[United States Statutes at Large, Volume 126, 112th Congress, 2nd Session]
[From the U.S. Government Publishing Office, www.gpo.gov]
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 generic drugs.
Sec. 308. Additional reporting requirements.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Sec. 401. Short title; finding.
Sec. 402. Fees relating to biosimilar biological products.
[[Page 994]]
Sec. 403. Reauthorization; reporting requirements.
Sec. 404. Sunset dates.
Sec. 405. Effective date.
Sec. 406. Savings clause.
Sec. 407. Conforming amendment.
Sec. 408. Additional reporting requirements.
TITLE V--PEDIATRIC DRUGS AND DEVICES
Sec. 501. Permanence.
Sec. 502. Written requests.
Sec. 503. Communication with Pediatric Review Committee.
Sec. 504. Access to data.
Sec. 505. Ensuring the completion of pediatric studies.
Sec. 506. Pediatric study plans.
Sec. 507. Reauthorizations.
Sec. 508. Report.
Sec. 509. Technical amendments.
Sec. 510. Pediatric rare diseases.
Sec. 511. Staff of Office of Pediatric Therapeutics.
TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS
Sec. 601. Investigational device exemptions.
Sec. 602. Clarification of least burdensome standard.
Sec. 603. Agency documentation and review of significant decisions.
Sec. 604. Device modifications requiring premarket notification prior to
marketing.
Sec. 605. Program to improve the device recall system.
Sec. 606. Clinical holds on investigational device exemptions.
Sec. 607. Modification of de novo application process.
Sec. 608. Reclassification procedures.
Sec. 609. Harmonization of device premarket review, inspection, and
labeling symbols.
Sec. 610. Participation in international fora.
Sec. 611. Reauthorization of third-party review.
Sec. 612. Reauthorization of third-party inspection.
Sec. 613. Humanitarian device exemptions.
Sec. 614. Unique device identifier.
Sec. 615. Sentinel.
Sec. 616. Postmarket surveillance.
Sec. 617. Custom devices.
Sec. 618. Health information technology.
Sec. 619. Good guidance practices relating to devices.
Sec. 620. Pediatric device consortia.
TITLE VII--DRUG SUPPLY CHAIN
Sec. 701. Registration of domestic drug establishments.
Sec. 702. Registration of foreign establishments.
Sec. 703. Identification of drug excipient information with product
listing.
Sec. 704. Electronic system for registration and listing.
Sec. 705. Risk-based inspection frequency.
Sec. 706. Records for inspection.
Sec. 707. Prohibition against delaying, denying, limiting, or refusing
inspection.
Sec. 708. Destruction of adulterated, misbranded, or counterfeit drugs
offered for import.
Sec. 709. Administrative detention.
Sec. 710. Exchange of information.
Sec. 711. Enhancing the safety and quality of the drug supply.
Sec. 712. Recognition of foreign government inspections.
Sec. 713. Standards for admission of imported drugs.
Sec. 714. Registration of commercial importers.
Sec. 715. Notification.
Sec. 716. Protection against intentional adulteration.
Sec. 717. Penalties for counterfeiting drugs.
Sec. 718. Extraterritorial jurisdiction.
TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW
Sec. 801. Extension of exclusivity period for drugs.
Sec. 802. Priority review.
Sec. 803. Fast track product.
Sec. 804. Clinical trials.
Sec. 805. Reassessment of qualified infectious disease product
incentives in 5 years.
Sec. 806. Guidance on pathogen-focused antibacterial drug development.
[[Page 995]]
TITLE IX--DRUG APPROVAL AND PATIENT ACCESS
Sec. 901. Enhancement of accelerated patient access to new medical
treatments.
Sec. 902. Breakthrough therapies.
Sec. 903. Consultation with external experts on rare diseases, targeted
therapies, and genetic targeting of treatments.
Sec. 904. Accessibility of information on prescription drug container
labels by visually impaired and blind consumers.
Sec. 905. Risk-benefit framework.
Sec. 906. Grants and Contracts for the Development of Orphan Drugs.
Sec. 907. Reporting of inclusion of demographic subgroups in clinical
trials and data analysis in applications for drugs,
biologics, and devices.
Sec. 908. Rare pediatric disease priority review voucher incentive
program.
TITLE X--DRUG SHORTAGES
Sec. 1001. Discontinuance or interruption in the production of life-
saving drugs.
Sec. 1002. Annual reporting on drug shortages.
Sec. 1003. Coordination; task force and strategic plan.
Sec. 1004. Drug shortage list.
Sec. 1005. Quotas applicable to drugs in shortage.
Sec. 1006. Attorney General report on drug shortages.
Sec. 1007. Hospital repackaging of drugs in shortage.
Sec. 1008. Study on drug shortages.
TITLE XI--OTHER PROVISIONS
Subtitle A--Reauthorizations
Sec. 1101. Reauthorization of provision relating to exclusivity of
certain drugs containing single enantiomers.
Sec. 1102. Reauthorization of the critical path public-private
partnerships.
Subtitle B--Medical Gas Product Regulation
Sec. 1111. Regulation of medical gases.
Sec. 1112. Changes to regulations.
Sec. 1113. Rules of construction.
Subtitle C--Miscellaneous Provisions
Sec. 1121. Guidance document regarding product promotion using the
Internet.
Sec. 1122. Combating prescription drug abuse.
Sec. 1123. Optimizing global clinical trials.
Sec. 1124. Advancing regulatory science to promote public health
innovation.
Sec. 1125. Information technology.
Sec. 1126. Nanotechnology.
Sec. 1127. Online pharmacy report to Congress.
Sec. 1128. Report on small businesses.
Sec. 1129. Protections for the commissioned corps of the public health
service act.
Sec. 1130. Compliance date for rule relating to sunscreen drug products
for over-the-counter human use.
Sec. 1131. Strategic integrated management plan.
Sec. 1132. Assessment and modification of REMS.
Sec. 1133. Extension of period for first applicant to obtain tentative
approval without forfeiting 180-day-exclusivity period.
Sec. 1134. Deadline for determination on certain petitions.
Sec. 1135. Final agency action relating to petitions and civil actions.
Sec. 1136. Electronic submission of applications.
Sec. 1137. Patient participation in medical product discussions.
Sec. 1138. Ensuring adequate information regarding pharmaceuticals for
all populations, particularly underrepresented
subpopulations, including racial subgroups.
Sec. 1139. Scheduling of hydrocodone.
Sec. 1140. Study on Drug Labeling by Electronic Means.
Sec. 1141. Recommendations on interoperability standards.
Sec. 1142. Conflicts of interest.
Sec. 1143. Notification of FDA intent to regulate laboratory-developed
tests.
Subtitle D--Synthetic Drugs
Sec. 1151. Short title.
Sec. 1152. Addition of synthetic drugs to schedule I of the Controlled
Substances Act.
Sec. 1153. Temporary scheduling to avoid imminent hazards to public
safety expansion.
[[Page 996]]
(b) References in Act.--Except as otherwise specified, amendments
made by this Act to a section or other provision of law are amendments
to such section or other provision of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).
TITLE I--FEES <> RELATING TO DRUGS
SEC. 101. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Prescription Drug
User Fee Amendments of 2012''.
(b) <> Finding.--The Congress finds that
the fees authorized by the amendments made in this title will be
dedicated toward expediting the drug development process and the process
for the review of human drug applications, including postmarket drug
safety activities, as set forth in the goals identified for purposes of
part 2 of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act, in the letters from the Secretary of Health and Human
Services to the Chairman of the Committee on Health, Education, Labor,
and Pensions of the Senate and the Chairman of the Committee on Energy
and Commerce of the House of Representatives, as set forth in the
Congressional Record.
SEC. 102. DEFINITIONS.
Section 735(7) (21 U.S.C. 379g) is amended by striking ``expenses
incurred in connection with'' and inserting ``expenses in connection
with''.
SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.
Section 736 (21 U.S.C. 379h) is amended--
(1) in subsection (a)--
(A) in the matter preceding paragraph (1), by
striking ``fiscal year 2008'' and inserting ``fiscal
year 2013'';
(B) in paragraph (1)(A)--
(i) in clause (i), by striking ``(c)(5)'' and
inserting ``(c)(4)''; and
(ii) in clause (ii), by striking ``(c)(5)''
and inserting ``(c)(4)'';
(C) in the matter following clause (ii) in paragraph
(2)(A)--
(i) by striking ``(c)(5)'' and inserting
``(c)(4)''; and
(ii) by striking ``payable on or before
October 1 of each year'' and inserting ``due on
the later of the first business day on or after
October 1 of each fiscal year or the first
business day after the enactment of an
appropriations Act providing for the collection
and obligation of fees for such fiscal year under
this section'';
(D) in paragraph (3)--
(i) in subparagraph (A)--
(I) by striking ``subsection
(c)(5)'' and inserting ``subsection
(c)(4)''; and
(II) by striking ``payable on or
before October 1 of each year.'' and
inserting ``due on the later of the
first business day on or after October 1
of each fiscal year or the first
business day after the enactment of an
appropriations Act providing
[[Page 997]]
for the collection and obligation of
fees for such fiscal year under this
section.''; and
(ii) by amending subparagraph (B) to read as
follows:
``(B) Exception.--A prescription drug product shall
not be assessed a fee under subparagraph (A) if such
product is--
``(i) identified on the list compiled under
section 505(j)(7) with a potency described in
terms of per 100 mL;
``(ii) the same product as another product
that--
``(I) was approved under an
application filed under section 505(b)
or 505(j); and
``(II) is not in the list of
discontinued products compiled under
section 505(j)(7);
``(iii) the same product as another product
that was approved under an abbreviated application
filed under section 507 (as in effect on the day
before the date of enactment of the Food and Drug
Administration Modernization Act of 1997); or
``(iv) the same product as another product
that was approved under an abbreviated new drug
application pursuant to regulations in effect
prior to the implementation of the Drug Price
Competition and Patent Term Restoration Act of
1984.'';
(2) in subsection (b)--
(A) in paragraph (1)--
(i) in the matter preceding subparagraph (A),
by striking ``fiscal years 2008 through 2012'' and
inserting ``fiscal years 2013 through 2017'';
(ii) in subparagraph (A), by striking
``$392,783,000; and'' and inserting
``$693,099,000;''; and
(iii) by striking subparagraph (B) and
inserting the following:
``(B) the dollar amount equal to the inflation
adjustment for fiscal year 2013 (as determined under
paragraph (3)(A)); and
``(C) the dollar amount equal to the workload
adjustment for fiscal year 2013 (as determined under
paragraph (3)(B)).''; and
(B) by striking paragraphs (3) and (4) and inserting
the following:
``(3) Fiscal year 2013 inflation and workload adjustments.--
For purposes of paragraph (1), the dollar amount of the
inflation and workload adjustments for fiscal year 2013 shall be
determined as follows:
``(A) Inflation adjustment.--The inflation
adjustment for fiscal year 2013 shall be the sum of--
``(i) $652,709,000 multiplied by the result of
an inflation adjustment calculation determined
using the methodology described in subsection
(c)(1)(B); and
``(ii) $652,709,000 multiplied by the result
of an inflation adjustment calculation determined
using the methodology described in subsection
(c)(1)(C).
``(B) Workload adjustment.--Subject to subparagraph
(C), the workload adjustment for fiscal 2013 shall be--
[[Page 998]]
``(i) $652,709,000 plus the amount of the
inflation adjustment calculated under subparagraph
(A); multiplied by
``(ii) the amount (if any) by which a
percentage workload adjustment for fiscal year
2013, as determined using the methodology
described in subsection (c)(2)(A), would exceed
the percentage workload adjustment (as so
determined) for fiscal year 2012, if both such
adjustment percentages were calculated using the
5-year base period consisting of fiscal years 2003
through 2007.
``(C) Limitation.--Under no circumstances shall the
adjustment under subparagraph (B) result in fee revenues
for fiscal year 2013 that are less than the sum of the
amount under paragraph (1)(A) and the amount under
paragraph (1)(B).'';
(3) by striking subsection (c) and inserting the following:
``(c) Adjustments.--
``(1) Inflation adjustment.-- <> For fiscal year 2014 and subsequent
fiscal years, the revenues established in subsection (b) shall
be adjusted by the Secretary by notice, published in the Federal
Register, for a fiscal year by the amount equal to the sum of--
``(A) one;
``(B) the average annual percent change in the cost,
per full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and
benefits paid with respect to such positions for the
first 3 years of the preceding 4 fiscal years,
multiplied by the proportion of personnel compensation
and benefits costs to total costs of the process for the
review of human drug applications (as defined in section
735(6)) for the first 3 years of the preceding 4 fiscal
years, and
``(C) the average annual percent change that
occurred in the Consumer Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not Seasonally
Adjusted; All items; Annual Index) for the first 3 years
of the preceding 4 years of available data multiplied by
the proportion of all costs other than personnel
compensation and benefits costs to total costs of the
process for the review of human drug applications (as
defined in section 735(6)) for the first 3 years of the
preceding 4 fiscal years.
The adjustment made each fiscal year under this paragraph shall
be added on a compounded basis to the sum of all adjustments
made each fiscal year after fiscal year 2013 under this
paragraph.
``(2) Workload adjustment.--For fiscal year 2014 and
subsequent fiscal years, after the fee revenues established in
subsection (b) are adjusted for a fiscal year for inflation in
accordance with paragraph (1), the fee revenues shall be
adjusted further for such fiscal year to reflect changes in the
workload of the Secretary for the process for the review of
human drug applications. With respect to such adjustment:
``(A) <> The
adjustment shall be determined by the Secretary based on
a weighted average of the change in the total number of
human drug applications (adjusted for
[[Page 999]]
changes in review activities, as described in the notice
that the Secretary is required to publish in the Federal
Register under this subparagraph), efficacy supplements,
and manufacturing supplements submitted to the
Secretary, and the change in the total number of active
commercial investigational new drug applications
(adjusted for changes in review activities, as so
described) during the most recent 12-month period for
which data on such submissions is
available. <> The
Secretary shall publish in the Federal Register the fee
revenues and fees resulting from the adjustment and the
supporting methodologies.
``(B) Under no circumstances shall the adjustment
result in fee revenues for a fiscal year that are less
than the sum of the amount under subsection (b)(1)(A)
and the amount under subsection (b)(1)(B), as adjusted
for inflation under paragraph (1).
``(C) <> The
Secretary shall contract with an independent accounting
or consulting firm to periodically review the adequacy
of the adjustment and publish the results of those
reviews. The first review shall be conducted and
published by the end of fiscal year 2013 (to examine the
performance of the adjustment since fiscal year 2009),
and the second review shall be conducted and published
by the end of fiscal year 2015 (to examine the continued
performance of the adjustment). <> The
reports shall evaluate whether the adjustment reasonably
represents actual changes in workload volume and
complexity and present options to discontinue, retain,
or modify any elements of the
adjustment. <> The
reports shall be published for public comment. After
review of the reports and receipt of public comments,
the Secretary shall, if warranted, adopt appropriate
changes to the methodology. <> If
the Secretary adopts changes to the methodology based on
the first report, the changes shall be effective for the
first fiscal year for which fees are set after the
Secretary adopts such changes and each subsequent fiscal
year.
``(3) Final year adjustment.--For fiscal year 2017, the
Secretary may, in addition to adjustments under this paragraph
and paragraphs (1) and (2), further increase the fee revenues
and fees established in subsection (b) if such an adjustment is
necessary to provide for not more than 3 months of operating
reserves of carryover user fees for the process for the review
of human drug applications for the first 3 months of fiscal year
2018. If such an adjustment is necessary, the rationale for the
amount of the increase shall be contained in the annual notice
establishing fee revenues and fees for fiscal year 2017. If the
Secretary has carryover balances for such process in excess of 3
months of such operating reserves, the adjustment under this
paragraph shall not be made.
``(4) Annual fee setting.-- <> The
Secretary shall, not later than 60 days before the start of each
fiscal year that begins after September 30, 2012, establish, for
the next fiscal year, application, product, and establishment
fees under subsection (a), based on the revenue amounts
established under subsection (b) and the adjustments provided
under this subsection.
``(5) Limit.--The total amount of fees charged, as adjusted
under this subsection, for a fiscal year may not exceed the
[[Page 1000]]
total costs for such fiscal year for the resources allocated for
the process for the review of human drug applications.''; and
(4) in subsection (g)--
(A) in paragraph (1), by striking ``Fees
authorized'' and inserting ``Subject to paragraph
(2)(C), fees authorized'';
(B) in paragraph (2)--
(i) in subparagraph (A)(i), by striking
``shall be retained'' and inserting ``subject to
subparagraph (C), shall be collected and
available'';
(ii) in subparagraph (A)(ii), by striking
``shall only be collected and available'' and
inserting ``shall be available''; and
(iii) by adding at the end the following new
subparagraph:
``(C) Provision for early payments.--Payment of fees
authorized under this section for a fiscal year, prior
to the due date for such fees, may be accepted by the
Secretary in accordance with authority provided in
advance in a prior year appropriations Act.'';
(C) in paragraph (3), by striking ``fiscal years
2008 through 2012'' and inserting ``fiscal years 2013
through 2017''; and
(D) in paragraph (4)--
(i) by striking ``fiscal years 2008 through
2010'' and inserting ``fiscal years 2013 through
2015'';
(ii) by striking ``fiscal year 2011'' and
inserting ``fiscal year 2016'';
(iii) by striking ``fiscal years 2008 through
2011'' and inserting ``fiscal years 2013 through
2016''; and
(iv) by striking ``fiscal year 2012'' and
inserting ``fiscal year 2017''.
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 736B (21 U.S.C. 379h-2) is amended--
(1) by amending subsection (a) to read as follows:
``(a) Performance Report.--
``(1) In general.-- <> Beginning with
fiscal year 2013, not later than 120 days after the end of each
fiscal year for which fees are collected under this part, the
Secretary shall prepare and submit to the Committee on Energy
and Commerce of the House of Representatives and the Committee
on Health, Education, Labor, and Pensions of the Senate a report
concerning--
``(A) the progress of the Food and Drug
Administration in achieving the goals identified in the
letters described in section 101(b) of the Prescription
Drug User Fee Amendments of 2012 during such fiscal year
and the future plans of the Food and Drug Administration
for meeting the goals, including the status of the
independent assessment described in such letters; and
``(B) the progress of the Center for Drug Evaluation
and Research and the Center for Biologics Evaluation and
Research in achieving the goals, and future plans for
meeting the goals, including, for each review division--
``(i) the number of original standard new drug
applications and biologics license applications
filed per fiscal year for each review division;
[[Page 1001]]
``(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.
[[Page 1002]]
(3) Effective September 30, 1997, section 105 of the
Prescription Drug User Fee Act of 1992 (Public Law 102-
571) <> is repealed.
SEC. 106. <> EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2012, or the date of the enactment of this Act, whichever is later,
except that fees under part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all human
drug applications received on or after October 1, 2012, regardless of
the date of the enactment of this Act.
SEC. 107. <> SAVINGS CLAUSE.
<> Notwithstanding the amendments
made by this title, part 2 of subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act, as in effect on the day before the date of
the enactment of this title, shall continue to be in effect with respect
to human drug applications and supplements (as defined in such part as
of such day) that on or after October 1, 2007, but before October 1,
2012, were accepted by the Food and Drug Administration for filing with
respect to assessing and collecting any fee required by such part for a
fiscal year prior to fiscal year 2012.
TITLE II-- <> FEES
RELATING TO DEVICES
SEC. 201. SHORT TITLE; FINDINGS.
(a) Short Title.-- <> This title may be
cited as the ``Medical Device User Fee Amendments of 2012''.
(b) Findings.-- <> The Congress finds that
the fees authorized under the amendments made by this title will be
dedicated toward expediting the process for the review of device
applications and for assuring the safety and effectiveness of devices,
as set forth in the goals identified for purposes of part 3 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
in the letters from the Secretary of Health and Human Services to the
Chairman of the Committee on Health, Education, Labor, and Pensions of
the Senate and the Chairman of the Committee on Energy and Commerce of
the House of Representatives, as set forth in the Congressional Record.
SEC. 202. DEFINITIONS.
Section 737 (21 U.S.C. 379i) is amended--
(1) in paragraph (9), by striking ``incurred'' after
``expenses'';
(2) in paragraph (10), by striking ``October 2001'' and
inserting ``October 2011''; and
(3) in paragraph (13), by striking ``is required to
register'' and all that follows through the end of paragraph
(13) and inserting the following: ``is registered (or is
required to register) with the Secretary under section 510
because such establishment is engaged in the manufacture,
preparation, propagation, compounding, or processing of a
device.''.
SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.
(a) Types of Fees.--Section 738(a) (21 U.S.C. 379j(a)) is amended--
(1) in paragraph (1), by striking ``fiscal year 2008'' and
inserting ``fiscal year 2013'';
[[Page 1003]]
(2) in paragraph (2)(A)--
(A) in the matter preceding clause (i)--
(i) by striking ``subsections (d) and (e)''
and inserting ``subsections (d), (e), and (f)'';
(ii) by striking ``October 1, 2002'' and
inserting ``October 1, 2012''; and
(iii) by striking ``subsection (c)(1)'' and
inserting ``subsection (c)''; and
(B) in clause (viii), by striking ``1.84'' and
inserting ``2''; and
(3) in paragraph (3)--
(A) in subparagraph (A), by inserting ``and
subsection (f)'' after ``subparagraph (B)''; and
(B) in subparagraph (C), by striking ``initial
registration'' and all that follows through ``section
510.'' and inserting ``later of--
``(i) the initial or annual registration (as
applicable) of the establishment under section
510; or
``(ii) the first business day after the date
of enactment of an appropriations Act providing
for the collection and obligation of fees for such
year under this section.''.
(b) Fee Amounts.--Section 738(b) (21 U.S.C. 379j(b)) is amended to
read as follows:
``(b) Fee Amounts.--
``(1) In general.--Subject to subsections (c), (d), (e),
(f), and (i), for each of fiscal years 2013 through 2017, fees
under subsection (a) shall be derived from the base fee amounts
specified in paragraph (2), to generate the total revenue
amounts specified in paragraph (3).
``(2) Base fee amounts specified.--For purposes of paragraph
(1), the base fee amounts specified in this paragraph are as
follows:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
``Fee Type Year 2013 Year 2014 Year 2015 Year 2016 Year 2017
----------------------------------------------------------------------------------------------------------------
Premarket Application.................................... $248,000 $252,960 $258,019 $263,180 $268,443
Establishment Registration............................... $2,575 $3,200 $3,750 $3,872 $3,872
----------------------------------------------------------------------------------------------------------------
``(3) Total revenue amounts specified.--For purposes of
paragraph (1), the total revenue amounts specified in this
paragraph are as follows:
``(A) $97,722,301 for fiscal year 2013.
``(B) $112,580,497 for fiscal year 2014.
``(C) $125,767,107 for fiscal year 2015.
``(D) $129,339,949 for fiscal year 2016.
``(E) $130,184,348 for fiscal year 2017.''.
(c) Annual Fee Setting; Adjustments.--Section 738(c) (21 U.S.C.
379j(c)) is amended--
(1) in the subsection heading, by inserting ``;
Adjustments'' after ``Setting'';
(2) by striking paragraphs (1) and (2);
(3) by redesignating paragraphs (3) and (4) as paragraphs
(4) and (5), respectively; and
[[Page 1004]]
(4) by inserting before paragraph (4), as so redesignated,
the following:
``(1) In general.-- <> The Secretary shall, 60 days before the start of
each fiscal year after September 30, 2012, establish fees under
subsection (a), based on amounts specified under subsection (b)
and the adjustments provided under this subsection, and publish
such fees, and the rationale for any adjustments to such fees,
in the Federal Register.
``(2) Inflation adjustments.--
``(A) Adjustment to total revenue amounts.--For
fiscal year 2014 and each subsequent fiscal year, the
Secretary shall adjust the total revenue amount
specified in subsection (b)(3) for such fiscal year by
multiplying such amount by the applicable inflation
adjustment under subparagraph (B) for such year.
``(B) Applicable inflation adjustment to total
revenue amounts.--The applicable inflation adjustment
for a fiscal year is--
``(i) for fiscal year 2014, the base inflation
adjustment under subparagraph (C) for such fiscal
year; and
``(ii) for fiscal year 2015 and each
subsequent fiscal year, the product of--
``(I) the base inflation adjustment
under subparagraph (C) for such fiscal
year; and
``(II) the product of the base
inflation adjustment under subparagraph
(C) for each of the fiscal years
preceding such fiscal year, beginning
with fiscal year 2014.
``(C) Base inflation adjustment to total revenue
amounts.--
``(i) In general.--Subject to further
adjustment under clause (ii), the base inflation
adjustment for a fiscal year is the sum of one
plus--
``(I) the average annual percent
change in the cost, per full-time
equivalent position of the Food and Drug
Administration, of all personnel
compensation and benefits paid with
respect to such positions for the first
3 years of the preceding 4 fiscal years,
multiplied by 0.60; and
``(II) the average annual percent
change that occurred in the Consumer
Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not
Seasonally Adjusted; All items; Annual
Index) for the first 3 years of the
preceding 4 years of available data
multiplied by 0.40.
``(ii) Limitations.--For purposes of
subparagraph (B), if the base inflation adjustment
for a fiscal year under clause (i)--
``(I) is less than 1, such
adjustment shall be considered to be
equal to 1; or
``(II) is greater than 1.04, such
adjustment shall be considered to be
equal to 1.04.
``(D) Adjustment to base fee amounts.--For each of
fiscal years 2014 through 2017, the base fee amounts
specified in subsection (b)(2) shall be adjusted as
needed, on a uniform proportionate basis, to generate
the total
[[Page 1005]]
revenue amounts under subsection (b)(3), as adjusted for
inflation under subparagraph (A).
``(3) Volume-based adjustments to establishment registration
base fees.--For each of fiscal years 2014 through 2017, after
the base fee amounts specified in subsection (b)(2) are adjusted
under paragraph (2)(D), the base establishment registration fee
amounts specified in such subsection shall be further adjusted,
as the Secretary estimates is necessary in order for total fee
collections for such fiscal year to generate the total revenue
amounts, as adjusted under paragraph (2).''.
(d) Fee Waiver or Reduction.--Section 738 (21 U.S.C. 379j) is
amended by--
(1) redesignating subsections (f) through (k) as subsections
(g) through (l), respectively; and
(2) by inserting after subsection (e) the following new
subsection:
``(f) Fee Waiver or Reduction.--
``(1) In general.--The Secretary may, at the Secretary's
sole discretion, grant a waiver or reduction of fees under
subsection (a)(2) or (a)(3) if the Secretary finds that such
waiver or reduction is in the interest of public health.
``(2) Limitation.--The sum of all fee waivers or reductions
granted by the Secretary in any fiscal year under paragraph (1)
shall not exceed 2 percent of the total fee revenue amounts
established for such year under subsection (c).
``(3) Duration.--The authority provided by this subsection
terminates October 1, 2017.''.
(e) Conditions.--Section 738(h)(1)(A) (21 U.S.C. 379j(h)(1)(A)), as
redesignated by subsection (d)(1), is amended by striking
``$205,720,000'' and inserting ``$280,587,000''.
(f) Crediting and Availability of Fees.--Section 738(i) (21 U.S.C.
379j(i)), as redesignated by subsection (d)(1), is amended--
(1) in paragraph (1), by striking ``Fees authorized'' and
inserting ``Subject to paragraph (2)(C), fees authorized'';
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) in clause (i), by striking ``shall be
retained'' and inserting ``subject to subparagraph
(C), shall be collected and available''; and
(ii) in clause (ii)--
(I) by striking ``collected and''
after ``shall only be''; and
(II) by striking ``fiscal year
2002'' and inserting ``fiscal year
2009''; and
(B) by adding at the end, the following:
``(C) Provision for early payments.--Payment of fees
authorized under this section for a fiscal year, prior
to the due date for such fees, may be accepted by the
Secretary in accordance with authority provided in
advance in a prior year appropriations Act.'';
(3) by amending paragraph (3) to read as follows:
``(3) Authorizations of appropriations.--For each of the
fiscal years 2013 through 2017, there is authorized to be
appropriated for fees under this section an amount equal to the
total revenue amount specified under subsection (b)(3) for the
fiscal year, as adjusted under subsection (c) and, for fiscal
[[Page 1006]]
year 2017 only, as further adjusted under paragraph (4).''; and
(4) in paragraph (4)--
(A) by striking ``fiscal years 2008, 2009, and
2010'' and inserting ``fiscal years 2013, 2014, and
2015'';
(B) by striking ``fiscal year 2011'' and inserting
``fiscal year 2016'';
(C) by striking ``June 30, 2011'' and inserting
``June 30, 2016'';
(D) by striking ``the amount of fees specified in
aggregate in'' and inserting ``the cumulative amount
appropriated pursuant to'';
(E) by striking ``aggregate amount in'' before
``excess shall be credited''; and
(F) by striking ``fiscal year 2012'' and inserting
``fiscal year 2017''.
