§71.15. Confidentiality of data and information in color additive petitions. — Inbound Citations
21 C.F.R. § 71.15
Statutory Authority
Cited by 2 regulations in release Current.
Citations to 21 C.F.R. § 71.15 as a whole
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(4) Color additive petitions, in § 71.15 of this chapter.
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(a) A “PMA file” includes all data and information submitted with or incorporated by reference in the PMA, any IDE incorporated into the PMA, any PMA supplement, any report under § 814.82, any master file, or any other related submission. Any record in the PMA file will be available for public disclosure in accordance with the provisions of this section and part 20. The confidentiality of information in a color additive petition submitted as part of a PMA is governed by § 71.15.