[Federal Register Volume 62, Number 190 (Wednesday, October 1, 1997)]
[Rules and Regulations]
[Pages 51512-51521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25668]
[[Page 51511]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Chapter I
Code of Federal Regulations; Authority Citations; Final Rule
Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 /
Rules and Regulations
[[Page 51512]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. 97N-0365]
Code of Federal Regulations; Authority Citations
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is revising the
authority citations for Title 21, Chapter I of the Code of Federal
Regulations to conform with procedures of the Administrative Committee
of the Federal Register. This action is intended to simplify FDA's
authority citations. It does not represent a change in agency policy
and does not increase any burdens on the public.
DATES: Effective October 1, 1997. Submit written comments by December
30, 1997.
ADDRESSES: Written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy
(HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-443-2994.
SUPPLEMENTARY INFORMATION: The Office of the Federal Register, in
accordance with the procedures of the Administrative Committee of the
Federal Register (1 CFR 21.52), has recommended that each citation of
authority for Chapter I of Title 21 of the Code of Federal Regulations
include only references to the United States Code. Therefore, FDA is
revising the authority citations for 21 CFR parts 1 through 1270 to
conform with these procedures. This action is intended to simplify
FDA's authority citations.
FDA has determined that this final rule does not change the
statutory authority applicable to the regulations issued by FDA.
Because the changes that the agency is making are not substantive and
are merely ministerial changes to the Code of Federal Regulations, the
Commissioner of Food and Drugs finds that there is good cause not to
engage in notice and public comment procedures or to delay the
effective date of these amendments. FDA is merely conforming to the
recommendation of the Office of the Federal Register under 1 CFR 21.51
and 21.52.
Although this rule is effective immediately, the agency is
providing until December 30, 1997, to determine whether the regulation
should be subsequently modified or revoked in accordance with 21 CFR
10.40(e)(1). Interested persons may submit written comments to the
Dockets Management Branch (address above). Two copies of any comments
are to be submitted, except that individuals may submit one copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
office above between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.30(i) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, Chapter I of
Title 21 of the Code of Federal Regulations is amended as follows:
PART 1--GENERAL ENFORCEMENT REGULATIONS
1. The authority citation for 21 CFR part 1 is revised to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 343, 352,
355, 360b, 362, 371; 42 U.S.C. 216.
PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
2. The authority citation for 21 CFR part 2 is revised to read as
follows:
Authority: 21 U.S.C. 321, 331, 335, 342, 346a, 348, 351, 352,
355, 357, 360b, 361, 371, 372, 374; 15 U.S.C. 402, 409.
PART 3--PRODUCT JURISDICTION
3. The authority citation for 21 CFR part 3 is revised to read as
follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 356, 357, 360,
360c-360f, 360h-360j, 360gg-360ss, 371(a), 379e, 381, 394; 42 U.S.C.
216, 262.
PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION
4. The authority citation for 21 CFR part 5 is revised to read as
follows:
Authority: 5 U.S.C. 504, 552, App. 2; 7 U.S.C. 138a, 2271; 15
U.S.C. 638, 1261-1282, 3701-3711a; 15 U.S.C. 1451-1461; 21 U.S.C.
41-50, 61-63, 141-149, 321-394, 467f, 679(b), 801-886, 1031-1309; 35
U.S.C. 156; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263,
264, 265, 300u-300u-5, 300aa-1; 1395y, 3246b, 4332, 4831(a), 10007-
10008; E.O. 11921, 41 FR 24294, 3 CFR, 1977 Comp., p. 124-131; E.O.
12591, 52 FR 13414, 3 CFR, 1988 Comp., p. 220-223.
PART 7--ENFORCEMENT POLICY
5. The authority citation for 21 CFR part 7 is revised to read as
follows:
Authority: 21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n,
264.
PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES
6. The authority citation for 21 CFR part 10 is revised to read as
follows:
Authority: 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821,
1034; 42 U.S.C. 201, 262, 263b, 264; 15 U.S.C. 1451-1461; 5 U.S.C.
551-558, 701-721; 28 U.S.C. 2112.
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
7. The authority citation for 21 CFR part 11 is revised to read as
follows:
Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.
PART 12--FORMAL EVIDENTIARY PUBLIC HEARING
8. The authority citation for 21 CFR part 12 is revised to read as
follows:
Authority: 21 U.S.C. 41-50, 141-149, 321-393, 467f, 679, 821,
1034; 42 U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5
U.S.C. 551-558, 701-721; 28 U.S.C. 2112.
PART 13--PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
9. The authority citation for 21 CFR part 13 is revised to read as
follows:
Authority: 21 U.S.C. 41-50, 141-149, 321-393, 467f, 679, 821,
1034; 42 U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5
U.S.C. 551-558, 701-721; 28 U.S.C. 2112.
PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
10. The authority citation for 21 CFR part 14 is revised to read as
follows:
Authority: 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821,
1034; 42 U.S.C. 201, 262, 263b, 264; 15 U.S.C. 1451-1461; 5 U.S.C.
App. 2; 28 U.S.C. 2112.
PART 15--PUBLIC HEARING BEFORE THE COMMISSIONER
11. The authority citation for 21 CFR part 15 is revised to read as
follows:
Authority: 21 U.S.C. 41-50, 141-149, 321-393, 467f, 679, 821,
1034; 42 U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5
U.S.C. 553; 28 U.S.C. 2112.
[[Page 51513]]
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
12. The authority citation for 21 CFR part 16 is revised to read as
follows:
Authority: 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821,
1034; 42 U.S.C. 201, 262, 264; 15 U.S.C. 1451-1461; 28 U.S.C. 2112.
PART 17--CIVIL MONEY PENALTIES HEARINGS
13. The authority citation for 21 CFR part 17 is revised to read as
follows:
Authority: 21 U.S.C. 331, 333, 337, 351, 352, 355, 360, 360c,
360f, 360i, 360j, 371; 42 U.S.C. 262, 263b, 300aa-28; 5 U.S.C. 554,
555, 556, 557.
PART 19--STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
14. The authority citation for 21 CFR part 19 is revised to read as
follows:
Authority: 21 U.S.C. 371.
PART 20--PUBLIC INFORMATION
15. The authority citation for 21 CFR part 20 is revised to read as
follows:
Authority: 21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242,
242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300-5,
300aa-1; 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582.
PART 21--PROTECTION OF PRIVACY
16. The authority citation for 21 CFR part 21 is revised to read as
follows:
Authority: 21 U.S.C. 371; 5 U.S.C. 552, 552a.
PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS
17. The authority citation for 21 CFR part 25 is revised to read as
follows:
Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C.
4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR,
1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR,
1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980
Comp., p. 356-360.
PART 50--PROTECTION OF HUMAN SUBJECTS
18. The authority citation for 21 CFR part 50 is revised to read as
follows:
Authority: 21 U.S.C. 321, 346, 346a, 348, 352, 353, 355, 356,
357, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241,
262, 263b-263n.
PART 56--INSTITUTIONAL REVIEW BOARDS
19. The authority citation for 21 CFR part 56 is revised to read as
follows:
Authority: 21 U.S.C. 321, 346, 346a, 348, 351, 352, 353, 355,
356, 357, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216,
241, 262, 263b-263n.
PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY
STUDIES
20. The authority citation for 21 CFR part 58 is revised to read as
follows:
Authority: 21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355,
356, 357, 360, 360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216,
262, 263b-263n.
PART 60--PATENT TERM RESTORATION
21. The authority citation for 21 CFR part 60 is revised to read as
follows:
Authority: 21 U.S.C. 348, 355, 357, 360e, 360j, 371, 379e; 35
U.S.C. 156; 42 U.S.C. 262.
PART 70--COLOR ADDITIVES
22. The authority citation for 21 CFR part 70 is revised to read as
follows:
Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 360b, 361,
371, 379e.
PART 71--COLOR ADDITIVE PETITIONS
23. The authority citation for 21 CFR part 71 is revised to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 351, 355, 356, 357, 360,
360b-360f, 360h-360j, 361, 371, 379e, 381; 42 U.S.C. 216, 262.
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
24. The authority citation for 21 CFR part 73 is revised to read as
follows:
Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.
PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
25. The authority citation for 21 CFR part 74 is revised to read as
follows:
Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.
PART 80--COLOR ADDITIVE CERTIFICATION
26. The authority citation for 21 CFR part 80 is revised to read as
follows:
Authority: 21 U.S.C. 371, 379e.
PART 81--GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR
PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
27. The authority citation for 21 CFR part 81 is revised to read as
follows:
Authority: 21 U.S.C. 371, 379e, 379e note.
PART 82--LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND
SPECIFICATIONS
28. The authority citation for 21 CFR part 82 is revised to read as
follows:
Authority: 21 U.S.C. 371, 379e, 379e note.
PART 100--GENERAL
29. The authority citation for 21 CFR part 100 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 337, 342, 343, 348, 371.
PART 101--FOOD LABELING
30. The authority citation for 21 CFR part 101 is revised to read
as follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371).
PART 102--COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS
31. The authority citation for 21 CFR part 102 is revised to read
as follows:
Authority: 21 U.S.C. 321, 343, 371.
