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Rule

Change in the Removal of the Office of Management and Budget (OMB) Control Numbers; Technical Amendment

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Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

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.

EFFECTIVE DATE:

March 4, 2002.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

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310, 312, 314, 510, 514, 606, 610, 640, 660, 680, 720, 814, 1020, and 1040 to reflect a change in the removal of the outdated OMB control numbers.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.

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List of Subjects

21 CFR Part 56

  • Human research subjects
  • Reporting and recordkeeping requirements
  • Safety

21 CFR Part 58

  • Laboratories
  • Reporting and recordkeeping requirements

21 CFR Part 60

  • Administrative practice and procedure
  • Drugs
  • Food additives
  • Inventions and patents
  • Medical devices
  • Reporting and recordkeeping requirements

21 CFR Part 101

  • Food labeling
  • Nutrition
  • Reporting and recordkeeping requirements

21 CFR Part 107

  • Food labeling
  • Infants and children
  • Nutrition
  • Reporting and recordkeeping requirements
  • Signs and symbols

21 CFR Part 179

  • Food additives
  • Food labeling
  • Food packaging
  • Radiation protection
  • Reporting and recordkeeping requirements
  • Signs and symbols

21 CFR Part 310

  • Administrative practice and procedure
  • Drugs
  • Labeling
  • Medical devices
  • Reporting and recordkeeping requirements

21 CFR Part 312

  • Drugs
  • Exports
  • Imports
  • Investigations
  • Labeling
  • Medical research
  • Reporting and recordkeeping requirements
  • Safety

21 CFR Part 314

  • Administrative practice and procedure
  • Confidential business information
  • Drugs
  • Reporting and recordkeeping requirements

21 CFR Part 510

  • Administrative practice and procedure
  • Animal drugs
  • Labeling
  • Reporting and recordkeeping requirements

21 CFR Part 514

  • Administrative practice and procedure
  • Animal drugs
  • Confidential business information
  • Reporting and recordkeeping requirements

21 CFR Part 606

  • Blood
  • Labeling
  • Laboratories
  • Reporting and recordkeeping requirements

21 CFR Part 610

  • Biologics
  • Labeling
  • Reporting and recordkeeping requirements

21 CFR Part 640

  • Blood
  • Labeling
  • Reporting and recordkeeping requirements

21 CFR Part 660

  • Biologics
  • Labeling
  • Reporting and recordkeeping requirements

21 CFR Part 680

  • Biologics
  • Blood
  • Reporting and recordkeeping requirements

21 CFR Part 720

  • Confidential business information
  • Cosmetics

21 CFR Part 814

  • Administrative practice and procedure
  • Confidential business information
  • Medical devices
  • Medical research
  • Reporting and recordkeeping requirements

21 CFR Part 1020

  • Electronic products
  • Medical devices
  • Radiation protection
  • Reporting and recordkeeping requirements
  • Television
  • X-rays

21 CFR Part 1040

  • Electronic products
  • Labeling
  • Lasers
  • Medical devices
  • Radiation protection
  • Reporting and recordkeeping requirements
End List of Subjects Start Amendment Part

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:

End Amendment Part Start Part

PART 56—INSTITUTIONAL REVIEW BOARDS

End Part

1. The authority citation for 21 CFR part 56 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-263n.

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2. In § 56.108 IRB functions and operations, remove the parenthetical phrase at the end of the section.

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3. In § 56.115 IRB records, remove the parenthetical phrase at the end of the section.

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PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

End Part

4. The authority citation for 21 CFR part 58 continues to read as follows:

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Authority: 21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 262, 263b-263n.

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[Amended]
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5. In § 58.35 Quality assurance unit, remove the parenthetical phrase at the end of the section.

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[Amended]
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6. In § 58.63 Maintenance and calibration of equipment, remove the parenthetical phrase at the end of the section.

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7. In § 58.90 Animal care, remove the parenthetical phrase at the end of the section.

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8. In § 58.105 Test and control article characterization, remove the parenthetical phrase at the end of the section.

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9. In § 58.120 Protocol, remove the parenthetical phrase at the end of the section.

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10. In § 58.130 Conduct of a nonclinical laboratory study, remove the parenthetical phrase at the end of the section.

