1.This Act may be cited as the
Food and Drug Administration Safety
and Innovation Act
.
2.Table of contents; references in
Act
(a)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)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.).
<enum>I</enum><header display-inline="yes-display-inline">Fees relating to drugs</header>
<section commented="no" display-inline="no-display-inline" id="HDE45BD6B01CC4A38A96162822D919218" section-type="subsequent-section"><enum>101.</enum><header display-inline="yes-display-inline">Short title; finding</header>
<subsection commented="no" display-inline="no-display-inline" id="HC74A537D4920431F9812C3919C906917"><enum>(a)</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="yes-display-inline">This title may be cited as the
<quote><short-title>Prescription Drug User Fee Amendments
of 2012</short-title></quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H17B4992075A14155B9DB4E614B0BEA14"><enum>(b)</enum><header display-inline="yes-display-inline">Finding</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HF78D773DDD1C414CA8E832B89386D5A5" section-type="subsequent-section"><enum>102.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">Section 735(7) (21 U.S.C. 379g) is amended
by striking <quote>expenses incurred in connection with</quote> and inserting
<quote>expenses in connection with</quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="HA262D5744788440698B1C4559E5DF8EA" section-type="subsequent-section"><enum>103.</enum><header display-inline="yes-display-inline">Authority to assess and use drug
fees</header><text display-inline="no-display-inline">Section 736 (21 U.S.C.
379h) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HA7462646FCFF42FA8DF40377E17C6FEF"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H1864FF40F92F4B7E9F2DB4B64A823926"><enum>(A)</enum><text display-inline="yes-display-inline">in the matter preceding paragraph (1), by
striking <quote>fiscal year 2008</quote> and inserting <quote>fiscal year
2013</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD7CBD7BA6AA149D1B9FFA6EF455AF61D"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1)(A)—</text>
<clause commented="no" display-inline="no-display-inline" id="HE7EA93EE46BB48E697D46AA3E5A08203"><enum>(i)</enum><text display-inline="yes-display-inline">in clause (i), by striking
<quote>(c)(5)</quote> and inserting <quote>(c)(4)</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H79CE10A434D945ADBA41E8762F9EE680"><enum>(ii)</enum><text display-inline="yes-display-inline">in clause (ii), by striking
<quote>(c)(5)</quote> and inserting <quote>(c)(4)</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7FC8D43BE50B4108A7AD95A4419EFE63"><enum>(C)</enum><text display-inline="yes-display-inline">in the matter following clause (ii) in
paragraph (2)(A)—</text>
<clause commented="no" display-inline="no-display-inline" id="H9909DBC4EE854693A0A624EF7BFAA1E3"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>(c)(5)</quote> and
inserting <quote>(c)(4)</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H97944C98DD0647D983756FDDA3C27E1D"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>payable on or before
October 1 of each year</quote> and inserting <quote>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</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2593B7A1E716475282ACCC23A27CFE7F"><enum>(D)</enum><text display-inline="yes-display-inline">in paragraph (3)—</text>
<clause commented="no" display-inline="no-display-inline" id="HD86A7D3FDFB44761825B830FFE83E2E5"><enum>(i)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text>
<subclause commented="no" display-inline="no-display-inline" id="HEAC89834275945C5867359E1EE310E94"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>subsection
(c)(5)</quote> and inserting <quote>subsection (c)(4)</quote>; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H543D5302993442ABB178C4EDCCFEA22A"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>payable on or before
October 1 of each year.</quote> and inserting <quote>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.</quote>; and</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H1CEEB2CA3AFE4A9B8F19B37D17FD6698"><enum>(ii)</enum><text display-inline="yes-display-inline">by amending subparagraph (B) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="H91E9312404094B3F853EB2024FCE73BA" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H8CBA2FF760974AF0810C51E4FE358A83"><enum>(B)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">A prescription drug product shall not be
assessed a fee under subparagraph (A) if such product is—</text>
<clause commented="no" display-inline="no-display-inline" id="H9A8F1362AD594C36BB9D7E0E3544B903"><enum>(i)</enum><text display-inline="yes-display-inline">identified on the list compiled under
section 505(j)(7) with a potency described in terms of per 100 mL;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H03FD33606FDB40D19E61BFA29FA93352"><enum>(ii)</enum><text display-inline="yes-display-inline">the same product as another product
that—</text>
<subclause commented="no" display-inline="no-display-inline" id="HAB30148346114A4B901AB0707DC1DEBA"><enum>(I)</enum><text display-inline="yes-display-inline">was approved under an application filed
under section 505(b) or 505(j); and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HEEEE68A19EEC47BE9753F0348C082E86"><enum>(II)</enum><text display-inline="yes-display-inline">is not in the list of discontinued products
compiled under section 505(j)(7);</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="HB6E6A36DE9F54FF0807BD1D97E684DA6"><enum>(iii)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H3884550C16C143329909B110EDE9AC2C"><enum>(iv)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H69881F4FC34C4D6DB16D44D5096C331A"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H1EC4B9620473438BAC9FFE3C6F19B963"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<clause commented="no" display-inline="no-display-inline" id="H5B55BE4B145D4A6BA32F61A80B7F6E70"><enum>(i)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph (A),
by striking <quote>fiscal years 2008 through 2012</quote> and inserting
<quote>fiscal years 2013 through 2017</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HAB508DBF3412470E9AC5A5F822D0A132"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking
<quote>$392,783,000; and</quote> and inserting <quote>$693,099,000;</quote>;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HDD3DC8E42C2B4FBBA111C81F781DF29A"><enum>(iii)</enum><text display-inline="yes-display-inline">by striking subparagraph (B) and inserting
the following:</text>
<quoted-block display-inline="no-display-inline" id="HF0AFC39E0E944B2E923B3CA4A9BC2EB6" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H8DE6191418144A338BCECF3E6B83EC50"><enum>(B)</enum><text display-inline="yes-display-inline">the dollar amount equal to the inflation
adjustment for fiscal year 2013 (as determined under paragraph (3)(A));
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC00DA29015D34713A53C3BD84886EA66"><enum>(C)</enum><text display-inline="yes-display-inline">the dollar amount equal to the workload
adjustment for fiscal year 2013 (as determined under paragraph
(3)(B)).</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF8E3EF2222EB49E784BB705CD18828A6"><enum>(B)</enum><text display-inline="yes-display-inline">by striking paragraphs (3) and (4) and
inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="HFBBFBD164F2A47A5B2A7003C6941FFE1" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="HA997A2B6DE634135B5F1424D001514D8"><enum>(3)</enum><header display-inline="yes-display-inline">Fiscal year 2013 inflation and workload
adjustments</header><text display-inline="yes-display-inline">For purposes of
paragraph (1), the dollar amount of the inflation and workload adjustments for
fiscal year 2013 shall be determined as follows:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HC2B147BB1E674643BB08776FF303852F"><enum>(A)</enum><header display-inline="yes-display-inline">Inflation adjustment</header><text display-inline="yes-display-inline">The inflation adjustment for fiscal year
2013 shall be the sum of—</text>
<clause commented="no" display-inline="no-display-inline" id="HCC8F7DF015E74F51976B20394E1444E9"><enum>(i)</enum><text display-inline="yes-display-inline">$652,709,000 multiplied by the result of an
inflation adjustment calculation determined using the methodology described in
subsection (c)(1)(B); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HFA4926D68E2A4B41857E41693A3C81B1"><enum>(ii)</enum><text display-inline="yes-display-inline">$652,709,000 multiplied by the result of an
inflation adjustment calculation determined using the methodology described in
subsection (c)(1)(C).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEF5C2B809FAB415FAE67FAEA48547E24"><enum>(B)</enum><header display-inline="yes-display-inline">Workload adjustment</header><text display-inline="yes-display-inline">Subject to subparagraph (C), the workload
adjustment for fiscal 2013 shall be—</text>
<clause commented="no" display-inline="no-display-inline" id="H11BA337DF279429BA8EC3A5FA748CAFC"><enum>(i)</enum><text display-inline="yes-display-inline">$652,709,000 plus the amount of the
inflation adjustment calculated under subparagraph (A); multiplied by</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HA14114672F6C48479EBC60221D6BEFD9"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HED278BB3E1CC4FBBAC4AB01CE9755499"><enum>(C)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9E22601A0D334E458C17026436F79426"><enum>(3)</enum><text display-inline="yes-display-inline">by striking subsection (c) and inserting
the following:</text>
<quoted-block display-inline="no-display-inline" id="H59528DFD8E624560A730967AC84E5E44" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H838B3C433D304A1F8A16876C7B759532"><enum>(c)</enum><header display-inline="yes-display-inline">Adjustments</header>
<paragraph commented="no" display-inline="no-display-inline" id="H8DBCA00536B648B78B363C9B5A21EE82"><enum>(1)</enum><header display-inline="yes-display-inline">Inflation adjustment</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H8DA11118FF8F445F8F02F1B0A5966D8B"><enum>(A)</enum><text display-inline="yes-display-inline">one;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6958A4B8159C4D46B47AE1FEC0A361A8"><enum>(B)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H665DC0BE60994AACA75B4E0BC9CBCB02"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph">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.</continuation-text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H70A3009E635F4A70BA06D80D155C2B4E"><enum>(2)</enum><header display-inline="yes-display-inline">Workload adjustment</header><text display-inline="yes-display-inline">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:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H258FA3BBA4B5439CA296AF5EF3FCD8E6"><enum>(A)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H571E4444A5854207A84F6D49B54F2363"><enum>(B)</enum><text display-inline="yes-display-inline">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).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4E3EC4F2E08E45E0954C80CEF037260D"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H31701112138F46FFAF5DF69524D29CB3"><enum>(3)</enum><header display-inline="yes-display-inline">Final year adjustment</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4B7DB71486AA4743BA1B08964A458C14"><enum>(4)</enum><header display-inline="yes-display-inline">Annual fee setting</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HAD632A2716D740F5826C9C11EBB63AA8"><enum>(5)</enum><header display-inline="yes-display-inline">Limit</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6169FDE9540D447FA52CB20640C5A5A4"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (g)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HBBCA8F058B5047DDB46C9853903CDE79"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>Fees
authorized</quote> and inserting <quote>Subject to paragraph (2)(C), fees
authorized</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H58186C1B5B7546B3B7CEE2FD189B8B59"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<clause commented="no" display-inline="no-display-inline" id="HE1F3F865B7FC41E6856DCAD04D1CFD9A"><enum>(i)</enum><text display-inline="yes-display-inline">in subparagraph (A)(i), by striking
<quote>shall be retained</quote> and inserting <quote>subject to subparagraph
(C), shall be collected and available</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H5804B976D0A14F9F8BE62A92058A9480"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (A)(ii), by striking
<quote>shall only be collected and available</quote> and inserting <quote>shall
be available</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HB7F0358418A042748EFC3873326FB17F"><enum>(iii)</enum><text display-inline="yes-display-inline">by adding at the end the following new
subparagraph:</text>
<quoted-block display-inline="no-display-inline" id="H14B739B8E0B24771AF6569360E0BBB90" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H6BBD623092DF46DCAF666041E2FC64DC"><enum>(C)</enum><header display-inline="yes-display-inline">Provision for early payments</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB35950B5CF1742D588194A1B2128E567"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (3), by striking <quote>fiscal
years 2008 through 2012</quote> and inserting <quote>fiscal years 2013 through
2017</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE2E171BE3ADF4C2E911C1E787ACCA2D5"><enum>(D)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text>
<clause commented="no" display-inline="no-display-inline" id="HF7A8AF7F31434898B6F17DD9A613FE6D"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal years 2008
through 2010</quote> and inserting <quote>fiscal years 2013 through
2015</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H4F934CA2A36749A482D231749F10C1BF"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal year 2011</quote>
and inserting <quote>fiscal year 2016</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HED90B42BF2C341AAAA405CD0715270BB"><enum>(iii)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal years 2008
through 2011</quote> and inserting <quote>fiscal years 2013 through
2016</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H43B433822BBA48ACB46977C9B0438E4D"><enum>(iv)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal year 2012</quote>
and inserting <quote>fiscal year 2017</quote>.</text>
</clause></subparagraph></paragraph></section><section commented="no" display-inline="no-display-inline" id="HE4E7F67EDD4B44B098EF22DCAF430C0E" section-type="subsequent-section"><enum>104.</enum><header display-inline="yes-display-inline">Reauthorization; reporting
requirements</header><text display-inline="no-display-inline">Section 736B (21
U.S.C. 379h–2) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H130D006761864677AF5D59467D4D381B"><enum>(1)</enum><text display-inline="yes-display-inline">by amending subsection (a) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="HD5AFB542AEAB4FC99430C400DC35349E" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HE55B7A8498B948BAAAE9A228EC774404"><enum>(a)</enum><header display-inline="yes-display-inline">Performance report</header>
<paragraph commented="no" display-inline="no-display-inline" id="H85B16ED46A444FADAAB41DEDF7B0A8FA"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H0F2063D36C2C49C0BBBD063BBE5C41EF"><enum>(A)</enum><text display-inline="yes-display-inline">the progress of the Food and Drug
Administration in achieving the goals identified in the letters described in
section 101(b) of the <short-title>Prescription Drug User
Fee Amendments of 2012</short-title> 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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB82F80FFC00C4427B5CC9DA49B412EDE"><enum>(B)</enum><text display-inline="yes-display-inline">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—</text>
<clause commented="no" display-inline="no-display-inline" id="H767DF244B5234488B32E5C0D1CEE9943"><enum>(i)</enum><text display-inline="yes-display-inline">the number of original standard new drug
applications and biologics license applications filed per fiscal year for each
review division;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HB196427AA19B4C498BF47AEFA0A239B6"><enum>(ii)</enum><text display-inline="yes-display-inline">the number of original priority new drug
applications and biologics license applications filed per fiscal year for each
review division;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HE6258716E91A4677AC880B91E5FBC261"><enum>(iii)</enum><text display-inline="yes-display-inline">the number of standard efficacy supplements
filed per fiscal year for each review division;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H4D28F0AED1C646CFA790C92C84BF40AB"><enum>(iv)</enum><text display-inline="yes-display-inline">the number of priority efficacy supplements
filed per fiscal year for each review division;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HA1587EE9B69341F9BD773DA00AF12505"><enum>(v)</enum><text display-inline="yes-display-inline">the number of applications filed for review
under accelerated approval per fiscal year for each review division;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HBB492D8AC314486899679528A3F171A2"><enum>(vi)</enum><text display-inline="yes-display-inline">the number of applications filed for review
as fast track products per fiscal year for each review division;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HF0A2876FB89E44788D1087F39023DF5D"><enum>(vii)</enum><text display-inline="yes-display-inline">the number of applications filed for
orphan-designated products per fiscal year for each review division; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HB86684AE389D4071B66AB113F2D6ED5D"><enum>(viii)</enum><text display-inline="yes-display-inline">the number of breakthrough designations for
a fiscal year for each review division.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H885E088C6CBD4EE49F33CAA69CE7FB09"><enum>(2)</enum><header display-inline="yes-display-inline">Inclusion</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H576A823FEF874B67AF16A3EF5035DBC0"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b), by striking
<quote>2008</quote> and inserting <quote>2013</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE3C4D3B9EE50403889EAED5F4DC9B457"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (d), by striking
<quote>2012</quote> each place it appears and inserting
<quote>2017</quote>.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="HA6A2AB2A6ABD4E18B64A56712596C91E" section-type="subsequent-section"><enum>105.</enum><header display-inline="yes-display-inline">Sunset dates</header>
<subsection commented="no" display-inline="no-display-inline" id="H8FDB9136840548BE882DC2AF1B1C09E4"><enum>(a)</enum><header display-inline="yes-display-inline">Authorization</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HA5A4269B1DD84B49A08056B6F70F8320"><enum>(b)</enum><header display-inline="yes-display-inline">Reporting requirements</header><text display-inline="yes-display-inline">Section 736B of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h–2) shall cease to be effective January 31,
2018.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HCF4AA04274434E1BB7A81D1C7048DB8A"><enum>(c)</enum><header display-inline="yes-display-inline">Previous sunset provision</header>
<paragraph commented="no" display-inline="no-display-inline" id="H602073F76DBE4AB9907D78017C3CEB7B"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 106 of the Food and Drug
Administration Amendments Act of 2007 (Public Law 110–85) is repealed.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3610D5B27C7F4B3F8E350349FC88B769"><enum>(2)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H6ADD129140FD49A2AFD3A8C54385F599"><enum>(d)</enum><header display-inline="yes-display-inline">Technical clarifications</header>
<paragraph commented="no" display-inline="no-display-inline" id="H04508C0EFBC1419FB4CD544AFDE01746"><enum>(1)</enum><text display-inline="yes-display-inline">Effective September 30, 2007—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H511C82F8D5BF4684AF887379F24B93AC"><enum>(A)</enum><text display-inline="yes-display-inline">section 509 of the Prescription Drug User
Fee Amendments Act of 2002 (Title V of Public Law 107–188) is repealed;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H20F6CF19D8F1437389F136C5F61DAA0D"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H140960CF6591478BB3620E461A50912F"><enum>(2)</enum><text display-inline="yes-display-inline">Effective September 30, 2002—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HDB0F17E36B19463D843E01DF491DFA0E"><enum>(A)</enum><text display-inline="yes-display-inline">section 107 of the Food and Drug
Administration Modernization Act of 1997 (Public Law 105–115) is repealed;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5B99242DA0DF4D2795F60A421DA76E60"><enum>(B)</enum><text display-inline="yes-display-inline">the table of contents in section 1(c) of
such Act is amended by striking the item related to section 107.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2C3F4C6B800A4A15B3AFA306488F9240"><enum>(3)</enum><text display-inline="yes-display-inline">Effective September 30, 1997, section 105
of the Prescription Drug User Fee Act of 1992 (Public Law 102–571) is
repealed.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H0EC61A195F984B3FA40421E7E4B8FE9A" section-type="subsequent-section"><enum>106.</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="no-display-inline">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.</text>
</section><section commented="no" display-inline="no-display-inline" id="H86296CB14A6C41E284C9775D31EE9E3F" section-type="subsequent-section"><enum>107.</enum><header display-inline="yes-display-inline">Savings
clause</header><text display-inline="no-display-inline">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.</text>
</section><enum>II</enum><header display-inline="yes-display-inline">Fees relating to devices</header>
<section commented="no" display-inline="no-display-inline" id="H3C1091C42CCD44EAB602AC93177BC151" section-type="subsequent-section"><enum>201.</enum><header display-inline="yes-display-inline">Short title; findings</header>
<subsection commented="no" display-inline="no-display-inline" id="H9563A8BAFFD34C7AA80773B9721D1BFB"><enum>(a)</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="yes-display-inline">This title may be cited as the
<quote><short-title>Medical Device User Fee Amendments of
2012</short-title></quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H745BD3BBBD134D37B756BC91EB3D0B82"><enum>(b)</enum><header display-inline="yes-display-inline">Findings</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H16CE9FFADAC5416DBD62A6329E78EBD9" section-type="subsequent-section"><enum>202.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">Section 737 (21 U.S.C. 379i) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HED9BF14FDA024A9FAAFE12BAA1AA8AA6"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (9), by striking
<quote>incurred</quote> after <quote>expenses</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9D3D283E0D30433EA4F83C2B18B93581"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (10), by striking
<quote>October 2001</quote> and inserting <quote>October 2011</quote>;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0D163C52AF3D4CE5A285939CEFA6ECD3"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (13), by striking <quote>is
required to register</quote> and all that follows through the end of paragraph
(13) and inserting the following: <quote>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.</quote>.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H6343E275E3D848998FBB550C88C560D8" section-type="subsequent-section"><enum>203.</enum><header display-inline="yes-display-inline">Authority to assess and use device
fees</header>
<subsection commented="no" display-inline="no-display-inline" id="H3887AEF715F449A983E531B881D28913"><enum>(a)</enum><header display-inline="yes-display-inline">Types of fees</header><text display-inline="yes-display-inline">Section 738(a) (21 U.S.C. 379j(a)) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H96EB7725286A40A3AC82C4C2EEA12184"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>fiscal
year 2008</quote> and inserting <quote>fiscal year 2013</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6494A14F44044C98ABB8BF3CED9D5C28"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2)(A)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HB18DBD66A3B549DEB7B823B936002FC4"><enum>(A)</enum><text display-inline="yes-display-inline">in the matter preceding clause (i)—</text>
<clause commented="no" display-inline="no-display-inline" id="HE37C4D86A2E84B769D0581FC3E12E30F"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>subsections (d) and
(e)</quote> and inserting <quote>subsections (d), (e), and (f)</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HDFD52098C05E49E59F477FB40235CACD"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>October 1, 2002</quote>
and inserting <quote>October 1, 2012</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H11C113F616C0444BA61C6B3837A133B1"><enum>(iii)</enum><text display-inline="yes-display-inline">by striking <quote>subsection
(c)(1)</quote> and inserting <quote>subsection (c)</quote>; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9F758A71F43B4487BCAA6355082B324D"><enum>(B)</enum><text display-inline="yes-display-inline">in clause (viii), by striking
<quote>1.84</quote> and inserting <quote>2</quote>; and</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9FFE321FC0494049B5E60E71D016DE30"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (3)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HAB578EE51FE541E6B0112E5F4293A22F"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A), by inserting
<quote>and subsection (f)</quote> after <quote>subparagraph (B)</quote>;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H96E8A10028CC449090CCD1301C67F1AE"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (C), by striking
<quote>initial registration</quote> and all that follows through <quote>section
510.</quote> and inserting</text>
<quoted-block display-inline="yes-display-inline" id="HB8CDB460FD7B4C60A06ADF996606B2FA" style="OLC">
<text>later
of—</text><clause commented="no" display-inline="no-display-inline" id="H2CAA820122314F22AC7DC7697DA4B80B"><enum>(i)</enum><text display-inline="yes-display-inline">the initial or annual registration (as
applicable) of the establishment under section 510; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H7BEBD0DBCF224DBAAEFE430B57D98889"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H0960929C2C6A4770AB92DF0F33CD8776"><enum>(b)</enum><header display-inline="yes-display-inline">Fee amounts</header><text display-inline="yes-display-inline">Section 738(b) (21 U.S.C. 379j(b)) is
amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H40CDC08A8C074070BE4BD3D352F03E68" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H7DCDB0C821BD490FA2482152AA76233C"><enum>(b)</enum><header display-inline="yes-display-inline">Fee amounts</header>
<paragraph commented="no" display-inline="no-display-inline" id="H41A120ADE55342D4846091BD9C8FD9BE"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H94A4898354FD4EBDAA0F0C965B325532"><enum>(2)</enum><header display-inline="yes-display-inline">Base fee amounts specified</header><text display-inline="yes-display-inline">For purposes of paragraph (1), the base fee
amounts specified in this paragraph are as follows:</text>
<table blank-lines-after="0" blank-lines-before="0" line-rules="hor-ver" rule-weights="4.4.4.4.0.0">
<tgroup cols="6" grid-typeface="1.1" thead-tbody-ldg-size="8.8.8" ttitle-size="10"><colspec coldef="txt" colname="col1" min-data-value="60"></colspec><colspec coldef="fig" colname="col2" min-data-value="8"></colspec><colspec coldef="fig" colname="col3" min-data-value="8"></colspec><colspec coldef="fig" colname="col4" min-data-value="8"></colspec><colspec coldef="fig" colname="col5" min-data-value="8"></colspec><colspec coldef="fig" colname="col6" min-data-value="8"></colspec>
<thead>
<row><entry align="center" colname="col1">Fee Type</entry><entry align="center" colname="col2">Fiscal Year 2013</entry><entry align="center" colname="col3">Fiscal Year 2014</entry><entry align="center" colname="col4">Fiscal Year 2015</entry><entry align="center" colname="col5">Fiscal Year 2016</entry><entry align="center" colname="col6">Fiscal Year 2017</entry>
</row>
</thead>
<tbody>
<row><entry colname="col1" stub-definition="txt-ldr" stub-hierarchy="1">Premarket Application</entry><entry colname="col2">$248,000</entry><entry colname="col3">$252,960</entry><entry colname="col4">$258,019</entry><entry colname="col5">$263,180</entry><entry colname="col6">$268,443</entry>
</row>
<row><entry colname="col1" stub-definition="txt-ldr" stub-hierarchy="1">Establishment Registration</entry><entry colname="col2">$2,575</entry><entry colname="col3">$3,200</entry><entry colname="col4">$3,750</entry><entry colname="col5">$3,872</entry><entry colname="col6">$3,872</entry>
</row>
</tbody>
</tgroup>
</table>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H662261CA61DB4D8CAB104CB34D374A0A"><enum>(3)</enum><header display-inline="yes-display-inline">Total revenue amounts
specified</header><text display-inline="yes-display-inline">For purposes of
paragraph (1), the total revenue amounts specified in this paragraph are as
follows:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HA4E894616A8D40B9B0FD457710EE3DA3"><enum>(A)</enum><text display-inline="yes-display-inline">$97,722,301 for fiscal year 2013.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5F237B4DF82B4D889DF4C36E6C9D1B59"><enum>(B)</enum><text display-inline="yes-display-inline">$112,580,497 for fiscal year 2014.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC7D5DA7E8C10475095E90CD0306F1D62"><enum>(C)</enum><text display-inline="yes-display-inline">$125,767,107 for fiscal year 2015.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2F029A5210544D99A4AFF5A3C0998E57"><enum>(D)</enum><text display-inline="yes-display-inline">$129,339,949 for fiscal year 2016.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H15F6649EC7CF4F1B9BDCB1A6A6E7731C"><enum>(E)</enum><text display-inline="yes-display-inline">$130,184,348 for fiscal year
2017.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H48DCFA557D1849EE8373FA19417310E8"><enum>(c)</enum><header display-inline="yes-display-inline">Annual fee setting;
adjustments</header><text display-inline="yes-display-inline">Section 738(c)
(21 U.S.C. 379j(c)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H9F51038DDC9F4631A034107043A6C97D"><enum>(1)</enum><text display-inline="yes-display-inline">in the subsection heading, by inserting
<quote><header-in-text level="subsection" style="OLC">;
Adjustments</header-in-text></quote> after <quote><header-in-text level="subsection" style="OLC">Setting</header-in-text></quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD35819B0C24848CE9BCADEC60A6FF02E"><enum>(2)</enum><text display-inline="yes-display-inline">by striking paragraphs (1) and (2);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HAFDD8EBBB7A9473EA31CF230707B61E0"><enum>(3)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (3) and (4) as
paragraphs (4) and (5), respectively; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H26CD708E7D1A4A729D02A215121374AE"><enum>(4)</enum><text display-inline="yes-display-inline">by inserting before paragraph (4), as so
redesignated, the following:</text>
<quoted-block display-inline="no-display-inline" id="H3C7B52BAD9514170B34EBDE557C74227" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H1336C30D511A4A82813FFA5217476AFD"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H01929781463A4F19827DFA23D23E747C"><enum>(2)</enum><header display-inline="yes-display-inline">Inflation adjustments</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HE7DFF3DF1ABF4047A1D2FBB684D6305B"><enum>(A)</enum><header display-inline="yes-display-inline">Adjustment to total revenue
amounts</header><text display-inline="yes-display-inline">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
<internal-xref idref="HBF555E442821405D8278D394E37FA31F" legis-path="(2)(B)">subparagraph (B)</internal-xref> for such year.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBF555E442821405D8278D394E37FA31F"><enum>(B)</enum><header display-inline="yes-display-inline">Applicable inflation adjustment to total
revenue amounts</header><text display-inline="yes-display-inline">The
applicable inflation adjustment for a fiscal year is—</text>
<clause commented="no" display-inline="no-display-inline" id="H4C9F1853F0C8463398764773B668560C"><enum>(i)</enum><text display-inline="yes-display-inline">for fiscal year 2014, the base inflation
adjustment under
<internal-xref idref="H90C4C73BA6FF4D22AB05F9B46C275A48" legis-path="(2)(C)">subparagraph (C)</internal-xref> for such fiscal year;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H8F8AB7AD789247E2AB9DE0C27BA1314A"><enum>(ii)</enum><text display-inline="yes-display-inline">for fiscal year 2015 and each subsequent
fiscal year, the product of—</text>
<subclause commented="no" display-inline="no-display-inline" id="H85E355B17C284F769975D97A23C5D854"><enum>(I)</enum><text display-inline="yes-display-inline">the base inflation adjustment under
<internal-xref idref="H90C4C73BA6FF4D22AB05F9B46C275A48" legis-path="(2)(C)">subparagraph (C)</internal-xref> for such fiscal year;
and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H22303DBAA7F14CB0B2BB855D73A24273"><enum>(II)</enum><text display-inline="yes-display-inline">the product of the base inflation
adjustment under
<internal-xref idref="H90C4C73BA6FF4D22AB05F9B46C275A48" legis-path="(2)(C)">subparagraph (C)</internal-xref> for each of the fiscal
years preceding such fiscal year, beginning with fiscal year 2014.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H90C4C73BA6FF4D22AB05F9B46C275A48"><enum>(C)</enum><header display-inline="yes-display-inline">Base inflation adjustment to total revenue
amounts</header>
<clause commented="no" display-inline="no-display-inline" id="H183FBCCEAB1F4727B8F6C0621B256893"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subject to further adjustment under clause
(ii), the base inflation adjustment for a fiscal year is the sum of one
plus—</text>
<subclause commented="no" display-inline="no-display-inline" id="H91D39BF6847947D696D46C6F747159C6"><enum>(I)</enum><text display-inline="yes-display-inline">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</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HDF79B2FC1CBB48E5849BA584F4BC99EE"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H2FD3E1D5BF4D4F189314ECEE4C893FB0"><enum>(ii)</enum><header display-inline="yes-display-inline">Limitations</header><text display-inline="yes-display-inline">For purposes of
<internal-xref idref="HBF555E442821405D8278D394E37FA31F" legis-path="(2)(B)">subparagraph (B)</internal-xref>, if the base inflation
adjustment for a fiscal year under clause (i)—</text>
<subclause commented="no" display-inline="no-display-inline" id="HD482690DFE5B41AA92B358CD7F8C6011"><enum>(I)</enum><text display-inline="yes-display-inline">is less than 1, such adjustment shall be
considered to be equal to 1; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H07E1DDE5FBBD4AE59A8A5CA3BCED07F9"><enum>(II)</enum><text display-inline="yes-display-inline">is greater than 1.04, such adjustment shall
be considered to be equal to 1.04.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H83B7E1E0CA8B40DD897D5D3216231A80"><enum>(D)</enum><header display-inline="yes-display-inline">Adjustment to base fee
amounts</header><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDE28C829C5D84614930C2F92F0F9EE10"><enum>(3)</enum><header display-inline="yes-display-inline">Volume-based adjustments to establishment
registration base fees</header><text display-inline="yes-display-inline">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).</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF57517D2E1EA4D499B4B272AA89978B7"><enum>(d)</enum><header display-inline="yes-display-inline">Fee waiver or reduction</header><text display-inline="yes-display-inline">Section 738 (21 U.S.C. 379j) is amended
by—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HD5BA2DCABB554F769318B35489860F56"><enum>(1)</enum><text display-inline="yes-display-inline">redesignating subsections (f) through (k)
as subsections (g) through (l), respectively; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H8BA2EE42AEDE423C854AE801718CE8E2"><enum>(2)</enum><text display-inline="yes-display-inline">by inserting after subsection (e) the
following new subsection:</text>
<quoted-block display-inline="no-display-inline" id="H44D76D95D5F2431B865595863C50E656" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H819FD969680045D2BD2F9811149A3EBE"><enum>(f)</enum><header display-inline="yes-display-inline">Fee waiver or reduction</header>
<paragraph commented="no" display-inline="no-display-inline" id="HD94A441C29E04D57BE2EAFC80F7BA1E8"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3A172157ABA9497282FFBBAAF6FD6FE7"><enum>(2)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF896A8224A7449B29FE7DFA82917774F"><enum>(3)</enum><header display-inline="yes-display-inline">Duration</header><text display-inline="yes-display-inline">The authority provided by this subsection
terminates October 1,
2017.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H7C4A962690534967B960A617EDAD10DD"><enum>(e)</enum><header display-inline="yes-display-inline">Conditions</header><text display-inline="yes-display-inline">Section 738(h)(1)(A) (21 U.S.C.
379j(h)(1)(A)), as redesignated by subsection (d)(1), is amended by striking
<quote>$205,720,000</quote> and inserting <quote>$280,587,000</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H565D90E4B01D4892843D94A36CE62855"><enum>(f)</enum><header display-inline="yes-display-inline">Crediting and availability of
fees</header><text display-inline="yes-display-inline">Section 738(i) (21
U.S.C. 379j(i)), as redesignated by subsection (d)(1), is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H8D8B924995704E2D9CF52E53D8A1CCC6"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>Fees
authorized</quote> and inserting <quote>Subject to paragraph (2)(C), fees
authorized</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9ECE56AF0D28434AADFA6049F6D41306"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H91C2FB446FFC47D5BBDCFAC43DCE8A87"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text>
<clause commented="no" display-inline="no-display-inline" id="H60CC1309E3164C6EA767EA29ABB82A53"><enum>(i)</enum><text display-inline="yes-display-inline">in clause (i), by striking <quote>shall be
retained</quote> and inserting <quote>subject to subparagraph (C), shall be
collected and available</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H7B9081C76B7F48ABBAFD5764C0EC1F8F"><enum>(ii)</enum><text display-inline="yes-display-inline">in clause (ii)—</text>
<subclause commented="no" display-inline="no-display-inline" id="HE9FE59E41C704284AA352CE68647CF9A"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>collected and</quote>
after <quote>shall only be</quote>; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H43CD6A291CD041A19587228D52C19BF1"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal year 2002</quote>
and inserting <quote>fiscal year 2009</quote>; and</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0C2AF711A0F048EFA563BE9B9E342914"><enum>(B)</enum><text display-inline="yes-display-inline">by adding at the end, the following:</text>
<quoted-block display-inline="no-display-inline" id="HBC8F8849C4394A57837C68BB5781E0EF" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H86C7B014FA474EB187E9F9B8C3651BFB"><enum>(C)</enum><header display-inline="yes-display-inline">Provision for early payments</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC5A629A65A1640B3AB47C9D656F62C0A"><enum>(3)</enum><text display-inline="yes-display-inline">by amending paragraph (3) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="H3E7956240D5C46D0A234FB9172F7824F" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H2EEC8811CA764FE292C31C8A5C1910BC"><enum>(3)</enum><header display-inline="yes-display-inline">Authorizations of
appropriations</header><text display-inline="yes-display-inline">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).</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD7F48189F04B4682BC02278BE18F9C58"><enum>(4)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HF1CBB9C686E34162BF5C975504054881"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal years 2008, 2009,
and 2010</quote> and inserting <quote>fiscal years 2013, 2014, and
2015</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB099E13CE202442386BAD4102424A69F"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal year 2011</quote>
and inserting <quote>fiscal year 2016</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2CAA62CB26D9417DAACAD8576E7EB8C5"><enum>(C)</enum><text display-inline="yes-display-inline">by striking <quote>June 30, 2011</quote>
and inserting <quote>June 30, 2016</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBF78883A6C434541A96D571A5F284141"><enum>(D)</enum><text display-inline="yes-display-inline">by striking <quote>the amount of fees
specified in aggregate in</quote> and inserting <quote>the cumulative amount
appropriated pursuant to</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE4FC328EC3EA4DF1B5E40545945174C7"><enum>(E)</enum><text display-inline="yes-display-inline">by striking <quote>aggregate amount
in</quote> before <quote>excess shall be credited</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE57A8A1807574E06BA474D7BC1CF885F"><enum>(F)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal year 2012</quote>
and inserting <quote>fiscal year 2017</quote>.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H068049EC9E694C0898B3C42BCE256CC9"><enum>(g)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">Section 515(c)(4)(A) (21 U.S.C.
360e(c)(4)(A)) is amended by striking <quote>738(g)</quote> and inserting
<quote>738(h)</quote>.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H17D62637ADD44FE691947BABAE5A23F1" section-type="subsequent-section"><enum>204.</enum><header display-inline="yes-display-inline">Reauthorization; reporting
requirements</header>
<subsection commented="no" display-inline="no-display-inline" id="HA81BD082F76D4A068F1ED5AF192FDEC7"><enum>(a)</enum><header display-inline="yes-display-inline">Reauthorization</header><text display-inline="yes-display-inline">Section 738A(b) (21 U.S.C. 379j–1(b)) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H19D79A3D9046441E9298F732771B9016"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking
<quote>2012</quote> and inserting <quote>2017</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD118D088BA5441019D2D0294A1A41BA6"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (5), by striking
<quote>2012</quote> and inserting <quote>2017</quote>.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H03089713AA854F71B7444C847AD3933C"><enum>(b)</enum><header display-inline="yes-display-inline">Performance reports</header><text display-inline="yes-display-inline">Section 738A(a) (21 U.S.C. 379j–1(a)) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H5D85F5256D4C4E4C93EED02CA9C834D2"><enum>(1)</enum><text display-inline="yes-display-inline">by striking paragraph (1) and inserting the
following:</text>
<quoted-block display-inline="no-display-inline" id="HDAAE35FD47DE4CE69BE0B4D7B57C782D" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H427E3A2847C349068BF4C48E8051B5D5"><enum>(1)</enum><header display-inline="yes-display-inline">Performance report</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H559BBD0F1C704F9A97AA8ABC8B2D5B8A"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 <short-title>Medical Device User Fee
Amendments of 2012</short-title> during such fiscal year and the future plans
of the Food and Drug Administration for meeting the goals.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1F007B902C40499998BAEDDEB5B6C594"><enum>(B)</enum><header display-inline="yes-display-inline">Publication</header><text display-inline="yes-display-inline">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).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB693DF98E5D34482A4F6E4B0365F4A2C"><enum>(C)</enum><header display-inline="yes-display-inline">Updates</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDCADE75F857543F9B2432AAC3AA896C2"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2), by striking <quote>2008
through 2012</quote> and inserting <quote>2013 through 2017</quote>.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="HF4CAB9709AE742A08E5D12A1B0A98234" section-type="subsequent-section"><enum>205.</enum><header display-inline="yes-display-inline">Savings
clause</header><text display-inline="no-display-inline">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.</text>
</section><section commented="no" display-inline="no-display-inline" id="HD660E36C2A2E44C1B988DED48319810B" section-type="subsequent-section"><enum>206.</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="no-display-inline">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.</text>
</section><section commented="no" display-inline="no-display-inline" id="H087E0155504747C394DB41F3F1EE7D34" section-type="subsequent-section"><enum>207.</enum><header display-inline="yes-display-inline">Sunset clause</header>
<subsection commented="no" display-inline="no-display-inline" id="HA4A69E2E81634EBBBB1A79290F16F470"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HD2F9CD0DD28C44A69FED75463B61E87F"><enum>(b)</enum><header display-inline="yes-display-inline">Previous sunset provision</header>
<paragraph commented="no" display-inline="no-display-inline" id="H93CD757C765843C791BEAE41D5C511AC"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 217 of the Food and Drug
Administration Amendments Act of 2007 (Title II of Public Law 110–85) is
repealed.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4B543FA1E44B46988EA8C54BCB207EDB"><enum>(2)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H495221E8CC63488EA41BF09D514AF4AA"><enum>(c)</enum><header display-inline="yes-display-inline">Technical clarification</header><text display-inline="yes-display-inline">Effective September 30, 2007—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H39AA7535B3B04557897DF7845C985DBA"><enum>(1)</enum><text display-inline="yes-display-inline">section 107 of the Medical Device User Fee
and Modernization Act of 2002 (Public Law 107–250) is repealed; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE246DDE6AD9C44D1B881D698E6537099"><enum>(2)</enum><text display-inline="yes-display-inline">the table of contents in section 1(b) of
such Act is amended by striking the item related to section 107.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H83E8BC21743E4494AF87B9DBFDF14BC5" section-type="subsequent-section"><enum>208.</enum><header display-inline="yes-display-inline">Streamlined hiring authority to support
activities related to the process for the review of device
applications</header><text display-inline="no-display-inline">Subchapter A of
chapter VII (21 U.S.C. 371 et seq.) is amended by inserting after section 713
the following new section:</text>
<quoted-block display-inline="no-display-inline" id="HF8446A1B58AC49FC8358741651EA707A" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H307EEC09BCE84E4B892E71A65356E2B1" section-type="subsequent-section"><enum>714.</enum><header display-inline="yes-display-inline">Streamlined hiring authority</header>
<subsection commented="no" display-inline="no-display-inline" id="H1523E4696B184F848D926810EFE04C39"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HF0B93D0179AD4D9BA1DF99F2B856EC56"><enum>(b)</enum><header display-inline="yes-display-inline">Activities described</header><text display-inline="yes-display-inline">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)).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HA444A8B04D544FE184AF7D05577175F6"><enum>(c)</enum><header display-inline="yes-display-inline">Objectives specified</header><text display-inline="yes-display-inline">The objectives specified in this subsection
are with respect to the activities under subsection (b), the goals referred to
in section 738A(a)(1).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HFDFDDAB11D894B099E970DB6176808D2"><enum>(d)</enum><header display-inline="yes-display-inline">Internal controls</header><text display-inline="yes-display-inline">The Secretary shall institute appropriate
internal controls for appointments under this section.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HBFAE6889E90A4172B39AD6B8874C8248"><enum>(e)</enum><header display-inline="yes-display-inline">Sunset</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><after-quoted-block>.
