[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 3187 Enrolled Bill (ENR)]
S.3187
One Hundred Twelfth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Tuesday,
the third day of January, two thousand and twelve
An Act
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user-fee programs for prescription drugs and medical devices, to
establish 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.
Sec. 403. Reauthorization; reporting requirements.
Sec. 404. Sunset dates.
Sec. 405. Effective date.
Sec. 406. Savings clause.
Sec. 407. Conforming amendment.
Sec. 408. Additional reporting requirements.
TITLE V--PEDIATRIC DRUGS AND DEVICES
Sec. 501. Permanence.
Sec. 502. Written requests.
Sec. 503. Communication with Pediatric Review Committee.
Sec. 504. Access to data.
Sec. 505. Ensuring the completion of pediatric studies.
Sec. 506. Pediatric study plans.
Sec. 507. Reauthorizations.
Sec. 508. Report.
Sec. 509. Technical amendments.
Sec. 510. Pediatric rare diseases.
Sec. 511. Staff of Office of Pediatric Therapeutics.
TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS
Sec. 601. Investigational device exemptions.
Sec. 602. Clarification of least burdensome standard.
Sec. 603. Agency documentation and review of significant decisions.
Sec. 604. Device modifications requiring premarket notification prior to
marketing.
Sec. 605. Program to improve the device recall system.
Sec. 606. Clinical holds on investigational device exemptions.
Sec. 607. Modification of de novo application process.
Sec. 608. Reclassification procedures.
Sec. 609. Harmonization of device premarket review, inspection, and
labeling symbols.
Sec. 610. Participation in international fora.
Sec. 611. Reauthorization of third-party review.
Sec. 612. Reauthorization of third-party inspection.
Sec. 613. Humanitarian device exemptions.
Sec. 614. Unique device identifier.
Sec. 615. Sentinel.
Sec. 616. Postmarket surveillance.
Sec. 617. Custom devices.
Sec. 618. Health information technology.
Sec. 619. Good guidance practices relating to devices.
Sec. 620. Pediatric device consortia.
TITLE VII--DRUG SUPPLY CHAIN
Sec. 701. Registration of domestic drug establishments.
Sec. 702. Registration of foreign establishments.
Sec. 703. Identification of drug excipient information with product
listing.
Sec. 704. Electronic system for registration and listing.
Sec. 705. Risk-based inspection frequency.
Sec. 706. Records for inspection.
Sec. 707. Prohibition against delaying, denying, limiting, or refusing
inspection.
Sec. 708. Destruction of adulterated, misbranded, or counterfeit drugs
offered for import.
Sec. 709. Administrative detention.
Sec. 710. Exchange of information.
Sec. 711. Enhancing the safety and quality of the drug supply.
Sec. 712. Recognition of foreign government inspections.
Sec. 713. Standards for admission of imported drugs.
Sec. 714. Registration of commercial importers.
Sec. 715. Notification.
Sec. 716. Protection against intentional adulteration.
Sec. 717. Penalties for counterfeiting drugs.
Sec. 718. Extraterritorial jurisdiction.
TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW
Sec. 801. Extension of exclusivity period for drugs.
Sec. 802. Priority review.
Sec. 803. Fast track product.
Sec. 804. Clinical trials.
Sec. 805. Reassessment of qualified infectious disease product
incentives in 5 years.
Sec. 806. Guidance on pathogen-focused antibacterial drug development.
TITLE IX--DRUG APPROVAL AND PATIENT ACCESS
Sec. 901. Enhancement of accelerated patient access to new medical
treatments.
Sec. 902. Breakthrough therapies.
Sec. 903. Consultation with external experts on rare diseases, targeted
therapies, and genetic targeting of treatments.
Sec. 904. Accessibility of information on prescription drug container
labels by visually impaired and blind consumers.
Sec. 905. Risk-benefit framework.
Sec. 906. Grants and Contracts for the Development of Orphan Drugs.
Sec. 907. Reporting of inclusion of demographic subgroups in clinical
trials and data analysis in applications for drugs, biologics,
and devices.
Sec. 908. Rare pediatric disease priority review voucher incentive
program.
TITLE X--DRUG SHORTAGES
Sec. 1001. Discontinuance or interruption in the production of life-
saving drugs.
Sec. 1002. Annual reporting on drug shortages.
Sec. 1003. Coordination; task force and strategic plan.
Sec. 1004. Drug shortage list.
Sec. 1005. Quotas applicable to drugs in shortage.
Sec. 1006. Attorney General report on drug shortages.
Sec. 1007. Hospital repackaging of drugs in shortage.
Sec. 1008. Study on drug shortages.
TITLE XI--OTHER PROVISIONS
Subtitle A--Reauthorizations
Sec. 1101. Reauthorization of provision relating to exclusivity of
certain drugs containing single enantiomers.
Sec. 1102. Reauthorization of the critical path public-private
partnerships.
Subtitle B--Medical Gas Product Regulation
Sec. 1111. Regulation of medical gases.
Sec. 1112. Changes to regulations.
Sec. 1113. Rules of construction.
Subtitle C--Miscellaneous Provisions
Sec. 1121. Guidance document regarding product promotion using the
Internet.
Sec. 1122. Combating prescription drug abuse.
Sec. 1123. Optimizing global clinical trials.
Sec. 1124. Advancing regulatory science to promote public health
innovation.
Sec. 1125. Information technology.
Sec. 1126. Nanotechnology.
Sec. 1127. Online pharmacy report to Congress.
Sec. 1128. Report on small businesses.
Sec. 1129. Protections for the commissioned corps of the public health
service act.
Sec. 1130. Compliance date for rule relating to sunscreen drug products
for over-the-counter human use.
Sec. 1131. Strategic integrated management plan.
Sec. 1132. Assessment and modification of REMS.
Sec. 1133. Extension of period for first applicant to obtain tentative
approval without forfeiting 180-day-exclusivity period.
Sec. 1134. Deadline for determination on certain petitions.
Sec. 1135. Final agency action relating to petitions and civil actions.
Sec. 1136. Electronic submission of applications.
Sec. 1137. Patient participation in medical product discussions.
Sec. 1138. Ensuring adequate information regarding pharmaceuticals for
all populations, particularly underrepresented subpopulations,
including racial subgroups.
Sec. 1139. Scheduling of hydrocodone.
Sec. 1140. Study on Drug Labeling by Electronic Means.
Sec. 1141. Recommendations on interoperability standards.
Sec. 1142. Conflicts of interest.
Sec. 1143. Notification of FDA intent to regulate laboratory-developed
tests.
Subtitle D--Synthetic Drugs
Sec. 1151. Short title.
Sec. 1152. Addition of synthetic drugs to schedule I of the Controlled
Substances Act.
Sec. 1153. Temporary scheduling to avoid imminent hazards to public
safety expansion.
(b) References in 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 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--
``(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 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 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;
``(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.
(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'';
(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
(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 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 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, 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 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--
``(i) to be used as a component of a drug; and
``(ii) to furnish pharmacological activity or other
direct effect in the diagnosis, cure, mitigation,
treatment, or prevention of disease, or to affect the
structure or any function of the human body; or
``(B) a substance intended for final crystallization,
purification, or salt formation, or any combination of those
activities, to become a substance or mixture described in
subparagraph (A).
``(3) The term `adjustment factor' means a factor applicable to
a fiscal year that is the Consumer Price Index for all urban
consumers (all items; United States city average) for October of
the preceding fiscal year divided by such Index for October 2011.
``(4) The term `affiliate' means a business entity that has a
relationship with a second business entity if, directly or
indirectly--
``(A) one business entity controls, or has the power to
control, the other business entity; or
``(B) a third party controls, or has power to control, both
of the business entities.
``(5)(A) The term `facility'--
``(i) means a business or other entity--
``(I) under one management, either direct or indirect;
and
``(II) at one geographic location or address engaged in
manufacturing or processing an active pharmaceutical
ingredient or a finished dosage form; and
``(ii) does not include a business or other entity whose
only manufacturing or processing activities are one or more of
the following: repackaging, relabeling, or testing.
``(B) For purposes of subparagraph (A), separate buildings
within close proximity are considered to be at one geographic
location or address if the activities in them are--
``(i) closely related to the same business enterprise;
``(ii) under the supervision of the same local management;
and
``(iii) capable of being inspected by the Food and Drug
Administration during a single inspection.
``(C) If a business or other entity would meet the definition
of a facility under this paragraph but for being under multiple
management, the business or other entity is deemed to constitute
multiple facilities, one per management entity, for purposes of
this paragraph.
``(6) The term `finished dosage form' means--
``(A) a drug product in the form in which it will be
administered to a patient, such as a tablet, capsule, solution,
or topical application;
``(B) a drug product in a form in which reconstitution is
necessary prior to administration to a patient, such as oral
suspensions or lyophilized powders; or
``(C) any combination of an active pharmaceutical
ingredient with another component of a drug product for
purposes of production of a drug product described in
subparagraph (A) or (B).
``(7) The term `generic drug submission' means an abbreviated
new drug application, an amendment to an abbreviated new drug
application, or a prior approval supplement to an abbreviated new
drug application.
``(8) The term `human generic drug activities' means the
following activities of the Secretary associated with generic drugs
and inspection of facilities associated with generic drugs:
``(A) The activities necessary for the review of generic
drug submissions, including review of drug master files
referenced in such submissions.
``(B) The issuance of--
``(i) approval letters which approve abbreviated new
drug applications or supplements to such applications; or
``(ii) complete response letters which set forth in
detail the specific deficiencies in such applications and,
where appropriate, the actions necessary to place such
applications in condition for approval.
``(C) The issuance of letters related to Type II active
pharmaceutical drug master files which--
``(i) set forth in detail the specific deficiencies in
such submissions, and where appropriate, the actions
necessary to resolve those deficiencies; or
``(ii) document that no deficiencies need to be
addressed.
``(D) Inspections related to generic drugs.
``(E) Monitoring of research conducted in connection with
the review of generic drug submissions and drug master files.
``(F) Postmarket safety activities with respect to drugs
approved under abbreviated new drug applications or
supplements, including the following activities:
``(i) Collecting, developing, and reviewing safety
information on approved drugs, including adverse event
reports.
``(ii) Developing and using improved adverse-event
data-collection systems, including information technology
systems.
``(iii) Developing and using improved analytical tools
to assess potential safety problems, including access to
external data bases.
``(iv) Implementing and enforcing section 505(o)
(relating to postapproval studies and clinical trials and
labeling changes) and section 505(p) (relating to risk
evaluation and mitigation strategies) insofar as those
activities relate to abbreviated new drug applications.
``(v) Carrying out section 505(k)(5) (relating to
adverse-event reports and postmarket safety activities).
``(G) Regulatory science activities related to generic
drugs.
``(9) The term `positron emission tomography drug' has the
meaning given to the term `compounded positron emission tomography
drug' in section 201(ii), except that paragraph (1)(B) of such
section shall not apply.
``(10) The term `prior approval supplement' means a request to
the Secretary to approve a change in the drug substance, drug
product, production process, quality controls, equipment, or
facilities covered by an approved abbreviated new drug application
when that change has a substantial potential to have an adverse
effect on the identity, strength, quality, purity, or potency of
the drug product as these factors may relate to the safety or
effectiveness of the drug product.
``(11) The term `resources allocated for human generic drug
activities' means the expenses for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related to such
officers and employees and to contracts with such contractors;
``(B) management of information, and the acquisition,
maintenance, and repair of computer resources;
``(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other necessary
materials and supplies; and
``(D) collecting fees under subsection (a) and accounting
for resources allocated for the review of abbreviated new drug
applications and supplements and inspection related to generic
drugs.
``(12) The term `Type II active pharmaceutical ingredient drug
master file' means a submission of information to the Secretary by
a person that intends to authorize the Food and Drug Administration
to reference the information to support approval of a generic drug
submission without the submitter having to disclose the information
to the generic drug submission applicant.
``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 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.
``(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 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
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).
``(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 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
``(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 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 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.
``(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 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 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).
``(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 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 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;
``(ii) an application filed under section 351(k) of the
Public Health Service Act that cites as the reference product a
bovine blood product for topical application licensed before
September 1, 1992, or a large volume parenteral drug product
approved before such date;
``(iii) an application filed under section 351(k) of the
Public Health Service Act with respect to--
``(I) whole blood or a blood component for transfusion;
``(II) an allergenic extract product;
``(III) an in vitro diagnostic biological product; or
``(IV) a biological product for further manufacturing
use only; or
``(iv) an application for licensure under section 351(k) of
the Public Health Service Act that is submitted by a State or
Federal Government entity for a product that is not distributed
commercially.
``(5) The term `biosimilar biological product development
meeting' means any meeting, other than a biosimilar initial
advisory meeting, regarding the content of a development program,
including a proposed design for, or data from, a study intended to
support a biosimilar biological product application.
``(6) The term `biosimilar biological product development
program' means the program under this part for expediting the
process for the review of submissions in connection with biosimilar
biological product development.
``(7)(A) The term `biosimilar biological product establishment'
means a foreign or domestic place of business--
``(i) that is at one general physical location consisting
of one or more buildings, all of which are within 5 miles of
each other; and
``(ii) at which one or more biosimilar biological products
are manufactured in final dosage form.
``(B) For purposes of subparagraph (A)(ii), the term
`manufactured' does not include packaging.