(g) Conforming Amendment.--Section 515(c)(4)(A) (21 U.S.C.
360e(c)(4)(A)) is amended by striking ``738(g)'' and inserting
``738(h)''.
SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Reauthorization.--Section 738A(b) (21 U.S.C. 379j-1(b)) is
amended--
(1) in paragraph (1), by striking ``2012'' and inserting
``2017''; and
(2) in paragraph (5), by striking ``2012'' and inserting
``2017''.
(b) Performance Reports.--Section 738A(a) (21 U.S.C. 379j-1(a)) is
amended--
(1) by striking paragraph (1) and inserting the following:
``(1) Performance report.--
``(A) In general.-- <> Beginning with fiscal year 2013, for each fiscal
year for which fees are collected under this part, the
Secretary shall prepare and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of
Representatives annual reports concerning the progress
of the Food and Drug Administration in achieving the
goals identified in the letters described in section
201(b) of the Medical Device User Fee Amendments of 2012
during such fiscal year and the future plans of the Food
and Drug Administration for meeting the goals.
``(B) Publication.-- <> With regard to information to be
reported by the Food and Drug Administration to industry
on a quarterly and annual basis pursuant to the letters
described in section 201(b) of the Medical Device User
Fee Amendments Act of 2012, the Secretary shall make
such information publicly available on the Internet Web
site of the Food and Drug Administration not later than
60 days after the end of each quarter or 120 days after
the end of each fiscal year, respectively, to which such
information applies. This information shall include the
status of the independent assessment identified in the
letters described in such section 201(b).
``(C) Updates.--The Secretary shall include in each
report under subparagraph (A) information on all
previous cohorts for which the Secretary has not given a
complete response on all device premarket applications
and reports,
[[Page 1007]]
supplements, and premarket notifications in the
cohort.''; and
(2) in paragraph (2), by striking ``2008 through 2012'' and
inserting ``2013 through 2017''.
SEC. 205. <> SAVINGS CLAUSE.
<> Notwithstanding the amendments
made by this title, part 3 of subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on
the day before the date of the enactment of this title, shall continue
to be in effect with respect to the submissions listed in section
738(a)(2)(A) of such Act (in effect as of such day) that on or after
October 1, 2007, but before October 1, 2012, were accepted by the Food
and Drug Administration for filing with respect to assessing and
collecting any fee required by such part for a fiscal year prior to
fiscal year 2013.
SEC. 206. <> EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2012, or the date of the enactment of this Act, whichever is later,
except that fees under part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all
submissions listed in section 738(a)(2)(A) of such Act received on or
after October 1, 2012, regardless of the date of the enactment of this
Act.
SEC. 207. SUNSET CLAUSE.
(a) In General.-- <> Sections 737 and 738
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall
cease to be effective October 1, 2017. Section 738A (21 U.S.C. 739j-1)
of the Federal Food, Drug, and Cosmetic Act (regarding reauthorization
and reporting requirements) shall cease to be effective January 31,
2018.
(b) Previous Sunset Provision.--
(1) In general.-- <> Section 217 of the Food
and Drug Administration Amendments Act of 2007 (Title II of
Public Law 110-85) <> is repealed.
(2) Conforming amendment.--The Food and Drug Administration
Amendments Act of 2007 (Public Law 110-85) is amended in the
table of contents in section 2, <> by
striking the item relating to section 217.
(c) Technical Clarification.-- <> Effective September
30, 2007--
(1) section 107 of the Medical Device User Fee and
Modernization Act of 2002 (Public Law 107-250) <> is repealed; and
(2) the table of contents in section 1(b) of such Act is
amended by striking the item related to section 107.
SEC. 208. STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES
RELATED TO THE PROCESS FOR THE REVIEW OF
DEVICE APPLICATIONS.
Subchapter A of chapter VII (21 U.S.C. 371 et seq.) is amended by
inserting after section 713 the following new section:
``SEC. 714. <> STREAMLINED HIRING AUTHORITY.
``(a) In General.--In addition to any other personnel authorities
under other provisions of law, the Secretary may, without regard to the
provisions of title 5, United States Code, governing
[[Page 1008]]
appointments in the competitive service, appoint employees to positions
in the Food and Drug Administration to perform, administer, or support
activities described in subsection (b), if the Secretary determines that
such appointments are needed to achieve the objectives specified in
subsection (c).
``(b) Activities Described.--The activities described in this
subsection are activities under this Act related to the process for the
review of device applications (as defined in section 737(8)).
``(c) Objectives Specified.--The objectives specified in this
subsection are with respect to the activities under subsection (b), the
goals referred to in section 738A(a)(1).
``(d) Internal Controls.--The Secretary shall institute appropriate
internal controls for appointments under this section.
``(e) Sunset.--The authority to appoint employees under this section
shall terminate on the date that is 3 years after the date of enactment
of this section.''.
TITLE III-- <> FEES
RELATING TO GENERIC DRUGS
SEC. 301. SHORT TITLE.
(a) Short Title.-- <> This title may be
cited as the ``Generic Drug User Fee Amendments of 2012''.
(b) Finding.-- <> The Congress finds
that the fees authorized by the amendments made in this title will be
dedicated to human generic drug activities, as set forth in the goals
identified for purposes of part 7 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary
of Health and Human Services to the Chairman of the Committee on Health,
Education, Labor, and Pensions of the Senate and the Chairman of the
Committee on Energy and Commerce of the House of Representatives, as set
forth in the Congressional Record.
SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.
Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by
adding at the end the following:
``PART 7--FEES RELATING TO GENERIC DRUGS
``SEC. 744A. <> DEFINITIONS.
``For purposes of this part:
``(1) The term `abbreviated new drug application'--
``(A) means an application submitted under section
505(j), an abbreviated application submitted under
section 507 (as in effect on the day before the date of
enactment of the Food and Drug Administration
Modernization Act of 1997), or an abbreviated new drug
application submitted pursuant to regulations in effect
prior to the implementation of the Drug Price
Competition and Patent Term Restoration Act of 1984; and
``(B) does not include an application for a positron
emission tomography drug.
``(2) The term `active pharmaceutical ingredient' means--
``(A) a substance, or a mixture when the substance
is unstable or cannot be transported on its own,
intended--
[[Page 1009]]
``(i) to be used as a component of a drug; and
``(ii) to furnish pharmacological activity or
other direct effect in the diagnosis, cure,
mitigation, treatment, or prevention of disease,
or to affect the structure or any function of the
human body; or
``(B) a substance intended for final
crystallization, purification, or salt formation, or any
combination of those activities, to become a substance
or mixture described in subparagraph (A).
``(3) The term `adjustment factor' means a factor applicable
to a fiscal year that is the Consumer Price Index for all urban
consumers (all items; United States city average) for October of
the preceding fiscal year divided by such Index for October
2011.
``(4) The term `affiliate' means a business entity that has
a relationship with a second business entity if, directly or
indirectly--
``(A) one business entity controls, or has the power
to control, the other business entity; or
``(B) a third party controls, or has power to
control, both of the business entities.
``(5)(A) The term `facility'--
``(i) means a business or other entity--
``(I) under one management, either direct or
indirect; and
``(II) at one geographic location or address
engaged in manufacturing or processing an active
pharmaceutical ingredient or a finished dosage
form; and
``(ii) does not include a business or other entity
whose only manufacturing or processing activities are
one or more of the following: repackaging, relabeling,
or testing.
``(B) For purposes of subparagraph (A), separate buildings
within close proximity are considered to be at one geographic
location or address if the activities in them are--
``(i) closely related to the same business
enterprise;
``(ii) under the supervision of the same local
management; and
``(iii) capable of being inspected by the Food and
Drug Administration during a single inspection.
``(C) If a business or other entity would meet the
definition of a facility under this paragraph but for being
under multiple management, the business or other entity is
deemed to constitute multiple facilities, one per management
entity, for purposes of this paragraph.
``(6) The term `finished dosage form' means--
``(A) a drug product in the form in which it will be
administered to a patient, such as a tablet, capsule,
solution, or topical application;
``(B) a drug product in a form in which
reconstitution is necessary prior to administration to a
patient, such as oral suspensions or lyophilized
powders; or
``(C) any combination of an active pharmaceutical
ingredient with another component of a drug product for
purposes of production of a drug product described in
subparagraph (A) or (B).
``(7) The term `generic drug submission' means an
abbreviated new drug application, an amendment to an abbreviated
[[Page 1010]]
new drug application, or a prior approval supplement to an
abbreviated new drug application.
``(8) The term `human generic drug activities' means the
following activities of the Secretary associated with generic
drugs and inspection of facilities associated with generic
drugs:
``(A) The activities necessary for the review of
generic drug submissions, including review of drug
master files referenced in such submissions.
``(B) The issuance of--
``(i) approval letters which approve
abbreviated new drug applications or supplements
to such applications; or
``(ii) complete response letters which set
forth in detail the specific deficiencies in such
applications and, where appropriate, the actions
necessary to place such applications in condition
for approval.
``(C) The issuance of letters related to Type II
active pharmaceutical drug master files which--
``(i) set forth in detail the specific
deficiencies in such submissions, and where
appropriate, the actions necessary to resolve
those deficiencies; or
``(ii) document that no deficiencies need to
be addressed.
``(D) Inspections related to generic drugs.
``(E) Monitoring of research conducted in connection
with the review of generic drug submissions and drug
master files.
``(F) Postmarket safety activities with respect to
drugs approved under abbreviated new drug applications
or supplements, including the following activities:
``(i) Collecting, developing, and reviewing
safety information on approved drugs, including
adverse event reports.
``(ii) Developing and using improved adverse-
event data-collection systems, including
information technology systems.
``(iii) Developing and using improved
analytical tools to assess potential safety
problems, including access to external data bases.
``(iv) Implementing and enforcing section
505(o) (relating to postapproval studies and
clinical trials and labeling changes) and section
505(p) (relating to risk evaluation and mitigation
strategies) insofar as those activities relate to
abbreviated new drug applications.
``(v) Carrying out section 505(k)(5) (relating
to adverse-event reports and postmarket safety
activities).
``(G) Regulatory science activities related to
generic drugs.
``(9) The term `positron emission tomography drug' has the
meaning given to the term `compounded positron emission
tomography drug' in section 201(ii), except that paragraph
(1)(B) of such section shall not apply.
``(10) The term `prior approval supplement' means a request
to the Secretary to approve a change in the drug substance, drug
product, production process, quality controls, equipment, or
facilities covered by an approved abbreviated new drug
application when that change has a substantial potential to
[[Page 1011]]
have an adverse effect on the identity, strength, quality,
purity, or potency of the drug product as these factors may
relate to the safety or effectiveness of the drug product.
``(11) The term `resources allocated for human generic drug
activities' means the expenses for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related
to such officers and employees and to contracts with
such contractors;
``(B) management of information, and the
acquisition, maintenance, and repair of computer
resources;
``(C) leasing, maintenance, renovation, and repair
of facilities and acquisition, maintenance, and repair
of fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(D) collecting fees under subsection (a) and
accounting for resources allocated for the review of
abbreviated new drug applications and supplements and
inspection related to generic drugs.
``(12) The term `Type II active pharmaceutical ingredient
drug master file' means a submission of information to the
Secretary by a person that intends to authorize the Food and
Drug Administration to reference the information to support
approval of a generic drug submission without the submitter
having to disclose the information to the generic drug
submission applicant.
``SEC. 744B. <> AUTHORITY TO ASSESS AND USE
HUMAN GENERIC DRUG FEES.
``(a) Types of Fees.-- <> Beginning in fiscal
year 2013, the Secretary shall assess and collect fees in accordance
with this section as follows:
``(1) One-time backlog fee for abbreviated new drug
applications pending on october 1, 2012.--
``(A) In general.--Each person that owns an
abbreviated new drug application that is pending on
October 1, 2012, and that has not received a tentative
approval prior to that date, shall be subject to a fee
for each such application, as calculated under
subparagraph (B).
``(B) Method of fee amount calculation.--The amount
of each one-time backlog fee shall be calculated by
dividing $50,000,000 by the total number of abbreviated
new drug applications pending on October 1, 2012, that
have not received a tentative approval as of that date.
``(C) Notice.-- <> Not later than October 31, 2012, the
Secretary shall publish in the Federal Register a notice
announcing the amount of the fee required by
subparagraph (A).
``(D) Fee due date.--The fee required by
subparagraph (A) shall be due no later than 30 calendar
days after the date of the publication of the notice
specified in subparagraph (C).
``(2) Drug master file fee.--
``(A) In general.--Each person that owns a Type II
active pharmaceutical ingredient drug master file that
is referenced on or after October 1, 2012, in a generic
drug
[[Page 1012]]
submission by any initial letter of authorization shall
be subject to a drug master file fee.
``(B) One-time payment.--If a person has paid a drug
master file fee for a Type II active pharmaceutical
ingredient drug master file, the person shall not be
required to pay a subsequent drug master file fee when
that Type II active pharmaceutical ingredient drug
master file is subsequently referenced in generic drug
submissions.
``(C) Notice.-- <>
``(i) Fiscal year 2013.--Not later than
October 31, 2012, the Secretary shall publish in
the Federal Register a notice announcing the
amount of the drug master file fee for fiscal year
2013.
``(ii) Fiscal year 2014 through 2017.--Not
later than 60 days before the start of each of
fiscal years 2014 through 2017, the Secretary
shall publish in the Federal Register the amount
of the drug master file fee established by this
paragraph for such fiscal year.
``(D) Availability for reference.--
``(i) In general.--Subject to subsection
(g)(2)(C), for a generic drug submission to
reference a Type II active pharmaceutical
ingredient drug master file, the drug master file
must be deemed available for reference by the
Secretary.
``(ii) Conditions.--
<> A drug
master file shall be deemed available for
reference by the Secretary if--
``(I) the person that owns a Type II
active pharmaceutical ingredient drug
master file has paid the fee required
under subparagraph (A) within 20
calendar days after the applicable due
date under subparagraph (E); and
``(II) the drug master file has not
failed an initial completeness
assessment by the Secretary, in
accordance with criteria to be published
by the Secretary.
``(iii) List.-- <> The Secretary shall
make publicly available on the Internet Web site
of the Food and Drug Administration a list of the
drug master file numbers that correspond to drug
master files that have successfully undergone an
initial completeness assessment, in accordance
with criteria to be published by the Secretary,
and are available for reference.
``(E) Fee due date.--
``(i) In general.--Subject to clause (ii), a
drug master file fee shall be due no later than
the date on which the first generic drug
submission is submitted that references the
associated Type II active pharmaceutical
ingredient drug master file.
``(ii) Limitation.--No fee shall be due under
subparagraph (A) for a fiscal year until the later
of--
``(I) 30 calendar days after
publication of the notice provided for
in clause (i) or (ii) of subparagraph
(C), as applicable; or
``(II) 30 calendar days after the
date of enactment of an appropriations
Act providing for the collection and
obligation of fees under this section.
[[Page 1013]]
``(3) Abbreviated new drug application and prior approval
supplement filing fee.--
``(A) In general.--Each applicant that submits, on
or after October 1, 2012, an abbreviated new drug
application or a prior approval supplement to an
abbreviated new drug application shall be subject to a
fee for each such submission in the amount established
under subsection (d).
``(B) Notice.-- <>
``(i) Fiscal year 2013.--Not later than
October 31, 2012, the Secretary shall publish in
the Federal Register a notice announcing the
amount of the fees under subparagraph (A) for
fiscal year 2013.
``(ii) Fiscal years 2014 through 2017.--Not
later than 60 days before the start of each of
fiscal years 2014 through 2017, the Secretary
shall publish in the Federal Register the amount
of the fees under subparagraph (A) for such fiscal
year.
``(C) Fee due date.--
``(i) In general.--Except as provided in
clause (ii), the fees required by subparagraphs
(A) and (F) shall be due no later than the date of
submission of the abbreviated new drug application
or prior approval supplement for which such fee
applies.
``(ii) Special rule for 2013.--For fiscal year
2013, such fees shall be due on the later of--
``(I) the date on which the fee is
due under clause (i);
``(II) 30 calendar days after
publication of the notice referred to in
subparagraph (B)(i); or
``(III) if an appropriations Act is
not enacted providing for the collection
and obligation of fees under this
section by the date of submission of the
application or prior approval supplement
for which the fees under subparagraphs
(A) and (F) apply, 30 calendar days
after the date that such an
appropriations Act is enacted.
``(D) Refund of fee if abbreviated new drug
application is not considered to have been received.--
The Secretary shall refund 75 percent of the fee paid
under subparagraph (A) for any abbreviated new drug
application or prior approval supplement to an
abbreviated new drug application that the Secretary
considers not to have been received within the meaning
of section 505(j)(5)(A) for a cause other than failure
to pay fees.
``(E) Fee for an application the secretary considers
not to have been received, or that has been withdrawn.--
An abbreviated new drug application or prior approval
supplement that was submitted on or after October 1,
2012, and that the Secretary considers not to have been
received, or that has been withdrawn, shall, upon
resubmission of the application or a subsequent new
submission following the applicant's withdrawal of the
application, be subject to a full fee under subparagraph
(A).
``(F) Additional fee for active pharmaceutical
ingredient information not included by reference to
[[Page 1014]]
type ii active pharmaceutical ingredient drug master
file.--An applicant that submits a generic drug
submission on or after October 1, 2012, shall pay a fee,
in the amount determined under subsection (d)(3), in
addition to the fee required under subparagraph (A),
if--
``(i) such submission contains information
concerning the manufacture of an active
pharmaceutical ingredient at a facility by means
other than reference by a letter of authorization
to a Type II active pharmaceutical drug master
file; and
``(ii) a fee in the amount equal to the drug
master file fee established in paragraph (2) has
not been previously paid with respect to such
information.
``(4) Generic drug facility fee and active pharmaceutical
ingredient facility fee.--
``(A) In general.--Facilities identified, or
intended to be identified, in at least one generic drug
submission that is pending or approved to produce a
finished dosage form of a human generic drug or an
active pharmaceutical ingredient contained in a human
generic drug shall be subject to fees as follows:
``(i) Generic drug facility.--Each person that
owns a facility which is identified or intended to
be identified in at least one generic drug
submission that is pending or approved to produce
one or more finished dosage forms of a human
generic drug shall be assessed an annual fee for
each such facility.
``(ii) Active pharmaceutical ingredient
facility.--Each person that owns a facility which
produces, or which is pending review to produce,
one or more active pharmaceutical ingredients
identified, or intended to be identified, in at
least one generic drug submission that is pending
or approved or in a Type II active pharmaceutical
ingredient drug master file referenced in such a
generic drug submission, shall be assessed an
annual fee for each such facility.
``(iii) Facilities producing both active
pharmaceutical ingredients and finished dosage
forms.--Each person that owns a facility
identified, or intended to be identified, in at
least one generic drug submission that is pending
or approved to produce both one or more finished
dosage forms subject to clause (i) and one or more
active pharmaceutical ingredients subject to
clause (ii) shall be subject to fees under both
such clauses for that facility.
``(B) Amount.--The amount of fees established under
subparagraph (A) shall be established under subsection
(d).
``(C) Notice.-- <>
``(i) Fiscal year 2013.--For fiscal year 2013,
the Secretary shall publish in the Federal
Register a notice announcing the amount of the
fees provided for in subparagraph (A) within the
timeframe specified in subsection (d)(1)(B).
``(ii) Fiscal years 2014 through 2017.--Within
the timeframe specified in subsection (d)(2), the
Secretary
[[Page 1015]]
shall publish in the Federal Register the amount
of the fees under subparagraph (A) for such fiscal
year.
``(D) Fee due date.--
``(i) Fiscal year 2013.--For fiscal year 2013,
the fees under subparagraph (A) shall be due on
the later of--
``(I) not later than 45 days after
the publication of the notice under
subparagraph (B); or
``(II) if an appropriations Act is
not enacted providing for the collection
and obligation of fees under this
section by the date of the publication
of such notice, 30 days after the date
that such an appropriations Act is
enacted.
``(ii) Fiscal years 2014 through 2017.--For
each of fiscal years 2014 through 2017, the fees
under subparagraph (A) for such fiscal year shall
be due on the later of--
``(I) the first business day on or
after October 1 of each such year; or
``(II) the first business day after
the enactment of an appropriations Act
providing for the collection and
obligation of fees under this section
for such year.
``(5) Date of submission.--For purposes of this Act, a
generic drug submission or Type II pharmaceutical master file is
deemed to be `submitted' to the Food and Drug Administration--
``(A) if it is submitted via a Food and Drug
Administration electronic gateway, on the day when
transmission to that electronic gateway is completed,
except that a submission or master file that arrives on
a weekend, Federal holiday, or day when the Food and
Drug Administration office that will review that
submission is not otherwise open for business shall be
deemed to be submitted on the next day when that office
is open for business; or
``(B) if it is submitted in physical media form, on
the day it arrives at the appropriate designated
document room of the Food and Drug Administration.
``(b) Fee Revenue Amounts.--
``(1) In general.--
``(A) Fiscal year 2013.--For fiscal year 2013, fees
under subsection (a) shall be established to generate a
total estimated revenue amount under such subsection of
$299,000,000. Of that amount--
``(i) $50,000,000 shall be generated by the
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 pursuant to subsection (c).
[[Page 1016]]
``(2) Types of fees.--In establishing fees under paragraph
(1) to generate the revenue amounts specified in paragraph
(1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each of
fiscal years 2014 through 2017, such fees shall be derived from
the fees under paragraphs (2) through (4) of subsection (a) as
follows:
``(A) Six percent shall be derived from fees under
subsection (a)(2) (relating to drug master files).
``(B) Twenty-four percent shall be derived from fees
under subsection (a)(3) (relating to abbreviated new
drug applications and supplements). The amount of a fee
for a prior approval supplement shall be half the amount
of the fee for an abbreviated new drug application.
``(C) Fifty-six percent shall be derived from fees
under subsection (a)(4)(A)(i) (relating to generic drug
facilities). The amount of the fee for a facility
located outside the United States and its territories
and possessions shall be not less than $15,000 and not
more than $30,000 higher than the amount of the fee for
a facility located in the United States and its
territories and possessions, as determined by the
Secretary on the basis of data concerning the difference
in cost between inspections of facilities located in the
United States, including its territories and
possessions, and those located outside of the United
States and its territories and possessions.
``(D) Fourteen percent shall be derived from fees
under subsection (a)(4)(A)(ii) (relating to active
pharmaceutical ingredient facilities). The amount of the
fee for a facility located outside the United States and
its territories and possessions shall be not less than
$15,000 and not more than $30,000 higher than the amount
of the fee for a facility located in the United States,
including its territories and possessions, as determined
by the Secretary on the basis of data concerning the
difference in cost between inspections of facilities
located in the United States and its territories and
possessions and those located outside of the United
States and its territories and possessions.
``(c) Adjustments.--
``(1) Inflation adjustment.-- <> For fiscal year 2014 and subsequent
fiscal years, the revenues established in subsection (b) shall
be adjusted by the Secretary by notice, published in the Federal
Register, for a fiscal year, by an amount equal to the sum of--
``(A) one;
``(B) the average annual percent change in the cost,
per full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and
benefits paid with respect to such positions for the
first 3 years of the preceding 4 fiscal years multiplied
by the proportion of personnel compensation and benefits
costs to total costs of human generic drug activities
for the first 3 years of the preceding 4 fiscal years;
and
``(C) the average annual percent change that
occurred in the Consumer Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not Seasonally
Adjusted; All items; Annual Index) for the first 3 years
of the preceding 4 years of available data multiplied by
[[Page 1017]]
the proportion of all costs other than personnel
compensation and benefits costs to total costs of human
generic drug activities for the first 3 years of the
preceding 4 fiscal years.
The adjustment made each fiscal year under this subsection shall
be added on a compounded basis to the sum of all adjustments
made each fiscal year after fiscal year 2013 under this
subsection.
``(2) Final year adjustment.--For fiscal year 2017, the
Secretary may, in addition to adjustments under paragraph (1),
further increase the fee revenues and fees established in
subsection (b) if such an adjustment is necessary to provide for
not more than 3 months of operating reserves of carryover user
fees for human generic drug activities for the first 3 months of
fiscal year 2018. Such fees may only be used in fiscal year
2018. If such an adjustment is necessary, the rationale for the
amount of the increase shall be contained in the annual notice
establishing fee revenues and fees for fiscal year 2017. If the
Secretary has carryover balances for such activities in excess
of 3 months of such operating reserves, the adjustment under
this subparagraph shall not be made.
``(d) Annual Fee Setting.--
``(1) Fiscal year 2013.-- <> For fiscal
year 2013--
``(A) the Secretary shall establish, by October 31,
2012, the one-time generic drug backlog fee for generic
drug applications pending on October 1, 2012, the drug
master file fee, the abbreviated new drug application
fee, and the prior approval supplement fee under
subsection (a), based on the revenue amounts established
under subsection (b); and
``(B) the Secretary shall establish, not later than
45 days after the date to comply with the requirement
for identification of facilities in subsection (f)(2),
the generic drug facility fee and active pharmaceutical
ingredient facility fee under subsection (a) based on
the revenue amounts established under subsection (b).
``(2) Fiscal years 2014 through 2017.-- <> Not more than 60 days before the first day of each of
fiscal years 2014 through 2017, the Secretary shall establish
the drug master file fee, the abbreviated new drug application
fee, the prior approval supplement fee, the generic drug
facility fee, and the active pharmaceutical ingredient facility
fee under subsection (a) for such fiscal year, based on the
revenue amounts established under subsection (b) and the
adjustments provided under subsection (c).
``(3) Fee for active pharmaceutical ingredient information
not included by reference to type ii active pharmaceutical
ingredient drug master file.--In establishing the fees under
paragraphs (1) and (2), the amount of the fee under subsection
(a)(3)(F) shall be determined by multiplying--
``(A) the sum of--
``(i) the total number of such active
pharmaceutical ingredients in such submission; and
``(ii) for each such ingredient that is
manufactured at more than one such facility, the
total number of such additional facilities; and
[[Page 1018]]
``(B) the amount equal to the drug master file fee
established in subsection (a)(2) for such submission.
``(e) Limit.--The total amount of fees charged, as adjusted under
subsection (c), for a fiscal year may not exceed the total costs for
such fiscal year for the resources allocated for human generic drug
activities.
``(f) Identification of Facilities.--
``(1) <> Publication
of notice; deadline for compliance.--Not later than October 1,
2012, the Secretary shall publish in the Federal Register a
notice requiring each person that owns a facility described in
subsection (a)(4)(A), or a site or organization required to be
identified by paragraph (4), to submit to the Secretary
information on the identity of each such facility, site, or
organization. The notice required by this paragraph shall
specify the type of information to be submitted and the means
and format for submission of such information.
``(2) <> Required submission of facility
identification.--Each person that owns a facility described in
subsection (a)(4)(A) or a site or organization required to be
identified by paragraph (4) shall submit to the Secretary the
information required under this subsection each year. Such
information shall--
``(A) for fiscal year 2013, be submitted not later
than 60 days after the publication of the notice under
paragraph (1); and
``(B) for each subsequent fiscal year, be submitted,
updated, or reconfirmed on or before June 1 of the
previous year.
``(3) Contents of notice.--At a minimum, the submission
required by paragraph (2) shall include for each such facility--
``(A) identification of a facility identified or
intended to be identified in an approved or pending
generic drug submission;
``(B) whether the facility manufactures active
pharmaceutical ingredients or finished dosage forms, or
both;
``(C) whether or not the facility is located within
the United States and its territories and possessions;
``(D) whether the facility manufactures positron
emission tomography drugs solely, or in addition to
other drugs; and
``(E) whether the facility manufactures drugs that
are not generic drugs.
``(4) Certain sites and organizations.--
``(A) In general.--Any person that owns or operates
a site or organization described in subparagraph (B)
shall submit to the Secretary information concerning the
ownership, name, and address of the site or
organization.
``(B) Sites and organizations.--A site or
organization is described in this subparagraph if it is
identified in a generic drug submission and is--
``(i) a site in which a bioanalytical study is
conducted;
``(ii) a clinical research organization;
``(iii) a contract analytical testing site; or
``(iv) a contract repackager site.
``(C) Notice.-- <> The Secretary may, by notice published in
the Federal Register, specify the means and format
[[Page 1019]]
for submission of the information under subparagraph (A)
and may specify, as necessary for purposes of this
section, any additional information to be submitted.
``(D) Inspection authority.--The Secretary's
inspection authority under section 704(a)(1) shall
extend to all such sites and organizations.