</after-quoted-block></quoted-block>
</section><enum>III</enum><header display-inline="yes-display-inline">Fees relating to generic drugs</header>
<section commented="no" display-inline="no-display-inline" id="HE2A66DA348D940DBAE197008D7316F16" section-type="subsequent-section"><enum>301.</enum><header display-inline="yes-display-inline">Short title</header>
<subsection commented="no" display-inline="no-display-inline" id="HE7D734BB6D6D494289722F31267852DB"><enum>(a)</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="yes-display-inline">This title may be cited as the
<quote><short-title>Generic Drug User Fee Amendments of
2012</short-title></quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H59AD885E3F194D668AA7723492D399BA"><enum>(b)</enum><header display-inline="yes-display-inline">Finding</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H2E823976E7E54A3C899BE86531C47830" section-type="subsequent-section"><enum>302.</enum><header display-inline="yes-display-inline">Authority to assess and use human generic
drug fees</header><text display-inline="no-display-inline">Subchapter C of
chapter VII (21 U.S.C. 379f et seq.) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HF9D3AB02F3714E23AE53EE092082B4BD" style="OLC">
<part commented="no" id="HC78FED53B0504378A91F84670353E764" level-type="subsequent"><enum>7</enum><header display-inline="yes-display-inline">FEES RELATING TO GENERIC DRUGS </header>
<section commented="no" display-inline="no-display-inline" id="HF088232CD3C640A8997F8022ECDA6B4D" section-type="subsequent-section"><enum>744A.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">For purposes of this part:</text>
<paragraph commented="no" display-inline="no-display-inline" id="HF4FB11DC79884D88BF1FC813E0CA2824"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>abbreviated new drug
application</term>—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H9770B9F8757B4185995E949F01D477CA"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBBC44E91188E4A72AA2B2C90DC749518"><enum>(B)</enum><text display-inline="yes-display-inline">does not include an application for a
positron emission tomography drug.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF5EDE7A9A09A45A7B55991B18D3151FA"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>active pharmaceutical
ingredient</term> means—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HBFB0FFF8D3304DDAA85114D0CCDD9C80"><enum>(A)</enum><text display-inline="yes-display-inline">a substance, or a mixture when the
substance is unstable or cannot be transported on its own, intended—</text>
<clause commented="no" display-inline="no-display-inline" id="H022F35757B6A4769818FFC1F79C522B5"><enum>(i)</enum><text display-inline="yes-display-inline">to be used as a component of a drug;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HD5F6BEF765814AA39FF2B7CB7C86AE16"><enum>(ii)</enum><text display-inline="yes-display-inline">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</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H478F815E667F40DDA2B758914C50F95A"><enum>(B)</enum><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5E2B767EA98242EB8CCACEBB71DE6590"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>adjustment factor</term>
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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H197C4EA82DB14300A6321B52F5C2A17D"><enum>(4)</enum><text display-inline="yes-display-inline">The term <term>affiliate</term> means a
business entity that has a relationship with a second business entity if,
directly or indirectly—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HE356700CA3294ADAA16D6C691A0BEA85"><enum>(A)</enum><text display-inline="yes-display-inline">one business entity controls, or has the
power to control, the other business entity; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HFA8B55EF22CF44C08B6FB44601BCA134"><enum>(B)</enum><text display-inline="yes-display-inline">a third party controls, or has power to
control, both of the business entities.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7EB2B67EF6264CF48D26F2CC958A5A93"><enum>(5)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H6CD167D57F544B41B24584E4F83A99EA"><enum>(A)</enum><text display-inline="yes-display-inline">The term <term>facility</term>—</text>
<clause commented="no" display-inline="no-display-inline" id="HC0D4648F0DE640CC82757E95821D7E88" indent="up1"><enum>(i)</enum><text display-inline="yes-display-inline">means a business or other entity—</text>
<subclause commented="no" display-inline="no-display-inline" id="H668B1D4A6D514C15A173016524431320"><enum>(I)</enum><text display-inline="yes-display-inline">under one management, either direct or
indirect; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H608283A338074BBA9C87938AE7AAE4CF"><enum>(II)</enum><text display-inline="yes-display-inline">at one geographic location or address
engaged in manufacturing or processing an active pharmaceutical ingredient or a
finished dosage form; and</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="HE2FC56ACD502451CAAAE0378E114818D" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H36491ECA623B4A498247718B4EE299E7" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">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—</text>
<clause commented="no" display-inline="no-display-inline" id="H0A279E50662C4E7DA407E73C453B2788"><enum>(i)</enum><text display-inline="yes-display-inline">closely related to the same business
enterprise;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H4CC9BF482F524AF8A235FBC8DD9A98E1"><enum>(ii)</enum><text display-inline="yes-display-inline">under the supervision of the same local
management; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HCE5AB4EBE47F4CB39896E01BD0FB8C33"><enum>(iii)</enum><text display-inline="yes-display-inline">capable of being inspected by the Food and
Drug Administration during a single inspection.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF7BAB923BA4442CD8FB55F967124B11F" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6D1BF622EF144064A1880714320B2784"><enum>(6)</enum><text display-inline="yes-display-inline">The term <term>finished dosage form</term>
means—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HF9B6FCDD639046738E79263052CD0A29"><enum>(A)</enum><text display-inline="yes-display-inline">a drug product in the form in which it will
be administered to a patient, such as a tablet, capsule, solution, or topical
application;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6CD884101E6E4308839F6FEF427BED13"><enum>(B)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC83C9102F68F40B79F973A243C3B6925"><enum>(C)</enum><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB202508AAFC8481F9B83A35A31A2F66F"><enum>(7)</enum><text display-inline="yes-display-inline">The term <term>generic drug
submission</term> 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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H514BC413CBB345049A4BEF294C8733BC"><enum>(8)</enum><text display-inline="yes-display-inline">The term <term>human generic drug
activities</term> means the following activities of the Secretary associated
with generic drugs and inspection of facilities associated with generic
drugs:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H2A85F546A9294D86B2B09A1E04D3F6B3"><enum>(A)</enum><text display-inline="yes-display-inline">The activities necessary for the review of
generic drug submissions, including review of drug master files referenced in
such submissions.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H460E832A867143D395972AB204717C1A"><enum>(B)</enum><text display-inline="yes-display-inline">The issuance of—</text>
<clause commented="no" display-inline="no-display-inline" id="H2DD661C698AD493B92C4E43972EC74B7"><enum>(i)</enum><text display-inline="yes-display-inline">approval letters which approve abbreviated
new drug applications or supplements to such applications; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HD716725E9E384119AE27C8A98F0AB592"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF756002D110F4B70B1B4D3C9DBB6612A"><enum>(C)</enum><text display-inline="yes-display-inline">The issuance of letters related to Type II
active pharmaceutical drug master files which—</text>
<clause commented="no" display-inline="no-display-inline" id="H08F36184466C4503A9FC68AB9B828746"><enum>(i)</enum><text display-inline="yes-display-inline">set forth in detail the specific
deficiencies in such submissions, and where appropriate, the actions necessary
to resolve those deficiencies; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H8A2755F2713149C38792675BA25BB3EA"><enum>(ii)</enum><text display-inline="yes-display-inline">document that no deficiencies need to be
addressed.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H79F3DEC31EB040458CE41F95112026EB"><enum>(D)</enum><text display-inline="yes-display-inline">Inspections related to generic
drugs.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9D50859C35384E5FABD93E6A33FFE652"><enum>(E)</enum><text display-inline="yes-display-inline">Monitoring of research conducted in
connection with the review of generic drug submissions and drug master
files.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H847AA5A5898246E08CF439D19436E53E"><enum>(F)</enum><text display-inline="yes-display-inline">Postmarket safety activities with respect
to drugs approved under abbreviated new drug applications or supplements,
including the following activities:</text>
<clause commented="no" display-inline="no-display-inline" id="HAA49015A0B204DEB972DFAF6BAE0FFF8"><enum>(i)</enum><text display-inline="yes-display-inline">Collecting, developing, and reviewing
safety information on approved drugs, including adverse event reports.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HCF54055E77DA43E4B9F42555174B1384"><enum>(ii)</enum><text display-inline="yes-display-inline">Developing and using improved adverse-event
data-collection systems, including information technology systems.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H779AFDC0185F4FF5997F082C6C0EE92F"><enum>(iii)</enum><text display-inline="yes-display-inline">Developing and using improved analytical
tools to assess potential safety problems, including access to external data
bases.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H7D74A8BAB0294FE3911C861DCDCDE8E6"><enum>(iv)</enum><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H1F5C66EF486E46B4B8A30F8EE0F61676"><enum>(v)</enum><text display-inline="yes-display-inline">Carrying out section 505(k)(5) (relating to
adverse-event reports and postmarket safety activities).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H473459E223F94697A3D8FCE6A315C9B6"><enum>(G)</enum><text display-inline="yes-display-inline">Regulatory science activities related to
generic drugs.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7677EAEBC7934F9F84376192668CACA8"><enum>(9)</enum><text display-inline="yes-display-inline">The term <term>positron emission tomography
drug</term> has the meaning given to the term <term>compounded positron
emission tomography drug</term> in section 201(ii), except that paragraph
(1)(B) of such section shall not apply.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H55E1463CAA714050BA8E37E24143B37A"><enum>(10)</enum><text display-inline="yes-display-inline">The term <term>prior approval
supplement</term> 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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBC5249A56A1444C1B99234E1332EEF96"><enum>(11)</enum><text display-inline="yes-display-inline">The term <term>resources allocated for
human generic drug activities</term> means the expenses for—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H213A9C9D1E3149DA8DBB526DE061F21F"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7F4E367778BA4C17A1771BD9E8332F61"><enum>(B)</enum><text display-inline="yes-display-inline">management of information, and the
acquisition, maintenance, and repair of computer resources;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H475FB790D69A4FC4A06C7F72FAB2FC67"><enum>(C)</enum><text display-inline="yes-display-inline">leasing, maintenance, renovation, and
repair of facilities and acquisition, maintenance, and repair of fixtures,
furniture, scientific equipment, and other necessary materials and supplies;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD8B5AA916B6646EF97A590C8153AFD37"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H631462F2F1D84367B5FCEBD414A51ECB"><enum>(12)</enum><text display-inline="yes-display-inline">The term <term>Type II active
pharmaceutical ingredient drug master file</term> 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.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H63FB681C72694A91AF0CDBFB6DBD3E93" section-type="subsequent-section"><enum>744B.</enum><header display-inline="yes-display-inline">Authority to assess and use human generic
drug fees</header>
<subsection commented="no" display-inline="no-display-inline" id="H008F88F280B54C479590CBE6553093C8"><enum>(a)</enum><header display-inline="yes-display-inline">Types of fees</header><text display-inline="yes-display-inline">Beginning in fiscal year 2013, the
Secretary shall assess and collect fees in accordance with this section as
follows:</text>
<paragraph commented="no" display-inline="no-display-inline" id="H0644C9B1A10148F397780B22AC6720A4"><enum>(1)</enum><header display-inline="yes-display-inline">One-Time Backlog Fee for Abbreviated New
Drug Applications Pending on October 1, 2012</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HC21B60B2F6E34DFFB3F1431679BFBD78"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6283937C412946FD9029AFE57CF367EF"><enum>(B)</enum><header display-inline="yes-display-inline">Method of fee amount
calculation</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF0908578F0DD4EFB9A1EFFB1EA846C7E"><enum>(C)</enum><header display-inline="yes-display-inline">Notice</header><text display-inline="yes-display-inline">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).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4EF2CE3CD0BB40C491334C50A7A53494"><enum>(D)</enum><header display-inline="yes-display-inline">Fee due date</header><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB4346D64E43A43D19C93EF42ACB03786"><enum>(2)</enum><header display-inline="yes-display-inline">Drug Master File Fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HE92C554B56E64EC4BE861529982B0D47"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H102041AEA1C245A3A88392889E2882EB"><enum>(B)</enum><header display-inline="yes-display-inline">One-time payment</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0EE8CFE09DFB48208ECE25579C9E2B84"><enum>(C)</enum><header display-inline="yes-display-inline">Notice</header>
<clause commented="no" display-inline="no-display-inline" id="H88ACEA8B1AF8482CAC3E568CCD08E982"><enum>(i)</enum><header display-inline="yes-display-inline">Fiscal year 2013</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HE576A4C9CEB148BEA830FCF151B89275"><enum>(ii)</enum><header display-inline="yes-display-inline">Fiscal year 2014 through 2017</header><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC896050CA16C41A6B89502AFAF26EE56"><enum>(D)</enum><header display-inline="yes-display-inline">Availability for reference</header>
<clause commented="no" display-inline="no-display-inline" id="HB77D343CB2E2432083A58B9B5B8FF778"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H57F054DDC7E542EE8BCAC9521375536A"><enum>(ii)</enum><header display-inline="yes-display-inline">Conditions</header><text display-inline="yes-display-inline">A drug master file shall be deemed
available for reference by the Secretary if—</text>
<subclause commented="no" display-inline="no-display-inline" id="H6AB84764F65D485EA1D498C961D27685"><enum>(I)</enum><text display-inline="yes-display-inline">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</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H4214EF2206AB4B2A832B065D6B4F30C8"><enum>(II)</enum><text display-inline="yes-display-inline">the drug master file has not failed an
initial completeness assessment by the Secretary, in accordance with criteria
to be published by the Secretary.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H1BC962EBC0FB47B3840A5E86A4FADEAC"><enum>(iii)</enum><header display-inline="yes-display-inline">List</header><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H15481B8985074C02B7103A9B4D756873"><enum>(E)</enum><header display-inline="yes-display-inline">Fee Due Date</header>
<clause commented="no" display-inline="no-display-inline" id="H12BD40043A5A49C799D57710F542E714"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H8C2F00C0F56740A6B4D078E0613D2374"><enum>(ii)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">No fee shall be due under subparagraph (A)
for a fiscal year until the later of—</text>
<subclause commented="no" display-inline="no-display-inline" id="HECFCB1918A8A46A182FFAA6762ECC0E1"><enum>(I)</enum><text display-inline="yes-display-inline">30 calendar days after publication of the
notice provided for in clause (i) or (ii) of subparagraph (C), as applicable;
or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HCB7D25A74DF444C0AE8A4BE606CBA0EF"><enum>(II)</enum><text display-inline="yes-display-inline">30 calendar days after the date of
enactment of an appropriations Act providing for the collection and obligation
of fees under this section.</text>
</subclause></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4944EF734C4D44F788A917D4D132443A"><enum>(3)</enum><header display-inline="yes-display-inline">Abbreviated New Drug Application and Prior
Approval Supplement Filing Fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H3A9D708565AB4F269D4068042B677CC6"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HCBAC683D97654EECBB2BB1D682304EFC"><enum>(B)</enum><header display-inline="yes-display-inline">Notice</header>
<clause commented="no" display-inline="no-display-inline" id="H7BF461BB6F2340CA82A0AEFEEAB5187C"><enum>(i)</enum><header display-inline="yes-display-inline">Fiscal year 2013</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H5F0D8FF4AB5844CAB283545532B96C0F"><enum>(ii)</enum><header display-inline="yes-display-inline">Fiscal years 2014 through
2017</header><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0271385994BE44B19C1BC2F8C48AA45C"><enum>(C)</enum><header display-inline="yes-display-inline">Fee Due Date</header>
<clause commented="no" display-inline="no-display-inline" id="HA573EE60524E4237811CEDD9CE200EA7"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H502BBD8E1CDF4807975A08CC6ED37C96"><enum>(ii)</enum><header display-inline="yes-display-inline">Special rule for 2013</header><text display-inline="yes-display-inline">For fiscal year 2013, such fees shall be
due on the later of—</text>
<subclause commented="no" display-inline="no-display-inline" id="H8B52A5E34B114145B59F10B73C6C556B"><enum>(I)</enum><text display-inline="yes-display-inline">the date on which the fee is due under
clause (i);</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HE07906B62D35483EA4CC7C2DB9615A75"><enum>(II)</enum><text display-inline="yes-display-inline">30 calendar days after publication of the
notice referred to in subparagraph (B)(i); or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H12F7D054E6A244488AE9C86F88935324"><enum>(III)</enum><text display-inline="yes-display-inline">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.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE9FCA5A9BFD94340B7AB22589CBE21E7"><enum>(D)</enum><header display-inline="yes-display-inline">Refund of fee if abbreviated new drug
application is not considered to have been received</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD7418C77AB3B42A3BEF6E0A86C824AD3"><enum>(E)</enum><header display-inline="yes-display-inline">Fee for an application the secretary
considers not to have been received, or that has been withdrawn</header><text display-inline="yes-display-inline">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).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H62473C92EB304CF896BF03DEBD745106"><enum>(F)</enum><header display-inline="yes-display-inline">Additional fee for active pharmaceutical
ingredient information not included by reference to Type II active
pharmaceutical ingredient drug master file</header><text display-inline="yes-display-inline">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—</text>
<clause commented="no" display-inline="no-display-inline" id="H03C98243E6F34C51A07EFBA0BAB8DC37"><enum>(i)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HEDE141A987ED4C4084A5EA8F77F19F89"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H229A0B3F1E5B47CF99A3934E57984B6F"><enum>(4)</enum><header display-inline="yes-display-inline">Generic Drug Facility Fee and Active
Pharmaceutical Ingredient Facility Fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H2F50BF3CB22B4775B22A6921396C36BB"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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:</text>
<clause commented="no" display-inline="no-display-inline" id="HA230D467C4AC43108A6F16F3607E6773"><enum>(i)</enum><header display-inline="yes-display-inline">Generic drug facility</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HB21ADD64429948A1B697AB6802C19C51"><enum>(ii)</enum><header display-inline="yes-display-inline">Active pharmaceutical ingredient
facility</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HF210B10D306C49BFA69D10D4B50D2162"><enum>(iii)</enum><header display-inline="yes-display-inline">Facilities producing both active
pharmaceutical ingredients and finished dosage forms</header><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9B61F79C1CC440A2AE21DC6F96231DC0"><enum>(B)</enum><header display-inline="yes-display-inline">Amount</header><text display-inline="yes-display-inline">The amount of fees established under
subparagraph (A) shall be established under subsection (d).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6E78B950234945DAA65AB0204AF56F69"><enum>(C)</enum><header display-inline="yes-display-inline">Notice</header>
<clause commented="no" display-inline="no-display-inline" id="H605BDB64652B43E1A15A4D985E526439"><enum>(i)</enum><header display-inline="yes-display-inline">Fiscal year 2013</header><text display-inline="yes-display-inline">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).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H37A9A8BBB99E4A239F04B20BCA6E2761"><enum>(ii)</enum><header display-inline="yes-display-inline">Fiscal years 2014 through
2017</header><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAF089A0C1B534A6F8B5ECF8B57647075"><enum>(D)</enum><header display-inline="yes-display-inline">Fee Due Date</header>
<clause commented="no" display-inline="no-display-inline" id="H61741EFBD1294D549BB6ACE6260BD276"><enum>(i)</enum><header display-inline="yes-display-inline">Fiscal year 2013</header><text display-inline="yes-display-inline">For fiscal year 2013, the fees under
subparagraph (A) shall be due on the later of—</text>
<subclause commented="no" display-inline="no-display-inline" id="H171ED7C018394371A9015BC49F080E09"><enum>(I)</enum><text display-inline="yes-display-inline">not later than 45 days after the
publication of the notice under subparagraph (B); or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HDA121175106945F8BB91A73B0825D62B"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H6499971891334D0D9681C213408452E8"><enum>(ii)</enum><header display-inline="yes-display-inline">Fiscal years 2014 through
2017</header><text display-inline="yes-display-inline">For each of fiscal years
2014 through 2017, the fees under subparagraph (A) for such fiscal year shall
be due on the later of—</text>
<subclause commented="no" display-inline="no-display-inline" id="H74A3A956269349FEA40CE6F0CEB19DDC"><enum>(I)</enum><text display-inline="yes-display-inline">the first business day on or after October
1 of each such year; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H5422E21DB068432DA1508FF0D9AEC2A3"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text>
</subclause></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H205670484AF3442EB9973B3A68F8AE69"><enum>(5)</enum><header display-inline="yes-display-inline">Date of submission</header><text display-inline="yes-display-inline">For purposes of this Act, a generic drug
submission or Type II pharmaceutical master file is deemed to be
<quote>submitted</quote> to the Food and Drug Administration—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H6F6D465A58CD45B9BF1A953D0D78D7C7"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HCC615A8EF9394735BF6B2BBDADB9D669"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HD0A5501A2ED34152A3B778DB0038D4C8"><enum>(b)</enum><header display-inline="yes-display-inline">Fee revenue amounts</header>
<paragraph commented="no" display-inline="no-display-inline" id="H7EA89639B38C4AF898E052431BC870FD"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H5B5B7B0E84BF4DE489B2249D9916F836"><enum>(A)</enum><header display-inline="yes-display-inline">Fiscal year 2013</header><text display-inline="yes-display-inline">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—</text>
<clause commented="no" display-inline="no-display-inline" id="H8ECC4AD9A5A8469BAB154367D0926CBC"><enum>(i)</enum><text display-inline="yes-display-inline">$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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H7C8471F41D3C4D78BCD1CE2F8D43BB57"><enum>(ii)</enum><text display-inline="yes-display-inline">$249,000,000 shall be generated by the fees
under paragraphs (2) through (4) of subsection (a).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H21BAC48B1AC54AA4A5A994288B022B63"><enum>(B)</enum><header display-inline="yes-display-inline">Fiscal years 2014 through
2017</header><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H56B402E4316B4BD6923E18BD25E3DEC5"><enum>(2)</enum><header display-inline="yes-display-inline">Types of fees</header><text display-inline="yes-display-inline">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:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H91EFB849DBFA477C8D7E47F57D16CBBD"><enum>(A)</enum><text display-inline="yes-display-inline">Six percent shall be derived from fees
under subsection (a)(2) (relating to drug master files).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF36A7795BE6F4C80A40CB23223EB5DA4"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC61373E5174F45E8AE6DE802661041A9"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6CC75CF96CB749B7AB072CDE8FE14543"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H7DEAE70B0AB6485E830BE416ECF12B25"><enum>(c)</enum><header display-inline="yes-display-inline">Adjustments</header>
<paragraph commented="no" display-inline="no-display-inline" id="HADA6B5E6D62D4F4983FEB3E72FF47A53"><enum>(1)</enum><header display-inline="yes-display-inline">Inflation adjustment</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H265FD6FE180149ADAC77746D81B167DF"><enum>(A)</enum><text display-inline="yes-display-inline">one;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6F55B276F5E846FF8DB7F45A37A2C6CD"><enum>(B)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9B4A16D6F9D7462EB8EA41C7B9B4FC79"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph">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.</continuation-text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBF0B0A1A3A5F4D6E951E0CAA1A6357E0"><enum>(2)</enum><header display-inline="yes-display-inline">Final year adjustment</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H35D5FFBCE61E4C89B97203B641DD1009"><enum>(d)</enum><header display-inline="yes-display-inline">Annual fee setting</header>
<paragraph commented="no" display-inline="no-display-inline" id="H53DD62A80AE440848FADACF1BBB330C8"><enum>(1)</enum><header display-inline="yes-display-inline">Fiscal year 2013</header><text display-inline="yes-display-inline">For fiscal year 2013—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H9DBC87829FB34608B590A2B0F0CB4069"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0B1FADDDA80A4245A7F1B883BCE5AE99"><enum>(B)</enum><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC3C331318E6E434F94723ECD947208FC"><enum>(2)</enum><header display-inline="yes-display-inline">Fiscal years 2014 through
2017</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9469EF1DEA3446078FB1F205771E846F"><enum>(3)</enum><header display-inline="yes-display-inline">Fee for active pharmaceutical ingredient
information not included by reference to Type II active pharmaceutical
ingredient drug master file</header><text display-inline="yes-display-inline">In establishing the fees under paragraphs
(1) and (2), the amount of the fee under subsection (a)(3)(F) shall be
determined by multiplying—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H097B453A57C34FF3B825631EFACF1017"><enum>(A)</enum><text display-inline="yes-display-inline">the sum of—</text>
<clause commented="no" display-inline="no-display-inline" id="H5367ECF3852E45AC8BFB8A3AFA71EA50"><enum>(i)</enum><text display-inline="yes-display-inline">the total number of such active
pharmaceutical ingredients in such submission; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H75EFB75CCC2C431ABAE1C0F481E2EAEE"><enum>(ii)</enum><text display-inline="yes-display-inline">for each such ingredient that is
manufactured at more than one such facility, the total number of such
additional facilities; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H962F7BBD6D874342819ECB1B175FFACD"><enum>(B)</enum><text display-inline="yes-display-inline">the amount equal to the drug master file
fee established in subsection (a)(2) for such submission.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H9CA6636F35344CE5801013D6F5F4778B"><enum>(e)</enum><header display-inline="yes-display-inline">Limit</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HCD427C0BAE5C499E84A802101DF74DE6"><enum>(f)</enum><header display-inline="yes-display-inline">Identification of facilities</header>
<paragraph commented="no" display-inline="no-display-inline" id="H2A343B082FB14856A746313F6B5A0512"><enum>(1)</enum><header display-inline="yes-display-inline">Publication of notice; deadline for
compliance</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H320C98A2E7F448DCB3F2996A4B4CC072"><enum>(2)</enum><header display-inline="yes-display-inline">Required submission of facility
identification</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H8BD601B743344B9D908032E5CF748E26"><enum>(A)</enum><text display-inline="yes-display-inline">for fiscal year 2013, be submitted not
later than 60 days after the publication of the notice under paragraph (1);
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H23546438A7024CB594F492313C304EC2"><enum>(B)</enum><text display-inline="yes-display-inline">for each subsequent fiscal year, be
submitted, updated, or reconfirmed on or before June 1 of the previous
year.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD253F1D1F2C64C9481188F0A1C11EA98"><enum>(3)</enum><header display-inline="yes-display-inline">Contents of notice</header><text display-inline="yes-display-inline">At a minimum, the submission required by
paragraph (2) shall include for each such facility—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HCBF252B282464A6EA5ABA48791290FE6"><enum>(A)</enum><text display-inline="yes-display-inline">identification of a facility identified or
intended to be identified in an approved or pending generic drug
submission;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H056FC9ED722240A1865DDAE566F5495F"><enum>(B)</enum><text display-inline="yes-display-inline">whether the facility manufactures active
pharmaceutical ingredients or finished dosage forms, or both;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB65AB79F95C34A4C81834DCA982D3809"><enum>(C)</enum><text display-inline="yes-display-inline">whether or not the facility is located
within the United States and its territories and possessions;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HABED3BE2CAFF452AA22A76DEF03C39B2"><enum>(D)</enum><text display-inline="yes-display-inline">whether the facility manufactures positron
emission tomography drugs solely, or in addition to other drugs; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H73A066C406654099B7074D41E5049F61"><enum>(E)</enum><text display-inline="yes-display-inline">whether the facility manufactures drugs
that are not generic drugs.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD01237CAC72243678043496D519D5156"><enum>(4)</enum><header display-inline="yes-display-inline">Certain sites and organizations</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HDE25E4645E334F3EBAD5ADCEAF777616"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE83622238CD64CB890F56DA2F9A36CB6"><enum>(B)</enum><header display-inline="yes-display-inline">Sites and organizations</header><text display-inline="yes-display-inline">A site or organization is described in this
subparagraph if it is identified in a generic drug submission and is—</text>
<clause commented="no" display-inline="no-display-inline" id="H2CBED3E028E74FA9BC8DED44DC5F5DBD"><enum>(i)</enum><text display-inline="yes-display-inline">a site in which a bioanalytical study is
conducted;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HA2E407F6C29F46139BFD9C32DF21D444"><enum>(ii)</enum><text display-inline="yes-display-inline">a clinical research organization;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HCB6EFA86C21A4F90844716F3521BF3FC"><enum>(iii)</enum><text display-inline="yes-display-inline">a contract analytical testing site;
or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HCB72C89978D94180B6C6713016E93E22"><enum>(iv)</enum><text display-inline="yes-display-inline">a contract repackager site.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H95B7530CE3124973AE71DE00C6D17030"><enum>(C)</enum><header display-inline="yes-display-inline">Notice</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC776C41609104F75A3B45233CA6711CA"><enum>(D)</enum><header display-inline="yes-display-inline">Inspection authority</header><text display-inline="yes-display-inline">The Secretary’s inspection authority under
section 704(a)(1) shall extend to all such sites and organizations.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H0C93E50CBA694480AF79781E0C89F487"><enum>(g)</enum><header display-inline="yes-display-inline">Effect of failure To pay fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="H9DED244E32D84CEEB437E244EE940ABD"><enum>(1)</enum><header display-inline="yes-display-inline">Generic drug backlog fee</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2B92B53653A842138C90C93365DF54D2"><enum>(2)</enum><header display-inline="yes-display-inline">Drug master file fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H3A743376243A4900A4C658B2990C1C63"><enum>(A)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1D1266ECF3334B048852C26C0A7F567B"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="HD34194AE8E1F4AF8B0327272216861E0"><enum>(i)</enum><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H2E37E3B1D1B7495AB101BC45F3C64A15" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">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).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H258E556B933B4FF89B29C7F50DC89742"><enum>(C)</enum><clause commented="no" display-inline="yes-display-inline" id="HA95289A72C8B4432A5EE0ED2F4EC975D"><enum>(i)</enum><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H5875026E01F947FCB0D09A901A0708CA" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">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).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H26917652259746E59D873C33DDB41E72"><enum>(3)</enum><header display-inline="yes-display-inline">Abbreviated new drug application fee and
prior approval supplement fee</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC021CB3E2E9F4F54A0BA63879B3A6BB9"><enum>(4)</enum><header display-inline="yes-display-inline">Generic drug facility fee and active
pharmaceutical ingredient facility fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H8AE34BBDEC4F4B5B8226A5CB91C6C5B1"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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:</text>
<clause commented="no" display-inline="no-display-inline" id="H99F50FEF24ED4474ABFB8982D49C3428"><enum>(i)</enum><text display-inline="yes-display-inline">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).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H0CFE4FE886A84857B659E07BC01EFD0B"><enum>(ii)</enum><text display-inline="yes-display-inline">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).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HC418069422124B959202BD9A9C052BAE"><enum>(iii)</enum><text display-inline="yes-display-inline">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).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H32C58836E64C4954BCD65806A47AD891"><enum>(B)</enum><header display-inline="yes-display-inline">Application of penalties</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA213F17A1C9C4523876FD48B918A21AD"><enum>(C)</enum><header display-inline="yes-display-inline">Nonreceival for nonpayment</header>
<clause commented="no" display-inline="no-display-inline" id="H2FF8670E4DFD45D08954BEDA578A4DA7"><enum>(i)</enum><header display-inline="yes-display-inline">Notice</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H2553164C3E23492A976FD69AB4D3ED74"><enum>(ii)</enum><header display-inline="yes-display-inline">Nonreceival</header><text display-inline="yes-display-inline">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).</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF9CB245473914DBC8CB17DA778BD72B3"><enum>(h)</enum><header display-inline="yes-display-inline">Limitations</header>
<paragraph commented="no" display-inline="no-display-inline" id="HC367F97C5B094A90A67F4C8890C7A36B"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFA6FC9629AE844B18C6BA4408045CEE0"><enum>(2)</enum><header display-inline="yes-display-inline">Authority</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF06873EAA590404A8A30866484D2B3DC"><enum>(i)</enum><header display-inline="yes-display-inline">Crediting and availability of fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="HF49F0B5ECB87448299D4674B5DD33F9A"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H331A7FC4D8124723A0BC30642BDDFDF8"><enum>(2)</enum><header display-inline="yes-display-inline">Collections and appropriation acts</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H478F69AD85A3495BB82AB927FFFE449D"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The fees authorized by this section—</text>
<clause commented="no" display-inline="no-display-inline" id="H6A7BECE1DA5746F6840EC9A680C241AC"><enum>(i)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H6ACD455D91CA4158BCBE7E77C8D82CFD"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H16C57C14D29C4DEB975C900FC1919E74"><enum>(B)</enum><header display-inline="yes-display-inline">Compliance</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H15EEBE0885454A9A8DD4361603D6D026"><enum>(C)</enum><header display-inline="yes-display-inline">Fee collection during first program
year</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5A0FC970A43143E49B4631D4DC2ACA3C"><enum>(D)</enum><header display-inline="yes-display-inline">Provision for early payments in subsequent
years</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1EA0B870701B4E15998F3D92E88CD137"><enum>(3)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HD61990B369744A2A9B57B09BDC8D7EC0"><enum>(j)</enum><header display-inline="yes-display-inline">Collection of unpaid fees</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H284A992E205E4852BC50334FA69F2639"><enum>(k)</enum><header display-inline="yes-display-inline">Construction</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H81F5C29FBA9D492CA6406BC0A0FAF78B"><enum>(l)</enum><header display-inline="yes-display-inline">Positron emission tomography drugs</header>
<paragraph commented="no" display-inline="no-display-inline" id="HD1CDF76D1C734939BE6F68C3C55B085C"><enum>(1)</enum><header display-inline="yes-display-inline">Exemption from fees</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE272C28F4966412BABAAE9E6672D6A8E"><enum>(2)</enum><header display-inline="yes-display-inline">Identification requirement</header><text display-inline="yes-display-inline">Facilities that produce positron emission
tomography drugs or active pharmaceutical ingredients of such drugs are
required to be identified pursuant to subsection (f).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HDC504C248A5B40B19DC095C663F38A2B"><enum>(m)</enum><header display-inline="yes-display-inline">Disputes concerning fees</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HB380B3179CCF4AADABF89D528A8AFFBB"><enum>(n)</enum><header display-inline="yes-display-inline">Substantially complete
applications</header><text display-inline="yes-display-inline">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 <quote>substantially complete</quote> 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.</text>
</subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H9846BC17437D4C1A955BAC113086E7A3" section-type="subsequent-section"><enum>303.</enum><header display-inline="yes-display-inline">Reauthorization; reporting
requirements</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="HACA125E9FA564630BB741AA0155DCB85" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H6C3CA61AB47D4669AE0980C764DF85B5" section-type="subsequent-section"><enum>744C.</enum><header display-inline="yes-display-inline">Reauthorization; reporting
requirements</header>
<subsection commented="no" display-inline="no-display-inline" id="HD0A5550CEDE54D53953D39CE0BDB9776"><enum>(a)</enum><header display-inline="yes-display-inline">Performance report</header><text display-inline="yes-display-inline">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
<short-title>Generic Drug User Fee Amendments of
2012</short-title> during such fiscal year and the future plans of the Food and
Drug Administration for meeting the goals.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HAC768D9417FC405DBF23F8DF99324539"><enum>(b)</enum><header display-inline="yes-display-inline">Fiscal report</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HC08522A3973D4DFD8C54EC7110BEA0F6"><enum>(c)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HE1792A185B624F2FA0DC7FB8A5931AC7"><enum>(d)</enum><header display-inline="yes-display-inline">Reauthorization</header>
<paragraph commented="no" display-inline="no-display-inline" id="H7E4DCF19BBBC49C887976828F15FFF94"><enum>(1)</enum><header display-inline="yes-display-inline">Consultation</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H3E43037DF7604F0A8240DD1BD5438496"><enum>(A)</enum><text display-inline="yes-display-inline">the Committee on Energy and Commerce of the
House of Representatives;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HCFCD72BCA17B446DAD10968ABA397EDE"><enum>(B)</enum><text display-inline="yes-display-inline">the Committee on Health, Education, Labor,
and Pensions of the Senate;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDFC93094C6124DE9929FDD5EA7B70C89"><enum>(C)</enum><text display-inline="yes-display-inline">scientific and academic experts;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3CFBC4D7DF35443EA8C60F5DA95933AB"><enum>(D)</enum><text display-inline="yes-display-inline">health care professionals;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD945271D6ECC4A98A255C4EE4BC2D3F2"><enum>(E)</enum><text display-inline="yes-display-inline">representatives of patient and consumer
advocacy groups; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5EAB759E5FD140A48C6DFDD789DBEA4E"><enum>(F)</enum><text display-inline="yes-display-inline">the generic drug industry.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H766E601B11384954B6D565FBBEF54773"><enum>(2)</enum><header display-inline="yes-display-inline">Prior public input</header><text display-inline="yes-display-inline">Prior to beginning negotiations with the
generic drug industry on the reauthorization of this part, the Secretary
shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HC66F4802550E410A9A72D00585CE489C"><enum>(A)</enum><text display-inline="yes-display-inline">publish a notice in the Federal Register
requesting public input on the reauthorization;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA5180A23F1464B04AB2301DEB52633C6"><enum>(B)</enum><text display-inline="yes-display-inline">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);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5CA66521B4FF4E0FA42BC4DA7008F728"><enum>(C)</enum><text display-inline="yes-display-inline">provide a period of 30 days after the
public meeting to obtain written comments from the public suggesting changes to
this part; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H03F114E68D7946F39F26BCE1997262F1"><enum>(D)</enum><text display-inline="yes-display-inline">publish the comments on the Food and Drug
Administration’s Internet Web site.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H589CDC2ED0E24D56A72B7F25BB7F6B7C"><enum>(3)</enum><header display-inline="yes-display-inline">Periodic consultation</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4B84D6FC37C94188B7D140B51A8580BD"><enum>(4)</enum><header display-inline="yes-display-inline">Public review of
recommendations</header><text display-inline="yes-display-inline">After
negotiations with the generic drug industry, the Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H163C9297D2D145D8A18AB8DE1C3B6725"><enum>(A)</enum><text display-inline="yes-display-inline">present the recommendations developed under
paragraph (1) to the congressional committees specified in such
paragraph;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB3F266068B904415B242042EE5745655"><enum>(B)</enum><text display-inline="yes-display-inline">publish such recommendations in the Federal
Register;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H36F0E84B2EF64A77B6653EAE2F34C84D"><enum>(C)</enum><text display-inline="yes-display-inline">provide for a period of 30 days for the
public to provide written comments on such recommendations;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB3604D7D4AFF4808BA9FEBD05AC77423"><enum>(D)</enum><text display-inline="yes-display-inline">hold a meeting at which the public may
present its views on such recommendations; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HCF8B4513C639499CA82E6F2D9F0941CF"><enum>(E)</enum><text display-inline="yes-display-inline">after consideration of such public views
and comments, revise such recommendations as necessary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H233ACF29F39C44AA926EA8933862B641"><enum>(5)</enum><header display-inline="yes-display-inline">Transmittal of
recommendations</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H144152A59B9847E6BC96382D24C2C8FF"><enum>(6)</enum><header display-inline="yes-display-inline">Minutes of negotiation meetings</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H01774757675641449FF3DC36B1AF7A8E"><enum>(A)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H077456BE83D048758D18F34E3F8BB51B"><enum>(B)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="HE4061CE44085415294C812E9A9C3C821" section-type="subsequent-section"><enum>304.</enum><header display-inline="yes-display-inline">Sunset dates</header>
<subsection commented="no" display-inline="no-display-inline" id="H1F0E34002A1E44E5AB44A77EA283D748"><enum>(a)</enum><header display-inline="yes-display-inline">Authorization</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HE82AA6815B2E465B856B9B46082DED89"><enum>(b)</enum><header display-inline="yes-display-inline">Reporting requirements</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H3EC5CE3CFBC24615A289A74797AA6018" section-type="subsequent-section"><enum>305.</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="no-display-inline">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.</text>
</section><section commented="no" display-inline="no-display-inline" id="HD3C6BC3B591B4A328045A6F56D35767B" section-type="subsequent-section"><enum>306.</enum><header display-inline="yes-display-inline">Amendment with respect to
misbranding</header><text display-inline="no-display-inline">Section 502 (21
U.S.C. 352) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H1240690DECC14820943C5FF4704C8BBE" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HB97EA58752944189AC357F47580F7AD5"><enum>(aa)</enum><text display-inline="yes-display-inline">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.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H1BEBA47CE7F141A1B708FEC2182D1A17" section-type="subsequent-section"><enum>307.</enum><header display-inline="yes-display-inline">Streamlined hiring authority to support
activities related to human generic drugs</header><text display-inline="no-display-inline">Section 714, as added by section 208 of this
Act, is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H135296E817F74A66892844E1A1AB11FD"><enum>(1)</enum><text display-inline="yes-display-inline">by amending subsection (b) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="H944B938216F64851A6B4961D5969A2AB" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H4ED802B7DEED4C5682E198AC9CC77462"><enum>(b)</enum><header display-inline="yes-display-inline">Activities described</header><text display-inline="yes-display-inline">The activities described in this subsection
are—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HE2806A7AE2894C1EBAD3C1F4154E7228"><enum>(1)</enum><text display-inline="yes-display-inline">activities under this Act related to the
process for the review of device applications (as defined in section 737(8));
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB04026C35D6546238938D6DD4853BDF7"><enum>(2)</enum><text display-inline="yes-display-inline">activities under this Act related to human
generic drug activities (as defined in section
744A).</text>
</paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H325473D090CB48DFAAEEF8FF4E565068"><enum>(2)</enum><text display-inline="yes-display-inline">by amending subsection (c) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="H7F59A1AE5288439CB26B1E94837919A1" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HB0DF13CA532A4FA491FBD3DAA0C8BA03"><enum>(c)</enum><header display-inline="yes-display-inline">Objectives specified</header><text display-inline="yes-display-inline">The objectives specified in this subsection
are—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H8B172A88443F4A248719A3C58947FA6F"><enum>(1)</enum><text display-inline="yes-display-inline">with respect to the activities under
subsection (b)(1), the goals referred to in section 738A(a)(1); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6A9858EB27D44BB2B0E5C5E7B96ED093"><enum>(2)</enum><text display-inline="yes-display-inline">with respect to the activities under
subsection (b)(2), the goals referred to in section
744C(a).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H551120C74A334339B6FB0D0F5A58075A" section-type="subsequent-section"><enum>308.</enum><header display-inline="yes-display-inline">Additional reporting
requirements</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="H9CA5AE062A81455DAEA8DCEF168F6B91" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H102944C4C84B4681B024A4E7787D54BB" section-type="subsequent-section"><enum>715.</enum><header display-inline="yes-display-inline">Reporting requirements</header>
<subsection commented="no" display-inline="no-display-inline" id="H4286818337E8442EAC6251611EB10960"><enum>(a)</enum><header display-inline="yes-display-inline">Generic drugs</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H112F5C3F193340CB889AB7C7D673C6AA"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1B1004E851FE427B8B4C5A5C8DA1529E"><enum>(2)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBA00A9D73F6846C99F38F18727CCFE0C"><enum>(3)</enum><text display-inline="yes-display-inline">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
<short-title>Food and Drug Administration Safety and
Innovation Act</short-title>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H21F1281A6D9F4F3CB4117EAF945D7F0B"><enum>(4)</enum><text display-inline="yes-display-inline">the number of applications described in
paragraph (3) on which the Food and Drug Administration took final regulatory
action in the previous fiscal
year.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>IV</enum><header display-inline="yes-display-inline">Fees relating to biosimilar biological
products</header>
<section commented="no" display-inline="no-display-inline" id="HA1F16A12D3254B8892E279244E116EB9" section-type="subsequent-section"><enum>401.</enum><header display-inline="yes-display-inline">Short title; finding</header>
<subsection commented="no" display-inline="no-display-inline" id="H35539C4F3B5144398FD6BCC172041BAB"><enum>(a)</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="yes-display-inline">This title may be cited as the
<quote><short-title>Biosimilar User Fee Act of
2012</short-title></quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H53129C63506E41EF868A50DF9235C815"><enum>(b)</enum><header display-inline="yes-display-inline">Finding</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H4B006FD0004B472AAC64204BB9B4AE85" section-type="subsequent-section"><enum>402.</enum><header display-inline="yes-display-inline">Fees relating to biosimilar biological
products</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="HACE05AFBE0D64F28BBB95F792A2D0927" style="OLC">
<part commented="no" id="HB7B38F02DDFF44868D694F35FB974EEE" level-type="subsequent"><enum>8</enum><header display-inline="yes-display-inline">FEES RELATING TO BIOSIMILAR BIOLOGICAL
PRODUCTS</header>
<section commented="no" display-inline="no-display-inline" id="H4E66ABE3DECB429298CA3BE6A8FBFE8F" section-type="subsequent-section"><enum>744G.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">For purposes of this part:</text>
<paragraph commented="no" display-inline="no-display-inline" id="H9C351D4BF0524EB09135237CFAE41830"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>adjustment factor</term>
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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEA2AA6FE78254A1F9B10367C6E844944"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>affiliate</term> means a
business entity that has a relationship with a second business entity if,
directly or indirectly—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H6B9E5124A599454AB018406BE8493230"><enum>(A)</enum><text display-inline="yes-display-inline">one business entity controls, or has the
power to control, the other business entity; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H604DD60D8C7849EBAF535D02148A6267"><enum>(B)</enum><text display-inline="yes-display-inline">a third party controls, or has power to
control, both of the business entities.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4E1B3ABDAAD24B35BA5E5C26D8AF09EB"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>biosimilar biological
product</term> means a product for which a biosimilar biological product
application has been approved.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2B9FDF4A91B64470A6FB77495E38F69E"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H1D43A357D40D4741AD30B7A0D967A710"><enum>(A)</enum><text display-inline="yes-display-inline">Subject to subparagraph (B), the term
<term>biosimilar biological product application</term> means an application for
licensure of a biological product under section 351(k) of the Public Health
Service Act.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF644FA482D4C40318904D4E2434129BD" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">Such term does not include—</text>
<clause commented="no" display-inline="no-display-inline" id="HAF31FD90675B4F689B5F9BDE47794EAC"><enum>(i)</enum><text display-inline="yes-display-inline">a supplement to such an application;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H81084E2DAA09498BA15A973844900096"><enum>(ii)</enum><text display-inline="yes-display-inline">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;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HEAA92F524E3D4FE0B75B47C3BBE68338"><enum>(iii)</enum><text display-inline="yes-display-inline">an application filed under section 351(k)
of the Public Health Service Act with respect to—</text>
<subclause commented="no" display-inline="no-display-inline" id="H0C5AFDB268D34918B5BD6A9967445A3D"><enum>(I)</enum><text display-inline="yes-display-inline">whole blood or a blood component for
transfusion;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HD5235F12A6F44D2591E1CBB3D6C7EA1E"><enum>(II)</enum><text display-inline="yes-display-inline">an allergenic extract product;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H6977D262F225493BA5B5F0E5BF39CB57"><enum>(III)</enum><text display-inline="yes-display-inline">an in vitro diagnostic biological product;
or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H4861A2B04B694B84B172E664866669B7"><enum>(IV)</enum><text display-inline="yes-display-inline">a biological product for further
manufacturing use only; or</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H9B21504A8A994E6B81311D4618B73E1A"><enum>(iv)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFA056512B15C478B83773FA4C6171D70"><enum>(5)</enum><text display-inline="yes-display-inline">The term <term>biosimilar biological
product development meeting</term> 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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H30ADF147436544178860DE3B21D81D61"><enum>(6)</enum><text display-inline="yes-display-inline">The term <term>biosimilar biological
product development program</term> means the program under this part for
expediting the process for the review of submissions in connection with
biosimilar biological product development.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H53AFD4F449A6410B99C7E8C8F459ECC4"><enum>(7)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H40B45BB2C9BD4F418E14244E01926A8F"><enum>(A)</enum><text display-inline="yes-display-inline">The term <term>biosimilar biological
product establishment</term> means a foreign or domestic place of
business—</text>
<clause commented="no" display-inline="no-display-inline" id="HCD4A8AD935DE42828C7EB02516052F2C" indent="up1"><enum>(i)</enum><text display-inline="yes-display-inline">that is at one general physical location
consisting of one or more buildings, all of which are within 5 miles of each
other; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H86C373ED7CD54ED9BDAF19BB709D8EB3" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">at which one or more biosimilar biological
products are manufactured in final dosage form.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5756CB2C5967475A8709636E009B55EC" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">For purposes of subparagraph (A)(ii), the
term <term>manufactured</term> does not include packaging.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9CD5DBB77B0F4030AB02BFF530F7B07C"><enum>(8)</enum><text display-inline="yes-display-inline">The term <term>biosimilar initial advisory
meeting</term>—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H9562A3016F254DCF928C8018C04F6DFF"><enum>(A)</enum><text display-inline="yes-display-inline">means a meeting, if requested, that is
limited to—</text>
<clause commented="no" display-inline="no-display-inline" id="H5D3E194D40A14391805F41C14EC69EEC"><enum>(i)</enum><text display-inline="yes-display-inline">a general discussion regarding whether
licensure under section 351(k) of the Public Health Service Act may be feasible
for a particular product; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HDB2BAFB00C724D62BB8C577EFEDEE672"><enum>(ii)</enum><text display-inline="yes-display-inline">if so, general advice on the expected
content of the development program; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1B5BD28620154573AC4E95545D95D1C6"><enum>(B)</enum><text display-inline="yes-display-inline">does not include any meeting that involves
substantive review of summary data or full study reports.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC4E58186A82E4E53978EE34F54C53DFB"><enum>(9)</enum><text display-inline="yes-display-inline">The term <term>costs of resources allocated
for the process for the review of biosimilar biological product
applications</term> means the expenses in connection with the process for the
review of biosimilar biological product applications for—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H07197862D04B414DA5B81F707586CF28"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7C3759FA7F424720998A447E690A215F"><enum>(B)</enum><text display-inline="yes-display-inline">management of information, and the
acquisition, maintenance, and repair of computer resources;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H36B28CB580E04D9AB63B60F90C58FD4A"><enum>(C)</enum><text display-inline="yes-display-inline">leasing, maintenance, renovation, and
repair of facilities and acquisition, maintenance, and repair of fixtures,
furniture, scientific equipment, and other necessary materials and supplies;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HED12F9D01F584C2BA8F1DB5947B29DC4"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE99C79E2E303424C8D9B72EBEB0A47C4"><enum>(10)</enum><text display-inline="yes-display-inline">The term <term>final dosage form</term>
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).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC7967C11DB7E4B5890E8FCBF60368F01"><enum>(11)</enum><text display-inline="yes-display-inline">The term <term>financial
hold</term>—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HC371845EB8BF4C7D94F72483528381CB"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HACE8077D5CFA4C3EA58BEFE6891564D3"><enum>(B)</enum><text display-inline="yes-display-inline">does not mean that any of the bases for a