``(8) The term `biosimilar initial advisory meeting'--
``(A) means a meeting, if requested, that is limited to--
``(i) a general discussion regarding whether licensure
under section 351(k) of the Public Health Service Act may
be feasible for a particular product; and
``(ii) if so, general advice on the expected content of
the development program; and
``(B) does not include any meeting that involves
substantive review of summary data or full study reports.
``(9) The term `costs of resources allocated for the process
for the review of biosimilar biological product applications' means
the expenses in connection with the process for the review of
biosimilar biological product applications for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related to such
officers employees and committees and to contracts with such
contractors;
``(B) management of information, and the acquisition,
maintenance, and repair of computer resources;
``(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other necessary
materials and supplies; and
``(D) collecting fees under section 744H and accounting for
resources allocated for the review of submissions in connection
with biosimilar biological product development, biosimilar
biological product applications, and supplements.
``(10) The term `final dosage form' means, with respect to a
biosimilar biological product, a finished dosage form which is
approved for administration to a patient without substantial
further manufacturing (such as lyophilized products before
reconstitution).
``(11) The term `financial hold'--
``(A) means an order issued by the Secretary to prohibit
the sponsor of a clinical investigation from continuing the
investigation if the Secretary determines that the
investigation is intended to support a biosimilar biological
product application and the sponsor has failed to pay any fee
for the product required under subparagraph (A), (B), or (D) of
section 744H(a)(1); and
``(B) does not mean that any of the bases for a `clinical
hold' under section 505(i)(3) have been determined by the
Secretary to exist concerning the investigation.
``(12) The term `person' includes an affiliate of such person.
``(13) The term `process for the review of biosimilar
biological product applications' means the following activities of
the Secretary with respect to the review of submissions in
connection with biosimilar biological product development,
biosimilar biological product applications, and supplements:
``(A) The activities necessary for the review of
submissions in connection with biosimilar biological product
development, biosimilar biological product applications, and
supplements.
``(B) Actions related to submissions in connection with
biosimilar biological product development, the issuance of
action letters which approve biosimilar biological product
applications or which set forth in detail the specific
deficiencies in such applications, and where appropriate, the
actions necessary to place such applications in condition for
approval.
``(C) The inspection of biosimilar biological product
establishments and other facilities undertaken as part of the
Secretary's review of pending biosimilar biological product
applications and supplements.
``(D) Activities necessary for the release of lots of
biosimilar biological products under section 351(k) of the
Public Health Service Act.
``(E) Monitoring of research conducted in connection with
the review of biosimilar biological product applications.
``(F) Postmarket safety activities with respect to
biologics approved under biosimilar biological product
applications or supplements, including the following
activities:
``(i) Collecting, developing, and reviewing safety
information on biosimilar biological products, including
adverse-event reports.
``(ii) Developing and using improved adverse-event
data-collection systems, including information technology
systems.
``(iii) Developing and using improved analytical tools
to assess potential safety problems, including access to
external data bases.
``(iv) Implementing and enforcing section 505(o)
(relating to postapproval studies and clinical trials and
labeling changes) and section 505(p) (relating to risk
evaluation and mitigation strategies).
``(v) Carrying out section 505(k)(5) (relating to
adverse-event reports and postmarket safety activities).
``(14) The term `supplement' means a request to the Secretary
to approve a change in a biosimilar biological product application
which has been approved, including a supplement requesting that the
Secretary determine that the biosimilar biological product meets
the standards for interchangeability described in section 351(k)(4)
of the Public Health Service Act.
``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 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 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
``(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) 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 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, 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 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 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 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.
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).
(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--
(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 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 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--
``(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,'';
(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 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
(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)--
(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)--
(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 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
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.--
``(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 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--
``(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 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--
``(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 under
subsection (b) (or a regulation promulgated under such
subsection prior to the date of enactment of the Food and Drug
Administration Safety and Innovation Act)'';
(B) in subsection (b)--
(i) in paragraph (1)--
(I) in the heading, by striking ``Regulation'' and
inserting ``Order''; and
(II) in the matter following subparagraph (B)--
(aa) by striking ``by regulation, promulgated
in accordance with this subsection'' and inserting
``by administrative order following publication of
a proposed order in the Federal Register, a meeting
of a device classification panel described in
section 513(b), and consideration of comments from
all affected stakeholders, including patients,
payors, and providers, notwithstanding subchapter
II of chapter 5 of title 5, United States Code'';
and
(bb) by adding at the end the following:
``Authority to issue such administrative order
shall not be delegated below the Director of the
Center for Devices and Radiological Health, acting
in consultation with the Commissioner.'';
(ii) in paragraph (2)--
(I) by striking subparagraph (B); and
(II) in subparagraph (A)--
(aa) by striking ``(2)(A) A proceeding for the
promulgation of a regulation under paragraph (1)
respecting a device shall be initiated by the
publication in the Federal Register of a notice of
proposed rulemaking. Such notice shall contain--''
and inserting ``(2) A proposed order required under
paragraph (1) shall contain--'';
(bb) by redesignating clauses (i) through (iv)
as subparagraphs (A) through (D), respectively;
(cc) in subparagraph (A), as so redesignated,
by striking ``regulation'' and inserting ``order'';
and
(dd) in subparagraph (C), as so redesignated,
by striking ``regulation'' and inserting ``order'';
(iii) in paragraph (3)--
(I) by striking ``proposed regulation'' each place
such term appears and inserting ``proposed order'';
(II) by striking ``paragraph (2) and after'' and
inserting ``paragraph (2),'';
(III) by inserting ``and a meeting of a device
classification panel described in section 513(b),''
after ``such proposed regulation and findings,'';
(IV) by striking ``(A) promulgate such regulation''
and inserting ``(A) issue an administrative order under
paragraph (1)'';
(V) by striking ``paragraph (2)(A)(ii)'' and
inserting ``paragraph (2)(B)''; and
(VI) by striking ``promulgation of the regulation''
and inserting ``issuance of the administrative order'';
and
(iv) by striking paragraph (4); and
(C) in subsection (i)--
(i) in paragraph (2)--
(I) in the matter preceding subparagraph (A)--
(aa) by striking ``December 1, 1995'' and
inserting ``the date that is 2 years after the date
of enactment of the Food and Drug Administration
Safety and Innovation Act''; and
(bb) by striking ``publish a regulation in the
Federal Register'' and inserting ``issue an
administrative order following publication of a
proposed order in the Federal Register, a meeting
of a device classification panel described in
section 513(b), and consideration of comments from
all affected stakeholders, including patients,
payors, and providers, notwithstanding subchapter
II of chapter 5 of title 5, United States Code,'';
(II) in subparagraph (B), by striking ``final
regulation has been promulgated under section 515(b)''
and inserting ``administrative order has been issued
under subsection (b) (or no regulation has been
promulgated under such subsection prior to the date of
enactment of the Food and Drug Administration Safety
and Innovation Act)'';
(III) in the matter following subparagraph (B), by
striking ``regulation requires'' and inserting
``administrative order issued under this paragraph
requires''; and
(IV) by striking the third and fourth sentences;
and
(ii) in paragraph (3)--
(I) by striking ``regulation requiring'' each place
such term appears and inserting ``order requiring'';
and
(II) by striking ``promulgation of a section 515(b)
regulation'' and inserting ``issuance of an
administrative order under subsection (b)''.
(2) Technical and conforming 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 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.--The Secretary of Health and Human Services shall
annually post on the Internet Web site of the Food and Drug
Administration--
(1) the number and type of class I and class II devices
reclassified as class II or class III in the previous calendar year
under section 513(e)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360c(e)(1));
(2) the number and type of class II and class III devices
reclassified as class I or class II in the previous calendar year
under such section 513(e)(1); and
(3) the number and type of devices reclassified in the previous
calendar year under section 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e).
SEC. 609. HARMONIZATION OF DEVICE PREMARKET REVIEW, INSPECTION, AND
LABELING SYMBOLS.
Paragraph (4) of section 803(c) (21 U.S.C. 383(c)) is amended to
read as follows:
``(4) With respect to devices, the Secretary may, when appropriate,
enter into arrangements with nations regarding methods and approaches
to harmonizing regulatory requirements for activities, including
inspections and common international labeling symbols.''.
SEC. 610. PARTICIPATION IN INTERNATIONAL FORA.
Paragraph (3) of section 803(c) (21 U.S.C. 383(c)) is amended--
(1) by striking ``(3)'' and inserting ``(3)(A)''; and
(2) by adding at the end the following:
``(B) In carrying out subparagraph (A), the Secretary may
participate in appropriate fora, including the International Medical
Device Regulators Forum, and may--
``(i) provide guidance to such fora on strategies, policies,
directions, membership, and other activities of a forum as
appropriate;
``(ii) to the extent appropriate, solicit, review, and consider
comments from industry, academia, health care professionals, and
patient groups regarding the activities of such fora; and
``(iii) to the extent appropriate, inform the public of the
Secretary's activities within such fora, and share with the public
any documentation relating to a forum's strategies, policies, and
other activities of such fora.''.
SEC. 611. REAUTHORIZATION OF THIRD-PARTY REVIEW.
(a) Periodic Reaccreditation.--Section 523(b)(2) (21 U.S.C.
360m(b)(2)) is amended by adding at the end of the following:
``(E) Periodic reaccreditation.--
``(i) Period.--Subject to suspension or withdrawal
under subparagraph (B), any accreditation under this
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.'';
(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.
``(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
``(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--
(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).''.
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:
``(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.
``(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:
``(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 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
``(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.
``(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.''.
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.
``(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. 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).
(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 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;
(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 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.
``(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.
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 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.
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 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 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
``(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.
(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 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.
(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.--
``(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.--
``(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 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 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 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;
(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--
``(i) that is for the prevention or treatment of a rare
pediatric disease; and
``(ii) that contains no active ingredient (including
any ester or salt of the active ingredient) that has been
previously approved in any other application under section
505(b)(1), 505(b)(2), or 505(j) of this Act or section
351(a) or 351(k) of the Public Health Service Act;
``(B) is submitted under section 505(b)(1) of this Act or
section 351(a) of the Public Health Service Act;
``(C) the Secretary deems eligible for priority review;
``(D) that relies on clinical data derived from studies
examining a pediatric population and dosages of the drug
intended for that population;
``(E) that does not seek approval for an adult indication
in the original rare pediatric disease product application; and
``(F) is approved after the date of the enactment of the
Prescription Drug User Fee Amendments of 2012.
``(b) Priority Review Voucher.--
``(1) In general.--The Secretary shall award a priority review
voucher to the sponsor of a rare pediatric disease product
application upon approval by the Secretary of such rare pediatric
disease product application.
``(2) Transferability.--
``(A) In general.--The sponsor of a rare pediatric disease
product application that receives a priority review voucher
under this section may transfer (including by sale) the
entitlement to such voucher. There is no limit on the number of
times a priority review voucher may be transferred before such
voucher is used.
``(B) Notification of transfer.--Each person to whom a
voucher is transferred shall notify the Secretary of such
change in ownership of the voucher not later than 30 days after
such transfer.
``(3) Limitation.--A sponsor of a rare pediatric disease
product application may not receive a priority review voucher under
this section if the rare pediatric disease product application was
submitted to the Secretary prior to the date that is 90 days after
the date of enactment of the Prescription Drug User Fee Amendments
of 2012.
``(4) Notification.--
``(A) In general.--The sponsor of a human drug application
shall notify the Secretary not later than 90 days prior to
submission of the human drug application that is the subject of
a priority review voucher of an intent to submit the human drug
application, including the date on which the sponsor intends to
submit the application. Such notification shall be a legally
binding commitment to pay for the user fee to be assessed in
accordance with this section.
``(B) Transfer after notice.--The sponsor of a human drug
application that provides notification of the intent of such
sponsor to use the voucher for the human drug application under
subparagraph (A) may transfer the voucher after such
notification is provided, if such sponsor has not yet submitted
the human drug application described in the notification.
``(5) Termination of authority.--The Secretary may not award
any priority review vouchers under paragraph (1) after the last day
of the 1-year period that begins on the date that the Secretary
awards the third rare pediatric disease priority voucher under this
section.
``(c) Priority Review User Fee.--
``(1) In general.--The Secretary shall establish a user fee
program under which a sponsor of a human drug application that is
the subject of a priority review voucher shall pay to the Secretary
a fee determined under paragraph (2). Such fee shall be in addition
to any fee required to be submitted by the sponsor under chapter
VII.
``(2) Fee amount.--The amount of the priority review user fee
shall be determined each fiscal year by the Secretary, based on the
difference between--
``(A) the average cost incurred by the Food and Drug
Administration in the review of a human drug application
subject to priority review in the previous fiscal year; and
``(B) the average cost incurred by the Food and Drug
Administration in the review of a human drug application that
is not subject to priority review in the previous fiscal year.
``(3) Annual fee setting.--The Secretary shall establish,
before the beginning of each fiscal year beginning after September
30, 2012, the amount of the priority review user fee for that
fiscal year.
``(4) Payment.--
``(A) In general.--The priority review user fee required by
this subsection shall be due upon the notification by a sponsor
of the intent of such sponsor to use the voucher, as specified
in subsection (b)(4)(A). All other user fees associated with
the human drug application shall be due as required by the
Secretary or under applicable law.
``(B) Complete application.--An application described under
subparagraph (A) for which the sponsor requests the use of a
priority review voucher shall be considered incomplete if the
fee required by this subsection and all other applicable user
fees are not paid in accordance with the Secretary's procedures
for paying such fees.