PART 105--FOODS FOR SPECIAL DIETARY USE
32. The authority citation for 21 CFR part 105 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 350, 371, 379e.
PART 106--INFANT FORMULA QUALITY CONTROL PROCEDURES
33. The authority citation for 21 CFR part 106 is revised to read
as follows:
Authority: 21 U.S.C. 321, 350a, 371.
PART 107--INFANT FORMULA
34. The authority citation for 21 CFR part 107 is revised to read
as follows:
Authority: 21 U.S.C. 321, 343, 350a, 371.
PART 108--EMERGENCY PERMIT CONTROL
35. The authority citation for 21 CFR part 108 is revised to read
as follows:
Authority: 21 U.S.C. 342, 344, 371.
[[Page 51514]]
PART 109--UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION
AND FOOD-PACKAGING MATERIAL
36. The authority citation for 21 CFR part 109 is revised to read
as follows:
Authority: 21 U.S.C. 321, 336, 342, 346, 346a, 348, 371.
PART 110--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,
PACKING, OR HOLDING HUMAN FOOD
37. The authority citation for 21 CFR part 110 is revised to read
as follows:
Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.
PART 111--CURRENT GOOD MANUFACTURING PRACTICE FOR DIETARY
SUPPLEMENTS
38. The authority citation for 21 CFR part 111 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 371.
PART 113--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN
HERMETICALLY SEALED CONTAINERS
39. The authority citation for 21 CFR part 113 is revised to read
as follows:
Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.
PART 114--ACIDIFIED FOODS
40. The authority citation for 21 CFR part 114 is revised to read
as follows:
Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.
PART 123--FISH AND FISHERY PRODUCTS
41. The authority citation for 21 CFR part 123 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e,
381, 393; 42 U.S.C. 241, 242l, 264.
PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER
42. The authority citation for 21 CFR part 129 is revised to read
as follows:
Authority: 21 U.S.C. 342, 348, 371, 374; 42 U.S.C. 264.
PART 130--FOOD STANDARDS: GENERAL
43. The authority citation for 21 CFR part 130 is revised to read
as follows:
Authority: 21 U.S.C. 321, 336, 341, 343, 371.
PART 131--MILK AND CREAM
44. The authority citation for 21 CFR part 131 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 133--CHEESES AND RELATED CHEESE PRODUCTS
45. The authority citation for 21 CFR part 133 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 135--FROZEN DESSERTS
46. The authority citation for 21 CFR part 135 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 136--BAKERY PRODUCTS
47. The authority citation for 21 CFR part 136 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 137--CEREAL FLOURS AND RELATED PRODUCTS
48. The authority citation for 21 CFR part 137 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 139--MACARONI AND NOODLE PRODUCTS
49. The authority citation for 21 CFR part 139 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 145--CANNED FRUITS
50. The authority citation for 21 CFR part 145 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 146--CANNED FRUIT JUICES
51. The authority citation for 21 CFR part 146 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 150--FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS
52. The authority citation for 21 CFR part 150 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 152--FRUIT PIES
53. The authority citation for 21 CFR part 152 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 155--CANNED VEGETABLES
54. The authority citation for 21 CFR part 155 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 156--VEGETABLE JUICES
55. The authority citation for 21 CFR part 156 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371.
PART 158--FROZEN VEGETABLES
56. The authority citation for 21 CFR part 158 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371.
PART 160--EGGS AND EGG PRODUCTS
57. The authority citation for 21 CFR part 160 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 161--FISH AND SHELLFISH
58. The authority citation for 21 CFR part 161 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 163--CACAO PRODUCTS
59. The authority citation for 21 CFR part 163 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 341, 343, 348, 371, 379e.
PART 164--TREE NUT AND PEANUT PRODUCTS
60. The authority citation for 21 CFR part 164 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 165--BEVERAGES
61. The authority citation for 21 CFR part 165 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e.
[[Page 51515]]
PART 166--MARGARINE
62. The authority citation for 21 CFR part 166 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 347, 348, 371, 379e.
PART 168--SWEETENERS AND TABLE SIRUPS
63. The authority citation for 21 CFR part 168 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 169--FOOD DRESSINGS AND FLAVORINGS
64. The authority citation for 21 CFR part 169 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
PART 170--FOOD ADDITIVES
65. The authority citation for 21 CFR part 170 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.
PART 171--FOOD ADDITIVE PETITIONS
66. The authority citation for 21 CFR part 171 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR
HUMAN CONSUMPTION
67. The authority citation for 21 CFR part 172 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.
PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR
HUMAN CONSUMPTION
68. The authority citation for 21 CFR part 173 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 348.
PART 174--INDIRECT FOOD ADDITIVES: GENERAL
69. The authority citation for 21 CFR part 174 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF
COATINGS
70. The authority citation for 21 CFR part 175 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
71. The authority citation for 21 CFR part 176 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 346, 348, 379e.
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS
72. The authority citation for 21 CFR part 177 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS
73. The authority citation for 21 CFR part 178 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF
FOOD
74. The authority citation for 21 CFR part 179 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 343, 348, 373, 374.
PART 180--FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD
ON AN INTERIM BASIS PENDING ADDITIONAL STUDY
75. The authority citation for 21 CFR part 180 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 343, 348, 371; 42 U.S.C. 241.
