[House Report 115-201]
[From the U.S. Government Publishing Office]
115th Congress } { Report
HOUSE OF REPRESENTATIVES
1st Session } { 115-201
======================================================================
FDA REAUTHORIZATION ACT OF 2017
_______
July 11, 2017.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Walden, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 2430]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 2430) to amend the Federal Food, Drug, and
Cosmetic Act to revise and extend the user-fee programs for
prescription drugs, medical devices, generic drugs, and
biosimilar biological products, and for other purposes, having
considered the same, report favorably thereon with an amendment
and recommend that the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 36
Background and Need for Legislation.............................. 37
Hearings......................................................... 37
Committee Consideration.......................................... 38
Committee Votes.................................................. 39
Committee Oversight Findings..................................... 41
Statement of General Performance Goals and Objectives............ 41
New Budget Authority, Entitlement Authority, and Tax Expenditures 41
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 41
Committee Cost Estimate.......................................... 41
Congressional Budget Office Estimate............................. 41
Federal Mandates Statement....................................... 41
Duplication of Federal Programs.................................. 41
Disclosure of Directed Rule Makings.............................. 41
Advisory Committee Statement..................................... 42
Applicability to Legislative Branch.............................. 42
Section-by-Section Analysis of the Legislation................... 42
Changes in Existing Law Made by the Bill, as Reported............ 50
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``FDA Reauthorization Act of 2017''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--FEES RELATING TO DRUGS
Sec. 101. Short title; finding.
Sec. 102. Authority to assess and use drug fees.
Sec. 103. Reauthorization; reporting requirements.
Sec. 104. Sunset dates.
Sec. 105. Effective date.
Sec. 106. 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. Conformity assessment pilot program.
Sec. 206. Reauthorization of review.
Sec. 207. Electronic format for submissions.
Sec. 208. Savings clause.
Sec. 209. Effective date.
Sec. 210. Sunset clause.
TITLE III--FEES RELATING TO GENERIC DRUGS
Sec. 301. Short title; finding.
Sec. 302. Definitions.
Sec. 303. Authority to assess and use human generic drug fees.
Sec. 304. Reauthorization; reporting requirements.
Sec. 305. Sunset dates.
Sec. 306. Effective date.
Sec. 307. Savings clause.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Sec. 401. Short title; finding.
Sec. 402. Definitions.
Sec. 403. Authority to assess and use biosimilar fees.
Sec. 404. Reauthorization; reporting requirements.
Sec. 405. Sunset dates.
Sec. 406. Effective date.
Sec. 407. Savings clause.
TITLE V--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS
Sec. 501. Reauthorization of provision relating to exclusivity of
certain drugs containing single enantiomers.
Sec. 502. Reauthorization of orphan grants program.
Sec. 503. Reauthorization of pediatric study of drugs.
Sec. 504. Protecting and strengthening the drug supply chain.
Sec. 505. Sense of Congress on lowering the cost of prescription drugs.
TITLE VI--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS
Subtitle A--Improving the Process for Inspections of Device
Establishments
Sec. 601. Risk-based inspections for devices.
Sec. 602. Recognition of foreign government inspections.
Sec. 603. Improvements to inspections process for device
establishments.
Sec. 604. Certificates to foreign governments for devices.
Sec. 605. Facilitating international harmonization.
Sec. 606. Reauthorization of inspection program.
Subtitle B--Other Provisions
Sec. 611. Reauthorization of pediatric humanitarian device exceptions.
Sec. 612. Reauthorization of pediatric device consortia.
Sec. 613. Regulation of over-the-counter hearing aids.
Sec. 614. Report on ensuring quality, safety, and continued
effectiveness of devices that have been serviced.
Sec. 615. Device pilot projects to generate reliable and timely safety
and active surveillance data.
Sec. 616. Risk-based classification of accessories.
TITLE VII--GENERIC DRUG ACCESS AND COMPETITION
Sec. 701. Competitive Generic Therapies.
Sec. 702. Enhancing regulatory transparency To enhance generic
competition.
Sec. 703. Incentivizing competitive generic therapy development.
Sec. 704. Tropical disease product application.
Sec. 705. GAO study of issues regarding first cycle approvals of
generic medicines.
TITLE VIII--FOSTERING INNOVATION IN MEDICAL IMAGING
Sec. 801. Approval of applications for certain diagnostic medical
imaging devices.
Sec. 802. Applications for approval of contrast agents intended for use
with certain diagnostic medical imaging devices.
TITLE IX--ADDITIONAL PROVISIONS
Sec. 901. Technical corrections.
Sec. 902. Reauthorization of the critical path public-private
partnerships.
TITLE I--FEES RELATING TO DRUGS
SEC. 101. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Prescription Drug
User Fee Amendments of 2017''.
(b) Finding.--The Congress finds that the fees authorized by the
amendments made in this title will be dedicated toward expediting the
drug development process and the process for the review of human drug
applications, including postmarket drug safety activities, as set forth
in the goals identified for purposes of part 2 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters
from the Secretary of Health and Human Services to the Chairman of the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Chairman of the Committee on Energy and Commerce of the House of
Representatives, as set forth in the Congressional Record.
SEC. 102. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--
(1) In general.--Section 736(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(a)) is amended--
(A) in the matter preceding paragraph (1), by
striking ``fiscal year 2013'' and inserting ``fiscal
year 2018'';
(B) in the heading of paragraph (1), by striking
``and supplement'';
(C) in paragraph (1), by striking ``or a supplement''
and ``or supplement'' each place either appears;
(D) in paragraph (1)(A)--
(i) in clause (i), by striking ``(c)(4)'' and
inserting ``(c)(5)''; and
(ii) in clause (ii), by striking ``A fee
established'' and all that follows through
``are required.'' and inserting the following:
``A fee established under subsection (c)(5) for
a human drug application for which clinical
data (other than bioavailability or
bioequivalence studies) with respect to safety
or effectiveness are not required for
approval.'';
(E) in the heading of paragraph (1)(C), by striking
``or supplement'';
(F) in paragraph (1)(F)--
(i) in the heading, by striking ``or
indication''; and
(ii) by striking the second sentence;
(G) by striking paragraph (2) (relating to a
prescription drug establishment fee);
(H) by redesignating paragraph (3) as paragraph (2);
(I) in the heading of paragraph (2), as so
redesignated, by striking ``Prescription drug product
fee'' and inserting ``Prescription drug program fee'';
(J) in subparagraph (A) of such paragraph (2), by
amending the first sentence to read as follows:
``Except as provided in subparagraphs (B) and (C), each
person who is named as the applicant in a human drug
application, and who, after September 1, 1992, had
pending before the Secretary a human drug application
or supplement, shall pay the annual prescription drug
program fee established for a fiscal year under
subsection (c)(5) for each prescription drug product
that is identified in such a human drug application
approved as of October 1 of such fiscal year.'';
(K) in subparagraph (B) of such paragraph (2)--
(i) in the heading of subparagraph (B), by
inserting after ``Exception'' the following:
``for certain prescription drug products''; and
(ii) by striking ``A prescription drug
product shall not be assessed a fee'' and
inserting ``A prescription drug program fee
shall not be assessed for a prescription drug
product''; and
(L) by adding at the end of such paragraph (2) the
following:
``(C) Limitation.--A person who is named as the
applicant in an approved human drug application shall
not be assessed more than 5 prescription drug program
fees for a fiscal year for prescription drug products
identified in such approved human drug application.''.
(2) Conforming amendment.--Subparagraph (C) of section
740(a)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-12(a)(3)) is amended to read as follows:
``(C) Limitation.--An establishment shall be assessed
only one fee per fiscal year under this section.''.
(b) Fee Revenue Amounts.--Subsection (b) of section 736 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended to
read as follows:
``(b) Fee Revenue Amounts.--
``(1) In general.--For each of the fiscal years 2018 through
2022, fees under subsection (a) shall, except as provided in
subsections (c), (d), (f), and (g), be established to generate
a total revenue amount under such subsection that is equal to
the sum of--
``(A) the annual base revenue for the fiscal year (as
determined under paragraph (3));
``(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined under
subsection (c)(1));
``(C) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as determined
under subsection (c)(2));
``(D) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if applicable
(as determined under subsection (c)(3));
``(E) the dollar amount equal to the additional
direct cost adjustment for the fiscal year (as
determined under subsection (c)(4)); and
``(F) additional dollar amounts for each fiscal year
as follows:
``(i) $20,077,793 for fiscal year 2018.
``(ii) $21,317,472 for fiscal year 2019.
``(iii) $16,953,329 for fiscal year 2020.
``(iv) $5,426,896 for fiscal year 2021.
``(v) $2,769,609 for fiscal year 2022.
``(2) Types of fees.--Of the total revenue amount determined
for a fiscal year under paragraph (1)--
``(A) 20 percent shall be derived from human drug
application fees under subsection (a)(1); and
``(B) 80 percent shall be derived from prescription
drug program fees under subsection (a)(2).
``(3) Annual base revenue.--For purposes of paragraph (1),
the dollar amount of the annual base revenue for a fiscal year
shall be--
``(A) for fiscal year 2018, $878,590,000; and
``(B) for fiscal years 2019 through 2022, the dollar
amount of the total revenue amount established under
paragraph (1) for the previous fiscal year, not
including any adjustments made under subsection (c)(3)
or (c)(4).''.
(c) Adjustments; Annual Fee Setting.--Subsection (c) of section 736
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended
to read as follows:
``(c) Adjustments; Annual Fee Setting.--
``(1) Inflation adjustment.--
``(A) In general.--For purposes of subsection
(b)(1)(B), the dollar amount of the inflation
adjustment to the annual base revenue for each fiscal
year shall be equal to the product of--
``(i) such annual base revenue for the fiscal
year under subsection (b)(1)(A); and
``(ii) the inflation adjustment percentage
under subparagraph (B).
``(B) Inflation adjustment percentage.--The inflation
adjustment percentage under this subparagraph for a
fiscal year is equal to the sum of--
``(i) the average annual percent change in
the cost, per full-time equivalent position of
the Food and Drug Administration, of all
personnel compensation and benefits paid with
respect to such positions for the first 3 years
of the preceding 4 fiscal years, multiplied by
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
``(ii) the average annual percent change that
occurred in the Consumer Price Index for urban
consumers (Washington-Baltimore, DC-MD-VA-WV;
Not Seasonally Adjusted; All items; Annual
Index) for the first 3 years of the preceding 4
years of available data multiplied by 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.
``(2) Capacity planning adjustment.--
``(A) In general.--For each fiscal year, after the
annual base revenue established in subsection (b)(1)(A)
is adjusted for inflation in accordance with paragraph
(1), such revenue shall be adjusted further for such
fiscal year, in accordance with this paragraph, to
reflect changes in the resource capacity needs of the
Secretary for the process for the review of human drug
applications.
``(B) Interim methodology.--
``(i) In general.--Until the capacity
planning methodology described in subparagraph
(C) is effective, the adjustment under this
paragraph for a fiscal year shall be based on
the product of--
``(I) the annual base revenue for
such year, as adjusted for inflation
under paragraph (1); and
``(II) the adjustment percentage
under clause (ii).
``(ii) Adjustment percentage.--The adjustment
percentage under this clause for a fiscal year
is the weighted change in the 3-year average
ending in the most recent year for which data
are available, over the 3-year average ending
in the previous year, for--
``(I) the total number of human drug
applications, efficacy supplements, and
manufacturing supplements submitted to
the Secretary;
``(II) the total number of active
commercial investigational new drug
applications; and
``(III) the total number of formal
meetings scheduled by the Secretary,
and written responses issued by the
Secretary in lieu of such formal
meetings, as identified in section I.H
of the letters described in section
101(b) of the Prescription Drug User
Fee Amendments of 2017.
``(C) Capacity planning methodology.--
``(i) Development; evaluation and report.--
The Secretary shall obtain, through a contract
with an independent accounting or consulting
firm, a report evaluating options and
recommendations for a new methodology to
accurately assess changes in the resource and
capacity needs of the process for the review of
human drug applications. The capacity planning
methodological options and recommendations
presented in such report shall utilize and be
informed by personnel time reporting data as an
input. The report shall be published for public
comment no later than the end of fiscal year
2020.
``(ii) Establishment and implementation.--
After review of the report described in clause
(i) and any public comments thereon, the
Secretary shall establish a capacity planning
methodology for purposes of this paragraph,
which shall--
``(I) replace the interim methodology
under subparagraph (B);
``(II) incorporate such approaches
and attributes as the Secretary
determines appropriate; and
``(III) be effective beginning with
the first fiscal year for which fees
are set after such capacity planning
methodology is established.
``(D) Limitation.--Under no circumstances shall an
adjustment under this paragraph result in fee revenue
for a fiscal year that is less than the sum of the
amounts under subsections (b)(1)(A) (the annual base
revenue for the fiscal year) and (b)(1)(B) (the dollar
amount of the inflation adjustment for the fiscal
year).
``(E) Publication in federal register.--The Secretary
shall publish in the Federal Register notice under
paragraph (5) the fee revenue and fees resulting from
the adjustment and the methodologies under this
paragraph.
``(3) Operating reserve adjustment.--
``(A) Increase.--For fiscal year 2018 and subsequent
fiscal years, the Secretary may, in addition to
adjustments under paragraphs (1) and (2), further
increase the fee revenue and fees if such an adjustment
is necessary to provide for not more than 14 weeks of
operating reserves of carryover user fees for the
process for the review of human drug applications.
``(B) Decrease.--If the Secretary has carryover
balances for such process in excess of 14 weeks of such
operating reserves, the Secretary shall decrease such
fee revenue and fees to provide for not more than 14
weeks of such operating reserves.
``(C) Notice of rationale.--If an adjustment under
subparagraph (A) or (B) is made, the rationale for the
amount of the increase or decrease (as applicable) in
fee revenue and fees shall be contained in the annual
Federal Register notice under paragraph (5)
establishing fee revenue and fees for the fiscal year
involved.
``(4) Additional direct cost adjustment.--
``(A) In general.--The Secretary shall, in addition
to adjustments under paragraphs (1), (2), and (3),
further increase the fee revenue and fees--
``(i) for fiscal year 2018, by $8,730,000;
and
``(ii) for fiscal year 2019 and subsequent
fiscal years, by the amount determined under
subparagraph (B).
``(B) Amount.--The amount determined under this
subparagraph is--
``(i) $8,730,000, multiplied by
``(ii) the Consumer Price Index for urban
consumers (Washington-Baltimore, DC-MD-VA-WV;
Not Seasonally Adjusted; All Items; Annual
Index) for the most recent year of available
data, divided by such Index for 2016.
``(5) Annual fee setting.--The Secretary shall, not later
than 60 days before the start of each fiscal year that begins
after September 30, 2017--
``(A) establish, for the next fiscal year, human drug
application fees and prescription drug program fees
under subsection (a), based on the revenue amounts
established under subsection (b) and the adjustments
provided under this subsection; and
``(B) publish such fee revenue and fees in the
Federal Register.
``(6) Limit.--The total amount of fees charged, as adjusted
under this subsection, for a fiscal year may not exceed the
total costs for such fiscal year for the resources allocated
for the process for the review of human drug applications.''.
(d) Fee Waiver or Reduction.--Section 736(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--
(1) in paragraph (1)--
(A) by inserting ``or'' at the end of subparagraph
(B);
(B) by striking subparagraph (C); and
(C) by redesignating subparagraph (D) as subparagraph
(C);
(2) by striking paragraph (3) (relating to use of standard
costs);
(3) by redesignating paragraph (4) as paragraph (3); and
(4) in paragraph (3), as so redesignated--
(A) in subparagraphs (A) and (B), by striking
``paragraph (1)(D)'' and inserting ``paragraph
(1)(C)''; and
(B) in subparagraph (B)--
(i) by striking clause (ii);
(ii) by striking ``shall pay'' through ``(i)
application fees'' and inserting ``shall pay
application fees''; and
(iii) by striking ``; and'' at the end and
inserting a period.
(e) Effect of Failure To Pay Fees.--Section 736(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is amended by striking
``all fees'' and inserting ``all such fees''.
(f) Limitations.--Section 736(f)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by striking
``supplements, prescription drug establishments, and prescription drug
products'' and inserting ``prescription drug program fees''.
(g) Crediting and Availability of Fees.--Section 736(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)) is amended--
(1) in paragraph (3)--
(A) by striking ``2013 through 2017'' and inserting
``2018 through 2022''; and
(B) by striking ``and paragraph (4) of this
subsection''; and
(2) by striking paragraph (4).
(h) Orphan Drugs.--Section 736(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking ``product and
establishment fees'' each place it appears and inserting ``prescription
drug program fees''.
SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h-2) is amended--
(1) in subsection (a)(1)--
(A) in the matter before subparagraph (A), by
striking ``2013'' and inserting ``2018''; and
(B) in subparagraph (A), by striking ``Prescription
Drug User Fee Amendments of 2012'' and inserting
``Prescription Drug User Fee Amendments of 2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018''; and
(3) in subsection (d), by striking ``2017'' each place it
appears and inserting ``2022''.
SEC. 104. SUNSET DATES.
(a) Authorization.--Sections 735 and 736 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective
October 1, 2022.
(b) Reporting Requirements.--Section 736B of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h-2) shall cease to be effective January
31, 2023.
(c) Previous Sunset Provision.--Effective October 1, 2017,
subsections (a) and (b) of section 105 of the Food and Drug
Administration Safety and Innovation Act (Public Law 112-144) are
repealed.
SEC. 105. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, 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, 2017, regardless of
the date of the enactment of this Act.
SEC. 106. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 2 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act, as in effect on the day before the date of the enactment of this
title, shall continue to be in effect with respect to human drug
applications and supplements (as defined in such part as of such day)
that on or after October 1, 2012, but before October 1, 2017, 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 2018.
TITLE II--FEES RELATING TO DEVICES
SEC. 201. SHORT TITLE; FINDINGS.
(a) Short Title.--This title may be cited as the ``Medical Device
User Fee Amendments of 2017''.
(b) Findings.--The Congress finds that the fees authorized under the
amendments made by this title will be dedicated toward expediting the
process for the review of device applications and for assuring the
safety and effectiveness of devices, as set forth in the goals
identified for purposes of part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act in the letters from the Secretary
of Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the Chairman
of the Committee on Energy and Commerce of the House of
Representatives, as set forth in the Congressional Record.
SEC. 202. DEFINITIONS.
Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379i) is amended--
(1) by redesignating paragraphs (8) through (13) as
paragraphs (9) through (14), respectively;
(2) by inserting after paragraph (7) the following new
paragraph:
``(8) The term `de novo classification request' means a
request made under section 513(f)(2)(A) with respect to the
classification of a device.'';
(3) in subparagraph (D) of paragraph (10) (as redesignated by
paragraph (1)), by striking ``and submissions'' and inserting
``submissions, and de novo classification requests''; and
(4) in paragraph (11) (as redesignated by paragraph (1)), by
striking ``2011'' and inserting ``2016''.
SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.
(a) Types of Fees.--Section 738(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(a)) is amended--
(1) in paragraph (1), by striking ``fiscal year 2013'' and
inserting ``fiscal year 2018''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
striking ``October 1, 2012'' and inserting
``October 1, 2017'';
(ii) in clause (viii), by striking ``2'' and
inserting ``3.4''; and
(iii) by adding at the end the following new
clause:
``(xi) For a de novo classification request,
a fee equal to 30 percent of the fee that
applies under clause (i).''; and
(B) in subparagraph (B)(v)(I), by striking ``or
premarket notification submission'' and inserting
``premarket notification submission, or de novo
classification request''.
(b) Fee Amounts.--Section 738(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(b)) is amended to read as follows:
``(b) Fee Amounts.--
``(1) In general.--Subject to subsections (c), (d), (e), and
(h), for each of fiscal years 2018 through 2022, fees under
subsection (a) shall be derived from the base fee amounts
specified in paragraph (2), to generate the total revenue
amounts specified in paragraph (3).
``(2) Base fee amounts specified.--For purposes of paragraph
(1), the base fee amounts specified in this paragraph are as
follows:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
``Fee Type Year 2018 Year 2019 Year 2020 Year 2021 Year 2022
----------------------------------------------------------------------------------------------------------------
Premarket Application.................................... $294,000 $300,000 $310,000 $328,000 $329,000
Establishment Registration............................... $4,375 $4,548 $4,760 $4,975 $4,978
----------------------------------------------------------------------------------------------------------------
``(3) Total revenue amounts specified.--For purposes of
paragraph (1), the total revenue amounts specified in this
paragraph are as follows:
``(A) $183,280,756 for fiscal year 2018.
``(B) $190,654,875 for fiscal year 2019.
``(C) $200,132,014 for fiscal year 2020.
``(D) $211,748,789 for fiscal year 2021.
``(E) $213,687,660 for fiscal year 2022.''.
(c) Annual Fee Setting; Adjustments.--Section 738(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended--
(1) in paragraph (1), by striking ``2012'' and inserting
``2017'';
(2) in paragraph (2)--
(A) in subparagraph (A), by striking ``2014'' and
inserting ``2018'';
(B) by striking subparagraph (B) and inserting the
following new subparagraph:
``(B) Applicable inflation adjustment.--The
applicable inflation adjustment for fiscal year 2018
and each subsequent fiscal year is the product of--
``(i) the base inflation adjustment under
subparagraph (C) for such fiscal year; and
``(ii) the product of the base inflation
adjustment under subparagraph (C) for each of
the fiscal years preceding such fiscal year,
beginning with fiscal year 2016.'';
(C) in subparagraph (C), in the heading, by striking
``to total revenue amounts''; and
(D) by amending subparagraph (D) to read as follows:
``(D) Adjustment to base fee amounts.--For each of
fiscal years 2018 through 2022, the Secretary shall--
``(i) adjust the base fee amounts specified
in subsection (b)(2) for such fiscal year by
multiplying such amounts by the applicable
inflation adjustment under subparagraph (B) for
such year; and
``(ii) if the Secretary determines necessary,
increase (in addition to the adjustment under
clause (i)) such base fee amounts, on a uniform
proportionate basis, to generate the total
revenue amounts under subsection (b)(3), as
adjusted for inflation under subparagraph
(A).''; and
(3) in paragraph (3)--
(A) by striking ``2014 through 2017'' and inserting
``2018 through 2022''; and
(B) by striking ``further adjusted'' and inserting
``increased''.
(d) Small Businesses; Fee Waiver and Fee Reduction Regarding
Premarket Approval Fees.--Section 738(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(d)) is amended--
(1) in paragraph (1), by striking ``specified in clauses (i)
through (v) and clauses (vii), (ix), and (x)'' and inserting
``specified in clauses (i) through (vii) and clauses (ix), (x),
and (xi)''; and
(2) in paragraph (2)(C)--
(A) by striking ``supplement, or'' and inserting
``supplement,''; and
(B) by inserting ``, or a de novo classification
request'' after ``class III device''.
(e) Small Businesses; Fee Reduction Regarding Premarket Notification
Submissions.--Section 738(e)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended by striking ``50''
and inserting ``25''.
(f) Fee Waiver or Reduction.--
(1) Repeal.--Section 738 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j) is amended by striking subsection
(f).
(2) Conforming changes.--
(A) Section 515(c)(4)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended
by striking ``738(h)'' and inserting ``738(g)''.
(B) Section 738 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j), as amended by paragraph
(1), is further amended--
(i) by redesignating subsections (g) through
(l) as subsections (f) through (k);
(ii) in subsection (a)(2)(A), by striking
``(d), (e), and (f)'' and inserting ``(d) and
(e)''; and
(iii) in subsection (a)(3)(A), by striking
``and subsection (f)''.
(g) Effect of Failure To Pay Fees.--Subsection (f)(1), as
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j) is amended--
(1) by striking ``or periodic reporting concerning a class
III device'' and inserting ``periodic reporting concerning a
class III device, or de novo classification request''; and
(2) by striking ``all fees'' and inserting ``all such fees''.
(h) Conditions.--Subsection (g)(1)(A), as redesignated, of section
738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is
amended by striking ``$280,587,000'' and inserting ``$320,825,000''.
(i) Crediting and Availability of Fees.--Subsection (h), as
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j) is amended--
(1) in paragraph (3)--
(A) by striking ``2013 through 2017'' and inserting
``2018 through 2022''; and
(B) by striking ``subsection (c)'' and all that
follows through the period at the end and inserting
``subsection (c).''; and
(2) by striking paragraph (4).
SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Reports.--Section 738A(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-1(a)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) by striking ``2013'' and inserting
``2018''; and
(ii) by striking ``the Medical Device User
Fee Amendments of 2012'' and inserting ``the
Medical Device User Fee Amendments of 2017'';
and
(B) in subparagraph (B), by striking ``the Medical
Device User Fee Amendments Act of 2012'' and inserting
``the Medical Device User Fee Amendments of 2017''; and
(2) in paragraph (2), by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
(b) Reauthorization.--Section 738A(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
(1) in paragraph (1), by striking ``2017'' and inserting
``2022''; and
(2) in paragraph (5), by striking ``2017'' and inserting
``2022''.
SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.
(a) In General.--Section 514 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360d) is amended by adding at the end the following:
``(d) Pilot Accreditation Scheme for Conformity Assessment.--
``(1) In general.--The Secretary shall establish a pilot
program under which--
``(A) testing laboratories may be accredited, by
accreditation bodies meeting criteria specified by the
Secretary, to assess the conformance of a device with
certain standards recognized under this section; and
``(B) subject to paragraph (2), determinations by
testing laboratories so accredited that a device
conforms with such standard or standards shall be
accepted by the Secretary for purposes of demonstrating
such conformity under this section unless the Secretary
finds that a particular such determination shall not be
so accepted.
``(2) Secretarial review of accredited laboratory
determinations.--The Secretary may--
``(A) review determinations by testing laboratories
accredited pursuant to this subsection, including by
conducting periodic audits of such determinations or
processes of accredited bodies or testing laboratories
and, following such review, taking additional measures
under this Act, such as suspension or withdrawal of
accreditation of such testing laboratory under
paragraph (1)(A) or requesting additional information
with respect to such device, as the Secretary
determines appropriate; and
``(B) if the Secretary becomes aware of information
materially bearing on safety or effectiveness of a
device assessed for conformity by a testing laboratory
so accredited, take such additional measures under this
Act as the Secretary determines appropriate, such as
suspension or withdrawal of accreditation of such
testing laboratory under paragraph (1)(A), or
requesting additional information with regard to such
device.
``(3) Implementation and reporting.--
``(A) Public meeting.--The Secretary shall publish in
the Federal Register a notice of a public meeting to be
held no later than September 30, 2018, to discuss and
obtain input and recommendations from stakeholders
regarding the goals and scope of, and a suitable
framework and procedures and requirements for, the
pilot program under this subsection.
``(B) Pilot program guidance.--The Secretary shall--
``(i) not later than September 30, 2019,
issue draft guidance regarding the goals and
implementation of the pilot program under this
subsection; and
``(ii) not later than September 30, 2021,
issue final guidance with respect to the
implementation of such program.
``(C) Pilot program initiation.--Not later than
September 30, 2020, the Secretary shall initiate the
pilot program under this subsection.
``(D) Report.--The Secretary shall make available on
the website of the Food and Drug Administration an
annual report on the progress of the pilot program
under this subsection.
``(4) Sunset.--As of October 1, 2022--
``(A) the authority for accreditation bodies to
accredit testing laboratories pursuant to paragraph
(1)(A) shall cease to have force or effect;
``(B) the Secretary--
``(i) may not accept a determination pursuant
to paragraph (1)(B) made by a testing
laboratory after such date; and
``(ii) may accept such a determination made
prior to such date;
``(C) except for purposes of accepting a
determination described in subparagraph (B)(ii), the
Secretary shall not continue to recognize the
accreditation of testing laboratories accredited under
paragraph (1)(A); and
``(D) the Secretary may take actions in accordance
with paragraph (2) with respect to the determinations
made prior to such date and recognition of the
accreditation of testing laboratories pursuant to
determinations made prior to such date.''.
SEC. 206. REAUTHORIZATION OF REVIEW.
Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360m) is amended--
(1) in subsection (a)(3)--
(A) in subparagraph (A), by striking clauses (ii) and
(iii) and inserting the following:
``(ii) a device classified under section
513(f)(2) or designated under section 515C(d);
or
``(iii) a device that is of a type, or subset
of a type, listed as not eligible for review
under subparagraph (B)(iii).'';
(B) by striking subparagraph (B) and inserting the
following:
``(B) Designation for review.--The Secretary shall--
``(i) issue draft guidance on the factors the
Secretary will use in determining whether a
class I or class II device type, or subset of
such device types, is eligible for review by an
accredited person, including--
``(I) the risk of the device type, or
subset of such device type; and
``(II) whether the device type, or
subset of such device type, is
permanently implantable, life
sustaining, or life supporting;
``(ii) not later than 24 months after the
date on which the Secretary issues such draft
guidance, finalize such guidance; and
``(iii) beginning on the date such guidance
is finalized, designate and post on the
internet website of the Food and Drug
Administration, an updated list of class I and
class II device types, or subsets of such
device types, and the Secretary's determination
with respect to whether each such device type,
or subset of a device type, is eligible or not
eligible for review by an accredited person
under this section based on the factors
described in clause (i).''; and
(C) by adding at the end the following:
``(C) Interim rule.--Until the date on which the
updated list is designated and posted in accordance
with subparagraph (B)(iii), the list in effect on the
date of enactment the Medical Device User Fee
Amendments of 2017 shall be in effect.'';
(2) in subsection (b)--
(A) in paragraph (2)--
(i) by striking subparagraph (D); and
(ii) by redesignating subparagraph (E) as
subparagraph (D); and
(B) in paragraph (3)--
(i) by redesignating subparagraph (E) as
subparagraph (F);
(ii) in subparagraph (F) (as so
redesignated), by striking ``The operations
of'' and all that follows through ``it will--''
and inserting ``Such person shall agree, at a
minimum, to include in its request for
accreditation a commitment to, at the time of
accreditation, and at any time it is performing
any review pursuant to this section--''; and
(iii) by inserting after subparagraph (D) the
following new subparagraph:
``(E) The operations of such person shall be in
accordance with generally accepted professional and
ethical business practices.''; and
(3) in subsection (c), by striking ``2017'' and inserting
``2022''.
SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS.
Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379k-1(b)) is amended by adding at the end the following new
paragraph:
``(3) Presubmissions and submissions solely in electronic
format.--
``(A) In general.--Beginning on such date as the
Secretary specifies in final guidance issued under
subparagraph (C), presubmissions and submissions for
devices described in paragraph (1) (and any appeals of
action taken by the Secretary with respect to such
presubmissions or submissions) shall be submitted
solely in such electronic format as specified by the
Secretary in such guidance.
``(B) Draft guidance.--The Secretary shall, not later
than October 1, 2019, issue draft guidance providing
for--
``(i) any further standards for the
submission by electronic format required under
subparagraph (A);
``(ii) a timetable for the establishment by
the Secretary of such further standards; and
``(iii) criteria for waivers of and
exemptions from the requirements of this
subsection.
``(C) Final guidance.--The Secretary shall, not later
than 12 months after the close of the public comment
period on the draft guidance issued under subparagraph
(B), issue final guidance described in clauses (i)
through (iii) of such subparagraph.''.
SEC. 208. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 3 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379i et seq.), as in effect on the day before the date of
the enactment of this title, shall continue to be in effect with
respect to the submissions listed in section 738(a)(2)(A) of such Act
(as defined in such part as of such day) that on or after October 1,
2012, but before October 1, 2017, 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 2018.
SEC. 209. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, 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, 2017, regardless of the date of the enactment of this
Act.
SEC. 210. SUNSET CLAUSE.
(a) Authorization.--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, 2022.
(b) Reporting Requirements.--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, 2023.
(c) Previous Sunset Provision.--Effective October 1, 2017, section
207(a) of the Medical Device User Fee Amendments of 2012 (Public Law
112-144) is repealed.
TITLE III--FEES RELATING TO GENERIC DRUGS
SEC. 301. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Generic Drug User
Fee Amendments of 2017''.
(b) Finding.--The Congress finds that the fees authorized by the
amendments made in this title will be dedicated to human generic drug
activities, as set forth in the goals identified for purposes of part 7
of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act, in the letters from the Secretary of Health and Human Services to
the Chairman of the Committee on Health, Education, Labor, and Pensions
of the Senate and the Chairman of the Committee on Energy and Commerce
of the House of Representatives, as set forth in the Congressional
Record.
SEC. 302. DEFINITIONS.
Section 744A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-41) is amended--
(1) in paragraph (1)(B), by striking ``application for a
positron emission tomography drug.'' and inserting
``application--
``(i) for a positron emission tomography
drug; or
``(ii) submitted by a State or Federal
governmental entity for a drug that is not
distributed commercially.'';
(2) by redesignating paragraphs (5) through (12) as
paragraphs (6) through (13), respectively; and
(3) by inserting after paragraph (4) the following:
``(5) The term `contract manufacturing organization facility'
means a manufacturing facility of a finished dosage form of a
drug approved pursuant to an abbreviated new drug application,
where such manufacturing facility is not identified in an
approved abbreviated new drug application held by the owner of
such facility or an affiliate of such owner or facility.''.
SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.
(a) Types of Fees.--Section 744B(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-42(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``fiscal year 2013'' and inserting ``fiscal year 2018'';
(2) in paragraph (1), by adding at the end the following:
``(E) Sunset.--This paragraph shall cease to be
effective October 1, 2022.'';
(3) in paragraph (2)--
(A) by amending subparagraph (C) to read as follows:
``(C) Notice.--Not later than 60 days before the
start of each of fiscal years 2018 through 2022, the
Secretary shall publish in the Federal Register the
amount of the drug master file fee established by this
paragraph for such fiscal year.''; and
(B) in subparagraph (E)--
(i) in clause (i)--
(I) by striking ``no later than the
date'' and inserting ``on the earlier
of--
``(I) the date'';
(II) by striking the period and
inserting ``; or''; and
(III) by adding at the end the
following:
``(II) the date on which the drug
master file holder requests the initial
completeness assessment.''; and
(ii) in clause (ii), by striking ``notice
provided for in clause (i) or (ii) of
subparagraph (C), as applicable'' and inserting
``notice provided for in subparagraph (C)'';
(4) in paragraph (3)--
(A) in the heading, by striking ``and prior approval
supplement'';
(B) in subparagraph (A), by striking ``or a prior
approval supplement to an abbreviated new drug
application'';
(C) by amending subparagraphs (B) and (C) to read as
follows:
``(B) Notice.--Not later than 60 days before the
start of each of fiscal years 2018 through 2022, the
Secretary shall publish in the Federal Register the
amount of the fees under subparagraph (A) for such
fiscal year.
``(C) Fee due date.--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.'';
(D) in subparagraph (D)--
(i) in the heading, by inserting ``, is
withdrawn prior to being received, or is no
longer received'' after ``received''; and
(ii) by striking ``The Secretary shall'' and
all that follows through the period and
inserting the following:
``(i) Applications not considered to have
been received and applications withdrawn prior
to being received.--The Secretary shall refund
75 percent of the fee paid under subparagraph
(A) for any 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, or that has been withdrawn prior to
being received within the meaning of section
505(j)(5)(A).
``(ii) Applications no longer received.--The
Secretary shall refund 100 percent of the fee
paid under subparagraph (A) for any abbreviated
new drug application if the Secretary initially
receives the application under section
505(j)(5)(A) and subsequently determines that
an exclusivity period for a listed drug should
have prevented the Secretary from receiving
such application, such that the abbreviated new
drug application is no longer received within
the meaning of section 505(j)(5)(A).'';
(E) in subparagraph (E), by striking ``or prior
approval supplement''; and
(F) in the matter preceding clause (i) of
subparagraph (F)--
(i) by striking ``2012'' and inserting
``2017''; and
(ii) by striking ``subsection (d)(3)'' and
inserting ``subsection (d)(2)'';
(5) in paragraph (4)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i) and in
clause (iii), by striking ``, or intended to be
identified, in at least one generic drug
submission that is pending or'' and inserting
``in at least one generic drug submission that
is'';
(ii) in clause (i), by striking ``or intended
to be identified in at least one generic drug
submission that is pending or'' and inserting
``in at least one generic drug submission that
is'';
(iii) in clause (ii), by striking
``produces,'' and all that follows through
``such a'' and inserting ``is identified in at
least one generic drug submission in which the
facility is approved to produce one or more
active pharmaceutical ingredients or in a Type
II active pharmaceutical ingredient drug master
file referenced in at least one such''; and
(iv) in clause (iii), by striking ``to fees
under both such clauses'' and inserting ``only
to the fee attributable to the manufacture of
the finished dosage forms''; and
(B) by amending subparagraphs (C) and (D) to read as
follows:
``(C) Notice.--Within the timeframe specified in
subsection (d)(1), the Secretary shall publish in the
Federal Register the amount of the fees under
subparagraph (A) for such fiscal year.
``(D) Fee due date.--For each of fiscal years 2018
through 2022, the fees under subparagraph (A) for such
fiscal year shall be due on the later of--
``(i) the first business day on or after
October 1 of each such year; or
``(ii) the first business day after the
enactment of an appropriations Act providing
for the collection and obligation of fees for
such year under this section for such year.'';
(6) by redesignating paragraph (5) as paragraph (6); and
(7) by inserting after paragraph (4) the following:
``(5) Generic drug applicant program fee.--
``(A) In general.--A generic drug applicant program
fee shall be assessed annually as described in
subsection (b)(2)(E).
``(B) Amount.--The amount of fees established under
subparagraph (A) shall be established under subsection
(d).
``(C) Notice.--Within the timeframe specified in
subsection (d)(1), the Secretary shall publish in the
Federal Register the amount of the fees under
subparagraph (A) for such fiscal year.
``(D) Fee due date.--For each of fiscal years 2018
through 2022, the fees under subparagraph (A) for such
fiscal year shall be due on the later of--
``(i) the first business day on or after
October 1 of each such fiscal year; or
``(ii) the first business day after the date
of enactment of an appropriations Act providing
for the collection and obligation of fees for
such fiscal year under this section for such
fiscal year.''.
(b) Fee Revenue Amounts.--Section 744B(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-42(b)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) in the heading, by striking ``2013'' and
inserting ``2018'';
(ii) by striking ``2013'' and inserting
``2018'';
(iii) by striking ``$299,000,000'' and
inserting ``$493,600,000''; and
(iv) by striking ``Of that amount'' and all
that follows through the end of clause (ii);
and
(B) in subparagraph (B)--
(i) in the heading, by striking ``2014
through 2017'' and inserting ``2019 through
2022'';
(ii) by striking ``2014 through 2017'' and
inserting ``2019 through 2022'';
(iii) by striking ``paragraphs (2) through
(4)'' and inserting ``paragraphs (2) through
(5)''; and
(iv) by striking ``$299,000,000'' and
inserting ``$493,600,000''; and
(2) in paragraph (2)--
(A) in the matter preceding subparagraph (A)--
(i) by striking ``paragraph (1)(A)(ii) for
fiscal year 2013 and paragraph (1)(B) for each
of fiscal years 2014 through 2017'' and
inserting ``such paragraph for a fiscal year'';
and
(ii) by striking ``through (4)'' and
inserting ``through (5)'';
(B) in subparagraph (A), by striking ``Six percent''
and inserting ``Five percent'';
(C) by amending subparagraphs (B) and (C) to read as
follows:
``(B) Thirty-three percent shall be derived from fees
under subsection (a)(3) (relating to abbreviated new
drug applications).
``(C) Twenty percent shall be derived from fees under
subsection (a)(4)(A)(i) (relating to generic drug
facilities). The amount of the fee for a contract
manufacturing organization facility shall be equal to
one-third the amount of the fee for a facility that is
not a contract manufacturing organization facility. The
amount of the fee for a facility located outside the
United States and its territories and possessions shall
be $15,000 higher than the amount of the fee for a
facility located in the United States and its
territories and possessions.'';
(D) in subparagraph (D)--
(i) by striking ``Fourteen percent'' and
inserting ``Seven percent'';
(ii) by striking ``not less than $15,000 and
not more than $30,000'' and inserting
``$15,000''; and
(iii) by striking ``, as determined'' and all
that follows through the period at the end and
inserting a period; and
(E) by adding at the end the following:
``(E)(i) Thirty-five percent shall be derived from
fees under subsection (a)(5) (relating to generic drug
applicant program fees). For purposes of this
subparagraph, if a person has affiliates, a single
program fee shall be assessed with respect to that
person, including its affiliates, and may be paid by
that person or any one of its affiliates. The Secretary
shall determine the fees as follows:
``(I) If a person (including its affiliates)
owns at least one but not more than 5 approved
abbreviated new drug applications on the due
date for the fee under this subsection, the
person (including its affiliates) shall be
assessed a small business generic drug
applicant program fee equal to one-tenth of the
large size operation generic drug applicant
program fee.
``(II) If a person (including its affiliates)
owns at least 6 but not more than 19 approved
abbreviated new drug applications on the due
date for the fee under this subsection, the
person (including its affiliates) shall be
assessed a medium size operation generic drug
applicant program fee equal to two-fifths of
the large size operation generic drug applicant
program fee.
``(III) If a person (including its
affiliates) owns 20 or more approved
abbreviated new drug applications on the due
date for the fee under this subsection, the
person (including its affiliates) shall be
assessed a large size operation generic drug
applicant program fee.
``(ii) For purposes of this subparagraph, an
abbreviated new drug application shall be deemed not to
be approved if the applicant has submitted a written
request for withdrawal of approval of such abbreviated
new drug application by April 1 of the previous fiscal
year.''.
(c) Adjustments.--Section 744B(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-42(c)) is amended--
(1) in paragraph (1)--
(A) by striking ``2014'' and inserting ``2019'';
(B) by inserting ``to equal the product of the total
revenues established in such notice for the prior
fiscal year multiplied'' after ``a fiscal year,''; and
(C) by striking the flush text following subparagraph
(C); and
(2) in paragraph (2)--
(A) by striking ``2017'' each place it appears and
inserting ``2022'';
(B) by striking ``the first 3 months of fiscal year
2018'' and inserting ``the first 3 months of fiscal
year 2023''; and
(C) by striking ``Such fees may only be used in
fiscal year 2018.''.
(d) Annual Fee Setting.--Section 744B(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-42(d)) is amended--
(1) by striking paragraphs (1) and (2) and inserting the
following:
``(1) Fiscal years 2018 through 2022.--Not more than 60 days
before the first day of each of fiscal years 2018 through 2022,
the Secretary shall establish the fees described in paragraphs
(2) through (5) of subsection (a), based on the revenue amounts
established under subsection (b) and the adjustments provided
under subsection (c).'';
(2) by redesignating paragraph (3) as paragraph (2); and
(3) in paragraph (2) (as so redesignated), in the matter
preceding subparagraph (A), by striking ``fees under paragraphs
(1) and (2)'' and inserting ``fee under paragraph (1)''.
(e) Identification of Facilities.--Section 744B(f) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(f)) is amended--
(1) by striking paragraph (1);
(2) by redesignating paragraphs (2) through (4) as paragraphs
(1) through (3), respectively;
(3) in paragraph (1) (as so redesignated)--
(A) by striking ``paragraph (4)'' and inserting
``paragraph (3)''; and
(B) by striking ``Such information shall'' and all
that follows through the end of subparagraph (B) and
inserting ``Such information shall, for each fiscal
year, be submitted, updated, or reconfirmed on or
before June 1 of the previous fiscal year.''; and
(4) in paragraph (2), as so redesignated--
(A) in the heading, by striking ``Contents of
notice'' and inserting ``Information required to be
submitted'';
(B) in the matter preceding subparagraph (A), by
striking ``paragraph (2)'' and inserting ``paragraph
(1)'';
(C) in subparagraph (A), by striking ``or intended to
be identified'';
(D) in subparagraph (D), by striking ``and'' at the
end;
(E) in subparagraph (E), by striking the period and
inserting ``; and''; and
(F) by adding at the end the following:
``(F) whether the facility is a contract
manufacturing organization facility.''.
(f) Effect of Failure To Pay Fees.--Section 744B(g) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379-42(g)) is amended--
(1) in paragraph (1), by adding at the end the following:
``This paragraph shall cease to be effective on October 1,
2022.'';
(2) in paragraph (2)(C)(ii), by striking ``of 505(j)(5)(A)''
and inserting ``of section 505(j)(5)(A)''; and
(3) by adding at the end the following:
``(5) Generic drug applicant program fee.--
``(A) In general.--A person who fails to pay a fee as
required under subsection (a)(5) by the date that is 20
calendar days after the due date, as specified in
subparagraph (D) of such subsection, shall be subject
to the following:
``(i) The Secretary shall place the person on
a publicly available arrears list.
``(ii) Any abbreviated new drug application
submitted by the generic drug applicant or an
affiliate of such applicant shall not be
received, within the meaning of section
505(j)(5)(A).
``(iii) All drugs marketed pursuant to any
abbreviated new drug application held by such
applicant or an affiliate of such applicant
shall be deemed misbranded under section
502(aa).
``(B) Application of penalties.--The penalties under
subparagraph (A) shall apply until the fee required
under subsection (a)(5) is paid.''.
(g) Limitations.--Section 744B(h)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379-42(h)(2)) is amended by striking ``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''.
(h) Crediting and Availability of Fees.--Section 744B(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379-42(i)) is amended--
(1) in paragraph (2)--
(A) by striking subparagraph (C) (relating to fee
collection during first program year);
(B) in subparagraph (D)--
(i) in the heading, by striking ``in
subsequent years''; and
(ii) by striking ``(after fiscal year
2013)''; and
(C) by redesignating subparagraph (D) as subparagraph
(C); and
(2) in paragraph (3), by striking ``fiscal years 2013 through
2017'' and inserting ``fiscal years 2018 through 2022''.
(i) Information on Abbreviated New Drug Applications Owned by
Applicants and Their Affiliates.--Section 744B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379-42) is amended by adding at the
end the following:
``(o) Information on Abbreviated New Drug Applications Owned by
Applicants and Their Affiliates.--
``(1) In general.--By April 1 of each year, each person that
owns an abbreviated new drug application, or any affiliate of
such person, shall submit, on behalf of the person and its
affiliates, to the Secretary a list of--
``(A) all approved abbreviated new drug applications
owned by such person; and
``(B) if any affiliate of such person also owns an
abbreviated new drug application, all affiliates that
own any such abbreviated new drug applications and all
approved abbreviated new drug applications owned by any
such affiliate.
``(2) Format and method.--The Secretary shall specify in
guidance the format and method for submission of lists under
this subsection.''.
SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-43) is amended--
(1) in subsection (a)--
(A) by striking ``2013'' and inserting ``2018''; and
(B) by striking ``Generic Drug User Fee Amendments of
2012'' and inserting ``Generic Drug User Fee Amendments
of 2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018''; and
(3) in subsection (d), by striking ``2017'' each place it
appears and inserting ``2022''.
SEC. 305. SUNSET DATES.
(a) Authorization.--Sections 744A and 744B of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) shall cease to be
effective October 1, 2022.
(b) Reporting Requirements.--Section 744C of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-43) shall cease to be effective
January 31, 2023.
(c) Previous Sunset Provision.--Effective October 1, 2017,
subsections (a) and (b) of section 304 of the Food and Drug
Administration Safety and Innovation Act (Public Law 112-144) are
repealed.
SEC. 306. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 7 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all
abbreviated new drug applications received on or after October 1, 2017,
regardless of the date of the enactment of this Act.
SEC. 307. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 7 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 abbreviated new
drug applications (as defined in such part as of such day) that on or
after October 1, 2012, but before October 1, 2017, were received by the
Food and Drug Administration within the meaning of section 505(j)(5)(A)
of such Act (21 U.S.C. 355(j)(5)(A)), prior approval supplements that
were submitted, and drug master files for Type II active pharmaceutical
ingredients that were first referenced with respect to assessing and
collecting any fee required by such part for a fiscal year prior to
fiscal year 2018.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 401. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Biosimilar User
Fee Amendments of 2017''.
(b) Finding.--The Congress finds that the fees authorized by the
amendments made in this title will be dedicated to expediting the
process for the review of biosimilar biological product applications,
including postmarket safety activities, as set forth in the goals
identified for purposes of part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary
of Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the Chairman
of the Committee on Energy and Commerce of the House of
Representatives, as set forth in the Congressional Record.
SEC. 402. DEFINITIONS.
(a) Adjustment Factor.--Section 744G(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-51(1)) is amended to read as follows:
``(1) The term `adjustment factor' applicable to a fiscal
year is the Consumer Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted;
All items; Annual Index) for October of the preceding fiscal
year divided by such Index for October 2011.''.
(b) Biosimilar Biological Product.--Section 744G(3) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(3)) is amended by
striking ``means a product'' and inserting ``means a specific strength
of a biological product in final dosage form''.
SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.
(a) Types of Fees.--Section 744H(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-52(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``fiscal year 2013'' and inserting ``fiscal year 2018'';
(2) in the heading of paragraph (1), by striking
``Biosimilar'' and inserting ``Biosimilar biological product'';
(3) in paragraph (1)(A)(i), by striking ``(b)(1)(A)'' and
inserting ``(c)(5)'';
(4) in paragraph (1)(B)(i), by striking ``(b)(1)(B) for
biosimilar biological product development'' and inserting
``(c)(5) for the biosimilar biological product development
program'';
(5) in paragraph (1)(B)(ii), by striking ``annual biosimilar
biological product development program fee'' and inserting
``annual biosimilar biological product development fee'';
(6) in paragraph (1)(B)(iii), by striking ``annual biosimilar
development program fee'' and inserting ``annual biosimilar
biological product development fee'';
(7) in paragraph (1)(B), by adding at the end the following:
``(iv) Refund.--If a person submits a
marketing application for a biosimilar
biological product before October 1 of a fiscal
year and such application is accepted for
filing on or after October 1 of such fiscal
year, the person may request a refund equal to
the annual biosimilar development fee paid by
the person for the product for such fiscal
year. To qualify for consideration for a refund
under this clause, a person shall submit to the
Secretary a written request for such refund not
later than 180 days after the marketing
application is accepted for filing.'';
(8) in paragraph (1)(C), by striking ``for a product
effective October 1 of a fiscal year by,'' and inserting ``for
a product, effective October 1 of a fiscal year, by,'';
(9) in paragraph (1)(D)--
(A) in clause (i) in the matter preceding subclause
(I), by inserting ``, if the person seeks to resume
participation in such program,'' before ``pay a fee'';
(B) in clause (i)(I), by inserting after ``grants a
request'' the following: ``by such person''; and
(C) in clause (i)(II), by inserting after
``discontinued)'' the following: ``by such person'';
(10) in the heading of paragraph (1)(E), by striking
``biosimilar development program'';
(11) in paragraph (1)(F)--
(A) in the subparagraph heading, by striking
``biosimilar development program'' before ``fees''; and
(B) by amending clause (i) to read as follows:
``(i) Refunds.--Except as provided in
subparagraph (B)(iv), 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).'';
(12) in paragraph (2)--
(A) in the paragraph heading, by striking ``and
supplement'';
(B) by amending subparagraphs (A) and (B) to read as
follows:
``(A) In general.--Each person that submits, on or
after October 1, 2017, a biosimilar biological product
application shall be subject to the following fees:
``(i) A fee established under subsection
(c)(5) 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.
``(ii) A fee established under subsection
(c)(5) for a biosimilar biological product
application for which clinical data (other than
comparative bioavailability studies) with
respect to safety or effectiveness are not
required for approval. Such fee shall be equal
to half of the amount of the fee described in
clause (i).
``(B) Rule of applicability; treatment of certain
previously paid fees.--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--
``(i) be subject to any biosimilar biological
product application fees that may be assessed
at the time when such biosimilar biological
product application is submitted; and
``(ii) be entitled to no reduction of such
application fees based on the amount of fees
paid for that product before October 1, 2017,
under such subparagraphs (A), (B), or (D).'';
(C) in the heading of subparagraph (D), by striking
``or supplement'';
(D) in subparagraphs (C) through (F), by striking
``or supplement'' each place it appears; and
(E) in subparagraph (D), by striking ``or a
supplement'';
(13) by amending paragraph (3) to read as follows:
``(3) Biosimilar biological product program fee.--
``(A) In general.--Each person who is named as the
applicant in a biosimilar biological product
application shall pay the annual biosimilar biological
product program fee established for a fiscal year under
subsection (c)(5) for each biosimilar biological
product that--
``(i) is identified in such a biosimilar
biological product application approved as of
October 1 of such fiscal year; and
``(ii) as of October 1 of such fiscal year,
does not appear on a list, developed and
maintained by the Secretary, of discontinued
biosimilar biological products.
``(B) Due date.--The biosimilar biological product
program fee for a fiscal year shall be due on the later
of--
``(i) the first business day on or after
October 1 of each such year; or
``(ii) the first business day after the
enactment of an appropriations Act providing
for the collection and obligation of fees for
such year under this section.
``(C) One fee per product per year.--The biosimilar
biological product program fee shall be paid only once
for each product for each fiscal year.
``(D) Limitation.--A person who is named as the
applicant in a biosimilar biological product
application shall not be assessed more than 5
biosimilar biological product program fees for a fiscal
year for biosimilar biological products identified in
such biosimilar biological product application.''.
(b) Fee Revenue Amounts.--Subsection (b) of section 744H of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended to
read as follows:
``(b) Fee Revenue Amounts.--
``(1) Fiscal year 2018.--For fiscal year 2018, fees under
subsection (a) shall be established to generate a total revenue
amount equal to the sum of--
``(A) $45,000,000; and
``(B) the dollar amount equal to the fiscal year 2018
adjustment (as determined under subsection (c)(4)).
``(2) Subsequent fiscal years.--For each of the fiscal years
2019 through 2022, fees under subsection (a) shall, except as
provided in subsection (c), be established to generate a total
revenue amount equal to the sum of--
``(A) the annual base revenue for the fiscal year (as
determined under paragraph (4));
``(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined under
subsection (c)(1));
``(C) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as determined
under subsection (c)(2)); and
``(D) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if applicable
(as determined under subsection (c)(3)).
``(3) Allocation of revenue amount among fees; limitations on
fee amounts.--
``(A) Allocation.--The Secretary shall determine the
percentage of the total revenue amount for a fiscal
year to be derived from, respectively--
``(i) initial and annual biosimilar
development fees and reactivation fees under
subsection (a)(1);
``(ii) biosimilar biological product
application fees under subsection (a)(2); and
``(iii) biosimilar biological product program
fees under subsection (a)(3).
``(B) Limitations on fee amounts.--Until the first
fiscal year for which the capacity planning adjustment
under subsection (c)(2) is effective, the amount of any
fee under subsection (a) for a fiscal year after fiscal
year 2018 shall not exceed 125 percent of the amount of
such fee for fiscal year 2018.
``(C) Biosimilar biological product development
fees.--The initial biosimilar biological product
development fee under subsection (a)(1)(A) for a fiscal
year shall be equal to the annual biosimilar biological
product development fee under subsection (a)(1)(B) for
that fiscal year.
``(D) Reactivation fee.--The reactivation fee under
subsection (a)(1)(D) for a fiscal year shall be equal
to twice the amount of the annual biosimilar biological
product development fee under subsection (a)(1)(B) for
that fiscal year.
``(4) Annual base revenue.--For purposes of paragraph (2),
the dollar amount of the annual base revenue for a fiscal year
shall be the dollar amount of the total revenue amount for the
previous fiscal year, excluding any adjustments to such revenue
amount under subsection (c)(3).''.
(c) Adjustments; Annual Fee Setting.--Section 744H of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended--
(1) by redesignating subsections (c) through (h) as
subsections (d) through (i), respectively;
(2) in subsections (a)(2)(F) and (h) (as redesignated by
paragraph (1)), by striking ``subsection (c)'' and inserting
``subsection (d)'';
(3) in subsection (a)(4)(A), by striking ``subsection
(b)(1)(F)'' and inserting ``subsection (c)(5)''; and
(4) by inserting after subsection (b) the following:
``(c) Adjustments; Annual Fee Setting.--
``(1) Inflation adjustment.--
``(A) In general.--For purposes of subsection
(b)(2)(B), the dollar amount of the inflation
adjustment to the annual base revenue for each fiscal
year shall be equal to the product of--
``(i) such annual base revenue for the fiscal
year under subsection (b); and
``(ii) the inflation adjustment percentage
under subparagraph (B).
``(B) Inflation adjustment percentage.--The inflation
adjustment percentage under this subparagraph for a
fiscal year is equal to the sum of--
``(i) the average annual percent change in
the cost, per full-time equivalent position of
the Food and Drug Administration, of all
personnel compensation and benefits paid with
respect to such positions for the first 3 years
of the preceding 4 fiscal years, multiplied by
the proportion of personnel compensation and
benefits costs to total costs of the process
for the review of biosimilar biological product
applications (as defined in section 744G(13))
for the first 3 years of the preceding 4 fiscal
years; and
``(ii) the average annual percent change that
occurred in the Consumer Price Index for urban
consumers (Washington-Baltimore, DC-MD-VA-WV;
Not Seasonally Adjusted; All items; Annual
Index) for the first 3 years of the preceding 4
years of available data multiplied by the
proportion of all costs other than personnel
compensation and benefits costs to total costs
of the process for the review of biosimilar
biological product applications (as defined in
section 744G(13)) for the first 3 years of the
preceding 4 fiscal years.
``(2) Capacity planning adjustment.--
``(A) In general.--Beginning with the fiscal year
described in subparagraph (B)(ii)(II), the Secretary
shall, in addition to the adjustment under paragraph
(1), further increase the fee revenue and fees under
this section for a fiscal year to reflect changes in
the resource capacity needs of the Secretary for the
process for the review of biosimilar biological product
applications.
``(B) Capacity planning methodology.--
``(i) Development; evaluation and report.--
The Secretary shall obtain, through a contract
with an independent accounting or consulting
firm, a report evaluating options and
recommendations for a new methodology to
accurately assess changes in the resource and
capacity needs of the process for the review of
biosimilar biological product applications. The
capacity planning methodological options and
recommendations presented in such report shall
utilize and be informed by personnel time
reporting data as an input. The report shall be
published for public comment not later than
September 30, 2020.
``(ii) Establishment and implementation.--
After review of the report described in clause
(i) and receipt and review of public comments
thereon, the Secretary shall establish a
capacity planning methodology for purposes of
this paragraph, which shall--
``(I) incorporate such approaches and
attributes as the Secretary determines
appropriate; and
``(II) be effective beginning with
the first fiscal year for which fees
are set after such capacity planning
methodology is established.
``(C) Limitation.--Under no circumstances shall an
adjustment under this paragraph result in fee revenue
for a fiscal year that is less than the sum of the
amounts under subsections (b)(2)(A) (the annual base
revenue for the fiscal year) and (b)(2)(B) (the dollar
amount of the inflation adjustment for the fiscal
year).
``(D) Publication in federal register.--The Secretary
shall publish in the Federal Register notice under
paragraph (5) the fee revenue and fees resulting from
the adjustment and the methodologies under this
paragraph.
``(3) Operating reserve adjustment.--
``(A) Interim application; fee reduction.--Until the
first fiscal year for which the capacity planning
adjustment under paragraph (2) is effective, the
Secretary may, in addition to the adjustment under
paragraph (1), reduce the fee revenue and fees under
this section for a fiscal year as the Secretary
determines appropriate for long-term financial planning
purposes.
``(B) General application and methodology.--Beginning
with the first fiscal year for which the capacity
planning adjustment under paragraph (2) is effective,
the Secretary may, in addition to the adjustments under
paragraphs (1) and (2)--
``(i) reduce the fee revenue and fees under
this section as the Secretary determines
appropriate for long-term financial planning
purposes; or
``(ii) increase the fee revenue and fees
under this section if such an adjustment is
necessary to provide for not more than 21 weeks
of operating reserves of carryover user fees
for the process for the review of biosimilar
biological product applications.
``(C) Federal register notice.--If an adjustment
under subparagraph (A) or (B) is made, the rationale
for the amount of the increase or decrease (as
applicable) in fee revenue and fees shall be contained
in the annual Federal Register notice under paragraph
(5) establishing fee revenue and fees for the fiscal
year involved.
``(4) Fiscal year 2018 adjustment.--
``(A) In general.--For fiscal year 2018, the
Secretary shall adjust the fee revenue and fees under
this section in such amount (if any) as needed to
reflect an updated assessment of the workload for the
process for the review of biosimilar biological product
applications.
``(B) Methodology.--The Secretary shall publish under
paragraph (5) a description of the methodology used to
calculate the fiscal year 2018 adjustment under this
paragraph in the Federal Register notice establishing
fee revenue and fees for fiscal year 2018.
``(C) Limitation.--No adjustment under this paragraph
shall result in an increase in fee revenue and fees
under this section in excess of $9,000,000.
``(5) Annual fee setting.--For fiscal year 2018 and each
subsequent fiscal year, the Secretary shall, not later than 60
days before the start of each such fiscal year--
``(A) establish, for the fiscal year, initial and
annual biosimilar biological product development fees
and reactivation fees under subsection (a)(1),
biosimilar biological product application fees under
subsection (a)(2), and biosimilar biological product
program fees under subsection (a)(3), based on the
revenue amounts established under subsection (b) and
the adjustments provided under this subsection; and
``(B) publish such fee revenue and fees in the
Federal Register.
``(6) Limit.--The total amount of fees assessed for a fiscal
year under this section may not exceed the total costs for such
fiscal year for the resources allocated for the process for the
review of biosimilar biological product applications.''.
(d) Application Fee Waiver for Small Business.--Subsection (d)(1) of
section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-52), as redesignated by subsection (c)(1), is amended--
(1) by striking subparagraph (B);
(2) by striking ``shall pay--'' and all that follows through
``application fees'' and inserting ``shall pay application
fees''; and
(3) by striking ``; and'' at the end and inserting a period.
(e) Effect of Failure To Pay Fees.--Subsection (e) of section 744H of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), as
redesignated by subsection (c)(1), is amended by striking ``all fees''
and inserting ``all such fees''.
(f) Crediting and Availability of Fees.--Subsection (f) of section
744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52),
as redesignated by subsection (c)(1), is amended--
(1) in paragraph (2)--
(A) by striking subparagraph (C) (relating to fee
collection during first program year) and inserting the
following:
``(C) Compliance.--The Secretary shall be considered
to have met the requirements of subparagraph (B) in any
fiscal year if the costs described in such subparagraph
are not more than 15 percent below the level specified
in such subparagraph.''; and
(B) in subparagraph (D)--
(i) in the heading, by striking ``in
subsequent years''; and
(ii) by striking ``(after fiscal year
2013)''; and
(2) in paragraph (3), by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-53) is amended--
(1) in subsection (a)--
(A) by striking ``2013'' and inserting ``2018''; and
(B) by striking ``Biosimilar User Fee Act of 2012''
and inserting ``Biosimilar User Fee Amendments of
2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018'';
(3) by striking subsection (d);
(4) by redesignating subsection (e) as subsection (d); and
(5) in subsection (d), as so redesignated, by striking
``2017'' each place it appears and inserting ``2022''.
SEC. 405. SUNSET DATES.
(a) Authorization.--Sections 744G and 744H of the Federal Food, Drug,
and Cosmetic Act, as amended by section 403 of this Act, shall cease to
be effective October 1, 2022.
(b) Reporting Requirements.--Section 744I of the Federal Food, Drug,
and Cosmetic Act, as amended by section 404 of this Act, shall cease to
be effective January 31, 2023.
(c) Previous Sunset Provision.--
(1) In general.--Effective October 1, 2017, section 404 of
the Food and Drug Administration Safety and Innovation Act
(Public Law 112-144) is repealed.
(2) Conforming amendment.--The Food and Drug Administration
Safety and Innovation Act (Public Law 112-144) is amended in
the table of contents in section 2 by striking the item
relating to section 404.
SEC. 406. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2017, or the date of the enactment of this Act, whichever is later,
except that fees under part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act shall be assessed for all
biosimilar biological product applications received on or after October
1, 2017, regardless of the date of the enactment of this Act.
SEC. 407. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 8 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 biosimilar
biological product 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, 2012, but before
October 1, 2017, with respect to assessing and collecting any fee
required by such part for a fiscal year prior to fiscal year 2018.
TITLE V--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS
SEC. 501. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF
CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.
Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(u)(4)) is amended by striking ``2017'' and inserting
``2022''.
SEC. 502. REAUTHORIZATION OF ORPHAN GRANTS PROGRAM.
Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended
by striking ``2013 through 2017'' and inserting ``2018 through 2022''.
SEC. 503. REAUTHORIZATION OF PEDIATRIC STUDY OF DRUGS.
Section 409I(e)(1) of the Public Health Service Act (42 U.S.C.
284m(e)(1)) is amended by striking ``2013 through 2017'' and inserting
``2018 through 2022''.
SEC. 504. PROTECTING AND STRENGTHENING THE DRUG SUPPLY CHAIN.
(a) Diverted Drugs.--Paragraph (1) of section 801(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended--
(1) by striking ``(d)(1) Except as'' and inserting
``(d)(1)(A) Except as''; and
(2) by adding at the end the following:
``(B) Except as authorized by the Secretary in the case of a drug
that appears on the drug shortage list in effect under section 506E, no
drug that would be subject to section 503(b), and which is manufactured
outside the United States and intended by the manufacturer or labeled
to be marketed outside the United States, may be imported into the
United States for sale or commercial use.''.
(b) Counterfeit Drugs.--Subsection (b) of section 303 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at
the end the following:
``(8) Notwithstanding subsection (a), any person who violates section
301(i)(3) by knowingly making, selling or dispensing, or holding for
sale or dispensing, a counterfeit drug shall be imprisoned for not more
than 10 years or fined in accordance with title 18, United States Code,
or both.''.
SEC. 505. SENSE OF CONGRESS ON LOWERING THE COST OF PRESCRIPTION DRUGS.
It is the sense of the Congress that the Secretary of Health and
Human Services should commit to engaging with the House of
Representatives and the Senate to take administrative actions and enact
legislative changes that--
(1) will lower the cost of prescription drugs for consumers
and reduce the burden of such cost on taxpayers; and
(2) in lowering such cost, will--
(A) balance the need to encourage innovation with the
need to improve affordability; and
(B) strive to increase competition in the
pharmaceutical market, prevent anticompetitive
behavior, and promote the timely availability of
affordable, high-quality generic drugs and biosimilars.
TITLE VI--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS
Subtitle A--Improving the Process for Inspections of Device
Establishments
SEC. 601. RISK-BASED INSPECTIONS FOR DEVICES.
Paragraph (2) of section 510(h) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(h)) is amended to read as follows:
``(2) Risk-based schedule for devices.--
``(A) In general.--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,
propagation, compounding, or processing of a device or
devices (referred to in this subsection as `device
establishments') in accordance with a risk-based
schedule established by the Secretary.
``(B) Factors and considerations.--In establishing
the risk-based schedule under subparagraph (A), the
Secretary shall--
``(i) apply, to the extent applicable for
device establishments, the factors identified
in paragraph (4); and
``(ii) consider the participation of the
device establishment, as applicable, in
international device audit programs in which
the United States participates or which the
United States recognizes for purposes of
inspecting device establishments.''.
SEC. 602. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.
Subsection (a)(1) of section 809 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 384e(a)(1)) is amended by inserting ``or
510(h)(2) (as applicable)'' before the semicolon at the end.
SEC. 603. IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE
ESTABLISHMENTS.
(a) In General.--Section 704 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 374) is amended by adding at the end the following:
``(h)(1) In the case of inspections other than for-cause inspections,
the Secretary shall review processes and standards applicable to
inspections of domestic and foreign device establishments in effect as
of the date of the enactment of this subsection, and update such
processes and standards through the adoption of uniform processes and
standards applicable to such inspections. Such processes and standards
shall provide for--
``(A) exceptions to such processes and standards, as
appropriate;
``(B) announcing the inspection of the establishment within a
reasonable time before such inspection occurs, including by
providing to the owner, operator, or agent in charge of the
establishment a notification regarding the type and nature of
the inspection;
``(C) a reasonable estimate of the timeframe for the
inspection, an opportunity for advance communications between
the officers or employees carrying out the inspection under
subsection (a)(1) and the owner, operator, or agent in charge
of the establishment concerning appropriate working hours
during the inspection, and, to the extent feasible, advance
notice of some records that will be requested in order to
expedite the inspection; and
``(D) regular communications during the inspection with the
owner, operator, or agent in charge of the establishment
regarding inspection status, which may be recorded by either
party with advance notice and mutual consent.
``(2)(A) The Secretary shall, with respect to a request described in
subparagraph (B), provide nonbinding feedback with respect to such
request not later than 45 days after the Secretary receives such
request.
``(B) A request described in this subparagraph is a request for
feedback--
``(i) that is made by the owner, operator, or agent in charge
of such establishment in a timely manner; and
``(ii) with respect to actions proposed to be taken by a
device establishment in a response to a report received by such
establishment pursuant to subsection (b) that involve a public
health priority, that implicate systemic or major actions, or
relate to emerging safety issues (as determined by the
Secretary).
``(3) Nothing in this subsection limits the authority of the
Secretary to conduct inspections otherwise permitted under this Act in
order to ensure compliance with this Act.''.
(b) Guidance.--
(1) Draft guidance.--Not later than 18 months after the date
of enactment of this section, the Secretary of Health and Human
Services shall issue draft guidance that--
(A) specifies how the Food and Drug Administration
will implement the process described in paragraph (1)
of subsection (h) of section 704 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 374), as added by
subsection (a), and the requirements described in
paragraph (2) of such subsection;
(B) provides for standardized methods for
communications described in such paragraphs;
(C) establishes, with respect to inspections of both
domestic and foreign device establishments (as referred
to in section 510(h)(2) of the Federal Food, Drug, and
Cosmetic Act, as amended by subsection (a)), a standard
timeframe for such inspections--
(i) that occurs over consecutive days; and
(ii) to which each investigator conducting
such an inspection shall adhere unless the
investigator identifies to the establishment
involved a reason that more time is needed to
conduct such investigation; and
(D) identifies practices for investigators and device
establishments to facilitate the continuity of
inspections of such establishments.
(2) Final guidance.--Not later than 1 year after providing
notice and opportunity for public comment on the draft guidance
issued under paragraph (1), the Secretary of Health and Human
Services shall issue final guidance to implement subsection (h)
of section 704 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 374), as added by subsection (a).
SEC. 604. CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES.
(a) In General.--Subsection (e)(4) of section 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)) is amended--
(1) by adding at the end the following:
``(E)(i) If the Secretary denies a request made under subparagraph
(A)(ii) for certification with respect to a device, the Secretary shall
provide, in writing, to the person seeking such certification the basis
for such denial, and specifically identify the finding upon which such
denial is based.
``(ii) If the denial of a request as described in clause (i) is based
on--
``(I) grounds other than an injunction proceeding pursuant to
section 302, seizure action pursuant to section 304, or a
recall designated Class I or Class II pursuant to part 7, title
21, Code of Federal Regulations, and
``(II) an establishment being considered out of compliance
with part 820, title 21, Code of Federal Regulations,
the Secretary shall provide a substantive summary of the specific
grounds for noncompliance so identified, if such grounds have not been
previously communicated to the manufacturer.
``(iii) With respect to a device manufactured in an establishment
that has received a report under section 704(b), the Secretary shall
not deny a request for certification under subparagraph (A)(ii) based
exclusively on the issuance of that report if the owner, operator, or
agent in charge of such establishment has agreed to a plan of
correction in response to such report.
``(F)(i) The Secretary shall provide a process for a person who is
denied a certification as described in subparagraph (E)(i) to request a
review that conforms to the standards of section 517A(b).
``(ii) Notwithstanding any previous review conducted pursuant to
clause (i), a person who has been denied a certification for a device
as described in subparagraph (E)(i) may, at any time, request a review
of that denial in order to present new information relating to actions
taken by such person to address the reasons identified by the Secretary
for such denial, including evidence that corrective actions are being
or have been implemented to address the grounds for noncompliance
identified by the Secretary under subparagraph (E)(ii).
``(G)(i) This paragraph applies to requests for certification on
behalf of any device establishment registered under section 510,
whether the establishment is located in the United States or another
country.
``(ii) The Secretary may charge a fee for the issuance of a
certification described in clause (i), and such fee is subject to the
same conditions and requirements as a fee charged under subparagraph
(B) for a certification issued under such subparagraph.''; and
(2) by moving the margins of subparagraphs (C) and (D) 4 ems
to the left.
(b) Guidance.--Not later than 1 year after date of the enactment of
this section, the Secretary of Health and Human Services shall issue
guidance providing for a process to carry out subparagraph (F) of
section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 381(e)(4)), as added by subsection (a). Not later than 12 months
after the comment period closes for the draft guidance, the Secretary
shall issue final guidance.
SEC. 605. FACILITATING INTERNATIONAL HARMONIZATION.
Section 704(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
374(g)) is amended by adding at the end the following:
``(15) Notwithstanding any other provision of this subsection, for
purposes of conducting inspections of establishments that manufacture,
prepare, propagate, compound, or process devices except types of
devices licensed under section 351 of the Public Health Service Act,
which inspections are required under section 510(h) or are inspections
of such establishments required to register pursuant to section 510(i),
the Secretary may recognize auditing organizations that are recognized
by organizations established by governments to facilitate international
harmonization. Nothing in this paragraph affects the authority of the
Secretary to inspect any device establishment pursuant to this Act.
Nothing in this paragraph affects the authority of the Secretary to
determine the official classification of an inspection.''.
SEC. 606. REAUTHORIZATION OF INSPECTION PROGRAM.
Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 374(g)(11)) is amended by striking ``October 1, 2017'' and
inserting ``October 1, 2022''.
Subtitle B--Other Provisions
SEC. 611. REAUTHORIZATION OF PEDIATRIC HUMANITARIAN DEVICE EXCEPTIONS.
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 ``2017'' and
inserting ``2022''.
SEC. 612. REAUTHORIZATION OF PEDIATRIC DEVICE CONSORTIA.
Section 305(e) of the Pediatric Medical Device Safety and Improvement
Act of 2007 (Public Law 110-85; 42 U.S.C. 282 note)) is amended by
striking ``2013 through 2017'' and inserting ``2018 through 2022''.
SEC. 613. REGULATION OF OVER-THE-COUNTER HEARING AIDS.
(a) In General.--Section 520 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360j) is amended by adding at the end the following:
``(p) Regulation of Over-the-Counter Hearing Aids.--
``(1) Definition.--
``(A) In this subsection, the term `over-the-counter
hearing aid' means a device--
``(i) that uses the same fundamental
scientific technology as air conduction hearing
aids (as defined in section 874.3300 of title
21, Code of Federal Regulations) (or any
successor regulation) or wireless air
conduction hearing aids (as defined in section
874.3305 of title 21, Code of Federal
Regulations) (or any successor regulation);
``(ii) that is intended to be used by adults
over the age of 18 to compensate for perceived
mild to moderate hearing impairment;
``(iii) that, through tools, tests, or
software, allows the user to control the over-
the-counter hearing aid and customize it to the
user's hearing needs;
``(iv) that may--
``(I) use wireless technology; or
``(II) include tests for self-
assessment of hearing loss; and
``(v) that is available over-the-counter,
without the supervision, prescription, or other
order, involvement, or intervention of a
licensed person, to consumers through in-person
transactions, by mail, or online.
``(B) Such term does not include a personal sound
amplification product intended to amplify sound for
nonhearing impaired consumers in situations including
hunting and bird-watching.
``(2) Regulation.--An over-the-counter hearing aid shall be
subject to the regulations promulgated in accordance with
section 613(b) of the FDA Reauthorization Act of 2017 and shall
be exempt from sections 801.420 and 801.421 of title 21, Code
of Federal Regulations (or any successor regulations).''.
(b) Regulations To Establish Category.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), not later
than 3 years after the date of enactment of this Act, shall
promulgate proposed regulations to establish a category of
over-the-counter hearing aids, as defined in subsection (p) of
section 520 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360j) as amended by subsection (a), and, not later than
180 days after the date on which the public comment period on
the proposed regulations closes, shall issue such final
regulations.
(2) Requirements.--In promulgating the regulations under
paragraph (1), the Secretary shall--
(A) include requirements that provide reasonable
assurances of the safety and efficacy of over-the-
counter hearing aids;
(B) include requirements that establish or adopt
output limits appropriate for over-the-counter hearing
aids;
(C) include requirements for appropriate labeling of
the over-the-counter hearing aid, including
requirements that such labeling include a conspicuous
statement that the device is only intended for adults
over the age of 18, information on how consumers may
report adverse events, information on any
contraindications, conditions, or symptoms of medically
treatable causes of hearing loss, and advisements to
consult promptly with a licensed physician; and
(D) describe the requirements under which the sale of
over-the-counter hearing aids is permitted, without the
supervision, prescription, or other order, involvement,
or intervention of a licensed person, to consumers
through in-person transactions, by mail, or online.
(3) Premarket notification.--The Secretary shall make
findings under section 510(m) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(m)) to determine whether over-the-
counter hearing aids (as defined in section 520(p) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as
amended by subsection (a)) require a report under section
510(k) to provide reasonable assurance of safety and
effectiveness.
(4) Effect on state law.--No State or local government shall
establish or continue in effect any law, regulation, order, or
other requirement specifically related to hearing products that
would restrict or interfere with the servicing, marketing,
sale, dispensing, use, customer support, or distribution of
over-the-counter hearing aids (as defined in section 520(p) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as
amended by subsection (a)) through in-person transactions, by
mail, or online, that is different from, in addition to, or
otherwise not identical to, the regulations promulgated under
this subsection, including any State or local requirement for
the supervision, prescription, or other order, involvement, or
intervention of a licensed person for consumers to access over-
the-counter hearing aids.
(5) No effect on private remedies.--Nothing in this section
shall be construed to modify or otherwise affect the ability of
any person to exercise a private right of action under any
State or Federal product liability, tort, warranty, contract,
or consumer protection law.
(c) New Guidance Issued.--Not later than the date on which final
regulations are issued under subsection (b), the Secretary shall update
and finalize the draft guidance of the Department of Health and Human
Services entitled ``Regulatory Requirements for Hearing Aid Devices and
Personal Sound Amplification Products'', issued on November 7, 2013.
Such updated and finalized guidance shall clarify which products, on
the basis of claims or other marketing, advertising, or labeling
material, meet the definition of a device in section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321) and which products meet
the definition of a personal sound amplification product, as set forth
in such guidance.
(d) Report.--Not later than 2 years after the date on which the final
regulations described in subsection (b)(1) are issued, the Secretary of
Health and Human Services shall submit to Congress a report analyzing
any adverse events relating to over-the-counter hearing aids (as
defined in subsection (p)(1) of section 520 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360j)).
SEC. 614. REPORT ON ENSURING QUALITY, SAFETY, AND CONTINUED
EFFECTIVENESS OF DEVICES THAT HAVE BEEN SERVICED.
(a) In General.--Not later than 180 days after the date of enactment
of this Act, the Secretary of Health and Human Services, acting through
the Commissioner of Food and Drugs, 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 how
the Food and Drug Administration intends to ensure the quality, safety,
and continued effectiveness of devices (as defined in section 201(h) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301(h))) with
respect to which servicing (as defined in subsection (c)) has been
performed by any entity engaging in such servicing.
(b) Contents.--The report submitted under subsection (a) shall
contain--
(1) the status of, and findings to date with respect to, the
notice entitled ``Refurbishing, Reconditioning, Rebuilding,
Remarketing, Remanufacturing, and Servicing of Medical Devices
Performed by Third-Party Entities and Original Equipment
Manufacturers; Request for Comments'' published by the Food and
Drug Administration on April 25, 2016 (81 Fed. Reg. 24041 et
seq.), including how the Food and Drug Administration intends
to define the specific activities performed on a device by the
manufacturer of the device or other entities;
(2) a description of the statutory or regulatory authority of
the Food and Drug Administration used to oversee and regulate
servicing conducted with respect to devices;
(3) details on how the Food and Drug Administration intends
to protect the public health by ensuring consistent quality,
safety, and continued effectiveness of devices with respect to
which servicing has been performed by any entity engaging in
such servicing;
(4) information on how the Food and Drug Administration can
better understand the device servicing industry, including the
size, scope, location, and composition of entities performing
such servicing and the rate of adverse events related to such
servicing;
(5) information regarding the current regulation by States,
the Joint Commission, or other regulatory bodies of servicing
conducted with respect to devices by all entities, including
original equipment manufacturers, third-party entities, and
hospitals; and
(6) any additional information determined by the Secretary
(acting through the Commissioner) to be relevant to ensuring
the quality, safety, and continued effectiveness of devices
with respect to which servicing has been performed, including
whether additional Federal statutory authority is necessary to
ensure such quality, safety, and continued effectiveness.
(c) Servicing Defined.--In this section, the term ``servicing''
includes, with respect to a device, refurbishing, reconditioning,
rebuilding, remarketing, remanufacturing, repairing, or other servicing
of the device by a person other than the manufacturer of the device.
SEC. 615. DEVICE PILOT PROJECTS TO GENERATE RELIABLE AND TIMELY SAFETY
AND ACTIVE SURVEILLANCE DATA.
(a) In General.--Section 519 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360i) is amended by adding at the end the following:
``(i) Pilot Projects To Generate Reliable and Timely Safety and
Active Surveillance Data.--
``(1) In general.--The Secretary shall, not later than one
year after the date of the enactment of the FDA Reauthorization
Act of 2017, initiate one or more pilot projects relating to
providing timely and reliable information on the safety and
effectiveness of devices approved under section 515, cleared
under section 510(k), or classified under section 513(f)(2), in
which a manufacturer or manufacturers of a device or device
type voluntarily participate. Any such project shall meet each
of the following criteria:
``(A) The project is designed to efficiently generate
reliable and timely safety and active surveillance data
for use by the Secretary or manufacturers of the
devices that are involved in the pilot project.
``(B) The project informs, to the extent applicable,
the development of methods, systems, data criteria, and
programs that could be used to support safety and
active surveillance activities for any device.
``(C) The project shall be designed and conducted in
coordination with a comprehensive system for evaluating
device technology that operates under a governing board
with appropriate representation of stakeholders,
including patient groups and device manufacturers.
``(D) The project uses electronic health data
including, as appropriate, claims data, patient survey
data, and any other data, as the Secretary determines
appropriate.
``(E) The project prioritizes devices and device
types that meet one or more of the following criteria:
``(i) Devices and device types for which the
collection and analysis of real world evidence
regarding a device's safety and effectiveness
is likely to advance public health.
``(ii) Devices and device types that are
widely used.
``(iii) Devices and device types, the failure
of which has significant health consequences.
``(iv) Devices and device types for which the
Secretary--
``(I) has received public
recommendations in accordance with
paragraph (2)(B); and
``(II) has determined to meet one of
the criteria under clause (i), (ii), or
(iii) and is appropriate for such a
pilot project.
``(2) Participation.--The Secretary shall establish the
conditions and processes--
``(A) under which a manufacturer of a device may
voluntarily participate in a pilot project described in
paragraph (1); and
``(B) for facilitating public recommendations for
devices to be prioritized under such a pilot project,
including requirements for the data necessary to
support such a recommendation.
``(3) Continuation of ongoing projects.--The Secretary may
continue or expand projects, with respect to providing timely
and reliable information on the safety and effectiveness of
devices approved under section 515, cleared under section
510(k), or classified under section 513(f)(2), that are being
carried out as of the date of the enactment of the FDA
Reauthorization Act of 2017. The Secretary shall, beginning on
such date of enactment, take such steps as may be necessary--
``(A) to ensure such projects meet the requirements
of subparagraphs (A) through (E) of paragraph (1); and
``(B) to increase the voluntary participation in such
projects of manufacturers of devices and facilitate
public recommendations for any devices prioritized
under such a project.
``(4) Implementation.--
``(A) Contracting authority.--The Secretary may carry
out a pilot project meeting the criteria specified in
subparagraphs (A) through (E) of paragraph (1) or a
project continued or expanded under paragraph (3) by
entering into contracts, cooperative agreements,
grants, or other appropriate agreements with public or
private entities that have a significant presence in
the United States and meet the following conditions:
``(i) If such an entity is a component of
another organization, the entity and the
organization have established an agreement
under which appropriate security measures are
implemented to maintain the confidentiality and
privacy of the data described in paragraph
(1)(D) and such agreement ensures that the
entity will not make an unauthorized disclosure
of such data to the other components of the
organization in breach of requirements with
respect to confidentiality and privacy of such
data established under such security measures.
``(ii) In the case of the termination or
nonrenewal of such a contract, cooperative
agreement, grant, or other appropriate
agreement, the entity or entities involved
shall comply with each of the following:
``(I) The entity or entities shall
continue to comply with the
requirements with respect to
confidentiality and privacy referred to
in clause (i) under this subparagraph
with respect to all data disclosed to
the entity under such an agreement.
``(II) The entity or entities shall
return any data disclosed to such
entity pursuant to this subsection and
to which it would not otherwise have
access or, if returning such data is
not practicable, destroy the data.
``(iii) The entity or entities shall have one
or more qualifications with respect to--
``(I) research, statistical,
epidemiologic, or clinical capability
and expertise to conduct and complete
the activities under this subsection,
including the capability and expertise
to provide the Secretary access to de-
identified data consistent with the
requirements of this subsection;
``(II) an information technology
infrastructure to support electronic
data and operational standards to
provide security for such data, as
appropriate;
``(III) experience with, and
expertise on, the development of
research on, and surveillance of,
device safety and effectiveness using
electronic health data; or
``(IV) such other expertise which the
Secretary determines necessary to carry
out such a project.
``(B) Review of contract in the event of a merger or
acquisition.--The Secretary shall review any contract,
cooperative agreement, grant, or other appropriate
agreement entered into under this paragraph with an
entity meeting the conditions specified in subparagraph
(A) in the event of a merger or acquisition of the
entity in order to ensure that the requirements
specified in this subsection will continue to be met.
``(5) Compliance with requirements for records or reports on
devices.--The participation of a manufacturer in pilot projects
under this subsection shall not affect the eligibility of such
manufacturer to participate in any quarterly reporting program
with respect to devices carried out under section 519 or 522.
The Secretary may determine that, for a specified time period
to be determined by the Secretary, a manufacturer's
participation in a pilot project under this subsection or a
project continued or expanded under paragraph (3) may meet the
applicable requirements of section 519 or 522, if--
``(A) the project has demonstrated success in
capturing relevant adverse event information; and
``(B) the Secretary has established procedures for
making adverse event and safety information collected
from such project public, to the extent possible.
``(6) Privacy requirements.--With respect to the disclosure
of any health information collected through a project conducted
under this subsection--
``(A) individually identifiable health information so
collected shall not be disclosed when presenting any
information from such project; and
``(B) any such disclosure shall be made in compliance
with regulations issued pursuant to section 264(c) of
the Health Insurance Portability and Accountability Act
of 1996 (42 U.S.C. 1320d-2 note) and sections 552 and
552a of title 5, United States Code.