<quote>clinical hold</quote> under section 505(i)(3) have been determined by
the Secretary to exist concerning the investigation.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H19BB993779FA4F248F7FEF451BE758CF"><enum>(12)</enum><text display-inline="yes-display-inline">The term <term>person</term> includes an
affiliate of such person.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB47FB629CADC4E168332674F8768B581"><enum>(13)</enum><text display-inline="yes-display-inline">The term <term>process for the review of
biosimilar biological product applications</term> 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:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H09A72210B80044D086F9C4DB03C2D3E7"><enum>(A)</enum><text display-inline="yes-display-inline">The activities necessary for the review of
submissions in connection with biosimilar biological product development,
biosimilar biological product applications, and supplements.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H29ACA3D75D604EF2B3473FCFCC81B0AE"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA0A86310F1A445D48D19948911FAD052"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0FB64C22BA6E43FA87F506DB8BBA8670"><enum>(D)</enum><text display-inline="yes-display-inline">Activities necessary for the release of
lots of biosimilar biological products under section 351(k) of the Public
Health Service Act.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9E21FF46F29E408FA15203BE8C859248"><enum>(E)</enum><text display-inline="yes-display-inline">Monitoring of research conducted in
connection with the review of biosimilar biological product
applications.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA48596EF7274406696BAB8FAC73F0DB4"><enum>(F)</enum><text display-inline="yes-display-inline">Postmarket safety activities with respect
to biologics approved under biosimilar biological product applications or
supplements, including the following activities:</text>
<clause commented="no" display-inline="no-display-inline" id="H8FC89E05D8C54B7B90AF49E6756573A0"><enum>(i)</enum><text display-inline="yes-display-inline">Collecting, developing, and reviewing
safety information on biosimilar biological products, including adverse-event
reports.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H5D33FFF8F1F34C61AF372BA2CC17BA05"><enum>(ii)</enum><text display-inline="yes-display-inline">Developing and using improved adverse-event
data-collection systems, including information technology systems.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H5A7F302F1492474486B81F2C6A548690"><enum>(iii)</enum><text display-inline="yes-display-inline">Developing and using improved analytical
tools to assess potential safety problems, including access to external data
bases.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H3452D010184743D0944BDF695C20DB95"><enum>(iv)</enum><text display-inline="yes-display-inline">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).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H853241D21A6945F198EC73AC991EBAA2"><enum>(v)</enum><text display-inline="yes-display-inline">Carrying out section 505(k)(5) (relating to
adverse-event reports and postmarket safety activities).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H25DE60892A174522ACB2E45C527D8E0E"><enum>(14)</enum><text display-inline="yes-display-inline">The term <term>supplement</term> 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.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H2807ECC21A5642548A20B152A047C47C" section-type="subsequent-section"><enum>744H.</enum><header display-inline="yes-display-inline">Authority to assess and use biosimilar
biological product fees</header>
<subsection commented="no" display-inline="no-display-inline" id="H0052E6B54FFE4AB0980CA5417ED3BD88"><enum>(a)</enum><header display-inline="yes-display-inline">Types of fees</header><text display-inline="yes-display-inline">Beginning in fiscal year 2013, the
Secretary shall assess and collect fees in accordance with this section as
follows:</text>
<paragraph commented="no" display-inline="no-display-inline" id="HCFFBCE885412465382D325EA7CF48EEC"><enum>(1)</enum><header display-inline="yes-display-inline">Biosimilar development program
fees</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H54D84D246FCF483C9DF9D009DB9909A1"><enum>(A)</enum><header display-inline="yes-display-inline">Initial biosimilar biological product
development fee</header>
<clause commented="no" display-inline="no-display-inline" id="H5D97CA9E396B435C82D4F47A174B65F1"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HF8200338FBAD45DFB4C0811BC134AF6A"><enum>(ii)</enum><header display-inline="yes-display-inline">Meeting request</header><text display-inline="yes-display-inline">The meeting request described in this
clause is a request for a biosimilar biological product development meeting for
a product.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H6485743E7C604B1BA7B7F93A696BAD40"><enum>(iii)</enum><header display-inline="yes-display-inline">Clinical protocol for IND</header><text display-inline="yes-display-inline">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 <quote>investigational
new drug application</quote>) describing an investigation that the Secretary
determines is intended to support a biosimilar biological product application
for a product.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HF304494776964AC4BCDACB4B44AAD8F3"><enum>(iv)</enum><header display-inline="yes-display-inline">Due Date</header><text display-inline="yes-display-inline">The initial biosimilar biological product
development fee shall be due by the earlier of the following:</text>
<subclause commented="no" display-inline="no-display-inline" id="HC53B2C8E93E24377B49B0A6E91281670"><enum>(I)</enum><text display-inline="yes-display-inline">Not later than 5 days after the Secretary
grants a request for a biosimilar biological product development
meeting.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H741A96D307D048CB9E610A3A128CF630"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="HF4E3453A6E4249509D59DA741301110C"><enum>(v)</enum><header display-inline="yes-display-inline">Transition rule</header><text display-inline="yes-display-inline">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:</text>
<subclause commented="no" display-inline="no-display-inline" id="H6BD5291167344C77A9AA29999F9BCFAC"><enum>(I)</enum><text display-inline="yes-display-inline">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.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H02626D0638C24289A411726F506756BA"><enum>(II)</enum><text display-inline="yes-display-inline">Not later than 5 days after the Secretary
grants a request for a biosimilar biological product development
meeting.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4DC19F30DCE14F6FBF5E18FE2EC7B684"><enum>(B)</enum><header display-inline="yes-display-inline">Annual biosimilar biological product
development fee</header>
<clause commented="no" display-inline="no-display-inline" id="H1D4B64ACC7DB41BD9433F6BB204A87F0"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 <quote>annual biosimilar biological
product development fee</quote>).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H568B041F24474B2EADC22D2BE3408F34"><enum>(ii)</enum><header display-inline="yes-display-inline">Due date</header><text display-inline="yes-display-inline">The annual biosimilar biological product
development program fee for each fiscal year will be due on the later
of—</text>
<subclause commented="no" display-inline="no-display-inline" id="H64988DD9271F49F5ACABB1E8CF726488"><enum>(I)</enum><text display-inline="yes-display-inline">the first business day on or after October
1 of each such year; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H29DBDBE1C0054512BFE40E1CFA892BBC"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H5581577A452545D8A9E14ED68A2114F6"><enum>(iii)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">The annual biosimilar development program
fee for each fiscal year will be due on the date specified in clause (ii),
unless the person has—</text>
<subclause commented="no" display-inline="no-display-inline" id="HE2D200F1CC9740F7A0AC1859954170E0"><enum>(I)</enum><text display-inline="yes-display-inline">submitted a marketing application for the
biological product that was accepted for filing; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H78C7CEE793544819A522BEDB0C36E043"><enum>(II)</enum><text display-inline="yes-display-inline">discontinued participation in the
biosimilar biological product development program for the product under
subparagraph (C).</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H14516E7C024740999216E94CEEA4A643"><enum>(C)</enum><header display-inline="yes-display-inline">Discontinuation of fee
obligation</header><text display-inline="yes-display-inline">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—</text>
<clause commented="no" display-inline="no-display-inline" id="HD9F8028455034877A71B1486904A12E4"><enum>(i)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H05A94269D89E47F8AC2A054910845D81"><enum>(ii)</enum><text display-inline="yes-display-inline">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).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H25F92A17895942EB878797133730FBD7"><enum>(D)</enum><header display-inline="yes-display-inline">Reactivation fee</header>
<clause commented="no" display-inline="no-display-inline" id="H88049CBF0C2C433B9ED75FD9518F9D46"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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
<quote>reactivation fee</quote>) by the earlier of the following:</text>
<subclause commented="no" display-inline="no-display-inline" id="H7047CC3285FF4D52819E5E747548B462"><enum>(I)</enum><text display-inline="yes-display-inline">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).</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HD0B9AD4924134EA097E03A4A8268CD42"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="HD3DFB4B948CD493591F5834606416793"><enum>(ii)</enum><header display-inline="yes-display-inline">Application of annual fee</header><text display-inline="yes-display-inline">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).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H87FBBF8E105D4EC0B1B205B66A451503"><enum>(E)</enum><header display-inline="yes-display-inline">Effect of failure to pay biosimilar
development program fees</header>
<clause commented="no" display-inline="no-display-inline" id="H68D75311677A4160850EC35CFA27BACE"><enum>(i)</enum><header display-inline="yes-display-inline">No biosimilar biological product
development meetings</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H04CC3659448046F194A679C8101EF449"><enum>(ii)</enum><header display-inline="yes-display-inline">No receipt of investigational new drug
applications</header><text display-inline="yes-display-inline">Except in
extraordinary circumstances, the Secretary shall not consider an
investigational new drug application to have been received under section
505(i)(2) if—</text>
<subclause commented="no" display-inline="no-display-inline" id="H144B6FC2FA124F1C82B0E1BAEA3C4883"><enum>(I)</enum><text display-inline="yes-display-inline">the Secretary determines that the
investigation is intended to support a biosimilar biological product
application; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HBE93E13D2BDB439CA7C464EEBC809C53"><enum>(II)</enum><text display-inline="yes-display-inline">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).</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H3C641E7CE418482F93B45B1513A4C367"><enum>(iii)</enum><header display-inline="yes-display-inline">Financial
hold</header><text display-inline="yes-display-inline">Notwithstanding section
505(i)(2), except in extraordinary circumstances, the Secretary shall prohibit
the sponsor of a clinical investigation from continuing the investigation
if—</text>
<subclause commented="no" display-inline="no-display-inline" id="H2832D7D51FD3433D8160E264170C46F8"><enum>(I)</enum><text display-inline="yes-display-inline">the Secretary determines that the
investigation is intended to support a biosimilar biological product
application; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H336F61EA519C47289A3C5FD5473BA3D6"><enum>(II)</enum><text display-inline="yes-display-inline">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).</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H2B9F8648AA5B41CB9EE8BD45118CCAB0"><enum>(iv)</enum><header display-inline="yes-display-inline">No acceptance of biosimilar biological
product applications or supplements</header><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC793F02E3928490EB2A0D48D865853AA"><enum>(F)</enum><header display-inline="yes-display-inline">Limits regarding biosimilar development
program fees</header>
<clause commented="no" display-inline="no-display-inline" id="H7C0C9B38C92C4CC48DC6E63D8F0BB28F"><enum>(i)</enum><header display-inline="yes-display-inline">No refunds</header><text display-inline="yes-display-inline">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).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H5EC376FD57DD4103A54E4E8166AFBD38"><enum>(ii)</enum><header display-inline="yes-display-inline">No waivers, exemptions, or
reductions</header><text display-inline="yes-display-inline">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).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0DCA8CF631114CFBBA933B34BC02130A"><enum>(2)</enum><header display-inline="yes-display-inline">Biosimilar biological product application
and supplement fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H1DBA227C5A164ADE9F090F7D10D3894D"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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:</text>
<clause commented="no" display-inline="no-display-inline" id="HF13636258EA44B4290D7F7FB07578B60"><enum>(i)</enum><text display-inline="yes-display-inline">A fee for a biosimilar biological product
application that is equal to—</text>
<subclause commented="no" display-inline="no-display-inline" id="HD5780A3DD27E4BDD91D09AA1D1076F89"><enum>(I)</enum><text display-inline="yes-display-inline">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</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H0BE1E974DF224404B9D996F80232616D"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H773F65BCA9C44F93B3F230C04F57D9DD"><enum>(ii)</enum><text display-inline="yes-display-inline">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—</text>
<subclause commented="no" display-inline="no-display-inline" id="H9D33CC92B8224A8C8A5FF83F3900387C"><enum>(I)</enum><text display-inline="yes-display-inline">half of the amount of the fee established
under subsection (b)(1)(D) for a biosimilar biological product application;
minus</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H38A527EDC9304DCFA8A4B0283CD1A4DB"><enum>(II)</enum><text display-inline="yes-display-inline">the cumulative amount of fees paid, if any,
under subparagraphs (A), (B), and (D) of paragraph (1) for that product.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H51847BA0BF254C03B9E8CF3B4D46C65C"><enum>(iii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HECB3C32BE0D54007B0812637C3E72CEC"><enum>(B)</enum><header display-inline="yes-display-inline">Reduction in fees</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3741D71420D443E4AD44BB3F02B12DEA"><enum>(C)</enum><header display-inline="yes-display-inline">Payment due date</header><text display-inline="yes-display-inline">Any fee required by subparagraph (A) shall
be due upon submission of the application or supplement for which such fee
applies.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H283674DCA4134256B38C9F59065592BA"><enum>(D)</enum><header display-inline="yes-display-inline">Exception for previously filed application
or supplement</header><text display-inline="yes-display-inline">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).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H11BB09051CBA4C888EC9CE7BA2A7B1E9"><enum>(E)</enum><header display-inline="yes-display-inline">Refund of application fee if application
refused for filing or withdrawn before filing</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC3B6150F88044BB78264555818083E61"><enum>(F)</enum><header display-inline="yes-display-inline">Fees for applications previously refused
for filing or withdrawn before filing</header><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3F8171BB22C3477B9573199770AED587"><enum>(3)</enum><header display-inline="yes-display-inline">Biosimilar biological product establishment
fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H8EABD5C4F82940EA91EA015E61407916"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD099CC18DC4A482BBD261F0780E2307A"><enum>(B)</enum><header display-inline="yes-display-inline">Assessment in fiscal years</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H53739078AC3A4A2C9B72DF7479928182"><enum>(C)</enum><header display-inline="yes-display-inline">Due date</header><text display-inline="yes-display-inline">The establishment fee for a fiscal year
shall be due on the later of—</text>
<clause commented="no" display-inline="no-display-inline" id="H43084B99C16040D09F49838C3D9FF5C7"><enum>(i)</enum><text display-inline="yes-display-inline">the first business day on or after October
1 of such fiscal year; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H534EA00EDA69408AB82C89E43D6CF3F8"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBE5AC1F70B5F41EE9E8716A8A265B6E0"><enum>(D)</enum><header display-inline="yes-display-inline">Application to establishment</header>
<clause commented="no" display-inline="no-display-inline" id="H9DEADDE432FB4119B2E9741BD73BE5E5"><enum>(i)</enum><text display-inline="yes-display-inline">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).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H11B47119930541A3A40891FAA5712163"><enum>(ii)</enum><text display-inline="yes-display-inline">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).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5C822EA153F14F7EB2790C6BF03C4894"><enum>(E)</enum><header display-inline="yes-display-inline">Exception for new products</header><text display-inline="yes-display-inline">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—</text>
<clause commented="no" display-inline="no-display-inline" id="H5A3FAF83369641AF8986C251368B7C21"><enum>(i)</enum><text display-inline="yes-display-inline">that did not manufacture the biosimilar
biological product in the previous fiscal year; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H6E26BAFDE89C4DF6BEE725A1A2A68079"><enum>(ii)</enum><text display-inline="yes-display-inline">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,</text>
</clause><continuation-text commented="no" continuation-text-level="subparagraph">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.</continuation-text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB1FAF42CA86D4A6E8BAAA532F514E91A"><enum>(4)</enum><header display-inline="yes-display-inline">Biosimilar biological product fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H44041EA4264747C2AEDC409B220678F4"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB20601786B204E2DB8DC036F6C3C68EE"><enum>(B)</enum><header display-inline="yes-display-inline">Due date</header><text display-inline="yes-display-inline">The biosimilar biological product fee for a
fiscal year shall be due on the later of—</text>
<clause commented="no" display-inline="no-display-inline" id="H5E139217E55F445F86823486253A473A"><enum>(i)</enum><text display-inline="yes-display-inline">the first business day on or after October
1 of each such year; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H4D53C1DAA45B4D489E6D2EC9209750A7"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0F0BAC3A70CB49AAADCCDC8641F19B92"><enum>(C)</enum><header display-inline="yes-display-inline">One fee per product per year</header><text display-inline="yes-display-inline">The biosimilar biological product fee shall
be paid only once for each product for each fiscal year.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H0C2885F6A5774534B8BC16049FC5639C"><enum>(b)</enum><header display-inline="yes-display-inline">Fee setting and amounts</header>
<paragraph commented="no" display-inline="no-display-inline" id="H7BEEE9D42E4A4C14BA2891C10AD123A6"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H4342B580118E4A95B52AD4B4A8F467B1"><enum>(A)</enum><header display-inline="yes-display-inline">Initial biosimilar biological product
development fee</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9D67EC844BDA44CCBB65919A4EAA8A8C"><enum>(B)</enum><header display-inline="yes-display-inline">Annual biosimilar biological product
development fee</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE4879E36154744C39FAF7AFDCF34A27A"><enum>(C)</enum><header display-inline="yes-display-inline">Reactivation fee</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEFBDBE3A9A714DA3ADB68D3660D72D13"><enum>(D)</enum><header display-inline="yes-display-inline">Biosimilar biological product application
fee</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDADD488A422B4BDAB95D0BBF0547D73C"><enum>(E)</enum><header display-inline="yes-display-inline">Biosimilar biological product establishment
fee</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4D82C9B29B624E7E9FB5277DE4011FC2"><enum>(F)</enum><header display-inline="yes-display-inline">Biosimilar biological product
fee</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBD309EFA53244DE6A35EC6E05ADAE676"><enum>(2)</enum><header display-inline="yes-display-inline">Limit</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H2338A353E6DC48528CAF633EC000B71E"><enum>(c)</enum><header display-inline="yes-display-inline">Application fee waiver for small
business</header>
<paragraph commented="no" display-inline="no-display-inline" id="H7BBD47DD491B49EC9C0F8DE8F64E755E"><enum>(1)</enum><header display-inline="yes-display-inline">Waiver of application fee</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HAA6A12204BC647738B0A7FBC64B10D8A"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD7CA0FF49D724495902D64C630CC4C01"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6F0F1638B5E24F8E9419A037F06E188D"><enum>(2)</enum><header display-inline="yes-display-inline">Considerations</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HCD1EE104C30747C9901C171558533E3A"><enum>(3)</enum><header display-inline="yes-display-inline">Small business defined</header><text display-inline="yes-display-inline">In this subsection, the term <term>small
business</term> 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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HE426D82450C146068B93B45076565FD6"><enum>(d)</enum><header display-inline="yes-display-inline">Effect of failure To pay fees</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H2C0C7AA690AA40FD81582FEB5190588D"><enum>(e)</enum><header display-inline="yes-display-inline">Crediting and availability of fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="HC0259B9C49BC42F2AF6E86D8814474E4"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H21D6FFB95ED443E5BF3227FE6229582A"><enum>(2)</enum><header display-inline="yes-display-inline">Collections and appropriation acts</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HB2AEE4F9B6614DD2AB4D635C692E9255"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE34E7C1093C645AB80A0D37CEA25405D"><enum>(B)</enum><header display-inline="yes-display-inline">Use of fees and limitation</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7DF9C389930F442592BE908DD5DCFA4E"><enum>(C)</enum><header display-inline="yes-display-inline">Fee collection during first program
year</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H810486117EA2414BBD5C6EB1130C85B2"><enum>(D)</enum><header display-inline="yes-display-inline">Provision for early payments in subsequent
years</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5467BC1B64B84E278C8E196FDE2EE18C"><enum>(3)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H1F01526C42794F64AD6BA6D7FD1E5728"><enum>(f)</enum><header display-inline="yes-display-inline">Collection of unpaid fees</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H416A997883AF498192837955A55C8699"><enum>(g)</enum><header display-inline="yes-display-inline">Written requests for waivers and
refunds</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HAD24C39373F04A539619EE78D4144F3B"><enum>(h)</enum><header display-inline="yes-display-inline">Construction</header><text display-inline="yes-display-inline">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.</text>
</subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H00F20B2253BE43229431007C1E09EDF7" section-type="subsequent-section"><enum>403.</enum><header display-inline="yes-display-inline">Reauthorization; reporting
requirements</header><text display-inline="no-display-inline">Part 8 of
subchapter C of chapter VII, as added by section 402, is further amended by
inserting after section 744H the following:</text>
<quoted-block display-inline="no-display-inline" id="H4E9208CF8AEC4A0A8274BDC6D03A7813" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HF8C6DD7110E544AF8193E0DE40A9EDA8" section-type="subsequent-section"><enum>744I.</enum><header display-inline="yes-display-inline">Reauthorization; reporting
requirements</header>
<subsection commented="no" display-inline="no-display-inline" id="HDCFBC0DF0EC848F4AB7E23193E2CB400"><enum>(a)</enum><header display-inline="yes-display-inline">Performance report</header><text display-inline="yes-display-inline">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
<short-title>Biosimilar User Fee Act of 2012</short-title>
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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H94DD632B6B69415BA88714FC0E6B0684"><enum>(b)</enum><header display-inline="yes-display-inline">Fiscal report</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HA2466CBBA9F346E68AE32FCDA5AE4E73"><enum>(c)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H7D62FFE91A0946C1996F9F13DECEB023"><enum>(d)</enum><header display-inline="yes-display-inline">Study</header>
<paragraph commented="no" display-inline="no-display-inline" id="H10429951CA894B3DAA873E258EAFECDC"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9B98FD21316544F5B5182664E1A25D25"><enum>(2)</enum><header display-inline="yes-display-inline">Interim results</header><text display-inline="yes-display-inline">Not later than June 1, 2015, the Secretary
shall publish, for public comment, interim results of the study described under
paragraph (1).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9E06749FBD974ADFA91683A9B421A267"><enum>(3)</enum><header display-inline="yes-display-inline">Final results</header><text display-inline="yes-display-inline">Not later than September 30, 2016, the
Secretary shall publish, for public comment, the final results of the study
described under paragraph (1).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF19F098A7CAE4790A7C036A0B7ED6CD1"><enum>(e)</enum><header display-inline="yes-display-inline">Reauthorization</header>
<paragraph commented="no" display-inline="no-display-inline" id="H9CEC86532FCD4FC486A6D922B9BB167A"><enum>(1)</enum><header display-inline="yes-display-inline">Consultation</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H127AB3798DCE489DA6E2C70B2A3EDD83"><enum>(A)</enum><text display-inline="yes-display-inline">the Committee on Energy and Commerce of the
House of Representatives;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H03D40C82A2164F058AB3822EDF587A4F"><enum>(B)</enum><text display-inline="yes-display-inline">the Committee on Health, Education, Labor,
and Pensions of the Senate;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HCD91DC6134384A48AE8DCC694A6E4939"><enum>(C)</enum><text display-inline="yes-display-inline">scientific and academic experts;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H37BBE8EF3629442FA2D385BDFF00CF5E"><enum>(D)</enum><text display-inline="yes-display-inline">health care professionals;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HCACBBF6433CE41A8AEC40F91684078C1"><enum>(E)</enum><text display-inline="yes-display-inline">representatives of patient and consumer
advocacy groups; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H296108974CB44AD6AF4A9D293B937748"><enum>(F)</enum><text display-inline="yes-display-inline">the regulated industry.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF992248AD4DF411CB867E3D728960336"><enum>(2)</enum><header display-inline="yes-display-inline">Public review of
recommendations</header><text display-inline="yes-display-inline">After
negotiations with the regulated industry, the Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HF5306084793E464D88166A6406483392"><enum>(A)</enum><text display-inline="yes-display-inline">present the recommendations developed under
paragraph (1) to the congressional committees specified in such
paragraph;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF2D325A0879D4978A9D457BB30EAD51C"><enum>(B)</enum><text display-inline="yes-display-inline">publish such recommendations in the Federal
Register;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0F1A0F36E37A40F481DBF4BEFC638DAA"><enum>(C)</enum><text display-inline="yes-display-inline">provide for a period of 30 days for the
public to provide written comments on such recommendations;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8B08C7C221C945DB852B717B97045B1F"><enum>(D)</enum><text display-inline="yes-display-inline">hold a meeting at which the public may
present its views on such recommendations; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE167860E0A4143A88C0E84A79D21C7A8"><enum>(E)</enum><text display-inline="yes-display-inline">after consideration of such public views
and comments, revise such recommendations as necessary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEB56567AF4A845B7A0BE514AD425ACEB"><enum>(3)</enum><header display-inline="yes-display-inline">Transmittal of
recommendations</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H7E52F1D30FFA4617A1C387A8845E026A" section-type="subsequent-section"><enum>404.</enum><header display-inline="yes-display-inline">Sunset dates</header>
<subsection commented="no" display-inline="no-display-inline" id="H73C9A76B4E6046EBB5BF11C4256A31F7"><enum>(a)</enum><header display-inline="yes-display-inline">Authorization</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H5E39B90F99024218B1EDEF462395C11F"><enum>(b)</enum><header display-inline="yes-display-inline">Reporting requirements</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H871434378F1946A09AE6A2915734B456" section-type="subsequent-section"><enum>405.</enum><header display-inline="yes-display-inline">Effective date</header>
<subsection commented="no" display-inline="no-display-inline" id="H8E67AEECD46A4BB6B124D59619B78094"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Except as provided under subsection (b),
the amendments made by this title shall take effect on the later of—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H3496487BD483477EB20156D00F613032"><enum>(1)</enum><text display-inline="yes-display-inline">October 1, 2012; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA239528B2E874F2FB43F5B2D224FC1E3"><enum>(2)</enum><text display-inline="yes-display-inline">the date of the enactment of this
title.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H7C9C67BA381C4E8AB1615D8F79ECFA55"><enum>(b)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H015F0786110E4E68BC8761BF571E5C9D" section-type="subsequent-section"><enum>406.</enum><header display-inline="yes-display-inline">Savings
clause</header><text display-inline="no-display-inline">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.</text>
</section><section commented="no" display-inline="no-display-inline" id="H38C9C595F9524FD9BE63608E01B86BAE" section-type="subsequent-section"><enum>407.</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="no-display-inline">Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is
amended by striking <quote>or (k)</quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="H33F138CCF2854CDAB0B3E12816A8001F" section-type="subsequent-section"><enum>408.</enum><header display-inline="yes-display-inline">Additional reporting
requirements</header><text display-inline="no-display-inline">Section 715, as
added by section 308 of this Act, is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H2C0B8E303FEC41BEAF3C55DF24024033" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HBCF82439A77A447A8171A42D3259B4A5"><enum>(b)</enum><header display-inline="yes-display-inline">Biosimilar biological products</header>
<paragraph commented="no" display-inline="no-display-inline" id="HB5110731820548FFB81BF18AD3152926"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HE9F745A90F074393B50FC93D7EAA2972"><enum>(A)</enum><text display-inline="yes-display-inline">the number of applications for approval
filed under section 351(k) of the Public Health Service Act; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7031DA99E26B4A93BECA7E5D897998B1"><enum>(B)</enum><text display-inline="yes-display-inline">the percentage of applications described in
subparagraph (A) that were approved by the Secretary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H57D1509787F240D7A5418866C696298D"><enum>(2)</enum><header display-inline="yes-display-inline">Additional information</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>V</enum><header display-inline="yes-display-inline">Pediatric drugs and devices</header>
<section commented="no" display-inline="no-display-inline" id="HBA5BAA0B9E784C168E8EBA3F35A51FA8" section-type="subsequent-section"><enum>501.</enum><header display-inline="yes-display-inline">Permanence</header>
<subsection commented="no" display-inline="no-display-inline" id="HC0AB0F5CBFD9463ABD0A00A89880BEAC"><enum>(a)</enum><header display-inline="yes-display-inline">Pediatric studies of drugs</header><text display-inline="yes-display-inline">Section 505A (21 U.S.C. 355a) is amended by
striking subsection (q) (relating to a sunset).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H53B9A1712BC84EC79C798AB11B92777C"><enum>(b)</enum><header display-inline="yes-display-inline">Research into pediatric uses for drugs and
biological products</header><text display-inline="yes-display-inline">Section
505B (21 U.S.C. 355c) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H8BB5601E23844BC48CF4C2CDFB4E1112"><enum>(1)</enum><text display-inline="yes-display-inline">by striking subsection (m); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3CA18262D9CB4D7DA3E7B54514B72EB6"><enum>(2)</enum><text display-inline="yes-display-inline">by redesignating subsection (n) as
subsection (m).</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H7214935E619842879971635B95B7EEAF" section-type="subsequent-section"><enum>502.</enum><header display-inline="yes-display-inline">Written requests</header>
<subsection commented="no" display-inline="no-display-inline" id="H1B29CF5456234784AD4D9A85BAF46B91"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header>
<paragraph commented="no" display-inline="no-display-inline" id="HF5908F2284664439B065719377DA8DFE"><enum>(1)</enum><header display-inline="yes-display-inline">Federal Food, Drug, and Cosmetic
Act</header><text display-inline="yes-display-inline">Subsection (h) of section
505A (21 U.S.C. 355a) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H1D6187A8BF4143F1943387B4DD85B06F" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HAEB859F66C3A44FFAE10B631EBA1A291"><enum>(h)</enum><header display-inline="yes-display-inline">Relationship to pediatric research
requirements</header><text display-inline="yes-display-inline">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.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDE055E16A16F4EA0933AAD8EB94F14EE"><enum>(2)</enum><header display-inline="yes-display-inline">Public Health Service Act</header><text display-inline="yes-display-inline">Section 351(m)(1) of the Public Health
Service Act (42 U.S.C. 262(m)(1)) is amended by striking <quote>(f), (i), (j),
(k), (l), (p), and (q)</quote> and inserting <quote>(f), (h), (i), (j), (k),
(l), (n), and (p)</quote>.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HFD5CF50C40F74E418EDE29762C21C642"><enum>(b)</enum><header display-inline="yes-display-inline">Neonates</header><text display-inline="yes-display-inline">Subparagraph (A) of section 505A(d)(1) is
amended by adding at the end the following: <quote>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.</quote>.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H674EEABE93D743D2B27112A335542639" section-type="subsequent-section"><enum>503.</enum><header display-inline="yes-display-inline">Communication with Pediatric Review
Committee</header><text display-inline="no-display-inline">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 <quote>Secretary</quote>) 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.</text>
</section><section commented="no" display-inline="no-display-inline" id="H690C119A6779426DB2739DB4492F39EF" section-type="subsequent-section"><enum>504.</enum><header display-inline="yes-display-inline">Access
to data</header><text display-inline="no-display-inline">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)).</text>
</section><section commented="no" display-inline="no-display-inline" id="HCD6A64EA60BA494D88A2819D91E747C8" section-type="subsequent-section"><enum>505.</enum><header display-inline="yes-display-inline">Ensuring the completion of pediatric
studies</header>
<subsection commented="no" display-inline="no-display-inline" id="HEFC1AC49EB9F4A81BFBD873B2B6BA09C"><enum>(a)</enum><header display-inline="yes-display-inline">Extension of deadline for deferred
studies</header><text display-inline="yes-display-inline">Section 505B (21
U.S.C. 355c) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HD75876823D7B44E2AC5C9AC8916A9E94"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)(3)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HE224A5CF2B7A47928BD3FA90411E6120"><enum>(A)</enum><text display-inline="yes-display-inline">by redesignating subparagraph (B) as
subparagraph (C);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5FF66FC187A0443FB8496AF19552CDB6"><enum>(B)</enum><text display-inline="yes-display-inline">by inserting after subparagraph (A) the
following:</text>
<quoted-block display-inline="no-display-inline" id="HBEC497AB7D1440EE96B68749C2D9DE45" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H43945E46FA154F0BB6D2E7A7D2BE294F"><enum>(B)</enum><header display-inline="yes-display-inline">Deferral extension</header>
<clause commented="no" display-inline="no-display-inline" id="HA6A1F233A2A54354B2250897D8DC1B17"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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—</text>
<subclause commented="no" display-inline="no-display-inline" id="H641C40D6858E44349CBE4474D8C07416"><enum>(I)</enum><text display-inline="yes-display-inline">the Secretary determines that the
conditions described in subclause (II) or (III) of subparagraph (A)(i) continue
to be met; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H9C0D16B291654C62AD54CB2D6F1C75B3"><enum>(II)</enum><text display-inline="yes-display-inline">the applicant submits a new timeline under
subparagraph (A)(ii)(IV) and any significant updates to the information
required under subparagraph (A)(ii).</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H2A674912200B435EB172B62821229842"><enum>(ii)</enum><header display-inline="yes-display-inline">Timing and information</header><text display-inline="yes-display-inline">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
<short-title>Food and Drug Administration Safety and
Innovation Act</short-title> 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.</text>
</clause></subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4ECB697FAAED42ADB1A042D143EDA50A"><enum>(C)</enum><text display-inline="yes-display-inline">in subparagraph (C), as so
redesignated—</text>
<clause commented="no" display-inline="no-display-inline" id="H58263C3E24BF42B58C390A0D48420851"><enum>(i)</enum><text display-inline="yes-display-inline">in clause (i), by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HD55344E71E6347BCA9A5B84AF0E36F1E" style="OLC">
<subclause commented="no" display-inline="no-display-inline" id="H5BFFD236B2234ED09A354C8836E65B65"><enum>(III)</enum><text display-inline="yes-display-inline">Projected completion date for pediatric
studies.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HF64F77E02FFA4F608F2EFC52BA978C92"><enum>(IV)</enum><text display-inline="yes-display-inline">The reason or reasons why a deferral or
deferral extension continues to be
necessary.</text>
</subclause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause><clause commented="no" display-inline="no-display-inline" id="HDAC619818C5F435E903FAD0FAC1B6C1C"><enum>(ii)</enum><text display-inline="yes-display-inline">by amending clause (ii) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="HA8F34FCA67FF456A9D7EA0F06D11835C" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="H7B100F217FE841F49F0B612C8D37CFDA"><enum>(ii)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">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—</text>
<subclause commented="no" display-inline="no-display-inline" id="H841FDE2C887A42698846A1B00965A08B"><enum>(I)</enum><text display-inline="yes-display-inline">such information;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HDED060849456448AB449086733389E82"><enum>(II)</enum><text display-inline="yes-display-inline">the name of the applicant for the product
subject to the assessment;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H5F2D2C9B198040C980B57F1B8A04FF61"><enum>(III)</enum><text display-inline="yes-display-inline">the date on which the product was approved;
and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HD94B1A2C21244AFD8C1412EEFD69C3C8"><enum>(IV)</enum><text display-inline="yes-display-inline">the date of each deferral or deferral
extension under this paragraph for the
product.</text>
</subclause></clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H910B0E06810646A982A09824D67C0094"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (f)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H9E459FFE825D4FC3BC42F1E9EA445236"><enum>(A)</enum><text display-inline="yes-display-inline">in the subsection heading, by inserting
<quote><header-in-text level="subsection" style="OLC">Deferral
Extensions,</header-in-text></quote> after <quote><header-in-text level="subsection" style="OLC">Deferrals,</header-in-text></quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H18720C7E9C69428CBFE38FE02CF5E029"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1), by inserting <quote>,
deferral extension, </quote> after <quote>deferral</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HABFA9C31DDF544839A86FE3B414F19A9"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text>
<clause commented="no" display-inline="no-display-inline" id="HDDF195019F1343F68FD99D7EF438F7A6"><enum>(i)</enum><text display-inline="yes-display-inline">in the paragraph heading, by inserting
<quote><header-in-text level="paragraph" style="OLC">deferral
extensions,</header-in-text></quote> after <quote><header-in-text level="paragraph" style="OLC">deferrals,</header-in-text></quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HAC6BDB3D25234EAFB3561D9F20B57075"><enum>(ii)</enum><text display-inline="yes-display-inline">by inserting <quote>, deferral extensions,
</quote> after <quote>deferrals</quote>.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H0A5EED6132F143ECB5B0F2D946FEF7E3"><enum>(b)</enum><header display-inline="yes-display-inline">Tracking of extensions; annual
information</header><text display-inline="yes-display-inline">Section
505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H2D7B62E2A8A141D1A5056F8EAE8B0F4B" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H3DE0B2EC84D04DC9913B1C6DB66D03B3"><enum>(D)</enum><text display-inline="yes-display-inline">aggregated on an annual basis—</text>
<clause commented="no" display-inline="no-display-inline" id="HA16303C9ED1B4E77BE49735CA9314A21"><enum>(i)</enum><text display-inline="yes-display-inline">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;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H7FB094F8E36A4E2E9DA63E3E9A7D8A8D"><enum>(ii)</enum><text display-inline="yes-display-inline">the timeline for completion of the
assessments; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HBE90482E02E541A2B02040D21B7CF4C3"><enum>(iii)</enum><text display-inline="yes-display-inline">the number of assessments completed and
pending;</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H510D441A8E584B58A97D4D03A38CF9F9"><enum>(c)</enum><header display-inline="yes-display-inline">Action on failure To complete
studies</header>
<paragraph commented="no" display-inline="no-display-inline" id="H5F24C546FCC1434E98ED04C0EDDC7CE2"><enum>(1)</enum><header display-inline="yes-display-inline">Issuance of letter</header><text display-inline="yes-display-inline">Subsection (d) of section 505B (21 U.S.C.
355c) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H5860987F4F59446E82F0BF34772C0CBF" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HB426FCA7F19A42FEB4B7B97C3C9C7882"><enum>(d)</enum><header display-inline="yes-display-inline">Submission of assessments</header><text display-inline="yes-display-inline">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:</text>
<paragraph commented="no" display-inline="no-display-inline" id="HD3E60800299141EA9BB2C0066485842F"><enum>(1)</enum><text display-inline="yes-display-inline">Beginning 270 days after the date of
enactment of the <short-title>Food and Drug Administration
Safety and Innovation Act</short-title>, 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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4EE6266B71DE4EBB9CBC728F01091727"><enum>(2)</enum><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HC152A514E71C4362AF9DC799B8DCDC6E"><enum>(A)</enum><text display-inline="yes-display-inline">to withdraw approval for a drug under
section 505(e); or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9F83BD0F33E44A8EB5834493C8CBC405"><enum>(B)</enum><text display-inline="yes-display-inline">to revoke the license for a biological
product under section 351 of the Public Health Service
Act.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBCC528DC94C74B89BB55BFB746E2B621"><enum>(2)</enum><header display-inline="yes-display-inline">Tracking of letters issued</header><text display-inline="yes-display-inline">Subparagraph (D) of section 505B(f)(6) (21
U.S.C. 355c(f)(6)), as amended by subsection (b), is further amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H2388BDE8C5B4421D8161D924EC1C9FD6"><enum>(A)</enum><text display-inline="yes-display-inline">in clause (ii), by striking <quote>;
and</quote> and inserting a semicolon;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0BA39B7901ED45EAADCD0957E28880EA"><enum>(B)</enum><text display-inline="yes-display-inline">in clause (iii), by adding
<quote>and</quote> at the end; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H09D1CF1FCFD64AE6B4F8AAF099DEEF4F"><enum>(C)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HBF25230A56A7485B9CC93E275114D395" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="HEFF1340845B8436DBA6943B6AB2D2341"><enum>(iv)</enum><text display-inline="yes-display-inline">the number of postmarket non-compliance
letters issued pursuant to subsection (d), and the recipients of such
letters;</text>
</clause><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H7D67BF7B171442E888384B3A24D56269" section-type="subsequent-section"><enum>506.</enum><header display-inline="yes-display-inline">Pediatric study plans</header>
<subsection commented="no" display-inline="no-display-inline" id="HC716F37B2321430495B540B69DFB42C1"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subsection (e) of section 505B (21 U.S.C.
355c) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H13717D9DBA5F4764AE32424A097398E5" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H2C105AD26667409DA7E25E22353FD66B"><enum>(e)</enum><header display-inline="yes-display-inline">Pediatric study plans</header>
<paragraph commented="no" display-inline="no-display-inline" id="H2E20556824E04C40BA12877E8D5A6E02"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H953B77202F354AA6905AE641A1974EB1"><enum>(2)</enum><header display-inline="yes-display-inline">Timing; content; meeting</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HC37462D74283478799DFC4147F0B2855"><enum>(A)</enum><header display-inline="yes-display-inline">Timing</header><text display-inline="yes-display-inline">An applicant shall submit the initial
pediatric plan under paragraph (1)—</text>
<clause commented="no" display-inline="no-display-inline" id="H0E7EF16804994D16860E149E54B07A3D"><enum>(i)</enum><text display-inline="yes-display-inline">before the date on which the applicant
submits the assessments under subsection (a)(2); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H0DB51AE299864D77A42D3BA5D3B819EA"><enum>(ii)</enum><text display-inline="yes-display-inline">not later than—</text>
<subclause commented="no" display-inline="no-display-inline" id="H416280881F0A495A8AFC8DCC2996A94D"><enum>(I)</enum><text display-inline="yes-display-inline">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</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H131511187E3F437083A6BBDDB40ADDE0"><enum>(II)</enum><text display-inline="yes-display-inline">such other time as may be agreed upon
between the Secretary and the applicant.</text>
</subclause></clause><continuation-text commented="no" continuation-text-level="subparagraph">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.</continuation-text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5BF4E90C3AFF44C4A0ACC9B90E1F52B0"><enum>(B)</enum><header display-inline="yes-display-inline">Content of initial plan</header><text display-inline="yes-display-inline">The initial pediatric study plan shall
include—</text>
<clause commented="no" display-inline="no-display-inline" id="H315EE45729264FC0A5022BD5FF7F9A01"><enum>(i)</enum><text display-inline="yes-display-inline">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);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H8844073F750D476083BF6596E3D93ED3"><enum>(ii)</enum><text display-inline="yes-display-inline">any request for a deferral, partial waiver,
or waiver under this section, if applicable, along with any supporting
information; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HC931B70C84514940A9EDBDAB71BB3CE0"><enum>(iii)</enum><text display-inline="yes-display-inline">other information specified in the
regulations promulgated under paragraph (7).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H127CDC9FF8474F1CA0CB1F4B6B60E0E8"><enum>(C)</enum><header display-inline="yes-display-inline">Meeting</header><text display-inline="yes-display-inline">The Secretary—</text>
<clause commented="no" display-inline="no-display-inline" id="H0EBC60C00F7D428F80B24EF3A67874BA"><enum>(i)</enum><text display-inline="yes-display-inline">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);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H358A1C2DFA894A4F962D51EA34ECFB4B"><enum>(ii)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H4310E174AEB645629990ED38AA2B3971"><enum>(iii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H73E9A9C3D4F641BC93BD82AEC88E1D38"><enum>(3)</enum><header display-inline="yes-display-inline">Agreed initial pediatric study
plan</header><text display-inline="yes-display-inline">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 <quote>Agreed Initial Pediatric Study
Plan</quote>, 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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9F7FB6FE4E164BAEA17B2EB9303A317C"><enum>(4)</enum><header display-inline="yes-display-inline">Deferral and waiver</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H06186D244DB24A03AB502980BBD8EF64"><enum>(5)</enum><header display-inline="yes-display-inline">Amendments to the plan</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5F8A4CEEAC67449C8C5AFD732D9DF1D7"><enum>(6)</enum><header display-inline="yes-display-inline">Internal committee</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDE0C7BF8C9E84E6D819FAFA48EAF9D1C"><enum>(7)</enum><header display-inline="yes-display-inline">Required rulemaking</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of the <short-title>Food and Drug Administration
Safety and Innovation Act</short-title>, the Secretary shall promulgate
proposed regulations and issue guidance to implement the provisions of this
subsection.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HBC26D01D30F94DBE9DEC9A3B0133EEC0"><enum>(b)</enum><header display-inline="yes-display-inline">Conforming amendments</header><text display-inline="yes-display-inline">Section 505B (21 U.S.C. 355c) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HD4C3EC0349354638B412A7996F83F835"><enum>(1)</enum><text display-inline="yes-display-inline">by amending subclause (II) of subsection
(a)(3)(A)(ii) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HB1DA2B5F99E544D08C38393341CDE624" style="OLC">
<subclause commented="no" display-inline="no-display-inline" id="HFCA71ECE5CC8456BB5CA09C563ECDA9C"><enum>(II)</enum><text display-inline="yes-display-inline">a pediatric study plan as described in
subsection (e);</text>
</subclause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF176F0F961A14A21BD37DA235249B3EA"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (f)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H1DE1D619F2A54613AB6B9A385B732414"><enum>(A)</enum><text display-inline="yes-display-inline">in the subsection heading, by striking
<quote><header-in-text level="subsection" style="OLC">pediatric
plans,</header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC">pediatric study
plans,</header-in-text></quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H43DF690E708C41189EC91EC4EC158DF8"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>all
pediatric plans</quote> and inserting <quote>initial pediatric study plans,
agreed initial pediatric study plans,</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBA63CC1912DF436690CE27369FA4FFE4"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text>
<clause commented="no" display-inline="no-display-inline" id="H21BBB009FF194C429354B9158DA55814"><enum>(i)</enum><text display-inline="yes-display-inline">in the paragraph heading, by striking
<quote><header-in-text level="subsection" style="OLC">pediatric
plans,</header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC">pediatric study plans,</header-in-text></quote>;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H2220291A7B0D48C483C66EFDE9AE58F2"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>pediatric plans</quote>
and inserting <quote>initial pediatric study plans, agreed initial pediatric
study plans,</quote>.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H817DEAED0560497594E3DB8FEF81C66C"><enum>(c)</enum><header display-inline="yes-display-inline">Effective date</header>
<paragraph commented="no" display-inline="no-display-inline" id="H86FCD4CC79124BD08F98FEFAD4EE4A4B"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE22F5CFB5E2A4ED489D43D648A07CAA4"><enum>(2)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="HC4D9D9F472DA405EA777A5F7D015DAE9" section-type="subsequent-section"><enum>507.</enum><header display-inline="yes-display-inline">Reauthorizations</header>
<subsection commented="no" display-inline="no-display-inline" id="H96D3981730054422A18152EC447DF9DA"><enum>(a)</enum><header display-inline="yes-display-inline">Pediatric Advisory Committee</header><text display-inline="yes-display-inline">Section 14(d) of the Best Pharmaceuticals
for Children Act (42 U.S.C. 284m note) is amended by striking <quote>during the
five-year period beginning on the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007</quote> and inserting <quote>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))</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H94E66E5A2FD9437F93FC769F9012BD38"><enum>(b)</enum><header display-inline="yes-display-inline">Pediatric Subcommittee of the Oncologic
Drugs Advisory Committee</header><text display-inline="yes-display-inline">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 <quote>during the five-year period beginning on
the date of the enactment of the Best Pharmaceuticals for Children Act of
2007</quote> and inserting <quote>for the duration of the operation of the
Oncologic Drugs Advisory Committee</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HB19E476AE8D047D5A3A255624346A2BA"><enum>(c)</enum><header display-inline="yes-display-inline">Humanitarian device exemption
extension</header><text display-inline="yes-display-inline">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 <quote>2012</quote> and inserting
<quote>2017</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H033488C2FD1A4906A5B8144F710504E7"><enum>(d)</enum><header display-inline="yes-display-inline">Program for pediatric study of drugs in
PHSA</header><text display-inline="yes-display-inline">Section 409I(e)(1) of
the Public Health Service Act (42 U.S.C. 284m(e)(1)) is amended by striking
<quote>to carry out this section</quote> and all that follows through the end
of paragraph (1) and inserting <quote>to carry out this section, $25,000,000
for each of fiscal years 2013 through 2017.</quote>.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H1E0FB81EE797452A8487D182536F1426" section-type="subsequent-section"><enum>508.</enum><header display-inline="yes-display-inline">Report</header>
<subsection commented="no" display-inline="no-display-inline" id="H17E0D66BE4F04D64A6BBBECA3714DED7"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HD630D315BFA0444AA6EAABCEFE2A9A98"><enum>(b)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">Each report under subsection (a) shall
include—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H3F452B02DE0B4FDC88B279C00A546EBB"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD7D1BF973FD140F083526E5958869759"><enum>(2)</enum><text display-inline="yes-display-inline">the number of required studies under such
section 505B that have not met the initial deadline provided under such section
505B, including—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H8D3D0CBA1A3B4088BB40FD327A8C5900"><enum>(A)</enum><text display-inline="yes-display-inline">the number of deferrals and deferral
extensions granted and the reasons such extensions were granted;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7D54A377750C4E95BBB42B4A2732B325"><enum>(B)</enum><text display-inline="yes-display-inline">the number of waivers and partial waivers
granted; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4631DE2314994BF1B5EBA9C360C98A06"><enum>(C)</enum><text display-inline="yes-display-inline">the number of letters issued under
subsection (d) of such section 505B;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC9B50E122B194AD4B3926A481D6C1C83"><enum>(3)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2642A275F98D4E7FB1521540ED98CD2F"><enum>(4)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5FC895D459724846B9CB063BC24E1C2A"><enum>(5)</enum><text display-inline="yes-display-inline">a description and current status of
referrals made under subsection (n) of such section 505A;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H089763BA56944520A180F247FC191DD8"><enum>(6)</enum><text display-inline="yes-display-inline">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);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H494D323E57E64C71819B25FABDF02A00"><enum>(7)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HD8E88D5FA8154A4ABDDEBDE7FBC808A6"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0F6587A970CC42D89D9496C0A9B72AD8" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">the results of such efforts;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDEFEDC8B6D4B47D0A1CA877C020A5074"><enum>(8)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H8AEDAB9D96C24132AF53C109B66D0BB3"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H89388522B7CD4D1AAE88E7F71312ED49" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H19E61700982B47C0B675EE40BD07906C"><enum>(9)</enum><text display-inline="yes-display-inline">any recommendations for modification to
such programs that would improve pediatric drug research and increase pediatric
labeling of drugs and biological products;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7CF6FD9912B1459FA577E119E4BD833C"><enum>(10)</enum><text display-inline="yes-display-inline">an assessment of the successes of and
limitations to studying drugs for rare diseases under such sections 505A and
505B; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9AB0E47958CB45CABAECDD369A97528A"><enum>(11)</enum><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H8FA14F7383B948AF9A4F7F9AF1A225BF"><enum>(A)</enum><text display-inline="yes-display-inline">improving public access to information from
pediatric studies conducted under such sections 505A and 505B; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA2320F7799EE41A39D5A4A22E837C170"><enum>(B)</enum><text display-inline="yes-display-inline">improving the timeliness of pediatric
studies and pediatric study planning under such sections 505A and 505B.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HC9A0B82CD7DA4070B44D7415F657EFFA"><enum>(c)</enum><header display-inline="yes-display-inline">Stakeholder comment</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H4F0A1D887C884DFF8443F89B987CE767" section-type="subsequent-section"><enum>509.</enum><header display-inline="yes-display-inline">Technical amendments</header>
<subsection commented="no" display-inline="no-display-inline" id="H2DE6A8E1DDDF4782B85AD3D7C2EDB2A1"><enum>(a)</enum><header display-inline="yes-display-inline">Pediatric studies of drugs in
FFDCA</header><text display-inline="yes-display-inline">Section 505A (21 U.S.C.
