S. 3187 

One Hundred Twelfth Congress 

of the 

United States of America 

AT THE SECOND SESSION 

Begun and held at the City of Washington on Tuesday, 

the third day of January, two thousand and twelve 

An Act 

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the 

user-fee programs for prescription drugs and medical devices, to establish userfee programs for generic drugs and biosimilars, and for other purposes. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Food and Drug Administration 

Safety and Innovation Act’’. 

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

(a) TABLE OF CONTENTS.—The table of contents of this Act 

is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents; references in Act. 

TITLE I—FEES RELATING TO DRUGS 

Sec. 101. Short title; finding. 

Sec. 102. Definitions. 

Sec. 103. Authority to assess and use drug fees. 

Sec. 104. Reauthorization; reporting requirements. 

Sec. 105. Sunset dates. 

Sec. 106. Effective date. 

Sec. 107. Savings clause. 

TITLE II—FEES RELATING TO DEVICES 

Sec. 201. Short title; findings. 

Sec. 202. Definitions. 

Sec. 203. Authority to assess and use device fees. 

Sec. 204. Reauthorization; reporting requirements. 

Sec. 205. Savings clause. 

Sec. 206. Effective date. 

Sec. 207. Sunset clause. 

Sec. 208. Streamlined hiring authority to support activities related to the process 

for the review of device applications. 

TITLE III—FEES RELATING TO GENERIC DRUGS 

Sec. 301. Short title. 

Sec. 302. Authority to assess and use human generic drug fees. 

Sec. 303. Reauthorization; reporting requirements. 

Sec. 304. Sunset dates. 

Sec. 305. Effective date. 

Sec. 306. Amendment with respect to misbranding. 

Sec. 307. Streamlined hiring authority to support activities related to human 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. 
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Sec. 403. Reauthorization; reporting requirements. 

Sec. 404. Sunset dates. 

Sec. 405. Effective date. 

Sec. 406. Savings clause. 

Sec. 407. Conforming amendment. 

Sec. 408. Additional reporting requirements. 

TITLE V—PEDIATRIC DRUGS AND DEVICES 

Sec. 501. Permanence. 

Sec. 502. Written requests. 

Sec. 503. Communication with Pediatric Review Committee. 

Sec. 504. Access to data. 

Sec. 505. Ensuring the completion of pediatric studies. 

Sec. 506. Pediatric study plans. 

Sec. 507. Reauthorizations. 

Sec. 508. Report. 

Sec. 509. Technical amendments. 

Sec. 510. Pediatric rare diseases. 

Sec. 511. Staff of Office of Pediatric Therapeutics. 

TITLE VI—MEDICAL DEVICE REGULATORY IMPROVEMENTS 

Sec. 601. Investigational device exemptions. 

Sec. 602. Clarification of least burdensome standard. 

Sec. 603. Agency documentation and review of significant decisions. 

Sec. 604. Device modifications requiring premarket notification prior to marketing. 

Sec. 605. Program to improve the device recall system. 

Sec. 606. Clinical holds on investigational device exemptions. 

Sec. 607. Modification of de novo application process. 

Sec. 608. Reclassification procedures. 

Sec. 609. Harmonization of device premarket review, inspection, and labeling 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. 
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TITLE IX—DRUG APPROVAL AND PATIENT ACCESS 

Sec. 901. Enhancement of accelerated patient access to new medical treatments. 

Sec. 902. Breakthrough therapies. 

Sec. 903. Consultation with external experts on rare diseases, targeted therapies, 

and genetic targeting of treatments. 

Sec. 904. Accessibility of information on prescription drug container labels by 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 overthe-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. 
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(b) REFERENCES IN ACT.—Except as otherwise specified, amendments made by this Act to a section or other provision of law 

are amendments to such section or other provision of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 

TITLE I—FEES RELATING TO DRUGS 

SEC. 101. SHORT TITLE; FINDING. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Prescription 

Drug User Fee Amendments of 2012’’. 

(b) FINDING.—The Congress finds that the fees authorized by 

the amendments made in this title will be dedicated toward 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. 

SEC. 102. DEFINITIONS. 

Section 735(7) (21 U.S.C. 379g) is amended by striking 

‘‘expenses incurred in connection with’’ and inserting ‘‘expenses 

in connection with’’. 

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

Section 736 (21 U.S.C. 379h) is amended— 

(1) in subsection (a)— 

(A) in the matter preceding paragraph (1), by striking 

‘‘fiscal year 2008’’ and inserting ‘‘fiscal year 2013’’; 

(B) in paragraph (1)(A)— 

(i) in clause (i), by striking ‘‘(c)(5)’’ and inserting 

‘‘(c)(4)’’; and 

(ii) in clause (ii), by striking ‘‘(c)(5)’’ and inserting 

‘‘(c)(4)’’; 

(C) in the matter following clause (ii) in paragraph 

(2)(A)— 

(i) by striking ‘‘(c)(5)’’ and inserting ‘‘(c)(4)’’; and 

(ii) by striking ‘‘payable on or before October 1 

of each year’’ and inserting ‘‘due on the later of the 

first business day on or after October 1 of each fiscal 

year or the first business day after the enactment 

of an appropriations Act providing for the collection 

and obligation of fees for such fiscal year under this 

section’’; 

(D) in paragraph (3)— 

(i) in subparagraph (A)— 

(I) by striking ‘‘subsection (c)(5)’’ and inserting 

‘‘subsection (c)(4)’’; and 

(II) by striking ‘‘payable on or before October 

1 of each year.’’ and inserting ‘‘due on the later 

of the first business day on or after October 1 

of each fiscal year or the first business day after 

the enactment of an appropriations Act providing 
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for the collection and obligation of fees for such 

fiscal year under this section.’’; and 

(ii) by amending subparagraph (B) to read as follows: 

‘‘(B) EXCEPTION.—A prescription drug product shall not 

be assessed a fee under subparagraph (A) if such product 

is— 

‘‘(i) identified on the list compiled under section 

505(j)(7) with a potency described in terms of per 100 

mL; 

‘‘(ii) the same product as another product that— 

‘‘(I) was approved under an application filed 

under section 505(b) or 505(j); and 

‘‘(II) is not in the list of discontinued products 

compiled under section 505(j)(7); 

‘‘(iii) the same product as another product that 

was approved under an abbreviated application filed 

under section 507 (as in effect on the day before the 

date of enactment of the Food and Drug Administration 

Modernization Act of 1997); or 

‘‘(iv) the same product as another product that 

was approved under an abbreviated new drug 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 ADJUSTMENTS.—For purposes of paragraph (1), the dollar amount of 

the inflation and workload adjustments for fiscal year 2013 

shall be determined as follows: 

‘‘(A) INFLATION ADJUSTMENT.—The inflation 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 ADJUSTMENT.—Subject to subparagraph (C), the workload adjustment for fiscal 2013 shall 

be— 
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‘‘(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) LIMITATION.—Under no circumstances shall the 

adjustment under subparagraph (B) result in fee revenues 

for fiscal year 2013 that are less than the sum of the 

amount under paragraph (1)(A) and the amount under 

paragraph (1)(B).’’; 

(3) by striking subsection (c) and inserting the following: 

‘‘(c) ADJUSTMENTS.— 

‘‘(1) INFLATION ADJUSTMENT.—For fiscal year 2014 and 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 ADJUSTMENT.—For fiscal year 2014 and 

subsequent fiscal years, after the fee revenues established in 

subsection (b) are adjusted for a fiscal year for inflation in 

accordance with paragraph (1), the fee revenues shall be 

adjusted further for such fiscal year to reflect changes in the 

workload of the Secretary for the process for the review of 

human drug applications. With respect to such adjustment: 

‘‘(A) The adjustment shall be determined by the Secretary based on a weighted average of the change in the 

total number of human drug applications (adjusted for 
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changes in review activities, as described in the notice 

that the Secretary is required to publish in the Federal 

Register under this subparagraph), efficacy supplements, 

and manufacturing supplements submitted to the 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 ADJUSTMENT.—For fiscal year 2017, the 

Secretary may, in addition to adjustments under this paragraph 

and paragraphs (1) and (2), further increase the fee revenues 

and fees established in subsection (b) if such an adjustment 

is necessary to provide for not more than 3 months of operating 

reserves of carryover user fees for the process for the review 

of human drug applications for the first 3 months of fiscal 

year 2018. If such an adjustment is necessary, the rationale 

for the amount of the increase shall be contained in the annual 

notice establishing fee revenues and fees for fiscal year 2017. 

If the Secretary has carryover balances for such process in 

excess of 3 months of such operating reserves, the adjustment 

under this paragraph shall not be made. 

‘‘(4) ANNUAL FEE SETTING.—The Secretary shall, not later 

than 60 days before the start of each fiscal year that begins 

after September 30, 2012, establish, for the next fiscal year, 

application, product, and establishment fees under subsection 

(a), based on the revenue amounts established under subsection 

(b) and the adjustments provided under this subsection. 

‘‘(5) LIMIT.—The total amount of fees charged, as adjusted 

under this subsection, for a fiscal year may not exceed the 
S. 3187—8 

total costs for such fiscal year for the resources allocated for 

the process for the review of human drug applications.’’; and 

(4) in subsection (g)— 

(A) in paragraph (1), by striking ‘‘Fees authorized’’ 

and inserting ‘‘Subject to paragraph (2)(C), fees authorized’’; 

(B) in paragraph (2)— 

(i) in subparagraph (A)(i), by striking ‘‘shall be 

retained’’ and inserting ‘‘subject to subparagraph (C), 

shall be collected and available’’; 

(ii) in subparagraph (A)(ii), by striking ‘‘shall only 

be collected and available’’ and inserting ‘‘shall be 

available’’; and 

(iii) by adding at the end the following new 

subparagraph: 

‘‘(C) PROVISION FOR EARLY PAYMENTS.—Payment of fees 

authorized under this section for a fiscal year, prior to 

the due date for such fees, may be accepted by the Secretary 

in accordance with authority provided in advance in a 

prior year appropriations Act.’’; 

(C) in paragraph (3), by striking ‘‘fiscal years 2008 

through 2012’’ and inserting ‘‘fiscal years 2013 through 

2017’’; and 

(D) in paragraph (4)— 

(i) by striking ‘‘fiscal years 2008 through 2010’’ 

and inserting ‘‘fiscal years 2013 through 2015’’; 

(ii) by striking ‘‘fiscal year 2011’’ and inserting 

‘‘fiscal year 2016’’; 

(iii) by striking ‘‘fiscal years 2008 through 2011’’ 

and inserting ‘‘fiscal years 2013 through 2016’’; and 

(iv) by striking ‘‘fiscal year 2012’’ and inserting 

‘‘fiscal year 2017’’. 

SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

Section 736B (21 U.S.C. 379h–2) is amended— 

(1) by amending subsection (a) to read as follows: 

‘‘(a) PERFORMANCE REPORT.— ‘‘(1) IN GENERAL.—Beginning with fiscal year 2013, not 

later than 120 days after the end of each fiscal year for which 

fees are collected under this part, the Secretary shall prepare 

and submit to the Committee on Energy and Commerce of 

the House of Representatives and the Committee on Health, 

Education, Labor, and Pensions of the Senate a report 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; 
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‘‘(ii) the number of original priority new drug 

applications and biologics license applications filed per 

fiscal year for each review division; 

‘‘(iii) the number of standard efficacy supplements 

filed per fiscal year for each review division; 

‘‘(iv) the number of priority efficacy supplements 

filed per fiscal year for each review division; 

‘‘(v) the number of applications filed for review 

under accelerated approval per fiscal year for each 

review division; 

‘‘(vi) the number of applications filed for review 

as fast track products per fiscal year for each review 

division; 

‘‘(vii) the number of applications filed for orphandesignated products per fiscal year for each review 

division; and 

‘‘(viii) the number of breakthrough designations 

for a fiscal year for each review division. 

‘‘(2) INCLUSION.—The report under this subsection for a 

fiscal year shall include information on all previous cohorts 

for which the Secretary has not given a complete response 

on all human drug applications and supplements in the cohort.’’. 

(2) in subsection (b), by striking ‘‘2008’’ and inserting 

‘‘2013’’; and 

(3) in subsection (d), by striking ‘‘2012’’ each place it 

appears and inserting ‘‘2017’’. 

SEC. 105. SUNSET DATES. 

(a) AUTHORIZATION.—Sections 735 and 736 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to 

be effective October 1, 2017. 

(b) REPORTING REQUIREMENTS.—Section 736B of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) shall cease to 

be effective January 31, 2018. 

(c) PREVIOUS SUNSET PROVISION.— 

(1) IN GENERAL.—Section 106 of the Food and Drug 

Administration Amendments Act of 2007 (Public Law 110– 

85) is repealed. 

(2) CONFORMING AMENDMENT.—The Food and Drug 

Administration Amendments Act of 2007 (Public Law 110– 

85) is amended in the table of contents in section 2, by striking 

the item relating to section 106. 

(d) TECHNICAL CLARIFICATIONS.— 

(1) Effective September 30, 2007— 

(A) section 509 of the Prescription Drug User Fee 

Amendments Act of 2002 (Title V of Public Law 107– 

188) is repealed; and 

(B) the Public Health Security and Bioterrorism 

Preparedness and Response Act of 2002 (Public Law 107– 

188) is amended in the table of contents in section 1(b), 

by striking the item relating to section 509. 

(2) Effective September 30, 2002— 

(A) section 107 of the Food and Drug Administration 

Modernization Act of 1997 (Public Law 105–115) is 

repealed; and 

(B) the table of contents in section 1(c) of such Act 

is amended by striking the item related to section 107. 
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(3) Effective September 30, 1997, section 105 of the 

Prescription Drug User Fee Act of 1992 (Public Law 102– 

571) is repealed. 

SEC. 106. EFFECTIVE DATE. 

The amendments made by this title shall take effect on October 

1, 2012, or the date of the enactment of this Act, whichever is 

later, except that fees under part 2 of subchapter C of chapter 

VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 

for all human drug applications received on or after October 1, 

2012, regardless of the date of the enactment of this Act. 

SEC. 107. SAVINGS CLAUSE. 

Notwithstanding the amendments made by this title, part 2 

of subchapter C of chapter VII of the Federal Food, Drug, and 

Cosmetic Act, as in effect on the day before the date of the 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. 

TITLE II—FEES RELATING TO DEVICES 

SEC. 201. SHORT TITLE; FINDINGS. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Medical 

Device User Fee Amendments of 2012’’. 

(b) FINDINGS.—The Congress finds that the fees authorized 

under the amendments made by this title will be dedicated toward 

expediting the process for the review of device applications and 

for assuring the safety and effectiveness of devices, as set forth 

in the goals identified for purposes of part 3 of subchapter C 

of chapter VII of the Federal Food, Drug, and Cosmetic Act in 

the letters from the Secretary of Health and Human Services to 

the Chairman of the Committee on Health, Education, Labor, and 

Pensions of the Senate and the Chairman of the Committee on 

Energy and Commerce of the House of Representatives, as set 

forth in the Congressional Record. 

