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Food and Drug Administration, HHS.
Final rule; technical amendment.
The Food and Drug Administration (FDA) is amending its regulations to reflect a change in the removal of OMB control numbers. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.
March 4, 2002.
Peggy Schlosburg, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
FDA is amending its regulations in 21 CFR parts 56, 58, 60, 101, 107, 179, 310, 312, 314, 510, 514, 606, 610, 640, 660, 680, 720, 814, 1020, and 1040 to reflect a change in the removal of the outdated OMB control numbers. We no longer need to publish OMB control numbers in the CFR, because they are now displayed in a separate Federal Register notice announcing OMB approval for the collection of information.
Publication of this document constitutes final action on these changes under the Administrative Procedure Act (5 U.S.C. 553). Notice and public procedure are unnecessary because FDA is merely correcting nonsubstantive errors.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 56, 58, 60, 101, 107, 179, 310, 312, 314, 510, 514, 606, 610, 640, 660, 680, 720, 814, 1020, and 1040 are amended as follows:
1. The authority citation for 21 CFR part 56 continues to read as follows:
2. In § 56.108 IRB functions and operations, remove the parenthetical phrase at the end of the section.
3. In § 56.115 IRB records, remove the parenthetical phrase at the end of the section.
4. The authority citation for 21 CFR part 58 continues to read as follows:
5. In § 58.35 Quality assurance unit, remove the parenthetical phrase at the end of the section.
6. In § 58.63 Maintenance and calibration of equipment, remove the parenthetical phrase at the end of the section.
7. In § 58.90 Animal care, remove the parenthetical phrase at the end of the section.
8. In § 58.105 Test and control article characterization, remove the parenthetical phrase at the end of the section.
9. In § 58.120 Protocol, remove the parenthetical phrase at the end of the section.
10. In § 58.130 Conduct of a nonclinical laboratory study, remove the parenthetical phrase at the end of the section.
11. In § 58.190 Storage and retrieval of records and data, remove the parenthetical phrase at the end of the section.
12. The authority citation for 21 CFR part 60 continues to read as follows:
13. In § 60.24 Revision of regulatory review period determinations, remove the parenthetical phrase at the end of the section.
14. In § 60.30 Filing, format, and content of petitions, remove the parenthetical phrase at the end of the section.
15. In § 60.40 Request for hearing, remove the parenthetical phrase at the end of the section.
16. The authority citation for 21 CFR part 101 continues to read as follows:
17. In § 101.69 Petitions for nutrient content claims, remove the parenthetical phrase at the end of the section.
18. The authority citation for 21 CFR part 107 continues to read as follows:
19. In § 107.10 Nutrient information, remove the parenthetical phrase at the end of the section.
20. In § 107.20 Directions for use, remove the parenthetical phrase at the end of the section.
21. In § 107.50 Terms and conditions, remove the parenthetical phrase at the end of the section.
22. In § 107.280 Records retention, remove the parenthetical phrase at the end of the section.
23. The authority citation for 21 CFR part 179 continues to read as follows:
24. In § 179.25 General provisions for food irradiation, remove the parenthetical phrase at the end of the section.
25. The authority citation for 21 CFR part 310 continues to read as follows:
26. In § 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications, remove the parenthetical phrase at the end of the section.
27. The authority citation for 21 CFR part 312 continues to read as follows:
28. In § 312.7 Promotion and charging for investigational drugs, remove the parenthetical phrase at the end of the section.
29. In § 312.10 Waivers, remove the parenthetical phrase at the end of the section.
30. In § 312.23 IND content and format, remove the parenthetical phrase at the end of the section.
31. In § 312.30 Protocol amendments, remove the parenthetical phrase at the end of the section.
32. In § 312.31 Information amendments, remove the parenthetical phrase at the end of the section.
33. In § 312.32 IND safety reports, remove the parenthetical phrase at the end of the section.
34. In § 312.33 Annual reports, remove the parenthetical phrase at the end of the section.
35. In § 312.35 Submissions for treatment use, remove the parenthetical phrase at the end of the section.
36. In § 312.36 Emergency use of an investigational new drug, remove the parenthetical phrase at the end of the section.
37. In § 312.38 Withdrawal of an IND, remove the parenthetical phrase at the end of the section.
38. In § 312.41 Comment and advice on an IND, remove the parenthetical phrase at the end of the section.
39. In § 312.44 Termination, remove the parenthetical phrase at the end of the section.
40. In § 312.45 Inactive status, remove the parenthetical phrase at the end of the section.
41. In § 312.47 Meetings, remove the parenthetical phrase at the end of the section.
42. In § 312.53 Selecting investigators and monitors, remove the parenthetical phrase at the end of the section.
43. In § 312.55 Informing investigators, remove the parenthetical phrase at the end of the section.
44. In § 312.56 Review of ongoing investigations, remove the parenthetical phrase at the end of the section.
45. In § 312.57 Recordkeeping and record retention, remove the parenthetical phrase at the end of the section.
46. In § 312.59 Disposition of unused supply of investigational drug, remove the parenthetical phrase at the end of the section.
47. In § 312.62 Investigator recordkeeping and record retention, remove the parenthetical phrase at the end of the section.