355a) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H4E700125FF5944F997D1540748181ADB"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (k)(2), by striking
<quote>subsection (f)(3)(F)</quote> and inserting <quote>subsection
(f)(6)(F)</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBAAA8A611FC9418E820184200C7BB631"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (l)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H6BE1E48275BD4E4FAB4B1F11F92B62A5"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<clause commented="no" display-inline="no-display-inline" id="HC9E93DC78D194AB38B25C14D143CEED1"><enum>(i)</enum><text display-inline="yes-display-inline">in the paragraph heading, by striking
<quote><header-in-text level="paragraph" style="OLC">year
one</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">first 18-month period</header-in-text></quote>;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H3D5A839C70FD419EAE89012BBC9A9D15"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>one-year</quote> and
inserting <quote>18-month</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H79F47EDB6148458F92CDF513EBFB2470"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<clause commented="no" display-inline="no-display-inline" id="HB74947F0EF744516AA7AE8DEECFD63B2"><enum>(i)</enum><text display-inline="yes-display-inline">in the paragraph heading, by striking
<quote><header-in-text level="paragraph" style="OLC">years</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">periods</header-in-text></quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HEA34DC83312B4AB99976AE4BF30011E1"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>one-year period</quote>
and inserting <quote>18-month period</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5D656BE4C0F24B4D8DD7200B5D3EA0C8"><enum>(C)</enum><text display-inline="yes-display-inline">by redesignating paragraph (3) as paragraph
(4); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H228E7BD5CDE84649B094F5B44C759A61"><enum>(D)</enum><text display-inline="yes-display-inline">by inserting after paragraph (2) the
following:</text>
<quoted-block display-inline="no-display-inline" id="HA7DAAA20B70340B4A03E2CC41929D5CC" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="HEEC8166881394B17AE97D8F2F2905913"><enum>(3)</enum><header display-inline="yes-display-inline">Preservation of authority</header><text display-inline="yes-display-inline">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.</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD7AA336A9FAA4069B6CD3EB059130EF0"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (n)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H0A9A0FB079244777952696B131F1E769"><enum>(A)</enum><text display-inline="yes-display-inline">in the subsection heading, by striking
<quote><header-in-text level="subsection" style="OLC">completed</header-in-text></quote> and inserting
<quote><header-in-text level="subsection" style="OLC">submitted</header-in-text></quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HFEA904C4652F4A099007228D94770F9C"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<clause commented="no" display-inline="no-display-inline" id="HA5676EF063714D088A77BE1ADA752291"><enum>(i)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph (A),
by striking <quote>have not been completed</quote> and inserting <quote>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</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H97F9219A3AD84BBBBAF38BA09E7C1C1C"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text>
<subclause commented="no" display-inline="no-display-inline" id="H8F8DA7097427447099FB890E372E903C"><enum>(I)</enum><text display-inline="yes-display-inline">in the first sentence, by inserting
<quote>, 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</quote>
after <quote>expired</quote>; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H4691CF5D8FF148E19E6C2E0A3B69FACC"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>Prior to</quote> and all
that follows through the period at the end; and</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="HCA46663595C2400C8547BE367B027365"><enum>(iii)</enum><text display-inline="yes-display-inline">in subparagraph (B), by striking <quote>no
listed patents or has 1 or more listed patents that have expired,</quote> and
inserting <quote>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,</quote>; and</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H15E2BB4C2F1B440995A01AEFC28AC211"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (o)(2), by amending
subparagraph (B) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HCA1673D4B26342CE9D3530A9FDD21E1C" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H5CD82E0383334BE4947C67A49745F05B"><enum>(B)</enum><text display-inline="yes-display-inline">a statement of any appropriate pediatric
contraindications, warnings, precautions, or other information that the
Secretary considers necessary to assure safe
use.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H74AAB44D4A2D47479A2DAB09D495A779"><enum>(b)</enum><header display-inline="yes-display-inline">Research into pediatric uses for drugs and
biological projects in FFDCA</header><text display-inline="yes-display-inline">Section 505B (21 U.S.C. 355c) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H24E8639B6F2B45539E6158B8AE9A3B3A"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H59E95200DA2A48BC815457DD7A7869CE"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), in the matter before
subparagraph (A), by inserting <quote>for a drug</quote> after <quote>(or
supplement to an application)</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HFC558E679FD141E7B7390A1A094F3CE6"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (4)(C)—</text>
<clause commented="no" display-inline="no-display-inline" id="H48271D65122B4ECD8E557D388454AE66"><enum>(i)</enum><text display-inline="yes-display-inline">in the first sentence, by inserting
<quote>partial</quote> before <quote>waiver is granted</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H14E9F4C4DC954F6FA2C75040FCECEA8F"><enum>(ii)</enum><text display-inline="yes-display-inline">in the second sentence, by striking
<quote>either a full or</quote> and inserting <quote>such a</quote>;</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0BBF1757F1814E828A3DF9C2C33FBC89"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)(1), in the matter
preceding subparagraph (A), by striking <quote>After providing notice</quote>
and all that follows through <quote>studies), the</quote> and inserting
<quote>The</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4C5D902191064DD49298E65DF2833380"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (g)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H14026FAF85EB438C90B2E60B636FD7FF"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)(A), by inserting
<quote>that receives a priority review or 330 days after the date of the
submission of an application or supplement that receives a standard
review</quote> after <quote>after the date of the submission of the application
or supplement</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB21895E4968C481DB090AAA793716647"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2), by striking <quote>the
label of such product</quote> and inserting <quote>the labeling of such
product</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDCECF32C8D424741998D18935E434F16"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (h)(1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HA79CB3E6CDC94AC1B01DC21AF96FF083"><enum>(A)</enum><text display-inline="yes-display-inline">by inserting <quote>an application (or
supplement to an application) that contains</quote> after <quote>date of
submission of</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8AD4ADE54C5A46BDAB4B3F7CFA714BD7"><enum>(B)</enum><text display-inline="yes-display-inline">by inserting <quote>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,</quote> after <quote>under this
section,</quote>; and</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB0EB16640435442BA85ACC08257B6DC3"><enum>(5)</enum><text display-inline="yes-display-inline">in subsection (i)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HA2A95EF69B2E4831B71CCFFAF5CD02CA"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<clause commented="no" display-inline="no-display-inline" id="H30F46BFDB7D24502830A94BCF9C63108"><enum>(i)</enum><text display-inline="yes-display-inline">in the paragraph heading, by striking
<quote><header-in-text level="paragraph" style="OLC">year
one</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">first 18-month period</header-in-text></quote>;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H0EEB016B51C940A0841FD88976F560AA"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>one-year</quote> and
inserting <quote>18-month</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3C3824E3885648A484D23EC7E8D3E834"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<clause commented="no" display-inline="no-display-inline" id="H32D9271F0C3B4ACC99F3E9158CEAF1F6"><enum>(i)</enum><text display-inline="yes-display-inline">in the paragraph heading, by striking
<quote><header-in-text level="paragraph" style="OLC">years</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">periods</header-in-text></quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HFAF95BA5881C4E769E8D937E89EFE162"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>one-year period</quote>
and inserting <quote>18-month period</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H29E0DD06B7F440839958F893601F7B5F"><enum>(C)</enum><text display-inline="yes-display-inline">by redesignating paragraph (3) as paragraph
(4); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB17FCDAB290D4BFAB0A8C04306B18E08"><enum>(D)</enum><text display-inline="yes-display-inline">by inserting after paragraph (2) the
following:</text>
<quoted-block display-inline="no-display-inline" id="H0AD1E8BC7EF24F229AF5A00DECA276EF" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H325F9DC8AE354BFEB8DD40DBF8066B6D"><enum>(3)</enum><header display-inline="yes-display-inline">Preservation of authority</header><text display-inline="yes-display-inline">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.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H3597B41A35734E239F6F3F5BDAB19F20"><enum>(c)</enum><header display-inline="yes-display-inline">Internal Committee for Review of Pediatric
Plans, Assessments, Deferrals, Deferral Extensions, and Waivers</header><text display-inline="yes-display-inline">Section 505C (21 U.S.C. 355d) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H90BAFA85974047E5A8B6EE7C28C38188"><enum>(1)</enum><text display-inline="yes-display-inline">in the section heading, by inserting
<quote><header-in-text level="section" style="OLC">deferral
extensions,</header-in-text></quote> after <quote><header-in-text level="section" style="OLC">deferrals,</header-in-text></quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H08E560EBAA70489E9A236F38A989ADA5"><enum>(2)</enum><text display-inline="yes-display-inline">by inserting <quote>neonatology,</quote>
after <quote>pediatric ethics,</quote>.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H288DEBC30420415DAEC1ECE0E8404B79"><enum>(d)</enum><header display-inline="yes-display-inline">Program for pediatric studies of
drugs</header><text display-inline="yes-display-inline">Section 409I(c) of the
Public Health Service Act (42 U.S.C. 284m(c)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H3B91F67F76D54FA68347E5BAA81BD0A8"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H3E91C45CC86B4468AC91039543869EC6"><enum>(A)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph (A),
by inserting <quote>or section 351(m) of this Act,</quote> after
<quote>Cosmetic Act,</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H933C7949930541DA8289A9303C3F54BC"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (A)(i), by inserting
<quote>or section 351(k) of this Act</quote> after <quote>Cosmetic Act</quote>;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HFA96C9AB692A4BABA4D36395A7BD4D59"><enum>(C)</enum><text display-inline="yes-display-inline">by amending subparagraph (B) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="HBCE339E144AC432B938C6E72B764EDF3" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H7E36E3FD8F944B469E8203176CF145B9"><enum>(B)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H33268E475966410AA5D6D83C65789E8C"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HEA1D10BAB0E942D09ADE6E6B1F3E222D"><enum>(A)</enum><text display-inline="yes-display-inline">in the paragraph heading, by striking
<quote><header-in-text level="paragraph" style="OLC">for drugs lacking
exclusivity</header-in-text></quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC631EC37C64149C788680E281D2C6B63"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>under section 505 of the
Federal Food, Drug, and Cosmetic Act</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H10CE3ED3C1E545499B6AF875B887BF96"><enum>(C)</enum><text display-inline="yes-display-inline">by striking <quote>505A of such Act</quote>
and inserting <quote>505A of the Federal Food, Drug, and Cosmetic Act or
section 351(m) of this Act</quote>.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HA06E02ED3F6043A18737DB21555A8419"><enum>(e)</enum><header display-inline="yes-display-inline">Pediatric subcommittee of the Oncologic
Advisory Committee</header><text display-inline="yes-display-inline">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 <quote>section 505C</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H50D055591E9148B9939C589DCC76B6FA"><enum>(f)</enum><header display-inline="yes-display-inline">Foundation of national institutes of
health</header><text display-inline="yes-display-inline">Section 499(c)(1)(C)
of the Public Health Service Act (42 U.S.C. 290b(c)(1)(C)) is amended by
striking <quote>for which the Secretary issues a certification in the
affirmative under section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic
Act</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HCF735DB51C9545DE84EFD72564628811"><enum>(g)</enum><header display-inline="yes-display-inline">Application; transition rule</header>
<paragraph commented="no" display-inline="no-display-inline" id="H4E9337266FC1406393298CFE7410643C"><enum>(1)</enum><header display-inline="yes-display-inline">Application</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1BA97F2631C74CBBA423449C290A11D5"><enum>(2)</enum><header display-inline="yes-display-inline">Transitional rule for adverse event
reporting</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H97703EC91E224FF3A53D567FF19EB2E2" section-type="subsequent-section"><enum>510.</enum><header display-inline="yes-display-inline">Pediatric rare diseases</header>
<subsection commented="no" display-inline="no-display-inline" id="HA63FC22710DC4470B77E56445A5F5F2B"><enum>(a)</enum><header display-inline="yes-display-inline">Public
meeting</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HA483C0230EDF498B8DD81CD88620CFF8"><enum>(b)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HB7EA5EC162864456B0E960886CAC17CF" section-type="subsequent-section"><enum>511.</enum><header display-inline="yes-display-inline">Staff of Office of Pediatric
Therapeutics</header><text display-inline="no-display-inline">Section 6 of the
Best Pharmaceuticals for Children Act (21 U.S.C. 393a) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H0C090A6304D34FA388E48883A84B6593"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (c)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HCDA7212701944B7587F81A6E809B6F3E"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking
<quote>and</quote> at the end;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H467410FC0AD94F909A016664FD05985B"><enum>(B)</enum><text display-inline="yes-display-inline">by redesignating paragraph (2) as paragraph
(4); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8084BF9C75D64965B198756E153AFEC4"><enum>(C)</enum><text display-inline="yes-display-inline">by inserting after paragraph (1) the
following:</text>
<quoted-block display-inline="no-display-inline" id="H825C1834D60B45A594E01EE981CF3ED2" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H2AFE38739AEC47D5AB7B706E1A0665BC"><enum>(2)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H72B59308760545FD9E95F5090827AEF3"><enum>(3)</enum><text display-inline="yes-display-inline">one or more additional individuals with
expertise in pediatric epidemiology;
and</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H01919E1FBBCB4B7097D23944E3A72CE6"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H327F16B16BBD4905A460103CC16EC8CE" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H8B3F42F3B86547D88C6486CA8599868B"><enum>(d)</enum><header display-inline="yes-display-inline">Neonatology expertise</header><text display-inline="yes-display-inline">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.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><enum>VI</enum><header display-inline="yes-display-inline">Medical device regulatory
improvements</header>
<section commented="no" display-inline="no-display-inline" id="H447318649E2B4DBE8370034DE623AF49" section-type="subsequent-section"><enum>601.</enum><header display-inline="yes-display-inline">Investigational device
exemptions</header><text display-inline="no-display-inline">Section 520(g) (21
U.S.C. 360j(g)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H3C77CDDEB9544DE4BB397307DAC765D1"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (2)(B)(ii), by inserting
<quote>safety or effectiveness</quote> before <quote>data obtained</quote>;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB2575174B03B435C9539EAB10D33D023"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (4), by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="HD2A9AE0B9A7440449C0B4B1FD8534497" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H13F955A6A4D949B1874F952EE3749F16" indent="up2"><enum>(C)</enum><text display-inline="yes-display-inline">Consistent with paragraph (1), the
Secretary shall not disapprove an application under this subsection because the
Secretary determines that—</text>
<clause commented="no" display-inline="no-display-inline" id="H0FD594C40E8144A0A354963CF50C1172"><enum>(i)</enum><text display-inline="yes-display-inline">the investigation may not support a
substantial equivalence or de novo classification determination or approval of
the device;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H570617D66107472B89C93B5189A4D6C3"><enum>(ii)</enum><text display-inline="yes-display-inline">the investigation may not meet a
requirement, including a data requirement, relating to the approval or
clearance of a device; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HF838DF3E1E2443A7B5ADC025854AF79F"><enum>(iii)</enum><text display-inline="yes-display-inline">an additional or different investigation
may be necessary to support clearance or approval of the
device.</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H28E52EBC4EB3494FB4A64A3BF6A05C95" section-type="subsequent-section"><enum>602.</enum><header display-inline="yes-display-inline">Clarification of least burdensome
standard</header>
<subsection commented="no" display-inline="no-display-inline" id="HD883F0C44F5349F8A282BD73D077209F"><enum>(a)</enum><header display-inline="yes-display-inline">Premarket approval</header><text display-inline="yes-display-inline">Section 513(a)(3)(D) (21 U.S.C.
360c(a)(3)(D)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H68BCA67E71D34EF490F7CBABE4B2362F"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating clause (iii) as clause
(v); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H291A774E732147C786A59C270356098D"><enum>(2)</enum><text display-inline="yes-display-inline">by inserting after clause (ii) the
following:</text>
<quoted-block display-inline="no-display-inline" id="HFAD4EB95CC2B45AC92361C8A4E564ECE" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="H413E8483FB4249E08A944E48AB65D161" indent="up3"><enum>(iii)</enum><text display-inline="yes-display-inline">For purposes of clause (ii), the term
<term>necessary</term> 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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H2278E6C4A4A34267AC9B69ED45442D0A" indent="up3"><enum>(iv)</enum><text display-inline="yes-display-inline">Nothing in this subparagraph shall alter
the criteria for evaluating an application for premarket approval of a
device.</text>
</clause><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HFB2B6BB68B294208B9709EB667BF84F1"><enum>(b)</enum><header display-inline="yes-display-inline">Premarket notification under section
510<enum-in-header>(k)</enum-in-header></header><text display-inline="yes-display-inline">Section 513(i)(1)(D) (21 U.S.C.
360c(i)(1)(D)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H756E8A311EF446B09F7E04A10E0E6ADF"><enum>(1)</enum><text display-inline="yes-display-inline">by striking ‘‘(D) Whenever’’ and inserting
‘‘(D)(i) Whenever’’; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H21DB8AC0574E4EF4A230D72AF5018BC3"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H047394945BA64002B245A0AACF5A9DAD" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="H8F9768145F864DD5B5F426D9295A0051" indent="up3"><enum>(ii)</enum><text display-inline="yes-display-inline">For purposes of clause (i), the term
<term>necessary</term> means the minimum required information that would
support a determination of substantial equivalence between a new device and a
predicate device.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HF45636EE9B6F4B3F8DF5AEEB87A02457" indent="up3"><enum>(iii)</enum><text display-inline="yes-display-inline">Nothing in this subparagraph shall alter
the standard for determining substantial equivalence between a new device and a
predicate
device.</text>
</clause><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H3722EBC173044A579B221A8C26509676" section-type="subsequent-section"><enum>603.</enum><header display-inline="yes-display-inline">Agency documentation and review of
significant decisions</header><text display-inline="no-display-inline">Chapter
V is amended by inserting after section 517 (21 U.S.C. 360g) the
following:</text>
<quoted-block display-inline="no-display-inline" id="HADA869ED208A446D87B8886C9C1613A4" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H0C0C40C3475C43B0991A74323EF0D3D1" section-type="subsequent-section"><enum>517A.</enum><header display-inline="yes-display-inline">Agency documentation and review of
significant decisions regarding devices</header>
<subsection commented="no" display-inline="no-display-inline" id="HC82B31A6200C40A3B621591ED40BBCCD"><enum>(a)</enum><header display-inline="yes-display-inline">Documentation of rationale for significant
decisions</header>
<paragraph commented="no" display-inline="no-display-inline" id="HDAB9EFFE6C7E46D5B04D6DF6705D3093"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1E8FB713BAA243CEA213D32DA329C3D2"><enum>(2)</enum><header display-inline="yes-display-inline">Provision of documentation</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H84CB31DADE00433D85C053F2AE25BDD6"><enum>(b)</enum><header display-inline="yes-display-inline">Review of significant decisions</header>
<paragraph commented="no" display-inline="no-display-inline" id="H01F809D38BE545BC9C5B971482E20211"><enum>(1)</enum><header display-inline="yes-display-inline">Request for supervisory review of
significant decision</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H19F7F389870F464584D3A32DD72CB7A8"><enum>(2)</enum><header display-inline="yes-display-inline">Submission of request</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H540CCE8AE87D4E4E919A478180CDE63D"><enum>(3)</enum><header display-inline="yes-display-inline">Timeframe</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H06A52A317DFD42C085A2385D5B743AAB"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB5640B75D3C046D48E52E0CCAFCD4D3F"><enum>(B)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">Subparagraph (A) shall not apply in cases
that are referred to experts outside of the Food and Drug
Administration.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="HFCC68958A77541C2915357F00295FCBD" section-type="subsequent-section"><enum>604.</enum><header display-inline="yes-display-inline">Device modifications requiring premarket
notification prior to marketing</header><text display-inline="no-display-inline">Section 510(n) (21 U.S.C. 360(n)) is amended
by—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HD1E87A2DD4954FA48F72D6F472D0CABC"><enum>(1)</enum><text display-inline="yes-display-inline">striking <quote>(n) The Secretary</quote>
and inserting <quote>(n)(1) The Secretary</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H97A9A97CBA884617BF27E2CB70CE1611"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H64915E33DE1442F998EE8A0366FF10AA" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="HD90E95D6A200472FB61E0978747DD496"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HEF27FCD823574FC2AD954A22C02EB025"><enum>(A)</enum><text display-inline="yes-display-inline">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: <quote>could
significantly affect the safety or effectiveness of the device</quote>,
<quote>a significant change or modification in design, material, chemical
composition, energy source, or manufacturing process</quote>, and <quote>major
change or modification in the intended use of the device</quote>. 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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HFFCCE9018C9A4ED2BD93820A399EEDF7" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">The Secretary shall withdraw the Food and
Drug Administration draft guidance entitled <quote>Guidance for Industry and
FDA Staff—510(k) Device Modifications: Deciding When to Submit a 510(k) for a
Change to an Existing Device</quote>, 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—</text>
<clause commented="no" display-inline="no-display-inline" id="HD1E4128265D34AC396A38DFE8C865681"><enum>(i)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H2AD58B98448E4EAABE2E6DFD6CB4A2D9"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF2BEE7FC59CF4D5DA8FE5616A7136D44" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">The Food and Drug Administration guidance
entitled <quote>Deciding When to Submit a 510(k) for a Change to an Existing
Device</quote>, 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.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H6880238A2AE546E18544460BFA3A394C" section-type="subsequent-section"><enum>605.</enum><header display-inline="yes-display-inline">Program to improve the device recall
system</header><text display-inline="no-display-inline">Chapter V is amended by
inserting after section 518 (21 U.S.C. 360h) the following:</text>
<quoted-block display-inline="no-display-inline" id="HE76E82DF0F0A40B69CAB24D834C98B4B" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H909B837F9E694DA082103B2109BADC03" section-type="subsequent-section"><enum>518A.</enum><header display-inline="yes-display-inline">Program to improve the device recall
system</header>
<subsection commented="no" display-inline="no-display-inline" id="H47270F462D784FB293D430EEFA448C2B"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HFA48E05133684FBDB7C7FF0D186AA00F"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFA1A220D1D524922BA522A227099A623"><enum>(2)</enum><text display-inline="yes-display-inline">clarify procedures for conducting device
recall audit checks to improve the ability of investigators to perform those
checks in a consistent manner;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HCF605983C9BC49D39FC9558461609A68"><enum>(3)</enum><text display-inline="yes-display-inline">develop detailed criteria for assessing
whether a person performing a device recall has performed an effective
correction or action plan for the recall; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HCC8690E95C254A1D8D3F6A5E86054FEF"><enum>(4)</enum><text display-inline="yes-display-inline">document the basis for each termination by
the Food and Drug Administration of a device recall.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H46A6D1E4B4C04685B1007B29B8EB9D7C"><enum>(b)</enum><header display-inline="yes-display-inline">Assessment content</header><text display-inline="yes-display-inline">The program established under subsection
(a)(1) shall, at a minimum, identify—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H5DC8561A61A84883AF5B3C1503D1F057"><enum>(1)</enum><text display-inline="yes-display-inline">trends in the number and types of device
recalls;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H80E9A833D2994F50BCD127A515A134D2"><enum>(2)</enum><text display-inline="yes-display-inline">devices that are most frequently the
subject of a recall; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0162A3586AAF4DC5AF653A4824F4801A"><enum>(3)</enum><text display-inline="yes-display-inline">underlying causes of device recalls.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H30FC55ECD64544489FC231B0F0E3C83E"><enum>(c)</enum><header display-inline="yes-display-inline">Termination of recalls</header><text display-inline="yes-display-inline">The Secretary shall document the basis for
the termination by the Food and Drug Administration of a device recall.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H3C3BC3C0647D4BE89DF5D904C2E7A4C9"><enum>(d)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">In this section, the term
<term>recall</term> means—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HE6C7609540304EF991F1899B21E996E0"><enum>(1)</enum><text display-inline="yes-display-inline">the removal from the market of a device
pursuant to an order of the Secretary under subsection (b) or (e) of section
518; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB9232546612841E18B5C70C7782804E8"><enum>(2)</enum><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H335D1856BBBD44D2967FE41A3D894D45" section-type="subsequent-section"><enum>606.</enum><header display-inline="yes-display-inline">Clinical holds on investigational device
exemptions</header><text display-inline="no-display-inline">Section 520(g) (21
U.S.C. 360j(g)) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H476C95BAD39F4F70AE13F31903CA4ECD" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H3310C1729A404C10A40177B1ABF29684" indent="up1"><enum>(8)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H1136C8D648C34076B6D64940E8199779"><enum>(A)</enum><text display-inline="yes-display-inline">At any time, the Secretary may prohibit the
sponsor of an investigation from conducting the investigation (referred to in
this paragraph as a <quote>clinical hold</quote>) 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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD535E581A96D48F7A8C992F38401A3A9" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">For purposes of subparagraph (A), a
determination described in this subparagraph with respect to a clinical hold is
a determination that—</text>
<clause commented="no" display-inline="no-display-inline" id="HE737C76DF5B64CB4A0B0A7141E3CA3C2"><enum>(i)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H475A456CE4D04F359F1B44398E71F5EE"><enum>(ii)</enum><text display-inline="yes-display-inline">the clinical hold should be issued for such
other reasons as the Secretary may by regulation establish.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5490715780E949068390822D1AB19349" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H9F7D261632684E928B39CE0BFFE0DCE9" section-type="subsequent-section"><enum>607.</enum><header display-inline="yes-display-inline">Modification of de novo application
process</header>
<subsection commented="no" display-inline="no-display-inline" id="HFCFB8B2A9828475BA6E94C2DA835CC69"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 513(f)(2) (21 U.S.C. 360c(f)(2)) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H183FC72155894C108842C0805A31D9B0"><enum>(1)</enum><text display-inline="yes-display-inline">by inserting <quote>(i)</quote> after
<quote>(2)(A)</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3DB4E8A20838470CA18F687833DD4AF5"><enum>(2)</enum><text display-inline="yes-display-inline">in subparagraph (A)(i), as so designated by
paragraph (1), by striking <quote>under the criteria set forth</quote> and all
that follows through the end of subparagraph (A) and inserting a period;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB94692D0A59B4EEF90AA4165084701A3"><enum>(3)</enum><text display-inline="yes-display-inline">by adding at the end of subparagraph (A)
the following:</text>
<quoted-block display-inline="no-display-inline" id="H9D79401965744E20B3BCB6D6BD0F0BF6" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="H43F60D3078D3406BADD0B82DF8EA337B" indent="up3"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H463EE21EE6A6439D8194D2738078AFB2" indent="up3"><enum>(iii)</enum><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H00C341F611FE47B69A8E70131D5E2C5D" indent="up3"><enum>(iv)</enum><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HF397B0026C8445CBB21F5FEC2D91D531" indent="up3"><enum>(v)</enum><text display-inline="yes-display-inline">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.</text>
</clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H107E77D69EAC42AABBD4A1884589A467"><enum>(4)</enum><text display-inline="yes-display-inline">in subparagraph (B), by striking <quote>Not
later than 60 days after the date of the submission of the request under
subparagraph (A), the Secretary</quote> and inserting <quote>The
Secretary</quote>.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF647CC2BA8FB4933AD368A990A47D2A0"><enum>(b)</enum><header display-inline="yes-display-inline">Conforming amendments</header><text display-inline="yes-display-inline">Section 513(f) (21 U.S.C. 360c(f)) is
amended in paragraph (1)—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HCA2DECFB4BD64E5EBD6B6EA04EB1B099"><enum>(1)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking <quote>,
or</quote> at the end and inserting a semicolon;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1C14319E136D441199E91B2801A88747"><enum>(2)</enum><text display-inline="yes-display-inline">in subparagraph (B), by striking the period
and inserting <quote>; or</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3C18E444A79D4250AB74B65731AFBAFC"><enum>(3)</enum><text display-inline="yes-display-inline">by inserting after subparagraph (B) the
following:</text>
<quoted-block display-inline="no-display-inline" id="HF5910DD75A6E4989895B72E4156E846A" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H49EECB4FC1E7402799E6B700BE704DFE" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">the device is classified pursuant to a
request submitted under paragraph
(2).</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H43C88E204F3C4594A1ACDF68B9C1C7BB" section-type="subsequent-section"><enum>608.</enum><header display-inline="yes-display-inline">Reclassification procedures</header>
<subsection commented="no" display-inline="no-display-inline" id="HF92FBA8BFBF54A3F866BCAD150A273E0"><enum>(a)</enum><header display-inline="yes-display-inline">Classification changes</header>
<paragraph commented="no" display-inline="no-display-inline" id="HD91EC102B968417DB26FE558DCE44E34"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 513(e)(1) (21 U.S.C. 360c(e)(1)) is
amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HEA88BF3E7C3549158E12C8133F9A2A03" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H96DE718FD2864E0E8AC9CCB0B1EDA048"><enum>(e)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H7A4A47BE70E446FD8911902AD6E8071A"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H0B4539D5E0BA4E7F85E503A01920AE26"><enum>(A)</enum><clause commented="no" display-inline="yes-display-inline" id="H3625828ABC33497385FC4937CF0BCB37"><enum>(i)</enum><text display-inline="yes-display-inline">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—</text>
<subclause commented="no" display-inline="no-display-inline" id="HF6DBDC643AA546FE8B4EC3681E6B759F" indent="up3"><enum>(I)</enum><text display-inline="yes-display-inline">the public health benefit of the use of the
device, and the nature and, if known, incidence of the risk of the
device;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HD5D01E30BCF343A79B66F759AE1CB35D" indent="up3"><enum>(II)</enum><text display-inline="yes-display-inline">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</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H35ED5657704946F4ABCB3AEDC67A5534" indent="up3"><enum>(III)</enum><text display-inline="yes-display-inline">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.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="HED67B1A27D8C40F595C340BAEC49CF47" indent="up3"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3AFD5907513B4227944F0073215C407B" indent="up2"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0D6CFEF7339042AEB45DBFF663805337"><enum>(2)</enum><header display-inline="yes-display-inline">Technical and conforming
amendments</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H7591DB96DAF14509A67F712CFDFF1A2D"><enum>(A)</enum><text display-inline="yes-display-inline">Section 513(e)(2) (21 U.S.C. 360c(e)(2)) is
amended by striking <quote>regulation promulgated</quote> and inserting
<quote>an order issued</quote>.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8D71B406CD254B5B87BA0DBA78371E75"><enum>(B)</enum><text display-inline="yes-display-inline">Section 514(a)(1) (21 U.S.C. 360d(a)(1)) is
amended by striking <quote>under a regulation under section 513(e) but such
regulation</quote> and inserting <quote>under an administrative order under
section 513(e) (or a regulation promulgated under such section prior to the
date of enactment of the <short-title>Food and Drug
Administration Safety and Innovation Act</short-title>) but such order (or
regulation)</quote>.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H706F06EB45A043E19995487AD0EF3340"><enum>(C)</enum><text display-inline="yes-display-inline">Section 517(a)(1) (21 U.S.C. 360g(a)(1)) is
amended by striking <quote>or changing the classification of a device to class
I</quote> and inserting <quote>, an administrative order changing the
classification of a device to class I,</quote>.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2C53C22E0BF54E1D8E79D4CD889984E1"><enum>(3)</enum><header display-inline="yes-display-inline">Devices reclassified prior to the date of
enactment of this Act</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HAF93899D3ACF49A2BEAECDD4E71E4F03"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H431D5316B7894617B68FB06454028442"><enum>(B)</enum><header display-inline="yes-display-inline">Applicability of other
provisions</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H2AB35CEEEDB5408BAC82C32C55740EBC"><enum>(b)</enum><header display-inline="yes-display-inline">Devices marketed before May 28,
1976</header>
<paragraph commented="no" display-inline="no-display-inline" id="H80F3332C076E4A11A34A05A37484AD1E"><enum>(1)</enum><header display-inline="yes-display-inline">Premarket approval</header><text display-inline="yes-display-inline">Section 515 (21 U.S.C. 360e) is
amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H0C35E650AEF64A8EB3B9F1C2A07C2FD0"><enum>(A)</enum><text display-inline="yes-display-inline">in subsection (a), by striking
<quote>regulation promulgated under subsection (b)</quote> and inserting
<quote>an order issued under subsection (b) (or a regulation promulgated under
such subsection prior to the date of enactment of the
<short-title>Food and Drug Administration Safety and
Innovation Act</short-title>)</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H89888F130E244BB395EBE6DA999D469A"><enum>(B)</enum><text display-inline="yes-display-inline">in subsection (b)—</text>
<clause commented="no" display-inline="no-display-inline" id="H60EE778D528D4151BDD0B13B37B633EA"><enum>(i)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<subclause commented="no" display-inline="no-display-inline" id="H3F6CE43880074BB7BF4A2D332E08DE3C"><enum>(I)</enum><text display-inline="yes-display-inline">in the heading, by striking
<quote>Regulation</quote> and inserting <quote>Order</quote>; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HC768336044234860A1D44F0442DF0DA6"><enum>(II)</enum><text display-inline="yes-display-inline">in the matter following subparagraph
(B)—</text>
<item commented="no" display-inline="no-display-inline" id="HC2DE23FDB87D40CA8CB62FD0263B9108"><enum>(aa)</enum><text display-inline="yes-display-inline">by striking <quote>by regulation,
promulgated in accordance with this subsection</quote> and inserting <quote>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</quote>; and</text>
</item><item commented="no" display-inline="no-display-inline" id="HAC60147E65CB46D6855E2CAA76DE4038"><enum>(bb)</enum><text display-inline="yes-display-inline">by adding at the end the following:
<quote>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.</quote>;</text>
</item></subclause></clause><clause commented="no" display-inline="no-display-inline" id="H484A8D42A2CD4BB0ABFD39A2B5A9B08A"><enum>(ii)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<subclause commented="no" display-inline="no-display-inline" id="H9D54DC2F76B24674A3B296B88842AE20"><enum>(I)</enum><text display-inline="yes-display-inline">by striking subparagraph (B); and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H87CF8FA87ACB4E2B973A6EF22E472AFD"><enum>(II)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text>
<item commented="no" display-inline="no-display-inline" id="H2923020F37534414861A9181580A7BFF"><enum>(aa)</enum><text display-inline="yes-display-inline">by striking <quote>(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—</quote> and inserting <quote>(2) A
proposed order required under paragraph (1) shall contain—</quote>;</text>
</item><item commented="no" display-inline="no-display-inline" id="HB65D19CDCA8F41FB9E0C71AEC7D51C02"><enum>(bb)</enum><text display-inline="yes-display-inline">by redesignating clauses (i) through (iv)
as subparagraphs (A) through (D), respectively;</text>
</item><item commented="no" display-inline="no-display-inline" id="H40183D62691E482082B3F4A422C4E970"><enum>(cc)</enum><text display-inline="yes-display-inline">in subparagraph (A), as so redesignated, by
striking <quote>regulation</quote> and inserting <quote>order</quote>;
and</text>
</item><item commented="no" display-inline="no-display-inline" id="H3FF6E2FBC14F47409A85C3760379D9E6"><enum>(dd)</enum><text display-inline="yes-display-inline">in subparagraph (C), as so redesignated, by
striking <quote>regulation</quote> and inserting <quote>order</quote>;</text>
</item></subclause></clause><clause commented="no" display-inline="no-display-inline" id="HCBA87A69C2194EACA6391DA92B299D7B"><enum>(iii)</enum><text display-inline="yes-display-inline">in paragraph (3)—</text>
<subclause commented="no" display-inline="no-display-inline" id="H15F3AEEA768F42D1880B6C081399262F"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>proposed
regulation</quote> each place such term appears and inserting <quote>proposed
order</quote>;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H727BE05D4DBF46E69DD7CED0B5841E47"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>paragraph (2) and
after</quote> and inserting <quote>paragraph (2),</quote>;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HA20004A1EA014EB78AC319DC347EE561"><enum>(III)</enum><text display-inline="yes-display-inline">by inserting <quote>and a meeting of a
device classification panel described in section 513(b),</quote> after
<quote>such proposed regulation and findings,</quote>;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HD267DCD100A44F07A09E4F458D4BEEA1"><enum>(IV)</enum><text display-inline="yes-display-inline">by striking <quote>(A) promulgate such
regulation</quote> and inserting <quote>(A) issue an administrative order under
paragraph (1)</quote>;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H2EC7FA85455745CA82B7E2783849DBB5"><enum>(V)</enum><text display-inline="yes-display-inline">by striking <quote>paragraph
(2)(A)(ii)</quote> and inserting <quote>paragraph (2)(B)</quote>; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HB29F55FECD0C4CEB98282EE1FA89C653"><enum>(VI)</enum><text display-inline="yes-display-inline">by striking <quote>promulgation of the
regulation</quote> and inserting <quote>issuance of the administrative
order</quote>; and</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="HC7EB61DAABD249F88F8331ED1033B0B5"><enum>(iv)</enum><text display-inline="yes-display-inline">by striking paragraph (4); and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H218594E1F5C4434E9547AD1FD54A3724"><enum>(C)</enum><text display-inline="yes-display-inline">in subsection (i)—</text>
<clause commented="no" display-inline="no-display-inline" id="H62A961FD208743D5B742D91D160D452E"><enum>(i)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<subclause commented="no" display-inline="no-display-inline" id="HD7DC12F8A5504F54945908B50298CB01"><enum>(I)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph
(A)—</text>
<item commented="no" display-inline="no-display-inline" id="HC2E72C97B5AD42368FDBAC2C43B6FE3D"><enum>(aa)</enum><text display-inline="yes-display-inline">by striking <quote>December 1, 1995</quote>
and inserting <quote>the date that is 2 years after the date of enactment of
the <short-title>Food and Drug Administration Safety and
Innovation Act</short-title></quote>; and</text>
</item><item commented="no" display-inline="no-display-inline" id="H7B543108B23C41938CB376F4DCE54E58"><enum>(bb)</enum><text display-inline="yes-display-inline">by striking <quote>publish a regulation in
the Federal Register</quote> and inserting <quote>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,</quote>;</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="H2ABC8E6EB3BE4B0EB3F96730356D0C56"><enum>(II)</enum><text display-inline="yes-display-inline">in subparagraph (B), by striking
<quote>final regulation has been promulgated under section 515(b)</quote> and
inserting <quote>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 <short-title>Food and Drug Administration
Safety and Innovation Act</short-title>)</quote>;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H371C00F841EE4CF2B74533F6559202C8"><enum>(III)</enum><text display-inline="yes-display-inline">in the matter following subparagraph (B),
by striking <quote>regulation requires</quote> and inserting
<quote>administrative order issued under this paragraph requires</quote>;
and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HA51AD84D4DC946EE90BF585FC51EE153"><enum>(IV)</enum><text display-inline="yes-display-inline">by striking the third and fourth sentences;
and</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H9473DF62491D4466B0E741781030F83D"><enum>(ii)</enum><text display-inline="yes-display-inline">in paragraph (3)—</text>
<subclause commented="no" display-inline="no-display-inline" id="H88F0B3B1CA984D72BCE1FBFB86B90263"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>regulation
requiring</quote> each place such term appears and inserting <quote>order
requiring</quote>; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H656C76A2EA95485385DDE599A5E43418"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>promulgation of a
section 515(b) regulation</quote> and inserting <quote>issuance of an
administrative order under subsection (b)</quote>.</text>
</subclause></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE627D70C040C4694995BC621D1C51C3F"><enum>(2)</enum><header display-inline="yes-display-inline">Technical and conforming
amendments</header><text display-inline="yes-display-inline">Section 501(f) (21
U.S.C. 351(f)) is amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H67D2E7BE3ED04277998A6A0AF3BB95F9"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (1)(A)—</text>
<clause commented="no" display-inline="no-display-inline" id="H6E5F95C29E8D4A55BDE3CF75CE7B2907"><enum>(i)</enum><text display-inline="yes-display-inline">in subclause (i), by striking <quote>a
regulation promulgated</quote> and inserting <quote>an order issued</quote>;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HD90A125F979E410C98D26B5623B7592D"><enum>(ii)</enum><text display-inline="yes-display-inline">in subclause (ii), by striking
<quote>promulgation of such regulation</quote> and inserting <quote>issuance of
such order</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H48E5F784C814476681E3EC111C08D717"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (2)(B)—</text>
<clause commented="no" display-inline="no-display-inline" id="H5D9AC75FBACE4D898E537C6A7B29DD93"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>a regulation
promulgated</quote> and inserting <quote>an order issued</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H8CCECE09534F4AA496287F553583BCBE"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>promulgation of such
regulation</quote> and inserting <quote>issuance of such order</quote>;
and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H29C415B6CF8A43709FB2BF9F6390AEEB"><enum>(C)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HFAF79DCB23A047908116BF5BD4E3F029" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H4891483277854FDAB0CA4360365206EB" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">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 <short-title>Food and Drug Administration
Safety and Innovation Act</short-title>, a reference in this subsection to an
order issued under section 515(b) shall be deemed to include such
regulation.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC02A384E8DC24EC2B2156031630B5679"><enum>(3)</enum><header display-inline="yes-display-inline">Approval by regulation prior to the date of
enactment of this Act</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HC9062008142B4AEE81669F04BD46A448"><enum>(c)</enum><header display-inline="yes-display-inline">Reporting</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services
shall annually post on the Internet Web site of the Food and Drug
Administration—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HFF2D26B93513441DBA76509BD0C53E59"><enum>(1)</enum><text display-inline="yes-display-inline">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));</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H8F51B8DB50E44E889C01EA6F4F2A3DA0"><enum>(2)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF3B589F52C84484C84BD0155AF0DFC3F"><enum>(3)</enum><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="HC2D142B08A304217B1A9697B68CD2771" section-type="subsequent-section"><enum>609.</enum><header display-inline="yes-display-inline">Harmonization of device premarket review,
inspection, and labeling symbols</header><text display-inline="no-display-inline">Paragraph (4) of section 803(c) (21 U.S.C.
383(c)) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H32D6E9DC4B2844479C0816C111AEE23D" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="HB430911E769C4CCDB913AC76E35A2BDC" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph><after-quoted-block>.