``(g) Effect of Failure To Pay Fees.-- <>
``(1) Generic drug backlog fee.-- <> Failure to pay the fee under subsection (a)(1)
shall result in the Secretary placing the person that owns the
abbreviated new drug application subject to that fee on a
publicly available arrears list, such that no new abbreviated
new drug applications or supplement submitted on or after
October 1, 2012, from that person, or any affiliate of that
person, will be received within the meaning of section
505(j)(5)(A) until such outstanding fee is paid.
``(2) Drug master file fee.--
``(A) Failure to pay the fee under subsection (a)(2)
within 20 calendar days after the applicable due date
under subparagraph (E) of such subsection (as described
in subsection (a)(2)(D)(ii)(I)) shall result in the Type
II active pharmaceutical ingredient drug master file not
being deemed available for reference.
``(B)(i) Any generic drug submission submitted on or
after October 1, 2012, that references, by a letter of
authorization, a Type II active pharmaceutical
ingredient drug master file that has not been deemed
available for reference shall not be received within the
meaning of section 505(j)(5)(A) unless the condition
specified in clause (ii) is met.
``(ii) The condition specified in this clause is
that the fee established under subsection (a)(2) has
been paid within 20 calendar days of the Secretary
providing the notification to the sponsor of the
abbreviated new drug application or supplement of the
failure of the owner of the Type II active
pharmaceutical ingredient drug master file to pay the
drug master file fee as specified in subparagraph (C).
``(C)(i) <> If an abbreviated
new drug application or supplement to an abbreviated new
drug application references a Type II active
pharmaceutical ingredient drug master file for which a
fee under subsection (a)(2)(A) has not been paid by the
applicable date under subsection (a)(2)(E), the
Secretary shall notify the sponsor of the abbreviated
new drug application or supplement of the failure of the
owner of the Type II active pharmaceutical ingredient
drug master file to pay the applicable fee.
``(ii) If such fee is not paid within 20 calendar
days of the Secretary providing the notification, the
abbreviated new drug application or supplement to an
abbreviated new drug application shall not be received
within the meaning of 505(j)(5)(A).
``(3) Abbreviated new drug application fee and prior
approval supplement fee.--Failure to pay a fee under
subparagraph (A) or (F) of subsection (a)(3) within 20 calendar
days of the applicable due date under subparagraph (C) of such
subsection shall result in the abbreviated new drug application
or the prior approval supplement to an abbreviated
[[Page 1020]]
new drug application not being received within the meaning of
section 505(j)(5)(A) until such outstanding fee is paid.
``(4) Generic drug facility fee and active pharmaceutical
ingredient facility fee.--
``(A) In general.--Failure to pay the fee under
subsection (a)(4) within 20 calendar days of the due
date as specified in subparagraph (D) of such subsection
shall result in the following:
``(i) <> The
Secretary shall place the facility on a publicly
available arrears list, such that no new
abbreviated new drug application or supplement
submitted on or after October 1, 2012, from the
person that is responsible for paying such fee, or
any affiliate of that person, will be received
within the meaning of section 505(j)(5)(A).
``(ii) Any new generic drug submission
submitted on or after October 1, 2012, that
references such a facility shall not be received,
within the meaning of section 505(j)(5)(A) if the
outstanding facility fee is not paid within 20
calendar days of the Secretary providing the
notification to the sponsor of the failure of the
owner of the facility to pay the facility fee
under subsection (a)(4)(C).
``(iii) All drugs or active pharmaceutical
ingredients manufactured in such a facility or
containing an ingredient manufactured in such a
facility shall be deemed misbranded under section
502(aa).
``(B) Application of penalties.--The penalties under
this paragraph shall apply until the fee established by
subsection (a)(4) is paid or the facility is removed
from all generic drug submissions that refer to the
facility.
``(C) Nonreceival for nonpayment.--
``(i) Notice.--If an abbreviated new drug
application or supplement to an abbreviated new
drug application submitted on or after October 1,
2012, references a facility for which a facility
fee has not been paid by the applicable date under
subsection (a)(4)(C), the Secretary shall notify
the sponsor of the generic drug submission of the
failure of the owner of the facility to pay the
facility fee.
``(ii) Nonreceival.--If the facility fee is
not paid within 20 calendar days of the Secretary
providing the notification under clause (i), the
abbreviated new drug application or supplement to
an abbreviated new drug application shall not be
received within the meaning of section
505(j)(5)(A).
``(h) Limitations.--
``(1) In general.-- <> Fees under
subsection (a) shall be refunded for a fiscal year beginning
after fiscal year 2012, unless appropriations for salaries and
expenses of the Food and Drug Administration for such fiscal
year (excluding the amount of fees appropriated for such fiscal
year) are equal to or greater than the amount of appropriations
for the salaries and expenses of the Food and Drug
Administration for fiscal year 2009 (excluding the amount of
fees appropriated for such fiscal year) multiplied by the
adjustment factor (as defined in section 744A) applicable to the
fiscal year involved.
[[Page 1021]]
``(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal year and if
at a later date in such fiscal year the Secretary may assess
such fees, the Secretary may assess and collect such fees,
without any modification in the rate, for Type II active
pharmaceutical ingredient drug master files, abbreviated new
drug applications and prior approval supplements, and generic
drug facilities and active pharmaceutical ingredient facilities
at any time in such fiscal year notwithstanding the provisions
of subsection (a) relating to the date fees are to be paid.
``(i) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations
Acts, subject to paragraph (2). Such fees are authorized to
remain available until expended. Such sums as may be necessary
may be transferred from the Food and Drug Administration
salaries and expenses appropriation account without fiscal year
limitation to such appropriation account for salaries and
expenses with such fiscal year limitation. The sums transferred
shall be available solely for human generic drug activities.
``(2) Collections and appropriation acts.--
``(A) In general.--The fees authorized by this
section--
``(i) subject to subparagraphs (C) and (D),
shall be collected and available in each fiscal
year in an amount not to exceed the amount
specified in appropriation Acts, or otherwise made
available for obligation for such fiscal year; and
``(ii) <> shall be
available for a fiscal year beginning after fiscal
year 2012 to defray the costs of human generic
drug activities (including such costs for an
additional number of full-time equivalent
positions in the Department of Health and Human
Services to be engaged in such activities), only
if the Secretary allocates for such purpose an
amount for such fiscal year (excluding amounts
from fees collected under this section) no less
than $97,000,000 multiplied by the adjustment
factor defined in section 744A(3) applicable to
the fiscal year involved.
``(B) Compliance.--The Secretary shall be considered
to have met the requirements of subparagraph (A)(ii) in
any fiscal year if the costs funded by appropriations
and allocated for human generic activities are not more
than 10 percent below the level specified in such
subparagraph.
``(C) Fee collection during first program year.--
Until the date of enactment of an Act making
appropriations through September 30, 2013 for the
salaries and expenses account of the Food and Drug
Administration, fees authorized by this section for
fiscal year 2013, may be collected and shall be credited
to such account and remain available until expended.
``(D) Provision for early payments in subsequent
years.--Payment of fees authorized under this section
for a fiscal year (after fiscal year 2013), prior to the
due date for such fees, may be accepted by the Secretary
in
[[Page 1022]]
accordance with authority provided in advance in a prior
year appropriations Act.
``(3) Authorization of appropriations.--For each of the
fiscal years 2013 through 2017, there is authorized to be
appropriated for fees under this section an amount equivalent to
the total revenue amount determined under subsection (b) for the
fiscal year, as adjusted under subsection (c), if applicable, or
as otherwise affected under paragraph (2) of this subsection.
``(j) Collection of Unpaid Fees.-- <> In any case
where the Secretary does not receive payment of a fee assessed under
subsection (a) within 30 calendar days after it is due, such fee shall
be treated as a claim of the United States Government subject to
subchapter II of chapter 37 of title 31, United States Code.
``(k) Construction.--This section may not be construed to require
that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employees, and advisory
committees not engaged in human generic drug activities, be reduced to
offset the number of officers, employees, and advisory committees so
engaged.
``(l) Positron Emission Tomography Drugs.--
``(1) Exemption from fees.--Submission of an application for
a positron emission tomography drug or active pharmaceutical
ingredient for a positron emission tomography drug shall not
require the payment of any fee under this section. Facilities
that solely produce positron emission tomography drugs shall not
be required to pay a facility fee as established in subsection
(a)(4).
``(2) Identification requirement.--Facilities that produce
positron emission tomography drugs or active pharmaceutical
ingredients of such drugs are required to be identified pursuant
to subsection (f).
``(m) Disputes Concerning Fees.-- <> To qualify for
the return of a fee claimed to have been paid in error under this
section, a person shall submit to the Secretary a written request
justifying such return within 180 calendar days after such fee was paid.
``(n) Substantially Complete Applications.--An abbreviated new drug
application that is not considered to be received within the meaning of
section 505(j)(5)(A) because of failure to pay an applicable fee under
this provision within the time period specified in subsection (g) shall
be deemed not to have been `substantially complete' on the date of its
submission within the meaning of section 505(j)(5)(B)(iv)(II)(cc). An
abbreviated new drug application that is not substantially complete on
the date of its submission solely because of failure to pay an
applicable fee under the preceding sentence shall be deemed
substantially complete and received within the meaning of section
505(j)(5)(A) as of the date such applicable fee is received.''.
SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS.
Part 7 of subchapter C of chapter VII, as added by section 302 of
this Act, is amended by inserting after section 744B the following:
``SEC. 744C. <> REAUTHORIZATION; REPORTING
REQUIREMENTS.
``(a) Performance Report.-- <> Beginning with
fiscal year 2013, not later than 120 days after the end of each fiscal
year for which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of the House
[[Page 1023]]
of Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report concerning the progress of the Food and
Drug Administration in achieving the goals identified in the letters
described in section 301(b) of the Generic Drug User Fee Amendments of
2012 during such fiscal year and the future plans of the Food and Drug
Administration for meeting the goals.
``(b) Fiscal Report.-- <> Beginning with
fiscal year 2013, not later than 120 days after the end of each fiscal
year for which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of the House
of Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report on the implementation of the authority
for such fees during such fiscal year and the use, by the Food and Drug
Administration, of the fees collected for such fiscal year.
``(c) Public Availability.-- <> The Secretary
shall make the reports required under subsections (a) and (b) available
to the public on the Internet Web site of the Food and Drug
Administration.
``(d) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals, and plans for
meeting the goals, for human generic drug activities for the
first 5 fiscal years after fiscal year 2017, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the
House of Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) health care professionals;
``(E) representatives of patient and consumer
advocacy groups; and
``(F) the generic drug industry.
``(2) Prior public input.--Prior to beginning negotiations
with the generic drug industry on the reauthorization of this
part, the Secretary shall--
``(A) <> publish a notice in the Federal Register
requesting public input on the reauthorization;
``(B) hold a public meeting at which the public may
present its views on the reauthorization, including
specific suggestions for changes to the goals referred
to in subsection (a);
``(C) <> provide a period of 30
days after the public meeting to obtain written comments
from the public suggesting changes to this part; and
``(D) <> publish the comments on
the Food and Drug Administration's Internet Web site.
``(3) Periodic consultation.--Not less frequently than once
every month during negotiations with the generic drug industry,
the Secretary shall hold discussions with representatives of
patient and consumer advocacy groups to continue discussions of
their views on the reauthorization and their suggestions for
changes to this part as expressed under paragraph (2).
[[Page 1024]]
``(4) Public review of recommendations.--After negotiations
with the generic drug industry, the Secretary shall--
``(A) present the recommendations developed under
paragraph (1) to the congressional committees specified
in such paragraph;
``(B) <> publish such recommendations in the
Federal Register;
``(C) <> provide for a period of
30 days for the public to provide written comments on
such recommendations;
``(D) hold a meeting at which the public may present
its views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(5) Transmittal of recommendations.--Not later than
January 15, 2017, the Secretary shall transmit to the Congress
the revised recommendations under paragraph (4), a summary of
the views and comments received under such paragraph, and any
changes made to the recommendations in response to such views
and comments.
``(6) Minutes of negotiation meetings.--
``(A) Public availability.-- <> Before presenting the recommendations
developed under paragraphs (1) through (5) to the
Congress, the Secretary shall make publicly available,
on the Internet Web site of the Food and Drug
Administration, minutes of all negotiation meetings
conducted under this subsection between the Food and
Drug Administration and the generic drug industry.
``(B) Content.--The minutes described under
subparagraph (A) shall summarize any substantive
proposal made by any party to the negotiations as well
as significant controversies or differences of opinion
during the negotiations and their resolution.''.
SEC. 304. SUNSET DATES.
(a) Authorization.-- <> Sections 744A
and 744B of the Federal Food, Drug, and Cosmetic Act, as added by
section 302 of this Act, shall cease to be effective October 1, 2017.
(b) Reporting Requirements.-- <> Section
744C of the Federal Food, Drug, and Cosmetic Act, as added by section
303 of this Act, shall cease to be effective January 31, 2018.
SEC. 305. <> EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2012, or the date of the enactment of this title, whichever is later,
except that fees under section 302 shall be assessed for all human
generic drug submissions and Type II active pharmaceutical drug master
files received on or after October 1, 2012, regardless of the date of
enactment of this title.
SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING.
Section 502 (21 U.S.C. 352) is amended by adding at the end the
following:
``(aa) If it is a drug, or an active pharmaceutical ingredient, and
it was manufactured, prepared, propagated, compounded, or processed in a
facility for which fees have not been paid as required by section
744A(a)(4) or for which identifying information required by section
744B(f) has not been submitted, or it contains an active
[[Page 1025]]
pharmaceutical ingredient that was manufactured, prepared, propagated,
compounded, or processed in such a facility.''.
SEC. 307. <> STREAMLINED HIRING AUTHORITY TO
SUPPORT ACTIVITIES RELATED TO HUMAN
GENERIC DRUGS.
Section 714, as added by section 208 of this Act, is amended--
(1) by amending subsection (b) to read as follows:
``(b) Activities Described.--The activities described in this
subsection are--
``(1) activities under this Act related to the process for
the review of device applications (as defined in section
737(8)); and
``(2) activities under this Act related to human generic
drug activities (as defined in section 744A).''; and
(2) by amending subsection (c) to read as follows:
``(c) Objectives Specified.--The objectives specified in this
subsection are--
``(1) with respect to the activities under subsection
(b)(1), the goals referred to in section 738A(a)(1); and
``(2) with respect to the activities under subsection
(b)(2), the goals referred to in section 744C(a).''.
SEC. 308. ADDITIONAL REPORTING REQUIREMENTS.
Subchapter A of chapter VII (21 U.S.C. 371 et seq.), as amended by
section 208, is further amended by adding at the end the following:
``SEC. 715. <> REPORTING REQUIREMENTS.
``(a) Generic Drugs.-- <> Beginning with
fiscal year 2013 and ending after fiscal year 2017, not later than 120
days after the end of each fiscal year for which fees are collected
under part 7 of subchapter C, the Secretary shall prepare and submit to
the Committee on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House of Representatives
a report concerning, for all applications for approval of a generic drug
under section 505(j), amendments to such applications, and prior
approval supplements with respect to such applications filed in the
previous fiscal year--
``(1) the number of such applications that met the goals
identified for purposes of part 7 of subchapter C, in the
letters from the Secretary of Health and Human Services to the
Chairman of the Committee on Health, Education, Labor, and
Pensions of the Senate and the Chairman of the Committee on
Energy and Commerce of the House of Representatives, as set
forth in the Congressional Record;
``(2) the average total time to decision by the Secretary
for applications for approval of a generic drug under section
505(j), amendments to such applications, and prior approval
supplements with respect to such applications filed in the
previous fiscal year, including the number of calendar days
spent during the review by the Food and Drug Administration and
the number of calendar days spent by the sponsor responding to a
complete response letter;
``(3) the total number of applications under section 505(j),
amendments to such applications, and prior approval supplements
with respect to such applications that were pending with the
Secretary for more than 10 months on the date of
[[Page 1026]]
enactment of the Food and Drug Administration Safety and
Innovation Act; and
``(4) the number of applications described in paragraph (3)
on which the Food and Drug Administration took final regulatory
action in the previous fiscal year.''.
TITLE IV-- <> FEES RELATING TO
BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 401. SHORT TITLE; FINDING.
(a) Short Title.-- <> This title may be
cited as the ``Biosimilar User Fee Act of 2012''.
(b) Finding.-- <> The Congress finds
that the fees authorized by the amendments made in this title will be
dedicated to expediting the process for the review of biosimilar
biological product applications, including postmarket safety activities,
as set forth in the goals identified for purposes of part 8 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act,
in the letters from the Secretary of Health and Human Services to the
Chairman of the Committee on Health, Education, Labor, and Pensions of
the Senate and the Chairman of the Committee on Energy and Commerce of
the House of Representatives, as set forth in the Congressional Record.
SEC. 402. FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS.
Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by
inserting after part 7, as added by title III of this Act, the
following:
``PART 8--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
``SEC. 744G. <> DEFINITIONS.
``For purposes of this part:
``(1) The term `adjustment factor' applicable to a fiscal
year that is the Consumer Price Index for all urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All
items) of the preceding fiscal year divided by such Index for
September 2011.
``(2) The term `affiliate' means a business entity that has
a relationship with a second business entity if, directly or
indirectly--
``(A) one business entity controls, or has the power
to control, the other business entity; or
``(B) a third party controls, or has power to
control, both of the business entities.
``(3) The term `biosimilar biological product' means a
product for which a biosimilar biological product application
has been approved.
``(4)(A) Subject to subparagraph (B), the term `biosimilar
biological product application' means an application for
licensure of a biological product under section 351(k) of the
Public Health Service Act.
``(B) Such term does not include--
``(i) a supplement to such an application;
[[Page 1027]]
``(ii) an application filed under section 351(k) of
the Public Health Service Act that cites as the
reference product a bovine blood product for topical
application licensed before September 1, 1992, or a
large volume parenteral drug product approved before
such date;
``(iii) an application filed under section 351(k) of
the Public Health Service Act with respect to--
``(I) whole blood or a blood component for
transfusion;
``(II) an allergenic extract product;
``(III) an in vitro diagnostic biological
product; or
``(IV) a biological product for further
manufacturing use only; or
``(iv) an application for licensure under section
351(k) of the Public Health Service Act that is
submitted by a State or Federal Government entity for a
product that is not distributed commercially.
``(5) The term `biosimilar biological product development
meeting' means any meeting, other than a biosimilar initial
advisory meeting, regarding the content of a development
program, including a proposed design for, or data from, a study
intended to support a biosimilar biological product application.
``(6) The term `biosimilar biological product development
program' means the program under this part for expediting the
process for the review of submissions in connection with
biosimilar biological product development.
``(7)(A) The term `biosimilar biological product
establishment' means a foreign or domestic place of business--
``(i) that is at one general physical location
consisting of one or more buildings, all of which are
within 5 miles of each other; and
``(ii) at which one or more biosimilar biological
products are manufactured in final dosage form.
``(B) For purposes of subparagraph (A)(ii), the term
`manufactured' does not include packaging.
``(8) The term `biosimilar initial advisory meeting'--
``(A) means a meeting, if requested, that is limited
to--
``(i) a general discussion regarding whether
licensure under section 351(k) of the Public
Health Service Act may be feasible for a
particular product; and
``(ii) if so, general advice on the expected
content of the development program; and
``(B) does not include any meeting that involves
substantive review of summary data or full study
reports.
``(9) The term `costs of resources allocated for the process
for the review of biosimilar biological product applications'
means the expenses in connection with the process for the review
of biosimilar biological product applications for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related
to such officers employees and committees and to
contracts with such contractors;
``(B) management of information, and the
acquisition, maintenance, and repair of computer
resources;
[[Page 1028]]
``(C) leasing, maintenance, renovation, and repair
of facilities and acquisition, maintenance, and repair
of fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(D) collecting fees under section 744H and
accounting for resources allocated for the review of
submissions in connection with biosimilar biological
product development, biosimilar biological product
applications, and supplements.
``(10) The term `final dosage form' means, with respect to a
biosimilar biological product, a finished dosage form which is
approved for administration to a patient without substantial
further manufacturing (such as lyophilized products before
reconstitution).
``(11) The term `financial hold'--
``(A) means an order issued by the Secretary to
prohibit the sponsor of a clinical investigation from
continuing the investigation if the Secretary determines
that the investigation is intended to support a
biosimilar biological product application and the
sponsor has failed to pay any fee for the product
required under subparagraph (A), (B), or (D) of section
744H(a)(1); and
``(B) does not mean that any of the bases for a
`clinical hold' under section 505(i)(3) have been
determined by the Secretary to exist concerning the
investigation.
``(12) The term `person' includes an affiliate of such
person.
``(13) The term `process for the review of biosimilar
biological product applications' means the following activities
of the Secretary with respect to the review of submissions in
connection with biosimilar biological product development,
biosimilar biological product applications, and supplements:
``(A) The activities necessary for the review of
submissions in connection with biosimilar biological
product development, biosimilar biological product
applications, and supplements.
``(B) Actions related to submissions in connection
with biosimilar biological product development, the
issuance of action letters which approve biosimilar
biological product applications or which set forth in
detail the specific deficiencies in such applications,
and where appropriate, the actions necessary to place
such applications in condition for approval.
``(C) The inspection of biosimilar biological
product establishments and other facilities undertaken
as part of the Secretary's review of pending biosimilar
biological product applications and supplements.
``(D) Activities necessary for the release of lots
of biosimilar biological products under section 351(k)
of the Public Health Service Act.
``(E) Monitoring of research conducted in connection
with the review of biosimilar biological product
applications.
``(F) Postmarket safety activities with respect to
biologics approved under biosimilar biological product
applications or supplements, including the following
activities:
``(i) Collecting, developing, and reviewing
safety information on biosimilar biological
products, including adverse-event reports.
[[Page 1029]]
``(ii) Developing and using improved adverse-
event data-collection systems, including
information technology systems.
``(iii) Developing and using improved
analytical tools to assess potential safety
problems, including access to external data bases.
``(iv) Implementing and enforcing section
505(o) (relating to postapproval studies and
clinical trials and labeling changes) and section
505(p) (relating to risk evaluation and mitigation
strategies).
``(v) Carrying out section 505(k)(5) (relating
to adverse-event reports and postmarket safety
activities).
``(14) The term `supplement' means a request to the
Secretary to approve a change in a biosimilar biological product
application which has been approved, including a supplement
requesting that the Secretary determine that the biosimilar
biological product meets the standards for interchangeability
described in section 351(k)(4) of the Public Health Service Act.
``SEC. 744H. <> AUTHORITY TO ASSESS AND USE
BIOSIMILAR BIOLOGICAL PRODUCT FEES.
``(a) Types of Fees.-- <> Beginning in fiscal
year 2013, the Secretary shall assess and collect fees in accordance
with this section as follows:
``(1) Biosimilar development program fees.--
``(A) Initial biosimilar biological product
development fee.--
``(i) In general.--Each person that submits to
the Secretary a meeting request described under
clause (ii) or a clinical protocol for an
investigational new drug protocol described under
clause (iii) shall pay for the product named in
the meeting request or the investigational new
drug application the initial biosimilar biological
product development fee established under
subsection (b)(1)(A).
``(ii) Meeting request.--The meeting request
described in this clause is a request for a
biosimilar biological product development meeting
for a product.
``(iii) Clinical protocol for ind.--A clinical
protocol for an investigational new drug protocol
described in this clause is a clinical protocol
consistent with the provisions of section 505(i),
including any regulations promulgated under
section 505(i), (referred to in this section as
`investigational new drug application') describing
an investigation that the Secretary determines is
intended to support a biosimilar biological
product application for a product.
``(iv) Due date.--The initial biosimilar
biological product development fee shall be due by
the earlier of the following:
``(I) Not later than 5 days after
the Secretary grants a request for a
biosimilar biological product
development meeting.
``(II) The date of submission of an
investigational new drug application
describing an investigation that the
Secretary determines is intended
[[Page 1030]]
to support a biosimilar biological
product application.
``(v) Transition rule.--
<> Each person that has
submitted an investigational new drug application
prior to the date of enactment of the Biosimilars
User Fee Act of 2012 shall pay the initial
biosimilar biological product development fee by
the earlier of the following:
``(I) Not later than 60 days after
the date of the enactment of the
Biosimilars User Fee Act of 2012, if the
Secretary determines that the
investigational new drug application
describes an investigation that is
intended to support a biosimilar
biological product application.
``(II) Not later than 5 days after
the Secretary grants a request for a
biosimilar biological product
development meeting.
``(B) Annual biosimilar biological product
development fee.--
``(i) In general.--A person that pays an
initial biosimilar biological product development
fee for a product shall pay for such product,
beginning in the fiscal year following the fiscal
year in which the initial biosimilar biological
product development fee was paid, an annual fee
established under subsection (b)(1)(B) for
biosimilar biological product development
(referred to in this section as `annual biosimilar
biological product development fee').
``(ii) Due date.--The annual biosimilar
biological product development program fee for
each fiscal year will be due on the later of--
``(I) the first business day on or
after October 1 of each such year; or
``(II) the first business day after
the enactment of an appropriations Act
providing for the collection and
obligation of fees for such year under
this section.
``(iii) Exception.--The annual biosimilar
development program fee for each fiscal year will
be due on the date specified in clause (ii),
unless the person has--
``(I) submitted a marketing
application for the biological product
that was accepted for filing; or
``(II) discontinued participation in
the biosimilar biological product
development program for the product
under subparagraph (C).
``(C) Discontinuation of fee obligation.--
<> A person may discontinue
participation in the biosimilar biological product
development program for a product effective October 1 of
a fiscal year by, not later than August 1 of the
preceding fiscal year--
``(i) if no investigational new drug
application concerning the product has been
submitted, submitting to the Secretary a written
declaration that the person has no present
intention of further developing the product as a
biosimilar biological product; or
``(ii) if an investigational new drug
application concerning the product has been
submitted, withdrawing
[[Page 1031]]
the investigational new drug application in
accordance with part 312 of title 21, Code of
Federal Regulations (or any successor
regulations).
``(D) Reactivation fee.--
``(i) In general.--A person that has
discontinued participation in the biosimilar
biological product development program for a
product under subparagraph (C) shall pay a fee
(referred to in this section as `reactivation
fee') by the earlier of the following:
``(I) <> Not later
than 5 days after the Secretary grants a
request for a biosimilar biological
product development meeting for the
product (after the date on which such
participation was discontinued).
``(II) Upon the date of submission
(after the date on which such
participation was discontinued) of an
investigational new drug application
describing an investigation that the
Secretary determines is intended to
support a biosimilar biological product
application for that product.
``(ii) Application of annual fee.--A person
that pays a reactivation fee for a product shall
pay for such product, beginning in the next fiscal
year, the annual biosimilar biological product
development fee under subparagraph (B).
``(E) Effect of failure to pay biosimilar
development program fees.--
``(i) No biosimilar biological product
development meetings.--If a person has failed to
pay an initial or annual biosimilar biological
product development fee as required under
subparagraph (A) or (B), or a reactivation fee as
required under subparagraph (D), the Secretary
shall not provide a biosimilar biological product
development meeting relating to the product for
which fees are owed.
``(ii) No receipt of investigational new drug
applications.--Except in extraordinary
circumstances, the Secretary shall not consider an
investigational new drug application to have been
received under section 505(i)(2) if--
``(I) the Secretary determines that
the investigation is intended to support
a biosimilar biological product
application; and
``(II) the sponsor has failed to pay
an initial or annual biosimilar
biological product development fee for
the product as required under
subparagraph (A) or (B), or a
reactivation fee as required under
subparagraph (D).
``(iii) Financial hold.--Notwithstanding
section 505(i)(2), except in extraordinary
circumstances, the Secretary shall prohibit the
sponsor of a clinical investigation from
continuing the investigation if--
``(I) the Secretary determines that
the investigation is intended to support
a biosimilar biological product
application; and
[[Page 1032]]
``(II) the sponsor has failed to pay
an initial or annual biosimilar
biological product development fee for
the product as required under
subparagraph (A) or (B), or a
reactivation fee for the product as
required under subparagraph (D).
``(iv) No acceptance of biosimilar biological
product applications or supplements.--If a person
has failed to pay an initial or annual biosimilar
biological product development fee as required
under subparagraph (A) or (B), or a reactivation
fee as required under subparagraph (D), any
biosimilar biological product application or
supplement submitted by that person shall be
considered incomplete and shall not be accepted
for filing by the Secretary until all such fees
owed by such person have been paid.
``(F) Limits regarding biosimilar development
program fees.--
``(i) No refunds.--The Secretary shall not
refund any initial or annual biosimilar biological
product development fee paid under subparagraph
(A) or (B), or any reactivation fee paid under
subparagraph (D).
``(ii) No waivers, exemptions, or
reductions.--The Secretary shall not grant a
waiver, exemption, or reduction of any initial or
annual biosimilar biological product development
fee due or payable under subparagraph (A) or (B),
or any reactivation fee due or payable under
subparagraph (D).
