administration, between the Food and Drug Administration and other
			 agencies, and between the Food and Drug Administration and stakeholders?
						(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)ReportNot 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.
				XIOther provisions
			AReauthorizations
				1101.Reauthorization of provision relating to
			 exclusivity of certain drugs containing single enantiomers
					(a)In generalSection 505(u)(4) (21 U.S.C. 355(u)(4)) is
			 amended by striking 2012 and inserting
			 2017.
					(b)AmendmentSection 505(u)(1)(A)(ii)(II) (21 U.S.C.
			 355(u)(1)(A)(ii)(II)) is amended by inserting clinical after
			 any.
					1102.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.
						.
				BMedical gas product regulation
				1111.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 postapproval 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.
							.
				1112.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 1111 of this Act.
						(3)The term Secretary means the
			 Secretary of Health and Human Services, acting through the Commissioner of Food
			 and Drugs.
						1113.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 1111 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.
						CMiscellaneous provisions
				1121.Guidance document regarding product
			 promotion using the InternetNot later than 2 years after the date of
			 enactment of this Act, the Secretary of Health and Human Services shall issue
			 guidance that describes Food and Drug Administration policy regarding the
			 promotion, using the Internet (including social media), of medical products
			 that are regulated by such Administration.
				1122.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), in coordination with other Federal agencies, as
			 appropriate, shall review current Federal initiatives and identify gaps and
			 opportunities with respect to—
						(1)ensuring the safe use of prescription drugs
			 with the potential for abuse; and
						(2)the treatment of prescription drug
			 dependance.
						(b)ReportNot later than 1 year after the date of
			 enactment of this Act, the Secretary shall post on the Department of Health and
			 Human Service’s Internet Web site a report on the findings of the review under
			 subsection (a). Such report shall include findings and 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 provider participation,
			 producing standardized data on adverse events, patient safety, and patient
			 outcomes; and
						(3)how best to develop provider, pharmacist,
			 and patient education tools and a strategy to widely disseminate such tools and
			 assess the efficacy of such tools.
						(c)Guidance on Abuse-Deterrent
			 productsNot later than 6
			 months after the date of enactment of this Act, the Secretary shall promulgate
			 guidance on the development of abuse-deterrent drug products.
					1123.Optimizing global clinical
			 trialsSubchapter E of chapter
			 V (21 U.S.C. 360bbb et seq.), as amended by section 903 of this Act, is further
			 amended by adding at the end the following:

						569A.Optimizing global clinical trials
							(a)In generalThe Secretary shall—
								(1)work with other regulatory authorities of
				similar standing, medical research companies, and international organizations
				to foster and encourage uniform, scientifically driven clinical trial standards
				with respect to medical products around the world; and
								(2)enhance the commitment to provide
				consistent parallel scientific advice to manufacturers seeking simultaneous
				global development of new medical products in order to—
									(A)enhance medical product development;
									(B)facilitate the use of foreign data;
				and
									(C)minimize the need to conduct duplicative
				clinical studies, preclinical studies, or nonclinical studies.
									(b)Medical productIn this section, the term medical
				product means a drug, as defined in subsection (g) of section 201, a
				device, as defined in subsection (h) of such section, or a biological product,
				as defined in section 351(i) of the Public Health Service Act.
							(c)Savings
				clauseNothing in this
				section shall alter the criteria for evaluating the safety or effectiveness of
				a medical product under this Act.
							569B.Use of clinical investigation data from
				outside the United States
							(a)In generalIn determining whether to approve, license,
				or clear a drug or device pursuant to an application submitted under this
				chapter, the Secretary shall accept data from clinical investigations conducted
				outside of the United States, including the European Union, if the applicant
				demonstrates that such data are adequate under applicable standards to support
				approval, licensure, or clearance of the drug or device in the United
				States.
							(b)Notice to sponsorIf the Secretary finds under subsection (a)
				that the data from clinical investigations conducted outside the United States,
				including in the European Union, are inadequate for the purpose of making a
				determination on approval, clearance, or licensure of a drug or device pursuant
				to an application submitted under this chapter, the Secretary shall provide
				written notice to the sponsor of the application of such finding and include
				the rationale for such
				finding.
