51512 Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Rules and Regulations

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.
Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Rules and Regulations 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.
51514 Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Rules and Regulations

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.
Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Rules and Regulations 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.
51516 Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Rules and Regulations

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.
Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Rules and Regulations 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.
51518 Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Rules and Regulations

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.
Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Rules and Regulations 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.
51520 Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Rules and Regulations

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.
Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Rules and Regulations 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