``(2) Biosimilar biological product application and
supplement fee.--
``(A) In general.--Each person that submits, on or
after October 1, 2012, a biosimilar biological product
application or a supplement shall be subject to the
following fees:
``(i) A fee for a biosimilar biological
product application that is equal to--
``(I) the amount of the fee
established under subsection (b)(1)(D)
for a biosimilar biological product
application for which clinical data
(other than comparative bioavailability
studies) with respect to safety or
effectiveness are required for approval;
minus
``(II) the cumulative amount of fees
paid, if any, under subparagraphs (A),
(B), and (D) of paragraph (1) for the
product that is the subject of the
application.
``(ii) A fee for a biosimilar biological
product application for which clinical data (other
than comparative bioavailability studies) with
respect to safety or effectiveness are not
required, that is equal to--
``(I) half of the amount of the fee
established under subsection (b)(1)(D)
for a biosimilar biological product
application; minus
``(II) the cumulative amount of fees
paid, if any, under subparagraphs (A),
(B), and (D) of paragraph (1) for that
product.
``(iii) A fee for a supplement for which
clinical data (other than comparative
bioavailability studies)
[[Page 1033]]
with respect to safety or effectiveness are
required, that is equal to half of the amount of
the fee established under subsection (b)(1)(D) for
a biosimilar biological product application.
``(B) Reduction in fees.--Notwithstanding section
404 of the Biosimilars User Fee Act of 2012, any person
who pays a fee under subparagraph (A), (B), or (D) of
paragraph (1) for a product before October 1, 2017, but
submits a biosimilar biological product application for
that product after such date, shall be entitled to the
reduction of any biosimilar biological product
application fees that may be assessed at the time when
such biosimilar biological product application is
submitted, by the cumulative amount of fees paid under
subparagraphs (A), (B), and (D) of paragraph (1) for
that product.
``(C) Payment due date.--Any fee required by
subparagraph (A) shall be due upon submission of the
application or supplement for which such fee applies.
``(D) Exception for previously filed application or
supplement.--If a biosimilar biological product
application or supplement was submitted by a person that
paid the fee for such application or supplement, was
accepted for filing, and was not approved or was
withdrawn (without a waiver), the submission of a
biosimilar biological product application or a
supplement for the same product by the same person (or
the person's licensee, assignee, or successor) shall not
be subject to a fee under subparagraph (A).
``(E) Refund of application fee if application
refused for filing or withdrawn before filing.--The
Secretary shall refund 75 percent of the fee paid under
this paragraph for any application or supplement which
is refused for filing or withdrawn without a waiver
before filing.
``(F) Fees for applications previously refused for
filing or withdrawn before filing.--A biosimilar
biological product application or supplement that was
submitted but was refused for filing, or was withdrawn
before being accepted or refused for filing, shall be
subject to the full fee under subparagraph (A) upon
being resubmitted or filed over protest, unless the fee
is waived under subsection (c).
``(3) Biosimilar biological product establishment fee.--
``(A) In general.--Except as provided in
subparagraph (E), each person that is named as the
applicant in a biosimilar biological product application
shall be assessed an annual fee established under
subsection (b)(1)(E) for each biosimilar biological
product establishment that is listed in the approved
biosimilar biological product application as an
establishment that manufactures the biosimilar
biological product named in such application.
``(B) Assessment in fiscal years.--The establishment
fee shall be assessed in each fiscal year for which the
biosimilar biological product named in the application
is assessed a fee under paragraph (4) unless the
biosimilar biological product establishment listed in
the application
[[Page 1034]]
does not engage in the manufacture of the biosimilar
biological product during such fiscal year.
``(C) Due date.--The establishment fee for a fiscal
year shall be due on the later of--
``(i) the first business day on or after
October 1 of such fiscal year; or
``(ii) the first business day after the
enactment of an appropriations Act providing for
the collection and obligation of fees for such
fiscal year under this section.
``(D) Application to establishment.--
``(i) Each biosimilar biological product
establishment shall be assessed only one fee per
biosimilar biological product establishment,
notwithstanding the number of biosimilar
biological products manufactured at the
establishment, subject to clause (ii).
``(ii) In the event an establishment is listed
in a biosimilar biological product application by
more than one applicant, the establishment fee for
the fiscal year shall be divided equally and
assessed among the applicants whose biosimilar
biological products are manufactured by the
establishment during the fiscal year and assessed
biosimilar biological product fees under paragraph
(4).
``(E) Exception for new products.--If, during the
fiscal year, an applicant initiates or causes to be
initiated the manufacture of a biosimilar biological
product at an establishment listed in its biosimilar
biological product application--
``(i) that did not manufacture the biosimilar
biological product in the previous fiscal year;
and
``(ii) for which the full biosimilar
biological product establishment fee has been
assessed in the fiscal year at a time before
manufacture of the biosimilar biological product
was begun,
the applicant shall not be assessed a share of the
biosimilar biological product establishment fee for the
fiscal year in which the manufacture of the product
began.
``(4) Biosimilar biological product fee.--
``(A) In general.--Each person who is named as the
applicant in a biosimilar biological product application
shall pay for each such biosimilar biological product
the annual fee established under subsection (b)(1)(F).
``(B) Due date.--The biosimilar biological product
fee for a fiscal year shall be due on the later of--
``(i) the first business day on or after
October 1 of each such year; or
``(ii) the first business day after the
enactment of an appropriations Act providing for
the collection and obligation of fees for such
year under this section.
``(C) One fee per product per year.--The biosimilar
biological product fee shall be paid only once for each
product for each fiscal year.
``(b) Fee Setting and Amounts.--
``(1) In general.-- <> Subject to
paragraph (2), the Secretary shall, 60 days before the start of
each fiscal year that begins after September 30, 2012,
establish, for the next fiscal year,
[[Page 1035]]
the fees under subsection (a). Except as provided in subsection
(c), such fees shall be in the following amounts:
``(A) Initial biosimilar biological product
development fee.--The initial biosimilar biological
product development fee under subsection (a)(1)(A) for a
fiscal year shall be equal to 10 percent of the amount
established under section 736(c)(4) for a human drug
application described in section 736(a)(1)(A)(i) for
that fiscal year.
``(B) Annual biosimilar biological product
development fee.--The annual biosimilar biological
product development fee under subsection (a)(1)(B) for a
fiscal year shall be equal to 10 percent of the amount
established under section 736(c)(4) for a human drug
application described in section 736(a)(1)(A)(i) for
that fiscal year.
``(C) Reactivation fee.--The reactivation fee under
subsection (a)(1)(D) for a fiscal year shall be equal to
20 percent of the amount of the fee established under
section 736(c)(4) for a human drug application described
in section 736(a)(1)(A)(i) for that fiscal year.
``(D) Biosimilar biological product application
fee.--The biosimilar biological product application fee
under subsection (a)(2) for a fiscal year shall be equal
to the amount established under section 736(c)(4) for a
human drug application described in section
736(a)(1)(A)(i) for that fiscal year.
``(E) Biosimilar biological product establishment
fee.--The biosimilar biological product establishment
fee under subsection (a)(3) for a fiscal year shall be
equal to the amount established under section 736(c)(4)
for a prescription drug establishment for that fiscal
year.
``(F) Biosimilar biological product fee.--The
biosimilar biological product fee under subsection
(a)(4) for a fiscal year shall be equal to the amount
established under section 736(c)(4) for a prescription
drug product for that fiscal year.
``(2) Limit.--The total amount of fees charged for a fiscal
year under this section may not exceed the total amount for such
fiscal year of the costs of resources allocated for the process
for the review of biosimilar biological product applications.
``(c) Application Fee Waiver for Small Business.--
``(1) Waiver of application fee.--The Secretary shall grant
to a person who is named in a biosimilar biological product
application a waiver from the application fee assessed to that
person under subsection (a)(2)(A) for the first biosimilar
biological product application that a small business or its
affiliate submits to the Secretary for review. After a small
business or its affiliate is granted such a waiver, the small
business or its affiliate shall pay--
``(A) application fees for all subsequent biosimilar
biological product applications submitted to the
Secretary for review in the same manner as an entity
that is not a small business; and
``(B) all supplement fees for all supplements to
biosimilar biological product applications submitted to
the
[[Page 1036]]
Secretary for review in the same manner as an entity
that is not a small business.
``(2) Considerations.--In determining whether to grant a
waiver of a fee under paragraph (1), the Secretary shall
consider only the circumstances and assets of the applicant
involved and any affiliate of the applicant.
``(3) Small business defined.--In this subsection, the term
`small business' means an entity that has fewer than 500
employees, including employees of affiliates, and does not have
a drug product that has been approved under a human drug
application (as defined in section 735) or a biosimilar
biological product application (as defined in section 744G(4))
and introduced or delivered for introduction into interstate
commerce.
``(d) Effect of Failure To Pay Fees.--A biosimilar biological
product application or supplement submitted by a person subject to fees
under subsection (a) shall be considered incomplete and shall not be
accepted for filing by the Secretary until all fees owed by such person
have been paid.
``(e) Crediting and Availability of Fees.--
``(1) In general.--Subject to paragraph (2), fees authorized
under subsection (a) shall be collected and available for
obligation only to the extent and in the amount provided in
advance in appropriations Acts. Such fees are authorized to
remain available until expended. Such sums as may be necessary
may be transferred from the Food and Drug Administration
salaries and expenses appropriation account without fiscal year
limitation to such appropriation account for salaries and
expenses with such fiscal year limitation. The sums transferred
shall be available solely for the process for the review of
biosimilar biological product applications.
``(2) Collections and appropriation acts.--
``(A) In general.--Subject to subparagraphs (C) and
(D), the fees authorized by this section shall be
collected and available in each fiscal year in an amount
not to exceed the amount specified in appropriation
Acts, or otherwise made available for obligation for
such fiscal year.
``(B) Use of fees and limitation.--The fees
authorized by this section shall be available for a
fiscal year beginning after fiscal year 2012 to defray
the costs of the process for the review of biosimilar
biological product applications (including such costs
for an additional number of full-time equivalent
positions in the Department of Health and Human Services
to be engaged in such process), only if the Secretary
allocates for such purpose an amount for such fiscal
year (excluding amounts from fees collected under this
section) no less than $20,000,000, multiplied by the
adjustment factor applicable to the fiscal year
involved.
``(C) Fee collection during first program year.--
Until the date of enactment of an Act making
appropriations through September 30, 2013, for the
salaries and expenses account of the Food and Drug
Administration, fees authorized by this section for
fiscal year 2013 may be collected and shall be credited
to such account and remain available until expended.
``(D) Provision for early payments in subsequent
years.--Payment of fees authorized under this section
for
[[Page 1037]]
a fiscal year (after fiscal year 2013), prior to the due
date for such fees, may be accepted by the Secretary in
accordance with authority provided in advance in a prior
year appropriations Act.
``(3) Authorization of appropriations.--For each of fiscal
years 2013 through 2017, there is authorized to be appropriated
for fees under this section an amount equivalent to the total
amount of fees assessed for such fiscal year under this section.
``(f) Collection of Unpaid Fees.--In any case where the Secretary
does not receive payment of a fee assessed under subsection (a) within
30 days after it is due, such fee shall be treated as a claim of the
United States Government subject to subchapter II of chapter 37 of title
31, United States Code.
``(g) Written Requests for Waivers and Refunds.--
<> To qualify for consideration for a waiver under
subsection (c), or for a refund of any fee collected in accordance with
subsection (a)(2)(A), a person shall submit to the Secretary a written
request for such waiver or refund not later than 180 days after such fee
is due.
``(h) Construction.--This section may not be construed to require
that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employers, and advisory
committees not engaged in the process of the review of biosimilar
biological product applications, be reduced to offset the number of
officers, employees, and advisory committees so engaged.''.
SEC. 403. REAUTHORIZATION; REPORTING REQUIREMENTS.
Part 8 of subchapter C of chapter VII, as added by section 402, is
further amended by inserting after section 744H the following:
``SEC. 744I. <> REAUTHORIZATION; REPORTING
REQUIREMENTS.
``(a) Performance Report.-- <> Beginning with
fiscal year 2013, not later than 120 days after the end of each fiscal
year for which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of the House
of Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report concerning the progress of the Food and
Drug Administration in achieving the goals identified in the letters
described in section 401(b) of the Biosimilar User Fee Act of 2012
during such fiscal year and the future plans of the Food and Drug
Administration for meeting such goals. The report for a fiscal year
shall include information on all previous cohorts for which the
Secretary has not given a complete response on all biosimilar biological
product applications and supplements in the cohort.
``(b) Fiscal Report.--Not later than 120 days after the end of
fiscal year 2013 and each subsequent fiscal year for which fees are
collected under this part, the Secretary shall prepare and submit to the
Committee on Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the Senate a
report on the implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration, of the
fees collected for such fiscal year.
``(c) Public Availability.-- <> The Secretary
shall make the reports required under subsections (a) and (b) available
to the
[[Page 1038]]
public on the Internet Web site of the Food and Drug Administration.
``(d) Study.-- <>
``(1) In general.-- <> The Secretary shall
contract with an independent accounting or consulting firm to
study the workload volume and full costs associated with the
process for the review of biosimilar biological product
applications.
``(2) Interim results.--Not later than June 1, 2015, the
Secretary shall publish, for public comment, interim results of
the study described under paragraph (1).
``(3) Final results.--Not later than September 30, 2016, the
Secretary shall publish, for public comment, the final results
of the study described under paragraph (1).
``(e) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals described in
subsection (a), and plans for meeting the goals, for the process
for the review of biosimilar biological product applications for
the first 5 fiscal years after fiscal year 2017, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the
House of Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) health care professionals;
``(E) representatives of patient and consumer
advocacy groups; and
``(F) the regulated industry.
``(2) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under
paragraph (1) to the congressional committees specified
in such paragraph;
``(B) <> publish such recommendations in the
Federal Register;
``(C) <> provide for a period of
30 days for the public to provide written comments on
such recommendations;
``(D) hold a meeting at which the public may present
its views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(3) Transmittal of recommendations.--Not later than
January 15, 2017, the Secretary shall transmit to the Congress
the revised recommendations under paragraph (2), a summary of
the views and comments received under such paragraph, and any
changes made to the recommendations in response to such views
and comments.''.
SEC. 404. SUNSET DATES.
(a) Authorization.-- <> Sections 744G
and 744H of the Federal Food, Drug, and Cosmetic Act, as added by
section 402 of this Act, shall cease to be effective October 1, 2017.
(b) Reporting Requirements.-- <> Section
744I of the Federal Food, Drug, and Cosmetic Act, as added by section
403 of this Act, shall cease to be effective January 31, 2018.
[[Page 1039]]
SEC. 405. <> EFFECTIVE DATE.
(a) In General.--Except as provided under subsection (b), the
amendments made by this title shall take effect on the later of--
(1) October 1, 2012; or
(2) the date of the enactment of this title.
(b) Exception.--Fees under part 8 of subchapter C of chapter VII of
the Federal Food, Drug, and Cosmetic Act, as added by this title, shall
be assessed for all biosimilar biological product applications received
on or after October 1, 2012, regardless of the date of the enactment of
this title.
SEC. 406. <> SAVINGS CLAUSE.
Notwithstanding <> the amendments
made by this title, part 2 of subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act, as in effect on the day before the date of
the enactment of this title, shall continue to be in effect with respect
to human drug applications and supplements (as defined in such part as
of such day) that were accepted by the Food and Drug Administration for
filing on or after October 1, 2007, but before October 1, 2012, with
respect to assessing and collecting any fee required by such part for a
fiscal year prior to fiscal year 2013.
SEC. 407. CONFORMING AMENDMENT.
Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amended by striking ``or
(k)''.
SEC. 408. ADDITIONAL REPORTING REQUIREMENTS.
Section 715, <> as added by section 308 of
this Act, is amended by adding at the end the following:
``(b) Biosimilar Biological Products.--
``(1) In general.-- <> Beginning with
fiscal year 2014, not later than 120 days after the end of each
fiscal year for which fees are collected under part 8 of
subchapter C, the Secretary shall prepare and submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives a report concerning--
``(A) the number of applications for approval filed
under section 351(k) of the Public Health Service Act;
and
``(B) the percentage of applications described in
subparagraph (A) that were approved by the Secretary.
``(2) Additional information.--As part of the performance
report described in paragraph (1), the Secretary shall include
an explanation of how the Food and Drug Administration is
managing the biological product review program to ensure that
the user fees collected under part 2 are not used to review an
application under section 351(k) of the Public Health Service
Act.''.
TITLE V--PEDIATRIC DRUGS AND DEVICES
SEC. 501. PERMANENCE.
(a) Pediatric Studies of Drugs.--Section 505A (21 U.S.C. 355a) is
amended by striking subsection (q) (relating to a sunset).
[[Page 1040]]
(b) Research Into Pediatric Uses for Drugs and Biological
Products.--Section 505B (21 U.S.C. 355c) is amended--
(1) by striking subsection (m); and
(2) by redesignating subsection (n) as subsection (m).
SEC. 502. WRITTEN REQUESTS.
(a) In General.--
(1) Federal food, drug, and cosmetic act.--Subsection (h) of
section 505A (21 U.S.C. 355a) is amended to read as follows:
``(h) Relationship to Pediatric Research Requirements.--Exclusivity
under this section shall only be granted for the completion of a study
or studies that are the subject of a written request and for which
reports are submitted and accepted in accordance with subsection (d)(3).
Written requests under this section may consist of a study or studies
required under section 505B.''.
(2) Public health service act.--Section 351(m)(1) of the
Public Health Service Act (42 U.S.C. 262(m)(1)) is amended by
striking ``(f), (i), (j), (k), (l), (p), and (q)'' and inserting
``(f), (h), (i), (j), (k), (l), (n), and (p)''.
(b) Neonates.-- <> Subparagraph (A) of section
505A(d)(1) is amended by adding at the end the following: ``If a request
under this subparagraph does not request studies in neonates, such
request shall include a statement describing the rationale for not
requesting studies in neonates.''.
SEC. 503. <> COMMUNICATION WITH PEDIATRIC
REVIEW COMMITTEE.
Not <> later than 1 year after the
date of enactment of this Act, the Secretary of Health and Human
Services (referred to in this title as the ``Secretary'') shall issue
internal standard operating procedures that provide for the review by
the internal review committee established under section 505C of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355d) of any significant
modifications to initial pediatric study plans, agreed initial pediatric
study plans, and written requests under sections 505A and 505B of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a,
355c). <> Such internal standard
operating procedures shall be made publicly available on the Internet
Web site of the Food and Drug Administration.
SEC. 504. <> ACCESS TO DATA.
Not <> later than 3 years after the date of enactment of this Act,
the Secretary shall make available to the public, including through
posting on the Internet Web site of the Food and Drug Administration,
the medical, statistical, and clinical pharmacology reviews of, and
corresponding written requests issued to an applicant, sponsor, or
holder for, pediatric studies submitted between January 4, 2002, and
September 27, 2007, under subsection (b) or (c) of section 505A of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) for which 6 months
of market exclusivity was granted and that resulted in a labeling
change. The Secretary shall make public the information described in the
preceding sentence in a manner consistent with how the Secretary
releases information under section 505A(k) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355a(k)).
SEC. 505. ENSURING THE COMPLETION OF PEDIATRIC STUDIES.
(a) Extension of Deadline for Deferred Studies.--Section 505B (21
U.S.C. 355c) is amended--
[[Page 1041]]
(1) in subsection (a)(3)--
(A) by redesignating subparagraph (B) as
subparagraph (C);
(B) by inserting after subparagraph (A) the
following:
``(B) Deferral extension.--
``(i) In general.--On the initiative of the
Secretary or at the request of the applicant, the
Secretary may grant an extension of a deferral
approved under subparagraph (A) for submission of
some or all assessments required under paragraph
(1) if--
``(I) the Secretary determines that
the conditions described in subclause
(II) or (III) of subparagraph (A)(i)
continue to be met; and
``(II) the applicant submits a new
timeline under subparagraph (A)(ii)(IV)
and any significant updates to the
information required under subparagraph
(A)(ii).
``(ii) Timing and information.--If the
deferral extension under this subparagraph is
requested by the applicant, the applicant shall
submit the deferral extension request containing
the information described in this subparagraph not
less than 90 days prior to the date that the
deferral would expire. The Secretary shall respond
to such request not later than 45 days after the
receipt of such letter. If the Secretary grants
such an extension, the specified date shall be the
extended date. The sponsor of the required
assessment under paragraph (1) shall not be issued
a letter described in subsection (d) unless the
specified or extended date of submission for such
required studies has passed or if the request for
an extension is pending. For a deferral that has
expired prior to the date of enactment of the Food
and Drug Administration Safety and Innovation Act
or that will expire prior to 270 days after the
date of enactment of such Act, a deferral
extension shall be requested by an applicant not
later than 180 days after the date of enactment of
such Act. The Secretary shall respond to any such
request as soon as practicable, but not later than
1 year after the date of enactment of such Act.
Nothing in this clause shall prevent the Secretary
from updating the status of a study or studies
publicly if components of such study or studies
are late or delayed.''; and
(C) in subparagraph (C), as so redesignated--
(i) in clause (i), by adding at the end the
following:
``(III) Projected completion date
for pediatric studies.
``(IV) The reason or reasons why a
deferral or deferral extension continues
to be necessary.''; and
(ii) by amending clause (ii) to read as
follows:
``(ii) Public availability.--Not later than 90
days after the submission to the Secretary of the
information submitted through the annual review
under clause (i), <> the
Secretary shall make available to the public in an
easily accessible manner, including through the
[[Page 1042]]
Internet Web site of the Food and Drug
Administration--
``(I) such information;
``(II) the name of the applicant for
the product subject to the assessment;
``(III) the date on which the
product was approved; and
``(IV) the date of each deferral or
deferral extension under this paragraph
for the product.''; and
(2) in subsection (f)--
(A) in the subsection heading, by inserting
``Deferral Extensions,'' after ``Deferrals,'';
(B) in paragraph (1), by inserting ``, deferral
extension,'' after ``deferral''; and
(C) in paragraph (4)--
(i) in the paragraph heading, by inserting
``deferral extensions,'' after ``deferrals,''; and
(ii) by inserting ``, deferral extensions,''
after ``deferrals''.
(b) Tracking of Extensions; Annual Information.--Section
505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) is amended to read as follows:
``(D) aggregated on an annual basis--
``(i) the total number of deferrals and
deferral extensions requested and granted under
this section and, if granted, the reasons for each
such deferral or deferral extension;
``(ii) the timeline for completion of the
assessments; and
``(iii) the number of assessments completed
and pending;''.
(c) Action on Failure To Complete Studies.--
(1) Issuance of letter.--Subsection (d) of section 505B (21
U.S.C. 355c) is amended to read as follows:
``(d) Submission of Assessments.-- <> If a
person fails to submit a required assessment described in subsection
(a)(2), fails to meet the applicable requirements in subsection (a)(3),
or fails to submit a request for approval of a pediatric formulation
described in subsection (a) or (b), in accordance with applicable
provisions of subsections (a) and (b), the following shall apply:
``(1) <> Beginning 270
days after the date of enactment of the Food and Drug
Administration Safety and Innovation Act, the Secretary shall
issue a non-compliance letter to such person informing them of
such failure to submit or meet the requirements of the
applicable subsection. <> Such letter shall
require the person to respond in writing within 45 calendar days
of issuance of such letter. Such response may include the
person's request for a deferral extension if
applicable. <> Such
letter and the person's written response to such letter shall be
made publicly available on the Internet Web site of the Food and
Drug Administration 60 calendar days after issuance, with
redactions for any trade secrets and confidential commercial
information. If the Secretary determines that the letter was
issued in error, the requirements of this paragraph shall not
apply.
``(2) The drug or biological product that is the subject of
an assessment described in subsection (a)(2), applicable
[[Page 1043]]
requirements in subsection (a)(3), or request for approval of a
pediatric formulation, may be considered misbranded solely
because of that failure and subject to relevant enforcement
action (except that the drug or biological product shall not be
subject to action under section 303), but such failure shall not
be the basis for a proceeding--
``(A) to withdraw approval for a drug under section
505(e); or
``(B) to revoke the license for a biological product
under section 351 of the Public Health Service Act.''.
(2) Tracking of letters issued.--Subparagraph (D) of section
505B(f)(6) (21 U.S.C. 355c(f)(6)), as amended by subsection (b),
is further amended--
(A) in clause (ii), by striking ``; and'' and
inserting a semicolon;
(B) in clause (iii), by adding ``and'' at the end;
and
(C) by adding at the end the following:
``(iv) the number of postmarket non-compliance
letters issued pursuant to subsection (d), and the
recipients of such letters;''.
SEC. 506. <> PEDIATRIC STUDY PLANS.
(a) In General.--Subsection (e) of section 505B (21 U.S.C. 355c) is
amended to read as follows:
``(e) Pediatric Study Plans.--
``(1) In general.--An applicant subject to subsection (a)
shall submit to the Secretary an initial pediatric study plan
prior to the submission of the assessments described under
subsection (a)(2).
``(2) Timing; content; meeting.--
``(A) Timing.--An applicant shall submit the initial
pediatric plan under paragraph (1)--
``(i) before the date on which the applicant
submits the assessments under subsection (a)(2);
and
``(ii) not later than--
``(I) 60 calendar days after the
date of the end-of-Phase 2 meeting (as
such term is used in section 312.47 of
title 21, Code of Federal Regulations,
or successor regulations); or
``(II) such other time as may be
agreed upon between the Secretary and
the applicant.
Nothing in this section shall preclude the Secretary
from accepting the submission of an initial pediatric
plan earlier than the date otherwise applicable under
this subparagraph.
``(B) Content of initial plan.--The initial
pediatric study plan shall include--
``(i) an outline of the pediatric study or
studies that the applicant plans to conduct
(including, to the extent practicable study
objectives and design, age groups, relevant
endpoints, and statistical approach);
``(ii) any request for a deferral, partial
waiver, or waiver under this section, if
applicable, along with any supporting information;
and
``(iii) other information specified in the
regulations promulgated under paragraph (7).
``(C) Meeting.--The Secretary--
[[Page 1044]]
``(i) shall meet with the applicant to discuss
the initial pediatric study plan as soon as
practicable, but not later than 90 calendar days
after the receipt of such plan under subparagraph
(A);
``(ii) may determine that a written response
to the initial pediatric study plan is sufficient
to communicate comments on the initial pediatric
study plan, and that no meeting is necessary; and
``(iii) if the Secretary determines that no
meeting is necessary, shall so notify the
applicant and provide written comments of the
Secretary as soon as practicable, but not later
than 90 calendar days after the receipt of the
initial pediatric study plan.
``(3) Agreed initial pediatric study plan.--
<> Not later than 90 calendar days
following the meeting under paragraph (2)(C)(i) or the receipt
of a written response from the Secretary under paragraph
(2)(C)(iii), the applicant shall document agreement on the
initial pediatric study plan in a submission to the Secretary
marked `Agreed Initial Pediatric Study Plan', and the Secretary
shall confirm such agreement to the applicant in writing not
later than 30 calendar days of receipt of such agreed initial
pediatric study plan.
``(4) Deferral and waiver.--If the agreed initial pediatric
study plan contains a request from the applicant for a deferral,
partial waiver, or waiver under this section, the written
confirmation under paragraph (3) shall include a recommendation
from the Secretary as to whether such request meets the
standards under paragraphs (3) or (4) of subsection (a).
``(5) Amendments to the plan.-- <> At
the initiative of the Secretary or the applicant, the agreed
initial pediatric study plan may be amended at any time. The
requirements of paragraph (2)(C) shall apply to any such
proposed amendment in the same manner and to the same extent as
such requirements apply to an initial pediatric study plan under
paragraph (1). The requirements of paragraphs (3) and (4) shall
apply to any agreement resulting from such proposed amendment in
the same manner and to the same extent as such requirements
apply to an agreed initial pediatric study plan.
``(6) Internal committee.-- <> The
Secretary shall consult the internal committee under section
505C on the review of the initial pediatric study plan, agreed
initial pediatric plan, and any significant amendments to such
plans.
``(7) Required rulemaking.--Not later than 1 year after the
date of enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall promulgate proposed
regulations and issue guidance to implement the provisions of
this subsection.''.
(b) Conforming Amendments.--Section 505B (21 U.S.C. 355c) is
amended--
(1) by amending subclause (II) of subsection (a)(3)(A)(ii)
to read as follows:
``(II) a pediatric study plan as
described in subsection (e);''; and
(2) in subsection (f)--
(A) in the subsection heading, by striking
``pediatric Plans,'' and inserting ``pediatric Study
Plans,'';
[[Page 1045]]
(B) in paragraph (1), by striking ``all pediatric
plans'' and inserting ``initial pediatric study plans,
agreed initial pediatric study plans,''; and
(C) in paragraph (4)--
(i) in the paragraph heading, by striking
``pediatric Plans,'' and inserting ``pediatric
Study Plans,''; and
(ii) by striking ``pediatric plans'' and
inserting ``initial pediatric study plans, agreed
initial pediatric study plans,''.