							.
				1124.Advancing regulatory science to promote
			 public health innovation
					(a)In generalNot later than 1 year after the date of
			 enactment of this Act, the Secretary of Health and Human Services (referred to
			 in this section as the Secretary) shall develop a strategy and
			 implementation plan for advancing regulatory science for medical products in
			 order to promote the public health and advance innovation in regulatory
			 decisionmaking.
					(b)RequirementsThe strategy and implementation plan
			 developed under subsection (a) shall be consistent with the user fee
			 performance goals in the Prescription Drug User Fee Agreement commitment
			 letter, the Generic Drug User Fee Agreement commitment letter, and the
			 Biosimilar User Fee Agreement commitment letter transmitted by the Secretary to
			 Congress on January 13, 2012, and the Medical Device User Fee Agreement
			 commitment letter transmitted by the Secretary to Congress on April 20, 2012,
			 and shall—
						(1)identify a clear vision of the fundamental
			 role of efficient, consistent, and predictable, science-based decisions
			 throughout regulatory decisionmaking of the Food and Drug Administration with
			 respect to medical products;
						(2)identify the regulatory science priorities
			 of the Food and Drug Administration directly related to fulfilling the mission
			 of the agency with respect to decisionmaking concerning medical products and
			 allocation of resources toward such regulatory science priorities;
						(3)identify regulatory and scientific gaps
			 that impede the timely development and review of, and regulatory certainty with
			 respect to, the approval, licensure, or clearance of medical products,
			 including with respect to companion products and new technologies, and
			 facilitating the timely introduction and adoption of new technologies and
			 methodologies in a safe and effective manner;
						(4)identify clear, measurable metrics by which
			 progress on the priorities identified under paragraph (2) and gaps identified
			 under paragraph (3) will be measured by the Food and Drug Administration,
			 including metrics specific to the integration and adoption of advances in
			 regulatory science described in paragraph (5) and improving medical product
			 decisionmaking, in a predictable and science-based manner; and
						(5)set forth how the Food and Drug
			 Administration will ensure that advances in regulatory science for medical
			 products are adopted, as appropriate, on an ongoing basis and in an manner
			 integrated across centers, divisions, and branches of the Food and Drug
			 Administration, including by senior managers and reviewers, including through
			 the—
							(A)development, updating, and consistent
			 application of guidance documents that support medical product decisionmaking;
			 and
							(B)adoption of the tools, methods, and
			 processes under section 566 of the Federal Food, Drug, and Cosmetic Act (21
			 U.S.C. 360bbb–5).
							(c)Performance reportsThe annual performance reports submitted to
			 Congress under sections 736B(a) (as amended by section 104 of this Act),
			 738A(a) (as amended by section 204 of this Act), 744C(a) (as added by section
			 303 of this Act), and 744I(a) (as added by section 403 of this Act) of the
			 Federal Food, Drug, and Cosmetic Act for each of fiscal years 2014 and 2016,
			 shall include a report from the Secretary on the progress made with respect
			 to—
						(1)advancing the regulatory science priorities
			 identified under paragraph (2) of subsection (b) and resolving the gaps
			 identified under paragraph (3) of such subsection, including reporting on
			 specific metrics identified under paragraph (4) of such subsection;
						(2)the integration and adoption of advances in
			 regulatory science as set forth in paragraph (5) of such subsection; and
						(3)the progress made in advancing the
			 regulatory science goals outlined in the Prescription Drug User Fee Agreement
			 commitment letter, the Generic Drug User Fee Agreement commitment letter, and
			 the Biosimilar User Fee Agreement commitment letter transmitted by the
			 Secretary to Congress on January 13, 2012, and the Medical Device User Fee
			 Agreement transmitted by the Secretary to Congress on April 20, 2012.
						(d)Medical productIn this section, the term medical
			 product means a drug, as defined in subsection (g) of section 201 of the
			 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), a device, as defined in
			 subsection (h) of such section, or a biological product, as defined in section
			 351(i) of the Public Health Service Act.