``(C) No waivers, exemptions, reductions, or refunds.--The
Secretary may not grant a waiver, exemption, reduction, or
refund of any fees due and payable under this section.
``(5) Offsetting collections.--Fees collected pursuant to this
subsection for any fiscal year--
``(A) shall be deposited and credited as offsetting
collections to the account providing appropriations to the Food
and Drug Administration; and
``(B) shall not be collected for any fiscal year except to
the extent provided in advance in appropriations Acts.
``(d) Designation Process.--
``(1) In general.--Upon the request of the manufacturer or the
sponsor of a new drug, the Secretary may designate--
``(A) the new drug as a drug for a rare pediatric disease;
and
``(B) the application for the new drug as a rare pediatric
disease product application.
``(2) Request for designation.--The request for a designation
under paragraph (1) shall be made at the same time a request for
designation of orphan disease status under section 526 or fast-
track designation under section 506 is made. Requesting designation
under this subsection is not a prerequisite to receiving a priority
review voucher under this section.
``(3) Determination by secretary.--Not later than 60 days after
a request is submitted under paragraph (1), the Secretary shall
determine whether--
``(A) the disease or condition that is the subject of such
request is a rare pediatric disease; and
``(B) the application for the new drug is a rare pediatric
disease product application.
``(e) Marketing of Rare Pediatric Disease Products.--
``(1) Revocation.--The Secretary may revoke any priority review
voucher awarded under subsection (b) if the rare pediatric disease
product for which such voucher was awarded is not marketed in the
United States within the 365-day period beginning on the date of
the approval of such drug under section 505 of this Act or section
351 of the Public Health Service Act.
``(2) Postapproval production report.--The sponsor of an
approved rare pediatric disease product shall submit a report to
the Secretary not later than 5 years after the approval of the
applicable rare pediatric disease product application. Such report
shall provide the following information, with respect to each of
the first 4 years after approval of such product:
``(A) The estimated population in the United States
suffering from the rare pediatric disease.
``(B) The estimated demand in the United States for such
rare pediatric disease product.
``(C) The actual amount of such rare pediatric disease
product distributed in the United States.
``(f) Notice and Report.--
``(1) Notice of issuance of voucher and approval of products
under voucher.--The Secretary shall publish a notice in the Federal
Register and on the Internet Web site of the Food and Drug
Administration not later than 30 days after the occurrence of each
of the following:
``(A) The Secretary issues a priority review voucher under
this section.
``(B) The Secretary approves a drug pursuant to an
application submitted under section 505(b) of this Act or
section 351(a) of the Public Health Service Act for which the
sponsor of the application used a priority review voucher under
this section.
``(2) Notification.--If, after the last day of the 1-year
period that begins on the date that the Secretary awards the third
rare pediatric disease priority voucher under this section, a
sponsor of an application submitted under section 505(b) of this
Act or section 351(a) of the Public Health Service Act for a drug
uses a priority review voucher under this section for such
application, the Secretary shall submit to the Committee on Energy
and Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a document--
``(A) notifying such Committees of the use of such voucher;
and
``(B) identifying the drug for which such priority review
voucher is used.
``(g) Eligibility for Other Programs.--Nothing in this section
precludes a sponsor who seeks a priority review voucher under this
section from participating in any other incentive program, including
under this Act.
``(h) Relation to Other Provisions.--The provisions of this section
shall supplement, not supplant, any other provisions of this Act or the
Public Health Service Act that encourage the development of drugs for
tropical diseases and rare pediatric diseases.
``(i) GAO Study and Report.--
``(1) Study.--
``(A) In general.--Beginning on the date that the Secretary
awards the third rare pediatric disease priority voucher under
this section, the Comptroller General of the United States
shall conduct a study of the effectiveness of awarding rare
pediatric disease priority vouchers under this section in the
development of human drug products that treat or prevent such
diseases.
``(B) Contents of study.--In conducting the study under
subparagraph (A), the Comptroller General shall examine the
following:
``(i) The indications for which each rare disease
product for which a priority review voucher was awarded was
approved under section 505 or section 351 of the Public
Health Service Act.
``(ii) Whether, and to what extent, an unmet need
related to the treatment or prevention of a rare pediatric
disease was met through the approval of such a rare disease
product.
``(iii) The value of the priority review voucher if
transferred.
``(iv) Identification of each drug for which a priority
review voucher was used.
``(v) The length of the period of time between the date
on which a priority review voucher was awarded and the date
on which it was used.
``(2) Report.--Not later than 1 year after the date under
paragraph (1)(A), the Comptroller General shall submit to the
Committee on Energy and Commerce of the House of Representatives
and the Committee on Health, Education, Labor, and Pensions of the
Senate, a report containing the results of the study under
paragraph (1).''.
TITLE X--DRUG SHORTAGES
SEC. 1001. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF LIFE-
SAVING DRUGS.
(a) In General.--Section 506C (21 U.S.C. 356c) is amended to read
as follows:
``SEC. 506C. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF LIFE-
SAVING DRUGS.
``(a) In General.--A manufacturer of a drug--
``(1) that is--
``(A) life-supporting;
``(B) life-sustaining; or
``(C) intended for use in the prevention or treatment of a
debilitating disease or condition, including any such drug used
in emergency medical care or during surgery; and
``(2) that is not a radio pharmaceutical drug product or any
other product as designated by the Secretary,
shall notify the Secretary, in accordance with subsection (b), of a
permanent discontinuance in the manufacture of the drug or an
interruption of the manufacture of the drug that is likely to lead to a
meaningful disruption in the supply of that drug in the United States,
and the reasons for such discontinuance or interruption.
``(b) Timing.--A notice required under subsection (a) shall be
submitted to the Secretary--
``(1) at least 6 months prior to the date of the discontinuance
or interruption; or
``(2) if compliance with paragraph (1) is not possible, as soon
as practicable.
``(c) Distribution.--To the maximum extent practicable, the
Secretary shall distribute, through such means as the Secretary deems
appropriate, information on the discontinuation or interruption of the
manufacture of the drugs described in subsection (a) to appropriate
organizations, including physician, health provider, and patient
organizations, as described in section 506E.
``(d) Confidentiality.--Nothing in this section shall be construed
as authorizing the Secretary to disclose any information that is a
trade secret or confidential information subject to section 552(b)(4)
of title 5, United States Code, or section 1905 of title 18, United
States Code.
``(e) Coordination With Attorney General.--Not later than 30 days
after the receipt of a notification described in subsection (a), the
Secretary shall--
``(1) determine whether the notification pertains to a
controlled substance subject to a production quota under section
306 of the Controlled Substances Act; and
``(2) if necessary, as determined by the Secretary--
``(A) notify the Attorney General that the Secretary has
received such a notification;
``(B) request that the Attorney General increase the
aggregate and individual production quotas under section 306 of
the Controlled Substances Act applicable to such controlled
substance and any ingredient therein to a level the Secretary
deems necessary to address a shortage of a controlled substance
based on the best available market data; and
``(C) if the Attorney General determines that the level
requested is not necessary to address a shortage of a
controlled substance, the Attorney General shall provide to the
Secretary a written response detailing the basis for the
Attorney General's determination.
The Secretary shall make the written response provided under
subparagraph (C) available to the public on the Internet Web site
of the Food and Drug Administration.
``(f) Failure To Meet Requirements.--If a person fails to submit
information required under subsection (a) in accordance with subsection
(b)--
``(1) the Secretary shall issue a letter to such person
informing such person of such failure;
``(2) not later than 30 calendar days after the issuance of a
letter under paragraph (1), the person who receives such letter
shall submit to the Secretary a written response to such letter
setting forth the basis for noncompliance and providing information
required under subsection (a); and
``(3) not later than 45 calendar days after the issuance of a
letter under paragraph (1), the Secretary shall make such letter
and any response to such letter under paragraph (2) available to
the public on the Internet Web site of the Food and Drug
Administration, with appropriate redactions made to protect
information described in subsection (d), except that, if the
Secretary determines that the letter under paragraph (1) was issued
in error or, after review of such response, the person had a
reasonable basis for not notifying as required under subsection
(a), the requirements of this paragraph shall not apply.
``(g) Expedited Inspections and Reviews.--If, based on
notifications described in subsection (a) or any other relevant
information, the Secretary concludes that there is, or is likely to be,
a drug shortage of a drug described in subsection (a), the Secretary
may--
``(1) expedite the review of a supplement to a new drug
application submitted under section 505(b), an abbreviated new drug
application submitted under section 505(j), or a supplement to such
an application submitted under section 505(j) that could help
mitigate or prevent such shortage; or
``(2) expedite an inspection or reinspection of an
establishment that could help mitigate or prevent such drug
shortage.
``(h) Definitions.--For purposes of this section--
``(1) the term `drug'--
``(A) means a drug (as defined in section 201(g)) that is
intended for human use and that is subject to section
503(b)(1); and
``(B) does not include biological products (as defined in
section 351 of the Public Health Service Act), unless otherwise
provided by the Secretary in the regulations promulgated under
subsection (i);
``(2) the term `drug shortage' or `shortage', with respect to a
drug, means a period of time when the demand or projected demand
for the drug within the United States exceeds the supply of the
drug; and
``(3) the term `meaningful disruption'--
``(A) means a change in production that is reasonably
likely to lead to a reduction in the supply of a drug by a
manufacturer that is more than negligible and affects the
ability of the manufacturer to fill orders or meet expected
demand for its product; and
``(B) does not include interruptions in manufacturing due
to matters such as routine maintenance or insignificant changes
in manufacturing so long as the manufacturer expects to resume
operations in a short period of time.
``(i) Regulations.--
``(1) In general.--Not later than 18 months after the date of
enactment of the Food and Drug Administration Safety and Innovation
Act, the Secretary shall adopt a final regulation implementing this
section.
``(2) Contents.--Such regulation shall define, for purposes of
this section, the terms `life-supporting', `life-sustaining', and
`intended for use in the prevention or treatment of a debilitating
disease or condition'.
``(3) Inclusion of biological products.--
``(A) In general.--The Secretary may by regulation apply
this section to biological products (as defined in section 351
of the Public Health Service Act), including plasma products
derived from human plasma protein and their recombinant
analogs, if the Secretary determines such inclusion would
benefit the public health. Such regulation shall take into
account any supply reporting programs and shall aim to reduce
duplicative notification.
``(B) Rule for vaccines.--If the Secretary applies this
section to vaccines pursuant to subparagraph (A), the Secretary
shall--
``(i) consider whether the notification requirement
under subsection (a) may be satisfied by submitting a
notification to the Centers for Disease Control and
Prevention under the vaccine shortage notification program
of such Centers; and
``(ii) explain the determination made by the Secretary
under clause (i) in the regulation.
``(4) Procedure.--In promulgating a regulation implementing
this section, the Secretary shall--
``(A) issue a notice of proposed rulemaking that includes
the proposed regulation;
``(B) provide a period of not less than 60 days for
comments on the proposed regulation; and
``(C) publish the final regulation not less than 30 days
before the regulation's effective date.
``(5) Restrictions.--Notwithstanding any other provision of
Federal law, in implementing this section, the Secretary shall only
promulgate regulations as described in paragraph (4).''.
(b) Effect of Notification.--The submission of a notification to
the Secretary of Health and Human Services (referred to in this title
as the ``Secretary'') for purposes of complying with the requirement in
section 506C(a) of the Federal Food, Drug, and Cosmetic Act (as amended
by subsection (a)) shall not be construed--
(1) as an admission that any product that is the subject of
such notification violates any provision of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.); or
(2) as evidence of an intention to promote or market the
product for an indication or use for which the product has not been
approved by the Secretary.
SEC. 1002. ANNUAL REPORTING ON DRUG SHORTAGES.
Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after
section 506C, as amended by section 1001 of this Act, the following:
``SEC. 506C-1. ANNUAL REPORTING ON DRUG SHORTAGES.
``(a) Annual Reports to Congress.--Not later than the end of
calendar year 2013, and not later than the end of each calendar year
thereafter, the Secretary shall submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on drug shortages
that--
``(1) specifies the number of manufacturers that submitted a
notification to the Secretary under section 506C(a) during such
calendar year;
``(2) describes the communication between the field
investigators of the Food and Drug Administration and the staff of
the Center for Drug Evaluation and Research's Office of Compliance
and Drug Shortage Program, including the Food and Drug
Administration's procedures for enabling and ensuring such
communication;
``(3)(A) lists the major actions taken by the Secretary to
prevent or mitigate the drug shortages described in paragraph (7);
``(B) in the list under subparagraph (A), includes--
``(i) the number of applications and supplements for which
the Secretary expedited review under section 506C(g)(1) during
such calendar year; and
``(ii) the number of establishment inspections or
reinspections that the Secretary expedited under section
506C(g)(2) during such calendar year;
``(4) describes the coordination between the Food and Drug
Administration and the Drug Enforcement Administration on efforts
to prevent or alleviate drug shortages;
``(5) identifies the number of and describes the instances in
which the Food and Drug Administration exercised regulatory
flexibility and discretion to prevent or alleviate a drug shortage;
``(6) lists the names of manufacturers that were issued letters
under section 506C(f); and
``(7) specifies the number of drug shortages occurring during
such calendar year, as identified by the Secretary.
``(b) Trend Analysis.--The Secretary is authorized to retain a
third party to conduct a study, if the Secretary believes such a study
would help clarify the causes, trends, or solutions related to drug
shortages.
