§20.103. Correspondence. — Inbound Citations

(a) The exemptions established in this subpart shall apply to all Food and Drug Administration records, except as provided in subpart E of this part. Accordingly, a record that is ordinarily available for public disclosure in accordance with the provisions in subpart F of this part or of another regulation cross-referenced in § 20.100(c) is not available for such disclosure to the extent that it falls within an exemption contained in this subpart, except as provided by the limitations on exemptions specified in subpart E of this part. For example, correspondence that is ordinarily disclosable under § 20.103 is not disclosable to the extent that it contains trade secrets exempt from disclosure under § 20.61 and is not subject to discretionary release under § 20.82.

(6) All correspondence and written summaries of oral discussions relating to the PMA file, in accordance with the provisions of §§ 20.103 and 20.104.

(b) The limited disclosure of records permitted in § 7.87(c) of this chapter for section 305 hearing records, in § 20.80(b) regarding certain limitations on exemptions, in § 20.103(b) for certain correspondence, and in § 20.104(b) for certain summaries of oral discussions, shall be subject to the special rules stated therein.