Food and Drug Administration Safety and Innovation Act
PL 112-144 (S.3187), enacted 07/09/2012

126 STAT. 993 
PUBLIC LAW 112–144—JULY 9, 2012 
Public Law 112–144 
112th Congress 
An Act 
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the 
user-fee programs for prescription drugs and medical devices, to establish user- 
fee programs for generic drugs and biosimilars, and for other purposes. 
Be it enacted by the Senate and House of Representatives of 
the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Food and Drug Administration 
Safety and Innovation Act’’. 
SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT. 
(a) TABLE OF CONTENTS.—The table of contents of this Act 
is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents; references in Act. 
TITLE I—FEES RELATING TO DRUGS 
Sec. 101. Short title; finding. 
Sec. 102. Definitions. 
Sec. 103. Authority to assess and use drug fees. 
Sec. 104. Reauthorization; reporting requirements. 
Sec. 105. Sunset dates. 
Sec. 106. Effective date. 
Sec. 107. Savings clause. 
TITLE II—FEES RELATING TO DEVICES 
Sec. 201. Short title; findings. 
Sec. 202. Definitions. 
Sec. 203. Authority to assess and use device fees. 
Sec. 204. Reauthorization; reporting requirements. 
Sec. 205. Savings clause. 
Sec. 206. Effective date. 
Sec. 207. Sunset clause. 
Sec. 208. Streamlined hiring authority to support activities related to the process 
for the review of device applications. 
TITLE III—FEES RELATING TO GENERIC DRUGS 
Sec. 301. Short title. 
Sec. 302. Authority to assess and use human generic drug fees. 
Sec. 303. Reauthorization; reporting requirements. 
Sec. 304. Sunset dates. 
Sec. 305. Effective date. 
Sec. 306. Amendment with respect to misbranding. 
Sec. 307. Streamlined hiring authority to support activities related to human ge-
neric drugs. 
Sec. 308. Additional reporting requirements. 
TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS 
Sec. 401. Short title; finding. 
Sec. 402. Fees relating to biosimilar biological products. 
21 USC 301 note. 
Food and Drug 
Administration 
Safety and 
Innovation Act. 
July 9, 2012 
[S. 3187] 
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126 STAT. 994 
PUBLIC LAW 112–144—JULY 9, 2012 
Sec. 403. Reauthorization; reporting requirements. 
Sec. 404. Sunset dates. 
Sec. 405. Effective date. 
Sec. 406. Savings clause. 
Sec. 407. Conforming amendment. 
Sec. 408. Additional reporting requirements. 
TITLE V—PEDIATRIC DRUGS AND DEVICES 
Sec. 501. Permanence. 
Sec. 502. Written requests. 
Sec. 503. Communication with Pediatric Review Committee. 
Sec. 504. Access to data. 
Sec. 505. Ensuring the completion of pediatric studies. 
Sec. 506. Pediatric study plans. 
Sec. 507. Reauthorizations. 
Sec. 508. Report. 
Sec. 509. Technical amendments. 
Sec. 510. Pediatric rare diseases. 
Sec. 511. Staff of Office of Pediatric Therapeutics. 
TITLE VI—MEDICAL DEVICE REGULATORY IMPROVEMENTS 
Sec. 601. Investigational device exemptions. 
Sec. 602. Clarification of least burdensome standard. 
Sec. 603. Agency documentation and review of significant decisions. 
Sec. 604. Device modifications requiring premarket notification prior to marketing. 
Sec. 605. Program to improve the device recall system. 
Sec. 606. Clinical holds on investigational device exemptions. 
Sec. 607. Modification of de novo application process. 
Sec. 608. Reclassification procedures. 
Sec. 609. Harmonization of device premarket review, inspection, and labeling sym-
bols. 
Sec. 610. Participation in international fora. 
Sec. 611. Reauthorization of third-party review. 
Sec. 612. Reauthorization of third-party inspection. 
Sec. 613. Humanitarian device exemptions. 
Sec. 614. Unique device identifier. 
Sec. 615. Sentinel. 
Sec. 616. Postmarket surveillance. 
Sec. 617. Custom devices. 
Sec. 618. Health information technology. 
Sec. 619. Good guidance practices relating to devices. 
Sec. 620. Pediatric device consortia. 
TITLE VII—DRUG SUPPLY CHAIN 
Sec. 701. Registration of domestic drug establishments. 
Sec. 702. Registration of foreign establishments. 
Sec. 703. Identification of drug excipient information with product listing. 
Sec. 704. Electronic system for registration and listing. 
Sec. 705. Risk-based inspection frequency. 
Sec. 706. Records for inspection. 
Sec. 707. Prohibition against delaying, denying, limiting, or refusing inspection. 
Sec. 708. Destruction of adulterated, misbranded, or counterfeit drugs offered for 
import. 
Sec. 709. Administrative detention. 
Sec. 710. Exchange of information. 
Sec. 711. Enhancing the safety and quality of the drug supply. 
Sec. 712. Recognition of foreign government inspections. 
Sec. 713. Standards for admission of imported drugs. 
Sec. 714. Registration of commercial importers. 
Sec. 715. Notification. 
Sec. 716. Protection against intentional adulteration. 
Sec. 717. Penalties for counterfeiting drugs. 
Sec. 718. Extraterritorial jurisdiction. 
TITLE VIII—GENERATING ANTIBIOTIC INCENTIVES NOW 
Sec. 801. Extension of exclusivity period for drugs. 
Sec. 802. Priority review. 
Sec. 803. Fast track product. 
Sec. 804. Clinical trials. 
Sec. 805. Reassessment of qualified infectious disease product incentives in 5 years. 
Sec. 806. Guidance on pathogen-focused antibacterial drug development. 
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126 STAT. 995 
PUBLIC LAW 112–144—JULY 9, 2012 
TITLE IX—DRUG APPROVAL AND PATIENT ACCESS 
Sec. 901. Enhancement of accelerated patient access to new medical treatments. 
Sec. 902. Breakthrough therapies. 
Sec. 903. Consultation with external experts on rare diseases, targeted therapies, 
and genetic targeting of treatments. 
Sec. 904. Accessibility of information on prescription drug container labels by vis-
ually impaired and blind consumers. 
Sec. 905. Risk-benefit framework. 
Sec. 906. Grants and Contracts for the Development of Orphan Drugs. 
Sec. 907. Reporting of inclusion of demographic subgroups in clinical trials and 
data analysis in applications for drugs, biologics, and devices. 
Sec. 908. Rare pediatric disease priority review voucher incentive program. 
TITLE X—DRUG SHORTAGES 
Sec. 1001. Discontinuance or interruption in the production of life-saving drugs. 
Sec. 1002. Annual reporting on drug shortages. 
Sec. 1003. Coordination; task force and strategic plan. 
Sec. 1004. Drug shortage list. 
Sec. 1005. Quotas applicable to drugs in shortage. 
Sec. 1006. Attorney General report on drug shortages. 
Sec. 1007. Hospital repackaging of drugs in shortage. 
Sec. 1008. Study on drug shortages. 
TITLE XI—OTHER PROVISIONS 
Subtitle A—Reauthorizations 
Sec. 1101. Reauthorization of provision relating to exclusivity of certain drugs con-
taining single enantiomers. 
Sec. 1102. Reauthorization of the critical path public-private partnerships. 
Subtitle B—Medical Gas Product Regulation 
Sec. 1111. Regulation of medical gases. 
Sec. 1112. Changes to regulations. 
Sec. 1113. Rules of construction. 
Subtitle C—Miscellaneous Provisions 
Sec. 1121. Guidance document regarding product promotion using the Internet. 
Sec. 1122. Combating prescription drug abuse. 
Sec. 1123. Optimizing global clinical trials. 
Sec. 1124. Advancing regulatory science to promote public health innovation. 
Sec. 1125. Information technology. 
Sec. 1126. Nanotechnology. 
Sec. 1127. Online pharmacy report to Congress. 
Sec. 1128. Report on small businesses. 
Sec. 1129. Protections for the commissioned corps of the public health service act. 
Sec. 1130. Compliance date for rule relating to sunscreen drug products for over- 
the-counter human use. 
Sec. 1131. Strategic integrated management plan. 
Sec. 1132. Assessment and modification of REMS. 
Sec. 1133. Extension of period for first applicant to obtain tentative approval with-
out forfeiting 180-day-exclusivity period. 
Sec. 1134. Deadline for determination on certain petitions. 
Sec. 1135. Final agency action relating to petitions and civil actions. 
Sec. 1136. Electronic submission of applications. 
Sec. 1137. Patient participation in medical product discussions. 
Sec. 1138. Ensuring adequate information regarding pharmaceuticals for all popu-
lations, particularly underrepresented subpopulations, including racial 
subgroups. 
Sec. 1139. Scheduling of hydrocodone. 
Sec. 1140. Study on Drug Labeling by Electronic Means. 
Sec. 1141. Recommendations on interoperability standards. 
Sec. 1142. Conflicts of interest. 
Sec. 1143. Notification of FDA intent to regulate laboratory-developed tests. 
Subtitle D—Synthetic Drugs 
Sec. 1151. Short title. 
Sec. 1152. Addition of synthetic drugs to schedule I of the Controlled Substances 
Act. 
Sec. 1153. Temporary scheduling to avoid imminent hazards to public safety expan-
sion. 
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126 STAT. 996 
PUBLIC LAW 112–144—JULY 9, 2012 
(b) REFERENCES IN ACT.—Except as otherwise specified, amend-
ments made by this Act to a section or other provision of law 
are amendments to such section or other provision of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 
TITLE I—FEES RELATING TO DRUGS 
SEC. 101. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the ‘‘Prescription 
Drug User Fee Amendments of 2012’’. 
(b) FINDING.—The Congress finds that the fees authorized by 
the amendments made in this title will be dedicated toward expe-
diting the drug development process and the process for the review 
of human drug applications, including postmarket drug safety 
activities, as set forth in the goals identified for purposes of part 
2 of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act, in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Chairman 
of the Committee on Energy and Commerce of the House of Rep-
resentatives, as set forth in the Congressional Record. 
SEC. 102. DEFINITIONS. 
Section 735(7) (21 U.S.C. 379g) is amended by striking 
‘‘expenses incurred in connection with’’ and inserting ‘‘expenses 
in connection with’’. 
SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES. 
Section 736 (21 U.S.C. 379h) is amended— 
(1) in subsection (a)— 
(A) in the matter preceding paragraph (1), by striking 
‘‘fiscal year 2008’’ and inserting ‘‘fiscal year 2013’’; 
(B) in paragraph (1)(A)— 
(i) in clause (i), by striking ‘‘(c)(5)’’ and inserting 
‘‘(c)(4)’’; and 
(ii) in clause (ii), by striking ‘‘(c)(5)’’ and inserting 
‘‘(c)(4)’’; 
(C) in the matter following clause (ii) in paragraph 
(2)(A)— 
(i) by striking ‘‘(c)(5)’’ and inserting ‘‘(c)(4)’’; and 
(ii) by striking ‘‘payable on or before October 1 
of each year’’ and inserting ‘‘due on the later of the 
first business day on or after October 1 of each fiscal 
year or the first business day after the enactment 
of an appropriations Act providing for the collection 
and obligation of fees for such fiscal year under this 
section’’; 
(D) in paragraph (3)— 
(i) in subparagraph (A)— 
(I) by striking ‘‘subsection (c)(5)’’ and inserting 
‘‘subsection (c)(4)’’; and 
(II) by striking ‘‘payable on or before October 
1 of each year.’’ and inserting ‘‘due on the later 
of the first business day on or after October 1 
of each fiscal year or the first business day after 
the enactment of an appropriations Act providing 
21 USC 379g 
note. 
