Least burdensome means for supporting certain administrative order requests with respect to over-the-counter monograph drugs

Section 505G of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h) is amended— (1) by redesignating subsection (q) as subsection (r); and (2) by inserting after subsection (p) the following: (q) Least burdensome means for supporting requests for certain administrative orders (1) In general For purposes of determining whether a drug is generally recognized as safe and effective under section 201(p)(1) when evaluating a request submitted under subsection (b)(5), the Secretary shall apply the least burdensome appropriate means for supporting such a request and satisfying the requirements of this section. (2) Meeting requests (A) In general In the case of an order requested under subsection (b)(5), and if published reports are insufficient to support the requested findings, the Secretary shall meet with the requestor, if the requestor makes a reasonable written request for the meeting, for the purpose of providing recommendations on the types of evidence necessary, including, if appropriate, the potential design and size of any studies to support a demonstration that the drug is generally recognized as safe and effective. (B) Preparation and availability of meeting minutes The Secretary shall prepare, and make available to the requestor, the minutes of any such meeting. (C) Administrative record In the case of any such meeting, the Secretary shall reduce to writing and make a part of the administrative record— (i) any recommendations regarding the parameters of studies under this paragraph that the Secretary provides to the requestor; and (ii) a summary of the meeting discussion. (3) Rule of construction Nothing in this subsection shall be construed to alter, supersede, or limit the criteria— (A) for determining under subsection (b)(5)(A) whether a request is sufficiently complete and formatted to permit a substantive review; or (B) for determining whether a drug is generally recognized as safe and effective under section 201(p)(1)..