Section 10.20 - Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure

1 Analyses of this regulation by attorneys

  1. FDA Giveth and Taketh Away as It Publishes Its Second Proposed Rule Concerning the Section 503A Bulk Substances List

    Hyman, Phelps & McNamara, P.C.Karla L. PalmerSeptember 11, 2019

    It will also continue to add or decline to add other substances to its final list on a rolling basis. FDA notes that, concerning other substances that have already been either added or removed from the list, interested individuals and organizations may petition FDA to amend the Section 503A Bulks List to consider information that is “different from that which FDA presented to the PCAC” (citing the citizens petition rule at 21 C.F.R. § 10.20). FDA also states that, for substances that have not “yet been addressed in a rulemaking,” interested individuals and entities should submit comments to FDA’s bulks docket (FDA-2015-N-3534).