[Federal Register Volume 67, Number 42 (Monday, March 4, 2002)]
[Rules and Regulations]
[Pages 9584-9588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4962]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 56, 58, 60, 101, 107, 179, 310, 312, 314, 510, 514, 
606, 610, 640, 660, 680, 720, 814, 1020, and 1040


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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.

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.

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removal of the outdated OMB control numbers.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.

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.

    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:

PART 56--INSTITUTIONAL REVIEW BOARDS

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

    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.

[[Page 9585]]

Sec. 56.108  [Amended]

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


Sec. 56.115  [Amended]

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

PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY 
STUDIES

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

    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.


Sec. 58.35  [Amended]

    5. In Sec. 58.35 Quality assurance unit, remove the parenthetical 
phrase at the end of the section.


Sec. 58.63  [Amended]

    6. In Sec. 58.63 Maintenance and calibration of equipment, remove 
the parenthetical phrase at the end of the section.


Sec. 58.90  [Amended]

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


Sec. 58.105  [Amended]

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


Sec. 58.120  [Amended]

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


Sec. 58.130  [Amended]

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


Sec. 58.190  [Amended]

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

PART 60--PATENT TERM RESTORATION

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

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


Sec. 60.24  [Amended]

    13. In Sec. 60.24 Revision of regulatory review period 
determinations, remove the parenthetical phrase at the end of the 
section.


Sec. 60.30  [Amended]

    14. In Sec. 60.30 Filing, format, and content of petitions, remove 
the parenthetical phrase at the end of the section.


Sec. 60.40  [Amended]

    15. In Sec. 60.40 Request for hearing, remove the parenthetical 
phrase at the end of the section.

PART 101--FOOD LABELING

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

    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.


Sec. 101.69  [Amended]

    17. In Sec. 101.69 Petitions for nutrient content claims, remove 
the parenthetical phrase at the end of the section.

PART 107--INFANT FORMULA

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

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


Sec. 107.10  [Amended]

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


Sec. 107.20  [Amended]

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


Sec. 107.50  [Amended]

    21. In Sec. 107.50 Terms and conditions, remove the parenthetical 
phrase at the end of the section.


Sec. 107.280  [Amended]

    22. In Sec. 107.280 Records retention, remove the parenthetical 
phrase at the end of the section.

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

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

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


Sec. 179.25  [Amended]

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

PART 310--NEW DRUGS

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

    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.


Sec. 310.305  [Amended]

    26. In Sec. 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.

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

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

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


Sec. 312.7  [Amended]

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


Sec. 312.10  [Amended]

    29. In Sec. 312.10 Waivers, remove the parenthetical phrase at the 
end of the section.


Sec. 312.23  [Amended]

    30. In Sec. 312.23 IND content and format, remove the parenthetical 
phrase at the end of the section.


Sec. 312.30  [Amended]

    31. In Sec. 312.30 Protocol amendments, remove the parenthetical 
phrase at the end of the section.


Sec. 312.31  [Amended]

    32. In Sec. 312.31 Information amendments, remove the parenthetical 
phrase at the end of the section.


Sec. 312.32  [Amended]

    33. In Sec. 312.32 IND safety reports, remove the parenthetical 
phrase at the end of the section.


Sec. 312.33  [Amended]

    34. In Sec. 312.33 Annual reports, remove the parenthetical phrase 
at the end of the section.


Sec. 312.35  [Amended]

    35. In Sec. 312.35 Submissions for treatment use, remove the 
parenthetical phrase at the end of the section.


Sec. 312.36  [Amended]

    36. In Sec. 312.36 Emergency use of an investigational new drug, 
remove the parenthetical phrase at the end of the section.