					1125.Information technology
					(a)HHS reportNot later than 1 year after the date of
			 enactment of this Act, the Secretary of Health and Human Services shall—
						(1)report to Congress on—
							(A)the milestones and a completion date for
			 developing and implementing a comprehensive information technology strategic
			 plan to align the information technology systems modernization projects with
			 the strategic goals of the Food and Drug Administration, including
			 results-oriented goals, strategies, milestones, performance measures;
							(B)efforts to finalize and approve a
			 comprehensive inventory of the information technology systems of the Food and
			 Drug Administration that includes information describing each system, such as
			 costs, system function or purpose, and status information, and incorporate use
			 of the system portfolio into the information investment management process of
			 the Food and Drug Administration;
							(C)the ways in which the Food and Drug
			 Administration uses the plan described in subparagraph (A) to guide and
			 coordinate the modernization projects and activities of the Food and Drug
			 Administration, including the interdependencies among projects and activities;
			 and
							(D)the extent to which the Food and Drug
			 Administration has fulfilled or is implementing recommendations of the
			 Government Accountability Office with respect to the Food and Drug
			 Administration and information technology; and
							(2)develop—
							(A)a documented enterprise architecture
			 program management plan that includes the tasks, activities, and timeframes
			 associated with developing and using the architecture and addresses how the
			 enterprise architecture program management will be performed in coordination
			 with other management disciplines, such as organizational strategic planning,
			 capital planning and investment control, and performance management; and
							(B)a skills inventory, needs assessment, gap
			 analysis, and initiatives to address skills gaps as part of a strategic
			 approach to information technology human capital planning.
							(b)GAO reportNot later than January 1, 2016, the
			 Comptroller General of the United States shall issue a report regarding the
			 strategic plan described in subsection (a)(1)(A) and related actions carried
			 out by the Food and Drug Administration. Such report shall assess the progress
			 the Food and Drug Administration has made on—
						(1)the development and implementation of a
			 comprehensive information technology strategic plan, including the
			 results-oriented goals, strategies, milestones, and performance measures
			 identified in subsection (a)(1)(A);
						(2)the effectiveness of the comprehensive
			 information technology strategic plan described in subsection (a)(1)(A),
			 including the results-oriented goals and performance measures; and
						(3)the extent to which the Food and Drug
			 Administration has fulfilled recommendations of the Government Accountability
			 Office with respect to such agency and information technology.
						1126.Nanotechnology
					(a)In generalThe Secretary of Health and Human Services
			 (referred to in this section as the Secretary) shall intensify
			 and expand activities related to enhancing scientific knowledge regarding
			 nanomaterials included or intended for inclusion in products regulated under
			 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or other
			 statutes administered by the Food and Drug Administration, to address issues
			 relevant to the regulation of those products, including the potential
			 toxicology of such nanomaterials, the potential benefit of new therapies
			 derived from nanotechnology, the effects of such nanomaterials on biological
			 systems, and the interaction of such nanomaterials with biological
			 systems.
					(b)ActivitiesIn conducting activities related to
			 nanotechnology, the Secretary may—
						(1)assess scientific literature and data on
			 general nanomaterials interactions with biological systems and on specific
			 nanomaterials of concern to the Food and Drug Administration;
						(2)in cooperation with other Federal agencies,
			 develop and organize information using databases and models that will
			 facilitate the identification of generalized principles and characteristics
			 regarding the behavior of classes of nanomaterials with biological
			 systems;
						(3)promote Food and Drug Administration
			 programs and participate in collaborative efforts, to further the understanding
			 of the science of novel properties of nanomaterials that might contribute to
			 toxicity;
						(4)promote and participate in collaborative
			 efforts to further the understanding of measurement and detection methods for
			 nanomaterials;
						(5)collect, synthesize, interpret, and
			 disseminate scientific information and data related to the interactions of
			 nanomaterials with biological systems;
						(6)build scientific expertise on nanomaterials
			 within the Food and Drug Administration, including field and laboratory
			 expertise, for monitoring the production and presence of nanomaterials in
			 domestic and imported products regulated under this Act;
						(7)ensure ongoing training, as well as
			 dissemination of new information within the centers of the Food and Drug
			 Administration, and more broadly across the Food and Drug Administration, to
			 ensure timely, informed consideration of the most current science pertaining to
			 nanomaterials;
						(8)encourage the Food and Drug Administration
			 to participate in international and national consensus standards activities
			 pertaining to nanomaterials; and
						(9)carry out other activities that the
			 Secretary determines are necessary and consistent with the purposes described
			 in paragraphs (1) through (8).