``(7) Limitations.--
``(A) In general.--No pilot project under this
subsection undertaken in coordination with the
comprehensive system described in paragraph (1)(C),
shall allow for an entity participating in such
program, other than the Secretary or the Secretary's
designee, to make determinations of safety or
effectiveness, or substantial equivalence, for purposes
of the Act.
``(B) No use of fees.--Pilot projects initiated under
this subsection may not primarily utilize funds
collected pursuant to the Medical Device User Fee
Amendments of 2017.
``(8) Other projects required to comply.--Paragraphs (1)(B),
(4)(A)(i), (4)(A)(ii), (5), and (6) shall apply with respect to
any pilot program undertaken in coordination with the
comprehensive system described in paragraph (1)(C) that relates
to the use of real world evidence for devices in the same
manner and to the same extent as such paragraphs apply with
respect to pilot projects conducted under this subsection.
``(9) Report to congress.--Not later than 18 months after the
date of enactment of this Act, and annually 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 containing
a description of the pilot projects being conducted under this
subsection and projects continued or expanded pursuant to
paragraph (3), including for each such project--
``(A) how the project is being implemented in
accordance with paragraph (4), including how such
project is being implemented through a contract,
cooperative agreement, grant, or other appropriate
agreement, if applicable;
``(B) the number of manufacturers that have agreed to
participate in such project;
``(C) the data sources used to conduct such project;
``(D) the devices or device categories involved in
such project;
``(E) the number of patients involved in such
project; and
``(F) the findings of the project in relation to
device safety, including adverse events, malfunctions,
and other safety information.
``(10) Sunset.--The Secretary may not carry out a pilot
project initiated by the Secretary under this subsection after
October 1, 2022.''.
(b) Report.--Not later than January 31, 2021, the Secretary of Health
and Human Services, acting through the Commissioner of Food and Drugs,
may conduct a review through an independent third party to evaluate
the strengths, limitations, and appropriate use of evidence collected
pursuant to real world evidence pilot projects described in the letters
described in section 201(b) of the Medical Device User Fee Amendments
of 2017 and subsection (i) of section 519 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360i), as added by subsection (a)--
(1) for purposes of informing premarket and postmarket
decisionmaking for multiple device types; and
(2) to determine whether the methods, systems, and programs
carried out through such pilot projects efficiently generate
reliable and timely evidence about the effectiveness of the
surveillance of devices with respect to safety.
SEC. 616. RISK-BASED CLASSIFICATION OF ACCESSORIES.
(a) In General.--Subsection (f) of section 513 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end
the following new paragraph:
``(6)(A) Subject to the succeeding subparagraphs of this paragraph,
the Secretary shall, by written order, classify an accessory under this
section based on the risks of the accessory when used as intended and
the level of regulatory controls necessary to provide a reasonable
assurance of safety and effectiveness of the accessory, notwithstanding
the classification of any other device with which such accessory is
intended to be used.
``(B) The classification of any accessory distinct from another
device by regulation or written order issued prior to December 13,
2016, shall continue to apply unless and until the accessory is
reclassified by the Secretary, notwithstanding the classification of
any other device with which such accessory is intended to be used.
Nothing in this section shall preclude the Secretary's ability to
initiate the classification of an accessory through regulation or
written order, as appropriate.
``(C)(i) In the case of an accessory that has been granted marketing
authorization as part of a submission under section 515(c), 510(k), or
paragraph (2) of this subsection with another device with which such
accessory is intended to be used, and with respect to which the
Secretary has issued a written order classifying such accessory type
distinct from another device in accordance with subparagraph (A), the
manufacturer or importer of such accessory may, in lieu of submitting a
request for classification of such accessory, submit a written request
to the Secretary identifying such classification. A request under this
clause shall include such information to support the request as may be
specified by the Secretary.
``(ii) A request under clause (i) shall include a recommendation for
the proper classification of the accessory pursuant to subparagraph
(A), and shall include such information as may be necessary for the
Secretary to evaluate, based on the least burdensome approach, the
appropriate class for the accessory under subsection (a).
``(iii) The Secretary shall respond to a request under clause (i)
within 90 calendar days by granting or denying the request for
reclassification of the accessory.
``(iv) Within 30 calendar days after granting a request submitted
under clause (i), the Secretary shall publish a notice in the Federal
Register announcing such response.
``(v) A written notification that the Secretary disagrees with the
classification recommended in a request pursuant to clause (ii) shall
include a detailed description and justification for the determination
to disagree.
``(D)(i) In the case of a device intended to be used with an
accessory, where the accessory has been included in an application for
premarket approval of such device under section 515 or a report under
section 510(k) for clearance of such device and the Secretary has not
classified such accessory distinctly from another device in accordance
with subparagraph (A), the person filing the application or report (as
applicable) at the time such application or report is filed--
``(I) may include a written request for the proper
classification of the accessory pursuant to subparagraph (A);
``(II) shall include in any such request such information as
may be necessary for the Secretary to evaluate, based on the
least burdensome approach, the appropriate class for the
accessory under subsection (a); and
``(III) shall, if the request under subclause (I) is
requesting classification of the accessory in class II, include
in the application an initial draft proposal for special
controls, if special controls would be required pursuant to
subsection (a)(1)(B).
``(ii) The Secretary's response under section 515(d) or section
510(n) (as applicable) to an application or report described in clause
(i) shall also contain the Secretary's granting or denial of the
request for classification of the accessory involved.
``(iii) The Secretary's evaluation of an accessory under clause (i)
shall constitute an order establishing a new classification for such
accessory for the specified intended use or uses of such accessory and
for any accessory with the same intended use or uses as such accessory.
``(E) For accessories that have been granted marketing authorization
as part of a submission for another device with which the accessory
involved is intended to be used, through an application for such other
device under section 515(c), a report under section 510(k), or a
request for classification under paragraph (2) of this subsection, and
that have not been classified by the Secretary based on the risks and
appropriate level of regulatory controls in accordance with
subparagraph (A):
``(i) Not later than the date that is one year after the date
of enactment of the FDA Reauthorization Act of 2017 and at
least once every 5 years thereafter, and as the Secretary
otherwise deems appropriate, pursuant to this paragraph, the
Secretary shall publish in the Federal Register a notice
proposing a list of such accessories that the Secretary
believes may be suitable for a distinct classification in class
I and the proposed regulations for such classifications. In
developing such lists, the Secretary shall consider
recommendations from sponsors of device submissions and other
stakeholders for accessories to be included on such lists. The
notices shall provide for a period of not less than 60 calendar
days for public comment. Within 180 days after the end of the
comment period, the Secretary shall publish in the Federal
Register a final action classifying such suitable accessories
into class I.
``(ii) A manufacturer or importer of an accessory that has
been granted such marketing authorization may submit to the
Secretary a written request for the appropriate classification
of the accessory based on the risks and appropriate level of
regulatory controls as described in subparagraph (A) or (C),
and shall, if the request is requesting classification of the
accessory in class II, include in the submission an initial
draft proposal for special controls, if special controls would
be required pursuant to subsection (a)(1)(B). Such request
shall include such information as may be necessary for the
Secretary to evaluate, based on the least burdensome approach,
the appropriate class for the accessory under subsection (a).
The Secretary shall provide an opportunity for a manufacturer
or importer to meet with appropriate personnel of the Food and
Drug Administration to discuss the appropriate classification
of such accessory prior to submitting a written request under
this clause for classification of the accessory.
``(iii) The Secretary shall respond to a request made under
clause (ii) not later than 90 calendar days after receiving
such submission by granting or denying the request for
classification of the accessory, and the Secretary shall by
written order classify such accessory or deny the request. If
the Secretary does not agree with the recommendation for
classification submitted by the manufacturer or importer, the
response shall include a detailed description and justification
for such determination. Within 30 calendar days after granting
such a request, the Secretary shall publish a notice in the
Federal Register announcing such response.
``(F) Nothing in this paragraph may be construed as precluding a
manufacturer of an accessory of a new type from using the
classification process described in subsection (f)(2) to obtain
classification of such accessory in accordance with the criteria and
requirements set forth in that subsection.''.
(b) Conforming Change.--Section 513(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c(b)) is amended by striking paragraph (9)
(relating to classification of an accessory).
(c) Effective Date.--The amendments made by subsections (a) and (b)
shall take effect on the date that is 60 days after the date of
enactment of this Act.
TITLE VII--GENERIC DRUG ACCESS AND COMPETITION
SEC. 701. COMPETITIVE GENERIC THERAPIES.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506G
the following:
``SEC. 506H. COMPETITIVE GENERIC THERAPIES.
``(a) In General.--The Secretary shall, at the request of the sponsor
of a drug that is designated as a competitive generic therapy pursuant
to subsection (b), expedite the development and review of such drug
pursuant to section 505(j).
``(b) Designation Process.--
``(1) Request.--The sponsor of a drug may request the
Secretary to designate the drug as a competitive generic
therapy.
``(2) Timing.--A request under paragraph (1) may be made
concurrently with, or at any time prior to, the submission of
an abbreviated new drug application for the drug under section
505(j).
``(3) Criteria.--A drug is eligible for designation as a
competitive generic therapy under this section if the Secretary
determines that there is inadequate generic competition.
``(4) Designation.--Not later than 60 calendar days after the
receipt of a request under paragraph (1), the Secretary shall--
``(A) determine whether the drug that is the subject
of the request meets the criteria described in
paragraph (3); and
``(B) if the Secretary finds that the drug meets such
criteria, designate the drug as a competitive generic
therapy.
``(c) Actions.--In expediting the development and review of a drug
under subsection (a), the Secretary shall, as requested by the sponsor,
take actions including the following:
``(1) Hold meetings with the sponsor and the review team
throughout the development of the drug prior to submission of
the application for such drug under section 505(j).
``(2) Provide timely advice to, and interactive communication
with, the sponsor regarding the development of the drug to
ensure that the development program to gather the data
necessary for approval is as efficient as practicable.
``(3) Involve senior managers and experienced review staff,
as appropriate, in a collaborative, coordinated review,
including with respect to drug-device combination products and
other complex products.
``(4) Assign a cross-disciplinary project lead for the Food
and Drug Administration review team--
``(A) to facilitate an efficient review of the
development program and application, including
manufacturing inspections; and
``(B) to serve as a scientific liaison between the
review team and the sponsor.
``(d) Definitions.--In this section:
``(1) The term `generic drug' means a drug that is approved
pursuant to section 505(j).
``(2) The term `inadequate generic competition' means, with
respect to a product, there is not more than one approved drug
product on the list of products described in section
505(j)(7)(A) (not including products on the discontinued
section of such list) that is--
``(A) the reference listed drug; or
``(B) a generic drug with the same reference listed
drug as the drug for which designation as a competitive
generic therapy is sought.
``(3) The term `reference listed drug' means the listed drug
(as such term is used in section 505(j)) for the drug
involved.''.
(b) Guidance; Amended Regulations.--
(1) In general.--
(A) Issuance.--The Secretary of Health and Human
Services shall--
(i) not later than 18 months after the date
of enactment of this Act, issue draft guidance
on the provisions of section 506H of the
Federal Food, Drug, and Cosmetic Act, as added
by subsection (a); and
(ii) not later than 1 year after the close of
the comment period for the draft guidance,
issue final guidance on such provisions.
(B) Contents.--The guidance issued under this
subsection shall--
(i) specify the process and criteria by which
the Secretary makes a designation under section
506H of the Federal Food, Drug, and Cosmetic
Act, as added by subsection (a);
(ii) specify the actions the Secretary will
take to expedite the development and review of
a competitive generic therapy pursuant to such
a designation; and
(iii) include good review management
practices for competitive generic therapies.
(2) Amended regulations.--
(A) In general.--If the Secretary of Health and Human
Services determines that it is necessary to amend the
regulations under title 21, Code of Federal
Regulations, in order to implement section 506H of the
Federal Food, Drug, and Cosmetic Act, as added by
subsection (a), the Secretary shall amend such
regulations not later than 2 years after the date of
enactment of this Act.
(B) Procedure.--In carrying out subparagraph (A), and
in issuing any other regulations to implement such
section 506H, the Secretary shall--
(i) issue a notice of proposed rulemaking
that includes the proposed regulation;
(ii) provide a period of not less than 60
days for comments on the proposed regulation;
and
(iii) publish the final regulation not less
than 30 days before the effective date of the
regulation.
SEC. 702. ENHANCING REGULATORY TRANSPARENCY TO ENHANCE GENERIC
COMPETITION.
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) is amended by adding at the end the following:
``(11) Upon the request of an applicant regarding one or more
specified pending applications under this subsection, the Secretary
shall--
``(A) by telephone or electronic mail, provide review status
updates; and
``(B) indicate in such updates the categorical status of the
applications by each relevant review discipline.''.
SEC. 703. INCENTIVIZING COMPETITIVE GENERIC THERAPY DEVELOPMENT.
Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(5)) is amended--
(1) in subparagraph (B), by adding at the end the following:
``(v) 180-day exclusivity period for competitive generic
therapies.--
``(I) Effectiveness of application.--Subject to
subparagraph (D)(iv), if the application is for a drug
that is the same as a competitive generic therapy for
which any first approved applicant has commenced
commercial marketing, the application shall be made
effective on the date that is 180 days after the date
of the first commercial marketing of the competitive
generic therapy (including the commercial marketing of
the listed drug) by any first approved applicant.
``(II) Limitation.--The exclusivity period under
subclause (I) shall not apply with respect to a
competitive generic therapy that has previously
received an exclusivity period under subclause (I).
``(III) Definitions.--In this clause and subparagraph
(D)(iv):
``(aa) The term `competitive generic therapy'
means a drug--
``(AA) that is designated as a
competitive generic therapy under
section 506H; and
``(BB) for which there are no
unexpired patents or blocking
exclusivities on the list of products
described in section 505(j)(7)(A) at
the time of approval.
``(bb) The term `first approved applicant'
means any applicant that has submitted an
application that--
``(AA) is for a competitive generic
therapy that is approved on the first
day on which any application for such
competitive generic therapy is
approved;
``(BB) is not eligible for a 180-day
exclusivity period under clause (iv)
for the drug that is the subject of the
application for the competitive generic
therapy; and
``(CC) is not for a drug for which
all drug versions have forfeited
eligibility for a 180-day exclusivity
period under clause (iv) pursuant to
subparagraph (D).''; and
(2) in subparagraph (D), by adding at the end the following:
``(iv) Special forfeiture rule for
competitive generic therapy.--The 180-day
exclusivity period described in subparagraph
(B)(v) shall be forfeited by a first approved
applicant if the applicant fails to market the
competitive generic therapy within 75 days
after the date on which the approval of the
first approved applicant's application for the
competitive generic therapy is made
effective.''.
SEC. 704. TROPICAL DISEASE PRODUCT APPLICATION.
Subparagraph (A) of section 524(a)(4) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360n(a)(4)) is amended--
(1) in clause (i), by striking ``and'' at the end; and
(2) by adding at the end the following:
``(iii) that contains reports of one or more
new clinical investigations (other than
bioavailability studies) that are essential to
the approval of the application and conducted
or sponsored by the sponsor of such
application; and
``(iv) that contains an attestation from the
sponsor of the application that such reports
were not submitted as part of an application
for marketing approval or licensure by a
regulatory authority in India, Brazil,
Thailand, or any country that is a member of
the Pharmaceutical Inspection Convention or the
Pharmaceutical Inspection Cooperation Scheme
prior to September 27, 2007.''.
SEC. 705. GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS OF
GENERIC MEDICINES.
(a) Study by GAO.--The Comptroller General of the United States shall
conduct a study to determine the following:
(1) The rate of first cycle approvals and tentative approvals
for generic drug applications submitted during the period
beginning on October 1, 2012, and ending on September 30, 2017.
The rate of first cycle approvals and tentative approvals shall
be determined and reported per each GDUFA cohort year during
this period.
(2) If the rate determined pursuant to paragraph (1) for any
GDUFA cohort year is lower than 20 percent, the reasons
contributing to the relatively low rate of first cycle
approvals and tentative approvals for generic drug applications
shall be itemized, assessed, and reported. In making the
assessment required by this paragraph, the Comptroller General
shall consider, among other things, the role played by--
(A) the Food and Drug Administration's implementation
of approval standards for generic drug applications;
(B) the extent to which those approval standards are
communicated clearly to industry and applied
consistently during the review process;
(C) the procedures for reviewing generic drug
applications, including timelines for review activities
by the Food and Drug Administration;
(D) the extent to which those procedures are followed
consistently (and those timelines are met) by the Food
and Drug Administration;
(E) the processes and practices for communication
between the Food and Drug Administration and sponsors
of generic drug applications; and
(F) the completeness and quality of original generic
drug applications submitted to the Food and Drug
Administration.
(3) Taking into account the determinations made pursuant to
paragraphs (1) and (2) and any review process improvements
implemented pursuant to this Act, whether there are ways the
review process for generic drugs could be improved to increase
the rate of first cycle approvals and tentative approvals for
generic drug applications. In making this determination, the
Comptroller General shall consider, among other things, options
for increasing review efficiency and communication
effectiveness.
(b) Completion Date.--Not later than the expiration of the 2-year
period beginning on the date of enactment of this Act, the Comptroller
General shall complete the study under subsection (a) and submit a
report describing the findings and conclusions of the study to the
Secretary, the Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education, Labor, and
Pensions of the Senate.
(c) Definitions.--For purposes of this section:
(1) The term ``GDUFA cohort year'' means a fiscal year.
(2) The term ``generic drug'' means a drug that is approved
or is seeking approval under section 505(j) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).
(3) The term ``generic drug application'' means an
abbreviated new drug application for the approval of a generic
drug under section 505(j) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)).
(4) The term ``Secretary'' means the Secretary of Health and
Human Services.
(5)(A) The term ``first cycle approvals and tentative
approvals'' means the approval or tentative approval of a
generic drug application after the Food and Drug
Administration's complete review of the application and without
issuance of one or more complete response letters.
(B) For purposes of this paragraph, the term ``complete
response letter'' means a written communication to the sponsor
of a generic drug application or holder of a drug master file
(DMF) from the Food and Drug Administration describing all of
the deficiencies that the Administration has identified in the
generic drug application (including pending amendments) or drug
master file that must be satisfactorily addressed before the
generic drug application can be approved.
TITLE VIII--FOSTERING INNOVATION IN MEDICAL IMAGING
SEC. 801. APPROVAL OF APPLICATIONS FOR CERTAIN DIAGNOSTIC MEDICAL
IMAGING DEVICES.
Section 520 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C.
360j), as amended by section 613, is further amended by adding at the
end the following:
``(q) Diagnostic Imaging Devices Intended for Use With Contrast
Agents.--
``(1) The Secretary may, subject to the succeeding provisions
of this subsection, approve an application (or a supplement to
such an application) submitted under section 515 with respect
to an applicable medical imaging device, or, in the case of an
applicable medical imaging device for which a notification is
submitted under section 510(k), may make a substantial
equivalence determination with respect to an applicable medical
imaging device, or may grant a request submitted under section
513(f)(2) for an applicable medical imaging device, if the
indications and conditions of use proposed in such application,
notification, or request involve the use of a contrast agent
that is not--
``(A) in a concentration, rate of administration, or
route of administration that is different from those
described in the approved labeling of the contrast
agent, except that the Secretary may approve such
application, make such substantial equivalence
determination, or grant such request if the Secretary
determines that such differences in concentration, rate
of administration, or route of administration exist but
do not adversely affect the safety and effectiveness of
the contrast agent when used with the device;
``(B) in a region, organ, or system of the body that
is different from those described in the approved
labeling of the contrast agent, except that the
Secretary may approve such application, make such
substantial equivalence determination, or grant such
request if the Secretary determines that such
differences in region, organ, or system of the body
exist but do not adversely affect the safety and
effectiveness of the contrast agent when used with the
device;
``(C) in a patient population that is different from
those described in the approved labeling of the
contrast agent, except that the Secretary may approve
such application, make such substantial equivalence
determination, or grant such request if the Secretary
determines such differences in patient population exist
but do not adversely affect the safety and
effectiveness of the contrast agent when used with the
device; or
``(D) in an imaging modality (such as an ultrasound,
an x-ray, diagnostic radiopharmaceutical-based
technologies, fluorescent imaging technology, or
magnetic resonance) that is different from those
described in the approved labeling of the contrast
agent.
``(2) The agency center charged with premarket review of
devices shall have primary jurisdiction with respect to the
review of an application, notification, or request described in
paragraph (1). In conducting such review, such agency center
may--
``(A) consult with the agency center charged with the
premarket review of drugs or biological products; and
``(B) review information and data provided to the
Secretary by the sponsor of a contrast agent in an
application submitted under section 505 of this Act or
section 351 of the Public Health Service Act, so long
as the sponsor of such contrast agent has provided to
the sponsor of the applicable medical imaging device
that is the subject of such review a right of reference
and the application is submitted in accordance with
this subsection.
``(3) An application submitted under section 515, a
notification submitted under section 510(k), or a request
submitted under section 513(f)(2), as described in paragraph
(1), with respect to an applicable medical imaging device shall
be subject to the requirements of such respective section. Such
application, notification, or request shall only be subject to
the requirements of this Act applicable to devices.
``(4) For purposes of this subsection and section 505(y)--
``(A) the term `applicable medical imaging device'
means a device intended to be used in conjunction with
a contrast agent (or class of contrast agents) for an
imaging use that is not described in the approved
labeling of such contrast agent (or the approved
labeling of any contrast agent in the same class as
such contrast agent); and
``(B) the term `contrast agent' means a drug that is
approved under section 505 or licensed under section
351 of the Public Health Service Act, is intended for
use in conjunction with an applicable medical imaging
device, and--
``(i) is a diagnostic radiopharmaceutical, as
defined in section 315.2 and 601.31 of title
21, Code of Federal Regulations (or any
successor regulations); or
``(ii) is a diagnostic agent that improves
the visualization of structure or function
within the body by increasing the relative
difference in signal intensity within the
target tissue, structure, or fluid.''.
SEC. 802. APPLICATIONS FOR APPROVAL OF CONTRAST AGENTS INTENDED FOR USE
WITH CERTAIN DIAGNOSTIC MEDICAL IMAGING DEVICES.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) is amended by adding at the end the following:
``(y) Contrast Agents Intended for Use With Applicable Medical
Imaging Devices.--
``(1) The sponsor of a contrast agent for which an
application has been approved under this section may submit a
supplement to the application seeking approval for the use of
the contrast agent for a new indication and conditions of use
following the authorization of a premarket submission for an
applicable medical imaging device for that use with the
contrast agent pursuant to section 520(q)(1).
``(2) In reviewing a supplement submitted under this
subsection, the agency center charged with the premarket review
of drugs may--
``(A) consult with the center charged with the
premarket review of devices; and
``(B) review information and data submitted to the
Secretary by the sponsor of an applicable medical
imaging device pursuant to section 515, 510(k), or
513(f)(2) so long as the sponsor of such applicable
medical imaging device has provided to the sponsor of
the contrast agent a right of reference.
``(3) For purposes of this subsection--
``(A) the term `new indication' means a use of a
contrast agent that is described in the approved
labeling of an applicable medical imaging device
described in section 520(q), but that is not described
in the approved labeling of the contrast agent; and
``(B) the term `applicable medical imaging device'
and `contrast agent' have the meanings given such terms
in section 520(q).''.
TITLE IX--ADDITIONAL PROVISIONS
SEC. 901. TECHNICAL CORRECTIONS.
(a) Section 3075(a) of the 21st Century Cures Act (Public Law 114-
255) is amended--
(1) in the matter preceding paragraph (1), by striking ``as
amended by section 2074'' and inserting ``as amended by section
3102''; and
(2) in paragraph (2), by striking ``section 2074(1)(C)'' and
inserting ``section 3102(1)(C)''.
(b) Section 506G(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 356g(b)(1)(A)) is amended by striking ``identity'' and
inserting ``identify''.
(c) Section 505F(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355g(b)) is amended by striking ``randomized'' and inserting
``traditional''.
(d) Section 505F(d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355g(d)) is amended by striking ``2'' and inserting ``3''.
(e) Effective as of the enactment of the 21st Century Cures Act
(Public Law 114-255)--
(1) section 3051(a) of such Act is amended by striking ``by
inserting after section 515B'' and inserting ``by inserting
after section 515A''; and
(2) section 515C of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e-3), as inserted by such section 3051(a), is
redesignated as section 515B.
(f) Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e-3(f)(2)), as redesignated by subsection (e)(2) of this
section, is amended by striking ``a proposed guidance'' and inserting
``a draft version of that guidance''.
(g) Section 513(b)(5)(D) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360c(b)(5)(D)) is amended by striking ``medical device
submissions'' and inserting ``medical devices that may be specifically
the subject of a review by a classification panel''.
SEC. 902. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE
PARTNERSHIPS.
Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-5(f)) is amended by striking ``2013 through 2017'' and inserting
``2018 through 2022''.
Purpose and Summary
The Food and Drug Administration (FDA) Reauthorization Act
of 2017 enables FDA to continue to collect user fees from
regulated industry to supplement Congressional appropriations.
Specifically, the bill revises and reauthorizes the
Prescription Drug User Fee Act (PDUFA), the Medical Device User
Fee Amendments (MDUFA), the Generic Drug User Fee Amendments
(GDUFA), and the Biosimilars User Fee Act (BsUFA) through 2022.
In addition, the bill makes a number of changes to improve the
regulation of medical products, supports the development of
pediatric drugs and medical devices, and will encourage
increased generic competition.
Background and Need for Legislation
Since 1992, pursuant to PDUFA, Congress has authorized FDA
to collect fees from regulated industry to supplement
Congressional appropriations. Revenues generated from these
fees have been used on specific activities related to the
review and regulation of medical products. FDA also commits to
meeting certain performance goals, such as completing product
reviews within specified timeframes. FDA's ability to collect
such fees must be reauthorized every five years following a
process laid out in statute that involves negotiations between
the agency and regulated industry and recommendations provided
to Congress. The reauthorization process allows for input for
other interested stakeholders, including patient and consumer
groups, and provides opportunity for broader public comment.
Based in large part on the positive impact PDUFA had on
expediting new drug product review times and improving related
regulatory activities at FDA, medical device user fees were
authorized in 2002 and the Medical Device User Fee Amendments
(MDUFA) were reauthorized in 2007 and 2012, along with PDUFA.
Due to growing concerns from a wide range of stakeholders
about the time it was taking FDA to review generic drug
applications (known as ``abbreviated new drug applications'' or
``ANDAs'') and the backlog of such applications pending at the
agency, Congress passed the Generic Drug User Fee Amendments
(GDUFA) in 2012, as part of the Food and Drug Administration
Safety and Innovation Act (FDASIA).
Pursuant to the Biologics Price Competition and Innovation
Act (BCPIA) of 2009, Congress established a new regulatory
authority for FDA to create an abbreviated approval pathway for
biological products demonstrated to be ``highly similar'' to,
or ``interchangeable'' with, a previously licensed biological
product. As part of FDASIA, Congress passed the BsUFA in 2012
to authorize FDA to collect user fees from biosimilar product
manufacturers.
Each of these four user fee programs is due to expire at
the end of this fiscal year and must be reauthorized through
2022, which the FDA Reauthorization Act of 2017 would do.
Throughout conversations and hearings related to the bill,
members brought forward additional policies that would improve
the regulation of certain medical products. A number of these
policies are also included in the bill.
Hearings
On March 2, 2017, the Subcommittee on Health held a hearing
entitled ``Examining FDA's Generic Drug and Biosimilar User Fee
Programs'' and received testimony from the following witnesses:
Janet Woodcock, M.D., Director, Center for
Drug Evaluation and Research, Food and Drug
Administration;
David Gaugh, Senior Vice President of
Sciences and Regulatory Sciences, Association for
Accessible Medicines;
Bruce A. Leicher, Senior Vice President and
General Counsel, Momenta Pharmaceuticals, Inc., Chair,
The Biosimilars Council, a Division of the Association
for Accessible Medicines;
Juliana Reed, Vice President of Government
Affairs, Coherus BioSciences, Immediate Past President,
The Biosimilars Forum;
Kay Holcombe, Senior Vice President of
Science Policy, Biotechnology Industry Organization;
and,
Allan Coukell, Senior Director, Health
Programs, The Pew Charitable Trusts.
On March 20, 2017, the Subcommittee on Health held a
hearing entitled ``Examining FDA's Prescription Drug User Fee
Program'' and received testimony from the following witnesses:
Janet Woodcock, M.D., Director, Center for
Drug Evaluation and Research, Food and Drug
Administration;
Jeff Allen, President and CEO, Friends of
Cancer Research;
Kay Holcombe, Senior Vice President of
Science Policy, Biotechnology Industry Organization;
and,
Anne Pritchett, Vice President of Policy and
Research, Pharmaceutical Research and Manufacturers of
America.
On March 28, 2017, the Subcommittee on Health held a
hearing entitled ``Examining FDA's Medical Device User Fee
Program'' and received testimony from the following witnesses:
Jeffrey Shuren, M.D., J.D., Director, Center
for Devices and Radiological Health, Food and Drug
Administration;
Cynthia Bens, Vice President of Public
Policy, Alliance for Aging Research;
Robert Kieval, Founder and Chief Development
Officer, CVRx;
Patrick Daly, President and CEO, Cohera
Medical; and,
Diane Wurzburger, Executive, Regulatory
Affairs U.S. and Canada, Global Strategic Policy and
Programs, GE Healthcare.
On May 2, 2017, the Subcommittee on Health held a hearing
entitled ``Examining Improvements to the Regulation of Medical
Technologies'' and received testimony from the following
witnesses:
Jeffrey Shuren, M.D., J.D., Director, Center
for Devices and Radiological Health, Food and Drug
Administration;
Thomas Powers, Ph.D., Powers Consulting,
LLC;
Frank Lin, M.D., Ph.D., Associate Professor
of Otolaryngology--Head and Neck Surgery, Geriatric
Medicine, Mental Health, and Epidemiology, Johns
Hopkins University;
Joe Robinson, Senior Vice President, Health
Systems Solutions, Philips North America;
Robert Kerwin, General Counsel,
International Association of Medical Equipment
Remarketers and Servicers; and,
Patricia Shrader, Vice President, Global
Regulatory Affairs, Medtronic.
Committee Consideration
On May 18, 2017, the Subcommittee on Health met in open
markup session and forwarded H.R. 2430 to the full Committee,
as amended, by a voice vote. On June 7, 2017, the full
Committee on Energy and Commerce met in open markup session and
ordered H.R. 2430 reported to the House, as amended, by a vote
of 54 yeas and 0 nays.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto. The
following reflects the record votes taken during the Committee
consideration:
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee held hearings and made
findings that are reflected in this report.
Statement of General Performance Goals and Objectives
The goal of this legislation is to reauthorize four
important user fee programs at FDA and to improve the review
and regulation of medical products.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
2430, would result in no new or increased budget authority,
entitlement authority, or tax expenditures or revenues.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
In compliance with clause 9(e), 9(f), and 9(g) of rule XXI
of the Rules of the House of Representatives, the Committee
finds that H.R. 2430 contains no earmarks, limited tax
benefits, or limited tariff benefits.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974. At the
time this report was filed, the estimate was not available.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII, at the time this
report was filed, the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974 was not available.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Duplication of Federal Programs
No provision of H.R. 2430 establishes or reauthorizes a
program of the Federal Government known to be duplicative of
another Federal program, a program that was included in any
report from the Government Accountability Office to Congress
pursuant to section 21 of Public Law 111-139, or a program
related to a program identified in the most recent Catalog of
Federal Domestic Assistance.
Disclosure of Directed Rule Makings
Pursuant to section 3(i) of H. Res. 5, the following
directed rule makings are contained in H.R. 2430:
1. Section 603 requires FDA to issue a draft and
final guidance document specifying how the agency will
implement the process changes for inspecting medical
device facilities pursuant to this section.
2. Section 604 requires FDA to issue a draft and
final guidance document providing for a process for
resolving issues relating to certifications to foreign
government for medical devices being exported.
3. Section 613 requires FDA, not later than three
years after the date of enactment, to promulgate
proposed regulations to establish a category of over-
the-counter hearing aids. Not later than 180 days after
the date on which the public comment period on the
proposed regulations closes, FDA shall issue final
regulations.
4. Section 613 also requires FDA to update and
finalize a draft guidance document clarifying which
products meet the definition of a medical device and
which products meet the definition of a personal sound
amplification product.
5. Section 701 requires FDA to issue a draft and
final guidance document specifying the actions the
agency will take to expedite the development and review
of certain generic drug applications and, if FDA
determines that it is necessary to amend the
regulations, the agency shall do so not later than two
years after the date of enactment.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
TITLE I--FEES RELATING TO DRUGS
Section 101. Short title; finding
Section 101 establishes a short title--``Prescription Drug
User Fee Amendments of 2017''--and provides that the fees
authorized in the title will go toward human prescription drug
activities as set forth in the commitment letter submitted to
the Congressional Record.
Section 102. Authority to assess and use drug fees
Section 102 reauthorizes FDA's ability to collect user fees
at a higher level, and restructures such fees to reduce
administrative burden and make funding more predictable.
The section also modernizes the fee structure and updates
the base fee amount. Historically, fees were derived one-third
from facility fees, one-third from various application fees,
and one-third from product fees. The new structure is derived
from 20 percent application fees and 80 percent program fees
for approved products. Supplemental application fees and
facility fees are eliminated. In fiscal year (FY) 2018, the
base fee amount will be $878,590,000.
In addition, the section replaces the workload adjustment
with a capacity planning adjuster so that fees more accurately
reflect the workload and existing staff capacity at FDA.
Section 103. Reauthorization; reporting requirements
Section 103 maintains the existing reauthorization process
and reporting requirements. The Secretary of Health and Human
Services (HHS) is required to provide recommendations to
Congress by January 15, 2022, after an extensive process of
public meetings. Performance and financial reports continue to
be due to Congress every year.
Section 104. Sunset dates
Section 104 sunsets the authority to collect fees on
October 1, 2022, and the requirement to submit performance and
financial reports on January 31, 2023.
Section 105. Effective date
Section 105 clarifies that the effective date is October 1,
2017, or date of enactment, whichever is later, and the fee
structure and amount in this Act applies to all human drug
applications received on or after October 1, 2017, regardless
of the date of the enactment of this Act.
Section 106. Savings clause
Section 106 clarifies that submissions made prior to
October 1, 2017, will continue to be reviewed and assessed fees
based on the agreement for FY 2012 to 2017.
TITLE II--FEES RELATING TO DEVICES
Section 201. Short title; findings
Section 201 establishes a short title--``Medical Device
Drug User Fee Amendments of 2017''--and provides that the fees
authorized in the title will go toward medical device
activities as set forth in the commitment letter submitted to
the Congressional Record.
Section 202. Definitions
Section 202 adds the term ``de novo classification
request'' to enable new user fees specifically for review of de
novo medical device classification requests.
Section 203. Authority to assess and use device fees
Section 203 adds authority to collect fees for de novo
classification request.
The section also updates the target base fee amounts for
each year. The FY 2018 base is increased to $183,280,756,
ending at $213,687,660 in FY 2022.
In addition, the section updates the adjustment for
inflation and allows the Secretary of HHS to increase, if
necessary, the fees to meet the base target.
Section 203 also reauthorizes the authority to collect, and
the availability and crediting, of fees.
Section 204. Reauthorization; reporting requirements
Section 204 maintains the existing reauthorization and
reporting requirements. The Secretary of HHS is required to
provide recommendations to Congress by January 15, 2022, after
an extensive process of public meetings. Performance and
financial reports continue to be due to Congress every year.
Section 205. Conformity assessment pilot program
Section 205 establishes a pilot program to provide FDA the
authority to audit and certify laboratories who conduct device
conformance testing to a recognized standard, and also to
withdraw the certification if necessary. FDA is required to
evaluate the use of this scheme in at least five device types,
or device parts that are found in multiple devices. FDA is also
required to obtain public input on the development of the
pilot.
The authority for the pilot project sunsets in 2022.
Section 206. Reauthorization of review
Section 206 reauthorizes and provides flexibility for the
Secretary of HHS to better target which device types are most
appropriate for, third party review.
The section also requires the Secretary of HHS to conduct a
public guidance development process to identify the factors the
Secretary of HHS will use to determine which devices are
eligible for third party review.
Section 207. Electronic format for submissions
FDA currently receives both paper and electronic
submissions. Section 207 requires all submissions to be in
electronic format by October 1, 2021. The Secretary of HHS has
the authority to extend the date as late as April 1, 2023.
Section 208. Savings clause
Section 208 clarifies that submissions made prior to
October 1, 2017, will continue to be reviewed and assessed fees
based on the agreement for FY 2012 to 2017.
Section 209. Effective date
Section 209 clarifies that the effective date is October 1,
2017, or date of enactment, whichever is later, and the fee
structure and amount in this Act applies to all medical device
applications received on or after October 1, 2017, regardless
of the date of the enactment of this Act.
Section 210. Sunset clause
The authority to collect fees sunsets on October 1, 2022,
and the requirement to submit performance and financial reports
on January 31, 2023.
TITLE III--FEES RELATING TO GENERIC DRUGS
Section 301. Short title; finding
Section 301 establishes a short title--``Generic Drug User
Fee Amendments of 2017''--and provides that the fees authorized
in the title will go toward human generic drug activities, as
set forth in the commitment letter submitted to the
Congressional Record.
Section 302. Definitions
The definitions are amended to clarify that submissions by
a State or Federal Government entity for drugs not intended for
sale do not have to pay user fees. A definition for ``contract
manufacturing organization facility'' is also included.
Section 303. Authority to assess and use human generic drug fees
Section 303 updates the fee structure to provide more
predictability for FDA and flexibility for small businesses.
The section removes the fees for prior approval supplements
and establishes a generic drug applicant program fee.
Thirty-three percent of the total user fee revenue will
come from application fees, 20 percent of such revenue will
come from generic drug facility fees, seven percent of such
revenue will come from active pharmaceutical ingredient
facility fees, and 35 percent of such revenue will come from a
new generic drug applicant program fee.
The generic drug applicant program fee is determined by how
many applications the applicant has approved by the FDA:
a manufacturer with 20 or more approved
applications pays the full fee;
a manufacturer with six-19 approved
applications pays 40 percent of the full fee; and
a manufacturer with five or fewer approved
applications pays 10 percent of the full fee.
The base fee amount is updated to $493,600,000 in FY 2018.
Section 304. Reauthorization; reporting requirements
Section 304 maintains the existing reauthorization and
reporting requirements. The Secretary of HHS is required to
provide recommendations to Congress by January 15, 2022, after
an extensive process of public meetings. Performance and
financial reports continue to be due to Congress every year.
Section 305. Sunset dates
The authority to collect fees sunsets on October 1, 2022,
and the requirement to submit performance and financial reports
on January 31, 2023.
Section 306. Effective date
Section 306 clarifies that the effective date is October 1,
2017, or date of enactment, whichever is later, and the fee
structure and amount in this Act applies to all human generic
drug applications received on or after October 1, 2017,
regardless of the date of the enactment of this Act.
Section 307. Savings clause
Section 307 clarifies that submissions made prior to
October 1, 2017, will continue to be reviewed and assessed fees
based on the agreement for FY 2012 to 2017.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Section 401. Short title; finding
Section 401 establishes a short title--``Biosimilar User
Fee Amendments of 2017''--and that the fees authorized in the
title will go toward biosimilar activities as set forth in the
commitment letter submitted to the Congressional Record.
Section 402. Definitions
Technical updates are made to the definitions of
``adjustment factor'' and ``biosimilar biological product to
provide clarity.''
Section 403. Authority to assess and use biosimilar fees
Section 403 establishes an independent fee structure for
biosimilars for the first time based on the following types of
fees:
Initial Biosimilar Development Fee for the
first year once a sponsor begins clinical trials for a
new biosimilar;
Annual Biosimilar Development Fee for
subsequent years a sponsor is developing a new
biosimilar;
Biosimilar Program Fee for sponsors of
approved biosimilars; and
Application Fee for new biosimilar
applications.
The section eliminates supplement and establishment fees
and allows the Secretary of HHS to determine the appropriate
percentage that will come from each of the fees, and each fee
amount annually. The base fee amount is updated to $45,000,000.
Section 404. Reauthorization; reporting requirements
Section 404 maintains the existing reauthorization and
reporting requirements. The Secretary of HHS is required to
provide recommendations to Congress by January 15, 2022, after
an extensive process of public meetings. Performance and
financial reports continue to be due to Congress every year.
Section 405. Sunset dates
The authority to collect fees sunsets on October 1, 2022,
and the requirement to submit performance and financial reports
on January 31, 2023.
Section 406. Effective date
Section 406 clarifies that the effective date is October 1,
2017, or date of enactment, whichever is later, and the fee
structure and amount in this Act applies to all biosimilar
applications received on or after October 1, 2017, regardless
of the date of the enactment of this Act.
Section 407. Savings clause
Section 407 clarifies that submissions made prior to
October 1, 2017, will continue to be reviewed and assessed fees
based on the agreement for FY 2012 to 2017.
TITLE V--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS
Section 501. Reauthorization of provision relating to exclusivity of
certain drugs containing single enantiomers
Section 501 reauthorizes section 505(u), which provides the
Secretary of HHS the authority to grant exclusivity for drugs
containing single enantiomers, until 2022.
Section 502. Reauthorization of orphan grants program
Section 503 reauthorizes the authority of FDA to issue
grants for orphan drug development until 2022.
Section 503. Reauthorization of pediatric study of drugs
Section 503 reauthorizes funding for National Institutes of
Health to conduct pediatric trials not being conducted by drug
sponsors.
Section 504. Protecting and strengthening the drug supply chain
Section 504 harmonizes the penalties for illegally
diverting drugs into the U.S. that were manufactured abroad and
intended for foreign markets with the penalties for diverting
drugs that were initially manufactured in the U.S.
The section raises the penalties for knowingly making,
selling or dispensing, or holding for sale or dispensing, a
counterfeit drug to conform with the penalties for illegally
diverting drugs.
Section 505. Sense of Congress on lowering the cost of prescription
drugs
Section 505 expresses a Sense of Congress that the
Secretary of HHS should commit to engaging with Congress on
administrative actions and legislative changes to lower the
cost of prescription drugs.
TITLE VI--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS
Section 601. Risk-based inspections for devices
Section 601 requires FDA to inspect medical device
establishments using a risk-based inspection schedule based on
a number of considerations.
Section 602. Recognition of foreign government inspections
Section 602 applies changes made in section 603 to section
809 of the FDCA, recognizing foreign government inspections.
Section 603. Improvements to inspections process for device
establishments
Section 603 establishes standards to improve predictability
for scheduled (not for-cause) inspections for medical device
facilities.
Section 604. Certificates to foreign governments for devices
Section 604 clarifies the process for issuance of foreign
export certificates for medical devices. The section also
establishes a pathway by which manufacturers denied a
certificate can present information and work with FDA to
correct any outstanding issue.
Section 605. Facilitating international harmonization
Section 605 allows FDA to recognize auditors used by
foreign governments to improve international harmonization of
inspection standards and increase FDA access to audit data.
Section 606. Reauthorization of inspection program
Section 606 reauthorizes the authority of FDA to conduct
inspections via accredited organizations.
Section 611. Reauthorization of pediatric humanitarian device
exceptions
Section 611 reauthorizes rules regarding the development of
medical devices for rare pediatric conditions until 2022.
Section 612. Reauthorization of pediatric device consortia
Section 612 reauthorizes the authority of FDA to issue
grants to consortia working to develop medical devices for
pediatric population at current law authorization levels until
2022.
Section 613. Regulation of over-the-counter hearing aids
Section 613 requires FDA to promulgate regulations to
establish a category of over-the-counter (OTC) hearing aids. In
doing so, FDA should consult with relevant stakeholders,
including hearing aid manufacturers, licensed hearing
professionals, patients, and others, during the rulemaking
process.
Section 614. Report on ensuring quality, safety, and continued
effectiveness of devices that have been serviced
Section 614 requires FDA to issue a report on how the
agency intends to ensure the quality, safety, and effectiveness
of medical devices that have been serviced, as well as whether
FDA's current authority is sufficient is to oversee and
regulate servicing or whether additional authority is
necessary.
Section 615. Device pilot projects to generate reliable and timely
safety and active surveillance data
Section 615 creates a new voluntary pilot program for
medical device manufacturers who wish to meet FDA reporting or
post-market study requirements using active surveillance.
Requires FDA to report safety data from the pilot consistent
with current reporting.
Section 616. Risk-based classification of accessories
Section 616 clarifies a process by which FDA classifies
medical device accessories based on the intended use of the
accessory.
TITLE VII--GENERIC DRUG ACCESS AND COMPETITION
Section 701. Competitive Generic Therapies
Section 701 requires FDA to expedite the review and
development of generic drugs if there is not more than one
approved version of the drug actively being marketed.
Section 702. Enhancing regulatory transparency to enhance generic
competition
Section 702 improves communication between FDA and generic
drug application sponsors about the categorical status of their
applications.
Section 703. Incentivizing competitive generic therapy development
Section 703 provides a period of 180-day market exclusivity
to certain generic drug manufacturers that enter the market
where there is currently no blocking patents or exclusivities,
incentivizing generic drug manufacturers to compete with off-
patent drugs.
Section 704. Tropical disease product application
Section 704 clarifies the qualifying criteria for companies
receiving a neglected tropical diseases priority review voucher
(PRV) to ensure the PRV is awarded to sponsors that conduct new
clinical investigations necessary for FDA approval.
Section 705. GAO study of issues regarding first cycle approvals of
generic medicines
Section 705 directs the Government Accountability Office
(GAO) to issue a report on the rate of generic drug
applications that are approved on the first review cycle and
related issues.
TITLE VIII--FOSTERING INNOVATION IN MEDICAL IMAGING
Section 801. Approval of applications for certain diagnostic medical
imaging devices
Section 801 allows the FDA to approve a medical imaging
device with the use of a contrast agent as long as the contrast
agent is used at the same dose, in the same patient population,
with the same type of imaging technology, and does not pose any
additional safety risk.
Section 802. Applications for approval of contrast agents intended for
use with certain diagnostic medical imaging devices
Section 802 clarifies that a contrast agent for which an
application has been approved may be approved for a new
indication or condition of use following the authorization of a
premarket submission for an applicable medical imaging device
for that use.
TITLE IX--ADDITIONAL PROVISIONS
Section 901. Technical corrections
Section 901 makes technical changes to provisions in 21st
Century Cures.
Section 902. Reauthorization of the critical path public-private
partnerships
Section 902 reauthorizes the critical path public-private
partnership for an additional five years at current law
authorization levels.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, and existing law in which no
change is proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER III--PROHIBITED ACTS AND PENALTIES
* * * * * * *
penalties
Sec. 303. (a)(1) Any person who violates a provision of
section 301 shall be imprisoned for not more than one year or
fined not more than $1,000, or both.
(2) Notwithstanding the provisions of paragraph (1) of this
section, if any person commits such a violation after a
conviction of him under this section has become final, or
commits such a violation with the intent to defraud or mislead,
such person shall be imprisoned for not more than three years
or fined not more than $10,000 or both.
(b)(1) Notwithstanding subsection (a), any person who
violates section 301(t) by--
(A) knowingly importing a drug in violation of
section 801(d)(1),
(B) knowingly selling, purchasing, or trading a drug
or drug sample or knowingly offering to sell, purchase,
or trade a drug or drug sample, in violation of section
503(c)(1),
(C) knowingly selling, purchasing, or trading a
coupon, knowingly offering to sell, purchase, or trade
such a coupon, or knowingly counterfeiting such a
coupon, in violation of section 503(c)(2), or
(D) knowingly distributing drugs in violation of
section 503(e)(1),
shall be imprisoned for not more than 10 years or fined not
more than $250,000, or both.
(2) Any manufacturer or distributor who distributes drug
samples by means other than the mail or common carrier whose
representative, during the course of the representative's
employment or association with that manufacturer or
distributor, violated section 301(t) because of a violation of
section 503(c)(1) or violated any State law prohibiting the
sale, purchase, or trade of a drug sample subject to section
503(b) or the offer to sell, purchase, or trade such a drug
sample shall, upon conviction of the representative for such
violation, be subject to the following civil penalties:
(A) A civil penalty of not more than $50,000 for each
of the first two such violations resulting in a
conviction of any representative of the manufacturer or
distributor in any 10-year period.
(B) A civil penalty of not more than $1,000,000 for
each violation resulting in a conviction of any
representative after the second conviction in any 10-
year period.
For the purposes of this paragraph, multiple convictions of one
or more persons arising out of the same event or transaction,
or a related series of events or transactions, shall be
considered as one violation.
(3) Any manufacturer or distributor who violates section
301(t) because of a failure to make a report required by
section 503(d)(3)(E) shall be subject to a civil penalty of not
more than $100,000.
(4)(A) If a manufacturer or distributor or any representative
of such manufacturer or distributor provides information
leading to the institution of a criminal proceeding against,
and conviction of, any representative of that manufacturer or
distributor for a violation of section 301(t) because of a
sale, purchase, or trade or offer to purchase, sell, or trade a
drug sample in violation of section 503(c)(1) or for a
violation of State law prohibiting the sale, purchase, or trade
or offer to sell, purchase, or trade a drug sample, the
conviction of such representative shall not be considered as a
violation for purposes of paragraph (2).
(B) If, in an action brought under paragraph (2) against a
manufacturer or distributor relating to the conviction of a
representative of such manufacturer or distributor for the
sale, purchase, or trade of a drug or the offer to sell,
purchase, or trade a drug, it is shown, by clear and convincing
evidence--
(i) that the manufacturer or distributor conducted,
before the institution of a criminal proceeding against
such representative for the violation which resulted in
such conviction, an investigation of events or
transactions which would have led to the reporting of
information leading to the institution of a criminal
proceeding against, and conviction of, such
representative for such purchase, sale, or trade or
offer to purchase, sell, or trade, or
(ii) that, except in the case of the conviction of a
representative employed in a supervisory function,
despite diligent implementation by the manufacturer or
distributor of an independent audit and security system
designed to detect such a violation, the manufacturer
or distributor could not reasonably have been expected
to have detected such violation,
the conviction of such representative shall not be considered
as a conviction for purposes of paragraph (2).
(5) If a person provides information leading to the
institution of a criminal proceeding against, and conviction
of, a person for a violation of section 301(t) because of the
sale, purchase, or trade of a drug sample or the offer to sell,
purchase, or trade a drug sample in violation of section
503(c)(1), such person shall be entitled to one-half of the
criminal fine imposed and collected for such violation but not
more than $125,000.
(6) Notwithstanding subsection (a), any person who is a
manufacturer or importer of a prescription drug under section
804(b) and knowingly fails to comply with a requirement of
section 804(e) that is applicable to such manufacturer or
importer, respectively, shall be imprisoned for not more than
10 years or fined not more than $250,000, or both.
(7) Notwithstanding subsection (a)(2), any person that
knowingly and intentionally adulterates a drug such that the
drug is adulterated under subsection (a)(1), (b), (c), or (d)
of section 501 and has a reasonable probability of causing
serious adverse health consequences or death to humans or
animals shall be imprisoned for not more than 20 years or fined
not more than $1,000,000, or both.
(8) Notwithstanding subsection (a), any person who violates
section 301(i)(3) by knowingly making, selling or dispensing,
or holding for sale or dispensing, a counterfeit drug shall be
imprisoned for not more than 10 years or fined in accordance
with title 18, United States Code, or both.
(c) No person shall be subject to the penalties of subsection
(a)(1) of this section, (1) for having received in interstate
commerce any article and delivered it or proffered delivery of
it, if such delivery or proffer was made in good faith, unless
he refuses to furnish on request of an officer or employee duly
designated by the Secretary the name and address of the person
from whom he purchased or received such article and copies of
all documents, if any there be, pertaining to the delivery of
the article to him; or (2) for having violated section 301(a)
or (d), if he establishes a guaranty or undertaking signed by,
and containing the name and address of, the person residing in
the United States from whom he received in good faith the
article, to the effect, in case of an alleged violation of
section 301(a), that such article is not adulterated or
misbranded, within the meaning of this Act, designating this
Act, or to the effect, in case of an alleged violation of
section 301(d), that such article is not an article which may
not, under the provisions of section 404 or 505, be introduced
into interstate commerce; or (3) for having violated section
301(a), where the violation exists because the article is
adulterated by reason of containing a color additive not from a
batch certified in accordance with regulations promulgated by
the Secretary under this Act, if such person establishes a
guaranty or undertaking signed by, and containing the name and
address of, the manufacturer of the color additive, to the
effect that such color additive was from a batch certified in
accordance with the applicable regulations promulgated by the
Secretary under this Act; or (4) for having violated section
301 (b), (c), or (k) by failure to comply with section 502(f)
in respect to an article received in interstate commerce to
which neither section 503(a) nor section 503(b)(1) is
applicable, if the delivery or proffered delivery was made in
good faith and the labeling at the time thereof contained the
same directions for use and warning statements as were
contained in the labeling at the time of such receipt of such
article; or (5) for having violated section 301(i)(2) if such
person acted in good faith and had no reason to believe that
use of the punch, die, plate, stone, or other thing involved
would result in a drug being a counterfeit drug, or for having
violated section 301(i)(3) if the person doing the act or
causing it to be done acted in good faith and had no reason to
believe that the drug was a counterfeit drug.
(d) No person shall be subject to the penalties of subsection
(a)(1) of this section for a violation of section 301 involving
misbranded food if the violation exists solely because the food
is misbranded under section 403(a)(2) because of its
advertising.
(e)(1) Except as provided in paragraph (2), whoever knowingly
distributes, or possesses with intent to distribute, human
growth hormone for any use in humans other than the treatment
of a disease or other recognized medical condition, where such
use has been authorized by the Secretary of Health and Human
Services under section 505 and pursuant to the order of a
physician, is guilty of an offense punishable by not more than
5 years in prison, such fines as are authorized by title 18,
United States Code, or both.
(2) Whoever commits any offense set forth in paragraph (1)
and such offense involves an individual under 18 years of age
is punishable by not more than 10 years imprisonment, such
fines as are authorized by title 18, United States Code, or
both.
(3) Any conviction for a violation of paragraphs (1) and (2)
of this subsection shall be considered a felony violation of
the Controlled Substances Act for the purposes of forfeiture
under section 413 of such Act.
(4) As used in this subsection the term ``human growth
hormone'' means somatrem, somatropin, or an analogue of either
of them.
(5) The Drug Enforcement Administration is authorized to
investigate offenses punishable by this subsection.
(f)(1)(A) Except as provided in subparagraph (B), any person
who violates a requirement of this Act which relates to devices
shall be liable to the United States for a civil penalty in an
amount not to exceed $15,000 for each such violation, and not
to exceed $1,000,000 for all such violations adjudicated in a
single proceeding. For purposes of the preceding sentence, a
person accredited under paragraph (2) of section 704(g) who is
substantially not in compliance with the standards of
accreditation under such section, or who poses a threat to
public health or fails to act in a manner that is consistent
with the purposes of such section, shall be considered to have
violated a requirement of this Act that relates to devices.
(B) Subparagraph (A) shall not apply--
(i) to any person who violates the requirements of
section 519(a) or 520(f) unless such violation
constitutes (I) a significant or knowing departure from
such requirements, or (II) a risk to public health,
(ii) to any person who commits minor violations of
section 519(e) or 519(g) (only with respect to
correction reports) if such person demonstrates
substantial compliance with such section, or
(iii) to violations of section 501(a)(2)(A) which
involve one or more devices which are not defective.
(2)(A) Any person who introduces into interstate commerce or
delivers for introduction into interstate commerce an article
of food that is adulterated within the meaning of section
402(a)(2)(B) or any person who does not comply with a recall
order under section 423 shall be subject to a civil money
penalty of not more than $50,000 in the case of an individual
and $250,000 in the case of any other person for such
introduction or delivery, not to exceed $500,000 for all such
violations adjudicated in a single proceeding.
(B) This paragraph shall not apply to any person who grew the
article of food that is adulterated. If the Secretary assesses
a civil penalty against any person under this paragraph, the
Secretary may not use the criminal authorities under this
section to sanction such person for the introduction or
delivery for introduction into interstate commerce of the
article of food that is adulterated. If the Secretary assesses
a civil penalty against any person under this paragraph, the
Secretary may not use the seizure authorities of section 304 or
the injunction authorities of section 302 with respect to the
article of food that is adulterated.
(C) In a hearing to assess a civil penalty under this
paragraph, the presiding officer shall have the same authority
with regard to compelling testimony or production of documents
as a presiding officer has under section 408(g)(2)(B). The
third sentence of paragraph (5)(A) shall not apply to any
investigation under this paragraph.
(3)(A) Any person who violates section 301(jj) shall be
subject to a civil monetary penalty of not more than $10,000
for all violations adjudicated in a single proceeding.
(B) If a violation of section 301(jj) is not corrected within
the 30-day period following notification under section
402(j)(5)(C)(ii), the person shall, in addition to any penalty
under subparagraph (A), be subject to a civil monetary penalty
of not more than $10,000 for each day of the violation after
such period until the violation is corrected.
(4)(A) Any responsible person (as such term is used in
section 505-1) that violates a requirement of section 505(o),
505(p), or 505-1 shall be subject to a civil monetary penalty
of--
(i) not more than $250,000 per violation, and not to
exceed $1,000,000 for all such violations adjudicated
in a single proceeding; or
(ii) in the case of a violation that continues after
the Secretary provides written notice to the
responsible person, the responsible person shall be
subject to a civil monetary penalty of $250,000 for the
first 30-day period (or any portion thereof) that the
responsible person continues to be in violation, and
such amount shall double for every 30-day period
thereafter that the violation continues, not to exceed
$1,000,000 for any 30-day period, and not to exceed
$10,000,000 for all such violations adjudicated in a
single proceeding.
(B) In determining the amount of a civil penalty under
subparagraph (A)(ii), the Secretary shall take into
consideration whether the responsible person is making efforts
toward correcting the violation of the requirement of section
505(o), 505(p), or 505-1 for which the responsible person is
subject to such civil penalty.
(5)(A) A civil penalty under paragraph (1), (2), (3), (4), or
(9) shall be assessed, or a no-tobacco-sale order may be
imposed, by the Secretary by an order made on the record after
opportunity for a hearing provided in accordance with this
subparagraph and section 554 of title 5, United States Code.
Before issuing such an order, the Secretary shall give written
notice to the person to be assessed a civil penalty, or upon
whom a no-tobacco-sale order is to be imposed, under such order
of the Secretary's proposal to issue such order and provide
such person an opportunity for a hearing on the order. In the
course of any investigation, the Secretary may issue subpoenas
requiring the attendance and testimony of witnesses and the
production of evidence that relates to the matter under
investigation.
(B) In determining the amount of a civil penalty, or the
period to be covered by a no-tobacco-sale order, the Secretary
shall take into account the nature, circumstances, extent, and
gravity of the violation or violations and, with respect to the
violator, ability to pay, effect on ability to continue to do
business, any history of prior such violations, the degree of
culpability, and such other matters as justice may require. A
no-tobacco-sale order permanently prohibiting an individual
retail outlet from selling tobacco products shall include
provisions that allow the outlet, after a specified period of
time, to request that the Secretary compromise, modify, or
terminate the order.
(C) The Secretary may compromise, modify, or remit, with or
without conditions, any civil penalty which may be assessed
under paragraph (1), (2), (3), (4), or (9). The amount of such
penalty, when finally determined, or the amount agreed upon in
compromise, may be deducted from any sums owing by the United
States to the person charged.
(D) The Secretary may compromise, modify, or terminate, with
or without conditions, any no-tobacco-sale order.
(6) Any person who requested, in accordance with paragraph
(5)(A), a hearing respecting the assessment of a civil penalty
or the imposition of a no-tobacco-sale order and who is
aggrieved by an order assessing a civil penalty or the
imposition of a no-tobacco-sale order may file a petition for
judicial review of such order with the United States Court of
Appeals for the District of Columbia Circuit or for any other
circuit in which such person resides or transacts business.
Such a petition may only be filed within the 60-day period
beginning on the date the order making such assessment was
issued, or on which the no-tobacco-sale order was imposed, as
the case may be.
(7) If any person fails to pay an assessment of a civil
penalty--
(A) after the order making the assessment becomes
final, and if such person does not file a petition for
judicial review of the order in accordance with
paragraph (6), or
(B) after a court in an action brought under
paragraph (6) has entered a final judgment in favor of
the Secretary,
the Attorney General shall recover the amount assessed (plus
interest at currently prevailing rates from the date of the
expiration of the 60-day period referred to in paragraph (6) or
the date of such final judgment, as the case may be) in an
action brought in any appropriate district court of the United
States. In such an action, the validity, amount, and
appropriateness of such penalty shall not be subject to review.
(8) If the Secretary finds that a person has committed
repeated violations of restrictions promulgated under section
906(d) at a particular retail outlet then the Secretary may
impose a no-tobacco-sale order on that person prohibiting the
sale of tobacco products in that outlet. A no-tobacco-sale
order may be imposed with a civil penalty under paragraph (1).
Prior to the entry of a no-sale order under this paragraph, a
person shall be entitled to a hearing pursuant to the
procedures established through regulations of the Food and Drug
Administration for assessing civil money penalties, including
at a retailer's request a hearing by telephone, or at the
nearest regional or field office of the Food and Drug
Administration, or at a Federal, State, or county facility
within 100 miles from the location of the retail outlet, if
such a facility is available.
(9) Civil Monetary Penalties for Violation of Tobacco Product
Requirements.--
(A) In general.--Subject to subparagraph (B), any
person who violates a requirement of this Act which
relates to tobacco products shall be liable to the
United States for a civil penalty in an amount not to
exceed $15,000 for each such violation, and not to
exceed $1,000,000 for all such violations adjudicated
in a single proceeding.
(B) Enhanced penalties.--
(i) Any person who intentionally violates a
requirement of section 902(5), 902(6), 904,
908(c), or 911(a), shall be subject to a civil
monetary penalty of--
(I) not to exceed $250,000 per
violation, and not to exceed $1,000,000
for all such violations adjudicated in
a single proceeding; or
(II) in the case of a violation that
continues after the Secretary provides
written notice to such person, $250,000
for the first 30-day period (or any
portion thereof) that the person
continues to be in violation, and such
amount shall double for every 30-day
period thereafter that the violation
continues, not to exceed $1,000,000 for
any 30-day period, and not to exceed
$10,000,000 for all such violations
adjudicated in a single proceeding.
(ii) Any person who violates a requirement of
section 911(g)(2)(C)(ii) or 911(i)(1), shall be
subject to a civil monetary penalty of--
(I) not to exceed $250,000 per
violation, and not to exceed $1,000,000
for all such violations adjudicated in
a single proceeding; or
(II) in the case of a violation that
continues after the Secretary provides
written notice to such person, $250,000
for the first 30-day period (or any
portion thereof) that the person
continues to be in violation, and such
amount shall double for every 30-day
period thereafter that the violation
continues, not to exceed $1,000,000 for
any 30-day period, and not to exceed
$10,000,000 for all such violations
adjudicated in a single proceeding.
(iii) In determining the amount of a civil
penalty under clause (i)(II) or (ii)(II), the
Secretary shall take into consideration whether
the person is making efforts toward correcting
the violation of the requirements of the
section for which such person is subject to
such civil penalty.
(g)(1) With respect to a person who is a holder of an
approved application under section 505 for a drug subject to
section 503(b) or under section 351 of the Public Health
Service Act, any such person who disseminates or causes another
party to disseminate a direct-to-consumer advertisement that is
false or misleading shall be liable to the United States for a
civil penalty in an amount not to exceed $250,000 for the first
such violation in any 3-year period, and not to exceed $500,000
for each subsequent violation in any 3-year period. No other
civil monetary penalties in this Act (including the civil
penalty in section 303(f)(4)) shall apply to a violation
regarding direct-to-consumer advertising. For purposes of this
paragraph: (A) Repeated dissemination of the same or similar
advertisement prior to the receipt of the written notice
referred to in paragraph (2) for such advertisements shall be
considered one violation. (B) On and after the date of the
receipt of such a notice, all violations under this paragraph
occurring in a single day shall be considered one violation.
With respect to advertisements that appear in magazines or
other publications that are published less frequently than
daily, each issue date (whether weekly or monthly) shall be
treated as a single day for the purpose of calculating the
number of violations under this paragraph.
(2) A civil penalty under paragraph (1) shall be assessed by
the Secretary by an order made on the record after providing
written notice to the person to be assessed a civil penalty and
an opportunity for a hearing in accordance with this paragraph
and section 554 of title 5, United States Code. If upon receipt
of the written notice, the person to be assessed a civil
penalty objects and requests a hearing, then in the course of
any investigation related to such hearing, the Secretary may
issue subpoenas requiring the attendance and testimony of
witnesses and the production of evidence that relates to the
matter under investigation, including information pertaining to
the factors described in paragraph (3).
(3) The Secretary, in determining the amount of the civil
penalty under paragraph (1), shall take into account the
nature, circumstances, extent, and gravity of the violation or
violations, including the following factors:
(A) Whether the person submitted the advertisement or
a similar advertisement for review under section 736A.
(B) Whether the person submitted the advertisement
for review if required under section 503B.
(C) Whether, after submission of the advertisement as
described in subparagraph (A) or (B), the person
disseminated or caused another party to disseminate the
advertisement before the end of the 45-day comment
period.
(D) Whether the person incorporated any comments made
by the Secretary with regard to the advertisement into
the advertisement prior to its dissemination.
(E) Whether the person ceased distribution of the
advertisement upon receipt of the written notice
referred to in paragraph (2) for such advertisement.
(F) Whether the person had the advertisement reviewed
by qualified medical, regulatory, and legal reviewers
prior to its dissemination.
(G) Whether the violations were material.
(H) Whether the person who created the advertisement
or caused the advertisement to be created acted in good
faith.
(I) Whether the person who created the advertisement
or caused the advertisement to be created has been
assessed a civil penalty under this provision within
the previous 1-year period.
(J) The scope and extent of any voluntary, subsequent
remedial action by the person.
(K) Such other matters, as justice may require.
(4)(A) Subject to subparagraph (B), no person shall be
required to pay a civil penalty under paragraph (1) if the
person submitted the advertisement to the Secretary and
disseminated or caused another party to disseminate such
advertisement after incorporating each comment received from
the Secretary.
(B) The Secretary may retract or modify any prior comments
the Secretary has provided to an advertisement submitted to the
Secretary based on new information or changed circumstances, so
long as the Secretary provides written notice to the person of
the new views of the Secretary on the advertisement and
provides a reasonable time for modification or correction of
the advertisement prior to seeking any civil penalty under
paragraph (1).
(5) The Secretary may compromise, modify, or remit, with or
without conditions, any civil penalty which may be assessed
under paragraph (1). The amount of such penalty, when finally
determined, or the amount charged upon in compromise, may be
deducted from any sums owed by the United States to the person
charged.
(6) Any person who requested, in accordance with paragraph
(2), a hearing with respect to the assessment of a civil
penalty and who is aggrieved by an order assessing a civil
penalty, may file a petition for de novo judicial review of
such order with the United States Court of Appeals for the
District of Columbia Circuit or for any other circuit in which
such person resides or transacts business. Such a petition may
only be filed within the 60-day period beginning on the date
the order making such assessments was issued.
(7) If any person fails to pay an assessment of a civil
penalty under paragraph (1)--
(A) after the order making the assessment becomes
final, and if such person does not file a petition for
judicial review of the order in accordance with
paragraph (6), or
(B) after a court in an action brought under
paragraph (6) has entered a final judgment in favor of
the Secretary,
the Attorney General of the United States shall recover the
amount assessed (plus interest at currently prevailing rates
from the date of the expiration of the 60-day period referred
to in paragraph (6) or the date of such final judgment, as the
case may be) in an action brought in any appropriate district
court of the United States. In such an action, the validity,
amount, and appropriateness of such penalty shall not be
subject to review.
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
* * * * * * *
new drugs
Sec. 505. (a) No person shall introduce or deliver for
introduction into interstate commerce any new drug, unless an
approval of an application filed pursuant to subsection (b) or
(j) is effective with respect to such drug.
(b)(1) Any person may file with the Secretary an application
with respect to any drug subject to the provisions of
subsection (a). Such persons shall submit to the Secretary as a
part of the application (A) full reports of investigations
which have been made to show whether or not such drug is safe
for use and whether such drug is effective in use; (B) a full
list of the articles used as components of such drug; (C) a
full statement of the composition of such drug; (D) a full
description of the methods used in, and the facilities and
controls used for, the manufacture, processing, and packing of
such drug; (E) such samples of such drug and of the articles
used as components thereof as the Secretary may require; (F)
specimens of the labeling proposed to be used for such drug,
and (G) any assessments required under section 505B. The
applicant shall file with the application the patent number and
the expiration date of any patent which claims the drug for
which the applicant submitted the application or which claims a
method of using such drug and with respect to which a claim of
patent infringement could reasonably be asserted if a person
not licensed by the owner engaged in the manufacture use, or
sale of the drug. If a application is filed under this
subsection for a drug and a patent which claims such drug or a
method of using such drug is issued after the filing date but
before approval of the application, the applicant shall amend
the application to include the information required by the
preceding sentence. Upon approval of the application, the
Secretary shall publish information submitted under the two
preceding sentences. The Secretary shall, in consultation with
the Director of the National Institutes of Health and with
representatives of the drug manufacturing industry, review and
develop guidance, as appropriate, on the inclusion of women and
minorities in clinical trials required by clause (A).
(2) An application submitted under paragraph (1) for a drug
for which the investigations described in clause (A) of such
paragraph and relied upon by the applicant for approval of the
application were not conducted by or for the applicant and for
which the applicant has not obtained a right of reference or
use from the person by or for whom the investigations were
conducted shall also include--
(A) a certification, in the opinion of the applicant
and to the best of his knowledge, with respect to each
patent which claims the drug for which such
investigations were conducted or which claims a use for
such drug for which the applicant is seeking approval
under this subsection and for which information is
required to be filed under paragraph (1) or subsection
(c)--
(i) that such patent information has not been
filed,
(ii) that such patent has expired,
(iii) of the date on which such patent will
expire, or
(iv) that such patent is invalid or will not
be infringed by the manufacture, use, or sale
of the new drug for which the application is
submitted; and
(B) if with respect to the drug for which
investigations described in paragraph (1)(A) were
conducted information was filed under paragraph (1) or
subsection (c) for a method of use patent which does
not claim a use for which the applicant is seeking
approval under this subsection, a statement that the
method of use patent does not claim such a use.
(3) Notice of opinion that patent is invalid or will not be
infringed.--
(A) Agreement to give notice.--An applicant that
makes a certification described in paragraph (2)(A)(iv)
shall include in the application a statement that the
applicant will give notice as required by this
paragraph.
(B) Timing of notice.--An applicant that makes a
certification described in paragraph (2)(A)(iv) shall
give notice as required under this paragraph--
(i) if the certification is in the
application, not later than 20 days after the
date of the postmark on the notice with which
the Secretary informs the applicant that the
application has been filed; or
(ii) if the certification is in an amendment
or supplement to the application, at the time
at which the applicant submits the amendment or
supplement, regardless of whether the applicant
has already given notice with respect to
another such certification contained in the
application or in an amendment or supplement to
the application.
(C) Recipients of notice.--An applicant required
under this paragraph to give notice shall give notice
to--
(i) each owner of the patent that is the
subject of the certification (or a
representative of the owner designated to
receive such a notice); and
(ii) the holder of the approved application
under this subsection for the drug that is
claimed by the patent or a use of which is
claimed by the patent (or a representative of
the holder designated to receive such a
notice).
(D) Contents of notice.--A notice required under this
paragraph shall--
(i) state that an application that contains
data from bioavailability or bioequivalence
studies has been submitted under this
subsection for the drug with respect to which
the certification is made to obtain approval to
engage in the commercial manufacture, use, or
sale of the drug before the expiration of the
patent referred to in the certification; and
(ii) include a detailed statement of the
factual and legal basis of the opinion of the
applicant that the patent is invalid or will
not be infringed.
(4)(A) An applicant may not amend or supplement an
application referred to in paragraph (2) to seek approval of a
drug that is a different drug than the drug identified in the
application as submitted to the Secretary.
(B) With respect to the drug for which such an application is
submitted, nothing in this subsection or subsection (c)(3)
prohibits an applicant from amending or supplementing the
application to seek approval of a different strength.
(5)(A) The Secretary shall issue guidance for the individuals
who review applications submitted under paragraph (1) or under
section 351 of the Public Health Service Act, which shall
relate to promptness in conducting the review, technical
excellence, lack of bias and conflict of interest, and
knowledge of regulatory and scientific standards, and which
shall apply equally to all individuals who review such
applications.
(B) The Secretary shall meet with a sponsor of an
investigation or an applicant for approval for a drug under
this subsection or section 351 of the Public Health Service Act
if the sponsor or applicant makes a reasonable written request
for a meeting for the purpose of reaching agreement on the
design and size--
(i)(I) of clinical trials intended to form the
primary basis of an effectiveness claim; or
(II) in the case where human efficacy studies are not
ethical or feasible, of animal and any associated
clinical trials which, in combination, are intended to
form the primary basis of an effectiveness claim; or
(ii) with respect to an application for approval of a
biological product under section 351(k) of the Public
Health Service Act, of any necessary clinical study or
studies.
The sponsor or applicant shall provide information necessary
for discussion and agreement on the design and size of the
clinical trials. Minutes of any such meeting shall be prepared
by the Secretary and made available to the sponsor or applicant
upon request.
(C) Any agreement regarding the parameters of the design and
size of clinical trials of a new drug under this paragraph that
is reached between the Secretary and a sponsor or applicant
shall be reduced to writing and made part of the administrative
record by the Secretary. Such agreement shall not be changed
after the testing begins, except--
(i) with the written agreement of the sponsor or
applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing
division, that a substantial scientific issue essential
to determining the safety or effectiveness of the drug
has been identified after the testing has begun.
(D) A decision under subparagraph (C)(ii) by the director
shall be in writing and the Secretary shall provide to the
sponsor or applicant an opportunity for a meeting at which the
director and the sponsor or applicant will be present and at
which the director will document the scientific issue involved.
(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by,
the field or compliance division personnel unless such field or
compliance division personnel demonstrate to the reviewing
division why such decision should be modified.
(F) No action by the reviewing division may be delayed
because of the unavailability of information from or action by
field personnel unless the reviewing division determines that a
delay is necessary to assure the marketing of a safe and
effective drug.
(G) For purposes of this paragraph, the reviewing division is
the division responsible for the review of an application for
approval of a drug under this subsection or section 351 of the
Public Health Service Act (including all scientific and medical
matters, chemistry, manufacturing, and controls).
(6) An application submitted under this subsection
shall be accompanied by the certification required
under section 402(j)(5)(B) of the Public Health Service
Act. Such certification shall not be considered an
element of such application.
(c)(1) Within one hundred and eighty days after the filing of
an application under subsection (b), or such additional period
as may be agreed upon by the Secretary and the applicant, the
Secretary shall either--
(A) approve the application if he then finds that
none of the grounds for denying approval specified in
subsection (d) applies, or
(B) give the applicant notice of an opportunity for a
hearing before the Secretary under subsection (d) on
the question whether such application is approvable. If
the applicant elects to accept the opportunity for
hearing by written request within thirty days after
such notice, such hearing shall commence not more than
ninety days after the expiration of such thirty days
unless the Secretary and the applicant otherwise agree.
Any such hearing shall thereafter be conducted on an
expedited basis and the Secretary's order thereon shall
be issued within ninety days after the date fixed by
the Secretary for filing final briefs.
(2) If the patent information described in subsection (b)
could not be filed with the submission of an application under
subsection (b) because the application was filed before the
patent information was required under subsection (b) or a
patent was issued after the application was approved under such
subsection, the holder of an approved application shall file
with the Secretary, the patent number and the expiration date
of any patent which claims the drug for which the application
was submitted or which claims a method of using such drug and
with respect to which a claim of patent infringement could
reasonably be asserted if a person not licensed by the owner
engaged in the manufacture, use, or sale of the drug. If the
holder of an approved application could not file patent
information under subsection (b) because it was not required at
the time the application was approved, the holder shall file
such information under this subsection not later than thirty
days after the date of the enactment of this sentence, and if
the holder of an approved application could not file patent
information under subsection (b) because no patent had been
issued when an application was filed or approved, the holder
shall file such information under this subsection not later
than thirty days after after the date the patent involved is
issued. Upon the submission of patent information under this
subsection, the Secretary shall publish it.
(3) The approval of an application filed under subsection (b)
which contains a certification required by paragraph (2) of
such subsection shall be made effective on the last applicable
date determined by applying the following to each certification
made under subsection (b)(2)(A):
(A) If the applicant only made a certification
described in clause (i) or (ii) of subsection (b)(2)(A)
or in both such clauses, the approval may be made
effective immediately.
(B) If the applicant made a certification described
in clause (iii) of subsection (b)(2)(A), the approval
may be made effective on the date certified under
clause (iii).
(C) If the applicant made a certification described
in clause (iv) of subsection (b)(2)(A), the approval
shall be made effective immediately unless, before the
expiration of 45 days after the date on which the
notice described in subsection (b)(3) is received, an
action is brought for infringement of the patent that
is the subject of the certification and for which
information was submitted to the Secretary under
paragraph (2) or subsection (b)(1) before the date on
which the application (excluding an amendment or
supplement to the application) was submitted. If such
an action is brought before the expiration of such
days, the approval may be made effective upon the
expiration of the thirty-month period beginning on the
date of the receipt of the notice provided under
subsection (b)(3) or such shorter or longer period as
the court may order because either party to the action
failed to reasonably cooperate in expediting the
action, except that--
(i) if before the expiration of such period
the district court decides that the patent is
invalid or not infringed (including any
substantive determination that there is no
cause of action for patent infringement or
invalidity), the approval shall be made
effective on--
(I) the date on which the court
enters judgment reflecting the
decision; or
(II) the date of a settlement order
or consent decree signed and entered by
the court stating that the patent that
is the subject of the certification is
invalid or not infringed;
(ii) if before the expiration of such period
the district court decides that the patent has
been infringed--
(I) if the judgment of the district
court is appealed, the approval shall
be made effective on--
(aa) the date on which the
court of appeals decides that
the patent is invalid or not
infringed (including any
substantive determination that
there is no cause of action for
patent infringement or
invalidity); or
(bb) the date of a settlement
order or consent decree signed
and entered by the court of
appeals stating that the patent
that is the subject of the
certification is invalid or not
infringed; or
(II) if the judgment of the district
court is not appealed or is affirmed,
the approval shall be made effective on
the date specified by the district
court in a court order under section
271(e)(4)(A) of title 35, United States
Code;
(iii) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent is invalid or not
infringed, the approval shall be made effective
as provided in clause (i); or
(iv) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent has been infringed,
the approval shall be made effective as
provided in clause (ii).
In such an action, each of the parties shall reasonably
cooperate in expediting the action.
(D) Civil action to obtain patent certainty.--
(i) Declaratory judgment absent infringement
action.--
(I) In general.--No action may be
brought under section 2201 of title 28,
United States Code, by an applicant
referred to in subsection (b)(2) for a
declaratory judgment with respect to a
patent which is the subject of the
certification referred to in
subparagraph (C) unless--
(aa) the 45-day period
referred to in such
subparagraph has expired;
(bb) neither the owner of
such patent nor the holder of
the approved application under
subsection (b) for the drug
that is claimed by the patent
or a use of which is claimed by
the patent brought a civil
action against the applicant
for infringement of the patent
before the expiration of such
period; and
(cc) in any case in which the
notice provided under paragraph
(2)(B) relates to
noninfringement, the notice was
accompanied by a document
described in subclause (III).
(II) Filing of civil action.--If the
conditions described in items (aa),
(bb), and as applicable, (cc) of
subclause (I) have been met, the
applicant referred to in such subclause
may, in accordance with section 2201 of
title 28, United States Code, bring a
civil action under such section against
the owner or holder referred to in such
subclause (but not against any owner or
holder that has brought such a civil
action against the applicant, unless
that civil action was dismissed without
prejudice) for a declaratory judgment
that the patent is invalid or will not
be infringed by the drug for which the
applicant seeks approval, except that
such civil action may be brought for a
declaratory judgment that the patent
will not be infringed only in a case in
which the condition described in
subclause (I)(cc) is applicable. A
civil action referred to in this
subclause shall be brought in the
judicial district where the defendant
has its principal place of business or
a regular and established place of
business.
(III) Offer of confidential access to
application.--For purposes of subclause
(I)(cc), the document described in this
subclause is a document providing an
offer of confidential access to the
application that is in the custody of
the applicant referred to in subsection
(b)(2) for the purpose of determining
whether an action referred to in
subparagraph (C) should be brought. The
document providing the offer of
confidential access shall contain such
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, as would
apply had a protective order been
entered for the purpose of protecting
trade secrets and other confidential
business information. A request for
access to an application under an offer
of confidential access shall be
considered acceptance of the offer of
confidential access with the
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, contained
in the offer of confidential access,
and those restrictions and other terms
of the offer of confidential access
shall be considered terms of an
enforceable contract. Any person
provided an offer of confidential
access shall review the application for
the sole and limited purpose of
evaluating possible infringement of the
patent that is the subject of the
certification under subsection
(b)(2)(A)(iv) and for no other purpose,
and may not disclose information of no
relevance to any issue of patent
infringement to any person other than a
person provided an offer of
confidential access. Further, the
application may be redacted by the
applicant to remove any information of
no relevance to any issue of patent
infringement.
(ii) Counterclaim to infringement action.--
(I) In general.--If an owner of the
patent or the holder of the approved
application under subsection (b) for
the drug that is claimed by the patent
or a use of which is claimed by the
patent brings a patent infringement
action against the applicant, the
applicant may assert a counterclaim
seeking an order requiring the holder
to correct or delete the patent
information submitted by the holder
under subsection (b) or this subsection
on the ground that the patent does not
claim either--
(aa) the drug for which the
application was approved; or
(bb) an approved method of
using the drug.
(II) No independent cause of
action.--Subclause (I) does not
authorize the assertion of a claim
described in subclause (I) in any civil
action or proceeding other than a
counterclaim described in subclause
(I).
(iii) No damages.--An applicant shall not be
entitled to damages in a civil action under
clause (i) or a counterclaim under clause (ii).
(E)(i) If an application (other than an abbreviated
new drug application) submitted under subsection (b)
for a drug, no active ingredient (including any ester
or salt of the active ingredient) of which has been
approved in any other application under subsection (b),
was approved during the period beginning January 1,
1982, and ending on the date of the enactment of this
subsection, the Secretary may not make the approval of
another application for a drug for which the
investigations described in clause (A) of subsection
(b)(1) and relied upon by the applicant for approval of
the application were not conducted by or for the
applicant and for which the applicant has not obtained
a right of reference or use from the person by or for
whom the investigations were conducted effective before
the expiration of ten years from the date of the
approval of the application previously approved under
subsection (b).
(ii) If an application submitted under subsection (b)
for a drug, no active ingredient (including any ester
or salt of the active ingredient) of which has been
approved in any other application under subsection (b),
is approved after the date of the enactment of this
clause, no application which refers to the drug for
which the subsection (b) application was submitted and
for which the investigations described in clause (A) of
subsection (b)(1) and relied upon by the applicant for
approval of the application were not conducted by or
for the applicant and for which the applicant has not
obtained a right of reference or use from the person by
or for whom the investigations were conducted may be
submitted under subsection (b) before the expiration of
five years from the date of the approval of the
application under subsection (b), except that such an
application may be submitted under subsection (b) after
the expiration of four years from the date of the
approval of the subsection (b) application if it
contains a certification of patent invalidity or
noninfringement described in clause (iv) of subsection
(b)(2)(A). The approval of such an application shall be
made effective in accordance with this paragraph except
that, if an action for patent infringement is commenced
during the one-year period beginning forty-eight months
after the date of the approval of the subsection (b)
application, the thirty-month period referred to in
subparagraph (C) shall be extended by such amount of
time (if any) which is required for seven and one-half
years to have elapsed from the date of approval of the
subsection (b) application.
(iii) If an application submitted under subsection
(b) for a drug, which includes an active ingredient
(including any ester or salt of the active ingredient)
that has been approved in another application approved
under subsection (b), is approved after the date of the
enactment of this clause and if such application
contains reports of new clinical investigations (other
than bioavailability studies) essential to the approval
of the application and conducted or sponsored by the
applicant, the Secretary may not make the approval of
an application submitted under subsection (b) for the
conditions of approval of such drug in the approved
subsection (b) application effective before the
expiration of three years from the date of the approval
of the application under subsection (b) if the
investigations described in clause (A) of subsection
(b)(1) and relied upon by the applicant for approval of
the application were not conducted by or for the
applicant and if the applicant has not obtained a right
of reference or use from the person by or for whom the
investigations were conducted.
(iv) If a supplement to an application approved under
subsection (b) is approved after the date of enactment
of this clause and the supplement contains reports of
new clinical investigations (other than bioavailabilty
studies) essential to the approval of the supplement
and conducted or sponsored by the person submitting the
supplement, the Secretary may not make the approval of
an application submitted under subsection (b) for a
change approved in the supplement effective before the
expiration of three years from the date of the approval
of the supplement under subsection (b) if the
investigations described in clause (A) of subsection
(b)(1) and relied upon by the applicant for approval of
the application were not conducted by or for the
applicant and if the applicant has not obtained a right
of reference or use from the person by or for whom the
investigations were conducted.
(v) If an application (or supplement to an
application) submitted under subsection (b) for a drug,
which includes an active ingredient (including any
ester or salt of the active ingredient) that has been
approved in another application under subsection (b),
was approved during the period beginning January 1,
1982, and ending on the date of the enactment of this
clause, the Secretary may not make the approval of an
application submitted under this subsection and for
which the investigations described in clause (A) of
subsection (b)(1) and relied upon by the applicant for
approval of the application were not conducted by or
for the applicant and for which the applicant has not
obtained a right of reference or use from the person by
or for whom the investigations were conducted and which
refers to the drug for which the subsection (b)
application was submitted effective before the
expiration of two years from the date of enactment of
this clause.
(4) A drug manufactured in a pilot or other small facility
may be used to demonstrate the safety and effectiveness of the
drug and to obtain approval for the drug prior to manufacture
of the drug in a larger facility, unless the Secretary makes a
determination that a full scale production facility is
necessary to ensure the safety or effectiveness of the drug.
(5)(A) The Secretary may rely upon qualified data summaries
to support the approval of a supplemental application, with
respect to a qualified indication for a drug, submitted under
subsection (b), if such supplemental application complies with
subparagraph (B).
(B) A supplemental application is eligible for review as
described in subparagraph (A) only if--
(i) there is existing data available and acceptable
to the Secretary demonstrating the safety of the drug;
and
(ii) all data used to develop the qualified data
summaries are submitted to the Secretary as part of the
supplemental application.
