2016-17658. Change of Address; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA or we) is amending our regulations to reflect a change in the address for the Center for Food Safety and Applied Nutrition (CFSAN). This action is editorial in nature and is intended to improve the accuracy of our regulations.

DATES:

This rule is effective July 29, 2016.

FOR FURTHER INFORMATION CONTACT:

John Reilly, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.

SUPPLEMENTARY INFORMATION:

We are amending our regulations in 21 CFR parts 1, 5, 70, 71, 73, 80, 100, 101, 102, 106, 107, 108, 109, 110, 112, 117, 118, 130, 161, 170, 171, 172, 173, 175, 176, 177, 178, 180, 181, 184, 189, 190, 211, 507, 701, 710, 720, and 1250 to reflect a change in the address for CFSAN. The street address listed currently in our regulations for CFSAN is 5100 Paint Branch Pkwy., College Park, MD 20740. The street has been renamed and the street number has been changed; the new street address is 5001 Campus Dr., College Park, MD 20740. Consequently, we are amending our regulations to reflect the new street address.

Publication of this document constitutes final action on these changes under the Administrative Procedure Act (5 U.S.C. 553). Notice and public procedure are unnecessary because we are merely updating the street address for CFSAN.

List of Subjects

21 CFR Part 1

• Cosmetics
• Drugs
• Exports
• Food labeling
• Imports
• Labeling
• Reporting and recordkeeping requirements

21 CFR Part 5

• Authority delegations (Government agencies)
• Imports
• Organization and functions (Government agencies)

21 CFR Part 70

• Color additives
• Cosmetics
• Drugs
• Labeling
• Packaging and containers

21 CFR Part 71

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

21 CFR Part 73

• Color additives
• Cosmetics
• Drugs
• Medical devices

21 CFR Part 80

• Color additives
• Cosmetics
• Drugs
• Reporting and recordkeeping requirements

21 CFR Part 100

• Administrative practice and procedure
• Food labeling
• Food packaging
• Foods
• Intergovernmental relations

21 CFR Part 101

• Food labeling
• Nutrition
• Reporting and recordkeeping requirements

21 CFR Part 102

• Beverages
• Food grades and standards
• Food labeling
• Frozen foods
• Oils and fats
• Onions
• Potatoes
• Seafood

21 CFR Part 106

• Food grades and standards
• Infants and children
• Nutrition
• Reporting and recordkeeping requirements

21 CFR Part 107

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

21 CFR Part 108

• Administrative practice and procedure
• Foods
• Reporting and recordkeeping requirements

21 CFR Part 109

• Food packaging
• Foods
• Polychlorinated biphenyls (PCB's)

21 CFR Part 110

• Food packaging
• Foods

21 CFR Part 112

• Foods
• Fruits and vegetables
• Incorporation by reference
• Packaging and containers
• Recordkeeping requirements
• Safety

21 CFR Part 117

• Food packaging
• Foods

21 CFR Part 118

• Eggs and egg products
• Incorporation by reference
• Recordkeeping requirements
• Safety

21 CFR Part 130

• Food additives
• Food grades and standards

21 CFR Part 161

• Food grades and standards
• Frozen foods
• Seafood

21 CFR Part 170

• Administrative practice and procedure
• Food additives
• Reporting and recordkeeping requirements

21 CFR Part 171

• Administrative practice and procedure
• Food additives

21 CFR Part 172

• Food additives
• Reporting and recordkeeping requirements

21 CFR Part 173

• Food additives

21 CFR Part 175

• Adhesives
• Food additives
• Food packaging

21 CFR Part 176

• Food additives
• Food packaging

21 CFR Part 177

• Food additives
• Food packaging

21 CFR Part 178

• Food additives
• Food packaging

21 CFR Part 180

• Food additives

21 CFR Part 181

• Food additives
• Food packaging

21 CFR Part 184

• Food additives

21 CFR Part 189

• Food additives
• Food packaging

21 CFR Part 190

• Dietary foods
• Foods
• Food additives
• Reporting and recordkeeping requirements

21 CFR Part 211

• Drugs
• Labeling
• Laboratories
• Packaging and containers
• Prescription drugs
• Reporting and recordkeeping requirements
• Warehouses

21 CFR Part 507

• Animal foods
• Labeling
• Packaging and containers
• Reporting and recordkeeping requirements

21 CFR Part 701

• Cosmetics
• Labeling
• Reporting and recordkeeping requirements

21 CFR Part 710

• Cosmetics

21 CFR Part 720

• Confidential business information
• Cosmetics

21 CFR Part 1250

• Air carriers
• Foods
• Maritime carriers
• Motor carriers
• Public health
• Railroads
• Water supply

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 1, 5, 70, 71, 73, 80, 100, 101, 102, 106, 107, 108, 109, 110, 112, 117, 118, 130, 161, 170, 171, 172, 173, 175, 176, 177, 178, 180, 181, 184, 189, 190, 211, 507, 701, 710, 720, and 1250 are amended as follows:

PART 1—GENERAL ENFORCEMENT REGULATIONS

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

Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342i, 343, 350c, 350d, 350e, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 373, 374, 381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.