SEC. 202. DEFINITIONS. 

Section 737 (21 U.S.C. 379i) is amended— 

(1) in paragraph (9), by striking ‘‘incurred’’ after ‘‘expenses’’; 

(2) in paragraph (10), by striking ‘‘October 2001’’ and 

inserting ‘‘October 2011’’; and 

(3) in paragraph (13), by striking ‘‘is required to register’’ 

and all that follows through the end of paragraph (13) and 

inserting the following: ‘‘is registered (or is required to register) 

with the Secretary under section 510 because such establishment is engaged in the manufacture, preparation, propagation, 

compounding, or processing of a device.’’. 

SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES. 

(a) TYPES OF FEES.—Section 738(a) (21 U.S.C. 379j(a)) is 

amended— 

(1) in paragraph (1), by striking ‘‘fiscal year 2008’’ and 

inserting ‘‘fiscal year 2013’’; 
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(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 AMOUNTS.—Section 738(b) (21 U.S.C. 379j(b)) is 

amended to read as follows: 

‘‘(b) FEE AMOUNTS.— 

‘‘(1) IN GENERAL.—Subject to subsections (c), (d), (e), (f), 

and (i), for each of fiscal years 2013 through 2017, fees under 

subsection (a) shall be derived from the base fee amounts 

specified in paragraph (2), to generate the total revenue 

amounts specified in paragraph (3). 

‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For purposes of paragraph (1), the base fee amounts specified in this paragraph 

are as follows: 

‘‘Fee Type 

Fiscal 

Year 

2013 

Fiscal 

Year 

2014 

Fiscal 

Year 

2015 

Fiscal 

Year 

2016 

Fiscal 

Year 

2017 

Premarket Application .... $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 SPECIFIED.—For purposes 

of paragraph (1), the total revenue amounts specified in this 

paragraph are as follows: 

‘‘(A) $97,722,301 for fiscal year 2013. 

‘‘(B) $112,580,497 for fiscal year 2014. 

‘‘(C) $125,767,107 for fiscal year 2015. 

‘‘(D) $129,339,949 for fiscal year 2016. 

‘‘(E) $130,184,348 for fiscal year 2017.’’. 

(c) ANNUAL FEE SETTING; ADJUSTMENTS.—Section 738(c) (21 

U.S.C. 379j(c)) is amended— 

(1) in the subsection heading, by inserting ‘‘; ADJUSTMENTS’’ 

after ‘‘SETTING’’; 

(2) by striking paragraphs (1) and (2); 

(3) by redesignating paragraphs (3) and (4) as paragraphs 

(4) and (5), respectively; and 
S. 3187—12 

(4) by inserting before paragraph (4), as so redesignated, 

the following: 

‘‘(1) IN GENERAL.—The Secretary shall, 60 days before the 

start of each fiscal year after September 30, 2012, establish 

fees under subsection (a), based on amounts specified under 

subsection (b) and the adjustments provided under this 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 AMOUNTS.—For 

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 AMOUNTS.—The 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 GENERAL.—Subject to further adjustment 

under clause (ii), the base inflation adjustment for 

a fiscal year is the sum of one plus— 

‘‘(I) the average annual percent change in the 

cost, per full-time equivalent position of the Food 

and Drug Administration, of all personnel 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) LIMITATIONS.—For 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 AMOUNTS.—For 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 
S. 3187—13 

revenue amounts under subsection (b)(3), as adjusted for 

inflation under subparagraph (A). 

‘‘(3) VOLUME-BASED ADJUSTMENTS TO ESTABLISHMENT REGISTRATION BASE FEES.—For 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 REDUCTION.—Section 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 GENERAL.—The 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) LIMITATION.—The 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) DURATION.—The authority provided by this subsection 

terminates October 1, 2017.’’. 

(e) CONDITIONS.—Section 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 FEES.—Section 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 PAYMENTS.—Payment of fees 

authorized under this section for a fiscal year, prior to 

the due date for such fees, may be accepted by the Secretary 

in accordance with authority provided in advance in a 

prior year appropriations Act.’’; 

(3) by amending paragraph (3) to read as follows: 

‘‘(3) AUTHORIZATIONS OF APPROPRIATIONS.—For 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 
S. 3187—14 

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 AMENDMENT.—Section 515(c)(4)(A) (21 U.S.C. 

360e(c)(4)(A)) is amended by striking ‘‘738(g)’’ and inserting ‘‘738(h)’’. 

SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS. 

(a) REAUTHORIZATION.—Section 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 REPORTS.—Section 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 GENERAL.—Beginning 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) PUBLICATION.—With 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) UPDATES.—The 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, 
S. 3187—15 

supplements, and premarket notifications in the cohort.’’; 

and 

(2) in paragraph (2), by striking ‘‘2008 through 2012’’ and 

inserting ‘‘2013 through 2017’’. 

SEC. 205. SAVINGS CLAUSE. 

Notwithstanding 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. 

SEC. 206. EFFECTIVE DATE. 

The amendments made by this title shall take effect on October 

1, 2012, or the date of the enactment of this Act, whichever is 

later, except that fees under part 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. 

SEC. 207. SUNSET CLAUSE. 

(a) IN GENERAL.—Sections 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 GENERAL.—Section 217 of the Food and Drug 

Administration Amendments Act of 2007 (Title II of Public 

Law 110–85) is repealed. 

(2) CONFORMING AMENDMENT.—The Food and Drug 

Administration Amendments Act of 2007 (Public Law 110– 

85) is amended in the table of contents in section 2, by striking 

the item relating to section 217. 

(c) TECHNICAL CLARIFICATION.—Effective 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. 

SEC. 208. STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES 

RELATED TO THE PROCESS FOR THE REVIEW OF DEVICE 

APPLICATIONS. 

Subchapter A of chapter VII (21 U.S.C. 371 et seq.) is amended 

by inserting after section 713 the following new section: 

‘‘SEC. 714. STREAMLINED HIRING AUTHORITY. 

‘‘(a) IN GENERAL.—In addition to any other personnel authorities under other provisions of law, the Secretary may, without 

regard to the provisions of title 5, United States Code, governing 
S. 3187—16 

appointments in the competitive service, appoint employees to positions in the Food and Drug Administration to perform, administer, 

or support activities described in subsection (b), if the Secretary 

determines that such appointments are needed to achieve the objectives specified in subsection (c). 

‘‘(b) ACTIVITIES DESCRIBED.—The activities described in this 

subsection are activities under this Act related to the process for 

the review of device applications (as defined in section 737(8)). 

‘‘(c) OBJECTIVES SPECIFIED.—The 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 CONTROLS.—The Secretary shall institute appropriate internal controls for appointments under this section. 

‘‘(e) SUNSET.—The authority to appoint employees under this 

section shall terminate on the date that is 3 years after the date 

of enactment of this section.’’. 

TITLE III—FEES RELATING TO GENERIC 

DRUGS 

SEC. 301. SHORT TITLE. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Generic 

Drug User Fee Amendments of 2012’’. 

(b) FINDING.—The Congress finds that the fees authorized by 

the amendments made in this title will be dedicated 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. 

SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 

FEES. 

Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended 

by adding at the end the following: 

‘‘PART 7—FEES RELATING TO GENERIC DRUGS 

‘‘SEC. 744A. DEFINITIONS. 

‘‘For purposes of this part: 

‘‘(1) The term ‘abbreviated new drug application’— 

‘‘(A) means an application submitted under section 

505(j), an abbreviated application submitted under section 

507 (as in effect on the day before the date of enactment 

of the Food and Drug Administration Modernization Act 

of 1997), or an abbreviated new drug application submitted 

pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984; and 

‘‘(B) does not include an application for a positron 

emission tomography drug. 

‘‘(2) The term ‘active pharmaceutical ingredient’ means— 

‘‘(A) a substance, or a mixture when the substance 

is unstable or cannot be transported on its own, intended— 
S. 3187—17 

‘‘(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 
S. 3187—18 

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 
S. 3187—19 

have an adverse effect on the identity, strength, quality, purity, 

or potency of the drug product as these factors may relate 

to the safety or effectiveness of the drug product. 

‘‘(11) The term ‘resources allocated for human generic drug 

activities’ means the expenses for— 

‘‘(A) officers and employees of the Food and Drug 

Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such 

officers and employees and to contracts with such contractors; 

‘‘(B) management of information, and the acquisition, 

maintenance, and repair of computer resources; 

‘‘(C) leasing, maintenance, renovation, and repair of 

facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary 

materials and supplies; and 

‘‘(D) collecting fees under subsection (a) and accounting 

for resources allocated for the review of abbreviated new 

drug applications and supplements and inspection related 

to generic drugs. 

‘‘(12) The term ‘Type II active pharmaceutical ingredient 

drug master file’ means a submission of information to the 

Secretary by a person that intends to authorize the Food and 

Drug Administration to reference the information to support 

approval of a generic drug submission without the submitter 

having to disclose the information to the generic drug submission applicant. 

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

FEES. 

‘‘(a) TYPES OF FEES.—Beginning in fiscal year 2013, the Secretary shall assess and collect fees in accordance with this section 

as follows: 

‘‘(1) ONE-TIME BACKLOG FEE FOR ABBREVIATED NEW DRUG

APPLICATIONS PENDING ON OCTOBER 1, 2012.— 

‘‘(A) IN GENERAL.—Each person that owns an abbreviated new drug application that is pending on October 

1, 2012, and that has not received a tentative approval 

prior to that date, shall be subject to a fee for each such 

application, as calculated under subparagraph (B). 

‘‘(B) METHOD OF FEE AMOUNT CALCULATION.—The 

amount of each one-time backlog fee shall be calculated 

by dividing $50,000,000 by the total number of abbreviated 

new drug applications pending on October 1, 2012, that 

have not received a tentative approval as of that date. 

‘‘(C) NOTICE.—Not later than October 31, 2012, the 

Secretary shall publish in the Federal Register a notice 

announcing the amount of the fee required by subparagraph (A). 

‘‘(D) FEE DUE DATE.—The fee required by subparagraph 

(A) shall be due no later than 30 calendar days after 

the date of the publication of the notice specified in 

subparagraph (C). 

‘‘(2) DRUG MASTER FILE FEE.— ‘‘(A) IN GENERAL.—Each person that owns a Type II 

active pharmaceutical ingredient drug master file that is 

referenced on or after October 1, 2012, in a generic drug 
S. 3187—20 

submission by any initial letter of authorization shall be 

subject to a drug master file fee. 

‘‘(B) ONE-TIME PAYMENT.—If a person has paid a drug 

master file fee for a Type II active pharmaceutical ingredient drug master file, the person shall not be required 

to pay a subsequent drug master file fee when that Type 

II active pharmaceutical ingredient drug master file is 

subsequently referenced in generic drug submissions. 

‘‘(C) NOTICE.— 

‘‘(i) FISCAL YEAR 2013.—Not later than October 31, 

2012, the Secretary shall 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 2017.—Not 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 GENERAL.—Subject to subsection (g)(2)(C), 

for a generic drug submission to reference a Type 

II active pharmaceutical ingredient drug master file, 

the drug master file must be deemed available for 

reference by the Secretary. 

‘‘(ii) CONDITIONS.—A drug master file shall be 

deemed available for reference by the Secretary if— 

‘‘(I) the person that owns a Type II active 

pharmaceutical ingredient drug master file has 

paid the fee required under subparagraph (A) 

within 20 calendar days after the applicable due 

date under subparagraph (E); and 

‘‘(II) the drug master file has not failed an 

initial completeness assessment by the Secretary, 

in accordance with criteria to be published by the 

Secretary. 

‘‘(iii) LIST.—The Secretary shall make 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 GENERAL.—Subject 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) LIMITATION.—No fee shall be due under 

subparagraph (A) for a fiscal year until the later of— 

‘‘(I) 30 calendar days after publication of the 

notice provided for in clause (i) or (ii) of subparagraph (C), as applicable; or 

‘‘(II) 30 calendar days after the date of enactment of an appropriations Act providing for the 

collection and obligation of fees under this section. 
S. 3187—21 

‘‘(3) ABBREVIATED NEW DRUG APPLICATION AND PRIOR

APPROVAL SUPPLEMENT FILING FEE.— ‘‘(A) IN GENERAL.—Each applicant that submits, on 

or after October 1, 2012, an abbreviated new drug application or a prior approval supplement to an abbreviated 

new drug application shall be subject to a fee for each 

such submission in the amount established under subsection (d). 

‘‘(B) NOTICE.— ‘‘(i) FISCAL YEAR 2013.—Not later than October 31, 

2012, the Secretary shall 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 2017.—Not 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 GENERAL.—Except as provided in clause 

(ii), the fees required by subparagraphs (A) and (F) 

shall be due no later than the date of submission 

of the abbreviated new drug application or prior 

approval supplement for which such fee applies. 

‘‘(ii) SPECIAL RULE FOR 2013.—For fiscal year 2013, 

such fees shall be due on the later of— 

‘‘(I) the date on which the fee is due under 

clause (i); 

‘‘(II) 30 calendar days after publication of the 

notice referred to in subparagraph (B)(i); or 

‘‘(III) if an appropriations Act is not enacted 

providing for the collection and obligation of fees 

under this section by the date of submission of 

the application or prior approval supplement for 

which the fees under subparagraphs (A) and (F) 

apply, 30 calendar days after the date that such 

an appropriations Act is enacted. 

‘‘(D) REFUND OF FEE IF ABBREVIATED NEW DRUG

APPLICATION IS NOT CONSIDERED TO HAVE BEEN RECEIVED.— 

The Secretary shall refund 75 percent of the fee paid under 

subparagraph (A) for any abbreviated new drug application 

or prior approval supplement to an abbreviated new drug 

application that the Secretary considers not to have been 

received within the meaning of section 505(j)(5)(A) for a 

cause other than failure to pay fees. 

‘‘(E) FEE FOR AN APPLICATION THE SECRETARY CONSIDERS NOT TO HAVE BEEN RECEIVED, OR THAT HAS BEEN

WITHDRAWN.—An abbreviated new drug application or prior 

approval supplement that was submitted on or after 

October 1, 2012, and that the Secretary considers not to 

have been received, or that has been withdrawn, shall, 

upon resubmission of the application or a subsequent new 

submission following the applicant’s withdrawal of the 

application, be subject to a full fee under subparagraph 

(A). 

‘‘(F) ADDITIONAL FEE FOR ACTIVE PHARMACEUTICAL

INGREDIENT INFORMATION NOT INCLUDED BY REFERENCE TO
S. 3187—22 

TYPE II ACTIVE PHARMACEUTICAL INGREDIENT DRUG MASTER

FILE.—An applicant that submits a generic drug submission 

on or after October 1, 2012, shall pay a fee, in the amount 

determined under subsection (d)(3), in addition to the fee 

required under subparagraph (A), if— 

‘‘(i) such submission contains information concerning the manufacture of an active pharmaceutical 

ingredient at a facility by means other than reference 

by a letter of authorization to a Type II active pharmaceutical drug master file; and 

‘‘(ii) a fee in the amount equal to the drug master 

file fee established in paragraph (2) has not been previously paid with respect to such information. 