(c) Effective Date.-- <>
(1) In general.--Subject to paragraph (2), the amendments
made by this section shall take effect 180 calendar days after
the date of enactment of this Act, irrespective of whether the
Secretary has promulgated final regulations to carry out such
amendments.
(2) Rule of construction.--Paragraph (1) shall not be
construed to affect the deadline for promulgation of proposed
regulations under section 505B(e)(7) of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a) of this section.
SEC. 507. REAUTHORIZATIONS.
(a) Pediatric Advisory Committee.--Section 14(d) of the Best
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended by
striking ``during the five-year period beginning on the date of the
enactment of the Best Pharmaceuticals for Children Act of 2007'' and
inserting ``to carry out the advisory committee's responsibilities under
sections 505A, 505B, and 520(m) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355a, 355c, and 360j(m))''.
(b) Pediatric Subcommittee of the Oncologic Drugs Advisory
Committee.--Section 15(a)(3) of the Best Pharmaceuticals for Children
Act (Public Law 107-109), as amended by section 502(e) of the Food and
Drug Administration Amendments Act of 2007 (Public Law 110-85), is
amended by striking ``during the five-year period beginning on the date
of the enactment of the Best Pharmaceuticals for Children Act of 2007''
and inserting ``for the duration of the operation of the Oncologic Drugs
Advisory Committee''.
(c) Humanitarian Device Exemption Extension.--Section
520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360j(m)(6)(A)(iv)) is amended by striking ``2012'' and inserting
``2017''.
(d) Program for Pediatric Study of Drugs in PHSA.--Section
409I(e)(1) of the Public Health Service Act (42 U.S.C. 284m(e)(1)) is
amended by striking ``to carry out this section'' and all that follows
through the end of paragraph (1) and inserting ``to carry out this
section, $25,000,000 for each of fiscal years 2013 through 2017.''.
SEC. 508. <> REPORT.
(a) In General.-- <> Not
later than four years after the date of enactment of this Act and every
five years thereafter, the Secretary shall prepare and submit to the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives,
and make publicly available, including through posting on the Internet
Web site of the Food and Drug Administration, a report on the
[[Page 1046]]
implementation of sections 505A and 505B of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a, 355c).
(b) Contents.--Each report under subsection (a) shall include--
(1) an assessment of the effectiveness of sections 505A and
505B of the Federal Food, Drug, and Cosmetic Act in improving
information about pediatric uses for approved drugs and
biological products, including the number and type of labeling
changes made since the date of enactment of this Act and the
importance of such uses in the improvement of the health of
children;
(2) the number of required studies under such section 505B
that have not met the initial deadline provided under such
section 505B, including--
(A) the number of deferrals and deferral extensions
granted and the reasons such extensions were granted;
(B) the number of waivers and partial waivers
granted; and
(C) the number of letters issued under subsection
(d) of such section 505B;
(3) an assessment of the timeliness and effectiveness of
pediatric study planning since the date of enactment of this
Act, including the number of initial pediatric study plans not
submitted in accordance with the requirements of subsection (e)
of such section 505B and any resulting rulemaking;
(4) the number of written requests issued, accepted, and
declined under such section 505A since the date of enactment of
this Act, and a listing of any important gaps in pediatric
information as a result of such declined requests;
(5) a description and current status of referrals made under
subsection (n) of such section 505A;
(6) an assessment of the effectiveness of studying
biological products in pediatric populations under such sections
505A and 505B and section 409I of the Public Health Service Act
(42 U.S.C. 284m);
(7)(A) the efforts made by the Secretary to increase the
number of studies conducted in the neonatal population
(including efforts made to encourage the conduct of appropriate
studies in neonates by companies with products that have
sufficient safety and other information to make the conduct of
the studies ethical and safe); and
(B) the results of such efforts;
(8)(A) the number and importance of drugs and biological
products for children with cancer that are being tested as a
result of the programs under such sections 505A and 505B and
under section 409I of the Public Health Service Act; and
(B) any recommendations for modifications to such programs
that would lead to new and better therapies for children with
cancer, including a detailed rationale for each recommendation;
(9) any recommendations for modification to such programs
that would improve pediatric drug research and increase
pediatric labeling of drugs and biological products;
(10) an assessment of the successes of and limitations to
studying drugs for rare diseases under such sections 505A and
505B; and
[[Page 1047]]
(11) an assessment of the Secretary's efforts to address the
suggestions and options described in any prior report issued by
the Comptroller General, Institute of Medicine, or the
Secretary, and any subsequent reports, including recommendations
therein, regarding the topics addressed in the reports under
this section, including with respect to--
(A) improving public access to information from
pediatric studies conducted under such sections 505A and
505B; and
(B) improving the timeliness of pediatric studies
and pediatric study planning under such sections 505A
and 505B.
(c) Stakeholder Comment.-- <> At
least 180 days prior to the submission of each report under subsection
(a), the Secretary shall consult with representatives of patient groups
(including pediatric patient groups), consumer groups, regulated
industry, academia, and other interested parties to obtain any
recommendations or information relevant to the report including
suggestions for modifications that would improve pediatric drug research
and pediatric labeling of drugs and biological products.
SEC. 509. TECHNICAL AMENDMENTS.
(a) Pediatric Studies of Drugs in FFDCA.--Section 505A (21 U.S.C.
355a) is amended--
(1) in subsection (k)(2), by striking ``subsection
(f)(3)(F)'' and inserting ``subsection (f)(6)(F)'';
(2) in subsection (l)--
(A) in paragraph (1)--
(i) in the paragraph heading, by striking
``year one'' and inserting ``first 18-month
period''; and
(ii) by striking ``one-year'' and inserting
``18-month'';
(B) in paragraph (2)--
(i) in the paragraph heading, by striking
``years'' and inserting ``periods''; and
(ii) by striking ``one-year period'' and
inserting ``18-month period'';
(C) by redesignating paragraph (3) as paragraph (4);
and
(D) by inserting after paragraph (2) the following:
``(3) Preservation of authority.--Nothing in this subsection
shall prohibit the Office of Pediatric Therapeutics from
providing for the review of adverse event reports by the
Pediatric Advisory Committee prior to the 18-month period
referred to in paragraph (1), if such review is necessary to
ensure safe use of a drug in a pediatric population.'';
(3) in subsection (n)--
(A) in the subsection heading, by striking
``completed'' and inserting ``submitted''; and
(B) in paragraph (1)--
(i) in the matter preceding subparagraph (A),
by striking ``have not been completed'' and
inserting ``have not been submitted by the date
specified in the written request issued or if the
applicant or holder does not agree to the
request'';
(ii) in subparagraph (A)--
[[Page 1048]]
(I) in the first sentence, by
inserting ``, or for which a period of
exclusivity eligible for extension under
subsection (b)(1) or (c)(1) of this
section or under subsection (m)(2) or
(m)(3) of section 351 of the Public
Health Service Act has not ended'' after
``expired''; and
(II) by striking ``Prior to'' and
all that follows through the period at
the end; and
(iii) in subparagraph (B), by striking ``no
listed patents or has 1 or more listed patents
that have expired,'' and inserting ``no unexpired
listed patents and for which no unexpired periods
of exclusivity eligible for extension under
subsection (b)(1) or (c)(1) of this section or
under subsection (m)(2) or (m)(3) of section 351
of the Public Health Service Act apply,''; and
(4) in subsection (o)(2), by amending subparagraph (B) to
read as follows:
``(B) a statement of any appropriate pediatric
contraindications, warnings, precautions, or other
information that the Secretary considers necessary to
assure safe use.''.
(b) Research Into Pediatric Uses for Drugs and Biological Projects
in FFDCA.--Section 505B (21 U.S.C. 355c) is amended--
(1) in subsection (a)--
(A) in paragraph (1), in the matter before
subparagraph (A), by inserting ``for a drug'' after
``(or supplement to an application)''; and
(B) in paragraph (4)(C)--
(i) in the first sentence, by inserting
``partial'' before ``waiver is granted''; and
(ii) in the second sentence, by striking
``either a full or'' and inserting ``such a'';
(2) in subsection (b)(1), in the matter preceding
subparagraph (A), by striking ``After providing notice'' and all
that follows through ``studies), the'' and inserting ``The'';
(3) in subsection (g)--
(A) in paragraph (1)(A), by inserting ``that
receives a priority review or 330 days after the date of
the submission of an application or supplement that
receives a standard review'' after ``after the date of
the submission of the application or supplement''; and
(B) in paragraph (2), by striking ``the label of
such product'' and inserting ``the labeling of such
product'';
(4) in subsection (h)(1)--
(A) by inserting ``an application (or supplement to
an application) that contains'' after ``date of
submission of''; and
(B) by inserting ``if the application (or
supplement) receives a priority review, or not later
than 330 days after the date of submission of an
application (or supplement to an application) that
contains a pediatric assessment under this section, if
the application (or supplement) receives a standard
review,'' after ``under this section,''; and
(5) in subsection (i)--
(A) in paragraph (1)--
[[Page 1049]]
(i) in the paragraph heading, by striking
``year one'' and inserting ``first 18-month
period''; and
(ii) by striking ``one-year'' and inserting
``18-month'';
(B) in paragraph (2)--
(i) in the paragraph heading, by striking
``years'' and inserting ``periods''; and
(ii) by striking ``one-year period'' and
inserting ``18-month period'';
(C) by redesignating paragraph (3) as paragraph (4);
and
(D) by inserting after paragraph (2) the following:
``(3) Preservation of authority.--Nothing in this subsection
shall prohibit the Office of Pediatric Therapeutics from
providing for the review of adverse event reports by the
Pediatric Advisory Committee prior to the 18-month period
referred to in paragraph (1), if such review is necessary to
ensure safe use of a drug in a pediatric population.''.
(c) Internal Committee for Review of Pediatric Plans, Assessments,
Deferrals, Deferral Extensions, and Waivers.--Section 505C (21 U.S.C.
355d) is amended--
(1) in the section heading, by inserting ``deferral
extensions,'' after ``deferrals,''; and
(2) by inserting ``neonatology,'' after ``pediatric
ethics,''.
(d) Program for Pediatric Studies of Drugs.--Section 409I(c) of the
Public Health Service Act (42 U.S.C. 284m(c)) is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph (A), by
inserting ``or section 351(m) of this Act,'' after
``Cosmetic Act,'';
(B) in subparagraph (A)(i), by inserting ``or
section 351(k) of this Act'' after ``Cosmetic Act''; and
(C) by amending subparagraph (B) to read as follows:
``(B) there remains no patent listed pursuant to
section 505(b)(1) of the Federal Food, Drug, and
Cosmetic Act, and every three-year and five-year period
referred to in subsection (c)(3)(E)(ii), (c)(3)(E)(iii),
(c)(3)(E)(iv), (j)(5)(F)(ii), (j)(5)(F)(iii), or
(j)(5)(F)(iv) of section 505 of the Federal Food, Drug,
and Cosmetic Act, or applicable twelve-year period
referred to in section 351(k)(7) of this Act, and any
seven-year period referred to in section 527 of the
Federal Food, Drug, and Cosmetic Act has ended for at
least one form of the drug; and''; and
(2) in paragraph (2)--
(A) in the paragraph heading, by striking ``for
drugs lacking exclusivity'';
(B) by striking ``under section 505 of the Federal
Food, Drug, and Cosmetic Act''; and
(C) by striking ``505A of such Act'' and inserting
``505A of the Federal Food, Drug, and Cosmetic Act or
section 351(m) of this Act''.
(e) Pediatric Subcommittee of the Oncologic Advisory Committee.--
Section 15(a) of the Best Pharmaceuticals for Children Act (Public Law
107-109), as amended by section 502(e) of the Food and Drug
Administration Amendments Act of 2007 (Public
[[Page 1050]]
Law 110-85), is amended in paragraph (1)(D), by striking ``section
505B(f)'' and inserting ``section 505C''.
(f) Foundation of National Institutes of Health.--Section
499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 290b(c)(1)(C))
is amended by striking ``for which the Secretary issues a certification
in the affirmative under section 505A(n)(1)(A) of the Federal Food,
Drug, and Cosmetic Act''.
(g) Application; Transition Rule.-- <>
(1) Application.-- <> Notwithstanding
any provision of section 505A and 505B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) stating that a
provision applies beginning on the date of the enactment of the
Best Pharmaceuticals for Children Act of 2007 or the date of the
enactment of the Pediatric Research Equity Act of 2007, any
amendment made by this Act to such a provision applies beginning
on the date of the enactment of this Act.
(2) <> Transitional rule for adverse
event reporting.--With respect to a drug for which a labeling
change described under section 505A(l)(1) or 505B(i)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(l)(1);
355c(i)(1)) is approved or made, respectively, during the one-
year period that ends on the day before the date of enactment of
this Act, the Secretary shall apply section 505A(l) and section
505B(i), as applicable, to such drug, as such sections were in
effect on such day.
SEC. 510. PEDIATRIC RARE DISEASES.
(a) Public Meeting.-- <> Not later than 18 months
after the date of enactment of this Act, the Secretary shall hold at
least one public meeting to discuss ways to encourage and accelerate the
development of new therapies for pediatric rare diseases.
(b) Report.-- <> Not later than 180 days
after the date of the public meeting under subsection (a), the Secretary
shall issue a report that includes a strategic plan for encouraging and
accelerating the development of new therapies for treating pediatric
rare diseases.
SEC. 511. STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS.
Section 6 of the Best Pharmaceuticals for Children Act (21 U.S.C.
393a) is amended--
(1) in subsection (c)--
(A) in paragraph (1), by striking ``and'' at the
end;
(B) by redesignating paragraph (2) as paragraph (4);
and
(C) by inserting after paragraph (1) the following:
``(2) subject to subsection (d), one or more additional
individuals with necessary expertise in a pediatric
subpopulation that is, as determined through consideration of
the reports and recommendations issued by the Institute of
Medicine and the Comptroller General of the United States, less
likely to be studied as a part of a written request issued under
section 505A of the Federal Food, Drug, and Cosmetic Act or an
assessment under section 505B of such Act;
``(3) one or more additional individuals with expertise in
pediatric epidemiology; and''; and
(2) by adding at the end the following:
``(d) Neonatology Expertise.-- <> For the 5-year period beginning on the date of enactment of this
subsection, at least one of the
[[Page 1051]]
individuals described in subsection (c)(2) shall have expertise in
neonatology.''.
TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS
SEC. 601. INVESTIGATIONAL DEVICE EXEMPTIONS.
Section 520(g) (21 U.S.C. 360j(g)) is amended--
(1) in paragraph (2)(B)(ii), by inserting ``safety or
effectiveness'' before ``data obtained''; and
(2) in paragraph (4), by adding at the end the following:
``(C) Consistent with paragraph (1), the Secretary shall not
disapprove an application under this subsection because the Secretary
determines that--
``(i) the investigation may not support a substantial
equivalence or de novo classification determination or approval
of the device;
``(ii) the investigation may not meet a requirement,
including a data requirement, relating to the approval or
clearance of a device; or
``(iii) an additional or different investigation may be
necessary to support clearance or approval of the device.''.
SEC. 602. CLARIFICATION OF LEAST BURDENSOME STANDARD.
(a) Premarket Approval.--Section 513(a)(3)(D) (21 U.S.C.
360c(a)(3)(D)) is amended--
(1) by redesignating clause (iii) as clause (v); and
(2) by inserting after clause (ii) the following:
``(iii) <> For purposes of clause (ii), the term
`necessary' means the minimum required information that would support a
determination by the Secretary that an application provides reasonable
assurance of the effectiveness of the device.
``(iv) Nothing in this subparagraph shall alter the criteria for
evaluating an application for premarket approval of a device.''.
(b) Premarket Notification Under Section 510(k).--Section
513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) is amended--
(1) by striking ``(D) Whenever'' and inserting ``(D)(i)
Whenever''; and
(2) by adding at the end the following:
``(ii) <> For purposes of clause (i), the term
`necessary' means the minimum required information that would support a
determination of substantial equivalence between a new device and a
predicate device.
``(iii) Nothing in this subparagraph shall alter the standard for
determining substantial equivalence between a new device and a predicate
device.''.
SEC. 603. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT
DECISIONS.
Chapter V is amended by inserting after section 517 (21 U.S.C. 360g)
the following:
``SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT
DECISIONS REGARDING DEVICES.
``(a) Documentation of Rationale for Significant Decisions.--
[[Page 1052]]
``(1) In general.--The Secretary shall provide a substantive
summary of the scientific and regulatory rationale for any
significant decision of the Center for Devices and Radiological
Health regarding submission or review of a report under section
510(k), an application under section 515, or an application for
an exemption under section 520(g), including documentation of
significant controversies or differences of opinion and the
resolution of such controversies or differences of opinion.
``(2) Provision of documentation.--Upon request, the
Secretary shall furnish such substantive summary to the person
who is seeking to submit, or who has submitted, such report or
application.
``(b) Review of Significant Decisions.--
``(1) Request for supervisory review of significant
decision.--Any person may request a supervisory review of the
significant decision described in subsection (a)(1). Such review
may be conducted at the next supervisory level or higher above
the individual who made the significant decision.
``(2) Submission of request.-- <> A person
requesting a supervisory review under paragraph (1) shall submit
such request to the Secretary not later than 30 days after such
decision and shall indicate in the request whether such person
seeks an in-person meeting or a teleconference review.
``(3) Timeframe.--
``(A) In general.--Except as provided in
subparagraph (B), the Secretary shall schedule an in-
person or teleconference review, if so requested, not
later than 30 days after such request is
made. <> The Secretary shall issue a
decision to the person requesting a review under this
subsection not later than 45 days after the request is
made under paragraph (1), or, in the case of a person
who requests an in-person meeting or teleconference, 30
days after such meeting or teleconference.
``(B) Exception.--Subparagraph (A) shall not apply
in cases that are referred to experts outside of the
Food and Drug Administration.''.
SEC. 604. DEVICE MODIFICATIONS REQUIRING PREMARKET NOTIFICATION
PRIOR TO MARKETING.
Section 510(n) (21 U.S.C. 360(n)) is amended by--
(1) striking ``(n) The Secretary'' and inserting ``(n)(1)
The Secretary''; and
(2) by adding at the end the following:
``(2)(A) <> Not later than 18
months after the date of enactment of this paragraph, the
Secretary shall submit to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report regarding
when a premarket notification under subsection (k) should be
submitted for a modification or change to a legally marketed
device. The report shall include the Secretary's interpretation
of the following terms: `could significantly affect the safety
or effectiveness of the device', `a significant change or
modification in design, material, chemical composition, energy
source, or manufacturing process', and `major change or
modification in the
[[Page 1053]]
intended use of the device'. The report also shall discuss
possible processes for industry to use to determine whether a
new submission under subsection (k) is required and shall
analyze how to leverage existing quality system requirements to
reduce premarket burden, facilitate continual device
improvement, and provide reasonable assurance of safety and
effectiveness of modified devices. In developing such report,
the Secretary shall consider the input of interested
stakeholders.
``(B) The Secretary shall withdraw the Food and Drug
Administration draft guidance entitled `Guidance for Industry
and FDA Staff--510(k) Device Modifications: Deciding When to
Submit a 510(k) for a Change to an Existing Device', dated July
27, 2011, and shall not use this draft guidance as part of, or
for the basis of, any premarket review or any compliance or
enforcement decisions or actions. The Secretary shall not
issue--
``(i) any draft guidance or proposed regulation that
addresses when to submit a premarket notification
submission for changes and modifications made to a
manufacturer's previously cleared device before the
receipt by the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate of the
report required in subparagraph (A); and
``(ii) any final guidance or regulation on that
topic for one year after date of receipt of such report
by the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate.
``(C) <> The Food and Drug
Administration guidance entitled `Deciding When to Submit a
510(k) for a Change to an Existing Device', dated January 10,
1997, shall be in effect until the subsequent issuance of
guidance or promulgation, if appropriate, of a regulation
described in subparagraph (B), and the Secretary shall interpret
such guidance in a manner that is consistent with the manner in
which the Secretary has interpreted such guidance since 1997.''.
SEC. 605. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.
Chapter V is amended by inserting after section 518 (21 U.S.C. 360h)
the following:
``SEC. 518A. <> PROGRAM TO IMPROVE THE
DEVICE RECALL SYSTEM.
``(a) In General.--The Secretary shall--
``(1) establish a program to routinely and systematically
assess information relating to device recalls and use such
information to proactively identify strategies for mitigating
health risks presented by defective or unsafe devices;
``(2) <> clarify procedures for
conducting device recall audit checks to improve the ability of
investigators to perform those checks in a consistent manner;
``(3) <> develop detailed criteria for
assessing whether a person performing a device recall has
performed an effective correction or action plan for the recall;
and
``(4) document the basis for each termination by the Food
and Drug Administration of a device recall.
``(b) Assessment Content.--The program established under subsection
(a)(1) shall, at a minimum, identify--
[[Page 1054]]
``(1) trends in the number and types of device recalls;
``(2) devices that are most frequently the subject of a
recall; and
``(3) underlying causes of device recalls.
``(c) Termination of Recalls.--The Secretary shall document the
basis for the termination by the Food and Drug Administration of a
device recall.
``(d) Definition.--In this section, the term `recall' means--
``(1) the removal from the market of a device pursuant to an
order of the Secretary under subsection (b) or (e) of section
518; or
``(2) the correction or removal from the market of a device
at the initiative of the manufacturer or importer of the device
that is required to be reported to the Secretary under section
519(g).''.
SEC. 606. CLINICAL HOLDS ON INVESTIGATIONAL DEVICE EXEMPTIONS.
Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end
the following:
``(8)(A) At any time, the Secretary may prohibit the sponsor of an
investigation from conducting the investigation (referred to in this
paragraph as a `clinical hold') if the Secretary makes a determination
described in subparagraph (B). The Secretary shall specify the basis for
the clinical hold, including the specific information available to the
Secretary which served as the basis for such clinical hold, and confirm
such determination in writing.
``(B) <> For purposes of subparagraph (A), a
determination described in this subparagraph with respect to a clinical
hold is a determination that--
``(i) the device involved represents an unreasonable risk to
the safety of the persons who are the subjects of the clinical
investigation, taking into account the qualifications of the
clinical investigators, information about the device, the design
of the clinical investigation, the condition for which the
device is to be investigated, and the health status of the
subjects involved; or
``(ii) the clinical hold should be issued for such other
reasons as the Secretary may by regulation establish.
``(C) <> Any written request to the
Secretary from the sponsor of an investigation that a clinical hold be
removed shall receive a decision, in writing and specifying the reasons
therefor, within 30 days after receipt of such request. Any such request
shall include sufficient information to support the removal of such
clinical hold.''.
SEC. 607. MODIFICATION OF DE NOVO APPLICATION PROCESS.
(a) In General.--Section 513(f)(2) (21 U.S.C. 360c(f)(2)) is
amended--
(1) by inserting ``(i)'' after ``(2)(A)'';
(2) in subparagraph (A)(i), as so designated by paragraph
(1), by striking ``under the criteria set forth'' and all that
follows through the end of subparagraph (A) and inserting a
period;
(3) by adding at the end of subparagraph (A) the following:
``(ii) In lieu of submitting a report under section 510(k) and
submitting a request for classification under clause (i) for a device,
if a person determines there is no legally marketed device upon which to
base a determination of substantial equivalence (as defined
[[Page 1055]]
in subsection (i)), a person may submit a request under this clause for
the Secretary to classify the device.
``(iii) <> Upon receipt of a
request under clause (i) or (ii), the Secretary shall classify the
device subject to the request under the criteria set forth in
subparagraphs (A) through (C) of subsection (a)(1) within 120 days.
``(iv) Notwithstanding clause (iii), the Secretary may decline to
undertake a classification request submitted under clause (ii) if the
Secretary identifies a legally marketed device that could provide a
reasonable basis for review of substantial equivalence under paragraph
(1), or when the Secretary determines that the device submitted is not
of low-moderate risk or that general controls would be inadequate to
control the risks and special controls to mitigate the risks cannot be
developed.
``(v) The person submitting the request for classification under
this subparagraph may recommend to the Secretary a classification for
the device and shall, if recommending classification in class II,
include in the request an initial draft proposal for applicable special
controls, as described in subsection (a)(1)(B), that are necessary, in
conjunction with general controls, to provide reasonable assurance of
safety and effectiveness and a description of how the special controls
provide such assurance. Any such request shall describe the device and
provide detailed information and reasons for the recommended
classification.''; and
(4) in subparagraph (B), by striking ``Not later than 60
days after the date of the submission of the request under
subparagraph (A), the Secretary'' and inserting ``The
Secretary''.
(b) Conforming Amendments.--Section 513(f) (21 U.S.C. 360c(f)) is
amended in paragraph (1)--
(1) in subparagraph (A), by striking ``, or'' at the end and
inserting a semicolon;
(2) in subparagraph (B), by striking the period and
inserting ``; or''; and
(3) by inserting after subparagraph (B) the following:
``(C) the device is classified pursuant to a request
submitted under paragraph (2).''.
SEC. 608. RECLASSIFICATION PROCEDURES.
(a) Classification Changes.--
(1) In general.--Section 513(e)(1) (21 U.S.C. 360c(e)(1)) is
amended to read as follows:
``(e)(1)(A)(i) <> Based on new
information respecting a device, the Secretary may, upon the initiative
of the Secretary or upon petition of an interested person, change the
classification of such device, and revoke, on account of the change in
classification, any regulation or requirement in effect under section
514 or 515 with respect to such device, by administrative order
published in the Federal Register following publication of a proposed
reclassification order in the Federal Register, a meeting of a device
classification panel described in subsection (b), and consideration of
comments to a public docket, notwithstanding subchapter II of chapter 5
of title 5, United States Code. The proposed reclassification order
published in the Federal Register shall set forth the proposed
reclassification, and a substantive summary of the valid scientific
evidence concerning the proposed reclassification, including--
[[Page 1056]]
``(I) the public health benefit of the use of the device,
and the nature and, if known, incidence of the risk of the
device;
``(II) in the case of a reclassification from class II to
class III, why general controls pursuant to subsection (a)(1)(A)
and special controls pursuant to subsection (a)(1)(B) together
are not sufficient to provide a reasonable assurance of safety
and effectiveness for such device; and
``(III) in the case of reclassification from class III to
class II, why general controls pursuant to subsection (a)(1)(A)
and special controls pursuant to subsection (a)(1)(B) together
are sufficient to provide a reasonable assurance of safety and
effectiveness for such device.
``(ii) An order under this subsection changing the classification of
a device from class III to class II may provide that such classification
shall not take effect until the effective date of a performance standard
established under section 514 for such device.
``(B) Authority to issue such administrative order shall not be
delegated below the Director of the Center for Devices and Radiological
Health, acting in consultation with the Commissioner.''.
(2) Technical and conforming amendments.--
(A) Section 513(e)(2) (21 U.S.C. 360c(e)(2)) is
amended by striking ``regulation promulgated'' and
inserting ``an order issued''.
(B) Section 514(a)(1) (21 U.S.C. 360d(a)(1)) is
amended by striking ``under a regulation under section
513(e) but such regulation'' and inserting ``under an
administrative order under section 513(e) (or a
regulation promulgated under such section prior to the
date of enactment of the Food and Drug Administration
Safety and Innovation Act) but such order (or
regulation)''.
(C) Section 517(a)(1) (21 U.S.C. 360g(a)(1)) is
amended by striking ``or changing the classification of
a device to class I'' and inserting ``, an
administrative order changing the classification of a
device to class I,''.
(3) <> Devices reclassified prior
to the date of enactment of this act.--
(A) In general.--The amendments made by this
subsection shall have no effect on a regulation
promulgated with respect to the classification of a
device under section 513(e) of the Federal Food, Drug,
and Cosmetic Act prior to the date of enactment of this
Act.
(B) Applicability of other provisions.--In the case
of a device reclassified under section 513(e) of the
Federal Food, Drug, and Cosmetic Act by regulation prior
to the date of enactment of this Act, section 517(a)(1)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360g(a)(1)) shall apply to such regulation promulgated
under section 513(e) of such Act with respect to such
device in the same manner such section 517(a)(1) applies
to an administrative order issued with respect to a
device reclassified after the date of enactment of this
Act.