(C) The Secretary shall post on the Internet website of the
Food and Drug Administration and update annually--
(i) the number of applications reviewed solely under
subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act;
(ii) the average time for completion of review under
subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act;
(iii) the average time for review of supplemental
applications where the Secretary did not use review
flexibility under subparagraph (A) or section
351(a)(2)(E) of the Public Health Service Act; and
(iv) the number of applications reviewed under
subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act for which the Secretary made use of
full data sets in addition to the qualified data
summary.
(D) In this paragraph--
(i) the term ``qualified indication'' means an
indication for a drug that the Secretary determines to
be appropriate for summary level review under this
paragraph; and
(ii) the term ``qualified data summary'' means a
summary of clinical data that demonstrates the safety
and effectiveness of a drug with respect to a qualified
indication.
(d) If the Secretary finds, after due notice to the applicant
in accordance with subsection (c) and giving him an opportunity
for a hearing, in accordance with said subsection, that (1) the
investigations, reports of which are required to be submitted
to the Secretary pursuant to subsection (b), do not include
adequate tests by all methods reasonably applicable to show
whether or not such drug is safe for use under the conditions
prescribed, recommended, or suggested in the proposed labeling
thereof; (2) the results of such tests show that such drug is
unsafe for use under such conditions or do not show that such
drug is safe for use under such conditions; (3) the methods
used in, and the facilities and controls used for, the
manufacture, processing, and packing of such drug are
inadequate to preserve its identity, strength, quality, and
purity; (4) upon the basis of the information submitted to him
as part of the application, or upon the basis of any other
information before him with respect to such drug, he has
insufficient information to determine whether such drug is safe
for use under such conditions; or (5) evaluated on the basis of
the information submitted to him as part of the application and
any other information before him with respect to such drug,
there is a lack of substantial evidence that the drug will have
the effect it purports or is represented to have under the
conditions of use prescribed, recommended, or suggested in the
proposed labeling thereof; or (6) the application failed to
contain the patent information prescribed by subsection (b); or
(7) based on a fair evaluation of all material facts, such
labeling is false or misleading in any particular; he shall
issue an order refusing to approve the application. If, after
such notice and opportunity for hearing, the Secretary finds
that clauses (1) through (6) do not apply, he shall issue an
order approving the application. As used in this subsection and
subsection (e), the term ``substantial evidence'' means
evidence consisting of adequate and well-controlled
investigations, including clinical investigations, by experts
qualified by scientific training and experience to evaluate the
effectiveness of the drug involved, on the basis of which it
could fairly and responsibly be concluded by such experts that
the drug will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling thereof. If the
Secretary determines, based on relevant science, that data from
one adequate and well-controlled clinical investigation and
confirmatory evidence (obtained prior to or after such
investigation) are sufficient to establish effectiveness, the
Secretary may consider such data and evidence to constitute
substantial evidence for purposes of the preceding sentence.
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 marketing approval of a drug.
(e) The Secretary shall, after due notice and opportunity for
hearing to the applicant, withdraw approval of an application
with respect to any drug under this section if the Secretary
finds (1) that clinical or other experience, tests, or other
scientific data show that such drug is unsafe for use under the
conditions of use upon the basis of which the application was
approved; (2) that new evidence of clinical experience, not
contained in such application or not available to the Secretary
until after such application was approved, or tests by new
methods, or tests by methods not deemed reasonably applicable
when such application was approved, evaluated together with the
evidence available to the Secretary when the application was
approved, shows that such drug is not shown to be safe for use
under the conditions of use upon the basis of which the
application was approved; or (3) on the basis of new
information before him with respect to such drug, evaluated
together with the evidence available to him when the
application was approved, that there is a lack of substantial
evidence that the drug will have the effect it purports or is
represented to have under the conditions of use prescribed,
recommended, or suggested in the labeling thereof; or (4) the
patent information prescribed by subsection (c) was not filed
within thirty days after the receipt of written notice from the
Secretary specifying the failure to file such information; or
(5) that the application contains any untrue statement of a
material fact: Provided, That if the Secretary (or in his
absence the officer acting as Secretary) finds that there is an
imminent hazard to the public health, he may suspend the
approval of such application immediately, and give the
applicant prompt notice of his action and afford the applicant
the opportunity for an expedited hearing under this subsection;
but the authority conferred by this proviso to suspend the
approval of an application shall not be delegated. The
Secretary may also, after due notice and opportunity for
hearing to the applicant, withdraw the approval of an
application submitted under subsection (b) or (j) with respect
to any drug under this section if the Secretary finds (1) that
the applicant has failed to establish a system for maintaining
required records, or has repeatedly or deliberately failed to
maintain such records or to make required reports, in
accordance with a regulation or order under subsection (k) or
to comply with the notice requirements of section 510(k)(2), or
the applicant has refused to permit access to, or copying or
verification of, such records as required by paragraph (2) of
such subsection; or (2) that on the basis of new information
before him, evaluated together with the evidence before him
when the application was approved, the methods used in, or the
facilities and controls used for, the manufacture, processing,
and packing of such drug are inadequate to assure and preserve
its identity, strength, quality, and purity and were not made
adequate within a reasonable time after receipt of written
notice from the Secretary specifying the matter complained of;
or (3) that on the basis of new information before him,
evaluated together with the evidence before him when the
application was approved, the labeling of such drug, based on a
fair evaluation of all material facts, is false or misleading
in any particular and was not corrected within a reasonable
time after receipt of written notice from the Secretary
specifying the matter complained of. Any order under this
subsection shall state the findings upon which it is based. The
Secretary may withdraw the approval of an application submitted
under this section, or suspend the approval of such an
application, as provided under this subsection, without first
ordering the applicant to submit an assessment of the approved
risk evaluation and mitigation strategy for the drug under
section 505-1(g)(2)(D).
(f) Whenever the Secretary finds that the facts so require,
he shall revoke any previous order under subsection (d) or (e)
refusing, withdrawing, or suspending approval of an application
and shall approve such application or reinstate such approval,
as may be appropriate.
(g) Orders of the Secretary issued under this section shall
be served (1) in person by any officer or employee of the
Department designated by the Secretary or (2) by mailing the
order by registered mail or by certified mail addressed to the
applicant or respondent at his last-known address in the
records of the Secretary.
(h) An appeal may be taken by the applicant from an order of
the Secretary refusing or withdrawing approval of an
application under this section. Such appeal shall be taken by
filing in the United States court of appeals for the circuit
wherein such applicant resides or has his principal place of
business, or in the United States Court of Appeals for the
District of Columbia Circuit, within sixty days after the entry
of such order, a written petition praying that the order of the
Secretary be set aside. A copy of such petition shall be
forthwith transmitted by the clerk of the court to the
Secretary, or any officer designated by him for that purpose,
and thereupon the Secretary shall certify and file in the court
the record upon which the order complained of was entered, as
provided in section 2112 of title 28, United States Code. Upon
the filing of such petition such court shall have exclusive
jurisdiction to affirm or set aside such order, except that
until the filing of the record the Secretary may modify or set
aside his order. No objection to the order of the Secretary
shall be considered by the court unless such objection shall
have been urged before the Secretary or unless there were
reasonable grounds for failure so to do. The finding of the
Secretary as to the facts, if supported by substantial
evidence, shall be conclusive. If any person shall apply to the
court for leave to adduce additional evidence, and shall show
to the satisfaction of the court that such additional evidence
is material and that there were reasonable grounds for failure
to adduce such evidence in the proceeding before the Secretary,
the court may order such additional evidence to be taken before
the Secretary and to be adduced upon the hearing in such manner
and upon such terms and conditions as to the court may seem
proper. The Secretary may modify his findings as to the facts
by reason of the additional evidence so taken, and he shall
file with the court such modified findings which, if supported
by substantial evidence, shall be conclusive, and his
recommendation, if any, for the setting aside of the original
order. The judgment of the court affirming or setting aside any
such order of the Secretary shall be final, subject to review
by the Supreme Court of the United States upon certiorari or
certification as provided in section 1254 of title 28 of the
United States Code. The commencement of proceedings under this
subsection shall not, unless specifically ordered by the court
to the contrary, operate as a stay of the Secretary's order.
(i)(1) The Secretary shall promulgate regulations for
exempting from the operation of the foregoing subsections of
this section drugs intended solely for investigational use by
experts qualified by scientific training and experience to
investigate the safety and effectiveness of drugs. Such
regulations may, within the discretion of the Secretary, among
other conditions relating to the protection of the public
health, provide for conditioning such exemption upon--
(A) the submission to the Secretary, before any
clinical testing of a new drug is undertaken, of
reports, by the manufacturer or the sponsor of the
investigation of such drug, or preclinical tests
(including tests on animals) of such drug adequate to
justify the proposed clinical testing;
(B) the manufacturer or the sponsor of the
investigation of a new drug proposed to be distributed
to investigators for clinical testing obtaining a
signed agreement from each of such investigators that
patients to whom the drug is administered will be under
his personal supervision, or under the supervision of
investigators responsible to him, and that he will not
supply such drug to any other investigator, or to
clinics, for administration to human beings;
(C) the establishment and maintenance of such
records, and the making of such reports to the
Secretary, by the manufacturer or the sponsor of the
investigation of such drug, of data (including but not
limited to analytical reports by investigators)
obtained as the result of such investigational use of
such drug, as the Secretary finds will enable him to
evaluate the safety and effectiveness of such drug in
the event of the filing of an application pursuant to
subsection (b); and
(D) the submission to the Secretary by the
manufacturer or the sponsor of the
investigation of a new drug of a statement of
intent regarding whether the manufacturer or
sponsor has plans for assessing pediatric
safety and efficacy.
(2) Subject to paragraph (3), a clinical investigation of a
new drug may begin 30 days after the Secretary has received
from the manufacturer or sponsor of the investigation a
submission containing such information about the drug and the
clinical investigation, including--
(A) information on design of the investigation and
adequate reports of basic information, certified by the
applicant to be accurate reports, necessary to assess
the safety of the drug for use in clinical
investigation; and
(B) adequate information on the chemistry and
manufacturing of the drug, controls available for the
drug, and primary data tabulations from animal or human
studies.
(3)(A) At any time, the Secretary may prohibit the sponsor of
an investigation from conducting the investigation (referred to
in this paragraph as a ``clinical hold'') if the Secretary
makes a determination described in subparagraph (B). The
Secretary shall specify the basis for the clinical hold,
including the specific information available to the Secretary
which served as the basis for such clinical hold, and confirm
such determination in writing.
(B) For purposes of subparagraph (A), a determination
described in this subparagraph with respect to a clinical hold
is that--
(i) the drug 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 drug, the design of the clinical
investigation, the condition for which the drug is to
be investigated, and the health status of the subjects
involved; or
(ii) the clinical hold should be issued for such
other reasons as the Secretary may by regulation
establish (including reasons established by regulation
before the date of the enactment of the Food and Drug
Administration Modernization Act of 1997).
(C) Any written request to the Secretary from the sponsor of
an investigation that a clinical hold be removed shall receive
a decision, in writing and specifying the reasons therefor,
within 30 days after receipt of such request. Any such request
shall include sufficient information to support the removal of
such clinical hold.
(4) Regulations under paragraph (1) shall provide that such
exemption shall be conditioned upon the manufacturer, or the
sponsor of the investigation, requiring that experts using such
drugs for investigational purposes certify to such manufacturer
or sponsor that they will inform any human beings to whom such
drugs, or any controls used in connection therewith, are being
administered, or their representatives, that such drugs are
being used for investigational purposes and will obtain the
consent of such human beings or their representatives, except
where it is not feasible, it is contrary to the best interests
of such human beings, or the proposed clinical testing poses no
more than minimal risk to such human beings and includes
appropriate safeguards as prescribed to protect the rights,
safety, and welfare of such human beings. Nothing in this
subsection shall be construed to require any clinical
investigator to submit directly to the Secretary reports on the
investigational use of drugs. The Secretary shall update such
regulations to require inclusion in the informed consent
documents and process a statement that clinical trial
information for such clinical investigation has been or will be
submitted for inclusion in the registry data bank pursuant to
subsection (j) of section 402 of the Public Health Service Act.
(j)(1) Any person may file with the Secretary an abbreviated
application for the approval of a new drug.
(2)(A) An abbreviated application for a new drug shall
contain--
(i) information to show that the conditions of use
prescribed, recommended, or suggested in the labeling
proposed for the new drug have been previously approved
for a drug listed under paragraph (7) (hereinafter in
this subsection referred to as a ``listed drug'');
(ii)(I) if the listed drug referred to in clause (i)
has only one active ingredient, information to show
that the active ingredient of the new drug is the same
as that of the listed drug;
(II) if the listed drug referred to in clause (i) has
more than one active ingredient, information to show
that the active ingredients of the new drug are the
same as those of the listed drug, or
(III) if the listed drug referred to in clause (i)
has more than one active ingredient and if one of the
active ingredients of the new drug is different and the
application is filed pursuant to the approval of a
petition filed under subparagraph (C), information to
show that the other active ingredients of the new drug
are the same as the active ingredients of the listed
drug, information to show that the different active
ingredient is an active ingredient of a listed drug or
of a drug which does not meet the requirements of
section 201(p), and such other information respecting
the different active ingredient with respect to which
the petition was filed as the Secretary may require;
(iii) information to show that the route of
administration, the dosage form, and the strength of
the new drug are the same as those of the listed drug
referred to in clause (i) or, if the route of
administration, the dosage form, or the strength of the
new drug is different and the application is filed
pursuant to the approval of a petition filed under
subparagraph (C), such information respecting the route
of administration, dosage form, or strength with
respect to which the petition was filed as the
Secretary may require;
(iv) information to show that the new drug is
bioequivalent to the listed drug referred to in clause
(i), except that if the application is filed pursuant
to the approval of a petition filed under subparagraph
(C), information to show that the active ingredients of
the new drug are of the same pharmacological or
therapeutic class as those of the listed drug referred
to in clause (i) and the new drug can be expected to
have the same therapeutic effect as the listed drug
when administered to patients for a condition of use
referred to in clause (i);
(v) information to show that the labeling proposed
for the new drug is the same as the labeling approved
for the listed drug referred to in clause (i) except
for changes required because of differences approved
under a petition filed under subparagraph (C) or
because the new drug and the listed drug are produced
or distributed by different manufacturers;
(vi) the items specified in clauses (B) through (F)
of subsection (b)(1);
(vii) a certification, in the opinion of the
applicant and to the best of his knowledge, with
respect to each patent which claims the listed drug
referred to in clause (i) or which claims a use for
such listed drug for which the applicant is seeking
approval under this subsection and for which
information is required to be filed under subsection
(b) or (c)--
(I) that such patent information has not been
filed,
(II) that such patent has expired,
(III) of the date on which such patent will
expire, or
(IV) that such patent is invalid or will not
be infringed by the manufacture, use, or sale
of the new drug for which the application is
submitted; and
(viii) if with respect to the listed drug referred to
in clause (i) information was filed under subsection
(b) or (c) for a method of use patent which does not
claim a use for which the applicant is seeking approval
under this subsection, a statement that the method of
use patent does not claim such a use.
The Secretary may not require that an abbreviated application
contain information in addition to that required by clauses (i)
through (viii).
(B) Notice of opinion that patent is invalid or will not be
infringed.--
(i) Agreement to give notice.--An applicant that
makes a certification described in subparagraph
(A)(vii)(IV) shall include in the application a
statement that the applicant will give notice as
required by this subparagraph.
(ii) Timing of notice.--An applicant that makes a
certification described in subparagraph (A)(vii)(IV)
shall give notice as required under this subparagraph--
(I) if the certification is in the
application, not later than 20 days after the
date of the postmark on the notice with which
the Secretary informs the applicant that the
application has been filed; or
(II) if the certification is in an amendment
or supplement to the application, at the time
at which the applicant submits the amendment or
supplement, regardless of whether the applicant
has already given notice with respect to
another such certification contained in the
application or in an amendment or supplement to
the application.
(iii) Recipients of notice.--An applicant required
under this subparagraph to give notice shall give
notice to--
(I) each owner of the patent that is the
subject of the certification (or a
representative of the owner designated to
receive such a notice); and
(II) the holder of the approved application
under subsection (b) for the drug that is
claimed by the patent or a use of which is
claimed by the patent (or a representative of
the holder designated to receive such a
notice).
(iv) Contents of notice.--A notice required under
this subparagraph shall--
(I) state that an application that contains
data from bioavailability or bioequivalence
studies has been submitted under this
subsection for the drug with respect to which
the certification is made to obtain approval to
engage in the commercial manufacture, use, or
sale of the drug before the expiration of the
patent referred to in the certification; and
(II) include a detailed statement of the
factual and legal basis of the opinion of the
applicant that the patent is invalid or will
not be infringed.
(C) If a person wants to submit an abbreviated application
for a new drug which has a different active ingredient or whose
route of administration, dosage form, or strength differ from
that of a listed drug, such person shall submit a petition to
the Secretary seeking permission to file such an application.
The Secretary shall approve or disapprove a petition submitted
under this subparagraph within ninety days of the date the
petition is submitted. The Secretary shall approve such a
petition unless the Secretary finds--
(i) that investigations must be conducted to show the
safety and effectiveness of the drug or of any of its
active ingredients, the route of administration, the
dosage form, or strength which differ from the listed
drug; or
(ii) that any drug with a different active ingredient
may not be adequately evaluated for approval as safe
and effective on the basis of the information required
to be submitted in an abbreviated application.
(D)(i) An applicant may not amend or supplement an
application to seek approval of a drug referring to a different
listed drug from the listed drug identified in the application
as submitted to the Secretary.
(ii) With respect to the drug for which an application is
submitted, nothing in this subsection prohibits an applicant
from amending or supplementing the application to seek approval
of a different strength.
(iii) Within 60 days after the date of the enactment of the
Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, the Secretary shall issue guidance defining the term
``listed drug'' for purposes of this subparagraph.
(3)(A) The Secretary shall issue guidance for the individuals
who review applications submitted under paragraph (1), which
shall relate to promptness in conducting the review, technical
excellence, lack of bias and conflict of interest, and
knowledge of regulatory and scientific standards, and which
shall apply equally to all individuals who review such
applications.
(B) The Secretary shall meet with a sponsor of an
investigation or an applicant for approval for a drug under
this subsection if the sponsor or applicant makes a reasonable
written request for a meeting for the purpose of reaching
agreement on the design and size of bioavailability and
bioequivalence studies needed for approval of such application.
The sponsor or applicant shall provide information necessary
for discussion and agreement on the design and size of such
studies. Minutes of any such meeting shall be prepared by the
Secretary and made available to the sponsor or applicant.
(C) Any agreement regarding the parameters of design and size
of bioavailability and bioequivalence studies of a drug under
this paragraph that is reached between the Secretary and a
sponsor or applicant shall be reduced to writing and made part
of the administrative record by the Secretary. Such agreement
shall not be changed after the testing begins, except--
(i) with the written agreement of the sponsor or
applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing
division, that a substantial scientific issue essential
to determining the safety or effectiveness of the drug
has been identified after the testing has begun.
(D) A decision under subparagraph (C)(ii) by the director
shall be in writing and the Secretary shall provide to the
sponsor or applicant an opportunity for a meeting at which the
director and the sponsor or applicant will be present and at
which the director will document the scientific issue involved.
(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by,
the field or compliance office personnel unless such field or
compliance office personnel demonstrate to the reviewing
division why such decision should be modified.
(F) No action by the reviewing division may be delayed
because of the unavailability of information from or action by
field personnel unless the reviewing division determines that a
delay is necessary to assure the marketing of a safe and
effective drug.
(G) For purposes of this paragraph, the reviewing division is
the division responsible for the review of an application for
approval of a drug under this subsection (including scientific
matters, chemistry, manufacturing, and controls).
(4) Subject to paragraph (5), the Secretary shall approve an
application for a drug unless the Secretary finds--
(A) the methods used in, or the facilities and
controls used for, the manufacture, processing, and
packing of the drug are inadequate to assure and
preserve its identity, strength, quality, and purity;
(B) information submitted with the application is
insufficient show that each of the proposed conditions
of use have been previously approved for the listed
drug referred to in the application;
(C)(i) if the listed drug has only one active
ingredient, information submitted with the application
is insufficient to show that the active ingredient is
the same as that of the listed drug;
(ii) if the listed drug has more than one active
ingredient, information submitted with the application
is insufficient to show that the active ingredients are
the same as the active ingredients of the listed drug,
or
(iii) if the listed drug has more than one active
ingredient and if the application is for a drug which
has an active ingredient different from the listed
drug, information submitted with the application is
insufficient to show--
(I) that the other active ingredients are the
same as the active ingredients of the listed
drug, or
(II) that the different active ingredient is
an active ingredient of a listed drug or a drug
which does not meet the requirements of section
201(p),
or no petition to file an application for the drug with
the different ingredient was approved under paragraph
(2)(C);
(D)(i) if the application is for a drug whose route
of administration, dosage form, or strength of the drug
is the same as the route of administration, dosage
form, or strength of the listed drug referred to in the
application, information submitted in the application
is insufficient to show that the route of
administration, dosage form, or strength is the same as
that of the listed drug, or
(ii) if the application is for a drug whose route of
administration, dosage form, or strength of the drug is
different from that of the listed drug referred to in
the application, no petition to file an application for
the drug with the different route of administration,
dosage form, or strength was approved under paragraph
(2)(C);
(E) if the application was filed pursuant to the
approval of a petition under paragraph (2)(C), the
application did not contain the information required by
the Secretary respecting the active ingredient, route
of administration, dosage form, or strength which is
not the same;
(F) information submitted in the application is
insufficient to show that the drug is bioequivalent to
the listed drug referred to in the application or, if
the application was filed pursuant to a petition
approved under paragraph (2)(C), information submitted
in the application is insufficient to show that the
active ingredients of the new drug are of the same
pharmacological or therapeutic class as those of the
listed drug referred to in paragraph (2)(A)(i) and that
the new drug can be expected to have the same
therapeutic effect as the listed drug when administered
to patients for a condition of use referred to in such
paragraph;
(G) information submitted in the application is
insufficient to show that the labeling proposed for the
drug is the same as the labeling approved for the
listed drug referred to in the application except for
changes required because of differences approved under
a petition filed under paragraph (2)(C) or because the
drug and the listed drug are produced or distributed by
different manufacturers;
(H) information submitted in the application or any
other information available to the Secretary shows that
(i) the inactive ingredients of the drug are unsafe for
use under the conditions prescribed, recommended, or
suggested in the labeling proposed for the drug, or
(ii) the composition of the drug is unsafe under such
conditions because of the type or quantity of inactive
ingredients included or the manner in which the
inactive ingredients are included;
(I) the approval under subsection (c) of the listed
drug referred to in the application under this
subsection has been withdrawn or suspended for grounds
described in the first sentence of subsection (e), the
Secretary has published a notice of opportunity for
hearing to withdraw approval of the listed drug under
subsection (c) for grounds described in the first
sentence of subsection (e), the approval under this
subsection of the listed drug referred to in the
application under this subsection has been withdrawn or
suspended under paragraph (6), or the Secretary has
determined that the listed drug has been withdrawn from
sale for safety or effectiveness reasons;
(J) the application does not meet any other
requirement of paragraph (2)(A); or
(K) the application contains an untrue statement of
material fact.
(5)(A) Within one hundred and eighty days of the initial
receipt of an application under paragraph (2) or within such
additional period as may be agreed upon by the Secretary and
the applicant, the Secretary shall approve or disapprove the
application.
(B) The approval of an application submitted under paragraph
(2) shall be made effective on the last applicable date
determined by applying the following to each certification made
under paragraph (2)(A)(vii):
(i) If the applicant only made a certification
described in subclause (I) or (II) of paragraph
(2)(A)(vii) or in both such subclauses, the approval
may be made effective immediately.
(ii) If the applicant made a certification described
in subclause (III) of paragraph (2)(A)(vii), the
approval may be made effective on the date certified
under subclause (III).
(iii) If the applicant made a certification described
in subclause (IV) of paragraph (2)(A)(vii), the
approval shall be made effective immediately unless,
before the expiration of 45 days after the date on
which the notice described in paragraph (2)(B) is
received, an action is brought for infringement of the
patent that is the subject of the certification and for
which information was submitted to the Secretary under
subsection (b)(1) or (c)(2) before the date on which
the application (excluding an amendment or supplement
to the application), which the Secretary later
determines to be substantially complete, was submitted.
If such an action is brought before the expiration of
such days, the approval shall be made effective upon
the expiration of the thirty-month period beginning on
the date of the receipt of the notice provided under
paragraph (2)(B)(i) or such shorter or longer period as
the court may order because either party to the action
failed to reasonably cooperate in expediting the
action, except that--
(I) if before the expiration of such period
the district court decides that the patent is
invalid or not infringed (including any
substantive determination that there is no
cause of action for patent infringement or
invalidity), the approval shall be made
effective on--
(aa) the date on which the court
enters judgment reflecting the
decision; or
(bb) the date of a settlement order
or consent decree signed and entered by
the court stating that the patent that
is the subject of the certification is
invalid or not infringed;
(II) if before the expiration of such period
the district court decides that the patent has
been infringed--
(aa) if the judgment of the district
court is appealed, the approval shall
be made effective on--
(AA) the date on which the
court of appeals decides that
the patent is invalid or not
infringed (including any
substantive determination that
there is no cause of action for
patent infringement or
invalidity); or
(BB) the date of a settlement
order or consent decree signed
and entered by the court of
appeals stating that the patent
that is the subject of the
certification is invalid or not
infringed; or
(bb) if the judgment of the district
court is not appealed or is affirmed,
the approval shall be made effective on
the date specified by the district
court in a court order under section
271(e)(4)(A) of title 35, United States
Code;
(III) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent is invalid or not
infringed, the approval shall be made effective
as provided in subclause (I); or
(IV) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent has been infringed,
the approval shall be made effective as
provided in subclause (II).
In such an action, each of the parties shall reasonably
cooperate in expediting the action.
(iv) 180-day exclusivity period.--
(I) Effectiveness of application.--Subject to
subparagraph (D), if the application contains a
certification described in paragraph
(2)(A)(vii)(IV) and is for a drug for which a
first applicant has submitted an application
containing such a certification, the
application shall be made effective on the date
that is 180 days after the date of the first
commercial marketing of the drug (including the
commercial marketing of the listed drug) by any
first applicant.
(II) Definitions.--In this paragraph:
(aa) 180-day exclusivity period.--
The term ``180-day exclusivity period''
means the 180-day period ending on the
day before the date on which an
application submitted by an applicant
other than a first applicant could
become effective under this clause.
(bb) First applicant.--As used in
this subsection, the term ``first
applicant'' means an applicant that, on
the first day on which a substantially
complete application containing a
certification described in paragraph
(2)(A)(vii)(IV) is submitted for
approval of a drug, submits a
substantially complete application that
contains and lawfully maintains a
certification described in paragraph
(2)(A)(vii)(IV) for the drug.
(cc) Substantially complete
application.--As used in this
subsection, the term ``substantially
complete application'' means an
application under this subsection that
on its face is sufficiently complete to
permit a substantive review and
contains all the information required
by paragraph (2)(A).
(dd) Tentative approval.--
(AA) In general.--The term
``tentative approval'' means
notification to an applicant by
the Secretary that an
application under this
subsection meets the
requirements of paragraph
(2)(A), but cannot receive
effective approval because the
application does not meet the
requirements of this
subparagraph, there is a period
of exclusivity for the listed
drug under subparagraph (F) or
section 505A, or there is a 7-
year period of exclusivity for
the listed drug under section
527.
(BB) Limitation.--A drug that
is granted tentative approval
by the Secretary is not an
approved drug and shall not
have an effective approval
until the Secretary issues an
approval after any necessary
additional review of the
application.
(v) 180-day exclusivity period for competitive
generic therapies.--
(I) Effectiveness of application.--Subject to
subparagraph (D)(iv), if the application is for
a drug that is the same as a competitive
generic therapy for which any first approved
applicant has commenced commercial marketing,
the application shall be made effective on the
date that is 180 days after the date of the
first commercial marketing of the competitive
generic therapy (including the commercial
marketing of the listed drug) by any first
approved applicant.
(II) Limitation.--The exclusivity period
under subclause (I) shall not apply with
respect to a competitive generic therapy that
has previously received an exclusivity period
under subclause (I).
(III) Definitions.--In this clause and
subparagraph (D)(iv):
(aa) The term ``competitive generic
therapy'' means a drug--
(AA) that is designated as a
competitive generic therapy
under section 506H; and
(BB) for which there are no
unexpired patents or blocking
exclusivities on the list of
products described in section
505(j)(7)(A) at the time of
approval.
(bb) The term ``first approved
applicant'' means any applicant that
has submitted an application that--
(AA) is for a competitive
generic therapy that is
approved on the first day on
which any application for such
competitive generic therapy is
approved;
(BB) is not eligible for a
180-day exclusivity period
under clause (iv) for the drug
that is the subject of the
application for the competitive
generic therapy; and
(CC) is not for a drug for
which all drug versions have
forfeited eligibility for a
180-day exclusivity period
under clause (iv) pursuant to
subparagraph (D).
(C) Civil action to obtain patent certainty.--
(i) Declaratory judgment absent infringement
action.--
(I) In general.--No action may be
brought under section 2201 of title 28,
United States Code, by an applicant
under paragraph (2) for a declaratory
judgment with respect to a patent which
is the subject of the certification
referred to in subparagraph (B)(iii)
unless--
(aa) the 45-day period
referred to in such
subparagraph has expired;
(bb) neither the owner of
such patent nor the holder of
the approved application under
subsection (b) for the drug
that is claimed by the patent
or a use of which is claimed by
the patent brought a civil
action against the applicant
for infringement of the patent
before the expiration of such
period; and
(cc) in any case in which the
notice provided under paragraph
(2)(B) relates to
noninfringement, the notice was
accompanied by a document
described in subclause (III).
(II) Filing of civil action.--If the
conditions described in items (aa),
(bb), and as applicable, (cc) of
subclause (I) have been met, the
applicant referred to in such subclause
may, in accordance with section 2201 of
title 28, United States Code, bring a
civil action under such section against
the owner or holder referred to in such
subclause (but not against any owner or
holder that has brought such a civil
action against the applicant, unless
that civil action was dismissed without
prejudice) for a declaratory judgment
that the patent is invalid or will not
be infringed by the drug for which the
applicant seeks approval, except that
such civil action may be brought for a
declaratory judgment that the patent
will not be infringed only in a case in
which the condition described in
subclause (I)(cc) is applicable. A
civil action referred to in this
subclause shall be brought in the
judicial district where the defendant
has its principal place of business or
a regular and established place of
business.
(III) Offer of confidential access to
application.--For purposes of subclause
(I)(cc), the document described in this
subclause is a document providing an
offer of confidential access to the
application that is in the custody of
the applicant under paragraph (2) for
the purpose of determining whether an
action referred to in subparagraph
(B)(iii) should be brought. The
document providing the offer of
confidential access shall contain such
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, as would
apply had a protective order been
entered for the purpose of protecting
trade secrets and other confidential
business information. A request for
access to an application under an offer
of confidential access shall be
considered acceptance of the offer of
confidential access with the
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, contained
in the offer of confidential access,
and those restrictions and other terms
of the offer of confidential access
shall be considered terms of an
enforceable contract. Any person
provided an offer of confidential
access shall review the application for
the sole and limited purpose of
evaluating possible infringement of the
patent that is the subject of the
certification under paragraph
(2)(A)(vii)(IV) and for no other
purpose, and may not disclose
information of no relevance to any
issue of patent infringement to any
person other than a person provided an
offer of confidential access. Further,
the application may be redacted by the
applicant to remove any information of
no relevance to any issue of patent
infringement.
(ii) Counterclaim to infringement action.--
(I) In general.--If an owner of the
patent or the holder of the approved
application under subsection (b) for
the drug that is claimed by the patent
or a use of which is claimed by the
patent brings a patent infringement
action against the applicant, the
applicant may assert a counterclaim
seeking an order requiring the holder
to correct or delete the patent
information submitted by the holder
under subsection (b) or (c) on the
ground that the patent does not claim
either--
(aa) the drug for which the
application was approved; or
(bb) an approved method of
using the drug.
(II) No independent cause of
action.--Subclause (I) does not
authorize the assertion of a claim
described in subclause (I) in any civil
action or proceeding other than a
counterclaim described in subclause
(I).
(iii) No damages.--An applicant shall not be
entitled to damages in a civil action under
clause (i) or a counterclaim under clause (ii).
(D) Forfeiture of 180-day exclusivity period.--
(i) Definition of forfeiture event.--In this
subparagraph, the term ``forfeiture event'',
with respect to an application under this
subsection, means the occurrence of any of the
following:
(I) Failure to market.--The first
applicant fails to market the drug by
the later of--
(aa) the earlier of the date
that is--
(AA) 75 days after
the date on which the
approval of the
application of the
first applicant is made
effective under
subparagraph (B)(iii);
or
(BB) 30 months after
the date of submission
of the application of
the first applicant; or
(bb) with respect to the
first applicant or any other
applicant (which other
applicant has received
tentative approval), the date
that is 75 days after the date
as of which, as to each of the
patents with respect to which
the first applicant submitted
and lawfully maintained a
certification qualifying the
first applicant for the 180-day
exclusivity period under
subparagraph (B)(iv), at least
1 of the following has
occurred:
(AA) In an
infringement action
brought against that
applicant with respect
to the patent or in a
declaratory judgment
action brought by that
applicant with respect
to the patent, a court
enters a final decision
from which no appeal
(other than a petition
to the Supreme Court
for a writ of
certiorari) has been or
can be taken that the
patent is invalid or
not infringed.
(BB) In an
infringement action or
a declaratory judgment
action described in
subitem (AA), a court
signs a settlement
order or consent decree
that enters a final
judgment that includes
a finding that the
patent is invalid or
not infringed.
(CC) The patent
information submitted
under subsection (b) or
(c) is withdrawn by the
holder of the
application approved
under subsection (b).
(II) Withdrawal of application.--The
first applicant withdraws the
application or the Secretary considers
the application to have been withdrawn
as a result of a determination by the
Secretary that the application does not
meet the requirements for approval
under paragraph (4).
(III) Amendment of certification.--
The first applicant amends or withdraws
the certification for all of the
patents with respect to which that
applicant submitted a certification
qualifying the applicant for the 180-
day exclusivity period.
(IV) Failure to obtain tentative
approval.--The first applicant fails to
obtain tentative approval of the
application within 30 months after the
date on which the application is filed,
unless the failure is caused by a
change in or a review of the
requirements for approval of the
application imposed after the date on
which the application is filed.
(V) Agreement with another applicant,
the listed drug application holder, or
a patent owner.--The first applicant
enters into an agreement with another
applicant under this subsection for the
drug, the holder of the application for
the listed drug, or an owner of the
patent that is the subject of the
certification under paragraph
(2)(A)(vii)(IV), the Federal Trade
Commission or the Attorney General
files a complaint, and there is a final
decision of the Federal Trade
Commission or the court with regard to
the complaint from which no appeal
(other than a petition to the Supreme
Court for a writ of certiorari) has
been or can be taken that the agreement
has violated the antitrust laws (as
defined in section 1 of the Clayton Act
(15 U.S.C. 12), except that the term
includes section 5 of the Federal Trade
Commission Act (15 U.S.C. 45) to the
extent that that section applies to
unfair methods of competition).
(VI) Expiration of all patents.--All
of the patents as to which the
applicant submitted a certification
qualifying it for the 180-day
exclusivity period have expired.
(ii) Forfeiture.--The 180-day exclusivity
period described in subparagraph (B)(iv) shall
be forfeited by a first applicant if a
forfeiture event occurs with respect to that
first applicant.
(iii) Subsequent applicant.--If all first
applicants forfeit the 180-day exclusivity
period under clause (ii)--
(I) approval of any application
containing a certification described in
paragraph (2)(A)(vii)(IV) shall be made
effective in accordance with
subparagraph (B)(iii); and
(II) no applicant shall be eligible
for a 180-day exclusivity period.
(iv) Special forfeiture rule for competitive
generic therapy.--The 180-day exclusivity
period described in subparagraph (B)(v) shall
be forfeited by a first approved applicant if
the applicant fails to market the competitive
generic therapy within 75 days after the date
on which the approval of the first approved
applicant's application for the competitive
generic therapy is made effective.
(E) If the Secretary decides to disapprove an application,
the Secretary shall give the applicant notice of an opportunity
for a hearing before the Secretary on the question of whether
such application is approvable. If the applicant elects to
accept the opportunity for hearing by written request within
thirty days after such notice, such hearing shall commence not
more than ninety days after the expiration of such thirty days
unless the Secretary and the applicant otherwise agree. Any
such hearing shall thereafter be conducted on an expedited
basis and the Secretary's order thereon shall be issued within
ninety days after the date fixed by the Secretary for filing
final briefs.
(F)(i) If an application (other than an abbreviated new drug
application) submitted under subsection (b) for a drug, no
active ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other application
under subsection (b), was approved during the period beginning
January 1, 1982, and ending on the date of the enactment of
this subsection, the Secretary may not make the approval of an
application submitted under this subsection which refers to the
drug for which the subsection (b) application was submitted
effective before the expiration of ten years from the date of
the approval of the application under subsection (b).
(ii) If an application submitted under subsection (b) for a
drug, no active ingredient (including any ester or salt of the
active ingredient) of which has been approved in any other
application under subsection (b), is approved after the date of
the enactment of this subsection, no application may be
submitted under this subsection which refers to the drug for
which the subsection (b) application was submitted before the
expiration of five years from the date of the approval of the
application under subsection (b), except that such an
application may be submitted under this subsection after the
expiration of four years from the date of the approval of the
subsection (b) application if it contains a certification of
patent invalidity or noninfringement described in subclause
(IV) of paragraph (2)(A)(vii). The approval of such an
application shall be made effective in accordance with
subparagraph (B) except that, if an action for patent
infringement is commenced during the one-year period beginning
forty-eight months after the date of the approval of the
subsection (b) application, the thirty-month period referred to
in subparagraph (B)(iii) shall be extended by such amount of
time (if any) which is required for seven and one-half years to
have elapsed from the date of approval of the subsection (b)
application.
(iii) If an application submitted under subsection (b) for a
drug, which includes an active ingredient (including any ester
or salt of the active ingredient) that has been approved in
another application approved under subsection (b), is approved
after the date of enactment of this subsection and if such
application contains reports of new clinical investigations
(other than bioavailability studies) essential to the approval
of the application and conducted or sponsored by the applicant,
the Secretary may not make the approval of an application
submitted under this subsection for the conditions of approval
of such drug in the subsection (b) application effective before
the expiration of three years from the date of the approval of
the application under subsection (b) for such drug.
(iv) If a supplement to an application approved under
subsection (b) is approved after the date of enactment of this
subsection and the supplement contains reports of new clinical
investigations (other than bioavailability studies) essential
to the approval of the supplement and conducted or sponsored by
the person submitting the supplement, the Secretary may not
make the approval of an application submitted under this
subsection for a change approved in the supplement effective
before the expiration of three years from the date of the
approval of the supplement under subsection (b).
(v) If an application (or supplement to an application)
submitted under subsection (b) for a drug, which includes an
active ingredient (including any ester or salt of the active
ingredient) that has been approved in another application under
subsection (b), was approved during the period beginning
January 1, 1982, and ending on the date of the enactment of
this subsection, the Secretary may not make the approval of an
application submitted under this subsection which refers to the
drug for which the subsection (b) application was submitted or
which refers to a change approved in a supplement to the
subsection (b) application effective before the expiration of
two years from the date of enactment of this subsection.
(6) If a drug approved under this subsection refers in its
approved application to a drug the approval of which was
withdrawn or suspended for grounds described in the first
sentence of subsection (e) or was withdrawn or suspended under
this paragraph or which, as determined by the Secretary, has
been withdrawn from sale for safety or effectiveness reasons,
the approval of the drug under this subsection shall be
withdrawn or suspended--
(A) for the same period as the withdrawal or
suspension under subsection (e) or this paragraph, or
(B) if the listed drug has been withdrawn from sale,
for the period of withdrawal from sale or, if earlier,
the period ending on the date the Secretary determines
that the withdrawal from sale is not for safety or
effectiveness reasons.
(7)(A)(i) Within sixty days of the date of the enactment of
this subsection, the Secretary shall publish and make available
to the public--
(I) a list in alphabetical order of the official and
proprietary name of each drug which has been approved
for safety and effectiveness under subsection (c)
before the date of the enactment of this subsection;
(II) the date of approval if the drug is approved
after 1981 and the number of the application which was
approved; and
(III) whether in vitro or in vivo bioequivalence
studies, or both such studies, are required for
applications filed under this subsection which will
refer to the drug published.
(ii) Every thirty days after the publication of the first
list under clause (i) the Secretary shall revise the list to
include each drug which has been approved for safety and
effectiveness under subsection (c) or approved under this
subsection during the thirty-day period.
(iii) When patent information submitted under subsection (b)
or (c) respecting a drug included on the list is to be
published by the Secretary, the Secretary shall, in revisions
made under clause (ii), include such information for such drug.
(B) A drug approved for safety and effectiveness under
subsection (c) or approved under this subsection shall, for
purposes of this subsection, be considered to have been
published under subparagraph (A) on the date of its approval or
the date of enactment, whichever is later.
(C) If the approval of a drug was withdrawn or suspended for
grounds described in the first sentence of subsection (e) or
was withdrawn or suspended under paragraph (6) or if the
Secretary determines that a drug has been withdrawn from sale
for safety or effectiveness reasons, it may not be published in
the list under subparagraph (A) or, if the withdrawal or
suspension occurred after its publication in such list, it
shall be immediately removed from such list--
(i) for the same period as the withdrawal or
suspension under subsection (e) or paragraph (6), or
(ii) if the listed drug has been withdrawn from sale,
for the period of withdrawal from sale or, if earlier,
the period ending on the date the Secretary determines
that the withdrawal from sale is not for safety or
effectiveness reasons.
A notice of the removal shall be published in the Federal
Register.
(8) For purposes of this subsection:
(A)(i) The term ``bioavailability'' means the rate
and extent to which the active ingredient or
therapeutic ingredient is absorbed from a drug and
becomes available at the site of drug action.
(ii) For a drug that is not intended to be absorbed
into the bloodstream, the Secretary may assess
bioavailability by scientifically valid measurements
intended to reflect the rate and extent to which the
active ingredient or therapeutic ingredient becomes
available at the site of drug action.
(B) A drug shall be considered to be bioequivalent to
a listed drug if--
(i) the rate and extent of absorption of the
drug do not show a significant difference from
the rate and extent of absorption of the listed
drug when administered at the same molar dose
of the therapeutic ingredient under similar
experimental conditions in either a single dose
or multiple doses; or
(ii) the extent of absorption of the drug
does not show a significant difference from the
extent of absorption of the listed drug when
administered at the same molar dose of the
therapeutic ingredient under similar
experimental conditions in either a single dose
or multiple doses and the difference from the
listed drug in the rate of absorption of the
drug is intentional, is reflected in its
proposed labeling, is not essential to the
attainment of effective body drug
concentrations on chronic use, and is
considered medically insignificant for the
drug.
(C) For a drug that is not intended to be absorbed
into the bloodstream, the Secretary may establish
alternative, scientifically valid methods to show
bioequivalence if the alternative methods are expected
to detect a significant difference between the drug and
the listed drug in safety and therapeutic effect.
(9) The Secretary shall, with respect to each application
submitted under this subsection, maintain a record of--
(A) the name of the applicant,
(B) the name of the drug covered by the application,
(C) the name of each person to whom the review of the
chemistry of the application was assigned and the date
of such assignment, and
(D) the name of each person to whom the
bioequivalence review for such application was assigned
and the date of such assignment.
The information the Secretary is required to maintain under
this paragraph with respect to an application submitted under
this subsection shall be made available to the public after the
approval of such application.
(10)(A) If the proposed labeling of a drug that is the
subject of an application under this subsection differs from
the listed drug due to a labeling revision described under
clause (i), the drug that is the subject of such application
shall, notwithstanding any other provision of this Act, be
eligible for approval and shall not be considered misbranded
under section 502 if--
(i) the application is otherwise eligible for
approval under this subsection but for expiration of
patent, an exclusivity period, or of a delay in
approval described in paragraph (5)(B)(iii), and a
revision to the labeling of the listed drug has been
approved by the Secretary within 60 days of such
expiration;
(ii) the labeling revision described under clause (i)
does not include a change to the ``Warnings'' section
of the labeling;
(iii) the sponsor of the application under this
subsection agrees to submit revised labeling of the
drug that is the subject of such application not later
than 60 days after the notification of any changes to
such labeling required by the Secretary; and
(iv) such application otherwise meets the applicable
requirements for approval under this subsection.
(B) If, after a labeling revision described in subparagraph
(A)(i), the Secretary determines that the continued presence in
interstate commerce of the labeling of the listed drug (as in
effect before the revision described in subparagraph (A)(i))
adversely impacts the safe use of the drug, no application
under this subsection shall be eligible for approval with such
labeling.
(11) Upon the request of an applicant regarding one or more
specified pending applications under this subsection, the
Secretary shall--
(A) by telephone or electronic mail, provide review
status updates; and
(B) indicate in such updates the categorical status
of the applications by each relevant review discipline.
(k)(1) In the case of any drug for which an approval of an
application filed under subsection (b) or (j) is in effect, the
applicant shall establish and maintain such records, and make
such reports to the Secretary, of data relating to clinical
experience and other data or information, received or otherwise
obtained by such applicant with respect to such drug, as the
Secretary may by general regulation, or by order with respect
to such application, prescribe on the basis of a finding that
such records and reports are necessary in order to enable the
Secretary to determine, or facilitate a determination, whether
there is or may be ground for invoking subsection (e) of this
section. Regulations and orders issued under this subsection
and under subsection (i) shall have due regard for the
professional ethics of the medical profession and the interests
of patients and shall provide, where the Secretary deems it to
be appropriate, for the examination, upon request, by the
persons to whom such regulations or orders are applicable, of
similar information received or otherwise obtained by the
Secretary.
(2) Every person required under this section to maintain
records, and every person in charge or custody thereof, shall,
upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable
times to have access to and copy and verify such records.
(3) Active postmarket risk identification.--
(A) Definition.--In this paragraph, the term
``data'' refers to information with respect to
a drug approved under this section or under
section 351 of the Public Health Service Act,
including claims data, patient survey data,
standardized analytic files that allow for the
pooling and analysis of data from disparate
data environments, and any other data deemed
appropriate by the Secretary.
(B) Development of postmarket risk
identification and analysis methods.--The
Secretary shall, not later than 2 years after
the date of the enactment of the Food and Drug
Administration Amendments Act of 2007, in
collaboration with public, academic, and
private entities--
(i) develop methods to obtain access
to disparate data sources including the
data sources specified in subparagraph
(C);
(ii) develop validated methods for
the establishment of a postmarket risk
identification and analysis system to
link and analyze safety data from
multiple sources, with the goals of
including, in aggregate--
(I) at least 25,000,000
patients by July 1, 2010; and
(II) at least 100,000,000
patients by July 1, 2012; and
(iii) convene a committee of experts,
including individuals who are
recognized in the field of protecting
data privacy and security, to make
recommendations to the Secretary on the
development of tools and methods for
the ethical and scientific uses for,
and communication of, postmarketing
data specified under subparagraph (C),
including recommendations on the
development of effective research
methods for the study of drug safety
questions.
(C) Establishment of the postmarket risk
identification and analysis system.--
(i) In general.--The Secretary shall,
not later than 1 year after the
development of the risk identification
and analysis methods under subparagraph
(B), establish and maintain
procedures--
(I) for risk identification
and analysis based on
electronic health data, in
compliance with the regulations
promulgated under section
264(c) of the Health Insurance
Portability and Accountability
Act of 1996, and in a manner
that does not disclose
individually identifiable
health information in violation
of paragraph (4)(B);
(II) for the reporting (in a
standardized form) of data on
all serious adverse drug
experiences (as defined in
section 505-1(b)) submitted to
the Secretary under paragraph
(1), and those adverse events
submitted by patients,
providers, and drug sponsors,
when appropriate;
(III) to provide for active
adverse event surveillance
using the following data
sources, as available:
(aa) Federal health-
related electronic data
(such as data from the
Medicare program and
the health systems of
the Department of
Veterans Affairs);
(bb) private sector
health-related
electronic data (such
as pharmaceutical
purchase data and
health insurance claims
data); and
(cc) other data as
the Secretary deems
necessary to create a
robust system to
identify adverse events
and potential drug
safety signals;
(IV) to identify certain
trends and patterns with
respect to data accessed by the
system;
(V) to provide regular
reports to the Secretary
concerning adverse event
trends, adverse event patterns,
incidence and prevalence of
adverse events, and other
information the Secretary
determines appropriate, which
may include data on comparative
national adverse event trends;
and
(VI) to enable the program to
export data in a form
appropriate for further
aggregation, statistical
analysis, and reporting.
(ii) Timeliness of reporting.--The
procedures established under clause (i)
shall ensure that such data are
accessed, analyzed, and reported in a
timely, routine, and systematic manner,
taking into consideration the need for
data completeness, coding, cleansing,
and standardized analysis and
transmission.
(iii) Private sector resources.--To
ensure the establishment of the active
postmarket risk identification and
analysis system under this subsection
not later than 1 year after the
development of the risk identification
and analysis methods under subparagraph
(B), as required under clause (i), the
Secretary may, on a temporary or
permanent basis, implement systems or
products developed by private entities.
(iv) Complementary approaches.--To
the extent the active postmarket risk
identification and analysis system
under this subsection is not sufficient
to gather data and information relevant
to a priority drug safety question, the
Secretary shall develop, support, and
participate in complementary approaches
to gather and analyze such data and
information, including--
(I) approaches that are
complementary with respect to
assessing the safety of use of
a drug in domestic populations
not included, or
underrepresented, in the trials
used to approve the drug (such
as older people, people with
comorbidities, pregnant women,
or children); and
(II) existing approaches such
as the Vaccine Adverse Event
Reporting System and the
Vaccine Safety Datalink or
successor databases.
(v) Authority for contracts.--The
Secretary may enter into contracts with
public and private entities to fulfill
the requirements of this subparagraph.
(4) Advanced analysis of drug safety data.--
(A) Purpose.--The Secretary shall establish
collaborations with public, academic, and
private entities, which may include the Centers
for Education and Research on Therapeutics
under section 912 of the Public Health Service
Act, to provide for advanced analysis of drug
safety data described in paragraph (3)(C) and
other information that is publicly available or
is provided by the Secretary, in order to--
(i) improve the quality and
efficiency of postmarket drug safety
risk-benefit analysis;
(ii) provide the Secretary with
routine access to outside expertise to
study advanced drug safety questions;
and
(iii) enhance the ability of the
Secretary to make timely assessments
based on drug safety data.
(B) Privacy.--Such analysis shall not
disclose individually identifiable health
information when presenting such drug safety
signals and trends or when responding to
inquiries regarding such drug safety signals
and trends.
(C) Public process for priority questions.--
At least biannually, the Secretary shall seek
recommendations from the Drug Safety and Risk
Management Advisory Committee (or any successor
committee) and from other advisory committees,
as appropriate, to the Food and Drug
Administration on--
(i) priority drug safety questions;
and
(ii) mechanisms for answering such
questions, including through--
(I) active risk
identification under paragraph
(3); and
(II) when such risk
identification is not
sufficient, postapproval
studies and clinical trials
under subsection (o)(3).
(D) Procedures for the development of drug
safety collaborations.--
(i) In general.--Not later than 180
days after the date of the
establishment of the active postmarket
risk identification and analysis system
under this subsection, the Secretary
shall establish and implement
procedures under which the Secretary
may routinely contract with one or more
qualified entities to--
(I) classify, analyze, or
aggregate data described in
paragraph (3)(C) and
information that is publicly
available or is provided by the
Secretary;
(II) allow for prompt
investigation of priority drug
safety questions, including--
(aa) unresolved
safety questions for
drugs or classes of
drugs; and
(bb) for a newly-
approved drugs, safety
signals from clinical
trials used to approve
the drug and other
preapproval trials;
rare, serious drug side
effects; and the safety
of use in domestic
populations not
included, or
underrepresented, in
the trials used to
approve the drug (such
as older people, people
with comorbidities,
pregnant women, or
children);
(III) perform advanced
research and analysis on
identified drug safety risks;
(IV) focus postapproval
studies and clinical trials
under subsection (o)(3) more
effectively on cases for which
reports under paragraph (1) and
other safety signal detection
is not sufficient to resolve
whether there is an elevated
risk of a serious adverse event
associated with the use of a
drug; and
(V) carry out other
activities as the Secretary
deems necessary to carry out
the purposes of this paragraph.
(ii) Request for specific
methodology.--The procedures described
in clause (i) shall permit the
Secretary to request that a specific
methodology be used by the qualified
entity. The qualified entity shall work
with the Secretary to finalize the
methodology to be used.
(E) Use of analyses.--The Secretary shall
provide the analyses described in this
paragraph, including the methods and results of
such analyses, about a drug to the sponsor or
sponsors of such drug.
(F) Qualified entities.--
(i) In general.--The Secretary shall
enter into contracts with a sufficient
number of qualified entities to develop
and provide information to the
Secretary in a timely manner.
(ii) Qualification.--The Secretary
shall enter into a contract with an
entity under clause (i) only if the
Secretary determines that the entity
has a significant presence in the
United States and has one or more of
the following qualifications:
(I) The research,
statistical, epidemiologic, or
clinical capability and
expertise to conduct and
complete the activities under
this paragraph, including the
capability and expertise to
provide the Secretary de-
identified data consistent with
the requirements of this
subsection.
(II) An information
technology infrastructure in
place to support electronic
data and operational standards
to provide security for such
data.
(III) Experience with, and
expertise on, the development
of drug safety and
effectiveness research using
electronic population data.
(IV) An understanding of drug
development or risk/benefit
balancing in a clinical
setting.
(V) Other expertise which the
Secretary deems necessary to
fulfill the activities under
this paragraph.
(G) Contract requirements.--Each contract
with a qualified entity under subparagraph
(F)(i) shall contain the following
requirements:
(i) Ensuring privacy.--The qualified
entity shall ensure that the entity
will not use data under this subsection
in a manner that--
(I) violates the regulations
promulgated under section
264(c) of the Health Insurance
Portability and Accountability
Act of 1996;
(II) violates sections 552 or
552a of title 5, United States
Code, with regard to the
privacy of individually-
identifiable beneficiary health
information; or
(III) discloses individually
identifiable health information
when presenting drug safety
signals and trends or when
responding to inquiries
regarding drug safety signals
and trends.
Nothing in this clause prohibits lawful
disclosure for other purposes.
(ii) Component of another
organization.--If a qualified entity is
a component of another organization--
(I) the qualified entity
shall establish appropriate
security measures to maintain
the confidentiality and privacy
of such data; and
(II) the entity shall not
make an unauthorized disclosure
of such data to the other
components of the organization
in breach of such
confidentiality and privacy
requirement.
(iii) Termination or nonrenewal.--If
a contract with a qualified entity
under this subparagraph is terminated
or not renewed, the following
requirements shall apply:
(I) Confidentiality and
privacy protections.--The
entity shall continue to comply
with the confidentiality and
privacy requirements under this
paragraph with respect to all
data disclosed to the entity.
(II) Disposition of data.--
The entity shall return any
data disclosed to such entity
under this subsection to which
it would not otherwise have
access or, if returning the
data is not practicable,
destroy the data.
(H) Competitive procedures.--The Secretary
shall use competitive procedures (as defined in
section 4(5) of the Federal Procurement Policy
Act) to enter into contracts under subparagraph
(G).
(I) Review of contract in the event of a
merger or acquisition.--The Secretary shall
review the contract with a qualified entity
under this paragraph in the event of a merger
or acquisition of the entity in order to ensure
that the requirements under this paragraph will
continue to be met.
(J) Coordination.--In carrying out this
paragraph, the Secretary shall provide for
appropriate communications to the public,
scientific, public health, and medical
communities, and other key stakeholders, and to
the extent practicable shall coordinate with
the activities of private entities,
professional associations, or other entities
that may have sources of drug safety data.
(5) The Secretary shall--
(A) conduct regular screenings of the Adverse
Event Reporting System database and post a
quarterly report on the Adverse Event Reporting
System Web site of any new safety information
or potential signal of a serious risk
identified by Adverse Event Reporting System
within the last quarter; and
(B) on an annual basis, review the entire
backlog of postmarket safety commitments to
determine which commitments require revision or
should be eliminated, report to the Congress on
these determinations, and assign start dates
and estimated completion dates for such
commitments; and
(C) make available on the Internet website of the
Food and Drug Administration--
(i) guidelines, developed with input from
experts qualified by scientific training and
experience to evaluate the safety and
effectiveness of drugs, that detail best
practices for drug safety surveillance using
the Adverse Event Reporting System; and
(ii) criteria for public posting of adverse
event signals.
(l)(1) Safety and effectiveness data and information which
has been submitted in an application under subsection (b) for a
drug and which has not previously been disclosed to the public
shall be made available to the public, upon request, unless
extraordinary circumstances are shown--
(A) if no work is being or will be undertaken to have
the application approved,
(B) if the Secretary has determined that the
application is not approvable and all legal appeals
have been exhausted,
(C) if approval of the application under subsection
(c) is withdrawn and all legal appeals have been
exhausted,
(D) if the Secretary has determined that such drug is
not a new drug, or
(E) upon the effective date of the approval of the
first application under subsection (j) which refers to
such drug or upon the date upon which the approval of
an application under subsection (j) which refers to
such drug could be made effective if such an
application had been submitted.
(2) Action Package for Approval.--
(A) Action package.--The Secretary shall publish the
action package for approval of an application under
subsection (b) or section 351 of the Public Health
Service Act on the Internet Web site of the Food and
Drug Administration--
(i) not later than 30 days after the date of
approval of such application for a drug no
active ingredient (including any ester or salt
of the active ingredient) of which has been
approved in any other application under this
section or section 351 of the Public Health
Service Act; and
(ii) not later than 30 days after the third
request for such action package for approval
received under section 552 of title 5, United
States Code, for any other drug.
(B) Immediate publication of summary review.--
Notwithstanding subparagraph (A), the Secretary shall
publish, on the Internet Web site of the Food and Drug
Administration, the materials described in subparagraph
(C)(iv) not later than 48 hours after the date of
approval of the drug, except where such materials
require redaction by the Secretary.
(C) Contents.--An action package for approval of an
application under subparagraph (A) shall be dated and
shall include the following:
(i) Documents generated by the Food and Drug
Administration related to review of the
application.
(ii) Documents pertaining to the format and
content of the application generated during
drug development.
(iii) Labeling submitted by the applicant.
(iv) A summary review that documents
conclusions from all reviewing disciplines
about the drug, noting any critical issues and
disagreements with the applicant and within the
review team and how they were resolved,
recommendations for action, and an explanation
of any nonconcurrence with review conclusions.
(v) The Division Director and Office
Director's decision document which includes--
(I) a brief statement of concurrence
with the summary review;
(II) a separate review or addendum to
the review if disagreeing with the
summary review; and
(III) a separate review or addendum
to the review to add further analysis.
(vi) Identification by name of each officer
or employee of the Food and Drug Administration
who--
(I) participated in the decision to
approve the application; and
(II) consents to have his or her name
included in the package.
(D) Review.--A scientific review of an application is
considered the work of the reviewer and shall not be
altered by management or the reviewer once final.
(E) Confidential information.--This paragraph does
not authorize the disclosure of any trade secret,
confidential commercial or financial information, or
other matter listed in section 552(b) of title 5,
United States Code.
(m) For purposes of this section, the term ``patent'' means a
patent issued by the United States Patent and Trademark Office.
(n)(1) For the purpose of providing expert scientific advice
and recommendations to the Secretary regarding a clinical
investigation of a drug or the approval for marketing of a drug
under section 505 or section 351 of the Public Health Service
Act, the Secretary shall establish panels of experts or use
panels of experts established before the date of enactment of
the Food and Drug Administration Modernization Act of 1997, or
both.
(2) The Secretary may delegate the appointment and oversight
authority granted under section 1004 to a director of a center
or successor entity within the Food and Drug Administration.
(3) The Secretary shall make appointments to each panel
established under paragraph (1) so that each panel shall
consist of--
(A) members who are qualified by training and
experience to evaluate the safety and effectiveness of
the drugs to be referred to the panel and who, to the
extent feasible, possess skill and experience in the
development, manufacture, or utilization of such drugs;
(B) members with diverse expertise in such fields as
clinical and administrative medicine, pharmacy,
pharmacology, pharmacoeconomics, biological and
physical sciences, and other related professions;
(C) a representative of consumer interests, and a
representative of interests of the drug manufacturing
industry not directly affected by the matter to be
brought before the panel; and
(D) two or more members who are specialists or have
other expertise in the particular disease or condition
for which the drug under review is proposed to be
indicated.
Scientific, trade, and consumer organizations shall be afforded
an opportunity to nominate individuals for appointment to the
panels. No individual who is in the regular full-time employ of
the United States and engaged in the administration of this Act
may be a voting member of any panel. The Secretary shall
designate one of the members of each panel to serve as chairman
thereof.
(4) The Secretary shall, as appropriate, provide education
and training to each new panel member before such member
participates in a panel's activities, including education
regarding requirements under this Act and related regulations
of the Secretary, and the administrative processes and
procedures related to panel meetings.
(5) Panel members (other than officers or employees of the
United States), while attending meetings or conferences of a
panel or otherwise engaged in its business, shall be entitled
to receive compensation for each day so engaged, including
traveltime, at rates to be fixed by the Secretary, but not to
exceed the daily equivalent of the rate in effect for positions
classified above grade GS-15 of the General Schedule. While
serving away from their homes or regular places of business,
panel members may be allowed travel expenses (including per
diem in lieu of subsistence) as authorized by section 5703 of
title 5, United States Code, for persons in the Government
service employed intermittently.
(6) The Secretary shall ensure that scientific advisory
panels meet regularly and at appropriate intervals so that any
matter to be reviewed by such a panel can be presented to the
panel not more than 60 days after the matter is ready for such
review. Meetings of the panel may be held using electronic
communication to convene the meetings.
(7) Within 90 days after a scientific advisory panel makes
recommendations on any matter under its review, the Food and
Drug Administration official responsible for the matter shall
review the conclusions and recommendations of the panel, and
notify the affected persons of the final decision on the
matter, or of the reasons that no such decision has been
reached. Each such final decision shall be documented including
the rationale for the decision.
(o) Postmarket Studies and Clinical Trials; Labeling.--
(1) In general.--A responsible person may not
introduce or deliver for introduction into interstate
commerce the new drug involved if the person is in
violation of a requirement established under paragraph
(3) or (4) with respect to the drug.
(2) Definitions.--For purposes of this subsection:
(A) Responsible person.--The term
``responsible person'' means a person who--
(i) has submitted to the Secretary a
covered application that is pending; or
(ii) is the holder of an approved
covered application.
(B) Covered application.--The term ``covered
application'' means--
(i) an application under subsection
(b) for a drug that is subject to
section 503(b); and
(ii) an application under section 351
of the Public Health Service Act.
(C) New safety information; serious risk.--
The terms ``new safety information'', ``serious
risk'', and ``signal of a serious risk'' have
the meanings given such terms in section 505-
1(b).
(3) Studies and clinical trials.--
(A) In general.--For any or all of the
purposes specified in subparagraph (B), the
Secretary may, subject to subparagraph (D),
require a responsible person for a drug to
conduct a postapproval study or studies of the
drug, or a postapproval clinical trial or
trials of the drug, on the basis of scientific
data deemed appropriate by the Secretary,
including information regarding chemically-
related or pharmacologically-related drugs.
(B) Purposes of study or clinical trial.--The
purposes referred to in this subparagraph with
respect to a postapproval study or postapproval
clinical trial are the following:
(i) To assess a known serious risk
related to the use of the drug
involved.
(ii) To assess signals of serious
risk related to the use of the drug.
(iii) To identify an unexpected
serious risk when available data
indicates the potential for a serious
risk.
(C) Establishment of requirement after
approval of covered application.--The Secretary
may require a postapproval study or studies or
postapproval clinical trial or trials for a
drug for which an approved covered application
is in effect as of the date on which the
Secretary seeks to establish such requirement
only if the Secretary becomes aware of new
safety information.
(D) Determination by secretary.--
(i) Postapproval studies.--The
Secretary may not require the
responsible person to conduct a study
under this paragraph, unless the
Secretary makes a determination that
the reports under subsection (k)(1) and
the active postmarket risk
identification and analysis system as
available under subsection (k)(3) will
not be sufficient to meet the purposes
set forth in subparagraph (B).
(ii) Postapproval clinical trials.--
The Secretary may not require the
responsible person to conduct a
clinical trial under this paragraph,
unless the Secretary makes a
determination that a postapproval study
or studies will not be sufficient to
meet the purposes set forth in
subparagraph (B).
(E) Notification; timetables; periodic
reports.--
(i) Notification.--The Secretary
shall notify the responsible person
regarding a requirement under this
paragraph to conduct a postapproval
study or clinical trial by the target
dates for communication of feedback
from the review team to the responsible
person regarding proposed labeling and
postmarketing study commitments as set
forth in the letters described in
section 101(c) of the Food and Drug
Administration Amendments Act of 2007.
(ii) Timetable; periodic reports.--
For each study or clinical trial
required to be conducted under this
paragraph, the Secretary shall require
that the responsible person submit a
timetable for completion of the study
or clinical trial. With respect to each
study required to be conducted under
this paragraph or otherwise undertaken
by the responsible person to
investigate a safety issue, the
Secretary shall require the responsible
person to periodically report to the
Secretary on the status of such study
including whether any difficulties in
completing the study have been
encountered. With respect to each
clinical trial required to be conducted
under this paragraph or otherwise
undertaken by the responsible person to
investigate a safety issue, the
Secretary shall require the responsible
person to periodically report to the
Secretary on the status of such
clinical trial including whether
enrollment has begun, the number of
participants enrolled, the expected
completion date, whether any
difficulties completing the clinical
trial have been encountered, and
registration information with respect
to the requirements under section
402(j) of the Public Health Service
Act. If the responsible person fails to
comply with such timetable or violates
any other requirement of this
subparagraph, the responsible person
shall be considered in violation of
this subsection, unless the responsible
person demonstrates good cause for such
noncompliance or such other violation.
The Secretary shall determine what
constitutes good cause under the
preceding sentence.
(F) Dispute resolution.--The responsible
person may appeal a requirement to conduct a
study or clinical trial under this paragraph
using dispute resolution procedures established
by the Secretary in regulation and guidance.
(4) Safety labeling changes requested by secretary.--
(A) New safety information.--If the Secretary
becomes aware of new safety information that
the Secretary believes should be included in
the labeling of the drug, the Secretary shall
promptly notify the responsible person or, if
the same drug approved under section 505(b) is
not currently marketed, the holder of an
approved application under 505(j).
(B) Response to notification.--Following
notification pursuant to subparagraph (A), the
responsible person or the holder of the
approved application under section 505(j) shall
within 30 days--
(i) submit a supplement proposing
changes to the approved labeling to
reflect the new safety information,
including changes to boxed warnings,
contraindications, warnings,
precautions, or adverse reactions; or
(ii) notify the Secretary that the
responsible person or the holder of the
approved application under section
505(j) does not believe a labeling
change is warranted and submit a
statement detailing the reasons why
such a change is not warranted.
(C) Review.--Upon receipt of such supplement,
the Secretary shall promptly review and act
upon such supplement. If the Secretary
disagrees with the proposed changes in the
supplement or with the statement setting forth
the reasons why no labeling change is
necessary, the Secretary shall initiate
discussions to reach agreement on whether the
labeling for the drug should be modified to
reflect the new safety information, and if so,
the contents of such labeling changes.
(D) Discussions.--Such discussions shall not
extend for more than 30 days after the response
to the notification under subparagraph (B),
unless the Secretary determines an extension of
such discussion period is warranted.
(E) Order.--Within 15 days of the conclusion
of the discussions under subparagraph (D), the
Secretary may issue an order directing the
responsible person or the holder of the
approved application under section 505(j) to
make such a labeling change as the Secretary
deems appropriate to address the new safety
information. Within 15 days of such an order,
the responsible person or the holder of the
approved application under section 505(j) shall
submit a supplement containing the labeling
change.
(F) Dispute resolution.--Within 5 days of
receiving an order under subparagraph (E), the
responsible person or the holder of the
approved application under section 505(j) may
appeal using dispute resolution procedures
established by the Secretary in regulation and
guidance.
(G) Violation.--If the responsible person or
the holder of the approved application under
section 505(j) has not submitted a supplement
within 15 days of the date of such order under
subparagraph (E), and there is no appeal or
dispute resolution proceeding pending, the
responsible person or holder shall be
considered to be in violation of this
subsection. If at the conclusion of any dispute
resolution procedures the Secretary determines
that a supplement must be submitted and such a
supplement is not submitted within 15 days of
the date of that determination, the responsible
person or holder shall be in violation of this
subsection.
(H) Public health threat.--Notwithstanding
subparagraphs (A) through (F), if the Secretary
concludes that such a labeling change is
necessary to protect the public health, the
Secretary may accelerate the timelines in such
subparagraphs.
(I) Rule of construction.--This paragraph
shall not be construed to affect the
responsibility of the responsible person or the
holder of the approved application under
section 505(j) to maintain its label in
accordance with existing requirements,
including subpart B of part 201 and sections
314.70 and 601.12 of title 21, Code of Federal
Regulations (or any successor regulations).
(5) Non-delegation.--Determinations by the Secretary
under this subsection for a drug shall be made by
individuals at or above the level of individuals
empowered to approve a drug (such as division directors
within the Center for Drug Evaluation and Research).
(p) Risk Evaluation and Mitigation Strategy.--
(1) In general.--A person may not introduce or
deliver for introduction into interstate commerce a new
drug if--
(A)(i) the application for such drug is
approved under subsection (b) or (j) and is
subject to section 503(b); or
(ii) the application for such drug is
approved under section 351 of the Public Health
Service Act; and
(B) a risk evaluation and mitigation strategy
is required under section 505-1 with respect to
the drug and the person fails to maintain
compliance with the requirements of the
approved strategy or with other requirements
under section 505-1, including requirements
regarding assessments of approved strategies.
(2) Certain postmarket studies.--The failure to
conduct a postmarket study under section 506, subpart H
of part 314, or subpart E of part 601 of title 21, Code
of Federal Regulations (or any successor regulations),
is deemed to be a violation of paragraph (1).
(q) Petitions and Civil Actions Regarding Approval of Certain
Applications.--
(1) In general.--
(A) Determination.--The Secretary shall not
delay approval of a pending application
submitted under subsection (b)(2) or (j) of
this section or section 351(k) of the Public
Health Service Act because of any request to
take any form of action relating to the
application, either before or during
consideration of the request, unless--
(i) the request is in writing and is
a petition submitted to the Secretary
pursuant to section 10.30 or 10.35 of
title 21, Code of Federal Regulations
(or any successor regulations); and
(ii) the Secretary determines, upon
reviewing the petition, that a delay is
necessary to protect the public health.
Consideration of the petition shall be separate
and apart from review and approval of any
application.
(B) Notification.--If the Secretary
determines under subparagraph (A) that a delay
is necessary with respect to an application,
the Secretary shall provide to the applicant,
not later than 30 days after making such
determination, the following information:
(i) Notification of the fact that a
determination under subparagraph (A)
has been made.
(ii) If applicable, any clarification
or additional data that the applicant
should submit to the docket on the
petition to allow the Secretary to
review the petition promptly.
(iii) A brief summary of the specific
substantive issues raised in the
petition which form the basis of the
determination.
(C) Format.--The information described in
subparagraph (B) shall be conveyed via either,
at the discretion of the Secretary--
(i) a document; or
(ii) a meeting with the applicant
involved.
(D) Public disclosure.--Any information
conveyed by the Secretary under subparagraph
(C) shall be considered part of the application
and shall be subject to the disclosure
requirements applicable to information in such
application.
(E) Denial based on intent to delay.--If the
Secretary determines that a petition or a
supplement to the petition was submitted with
the primary purpose of delaying the approval of
an application and the petition does not on its
face raise valid scientific or regulatory
issues, the Secretary may deny the petition at
any point based on such determination. The
Secretary may issue guidance to describe the
factors that will be used to determine under
this subparagraph whether a petition is
submitted with the primary purpose of delaying
the approval of an application.
(F) Final agency action.--The Secretary shall
take final agency action on a petition not
later than 150 days after the date on which the
petition is submitted. The Secretary shall not
extend such period for any reason, including--
(i) any determination made under
subparagraph (A);
(ii) the submission of comments
relating to the petition or
supplemental information supplied by
the petitioner; or
(iii) the consent of the petitioner.
(G) Extension of 30-month period.--If the
filing of an application resulted in first-
applicant status under subsection
(j)(5)(D)(i)(IV) and approval of the
application was delayed because of a petition,
the 30-month period under such subsection is
deemed to be extended by a period of time equal
to the period beginning on the date on which
the Secretary received the petition and ending
on the date of final agency action on the
petition (inclusive of such beginning and
ending dates), without regard to whether the
Secretary grants, in whole or in part, or
denies, in whole or in part, the petition.
(H) Certification.--The Secretary shall not
consider a petition for review unless the party
submitting such petition does so in written
form and the subject document is signed and
contains the following certification: ``I
certify that, to my best knowledge and belief:
(a) this petition includes all information and
views upon which the petition relies; (b) this
petition includes representative data and/or
information known to the petitioner which are
unfavorable to the petition; and (c) I have
taken reasonable steps to ensure that any
representative data and/or information which
are unfavorable to the petition were disclosed
to me. I further certify that the information
upon which I have based the action requested
herein first became known to the party on whose
behalf this petition is submitted on or about
the following date: __________. If I received
or expect to receive payments, including cash
and other forms of consideration, to file this
information or its contents, I received or
expect to receive those payments from the
following persons or organizations:
_____________. I verify under penalty of
perjury that the foregoing is true and correct
as of the date of the submission of this
petition.'', with the date on which such
information first became known to such party
and the names of such persons or organizations
inserted in the first and second blank space,
respectively.
(I) Verification.--The Secretary shall not
accept for review any supplemental information
or comments on a petition unless the party
submitting such information or comments does so
in written form and the subject document is
signed and contains the following verification:
``I certify that, to my best knowledge and
belief: (a) I have not intentionally delayed
submission of this document or its contents;
and (b) the information upon which I have based
the action requested herein first became known
to me on or about __________. If I received or
expect to receive payments, including cash and
other forms of consideration, to file this
information or its contents, I received or
expect to receive those payments from the
following persons or organizations: _____. I
verify under penalty of perjury that the
foregoing is true and correct as of the date of
the submission of this petition.'', with the
date on which such information first became
known to the party and the names of such
persons or organizations inserted in the first
and second blank space, respectively.
(2) Exhaustion of administrative remedies.--
(A) Final agency action within 150 days.--The
Secretary shall be considered to have taken
final agency action on a petition if--
(i) during the 150-day period
referred to in paragraph (1)(F), the
Secretary makes a final decision within
the meaning of section 10.45(d) of
title 21, Code of Federal Regulations
(or any successor regulation); or
(ii) such period expires without the
Secretary having made such a final
decision.
(B) Dismissal of certain civil actions.--If a
civil action is filed against the Secretary
with respect to any issue raised in the
petition before the Secretary has taken final
agency action on the petition within the
meaning of subparagraph (A), the court shall
dismiss without prejudice the action for
failure to exhaust administrative remedies.
(C) Administrative record.--For purposes of
judicial review related to the approval of an
application for which a petition under
paragraph (1) was submitted, the administrative
record regarding any issue raised by the
petition shall include--
(i) the petition filed under
paragraph (1) and any supplements and
comments thereto;
(ii) the Secretary's response to such
petition, if issued; and
(iii) other information, as
designated by the Secretary, related to
the Secretary's determinations
regarding the issues raised in such
petition, as long as the information
was considered by the agency no later
than the date of final agency action as
defined under subparagraph (2)(A), and
regardless of whether the Secretary
responded to the petition at or before
the approval of the application at
issue in the petition.
(3) Annual report on delays in approvals per
petitions.--The Secretary shall annually submit to the
Congress a report that specifies--
(A) the number of applications that were
approved during the preceding 12-month period;
(B) the number of such applications whose
effective dates were delayed by petitions
referred to in paragraph (1) during such
period;
(C) the number of days by which such
applications were so delayed; and
(D) the number of such petitions that were
submitted during such period.
(4) Exceptions.--
(A) This subsection does not apply to--
(i) a petition that relates solely to
the timing of the approval of an
application pursuant to subsection
(j)(5)(B)(iv); or
(ii) a petition that is made by the
sponsor of an application and that
seeks only to have the Secretary take
or refrain from taking any form of
action with respect to that
application.
(B) Paragraph (2) does not apply to a
petition addressing issues concerning an
application submitted pursuant to section
351(k) of the Public Health Service Act.
(5) Definitions.--
(A) Application.--For purposes of this
subsection, the term ``application'' means an
application submitted under subsection (b)(2)
or (j) of this section or section 351(k) of the
Public Health Service Act.
(B) Petition.--For purposes of this
subsection, other than paragraph (1)(A)(i), the
term ``petition'' means a request described in
paragraph (1)(A)(i).
(r) Postmarket Drug Safety Information for Patients and
Providers.--
(1) Establishment.--Not later than 1 year after the
date of the enactment of the Food and Drug
Administration Amendments Act of 2007, the Secretary
shall improve the transparency of information about
drugs and allow patients and health care providers
better access to information about drugs by developing
and maintaining an Internet Web site that--
(A) provides links to drug safety information
listed in paragraph (2) for prescription drugs
that are approved under this section or
licensed under section 351 of the Public Health
Service Act; and
(B) improves communication of drug safety
information to patients and providers.
(2) Internet web site.--The Secretary shall carry out
paragraph (1) by--
(A) developing and maintaining an accessible,
consolidated Internet Web site with easily
searchable drug safety information, including
the information found on United States
Government Internet Web sites, such as the
United States National Library of Medicine's
Daily Med and Medline Plus Web sites, in
addition to other such Web sites maintained by
the Secretary;
(B) ensuring that the information provided on
the Internet Web site is comprehensive and
includes, when available and appropriate--
(i) patient labeling and patient
packaging inserts;
(ii) a link to a list of each drug,
whether approved under this section or
licensed under such section 351, for
which a Medication Guide, as provided
for under part 208 of title 21, Code of
Federal Regulations (or any successor
regulations), is required;
(iii) a link to the registry and
results data bank provided for under
subsections (i) and (j) of section 402
of the Public Health Service Act;
(iv) the most recent safety
information and alerts issued by the
Food and Drug Administration for drugs
approved by the Secretary under this
section, such as product recalls,
warning letters, and import alerts;
(v) publicly available information
about implemented RiskMAPs and risk
evaluation and mitigation strategies
under subsection (o);
(vi) guidance documents and
regulations related to drug safety; and
(vii) other material determined
appropriate by the Secretary;
(C) providing access to summaries of the
assessed and aggregated data collected from the
active surveillance infrastructure under
subsection (k)(3) to provide information of
known and serious side-effects for drugs
approved under this section or licensed under
such section 351;
(D) preparing and making publicly available
on the Internet website established under
paragraph (1) best practices for drug safety
surveillance activities for drugs approved
under this section or section 351 of the Public
Health Service Act;
(E) enabling patients, providers, and drug
sponsors to submit adverse event reports
through the Internet Web site;
(F) providing educational materials for
patients and providers about the appropriate
means of disposing of expired, damaged, or
unusable medications; and
(G) supporting initiatives that the Secretary
determines to be useful to fulfill the purposes
of the Internet Web site.
(3) Posting of drug labeling.--The Secretary shall
post on the Internet Web site established under
paragraph (1) the approved professional labeling and
any required patient labeling of a drug approved under
this section or licensed under such section 351 not
later than 21 days after the date the drug is approved
or licensed, including in a supplemental application
with respect to a labeling change.
(4) Private sector resources.--To ensure development
of the Internet Web site by the date described in
paragraph (1), the Secretary may, on a temporary or
permanent basis, implement systems or products
developed by private entities.
(5) Authority for contracts.--The Secretary may enter
into contracts with public and private entities to
fulfill the requirements of this subsection.
(6) Review.--The Advisory Committee on Risk
Communication under section 567 shall, on a regular
basis, perform a comprehensive review and evaluation of
the types of risk communication information provided on
the Internet Web site established under paragraph (1)
and, through other means, shall identify, clarify, and
define the purposes and types of information available
to facilitate the efficient flow of information to
patients and providers, and shall recommend ways for
the Food and Drug Administration to work with outside
entities to help facilitate the dispensing of risk
communication information to patients and providers.
(s) Referral to Advisory Committee.--Prior to the approval of
a drug no active ingredient (including any ester or salt of the
active ingredient) of which has been approved in any other
application under this section or section 351 of the Public
Health Service Act, the Secretary shall--
(1) refer such drug to a Food and Drug Administration
advisory committee for review at a meeting of such
advisory committee; or
(2) if the Secretary does not refer such a drug to a
Food and Drug Administration advisory committee prior
to the approval of the drug, provide in the action
letter on the application for the drug a summary of the
reasons why the Secretary did not refer the drug to an
advisory committee prior to approval.
(t) Database for Authorized Generic Drugs.--
(1) In general.--
(A) Publication.--The Commissioner shall--
(i) not later than 9 months after the
date of the enactment of the Food and
Drug Administration Amendments Act of
2007, publish a complete list on the
Internet Web site of the Food and Drug
Administration of all authorized
generic drugs (including drug trade
name, brand company manufacturer, and
the date the authorized generic drug
entered the market); and
(ii) update the list quarterly to
include each authorized generic drug
included in an annual report submitted
to the Secretary by the sponsor of a
listed drug during the preceding 3-
month period.
(B) Notification.--The Commissioner shall
notify relevant Federal agencies, including the
Centers for Medicare & Medicaid Services and
the Federal Trade Commission, when the
Commissioner first publishes the information
described in subparagraph (A) that the
information has been published and that the
information will be updated quarterly.
(2) Inclusion.--The Commissioner shall include in the
list described in paragraph (1) each authorized generic
drug included in an annual report submitted to the
Secretary by the sponsor of a listed drug after January
1, 1999.
(3) Authorized generic drug.--In this section, the
term ``authorized generic drug'' means a listed drug
(as that term is used in subsection (j)) that--
(A) has been approved under subsection (c);
and
(B) is marketed, sold, or distributed
directly or indirectly to retail class of trade
under a different labeling, packaging (other
than repackaging as the listed drug in blister
packs, unit doses, or similar packaging for use
in institutions), product code, labeler code,
trade name, or trade mark than the listed drug.
(u) Certain Drugs Containing Single Enantiomers.--
(1) In general.--For purposes of subsections
(c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is
submitted under subsection (b) for a non-racemic drug
containing as an active ingredient (including any ester
or salt of the active ingredient) a single enantiomer
that is contained in a racemic drug approved in another
application under subsection (b), the applicant may, in
the application for such non-racemic drug, elect to
have the single enantiomer not be considered the same
active ingredient as that contained in the approved
racemic drug, if--
(A)(i) the single enantiomer has not been
previously approved except in the approved
racemic drug; and
(ii) the application submitted under
subsection (b) for such non-racemic drug--
(I) includes full reports of new
clinical investigations (other than
bioavailability studies)--
(aa) necessary for the
approval of the application
under subsections (c) and (d);
and
(bb) conducted or sponsored
by the applicant; and
(II) does not rely on any clinical
investigations that are part of an
application submitted under subsection
(b) for approval of the approved
racemic drug; and
(B) the application submitted under
subsection (b) for such non-racemic drug is not
submitted for approval of a condition of use--
(i) in a therapeutic category in
which the approved racemic drug has
been approved; or
(ii) for which any other enantiomer
of the racemic drug has been approved.
(2) Limitation.--
(A) No approval in certain therapeutic
categories.--Until the date that is 10 years
after the date of approval of a non-racemic
drug described in paragraph (1) and with
respect to which the applicant has made the
election provided for by such paragraph, the
Secretary shall not approve such non-racemic
drug for any condition of use in the
therapeutic category in which the racemic drug
has been approved.
(B) Labeling.--If applicable, the labeling of
a non-racemic drug described in paragraph (1)
and with respect to which the applicant has
made the election provided for by such
paragraph shall include a statement that the
non-racemic drug is not approved, and has not
been shown to be safe and effective, for any
condition of use of the racemic drug.
(3) Definition.--
(A) In general.--For purposes of this
subsection, the term ``therapeutic category''
means a therapeutic category identified in the
list developed by the United States
Pharmacopeia pursuant to section 1860D-
4(b)(3)(C)(ii) of the Social Security Act and
as in effect on the date of the enactment of
this subsection.
(B) Publication by secretary.--The Secretary
shall publish the list described in
subparagraph (A) and may amend such list by
regulation.
(4) Availability.--The election referred to in
paragraph (1) may be made only in an application that
is submitted to the Secretary after the date of the
enactment of this subsection and before October 1,
[2017] 2022.
(v) Antibiotic Drugs Submitted Before November 21, 1997.--
(1) Antibiotic drugs approved before november 21,
1997.--
(A) In general.--Notwithstanding any
provision of the Food and Drug Administration
Modernization Act of 1997 or any other
provision of law, a sponsor of a drug that is
the subject of an application described in
subparagraph (B)(i) shall be eligible for, with
respect to the drug, the 3-year exclusivity
period referred to under clauses (iii) and (iv)
of subsection (c)(3)(E) and under clauses (iii)
and (iv) of subsection (j)(5)(F), subject to
the requirements of such clauses, as
applicable.
(B) Application; antibiotic drug described.--
(i) Application.--An application
described in this clause is an
application for marketing submitted
under this section after the date of
the enactment of this subsection in
which the drug that is the subject of
the application contains an antibiotic
drug described in clause (ii).
(ii) Antibiotic drug.--An antibiotic
drug described in this clause is an
antibiotic drug that was the subject of
an application approved by the
Secretary under section 507 of this Act
(as in effect before November 21,
1997).
(2) Antibiotic drugs submitted before november 21,
1997, but not approved.--
(A) In general.--Notwithstanding any
provision of the Food and Drug Administration
Modernization Act of 1997 or any other
provision of law, a sponsor of a drug that is
the subject of an application described in
subparagraph (B)(i) may elect to be eligible
for, with respect to the drug--
(i)(I) the 3-year exclusivity period
referred to under clauses (iii) and
(iv) of subsection (c)(3)(E) and under
clauses (iii) and (iv) of subsection
(j)(5)(F), subject to the requirements
of such clauses, as applicable; and
(II) the 5-year exclusivity period
referred to under clause (ii) of
subsection (c)(3)(E) and under clause
(ii) of subsection (j)(5)(F), subject
to the requirements of such clauses, as
applicable; or
(ii) a patent term extension under
section 156 of title 35, United States
Code, subject to the requirements of
such section.