</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H1772342120F2457B95AC031476CE6B69" section-type="subsequent-section"><enum>610.</enum><header display-inline="yes-display-inline">Participation in international
fora</header><text display-inline="no-display-inline">Paragraph (3) of section
803(c) (21 U.S.C. 383(c)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H89ACE42ABA2F4CDBB314520E539DD54E"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>(3)</quote> and
inserting <quote>(3)(A)</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7211C0E62F14447BAFA8219F491A06E6"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HDE2AD41B92F0480BB80875CF0E5606EE" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H74DE725BCC5B4BC1B075399017EA0EA5" indent="up2"><enum>(B)</enum><text display-inline="yes-display-inline">In carrying out subparagraph (A), the
Secretary may participate in appropriate fora, including the International
Medical Device Regulators Forum, and may—</text>
<clause commented="no" display-inline="no-display-inline" id="H7F28CBD756E74BE6B92BBF2759177E4B"><enum>(i)</enum><text display-inline="yes-display-inline">provide guidance to such fora on
strategies, policies, directions, membership, and other activities of a forum
as appropriate;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HB452AA4EA439470F89D82F29EC94A052"><enum>(ii)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H9E36E8CD96064AD08AA0BBC5254AA79F"><enum>(iii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="HCBE6A91C58224E9B97C150C52BA37298" section-type="subsequent-section"><enum>611.</enum><header display-inline="yes-display-inline">Reauthorization of third-party
review</header>
<subsection commented="no" display-inline="no-display-inline" id="H4366509C0B594E639979102DBBF550F4"><enum>(a)</enum><header display-inline="yes-display-inline">Periodic reaccreditation</header><text display-inline="yes-display-inline">Section 523(b)(2) (21 U.S.C. 360m(b)(2)) is
amended by adding at the end of the following:</text>
<quoted-block display-inline="no-display-inline" id="H519241B3FA8949C09C994FCEE0467849" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H4FE716B328B149208A48611A75798683"><enum>(E)</enum><header display-inline="yes-display-inline">Periodic reaccreditation</header>
<clause commented="no" display-inline="no-display-inline" id="H0417FEB43D864FC18CDDA21DE531FF65"><enum>(i)</enum><header display-inline="yes-display-inline">Period</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H33B6CBE9892B4C6FB2D53E18B035E45B"><enum>(ii)</enum><header display-inline="yes-display-inline">Response to reaccreditation
request</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HBA295E95AE7D441ABF0B71C7F5057AC6"><enum>(iii)</enum><header display-inline="yes-display-inline">Criteria</header><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H2E5964D022684B79BB8077AB974CBE5B"><enum>(b)</enum><header display-inline="yes-display-inline">Duration of authority</header><text display-inline="yes-display-inline">Section 523(c) (21 U.S.C. 360m(c)) is
amended by striking <quote>October 1, 2012</quote> and inserting <quote>October
1, 2017</quote>.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H7A145E8C8BD5426293E70FFD25B249CF" section-type="subsequent-section"><enum>612.</enum><header display-inline="yes-display-inline">Reauthorization of third-party
inspection</header><text display-inline="no-display-inline">Section 704(g)(11)
(21 U.S.C. 374(g)(11)) is amended by striking <quote>October 1, 2012</quote>
and inserting <quote>October 1, 2017</quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="HD976C464CDA2451F8CD16E378F3DCB99" section-type="subsequent-section"><enum>613.</enum><header display-inline="yes-display-inline">Humanitarian device exemptions</header>
<subsection commented="no" display-inline="no-display-inline" id="H6E7DD303665F4A11A429701D6288848D"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 520(m) (21 U.S.C. 360j(m)) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HAC0557889DE24B0AB7F8FB2E11CB6058"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (6)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H74940FC968E84F48AF1959207F5C53F9"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text>
<clause commented="no" display-inline="no-display-inline" id="H810EACA059594B74BD414308C697ED89"><enum>(i)</enum><text display-inline="yes-display-inline">by striking clause (i) and inserting the
following:</text>
<quoted-block display-inline="no-display-inline" id="H733ACF9C82B148CDB15E28805868FD4F" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="H9830E4C867FE40289FCC9C2CB0C8F325" indent="up2"><enum>(i)</enum><text display-inline="yes-display-inline">The device with respect to which the
exemption is granted—</text>
<subclause commented="no" display-inline="no-display-inline" id="H0A8AA96ED80D49398C2E89505772090E"><enum>(I)</enum><text display-inline="yes-display-inline">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</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HB915F456AF9B407A9DFEF40BE5D2FA8B"><enum>(II)</enum><text display-inline="yes-display-inline">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.</text>
</subclause></clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause><clause commented="no" display-inline="no-display-inline" id="H0F3BBB67156544B6A192561F1CD98011"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking clause (ii) and inserting the
following:</text>
<quoted-block display-inline="no-display-inline" id="HA6F9035AAEDE4DBCAFAEA10B3141E93C" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="H862AAB90DB0347A8AF3A8958BFEA2B23" indent="up2"><enum>(ii)</enum><text display-inline="yes-display-inline">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 <term>annual distribution number</term> 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.</text>
</clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H64382B62FA7946A88F5052547F50B3C4"><enum>(B)</enum><text display-inline="yes-display-inline">by amending subparagraph (C) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="H83D0E3767DE64FBDBB168673DFBDD91A" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H7E4BFA00915E4472A6B12D64084E40A1" indent="up2"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC2051100F74A42719D139091E1FF705D"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (7), by striking
<quote>regarding a device</quote> and inserting <quote>regarding a device
described in paragraph (6)(A)(i)(I)</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0895F399B1FE4F6D81CF1BFB92632B7B"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (8), by striking <quote>of all
devices described in paragraph (6)</quote> and inserting <quote>of all devices
described in paragraph (6)(A)(i)(I)</quote>.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H95A26C5A854E4ECF96169101B9E133D2"><enum>(b)</enum><header display-inline="yes-display-inline">Applicability to existing
devices</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HA55BE5D4711D4CF480215DF6553A07BE" section-type="subsequent-section"><enum>614.</enum><header display-inline="yes-display-inline">Unique device identifier</header><text display-inline="no-display-inline">Section 519(f) (21 U.S.C. 360i(f)) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H7E43289A49794982B4EFEC5ED2EDD5A8"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>The Secretary shall
promulgate</quote> and inserting <quote>Not later than December 31, 2012, the
Secretary shall issue proposed</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF455B7445946468F8BB8636C446A4385"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:
<quote>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.</quote>.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H2920B5010DE14738887D201F59B612C5" section-type="subsequent-section"><enum>615.</enum><header display-inline="yes-display-inline">Sentinel</header><text display-inline="no-display-inline">Section 519 (21 U.S.C. 360i) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HA5938B0AF0304D06AD890B9C3FB7E192" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H0ADE017634CC432DA15F846E69B60F38"><enum>(h)</enum><header display-inline="yes-display-inline">Inclusion of devices in the postmarket risk
identification and analysis system</header>
<paragraph commented="no" display-inline="no-display-inline" id="H68DA70236E28405CBED3D8F96F30F240"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H0B745E05211A4715A072DE501E0C4087"><enum>(A)</enum><header display-inline="yes-display-inline">Application to devices</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2534D9B56D6A4729B413ACE25BA53F47"><enum>(B)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">Subclause (II) of clause (i) of section
505(k)(3)(C) shall not apply to devices.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAE1FC48A1B8A45A58F8FF7F20BAFE636"><enum>(C)</enum><header display-inline="yes-display-inline">Clarification</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD771739932404DFF90A37DBF2CE9F522"><enum>(2)</enum><header display-inline="yes-display-inline">Data</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD80FC72D1B854568881E936C7BB57BD7"><enum>(3)</enum><header display-inline="yes-display-inline">Stakeholder input</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD1406BE2830B4F9496759A3D19470BC7"><enum>(4)</enum><header display-inline="yes-display-inline">Voluntary surveys</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="HE5663FF3519F4B2199EA037917FA9A8C" section-type="subsequent-section"><enum>616.</enum><header display-inline="yes-display-inline">Postmarket surveillance</header><text display-inline="no-display-inline">Section 522 (21 U.S.C. 360l) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H0192D41427EA4D4080ED509077471685"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)(1)(A), in the matter
preceding clause (i), by inserting <quote>, at the time of approval or
clearance of a device or at any time thereafter,</quote> after <quote>by
order</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H942CFCC237654201A632297A5B4DA230"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)(1), by inserting
<quote>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.</quote> after the second sentence.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="HB3D7D97E0A9242D89FB71A90DE89909A" section-type="subsequent-section"><enum>617.</enum><header display-inline="yes-display-inline">Custom
devices</header><text display-inline="no-display-inline">Section 520(b) (21
U.S.C. 360j(b)) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H130774E2894746D09A5FDD0CAD6F1A72" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HEF33CCDAF0204548A188792258359934"><enum>(b)</enum><header display-inline="yes-display-inline">Custom devices</header>
<paragraph commented="no" display-inline="no-display-inline" id="H7A2F761D915740489C68B69FBB18120D"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The requirements of sections 514 and 515
shall not apply to a device that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HBF16FEBCDD5A43E3B23BB70890C8613F"><enum>(A)</enum><text display-inline="yes-display-inline">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);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE91F5185C1EF48799495A93A99CA99A7"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBBC22C89181941E39F2CB6E03F015B9F"><enum>(C)</enum><text display-inline="yes-display-inline">is not generally available in the United
States in finished form through labeling or advertising by the manufacturer,
importer, or distributor for commercial distribution;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4DD30C1ADF8C4D27866812E3ADD945AB"><enum>(D)</enum><text display-inline="yes-display-inline">is designed to treat a unique pathology or
physiological condition that no other device is domestically available to
treat;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H022B50BB628245C382F84CFC475A9394"><enum>(E)</enum><clause commented="no" display-inline="yes-display-inline" id="H06EEE690446F4EEDBFE013AE6CEA707C"><enum>(i)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HF0A97B3D9E4F4891BB2856DE61EF64B6" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">is intended for use by an individual
patient named in such order of such physician or dentist (or other specially
qualified person so designated);</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9AA923F8E1014044A7AB4BA5A2251AC6"><enum>(F)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBE5125FC8A1D456AB8D48BE89FA107FE"><enum>(G)</enum><text display-inline="yes-display-inline">may have common, standardized design
characteristics, chemical and material compositions, and manufacturing
processes as commercially distributed devices.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA51F48E7F7934BEFB7708BA8A5D191A9"><enum>(2)</enum><header display-inline="yes-display-inline">Limitations</header><text display-inline="yes-display-inline">Paragraph (1) shall apply to a device only
if—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HBC447B48E9E841F6AA21C919B6F1E8EC"><enum>(A)</enum><text display-inline="yes-display-inline">such device is for the purpose of treating
a sufficiently rare condition, such that conducting clinical investigations on
such device would be impractical;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H02FC5A25B09D4794B1A9AF387B6C397D"><enum>(B)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H742E27E4B74543B5871AA58531E14EFF"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9F0481CC5F3842C282861E35AA3FF487"><enum>(3)</enum><header display-inline="yes-display-inline">Guidance</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H37AA258F4AA0430584E339C2CBBC2BF1" section-type="subsequent-section"><enum>618.</enum><header display-inline="yes-display-inline">Health information technology</header>
<subsection commented="no" display-inline="no-display-inline" id="HCB1E33337251413990E48A4405C12B59"><enum>(a)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">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 <quote>Secretary</quote>), 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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H3816F924CEE648EFA8D94D6571D5FC9D"><enum>(b)</enum><header display-inline="yes-display-inline">Working group</header>
<paragraph commented="no" display-inline="no-display-inline" id="H1466325BBB3B4576BCB2B15D12AFE266"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H74E2A01CC23945B481D901A6707D60E2"><enum>(2)</enum><header display-inline="yes-display-inline">Representatives</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H02ED1151E2474DE8B4EEC7BCFAD32BAB" section-type="subsequent-section"><enum>619.</enum><header display-inline="yes-display-inline">Good guidance practices relating to
devices</header><text display-inline="no-display-inline">Subparagraph (C) of
section 701(h)(1) (21 U.S.C. 371(h)(1)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HA075C1F2D8134DB488B3A9AD063D9A9B"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>(C) For guidance
documents</quote> and inserting <quote>(C)(i) For guidance documents</quote>;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H226E1B375BBC4ED1843C4A68DA8D6BA1"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H0ADAEECB06F94BFDBE4AB0329CC9BB21" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="HB53D281A5DC745C3A16A988907C847CB" indent="up2"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H4ADE9FEC124E4463B27D85B0C6E7E678" section-type="subsequent-section"><enum>620.</enum><header display-inline="yes-display-inline">Pediatric device consortia</header>
<subsection commented="no" display-inline="no-display-inline" id="H4239F45059C74593979417876003C8B9"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 <quote>$6,000,000 for each of fiscal years 2008 through
2012</quote> and inserting <quote>$5,250,000 for each of fiscal years 2013
through 2017</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HBCAA540BE5FA4B93A8F9EFC014DBC203"><enum>(b)</enum><header display-inline="yes-display-inline">Final rule relating To tracking of
pediatric uses of devices</header><text display-inline="yes-display-inline">The
Secretary of Health and Human Services shall issue—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H2510616EFFAF42F891CF05D2DFB5984F"><enum>(1)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE1F510D9419A42F3BE526D76F5932A6B"><enum>(2)</enum><text display-inline="yes-display-inline">a final rule implementing such section not
later than December 31, 2013.</text>
</paragraph></subsection></section><enum>VII</enum><header display-inline="yes-display-inline">Drug supply chain</header>
<section commented="no" display-inline="no-display-inline" id="H22568E45F4794D9AA9367C9BB1DA9ED3" section-type="subsequent-section"><enum>701.</enum><header display-inline="yes-display-inline">Registration of domestic drug
establishments</header><text display-inline="no-display-inline">Section 510 (21
U.S.C. 360) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HCAC42C149C8A48EE8B0A7B56B1405A5A"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (b)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H5B9AD54967E243BF8CE837646E150A36"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>On or
before</quote> 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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6B935CD78D6244549BB79A56F0B6BC69"><enum>(B)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H258CC1C12A274C83BF874045342B1CD1" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H3A70C0CE61E349F8AB73A6D774B93C09" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD01E84E779504990980F5DF71FF3587F"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (c), by striking <quote>with
the Secretary his name, place of business, and such establishment</quote> and
inserting “with the Secretary—</text>
<quoted-block display-inline="no-display-inline" id="H675B4756FE3349BCBF6C43BF89A799F1" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H95FDF50602E14BECB1FDAE9FE6CBF45A"><enum>(1)</enum><text display-inline="yes-display-inline">with respect to drugs, the information
described under subsection (b)(1); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFF2CF44F42494A4BBBBC5D49C5252477"><enum>(2)</enum><text display-inline="yes-display-inline">with respect to devices, the information
described under subsection
(b)(2).</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H9C8FD0F956914294A65377CA1EC5E45F" section-type="subsequent-section"><enum>702.</enum><header display-inline="yes-display-inline">Registration of foreign
establishments</header>
<subsection commented="no" display-inline="no-display-inline" id="HCC979D7E23CF48C783122D5E71A9531B"><enum>(a)</enum><header display-inline="yes-display-inline">Enforcement of registration of foreign
establishments</header><text display-inline="yes-display-inline">Section 502(o)
(21 U.S.C. 352(o)) is amended by striking <quote>in any State</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H90C5EA4EC8174B2BB2708338CFCE0988"><enum>(b)</enum><header display-inline="yes-display-inline">Registration of foreign drug
establishments</header><text display-inline="yes-display-inline">Section 510(i)
(U.S.C. 360(i)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H5837B052EA4D4DDD9F363CF4A9C1416F"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HAC621994ACAF4D15AEBDF1EAEA736C7C"><enum>(A)</enum><text display-inline="yes-display-inline">by amending the matter preceding
subparagraph (A) to read as follows: <quote>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—</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDE827BF3C31A4400A8D3F576AFBC7385"><enum>(B)</enum><text display-inline="yes-display-inline">by amending subparagraph (A) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="H5C18B132DDB24B4DA5193FE7F1394E1A" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H9298A51986634AB1A9764013AABA148A" indent="up1"><enum>(A)</enum><text display-inline="yes-display-inline">upon first engaging in any such activity,
immediately submit a registration to the Secretary that includes—</text>
<clause commented="no" display-inline="no-display-inline" id="HFC3C2900EE12416E9EA350695EA77DC4"><enum>(i)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H68EF96B022F64F9EA8938D99EFB0355C"><enum>(ii)</enum><text display-inline="yes-display-inline">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</text>
</clause></subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF2B56D82A46740C4BA2570AF48657413"><enum>(C)</enum><text display-inline="yes-display-inline">by amending subparagraph (B) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="HA3DD82C9C58647349C7EDB5EC646C8AE" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="HF52EE99AD06F40F78E506E77BDE32FE3" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9B15BAA3ECFF4F69934F6226717BB4CC"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HD2BD2CBD25E74EB88D00A377AD2F471F" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="HD70681AB658C464DA990711C78748DA8" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H01427980F5EB493F91ACC752F6BEFA9A" section-type="subsequent-section"><enum>703.</enum><header display-inline="yes-display-inline">Identification of drug excipient
information with product listing</header><text display-inline="no-display-inline">Section 510(j) (21 U.S.C. 360(j)) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H0F50FD2A3DE0430FBE20CBB336D3B633"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HD21269E110EF48539F4192A115020DA8"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (C), by striking <quote>;
and</quote> and inserting a semicolon;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD84D7F14F84C41D7A2AA93E079EEA063"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (D), by striking the period
at the end and inserting <quote>; and</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8D864ACF0EB84096BB4479B45605D2DC"><enum>(C)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H12131D77A42B48C88542650E96381E5D" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="HFAE45E50AC6144EC8914C51DF5F98C14" indent="up1"><enum>(E)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H36D26F6C1AFB4C05B5EC510F7F7CCF45"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H35236B6AFE284320A103C11357AF394E" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="HEFA9F4ABD606449CB75E0F448C806E94" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H89CDACB7D0C841C392D0E99B2B96F0C7" section-type="subsequent-section"><enum>704.</enum><header display-inline="yes-display-inline">Electronic system for registration and
listing</header><text display-inline="no-display-inline">Section 510(p) (21
U.S.C. 360(p)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HB21BBC982DA44F16ABACABBCC241C9D3"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>(p) Registrations and
listings</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="H73C57B0C905D430990D11ECB2463C979" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H4AD79FB1DF9543709C08494E73A45575"><enum>(p)</enum><header display-inline="yes-display-inline">Electronic registration and
listing</header>
<paragraph commented="no" display-inline="no-display-inline" id="H0E4C8520EAAF46998ABAE7A363FFF6AB"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Registrations and
listings</text>
</paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2BBCB00630824C319DCFE4410353D5D6"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H1D7C908DB1D840BC8ED2CBB0664A3838" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H82D8D40A9C094BAC8E265D2969CF3685"><enum>(2)</enum><header display-inline="yes-display-inline">Electronic database</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H72287B8C13C04019B9485182776517E2"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5AF549BD16A042FAA41677684B6786C9"><enum>(B)</enum><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC8BE3A61FE424BD1932009AC869837A7"><enum>(3)</enum><header display-inline="yes-display-inline">Risk-based information and
coordination</header><text display-inline="yes-display-inline">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).</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H920CDDA8495744848464D8B3E3951FBE" section-type="subsequent-section"><enum>705.</enum><header display-inline="yes-display-inline">Risk-based inspection
frequency</header><text display-inline="no-display-inline">Section 510(h) (21
U.S.C. 360(h)) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H7BC3CCC695FB4C5197289DC08A793A33" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HA765C9DD9B7D4878AE866716012341C1"><enum>(h)</enum><header display-inline="yes-display-inline">Inspections</header>
<paragraph commented="no" display-inline="no-display-inline" id="HA50231F382DB46DAB536CB60F34F9779"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Every establishment that is required to be
registered with the Secretary under this section shall be subject to inspection
pursuant to section 704.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD8F52FD11F004627A0C6207C5991BBAB"><enum>(2)</enum><header display-inline="yes-display-inline">Biennial inspections for
devices</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6591ED22DEAF4A1E8EF5A414ECFC1AC3"><enum>(3)</enum><header display-inline="yes-display-inline">Risk-based schedule for drugs</header><text display-inline="yes-display-inline">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 <quote>drug establishments</quote>) in
accordance with a risk-based schedule established by the Secretary.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H14FDF092ABA84776BBCCA3343F16F815"><enum>(4)</enum><header display-inline="yes-display-inline">Risk factors</header><text display-inline="yes-display-inline">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:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HB1AEF57B14D945A5B9D2665349191476"><enum>(A)</enum><text display-inline="yes-display-inline">The compliance history of the
establishment.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3B18BC18618D4DBC9E1F160287A9CC6A"><enum>(B)</enum><text display-inline="yes-display-inline">The record, history, and nature of recalls
linked to the establishment.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3F0C3ECC371E47FFBC84DE73214ED58A"><enum>(C)</enum><text display-inline="yes-display-inline">The inherent risk of the drug manufactured,
prepared, propagated, compounded, or processed at the establishment.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAAE1572365A64FAD86621012498201D2"><enum>(D)</enum><text display-inline="yes-display-inline">The inspection frequency and history of the
establishment, including whether the establishment has been inspected pursuant
to section 704 within the last 4 years.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDF600EDDBC0E4512BB0E9E4A4312B341"><enum>(E)</enum><text display-inline="yes-display-inline">Whether the establishment has been
inspected by a foreign government or an agency of a foreign government
recognized under section 809.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H195E02D9C40B4501B9080D444BA5CEDA"><enum>(F)</enum><text display-inline="yes-display-inline">Any other criteria deemed necessary and
appropriate by the Secretary for purposes of allocating inspection
resources.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H42159E48F63F4CD9BCA6AB6EDCB87C2F"><enum>(5)</enum><header display-inline="yes-display-inline">Effect of status</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2565FF0B553946F8BA5E58D2A203F780"><enum>(6)</enum><header display-inline="yes-display-inline">Annual report on inspections of
establishments</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H966EE65858684CC38D2DEB091F081AAD"><enum>(A)</enum><clause commented="no" display-inline="yes-display-inline" id="H880C01A2950F46E5865867A13E6EEEE2"><enum>(i)</enum><text display-inline="yes-display-inline">the number of domestic and foreign
establishments registered pursuant to this section in the previous fiscal year;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HE2370A48D64C4743A7336DA6FC47ACA4" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">the number of such domestic establishments
and the number of such foreign establishments that the Secretary inspected in
the previous fiscal year;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB19281DFEBA744EC98EB5AD28050D943"><enum>(B)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAC0F701C69ED4CF3BFC77E4E36150036"><enum>(C)</enum><text display-inline="yes-display-inline">the percentage of the budget of the Food
and Drug Administration used to fund the inspections described under
subparagraph
(A).</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H3D91FCF371F243ADB791AFAF142524AC" section-type="subsequent-section"><enum>706.</enum><header display-inline="yes-display-inline">Records for inspection</header><text display-inline="no-display-inline">Section 704(a) (21 U.S.C. 374(a)) is amended
by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H0215080826964716815E6F58EDF06EDC" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H4AAD3278CDB645989E8127A1222FAA8B" indent="up1"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HCA8DD567B5D64206BF9C36DD499DB42E"><enum>(A)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9FE09B9964964DF39BD254EEF9593843" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">Upon receipt of the records requested under
<internal-xref idref="HCA8DD567B5D64206BF9C36DD499DB42E" legis-path="(4)(A)">subparagraph (A)</internal-xref>, the Secretary shall
provide to the person confirmation of receipt.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5DAA4296E4EA414EA8E3B2ECF402B2FA" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="HE0425904E9B449E788EFAFCAA2AE9FBC" section-type="subsequent-section"><enum>707.</enum><header display-inline="yes-display-inline">Prohibition against delaying, denying,
limiting, or refusing inspection</header>
<subsection commented="no" display-inline="no-display-inline" id="H35494FFF497345AA98E524A9A54A9AE2"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 501 (21 U.S.C. 351) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H7DB6EA7B122D42CFA01C04EF7FFF5AFC" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H5BACF4CB2420435CBBAFD44A50DF0709"><enum>(j)</enum><text display-inline="yes-display-inline">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.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HE56F9E12D6514D35AF407FD9A94E4337"><enum>(b)</enum><header display-inline="yes-display-inline">Guidance</header><text display-inline="yes-display-inline">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
<internal-xref idref="H35494FFF497345AA98E524A9A54A9AE2" legis-path="805.(a)">subsection (a)</internal-xref>).</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HF20AE9AF9D414BC0B595BD8CFEA827F0" section-type="subsequent-section"><enum>708.</enum><header display-inline="yes-display-inline">Destruction of adulterated, misbranded, or
counterfeit drugs offered for import</header>
<subsection commented="no" display-inline="no-display-inline" id="HDF190A771EB64540BD81D898E6116E8F"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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: <quote>, 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).</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H9C8302CB78B34C7D9A381A4585D05792"><enum>(b)</enum><header display-inline="yes-display-inline">Notice</header><text display-inline="yes-display-inline">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: <quote>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.</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HEC3C8955E7284D9CAD0684C9A76B828B"><enum>(c)</enum><header display-inline="yes-display-inline">Applicability</header><text display-inline="yes-display-inline">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).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H9C79057EA5CA46DA9AFC81175022F853"><enum>(d)</enum><header display-inline="yes-display-inline">Regulations</header>
<paragraph commented="no" display-inline="no-display-inline" id="HF4915A8756C241DB984A96991B742823"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1F582CE14C794F26B53226394CD29591"><enum>(2)</enum><header display-inline="yes-display-inline">Procedure</header><text display-inline="yes-display-inline">In promulgating a regulation implementing
the amendments made by this section, the Secretary of Health and Human Services
shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HCB7691C6B24246E98BE9DBDB2C531966"><enum>(A)</enum><text display-inline="yes-display-inline">issue a notice of proposed rulemaking that
includes a copy of the proposed regulation;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBE261A9729764180807487516DDAB53D"><enum>(B)</enum><text display-inline="yes-display-inline">provide a period of not less than 60 days
for comments on the proposed regulation; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC3FEDD5AFD1643B08978C6C3FFABF3F2"><enum>(C)</enum><text display-inline="yes-display-inline">publish the final regulation not less than
30 days before the effective date of the regulation.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1D434A8037FF4C31BAD07CF89A64835D"><enum>(3)</enum><header display-inline="yes-display-inline">Restrictions</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="HD90F10D4E4CF4698A69026098FF4F954" section-type="subsequent-section"><enum>709.</enum><header display-inline="yes-display-inline">Administrative detention</header>
<subsection commented="no" display-inline="no-display-inline" id="H43C0FBEC898944D79B7BC1BA1EF0C826"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 304(g) (21 U.S.C. 335a(g)) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H732F28652D6F44CC949E49143E29F5E0"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1), by inserting <quote>,
drug,</quote> after <quote>device</quote>, each place it appears;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H91142010E0684411A0A2FAC5D47D0C2C"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2)(A), by inserting <quote>,
drug,</quote> after <quote>(B), a device</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H95BF7AE615F3405BB2E02CDEBC61ED14"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (2)(B), by inserting <quote>or
drug</quote> after <quote>device</quote> each place it appears.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H32E3D2443EDA42FDB11E4593B7374D8B"><enum>(b)</enum><header display-inline="yes-display-inline">Regulations</header>
<paragraph commented="no" display-inline="no-display-inline" id="H6F18B4FA344C4ACF8039BA51CB78CDEC"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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
<internal-xref idref="H43C0FBEC898944D79B7BC1BA1EF0C826" legis-path="807.(a)">subsection (a)</internal-xref>. Before promulgating such
regulations, the Secretary shall consult with stakeholders, including
manufacturers of drugs.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBF7BAAFDF41244EDBC06991C7BA6BF1D"><enum>(2)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 304 (21 U.S.C. 334) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HEC8D0A996C79408B94D37578E54E3C16" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H76B2B9685DA74AD7A120FF050FCC6668"><enum>(i)</enum><header display-inline="yes-display-inline">Procedures for promulgating
regulations</header>
<paragraph commented="no" display-inline="no-display-inline" id="HD0B1F6A9560741BE9B7BFF7A0B1A0727"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In promulgating a regulation implementing
this section, the Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H9FA33A8C66754B398311CE9D96865414"><enum>(A)</enum><text display-inline="yes-display-inline">issue a notice of proposed rulemaking that
includes the proposed regulation;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3D5DA04E49E847D6A68AE7EBF1F04886"><enum>(B)</enum><text display-inline="yes-display-inline">provide a period of not less than 60 days
for comments on the proposed regulation; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD7468E39CF1D42DEBD28F5C08B1F4FE5"><enum>(C)</enum><text display-inline="yes-display-inline">publish the final regulation not less than
30 days before the regulation’s effective date.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H48662D56A0A54641BD92731DF04CC303"><enum>(2)</enum><header display-inline="yes-display-inline">Restrictions</header><text display-inline="yes-display-inline">Notwithstanding any other provision of
Federal law, in implementing this section, the Secretary shall only promulgate
regulations as described in paragraph
(1).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H52CE272BE31E4E1499FFCFEEA2385881"><enum>(c)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendments made by
<internal-xref idref="H43C0FBEC898944D79B7BC1BA1EF0C826" legis-path="807.(a)">subsection (a)</internal-xref> shall not take effect until
the Secretary has issued a final regulation under
<internal-xref idref="H32E3D2443EDA42FDB11E4593B7374D8B" legis-path="807.(b)">subsection (b)</internal-xref>.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H316404E3893A41F49B1D9E01FE30D8E2" section-type="subsequent-section"><enum>710.</enum><header display-inline="yes-display-inline">Exchange of information</header><text display-inline="no-display-inline">Section 708 (21 U.S.C. 379) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H65C6785AACEE41F0B978D8465C5AEE2A"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote><header-in-text level="section" style="traditional">Confidential
Information</header-in-text></quote> and all that follows through <quote>The
Secretary may provide</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="H25D1C45CEE9B4261B48338BE0F36EB2F" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HC83980644390459782409BE43D0F4743" section-type="subsequent-section"><enum>708.</enum><header display-inline="yes-display-inline">Confidential information</header>
<subsection commented="no" display-inline="no-display-inline" id="HF6106301D7B042299D2EE777285F4D37"><enum>(a)</enum><header display-inline="yes-display-inline">Contractors</header><text display-inline="yes-display-inline">The Secretary may
provide</text>
</subsection></section><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD1A1B2D77A6B4E48A101B80C38E9EA80"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HD6B2912BF54443DAB2350764C772209B" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H69D4A3518F214A08894CCAEE5E87577B"><enum>(b)</enum><header display-inline="yes-display-inline">Ability To receive and protect confidential
information obtained from foreign governments</header>
<paragraph commented="no" display-inline="no-display-inline" id="H516968D7AB834C2F87B48BEEFE1DAE1F"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall not be required to
disclose under section 552 of title 5, United States Code (commonly referred to
as the <quote>Freedom of Information Act</quote>), or any other provision of
law, any information relating to drugs obtained from a foreign government
agency, if—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H3DC8FF90771C4EF8B2B73A5B0B33F759"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H63E281B9B91849B0BB39B01D8840AAD7"><enum>(B)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H041E7FA6D26141FFA0DDA14F83E1EFF4"><enum>(C)</enum><text display-inline="yes-display-inline">the information is covered by, and subject
to, a written agreement between the Secretary and the foreign
government.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDEC9A840493145B5BC43BA7A1D1728AF"><enum>(2)</enum><header display-inline="yes-display-inline">Time limitations</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H15918134AEDC4E70831516791AE1090D"><enum>(3)</enum><header display-inline="yes-display-inline">Disclosures not affected</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF86BF1EC8AF249CC9312E517348A9C7B"><enum>(4)</enum><header display-inline="yes-display-inline">Relation to other law</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H115F00A2FFFE444493EA956DFD0692A4"><enum>(c)</enum><header display-inline="yes-display-inline">Authority To enter into memoranda of
understanding for purposes of information exchange</header><text display-inline="yes-display-inline">The
Secretary may enter into written agreements to provide information referenced
in section 301(j) to foreign governments subject to the following
criteria:</text>
<paragraph commented="no" display-inline="no-display-inline" id="H6A5352DC1A904143A73D1A2DA7594809"><enum>(1)</enum><header display-inline="yes-display-inline">Certification</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1FA0A077FFA74EDAA4710A33EE71D2C2"><enum>(2)</enum><header display-inline="yes-display-inline">Written agreement</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H96C5B3E16B7049AB9C153569438B9857"><enum>(3)</enum><header display-inline="yes-display-inline">Information exchange</header><text display-inline="yes-display-inline">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:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HA7CA3483BD8A42FD92B5170322507102"><enum>(A)</enum><text display-inline="yes-display-inline">Information concerning the inspection of a
facility may be provided to a foreign government if—</text>
<clause commented="no" display-inline="no-display-inline" id="H5DA08F00D6834F23A0A099A4AC4DF23B"><enum>(i)</enum><text display-inline="yes-display-inline">the Secretary reasonably believes, or the
written agreement described in paragraph (2) establishes, that the government
has authority to otherwise obtain such information; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HDA041A663FB344CEA6C4B0A27A84AC73"><enum>(ii)</enum><text display-inline="yes-display-inline">the written agreement executed under
paragraph (2) limits the recipient’s use of the information to the recipient’s
civil regulatory purposes.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE3A42E71BD3548F78F5B6C2B51FBB6AF"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBDE10957F51B4B82A81E832A2D1A4ADD"><enum>(4)</enum><header display-inline="yes-display-inline">Effect of subsection</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H82E4C373578441AB825C36240043F1AD" section-type="subsequent-section"><enum>711.</enum><header display-inline="yes-display-inline">Enhancing the safety and quality of the
drug supply</header><text display-inline="no-display-inline">Section 501 (21
U.S.C. 351) is amended by adding at the end the following flush text:</text>
<quoted-block display-inline="no-display-inline" id="HEAF3F7C419094445A16F34D47C54A717" style="OLC">
<quoted-block-continuation-text commented="no" quoted-block-continuation-text-level="section">For purposes of paragraph (a)(2)(B),
the term <term>current good manufacturing practice</term> 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.</quoted-block-continuation-text><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H6BC0EE2384AB425F81C572FF3E7A89CF" section-type="subsequent-section"><enum>712.</enum><header display-inline="yes-display-inline">Recognition of foreign government
inspections</header><text display-inline="no-display-inline">Chapter VIII (21
U.S.C. 381 et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HD06CC47E8562476DA894FB5BA80CE081" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HC9170CAA2828470FAC91B5E4F4B201D9" section-type="subsequent-section"><enum>809.</enum><header display-inline="yes-display-inline">Recognition of foreign government
inspections</header>
<subsection commented="no" display-inline="no-display-inline" id="H78AA1A8D5A6C4F58B4947F0AB1A69BE0"><enum>(a)</enum><header display-inline="yes-display-inline">Inspection</header><text display-inline="yes-display-inline">The Secretary—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H50F919F179C94D36B836E453B1F0C9AE"><enum>(1)</enum><text display-inline="yes-display-inline">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);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9A2C68712DE4444DBDDBFC0447466C3D"><enum>(2)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H25924FB125524ABE8CF6317DCD598F1A"><enum>(3)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HFABF106BFA454846843F444D29640796"><enum>(b)</enum><header display-inline="yes-display-inline">Results of inspection</header><text display-inline="yes-display-inline">The results of inspections performed by a
foreign government or an agency of a foreign government under this section may
be used as—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H36F5E300CE044834B149BE4C3B333E67"><enum>(1)</enum><text display-inline="yes-display-inline">evidence of compliance with section
501(a)(2)(B) or section 801(r); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD7FF6BABD683479F983A236C4CFECF23"><enum>(2)</enum><text display-inline="yes-display-inline">for any other purposes as determined
appropriate by the
Secretary.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="HD779F4CC4D4E401AA146334F1C5D4630" section-type="subsequent-section"><enum>713.</enum><header display-inline="yes-display-inline">Standards for admission of imported
drugs</header><text display-inline="no-display-inline">Section 801 (21 U.S.C.
381) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HD8F69BA342CD477FA1FA1032A98FE100"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (o), by striking <quote>drug
or</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEA9D6E07CC0740A5A510B8A5A5C84BEC"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H9F4C0A00AF054E14846A40446498BFF7" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H1ABB0671A0A04044B248B4E0E36CC516"><enum>(r)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H2016B19BE5B8490796AE35A229328BC6"><enum>(1)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1BC2D6FE994441B7A68BE89FE50FA638" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">The information described under paragraph
(1) may include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H32E6D8D7205947E1B4242C0AC02E4CC3"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H228ECC9453284104806EFCA8EBEACE2B"><enum>(B)</enum><text display-inline="yes-display-inline">facility information, such as proof of
registration and the unique facility identifier;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD5FD9C99D6CC4AF6AC7411D4703E695C"><enum>(C)</enum><text display-inline="yes-display-inline">indication of compliance with current good
manufacturing practice, testing results, certifications relating to
satisfactory inspections, and compliance with the country of export
regulations; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H68B8637F9F9D4D5480B7090DAAEBDA6E"><enum>(D)</enum><text display-inline="yes-display-inline">any other information deemed necessary and
appropriate by the Secretary to assess compliance of the article being offered
for import.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2C01C03C471A4174BFDA06C4FD839996" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">Information requirements referred to in
paragraph (2)(C) may, at the discretion of the Secretary, be satisfied—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HB8B755B6CE95408788AE41C114A861C1"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1785058B54AE496AB3E88E0D55E654B6"><enum>(B)</enum><text display-inline="yes-display-inline">through representation by a foreign
government or an agency of a foreign government recognized under section 809;
or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9FF812AA3B394E469A6224B8140364CE"><enum>(C)</enum><text display-inline="yes-display-inline">other appropriate documentation or evidence
as described by the Secretary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HED2218D6A0C848E8B1111B15872A25FE" indent="up1"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H226883C70F724123810EE7C5ABDCB7B9"><enum>(A)</enum><text display-inline="yes-display-inline">Not later than 18 months after the date of
enactment of the <short-title>Food and Drug Administration
Safety and Innovation Act</short-title>, 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).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6B99CBC2D3884A43A82444AFC8254E38" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">In promulgating the regulations under
subparagraph (A), the Secretary—</text>
<clause commented="no" display-inline="no-display-inline" id="HA3F35BB2606F42C59519B1D5ACFFA53D"><enum>(i)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H25E2F0D39B06428395FFFD20752F11FA"><enum>(ii)</enum><text display-inline="yes-display-inline">shall—</text>
<subclause commented="no" display-inline="no-display-inline" id="HE6786861BAC84B4B85E18DD657D18D29"><enum>(I)</enum><text display-inline="yes-display-inline">issue a notice of proposed rulemaking that
includes the proposed regulation;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H8A9C3B47E1134D18A6EEDD493BFAF89E"><enum>(II)</enum><text display-inline="yes-display-inline">provide a period of not less than 60 days
for comments on the proposed regulation; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H085973100C7A4811B76E816994A8F01F"><enum>(III)</enum><text display-inline="yes-display-inline">publish the final regulation not less than
30 days before the effective date of the regulation.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H70549A3F75A2466D8C66B001DCE97848" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">Notwithstanding any other provision of law,
the Secretary shall promulgate regulations implementing this subsection only as
described in subparagraph
(B).</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="HE58CCC82AB744FAA9BA7677B189B756A" section-type="subsequent-section"><enum>714.</enum><header display-inline="yes-display-inline">Registration of commercial
importers</header>
<subsection commented="no" display-inline="no-display-inline" id="HC64E95DF560E4A70B25FB11B8A0842C5"><enum>(a)</enum><header display-inline="yes-display-inline">Prohibitions</header><text display-inline="yes-display-inline">Section 301 (21 U.S.C. 331) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HD08EE17763E246F3B859D1C948241343" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HAB21C40CD0584E0DAF58E4935B53B3A4"><enum>(aaa)</enum><text display-inline="yes-display-inline">The failure to register in accordance with
section
801(s).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H8CBE0AAA5C4740E2ADEC7AF2674EE1CC"><enum>(b)</enum><header display-inline="yes-display-inline">Registration</header><text display-inline="yes-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="HE6F4DE786FCB406495E8E6BE066CDE97" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H6BA989EDAC5C4507B43048FFB05AC2CE"><enum>(s)</enum><header display-inline="yes-display-inline">Registration of commercial
importers</header>
<paragraph commented="no" display-inline="no-display-inline" id="HACEA09CDA14B43E1A279E1644B028947"><enum>(1)</enum><header display-inline="yes-display-inline">Registration</header><text display-inline="yes-display-inline">The Secretary shall require a commercial
importer of drugs—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HD00265CCA6884E5580CDCABA231CB871"><enum>(A)</enum><text display-inline="yes-display-inline">to be registered with the Secretary in a
form and manner specified by the Secretary; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H58B2B6E92A894373B3B4F50FD4227E75"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5FEC7C71B8744AB2BDE94C5CB600BDF9"><enum>(2)</enum><header display-inline="yes-display-inline">Regulations</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HDBC6B9E00DFC44EC856B5BADFB51ADD8"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1B5606831B144864B52B85EFB598F54B"><enum>(B)</enum><header display-inline="yes-display-inline">Procedure</header><text display-inline="yes-display-inline">In promulgating a regulation under
subparagraph (A), the Secretary shall—</text>
<clause commented="no" display-inline="no-display-inline" id="H8DC4F5BAC70F439BBB5BDFC588FC5D98"><enum>(i)</enum><text display-inline="yes-display-inline">issue a notice of proposed rulemaking that
includes the proposed regulation;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H7337D2A9359F4AB89B9F3EF281126BFE"><enum>(ii)</enum><text display-inline="yes-display-inline">provide a period of not less than 60 days
for comments on the proposed regulation; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HB918BC4AFA12453593297AAA3FA6FC8D"><enum>(iii)</enum><text display-inline="yes-display-inline">publish the final regulation not less than
30 days before the regulation’s effective date.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5EB5A45706854535A17B984744813017"><enum>(C)</enum><header display-inline="yes-display-inline">Restrictions</header><text display-inline="yes-display-inline">Notwithstanding any other provision of
Federal law, in implementing this subsection, the Secretary shall only
promulgate regulations as described in subparagraph (B).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB5A8E6BD95494488B4918CD865C119B3"><enum>(3)</enum><header display-inline="yes-display-inline">Discontinuance of
registration</header><text display-inline="yes-display-inline">The Secretary
shall discontinue the registration of any commercial importer of drugs that
fails to comply with the regulations promulgated under this subsection.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H75C5148B019B4E8E8531916C862122DD"><enum>(4)</enum><header display-inline="yes-display-inline">Unique facility identifier</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H285036E78E0D451C943E9B482F2E367F"><enum>(5)</enum><header display-inline="yes-display-inline">Exemptions</header><text display-inline="yes-display-inline">The Secretary, by notice in the Federal
Register, may establish exemptions from the requirements of this
subsection.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H928D72252DC346AA89158FBE1B19A2D0"><enum>(c)</enum><header display-inline="yes-display-inline">Misbranding</header><text display-inline="yes-display-inline">Section 502(o) (21 U.S.C. 352) is amended
by inserting <quote>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),</quote>
after <quote>not duly registered under section 510,</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H74ADE428A2664066A116441E7705AA30"><enum>(d)</enum><header display-inline="yes-display-inline">Regulations</header>
<paragraph commented="no" display-inline="no-display-inline" id="H2786647F56174A5C9E398F4C5B7CD8E3"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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
<internal-xref idref="H8CBE0AAA5C4740E2ADEC7AF2674EE1CC" legis-path="811.(b)">subsection (b)</internal-xref>.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4DE3F3B45CC04D0D88A3E9C93B4057F4"><enum>(2)</enum><header display-inline="yes-display-inline">Procedures for promulgating
regulations</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HB2219E7D1D4D46EFAC3D81442E12D437"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In promulgating a regulation under
paragraph (1), the Secretary shall—</text>
<clause commented="no" display-inline="no-display-inline" id="H61B59A60CEA24C9F93A19E6A50DB1AC7"><enum>(i)</enum><text display-inline="yes-display-inline">issue a notice of proposed rulemaking that
includes the proposed regulation;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HDAA40D8DAAFF4E459E5E16C3903B7E36"><enum>(ii)</enum><text display-inline="yes-display-inline">provide a period of not less than 60 days
for comments on the proposed regulation; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HEBC6AE7F2DE94E2E9622E11A84D5B19D"><enum>(iii)</enum><text display-inline="yes-display-inline">publish the final regulation not less than
30 days before the regulation’s effective date.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H11BD0B87BE1C417581A6EBA5BBF0FFCF"><enum>(B)</enum><header display-inline="yes-display-inline">Restrictions</header><text display-inline="yes-display-inline">Notwithstanding any other provision of
Federal law, in implementing section 801(s) of the Federal Food, Drug, and
Cosmetic Act, as added by
<internal-xref idref="H8CBE0AAA5C4740E2ADEC7AF2674EE1CC" legis-path="811.(b)">subsection (b)</internal-xref>, the Secretary shall
promulgate regulations only as described in subparagraph (A).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H06B4EEE8A01244A9B91C6B502B71BB32"><enum>(3)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">In establishing the
effective date of the regulations under
<internal-xref idref="H2786647F56174A5C9E398F4C5B7CD8E3" legis-path="811.(c)(1)">paragraph (1)</internal-xref>, 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.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="HAC02FADF489C442EA12ABD1AB0C82606" section-type="subsequent-section"><enum>715.</enum><header display-inline="yes-display-inline">Notification</header>
<subsection commented="no" display-inline="no-display-inline" id="H9FED78A06C82403CB645D136E4B7ED62"><enum>(a)</enum><header display-inline="yes-display-inline">Prohibited acts</header><text display-inline="yes-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="H65E809D52184497094EBF66E71AE7B20" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HBC29346795794D57A45B1B07B80DD74C"><enum>(bbb)</enum><text display-inline="yes-display-inline">The failure to notify the Secretary in
violation of section
568.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HDC1C37D407234C4BA909A6668B9E413A"><enum>(b)</enum><header display-inline="yes-display-inline">Notification</header><text display-inline="yes-display-inline">Subchapter E of chapter V (21 U.S.C. 360bbb
et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HF4CF8B14640D4E77A297D581EC845F75" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HDF43F9A88C0B4FE3B5EBCBB1FFD6897E" section-type="subsequent-section"><enum>568.</enum><header display-inline="yes-display-inline">Notification</header>
<subsection commented="no" display-inline="no-display-inline" id="HC19990DC4E28402C9053410DAD3A16D5"><enum>(a)</enum><header display-inline="yes-display-inline">Notification to Secretary</header><text display-inline="yes-display-inline">With respect to a drug, the Secretary may
require notification to the Secretary by a regulated person if the regulated
person knows—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H24D14E1C784942939E9B39DFAF69B958"><enum>(1)</enum><text display-inline="yes-display-inline">that the use of such drug in the United
States may result in serious injury or death;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H76DCFA6755B94DE09ABD6886A911EA89"><enum>(2)</enum><text display-inline="yes-display-inline">of a significant loss or known theft of
such drug intended for use in the United States; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC72CFD3AEACE4CFBBBB00E681021AAD4"><enum>(3)</enum><text display-inline="yes-display-inline">that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H978615FEBB7A4EA7B615FAD5BACBB96D"><enum>(A)</enum><text display-inline="yes-display-inline">such drug has been or is being
counterfeited; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1C2C6BCE08104350A07C6561F9298F85"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="H025171341949497E97D2DEB50CC5A0E2"><enum>(i)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H474C4B6104EB483DA3526CD093A61B4C" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H4DD6EB9EF8EB4209A8BB3F71CF69D052"><enum>(b)</enum><header display-inline="yes-display-inline">Manner of notification</header><text display-inline="yes-display-inline">Notification under this section shall be
made in such manner and by such means as the Secretary may specify by
regulation or guidance.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H70D603FC0B9148DEAF69AC129A60E42E"><enum>(c)</enum><header display-inline="yes-display-inline">Savings
clause</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H29B5D8C7FC3C41B395BE6C5B17F93E8A"><enum>(d)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">In this section, the term <term>regulated
person</term> means—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H36BC85E45B634CB683CA6A8ECB0A788D"><enum>(1)</enum><text display-inline="yes-display-inline">a person who is required to register under
section 510 or 801(s);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H420C46E8B7DC4ECBAB28878E7B544FD9"><enum>(2)</enum><text display-inline="yes-display-inline">a wholesale distributor of a drug product;
or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6C158DB6F9324D428701AAF664CE6DF7"><enum>(3)</enum><text display-inline="yes-display-inline">any other person that distributes drugs
except a person that distributes drugs exclusively for retail
sale.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H67CD236C2BD747BB8D737B2188DD0B68" section-type="subsequent-section"><enum>716.</enum><header display-inline="yes-display-inline">Protection against intentional
adulteration</header><text display-inline="no-display-inline">Section 303(b)
(21 U.S.C. 333(b)) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H34CDC81D1CB4413C9D86D28CE0A15F48" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H6184E2D7DBF741E58E2FD7ED815F865E" indent="up1"><enum>(7)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H692636B500FA4FF78884AC332387391F" section-type="subsequent-section"><enum>717.</enum><header display-inline="yes-display-inline">Penalties for counterfeiting drugs</header>
<subsection commented="no" display-inline="no-display-inline" id="HCDC9877E1F8740B48087D49C86CC1EE9"><enum>(a)</enum><header display-inline="yes-display-inline">Counterfeit drug penalty
enhancement</header>
<paragraph commented="no" display-inline="no-display-inline" id="HD7E8E3319C754730AADA9A600B13BE06"><enum>(1)</enum><header display-inline="yes-display-inline">Offense</header><text display-inline="yes-display-inline">Section 2320(a) of title 18, United States
Code, is amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HEDD8E841344241FE9EF3C5E836BFAA0B"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>or</quote> at the end of
paragraph (2);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA15138EFED7842D29CFC430A3F18D9CC"><enum>(B)</enum><text display-inline="yes-display-inline">by inserting <quote>or</quote> at the end
of paragraph (3);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEDCC1F9AFAE84BDD800FAB8CA70A9E21"><enum>(C)</enum><text display-inline="yes-display-inline">by inserting after paragraph (3) the
following:</text>
<quoted-block display-inline="no-display-inline" id="H0BE299F3BA3C49388AED7BB0A3C5741A" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H1A90C441BC6945169EC3CCAACFB43ADD"><enum>(4)</enum><text display-inline="yes-display-inline">traffics in a counterfeit
drug,</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB312718E61694090A2A1DA469C3968A9"><enum>(D)</enum><text display-inline="yes-display-inline">by striking <quote>through (3)</quote> and
inserting <quote>through (4)</quote>.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC3347D193A4E480BAD42B59ED8E6E2AD"><enum>(2)</enum><header display-inline="yes-display-inline">Penalties</header><text display-inline="yes-display-inline">Section 2320(b)(3) of title 18, United
States Code, is amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H29BFB7B2DB49485FB637C2606476D842"><enum>(A)</enum><text display-inline="yes-display-inline">in the heading, by inserting
<quote><header-in-text level="paragraph" style="OLC">and counterfeit
