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Text - S.3187 - 112th Congress (2011-2012): Food and Drug Administration Safety and Innovation Act | Congress.gov | Library of Congress Loc.gov
Home > Legislation > 112th Congress > S.3187 S.3187 - Food and Drug Administration Safety and Innovation Act112th Congress (2011-2012) Law
Sen. Harkin, Tom [D-IA] (Introduced 05/15/2012) Cosponsors:1Latest Action:07/09/2012 Became Public Law No: 112-144.Major Recorded Votes:06/26/2012 : Resolving Differences; 05/24/2012 : Passed SenateTracker:This bill has the status Became LawHere are the steps for Status of Legislation:IntroducedArray
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Text: S.3187 — 112th Congress (2011-2012)07/09/2012 Became Public Law No: 112-144TXTPDF
There are 4 versions of the bill: Enrolled Bill (06/27/2012)Engrossed Amendment House (06/20/2012)Engrossed in Senate (05/24/2012)Placed on Calendar Senate (05/16/2012) Bill text available as:TXTPDFHTML/XML
Shown Here:Enrolled Bill (06/27/2012)
[S. 3187 Enrolled Bill (ENR)]
the user-fee programs for prescription drugs and medical devices, to
establish user-fee programs for generic drugs and biosimilars, and for
This Act may be cited as the ``Food and Drug Administration Safety
and Innovation Act''.
(a) Table of Contents.--The table of contents of this Act is as
Sec. 208. Streamlined hiring authority to support activities related to
Sec. 307. Streamlined hiring authority to support activities related to
human generic drugs.
Sec. 308. Additional reporting requirements.
Sec. 408. Additional reporting requirements.
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.
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
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. 619. Good guidance practices relating to devices.
Sec. 620. Pediatric device consortia.
Sec. 701. Registration of domestic drug establishments.
Sec. 702. Registration of foreign establishments.
Sec. 703. Identification of drug excipient information with product
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
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. 714. Registration of commercial importers.
Sec. 715. Notification.
Sec. 716. Protection against intentional adulteration.
Sec. 717. Penalties for counterfeiting drugs.
Sec. 718. Extraterritorial jurisdiction.
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.
Sec. 901. Enhancement of accelerated patient access to new medical
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. 907. Reporting of inclusion of demographic subgroups in clinical
trials and data analysis in applications for drugs, biologics,
Sec. 908. Rare pediatric disease priority review voucher incentive
Sec. 1001. Discontinuance or interruption in the production of life-
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.
Sec. 1101. Reauthorization of provision relating to exclusivity of
certain drugs containing single enantiomers.
Sec. 1102. Reauthorization of the critical path public-private
Sec. 1111. Regulation of medical gases.
Sec. 1112. Changes to regulations.
Sec. 1113. Rules of construction.
Sec. 1121. Guidance document regarding product promotion using the
Sec. 1122. Combating prescription drug abuse.
Sec. 1123. Optimizing global clinical trials.
Sec. 1124. Advancing regulatory science to promote public health
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
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
Sec. 1152. Addition of synthetic drugs to schedule I of the Controlled
Sec. 1153. Temporary scheduling to avoid imminent hazards to public
safety expansion.
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
Representatives, as set forth in the Congressional Record.
Section 735(7) (21 U.S.C. 379g) is amended by striking ``expenses
incurred in connection with'' and inserting ``expenses in connection
Section 736 (21 U.S.C. 379h) is amended--
``fiscal year 2008'' and inserting ``fiscal year 2013'';
(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
(i) by striking ``(c)(5)'' and inserting ``(c)(4)'';
(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
(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
``(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
1984.'';
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
``(B) the dollar amount equal to the inflation adjustment
for fiscal year 2013 (as determined under paragraph (3)(A));
``(C) the dollar amount equal to the workload adjustment
for fiscal year 2013 (as determined under paragraph (3)(B)).'';
(B) by striking paragraphs (3) and (4) and inserting the
``(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
``(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
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).'';
``(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
``(A) one;
``(B) the average annual percent change in the cost, per
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
``(C) the average annual percent change that occurred in
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
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
``(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
``(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
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
``(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
process for the review of human drug applications.''; and
(A) in paragraph (1), by striking ``Fees authorized'' and
inserting ``Subject to paragraph (2)(C), fees authorized'';
(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
``(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
(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''.