(B) Application; antibiotic drug described.--
(i) Application.--An application
described in this clause is an
application for marketing submitted
under this section after the date of
the enactment of this subsection in
which the drug that is the subject of
the application contains an antibiotic
drug described in clause (ii).
(ii) Antibiotic drug.--An antibiotic
drug described in this clause is an
antibiotic drug that was the subject of
1 or more applications received by the
Secretary under section 507 of this Act
(as in effect before November 21,
1997), none of which was approved by
the Secretary under such section.
(3) Limitations.--
(A) Exclusivities and extensions.--Paragraphs
(1)(A) and (2)(A) shall not be construed to
entitle a drug that is the subject of an
approved application described in subparagraphs
(1)(B)(i) or (2)(B)(i), as applicable, to any
market exclusivities or patent extensions other
than those exclusivities or extensions
described in paragraph (1)(A) or (2)(A).
(B) Conditions of use.--Paragraphs (1)(A) and
(2)(A)(i) shall not apply to any condition of
use for which the drug referred to in
subparagraph (1)(B)(i) or (2)(B)(i), as
applicable, was approved before the date of the
enactment of this subsection.
(4) Application of certain provisions.--
Notwithstanding section 125, or any other provision, of
the Food and Drug Administration Modernization Act of
1997, or any other provision of law, and subject to the
limitations in paragraphs (1), (2), and (3), the
provisions of the Drug Price Competition and Patent
Term Restoration Act of 1984 shall apply to any drug
subject to paragraph (1) or any drug with respect to
which an election is made under paragraph (2)(A).
(w) Deadline for Determination on Certain Petitions.--The
Secretary shall issue a final, substantive determination on a
petition submitted pursuant to subsection (b) of section
314.161 of title 21, Code of Federal Regulations (or any
successor regulations), no later than 270 days after the date
the petition is submitted.
(x) Date of Approval in the Case of Recommended Controls
Under the CSA.--
(1) In general.--In the case of an application under
subsection (b) with respect to a drug for which the
Secretary provides notice to the sponsor that the
Secretary intends to issue a scientific and medical
evaluation and recommend controls under the Controlled
Substances Act, approval of such application shall not
take effect until the interim final rule controlling
the drug is issued in accordance with section 201(j) of
the Controlled Substances Act.
(2) Date of approval.--For purposes of this section,
with respect to an application described in paragraph
(1), the term ``date of approval'' shall mean the later
of--
(A) the date an application under subsection
(b) is approved under subsection (c); or
(B) the date of issuance of the interim final
rule controlling the drug.
(y) Contrast Agents Intended for Use With Applicable Medical
Imaging Devices.--
(1) The sponsor of a contrast agent for which an
application has been approved under this section may
submit a supplement to the application seeking approval
for the use of the contrast agent for a new indication
and conditions of use following the authorization of a
premarket submission for an applicable medical imaging
device for that use with the contrast agent pursuant to
section 520(q)(1).
(2) In reviewing a supplement submitted under this
subsection, the agency center charged with the
premarket review of drugs may--
(A) consult with the center charged with the
premarket review of devices; and
(B) review information and data submitted to
the Secretary by the sponsor of an applicable
medical imaging device pursuant to section 515,
510(k), or 513(f)(2) so long as the sponsor of
such applicable medical imaging device has
provided to the sponsor of the contrast agent a
right of reference.
(3) For purposes of this subsection--
(A) the term ``new indication'' means a use
of a contrast agent that is described in the
approved labeling of an applicable medical
imaging device described in section 520(q), but
that is not described in the approved labeling
of the contrast agent; and
(B) the term ``applicable medical imaging
device'' and ``contrast agent'' have the
meanings given such terms in section 520(q).
* * * * * * *
SEC. 505F. UTILIZING REAL WORLD EVIDENCE.
(a) In General.--The Secretary shall establish a program to
evaluate the potential use of real world evidence--
(1) to help to support the approval of a new
indication for a drug approved under section 505(c);
and
(2) to help to support or satisfy postapproval study
requirements.
(b) Real World Evidence Defined.--In this section, the term
``real world evidence'' means data regarding the usage, or the
potential benefits or risks, of a drug derived from sources
other than [randomized] traditional clinical trials.
(c) Program Framework.--
(1) In general.--Not later than 2 years after the
date of enactment of the 21st Century Cures Act, the
Secretary shall establish a draft framework for
implementation of the program under this section.
(2) Contents of framework.--The framework shall
include information describing--
(A) the sources of real world evidence,
including ongoing safety surveillance,
observational studies, registries, claims, and
patient-centered outcomes research activities;
(B) the gaps in data collection activities;
(C) the standards and methodologies for
collection and analysis of real world evidence;
and
(D) the priority areas, remaining challenges,
and potential pilot opportunities that the
program established under this section will
address.
(3) Consultation.--
(A) In general.--In developing the program
framework under this subsection, the Secretary
shall consult with regulated industry,
academia, medical professional organizations,
representatives of patient advocacy
organizations, consumer organizations, disease
research foundations, and other interested
parties.
(B) Process.--The consultation under
subparagraph (A) may be carried out through
approaches such as--
(i) a public-private partnership with
the entities described in such
subparagraph in which the Secretary may
participate;
(ii) a contract, grant, or other
arrangement, as the Secretary
determines appropriate, with such a
partnership or an independent research
organization; or
(iii) public workshops with the
entities described in such
subparagraph.
(d) Program Implementation.--The Secretary shall, not later
than [2] 3 years after the date of enactment of the 21st
Century Cures Act and in accordance with the framework
established under subsection (c), implement the program to
evaluate the potential use of real world evidence.
(e) Guidance for Industry.--The Secretary shall--
(1) utilize the program established under subsection
(a), its activities, and any subsequent pilots or
written reports, to inform a guidance for industry on--
(A) the circumstances under which sponsors of
drugs and the Secretary may rely on real world
evidence for the purposes described in
paragraphs (1) and (2) of subsection (a); and
(B) the appropriate standards and
methodologies for collection and analysis of
real world evidence submitted for such
purposes;
(2) not later than 5 years after the date of
enactment of the 21st Century Cures Act, issue draft
guidance for industry as described in paragraph (1);
and
(3) not later than 18 months after the close of the
public comment period for the draft guidance described
in paragraph (2), issue revised draft guidance or final
guidance.
(f) Rule of Construction.--
(1) In general.--Subject to paragraph (2), nothing in
this section prohibits the Secretary from using real
world evidence for purposes not specified in this
section, provided the Secretary determines that
sufficient basis exists for any such nonspecified use.
(2) Standards of evidence and secretary's
authority.--This section shall not be construed to
alter--
(A) the standards of evidence under--
(i) subsection (c) or (d) of section
505, including the substantial evidence
standard in such subsection (d); or
(ii) section 351(a) of the Public
Health Service Act; or
(B) the Secretary's authority to require
postapproval studies or clinical trials, or the
standards of evidence under which studies or
trials are evaluated.
* * * * * * *
SEC. 506G. STANDARDS FOR REGENERATIVE MEDICINE AND REGENERATIVE
ADVANCED THERAPIES.
(a) In General.--Not later than 2 years after the date of
enactment of the 21st Century Cures Act, the Secretary, in
consultation with the National Institute of Standards and
Technology and stakeholders (including regenerative medicine
and advanced therapies manufacturers and clinical trial
sponsors, contract manufacturers, academic institutions,
practicing clinicians, regenerative medicine and advanced
therapies industry organizations, and standard setting
organizations), shall facilitate an effort to coordinate and
prioritize the development of standards and consensus
definition of terms, through a public process, to support,
through regulatory predictability, the development, evaluation,
and review of regenerative medicine therapies and regenerative
advanced therapies, including with respect to the manufacturing
processes and controls of such products.
(b) Activities.--
(1) In general.--In carrying out this section, the
Secretary shall continue to--
(A) [identity] identify opportunities to help
advance the development of regenerative
medicine therapies and regenerative advanced
therapies;
(B) identify opportunities for the
development of laboratory regulatory science
research and documentary standards that the
Secretary determines would help support the
development, evaluation, and review of
regenerative medicine therapies and
regenerative advanced therapies through
regulatory predictability; and
(C) work with stakeholders, such as those
described in subsection (a), as appropriate, in
the development of such standards.
(2) Regulations and guidance.--Not later than 1 year
after the development of standards as described in
subsection (a), the Secretary shall review relevant
regulations and guidance and, through a public process,
update such regulations and guidance as the Secretary
determines appropriate.
(c) Definitions.--For purposes of this section, the terms
``regenerative medicine therapy'' and ``regenerative advanced
therapy'' have the meanings given such terms in section 506(g).
SEC. 506H. COMPETITIVE GENERIC THERAPIES.
(a) In General.--The Secretary shall, at the request of the
sponsor of a drug that is designated as a competitive generic
therapy pursuant to subsection (b), expedite the development
and review of such drug pursuant to section 505(j).
(b) Designation Process.--
(1) Request.--The sponsor of a drug may request the
Secretary to designate the drug as a competitive
generic therapy.
(2) Timing.--A request under paragraph (1) may be
made concurrently with, or at any time prior to, the
submission of an abbreviated new drug application for
the drug under section 505(j).
(3) Criteria.--A drug is eligible for designation as
a competitive generic therapy under this section if the
Secretary determines that there is inadequate generic
competition.
(4) Designation.--Not later than 60 calendar days
after the receipt of a request under paragraph (1), the
Secretary shall--
(A) determine whether the drug that is the
subject of the request meets the criteria
described in paragraph (3); and
(B) if the Secretary finds that the drug
meets such criteria, designate the drug as a
competitive generic therapy.
(c) Actions.--In expediting the development and review of a
drug under subsection (a), the Secretary shall, as requested by
the sponsor, take actions including the following:
(1) Hold meetings with the sponsor and the review
team throughout the development of the drug prior to
submission of the application for such drug under
section 505(j).
(2) Provide timely advice to, and interactive
communication with, the sponsor regarding the
development of the drug to ensure that the development
program to gather the data necessary for approval is as
efficient as practicable.
(3) Involve senior managers and experienced review
staff, as appropriate, in a collaborative, coordinated
review, including with respect to drug-device
combination products and other complex products.
(4) Assign a cross-disciplinary project lead for the
Food and Drug Administration review team--
(A) to facilitate an efficient review of the
development program and application, including
manufacturing inspections; and
(B) to serve as a scientific liaison between
the review team and the sponsor.
(d) Definitions.--In this section:
(1) The term ``generic drug'' means a drug that is
approved pursuant to section 505(j).
(2) The term ``inadequate generic competition''
means, with respect to a product, there is not more
than one approved drug product on the list of products
described in section 505(j)(7)(A) (not including
products on the discontinued section of such list) that
is--
(A) the reference listed drug; or
(B) a generic drug with the same reference
listed drug as the drug for which designation
as a competitive generic therapy is sought.
(3) The term ``reference listed drug'' means the
listed drug (as such term is used in section 505(j))
for the drug involved.
* * * * * * *
Sec. 510. (a) As used in this section--
(1) the term ``manufacture, preparation, propagation,
compounding, or processing'' shall include repackaging
or otherwise changing the container, wrapper, or
labeling of any drug package or device package in
furtherance of the distribution of the drug or device
from the original place of manufacture to the person
who makes final delivery or sale to the ultimate
consumer or user; and
(2) the term ``name'' shall include in the case of a
partnership the name of each partner and, in the case
of a corporation, the name of each corporate officer
and director, and the State of incorporation.
(b)(1) 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.
(2) 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
device or devices shall register with the Secretary his name,
places of business, and all such establishments.
(3) The Secretary shall specify the unique facility
identifier system that shall be used by registrants under
paragraph (1). The requirement to include a unique facility
identifier in a registration under paragraph (1) shall not
apply until the date that the identifier system is specified by
the Secretary under the preceding sentence.
(c) Every person upon first engaging in the manufacture,
preparation, propagation, compounding, or processing of a drug
or drugs or a device or devices in any establishment which he
owns or operates in any State shall immediately register with
the Secretary--
(1) with respect to drugs, the information described
under subsection (b)(1); and
(2) with respect to devices, the information
described under subsection (b)(2)..
(d) Every person duly registered in accordance with the
foregoing subsections of this section shall immediately
register with the Secretary any additional establishment which
he owns or operates in any State and in which he begins the
manufacture, preparation, propagation, compounding, or
processing of a drug or drugs or a device or devices.
(e) The Secretary may assign a registration number to any
person or any establishment registered in accordance with this
section. The Secretary may also assign a listing number to each
drug or class of drugs listed under subsection (j). Any number
assigned pursuant to the preceding sentence shall be the same
as that assigned pursuant to the National Drug Code. The
Secretary may by regulation prescribe a uniform system for the
identification of devices intended for human use and may
require that persons who are required to list such devices
pursuant to subsection (j) shall list such devices in
accordance with such system.
(f) The Secretary shall make available for inspection, to any
person so requesting, any registration filed pursuant to this
section; except that any list submitted pursuant to paragraph
(3) of subsection (j) and the information accompanying any list
or notice filed under paragraph (1) or (2) of that subsection
shall be exempt from such inspection unless the Secretary finds
that such an exemption would be inconsistent with protection of
the public health.
(g) The foregoing subsections of this section shall not apply
to--
(1) pharmacies which maintain establishments in
conformance with any applicable local laws regulating
the practice of pharmacy and medicine and which are
regularly engaged in dispensing prescription drugs or
devices, upon prescriptions of practitioners licensed
to administer such drugs or devices to patients under
the care of such practitioners in the course of their
professional practice, and which do not manufacture,
prepare, propagate, compound, or process drugs or
devices for sale other than in the regular course of
their business of dispensing or selling drugs or
devices at retail;
(2) practitioners licensed by law to prescribe or
administer drugs or devices and who manufacture,
prepare, propagate, compound, or process drugs or
devices solely for use in the course of their
professional practice;
(3) persons who manufacture, prepare, propagate,
compound, or process drugs or devices solely for use in
research, teaching, or chemical analysis and not for
sale;
(4) any distributor who acts as a wholesale
distributor of devices, and who does not manufacture,
repackage, process, or relabel a device; or
(5) such other classes of persons as the Secretary
may by regulation exempt from the application of this
section upon a finding that registration by such
classes of persons in accordance with this section is
not necessary for the protection of the public health.
In this subsection, the term ``wholesale distributor'' means
any person (other than the manufacturer or the initial
importer) who distributes a device from the original place of
manufacture to the person who makes the final delivery or sale
of the device to the ultimate consumer or user.
(h) Inspections.--
(1) In general.--Every establishment that is required
to be registered with the Secretary under this section
shall be subject to inspection pursuant to section 704.
[(2) Biennial inspections for devices.--Every
establishment described in paragraph (1), in any State,
that is engaged in the manufacture, propagation,
compounding, or processing of a device or devices
classified in class II or III shall be so inspected by
one or more officers or employees duly designated by
the Secretary, or by persons accredited to conduct
inspections under section 704(g), at least once in the
2-year period beginning with the date of registration
of such establishment pursuant to this section and at
least once in every successive 2-year period
thereafter.]
(2) Risk-based schedule for devices.--
(A) In general.--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, propagation,
compounding, or processing of a device or
devices (referred to in this subsection as
``device establishments'') in accordance with a
risk-based schedule established by the
Secretary.
(B) Factors and considerations.--In
establishing the risk-based schedule under
subparagraph (A), the Secretary shall--
(i) apply, to the extent applicable
for device establishments, the factors
identified in paragraph (4); and
(ii) consider the participation of
the device establishment, as
applicable, in international device
audit programs in which the United
States participates or which the United
States recognizes for purposes of
inspecting device establishments.
(3) Risk-based schedule for drugs.--The Secretary,
acting through one or more officers or employees duly
designated by the Secretary, shall inspect
establishments described in paragraph (1) that are
engaged in the manufacture, preparation, propagation,
compounding, or processing of a drug or drugs (referred
to in this subsection as ``drug establishments'') in
accordance with a risk-based schedule established by
the Secretary.
(4) Risk factors.--In establishing a risk-based
schedule under paragraph (3), the Secretary shall
inspect establishments according to the known safety
risks of such establishments, which shall be based on
the following factors:
(A) The compliance history of the
establishment.
(B) The record, history, and nature of
recalls linked to the establishment.
(C) The inherent risk of the drug
manufactured, prepared, propagated, compounded,
or processed at the establishment.
(D) The inspection frequency and history of
the establishment, including whether the
establishment has been inspected pursuant to
section 704 within the last 4 years.
(E) Whether the establishment has been
inspected by a foreign government or an agency
of a foreign government recognized under
section 809.
(F) Any other criteria deemed necessary and
appropriate by the Secretary for purposes of
allocating inspection resources.
(5) Effect of status.--In determining the risk
associated with an establishment for purposes of
establishing a risk-based schedule under paragraph (3),
the Secretary shall not consider whether the drugs
manufactured, prepared, propagated, compounded, or
processed by such establishment are drugs described in
section 503(b).
(6) Annual report on inspections of establishments.--
Beginning in 2014, not later than February 1 of each
year, the Secretary shall make available on the
Internet Web site of the Food and Drug Administration a
report regarding--
(A)(i) the number of domestic and foreign
establishments registered pursuant to this
section in the previous calendar year; and
(ii) the number of such domestic
establishments and the number of such foreign
establishments that the Secretary inspected in
the previous calendar year;
(B) with respect to establishments that
manufacture, prepare, propagate, compound, or
process an active ingredient of a drug or a
finished drug product, the number of each such
type of establishment; and
(C) the percentage of the budget of the Food
and Drug Administration used to fund the
inspections described under subparagraph (A).
(i)(1) 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--
(A) upon first engaging in any such activity,
immediately submit a registration to the Secretary that
includes--
(i) with respect to drugs, the name and place
of business of such person, all such
establishments, the unique facility identifier
of each such establishment, a point of contact
e-mail address, the name of the United States
agent of each such establishment, the name of
each importer of such drug in the United States
that is known to the establishment, and the
name of each person who imports or offers for
import such drug to the United States for
purposes of importation; and
(ii) with respect to devices, the name and
place of business of the establishment, the
name of the United States agent for the
establishment, the name of each importer of
such device in the United States that is known
to the establishment, and the name of each
person who imports or offers for import such
device to the United States for purposes of
importation; and
(B) each establishment subject to the requirements of
subparagraph (A) shall thereafter register with the
Secretary during the period beginning on October 1 and
ending on December 31 of each year.
(2) The establishment shall also provide the information
required by subsection (j).
(3) The Secretary is authorized to enter into cooperative
arrangements with officials of foreign countries to ensure that
adequate and effective means are available for purposes of
determining, from time to time, whether drugs or devices
manufactured, prepared, propagated, compounded, or processed by
an establishment described in paragraph (1), if imported or
offered for import into the United States, shall be refused
admission on any of the grounds set forth in section 801(a).
(4) The Secretary shall specify the unique facility
identifier system that shall be used by registrants under
paragraph (1) with respect to drugs. The requirement to include
a unique facility identifier in a registration under paragraph
(1) with respect to drugs shall not apply until the date that
the identifier system is specified by the Secretary under the
preceding sentence.
(j)(1) Every person who registers with the Secretary under
subsection (b), (c), (d), or (i) shall, at the time of
registration under any such subsection, file with the Secretary
a list of all drugs and a list of all devices and a brief
statement of the basis for believing that each device included
in the list is a device rather than a drug (with each drug and
device in each list listed by its established name (as defined
in section 502(e)) and by any proprietary name) which are being
manufactured, prepared, propagated, compounded, or processed by
him for commercial distribution and which he has not included
in any list of drugs or devices filed by him with the Secretary
under this paragraph or paragraph (2) before such time of
registration. Such list shall be prepared in such form and
manner as the Secretary may prescribe and shall be accompanied
by--
(A) in the case of a drug contained in the applicable
list and subject to section 505 or 512, or a device
intended for human use contained in the applicable list
with respect to which a performance standard has been
established under section 514 or which is subject to
section 515, a reference to the authority for the
marketing of such drug or device and a copy of all
labeling for such drug or device;
(B) in the case of any other drug or device contained
in an applicable list--
(i) which drug is subject to section
503(b)(1), or which device is a restricted
device, a copy of all labeling for such drug or
device, a representative sampling of
advertisements for such drug or device, and,
upon request made by the Secretary for good
cause, a copy of all advertisements for a
particular drug product or device, or
(ii) which drug is not subject to section
503(b)(1) or which device is not a restricted
device, the label and package insert for such
drug or device and a representative sampling of
any other labeling for such drug or device;
(C) in the case of any drug contained in an
applicable list which is described in subparagraph (B),
a quantitative listing of its active ingredient or
ingredients, except that with respect to a particular
drug product the Secretary may require the submission
of a quantitative listing of all ingredients if he
finds that such submission is necessary to carry out
the purposes of this Act;
(D) if the registrant filing a list has determined
that a particular drug product or device contained in
such list is not subject to section 505 or 512, or the
particular device contained in such list is not subject
to a performance standard established under section 514
or to section 515 or is not a restricted device, a
brief statement of the basis upon which the registrant
made such determination if the Secretary requests such
a statement with respect to that particular drug
product or device; and
(E) in the case of a drug contained in the applicable
list, the name and place of business of each
manufacturer of an excipient of the listed drug with
which the person listing the drug conducts business,
including all establishments used in the production of
such excipient, the unique facility identifier of each
such establishment, and a point of contact e-mail
address for each such excipient manufacturer.
(2) Each person who registers with the Secretary under this
section shall report to the Secretary, with regard to drugs
once during the month of June of each year and once during the
month of December of each year, and with regard to devices once
each year during the period beginning on October 1 and ending
on December 31, the following information:
(A) A list of each drug or device introduced by the
registrant for commercial distribution which has not
been included in any list previously filed by him with
the Secretary under this subparagraph or paragraph (1)
of this subsection. A list under this subparagraph
shall list a drug or device by its established name (as
defined in section 502(e)) and by any proprietary name
it may have and shall be accompanied by the other
information required by paragraph (1).
(B) If since the date the registrant last made a
report under this paragraph (or if he has not made a
report under this paragraph, since the effective date
of this subsection) he has discontinued the
manufacture, preparation, propagation, compounding, or
processing for commercial distribution of a drug or
device included in a list filed by him under
subparagraph (A) or paragraph (1); notice of such
discontinuance, the date of such discontinuance, and
the identity (by established name (as defined in
section 502(e)) and by any proprietary name) of such
drug or device.
(C) If since the date the registrant reported
pursuant to subparagraph (B) a notice of discontinuance
he has resumed the manufacture, preparation,
propagation, compounding, or processing for commercial
distribution of the drug or device with respect to
which such notice of discontinuance was reported;
notice of such resumption, the date of such resumption,
the identity of such drug or device (by established
name (as defined in section 502(e)) and by any
proprietary name), and the other information required
by paragraph (1), unless the registrant has previously
reported such resumption to the Secretary pursuant to
this subparagraph.
(D) Any material change in any information previously
submitted pursuant to this paragraph or paragraph (1).
(3) The Secretary may also require each registrant under this
section to submit a list of each drug product which (A) the
registrant is manufacturing, preparing, propagating,
compounding, or processing for commercial distribution, and (B)
contains a particular ingredient. The Secretary may not require
the submission of such a list unless he has made a finding that
the submission of such a list is necessary to carry out the
purposes of this Act.
(4) The Secretary shall require persons subject to this
subsection to use, for purposes of this subsection, the unique
facility identifier systems specified under subsections (b)(3)
and (i)(4) with respect to drugs. Such requirement shall not
apply until the date that the identifier system under
subsection (b)(3) or (i)(4), as applicable, is specified by the
Secretary.
(k) Each person who is required to register under this
section and who proposes to begin the introduction or delivery
for introduction into interstate commerce for commercial
distribution of a device intended for human use shall, at least
ninety days before making such introduction or delivery, report
to the Secretary or person who is accredited under section
523(a) (in such form and manner as the Secretary shall by
regulation prescribe)--
(1) the class in which the device is classified under
section 513 or if such person determines that the
device is not classified under such section, a
statement of that determination and the basis for such
person's determination that the device is or is not so
classified, and
(2) action taken by such person to comply with
requirements under section 514 or 515 which are
applicable to the device.
A notification submitted under this subsection that contains
clinical trial data for an applicable device clinical trial (as
defined in section 402(j)(1) of the Public Health Service Act)
shall be accompanied by the certification required under
section 402(j)(5)(B) of such Act. Such certification shall not
be considered an element of such notification.
(l)(1) A report under subsection (k) is not required for a
device intended for human use that is exempted from the
requirements of this subsection under subsection (m) or is
within a type that has been classified into class I under
section 513. The exception established in the preceding
sentence does not apply to any class I device that is intended
for a use which is of substantial importance in preventing
impairment of human health, or to any class I device that
presents a potential unreasonable risk of illness or injury.
(2) Not later than 120 calendar days after the date of
enactment of the 21st Century Cures Act and at least once every
5 years thereafter, as the Secretary determines appropriate,
the Secretary shall identify, through publication in the
Federal Register, any type of class I device that the Secretary
determines no longer requires a report under subsection (k) to
provide reasonable assurance of safety and effectiveness. Upon
such publication--
(A) each type of class I device so identified shall
be exempt from the requirement for a report under
subsection (k); and
(B) the classification regulation applicable to each
such type of device shall be deemed amended to
incorporate such exemption.
(m)(1) The Secretary shall--
(A) not later than 90 days after the date of
enactment of the 21st Century Cures Act and at
least once every 5 years thereafter, as the
Secretary determines appropriate--
(i) publish in the Federal Register a
notice that contains a list of each
type of class II device that the
Secretary determines no longer requires
a report under subsection (k) to
provide reasonable assurance of safety
and effectiveness; and
(ii) provide for a period of not less
than 60 calendar days for public
comment beginning on the date of the
publication of such notice; and
(B) not later than 210 calendar days after
the date of enactment of the 21st Century Cures
Act, publish in the Federal Register a list
representing the Secretary's final
determination with respect to the devices
contained in the list published under
subparagraph (A).
(2) Beginning on the date that is 1 calendar day after the
date of publication of the final list under paragraph (1)(B),
the Secretary may exempt a class II device from the requirement
to submit a report under subsection (k), upon the Secretary's
own initiative or a petition of an interested person, if the
Secretary determines that such report is not necessary to
assure the safety and effectiveness of the device. The
Secretary shall publish in the Federal Register notice of the
intent of the Secretary to exempt the device, or of the
petition, and provide a 60-calendar-day period for public
comment. Within 120 days after the issuance of the notice in
the Federal Register, the Secretary shall publish an order in
the Federal Register that sets forth the final determination of
the Secretary regarding the exemption of the device that was
the subject of the notice. If the Secretary fails to respond to
a petition within 180 days of receiving it, the petition shall
be deemed to be granted.
(3) Upon the publication of the final list under paragraph
(1)(B)--
(A) each type of class II device so listed shall be
exempt from the requirement for a report under
subsection (k); and
(B) the classification regulation applicable to each
such type of device shall be deemed amended to
incorporate such exemption.
(n)(1) The Secretary shall review the report required in
subsection (k) and make a determination under section 513(f)(1)
not later than 90 days after receiving the report.
(2)(A) Not later than 18 months after the date of
enactment of this paragraph, the Secretary shall submit
to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a report regarding
when a premarket notification under subsection (k)
should be submitted for a modification or change to a
legally marketed device. The report shall include the
Secretary's interpretation of the following terms:
``could significantly affect the safety or
effectiveness of the device'', ``a significant change
or modification in design, material, chemical
composition, energy source, or manufacturing process'',
and ``major change or modification in the intended use
of the device''. The report also shall discuss possible
processes for industry to use to determine whether a
new submission under subsection (k) is required and
shall analyze how to leverage existing quality system
requirements to reduce premarket burden, facilitate
continual device improvement, and provide reasonable
assurance of safety and effectiveness of modified
devices. In developing such report, the Secretary shall
consider the input of interested stakeholders.
(B) The Secretary shall withdraw the Food and Drug
Administration draft guidance entitled ``Guidance for
Industry and FDA Staff--510(k) Device Modifications:
Deciding When to Submit a 510(k) for a Change to an
Existing Device'', dated July 27, 2011, and shall not
use this draft guidance as part of, or for the basis
of, any premarket review or any compliance or
enforcement decisions or actions. The Secretary shall
not issue--
(i) any draft guidance or proposed regulation
that addresses when to submit a premarket
notification submission for changes and
modifications made to a manufacturer's
previously cleared device before the receipt by
the Committee on Energy and Commerce of the
House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the
Senate of the report required in subparagraph
(A); and
(ii) any final guidance or regulation on that
topic for one year after date of receipt of
such report by the Committee on Energy and
Commerce of the House of Representatives and
the Committee on Health, Education, Labor, and
Pensions of the Senate.
(C) The Food and Drug Administration guidance
entitled ``Deciding When to Submit a 510(k) for a
Change to an Existing Device'', dated January 10, 1997,
shall be in effect until the subsequent issuance of
guidance or promulgation, if appropriate, of a
regulation described in subparagraph (B), and the
Secretary shall interpret such guidance in a manner
that is consistent with the manner in which the
Secretary has interpreted such guidance since 1997.
(o)(1) With respect to reprocessed single-use devices for
which reports are required under subsection (k):
(A) The Secretary shall identify such devices or
types of devices for which reports under such
subsection must, in order to ensure that the device is
substantially equivalent to a predicate device, include
validation data, the types of which shall be specified
by the Secretary, regarding cleaning and sterilization,
and functional performance demonstrating that the
single-use device will remain substantially equivalent
to its predicate device after the maximum number of
times the device is reprocessed as intended by the
person submitting the premarket notification. Within
six months after enactment of this subsection, the
Secretary shall publish in the Federal Register a list
of the types so identified, and shall revise the list
as appropriate. Reports under subsection (k) for
devices or types of devices within a type included on
the list are, upon publication of the list, required to
include such validation data.
(B) In the case of each report under subsection (k)
that was submitted to the Secretary before the
publication of the initial list under subparagraph (A),
or any revision thereof, and was for a device or type
of device included on such list, the person who
submitted the report under subsection (k) shall submit
validation data as described in subparagraph (A) to the
Secretary not later than nine months after the
publication of the list. During such nine-month period,
the Secretary may not take any action under this Act
against such device solely on the basis that the
validation data for the device have not been submitted
to the Secretary. After the submission of the
validation data to the Secretary, the Secretary may not
determine that the device is misbranded under section
502(o) or adulterated under section 501(f)(1)(B), or
take action against the device under section 301(p) for
failure to provide any information required by
subsection (k) until (i) the review is terminated by
withdrawal of the submission of the report under
subsection (k); (ii) the Secretary finds the data to be
acceptable and issues a letter; or (iii) the Secretary
determines that the device is not substantially
equivalent to a predicate device. Upon a determination
that a device is not substantially equivalent to a
predicate device, or if such submission is withdrawn,
the device can no longer be legally marketed.
(C) In the case of a report under subsection (k) for
a device identified under subparagraph (A) that is of a
type for which the Secretary has not previously
received a report under such subsection, the Secretary
may, in advance of revising the list under subparagraph
(A) to include such type, require that the report
include the validation data specified in subparagraph
(A).
(D) Section 502(o) applies with respect to the
failure of a report under subsection (k) to include
validation data required under subparagraph (A).
(2) With respect to critical or semi-critical reprocessed
single-use devices that, under subsection (l) or (m), are
exempt from the requirement of submitting reports under
subsection (k):
(A) The Secretary shall identify such devices or
types of devices for which such exemptions should be
terminated in order to provide a reasonable assurance
of the safety and effectiveness of the devices. The
Secretary shall publish in the Federal Register a list
of the devices or types of devices so identified, and
shall revise the list as appropriate. The exemption for
each device or type included on the list is terminated
upon the publication of the list. For each report under
subsection (k) submitted pursuant to this subparagraph
the Secretary shall require the validation data
described in paragraph (1)(A).
(B) For each device or type of device included on the
list under subparagraph (A), a report under subsection
(k) shall be submitted to the Secretary not later than
15 months after the publication of the initial list, or
a revision of the list, whichever terminates the
exemption for the device. During such 15-month period,
the Secretary may not take any action under this Act
against such device solely on the basis that such
report has not been submitted to the Secretary. After
the submission of the report to the Secretary the
Secretary may not determine that the device is
misbranded under section 502(o) or adulterated under
section 501(f)(1)(B), or take action against the device
under section 301(p) for failure to provide any
information required by subsection (k) until (i) the
review is terminated by withdrawal of the submission;
(ii) the Secretary determines by order that the device
is substantially equivalent to a predicate device; or
(iii) the Secretary determines by order that the device
is not substantially equivalent to a predicate device.
Upon a determination that a device is not substantially
equivalent to a predicate device, the device can no
longer be legally marketed.
(C) In the case of semi-critical devices, the initial
list under subparagraph (A) shall be published not
later than 18 months after the effective date of this
subsection. In the case of critical devices, the
initial list under such subparagraph shall be published
not later than six months after such effective date.
(D) Section 502(o) applies with respect to the
failure to submit a report under subsection (k) that is
required pursuant to subparagraph (A), including a
failure of the report to include validation data
required in such subparagraph.
(E) The termination under subparagraph (A) of an
exemption under subsection (l) or (m) for a critical or
semi-critical reprocessed single-use device does not
terminate the exemption under subsection (l) or (m) for
the original device.
(p) Electronic Registration and Listing.--
(1) In general.--Registrations and listings under
this section (including the submission of updated
information) shall be submitted to the Secretary by
electronic means unless the Secretary grants a request
for waiver of such requirement because use of
electronic means is not reasonable for the person
requesting such waiver.
(2) Electronic database.--Not later than 2 years
after the Secretary specifies a unique facility
identifier system under subsections (b) and (i), the
Secretary shall maintain an electronic database, which
shall not be subject to inspection under subsection
(f), populated with the information submitted as
described under paragraph (1) that--
(A) enables personnel of the Food and Drug
Administration to search the database by any
field of information submitted in a
registration described under paragraph (1), or
combination of such fields; and
(B) uses the unique facility identifier
system to link with other relevant databases
within the Food and Drug Administration,
including the database for submission of
information under section 801(r).
(3) Risk-based information and coordination.--The
Secretary shall ensure the accuracy and coordination of
relevant Food and Drug Administration databases in
order to identify and inform risk-based inspections
under section 510(h).
(q) Reusable Medical Devices.--
(1) In general.--Not later than 180 days after the
date of enactment of the 21st Century Cures Act, the
Secretary shall identify and publish a list of reusable
device types for which reports under subsection (k) are
required to include--
(A) instructions for use, which have been
validated in a manner specified by the
Secretary; and
(B) validation data, the types of which shall
be specified by the Secretary;
regarding cleaning, disinfection, and sterilization,
and for which a substantial equivalence determination
may be based.
(2) Revision of list.--The Secretary shall revise the
list under paragraph (2), as the Secretary determines
appropriate, with notice in the Federal Register.
(3) Content of reports.--Reports under subsection (k)
that are submitted after the publication of the list
described in paragraph (1), for devices or types of
devices included on such list, shall include such
instructions for use and validation data.
* * * * * * *
classification of devices intended for human use
Device Classes
Sec. 513. (a)(1) There are established the following classes
of devices intended for human use:
(A) Class I, General Controls.--
(i) A device for which the controls
authorized by or under section 501, 502, 510,
516, 518, 519, or 520 or any combination of
such sections are sufficient to provide
reasonable assurance of the safety and
effectiveness of the device.
(ii) A device for which insufficient
information exists to determine that the
controls referred to in clause (i) are
sufficient to provide reasonable assurance of
the safety and effectiveness of the device or
to establish special controls to provide such
assurance, but because it--
(I) is not purported or represented
to be for a use in supporting or
sustaining human life or for a use
which is of substantial importance in
preventing impairment of human health,
and
(II) does not present a potential
unreasonable risk of illness or injury,
is to be regulated by the controls referred to
in clause (i).
(B) Class ii, special controls.--A device which
cannot be classified as a class I device because the
general controls by themselves are insufficient to
provide reasonable assurance of the safety and
effectiveness of the device, and for which there is
sufficient information to establish special controls to
provide such assurance, including the promulgation of
performance standards, postmarket surveillance, patient
registries, development and dissemination of guidelines
(including guidelines for the submission of clinical
data in premarket notification submissions in
accordance with section 510(k)), recommendations, and
other appropriate actions as the Secretary deems
necessary to provide such assurance. For a device that
is purported or represented to be for a use in
supporting or sustaining human life, the Secretary
shall examine and identify the special controls, if
any, that are necessary to provide adequate assurance
of safety and effectiveness and describe how such
controls provide such assurance.
(C) Class III, Premarket Approval.--A device which
because--
(i) it (I) cannot be classified as a class I
device because insufficient information exists
to determine that the application of general
controls are sufficient to provide reasonable
assurance of the safety and effectiveness of
the device, and (II) cannot be classified as a
class II device because insufficient
information exists to determine that the
special controls described in subparagraph (B)
would provide reasonable assurance of its
safety and effectiveness, and
(ii)(I) is purported or represented to be for
a use in supporting or sustaining human life or
for a use which is of substantial importance in
preventing impairment of human health, or
(II) presents a potential unreasonable risk
of illness or injury,
is to be subject, in accordance with section 515, to
premarket approval to provide reasonable assurance of
its safety and effectiveness.
If there is not sufficient information to establish a
performance standard for a device to provide reasonable
assurance of its safety and effectiveness, the Secretary may
conduct such activities as may be necessary to develop or
obtain such information.
(2) For purposes of this section and sections 514 and 515,
the safety and effectiveness of a device are to be determined--
(A) with respect to the persons for whose use the
device is represented or intended,
(B) with respect to the conditions of use prescribed,
recommended, or suggested in the labeling of the
device, and
(C) weighing any probable benefit to health from the
use of the device against any probable risk of injury
or illness from such use.
(3)(A) Except as authorized by subparagraph (B), the
effectiveness of a device is, for purposes of this section and
sections 514 and 515, to be determined, in accordance with
regulations promulgated by the Secretary, on the basis of well-
controlled investigations, including 1 or more clinical
investigations where appropriate, by experts qualified by
training and experience to evaluate the effectiveness of the
device, from which investigations it can fairly and responsibly
be concluded by qualified experts that the device will have the
effect it purports or is represented to have under the
conditions of use prescribed, recommended, or suggested in the
labeling of the device.
(B) If the Secretary determines that there exists valid
scientific evidence (other than evidence derived from
investigations described in subparagraph (A))--
(i) which is sufficient to determine the
effectiveness of a device, and
(ii) from which it can fairly and responsibly be
concluded by qualified experts that the device will
have the effect it purports or is represented to have
under the conditions of use prescribed, recommended, or
suggested in the labeling of the device,
then, for purposes of this section and sections 514 and 515,
the Secretary may authorize the effectiveness of the device to
be determined on the basis of such evidence.
(C) In making a determination of a reasonable assurance of
the effectiveness of a device for which an application under
section 515 has been submitted, the Secretary shall consider
whether the extent of data that otherwise would be required for
approval of the application with respect to effectiveness can
be reduced through reliance on postmarket controls.
(D)(i) The Secretary, upon the written request of any person
intending to submit an application under section 515, shall
meet with such person to determine the type of valid scientific
evidence (within the meaning of subparagraphs (A) and (B)) that
will be necessary to demonstrate for purposes of approval of an
application the effectiveness of a device for the conditions of
use proposed by such person. The written request shall include
a detailed description of the device, a detailed description of
the proposed conditions of use of the device, a proposed plan
for determining whether there is a reasonable assurance of
effectiveness, and, if available, information regarding the
expected performance from the device. Within 30 days after such
meeting, the Secretary shall specify in writing the type of
valid scientific evidence that will provide a reasonable
assurance that a device is effective under the conditions of
use proposed by such person.
(ii) Any clinical data, including one or more well-controlled
investigations, specified in writing by the Secretary for
demonstrating a reasonable assurance of device effectiveness
shall be specified as result of a determination by the
Secretary that such data are necessary to establish device
effectiveness. The Secretary shall consider, in consultation
with the applicant, the least burdensome appropriate means of
evaluating device effectiveness that would have a reasonable
likelihood of resulting in approval.
(iii) For purposes of clause (ii), the term ``necessary''
means the minimum required information that would support a
determination by the Secretary that an application provides
reasonable assurance of the effectiveness of the device.
(iv) Nothing in this subparagraph shall alter the criteria
for evaluating an application for premarket approval of a
device.
(v) The determination of the Secretary with respect to the
specification of valid scientific evidence under clauses (i)
and (ii) shall be binding upon the Secretary, unless such
determination by the Secretary could be contrary to the public
health.
Classification; Classification Panels
(b)(1) For purposes of--
(A) determining which devices intended for human use
should be subject to the requirements of general
controls, performance standards, or premarket approval,
and
(B) providing notice to the manufacturers and
importers of such devices to enable them to prepare for
the application of such requirements to devices
manufactured or imported by them,
the Secretary shall classify all such devices (other than
devices classified by subsection (f)) into the classes
established by subsection (a). For the purpose of securing
recommendations with respect to the classification of devices,
the Secretary shall establish panels of experts or use panels
of experts established before the date of the enactment of this
section, or both. Section 14 of the Federal Advisory Committee
Act shall not apply to the duration of a panel established
under this paragraph.
(2) The Secretary shall appoint to each panel established
under paragraph (1) persons who are qualified by training and
experience to evaluate the safety and effectiveness of the
devices to be referred to the panel and who, to the extent
feasible, possess skill in the use of, or experience in the
development, manufacture, or utilization of, such devices. The
Secretary shall make appointments to each panel so that each
panel shall consist of members with adequately diversified
expertise in such fields as clinical and administrative
medicine, engineering, biological and physical sciences, and
other related professions. In addition, each panel shall
include as nonvoting members a representative of consumer
interests and a representative of interests of the device
manufacturing industry. Scientific, trade, and consumer
organizations shall be afforded an opportunity to nominate
individuals for appointment to the panels. No individual who is
in the regular full-time employ of the United States and
engaged in the administration of this Act may be a member of
any panel. The Secretary shall designate one of the members of
each panel to serve as chairman thereof.
(3) Panel members (other than officers or employees of the
United States), while attending meetings or conferences of a
panel or otherwise engaged in its business, shall be entitled
to receive compensation at rates to be fixed by the Secretary,
but not at rates exceeding the daily equivalent of the rate in
effect for grade GS-18 of the General Schedule, for each day so
engaged, including traveltime; and while so serving away from
their homes or regular places of business each member may be
allowed travel expenses (including per diem in lieu of
subsistence) as authorized by section 5703 of title 5, United
States Code, for persons in the Government service employed
intermittently.
(4) The Secretary shall furnish each panel with adequate
clerical and other necessary assistance.
(5)(A) Classification panels covering each type of device
shall be scheduled to meet at such times as may be appropriate
for the Secretary to meet applicable statutory deadlines.
(B) When a device is specifically the subject of review by a
classification panel, the Secretary shall--
(i) ensure that adequate expertise is represented on
the classification panel to assess--
(I) the disease or condition which the device
is intended to cure, treat, mitigate, prevent,
or diagnose; and
(II) the technology of the device; and
(ii) provide an opportunity for the person whose
device is specifically the subject of panel review to
provide recommendations on the expertise needed among
the voting members of the panel.
(C) For purposes of subparagraph (B)(i), the term ``adequate
expertise'' means that the membership of the classification
panel includes--
(i) two or more voting members, with a specialty or
other expertise clinically relevant to the device under
review; and
(ii) at least one voting member who is knowledgeable
about the technology of the device.
(D) The Secretary shall provide an annual opportunity for
patients, representatives of patients, and sponsors of [medical
device submissions] medical devices that may be specifically
the subject of a review by a classification panel to provide
recommendations for individuals with appropriate expertise to
fill voting member positions on classification panels.
(6)(A) Any person whose device is specifically the subject of
review by a classification panel shall have--
(i) the same access to data and information submitted
to a classification panel (except for data and
information that are not available for public
disclosure under section 552 of title 5, United States
Code) as the Secretary;
(ii) the opportunity to submit, for review by a
classification panel, information that is based on the
data or information provided in the application
submitted under section 515 by the person, which
information shall be submitted to the Secretary for
prompt transmittal to the classification panel; and
(iii) the same opportunity as the Secretary to
participate in meetings of the panel, including,
subject to the discretion of the panel chairperson, by
designating a representative who will be provided a
time during the panel meeting to address the panel for
the purpose of correcting misstatements of fact or
providing clarifying information, and permitting the
person or representative to call on experts within the
person's organization to address such specific issues
in the time provided.
(B)(i) Any meeting of a classification panel with respect to
the review of a device shall--
(I) provide adequate time for initial presentations
by the person whose device is specifically the subject
of such review and by the Secretary; and
(II) encourage free and open participation by all
interested persons.
(ii) Following the initial presentations described in clause
(i), the panel may--
(I) pose questions to a designated representative
described in subparagraph (A)(iii); and
(II) consider the responses to such questions in the
panel's review of the device.
(7) After receiving from a classification panel the
conclusions and recommendations of the panel on a matter that
the panel has reviewed, the Secretary shall review the
conclusions and recommendations, shall make a final decision on
the matter in accordance with section 515(d)(2), and shall
notify the affected persons of the decision in writing and, if
the decision differs from the conclusions and recommendations
of the panel, shall include the reasons for the difference.
(8) A classification panel under this subsection shall not be
subject to the annual chartering and annual report requirements
of the Federal Advisory Committee Act.
[(9) The Secretary shall classify an accessory under this
section based on the intended use of the accessory,
notwithstanding the classification of any other device with
which such accessory is intended to be used.]
Classification Panel Organization and Operation
(c)(1) The Secretary shall organize the panels according to
the various fields of clinical medicine and fundamental
sciences in which devices intended for human use are used. The
Secretary shall refer a device to be classified under this
section to an appropriate panel established or authorized to be
used under subsection (b) for its review and for its
recommendation respecting the classification of the device. The
Secretary shall by regulation prescribe the procedure to be
followed by the panels in making their reviews and
recommendations. In making their reviews of devices, the
panels, to the maximum extent practicable, shall provide an
opportunity for interested persons to submit data and views on
the classification of the devices.
(2)(A) Upon completion of a panel's review of a device
referred to it under paragraph (1), the panel shall, subject to
subparagraphs (B) and (C), submit to the Secretary its
recommendation for the classification of the device. Any such
recommendation shall (i) contain (I) a summary of the reasons
for the recommendation, (II) a summary of the data upon which
the recommendation is based, and (III) an identification of the
risks to health (if any) presented by the device with respect
to which the recommendation is made, and (ii) to the extent
practicable, include a recommendation for the assignment of a
priority for the application of the requirements of section 514
or 515 to a device recommended to be classified in class II or
class III.
(B) A recommendation of a panel for the classification of a
device in class I shall include a recommendation as to whether
the device should be exempted from the requirements of section
510, 519, or 520(f).
(C) In the case of a device which has been referred under
paragraph (1) to a panel, and which--
(i) is intended to be implanted in the human body or
is purported or represented to be for a use in
supporting or sustaining human life, and
(ii)(I) has been introduced or delivered for
introduction into interstate commerce for commercial
distribution before the date of enactment of this
section, or
(II) is within a type of device which was so
introduced or delivered before such date and is
substantially equivalent to another device within that
type,
such panel shall recommend to the Secretary that the device be
classified in class III unless the panel determines that
classification of the device in such class is not necessary to
provide reasonable assurance of its safety and effectiveness.
If a panel does not recommend that such a device be classified
in class III, it shall in its recommendation to the Secretary
for the classification of the device set forth the reasons for
not recommending classification of the device in such class.
(3) The panels shall submit to the Secretary within one year
of the date funds are first appropriated for the implementation
of this section their recommendations respecting all devices of
a type introduced or delivered for introduction into interstate
commerce for commercial distribution before the date of the
enactment of this section.
Classification
(d)(1) Upon receipt of a recommendation from a panel
respecting a device, the Secretary shall publish in the Federal
Register the panel's recommendation and a proposed regulation
classifying such device and shall provide interested persons an
opportunity to submit comments on such recommendation and the
proposed regulation. After reviewing such comments, the
Secretary shall, subject to paragraph (2), by regulation
classify such device.
(2)(A) A regulation under paragraph (1) classifying a device
in class I shall prescribe which, if any, of the requirements
of section 510, 519 or 520(f) shall not apply to the device. A
regulation which makes a requirement of section 510, 519, or
520(f) inapplicable to a device shall be accompanied by a
statement of the reasons of the Secretary for making such
requirement inapplicable.
(B) A device described in subsection (c)(2)(C) shall be
classified in class III unless the Secretary determines that
classification of the device in such class is not necessary to
provide reasonable assurance of its safety and effectiveness. A
proposed regulation under paragraph (1) classifying such a
device in a class other than class III shall be accompanied by
a full statement of the reasons of the Secretary (and
supporting documentation and data) for not classifying such
device in such class and an identification of the risks to
health (if any) presented by such device.
(3) In the case of devices classified in class II and devices
classified under this subsection in class III and described in
section 515(b)(1) the Secretary may establish priorities which,
in his discretion, shall be used in applying sections 514 and
515, as appropriate, to such devices.
Classification Changes
(e)(1)(A)(i) Based on new information respecting a device,
the Secretary may, upon the initiative of the Secretary or upon
petition of an interested person, change the classification of
such device, and revoke, on account of the change in
classification, any regulation or requirement in effect under
section 514 or 515 with respect to such device, by
administrative order published in the Federal Register
following publication of a proposed reclassification order in
the Federal Register, a meeting of a device classification
panel described in subsection (b), and consideration of
comments to a public docket, notwithstanding subchapter II of
chapter 5 of title 5, United States Code. The proposed
reclassification order published in the Federal Register shall
set forth the proposed reclassification, and a substantive
summary of the valid scientific evidence concerning the
proposed reclassification, including--
(I) the public health benefit of the use of the
device, and the nature and, if known, incidence of the
risk of the device;
(II) in the case of a reclassification from class II
to class III, why general controls pursuant to
subsection (a)(1)(A) and special controls pursuant to
subsection (a)(1)(B) together are not sufficient to
provide a reasonable assurance of safety and
effectiveness for such device; and
(III) in the case of reclassification from class III
to class II, why general controls pursuant to
subsection (a)(1)(A) and special controls pursuant to
subsection (a)(1)(B) together are sufficient to provide
a reasonable assurance of safety and effectiveness for
such device.
(ii) An order under this subsection changing the
classification of a device from class III to class II may
provide that such classification shall not take effect until
the effective date of a performance standard established under
section 514 for such device.
(B) Authority to issue such administrative order shall not be
delegated below the Director of the Center for Devices and
Radiological Health, acting in consultation with the
Commissioner.
(2) By an order issued under paragraph (1), the Secretary may
change the classification of a device from class III--
(A) to class II if the Secretary determines that
special controls would provide reasonable assurance of
the safety and effectiveness of the device and that
general controls would not provide reasonable assurance
of the safety and effectiveness of the device, or
(B) to class I if the Secretary determines that
general controls would provide reasonable assurance of
the safety and effectiveness of the device.
Initial Classification and Reclassification of Certain Devices
(f)(1) Any device intended for human use which was not
introduced or delivered for introduction into interstate
commerce for commercial distribution before the date of the
enactment of this section is classified in class III unless--
(A) the device--
(i) is within a type of device (I) which was
introduced or delivered for introduction into
interstate commerce for commercial distribution
before such date and which is to be classified
pursuant to subsection (b), or (II) which was
not so introduced or delivered before such date
and has been classified in class I or II, and
(ii) is substantially equivalent to another
device within such type;
(B) the Secretary in response to a petition submitted
under paragraph (3) has classified such device in class
I or II; or
(C) the device is classified pursuant to a request
submitted under paragraph (2).
A device classified in class III under this paragraph shall be
classified in that class until the effective date of an order
of the Secretary under paragraph (2) or (3) classifying the
device in class I or II.
(2)(A)(i) Any person who submits a report under section
510(k) for a type of device that has not been previously
classified under this Act, and that is classified into class
III under paragraph (1), may request, after receiving written
notice of such a classification, the Secretary to classify the
device.
(ii) In lieu of submitting a report under section 510(k) and
submitting a request for classification under clause (i) for a
device, if a person determines there is no legally marketed
device upon which to base a determination of substantial
equivalence (as defined in subsection (i)), a person may submit
a request under this clause for the Secretary to classify the
device.
(iii) Upon receipt of a request under clause (i) or (ii), the
Secretary shall classify the device subject to the request
under the criteria set forth in subparagraphs (A) through (C)
of subsection (a)(1) within 120 days.
(iv) Notwithstanding clause (iii), the Secretary may decline
to undertake a classification request submitted under clause
(ii) if the Secretary identifies a legally marketed device that
could provide a reasonable basis for review of substantial
equivalence under paragraph (1), or when the Secretary
determines that the device submitted is not of low to moderate
risk or that general controls would be inadequate to control
the risks and special controls to mitigate the risks cannot be
developed.
(v) The person submitting the request for classification
under this subparagraph may recommend to the Secretary a
classification for the device and shall, if recommending
classification in class II, include in the request an initial
draft proposal for applicable special controls, as described in
subsection (a)(1)(B), that are necessary, in conjunction with
general controls, to provide reasonable assurance of safety and
effectiveness and a description of how the special controls
provide such assurance. Any such request shall describe the
device and provide detailed information and reasons for the
recommended classification.
(B)(i) The Secretary shall by written order classify the
device involved. Such classification shall be the initial
classification of the device for purposes of paragraph (1) and
any device classified under this paragraph shall be a predicate
device for determining substantial equivalence under paragraph
(1).
(ii) A device that remains in class III under this
subparagraph shall be deemed to be adulterated within the
meaning of section 501(f)(1)(B) until approved under section
515 or exempted from such approval under section 520(g).
(C) Within 30 days after the issuance of an order classifying
a device under this paragraph, the Secretary shall publish a
notice in the Federal Register announcing such classification.
(3)(A) The Secretary may initiate the reclassification of a
device classified into class III under paragraph (1) of this
subsection or the manufacturer or importer of a device
classified under paragraph (1) may petition the Secretary (in
such form and manner as he shall prescribe) for the issuance of
an order classifying the device in class I or class II. Within
thirty days of the filing of such a petition, the Secretary
shall notify the petitioner of any deficiencies in the petition
which prevent the Secretary from making a decision on the
petition.
(B)(i) Upon determining that a petition does not contain any
deficiency which prevents the Secretary from making a decision
on the petition, the Secretary may for good cause shown refer
the petition to an appropriate panel established or authorized
to be used under subsection (b). A panel to which such a
petition has been referred shall not later than ninety days
after the referral of the petition make a recommendation to the
Secretary respecting approval or denial of the petition. Any
such recommendation shall contain (I) a summary of the reasons
for the recommendation, (II) a summary of the data upon which
the recommendation is based, and (III) an identification of the
risks to health (if any) presented by the device with respect
to which the petition was filed. In the case of a petition for
a device which is intended to be implanted in the human body or
which is purported or represented to be for a use in supporting
or sustaining human life, the panel shall recommend that the
petition be denied unless the panel determines that the
classification in class III of the device is not necessary to
provide reasonable assurance of its safety and effectiveness.
If the panel recommends that such petition be approved, it
shall in its recommendation to the Secretary set forth its
reasons for such recommendation.
(ii) The requirements of paragraphs (1) and (2) of subsection
(c) (relating to opportunities for submission of data and views
and recommendations respecting priorities and exemptions from
sections 510, 519, and 520(f)) shall apply with respect to
consideration by panels of petitions submitted under
subparagraph (A).
(C)(i) Within ninety days from the date the Secretary
receives the recommendation of a panel respecting a petition
(but not later than 210 days after the filing of such petition)
the Secretary shall by order deny or approve the petition. If
the Secretary approves the petition, the Secretary shall order
the classification of the device into class I or class II in
accordance with the criteria prescribed by subsection (a)(1)(A)
or (a)(1)(B). In the case of a petition for a device which is
intended to be implanted in the human body or which is
purported or represented to be for a use in supporting or
sustaining human life, the Secretary shall deny the petition
unless the Secretary determines that the classification in
class III of the device is not necessary to provide reasonable
assurance of its safety and effectiveness. An order approving
such petition shall be accompanied by a full statement of the
reasons of the Secretary (and supporting documentation and
data) for approving the petition and an identification of the
risks to health (if any) presented by the device to which such
order applies.
(ii) The requirements of paragraphs (1) and (2)(A) of
subsection (d) (relating to publication of recommendations,
opportunity for submission of comments, and exemption from
sections 510, 519, and 520(f)) shall apply with respect to
action by the Secretary on petitions submitted under
subparagraph (A).
(4) If a manufacturer reports to the Secretary under section
510(k) that a device is substantially equivalent to another
device--
(A) which the Secretary has classified as a class III
device under subsection (b),
(B) which was introduced or delivered for
introduction into interstate commerce for commercial
distribution before December 1, 1990, and
(C) for which no final regulation requiring premarket
approval has been promulgated under section 515(b),
the manufacturer shall certify to the Secretary that the
manufacturer has conducted a reasonable search of all
information known or otherwise available to the manufacturer
respecting such other device and has included in the report
under section 510(k) a summary of and a citation to all adverse
safety and effectiveness data respecting such other device and
respecting the device for which the section 510(k) report is
being made and which has not been submitted to the Secretary
under section 519. The Secretary may require the manufacturer
to submit the adverse safety and effectiveness data described
in the report.
(5) The Secretary may not withhold a determination of the
initial classification of a device under paragraph (1) because
of a failure to comply with any provision of this Act unrelated
to a substantial equivalence decision, including a finding that
the facility in which the device is manufactured is not in
compliance with good manufacturing requirements as set forth in
regulations of the Secretary under section 520(f) (other than a
finding that there is a substantial likelihood that the failure
to comply with such regulations will potentially present a
serious risk to human health).
(6)(A) Subject to the succeeding subparagraphs of this
paragraph, the Secretary shall, by written order, classify an
accessory under this section based on the risks of the
accessory when used as intended and the level of regulatory
controls necessary to provide a reasonable assurance of safety
and effectiveness of the accessory, notwithstanding the
classification of any other device with which such accessory is
intended to be used.
(B) The classification of any accessory distinct from another
device by regulation or written order issued prior to December
13, 2016, shall continue to apply unless and until the
accessory is reclassified by the Secretary, notwithstanding the
classification of any other device with which such accessory is
intended to be used. Nothing in this section shall preclude the
Secretary's ability to initiate the classification of an
accessory through regulation or written order, as appropriate.
(C)(i) In the case of an accessory that has been granted
marketing authorization as part of a submission under section
515(c), 510(k), or paragraph (2) of this subsection with
another device with which such accessory is intended to be
used, and with respect to which the Secretary has issued a
written order classifying such accessory type distinct from
another device in accordance with subparagraph (A), the
manufacturer or importer of such accessory may, in lieu of
submitting a request for classification of such accessory,
submit a written request to the Secretary identifying such
classification. A request under this clause shall include such
information to support the request as may be specified by the
Secretary.
(ii) A request under clause (i) shall include a
recommendation for the proper classification of the accessory
pursuant to subparagraph (A), and shall include such
information as may be necessary for the Secretary to evaluate,
based on the least burdensome approach, the appropriate class
for the accessory under subsection (a).
(iii) The Secretary shall respond to a request under clause
(i) within 90 calendar days by granting or denying the request
for reclassification of the accessory.
(iv) Within 30 calendar days after granting a request
submitted under clause (i), the Secretary shall publish a
notice in the Federal Register announcing such response.
(v) A written notification that the Secretary disagrees with
the classification recommended in a request pursuant to clause
(ii) shall include a detailed description and justification for
the determination to disagree.
(D)(i) In the case of a device intended to be used with an
accessory, where the accessory has been included in an
application for premarket approval of such device under section
515 or a report under section 510(k) for clearance of such
device and the Secretary has not classified such accessory
distinctly from another device in accordance with subparagraph
(A), the person filing the application or report (as
applicable) at the time such application or report is filed--
(I) may include a written request for the proper
classification of the accessory pursuant to
subparagraph (A);
(II) shall include in any such request such
information as may be necessary for the Secretary to
evaluate, based on the least burdensome approach, the
appropriate class for the accessory under subsection
(a); and
(III) shall, if the request under subclause (I) is
requesting classification of the accessory in class II,
include in the application an initial draft proposal
for special controls, if special controls would be
required pursuant to subsection (a)(1)(B).
(ii) The Secretary's response under section 515(d) or section
510(n) (as applicable) to an application or report described in
clause (i) shall also contain the Secretary's granting or
denial of the request for classification of the accessory
involved.
(iii) The Secretary's evaluation of an accessory under clause
(i) shall constitute an order establishing a new classification
for such accessory for the specified intended use or uses of
such accessory and for any accessory with the same intended use
or uses as such accessory.
(E) For accessories that have been granted marketing
authorization as part of a submission for another device with
which the accessory involved is intended to be used, through an
application for such other device under section 515(c), a
report under section 510(k), or a request for classification
under paragraph (2) of this subsection, and that have not been
classified by the Secretary based on the risks and appropriate
level of regulatory controls in accordance with subparagraph
(A):
(i) Not later than the date that is one year after
the date of enactment of the FDA Reauthorization Act of
2017 and at least once every 5 years thereafter, and as
the Secretary otherwise deems appropriate, pursuant to
this paragraph, the Secretary shall publish in the
Federal Register a notice proposing a list of such
accessories that the Secretary believes may be suitable
for a distinct classification in class I and the
proposed regulations for such classifications. In
developing such lists, the Secretary shall consider
recommendations from sponsors of device submissions and
other stakeholders for accessories to be included on
such lists. The notices shall provide for a period of
not less than 60 calendar days for public comment.
Within 180 days after the end of the comment period,
the Secretary shall publish in the Federal Register a
final action classifying such suitable accessories into
class I.
(ii) A manufacturer or importer of an accessory that
has been granted such marketing authorization may
submit to the Secretary a written request for the
appropriate classification of the accessory based on
the risks and appropriate level of regulatory controls
as described in subparagraph (A) or (C), and shall, if
the request is requesting classification of the
accessory in class II, include in the submission an
initial draft proposal for special controls, if special
controls would be required pursuant to subsection
(a)(1)(B). Such request shall include such information
as may be necessary for the Secretary to evaluate,
based on the least burdensome approach, the appropriate
class for the accessory under subsection (a). The
Secretary shall provide an opportunity for a
manufacturer or importer to meet with appropriate
personnel of the Food and Drug Administration to
discuss the appropriate classification of such
accessory prior to submitting a written request under
this clause for classification of the accessory.
(iii) The Secretary shall respond to a request made
under clause (ii) not later than 90 calendar days after
receiving such submission by granting or denying the
request for classification of the accessory, and the
Secretary shall by written order classify such
accessory or deny the request. If the Secretary does
not agree with the recommendation for classification
submitted by the manufacturer or importer, the response
shall include a detailed description and justification
for such determination. Within 30 calendar days after
granting such a request, the Secretary shall publish a
notice in the Federal Register announcing such
response.
(F) Nothing in this paragraph may be construed as precluding
a manufacturer of an accessory of a new type from using the
classification process described in subsection (f)(2) to obtain
classification of such accessory in accordance with the
criteria and requirements set forth in that subsection.
Information
(g) Within sixty days of the receipt of a written request of
any person for information respecting the class in which a
device has been classified or the requirements applicable to a
device under this Act, the Secretary shall provide such person
a written statement of the classification (if any) of such
device and the requirements of this Act applicable to the
device.
Definitions
(h) For purposes of this section and sections 501, 510, 514,
515, 516, 519, and 520--
(1) a reference to ``general controls'' is a
reference to the controls authorized by or under
sections 501, 502, 510, 516, 518, 519, and 520,
(2) a reference to ``class I,''``class II,'' or
``class III'' is a reference to a class of medical
devices described in subparagraph (A), (B), or (C) of
subsection (a)(1), and
(3) a reference to a ``panel under section 513'' is a
reference to a panel established or authorized to be
used under this section.
Substantial Equivalence
(i)(1)(A) For purposes of determinations of substantial
equivalence under subsection (f) and section 520(l), the term
``substantially equivalent'' or ``substantial equivalence''
means, with respect to a device being compared to a predicate
device, that the device has the same intended use as the
predicate device and that the Secretary by order has found that
the device--
(i) has the same technological characteristics as the
predicate device, or
(ii)(I) has different technological characteristics
and the information submitted that the device is
substantially equivalent to the predicate device
contains information, including appropriate clinical or
scientific data if deemed necessary by the Secretary or
a person accredited under section 523, that
demonstrates that the device is as safe and effective
as a legally marketed device, and (II) does not raise
different questions of safety and effectiveness than
the predicate device.
(B) For purposes of subparagraph (A), the term ``different
technological characteristics'' means, with respect to a device
being compared to a predicate device, that there is a
significant change in the materials, design, energy source, or
other features of the device from those of the predicate
device.
(C) To facilitate reviews of reports submitted to the
Secretary under section 510(k), the Secretary shall consider
the extent to which reliance on postmarket controls may
expedite the classification of devices under subsection (f)(1)
of this section.
(D)(i) Whenever the Secretary requests information to
demonstrate that devices with differing technological
characteristics are substantially equivalent, the Secretary
shall only request information that is necessary to making
substantial equivalence determinations. In making such request,
the Secretary shall consider the least burdensome means of
demonstrating substantial equivalence and request information
accordingly.
(ii) For purposes of clause (i), the term ``necessary'' means
the minimum required information that would support a
determination of substantial equivalence between a new device
and a predicate device.
(iii) Nothing in this subparagraph shall alter the standard
for determining substantial equivalence between a new device
and a predicate device.
(E)(i) Any determination by the Secretary of the intended use
of a device shall be based upon the proposed labeling submitted
in a report for the device under section 510(k). However, when
determining that a device can be found substantially equivalent
to a legally marketed device, the director of the
organizational unit responsible for regulating devices (in this
subparagraph referred to as the ``Director'') may require a
statement in labeling that provides appropriate information
regarding a use of the device not identified in the proposed
labeling if, after providing an opportunity for consultation
with the person who submitted such report, the Director
determines and states in writing--
(I) that there is a reasonable likelihood that the
device will be used for an intended use not identified
in the proposed labeling for the device; and
(II) that such use could cause harm.
(ii) Such determination shall--
(I) be provided to the person who submitted the
report within 10 days from the date of the notification
of the Director's concerns regarding the proposed
labeling;
(II) specify the limitations on the use of the device
not included in the proposed labeling; and
(III) find the device substantially equivalent if the
requirements of subparagraph (A) are met and if the
labeling for such device conforms to the limitations
specified in subclause (II).
(iii) The responsibilities of the Director under this
subparagraph may not be delegated.
(F) Not later than 270 days after the date of the enactment
of the Food and Drug Administration Modernization Act of 1997,
the Secretary shall issue guidance specifying the general
principles that the Secretary will consider in determining when
a specific intended use of a device is not reasonably included
within a general use of such device for purposes of a
determination of substantial equivalence under subsection (f)
or section 520(l).
(2) A device may not be found to be substantially equivalent
to a predicate device that has been removed from the market at
the initiative of the Secretary or that has been determined to
be misbranded or adulterated by a judicial order.
(3)(A) As part of a submission under section 510(k)
respecting a device, the person required to file a premarket
notification under such section shall provide an adequate
summary of any information respecting safety and effectiveness
or state that such information will be made available upon
request by any person.
(B) Any summary under subparagraph (A) respecting a device
shall contain detailed information regarding data concerning
adverse health effects and shall be made available to the
public by the Secretary within 30 days of the issuance of a
determination that such device is substantially equivalent to
another device.
(j) Training and Oversight of Least Burdensome
Requirements.--
(1) The Secretary shall--
(A) ensure that each employee of the Food and
Drug Administration who is involved in the
review of premarket submissions, including
supervisors, receives training regarding the
meaning and implementation of the least
burdensome requirements under subsections
(a)(3)(D) and (i)(1)(D) of this section and
section 515(c)(5); and
(B) periodically assess the implementation of
the least burdensome requirements, including
the employee training under subparagraph (A),
to ensure that the least burdensome
requirements are fully and consistently
applied.
(2) Not later than 18 months after the date of
enactment of the 21st Century Cures Act, the ombudsman
for any organizational unit of the Food and Drug
Administration responsible for the premarket review of
devices shall--
(A) conduct an audit of the training
described in paragraph (1)(A), including the
effectiveness of such training in implementing
the least burdensome requirements;
(B) include in such audit interviews of
persons who are representatives of the device
industry regarding their experiences in the
device premarket review process, including with
respect to the application of least burdensome
concepts to premarket review and
decisionmaking;
(C) include in such audit a list of the
measurement tools the Secretary uses to assess
the implementation of the least burdensome
requirements, including under paragraph (1)(B)
and section 517A(a)(3), and may also provide
feedback on the effectiveness of such tools in
the implementation of the least burdensome
requirements;
(D) summarize the findings of such audit in a
final audit report; and
(E) within 30 calendar days of completion of
such final audit report, make such final audit
report available--
(i) 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
(ii) on the Internet website of the
Food and Drug Administration.
performance standards
Provisions of Standards
Sec. 514. (a)(1) The special controls required by section
513(a)(1)(B) shall include performance standards for a class II
device if the Secretary determines that a performance standard
is necessary to provide reasonable assurance of the safety and
effectiveness of the device. A class III device may also be
considered a class II device for purposes of establishing a
standard for the device under subsection (b) if the device has
been reclassified as a class II device under an administrative
order under section 513(e) (or a regulation promulgated under
such section prior to the date of enactment of the Food and
Drug Administration Safety and Innovation Act) but such order
(or regulation) provides that the reclassification is not to
take effect until the effective date of such a standard for the
device.
(2) A performance standard established under subsection (b)
for a device--
(A) shall include provisions to provide reasonable
assurance of its safe and effective performance;
(B) shall, where necessary to provide reasonable
assurance of its safe and effective performance,
include--
(i) provisions respecting the construction,
components, ingredients, and properties of the
device and its compatibility with power systems
and connections to such systems,
(ii) provisions for the testing (on a sample
basis or, if necessary, on an individual basis)
of the device or, if it is determined that no
other more practicable means are available to
the Secretary to assure the conformity of the
device to the standard, provisions for the
testing (on a sample basis or, if necessary, on
an individual basis) by the Secretary or by
another person at the direction of the
Secretary,
(iii) provisions for the measurement of the
performance characteristics of the device,
(iv) provisions requiring that the results of
each or of certain of the tests of the device
required to be made under clause (ii) show that
the device is in conformity with the portions
of the standard for which the test or tests
were required, and
(v) a provision requiring that the sale and
distribution of the device be restricted but
only to the extent that the sale and
distribution of a device may be restricted
under a regulation under section 520(e); and
(C) shall, where appropriate, require the use and
prescribe the form and content of labeling for the
proper installation, maintenance, operation, and use of
the device.
(3) The Secretary shall provide for periodic evaluation of
performance standards established under subsection (b) to
determine if such standards should be changed to reflect new
medical, scientific, or other technological data.
(4) In carrying out his duties under this subsection and
subsection (b), the Secretary shall, to the maximum extent
practicable--
(A) use personnel, facilities, and other technical
support available in other Federal agencies,
(B) consult with other Federal agencies concerned
with standard-setting and other nationally or
internationally recognized standard-setting entities,
and
(C) invite appropriate participation, through joint
or other conferences, workshops, or other means, by
informed persons representative of scientific,
professional, industry, or consumer organizations who
in his judgment can make a significant contribution.
Establishment of a Standard
(b)(1)(A) The Secretary shall publish in the Federal Register
a notice of proposed rulemaking for the establishment,
amendment, or revocation of any performance standard for a
device.
(B) A notice of proposed rulemaking for the establishment or
amendment of a performance standard for a device shall--
(i) set forth a finding with supporting justification
that the performance standard is appropriate and
necessary to provide reasonable assurance of the safety
and effectiveness of the device,
(ii) set forth proposed findings with respect to the
risk of illness or injury that the performance standard
is intended to reduce or eliminate,
(iii) invite interested persons to submit to the
Secretary, within 30 days of the publication of the
notice, requests for changes in the classification of
the device pursuant to section 513(e) based on new
information relevant to the classification, and
(iv) invite interested persons to submit an existing
performance standard for the device, including a draft
or proposed performance standard, for consideration by
the Secretary.
(C) A notice of proposed rulemaking for the revocation of a
performance standard shall set forth a finding with supporting
justification that the performance standard is no longer
necessary to provide reasonable assurance of the safety and
effectiveness of a device.
(D) The Secretary shall provide for a comment period of not
less than 60 days.
(2) If, after publication of a notice in accordance with
paragraph (1), the Secretary receives a request for a change in
the classification of the device, the Secretary shall, within
60 days of the publication of the notice, after consultation
with the appropriate panel under section 513, either deny the
request or give notice of an intent to initiate such change
under section 513(e).
(3)(A) After the expiration of the period for comment on a
notice of proposed rulemaking published under paragraph (1)
respecting a performance standard and after consideration of
such comments and any report from an advisory committee under
paragraph (5), the Secretary shall (i) promulgate a regulation
establishing a performance standard and publish in the Federal
Register findings on the matters referred to in paragraph (1),
or (ii) publish a notice terminating the proceeding for the
development of the standard together with the reasons for such
termination. If a notice of termination is published, the
Secretary shall (unless such notice is issued because the
device is a banned device under section 516) initiate a
proceeding under section 513(e) to reclassify the device
subject to the proceeding terminated by such notice.
(B) A regulation establishing a performance standard shall
set forth the date or dates upon which the standard shall take
effect, but no such regulation may take effect before one year
after the date of its publication unless (i) the Secretary
determines that an earlier effective date is necessary for the
protection of the public health and safety, or (ii) such
standard has been established for a device which, effective
upon the effective date of the standard, has been reclassified
from class III to class II. Such date or dates shall be
established so as to minimize, consistent with the public
health and safety, economic loss to, and disruption or
dislocation of, domestic and international trade.
(4)(A) The Secretary, upon his own initiative or upon
petition of an interested person may by regulation, promulgated
in accordance with the requirements of paragraphs (1), (2), and
(3)(B) of this subsection, amend or revoke a performance
standard.
(B) The Secretary may declare a proposed amendment of a
performance standard to be effective on and after its
publication in the Federal Register and until the effective
date of any final action taken on such amendment if he
determines that making it so effective is in the public
interest. A proposed amendment of a performance standard made
so effective under the preceding sentence may not prohibit,
during the period in which it is so effective, the introduction
or delivery for introduction into interstate commerce of a
device which conforms to such standard without the change or
changes provided by such proposed amendment.
(5)(A) The Secretary--
(i) may on his own initiative refer a proposed
regulation for the establishment, amendment, or
revocation of a performance standard, or
(ii) shall, upon the request of an interested person
which demonstrates good cause for referral and which is
made before the expiration of the period for submission
of comments on such proposed regulation refer such
proposed regulation,
to an advisory committee of experts, established pursuant to
subparagraph (B) for a report and recommendation with respect
to any matter involved in the proposed regulation which
requires the exercise of scientific judgment. If a proposed
regulation is referred under this subparagraph to an advisory
committee, the Secretary shall provide the advisory committee
with the data and information on which such proposed regulation
is based. The advisory committee shall, within sixty days of
the referral of a proposed regulation and after independent
study of the data and information furnished to it by the
Secretary and other data and information before it, submit to
the Secretary a report and recommendation respecting such
regulation, together with all underlying data and information
and a statement of the reason or basis for the recommendation.
A copy of such report and recommendation shall be made public
by the Secretary.
(B) The Secretary shall establish advisory committees (which
may not be panels under section 513) to receive referrals under
subparagraph (A). The Secretary shall appoint as members of any
such advisory committee persons qualified in the subject matter
to be referred to the committee and of appropriately
diversified professional background, except that the Secretary
may not appoint to such a committee any individual who is in
the regular full-time employ of the United States and engaged
in the administration of this Act. Each such committee shall
include as nonvoting members a representative of consumer
interests and a representative of interests of the device
manufacturing industry. Members of an advisory committee who
are not officers or employees of the United States, while
attending conferences or meetings of their committee or
otherwise serving at the request of the Secretary, shall be
entitled to receive compensation at rates to be fixed by the
Secretary, which rates may not exceed the daily equivalent of
the rate in effect for grade GS-18 of the General Schedule, for
each day (including traveltime) they are so engaged; and while
so serving away from their homes or regular places of business
each member may be allowed travel expenses, including per diem
in lieu of subsistence, as authorized by section 5703 of title
5 of the United States Code for persons in the Government
service employed intermittently. The Secretary shall designate
one of the members of each advisory committee to serve as
chairman thereof. The Secretary shall furnish each advisory
committee with clerical and other assistance, and shall by
regulation prescribe the procedures to be followed by each such
committee in acting on referrals made under subparagraph (A).
Recognition of a Standard
(c)(1)(A) In addition to establishing a performance standard
under this section, the Secretary shall, by publication in the
Federal Register (or, with respect to a susceptibility test
interpretive criteria standard under section 511A, by posting
on the Interpretive Criteria Website in accordance with such
section), recognize all or part of an appropriate standard
established by a nationally or internationally recognized
standard development organization for which a person may submit
a declaration of conformity in order to meet a premarket
submission requirement or other requirement under this Act to
which such standard is applicable.
(B) If a person elects to use a standard recognized by the
Secretary under subparagraph (A) to meet the requirements
described in such subparagraph, the person shall provide a
declaration of conformity to the Secretary that certifies that
the device is in conformity with such standard. A person may
elect to use data, or information, other than data required by
a standard recognized under subparagraph (A) to meet any
requirement regarding devices under this Act.
(C)(i) Any person may submit a request for recognition under
subparagraph (A) of all or part of an appropriate standard
established by a nationally or internationally recognized
standard organization.
(ii) Not later than 60 calendar days after the Secretary
receives such a request, the Secretary shall--
(I) make a determination to recognize all, part, or
none of the standard that is the subject of the
request; and
(II) issue to the person who submitted such request a
response in writing that states the Secretary's
rationale for that determination, including the
scientific, technical, regulatory, or other basis for
such determination.
(iii) The Secretary shall make a response issued under clause
(ii)(II) publicly available, in such a manner as the Secretary
determines appropriate.
(iv) The Secretary shall take such actions as may be
necessary to implement all or part of a standard recognized
under clause (ii)(I), in accordance with subparagraph (A).
(D) The Secretary shall make publicly available, in such
manner as the Secretary determines appropriate, the rationale
for recognition under subparagraph (A) of all, part, or none of
a standard, including the scientific, technical, regulatory, or
other basis for the decision regarding such recognition.
(2) The Secretary may withdraw such recognition of a standard
through publication of a notice in the Federal Register if the
Secretary determines that the standard is no longer appropriate
for meeting a requirement regarding devices under this Act.
(3)(A) Subject to subparagraph (B), the Secretary shall
accept a declaration of conformity that a device is in
conformity with a standard recognized under paragraph (1)
unless the Secretary finds--
(i) that the data or information submitted to support
such declaration does not demonstrate that the device
is in conformity with the standard identified in the
declaration of conformity; or
(ii) that the standard identified in the declaration
of conformity is not applicable to the particular
device under review.
(B) The Secretary may request, at any time, the data or
information relied on by the person to make a declaration of
conformity with respect to a standard recognized under
paragraph (1).
(C) A person making a declaration of conformity with respect
to a standard recognized under paragraph (1) shall maintain the
data and information demonstrating conformity of the device to
the standard for a period of two years after the date of the
classification or approval of the device by the Secretary or a
period equal to the expected design life of the device,
whichever is longer.
(4) The Secretary shall provide to all employees of the Food
and Drug Administration who review premarket submissions for
devices periodic training on the concept and use of recognized
standards for purposes of meeting a premarket submission
requirement or other applicable requirement under this Act,
including standards relevant to an employee's area of device
review.
(d) Pilot Accreditation Scheme for Conformity Assessment.--
(1) In general.--The Secretary shall establish a
pilot program under which--
(A) testing laboratories may be accredited,
by accreditation bodies meeting criteria
specified by the Secretary, to assess the
conformance of a device with certain standards
recognized under this section; and
(B) subject to paragraph (2), determinations
by testing laboratories so accredited that a
device conforms with such standard or standards
shall be accepted by the Secretary for purposes
of demonstrating such conformity under this
section unless the Secretary finds that a
particular such determination shall not be so
accepted.
(2) Secretarial review of accredited laboratory
determinations.--The Secretary may--
(A) review determinations by testing
laboratories accredited pursuant to this
subsection, including by conducting periodic
audits of such determinations or processes of
accredited bodies or testing laboratories and,
following such review, taking additional
measures under this Act, such as suspension or
withdrawal of accreditation of such testing
laboratory under paragraph (1)(A) or requesting
additional information with respect to such
device, as the Secretary determines
appropriate; and
(B) if the Secretary becomes aware of
information materially bearing on safety or
effectiveness of a device assessed for
conformity by a testing laboratory so
accredited, take such additional measures under
this Act as the Secretary determines
appropriate, such as suspension or withdrawal
of accreditation of such testing laboratory
under paragraph (1)(A), or requesting
additional information with regard to such
device.
(3) Implementation and reporting.--
(A) Public meeting.--The Secretary shall
publish in the Federal Register a notice of a
public meeting to be held no later than
September 30, 2018, to discuss and obtain input
and recommendations from stakeholders regarding
the goals and scope of, and a suitable
framework and procedures and requirements for,
the pilot program under this subsection.
(B) Pilot program guidance.--The Secretary
shall--
(i) not later than September 30,
2019, issue draft guidance regarding
the goals and implementation of the
pilot program under this subsection;
and
(ii) not later than September 30,
2021, issue final guidance with respect
to the implementation of such program.
(C) Pilot program initiation.--Not later than
September 30, 2020, the Secretary shall
initiate the pilot program under this
subsection.
(D) Report.--The Secretary shall make
available on the website of the Food and Drug
Administration an annual report on the progress
of the pilot program under this subsection.
(4) Sunset.--As of October 1, 2022--
(A) the authority for accreditation bodies to
accredit testing laboratories pursuant to
paragraph (1)(A) shall cease to have force or
effect;
(B) the Secretary--
(i) may not accept a determination
pursuant to paragraph (1)(B) made by a
testing laboratory after such date; and
(ii) may accept such a determination
made prior to such date;
(C) except for purposes of accepting a
determination described in subparagraph
(B)(ii), the Secretary shall not continue to
recognize the accreditation of testing
laboratories accredited under paragraph (1)(A);
and
(D) the Secretary may take actions in
accordance with paragraph (2) with respect to
the determinations made prior to such date and
recognition of the accreditation of testing
laboratories pursuant to determinations made
prior to such date.
premarket approval
General Requirement
Sec. 515. (a) A class III device--
(1) which is subject to an order issued under
subsection (b) (or a regulation promulgated under such
subsection prior to the date of enactment of the Food
and Drug Administration Safety and Innovation Act); or
(2) which is a class III device because of section
513(f),
is required to have, unless exempt under section 520(g), an
approval under this section of an application for premarket
approval or, as applicable, an approval under subsection (c)(2)
of a report seeking premarket approval.
Order To Require Premarket Approval
(b)(1) In the case of a class III device which--
(A) was introduced or delivered for introduction into
interstate commerce for commercial distribution before
the date of enactment of this section; or
(B) is (i) of a type so introduced or delivered, and
(ii) is substantially equivalent to another device
within that type;
the Secretary shall 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, require that such device have an approval under
this section of an application for premarket approval.
Authority to issue such administrative order shall not be
delegated below the Director of the Center for Devices and
Radiological Health, acting in consultation with the
Commissioner.
(2) A proposed order required under paragraph (1) shall
contain--
(A) the proposed order;
(B) proposed findings with respect to the degree of
risk of illness or injury designed to be eliminated or
reduced by requiring the device to have an approved
application for premarket approval and the benefit to
the public from use of the device;
(C) opportunity for the submission of comments on the
proposed order and the proposed findings; and
(D) opportunity to request a change in the
classification of the device based on new information
relevant to the classification of the device.
(3) After the expiration of the period for comment on a
proposed order and proposed findings published under paragraph
(2), consideration of comments submitted on such proposed order
and findings, and a meeting of a device classification panel
described in section 513(b), the Secretary shall (A) issue an
administrative order under paragraph (1) and publish in the
Federal Register findings on the matters referred to in
paragraph (2)(B), or (B) publish a notice terminating the
proceeding for the issuance of the administrative order
together with the reasons for such termination. If a notice of
termination is published, the Secretary shall (unless such
notice is issued because the device is a banned device under
section 516) initiate a proceeding under section 513(e) to
reclassify the device subject to the proceeding terminated by
such notice.
Application for Premarket Approval
(c)(1) Any person may file with the Secretary an application
for premarket approval for a class III device. Such an
application for a device shall contain--
(A) full reports of all information, published or
known to or which should reasonably be known to the
applicant, concerning investigations which have been
made to show whether or not such device is safe and
effective;
(B) a full statement of the components, ingredients,
and properties and of the principle or principles of
operation, of such device;
(C) a full description of the methods used in, and
the facilities and controls used for, the manufacture,
processing, and, when relevant, packing and
installation of, such device;
(D) an identifying reference to any performance
standard under section 514 which would be applicable to
any aspect of such device if it were a class II device,
and either adequate information to show that such
aspect of such device fully meets such performance
standard or adequate information to justify any
deviation from such standard;
(E) such samples of such device and of components
thereof as the Secretary may reasonably require, except
that where the submission of such samples is
impracticable or unduly burdensome, the requirement of
this subparagraph may be met by the submission of
complete information concerning the location of one or
more such devices readily available for examination and
testing;
(F) specimens of the labeling proposed to be used for
such device;
(G) the certification required under section
402(j)(5)(B) of the Public Health Service Act
(which shall not be considered an element of
such application); and
(H) such other information relevant to the subject
matter of the application as the Secretary, with the
concurrence of the appropriate panel under section 513,
may require.
(2)(A) Any person may file with the Secretary a report
seeking premarket approval for a class III device referred to
in subsection (a) that is a reprocessed single-use device. Such
a report shall contain the following:
(i) The device name, including both the trade or
proprietary name and the common or usual name.
(ii) The establishment registration number of the
owner or operator submitting the report.
(iii) Actions taken to comply with performance
standards under section 514.
(iv) Proposed labels, labeling, and advertising
sufficient to describe the device, its intended use,
and directions for use.
(v) Full reports of all information, published or
known to or which should be reasonably known to the
applicant, concerning investigations which have been
made to show whether or not the device is safe or
effective.
(vi) A description of the device's components,
ingredients, and properties.
(vii) A full description of the methods used in, and
the facilities and controls used for, the reprocessing
and packing of the device.
(viii) Such samples of the device that the Secretary
may reasonably require.
(ix) A financial certification or disclosure
statement or both, as required by part 54 of title 21,
Code of Federal Regulations.