‘‘(4) GENERIC DRUG FACILITY FEE AND ACTIVE PHARMACEUTICAL INGREDIENT FACILITY FEE.— 

‘‘(A) IN GENERAL.—Facilities identified, or intended to 

be identified, in at least one generic drug submission that 

is pending or approved to produce a finished dosage form 

of a human generic drug or an active pharmaceutical ingredient contained in a human generic drug shall be subject 

to fees as follows: 

‘‘(i) GENERIC DRUG FACILITY.—Each person that 

owns a facility which is identified or intended to be 

identified in at least one generic drug submission that 

is pending or approved to produce one or more finished 

dosage forms of a human generic drug shall be assessed 

an annual fee for each such facility. 

‘‘(ii) ACTIVE PHARMACEUTICAL INGREDIENT

FACILITY.—Each person that owns a facility which produces, or which is pending review to produce, one 

or more active pharmaceutical ingredients identified, 

or intended to be identified, in at least one generic 

drug submission that is pending or approved or in 

a Type II active pharmaceutical ingredient drug master 

file referenced in such a generic drug submission, shall 

be assessed an annual fee for each such facility. 

‘‘(iii) FACILITIES PRODUCING BOTH ACTIVE PHARMACEUTICAL INGREDIENTS AND FINISHED DOSAGE FORMS.— 

Each person that owns a facility identified, or intended 

to be identified, in at least one generic drug submission 

that is pending or approved to produce both one or 

more finished dosage forms subject to clause (i) and 

one or more active pharmaceutical ingredients subject 

to clause (ii) shall be subject to fees under both such 

clauses for that facility. 

‘‘(B) AMOUNT.—The amount of fees established under 

subparagraph (A) shall be established under subsection 

(d). 

‘‘(C) NOTICE.— 

‘‘(i) FISCAL YEAR 2013.—For fiscal year 2013, the 

Secretary shall 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 2017.—Within the 

timeframe specified in subsection (d)(2), the Secretary 
S. 3187—23 

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 2013.—For fiscal year 2013, the 

fees under subparagraph (A) shall be due on the later 

of— 

‘‘(I) not later than 45 days after the publication 

of the notice under subparagraph (B); or 

‘‘(II) if an appropriations Act is not enacted 

providing for the collection and obligation of fees 

under this section by the date of the publication 

of such notice, 30 days after the date that such 

an appropriations Act is enacted. 

‘‘(ii) FISCAL YEARS 2014 THROUGH 2017.—For each 

of fiscal years 2014 through 2017, the fees under 

subparagraph (A) for such fiscal year shall be due 

on the later of— 

‘‘(I) the first business day on or after October 

1 of each such year; or 

‘‘(II) the first business day after the enactment 

of an appropriations Act providing for the collection 

and obligation of fees under this section for such 

year. 

‘‘(5) DATE OF SUBMISSION.—For purposes of this 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 2013.—For fiscal year 2013, fees under 

subsection (a) shall be established to generate a total estimated revenue amount under such subsection of 

$299,000,000. Of that amount— 

‘‘(i) $50,000,000 shall be generated by the onetime backlog fee for generic drug applications pending 

on October 1, 2012, established in subsection (a)(1); 

and 

‘‘(ii) $249,000,000 shall be generated by the fees 

under paragraphs (2) through (4) of subsection (a). 

‘‘(B) FISCAL YEARS 2014 THROUGH 2017.—For each of 

the fiscal years 2014 through 2017, fees under paragraphs 

(2) through (4) of subsection (a) shall be established to 

generate a total estimated revenue amount under such 

subsection that is equal to $299,000,000, as adjusted pursuant to subsection (c). 
S. 3187—24 

‘‘(2) TYPES OF FEES.—In establishing fees under paragraph 

(1) to generate the revenue amounts specified in paragraph 

(1)(A)(ii) for fiscal year 2013 and 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 ADJUSTMENT.—For fiscal year 2014 and subsequent fiscal years, the revenues established in subsection 

(b) shall be adjusted by the Secretary by notice, published 

in the Federal Register, for a fiscal year, by an amount equal 

to the sum of— 

‘‘(A) one; 

‘‘(B) the average annual 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 
S. 3187—25 

the proportion of all costs other than personnel compensation and benefits costs to total costs of human generic 

drug activities for the first 3 years of the preceding 4 

fiscal years. 

The adjustment made each fiscal year under this subsection 

shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2013 under this 

subsection. 

‘‘(2) FINAL YEAR ADJUSTMENT.—For fiscal year 2017, the 

Secretary may, in addition to adjustments under paragraph 

(1), further increase the fee revenues and fees established in 

subsection (b) if such an adjustment is necessary to provide 

for not more than 3 months of operating reserves of carryover 

user fees for human generic drug activities for the first 3 

months of fiscal year 2018. Such fees may only be used in 

fiscal year 2018. If such an adjustment is necessary, the 

rationale for the amount of the increase shall be contained 

in the annual notice establishing fee revenues and fees for 

fiscal year 2017. If the Secretary has carryover balances for 

such activities in excess of 3 months of such operating reserves, 

the adjustment under this subparagraph shall not be made. 

‘‘(d) ANNUAL FEE SETTING.— 

‘‘(1) FISCAL YEAR 2013.—For fiscal year 2013— 

‘‘(A) the Secretary shall establish, by October 31, 2012, 

the one-time generic drug backlog fee for generic drug 

applications pending on October 1, 2012, the drug master 

file fee, the abbreviated new drug application fee, and 

the prior approval supplement fee under subsection (a), 

based on the revenue amounts established under subsection 

(b); and 

‘‘(B) the Secretary shall establish, not later than 45 

days after the date to comply with the requirement for 

identification of facilities in subsection (f)(2), the generic 

drug facility fee and active pharmaceutical ingredient 

facility fee under subsection (a) based on the revenue 

amounts established under subsection (b). 

‘‘(2) FISCAL YEARS 2014 THROUGH 2017.—Not more than 60 

days before the first day of each of fiscal years 2014 through 

2017, the Secretary shall establish the drug master file fee, 

the abbreviated new drug application fee, the prior approval 

supplement fee, the generic drug facility fee, and the active 

pharmaceutical ingredient facility fee under subsection (a) for 

such fiscal year, based on the revenue amounts established 

under subsection (b) and the adjustments provided under subsection (c). 

‘‘(3) FEE FOR ACTIVE PHARMACEUTICAL INGREDIENT

INFORMATION NOT INCLUDED BY REFERENCE TO TYPE II ACTIVE

PHARMACEUTICAL INGREDIENT DRUG MASTER FILE.—In establishing the fees under paragraphs (1) and (2), the amount 

of the fee under subsection (a)(3)(F) shall be determined by 

multiplying— 

‘‘(A) the sum of— 

‘‘(i) the total number of such active pharmaceutical 

ingredients in such submission; and 

‘‘(ii) for each such ingredient that is manufactured 

at more than one such facility, the total number of 

such additional facilities; and 
S. 3187—26 

‘‘(B) the amount equal to the drug master file fee 

established in subsection (a)(2) for such submission. 

‘‘(e) LIMIT.—The total amount of fees charged, as adjusted under 

subsection (c), for a fiscal year may not exceed the total costs 

for such fiscal year for the resources allocated for human generic 

drug activities. 

‘‘(f) IDENTIFICATION OF FACILITIES.— ‘‘(1) PUBLICATION OF NOTICE; DEADLINE FOR COMPLIANCE.— Not later than October 1, 2012, the Secretary shall 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 IDENTIFICATION.— 

Each person that owns a facility described in subsection 

(a)(4)(A) or a site or organization required to be identified 

by paragraph (4) shall submit to the Secretary the information 

required under this subsection each year. Such information 

shall— 

‘‘(A) for fiscal year 2013, be submitted not later than 

60 days after the publication of the notice under paragraph 

(1); and 

‘‘(B) for each subsequent fiscal year, be submitted, 

updated, or reconfirmed on or before June 1 of the previous 

year. 

‘‘(3) CONTENTS OF NOTICE.—At a minimum, the submission 

required by paragraph (2) shall include for each such facility— 

‘‘(A) identification of a facility identified or intended 

to be identified in an approved or pending generic drug 

submission; 

‘‘(B) whether the facility manufactures active pharmaceutical ingredients or finished dosage forms, or both; 

‘‘(C) whether or not the facility is located within the 

United States and its territories and possessions; 

‘‘(D) whether the facility manufactures positron emission tomography drugs solely, or in addition to other drugs; 

and 

‘‘(E) whether the facility manufactures drugs that are 

not generic drugs. 

‘‘(4) CERTAIN SITES AND ORGANIZATIONS.— 

‘‘(A) IN GENERAL.—Any person that owns or operates 

a site or organization described in subparagraph (B) shall 

submit to the Secretary information concerning the ownership, name, and address of the site or organization. 

‘‘(B) SITES AND ORGANIZATIONS.—A site or organization 

is described in this subparagraph if it is identified in a 

generic drug submission and is— 

‘‘(i) a site in which a bioanalytical study is conducted; 

‘‘(ii) a clinical research organization; 

‘‘(iii) a contract analytical testing site; or 

‘‘(iv) a contract repackager site. 

‘‘(C) NOTICE.—The Secretary may, by notice published 

in the Federal Register, specify the means and format 
S. 3187—27 

for submission of the information under subparagraph (A) 

and may specify, as necessary for purposes of this section, 

any additional information to be submitted. 

‘‘(D) INSPECTION AUTHORITY.—The Secretary’s 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 FEE.—Failure to pay the fee 

under subsection (a)(1) shall result in the Secretary placing 

the person that owns the abbreviated new drug application 

subject to that fee on 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 FEE.—Failure to pay a fee under 

subparagraph (A) or (F) of subsection (a)(3) within 20 calendar 

days of the applicable due date under subparagraph (C) of 

such subsection shall result in the abbreviated new drug 

application or the prior approval supplement to an abbreviated 
S. 3187—28 

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 PHARMA- CEUTICAL INGREDIENT FACILITY FEE.— ‘‘(A) IN GENERAL.—Failure to pay the fee under subsection (a)(4) within 20 calendar days of the due date 

as specified in subparagraph (D) of such subsection shall 

result in the following: 

‘‘(i) The Secretary shall place the facility on a 

publicly available arrears list, such that no new abbreviated new drug application or supplement submitted 

on or after October 1, 2012, from the person that 

is responsible for paying such fee, or any affiliate of 

that person, will be received within the meaning of 

section 505(j)(5)(A). 

‘‘(ii) Any new generic drug submission submitted 

on or after October 1, 2012, that references such a 

facility shall not be received, within the meaning of 

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 PENALTIES.—The penalties under 

this paragraph shall apply until the fee established by 

subsection (a)(4) is paid or the facility is removed from 

all generic drug submissions that refer to the facility. 

‘‘(C) NONRECEIVAL FOR NONPAYMENT.— ‘‘(i) NOTICE.—If an abbreviated new drug application or supplement to an abbreviated new drug application submitted on or after October 1, 2012, references 

a facility for which a facility fee has not been paid 

by the applicable date under subsection (a)(4)(C), the 

Secretary shall notify the sponsor of the generic drug 

submission of the failure of the owner of the facility 

to pay the facility fee. 

‘‘(ii) NONRECEIVAL.—If the facility fee is not paid 

within 20 calendar days of the Secretary providing 

the notification under clause (i), the abbreviated new 

drug application or supplement to an abbreviated new 

drug application shall not be received within the 

meaning of section 505(j)(5)(A). 

‘‘(h) LIMITATIONS.— 

‘‘(1) IN GENERAL.—Fees under subsection (a) shall be 

refunded for a fiscal year beginning after fiscal year 2012, 

unless appropriations for salaries and expenses of the Food 

and Drug Administration for such fiscal year (excluding the 

amount of fees appropriated for such fiscal year) are equal 

to or greater than the amount of appropriations for the salaries 

and expenses of the Food and Drug Administration for 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. 
S. 3187—29 

‘‘(2) AUTHORITY.—If the Secretary does not assess fees 

under subsection (a) during any portion of a fiscal year and 

if at a later date in such fiscal year the Secretary may assess 

such fees, the Secretary may assess and collect such fees, 

without any modification in the rate, for Type II active pharmaceutical ingredient drug master files, abbreviated new drug 

applications and prior approval supplements, and generic drug 

facilities and active pharmaceutical ingredient facilities at any 

time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid. 

‘‘(i) CREDITING AND AVAILABILITY OF FEES.— 

‘‘(1) IN GENERAL.—Fees authorized under subsection (a) 

shall be collected and available for obligation only to the extent 

and in the amount provided in advance in appropriations Acts, 

subject to paragraph (2). Such fees are authorized to remain 

available until expended. Such sums as may be necessary may 

be transferred from the Food and Drug Administration salaries 

and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses 

with such fiscal year limitation. The sums transferred shall 

be available solely for human generic drug activities. 

‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.— 

‘‘(A) IN GENERAL.—The fees authorized by this section— 

‘‘(i) subject to subparagraphs (C) and (D), shall 

be collected and available in each fiscal year in an 

amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and 

‘‘(ii) shall be available for a fiscal year beginning 

after fiscal year 2012 to defray the costs of human 

generic drug activities (including such costs for an 

additional number of full-time equivalent positions in 

the Department of Health and Human Services to be 

engaged in such activities), only if the Secretary allocates for such purpose an amount for such fiscal year 

(excluding amounts from fees collected under this section) no less than $97,000,000 multiplied by the adjustment factor defined in section 744A(3) applicable to 

the fiscal year involved. 

‘‘(B) COMPLIANCE.—The Secretary shall be considered 

to have met the requirements of subparagraph (A)(ii) in 

any fiscal year if the costs funded by appropriations and 

allocated for human generic activities are not more than 

10 percent below the level specified in such subparagraph. 

‘‘(C) FEE COLLECTION DURING FIRST PROGRAM YEAR.— 

Until the date of enactment of an Act making appropriations through September 30, 2013 for the salaries and 

expenses account of the Food and Drug Administration, 

fees authorized by this section for fiscal year 2013, may 

be collected and shall be credited to such account and 

remain available until expended. 

‘‘(D) PROVISION FOR EARLY PAYMENTS IN SUBSEQUENT

YEARS.—Payment of fees authorized under this section for 

a fiscal year (after fiscal year 2013), prior to the due 

date for such fees, may be accepted by the Secretary in 
S. 3187—30 

accordance with authority provided in advance in a prior 

year appropriations Act. 

‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the 

fiscal years 2013 through 2017, there is authorized to be appropriated for fees under this section an amount equivalent to 

the total revenue amount determined under subsection (b) for 

the fiscal year, as adjusted under subsection (c), if applicable, 

or as otherwise affected under paragraph (2) of this subsection. 

‘‘(j) COLLECTION OF UNPAID FEES.—In any case where the Secretary does not receive payment of a fee assessed under subsection 

(a) within 30 calendar days after it is due, such fee shall be 

treated as a claim of the United States Government subject to 

subchapter II of chapter 37 of title 31, United States Code. 