drugs</header-in-text></quote> after <quote><header-in-text level="paragraph" style="OLC">services</header-in-text></quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H065A30C0DBCB4B559910B02143ECCD13"><enum>(B)</enum><text display-inline="yes-display-inline">by inserting <quote>or counterfeit
drug</quote> after <quote>service</quote>.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H06830F8C17E24B838F5AD37C2EB48ACC"><enum>(3)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">Section 2320(f) of title 18, United States
Code, is amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H0B4ADCAABE384234B5C1A1AD5135329A"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>and</quote> at the end
of paragraph (4);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2689503BBCF446B4B0357096F212F367"><enum>(B)</enum><text display-inline="yes-display-inline">by striking the period at the end of
paragraph (5) and inserting <quote>; and</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA7813A5B456042CD8143EA86E47AA5B7"><enum>(C)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HB8E95255F7FC492E86A013C6154EF4B1" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H82C452AD8BF14248BE83DB22E9336125"><enum>(6)</enum><text display-inline="yes-display-inline">the term <term>counterfeit drug</term>
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.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9289FA242535468780EB9644E1F8F9CB"><enum>(4)</enum><header display-inline="yes-display-inline">Priority given to certain investigations
and prosecutions</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H53AC8641A95A4CC38BAB2297F9DFCE27"><enum>(b)</enum><header display-inline="yes-display-inline">Sentencing Commission Directive</header>
<paragraph commented="no" display-inline="no-display-inline" id="H4A7C8428E2A34C80A840611D00640F9F"><enum>(1)</enum><header display-inline="yes-display-inline">Directive to sentencing
commission</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB15D4D427D7647648622EDCE678A42F2"><enum>(2)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">In carrying out this subsection, the
Commission shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H62A37510CC1942C886D545CF8D39E69F"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HCB6D12CE5A454E078218C28E0BC56A36"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF90079FE4B644BE3AFAA2BC8EB144ED8"><enum>(C)</enum><text display-inline="yes-display-inline">assure reasonable consistency with other
relevant directives and with other sentencing guidelines;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7E7B935031DA42678D801349AAF4D8DD"><enum>(D)</enum><text display-inline="yes-display-inline">account for any additional aggravating or
mitigating circumstances that might justify exceptions to the generally
applicable sentencing ranges;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1A27BAEA18B146138C2513AD664BD18F"><enum>(E)</enum><text display-inline="yes-display-inline">make any necessary conforming changes to
the sentencing guidelines; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0F37F6B31E6246869A49A163612BBC00"><enum>(F)</enum><text display-inline="yes-display-inline">assure that the guidelines adequately meet
the purposes of sentencing as set forth in section 3553(a)(2) of title 18,
United States Code.</text>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H73992A4B041F4AA8A964D64B3D0159EA" section-type="subsequent-section"><enum>718.</enum><header display-inline="yes-display-inline">Extraterritorial jurisdiction</header><text display-inline="no-display-inline">Chapter III (21 U.S.C. 331 et seq.) is
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H14FED3CB08624CD19F4BB8ACD029FEED" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H147FA237BCBD47289064C783C3621E7E" section-type="subsequent-section"><enum>311.</enum><header display-inline="yes-display-inline">Extraterritorial jurisdiction</header><text display-inline="no-display-inline">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.</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>VIII</enum><header display-inline="yes-display-inline">Generating Antibiotic Incentives
Now</header>
<section commented="no" display-inline="no-display-inline" id="HF477FB0D8A8F4AD5854219A7E5E9B4D6" section-type="subsequent-section"><enum>801.</enum><header display-inline="yes-display-inline">Extension of exclusivity period for
drugs</header>
<subsection commented="no" display-inline="no-display-inline" id="H3ECF82E095874A73AD3CCC03572ADDFA"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Chapter V (21 U.S.C. 351 et seq.) is
amended by inserting after section 505D the following:</text>
<quoted-block display-inline="no-display-inline" id="H132A0EA6FB064BABAC09555ECFF8EB53" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HB91A3198525A4912A488E5E7A8FE00C8" section-type="subsequent-section"><enum>505E.</enum><header display-inline="yes-display-inline">Extension of exclusivity period for new
qualified infectious disease products</header>
<subsection commented="no" display-inline="no-display-inline" id="H15AE0D2423BA4989A167104E604EE5C9"><enum>(a)</enum><header display-inline="yes-display-inline">Extension</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H20EBBFEC332A4281B6283D5C1BC58D67"><enum>(b)</enum><header display-inline="yes-display-inline">Relation to pediatric
exclusivity</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H16CDFCCF9A8144019C86209380531A2D"><enum>(c)</enum><header display-inline="yes-display-inline">Limitations</header><text display-inline="yes-display-inline">Subsection (a) does not apply to the
approval of—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H4A301B704B1340ACA2C7305489B6DFD8"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H883CE982B67F49579EDE7D6AB2FDFE78"><enum>(2)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0D061E25D74F43AFA06B899F70DFA0B3"><enum>(3)</enum><text display-inline="yes-display-inline">a product that does not meet the definition
of a qualified infectious disease product under subsection (g) based upon its
approved uses.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF045F539402B45D5AA125B5FC5FEC9AF"><enum>(d)</enum><header display-inline="yes-display-inline">Designation</header>
<paragraph commented="no" display-inline="no-display-inline" id="HA52F935BCEAC4D778F2AEAFA4DCB06E2"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H92F354F8BBDC4EA4B8BF1CB0A91960AA"><enum>(2)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6579734E07404FE0BFF55B3F95FDBB91"><enum>(3)</enum><header display-inline="yes-display-inline">Revocation of designation</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H2C870C3C44204AA7A9E6B28F0702F951"><enum>(e)</enum><header display-inline="yes-display-inline">Regulations</header>
<paragraph commented="no" display-inline="no-display-inline" id="HE1F7DDBA49664986AC325BBB1379C0A0"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 2 years after the date of
enactment of the <short-title>Food and Drug Administration
Safety and Innovation Act</short-title>, the Secretary shall adopt final
regulations implementing this section, including developing the list of
qualifying pathogens described in subsection (f).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H857C610E40994F7386438BADBB16CBBC"><enum>(2)</enum><header display-inline="yes-display-inline">Procedure</header><text display-inline="yes-display-inline">In promulgating a regulation implementing
this section, the Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H357246C9835248B1833DC03F44B83E64"><enum>(A)</enum><text display-inline="yes-display-inline">issue a notice of proposed rulemaking that
includes the proposed regulation;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB7733686D3F246A98EB4428BCA375F4B"><enum>(B)</enum><text display-inline="yes-display-inline">provide a period of not less than 60 days
for comments on the proposed regulation; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H04061F001CD745649A7965B7ADB248ED"><enum>(C)</enum><text display-inline="yes-display-inline">publish the final regulation not less than
30 days before the effective date of the regulation.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H67D09C96529D4D9980522FF16A948E95"><enum>(3)</enum><header display-inline="yes-display-inline">Restrictions</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD3E53C0339F2425998F6203AC30316C4"><enum>(4)</enum><header display-inline="yes-display-inline">Designation prior to
regulations</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H41669B1D06F74AE59A39987A43F04661"><enum>(f)</enum><header display-inline="yes-display-inline">Qualifying pathogen</header>
<paragraph commented="no" display-inline="no-display-inline" id="HA0BD746D84874979AE915FF771A2D7F0"><enum>(1)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">In this section, the term <term>qualifying
pathogen</term> 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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H8E3C80678EF3488FB54954DCA4A0C838"><enum>(A)</enum><text display-inline="yes-display-inline">resistant gram positive pathogens,
including methicillin-resistant Staphylococcus aureus, vancomycin-resistant
Staphylococcus aureus, and vancomycin-resistant enterococcus;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2E2411C966C043CBA9B93BD1089127A5"><enum>(B)</enum><text display-inline="yes-display-inline">multi-drug resistant gram negative
bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli
species;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H061B2F32719E4C159B1363C793BD61D6"><enum>(C)</enum><text display-inline="yes-display-inline">multi-drug resistant tuberculosis;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6BC5B50A01DB4B7CBB1664D3B8B409EF"><enum>(D)</enum><text display-inline="yes-display-inline">Clostridium difficile.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE3358BF9DBD445D8A6958F8D446B0E0D"><enum>(2)</enum><header display-inline="yes-display-inline">List of qualifying pathogens</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H87D156066CA541ED9B7ACA16E6C0660F"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall establish and maintain
a list of qualifying pathogens, and shall make public the methodology for
developing such list.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF7A769515ABF42539D53A257BDB4F471"><enum>(B)</enum><header display-inline="yes-display-inline">Considerations</header><text display-inline="yes-display-inline">In establishing and maintaining the list of
pathogens described under this section, the Secretary shall—</text>
<clause commented="no" display-inline="no-display-inline" id="H506187C67F424B5AB87E62D224EBC523"><enum>(i)</enum><text display-inline="yes-display-inline">consider—</text>
<subclause commented="no" display-inline="no-display-inline" id="H3686CD89F0724E41B64187B2E7B0E603"><enum>(I)</enum><text display-inline="yes-display-inline">the impact on the public health due to
drug-resistant organisms in humans;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H94B1DEC259DC43E5907B94D83FCCF0E3"><enum>(II)</enum><text display-inline="yes-display-inline">the rate of growth of drug-resistant
organisms in humans;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H71926E428121457A8645E3DFF6A397E2"><enum>(III)</enum><text display-inline="yes-display-inline">the increase in resistance rates in humans;
and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HED14478F63B14C678014EBA834839DF5"><enum>(IV)</enum><text display-inline="yes-display-inline">the morbidity and mortality in humans;
and</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H95F0FFF738964805B1EB98F5E908FA13"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H22C6EF0448F24C479B859B51730B111B"><enum>(C)</enum><header display-inline="yes-display-inline">Review</header><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HA4DF770F03BC42C68C42D332A3CB0481"><enum>(g)</enum><header display-inline="yes-display-inline">Qualified infectious disease
product</header><text display-inline="yes-display-inline">The term
<term>qualified infectious disease product</term> means an antibacterial or
antifungal drug for human use intended to treat serious or life-threatening
infections, including those caused by—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H8C6A5925C8C2499ABBD1397E9A9E5E8C"><enum>(1)</enum><text display-inline="yes-display-inline">an antibacterial or antifungal resistant
pathogen, including novel or emerging infectious pathogens; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5F5966C66DFB4AF681115A6424C47E91"><enum>(2)</enum><text display-inline="yes-display-inline">qualifying pathogens listed by the
Secretary under subsection
(f).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H98ED77BB3D534C6F84C99E0F6AAF3D65"><enum>(b)</enum><header display-inline="yes-display-inline">Application</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H22FD352B9D3D497893D280CC100A8D3A" section-type="subsequent-section"><enum>802.</enum><header display-inline="yes-display-inline">Priority review</header>
<subsection commented="no" display-inline="no-display-inline" id="H8687BE7EB9C9426E9B9EE2C05A774FFF"><enum>(a)</enum><header display-inline="yes-display-inline">Amendment</header><text display-inline="yes-display-inline">Chapter V (21 U.S.C. 351 et seq.) is
amended by inserting after section 524 the following:</text>
<quoted-block display-inline="no-display-inline" id="H412316F1D6404121B71117141EAD0A8E" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H4564CF41C6264949A875DD184B5A6F77" section-type="subsequent-section"><enum>524A.</enum><header display-inline="yes-display-inline">Priority review for qualified infectious
disease products</header>
<subsection commented="no" display-inline="no-display-inline" id="H2A67DB6EBCD9445ABDF3D9BFA9C26EF5"><enum></enum><text display-inline="yes-display-inline">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).</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H947E2AFC273F4314A3198082D507F2B6"><enum>(b)</enum><header display-inline="yes-display-inline">Application</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HBE2EFB5BD8084E369A4784CFCE0D5C5B" section-type="subsequent-section"><enum>803.</enum><header display-inline="yes-display-inline">Fast track product</header><text display-inline="no-display-inline">Section 506(a)(1) (21 U.S.C. 356(a)(1)), as
amended by section 901(b) of this Act, is amended by inserting <quote>, or if
the Secretary designates the drug as a qualified infectious disease product
under section 505E(d)</quote> before the period at the end of the first
sentence.</text>
</section><section commented="no" display-inline="no-display-inline" id="H46F7A3B62CC14E31B806E10204248D0E" section-type="subsequent-section"><enum>804.</enum><header display-inline="yes-display-inline">Clinical trials</header>
<subsection commented="no" display-inline="no-display-inline" id="H56C5F7A7DCCD455382EA7019AA788414"><enum>(a)</enum><header display-inline="yes-display-inline">Review and revision of guidance
documents</header>
<paragraph commented="no" display-inline="no-display-inline" id="H52D0D1A3DC264C9E944C844FF5C6BC74"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services
(referred to in this section as the <quote>Secretary</quote>) shall review and,
as appropriate, revise not fewer than 3 guidance documents per year, which
shall include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HE0C986BF22034B088750C6409889099B"><enum>(A)</enum><text display-inline="yes-display-inline">reviewing the guidance documents of the
Food and Drug Administration for the conduct of clinical trials with respect to
antibacterial and antifungal drugs; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H353A1EB87B004741A916BAF32BD5EE0D"><enum>(B)</enum><text display-inline="yes-display-inline">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.).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD1219F727E5C492A9E37C3901E89B253"><enum>(2)</enum><header display-inline="yes-display-inline">Issues for review</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDB2F9876475042F39AD52725B802B2BD"><enum>(3)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H36B28A8D24504A76AF6C8F6CC7BB533E"><enum>(b)</enum><header display-inline="yes-display-inline">Recommendations for investigations</header>
<paragraph commented="no" display-inline="no-display-inline" id="HD7D7FBFC2D4D4D79AEAC1BED8F5180ED"><enum>(1)</enum><header display-inline="yes-display-inline">Request</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H61E7F017F28E4A7B95D77F1D42DE0C34"><enum>(2)</enum><header display-inline="yes-display-inline">Recommendations</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF4BBD1B750CB4A7C9692F5ED13C0EC37"><enum>(c)</enum><header display-inline="yes-display-inline">Qualified infectious disease
product</header><text display-inline="yes-display-inline">For purposes of this
section, the term <term>qualified infectious disease product</term> 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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HB8D0902069364D41B1F1937F4AD33471" section-type="subsequent-section"><enum>805.</enum><header display-inline="yes-display-inline">Reassessment of qualified infectious
disease product incentives in 5 years</header>
<subsection commented="no" display-inline="no-display-inline" id="HA660C65259614D738F15B1F3F1D33671"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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:</text>
<paragraph commented="no" display-inline="no-display-inline" id="H9754083B4D3D4B83AC7CE55E63EA1240"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HD600A7F2F0924830B6343A09D5E4F3A5"><enum>(A)</enum><text display-inline="yes-display-inline">The number of initial designations of drugs
as qualified infectious disease products under section 505E of the Federal
Food, Drug, and Cosmetic Act.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3C4EA37756D84836889FC28096B8393A" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">The number of qualified infectious disease
products approved under such section 505E.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H64F74B4F603D4BD7BD69A5ACBEC797D2" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">Whether such products address the need for
antibacterial and antifungal drugs to treat serious and life-threatening
infections.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE3C288D8FBBE470A8D5B0022A2136AFB" indent="up1"><enum>(D)</enum><text display-inline="yes-display-inline">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)).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8927F34B95CB4B3FB5A25B48FA7C9CD7" indent="up1"><enum>(E)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H250D9B95C684427EA9EB554EF92AE558" indent="up1"><enum>(F)</enum><text display-inline="yes-display-inline">The Federal contribution, if any, to
funding of the clinical trials for each qualified infectious disease product
for each phase.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3AAC8D05E7194131A8443BF9B457DFC7"><enum>(2)</enum><text display-inline="yes-display-inline">Recommendations—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H6306B0A1D9034A70BD4137C223D23E98"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6EF2893BCB0549BC8C056F96FDE73C60"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4BC50B5DB16E4B77804A8E380F7E9220"><enum>(3)</enum><text display-inline="yes-display-inline">An examination of—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H76873A1E80354CB8AA5F5E3058997124"><enum>(A)</enum><text display-inline="yes-display-inline">the adoption of programs to measure the use
of antibacterial drugs in health care settings; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6C971FD8AD2E4934B440C427362D9D5B"><enum>(B)</enum><text display-inline="yes-display-inline">the implementation and effectiveness of
antimicrobial stewardship protocols across all health care settings.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6818149B6ECC4CBCB9CA498BA32712E1"><enum>(4)</enum><text display-inline="yes-display-inline">Any recommendations for ways to encourage
further development and establishment of stewardship programs.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H68960DB115C946E681D8F5F14D873C04"><enum>(5)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H536D5391FDFD46A89C6BBFAC490B2619"><enum>(b)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">For purposes of this section, the term
<term>qualified infectious disease product</term> 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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H3F9CA3E3AB744BAE9952F3B73D6C9947" section-type="subsequent-section"><enum>806.</enum><header display-inline="yes-display-inline">Guidance on pathogen-focused antibacterial
drug development</header>
<subsection commented="no" display-inline="no-display-inline" id="H70DAF0ED94E3466383CC3C63D397051C"><enum>(a)</enum><header display-inline="yes-display-inline">Draft
guidance</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H74F4348DEC484956BCF17A7E912D68AE"><enum>(1)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFEE8328042894CE6BC66FA4F7220DC48"><enum>(2)</enum><text display-inline="yes-display-inline">provides advice on approaches for the
development of antibacterial drugs that target a more limited spectrum of
pathogens.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HDE2C11CDA9AF481D9E36EBC6236AD060"><enum>(b)</enum><header display-inline="yes-display-inline">Final
guidance</header><text display-inline="yes-display-inline">Not later than
December 31, 2014, after notice and opportunity for public comment on the draft
guidance under
<internal-xref idref="H70DAF0ED94E3466383CC3C63D397051C" legis-path="__.(a)">subsection (a)</internal-xref>, the Secretary of Health and
Human Services shall publish final guidance consistent with this
section.</text>
</subsection></section><enum>IX</enum><header display-inline="yes-display-inline">Drug approval and patient access</header>
<section commented="no" display-inline="no-display-inline" id="H81C4A715CF7C4C0EBE268CC7A8528AF4" section-type="subsequent-section"><enum>901.</enum><header display-inline="yes-display-inline">Enhancement of accelerated patient access
to new medical treatments</header>
<subsection commented="no" display-inline="no-display-inline" id="H3031D50144AE4E6997D1A14D1158BBBD"><enum>(a)</enum><header display-inline="yes-display-inline">Findings; Sense of Congress</header>
<paragraph commented="no" display-inline="no-display-inline" id="H3BD9571F2CCE44C8BE85CC934DEA12D6"><enum>(1)</enum><header display-inline="yes-display-inline">Findings</header><text display-inline="yes-display-inline">Congress finds as follows:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H658D7FB78BB0491BB62EB35E653035B5"><enum>(A)</enum><text display-inline="yes-display-inline">The Food and Drug Administration (referred
to in this section as the <quote>FDA</quote>) 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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD81AF90D90B24CFEA62B20A0581043A9"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA7A97B050D2C4ED98A814208275A1B69"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2EB37872AC544BCDACFBA287A58D9A68"><enum>(D)</enum><text display-inline="yes-display-inline">Patients benefit from expedited access to
safe and effective innovative therapies to treat unmet medical needs for
serious or life-threatening diseases or conditions.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0A1DF78037ED4A58B70F2AF58B0B6B4E"><enum>(E)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA79C58A50FE9409A95660E2E9869C337"><enum>(2)</enum><header display-inline="yes-display-inline">Sense of Congress</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H11CEF5EDC6F941338107F7F52033A42A"><enum>(b)</enum><header display-inline="yes-display-inline">Expedited approval of drugs for serious or
life-Threatening diseases or conditions</header><text display-inline="yes-display-inline">Section 506 (21 U.S.C. 356) is amended to
read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HF859EBA8A1A74424AF5845E0FE75DD34" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H8B777AC72F0E4E4280F8C5E795B8C09E" section-type="subsequent-section"><enum>506.</enum><header display-inline="yes-display-inline">Expedited approval of drugs for serious or
life-threatening diseases or conditions</header>
<subsection commented="no" display-inline="no-display-inline" id="HBE4290653F3448DA9979D75F9CB56FF0"><enum>(a)</enum><header display-inline="yes-display-inline">Designation of drug as fast track
product</header>
<paragraph commented="no" display-inline="no-display-inline" id="HD87C0D83A5AB4E03B0479C40C1ABB042"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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
<quote>fast track product</quote>.)</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H450DBC86B7E545899A84EB5215179A53"><enum>(2)</enum><header display-inline="yes-display-inline">Request for designation</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4E802E3FB8914818BEB8253F2FB33483"><enum>(3)</enum><header display-inline="yes-display-inline">Designation</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H8A0A38562EC440A985713F4A5F129D2C"><enum>(b)</enum><header display-inline="yes-display-inline">Accelerated approval of a drug for a
serious or life-Threatening disease or condition, including a fast track
product</header>
<paragraph commented="no" display-inline="no-display-inline" id="H0199BE6744674291AA9473A115BA3F70"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HC1DC2B1041D9415FBB61F9498E372223"><enum>(A)</enum><header display-inline="yes-display-inline">Accelerated approval</header><text display-inline="yes-display-inline">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 <quote>accelerated
approval</quote>.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5DDCFBA311F64CC18E85897AF06E0C99"><enum>(B)</enum><header display-inline="yes-display-inline">Evidence</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD09AB1933889454D9A56638EC040370B"><enum>(2)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Approval of a product under this subsection
may be subject to 1 or both of the following requirements:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H938FB497FB3A49708A100DAD268DCD42"><enum>(A)</enum><text display-inline="yes-display-inline">That the sponsor conduct appropriate
postapproval studies to verify and describe the predicted effect on
irreversible morbidity or mortality or other clinical benefit.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2728DF7913054A53A6D3FAF3C74AC5F1"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD4710EB017A04956AFD32CF70D5F693C"><enum>(3)</enum><header display-inline="yes-display-inline">Expedited withdrawal of
approval</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HE9820B0DCAF64F20BF8C881FD9CDE8C0"><enum>(A)</enum><text display-inline="yes-display-inline">the sponsor fails to conduct any required
postapproval study of the drug with due diligence;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H69CF1339CC9E4625BEAC48BE82206F47"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEFFAA12DACFD4EA48B69B44B64E1F031"><enum>(C)</enum><text display-inline="yes-display-inline">other evidence demonstrates that the
product is not safe or effective under the conditions of use; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8E99F71D771D4B70A83A0DFDC2487434"><enum>(D)</enum><text display-inline="yes-display-inline">the sponsor disseminates false or
misleading promotional materials with respect to the product.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H36C5C57049CF4CC396E1541DB5A886B9"><enum>(c)</enum><header display-inline="yes-display-inline">Review of incomplete applications for
approval of a fast track product</header>
<paragraph commented="no" display-inline="no-display-inline" id="H978140FB34AC4EF3BB0ADAE633029A91"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H869CD1B770C94107A21B78A340C7767B"><enum>(A)</enum><text display-inline="yes-display-inline">provides a schedule for submission of
information necessary to make the application complete; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8F378B43798C40F68F65B1DEF0CA9CD5"><enum>(B)</enum><text display-inline="yes-display-inline">pays any fee that may be required under
section 736.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H615B9C06564F479C9EBB162552246711"><enum>(2)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H0B06F9B91C0A4CCE8434F51BDCD086D9"><enum>(d)</enum><header display-inline="yes-display-inline">Awareness efforts</header><text display-inline="yes-display-inline">The Secretary shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HDFCAF84435C142B0A3E029321B5BED77"><enum>(1)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBC9B667E7D6647A6A22E0547C4F50FEA"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H0CE4D0F9FCF34D87938F50B9E9276D82"><enum>(e)</enum><header display-inline="yes-display-inline">Construction</header>
<paragraph commented="no" display-inline="no-display-inline" id="H3FAE2438F9D74DF58BCADDA790C5B86B"><enum>(1)</enum><header display-inline="yes-display-inline">Purpose</header><text display-inline="yes-display-inline">The amendments made by the
<short-title>Food and Drug Administration Safety and
Innovation Act</short-title> 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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9BCC87120C304299AD431BF4E2025550"><enum>(2)</enum><header display-inline="yes-display-inline">Construction</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HCAFEAEAD8D864019B686B6D6D463854F"><enum>(c)</enum><header display-inline="yes-display-inline">Guidance; amended regulations</header>
<paragraph commented="no" display-inline="no-display-inline" id="HF2128E3FBCED4D41B497E19FF8ABE370"><enum>(1)</enum><header display-inline="yes-display-inline">Draft
guidance</header><text display-inline="yes-display-inline">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 <quote>Secretary</quote>) 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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H11BEFF9A04414AA993D1C5A1B5B1A213"><enum>(2)</enum><header display-inline="yes-display-inline">Final
guidance</header><text display-inline="yes-display-inline">Not later than 1
year after the issuance of draft guidance under paragraph (1), and after an
opportunity for public comment, the Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H39E0628C8D624497A09D380EC100C218"><enum>(A)</enum><text display-inline="yes-display-inline">issue final guidance; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3B251E2D9E3148C6808C28F7B6B576B9"><enum>(B)</enum><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H05027D83C6784F4EA44C55DE4CF39382"><enum>(3)</enum><header display-inline="yes-display-inline">Consideration</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBFD25A0E2BDC4FAA92B640474E95B726"><enum>(4)</enum><header display-inline="yes-display-inline">Conforming changes</header><text display-inline="yes-display-inline">The Secretary shall issue, as necessary,
conforming amendments to the applicable regulations under title 21, Code of
Federal Regulations, governing accelerated approval.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF59978E294774D19AA74FB67467F5344"><enum>(5)</enum><header display-inline="yes-display-inline">No effect of inaction on
requests</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HA3B69F4B9AB8479CBC4959C2130C2076"><enum>(d)</enum><header display-inline="yes-display-inline">Independent review</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HBD1848D627FA4FA193343808585EFEF7" section-type="subsequent-section"><enum>902.</enum><header display-inline="yes-display-inline">Breakthrough therapies</header>
<subsection commented="no" display-inline="no-display-inline" id="HA95846067E024B6C8DCF0B57237328F8"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 506 (21 U.S.C. 356), as amended by
section 901 of this Act, is further amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H9EA09E1A2F604B97875B2FB7FB17B2CC"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating subsections (a) through
(c) as subsections (b) through (d), respectively;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE3DA959BB086486F9811E736D7E8F34D"><enum>(2)</enum><text display-inline="yes-display-inline">by redesignating subsection (d) as
subsection (f);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7D841D9113D94597B062DA335D14D41F"><enum>(3)</enum><text display-inline="yes-display-inline">by inserting before subsection (b), as so
redesignated, the following:</text>
<quoted-block display-inline="no-display-inline" id="H718A7A0793B84874A7B021ADE8BAC15E" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HA681FC01164F431881C0710D3F86BDB0"><enum>(a)</enum><header display-inline="yes-display-inline">Designation of a drug as a breakthrough
therapy</header>
<paragraph commented="no" display-inline="no-display-inline" id="HAD22566A4C6B40BF9141FF029B6B5E83"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 <term>breakthrough
therapy</term>.)</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEEA97288146A48FBA096F97C26BA6C50"><enum>(2)</enum><header display-inline="yes-display-inline">Request for designation</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7978E4BC28C543BEBB402A20B22B1E10"><enum>(3)</enum><header display-inline="yes-display-inline">Designation</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H328268ADB45C43F4A03ADAF04FFC7571"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6E898E119C2941689624329F3C11AEAC"><enum>(B)</enum><header display-inline="yes-display-inline">Actions</header><text display-inline="yes-display-inline">The actions to expedite the development and
review of an application under subparagraph (A) may include, as
appropriate—</text>
<clause commented="no" display-inline="no-display-inline" id="H91C0AE54A03048D6AFA3B142E98AD557"><enum>(i)</enum><text display-inline="yes-display-inline">holding meetings with the sponsor and the
review team throughout the development of the drug;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H9EE14B3A8B7F46DEB3A3C38134B8BC03"><enum>(ii)</enum><text display-inline="yes-display-inline">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;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H71B116DD6777476988528944C59766B4"><enum>(iii)</enum><text display-inline="yes-display-inline">involving senior managers and experienced
review staff, as appropriate, in a collaborative, cross-disciplinary
review;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H03B37EE21C4A4165AB87962CB37A0CB4"><enum>(iv)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HAEF6A5C071DF468099BD19BB1DB5A3D0"><enum>(v)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph></paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6E3E008611394C4590BBFB9AA55A3A0F"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (f)(1), as so redesignated,
by striking <quote>applicable to accelerated approval</quote> and inserting
<quote>applicable to breakthrough therapies, accelerated approval,
and</quote>.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HD349EF1C438C4A89AA4D695A432D21C5"><enum>(b)</enum><header display-inline="yes-display-inline">Guidance; amended regulations</header>
<paragraph commented="no" display-inline="no-display-inline" id="H54298FC846F742FEA79624C9E5A08177"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HD46CD762E888426399BD5D3B8AA9E5AA"><enum>(A)</enum><header display-inline="yes-display-inline">Guidance</header><text display-inline="yes-display-inline">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 <quote>Secretary</quote>) 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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB5B8710A22584BFF8200756BA6E1B00E"><enum>(B)</enum><header display-inline="yes-display-inline">Amended regulations</header>
<clause commented="no" display-inline="no-display-inline" id="H0BA0539524C34219B91B3B72D511A294"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H0E86615F1649487E9932EB98CAB49358"><enum>(ii)</enum><header display-inline="yes-display-inline">Procedure</header><text display-inline="yes-display-inline">In amending regulations under clause (i),
the Secretary shall—</text>
<subclause commented="no" display-inline="no-display-inline" id="H8B99EB82BBBB442D83A765C2F00C29BB"><enum>(I)</enum><text display-inline="yes-display-inline">issue a notice of proposed rulemaking that
includes the proposed regulation;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HCDB30D4CC6AE4F12AB66C57DAC91FBAA"><enum>(II)</enum><text display-inline="yes-display-inline">provide a period of not less than 60 days
for comments on the proposed regulation; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H1000B922D7324AB5A06BBB439B2DF17A"><enum>(III)</enum><text display-inline="yes-display-inline">publish the final regulation not less than
30 days before the effective date of the regulation.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="HA9924916E00C4708B70AEF98AF1133BB"><enum>(iii)</enum><header display-inline="yes-display-inline">Restrictions</header><text display-inline="yes-display-inline">Notwithstanding any other provision of law,
the Secretary shall promulgate regulations implementing the amendments made by
this section only as described in clause (ii).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H320EF5F5C0164736A53D028D0D968134"><enum>(2)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">Guidance issued under this section
shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HBCCDAF24DFDD4E28BF97F9FBBB797726"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAE84C142CC044F5E832F2317DA438B81"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HB89EF7B2E9FC46A0B81C46B6661E5078"><enum>(c)</enum><header display-inline="yes-display-inline">Conforming amendments</header><text display-inline="yes-display-inline">Section 506B(e) (21 U.S.C. 356b) is amended
by striking <quote>section 506(b)(2)(A)</quote> each place such term appears
and inserting <quote>section 506(c)(2)(A)</quote>.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H70BFE7797114402FB3D91D8E750C981B" section-type="subsequent-section"><enum>903.</enum><header display-inline="yes-display-inline">Consultation with external experts on rare
diseases, targeted therapies, and genetic targeting of treatments</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="H57F7BCC8DC6941C6AC12A9476DA9A599" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H276C407C62F54F21A01C6DEBCEF04555" section-type="subsequent-section"><enum>569.</enum><header display-inline="yes-display-inline">Consultation with external experts on rare
diseases, targeted therapies, and genetic targeting of treatments</header>
<subsection commented="no" display-inline="no-display-inline" id="H50A9763D3AE147EB9188E3D640046A4C"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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:</text>
<paragraph commented="no" display-inline="no-display-inline" id="H54D8CB2B4C3646A9B35A9FDF9343BC67"><enum>(1)</enum><header display-inline="yes-display-inline">Consultation with
stakeholders</header><text display-inline="yes-display-inline">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).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5B65FF4774C848BFA109BDC0906BB20A"><enum>(2)</enum><header display-inline="yes-display-inline">Consultation with external experts</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HE0D628636554445BB01530DBF81725F8"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H516D7202477E402090129541B4038E1D"><enum>(B)</enum><header display-inline="yes-display-inline">External experts</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HDC97706239AE478D97BD80AAF3EEB61F"><enum>(b)</enum><header display-inline="yes-display-inline">Topics for consultation</header><text display-inline="yes-display-inline">Topics for consultation pursuant to this
section may include—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H73217AAE3D1A47F6A02B888BAB946D13"><enum>(1)</enum><text display-inline="yes-display-inline">rare diseases;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H85310180F24A438FAE6CC43C7A8D9C7B"><enum>(2)</enum><text display-inline="yes-display-inline">the severity of rare diseases;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE1B55684F11043B794BE07CCF3A83C98"><enum>(3)</enum><text display-inline="yes-display-inline">the unmet medical need associated with rare
diseases;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF5A221CD9D5E458095CFBA8066280074"><enum>(4)</enum><text display-inline="yes-display-inline">the willingness and ability of individuals
with a rare disease to participate in clinical trials;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H57512D1EAB9F44B88127678D816B75A3"><enum>(5)</enum><text display-inline="yes-display-inline">an assessment of the benefits and risks of
therapies to treat rare diseases;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7D9AAC0F57F94DABB724F354D866E00A"><enum>(6)</enum><text display-inline="yes-display-inline">the general design of clinical trials for
rare disease populations and subpopulations; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0779E20DBF00435CB3088C926EB99892"><enum>(7)</enum><text display-inline="yes-display-inline">the demographics and the clinical
description of patient populations.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HAAC50C8240CE47E6B162BE1EDE53A25A"><enum>(c)</enum><header display-inline="yes-display-inline">Classification as special government
employees</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HAC346A8D23D447AEBEA5163CCE2C2024"><enum>(d)</enum><header display-inline="yes-display-inline">Protection of confidential information and
trade secrets</header>
<paragraph commented="no" display-inline="no-display-inline" id="HD3F7A2E794F74BB189BDC88F05BBEB47"><enum>(1)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HED5822D0D305422D812694F21125FB46"><enum>(2)</enum><header display-inline="yes-display-inline">Consent required for
disclosure</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HAD6D63F5B29740CA9165D799163CBD51"><enum>(e)</enum><header display-inline="yes-display-inline">Other consultation</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H43D1E374EE70420498B7890CC2A38E20"><enum>(f)</enum><header display-inline="yes-display-inline">No right or obligation</header>
<paragraph commented="no" display-inline="no-display-inline" id="H49653A602E72431BA23A8AFCC46D5C37"><enum>(1)</enum><header display-inline="yes-display-inline">No right to consultation</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBE8155CEBE764D12B04C21692F6F2085"><enum>(2)</enum><header display-inline="yes-display-inline">No altering of goals</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDFE0486C1107458D8BD773B4CDB4E044"><enum>(3)</enum><header display-inline="yes-display-inline">No change to number of review
cycles</header><text display-inline="yes-display-inline">Nothing in this
section is intended to increase the number of review cycles as in effect before
the date of enactment of this section.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H5191F785D2FD4234BC4C1349265DA16A"><enum>(g)</enum><header display-inline="yes-display-inline">No delay in product review</header>
<paragraph commented="no" display-inline="no-display-inline" id="HE529E20C06294664AB8D743348AD0E85"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H7ADE468278AB46089CEC649877162FBF"><enum>(A)</enum><text display-inline="yes-display-inline">such consultation will—</text>
<clause commented="no" display-inline="no-display-inline" id="HF6E0B7CA78C04CFFB8B1254E4FF8304E"><enum>(i)</enum><text display-inline="yes-display-inline">facilitate the Secretary’s ability to
complete the Secretary’s review; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H6DA0DA16F650491AA55739A6C8F4E16A"><enum>(ii)</enum><text display-inline="yes-display-inline">address outstanding deficiencies in the
application; or</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2C6FCA46ACA34538972595465A472FFE"><enum>(B)</enum><text display-inline="yes-display-inline">the sponsor authorized such
consultation.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB6972533E2874E0BA40D07208C63101C"><enum>(2)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H48A3B2F3FF8B4049891E5B869B9697B7" section-type="subsequent-section"><enum>904.</enum><header display-inline="yes-display-inline">Accessibility of information on
prescription drug container labels by visually impaired and blind
consumers</header>
<subsection commented="no" display-inline="no-display-inline" id="H999A2E839E884BFD8FC9741D26F3E280"><enum>(a)</enum><header display-inline="yes-display-inline">Establishment of Working Group</header>
<paragraph commented="no" display-inline="no-display-inline" id="H52AE1A1061C64AEBABBF3B6A67F0D4DA"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Architectural and Transportation
Barriers Compliance Board (referred to in this section as the <quote>Access
Board</quote>) shall convene a stakeholder working group (referred to in this
section as the <quote>working group</quote>) to develop best practices on
access to information on prescription drug container labels for individuals who
are blind or visually impaired.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H18217F0F32ED42099C07013CB4C4199D"><enum>(2)</enum><header display-inline="yes-display-inline">Members</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H53EFB853112445C7AD7B421EAAB82DC3"><enum>(3)</enum><header display-inline="yes-display-inline">Best practices</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H045BBAA274074C4BBCDC499F022F7C9E"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H851F4A27458543A29948C2AD5C6CC74A"><enum>(B)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6E56EB2528834715957F512F6869C8B5"><enum>(C)</enum><header display-inline="yes-display-inline">Limitations</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBF126CFF045040C4A01C21E9A4C6FED0"><enum>(4)</enum><header display-inline="yes-display-inline">Considerations</header><text display-inline="yes-display-inline">In developing and issuing the best
practices under paragraph (3)(A), the working group shall consider—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HE80A10C17E5345AC87FCCA96553F9136"><enum>(A)</enum><text display-inline="yes-display-inline">the use of—</text>
<clause commented="no" display-inline="no-display-inline" id="HE0E9F4AD63EC458EACA632E35EA99615"><enum>(i)</enum><text display-inline="yes-display-inline">Braille;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H24AC1C6780694A1C974114B5643A55FE"><enum>(ii)</enum><text display-inline="yes-display-inline">auditory means, such as—</text>
<subclause commented="no" display-inline="no-display-inline" id="HBA77EA1121BB4DB6BD4302FE52D41801"><enum>(I)</enum><text display-inline="yes-display-inline"><quote>talking bottles</quote> that provide
audible container label information;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HF425324C98A64D11B94F7436A1E5194D"><enum>(II)</enum><text display-inline="yes-display-inline">digital voice recorders attached to the
prescription drug container; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HF97F0C6B870B42C195D87E9ACC9E7428"><enum>(III)</enum><text display-inline="yes-display-inline">radio frequency identification tags;</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H7E0D8625324F4B119A1CFCCDA67FFBF0"><enum>(iii)</enum><text display-inline="yes-display-inline">enhanced visual means, such as—</text>
<subclause commented="no" display-inline="no-display-inline" id="HE75C901A40134C3383A4B006CF640203"><enum>(I)</enum><text display-inline="yes-display-inline">large font labels or large font
<quote>duplicate</quote> labels that are affixed or matched to a prescription
drug container;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HECC79FF2FDC1413BBB6879314BF55EEC"><enum>(II)</enum><text display-inline="yes-display-inline">high-contrast printing; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H510ADB078F2F435C924C37459ED6EC00"><enum>(III)</enum><text display-inline="yes-display-inline">sans-serif font; and</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H11DB03083F1040798EBDB6771BE3A8F1"><enum>(iv)</enum><text display-inline="yes-display-inline">other relevant alternatives as determined
by the working group;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD0DA543F7F4D484A9F2359E04050D637"><enum>(B)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H240DCF3B8B1E4BFABBF19ECFD7D5CB37"><enum>(C)</enum><text display-inline="yes-display-inline">such other factors as the working group
determines to be appropriate.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEF63244760CB4BE88545927C64DB4FD3"><enum>(5)</enum><header display-inline="yes-display-inline">Information campaign</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H53B689F25685424B95CCA3FBEFC573B9"><enum>(6)</enum><header display-inline="yes-display-inline">FACA waiver</header><text display-inline="yes-display-inline">The Federal Advisory Committee Act (5
U.S.C. App.) shall not apply to the working group.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HC23915AFF5484B81A9B9A3B4AF95CAD3"><enum>(b)</enum><header display-inline="yes-display-inline">GAO Study</header>
<paragraph commented="no" display-inline="no-display-inline" id="H9F4C583F76BB42ECAF3BD8645028E913"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3BCB03E9189B48A9B9849D0F89A42E1B"><enum>(2)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HC64135539D694E339930D857B9381EB6"><enum>(c)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this section—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HAC9F871727854430B783A96809A74B8C"><enum>(1)</enum><text display-inline="yes-display-inline">the term <term>pharmacy</term> includes a
pharmacy that receives prescriptions and dispenses prescription drugs through
an Internet Web site or by mail;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H28512FD7EC34477F84EB78F29179B8DA"><enum>(2)</enum><text display-inline="yes-display-inline">the term <term>prescription drug</term>
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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5794F77DE4A8438EA118CCC48A873157"><enum>(3)</enum><text display-inline="yes-display-inline">the term <term>prescription drug container
label</term> means the label with the directions for use that is affixed to the
prescription drug container by the pharmacist and dispensed to the
consumer.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="HA33828B7A56440EA803F8BC19C97BC56" section-type="subsequent-section"><enum>905.</enum><header display-inline="yes-display-inline">Risk-benefit framework</header><text display-inline="no-display-inline">Section 505(d) (21 U.S.C. 355(d)) is amended
by adding at the end the following: <quote>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.</quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="HD062CB639ED7437DB41880FE72D22810" section-type="subsequent-section"><enum>906.</enum><header display-inline="yes-display-inline">Grants and Contracts for the Development of
Orphan Drugs</header>
<subsection commented="no" display-inline="no-display-inline" id="H6E67E4EB55084698A30887E0D547C916"><enum>(a)</enum><header display-inline="yes-display-inline">Qualified testing definition</header><text display-inline="yes-display-inline">Section 5(b)(1)(A)(ii) of the Orphan Drug
Act (21 U.S.C. 360ee(b)(1)(A)(ii)) is amended by striking <quote>after the date
such drug is designated under section 526 of such Act and</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HF4F729F032534B7D9F8A09D9D3796A87"><enum>(b)</enum><header display-inline="yes-display-inline">Authorization of
Appropriations</header><text display-inline="yes-display-inline">Section 5(c)
of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="HE584AC3A23374C1298D2E32588D94255" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H0FC90292BC4940E5859B094EFFA28610"><enum>(c)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">For grants and
contracts under subsection (a), there is authorized to be appropriated
$30,000,000 for each of fiscal years 2013 through
2017.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H04EEF7BBFDC94D989A5C4D20877EF082" section-type="subsequent-section"><enum>907.</enum><header display-inline="yes-display-inline">Reporting of inclusion of demographic
subgroups in clinical trials and data analysis in applications for drugs,
biologics, and devices</header>
<subsection commented="no" display-inline="no-display-inline" id="H561D2A51188A4E7F89B8BFB3C8E37826"><enum>(a)</enum><header display-inline="yes-display-inline">Report</header>
<paragraph commented="no" display-inline="no-display-inline" id="H28D5BE1293544F22A13DE4506DFE30B6"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H580C7CDF85B345E7A2A2CBE44837C68E"><enum>(2)</enum><header display-inline="yes-display-inline">Contents of report</header><text display-inline="yes-display-inline">The report described in paragraph (1) shall
contain the following:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H51BB2BADF2C94C57A12D4B8ABF0F1542"><enum>(A)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC2DC1425D72246059E0C70A9091F7B06"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H02B77FCD549D4EB2B24CBDE43041D9B3"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6B3A49CF4470409EA1E30FD1BE4F5592"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H1B00B72A001548DBB7EC791D7D937059"><enum>(b)</enum><header display-inline="yes-display-inline">Action plan</header>
<paragraph commented="no" display-inline="no-display-inline" id="HD08141DDDED34144ADE750BB5EEEF14E"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6F8CF692256A4DA9BF472E69A2AECC65"><enum>(2)</enum><header display-inline="yes-display-inline">Content of action plan</header><text display-inline="yes-display-inline">The plan described in paragraph (1) shall
include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H8D1499298EAC4F85B626B9041023A113"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF41362ECEDB44C4E828E90B09C9010F8"><enum>(B)</enum><text display-inline="yes-display-inline">recommendations, as appropriate, on the
inclusion of such data, or the lack of availability of such data in
labeling;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H015C37DBBA7C41C38393ABCD2E30536D"><enum>(C)</enum><text display-inline="yes-display-inline">recommendations, as appropriate, to
otherwise improve the public availability of such data to patients, health care
providers, and researchers; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAAF64FD3649A4CDE901A894C553076F4"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H5E3FC16F7563410D86DAA6EF1C541FC5"><enum>(c)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this section:</text>
<paragraph commented="no" display-inline="no-display-inline" id="HA2722934A9D34555967999F045EB0452"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>Commissioner</term> means
the Commissioner of Food and Drugs.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H24278D462F7C4ED797F903929E594D5C"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>device</term> has the
meaning given such term in section 201(h) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(h)).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD18D2FB672814B81B24D157AB7ED990F"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>drug</term> has the meaning
given such term in section 201(g) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(g)).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H56976DB50A3B48EC87D32BC38E2886D9"><enum>(4)</enum><text display-inline="yes-display-inline">The term <term>biological product</term>
has the meaning given such term in section 351(i) of the Public Health Service
Act (42 U.S.C. 262(i)).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H95B775F06E7C4717AE5B086DAC720062"><enum>(5)</enum><text display-inline="yes-display-inline">The term <term>Secretary</term> means the
Secretary of Health and Human Services.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H3DD600133E0D41EFA98A65AF83109F46" section-type="subsequent-section"><enum>908.</enum><header display-inline="yes-display-inline">Rare pediatric disease priority review
voucher incentive program</header><text display-inline="no-display-inline">Subchapter B of chapter V (21 U.S.C. 360aa
et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H5D2B604F56564FF0A95921492626BCDB" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H62CDD76E824742729E932AB66219C632" section-type="subsequent-section"><enum>529.</enum><header display-inline="yes-display-inline">Priority review to encourage treatments for
rare pediatric diseases</header>
<subsection commented="no" display-inline="no-display-inline" id="H84C763A010FA49B5BF8E6F4375F5F107"><enum>(a)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this section:</text>
<paragraph commented="no" display-inline="no-display-inline" id="HD236D6EF1BCE42EF81B6FE64429F7320"><enum>(1)</enum><header display-inline="yes-display-inline">Priority review</header><text display-inline="yes-display-inline">The term <term>priority review</term>, 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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H146A7027CC6841A59F3FFD71CAC6B86C"><enum>(2)</enum><header display-inline="yes-display-inline">Priority review voucher</header><text display-inline="yes-display-inline">The term <term>priority review
voucher</term> 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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H16369824FA784D899826BF489CCE28DA"><enum>(3)</enum><header display-inline="yes-display-inline">Rare pediatric disease</header><text display-inline="yes-display-inline">The term <term>rare pediatric
disease</term> means a disease that meets each of the following
criteria:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HB210CE53BB26435D80BF146075163E95"><enum>(A)</enum><text display-inline="yes-display-inline">The disease primarily affects individuals
aged from birth to 18 years, including age groups often called neonates,
infants, children, and adolescents.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB37F243016664E61BF4D4CE0CF818A46"><enum>(B)</enum><text display-inline="yes-display-inline">The disease is a rare disease or condition,
within the meaning of section 526.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE3A2C2DCF8CA40F7B2529AB4E9D1C94D"><enum>(4)</enum><header display-inline="yes-display-inline">Rare pediatric disease product
application</header><text display-inline="yes-display-inline">The term
<term>rare pediatric disease product application</term> means a human drug
application, as defined in section 735(1), that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HD39F7D98898C485BB91FEDD2EE6ABC22"><enum>(A)</enum><text display-inline="yes-display-inline">is for a drug or biological product—</text>
<clause commented="no" display-inline="no-display-inline" id="HCB203EF5292F4550BFC4B2BDEF304959"><enum>(i)</enum><text display-inline="yes-display-inline">that is for the prevention or treatment of
a rare pediatric disease; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HC2095034A4E04979BEE6357ED6493D0C"><enum>(ii)</enum><text display-inline="yes-display-inline">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;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H86497EAA267743ECAF172DEB0923C6D7"><enum>(B)</enum><text display-inline="yes-display-inline">is submitted under section 505(b)(1) of
this Act or section 351(a) of the Public Health Service Act;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0467E6C8B54142B8834F52DD6B268052"><enum>(C)</enum><text display-inline="yes-display-inline">the Secretary deems eligible for priority
review;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC25FDB52F63A4E2AA140DD435115F65E"><enum>(D)</enum><text display-inline="yes-display-inline">that relies on clinical data derived from
studies examining a pediatric population and dosages of the drug intended for
that population;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA492471B425641458085C9E8476099C3"><enum>(E)</enum><text display-inline="yes-display-inline">that does not seek approval for an adult
indication in the original rare pediatric disease product application;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6F0CF00C629749A28DFDE1467C6A9091"><enum>(F)</enum><text display-inline="yes-display-inline">is approved after the date of the enactment
of the Prescription Drug User Fee Amendments of 2012.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H406C4B8B7113427BA129686B236B7B08"><enum>(b)</enum><header display-inline="yes-display-inline">Priority Review Voucher</header>
<paragraph commented="no" display-inline="no-display-inline" id="HF6D5CD2DB22A4E57ACA32E08A68C3AD1"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB97B91A4EF4F4326B9F3F07A2C1A490F"><enum>(2)</enum><header display-inline="yes-display-inline">Transferability</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H351FF20F48EC492E80645E40A9B20CC4"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2D9AAA047C3046A6B655A807B2AF053C"><enum>(B)</enum><header display-inline="yes-display-inline">Notification of transfer</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4621731803B84F9D9A98A6B3FE8638CE"><enum>(3)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFB1C6A2EDEF64B24BAD93CE92EA9CDA3"><enum>(4)</enum><header display-inline="yes-display-inline">Notification</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H235B0EC3614C495E9F5B9C82AAF50D27"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8317AAF1968B4416BF1D8DB268050747"><enum>(B)</enum><header display-inline="yes-display-inline">Transfer after notice</header><text display-inline="yes-display-inline">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
<internal-xref idref="H235B0EC3614C495E9F5B9C82AAF50D27" legis-path="529.(b)(4)(A)">subparagraph (A)</internal-xref> may transfer the
voucher after such notification is provided, if such sponsor has not yet
submitted the human drug application described in the notification.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3C8BFE4AD05F43438F5BAB34C54C2439"><enum>(5)</enum><header display-inline="yes-display-inline">Termination of authority</header><text display-inline="yes-display-inline">The Secretary may not award any priority
review vouchers under
<internal-xref idref="HF6D5CD2DB22A4E57ACA32E08A68C3AD1" legis-path="529.(b)(1)">paragraph (1)</internal-xref> 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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H74E861F6D308433F9C2D3A73E13C5D6A"><enum>(c)</enum><header display-inline="yes-display-inline">Priority Review User Fee</header>
<paragraph commented="no" display-inline="no-display-inline" id="H09081E3F08344D718884FB6132E418E0"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H12B735A2F2224AA6B1D194CFD7C6E25B"><enum>(2)</enum><header display-inline="yes-display-inline">Fee amount</header><text display-inline="yes-display-inline">The amount of the priority review user fee
shall be determined each fiscal year by the Secretary, based on the difference