PART 181--PRIOR-SANCTIONED FOOD INGREDIENTS
76. The authority citation for 21 CFR part 181 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
PART 182--SUBSTANCES GENERALLY RECOGNIZED AS SAFE
77. The authority citation for 21 CFR part 182 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED
AS SAFE
78. The authority citation for 21 CFR part 184 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED
AS SAFE
79. The authority citation for 21 CFR part 186 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
80. The authority citation for 21 CFR part 189 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
PART 200--GENERAL
81. The authority citation for 21 CFR part 200 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357,
358, 360e, 371, 374, 375.
PART 201--LABELING
82. The authority citation for 21 CFR part 201 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357,
358, 360, 360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241,
262, 264.
PART 202--PRESCRIPTION DRUG ADVERTISING
83. The authority citation for 21 CFR part 202 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 352, 355, 357, 360b, 371.
PART 205--GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION
DRUG DISTRIBUTORS
84. The authority citation for 21 CFR part 205 is revised to read
as follows:
Authority: 21 U.S.C. 351, 352, 353, 371, 374.
PART 206--IMPRINTING OF SOLID ORAL DOSAGE FROM DRUG PRODUCTS FOR
HUMAN USE
85. The authority citation for 21 CFR part 206 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 357, 371; 42
U.S.C. 262.
PART 207--REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS
IN COMMERCIAL DISTRIBUTION
86. The authority citation for 21 CFR part 207 is revised to read
as follows:
Authority: 21 U.S.C. 331, 351, 352, 355, 356, 357, 360, 360b,
371, 374; 42 U.S.C. 262.
[[Page 51516]]
PART 210--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,
PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
87. The authority citation for 21 CFR part 210 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 355, 356, 357, 360b, 371,
374.
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED
PHARMACEUTICALS
88. The authority citation for 21 CFR part 211 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 355, 356, 357, 360b, 371,
374.
PART 225--CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
89. The authority citation for 21 CFR part 225 is revised to read
as follows:
Authority: 21 U.S.C. 351, 352, 360b, 371, 374.
PART 226--CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED
ARTICLES
90. The authority citation for 21 CFR part 226 is revised to read
as follows:
Authority: 21 U.S.C. 351, 352, 360b, 371, 374.
PART 250--SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
91. The authority citation for 21 CFR part 250 is revised to read
as follows:
Authority: 21 U.S.C. 321, 336, 342, 352, 353, 355, 361(a),
362(a) and (c), 371, 375(b).
PART 290--CONTROLLED DRUGS
92. The authority citation for 21 CFR part 290 is revised to read
as follows:
Authority: 21 U.S.C. 352, 353, 355, 371.
PART 291--DRUGS USED FOR TREATMENT OF NARCOTIC ADDICTS
93. The authority citation for 21 CFR part 291 is revised to read
as follows:
Authority: 21 U.S.C. 355, 371, 823; 42 U.S.C. 241(d), 257a,
290ee-3, 300y-11.
PART 299--DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES
94. The authority citation for 21 CFR part 299 is revised to read
as follows:
Authority: 21 U.S.C. 331, 351, 352, 355, 358, 360b, 371.
PART 300--GENERAL
95. The authority citation for 21 CFR part 300 is revised to read
as follows:
Authority: 21 U.S.C. 331, 351, 352, 355, 357, 360b, 361, 371.
PART 310--NEW DRUGS
96. The authority citation for 21 CFR part 310 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357,
360b-360f, 360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241,
242(a), 262, 263b-263n.
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION
97. The authority citation for 21 CFR part 312 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357,
371; 42 U.S.C. 262.
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG OR AN
ANTIBIOTIC DRUG
98. The authority citation for 21 CFR part 314 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357,
371, 374, 379e.
PART 316--ORPHAN DRUGS
99. The authority citation for 21 CFR part 316 is revised to read
as follows:
Authority: 21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.
PART 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
100. The authority citation for 21 CFR part 320 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 355, 357, 371.
PART 329--HABIT-FORMING DRUGS
101. The authority citation for 21 CFR part 329 is revised to read
as follows:
Authority: 21 U.S.C. 352, 353, 355, 371.