[[Page 9586]]

Sec. 312.38  [Amended]

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


Sec. 312.41  [Amended]

    38. In Sec. 312.41 Comment and advice on an IND, remove the 
parenthetical phrase at the end of the section.


Sec. 312.44  [Amended]

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


Sec. 312.45  [Amended]

    40. In Sec. 312.45 Inactive status, remove the parenthetical phrase 
at the end of the section.


Sec. 312.47  [Amended]

    41. In Sec. 312.47 Meetings, remove the parenthetical phrase at the 
end of the section.


Sec. 312.53  [Amended]

    42. In Sec. 312.53 Selecting investigators and monitors, remove the 
parenthetical phrase at the end of the section.


Sec. 312.55  [Amended]

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


Sec. 312.56  [Amended]

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


Sec. 312.57  [Amended]

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


Sec. 312.59  [Amended]

    46. In Sec. 312.59 Disposition of unused supply of investigational 
drug, remove the parenthetical phrase at the end of the section.


Sec. 312.62  [Amended]

    47. In Sec. 312.62 Investigator recordkeeping and record retention, 
remove the parenthetical phrase at the end of the section.


Sec. 312.64  [Amended]

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


Sec. 312.66  [Amended]

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


Sec. 312.70  [Amended]

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


Sec. 312.110  [Amended]

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


Sec. 312.120  [Amended]

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


Sec. 312.140  [Amended]

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


Sec. 312.160  [Amended]

    54. In Sec. 312.160 Drugs for investigational use in laboratory 
research animals or in vitro tests, remove the parenthetical phrase at 
the end of the section.

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

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

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


Sec. 314.50  [Amended]

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


Sec. 314.70  [Amended]

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


Sec. 314.71  [Amended]

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


Sec. 314.72  [Amended]

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


Sec. 314.80  [Amended]

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


Sec. 314.90  [Amended]

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


Sec. 314.126  [Amended]

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


Sec. 314.200  [Amended]

    63. In Sec. 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.


Sec. 314.420  [Amended]

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

PART 510--NEW ANIMAL DRUGS

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

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


Sec. 510.455  [Amended]

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

PART 514--NEW ANIMAL DRUG APPLICATIONS

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

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


Sec. 514.1  [Amended]

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

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

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

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


Sec. 606.170  [Amended]

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

PART 610--GENERAL BIOLOGICAL PRODUCTS

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

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

[[Page 9587]]

Sec. 610.2  [Amended]

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


Sec. 610.12  [Amended]

    73. In Sec. 610.12 Sterility, remove the parenthetical phrase at 
the end of the section.


Sec. 610.13  [Amended]

    74. In Sec. 610.13 Purity, remove the parenthetical phrase at the 
end of the section.


Sec. 610.18  [Amended]

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

PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS

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

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


Sec. 640.2  [Amended]

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


Sec. 640.72  [Amended]

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

PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR 
LABORATORY TESTS

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

    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.


Sec. 660.21  [Amended]

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


Sec. 660.22  [Amended]

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


Sec. 660.25  [Amended]

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


Sec. 660.26  [Amended]

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


Sec. 660.28  [Amended]

    84. In Sec. 660.28 Labeling, remove the parenthetical phrase at the 
end of the section.


Sec. 660.34  [Amended]

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


Sec. 660.35  [Amended]

    86. In Sec. 660.35 Labeling, remove the parenthetical phrase at the 
end of the section.


Sec. 660.36  [Amended]

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


Sec. 660.51  [Amended]

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


Sec. 660.52  [Amended]

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


Sec. 660.53  [Amended]

    90. In Sec. 660.53 Controls for serological procedures, remove the 
parenthetical phrase at the end of the section.


Sec. 660.54  [Amended]

    91. In Sec. 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.


Sec. 660.55  [Amended]

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

PART 680--ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS

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

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


Sec. 680.1  [Amended]

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


Sec. 680.2  [Amended]

    95. In Sec. 680.2 Manufacture of allergenic products, remove the 
parenthetical phrase in paragraph (f) of this section.


Sec. 680.3  [Amended]

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

PART 720--VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT 
COMPOSITION STATEMENTS

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

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


Sec. 720.6  [Amended]

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

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

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

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


Sec. 814.20  [Amended]

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


Sec. 814.39  [Amended]

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


Sec. 814.84  [Amended]

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

PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING 
PRODUCTS

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

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


Sec. 1020.33  [Amended]

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

PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

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

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


Sec. 1040.20  [Amended]

    106. In Sec.  1040.20 Sunlamp products and ultraviolet lamps 
intended for use in sunlamp products, remove the

[[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