2. In part 1, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 5—ORGANIZATION

3. The authority citation for part 5 continues to read as follows:

Authority: 5 U.S.C. 552; 21 U.S.C. 301-397.

4. In part 5, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 70—COLOR ADDITIVES

5. The authority citation for part 70 continues to read as follows:

Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 360b, 361, 371, 379e.

6. In part 70, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 71—COLOR ADDITIVE PETITIONS

7. The authority citation for part 71 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 351, 355, 360, 360b-360f, 360h-360j, 361, 371, 379e, 381; 42 U.S.C. 216, 262.

8. In part 71, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

9. The authority citation for part 73 continues to read as follows:

Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.

10. In part 73, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 80—COLOR ADDITIVE CERTIFICATION

11. The authority citation for part 80 continues to read as follows:

Authority: 21 U.S.C. 371, 379e.

12. In part 80, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 100—GENERAL

13. The authority citation for part 100 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 337, 342, 343, 348, 371.

14. In part 100, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 101—FOOD LABELING

15. The authority citation for part 101 continues to read as follows:

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

16. In part 101, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 102—COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS

17. The authority citation for part 102 continues to read as follows:

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

18. In part 102, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS

19. The authority citation for part 106 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 350a, 371.

20. In part 106, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 107—INFANT FORMULA

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

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

22. In part 107, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 108—EMERGENCY PERMIT CONTROL

23. The authority citation for part 108 continues to read as follows:

Authority: 21 U.S.C. 342, 344, 371.

24. In part 108, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 109—UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL

25. The authority citation for part 109 continues to read as follows:

Authority: 21 U.S.C. 321, 336, 342, 346, 346a, 348, 371.

26. In part 109, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 110—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

27. The authority citation for part 110 continues to read as follows:

Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.

28. In part 110, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 112—STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

29. The authority citation for part 112 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271.

30. In part 112, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 117—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

31. The authority citation for part 117 continues to read as follows:

Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.

32. In part 117, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 118—PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS

33. The authority citation for part 118 continues to read as follows:

Authority: 21 U.S.C. 321, 331-334, 342, 371, 381, 393; 42 U.S.C. 243, 264, 271.

34. In part 118, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 130—FOOD STANDARDS: GENERAL

35. The authority citation for part 130 continues to read as follows:

Authority: 21 U.S.C. 321, 336, 341, 343, 371.

36. In part 130, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 161—FISH AND SHELLFISH

37. The authority citation for part 161 continues to read as follows:

Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

38. In part 161, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 170—FOOD ADDITIVES

39. The authority citation for part 170 continues to read as follows:

Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.

40. In part 170, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 171—FOOD ADDITIVE PETITIONS

41. The authority citation for part 171 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 371.

42. In part 171, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

43. The authority citation for part 172 continues to read as follows:

Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

44. In part 172, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION

45. The authority citation for part 173 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348.

46. In part 173, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 175—INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS

47. The authority citation for part 175 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

48. In part 175, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 176—INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

49. The authority citation for part 176 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 346, 348, 379e.

50. In part 176, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 177—INDIRECT FOOD ADDITIVES: POLYMERS

51. The authority citation for part 177 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

52. In part 177, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

53. The authority citation for part 178 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

54. In part 178, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 180—FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY

55. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 343, 348, 371; 42 U.S.C. 241.

56. In part 180, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 181—PRIOR-SANCTIONED FOOD INGREDIENTS

57. The authority citation for part 181 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 371.

58. In part 181, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

59. The authority citation for part 184 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 371.

60. In part 184, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 189—SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD

61. The authority citation for part 189 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 371, 381.

62. In part 189, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 190—DIETARY SUPPLEMENTS

63. The authority citation for part 190 continues to read as follows:

Authority: Secs. 201(ff), 301, 402, 413, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff), 331, 342, 350b, 371).

64. In part 190, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

65. The authority citation for part 211 continues to read as follows:

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

66. In part 211, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 507—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS

67. The authority citation for part 507 continues to read as follows:

Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.

68. In part 507, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 701—COSMETIC LABELING

69. The authority citation for part 701 continues to read as follows:

Authority: 21 U.S.C. 321, 352, 361, 362, 363, 371, 374; 15 U.S.C. 1454, 1455.

70. In part 701, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 710—VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS

71. The authority citation for part 710 continues to read as follows:

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

72. In part 710, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 720—VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS

73. The authority citation for part 720 continues to read as follows:

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

74. In part 720, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

PART 1250—INTERSTATE CONVEYANCE SANITATION

75. The authority citation for part 1250 continues to read as follows:

Authority: 42 U.S.C. 216, 243, 264, 271.

76. In part 1250, revise all references to “5100 Paint Branch Pkwy.” to read “5001 Campus Dr.”.

Dated: July 21, 2016.

Leslie Kux,

Associate Commissioner for Policy.