``(c) Definition.--In this section, the term `drug shortage' or
`shortage' has the meaning given such term in section 506C.''.
SEC. 1003. COORDINATION; TASK FORCE AND STRATEGIC PLAN.
Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after
section 506C-1, as added by section 1002 of this Act, the following:
``SEC. 506D. COORDINATION; TASK FORCE AND STRATEGIC PLAN.
``(a) Task Force and Strategic Plan.--
``(1) In general.--
``(A) Task force.--As soon as practicable after the date of
enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall establish a task force to
develop and implement a strategic plan for enhancing the
Secretary's response to preventing and mitigating drug
shortages.
``(B) Strategic plan.--The strategic plan described in
subparagraph (A) shall include--
``(i) plans for enhanced interagency and intra-agency
coordination, communication, and decisionmaking;
``(ii) plans for ensuring that drug shortages are
considered when the Secretary initiates a regulatory action
that could precipitate a drug shortage or exacerbate an
existing drug shortage;
``(iii) plans for effective communication with outside
stakeholders, including who the Secretary should alert
about potential or actual drug shortages, how the
communication should occur, and what types of information
should be shared;
``(iv) plans for considering the impact of drug
shortages on research and clinical trials; and
``(v) an examination of whether to establish a
`qualified manufacturing partner program', as described in
subparagraph (C).
``(C) Description of program.--In conducting the
examination of a `qualified manufacturing partner program'
under subparagraph (B)(v), the Secretary--
``(i) shall take into account that--
``(I) a `qualified manufacturer', for purposes of
such program, would need to have the capability and
capacity to supply products determined or anticipated
to be in shortage; and
``(II) in examining the capability and capacity to
supply products in shortage, the `qualified
manufacturer' could have a site that manufactures a
drug listed under section 506E or have the capacity to
produce drugs in response to a shortage within a rapid
timeframe; and
``(ii) shall examine whether incentives are necessary
to encourage the participation of `qualified manufacturers'
in such a program.
``(D) Consultation.--In carrying out this paragraph, the
task force shall ensure consultation with the appropriate
offices within the Food and Drug Administration, including the
Office of the Commissioner, the Center for Drug Evaluation and
Research, the Office of Regulatory Affairs, and employees
within the Department of Health and Human Services with
expertise regarding drug shortages. The Secretary shall engage
external stakeholders and experts as appropriate.
``(2) Timing.--Not later than 1 year after the date of
enactment of the Food and Drug Administration Safety and Innovation
Act, the task force shall--
``(A) publish the strategic plan described in paragraph
(1); and
``(B) submit such plan to Congress.
``(b) Communication.--The Secretary shall ensure that, prior to any
enforcement action or issuance of a warning letter that the Secretary
determines could reasonably be anticipated to lead to a meaningful
disruption in the supply in the United States of a drug described under
section 506C(a), there is communication with the appropriate office of
the Food and Drug Administration with expertise regarding drug
shortages regarding whether the action or letter could cause, or
exacerbate, a shortage of the drug.
``(c) Action.--If the Secretary determines, after the communication
described in subsection (b), that an enforcement action or a warning
letter could reasonably cause or exacerbate a shortage of a drug
described under section 506C(a), then the Secretary shall evaluate the
risks associated with the impact of such shortage upon patients and
those risks associated with the violation involved before taking such
action or issuing such letter, unless there is imminent risk of serious
adverse health consequences or death to humans.
``(d) Reporting by Other Entities.--The Secretary shall identify or
establish a mechanism by which health care providers and other third-
party organizations may report to the Secretary evidence of a drug
shortage.
``(e) Review and Construction.--No determination, finding, action,
or omission of the Secretary under this section shall--
``(1) be subject to judicial review; or
``(2) be construed to establish a defense to an enforcement
action by the Secretary.
``(f) Sunset.--Subsections (a), (b), (c), and (e) shall cease to be
effective on the date that is 5 years after the date of enactment of
the Food and Drug Administration Safety and Innovation Act.''.
SEC. 1004. DRUG SHORTAGE LIST.
Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after
section 506D, as added by section 1003 of this Act, the following:
``SEC. 506E. DRUG SHORTAGE LIST.
``(a) Establishment.--The Secretary shall maintain an up-to-date
list of drugs that are determined by the Secretary to be in shortage in
the United States.
``(b) Contents.--For each drug on such list, the Secretary shall
include the following information:
``(1) The name of the drug in shortage, including the National
Drug Code number for such drug.
``(2) The name of each manufacturer of such drug.
``(3) The reason for the shortage, as determined by the
Secretary, selecting from the following categories:
``(A) Requirements related to complying with good
manufacturing practices.
``(B) Regulatory delay.
``(C) Shortage of an active ingredient.
``(D) Shortage of an inactive ingredient component.
``(E) Discontinuation of the manufacture of the drug.
``(F) Delay in shipping of the drug.
``(G) Demand increase for the drug.
``(4) The estimated duration of the shortage as determined by
the Secretary.
``(c) Public Availability.--
``(1) In general.--Subject to paragraphs (2) and (3), the
Secretary shall make the information in such list publicly
available.
``(2) Trade secrets and confidential information.--Nothing in
this section alters or amends section 1905 of title 18, United
States Code, or section 552(b)(4) of title 5 of such Code.
``(3) Public health exception.--The Secretary may choose not to
make information collected under this section publicly available
under paragraph (1) or section 506C(c) if the Secretary determines
that disclosure of such information would adversely affect the
public health (such as by increasing the possibility of hoarding or
other disruption of the availability of drug products to
patients).''.
SEC. 1005. QUOTAS APPLICABLE TO DRUGS IN SHORTAGE.
Section 306 of the Controlled Substances Act (21 U.S.C. 826) is
amended by adding at the end the following:
``(h)(1) Not later than 30 days after the receipt of a request
described in paragraph (2), the Attorney General shall--
``(A) complete review of such request; and
``(B)(i) as necessary to address a shortage of a controlled
substance, increase the aggregate and individual production quotas
under this section applicable to such controlled substance and any
ingredient therein to the level requested; or
``(ii) if the Attorney General determines that the level
requested is not necessary to address a shortage of a controlled
substance, the Attorney General shall provide a written response
detailing the basis for the Attorney General's determination.
The Secretary shall make the written response provided under
subparagraph (B)(ii) available to the public on the Internet Web site
of the Food and Drug Administration.
``(2) A request is described in this paragraph if--
``(A) the request pertains to a controlled substance on the
list of drugs in shortage maintained under section 506E of the
Federal Food, Drug, and Cosmetic Act;
``(B) the request is submitted by the manufacturer of the
controlled substance; and
``(C) the controlled substance is in schedule II.''.
SEC. 1006. ATTORNEY GENERAL REPORT ON DRUG SHORTAGES.
Not later than 6 months after the date of the enactment of this
Act, and annually thereafter, the Attorney General shall submit to the
Committee on Energy and Commerce of the House of Representatives and
the Committee on the Judiciary of the Senate a report on drug shortages
that--
(1) identifies the number of requests received under section
306(h) of the Controlled Substances Act (as added by section 1005
of this Act), the average review time for such requests, the number
of requests granted and denied under such section, and, for each of
the requests denied under such section, the basis for such denial;
(2) describes the coordination between the Drug Enforcement
Administration and Food and Drug Administration on efforts to
prevent or alleviate drug shortages; and
(3) identifies drugs containing a controlled substance subject
to section 306 of the Controlled Substances Act when such a drug is
determined by the Secretary to be in shortage.
SEC. 1007. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.
Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after
section 506E, as added by section 1004 of this Act, the following:
``SEC. 506F. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.
``(a) Definitions.--In this section:
``(1) Drug.--The term `drug' excludes any controlled substance
(as such term is defined in section 102 of the Controlled
Substances Act).
``(2) Health system.--The term `health system' means a
collection of hospitals that are owned and operated by the same
entity and that share access to databases with drug order
information for their patients.
``(3) Repackage.--For the purposes of this section only, the
term `repackage', with respect to a drug, means to divide the
volume of a drug into smaller amounts in order to--
``(A) extend the supply of a drug in response to the
placement of the drug on a drug shortage list under section
506E; and
``(B) facilitate access to the drug by hospitals within the
same health system.
``(b) Exclusion From Registration.--Notwithstanding any other
provision of this Act, a hospital shall not be considered an
establishment for which registration is required under section 510
solely because it repackages a drug and transfers it to another
hospital within the same health system in accordance with the
conditions in subsection (c)--
``(1) during any period in which the drug is listed on the drug
shortage list under section 506E; or
``(2) during the 60-day period following any period described
in paragraph (1).
``(c) Conditions.--Subsection (b) shall only apply to a hospital,
with respect to the repackaging of a drug for transfer to another
hospital within the same health system, if the following conditions are
met:
``(1) Drug for intrasystem use only.--In no case may a drug
that has been repackaged in accordance with this section be sold or
otherwise distributed by the health system or a hospital within the
system to an entity or individual that is not a hospital within
such health system.
``(2) Compliance with state rules.--Repackaging of a drug under
this section shall be done in compliance with applicable State
requirements of each State in which the drug is repackaged and
received.
``(d) Termination.--This section shall not apply on or after the
date on which the Secretary issues final guidance that clarifies the
policy of the Food and Drug Administration regarding hospital
pharmacies repackaging and safely transferring repackaged drugs to
other hospitals within the same health system during a drug
shortage.''.
SEC. 1008. STUDY ON DRUG SHORTAGES.
(a) Study.--The Comptroller General of the United States shall
conduct a study to examine the cause of drug shortages and formulate
recommendations on how to prevent or alleviate such shortages.
(b) Consideration.--In conducting the study under this section, the
Comptroller General shall consider the following questions:
(1) What are the dominant characteristics of drugs that have
gone into a drug shortage over the preceding 3 years?
(2) Are there systemic high-risk factors (such as drug pricing
structure, including Federal reimbursements, or the number of
manufacturers producing a drug product) that have led to the
concentration of drug shortages in certain drug products that have
made such products vulnerable to drug shortages?
(3) Is there a reason why drug shortages have occurred
primarily in the sterile injectable market and in certain
therapeutic areas?
(4)(A) How have regulations, guidance documents, regulatory
practices, policies, and other actions of Federal departments and
agencies (including the effectiveness of interagency and intra-
agency coordination, communication, strategic planning, and
decisionmaking), including those used to enforce statutory
requirements, affected drug shortages?
(B) Do any such regulations, guidances, policies, or practices
cause, exacerbate, prevent, or mitigate drug shortages?
(C) How can regulations, guidances, policies, or practices be
modified, streamlined, expanded, or discontinued in order to reduce
or prevent such drug shortages?
(D) What effect would the changes described in subparagraph (C)
have on the public health?
(5) How does hoarding affect drug shortages?
(6) How would incentives alleviate or prevent drug shortages?
(7) To what extent are health care providers, including
hospitals and physicians responding to drug shortages, able to
adjust care effectively to compensate for such shortages, and what
impediments exist that hinder provider ability to adjust to such
shortages?
(8)(A) Have drug shortages led market participants to stockpile
affected drugs or sell such drugs at inflated prices?
(B) What has been the impact of any such activities described
in subparagraph (A) on Federal revenue, and are there any economic
factors that have exacerbated or created a market for such
activities?
(C) Is there a need for any additional reporting or enforcement
actions to address such activities?
(9)(A) How have the activities under section 506D of the
Federal Food, Drug, and Cosmetic Act (as added by section 1003 of
this Act) improved the efforts of the Food and Drug Administration
to mitigate and prevent drug shortages?
(B) Is there a need to continue the task force and strategic
plan under such section 506D, or are there any other
recommendations to increase communication and coordination inside
the Food and Drug Administration, between the Food and Drug
Administration and other agencies, and between the Food and Drug
Administration and stakeholders?
(c) Consultation With Stakeholders.--In conducting the study under
this section, the Comptroller General shall consult with relevant
stakeholders, including physicians, pharmacists, hospitals, patients,
drug manufacturers, and other health providers.
(d) Report.--Not later than 18 months after the date of the
enactment of this Act, the Comptroller General shall submit a report to
the Committee on Energy and Commerce of the House of Representatives
and the Committee on Health, Education, Labor, and Pensions of the
Senate on the results of the study under this section.
TITLE XI--OTHER PROVISIONS
Subtitle A--Reauthorizations
SEC. 1101. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF
CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.
(a) In General.--Section 505(u)(4) (21 U.S.C. 355(u)(4)) is amended
by striking ``2012'' and inserting ``2017''.
(b) Amendment.--Section 505(u)(1)(A)(ii)(II) (21 U.S.C.
355(u)(1)(A)(ii)(II)) is amended by inserting ``clinical'' after
``any''.
SEC. 1102. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE
PARTNERSHIPS.
Subsection (f) of section 566 (21 U.S.C. 360bbb-5) is amended to
read as follows:
``(f) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $6,000,000 for each of fiscal
years 2013 through 2017.''.
Subtitle B--Medical Gas Product Regulation
SEC. 1111. REGULATION OF MEDICAL GASES.
Chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end
the following:
``Subchapter G--Medical Gases
``SEC. 575. DEFINITIONS.
``In this subchapter:
``(1) The term `designated medical gas' means any of the
following:
``(A) Oxygen that meets the standards set forth in an
official compendium.
``(B) Nitrogen that meets the standards set forth in an
official compendium.
