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21CFR1.233

§ 1.233 Are there optional items included in the registration form?

Regulation Text

Yes. FDA encourages, but does not require, you to submit items that are indicated as optional on the Form FDA 3537 that you submit.

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.

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21CFR1.233 — § 1.233 Are there optional items included in the registration form? | CFR Explorer | BioRegHub