PART 330--OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY
RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
102. The authority citation for 21 CFR part 330 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
PART 331--ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
103. The authority citation for 21 CFR part 331 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
PART 332--ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
104. The authority citation for 21 CFR part 332 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
PART 333--TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE
105. The authority citation for 21 CFR part 333 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371, unless
otherwise noted.
PART 336--ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
106. The authority citation for 21 CFR part 336 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
PART 338--NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE
107. The authority citation for 21 CFR part 338 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
PART 340--STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
108. The authority citation for 21 CFR part 340 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
PART 341--COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC
DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
109. The authority citation for 21 CFR part 341 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
[[Page 51517]]
PART 344--TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
110. The authority citation for 21 CFR part 344 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
PART 346--ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
111. The authority citation for 21 CFR part 346 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
PART 347--SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN
USE
112. The authority citation for 21 CFR part 347 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
PART 348--EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE
113. The authority citation for 21 CFR part 348 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
PART 349--OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
114. The authority citation for 21 CFR part 349 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
PART 355--ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
115. The authority citation for 21 CFR part 355 is revised to read
as follows;
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
PART 357--MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE
116. The authority citation for 21 CFR part 357 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
PART 358--MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE
117. The authority citation for 21 CFR part 358 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
PART 361--PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS
SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
118. The authority citation for 21 CFR part 361 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 371; 42 U.S.C.
262.
PART 369--INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND
DEVICES FOR OVER-THE-COUNTER SALE
119. The authority citation for 21 CFR part 369 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357,
371.
PART 429--DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN
120. The authority citation for 21 CFR part 429 is revised to read
as follows:
Authority: 21 U.S.C. 352, 356, 371.
PART 430--ANTIBIOTIC DRUGS; GENERAL
121. The authority citation for 21 CFR part 430 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 357, 371; 42
U.S.C. 216, 241, 262.
PART 431--CERTIFICATION OF ANTIBIOTIC DRUGS
122. The authority citation for 21 CFR part 431 is revised to read
as follows:
Authority: 21 U.S.C. 351, 352, 353, 355, 357, 379e; 42 U.S.C.
216, 241, 262; 5 U.S.C. 552.
PART 432--PACKAGING AND LABELING OF ANTIBIOTIC DRUGS
123. The authority citation for 21 CFR part 432 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 352, 353, 357, 371, 381.
PART 433--EXEMPTIONS FROM ANTIBIOTIC CERTIFICATION AND LABELING
REQUIREMENTS
124. The authority citation for 21 CFR part 433 is revised to read
as follows:
Authority: 21 U.S.C. 352, 355, 357.
PART 436--TESTS AND METHODS OF ASSAY OF ANTIBIOTIC AND ANTIBIOTIC-
CONTAINING DRUGS
125. The authority citation for 21 CFR part 436 is revised to read
as follows:
Authority: 21 U.S.C. 357.
PART 440--PENICILLIN ANTIBIOTIC DRUGS
126. The authority citation for 21 CFR part 440 is revised to read
as follows:
Authority: 21 U.S.C. 357.
PART 441--PENEM ANTIBIOTIC DRUGS
127. The authority citation for 21 CFR part 441 is revised to read
as follows:
Authority: 21 U.S.C. 357.
PART 442--CEPHA ANTIBIOTIC DRUGS
128. The authority citation for 21 CFR part 442 is revised to read
as follows:
Authority: 21 U.S.C. 357.
PART 443--CARBACEPHEM ANTIBIOTIC DRUGS
129. The authority citation for 21 CFR part 443 is revised to read
as follows:
Authority: 21 U.S.C. 357.
PART 444--OLIGOSACCHARIDE ANTIBIOTIC DRUGS
130. The authority citation for 21 CFR part 444 is revised to read
as follows:
Authority: 21 U.S.C. 357.
PART 446--TETRACYCLINE ANTIBIOTIC DRUGS
131. The authority citation for 21 CFR part 446 is revised to read
as follows:
Authority: 21 U.S.C. 357.
PART 448--PEPTIDE ANTIBIOTIC DRUGS
132. The authority citation for 21 CFR part 448 is revised to read
as follows:
Authority: 21 U.S.C. 357.
PART 449--ANTIFUNGAL ANTIBIOTIC DRUGS
133. The authority citation for 21 CFR part 449 is revised to read
as follows:
Authority: 21 U.S.C. 357.
[[Page 51518]]
PART 450--ANTITUMOR ANTIBIOTIC DRUGS
134. The authority citation for 21 CFR part 450 is revised to read
as follows:
Authority: 21 U.S.C. 357.
