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62 FR 27191, May 19, 1997, unless otherwise noted.
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(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.