Prescription 
Drug User Fee 
Amendments 
of 2012. 
21 USC 301 note. 
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126 STAT. 997 
PUBLIC LAW 112–144—JULY 9, 2012 
for the collection and obligation of fees for such 
fiscal year under this section.’’; and 
(ii) by amending subparagraph (B) to read as fol-
lows: 
‘‘(B) EXCEPTION.—A prescription drug product shall not 
be assessed a fee under subparagraph (A) if such product 
is— 
‘‘(i) identified on the list compiled under section 
505(j)(7) with a potency described in terms of per 100 
mL; 
‘‘(ii) the same product as another product that— 
‘‘(I) was approved under an application filed 
under section 505(b) or 505(j); and 
‘‘(II) is not in the list of discontinued products 
compiled under section 505(j)(7); 
‘‘(iii) the same product as another product that 
was approved under an abbreviated application filed 
under section 507 (as in effect on the day before the 
date of enactment of the Food and Drug Administration 
Modernization Act of 1997); or 
‘‘(iv) the same product as another product that 
was approved under an abbreviated new drug applica-
tion pursuant to regulations in effect prior to the 
implementation of the Drug Price Competition and 
Patent Term Restoration Act of 1984.’’; 
(2) in subsection (b)— 
(A) in paragraph (1)— 
(i) in the matter preceding subparagraph (A), by 
striking ‘‘fiscal years 2008 through 2012’’ and inserting 
‘‘fiscal years 2013 through 2017’’; 
(ii) in subparagraph (A), by striking ‘‘$392,783,000; 
and’’ and inserting ‘‘$693,099,000;’’; and 
(iii) by striking subparagraph (B) and inserting 
the following: 
‘‘(B) the dollar amount equal to the inflation adjust-
ment for fiscal year 2013 (as determined under paragraph 
(3)(A)); and 
‘‘(C) the dollar amount equal to the workload adjust-
ment for fiscal year 2013 (as determined under paragraph 
(3)(B)).’’; and 
(B) by striking paragraphs (3) and (4) and inserting 
the following: 
‘‘(3) FISCAL YEAR 2013 INFLATION AND WORKLOAD ADJUST-
MENTS.—For purposes of paragraph (1), the dollar amount of 
the inflation and workload adjustments for fiscal year 2013 
shall be determined as follows: 
‘‘(A) INFLATION
ADJUSTMENT.—The inflation adjust-
ment for fiscal year 2013 shall be the sum of— 
‘‘(i) $652,709,000 multiplied by the result of an 
inflation adjustment calculation determined using the 
methodology described in subsection (c)(1)(B); and 
‘‘(ii) $652,709,000 multiplied by the result of an 
inflation adjustment calculation determined using the 
methodology described in subsection (c)(1)(C). 
‘‘(B) WORKLOAD
ADJUSTMENT.—Subject to subpara-
graph (C), the workload adjustment for fiscal 2013 shall 
be— 
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126 STAT. 998 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(i) $652,709,000 plus the amount of the inflation 
adjustment calculated under subparagraph (A); multi-
plied by 
‘‘(ii) the amount (if any) by which a percentage 
workload adjustment for fiscal year 2013, as deter-
mined using the methodology described in subsection 
(c)(2)(A), would exceed the percentage workload adjust-
ment (as so determined) for fiscal year 2012, if both 
such adjustment percentages were calculated using the 
5-year base period consisting of fiscal years 2003 
through 2007. 
‘‘(C) LIMITATION.—Under no circumstances shall the 
adjustment under subparagraph (B) result in fee revenues 
for fiscal year 2013 that are less than the sum of the 
amount under paragraph (1)(A) and the amount under 
paragraph (1)(B).’’; 
(3) by striking subsection (c) and inserting the following: 
‘‘(c) ADJUSTMENTS.— 
‘‘(1) INFLATION ADJUSTMENT.—For fiscal year 2014 and sub-
sequent fiscal years, the revenues established in subsection 
(b) shall be adjusted by the Secretary by notice, published 
in the Federal Register, for a fiscal year by the amount equal 
to the sum of— 
‘‘(A) one; 
‘‘(B) the average annual percent change in the cost, 
per full-time equivalent position of the Food and Drug 
Administration, of all personnel compensation and benefits 
paid with respect to such positions for the first 3 years 
of the preceding 4 fiscal years, multiplied by the proportion 
of personnel compensation and benefits costs to total costs 
of the process for the review of human drug applications 
(as defined in section 735(6)) for the first 3 years of the 
preceding 4 fiscal years, and 
‘‘(C) the average annual percent change that occurred 
in the Consumer Price Index for urban consumers (Wash-
ington-Baltimore, 
DC–MD–VA–WV; 
Not 
Seasonally 
Adjusted; All items; Annual Index) for the first 3 years 
of the preceding 4 years of available data multiplied by 
the proportion of all costs other than personnel compensa-
tion and benefits costs to total costs of the process for 
the review of human drug applications (as defined in sec-
tion 735(6)) for the first 3 years of the preceding 4 fiscal 
years. 
The adjustment made each fiscal year under this paragraph 
shall be added on a compounded basis to the sum of all adjust-
ments made each fiscal year after fiscal year 2013 under this 
paragraph. 
‘‘(2) WORKLOAD
ADJUSTMENT.—For fiscal year 2014 and 
subsequent fiscal years, after the fee revenues established in 
subsection (b) are adjusted for a fiscal year for inflation in 
accordance with paragraph (1), the fee revenues shall be 
adjusted further for such fiscal year to reflect changes in the 
workload of the Secretary for the process for the review of 
human drug applications. With respect to such adjustment: 
‘‘(A) The adjustment shall be determined by the Sec-
retary based on a weighted average of the change in the 
total number of human drug applications (adjusted for 
Determination. 
Time period. 
Notice. 
Federal Register, 
publication. 
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126 STAT. 999 
PUBLIC LAW 112–144—JULY 9, 2012 
changes in review activities, as described in the notice 
that the Secretary is required to publish in the Federal 
Register under this subparagraph), efficacy supplements, 
and manufacturing supplements submitted to the Sec-
retary, and the change in the total number of active 
commercial investigational new drug applications (adjusted 
for changes in review activities, as so described) during 
the most recent 12-month period for which data on such 
submissions is available. The Secretary shall publish in 
the Federal Register the fee revenues and fees resulting 
from the adjustment and the supporting methodologies. 
‘‘(B) Under no circumstances shall the adjustment 
result in fee revenues for a fiscal year that are less than 
the sum of the amount under subsection (b)(1)(A) and the 
amount under subsection (b)(1)(B), as adjusted for inflation 
under paragraph (1). 
‘‘(C) The Secretary shall contract with an independent 
accounting or consulting firm to periodically review the 
adequacy of the adjustment and publish the results of 
those reviews. The first review shall be conducted and 
published by the end of fiscal year 2013 (to examine the 
performance of the adjustment since fiscal year 2009), and 
the second review shall be conducted and published by 
the end of fiscal year 2015 (to examine the continued 
performance of the adjustment). The reports shall evaluate 
whether the adjustment reasonably represents actual 
changes in workload volume and complexity and present 
options to discontinue, retain, or modify any elements of 
the adjustment. The reports shall be published for public 
comment. After review of the reports and receipt of public 
comments, the Secretary shall, if warranted, adopt appro-
priate changes to the methodology. If the Secretary adopts 
changes to the methodology based on the first report, the 
changes shall be effective for the first fiscal year for which 
fees are set after the Secretary adopts such changes and 
each subsequent fiscal year. 
‘‘(3) FINAL YEAR ADJUSTMENT.—For fiscal year 2017, the 
Secretary may, in addition to adjustments under this paragraph 
and paragraphs (1) and (2), further increase the fee revenues 
and fees established in subsection (b) if such an adjustment 
is necessary to provide for not more than 3 months of operating 
reserves of carryover user fees for the process for the review 
of human drug applications for the first 3 months of fiscal 
year 2018. If such an adjustment is necessary, the rationale 
for the amount of the increase shall be contained in the annual 
notice establishing fee revenues and fees for fiscal year 2017. 
If the Secretary has carryover balances for such process in 
excess of 3 months of such operating reserves, the adjustment 
under this paragraph shall not be made. 
‘‘(4) ANNUAL FEE SETTING.—The Secretary shall, not later 
than 60 days before the start of each fiscal year that begins 
after September 30, 2012, establish, for the next fiscal year, 
application, product, and establishment fees under subsection 
(a), based on the revenue amounts established under subsection 
(b) and the adjustments provided under this subsection. 
‘‘(5) LIMIT.—The total amount of fees charged, as adjusted 
under this subsection, for a fiscal year may not exceed the 
Deadline. 
Effective date. 
Publication. 
Public comments. 
Reports. 
Contracts. 
Reviews. 
Deadlines. 
Federal Register, 
publication. 
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126 STAT. 1000 
PUBLIC LAW 112–144—JULY 9, 2012 
total costs for such fiscal year for the resources allocated for 
the process for the review of human drug applications.’’; and 
(4) in subsection (g)— 
(A) in paragraph (1), by striking ‘‘Fees authorized’’ 
and inserting ‘‘Subject to paragraph (2)(C), fees authorized’’; 
(B) in paragraph (2)— 
(i) in subparagraph (A)(i), by striking ‘‘shall be 
retained’’ and inserting ‘‘subject to subparagraph (C), 
shall be collected and available’’; 
(ii) in subparagraph (A)(ii), by striking ‘‘shall only 
be collected and available’’ and inserting ‘‘shall be 
available’’; and 
(iii) by adding at the end the following new 
subparagraph: 
‘‘(C) PROVISION FOR EARLY PAYMENTS.—Payment of fees 
authorized under this section for a fiscal year, prior to 
the due date for such fees, may be accepted by the Secretary 
in accordance with authority provided in advance in a 
prior year appropriations Act.’’; 
(C) in paragraph (3), by striking ‘‘fiscal years 2008 
through 2012’’ and inserting ‘‘fiscal years 2013 through 
2017’’; and 
(D) in paragraph (4)— 
(i) by striking ‘‘fiscal years 2008 through 2010’’ 
and inserting ‘‘fiscal years 2013 through 2015’’; 
(ii) by striking ‘‘fiscal year 2011’’ and inserting 
‘‘fiscal year 2016’’; 
(iii) by striking ‘‘fiscal years 2008 through 2011’’ 
and inserting ‘‘fiscal years 2013 through 2016’’; and 
(iv) by striking ‘‘fiscal year 2012’’ and inserting 
‘‘fiscal year 2017’’. 
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 736B (21 U.S.C. 379h–2) is amended— 
(1) by amending subsection (a) to read as follows: 
‘‘(a) PERFORMANCE REPORT.— 
‘‘(1) IN
GENERAL.—Beginning with fiscal year 2013, not 
later than 120 days after the end of each fiscal year for which 
fees are collected under this part, the Secretary shall prepare 
and submit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report con-
cerning— 
‘‘(A) the progress of the Food and Drug Administration 
in achieving the goals identified in the letters described 
in section 101(b) of the Prescription Drug User Fee Amend-
ments of 2012 during such fiscal year and the future plans 
of the Food and Drug Administration for meeting the goals, 
including the status of the independent assessment 
described in such letters; and 
‘‘(B) the progress of the Center for Drug Evaluation 
and Research and the Center for Biologics Evaluation and 
Research in achieving the goals, and future plans for 
meeting the goals, including, for each review division— 
‘‘(i) the number of original standard new drug 
applications and biologics license applications filed per 
fiscal year for each review division; 
Effective date. 