PART 452--MACROLIDE ANTIBIOTIC DRUGS
135. The authority citation for 21 CFR part 452 is revised to read
as follows:
Authority: 21 U.S.C. 357.
PART 453--LINCOMYCIN ANTIBIOTIC DRUGS
136. The authority citation for 21 CFR part 453 is revised to read
as follows:
Authority: 21 U.S.C. 357.
PART 455--CERTAIN OTHER ANTIBIOTICS DRUGS
137. The authority citation for 21 CFR part 455 is revised to read
as follows:
Authority: 21 U.S.C. 357.
PART 460--ANTIBIOTICS DRUGS INTENDED FOR USE IN LABORATORY
DIAGNOSIS OF DISEASE
138. The authority citation for 21 CFR part 460 is revised to read
as follows:
Authority: 21 U.S.C. 357.
PART 500--GENERAL
139. The authority citation for 21 CFR part 500 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353,
360b, 371.
PART 501--ANIMAL FOOD LABELING
140. The authority citation for 21 CFR part 501 is revised to read
as follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371.
PART 502--COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS
141. The authority citation for 21 CFR part 502 is revised to read
as follows:
Authority: 21 U.S.C. 321, 343, 371.
PART 509--UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-
PACKAGING MATERIAL
142. The authority citation for 21 CFR part 509 is revised to read
as follows:
Authority: 21 U.S.C. 336, 342, 346, 346a, 348, 371.
PART 510--NEW ANIMAL DRUGS
143. The authority citation for 21 CFR part 510 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
PART 511--NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE
144. The authority citation for 21 CFR part 511 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 360b, 371.
PART 514--NEW ANIMAL DRUG APPLICATIONS
145. The authority citation for 21 CFR part 514 is revised to read
as follows:
Authority: 21 U.S.C. 351, 352, 360b, 371, 379e, 381.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
146. The authority citation for 21 CFR part 520 is revised to read
as follows:
Authority: 21 U.S.C. 360b.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
147. The authority citation for 21 CFR part 522 is revised to read
as follows:
Authority: 21 U.S.C. 360b.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
148. The authority citation for 21 CFR part 524 is revised to read
as follows:
Authority: 21 U.S.C. 360b.
PART 526--INTRAMAMMARY DOSAGE FORMS
149. The authority citation for 21 CFR part 526 is revised to read
as follows:
Authority: 21 U.S.C. 360b.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
150. The authority citation for 21 CFR part 529 is revised to read
as follows:
Authority: 21 U.S.C. 360b.
PART 530--EXTRALABEL DRUG USE IN ANIMALS
151. The authority citation for 21 CFR part 530 is revised to read
as follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 351,
352, 353, 355, 357, 360b, 371, 379e.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
152. The authority citation for 21 CFR part 556 is revised to read
as follows:
Authority: 21 U.S.C. 342, 360b, 371.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
153. The authority citation for 21 CFR part 558 is revised to read
as follows:
Authority: 21 U.S.C. 360b, 371.
PART 564--DEFINITIONS AND STANDARDS FOR ANIMAL FOOD
154. The authority citation for 21 CFR part 564 is revised to read
as follows:
Authority: 21 U.S.C. 341, 343, 371.
PART 570--FOOD ADDITIVES
155. The authority citation for 21 CFR part 570 is revised to read
as follows:
Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.
PART 571--FOOD ADDITIVE PETITIONS
156. The authority citation for 21 CFR part 571 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 348, 371; 42 U.S.C. 241.
PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS
157. The authority citation for 21 CFR part 573 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 348.
PART 579--IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING
OF ANIMAL FEED AND PET FOOD
158. The authority citation for 21 CFR part 579 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 343, 348, 371.
PART 582--SUBSTANCES GENERALLY RECOGNIZED AS SAFE
159. The authority citation for 21 CFR part 582 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
PART 584--FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
IN FEED AND DRINKING WATER OF ANIMALS
160. The authority citation for 21 CFR part 584 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
[[Page 51519]]
PART 589--SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
161. The authority citation for 21 CFR part 589 is revised to read
as follows:
Authority: 21 U.S.C. 321, 342, 343, 348, 371.
PART 600--BIOLOGICAL PRODUCTS: GENERAL
162. The authority citation for 21 CFR part 600 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 360i, 371,
374; 42 U.S.C. 216, 262, 263, 263a, 264, 300aa-25.
PART 601--LICENSING
163. The authority citation for 21 CFR part 601 is revised to read
as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 360c-360f,
360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263; 15
U.S.C. 1451-1561.
PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD
COMPONENTS
164. The authority citation for 21 CFR part 606 is revised 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.
PART 607--ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR
MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
165. The authority citation for 21 CFR part 607 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371, 374; 42
U.S.C. 216, 262.