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11. In § 58.190 Storage and retrieval of records and data, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 60—PATENT TERM RESTORATION

End Part

12. The authority citation for 21 CFR part 60 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 348, 355, 360e, 360j, 371, 379e; 35 U.S.C. 156; 42 U.S.C. 262.

End Authority
[Amended]
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13. In § 60.24 Revision of regulatory review period determinations, remove the parenthetical phrase at the end of the section.

End Amendment Part
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14. In § 60.30 Filing, format, and content of petitions, remove the parenthetical phrase at the end of the section.

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[Amended]
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15. In § 60.40 Request for hearing, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 101—FOOD LABELING

End Part

16. The authority citation for 21 CFR part 101 continues to read as follows:

Start Authority

Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271.

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[Amended]
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17. In § 101.69 Petitions for nutrient content claims, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 107—INFANT FORMULA

End Part

18. The authority citation for 21 CFR part 107 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 321, 343, 350a, 371.

End Authority
[Amended]
Start Amendment Part

19. In § 107.10 Nutrient information, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

20. In § 107.20 Directions for use, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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21. In § 107.50 Terms and conditions, remove the parenthetical phrase at the end of the section.

End Amendment Part
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22. In § 107.280 Records retention, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 179—IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD

End Part

23. The authority citation for 21 CFR part 179 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 321, 342, 343, 348, 373, 374.

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[Amended]
Start Amendment Part

24. In § 179.25 General provisions for food irradiation, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 310—NEW DRUGS

End Part

25. The authority citation for 21 CFR part 310 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 263b-263n.

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[Amended]
Start Amendment Part

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.

End Amendment Part Start Part

PART 312—INVESTIGATIONAL NEW DRUG APPLICATION

End Part

27. The authority citation for 21 CFR part 312 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 371; 42 U.S.C. 262.

End Authority
[Amended]
Start Amendment Part

28. In § 312.7 Promotion and charging for investigational drugs, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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29. In § 312.10 Waivers, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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30. In § 312.23 IND content and format, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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31. In § 312.30 Protocol amendments, remove the parenthetical phrase at the end of the section.

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[Amended]
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32. In § 312.31 Information amendments, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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33. In § 312.32 IND safety reports, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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34. In § 312.33 Annual reports, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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35. In § 312.35 Submissions for treatment use, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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36. In § 312.36 Emergency use of an investigational new drug, remove the parenthetical phrase at the end of the section.

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37. In § 312.38 Withdrawal of an IND, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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38. In § 312.41 Comment and advice on an IND, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

39. In § 312.44 Termination, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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40. In § 312.45 Inactive status, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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41. In § 312.47 Meetings, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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42. In § 312.53 Selecting investigators and monitors, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

43. In § 312.55 Informing investigators, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

44. In § 312.56 Review of ongoing investigations, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

45. In § 312.57 Recordkeeping and record retention, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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46. In § 312.59 Disposition of unused supply of investigational drug, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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47. In § 312.62 Investigator recordkeeping and record retention, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

48. In § 312.64 Investigator reports, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

49. In § 312.66 Assurance of IRB review, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

50. In § 312.70 Disqualification of a clinical investigator, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

51. In § 312.110 Import and export requirements, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

52. In § 312.120 Foreign clinical studies not conducted under an IND, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

53. In § 312.140 Address for correspondence, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

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.

End Amendment Part Start Part

PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

End Part

55. The authority citation for 21 CFR part 314 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 356, 356a, 356b, 356c, 371, 374, 379e.

End Authority
[Amended]
Start Amendment Part

56. In § 314.50 Content and format of an application, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

57. In § 314.70 Supplements and other changes to an approved application, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

58. In § 314.71 Procedures for submission of a supplement to an approved application, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

59. In § 314.72 Changes in ownership of an application, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

60. In § 314.80 Postmarketing reporting of adverse drug experiences, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

61. In § 314.90 Waivers, remove the parenthetical phrase at the end of the section

End Amendment Part
[Amended]
Start Amendment Part

62. In § 314.126 Adequate and well-controlled studies, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

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.

