[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 3020 Introduced in Senate (IS)]







110th CONGRESS
  2d Session
                                S. 3020

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
                  postmarket surveillance of devices.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 15, 2008

  Mrs. Boxer introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
                  postmarket surveillance of devices.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Food and Drug Administration 
Accountability and Transparency Act''.

SEC. 2. POSTMARKET SURVEILLANCE OF DEVICES.

    (a) Availability of Postmarket Surveillance Plans.--Section 522 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) is amended by 
adding at the end the following:
    ``(c) Availability of Plans.--
            ``(1) In general.--Subject to paragraph (2), the Secretary 
        shall publish in the Federal Register, and make available to 
        interested persons upon request, a plan (and any amendments to 
        such plan) submitted to the Secretary under subsection (b).
            ``(2) Limitation.--The Secretary shall not disclose 
        information under paragraph (1) that is exempted from 
        disclosure under section 552 of title 5, United States Code 
        (popularly known as the Freedom of Information Act).''.
    (b) Increased Civil Penalties for Failure To Comply With Postmarket 
Surveillance Plan.--
            (1) In general.--Section 303(f) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 333(f)) is amended--
                    (A) by redesignating paragraphs (5), (6), and (7) 
                as paragraphs (6), (7), and (8), respectively; and
                    (B) by inserting after paragraph (4) the following:
    ``(5)(A) Any manufacturer that fails to comply with a requirement 
of section 522, including a requirement of a required surveillance plan 
under such section, 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 manufacturer, the 
        manufacturer shall be subject to a civil monetary penalty of 
        $250,000 for the first 30-day period (or any portion thereof) 
        that the manufacturer 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 manufacturer is making efforts toward correcting the 
violation of the requirement for which the manufacturer is subject to 
such civil penalty.''.
            (2) Conforming amendments.--Section 303(f) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is amended--
                    (A) in paragraph (6), as so redesignated, by 
                striking ``, or (4)'' each place it appears and 
                inserting ``(4), or (5)'';
                    (B) in paragraph (7), as so redesignated, by 
                striking ``(5)(A)'' and inserting ``(6)(A)''; and
                    (C) in paragraph (8), as so redesignated, by 
                striking ``paragraph (6)'' each place it appears and 
                inserting ``paragraph (7)''.

SEC. 3. NOTIFICATIONS.

    Section 518(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360h(a)(1)) is amended by inserting ``or that a violation of 
section 522 by the manufacturer of a device presents an unreasonable 
risk of substantial harm to the public health'' after ``public 
health''.

SEC. 4. EFFECTIVE DATE; APPLICABILITY.

    The amendments made by this Act--
            (1) shall take effect 180 days after the date of enactment 
        of this Act; and
            (2) shall apply to a class II or class III device approved 
        or cleared by the Secretary of Health and Human Services under 
        chapter V of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 351 et seq.) before, on, or after the date of enactment 
        of this Act.
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