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126 STAT. 1001 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(ii) the number of original priority new drug 
applications and biologics license applications filed per 
fiscal year for each review division; 
‘‘(iii) the number of standard efficacy supplements 
filed per fiscal year for each review division; 
‘‘(iv) the number of priority efficacy supplements 
filed per fiscal year for each review division; 
‘‘(v) the number of applications filed for review 
under accelerated approval per fiscal year for each 
review division; 
‘‘(vi) the number of applications filed for review 
as fast track products per fiscal year for each review 
division; 
‘‘(vii) the number of applications filed for orphan- 
designated products per fiscal year for each review 
division; and 
‘‘(viii) the number of breakthrough designations 
for a fiscal year for each review division. 
‘‘(2) INCLUSION.—The report under this subsection for a 
fiscal year shall include information on all previous cohorts 
for which the Secretary has not given a complete response 
on all human drug applications and supplements in the cohort.’’. 
(2) in subsection (b), by striking ‘‘2008’’ and inserting 
‘‘2013’’; and 
(3) in subsection (d), by striking ‘‘2012’’ each place it 
appears and inserting ‘‘2017’’. 
SEC. 105. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 735 and 736 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to 
be effective October 1, 2017. 
(b) REPORTING REQUIREMENTS.—Section 736B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) shall cease to 
be effective January 31, 2018. 
(c) PREVIOUS SUNSET PROVISION.— 
(1) IN
GENERAL.—Section 106 of the Food and Drug 
Administration Amendments Act of 2007 (Public Law 110– 
85) is repealed. 
(2) CONFORMING
AMENDMENT.—The Food and Drug 
Administration Amendments Act of 2007 (Public Law 110– 
85) is amended in the table of contents in section 2, by striking 
the item relating to section 106. 
(d) TECHNICAL CLARIFICATIONS.— 
(1) Effective September 30, 2007— 
(A) section 509 of the Prescription Drug User Fee 
Amendments Act of 2002 (Title V of Public Law 107– 
188) is repealed; and 
(B) the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (Public Law 107– 
188) is amended in the table of contents in section 1(b), 
by striking the item relating to section 509. 
(2) Effective September 30, 2002— 
(A) section 107 of the Food and Drug Administration 
Modernization Act of 1997 (Public Law 105–115) is 
repealed; and 
(B) the table of contents in section 1(c) of such Act 
is amended by striking the item related to section 107. 
21 USC 379g 
notes. 
21 USC 379g 
note. 
Repeals. 
21 USC 379g 
note, 379h–2 
note. 
21 USC 379g–2 
note. 
21 USC 379g 
note. 
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126 STAT. 1002 
PUBLIC LAW 112–144—JULY 9, 2012 
(3) Effective September 30, 1997, section 105 of the 
Prescription Drug User Fee Act of 1992 (Public Law 102– 
571) is repealed. 
SEC. 106. EFFECTIVE DATE. 
The amendments made by this title shall take effect on October 
1, 2012, or the date of the enactment of this Act, whichever is 
later, except that fees under part 2 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 
for all human drug applications received on or after October 1, 
2012, regardless of the date of the enactment of this Act. 
SEC. 107. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, part 2 
of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act, as in effect on the day before the date of the enact-
ment of this title, shall continue to be in effect with respect to 
human drug applications and supplements (as defined in such part 
as of such day) that on or after October 1, 2007, but before October 
1, 2012, were accepted by the Food and Drug Administration for 
filing with respect to assessing and collecting any fee required 
by such part for a fiscal year prior to fiscal year 2012. 
TITLE II—FEES RELATING TO DEVICES 
SEC. 201. SHORT TITLE; FINDINGS. 
(a) SHORT TITLE.—This title may be cited as the ‘‘Medical 
Device User Fee Amendments of 2012’’. 
(b) FINDINGS.—The Congress finds that the fees authorized 
under the amendments made by this title will be dedicated toward 
expediting the process for the review of device applications and 
for assuring the safety and effectiveness of devices, as set forth 
in the goals identified for purposes of part 3 of subchapter C 
of chapter VII of the Federal Food, Drug, and Cosmetic Act in 
the letters from the Secretary of Health and Human Services to 
the Chairman of the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Chairman of the Committee on 
Energy and Commerce of the House of Representatives, as set 
forth in the Congressional Record. 
SEC. 202. DEFINITIONS. 
Section 737 (21 U.S.C. 379i) is amended— 
(1) in paragraph (9), by striking ‘‘incurred’’ after ‘‘expenses’’; 
(2) in paragraph (10), by striking ‘‘October 2001’’ and 
inserting ‘‘October 2011’’; and 
(3) in paragraph (13), by striking ‘‘is required to register’’ 
and all that follows through the end of paragraph (13) and 
inserting the following: ‘‘is registered (or is required to register) 
with the Secretary under section 510 because such establish-
ment is engaged in the manufacture, preparation, propagation, 
compounding, or processing of a device.’’. 
SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES. 
(a) TYPES
OF FEES.—Section 738(a) (21 U.S.C. 379j(a)) is 
amended— 
(1) in paragraph (1), by striking ‘‘fiscal year 2008’’ and 
inserting ‘‘fiscal year 2013’’; 
21 USC 379i 
note. 
21 USC 301 note. 
Medical Device 
User Fee 
Amendments of 
2012. 
Continuation. 
Time period. 
21 USC 379g 
note. 
21 USC 379g 
note. 
21 USC 379g 
notes. 
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126 STAT. 1003 
PUBLIC LAW 112–144—JULY 9, 2012 
(2) in paragraph (2)(A)— 
(A) in the matter preceding clause (i)— 
(i) by striking ‘‘subsections (d) and (e)’’ and 
inserting ‘‘subsections (d), (e), and (f)’’; 
(ii) by striking ‘‘October 1, 2002’’ and inserting 
‘‘October 1, 2012’’; and 
(iii) by striking ‘‘subsection (c)(1)’’ and inserting 
‘‘subsection (c)’’; and 
(B) in clause (viii), by striking ‘‘1.84’’ and inserting 
‘‘2’’; and 
(3) in paragraph (3)— 
(A) in subparagraph (A), by inserting ‘‘and subsection 
(f)’’ after ‘‘subparagraph (B)’’; and 
(B) in subparagraph (C), by striking ‘‘initial registra-
tion’’ and all that follows through ‘‘section 510.’’ and 
inserting ‘‘later of— 
‘‘(i) the initial or annual registration (as applicable) 
of the establishment under section 510; or 
‘‘(ii) the first business day after the date of enact-
ment of an appropriations Act providing for the collec-
tion and obligation of fees for such year under this 
section.’’. 
(b) FEE
AMOUNTS.—Section 738(b) (21 U.S.C. 379j(b)) is 
amended to read as follows: 
‘‘(b) FEE AMOUNTS.— 
‘‘(1) IN GENERAL.—Subject to subsections (c), (d), (e), (f), 
and (i), for each of fiscal years 2013 through 2017, fees under 
subsection (a) shall be derived from the base fee amounts 
specified in paragraph (2), to generate the total revenue 
amounts specified in paragraph (3). 
‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For purposes of para-
graph (1), the base fee amounts specified in this paragraph 
are as follows: 
‘‘Fee Type 
Fiscal 
Year 
2013 
Fiscal 
Year 
2014 
Fiscal 
Year 
2015 
Fiscal 
Year 
2016 
Fiscal 
Year 
2017 
Premarket Application ....
$248,000 
$252,960 
$258,019 
$263,180 
$268,443 
Establishment Registra-
tion ................................
$2,575 
$3,200 
$3,750 
$3,872 
$3,872 
‘‘(3) TOTAL
REVENUE
AMOUNTS
SPECIFIED.—For purposes 
of paragraph (1), the total revenue amounts specified in this 
paragraph are as follows: 
‘‘(A) $97,722,301 for fiscal year 2013. 
‘‘(B) $112,580,497 for fiscal year 2014. 
‘‘(C) $125,767,107 for fiscal year 2015. 
‘‘(D) $129,339,949 for fiscal year 2016. 
‘‘(E) $130,184,348 for fiscal year 2017.’’. 
(c) ANNUAL FEE SETTING; ADJUSTMENTS.—Section 738(c) (21 
U.S.C. 379j(c)) is amended— 
(1) in the subsection heading, by inserting ‘‘; ADJUSTMENTS’’ 
after ‘‘SETTING’’; 
(2) by striking paragraphs (1) and (2); 
(3) by redesignating paragraphs (3) and (4) as paragraphs 
(4) and (5), respectively; and 
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126 STAT. 1004 
PUBLIC LAW 112–144—JULY 9, 2012 
(4) by inserting before paragraph (4), as so redesignated, 
the following: 
‘‘(1) IN GENERAL.—The Secretary shall, 60 days before the 
start of each fiscal year after September 30, 2012, establish 
fees under subsection (a), based on amounts specified under 
subsection (b) and the adjustments provided under this sub-
section, and publish such fees, and the rationale for any adjust-
ments to such fees, in the Federal Register. 
‘‘(2) INFLATION ADJUSTMENTS.— 
‘‘(A) ADJUSTMENT TO TOTAL REVENUE AMOUNTS.—For 
fiscal year 2014 and each subsequent fiscal year, the Sec-
retary shall adjust the total revenue amount specified in 
subsection (b)(3) for such fiscal year by multiplying such 
amount by the applicable inflation adjustment under 
subparagraph (B) for such year. 
‘‘(B) APPLICABLE INFLATION ADJUSTMENT TO TOTAL REV-
ENUE AMOUNTS.—The applicable inflation adjustment for 
a fiscal year is— 
‘‘(i) for fiscal year 2014, the base inflation adjust-
ment under subparagraph (C) for such fiscal year; and 
‘‘(ii) for fiscal year 2015 and each subsequent fiscal 
year, the product of— 
‘‘(I) the base inflation adjustment under 
subparagraph (C) for such fiscal year; and 
‘‘(II) the product of the base inflation adjust-
ment under subparagraph (C) for each of the fiscal 
years preceding such fiscal year, beginning with 
fiscal year 2014. 
‘‘(C) BASE INFLATION ADJUSTMENT TO TOTAL REVENUE 
AMOUNTS.— 
‘‘(i) IN GENERAL.—Subject to further adjustment 
under clause (ii), the base inflation adjustment for 
a fiscal year is the sum of one plus— 
‘‘(I) the average annual percent change in the 
cost, per full-time equivalent position of the Food 
and Drug Administration, of all personnel com-
pensation and benefits paid with respect to such 
positions for the first 3 years of the preceding 
4 fiscal years, multiplied by 0.60; and 
‘‘(II) the average annual percent change that 
occurred in the Consumer Price Index for urban 
consumers (Washington-Baltimore, DC–MD–VA– 
WV; Not 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 
Time period. 
Federal Register, 
publication. 
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126 STAT. 1005 
PUBLIC LAW 112–144—JULY 9, 2012 
revenue amounts under subsection (b)(3), as adjusted for 
inflation under subparagraph (A). 
‘‘(3) VOLUME-BASED ADJUSTMENTS TO ESTABLISHMENT REG-
ISTRATION 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 sub-
section: 
‘‘(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 sub-
section (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 appro-
priated 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 
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126 STAT. 1006 
PUBLIC LAW 112–144—JULY 9, 2012 
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 aggre-
gate 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 let-
ters 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, 
Public 
information. 
Web site. 
