I 

112TH CONGRESS 

1ST SESSION H. R. 3204 

To amend the Federal Food, Drug, and Cosmetic Act to ensure public 

participation in the drafting and issuance of Level 1 guidance documents, 

and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 14, 2011 

Mr. GUTHRIE (for himself, Mr. SHIMKUS, Mr. ROGERS of Michigan, Mrs. 

BLACKBURN, Mr. PAULSEN, and Mr. LATTA) introduced the following 

bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

ensure public participation in the drafting and issuance 

of Level 1 guidance documents, 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 ‘‘Guidance Account5 ability and Transparency Act of 2011’’. 


PWALKER on DSK5TPTVN1PROD with BILLS
2 

•HR 3204 IH

1 SEC. 2. PUBLIC PARTICIPATION IN ISSUANCE OF FDA GUID2 ANCE DOCUMENTS. 

3 Subparagraph (C) of section 701(h)(1) of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)) is 

5 amended to read as follows: 

6 ‘‘(C) For any guidance document that sets 

7 forth initial interpretations of a statute or regu8 lation, sets forth changes in interpretation or 

9 policy that are of more than a minor nature, in10 cludes complex scientific issues, or covers highly 

11 controversial issues— 

12 ‘‘(i) the Secretary shall— 

13 ‘‘(I) at least 3 months before 

14 issuance of a draft, publish notice in 

15 the Federal Register of the Sec16 retary’s intent to prepare such a guid17 ance document; and 

18 ‘‘(II) during preparation and be19 fore issuance of a draft, meet with in20 terested stakeholders and solicit public 

21 comment; 

22 ‘‘(ii) if the Secretary for good cause 

23 finds that compliance with clause (i) is im24 practicable, unnecessary, or contrary to the 

25 public interest— 


PWALKER on DSK5TPTVN1PROD with BILLS
3 

•HR 3204 IH

1 ‘‘(I) the Secretary shall publish 

2 such finding and a brief statement of 

3 the reasons therefor in the Federal 

4 Register; 

5 ‘‘(II) clause (i) shall not apply; 

6 and 

7 ‘‘(III) during a period of at least 

8 3 months beginning not later than the 

9 date of issuance of a draft, the Sec10 retary shall meet with interested 

11 stakeholders and solicit public com12 ment; 

13 ‘‘(iii) upon issuance of a draft under 

14 clause (i) or (ii), the Secretary shall— 

15 ‘‘(I) designate the draft as pro16 posed or final; and 

17 ‘‘(II) not later than 12 months 

18 after the date of issuance of a pro19 posed draft, issue a final draft in ac20 cordance with clauses (i) and (ii); 

21 ‘‘(iv) if the Secretary issues a pro22 posed draft and fails to finalize the draft 

23 by the deadline determined under clause 

24 (iii)(II), the Secretary shall, beginning on 


PWALKER on DSK5TPTVN1PROD with BILLS
4 

•HR 3204 IH

1 the date of such deadline, treat the pro2 posed draft as null and void; and 

3 ‘‘(v) not less than every 5 years after 

4 the issuance of a final guidance document 

5 in accordance with clause (iii), the Sec6 retary shall— 

7 ‘‘(I) conduct a retrospective anal8 ysis of such guidance document to en9 sure it is not outmoded, ineffective, 

10 insufficient, or excessively burden11 some; and 

12 ‘‘(II) based on such analysis, 

13 modify, streamline, expand, or repeal 

14 the guidance document in accordance 

15 with what has been learned. 

16 ‘‘(D) A notice to industry guidance letter, 

17 a notice to industry advisory letter, and any 

18 similar notice that sets forth initial interpreta19 tions of a statute or regulation, sets forth 

20 changes in interpretation or policy that are of 

21 more than a minor nature, includes complex sci22 entific issues, or covers highly controversial 

23 issues shall be treated as a guidance document 

24 for purposes of subparagraph (C).’’. 

Æ 


PWALKER on DSK5TPTVN1PROD with BILLS