§ 20.100 - Applicability; cross-reference to other regulations.

§ 20.100 Applicability; cross-reference to other regulations.

Cross Reference

Link to an amendment published at 87 FR 55914, Sept. 13, 2022.

(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:

(1) Section 305 hearing records, in § 7.87(c) of this chapter.

(2) Flavor ingredient records and notes, in § 101.22(i)(4)(iv) of 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.

(4) Color additive petitions, in § 71.15 of this chapter.

(5) Food standard temporary permits, in § 130.17(k) of this chapter.

(6) Information on thermal processing of low-acid foods packaged in hermetically sealed containers, in § §§ 108.25(k) and 108.35(l) of this chapter.

(7) Food additive petitions, in §§ 171.1(h) and 571.1(h) of this chapter.

(8) Action levels for natural and unavoidable defects in food for human use, in § 110.110(e) of this chapter.

(9) Drug establishment registrations and drug listings, in § 207.81 of this chapter.

(10) Investigational new animal drug notices, in § 514.12 of this chapter.

(11) New animal drug application files, in § 514.11 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.

(13) Methadone patient records, in § 291.505(g) of this chapter.

(14) Investigational new drug notice, in § 312.130 of this chapter.

(15) Labeling for and lists of approved new drug applications, in § 314.430 of this chapter.

(16) Master file for a new drug application, in § 312.420 of this chapter.

(17) New drug application file, in § 314.430 of this chapter.

(18) Data and information submitted for in vitro diagnostic products, in § 809.4 of this chapter.

(19) Data and information submitted for OTC drug review, in § 330.10(a)(2) of this chapter.

(20) Investigational new drug notice for an antibiotic drug, in § 431.70 of this chapter.

(21) Antibiotic drug file, in § 314.430 of this chapter.

(

-(22) [Reserved]

(23) Investigational new drug notice for a biological product, in § 601.50 of this chapter.

(24) Applications for biologics licenses for biological products, in § 601.51 of this chapter.

(25) Cosmetic establishment registrations, in § 710.7 of this chapter.

(26) Cosmetic product ingredient and cosmetic raw material composition statements, § 720.8 of this chapter.

(27) Cosmetic product experience reports, in § 730.7 of this chapter.

(28) Device premarket notification submissions, in § 807.95 of this chapter.

(29) Electronic product information, in §§ 1002.4 and 1002.42 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.

(32) Investigational device exemptions in § 812.38 of this chapter.

(33) Health claims petitions, in § 101.70 of this chapter.

(34) Premarket approval application, in § 814.9 of this chapter.

(35) Report of certain adverse experiences with a medical device, in § 803.9 of this chapter.

(36) Disqualification determination of an institutional review board, in § 56.122 of this chapter.

(37) Disqualification determination of a nonclinical laboratory, in § 58.213 of this chapter.

(38) Minutes or records regarding a public advisory committee, in § 14.65(c) of this chapter.

(39) Data submitted regarding persons receiving an implanted pacemaker device or lead, in § 805.25 of this chapter.

(40) Humanitarian device exemption application, in § 814.122 of this chapter.

(41) Premarket notifications for food contact substances, in § 170.102 of this chapter.

(42) Registration of food facilities, in § 1.243 of this chapter.

(43) Minor-use or minor-species (MUMS) drug designations, in § 516.52 of this chapter.

(44) Minor-species drug index listings, in § 516.171 of this chapter.

(45) Postmarket notifications of a permanent discontinuance or an interruption in manufacturing of certain drugs or biological products, in §§ 310.306, 314.81(b)(3)(iii), and 600.82 of this chapter.

(46) Generally recognized as safe (GRAS) notices, in part 170, subpart E and part 570, subpart E of this chapter.

(47) Requests to establish or amend import tolerances, in § 510.205 of this chapter.

(48) Status reports of postmarketing study commitments in §§ 314.81(b)(2)(vii)(b) and 601.70(e) of this chapter.

[42 FR 15616, Mar. 22, 1977, as amended at 42 FR 19989, Apr. 15, 1977; 42 FR 42526, Aug. 28, 1977; 42 FR 58889, Nov. 11, 1977; 43 FR 32993, July 28, 1978; 51 FR 22475, June 19, 1986; 54 FR 9038, Mar. 3, 1989; 58 FR 2533, Jan. 6, 1993; 59 FR 536, Jan. 5, 1994; 61 FR 33244, June 26, 1996; 62 FR 40592, July 29, 1997; 64 FR 56448, Oct. 20, 1999; 67 FR 13717, Mar. 26, 2002; 67 FR 35729, May 21, 2002; 68 FR 58965, Oct. 10, 2003; 72 FR 41017, July 26, 2007; 72 FR 69118, Dec. 6, 2007; 80 FR 38938, July 8, 2015; 81 FR 45409, July 14, 2016; 81 FR 55046, Aug. 17, 2016; 81 FR 60212, Aug. 31, 2016; 86 FR 52410, Sept. 21, 2021; 87 FR 55914, Sept. 13, 2022]