``(C) Nitrous oxide that meets the standards set forth in
an official compendium.
``(D) Carbon dioxide that meets the standards set forth in
an official compendium.
``(E) Helium that meets the standards set forth in an
official compendium.
``(F) Carbon monoxide that meets the standards set forth in
an official compendium.
``(G) Medical air that meets the standards set forth in an
official compendium.
``(H) Any other medical gas deemed appropriate by the
Secretary, after taking into account any investigational new
drug application or investigational new animal drug application
for the same medical gas submitted in accordance with
regulations applicable to such applications in title 21 of the
Code of Federal Regulations, unless any period of exclusivity
under section 505(c)(3)(E)(ii) or section 505(j)(5)(F)(ii), or
the extension of any such period under section 505A, applicable
to such medical gas has not expired.
``(2) The term `medical gas' means a drug that--
``(A) is manufactured or stored in a liquefied,
nonliquefied, or cryogenic state; and
``(B) is administered as a gas.
``SEC. 576. REGULATION OF MEDICAL GASES.
``(a) Certification of Designated Medical Gases.--
``(1) Submission.--Beginning 180 days after the date of
enactment of this section, any person may file with the Secretary a
request for certification of a medical gas as a designated medical
gas. Any such request shall contain the following information:
``(A) A description of the medical gas.
``(B) The name and address of the sponsor.
``(C) The name and address of the facility or facilities
where the medical gas is or will be manufactured.
``(D) Any other information deemed appropriate by the
Secretary to determine whether the medical gas is a designated
medical gas.
``(2) Grant of certification.--The certification requested
under paragraph (1) is deemed to be granted unless, within 60 days
of the filing of such request, the Secretary finds that--
``(A) the medical gas subject to the certification is not a
designated medical gas;
``(B) the request does not contain the information required
under paragraph (1) or otherwise lacks sufficient information
to permit the Secretary to determine that the medical gas is a
designated medical gas; or
``(C) denying the request is necessary to protect the
public health.
``(3) Effect of certification.--
``(A) In general.--
``(i) Approved uses.--A designated medical gas for
which a certification is granted under paragraph (2) is
deemed, alone or in combination, as medically appropriate,
with another designated medical gas or gases for which a
certification or certifications have been granted, to have
in effect an approved application under section 505 or 512,
subject to all applicable postapproval requirements, for
the following indications for use:
``(I) In the case of oxygen, the treatment or
prevention of hypoxemia or hypoxia.
``(II) In the case of nitrogen, use in hypoxic
challenge testing.
``(III) In the case of nitrous oxide, analgesia.
``(IV) In the case of carbon dioxide, use in
extracorporeal membrane oxygenation therapy or
respiratory stimulation.
``(V) In the case of helium, the treatment of upper
airway obstruction or increased airway resistance.
``(VI) In the case of medical air, to reduce the
risk of hyperoxia.
``(VII) In the case of carbon monoxide, use in lung
diffusion testing.
``(VIII) Any other indication for use for a
designated medical gas or combination of designated
medical gases deemed appropriate by the Secretary,
unless any period of exclusivity under clause (iii) or
(iv) of section 505(c)(3)(E), clause (iii) or (iv) of
section 505(j)(5)(F), or section 527, or the extension
of any such period under section 505A, applicable to
such indication for use for such gas or combination of
gases has not expired.
``(ii) Labeling.--The requirements of sections
503(b)(4) and 502(f) are deemed to have been met for a
designated medical gas if the labeling on final use
container for such medical gas bears--
``(I) the information required by section
503(b)(4);
``(II) a warning statement concerning the use of
the medical gas as determined by the Secretary by
regulation; and
``(III) appropriate directions and warnings
concerning storage and handling.
``(B) Inapplicability of exclusivity provisions.--
``(i) No exclusivity for a certified medical gas.--No
designated medical gas deemed under subparagraph (A)(i) to
have in effect an approved application is eligible for any
period of exclusivity under section 505(c), 505(j), or 527,
or the extension of any such period under section 505A, on
the basis of such deemed approval.
``(ii) Effect on certification.--No period of
exclusivity under section 505(c), 505(j), or section 527,
or the extension of any such period under section 505A,
with respect to an application for a drug product shall
prohibit, limit, or otherwise affect the submission, grant,
or effect of a certification under this section, except as
provided in subsection (a)(3)(A)(i)(VIII) and section
575(1)(H).
``(4) Withdrawal, suspension, or revocation of approval.--
``(A) Withdrawal, suspension of approval.--Nothing in this
subchapter limits the Secretary's authority to withdraw or
suspend approval of a drug product, including a designated
medical gas deemed under this section to have in effect an
approved application under section 505 or section 512 of this
Act.
``(B) Revocation of certification.--The Secretary may
revoke the grant of a certification under paragraph (2) if the
Secretary determines that the request for certification
contains any material omission or falsification.
``(b) Prescription Requirement.--
``(1) In general.--A designated medical gas shall be subject to
the requirements of section 503(b)(1) unless the Secretary
exercises the authority provided in section 503(b)(3) to remove
such medical gas from the requirements of section 503(b)(1), the
gas is approved for use without a prescription pursuant to an
application under section 505 or 512, or the use in question is
authorized pursuant to another provision of this Act relating to
use of medical products in emergencies.
``(2) Oxygen.--
``(A) No prescription required for certain uses.--
Notwithstanding paragraph (1), oxygen may be provided without a
prescription for the following uses:
``(i) For use in the event of depressurization or other
environmental oxygen deficiency.
``(ii) For oxygen deficiency or for use in emergency
resuscitation, when administered by properly trained
personnel.
``(B) Labeling.--For oxygen provided pursuant to
subparagraph (A), the requirements of section 503(b)(4) shall
be deemed to have been met if its labeling bears a warning that
the oxygen can be used for emergency use only and for all other
medical applications a prescription is required.
``SEC. 577. INAPPLICABILITY OF DRUG FEES TO DESIGNATED MEDICAL
GASES.
``A designated medical gas, alone or in combination with another
designated gas or gases (as medically appropriate) deemed under section
576 to have in effect an approved application shall not be assessed
fees under section 736(a) on the basis of such deemed approval.''.
SEC. 1112. CHANGES TO REGULATIONS.
(a) Report.--Not later than 18 months after the date of the
enactment of this Act, the Secretary, after obtaining input from
medical gas manufacturers and any other interested members of the
public, shall--
(1) determine whether any changes to the Federal drug
regulations are necessary for medical gases; and
(2) submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of
the House of Representatives a report regarding any such changes.
(b) Regulations.--If the Secretary determines under subsection (a)
that changes to the Federal drug regulations are necessary for medical
gases, the Secretary shall issue final regulations revising the Federal
drug regulations with respect to medical gases not later than 48 months
after the date of the enactment of this Act.
(c) Definitions.--In this section:
(1) The term ``Federal drug regulations'' means regulations in
title 21 of the Code of Federal Regulations pertaining to drugs.
(2) The term ``medical gas'' has the meaning given to such term
in section 575 of the Federal Food, Drug, and Cosmetic Act, as
added by section 1111 of this Act.
(3) The term ``Secretary'' means the Secretary of Health and
Human Services, acting through the Commissioner of Food and Drugs.
SEC. 1113. RULES OF CONSTRUCTION.
Nothing in this subtitle and the amendments made by this subtitle
applies with respect to--
(1) a drug that is approved prior to May 1, 2012, pursuant to
an application submitted under section 505 or 512 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360b);
(2) any gas listed in subparagraphs (A) through (G) of section
575(1) of the Federal Food, Drug, and Cosmetic Act, as added by
section 1111 of this Act, or any combination of any such gases, for
an indication that--
(A) is not included in, or is different from, those
specified in subclauses (I) through (VII) of section
576(a)(3)(A)(i) of such Act; and
(B) is approved on or after May 1, 2012, pursuant to an
application submitted under section 505 or 512; or
(3) any designated medical gas added pursuant to subparagraph
(H) of section 575(1) of such Act for an indication that--
(A) is not included in, or is different from, those
originally added pursuant to subparagraph (H) of section 575(1)
and section 576(a)(3)(A)(i)(VIII); and
(B) is approved on or after May 1, 2012, pursuant to an
application submitted under section 505 or 512 of such Act.
Subtitle C--Miscellaneous Provisions
SEC. 1121. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION USING THE
INTERNET.
Not later than 2 years after the date of enactment of this Act, the
Secretary of Health and Human Services shall issue guidance that
describes Food and Drug Administration policy regarding the promotion,
using the Internet (including social media), of medical products that
are regulated by such Administration.
SEC. 1122. COMBATING PRESCRIPTION DRUG ABUSE.
(a) In General.--To combat the significant rise in prescription
drug abuse and the consequences of such abuse, the Secretary of Health
and Human Services (referred to in this section as the ``Secretary''),
in coordination with other Federal agencies, as appropriate, shall
review current Federal initiatives and identify gaps and opportunities
with respect to--
(1) ensuring the safe use of prescription drugs with the
potential for abuse; and
(2) the treatment of prescription drug dependance.
(b) Report.--Not later than 1 year after the date of enactment of
this Act, the Secretary shall post on the Department of Health and
Human Service's Internet Web site a report on the findings of the
review under subsection (a). Such report shall include findings and
recommendations on--
(1) how best to leverage and build upon existing Federal and
federally funded data sources, such as prescription drug monitoring
program data and the sentinel initiative of the Food and Drug
Administration under section 505(k)(3) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 351(k)(3)), as it relates to collection
of information relevant to adverse events, patient safety, and
patient outcomes, to create a centralized data clearinghouse and
early warning tool;
(2) how best to develop and disseminate widely best practices
models and suggested standard requirements to States for achieving
greater interoperability and effectiveness of prescription drug
monitoring programs, especially with respect to provider
participation, producing standardized data on adverse events,
patient safety, and patient outcomes; and
(3) how best to develop provider, pharmacist, and patient
education tools and a strategy to widely disseminate such tools and
assess the efficacy of such tools.
(c) Guidance on Abuse-Deterrent Products.--Not later than 6 months
after the date of enactment of this Act, the Secretary shall promulgate
guidance on the development of abuse-deterrent drug products.
SEC. 1123. OPTIMIZING GLOBAL CLINICAL TRIALS.
Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as amended by
section 903 of this Act, is further amended by adding at the end the
following:
``SEC. 569A. OPTIMIZING GLOBAL CLINICAL TRIALS.
``(a) In General.--The Secretary shall--
``(1) work with other regulatory authorities of similar
standing, medical research companies, and international
organizations to foster and encourage uniform, scientifically
driven clinical trial standards with respect to medical products
around the world; and
``(2) enhance the commitment to provide consistent parallel
scientific advice to manufacturers seeking simultaneous global
development of new medical products in order to--
``(A) enhance medical product development;
``(B) facilitate the use of foreign data; and
``(C) minimize the need to conduct duplicative clinical
studies, preclinical studies, or nonclinical studies.
``(b) Medical Product.--In this section, the term `medical product'
means a drug, as defined in subsection (g) of section 201, a device, as
defined in subsection (h) of such section, or a biological product, as
defined in section 351(i) of the Public Health Service Act.
``(c) Savings Clause.--Nothing in this section shall alter the
criteria for evaluating the safety or effectiveness of a medical
product under this Act.
``SEC. 569B. USE OF CLINICAL INVESTIGATION DATA FROM OUTSIDE THE UNITED
STATES.
``(a) In General.--In determining whether to approve, license, or
clear a drug or device pursuant to an application submitted under this
chapter, the Secretary shall accept data from clinical investigations
conducted outside of the United States, including the European Union,
if the applicant demonstrates that such data are adequate under
applicable standards to support approval, licensure, or clearance of
the drug or device in the United States.
``(b) Notice to Sponsor.--If the Secretary finds under subsection
(a) that the data from clinical investigations conducted outside the
United States, including in the European Union, are inadequate for the
purpose of making a determination on approval, clearance, or licensure
of a drug or device pursuant to an application submitted under this
chapter, the Secretary shall provide written notice to the sponsor of
the application of such finding and include the rationale for such
finding.''.
SEC. 1124. ADVANCING REGULATORY SCIENCE TO PROMOTE PUBLIC HEALTH
INNOVATION.
(a) In General.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') shall develop a strategy and
implementation plan for advancing regulatory science for medical
products in order to promote the public health and advance innovation
in regulatory decisionmaking.
(b) Requirements.--The strategy and implementation plan developed
under subsection (a) shall be consistent with the user fee performance
goals in the Prescription Drug User Fee Agreement commitment letter,
the Generic Drug User Fee Agreement commitment letter, and the
Biosimilar User Fee Agreement commitment letter transmitted by the
Secretary to Congress on January 13, 2012, and the Medical Device User
Fee Agreement commitment letter transmitted by the Secretary to
Congress on April 20, 2012, and shall--
(1) identify a clear vision of the fundamental role of
efficient, consistent, and predictable, science-based decisions
throughout regulatory decisionmaking of the Food and Drug
Administration with respect to medical products;
(2) identify the regulatory science priorities of the Food and
Drug Administration directly related to fulfilling the mission of
the agency with respect to decisionmaking concerning medical
products and allocation of resources toward such regulatory science
priorities;
(3) identify regulatory and scientific gaps that impede the
timely development and review of, and regulatory certainty with
respect to, the approval, licensure, or clearance of medical
products, including with respect to companion products and new
technologies, and facilitating the timely introduction and adoption
of new technologies and methodologies in a safe and effective
manner;
(4) identify clear, measurable metrics by which progress on the
priorities identified under paragraph (2) and gaps identified under
paragraph (3) will be measured by the Food and Drug Administration,
including metrics specific to the integration and adoption of
advances in regulatory science described in paragraph (5) and
improving medical product decisionmaking, in a predictable and
science-based manner; and
(5) set forth how the Food and Drug Administration will ensure
that advances in regulatory science for medical products are
adopted, as appropriate, on an ongoing basis and in an manner
integrated across centers, divisions, and branches of the Food and
Drug Administration, including by senior managers and reviewers,
including through the--
(A) development, updating, and consistent application of
guidance documents that support medical product decisionmaking;
and
(B) adoption of the tools, methods, and processes under
section 566 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-5).