between—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HE8606C887F254C1F99D8F046DF98D1C9"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF6AB15C4531E4F2E9E3C8DE66F155583"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC9305F1AC30643789FFC0041472F85BD"><enum>(3)</enum><header display-inline="yes-display-inline">Annual fee setting</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1BF3165BBEF549649B8D6A54784A3307"><enum>(4)</enum><header display-inline="yes-display-inline">Payment</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H06A66FB656B84E6499C2B94CDA6D7AF2"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8C371123746A4606BF0F55ACD7A3AAAD"><enum>(B)</enum><header display-inline="yes-display-inline">Complete application</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5C419E5E95BD41408C6674939318F647"><enum>(C)</enum><header display-inline="yes-display-inline">No waivers, exemptions, reductions, or
refunds</header><text display-inline="yes-display-inline">The Secretary may not
grant a waiver, exemption, reduction, or refund of any fees due and payable
under this section.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HCF1DF604FCD847BF87FC4816892FDE0D"><enum>(5)</enum><header display-inline="yes-display-inline">Offsetting collections</header><text display-inline="yes-display-inline">Fees collected pursuant to this subsection
for any fiscal year—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H4E37D058A5A64A61AC3AAC2420516EF1"><enum>(A)</enum><text display-inline="yes-display-inline">shall be deposited and credited as
offsetting collections to the account providing appropriations to the Food and
Drug Administration; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2B851A0E8C8443F8889DC43C2256F48B"><enum>(B)</enum><text display-inline="yes-display-inline">shall not be collected for any fiscal year
except to the extent provided in advance in appropriations Acts.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF42FF67EE6B1459F8AA0D98A6ACA1718"><enum>(d)</enum><header display-inline="yes-display-inline">Designation process</header>
<paragraph commented="no" display-inline="no-display-inline" id="H1373F0B7CC7F415BADAF0F41BB68C125"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Upon the request of the manufacturer or the
sponsor of a new drug, the Secretary may designate—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H1093197B3A0E4BCB9ADD819BD5404665"><enum>(A)</enum><text display-inline="yes-display-inline">the new drug as a drug for a rare pediatric
disease; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA8811B5397AD4FDE920B01E2310BCFDE"><enum>(B)</enum><text display-inline="yes-display-inline">the application for the new drug as a rare
pediatric disease product application.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1C529239FBE441709D6D5BFAAEF27FBC"><enum>(2)</enum><header display-inline="yes-display-inline">Request for designation</header><text display-inline="yes-display-inline">The request for a designation under
<internal-xref idref="H1373F0B7CC7F415BADAF0F41BB68C125" legis-path="529.(d)(1)">paragraph (1)</internal-xref> 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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H34FB2B36AECA482C8D3857E9EF5D22E0"><enum>(3)</enum><header display-inline="yes-display-inline">Determination by Secretary</header><text display-inline="yes-display-inline">Not later than 60 days after a request is
submitted under
<internal-xref idref="H1373F0B7CC7F415BADAF0F41BB68C125" legis-path="529.(d)(1)">paragraph (1)</internal-xref>, the Secretary shall
determine whether—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HCB50AA19D2D94FC3842A5C16B72E37EB"><enum>(A)</enum><text display-inline="yes-display-inline">the disease or condition that is the
subject of such request is a rare pediatric disease; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0E3729CE630741B5A778354C2E113876"><enum>(B)</enum><text display-inline="yes-display-inline">the application for the new drug is a rare
pediatric disease product application.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H305C09DBF4774CFE819D6883D988625A"><enum>(e)</enum><header display-inline="yes-display-inline">Marketing of rare pediatric disease
products</header>
<paragraph commented="no" display-inline="no-display-inline" id="H79E94B48C79B49DDAACA169332025E5B"><enum>(1)</enum><header display-inline="yes-display-inline">Revocation</header><text display-inline="yes-display-inline">The Secretary may revoke any priority
review voucher awarded under
<internal-xref idref="H406C4B8B7113427BA129686B236B7B08" legis-path="529.(b)">subsection (b)</internal-xref> 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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3A445F7502034FBFBFAF5600C732FBEA"><enum>(2)</enum><header display-inline="yes-display-inline">Postapproval production
report</header><text display-inline="yes-display-inline">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:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HEB0E1D5F2D174AA5B6874AC42B59D977"><enum>(A)</enum><text display-inline="yes-display-inline">The estimated population in the United
States suffering from the rare pediatric disease.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H596AC95B8A204F2EB3D92B70AC6196AB"><enum>(B)</enum><text display-inline="yes-display-inline">The estimated demand in the United States
for such rare pediatric disease product.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H13D4F1D5F2624A1588A603BB8868A2AD"><enum>(C)</enum><text display-inline="yes-display-inline">The actual amount of such rare pediatric
disease product distributed in the United States.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H92226825D5534543A82967D36626E835"><enum>(f)</enum><header display-inline="yes-display-inline">Notice and report</header>
<paragraph commented="no" display-inline="no-display-inline" id="H309CE40434AA40588AE36D832AB56B62"><enum>(1)</enum><header display-inline="yes-display-inline">Notice of issuance of voucher and approval
of products under voucher</header><text display-inline="yes-display-inline">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:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H3D157EAE432D4E269D2DFD2CE29184CD"><enum>(A)</enum><text display-inline="yes-display-inline">The Secretary issues a priority review
voucher under this section.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H64567F919F7E4E87BBA9669CA9AEF0E2"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEDEFF27E69384A708558A5AED552D933"><enum>(2)</enum><header display-inline="yes-display-inline">Notification</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H1E2949460F744DE1B7566F5E2BD3A2CC"><enum>(A)</enum><text display-inline="yes-display-inline">notifying such Committees of the use of
such voucher; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H67B58CF068DC4467847895B7CEAD1AB8"><enum>(B)</enum><text display-inline="yes-display-inline">identifying the drug for which such
priority review voucher is used.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H15DDC925858C464CB986733DFCD6FE22"><enum>(g)</enum><header display-inline="yes-display-inline">Eligibility for other
programs</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HC01DD08B763240A1811D946D9EA10520"><enum>(h)</enum><header display-inline="yes-display-inline">Relation to other provisions</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H74CEB94C98904EF7BFEF727C34358E2B"><enum>(i)</enum><header display-inline="yes-display-inline">GAO study and report</header>
<paragraph commented="no" display-inline="no-display-inline" id="HD11A105AB3804B93BC8ECEB284082B9A"><enum>(1)</enum><header display-inline="yes-display-inline">Study</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H498F381B07174EAD809E5FA8D5F0AF17"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3EBD3595E8524051B2CF200F497617AD"><enum>(B)</enum><header display-inline="yes-display-inline">Contents of study</header><text display-inline="yes-display-inline">In conducting the study under
<internal-xref idref="H498F381B07174EAD809E5FA8D5F0AF17" legis-path="529.(i)(1)(A)">subparagraph (A)</internal-xref>, the Comptroller
General shall examine the following:</text>
<clause commented="no" display-inline="no-display-inline" id="H84E441CA91024290B7F51FA01A92986E"><enum>(i)</enum><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HF1715596549248508D44BE56C2679F75"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H9D346A1B836341B78DE1D3627E1CADA5"><enum>(iii)</enum><text display-inline="yes-display-inline">The value of the priority review voucher if
transferred.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H3B68E00781F443C39E86D4D3C9CC8C69"><enum>(iv)</enum><text display-inline="yes-display-inline">Identification of each drug for which a
priority review voucher was used.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H559A5155BD38401AA6FD8698F12B4F77"><enum>(v)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6F6671A6DC35400D82689AAC0681A9A3"><enum>(2)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">Not later than 1 year after the date under
<internal-xref idref="H498F381B07174EAD809E5FA8D5F0AF17" legis-path="529.(i)(1)(A)">paragraph (1)(A)</internal-xref>, 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
<internal-xref idref="HD11A105AB3804B93BC8ECEB284082B9A" legis-path="529.(i)(1)">paragraph
(1)</internal-xref>.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>X</enum><header display-inline="yes-display-inline">Drug shortages</header>
<section commented="no" display-inline="no-display-inline" id="HF2805D0BF02E4D6B9E0426EE9D4AA22D" section-type="subsequent-section"><enum>1001.</enum><header display-inline="yes-display-inline">Discontinuance or interruption in the
production of life-saving drugs</header>
<subsection commented="no" display-inline="no-display-inline" id="H7D1A1DE508064D448E50F5EA126B2E83"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 506C (21 U.S.C. 356c) is amended to
read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H145AEA467126423390C864FA2797EBD2" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H35053068C76B434FBAF2A5E5E67E95C0" section-type="subsequent-section"><enum>506C.</enum><header display-inline="yes-display-inline">Discontinuance or interruption in the
production of life-saving drugs</header>
<subsection commented="no" display-inline="no-display-inline" id="H51029B2350184B2BB20FD574639EE4F3"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A manufacturer of a drug—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H9309155BC265449EB1941311D803ABA1"><enum>(1)</enum><text display-inline="yes-display-inline">that is—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H6982E2D6DAF4407EB02D00C1728EFBE3"><enum>(A)</enum><text display-inline="yes-display-inline">life-supporting;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD05E6432E0754CEF8039DBB7DAEFEE33"><enum>(B)</enum><text display-inline="yes-display-inline">life-sustaining; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC4054B4B3FCD431BB16F9D47535C69C5"><enum>(C)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HAE53558867184B65B0E818E59E56DDD9"><enum>(2)</enum><text display-inline="yes-display-inline">that is not a radio pharmaceutical drug
product or any other product as designated by the Secretary,</text>
</paragraph><continuation-text commented="no" continuation-text-level="subsection">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.</continuation-text></subsection><subsection commented="no" display-inline="no-display-inline" id="H061EB9DB9C174BAE8AA41D0B5B2AFC8D"><enum>(b)</enum><header display-inline="yes-display-inline">Timing</header><text display-inline="yes-display-inline">A notice required under subsection (a)
shall be submitted to the Secretary—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H2D5EDC03B9A44861B8F490689E189D5F"><enum>(1)</enum><text display-inline="yes-display-inline">at least 6 months prior to the date of the
discontinuance or interruption; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF1594C42963B4E0D9C9797BEC5003275"><enum>(2)</enum><text display-inline="yes-display-inline">if compliance with paragraph (1) is not
possible, as soon as practicable.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H2A0D8B5E306F4C72A27C9F9F302A4CC0"><enum>(c)</enum><header display-inline="yes-display-inline">Distribution</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H5D012E3F556B47488021A7D6F2128A35"><enum>(d)</enum><header display-inline="yes-display-inline">Confidentiality</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H234679E49C16445CB6DE1F5B8B7A678C"><enum>(e)</enum><header display-inline="yes-display-inline">Coordination with Attorney
General</header><text display-inline="yes-display-inline">Not later than 30
days after the receipt of a notification described in subsection (a), the
Secretary shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H6BD57B3BD8E2496291904217AF710379"><enum>(1)</enum><text display-inline="yes-display-inline">determine whether the notification pertains
to a controlled substance subject to a production quota under section 306 of
the Controlled Substances Act; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDACB1549485C498E8906F2B5C3F54F69"><enum>(2)</enum><text display-inline="yes-display-inline">if necessary, as determined by the
Secretary—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H37F0ACC5B90F493F89F1F88DAB7F6FFE"><enum>(A)</enum><text display-inline="yes-display-inline">notify the Attorney General that the
Secretary has received such a notification;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2322C8823854464FB45F2CCF5E2DD17F"><enum>(B)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1E72A7C862A24FF7B5A682055D062FB6"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph">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.</continuation-text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H0C2B506B1A744DC7B1DA737CC82F568D"><enum>(f)</enum><header display-inline="yes-display-inline">Failure To meet requirements</header><text display-inline="yes-display-inline">If a person fails to submit information
required under subsection (a) in accordance with subsection (b)—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H1777A8FE54774D16B6BCE43AB7CC211B"><enum>(1)</enum><text display-inline="yes-display-inline">the Secretary shall issue a letter to such
person informing such person of such failure;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H092AFB78289E45D8B9617B02233724DA"><enum>(2)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H056A3F29DDBC4EE2BFA0D95ED5A9B5F4"><enum>(3)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HE49E454B49E14B2AAF54450D0B2CF470"><enum>(g)</enum><header display-inline="yes-display-inline">Expedited inspections and
reviews</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H8798CBB5878E41E292C62EBAD165BF8F"><enum>(1)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H651F0A6D633F48DEA31CF26231EDE625"><enum>(2)</enum><text display-inline="yes-display-inline">expedite an inspection or reinspection of
an establishment that could help mitigate or prevent such drug shortage.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H668382F249804B1FB9B9CC14D59C63DC"><enum>(h)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">For purposes of this section—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H1EEC542B59754E148A749B6790D0A722"><enum>(1)</enum><text display-inline="yes-display-inline">the term <term>drug</term>—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H28C90357DACA4C7092CDE469D68B1650"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H550AE25C37EB456B9737C08C1D466C24"><enum>(B)</enum><text display-inline="yes-display-inline">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);</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA494485491494CA0995ABDE539783D83"><enum>(2)</enum><text display-inline="yes-display-inline">the term <term>drug shortage</term> or
<term>shortage</term>, 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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7A843D5BBF654F31BDE83EB4A96BF68B"><enum>(3)</enum><text display-inline="yes-display-inline">the term <term>meaningful
disruption</term>—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H9B3B9E938ECC4F358D5597CA202E2962"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3772DFBB3A534D36AB82520D870EFD3F"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H8E519340AF7A4647A5535FC7D3A0AF77"><enum>(i)</enum><header display-inline="yes-display-inline">Regulations</header>
<paragraph commented="no" display-inline="no-display-inline" id="H2A1A748C4E9F4AE2835D7D4742DBBEF9"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 18 months after the date of
enactment of the <short-title>Food and Drug Administration
Safety and Innovation Act</short-title>, the Secretary shall adopt a final
regulation implementing this section.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0B5CDB3ED7F04682910BC7705F77F8DA"><enum>(2)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">Such regulation shall define, for purposes
of this section, the terms <term>life-supporting</term>,
<term>life-sustaining</term>, and <term>intended for use in the prevention or
treatment of a debilitating disease or condition</term>.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H82EC3B4F35C542A38C5F3EC186AB70C3"><enum>(3)</enum><header display-inline="yes-display-inline">Inclusion of biological products</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H2FAFF63E9DDA4B0F9878B9EF38083F61"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1ECE2219C61244CA9A690D2B3ED0BD4A"><enum>(B)</enum><header display-inline="yes-display-inline">Rule for vaccines</header><text display-inline="yes-display-inline">If the Secretary applies this section to
vaccines pursuant to subparagraph (A), the Secretary shall—</text>
<clause commented="no" display-inline="no-display-inline" id="HF53EB5D656534B90B82A1EE473CFB9AB"><enum>(i)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H689D563D8158407EA34D4F4B8350C6CC"><enum>(ii)</enum><text display-inline="yes-display-inline">explain the determination made by the
Secretary under clause (i) in the regulation.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H43F404524DEF4DF5A3CBB057F9F15BCB"><enum>(4)</enum><header display-inline="yes-display-inline">Procedure</header><text display-inline="yes-display-inline">In promulgating a regulation implementing
this section, the Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HD9458DDC79CD49869CAB6DFC8D8E06B0"><enum>(A)</enum><text display-inline="yes-display-inline">issue a notice of proposed rulemaking that
includes the proposed regulation;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC590DAF72B47497D96D8CB3F476A4887"><enum>(B)</enum><text display-inline="yes-display-inline">provide a period of not less than 60 days
for comments on the proposed regulation; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6D22BA8367B74A73BC8573C5BAD4F58B"><enum>(C)</enum><text display-inline="yes-display-inline">publish the final regulation not less than
30 days before the regulation’s effective date.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDC51319F6A1E4780B119135C559C95FE"><enum>(5)</enum><header display-inline="yes-display-inline">Restrictions</header><text display-inline="yes-display-inline">Notwithstanding any other provision of
Federal law, in implementing this section, the Secretary shall only promulgate
regulations as described in paragraph
(4).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H576FCD3333F8459A9E6D702844A6A9EC"><enum>(b)</enum><header display-inline="yes-display-inline">Effect of notification</header><text display-inline="yes-display-inline">The submission of a notification to the
Secretary of Health and Human Services (referred to in this title as the
<quote>Secretary</quote>) 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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H10C4A75938EE4BA4AC427730E42385AB"><enum>(1)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3965BEBC3AC04C0F819650847559EED6"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="HF6CD632EC23943AE90CA49C198F98797" section-type="subsequent-section"><enum>1002.</enum><header display-inline="yes-display-inline">Annual reporting on drug
shortages</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="H825E5AF879E6437B8482863E7C685913" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HB66461D326CA40CBA10C5F0870015C6F" section-type="subsequent-section"><enum>506C–1.</enum><header display-inline="yes-display-inline">Annual reporting on drug shortages</header>
<subsection commented="no" display-inline="no-display-inline" id="H6CAA7CC955CB46D7961AB782DBE2F454"><enum>(a)</enum><header display-inline="yes-display-inline">Annual reports to Congress</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HFB977663C0E04A479924D4436CC560E4"><enum>(1)</enum><text display-inline="yes-display-inline">specifies the number of manufacturers that
submitted a notification to the Secretary under section 506C(a) during such
calendar year;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7E101C9328D14D3A834BE893DAD69135"><enum>(2)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HACEEDB2ADEAD4B60BB64C9039F3674EB"><enum>(3)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HB8BED8B95EAB47DEBB1C6A4F867BC103"><enum>(A)</enum><text display-inline="yes-display-inline">lists the major actions taken by the
Secretary to prevent or mitigate the drug shortages described in paragraph
(7);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0A70F243327E4CC888F13905E19F8F45" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">in the list under subparagraph (A),
includes—</text>
<clause commented="no" display-inline="no-display-inline" id="H5D0EB4AA37054A6A9CB6B15D7F6322D4"><enum>(i)</enum><text display-inline="yes-display-inline">the number of applications and supplements
for which the Secretary expedited review under section 506C(g)(1) during such
calendar year; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H847BA3D1682B430880C4FD1E2733115B"><enum>(ii)</enum><text display-inline="yes-display-inline">the number of establishment inspections or
reinspections that the Secretary expedited under section 506C(g)(2) during such
calendar year;</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H447A1AC3C9D640E085AFB80872F4BAFE"><enum>(4)</enum><text display-inline="yes-display-inline">describes the coordination between the Food
and Drug Administration and the Drug Enforcement Administration on efforts to
prevent or alleviate drug shortages;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H14C64F187B7147B3A8103A6113128A88"><enum>(5)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0CB737284E9D496BBBBC766E077CF163"><enum>(6)</enum><text display-inline="yes-display-inline">lists the names of manufacturers that were
issued letters under section 506C(f); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1BC4DB8613794A4BB563C855369D0FBC"><enum>(7)</enum><text display-inline="yes-display-inline">specifies the number of drug shortages
occurring during such calendar year, as identified by the Secretary.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H907AD05C25744B439F9522ABFF1719FA"><enum>(b)</enum><header display-inline="yes-display-inline">Trend
analysis</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HB75F1718D0FF460FB761B090732483AE"><enum>(c)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">In this section, the term <term>drug
shortage</term> or <term>shortage</term> has the meaning given such term in
section
506C.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H11512F1D438A4E38ACF85C862CBC1743" section-type="subsequent-section"><enum>1003.</enum><header display-inline="yes-display-inline">Coordination; task force and strategic
plan</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="HE877AD4D8F894FC0B25E4B52D733EA00" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HAFBD41DCBEBB40EDAB18AE16FEC1E2E1" section-type="subsequent-section"><enum>506D.</enum><header display-inline="yes-display-inline">Coordination; task force and strategic
plan</header>
<subsection commented="no" display-inline="no-display-inline" id="H56FC6E23F5FF453D84A0EABB3FBD7B35"><enum>(a)</enum><header display-inline="yes-display-inline">Task force and strategic plan</header>
<paragraph commented="no" display-inline="no-display-inline" id="HB79BBA747DC34AFF86949712C2CAB463"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H384E658B86964D4E876AE5618DCF7ED5"><enum>(A)</enum><header display-inline="yes-display-inline">Task Force</header><text display-inline="yes-display-inline">As soon as practicable after the date of
enactment of the <short-title>Food and Drug Administration
Safety and Innovation Act</short-title>, 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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H45D4FC3CDA5B42F6B00DB7D837FAC709"><enum>(B)</enum><header display-inline="yes-display-inline">Strategic
plan</header><text display-inline="yes-display-inline">The strategic plan
described in subparagraph (A) shall include—</text>
<clause commented="no" display-inline="no-display-inline" id="H0CC02B871DD84A9396906E2C109C8014"><enum>(i)</enum><text display-inline="yes-display-inline">plans for enhanced interagency and
intra-agency coordination, communication, and decisionmaking;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HA36D5AF896F9419C963B8B1B617239A7"><enum>(ii)</enum><text display-inline="yes-display-inline">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;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HFFB4471F4C4644969FD1A426F6DDE667"><enum>(iii)</enum><text display-inline="yes-display-inline">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;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H14A5ABA227C14765963F3E84330A6272"><enum>(iv)</enum><text display-inline="yes-display-inline">plans for considering the impact of drug
shortages on research and clinical trials; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HA2EA8FA0433F4A80AE2037840EC41807"><enum>(v)</enum><text display-inline="yes-display-inline">an examination of whether to establish a
<quote>qualified manufacturing partner program</quote>, as described in
subparagraph (C).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAF08A8834DC84B389777C14371E8F875"><enum>(C)</enum><header display-inline="yes-display-inline">Description of program</header><text display-inline="yes-display-inline">In conducting the examination of a
<quote>qualified manufacturing partner program</quote> under subparagraph
(B)(v), the Secretary—</text>
<clause commented="no" display-inline="no-display-inline" id="H90207F64DDA440CEADAC8A9D8919CA48"><enum>(i)</enum><text display-inline="yes-display-inline">shall take into account that—</text>
<subclause commented="no" display-inline="no-display-inline" id="H163FEF8595C04E17B012E492547C0428"><enum>(I)</enum><text display-inline="yes-display-inline">a <quote>qualified manufacturer</quote>,
for purposes of such program, would need to have the capability and capacity to
supply products determined or anticipated to be in shortage; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H6E43701F1EB94EC7873803B0768B6047"><enum>(II)</enum><text display-inline="yes-display-inline">in examining the capability and capacity to
supply products in shortage, the <quote>qualified manufacturer</quote> 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</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="HFB39F0F6DD294712BDC2BD7724F4933F"><enum>(ii)</enum><text display-inline="yes-display-inline">shall examine whether incentives are
necessary to encourage the participation of <quote>qualified
manufacturers</quote> in such a program.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7E491D5D3F094A988761EC8A332A4F98"><enum>(D)</enum><header display-inline="yes-display-inline">Consultation</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H18F70BC96FE14F47843CF358159D9737"><enum>(2)</enum><header display-inline="yes-display-inline">Timing</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of the <short-title>Food and Drug Administration
Safety and Innovation Act</short-title>, the task force shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HE72D2C4963824C3484BF72FEACBF5A2E"><enum>(A)</enum><text display-inline="yes-display-inline">publish the strategic plan described in
paragraph (1); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H56B586BE95ED4D3C8B208BE1A3A22C6F"><enum>(B)</enum><text display-inline="yes-display-inline">submit such plan to Congress.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HB5E29773EF0A42858BBA199FB543763A"><enum>(b)</enum><header display-inline="yes-display-inline">Communication</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H449CB4CF8792427A9D61E3C6F4970503"><enum>(c)</enum><header display-inline="yes-display-inline">Action</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HC72772E282F848CD8E0E12B80D165B50"><enum>(d)</enum><header display-inline="yes-display-inline">Reporting by other entities</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H41D2ED29C3C940679D860FEACE976EAF"><enum>(e)</enum><header display-inline="yes-display-inline">Review and construction</header><text display-inline="yes-display-inline">No determination, finding, action, or
omission of the Secretary under this section shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HEEF0D5AAF69548F78082E09E4674C3C7"><enum>(1)</enum><text display-inline="yes-display-inline">be subject to judicial review; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H8946AEAE39854C16828E17BEDAD6FF4C"><enum>(2)</enum><text display-inline="yes-display-inline">be construed to establish a defense to an
enforcement action by the Secretary.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H02A4CBF1F1D34FC4963BBC8A354AC5AA"><enum>(f)</enum><header display-inline="yes-display-inline">Sunset</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="HD930DD9DCB1E48A3B24D3C915D5858B2" section-type="subsequent-section"><enum>1004.</enum><header display-inline="yes-display-inline">Drug shortage list</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="HA2613BF025144024A0AAAD267CF3388A" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HC787CD89F1C44FD098D22A462EB21625" section-type="subsequent-section"><enum>506E.</enum><header display-inline="yes-display-inline">Drug shortage list</header>
<subsection commented="no" display-inline="no-display-inline" id="H0C20C1534E044C649595BA8E37CA4E2A"><enum>(a)</enum><header display-inline="yes-display-inline">Establishment</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HE9DBE5D77F8F4107B4E3DB80A5C0497F"><enum>(b)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">For each drug on such list, the Secretary
shall include the following information:</text>
<paragraph commented="no" display-inline="no-display-inline" id="H9E0B1122C0A0413D96F14952BF92A22B"><enum>(1)</enum><text display-inline="yes-display-inline">The name of the drug in shortage, including
the National Drug Code number for such drug.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7F43536FEA354F2583389CAB0E4F44F9"><enum>(2)</enum><text display-inline="yes-display-inline">The name of each manufacturer of such
drug.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2F5A0520421544DEBC249CBEB7125493"><enum>(3)</enum><text display-inline="yes-display-inline">The reason for the shortage, as determined
by the Secretary, selecting from the following categories:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HA496669F4A81492B9CA87F9FCA33DBB1"><enum>(A)</enum><text display-inline="yes-display-inline">Requirements related to complying with good
manufacturing practices.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9ABA8156AE59421DAB4679C95577EF38"><enum>(B)</enum><text display-inline="yes-display-inline">Regulatory delay.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H85624A843766432D923BAC3319C9BD91"><enum>(C)</enum><text display-inline="yes-display-inline">Shortage of an active ingredient.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9918F24F002945FD84D29408A7807BC3"><enum>(D)</enum><text display-inline="yes-display-inline">Shortage of an inactive ingredient
component.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H44D01F8B8BF9454D8C54F642D9A7A048"><enum>(E)</enum><text display-inline="yes-display-inline">Discontinuation of the manufacture of the
drug.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H19DB25AD3FDD4681B5BE1AD4C0444F3A"><enum>(F)</enum><text display-inline="yes-display-inline">Delay in shipping of the drug.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD7ECC7A9554F487CBD1163B3CD06F615"><enum>(G)</enum><text display-inline="yes-display-inline">Demand increase for the drug.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4CC9AAD30C2946EBACF5D8E6087686F1"><enum>(4)</enum><text display-inline="yes-display-inline">The estimated duration of the shortage as
determined by the Secretary.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H91CDB1CCFB9541FB8ECAC3534562DDD4"><enum>(c)</enum><header display-inline="yes-display-inline">Public availability</header>
<paragraph commented="no" display-inline="no-display-inline" id="HA0B117D6D95D43F281F0888E5FD1F9AE"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subject to paragraphs (2) and (3), the
Secretary shall make the information in such list publicly available.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9571661DA07B48339B0263BD76C5636C"><enum>(2)</enum><header display-inline="yes-display-inline">Trade secrets and confidential
information</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5D710C2A88F449BA9945602DAA5BB426"><enum>(3)</enum><header display-inline="yes-display-inline">Public health exception</header><text display-inline="yes-display-inline">The Secretary may choose not to make
information collected under this section publicly available under
<internal-xref idref="HA0B117D6D95D43F281F0888E5FD1F9AE" legis-path="506D.(c)(1)">paragraph (1) or section 506C(c)</internal-xref> 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).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H5367C80023EB41ADB39C7DD36582FBE6" section-type="subsequent-section"><enum>1005.</enum><header display-inline="yes-display-inline">Quotas applicable to drugs in
shortage</header><text display-inline="no-display-inline">Section 306 of the
Controlled Substances Act (21 U.S.C. 826) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H6D32EAD55F2F4CF29F36BE6AF41D3AFA" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H1F0BEC29F9BF473F81711E565A2E03F6"><enum>(h)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H6B1AADE612414A90BFB262FF01DB831B"><enum>(1)</enum><text display-inline="yes-display-inline">Not later than 30 days after the receipt of
a request described in paragraph (2), the Attorney General shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H46E95DDAEDE241189D680D90C2EEE484" indent="up1"><enum>(A)</enum><text display-inline="yes-display-inline">complete review of such request; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3179FEFE5EB44603A147E5FA35C55F88" indent="up1"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="H36424BCD348F4D79B95CA8BA21C03A3D"><enum>(i)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H52B37AB2BBF4472F9E38FC03EC88637C" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph></paragraph><continuation-text commented="no" continuation-text-level="subsection">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.</continuation-text><paragraph commented="no" display-inline="no-display-inline" id="H8E24DFA3DC514763BE3110FFFE2C9ACA" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">A
request is described in this paragraph if—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HA4CA95D33D7A47F3AEDBB5A75D5AC0D5"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA13A0CC9F14D4636892852D3CBEBF2BA"><enum>(B)</enum><text display-inline="yes-display-inline">the request is submitted by the
manufacturer of the controlled substance; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6884409C72C54AACA25ABFB99A00395F"><enum>(C)</enum><text display-inline="yes-display-inline">the controlled substance is in schedule
II.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="HC0894E96676344B7B33AEDC3EB61ACF2" section-type="subsequent-section"><enum>1006.</enum><header display-inline="yes-display-inline">Attorney General report on drug
shortages</header><text display-inline="no-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HEE84A50BE9784A05909F51E72329339A"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H58DA80F7F1AA470FAFB1D36114329ACE"><enum>(2)</enum><text display-inline="yes-display-inline">describes the coordination between the Drug
Enforcement Administration and Food and Drug Administration on efforts to
prevent or alleviate drug shortages; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HAD9354DBF6664ECFAABEAE1C05128C1E"><enum>(3)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H8191D2005D1748CC9865C99FDCB9DE42" section-type="subsequent-section"><enum>1007.</enum><header display-inline="yes-display-inline">Hospital repackaging of drugs in
shortage</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="H56EAFCC33A4F4DE6880D35BC4218E15A" style="OLC">
<section commented="no" display-inline="no-display-inline" id="H864F58703C964FF9AB7BD92ED3629A99" section-type="subsequent-section"><enum>506F.</enum><header display-inline="yes-display-inline">Hospital repackaging of drugs in
shortage</header>
<subsection commented="no" display-inline="no-display-inline" id="H982C7DB3BA4040148D33AFB944CB2DB0"><enum>(a)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this section:</text>
<paragraph commented="no" display-inline="no-display-inline" id="HF2FFB854C3D443058EB2549E26D43429"><enum>(1)</enum><header display-inline="yes-display-inline">Drug</header><text display-inline="yes-display-inline">The term <term>drug</term> excludes any
controlled substance (as such term is defined in section 102 of the Controlled
Substances Act).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H23722215688D41BD862A1C78BA7E774D"><enum>(2)</enum><header display-inline="yes-display-inline">Health system</header><text display-inline="yes-display-inline">The term <term>health system</term> 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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE1D52626623F4A4DAD5B12A11ACDEAD1"><enum>(3)</enum><header display-inline="yes-display-inline">Repackage</header><text display-inline="yes-display-inline">For the purposes of this section only, the
term <term>repackage</term>, with respect to a drug, means to divide the volume
of a drug into smaller amounts in order to—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HAF1612707D0D45FD91B4C46400615CB7"><enum>(A)</enum><text display-inline="yes-display-inline">extend the supply of a drug in response to
the placement of the drug on a drug shortage list under section 506E;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3D8F8CEDA98547448DCAC931CCFEC290"><enum>(B)</enum><text display-inline="yes-display-inline">facilitate access to the drug by hospitals
within the same health system.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HC0257809C542487882740D5E1E9D3FD2"><enum>(b)</enum><header display-inline="yes-display-inline">Exclusion from registration</header><text display-inline="yes-display-inline">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)—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H8C3D44442EAB44DE81923630281107E5"><enum>(1)</enum><text display-inline="yes-display-inline">during any period in which the drug is
listed on the drug shortage list under section 506E; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H295077CC046D4B6199480D43C1C9B486"><enum>(2)</enum><text display-inline="yes-display-inline">during the 60-day period following any
period described in paragraph (1).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H416DCB8C04F04E9DAE946DB530776EDD"><enum>(c)</enum><header display-inline="yes-display-inline">Conditions</header><text display-inline="yes-display-inline">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:</text>
<paragraph commented="no" display-inline="no-display-inline" id="H6F2AFE2ADBAF4A29B55EBEBB79897810"><enum>(1)</enum><header display-inline="yes-display-inline">Drug for intrasystem use only</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFB67B1F7DACC45E2B03A4E1187D611A7"><enum>(2)</enum><header display-inline="yes-display-inline">Compliance with State rules</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H4F670DADE44445CCA466A341DACD2F4A"><enum>(d)</enum><header display-inline="yes-display-inline">Termination</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H62180145E96F4821879E9597B6420729" section-type="subsequent-section"><enum>1008.</enum><header display-inline="yes-display-inline">Study on drug shortages</header>
<subsection commented="no" display-inline="no-display-inline" id="H0C251DB42D4C4C4A8143DFEA8E19CF4E"><enum>(a)</enum><header display-inline="yes-display-inline">Study</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HD66C1D3D0AFB4138B6E75E9F6755C84D"><enum>(b)</enum><header display-inline="yes-display-inline">Consideration</header><text display-inline="yes-display-inline">In conducting the study under this section,
the Comptroller General shall consider the following questions:</text>
<paragraph commented="no" display-inline="no-display-inline" id="H63F859C15BD6495CB4905B688F908341"><enum>(1)</enum><text display-inline="yes-display-inline">What are the dominant characteristics of
drugs that have gone into a drug shortage over the preceding 3 years?</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7BAA49D525B1415CAB1F635CA83EA07A"><enum>(2)</enum><text display-inline="yes-display-inline">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?</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H327D56743A86484DB217004505DE4F29"><enum>(3)</enum><text display-inline="yes-display-inline">Is there a reason why drug shortages have
occurred primarily in the sterile injectable market and in certain therapeutic
areas?</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFFED9234663F4C369AE6709A5498F21C"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HF4C458B1F46048BCBD327182C962A246"><enum>(A)</enum><text display-inline="yes-display-inline">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?</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H96001309F41B4863AB03EB613C315E5E" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">Do any such regulations, guidances,
policies, or practices cause, exacerbate, prevent, or mitigate drug
shortages?</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H54ED00B4ADD14452B541E42DAEA44495" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">How can regulations, guidances, policies,
or practices be modified, streamlined, expanded, or discontinued in order to
reduce or prevent such drug shortages?</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H36284F73AE7045F68404368C34AA2003" indent="up1"><enum>(D)</enum><text display-inline="yes-display-inline">What effect would the changes described in
subparagraph (C) have on the public health?</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFCCB17F8BFB04B27AA47E8FB157F34CD"><enum>(5)</enum><text display-inline="yes-display-inline">How does hoarding affect drug
shortages?</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H461BBCAEE80841C6BEB64173FD0E07DA"><enum>(6)</enum><text display-inline="yes-display-inline">How would incentives alleviate or prevent
drug shortages?</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBABB573A59084557A305CED335C2E813"><enum>(7)</enum><text display-inline="yes-display-inline">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?</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4F3C46A5C7B2407DB1F7B3E86EFD9A86"><enum>(8)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HFFCFCADF149F44AEB0275CABE8F279B0"><enum>(A)</enum><text display-inline="yes-display-inline">Have drug shortages led market participants
to stockpile affected drugs or sell such drugs at inflated prices?</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAB2ECEA9EEE84184B22F75490EF0C173" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">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?</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDE61F3F8A5FA4928A06ED8EC0B8B3BB9" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">Is there a need for any additional
reporting or enforcement actions to address such activities?</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1A01DFE41B33452AA6F8C55863BF0AAC"><enum>(9)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H78E9A32DFA8444BFAD21E2CD43F10476"><enum>(A)</enum><text display-inline="yes-display-inline">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?</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEED970B52C994D7BB7F281C6749E3C62" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">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?</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H2DD45BF687C54F79862F5812941F6C75"><enum>(c)</enum><header display-inline="yes-display-inline">Consultation with
stakeholders</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H6295C286215243C581DEAD2527AF3137"><enum>(d)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><enum>XI</enum><header display-inline="yes-display-inline">Other provisions</header>
<subtitle commented="no" id="H192468F216D145C8B2F9A21E241B189A" level-type="subsequent"><enum>A</enum><header display-inline="yes-display-inline">Reauthorizations</header>
<section commented="no" display-inline="no-display-inline" id="HE8A76BB45A0C4382A66921A7A97F9921" section-type="subsequent-section"><enum>1101.</enum><header display-inline="yes-display-inline">Reauthorization of provision relating to
exclusivity of certain drugs containing single enantiomers</header>
<subsection commented="no" display-inline="no-display-inline" id="H38C40D4FE73F48839A995512E582CE81"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 505(u)(4) (21 U.S.C. 355(u)(4)) is
amended by striking <quote>2012</quote> and inserting
<quote>2017</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H39645D8925AF422D90ACBD6D17B26F51"><enum>(b)</enum><header display-inline="yes-display-inline">Amendment</header><text display-inline="yes-display-inline">Section 505(u)(1)(A)(ii)(II) (21 U.S.C.
355(u)(1)(A)(ii)(II)) is amended by inserting <quote>clinical</quote> after
<quote>any</quote>.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HE03D201A9F414BED90A64D9A975983C9" section-type="subsequent-section"><enum>1102.</enum><header display-inline="yes-display-inline">Reauthorization of the critical path
public-private partnerships</header><text display-inline="no-display-inline">Subsection (f) of section 566 (21 U.S.C.
360bbb–5) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HCDF245ED4CD5478C9801A3F55E501B68" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H273FFFA08A1D47FDB04BE7F5B9AE7CBB"><enum>(f)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">To carry out
this section, there is authorized to be appropriated $6,000,000 for each of
fiscal years 2013 through
2017.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section></subtitle><subtitle commented="no" id="HABDD6F09E13C420C8CC149F83BD466EA" level-type="subsequent"><enum>B</enum><header display-inline="yes-display-inline">Medical gas product regulation</header>
<section commented="no" display-inline="no-display-inline" id="H697E41B38E78401F88733D545A015149" section-type="subsequent-section"><enum>1111.</enum><header display-inline="yes-display-inline">Regulation of medical gases</header><text display-inline="no-display-inline">Chapter V (21 U.S.C. 351 et seq.) is amended
by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HEBCC79A34E2341D5AE0371699CD70288" style="OLC">
<subchapter commented="no" id="HE3B5FCD3636345AEB845B26794448E80" level-type="subsequent"><enum>G</enum><header display-inline="yes-display-inline">Medical gases</header>
<section commented="no" display-inline="no-display-inline" id="HBAF37A0ED6554BE9A2653C0933874BBD" section-type="subsequent-section"><enum>575.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">In this subchapter:</text>
<paragraph commented="no" display-inline="no-display-inline" id="HF01779DA55284731B7A128F8BE507C61"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>designated medical
gas</term> means any of the following:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H2BE4F4C7B9714BF190EB7D91F44ED2B4"><enum>(A)</enum><text display-inline="yes-display-inline">Oxygen that meets the standards set forth
in an official compendium.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H230978CE9061418BA6027D8355A7ECB4"><enum>(B)</enum><text display-inline="yes-display-inline">Nitrogen that meets the standards set forth
in an official compendium.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3B2332508BDB4FDB8BBFBCA79C6DF000"><enum>(C)</enum><text display-inline="yes-display-inline">Nitrous oxide that meets the standards set
forth in an official compendium.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H60351A1F8A41452B9985CC943FFF9095"><enum>(D)</enum><text display-inline="yes-display-inline">Carbon dioxide that meets the standards set
forth in an official compendium.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H575506D9B7884A378E3C5C74D1F345EC"><enum>(E)</enum><text display-inline="yes-display-inline">Helium that meets the standards set forth
in an official compendium.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H267DF7AA3162451BABC2A9C0C53B4F69"><enum>(F)</enum><text display-inline="yes-display-inline">Carbon monoxide that meets the standards
set forth in an official compendium.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB23A93C2FD4140B79B17BA23052C60BB"><enum>(G)</enum><text display-inline="yes-display-inline">Medical air that meets the standards set
forth in an official compendium.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H1740826DECF84FD48A64AF2A56666829"><enum>(H)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H68F4172B7BA848FE8165A466C3238510"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>medical gas</term> means a
drug that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H624D740F9F0A46C2A11E6DAA8F8726BB"><enum>(A)</enum><text display-inline="yes-display-inline">is manufactured or stored in a liquefied,
nonliquefied, or cryogenic state; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H70F35B6B61DD4B20A1F503AA08CA24C8"><enum>(B)</enum><text display-inline="yes-display-inline">is administered as a gas.</text>
</subparagraph></paragraph></section><section commented="no" display-inline="no-display-inline" id="H1EED2ABAB26142EB942F2C4B5BA042BA" section-type="subsequent-section"><enum>576.</enum><header display-inline="yes-display-inline">Regulation of medical gases</header>
<subsection commented="no" display-inline="no-display-inline" id="H8B8CBC2CF6CD4CB989B4A90DDEBF30EF"><enum>(a)</enum><header display-inline="yes-display-inline">Certification of designated medical
gases</header>
<paragraph commented="no" display-inline="no-display-inline" id="H0C381F3682A64730808FDE8A6A9E889C"><enum>(1)</enum><header display-inline="yes-display-inline">Submission</header><text display-inline="yes-display-inline">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:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H879D2ABB2D7546E89F7BA2743EF9F359"><enum>(A)</enum><text display-inline="yes-display-inline">A description of the medical gas.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H79A22D7810764AD6840F1C63DF1F8EFC"><enum>(B)</enum><text display-inline="yes-display-inline">The name and address of the sponsor.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HFAD6BB6E313D4911A8E0DF766C5E0EA2"><enum>(C)</enum><text display-inline="yes-display-inline">The name and address of the facility or
facilities where the medical gas is or will be manufactured.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H938272C784394B7EA73E2635B1E41F0B"><enum>(D)</enum><text display-inline="yes-display-inline">Any other information deemed appropriate by
the Secretary to determine whether the medical gas is a designated medical
gas.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1B9B368B89EA4EC29EF1045F761B7112"><enum>(2)</enum><header display-inline="yes-display-inline">Grant of certification</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H6DA7A7CC0FC1479287307CE79A8D0C6D"><enum>(A)</enum><text display-inline="yes-display-inline">the medical gas subject to the
certification is not a designated medical gas;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H510028F0F8CB4C748472249107091330"><enum>(B)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H513D822365B144A7AD9F42D9EF225C9B"><enum>(C)</enum><text display-inline="yes-display-inline">denying the request is necessary to protect
the public health.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HAADC300300F74296A2DBF88F7F3372C5"><enum>(3)</enum><header display-inline="yes-display-inline">Effect of certification</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H96C3DCA10E1A4B8ABE7CBFF120C518BA"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header>
<clause commented="no" display-inline="no-display-inline" id="H2E2BE7C7388140448066C40016FF126B"><enum>(i)</enum><header display-inline="yes-display-inline">Approved uses</header><text display-inline="yes-display-inline">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:</text>
<subclause commented="no" display-inline="no-display-inline" id="H10D0B571B7DB45D48AF356BFF93606BE"><enum>(I)</enum><text display-inline="yes-display-inline">In the case of oxygen, the treatment or
prevention of hypoxemia or hypoxia.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H7402588E9CAD483A810E4C5A34007BBF"><enum>(II)</enum><text display-inline="yes-display-inline">In the case of nitrogen, use in hypoxic
challenge testing.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H4CFE8F04643D49638924931C8F4D346B"><enum>(III)</enum><text display-inline="yes-display-inline">In the case of nitrous oxide,
analgesia.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HE1601AC121B24B9B8B1767E8A5FDC94E"><enum>(IV)</enum><text display-inline="yes-display-inline">In the case of carbon dioxide, use in
extracorporeal membrane oxygenation therapy or respiratory stimulation.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HB7F8DFC726234A12B85C072B3DB14DAC"><enum>(V)</enum><text display-inline="yes-display-inline">In the case of helium, the treatment of
upper airway obstruction or increased airway resistance.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HA9FDBD3FEB1A45199FDFF9706885BD42"><enum>(VI)</enum><text display-inline="yes-display-inline">In the case of medical air, to reduce the
risk of hyperoxia.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HFB28DC0E781D41A6BF7FC7F26EE40013"><enum>(VII)</enum><text display-inline="yes-display-inline">In the case of carbon monoxide, use in lung
diffusion testing.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H3E0E5779D49D4FB7BA3F598C19A76B9E"><enum>(VIII)</enum><text display-inline="yes-display-inline">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.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="HBE1F645DCF0A48F299BE8CC6B143F888"><enum>(ii)</enum><header display-inline="yes-display-inline">Labeling</header><text display-inline="yes-display-inline">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—</text>
<subclause commented="no" display-inline="no-display-inline" id="HBFD3AC51876041B4B5FEC96A65F00985"><enum>(I)</enum><text display-inline="yes-display-inline">the information required by section
503(b)(4);</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H3B98D79070EA4B3F818EFB021E3A4152"><enum>(II)</enum><text display-inline="yes-display-inline">a warning statement concerning the use of
the medical gas as determined by the Secretary by regulation; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HF5EB9BE422D44C1787C62002569FC4F7"><enum>(III)</enum><text display-inline="yes-display-inline">appropriate directions and warnings
concerning storage and handling.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB7D29FD326E3404DBB02EE5A1F05AF3C"><enum>(B)</enum><header display-inline="yes-display-inline">Inapplicability of exclusivity
provisions</header>
<clause commented="no" display-inline="no-display-inline" id="H8630420D01134258AEC9BB21EB063BDD"><enum>(i)</enum><header display-inline="yes-display-inline">No exclusivity for a certified medical
gas</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HCBC58E86AC7A45E29E15BB545CC71BBF"><enum>(ii)</enum><header display-inline="yes-display-inline">Effect on certification</header><text display-inline="yes-display-inline">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).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5AA1D28D3B3445C3B8B3BB8A8FAF75F1"><enum>(4)</enum><header display-inline="yes-display-inline">Withdrawal, suspension, or revocation of
approval</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H0F1DC4D3E83142ABAF17F5347D402F13"><enum>(A)</enum><header display-inline="yes-display-inline">Withdrawal, suspension of
approval</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H66AAE4B95FC34A068B116B0D877C49EB"><enum>(B)</enum><header display-inline="yes-display-inline">Revocation of certification</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H781287A586DF468F9C909F8D911F715F"><enum>(b)</enum><header display-inline="yes-display-inline">Prescription requirement</header>
<paragraph commented="no" display-inline="no-display-inline" id="HCF492AA1DBE94C3AB9915F6C1EA4C20E"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H56B71A41A9474E7585BFD84E2380E32B"><enum>(2)</enum><header display-inline="yes-display-inline">Oxygen</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H08160706007148BFB48A40286BC27E37"><enum>(A)</enum><header display-inline="yes-display-inline">No prescription required for certain
uses</header><text display-inline="yes-display-inline">Notwithstanding
paragraph (1), oxygen may be provided without a prescription for the following
uses:</text>
<clause commented="no" display-inline="no-display-inline" id="H77A2CA61AC8A4151BD618DC3A91788E7"><enum>(i)</enum><text display-inline="yes-display-inline">For use in the event of depressurization or
other environmental oxygen deficiency.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HB10B8F8256174D18B910BA8583D286CB"><enum>(ii)</enum><text display-inline="yes-display-inline">For oxygen deficiency or for use in
emergency resuscitation, when administered by properly trained
personnel.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H189804F93F52483FABCF876150866A51"><enum>(B)</enum><header display-inline="yes-display-inline">Labeling</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="HCD9D0F839278472499EFA5C9A08ADCC1" section-type="subsequent-section"><enum>577.</enum><header display-inline="yes-display-inline">Inapplicability of drug fees to designated
medical gases</header><text display-inline="no-display-inline">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.</text>
</section></subchapter><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H1428491A3BD24F2188AC37C0A635B141" section-type="subsequent-section"><enum>1112.</enum><header display-inline="yes-display-inline">Changes to regulations</header>
<subsection commented="no" display-inline="no-display-inline" id="H1657EB7ECF754F628355C26B7A1BADF5"><enum>(a)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H5B5315F1E0504658A6B786AA76AA23AE"><enum>(1)</enum><text display-inline="yes-display-inline">determine whether any changes to the
Federal drug regulations are necessary for medical gases; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H22921B4C227648E48F38EE42EDEDECF9"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF4B46675C0CB45D392D8A3292741D3B0"><enum>(b)</enum><header display-inline="yes-display-inline">Regulations</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HE43B6CCCF233478EB4C2BDD5A97FEA4E"><enum>(c)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this section:</text>
<paragraph commented="no" display-inline="no-display-inline" id="HEEA0F10CDC0E43A88371B2158F04CC59"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>Federal drug
regulations</term> means regulations in title 21 of the Code of Federal
Regulations pertaining to drugs.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5DC1100E84124A858C4F606AB72A0B2A"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>medical gas</term> 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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2C59147E41D2499BB625C3A32B3D640A"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>Secretary</term> means the
Secretary of Health and Human Services, acting through the Commissioner of Food
and Drugs.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H0343F14CE3834625A1D379FD504FA80A" section-type="subsequent-section"><enum>1113.</enum><header display-inline="yes-display-inline">Rules of construction</header><text display-inline="no-display-inline">Nothing in this subtitle and the amendments
made by this subtitle applies with respect to—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HD019114B954846DF9C8A8B9B175CA994"><enum>(1)</enum><text display-inline="yes-display-inline">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);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9850FAA24B044D4ABDAF823AA6953B0C"><enum>(2)</enum><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H63379796DAC940699FBC2C81C9155C1C"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H480B79C7FC7B45B080DFFE1A929C2B23"><enum>(B)</enum><text display-inline="yes-display-inline">is approved on or after May 1, 2012,
pursuant to an application submitted under section 505 or 512; or</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H94D672F175ED4C46A3CD225BA5456EAA"><enum>(3)</enum><text display-inline="yes-display-inline">any designated medical gas added pursuant
to subparagraph (H) of section 575(1) of such Act for an indication
that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H7A748D6DBCFB4D20B3FE05C539A91855"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBE909C24F28442E7A7952324B813C1E7"><enum>(B)</enum><text display-inline="yes-display-inline">is approved on or after May 1, 2012,
pursuant to an application submitted under section 505 or 512 of such
Act.</text>
</subparagraph></paragraph></section></subtitle><subtitle commented="no" id="HA3DEFBC9E4CC4FFEBB296D81F63EC88C" level-type="subsequent"><enum>C</enum><header display-inline="yes-display-inline">Miscellaneous provisions</header>
<section commented="no" display-inline="no-display-inline" id="H41F0F3A0D75D4D4586ADCBA4E7762F1E" section-type="subsequent-section"><enum>1121.</enum><header display-inline="yes-display-inline">Guidance document regarding product
promotion using the Internet</header><text display-inline="no-display-inline">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.</text>
</section><section commented="no" display-inline="no-display-inline" id="HF9CD65B0CF4843318931C5F1173D304F" section-type="subsequent-section"><enum>1122.</enum><header display-inline="yes-display-inline">Combating prescription drug abuse</header>
<subsection commented="no" display-inline="no-display-inline" id="HD4DB68BC9A2F487DA6CDCF2FCAC00E00"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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
<quote>Secretary</quote>), in coordination with other Federal agencies, as
appropriate, shall review current Federal initiatives and identify gaps and
opportunities with respect to—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HCC14A2B0CA334D808DBBEABFCFD2116F"><enum>(1)</enum><text display-inline="yes-display-inline">ensuring the safe use of prescription drugs