Deadlines. 
Effective date. 
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126 STAT. 1007 
PUBLIC LAW 112–144—JULY 9, 2012 
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 Mod-
ernization 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 authori-
ties under other provisions of law, the Secretary may, without 
regard to the provisions of title 5, United States Code, governing 
21 USC 379d–3. 
21 USC 379i 
notes. 
Repeal. 
121 Stat. 823. 
21 USC 379i 
note. 
Repeal. 
21 USC 379i 
note. 
21 USC 379i 
note. 
Continuation. 
Time period. 
21 USC 379i 
note. 
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126 STAT. 1008 
PUBLIC LAW 112–144—JULY 9, 2012 
appointments in the competitive service, appoint employees to posi-
tions 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 objec-
tives 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 appro-
priate 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 pur-
poses 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 implementa-
tion of the Drug Price Competition and Patent Term Res-
toration 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— 
21 USC 379j–41. 
21 USC 379j–41 
note. 
21 USC 301 note. 
Generic Drug 
User Fee 
Amendments of 
2012. 
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126 STAT. 1009 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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, treat-
ment, 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 pharma-
ceutical 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 manage-
ment; 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 con-
stitute multiple facilities, one per management entity, for pur-
poses 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, solu-
tion, 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 ingre-
dient with another component of a drug product for pur-
poses of production of a drug product described in subpara-
graph (A) or (B). 
‘‘(7) The term ‘generic drug submission’ means an abbre-
viated new drug application, an amendment to an abbreviated 
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126 STAT. 1010 
PUBLIC LAW 112–144—JULY 9, 2012 
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 applica-
tions; 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 tech-
nology 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 
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126 STAT. 1011 
PUBLIC LAW 112–144—JULY 9, 2012 
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 Adminis-
tration, advisory committees, and costs related to such 
officers and employees and to contracts with such contrac-
tors; 
‘‘(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 fix-
tures, 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 submis-
sion applicant. 
‘‘SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 
FEES. 
‘‘(a) TYPES OF FEES.—Beginning in fiscal year 2013, the Sec-
retary 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 abbre-
viated 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 subpara-
graph (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 
Deadline. 
Federal Register, 
publication. 
Effective date. 
21 USC 379j–42. 
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126 STAT. 1012 
PUBLIC LAW 112–144—JULY 9, 2012 
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 ingre-
dient 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 Reg-
ister 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 pharma-
ceutical 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 subpara-
graph (C), as applicable; or 
‘‘(II) 30 calendar days after the date of enact-
ment of an appropriations Act providing for the 
collection and obligation of fees under this section. 
Public 
information. 
Web site. 
Criteria. 
Publication. 
Deadline. 
Criteria. 
Publication. 
Deadlines. 
Federal Register, 
publication. 
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126 STAT. 1013 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 applica-
tion 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 sub-
section (d). 
‘‘(B) NOTICE.— 
‘‘(i) FISCAL YEAR 2013.—Not later than October 31, 
2012, the Secretary shall publish in the Federal Reg-
ister 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 subpara-
graph (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
CON-
SIDERS 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 
Deadlines. 
Federal Register, 
publications. 
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126 STAT. 1014 
PUBLIC LAW 112–144—JULY 9, 2012 
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 con-
cerning 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 pharma-
ceutical drug master file; and 
‘‘(ii) a fee in the amount equal to the drug master 
file fee established in paragraph (2) has not been pre-
viously paid with respect to such information. 
‘‘(4) GENERIC
DRUG
FACILITY
FEE
AND
ACTIVE
PHARMA-
CEUTICAL 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 ingre-
dient 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 pro-
duces, 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 PHARMA-
CEUTICAL 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 
Federal Register, 
publications. 
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126 STAT. 1015 
PUBLIC LAW 112–144—JULY 9, 2012 
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 Adminis-
tration— 
‘‘(A) if it is submitted via a Food and Drug Administra-
tion 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, Fed-
eral holiday, or day when the Food and Drug Administra-
tion 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 esti-
mated 
revenue 
amount 
under 
such 
subsection 
of 
$299,000,000. Of that amount— 
‘‘(i) $50,000,000 shall be generated by the one- 
time backlog fee for generic drug applications pending 
on October 1, 2012, established in subsection (a)(1); 
and 
‘‘(ii) $249,000,000 shall be generated by the fees 
under paragraphs (2) through (4) of subsection (a). 
‘‘(B) FISCAL YEARS 2014 THROUGH 2017.—For each of 
the fiscal years 2014 through 2017, fees under paragraphs 
(2) through (4) of subsection (a) shall be established to 
generate a total estimated revenue amount under such 
subsection that is equal to $299,000,000, as adjusted pursu-
ant to subsection (c). 
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126 STAT. 1016 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 sub-
section (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 deter-
mined 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 sub-
sequent fiscal years, the revenues established in subsection 
(b) shall be adjusted by the Secretary by notice, published 
in the Federal Register, for a fiscal year, by 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 (Wash-
ington-Baltimore, 
DC–MD–VA–WV; 
Not 
Seasonally 
Adjusted; All items; Annual Index) for the first 3 years 
of the preceding 4 years of available data multiplied by 
Notice. 
Federal Register, 
publication. 
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126 STAT. 1017 
PUBLIC LAW 112–144—JULY 9, 2012 
the proportion of all costs other than personnel compensa-
tion 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 adjust-
ments 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 sub-
section (c). 
‘‘(3) 
FEE
FOR
ACTIVE
PHARMACEUTICAL
INGREDIENT 
INFORMATION NOT INCLUDED BY REFERENCE TO TYPE II ACTIVE 
PHARMACEUTICAL
INGREDIENT
DRUG
MASTER
FILE.—In estab-
lishing 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 
Time period. 
Deadlines. 
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126 STAT. 1018 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 pharma-
ceutical 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 emis-
sion 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 owner-
ship, 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 con-
ducted; 
‘‘(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 
Federal Register, 
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Deadlines. 
Federal Register, 
publication. 
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126 STAT. 1019 
PUBLIC LAW 112–144—JULY 9, 2012 
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 inspec-
tion 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 sub-
section (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 sec-
tion 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 ref-
erences 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 abbre-
viated 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 
Notification. 
Public 
information. 
Deadlines. 
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126 STAT. 1020 
PUBLIC LAW 112–144—JULY 9, 2012 
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 sub-
section (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 abbre-
viated 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 ingre-
dient 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 applica-
tion or supplement to an abbreviated new drug applica-
tion 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. 
Effective date. 
Public 
information. 
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126 STAT. 1021 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 pharma-
ceutical 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 sub-
section (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 limita-
tion 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 sec-
tion— 
‘‘(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 appro-
priation Acts, or otherwise made available for obliga-
tion 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 allo-
cates for such purpose an amount for such fiscal year 
(excluding amounts from fees collected under this sec-
tion) no less than $97,000,000 multiplied by the adjust-
ment 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 appropria-
tions 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 
Effective date. 
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126 STAT. 1022 
PUBLIC LAW 112–144—JULY 9, 2012 
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 appro-
priated 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 Sec-
retary 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 activi-
ties, 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 pharma-
ceutical 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 
Effective date. 
21 USC 379j–43. 
Deadline. 
Deadline. 
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126 STAT. 1023 
PUBLIC LAW 112–144—JULY 9, 2012 
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 Rep-
resentatives 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 Administra-
tion. 
‘‘(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 sub-
section (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 representa-
tives 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 para-
graph (2). 
Web posting. 
Time period. 
Notice. 
Federal Register, 
publication. 
Web posting. 
Effective date. 
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126 STAT. 1024 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotia-
tions 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 Reg-
ister; 
‘‘(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 com-
ments, 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 rec-
ommendations developed under paragraphs (1) through (5) 
to the Congress, the Secretary shall make publicly avail-
able, on the Internet Web site of the Food and Drug 
Administration, minutes of all negotiation meetings con-
ducted under this subsection between the Food and Drug 
Administration and the generic drug industry. 
‘‘(B) CONTENT.—The minutes described under subpara-
graph (A) shall summarize any substantive proposal made 
by any party to the negotiations as well as significant 
controversies or differences of opinion during the negotia-
tions 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 pharma-
ceutical 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 
21 USC 379j–41 
note. 
21 USC 379j–43 
note. 
21 USC 379j–41 
note. 
Web posting. 
Time period. 
Federal Register, 
publication. 
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126 STAT. 1025 
PUBLIC LAW 112–144—JULY 9, 2012 
pharmaceutical ingredient that was manufactured, prepared, propa-
gated, 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 fol-
lowing: 
‘‘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 applica-
tions, and prior approval supplements with respect to such applica-
tions 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 Chair-
man of the Committee on Health, Education, Labor, and Pen-
sions 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 pre-
vious 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 supple-
ments with respect to such applications that were pending 
with the Secretary for more than 10 months on the date of 
Effective date. 
21 USC 379d–4. 
21 USC 379d–3. 
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126 STAT. 1026 
PUBLIC LAW 112–144—JULY 9, 2012 
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 applica-
tions, 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 licen-
sure 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; 
21 USC 379j–51. 
21 USC 379j–51 
note. 
21 USC 301 note. 
Biosimilar User 
Fee Act of 2012. 
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126 STAT. 1027 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 paren-
teral 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 trans-
fusion; 
‘‘(II) an allergenic extract product; 
‘‘(III) an in vitro diagnostic biological product; or 
‘‘(IV) a biological product for further manufac-
turing 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 pro-
gram, 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 establish-
ment’ 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 ‘manu-
factured’ 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 licen-
sure 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 sub-
stantive 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 Adminis-
tration, 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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126 STAT. 1028 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(C) leasing, maintenance, renovation, and repair of 
facilities and acquisition, maintenance, and repair of fix-
tures, 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 investiga-
tion 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 submis-
sions 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 defi-
ciencies 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 bio-
similar 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 applica-
tions. 
‘‘(F) Postmarket safety activities with respect to bio-
logics approved under biosimilar biological product applica-
tions or supplements, including the following activities: 
‘‘(i) Collecting, developing, and reviewing safety 
information on biosimilar biological products, including 
adverse-event reports. 
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126 STAT. 1029 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(ii) Developing and using improved adverse-event 
data-collection systems, including information tech-
nology 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 Sec-
retary 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 Sec-
retary shall assess and collect fees in accordance with this section 
as follows: 
‘‘(1) BIOSIMILAR DEVELOPMENT PROGRAM FEES.— 
‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOP-
MENT 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 bio-
similar 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 pro-
tocol for an investigational new drug protocol described 
in this clause is a clinical protocol consistent with 
the provisions of section 505(i), including any regula-
tions promulgated under section 505(i), (referred to 
in this section as ‘investigational new drug application’) 
describing an investigation that the Secretary deter-
mines 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 investiga-
tional new drug application describing an inves-
tigation that the Secretary determines is intended 
Effective date. 
21 USC 379j–52. 
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126 STAT. 1030 
PUBLIC LAW 112–144—JULY 9, 2012 
to support a biosimilar biological product applica-
tion. 
‘‘(v) TRANSITION RULE.—Each person that has sub-
mitted 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 inves-
tigational new drug application describes an inves-
tigation 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 develop-
ment 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 bio-
similar 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 con-
cerning 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 con-
cerning the product has been submitted, withdrawing 
Deadline. 
Deadlines. 
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126 STAT. 1031 
PUBLIC LAW 112–144—JULY 9, 2012 
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 subpara-
graph (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 discon-
tinued). 