(c) Performance Reports.--The annual performance reports submitted
to Congress under sections 736B(a) (as amended by section 104 of this
Act), 738A(a) (as amended by section 204 of this Act), 744C(a) (as
added by section 303 of this Act), and 744I(a) (as added by section 403
of this Act) of the Federal Food, Drug, and Cosmetic Act for each of
fiscal years 2014 and 2016, shall include a report from the Secretary
on the progress made with respect to--
(1) advancing the regulatory science priorities identified
under paragraph (2) of subsection (b) and resolving the gaps
identified under paragraph (3) of such subsection, including
reporting on specific metrics identified under paragraph (4) of
such subsection;
(2) the integration and adoption of advances in regulatory
science as set forth in paragraph (5) of such subsection; and
(3) the progress made in advancing the regulatory science goals
outlined in the Prescription Drug User Fee Agreement commitment
letter, the Generic Drug User Fee Agreement commitment letter, and
the Biosimilar User Fee Agreement commitment letter transmitted by
the Secretary to Congress on January 13, 2012, and the Medical
Device User Fee Agreement transmitted by the Secretary to Congress
on April 20, 2012.
(d) Medical Product.--In this section, the term ``medical product''
means a drug, as defined in subsection (g) of section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), a device, as
defined in subsection (h) of such section, or a biological product, as
defined in section 351(i) of the Public Health Service Act.
SEC. 1125. INFORMATION TECHNOLOGY.
(a) HHS Report.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services shall--
(1) report to Congress on--
(A) the milestones and a completion date for developing and
implementing a comprehensive information technology strategic
plan to align the information technology systems modernization
projects with the strategic goals of the Food and Drug
Administration, including results-oriented goals, strategies,
milestones, performance measures;
(B) efforts to finalize and approve a comprehensive
inventory of the information technology systems of the Food and
Drug Administration that includes information describing each
system, such as costs, system function or purpose, and status
information, and incorporate use of the system portfolio into
the information investment management process of the Food and
Drug Administration;
(C) the ways in which the Food and Drug Administration uses
the plan described in subparagraph (A) to guide and coordinate
the modernization projects and activities of the Food and Drug
Administration, including the interdependencies among projects
and activities; and
(D) the extent to which the Food and Drug Administration
has fulfilled or is implementing recommendations of the
Government Accountability Office with respect to the Food and
Drug Administration and information technology; and
(2) develop--
(A) a documented enterprise architecture program management
plan that includes the tasks, activities, and timeframes
associated with developing and using the architecture and
addresses how the enterprise architecture program management
will be performed in coordination with other management
disciplines, such as organizational strategic planning, capital
planning and investment control, and performance management;
and
(B) a skills inventory, needs assessment, gap analysis, and
initiatives to address skills gaps as part of a strategic
approach to information technology human capital planning.
(b) GAO Report.--Not later than January 1, 2016, the Comptroller
General of the United States shall issue a report regarding the
strategic plan described in subsection (a)(1)(A) and related actions
carried out by the Food and Drug Administration. Such report shall
assess the progress the Food and Drug Administration has made on--
(1) the development and implementation of a comprehensive
information technology strategic plan, including the results-
oriented goals, strategies, milestones, and performance measures
identified in subsection (a)(1)(A);
(2) the effectiveness of the comprehensive information
technology strategic plan described in subsection (a)(1)(A),
including the results-oriented goals and performance measures; and
(3) the extent to which the Food and Drug Administration has
fulfilled recommendations of the Government Accountability Office
with respect to such agency and information technology.
SEC. 1126. NANOTECHNOLOGY.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall intensify and
expand activities related to enhancing scientific knowledge regarding
nanomaterials included or intended for inclusion in products regulated
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
or other statutes administered by the Food and Drug Administration, to
address issues relevant to the regulation of those products, including
the potential toxicology of such nanomaterials, the potential benefit
of new therapies derived from nanotechnology, the effects of such
nanomaterials on biological systems, and the interaction of such
nanomaterials with biological systems.
(b) Activities.--In conducting activities related to
nanotechnology, the Secretary may--
(1) assess scientific literature and data on general
nanomaterials interactions with biological systems and on specific
nanomaterials of concern to the Food and Drug Administration;
(2) in cooperation with other Federal agencies, develop and
organize information using databases and models that will
facilitate the identification of generalized principles and
characteristics regarding the behavior of classes of nanomaterials
with biological systems;
(3) promote Food and Drug Administration programs and
participate in collaborative efforts, to further the understanding
of the science of novel properties of nanomaterials that might
contribute to toxicity;
(4) promote and participate in collaborative efforts to further
the understanding of measurement and detection methods for
nanomaterials;
(5) collect, synthesize, interpret, and disseminate scientific
information and data related to the interactions of nanomaterials
with biological systems;
(6) build scientific expertise on nanomaterials within the Food
and Drug Administration, including field and laboratory expertise,
for monitoring the production and presence of nanomaterials in
domestic and imported products regulated under this Act;
(7) ensure ongoing training, as well as dissemination of new
information within the centers of the Food and Drug Administration,
and more broadly across the Food and Drug Administration, to ensure
timely, informed consideration of the most current science
pertaining to nanomaterials;
(8) encourage the Food and Drug Administration to participate
in international and national consensus standards activities
pertaining to nanomaterials; and
(9) carry out other activities that the Secretary determines
are necessary and consistent with the purposes described in
paragraphs (1) through (8).
SEC. 1127. ONLINE PHARMACY REPORT TO CONGRESS.
Not later than 1 year after the date of enactment of this Act, the
Comptroller General of the United States shall submit to the Committee
on Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives a
report that describes any problems posed by pharmacy Internet Web sites
that violate Federal or State law, including--
(1) the methods by which Internet Web sites are used to sell
prescription drugs in violation of Federal or State law or
established industry standards;
(2) the harmful health effects that patients experience when
they consume prescription drugs purchased through such pharmacy
Internet Web sites;
(3) efforts by the Federal Government and State and local
governments to investigate and prosecute the owners or operators of
pharmacy Internet Web sites, to address the threats such Web sites
pose, and to protect patients;
(4) the level of success that Federal, State, and local
governments have experienced in investigating and prosecuting such
cases;
(5) whether the law, as in effect on the date of the report,
provides sufficient authorities to Federal, State, and local
governments to investigate and prosecute the owners and operators
of pharmacy Internet Web sites that violate Federal or State law or
established industry standards;
(6) additional authorities that could assist Federal, State,
and local governments in investigating and prosecuting the owners
and operators of pharmacy Internet Web sites that violate Federal
or State law or established industry standards;
(7) laws, policies, and activities that would educate consumers
about how to distinguish pharmacy Internet Web sites that comply
with Federal and State laws and established industry standards from
those pharmacy Internet Web sites that do not comply with such laws
and standards; and
(8) activities that private sector actors are taking to address
the prevalence of illegitimate pharmacy Internet Web sites, and any
policies to encourage further activities.
SEC. 1128. REPORT ON SMALL BUSINESSES.
Not later than 1 year after the date of enactment of this Act, the
Commissioner of Food and Drugs shall submit a report to Congress that
includes--
(1) a listing of and staffing levels of all small business
offices at the Food and Drug Administration, including the small
business liaison program;
(2) the status of partnership efforts between the Food and Drug
Administration and the Small Business Administration;
(3) a summary of outreach efforts to small businesses and small
business associations, including availability of toll-free
telephone help lines;
(4) with respect to the program under the Orphan Drug Act
(Public Law 97-414), the number of applications made by small
businesses and number of applications approved for research grants
and the number of companies receiving protocol assistance for the
development of drugs for rare diseases and disorders;
(5) the number of small businesses submitting applications and
receiving approval for unsolicited grant applications from the Food
and Drug Administration;
(6) the number of small businesses submitting applications and
receiving approval for solicited grant applications from the Food
and Drug Administration; and
(7) barriers small businesses encounter in the drug and medical
device approval process.
SEC. 1129. PROTECTIONS FOR THE COMMISSIONED CORPS OF THE PUBLIC HEALTH
SERVICE ACT.
(a) In General.--Section 221(a) of the Public Health Service Act
(42 U.S.C. 213a(a)) is amended by adding at the end the following:
``(18) Section 1034, Protected Communications; Prohibition of
Retaliatory Personnel Actions.''.
(b) Conforming Amendment.--Section 221(b) of the Public Health
Service Act (42 U.S.C. 213a(b)) is amended by adding at the end the
following: ``For purposes of paragraph (18) of subsection (a), the term
`Inspector General' in section 1034 of such title 10 shall mean the
Inspector General of the Department of Health and Human Services.''.
SEC. 1130. COMPLIANCE DATE FOR RULE RELATING TO SUNSCREEN DRUG PRODUCTS
FOR OVER-THE-COUNTER HUMAN USE.
In accordance with the final rule issued by the Commissioner of
Food and Drug entitled ``Labeling and Effectiveness Testing; Sunscreen
Drug Products for Over-the-Counter Human Use; Delay of Compliance
Dates'' (77 Fed. Reg. 27591 (May 11, 2012)), a product subject to the
final rule issued by the Commissioner entitled ``Labeling and
Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter
Human Use'' (76 Fed. Reg. 35620 (June 17, 2011)), shall comply with
such rule not later than--
(1) December 17, 2013, for products subject to such rule with
annual sales of less than $25,000 and
(2) December 17, 2012, for all other products subject to such
rule.
SEC. 1131. STRATEGIC INTEGRATED MANAGEMENT PLAN.
Not later than 1 year after the date of enactment of this Act, the
Secretary of Health and Human Services shall submit to Congress a
strategic integrated management plan for the Center for Drug Evaluation
and Research, the Center for Biologics Evaluation and Research, and the
Center for Devices and Radiological Health. Such strategic management
plan shall--
(1) identify strategic institutional goals, priorities, and
mechanisms to improve efficiency, for the Center for Drug
Evaluation and Research, the Center for Biologics Evaluation and
Research, and the Center for Devices and Radiological Health;
(2) describe the actions the Secretary will take to recruit,
retain, train, and continue to develop the workforce at the Center
for Drug Evaluation and Research, the Center for Biologics
Evaluation and Research, and the Center for Devices and
Radiological Health to fulfill the public health mission of the
Food and Drug Administration; and
(3) identify results-oriented, outcome-based measures that the
Secretary will use to measure the progress of achieving the
strategic goals, priorities, and mechanisms identified under
paragraph (1) and the effectiveness of the actions identified under
paragraph (2), including metrics to ensure that managers and
reviewers of the Center for Drug Evaluation and Research, the
Center for Biologics Evaluation and Research, and the Center for
Devices and Radiological Health are familiar with and appropriately
and consistently apply the requirements under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), including new
requirements under parts 2, 3, 7, and 8 of subchapter C of title
VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et
seq.).
SEC. 1132. ASSESSMENT AND MODIFICATION OF REMS.
(a) Assessment and Modification of Approved Strategy.--Section 505-
1(g) (21 U.S.C. 355-1(g)) is amended--
(1) in paragraph (1), by striking ``, and propose a
modification to,'';
(2) in paragraph (2)--
(A) in the matter before subparagraph (A)--
(i) by striking ``, subject to paragraph (5),''; and
(ii) by striking ``, and may propose a modification
to,'';
(B) in subparagraph (C), by striking ``new safety or
effectiveness information indicates that'' and all that follows
and inserting the following: ``an assessment is needed to
evaluate whether the approved strategy should be modified to--
``(i) ensure the benefits of the drug outweigh the
risks of the drug; or
``(ii) minimize the burden on the health care delivery
system of complying with the strategy.''; and
(C) by striking subparagraph (D);
(3) in paragraph (3), by striking ``for a drug shall include--
'' and all that follows and inserting the following ``for a drug
shall include, with respect to each goal included in the strategy,
an assessment of the extent to which the approved strategy,
including each element of the strategy, is meeting the goal or
whether 1 or more such goals or such elements should be
modified.''; and
(4) by amending paragraph (4) to read as follows:
``(4) Modification.--
``(A) On initiative of responsible person.--After the
approval of a risk evaluation and mitigation strategy by the
Secretary, the responsible person may, at any time, submit to
the Secretary a proposal to modify the approved strategy. Such
proposal may propose the addition, modification, or removal of
any goal or element of the approved strategy and shall include
an adequate rationale to support such proposed addition,
modification, or removal of any goal or element of the
strategy.
``(B) On initiative of secretary.--After the approval of a
risk evaluation and mitigation strategy by the Secretary, the
Secretary may, at any time, require a responsible person to
submit a proposed modification to the strategy within 120 days
or within such reasonable time as the Secretary specifies, if
the Secretary, in consultation with the offices described in
subsection (c)(2), determines that 1 or more goals or elements
should be added, modified, or removed from the approved
strategy to--
``(i) ensure the benefits of the drug outweigh the
risks of the drug; or
``(ii) minimize the burden on the health care delivery
system of complying with the strategy.''.