						1127.Online pharmacy report to
			 CongressNot later than 1 year
			 after the date of enactment of this Act, the Comptroller General of the United
			 States 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 that describes any problems posed by pharmacy Internet
			 Web sites that violate Federal or State law, including—
					(1)the methods by which Internet Web sites are
			 used to sell prescription drugs in violation of Federal or State law or
			 established industry standards;
					(2)the harmful health effects that patients
			 experience when they consume prescription drugs purchased through such pharmacy
			 Internet Web sites;
					(3)efforts by the Federal Government and State
			 and local governments to investigate and prosecute the owners or operators of
			 pharmacy Internet Web sites, to address the threats such Web sites pose, and to
			 protect patients;
					(4)the level of success that Federal, State,
			 and local governments have experienced in investigating and prosecuting such
			 cases;
					(5)whether the law, as in effect on the date
			 of the report, provides sufficient authorities to Federal, State, and local
			 governments to investigate and prosecute the owners and operators of pharmacy
			 Internet Web sites that violate Federal or State law or established industry
			 standards;
					(6)additional authorities that could assist
			 Federal, State, and local governments in investigating and prosecuting the
			 owners and operators of pharmacy Internet Web sites that violate Federal or
			 State law or established industry standards;
					(7)laws, policies, and activities that would
			 educate consumers about how to distinguish pharmacy Internet Web sites that
			 comply with Federal and State laws and established industry standards from
			 those pharmacy Internet Web sites that do not comply with such laws and
			 standards; and
					(8)activities that private sector actors are
			 taking to address the prevalence of illegitimate pharmacy Internet Web sites,
			 and any policies to encourage further activities.
					1128.Report on small businessesNot later than 1 year after the date of
			 enactment of this Act, the Commissioner of Food and Drugs shall submit a report
			 to Congress that includes—
					(1)a listing of and staffing levels of all
			 small business offices at the Food and Drug Administration, including the small
			 business liaison program;
					(2)the status of partnership efforts between
			 the Food and Drug Administration and the Small Business Administration;
					(3)a summary of outreach efforts to small
			 businesses and small business associations, including availability of toll-free
			 telephone help lines;
					(4)with respect to the program under the
			 Orphan Drug Act (Public Law 97–414), the number of applications made by small
			 businesses and number of applications approved for research grants and the
			 number of companies receiving protocol assistance for the development of drugs
			 for rare diseases and disorders;
					(5)the number of small businesses submitting
			 applications and receiving approval for unsolicited grant applications from the
			 Food and Drug Administration;
					(6)the number of small businesses submitting
			 applications and receiving approval for solicited grant applications from the
			 Food and Drug Administration; and
					(7)barriers small businesses encounter in the
			 drug and medical device approval process.
					1129.Protections for the commissioned corps of
			 the public health service act
					(a)In generalSection 221(a) of the Public Health Service
			 Act (42 U.S.C. 213a(a)) is amended by adding at the end the following:

							(18)Section 1034, Protected Communications;
				Prohibition of Retaliatory Personnel
				Actions.
							.
					(b)Conforming amendmentSection 221(b) of the Public Health Service
			 Act (42 U.S.C. 213a(b)) is amended by adding at the end the following:
			 For purposes of paragraph (18) of subsection (a), the term
			 Inspector General in section 1034 of such title 10 shall mean the
			 Inspector General of the Department of Health and Human
			 Services..