‘‘(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 DEVELOP-
MENT PROGRAM FEES.— 
‘‘(i) NO BIOSIMILAR BIOLOGICAL PRODUCT DEVELOP-
MENT
MEETINGS.—If a person has failed to pay an 
initial or annual biosimilar biological product develop-
ment 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 inves-
tigation is intended to support a biosimilar 
biological product application; and 
‘‘(II) the sponsor has failed to pay an initial 
or annual biosimilar biological product develop-
ment 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 inves-
tigation from continuing the investigation if— 
‘‘(I) the Secretary determines that the inves-
tigation is intended to support a biosimilar 
biological product application; and 
Deadline. 
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126 STAT. 1032 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(II) the sponsor has failed to pay an initial 
or annual biosimilar biological product develop-
ment 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 PRO-
GRAM 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 applica-
tion 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 para-
graph (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 compara-
tive 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 para-
graph (1) for that product. 
‘‘(iii) A fee for a supplement for which clinical 
data (other than comparative bioavailability studies) 
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126 STAT. 1033 
PUBLIC LAW 112–144—JULY 9, 2012 
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 para-
graph (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 applica-
tion 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 suc-
cessor) 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 sub-
mitted 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 sub-
section (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 bio-
similar 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 
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126 STAT. 1034 
PUBLIC LAW 112–144—JULY 9, 2012 
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 establish-
ment 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, 
Time period. 
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126 STAT. 1035 
PUBLIC LAW 112–144—JULY 9, 2012 
the fees under subsection (a). Except as provided in subsection 
(c), such fees shall be in the following amounts: 
‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOP-
MENT
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 bio-
similar 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 applica-
tions. 
‘‘(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 affil-
iate 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 bio-
similar biological product applications submitted to the 
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126 STAT. 1036 
PUBLIC LAW 112–144—JULY 9, 2012 
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 intro-
duced 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 obliga-
tion 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 limita-
tion 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 other-
wise made available for obligation for such fiscal year. 
‘‘(B) USE OF FEES AND LIMITATION.—The fees author-
ized 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 appropria-
tions 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 
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PUBLIC LAW 112–144—JULY 9, 2012 
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 Sec-
retary 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 fol-
lowing: 
‘‘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 Rep-
resentatives 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 
Web posting. 
Effective date. 
21 USC 379j–53. 
Deadline. 
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126 STAT. 1038 
PUBLIC LAW 112–144—JULY 9, 2012 
public on the Internet Web site of the Food and Drug Administra-
tion. 
‘‘(d) STUDY.— 
‘‘(1) IN GENERAL.—The Secretary shall contract with an 
independent accounting or consulting firm to study the work-
load 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 applica-
tions 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 negotia-
tions 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 Reg-
ister; 
‘‘(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 com-
ments, 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. 
21 USC 379j–53 
note. 
21 USC 379j–51 
note. 
Time period. 
Federal Register, 
publication. 
Contracts. 
Publications. 
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126 STAT. 1039 
PUBLIC LAW 112–144—JULY 9, 2012 
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 enact-
ment of this title, shall continue to be in effect with respect to 
human drug applications and supplements (as defined in such part 
as of such day) that were accepted by the Food and Drug Adminis-
tration 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, Edu-
cation, 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). 
Effective date. 
21 USC 379d–4. 
Continuation. 
Time period. 
21 USC 379g 
note. 
21 USC 379j–51 
note. 
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126 STAT. 1040 
PUBLIC LAW 112–144—JULY 9, 2012 
(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 comple-
tion 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 com-
mittee 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 sen-
tence 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— 
Deadline. 
Public 
information. 
Web posting. 
Time period. 
21 USC 355a 
note. 
Public 
information. 
Web posting. 
Deadline. 
Procedures. 
21 USC 355a 
note. 
21 USC 355a. 
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126 STAT. 1041 
PUBLIC LAW 112–144—JULY 9, 2012 
(1) in subsection (a)(3)— 
(A) by redesignating subparagraph (B) as subpara-
graph (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 assess-
ments required under paragraph (1) if— 
‘‘(I) the Secretary determines that the condi-
tions described in subclause (II) or (III) of subpara-
graph (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 
Web posting. 
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126 STAT. 1042 
PUBLIC LAW 112–144—JULY 9, 2012 
Internet Web site of the Food and Drug Administra-
tion— 
‘‘(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 ‘‘defer-
rals’’. 
(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 sub-
section (a) or (b), in accordance with applicable provisions of sub-
sections (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 require-
ments 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 
Public 
information. 
Web posting. 
Notification. 
Effective date. 
Deadlines. 
Applicability. 
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126 STAT. 1043 
PUBLIC LAW 112–144—JULY 9, 2012 
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 sub-
section (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 let-
ters issued pursuant to subsection (d), and the recipi-
ents 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 Regula-
tions, 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 subpara-
graph. 
‘‘(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— 
Deadlines. 
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126 STAT. 1044 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 commu-
nicate 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 prac-
ticable, 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 agree-
ment 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 con-
firmation under paragraph (3) shall include a recommendation 
from the Secretary as to whether such request meets the stand-
ards 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 para-
graph (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 pro-
posed regulations and issue guidance to implement the provi-
sions 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,’’; 
Consultation. 
Applicability. 
Notification. 
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126 STAT. 1045 
PUBLIC LAW 112–144—JULY 9, 2012 
(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 ‘‘ini-
tial 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 respon-
sibilities 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 Pharma-
ceuticals 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 Sec-
retary shall prepare and submit to the Committee on Health, Edu-
cation, 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 
Public 
information. 
Web posting. 
21 USC 355c–1. 
21 USC 355c 
note. 
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126 STAT. 1046 
PUBLIC LAW 112–144—JULY 9, 2012 
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 pro-
grams that would lead to new and better therapies for children 
with cancer, including a detailed rationale for each rec-
ommendation; 
(9) any recommendations for modification to such programs 
that would improve pediatric drug research and increase pedi-
atric 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 
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126 STAT. 1047 
PUBLIC LAW 112–144—JULY 9, 2012 
(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 Sec-
retary, 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 pedi-
atric 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 modi-
fications 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 sub-
section shall prohibit the Office of Pediatric Therapeutics from 
providing for the review of adverse event reports by the Pedi-
atric 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)— 
Time period. 
Consultation. 
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PUBLIC LAW 112–144—JULY 9, 2012 
(I) in the first sentence, by inserting ‘‘, or 
for which a period of exclusivity eligible for exten-
sion 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 contra-
indications, 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 subpara-
graph (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 submis-
sion 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)— 
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PUBLIC LAW 112–144—JULY 9, 2012 
(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 sub-
section shall prohibit the Office of Pediatric Therapeutics from 
providing for the review of adverse event reports by the Pedi-
atric 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 EXTEN-
SIONS,’’ 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 Chil-
dren Act (Public Law 107–109), as amended by section 502(e) of 
the Food and Drug Administration Amendments Act of 2007 (Public 
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126 STAT. 1050 
PUBLIC LAW 112–144—JULY 9, 2012 
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 Sec-
retary 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 accel-
erating 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 individ-
uals 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 assess-
ment 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 
Time period. 
Effective date. 
Strategic plan. 
Deadline. 
Time period. 
Effective date. 
21 USC 355a 
note. 
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126 STAT. 1051 
PUBLIC LAW 112–144—JULY 9, 2012 
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 effective-
ness’’ 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 Sec-
retary determines that— 
‘‘(i) the investigation may not support a substantial equiva-
lence 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 clear-
ance of a device; or 
‘‘(iii) an additional or different investigation may be nec-
essary 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 determina-
tion by the Secretary that an application provides reasonable assur-
ance 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) When-
ever’’; 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 determina-
tion 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.— 
Definition. 
Definition. 
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PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(1) IN
GENERAL.—The Secretary shall provide a sub-
stantive summary of the scientific and regulatory rationale 
for any significant decision of the Center for Devices and Radio-
logical Health regarding submission or review of a report under 
section 510(k), an application under section 515, or an applica-
tion for an exemption under section 520(g), including docu-
mentation 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 super-
visory 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 teleconfer-
ence 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 NOTIFICA-
TION 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 enact-
ment of this paragraph, the Secretary shall submit to the 
Committee on Energy and Commerce of the House of Represent-
atives 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 manufac-
turing process’, and ‘major change or modification in the 
Deadline. 
Reports. 
Decision. 
Deadline. 
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126 STAT. 1053 
PUBLIC LAW 112–144—JULY 9, 2012 
intended use of the device’. The report also shall discuss pos-
sible 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 improve-
ment, and provide reasonable assurance of safety and effective-
ness of modified devices. In developing such report, the Sec-
retary 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 submis-
sion for changes and modifications made to a manufactur-
er’s previously cleared device before the receipt by the 
Committee on Energy and Commerce of the House of Rep-
resentatives 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 Rep-
resentatives 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 appro-
priate, 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 inter-
preted 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— 
Criteria. 
Procedures. 
21 USC 360h–1. 
Continuation. 
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PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 EXEMP-
TIONS. 
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 informa-
tion 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 clin-
ical 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 
Decision. 
Deadline. 
Determination. 
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126 STAT. 1055 
PUBLIC LAW 112–144—JULY 9, 2012 
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 nec-
essary, 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 con-
cerning the proposed reclassification, including— 
Federal Register, 
publication. 
Classification. 
Deadline. 
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126 STAT. 1056 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 classifica-
tion 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 ENACT-
MENT OF THIS ACT.— 
(A) IN GENERAL.—The amendments made by this sub-
section 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 Fed-
eral 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 promul-
gated under subsection (b)’’ and inserting ‘‘an order issued 
21 USC 360c 
note. 
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126 STAT. 1057 
PUBLIC LAW 112–144—JULY 9, 2012 
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, promul-
gated 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 consid-
eration of comments from all affected stake-
holders, including patients, payors, and pro-
viders, 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 para-
graph (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 con-
tain—’’; 
(bb) by redesignating clauses (i) through 
(iv) as subparagraphs (A) through (D), respec-
tively; 
(cc) in subparagraph (A), as so redesig-
nated, by striking ‘‘regulation’’ and inserting 
‘‘order’’; and 
(dd) in subparagraph (C), as so redesig-
nated, 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 regula-
tion’’ and inserting ‘‘(A) issue an administrative 
order under paragraph (1)’’; 
(V) by striking ‘‘paragraph (2)(A)(ii)’’ and 
inserting ‘‘paragraph (2)(B)’’; and 
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126 STAT. 1058 
PUBLIC LAW 112–144—JULY 9, 2012 
(VI) by striking ‘‘promulgation of the regula-
tion’’ 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, not-
withstanding 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 
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126 STAT. 1059 
PUBLIC LAW 112–144—JULY 9, 2012 
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, INSPEC-
TION, 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 appro-
priate, enter into arrangements with nations regarding methods 
and approaches to harmonizing regulatory requirements for activi-
ties, including inspections and common international labeling sym-
bols.’’. 
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 
Deadlines. 
Web posting. 
21 USC 360c–1. 
21 USC 351 note. 
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126 STAT. 1060 
PUBLIC LAW 112–144—JULY 9, 2012 
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 Sec-
retary 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 Sec-
retary shall establish and publish in the Federal Reg-
ister criteria to reaccredit or deny reaccreditation to 
persons under this section. The reaccreditation of per-
sons 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 impos-
sible, highly impracticable, or unsafe.’’; and 
(ii) by striking clause (ii) and inserting the fol-
lowing: 
‘‘(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 reason-
ably 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 subpara-
graph (A)(ii) with respect to a device if additional information 
arises, and the Secretary may modify such annual distribution 
number.’’; 
Determination. 