(x) A statement that the applicant believes to the
best of the applicant's knowledge that all data and
information submitted to the Secretary are truthful and
accurate and that no material fact has been omitted in
the report.
(xi) Any additional data and information, including
information of the type required in paragraph (1) for
an application under such paragraph, that the Secretary
determines is necessary to determine whether there is
reasonable assurance of safety and effectiveness for
the reprocessed device.
(xii) Validation data described in section
510(o)(1)(A) that demonstrates that the reasonable
assurance of the safety or effectiveness of the device
will remain after the maximum number of times the
device is reprocessed as intended by the person
submitting such report.
(B) In the case of a class III device referred to in
subsection (a) that is a reprocessed single-use device:
(i) Subparagraph (A) of this paragraph applies in
lieu of paragraph (1).
(ii) Subject to clause (i), the provisions of this
section apply to a report under subparagraph (A) to the
same extent and in the same manner as such provisions
apply to an application under paragraph (1).
(iii) Each reference in other sections of this Act to
an application under this section, other than such a
reference in section 737 or 738, shall be considered to
be a reference to a report under subparagraph (A).
(iv) Each reference in other sections of this Act to
a device for which an application under this section
has been approved, or has been denied, suspended, or
withdrawn, other than such a reference in section 737
or 738, shall be considered to be a reference to a
device for which a report under subparagraph (A) has
been approved, or has been denied, suspended, or
withdrawn, respectively.
(3) Upon receipt of an application meeting the requirements
set forth in paragraph (1), the Secretary--
(A) may on the Secretary's own initiative, or
(B) shall, upon the request of an applicant unless
the Secretary finds that the information in the
application which would be reviewed by a panel
substantially duplicates information which has
previously been reviewed by a panel appointed under
section 513,
refer such application to the appropriate panel under section
513 for study and for submission (within such period as he may
establish) of a report and recommendation respecting approval
of the application, together with all underlying data and the
reasons or basis for the recommendation. Where appropriate, the
Secretary shall ensure that such panel includes, or consults
with, one or more pediatric experts.
(4)(A) Prior to the submission of an application under this
subsection, the Secretary shall accept and review any portion
of the application that the applicant and the Secretary agree
is complete, ready, and appropriate for review, except that
such requirement does not apply, and the Secretary has
discretion whether to accept and review such portion, during
any period in which, under section [738(h)] 738(g), the
Secretary does not have the authority to collect fees under
section 738(a).
(B) Each portion of a submission reviewed under subparagraph
(A) and found acceptable by the Secretary shall not be further
reviewed after receipt of an application that satisfies the
requirements of paragraph (1), unless a significant issue of
safety or effectiveness provides the Secretary reason to review
such accepted portion.
(C) Whenever the Secretary determines that a portion of a
submission under subparagraph (A) is unacceptable, the
Secretary shall, in writing, provide to the applicant a
description of any deficiencies in such portion and identify
the information that is required to correct these deficiencies,
unless the applicant is no longer pursuing the application.
(5)(A) In requesting additional information with respect to
an application under this section, the Secretary shall consider
the least burdensome appropriate means necessary to demonstrate
a reasonable assurance of device safety and effectiveness.
(B) For purposes of subparagraph (A), the term ``necessary''
means the minimum required information that would support a
determination by the Secretary that an application provides a
reasonable assurance of the safety and effectiveness of the
device.
(C) For purposes of this paragraph, the Secretary shall
consider the role of postmarket information in determining the
least burdensome means of demonstrating a reasonable assurance
of device safety and effectiveness.
(D) Nothing in this paragraph alters the standards for
premarket approval of a device.
Action on an Application for Premarket Approval
(d)(1)(A) As promptly as possible, but in no event later than
one hundred and eighty days after the receipt of an application
under subsection (c) (except as provided in section
520(l)(3)(D)(ii) or unless, in accordance with subparagraph
(B)(i), an additional period as agreed upon by the Secretary
and the applicant), the Secretary, after considering the report
and recommendation submitted under paragraph (2) of such
subsection, shall--
(i) issue an order approving the application if he
finds that none of the grounds for denying approval
specified in paragraph (2) of this subsection applies;
or
(ii) deny approval of the application if he finds
(and sets forth the basis for such finding as part of
or accompanying such denial) that one or more grounds
for denial specified in paragraph (2) of this
subsection apply.
In making the determination whether to approve or deny the
application, the Secretary shall rely on the conditions of use
included in the proposed labeling as the basis for determining
whether or not there is a reasonable assurance of safety and
effectiveness, if the proposed labeling is neither false nor
misleading. In determining whether or not such labeling is
false or misleading, the Secretary shall fairly evaluate all
material facts pertinent to the proposed labeling.
(B)(i) The Secretary may not enter into an agreement to
extend the period in which to take action with respect to an
application submitted for a device subject to a regulation
promulgated under subsection (b) unless he finds that the
continued availability of the device is necessary for the
public health.
(ii) An order approving an application for a device may
require as a condition to such approval that the sale and
distribution of the device be restricted but only to the extent
that the sale and distribution of a device may be restricted
under a regulation under section 520(e).
(iii) The Secretary shall accept and review statistically
valid and reliable data and any other information from
investigations conducted under the authority of regulations
required by section 520(g) to make a determination of whether
there is a reasonable assurance of safety and effectiveness of
a device subject to a pending application under this section
if--
(I) the data or information is derived from
investigations of an earlier version of the device, the
device has been modified during or after the
investigations (but prior to submission of an
application under subsection (c)) and such a
modification of the device does not constitute a
significant change in the design or in the basic
principles of operation of the device that would
invalidate the data or information; or
(II) the data or information relates to a device
approved under this section, is available for use under
this Act, and is relevant to the design and intended
use of the device for which the application is pending.
(2) The Secretary shall deny approval of an application for a
device if, upon the basis of the information submitted to the
Secretary as part of the application and any other information
before him with respect to such device, the Secretary finds
that--
(A) there is a lack of a showing of reasonable
assurance that such device is safe under the conditions
of use prescribed, recommended, or suggested in the
proposed labeling thereof;
(B) there is a lack of a showing of reasonable
assurance that the device is effective under the
conditions of use prescribed, recommended, or suggested
in the proposed labeling thereof;
(C) the methods used in, or the facilities or
controls used for, the manufacture, processing,
packing, or installation of such device do not conform
to the requirements of section 520(f);
(D) based on a fair evaluation of all material facts,
the proposed labeling is false or misleading in any
particular; or
(E) such device is not shown to conform in all
respects to a performance standard in effect under
section 514 compliance with which is a condition to
approval of the application and there is a lack of
adequate information to justify the deviation from such
standard.
Any denial of an application shall, insofar as the Secretary
determines to be practicable, be accompanied by a statement
informing the applicant of the measures required to place such
application in approvable form (which measures may include
further research by the applicant in accordance with one or
more protocols prescribed by the Secretary).
(3)(A)(i) The Secretary shall, upon the written request of an
applicant, meet with the applicant, not later than 100 days
after the receipt of an application that has been filed as
complete under subsection (c), to discuss the review status of
the application.
(ii) The Secretary shall, in writing and prior to the
meeting, provide to the applicant a description of any
deficiencies in the application that, at that point, have been
identified by the Secretary based on an interim review of the
entire application and identify the information that is
required to correct those deficiencies.
(iii) The Secretary shall notify the applicant promptly of--
(I) any additional deficiency identified in the
application, or
(II) any additional information required to achieve
completion of the review and final action on the
application,
that was not described as a deficiency in the written
description provided by the Secretary under clause (ii).
(B) The Secretary and the applicant may, by mutual consent,
establish a different schedule for a meeting required under
this paragraph.
(4) An applicant whose application has been denied approval
may, by petition filed on or before the thirtieth day after the
date upon which he receives notice of such denial, obtain
review thereof in accordance with either paragraph (1) or (2)
of subsection (g), and any interested person may obtain review,
in accordance with paragraph (1) or (2) of subsection (g), of
an order of the Secretary approving an application.
(5)(A)(i) A supplemental application shall be required for
any change to a device subject to an approved application under
this subsection that affects safety or effectiveness, unless
such change is a modification in a manufacturing procedure or
method of manufacturing and the holder of the approved
application submits a written notice to the Secretary that
describes in detail the change, summarizes the data or
information supporting the change, and informs the Secretary
that the change has been made under the requirements of section
520(f).
(ii) The holder of an approved application who submits a
notice under clause (i) with respect to a manufacturing change
of a device may distribute the device 30 days after the date on
which the Secretary receives the notice, unless the Secretary
within such 30-day period notifies the holder that the notice
is not adequate and describes such further information or
action that is required for acceptance of such change. If the
Secretary notifies the holder that a supplemental application
is required, the Secretary shall review the supplement within
135 days after the receipt of the supplement. The time used by
the Secretary to review the notice of the manufacturing change
shall be deducted from the 135-day review period if the notice
meets appropriate content requirements for premarket approval
supplements.
(B)(i) Subject to clause (ii), in reviewing a supplement to
an approved application, for an incremental change to the
design of a device that affects safety or effectiveness, the
Secretary shall approve such supplement if--
(I) nonclinical data demonstrate that the design
modification creates the intended additional capacity,
function, or performance of the device; and
(II) clinical data from the approved application and
any supplement to the approved application provide a
reasonable assurance of safety and effectiveness for
the changed device.
(ii) The Secretary may require, when necessary, additional
clinical data to evaluate the design modification of the device
to provide a reasonable assurance of safety and effectiveness.
Withdrawal and Temporary Suspension of Approval of Application
(e)(1) The Secretary shall, upon obtaining, where
appropriate, advice on scientific matters from a panel or
panels under section 513, and after due notice and opportunity
for informal hearing to the holder of an approved application
for a device, issue an order withdrawing approval of the
application if the Secretary finds--
(A) that such device is unsafe or ineffective under
the conditions of use prescribed, recommended, or
suggested in the labeling thereof;
(B) on the basis of new information before him with
respect to such device, evaluated together with the
evidence available to him when the application was
approved, that there is a lack of a showing of
reasonable assurance that the device is safe or
effective under the conditions of use prescribed,
recommended, or suggested in the labeling thereof;
(C) that the application contained or was accompanied
by an untrue statement of a material fact;
(D) that the applicant (i) has failed to establish a
system for maintaining records, or has repeatedly or
deliberately failed to maintain records or to make
reports, required by an applicable regulation under
section 519(a), (ii) has refused to permit access to,
or copying or verification of, such records as required
by section 704, or (iii) has not complied with the
requirements of section 510;
(E) on the basis of new information before him with
respect to such device, evaluated together with the
evidence before him when the application was approved,
that the methods used in, or the facilities and
controls used for, the manufacture, processing,
packing, or installation of such device do not conform
with the requirements of section 520(f) and were not
brought into conformity with such requirements within a
reasonable time after receipt of written notice from
the Secretary of nonconformity;
(F) on the basis of new information before him,
evaluated together with the evidence before him when
the application was approved, that the labeling of such
device, based on a fair evaluation of all material
facts, is false or misleading in any particular and was
not corrected within a reasonable time after receipt of
written notice from the Secretary of such fact; or
(G) on the basis of new information before him,
evaluated together with the evidence before him when
the application was approved, that such device is not
shown to conform in all respects to a performance
standard which is in effect under section 514
compliance with which was a condition to approval of
the application and that there is a lack of adequate
information to justify the deviation from such
standard.
(2) The holder of an application subject to an order issued
under paragraph (1) withdrawing approval of the application
may, by petition filed on or before the thirtieth day after the
date upon which he receives notice of such withdrawal, obtain
review thereof in accordance with either paragraph (1) or (2)
of subsection (g).
(3) If, after providing an opportunity for an informal
hearing, the Secretary determines there is reasonable
probability that the continuation of distribution of a device
under an approved application would cause serious, adverse
health consequences or death, the Secretary shall by order
temporarily suspend the approval of the application approved
under this section. If the Secretary issues such an order, the
Secretary shall proceed expeditiously under paragraph (1) to
withdraw such application.
Product Development Protocol
(f)(1) In the case of a class III device which is required to
have an approval of an application submitted under subsection
(c), such device shall be considered as having such an approval
if a notice of completion of testing conducted in accordance
with a product development protocol approved under paragraph
(4) has been declared completed under paragraph (6).
(2) Any person may submit to the Secretary a proposed product
development protocol with respect to a device. Such a protocol
shall be accompanied by data supporting it. If, within thirty
days of the receipt of such a protocol, the Secretary
determines that it appears to be appropriate to apply the
requirements of this subsection to the device with respect to
which the protocol is submitted, the Secretary--
(A) may, at the initiative of the Secretary, refer
the proposed protocol to the appropriate panel under
section 513 for its recommendation respecting approval
of the protocol; or
(B) shall so refer such protocol upon the request of
the submitter, unless the Secretary finds that the
proposed protocol and accompanying data which would be
reviewed by such panel substantially duplicate a
product development protocol and accompanying data
which have previously been reviewed by such a panel.
(3) A proposed product development protocol for a device may
be approved only if--
(A) the Secretary determines that it is appropriate
to apply the requirements of this subsection to the
device in lieu of the requirement of approval of an
application submitted under subsection (c); and
(B) the Secretary determines that the proposed
protocol provides--
(i) a description of the device and the
changes which may be made in the device,
(ii) a description of the preclinical trials
(if any) of the device and a specification of
(I) the results from such trials to be required
before the commencement of clinical trials of
the device, and (II) any permissible variations
in preclinical trials and the results
therefrom,
(iii) a description of the clinical trials
(if any) of the device and a specification of
(I) the results from such trials to be required
before the filing of a notice of completion of
the requirements of the protocol, and (II) any
permissible variations in such trials and the
results therefrom,
(iv) a description of the methods to be used
in, and the facilities and controls to be used
for, the manufacture, processing, and when
relevant, packing and installation of the
device,
(v) an identifying reference to any
performance standard under section 514 to be
applicable to any aspect of such device,
(vi) if appropriate, specimens of the
labeling proposed to be used for such device,
(vii) such other information relevant to the
subject matter of the protocol as the
Secretary, with the concurrence of the
appropriate panel or panels under section 513,
may require, and
(viii) a requirement for submission of
progress reports and, when completed, records
of the trials conducted under the protocol
which records are adequate to show compliance
with the protocol.
(4) The Secretary shall approve or disapprove a proposed
product development protocol submitted under paragraph (2)
within one hundred and twenty days of its receipt unless an
additional period is agreed upon by the Secretary and the
person who submitted the protocol. Approval of a protocol or
denial of approval of a protocol is final agency action subject
to judicial review under chapter 7 of title 5, United States
Code.
(5) At any time after a product development protocol for a
device has been approved pursuant to paragraph (4), the person
for whom the protocol was approved may submit a notice of
completion--
(A) stating (i) his determination that the
requirements of the protocol have been fulfilled and
that, to the best of his knowledge, there is no reason
bearing on safety or effectiveness why the notice of
completion should not become effective, and (ii) the
data and other information upon which such
determination was made, and
(B) setting forth the results of the trials required
by the protocol and all the information required by
subsection (c)(1).
(6)(A) The Secretary may, after providing the person who has
an approved protocol an opportunity for an informal hearing and
at any time prior to receipt of notice of completion of such
protocol, issue a final order to revoke such protocol if he
finds that--
(i) such person has failed substantially to comply
with the requirements of the protocol,
(ii) the results of the trials obtained under the
protocol differ so substantially from the results
required by the protocol that further trials cannot be
justified, or
(iii) the results of the trials conducted under the
protocol or available new information do not
demonstrate that the device tested under the protocol
does not present an unreasonable risk to health and
safety.
(B) After the receipt of a notice of completion of an
approved protocol the Secretary shall, within the ninety-day
period beginning on the date such notice is received, by order
either declare the protocol completed or declare it not
completed. An order declaring a protocol not completed may take
effect only after the Secretary has provided the person who has
the protocol opportunity for an informal hearing on the order.
Such an order may be issued only if the Secretary finds--
(i) such person has failed substantially to comply
with the requirements of the protocol,
(ii) the results of the trials obtained under the
protocol differ substantially from the results required
by the protocol, or
(iii) there is a lack of a showing of reasonable
assurance of the safety and effectiveness of the device
under the conditions of use prescribed, recommended, or
suggested in the proposed labeling thereof.
(C) A final order issued under subparagraph (A) or (B) shall
be in writing and shall contain the reasons to support the
conclusions thereof.
(7) At any time after a notice of completion has become
effective, the Secretary may issue an order (after due notice
and opportunity for an informal hearing to the person for whom
the notice is effective) revoking the approval of a device
provided by a notice of completion which has become effective
as provided in subparagraph (B) if he finds that any of the
grounds listed in subparagraphs (A) through (G) of subsection
(e)(1) of this section apply. Each reference in such
subparagraphs to an application shall be considered for
purposes of this paragraph as a reference to a protocol and the
notice of completion of such protocol, and each reference to
the time when an application was approved shall be considered
for purposes of this paragraph as a reference to the time when
a notice of completion took effect.
(8) A person who has an approved protocol subject to an order
issued under paragraph (6)(A) revoking such protocol, a person
who has an approved protocol with respect to which an order
under paragraph (6)(B) was issued declaring that the protocol
had not been completed, or a person subject to an order issued
under paragraph (7) revoking the approval of a device may, by
petition filed on or before the thirtieth day after the date
upon which he receives notice of such order, obtain review
thereof in accordance with either paragraph (1) or (2) of
subsection (g).
Review
(g)(1) Upon petition for review of--
(A) an order under subsection (d) approving or
denying approval of an application or an order under
subsection (e) withdrawing approval of an application,
or
(B) an order under subsection (f)(6)(A) revoking an
approved protocol, under subsection (f)(6)(B) declaring
that an approved protocol has not been completed, or
under subsection (f)(7) revoking the approval of a
device,
the Secretary shall, unless he finds the petition to be without
good cause or unless a petition for review of such order has
been submitted under paragraph (2), hold a hearing, in
accordance with section 554 of title 5 of the United States
Code, on the order. The panel or panels which considered the
application, protocol, or device subject to such order shall
designate a member to appear and testify at any such hearing
upon request of the Secretary, the petitioner, or the officer
conducting the hearing, but this requirement does not preclude
any other member of the panel or panels from appearing and
testifying at any such hearing. Upon completion of such hearing
and after considering the record established in such hearing,
the Secretary shall issue an order either affirming the order
subject to the hearing or reversing such order and, as
appropriate, approving or denying approval of the application,
reinstating the application's approval, approving the protocol,
or placing in effect a notice of completion.
(2)(A) Upon petition for review of--
(i) an order under subsection (d) approving or
denying approval of an application or an order under
subsection (e) withdrawing approval of an application,
or
(ii) an order under subsection (f)(6)(A) revoking an
approved protocol, under subsection (f)(6)(B) declaring
that an approved protocol has not been completed, or
under subsection (f)(7) revoking the approval of a
device,
the Secretary shall refer the application or protocol subject
to the order and the basis for the order to an advisory
committee of experts established pursuant to subparagraph (B)
for a report and recommendation with respect to the order. The
advisory committee shall, after independent study of the data
and information furnished to it by the Secretary and other data
and information before it, submit to the Secretary a report and
recommendation, together with all underlying data and
information and a statement of the reasons or basis for the
recommendation. A copy of such report shall be promptly
supplied by the Secretary to any person who petitioned for such
referral to the advisory committee.
(B) The Secretary shall establish advisory committees (which
may not be panels under section 513) to receive referrals under
subparagraph (A). The Secretary shall appoint as members of any
such advisory committee persons qualified in the subject matter
to be referred to the committee and of appropriately
diversified professional backgrounds, except that the Secretary
may not appoint to such a committee any individual who is in
the regular full-time employ of the United States and engaged
in the administration of this Act. Members of an advisory
committee (other than officers or employees of the United
States), while attending conferences or meetings of their
committee or otherwise serving at the request of the Secretary,
shall be entitled to receive compensation at rates to be fixed
by the Secretary which rates may not exceed the daily
equivalent for grade GS-18 of the General Schedule for each day
(including traveltime) they are so engaged; and while so
serving away from their homes or regular places of business
each member may be allowed travel expenses, including per diem
in lieu of subsistence, as authorized by section 5703 of title
5 of the United States Code for persons in the Government
service employed intermittently. The Secretary shall designate
the chairman of an advisory committee from its members. The
Secretary shall furnish each advisory committee with clerical
and other assistance, and shall by regulation prescribe the
procedures to be followed by each such committee in acting on
referrals made under subparagraph (A).
(C) The Secretary shall make public the report and
recommendation made by an advisory committee with respect to an
application and shall by order, stating the reasons therefor,
either affirm the order referred to the advisory committee or
reverse such order and, if appropriate, approve or deny
approval of the application, reinstate the application's
approval, approve the protocol, or place in effect a notice of
completion.
Service of Orders
(h) Orders of the Secretary under this section shall be
served (1) in person by any officer or employee of the
department designated by the Secretary, or (2) by mailing the
order by registered mail or certified mail addressed to the
applicant at his last known address in the records of the
Secretary.
Revision
(i)(1) Before December 1, 1995, the Secretary shall by order
require manufacturers of devices, which were introduced or
delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, and which are
subject to revision of classification under paragraph (2), to
submit to the Secretary a summary of and citation to any
information known or otherwise available to the manufacturer
respecting such devices, including adverse safety or
effectiveness information which has not been submitted under
section 519. The Secretary may require the manufacturer to
submit the adverse safety or effectiveness data for which a
summary and citation were submitted, if such data are available
to the manufacturer.
(2) After the issuance of an order under paragraph (1) but
before the date that is 2 years after the date of enactment of
the Food and Drug Administration Safety and Innovation Act, the
Secretary shall 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, for each device--
(A) which the Secretary has classified as a class III
device, and
(B) for which no administrative order has been issued
under subsection (b) (or no regulation has been
promulgated under such subsection prior to the date of
enactment of the Food and Drug Administration Safety
and Innovation Act),
revising the classification of the device so that the device is
classified into class I or class II, unless the administrative
order issued under this paragraph requires the device to remain
in class III. In determining whether to revise the
classification of a device or to require a device to remain in
class III, the Secretary shall apply the criteria set forth in
section 513(a).
(3) The Secretary shall, as promptly as is reasonably
achievable, but not later than 12 months after the effective
date of the order requiring a device to remain in class III,
establish a schedule for the issuance of an administrative
order under subsection (b) for each device which is subject to
the order requiring the device to remain in class III.
* * * * * * *
SEC. [515C.] 515B. BREAKTHROUGH DEVICES.
(a) Purpose.--The purpose of this section is to encourage the
Secretary, and provide the Secretary with sufficient authority,
to apply efficient and flexible approaches to expedite the
development of, and prioritize the Food and Drug
Administration's review of, devices that represent breakthrough
technologies.
(b) Establishment of Program.--The Secretary shall establish
a program to expedite the development of, and provide for the
priority review for, devices, as determined by the Secretary--
(1) that provide for more effective treatment or
diagnosis of life-threatening or irreversibly
debilitating human disease or conditions; and
(2)(A) that represent breakthrough technologies;
(B) for which no approved or cleared alternatives
exist;
(C) that offer significant advantages over existing
approved or cleared alternatives, including the
potential, compared to existing approved alternatives,
to reduce or eliminate the need for hospitalization,
improve patient quality of life, facilitate patients'
ability to manage their own care (such as through self-
directed personal assistance), or establish long-term
clinical efficiencies; or
(D) the availability of which is in the best interest
of patients.
(c) Request for Designation.--A sponsor of a device may
request that the Secretary designate such device for expedited
development and priority review under this section. Any such
request for designation may be made at any time prior to the
submission of an application under section 515(c), a
notification under section 510(k), or a petition for
classification under section 513(f)(2).
(d) Designation Process.--
(1) In general.--Not later than 60 calendar days
after the receipt of a request under subsection (c),
the Secretary shall determine whether the device that
is the subject of the request meets the criteria
described in subsection (b). If the Secretary
determines that the device meets the criteria, the
Secretary shall designate the device for expedited
development and priority review.
(2) Review.--Review of a request under subsection (c)
shall be undertaken by a team that is composed of
experienced staff and senior managers of the Food and
Drug Administration.
(3) Withdrawal.--The Secretary may not withdraw a
designation granted under this section on the basis of
the criteria under subsection (b) no longer applying
because of the subsequent clearance or approval of
another device that--
(A) was designated under this section; or
(B) was given priority review under section
515(d)(5), as in effect prior to the date of
enactment of the 21st Century Cures Act.
(e) Expedited Development and Priority Review.--
(1) Actions.--For purposes of expediting the
development and review of devices designated under
subsection (d) the Secretary shall--
(A) assign a team of staff, including a team
leader with appropriate subject matter
expertise and experience, for each device for
which a request is submitted under subsection
(c);
(B) provide for oversight of the team by
senior agency personnel to facilitate the
efficient development of the device and the
efficient review of any submission described in
subsection (c) for the device;
(C) adopt an efficient process for timely
dispute resolution;
(D) provide for interactive and timely
communication with the sponsor of the device
during the development program and review
process;
(E) expedite the Secretary's review of
manufacturing and quality systems compliance,
as applicable;
(F) disclose to the sponsor, not less than 5
business days in advance, the topics of any
consultation the Secretary intends to undertake
with external experts or an advisory committee
concerning the sponsor's device and provide the
sponsor the opportunity to recommend such
external experts;
(G) provide for advisory committee input, as
the Secretary determines appropriate (including
in response to the request of the sponsor) for
applications submitted under section 515(c);
and
(H) assign staff to be available within a
reasonable time to address questions by
institutional review committees concerning the
conditions and clinical testing requirements
applicable to the investigational use of the
device pursuant to an exemption under section
520(g).
(2) Additional actions.--In addition to the actions
described in paragraph (1), for purposes of expediting
the development and review of devices designated under
subsection (d), the Secretary, in collaboration with
the device sponsor, may, as appropriate--
(A) coordinate with the sponsor regarding
early agreement on a data development plan;
(B) take steps to ensure that the design of
clinical trials is as efficient and flexible as
practicable, when scientifically appropriate;
(C) facilitate, when scientifically
appropriate, expedited and efficient
development and review of the device through
utilization of timely postmarket data
collection with regard to application for
approval under section 515(c); and
(D) agree in writing to clinical protocols
that the Secretary will consider binding on the
Secretary and the sponsor, subject to--
(i) changes to such protocols agreed
to in writing by the sponsor and the
Secretary; or
(ii) a decision, made by the director
of the office responsible for reviewing
the device submission, that a
substantial scientific issue essential
to determining the safety or
effectiveness of such device exists,
provided that such decision is in
writing, and is made only after the
Secretary provides to the device
sponsor or applicant an opportunity for
a meeting at which the director and the
sponsor or applicant are present and at
which the director documents the
substantial scientific issue.
(f) Priority Review Guidance.--
(1) Content.--Not later than 1 year after the date of
enactment of the 21st Century Cures Act, the Secretary
shall issue guidance on the implementation of this
section. Such guidance shall--
(A) set forth the process by which a person
may seek a designation under subsection (d);
(B) provide a template for requests under
subsection (c);
(C) identify the criteria the Secretary will
use in evaluating a request for designation
under this section; and
(D) identify the criteria and processes the
Secretary will use to assign a team of staff,
including team leaders, to review devices
designated for expedited development and
priority review, including any training
required for such personnel to ensure effective
and efficient review.
(2) Process.--Prior to finalizing the guidance under
paragraph (1), the Secretary shall seek public comment
on [a proposed guidance] a draft version of that
guidance.
(g) Rule of Construction.--Nothing in this section shall be
construed to affect--
(1) the criteria and standards for evaluating an
application pursuant to section 515(c), a report and
request for classification under section 513(f)(2), or
a report under section 510(k), including the
recognition of valid scientific evidence as described
in section 513(a)(3)(B) and consideration and
application of the least burdensome means of evaluating
device effectiveness or demonstrating substantial
equivalence between devices with differing
technological characteristics, as applicable;
(2) the authority of the Secretary with respect to
clinical holds under section 520(g)(8)(A);
(3) the authority of the Secretary to act on an
application pursuant to section 515(d) before
completion of an establishment inspection, as the
Secretary determines appropriate; or
(4) the authority of the Secretary with respect to
postmarket surveillance under sections 519(h) and 522.
* * * * * * *
records and reports on devices
General Rule
Sec. 519. (a) Every person who is a manufacturer or importer
of a device intended for human use shall establish and maintain
such records, make such reports, and provide such information,
as the Secretary may by regulation reasonably require to assure
that such device is not adulterated or misbranded and to
otherwise assure its safety and effectiveness. Regulations
prescribed under the preceding sentence--
(1) shall require a device manufacturer or importer
to report to the Secretary whenever the manufacturer or
importer receives or otherwise becomes aware of
information that reasonably suggests that one of its
marketed devices--
(A) may have caused or contributed to a death
or serious injury, or
(B) has malfunctioned and that such device or
a similar device marketed by the manufacturer
or importer would be likely to cause or
contribute to a death or serious injury if the
malfunction were to recur, which report under
this subparagraph--
(i) shall be submitted in accordance
with part 803 of title 21, Code of
Federal Regulations (or successor
regulations), unless the Secretary
grants an exemption or variance from,
or an alternative to, a requirement
under such regulations pursuant to
section 803.19 of such part, if the
device involved is--
(I) a class III device;
(II) a class II device that
is permanently implantable, is
life supporting, or is life
sustaining; or
(III) a type of device which
the Secretary has, by notice
published in the Federal
Register or letter to the
person who is the manufacturer
or importer of the device,
indicated should be subject to
such part 803 in order to
protect the public health;
(ii) shall, if the device is not
subject to clause (i), be submitted in
accordance with criteria established by
the Secretary for reports made pursuant
to this clause, which criteria shall
require the reports to be in summary
form and made on a quarterly basis; or
(iii) shall, if the device is
imported into the United States and for
which part 803 of title 21, Code of
Federal Regulations (or successor
regulations) requires an importer to
submit a report to the manufacturer, be
submitted by the importer to the
manufacturer in accordance with part
803 of title 21, Code of Federal
Regulations (or successor regulations)
(2) shall define the term ``serious injury'' to mean
an injury that--
(A) is life threatening,
(B) results in permanent impairment of a body
function or permanent damage to a body
structure, or
(C) necessitates medical or surgical
intervention to preclude permanent impairment
of a body function or permanent damage to a
body structure;
(3) shall require reporting of other significant
adverse device experiences as determined by the
Secretary to be necessary to be reported;
(4) shall not impose requirements unduly burdensome
to a device manufacturer or importer taking into
account his cost of complying with such requirements
and the need for the protection of the public health
and the implementation of this Act;
(5) which prescribe the procedure for making requests
for reports or information shall require that each
request made under such regulations for submission of a
report or information to the Secretary state the reason
or purpose for such request and identify to the fullest
extent practicable such report or information;
(6) which require submission of a report or
information to the Secretary shall state the reason or
purpose for the submission of such report or
information and identify to the fullest extent
practicable such report or information;
(7) may not require that the identity of any patient
be disclosed in records, reports, or information
required under this subsection unless required for the
medical welfare of an individual, to determine the
safety or effectiveness of a device, or to verify a
record, report, or information submitted under this
Act; and
(8) may not require a manufacturer or importer of a
class I device to--
(A) maintain for such a device records
respecting information not in the possession of
the manufacturer or importer, or
(B) to submit for such a device to the
Secretary any report or information--
(i) not in the possession of the
manufacturer or importer, or
(ii) on a periodic basis,
unless such report or information is necessary to
determine if the device should be reclassified or if
the device is adulterated or misbranded. and
In prescribing such regulations, the Secretary shall have due
regard for the professional ethics of the medical profession
and the interests of patients. The prohibitions of paragraph
(7) of this subsection continue to apply to records, reports,
and information concerning any individual who has been a
patient, irrespective of whether or when he ceases to be a
patient. The Secretary shall by regulation require distributors
to keep records and make such records available to the
Secretary upon request. Paragraphs (4) and (8) apply to
distributors to the same extent and in the same manner as such
paragraphs apply to manufacturers and importers.
User Reports
(b)(1)(A) Whenever a device user facility receives or
otherwise becomes aware of information that reasonably suggests
that a device has or may have caused or contributed to the
death of a patient of the facility, the facility shall, as soon
as practicable but not later than 10 working days after
becoming aware of the information, report the information to
the Secretary and, if the identity of the manufacturer is
known, to the manufacturer of the device. In the case of
deaths, the Secretary may by regulation prescribe a shorter
period for the reporting of such information.
(B) Whenever a device user facility receives or otherwise
becomes aware of--
(i) information that reasonably suggests that a
device has or may have caused or contributed to the
serious illness of, or serious injury to, a patient of
the facility, or
(ii) other significant adverse device experiences as
determined by the Secretary by regulation to be
necessary to be reported,
shall, as soon as practicable but not later than 10 working
days after becoming aware of the information, report the
information to the manufacturer of the device or to the
Secretary if the identity of the manufacturer is not known.
(C) Each device user facility shall submit to the Secretary
on an annual basis a summary of the reports made under
subparagraphs (A) and (B). Such summary shall be submitted on
January 1 of each year. The summary shall be in such form and
contain such information from such reports as the Secretary may
require and shall include--
(i) sufficient information to identify the facility
which made the reports for which the summary is
submitted,
(ii) in the case of any product which was the subject
of a report, the product name, serial number, and model
number,
(iii) the name and the address of the manufacturer of
such device, and
(iv) a brief description of the event reported to the
manufacturer.
(D) For purposes of subparagraphs (A), (B), and (C), a device
user facility shall be treated as having received or otherwise
become aware of information with respect to a device of that
facility when medical personnel who are employed by or
otherwise formally affiliated with the facility receive or
otherwise become aware of information with respect to that
device in the course of their duties.
(2) The Secretary may not disclose the identity of a device
user facility which makes a report under paragraph (1) except
in connection with--
(A) an action brought to enforce section 301(q), or
(B) a communication to a manufacturer of a device
which is the subject of a report under paragraph (1).
This paragraph does not prohibit the Secretary from disclosing
the identity of a device user facility making a report under
paragraph (1) or any information in such a report to employees
of the Department of Health and Human Services, to the
Department of Justice, or to the duly authorized committees and
subcommittees of the Congress.
(3) No report made under paragraph (1) by--
(A) a device user facility,
(B) an individual who is employed by or otherwise
formally affiliated with such a facility, or
(C) a physician who is not required to make such a
report,
shall be admissible into evidence or otherwise used in any
civil action involving private parties unless the facility,
individual, or physician who made the report had knowledge of
the falsity of the information contained in the report.
(4) A report made under paragraph (1) does not affect any
obligation of a manufacturer who receives the report to file a
report as required under subsection (a).
(5) With respect to device user facilities:
(A) The Secretary shall by regulation plan and
implement a program under which the Secretary limits
user reporting under paragraphs (1) through (4) to a
subset of user facilities that constitutes a
representative profile of user reports for device
deaths and serious illnesses or serious injuries.
(B) During the period of planning the program under
subparagraph (A), paragraphs (1) through (4) continue
to apply.
(C) During the period in which the Secretary is
providing for a transition to the full implementation
of the program, paragraphs (1) through (4) apply except
to the extent that the Secretary determines otherwise.
(D) On and after the date on which the program is
fully implemented, paragraphs (1) through (4) do not
apply to a user facility unless the facility is
included in the subset referred to in subparagraph (A).
(E) Not later than 2 years after the date of the
enactment of the Food and Drug Administration
Modernization Act of 1997, the Secretary shall submit
to the Committee on Commerce of the House of
Representatives, and to the Committee on Labor and
Human Resources of the Senate, a report describing the
plan developed by the Secretary under subparagraph (A)
and the progress that has been made toward the
implementation of the plan.
(6) For purposes of this subsection:
(A) The term ``device user facility'' means a
hospital, ambulatory surgical facility, nursing home,
or outpatient treatment facility which is not a
physician's office. The Secretary may by regulation
include an outpatient diagnostic facility which is not
a physician's office in such term.
(B) The terms ``serious illness'' and ``serious
injury'' mean illness or injury, respectively, that--
(i) is life threatening,
(ii) results in permanent impairment of a
body function or permanent damage to a body
structure, or
(iii) necessitates medical or surgical
intervention to preclude permanent impairment
of a body function or permanent damage to a
body structure.
Persons Exempt
(c) Subsection (a) shall not apply to--
(1) any practitioner who is licensed by law to
prescribe or administer devices intended for use in
humans and who manufactures or imports devices solely
for use in the course of his professional practice;
(2) any person who manufactures or imports devices
intended for use in humans solely for such person's use
in research or teaching and not for sale (including any
person who uses a device under an exemption granted
under section 520(g)); and
(3) any other class of persons as the Secretary may
by regulation exempt from subsection (a) upon a finding
that compliance with the requirements of such
subsection by such class with respect to a device is
not necessary to (A) assure that a device is not
adulterated or misbranded or (B) otherwise to assure
its safety and effectiveness.
Device Tracking
(e)(1) The Secretary may by order require a manufacturer to
adopt a method of tracking a class II or class III device--
(A) the failure of which would be reasonably likely
to have serious adverse health consequences; or
(B) which is--
(i) intended to be implanted in the human
body for more than one year, or
(ii) a life sustaining or life supporting
device used outside a device user facility.
(2) Any patient receiving a device subject to tracking under
paragraph (1) may refuse to release, or refuse permission to
release, the patient's name, address, social security number,
or other identifying information for the purpose of tracking.
Unique Device Identification System
(f) Not later than December 31, 2012, the Secretary shall
issue proposed regulations establishing a unique device
identification system for medical devices requiring the label
of devices to bear a unique identifier, unless the Secretary
requires an alternative placement or provides an exception for
a particular device or type of device. The unique identifier
shall adequately identify the device through distribution and
use, and may include information on the lot or serial number.
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, or life sustaining not later than
2 years after the regulations are finalized, taking into
account patient access to medical devices and therapies.
Reports of Removals and Corrections
(g)(1) Except as provided in paragraph (2), the Secretary
shall by regulation require a manufacturer or importer of a
device to report promptly to the Secretary any correction or
removal of a device undertaken by such manufacturer or importer
if the removal or correction was undertaken--
(A) to reduce a risk to health posed by the device,
or
(B) to remedy a violation of this Act caused by the
device which may present a risk to health.
A manufacturer or importer of a device who undertakes a
correction or removal of a device which is not required to be
reported under this paragraph shall keep a record of such
correction or removal.
(2) No report of the corrective action or removal of a device
may be required under paragraph (1) if a report of the
corrective action or removal is required and has been submitted
under subsection (a).
(3) For purposes of paragraphs (1) and (2), the terms
``correction'' and ``removal'' do not include routine
servicing.
(h) Inclusion of Devices in the Postmarket Risk
Identification and Analysis System.--
(1) In general.--
(A) Application to devices.--The Secretary
shall amend the procedures established and
maintained under clauses (i), (ii), (iii), and
(v) of section 505(k)(3)(C) in order to expand
the postmarket risk identification and analysis
system established under such section to
include and apply to devices.
(B) Exception.--Subclause (II) of clause (i)
of section 505(k)(3)(C) shall not apply to
devices.
(C) Clarification.--With respect to devices,
the private sector health-related electronic
data provided under section
505(k)(3)(C)(i)(III)(bb) may include medical
device utilization data, health insurance
claims data, and procedure and device
registries.
(2) Data.--In expanding the system as described in
paragraph (1)(A), the Secretary shall use relevant data
with respect to devices cleared under section 510(k) or
approved under section 515, including claims data,
patient survey data, and any other data deemed
appropriate by the Secretary.
(3) Stakeholder input.--To help ensure effective
implementation of the system as described in paragraph
(1) with respect to devices, the Secretary shall engage
outside stakeholders in development of the system, and
gather information from outside stakeholders regarding
the content of an effective sentinel program, through a
public hearing, advisory committee meeting, maintenance
of a public docket, or other similar public measures.
(4) Voluntary surveys.--Chapter 35 of title 44,
United States Code, shall not apply to the collection
of voluntary information from health care providers,
such as voluntary surveys or questionnaires, initiated
by the Secretary for purposes of postmarket risk
identification, mitigation, and analysis for devices.
(i) Pilot Projects To Generate Reliable and Timely Safety and
Active Surveillance Data.--
(1) In general.--The Secretary shall, not later than
one year after the date of the enactment of the FDA
Reauthorization Act of 2017, initiate one or more pilot
projects relating to providing timely and reliable
information on the safety and effectiveness of devices
approved under section 515, cleared under section
510(k), or classified under section 513(f)(2), in which
a manufacturer or manufacturers of a device or device
type voluntarily participate. Any such project shall
meet each of the following criteria:
(A) The project is designed to efficiently
generate reliable and timely safety and active
surveillance data for use by the Secretary or
manufacturers of the devices that are involved
in the pilot project.
(B) The project informs, to the extent
applicable, the development of methods,
systems, data criteria, and programs that could
be used to support safety and active
surveillance activities for any device.
(C) The project shall be designed and
conducted in coordination with a comprehensive
system for evaluating device technology that
operates under a governing board with
appropriate representation of stakeholders,
including patient groups and device
manufacturers.
(D) The project uses electronic health data
including, as appropriate, claims data, patient
survey data, and any other data, as the
Secretary determines appropriate.
(E) The project prioritizes devices and
device types that meet one or more of the
following criteria:
(i) Devices and device types for
which the collection and analysis of
real world evidence regarding a
device's safety and effectiveness is
likely to advance public health.
(ii) Devices and device types that
are widely used.
(iii) Devices and device types, the
failure of which has significant health
consequences.
(iv) Devices and device types for
which the Secretary--
(I) has received public
recommendations in accordance
with paragraph (2)(B); and
(II) has determined to meet
one of the criteria under
clause (i), (ii), or (iii) and
is appropriate for such a pilot
project.
(2) Participation.--The Secretary shall establish the
conditions and processes--
(A) under which a manufacturer of a device
may voluntarily participate in a pilot project
described in paragraph (1); and
(B) for facilitating public recommendations
for devices to be prioritized under such a
pilot project, including requirements for the
data necessary to support such a
recommendation.
(3) Continuation of ongoing projects.--The Secretary
may continue or expand projects, with respect to
providing timely and reliable information on the safety
and effectiveness of devices approved under section
515, cleared under section 510(k), or classified under
section 513(f)(2), that are being carried out as of the
date of the enactment of the FDA Reauthorization Act of
2017. The Secretary shall, beginning on such date of
enactment, take such steps as may be necessary--
(A) to ensure such projects meet the
requirements of subparagraphs (A) through (E)
of paragraph (1); and
(B) to increase the voluntary participation
in such projects of manufacturers of devices
and facilitate public recommendations for any
devices prioritized under such a project.
(4) Implementation.--
(A) Contracting authority.--The Secretary may
carry out a pilot project meeting the criteria
specified in subparagraphs (A) through (E) of
paragraph (1) or a project continued or
expanded under paragraph (3) by entering into
contracts, cooperative agreements, grants, or
other appropriate agreements with public or
private entities that have a significant
presence in the United States and meet the
following conditions:
(i) If such an entity is a component
of another organization, the entity and
the organization have established an
agreement under which appropriate
security measures are implemented to
maintain the confidentiality and
privacy of the data described in
paragraph (1)(D) and such agreement
ensures that the entity will not make
an unauthorized disclosure of such data
to the other components of the
organization in breach of requirements
with respect to confidentiality and
privacy of such data established under
such security measures.
(ii) In the case of the termination
or nonrenewal of such a contract,
cooperative agreement, grant, or other
appropriate agreement, the entity or
entities involved shall comply with
each of the following:
(I) The entity or entities
shall continue to comply with
the requirements with respect
to confidentiality and privacy
referred to in clause (i) under
this subparagraph with respect
to all data disclosed to the
entity under such an agreement.
(II) The entity or entities
shall return any data disclosed
to such entity pursuant to this
subsection and to which it
would not otherwise have access
or, if returning such data is
not practicable, destroy the
data.
(iii) The entity or entities shall
have one or more qualifications with
respect to--
(I) research, statistical,
epidemiologic, or clinical
capability and expertise to
conduct and complete the
activities under this
subsection, including the
capability and expertise to
provide the Secretary access to
de-identified data consistent
with the requirements of this
subsection;
(II) an information
technology infrastructure to
support electronic data and
operational standards to
provide security for such data,
as appropriate;
(III) experience with, and
expertise on, the development
of research on, and
surveillance of, device safety
and effectiveness using
electronic health data; or
(IV) such other expertise
which the Secretary determines
necessary to carry out such a
project.
(B) Review of contract in the event of a
merger or acquisition.--The Secretary shall
review any contract, cooperative agreement,
grant, or other appropriate agreement entered
into under this paragraph with an entity
meeting the conditions specified in
subparagraph (A) in the event of a merger or
acquisition of the entity in order to ensure
that the requirements specified in this
subsection will continue to be met.
(5) Compliance with requirements for records or
reports on devices.--The participation of a
manufacturer in pilot projects under this subsection
shall not affect the eligibility of such manufacturer
to participate in any quarterly reporting program with
respect to devices carried out under section 519 or
522. The Secretary may determine that, for a specified
time period to be determined by the Secretary, a
manufacturer's participation in a pilot project under
this subsection or a project continued or expanded
under paragraph (3) may meet the applicable
requirements of section 519 or 522, if--
(A) the project has demonstrated success in
capturing relevant adverse event information;
and
(B) the Secretary has established procedures
for making adverse event and safety information
collected from such project public, to the
extent possible.
(6) Privacy requirements.--With respect to the
disclosure of any health information collected through
a project conducted under this subsection--
(A) individually identifiable health
information so collected shall not be disclosed
when presenting any information from such
project; and
(B) any such disclosure shall be made in
compliance with regulations issued pursuant to
section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (42
U.S.C. 1320d-2 note) and sections 552 and 552a
of title 5, United States Code.
(7) Limitations.--
(A) In general.--No pilot project under this
subsection undertaken in coordination with the
comprehensive system described in paragraph
(1)(C), shall allow for an entity participating
in such program, other than the Secretary or
the Secretary's designee, to make
determinations of safety or effectiveness, or
substantial equivalence, for purposes of the
Act.
(B) No use of fees.--Pilot projects initiated
under this subsection may not primarily utilize
funds collected pursuant to the Medical Device
User Fee Amendments of 2017.
(8) Other projects required to comply.--Paragraphs
(1)(B), (4)(A)(i), (4)(A)(ii), (5), and (6) shall apply
with respect to any pilot program undertaken in
coordination with the comprehensive system described in
paragraph (1)(C) that relates to the use of real world
evidence for devices in the same manner and to the same
extent as such paragraphs apply with respect to pilot
projects conducted under this subsection.
(9) Report to congress.--Not later than 18 months
after the date of enactment of this Act, and annually
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 containing a
description of the pilot projects being conducted under
this subsection and projects continued or expanded
pursuant to paragraph (3), including for each such
project--
(A) how the project is being implemented in
accordance with paragraph (4), including how
such project is being implemented through a
contract, cooperative agreement, grant, or
other appropriate agreement, if applicable;
(B) the number of manufacturers that have
agreed to participate in such project;
(C) the data sources used to conduct such
project;
(D) the devices or device categories involved
in such project;
(E) the number of patients involved in such
project; and
(F) the findings of the project in relation
to device safety, including adverse events,
malfunctions, and other safety information.
(10) Sunset.--The Secretary may not carry out a pilot
project initiated by the Secretary under this
subsection after October 1, 2022.
general provisions respecting control of devices intended for human use
General Rule
Sec. 520. (a) Any requirement authorized by or under section
501, 502, 510, or 519 applicable to a device intended for human
use shall apply to such device until the applicability of the
requirement to the device has been changed by action taken
under section 513, 514, or 515 or under subsection (g) of this
section, and any requirement established by or under section
501, 502, 510, or 519 which is inconsistent with a requirement
imposed on such device under section 514 or 515 or under
subsection (g) of this section shall not apply to such device.
(b) Custom Devices.--
(1) In general.--The requirements of sections 514 and
515 shall not apply to a device that--
(A) is created or modified in order to comply
with the order of an individual physician or
dentist (or any other specially qualified
person designated under regulations promulgated
by the Secretary after an opportunity for an
oral hearing);
(B) in order to comply with an order
described in subparagraph (A), necessarily
deviates from an otherwise applicable
performance standard under section 514 or
requirement under section 515;
(C) is not generally available in the United
States in finished form through labeling or
advertising by the manufacturer, importer, or
distributor for commercial distribution;
(D) is designed to treat a unique pathology
or physiological condition that no other device
is domestically available to treat;
(E)(i) is intended to meet the special needs
of such physician or dentist (or other
specially qualified person so designated) in
the course of the professional practice of such
physician or dentist (or other specially
qualified person so designated); or
(ii) is intended for use by an individual
patient named in such order of such physician
or dentist (or other specially qualified person
so designated);
(F) is assembled from components or
manufactured and finished on a case-by-case
basis to accommodate the unique needs of
individuals described in clause (i) or (ii) of
subparagraph (E); and
(G) may have common, standardized design
characteristics, chemical and material
compositions, and manufacturing processes as
commercially distributed devices.
(2) Limitations.--Paragraph (1) shall apply to a
device only if--
(A) such device is for the purpose of
treating a sufficiently rare condition, such
that conducting clinical investigations on such
device would be impractical;
(B) production of such device under paragraph
(1) is limited to no more than 5 units per year
of a particular device type, provided that such
replication otherwise complies with this
section; and
(C) the manufacturer of such device notifies
the Secretary on an annual basis, in a manner
prescribed by the Secretary, of the manufacture
of such device.
(3) Guidance.--Not later than 2 years after the date
of enactment of this section, the Secretary shall issue
final guidance on replication of multiple devices
described in paragraph (2)(B).
Trade Secrets
(c) Any information reported to or otherwise obtained by the
Secretary or his representative under section 513, 514, 515,
516, 518, 519, or 704 or under subsection (f) or (g) of this
section which is exempt from disclosure pursuant to subsection
(a) of section 552 of title 5, United States Code, by reason of
subsection (b)(4) of such section shall be considered
confidential and shall not be disclosed and may not be used by
the Secretary as the basis for the reclassification of a device
from class III to class II or class I or as the basis for the
establishment or amendment of a performance standard under
section 514 for a device reclassified from class III to class
II, except (1) in accordance with subsection (h), and (2) that
such information may be disclosed to other officers or
employees concerned with carrying out this Act or when relevant
in any proceeding under this Act (other than section 513 or 514
thereof).
Notices and Findings
(d) Each notice of proposed rulemaking under section 513,
514, 515, 516, 518, or 519, or under this section, any other
notice which is published in the Federal Register with respect
to any other action taken under any such section and which
states the reasons for such action, and each publication of
findings required to be made in connection with rulemaking
under any such section shall set forth--
(1) the manner in which interested persons may
examine data and other information on which the notice
or findings is based, and
(2) the period within which interested persons may
present their comments on the notice or findings
(including the need therefor) orally or in writing,
which period shall be at least sixty days but may not
exceed ninety days unless the time is extended by the
Secretary by a notice published in the Federal Register
stating good cause therefor.
Restricted Devices
(e)(1) The Secretary may by regulation require that a device
be restricted to sale, distribution, or use--
(A) only upon the written or oral authorization of a
practitioner licensed by law to administer or use such
device, or
(B) upon such other conditions as the Secretary may
prescribe in such regulation,
if, because of its potentiality for harmful effect or the
collateral measures necessary to its use, the Secretary
determines that there cannot otherwise be reasonable assurance
of its safety and effectiveness. No condition prescribed under
subparagraph (B) may restrict the use of a device to persons
with specific training or experience in its use or to persons
for use in certain facilities unless the Secretary determines
that such a restriction is required for the safe and effective
use of the device. No such condition may exclude a person from
using a device solely because the person does not have the
training or experience to make him eligible for certification
by a certifying board recognized by the American Board of
Medical Specialties or has not been certified by such a Board.
A device subject to a regulation under this subsection is a
restricted device.
(2) The label of a restricted device shall bear such
appropriate statements of the restrictions required by a
regulation under paragraph (1) as the Secretary may in such
regulation prescribe.
Good Manufacturing Practice Requirements
(f)(1)(A) The Secretary may, in accordance with subparagraph
(B), prescribe regulations requiring that the methods used in,
and the facilities and controls used for, the manufacture, pre-
production design validation (including a process to assess the
performance of a device but not including an evaluation of the
safety or effectiveness of a device), packing, storage, and
installation of a device conform to current good manufacturing
practice, as prescribed in such regulations, to assure that the
device will be safe and effective and otherwise in compliance
with this Act.
(B) Before the Secretary may promulgate any regulation under
subparagraph (A) he shall--
(i) afford the advisory committee established under
paragraph (3) an opportunity to submit recommendations
to him with respect to the regulation proposed to be
promulgated;
(ii) afford opportunity for an oral hearing; and
(iii) ensure that such regulation conforms, to the
extent practicable, with internationally recognized
standards defining quality systems, or parts of the
standards, for medical devices.
The Secretary shall provide the advisory committee a reasonable
time to make its recommendation with respect to proposed
regulations under subparagraph (A).
(2)(A) Any person subject to any requirement prescribed by
regulations under paragraph (1) may petition the Secretary for
an exemption or variance from such requirement. Such a petition
shall be submitted to the Secretary in such form and manner as
he shall prescribe and shall--
(i) in the case of a petition for an exemption from a
requirement, set forth the basis for the petitioner's
determination that compliance with the requirement is
not required to assure that the device will be safe and
effective and otherwise in compliance with this Act,
(ii) in the case of a petition for a variance from a
requirement, set forth the methods proposed to be used
in, and the facilities and controls proposed to be used
for, the manufacture, packing, storage, and
installation of the device in lieu of the methods,
facilities, and controls prescribed by the requirement,
and
(iii) contain such other information as the Secretary
shall prescribe.
(B) The Secretary may refer to the advisory committee
established under paragraph (3) any petition submitted under
subparagraph (A). The advisory committee shall report its
recommendations to the Secretary with respect to a petition
referred to it within sixty days of the date of the petition's
referral. Within sixty days after--
(i) the date the petition was submitted to the
Secretary under subparagraph (A), or
(ii) if the petition was referred to an advisory
committee, the expiration of the sixty-day period
beginning on the date the petition was referred to the
advisory committee,
whichever occurs later, the Secretary shall by order either
deny the petition or approve it.
(C) The Secretary may approve--
(i) a petition for an exemption for a device from a
requirement if he determines that compliance with such
requirement is not required to assure that the device
will be safe and effective and otherwise in compliance
with this Act, and
(ii) a petition for a variance for a device from a
requirement if he determines that the methods to be
used in, and the facilities and controls to be used
for, the manufacture, packing, storage, and
installation of the device in lieu of the methods,
controls, and facilities prescribed by the requirement
are sufficient to assure that the device will be safe
and effective and otherwise in compliance with this
Act.
An order of the Secretary approving a petition for a variance
shall prescribe such conditions respecting the methods used in,
and the facilities and controls used for, the manufacture,
packing, storage, and installation of the device to be granted
the variance under the petition as may be necessary to assure
that the device will be safe and effective and otherwise in
compliance with this Act.
(D) After the issuance of an order under subparagraph (B)
respecting a petition, the petitioner shall have an opportunity
for an informal hearing on such order.
(3) The Secretary shall establish an advisory committee for
the purpose of advising and making recommendations to him with
respect to regulations proposed to be promulgated under
paragraph (1)(A) and the approval or disapproval of petitions
submitted under paragraph (2). The advisory committee shall be
composed of nine members as follows:
(A) Three of the members shall be appointed from
persons who are officers or employees of any State or
local government or of the Federal Government.
(B) Two of the members shall be appointed from
persons who are representative of interests of the
device manufacturing industry; two of the members shall
be appointed from persons who are representative of the
interests of physicians and other health professionals;
and two of the members shall be representative of the
interests of the general public.
Members of the advisory committee who are not officers or
employees of the United States, while attending conferences or
meetings of the committee or otherwise engaged in its business,
shall be entitled to receive compensation at rates to be fixed
by the Secretary, which rates may not exceed the daily
equivalent of the rate in effect for grade GS-18 of the General
Schedule, for each day (including traveltime) they are so
engaged; and while so serving away from their homes or regular
places of business each member may be allowed travel expenses,
including per diem in lieu of subsistence, as authorized by
section 5703 of title 5 of the United States Code for persons
in the Government service employed intermittently. The
Secretary shall designate one of the members of the advisory
committee to serve as its chairman. The Secretary shall furnish
the advisory committee with clerical and other assistance.
Section 14 of the Federal Advisory Committee Act shall not
apply with respect to the duration of the advisory committee
established under this paragraph.
Exemption for Devices for Investigational Use
(g)(1) It is the purpose of this subsection to encourage to
the extent consistent with the protection of the public health
and safety and with ethical standards, the discovery and
development of useful devices intended for human use and to
that end to maintain optimum freedom for scientific
investigators in their pursuit of that purpose.
(2)(A) The Secretary shall, within the one hundred and
twenty-day period beginning on the date of the enactment of
this section, by regulation prescribe procedures and conditions
under which devices intended for human use may upon application
be granted an exemption from the requirements of section 502,
510, 514, 515, 516, 519, or 721 or subsection (e) or (f) of
this section or from any combination of such requirements to
permit the investigational use of such devices by experts
qualified by scientific training and experience to investigate
the safety and effectiveness of such devices.
(B) The conditions prescribed pursuant to subparagraph (A)
shall include the following:
(i) A requirement that an application be submitted to
the Secretary before an exemption may be granted and
that the application be submitted in such form and
manner as the Secretary shall specify.
(ii) A requirement that the person applying for an
exemption for a device assure the establishment and
maintenance of such records, and the making of such
reports to the Secretary of safety or effectiveness
data obtained as a result of the investigational use of
the device during the exemption, as the Secretary
determines will enable him to assure compliance with
such conditions, review the progress of the
investigation, and evaluate the safety and
effectiveness of the device.
(iii) Such other requirements as the Secretary may
determine to be necessary for the protection of the
public health and safety.
(C) Procedures and conditions prescribed pursuant to
subparagraph (A) for an exemption may appropriately vary
depending on (i) the scope and duration of clinical testing to
be conducted under such exemption, (ii) the number of human
subjects that are to be involved in such testing, (iii) the
need to permit changes to be made in the device subject to the
exemption during testing conducted in accordance with a
clinical testing plan required under paragraph (3)(A), and (iv)
whether the clinical testing of such device is for the purpose
of developing data to obtain approval for the commercial
distribution of such device.
(3) Procedures and conditions prescribed pursuant to
paragraph (2)(A) shall require, as a condition to the exemption
of any device to be the subject of testing involving human
subjects, that the person applying for the exemption--
(A) submit a plan for any proposed clinical testing
of the device and a report of prior investigations of
the device (including, where appropriate, tests on
animals) adequate to justify the proposed clinical
testing--
(i) to the institutional review committee
established in accordance with regulations of
the Secretary to supervise clinical testing of
devices in the facilities where the proposed
clinical testing is to be conducted, or
(ii) to the Secretary, if--
(I) no such committee exists, or
(II) the Secretary finds that the
process of review by such committee is
inadequate (whether or not the plan for
such testing has been approved by such
committee),
for review for adequacy to justify the commencement of
such testing; and, unless the plan and report are
submitted to the Secretary, submit to the Secretary a
summary of the plan and a report of prior
investigations of the device (including, where
appropriate, tests on animals);
(B) promptly notify the Secretary (under such
circumstances and in such manner as the Secretary
prescribes) of approval by an institutional review
committee of any clinical testing plan submitted to it
in accordance with subparagraph (A);
(C) in the case of a device to be distributed to
investigators for testing, obtain signed agreements
from each of such investigators that any testing of the
device involving human subjects will be under such
investigator's supervision and in accordance with
subparagraph (D) and submit such agreements to the
Secretary; and
(D) assure that informed consent will be obtained
from each human subject (or his representative) of
proposed clinical testing involving such device, except
where, subject to such conditions as the Secretary may
prescribe--
(i) the proposed clinical testing poses no
more than minimal risk to the human subject and
includes appropriate safeguards to protect the
rights, safety, and welfare of the human
subject; or
(ii) the investigator conducting or
supervising the proposed clinical testing of
the device determines in writing that there
exists a life threatening situation involving
the human subject of such testing which
necessitates the use of such device and it is
not feasible to obtain informed consent from
the subject and there is not sufficient time to
obtain such consent from his representative.
The determination required by subparagraph (D)(ii) shall be
concurred in by a licensed physician who is not involved in the
testing of the human subject with respect to which such
determination is made unless immediate use of the device is
required to save the life of the human subject of such testing
and there is not sufficient time to obtain such concurrence.
(4)(A) An application, submitted in accordance with the
procedures prescribed by regulations under paragraph (2), for
an exemption for a device (other than an exemption from section
516) shall be deemed approved on the thirtieth day after the
submission of the application to the Secretary unless on or
before such day the Secretary by order disapproves the
application and notifies the applicant of the disapproval of
the application.
(B) The Secretary may disapprove an application only if he
finds that the investigation with respect to which the
application is submitted does not conform to procedures and
conditions prescribed under regulations under paragraph (2).
Such a notification shall contain the order of disapproval and
a complete statement of the reasons for the Secretary's
disapproval of the application and afford the applicant
opportunity for an informal hearing on the disapproval order.
(C) Consistent with paragraph (1), the Secretary shall not
disapprove an application under this subsection because the
Secretary determines that--
(i) the investigation may not support a substantial
equivalence or de novo classification determination or
approval of the device;
(ii) the investigation may not meet a requirement,
including a data requirement, relating to the approval
or clearance of a device; or
(iii) an additional or different investigation may be
necessary to support clearance or approval of the
device.
(5) The Secretary may by order withdraw an exemption granted
under this subsection for a device if the Secretary determines
that the conditions applicable to the device under this
subsection for such exemption are not met. Such an order may be
issued only after opportunity for an informal hearing, except
that such an order may be issued before the provision of an
opportunity for an informal hearing if the Secretary determines
that the continuation of testing under the exemption with
respect to which the order is to be issued will result in an
unreasonable risk to the public health.
(6)(A) Not later than 1 year after the date of the enactment
of the Food and Drug Administration Modernization Act of 1997,
the Secretary shall by regulation establish, with respect to a
device for which an exemption under this subsection is in
effect, procedures and conditions that, without requiring an
additional approval of an application for an exemption or the
approval of a supplement to such an application, permit--
(i) developmental changes in the device (including
manufacturing changes) that do not constitute a
significant change in design or in basic principles of
operation and that are made in response to information
gathered during the course of an investigation; and
(ii) changes or modifications to clinical protocols
that do not affect--
(I) the validity of data or information
resulting from the completion of an approved
protocol, or the relationship of likely patient
risk to benefit relied upon to approve a
protocol;
(II) the scientific soundness of an
investigational plan submitted under paragraph
(3)(A); or
(III) the rights, safety, or welfare of the
human subjects involved in the investigation.
(B) Regulations under subparagraph (A) shall provide that a
change or modification described in such subparagraph may be
made if--
(i) the sponsor of the investigation determines, on
the basis of credible information (as defined by the
Secretary) that the applicable conditions under
subparagraph (A) are met; and
(ii) the sponsor submits to the Secretary, not later
than 5 days after making the change or modification, a
notice of the change or modification.
(7)(A) In the case of a person intending to investigate the
safety or effectiveness of a class III device or any
implantable device, the Secretary shall ensure that the person
has an opportunity, prior to submitting an application to the
Secretary or to an institutional review committee, to submit to
the Secretary, for review, an investigational plan (including a
clinical protocol). If the applicant submits a written request
for a meeting with the Secretary regarding such review, the
Secretary shall, not later than 30 days after receiving the
request, meet with the applicant for the purpose of reaching
agreement regarding the investigational plan (including a
clinical protocol). The written request shall include a
detailed description of the device, a detailed description of
the proposed conditions of use of the device, a proposed plan
(including a clinical protocol) for determining whether there
is a reasonable assurance of effectiveness, and, if available,
information regarding the expected performance from the device.
(B) Any agreement regarding the parameters of an
investigational plan (including a clinical protocol) that is
reached between the Secretary and a sponsor or applicant shall
be reduced to writing and made part of the administrative
record by the Secretary. Any such agreement shall not be
changed, except--
(i) with the written agreement of the sponsor or
applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (C) by the director of the office in which
the device involved is reviewed, that a substantial
scientific issue essential to determining the safety or
effectiveness of the device involved has been
identified.
(C) A decision under subparagraph (B)(ii) by the director
shall be in writing, and may be made only after the Secretary
has provided to the sponsor or applicant an opportunity for a
meeting at which the director and the sponsor or applicant are
present and at which the director documents the scientific
issue involved.
(8)(A) At any time, the Secretary may prohibit the sponsor of
an investigation from conducting the investigation (referred to
in this paragraph as a ``clinical hold'') if the Secretary
makes a determination described in subparagraph (B). The
Secretary shall specify the basis for the clinical hold,
including the specific information available to the Secretary
which served as the basis for such clinical hold, and confirm
such determination in writing.
(B) For purposes of subparagraph (A), a determination
described in this subparagraph with respect to a clinical hold
is a determination that--
(i) the device involved represents an unreasonable
risk to the safety of the persons who are the subjects
of the clinical investigation, taking into account the
qualifications of the clinical investigators,
information about the device, the design of the
clinical investigation, the condition for which the
device is to be investigated, and the health status of
the subjects involved; or
(ii) the clinical hold should be issued for such
other reasons as the Secretary may by regulation
establish.
(C) Any written request to the Secretary from the sponsor of
an investigation that a clinical hold be removed shall receive
a decision, in writing and specifying the reasons therefor,
within 30 days after receipt of such request. Any such request
shall include sufficient information to support the removal of
such clinical hold.
Release of Safety and Effectiveness Information
(h)(1) The Secretary shall promulgate regulations under which
a detailed summary of information respecting the safety and
effectiveness of a device which information was submitted to
the Secretary and which was the basis for--
(A) an order under section 515(d)(1)(A) approving an
application for premarket approval for the device or
denying approval of such an application or an order
under section 515(e) withdrawing approval of such an
application for the device,
(B) an order under section 515(f)(6)(A) revoking an
approved protocol for the device, an order under
section 515(f)(6)(B) declaring a protocol for the
device completed or not completed, or an order under
section 515(f)(7) revoking the approval of the device,
or
(C) an order approving an application under
subsection (g) for an exemption for the device from
section 516 or an order disapproving, or withdrawing
approval of, an application for an exemption under such
subsection for the device,
shall be made available to the public upon issuance of the
order. Summaries of information made available pursuant to this
paragraph respecting a device shall include information
respecting any adverse effects on health of the device.
(2) The Secretary shall promulgate regulations under which
each advisory committee established under section 515(g)(2)(B)
shall make available to the public a detailed summary of
information respecting the safety and effectiveness of a device
which information was submitted to the advisory committee and
which was the basis for its recommendation to the Secretary
made pursuant to section 515(g)(2)(A). A summary of information
upon which such a recommendation is based shall be made
available pursuant to this paragraph only after the issuance of
the order with respect to which the recommendation was made and
each summary shall include information respecting any adverse
effect on health of the device subject to such order.
(3) Except as provided in paragraph (4), any information
respecting a device which is made available pursuant to
paragraph (1) or (2) of this subsection (A) may not be used to
establish the safety or effectiveness of another device for
purposes of this Act by any person other than the person who
submitted the information so made available, and (B) shall be
made available subject to subsection (c) of this section.
(4)(A) Subject to subparagraph (C), any information contained
in an application for premarket approval filed with the
Secretary pursuant to section 515(c) (including information
from clinical and preclinical tests or studies that demonstrate
the safety and effectiveness of a device, but excluding
descriptions of methods of manufacture and product composition
and other trade secrets) shall be available, 6 years after the
application has been approved by the Secretary, for use by the
Secretary in--
(i) approving another device;
(ii) determining whether a product development
protocol has been completed, under section 515 for
another device;
(iii) establishing a performance standard or special
control under this Act; or
(iv) classifying or reclassifying another device
under section 513 and subsection (l)(2).
(B) The publicly available detailed summaries of information
respecting the safety and effectiveness of devices required by
paragraph (1)(A) shall be available for use by the Secretary as
the evidentiary basis for the agency actions described in
subparagraph (A).
(C) No information contained in an application for premarket
approval filed with the Secretary pursuant to section 515(c)
may be used to approve or clear any application submitted under
section 515 or 510(k) or to classify a product under section
513(f)(2) for a combination product containing as a constituent
part an approved drug (as defined in section 503(g)(5)(B))
unless--
(i) the application includes the certification or
statement referenced in section 503(g)(5)(A);
(ii) the applicant provides notice as described in
section 503(g)(5)(A); and
(iii) the Secretary's approval of such application is
subject to the provisions in section 503(g)(5)(C).
Proceedings of Advisory Panels and Committees
(i) Each panel under section 513 and each advisory committee
established under section 514(b)(5)(B) or 515(g) or under
subsection (f) of this section shall make and maintain a
transcript of any proceeding of the panel or committee. Each
such panel and committee shall delete from any transcript made
pursuant to this subsection information which under subsection
(c) of this section is to be considered confidential.
Traceability Requirements
(j) Except as provided in section 519(e), no regulation under
this Act may impose on a type or class of device requirements
for the traceability of such type or class of device unless
such requirements are necessary to assure the protection of the
public health.
Research and Development
(k) The Secretary may enter into contracts for research,
testing, and demonstrations respecting devices and may obtain
devices for research, testing, and demonstration purposes
without regard to sections 3648 and 3709 of the Revised
Statutes (31 U.S.C. 529, 41 U.S.C. 5).
Transitional Provisions for Devices Considered as New Drugs
(l)(1) Any device intended for human use--
(A) for which on the date of enactment of the Medical
Device Amendments of 1976 (hereinafter in this
subsection referred to as the ``enactment date'') an
approval of an application submitted under section
505(b) was in effect;
(B) for which such an application was filed on or
before the enactment date and with respect to which
application no order of approval or refusing to approve
had been issued on such date under subsection (c) or
(d) of such section;
(C) for which on the enactment date an exemption
under subsection (i) of such section was in effect;
(D) which is within a type of device described in
subparagraph (A), (B), or (C) and is substantially
equivalent to another device within that type;
(E) which the Secretary in a notice published in the
Federal Register before the enactment date has declared
to be a new drug subject to section 505; or
(F) with respect to which on the enactment date an
action is pending in a United States court under
section 302, 303, or 304 for an alleged violation of a
provision of section 301 which enforces a requirement
of section 505 or for an alleged violation of section
505(a),
is classified in class III unless the Secretary in response to
a petition submitted under paragraph (2) has classified such
device in class I or II.
(2) The Secretary may initiate the reclassification of a
device classified into class III under paragraph (1) of this
subsection or the manufacturer or importer of a device
classified under paragraph (1) may petition the Secretary (in
such form and manner as he shall prescribe) for the issuance of
an order classifying the device in class I or class II. Within
thirty days of the filing of such a petition, the Secretary
shall notify the petitioner of any deficiencies in the petition
which prevent the Secretary from making a decision on the
petition. Except as provided in paragraph (3)(D)(ii), within
one hundred and eighty days after the filing of a petition
under this paragraph, the Secretary shall, after consultation
with the appropriate panel under section 513, by order either
deny the petition or order the classification, in accordance
with the criteria prescribed by section 513(a)(1)(A) or
513(a)(1)(B), of the device in class I or class II.
(3)(A) In the case of a device which is described in
paragraph (1)(A) and which is in class III--
(i) such device shall on the enactment date be
considered a device with an approved application under
section 515, and
(ii) the requirements applicable to such device
before the enactment date under section 505 shall
continue to apply to such device until changed by the
Secretary as authorized by this Act.
(B) In the case of a device which is described in paragraph
(1)(B) and which is in class III, an application for such
device shall be considered as having been filed under section
515 on the enactment date. The period in which the Secretary
shall act on such application in accordance with section
515(d)(1) shall be one hundred and eighty days from the
enactment date (or such greater period as the Secretary and the
applicant may agree upon after the Secretary has made the
finding required by section 515(d)(1)(B)(i)) less the number of
days in the period beginning on the date an application for
such device was filed under section 505 and ending on the
enactment date. After the expiration of such period such device
is required, unless exempt under subsection (g), to have in
effect an approved application under section 515.
(C) A device which is described in paragraph (1)(C) and which
is in class III shall be considered a new drug until the
expiration of the ninety-day period beginning on the date of
the promulgation of regulations under subsection (g) of this
section. After the expiration of such period such device is
required, unless exempt under subsection (g), to have in effect
an approved application under section 515.
(D)(i) Except as provided in clauses (ii) and (iii), a device
which is described in subparagraph (D), (E), or (F) of
paragraph (1) and which is in class III is required, unless
exempt under subsection (g) of this section, to have on and
after sixty days after the enactment date in effect an approved
application under section 515.
(ii) If--
(I) a petition is filed under paragraph (2) for a
device described in subparagraph (D), (E), or (F) of
paragraph (1), or
(II) an application for premarket approval is filed
under section 515 for such a device,
within the sixty-day period beginning on the enactment date (or
within such greater period as the Secretary, after making the
finding required under section 515(d)(1)(B), and the petitioner
or applicant may agree upon), the Secretary shall act on such
petition or application in accordance with paragraph (2) or
section 515 except that the period within which the Secretary
must act on the petition or application shall be within the one
hundred and twenty-day period beginning on the date the
petition or application is filed. If such a petition or
application is filed within such sixty-day (or greater) period,
clause (i) of this subparagraph shall not apply to such device
before the expiration of such one hundred and twenty-day
period, or if such petition is denied or such application is
denied approval, before the date of such denial, whichever
occurs first.
(iii) In the case of a device which is described in
subparagraph (E) of paragraph (1), which the Secretary in a
notice published in the Federal Register after March 31, 1976,
declared to be a new drug subject to section 505, and which is
in class III--
(I) the device shall, after eighteen months after the
enactment date, have in effect an approved application
under section 515 unless exempt under subsection (g) of
this section, and
(II) the Secretary may, during the period beginning
one hundred and eighty days after the enactment date
and ending eighteen months after such date, restrict
the use of the device to investigational use by experts
qualified by scientific training and experience to
investigate the safety and effectiveness of such
device, and to investigational use in accordance with
the requirements applicable under regulations under
subsection (g) of this section to investigational use
of devices granted an exemption under such subsection.
If the requirements under subsection (g) of this section are
made applicable to the investigational use of such a device,
they shall be made applicable in such a manner that the device
shall be made reasonably available to physicians meeting
appropriate qualifications prescribed by the Secretary.
(5)(A) Before December 1, 1991, the Secretary shall by order
require manufacturers of devices described in paragraph (1),
which are subject to revision of classification under
subparagraph (B), to submit to the Secretary a summary of and
citation to any information known or otherwise available to the
manufacturers respecting the devices, including adverse safety
or effectiveness information which has not been submitted under
section 519. The Secretary may require a manufacturer to submit
the adverse safety or effectiveness data for which a summary
and citation were submitted, if such data are available to the
manufacturer.
(B) Except as provided in subparagraph (C), after the
issuance of an order under subparagraph (A) but before December
1, 1992, the Secretary shall publish a regulation in the
Federal Register for each device which is classified in class
III under paragraph (1) revising the classification of the
device so that the device is classified into class I or class
II, unless the regulation requires the device to remain in
class III. In determining whether to revise the classification
of a device or to require a device to remain in class III, the
Secretary shall apply the criteria set forth in section 513(a).
Before the publication of a regulation requiring a device to
remain in class III or revising its classification, the
Secretary shall publish a proposed regulation respecting the
classification of a device under this subparagraph and provide
an opportunity for the submission of comments on any such
regulation. No regulation under this subparagraph requiring a
device to remain in class III or revising its classification
may take effect before the expiration of 90 days from the date
of the publication in the Federal Register of the proposed
regulation.
(C) The Secretary may by notice published in the Federal
Register extend the period prescribed by subparagraph (B) for a
device for an additional period not to exceed 1 year.
Humanitarian Device Exemption
(m)(1) To the extent consistent with the protection of the
public health and safety and with ethical standards, it is the
purpose of this subsection to encourage the discovery and use
of devices intended to benefit patients in the treatment and
diagnosis of diseases or conditions that affect not more than
8,000 individuals in the United States.
(2) The Secretary may grant a request for an exemption from
the effectiveness requirements of sections 514 and 515 for a
device for which the Secretary finds that--
(A) the device is designed to treat or diagnose a
disease or condition that affects not more than 8,000
individuals in the United States,
(B) the device would not be available to a person
with a disease or condition referred to in subparagraph
(A) unless the Secretary grants such an exemption and
there is no comparable device, other than under this
exemption, available to treat or diagnose such disease
or condition, and
(C) the device will not expose patients to an
unreasonable or significant risk of illness or injury
and the probable benefit to health from the use of the
device outweighs the risk of injury or illness from its
use, taking into account the probable risks and
benefits of currently available devic or alternative
forms of treatment.
The request shall be in the form of an application submitted to
the Secretary and such application shall include the
certification required under section 402(j)(5)(B) of the Public
Health Service Act (which shall not be considered an element of
such application). Not later than 75 days after the date of the
receipt of the application, the Secretary shall issue an order
approving or denying the application.
(3) Except as provided in paragraph (6), no person granted an
exemption under paragraph (2) with respect to a device may sell
the device for an amount that exceeds the costs of research and
development, fabrication, and distribution of the device.
(4) Devices granted an exemption under paragraph (2) may only
be used--
(A) in facilities in which clinical testing of
devices is supervised by an institutional review
committee established in accordance with the
regulations of the Secretary; and
(B) if, before the use of a device, an institutional
review committee approves the use in the treatment or
diagnosis of a disease or condition referred to in
paragraph (2)(A), unless a physician determines in an
emergency situation that approval from an institutional
review committee can not be obtained in time to prevent
serious harm or death to a patient.
In a case described in subparagraph (B) in which a physician
uses a device without an approval from an institutional review
committee, the physician shall, after the use of the device,
notify the chairperson of the institutional review committee of
such use. Such notification shall include the identification of
the patient involved, the date on which the device was used,
and the reason for the use.
(5) The Secretary may require a person granted an exemption
under paragraph (2) to demonstrate continued compliance with
the requirements of this subsection if the Secretary believes
such demonstration to be necessary to protect the public
health, if the Secretary has reason to believe that the
requirements of paragraph (6) are no longer met, or if the
Secretary has reason to believe that the criteria for the
exemption are no longer met. If the person granted an exemption
under paragraph (2) fails to demonstrate continued compliance
with the requirements of this subsection, the Secretary may
suspend or withdraw the exemption from the effectiveness
requirements of sections 514 and 515 for a humanitarian device
only after providing notice and an opportunity for an informal
hearing.
(6)(A) Except as provided in subparagraph (D), the
prohibition in paragraph (3) shall not apply with respect to a
person granted an exemption under paragraph (2) if each of the
following conditions apply:
(i) The device with respect to which the exemption is
granted--
(I) is intended for the treatment or
diagnosis of a disease or condition that occurs
in pediatric patients or in a pediatric
subpopulation, and such device is labeled for
use in pediatric patients or in a pediatric
subpopulation in which the disease or condition
occurs; or
(II) is intended for the treatment or
diagnosis of a disease or condition that does
not occur in pediatric patients or that occurs
in pediatric patients in such numbers that the
development of the device for such patients is
impossible, highly impracticable, or unsafe.
(ii) During any calendar year, the number of such
devices distributed during that year under each
exemption granted under this subsection does not exceed
the annual distribution number for such device. In this
paragraph, the term ``annual distribution number''
means the number of such devices reasonably needed to
treat, diagnose, or cure a population of 8,000
individuals in the United States. The Secretary shall
determine the annual distribution number when the
Secretary grants such exemption.
(iii) Such person immediately notifies the Secretary
if the number of such devices distributed during any
calendar year exceeds the annual distribution number
referred to in clause (ii).
(iv) The request for such exemption is submitted on
or before October 1, [2017] 2022.
(B) The Secretary may inspect the records relating to the
number of devices distributed during any calendar year of a
person granted an exemption under paragraph (2) for which the
prohibition in paragraph (3) does not apply.
(C) A person may petition the Secretary to modify the annual
distribution number determined by the Secretary under
subparagraph (A)(ii) with respect to a device if additional
information arises, and the Secretary may modify such annual
distribution number.
(D) If a person notifies the Secretary, or the Secretary
determines through an inspection under subparagraph (B), that
the number of devices distributed during any calendar year
exceeds the annual distribution number, as required under
subparagraph (A)(iii), and modified under subparagraph (C), if
applicable, then the prohibition in paragraph (3) shall apply
with respect to such person for such device for any sales of
such device after such notification.
(E)(i) In this subsection, the term ``pediatric patients''
means patients who are 21 years of age or younger at the time
of the diagnosis or treatment.
(ii) In this subsection, the term ``pediatric subpopulation''
means 1 of the following populations:
(I) Neonates.
(II) Infants.
(III) Children.
(IV) Adolescents.
(7) The Secretary shall refer any report of an adverse event
regarding a device described in paragraph (6)(A)(i)(I) for
which the prohibition under paragraph (3) does not apply
pursuant to paragraph (6)(A) that the Secretary receives to the
Office of Pediatric Therapeutics, established under section 6
of the Best Pharmaceuticals for Children Act (Public Law 107-
109). In considering the report, the Director of the Office of
Pediatric Therapeutics, in consultation with experts in the
Center for Devices and Radiological Health, shall provide for
periodic review of the report by the Pediatric Advisory
Committee, including obtaining any recommendations of such
committee regarding whether the Secretary should take action
under this Act in response to the report.
(8) The Secretary, acting through the Office of Pediatric
Therapeutics and the Center for Devices and Radiological
Health, shall provide for an annual review by the Pediatric
Advisory Committee of all devices described in paragraph
(6)(A)(i)(I) to ensure that the exemption under paragraph (2)
remains appropriate for the pediatric populations for which it
is granted.
Regulation of Contact Lens as Devices
(n)(1) All contact lenses shall be deemed to be devices under
section 201(h).
(2) Paragraph (1) shall not be construed as bearing on or
being relevant to the question of whether any product other
than a contact lens is a device as defined by section 201(h) or
a drug as defined by section 201(g).
(o) Regulation of Medical and Certain Decisions Support
Software.--
(1) The term device, as defined in section 201(h),
shall not include a software function that is
intended--
(A) for administrative support of a health
care facility, including the processing and
maintenance of financial records, claims or
billing information, appointment schedules,
business analytics, information about patient
populations, admissions, practice and inventory
management, analysis of historical claims data
to predict future utilization or cost-
effectiveness, determination of health benefit
eligibility, population health management, and
laboratory workflow;
(B) for maintaining or encouraging a healthy
lifestyle and is unrelated to the diagnosis,
cure, mitigation, prevention, or treatment of a
disease or condition;
(C) to serve as electronic patient records,
including patient-provided information, to the
extent that such records are intended to
transfer, store, convert formats, or display
the equivalent of a paper medical chart, so
long as--
(i) such records were created,
stored, transferred, or reviewed by
health care professionals, or by
individuals working under supervision
of such professionals;
(ii) such records are part of health
information technology that is
certified under section 3001(c)(5) of
the Public Health Service Act; and
(iii) such function is not intended
to interpret or analyze patient
records, including medical image data,
for the purpose of the diagnosis, cure,
mitigation, prevention, or treatment of
a disease or condition;
(D) for transferring, storing, converting
formats, or displaying clinical laboratory test
or other device data and results, findings by a
health care professional with respect to such
data and results, general information about
such findings, and general background
information about such laboratory test or other
device, unless such function is intended to
interpret or analyze clinical laboratory test
or other device data, results, and findings; or
(E) unless the function is intended to
acquire, process, or analyze a medical image or
a signal from an in vitro diagnostic device or
a pattern or signal from a signal acquisition
system, for the purpose of--
(i) displaying, analyzing, or
printing medical information about a
patient or other medical information
(such as peer-reviewed clinical studies
and clinical practice guidelines);
(ii) supporting or providing
recommendations to a health care
professional about prevention,
diagnosis, or treatment of a disease or
condition; and
(iii) enabling such health care
professional to independently review
the basis for such recommendations that
such software presents so that it is
not the intent that such health care
professional rely primarily on any of
such recommendations to make a clinical
diagnosis or treatment decision
regarding an individual patient.
(2) In the case of a product with multiple functions
that contains--
(A) at least one software function that meets
the criteria under paragraph (1) or that
otherwise does not meet the definition of
device under section 201(h); and
(B) at least one function that does not meet
the criteria under paragraph (1) and that
otherwise meets the definition of a device
under section 201(h),
the Secretary shall not regulate the software function
of such product described in subparagraph (A) as a
device. Notwithstanding the preceding sentence, when
assessing the safety and effectiveness of the device
function or functions of such product described in
subparagraph (B), the Secretary may assess the impact
that the software function or functions described in
subparagraph (A) have on such device function or
functions.
(3)(A) Notwithstanding paragraph (1), a software
function described in subparagraph (C), (D), or (E) of
paragraph (1) shall not be excluded from the definition
of device under section 201(h) if--
(i) the Secretary makes a finding that use of
such software function would be reasonably
likely to have serious adverse health
consequences; and
(ii) the software function has been
identified in a final order issued by the
Secretary under subparagraph (B).
(B) Subparagraph (A) shall apply only if the
Secretary--
(i) publishes a notification and proposed
order in the Federal Register;
(ii) includes in such notification the
Secretary's finding, including the rationale
and identification of the evidence on which
such finding was based, as described in
subparagraph (A)(i); and
(iii) provides for a period of not less than
30 calendar days for public comment before
issuing a final order or withdrawing such
proposed order.
(C) In making a finding under subparagraph (A)(i)
with respect to a software function, the Secretary
shall consider--
(i) the likelihood and severity of patient
harm if the software function were to not
perform as intended;
(ii) the extent to which the software
function is intended to support the clinical
judgment of a health care professional;
(iii) whether there is a reasonable
opportunity for a health care professional to
review the basis of the information or
treatment recommendation provided by the
software function; and
(iv) the intended user and user environment,
such as whether a health care professional will
use a software function of a type described in
subparagraph (E) of paragraph (1).
(4) Nothing in this subsection shall be construed as
limiting the authority of the Secretary to--
(A) exercise enforcement discretion as to any
device subject to regulation under this Act;
(B) regulate software used in the manufacture
and transfusion of blood and blood components
to assist in the prevention of disease in
humans; or
(C) regulate software as a device under this
Act if such software meets the criteria under
section 513(a)(1)(C).
(p) Regulation of Over-the-Counter Hearing Aids.--
(1) Definition.--
(A) In this subsection, the term ``over-the-
counter hearing aid'' means a device--
(i) that uses the same fundamental
scientific technology as air conduction
hearing aids (as defined in section
874.3300 of title 21, Code of Federal
Regulations) (or any successor
regulation) or wireless air conduction
hearing aids (as defined in section
874.3305 of title 21, Code of Federal
Regulations) (or any successor
regulation);
(ii) that is intended to be used by
adults over the age of 18 to compensate
for perceived mild to moderate hearing
impairment;
(iii) that, through tools, tests, or
software, allows the user to control
the over-the-counter hearing aid and
customize it to the user's hearing
needs;
(iv) that may--
(I) use wireless technology;
or
(II) include tests for self-
assessment of hearing loss; and
(v) that is available over-the-
counter, without the supervision,
prescription, or other order,
involvement, or intervention of a
licensed person, to consumers through
in-person transactions, by mail, or
online.