					1130.Compliance date for rule relating to
			 sunscreen drug products for over-the-counter human useIn accordance with the final rule issued by
			 the Commissioner of Food and Drug entitled Labeling and Effectiveness
			 Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of
			 Compliance Dates (77 Fed. Reg. 27591 (May 11, 2012)), a product subject
			 to the final rule issued by the Commissioner entitled Labeling and
			 Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human
			 Use (76 Fed. Reg. 35620 (June 17, 2011)), shall comply with such rule
			 not later than—
					(1)December 17, 2013, for products subject to
			 such rule with annual sales of less than $25,000 and
					(2)December 17, 2012, for all other products
			 subject to such rule.
					1131.Strategic integrated management
			 planNot later than 1 year
			 after the date of enactment of this Act, the Secretary of Health and Human
			 Services shall submit to Congress a strategic integrated management plan for
			 the Center for Drug Evaluation and Research, the Center for Biologics
			 Evaluation and Research, and the Center for Devices and Radiological Health.
			 Such strategic management plan shall—
					(1)identify strategic institutional goals,
			 priorities, and mechanisms to improve efficiency, for the Center for Drug
			 Evaluation and Research, the Center for Biologics Evaluation and Research, and
			 the Center for Devices and Radiological Health;
					(2)describe the actions the Secretary will
			 take to recruit, retain, train, and continue to develop the workforce at the
			 Center for Drug Evaluation and Research, the Center for Biologics Evaluation
			 and Research, and the Center for Devices and Radiological Health to fulfill the
			 public health mission of the Food and Drug Administration; and
					(3)identify results-oriented, outcome-based
			 measures that the Secretary will use to measure the progress of achieving the
			 strategic goals, priorities, and mechanisms identified under paragraph (1) and
			 the effectiveness of the actions identified under paragraph (2), including
			 metrics to ensure that managers and reviewers of the Center for Drug Evaluation
			 and Research, the Center for Biologics Evaluation and Research, and the Center
			 for Devices and Radiological Health are familiar with and appropriately and
			 consistently apply the requirements under the Federal Food, Drug, and Cosmetic
			 Act (21 U.S.C. 301 et seq.), including new requirements under parts 2, 3, 7,
			 and 8 of subchapter C of title VII of the Federal Food, Drug, and Cosmetic Act
			 (21 U.S.C. 379f et seq.).
					1132.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.
					1133.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, 2015, 40
			 months; and
							(B)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)).
					1134.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.
					1135.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) and inserting subsection (b)(2)
			 or (j) of this section or section 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;
						(3)in paragraph (4)—
						(A)by redesignating subparagraphs (A) and (B)
			 as clauses (i) and (ii), respectively, and moving such clauses, as so
			 redesignated, 2 ems to the right;
						(B)by striking This subsection does not
			 apply to— and inserting the following:

								(A)This subsection does not apply
				to—
								;
				and
						(C)by adding at the end the following:

								(B)Paragraph (2) does not apply to a petition
				addressing issues concerning an application submitted pursuant to section
				351(k) of the Public Health Service
				Act.
								;
				and
						(4)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.
					1136.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, presubmissions 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 presubmissions or submissions, shall include an
				electronic copy of such presubmissions 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.
									.
				1137.Patient participation in medical product
			 discussionsSubchapter E of
			 chapter V (21 U.S.C. 360bbb et seq.), as amended by section 1123 of this Act,
			 is further amended by adding at the end the following:

						569C.Patient participation in medical product
				discussion
							(a)In generalThe Secretary shall develop and implement
				strategies to solicit the views of patients during the medical product
				development process and consider the perspectives of patients during regulatory
				discussions, including by—
								(1)fostering participation of a patient
				representative who may serve as a special government employee in appropriate
				agency meetings with medical product sponsors and investigators; and
								(2)exploring means to provide for
				identification of patient representatives who do not have any, or have minimal,
				financial interests in the medical products industry.
								(b)Protection of proprietary
				informationNothing in this
				section shall be construed to alter the protections offered by laws,
				regulations, or 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 laws,
				regulations, or policies would apply to consultation with individuals and
				organizations prior to the date of enactment of this section.
							(c)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.