‘‘(k) CONSTRUCTION.—This section may not be construed to 

require that the number of full-time equivalent positions in the 

Department of Health and Human Services, for officers, employees, 

and advisory committees not engaged in human generic drug activities, be reduced to offset the number of officers, employees, and 

advisory committees so engaged. 

‘‘(l) POSITRON EMISSION TOMOGRAPHY DRUGS.— ‘‘(1) EXEMPTION FROM FEES.—Submission of an application 

for a positron emission tomography drug or active pharmaceutical ingredient for a positron emission tomography drug 

shall not require the payment of any fee under this section. 

Facilities that solely produce positron emission tomography 

drugs shall not be required to pay a facility fee as established 

in subsection (a)(4). 

‘‘(2) IDENTIFICATION REQUIREMENT.—Facilities that produce 

positron emission tomography drugs or active pharmaceutical 

ingredients of such drugs are required to be identified pursuant 

to subsection (f). 

‘‘(m) DISPUTES CONCERNING FEES.—To qualify for the return 

of a fee claimed to have been paid in error under this section, 

a person shall submit to the Secretary a written request justifying 

such return within 180 calendar days after such fee was paid. 

‘‘(n) SUBSTANTIALLY COMPLETE APPLICATIONS.—An abbreviated 

new drug application that is not considered to be received within 

the meaning of section 505(j)(5)(A) because of failure to pay an 

applicable fee under this provision within the time period specified 

in subsection (g) shall be deemed not to have been ‘substantially 

complete’ on the date of its submission within the meaning of 

section 505(j)(5)(B)(iv)(II)(cc). An abbreviated new drug application 

that is not substantially complete on the date of its submission 

solely because of failure to pay an applicable fee under the preceding 

sentence shall be deemed substantially complete and received 

within the meaning of section 505(j)(5)(A) as of the date such 

applicable fee is received.’’. 

SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS. 

Part 7 of subchapter C of chapter VII, as added by section 

302 of this Act, is amended by inserting after section 744B the 

following: 

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

‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal year 2013, 

not later than 120 days after the end of each fiscal year for which 

fees are collected under this part, the Secretary shall prepare and 

submit to the Committee on Energy and Commerce of the House 
S. 3187—31 

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 REPORT.—Beginning with fiscal year 2013, not later 

than 120 days after the end of each fiscal year for which fees 

are collected under this part, the Secretary shall prepare and submit 

to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and 

Pensions of the Senate a report on the implementation of the 

authority for such fees during such fiscal year and the use, by 

the Food and Drug Administration, of the fees collected for such 

fiscal year. 

‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall make the 

reports required under subsections (a) and (b) available to the 

public on the Internet Web site of the Food and Drug Administration. 

‘‘(d) REAUTHORIZATION.— 

‘‘(1) CONSULTATION.—In developing recommendations to 

present to the Congress with respect to the goals, and plans 

for meeting the goals, for human generic drug activities for 

the first 5 fiscal years after fiscal year 2017, and for the 

reauthorization of this part for such fiscal years, the Secretary 

shall consult with— 

‘‘(A) the Committee on Energy and Commerce of the 

House of Representatives; 

‘‘(B) the Committee on Health, Education, Labor, and 

Pensions of the Senate; 

‘‘(C) scientific and academic experts; 

‘‘(D) health care professionals; 

‘‘(E) representatives of patient and consumer advocacy 

groups; and 

‘‘(F) the generic drug industry. 

‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations 

with the generic drug industry on the reauthorization of this 

part, the Secretary shall— 

‘‘(A) publish a notice in the Federal Register requesting 

public input on the reauthorization; 

‘‘(B) hold a public meeting at which the public may 

present its views on the reauthorization, including specific 

suggestions for changes to the goals referred to in subsection (a); 

‘‘(C) provide a period of 30 days after the public meeting 

to obtain written comments from the public suggesting 

changes to this part; and 

‘‘(D) publish the comments on the Food and Drug 

Administration’s Internet Web site. 

‘‘(3) PERIODIC CONSULTATION.—Not less frequently than 

once every month during negotiations with the generic drug 

industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue 

discussions of their views on the reauthorization and their 

suggestions for changes to this part as expressed under paragraph (2). 
S. 3187—32 

‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotiations with the generic drug industry, the Secretary shall— 

‘‘(A) present the recommendations developed under 

paragraph (1) to the congressional committees specified 

in such paragraph; 

‘‘(B) publish such recommendations in the Federal Register; 

‘‘(C) provide for a period of 30 days for the public 

to provide written comments on such recommendations; 

‘‘(D) hold a meeting at which the public may present 

its views on such recommendations; and 

‘‘(E) after consideration of such public views and comments, revise such recommendations as necessary. 

‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 

January 15, 2017, the Secretary shall transmit to the Congress 

the revised recommendations under paragraph (4), a summary 

of the views and comments received under such paragraph, 

and any changes made to the recommendations in response 

to such views and comments. 

‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 

‘‘(A) PUBLIC AVAILABILITY.—Before presenting the recommendations developed under paragraphs (1) through (5) 

to the Congress, the Secretary shall make publicly available, on the 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) CONTENT.—The minutes described under subparagraph (A) shall summarize any substantive proposal made 

by any party to the negotiations as well as significant 

controversies or differences of opinion during the negotiations and their resolution.’’. 

SEC. 304. SUNSET DATES. 

(a) AUTHORIZATION.—Sections 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 REQUIREMENTS.—Section 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. 

SEC. 305. EFFECTIVE DATE. 

The amendments made by this title shall take effect on October 

1, 2012, or the date of the enactment of this title, whichever 

is later, except that fees under section 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. 

SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING. 

Section 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 
S. 3187—33 

pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or processed in such a facility.’’. 

SEC. 307. STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES 

RELATED TO HUMAN GENERIC DRUGS. 

Section 714, as added by section 208 of this Act, is amended— 

(1) by amending subsection (b) to read as follows: 

‘‘(b) ACTIVITIES DESCRIBED.—The 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 SPECIFIED.—The 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).’’. 

SEC. 308. ADDITIONAL REPORTING REQUIREMENTS. 

Subchapter 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: 

‘‘SEC. 715. REPORTING REQUIREMENTS. 

‘‘(a) GENERIC DRUGS.—Beginning 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 
S. 3187—34 

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.’’. 

TITLE IV—FEES RELATING TO 

BIOSIMILAR BIOLOGICAL PRODUCTS 

SEC. 401. SHORT TITLE; FINDING. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Biosimilar 

User Fee Act of 2012’’. 

(b) FINDING.—The Congress finds that the fees authorized by 

the amendments made in this title will be dedicated to expediting 

the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the 

goals identified for purposes of part 8 of subchapter C of chapter 

VII of the Federal Food, Drug, and Cosmetic Act, in the letters 

from the Secretary of Health and Human Services to the Chairman 

of the Committee on Health, Education, Labor, and Pensions of 

the Senate and the Chairman of the Committee on Energy and 

Commerce of the House of Representatives, as set forth in the 

Congressional Record. 

SEC. 402. FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS. 

Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended 

by inserting after part 7, as added by title III of this Act, the 

following: 

‘‘PART 8—FEES RELATING TO BIOSIMILAR 

BIOLOGICAL PRODUCTS 

‘‘SEC. 744G. DEFINITIONS. 

‘‘For purposes of this part: 

‘‘(1) The term ‘adjustment factor’ applicable to a fiscal 

year that is the Consumer Price Index for all urban consumers 

(Washington-Baltimore, DC–MD–VA–WV; Not Seasonally 

Adjusted; All items) of the preceding fiscal year divided by 

such Index for September 2011. 

‘‘(2) The term ‘affiliate’ means a business entity that has 

a relationship with a second business entity if, directly or 

indirectly— 

‘‘(A) one business entity controls, or has the power 

to control, the other business entity; or 

‘‘(B) a third party controls, or has power to control, 

both of the business entities. 

‘‘(3) The term ‘biosimilar biological product’ means a 

product for which a biosimilar biological product application 

has been approved. 

‘‘(4)(A) Subject to subparagraph (B), the term ‘biosimilar 

biological product application’ means an application for licensure of a biological product under section 351(k) of the Public 

Health Service Act. 

‘‘(B) Such term does not include— 

‘‘(i) a supplement to such an application; 
S. 3187—35 

‘‘(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; 
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‘‘(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. 
S. 3187—37 

‘‘(ii) Developing and using improved adverse-event 

data-collection systems, including information technology systems. 

‘‘(iii) Developing and using improved analytical 

tools to assess potential safety problems, including 

access to external data bases. 

‘‘(iv) Implementing and enforcing section 505(o) 

(relating to postapproval studies and clinical trials and 

labeling changes) and section 505(p) (relating to risk 

evaluation and mitigation strategies). 

‘‘(v) Carrying out section 505(k)(5) (relating to 

adverse-event reports and postmarket safety activities). 

‘‘(14) The term ‘supplement’ means a request to the Secretary to approve a change in a biosimilar biological product 

application which has been approved, including a supplement 

requesting that the Secretary determine that the biosimilar 

biological product meets the standards for interchangeability 

described in section 351(k)(4) of the Public Health Service Act. 

‘‘SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL 

PRODUCT FEES. 

‘‘(a) TYPES OF FEES.—Beginning in fiscal year 2013, the Secretary shall assess and collect fees in accordance with this section 

as follows: 

‘‘(1) BIOSIMILAR DEVELOPMENT PROGRAM FEES.— 

‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT FEE.— 

‘‘(i) IN GENERAL.—Each person that submits to the 

Secretary a meeting request described under clause 

(ii) or a clinical protocol for an investigational new 

drug protocol described under clause (iii) shall pay 

for the product named in the meeting request or the 

investigational new drug application the initial biosimilar biological product development fee established 

under subsection (b)(1)(A). 

‘‘(ii) MEETING REQUEST.—The meeting request 

described in this clause is a request for a biosimilar 

biological product development meeting for a product. 

‘‘(iii) CLINICAL PROTOCOL FOR IND.—A clinical protocol for an investigational new drug protocol described 

in this clause is a clinical protocol consistent with 

the provisions of section 505(i), including any regulations promulgated under section 505(i), (referred to 

in this section as ‘investigational new drug application’) 

describing an investigation that the Secretary determines is intended to support a biosimilar biological 

product application for a product. 

‘‘(iv) DUE DATE.—The initial biosimilar biological 

product development fee shall be due by the earlier 

of the following: 

‘‘(I) Not later than 5 days after the Secretary 

grants a request for a biosimilar biological product 

development meeting. 

‘‘(II) The date of submission of an investigational new drug application describing an investigation that the Secretary determines is intended 
S. 3187—38 

to support a biosimilar biological product application. 

‘‘(v) TRANSITION RULE.—Each person that has submitted an investigational new drug application prior 

to the date of enactment of the Biosimilars User Fee 

Act of 2012 shall pay the initial biosimilar biological 

product development fee by the earlier of the following: 

‘‘(I) Not later than 60 days after the date 

of the enactment of the Biosimilars User Fee Act 

of 2012, if the Secretary determines that the investigational new drug application describes an investigation that is intended to support a biosimilar 

biological product application. 

‘‘(II) Not later than 5 days after the Secretary 

grants a request for a biosimilar biological product 

development meeting. 

‘‘(B) ANNUAL BIOSIMILAR BIOLOGICAL PRODUCT

DEVELOPMENT FEE.— 

‘‘(i) IN GENERAL.—A person that pays an initial 

biosimilar biological product development fee for a 

product shall pay for such product, beginning in the 

fiscal year following the fiscal year in which the initial 

biosimilar biological product development fee was paid, 

an annual fee established under subsection (b)(1)(B) 

for biosimilar biological product development (referred 

to in this section as ‘annual biosimilar biological 

product development fee’). 

‘‘(ii) DUE DATE.—The annual biosimilar biological 

product development program fee for each fiscal year 

will be due on the later of— 

‘‘(I) the first business day on or after October 

1 of each such year; or 

‘‘(II) the first business day after the enactment 

of an appropriations Act providing for the collection 

and obligation of fees for such year under this 

section. 

‘‘(iii) EXCEPTION.—The annual biosimilar development program fee for each fiscal year will be due 

on the date specified in clause (ii), unless the person 

has— 

‘‘(I) submitted a marketing application for the 

biological product that was accepted for filing; or 

‘‘(II) discontinued participation in the biosimilar biological product development program for 

the product under subparagraph (C). 

‘‘(C) DISCONTINUATION OF FEE OBLIGATION.—A person 

may discontinue participation in the biosimilar biological 

product development program for a product effective 

October 1 of a fiscal year by, not later than August 1 

of the preceding fiscal year— 

‘‘(i) if no investigational new drug application concerning the product has been submitted, submitting 

to the Secretary a written declaration that the person 

has no present intention of further developing the 

product as a biosimilar biological product; or 

‘‘(ii) if an investigational new drug application concerning the product has been submitted, withdrawing 
S. 3187—39 

the investigational new drug application in accordance 

with part 312 of title 21, Code of Federal Regulations 

(or any successor regulations). 

‘‘(D) REACTIVATION FEE.— 

‘‘(i) IN GENERAL.—A person that has discontinued 

participation in the biosimilar biological product 

development program for a product under subparagraph (C) shall pay a fee (referred to in this section 

as ‘reactivation fee’) by the earlier of the following: 

‘‘(I) Not later than 5 days after the Secretary 

grants a request for a biosimilar biological product 

development meeting for the product (after the 

date on which such participation was discontinued). 

‘‘(II) Upon the date of submission (after the 

date on which such participation was discontinued) 

of an investigational new drug application 

describing an investigation that the Secretary 

determines is intended to support a biosimilar 

biological product application for that product. 

‘‘(ii) APPLICATION OF ANNUAL FEE.—A person that 

pays a reactivation fee for a product shall pay for 

such product, beginning in the next fiscal year, the 

annual biosimilar biological product development fee 

under subparagraph (B). 

‘‘(E) EFFECT OF FAILURE TO PAY BIOSIMILAR DEVELOPMENT PROGRAM FEES.— 

‘‘(i) NO BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT MEETINGS.—If a person has failed to pay an 

initial or annual biosimilar biological product development fee as required under subparagraph (A) or (B), 

or a reactivation fee as required under subparagraph 

(D), the Secretary shall not provide a biosimilar 

biological product development meeting relating to the 

product for which fees are owed. 

‘‘(ii) NO RECEIPT OF INVESTIGATIONAL NEW DRUG

APPLICATIONS.—Except in extraordinary circumstances, 

the Secretary shall not consider an investigational new 

drug application to have been received under section 

505(i)(2) if— 

‘‘(I) the Secretary determines that the investigation is intended to support a biosimilar 

biological product application; and 

‘‘(II) the sponsor has failed to pay an initial 

or annual biosimilar biological product development fee for the product as required under 

subparagraph (A) or (B), or a reactivation fee as 

required under subparagraph (D). 