(b) Devices Marketed Before May 28, 1976.--
(1) Premarket approval.--Section 515 (21 U.S.C. 360e) is
amended--
(A) in subsection (a), by striking ``regulation
promulgated under subsection (b)'' and inserting ``an
order issued
[[Page 1057]]
under subsection (b) (or a regulation promulgated under
such subsection prior to the date of enactment of the
Food and Drug Administration Safety and Innovation
Act)'';
(B) in subsection (b)--
(i) in paragraph (1)--
(I) in the heading, by striking
``Regulation'' and inserting ``Order'';
and
(II) in the matter following
subparagraph (B)--
(aa) by striking ``by
regulation, promulgated in
accordance with this
subsection'' and inserting ``by
administrative order following
publication of a proposed order
in the Federal Register, a
meeting of a device
classification panel described
in section 513(b), and
consideration of comments from
all affected stakeholders,
including patients, payors, and
providers, notwithstanding
subchapter II of chapter 5 of
title 5, United States Code'';
and
(bb) by adding at the end
the following: ``Authority to
issue such administrative order
shall not be delegated below the
Director of the Center for
Devices and Radiological Health,
acting in consultation with the
Commissioner.'';
(ii) in paragraph (2)--
(I) by striking subparagraph (B);
and
(II) in subparagraph (A)--
(aa) by striking ``(2)(A) A
proceeding for the promulgation
of a regulation under paragraph
(1) respecting a device shall be
initiated by the publication in
the Federal Register of a notice
of proposed rulemaking. Such
notice shall contain--'' and
inserting ``(2) A proposed order
required under paragraph (1)
shall contain--'';
(bb) by redesignating
clauses (i) through (iv) as
subparagraphs (A) through (D),
respectively;
(cc) in subparagraph (A), as
so redesignated, by striking
``regulation'' and inserting
``order''; and
(dd) in subparagraph (C), as
so redesignated, by striking
``regulation'' and inserting
``order'';
(iii) in paragraph (3)--
(I) by striking ``proposed
regulation'' each place such term
appears and inserting ``proposed
order'';
(II) by striking ``paragraph (2) and
after'' and inserting ``paragraph
(2),'';
(III) by inserting ``and a meeting
of a device classification panel
described in section 513(b),'' after
``such proposed regulation and
findings,'';
(IV) by striking ``(A) promulgate
such regulation'' and inserting ``(A)
issue an administrative order under
paragraph (1)'';
(V) by striking ``paragraph
(2)(A)(ii)'' and inserting ``paragraph
(2)(B)''; and
[[Page 1058]]
(VI) by striking ``promulgation of
the regulation'' and inserting
``issuance of the administrative
order''; and
(iv) by striking paragraph (4); and
(C) in subsection (i)--
(i) in paragraph (2)--
(I) in the matter preceding
subparagraph (A)--
(aa) by striking ``December
1, 1995'' and inserting ``the
date that is 2 years after the
date of enactment of the Food
and Drug Administration Safety
and Innovation Act''; and
(bb) by striking ``publish a
regulation in the Federal
Register'' and inserting ``issue
an administrative order
following publication of a
proposed order in the Federal
Register, a meeting of a device
classification panel described
in section 513(b), and
consideration of comments from
all affected stakeholders,
including patients, payors, and
providers, notwithstanding
subchapter II of chapter 5 of
title 5, United States Code,'';
(II) in subparagraph (B), by
striking ``final regulation has been
promulgated under section 515(b)'' and
inserting ``administrative order has
been issued under subsection (b) (or no
regulation has been promulgated under
such subsection prior to the date of
enactment of the Food and Drug
Administration Safety and Innovation
Act)'';
(III) in the matter following
subparagraph (B), by striking
``regulation requires'' and inserting
``administrative order issued under this
paragraph requires''; and
(IV) by striking the third and
fourth sentences; and
(ii) in paragraph (3)--
(I) by striking ``regulation
requiring'' each place such term appears
and inserting ``order requiring''; and
(II) by striking ``promulgation of a
section 515(b) regulation'' and
inserting ``issuance of an
administrative order under subsection
(b)''.
(2) Technical and conforming amendments.--Section 501(f) (21
U.S.C. 351(f)) is amended--
(A) in subparagraph (1)(A)--
(i) in subclause (i), by striking ``a
regulation promulgated'' and inserting ``an order
issued''; and
(ii) in subclause (ii), by striking
``promulgation of such regulation'' and inserting
``issuance of such order'';
(B) in subparagraph (2)(B)--
(i) by striking ``a regulation promulgated''
and inserting ``an order issued''; and
(ii) by striking ``promulgation of such
regulation'' and inserting ``issuance of such
order''; and
(C) by adding at the end the following:
``(3) In the case of a device with respect to which a regulation was
promulgated under section 515(b) prior to the date of enactment
[[Page 1059]]
of the Food and Drug Administration Safety and Innovation Act, a
reference in this subsection to an order issued under section 515(b)
shall be deemed to include such regulation.''.
(3) <> Approval by regulation prior
to the date of enactment of this 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.--T <> he Secretary
of Health and Human Services shall annually post on the Internet Web
site of the Food and Drug Administration--
(1) the number and type of class I and class II devices
reclassified as class II or class III in the previous calendar
year under section 513(e)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c(e)(1));
(2) the number and type of class II and class III devices
reclassified as class I or class II in the previous calendar
year under such section 513(e)(1); and
(3) the number and type of devices reclassified in the
previous calendar year under section 515 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360e).
SEC. 609. HARMONIZATION OF DEVICE PREMARKET REVIEW, INSPECTION,
AND LABELING SYMBOLS.
Paragraph (4) of section 803(c) (21 U.S.C. 383(c)) is amended to
read as follows:
``(4) With respect to devices, the Secretary may, when appropriate,
enter into arrangements with nations regarding methods and approaches to
harmonizing regulatory requirements for activities, including
inspections and common international labeling symbols.''.
SEC. 610. PARTICIPATION IN INTERNATIONAL FORA.
Paragraph (3) of section 803(c) (21 U.S.C. 383(c)) is amended--
(1) by striking ``(3)'' and inserting ``(3)(A)''; and
(2) by adding at the end the following:
``(B) In carrying out subparagraph (A), the Secretary may
participate in appropriate fora, including the International Medical
Device Regulators Forum, and may--
``(i) provide guidance to such fora on strategies, policies,
directions, membership, and other activities of a forum as
appropriate;
``(ii) to the extent appropriate, solicit, review, and
consider comments from industry, academia, health care
professionals, and patient groups regarding the activities of
such fora; and
``(iii) to the extent appropriate, inform the public of the
Secretary's activities within such fora, and share with the
public any documentation relating to a forum's strategies,
policies, and other activities of such fora.''.
SEC. 611. REAUTHORIZATION OF THIRD-PARTY REVIEW.
(a) Periodic Reaccreditation.--Section 523(b)(2) (21 U.S.C.
360m(b)(2)) is amended by adding at the end of the following:
``(E) Periodic reaccreditation.--
<>
``(i) Period.--Subject to suspension or
withdrawal under subparagraph (B), any
accreditation under this
[[Page 1060]]
section shall be valid for a period of 3 years
after its issuance.
``(ii) Response to reaccreditation request.--
Upon the submission of a request by an accredited
person for reaccreditation under this section, the
Secretary shall approve or deny such request not
later than 60 days after receipt of the request.
``(iii) Criteria.--Not later than 120 days
after the date of the enactment of this
subparagraph, the Secretary shall establish and
publish in the Federal Register criteria to
reaccredit or deny reaccreditation to persons
under this section. The reaccreditation of persons
under this section shall specify the particular
activities under subsection (a), and the devices,
for which such persons are reaccredited.''.
(b) Duration of Authority.--Section 523(c) (21 U.S.C. 360m(c)) is
amended by striking ``October 1, 2012'' and inserting ``October 1,
2017''.
SEC. 612. REAUTHORIZATION OF THIRD-PARTY INSPECTION.
Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amended by striking
``October 1, 2012'' and inserting ``October 1, 2017''.
SEC. 613. HUMANITARIAN DEVICE EXEMPTIONS.
(a) In General.--Section 520(m) (21 U.S.C. 360j(m)) is amended--
(1) in paragraph (6)--
(A) in subparagraph (A)--
(i) by striking clause (i) and inserting the
following:
``(i) The device with respect to which the exemption is
granted--
``(I) is intended for the treatment or diagnosis of
a disease or condition that occurs in pediatric patients
or in a pediatric subpopulation, and such device is
labeled for use in pediatric patients or in a pediatric
subpopulation in which the disease or condition occurs;
or
``(II) is intended for the treatment or diagnosis of
a disease or condition that does not occur in pediatric
patients or that occurs in pediatric patients in such
numbers that the development of the device for such
patients is impossible, highly impracticable, or
unsafe.''; and
(ii) by striking clause (ii) and inserting the
following:
``(ii) During any calendar year, the number of such devices
distributed during that year under each exemption granted under
this subsection does not exceed the annual distribution number
for such device. <> In this paragraph, the
term `annual distribution number' means the number of such
devices reasonably needed to treat, diagnose, or cure a
population of 4,000 individuals in the United
States. <> The Secretary shall determine
the annual distribution number when the Secretary grants such
exemption.''; and
(B) by amending subparagraph (C) to read as follows:
``(C) A person may petition the Secretary to modify the annual
distribution number determined by the Secretary under subparagraph
(A)(ii) with respect to a device if additional information arises, and
the Secretary may modify such annual distribution number.'';
[[Page 1061]]
(2) in paragraph (7), by striking ``regarding a device'' and
inserting ``regarding a device described in paragraph
(6)(A)(i)(I)''; and
(3) in paragraph (8), by striking ``of all devices described
in paragraph (6)'' and inserting ``of all devices described in
paragraph (6)(A)(i)(I)''.
(b) Applicability to Existing Devices.-- <> A sponsor of a device for which an exemption was
approved under paragraph (2) of section 520(m) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360j(m)) before the date of enactment
of this Act may seek a determination under subclause (I) or (II) of
section 520(m)(6)(A)(i) (as amended by subsection (a)). If the Secretary
of Health and Human Services determines that such subclause (I) or (II)
applies with respect to a device, clauses (ii), (iii), and (iv) of
subparagraph (A) and subparagraphs (B), (C), (D), and (E) of paragraph
(6) of such section 520(m) shall apply to such device, and the Secretary
shall determine the annual distribution number for purposes of clause
(ii) of such subparagraph (A) when making the determination under this
subsection.
SEC. 614. <> UNIQUE DEVICE IDENTIFIER.
Section 519(f) (21 U.S.C. 360i(f)) is amended--
(1) by striking ``The Secretary shall promulgate'' and
inserting ``Not later than December 31, 2012, the Secretary
shall issue proposed''; and
(2) by adding at the end the following: ``The Secretary
shall finalize the proposed regulations not later than 6 months
after the close of the comment period and shall implement the
final regulations with respect to devices that are implantable,
life-saving, and life sustaining not later than 2 years after
the regulations are finalized, taking into account patient
access to medical devices and therapies.''.
SEC. 615. SENTINEL.
Section 519 (21 U.S.C. 360i) is amended by adding at the end the
following:
``(h) Inclusion of Devices in the Postmarket Risk Identification and
Analysis System.--
``(1) In general.--
``(A) Application to devices.--
<> The Secretary shall amend the
procedures established and maintained under clauses (i),
(ii), (iii), and (v) of section 505(k)(3)(C) in order to
expand the postmarket risk identification and analysis
system established under such section to include and
apply to devices.
``(B) Exception.--Subclause (II) of clause (i) of
section 505(k)(3)(C) shall not apply to devices.
``(C) Clarification.--With respect to devices, the
private sector health-related electronic data provided
under section 505(k)(3)(C)(i)(III)(bb) may include
medical device utilization data, health insurance claims
data, and procedure and device registries.
``(2) Data.--In expanding the system as described in
paragraph (1)(A), the Secretary shall use relevant data with
respect to devices cleared under section 510(k) or approved
under section 515, including claims data, patient survey data,
and any other data deemed appropriate by the Secretary.
[[Page 1062]]
``(3) Stakeholder input.--To help ensure effective
implementation of the system as described in paragraph (1) with
respect to devices, the Secretary shall engage outside
stakeholders in development of the system, and gather
information from outside stakeholders regarding the content of
an effective sentinel program, through a public hearing,
advisory committee meeting, maintenance of a public docket, or
other similar public measures.
``(4) Voluntary surveys.--Chapter 35 of title 44, United
States Code, shall not apply to the collection of voluntary
information from health care providers, such as voluntary
surveys or questionnaires, initiated by the Secretary for
purposes of postmarket risk identification, mitigation, and
analysis for devices.''.
SEC. 616. POSTMARKET SURVEILLANCE.
Section 522 (21 U.S.C. 360l) is amended--
(1) in subsection (a)(1)(A), in the matter preceding clause
(i), by inserting ``, at the time of approval or clearance of a
device or at any time thereafter,'' after ``by order''; and
(2) <> in subsection (b)(1), by inserting
``The manufacturer shall commence surveillance under this
section not later than 15 months after the day on which the
Secretary issues an order under this section.'' after the second
sentence.
SEC. 617. CUSTOM DEVICES.
Section 520(b) (21 U.S.C. 360j(b)) is amended to read as follows:
``(b) Custom Devices.--
``(1) In general.--The requirements of sections 514 and 515
shall not apply to a device that--
``(A) is created or modified in order to comply with
the order of an individual physician or dentist (or any
other specially qualified person designated under
regulations promulgated by the Secretary after an
opportunity for an oral hearing);
``(B) in order to comply with an order described in
subparagraph (A), necessarily deviates from an otherwise
applicable performance standard under section 514 or
requirement under section 515;
``(C) is not generally available in the United
States in finished form through labeling or advertising
by the manufacturer, importer, or distributor for
commercial distribution;
``(D) is designed to treat a unique pathology or
physiological condition that no other device is
domestically available to treat;
``(E)(i) is intended to meet the special needs of
such physician or dentist (or other specially qualified
person so designated) in the course of the professional
practice of such physician or dentist (or other
specially qualified person so designated); or
``(ii) is intended for use by an individual patient
named in such order of such physician or dentist (or
other specially qualified person so designated);
``(F) is assembled from components or manufactured
and finished on a case-by-case basis to accommodate the
unique needs of individuals described in clause (i) or
(ii) of subparagraph (E); and
[[Page 1063]]
``(G) may have common, standardized design
characteristics, chemical and material compositions, and
manufacturing processes as commercially distributed
devices.
``(2) Limitations.-- <> Paragraph (1)
shall apply to a device only if--
``(A) such device is for the purpose of treating a
sufficiently rare condition, such that conducting
clinical investigations on such device would be
impractical;
``(B) production of such device under paragraph (1)
is limited to no more than 5 units per year of a
particular device type, provided that such replication
otherwise complies with this section; and
``(C) <> the
manufacturer of such device notifies the Secretary on an
annual basis, in a manner prescribed by the Secretary,
of the manufacture of such device.
``(3) Guidance.-- <> Not later than 2 years
after the date of enactment of this section, the Secretary shall
issue final guidance on replication of multiple devices
described in paragraph (2)(B).''.
SEC. 618. HEALTH INFORMATION TECHNOLOGY.
(a) Report.-- <> Not later than 18 months after
the date of enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary''), acting
through the Commissioner of Food and Drugs, and in consultation with the
National Coordinator for Health Information Technology and the Chairman
of the Federal Communications Commission, shall post on the Internet Web
sites of the Food and Drug Administration, the Federal Communications
Commission, and the Office of the National Coordinator for Health
Information Technology, a report that contains a proposed strategy and
recommendations on an appropriate, risk-based regulatory framework
pertaining to health information technology, including mobile medical
applications, that promotes innovation, protects patient safety, and
avoids regulatory duplication.
(b) Working Group.--
(1) In general.--In carrying out subsection (a), the
Secretary may convene a working group of external stakeholders
and experts to provide appropriate input on the strategy and
recommendations required for the report under subsection (a).
(2) Representatives.-- <> If the
Secretary convenes the working group under paragraph (1), the
Secretary, in consultation with the Commissioner of Food and
Drugs, the National Coordinator for Health Information
Technology, and the Chairman of the Federal Communications
Commission, shall determine the number of representatives
participating in the working group, and shall, to the extent
practicable, ensure that the working group is geographically
diverse and includes representatives of patients, consumers,
health care providers, startup companies, health plans or other
third-party payers, venture capital investors, information
technology vendors, health information technology vendors, small
businesses, purchasers, employers, and other stakeholders with
relevant expertise, as determined by the Secretary.
SEC. 619. GOOD GUIDANCE PRACTICES RELATING TO DEVICES.
Subparagraph (C) of section 701(h)(1) (21 U.S.C. 371(h)(1)) is
amended--
[[Page 1064]]
(1) by striking ``(C) For guidance documents'' and inserting
``(C)(i) For guidance documents''; and
(2) by adding at the end the following:
``(ii) <> With respect to devices, if a
notice to industry guidance letter, a notice to industry
advisory letter, or any similar notice sets forth initial
interpretations of a regulation or policy or sets forth changes
in interpretation or policy, such notice shall be treated as a
guidance document for purposes of this subparagraph.''.
SEC. 620. PEDIATRIC DEVICE CONSORTIA.
(a) In General.--Section 305(e) of Pediatric Medical Device Safety
and Improvement Act (Public Law 110-85; 42 U.S.C. 282 note)) is amended
by striking ``$6,000,000 for each of fiscal years 2008 through 2012''
and inserting ``$5,250,000 for each of fiscal years 2013 through 2017''.
(b) <> Final Rule Relating To
Tracking of Pediatric Uses of Devices.--The Secretary of Health and
Human Services shall issue--
(1) a proposed rule implementing section 515A(a)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(a)(2))
not later than December 31, 2012; and
(2) a final rule implementing such section not later than
December 31, 2013.
TITLE VII--DRUG SUPPLY CHAIN
SEC. 701. REGISTRATION OF DOMESTIC DRUG ESTABLISHMENTS.
Section 510 (21 U.S.C. 360) is amended--
(1) in subsection (b)--
(A) <> in paragraph (1), by
striking ``On or before'' and all that follows through
the period at the end and inserting the following:
``During the period beginning on October 1 and ending on
December 31 of each year, every person who owns or
operates any establishment in any State engaged in the
manufacture, preparation, propagation, compounding, or
processing of a drug or drugs shall register with the
Secretary the name of such person, places of business of
such person, all such establishments, the unique
facility identifier of each such establishment, and a
point of contact e-mail address.; and
(B) by adding at the end the following:
``(3) <> The Secretary shall specify the
unique facility identifier system that shall be used by registrants
under paragraph (1). The requirement to include a unique facility
identifier in a registration under paragraph (1) shall not apply until
the date that the identifier system is specified by the Secretary under
the preceding sentence.''; and
(2) in subsection (c), by striking ``with the Secretary his
name, place of business, and such establishment'' and inserting
``with the Secretary--
``(1) with respect to drugs, the information described under
subsection (b)(1); and
``(2) with respect to devices, the information described
under subsection (b)(2).''.
[[Page 1065]]
SEC. 702. REGISTRATION OF FOREIGN ESTABLISHMENTS.
(a) Enforcement of Registration of Foreign Establishments.--Section
502(o) (21 U.S.C. 352(o)) is amended by striking ``in any State''.
(b) Registration of Foreign Drug Establishments.--Section 510(i)
(U.S.C. 360(i)) is <> amended--
(1) in paragraph (1)--
(A) by amending the matter preceding subparagraph
(A) to read as follows: ``Every person who owns or
operates any establishment within any foreign country
engaged in the manufacture, preparation, propagation,
compounding, or processing of a drug or device that is
imported or offered for import into the United States
shall, through electronic means in accordance with the
criteria of the Secretary--'';
(B) by amending subparagraph (A) to read as follows:
``(A) upon first engaging in any such activity, immediately
submit a registration to the Secretary that includes--
``(i) with respect to drugs, the name and place of
business of such person, all such establishments, the
unique facility identifier of each such establishment, a
point of contact e-mail address, the name of the United
States agent of each such establishment, the name of
each importer of such drug in the United States that is
known to the establishment, and the name of each person
who imports or offers for import such drug to the United
States for purposes of importation; and
``(ii) with respect to devices, the name and place
of business of the establishment, the name of the United
States agent for the establishment, the name of each
importer of such device in the United States that is
known to the establishment, and the name of each person
who imports or offers for import such device to the
United States for purposes of importation; and''; and
(C) by amending subparagraph (B) to read as follows:
``(B) <> each establishment subject to
the requirements of subparagraph (A) shall thereafter register
with the Secretary during the period beginning on October 1 and
ending on December 31 of each year.''; and
(2) by adding at the end the following:
``(4) <> The Secretary shall specify the
unique facility identifier system that shall be used by registrants
under paragraph (1) with respect to drugs. The requirement to include a
unique facility identifier in a registration under paragraph (1) with
respect to drugs shall not apply until the date that the identifier
system is specified by the Secretary under the preceding sentence.''.
SEC. 703. IDENTIFICATION OF DRUG EXCIPIENT INFORMATION WITH
PRODUCT LISTING.
Section 510(j) (21 U.S.C. 360(j)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (C), by striking ``; and'' and
inserting a semicolon;
(B) in subparagraph (D), by striking the period at
the end and inserting ``; and''; and
(C) by adding at the end the following:
[[Page 1066]]
``(E) in the case of a drug contained in the applicable
list, the name and place of business of each manufacturer of an
excipient of the listed drug with which the person listing the
drug conducts business, including all establishments used in the
production of such excipient, the unique facility identifier of
each such establishment, and a point of contact e-mail address
for each such excipient manufacturer.''; and
(2) by adding at the end the following:
``(4) The Secretary shall require persons subject to this subsection
to use, for purposes of this subsection, the unique facility identifier
systems specified under subsections (b)(3) and (i)(4) with respect to
drugs. Such requirement shall not apply until the date that the
identifier system under subsection (b)(3) or (i)(4), as applicable, is
specified by the Secretary.''.
SEC. 704. ELECTRONIC SYSTEM FOR REGISTRATION AND LISTING.
Section 510(p) (21 U.S.C. 360(p)) is amended--
(1) by striking ``(p) Registrations and listings'' and
inserting the following:
``(p) Electronic Registration and Listing.--
``(1) In general.--Registrations and listings''; and
(2) by adding at the end the following:
``(2) Electronic database.-- <> Not later
than 2 years after the Secretary specifies a unique facility
identifier system under subsections (b) and (i), the Secretary
shall maintain an electronic database, which shall not be
subject to inspection under subsection (f), populated with the
information submitted as described under paragraph (1) that--
``(A) enables personnel of the Food and Drug
Administration to search the database by any field of
information submitted in a registration described under
paragraph (1), or combination of such fields; and
``(B) uses the unique facility identifier system to
link with other relevant databases within the Food and
Drug Administration, including the database for
submission of information under section 801(r).
``(3) Risk-based information and coordination.--The
Secretary shall ensure the accuracy and coordination of relevant
Food and Drug Administration databases in order to identify and
inform risk-based inspections under section 510(h).''.
SEC. 705. RISK-BASED INSPECTION FREQUENCY.
Section 510(h) (21 U.S.C. 360(h)) is amended to read as follows:
``(h) Inspections.--
``(1) In general.--Every establishment that is required to
be registered with the Secretary under this section shall be
subject to inspection pursuant to section 704.
``(2) Biennial inspections for devices.--Every establishment
described in paragraph (1), in any State, that is engaged in the
manufacture, propagation, compounding, or processing of a device
or devices classified in class II or III shall be so inspected
by one or more officers or employees duly designated by the
Secretary, or by persons accredited to conduct inspections under
section 704(g), at least once in the 2-year period beginning
with the date of registration of such establishment pursuant to
this section and at least once in every successive 2-year period
thereafter.
[[Page 1067]]
``(3) Risk-based schedule for drugs.--The Secretary, acting
through one or more officers or employees duly designated by the
Secretary, shall inspect establishments described in paragraph
(1) that are engaged in the manufacture, preparation,
propagation, compounding, or processing of a drug or drugs
(referred to in this subsection as `drug establishments') in
accordance with a risk-based schedule established by the
Secretary.
``(4) Risk factors.--In establishing the risk-based
scheduled under paragraph (3), the Secretary shall inspect
establishments according to the known safety risks of such
establishments, which shall be based on the following factors:
``(A) The compliance history of the establishment.
``(B) The record, history, and nature of recalls
linked to the establishment.
``(C) The inherent risk of the drug manufactured,
prepared, propagated, compounded, or processed at the
establishment.
``(D) The inspection frequency and history of the
establishment, including whether the establishment has
been inspected pursuant to section 704 within the last 4
years.
``(E) Whether the establishment has been inspected
by a foreign government or an agency of a foreign
government recognized under section 809.
``(F) Any other criteria deemed necessary and
appropriate by the Secretary for purposes of allocating
inspection resources.
``(5) Effect of status.--In determining the risk associated
with an establishment for purposes of establishing a risk-based
schedule under paragraph (3), the Secretary shall not consider
whether the drugs manufactured, prepared, propagated,
compounded, or processed by such establishment are drugs
described in section 503(b).
``(6) <> Annual report on inspections
of establishments.--Beginning in 2014, not later than February 1
of each year, the Secretary shall make available on the Internet
Web site of the Food and Drug Administration a report
regarding--
``(A)(i) the number of domestic and foreign
establishments registered pursuant to this section in
the previous fiscal year; and
``(ii) the number of such domestic establishments
and the number of such foreign establishments that the
Secretary inspected in the previous fiscal year;
``(B) with respect to establishments that
manufacture, prepare, propagate, compound, or process an
active ingredient of a drug, a finished drug product, or
an excipient of a drug, the number of each such type of
establishment; and
``(C) the percentage of the budget of the Food and
Drug Administration used to fund the inspections
described under subparagraph (A).''.
SEC. 706. RECORDS FOR INSPECTION.
Section 704(a) (21 U.S.C. 374(a)) is amended by adding at the end
the following:
[[Page 1068]]
``(4)(A) Any records or other information that the Secretary may
inspect under this section from a person that owns or operates an
establishment that is engaged in the manufacture, preparation,
propagation, compounding, or processing of a drug shall, upon the
request of the Secretary, be provided to the Secretary by such person,
in advance of or in lieu of an inspection, within a reasonable
timeframe, within reasonable limits, and in a reasonable manner, and in
either electronic or physical form, at the expense of such person. The
Secretary's request shall include a sufficient description of the
records requested.
``(B) <> Upon receipt of the records requested
under subparagraph (A), the Secretary shall provide to the person
confirmation of receipt.
``(C) Nothing in this paragraph supplants the authority of the
Secretary to conduct inspections otherwise permitted under this Act in
order to ensure compliance with this Act.''.
SEC. 707. PROHIBITION AGAINST DELAYING, DENYING, LIMITING, OR
REFUSING INSPECTION.
(a) In General.--Section 501 (21 U.S.C. 351) is amended by adding at
the end the following:
``(j) If it is a drug and it has been manufactured, processed,
packed, or held in any factory, warehouse, or establishment and the
owner, operator, or agent of such factory, warehouse, or establishment
delays, denies, or limits an inspection, or refuses to permit entry or
inspection.''.
(b) <> Guidance.--Not later than 1
year after the date of enactment of this section, the Secretary of
Health and Human Services shall issue guidance that defines the
circumstances that would constitute delaying, denying, or limiting
inspection, or refusing to permit entry or inspection, for purposes of
section 501(j) of the Federal Food, Drug, and Cosmetic Act (as added by
subsection (a)).
SEC. 708. DESTRUCTION OF ADULTERATED, MISBRANDED, OR COUNTERFEIT
DRUGS OFFERED FOR IMPORT.
(a) In General.--The sixth sentence of section 801(a) (21 U.S.C.
381(a)) is amended by inserting before the period at the end the
following: ``, except that the Secretary of Health and Human Services
may destroy, without the opportunity for export, any drug refused
admission under this section, if such drug is valued at an amount that
is $2,500 or less (or such higher amount as the Secretary of the
Treasury may set by regulation pursuant to section 498(a)(1) of the
Tariff Act of 1930 (19 U.S.C. 1498(a)(1)) and was not brought into
compliance as described under subsection (b).''.
(b) <> Notice.--Subsection (a) of section 801
(21 U.S.C. 381), as amended by subsection (a), is further amended by
inserting after the sixth sentence the following: ``The Secretary of
Health and Human Services shall issue regulations providing for notice
and an opportunity to appear before the Secretary of Health and Human
Services and introduce testimony, as described in the first sentence of
this subsection, on destruction of a drug under the sixth sentence of
this subsection. The regulations shall provide that prior to
destruction, appropriate due process is available to the owner or
consignee seeking to challenge the decision to destroy the drug. Where
the Secretary of Health and Human Services provides notice and an
opportunity to appear and introduce testimony on the destruction of a
drug, the Secretary of Health and Human Services shall store and, as
applicable, dispose of the drug
[[Page 1069]]
after the issuance of the notice, except that the owner and consignee
shall remain liable for costs pursuant to subsection (c). Such process
may be combined with the notice and opportunity to appear before the
Secretary and introduce testimony, as described in the first sentence of
this subsection, as long as appropriate notice is provided to the owner
or consignee.''.
