II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Citizen Petition Fair5 ness and Accuracy Act of 2006’’. 


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1 SEC. 2. CITIZEN PETITIONS AND PETITIONS FOR STAY OF 

2 AGENCY ACTION. 

3 Section 505(j)(5) of the Federal Food, Drug, and 

4 Cosmetic Act (21 U.S.C. 355(j)(5)) is amended by adding 

5 at the end the following: 

6 ‘‘(G)(i) Notwithstanding any other provision of law, 

7 any petition submitted under section 10.30 or section 

8 10.35 of title 21, Code of Federal Regulations (or any suc9 cessor regulation), shall include a statement that to the 

10 petitioner’s best knowledge and belief, the petition— 

11 ‘‘(I) includes all information and views on which 

12 the petitioner relies, including all representative data 

13 and information known to the petitioner that is fa14 vorable or unfavorable to the petition; 

15 ‘‘(II) is well grounded in fact and is warranted 

16 by law; 

17 ‘‘(III) is not submitted for an improper pur18 pose, such as to harass or cause unnecessary delay 

19 (including unnecessary delay of competition or agen20 cy action); and 

21 ‘‘(IV) does not contain a materially false, mis22 leading, or fraudulent statement. 

23 ‘‘(ii) The Secretary shall investigate, on receipt of a 

24 complaint, a request under clause (vi), or on its own initia25 tive, any petition submitted under such section 10.30 or 

26 section 10.35 (or any successor regulation), that— 


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1 ‘‘(I) does not comply with the requirements of 

2 clause (i); 

3 ‘‘(II) may have been submitted for an improper 

4 purpose as described in clause (i)(III); or 

5 ‘‘(III) may contain a materially false, mis6 leading, or fraudulent statement as described in 

7 clause (i)(IV). 

8 ‘‘(iii) If the Secretary finds that the petitioner has 

9 knowingly and willingly submitted the petition for an im10 proper purpose as described in clause (i)(III), or which 

11 contains a materially false, misleading, or fraudulent 

12 statement as described in clause (i)(IV), the Secretary 

13 may— 

14 ‘‘(I) impose a civil penalty of not more than 

15 $1,000,000, plus attorneys fees and costs of review16 ing the petition and any related proceedings; 

17 ‘‘(II) suspend the authority of the petitioner to 

18 submit a petition under such section 10.30 or sec19 tion 10.35 (or any successor regulation), for a period 

20 of not more than 10 years; 

21 ‘‘(III) revoke permanently the authority of the 

22 petitioner to submit a petition under such section 

23 10.30 or section 10.35 (or any successor regulation); 

24 or 


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1 ‘‘(IV) dismiss the petition at issue in its en2 tirety. 

3 ‘‘(iv) If the Secretary takes an enforcement action de4 scribed in subclause (I), (II), (III), or (IV) of clause (iii) 

5 with respect to a petition, the Secretary shall refer that 

6 petition to the Federal Trade Commission for further ac7 tion as the Federal Trade Commission finds appropriate. 

8 ‘‘(v) In determining whether to take an enforcement 

9 action described in subclause (I), (II), (III), or (IV) of 

10 clause (iii) with respect to a petition, and in determining 

11 the amount of any civil penalty or the length of any sus12 pension imposed under that clause, the Secretary shall 

13 consider the specific circumstances of the situation, such 

14 as the gravity and seriousness of the violation involved, 

15 the amount of resources expended in reviewing the petition 

16 at issue, the effect on marketing of competing drugs of 

17 the pendency of the improperly submitted petition, includ18 ing whether the timing of the submission of the petition 

19 appears to have been calculated to cause delay in the mar20 keting of any drug awaiting approval, and whether the pe21 titioner has a history of submitting petitions in violation 

22 of this subparagraph. 

23 ‘‘(vi)(I) Any person aggrieved by a petition filed 

24 under such section 10.30 or section 10.35 (or any suc25 cessor regulation), including a person filing an application 


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1 under subsection (b)(2) or (j) of this section to which such 

2 petition relates, may request that the Secretary initiate 

3 an investigation described under clause (ii) for an enforce4 ment action described under clause (iii). 

5 ‘‘(II) The aggrieved person shall specify the basis for 

6 its belief that the petition at issue is false, misleading, 

7 fraudulent, or submitted for an improper purpose. The ag8 grieved person shall certify that the request is submitted 

9 in good faith, is well grounded in fact, and not submitted 

10 for any improper purpose. Any aggrieved person who 

11 knowingly and intentionally violates the preceding sen12 tence shall be subject to the civil penalty described under 

13 clause (iii)(I). 

14 ‘‘(vii) The Secretary shall take final agency action 

15 with respect to a petition filed under such section 10.30 

16 or section 10.35 (or any successor regulation) within 6 

17 months of receipt of such petition. The Secretary shall not 

18 extend such 6-month review period, even with consent of 

19 the petitioner, for any reason, including based upon the 

20 submission of comments relating to a petition or supple21 mental information supplied by the petitioner. If the Sec22 retary has not taken final agency action on a petition by 

23 the date that is 6 months after the date of receipt of the 

24 petition, such petition shall be deemed to have been denied 

25 on such date. 


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1 ‘‘(viii) The Secretary may promulgate regulations to 

2 carry out this subparagraph, including to determine 

3 whether petitions filed under such section 10.30 or section 

4 10.35 (or any successor regulation) merit enforcement ac5 tion by the Secretary under this subparagraph.’’. 

Æ 


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