(B) Such term does not include a personal
sound amplification product intended to amplify
sound for nonhearing impaired consumers in
situations including hunting and bird-watching.
(2) Regulation.--An over-the-counter hearing aid
shall be subject to the regulations promulgated in
accordance with section 613(b) of the FDA
Reauthorization Act of 2017 and shall be exempt from
sections 801.420 and 801.421 of title 21, Code of
Federal Regulations (or any successor regulations).
(q) Diagnostic Imaging Devices Intended for Use With Contrast
Agents.--
(1) The Secretary may, subject to the succeeding
provisions of this subsection, approve an application
(or a supplement to such an application) submitted
under section 515 with respect to an applicable medical
imaging device, or, in the case of an applicable
medical imaging device for which a notification is
submitted under section 510(k), may make a substantial
equivalence determination with respect to an applicable
medical imaging device, or may grant a request
submitted under section 513(f)(2) for an applicable
medical imaging device, if the indications and
conditions of use proposed in such application,
notification, or request involve the use of a contrast
agent that is not--
(A) in a concentration, rate of
administration, or route of administration that
is different from those described in the
approved labeling of the contrast agent, except
that the Secretary may approve such
application, make such substantial equivalence
determination, or grant such request if the
Secretary determines that such differences in
concentration, rate of administration, or route
of administration exist but do not adversely
affect the safety and effectiveness of the
contrast agent when used with the device;
(B) in a region, organ, or system of the body
that is different from those described in the
approved labeling of the contrast agent, except
that the Secretary may approve such
application, make such substantial equivalence
determination, or grant such request if the
Secretary determines that such differences in
region, organ, or system of the body exist but
do not adversely affect the safety and
effectiveness of the contrast agent when used
with the device;
(C) in a patient population that is different
from those described in the approved labeling
of the contrast agent, except that the
Secretary may approve such application, make
such substantial equivalence determination, or
grant such request if the Secretary determines
such differences in patient population exist
but do not adversely affect the safety and
effectiveness of the contrast agent when used
with the device; or
(D) in an imaging modality (such as an
ultrasound, an x-ray, diagnostic
radiopharmaceutical-based technologies,
fluorescent imaging technology, or magnetic
resonance) that is different from those
described in the approved labeling of the
contrast agent.
(2) The agency center charged with premarket review
of devices shall have primary jurisdiction with respect
to the review of an application, notification, or
request described in paragraph (1). In conducting such
review, such agency center may--
(A) consult with the agency center charged
with the premarket review of drugs or
biological products; and
(B) review information and data provided to
the Secretary by the sponsor of a contrast
agent in an application submitted under section
505 of this Act or section 351 of the Public
Health Service Act, so long as the sponsor of
such contrast agent has provided to the sponsor
of the applicable medical imaging device that
is the subject of such review a right of
reference and the application is submitted in
accordance with this subsection.
(3) An application submitted under section 515, a
notification submitted under section 510(k), or a
request submitted under section 513(f)(2), as described
in paragraph (1), with respect to an applicable medical
imaging device shall be subject to the requirements of
such respective section. Such application,
notification, or request shall only be subject to the
requirements of this Act applicable to devices.
(4) For purposes of this subsection and section
505(y)--
(A) the term ``applicable medical imaging
device'' means a device intended to be used in
conjunction with a contrast agent (or class of
contrast agents) for an imaging use that is not
described in the approved labeling of such
contrast agent (or the approved labeling of any
contrast agent in the same class as such
contrast agent); and
(B) the term ``contrast agent'' means a drug
that is approved under section 505 or licensed
under section 351 of the Public Health Service
Act, is intended for use in conjunction with an
applicable medical imaging device, and--
(i) is a diagnostic
radiopharmaceutical, as defined in
section 315.2 and 601.31 of title 21,
Code of Federal Regulations (or any
successor regulations); or
(ii) is a diagnostic agent that
improves the visualization of structure
or function within the body by
increasing the relative difference in
signal intensity within the target
tissue, structure, or fluid.
* * * * * * *
SEC. 523. ACCREDITED PERSONS.
(a) In General.--
(1) Review and classification of devices.--Not later
than 1 year after the date of the enactment of the Food
and Drug Administration Modernization Act of 1997, the
Secretary shall, subject to paragraph (3), accredit
persons for the purpose of reviewing reports submitted
under section 510(k) and making recommendations to the
Secretary regarding the initial classification of
devices under section 513(f)(1).
(2) Requirements regarding review.--
(A) In general.--In making a recommendation
to the Secretary under paragraph (1), an
accredited person shall notify the Secretary in
writing of the reasons for the recommendation.
(B) Time period for review.--Not later than
30 days after the date on which the Secretary
is notified under subparagraph (A) by an
accredited person with respect to a
recommendation of an initial classification of
a device, the Secretary shall make a
determination with respect to the initial
classification.
(C) Special rule.--The Secretary may change
the initial classification under section
513(f)(1) that is recommended under paragraph
(1) by an accredited person, and in such case
shall provide to such person, and the person
who submitted the report under section 510(k)
for the device, a statement explaining in
detail the reasons for the change.
(3) Certain devices.--
(A) In general.--An accredited person may not
be used to perform a review of--
(i) a class III device;
[(ii) a class II device which is
intended to be permanently implantable
or life sustaining or life supporting;
or
[(iii) a class II device which
requires clinical data in the report
submitted under section 510(k) for the
device, except that the number of class
II devices to which the Secretary
applies this clause for a year, less
the number of such reports to which
clauses (i) and (ii) apply, may not
exceed 6 percent of the number that is
equal to the total number of reports
submitted to the Secretary under such
section for such year less the number
of such reports to which such clauses
apply for such year.]
(ii) a device classified under
section 513(f)(2) or designated under
section 515C(d); or
(iii) a device that is of a type, or
subset of a type, listed as not
eligible for review under subparagraph
(B)(iii).
[(B) Adjustment.--In determining for a year
the ratio described in subparagraph (A)(iii),
the Secretary shall not include in the
numerator class III devices that the Secretary
reclassified into class II, and the Secretary
shall include in the denominator class II
devices for which reports under section 510(k)
were not required to be submitted by reason of
the operation of section 510(m).]
(B) Designation for review.--The Secretary
shall--
(i) issue draft guidance on the
factors the Secretary will use in
determining whether a class I or class
II device type, or subset of such
device types, is eligible for review by
an accredited person, including--
(I) the risk of the device
type, or subset of such device
type; and
(II) whether the device type,
or subset of such device type,
is permanently implantable,
life sustaining, or life
supporting;
(ii) not later than 24 months after
the date on which the Secretary issues
such draft guidance, finalize such
guidance; and
(iii) beginning on the date such
guidance is finalized, designate and
post on the internet website of the
Food and Drug Administration, an
updated list of class I and class II
device types, or subsets of such device
types, and the Secretary's
determination with respect to whether
each such device type, or subset of a
device type, is eligible or not
eligible for review by an accredited
person under this section based on the
factors described in clause (i).
(C) Interim rule.--Until the date on which
the updated list is designated and posted in
accordance with subparagraph (B)(iii), the list
in effect on the date of enactment the Medical
Device User Fee Amendments of 2017 shall be in
effect.
(b) Accreditation.--
(1) Programs.--The Secretary shall provide for such
accreditation through programs administered by the Food
and Drug Administration, other government agencies, or
by other qualified nongovernment organizations.
(2) Accreditation.--
(A) In general.--Not later than 180 days
after the date of the enactment of the Food and
Drug Administration Modernization Act of 1997,
the Secretary shall establish and publish in
the Federal Register criteria to accredit or
deny accreditation to persons who request to
perform the duties specified in subsection (a).
The Secretary shall respond to a request for
accreditation within 60 days of the receipt of
the request. The accreditation of such person
shall specify the particular activities under
subsection (a) for which such person is
accredited.
(B) Withdrawal of accreditation.--The
Secretary may suspend or withdraw accreditation
of any person accredited under this paragraph,
after providing notice and an opportunity for
an informal hearing, when such person is
substantially not in compliance with the
requirements of this section or poses a threat
to public health or fails to act in a manner
that is consistent with the purposes of this
section.
(C) Performance auditing.--To ensure that
persons accredited under this section will
continue to meet the standards of
accreditation, the Secretary shall--
(i) make onsite visits on a periodic
basis to each accredited person to
audit the performance of such person;
and
(ii) take such additional measures as
the Secretary determines to be
appropriate.
[(D) Annual report.--The Secretary shall
include in the annual report required under
section 1003(g) the names of all accredited
persons and the particular activities under
subsection (a) for which each such person is
accredited and the name of each accredited
person whose accreditation has been withdrawn
during the year.]
[(E)] (D) Periodic reaccreditation.--
(i) Period.--Subject to suspension or
withdrawal under subparagraph (B), any
accreditation under this section shall
be valid for a period of 3 years after
its issuance.
(ii) Response to reaccreditation
request.--Upon the submission of a
request by an accredited person for
reaccreditation under this section, the
Secretary shall approve or deny such
request not later than 60 days after
receipt of the request.
(iii) Criteria.--Not later than 120
days after the date of the enactment of
this subparagraph, the Secretary shall
establish and publish in the Federal
Register criteria to reaccredit or deny
reaccreditation to persons under this
section. The reaccreditation of persons
under this section shall specify the
particular activities under subsection
(a), and the devices, for which such
persons are reaccredited.
(3) Qualifications.--An accredited person shall, at a
minimum, meet the following requirements:
(A) Such person may not be an employee of the
Federal Government.
(B) Such person shall be an independent
organization which is not owned or controlled
by a manufacturer, supplier, or vendor of
devices and which has no organizational,
material, or financial affiliation with such a
manufacturer, supplier, or vendor.
(C) Such person shall be a legally
constituted entity permitted to conduct the
activities for which it seeks accreditation.
(D) Such person shall not engage in the
design, manufacture, promotion, or sale of
devices.
(E) The operations of such person shall be in
accordance with generally accepted professional
and ethical business practices.
[(E)] (F) [The operations of such person
shall be in accordance with generally accepted
professional and ethical business practices and
shall agree in writing that as a minimum it
will--] Such person shall agree, at a minimum,
to include in its request for accreditation a
commitment to, at the time of accreditation,
and at any time it is performing any review
pursuant to this section--
(i) certify that reported information
accurately reflects data reviewed;
(ii) limit work to that for which
competence and capacity are available;
(iii) treat information received,
records, reports, and recommendations
as proprietary information;
(iv) promptly respond and attempt to
resolve complaints regarding its
activities for which it is accredited;
and
(v) protect against the use, in
carrying out subsection (a) with
respect to a device, of any officer or
employee of the person who has a
financial conflict of interest
regarding the device, and annually make
available to the public disclosures of
the extent to which the person, and the
officers and employees of the person,
have maintained compliance with
requirements under this clause relating
to financial conflicts of interest.
(4) Selection of accredited persons.--The Secretary
shall provide each person who chooses to use an
accredited person to receive a section 510(k) report a
panel of at least two or more accredited persons from
which the regulated person may select one for a
specific regulatory function.
(5) Compensation of accredited persons.--Compensation
for an accredited person shall be determined by
agreement between the accredited person and the person
who engages the services of the accredited person, and
shall be paid by the person who engages such services.
(c) Duration.--The authority provided by this section
terminates October 1, [2017] 2022.
SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL
DISEASES.
(a) Definitions.--In this section:
(1) Priority review.--The term ``priority review'',
with respect to a human drug application as defined in
section 735(1), means review and action by the
Secretary on such application not later than 6 months
after receipt by the Secretary of such application, as
described in the Manual of Policies and Procedures of
the Food and Drug Administration and goals identified
in the letters described in section 101(c) of the Food
and Drug Administration Amendments Act of 2007.
(2) Priority review voucher.--The term ``priority
review voucher'' means a voucher issued by the
Secretary to the sponsor of a tropical 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 of the
Public Health Service Act after the date of approval of
the tropical disease product application.
(3) Tropical disease.--The term ``tropical disease''
means any of the following:
(A) Tuberculosis.
(B) Malaria.
(C) Blinding trachoma.
(D) Buruli Ulcer.
(E) Cholera.
(F) Dengue/dengue haemorrhagic fever.
(G) Dracunculiasis (guinea-worm disease).
(H) Fascioliasis.
(I) Human African trypanosomiasis.
(J) Leishmaniasis.
(K) Leprosy.
(L) Lymphatic filariasis.
(M) Onchocerciasis.
(N) Schistosomiasis.
(O) Soil transmitted helmithiasis.
(P) Yaws.
(Q) Filovirus Diseases.
(R) Zika Virus Disease.
(S) Any other infectious disease for which
there is no significant market in developed
nations and that disproportionately affects
poor and marginalized populations, designated
by order of the Secretary.
(4) Tropical disease product application.--The term
``tropical disease product application'' means an
application that--
(A) is a human drug application as defined in
section 735(1)--
(i) for prevention or treatment of a
tropical disease; [and]
(ii) the Secretary deems eligible for
priority review;
(iii) that contains reports of one or
more new clinical investigations (other
than bioavailability studies) that are
essential to the approval of the
application and conducted or sponsored
by the sponsor of such application; and
(iv) that contains an attestation
from the sponsor of the application
that such reports were not submitted as
part of an application for marketing
approval or licensure by a regulatory
authority in India, Brazil, Thailand,
or any country that is a member of the
Pharmaceutical Inspection Convention or
the Pharmaceutical Inspection
Cooperation Scheme prior to September
27, 2007.
(B) is approved after the date of the
enactment of the Food and Drug Administration
Amendments Act of 2007, by the Secretary for
use in the prevention, detection, or treatment
of a tropical disease; and
(C) is for a human drug, no active ingredient
(including any ester or salt of the active
ingredient) of which has been approved in any
other application under section 505(b)(1) or
section 351 of the Public Health Service Act.
(b) Priority Review Voucher.--
(1) In general.--The Secretary shall award a priority
review voucher to the sponsor of a tropical disease
product application upon approval by the Secretary of
such tropical disease product application.
(2) Transferability.--The sponsor of a tropical
disease product that receives a priority review voucher
under this section may transfer (including by sale) the
entitlement to such voucher to a sponsor of a human
drug for which an application under section 505(b)(1)
or section 351 of the Public Health Service Act will be
submitted after the date of the approval of the
tropical disease product application. There is no limit
on the number of times a priority review voucher may be
transferred before such voucher is used.
(3) Limitation.--
(A) No award for prior approved
application.--A sponsor of a tropical disease
product may not receive a priority review
voucher under this section if the tropical
disease product application was submitted to
the Secretary prior to the date of the
enactment of this section.
(B) One-year waiting period.--The Secretary
shall issue a priority review voucher to the
sponsor of a tropical disease product no
earlier than the date that is 1 year after the
date of the enactment of the Food and Drug
Administration Amendments Act of 2007.
(4) Notification.--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.
(c) Priority Review User Fee.--
(1) In general.--The Secretary shall establish a user
fee program under which a sponsor of a human drug
application that is the subject of a priority review
voucher shall pay to the Secretary a fee determined
under paragraph (2). Such fee shall be in addition to
any fee required to be submitted by the sponsor under
chapter VII.
(2) Fee amount.--The amount of the priority review
user fee shall be determined each fiscal year by the
Secretary and based on the average cost incurred by the
agency in the review of a human drug application
subject to priority review in the previous fiscal year.
(3) Annual fee setting.--The Secretary shall
establish, before the beginning of each fiscal year
beginning after September 30, 2007, for that fiscal
year, the amount of the priority review user fee.
(4) Payment.--
(A) In general.--The priority review user fee
required by this subsection shall be due upon
the submission of a human drug application
under section 505(b)(1) or section 351 of the
Public Health Service Act for which the
priority review voucher is used.
(B) Complete application.--An application
described under subparagraph (A) for which the
sponsor requests the use of a priority review
voucher shall be considered incomplete if the
fee required by this subsection and all other
applicable user fees are not paid in accordance
with the Secretary's procedures for paying such
fees.
(C) No waivers, exemptions, reductions, or
refunds.--The Secretary may not grant a waiver,
exemption, reduction, or refund of any fees due
and payable under this section.
(5) Offsetting collections.--Fees collected pursuant
to this subsection for any fiscal year--
(A) shall be deposited and credited as
offsetting collections to the account providing
appropriations to the Food and Drug
Administration; and
(B) shall not be collected for any fiscal
year except to the extent provided in advance
in appropriation Acts.
* * * * * * *
Subchapter E--General Provisions Relating to Drugs and Devices
* * * * * * *
SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
(a) Establishment.--The Secretary, acting through the
Commissioner of Food and Drugs, may enter into collaborative
agreements, to be known as Critical Path Public-Private
Partnerships, with one or more eligible entities to implement
the Critical Path Initiative of the Food and Drug
Administration by developing innovative, collaborative projects
in research, education, and outreach for the purpose of
fostering medical product innovation, enabling the acceleration
of medical product development, manufacturing, and
translational therapeutics, and enhancing medical product
safety.
(b) Eligible Entity.--In this section, the term ``eligible
entity'' means an entity that meets each of the following:
(1) The entity is--
(A) an institution of higher education (as
such term is defined in section 101 of the
Higher Education Act of 1965) or a consortium
of such institutions; or
(B) an organization described in section
501(c)(3) of the Internal Revenue Code of 1986
and exempt from tax under section 501(a) of
such Code.
(2) The entity has experienced personnel and clinical
and other technical expertise in the biomedical
sciences, which may include graduate training programs
in areas relevant to priorities of the Critical Path
Initiative.
(3) The entity demonstrates to the Secretary's
satisfaction that the entity is capable of--
(A) developing and critically evaluating
tools, methods, and processes--
(i) to increase efficiency,
predictability, and productivity of
medical product development; and
(ii) to more accurately identify the
benefits and risks of new and existing
medical products;
(B) establishing partnerships, consortia, and
collaborations with health care practitioners
and other providers of health care goods or
services; pharmacists; pharmacy benefit
managers and purchasers; health maintenance
organizations and other managed health care
organizations; health care insurers; government
agencies; patients and consumers; manufacturers
of prescription drugs, biological products,
diagnostic technologies, and devices; and
academic scientists; and
(C) securing funding for the projects of a
Critical Path Public-Private Partnership from
Federal and nonfederal governmental sources,
foundations, and private individuals.
(c) Funding.--The Secretary may not enter into a
collaborative agreement under subsection (a) unless the
eligible entity involved provides an assurance that the entity
will not accept funding for a Critical Path Public-Private
Partnership project from any organization that manufactures or
distributes products regulated by the Food and Drug
Administration unless the entity provides assurances in its
agreement with the Food and Drug Administration that the
results of the Critical Path Public-Private Partnership project
will not be influenced by any source of funding.
(d) Annual Report.--Not later than 18 months after the date
of the enactment of this section, and annually thereafter, the
Secretary, in collaboration with the parties to each Critical
Path Public-Private Partnership, shall submit a report to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives--
(1) reviewing the operations and activities of the
Partnerships in the previous year; and
(2) addressing such other issues relating to this
section as the Secretary determines to be appropriate.
(e) Definition.--In this section, the term ``medical
product'' includes a drug, a biological product as defined in
section 351 of the Public Health Service Act, a device, and any
combination of such products.
(f) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $6,000,000 for
each of fiscal years [2013 through 2017] 2018 through 2022.
* * * * * * *
CHAPTER VII--GENERAL AUTHORITY
Subchapter A--General Administrative Provisions
* * * * * * *
factory inspection
Sec. 704. (a)(1) For purposes of enforcement of this Act,
officers or employees duly designated by the Secretary, upon
presenting appropriate credentials and a written notice to the
owner, operator, or agent in charge, are authorized (A) to
enter, at reasonable times, any factory, warehouse, or
establishment in which food, drugs, devices, tobacco products,
or cosmetics are manufactured, processed, packed, or held, for
introduction into interstate commerce or after such
introduction, or to enter any vehicle, being used to transport
or hold such food, drugs, devices, tobacco products, or
cosmetics in interstate commerce; and (B) to inspect, at
reasonable times and within reasonable limits and in a
reasonable manner, such factory, warehouse, establishment, or
vehicle and all pertinent equipment, finished and unfinished
materials, containers, and labeling therein. In the case of any
person (excluding farms and restaurants) who manufactures,
processes, packs, transports, distributes, holds, or imports
foods, the inspection shall extend to all records and other
information described in section 414, when the standard for
records inspection under paragraph (1) or (2) of section 414(a)
applies, subject to the limitations established in section
414(d). In the case of any factory, warehouse, establishment,
or consulting laboratory in which prescription drugs,
nonprescription drugs intended for human use, restricted
devices, or tobacco products are manufactured, processed,
packed, or held, inspection shall extend to all things therein
(including records, files, papers, processes, controls, and
facilities) bearing on whether prescription drugs,
nonprescription drugs intended for human use, restricted
devices, or tobacco products which are adulterated or
misbranded within the meaning of this Act, or which may not be
manufactured, introduced into interstate commerce, or sold, or
offered for sale by reason of any provision of this Act, have
been or are being manufactured, processed, packed, transported,
or held in any such place, or otherwise bearing on violation of
this Act. No inspection authorized by the preceding sentence or
by paragraph (3) shall extend to financial data, sales data
other than shipment data, pricing data, personnel data (other
than data as to qualifications of technical and professional
personnel performing functions subject to this Act), and
research data (other than data relating to new drugs,
antibiotic drugs, devices, and tobacco products and subject to
reporting and inspection under regulations lawfully issued
pursuant to section 505 (i) or (k), section 519, section
520(g), or chapter IX and data relating to other drugs,
devices, or tobacco products which in the case of a new drug
would be subject to reporting or inspection under lawful
regulations issued pursuant to section 505(j)). A separate
notice shall be given for each such inspection, but a notice
shall not be required for each entry made during the period
covered by the inspection. Each such inspection shall be
commenced and completed with reasonable promptness.
(2) The provisions of the third sentence of paragraph (1)
shall not apply to--
(A) pharmacies which maintain establishments in
conformance with any applicable local laws regulating
the practice of pharmacy and medicine and which are
regularly engaged in dispensing prescription drugs or
devices, upon prescriptions of practitioners licensed
to administer such drugs or devices to patients under
the care of such practitioners in the course of their
professional practice, and which do not, either through
a subsidiary or otherwise, manufacture, prepare,
propagate, compound, or process drugs or devices for
sale other than in the regular course of their business
of dispensing or selling drugs or devices at retail;
(B) practitioners licensed by law to prescribe or
administer drugs, or prescribe or use devices, as the
case may be, and who manufacture, prepare, propagate,
compound, or process drugs, or manufacture or process
devices solely for use in the course of their
professional practice;
(C) persons who manufacture, prepare, propagate,
compound, or process drugs, or manufacture or process
devices solely for use in research, teaching, or
chemical analysis and not for sale;
(D) such other classes of persons as the Secretary
may by regulation exempt from the application of this
section upon a finding that inspection as applied to
such classes of persons in accordance with this section
is not necessary for the protection of the public
health.
(3) An officer or employee making an inspection under
paragraph (1) for purposes of enforcing the requirements of
section 412 applicable to infant formulas shall be permitted,
at all reasonable times, to have access to and to copy and
verify any records--
(A) bearing on whether the infant formula
manufactured or held in the facility inspected meets
the requirements of section 412, or
(B) required to be maintained under section 412.
(4)(A) Any records or other information that the Secretary
may inspect under this section from a person that owns or
operates an establishment that is engaged in the manufacture,
preparation, propagation, compounding, or processing of a drug
shall, upon the request of the Secretary, be provided to the
Secretary by such person, in advance of or in lieu of an
inspection, within a reasonable timeframe, within reasonable
limits, and in a reasonable manner, and in either electronic or
physical form, at the expense of such person. The Secretary's
request shall include a sufficient description of the records
requested.
(B) Upon receipt of the records requested under subparagraph
(A), the Secretary shall provide to the person confirmation of
receipt.
(C) Nothing in this paragraph supplants the authority of the
Secretary to conduct inspections otherwise permitted under this
Act in order to ensure compliance with this Act.
(b) Upon completion of any such inspection of a factory,
warehouse, consulting laboratory, or other establishment, and
prior to leaving the premises, the officer or employee making
the inspection shall give to the owner, operator, or agent in
charge a report in writing setting forth any conditions or
practices observed by him which, in his judgment, indicate that
any food, drug, device, tobacco product, or cosmetic in such
establishment (1) consists in whole or in part of any filthy,
putrid, or decomposed substance, or (2) has been prepared,
packed, or held under insanitary conditions whereby it may have
become contaminated with filth, or whereby it may have been
rendered injurious to health. A copy of such report shall be
sent promptly to the Secretary.
(c) If the officer or employee making any such inspection of
a factory, warehouse, or other establishment has obtained any
sample in the course of the inspection, upon completion of the
inspection and prior to leaving the premises he shall give to
the owner, operator, or agent in charge a receipt describing
the samples obtained.
(d) Whenever in the course of any such inspection of a
factory or other establishment where food is manufactured,
processed, or packed, the officer or employee making the
inspection obtains a sample of any such food, and an analysis
is made of such sample for the purpose of ascertaining whether
such food consists in whole or in part of any filthy, putrid,
or decomposed substance, or is otherwise unfit for food, a copy
of the results of such analysis shall be furnished promptly to
the owner, operator, or agent in charge.
(e) Every person required under section 519 or 520(g) to
maintain records and every person who is in charge or custody
of such records shall, upon request of an officer or employee
designated by the Secretary, permit such officer or employee at
all reasonable times to have access to, and to copy and verify,
such records.
(f)(1) An accredited person described in paragraph (3) shall
maintain records documenting the training qualifications of the
person and the employees of the person, the procedures used by
the person for handling confidential information, the
compensation arrangements made by the person, and the
procedures used by the person to identify and avoid conflicts
of interest. Upon the request of an officer or employee
designated by the Secretary, the person shall permit the
officer or employee, at all reasonable times, to have access
to, to copy, and to verify, the records.
(2) Within 15 days after the receipt of a written request
from the Secretary to an accredited person described in
paragraph (3) for copies of records described in paragraph (1),
the person shall produce the copies of the records at the place
designated by the Secretary.
(3) For purposes of paragraphs (1) and (2), an accredited
person described in this paragraph is a person who--
(A) is accredited under subsection (g); or
(B) is accredited under section 523.
(g)(1) The Secretary shall, subject to the provisions of this
subsection, accredit persons for the purpose of conducting
inspections of establishments that manufacture, prepare,
propagate, compound, or process class II or class III devices,
which inspections are required under section 510(h) or are
inspections of such establishments required to register under
section 510(i). The owner or operator of such an establishment
that is eligible under paragraph (6) may, from the list
published under paragraph (4), select an accredited person to
conduct such inspections.
(2) The Secretary shall publish in the Federal Register
criteria to accredit or deny accreditation to persons who
request to perform the duties specified in paragraph (1).
Thereafter, the Secretary shall inform those requesting
accreditation, within 60 days after the receipt of such
request, whether the request for accreditation is adequate for
review, and the Secretary shall promptly act on the request for
accreditation. Any resulting accreditation shall state that
such person is accredited to conduct inspections at device
establishments identified in paragraph (1). The accreditation
of such person shall specify the particular activities under
this subsection for which such person is accredited.
(3) An accredited person shall, at a minimum, meet the
following requirements:
(A) Such person may not be an employee of the Federal
Government.
(B) Such person shall be an independent organization
which is not owned or controlled by a manufacturer,
supplier, or vendor of articles regulated under this
Act and which has no organizational, material, or
financial affiliation (including a consultative
affiliation) with such a manufacturer, supplier, or
vendor.
(C) Such person shall be a legally constituted entity
permitted to conduct the activities for which it seeks
accreditation.
(D) Such person shall not engage in the design,
manufacture, promotion, or sale of articles regulated
under this Act.
(E) The operations of such person shall be in
accordance with generally accepted professional and
ethical business practices, and such person shall agree
in writing that at a minimum the person will--
(i) certify that reported information
accurately reflects data reviewed, inspection
observations made, other matters that relate to
or may influence compliance with this Act, and
recommendations made during an inspection or at
an inspection's closing meeting;
(ii) limit work to that for which competence
and capacity are available;
(iii) treat information received, records,
reports, and recommendations as confidential
commercial or financial information or trade
secret information, except such information may
be made available to the Secretary;
(iv) promptly respond and attempt to resolve
complaints regarding its activities for which
it is accredited; and
(v) protect against the use, in carrying out
paragraph (1), of any officer or employee of
the accredited person who has a financial
conflict of interest regarding any product
regulated under this Act, and annually make
available to the public disclosures of the
extent to which the accredited person, and the
officers and employees of the person, have
maintained compliance with requirements under
this clause relating to financial conflicts of
interest.
(F) Such person shall notify the Secretary of any
withdrawal, suspension, restriction, or expiration of
certificate of conformance with the quality systems
standard referred to in paragraph (7) for any device
establishment that such person inspects under this
subsection not later than 30 days after such
withdrawal, suspension, restriction, or expiration.
(G) Such person may conduct audits to establish
conformance with the quality systems standard referred
to in paragraph (7).
(4) The Secretary shall publish on the Internet site of the
Food and Drug Administration a list of persons who are
accredited under paragraph (2). Such list shall be updated to
ensure that the identity of each accredited person, and the
particular activities for which the person is accredited, is
known to the public. The updating of such list shall be no
later than one month after the accreditation of a person under
this subsection or the suspension or withdrawal of
accreditation, or the modification of the particular activities
for which the person is accredited.
(5)(A) To ensure that persons accredited under this
subsection continue to meet the standards of accreditation, the
Secretary shall (i) audit the performance of such persons on a
periodic basis through the review of inspection reports and
inspections by persons designated by the Secretary to evaluate
the compliance status of a device establishment and the
performance of accredited persons, and (ii) take such
additional measures as the Secretary determines to be
appropriate.
(B) The Secretary may withdraw accreditation of any person
accredited under paragraph (2), after providing notice and an
opportunity for an informal hearing, when such person is
substantially not in compliance with the standards of
accreditation, poses a threat to public health, fails to act in
a manner that is consistent with the purposes of this
subsection, or where the Secretary determines that there is a
financial conflict of interest in the relationship between the
accredited person and the owner or operator of a device
establishment that the accredited person has inspected under
this subsection. The Secretary may suspend the accreditation of
such person during the pendency of the process under the
preceding sentence.
(6)(A) Subject to subparagraphs (B) and (C), a device
establishment is eligible for inspection by persons accredited
under paragraph (2) if the following conditions are met:
(i) The Secretary classified the results of the most
recent inspection of the establishment as ``no action
indicated'' or ``voluntary action indicated''.
(ii) With respect to inspections of the establishment
to be conducted by an accredited person, the owner or
operator of the establishment submits to the Secretary
a notice that--
(I) provides the date of the last inspection
of the establishment by the Secretary and the
classification of that inspection;
(II) states the intention of the owner or
operator to use an accredited person to conduct
inspections of the establishment;
(III) identifies the particular accredited
person the owner or operator intends to select
to conduct such inspections; and
(IV) includes a certification that, with
respect to the devices that are manufactured,
prepared, propagated, compounded, or processed
in the establishment--
(aa) at least 1 of such devices is
marketed in the United States; and
(bb) at least 1 of such devices is
marketed, or is intended to be
marketed, in 1 or more foreign
countries, 1 of which countries
certifies, accredits, or otherwise
recognizes the person accredited under
paragraph (2) and identified under
subclause (III) as a person authorized
to conduct inspections of device
establishments.
(B)(i) Except with respect to the requirement of subparagraph
(A)(i), a device establishment is deemed to have clearance to
participate in the program and to use the accredited person
identified in the notice under subparagraph (A)(ii) for
inspections of the establishment unless the Secretary, not
later than 30 days after receiving such notice, issues a
response that--
(I) denies clearance to participate as provided under
subparagraph (C); or
(II) makes a request under clause (ii).
(ii) The Secretary may request from the owner or operator of
a device establishment in response to the notice under
subparagraph (A)(ii) with respect to the establishment, or from
the particular accredited person identified in such notice--
(I) compliance data for the establishment in
accordance with clause (iii)(I); or
(II) information concerning the relationship between
the owner or operator of the establishment and the
accredited person identified in such notice in
accordance with clause (iii)(II).
The owner or operator of the establishment, or such accredited
person, as the case may be, shall respond to such a request not
later than 60 days after receiving such request.
(iii)(I) The compliance data to be submitted by the owner or
operator of a device establishment in response to a request
under clause (ii)(I) are data describing whether the quality
controls of the establishment have been sufficient for ensuring
consistent compliance with current good manufacturing practice
within the meaning of section 501(h) and with other applicable
provisions of this Act. Such data shall include complete
reports of inspectional findings regarding good manufacturing
practice or other quality control audits that, during the
preceding 2-year period, were conducted at the establishment by
persons other than the owner or operator of the establishment,
together with all other compliance data the Secretary deems
necessary. Data under the preceding sentence shall demonstrate
to the Secretary whether the establishment has facilitated
consistent compliance by promptly correcting any compliance
problems identified in such inspections.
(II) A request to an accredited person under clause (ii)(II)
may not seek any information that is not required to be
maintained by such person in records under subsection (f)(1).
(iv) A device establishment is deemed to have clearance to
participate in the program and to use the accredited person
identified in the notice under subparagraph (A)(ii) for
inspections of the establishment unless the Secretary, not
later than 60 days after receiving the information requested
under clause (ii), issues a response that denies clearance to
participate as provided under subparagraph (C).
(C)(i) The Secretary may deny clearance to a device
establishment if the Secretary has evidence that the
certification under subparagraph (A)(ii)(IV) is untrue and the
Secretary provides to the owner or operator of the
establishment a statement summarizing such evidence.
(ii) The Secretary may deny clearance to a device
establishment if the Secretary determines that the
establishment has failed to demonstrate consistent compliance
for purposes of subparagraph (B)(iii)(I) and the Secretary
provides to the owner or operator of the establishment a
statement of the reasons for such determination.
(iii)(I) The Secretary may reject the selection of the
accredited person identified in the notice under subparagraph
(A)(ii) if the Secretary provides to the owner or operator of
the establishment a statement of the reasons for such
rejection. Reasons for the rejection may include that the
establishment or the accredited person, as the case may be, has
failed to fully respond to the request, or that the Secretary
has concerns regarding the relationship between the
establishment and such accredited person.
(II) If the Secretary rejects the selection of an accredited
person by the owner or operator of a device establishment, the
owner or operator may make an additional selection of an
accredited person by submitting to the Secretary a notice that
identifies the additional selection. Clauses (i) and (ii) of
subparagraph (B), and subclause (I) of this clause, apply to
the selection of an accredited person through a notice under
the preceding sentence in the same manner and to the same
extent as such provisions apply to a selection of an accredited
person through a notice under subparagraph (A)(ii).
(iv) In the case of a device establishment that is denied
clearance under clause (i) or (ii) or with respect to which the
selection of the accredited person is rejected under clause
(iii), the Secretary shall designate a person to review the
statement of reasons, or statement summarizing such evidence,
as the case may be, of the Secretary under such clause if,
during the 30-day period beginning on the date on which the
owner or operator of the establishment receives such statement,
the owner or operator requests the review. The review shall
commence not later than 30 days after the owner or operator
requests the review, unless the Secretary and the owner or
operator otherwise agree.
(7)(A) Persons accredited under paragraph (2) to conduct
inspections shall record in writing their inspection
observations and shall present the observations to the device
establishment's designated representative and describe each
observation. Additionally, such accredited person shall prepare
an inspection report in a form and manner designated by the
Secretary to conduct inspections, taking into consideration the
goals of international harmonization of quality systems
standards. Any official classification of the inspection shall
be determined by the Secretary.
(B) At a minimum, an inspection report under subparagraph (A)
shall identify the persons responsible for good manufacturing
practice compliance at the inspected device establishment, the
dates of the inspection, the scope of the inspection, and shall
describe in detail each observation identified by the
accredited person, identify other matters that relate to or may
influence compliance with this Act, and describe any
recommendations during the inspection or at the inspection's
closing meeting.
(C) An inspection report under subparagraph (A) shall be sent
to the Secretary and to the designated representative of the
inspected device establishment at the same time, but under no
circumstances later than three weeks after the last day of the
inspection. The report to the Secretary shall be accompanied by
all written inspection observations previously provided to the
designated representative of the establishment.
(D) Any statement or representation made by an employee or
agent of a device establishment to a person accredited under
paragraph (2) to conduct inspections shall be subject to
section 1001 of title 18, United States Code.
(E) If at any time during an inspection by an accredited
person the accredited person discovers a condition that could
cause or contribute to an unreasonable risk to the public
health, the accredited person shall immediately notify the
Secretary of the identification of the device establishment
subject to inspection and such condition.
(F) For the purpose of setting risk-based inspectional
priorities, the Secretary shall accept voluntary submissions of
reports of audits assessing conformance with appropriate
quality systems standards set by the International Organization
for Standardization (ISO) and identified by the Secretary in
public notice. If the owner or operator of an establishment
elects to submit audit reports under this subparagraph, the
owner or operator shall submit all such audit reports with
respect to the establishment during the preceding 2-year
periods.
(8) Compensation for an accredited person shall be determined
by agreement between the accredited person and the person who
engages the services of the accredited person, and shall be
paid by the person who engages such services.
(9) Nothing in this subsection affects the authority of the
Secretary to inspect any device establishment pursuant to this
Act.
(10)(A) For fiscal year 2005 and each subsequent fiscal year,
no device establishment may be inspected during the fiscal year
involved by a person accredited under paragraph (2) if--
(i) of the amounts appropriated for salaries and
expenses of the Food and Drug Administration for the
preceding fiscal year (referred to in this subparagraph
as the ``first prior fiscal year''), the amount
obligated by the Secretary for inspections of device
establishments by the Secretary was less than the
adjusted base amount applicable to such first prior
fiscal year; and
(ii) of the amounts appropriated for salaries and
expenses of the Food and Drug Administration for the
fiscal year preceding the first prior fiscal year
(referred to in this subparagraph as the ``second prior
fiscal year''), the amount obligated by the Secretary
for inspections of device establishments by the
Secretary was less than the adjusted base amount
applicable to such second prior fiscal year.
(B)(i) Subject to clause (ii), the Comptroller General of the
United States shall determine the amount that was obligated by
the Secretary for fiscal year 2002 for compliance activities of
the Food and Drug Administration with respect to devices
(referred to in this subparagraph as the ``compliance
budget''), and of such amount, the amount that was obligated
for inspections by the Secretary of device establishments
(referred to in this subparagraph as the ``inspection
budget'').
(ii) For purposes of determinations under clause (i), the
Comptroller General shall not include in the compliance budget
or the inspection budget any amounts obligated for inspections
of device establishments conducted as part of the process of
reviewing applications under section 515.
(iii) Not later than March 31, 2003, the Comptroller General
shall complete the determinations required in this subparagraph
and submit to the Secretary and the Congress a report
describing the findings made through such determinations.
(C) For purposes of this paragraph:
(i) The term ``base amount'' means the inspection
budget determined under subparagraph (B) for fiscal
year 2002.
(ii) The term ``adjusted base amount'', in the case
of applicability to fiscal year 2003, means an amount
equal to the base amount increased by 5 percent.
(iii) The term ``adjusted base amount'', with respect
to applicability to fiscal year 2004 or any subsequent
fiscal year, means the adjusted base amount applicable
to the preceding year increased by 5 percent.
(11) The authority provided by this subsection terminates on
[October 1, 2017] October 1, 2022.
(12) No later than four years after the enactment of this
subsection the Comptroller General shall 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--
(A) the number of inspections conducted by accredited
persons pursuant to this subsection and the number of
inspections conducted by Federal employees pursuant to
section 510(h) and of device establishments required to
register under section 510(i);
(B) the number of persons who sought accreditation
under this subsection, as well as the number of persons
who were accredited under this subsection;
(C) the reasons why persons who sought accreditation,
but were denied accreditation, were denied;
(D) the number of audits conducted by the Secretary
of accredited persons, the quality of inspections
conducted by accredited persons, whether accredited
persons are meeting their obligations under this Act,
and whether the number of audits conducted is
sufficient to permit these assessments;
(E) whether this subsection is achieving the goal of
ensuring more information about device establishment
compliance is being presented to the Secretary, and
whether that information is of a quality consistent
with information obtained by the Secretary pursuant to
inspections conducted by Federal employees;
(F) whether this subsection is advancing efforts to
allow device establishments to rely upon third-party
inspections for purposes of compliance with the laws of
foreign governments; and
(G) whether the Congress should continue, modify, or
terminate the program under this subsection.
(13) The Secretary shall include in the annual report
required under section 1003(g) the names of all accredited
persons and the particular activities under this subsection for
which each such person is accredited and the name of each
accredited person whose accreditation has been withdrawn during
the year.
(14) Notwithstanding any provision of this subsection, this
subsection does not have any legal effect on any agreement
described in section 803(b) between the Secretary and a foreign
country.
(15) Notwithstanding any other provision of this subsection,
for purposes of conducting inspections of establishments that
manufacture, prepare, propagate, compound, or process devices
except types of devices licensed under section 351 of the
Public Health Service Act, which inspections are required under
section 510(h) or are inspections of such establishments
required to register pursuant to section 510(i), the Secretary
may recognize auditing organizations that are recognized by
organizations established by governments to facilitate
international harmonization. Nothing in this paragraph affects
the authority of the Secretary to inspect any device
establishment pursuant to this Act. Nothing in this paragraph
affects the authority of the Secretary to determine the
official classification of an inspection.
(h)(1) In the case of inspections other than for-cause
inspections, the Secretary shall review processes and standards
applicable to inspections of domestic and foreign device
establishments in effect as of the date of the enactment of
this subsection, and update such processes and standards
through the adoption of uniform processes and standards
applicable to such inspections. Such processes and standards
shall provide for--
(A) exceptions to such processes and standards, as
appropriate;
(B) announcing the inspection of the establishment
within a reasonable time before such inspection occurs,
including by providing to the owner, operator, or agent
in charge of the establishment a notification regarding
the type and nature of the inspection;
(C) a reasonable estimate of the timeframe for the
inspection, an opportunity for advance communications
between the officers or employees carrying out the
inspection under subsection (a)(1) and the owner,
operator, or agent in charge of the establishment
concerning appropriate working hours during the
inspection, and, to the extent feasible, advance notice
of some records that will be requested in order to
expedite the inspection; and
(D) regular communications during the inspection with
the owner, operator, or agent in charge of the
establishment regarding inspection status, which may be
recorded by either party with advance notice and mutual
consent.
(2)(A) The Secretary shall, with respect to a request
described in subparagraph (B), provide nonbinding feedback with
respect to such request not later than 45 days after the
Secretary receives such request.
(B) A request described in this subparagraph is a request for
feedback--
(i) that is made by the owner, operator, or agent in
charge of such establishment in a timely manner; and
(ii) with respect to actions proposed to be taken by
a device establishment in a response to a report
received by such establishment pursuant to subsection
(b) that involve a public health priority, that
implicate systemic or major actions, or relate to
emerging safety issues (as determined by the
Secretary).
(3) Nothing in this subsection limits the authority of the
Secretary to conduct inspections otherwise permitted under this
Act in order to ensure compliance with this Act.
* * * * * * *
Subchapter C--Fees
* * * * * * *
PART 2--FEES RELATING TO DRUGS
* * * * * * *
SEC. 736. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--Beginning in [fiscal year 2013] fiscal
year 2018, the Secretary shall assess and collect fees in
accordance with this section as follows:
(1) Human drug application [and supplement] fee.--
(A) In general.--Each person that submits, on
or after September 1, 1992, a human drug
application [or a supplement] shall be subject
to a fee as follows:
(i) A fee established under
subsection [(c)(4)] (c)(5) for a human
drug application for which clinical
data (other than bioavailability or
bioequivalence studies) with respect to
safety or effectiveness are required
for approval.
(ii) [A fee established under
subsection (c)(4) for a human drug
application for which clinical data
with respect to safety or effectiveness
are not required or a supplement for
which clinical data (other than
bioavailability or bioequivalence
studies) with respect to safety or
effectiveness are required.] A fee
established under subsection (c)(5) for
a human drug application for which
clinical data (other than
bioavailability or bioequivalence
studies) with respect to safety or
effectiveness are not required for
approval. Such fee shall be half of the
amount of the fee established under
clause (i).
(B) Payment.--The fee required by
subparagraph (A) shall be due upon submission
of the application [or supplement].
(C) Exception for previously filed
application [or supplement].--If a human drug
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 human drug
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).
(D) Refund of fee if application refused for
filing or withdrawn before filing.--The
Secretary shall refund 75 percent of the fee
paid under subparagraph (B) for any application
[or supplement] which is refused for filing or
withdrawn without a waiver before filing.
(E) Fees for applications previously refused
for filing or withdrawn before filing.--A human
drug 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 or
reduced under subsection (d).
(F) Exception for designated orphan drug [or
indication].--A human drug application for a
prescription drug product that has been
designated as a drug for a rare disease or
condition pursuant to section 526 shall not be
subject to a fee under subparagraph (A), unless
the human drug application includes an
indication for other than a rare disease or
condition. [A supplement proposing to include a
new indication for a rare disease or condition
in a human drug application shall not be
subject to a fee under subparagraph (A), if the
drug has been designated pursuant to section
526 as a drug for a rare disease or condition
with regard to the indication proposed in such
supplement.]
(G) Refund of fee if application withdrawn.--
If an application [or supplement] is withdrawn
after the application [or supplement] was
filed, the Secretary may refund the fee or a
portion of the fee if no substantial work was
performed on the application [or supplement]
after the application [or supplement] was
filed. The Secretary shall have the sole
discretion to refund a fee or a portion of the
fee under this subparagraph. A determination by
the Secretary concerning a refund under this
paragraph shall not be reviewable.
[(2) Prescription drug establishment fee.--
[(A) In general.--Except as provided in
subparagraphs (B) and (C), each person that--
[(i) is named as the applicant in a
human drug application; and
[(ii) after September 1, 1992, had
pending before the Secretary a human
drug application or supplement,
shall be assessed an annual fee established
under subsection (c)(4) for each prescription
drug establishment listed in its approved human
drug application as an establishment that
manufactures the prescription drug product
named in the application. The annual
establishment fee shall be assessed in each
fiscal year in which the prescription drug
product named in the application is assessed a
fee under paragraph (3) unless the prescription
drug establishment listed in the application
does not engage in the manufacture of the
prescription drug product during the fiscal
year. The establishment fee shall be 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. Each such establishment
shall be assessed only one fee per
establishment, notwithstanding the number of
prescription drug products manufactured at the
establishment. In the event an establishment is
listed in a human drug application by more than
one applicant, the establishment fee for the
fiscal year shall be divided equally and
assessed among the applicants whose
prescription drug products are manufactured by
the establishment during the fiscal year and
assessed product fees under paragraph (3).
[(B) Exception.--If, during the fiscal year,
an applicant initiates or causes to be
initiated the manufacture of a prescription
drug product at an establishment listed in its
human drug application--
[(i) that did not manufacture the
product in the previous fiscal year;
and
[(ii) for which the full
establishment fee has been assessed in
the fiscal year at a time before
manufacture of the prescription drug
product was begun;
the applicant will not be assessed a share of
the establishment fee for the fiscal year in
which the manufacture of the product began.
[(C) Special rules for positron emission
tomography drugs.--
[(i) In general.--Except as provided
in clause (ii), each person who is
named as the applicant in an approved
human drug application for a positron
emission tomography drug shall be
subject under subparagraph (A) to one-
sixth of an annual establishment fee
with respect to each such establishment
identified in the application as
producing positron emission tomography
drugs under the approved application.
[(ii) Exception from annual
establishment fee.--Each person who is
named as the applicant in an
application described in clause (i)
shall not be assessed an annual
establishment fee for a fiscal year if
the person certifies to the Secretary,
at a time specified by the Secretary
and using procedures specified by the
Secretary, that--
[(I) the person is a not-for-
profit medical center that has
only 1 establishment for the
production of positron emission
tomography drugs; and
[(II) at least 95 percent of
the total number of doses of
each positron emission
tomography drug produced by
such establishment during such
fiscal year will be used within
the medical center.
[(iii) Definition.--For purposes of
this subparagraph, the term ``positron
emission tomography drug'' has the
meaning given to the term ``compounded
positron emission tomography drug'' in
section 201(ii), except that paragraph
(1)(B) of such section shall not apply.
[(3)] (2) Prescription drug [product fee] program
fee.--
(A) In general.--[Except as provided in
subparagraph (B), each person who is named as
the applicant in a human drug application, and
who, after September 1, 1992, had pending
before the Secretary a human drug application
or supplement, shall pay for each such
prescription drug product the annual fee
established under subsection (c)(4).] Except as
provided in subparagraphs (B) and (C), each
person who is named as the applicant in a human
drug application, and who, after September 1,
1992, had pending before the Secretary a human
drug application or supplement, shall pay the
annual prescription drug program fee
established for a fiscal year under subsection
(c)(5) for each prescription drug product that
is identified in such a human drug application
approved as of October 1 of such fiscal year.
Such fee shall be 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. Such fee
shall be paid only once for each product for a
fiscal year in which the fee is payable.
(B) Exception for certain prescription drug
products.--[A prescription drug product shall
not be assessed a fee] A prescription drug
program fee shall not be assessed for a
prescription drug product under subparagraph
(A) if such product is--
(i) identified on the list compiled
under section 505(j)(7) with a potency
described in terms of per 100 mL;
(ii) the same product as another
product that--
(I) was approved under an
application filed under section
505(b) or 505(j); and
(II) is not in the list of
discontinued products compiled
under section 505(j)(7);
(iii) the same product as another
product that was approved under an
abbreviated application filed under
section 507 (as in effect on the day
before the date of enactment of the
Food and Drug Administration
Modernization Act of 1997); or
(iv) the same product as another
product that was approved under an
abbreviated new drug application
pursuant to regulations in effect prior
to the implementation of the Drug Price
Competition and Patent Term Restoration
Act of 1984.
(C) Limitation.--A person who is named as the
applicant in an approved human drug application
shall not be assessed more than 5 prescription
drug program fees for a fiscal year for
prescription drug products identified in such
approved human drug application.
[(b) Fee Revenue Amounts.--
[(1) In general.--For each of the fiscal years 2013
through 2017, fees under subsection (a) shall, except
as provided in subsections (c), (d), (f), and (g), be
established to generate a total revenue amount under
such subsection that is equal to the sum of--
[(A) $693,099,000;
[(B) the dollar amount equal to the inflation
adjustment for fiscal year 2013 (as determined
under paragraph (3)(A)); and
[(C) the dollar amount equal to the workload
adjustment for fiscal year 2013 (as determined
under paragraph (3)(B)).
[(2) Types of fees.--Of the total revenue amount
determined for a fiscal year under paragraph (1)--
[(A) one-third shall be derived from fees
under subsection (a)(1) (relating to human drug
applications and supplements);
[(B) one-third shall be derived from fees
under subsection (a)(2) (relating to
prescription drug establishments); and
[(C) one-third shall be derived from fees
under subsection (a)(3) (relating to
prescription drug products).
[(3) Fiscal year 2013 inflation and workload
adjustments.--For purposes of paragraph (1), the dollar
amount of the inflation and workload adjustments for
fiscal year 2013 shall be determined as follows:
[(A) Inflation adjustment.--The inflation
adjustment for fiscal year 2013 shall be the
sum of--
[(i) $652,709,000 multiplied by the
result of an inflation adjustment
calculation determined using the
methodology described in subsection
(c)(1)(B); and
[(ii) $652,709,000 multiplied by the
result of an inflation adjustment
calculation determined using the
methodology described in subsection
(c)(1)(C).
[(B) Workload adjustment.--Subject to
subparagraph (C), the workload adjustment for
fiscal 2013 shall be--
[(i) $652,709,000 plus the amount of
the inflation adjustment calculated
under subparagraph (A); multiplied by
[(ii) the amount (if any) by which a
percentage workload adjustment for
fiscal year 2013, as determined using
the methodology described in subsection
(c)(2)(A), would exceed the percentage
workload adjustment (as so determined)
for fiscal year 2012, if both such
adjustment percentages were calculated
using the 5-year base period consisting
of fiscal years 2003 through 2007.
[(C) Limitation.--Under no circumstances
shall the adjustment under subparagraph (B)
result in fee revenues for fiscal year 2013
that are less than the sum of the amount under
paragraph (1)(A) and the amount under paragraph
(1)(B).
[(c) Adjustments.--
[(1) Inflation adjustment.--For fiscal year 2014 and
subsequent fiscal years, the revenues established in
subsection (b) shall be adjusted by the Secretary by
notice, published in the Federal Register, for a fiscal
year by the amount equal to the sum of--
[(A) one;
[(B) the average annual percent change in the
cost, per full-time equivalent position of the
Food and Drug Administration, of all personnel
compensation and benefits paid with respect to
such positions for the first 3 years of the
preceding 4 fiscal years, multiplied by the
proportion of personnel compensation and
benefits costs to total costs of the process
for the review of human drug applications (as
defined in section 735(6)) for the first 3
years of the preceding 4 fiscal years, and
[(C) the average annual percent change that
occurred in the Consumer Price Index for urban
consumers (Washington-Baltimore, DC-MD-VA-WV;
Not Seasonally Adjusted; All items; Annual
Index) for the first 3 years of the preceding 4
years of available data multiplied by the
proportion of all costs other than personnel
compensation and benefits costs to total costs
of the process for the review of human drug
applications (as defined in section 735(6)) for
the first 3 years of the preceding 4 fiscal
years.
The adjustment made each fiscal year under this
paragraph shall be added on a compounded basis to the
sum of all adjustments made each fiscal year after
fiscal year 2013 under this paragraph.
[(2) Workload adjustment.--For fiscal year 2014 and
subsequent fiscal years, after the fee revenues
established in subsection (b) are adjusted for a fiscal
year for inflation in accordance with paragraph (1),
the fee revenues shall be adjusted further for such
fiscal year to reflect changes in the workload of the
Secretary for the process for the review of human drug
applications. With respect to such adjustment:
[(A) The adjustment shall be determined by
the Secretary based on a weighted average of
the change in the total number of human drug
applications (adjusted for changes in review
activities, as described in the notice that the
Secretary is required to publish in the Federal
Register under this subparagraph), efficacy
supplements, and manufacturing supplements
submitted to the Secretary, and the change in
the total number of active commercial
investigational new drug applications (adjusted
for changes in review activities, as so
described) during the most recent 12-month
period for which data on such submissions is
available. The Secretary shall publish in the
Federal Register the fee revenues and fees
resulting from the adjustment and the
supporting methodologies.
[(B) Under no circumstances shall the
adjustment result in fee revenues for a fiscal
year that are less than the sum of the amount
under subsection (b)(1)(A) and the amount under
subsection (b)(1)(B), as adjusted for inflation
under paragraph (1).
[(C) The Secretary shall contract with an
independent accounting or consulting firm to
periodically review the adequacy of the
adjustment and publish the results of those
reviews. The first review shall be conducted
and published by the end of fiscal year 2013
(to examine the performance of the adjustment
since fiscal year 2009), and the second review
shall be conducted and published by the end of
fiscal year 2015 (to examine the continued
performance of the adjustment). The reports
shall evaluate whether the adjustment
reasonably represents actual changes in
workload volume and complexity and present
options to discontinue, retain, or modify any
elements of the adjustment. The reports shall
be published for public comment. After review
of the reports and receipt of public comments,
the Secretary shall, if warranted, adopt
appropriate changes to the methodology. If the
Secretary adopts changes to the methodology
based on the first report, the changes shall be
effective for the first fiscal year for which
fees are set after the Secretary adopts such
changes and each subsequent fiscal year.
[(3) Final year adjustment.--For fiscal year 2017,
the Secretary may, in addition to adjustments under
this paragraph and paragraphs (1) and (2), further
increase the fee revenues and fees established in
subsection (b) if such an adjustment is necessary to
provide for not more than 3 months of operating
reserves of carryover user fees for the process for the
review of human drug applications for the first 3
months of fiscal year 2018. If such an adjustment is
necessary, the rationale for the amount of the increase
shall be contained in the annual notice establishing
fee revenues and fees for fiscal year 2017. If the
Secretary has carryover balances for such process in
excess of 3 months of such operating reserves, the
adjustment under this paragraph shall not be made.
[(4) Annual fee setting.--The Secretary shall, not
later than 60 days before the start of each fiscal year
that begins after September 30, 2012, establish, for
the next fiscal year, application, product, and
establishment fees under subsection (a), based on the
revenue amounts established under subsection (b) and
the adjustments provided under this subsection.
[(5) Limit.--The total amount of fees charged, as
adjusted under this subsection, for a fiscal year may
not exceed the total costs for such fiscal year for the
resources allocated for the process for the review of
human drug applications.]
(b) Fee Revenue Amounts.--
(1) In general.--For each of the fiscal years 2018
through 2022, fees under subsection (a) shall, except
as provided in subsections (c), (d), (f), and (g), be
established to generate a total revenue amount under
such subsection that is equal to the sum of--
(A) the annual base revenue for the fiscal
year (as determined under paragraph (3));
(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined
under subsection (c)(1));
(C) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as
determined under subsection (c)(2));
(D) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if
applicable (as determined under subsection
(c)(3));
(E) the dollar amount equal to the additional
direct cost adjustment for the fiscal year (as
determined under subsection (c)(4)); and
(F) additional dollar amounts for each fiscal
year as follows:
(i) $20,077,793 for fiscal year 2018.
(ii) $21,317,472 for fiscal year
2019.
(iii) $16,953,329 for fiscal year
2020.
(iv) $5,426,896 for fiscal year 2021.
(v) $2,769,609 for fiscal year 2022.
(2) Types of fees.--Of the total revenue amount
determined for a fiscal year under paragraph (1)--
(A) 20 percent shall be derived from human
drug application fees under subsection (a)(1);
and
(B) 80 percent shall be derived from
prescription drug program fees under subsection
(a)(2).
(3) Annual base revenue.--For purposes of paragraph
(1), the dollar amount of the annual base revenue for a
fiscal year shall be--
(A) for fiscal year 2018, $878,590,000; and
(B) for fiscal years 2019 through 2022, the
dollar amount of the total revenue amount
established under paragraph (1) for the
previous fiscal year, not including any
adjustments made under subsection (c)(3) or
(c)(4).
(c) Adjustments; Annual Fee Setting.--
(1) Inflation adjustment.--
(A) In general.--For purposes of subsection
(b)(1)(B), the dollar amount of the inflation
adjustment to the annual base revenue for each
fiscal year shall be equal to the product of--
(i) such annual base revenue for the
fiscal year under subsection (b)(1)(A);
and
(ii) the inflation adjustment
percentage under subparagraph (B).
(B) Inflation adjustment percentage.--The
inflation adjustment percentage under this
subparagraph for a fiscal year is equal to the
sum of--
(i) the average annual percent change
in the cost, per full-time equivalent
position of the Food and Drug
Administration, of all personnel
compensation and benefits paid with
respect to such positions for the first
3 years of the preceding 4 fiscal
years, multiplied by 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
(ii) the average annual percent
change that occurred in the Consumer
Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not
Seasonally Adjusted; All items; Annual
Index) for the first 3 years of the
preceding 4 years of available data
multiplied by 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.
(2) Capacity planning adjustment.--
(A) In general.--For each fiscal year, after
the annual base revenue established in
subsection (b)(1)(A) is adjusted for inflation
in accordance with paragraph (1), such revenue
shall be adjusted further for such fiscal year,
in accordance with this paragraph, to reflect
changes in the resource capacity needs of the
Secretary for the process for the review of
human drug applications.
(B) Interim methodology.--
(i) In general.--Until the capacity
planning methodology described in
subparagraph (C) is effective, the
adjustment under this paragraph for a
fiscal year shall be based on the
product of--
(I) the annual base revenue
for such year, as adjusted for
inflation under paragraph (1);
and
(II) the adjustment
percentage under clause (ii).
(ii) Adjustment percentage.--The
adjustment percentage under this clause
for a fiscal year is the weighted
change in the 3-year average ending in
the most recent year for which data are
available, over the 3-year average
ending in the previous year, for--
(I) the total number of human
drug applications, efficacy
supplements, and manufacturing
supplements submitted to the
Secretary;
(II) the total number of
active commercial
investigational new drug
applications; and
(III) the total number of
formal meetings scheduled by
the Secretary, and written
responses issued by the
Secretary in lieu of such
formal meetings, as identified
in section I.H of the letters
described in section 101(b) of
the Prescription Drug User Fee
Amendments of 2017.
(C) Capacity planning methodology.--
(i) Development; evaluation and
report.--The Secretary shall obtain,
through a contract with an independent
accounting or consulting firm, a report
evaluating options and recommendations
for a new methodology to accurately
assess changes in the resource and
capacity needs of the process for the
review of human drug applications. The
capacity planning methodological
options and recommendations presented
in such report shall utilize and be
informed by personnel time reporting
data as an input. The report shall be
published for public comment no later
than the end of fiscal year 2020.
(ii) Establishment and
implementation.--After review of the
report described in clause (i) and any
public comments thereon, the Secretary
shall establish a capacity planning
methodology for purposes of this
paragraph, which shall--
(I) replace the interim
methodology under subparagraph
(B);
(II) incorporate such
approaches and attributes as
the Secretary determines
appropriate; and
(III) be effective beginning
with the first fiscal year for
which fees are set after such
capacity planning methodology
is established.
(D) Limitation.--Under no circumstances shall
an adjustment under this paragraph result in
fee revenue for a fiscal year that is less than
the sum of the amounts under subsections
(b)(1)(A) (the annual base revenue for the
fiscal year) and (b)(1)(B) (the dollar amount
of the inflation adjustment for the fiscal
year).
(E) Publication in federal register.--The
Secretary shall publish in the Federal Register
notice under paragraph (5) the fee revenue and
fees resulting from the adjustment and the
methodologies under this paragraph.
(3) Operating reserve adjustment.--
(A) Increase.--For fiscal year 2018 and
subsequent fiscal years, the Secretary may, in
addition to adjustments under paragraphs (1)
and (2), further increase the fee revenue and
fees if such an adjustment is necessary to
provide for not more than 14 weeks of operating
reserves of carryover user fees for the process
for the review of human drug applications.
(B) Decrease.--If the Secretary has carryover
balances for such process in excess of 14 weeks
of such operating reserves, the Secretary shall
decrease such fee revenue and fees to provide
for not more than 14 weeks of such operating
reserves.
(C) Notice of rationale.--If an adjustment
under subparagraph (A) or (B) is made, the
rationale for the amount of the increase or
decrease (as applicable) in fee revenue and
fees shall be contained in the annual Federal
Register notice under paragraph (5)
establishing fee revenue and fees for the
fiscal year involved.
(4) Additional direct cost adjustment.--
(A) In general.--The Secretary shall, in
addition to adjustments under paragraphs (1),
(2), and (3), further increase the fee revenue
and fees--
(i) for fiscal year 2018, by
$8,730,000; and
(ii) for fiscal year 2019 and
subsequent fiscal years, by the amount
determined under subparagraph (B).
(B) Amount.--The amount determined under this
subparagraph is--
(i) $8,730,000, multiplied by
(ii) the Consumer Price Index for
urban consumers (Washington-Baltimore,
DC-MD-VA-WV; Not Seasonally Adjusted;
All Items; Annual Index) for the most
recent year of available data, divided
by such Index for 2016.
(5) Annual fee setting.--The Secretary shall, not
later than 60 days before the start of each fiscal year
that begins after September 30, 2017--
(A) establish, for the next fiscal year,
human drug application fees and prescription
drug program fees under subsection (a), based
on the revenue amounts established under
subsection (b) and the adjustments provided
under this subsection; and
(B) publish such fee revenue and fees in the
Federal Register.
(6) Limit.--The total amount of fees charged, as
adjusted under this subsection, for a fiscal year may
not exceed the total costs for such fiscal year for the
resources allocated for the process for the review of
human drug applications.
(d) Fee Waiver or Reduction.--
(1) In general.--The Secretary shall grant to a
person who is named as the applicant in a human drug
application a waiver from or a reduction of one or more
fees assessed to that person under subsection (a) where
the Secretary finds that--
(A) such waiver or reduction is necessary to
protect the public health,
(B) the assessment of the fee would present a
significant barrier to innovation because of
limited resources available to such person or
other circumstances, or
[(C) the fees to be paid by such person will
exceed the anticipated present and future costs
incurred by the Secretary in conducting the
process for the review of human drug
applications for such person, or]
[(D)] (C) the applicant involved is a small
business submitting its first human drug
application to the Secretary for review.
(2) Considerations.--In determining whether to grant
a waiver or reduction of a fee under paragraph (1), the
Secretary shall consider only the circumstances and
assets of the applicant involved and any affiliate of
the applicant.
[(3) Use of standard costs.--In making the finding in
paragraph (1)(C), the Secretary may use standard
costs.]
[(4)] (3) Rules relating to small businesses.--
(A) Definition.--In [paragraph (1)(D)]
paragraph (1)(C), the term ``small business''
means an entity that has fewer than 500
employees, including employees of affiliates,
and that does not have a drug product that has
been approved under a human drug application
and introduced or delivered for introduction
into interstate commerce.
(B) Waiver of application fee.--The Secretary
shall waive under [paragraph (1)(D)] paragraph
(1)(C) the application fee for the first human
drug 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--]
[(i)] [application fees] shall pay
application fees for all subsequent
human drug applications submitted to
the Secretary for review in the same
manner as an entity that does not
qualify as a small business[; and].
[(ii) all supplement fees for all
supplements to human drug applications
submitted to the Secretary for review
in the same manner as an entity that
does not qualify as a small business.]
(e) Effect of Failure To Pay Fees.--A human drug 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] all such
fees owed by such person have been paid.
(f) Limitations.--
(1) In general.--Fees under subsection (a) shall be
refunded for a fiscal year beginning after fiscal year
1997 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 the fiscal year 1997
(excluding the amount of fees appropriated for such
fiscal year) multiplied by the adjustment factor
applicable to the fiscal year involved.
(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal
year because of paragraph (1) 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 human drug
applications and [supplements, prescription drug
establishments, and prescription drug products]
prescription drug program fees at any time in such
fiscal year notwithstanding the provisions of
subsection (a) relating to the date fees are to be
paid.
(g) Crediting and Availability of Fees.--
(1) In general.--Subject to paragraph (2)(C), 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 human drug applications.
(2) Collections and appropriation acts.--
(A) In general.--The fees authorized by this
section--
(i) subject to subparagraph (C),
shall be collected and available in
each fiscal year in an amount not to
exceed the amount specified in
appropriation Acts, or otherwise made
available for obligation, for such
fiscal year, and
(ii) shall be available to defray
increases in the costs of the resources
allocated for the process for the
review of human drug applications
(including increases in 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) over such
costs, excluding costs paid from fees
collected under this section, for
fiscal year 1997 multiplied by the
adjustment factor.
(B) Compliance.--The Secretary shall be
considered to have met the requirements of
subparagraph (A)(ii) in any fiscal year if the
costs funded by appropriations and allocated
for the process for the review of human drug
applications--
(i) are not more than 3 percent below
the level specified in subparagraph
(A)(ii); or
(ii)(I) are more than 3 percent below
the level specified in subparagraph
(A)(ii), and fees assessed for the
fiscal year following the subsequent
fiscal year are decreased by the amount
in excess of 3 percent by which such
costs fell below the level specified in
such subparagraph; and
(II) such costs are not more than 5
percent below the level specified in
such subparagraph.
(C) Provision for early payments.--Payment of
fees authorized under this section for a fiscal
year, prior to the due date for such fees, may
be accepted by the Secretary in accordance with
authority provided in advance in a prior year
appropriations Act.
(3) Authorization of appropriations.--For each of the
fiscal years [2013 through 2017] 2018 through 2022,
there is authorized to be appropriated for fees under
this section an amount equal to the total revenue
amount determined under subsection (b) for the fiscal
year, as adjusted or otherwise affected under
subsection (c) [and paragraph (4) of this subsection].
[(4) Offset.--If the sum of the cumulative amount of
fees collected under this section for the fiscal years
2013 through 2015 and the amount of fees estimated to
be collected under this section for fiscal year 2016
exceeds the cumulative amount appropriated under
paragraph (3) for the fiscal years 2013 through 2016,
the excess shall be credited to the appropriation
account of the Food and Drug Administration as provided
in paragraph (1), and shall be subtracted from the
amount of fees that would otherwise be authorized to be
collected under this section pursuant to appropriation
Acts for fiscal year 2017.]
(h) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States Code.
(i) Written Requests for Waivers, Reductions, and Refunds.--
To qualify for consideration for a waiver or reduction under
subsection (d), or for a refund of any fee collected in
accordance with subsection (a), a person shall submit to the
Secretary a written request for such waiver, reduction, or
refund not later than 180 days after such fee is due.
(j) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employers, and advisory committees not engaged in the process
of the review of human drug applications, be reduced to offset
the number of officers, employees, and advisory committees so
engaged.
(k) Orphan Drugs.--
(1) Exemption.--A drug designated under section 526
for a rare disease or condition and approved under
section 505 or under section 351 of the Public Health
Service Act shall be exempt from [product and
establishment fees] prescription drug program fees
under this section, if the drug meets all of the
following conditions:
(A) The drug meets the public health
requirements contained in this Act as such
requirements are applied to requests for
waivers for [product and establishment fees]
prescription drug program fees.
(B) The drug is owned or licensed and is
marketed by a company that had less than
$50,000,000 in gross worldwide revenue during
the previous year.
(2) Evidence of qualification.--An exemption under
paragraph (1) applies with respect to a drug only if
the applicant involved submits a certification that its
gross annual revenues did not exceed $50,000,000 for
the preceding 12 months before the exemption was
requested.
* * * * * * *
SEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Report.--
(1) In general.--Beginning with fiscal year [2013]
2018, not later than 120 days after the end of each
fiscal year for which fees are collected under this
part, the Secretary shall prepare and submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a report concerning--
(A) the progress of the Food and Drug
Administration in achieving the goals
identified in the letters described in section
101(b) of the [Prescription Drug User Fee
Amendments of 2012] Prescription Drug User Fee
Amendments of 2017 during such fiscal year and
the future plans of the Food and Drug
Administration for meeting the goals, including
the status of the independent assessment
described in such letters; and
(B) the progress of the Center for Drug
Evaluation and Research and the Center for
Biologics Evaluation and Research in achieving
the goals, and future plans for meeting the
goals, including, for each review division--
(i) the number of original standard
new drug applications and biologics
license applications filed per fiscal
year for each review division;
(ii) the number of original priority
new drug applications and biologics
license applications filed per fiscal
year for each review division;
(iii) the number of standard efficacy
supplements filed per fiscal year for
each review division;
(iv) the number of priority efficacy
supplements filed per fiscal year for
each review division;
(v) the number of applications filed
for review under accelerated approval
per fiscal year for each review
division;
(vi) the number of applications filed
for review as fast track products per
fiscal year for each review division;
(vii) the number of applications
filed for orphan-designated products
per fiscal year for each review
division; and
(viii) the number of breakthrough
designations for a fiscal year for each
review division.
(2) Inclusion.--The report under this subsection for
a fiscal year shall include information on all previous
cohorts for which the Secretary has not given a
complete response on all human drug applications and
supplements in the cohort.
(b) Fiscal Report.--Beginning with fiscal year [2013] 2018,
not later than 120 days after the end of each fiscal year for
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected for such fiscal year.
(c) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to the
public on the Internet Web site of the Food and Drug
Administration.
(d) Reauthorization.--
(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals, and
plans for meeting the goals, for the process for the
review of human drug applications for the first 5
fiscal years after fiscal year [2017] 2022, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
(A) the Committee on Energy and Commerce of
the House of Representatives;
(B) the Committee on Health, Education,
Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer
advocacy groups; and
(F) the regulated industry.
(2) Prior public input.--Prior to beginning
negotiations with the regulated industry on the
reauthorization of this part, the Secretary shall--
(A) publish a notice in the Federal Register
requesting public input on the reauthorization;
(B) hold a public meeting at which the public
may present its views on the reauthorization,
including specific suggestions for changes to
the goals referred to in subsection (a);
(C) provide a period of 30 days after the
public meeting to obtain written comments from
the public suggesting changes to this part; and
(D) publish the comments on the Food and Drug
Administration's Internet Web site.
(3) Periodic consultation.--Not less frequently than
once every month during negotiations with the regulated
industry, the Secretary shall hold discussions with
representatives of patient and consumer advocacy groups
to continue discussions of their views on the
reauthorization and their suggestions for changes to
this part as expressed under paragraph (2).
(4) Public review of recommendations.--After
negotiations with the regulated industry, the Secretary
shall--
(A) present the recommendations developed
under paragraph (1) to the Congressional
committees specified in such paragraph;
(B) publish such recommendations in the
Federal Register;
(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
(D) hold a meeting at which the public may
present its views on such recommendations; and
(E) after consideration of such public views
and comments, revise such recommendations as
necessary.
(5) Transmittal of recommendations.--Not later than
January 15, [2017] 2022, the Secretary shall transmit
to the Congress the revised recommendations under
paragraph (4), a summary of the views and comments
received under such paragraph, and any changes made to
the recommendations in response to such views and
comments.
(6) Minutes of negotiation meetings.--
(A) Public availability.--Before presenting
the recommendations developed under paragraphs
(1) through (5) to the Congress, the Secretary
shall make publicly available, on the public
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 regulated industry.
(B) Content.--The minutes described under
subparagraph (A) shall summarize any
substantive proposal made by any party to the
negotiations as well as significant
controversies or differences of opinion during
the negotiations and their resolution.
PART 3--FEES RELATING TO DEVICES
SEC. 737. DEFINITIONS.
For purposes of this part:
(1) The term ``premarket application'' means--
(A) an application for approval of a device
submitted under section 515(c) or section 351
of the Public Health Service Act; or
(B) a product development protocol described
in section 515(f).
Such term does not include a supplement, a premarket
report, or a premarket notification submission.
(2) The term ``premarket report'' means a report
submitted under section 515(c)(2).
(3) The term ``premarket notification submission''
means a report submitted under section 510(k).
(4)(A) The term ``supplement'', with respect to a
panel-track supplement, a 180-day supplement, a real-
time supplement, or an efficacy supplement, means a
request to the Secretary to approve a change in a
device for which--
(i) an application or report has been
approved under section 515(d), or an
application has been approved under section 351
of the Public Health Service Act; or
(ii) a notice of completion has become
effective under section 515(f).
(B) The term ``panel-track supplement'' means a
supplement to an approved premarket application or
premarket report under section 515 that requests a
significant change in design or performance of the
device, or a new indication for use of the device, and
for which substantial clinical data are necessary to
provide a reasonable assurance of safety and
effectiveness.
(C) The term ``180-day supplement'' means a
supplement to an approved premarket application or
premarket report under section 515 that is not a panel-
track supplement and requests a significant change in
components, materials, design, specification, software,
color additives, or labeling.
(D) The term ``real-time supplement'' means a
supplement to an approved premarket application or
premarket report under section 515 that requests a
minor change to the device, such as a minor change to
the design of the device, software, sterilization, or
labeling, and for which the applicant has requested and
the agency has granted a meeting or similar forum to
jointly review and determine the status of the
supplement.
(E) The term ``efficacy supplement'' means a
supplement to an approved premarket application under
section 351 of the Public Health Service Act that
requires substantive clinical data.
(5) The term ``30-day notice'' means a notice under
section 515(d)(5) that is limited to a request to make
modifications to manufacturing procedures or methods of
manufacture affecting the safety and effectiveness of
the device.
(6) The term ``request for classification
information'' means a request made under section 513(g)
for information respecting the class in which a device
has been classified or the requirements applicable to a
device.
(7) The term ``annual fee'', for periodic reporting
concerning a class III device, means the annual fee
associated with periodic reports required by a
premarket application approval order.
(8) The term ``de novo classification request'' means
a request made under section 513(f)(2)(A) with respect
to the classification of a device.
[(8)] (9) The term ``process for the review of device
applications'' means the following activities of the
Secretary with respect to the review of premarket
applications, premarket reports, supplements, and
premarket notification submissions:
(A) The activities necessary for the review
of premarket applications, premarket reports,
supplements, and premarket notification
submissions.
(B) The issuance of action letters that allow
the marketing of devices or which set forth in
detail the specific deficiencies in such
applications, reports, supplements, or
submissions and, where appropriate, the actions
necessary to place them in condition for
approval.
(C) The inspection of manufacturing
establishments and other facilities undertaken
as part of the Secretary's review of pending
premarket applications, premarket reports, and
supplements.
(D) Monitoring of research conducted in
connection with the review of such
applications, reports, supplements, and
submissions.
(E) Review of device applications subject to
section 351 of the Public Health Service Act
for an investigational new drug application
under section 505(i) or for an investigational
device exemption under section 520(g) and
activities conducted in anticipation of the
submission of such applications under section
505(i) or 520(g).
(F) The development of guidance, policy
documents, or regulations to improve the
process for the review of premarket
applications, premarket reports, supplements,
and premarket notification submissions.
(G) The development of voluntary test
methods, consensus standards, or mandatory
performance standards under section 514 in
connection with the review of such
applications, reports, supplements, or
submissions and related activities.
(H) The provision of technical assistance to
device manufacturers in connection with the
submission of such applications, reports,
supplements, or submissions.
(I) Any activity undertaken under section 513
or 515(i) in connection with the initial
classification or reclassification of a device
or under section 515(b) in connection with any
requirement for approval of a device.
(J) Evaluation of postmarket studies required
as a condition of an approval of a premarket
application or premarket report under section
515 or a premarket application under section
351 of the Public Health Service Act.
(K) Compiling, developing, and reviewing
information on relevant devices to identify
safety and effectiveness issues for devices
subject to premarket applications, premarket
reports, supplements, or premarket notification
submissions.
[(9)] (10) The term ``costs of resources allocated
for the process for the review of device applications''
means the expenses in connection with the process for
the review of device applications for--
(A) officers and employees of the Food and
Drug Administration, contractors of the Food
and Drug Administration, advisory committees,
and costs related to such officers, employees,
and committees and to contracts with such
contractors;
(B) management of information, and the
acquisition, maintenance, and repair of
computer resources;
(C) leasing, maintenance, renovation, and
repair of facilities and acquisition,
maintenance, and repair of fixtures, furniture,
scientific equipment, and other necessary
materials and supplies; and
(D) collecting fees and accounting for
resources allocated for the review of premarket
applications, premarket reports, supplements,
[and submissions] submissions, and de novo
classification requests.
[(10)] (11) The term ``adjustment factor'' applicable
to a fiscal year 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] 2016.
[(11)] (12) The term ``person'' includes an affiliate
thereof.
[(12)] (13) The term ``affiliate'' means a business
entity that has a relationship with a second business
entity (whether domestic or international) if, directly
or indirectly--
(A) one business entity controls, or has the
power to control, the other business entity; or
(B) a third party controls, or has power to
control, both of the business entities.
[(13)] (14) The term ``establishment subject to a
registration fee'' means an establishment that is
registered (or is required to register) with the
Secretary under section 510 because such establishment
is engaged in the manufacture, preparation,
propagation, compounding, or processing of a device.
SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES.
(a) Types of Fees.--
(1) In general.--Beginning in [fiscal year 2013]
fiscal year 2018, the Secretary shall assess and
collect fees in accordance with this section.
(2) Premarket application, premarket report,
supplement, and submission fee, and annual fee for
periodic reporting concerning a class iii device.--
(A) In general.--Except as provided in
subparagraph (B) and subsections [(d), (e), and
(f)] (d) and (e) each person who submits any of
the following, on or after [October 1, 2012]
October 1, 2017, shall be subject to a fee
established under subsection (c) for the fiscal
year involved in accordance with the following:
(i) A premarket application.
(ii) For a premarket report, a fee
equal to the fee that applies under
clause (i).
(iii) For a panel track supplement, a
fee equal to 75 percent of the fee that
applies under clause (i).
(iv) For a 180-day supplement, a fee
equal to 15 percent of the fee that
applies under clause (i).
(v) For a real-time supplement, a fee
equal to 7 percent of the fee that
applies under clause (i).
(vi) For a 30-day notice, a fee equal
to 1.6 percent of the fee that applies
under clause (i).
(vii) For an efficacy supplement, a
fee equal to the fee that applies under
clause (i).
(viii) For a premarket notification
submission, a fee equal to [2] 3.4
percent of the fee that applies under
clause (i).
(ix) For a request for classification
information, a fee equal to 1.35
percent of the fee that applies under
clause (i).
(x) For periodic reporting concerning
a class III device, an annual fee equal
to 3.5 percent of the fee that applies
under clause (i).
(xi) For a de novo classification
request, a fee equal to 30 percent of
the fee that applies under clause (i).
(B) Exceptions.--
(i) Humanitarian device exemption.--
An application under section 520(m) is
not subject to any fee under
subparagraph (A).
(ii) Further manufacturing use.--No
fee shall be required under
subparagraph (A) for the submission of
a premarket application under section
351 of the Public Health Service Act
for a product licensed for further
manufacturing use only.
(iii) State or federal government
sponsors.--No fee shall be required
under subparagraph (A) for a premarket
application, premarket report,
supplement, or premarket notification
submission submitted by a State or
Federal Government entity unless the
device involved is to be distributed
commercially.
(iv) Premarket notifications by third
parties.--No fee shall be required
under subparagraph (A) for a premarket
notification submission reviewed by an
accredited person pursuant to section
523.
(v) Pediatric conditions of use.--
(I) In general.--No fee shall
be required under subparagraph
(A) for a premarket
application, premarket report,
[or premarket notification
submission] premarket
notification submission, or de
novo classification request if
the proposed conditions of use
for the device involved are
solely for a pediatric
population. No fee shall be
required under such
subparagraph for a supplement
if the sole purpose of the
supplement is to propose
conditions of use for a
pediatric population.
(II) Subsequent proposal of
adult conditions of use.--In
the case of a person who
submits a premarket application
or premarket report for which,
under subclause (I), a fee
under subparagraph (A) is not
required, any supplement to
such application that proposes
conditions of use for any adult
population is subject to the
fee that applies under such
subparagraph for a premarket
application.
(C) Payment.--The fee required by
subparagraph (A) shall be due upon submission
of the premarket application, premarket report,
supplement, premarket notification submission,
30-day notice, request for classification
information, or periodic reporting concerning a
class III device. Applicants submitting
portions of applications pursuant to section
515(c)(4) shall pay such fees upon submission
of the first portion of such applications.
(D) Refunds.--
(i) Application refused for filing.--
The Secretary shall refund 75 percent
of the fee paid under subparagraph (A)
for any application, report, or
supplement that is refused for filing.
(ii) Application withdrawn before
filing.--The Secretary shall refund 75
percent of the fee paid under
subparagraph (A) for any application,
report, or supplement that is withdrawn
prior to the filing decision of the
Secretary.
(iii) Application withdrawn before
first action.--After receipt of a
request for a refund of the fee paid
under subparagraph (A) for a premarket
application, premarket report, or
supplement that is withdrawn after
filing but before a first action, the
Secretary may return some or all of the
fee. The amount of refund, if any,
shall be based on the level of effort
already expended on the review of such
application, report, or supplement.
(iv) Modular applications withdrawn
before first action.--The Secretary
shall refund 75 percent of the
application fee paid for an application
submitted under section 515(c)(4) that
is withdrawn before a second portion is
submitted and before a first action on
the first portion.
(v) Later withdrawn modular
applications.--If an application
submitted under section 515(c)(4) is
withdrawn after a second or subsequent
portion is submitted but before any
first action, the Secretary may return
a portion of the fee. The amount of
refund, if any, shall be based on the
level of effort already expended on the
review of the portions submitted.
(vi) Sole discretion to refund.--The
Secretary shall have sole discretion to
refund a fee or portion of the fee
under clause (iii) or (v). A
determination by the Secretary
concerning a refund under clause (iii)
or (v) shall not be reviewable.
(3) Annual establishment registration fee.--
(A) In general.--Except as provided in
subparagraph (B) [and subsection (f)], each
establishment subject to a registration fee
shall be subject to a fee for each initial or
annual registration under section 510 beginning
with its registration for fiscal year 2008.
(B) Exception.--No fee shall be required
under subparagraph (A) for an establishment
operated by a State or Federal governmental
entity or an Indian tribe (as defined in the
Indian Self Determination and Educational
Assistance Act), unless a device manufactured
by the establishment is to be distributed
commercially.
(C) Payment.--The fee required under
subparagraph (A) shall be due once each fiscal
year, upon the later of--
(i) the initial or annual
registration (as applicable) of the
establishment under section 510; or
(ii) the first business day after the
date of enactment of an appropriations
Act providing for the collection and
obligation of fees for such year under
this section.
[(b) Fee Amounts.--
[(1) In general.--Subject to subsections (c), (d),
(e), (f), and (i), for each of fiscal years 2013
through 2017, fees under subsection (a) shall be
derived from the base fee amounts specified in
paragraph (2), to generate the total revenue amounts
specified in paragraph (3).
[(2) Base fee amounts specified.--For purposes of
paragraph (1), the base fee amounts specified in this
paragraph are as follows:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
[Fee Type Year 2013 Year 2014 Year 2015 Year 2016 Year 2017
----------------------------------------------------------------------------------------------------------------
[Premarket Application................................... $248,000 $252,960 $258,019 $263,180 $268,443
Establishment Registration............................... $2,575 $3,200 $3,750 $3,872 $3,872
----------------------------------------------------------------------------------------------------------------
[(3) Total revenue amounts specified.--For purposes
of paragraph (1), the total revenue amounts specified
in this paragraph are as follows:
[(A) $97,722,301 for fiscal year 2013.
[(B) $112,580,497 for fiscal year 2014.
[(C) $125,767,107 for fiscal year 2015.
[(D) $129,339,949 for fiscal year 2016.
[(E) $130,184,348 for fiscal year 2017.]
(b) Fee Amounts.--
(1) In general.--Subject to subsections (c), (d),
(e), and (h), for each of fiscal years 2018 through
2022, fees under subsection (a) shall be derived from
the base fee amounts specified in paragraph (2), to
generate the total revenue amounts specified in
paragraph (3).
(2) Base fee amounts specified.--For purposes of
paragraph (1), the base fee amounts specified in this
paragraph are as follows:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
Fee Type Year 2018 Year 2019 Year 2020 Year 2021 Year 2022
----------------------------------------------------------------------------------------------------------------
Premarket Application.................................... $294,000 $300,000 $310,000 $328,000 $329,000
Establishment Registration............................... $4,375 $4,548 $4,760 $4,975 $4,978
----------------------------------------------------------------------------------------------------------------
(3) Total revenue amounts specified.--For purposes of
paragraph (1), the total revenue amounts specified in
this paragraph are as follows:
(A) $183,280,756 for fiscal year 2018.