Definition. 
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126 STAT. 1061 
PUBLIC LAW 112–144—JULY 9, 2012 
(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 IDENTI-
FICATION 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 pri-
vate 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 proce-
dure and device registries. 
‘‘(2) DATA.—In expanding the system as described in para-
graph (1)(A), the Secretary shall use relevant data with respect 
to devices cleared under section 510(k) or approved under sec-
tion 515, including claims data, patient survey data, and any 
other data deemed appropriate by the Secretary. 
Procedures. 
Deadlines. 
Determination. 
21 USC 360j 
note. 
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126 STAT. 1062 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 informa-
tion 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 sur-
veys 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 regula-
tions 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 dis-
tribution; 
‘‘(D) is designed to treat a unique pathology or physio-
logical condition that no other device is domestically avail-
able 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 
Deadline. 
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126 STAT. 1063 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(G) may have common, standardized design character-
istics, chemical and material compositions, and manufac-
turing 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 suffi-
ciently rare condition, such that conducting clinical inves-
tigations 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 com-
plies with this section; and 
‘‘(C) the manufacturer of such device notifies the Sec-
retary 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 para-
graph (2)(B).’’. 
SEC. 618. HEALTH INFORMATION TECHNOLOGY. 
(a) REPORT.—Not later than 18 months after the date of enact-
ment 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 Sec-
retary 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 consulta-
tion with the Commissioner of Food and Drugs, the National 
Coordinator for Health Information Technology, and the Chair-
man of the Federal Communications Commission, shall deter-
mine 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, pur-
chasers, employers, and other stakeholders with relevant exper-
tise, 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— 
Determination. 
Web posting. 
Deadline. 
Notification. 
Deadline. 
Applicability. 
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126 STAT. 1064 
PUBLIC LAW 112–144—JULY 9, 2012 
(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 subpara-
graph.’’. 
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 registra-
tion 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).’’. 
Applicability. 
Time period. 
Deadlines. 
21 USC 360e–1 
note. 
Notification. 
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126 STAT. 1065 
PUBLIC LAW 112–144—JULY 9, 2012 
SEC. 702. REGISTRATION OF FOREIGN ESTABLISHMENTS. 
(a) ENFORCEMENT OF REGISTRATION OF FOREIGN ESTABLISH-
MENTS.—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 busi-
ness 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: 
Applicability. 
Time period. 
21 USC 360. 
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PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 sub-
section 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 elec-
tronic 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 Adminis-
tration 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 establish-
ment 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 des-
ignated 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 establish-
ment pursuant to this section and at least once in every succes-
sive 2-year period thereafter. 
Deadline. 
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PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(3) RISK-BASED
SCHEDULE
FOR
DRUGS.—The Secretary, 
acting through one or more officers or employees duly des-
ignated by the Secretary, shall inspect establishments described 
in paragraph (1) that are engaged in the manufacture, prepara-
tion, 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 sched-
uled under paragraph (3), the Secretary shall inspect establish-
ments according to the known safety risks of such establish-
ments, 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, pre-
pared, 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 govern-
ment recognized under section 809. 
‘‘(F) Any other criteria deemed necessary and appro-
priate 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, com-
pounded, or processed by such establishment are drugs 
described in section 503(b). 
‘‘(6) ANNUAL
REPORT
ON
INSPECTIONS
OF
ESTABLISH-
MENTS.—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 establish-
ments 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 Sec-
retary inspected in the previous fiscal year; 
‘‘(B) with respect to establishments that manufacture, 
prepare, propagate, compound, or process an active ingre-
dient 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: 
Effective date. 
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PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 enact-
ment 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 Serv-
ices 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 testi-
mony on the destruction of a drug, the Secretary of Health and 
Human Services shall store and, as applicable, dispose of the drug 
Regulations. 
Deadline. 
21 USC 351 note. 
Confirmation. 
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126 STAT. 1069 
PUBLIC LAW 112–144—JULY 9, 2012 
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 amend-
ments made this section. 
(2) PROCEDURE.—In promulgating a regulation imple-
menting 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 com-
ments 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 imple-
menting 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 
Time period. 
Notice. 
Deadlines. 
21 USC 334 note. 
21 USC 334. 
Publication. 
Time period. 
Notice. 
Deadlines. 
21 USC 381 note. 
21 USC 381 note. 
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126 STAT. 1070 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 (com-
monly 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 ani-
mals; 
‘‘(B) the information is provided or made available 
to the United States Government voluntarily on the condi-
tion 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 informa-
tion.
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 with-
holding 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. 
Applicability. 
21 USC 334 note. 
Publication. 
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PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(c) AUTHORITY
TO
ENTER
INTO
MEMORANDA
OF
UNDER-
STANDING FOR PURPOSES OF INFORMATION EXCHANGE.—The Sec-
retary 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 writ-
ten 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 pro-
vide information to the foreign government under this sub-
section 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 para-
graph (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 writ-
ten agreement described in paragraph (2) establishes, 
that the government has authority to otherwise obtain 
such information; and 
‘‘(ii) the written agreement executed under para-
graph (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 inves-
tigation, 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 ani-
mals. 
‘‘(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 con-
fidential 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 manu-
facturing 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.’’. 
Definition. 
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PUBLIC LAW 112–144—JULY 9, 2012 
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 per-
formed by a foreign government or an agency of a foreign govern-
ment 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 dem-
onstrating 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 manufac-
turing practice, testing results, certifications relating to satis-
factory inspections, and compliance with the country of export 
regulations; and 
‘‘(D) any other information deemed necessary and appro-
priate by the Secretary to assess compliance of the article 
being offered for import. 
Reviews. 
Audits. 
21 USC 384e. 
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PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 stand-
ards 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 sub-
section. 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 clear-
ance for those importers that volunteer to participate in part-
nership 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 commer-
cial 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. 
Deadlines. 
Publication. 
Time period. 
Notice. 
Deadlines. 
Regulations. 
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PUBLIC LAW 112–144—JULY 9, 2012 
Customs and Border Protection, shall promulgate regula-
tions 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 provi-
sion 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 Home-
land Security acting through U.S. Customs and Border Protec-
tion, 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 provi-
sion of Federal law, in implementing section 801(s) of the 
Federal Food, Drug, and Cosmetic Act, as added by sub-
section (b), the Secretary shall promulgate regulations only 
as described in subparagraph (A). 
Publication. 
Time period. 
Notice. 
Deadlines. 
21 USC 381 note. 
Federal Register, 
publication. 
Applicability. 
Publication. 
Time period. 
Notice. 
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126 STAT. 1075 
PUBLIC LAW 112–144—JULY 9, 2012 
(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 regu-
lated 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 intro-
duced 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 con-
strued 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 know-
ingly 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 
21 USC 
360bbb–7. 
Time period. 
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126 STAT. 1076 
PUBLIC LAW 112–144—JULY 9, 2012 
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 pri-
ority 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 guide-
lines 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 pre-
vent 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; 
Review. 
Guidelines. 
28 USC 994 note. 
18 USC 2320 
note. 
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126 STAT. 1077 
PUBLIC LAW 112–144—JULY 9, 2012 
(C) assure reasonable consistency with other relevant 
directives and with other sentencing guidelines; 
(D) account for any additional aggravating or miti-
gating 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 exten-
sion 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 quali-
fied 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 
21 USC 355f. 
21 USC 337a. 
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126 STAT. 1078 
PUBLIC LAW 112–144—JULY 9, 2012 
infectious disease product at any time before the submission 
of an application under section 505(b) for such drug. The Sec-
retary 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 designa-
tion 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 quali-
fying pathogens described in subsection (f). 
‘‘(2) PROCEDURE.—In promulgating a regulation imple-
menting 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 imple-
menting 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 promulga-
tion 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 Sec-
retary under paragraph (2) that has the potential to pose a 
serious threat to public health, such as— 
‘‘(A) resistant gram positive pathogens, including 
methicillin-resistant Staphylococcus aureus, vancomycin- 
resistant Staphylococcus aureus, and vancomycin-resistant 
enterococcus; 
‘‘(B) multi-drug resistant gram negative bacteria, 
including Acinetobacter, Klebsiella, Pseudomonas, and E. 
coli species; 
‘‘(C) multi-drug resistant tuberculosis; and 
‘‘(D) Clostridium difficile. 
‘‘(2) LIST OF QUALIFYING PATHOGENS.— 
‘‘(A) IN GENERAL.—The Secretary shall establish and 
maintain a list of qualifying pathogens, and shall make 
public the methodology for developing such list. 
Public 
information. 
Publication. 
Time period. 
Notice. 
Deadlines. 
Deadline. 
Determination. 
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126 STAT. 1079 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(B) 
CONSIDERATIONS.—In 
establishing 
and 
maintaining the list of pathogens described under this sec-
tion, 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 orga-
nisms 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 Adminis-
tration, 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 subpara-
graph (A) and shall by regulation revise the list as nec-
essary, 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 life- 
threatening infections, including those caused by— 
‘‘(1) an antibacterial or antifungal resistant pathogen, 
including novel or emerging infectious pathogens; or 
‘‘(2) qualifying pathogens listed by the Secretary under 
subsection (f).’’. 
(b) 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. 
21 USC 360n–1 
note. 
21 USC 360n–1. 
21 USC 355f 
note. 
Definition. 
Time period. 
Publication. 
Regulations. 
Consultation. 
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PUBLIC LAW 112–144—JULY 9, 2012 
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 informa-
tion 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 des-
ignated as a qualified infectious disease product may request 
that the Secretary provide written recommendations for non-
clinical 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 Sec-
retary shall provide the person making the request written 
recommendations for the nonclinical and clinical investigations 
which the Secretary believes, on the basis of information avail-
able 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 
Reports. 
Definition. 
21 USC 360a–1. 
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126 STAT. 1081 
PUBLIC LAW 112–144—JULY 9, 2012 
agencies, submit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report that contains 
the following: 
(1)(A) The number of initial designations of drugs as quali-
fied infectious disease products under section 505E of the Fed-
eral 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 anti-
bacterial and antifungal drugs to treat serious and life-threat-
ening 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 develop-
ment 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 anti-
microbial stewardship protocols across all health care set-
tings. 
(4) Any recommendations for ways to encourage further 
development and establishment of stewardship programs. 
(5) A description of the regulatory challenges and impedi-
ments to clinical development, approval, and licensure of quali-
fied 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 ‘‘quali-
fied 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. 
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126 STAT. 1082 
PUBLIC LAW 112–144—JULY 9, 2012 
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 anti-
bacterial 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. Regu-
latory innovation is 1 element of the Nation’s strategy 
to address serious and life-threatening diseases or condi-
tions 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 med-
ical sciences, including genomics, molecular biology, and 
bioinformatics, have provided an unprecedented under-
standing of the underlying biological mechanism and patho-
genesis of disease. A new generation of modern, targeted 
medicines is under development to treat serious and life- 
threatening diseases, some applying drug development 
strategies based on biomarkers or pharmacogenomics, pre-
dictive toxicology, clinical trial enrichment techniques, and 
novel clinical trial designs, such as adaptive clinical trials. 
(C) As a result of these remarkable scientific and med-
ical advances, the FDA should be encouraged to implement 
more broadly effective processes for the expedited develop-
ment and review of innovative new medicines intended 
to address unmet medical needs for serious or life-threat-
ening diseases or conditions, including those for rare dis-
eases 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 
21 USC 356 note. 
Public comments. 
Deadlines. 
Publication. 