End Amendment Part
[Amended]
Start Amendment Part

64. In § 314.420 Drug master files, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 510—NEW ANIMAL DRUGS

End Part

65. The authority citation for 21 CFR part 510 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

End Authority
[Amended]
Start Amendment Part

66. In § 510.455 New animal drug requirements regarding free-choice administration in feeds, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 514—NEW ANIMAL DRUG APPLICATIONS

End Part

67. The authority citation for 21 CFR part 514 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 351, 352, 360b, 371, 379e, 381.

End Authority
[Amended]
Start Amendment Part

68. In § 514.1 Applications, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

End Part

69. The authority citation for 21 CFR part 606 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371, 374; 42 U.S.C. 216, 262, 263a, 264.

End Authority
[Amended]
Start Amendment Part

70. In § 606.170 Adverse reaction file, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 610—GENERAL BIOLOGICAL PRODUCTS

End Part

71. The authority citation for 21 CFR part 610 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.

End Authority
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72. In § 610.2 Requests for samples and protocols; official release, remove the parenthetical phrase at the end of the section

End Amendment Part
[Amended]
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73. In § 610.12 Sterility, remove the parenthetical phrase at the end of the section.

End Amendment Part
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74. In § 610.13 Purity, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

75. In § 610.18 Cultures, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS

End Part

76. The authority citation for 21 CFR part 640 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.

End Authority
[Amended]
Start Amendment Part

77. In § 640.2 General requirements, remove the parenthetical phrase at the end of the section

End Amendment Part
[Amended]
Start Amendment Part

78. In § 640.72 Records, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS

End Part

79. The authority citation for 21 CFR part 660 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372; 42 U.S.C. 216, 262, 263, 263a, 264.

End Authority
[Amended]
Start Amendment Part

80. In § 660.21 Processing, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

81. In § 660.22 Potency requirements with reference preparations, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

82. In § 660.25 Potency tests without reference preparations, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

83. In § 660.26 Specificity tests and avidity tests, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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84. In § 660.28 Labeling, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

85. In § 660.34 Processing, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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86. In § 660.35 Labeling, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

87. In § 660.36 Samples and protocols, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

88. In § 660.51 Processing, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

89. In § 660.52 Reference preparations, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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90. In § 660.53 Controls for serological procedures, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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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.

End Amendment Part
[Amended]
Start Amendment Part

92. In § 660.55 Labeling, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 680—ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS

End Part

93. The authority citation for 21 CFR part 680 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.

End Authority
[Amended]
Start Amendment Part

94. In § 680.1 Allergenic products, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
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95. In § 680.2 Manufacture of allergenic products, remove the parenthetical phrase in paragraph (f) of this section.

End Amendment Part
[Amended]
Start Amendment Part

96. In § 680.3 Tests, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 720—VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS

End Part

97. The authority citation for 21 CFR part 720 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 321, 331, 361, 362, 371, 374.

End Authority
[Amended]
Start Amendment Part

98. In § 720.6 Amendments to statement, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES

End Part

99. The authority citation for 21 CFR part 814 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 373, 374, 375, 379, 379e, 381.

End Authority
[Amended]
Start Amendment Part

100. In § 814.20 Application, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

101. In § 814.39 PMA supplements, remove the parenthetical phrase at the end of the section.

End Amendment Part
[Amended]
Start Amendment Part

102. In § 814.84 Reports, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 1020—PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

End Part

103. The authority citation for 21 CFR part 1020 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 351, 352, 360e-360j, 360gg-360ss, 371, 381.

End Authority
[Amended]
Start Amendment Part

104. In § 1020.33 Computed tomography (CT) equipment, remove the parenthetical phrase at the end of the section.

End Amendment Part Start Part

PART 1040—PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

End Part

105. The authority citation for 21 CFR part 1040 continues to read as follows:

Start Authority

Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42 U.S.C. 263b-263n.

End Authority
[Amended]
Start Amendment Part

106. In § 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products, remove the Start Printed Page 9588parenthetical phrase at the end of the section.

End Amendment Part Start Signature

Dated: February 20, 2002.

Margaret M. Dotzel,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 02-4962 Filed 3-1-02; 8:45 am]

BILLING CODE 4160-01-S