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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3204 Introduced in House (IH)]

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.

    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 ``Guidance Accountability and 
Transparency Act of 2011''.

SEC. 2. PUBLIC PARTICIPATION IN ISSUANCE OF FDA GUIDANCE DOCUMENTS.

    Subparagraph (C) of section 701(h)(1) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 371(h)(1)) is amended to read as follows:
                    ``(C) For any guidance document that sets forth 
                initial interpretations of a statute or regulation, 
                sets forth changes in interpretation or policy that are 
                of more than a minor nature, includes complex 
                scientific issues, or covers highly controversial 
                issues--
                            ``(i) the Secretary shall--
                                    ``(I) at least 3 months before 
                                issuance of a draft, publish notice in 
                                the Federal Register of the Secretary's 
                                intent to prepare such a guidance 
                                document; and
                                    ``(II) during preparation and 
                                before issuance of a draft, meet with 
                                interested stakeholders and solicit 
                                public comment;
                            ``(ii) if the Secretary for good cause 
                        finds that compliance with clause (i) is 
                        impracticable, unnecessary, or contrary to the 
                        public interest--
                                    ``(I) the Secretary shall publish 
                                such finding and a brief statement of 
                                the reasons therefor in the Federal 
                                Register;
                                    ``(II) clause (i) shall not apply; 
                                and
                                    ``(III) during a period of at least 
                                3 months beginning not later than the 
                                date of issuance of a draft, the 
                                Secretary shall meet with interested 
                                stakeholders and solicit public 
                                comment;
                            ``(iii) upon issuance of a draft under 
                        clause (i) or (ii), the Secretary shall--
                                    ``(I) designate the draft as 
                                proposed or final; and
                                    ``(II) not later than 12 months 
                                after the date of issuance of a 
                                proposed draft, issue a final draft in 
                                accordance with clauses (i) and (ii);
                            ``(iv) if the Secretary issues a proposed 
                        draft and fails to finalize the draft by the 
                        deadline determined under clause (iii)(II), the 
                        Secretary shall, beginning on the date of such 
                        deadline, treat the proposed draft as null and 
                        void; and
                            ``(v) not less than every 5 years after the 
                        issuance of a final guidance document in 
                        accordance with clause (iii), the Secretary 
                        shall--
                                    ``(I) conduct a retrospective 
                                analysis of such guidance document to 
                                ensure it is not outmoded, ineffective, 
                                insufficient, or excessively 
                                burdensome; and
                                    ``(II) based on such analysis, 
                                modify, streamline, expand, or repeal 
                                the guidance document in accordance 
                                with what has been learned.
                    ``(D) A notice to industry guidance letter, a 
                notice to industry advisory letter, and any similar 
                notice that sets forth initial interpretations of a 
                statute or regulation, sets forth changes in 
                interpretation or policy that are of more than a minor 
                nature, includes complex scientific issues, or covers 
                highly controversial issues shall be treated as a 
                guidance document for purposes of subparagraph (C).''.
                                 <all>
```