Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 45 - Public Welfare |
Subtitle A - Department of Health and Human Services |
SubChapter A - General Administration |
Part 1 - [Reserved] |
§ 1.5 - Procedure to petition for review of guidance.
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§ 1.5 Procedure to petition for review of guidance.
(a) Any interested party may petition the Department to withdraw or modify any particular guidance document. Such petitions may include requests to determine whether:
(1) A guidance document, no matter how styled, imposes binding obligations on parties beyond what is required by the terms of applicable statutes and/or regulations;
(2) A component of the Department is using a guidance document to create additional legal obligations beyond what is required by the terms of applicable statutes and/or regulations; or
(3) The Department is improperly exempting a guidance document from the requirements set forth in this part.
(b) As part of a petition under this section, an interested party may ask that the Department modify or withdraw any guidance document in effect at the time of the petition.
(c) Petitions under this section must be addressed to the Department in writing. The Department's guidance repository must include clear instructions to members of the public regarding how to petition for review of guidance, including how such petition can be submitted, and an office at the Department responsible for coordinating such requests.
(d) The Department must respond to all petitions no later than 90 business days after receipt of the petition. The applicable time period for responding is suspended from the time the Department:
(1) Requests additional information from the requestor, until the Department receives the additional information; or
(2) Notifies the requestor of the need to consult with other stakeholders, including but not limited to the Department of Justice or the Department's Office of Inspector General, until the Department completes consultation with other stakeholders.
(e) The Department's written response to petitions must state whether the Department agrees or disagrees with the petition and the Department's rationale. The Department must remedy the substance or use of any guidance documents that it determines in a petition response to be inconsistent with this part or otherwise unlawful. The Department will post all responses to petitions under this section to a designated web page on its guidance repository.