How HR 6145 changes current law

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill amends 5 U.S.C. § 553 to require additional disclosures regarding conflicts of interest related to submissions made during rulemaking processes.

• 5 U.S.C. § 553(c)

  After notice required by this section, the agency shall give interested persons an opportunity to participate in the rule making through submission of written data, views, or arguments with or without opportunity for oral presentation. → (1) After notice required; the agency shall, subject to subsections (f) and (h), give interested persons an opportunity to participate in the rule making through submission of written data, views, or arguments with or without opportunity for oral presentation.

  This change clarifies that the requirement for the agency to allow participation is subject to new subsections f and h.

• 5 U.S.C. § 553(c)

  (2) In the case of any submission under paragraph (1) by an interested person that includes a scientific, economic, or technical study or research (or a citation thereto) that the interested person funded directly or indirectly, or the nonpublic results of any scientific, economic, or technical study or research that the interested person funded directly or indirectly, the interested person shall disclose to the agency the following: (A) The amount of any funds that were received by the person who conducted the study or research. (B) The entity that provided the funds referred to in subparagraph (A). (C) Any entity that was allowed to review or revise the study or research, and the extent of that review or revision. (D) Any financial relationship between the person who conducted the study or research, and any person that would be affected by the proposed rule.

  This adds a new requirement for interested persons to disclose funding sources and relationships related to submitted studies or research.

• 5 U.S.C. § 553(f)

  With respect to any submission by an interested person under subsection (c) or any other submission by an interested person relating to a proposed rule or final rule that includes a scientific, economic, or technical study or research by the interested person not published in a publicly available peer-reviewed publication, or any result of a scientific, economic, or technical study or research by the interested person not published in a publicly available peer-reviewed publication, the interested person, in making that submission, shall disclose to the agency-- (1) the source of any funding for the study or research, as applicable; (2) any entity that sponsored the study or research; (3) the extent to which the findings of the study or research were reviewed by a person that may be affected by the rulemaking to which the submission relates; (4) the identity of any person identified under paragraph (3); and (5) the nature of any financial relationship, including a consulting agreement, the support of any expert witness, and the funding of research, between any person that conducted the study or research and any interested person with respect to the rulemaking to which the submission relates.

  This introduces additional disclosure requirements for unpeer-reviewed studies submitted during the rulemaking process.

• 5 U.S.C. § 553(g)

  With respect to a study or research that is submitted by an interested person to an agency under subsection (c), the agency shall ensure that the study or research is available to the public (including on the Internet website of the agency and on the public docket of the agency for the rulemaking) unless disclosure is exempted or excluded under section 552.

  This mandates that studies submitted during rulemaking must be publicly accessible unless otherwise exempted.

• 5 U.S.C. § 553(h)

  If a study or research submitted by an interested person to an agency under subsection (c) presents a conflict described in paragraph (2), the agency shall disclose the conflict to the public on the internet website of the agency and on the public docket of the agency, and by publication in the Federal Register, unless disclosure is exempted or excluded under section 552.

  This requires agencies to disclose conflicts related to certain studies submitted in connection with rulemaking.

• 5 U.S.C. § 553(i)

  In the case of a violation of the requirement to make a disclosure-- (1) under subsection (c)(2) or subsection (f) with respect to a submission; or (2) under subsection (h) with respect to a conflict related to a submission referred to under subsection (g), the agency may exclude from consideration or otherwise disregard the submission, and the agency has no obligation to respond to the submission, except that the submission may be remade with required disclosures during the opportunity for participation referred to in subsection (c)(1). Nothing in this subsection may be construed to affect the level of deference (in accordance with applicable law) accorded to agency action by a court reviewing such action.

  This specifies penalties for failing to make required disclosures in submissions related to rulemaking.