(b) Review of Proposed Strategies; Review of Assessments and
Modifications of Approved Strategies.--Section 505-1(h) (21 U.S.C. 355-
1(h)) is amended--
(1) in the subsection heading by inserting ``and
Modifications'' after ``Review of Assessments'';
(2) in paragraph (1)--
(A) by inserting ``and proposed modification to'' after
``under subsection (a) and each assessment of''; and
(B) by inserting ``, and, if necessary, promptly initiate
discussions with the responsible person about such proposed
strategy, assessment, or modification'' after ``subsection
(g)'';
(3) by striking paragraph (2);
(4) by redesignating paragraphs (3) through (9) as paragraphs
(2) through (8), respectively;
(5) in paragraph (2), as redesignated by paragraph (4)--
(A) by amending subparagraph (A) to read as follows:
``(A) In general.--
``(i) Timeframe.--Unless the dispute resolution process
described under paragraph (3) or (4) applies, and, except
as provided in clause (ii) or clause (iii) below, the
Secretary, in consultation with the offices described in
subsection (c)(2), shall review and act on the proposed
risk evaluation and mitigation strategy for a drug or any
proposed modification to any required strategy within 180
days of receipt of the proposed strategy or modification.
``(ii) Minor modifications.--The Secretary shall review
and act on a proposed minor modification, as defined by the
Secretary in guidance, within 60 days of receipt of such
modification.
``(iii) REMS modification due to safety label
changes.--Not later than 60 days after the Secretary
receives a proposed modification to an approved risk
evaluation and mitigation strategy to conform the strategy
to approved safety label changes, including safety labeling
changes initiated by the sponsor in accordance with FDA
regulatory requirements, or to a safety label change that
the Secretary has directed the holder of the application to
make pursuant to section 505(o)(4), the Secretary shall
review and act on such proposed modification to the
approved strategy.
``(iv) Guidance.--The Secretary shall establish,
through guidance, that responsible persons may implement
certain modifications to an approved risk evaluation and
mitigation strategy following notification to the
Secretary.''; and
(B) by amending subparagraph (C) to read as follows:
``(C) Public availability.--Upon acting on a proposed risk
evaluation and mitigation strategy or proposed modification to
a risk evaluation and mitigation strategy under subparagraph
(A), the Secretary shall make publicly available an action
letter describing the actions taken by the Secretary under such
subparagraph (A).'';
(6) in paragraph (4), as redesignated by paragraph (4)--
(A) in subparagraph (A)(i)--
(i) by striking ``Not earlier than 15 days, and not
later than 35 days, after discussions under paragraph (2)
have begun, the'' and inserting ``The''; and
(ii) by inserting ``, after the sponsor is required to
make a submission under subsection (a)(2) or (g),'' before
``request in writing''; and
(B) in subparagraph (I)--
(i) by striking clauses (i) and (ii); and
(ii) by striking ``if the Secretary--'' and inserting
``if the Secretary has complied with the timing
requirements of scheduling review by the Drug Safety
Oversight Board, providing a written recommendation, and
issuing an action letter under subparagraphs (B), (F), and
(G), respectively.'';
(7) in paragraph (5), as redesignated by paragraph (4)--
(A) in subparagraph (A), by striking ``any of subparagraphs
(B) through (D)'' and inserting ``subparagraph (B) or (C)'';
and
(B) in subparagraph (C), by striking ``paragraph (4) or
(5)'' and inserting ``paragraph (3) or (4)''; and
(8) in paragraph (8), as redesignated by paragraph (4), by
striking ``paragraphs (7) and (8)'' and inserting ``paragraphs (6)
and (7).''.
(c) Guidance.--Not later than 1 year after the date of enactment of
this Act, the Secretary of Health and Human Services shall issue
guidance that, for purposes of section 505-1(h)(2)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(h)(2)(A)), describes the
types of modifications to approved risk evaluation and mitigation
strategies that shall be considered to be minor modifications of such
strategies.
SEC. 1133. EXTENSION OF PERIOD FOR FIRST APPLICANT TO OBTAIN TENTATIVE
APPROVAL WITHOUT FORFEITING 180-DAY-EXCLUSIVITY PERIOD.
(a) Extension.--
(1) In general.--If a first applicant files an application
during the 30-month period ending on the date of enactment of this
Act and such application initially contains a certification
described in paragraph (2)(A)(vii)(IV) of section 505(j) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), or if a
first applicant files an application and the application is amended
during such period to first contain such a certification, the
phrase ``30 months'' in paragraph (5)(D)(i)(IV) of such section
shall, with respect to such application, be read as meaning--
(A) during the period beginning on the date of enactment of
this Act, and ending on September 30, 2015, ``40 months''; and
(B) during the period beginning on October 1, 2015, and
ending on September 30, 2016, ``36 months''.
(2) Conforming amendment.--In the case of an application to
which an extended period under paragraph (1) applies, the reference
to the 30-month period under section 505(q)(1)(G) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(1)(G)) shall be read
to be the applicable period under paragraph (1).
(b) Period for Obtaining Tentative Approval of Certain
Applications.--If an application is filed on or before the date of
enactment of this Act and such application is amended during the period
beginning on the day after the date of enactment of this Act and ending
on September 30, 2017, to first contain a certification described in
paragraph (2)(A)(vii)(IV) of section 505(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)), the date of the filing of such
amendment (rather than the date of the filing of such application)
shall be treated as the beginning of the 30-month period described in
paragraph (5)(D)(i)(IV) of such section 505(j).
(c) Definitions.--For the purposes of this section, the terms
``application'' and ``first applicant'' mean application and first
applicant, as such terms are used in section 505(j)(5)(D)(i)(IV) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(IV)).
SEC. 1134. DEADLINE FOR DETERMINATION ON CERTAIN PETITIONS.
(a) In General.--Section 505 (21 U.S.C. 355) is amended by adding
at the end the following:
``(w) Deadline for Determination on Certain Petitions.--The
Secretary shall issue a final, substantive determination on a petition
submitted pursuant to subsection (b) of section 314.161 of title 21,
Code of Federal Regulations (or any successor regulations), no later
than 270 days after the date the petition is submitted.''.
(b) Application.--The amendment made by subsection (a) shall apply
to any petition that is submitted pursuant to subsection (b) of section
314.161 of title 21, Code of Federal Regulations (or any successor
regulations), on or after the date of enactment of this Act.
SEC. 1135. FINAL AGENCY ACTION RELATING TO PETITIONS AND CIVIL ACTIONS.
Section 505(q) (21 U.S.C. 355(q)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A), by striking ``subsection (b)(2) or
(j)'' and inserting ``subsection (b)(2) or (j) of this section
or section 351(k) of the Public Health Service Act''; and
(B) in subparagraph (F), by striking ``180 days'' and
inserting ``150 days'';
(2) in paragraph (2)(A)--
(A) in the subparagraph heading, by striking ``180'' and
inserting ``150''; and
(B) in clause (i), by striking ``180-day'' and inserting
``150-day'';
(3) in paragraph (4)--
(A) by redesignating subparagraphs (A) and (B) as clauses
(i) and (ii), respectively, and moving such clauses, as so
redesignated, 2 ems to the right;
(B) by striking ``This subsection does not apply to--'' and
inserting the following:
``(A) This subsection does not apply to--''; and
(C) by adding at the end the following:
``(B) Paragraph (2) does not apply to a petition addressing
issues concerning an application submitted pursuant to section
351(k) of the Public Health Service Act.''; and
(4) in paragraph (5), by striking ``subsection (b)(2) or (j)''
inserting ``subsection (b)(2) or (j) of the Act or 351(k) of the
Public Health Service Act''.
SEC. 1136. ELECTRONIC SUBMISSION OF APPLICATIONS.
Subchapter D of chapter VII (21 U.S.C. 379k et seq.) is amended by
inserting after section 745 the following:
``SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS.
``(a) Drugs and Biologics.--
``(1) In general.--Beginning no earlier than 24 months after
the issuance of a final guidance issued after public notice and
opportunity for comment, submissions under subsection (b), (i), or
(j) of section 505 of this Act or subsection (a) or (k) of section
351 of the Public Health Service Act shall be submitted in such
electronic format as specified by the Secretary in such guidance.
``(2) Guidance contents.--In the guidance under paragraph (1),
the Secretary may--
``(A) provide a timetable for establishment by the
Secretary of further standards for electronic submission as
required by such paragraph; and
``(B) set forth criteria for waivers of and exemptions from
the requirements of this subsection.
``(3) Exception.--This subsection shall not apply to
submissions described in section 561.
``(b) Devices.--
``(1) In general.--Beginning after the issuance of final
guidance implementing this paragraph, presubmissions and
submissions for devices under section 510(k), 513(f)(2)(A), 515(c),
515(d), 515(f), 520(g), 520(m), or 564 of this Act or section 351
of the Public Health Service Act, and any supplements to such
presubmissions or submissions, shall include an electronic copy of
such presubmissions or submissions.
``(2) Guidance contents.--In the guidance under paragraph (1),
the Secretary may--
``(A) provide standards for the electronic copy required
under such paragraph; and
``(B) set forth criteria for waivers of and exemptions from
the requirements of this subsection.''.
SEC. 1137. PATIENT PARTICIPATION IN MEDICAL PRODUCT DISCUSSIONS.
Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as amended by
section 1123 of this Act, is further amended by adding at the end the
following:
``SEC. 569C. PATIENT PARTICIPATION IN MEDICAL PRODUCT DISCUSSION.
``(a) In General.--The Secretary shall develop and implement
strategies to solicit the views of patients during the medical product
development process and consider the perspectives of patients during
regulatory discussions, including by--
``(1) fostering participation of a patient representative who
may serve as a special government employee in appropriate agency
meetings with medical product sponsors and investigators; and
``(2) exploring means to provide for identification of patient
representatives who do not have any, or have minimal, financial
interests in the medical products industry.
``(b) Protection of Proprietary Information.--Nothing in this
section shall be construed to alter the protections offered by laws,
regulations, or policies governing disclosure of confidential
commercial or trade secret information and any other information exempt
from disclosure pursuant to section 552(b) of title 5, United States
Code, as such laws, regulations, or policies would apply to
consultation with individuals and organizations prior to the date of
enactment of this section.
``(c) Other Consultation.--Nothing in this section shall be
construed to limit the ability of the Secretary to consult with
individuals and organizations as authorized prior to the date of
enactment of this section.
``(d) No Right or Obligation.--Nothing in this section shall be
construed to create a legal right for a consultation on any matter or
require the Secretary to meet with any particular expert or
stakeholder. Nothing in this section shall be construed to alter agreed
upon goals and procedures identified in the letters described in
section 101(b) of the Prescription Drug User Fee Amendments of 2012.
Nothing in this section is intended to increase the number of review
cycles as in effect before the date of enactment of this section.
``(e) Financial Interest.--In this section, the term `financial
interest' means a financial interest under section 208(a) of title 18,
United States Code.''.
SEC. 1138. ENSURING ADEQUATE INFORMATION REGARDING PHARMACEUTICALS FOR
ALL POPULATIONS, PARTICULARLY UNDERREPRESENTED SUBPOPULATIONS,
INCLUDING RACIAL SUBGROUPS.
(a) Communication Plan.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), acting through the
Commissioner of Food and Drugs, shall review and modify, as necessary,
the Food and Drug Administration's communication plan to inform and
educate health care providers and patients on the benefits and risks of
medical products, with particular focus on underrepresented
subpopulations, including racial subgroups.
(b) Content.--The communication plan described under subsection
(a)--
(1) shall take into account--
(A) the goals and principles set forth in the Strategic
Action Plan to Reduce Racial and Ethnic Health Disparities
issued by the Department of Health and Human Services;
(B) the nature of the medical product; and
(C) health and disease information available from other
agencies within such Department, as well as any new means of
communicating health and safety benefits and risks related to
medical products;
(2) taking into account the nature of the medical product,
shall address the best strategy for communicating safety alerts,
labeled indications for the medical products, changes to the label
or labeling of medical products (including black-box warnings,
health advisories, health and safety benefits and risks),
particular actions to be taken by health care professionals and
patients, any information identifying particular subpopulations,
and any other relevant information as determined appropriate to
enhance communication, including varied means of electronic
communication; and
(3) shall include a process for implementation of any
improvements or other modifications determined to be necessary.
(c) Issuance and Posting of Communication Plan.--
(1) Communication plan.--Not later than 1 year after the date
of enactment of this Act, the Secretary, acting through the
Commissioner of Food and Drugs, shall issue the communication plan
described under this section.
(2) Posting of communication plan on the office of minority
health web site.--The Secretary, acting through the Commissioner of
Food and Drugs, shall publicly post the communication plan on the
Internet Web site of the Office of Minority Health of the Food and
Drug Administration, and provide links to any other appropriate
Internet Web site, and seek public comment on the communication
plan.
SEC. 1139. SCHEDULING OF HYDROCODONE.
(a) In General.--Not later than 60 days after the date of enactment
of this Act, if practicable, the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall hold a public
meeting to solicit advice and recommendations to assist in conducting a
scientific and medical evaluation in connection with a scheduling
recommendation to the Drug Enforcement Administration regarding drug
products containing hydrocodone, combined with other analgesics or as
an antitussive.