‘‘(iii) FINANCIAL HOLD.—Notwithstanding section 

505(i)(2), except in extraordinary circumstances, the 

Secretary shall prohibit the sponsor of a clinical investigation from continuing the investigation if— 

‘‘(I) the Secretary determines that the investigation is intended to support a biosimilar 

biological product application; and 
S. 3187—40 

‘‘(II) the sponsor has failed to pay an initial 

or annual biosimilar biological product development fee for the product as required under 

subparagraph (A) or (B), or a reactivation fee for 

the product as required under subparagraph (D). 

‘‘(iv) NO ACCEPTANCE OF BIOSIMILAR BIOLOGICAL

PRODUCT APPLICATIONS OR SUPPLEMENTS.—If a person 

has failed to pay an initial or annual biosimilar 

biological product development fee as required under 

subparagraph (A) or (B), or a reactivation fee as 

required under subparagraph (D), any biosimilar 

biological product application or supplement submitted 

by that person shall be considered incomplete and shall 

not be accepted for filing by the Secretary until all 

such fees owed by such person have been paid. 

‘‘(F) LIMITS REGARDING BIOSIMILAR DEVELOPMENT PROGRAM FEES.— 

‘‘(i) NO REFUNDS.—The Secretary shall not refund 

any initial or annual biosimilar biological product 

development fee paid under subparagraph (A) or (B), 

or any reactivation fee paid under subparagraph (D). 

‘‘(ii) NO WAIVERS, EXEMPTIONS, OR REDUCTIONS.— 

The Secretary shall not grant a waiver, exemption, 

or reduction of any initial or annual biosimilar 

biological product development fee due or payable 

under subparagraph (A) or (B), or any reactivation 

fee due or payable under subparagraph (D). 

‘‘(2) BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION AND

SUPPLEMENT FEE.— ‘‘(A) IN GENERAL.—Each person that submits, on or 

after October 1, 2012, a biosimilar biological product 

application or a supplement shall be subject to the following 

fees: 

‘‘(i) A fee for a biosimilar biological product application that is equal to— 

‘‘(I) the amount of the fee established under 

subsection (b)(1)(D) for a biosimilar biological 

product application 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) 
S. 3187—41 

with respect to safety or effectiveness are required, 

that is equal to half of the amount of the fee established 

under subsection (b)(1)(D) for a biosimilar biological 

product application. 

‘‘(B) REDUCTION IN FEES.—Notwithstanding section 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 DATE.—Any fee required by 

subparagraph (A) shall be due upon submission of the 

application or supplement for which such fee applies. 

‘‘(D) EXCEPTION FOR PREVIOUSLY FILED APPLICATION

OR SUPPLEMENT.—If a biosimilar biological product application or supplement was submitted by a person that paid 

the fee for such application or supplement, was accepted 

for filing, and was not approved or was withdrawn (without 

a waiver), the submission of a biosimilar biological product 

application or a supplement for the same product by the 

same person (or the person’s licensee, assignee, or successor) shall not be subject to a fee under subparagraph 

(A). 

‘‘(E) REFUND OF APPLICATION FEE IF APPLICATION

REFUSED FOR FILING OR WITHDRAWN BEFORE FILING.—The 

Secretary shall refund 75 percent of the fee paid under 

this paragraph for any application or supplement which 

is refused for filing or withdrawn without a waiver before 

filing. 

‘‘(F) FEES FOR APPLICATIONS PREVIOUSLY REFUSED FOR

FILING OR WITHDRAWN BEFORE FILING.—A biosimilar 

biological product application or supplement that was submitted but was refused for filing, or was withdrawn before 

being accepted or refused for filing, shall be subject to 

the full fee under subparagraph (A) upon being resubmitted 

or filed over protest, unless the fee is waived under subsection (c). 

‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT ESTABLISHMENT

FEE.— 

‘‘(A) IN GENERAL.—Except as provided in subparagraph 

(E), each person that is named as the applicant in a biosimilar biological product application shall be assessed an 

annual fee established under subsection (b)(1)(E) for each 

biosimilar biological product establishment that is listed 

in the approved biosimilar biological product application 

as an establishment that manufactures the biosimilar 

biological product named in such application. 

‘‘(B) ASSESSMENT IN FISCAL YEARS.—The establishment 

fee shall be assessed in each fiscal year for which the 

biosimilar biological product named in the application is 

assessed a fee under paragraph (4) unless the biosimilar 

biological product establishment listed in the application 
S. 3187—42 

does not engage in the manufacture of the biosimilar 

biological product during such fiscal year. 

‘‘(C) DUE DATE.—The establishment fee for a fiscal 

year shall be due on the later of— 

‘‘(i) the first business day on or after October 1 

of such fiscal year; or 

‘‘(ii) the first business day after the enactment 

of an appropriations Act providing for the collection 

and obligation of fees for such fiscal year under this 

section. 

‘‘(D) APPLICATION TO ESTABLISHMENT.— ‘‘(i) Each biosimilar biological product establishment shall be assessed only one fee per biosimilar 

biological product establishment, notwithstanding the 

number of biosimilar biological products manufactured 

at the establishment, subject to clause (ii). 

‘‘(ii) In the event an establishment is listed in 

a biosimilar biological product application by more than 

one applicant, the establishment fee for the fiscal year 

shall be divided equally and assessed among the 

applicants whose biosimilar biological products are 

manufactured by the establishment during the fiscal 

year and assessed biosimilar biological product fees 

under paragraph (4). 

‘‘(E) EXCEPTION FOR NEW PRODUCTS.—If, during the 

fiscal year, an applicant initiates or causes to be initiated 

the manufacture of a biosimilar biological product at an 

establishment listed in its biosimilar biological product 

application— 

‘‘(i) that did not manufacture the biosimilar 

biological product in the previous fiscal year; and 

‘‘(ii) for which the full biosimilar biological product 

establishment fee has been assessed in the fiscal year 

at a time before manufacture of the biosimilar 

biological product was begun, 

the applicant shall not be assessed a share of the biosimilar 

biological product establishment fee for the fiscal year in 

which the manufacture of the product began. 

‘‘(4) BIOSIMILAR BIOLOGICAL PRODUCT FEE.— 

‘‘(A) IN GENERAL.—Each person who is named as the 

applicant in a biosimilar biological product application shall 

pay for each such biosimilar biological product the annual 

fee established under subsection (b)(1)(F). 

‘‘(B) DUE DATE.—The biosimilar biological product fee 

for a fiscal year shall be due on the later of— 

‘‘(i) the first business day on or after October 1 

of each such year; or 

‘‘(ii) the first business day after the enactment 

of an appropriations Act providing for the collection 

and obligation of fees for such year under this section. 

‘‘(C) ONE FEE PER PRODUCT PER YEAR.—The biosimilar 

biological product fee shall be paid only once for each 

product for each fiscal year. 

‘‘(b) FEE SETTING AND AMOUNTS.— ‘‘(1) IN GENERAL.—Subject to paragraph (2), the Secretary 

shall, 60 days before the start of each fiscal year that begins 

after September 30, 2012, establish, for the next fiscal year, 
S. 3187—43 

the fees under subsection (a). Except as provided in subsection 

(c), such fees shall be in the following amounts: 

‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT FEE.—The initial biosimilar biological product 

development fee under subsection (a)(1)(A) for a fiscal year 

shall be equal to 10 percent of the amount established 

under section 736(c)(4) for a human drug application 

described in section 736(a)(1)(A)(i) for that fiscal year. 

‘‘(B) ANNUAL BIOSIMILAR BIOLOGICAL PRODUCT

DEVELOPMENT FEE.—The annual biosimilar biological 

product development fee under subsection (a)(1)(B) for a 

fiscal year shall be equal to 10 percent of the amount 

established under section 736(c)(4) for a human drug 

application described in section 736(a)(1)(A)(i) for that fiscal 

year. 

‘‘(C) REACTIVATION FEE.—The reactivation fee under 

subsection (a)(1)(D) for a fiscal year shall be equal to 20 

percent of the amount of the fee established under section 

736(c)(4) for a human drug application described in section 

736(a)(1)(A)(i) for that fiscal year. 

‘‘(D) BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION

FEE.—The biosimilar biological product application fee 

under subsection (a)(2) for a fiscal year shall be equal 

to the amount established under section 736(c)(4) for a 

human drug application described in section 736(a)(1)(A)(i) 

for that fiscal year. 

‘‘(E) BIOSIMILAR BIOLOGICAL PRODUCT ESTABLISHMENT

FEE.—The biosimilar biological product establishment fee 

under subsection (a)(3) for a fiscal year shall be equal 

to the amount established under section 736(c)(4) for a 

prescription drug establishment for that fiscal year. 

‘‘(F) BIOSIMILAR BIOLOGICAL PRODUCT FEE.—The biosimilar biological product fee under subsection (a)(4) for 

a fiscal year shall be equal to the amount established 

under section 736(c)(4) for a prescription drug product for 

that fiscal year. 

‘‘(2) LIMIT.—The total amount of fees charged for a fiscal 

year under this section may not exceed the total amount for 

such fiscal year of the costs of resources allocated for the 

process for the review of biosimilar biological product applications. 

‘‘(c) APPLICATION FEE WAIVER FOR SMALL BUSINESS.— 

‘‘(1) WAIVER OF APPLICATION FEE.—The Secretary shall 

grant to a person who is named in a biosimilar biological 

product application a waiver from the application fee assessed 

to that person under subsection (a)(2)(A) for the first biosimilar 

biological product application that a small business or its affiliate submits to the Secretary for review. After a small business 

or its affiliate is granted such a waiver, the small business 

or its affiliate shall pay— 

‘‘(A) application fees for all subsequent biosimilar 

biological product applications submitted to the Secretary 

for review in the same manner as an entity that is not 

a small business; and 

‘‘(B) all supplement fees for all supplements to biosimilar biological product applications submitted to the 
S. 3187—44 

Secretary for review in the same manner as an entity 

that is not a small business. 

‘‘(2) CONSIDERATIONS.—In determining whether to grant 

a waiver of a fee under paragraph (1), the Secretary shall 

consider only the circumstances and assets of the applicant 

involved and any affiliate of the applicant. 

‘‘(3) SMALL BUSINESS DEFINED.—In this subsection, the term 

‘small business’ means an entity that has fewer than 500 

employees, including employees of affiliates, and does not have 

a drug product that has been approved under a human drug 

application (as defined in section 735) or a biosimilar biological 

product application (as defined in section 744G(4)) and introduced or delivered for introduction into interstate commerce. 

‘‘(d) EFFECT OF FAILURE TO PAY FEES.—A biosimilar biological 

product application or supplement submitted by a person subject 

to fees under subsection (a) shall be considered incomplete and 

shall not be accepted for filing by the Secretary until all fees 

owed by such person have been paid. 

‘‘(e) CREDITING AND AVAILABILITY OF FEES.— 

‘‘(1) IN GENERAL.—Subject to paragraph (2), fees authorized 

under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance 

in appropriations Acts. Such fees are authorized to remain 

available until expended. Such sums as may be necessary may 

be transferred from the Food and Drug Administration salaries 

and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses 

with such fiscal year limitation. The sums transferred shall 

be available solely for the process for the review of biosimilar 

biological product applications. 

‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.— ‘‘(A) IN GENERAL.—Subject to subparagraphs (C) and 

(D), the fees authorized by this section shall be collected 

and available in each fiscal year in an amount not to 

exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year. 

‘‘(B) USE OF FEES AND LIMITATION.—The fees authorized by this section shall be available for a fiscal year 

beginning after fiscal year 2012 to defray the costs of 

the process for the review of biosimilar biological product 

applications (including such costs for an additional number 

of full-time equivalent positions in the Department of 

Health and Human Services to be engaged in such process), 

only if the Secretary allocates for such purpose an amount 

for such fiscal year (excluding amounts from fees collected 

under this section) no less than $20,000,000, multiplied 

by the adjustment factor applicable to the fiscal year 

involved. 

‘‘(C) FEE COLLECTION DURING FIRST PROGRAM YEAR.— Until the date of enactment of an Act making appropriations through September 30, 2013, for the salaries and 

expenses account of the Food and Drug Administration, 

fees authorized by this section for fiscal year 2013 may 

be collected and shall be credited to such account and 

remain available until expended. 

‘‘(D) PROVISION FOR EARLY PAYMENTS IN SUBSEQUENT

YEARS.—Payment of fees authorized under this section for 
S. 3187—45 

a fiscal year (after fiscal year 2013), prior to the due 

date for such fees, may be accepted by the Secretary in 

accordance with authority provided in advance in a prior 

year appropriations Act. 

‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of fiscal 

years 2013 through 2017, there is authorized to be appropriated 

for fees under this section an amount equivalent to the total 

amount of fees assessed for such fiscal year under this section. 

‘‘(f) COLLECTION OF UNPAID FEES.—In any case where the Secretary does not receive payment of a fee assessed under subsection 

(a) within 30 days after it is due, such fee shall be treated as 

a claim of the United States Government subject to subchapter 

II of chapter 37 of title 31, United States Code. 

‘‘(g) WRITTEN REQUESTS FOR WAIVERS AND REFUNDS.—To 

qualify for consideration for a waiver under subsection (c), or for 

a refund of any fee collected in accordance with subsection (a)(2)(A), 

a person shall submit to the Secretary a written request for such 

waiver or refund not later than 180 days after such fee is due. 

‘‘(h) CONSTRUCTION.—This section may not be construed to 

require that the number of full-time equivalent positions in the 

Department of Health and Human Services, for officers, employers, 

and advisory committees not engaged in the process of the review 

of biosimilar biological product applications, be reduced to offset 

the number of officers, employees, and advisory committees so 

engaged.’’. 

SEC. 403. REAUTHORIZATION; REPORTING REQUIREMENTS. 

Part 8 of subchapter C of chapter VII, as added by section 

402, is further amended by inserting after section 744H the following: 

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

‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal year 2013, 

not later than 120 days after the end of each fiscal year for which 

fees are collected under this part, the Secretary shall prepare and 

submit to the Committee on Energy and Commerce of the House 

of Representatives and the Committee on Health, Education, Labor, 

and Pensions of the Senate a report concerning the progress of 

the Food and Drug Administration in achieving the goals identified 

in the letters described in section 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 REPORT.—Not later than 120 days after the end 

of fiscal year 2013 and each subsequent fiscal year for which fees 

are collected under this part, the Secretary shall prepare and submit 

to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and 

Pensions of the Senate a report on the implementation of the 

authority for such fees during such fiscal year and the use, by 

the Food and Drug Administration, of the fees collected for such 

fiscal year. 

‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall make the 

reports required under subsections (a) and (b) available to the 
S. 3187—46 

public on the Internet Web site of the Food and Drug Administration. 

‘‘(d) STUDY.— ‘‘(1) IN GENERAL.—The Secretary shall contract with an 

independent accounting or consulting firm to study the workload volume and full costs associated with the process for 

the review of biosimilar biological product applications. 

‘‘(2) INTERIM RESULTS.—Not later than June 1, 2015, the 

Secretary shall publish, for public comment, interim results 

of the study described under paragraph (1). 