Section 736B (21 U.S.C. 379h-2) is amended--
``(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
``(A) the progress of the Food and Drug Administration 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;
``(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
``(iii) the number of standard efficacy supplements
filed per fiscal year for each review division;
``(iv) the number of priority efficacy supplements
``(v) the number of applications filed for review under
accelerated approval per fiscal year for each review
``(vi) the number of applications filed for review as
fast track products per fiscal year for each review
``(vii) the number of applications filed for orphan-
designated products per fiscal year for each review
``(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
(3) in subsection (d), by striking ``2012'' each place it
(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
(b) Reporting Requirements.--Section 736B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease to be effective
(c) Previous Sunset Provision.--
(1) In general.--Section 106 of the Food and Drug
Administration Amendments Act of 2007 (Public Law 110-85) is
(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
(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
(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
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
Notwithstanding the amendments made by this title, part 2 of
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.
(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
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.''.
(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'';
(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
(B) in clause (viii), by striking ``1.84'' and inserting
(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
(b) Fee Amounts.--Section 738(b) (21 U.S.C. 379j(b)) is amended to
``(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
``(2) Base fee amounts specified.--For purposes of paragraph
(1), the base fee amounts specified in this paragraph are as
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
``(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)
(4) by inserting before paragraph (4), as so redesignated, the
``(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
``(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
``(B) Applicable inflation adjustment to total revenue
amounts.--The applicable inflation adjustment for a fiscal year
``(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
``(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
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
``(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
``(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
(1) redesignating subsections (f) through (k) as subsections
(g) through (l), respectively; and
``(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
(i) in clause (i), by striking ``shall be retained''
and inserting ``subject to subparagraph (C), shall be
collected and available''; and
(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:
``(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
(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)''.
(a) Reauthorization.--Section 738A(b) (21 U.S.C. 379j-1(b)) is
(1) in paragraph (1), by striking ``2012'' and inserting
(2) in paragraph (5), by striking ``2012'' and inserting
(b) Performance Reports.--Section 738A(a) (21 U.S.C. 379j-1(a)) is
``(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
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
``(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
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
``(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''.
Notwithstanding the amendments made by this title, part 3 of
(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.
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
(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.
(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
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
``(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
(a) Short Title.--This title may be cited as the ``Generic Drug
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
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
Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by
``PART 7--FEES RELATING TO GENERIC DRUGS
``SEC. 744A. DEFINITIONS.
``(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
``(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
``(A) one business entity controls, or has the power to
``(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;
``(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;
``(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
``(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
``(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
``(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
``(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
``(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
``(ii) Developing and using improved adverse-event
data-collection systems, including information technology
``(iii) Developing and using improved analytical tools
to assess potential safety problems, including access to
``(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
``(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
``(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--
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
``(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
``(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
``(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
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.
``(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
``(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
``(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
``(II) the drug master file has not failed an
initial completeness assessment by the Secretary, in
accordance with criteria to be published by the
``(iii) List.--The Secretary shall make publicly
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
``(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).
notice announcing the amount of the fees under subparagraph
(A) for fiscal year 2013.
``(ii) Fiscal years 2014 through 2017.--Not later than
Register the amount of the fees under subparagraph (A) for
``(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
``(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
``(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
``(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
``(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),
``(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
``(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
``(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
``(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
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
``(iii) Facilities producing both active pharmaceutical
ingredients and finished dosage forms.--Each person that
owns a facility identified, or intended to be identified,
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).
``(i) Fiscal year 2013.--For fiscal year 2013, the
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
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
and obligation of fees under this section for such
``(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
``(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
``(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
``(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
Federal Register, for a fiscal year, by an amount equal to the sum
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
of human generic drug activities for the first 3 years of the
The adjustment made each fiscal year under this subsection shall be
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
carryover balances for such activities in excess of 3 months of
such operating reserves, the adjustment under this subparagraph
``(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
``(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
``(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
``(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);
``(B) for each subsequent fiscal year, be submitted,
updated, or reconfirmed on or before June 1 of the previous
``(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
``(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
``(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
``(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
``(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.
``(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
``(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
pharmaceutical ingredient drug master file to pay the
``(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
``(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
``(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
``(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
``(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
``(ii) Nonreceival.--If the facility fee is not paid
notification under clause