(c) <> Applicability.--The amendment made by
subsection (a) shall apply beginning on the effective date of the
regulations promulgated pursuant to the amendment made by subsection
(b).
(d) <> Regulations.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act, the Secretary of Health and Human
Services shall adopt final regulations implementing the
amendments made this section.
(2) Procedure.--In promulgating a regulation implementing
the amendments made by this section, the Secretary of Health and
Human Services shall--
(A) <> issue a notice of proposed
rulemaking that includes a copy of the proposed
regulation;
(B) <> provide a period of not
less than 60 days for comments on the proposed
regulation; and
(C) <> publish the final
regulation not less than 30 days before the effective
date of the regulation.
(3) Restrictions.--Notwithstanding any other provision of
law, the Secretary of Health and Human Services shall promulgate
regulations implementing the amendments made by this section
only as described in paragraph (2).
SEC. 709. ADMINISTRATIVE DETENTION.
(a) <> In General.--Section 304(g) (21 U.S.C.
335a(g)) is amended--
(1) in paragraph (1), by inserting ``, drug,'' after
``device'', each place it appears;
(2) in paragraph (2)(A), by inserting ``, drug,'' after
``(B), a device''; and
(3) in paragraph (2)(B), by inserting ``or drug'' after
``device'' each place it appears.
(b) <> Regulations.--
(1) In general.--Not later than 2 years after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall promulgate regulations in accordance with section
304(i) of the Federal Food, Drug, and Cosmetic Act, as added by
paragraph (2) of this subsection, to implement administrative
detention authority with respect to drugs, as authorized by the
amendments made by subsection (a). Before promulgating such
regulations, the Secretary shall consult with stakeholders,
including manufacturers of drugs.
(2) In general.--Section 304 (21 U.S.C. 334) is amended by
adding at the end the following:
``(i) Procedures for Promulgating Regulations.--
``(1) In general.--In promulgating a regulation implementing
this section, the Secretary shall--
``(A) <> issue a notice of proposed
rulemaking that includes the proposed regulation;
``(B) <> provide a period of not
less than 60 days for comments on the proposed
regulation; and
[[Page 1070]]
``(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 Information
Obtained From Foreign Governments.--
``(1) In general.--The Secretary shall not be required to
disclose under section 552 of title 5, United States Code
(commonly referred to as the `Freedom of Information Act'), or
any other provision of law, any information relating to drugs
obtained from a foreign government agency, if--
``(A) the information concerns the inspection of a
facility, is part of an investigation, alerts the United
States to the potential need for an investigation, or
concerns a drug that has a reasonable probability of
causing serious adverse health consequences or death to
humans or animals;
``(B) the information is provided or made available
to the United States Government voluntarily on the
condition that it not be released to the public; and
``(C) the information is covered by, and subject to,
a written agreement between the Secretary and the
foreign government.
``(2) <> Time limitations.--The
written agreement described in paragraph (1)(C) shall specify
the time period for which paragraph (1) shall apply to the
voluntarily disclosed information. Paragraph (1) shall not
apply with respect to such information after the date specified
in such agreement, but all other applicable legal protections,
including the provisions of section 552 of title 5, United
States Code, and section 319L(e)(1) of the Public Health Service
Act, as applicable, shall continue to apply to such information.
If no date is specified in the written agreement, paragraph (1)
shall not apply with respect to such information for a period of
more than 36 months.
``(3) Disclosures not affected.--Nothing in this section
authorizes any official to withhold, or to authorize the
withholding of, information from Congress or information
required to be disclosed pursuant to an order of a court of the
United States.
``(4) Relation to other law.--For purposes of section 552 of
title 5, United States Code, this subsection shall be considered
a statute described in subsection (b)(3)(B) of such section 552.
[[Page 1071]]
``(c) Authority To Enter Into Memoranda of Understanding for
Purposes of Information Exchange.--The Secretary may enter into written
agreements to provide information referenced in section 301(j) to
foreign governments subject to the following criteria:
``(1) Certification.--The Secretary may enter into a written
agreement to provide information under this subsection to a
foreign government only if the Secretary has certified such
government as having the authority and demonstrated ability to
protect trade secret information from disclosure. Responsibility
for this certification shall not be delegated to any officer or
employee other than the Commissioner of Food and Drugs.
``(2) Written agreement.--The written agreement to provide
information to the foreign government under this subsection
shall include a commitment by the foreign government to protect
information exchanged under this subsection from disclosure
unless and until the sponsor gives written permission for
disclosure or the Secretary makes a declaration of a public
health emergency pursuant to section 319 of the Public Health
Service Act that is relevant to the information.
``(3) Information exchange.--The Secretary may provide to a
foreign government that has been certified under paragraph (1)
and that has executed a written agreement under paragraph (2)
information referenced in section 301(j) in only the following
circumstances:
``(A) Information concerning the inspection of a
facility may be provided to a foreign government if--
``(i) the Secretary reasonably believes, or
the written agreement described in paragraph (2)
establishes, that the government has authority to
otherwise obtain such information; and
``(ii) the written agreement executed under
paragraph (2) limits the recipient's use of the
information to the recipient's civil regulatory
purposes.
``(B) Information not described in subparagraph (A)
may be provided as part of an investigation, or to alert
the foreign government to the potential need for an
investigation, if the Secretary has reasonable grounds
to believe that a drug has a reasonable probability of
causing serious adverse health consequences or death to
humans or animals.
``(4) Effect of subsection.--Nothing in this subsection
affects the ability of the Secretary to enter into any written
agreement authorized by other provisions of law to share
confidential information.''.
SEC. 711. ENHANCING THE SAFETY AND QUALITY OF THE DRUG SUPPLY.
Section 501 (21 U.S.C. 351) is amended by adding at the end the
following flush text:
``For <> purposes of paragraph (a)(2)(B), the term
`current good manufacturing practice' includes the implementation of
oversight and controls over the manufacture of drugs to ensure quality,
including managing the risk of and establishing the safety of raw
materials, materials used in the manufacturing of drugs, and finished
drug products.''.
[[Page 1072]]
SEC. 712. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.
Chapter VIII (21 U.S.C. 381 et seq.) is amended by adding at the end
the following:
``SEC. 809. <> RECOGNITION OF FOREIGN
GOVERNMENT INSPECTIONS.
``(a) Inspection.--The Secretary--
``(1) may enter into arrangements and agreements with a
foreign government or an agency of a foreign government to
recognize the inspection of foreign establishments registered
under section 510(i) in order to facilitate risk-based
inspections in accordance with the schedule established in
section 510(h)(3);
``(2) may enter into arrangements and agreements with a
foreign government or an agency of a foreign government under
this section only with a foreign government or an agency of a
foreign government that the Secretary has determined as having
the capability of conduction inspections that meet the
applicable requirements of this Act; and
``(3) <> shall perform such reviews
and audits of drug safety programs, systems, and standards of a
foreign government or agency for the foreign government as the
Secretary deems necessary to determine that the foreign
government or agency of the foreign government is capable of
conducting inspections that meet the applicable requirements of
this Act.
``(b) Results of Inspection.--The results of inspections performed
by a foreign government or an agency of a foreign government under this
section may be used as--
``(1) evidence of compliance with section 501(a)(2)(B) or
section 801(r); and
``(2) for any other purposes as determined appropriate by
the Secretary.''.
SEC. 713. STANDARDS FOR ADMISSION OF IMPORTED DRUGS.
Section 801 (21 U.S.C. 381) is amended--
(1) in subsection (o), by striking ``drug or''; and
(2) by adding at the end the following:
``(r)(1) The Secretary may require, pursuant to the regulations
promulgated under paragraph (4)(A), as a condition of granting admission
to a drug imported or offered for import into the United States, that
the importer electronically submit information demonstrating that the
drug complies with applicable requirements of this Act.
``(2) The information described under paragraph (1) may include--
``(A) information demonstrating the regulatory status of the
drug, such as the new drug application, abbreviated new drug
application, or investigational new drug or drug master file
number;
``(B) facility information, such as proof of registration
and the unique facility identifier;
``(C) indication of compliance with current good
manufacturing practice, testing results, certifications relating
to satisfactory inspections, and compliance with the country of
export regulations; and
``(D) any other information deemed necessary and appropriate
by the Secretary to assess compliance of the article being
offered for import.
[[Page 1073]]
``(3) Information requirements referred to in paragraph (2)(C) may,
at the discretion of the Secretary, be satisfied--
``(A) through representation by a foreign government, if an
inspection is conducted by a foreign government using standards
and practices as determined appropriate by the Secretary;
``(B) through representation by a foreign government or an
agency of a foreign government recognized under section 809; or
``(C) other appropriate documentation or evidence as
described by the Secretary.
``(4)(A) <> Not later than 18 months
after the date of enactment of the Food and Drug Administration Safety
and Innovation Act, the Secretary shall adopt final regulations
implementing this subsection. Such requirements shall be appropriate for
the type of import, such as whether the drug is for import into the
United States for use in preclinical research or in a clinical
investigation under an investigational new drug exemption under 505(i).
``(B) In promulgating the regulations under subparagraph (A), the
Secretary--
``(i) may, as appropriate, take into account differences
among importers and types of imports, and, based on the level of
risk posed by the imported drug, provide for expedited clearance
for those importers that volunteer to participate in partnership
programs for highly compliant companies and pass a review of
internal controls, including sourcing of foreign manufacturing
inputs, and plant inspections; and
``(ii) shall--
``(I) <> issue a notice of proposed
rulemaking that includes the proposed regulation;
``(II) <> provide a period of
not less than 60 days for comments on the proposed
regulation; and
``(III) <> publish the final
regulation not less than 30 days before the effective
date of the regulation.
``(C) Notwithstanding any other provision of law, the Secretary
shall promulgate regulations implementing this subsection only as
described in subparagraph (B).''.
SEC. 714. REGISTRATION OF COMMERCIAL IMPORTERS.
(a) Prohibitions.--Section 301 (21 U.S.C. 331) is amended by adding
at the end the following:
``(aaa) The failure to register in accordance with section
801(s).''.
(b) Registration.--Section 801 (21 U.S.C. 381), as amended by
section 713 of this Act, is further amended by adding at the end the
following:
``(s) Registration of Commercial Importers.--
``(1) Registration.--The Secretary shall require a
commercial importer of drugs--
``(A) to be registered with the Secretary in a form
and manner specified by the Secretary; and
``(B) subject to paragraph (4), to submit, at the
time of registration, a unique identifier for the
principal place of business for which the importer is
required to register under this subsection.
``(2) <> Regulations.--
``(A) In general.--The Secretary, in consultation
with the Secretary of Homeland Security acting through
U.S.
[[Page 1074]]
Customs and Border Protection, shall promulgate
regulations to establish good importer practices that
specify the measures an importer shall take to ensure
imported drugs are in compliance with the requirements
of this Act and the Public Health Service Act.
``(B) Procedure.--In promulgating a regulation under
subparagraph (A), the Secretary shall--
``(i) <> issue a notice of
proposed rulemaking that includes the proposed
regulation;
``(ii) <> provide a period
of not less than 60 days for comments on the
proposed regulation; and
``(iii) <> publish the
final regulation not less than 30 days before the
regulation's effective date.
``(C) Restrictions.--Notwithstanding any other
provision of Federal law, in implementing this
subsection, the Secretary shall only promulgate
regulations as described in subparagraph (B).
``(3) Discontinuance of registration.--The Secretary shall
discontinue the registration of any commercial importer of drugs
that fails to comply with the regulations promulgated under this
subsection.
``(4) Unique facility identifier.--The Secretary shall
specify the unique facility identifier system that shall be used
by registrants under paragraph (1). <> The
requirement to include a unique facility identifier in a
registration under paragraph (1) shall not apply until the date
that the identifier system is specified by the Secretary under
the preceding sentence.
``(5) <> Exemptions.--
The Secretary, by notice in the Federal Register, may establish
exemptions from the requirements of this subsection.''.
(c) Misbranding.--Section 502(o) (21 U.S.C. 352) is amended by
inserting ``if it is a drug and was imported or offered for import by a
commercial importer of drugs not duly registered under section 801(s),''
after ``not duly registered under section 510,''.
(d) <> Regulations.--
(1) In general.--Not later than 36 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services, in consultation with the Secretary of Homeland
Security acting through U.S. Customs and Border Protection,
shall promulgate the regulations required to carry out section
801(s) of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (b).
(2) Procedures for promulgating regulations.--
(A) In general.--In promulgating a regulation under
paragraph (1), the Secretary shall--
(i) <> issue a notice of
proposed rulemaking that includes the proposed
regulation;
(ii) <> provide a period
of not less than 60 days for comments on the
proposed regulation; and
(iii) <> publish the final
regulation not less than 30 days before the
regulation's effective date.
(B) Restrictions.--Notwithstanding any other
provision of Federal law, in implementing section 801(s)
of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (b), the Secretary shall promulgate
regulations only as described in subparagraph (A).
[[Page 1075]]
(3) <> Effective date.--In establishing
the effective date of the regulations under paragraph (1), the
Secretary of Health and Human Services shall, in consultation
with the Secretary of Homeland Security acting through U.S.
Customs and Border Protection, as determined appropriate by the
Secretary of Health and Human Services, provide a reasonable
period of time for an importer of a drug to comply with good
importer practices, taking into account differences among
importers and types of imports, including based on the level of
risk posed by the imported product.
SEC. 715. NOTIFICATION.
(a) Prohibited Acts.--Section 301 (21 U.S.C. 331), as amended by
section 714 of this Act, is further amended by adding at the end the
following:
``(bbb) The failure to notify the Secretary in violation of section
568.''.
(b) Notification.--Subchapter E of chapter V (21 U.S.C. 360bbb et
seq.) is amended by adding at the end the following:
``SEC. 568. <> NOTIFICATION.
``(a) Notification to Secretary.--With respect to a drug, the
Secretary may require notification to the Secretary by a regulated
person if the regulated person knows--
``(1) that the use of such drug in the United States may
result in serious injury or death;
``(2) of a significant loss or known theft of such drug
intended for use in the United States; or
``(3) that--
``(A) such drug has been or is being counterfeited;
and
``(B)(i) the counterfeit product is in commerce in
the United States or could be reasonably expected to be
introduced into commerce in the United States; or
``(ii) such drug has been or is being imported into
the United States or may reasonably be expected to be
offered for import into the United States.
``(b) Manner of Notification.--Notification under this section shall
be made in such manner and by such means as the Secretary may specify by
regulation or guidance.
``(c) Savings Clause.--Nothing in this section shall be construed as
limiting any other authority of the Secretary to require notifications
related to a drug under any other provision of this Act or the Public
Health Service Act.
``(d) Definition.--In this section, the term `regulated person'
means--
``(1) a person who is required to register under section 510
or 801(s);
``(2) a wholesale distributor of a drug product; or
``(3) any other person that distributes drugs except a
person that distributes drugs exclusively for retail sale.''.
SEC. 716. PROTECTION AGAINST INTENTIONAL ADULTERATION.
Section 303(b) (21 U.S.C. 333(b)) is amended by adding at the end
the following:
``(7) Notwithstanding subsection (a)(2), any person that knowingly
and intentionally adulterates a drug such that the drug is adulterated
under subsection (a)(1), (b), (c), or (d) of section 501 and has a
reasonable probability of causing serious adverse health
[[Page 1076]]
consequences or death to humans or animals shall be imprisoned for not
more than 20 years or fined not more than $1,000,000, or both.''.
SEC. 717. PENALTIES FOR COUNTERFEITING DRUGS.
(a) Counterfeit Drug Penalty Enhancement.--
(1) Offense.--Section 2320(a) of title 18, United States
Code, is amended--
(A) by striking ``or'' at the end of paragraph (2);
(B) by inserting ``or'' at the end of paragraph (3);
(C) by inserting after paragraph (3) the following:
``(4) traffics in a counterfeit drug,''; and
(D) by striking ``through (3)'' and inserting
``through (4)''.
(2) Penalties.--Section 2320(b)(3) of title 18, United
States Code, is amended--
(A) in the heading, by inserting ``and counterfeit
drugs'' after ``services''; and
(B) by inserting ``or counterfeit drug'' after
``service''.
(3) Definition.--Section 2320(f) of title 18, United States
Code, is amended--
(A) by striking ``and'' at the end of paragraph (4);
(B) by striking the period at the end of paragraph
(5) and inserting ``; and''; and
(C) by adding at the end the following:
``(6) the term `counterfeit drug' means a drug, as defined
by section 201 of the Federal Food, Drug, and Cosmetic Act, that
uses a counterfeit mark on or in connection with the drug.''.
(4) <> Priority given to certain
investigations and prosecutions.--The Attorney General shall
give increased priority to efforts to investigate and prosecute
offenses under section 2320 of title 18, United States Code,
that involve counterfeit drugs.
(b) <> Sentencing Commission Directive.--
(1) <> Directive to sentencing
commission.--Pursuant to its authority under section 994(p) of
title 28, United States Code, and in accordance with this
subsection, the United States Sentencing Commission shall review
and amend, if appropriate, its guidelines and its policy
statements applicable to persons convicted of an offense
described in section 2320(a)(4) of title 18, United States Code,
as amended by subsection (a), in order to reflect the intent of
Congress that such penalties be increased in comparison to those
currently provided by the guidelines and policy statements.
(2) Requirements.--In carrying out this subsection, the
Commission shall--
(A) ensure that the sentencing guidelines and policy
statements reflect the intent of Congress that the
guidelines and policy statements reflect the serious
nature of the offenses described in paragraph (1) and
the need for an effective deterrent and appropriate
punishment to prevent such offenses;
(B) consider the extent to which the guidelines may
or may not appropriately account for the potential and
actual harm to the public resulting from the offense;
[[Page 1077]]
(C) assure reasonable consistency with other
relevant directives and with other sentencing
guidelines;
(D) account for any additional aggravating or
mitigating circumstances that might justify exceptions
to the generally applicable sentencing ranges;
(E) make any necessary conforming changes to the
sentencing guidelines; and
(F) assure that the guidelines adequately meet the
purposes of sentencing as set forth in section
3553(a)(2) of title 18, United States Code.
SEC. 718. EXTRATERRITORIAL JURISDICTION.
Chapter III (21 U.S.C. 331 et seq.) is amended by adding at the end
the following:
``SEC. 311. <> EXTRATERRITORIAL JURISDICTION.
``There is extraterritorial jurisdiction over any violation of this
Act relating to any article regulated under this Act if such article was
intended for import into the United States or if any act in furtherance
of the violation was committed in the United States.''.
TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW
SEC. 801. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.
(a) In General.--Chapter V (21 U.S.C. 351 et seq.) is amended by
inserting after section 505D the following:
``SEC. 505E. <> EXTENSION OF EXCLUSIVITY
PERIOD FOR NEW QUALIFIED INFECTIOUS
DISEASE PRODUCTS.
``(a) Extension.--If the Secretary approves an application pursuant
to section 505 for a drug that has been designated as a qualified
infectious disease product under subsection (d), the 4- and 5-year
periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of
section 505, the 3-year periods described in clauses (iii) and (iv) of
subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F)
of section 505, or the 7-year period described in section 527, as
applicable, shall be extended by 5 years.
``(b) Relation to Pediatric Exclusivity.--Any extension under
subsection (a) of a period shall be in addition to any extension of the
period under section 505A with respect to the drug.
``(c) Limitations.--Subsection (a) does not apply to the approval
of--
``(1) a supplement to an application under section 505(b)
for any qualified infectious disease product for which an
extension described in subsection (a) is in effect or has
expired;
``(2) a subsequent application filed with respect to a
product approved under section 505 for a change that results in
a new indication, route of administration, dosing schedule,
dosage form, delivery system, delivery device, or strength; or
``(3) a product that does not meet the definition of a
qualified infectious disease product under subsection (g) based
upon its approved uses.
``(d) Designation.--
``(1) In general.--The manufacturer or sponsor of a drug may
request the Secretary to designate a drug as a qualified
[[Page 1078]]
infectious disease product at any time before the submission of
an application under section 505(b) for such
drug. <> The Secretary shall,
not later than 60 days after the submission of such a request,
determine whether the drug is a qualified infectious disease
product.
``(2) Limitation.--Except as provided in paragraph (3), a
designation under this subsection shall not be withdrawn for any
reason, including modifications to the list of qualifying
pathogens under subsection (f)(2)(C).
``(3) Revocation of designation.--The Secretary may revoke a
designation of a drug as a qualified infectious disease product
if the Secretary finds that the request for such designation
contained an untrue statement of material fact.
``(e) <> Regulations.--
``(1) In general.--Not later than 2 years after the date of
enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall adopt final regulations
implementing this section, including developing the list of
qualifying pathogens described in subsection (f).
``(2) Procedure.--In promulgating a regulation implementing
this section, the Secretary shall--
``(A) <> issue a notice of proposed
rulemaking that includes the proposed regulation;
``(B) <> provide a period of not
less than 60 days for comments on the proposed
regulation; and
``(C) <> publish the final
regulation not less than 30 days before the effective
date of the regulation.
``(3) Restrictions.--Notwithstanding any other provision of
law, the Secretary shall promulgate regulations implementing
this section only as described in paragraph (2), except that the
Secretary may issue interim guidance for sponsors seeking
designation under subsection (d) prior to the promulgation of
such regulations.
``(4) Designation prior to regulations.--The Secretary shall
designate drugs as qualified infectious disease products under
subsection (d) prior to the promulgation of regulations under
this subsection, if such drugs meet the definition of a
qualified infectious disease product described in subsection
(g).
``(f) Qualifying Pathogen.--
``(1) Definition.--In this section, the term `qualifying
pathogen' means a pathogen identified and listed by the
Secretary under paragraph (2) that has the potential to pose a
serious threat to public health, such as--
``(A) resistant gram positive pathogens, including
methicillin-resistant Staphylococcus aureus, 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.
[[Page 1079]]
``(B) Considerations.--In establishing and
maintaining the list of pathogens described under this
section, the Secretary shall--
``(i) consider--
``(I) the impact on the public
health due to drug-resistant organisms
in humans;
``(II) the rate of growth of drug-
resistant organisms in humans;
``(III) the increase in resistance
rates in humans; and
``(IV) the morbidity and mortality
in humans; and
``(ii) <> consult with
experts in infectious diseases and antibiotic
resistance, including the Centers for Disease
Control and Prevention, the Food and Drug
Administration, medical professionals, and the
clinical research community.
``(C) <> Review.--Every 5
years, or more often as needed, the Secretary shall
review, provide modifications to, and publish the list
of qualifying pathogens under subparagraph (A) and shall
by regulation revise the list as necessary, in
accordance with subsection (e).
``(g) <> Qualified Infectious Disease Product.--
The term `qualified infectious disease product' means an antibacterial
or antifungal drug for human use intended to treat serious or 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.
[[Page 1080]]
SEC. 804. <> CLINICAL TRIALS.
(a) Review and Revision of Guidance Documents.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall review
and, as appropriate, revise not fewer than 3 guidance documents
per year, which shall include--
(A) reviewing the guidance documents of the Food and
Drug Administration for the conduct of clinical trials
with respect to antibacterial and antifungal drugs; and
(B) as appropriate, revising such guidance documents
to reflect developments in scientific and medical
information and technology and to ensure clarity
regarding the procedures and requirements for approval
of antibacterial and antifungal drugs under chapter V of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351
et seq.).
(2) Issues for review.--At a minimum, the review under
paragraph (1) shall address the appropriate animal models of
infection, in vitro techniques, valid microbiological surrogate
markers, the use of noninferiority versus superiority trials,
trial enrollment, data requirements, and appropriate delta
values for noninferiority trials.
(3) Rule of construction.--Except to the extent to which the
Secretary makes revisions under paragraph (1)(B), nothing in
this section shall be construed to repeal or otherwise effect
the guidance documents of the Food and Drug Administration.
(b) Recommendations for Investigations.--
(1) Request.--The sponsor of a drug intended to be
designated as a qualified infectious disease product may request
that the Secretary provide written recommendations for
nonclinical and clinical investigations which the Secretary
believes may be necessary to be conducted with the drug before
such drug may be approved under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) for use in treating,
detecting, preventing, or identifying a qualifying pathogen, as
defined in section 505E of such Act.
(2) Recommendations.--If the Secretary has reason to believe
that a drug for which a request is made under this subsection is
a qualified infectious disease product, the Secretary shall
provide the person making the request written recommendations
for the nonclinical and clinical investigations which the
Secretary believes, on the basis of information available to the
Secretary at the time of the request, would be necessary for
approval under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) of such drug for the use described
in paragraph (1).
(c) <> Qualified Infectious Disease Product.--For
purposes of this section, the term ``qualified infectious disease
product'' has the meaning given such term in section 505E(g) of the
Federal Food, Drug, and Cosmetic Act, as added by section 801 of this
Act.
SEC. 805. REASSESSMENT OF QUALIFIED INFECTIOUS DISEASE PRODUCT
INCENTIVES IN 5 YEARS.
(a) <> In General.--Not later than 5 years after the
date of enactment of this Act, the Secretary of Health and Human
Services shall, in consultation with the Food and Drug Administration,
the Centers for Disease Control and Prevention, and other appropriate
[[Page 1081]]
agencies, submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report that contains the following:
(1)(A) The number of initial designations of drugs as
qualified infectious disease products under section 505E of the
Federal Food, Drug, and Cosmetic Act.
(B) The number of qualified infectious disease products
approved under such section 505E.
(C) Whether such products address the need for antibacterial
and antifungal drugs to treat serious and life-threatening
infections.
(D) A list of qualified infectious disease products with
information on the types of exclusivity granted for each
product, consistent with the information published under section
505(j)(7)(A)(iii) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)(7)(A)(iii)).
(E) The progress made regarding the review and revision of
the clinical trial guidance documents required under section 804
and the impact such review and revision has had on the review
and approval of qualified infectious disease products.
(F) The Federal contribution, if any, to funding of the
clinical trials for each qualified infectious disease product
for each phase.
(2) Recommendations--
(A) based on the information under paragraph (1) and
any other relevant data, on any changes that should be
made to the list of pathogens that are defined as
qualifying pathogens under section 505E(f)(2) of the
Federal Food, Drug, and Cosmetic Act, as added by
section 801 of this Act; and
(B) on whether any additional program (such as the
development of public-private collaborations to advance
antibacterial drug innovation) or changes to the
incentives under this subtitle may be needed to promote
the development of antibacterial drugs.
(3) An examination of--
(A) the adoption of programs to measure the use of
antibacterial drugs in health care settings; and
(B) the implementation and effectiveness of
antimicrobial stewardship protocols across all health
care settings.
(4) Any recommendations for ways to encourage further
development and establishment of stewardship programs.
(5) A description of the regulatory challenges and
impediments to clinical development, approval, and licensure of
qualified infectious disease products, and the steps the
Secretary has taken and will take to address such challenges and
ensure regulatory certainty and predictability with respect to
qualified infectious disease products.
(b) Definition.--For purposes of this section, the term ``qualified
infectious disease product'' has the meaning given such term in section
505E(g) of the Federal Food, Drug, and Cosmetic Act, as added by section
801 of this Act.
[[Page 1082]]
SEC. 806. <> GUIDANCE ON PATHOGEN-FOCUSED
ANTIBACTERIAL DRUG DEVELOPMENT.
(a) Draft Guidance.--Not later than June 30, 2013, in order to
facilitate the development of antibacterial drugs for serious or life-
threatening bacterial infections, particularly in areas of unmet need,
the Secretary of Health and Human Services shall publish draft guidance
that--
(1) specifies how preclinical and clinical data can be
utilized to inform an efficient and streamlined pathogen-focused
antibacterial drug development program that meets the approval
standards of the Food and Drug Administration; and
(2) provides advice on approaches for the development of
antibacterial drugs that target a more limited spectrum of
pathogens.
(b) <> Final Guidance.--Not later than
December 31, 2014, after notice and opportunity for public comment on
the draft guidance under subsection (a), the Secretary of Health and
Human Services shall publish final guidance consistent with this
section.
TITLE IX--DRUG APPROVAL AND PATIENT ACCESS
SEC. 901. ENHANCEMENT OF ACCELERATED PATIENT ACCESS TO NEW MEDICAL
TREATMENTS.
(a) <> Findings; Sense of Congress.--
(1) Findings.--Congress finds as follows:
(A) The Food and Drug Administration (referred to in
this section as the ``FDA'') serves a critical role in
helping to assure that new medicines are safe and
effective. Regulatory innovation is 1 element of the
Nation's strategy to address serious and life-
threatening diseases or conditions by promoting
investment in and development of innovative treatments
for unmet medical needs.
(B) During the 2 decades following the establishment
of the accelerated approval mechanism, advances in
medical sciences, including genomics, molecular biology,
and bioinformatics, have provided an unprecedented
understanding of the underlying biological mechanism and
pathogenesis of disease. A new generation of modern,
targeted medicines is under development to treat serious
and life-threatening diseases, some applying drug
development strategies based on biomarkers or
pharmacogenomics, predictive toxicology, clinical trial
enrichment techniques, and novel clinical trial designs,
such as adaptive clinical trials.