‘‘(3) FINAL RESULTS.—Not later than September 30, 2016, 

the Secretary shall publish, for public comment, the final results 

of the study described under paragraph (1). 

‘‘(e) REAUTHORIZATION.— 

‘‘(1) CONSULTATION.—In developing recommendations to 

present to the Congress with respect to the goals described 

in subsection (a), and plans for meeting the goals, for the 

process for the review of biosimilar biological product applications for the first 5 fiscal years after fiscal year 2017, and 

for the reauthorization of this part for such fiscal years, the 

Secretary shall consult with— 

‘‘(A) the Committee on Energy and Commerce of the 

House of Representatives; 

‘‘(B) the Committee on Health, Education, Labor, and 

Pensions of the Senate; 

‘‘(C) scientific and academic experts; 

‘‘(D) health care professionals; 

‘‘(E) representatives of patient and consumer advocacy 

groups; and 

‘‘(F) the regulated industry. 

‘‘(2) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotiations with the regulated industry, the Secretary shall— 

‘‘(A) present the recommendations developed under 

paragraph (1) to the congressional committees specified 

in such paragraph; 

‘‘(B) publish such recommendations in the Federal Register; 

‘‘(C) provide for a period of 30 days for the public 

to provide written comments on such recommendations; 

‘‘(D) hold a meeting at which the public may present 

its views on such recommendations; and 

‘‘(E) after consideration of such public views and comments, revise such recommendations as necessary. 

‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 

January 15, 2017, the Secretary shall transmit to the Congress 

the revised recommendations under paragraph (2), a summary 

of the views and comments received under such paragraph, 

and any changes made to the recommendations in response 

to such views and comments.’’. 

SEC. 404. SUNSET DATES. 

(a) AUTHORIZATION.—Sections 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 REQUIREMENTS.—Section 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. 
S. 3187—47 

SEC. 405. EFFECTIVE DATE. 

(a) IN GENERAL.—Except as provided under subsection (b), the 

amendments made by this title shall take effect on the later of— 

(1) October 1, 2012; or 

(2) the date of the enactment of this title. 

(b) EXCEPTION.—Fees under part 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. 

SEC. 406. SAVINGS CLAUSE. 

Notwithstanding the amendments made by this title, part 2 

of subchapter C of chapter VII of the Federal Food, Drug, and 

Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to 

human drug applications and supplements (as defined in such part 

as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2007, but before October 

1, 2012, with respect to assessing and collecting any fee required 

by such part for a fiscal year prior to fiscal year 2013. 

SEC. 407. CONFORMING AMENDMENT. 

Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amended by striking 

‘‘or (k)’’. 

SEC. 408. ADDITIONAL REPORTING REQUIREMENTS. 

Section 715, as added by section 308 of this Act, is amended 

by adding at the end the following: 

‘‘(b) BIOSIMILAR BIOLOGICAL PRODUCTS.— 

‘‘(1) IN GENERAL.—Beginning 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 INFORMATION.—As 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.’’. 

TITLE V—PEDIATRIC DRUGS AND 

DEVICES 

SEC. 501. PERMANENCE. 

(a) PEDIATRIC STUDIES OF DRUGS.—Section 505A (21 U.S.C. 

355a) is amended by striking subsection (q) (relating to a sunset). 
S. 3187—48 

(b) RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL

PRODUCTS.—Section 505B (21 U.S.C. 355c) is amended— 

(1) by striking subsection (m); and 

(2) by redesignating subsection (n) as subsection (m). 

SEC. 502. WRITTEN REQUESTS. 

(a) IN GENERAL.— (1) FEDERAL FOOD, DRUG, AND COSMETIC ACT.—Subsection 

(h) of section 505A (21 U.S.C. 355a) is amended to read as 

follows: 

‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH REQUIREMENTS.— 

Exclusivity 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 ACT.—Section 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) NEONATES.—Subparagraph (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.’’. 

SEC. 503. COMMUNICATION WITH PEDIATRIC REVIEW COMMITTEE. 

Not 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. 

SEC. 504. ACCESS TO DATA. 

Not 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)). 

SEC. 505. ENSURING THE COMPLETION OF PEDIATRIC STUDIES. 

(a) EXTENSION OF DEADLINE FOR DEFERRED STUDIES.—Section 

505B (21 U.S.C. 355c) is amended— 
S. 3187—49 

(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 GENERAL.—On 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 INFORMATION.—If 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 AVAILABILITY.—Not 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 
S. 3187—50 

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 INFORMATION.—Section 

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 LETTER.—Subsection (d) of section 505B 

(21 U.S.C. 355c) is amended to read as follows: 

‘‘(d) SUBMISSION OF ASSESSMENTS.—If 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 
S. 3187—51 

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 ISSUED.—Subparagraph (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;’’. 

SEC. 506. PEDIATRIC STUDY PLANS. 

(a) IN GENERAL.—Subsection (e) of section 505B (21 U.S.C. 

355c) is amended to read as follows: 

‘‘(e) PEDIATRIC STUDY PLANS.— ‘‘(1) IN GENERAL.—An 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) TIMING.—An 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 PLAN.—The 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) MEETING.—The Secretary— 
S. 3187—52 

‘‘(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 PLAN.—Not 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 WAIVER.—If 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 PLAN.—At 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 COMMITTEE.—The 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 RULEMAKING.—Not 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 AMENDMENTS.—Section 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,’’; 
S. 3187—53 

(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 ‘‘PEDI- ATRIC 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 GENERAL.—Subject 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 CONSTRUCTION.—Paragraph (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. 

SEC. 507. REAUTHORIZATIONS. 

(a) PEDIATRIC ADVISORY COMMITTEE.—Section 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 COMMITTEE.—Section 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 EXTENSION.—Section 

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 PHSA.— 

Section 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.’’. 

SEC. 508. REPORT. 

(a) IN GENERAL.—Not 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 
S. 3187—54 

implementation of sections 505A and 505B of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 355a, 355c). 

(b) CONTENTS.—Each 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 
S. 3187—55 

(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 COMMENT.—At 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. 

SEC. 509. TECHNICAL AMENDMENTS. 

(a) PEDIATRIC STUDIES OF DRUGS IN FFDCA.—Section 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 AUTHORITY.—Nothing 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)— 
S. 3187—56 

(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 FFDCA.—Section 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)— 
S. 3187—57 

(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 AUTHORITY.—Nothing 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 WAIVERS.— 

Section 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 DRUGS.—Section 

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

COMMITTEE.—Section 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 
S. 3187—58 

Law 110–85), is amended in paragraph (1)(D), by striking ‘‘section 

505B(f)’’ and inserting ‘‘section 505C’’. 

(f) FOUNDATION OF NATIONAL INSTITUTES OF HEALTH.—Section 

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) APPLICATION.—Notwithstanding 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 REPORTING.— With 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. 

SEC. 510. PEDIATRIC RARE DISEASES. 

(a) PUBLIC MEETING.—Not 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) REPORT.—Not 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. 

SEC. 511. STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS. 

Section 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 EXPERTISE.—For the 5-year period beginning 

on the date of enactment of this subsection, at least one of the 
S. 3187—59 

individuals described in subsection (c)(2) shall have expertise in 

neonatology.’’. 

TITLE VI—MEDICAL DEVICE 

REGULATORY IMPROVEMENTS 

SEC. 601. INVESTIGATIONAL DEVICE EXEMPTIONS. 

Section 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.’’. 

SEC. 602. CLARIFICATION OF LEAST BURDENSOME STANDARD. 

(a) PREMARKET APPROVAL.—Section 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.’’. 

SEC. 603. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT 

DECISIONS. 

Chapter V is amended by inserting after section 517 (21 U.S.C. 

360g) the following: 

‘‘SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT 

DECISIONS REGARDING DEVICES. 

‘‘(a) DOCUMENTATION OF RATIONALE FOR SIGNIFICANT

DECISIONS.— 
S. 3187—60 

‘‘(1) IN GENERAL.—The 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 DOCUMENTATION.—Upon 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

DECISION.—Any 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 REQUEST.—A 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 GENERAL.—Except 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) EXCEPTION.—Subparagraph (A) shall not apply 

in cases that are referred to experts outside of the Food 

and Drug Administration.’’. 

SEC. 604. DEVICE MODIFICATIONS REQUIRING PREMARKET NOTIFICATION PRIOR TO MARKETING. 

Section 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 
S. 3187—61 

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.’’. 

SEC. 605. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM. 

Chapter V is amended by inserting after section 518 (21 U.S.C. 

360h) the following: 

‘‘SEC. 518A. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM. 

‘‘(a) IN GENERAL.—The 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 CONTENT.—The program established under 

subsection (a)(1) shall, at a minimum, identify— 
S. 3187—62 

‘‘(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 RECALLS.—The Secretary shall document 

the basis for the termination by the Food and Drug Administration 

of a device recall. 

‘‘(d) DEFINITION.—In 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).’’. 

SEC. 606. CLINICAL HOLDS ON INVESTIGATIONAL DEVICE EXEMPTIONS. 

Section 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.’’. 

SEC. 607. MODIFICATION OF DE NOVO APPLICATION PROCESS. 

(a) IN GENERAL.—Section 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 
S. 3187—63 

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 AMENDMENTS.—Section 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).’’. 

SEC. 608. RECLASSIFICATION PROCEDURES. 

(a) CLASSIFICATION CHANGES.— 

(1) IN GENERAL.—Section 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— 
S. 3187—64 

‘‘(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 GENERAL.—The 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 PROVISIONS.—In 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 APPROVAL.—Section 515 (21 U.S.C. 360e) 

is amended— 

(A) in subsection (a), by striking ‘‘regulation promulgated under subsection (b)’’ and inserting ‘‘an order issued 
S. 3187—65 

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 
S. 3187—66 

(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 AMENDMENTS.—Section 

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 
S. 3187—67 

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 ENACT- MENT OF THIS ACT.—The 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) REPORTING.—The 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). 

SEC. 609. HARMONIZATION OF DEVICE PREMARKET REVIEW, INSPECTION, AND LABELING SYMBOLS. 

Paragraph (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.’’. 

SEC. 610. PARTICIPATION IN INTERNATIONAL FORA. 

Paragraph (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.’’. 

SEC. 611. REAUTHORIZATION OF THIRD-PARTY REVIEW. 

(a) PERIODIC REACCREDITATION.—Section 523(b)(2) (21 U.S.C. 

360m(b)(2)) is amended by adding at the end of the following: 

‘‘(E) PERIODIC REACCREDITATION.— 

‘‘(i) PERIOD.—Subject to suspension or withdrawal 

under subparagraph (B), any accreditation under this 
S. 3187—68 

section shall be valid for a period of 3 years after 

its issuance. 

‘‘(ii) RESPONSE TO REACCREDITATION REQUEST.— Upon 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) CRITERIA.—Not 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 AUTHORITY.—Section 523(c) (21 U.S.C. 

360m(c)) is amended by striking ‘‘October 1, 2012’’ and inserting 

‘‘October 1, 2017’’. 

SEC. 612. REAUTHORIZATION OF THIRD-PARTY INSPECTION. 

Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amended by striking 

‘‘October 1, 2012’’ and inserting ‘‘October 1, 2017’’. 

SEC. 613. HUMANITARIAN DEVICE EXEMPTIONS. 

(a) IN GENERAL.—Section 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.’’; 
S. 3187—69 

(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 DEVICES.—A 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. 

SEC. 614. UNIQUE DEVICE IDENTIFIER. 

Section 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.’’. 

SEC. 615. SENTINEL. 

Section 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 DEVICES.—The 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) EXCEPTION.—Subclause (II) of clause (i) of section 

505(k)(3)(C) shall not apply to devices. 

‘‘(C) CLARIFICATION.—With 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) DATA.—In 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. 
S. 3187—70 

‘‘(3) STAKEHOLDER INPUT.—To 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 SURVEYS.—Chapter 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.’’. 

SEC. 616. POSTMARKET SURVEILLANCE. 

Section 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. 

SEC. 617. CUSTOM DEVICES. 

Section 520(b) (21 U.S.C. 360j(b)) is amended to read as follows: 

‘‘(b) CUSTOM DEVICES.— ‘‘(1) IN GENERAL.—The 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 
S. 3187—71 

‘‘(G) may have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices. 

‘‘(2) LIMITATIONS.—Paragraph (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) GUIDANCE.—Not 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).’’. 

SEC. 618. HEALTH INFORMATION TECHNOLOGY. 

(a) REPORT.—Not 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 GENERAL.—In 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) REPRESENTATIVES.—If 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. 

SEC. 619. GOOD GUIDANCE PRACTICES RELATING TO DEVICES. 

Subparagraph (C) of section 701(h)(1) (21 U.S.C. 371(h)(1)) 

is amended— 
S. 3187—72 

(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.’’. 

SEC. 620. PEDIATRIC DEVICE CONSORTIA. 

(a) IN GENERAL.—Section 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 DEVICES.—The 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. 

TITLE VII—DRUG SUPPLY CHAIN 

SEC. 701. REGISTRATION OF DOMESTIC DRUG ESTABLISHMENTS. 

Section 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).’’. 
S. 3187—73 

SEC. 702. REGISTRATION OF FOREIGN ESTABLISHMENTS. 

(a) ENFORCEMENT OF REGISTRATION OF FOREIGN ESTABLISHMENTS.—Section 502(o) (21 U.S.C. 352(o)) is amended by striking 

‘‘in any State’’. 

(b) REGISTRATION OF FOREIGN DRUG ESTABLISHMENTS.—Section 

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.’’. 

SEC. 703. IDENTIFICATION OF DRUG EXCIPIENT INFORMATION WITH 

PRODUCT LISTING. 

Section 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: 
S. 3187—74 

‘‘(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.’’. 

SEC. 704. ELECTRONIC SYSTEM FOR REGISTRATION AND LISTING. 

Section 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 GENERAL.—Registrations and listings’’; and 

(2) by adding at the end the following: 

‘‘(2) ELECTRONIC DATABASE.—Not 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 COORDINATION.—The 

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).’’. 

SEC. 705. RISK-BASED INSPECTION FREQUENCY. 

Section 510(h) (21 U.S.C. 360(h)) is amended to read as follows: 

‘‘(h) INSPECTIONS.— 

‘‘(1) IN GENERAL.—Every 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 DEVICES.—Every 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. 
S. 3187—75 

‘‘(3) RISK-BASED SCHEDULE FOR DRUGS.—The 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 FACTORS.—In 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 STATUS.—In 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 ESTABLISHMENTS.—Beginning 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).’’. 

SEC. 706. RECORDS FOR INSPECTION. 

Section 704(a) (21 U.S.C. 374(a)) is amended by adding at 

the end the following: 
S. 3187—76 

‘‘(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.’’. 

SEC. 707. PROHIBITION AGAINST DELAYING, DENYING, LIMITING, OR 

REFUSING INSPECTION. 

(a) IN GENERAL.—Section 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) GUIDANCE.—Not 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)). 

SEC. 708. DESTRUCTION OF ADULTERATED, MISBRANDED, OR 

COUNTERFEIT DRUGS OFFERED FOR IMPORT. 

