Regulation Text
(a) If FDA, on our own initiative, determines that a waiver of one or more requirements for an individual entity or type of entity is appropriate, we will publish a notice in the Federal Register setting forth the proposed waiver and the reasons for such waiver. The notice will establish a public docket so that interested persons may submit written comments on the proposal.
(b) After considering any comments timely submitted, we will publish a notice in the Federal Register stating whether we are granting the waiver (in whole or in part) and the reasons for our decision.
(c) Any waiver for a type of entity that FDA grants will become effective on the date that notice of the waiver is published in the Federal Register, unless otherwise stated in the notice.
Authority
15 U.S.C. 1333,1453,1454,1455,4402;19 U.S.C. 1490,1491;21 U.S.C. 321,331,332,333,334,335a,342,343,350c,350d,350j,352,355,360b,360ccc,360ccc-1,360ccc-2,362,371,374,381,382,384a,387,387a,387c,393, and2223;42 U.S.C. 216,241,243,262,264,271.