with the potential for abuse; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF7275AB06753477DB41956D257706E39"><enum>(2)</enum><text display-inline="yes-display-inline">the treatment of prescription drug
dependance.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HCAA10C069AC541A8B15E27774B405033"><enum>(b)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H8AE927208CA5435DA98A9DB51E7FA1DF"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H108A713D9D8F490B80304C00635EC714"><enum>(2)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H824A19819DE4452DAEAB8A5732107D81"><enum>(3)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HC83D46684F0A41B8A8E203EC780840F3"><enum>(c)</enum><header display-inline="yes-display-inline">Guidance on Abuse-Deterrent
products</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H99C96AB349AA4642BA8A0CEB414698FD" section-type="subsequent-section"><enum>1123.</enum><header display-inline="yes-display-inline">Optimizing global clinical
trials</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="H0D148BE21DDA45CD869421E225304B13" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HCB1BA97D8052442EB4A4EA6C49CACB04" section-type="subsequent-section"><enum>569A.</enum><header display-inline="yes-display-inline">Optimizing global clinical trials</header>
<subsection commented="no" display-inline="no-display-inline" id="H2607A34F15A3430285EEFA8E6C51AD54"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HBBA1809B0EE4454CBD36FACAB281DF6C"><enum>(1)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1E2D5F3606084256B17F04918A81352A"><enum>(2)</enum><text display-inline="yes-display-inline">enhance the commitment to provide
consistent parallel scientific advice to manufacturers seeking simultaneous
global development of new medical products in order to—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H7B9D433EB7944FAB9657B135B69DA366"><enum>(A)</enum><text display-inline="yes-display-inline">enhance medical product development;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAE34F8D6454F4590822E8028C7098024"><enum>(B)</enum><text display-inline="yes-display-inline">facilitate the use of foreign data;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF61A687E4AF840A6B7AB3C5465328727"><enum>(C)</enum><text display-inline="yes-display-inline">minimize the need to conduct duplicative
clinical studies, preclinical studies, or nonclinical studies.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF693CE42CFBA4738B1CF4595DE0BAA4C"><enum>(b)</enum><header display-inline="yes-display-inline">Medical product</header><text display-inline="yes-display-inline">In this section, the term <term>medical
product</term> 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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HEC4A10203E2B4417AC881EDA5944319B"><enum>(c)</enum><header display-inline="yes-display-inline">Savings
clause</header><text display-inline="yes-display-inline">Nothing in this
section shall alter the criteria for evaluating the safety or effectiveness of
a medical product under this Act.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H8024C92EB84249B592139B1ACBE307A3" section-type="subsequent-section"><enum>569B.</enum><header display-inline="yes-display-inline">Use of clinical investigation data from
outside the United States</header>
<subsection commented="no" display-inline="no-display-inline" id="H9EDDECB99C5C4A29A416E80581395D7A"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HAD504282030347F88E65F214967B56C4"><enum>(b)</enum><header display-inline="yes-display-inline">Notice to sponsor</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H017E1935DE084A3AAFA5D8706FDA89E2" section-type="subsequent-section"><enum>1124.</enum><header display-inline="yes-display-inline">Advancing regulatory science to promote
public health innovation</header>
<subsection commented="no" display-inline="no-display-inline" id="H1A74106E79D34AECBC3FB34981AEE24C"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 <quote>Secretary</quote>) 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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HB188435A337C4F2593C837BFE6D1F622"><enum>(b)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H6B03A30C1E284563B83E327E274A4BB4"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF3521068C1F54032B366D68F481509B7"><enum>(2)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5B8A126914774AF8A546B2372320C578"><enum>(3)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H782C076595584EA0B83B78776F692D9A"><enum>(4)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0BA5A50AA33D474EB4F5BD098EEFA465"><enum>(5)</enum><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HE53D2A0A64A546A1BF2D0056FA5B245E"><enum>(A)</enum><text display-inline="yes-display-inline">development, updating, and consistent
application of guidance documents that support medical product decisionmaking;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE96D7F31E9C94C91941688DB9DB50774"><enum>(B)</enum><text display-inline="yes-display-inline">adoption of the tools, methods, and
processes under section 566 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb–5).</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HC0FA29100A314F89B084126D64FE8E33"><enum>(c)</enum><header display-inline="yes-display-inline">Performance reports</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H8EC3A3D996954995B94B2B321290BB70"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB2599A8557C14D1FAE99AD8D27C287BE"><enum>(2)</enum><text display-inline="yes-display-inline">the integration and adoption of advances in
regulatory science as set forth in paragraph (5) of such subsection; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB8BF81E546F54E64AD20B6FAC4544682"><enum>(3)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H11FCFDEBF4FD4FFE9FC0926439FDEAAA"><enum>(d)</enum><header display-inline="yes-display-inline">Medical product</header><text display-inline="yes-display-inline">In this section, the term <term>medical
product</term> 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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HCBE6DE5A7B204184822B39661051BC89" section-type="subsequent-section"><enum>1125.</enum><header display-inline="yes-display-inline">Information technology</header>
<subsection commented="no" display-inline="no-display-inline" id="H6C66B96127CD4C32A079FDA0D4EA5BDD"><enum>(a)</enum><header display-inline="yes-display-inline">HHS report</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H497C920CA0DB4C89913234DF24913B07"><enum>(1)</enum><text display-inline="yes-display-inline">report to Congress on—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H2843C632EE6F45B69F20FFE0EAB19201"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF682215EA60640C98C76CC1C1B8C1730"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC1A5811F5ADE4562A8927704A62A115F"><enum>(C)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD8605718EA244F629BB27E1DFF6EA736"><enum>(D)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9EABE777829147DB84814D7D412B1CBC"><enum>(2)</enum><text display-inline="yes-display-inline">develop—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H26595DBDB6C24766AB61CB82C1B0D528"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H08210D0F4B4B490F89F1263AAFC2A9DE"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HCB2B2984A2C24D89B92A87B0AD572DD6"><enum>(b)</enum><header display-inline="yes-display-inline">GAO report</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HFAEC06711F6F4D30A06B30F18D9F3437"><enum>(1)</enum><text display-inline="yes-display-inline">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);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H945E92A01ED745F99399CC7E6EA8B6DD"><enum>(2)</enum><text display-inline="yes-display-inline">the effectiveness of the comprehensive
information technology strategic plan described in subsection (a)(1)(A),
including the results-oriented goals and performance measures; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA163F1D5477540A88AB76098F5B56569"><enum>(3)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H28F66553D6DA48F299713DF36461CD67" section-type="subsequent-section"><enum>1126.</enum><header display-inline="yes-display-inline">Nanotechnology</header>
<subsection commented="no" display-inline="no-display-inline" id="H3D4F5300CC82407A8B20DD8FCB186CFA"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services
(referred to in this section as the <quote>Secretary</quote>) 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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HD83A74A9E15342D290B6E0E4E35B2A33"><enum>(b)</enum><header display-inline="yes-display-inline">Activities</header><text display-inline="yes-display-inline">In conducting activities related to
nanotechnology, the Secretary may—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H4E3773FB81D1445095C5DC7C756E2E2A"><enum>(1)</enum><text display-inline="yes-display-inline">assess scientific literature and data on
general nanomaterials interactions with biological systems and on specific
nanomaterials of concern to the Food and Drug Administration;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H671D30F110CA431B8D08ABE9FB0643D7"><enum>(2)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB6B7E4CD1FB74B5584D53990640CB10B"><enum>(3)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H8D87788BBE8A49A7B647A7D12C16B56D"><enum>(4)</enum><text display-inline="yes-display-inline">promote and participate in collaborative
efforts to further the understanding of measurement and detection methods for
nanomaterials;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF543BECDB9D047BCBF25E5E92A7F6FE5"><enum>(5)</enum><text display-inline="yes-display-inline">collect, synthesize, interpret, and
disseminate scientific information and data related to the interactions of
nanomaterials with biological systems;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HAFEB629D3AA64D149102F3E1D73DDBF5"><enum>(6)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H19D0A9F647AA453A8939B147188BE884"><enum>(7)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HCFD8B4BD5FE7409D87A546D59E24F4FC"><enum>(8)</enum><text display-inline="yes-display-inline">encourage the Food and Drug Administration
to participate in international and national consensus standards activities
pertaining to nanomaterials; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDBB937274D6F40FCAAA8A00D4919104A"><enum>(9)</enum><text display-inline="yes-display-inline">carry out other activities that the
Secretary determines are necessary and consistent with the purposes described
in paragraphs (1) through (8).</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H698F660A98DC4F7DB794D1C544AE1346" section-type="subsequent-section"><enum>1127.</enum><header display-inline="yes-display-inline">Online pharmacy report to
Congress</header><text display-inline="no-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H9F62C22A877146F0AB01CB9EF7669E46"><enum>(1)</enum><text display-inline="yes-display-inline">the methods by which Internet Web sites are
used to sell prescription drugs in violation of Federal or State law or
established industry standards;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H059DB81BA80D4B2C9EF0B219EC40058A"><enum>(2)</enum><text display-inline="yes-display-inline">the harmful health effects that patients
experience when they consume prescription drugs purchased through such pharmacy
Internet Web sites;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5F89E5A19FA34FC4B24B91C4155A8817"><enum>(3)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFB08318B90E5464F9DBD6052058CDB62"><enum>(4)</enum><text display-inline="yes-display-inline">the level of success that Federal, State,
and local governments have experienced in investigating and prosecuting such
cases;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H92D28EB178F84D5FB989F31CFD598875"><enum>(5)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H06BBB3294EFB455EADECDD7CE7E14BC9"><enum>(6)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB5FC6BEE6C81435AB56E9A175229A731"><enum>(7)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9BE03BBBA5C0404FBAA9AE237991FCFD"><enum>(8)</enum><text display-inline="yes-display-inline">activities that private sector actors are
taking to address the prevalence of illegitimate pharmacy Internet Web sites,
and any policies to encourage further activities.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H1C30F15716D846EBB124561CA4A78147" section-type="subsequent-section"><enum>1128.</enum><header display-inline="yes-display-inline">Report on small businesses</header><text display-inline="no-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H22F0BC5B985F46F48FBBABF287F5B9DC"><enum>(1)</enum><text display-inline="yes-display-inline">a listing of and staffing levels of all
small business offices at the Food and Drug Administration, including the small
business liaison program;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HCC45CBECC1CA4465AAE579A061B077B1"><enum>(2)</enum><text display-inline="yes-display-inline">the status of partnership efforts between
the Food and Drug Administration and the Small Business Administration;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2E977CCA8EA84645A808E425276432DF"><enum>(3)</enum><text display-inline="yes-display-inline">a summary of outreach efforts to small
businesses and small business associations, including availability of toll-free
telephone help lines;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H50FA0CBD1B8E41BC8E07CA129F876F9A"><enum>(4)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBBAECF0400AD45CCB4C8CC3E45F59BC1"><enum>(5)</enum><text display-inline="yes-display-inline">the number of small businesses submitting
applications and receiving approval for unsolicited grant applications from the
Food and Drug Administration;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7A06CB0F79D94D16A69239489C3BD434"><enum>(6)</enum><text display-inline="yes-display-inline">the number of small businesses submitting
applications and receiving approval for solicited grant applications from the
Food and Drug Administration; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H74397E43D1604F40BB10C279D8222797"><enum>(7)</enum><text display-inline="yes-display-inline">barriers small businesses encounter in the
drug and medical device approval process.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H6EDFF116E55B4D0998027A60177EAD36" section-type="subsequent-section"><enum>1129.</enum><header display-inline="yes-display-inline">Protections for the commissioned corps of
the public health service act</header>
<subsection commented="no" display-inline="no-display-inline" id="H591DFB02FED4440F89A090E9BDBD5B96"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 221(a) of the Public Health Service
Act (42 U.S.C. 213a(a)) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HBDDD31B29E7646328EC6560E0E17F9F8" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H52F5DB93A6BC41228DFEDF966DBEBAED"><enum>(18)</enum><text display-inline="yes-display-inline">Section 1034, Protected Communications;
Prohibition of Retaliatory Personnel
Actions.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H150DA56CE2E147D1AB552201FD15277E"><enum>(b)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">Section 221(b) of the Public Health Service
Act (42 U.S.C. 213a(b)) is amended by adding at the end the following:
<quote>For purposes of paragraph (18) of subsection (a), the term
<term>Inspector General</term> in section 1034 of such title 10 shall mean the
Inspector General of the Department of Health and Human
Services.</quote>.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H44B80560214F48B38AEEA52E4458B990" section-type="subsequent-section"><enum>1130.</enum><header display-inline="yes-display-inline">Compliance date for rule relating to
sunscreen drug products for over-the-counter human use</header><text display-inline="no-display-inline">In accordance with the final rule issued by
the Commissioner of Food and Drug entitled <quote>Labeling and Effectiveness
Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of
Compliance Dates</quote> (77 Fed. Reg. 27591 (May 11, 2012)), a product subject
to the final rule issued by the Commissioner entitled <quote>Labeling and
Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human
Use</quote> (76 Fed. Reg. 35620 (June 17, 2011)), shall comply with such rule
not later than—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HBE40B008D7874A6C974D2E5BA7CE8C2A"><enum>(1)</enum><text display-inline="yes-display-inline">December 17, 2013, for products subject to
such rule with annual sales of less than $25,000 and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFFF94935634A481C89F5051C4EA09018"><enum>(2)</enum><text display-inline="yes-display-inline">December 17, 2012, for all other products
subject to such rule.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="HF1602C2D8204480CA1E430AC0A17FAA3" section-type="subsequent-section"><enum>1131.</enum><header display-inline="yes-display-inline">Strategic integrated management
plan</header><text display-inline="no-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HFE9FF196CC5F46789F6E2E62D77506D7"><enum>(1)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4C5D5083D62C49649D3DA69192DAE5DE"><enum>(2)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB9ABF96593A84ADE9BE85AAB03CB1BCC"><enum>(3)</enum><text display-inline="yes-display-inline">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.).</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H3A42DC4600F845269C03490F148D7038" section-type="subsequent-section"><enum>1132.</enum><header display-inline="yes-display-inline">Assessment and modification of
REMS</header>
<subsection commented="no" display-inline="no-display-inline" id="HA211CF94DC6847699C5EF1AC384B0633"><enum>(a)</enum><header display-inline="yes-display-inline">Assessment and modification of approved
strategy</header><text display-inline="yes-display-inline">Section 505–1(g) (21
U.S.C. 355–1(g)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HC6CB1F24AA6E442385272A7E7838057A"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>, and
propose a modification to,</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB26F8826AD9B4F9AB4BFDFC0AF8089DB"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HC154E30A007A43149A103421D4799169"><enum>(A)</enum><text display-inline="yes-display-inline">in the matter before subparagraph
(A)—</text>
<clause commented="no" display-inline="no-display-inline" id="HA5AB5DA741AA40FD92B180D57D9A5CF2"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>, subject to paragraph
(5),</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H3215DFCB8E7C49C78326FB08C96A0048"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>, and may propose a
modification to,</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HCC6DC69BAFAD4F1395C1246D6DB68F9C"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (C), by striking <quote>new
safety or effectiveness information indicates that</quote> and all that follows
and inserting the following:</text>
<quoted-block display-inline="yes-display-inline" id="H8631C3A8C6B84B66844736E3E8BA19AF" style="OLC">
<text>an assessment is
needed to evaluate whether the approved strategy should be modified
to—</text><clause commented="no" display-inline="no-display-inline" id="H0905EFEC3E2F4962991116FC14E3A25C"><enum>(i)</enum><text display-inline="yes-display-inline">ensure the benefits of the drug outweigh
the risks of the drug; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H775E24FC2355414D9D5EACA13A868B54"><enum>(ii)</enum><text display-inline="yes-display-inline">minimize the burden on the health care
delivery system of complying with the
strategy.</text>
</clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9410284FA6B64DAB9F366AE3649D28B2"><enum>(C)</enum><text display-inline="yes-display-inline">by striking subparagraph (D);</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD7754B048E354354970AD4CC2E14ECE6"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (3), by striking <quote>for a
drug shall include—</quote> and all that follows and inserting the following
<quote>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.</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H96DC3F9DA261457D93A40BAB469A6D7C"><enum>(4)</enum><text display-inline="yes-display-inline">by amending paragraph (4) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="H3B4260373BA04BF08F53F31DCF6EBAB0" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="HBADCBEFB0A6C4139B48A5203386A4DC0"><enum>(4)</enum><header display-inline="yes-display-inline">Modification</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H56829018182545DAA66FAEA332C02DAD"><enum>(A)</enum><header display-inline="yes-display-inline">On initiative of responsible
person</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC549CD8692664557BA86F59D1827EB4F"><enum>(B)</enum><header display-inline="yes-display-inline">On initiative of Secretary</header><text display-inline="yes-display-inline">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—</text>
<clause commented="no" display-inline="no-display-inline" id="HD9388CA36BF54CC995290924C0522C12"><enum>(i)</enum><text display-inline="yes-display-inline">ensure the benefits of the drug outweigh
the risks of the drug; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HA57544E292104A03BB11B5E50A271397"><enum>(ii)</enum><text display-inline="yes-display-inline">minimize the burden on the health care
delivery system of complying with the
strategy.</text>
</clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H41B6DE185A8F4BF1AD22104E3FACCE9D"><enum>(b)</enum><header display-inline="yes-display-inline">Review of proposed strategies; review of
assessments and modifications of approved strategies</header><text display-inline="yes-display-inline">Section 505–1(h) (21 U.S.C. 355–1(h)) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H6D6AFFCD963340EBAC17D02B1CFBD65A"><enum>(1)</enum><text display-inline="yes-display-inline">in the subsection heading by inserting
<quote><header-in-text level="subsection" style="OLC">and
Modifications</header-in-text></quote> after <quote><header-in-text level="subsection" style="OLC">Review of
Assessments</header-in-text></quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H54B12A0447CA40B8ADC155CB9A20D491"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HEE8008A0D3454A2C9F5E704F7A088C90"><enum>(A)</enum><text display-inline="yes-display-inline">by inserting <quote>and proposed
modification to</quote> after <quote>under subsection (a) and each assessment
of</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H70AE416CD1D945F18677894B06638DB3"><enum>(B)</enum><text display-inline="yes-display-inline">by inserting <quote>, and, if necessary,
promptly initiate discussions with the responsible person about such proposed
strategy, assessment, or modification</quote> after <quote>subsection
(g)</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEA980A26EFAE460C888A9CD129EB5D1D"><enum>(3)</enum><text display-inline="yes-display-inline">by striking paragraph (2);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1161EC7162B7438C9A7AC8A2E0BC4532"><enum>(4)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (3) through (9)
as paragraphs (2) through (8), respectively;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC41765DD31EA432D92940ECFC4DE77F5"><enum>(5)</enum><text display-inline="yes-display-inline">in paragraph (2), as redesignated by
paragraph (4)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H1C6CA8B47C294340BBBEA3BE8B1EA7B6"><enum>(A)</enum><text display-inline="yes-display-inline">by amending subparagraph (A) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="HEB1010E74C1345DCA7B98F5D406880B6" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="HE6607100013147129F0934A937284013"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header>
<clause commented="no" display-inline="no-display-inline" id="H300281CE92D24457A389CB2225EE4334"><enum>(i)</enum><header display-inline="yes-display-inline">Timeframe</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H56E7E51D75A6433FB3E410C21512EEAF"><enum>(ii)</enum><header display-inline="yes-display-inline">Minor modifications</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H0BF6FE55D77246D7B4D6FDC93A14FE66"><enum>(iii)</enum><header display-inline="yes-display-inline">REMS modification due to safety label
changes</header><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HC67F24BBC2514B67BED0F6DEF4A162A3"><enum>(iv)</enum><header display-inline="yes-display-inline">Guidance</header><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H133575D3880443D6A2D56B161B7CEA5A"><enum>(B)</enum><text display-inline="yes-display-inline">by amending subparagraph (C) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="H3CA09225ACF0404D8C153326AF685E29" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H1B280976D6A04F95896EF0C4BC160F82"><enum>(C)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">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).</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5657EF4E740A4AFB90056EB09A73B6A2"><enum>(6)</enum><text display-inline="yes-display-inline">in paragraph (4), as redesignated by
paragraph (4)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H6AE09A7F34D74993BCAFD7B5956A17F1"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A)(i)—</text>
<clause commented="no" display-inline="no-display-inline" id="HED4C87C00C9D45A881D7A598916C233E"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>Not earlier than 15
days, and not later than 35 days, after discussions under paragraph (2) have
begun, the</quote> and inserting <quote>The</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HE6CF6E249B37457B8C6DB147A1DFD3A7"><enum>(ii)</enum><text display-inline="yes-display-inline">by inserting <quote>, after the sponsor is
required to make a submission under subsection (a)(2) or (g),</quote> before
<quote>request in writing</quote>; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6CAA8E989DC04478A82BA9667FCDB8DB"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (I)—</text>
<clause commented="no" display-inline="no-display-inline" id="HEE9B7F3C1D244367AA33249ABAEEBCFC"><enum>(i)</enum><text display-inline="yes-display-inline">by striking clauses (i) and (ii);
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H3B2A0BF3BF774487AF5F18EBF8A23BB5"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>if the
Secretary—</quote> and inserting <quote>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.</quote>;</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H171AFF3239CA4CF9AA212AC159AAC137"><enum>(7)</enum><text display-inline="yes-display-inline">in paragraph (5), as redesignated by
paragraph (4)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HC70A4D3957B444909317294BD104B4BB"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking <quote>any
of subparagraphs (B) through (D)</quote> and inserting <quote>subparagraph (B)
or (C)</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0164F41C67A94D38A3F29E861C978F34"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (C), by striking
<quote>paragraph (4) or (5)</quote> and inserting <quote>paragraph (3) or
(4)</quote>; and</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H8C13FFF4014A416C8B0E8E02A8D5EB2B"><enum>(8)</enum><text display-inline="yes-display-inline">in paragraph (8), as redesignated by
paragraph (4), by striking <quote>paragraphs (7) and (8)</quote> and inserting
<quote>paragraphs (6) and (7).</quote>.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H8217E955432E4DE0A79CE025CE8EBC96"><enum>(c)</enum><header display-inline="yes-display-inline">Guidance</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HA405E4C847864311ADA60980478621CA" section-type="subsequent-section"><enum>1133.</enum><header display-inline="yes-display-inline">Extension of period for first applicant to
obtain tentative approval without forfeiting 180-day-exclusivity
period</header>
<subsection commented="no" display-inline="no-display-inline" id="H41F219F256E54AF8A395C31F15F25ED6"><enum>(a)</enum><header display-inline="yes-display-inline">Extension</header>
<paragraph commented="no" display-inline="no-display-inline" id="HA6D488C1F9C2460789B89D7111F71CC6"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 <quote>30 months</quote> in paragraph (5)(D)(i)(IV)
of such section shall, with respect to such application, be read as
meaning—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H617974E40E3F49638D0B50A081001A73"><enum>(A)</enum><text display-inline="yes-display-inline">during the period beginning on the date of
enactment of this Act, and ending on September 30, 2015, <quote>40
months</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7A3318FD8571499A99097E2CA9E608F8"><enum>(B)</enum><text display-inline="yes-display-inline">during the period beginning on October 1,
2015, and ending on September 30, 2016, <quote>36 months</quote>.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDDE86A165996436BBA1901FA56FE1587"><enum>(2)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H6238817AB8BF4E769AC9162674989E1B"><enum>(b)</enum><header display-inline="yes-display-inline">Period for obtaining tentative approval of
certain applications</header><text display-inline="yes-display-inline">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).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HA2DD3ED1C3D041B28F25CBA71577E75B"><enum>(c)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">For the purposes of this section, the terms
<quote>application</quote> and <quote>first applicant</quote> 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)).</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H9081DFB0A0224B698FF4270D1CF09CF7" section-type="subsequent-section"><enum>1134.</enum><header display-inline="yes-display-inline">Deadline for determination on certain
petitions</header>
<subsection commented="no" display-inline="no-display-inline" id="HCFEAF5A2D992438F9ECA5368623C937F"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 505 (21 U.S.C. 355) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H20BAD1757D744609BE264AADED1EE1C8" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H3F1CCE9F259E48E1BA0BADC2D7AD4F8A"><enum>(w)</enum><header display-inline="yes-display-inline">Deadline for determination on certain
petitions</header><text display-inline="yes-display-inline">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.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H16F7507EB4F142EA9BFF1D48192C5D82"><enum>(b)</enum><header display-inline="yes-display-inline">Application</header><text display-inline="yes-display-inline">The amendment made by
<internal-xref idref="HCFEAF5A2D992438F9ECA5368623C937F" legis-path="__.(a)">subsection (a)</internal-xref> 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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H523B51274351410487E84D8507E1B9B0" section-type="subsequent-section"><enum>1135.</enum><header display-inline="yes-display-inline">Final agency action relating to petitions
and civil actions</header><text display-inline="no-display-inline">Section
505(q) (21 U.S.C. 355(q)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HDAE42C161DF743909F99AFDE8430EEE9"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HB526F2F4B0BC4D42A606469E2ABADB9F"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking
<quote>subsection (b)(2) or (j)</quote> and inserting <quote>subsection (b)(2)
or (j) of this section or section 351(k) of the Public Health Service
Act</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H513DAC7DA38B49258ECEEDB14603A690"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (F), by striking <quote>180
days</quote> and inserting <quote>150 days</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2C555472D96041968C61076CB5C0B2E0"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2)(A)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HF70971F8AFBA409197B63828D18D6619"><enum>(A)</enum><text display-inline="yes-display-inline">in the subparagraph heading, by striking
<quote><header-in-text level="subparagraph" style="OLC">180</header-in-text></quote> and inserting <quote><header-in-text level="subparagraph" style="OLC">150</header-in-text></quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H992BE4AD7D134A9D9847F51E3FDA5774"><enum>(B)</enum><text display-inline="yes-display-inline">in clause (i), by striking
<quote>180-day</quote> and inserting <quote>150-day</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDDA0A7ADDDB0440F854A80D8FFA9FFBB"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H61B5E0C4C7B64A3E96B3FBCD6D0280C5"><enum>(A)</enum><text display-inline="yes-display-inline">by redesignating subparagraphs (A) and (B)
as clauses (i) and (ii), respectively, and moving such clauses, as so
redesignated, 2 ems to the right;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H39B234781A6C46E2867062D23E7BE92B"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>This subsection does not
apply to—</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="H0066C15ACCCF4339A93FDBBDED6C9068" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="HF0979AEF42E542D697E70413C2C1CE41"><enum>(A)</enum><text display-inline="yes-display-inline">This subsection does not apply
to—</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD658CFD160384E148F46656C7041967D"><enum>(C)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HB4983BF558B7425695D2AFA6D8ADA3ED" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="H3B4F02AD1BE44DAB8FAD138A41114CF7"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2E67FD4A4E6A49E7906D9006F43B89F2"><enum>(4)</enum><text display-inline="yes-display-inline">in paragraph (5), by striking
<quote>subsection (b)(2) or (j)</quote> inserting <quote>subsection (b)(2) or
(j) of the Act or 351(k) of the Public Health Service Act</quote>.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H357DD5E426E94AE28130A4EF0F586087" section-type="subsequent-section"><enum>1136.</enum><header display-inline="yes-display-inline">Electronic submission of
applications</header><text display-inline="no-display-inline">Subchapter D of
chapter VII (21 U.S.C. 379k et seq.) is amended by inserting after section 745
the following:</text>
<quoted-block display-inline="no-display-inline" id="H36DF4CB56A604787BAA2C5E9370CB533" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HDB27E72427494893810FB19198760508" section-type="subsequent-section"><enum>745A.</enum><header display-inline="yes-display-inline">Electronic format for submissions</header>
<subsection commented="no" display-inline="no-display-inline" id="HD2340FACDC31438C876833BB0C89CE71"><enum>(a)</enum><header display-inline="yes-display-inline">Drugs and biologics</header>
<paragraph commented="no" display-inline="no-display-inline" id="H5ACDF83C83F44C74B6EFF8FF0DE00445"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H8F612E484BF448F78C74C9A513789BD6"><enum>(2)</enum><header display-inline="yes-display-inline">Guidance contents</header><text display-inline="yes-display-inline">In the guidance under
<internal-xref idref="H5ACDF83C83F44C74B6EFF8FF0DE00445" legis-path="745A.(a)(1)">paragraph (1)</internal-xref>, the Secretary
may—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H302BE74A943C4DBFA80510DECF27A28E"><enum>(A)</enum><text display-inline="yes-display-inline">provide a timetable for establishment by
the Secretary of further standards for electronic submission as required by
such paragraph; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEE77B84F22D64E13B7D27CE23A8DBF97"><enum>(B)</enum><text display-inline="yes-display-inline">set forth criteria for waivers of and
exemptions from the requirements of this subsection.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1C582DDEFA074ADC95D1A45ABC81BC79"><enum>(3)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">This subsection shall not apply to
submissions described in section 561.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H4723973679BF49B197F4E0231AC0CC5F"><enum>(b)</enum><header display-inline="yes-display-inline">Devices</header>
<paragraph commented="no" display-inline="no-display-inline" id="H7756524B78E04FA9BC894C13FEC4B389"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0366E67F65CA499196541D663E8004B6"><enum>(2)</enum><header display-inline="yes-display-inline">Guidance contents</header><text display-inline="yes-display-inline">In the guidance under
<internal-xref idref="H7756524B78E04FA9BC894C13FEC4B389" legis-path="745A.(b)(1)">paragraph (1)</internal-xref>, the Secretary
may—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H43F6EC76918040DD914487C94988D326"><enum>(A)</enum><text display-inline="yes-display-inline">provide standards for the electronic copy
required under such paragraph; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA1E8979BFE1747F39DC22E2DDC4D82D5"><enum>(B)</enum><text display-inline="yes-display-inline">set forth criteria for waivers of and
exemptions from the requirements of this
subsection.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H766D91D55CED456F8046515E703F905A" section-type="subsequent-section"><enum>1137.</enum><header display-inline="yes-display-inline">Patient participation in medical product
discussions</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="HB9A9A64CF60D4889AEE1DABDA98AF8E5" style="OLC">
<section commented="no" display-inline="no-display-inline" id="HEF48D0DDC4B84F8F80637A0C03BB519F" section-type="subsequent-section"><enum>569C.</enum><header display-inline="yes-display-inline">Patient participation in medical product
discussion</header>
<subsection commented="no" display-inline="no-display-inline" id="H7245CFA4AF2A4AA996D6A0BA587F2A25"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HF3B99EDBC12246149D8049D603C7F9C8"><enum>(1)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF88B304EE51040CEA64219E939D1DE80"><enum>(2)</enum><text display-inline="yes-display-inline">exploring means to provide for
identification of patient representatives who do not have any, or have minimal,
financial interests in the medical products industry.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H1A176820052C4103AC9A4C943068A978"><enum>(b)</enum><header display-inline="yes-display-inline">Protection of proprietary
information</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HF7C653D20E954D9299827DA5A248ADBA"><enum>(c)</enum><header display-inline="yes-display-inline">Other consultation</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H6747CD98B9A14056B79B853F95D350A0"><enum>(d)</enum><header display-inline="yes-display-inline">No right or obligation</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HD924A5660CA447D489B3CA3970759CF5"><enum>(e)</enum><header display-inline="yes-display-inline">Financial interest</header><text display-inline="yes-display-inline">In this section, the term <term>financial
interest</term> means a financial interest under section 208(a) of title 18,
United States
Code.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H16427B5E14EB44798FF2877E2A689EA8" section-type="subsequent-section"><enum>1138.</enum><header display-inline="yes-display-inline">Ensuring adequate information regarding
pharmaceuticals for all populations, particularly underrepresented
subpopulations, including racial subgroups</header>
<subsection commented="no" display-inline="no-display-inline" id="HEEEF97B223DF4B8A83139D7DFF9E4DCA"><enum>(a)</enum><header display-inline="yes-display-inline">Communication plan</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services
(referred to in this section as the <quote>Secretary</quote>), 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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HC7ED231092CB49BD8BAF8EF7E3377087"><enum>(b)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">The communication plan described under
subsection (a)—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HD2062D39A220426E879DC543A14C77C8"><enum>(1)</enum><text display-inline="yes-display-inline">shall take into account—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HA992E138387A410FA3AD87049BBA8423"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4B816DFCC2D9471BB7F8DB20979F8CA5"><enum>(B)</enum><text display-inline="yes-display-inline">the nature of the medical product;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HFA5CB49EB8C94992B6F01AD6EF8C4D37"><enum>(C)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H14EE7DF970A64AADBE7093887D569D53"><enum>(2)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4C1E67B1017E4C62A71BA6CD350FA9A1"><enum>(3)</enum><text display-inline="yes-display-inline">shall include a process for implementation
of any improvements or other modifications determined to be necessary.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H7404EB091B464A69B8E6D3687AF2E367"><enum>(c)</enum><header display-inline="yes-display-inline">Issuance and posting of communication
plan</header>
<paragraph commented="no" display-inline="no-display-inline" id="HC549715539C14580BAD8EF260C25597E"><enum>(1)</enum><header display-inline="yes-display-inline">Communication plan</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF83764500E094FE38B904832B325316C"><enum>(2)</enum><header display-inline="yes-display-inline">Posting of communication plan on the Office
of Minority Health Web site</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H86BD9587792948A8B4820DD8474AEA7A" section-type="subsequent-section"><enum>1139.</enum><header display-inline="yes-display-inline">Scheduling of hydrocodone</header>
<subsection commented="no" display-inline="no-display-inline" id="H84059DCAB9CA4203BAC36AEF2F3A5B53"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 <quote>Secretary</quote>) 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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H3B2CFDC901654DF095B83B2A0439E1A3"><enum>(b)</enum><header display-inline="yes-display-inline">Stakeholder input</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H67FAF00F5F224CFC8F630364DAAAAD83"><enum>(c)</enum><header display-inline="yes-display-inline">Transcript</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H21651AFCBC1E464AA3BBC6ABD337607F" section-type="subsequent-section"><enum>1140.</enum><header display-inline="yes-display-inline">Study on Drug Labeling by Electronic
Means</header>
<subsection commented="no" display-inline="no-display-inline" id="H4F452D521F3342B2AF9BC90C76BAABC5"><enum>(a)</enum><header display-inline="yes-display-inline">Study</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H11F5BAF5B35F476DBB0C9BE3F59574AF"><enum>(b)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">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).</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HADA6DF9855B3444B9FAA03CAC45CE4C6" section-type="subsequent-section"><enum>1141.</enum><header display-inline="yes-display-inline">Recommendations on interoperability
standards</header>
<subsection commented="no" display-inline="no-display-inline" id="HAA001E9C734442ADBADA5B21602B3F9B"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H0CC35001DF664A9382A0B498E2A21764"><enum>(1)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H147E3097F31E4AD094F38172F3C7EF84"><enum>(2)</enum><text display-inline="yes-display-inline">the Controlled Substance Monitoring Program
established under section 399O of the Public Health Service Act (42 U.S.C.
280g–3).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HB5FA0C7670FB4AFDB8BDF545149761E4"><enum>(b)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">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)—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HCCB6A135908A4FA58B8EE90F1AB3819B"><enum>(1)</enum><text display-inline="yes-display-inline">open standards that are freely available,
without cost and without restriction, in order to promote broad
implementation;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H199D5AAF852341A398EED0E56969269F"><enum>(2)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H18F4F82EDAD44BE891704AC42FAE57CF"><enum>(3)</enum><text display-inline="yes-display-inline">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;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE487EE7610854659A5D8E3FC662CB4D0"><enum>(4)</enum><text display-inline="yes-display-inline">access control methodologies to share
protected information solely in accordance with State laws and regulations;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H53557B8B5ACB4FF1A6CFA49F8CAB780E"><enum>(5)</enum><text display-inline="yes-display-inline">consider model interoperability standards
developed by the Alliance of States with Prescription Monitoring
Programs.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H0C18F5358BA449CBB0828FA0826158E2"><enum>(c)</enum><header display-inline="yes-display-inline">Report</header>
<paragraph commented="no" display-inline="no-display-inline" id="H34BD2E30E963488BB60AE9D9067469F2"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5155A38B2EFB468CB0DB1DAFD2675CE6"><enum>(2)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">The report required under paragraph (1)
shall include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="HF348D7AF8AAE4864BA514A6F43BCBB46"><enum>(A)</enum><text display-inline="yes-display-inline">an assessment of legal, technical, fiscal,
privacy, or security challenges that have an impact on interoperability;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HCEBECF4BE6404E7B867DC8CFC3B6E4C1"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6BC1E89DF7D240F8980C78026B66DF2A"><enum>(C)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7161DF2406F8438BA326D132A4B8AD57"><enum>(D)</enum><text display-inline="yes-display-inline">an assessment of the extent to which
providers use prescription drug management programs in delivering care and
preventing prescription drug abuse.</text>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="HFA4CC1741E044222BBC08CC634459D14" section-type="subsequent-section"><enum>1142.</enum><header display-inline="yes-display-inline">Conflicts of interest</header>
<subsection commented="no" display-inline="no-display-inline" id="HFCF5EFF6ED554337B38D6FC9B356B011"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 712 (21 U.S.C. 379d–1) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H5747415DBAB447A280C48504C8B647CC"><enum>(1)</enum><text display-inline="yes-display-inline">by striking subsections (b) and (c) and
inserting the following subsections:</text>
<quoted-block display-inline="no-display-inline" id="HD95462C736F7416DA89F0EAC110FD780" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H6EA889D01F414DEB81432E9FA1D95456"><enum>(b)</enum><header display-inline="yes-display-inline">Recruitment for advisory
committees</header>
<paragraph commented="no" display-inline="no-display-inline" id="HC5FDD320103B4943B636BC5249A41E37"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H9D4443D44B764F76A63951DD9FF4C068"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBB99BB2E391F48F59ABB411A72E8C686"><enum>(B)</enum><text display-inline="yes-display-inline">seek input from professional medical and
scientific societies to determine the most effective informational and
recruitment activities;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE172C23F1EF64FEF8A17CAB5D23F04C6"><enum>(C)</enum><text display-inline="yes-display-inline">at least every 180 days, request referrals
for potential members of advisory committees from a variety of stakeholders,
including—</text>
<clause commented="no" display-inline="no-display-inline" id="H975D2A9D9E0C46EFB8A992FA004FD405"><enum>(i)</enum><text display-inline="yes-display-inline">product developers, patient groups, and
disease advocacy organizations; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H5348CA312F114B4BA230344824ACCA2C"><enum>(ii)</enum><text display-inline="yes-display-inline">relevant—</text>
<subclause commented="no" display-inline="no-display-inline" id="H80798758BD464D2EA4CAF2E36C0F6644"><enum>(I)</enum><text display-inline="yes-display-inline">professional societies;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H04EC34E3FFBF4D59A7F48DB43193FFF2"><enum>(II)</enum><text display-inline="yes-display-inline">medical societies;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="HD83D56A73BB64ADB9EE76B366EA29E0E"><enum>(III)</enum><text display-inline="yes-display-inline">academic organizations; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="H1A2A550D1AB2465CBC38EEE1F4EF7A45"><enum>(IV)</enum><text display-inline="yes-display-inline">governmental organizations; and</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD70D8045510B43E88C8C70B38E62CC41"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5AEF6A91BC854B518CA6E797A5824F69"><enum>(2)</enum><header display-inline="yes-display-inline">Recruitment activities</header><text display-inline="yes-display-inline">The recruitment activities under paragraph
(1) may include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H0E423ABF4CC64965BE043E5FD11D3CFE"><enum>(A)</enum><text display-inline="yes-display-inline">advertising the process for becoming an
advisory committee member at medical and scientific society conferences;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEB40BCD321CF4B3B8F1F74262A1FC771"><enum>(B)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAA6B37B9D00443218D9C55D4F0D2B64F"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB3616D3F1AF84FE297AFCC0931AE55BD"><enum>(3)</enum><header display-inline="yes-display-inline">Expertise</header><text display-inline="yes-display-inline">In carrying out this subsection, the
Secretary shall seek to ensure that the Secretary has access to the most
current expert advice.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H515ABFF5D33140C8B582F225CC96CBFE"><enum>(c)</enum><header display-inline="yes-display-inline">Disclosure of determinations and
certifications</header><text display-inline="yes-display-inline">Notwithstanding section 107(a)(2) of the
Ethics in Government Act of 1978, the following shall apply:</text>
<paragraph commented="no" display-inline="no-display-inline" id="H027EB435CA6E484ABB099B4A006A2914"><enum>(1)</enum><header display-inline="yes-display-inline">15 or more days in advance</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H9C25C28E2FE0478BB1AC44E45D930002"><enum>(A)</enum><text display-inline="yes-display-inline">the type, nature, and magnitude of the
financial interests of the advisory committee member to which such
determination or certification applies; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9613DB814E9F4D46AE6B329969708220"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H39B69CFFE591494C9F0CEBDBC3E33775"><enum>(2)</enum><header display-inline="yes-display-inline">Less than 30 days in advance</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HCF539FD5FF71448195CFA102F154AECA"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (d), by striking
<quote>subsection (c)(3)</quote> and inserting <quote>subsection
(c)</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBFFC24E8D6D847449D593F1F0AC06243"><enum>(3)</enum><text display-inline="yes-display-inline">by amending subsection (e) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="H2F9BABBB42E04CB781A93471C998A9B3" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HF178635C4440448FBAFCD08E2D05187F"><enum>(e)</enum><header display-inline="yes-display-inline">Annual report</header>
<paragraph commented="no" display-inline="no-display-inline" id="H6A8212F453224BCE8F8FE37BCE5D4A97"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H6FBBC16AF1F54B939697BE7C89EBA5BA"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H40FD0B07169F435995F1B5C1E419FEB7"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H106A44041B7B4BC783158E7741887FBF"><enum>(C)</enum><text display-inline="yes-display-inline">with respect to such year, the number of
members attending meetings for each advisory committee; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD07297123BBC405EB2A2AC7D09313B67"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H59883714D5944AECA8E35A10D9E155AE"><enum>(2)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H34E0F06F52234BA192F672CA3142C731"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (f), by striking <quote>shall
review guidance</quote> and all that follows through the end of the subsection
and inserting the
following:</text>
<quoted-block display-inline="yes-display-inline" id="H10A01683B990497B9EDA164EF42474ED" style="OLC">
<text>shall—</text><paragraph commented="no" display-inline="no-display-inline" id="HC5DA6EA5E82E4CDC851A8112F21726B9"><enum>(1)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H34705C6EC99845DB9DC6E7B0E998674E"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H862CB7344CCA44EAAEDB893507D84B16"><enum>(5)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H0B6DE2A9040C4513A8539C700BF78C59" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="HE40DA640175D4F2AB158A4B008C42B1A"><enum>(g)</enum><header display-inline="yes-display-inline">Guidance on reported disclosed financial
interest or involvement</header><text display-inline="yes-display-inline">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.</text>
</subsection><after-quoted-block>.
</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HD4BD0455FF7041629B079072501F3EB0"><enum>(b)</enum><header display-inline="yes-display-inline">Applicability</header><text display-inline="yes-display-inline">The amendments made by subsection (a) apply
beginning on October 1, 2012.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H590A8CFE283A4ED98F9FD69C9ED465F8" section-type="subsequent-section"><enum>1143.</enum><header display-inline="yes-display-inline">Notification of FDA intent to regulate
laboratory-developed tests</header>
<subsection commented="no" display-inline="no-display-inline" id="H5EC5C02F981843278D2A68906122CB87"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H54B38CDC67BC4901A3F381BA29953703"><enum>(1)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBD33A54CB5634FAE9912740CAEDF690D"><enum>(2)</enum><text display-inline="yes-display-inline">including in such notification the
anticipated details of such action.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HFCD63A900D8944FDA46F5814F4892EC9"><enum>(b)</enum><header display-inline="yes-display-inline">Sunset</header><text display-inline="yes-display-inline">Subsection (a) shall cease to have force or
effect on the date that is 5 years after the date of enactment of this
Act.</text>
</subsection></section></subtitle><subtitle commented="no" id="H93D0F2B56964449E8C2D4A601BDB5000" level-type="subsequent"><enum>D</enum><header display-inline="yes-display-inline">Synthetic drugs</header>
<section commented="no" display-inline="no-display-inline" id="HC89DD625E8D64D90B24D6854A4092E8B" section-type="subsequent-section"><enum>1151.</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="no-display-inline">This subtitle may be cited as the
<quote><short-title>Synthetic Drug Abuse Prevention Act of
2012 </short-title></quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="H6CB87EA89E8C4B09BC33078653168D90" section-type="subsequent-section"><enum>1152.</enum><header display-inline="yes-display-inline">Addition of synthetic drugs to schedule I
of the Controlled Substances Act</header>
<subsection commented="no" display-inline="no-display-inline" id="HA5585195E3214A96833CDC3AE5A95DF8"><enum>(a)</enum><header display-inline="yes-display-inline">Cannabimimetic agents</header><text display-inline="yes-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="H0C081E3F0EFE49CEAF9C41B8FC80D994" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="H861299A18D084AD88B794BE8C6841178"><enum>(d)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H6122E2C4FD23446F8E3198DE0265C841"><enum>(1)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBCD9C9FF36DF4CF9A3CB2FBC0ABA7DCA" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">In paragraph (1):</text>
<subparagraph commented="no" display-inline="no-display-inline" id="H082B64AB6BDC444882CFF32B1A8B2AF7"><enum>(A)</enum><text display-inline="yes-display-inline">The term <quote>cannabimimetic
agents</quote> 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:</text>
<clause commented="no" display-inline="no-display-inline" id="HBE91D77C9A20401691D1AEFD1EC6525A"><enum>(i)</enum><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HB4A6E7683EA5448DAA27F944FFF71592"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HD1C0A23123FF4D93BB20D0D413C83AE4"><enum>(iii)</enum><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HF38FF4395F1D4CD1B1F816F22A2C7FB1"><enum>(iv)</enum><text display-inline="yes-display-inline">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.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H0FA36BDCCCD84835ABA6B0769DB3BA4D"><enum>(v)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF04F53704E0D4D0883F58A79BBA115A0"><enum>(B)</enum><text display-inline="yes-display-inline">Such term includes—</text>
<clause commented="no" display-inline="no-display-inline" id="HF1C87EE83FC14CA3A384EC86DCB0E215"><enum>(i)</enum><text display-inline="yes-display-inline">5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
(CP–47,497);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HB5471CF7119C40989E05B47235CE4410"><enum>(ii)</enum><text display-inline="yes-display-inline">5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
(cannabicyclohexanol or CP–47,497 C8-homolog);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H057C0130FEED47FF86B0BF94D5DAC128"><enum>(iii)</enum><text display-inline="yes-display-inline">1-pentyl-3-(1-naphthoyl)indole (JWH–018 and
AM678);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H4090F6149254471A9FF8806024300227"><enum>(iv)</enum><text display-inline="yes-display-inline">1-butyl-3-(1-naphthoyl)indole
(JWH–073);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H29009F049581463586E7C093348192DB"><enum>(v)</enum><text display-inline="yes-display-inline">1-hexyl-3-(1-naphthoyl)indole
(JWH–019);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H911DD8A02FBA403BAFA3ABDE75DD07AE"><enum>(vi)</enum><text display-inline="yes-display-inline">1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole
(JWH–200);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H80F086CB3D3144E7977BBBA7F1C89750"><enum>(vii)</enum><text display-inline="yes-display-inline">1-pentyl-3-(2-methoxyphenylacetyl)indole
(JWH–250);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H770FDAD3411A474D8E85C134818CD740"><enum>(viii)</enum><text display-inline="yes-display-inline">1-pentyl-3-[1-(4-methoxynaphthoyl)]indole
(JWH–081);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HD41A23C8913A44A9B3C56555E03D199B"><enum>(ix)</enum><text display-inline="yes-display-inline">1-pentyl-3-(4-methyl-1-naphthoyl)indole
(JWH–122);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H8D365B8A5AF14666BD3B06B6AA642896"><enum>(x)</enum><text display-inline="yes-display-inline">1-pentyl-3-(4-chloro-1-naphthoyl)indole
(JWH–398);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H3F5ADDBB81EC451B923A916F8240AF4C"><enum>(xi)</enum><text display-inline="yes-display-inline">1-(5-fluoropentyl)-3-(1-naphthoyl)indole
(AM2201);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HE0FEF6CA30C549BFBBCB057411A144AB"><enum>(xii)</enum><text display-inline="yes-display-inline">1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole
(AM694);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HF30FD099D3EB431AAB72FC8089223ADC"><enum>(xiii)</enum><text display-inline="yes-display-inline">1-pentyl-3-[(4-methoxy)-benzoyl]indole
(SR–19 and RCS–4);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HA17F2CACD7954A3BA845359C2D2BC824"><enum>(xiv)</enum><text display-inline="yes-display-inline">1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole
(SR–18 and RCS–8); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HB002E865EF634A019241E216138FA016"><enum>(xv)</enum><text display-inline="yes-display-inline">1-pentyl-3-(2-chlorophenylacetyl)indole
(JWH–203).</text>
</clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H451A5FE092B2472A93ADE446B7B7A005"><enum>(b)</enum><header display-inline="yes-display-inline">Other drugs</header><text display-inline="yes-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="H0046F5EB2F134F7FA6C416CF7EF034CA" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="H17E4F3B5D18446CA9E7E61E3EA058D85"><enum>(18)</enum><text display-inline="yes-display-inline">4-methylmethcathinone (Mephedrone).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF2D8AE5EE4F343B89F1C5D9E4FFF2114"><enum>(19)</enum><text display-inline="yes-display-inline">3,4-methylenedioxypyrovalerone
(MDPV).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBEC6D6A1C0EE421FB6B9D989E78AA4DA"><enum>(20)</enum><text display-inline="yes-display-inline">2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine
(2C–E).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H007511B3BC214A13ABF5E82618F4961F"><enum>(21)</enum><text display-inline="yes-display-inline">2-(2,5-Dimethoxy-4-methylphenyl)ethanamine
(2C–D).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H86B4B4D9AD3E46C5B3FF6FD2F66F273C"><enum>(22)</enum><text display-inline="yes-display-inline">2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine
(2C–C).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE92EBEDF52074E92A11CDD204EB09A8A"><enum>(23)</enum><text display-inline="yes-display-inline">2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine
(2C–I).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF17D81A93C7F4963BD5A57DC2831A49C"><enum>(24)</enum><text display-inline="yes-display-inline">2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine
(2C–T–2).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H29CE81CC7C6C40979DC1B396A59375B6"><enum>(25)</enum><text display-inline="yes-display-inline">2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine
(2C–T–4).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB07549FA99F146109D1EECEC3F03F129"><enum>(26)</enum><text display-inline="yes-display-inline">2-(2,5-Dimethoxyphenyl)ethanamine
(2C–H).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF1717EC47ED448A8949E2286A760390F"><enum>(27)</enum><text display-inline="yes-display-inline">2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine
(2C–N).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H175B06153A1C4101965F98AC6EBC7B6C"><enum>(28)</enum><text display-inline="yes-display-inline">2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine
(2C–P).</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H0D4D51F0E3C24368AD8FE4E681A832BA" section-type="subsequent-section"><enum>1153.</enum><header display-inline="yes-display-inline">Temporary scheduling to avoid imminent
hazards to public safety expansion</header><text display-inline="no-display-inline">Section 201(h)(2) of the Controlled
Substances Act (21 U.S.C. 811(h)(2)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="HA702BBD4B4634DB0AF960FEDD5616667"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>one year</quote> and
inserting <quote>2 years</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFDE632E5973244FDAAF1CA181E6960D4"><enum>(2)</enum><text display-inline="yes-display-inline">by striking <quote>six months</quote> and
inserting <quote>1 year</quote>.</text>
</paragraph></section></subtitle>
Speaker of the House of Representatives
Vice President of the United States and President of the
Senate