[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3981 Introduced in Senate (IS)]








109th CONGRESS
  2d Session
                                S. 3981

    To amend the Federal Food, Drug, and Cosmetic Act to establish 
   requirements for certain petitions submitted to the Food and Drug 
                Administration, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 28, 2006

  Mr. Kohl (for himself and Mr. Leahy) 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 to establish 
   requirements for certain petitions submitted to the Food and Drug 
                Administration, and for other purposes.

    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 ``Citizen Petition Fairness and 
Accuracy Act of 2006''.

SEC. 2. CITIZEN PETITIONS AND PETITIONS FOR STAY OF AGENCY ACTION.

    Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(5)) is amended by adding at the end the following:
    ``(G)(i) Notwithstanding any other provision of law, any petition 
submitted under section 10.30 or section 10.35 of title 21, Code of 
Federal Regulations (or any successor regulation), shall include a 
statement that to the petitioner's best knowledge and belief, the 
petition--
            ``(I) includes all information and views on which the 
        petitioner relies, including all representative data and 
        information known to the petitioner that is favorable or 
        unfavorable to the petition;
            ``(II) is well grounded in fact and is warranted by law;
            ``(III) is not submitted for an improper purpose, such as 
        to harass or cause unnecessary delay (including unnecessary 
        delay of competition or agency action); and
            ``(IV) does not contain a materially false, misleading, or 
        fraudulent statement.
    ``(ii) The Secretary shall investigate, on receipt of a complaint, 
a request under clause (vi), or on its own initiative, any petition 
submitted under such section 10.30 or section 10.35 (or any successor 
regulation), that--
            ``(I) does not comply with the requirements of clause (i);
            ``(II) may have been submitted for an improper purpose as 
        described in clause (i)(III); or
            ``(III) may contain a materially false, misleading, or 
        fraudulent statement as described in clause (i)(IV).
    ``(iii) If the Secretary finds that the petitioner has knowingly 
and willingly submitted the petition for an improper purpose as 
described in clause (i)(III), or which contains a materially false, 
misleading, or fraudulent statement as described in clause (i)(IV), the 
Secretary may--
            ``(I) impose a civil penalty of not more than $1,000,000, 
        plus attorneys fees and costs of reviewing the petition and any 
        related proceedings;
            ``(II) suspend the authority of the petitioner to submit a 
        petition under such section 10.30 or section 10.35 (or any 
        successor regulation), for a period of not more than 10 years;
            ``(III) revoke permanently the authority of the petitioner 
        to submit a petition under such section 10.30 or section 10.35 
        (or any successor regulation); or
            ``(IV) dismiss the petition at issue in its entirety.
    ``(iv) If the Secretary takes an enforcement action described in 
subclause (I), (II), (III), or (IV) of clause (iii) with respect to a 
petition, the Secretary shall refer that petition to the Federal Trade 
Commission for further action as the Federal Trade Commission finds 
appropriate.
    ``(v) In determining whether to take an enforcement action 
described in subclause (I), (II), (III), or (IV) of clause (iii) with 
respect to a petition, and in determining the amount of any civil 
penalty or the length of any suspension imposed under that clause, the 
Secretary shall consider the specific circumstances of the situation, 
such as the gravity and seriousness of the violation involved, the 
amount of resources expended in reviewing the petition at issue, the 
effect on marketing of competing drugs of the pendency of the 
improperly submitted petition, including whether the timing of the 
submission of the petition appears to have been calculated to cause 
delay in the marketing of any drug awaiting approval, and whether the 
petitioner has a history of submitting petitions in violation of this 
subparagraph.
    ``(vi)(I) Any person aggrieved by a petition filed under such 
section 10.30 or section 10.35 (or any successor regulation), including 
a person filing an application under subsection (b)(2) or (j) of this 
section to which such petition relates, may request that the Secretary 
initiate an investigation described under clause (ii) for an 
enforcement action described under clause (iii).
    ``(II) The aggrieved person shall specify the basis for its belief 
that the petition at issue is false, misleading, fraudulent, or 
submitted for an improper purpose. The aggrieved person shall certify 
that the request is submitted in good faith, is well grounded in fact, 
and not submitted for any improper purpose. Any aggrieved person who 
knowingly and intentionally violates the preceding sentence shall be 
subject to the civil penalty described under clause (iii)(I).
    ``(vii) The Secretary shall take final agency action with respect 
to a petition filed under such section 10.30 or section 10.35 (or any 
successor regulation) within 6 months of receipt of such petition. The 
Secretary shall not extend such 6-month review period, even with 
consent of the petitioner, for any reason, including based upon the 
submission of comments relating to a petition or supplemental 
information supplied by the petitioner. If the Secretary has not taken 
final agency action on a petition by the date that is 6 months after 
the date of receipt of the petition, such petition shall be deemed to 
have been denied on such date.
    ``(viii) The Secretary may promulgate regulations to carry out this 
subparagraph, including to determine whether petitions filed under such 
section 10.30 or section 10.35 (or any successor regulation) merit 
enforcement action by the Secretary under this subparagraph.''.
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