(a) IN GENERAL.—The 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) NOTICE.—Subsection (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 
S. 3187—77 

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) APPLICABILITY.—The 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 GENERAL.—Not 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) PROCEDURE.—In 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) RESTRICTIONS.—Notwithstanding 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). 

SEC. 709. ADMINISTRATIVE DETENTION. 

(a) IN GENERAL.—Section 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 GENERAL.—Not 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 GENERAL.—Section 304 (21 U.S.C. 334) is amended 

by adding at the end the following: 

‘‘(i) PROCEDURES FOR PROMULGATING REGULATIONS.— 

‘‘(1) IN GENERAL.—In 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 
S. 3187—78 

‘‘(C) publish the final regulation not less than 30 days 

before the regulation’s effective date. 

‘‘(2) RESTRICTIONS.—Notwithstanding any other provision 

of Federal law, in implementing this section, the Secretary 

shall only promulgate regulations as described in paragraph 

(1).’’. 

(c) EFFECTIVE DATE.—The amendments made by subsection 

(a) shall not take effect until the Secretary has issued a final 

regulation under subsection (b). 

SEC. 710. EXCHANGE OF INFORMATION. 

Section 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: 

‘‘SEC. 708. CONFIDENTIAL INFORMATION. 

‘‘(a) CONTRACTORS.—The Secretary may provide’’; and 

(2) by adding at the end the following: 

‘‘(b) ABILITY TO RECEIVE AND PROTECT CONFIDENTIAL INFORMA- TION OBTAINED FROM FOREIGN GOVERNMENTS.— ‘‘(1) IN GENERAL.—The 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 LIMITATIONS.—The 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 AFFECTED.—Nothing 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 LAW.—For 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. 
S. 3187—79 

‘‘(c) AUTHORITY TO ENTER INTO MEMORANDA OF UNDER- STANDING FOR PURPOSES OF INFORMATION EXCHANGE.—The Secretary may enter into written agreements to provide information 

referenced in section 301(j) to foreign governments subject to the 

following criteria: 

‘‘(1) CERTIFICATION.—The 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 AGREEMENT.—The 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 EXCHANGE.—The 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 SUBSECTION.—Nothing 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.’’. 

SEC. 711. ENHANCING THE SAFETY AND QUALITY OF THE DRUG 

SUPPLY. 

Section 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.’’. 
S. 3187—80 

SEC. 712. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS. 

Chapter VIII (21 U.S.C. 381 et seq.) is amended by adding 

at the end the following: 

‘‘SEC. 809. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS. 

‘‘(a) INSPECTION.—The 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 INSPECTION.—The 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.’’. 

SEC. 713. STANDARDS FOR ADMISSION OF IMPORTED DRUGS. 

Section 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. 
S. 3187—81 

‘‘(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).’’. 

SEC. 714. REGISTRATION OF COMMERCIAL IMPORTERS. 

(a) PROHIBITIONS.—Section 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) REGISTRATION.—Section 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) REGISTRATION.—The 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 GENERAL.—The Secretary, in consultation with 

the Secretary of Homeland Security acting through U.S. 
S. 3187—82 

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) PROCEDURE.—In 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) RESTRICTIONS.—Notwithstanding any other provision of Federal law, in implementing this subsection, the 

Secretary shall only promulgate regulations as described 

in subparagraph (B). 

‘‘(3) DISCONTINUANCE OF REGISTRATION.—The 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 IDENTIFIER.—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. 

‘‘(5) EXEMPTIONS.—The Secretary, by notice in the Federal 

Register, may establish exemptions from the requirements of 

this subsection.’’. 

(c) MISBRANDING.—Section 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 GENERAL.—Not 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 GENERAL.—In 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) RESTRICTIONS.—Notwithstanding 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). 
S. 3187—83 

(3) EFFECTIVE DATE.—In 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. 

SEC. 715. NOTIFICATION. 

(a) PROHIBITED ACTS.—Section 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) NOTIFICATION.—Subchapter E of chapter V (21 U.S.C. 

360bbb et seq.) is amended by adding at the end the following: 

‘‘SEC. 568. NOTIFICATION. 

‘‘(a) NOTIFICATION TO SECRETARY.—With 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 NOTIFICATION.—Notification under this section 

shall be made in such manner and by such means as the Secretary 

may specify by regulation or guidance. 

‘‘(c) SAVINGS CLAUSE.—Nothing 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) DEFINITION.—In 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.’’. 

SEC. 716. PROTECTION AGAINST INTENTIONAL ADULTERATION. 

Section 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 
S. 3187—84 

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.’’. 

SEC. 717. PENALTIES FOR COUNTERFEITING DRUGS. 

(a) COUNTERFEIT DRUG PENALTY ENHANCEMENT.— 

(1) OFFENSE.—Section 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) PENALTIES.—Section 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) DEFINITION.—Section 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

PROSECUTIONS.—The 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 COMMISSION.—Pursuant 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) REQUIREMENTS.—In 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; 
S. 3187—85 

(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. 

SEC. 718. EXTRATERRITORIAL JURISDICTION. 

Chapter III (21 U.S.C. 331 et seq.) is amended by adding 

at the end the following: 

‘‘SEC. 311. EXTRATERRITORIAL JURISDICTION. 

‘‘There 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.’’. 

TITLE VIII—GENERATING ANTIBIOTIC 

INCENTIVES NOW 

SEC. 801. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS. 

(a) IN GENERAL.—Chapter V (21 U.S.C. 351 et seq.) is amended 

by inserting after section 505D the following: 

‘‘SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW QUALIFIED 

INFECTIOUS DISEASE PRODUCTS. 

‘‘(a) EXTENSION.—If 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 EXCLUSIVITY.—Any 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) LIMITATIONS.—Subsection (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 GENERAL.—The manufacturer or sponsor of a drug 

may request the Secretary to designate a drug as a qualified 
S. 3187—86 

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) LIMITATION.—Except 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 DESIGNATION.—The 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 GENERAL.—Not 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) PROCEDURE.—In 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) RESTRICTIONS.—Notwithstanding 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 REGULATIONS.—The 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) DEFINITION.—In 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, vancomycinresistant 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 GENERAL.—The Secretary shall establish and 

maintain a list of qualifying pathogens, and shall make 

public the methodology for developing such list. 
S. 3187—87 

‘‘(B) CONSIDERATIONS.—In 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) REVIEW.—Every 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 PRODUCT.—The term 

‘qualified infectious disease product’ means an antibacterial or 

antifungal drug for human use intended to treat serious or lifethreatening 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) APPLICATION.—Section 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. 

SEC. 802. PRIORITY REVIEW. 

(a) AMENDMENT.—Chapter V (21 U.S.C. 351 et seq.) is amended 

by inserting after section 524 the following: 

‘‘SEC. 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) APPLICATION.—Section 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. 

SEC. 803. FAST TRACK PRODUCT. 

Section 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. 
S. 3187—88 

SEC. 804. CLINICAL TRIALS. 

(a) REVIEW AND REVISION OF GUIDANCE DOCUMENTS.— 

(1) IN GENERAL.—The 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 REVIEW.—At 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 CONSTRUCTION.—Except 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) REQUEST.—The 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) RECOMMENDATIONS.—If 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 PRODUCT.—For 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. 

SEC. 805. REASSESSMENT OF QUALIFIED INFECTIOUS DISEASE 

PRODUCT INCENTIVES IN 5 YEARS. 

(a) IN GENERAL.—Not 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 
S. 3187—89 

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) DEFINITION.—For 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. 
S. 3187—90 

SEC. 806. GUIDANCE ON PATHOGEN-FOCUSED ANTIBACTERIAL DRUG 

DEVELOPMENT. 

(a) DRAFT GUIDANCE.—Not 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 GUIDANCE.—Not 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. 

TITLE IX—DRUG APPROVAL AND 

PATIENT ACCESS 

SEC. 901. ENHANCEMENT OF ACCELERATED PATIENT ACCESS TO NEW 

MEDICAL TREATMENTS. 

(a) FINDINGS; SENSE OF CONGRESS.— (1) FINDINGS.—Congress 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 lifethreatening 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 
S. 3187—91 

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 CONGRESS.—It 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 lifethreatening diseases or conditions while maintaining safety 

and effectiveness standards for such treatments. 

(b) EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFETHREATENING DISEASES OR CONDITIONS.—Section 506 (21 U.S.C. 

356) is amended to read as follows: 

‘‘SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFETHREATENING DISEASES OR CONDITIONS. 

‘‘(a) DESIGNATION OF DRUG AS FAST TRACK PRODUCT.— ‘‘(1) IN GENERAL.—The 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 DESIGNATION.—The 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) DESIGNATION.—Within 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 APPROVAL.—The Secretary may 

approve an application for approval of a product for a 
S. 3187—92 

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) EVIDENCE.—The 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) LIMITATION.—Approval 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 APPROVAL.—The 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 GENERAL.—If 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 
S. 3187—93 

‘‘(B) pays any fee that may be required under section 

736. 

‘‘(2) EXCEPTION.—Any 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 EFFORTS.—The 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) PURPOSE.—The 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) CONSTRUCTION.—Nothing 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 wellcontrolled 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 GUIDANCE.—Not 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. 
S. 3187—94 

(2) FINAL GUIDANCE.—Not 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) CONSIDERATION.—In 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 CHANGES.—The 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 REQUESTS.—The 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 REVIEW.—The 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. 

SEC. 902. BREAKTHROUGH THERAPIES. 

(a) IN GENERAL.—Section 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 GENERAL.—The 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 
S. 3187—95 

development. (In this section, such a drug is referred to as 

a ‘breakthrough therapy’.) 

‘‘(2) REQUEST FOR DESIGNATION.—The 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 GENERAL.—Not 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) ACTIONS.—The 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, crossdisciplinary 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) GUIDANCE.—Not 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. 
S. 3187—96 

(B) AMENDED REGULATIONS.— (i) IN GENERAL.—If 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) PROCEDURE.—In 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) RESTRICTIONS.—Notwithstanding any other 

provision of law, the Secretary shall promulgate regulations implementing the amendments made by this section only as described in clause (ii). 

(2) REQUIREMENTS.—Guidance 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 AMENDMENTS.—Section 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)’’. 

SEC. 903. CONSULTATION WITH EXTERNAL EXPERTS ON RARE DISEASES, TARGETED THERAPIES, AND GENETIC TARGETING 

OF TREATMENTS. 

Subchapter 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: 

‘‘SEC. 569. CONSULTATION WITH EXTERNAL EXPERTS ON RARE DISEASES, TARGETED THERAPIES, AND GENETIC TARGETING 

OF TREATMENTS. 

‘‘(a) IN GENERAL.—For 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 STAKEHOLDERS.—Consistent 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.— 
S. 3187—97 

‘‘(A) IN GENERAL.—The 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 EXPERTS.—For 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 CONSULTATION.—Topics 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 EMPLOYEES.— The 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 CONSTRUCTION.—Nothing 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 DISCLOSURE.—The 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 CONSULTATION.—Nothing 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.— 
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‘‘(1) NO RIGHT TO CONSULTATION.—Nothing 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 GOALS.—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. 

‘‘(3) NO CHANGE TO NUMBER OF REVIEW CYCLES.—Nothing 

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 GENERAL.—Prior 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) LIMITATION.—The 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.’’. 

SEC. 904. ACCESSIBILITY OF INFORMATION ON PRESCRIPTION DRUG 

CONTAINER LABELS BY VISUALLY IMPAIRED AND BLIND 

CONSUMERS. 

(a) ESTABLISHMENT OF WORKING GROUP.— 

(1) IN GENERAL.—The 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) MEMBERS.—The 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 GENERAL.—The 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 
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blind and visually impaired individuals have safe, consistent, reliable, and independent access to the information 

on prescription drug container labels. 

(B) PUBLIC AVAILABILITY.—The 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) LIMITATIONS.—The 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) CONSIDERATIONS.—In 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 CAMPAIGN.—Upon 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 WAIVER.—The Federal Advisory Committee Act 

(5 U.S.C. App.) shall not apply to the working group. 

(b) GAO STUDY.— (1) IN GENERAL.—Beginning 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 
S. 3187—100 

best practices, and the extent to which barriers to accessible 

information on prescription drug container labels for blind and 

visually impaired individuals continue. 

(2) REPORT.—Not 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) DEFINITIONS.—In 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. 

SEC. 905. RISK-BENEFIT FRAMEWORK. 

Section 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.’’. 

SEC. 906. GRANTS AND CONTRACTS FOR THE DEVELOPMENT OF 

ORPHAN DRUGS. 

(a) QUALIFIED TESTING DEFINITION.—Section 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 APPROPRIATIONS.—Section 5(c) of the 

Orphan Drug Act (21 U.S.C. 360ee(c)) is amended to read as follows: 

‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For grants and contracts under subsection (a), there is authorized to be appropriated 

$30,000,000 for each of fiscal years 2013 through 2017.’’. 

SEC. 907. REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS 

IN CLINICAL TRIALS AND DATA ANALYSIS IN APPLICATIONS FOR DRUGS, BIOLOGICS, AND DEVICES. 

(a) REPORT.— 

(1) IN GENERAL.—Not 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 
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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 REPORT.—The 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 GENERAL.—Not 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 PLAN.—The 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; 
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(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) DEFINITIONS.—In 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. 

SEC. 908. RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER 

INCENTIVE PROGRAM. 

Subchapter B of chapter V (21 U.S.C. 360aa et seq.) is amended 

by adding at the end the following: 

‘‘SEC. 529. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR RARE 

PEDIATRIC DISEASES. 

‘‘(a) DEFINITIONS.—In this section: 

‘‘(1) PRIORITY REVIEW.—The 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 VOUCHER.—The 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 DISEASE.—The 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 APPLICATION.—The 

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— 
S. 3187—103 

‘‘(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 GENERAL.—The 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 GENERAL.—The 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 TRANSFER.—Each 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) LIMITATION.—A 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 GENERAL.—The 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 NOTICE.—The 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 
S. 3187—104 

has not yet submitted the human drug application 

described in the notification. 

‘‘(5) TERMINATION OF AUTHORITY.—The 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 GENERAL.—The 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 AMOUNT.—The 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 SETTING.—The 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 GENERAL.—The 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 APPLICATION.—An 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

REFUNDS.—The Secretary may not grant a waiver, exemption, reduction, or refund of any fees due and payable 

under this section. 

‘‘(5) OFFSETTING COLLECTIONS.—Fees 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 GENERAL.—Upon the request of the manufacturer 

or the sponsor of a new drug, the Secretary may designate— 
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‘‘(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 DESIGNATION.—The 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 SECRETARY.—Not 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) REVOCATION.—The 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 REPORT.—The 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 VOUCHER.—The 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) NOTIFICATION.—If, 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 
S. 3187—106 

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 PROGRAMS.—Nothing 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 PROVISIONS.—The 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 GENERAL.—Beginning 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 STUDY.—In 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) REPORT.—Not 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).’’. 
S. 3187—107 

TITLE X—DRUG SHORTAGES 

SEC. 1001. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION 

OF LIFE-SAVING DRUGS. 