(C) As a result of these remarkable scientific and
medical advances, the FDA should be encouraged to
implement more broadly effective processes for the
expedited development and review of innovative new
medicines intended to address unmet medical needs for
serious or life-threatening diseases or conditions,
including those for rare diseases or conditions, using a
broad range of surrogate or clinical endpoints and
modern scientific tools earlier in the drug development
cycle when appropriate. This may result in fewer,
smaller, or shorter clinical trials for the intended
patient population or targeted subpopulation
[[Page 1083]]
without compromising or altering the high standards of
the FDA for the approval of drugs.
(D) Patients benefit from expedited access to safe
and effective innovative therapies to treat unmet
medical needs for serious or life-threatening diseases
or conditions.
(E) For these reasons, the statutory authority in
effect on the day before the date of enactment of this
Act governing expedited approval of drugs for serious or
life-threatening diseases or conditions should be
amended in order to enhance the authority of the FDA to
consider appropriate scientific data, methods, and
tools, and to expedite development and access to novel
treatments for patients with a broad range of serious or
life-threatening diseases or conditions.
(2) Sense of congress.--It is the sense of Congress that the
Food and Drug Administration should apply the accelerated
approval and fast track provisions set forth in section 506 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356), as
amended by this section, to help expedite the development and
availability to patients of treatments for serious or 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 condition,
and it demonstrates the potential to address unmet medical needs
for such a disease or condition. (In this section, such a drug
is referred to as a `fast track product'.)
``(2) Request for designation.--The sponsor of a new drug
may request the Secretary to designate the drug as a fast track
product. A request for the designation may be made concurrently
with, or at any time after, submission of an application for the
investigation of the drug under section 505(i) or section
351(a)(3) of the Public Health Service Act.
``(3) <> Designation.--
Within 60 calendar days after the receipt of a request under
paragraph (2), the Secretary shall determine whether the drug
that is the subject of the request meets the criteria described
in paragraph (1). If the Secretary finds that the drug meets the
criteria, the Secretary shall designate the drug as a fast track
product and shall take such actions as are appropriate to
expedite the development and review of the application for
approval of such product.
``(b) Accelerated Approval of a Drug for a Serious or Life-
Threatening Disease or Condition, Including a Fast Track Product.--
``(1) In general.--
``(A) Accelerated approval.--The Secretary may
approve an application for approval of a product for a
[[Page 1084]]
serious or life-threatening disease or condition,
including a fast track product, under section 505(c) or
section 351(a) of the Public Health Service Act upon a
determination that the product has an effect on a
surrogate endpoint that is reasonably likely to predict
clinical benefit, or on a clinical endpoint that can be
measured earlier than irreversible morbidity or
mortality, that is reasonably likely to predict an
effect on irreversible morbidity or mortality or other
clinical benefit, taking into account the severity,
rarity, or prevalence of the condition and the
availability or lack of alternative treatments. The
approval described in the preceding sentence is referred
to in this section as `accelerated approval'.
``(B) Evidence.--The evidence to support that an
endpoint is reasonably likely to predict clinical
benefit under subparagraph (A) may include
epidemiological, pathophysiological, therapeutic,
pharmacologic, or other evidence developed using
biomarkers, for example, or other scientific methods or
tools.
``(2) Limitation.--Approval of a product under this
subsection may be subject to 1 or both of the following
requirements:
``(A) That the sponsor conduct appropriate
postapproval studies to verify and describe the
predicted effect on irreversible morbidity or mortality
or other clinical benefit.
``(B) <> That
the sponsor submit copies of all promotional materials
related to the product during the preapproval review
period and, following approval and for such period
thereafter as the Secretary determines to be
appropriate, at least 30 days prior to dissemination of
the materials.
``(3) <> Expedited withdrawal of
approval.--The Secretary may withdraw approval of a product
approved under accelerated approval using expedited procedures
(as prescribed by the Secretary in regulations which shall
include an opportunity for an informal hearing) if--
``(A) the sponsor fails to conduct any required
postapproval study of the drug with due diligence;
``(B) a study required to verify and describe the
predicted effect on irreversible morbidity or mortality
or other clinical benefit of the product fails to verify
and describe such effect or benefit;
``(C) other evidence demonstrates that the product
is not safe or effective under the conditions of use; or
``(D) the sponsor disseminates false or misleading
promotional materials with respect to the product.
``(c) Review of Incomplete Applications for Approval of a Fast Track
Product.--
``(1) <> In general.--If the Secretary
determines, after preliminary evaluation of clinical data
submitted by the sponsor, that a fast track product may be
effective, the Secretary shall evaluate for filing, and may
commence review of portions of, an application for the approval
of the product before the sponsor submits a complete
application. The Secretary shall commence such review only if
the applicant--
``(A) provides a schedule for submission of
information necessary to make the application complete;
and
[[Page 1085]]
``(B) pays any fee that may be required under
section 736.
``(2) <> Exception.--Any time period
for review of human drug applications that has been agreed to by
the Secretary and that has been set forth in goals identified in
letters of the Secretary (relating to the use of fees collected
under section 736 to expedite the drug development process and
the review of human drug applications) shall not apply to an
application submitted under paragraph (1) until the date on
which the application is complete.
``(d) Awareness Efforts.--The Secretary shall--
``(1) develop and disseminate to physicians, patient
organizations, pharmaceutical and biotechnology companies, and
other appropriate persons a description of the provisions of
this section applicable to accelerated approval and fast track
products; and
``(2) establish a program to encourage the development of
surrogate and clinical endpoints, including biomarkers, and
other scientific methods and tools that can assist the Secretary
in determining whether the evidence submitted in an application
is reasonably likely to predict clinical benefit for serious or
life-threatening conditions for which significant unmet medical
needs exist.
``(e) Construction.--
``(1) Purpose.--The amendments made by the Food and Drug
Administration Safety and Innovation Act to this section are
intended to encourage the Secretary to utilize innovative and
flexible approaches to the assessment of products under
accelerated approval for treatments for patients with serious or
life-threatening diseases or conditions and unmet medical needs.
``(2) Construction.--Nothing in this section shall be
construed to alter the standards of evidence under subsection
(c) or (d) of section 505 (including the substantial evidence
standard in section 505(d)) of this Act or under section 351(a)
of the Public Health Service Act. Such sections and standards of
evidence apply to the review and approval of products under this
section, including whether a product is safe and effective.
Nothing in this section alters the ability of the Secretary to
rely on evidence that does not come from adequate and 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
subsection (b), for drugs designated for a rare disease or
condition under section 526 of such Act (21 U.S.C. 360bb) and
shall also consider any unique issues associated with very rare
diseases.
[[Page 1086]]
(2) <> Final guidance.--
Not later than 1 year after the issuance of draft guidance under
paragraph (1), and after an opportunity for public comment, the
Secretary shall--
(A) issue final guidance; and
(B) amend the regulations governing accelerated
approval in parts 314 and 601 of title 21, Code of
Federal Regulations, as necessary to conform such
regulations with the amendment made by subsection (b).
(3) Consideration.--In developing the guidance under
paragraphs (1) and (2)(A) and the amendments under paragraph
(2)(B), the Secretary shall consider how to incorporate novel
approaches to the review of surrogate endpoints based on
pathophysiologic and pharmacologic evidence in such guidance,
especially in instances where the low prevalence of a disease
renders the existence or collection of other types of data
unlikely or impractical.
(4) Conforming changes.--The Secretary shall issue, as
necessary, conforming amendments to the applicable regulations
under title 21, Code of Federal Regulations, governing
accelerated approval.
(5) No effect of inaction on requests.--The issuance (or
nonissuance) of guidance or conforming regulations implementing
the amendment made by subsection (b) shall not preclude the
review of, or action on, a request for designation or an
application for approval submitted pursuant to section 506 of
the Federal Food, Drug, and Cosmetic Act, as amended by
subsection (b).
(d) Independent Review.--The Secretary may, in conjunction with
other planned reviews, contract with an independent entity with
expertise in assessing the quality and efficiency of biopharmaceutical
development and regulatory review programs to evaluate the Food and Drug
Administration's application of the processes described in section 506
of the Federal Food, Drug, and Cosmetic Act, as amended by subsection
(b), and the impact of such processes on the development and timely
availability of innovative treatments for patients suffering from
serious or life-threatening conditions. Any such evaluation shall
include consultation with regulated industries, patient advocacy and
disease research foundations, and relevant academic medical centers.
SEC. 902. BREAKTHROUGH THERAPIES.
(a) In General.--Section 506 (21 U.S.C. 356), as amended by section
901 of this Act, is further amended--
(1) by redesignating subsections (a) through (c) as
subsections (b) through (d), respectively;
(2) by redesignating subsection (d) as subsection (f);
(3) by inserting before subsection (b), as so redesignated,
the following:
``(a) Designation of a Drug as a Breakthrough Therapy.--
``(1) In general.--The Secretary shall, at the request of
the sponsor of a drug, expedite the development and review of
such drug if the drug is intended, alone or in combination with
1 or more other drugs, to treat a serious or life-threatening
disease or condition and preliminary clinical evidence indicates
that the drug may demonstrate substantial improvement over
existing therapies on 1 or more clinically significant
endpoints, such as substantial treatment effects observed early
in clinical
[[Page 1087]]
development. (In this section, such a drug is referred to as a
`breakthrough therapy'.)
``(2) Request for designation.--The sponsor of a drug may
request the Secretary to designate the drug as a breakthrough
therapy. A request for the designation may be made concurrently
with, or at any time after, the submission of an application for
the investigation of the drug under section 505(i) or section
351(a)(3) of the Public Health Service Act.
``(3) Designation.--
``(A) <> In
general.--Not later than 60 calendar days after the
receipt of a request under paragraph (2), the Secretary
shall determine whether the drug that is the subject of
the request meets the criteria described in paragraph
(1). If the Secretary finds that the drug meets the
criteria, the Secretary shall designate the drug as a
breakthrough therapy and shall take such actions as are
appropriate to expedite the development and review of
the application for approval of such drug.
``(B) Actions.--The actions to expedite the
development and review of an application under
subparagraph (A) may include, as appropriate--
``(i) holding meetings with the sponsor and
the review team throughout the development of the
drug;
``(ii) providing timely advice to, and
interactive communication with, the sponsor
regarding the development of the drug to ensure
that the development program to gather the
nonclinical and clinical data necessary for
approval is as efficient as practicable;
``(iii) involving senior managers and
experienced review staff, as appropriate, in a
collaborative, cross-disciplinary review;
``(iv) assigning a cross-disciplinary project
lead for the Food and Drug Administration review
team to facilitate an efficient review of the
development program and to serve as a scientific
liaison between the review team and the sponsor;
and
``(v) taking steps to ensure that the design
of the clinical trials is as efficient as
practicable, when scientifically appropriate, such
as by minimizing the number of patients exposed to
a potentially less efficacious treatment.''; and
(4) in subsection (f)(1), as so redesignated, by striking
``applicable to accelerated approval'' and inserting
``applicable to breakthrough therapies, accelerated approval,
and''.
(b) <> Guidance; Amended Regulations.--
(1) <> In general.--
(A) 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.
[[Page 1088]]
(B) Amended regulations.--
(i) In general.--If the Secretary determines
that it is necessary to amend the regulations
under title 21, Code of Federal Regulations in
order to implement the amendments made by this
section to section 506(a) of the Federal Food,
Drug, and Cosmetic Act, the Secretary shall amend
such regulations not later than 2 years after the
date of enactment of this Act.
(ii) Procedure.--In amending regulations under
clause (i), the Secretary shall--
(I) <> issue a notice
of proposed rulemaking that includes the
proposed regulation;
(II) <> provide
a period of not less than 60 days for
comments on the proposed regulation; and
(III) <> publish
the final regulation not less than 30
days before the effective date of the
regulation.
(iii) Restrictions.--Notwithstanding any other
provision of law, the Secretary shall promulgate
regulations implementing the amendments made by
this section only as described in clause (ii).
(2) Requirements.--Guidance issued under this section
shall--
(A) specify the process and criteria by which the
Secretary makes a designation under section 506(a)(3) of
the Federal Food, Drug, and Cosmetic Act; and
(B) specify the actions the Secretary shall take to
expedite the development and review of a breakthrough
therapy pursuant to such designation under such section
506(a)(3), including updating good review management
practices to reflect breakthrough therapies.
(c) Conforming Amendments.--Section 506B(e) (21 U.S.C. 356b) is
amended by striking ``section 506(b)(2)(A)'' each place such term
appears and inserting ``section 506(c)(2)(A)''.
SEC. 903. CONSULTATION WITH EXTERNAL EXPERTS ON RARE DISEASES,
TARGETED THERAPIES, AND GENETIC TARGETING
OF TREATMENTS.
Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as amended by
section 715 of this Act, is further amended by adding at the end the
following:
``SEC. 569. <> CONSULTATION WITH EXTERNAL
EXPERTS ON RARE DISEASES, TARGETED
THERAPIES, AND GENETIC TARGETING OF
TREATMENTS.
``(a) <> In General.--For the purpose of
promoting the efficiency of and informing the review by the Food and
Drug Administration of new drugs and biological products for rare
diseases and drugs and biological products that are genetically
targeted, the following shall apply:
``(1) Consultation with stakeholders.--Consistent with
sections X.C and IX.E.4 of the PDUFA Reauthorization Performance
Goals and Procedures Fiscal Years 2013 through 2017, as
referenced in the letters described in section 101(b) of the
Prescription Drug User Fee Amendments of 2012, the Secretary
shall ensure that opportunities exist, at a time the Secretary
determines appropriate, for consultations with stakeholders on
the topics described in subsection (b).
``(2) Consultation with external experts.--
[[Page 1089]]
``(A) <> In general.--The Secretary
shall develop and maintain a list of external experts
who, because of their special expertise, are qualified
to provide advice on rare disease issues, including
topics described in subsection (c). The Secretary may,
when appropriate to address a specific regulatory
question, consult such external experts on issues
related to the review of new drugs and biological
products for rare diseases and drugs and biological
products that are genetically targeted, including the
topics described in subsection (b), when such
consultation is necessary because the Secretary lacks
the specific scientific, medical, or technical expertise
necessary for the performance of the Secretary's
regulatory responsibilities and the necessary expertise
can be provided by the external experts.
``(B) External experts.--For purposes of
subparagraph (A), external experts are individuals who
possess scientific or medical training that the
Secretary lacks with respect to one or more rare
diseases.
``(b) Topics for Consultation.--Topics for consultation pursuant to
this section may include--
``(1) rare diseases;
``(2) the severity of rare diseases;
``(3) the unmet medical need associated with rare diseases;
``(4) the willingness and ability of individuals with a rare
disease to participate in clinical trials;
``(5) an assessment of the benefits and risks of therapies
to treat rare diseases;
``(6) the general design of clinical trials for rare disease
populations and subpopulations; and
``(7) the demographics and the clinical description of
patient populations.
``(c) Classification as Special Government Employees.--The external
experts who are consulted under this section may be considered special
government employees, as defined under section 202 of title 18, United
States Code.
``(d) Protection of Confidential Information and Trade Secrets.--
``(1) Rule of construction.--Nothing in this section shall
be construed to alter the protections offered by laws,
regulations, and policies governing disclosure of confidential
commercial or trade secret information, and any other
information exempt from disclosure pursuant to section 552(b) of
title 5, United States Code, as such provisions would be applied
to consultation with individuals and organizations prior to the
date of enactment of this section.
``(2) Consent required for disclosure.--The Secretary shall
not disclose confidential commercial or trade secret information
to an expert consulted under this section without the written
consent of the sponsor unless the expert is a special government
employee (as defined under section 202 of title 18, United
States Code) or the disclosure is otherwise authorized by law.
``(e) Other Consultation.--Nothing in this section shall be
construed to limit the ability of the Secretary to consult with
individuals and organizations as authorized prior to the date of
enactment of this section.
``(f) No Right or Obligation.--
[[Page 1090]]
``(1) No right to consultation.--Nothing in this section
shall be construed to create a legal right for a consultation on
any matter or require the Secretary to meet with any particular
expert or stakeholder.
``(2) No altering of goals.--Nothing in this section shall
be construed to alter agreed upon goals and procedures
identified in the letters described in section 101(b) of the
Prescription Drug User Fee Amendments of 2012.
``(3) No change to number of review cycles.--Nothing in this
section is intended to increase the number of review cycles as
in effect before the date of enactment of this section.
``(g) No Delay in Product Review.--
``(1) In general.--Prior to a consultation with an external
expert, as described in this section, relating to an
investigational new drug application under section 505(i), a new
drug application under section 505(b), or a biologics license
application under section 351 of the Public Health Service Act,
the Director of the Center for Drug Evaluation and Research or
the Director of the Center for Biologics Evaluation and Research
(or appropriate Division Director), as appropriate, shall
determine that--
``(A) such consultation will--
``(i) facilitate the Secretary's ability to
complete the Secretary's review; and
``(ii) address outstanding deficiencies in the
application; or
``(B) the sponsor authorized such consultation.
``(2) <> Limitation.--The requirements
of this subsection shall apply only in instances where the
consultation is undertaken solely under the authority of this
section. The requirements of this subsection shall not apply to
any consultation initiated under any other authority.''.
SEC. 904. <> ACCESSIBILITY OF INFORMATION
ON PRESCRIPTION DRUG CONTAINER LABELS BY
VISUALLY IMPAIRED AND BLIND CONSUMERS.
(a) Establishment of Working Group.--
(1) In general.--The Architectural and Transportation
Barriers Compliance Board (referred to in this section as the
``Access Board'') shall convene a stakeholder working group
(referred to in this section as the ``working group'') to
develop best practices on access to information on prescription
drug container labels for individuals who are blind or visually
impaired.
(2) Members.--The working group shall be comprised of
representatives of national organizations representing blind and
visually impaired individuals, national organizations
representing the elderly, and industry groups representing
stakeholders, including retail, mail-order, and independent
community pharmacies, who would be impacted by such best
practices. Representation within the working group shall be
divided equally between consumer and industry advocates.
(3) Best practices.--
(A) <> In general.--The working
group shall develop, not later than 1 year after the
date of the enactment of this Act, best practices for
pharmacies to ensure that
[[Page 1091]]
blind and visually impaired individuals have safe,
consistent, reliable, and independent access to the
information on prescription drug container labels.
(B) Public availability.--The best practices
developed under subparagraph (A) may be made publicly
available, including through the Internet Web sites of
the working group participant organizations, and through
other means, in a manner that provides access to
interested individuals, including individuals with
disabilities.
(C) Limitations.--The best practices developed under
subparagraph (A) shall not be construed as accessibility
guidelines or standards of the Access Board, and shall
not confer any rights or impose any obligations on
working group participants or other persons. Nothing in
this section shall be construed to limit or condition
any right, obligation, or remedy available under the
Americans with Disabilities Act of 1990 (42 U.S.C. 12101
et seq.) or any other Federal or State law requiring
effective communication, barrier removal, or
nondiscrimination on the basis of disability.
(4) Considerations.--In developing and issuing the best
practices under paragraph (3)(A), the working group shall
consider--
(A) the use of--
(i) Braille;
(ii) auditory means, such as--
(I) ``talking bottles'' that provide
audible container label information;
(II) digital voice recorders
attached to the prescription drug
container; and
(III) radio frequency identification
tags;
(iii) enhanced visual means, such as--
(I) large font labels or large font
``duplicate'' labels that are affixed or
matched to a prescription drug
container;
(II) high-contrast printing; and
(III) sans-serif font; and
(iv) other relevant alternatives as determined
by the working group;
(B) whether there are technical, financial,
manpower, or other factors unique to pharmacies with 20
or fewer retail locations which may pose significant
challenges to the adoption of the best practices; and
(C) such other factors as the working group
determines to be appropriate.
(5) Information campaign.--Upon completion of development of
the best practices under subsection (a)(3), the National Council
on Disability, in consultation with the working group, shall
conduct an informational and educational campaign designed to
inform individuals with disabilities, pharmacists, and the
public about such best practices.
(6) FACA waiver.--The Federal Advisory Committee Act (5
U.S.C. App.) shall not apply to the working group.
(b) GAO Study.--
(1) <> In general.--Beginning 18
months after the completion of the development of best practices
under subsection (a)(3)(A), the Comptroller General of the
United States shall conduct a review of the extent to which
pharmacies are utilizing such
[[Page 1092]]
best practices, and the extent to which barriers to accessible
information on prescription drug container labels for blind and
visually impaired individuals continue.
(2) Report.--Not later than September 30, 2016, the
Comptroller General of the United States shall submit to
Congress a report on the review conducted under paragraph (1).
Such report shall include recommendations about how best to
reduce the barriers experienced by blind and visually impaired
individuals to independently accessing information on
prescription drug container labels.
(c) Definitions.--In this section--
(1) the term ``pharmacy'' includes a pharmacy that receives
prescriptions and dispenses prescription drugs through an
Internet Web site or by mail;
(2) the term ``prescription drug'' means a drug subject to
section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(b)(1)); and
(3) the term ``prescription drug container label'' means the
label with the directions for use that is affixed to the
prescription drug container by the pharmacist and dispensed to
the consumer.
SEC. 905. RISK-BENEFIT FRAMEWORK.
Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end
the following: ``The Secretary shall implement a structured risk-benefit
assessment framework in the new drug approval process to facilitate the
balanced consideration of benefits and risks, a consistent and
systematic approach to the discussion and regulatory decisionmaking, and
the communication of the benefits and risks of new drugs. Nothing in the
preceding sentence shall alter the criteria for evaluating an
application for premarket approval of a drug.''.
SEC. 906. GRANTS AND CONTRACTS FOR THE DEVELOPMENT OF ORPHAN
DRUGS.
(a) Qualified Testing Definition.--Section 5(b)(1)(A)(ii) of the
Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A)(ii)) is amended by striking
``after the date such drug is designated under section 526 of such Act
and''.
(b) Authorization of Appropriations.--Section 5(c) of the Orphan
Drug Act (21 U.S.C. 360ee(c)) is amended to read as follows:
``(c) Authorization of Appropriations.--For grants and contracts
under subsection (a), there is authorized to be appropriated $30,000,000
for each of fiscal years 2013 through 2017.''.
SEC. 907. REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS IN
CLINICAL TRIALS AND DATA ANALYSIS IN
APPLICATIONS FOR DRUGS, BIOLOGICS, AND
DEVICES.
(a) Report.--
(1) <> In general.--Not later than 1
year after the date of enactment of this Act, the Secretary,
acting through the Commissioner, shall publish on the Internet
Web site of the Food and Drug Administration a report,
consistent with the regulations of the Food and Drug
Administration pertaining to the protection of sponsors'
confidential commercial information as of the date of enactment
of this Act, addressing the extent to which clinical trial
participation and the inclusion of safety and effectiveness data
by demographic subgroups
[[Page 1093]]
including sex, age, race, and ethnicity, is included in
applications submitted to the Food and Drug Administration, and
shall provide such publication to Congress.
(2) Contents of report.--The report described in paragraph
(1) shall contain the following:
(A) A description of existing tools to ensure that
data to support demographic analyses are submitted in
applications for drugs, biological products, and
devices, and that these analyses are conducted by
applicants consistent with applicable Food and Drug
Administration requirements and Guidance for Industry.
The report shall address how the Food and Drug
Administration makes available information about
differences in safety and effectiveness of medical
products according to demographic subgroups, such as
sex, age, racial, and ethnic subgroups, to health care
providers, researchers, and patients.
(B) An analysis of the extent to which demographic
data subset analyses on sex, age, race, and ethnicity is
presented in applications for new drug applications for
new molecular entities under section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355), in
biologics license applications under section 351 of the
Public Health Service Act (42 U.S.C. 262), and in
premarket approval applications under section 515 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e)
for products approved or licensed by the Food and Drug
Administration, consistent with applicable requirements
and Guidance for Industry, and consistent with the
regulations of the Food and Drug Administration
pertaining to the protection of sponsors' confidential
commercial information as of the date of enactment of
this Act.
(C) An analysis of the extent to which demographic
subgroups, including sex, age, racial, and ethnic
subgroups, are represented in clinical studies to
support applications for approved or licensed new
molecular entities, biological products, and devices.
(D) An analysis of the extent to which a summary of
product safety and effectiveness data by demographic
subgroups including sex, age, race, and ethnicity is
readily available to the public in a timely manner by
means of the product labeling or the Food and Drug
Administration's Internet Web site.
(b) Action Plan.--
(1) <> In general.--Not later than 1
year after the publication of the report described in subsection
(a), the Secretary, acting through the Commissioner, shall
publish an action plan on the Internet Web site of the Food and
Drug Administration, and provide such publication to Congress.
(2) Content of action plan.--The plan described in paragraph
(1) shall include--
(A) recommendations, as appropriate, to improve the
completeness and quality of analyses of data on
demographic subgroups in summaries of product safety and
effectiveness data and in labeling;
(B) recommendations, as appropriate, on the
inclusion of such data, or the lack of availability of
such data in labeling;
[[Page 1094]]
(C) recommendations, as appropriate, to otherwise
improve the public availability of such data to
patients, health care providers, and researchers; and
(D) a determination with respect to each
recommendation identified in subparagraphs (A) through
(C) that distinguishes between product types referenced
in subsection (a)(2)(B) insofar as the applicability of
each such recommendation to each type of product.
(c) Definitions.--In this section:
(1) The term ``Commissioner'' means the Commissioner of Food
and Drugs.
(2) The term ``device'' has the meaning given such term in
section 201(h) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321(h)).
(3) The term ``drug'' has the meaning given such term in
section 201(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321(g)).
(4) The term ``biological product'' has the meaning given
such term in section 351(i) of the Public Health Service Act (42
U.S.C. 262(i)).
(5) The term ``Secretary'' means the Secretary of Health and
Human Services.
SEC. 908. RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER INCENTIVE
PROGRAM.
Subchapter B of chapter V (21 U.S.C. 360aa et seq.) is amended by
adding at the end the following:
``SEC. 529. <> PRIORITY REVIEW TO ENCOURAGE
TREATMENTS FOR RARE PEDIATRIC DISEASES.
``(a) Definitions.--In this section:
``(1) <> Priority review.--The term
`priority review', with respect to a human drug application as
defined in section 735(1), means review and action by the
Secretary on such application not later than 6 months after
receipt by the Secretary of such application, as described in
the Manual of Policies and Procedures of the Food and Drug
Administration and goals identified in the letters described in
section 101(b) of the Prescription Drug User Fee Amendments of
2012.
``(2) Priority review voucher.--The term `priority review
voucher' means a voucher issued by the Secretary to the sponsor
of a rare pediatric disease product application that entitles
the holder of such voucher to priority review of a single human
drug application submitted under section 505(b)(1) or section
351(a) of the Public Health Service Act after the date of
approval of the rare pediatric disease product application.
``(3) Rare pediatric disease.--The term `rare pediatric
disease' means a disease that meets each of the following
criteria:
``(A) The disease primarily affects individuals aged
from birth to 18 years, including age groups often
called neonates, infants, children, and adolescents.
``(B) The disease is a rare disease or condition,
within the meaning of section 526.
``(4) Rare pediatric disease product application.--The term
`rare pediatric disease product application' means a human drug
application, as defined in section 735(1), that--
``(A) is for a drug or biological product--
[[Page 1095]]
``(i) that is for the prevention or treatment
of a rare pediatric disease; and
``(ii) that contains no active ingredient
(including any ester or salt of the active
ingredient) that has been previously approved in
any other application under section 505(b)(1),
505(b)(2), or 505(j) of this Act or section 351(a)
or 351(k) of the Public Health Service Act;
``(B) is submitted under section 505(b)(1) of this
Act or section 351(a) of the Public Health Service Act;
``(C) the Secretary deems eligible for priority
review;
``(D) that relies on clinical data derived from
studies examining a pediatric population and dosages of
the drug intended for that population;
``(E) that does not seek approval for an adult
indication in the original rare pediatric disease
product application; and
``(F) is approved after the date of the enactment of
the Prescription Drug User Fee Amendments of 2012.
``(b) Priority Review Voucher.--
``(1) In general.--The Secretary shall award a priority
review voucher to the sponsor of a rare pediatric disease
product application upon approval by the Secretary of such rare
pediatric disease product application.
``(2) Transferability.--
``(A) In general.--The sponsor of a rare pediatric
disease product application that receives a priority
review voucher under this section may transfer
(including by sale) the entitlement to such voucher.
There is no limit on the number of times a priority
review voucher may be transferred before such voucher is
used.
``(B) <> Notification of
transfer.--Each person to whom a voucher is transferred
shall notify the Secretary of such change in ownership
of the voucher not later than 30 days after such
transfer.
``(3) <