§ 806.40. Public availability of reports.
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/us/cfr/t21/s§ 806.40·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Any report submitted under this part is available for public disclosure in accordance with part 20 of this chapter.
(b)Before public disclosure of a report, FDA will delete from the report:
(1)Any information that constitutes trade secret or confidential commercial or financial information under § 20.61 of this chapter; and
(2)Any personnel, medical, or similar information, including the serial numbers of implanted devices, which would constitute a clearly unwarranted invasion of personal privacy under § 20.63 of this chapter or 5 U.S.C. 552(b)(6); provided, that except for the information under § 20.61 of this chapter or 5 U.S.C. 552(b)(4), FDA will disclose to a patient who requests a report all the information in the report concerning that patient.
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§ 806.40
Public availability of reports.
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