[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.100]
[Page 211-212]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20 PUBLIC INFORMATION--Table of Contents
Subpart F Availability of Specific Categories of Records
Sec. 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 Sec. Sec. 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 Sec. 7.87(c) of this chapter.
(2) Flavor ingredient records and notes, in Sec. 101.22(i)(4)(iv)
of this chapter.
(3) Environmental assessments; finding of no significant impact, in
Sec. 25.51 of this chapter, or draft and final environmental impact
statements, in Sec. 25.52 of this chapter.
(4) Color additive petitions, in Sec. 71.15 of this chapter.
(5) Food standard temporary permits, in Sec. 130.17(k) of this
chapter.
(6) Information on thermal processing of low-acid foods packaged in
hermetically sealed containers, in Sec. 108.35(l) of this chapter.
(7) Food additive petitions, in Sec. Sec. 171.1(h) and 571.1(h) of
this chapter.
(8) Action levels for natural and unavoidable defects in food for
human use, in Sec. 110.110(e) of this chapter.
(9) Drug establishment registrations and drug listings, in Sec.
207.37 of this chapter.
(10) Investigational new animal drug notices, in Sec. 514.12 of
this chapter.
(11) New animal drug application files, in Sec. 514.11 of this
chapter.
(12) Investigational new animal drug notice and a new animal drug
application file for an antibiotic drug, in Sec. 514.10 of this
chapter.
(13) Methadone patient records, in Sec. 291.505(g) of this chapter.
(14) Investigational new drug notice, in Sec. 312.130 of this
chapter.
(15) Labeling for and lists of approved new drug applications, in
Sec. 314.430 of this chapter.
(16) Master file for a new drug application, in Sec. 312.420 of
this chapter.
(17) New drug application file, in Sec. 314.430 of this chapter.
(18) Data and information submitted for in vitro diagnostic
products, in Sec. 809.4 of this chapter.
(19) Data and information submitted for OTC drug review, in Sec.
330.10(a)(2) of this chapter.
(20) Investigational new drug notice for an antibiotic drug, in
Sec. 431.70 of this chapter.
(21) Antibiotic drug file, in Sec. 314.430 of this chapter.
(22) Data and information submitted for biologics review, in Sec.
601.25(b)(2) of this chapter.
(23) Investigational new drug notice for a biological product, in
Sec. 601.50 of this chapter.
(24) Applications for biologics licenses for biological products, in
Sec. 601.51 of this chapter.
(25) Cosmetic establishment registrations, in Sec. 710.7 of this
chapter.
[[Page 212]]
(26) Cosmetic product ingredient and cosmetic raw material
composition statements, Sec. 720.8 of this chapter.
(27) Cosmetic product experience reports, in Sec. 730.7 of this
chapter.
(28) Device premarket notification submissions, in Sec. 807.95 of
this chapter.
(29) Electronic product information, in Sec. Sec. 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 Sec. 860.5 of
this chapter.
(31) Data and information submitted in offers to develop a proposed
performance standard for medical devices, in Sec. 861.26 of this
chapter.
(32) Investigational device exemptions in Sec. 812.38 of this
chapter.
(33) Health claims petitions, in Sec. 101.70 of this chapter.
(34) Premarket approval application, in Sec. 814.9 of this chapter.
(35) Report of certain adverse experiences with a medical device, in
Sec. 803.9 of this chapter.
(36) Disqualification determination of an institutional review
board, in Sec. 56.122 of this chapter.
(37) Disqualification determination of a nonclinical laboratory, in
Sec. 58.213 of this chapter.
(38) Minutes or records regarding a public advisory committee, in
Sec. 14.65(c) of this chapter.
(39) Data submitted regarding persons receiving an implanted
pacemaker device or lead, in Sec. 805.25 of this chapter.
(40) Humanitarian device exemption application, in Sec. 814.122 of
this chapter.
(41) Premarket notifications for food contact substances, in Sec.
170.102 of this chapter.
(42) Registration of food facilities, in Sec. 1.243 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]
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