21 USC 355 note. 
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126 STAT. 1083 
PUBLIC LAW 112–144—JULY 9, 2012 
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 gov-
erning expedited approval of drugs for serious or life-threat-
ening 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 develop-
ment 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 life- 
threatening diseases or conditions while maintaining safety 
and effectiveness standards for such treatments. 
(b) EXPEDITED APPROVAL
OF DRUGS
FOR SERIOUS
OR LIFE- 
THREATENING DISEASES OR CONDITIONS.—Section 506 (21 U.S.C. 
356) is amended to read as follows: 
‘‘SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE- 
THREATENING 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 condi-
tion, and it demonstrates the potential to address unmet med-
ical 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 
Deadline. 
Determination. 
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PUBLIC LAW 112–144—JULY 9, 2012 
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 end-
point 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 sub-
section may be subject to 1 or both of the following require-
ments: 
‘‘(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 acceler-
ated 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 post-
approval study of the drug with due diligence; 
‘‘(B) a study required to verify and describe the pre-
dicted 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 pro-
motional 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 Sec-
retary 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 Sec-
retary shall commence such review only if the applicant— 
‘‘(A) provides a schedule for submission of information 
necessary to make the application complete; and 
Evaluation. 
Regulations. 
Records. 
Determination. 
Deadline. 
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PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 applica-
tion is reasonably likely to predict clinical benefit for serious 
or life-threatening conditions for which significant unmet med-
ical 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 con-
strued to alter the standards of evidence under subsection 
(c) or (d) of section 505 (including the substantial evidence 
standard in section 505(d)) of this Act or under section 351(a) 
of the Public Health Service Act. Such sections and standards 
of evidence apply to the review and approval of products under 
this section, including whether a product is safe and effective. 
Nothing in this section alters the ability of the Secretary to 
rely on evidence that does not come from adequate and well- 
controlled investigations for the purpose of determining whether 
an endpoint is reasonably likely to predict clinical benefit as 
described in subsection (b)(1)(B).’’. 
(c) GUIDANCE; AMENDED REGULATIONS.— 
(1) DRAFT 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 sub-
section (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 dis-
eases. 
Deadline. 
21 USC 356 note. 
Applicability. 
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PUBLIC LAW 112–144—JULY 9, 2012 
(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 para-
graph (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 guid-
ance, 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 regula-
tions 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 imple-
menting the amendment made by subsection (b) shall not pre-
clude 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 biopharma-
ceutical 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 sub-
sections (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 
Deadline. 
Public comments. 
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126 STAT. 1087 
PUBLIC LAW 112–144—JULY 9, 2012 
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 break-
through 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 para-
graph (1). If the Secretary finds that the drug meets the 
criteria, the Secretary shall designate the drug as a break-
through therapy and shall take such actions as are appro-
priate to expedite the development and review of the 
application for approval of such drug. 
‘‘(B) ACTIONS.—The actions to expedite the develop-
ment 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 develop-
ment program to gather the nonclinical and clinical 
data necessary for approval is as efficient as prac-
ticable; 
‘‘(iii) involving senior managers and experienced 
review staff, as appropriate, in a collaborative, cross- 
disciplinary review; 
‘‘(iv) assigning a cross-disciplinary project lead for 
the Food and Drug Administration review team to 
facilitate an efficient review of the development pro-
gram 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 sci-
entifically appropriate, such as by minimizing the 
number of patients exposed to a potentially less effica-
cious 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. 
Deadlines. 
21 USC 356 note. 
Deadline. 
Determination. 
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PUBLIC LAW 112–144—JULY 9, 2012 
(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 Sec-
retary 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 regula-
tions implementing the amendments made by this sec-
tion only as described in clause (ii). 
(2) REQUIREMENTS.—Guidance issued under this section 
shall— 
(A) specify the process and criteria by which the Sec-
retary 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 expe-
dite 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 DIS-
EASES, 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 DIS-
EASES, 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 stake-
holders on the topics described in subsection (b). 
‘‘(2) CONSULTATION WITH EXTERNAL EXPERTS.— 
Applicability. 
21 USC 
360bbb–8. 
Publication. 
Time period. 
Notice. 
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126 STAT. 1089 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 tech-
nical expertise necessary for the performance of the Sec-
retary’s regulatory responsibilities and the necessary exper-
tise can be provided by the external experts. 
‘‘(B) EXTERNAL
EXPERTS.—For purposes of subpara-
graph (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 pursu-
ant 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 sec-
tion 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, regula-
tions, and policies governing disclosure of confidential commer-
cial 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 author-
ized 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.— 
Records. 
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126 STAT. 1090 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 identi-
fied 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 investiga-
tional new drug application under section 505(i), a new drug 
application under section 505(b), or a biologics license applica-
tion 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 deter-
mine 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 rep-
resenting the elderly, and industry groups representing stake-
holders, including retail, mail-order, and independent commu-
nity 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 
Deadline. 
29 USC 792 note. 
Applicability. 
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PUBLIC LAW 112–144—JULY 9, 2012 
blind and visually impaired individuals have safe, con-
sistent, 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 con-
sider— 
(A) the use of— 
(i) Braille; 
(ii) auditory means, such as— 
(I) ‘‘talking bottles’’ that provide audible con-
tainer 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 develop-
ment 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 
Effective date. 
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126 STAT. 1092 
PUBLIC LAW 112–144—JULY 9, 2012 
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 Comp-
troller 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 individ-
uals 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 prescrip-
tion 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 con-
tracts 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 APPLICA-
TIONS 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 informa-
tion 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 
Web posting. 
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126 STAT. 1093 
PUBLIC LAW 112–144—JULY 9, 2012 
including sex, age, race, and ethnicity, is included in applica-
tions submitted to the Food and Drug Administration, and 
shall provide such publication to Congress. 
(2) CONTENTS OF REPORT.—The report described in para-
graph (1) shall contain the following: 
(A) A description of existing tools to ensure that data 
to support demographic analyses are submitted in applica-
tions 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, con-
sistent 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 para-
graph (1) shall include— 
(A) recommendations, as appropriate, to improve the 
completeness and quality of analyses of data on demo-
graphic 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; 
Web posting. 
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126 STAT. 1094 
PUBLIC LAW 112–144—JULY 9, 2012 
(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 recommenda-
tion identified in subparagraphs (A) through (C) that distin-
guishes between product types referenced in subsection 
(a)(2)(B) insofar as the applicability of each such rec-
ommendation 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 Sec-
retary 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 cri-
teria: 
‘‘(A) The disease primarily affects individuals aged from 
birth to 18 years, including age groups often called neo-
nates, 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— 
Deadline. 
21 USC 360ff. 
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126 STAT. 1095 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 pedi-
atric disease product application. 
‘‘(2) TRANSFERABILITY.— 
‘‘(A) IN GENERAL.—The sponsor of a rare pediatric dis-
ease 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 trans-
ferred 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 applica-
tion 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 
Deadline. 
Time period. 
Deadline. 
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126 STAT. 1096 
PUBLIC LAW 112–144—JULY 9, 2012 
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 pri-
ority 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 Sep-
tember 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 notifica-
tion 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, exemp-
tion, 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 collec-
tions 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— 
Effective date. 
Time period. 
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126 STAT. 1097 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 designa-
tion 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 pre-
requisite to receiving a priority review voucher under this sec-
tion. 
‘‘(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 pedi-
atric 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 
Time period. 
Federal Register, 
publication. 
Web posting. 
Time period. 
Deadline. 
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126 STAT. 1098 
PUBLIC LAW 112–144—JULY 9, 2012 
for a drug uses a priority review voucher under this section 
for such application, the Secretary shall submit to the Com-
mittee on Energy and Commerce of the House of Representa-
tives 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 dis-
eases. 
‘‘(i) GAO STUDY AND REPORT.— 
‘‘(1) STUDY.— 
‘‘(A) IN GENERAL.—Beginning on the date that the Sec-
retary 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 pedi-
atric 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 Represent-
atives and the Committee on Health, Education, Labor, and 
Pensions of the Senate, a report containing the results of the 
study under paragraph (1).’’. 
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126 STAT. 1099 
PUBLIC LAW 112–144—JULY 9, 2012 
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 PRODUC-
TION 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 interrup-
tion 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 con-
strued 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 con-
trolled 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 
Notification. 
Deadline. 
Determination. 
Notification. 
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126 STAT. 1100 
PUBLIC LAW 112–144—JULY 9, 2012 
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 con-
trolled 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 supple-
ment 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 establish-
ment 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’— 
Notifications. 
Deadlines. 
Public 
information. 
Web posting. 
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126 STAT. 1101 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 sec-
tion 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 Sec-
retary 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 pro-
gram of such Centers; and 
‘‘(ii) explain the determination made by the Sec-
retary under clause (i) in the regulation. 
‘‘(4) PROCEDURE.—In promulgating a regulation imple-
menting 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 con-
strued— 
21 USC 356c 
note. 
Publication. 
Time period. 
Notice. 
Determination. 
Definitions. 
Deadline. 
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126 STAT. 1102 
PUBLIC LAW 112–144—JULY 9, 2012 
(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 inves-
tigators 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 re-
inspections 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 regu-
latory 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.’’. 
Study. 
21 USC 356c–1. 
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126 STAT. 1103 
PUBLIC LAW 112–144—JULY 9, 2012 
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 intra- 
agency coordination, communication, and decision-
making; 
‘‘(ii) plans for ensuring that drug shortages are 
considered when the Secretary initiates a regulatory 
action that could precipitate a drug shortage or exacer-
bate an existing drug shortage; 
‘‘(iii) plans for effective communication with out-
side 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 short-
ages 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 nec-
essary 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 appro-
priate 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 
21 USC 356d. 
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126 STAT. 1104 
PUBLIC LAW 112–144—JULY 9, 2012 
and Human Services with expertise regarding drug short-
ages. The Secretary shall engage external stakeholders and 
experts as appropriate. 
‘‘(2) TIMING.—Not later than 1 year after the date of enact-
ment of the Food and Drug Administration Safety and Innova-
tion 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 communica-
tion 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 iden-
tify 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 fol-
lowing: 
‘‘SEC. 506E. DRUG SHORTAGE LIST. 
‘‘(a) ESTABLISHMENT.—The Secretary shall maintain an up-to- 
date list of drugs that are determined by the Secretary to be 
in shortage in the United States. 
‘‘(b) 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. 
21 USC 356e. 
Determination. 
Evaluation. 
Publication. 
Submission. 
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126 STAT. 1105 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 avail-
able. 
‘‘(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 prod-
ucts 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 sub-
stance 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 deter-
mination. 
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 Rep-
resentatives 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, 
21 USC 826a. 
Public 
information. 
Web posting. 
Determination. 
Review. 
Deadline. 
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126 STAT. 1106 
PUBLIC LAW 112–144—JULY 9, 2012 
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 Enforce-
ment Administration and Food and Drug Administration on 
efforts to prevent or alleviate drug shortages; and 
(3) identifies drugs containing a controlled substance sub-
ject 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 fol-
lowing: 
‘‘SEC. 506F. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) DRUG.—The term ‘drug’ excludes any controlled sub-
stance (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 
21 USC 356f. 
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126 STAT. 1107 
PUBLIC LAW 112–144—JULY 9, 2012 
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 formu-
late recommendations on how to prevent or alleviate such shortages. 
(b) CONSIDERATION.—In conducting the study under this sec-
tion, 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 thera-
peutic areas? 
(4)(A) How have regulations, guidance documents, regu-
latory practices, policies, and other actions of Federal depart-
ments and agencies (including the effectiveness of interagency 
and intra-agency coordination, communication, strategic plan-
ning, and decisionmaking), including those used to enforce 
statutory requirements, affected drug shortages? 