(B) $190,654,875 for fiscal year 2019.
(C) $200,132,014 for fiscal year 2020.
(D) $211,748,789 for fiscal year 2021.
(E) $213,687,660 for fiscal year 2022.
(c) Annual Fee Setting; Adjustments.--
(1) In general.--The Secretary shall, 60 days before
the start of each fiscal year after September 30,
[2012] 2017, establish fees under subsection (a), based
on amounts specified under subsection (b) and the
adjustments provided under this subsection, and publish
such fees, and the rationale for any adjustments to
such fees, in the Federal Register.
(2) Inflation adjustments.--
(A) Adjustment to total revenue amounts.--For
fiscal year [2014] 2018 and each subsequent
fiscal year, the Secretary shall adjust the
total revenue amount specified in subsection
(b)(3) for such fiscal year by multiplying such
amount by the applicable inflation adjustment
under subparagraph (B) for such year.
[(B) Applicable inflation adjustment to total
revenue amounts.--The applicable inflation
adjustment for a fiscal year is--
[(i) for fiscal year 2014, the base
inflation adjustment under subparagraph
(C) for such fiscal year; and
[(ii) for fiscal year 2015 and each
subsequent fiscal year, the product
of--
[(I) the base inflation
adjustment under subparagraph
(C) for such fiscal year; and
[(II) the product of the base
inflation adjustment under
subparagraph (C) for each of
the fiscal years preceding such
fiscal year, beginning with
fiscal year 2014.]
(B) Applicable inflation adjustment.--The
applicable inflation adjustment for fiscal year
2018 and each subsequent fiscal year is the
product of--
(i) the base inflation adjustment
under subparagraph (C) for such fiscal
year; and
(ii) the product of the base
inflation adjustment under subparagraph
(C) for each of the fiscal years
preceding such fiscal year, beginning
with fiscal year 2016.
(C) Base inflation adjustment [to total
revenue amounts].--
(i) In general.--Subject to further
adjustment under clause (ii), the base
inflation adjustment for a fiscal year
is the sum of one plus--
(I) the average annual
percent change in the cost, per
full-time equivalent position
of the Food and Drug
Administration, of all
personnel compensation and
benefits paid with respect to
such positions for the first 3
years of the preceding 4 fiscal
years, multiplied by 0.60; and
(II) the average annual
percent change that occurred in
the Consumer Price Index for
urban consumers (Washington-
Baltimore, DC-MD-VA-WV; Not
Seasonally Adjusted; All items;
Annual Index) for the first 3
years of the preceding 4 years
of available data multiplied by
0.40.
(ii) Limitations.--For purposes of
subparagraph (B), if the base inflation
adjustment for a fiscal year under
clause (i)--
(I) is less than 1, such
adjustment shall be considered
to be equal to 1; or
(II) is greater than 1.04,
such adjustment shall be
considered to be equal to 1.04.
[(D) Adjustment to base fee amounts.--For
each of fiscal years 2014 through 2017, the
base fee amounts specified in subsection (b)(2)
shall be adjusted as needed, on a uniform
proportionate basis, to generate the total
revenue amounts under subsection (b)(3), as
adjusted for inflation under subparagraph (A).]
(D) Adjustment to base fee amounts.--For each
of fiscal years 2018 through 2022, the
Secretary shall--
(i) adjust the base fee amounts
specified in subsection (b)(2) for such
fiscal year by multiplying such amounts
by the applicable inflation adjustment
under subparagraph (B) for such year;
and
(ii) if the Secretary determines
necessary, increase (in addition to the
adjustment under clause (i)) such base
fee amounts, on a uniform proportionate
basis, to generate the total revenue
amounts under subsection (b)(3), as
adjusted for inflation under
subparagraph (A).
(3) Volume-based adjustments to establishment
registration base fees.--For each of fiscal years [2014
through 2017] 2018 through 2022, 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] increased, 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).
(4) Limit.--The total amount of fees charged, as
adjusted under this subsection, for a fiscal year may
not exceed the total costs for such fiscal year for the
resources allocated for the process for the review of
device applications.
(5) Supplement.--
(A) In general.--The Secretary may use
unobligated carryover balances from fees
collected in previous fiscal years to ensure
that sufficient fee revenues are available in
that fiscal year, so long as the Secretary
maintains unobligated carryover balances of not
less than 1 month of operating reserves for the
first month of the next fiscal year.
(B) Notice to congress.--Not later than 14
days before the Secretary anticipates the use
of funds described in subparagraph (A), the
Secretary shall provide notice to the Committee
on Health, Education, Labor, and Pensions and
the Committee on Appropriations of the Senate
and the Committee on Energy and Commerce and
the Committee on Appropriations of the House of
Representatives.
(d) Small Businesses; Fee Waiver and Fee Reduction Regarding
Premarket Approval Fees.--
(1) In general.--The Secretary shall grant a waiver
of the fee required under subsection (a) for one
premarket application, or one premarket report, where
the Secretary finds that the applicant involved is a
small business submitting its first premarket
application to the Secretary, or its first premarket
report, respectively, for review. For the purposes of
this paragraph, the term ``small business'' means an
entity that reported $30,000,000 or less of gross
receipts or sales in its most recent Federal income tax
return for a taxable year, including such returns of
all of its affiliates. In addition, for subsequent
premarket applications, premarket reports, and
supplements where the Secretary finds that the
applicant involved is a small business, the fees
[specified in clauses (i) through (v) and clauses
(vii), (ix), and (x)] specified in clauses (i) through
(vii) and clauses (ix), (x), and (xi) of subsection
(a)(2)(A) may be paid at a reduced rate in accordance
with paragraph (2)(C).
(2) Rules relating to premarket approval fees.--
(A) Definition.--For purposes of this
paragraph, the term ``small business'' means an
entity that reported $100,000,000 or less of
gross receipts or sales in its most recent
Federal income tax return for a taxable year,
including such returns of all of its
affiliates.
(B) Evidence of qualification.--
(i) In general.--An applicant shall
pay the higher fees established by the
Secretary each year unless the
applicant submits evidence that it
qualifies for a waiver of the fee or
the lower fee rate.
(ii) Firms submitting tax returns to
the united states internal revenue
service.--The applicant shall support
its claim that it meets the definition
under subparagraph (A) by submission of
a copy of its most recent Federal
income tax return for a taxable year,
and a copy of such returns of its
affiliates, which show an amount of
gross sales or receipts that is less
than the maximum established in
subparagraph (A). The applicant, and
each of such affiliates, shall certify
that the information provided is a true
and accurate copy of the actual tax
forms they submitted to the Internal
Revenue Service. If no tax forms are
submitted for any affiliate, the
applicant shall certify that the
applicant has no affiliates.
(iii) Firms not submitting tax
returns to the united states internal
revenue service.--In the case of an
applicant that has not previously
submitted a Federal income tax return,
the applicant and each of its
affiliates shall demonstrate that it
meets the definition under subparagraph
(A) by submission of a signed
certification, in such form as the
Secretary may direct through a notice
published in the Federal Register, that
the applicant or affiliate meets the
criteria for a small business and a
certification, in English, from the
national taxing authority of the
country in which the applicant or, if
applicable, affiliate is headquartered.
The certification from such taxing
authority shall bear the official seal
of such taxing authority and shall
provide the applicant's or affiliate's
gross receipts or sales for the most
recent year in both the local currency
of such country and in United States
dollars, the exchange rate used in
converting such local currency to
dollars, and the dates during which
these receipts or sales were collected.
The applicant shall also submit a
statement signed by the head of the
applicant's firm or by its chief
financial officer that the applicant
has submitted certifications for all of
its affiliates, or that the applicant
has no affiliates.
(C) Reduced fees.--Where the Secretary finds
that the applicant involved meets the
definition under subparagraph (A), the fees
established under subsection (c)(1) may be paid
at a reduced rate of--
(i) 25 percent of the fee established
under such subsection for a premarket
application, a premarket report, a
[supplement, or] supplement, periodic
reporting concerning a class III
device, or a de novo classification
request; and
(ii) 50 percent of the fee
established under such subsection for a
30-day notice or a request for
classification information.
(D) Request for fee waiver or reduction.--An
applicant seeking a fee waiver or reduction
under this subsection shall submit supporting
information to the Secretary at least 60 days
before the fee is required pursuant to
subsection (a). The decision of the Secretary
regarding whether an entity qualifies for such
a waiver or reduction is not reviewable.
(e) Small Businesses; Fee Reduction Regarding Premarket
Notification Submissions.--
(1) In general.--For fiscal year 2008 and each
subsequent fiscal year, where the Secretary finds that
the applicant involved is a small business, the fee
specified in subsection (a)(2)(A)(viii) may be paid at
a reduced rate in accordance with paragraph (2)(C).
(2) Rules relating to premarket notification
submissions.--
(A) Definition.--For purposes of this
subsection, the term ``small business'' means
an entity that reported $100,000,000 or less of
gross receipts or sales in its most recent
Federal income tax return for a taxable year,
including such returns of all of its
affiliates.
(B) Evidence of qualification.--
(i) In general.--An applicant shall
pay the higher fees established by the
Secretary each year unless the
applicant submits evidence that it
qualifies for the lower fee rate.
(ii) Firms submitting tax returns to
the united states internal revenue
service.--The applicant shall support
its claim that it meets the definition
under subparagraph (A) by submission of
a copy of its most recent Federal
income tax return for a taxable year,
and a copy of such returns of its
affiliates, which show an amount of
gross sales or receipts that is less
than the maximum established in
subparagraph (A). The applicant, and
each of such affiliates, shall certify
that the information provided is a true
and accurate copy of the actual tax
forms they submitted to the Internal
Revenue Service. If no tax forms are
submitted for any affiliate, the
applicant shall certify that the
applicant has no affiliates.
(iii) Firms not submitting tax
returns to the united states internal
revenue service.--In the case of an
applicant that has not previously
submitted a Federal income tax return,
the applicant and each of its
affiliates shall demonstrate that it
meets the definition under subparagraph
(A) by submission of a signed
certification, in such form as the
Secretary may direct through a notice
published in the Federal Register, that
the applicant or affiliate meets the
criteria for a small business and a
certification, in English, from the
national taxing authority of the
country in which the applicant or, if
applicable, affiliate is headquartered.
The certification from such taxing
authority shall bear the official seal
of such taxing authority and shall
provide the applicant's or affiliate's
gross receipts or sales for the most
recent year in both the local currency
of such country and in United States
dollars, the exchange rate used in
converting such local currency to
dollars, and the dates during which
these receipts or sales were collected.
The applicant shall also submit a
statement signed by the head of the
applicant's firm or by its chief
financial officer that the applicant
has submitted certifications for all of
its affiliates, or that the applicant
has no affiliates.
(C) Reduced fees.--For fiscal year 2008 and
each subsequent fiscal year, where the
Secretary finds that the applicant involved
meets the definition under subparagraph (A),
the fee for a premarket notification submission
may be paid at [50] 25 percent of the fee that
applies under subsection (a)(2)(A)(viii), and
as established under subsection (c)(1).
(D) Request for reduction.--An applicant
seeking a fee reduction under this subsection
shall submit supporting information to the
Secretary at least 60 days before the fee is
required pursuant to subsection (a). The
decision of the Secretary regarding whether an
entity qualifies for such a reduction is not
reviewable.
[(f) Fee Waiver or Reduction.--
[(1) In general.--The Secretary may, at the
Secretary's sole discretion, grant a waiver or
reduction of fees under subsection (a)(2) or (a)(3) if
the Secretary finds that such waiver or reduction is in
the interest of public health.
[(2) Limitation.--The sum of all fee waivers or
reductions granted by the Secretary in any fiscal year
under paragraph (1) shall not exceed 2 percent of the
total fee revenue amounts established for such year
under subsection (c).
[(3) Duration.--The authority provided by this
subsection terminates October 1, 2017.]
[(g)] (f) Effect of Failure To Pay Fees.--
(1) No acceptance of submissions.--A premarket
application, premarket report, supplement, premarket
notification submission, 30-day notice, request for
classification information, [or periodic reporting
concerning a class III device] periodic reporting
concerning a class III device, or de novo
classification request submitted by a person subject to
fees under subsections (a)(2) and (a)(3) shall be
considered incomplete and shall not be accepted by the
Secretary until [all fees] all such fees owed by such
person have been paid.
(2) No registration.--Registration information
submitted under section 510 by an establishment subject
to a registration fee shall be considered incomplete
and shall not be accepted by the Secretary until the
registration fee under subsection (a)(3) owed for the
establishment has been paid. Until the fee is paid and
the registration is complete, the establishment is
deemed to have failed to register in accordance with
section 510.
[(h)] (g) Conditions.--
(1) Performance goals; termination of program.--With
respect to the amount that, under the salaries and
expenses account of the Food and Drug Administration,
is appropriated for a fiscal year for devices and
radiological products, fees may not be assessed under
subsection (a) for the fiscal year, and the Secretary
is not expected to meet any performance goals
identified for the fiscal year, if--
(A) the amount so appropriated for the fiscal
year, excluding the amount of fees appropriated
for the fiscal year, is more than 1 percent
less than [$280,587,000] $320,825,000
multiplied by the adjustment factor applicable
to such fiscal year; or
(B) fees were not assessed under subsection
(a) for the previous fiscal year.
(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal
year because of paragraph (1) 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 premarket
applications, supplements, premarket reports, premarket
notification submissions, 30-day notices, requests for
classification information, periodic reporting
concerning a class III device, and establishment
registrations at any time in such fiscal year,
notwithstanding the provisions of subsection (a)
relating to the date fees are to be paid.
[(i)] (h) Crediting and Availability of Fees.--
(1) In general.--Subject to paragraph (2)(C), fees
authorized under subsection (a) shall be collected and
available for obligation only to the extent and in the
amount provided in advance in appropriation Acts. Such
fees are authorized to be appropriated 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
device applications.
(2) Collections and appropriation acts.--
(A) In general.--The fees authorized by this
section--
(i) subject to subparagraph (C),
shall be collected and available in
each fiscal year in an amount not to
exceed the amount specified in
appropriation Acts, or otherwise made
available for obligation, for such
fiscal year, and
(ii) shall be available to defray
increases in the costs of the resources
allocated for the process for the
review of device applications
(including increases in 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) over such
costs, excluding costs paid from fees
collected under this section, for
fiscal year 2009 multiplied by the
adjustment factor.
(B) Compliance.--
(i) In general.--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 the
process for the review of device
applications--
(I) are not more than 3 percent below
the level specified in subparagraph
(A)(ii); or
(II)(aa) are more than 3 percent
below the level specified in
subparagraph (A)(ii), and fees assessed
for a subsequent fiscal year are
decreased by the amount in excess of 3
percent by which such costs fell below
the level specified in such
subparagraph; and
(bb) such costs are not more than 5
percent below the level specified in
such subparagraph.
(ii) More than 5 percent.--To the
extent such costs are more than 5
percent below the specified level in
subparagraph (A)(ii), fees may not be
collected under this section for that
fiscal year.
(C) Provision for early payments.--Payment of
fees authorized under this section for a fiscal
year, prior to the due date for such fees, may
be accepted by the Secretary in accordance with
authority provided in advance in a prior year
appropriations Act.
(3) Authorizations of appropriations.--For each of
the fiscal years [2013 through 2017] 2018 through 2022,
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).] subsection (c).
[(4) Offset.--If the cumulative amount of fees
collected during fiscal years 2013, 2014, and 2015,
added to the amount estimated to be collected for
fiscal year 2016, which estimate shall be based upon
the amount of fees received by the Secretary through
June 30, 2016, exceeds the cumulative amount
appropriated pursuant to paragraph (3) for these four
fiscal years, the excess shall be credited to the
appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall
be subtracted from the amount of fees that would
otherwise be authorized to be collected under this
section pursuant to appropriation Acts for fiscal year
2017.]
[(j)] (i) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States Code.
[(k)] (j) Written Requests for Refunds.--To qualify for
consideration for a refund under subsection (a)(2)(D), a person
shall submit to the Secretary a written request for such refund
not later than 180 days after such fee is due.
[(l)] (k) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in the process
of the review of device applications, be reduced to offset the
number of officers, employees, and advisory committees so
engaged.
SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Reports.--
(1) Performance report.--
(A) In general.--Beginning with fiscal year
[2013] 2018, for each fiscal year for which
fees are collected under this part, the
Secretary shall prepare and submit to the
Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on
Energy and Commerce of the House of
Representatives annual reports concerning the
progress of the Food and Drug Administration in
achieving the goals identified in the letters
described in section 201(b) of [the Medical
Device User Fee Amendments of 2012] the Medical
Device User Fee Amendments of 2017 during such
fiscal year and the future plans of the Food
and Drug Administration for meeting the goals.
(B) Publication.--With regard to information
to be reported by the Food and Drug
Administration to industry on a quarterly and
annual basis pursuant to the letters described
in section 201(b) of [the Medical Device User
Fee Amendments Act of 2012] the Medical Device
User Fee Amendments of 2017, the Secretary
shall make such information publicly available
on the Internet Web site of the Food and Drug
Administration not later than 60 days after the
end of each quarter or 120 days after the end
of each fiscal year, respectively, to which
such information applies. This information
shall include the status of the independent
assessment identified in the letters described
in such section 201(b).
(C) Updates.--The Secretary shall include in
each report under subparagraph (A) information
on all previous cohorts for which the Secretary
has not given a complete response on all device
premarket applications and reports,
supplements, and premarket notifications in the
cohort.
(2) Fiscal report.--For fiscal years [2013 through
2017] 2018 through 2022, not later than 120 days after
the end of each fiscal year during 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, 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 during
such fiscal year for which the report is made.
(3) Public availability.--The Secretary shall make
the reports required under paragraphs (1) and (2)
available to the public on the Internet Web site of the
Food and Drug Administration.
(b) Reauthorization.--
(1) Consultation.--In developing recommendations to
present to Congress with respect to the goals, and
plans for meeting the goals, for the process for the
review of device applications for the first 5 fiscal
years after fiscal year [2017] 2022, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
(A) the Committee on Energy and Commerce of
the House of Representatives;
(B) the Committee on Health, Education,
Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer
advocacy groups; and
(F) the regulated industry.
(2) Prior public input.--Prior to beginning
negotiations with the regulated industry on the
reauthorization of this part, the Secretary shall--
(A) publish a notice in the Federal Register
requesting public input on the reauthorization;
(B) hold a public meeting at which the public
may present its views on the reauthorization,
including specific suggestions for changes to
the goals referred to in subsection (a)(1);
(C) provide a period of 30 days after the
public meeting to obtain written comments from
the public suggesting changes to this part; and
(D) publish the comments on the Food and Drug
Administration's Internet Web site.
(3) Periodic consultation.--Not less frequently than
once every month during negotiations with the regulated
industry, the Secretary shall hold discussions with
representatives of patient and consumer advocacy groups
to continue discussions of their views on the
reauthorization and their suggestions for changes to
this part as expressed under paragraph (2).
(4) Public review of recommendations.--After
negotiations with the regulated industry, the Secretary
shall--
(A) present the recommendations developed
under paragraph (1) to the Congressional
committees specified in such paragraph;
(B) publish such recommendations in the
Federal Register;
(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
(D) hold a meeting at which the public may
present its views on such recommendations; and
(E) after consideration of such public views
and comments, revise such recommendations as
necessary.
(5) Transmittal of recommendations.--Not later than
January 15, [2017] 2022, the Secretary shall transmit
to Congress the revised recommendations under paragraph
(4), a summary of the views and comments received under
such paragraph, and any changes made to the
recommendations in response to such views and comments.
(6) Minutes of negotiation meetings.--
(A) Public availability.--Before presenting
the recommendations developed under paragraphs
(1) through (5) to the Congress, the Secretary
shall make publicly available, on the public
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 regulated industry.
(B) Content.--The minutes described under
subparagraph (A) shall summarize any
substantive proposal made by any party to the
negotiations as well as significant
controversies or differences of opinion during
the negotiations and their resolution.
PART 4--FEES RELATING TO ANIMAL DRUGS
* * * * * * *
SEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
(a) Types of Fees.--Beginning in fiscal year 2004, the
Secretary shall assess and collect fees in accordance with this
section as follows:
(1) Animal drug application and supplement fee.--
(A) In general.--Each person that submits, on
or after September 1, 2003, an animal drug
application or a supplemental animal drug
application shall be subject to a fee as
follows:
(i) A fee established in subsection
(c) for an animal drug application,
except an animal drug application
subject to the criteria set forth in
section 512(d)(4).
(ii) A fee established in subsection
(c), in an amount that is equal to 50
percent of the amount of the fee under
clause (i), for--
(I) a supplemental animal
drug application for which
safety or effectiveness data
are required; and
(II) an animal drug
application subject to the
criteria set forth in section
512(d)(4).
(B) Payment.--The fee required by
subparagraph (A) shall be due upon submission
of the animal drug application or supplemental
animal drug application.
(C) Exception for previously filed
application or supplement.--If an animal drug
application or a supplemental animal drug
application 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 or refund), the
submission of an animal drug application or a
supplemental animal drug application 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).
(D) Refund of fee if application refused for
filing.--The Secretary shall refund 75 percent
of the fee paid under subparagraph (B) for any
animal drug application or supplemental animal
drug application which is refused for filing.
(E) Refund of fee if application withdrawn.--
If an animal drug application or a supplemental
animal drug application is withdrawn after the
application or supplement was filed, the
Secretary may refund the fee or portion of the
fee paid under subparagraph (B) if no
substantial work was performed on the
application or supplement after the application
or supplement was filed. The Secretary shall
have the sole discretion to refund the fee
under this paragraph. A determination by the
Secretary concerning a refund under this
paragraph shall not be reviewable.
(2) Animal drug product fee.--
(A) In general.--Each person--
(i) who is named as the applicant in
an animal drug application or
supplemental animal drug application
for an animal drug product which has
been submitted for listing under
section 510; and
(ii) who, after September 1, 2003,
had pending before the Secretary an
animal drug application or supplemental
animal drug application,
shall pay for each such animal drug product the
annual fee established in subsection (c).
(B) Payment; fee due date.--Such fee shall be
payable for the fiscal year in which the animal
drug product is first submitted for listing
under section 510, or is submitted for
relisting under section 510 if the animal drug
product has been withdrawn from listing and
relisted. After such fee is paid for that
fiscal year, such fee shall be due each
subsequent fiscal year that the product remains
listed, upon the later of--
(i) the first business day after the
date of enactment of an appropriations
Act providing for the collection and
obligation of fees for such fiscal year
under this section; or
(ii) January 31 of each year.
(C) Limitation.--Such fee shall be paid only
once for each animal drug product for a fiscal
year in which the fee is payable.
(3) Animal drug establishment fee.--
(A) In general.--Each person--
(i) who owns or operates, directly or
through an affiliate, an animal drug
establishment;
(ii) who is named as the applicant in
an animal drug application or
supplemental animal drug application
for an animal drug product which has
been submitted for listing under
section 510; and
(iii) who, after September 1, 2003,
had pending before the Secretary an
animal drug application or supplemental
animal drug application,
shall be assessed an annual establishment fee
as established in subsection (c) for each
animal drug establishment listed in its
approved animal drug application as an
establishment that manufactures the animal drug
product named in the application.
(B) Payment; fee due date.--The annual
establishment fee shall be assessed in each
fiscal year in which the animal drug product
named in the application is assessed a fee
under paragraph (2) unless the animal drug
establishment listed in the application does
not engage in the manufacture of the animal
drug product during the fiscal year. The fee
under this paragraph for a fiscal year shall be
due upon the later of--
(i) the first business day after the
date of enactment of an appropriations
Act providing for the collection and
obligation of fees for such fiscal year
under this section; or
(ii) January 31 of each year.
[(C) Limitation.--
[(i) In general.--An establishment
shall be assessed only one fee per
fiscal year under this section, subject
to clause (ii).
[(ii) Certain manufacturers.--If a
single establishment manufactures both
animal drug products and prescription
drug products, as defined in section
735(3), such establishment shall be
assessed both the animal drug
establishment fee and the prescription
drug establishment fee, as set forth in
section 736(a)(2), within a single
fiscal year.]
(C) Limitation.--An establishment shall be
assessed only one fee per fiscal year under
this section.
(4) Animal drug sponsor fee.--
(A) In general.--Each person--
(i) who meets the definition of an
animal drug sponsor within a fiscal
year; and
(ii) who, after September 1, 2003,
had pending before the Secretary an
animal drug application, a supplemental
animal drug application, or an
investigational animal drug submission,
shall be assessed an annual sponsor fee as
established under subsection (c).
(B) Payment; fee due date.--The fee under
this paragraph for a fiscal year shall be due
upon the later of--
(i) the first business day after the
date of enactment of an appropriations
Act providing for the collection and
obligation of fees for such fiscal year
under this section; or
(ii) January 31 of each year.
(C) Limitation.--Each animal drug sponsor
shall pay only one such fee each fiscal year.
(b) Fee Revenue Amounts.--
(1) In general.--Subject to subsections (c), (d),
(f), and (g)--
(A) for fiscal year 2014, the fees required
under subsection (a) shall be established to
generate a total revenue amount of $23,600,000;
and
(B) for each of fiscal years 2015 through
2018, the fees required under subsection (a)
shall be established to generate a total
revenue amount of $21,600,000.
(2) Types of fees.--Of the total revenue amount
determined for a fiscal year under paragraph (1)--
(A) 20 percent shall be derived from fees
under subsection (a)(1) (relating to animal
drug applications and supplements);
(B) 27 percent shall be derived from fees
under subsection (a)(2) (relating to animal
drug products);
(C) 26 percent shall be derived from fees
under subsection (a)(3) (relating to animal
drug establishments); and
(D) 27 percent shall be derived from fees
under subsection (a)(4) (relating to animal
drug sponsors).
(c) Annual Fee Setting; Adjustments.--
(1) Annual fee setting.--The Secretary shall
establish, 60 days before the start of each fiscal year
beginning after September 30, 2003, for that fiscal
year, animal drug application fees, supplemental animal
drug application fees, animal drug sponsor fees, animal
drug establishment fees, and animal drug product fees
based on the revenue amounts established under
subsection (b) and the adjustments provided under this
subsection.
(2) Inflation adjustment.--For fiscal year 2015 and
subsequent fiscal years, the revenue amounts
established in subsection (b) shall be adjusted by the
Secretary by notice, published in the Federal Register,
for a fiscal year, by an amount equal to the sum of--
(A) one;
(B) the average annual percent change in the
cost, per full-time equivalent position of the
Food and Drug Administration, of all personnel
compensation and benefits paid with respect to
such positions for the first 3 of the preceding
4 fiscal years for which data are available,
multiplied by the average proportion of
personnel compensation and benefits costs to
total Food and Drug Administration costs for
the first 3 years of the preceding 4 fiscal
years for which data are available; and
(C) the average annual percent change that
occurred in the Consumer Price Index for urban
consumers (Washington-Baltimore, DC-MD-VA-WV;
not seasonally adjusted; all items less food
and energy; annual index) for the first 3 years
of the preceding 4 years for which data are
available multiplied by the average proportion
of all costs other than personnel compensation
and benefits costs to total Food and Drug
Administration costs for the first 3 years of
the preceding 4 fiscal years for which data are
available.
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 2014 under this paragraph.
(3) Workload adjustment.--For fiscal year 2015 and
subsequent fiscal years, after the revenue amounts
established in subsection (b) are adjusted for
inflation in accordance with paragraph (2), the revenue
amounts shall be further adjusted for such fiscal year
to reflect changes in the workload of the Secretary for
the process for the review of animal drug applications.
With respect to such adjustment--
(A) such adjustment shall be determined by
the Secretary based on a weighted average of
the change in the total number of animal drug
applications, supplemental animal drug
applications for which data with respect to
safety or effectiveness are required,
manufacturing supplemental animal drug
applications, investigational animal drug study
submissions, and investigational animal drug
protocol submissions submitted to the
Secretary;
(B) the Secretary shall publish in the
Federal Register the fees resulting from such
adjustment and the supporting methodologies;
and
(C) under no circumstances shall such
adjustment result in fee revenues for a fiscal
year that are less than the fee revenues for
that fiscal year established in subsection (b),
as adjusted for inflation under paragraph (2).
(4) Final year adjustment.--For fiscal year 2018, the
Secretary may, in addition to other adjustments under
this subsection, further increase the fees under this
section, if such an adjustment is necessary, to provide
for up to 3 months of operating reserves of carryover
user fees for the process for the review of animal drug
applications for the first 3 months of fiscal year
2019. If the Food and Drug Administration has carryover
balances for the process for the review of animal drug
applications in excess of 3 months of such operating
reserves, then this adjustment will not be made. If
this adjustment is necessary, then the rationale for
the amount of the increase shall be contained in the
annual notice setting fees for fiscal year 2018.
(5) Limit.--The total amount of fees charged, as
adjusted under this subsection, for a fiscal year may
not exceed the total costs for such fiscal year for the
resources allocated for the process for the review of
animal drug applications.
(d) Fee Waiver or Reduction.--
(1) In general.--The Secretary shall grant a waiver
from or a reduction of one or more fees assessed under
subsection (a) where the Secretary finds that--
(A) the assessment of the fee would present a
significant barrier to innovation because of
limited resources available to such person or
other circumstances;
(B) the fees to be paid by such person will
exceed the anticipated present and future costs
incurred by the Secretary in conducting the
process for the review of animal drug
applications for such person;
(C) the animal drug application or
supplemental animal drug application is
intended solely to provide for use of the
animal drug in--
(i) a Type B medicated feed (as
defined in section 558.3(b)(3) of title
21, Code of Federal Regulations (or any
successor regulation)) intended for use
in the manufacture of Type C free-
choice medicated feeds; or
(ii) a Type C free-choice medicated
feed (as defined in section 558.3(b)(4)
of title 21, Code of Federal
Regulations (or any successor
regulation));
(D) the animal drug application or
supplemental animal drug application is
intended solely to provide for a minor use or
minor species indication; or
(E) the sponsor involved is a small business
submitting its first animal drug application to
the Secretary for review.
(2) Use of standard costs.--In making the finding in
paragraph (1)(B), the Secretary may use standard costs.
(3) Rules for small businesses.--
(A) Definition.--In paragraph (1)(E), the
term ``small business'' means an entity that
has fewer than 500 employees, including
employees of affiliates.
(B) Waiver of application fee.--The Secretary
shall waive under paragraph (1)(E) the
application fee for the first animal drug
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 application fees for
all subsequent animal drug applications and
supplemental animal drug applications for which
safety or effectiveness data are required in
the same manner as an entity that does not
qualify as a small business.
(C) Certification.--The Secretary shall
require any person who applies for a waiver
under paragraph (1)(E) to certify their
qualification for the waiver. The Secretary
shall periodically publish in the Federal
Register a list of persons making such
certifications.
(e) Effect of Failure To Pay Fees.--An animal drug
application or supplemental animal drug application 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. An investigational animal drug submission under section
739(5)(B) that is submitted by a person subject to fees under
subsection (a) shall be considered incomplete and shall not be
accepted for review by the Secretary until all fees owed by
such person have been paid. The Secretary may discontinue
review of any animal drug application, supplemental animal drug
application or investigational animal drug submission from a
person if such person has not submitted for payment all fees
owed under this section by 30 days after the date upon which
they are due.
(f) Assessment of Fees.--
(1) Limitation.--Fees may not be assessed under
subsection (a) for a fiscal year beginning after fiscal
year 2003 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 the fiscal year
2003 (excluding the amount of fees appropriated for
such fiscal year) multiplied by the adjustment factor
applicable to the fiscal year involved.
(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal
year because of paragraph (1) 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 animal drug
applications, supplemental animal drug applications,
investigational animal drug submissions, animal drug
sponsors, animal drug establishments and animal drug
products at any time in such fiscal year
notwithstanding the provisions of subsection (a)
relating to the date fees are to be paid.
(g) Crediting and Availability of Fees.--
(1) In general.--Subject to paragraph (2)(C), 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 be appropriated 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 salary and expenses with such
fiscal year limitation. The sums transferred shall be
available solely for the process for the review of
animal drug applications.
(2) Collections and appropriation acts.--
(A) In general.--The fees authorized by this
section--
(i) subject to subparagraph (C),
shall be collected and available in
each fiscal year in an amount not to
exceed the amount specified in
appropriation Acts, or otherwise made
available for obligation for such
fiscal year, and
(ii) shall be available to defray
increases in the costs of the resources
allocated for the process for the
review of animal drug applications
(including increases in 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) over such
costs, excluding costs paid from fees
collected under this section, for
fiscal year 2003 multiplied by the
adjustment factor.
(B) Compliance.--The Secretary shall be
considered to have met the requirements of
subparagraph (A)(ii) in any fiscal year if the
costs funded by appropriations and allocated
for the process for the review of animal drug
applications--
(i) are not more than 3 percent below
the level specified in subparagraph
(A)(ii); or
(ii)(I) are more than 3 percent below
the level specified in subparagraph
(A)(ii), and fees assessed for the
fiscal year following the subsequent
fiscal year are decreased by the amount
in excess of 3 percent by which such
costs fell below the level specified in
subparagraph (A)(ii); and
(II) such costs are not more than 5
percent below the level specified in
subparagraph (A)(ii).
(C) Provision for early payments.--Payment of
fees authorized under this section for a fiscal
year, prior to the due date for such fees, may
be accepted by the Secretary in accordance with
authority provided in advance in a prior year
appropriations Act.
(3) Authorization of appropriations.--For each of the
fiscal years 2014 through 2018, there is authorized to
be appropriated for fees under this section an amount
equal to the total revenue amount determined under
subsection (b) for the fiscal year, as adjusted or
otherwise affected under subsection (c) and paragraph
(4).
(4) Offset of overcollections; recovery of collection
shortfalls.--
(A) Offset of overcollections.--If the sum of
the cumulative amount of fees collected under
this section for fiscal years 2014 through 2016
and the amount of fees estimated to be
collected under this section for fiscal year
2017 (including any increased fee collections
attributable to subparagraph (B)), exceeds the
cumulative amount appropriated pursuant to
paragraph (3) for the fiscal years 2014 through
2017, the excess amount shall be credited to
the appropriation account of the Food and Drug
Administration as provided in paragraph (1),
and shall be subtracted from the amount of fees
that would otherwise be authorized to be
collected under this section pursuant to
appropriation Acts for fiscal year 2018.
(B) Recovery of collection shortfalls.--
(i) Fiscal year 2016.--For fiscal
year 2016, the amount of fees otherwise
authorized to be collected under this
section shall be increased by the
amount, if any, by which the amount
collected under this section and
appropriated for fiscal year 2014 falls
below the amount of fees authorized for
fiscal year 2014 under paragraph (3).
(ii) Fiscal year 2017.--For fiscal
year 2017, the amount of fees otherwise
authorized to be collected under this
section shall be increased by the
amount, if any, by which the amount
collected under this section and
appropriated for fiscal year 2015 falls
below the amount of fees authorized for
fiscal year 2015 under paragraph (3).
(iii) Fiscal year 2018.--For fiscal
year 2018, the amount of fees otherwise
authorized to be collected under this
section (including any reduction in the
authorized amount under subparagraph
(A)), shall be increased by the
cumulative amount, if any, by which the
amount collected under this section and
appropriated for fiscal years 2016 and
2017 (including estimated collections
for fiscal year 2017) falls below the
cumulative amount of fees authorized
under paragraph (3) for fiscal years
2016 and 2017.
(h) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States Code.
(i) Written Requests for Waivers, Reductions, and Refunds.--
To qualify for consideration for a waiver or reduction under
subsection (d), or for a refund of any fee collected in
accordance with subsection (a), a person shall submit to the
Secretary a written request for such waiver, reduction, or
refund not later than 180 days after such fee is due.
(j) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in the process
of the review of animal drug applications, be reduced to offset
the number of officers, employees, and advisory committees so
engaged.
(k) Abbreviated New Animal Drug Applications.--The Secretary
shall--
(1) to the extent practicable, segregate the review
of abbreviated new animal drug applications from the
process for the review of animal drug applications; and
(2) adopt other administrative procedures to ensure
that review times of abbreviated new animal drug
applications do not increase from their current level
due to activities under the user fee program.
* * * * * * *
PART 7--FEES RELATING TO GENERIC DRUGS
SEC. 744A. DEFINITIONS.
For purposes of this part:
(1) The term ``abbreviated new drug application''--
(A) means an application submitted under
section 505(j), an abbreviated application
submitted under section 507 (as in effect on
the day before the date of enactment of the
Food and Drug Administration Modernization Act
of 1997), or an abbreviated new drug
application submitted pursuant to regulations
in effect prior to the implementation of the
Drug Price Competition and Patent Term
Restoration Act of 1984; and
(B) does not include an [application for a
positron emission tomography drug.]
application--
(i) for a positron emission
tomography drug; or
(ii) submitted by a State or Federal
governmental entity for a drug that is
not distributed commercially.
(2) The term ``active pharmaceutical ingredient''
means--
(A) a substance, or a mixture when the
substance is unstable or cannot be transported
on its own, intended--
(i) to be used as a component of a
drug; and
(ii) to furnish pharmacological
activity or other direct effect in the
diagnosis, cure, mitigation, treatment,
or prevention of disease, or to affect
the structure or any function of the
human body; or
(B) a substance intended for final
crystallization, purification, or salt
formation, or any combination of those
activities, to become a substance or mixture
described in subparagraph (A).
(3) The term ``adjustment factor'' means a factor
applicable to a fiscal year that is the Consumer Price
Index for all urban consumers (all items; United States
city average) for October of the preceding fiscal year
divided by such Index for October 2011.
(4) The term ``affiliate'' means a business entity
that has a relationship with a second business entity
if, directly or indirectly--
(A) one business entity controls, or has the
power to control, the other business entity; or
(B) a third party controls, or has power to
control, both of the business entities.
(5) The term ``contract manufacturing organization
facility'' means a manufacturing facility of a finished
dosage form of a drug approved pursuant to an
abbreviated new drug application, where such
manufacturing facility is not identified in an approved
abbreviated new drug application held by the owner of
such facility or an affiliate of such owner or
facility.
[(5)] (6)(A) The term ``facility''--
(i) means a business or other entity--
(I) under one management, either
direct or indirect; and
(II) at one geographic location or
address engaged in manufacturing or
processing an active pharmaceutical
ingredient or a finished dosage form;
and
(ii) does not include a business or other
entity whose only manufacturing or processing
activities are one or more of the following:
repackaging, relabeling, or testing.
(B) For purposes of subparagraph (A), separate
buildings within close proximity are considered to be
at one geographic location or address if the activities
in them are--
(i) closely related to the same business
enterprise;
(ii) under the supervision of the same local
management; and
(iii) capable of being inspected by the Food
and Drug Administration during a single
inspection.
(C) If a business or other entity would meet the
definition of a facility under this paragraph but for
being under multiple management, the business or other
entity is deemed to constitute multiple facilities, one
per management entity, for purposes of this paragraph.
[(6)] (7) The term ``finished dosage form'' means--
(A) a drug product in the form in which it
will be administered to a patient, such as a
tablet, capsule, solution, or topical
application;
(B) a drug product in a form in which
reconstitution is necessary prior to
administration to a patient, such as oral
suspensions or lyophilized powders; or
(C) any combination of an active
pharmaceutical ingredient with another
component of a drug product for purposes of
production of a drug product described in
subparagraph (A) or (B).
[(7)] (8) The term ``generic drug submission'' means
an abbreviated new drug application, an amendment to an
abbreviated new drug application, or a prior approval
supplement to an abbreviated new drug application.
[(8)] (9) The term ``human generic drug activities''
means the following activities of the Secretary
associated with generic drugs and inspection of
facilities associated with generic drugs:
(A) The activities necessary for the review
of generic drug submissions, including review
of drug master files referenced in such
submissions.
(B) The issuance of--
(i) approval letters which approve
abbreviated new drug applications or
supplements to such applications; or
(ii) complete response letters which
set forth in detail the specific
deficiencies in such applications and,
where appropriate, the actions
necessary to place such applications in
condition for approval.
(C) The issuance of letters related to Type
II active pharmaceutical drug master files
which--
(i) set forth in detail the specific
deficiencies in such submissions, and
where appropriate, the actions
necessary to resolve those
deficiencies; or
(ii) document that no deficiencies
need to be addressed.
(D) Inspections related to generic drugs.
(E) Monitoring of research conducted in
connection with the review of generic drug
submissions and drug master files.
(F) Postmarket safety activities with respect
to drugs approved under abbreviated new drug
applications or supplements, including the
following activities:
(i) Collecting, developing, and
reviewing safety information on
approved drugs, including adverse event
reports.
(ii) Developing and using improved
adverse-event data-collection systems,
including information technology
systems.
(iii) Developing and using improved
analytical tools to assess potential
safety problems, including access to
external data bases.
(iv) Implementing and enforcing
section 505(o) (relating to
postapproval studies and clinical
trials and labeling changes) and
section 505(p) (relating to risk
evaluation and mitigation strategies)
insofar as those activities relate to
abbreviated new drug applications.
(v) Carrying out section 505(k)(5)
(relating to adverse-event reports and
postmarket safety activities).
(G) Regulatory science activities related to
generic drugs.
[(9)] (10) The term ``positron emission tomography
drug'' has the meaning given to the term ``compounded
positron emission tomography drug'' in section 201(ii),
except that paragraph (1)(B) of such section shall not
apply.
[(10)] (11) The term ``prior approval supplement''
means a request to the Secretary to approve a change in
the drug substance, drug product, production process,
quality controls, equipment, or facilities covered by
an approved abbreviated new drug application when that
change has a substantial potential to have an adverse
effect on the identity, strength, quality, purity, or
potency of the drug product as these factors may relate
to the safety or effectiveness of the drug product.
[(11)] (12) The term ``resources allocated for human
generic drug activities'' means the expenses for--
(A) officers and employees of the Food and
Drug Administration, contractors of the Food
and Drug Administration, advisory committees,
and costs related to such officers and
employees and to contracts with such
contractors;
(B) management of information, and the
acquisition, maintenance, and repair of
computer resources;
(C) leasing, maintenance, renovation, and
repair of facilities and acquisition,
maintenance, and repair of fixtures, furniture,
scientific equipment, and other necessary
materials and supplies; and
(D) collecting fees under subsection (a) and
accounting for resources allocated for the
review of abbreviated new drug applications and
supplements and inspection related to generic
drugs.
[(12)] (13) The term ``Type II active pharmaceutical
ingredient drug master file'' means a submission of
information to the Secretary by a person that intends
to authorize the Food and Drug Administration to
reference the information to support approval of a
generic drug submission without the submitter having to
disclose the information to the generic drug submission
applicant.
SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.
(a) Types of Fees.--Beginning in [fiscal year 2013] fiscal
year 2018, the Secretary shall assess and collect fees in
accordance with this section as follows:
(1) One-time backlog fee for abbreviated new drug
applications pending on october 1, 2012.--
(A) In general.--Each person that owns an
abbreviated new drug application that is
pending on October 1, 2012, and that has not
received a tentative approval prior to that
date, shall be subject to a fee for each such
application, as calculated under subparagraph
(B).
(B) Method of fee amount calculation.--The
amount of each one-time backlog fee shall be
calculated by dividing $50,000,000 by the total
number of abbreviated new drug applications
pending on October 1, 2012, that have not
received a tentative approval as of that date.
(C) Notice.--Not later than October 31, 2012,
the Secretary shall publish in the Federal
Register a notice announcing the amount of the
fee required by subparagraph (A).
(D) Fee due date.--The fee required by
subparagraph (A) shall be due no later than 30
calendar days after the date of the publication
of the notice specified in subparagraph (C).
(E) Sunset.--This paragraph shall cease to be
effective October 1, 2022.
(2) Drug master file fee.--
(A) In general.--Each person that owns a Type
II active pharmaceutical ingredient drug master
file that is referenced on or after October 1,
2012, in a generic drug submission by any
initial letter of authorization shall be
subject to a drug master file fee.
(B) One-time payment.--If a person has paid a
drug master file fee for a Type II active
pharmaceutical ingredient drug master file, the
person shall not be required to pay a
subsequent drug master file fee when that Type
II active pharmaceutical ingredient drug master
file is subsequently referenced in generic drug
submissions.
[(C) Notice.--
[(i) Fiscal year 2013.--Not later
than October 31, 2012, the Secretary
shall publish in the Federal Register a
notice announcing the amount of the
drug master file fee for fiscal year
2013.
[(ii) Fiscal year 2014 through
2017.--Not later than 60 days before
the start of each of fiscal years 2014
through 2017, the Secretary shall
publish in the Federal Register the
amount of the drug master file fee
established by this paragraph for such
fiscal year.]
(C) Notice.--Not later than 60 days before
the start of each of fiscal years 2018 through
2022, the Secretary shall publish in the
Federal Register the amount of the drug master
file fee established by this paragraph for such
fiscal year.
(D) Availability for reference.--
(i) In general.--Subject to
subsection (g)(2)(C), for a generic
drug submission to reference a Type II
active pharmaceutical ingredient drug
master file, the drug master file must
be deemed available for reference by
the Secretary.
(ii) Conditions.--A drug master file
shall be deemed available for reference
by the Secretary if--
(I) the person that owns a
Type II active pharmaceutical
ingredient drug master file has
paid the fee required under
subparagraph (A) within 20
calendar days after the
applicable due date under
subparagraph (E); and
(II) the drug master file has
not failed an initial
completeness assessment by the
Secretary, in accordance with
criteria to be published by the
Secretary.
(iii) List.--The Secretary shall make
publicly available on the Internet Web
site of the Food and Drug
Administration a list of the drug
master file numbers that correspond to
drug master files that have
successfully undergone an initial
completeness assessment, in accordance
with criteria to be published by the
Secretary, and are available for
reference.
(E) Fee due date.--
(i) In general.--Subject to clause
(ii), a drug master file fee shall be
due [no later than the date] on the
earlier of--
(I) the date on which the
first generic drug submission
is submitted that references
the associated Type II active
pharmaceutical ingredient drug
master file[.]; or
(II) the date on which the
drug master file holder
requests the initial
completeness assessment.
(ii) Limitation.--No fee shall be due
under subparagraph (A) for a fiscal
year until the later of--
(I) 30 calendar days after
publication of the [notice
provided for in clause (i) or
(ii) of subparagraph (C), as
applicable] notice provided for
in subparagraph (C); or
(II) 30 calendar days after
the date of enactment of an
appropriations Act providing
for the collection and
obligation of fees for such
year under this section.
(3) Abbreviated new drug application [and prior
approval supplement] filing fee.--
(A) In general.--Each applicant that submits,
on or after October 1, 2012, an abbreviated new
drug application [or a prior approval
supplement to an abbreviated new drug
application] shall be subject to a fee for each
such submission in the amount established under
subsection (d).
[(B) Notice.--
[(i) Fiscal year 2013.--Not later
than October 31, 2012, the Secretary
shall publish in the Federal Register a
notice announcing the amount of the
fees under subparagraph (A) for fiscal
year 2013.
[(ii) Fiscal years 2014 through
2017.--Not later than 60 days before
the start of each of fiscal years 2014
through 2017, the Secretary shall
publish in the Federal Register the
amount of the fees under subparagraph
(A) for such fiscal year.
[(C) Fee due date.--
[(i) In general.--Except as provided
in clause (ii), the fees required by
subparagraphs (A) and (F) shall be due
no later than the date of submission of
the abbreviated new drug application or
prior approval supplement for which
such fee applies.
[(ii) Special rule for 2013.--For
fiscal year 2013, such fees shall be
due on the later of--
[(I) the date on which the
fee is due under clause (i);
[(II) 30 calendar days after
publication of the notice
referred to in subparagraph
(B)(i); or
[(III) if an appropriations
Act is not enacted providing
for the collection and
obligation of fees for such
year 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.]
(B) Notice.--Not later than 60 days before
the start of each of fiscal years 2018 through
2022, the Secretary shall publish in the
Federal Register the amount of the fees under
subparagraph (A) for such fiscal year.
(C) Fee due date.--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.
(D) Refund of fee if abbreviated new drug
application is not considered to have been
received, is withdrawn prior to being received,
or is no longer received.--[The Secretary shall
refund 75 percent of the fee paid under
subparagraph (A) for any abbreviated new drug
application or prior approval supplement to an
abbreviated new drug application that the
Secretary considers not to have been received
within the meaning of section 505(j)(5)(A) for
a cause other than failure to pay fees.]
(i) Applications not considered to
have been received and applications
withdrawn prior to being received._The
Secretary shall refund 75 percent of
the fee paid under subparagraph (A) for
any 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, or that
has been withdrawn prior to being
received within the meaning of section
505(j)(5)(A).
(ii) Applications no longer
received._The Secretary shall refund
100 percent of the fee paid under
subparagraph (A) for any abbreviated
new drug application if the Secretary
initially receives the application
under section 505(j)(5)(A) and
subsequently determines that an
exclusivity period for a listed drug
should have prevented the Secretary
from receiving such application, such
that the abbreviated new drug
application is no longer received
within the meaning of section
505(j)(5)(A).
(E) Fee for an application the secretary
considers not to have been received, or that
has been withdrawn.--An abbreviated new drug
application [or prior approval supplement] that
was submitted on or after October 1, 2012, and
that the Secretary considers not to have been
received, or that has been withdrawn, shall,
upon resubmission of the application or a
subsequent new submission following the
applicant's withdrawal of the application, be
subject to a full fee under subparagraph (A).
(F) Additional fee for active pharmaceutical
ingredient information not included by
reference to type ii active pharmaceutical
ingredient drug master file.--An applicant that
submits a generic drug submission on or after
October 1, [2012] 2017, shall pay a fee, in the
amount determined under [subsection (d)(3)]
subsection (d)(2), in addition to the fee
required under subparagraph (A), if--
(i) such submission contains
information concerning the manufacture
of an active pharmaceutical ingredient
at a facility by means other than
reference by a letter of authorization
to a Type II active pharmaceutical drug
master file; and
(ii) a fee in the amount equal to the
drug master file fee established in
paragraph (2) has not been previously
paid with respect to such information.
(4) Generic drug facility fee and active
pharmaceutical ingredient facility fee.--
(A) In general.--Facilities identified[, or
intended to be identified, in at least one
generic drug submission that is pending or] in
at least one generic drug submission that is
approved to produce a finished dosage form of a
human generic drug or an active pharmaceutical
ingredient contained in a human generic drug
shall be subject to fees as follows:
(i) Generic drug facility.--Each
person that owns a facility which is
identified [or intended to be
identified in at least one generic drug
submission that is pending or] in at
least one generic drug submission that
is approved to produce one or more
finished dosage forms of a human
generic drug shall be assessed an
annual fee for each such facility.
(ii) Active pharmaceutical ingredient
facility.--Each person that owns a
facility which [produces, or which is
pending review to produce, one or more
active pharmaceutical ingredients
identified, or intended to be
identified, in at least one generic
drug submission that is pending or
approved or in a Type II active
pharmaceutical ingredient drug master
file referenced in such a] is
identified in at least one generic drug
submission in which the facility is
approved to produce one or more active
pharmaceutical ingredients or in a Type
II active pharmaceutical ingredient
drug master file referenced in at least
one such generic drug submission, shall
be assessed an annual fee for each such
facility.
(iii) Facilities producing both
active pharmaceutical ingredients and
finished dosage forms.--Each person
that owns a facility identified[, or
intended to be identified, in at least
one generic drug submission that is
pending or] in at least one generic
drug submission that is 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] only to the fee
attributable to the manufacture of the
finished dosage forms for that
facility.
(B) Amount.--The amount of fees established
under subparagraph (A) shall be established
under subsection (d).
[(C) Notice.--
[(i) Fiscal year 2013.--For fiscal
year 2013, the Secretary shall publish
in the Federal Register a notice
announcing the amount of the fees
provided for in subparagraph (A) within
the timeframe specified in subsection
(d)(1)(B).
[(ii) Fiscal years 2014 through
2017.--Within the timeframe specified
in subsection (d)(2), the Secretary
shall publish in the Federal Register
the amount of the fees under
subparagraph (A) for such fiscal year.
[(D) Fee due date.--
[(i) Fiscal year 2013.--For fiscal
year 2013, the fees under subparagraph
(A) shall be due on the later of--
[(I) not later than 45 days
after the publication of the
notice under subparagraph (B);
or
[(II) if an appropriations
Act is not enacted providing
for the collection and
obligation of fees for such
year under this section by the
date of the publication of such
notice, 30 days after the date
that such an appropriations Act
is enacted.
[(ii) Fiscal years 2014 through
2017.--For each of fiscal years 2014
through 2017, the fees under
subparagraph (A) for such fiscal year
shall be due on the later of--
[(I) the first business day
on or after October 1 of each
such year; or
[(II) the first business day
after the enactment of an
appropriations Act providing
for the collection and
obligation of fees for such
year under this section for
such year.]
(C) Notice.--Within the timeframe specified
in subsection (d)(1), the Secretary shall
publish in the Federal Register the amount of
the fees under subparagraph (A) for such fiscal
year.
(D) Fee due date.--For each of fiscal years
2018 through 2022, the fees under subparagraph
(A) for such fiscal year shall be due on the
later of--
(i) the first business day on or
after October 1 of each such year; or
(ii) the first business day after the
enactment of an appropriations Act
providing for the collection and
obligation of fees for such year under
this section for such year.
(5) Generic drug applicant program fee.--
(A) In general.--A generic drug applicant
program fee shall be assessed annually as
described in subsection (b)(2)(E).
(B) Amount.--The amount of fees established
under subparagraph (A) shall be established
under subsection (d).
(C) Notice.--Within the timeframe specified
in subsection (d)(1), the Secretary shall
publish in the Federal Register the amount of
the fees under subparagraph (A) for such fiscal
year.
(D) Fee due date.--For each of fiscal years
2018 through 2022, the fees under subparagraph
(A) for such fiscal year shall be due on the
later of--
(i) the first business day on or
after October 1 of each such fiscal
year; or
(ii) the first business day after the
date of enactment of an appropriations
Act providing for the collection and
obligation of fees for such fiscal year
under this section for such fiscal
year.
[(5)] (6) Date of submission.--For purposes of this
Act, a generic drug submission or Type II
pharmaceutical master file is deemed to be
``submitted'' to the Food and Drug Administration--
(A) if it is submitted via a Food and Drug
Administration electronic gateway, on the day
when transmission to that electronic gateway is
completed, except that a submission or master
file that arrives on a weekend, Federal
holiday, or day when the Food and Drug
Administration office that will review that
submission is not otherwise open for business
shall be deemed to be submitted on the next day
when that office is open for business; or
(B) if it is submitted in physical media
form, on the day it arrives at the appropriate
designated document room of the Food and Drug
Administration.
(b) Fee Revenue Amounts.--
(1) In general.--
(A) Fiscal year [2013] 2018.--For fiscal year
[2013] 2018, fees under subsection (a) shall be
established to generate a total estimated
revenue amount under such subsection of
[$299,000,000] $493,600,000. [Of that amount--]
[(i) $50,000,000 shall be generated
by the one-time backlog fee for generic
drug applications pending on October 1,
2012, established in subsection (a)(1);
and
[(ii) $249,000,000 shall be generated
by the fees under paragraphs (2)
through (4) of subsection (a).]
(B) Fiscal years [2014 through 2017] 2019
through 2022.--For each of the fiscal years
[2014 through 2017] 2019 through 2022, fees
under [paragraphs (2) through (4)] paragraphs
(2) through (5) of subsection (a) shall be
established to generate a total estimated
revenue amount under such subsection that is
equal to [$299,000,000] $493,600,000, as
adjusted pursuant to subsection (c).
(2) Types of fees.--In establishing fees under
paragraph (1) to generate the revenue amounts specified
in [paragraph (1)(A)(ii) for fiscal year 2013 and
paragraph (1)(B) for each of fiscal years 2014 through
2017] such paragraph for a fiscal year, such fees shall
be derived from the fees under paragraphs (2) [through
(4)] through (5) of subsection (a) as follows:
(A) [Six percent] Five percent shall be
derived from fees under subsection (a)(2)
(relating to drug master files).
[(B) Twenty-four percent shall be derived
from fees under subsection (a)(3) (relating to
abbreviated new drug applications and
supplements). The amount of a fee for a prior
approval supplement shall be half the amount of
the fee for an abbreviated new drug
application.
[(C) Fifty-six percent shall be derived from
fees under subsection (a)(4)(A)(i) (relating to
generic drug facilities). The amount of the fee
for a facility located outside the United
States and its territories and possessions
shall be not less than $15,000 and not more
than $30,000 higher than the amount of the fee
for a facility located in the United States and
its territories and possessions, as determined
by the Secretary on the basis of data
concerning the difference in cost between
inspections of facilities located in the United
States, including its territories and
possessions, and those located outside of the
United States and its territories and
possessions.]
(B) Thirty-three percent shall be derived
from fees under subsection (a)(3) (relating to
abbreviated new drug applications).
(C) Twenty percent shall be derived from fees
under subsection (a)(4)(A)(i) (relating to
generic drug facilities). The amount of the fee
for a contract manufacturing organization
facility shall be equal to one-third the amount
of the fee for a facility that is not a
contract manufacturing organization facility.
The amount of the fee for a facility located
outside the United States and its territories
and possessions shall be $15,000 higher than
the amount of the fee for a facility located in
the United States and its territories and
possessions.
(D) [Fourteen percent] Seven 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] $15,000 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.].
(E)(i) Thirty-five percent shall be derived
from fees under subsection (a)(5) (relating to
generic drug applicant program fees). For
purposes of this subparagraph, if a person has
affiliates, a single program fee shall be
assessed with respect to that person, including
its affiliates, and may be paid by that person
or any one of its affiliates. The Secretary
shall determine the fees as follows:
(I) If a person (including its
affiliates) owns at least one but not
more than 5 approved abbreviated new
drug applications on the due date for
the fee under this subsection, the
person (including its affiliates) shall
be assessed a small business generic
drug applicant program fee equal to
one-tenth of the large size operation
generic drug applicant program fee.
(II) If a person (including its
affiliates) owns at least 6 but not
more than 19 approved abbreviated new
drug applications on the due date for
the fee under this subsection, the
person (including its affiliates) shall
be assessed a medium size operation
generic drug applicant program fee
equal to two-fifths of the large size
operation generic drug applicant
program fee.
(III) If a person (including its
affiliates) owns 20 or more approved
abbreviated new drug applications on
the due date for the fee under this
subsection, the person (including its
affiliates) shall be assessed a large
size operation generic drug applicant
program fee.
(ii) For purposes of this subparagraph, an
abbreviated new drug application shall be
deemed not to be approved if the applicant has
submitted a written request for withdrawal of
approval of such abbreviated new drug
application by April 1 of the previous fiscal
year.
(c) Adjustments.--
(1) Inflation adjustment.--For fiscal year [2014]
2019 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, to equal the product of the total
revenues established in such notice for the prior
fiscal year multiplied by an amount equal to the sum
of--
(A) one;
(B) the average annual percent change in the
cost, per full-time equivalent position of the
Food and Drug Administration, of all personnel
compensation and benefits paid with respect to
such positions for the first 3 years of the
preceding 4 fiscal years multiplied by the
proportion of personnel compensation and
benefits costs to total costs of human generic
drug activities for the first 3 years of the
preceding 4 fiscal years; and
(C) the average annual percent change that
occurred in the Consumer Price Index for urban
consumers (Washington-Baltimore, DC-MD-VA-WV;
Not Seasonally Adjusted; All items; Annual
Index) for the first 3 years of the preceding 4
years of available data multiplied by the
proportion of all costs other than personnel
compensation and benefits costs to total costs
of human generic drug activities for the first
3 years of the preceding 4 fiscal years.
[The adjustment made each fiscal year under this
subsection shall be added on a compounded basis to the
sum of all adjustments made each fiscal year after
fiscal year 2013 under this subsection.]
(2) Final year adjustment.--For fiscal year [2017]
2022, 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] the first 3 months of fiscal year
2023. [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] 2022. If the Secretary has carryover
balances for such activities in excess of 3 months of
such operating reserves, the adjustment under this
subparagraph shall not be made.
(d) Annual Fee Setting.--
[(1) Fiscal year 2013.--For fiscal year 2013--
[(A) the Secretary shall establish, by
October 31, 2012, the one-time generic drug
backlog fee for generic drug applications
pending on October 1, 2012, the drug master
file fee, the abbreviated new drug application
fee, and the prior approval supplement fee
under subsection (a), based on the revenue
amounts established under subsection (b); and
[(B) the Secretary shall establish, not later
than 45 days after the date to comply with the
requirement for identification of facilities in
subsection (f)(2), the generic drug facility
fee and active pharmaceutical ingredient
facility fee under subsection (a) based on the
revenue amounts established under subsection
(b).
[(2) Fiscal years 2014 through 2017.--Not more than
60 days before the first day of each of fiscal years
2014 through 2017, the Secretary shall establish the
drug master file fee, the abbreviated new drug
application fee, the prior approval supplement fee, the
generic drug facility fee, and the active
pharmaceutical ingredient facility fee under subsection
(a) for such fiscal year, based on the revenue amounts
established under subsection (b) and the adjustments
provided under subsection (c).]
(1) Fiscal years 2018 through 2022.--Not more than 60
days before the first day of each of fiscal years 2018
through 2022, the Secretary shall establish the fees
described in paragraphs (2) through (5) of subsection
(a), based on the revenue amounts established under
subsection (b) and the adjustments provided under
subsection (c).
[(3)] (2) Fee for active pharmaceutical ingredient
information not included by reference to type ii active
pharmaceutical ingredient drug master file.--In
establishing the [fees under paragraphs (1) and (2)]
fee under paragraph (1), the amount of the fee under
subsection (a)(3)(F) shall be determined by
multiplying--
(A) the sum of--
(i) the total number of such active
pharmaceutical ingredients in such
submission; and
(ii) for each such ingredient that is
manufactured at more than one such
facility, the total number of such
additional facilities; and
(B) the amount equal to the drug master file
fee established in subsection (a)(2) for such
submission.
(e) Limit.--The total amount of fees charged, as adjusted
under subsection (c), for a fiscal year may not exceed the
total costs for such fiscal year for the resources allocated
for human generic drug activities.
(f) Identification of Facilities.--
[(1) Publication of notice; deadline for
compliance.--Not later than October 1, 2012, the
Secretary shall publish in the Federal Register a
notice requiring each person that owns a facility
described in subsection (a)(4)(A), or a site or
organization required to be identified by paragraph
(4), to submit to the Secretary information on the
identity of each such facility, site, or organization.
The notice required by this paragraph shall specify the
type of information to be submitted and the means and
format for submission of such information.]
[(2)] (1) Required submission of facility
identification.--Each person that owns a facility
described in subsection (a)(4)(A) or a site or
organization required to be identified by [paragraph
(4)] paragraph (3) shall submit to the Secretary the
information required under this subsection each year.
[Such information shall--
[(A) for fiscal year 2013, be submitted not
later than 60 days after the publication of the
notice under paragraph (1); and
[(B) for each subsequent fiscal year, be
submitted, updated, or reconfirmed on or before
June 1 of the previous year.] Such information
shall, for each fiscal year, be submitted,
updated, or reconfirmed on or before June 1 of
the previous fiscal year.
[(3) Contents of notice.--] (2) Information required
to be submitted._At a minimum, the submission required
by [paragraph (2)] paragraph (1) shall include for each
such facility--
(A) identification of a facility identified
[or intended to be identified] in an approved
or pending generic drug submission;
(B) whether the facility manufactures active
pharmaceutical ingredients or finished dosage
forms, or both;
(C) whether or not the facility is located
within the United States and its territories
and possessions;
(D) whether the facility manufactures
positron emission tomography drugs solely, or
in addition to other drugs; [and]
(E) whether the facility manufactures drugs
that are not generic drugs[.]; and
(F) whether the facility is a contract
manufacturing organization facility.
[(4)] (3) Certain sites and organizations.--
(A) In general.--Any person that owns or
operates a site or organization described in
subparagraph (B) shall submit to the Secretary
information concerning the ownership, name, and
address of the site or organization.
(B) Sites and organizations.--A site or
organization is described in this subparagraph
if it is identified in a generic drug
submission and is--
(i) a site in which a bioanalytical
study is conducted;
(ii) a clinical research
organization;
(iii) a contract analytical testing
site; or
(iv) a contract repackager site.
(C) Notice.--The Secretary may, by notice
published in the Federal Register, specify the
means and format for submission of the
information under subparagraph (A) and may
specify, as necessary for purposes of this
section, any additional information to be
submitted.
(D) Inspection authority.--The Secretary's
inspection authority under section 704(a)(1)
shall extend to all such sites and
organizations.
(g) Effect of Failure To Pay Fees.--
(1) Generic drug backlog fee.--Failure to pay the fee
under subsection (a)(1) shall result in the Secretary
placing the person that owns the abbreviated new drug
application subject to that fee on a publicly available
arrears list, such that no new abbreviated new drug
applications or supplement submitted on or after
October 1, 2012, from that person, or any affiliate of
that person, will be received within the meaning of
section 505(j)(5)(A) until such outstanding fee is
paid. This paragraph shall cease to be effective on
October 1, 2022.
(2) Drug master file fee.--
(A) Failure to pay the fee under subsection
(a)(2) within 20 calendar days after the
applicable due date under subparagraph (E) of
such subsection (as described in subsection
(a)(2)(D)(ii)(I)) shall result in the Type II
active pharmaceutical ingredient drug master
file not being deemed available for reference.
(B)(i) Any generic drug submission submitted
on or after October 1, 2012, that references,
by a letter of authorization, a Type II active
pharmaceutical ingredient drug master file that
has not been deemed available for reference
shall not be received within the meaning of
section 505(j)(5)(A) unless the condition
specified in clause (ii) is met.
(ii) The condition specified in this clause
is that the fee established under subsection
(a)(2) has been paid within 20 calendar days of
the Secretary providing the notification to the
sponsor of the abbreviated new drug application
or supplement of the failure of the owner of
the Type II active pharmaceutical ingredient
drug master file to pay the drug master file
fee as specified in subparagraph (C).
(C)(i) If an abbreviated new drug application
or supplement to an abbreviated new drug
application references a Type II active
pharmaceutical ingredient drug master file for
which a fee under subsection (a)(2)(A) has not
been paid by the applicable date under
subsection (a)(2)(E), the Secretary shall
notify the sponsor of the abbreviated new drug
application or supplement of the failure of the
owner of the Type II active pharmaceutical
ingredient drug master file to pay the
applicable fee.
(ii) If such fee is not paid within 20
calendar days of the Secretary providing the
notification, the abbreviated new drug
application or supplement to an abbreviated new
drug application shall not be received within
the meaning [of 505(j)(5)(A)] of section
505(j)(5)(A).
(3) Abbreviated new drug application fee and prior
approval supplement fee.--Failure to pay a fee under
subparagraph (A) or (F) of subsection (a)(3) within 20
calendar days of the applicable due date under
subparagraph (C) of such subsection shall result in the
abbreviated new drug application or the prior approval
supplement to an abbreviated new drug application not
being received within the meaning of section
505(j)(5)(A) until such outstanding fee is paid.
(4) Generic drug facility fee and active
pharmaceutical ingredient facility fee.--
(A) In general.--Failure to pay the fee under
subsection (a)(4) within 20 calendar days of
the due date as specified in subparagraph (D)
of such subsection shall result in the
following:
(i) The Secretary shall place the
facility on a publicly available
arrears list, such that no new
abbreviated new drug application or
supplement submitted on or after
October 1, 2012, from the person that
is responsible for paying such fee, or
any affiliate of that person, will be
received within the meaning of section
505(j)(5)(A).
(ii) Any new generic drug submission
submitted on or after October 1, 2012,
that references such a facility shall
not be received, within the meaning of
section 505(j)(5)(A) if the outstanding
facility fee is not paid within 20
calendar days of the Secretary
providing the notification to the
sponsor of the failure of the owner of
the facility to pay the facility fee
under subsection (a)(4)(C).
(iii) All drugs or active
pharmaceutical ingredients manufactured
in such a facility or containing an
ingredient manufactured in such a
facility shall be deemed misbranded
under section 502(aa).
(B) Application of penalties.--The penalties
under this paragraph shall apply until the fee
established by subsection (a)(4) is paid or the
facility is removed from all generic drug
submissions that refer to the facility.
(C) Nonreceival for nonpayment.--
(i) Notice.--If an abbreviated new
drug application or supplement to an
abbreviated new drug application
submitted on or after October 1, 2012,
references a facility for which a
facility fee has not been paid by the
applicable date under subsection
(a)(4)(C), the Secretary shall notify
the sponsor of the generic drug
submission of the failure of the owner
of the facility to pay the facility
fee.
(ii) Nonreceival.--If the facility
fee is not paid within 20 calendar days
of the Secretary providing the
notification under clause (i), the
abbreviated new drug application or
supplement to an abbreviated new drug
application shall not be received
within the meaning of section
505(j)(5)(A).
(5) Generic drug applicant program fee.--
(A) In general.--A person who fails to pay a
fee as required under subsection (a)(5) by the
date that is 20 calendar days after the due
date, as specified in subparagraph (D) of such
subsection, shall be subject to the following:
(i) The Secretary shall place the
person on a publicly available arrears
list.
(ii) Any abbreviated new drug
application submitted by the generic
drug applicant or an affiliate of such
applicant shall not be received, within
the meaning of section 505(j)(5)(A).
(iii) All drugs marketed pursuant to
any abbreviated new drug application
held by such applicant or an affiliate
of such applicant shall be deemed
misbranded under section 502(aa).
(B) Application of penalties.--The penalties
under subparagraph (A) shall apply until the
fee required under subsection (a)(5) is paid.
(h) Limitations.--
(1) In general.--Fees under subsection (a) shall be
refunded for a fiscal year beginning after fiscal year
2012, unless appropriations for salaries and expenses
of the Food and Drug Administration for such fiscal
year (excluding the amount of fees appropriated for
such fiscal year) are equal to or greater than the
amount of appropriations for the salaries and expenses
of the Food and Drug Administration for fiscal year
2009 (excluding the amount of fees appropriated for
such fiscal year) multiplied by the adjustment factor
(as defined in section 744A) applicable to the fiscal
year involved.
(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal
year and if at a later date in such fiscal year the
Secretary may assess such fees, the Secretary may
assess and collect such fees, without any modification
in the rate, [for Type II active pharmaceutical
ingredient drug master files, abbreviated new drug
applications and prior approval supplements, and
generic drug facilities and active pharmaceutical
ingredient facilities] at any time in such fiscal year
notwithstanding the provisions of subsection (a)
relating to the date fees are to be paid.
(i) Crediting and Availability of Fees.--
(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to
the extent and in the amount provided in advance in
appropriations Acts, subject to paragraph (2). Such
fees are authorized to remain available until expended.
Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to
such appropriation account for salaries and expenses
with such fiscal year limitation. The sums transferred
shall be available solely for human generic drug
activities.
(2) Collections and appropriation acts.--
(A) In general.--The fees authorized by this
section--
(i) subject to subparagraphs (C) and
(D), shall be collected and available
in each fiscal year in an amount not to
exceed the amount specified in
appropriation Acts, or otherwise made
available for obligation for such
fiscal year; and
(ii) shall be available for a fiscal
year beginning after fiscal year 2012
to defray the costs of human generic
drug activities (including such costs
for an additional number of full-time
equivalent positions in the Department
of Health and Human Services to be
engaged in such activities), only if
the Secretary allocates for such
purpose an amount for such fiscal year
(excluding amounts from fees collected
under this section) no less than
$97,000,000 multiplied by the
adjustment factor defined in section
744A(3) applicable to the fiscal year
involved.
(B) Compliance.--The Secretary shall be
considered to have met the requirements of
subparagraph (A)(ii) in any fiscal year if the
costs funded by appropriations and allocated
for human generic activities are not more than
10 percent below the level specified in such
subparagraph.
[(C) Fee collection during first program
year.--Until the date of enactment of an Act
making appropriations through September 30,
2013, for the salaries and expenses account of
the Food and Drug Administration, fees
authorized by this section for fiscal year 2013
may be collected and shall be credited to such
account and remain available until expended.
[(D)] (C) Provision for early payments [in
subsequent years].--Payment of fees authorized
under this section for a fiscal year [(after
fiscal year 2013)], prior to the due date for
such fees, may be accepted by the Secretary in
accordance with authority provided in advance
in a prior year appropriations Act.
(3) Authorization of appropriations.--For each of the
[fiscal years 2013 through 2017] fiscal years 2018
through 2022, there is authorized to be appropriated
for fees under this section an amount equivalent to the
total revenue amount determined under subsection (b)
for the fiscal year, as adjusted under subsection (c),
if applicable, or as otherwise affected under paragraph
(2) of this subsection.
(j) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 calendar days after it is due, such
fee shall be treated as a claim of the United States Government
subject to subchapter II of chapter 37 of title 31, United
States Code.
(k) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in human generic
drug activities, be reduced to offset the number of officers,
employees, and advisory committees so engaged.
(l) Positron Emission Tomography Drugs.--
(1) Exemption from fees.--Submission of an
application for a positron emission tomography drug or
active pharmaceutical ingredient for a positron
emission tomography drug shall not require the payment
of any fee under this section. Facilities that solely
produce positron emission tomography drugs shall not be
required to pay a facility fee as established in
subsection (a)(4).
(2) Identification requirement.--Facilities that
produce positron emission tomography drugs or active
pharmaceutical ingredients of such drugs are required
to be identified pursuant to subsection (f).
(m) Disputes Concerning Fees.--To qualify for the return of a
fee claimed to have been paid in error under this section, a
person shall submit to the Secretary a written request
justifying such return within 180 calendar days after such fee
was paid.
(n) Substantially Complete Applications.--An abbreviated new
drug application that is not considered to be received within
the meaning of section 505(j)(5)(A) because of failure to pay
an applicable fee under this provision within the time period
specified in subsection (g) shall be deemed not to have been
``substantially complete'' on the date of its submission within
the meaning of section 505(j)(5)(B)(iv)(II)(cc). An abbreviated
new drug application that is not substantially complete on the
date of its submission solely because of failure to pay an
applicable fee under the preceding sentence shall be deemed
substantially complete and received within the meaning of
section 505(j)(5)(A) as of the date such applicable fee is
received.
(o) Information on Abbreviated New Drug Applications Owned by
Applicants and Their Affiliates.--
(1) In general.--By April 1 of each year, each person
that owns an abbreviated new drug application, or any
affiliate of such person, shall submit, on behalf of
the person and its affiliates, to the Secretary a list
of--
(A) all approved abbreviated new drug
applications owned by such person; and
(B) if any affiliate of such person also owns
an abbreviated new drug application, all
affiliates that own any such abbreviated new
drug applications and all approved abbreviated
new drug applications owned by any such
affiliate.
(2) Format and method.--The Secretary shall specify
in guidance the format and method for submission of
lists under this subsection.
SEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Report.--Beginning with fiscal year [2013]
2018, not later than 120 days after the end of each fiscal year
for which fees are collected under this part, the Secretary
shall prepare and submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a report
concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in
section 301(b) of the [Generic Drug User Fee Amendments of
2012] Generic Drug User Fee Amendments of 2017 during such
fiscal year and the future plans of the Food and Drug
Administration for meeting the goals.
(b) Fiscal Report.--Beginning with fiscal year [2013] 2018,
not later than 120 days after the end of each fiscal year for
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected for such fiscal year.
(c) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to the
public on the Internet Web site of the Food and Drug
Administration.
(d) Reauthorization.--
(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals, and
plans for meeting the goals, for human generic drug
activities for the first 5 fiscal years after fiscal
year [2017] 2022, and for the reauthorization of this
part for such fiscal years, the Secretary shall consult
with--
(A) the Committee on Energy and Commerce of
the House of Representatives;
(B) the Committee on Health, Education,
Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer
advocacy groups; and
(F) the generic drug industry.
(2) Prior public input.--Prior to beginning
negotiations with the generic drug industry on the
reauthorization of this part, the Secretary shall--
(A) publish a notice in the Federal Register
requesting public input on the reauthorization;
(B) hold a public meeting at which the public
may present its views on the reauthorization,
including specific suggestions for changes to
the goals referred to in subsection (a);
(C) provide a period of 30 days after the
public meeting to obtain written comments from
the public suggesting changes to this part; and
(D) publish the comments on the Food and Drug
Administration's Internet Web site.
(3) Periodic consultation.--Not less frequently than
once every month during negotiations with the generic
drug industry, the Secretary shall hold discussions
with representatives of patient and consumer advocacy
groups to continue discussions of their views on the
reauthorization and their suggestions for changes to
this part as expressed under paragraph (2).
(4) Public review of recommendations.--After
negotiations with the generic drug industry, the
Secretary shall--
(A) present the recommendations developed
under paragraph (1) to the congressional
committees specified in such paragraph;
(B) publish such recommendations in the
Federal Register;
(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
(D) hold a meeting at which the public may
present its views on such recommendations; and
(E) after consideration of such public views
and comments, revise such recommendations as
necessary.
(5) Transmittal of recommendations.--Not later than
January 15, [2017] 2022, the Secretary shall transmit
to the Congress the revised recommendations under
paragraph (4), a summary of the views and comments
received under such paragraph, and any changes made to
the recommendations in response to such views and
comments.
(6) Minutes of negotiation meetings.--
(A) Public availability.--Before presenting
the recommendations developed under paragraphs
(1) through (5) to the Congress, the Secretary
shall make publicly available, on the Internet
Web site of the Food and Drug Administration,
minutes of all negotiation meetings conducted
under this subsection between the Food and Drug
Administration and the generic drug industry.
(B) Content.--The minutes described under
subparagraph (A) shall summarize any
substantive proposal made by any party to the
negotiations as well as significant
controversies or differences of opinion during
the negotiations and their resolution.
PART 8--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 744G. DEFINITIONS.
For purposes of this part:
[(1) The term ``adjustment factor'' applicable to a
fiscal year that is the Consumer Price Index for all
urban consumers (Washington-Baltimore, DC-MD-VA-WV; Not
Seasonally Adjusted; All items) of the preceding fiscal
year divided by such Index for September 2011.]
(1) The term ``adjustment factor'' applicable to a
fiscal year is the Consumer Price Index for urban
consumers (Washington-Baltimore, DC-MD-VA-WV; Not
Seasonally Adjusted; All items; Annual Index) for
October of the preceding fiscal year divided by such
Index for October 2011.
(2) The term ``affiliate'' means a business entity
that has a relationship with a second business entity
if, directly or indirectly--
(A) one business entity controls, or has the
power to control, the other business entity; or
(B) a third party controls, or has power to
control, both of the business entities.
(3) The term ``biosimilar biological product'' [means
a product] means a specific strength of a biological
product in final dosage form for which a biosimilar
biological product application has been approved.
(4)(A) Subject to subparagraph (B), the term
``biosimilar biological product application'' means an
application for licensure of a biological product under
section 351(k) of the Public Health Service Act.
(B) Such term does not include--
(i) a supplement to such an application;
(ii) an application filed under section
351(k) of the Public Health Service Act that
cites as the reference product a bovine blood
product for topical application licensed before
September 1, 1992, or a large volume parenteral
drug product approved before such date;
(iii) an application filed under section
351(k) of the Public Health Service Act with
respect to--
(I) whole blood or a blood component
for transfusion;
(II) an allergenic extract product;
(III) an in vitro diagnostic
biological product; or
(IV) a biological product for further
manufacturing use only; or
(iv) an application for licensure under
section 351(k) of the Public Health Service Act
that is submitted by a State or Federal
Government entity for a product that is not
distributed commercially.
(5) The term ``biosimilar biological product
development meeting'' means any meeting, other than a
biosimilar initial advisory meeting, regarding the
content of a development program, including a proposed
design for, or data from, a study intended to support a
biosimilar biological product application.
(6) The term ``biosimilar biological product
development program'' means the program under this part
for expediting the process for the review of
submissions in connection with biosimilar biological
product development.
(7)(A) The term ``biosimilar biological product
establishment'' means a foreign or domestic place of
business--
(i) that is at one general physical location
consisting of one or more buildings, all of
which are within 5 miles of each other; and
(ii) at which one or more biosimilar
biological products are manufactured in final
dosage form.
(B) For purposes of subparagraph (A)(ii), the term
``manufactured'' does not include packaging.
(8) The term ``biosimilar initial advisory
meeting''--
(A) means a meeting, if requested, that is
limited to--
(i) a general discussion regarding
whether licensure under section 351(k)
of the Public Health Service Act may be
feasible for a particular product; and
(ii) if so, general advice on the
expected content of the development
program; and
(B) does not include any meeting that
involves substantive review of summary data or
full study reports.
(9) The term ``costs of resources allocated for the
process for the review of biosimilar biological product
applications'' means the expenses in connection with
the process for the review of biosimilar biological
product applications for--
(A) officers and employees of the Food and
Drug Administration, contractors of the Food
and Drug Administration, advisory committees,
and costs related to such officers employees
and committees and to contracts with such
contractors;
(B) management of information, and the
acquisition, maintenance, and repair of
computer resources;
(C) leasing, maintenance, renovation, and
repair of facilities and acquisition,
maintenance, and repair of fixtures, furniture,
scientific equipment, and other necessary
materials and supplies; and
(D) collecting fees under section 744H and
accounting for resources allocated for the
review of submissions in connection with
biosimilar biological product development,
biosimilar biological product applications, and
supplements.
(10) The term ``final dosage form'' means, with
respect to a biosimilar biological product, a finished
dosage form which is approved for administration to a
patient without substantial further manufacturing (such
as lyophilized products before reconstitution).
(11) The term ``financial hold''--
(A) means an order issued by the Secretary to
prohibit the sponsor of a clinical
investigation from continuing the investigation
if the Secretary determines that the
investigation is intended to support a
biosimilar biological product application and
the sponsor has failed to pay any fee for the
product required under subparagraph (A), (B),
or (D) of section 744H(a)(1); and
(B) does not mean that any of the bases for a
``clinical hold'' under section 505(i)(3) have
been determined by the Secretary to exist
concerning the investigation.
(12) The term ``person'' includes an affiliate of
such person.
(13) The term ``process for the review of biosimilar
biological product applications'' means the following
activities of the Secretary with respect to the review
of submissions in connection with biosimilar biological
product development, biosimilar biological product
applications, and supplements:
(A) The activities necessary for the review
of submissions in connection with biosimilar
biological product development, biosimilar
biological product applications, and
supplements.
(B) Actions related to submissions in
connection with biosimilar biological product
development, the issuance of action letters
which approve biosimilar biological product
applications or which set forth in detail the
specific deficiencies in such applications, and
where appropriate, the actions necessary to
place such applications in condition for
approval.
(C) The inspection of biosimilar biological
product establishments and other facilities
undertaken as part of the Secretary's review of
pending biosimilar biological product
applications and supplements.
(D) Activities necessary for the release of
lots of biosimilar biological products under
section 351(k) of the Public Health Service
Act.
(E) Monitoring of research conducted in
connection with the review of biosimilar
biological product applications.
(F) Postmarket safety activities with respect
to biologics approved under biosimilar
biological product applications or supplements,
including the following activities:
(i) Collecting, developing, and
reviewing safety information on
biosimilar biological products,
including adverse-event reports.
(ii) Developing and using improved
adverse-event data-collection systems,
including information technology
systems.
(iii) Developing and using improved
analytical tools to assess potential
safety problems, including access to
external data bases.
(iv) Implementing and enforcing
section 505(o) (relating to
postapproval studies and clinical
trials and labeling changes) and
section 505(p) (relating to risk
evaluation and mitigation strategies).
(v) Carrying out section 505(k)(5)
(relating to adverse-event reports and
postmarket safety activities).
(14) The term ``supplement'' means a request to the
Secretary to approve a change in a biosimilar
biological product application which has been approved,
including a supplement requesting that the Secretary
determine that the biosimilar biological product meets
the standards for interchangeability described in
section 351(k)(4) of the Public Health Service Act.
SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL PRODUCT
FEES.
(a) Types of Fees.--Beginning in [fiscal year 2013] fiscal
year 2018, the Secretary shall assess and collect fees in
accordance with this section as follows:
(1) [Biosimilar] Biosimilar biological product
development program fees.--
(A) Initial biosimilar biological product
development fee.--
(i) In general.--Each person that
submits to the Secretary a meeting
request described under clause (ii) or
a clinical protocol for an
investigational new drug protocol
described under clause (iii) shall pay
for the product named in the meeting
request or the investigational new drug
application the initial biosimilar
biological product development fee
established under subsection
[(b)(1)(A)] (c)(5).
(ii) Meeting request.--The meeting
request described in this clause is a
request for a biosimilar biological
product development meeting for a
product.
(iii) Clinical protocol for ind.--A
clinical protocol for an
investigational new drug protocol
described in this clause is a clinical
protocol consistent with the provisions
of section 505(i), including any
regulations promulgated under section
505(i), (referred to in this section as
``investigational new drug
application'') describing an
investigation that the Secretary
determines is intended to support a
biosimilar biological product
application for a product.
(iv) Due date.--The initial
biosimilar biological product
development fee shall be due by the
earlier of the following:
(I) Not later than 5 days
after the Secretary grants a
request for a biosimilar
biological product development
meeting.
(II) The date of submission
of an investigational new drug
application describing an
investigation that the
Secretary determines is
intended to support a
biosimilar biological product
application.
(v) Transition rule.--Each person
that has submitted an investigational
new drug application prior to the date
of enactment of the Biosimilar User Fee
Act of 2012 shall pay the initial
biosimilar biological product
development fee by the earlier of the
following:
(I) Not later than 60 days
after the date of the enactment
of the Biosimilar User Fee Act
of 2012, if the Secretary
determines that the
investigational new drug
application describes an
investigation that is intended
to support a biosimilar
biological product application.
(II) Not later than 5 days
after the Secretary grants a
request for a biosimilar
biological product development
meeting.
(B) Annual biosimilar biological product
development fee.--
(i) In general.--A person that pays
an initial biosimilar biological
product development fee for a product
shall pay for such product, beginning
in the fiscal year following the fiscal
year in which the initial biosimilar
biological product development fee was
paid, an annual fee established under
subsection [(b)(1)(B) for biosimilar
biological product development] (c)(5)
for the biosimilar biological product
development program (referred to in
this section as ``annual biosimilar
biological product development fee'').
(ii) Due date.--The [annual
biosimilar biological product
development program fee] annual
biosimilar biological product
development fee for each fiscal year
will be due on the later of--
(I) the first business day on
or after October 1 of each such
year; or
(II) the first business day
after the enactment of an
appropriations Act providing
for the collection and
obligation of fees for such
year under this section.
(iii) Exception.--The [annual
biosimilar development program fee]
annual biosimilar biological product
development fee for each fiscal year
will be due on the date specified in
clause (ii), unless the person has--
(I) submitted a marketing
application for the biological
product that was accepted for
filing; or
(II) discontinued
participation in the biosimilar
biological product development
program for the product under
subparagraph (C).