(a) IN GENERAL.—Section 506C (21 U.S.C. 356c) is amended 

to read as follows: 

‘‘SEC. 506C. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF LIFE-SAVING DRUGS. 

‘‘(a) IN GENERAL.—A 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) TIMING.—A 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) DISTRIBUTION.—To 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) CONFIDENTIALITY.—Nothing 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 GENERAL.—Not 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 
S. 3187—108 

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 REQUIREMENTS.—If 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 REVIEWS.—If, 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) DEFINITIONS.—For 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’— 
S. 3187—109 

‘‘(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 GENERAL.—Not 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) CONTENTS.—Such 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 GENERAL.—The 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 VACCINES.—If 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) PROCEDURE.—In 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) RESTRICTIONS.—Notwithstanding any other provision 

of Federal law, in implementing this section, the Secretary 

shall only promulgate regulations as described in paragraph 

(4).’’. 

(b) EFFECT OF NOTIFICATION.—The 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— 
S. 3187—110 

(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. 

SEC. 1002. ANNUAL REPORTING ON DRUG SHORTAGES. 

Chapter 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: 

‘‘SEC. 506C–1. ANNUAL REPORTING ON DRUG SHORTAGES. 

‘‘(a) ANNUAL REPORTS TO CONGRESS.—Not 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 ANALYSIS.—The 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) DEFINITION.—In this section, the term ‘drug shortage’ or 

‘shortage’ has the meaning given such term in section 506C.’’. 
S. 3187—111 

SEC. 1003. COORDINATION; TASK FORCE AND STRATEGIC PLAN. 

Chapter 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: 

‘‘SEC. 506D. COORDINATION; TASK FORCE AND STRATEGIC PLAN. 

‘‘(a) TASK FORCE AND STRATEGIC PLAN.— 

‘‘(1) IN GENERAL.— 

‘‘(A) TASK FORCE.—As 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 PLAN.—The strategic plan described 

in subparagraph (A) shall include— 

‘‘(i) plans for enhanced interagency and intraagency 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 PROGRAM.—In 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) CONSULTATION.—In 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 
S. 3187—112 

and Human Services with expertise regarding drug shortages. The Secretary shall engage external stakeholders and 

experts as appropriate. 

‘‘(2) TIMING.—Not 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) COMMUNICATION.—The 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) ACTION.—If 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 ENTITIES.—The 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 CONSTRUCTION.—No 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) SUNSET.—Subsections (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.’’. 

SEC. 1004. DRUG SHORTAGE LIST. 

Chapter 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: 

‘‘SEC. 506E. DRUG SHORTAGE LIST. 

‘‘(a) ESTABLISHMENT.—The Secretary shall maintain an up-todate list of drugs that are determined by the Secretary to be 

in shortage in the United States. 

‘‘(b) CONTENTS.—For 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. 
S. 3187—113 

‘‘(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 GENERAL.—Subject to paragraphs (2) and (3), the 

Secretary shall make the information in such list publicly available. 

‘‘(2) TRADE SECRETS AND CONFIDENTIAL INFORMATION.— Nothing 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 EXCEPTION.—The 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).’’. 

SEC. 1005. QUOTAS APPLICABLE TO DRUGS IN SHORTAGE. 

Section 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.’’. 

SEC. 1006. ATTORNEY GENERAL REPORT ON DRUG SHORTAGES. 

Not 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, 
S. 3187—114 

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. 

SEC. 1007. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE. 

Chapter 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: 

‘‘SEC. 506F. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE. 

‘‘(a) DEFINITIONS.—In this section: 

‘‘(1) DRUG.—The term ‘drug’ excludes any controlled substance (as such term is defined in section 102 of the Controlled 

Substances Act). 

‘‘(2) HEALTH SYSTEM.—The 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) REPACKAGE.—For 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 REGISTRATION.—Notwithstanding 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) CONDITIONS.—Subsection (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 ONLY.—In 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 RULES.—Repackaging 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) TERMINATION.—This 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 
S. 3187—115 

pharmacies repackaging and safely transferring repackaged drugs 

to other hospitals within the same health system during a drug 

shortage.’’. 

SEC. 1008. STUDY ON DRUG SHORTAGES. 

(a) STUDY.—The 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) CONSIDERATION.—In 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 
S. 3187—116 

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 STAKEHOLDERS.—In 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) REPORT.—Not 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. 

TITLE XI—OTHER PROVISIONS 

Subtitle A—Reauthorizations 

SEC. 1101. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE 

ENANTIOMERS. 

(a) IN GENERAL.—Section 505(u)(4) (21 U.S.C. 355(u)(4)) is 

amended by striking ‘‘2012’’ and inserting ‘‘2017’’. 

(b) AMENDMENT.—Section 505(u)(1)(A)(ii)(II) (21 U.S.C. 

355(u)(1)(A)(ii)(II)) is amended by inserting ‘‘clinical’’ after ‘‘any’’. 

SEC. 1102. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS. 

Subsection (f) of section 566 (21 U.S.C. 360bbb–5) is amended 

to read as follows: 

‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there is authorized to be appropriated $6,000,000 for each 

of fiscal years 2013 through 2017.’’. 

Subtitle B—Medical Gas Product 

Regulation 

SEC. 1111. REGULATION OF MEDICAL GASES. 

Chapter V (21 U.S.C. 351 et seq.) is amended by adding at 

the end the following: 

‘‘Subchapter G—Medical Gases 

‘‘SEC. 575. DEFINITIONS. 

‘‘In 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. 
S. 3187—117 

‘‘(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. 

‘‘SEC. 576. REGULATION OF MEDICAL GASES. 

‘‘(a) CERTIFICATION OF DESIGNATED MEDICAL GASES.— 

‘‘(1) SUBMISSION.—Beginning 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 CERTIFICATION.—The 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 USES.—A 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: 
S. 3187—118 

‘‘(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) LABELING.—The 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

GAS.—No 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 CERTIFICATION.—No 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 APPROVAL.—Nothing 

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 
S. 3187—119 

have in effect an approved application under section 505 

or section 512 of this Act. 

‘‘(B) REVOCATION OF CERTIFICATION.—The 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 GENERAL.—A 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 USES.— 

Notwithstanding 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) LABELING.—For 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. 

‘‘SEC. 577. INAPPLICABILITY OF DRUG FEES TO DESIGNATED MEDICAL 

GASES. 

‘‘A 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.’’. 

SEC. 1112. CHANGES TO REGULATIONS. 

(a) REPORT.—Not 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) REGULATIONS.—If 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) DEFINITIONS.—In this section: 
S. 3187—120 

(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. 

SEC. 1113. RULES OF CONSTRUCTION. 

Nothing 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. 

Subtitle C—Miscellaneous Provisions 

SEC. 1121. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION 

USING THE INTERNET. 

Not 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. 

SEC. 1122. COMBATING PRESCRIPTION DRUG ABUSE. 

(a) IN GENERAL.—To 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) REPORT.—Not 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 
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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 PRODUCTS.—Not 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. 

SEC. 1123. OPTIMIZING GLOBAL CLINICAL TRIALS. 

Subchapter 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: 

‘‘SEC. 569A. OPTIMIZING GLOBAL CLINICAL TRIALS. 

‘‘(a) IN GENERAL.—The 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 PRODUCT.—In 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 CLAUSE.—Nothing in this section shall alter the 

criteria for evaluating the safety or effectiveness of a medical 

product under this Act. 

‘‘SEC. 569B. USE OF CLINICAL INVESTIGATION DATA FROM OUTSIDE 

THE UNITED STATES. 

‘‘(a) IN GENERAL.—In 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 
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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 SPONSOR.—If 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.’’. 

SEC. 1124. ADVANCING REGULATORY SCIENCE TO PROMOTE PUBLIC 

HEALTH INNOVATION. 

(a) IN GENERAL.—Not 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) REQUIREMENTS.—The 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 
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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 REPORTS.—The 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 PRODUCT.—In 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. 

SEC. 1125. INFORMATION TECHNOLOGY. 

(a) HHS REPORT.—Not 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; 
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(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 REPORT.—Not 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. 

SEC. 1126. NANOTECHNOLOGY. 

(a) IN GENERAL.—The 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) ACTIVITIES.—In conducting activities related to nanotechnology, the Secretary may— 
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(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). 

SEC. 1127. ONLINE PHARMACY REPORT TO CONGRESS. 

Not 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; 
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(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. 

SEC. 1128. REPORT ON SMALL BUSINESSES. 

Not 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. 

SEC. 1129. PROTECTIONS FOR THE COMMISSIONED CORPS OF THE 

PUBLIC HEALTH SERVICE ACT. 

(a) IN GENERAL.—Section 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 AMENDMENT.—Section 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.’’. 
S. 3187—127 

SEC. 1130. COMPLIANCE DATE FOR RULE RELATING TO SUNSCREEN 

DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE. 

In 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. 

SEC. 1131. STRATEGIC INTEGRATED MANAGEMENT PLAN. 

Not 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.). 

SEC. 1132. ASSESSMENT AND MODIFICATION OF REMS. 

(a) ASSESSMENT AND MODIFICATION OF APPROVED STRATEGY.— Section 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,’’; 
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(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 PERSON.—After 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 SECRETARY.—After 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 STRATEGIES.—Section 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)— 
S. 3187—129 

(A) by amending subparagraph (A) to read as follows: 

‘‘(A) IN GENERAL.— 

‘‘(i) TIMEFRAME.—Unless 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 MODIFICATIONS.—The 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

CHANGES.—Not 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) GUIDANCE.—The 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 AVAILABILITY.—Upon 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)— 
S. 3187—130 

(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) GUIDANCE.—Not 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. 

SEC. 1133. EXTENSION OF PERIOD FOR FIRST APPLICANT TO OBTAIN 

TENTATIVE APPROVAL WITHOUT FORFEITING 180-DAYEXCLUSIVITY PERIOD. 

(a) EXTENSION.— 

(1) IN GENERAL.—If 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 AMENDMENT.—In 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

APPLICATIONS.—If 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) DEFINITIONS.—For 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)). 
S. 3187—131 

SEC. 1134. DEADLINE FOR DETERMINATION ON CERTAIN PETITIONS. 

(a) IN GENERAL.—Section 505 (21 U.S.C. 355) is amended by 

adding at the end the following: 

‘‘(w) DEADLINE FOR DETERMINATION ON CERTAIN PETITIONS.— The 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) APPLICATION.—The 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. 

SEC. 1135. FINAL AGENCY ACTION RELATING TO PETITIONS AND CIVIL 

ACTIONS. 

Section 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’’. 

SEC. 1136. ELECTRONIC SUBMISSION OF APPLICATIONS. 

Subchapter D of chapter VII (21 U.S.C. 379k et seq.) is amended 

by inserting after section 745 the following: 

‘‘SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS. 

‘‘(a) DRUGS AND BIOLOGICS.— 

‘‘(1) IN GENERAL.—Beginning no earlier than 24 months 

after the issuance of a final guidance issued after public notice 

and opportunity for comment, submissions under 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. 
S. 3187—132 

‘‘(2) GUIDANCE CONTENTS.—In 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) EXCEPTION.—This subsection shall not apply to submissions described in section 561. 

‘‘(b) DEVICES.— ‘‘(1) IN GENERAL.—Beginning 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 CONTENTS.—In 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.’’. 

SEC. 1137. PATIENT PARTICIPATION IN MEDICAL PRODUCT DISCUSSIONS. 

Subchapter 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: 

‘‘SEC. 569C. PATIENT PARTICIPATION IN MEDICAL PRODUCT DISCUSSION. 

‘‘(a) IN GENERAL.—The 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 INFORMATION.—Nothing 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 CONSULTATION.—Nothing 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 OBLIGATION.—Nothing 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 
S. 3187—133 

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 INTEREST.—In this section, the term ‘financial 

interest’ means a financial interest under section 208(a) of title 

18, United States Code.’’. 

SEC. 1138. ENSURING ADEQUATE INFORMATION REGARDING PHARMACEUTICALS FOR ALL POPULATIONS, PARTICULARLY 

UNDERREPRESENTED SUBPOPULATIONS, INCLUDING 

RACIAL SUBGROUPS. 

(a) COMMUNICATION PLAN.—The 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) CONTENT.—The 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 PLAN.—Not 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 SITE.—The 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 
S. 3187—134 

provide links to any other appropriate Internet Web site, and 

seek public comment on the communication plan. 

SEC. 1139. SCHEDULING OF HYDROCODONE. 

(a) IN GENERAL.—Not 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 INPUT.—In 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) TRANSCRIPT.—The transcript of any public meeting conducted pursuant to this section shall be published on the Internet 

Web site of the Food and Drug Administration. 

SEC. 1140. STUDY ON DRUG LABELING BY ELECTRONIC MEANS. 

(a) STUDY.—The 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) REPORT.—Not 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). 

SEC. 1141. RECOMMENDATIONS ON INTEROPERABILITY STANDARDS. 

(a) IN GENERAL.—The 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) REQUIREMENTS.—The 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; 
S. 3187—135 

(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 GENERAL.—Not 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) CONTENTS.—The 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. 

SEC. 1142. CONFLICTS OF INTEREST. 

(a) IN GENERAL.—Section 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 GENERAL.—The 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; 
S. 3187—136 

‘‘(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 ACTIVITIES.—The 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) EXPERTISE.—In 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 CERTIFICATIONS.— Notwithstanding section 107(a)(2) of the Ethics in Government Act 

of 1978, the following shall apply: 

‘‘(1) 15 OR MORE DAYS IN ADVANCE.—As 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 ADVANCE.—In the case of a 

financial interest that becomes known to the Secretary less 

than 30 days prior to a meeting of an advisory committee 
S. 3187—137 

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 GENERAL.—Not 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 AVAILABILITY.—Not 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 
S. 3187—138 

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 INVOLVEMENT.—The 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) APPLICABILITY.—The amendments made by subsection (a) 

apply beginning on October 1, 2012. 

SEC. 1143. NOTIFICATION OF FDA INTENT TO REGULATE LABORATORYDEVELOPED TESTS. 

(a) IN GENERAL.—The Food and Drug Administration may not 

issue any draft or final guidance on the regulation of laboratorydeveloped 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) SUNSET.—Subsection (a) shall cease to have force or effect 

on the date that is 5 years after the date of enactment of this 

Act. 

Subtitle D—Synthetic Drugs 

SEC. 1151. SHORT TITLE. 

This subtitle may be cited as the ‘‘Synthetic Drug Abuse Prevention Act of 2012’’. 

SEC. 1152. ADDITION OF SYNTHETIC DRUGS TO SCHEDULE I OF THE 

CONTROLLED SUBSTANCES ACT. 

(a) CANNABIMIMETIC AGENTS.—Schedule 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. 
S. 3187—139 

‘‘(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 DRUGS.—Schedule 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). 
S. 3187—140 

‘‘(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).’’. 

SEC. 1153. TEMPORARY SCHEDULING TO AVOID IMMINENT HAZARDS 

TO PUBLIC SAFETY EXPANSION. 

Section 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.