							(d)No right or obligationNothing 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. Nothing 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. Nothing in this section is intended to increase the number
				of review cycles as in effect before the date of enactment of this
				section.
							(e)Financial interestIn this section, the term financial
				interest means a financial interest under section 208(a) of title 18,
				United States
				Code.
							.
				1138.Ensuring adequate information regarding
			 pharmaceuticals for all populations, particularly underrepresented
			 subpopulations, including racial subgroups
					(a)Communication planThe Secretary of Health and Human Services
			 (referred to in this section as the Secretary), acting through
			 the Commissioner of Food and Drugs, shall review and modify, as necessary, the
			 Food and Drug Administration’s communication plan to inform and educate health
			 care providers and patients on the benefits and risks of medical products, with
			 particular focus on underrepresented subpopulations, including racial
			 subgroups.
					(b)ContentThe communication plan described under
			 subsection (a)—
						(1)shall take into account—
							(A)the goals and principles set forth in the
			 Strategic Action Plan to Reduce Racial and Ethnic Health Disparities issued by
			 the Department of Health and Human Services;
							(B)the nature of the medical product;
			 and
							(C)health and disease information available
			 from other agencies within such Department, as well as any new means of
			 communicating health and safety benefits and risks related to medical
			 products;
							(2)taking into account the nature of the
			 medical product, shall address the best strategy for communicating safety
			 alerts, labeled indications for the medical products, changes to the label or
			 labeling of medical products (including black-box warnings, health advisories,
			 health and safety benefits and risks), particular actions to be taken by health
			 care professionals and patients, any information identifying particular
			 subpopulations, and any other relevant information as determined appropriate to
			 enhance communication, including varied means of electronic communication;
			 and
						(3)shall include a process for implementation
			 of any improvements or other modifications determined to be necessary.
						(c)Issuance and posting of communication
			 plan
						(1)Communication planNot later than 1 year after the date of
			 enactment of this Act, the Secretary, acting through the Commissioner of Food
			 and Drugs, shall issue the communication plan described under this
			 section.
						(2)Posting of communication plan on the Office
			 of Minority Health Web siteThe Secretary, acting through the
			 Commissioner of Food and Drugs, shall publicly post the communication plan on
			 the Internet Web site of the Office of Minority Health of the Food and Drug
			 Administration, and provide links to any other appropriate Internet Web site,
			 and seek public comment on the communication plan.
						1139.Scheduling of hydrocodone
					(a)In generalNot later than 60 days after the date of
			 enactment of this Act, if practicable, the Secretary of Health and Human
			 Services (referred to in this section as the Secretary) shall
			 hold a public meeting to solicit advice and recommendations to assist in
			 conducting a scientific and medical evaluation in connection with a scheduling
			 recommendation to the Drug Enforcement Administration regarding drug products
			 containing hydrocodone, combined with other analgesics or as an
			 antitussive.
					(b)Stakeholder inputIn conducting the evaluation under
			 subsection (a), the Secretary shall solicit input from a variety of
			 stakeholders including patients, health care providers, harm prevention
			 experts, the National Institute on Drug Abuse, the Centers for Disease Control
			 and Prevention, and the Drug Enforcement Administration regarding the health
			 benefits and risks, including the potential for abuse and the impact of
			 up-scheduling of these products.
					(c)TranscriptThe transcript of any public meeting
			 conducted pursuant to this section shall be published on the Internet Web site
			 of the Food and Drug Administration.
					1140.Study on Drug Labeling by Electronic
			 Means
					(a)StudyThe Comptroller General of the United
			 States shall conduct a study on the benefits and efficiencies of electronic
			 patient labeling of prescription drugs, as a complete or partial substitute for
			 patient labeling in paper form. The study shall address the implementation
			 costs to the different levels of the distribution system, logistical barriers
			 to utilizing a system of electronic patient labeling, and any anticipated
			 public health impact of movement to electronic labeling.
					(b)ReportNot later than 1 year after the date of
			 enactment of this Act, the Comptroller General shall submit to Congress a
			 report on the results of the study under subsection (a).