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS
166. The authority citation for 21 CFR part 610 is revised 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.
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
167. The authority citation for 21 CFR part 640 is revised 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.
PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR
LABORATORY TESTS
168. The authority citation for 21 CFR part 660 is revised 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.
PART 680--ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS
169. The authority citation for 21 CFR part 680 is revised 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.
PART 700--GENERAL
170. The authority citation for 21 CFR part 700 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 352, 355, 361, 362, 371, 374.
PART 701--COSMETIC LABELING
171. The authority citation for 21 CFR part 701 is revised to read
as follows:
Authority: 21 U.S.C. 321, 352, 361, 362, 363, 371, 374; 15
U.S.C. 1454, 1455.
PART 710--VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS
172. The authority citation for 21 CFR part 710 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 361, 362, 371, 374.
PART 720--VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT AND
COSMETIC RAW MATERIAL COMPOSITION STATEMENTS
173. The authority citation for 21 CFR part 720 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 361, 362, 371, 374.
PART 730--VOLUNTARY FILING OF COSMETIC PRODUCT EXPERIENCES
174. The authority citation for 21 CFR part 730 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 361, 362, 371, 374.
PART 740--COSMETIC PRODUCT WARNING STATEMENTS
175. The authority citation for 21 CFR part 740 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 352, 355, 361, 362, 371, 374.
PART 800--GENERAL
176. The authority citation for 21 CFR part 800 is revised to read
as follows:
Authority: 21 U.S.C. 321, 334, 351, 352, 355, 356, 357, 360e,
360i, 360k, 361, 362, 371.
PART 801--LABELING
177. The authority citation for 21 CFR part 801 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 357, 360i, 360j, 371,
374.
PART 803--MEDICAL DEVICE REPORTING
178. The authority citation for 21 CFR part 803 is revised to read
as follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
PART 804--MEDICAL DEVICE DISTRIBUTOR REPORTING
179. The authority citation for 21 CFR part 804 is revised to read
as follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
PART 805--CARDIAC PACEMAKER REGISTRY
180. The authority citation for 21 CFR part 805 is revised to read
as follows:
Authority: 42 U.S.C. 1395y(h), 1395y note.
PART 806--MEDICAL DEVICE CORRECTIONS AND REMOVALS
181. The authority citation for 21 CFR part 806 is revised to read
as follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND DISTRIBUTORS OF DEVICES
182. The authority citation for 21 CFR part 807 is revised to read
as follows:
Authority: 21 U.S.C. 331, 351, 352, 360, 360c, 360e, 360i, 360j,
371, 374.
PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL
MEDICAL DEVICE REQUIREMENTS
183. The authority citation for 21 CFR part 808 is revised to read
as follows:
Authority: 21 U.S.C. 360j, 360k, 371.
[[Page 51520]]
PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
184. The authority citation for 21 CFR part 809 is revised to read
as follows:
Authority: 21 U.S.C. 331, 351, 352, 355, 357, 360b, 360c, 360d,
360h, 360i, 360j, 371, 372, 374, 381.
PART 810--MEDICAL DEVICE RECALL AUTHORITY
185. The authority citation for 21 CFR part 810 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 332, 333, 334, 351, 352, 360h,
371, 374, 375.
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS
186. The authority citation for 21 CFR part 812 is revised to read
as follows:
Authority: 21 U.S.C. 331, 351, 352, 353, 355, 356, 357, 360,
360c-360f, 360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C.
216, 241, 262, 263b-263n.
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
187. The authority citation for 21 CFR part 814 is revised to read
as follows:
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372,
373, 374, 375, 379, 379e, 381.
PART 820--QUALITY SYSTEM REGULATION
188. The authority citation for 21 CFR part 820 is revised to read
as follows:
Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h,
360i, 360j, 360l, 371, 374, 381, 383.
PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS
189. The authority citation for 21 CFR part 821 is revised to read
as follows:
Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371,
374.
PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES
190. The authority citation for 21 CFR part 860 is revised to read
as follows:
Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.
PART 861--PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
191. The authority citation for 21 CFR part 861 is revised to read
as follows:
Authority: 21 U.S.C. 351, 352, 360c, 360d, 360gg-360ss, 371,
374; 42 U.S.C. 262, 264.