48. In § 312.64 Investigator reports, remove the parenthetical phrase at the end of the section.
49. In § 312.66 Assurance of IRB review, remove the parenthetical phrase at the end of the section.
50. In § 312.70 Disqualification of a clinical investigator, remove the parenthetical phrase at the end of the section.
51. In § 312.110 Import and export requirements, remove the parenthetical phrase at the end of the section.
52. In § 312.120 Foreign clinical studies not conducted under an IND, remove the parenthetical phrase at the end of the section.
53. In § 312.140 Address for correspondence, remove the parenthetical phrase at the end of the section.
54. In § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests, remove the parenthetical phrase at the end of the section.
55. The authority citation for 21 CFR part 314 continues to read as follows:
56. In § 314.50 Content and format of an application, remove the parenthetical phrase at the end of the section.
57. In § 314.70 Supplements and other changes to an approved application, remove the parenthetical phrase at the end of the section.
58. In § 314.71 Procedures for submission of a supplement to an approved application, remove the parenthetical phrase at the end of the section.
59. In § 314.72 Changes in ownership of an application, remove the parenthetical phrase at the end of the section.
60. In § 314.80 Postmarketing reporting of adverse drug experiences, remove the parenthetical phrase at the end of the section.
61. In § 314.90 Waivers, remove the parenthetical phrase at the end of the section
62. In § 314.126 Adequate and well-controlled studies, remove the parenthetical phrase at the end of the section.
63. In § 314.200 Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing, remove the parenthetical phrase at the end of the section.
64. In § 314.420 Drug master files, remove the parenthetical phrase at the end of the section.
65. The authority citation for 21 CFR part 510 continues to read as follows:
66. In § 510.455 New animal drug requirements regarding free-choice administration in feeds, remove the parenthetical phrase at the end of the section.
67. The authority citation for 21 CFR part 514 continues to read as follows:
68. In § 514.1 Applications, remove the parenthetical phrase at the end of the section.
69. The authority citation for 21 CFR part 606 continues to read as follows:
70. In § 606.170 Adverse reaction file, remove the parenthetical phrase at the end of the section.
71. The authority citation for 21 CFR part 610 continues to read as follows:
72. In § 610.2 Requests for samples and protocols; official release, remove the parenthetical phrase at the end of the section
73. In § 610.12 Sterility, remove the parenthetical phrase at the end of the section.
74. In § 610.13 Purity, remove the parenthetical phrase at the end of the section.
75. In § 610.18 Cultures, remove the parenthetical phrase at the end of the section.
76. The authority citation for 21 CFR part 640 continues to read as follows:
77. In § 640.2 General requirements, remove the parenthetical phrase at the end of the section
78. In § 640.72 Records, remove the parenthetical phrase at the end of the section.
79. The authority citation for 21 CFR part 660 continues to read as follows:
80. In § 660.21 Processing, remove the parenthetical phrase at the end of the section.
81. In § 660.22 Potency requirements with reference preparations, remove the parenthetical phrase at the end of the section.
82. In § 660.25 Potency tests without reference preparations, remove the parenthetical phrase at the end of the section.
83. In § 660.26 Specificity tests and avidity tests, remove the parenthetical phrase at the end of the section.
84. In § 660.28 Labeling, remove the parenthetical phrase at the end of the section.
85. In § 660.34 Processing, remove the parenthetical phrase at the end of the section.
86. In § 660.35 Labeling, remove the parenthetical phrase at the end of the section.
87. In § 660.36 Samples and protocols, remove the parenthetical phrase at the end of the section.
88. In § 660.51 Processing, remove the parenthetical phrase at the end of the section.
89. In § 660.52 Reference preparations, remove the parenthetical phrase at the end of the section.
90. In § 660.53 Controls for serological procedures, remove the parenthetical phrase at the end of the section.
91. In § 660.54 Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties, remove the parenthetical phrase at the end of the section.
92. In § 660.55 Labeling, remove the parenthetical phrase at the end of the section.
93. The authority citation for 21 CFR part 680 continues to read as follows:
94. In § 680.1 Allergenic products, remove the parenthetical phrase at the end of the section.
95. In § 680.2 Manufacture of allergenic products, remove the parenthetical phrase in paragraph (f) of this section.
96. In § 680.3 Tests, remove the parenthetical phrase at the end of the section.
97. The authority citation for 21 CFR part 720 continues to read as follows:
98. In § 720.6 Amendments to statement, remove the parenthetical phrase at the end of the section.
99. The authority citation for 21 CFR part 814 continues to read as follows:
100. In § 814.20 Application, remove the parenthetical phrase at the end of the section.
101. In § 814.39 PMA supplements, remove the parenthetical phrase at the end of the section.
102. In § 814.84 Reports, remove the parenthetical phrase at the end of the section.
103. The authority citation for 21 CFR part 1020 continues to read as follows:
104. In § 1020.33 Computed tomography (CT) equipment, remove the parenthetical phrase at the end of the section.
105. The authority citation for 21 CFR part 1040 continues to read as follows:
106. In § 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products, remove the ( printed page 9588) parenthetical phrase at the end of the section.
Dated: February 20, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-4962 Filed 3-1-02; 8:45 am]
BILLING CODE 4160-01-S