(iv) Refund.--If a person submits a
marketing application for a biosimilar
biological product before October 1 of
a fiscal year and such application is
accepted for filing on or after October
1 of such fiscal year, the person may
request a refund equal to the annual
biosimilar development fee paid by the
person for the product for such fiscal
year. To qualify for consideration for
a refund under this clause, a person
shall submit to the Secretary a written
request for such refund not later than
180 days after the marketing
application is accepted for filing.
(C) Discontinuation of fee obligation.--A
person may discontinue participation in the
biosimilar biological product development
program [for a product effective October 1 of a
fiscal year by,] for a product, effective
October 1 of a fiscal year, by, not later than
August 1 of the preceding fiscal year--
(i) if no investigational new drug
application concerning the product has
been submitted, submitting to the
Secretary a written declaration that
the person has no present intention of
further developing the product as a
biosimilar biological product; or
(ii) if an investigational new drug
application concerning the product has
been submitted, withdrawing the
investigational new drug application in
accordance with part 312 of title 21,
Code of Federal Regulations (or any
successor regulations).
(D) Reactivation fee.--
(i) In general.--A person that has
discontinued participation in the
biosimilar biological product
development program for a product under
subparagraph (C) shall, if the person
seeks to resume participation in such
program, pay a fee (referred to in this
section as ``reactivation fee'') by the
earlier of the following:
(I) Not later than 5 days
after the Secretary grants a
request by such person for a
biosimilar biological product
development meeting for the
product (after the date on
which such participation was
discontinued).
(II) Upon the date of
submission (after the date on
which such participation was
discontinued) by such person of
an investigational new drug
application describing an
investigation that the
Secretary determines is
intended to support a
biosimilar biological product
application for that product.
(ii) Application of annual fee.--A
person that pays a reactivation fee for
a product shall pay for such product,
beginning in the next fiscal year, the
annual biosimilar biological product
development fee under subparagraph (B).
(E) Effect of failure to pay [biosimilar
development program] fees.--
(i) No biosimilar biological product
development meetings.--If a person has
failed to pay an initial or annual
biosimilar biological product
development fee as required under
subparagraph (A) or (B), or a
reactivation fee as required under
subparagraph (D), the Secretary shall
not provide a biosimilar biological
product development meeting relating to
the product for which fees are owed.
(ii) No receipt of investigational
new drug applications.--Except in
extraordinary circumstances, the
Secretary shall not consider an
investigational new drug application to
have been received under section
505(i)(2) if--
(I) the Secretary determines
that the investigation is
intended to support a
biosimilar biological product
application; and
(II) the sponsor has failed
to pay an initial or annual
biosimilar biological product
development fee for the product
as required under subparagraph
(A) or (B), or a reactivation
fee as required under
subparagraph (D).
(iii) Financial hold.--
Notwithstanding section 505(i)(2),
except in extraordinary circumstances,
the Secretary shall prohibit the
sponsor of a clinical investigation
from continuing the investigation if--
(I) the Secretary determines
that the investigation is
intended to support a
biosimilar biological product
application; and
(II) the sponsor has failed
to pay an initial or annual
biosimilar biological product
development fee for the product
as required under subparagraph
(A) or (B), or a reactivation
fee for the product as required
under subparagraph (D).
(iv) No acceptance of biosimilar
biological product applications or
supplements.--If a person has failed to
pay an initial or annual biosimilar
biological product development fee as
required under subparagraph (A) or (B),
or a reactivation fee as required under
subparagraph (D), any biosimilar
biological product application or
supplement submitted by that person
shall be considered incomplete and
shall not be accepted for filing by the
Secretary until all such fees owed by
such person have been paid.
(F) Limits regarding [biosimilar development
program] fees.--
[(i) No refunds.--The Secretary shall
not refund any initial or annual
biosimilar biological product
development fee paid under subparagraph
(A) or (B), or any reactivation fee
paid under subparagraph (D).]
(i) Refunds.--Except as provided in
subparagraph (B)(iv), the Secretary
shall not refund any initial or annual
biosimilar biological product
development fee paid under subparagraph
(A) or (B), or any reactivation fee
paid under subparagraph (D).
(ii) No waivers, exemptions, or
reductions.--The Secretary shall not
grant a waiver, exemption, or reduction
of any initial or annual biosimilar
biological product development fee due
or payable under subparagraph (A) or
(B), or any reactivation fee due or
payable under subparagraph (D).
(2) Biosimilar biological product application [and
supplement] fee.--
[(A) In general.--Each person that submits,
on or after October 1, 2012, a biosimilar
biological product application or a supplement
shall be subject to the following fees:
[(i) A fee for a biosimilar
biological product application that is
equal to--
[(I) the amount of the fee
established under subsection
(b)(1)(D) for a biosimilar
biological product application
for which clinical data (other
than comparative
bioavailability studies) with
respect to safety or
effectiveness are required for
approval; minus
[(II) the cumulative amount
of fees paid, if any, under
subparagraphs (A), (B), and (D)
of paragraph (1) for the
product that is the subject of
the application.
[(ii) A fee for a biosimilar
biological product application for
which clinical data (other than
comparative bioavailability studies)
with respect to safety or effectiveness
are not required, that is equal to--
[(I) half of the amount of
the fee established under
subsection (b)(1)(D) for a
biosimilar biological product
application; minus
[(II) the cumulative amount
of fees paid, if any, under
subparagraphs (A), (B), and (D)
of paragraph (1) for that
product.
[(iii) A fee for a supplement for
which clinical data (other than
comparative bioavailability studies)
with respect to safety or effectiveness
are required, that is equal to half of
the amount of the fee established under
subsection (b)(1)(D) for a biosimilar
biological product application.
[(B) Reduction in fees.--Notwithstanding
section 404 of the Biosimilar 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.]
(A) In general.--Each person that submits, on
or after October 1, 2017, a biosimilar
biological product application shall be subject
to the following fees:
(i) A fee established under
subsection (c)(5) 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.
(ii) A fee established under
subsection (c)(5) for a biosimilar
biological product application for
which clinical data (other than
comparative bioavailability studies)
with respect to safety or effectiveness
are not required for approval. Such fee
shall be equal to half of the amount of
the fee described in clause (i).
(B) Rule of applicability; treatment of
certain previously paid fees.--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--
(i) be subject to any biosimilar
biological product application fees
that may be assessed at the time when
such biosimilar biological product
application is submitted; and
(ii) be entitled to no reduction of
such application fees based on the
amount of fees paid for that product
before October 1, 2017, under such
subparagraphs (A), (B), or (D).
(C) Payment due date.--Any fee required by
subparagraph (A) shall be due upon submission
of the application [or supplement] for which
such fee applies.
(D) Exception for previously filed
application [or supplement].--If a biosimilar
biological product application [or supplement]
was submitted by a person that paid the fee for
such application [or supplement], was accepted
for filing, and was not approved or was
withdrawn (without a waiver), the submission of
a biosimilar biological product application [or
a supplement] for the same product by the same
person (or the person's licensee, assignee, or
successor) shall not be subject to a fee under
subparagraph (A).
(E) Refund of application fee if application
refused for filing or withdrawn before
filing.--The Secretary shall refund 75 percent
of the fee paid under this paragraph for any
application [or supplement] which is refused
for filing or withdrawn without a waiver before
filing.
(F) Fees for applications previously refused
for filing or withdrawn before filing.--A
biosimilar biological product application [or
supplement] that was submitted but was refused
for filing, or was withdrawn before being
accepted or refused for filing, shall be
subject to the full fee under subparagraph (A)
upon being resubmitted or filed over protest,
unless the fee is waived under [subsection (c)]
subsection (d).
[(3) Biosimilar biological product establishment
fee.--
[(A) In general.--Except as provided in
subparagraph (E), each person that is named as
the applicant in a biosimilar biological
product application shall be assessed an annual
fee established under subsection (b)(1)(E) for
each biosimilar biological product
establishment that is listed in the approved
biosimilar biological product application as an
establishment that manufactures the biosimilar
biological product named in such application.
[(B) Assessment in fiscal years.--The
establishment fee shall be assessed in each
fiscal year for which the biosimilar biological
product named in the application is assessed a
fee under paragraph (4) unless the biosimilar
biological product establishment listed in the
application does not engage in the manufacture
of the biosimilar biological product during
such fiscal year.
[(C) Due date.--The establishment fee for a
fiscal year shall be due on the later of--
[(i) the first business day on or
after October 1 of such fiscal year; or
[(ii) the first business day after
the enactment of an appropriations Act
providing for the collection and
obligation of fees for such fiscal year
under this section.
[(D) Application to establishment.--
[(i) Each biosimilar biological
product establishment shall be assessed
only one fee per biosimilar biological
product establishment, notwithstanding
the number of biosimilar biological
products manufactured at the
establishment, subject to clause (ii).
[(ii) In the event an establishment
is listed in a biosimilar biological
product application by more than one
applicant, the establishment fee for
the fiscal year shall be divided
equally and assessed among the
applicants whose biosimilar biological
products are manufactured by the
establishment during the fiscal year
and assessed biosimilar biological
product fees under paragraph (4).
[(E) Exception for new products.--If, during
the fiscal year, an applicant initiates or
causes to be initiated the manufacture of a
biosimilar biological product at an
establishment listed in its biosimilar
biological product application--
[(i) that did not manufacture the
biosimilar biological product in the
previous fiscal year; and
[(ii) for which the full biosimilar
biological product establishment fee
has been assessed in the fiscal year at
a time before manufacture of the
biosimilar biological product was
begun,
the applicant shall not be assessed a share of
the biosimilar biological product establishment
fee for the fiscal year in which the
manufacture of the product began.]
(3) Biosimilar biological product program fee.--
(A) In general.--Each person who is named as
the applicant in a biosimilar biological
product application shall pay the annual
biosimilar biological product program fee
established for a fiscal year under subsection
(c)(5) for each biosimilar biological product
that--
(i) is identified in such a
biosimilar biological product
application approved as of October 1 of
such fiscal year; and
(ii) as of October 1 of such fiscal
year, does not appear on a list,
developed and maintained by the
Secretary, of discontinued biosimilar
biological products.
(B) Due date.--The biosimilar biological
product program fee for a fiscal year shall be
due on the later of--
(i) the first business day on or
after October 1 of each such year; or
(ii) the first business day after the
enactment of an appropriations Act
providing for the collection and
obligation of fees for such year under
this section.
(C) One fee per product per year.--The
biosimilar biological product program fee shall
be paid only once for each product for each
fiscal year.
(D) Limitation.--A person who is named as the
applicant in a biosimilar biological product
application shall not be assessed more than 5
biosimilar biological product program fees for
a fiscal year for biosimilar biological
products identified in such biosimilar
biological product application.
(4) Biosimilar biological product fee.--
(A) In general.--Each person who is named as
the applicant in a biosimilar biological
product application shall pay for each such
biosimilar biological product the annual fee
established under [subsection (b)(1)(F)]
subsection (c)(5).
(B) Due date.--The biosimilar biological
product fee for a fiscal year shall be due on
the later of--
(i) the first business day on or
after October 1 of each such year; or
(ii) the first business day after the
enactment of an appropriations Act
providing for the collection and
obligation of fees for such year under
this section.
(C) One fee per product per year.--The
biosimilar biological product fee shall be paid
only once for each product for each fiscal
year.
[(b) Fee Setting and Amounts.--
[(1) In general.--Subject to paragraph (2), the
Secretary shall, 60 days before the start of each
fiscal year that begins after September 30, 2012,
establish, for the next fiscal year, the fees under
subsection (a). Except as provided in subsection (c),
such fees shall be in the following amounts:
[(A) Initial biosimilar biological product
development fee.--The initial biosimilar
biological product development fee under
subsection (a)(1)(A) for a fiscal year shall be
equal to 10 percent of the amount established
under section 736(c)(4) for a human drug
application described in section
736(a)(1)(A)(i) for that fiscal year.
[(B) Annual biosimilar biological product
development fee.--The annual biosimilar
biological product development fee under
subsection (a)(1)(B) for a fiscal year shall be
equal to 10 percent of the amount established
under section 736(c)(4) for a human drug
application described in section
736(a)(1)(A)(i) for that fiscal year.
[(C) Reactivation fee.--The reactivation fee
under subsection (a)(1)(D) for a fiscal year
shall be equal to 20 percent of the amount of
the fee established under section 736(c)(4) for
a human drug application described in section
736(a)(1)(A)(i) for that fiscal year.
[(D) Biosimilar biological product
application fee.--The biosimilar biological
product application fee under subsection (a)(2)
for a fiscal year shall be equal to the amount
established under section 736(c)(4) for a human
drug application described in section
736(a)(1)(A)(i) for that fiscal year.
[(E) Biosimilar biological product
establishment fee.--The biosimilar biological
product establishment fee under subsection
(a)(3) for a fiscal year shall be equal to the
amount established under section 736(c)(4) for
a prescription drug establishment for that
fiscal year.
[(F) Biosimilar biological product fee.--The
biosimilar biological product fee under
subsection (a)(4) for a fiscal year shall be
equal to the amount established under section
736(c)(4) for a prescription drug product for
that fiscal year.
[(2) Limit.--The total amount of fees charged for a
fiscal year under this section may not exceed the total
amount for such fiscal year of the costs of resources
allocated for the process for the review of biosimilar
biological product applications.]
(b) Fee Revenue Amounts.--
(1) Fiscal year 2018.--For fiscal year 2018, fees
under subsection (a) shall be established to generate a
total revenue amount equal to the sum of--
(A) $45,000,000; and
(B) the dollar amount equal to the fiscal
year 2018 adjustment (as determined under
subsection (c)(4)).
(2) Subsequent fiscal years.--For each of the fiscal
years 2019 through 2022, fees under subsection (a)
shall, except as provided in subsection (c), be
established to generate a total revenue amount equal to
the sum of--
(A) the annual base revenue for the fiscal
year (as determined under paragraph (4));
(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined
under subsection (c)(1));
(C) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as
determined under subsection (c)(2)); and
(D) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if
applicable (as determined under subsection
(c)(3)).
(3) Allocation of revenue amount among fees;
limitations on fee amounts.--
(A) Allocation.--The Secretary shall
determine the percentage of the total revenue
amount for a fiscal year to be derived from,
respectively--
(i) initial and annual biosimilar
development fees and reactivation fees
under subsection (a)(1);
(ii) biosimilar biological product
application fees under subsection
(a)(2); and
(iii) biosimilar biological product
program fees under subsection (a)(3).
(B) Limitations on fee amounts.--Until the
first fiscal year for which the capacity
planning adjustment under subsection (c)(2) is
effective, the amount of any fee under
subsection (a) for a fiscal year after fiscal
year 2018 shall not exceed 125 percent of the
amount of such fee for fiscal year 2018.
(C) Biosimilar biological product development
fees.--The initial biosimilar biological
product development fee under subsection
(a)(1)(A) for a fiscal year shall be equal to
the annual biosimilar biological product
development fee under subsection (a)(1)(B) for
that fiscal year.
(D) Reactivation fee.--The reactivation fee
under subsection (a)(1)(D) for a fiscal year
shall be equal to twice the amount of the
annual biosimilar biological product
development fee under subsection (a)(1)(B) for
that fiscal year.
(4) Annual base revenue.--For purposes of paragraph
(2), the dollar amount of the annual base revenue for a
fiscal year shall be the dollar amount of the total
revenue amount for the previous fiscal year, excluding
any adjustments to such revenue amount under subsection
(c)(3).
(c) Adjustments; Annual Fee Setting.--
(1) Inflation adjustment.--
(A) In general.--For purposes of subsection
(b)(2)(B), the dollar amount of the inflation
adjustment to the annual base revenue for each
fiscal year shall be equal to the product of--
(i) such annual base revenue for the
fiscal year under subsection (b); and
(ii) the inflation adjustment
percentage under subparagraph (B).
(B) Inflation adjustment percentage.--The
inflation adjustment percentage under this
subparagraph for a fiscal year is equal to the
sum of--
(i) the average annual percent change
in the cost, per full-time equivalent
position of the Food and Drug
Administration, of all personnel
compensation and benefits paid with
respect to such positions for the first
3 years of the preceding 4 fiscal
years, multiplied by the proportion of
personnel compensation and benefits
costs to total costs of the process for
the review of biosimilar biological
product applications (as defined in
section 744G(13)) for the first 3 years
of the preceding 4 fiscal years; and
(ii) the average annual percent
change that occurred in the Consumer
Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not
Seasonally Adjusted; All items; Annual
Index) for the first 3 years of the
preceding 4 years of available data
multiplied by the proportion of all
costs other than personnel compensation
and benefits costs to total costs of
the process for the review of
biosimilar biological product
applications (as defined in section
744G(13)) for the first 3 years of the
preceding 4 fiscal years.
(2) Capacity planning adjustment.--
(A) In general.--Beginning with the fiscal
year described in subparagraph (B)(ii)(II), the
Secretary shall, in addition to the adjustment
under paragraph (1), further increase the fee
revenue and fees under this section for a
fiscal year to reflect changes in the resource
capacity needs of the Secretary for the process
for the review of biosimilar biological product
applications.
(B) Capacity planning methodology.--
(i) Development; evaluation and
report.--The Secretary shall obtain,
through a contract with an independent
accounting or consulting firm, a report
evaluating options and recommendations
for a new methodology to accurately
assess changes in the resource and
capacity needs of the process for the
review of biosimilar biological product
applications. The capacity planning
methodological options and
recommendations presented in such
report shall utilize and be informed by
personnel time reporting data as an
input. The report shall be published
for public comment not later than
September 30, 2020.
(ii) Establishment and
implementation.--After review of the
report described in clause (i) and
receipt and review of public comments
thereon, the Secretary shall establish
a capacity planning methodology for
purposes of this paragraph, which
shall--
(I) incorporate such
approaches and attributes as
the Secretary determines
appropriate; and
(II) be effective beginning
with the first fiscal year for
which fees are set after such
capacity planning methodology
is established.
(C) Limitation.--Under no circumstances shall
an adjustment under this paragraph result in
fee revenue for a fiscal year that is less than
the sum of the amounts under subsections
(b)(2)(A) (the annual base revenue for the
fiscal year) and (b)(2)(B) (the dollar amount
of the inflation adjustment for the fiscal
year).
(D) Publication in federal register.--The
Secretary shall publish in the Federal Register
notice under paragraph (5) the fee revenue and
fees resulting from the adjustment and the
methodologies under this paragraph.
(3) Operating reserve adjustment.--
(A) Interim application; fee reduction.--
Until the first fiscal year for which the
capacity planning adjustment under paragraph
(2) is effective, the Secretary may, in
addition to the adjustment under paragraph (1),
reduce the fee revenue and fees under this
section for a fiscal year as the Secretary
determines appropriate for long-term financial
planning purposes.
(B) General application and methodology.--
Beginning with the first fiscal year for which
the capacity planning adjustment under
paragraph (2) is effective, the Secretary may,
in addition to the adjustments under paragraphs
(1) and (2)--
(i) reduce the fee revenue and fees
under this section as the Secretary
determines appropriate for long-term
financial planning purposes; or
(ii) increase the fee revenue and
fees under this section if such an
adjustment is necessary to provide for
not more than 21 weeks of operating
reserves of carryover user fees for the
process for the review of biosimilar
biological product applications.
(C) Federal register notice.--If an
adjustment under subparagraph (A) or (B) is
made, the rationale for the amount of the
increase or decrease (as applicable) in fee
revenue and fees shall be contained in the
annual Federal Register notice under paragraph
(5) establishing fee revenue and fees for the
fiscal year involved.
(4) Fiscal year 2018 adjustment.--
(A) In general.--For fiscal year 2018, the
Secretary shall adjust the fee revenue and fees
under this section in such amount (if any) as
needed to reflect an updated assessment of the
workload for the process for the review of
biosimilar biological product applications.
(B) Methodology.--The Secretary shall publish
under paragraph (5) a description of the
methodology used to calculate the fiscal year
2018 adjustment under this paragraph in the
Federal Register notice establishing fee
revenue and fees for fiscal year 2018.
(C) Limitation.--No adjustment under this
paragraph shall result in an increase in fee
revenue and fees under this section in excess
of $9,000,000.
(5) Annual fee setting.--For fiscal year 2018 and
each subsequent fiscal year, the Secretary shall, not
later than 60 days before the start of each such fiscal
year--
(A) establish, for the fiscal year, initial
and annual biosimilar biological product
development fees and reactivation fees under
subsection (a)(1), biosimilar biological
product application fees under subsection
(a)(2), and biosimilar biological product
program fees under subsection (a)(3), based on
the revenue amounts established under
subsection (b) and the adjustments provided
under this subsection; and
(B) publish such fee revenue and fees in the
Federal Register.
(6) Limit.--The total amount of fees assessed for a
fiscal year under this section may not exceed the total
costs for such fiscal year for the resources allocated
for the process for the review of biosimilar biological
product applications.
[(c)] (d) Application Fee Waiver for Small Business.--
(1) Waiver of application fee.--The Secretary shall
grant to a person who is named in a biosimilar
biological product application a waiver from the
application fee assessed to that person under
subsection (a)(2)(A) for the first biosimilar
biological product application that a small business or
its affiliate submits to the Secretary for review.
After a small business or its affiliate is granted such
a waiver, the small business or its affiliate [shall
pay--]
[(A)] [application fees] shall pay
application fees for all subsequent biosimilar
biological product applications submitted to
the Secretary for review in the same manner as
an entity that is not a small business[; and].
[(B) all supplement fees for all supplements
to biosimilar biological product applications
submitted to the Secretary for review in the
same manner as an entity that is not a small
business.]
(2) Considerations.--In determining whether to grant
a waiver of a fee under paragraph (1), the Secretary
shall consider only the circumstances and assets of the
applicant involved and any affiliate of the applicant.
(3) Small business defined.--In this subsection, the
term ``small business'' means an entity that has fewer
than 500 employees, including employees of affiliates,
and does not have a drug product that has been approved
under a human drug application (as defined in section
735) or a biosimilar biological product application (as
defined in section 744G(4)) and introduced or delivered
for introduction into interstate commerce.
[(d)] (e) Effect of Failure To Pay Fees.--A biosimilar
biological product application or supplement submitted by a
person subject to fees under subsection (a) shall be considered
incomplete and shall not be accepted for filing by the
Secretary until [all fees] all such fees owed by such person
have been paid.
[(e)] (f) Crediting and Availability of Fees.--
(1) In general.--Subject to paragraph (2), fees
authorized under subsection (a) shall be collected and
available for obligation only to the extent and in the
amount provided in advance in appropriations Acts. Such
fees are authorized to remain available until expended.
Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to
such appropriation account for salaries and expenses
with such fiscal year limitation. The sums transferred
shall be available solely for the process for the
review of biosimilar biological product applications.
(2) Collections and appropriation acts.--
(A) In general.--Subject to subparagraphs (C)
and (D), the fees authorized by this section
shall be collected and available in each fiscal
year in an amount not to exceed the amount
specified in appropriation Acts, or otherwise
made available for obligation for such fiscal
year.
(B) Use of fees and limitation.--The fees
authorized by this section shall be available
for a fiscal year beginning after fiscal year
2012 to defray the costs of the process for the
review of biosimilar biological product
applications (including such costs for an
additional number of full-time equivalent
positions in the Department of Health and Human
Services to be engaged in such process), only
if the Secretary allocates for such purpose an
amount for such fiscal year (excluding amounts
from fees collected under this section) no less
than $20,000,000, multiplied by the adjustment
factor applicable to the fiscal year involved.
[(C) Fee collection during first program
year.--Until the date of enactment of an Act
making appropriations through September 30,
2013, for the salaries and expenses account of
the Food and Drug Administration, fees
authorized by this section for fiscal year 2013
may be collected and shall be credited to such
account and remain available until expended.]
(C) Compliance.--The Secretary shall be
considered to have met the requirements of
subparagraph (B) in any fiscal year if the
costs described in such subparagraph are not
more than 15 percent below the level specified
in such subparagraph.
(D) Provision for early payments [in
subsequent years].--Payment of fees authorized
under this section for a fiscal year [(after
fiscal year 2013)], prior to the due date for
such fees, may be accepted by the Secretary in
accordance with authority provided in advance
in a prior year appropriations Act.
(3) Authorization of appropriations.--For each of
fiscal years [2013 through 2017] 2018 through 2022,
there is authorized to be appropriated for fees under
this section an amount equivalent to the total amount
of fees assessed for such fiscal year under this
section.
[(f)] (g) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States Code.
[(g)] (h) Written Requests for Waivers and Refunds.--To
qualify for consideration for a waiver under [subsection (c)]
subsection (d), or for a refund of any fee collected in
accordance with subsection (a)(2)(A), a person shall submit to
the Secretary a written request for such waiver or refund not
later than 180 days after such fee is due.
[(h)] (i) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employers, and advisory committees not engaged in the process
of the review of biosimilar biological product applications, be
reduced to offset the number of officers, employees, and
advisory committees so engaged.
SEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Report.--Beginning with fiscal year [2013]
2018, not later than 120 days after the end of each fiscal year
for which fees are collected under this part, the Secretary
shall prepare and submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a report
concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in
section 401(b) of the [Biosimilar User Fee Act of 2012]
Biosimilar User Fee Amendments of 2017 during such fiscal year
and the future plans of the Food and Drug Administration for
meeting such goals. The report for a fiscal year shall include
information on all previous cohorts for which the Secretary has
not given a complete response on all biosimilar biological
product applications and supplements in the cohort.
(b) Fiscal Report.--Not later than 120 days after the end of
fiscal year [2013] 2018 and each subsequent fiscal year for
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected for such fiscal year.
(c) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to the
public on the Internet Web site of the Food and Drug
Administration.
[(d) Study.--
[(1) In general.--The Secretary shall contract with
an independent accounting or consulting firm to study
the workload volume and full costs associated with the
process for the review of biosimilar biological product
applications.
[(2) Interim results.--Not later than June 1, 2015,
the Secretary shall publish, for public comment,
interim results of the study described under paragraph
(1).
[(3) Final results.--Not later than September 30,
2016, the Secretary shall publish, for public comment,
the final results of the study described under
paragraph (1).]
[(e)] (d) Reauthorization.--
(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals
described in subsection (a), and plans for meeting the
goals, for the process for the review of biosimilar
biological product applications for the first 5 fiscal
years after fiscal year [2017] 2022, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
(A) the Committee on Energy and Commerce of
the House of Representatives;
(B) the Committee on Health, Education,
Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer
advocacy groups; and
(F) the regulated industry.
(2) Public review of recommendations.--After
negotiations with the regulated industry, the Secretary
shall--
(A) present the recommendations developed
under paragraph (1) to the congressional
committees specified in such paragraph;
(B) publish such recommendations in the
Federal Register;
(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
(D) hold a meeting at which the public may
present its views on such recommendations; and
(E) after consideration of such public views
and comments, revise such recommendations as
necessary.
(3) Transmittal of recommendations.--Not later than
January 15, [2017] 2022, 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.
* * * * * * *
Subchapter D--Information and Education
* * * * * * *
SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS.
(a) Drugs and Biologics.--
(1) In general.--Beginning no earlier than 24 months
after the issuance of a final guidance issued after
public notice and opportunity for comment, submissions
under subsection (b), (i), or (j) of section 505 of
this Act or subsection (a) or (k) of section 351 of the
Public Health Service Act shall be submitted in such
electronic format as specified by the Secretary in such
guidance.
(2) Guidance contents.--In the guidance under
paragraph (1), the Secretary may--
(A) provide a timetable for establishment by
the Secretary of further standards for
electronic submission as required by such
paragraph; and
(B) set forth criteria for waivers of and
exemptions from the requirements of this
subsection.
(3) Exception.--This subsection shall not apply to
submissions described in section 561.
(b) Devices.--
(1) In general.--Beginning after the issuance of
final guidance implementing this paragraph,
presubmissions and submissions for devices under
section 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f),
520(g), 520(m), or 564 of this Act or section 351 of
the Public Health Service Act, and any supplements to
such presubmissions or submissions, shall include an
electronic copy of such presubmissions or submissions.
(2) Guidance contents.--In the guidance under
paragraph (1), the Secretary may--
(A) provide standards for the electronic copy
required under such paragraph; and
(B) set forth criteria for waivers of and
exemptions from the requirements of this
subsection.
(3) Presubmissions and submissions solely in
electronic format.--
(A) In general.--Beginning on such date as
the Secretary specifies in final guidance
issued under subparagraph (C), presubmissions
and submissions for devices described in
paragraph (1) (and any appeals of action taken
by the Secretary with respect to such
presubmissions or submissions) shall be
submitted solely in such electronic format as
specified by the Secretary in such guidance.
(B) Draft guidance.--The Secretary shall, not
later than October 1, 2019, issue draft
guidance providing for--
(i) any further standards for the
submission by electronic format
required under subparagraph (A);
(ii) a timetable for the
establishment by the Secretary of such
further standards; and
(iii) criteria for waivers of and
exemptions from the requirements of
this subsection.
(C) Final guidance.--The Secretary shall, not
later than 12 months after the close of the
public comment period on the draft guidance
issued under subparagraph (B), issue final
guidance described in clauses (i) through (iii)
of such subparagraph.
* * * * * * *
CHAPTER VIII--IMPORTS AND EXPORTS
imports and exports
Sec. 801. (a) The Secretary of the Treasury shall deliver to
the Secretary of Health and Human Services, upon his request,
samples of food, drugs, devices, tobacco products, and
cosmetics which are being imported or offered for import into
the United States, giving notice thereof to the owner or
consignee, who may appear before the Secretary of Health and
Human Services and have the right to introduce testimony. The
Secretary of Health and Human Services shall furnish to the
Secretary of the Treasury a list of establishments registered
pursuant to subsection (i) of section 510 or section 905(h) and
shall request that if any drugs, devices, or tobacco products
manufactured, prepared, propagated, compounded, or processed in
an establishment not so registered are imported or offered for
import into the United States, samples of such drugs, devices,
or tobacco products be delivered to the Secretary of Health and
Human Services, with notice of such delivery to the owner or
consignee, who may appear before the Secretary of Health and
Human Services and have the right to introduce testimony. If it
appears from the examination of such samples or otherwise that
(1) such article has been manufactured, processed, or packed
under insanitary conditions or, in the case of a device, the
methods used in, or the facilities or controls used for, the
manufacture, packing, storage, or installation of the device do
not conform to the requirements of section 520(f), or (2) such
article is forbidden or restricted in sale in the country in
which it was produced or from which it was exported, or (3)
such article is adulterated, misbranded, or in violation of
section 505 or the importer (as defined in section 805) is in
violation of such section 805, or prohibited from introduction
or delivery for introduction into interstate commerce under
section 301(ll), or (4) the recordkeeping requirements under
section 204 of the FDA Food Safety Modernization Act (other
than the requirements under subsection (f) of such section)
have not been complied with regarding such article, then such
article shall be refused admission, except as provided in
subsection (b) of this section. With respect to an article of
food, if importation of such food is subject to, but not
compliant with, the requirement under subsection (q) that such
food be accompanied by a certification or other assurance that
the food meets applicable requirements of this Act, then such
article shall be refused admission. If such article is subject
to a requirement under section 760 or 761 and if the Secretary
has credible evidence or information indicating that the
responsible person (as defined in such section 760 or 761) has
not complied with a requirement of such section 760 or 761 with
respect to any such article, or has not allowed access to
records described in such section 760 or 761, then such article
shall be refused admission, except as provided in subsection
(b) of this section. The Secretary of the Treasury shall cause
the destruction of any such article refused admission unless
such article is exported, under regulations prescribed by the
Secretary of the Treasury, within ninety days of the date of
notice of such refusal or within such additional time as may be
permitted pursuant to such regulations, 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).. 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. Clause (2) of the third sentence of this
paragraph shall not be construed to prohibit the admission of
narcotic drugs the importation of which is permitted under the
Controlled Substances Import and Export Act.
(b) Pending decision as to the admission of an article being
imported or offered for import, the Secretary of the Treasury
may authorize delivery of such article to the owner or
consignee upon the execution by him of a good and sufficient
bond providing for the payment of such liquidated damages in
the event of default as may be required pursuant to regulations
of the Secretary of the Treasury. If it appears to the
Secretary of Health and Human Services that (1) an article
included within the provisions of clause (3) of subsection (a)
of this section can, by relabeling or other action, be brought
into compliance with the Act or rendered other than a food,
drug, device, or cosmetic, or (2) with respect to an article
described in subsection (a) relating to the requirements of
sections 760 or 761,, the responsible person (as defined in
section 760 or 761) can take action that would assure that the
responsible person is in compliance with section 760 or 761, as
the case may be, final determination as to admission of such
article may be deferred and, upon filing of timely written
application by the owner or consignee and the execution by him
of a bond as provided in the preceding provisions of this
subsection, the Secretary may, in accordance with regulations,
authorize the applicant, or, with respect to clause (2), the
responsible person, to perform such relabeling or other action
specified in such authorization (including destruction or
export of rejected articles or portions thereof, as may be
specified in the Secretary's authorization). All such
relabeling or other action pursuant to such authorization shall
in accordance with regulations be under the supervision of an
officer or employee of the Department of Health and Human
Services designated by the Secretary, or an officer or employee
of the Department of the Treasury designated by the Secretary
of the Treasury.
(c) All expenses (including travel, per diem or subsistence,
and salaries of officers or employees of the United States) in
connection with the destruction provided for in subsection (a)
of this section and the supervision of the relabeling or other
action authorized under the provisions of subsection (b) of
this section, the amount of such expenses to be determined in
accordance with regulations, and all expenses in connection
with the storage, cartage, or labor with respect to any article
refused admission under subsection (a) of this section, shall
be paid by the owner or consignee and, in default of such
payment, shall constitute a lien against any future
importations made by such owner or consignee.
(d)[(1)] [Except as] (1)(A) Except as provided in paragraph
(2) and section 804, no drug subject to section 503(b) or
composed wholly or partly of insulin which is manufactured in a
State and exported may be imported into the United States
unless the drug is imported by the manufacturer of the drug.
(B) Except as authorized by the Secretary in the case of a
drug that appears on the drug shortage list in effect under
section 506E, no drug that would be subject to section 503(b),
and which is manufactured outside the United States and
intended by the manufacturer or labeled to be marketed outside
the United States, may be imported into the United States for
sale or commercial use.
(2) The Secretary may authorize the importation of a drug the
importation of which is prohibited by paragraph (1) if the drug
is required for emergency medical care.
(3)(A) Subject to subparagraph (B), no component of a drug,
no component part or accessory of a device, or other article of
device requiring further processing, which is ready or suitable
for use for health-related purposes, and no article of a food
additive, color additive, or dietary supplement, including a
product in bulk form, shall be excluded from importation into
the United States under subsection (a) if each of the following
conditions is met:
(i) The importer of such article of a drug or device
or importer of such article of a food additive, color
additive, or dietary supplement submits to the
Secretary, at the time of initial importation, a
statement in accordance with the following:
(I) Such statement provides that such article
is intended to be further processed by the
initial owner or consignee, or incorporated by
the initial owner or consignee, into a drug,
biological product, device, food, food
additive, color additive, or dietary supplement
that will be exported by the initial owner or
consignee from the United States in accordance
with subsection (e) or section 802, or with
section 351(h) of the Public Health Service
Act.
(II) The statement identifies the
manufacturer of such article and each
processor, packer, distributor, or other entity
that had possession of the article in the chain
of possession of the article from the
manufacturer to such importer of the article.
(III) The statement is accompanied by such
certificates of analysis as are necessary to
identify such article, unless the article is a
device or is an article described in paragraph
(4).
(ii) At the time of initial importation and before
the delivery of such article to the importer or the
initial owner or consignee, such owner or consignee
executes a good and sufficient bond providing for the
payment of such liquidated damages in the event of
default as may be required pursuant to regulations of
the Secretary of the Treasury.
(iii) Such article is used and exported by the
initial owner or consignee in accordance with the
intent described under clause (i)(I), except for any
portions of the article that are destroyed.
(iv) The initial owner or consignee maintains records
on the use or destruction of such article or portions
thereof, as the case may be, and submits to the
Secretary any such records requested by the Secretary.
(v) Upon request of the Secretary, the initial owner
or consignee submits a report that provides an
accounting of the exportation or destruction of such
article or portions thereof, and the manner in which
such owner or consignee complied with the requirements
of this subparagraph.
(B) Notwithstanding subparagraph (A), the Secretary may
refuse admission to an article that otherwise would be imported
into the United States under such subparagraph if the Secretary
determines that there is credible evidence or information
indicating that such article is not intended to be further
processed by the initial owner or consignee, or incorporated by
the initial owner or consignee, into a drug, biological
product, device, food, food additive, color additive, or
dietary supplement that will be exported by the initial owner
or consignee from the United States in accordance with
subsection (e) or section 802, or with section 351(h) of the
Public Health Service Act.
(C) This section may not be construed as affecting the
responsibility of the Secretary to ensure that articles
imported into the United States under authority of subparagraph
(A) meet each of the conditions established in such
subparagraph for importation.
(4) The importation into the United States of blood, blood
components, source plasma, or source leukocytes or of a
component, accessory, or part thereof is not permitted pursuant
to paragraph (3) unless the importation complies with section
351(a) of the Public Health Service Act or the Secretary
permits the importation under appropriate circumstances and
conditions, as determined by the Secretary. The importation of
tissue or a component or part of tissue is not permitted
pursuant to paragraph (3) unless the importation complies with
section 361 of the Public Health Service Act.
(e)(1) A food, drug, device, tobacco product or cosmetic
intended for export shall not be deemed to be adulterated or
misbranded under this Act, and a tobacco product intended for
export shall not be deemed to be in violation of section
906(e), 907, 911, or 920(a), if it--
(A) accords to the specifications of the foreign
purchaser,
(B) is not in conflict with the laws of the country
to which it is intended for export,
(C) is labeled on the outside of the shipping package
that it is intended for export, and
(D) is not sold or offered for sale in domestic
commerce.
(2) Paragraph (1) does not apply to any device--
(A) which does not comply with an applicable
requirement of section 514 or 515,
(B) which under section 520(g) is exempt from either
such section, or
(C) which is a banned device under section 516,
unless, in addition to the requirements of paragraph (1),
either (i) the Secretary has determined that the exportation of
the device is not contrary to public health and safety and has
the approval of the country to which it is intended for export
or (ii) the device is eligible for export under section 802.
(3) A new animal drug that requires approval under section
512 shall not be exported pursuant to paragraph (1) if such
drug has been banned in the United States.
(4)(A) Any person who exports a food, drug, animal drug, or
device may request that the Secretary--
(i) certify in writing that the exported food, drug,
animal drug, or device meets the requirements of
paragraph (1) or section 802; or
(ii) certify in writing that the food, drug, animal
drug, or device being exported meets the applicable
requirements of this Act upon a showing that the food,
drug or device meets the applicable requirements of
this Act.
The Secretary shall issue such a certification within 20 days
of the receipt of a request for such certification.
(B) If the Secretary issues a written export certification
within the 20 days prescribed by subparagraph (A), a fee for
such certification may be charged but shall not exceed $175 for
each certification. Fees collected for a fiscal year pursuant
to this subparagraph shall be credited to the appropriation
account for salaries and expenses of the Food and Drug
Administration and shall be available in accordance with
appropriations Acts until expended without fiscal year
limitation. Such fees shall be collected in each fiscal year in
an amount equal to the amount specified in appropriations Acts
for such fiscal year and shall only be collected and available
for the costs of the Food and Drug Administration.
(C) For purposes of this paragraph, a certification by the
Secretary shall be made on such basis, and in such form
(including a publicly available listing) as the Secretary
determines appropriate.
(D) With regard to fees pursuant to subparagraph (B) in
connection with written export certifications for food:
(i) Such fees shall be collected and available solely
for the costs of the Food and Drug Administration
associated with issuing such certifications.
(ii) Such fees may not be retained in an amount that
exceeds such costs for the respective fiscal year.
(E)(i) If the Secretary denies a request made under
subparagraph (A)(ii) for certification with respect to a
device, the Secretary shall provide, in writing, to the person
seeking such certification the basis for such denial, and
specifically identify the finding upon which such denial is
based.
(ii) If the denial of a request as described in clause (i) is
based on--
(I) grounds other than an injunction proceeding
pursuant to section 302, seizure action pursuant to
section 304, or a recall designated Class I or Class II
pursuant to part 7, title 21, Code of Federal
Regulations, and
(II) an establishment being considered out of
compliance with part 820, title 21, Code of Federal
Regulations,
the Secretary shall provide a substantive summary of the
specific grounds for noncompliance so identified, if such
grounds have not been previously communicated to the
manufacturer.
(iii) With respect to a device manufactured in an
establishment that has received a report under section 704(b),
the Secretary shall not deny a request for certification under
subparagraph (A)(ii) based exclusively on the issuance of that
report if the owner, operator, or agent in charge of such
establishment has agreed to a plan of correction in response to
such report.
(F)(i) The Secretary shall provide a process for a person who
is denied a certification as described in subparagraph (E)(i)
to request a review that conforms to the standards of section
517A(b).
(ii) Notwithstanding any previous review conducted pursuant
to clause (i), a person who has been denied a certification for
a device as described in subparagraph (E)(i) may, at any time,
request a review of that denial in order to present new
information relating to actions taken by such person to address
the reasons identified by the Secretary for such denial,
including evidence that corrective actions are being or have
been implemented to address the grounds for noncompliance
identified by the Secretary under subparagraph (E)(ii).
(G)(i) This paragraph applies to requests for certification
on behalf of any device establishment registered under section
510, whether the establishment is located in the United States
or another country.
(ii) The Secretary may charge a fee for the issuance of a
certification described in clause (i), and such fee is subject
to the same conditions and requirements as a fee charged under
subparagraph (B) for a certification issued under such
subparagraph.
(f)(1) If a drug (other than insulin, an antibiotic drug, an
animal drug, or a drug exported under section 802) being
exported in accordance with subsection (e) is being exported to
a country that has different or additional labeling
requirements or conditions for use and such country requires
the drug to be labeled in accordance with those requirements or
uses, such drug may be labeled in accordance with such
requirements and conditions for use in the country to which
such drug is being exported if it also is labeled in accordance
with the requirements of this Act.
(2) If, pursuant to paragraph (1), the labeling of an
exported drug includes conditions for use that have not been
approved under this Act, the labeling must state that such
conditions for use have not been approved under this Act. A
drug exported under section 802 is exempt from this section.
(g)(1) With respect to a prescription drug being imported or
offered for import into the United States, the Secretary, in
the case of an individual who is not in the business of such
importations, may not send a warning notice to the individual
unless the following conditions are met:
(A) The notice specifies, as applicable to the
importation of the drug, that the Secretary has made a
determination that--
(i) importation is in violation of section
801(a) because the drug is or appears to be
adulterated, misbranded, or in violation of
section 505;
(ii) importation is in violation of section
801(a) because the drug is or appears to be
forbidden or restricted in sale in the country
in which it was produced or from which it was
exported;
(iii) importation is or appears to be in
violation of section 801(d)(1); or
(iv) importation otherwise is or appears to
be in violation of Federal law.
(B) The notice does not specify any provision
described in subparagraph (A) that is not applicable to
the importation of the drug.
(C) The notice states the reasons underlying such
determination by the Secretary, including a brief
application to the principal facts involved of the
provision of law described in subparagraph (A) that is
the basis of the determination by the Secretary.
(2) For purposes of this section, the term ``warning
notice'', with respect to the importation of a drug, means a
communication from the Secretary (written or otherwise)
notifying a person, or clearly suggesting to the person, that
importing the drug for personal use is, or appears to be, a
violation of this Act.
(h)(1) The Secretary shall give high priority to increasing
the number of inspections under this section for the purpose of
enabling the Secretary to inspect food offered for import at
ports of entry into the United States, with the greatest
priority given to inspections to detect the intentional
adulteration of food.
(2) The Secretary shall give high priority to making
necessary improvements to the information management systems of
the Food and Drug Administration that contain information
related to foods imported or offered for import into the United
States for purposes of improving the ability of the Secretary
to allocate resources, detect the intentional adulteration of
food, and facilitate the importation of food that is in
compliance with this Act.
(3) The Secretary shall improve linkages with other
regulatory agencies of the Federal Government that share
responsibility for food safety, and shall with respect to such
safety improve linkages with the States and Indian tribes (as
defined in section 4(e) of the Indian Self-Determination and
Education Assistance Act (25 U.S.C. 450b(e))).
(i)(1) For use in inspections of food under this section, the
Secretary shall provide for research on the development of
tests and sampling methodologies--
(A) whose purpose is to test food in order to rapidly
detect the adulteration of the food, with the greatest
priority given to detect the intentional adulteration
of food; and
(B) whose results offer significant improvements over
the available technology in terms of accuracy, timing,
or costs.
(2) In providing for research under paragraph (1), the
Secretary shall give priority to conducting research on the
development of tests that are suitable for inspections of food
at ports of entry into the United States.
(3) In providing for research under paragraph (1), the
Secretary shall as appropriate coordinate with the Director of
the Centers for Disease Control and Prevention, the Director of
the National Institutes of Health, the Administrator of the
Environmental Protection Agency, and the Secretary of
Agriculture.
(4) The Secretary shall annually 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 describing the progress made in research under
paragraph (1), including progress regarding paragraph (2).
(j)(1) If an officer or qualified employee of the Food and
Drug Administration has credible evidence or information
indicating that an article of food presents a threat of serious
adverse health consequences or death to humans or animals, and
such officer or qualified employee is unable to inspect,
examine, or investigate such article upon the article being
offered for import at a port of entry into the United States,
the officer or qualified employee shall request the Secretary
of Treasury to hold the food at the port of entry for a
reasonable period of time, not to exceed 24 hours, for the
purpose of enabling the Secretary to inspect, examine, or
investigate the article as appropriate.
(2) The Secretary shall request the Secretary of Treasury to
remove an article held pursuant to paragraph (1) to a secure
facility, as appropriate. During the period of time that such
article is so held, the article shall not be transferred by any
person from the port of entry into the United States for the
article, or from the secure facility to which the article has
been removed, as the case may be. Subsection (b) does not
authorize the delivery of the article pursuant to the execution
of a bond while the article is so held.
(3) An officer or qualified employee of the Food and Drug
Administration may make a request under paragraph (1) only if
the Secretary or an official designated by the Secretary
approves the request. An official may not be so designated
unless the official is the director of the district under this
Act in which the article involved is located, or is an official
senior to such director.
(4) With respect to an article of food for which a request
under paragraph (1) is made, the Secretary, promptly after the
request is made, shall notify the State in which the port of
entry involved is located that the request has been made, and
as applicable, that such article is being held under this
subsection.
(k)(1) If an article of food is being imported or offered for
import into the United States, and the importer, owner, or
consignee of the article is a person who has been debarred
under section 306(b)(3), such article shall be held at the port
of entry for the article, and may not be delivered to such
person. Subsection (b) does not authorize the delivery of the
article pursuant to the execution of a bond while the article
is so held. The article shall be removed to a secure facility,
as appropriate. During the period of time that such article is
so held, the article shall not be transferred by any person
from the port of entry into the United States for the article,
or from the secure facility to which the article has been
removed, as the case may be.
(2) An article of food held under paragraph (1) may be
delivered to a person who is not a debarred person under
section 306(b)(3) if such person affirmatively establishes, at
the expense of the person, that the article complies with the
requirements of this Act, as determined by the Secretary.
(l)(1) If an article of food is being imported or offered for
import into the United States, and such article is from a
foreign facility for which a registration has not been
submitted to the Secretary under section 415 (or for which a
registration has been suspended under such section), such
article shall be held at the port of entry for the article, and
may not be delivered to the importer, owner, or consignee of
the article, until the foreign facility is so registered.
Subsection (b) does not authorize the delivery of the article
pursuant to the execution of a bond while the article is so
held. The article shall be removed to a secure facility, as
appropriate. During the period of time that such article is so
held, the article shall not be transferred by any person from
the port of entry into the United States for the article, or
from the secure facility to which the article has been removed,
as the case may be.
(m)(1) In the case of an article of food that is being
imported or offered for import into the United States, the
Secretary, after consultation with the Secretary of the
Treasury, shall by regulation require, for the purpose of
enabling such article to be inspected at ports of entry into
the United States, the submission to the Secretary of a notice
providing the identity of each of the following: The article;
the manufacturer and shipper of the article; if known within
the specified period of time that notice is required to be
provided, the grower of the article; the country from which the
article originates; the country from which the article is
shipped; any country to which the article has been refused
entry; and the anticipated port of entry for the article. An
article of food imported or offered for import without
submission of such notice in accordance with the requirements
under this paragraph shall be refused admission into the United
States. Nothing in this section may be construed as a
limitation on the port of entry for an article of food.
(2)(A) Regulations under paragraph (1) shall require that a
notice under such paragraph be provided by a specified period
of time in advance of the time of the importation of the
article of food involved or the offering of the food for
import, which period shall be no less than the minimum amount
of time necessary for the Secretary to receive, review, and
appropriately respond to such notification, but may not exceed
five days. In determining the specified period of time required
under this subparagraph, the Secretary may consider, but is not
limited to consideration of, the effect on commerce of such
period of time, the locations of the various ports of entry
into the United States, the various modes of transportation,
the types of food imported into the United States, and any
other such consideration. Nothing in the preceding sentence may
be construed as a limitation on the obligation of the Secretary
to receive, review, and appropriately respond to any notice
under paragraph (1).
(B)(i) If an article of food is being imported or offered for
import into the United States and a notice under paragraph (1)
is not provided in advance in accordance with the requirements
under paragraph (1), such article shall be held at the port of
entry for the article, and may not be delivered to the
importer, owner, or consignee of the article, until such notice
is submitted to the Secretary, and the Secretary examines the
notice and determines that the notice is in accordance with the
requirements under paragraph (1). Subsection (b) does not
authorize the delivery of the article pursuant to the execution
of a bond while the article is so held. The article shall be
removed to a secure facility, as appropriate. During the period
of time that such article is so held, the article shall not be
transferred by any person from the port of entry into the
United States for the article, or from the secure facility to
which the article has been removed, as the case may be.
(ii) In carrying out clause (i) with respect to an article of
food, the Secretary shall determine whether there is in the
possession of the Secretary any credible evidence or
information indicating that such article presents a threat of
serious adverse health consequences or death to humans or
animals.
(3)(A) This subsection may not be construed as limiting the
authority of the Secretary to obtain information under any
other provision of this Act.
(B) This subsection may not be construed as authorizing the
Secretary to impose any requirements with respect to a food to
the extent that it is within the exclusive jurisdiction of the
Secretary of Agriculture pursuant to the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products
Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products
Inspection Act (21 U.S.C. 1031 et seq.).
(n)(1) If a food has been refused admission under subsection
(a), other than such a food that is required to be destroyed,
the Secretary may require the owner or consignee of the food to
affix to the container of the food a label that clearly and
conspicuously bears the statement: ``UNITED STATES: REFUSED
ENTRY''.
(2) All expenses in connection with affixing a label under
paragraph (1) shall be paid by the owner or consignee of the
food involved, and in default of such payment, shall constitute
a lien against future importations made by such owner or
consignee.
(3) A requirement under paragraph (1) remains in effect until
the Secretary determines that the food involved has been
brought into compliance with this Act.
(o) If an article that is a device is being imported or
offered for import into the United States, and the importer,
owner, or consignee of such article does not, at the time of
offering the article for import, submit to the Secretary a
statement that identifies the registration under section 510(i)
of each establishment that with respect to such article is
required under such section to register with the Secretary, the
article may be refused admission. If the article is refused
admission for failure to submit such a statement, the article
shall be held at the port of entry for the article, and may not
be delivered to the importer, owner, or consignee of the
article, until such a statement is submitted to the Secretary.
Subsection (b) does not authorize the delivery of the article
pursuant to the execution of a bond while the article is so
held. The article shall be removed to a secure facility, as
appropriate. During the period of time that such article is so
held, the article shall not be transferred by any person from
the port of entry into the United States for the article, or
from the secure facility to which the article has been removed,
as the case may be.
(p)(1) Not later than 36 months after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act, and
annually thereafter, the Secretary 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 regarding--
(A) the nature, extent, and destination of United
States tobacco product exports that do not conform to
tobacco product standards established pursuant to this
Act;
(B) the public health implications of such exports,
including any evidence of a negative public health
impact; and
(C) recommendations or assessments of policy
alternatives available to Congress and the executive
branch to reduce any negative public health impact
caused by such exports.
(2) The Secretary is authorized to establish appropriate
information disclosure requirements to carry out this
subsection.
(q) Certifications Concerning Imported Foods.--
(1) In general.--The Secretary may require, as a
condition of granting admission to an article of food
imported or offered for import into the United States,
that an entity described in paragraph (3) provide a
certification, or such other assurances as the
Secretary determines appropriate, that the article of
food complies with applicable requirements of this Act.
Such certification or assurances may be provided in the
form of shipment-specific certificates, a listing of
certified facilities that manufacture, process, pack,
or hold such food, or in such other form as the
Secretary may specify.
(2) Factors to be considered in requiring
certification.--The Secretary shall base the
determination that an article of food is required to
have a certification described in paragraph (1) on the
risk of the food, including--
(A) known safety risks associated with the
food;
(B) known food safety risks associated with
the country, territory, or region of origin of
the food;
(C) a finding by the Secretary, supported by
scientific, risk-based evidence, that--
(i) the food safety programs,
systems, and standards in the country,
territory, or region of origin of the
food are inadequate to ensure that the
article of food is as safe as a similar
article of food that is manufactured,
processed, packed, or held in the
United States in accordance with the
requirements of this Act; and
(ii) the certification would assist
the Secretary in determining whether to
refuse or admit the article of food
under subsection (a); and
(D) information submitted to the Secretary in
accordance with the process established in
paragraph (7).
(3) Certifying entities.--For purposes of paragraph
(1), entities that shall provide the certification or
assurances described in such paragraph are--
(A) an agency or a representative of the
government of the country from which the
article of food at issue originated, as
designated by the Secretary; or
(B) such other persons or entities accredited
pursuant to section 808 to provide such
certification or assurance.
(4) Renewal and refusal of certifications.--The
Secretary may--
(A) require that any certification or other
assurance provided by an entity specified in
paragraph (2) be renewed by such entity at such
times as the Secretary determines appropriate;
and
(B) refuse to accept any certification or
assurance if the Secretary determines that such
certification or assurance is not valid or
reliable.
(5) Electronic submission.--The Secretary shall
provide for the electronic submission of certifications
under this subsection.
(6) False statements.--Any statement or
representation made by an entity described in paragraph
(2) to the Secretary shall be subject to section 1001
of title 18, United States Code.
(7) Assessment of food safety programs, systems, and
standards.--If the Secretary determines that the food
safety programs, systems, and standards in a foreign
region, country, or territory are inadequate to ensure
that an article of food is as safe as a similar article
of food that is manufactured, processed, packed, or
held in the United States in accordance with the
requirements of this Act, the Secretary shall, to the
extent practicable, identify such inadequacies and
establish a process by which the foreign region,
country, or territory may inform the Secretary of
improvements made to such food safety program, system,
or standard and demonstrate that those controls are
adequate to ensure that an article of food is as safe
as a similar article of food that is manufactured,
processed, packed, or held in the United States in
accordance with the requirements of this Act.
(r)(1) The Secretary may require, pursuant to the regulations
promulgated under paragraph (4)(A), as a condition of granting
admission to a drug imported or offered for import into the
United States, that the importer electronically submit
information demonstrating that the drug complies with
applicable requirements of this Act.
(2) The information described under paragraph (1) may
include--
(A) information demonstrating the regulatory status
of the drug, such as the new drug application,
abbreviated new drug application, or investigational
new drug or drug master file number;
(B) facility information, such as proof of
registration and the unique facility identifier;
(C) indication of compliance with current good
manufacturing practice, testing results, certifications
relating to satisfactory inspections, and compliance
with the country of export regulations; and
(D) any other information deemed necessary and
appropriate by the Secretary to assess compliance of
the article being offered for import.
(3) Information requirements referred to in paragraph (2)(C)
may, at the discretion of the Secretary, be satisfied--
(A) through representation by a foreign government,
if an inspection is conducted by a foreign government
using standards and practices as determined appropriate
by the Secretary;
(B) through representation by a foreign government or
an agency of a foreign government recognized under
section 809; or
(C) other appropriate documentation or evidence as
described by the Secretary.
(4)(A) Not later than 18 months after the date of enactment
of the Food and Drug Administration Safety and Innovation Act,
the Secretary shall adopt final regulations implementing this
subsection. Such requirements shall be appropriate for the type
of import, such as whether the drug is for import into the
United States for use in preclinical research or in a clinical
investigation under an investigational new drug exemption under
505(i).
(B) In promulgating the regulations under subparagraph (A),
the Secretary--
(i) may, as appropriate, take into account
differences among importers and types of imports, and,
based on the level of risk posed by the imported drug,
provide for expedited clearance for those importers
that volunteer to participate in partnership programs
for highly compliant companies and pass a review of
internal controls, including sourcing of foreign
manufacturing inputs, and plant inspections; and
(ii) shall--
(I) issue a notice of proposed rulemaking
that includes the proposed regulation;
(II) provide a period of not less than 60
days for comments on the proposed regulation;
and
(III) publish the final regulation not less
than 30 days before the effective date of the
regulation.
(C) Notwithstanding any other provision of law, the Secretary
shall promulgate regulations implementing this subsection only
as described in subparagraph (B).
(s) Registration of Commercial Importers.--
(1) Registration.--The Secretary shall require a
commercial importer of drugs--
(A) to be registered with the Secretary in a
form and manner specified by the Secretary; and
(B) subject to paragraph (4), to submit, at
the time of registration, a unique identifier
for the principal place of business for which
the importer is required to register under this
subsection.
(2) Regulations.--
(A) In general.--The Secretary, in
consultation with the Secretary of Homeland
Security acting through U.S. Customs and Border
Protection, shall promulgate regulations to
establish good importer practices that specify
the measures an importer shall take to ensure
imported drugs are in compliance with the
requirements of this Act and the Public Health
Service Act.
(B) Procedure.--In promulgating a regulation
under subparagraph (A), the Secretary shall--
(i) issue a notice of proposed
rulemaking that includes the proposed
regulation;
(ii) provide a period of not less
than 60 days for comments on the
proposed regulation; and
(iii) publish the final regulation
not less than 30 days before the
regulation's effective date.
(C) Restrictions.--Notwithstanding any other
provision of Federal law, in implementing this
subsection, the Secretary shall only promulgate
regulations as described in subparagraph (B).
(D) Effective date.--In establishing the
effective date of the regulations under
subparagraph (A), the Secretary 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.
(3) Discontinuance of registration.--The Secretary
shall discontinue the registration of any commercial
importer of drugs that fails to comply with the
regulations promulgated under this subsection.
(4) Unique facility identifier.--The Secretary shall
specify the unique facility identifier system that
shall be used by registrants under paragraph (1). The
requirement to include a unique facility identifier in
a registration under paragraph (1) shall not apply
until the date that the identifier system is specified
by the Secretary under the preceding sentence.
(5) Exemptions.--The Secretary, by notice in the
Federal Register, may establish exemptions from the
requirements of this subsection.
* * * * * * *
SEC. 809. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.
(a) Inspection.--The Secretary--
(1) may enter into arrangements and agreements with a
foreign government or an agency of a foreign government
to recognize the inspection of foreign establishments
registered under section 510(i) in order to facilitate
risk-based inspections in accordance with the schedule
established in section 510(h)(3) or 510(h)(2) (as
applicable);
(2) may enter into arrangements and agreements with a
foreign government or an agency of a foreign government
under this section only with a foreign government or an
agency of a foreign government that the Secretary has
determined as having the capability of conducting
inspections that meet the applicable requirements of
this Act; and
(3) shall perform such reviews and audits of drug
safety programs, systems, and standards of a foreign
government or agency for the foreign government as the
Secretary deems necessary to determine that the foreign
government or agency of the foreign government is
capable of conducting inspections that meet the
applicable requirements of this Act.
(b) Results of Inspection.--The results of inspections
performed by a foreign government or an agency of a foreign
government under this section may be used as--
(1) evidence of compliance with section 501(a)(2)(B)
or section 801(r); and
(2) for any other purposes as determined appropriate
by the Secretary.
* * * * * * *
----------
FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT
* * * * * * *
SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.
(a) Table of Contents.--The table of contents of this Act is
as follows:
* * * * * * *
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
* * * * * * *
[Sec. 404. Sunset dates.]
* * * * * * *
TITLE I--FEES RELATING TO DRUGS
* * * * * * *
SEC. 105. SUNSET DATES.
[(a) Authorization.--Sections 735 and 736 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease
to be effective October 1, 2017.
[(b) Reporting Requirements.--Section 736B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease to
be effective January 31, 2018.]
(c) Previous Sunset Provision.--
(1) In general.--Section 106 of the Food and Drug
Administration Amendments Act of 2007 (Public Law 110-
85) is repealed.
(2) Conforming amendment.--The Food and Drug
Administration Amendments Act of 2007 (Public Law 110-
85) is amended in the table of contents in section 2,
by striking the item relating to section 106.
(d) Technical Clarifications.--
(1) Effective September 30, 2007--
(A) section 509 of the Prescription Drug User
Fee Amendments Act of 2002 (Title V of Public
Law 107-188) is repealed; and
(B) the Public Health Security and
Bioterrorism Preparedness and Response Act of
2002 (Public Law 107-188) is amended in the
table of contents in section 1(b), by striking
the item relating to section 509.
(2) Effective September 30, 2002--
(A) section 107 of the Food and Drug
Administration Modernization Act of 1997
(Public Law 105-115) is repealed; and
(B) the table of contents in section 1(c) of
such Act is amended by striking the item
related to section 107.
(3) Effective September 30, 1997, section 105 of the
Prescription Drug User Fee Act of 1992 (Public Law 102-
571) is repealed.
* * * * * * *
TITLE III--FEES RELATING TO GENERIC DRUGS
* * * * * * *
SEC. 304. SUNSET DATES.
[(a) Authorization.--Sections 744A and 744B of the Federal
Food, Drug, and Cosmetic Act, as added by section 302 of this
Act, shall cease to be effective October 1, 2017.
[(b) Reporting Requirements.--Section 744C of the Federal
Food, Drug, and Cosmetic Act, as added by section 303 of this
Act, shall cease to be effective January 31, 2018.]
* * * * * * *
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
* * * * * * *
[SEC. 404. SUNSET DATES.
[(a) Authorization.--Sections 744G and 744H of the Federal
Food, Drug, and Cosmetic Act, as added by section 402 of this
Act, shall cease to be effective October 1, 2017.
[(b) Reporting Requirements.--Section 744I of the Federal
Food, Drug, and Cosmetic Act, as added by section 403 of this
Act, shall cease to be effective January 31, 2018.]
* * * * * * *
----------
MEDICAL DEVICE USER FEE AMENDMENTS OF 2012
* * * * * * *
TITLE II--FEES RELATING TO DEVICES
* * * * * * *
SEC. 207. SUNSET CLAUSE.
[(a) In General.--Sections 737 and 738 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be
effective October 1, 2017. Section 738A (21 U.S.C. 739j-1) of
the Federal Food, Drug, and Cosmetic Act (regarding
reauthorization and reporting requirements) shall cease to be
effective January 31, 2018.]
(b) Previous Sunset Provision.--
(1) In general.--Section 217 of the Food and Drug
Administration Amendments Act of 2007 (Title II of
Public Law 110-85) is repealed.
(2) Conforming amendment.--The Food and Drug
Administration Amendments Act of 2007 (Public Law 110-
85) is amended in the table of contents in section 2,
by striking the item relating to section 217.
(c) Technical Clarification.--Effective September 30, 2007--
(1) section 107 of the Medical Device User Fee and
Modernization Act of 2002 (Public Law 107-250) is
repealed; and
(2) the table of contents in section 1(b) of such Act
is amended by striking the item related to section 107.
* * * * * * *
----------
ORPHAN DRUG ACT
grants and contracts for development of drugs for rare diseases and
conditions
Sec. 5. (a) The Secretary may make grants to and enter into
contracts with public and private entities and individuals to
assist in (1) defraying the costs of developing drugs for rare
diseases or conditions, including qualified testing expenses,
(2) defraying the costs of developing medical devices for rare
diseases or conditions, and (3) defraying the costs of
developing medical foods for rare diseases or conditions.
(b) For purposes of subsection (a):
(1) The term ``qualified testing'' means--
(A) human clinical testing--
(i) which is carried out under an
exemption for a drug for a rare disease
or condition under section 505(i) of
the Federal Food, Drug, and Cosmetic
Act (or regulations issued under such
section); and
(ii) which occurs before the date on
which an application with respect to
such drug is submitted under section
505(b) of such Act or under section 351
of the Public Health Service Act;
(B) preclinical testing involving a drug for
a rare disease or condition which occurs after
the date such drug is designated under section
526 of such Act and before the date on which an
application with respect to such drug is
submitted under section 505(b) of such Act or
under section 351 of the Public Health Service
Act; and
(C) prospectively planned and designed
observational studies and other analyses
conducted to assist in the understanding of the
natural history of a rare disease or condition
and in the development of a therapy, including
studies and analyses to--
(i) develop or validate a drug
development tool related to a rare
disease or condition; or
(ii) understand the full spectrum of
the disease manifestations, including
describing genotypic and phenotypic
variability and identifying and
defining distinct subpopulations
affected by a rare disease or
condition.
(2) The term ``rare disease or condition'' means (1)
in the case of a drug, any disease or condition which
(A) affects less than 200,000 persons in the United
States, or (B) affects more than 200,000 in the United
States and for which there is no reasonable expectation
that the cost of developing and making available in the
United States a drug for such disease or condition will
be recovered from sales in the United States of such
drugs, (2) in the case of a medical device, any disease
or condition that occurs so infrequently in the United
States that there is no reasonable expectation that a
medical device for such disease or condition will be
developed without assistance under subsection (a), and
(3) in the case of a medical food, any disease or
condition that occurs so infrequently in the United
States that there is no reasonable expectation that a
medical food for such disease or condition will be
developed without assistance under subsection (a).
Determinations under the preceding sentence with
respect to any drug shall be made on the basis of the
facts and circumstances as of the date the request for
designation of the drug under section 526 of the
Federal Food, Drug, and Cosmetic Act is made.
(3) The term ``medical food'' means a food which is
formulated to be consumed or administered enterally
under the supervision of a physician and which is
intended for the specific dietary management of a
disease or condition for which distinctive nutritional
requirements, based on recognized scientific
principles, are established by medical evaluation.
(c) Authorization of Appropriations.--For grants and
contracts under subsection (a), there is authorized to be
appropriated $30,000,000 for each of fiscal years [2013 through
2017] 2018 through 2022.
----------
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE IV--NATIONAL RESEARCH INSTITUTES
* * * * * * *
Part B--General Provisions Respecting National Research Institutes
* * * * * * *
SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.
(a) List of Priority Issues in Pediatric Therapeutics.--
(1) In general.--Not later than one year after the
date of the enactment of the Best Pharmaceuticals for
Children Act of 2007, the Secretary, acting through the
Director of the National Institutes of Health and in
consultation with the Commissioner of Food and Drugs
and experts in pediatric research, shall develop and
publish a priority list of needs in pediatric
therapeutics, including drugs, biological products, or
indications that require study. The list shall be
revised every three years.
(2) Consideration of available information.--In
developing and prioritizing the list under paragraph
(1), the Secretary--
(A) shall consider--
(i) therapeutic gaps in pediatrics
that may include developmental
pharmacology, pharmacogenetic
determinants of drug response,
metabolism of drugs and biologics in
children, and pediatric clinical
trials;
(ii) particular pediatric diseases,
disorders or conditions where more
complete knowledge and testing of
therapeutics, including drugs and
biologics, may be beneficial in
pediatric populations; and
(iii) the adequacy of necessary
infrastructure to conduct pediatric
pharmacological research, including
research networks and trained pediatric
investigators; and
(B) may consider the availability of
qualified countermeasures (as defined in
section 319F-1), security countermeasures (as
defined in section 319F-2), and qualified
pandemic or epidemic products (as defined in
section 319F-3) to address the needs of
pediatric populations, in consultation with the
Assistant Secretary for Preparedness and
Response, consistent with the purposes of this
section.
(b) Pediatric Studies and Research.--The Secretary, acting
through the National Institutes of Health, shall award funds to
entities that have the expertise to conduct pediatric clinical
trials or other research (including qualified universities,
hospitals, laboratories, contract research organizations,
practice groups, federally funded programs such as pediatric
pharmacology research units, other public or private
institutions, or individuals) to enable the entities to conduct
the drug studies or other research on the issues described in
paragraphs (1) and (2)(A) of subsection (a). The Secretary may
use contracts, grants, or other appropriate funding mechanisms
to award funds under this subsection.
(c) Process for Proposed Pediatric Study Requests and
Labeling Changes.--
(1) Submission of proposed pediatric study request.--
The Director of the National Institutes of Health
shall, as appropriate, submit proposed pediatric study
requests for consideration by the Commissioner of Food
and Drugs for pediatric studies of a specific pediatric
indication identified under subsection (a). Such a
proposed pediatric study request shall be made in a
manner equivalent to a written request made under
subsection (b) or (c) of section 505A of the Federal
Food, Drug, and Cosmetic Act, or section 351(m) of this
Act, including with respect to the information provided
on the pediatric studies to be conducted pursuant to
the request. The Director of the National Institutes of
Health may submit a proposed pediatric study request
for a drug for which--
(A)(i) there is an approved application under
section 505(j) of the Federal Food, Drug, and
Cosmetic Act or section 351(k) of this Act; or
(ii) there is a submitted application that
could be approved under the criteria of such
section; and
(B) there remains no patent listed pursuant
to section 505(b)(1) of the Federal Food, Drug,
and Cosmetic Act, and every three-year and
five-year period referred to in subsection
(c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv),
(j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv)
of section 505 of the Federal Food, Drug, and
Cosmetic Act, or applicable twelve-year period
referred to in section 351(k)(7) of this Act,
and any seven-year period referred to in
section 527 of the Federal Food, Drug, and
Cosmetic Act has ended for at least one form of
the drug; and
(C) additional studies are needed to assess
the safety and effectiveness of the use of the
drug in the pediatric population.
(2) Written request to holders of approved
applications.--The Commissioner of Food and Drugs, in
consultation with the Director of the National
Institutes of Health, may issue a written request based
on the proposed pediatric study request for the
indication or indications submitted pursuant to
paragraph (1) (which shall include a timeframe for
negotiations for an agreement) for pediatric studies
concerning a drug identified under subsection (a) to
all holders of an approved application for the drug.
Such a written request shall be made in a manner
equivalent to the manner in which a written request is
made under subsection (b) or (c) of section 505A of the
Federal Food, Drug, and Cosmetic Act or section 351(m)
of this Act, including with respect to information
provided on the pediatric studies to be conducted
pursuant to the request and using appropriate
formulations for each age group for which the study is
requested.
(3) Requests for proposals.--If the Commissioner of
Food and Drugs does not receive a response to a written
request issued under paragraph (2) not later than 30
days after the date on which a request was issued, the
Secretary, acting through the Director of the National
Institutes of Health and in consultation with the
Commissioner of Food and Drugs, shall publish a request
for proposals to conduct the pediatric studies
described in the written request in accordance with
subsection (b).
(4) Disqualification.--A holder that receives a first
right of refusal shall not be entitled to respond to a
request for proposals under paragraph (3).
(5) Contracts, grants, or other funding mechanisms.--
A contract, grant, or other funding may be awarded
under this section only if a proposal is submitted to
the Secretary in such form and manner, and containing
such agreements, assurances, and information as the
Secretary determines to be necessary to carry out this
section.
(6) Reporting of studies.--
(A) In general.--On completion of a pediatric
study in accordance with an award under this
section, a report concerning the study shall be
submitted to the Director of the National
Institutes of Health and the Commissioner of
Food and Drugs. The report shall include all
data generated in connection with the study,
including a written request if issued.
(B) Availability of reports.--Each report
submitted under subparagraph (A) shall be
considered to be in the public domain (subject
to section 505A(d)(4) of the Federal Food,
Drug, and Cosmetic Act) and shall be assigned a
docket number by the Commissioner of Food and
Drugs. An interested person may submit written
comments concerning such pediatric studies to
the Commissioner of Food and Drugs, and the
written comments shall become part of the
docket file with respect to each of the drugs.
(C) Action by commissioner.--The Commissioner
of Food and Drugs shall take appropriate action
in response to the reports submitted under
subparagraph (A) in accordance with paragraph
(7).
(7) Requests for labeling change.--During the 180-day
period after the date on which a report is submitted
under paragraph (6)(A), the Commissioner of Food and
Drugs shall--
(A) review the report and such other data as
are available concerning the safe and effective
use in the pediatric population of the drug
studied;
(B) negotiate with the holders of approved
applications for the drug studied for any
labeling changes that the Commissioner of Food
and Drugs determines to be appropriate and
requests the holders to make; and
(C)(i) place in the public docket file a copy
of the report and of any requested labeling
changes; and
(ii) publish in the Federal Register and
through a posting on the Web site of the Food
and Drug Administration a summary of the report
and a copy of any requested labeling changes.
(8) Dispute resolution.--
(A) Referral to pediatric advisory
committee.--If, not later than the end of the
180-day period specified in paragraph (7), the
holder of an approved application for the drug
involved does not agree to any labeling change
requested by the Commissioner of Food and Drugs
under that paragraph, the Commissioner of Food
and Drugs shall refer the request to the
Pediatric Advisory Committee.
(B) Action by the pediatric advisory
committee.--Not later than 90 days after
receiving a referral under subparagraph (A),
the Pediatric Advisory Committee shall--
(i) review the available information
on the safe and effective use of the
drug in the pediatric population,
including study reports submitted under
this section; and
(ii) make a recommendation to the
Commissioner of Food and Drugs as to
appropriate labeling changes, if any.
(9) FDA determination.--Not later than 30 days after
receiving a recommendation from the Pediatric Advisory
Committee under paragraph (8)(B)(ii) with respect to a
drug, the Commissioner of Food and Drugs shall consider
the recommendation and, if appropriate, make a request
to the holders of approved applications for the drug to
make any labeling change that the Commissioner of Food
and Drugs determines to be appropriate.
(10) Failure to agree.--If a holder of an approved
application for a drug, within 30 days after receiving
a request to make a labeling change under paragraph
(9), does not agree to make a requested labeling
change, the Commissioner of Food and Drugs may deem the
drug to be misbranded under the Federal Food, Drug, and
Cosmetic Act.
(11) No effect on authority.--Nothing in this
subsection limits the authority of the United States to
bring an enforcement action under the Federal Food,
Drug, and Cosmetic Act when a drug lacks appropriate
pediatric labeling. Neither course of action (the
Pediatric Advisory Committee process or an enforcement
action referred to in the preceding sentence) shall
preclude, delay, or serve as the basis to stay the
other course of action.
(d) Dissemination of Pediatric Information.--Not later than
one year after the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007, the Secretary, acting
through the Director of the National Institutes of Health,
shall study the feasibility of establishing a compilation of
information on pediatric drug use and report the findings to
Congress.
(e) Authorization of Appropriations.--
(1) In general.--There are authorized to be
appropriated to carry out this section, $25,000,000 for
each of fiscal years [2013 through 2017] 2018 through
2022.
(2) Availability.--Any amount appropriated under
paragraph (1) shall remain available to carry out this
section until expended.
* * * * * * *
----------
SECTION 305 OF THE PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT
OF 2007
SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE
AVAILABILITY.
(a) In General.--
(1) Request for proposals.--Not later than 90 days
after the date of the enactment of this Act, the
Secretary of Health and Human Services shall issue a
request for proposals for 1 or more grants or contracts
to nonprofit consortia for demonstration projects to
promote pediatric device development.
(2) Determination on Grants or Contracts.--Not later
than 180 days after the date the Secretary of Health
and Human Services issues a request for proposals under
paragraph (1), the Secretary shall make a determination
on the grants or contracts under this section.
(b) Application.--A nonprofit consortium that desires to
receive a grant or contract under this section shall submit an
application to the Secretary of Health and Human Services at
such time, in such manner, and containing such information as
the Secretary may require.
(c) Use of Funds.--A nonprofit consortium that receives a
grant or contract under this section shall facilitate the
development, production, and distribution of pediatric medical
devices by--
(1) encouraging innovation and connecting qualified
individuals with pediatric device ideas with potential
manufacturers;
(2) mentoring and managing pediatric device projects
through the development process, including product
identification, prototype design, device development,
and marketing;
(3) connecting innovators and physicians to existing
Federal and non-Federal resources, including resources
from the Food and Drug Administration, the National
Institutes of Health, the Small Business
Administration, the Department of Energy, the
Department of Education, the National Science
Foundation, the Department of Veterans Affairs, the
Agency for Healthcare Research and Quality, and the
National Institute of Standards and Technology;
(4) assessing the scientific and medical merit of
proposed pediatric device projects; and
(5) providing assistance and advice as needed on
business development, personnel training, prototype
development, postmarket needs, and other activities
consistent with the purposes of this section.
(d) Coordination.--
(1) National institutes of health.--Each consortium
that receives a grant or contract under this section
shall--
(A) coordinate with the National Institutes
of Health's pediatric device contact point or
office, designated under section 402(b)(23) of
the Public Health Service Act, as added by
section 304(a) of this Act; and
(B) provide to the National Institutes of
Health any identified pediatric device needs
that the consortium lacks sufficient capacity
to address or those needs in which the
consortium has been unable to stimulate
manufacturer interest.
(2) Food and drug administration.--Each consortium
that receives a grant or contract under this section
shall coordinate with the Commissioner of Food and
Drugs and device companies to facilitate the
application for approval or clearance of devices
labeled for pediatric use.
(3) Effectiveness and outcomes.--Each consortium that
receives a grant or contract under this section shall
annually report to the Secretary of Health and Human
Services on the status of pediatric device development,
production, and distribution that has been facilitated
by the consortium.
(e) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section $5,250,000 for
each of fiscal years [2013 through 2017] 2018 through 2022.
----------
21ST CENTURY CURES ACT
* * * * * * *
TITLE III--DEVELOPMENT
* * * * * * *
Subtitle F--Medical Device Innovations
SEC. 3051. BREAKTHROUGH DEVICES.
(a) In general.--Chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended [by inserting
after section 515B] by inserting after section 515A, as added
by section 3034(b), the following:
``SEC. 515C. BREAKTHROUGH DEVICES
``(a) Purpose.--The purpose of this section is to encourage
the Secretary, and provide the Secretary with sufficient
authority, to apply efficient and flexible approaches to
expedite the development of, and prioritize the Food and Drug
Administration's review of, devices that represent breakthrough
technologies.
``(b) Establishment of Program.--The Secretary shall
establish a program to expedite the development of, and provide
for the priority review for, devices, as determined by the
Secretary--
``(1) that provide for more effective treatment or
diagnosis of life-threatening or irreversibly
debilitating human disease or conditions; and
``(2)(A) that represent breakthrough technologies;
``(B) for which no approved or cleared alternatives
exist;
``(C) that offer significant advantages over existing
approved or cleared alternatives, including the
potential, compared to existing approved alternatives,
to reduce or eliminate the need for hospitalization,
improve patient quality of life, facilitate patients'
ability to manage their own care (such as through self-
directed personal assistance), or establish long-term
clinical efficiencies; or
``(D) the availability of which is in the best
interest of patients.
``(c) Request for designation.--A sponsor of a device may
request that the Secretary designate such device for expedited
development and priority review under this section. Any such
request for designation may be made at any time prior to the
submission of an application under section 515(c), a
notification under section 510(k), or a petition for
classification under section 513(f)(2).
``(d) Designation Process.--
``(1) In general.--Not later than 60 calendar days
after the receipt of a request under subsection (c),
the Secretary shall determine whether the device that
is the subject of the request meets the criteria
described in subsection (b). If the Secretary
determines that the device meets the criteria, the
Secretary shall designate the device for expedited
development and priority review.
``(2) Review.--Review of a request under subsection
(c) shall be undertaken by a team that is composed of
experienced staff and senior managers of the Food and
Drug Administration.
``(3) Withdrawal.--The Secretary may not withdraw a
designation granted under this section on the basis of
the criteria under subsection (b) no longer applying
because of the subsequent clearance or approval of
another device that--
``(A) was designated under this section; or
``(B) was given priority review under section
515(d)(5), as in effect prior to the date of
enactment of the 21st Century Cures Act.
``(e) Expedited Development and Priority Review.--
``(1) Actions.--For purposes of expediting the
development and review of devices designated under
subsection (d) the Secretary shall--
``(A) assign a team of staff, including a
team leader with appropriate subject matter
expertise and experience, for each device for
which a request is submitted under subsection
(c);
``(B) provide for oversight of the team by
senior agency personnel to facilitate the
efficient development of the device and the
efficient review of any submission described in
subsection (c) for the device;
``(C) adopt an efficient process for timely
dispute resolution;
``(D) provide for interactive and timely
communication with the sponsor of the device
during the development program and review
process;
``(E) expedite the Secretary's review of
manufacturing and quality systems compliance,
as applicable;
``(F) disclose to the sponsor, not less than
5 business days in advance, the topics of any
consultation the Secretary intends to undertake
with external experts or an advisory committee
concerning the sponsor's device and provide the
sponsor the opportunity to recommend such
external experts;
``(G) provide for advisory committee input,
as the Secretary determines appropriate
(including in response to the request of the
sponsor) for applications submitted under
section 515(c); and
``(H) assign staff to be available within a
reasonable time to address questions by
institutional review committees concerning the
conditions and clinical testing requirements
applicable to the investigational use of the
device pursuant to an exemption under section
520(g).
``(2) Additional actions.--In addition to the actions
described in paragraph (1), for purposes of expediting
the development and review of devices designated under
subsection (d), the Secretary, in collaboration with
the device sponsor, may, as appropriate--
``(A) coordinate with the sponsor regarding
early agreement on a data development plan;
``(B) take steps to ensure that the design of
clinical trials is as efficient and flexible as
practicable, when scientifically appropriate;
``(C) facilitate, when scientifically
appropriate, expedited and efficient
development and review of the device through
utilization of timely postmarket data
collection with regard to application for
approval under section 515(c); and
``(D) agree in writing to clinical protocols
that the Secretary will consider binding on the
Secretary and the sponsor, subject to--
``(i) changes to such protocols
agreed to in writing by the sponsor and
the Secretary; or
``(ii) a decision, made by the
director of the office responsible for
reviewing the device submission, that a
substantial scientific issue essential
to determining the safety or
effectiveness of such device exists,
provided that such decision is in
writing, and is made only after the
Secretary provides to the device
sponsor or applicant an opportunity for
a meeting at which the director and the
sponsor or applicant are present and at
which the director documents the
substantial scientific issue.
``(f) Priority Review Guidance.--
``(1) Content.--Not later than 1 year after the date
of enactment of the 21st Century Cures Act, the
Secretary shall issue guidance on the implementation of
this section. Such guidance shall--
``(A) set forth the process by which a person
may seek a designation under subsection (d);
``(B) provide a template for requests under
subsection (c);
``(C) identify the criteria the Secretary
will use in evaluating a request for
designation under this section; and
``(D) identify the criteria and processes the
Secretary will use to assign a team of staff,
including team leaders, to review devices
designated for expedited development and
priority review, including any training
required for such personnel to ensure effective
and efficient review.
``(2) Process.--Prior to finalizing the guidance
under paragraph (1), the Secretary shall seek public
comment on a proposed guidance.
``(g) Rule of Construction.--Nothing in this section shall be
construed to affect--
``(1) the criteria and standards for evaluating an
application pursuant to section 515(c), a report and
request for classification under section 513(f)(2), or
a report under section 510(k), including the
recognition of valid scientific evidence as described
in section 513(a)(3)(B) and consideration and
application of the least burdensome means of evaluating
device effectiveness or demonstrating substantial
equivalence between devices with differing
technological characteristics, as applicable;
``(2) the authority of the Secretary with respect to
clinical holds under section 520(g)(8)(A);
``(3) the authority of the Secretary to act on an
application pursuant to section 515(d) before
completion of an establishment inspection, as the
Secretary determines appropriate; or
``(4) the authority of the Secretary with respect to
postmarket surveillance under sections 519(h) and
522.''.
(b) Documentation and Review of Significant Decisions.--
Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360g-1(a)(1)) is amended by inserting ``a request
for designation under section 515C,'' after ``application under
section 515,''.
(c) Termination of Previous Program.--
(1) In general.--Section 515(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360e(d)) is amended--
(A) by striking paragraph (5); and
(B) by redesignating paragraph (6) as
paragraph (5).
(2) Conforming amendment.--Section 737(5) of the
Federal Food, Drug, and Cosmetics Act (21 U.S.C.
379i(5)) is amended by striking ``515(d)(6)'' and
inserting ``515(d)(5)''.
(d) Report.--On January 1, 2019, the Secretary of Health and
Human Services shall issue a report to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives--
(1) on the program under section 515C of the Federal
Food, Drug, and Cosmetic Act, as added by subsection
(a), in bringing safe and effective devices included in
such program to patients as soon as possible; and
(2) that includes recommendations, if any, to
strengthen the program to better meet patient device
needs in a manner as timely as possible.
* * * * * * *
Subtitle G--Improving Scientific Expertise and Outreach at FDA
* * * * * * *
SEC. 3075. DRUG SURVEILLANCE.
(a) New drugs.--Section 505(k)(5) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(k)(5)), [as amended by section
2074] as amended by section 3102, is further amended--
(1) in subparagraph (A), by striking ``, bi-weekly
screening'' and inserting ``screenings'';
(2) in subparagraph (B), as redesignated by [section
2074(1)(C)] section 3102(1)(C), by striking the period
at the end and inserting ``; and''; and
(3) by adding at the end the following:
``(C) make available on the Internet website of the
Food and Drug Administration--
``(i) guidelines, developed with input from
experts qualified by scientific training and
experience to evaluate the safety and
effectiveness of drugs, that detail best
practices for drug safety surveillance using
the Adverse Event Reporting System; and
``(ii) criteria for public posting of adverse
event signals.''.
(b) FAERS Revision.--Section 505(r)(2)(D) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(r)(2)(D)) is
amended by striking ``, by 18 months'' and all that follows
through the semicolon at the end of the subparagraph and
inserting ``and making publicly available on the Internet
website established under paragraph (1) best practices for drug
safety surveillance activities for drugs approved under this
section or section 351 of the Public Health Service Act;''.
(c) Risk evaluation and mitigation strategies.--Section 505-
1(f)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355-1(f)(5)) is amended--
(1) in the matter preceding subparagraph (A), by
inserting ``or other advisory committee'' after ``(or
successor committee)''; and
(2) in subparagraph (B), by striking ``at least
annually,'' and inserting ``periodically''.
* * * * * * *
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