[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 3187 Engrossed Amendment House (EAH)]
In the House of Representatives, U. S.,
June 20, 2012.
Resolved, That the bill from the Senate (S. 3187) entitled ``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.'', do pass with the following
AMENDMENT:
Strike out all after the enacting clause and insert:
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-serf 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''.
Attest:
Clerk.
112th CONGRESS
2d Session
S. 3187
_______________________________________________________________________
AMENDMENT