20.100—Applicability; cross-reference to other regulations.
(a)
The provisions set forth in this subpart or cross-referenced in paragraph (c) of this section state the way in which specific categories of Food and Drug Administration records are handled upon a request for public disclosure. The exemptions established in subpart D of this part and the limitations on exemptions established in subpart E of this part shall be applicable to all Food and Drug Administration records, as provided in §§ 20.60 and 20.80. Accordingly, a record that is ordinarily available for public disclosure in accordance with this part or under other regulations is not available for such disclosure to the extent that it falls within an exemption contained in subpart D of this part except as provided by the limitations on exemptions specified in subpart E of this part.
(b)
The Commissioner, on his own initiative or on the petition of any interested person, may amend this subpart or promulgate and cross-reference additional regulations to state the status of additional categories of documents to settle pending questions or to reflect court decisions.
(c)
In addition to the provisions of this part, rules on the availability of the following specific categories of Food and Drug Administration records are established by regulations in this chapter:
(3)
Environmental assessments; finding of no significant impact, in § 25.51 of this chapter, or draft and final environmental impact statements, in § 25.52 of this chapter.
(6)
Information on thermal processing of low-acid foods packaged in hermetically sealed containers, in § 108.35(l) of this chapter.
(8)
Action levels for natural and unavoidable defects in food for human use, in § 110.110(e) of this chapter.
(12)
Investigational new animal drug notice and a new animal drug application file for an antibiotic drug, in § 514.10 of this chapter.
(26)
Cosmetic product ingredient and cosmetic raw material composition statements, § 720.8 of this chapter.
(30)
Data and information submitted to the Commissioner or to classification panels in connection with the classification or reclassification of devices intended for human use, in § 860.5 of this chapter.
(31)
Data and information submitted in offers to develop a proposed performance standard for medical devices, in § 861.26 of this chapter.
(39)
Data submitted regarding persons receiving an implanted pacemaker device or lead, in § 805.25 of this chapter.