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
192. The authority citation for 21 CFR part 862 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES
193. The authority citation for 21 CFR part 864 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
194. The authority citation for 21 CFR part 866 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
PART 868--ANESTHESIOLOGY DEVICES
195. The authority citation for 21 CFR part 868 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
PART 870--CARDIOVASCULAR DEVICES
196. The authority citation for 21 CFR part 870 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
PART 872--DENTAL DEVICES
197. The authority citation for 21 CFR part 872 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
PART 874--EAR, NOSE, AND THROAT DEVICES
198. The authority citation for 21 CFR part 874 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
199. The authority citation for 21 CFR part 876 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
200. The authority citation for 21 CFR part 878 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
201. The authority citation for 21 CFR part 880 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
PART 882--NEUROLOGICAL DEVICES
202. The authority citation for 21 CFR part 882 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
203. The authority citation for 21 CFR part 884 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
PART 886--OPHTHALMIC DEVICES
204. The authority citation for 21 CFR part 886 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
PART 888--ORTHOPEDIC DEVICES
205. The authority citation for 21 CFR part 888 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
PART 890--PHYSICAL MEDICINE DEVICES
206. The authority citation for 21 CFR part 890 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
PART 892--RADIOLOGY DEVICES
207. The authority citation for 21 CFR part 892 is revised to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
PART 895--BANNED DEVICES
208. The authority citation for 21 CFR part 895 is revised to read
as follows:
Authority: 21 U.S.C. 352, 360f, 360h, 360i, 371.
PART 897--CIGARETTES AND SMOKELESS TOBACCO
209. The authority citation for 21 CFR part 897 is revised to read
as follows:
Authority: 21 U.S.C. 352, 360, 360h, 360i, 360j, 371, 374, 393.
[[Page 51521]]
PART 898--PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT
CABLES
210. The authority citation for 21 CFR part 898 is revised to read
as follows:
Authority: 21 U.S.C. 351, 352, 360c, 360d, 360gg-360ss, 371,
374; 42 U.S.C. 262, 264.
PART 900--MAMMOGRAPHY
211. The authority citation for 21 CFR part 900 is revised to read
as follows:
Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.
PART 1000--GENERAL
212. The authority citation for 21 CFR part 1000 is revised to read
as follows:
Authority: 21 U.S.C. 360hh-360ss.
PART 1002--RECORDS AND REPORTS
213. The authority citation for 21 CFR part 1002 is revised to read
as follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371,
374.
PART 1003--NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
214. The authority citation for 21 CFR part 1003 is revised to read
as follows:
Authority: 42 U.S.C. 263b-263n.
PART 1004--REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC
PRODUCTS
215. The authority citation for 21 CFR part 1004 is revised to read
as follows:
Authority: 42 U.S.C. 263b-263n.
PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS
216. The authority citation for 21 CFR part 1005 is revised to read
as follows:
Authority: 42 U.S.C. 263d, 263h.
PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
217. The authority citation for 21 CFR part 1010 is revised to read
as follows:
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42
U.S.C. 263b-263n.
PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING
PRODUCTS
218. The authority citation for 21 CFR part 1020 is revised to read
as follows:
Authority: 21 U.S.C. 351, 352, 360e-360j, 360gg-360ss, 371, 381.
PART 1030--PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY
EMITTING PRODUCTS
219. The authority citation for 21 CFR part 1030 is revised to read
as follows:
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42
U.S.C. 263b-263n.
PART 1040 --PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
220. The authority citation for 21 CFR part 1040 is revised to read
as follows:
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42
U.S.C. 263b-263n.
PART 1050--PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND
ULTRASONIC RADIATION-EMITTING PRODUCTS
221. The authority citation for 21 CFR part 1050 is revised to read
as follows:
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42
U.S.C. 263b-263n.
PART 1210--REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT
222. The authority citation for 21 CFR part 1210 is revised to read
as follows:
Authority: 21 U.S.C. 141-149.
PART 1220--REGULATIONS UNDER THE TEA IMPORTATION ACT
223. The authority citation for 21 CFR part 1220 is revised to read
as follows:
Authority: 21 U.S.C. 41-50; 19 U.S.C. 1311.
PART 1230--REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT
224. The authority citation for 21 CFR part 1230 is revised to read
as follows:
Authority: 15 U.S.C. 1261-1276.
PART 1240--CONTROL OF COMMUNICABLE DISEASES
225. The authority citation for 21 CFR part 1240 is revised to read
as follows:
Authority: 42 U.S.C. 216, 243, 264, 271.
PART 1250--INTERSTATE CONVEYANCE SANITATION
226. The authority citation for 21 CFR part 1250 is revised to read
as follows:
Authority: 42 U.S.C. 216, 243, 264, 271.
PART 1270--HUMAN TISSUE INTENDED FOR TRANSPLANTATION
227. The authority citation for 21 CFR part 1270 is revised to read
as follows:
Authority: 42 U.S.C. 216, 243, 264, 271.
Dated: September 12, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-25668 Filed 9-25-97; 8:45 am]
BILLING CODE 4160-01-F