(B) Do any such regulations, guidances, policies, or prac-
tices 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 subpara-
graph (C) have on the public health? 
(5) How does hoarding affect drug shortages? 
(6) How would incentives alleviate or prevent drug short-
ages? 
(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 enforce-
ment 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 rec-
ommendations to increase communication and coordination 
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126 STAT. 1108 
PUBLIC LAW 112–144—JULY 9, 2012 
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, hos-
pitals, 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 EXCLU-
SIVITY 
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-PRI-
VATE 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. 
21 USC 360ddd. 
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126 STAT. 1109 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 accord-
ance 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, nonlique-
fied, 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 Sec-
retary a request for certification of a medical gas as a des-
ignated medical gas. Any such request shall contain the fol-
lowing 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 des-
ignated 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 indica-
tions for use: 
Time period. 
Effective date. 
21 USC 
360ddd–1. 
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126 STAT. 1110 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 des-
ignated medical gas or combination of designated 
medical gases deemed appropriate by the Sec-
retary, 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 con-
cerning 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 with-
draw or suspend approval of a drug product, including 
a designated medical gas deemed under this section to 
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126 STAT. 1111 
PUBLIC LAW 112–144—JULY 9, 2012 
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 certifi-
cation 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 prescrip-
tion 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 sub-
section (a) that changes to the Federal drug regulations are nec-
essary 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: 
Determination. 
21 USC 
360ddd note. 
21 USC 
360ddd–2. 
Determination. 
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126 STAT. 1112 
PUBLIC LAW 112–144—JULY 9, 2012 
(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 speci-
fied 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 subpara-
graph (H) of section 575(1) of such Act for an indication that— 
(A) is not included in, or is different from, those origi-
nally 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 guid-
ance that describes Food and Drug Administration policy regarding 
the promotion, using the Internet (including social media), of med-
ical 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 appro-
priate, 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 
Web posting. 
Deadline. 
21 USC 379d–5. 
21 USC 
360ddd note. 
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126 STAT. 1113 
PUBLIC LAW 112–144—JULY 9, 2012 
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 central-
ized data clearinghouse and early warning tool; 
(2) how best to develop and disseminate widely best prac-
tices 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 
21 USC 
360bbb–8b. 
21 USC 
360bbb–8a. 
Deadline. 
21 USC 355 note. 
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126 STAT. 1114 
PUBLIC LAW 112–144—JULY 9, 2012 
the European Union, if the applicant demonstrates that such data 
are adequate under applicable standards to support approval, licen-
sure, or clearance of the drug or device in the United States. 
‘‘(b) NOTICE TO SPONSOR.—If the Secretary finds under sub-
section (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 enact-
ment 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 commit-
ment 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 effi-
cient, 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 mis-
sion of the agency with respect to decisionmaking concerning 
medical products and allocation of resources toward such regu-
latory 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 identi-
fied under paragraph (3) will be measured by the Food and 
Drug Administration, including metrics specific to the integra-
tion and adoption of advances in regulatory science described 
in paragraph (5) and improving medical product decision-
making, 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 
Deadline. 
21 USC 393 note. 
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126 STAT. 1115 
PUBLIC LAW 112–144—JULY 9, 2012 
the Food and Drug Administration, including by senior man-
agers 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 sec-
tion 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 Agree-
ment 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; 
21 USC 393 note. 
Definition. 
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126 STAT. 1116 
PUBLIC LAW 112–144—JULY 9, 2012 
(C) the ways in which the Food and Drug Administra-
tion uses the plan described in subparagraph (A) to guide 
and coordinate the modernization projects and activities 
of the Food and Drug Administration, including the inter-
dependencies among projects and activities; and 
(D) the extent to which the Food and Drug Administra-
tion 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 plan-
ning. 
(b) GAO REPORT.—Not later than January 1, 2016, the Comp-
troller 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 comprehen-
sive 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 tech-
nology 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 Account-
ability Office with respect to such agency and information tech-
nology. 
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 prod-
ucts 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 regula-
tion 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 sys-
tems, and the interaction of such nanomaterials with biological 
systems. 
(b) ACTIVITIES.—In conducting activities related to nanotechnol-
ogy, the Secretary may— 
21 USC 399e. 
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126 STAT. 1117 
PUBLIC LAW 112–144—JULY 9, 2012 
(1) assess scientific literature and data on general nano-
materials 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 nanomate-
rials 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 fur-
ther the understanding of measurement and detection methods 
for nanomaterials; 
(5) collect, synthesize, interpret, and disseminate scientific 
information and data related to the interactions of nanomate-
rials 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 nano-
materials 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 partici-
pate in international and national consensus standards activi-
ties 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 phar-
macy Internet Web sites; 
(3) efforts by the Federal Government and State and local 
governments to investigate and prosecute the owners or opera-
tors 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 govern-
ments have experienced in investigating and prosecuting such 
cases; 
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126 STAT. 1118 
PUBLIC LAW 112–144—JULY 9, 2012 
(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 opera-
tors 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 con-
sumers 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.’’. 
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126 STAT. 1119 
PUBLIC LAW 112–144—JULY 9, 2012 
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 Evalua-
tion 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 Bio-
logics 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 modifica-
tion 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,’’; 
Deadline. 
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126 STAT. 1120 
PUBLIC LAW 112–144—JULY 9, 2012 
(B) in subparagraph (C), by striking ‘‘new safety or 
effectiveness information indicates that’’ and all that fol-
lows and inserting the following: ‘‘an assessment is needed 
to evaluate whether the approved strategy should be modi-
fied 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, modifica-
tion, 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 Sec-
retary, the Secretary may, at any time, require a respon-
sible 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 MODIFICA-
TIONS’’ 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 pro-
posed strategy, assessment, or modification’’ after ‘‘sub-
section (g)’’; 
(3) by striking paragraph (2); 
(4) by redesignating paragraphs (3) through (9) as para-
graphs (2) through (8), respectively; 
(5) in paragraph (2), as redesignated by paragraph (4)— 
Deadline. 
Proposal. 
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126 STAT. 1121 
PUBLIC LAW 112–144—JULY 9, 2012 
(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 sec-
tion 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 imple-
ment certain modifications to an approved risk evalua-
tion 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 modi-
fication to a risk evaluation and mitigation strategy under 
subparagraph (A), the Secretary shall make publicly avail-
able 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 require-
ments of scheduling review by the Drug Safety Over-
sight 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)— 
Deadlines. 
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126 STAT. 1122 
PUBLIC LAW 112–144—JULY 9, 2012 
(A) in subparagraph (A), by striking ‘‘any of subpara-
graphs (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 enact-
ment 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-DAY- 
EXCLUSIVITY 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 certifi-
cation, 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 enact-
ment 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 applica-
tion 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)). 
21 USC 355 note. 
Deadline. 
21 USC 355–1 
note. 
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126 STAT. 1123 
PUBLIC LAW 112–144—JULY 9, 2012 
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 regula-
tions), no later than 270 days after the date the petition is sub-
mitted.’’. 
(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 Sec-
retary in such guidance. 
Effective date. 
21 USC 379k–1. 
21 USC 355 note. 
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126 STAT. 1124 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(2) GUIDANCE CONTENTS.—In the guidance under para-
graph (1), the Secretary may— 
‘‘(A) provide a timetable for establishment by the Sec-
retary 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 submis-
sions 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 supple-
ments to such presubmissions or submissions, shall include 
an electronic copy of such presubmissions or submissions. 
‘‘(2) GUIDANCE CONTENTS.—In the guidance under para-
graph (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 DISCUS-
SIONS. 
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 DISCUS-
SION. 
‘‘(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 investiga-
tors; 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 
21 USC 
360bbb–8c. 
Effective date. 
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126 STAT. 1125 
PUBLIC LAW 112–144—JULY 9, 2012 
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 PHARMA-
CEUTICALS 
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 sub-
section (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 profes-
sionals and patients, any information identifying particular 
subpopulations, and any other relevant information as deter-
mined 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 nec-
essary. 
(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 commu-
nication 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 
Deadline. 
21 USC 399f. 
Definition. 
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126 STAT. 1126 
PUBLIC LAW 112–144—JULY 9, 2012 
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 connec-
tion 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 preven-
tion 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 con-
ducted 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 inter-
operability 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 Pro-
gram 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 estab-
lished under section 399O of the Public Health Service Act 
(42 U.S.C. 280g–3). 
(b) REQUIREMENTS.—The Secretary of Health and Human Serv-
ices shall consider the following in facilitating the development 
of recommendations on interoperability of prescription drug moni-
toring programs under subsection (a)— 
(1) open standards that are freely available, without cost 
and without restriction, in order to promote broad implementa-
tion; 
Web posting. 
Deadline. 
Public meeting. 
Evaluation. 
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126 STAT. 1127 
PUBLIC LAW 112–144—JULY 9, 2012 
(2) the use of exchange intermediaries, or hubs, as nec-
essary to facilitate interstate interoperability by accommodating 
State-to-hub, hub-to-hub, and direct State-to-State communica-
tion; 
(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 informa-
tion 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 interoper-
ability; 
(B) a discussion of how State prescription drug moni-
toring programs could increase the production and distribu-
tion 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 mon-
itoring 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 out-
reach to potential members of advisory committees at 
universities, colleges, other academic research centers, 
professional and medical societies, and patient and con-
sumer groups; 
‘‘(B) seek input from professional medical and scientific 
societies to determine the most effective informational and 
recruitment activities; 
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126 STAT. 1128 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(C) at least every 180 days, request referrals for poten-
tial 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 con-
ferences; 
‘‘(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 Cen-
ters 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 Sec-
retary 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 Sec-
retary 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 
Applicability. 
Deadlines. 
Web posting. 
Time period. 
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126 STAT. 1129 
PUBLIC LAW 112–144—JULY 9, 2012 
to which a written determination as referred to in section 
208(b)(1) of title 18, United States Code, or a written certifi-
cation 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 Represent-
atives, 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 com-
mittee 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 
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126 STAT. 1130 
PUBLIC LAW 112–144—JULY 9, 2012 
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 par-
ticular matter.’’. 
(b) APPLICABILITY.—The amendments made by subsection (a) 
apply beginning on October 1, 2012. 
SEC. 1143. NOTIFICATION OF FDA INTENT TO REGULATE LABORATORY- 
DEVELOPED TESTS. 
(a) IN GENERAL.—The Food and Drug Administration may not 
issue any draft or final guidance on the regulation of laboratory- 
developed tests under the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.) without, at least 60 days prior to such 
issuance— 
(1) notifying the Committee on Energy and Commerce of 
the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate of the Administra-
tion’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 Preven-
tion 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 sec-
tion 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 sub-
stance 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. 
Definition. 
21 USC 801 note. 
Synthetic Drug 
Abuse Prevention 
Act of 2012. 
Time period. 
21 USC 371 note. 
Effective date. 
21 USC 379d–1 
note. 
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126 STAT. 1131 
PUBLIC LAW 112–144—JULY 9, 2012 
‘‘(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 substi-
tution 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 Con-
trolled 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). 
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126 STAT. 1132 
PUBLIC LAW 112–144—JULY 9, 2012 
LEGISLATIVE HISTORY—S. 3187: 
CONGRESSIONAL RECORD, Vol. 158 (2012): 
May 23, 24, considered and passed Senate. 
June 20, considered and passed House, amended. 
June 21, 25, 26, Senate considered and concurred in House amendment. 
‘‘(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’’. 
Approved July 9, 2012. 
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