					1141.Recommendations on interoperability
			 standards
					(a)In generalThe Secretary of Health and Human Services
			 may facilitate, and, as appropriate, may consult with the Attorney General to
			 facilitate, the development of recommendations on interoperability standards to
			 inform and facilitate the exchange of prescription drug information across
			 State lines by States receiving grant funds under—
						(1)the Harold Rogers Prescription Drug
			 Monitoring Program established under the Departments of Commerce, Justice, and
			 State, the Judiciary, and Related Agencies Appropriations Act, 2002 (Public Law
			 107–77; 115 Stat. 748); and
						(2)the Controlled Substance Monitoring Program
			 established under section 399O of the Public Health Service Act (42 U.S.C.
			 280g–3).
						(b)RequirementsThe Secretary of Health and Human Services
			 shall consider the following in facilitating the development of recommendations
			 on interoperability of prescription drug monitoring programs under subsection
			 (a)—
						(1)open standards that are freely available,
			 without cost and without restriction, in order to promote broad
			 implementation;
						(2)the use of exchange intermediaries, or
			 hubs, as necessary to facilitate interstate interoperability by accommodating
			 State-to-hub, hub-to-hub, and direct State-to-State communication;
						(3)the support of transmissions that are fully
			 secured as required, using industry standard methods of encryption, to ensure
			 that protected health information and personally identifiable information are
			 not compromised at any point during such transmission;
						(4)access control methodologies to share
			 protected information solely in accordance with State laws and regulations;
			 and
						(5)consider model interoperability standards
			 developed by the Alliance of States with Prescription Monitoring
			 Programs.
						(c)Report
						(1)In generalNot later than 1 year 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 enhancing the interoperability of State prescription drug monitoring
			 programs with other technologies and databases used for detecting and reducing
			 fraud, diversion, and abuse of prescription drugs.
						(2)ContentsThe report required under paragraph (1)
			 shall include—
							(A)an assessment of legal, technical, fiscal,
			 privacy, or security challenges that have an impact on interoperability;
							(B)a discussion of how State prescription drug
			 monitoring programs could increase the production and distribution of
			 unsolicited reports to prescribers and dispensers of prescription drugs, law
			 enforcement officials, and health professional licensing agencies, including
			 the enhancement of such reporting through interoperability with other States
			 and relevant technology and databases;
							(C)any recommendations for addressing
			 challenges that impact interoperability of State prescription drug monitoring
			 programs in order to reduce fraud, diversion, and abuse of prescription drugs;
			 and
							(D)an assessment of the extent to which
			 providers use prescription drug management programs in delivering care and
			 preventing prescription drug abuse.
							1142.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 Web
				site 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 Web site 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.
									;
						(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.
								;
				and
						(5)by adding at the end the following:

								(g)Guidance on reported disclosed financial
				interest or involvementThe
				Secretary shall issue guidance that describes how the Secretary reviews the
				financial interests and involvement of advisory committee members that are
				disclosed under subsection (c) but that the Secretary determines not to meet
				the definition of a disqualifying interest under section 208 of title 18,
				United States Code for the purposes of participating in a particular
				matter.
								.

						(b)ApplicabilityThe amendments made by subsection (a) apply
			 beginning on October 1, 2012.
					1143.Notification of FDA intent to regulate
			 laboratory-developed tests
					(a)In generalThe 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.
						(b)SunsetSubsection (a) shall cease to have force or
			 effect on the date that is 5 years after the date of enactment of this
			 Act.
					DSynthetic drugs
				1151.Short titleThis subtitle may be cited as the
			 Synthetic Drug Abuse Prevention Act of
			 2012 .
				1152.Addition of synthetic drugs to schedule I
			 of the Controlled Substances Act
					(a)Cannabimimetic agentsSchedule I, as set forth in section 202(c)
			 of the Controlled Substances Act (21 U.S.C. 812(c)) is amended by adding at the
			 end the following:

							(d)(1)Unless specifically exempted or unless
				listed in another schedule, any material, compound, mixture, or preparation
				which contains any quantity of cannabimimetic agents, or which contains their
				salts, isomers, and salts of isomers whenever the existence of such salts,
				isomers, and salts of isomers is possible within the specific chemical
				designation.