(b) Stakeholder Input.--In conducting the evaluation under
subsection (a), the Secretary shall solicit input from a variety of
stakeholders including patients, health care providers, harm prevention
experts, the National Institute on Drug Abuse, the Centers for Disease
Control and Prevention, and the Drug Enforcement Administration
regarding the health benefits and risks, including the potential for
abuse and the impact of up-scheduling of these products.
(c) Transcript.--The transcript of any public meeting conducted
pursuant to this section shall be published on the Internet Web site of
the Food and Drug Administration.
SEC. 1140. STUDY ON DRUG LABELING BY ELECTRONIC MEANS.
(a) Study.--The Comptroller General of the United States shall
conduct a study on the benefits and efficiencies of electronic patient
labeling of prescription drugs, as a complete or partial substitute for
patient labeling in paper form. The study shall address the
implementation costs to the different levels of the distribution
system, logistical barriers to utilizing a system of electronic patient
labeling, and any anticipated public health impact of movement to
electronic labeling.
(b) Report.--Not later than 1 year after the date of enactment of
this Act, the Comptroller General shall submit to Congress a report on
the results of the study under subsection (a).
SEC. 1141. RECOMMENDATIONS ON INTEROPERABILITY STANDARDS.
(a) In General.--The Secretary of Health and Human Services may
facilitate, and, as appropriate, may consult with the Attorney General
to facilitate, the development of recommendations on interoperability
standards to inform and facilitate the exchange of prescription drug
information across State lines by States receiving grant funds under--
(1) the Harold Rogers Prescription Drug Monitoring Program
established under the Departments of Commerce, Justice, and State,
the Judiciary, and Related Agencies Appropriations Act, 2002
(Public Law 107-77; 115 Stat. 748); and
(2) the Controlled Substance Monitoring Program established
under section 399O of the Public Health Service Act (42 U.S.C.
280g-3).
(b) Requirements.--The Secretary of Health and Human Services shall
consider the following in facilitating the development of
recommendations on interoperability of prescription drug monitoring
programs under subsection (a)--
(1) open standards that are freely available, without cost and
without restriction, in order to promote broad implementation;
(2) the use of exchange intermediaries, or hubs, as necessary
to facilitate interstate interoperability by accommodating State-
to-hub, hub-to-hub, and direct State-to-State communication;
(3) the support of transmissions that are fully secured as
required, using industry standard methods of encryption, to ensure
that protected health information and personally identifiable
information are not compromised at any point during such
transmission;
(4) access control methodologies to share protected information
solely in accordance with State laws and regulations; and
(5) consider model interoperability standards developed by the
Alliance of States with Prescription Monitoring Programs.
(c) Report.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services
shall submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of
the House of Representatives a report on enhancing the
interoperability of State prescription drug monitoring programs
with other technologies and databases used for detecting and
reducing fraud, diversion, and abuse of prescription drugs.
(2) Contents.--The report required under paragraph (1) shall
include--
(A) an assessment of legal, technical, fiscal, privacy, or
security challenges that have an impact on interoperability;
(B) a discussion of how State prescription drug monitoring
programs could increase the production and distribution of
unsolicited reports to prescribers and dispensers of
prescription drugs, law enforcement officials, and health
professional licensing agencies, including the enhancement of
such reporting through interoperability with other States and
relevant technology and databases;
(C) any recommendations for addressing challenges that
impact interoperability of State prescription drug monitoring
programs in order to reduce fraud, diversion, and abuse of
prescription drugs; and
(D) an assessment of the extent to which providers use
prescription drug management programs in delivering care and
preventing prescription drug abuse.
SEC. 1142. CONFLICTS OF INTEREST.
(a) In General.--Section 712 (21 U.S.C. 379d-1) is amended--
(1) by striking subsections (b) and (c) and inserting the
following subsections:
``(b) Recruitment for Advisory Committees.--
``(1) In general.--The Secretary shall--
``(A) develop and implement strategies on effective
outreach to potential members of advisory committees at
universities, colleges, other academic research centers,
professional and medical societies, and patient and consumer
groups;
``(B) seek input from professional medical and scientific
societies to determine the most effective informational and
recruitment activities;
``(C) at least every 180 days, request referrals for
potential members of advisory committees from a variety of
stakeholders, including--
``(i) product developers, patient groups, and disease
advocacy organizations; and
``(ii) relevant--
``(I) professional societies;
``(II) medical societies;
``(III) academic organizations; and
``(IV) governmental organizations; and
``(D) in carrying out subparagraphs (A) and (B), take into
account the levels of activity (including the numbers of annual
meetings) and the numbers of vacancies of the advisory
committees.
``(2) Recruitment activities.--The recruitment activities under
paragraph (1) may include--
``(A) advertising the process for becoming an advisory
committee member at medical and scientific society conferences;
``(B) making widely available, including by using existing
electronic communications channels, the contact information for
the Food and Drug Administration point of contact regarding
advisory committee nominations; and
``(C) developing a method through which an entity receiving
funding from the National Institutes of Health, the Agency for
Healthcare Research and Quality, the Centers for Disease
Control and Prevention, or the Veterans Health Administration
can identify a person whom the Food and Drug Administration can
contact regarding the nomination of individuals to serve on
advisory committees.
``(3) Expertise.--In carrying out this subsection, the
Secretary shall seek to ensure that the Secretary has access to the
most current expert advice.
``(c) Disclosure of Determinations and Certifications.--
Notwithstanding section 107(a)(2) of the Ethics in Government Act of
1978, the following shall apply:
``(1) 15 or more days in advance.--As soon as practicable, but
(except as provided in paragraph (2)) not later than 15 days prior
to a meeting of an advisory committee to which a written
determination as referred to in section 208(b)(1) of title 18,
United States Code, or a written certification as referred to in
section 208(b)(3) of such title, applies, the Secretary shall
disclose (other than information exempted from disclosure under
section 552 or section 552a of title 5, United States Code
(popularly known as the Freedom of Information Act and the Privacy
Act of 1974, respectively)) on the Internet Web site of the Food
and Drug Administration--
``(A) the type, nature, and magnitude of the financial
interests of the advisory committee member to which such
determination or certification applies; and
``(B) the reasons of the Secretary for such determination
or certification, including, as appropriate, the public health
interest in having the expertise of the member with respect to
the particular matter before the advisory committee.
``(2) Less than 30 days in advance.--In the case of a financial
interest that becomes known to the Secretary less than 30 days
prior to a meeting of an advisory committee to which a written
determination as referred to in section 208(b)(1) of title 18,
United States Code, or a written certification as referred to in
section 208(b)(3) of such title applies, the Secretary shall
disclose (other than information exempted from disclosure under
section 552 or 552a of title 5, United States Code) on the Internet
Web site of the Food and Drug Administration, the information
described in subparagraphs (A) and (B) of paragraph (1) as soon as
practicable after the Secretary makes such determination or
certification, but in no case later than the date of such
meeting.'';
(2) in subsection (d), by striking ``subsection (c)(3)'' and
inserting ``subsection (c)'';
(3) by amending subsection (e) to read as follows:
``(e) Annual Report.--
``(1) In general.--Not later than February 1 of each year, the
Secretary shall submit to the Committee on Appropriations and the
Committee on Health, Education, Labor, and Pensions of the Senate,
and the Committee on Appropriations and the Committee on Energy and
Commerce of the House of Representatives, a report that describes--
``(A) with respect to the fiscal year that ended on
September 30 of the previous year, the number of persons
nominated for participation at meetings for each advisory
committee, the number of persons so nominated, and willing to
serve, the number of vacancies on each advisory committee, and
the number of persons contacted for service as members on each
advisory committee meeting for each advisory committee who did
not participate because of the potential for such participation
to constitute a disqualifying financial interest under section
208 of title 18, United States Code;
``(B) with respect to such year, the number of persons
contacted for services as members for each advisory committee
meeting for each advisory committee who did not participate
because of reasons other than the potential for such
participation to constitute a disqualifying financial interest
under section 208 of title 18, United States Code;
``(C) with respect to such year, the number of members
attending meetings for each advisory committee; and
``(D) with respect to such year, the aggregate number of
disclosures required under subsection (d) and the percentage of
individuals to whom such disclosures did not apply who served
on such committee.
``(2) Public availability.--Not later than 30 days after
submitting any report under paragraph (1) to the committees
specified in such paragraph, the Secretary shall make each such
report available to the public.'';
(4) in subsection (f), by striking ``shall review guidance''
and all that follows through the end of the subsection and
inserting the following: ``shall--
``(1) review guidance of the Food and Drug Administration with
respect to advisory committees regarding disclosure of conflicts of
interest and the application of section 208 of title 18, United
States Code; and
``(2) update such guidance as necessary to ensure that the Food
and Drug Administration receives appropriate access to needed
scientific expertise, with due consideration of the requirements of
such section 208.''; and
(5) by adding at the end the following:
``(g) Guidance on Reported Disclosed Financial Interest or
Involvement.--The Secretary shall issue guidance that describes how the
Secretary reviews the financial interests and involvement of advisory
committee members that are disclosed under subsection (c) but that the
Secretary determines not to meet the definition of a disqualifying
interest under section 208 of title 18, United States Code for the
purposes of participating in a particular matter.''.
(b) Applicability.--The amendments made by subsection (a) apply
beginning on October 1, 2012.
SEC. 1143. NOTIFICATION OF FDA INTENT TO REGULATE LABORATORY-DEVELOPED
TESTS.
(a) In General.--The Food and Drug Administration may not issue any
draft or final guidance on the regulation of laboratory-developed tests
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
without, at least 60 days prior to such issuance--
(1) notifying the Committee on Energy and Commerce of the House
of Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate of the Administration's intent to take
such action; and
(2) including in such notification the anticipated details of
such action.
(b) Sunset.--Subsection (a) shall cease to have force or effect on
the date that is 5 years after the date of enactment of this Act.
Subtitle D--Synthetic Drugs
SEC. 1151. SHORT TITLE.
This subtitle may be cited as the ``Synthetic Drug Abuse Prevention
Act of 2012''.
SEC. 1152. ADDITION OF SYNTHETIC DRUGS TO SCHEDULE I OF THE CONTROLLED
SUBSTANCES ACT.
(a) Cannabimimetic Agents.--Schedule I, as set forth in section
202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) is amended
by adding at the end the following:
``(d)(1) Unless specifically exempted or unless listed in another
schedule, any material, compound, mixture, or preparation which
contains any quantity of cannabimimetic agents, or which contains their
salts, isomers, and salts of isomers whenever the existence of such
salts, isomers, and salts of isomers is possible within the specific
chemical designation.
``(2) In paragraph (1):
``(A) The term `cannabimimetic agents' means any substance that
is a cannabinoid receptor type 1 (CB1 receptor) agonist as
demonstrated by binding studies and functional assays within any of
the following structural classes:
``(i) 2-(3-hydroxycyclohexyl)phenol with substitution at
the 5-position of the phenolic ring by alkyl or alkenyl,
whether or not substituted on the cyclohexyl ring to any
extent.
``(ii) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole
by substitution at the nitrogen atom of the indole ring,
whether or not further substituted on the indole ring to any
extent, whether or not substituted on the naphthoyl or naphthyl
ring to any extent.
``(iii) 3-(1-naphthoyl)pyrrole by substitution at the
nitrogen atom of the pyrrole ring, whether or not further
substituted in the pyrrole ring to any extent, whether or not
substituted on the naphthoyl ring to any extent.
``(iv) 1-(1-naphthylmethylene)indene by substitution of the
3-position of the indene ring, whether or not further
substituted in the indene ring to any extent, whether or not
substituted on the naphthyl ring to any extent.
``(v) 3-phenylacetylindole or 3-benzoylindole by
substitution at the nitrogen atom of the indole ring, whether
or not further substituted in the indole ring to any extent,
whether or not substituted on the phenyl ring to any extent.
``(B) Such term includes--
``(i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-
hydroxycyclohexyl]-phenol (CP-47,497);
``(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-
hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-
homolog);
``(iii) 1-pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678);
``(iv) 1-butyl-3-(1-naphthoyl)indole (JWH-073);
``(v) 1-hexyl-3-(1-naphthoyl)indole (JWH-019);
``(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole
(JWH-200);
``(vii) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250);
``(viii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-
081);
``(ix) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122);
``(x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398);
``(xi) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201);
``(xii) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694);
``(xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19 and
RCS-4);
``(xiv) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole
(SR-18 and RCS-8); and
``(xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-
203).''.
(b) Other Drugs.--Schedule I of section 202(c) of the Controlled
Substances Act (21 U.S.C. 812(c)) is amended in subsection (c) by
adding at the end the following:
``(18) 4-methylmethcathinone (Mephedrone).
``(19) 3,4-methylenedioxypyrovalerone (MDPV).
``(20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E).
``(21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D).
``(22) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).
``(23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I).
``(24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-
2).
``(25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-
T-4).
``(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).
``(27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N).
``(28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-
P).''.
SEC. 1153. TEMPORARY SCHEDULING TO AVOID IMMINENT HAZARDS TO PUBLIC
SAFETY EXPANSION.
Section 201(h)(2) of the Controlled Substances Act (21 U.S.C.
811(h)(2)) is amended--
(1) by striking ``one year'' and inserting ``2 years''; and
(2) by striking ``six months'' and inserting ``1 year''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.