								(2)In paragraph (1):
									(A)The term cannabimimetic
				agents means any substance that is a cannabinoid receptor type 1 (CB1
				receptor) agonist as demonstrated by binding studies and functional assays
				within any of the following structural classes:
										(i)2-(3-hydroxycyclohexyl)phenol with
				substitution at the 5-position of the phenolic ring by alkyl or alkenyl,
				whether or not substituted on the cyclohexyl ring to any extent.
										(ii)3-(1-naphthoyl)indole or
				3-(1-naphthylmethane)indole by substitution at the nitrogen atom of the indole
				ring, whether or not further substituted on the indole ring to any extent,
				whether or not substituted on the naphthoyl or naphthyl ring to any
				extent.
										(iii)3-(1-naphthoyl)pyrrole by substitution at
				the nitrogen atom of the pyrrole ring, whether or not further substituted in
				the pyrrole ring to any extent, whether or not substituted on the naphthoyl
				ring to any extent.
										(iv)1-(1-naphthylmethylene)indene by
				substitution of the 3-position of the indene ring, whether or not further
				substituted in the indene ring to any extent, whether or not substituted on the
				naphthyl ring to any extent.
										(v)3-phenylacetylindole or 3-benzoylindole by
				substitution at the nitrogen atom of the indole ring, whether or not further
				substituted in the indole ring to any extent, whether or not substituted on the
				phenyl ring to any extent.
										(B)Such term includes—
										(i)5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
				(CP–47,497);
										(ii)5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
				(cannabicyclohexanol or CP–47,497 C8-homolog);
										(iii)1-pentyl-3-(1-naphthoyl)indole (JWH–018 and
				AM678);
										(iv)1-butyl-3-(1-naphthoyl)indole
				(JWH–073);
										(v)1-hexyl-3-(1-naphthoyl)indole
				(JWH–019);
										(vi)1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole
				(JWH–200);
										(vii)1-pentyl-3-(2-methoxyphenylacetyl)indole
				(JWH–250);
										(viii)1-pentyl-3-[1-(4-methoxynaphthoyl)]indole
				(JWH–081);
										(ix)1-pentyl-3-(4-methyl-1-naphthoyl)indole
				(JWH–122);
										(x)1-pentyl-3-(4-chloro-1-naphthoyl)indole
				(JWH–398);
										(xi)1-(5-fluoropentyl)-3-(1-naphthoyl)indole
				(AM2201);
										(xii)1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole
				(AM694);
										(xiii)1-pentyl-3-[(4-methoxy)-benzoyl]indole
				(SR–19 and RCS–4);
										(xiv)1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole
				(SR–18 and RCS–8); and
										(xv)1-pentyl-3-(2-chlorophenylacetyl)indole
				(JWH–203).
										.
					(b)Other drugsSchedule I of section 202(c) of the
			 Controlled Substances Act (21 U.S.C. 812(c)) is amended in subsection (c) by
			 adding at the end the following:

							(18)4-methylmethcathinone (Mephedrone).
							(19)3,4-methylenedioxypyrovalerone
				(MDPV).
							(20)2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine
				(2C–E).
							(21)2-(2,5-Dimethoxy-4-methylphenyl)ethanamine
				(2C–D).
							(22)2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine
				(2C–C).
							(23)2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine
				(2C–I).
							(24)2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine
				(2C–T–2).
							(25)2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine
				(2C–T–4).
							(26)2-(2,5-Dimethoxyphenyl)ethanamine
				(2C–H).
							(27)2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine
				(2C–N).
							(28)2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine
				(2C–P).
							.
					1153.Temporary scheduling to avoid imminent
			 hazards to public safety expansionSection 201(h)(2) of the Controlled
			 Substances Act (21 U.S.C. 811(h)(2)) is amended—
					(1)by striking one year and
			 inserting 2 years; and
					(2)by striking six months and
			 inserting 1 year.

			Speaker of the House of Representatives

			Vice President of the United States and President of the
			 Senate