Change of Address; Technical Amendment, 49894-49897 [2016-17658]

Download as PDF 49894 Federal Register / Vol. 81, No. 146 / Friday, July 29, 2016 / Rules and Regulations construct constrains our ability to timely address a flawed standard, which could actually delay implementation of the protections the Commission seeks to put in place. Given the realities of the standards development and approval process, we are likely years away from a supply chain standard being implemented, even under the aggressive schedule contemplated in the order. I believe that the Commission should endeavor to provide as much advance guidance as possible before mandating the development of a standard, to increase the likelihood that NERC develops a standard that will be satisfactory to the Commission and reduce the need for a remand. I worry that the limited process that preceded the Final Rule and the expedited timetable will make it extremely difficult for NERC to file a standard that the Commission can cleanly approve. Had the Commission committed itself to conducting adequate outreach, I believe we could have mitigated the likelihood of that outcome, and more effectively and promptly addressed the supply chain threat in the long term. ‘‘Delaying’’ action for a few months thus would, in the long run, lead to prompter and stronger protection for the grid. II. Conclusion The choice the Commission faces today on supply chain risk management is not between action and inaction. Rather, given the importance of this issue, I believe that more considered action and a more developed Commission order, even if delayed by a few months, is better than a quick decision to ‘‘do something.’’ Ultimately, an effective, auditable, and enforceable standard on supply chain management will require thoughtful consideration of the complex challenges of addressing cybersecurity threats posed through the supply chain within the structure of the FERC/NERC reliability process. In my view, the Commission gains very little and does not meaningfully advance the security of the grid by proceeding straight to a Final Rule, rather than taking the time to build a record to support a workable standard. Accordingly, I respectfully dissent. 21 CFR Part 80 Final rule; technical amendment. ACTION: 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. SUMMARY: 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 Cheryl A. LaFleur, Commissioner. BILLING CODE 6717–01–P 21 CFR Part 70 Color additives, Cosmetics, Drugs, Labeling, Packaging and containers. DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR Part 71 asabaliauskas on DSK3SPTVN1PROD with RULES Food and Drug Administration Change of Address; Technical Amendment Food and Drug Administration, VerDate Sep<11>2014 17:04 Jul 28, 2016 Jkt 238001 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 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 21 CFR Part 73 21 CFR Chapter I HHS. Administrative practice and procedure, Food labeling, Food packaging, Foods, Intergovernmental relations. Administrative practice and procedure, Color additives, Confidential business information, Cosmetics, Drugs, Reporting and recordkeeping requirements. [Docket No. FDA–2016–N–0011] AGENCY: 21 CFR Part 100 Food packaging, Foods. Authority delegations (Government agencies), Imports, Organization and functions (Government agencies). [FR Doc. 2016–17842 Filed 7–28–16; 8:45 am] Color additives, Cosmetics, Drugs, Reporting and recordkeeping requirements. Administrative practice and procedure, Food additives, Reporting and recordkeeping requirements. Color additives, Cosmetics, Drugs, Medical devices. PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 Food grades and standards, Frozen foods, Seafood. 21 CFR Part 170 E:\FR\FM\29JYR1.SGM 29JYR1 Federal Register / Vol. 81, No. 146 / Friday, July 29, 2016 / Rules and Regulations 21 CFR Part 171 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: Administrative practice and procedure, Food additives. 21 CFR Part 172 Food additives, Reporting and recordkeeping requirements. 49895 PART 80—COLOR ADDITIVE CERTIFICATION 11. The authority citation for part 80 continues to read as follows: ■ Authority: 21 U.S.C. 371, 379e. PART 1—GENERAL ENFORCEMENT REGULATIONS 12. In part 80, revise all references to ‘‘5100 Paint Branch Pkwy.’’ to read ‘‘5001 Campus Dr.’’. ■ 1. The authority citation for part 1 continues to read as follows: PART 100—GENERAL 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. ■ ■ 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. 2. In part 1, revise all references to ‘‘5100 Paint Branch Pkwy.’’ to read ‘‘5001 Campus Dr.’’. ■ 21 CFR Part 178 Food additives, Food packaging. 21 CFR Part 180 3. The authority citation for part 5 continues to read as follows: Food additives, Food packaging. Authority: 5 U.S.C. 552; 21 U.S.C. 301– 397. 21 CFR Part 184 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: ■ 21 CFR Part 181 Authority: 21 U.S.C. 321, 331, 337, 342, 343, 348, 371. ■ PART 5—ORGANIZATION Food additives. 13. The authority citation for part 100 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 70—COLOR ADDITIVES Food additives. PART 102—COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS 4. In part 5, revise all references to ‘‘5100 Paint Branch Pkwy.’’ to read ‘‘5001 Campus Dr.’’. 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. 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. 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.’’. ■ 6. In part 70, revise all references to ‘‘5100 Paint Branch Pkwy.’’ to read ‘‘5001 Campus Dr.’’. ■ 21 CFR Part 507 PART 71—COLOR ADDITIVE PETITIONS Animal foods, Labeling, Packaging and containers, Reporting and recordkeeping requirements. ■ PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS 7. The authority citation for part 71 continues to read as follows: 21 CFR Part 701 Cosmetics, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 710 Cosmetics. asabaliauskas on DSK3SPTVN1PROD with RULES 8. In part 71, revise all references to ‘‘5100 Paint Branch Pkwy.’’ to read ‘‘5001 Campus Dr.’’. ■ 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 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION 21 CFR Part 720 Confidential business information, Cosmetics. PART 107—INFANT FORMULA 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 17:04 Jul 28, 2016 9. The authority citation for part 73 continues to read as follows: ■ 21 CFR Part 1250 VerDate Sep<11>2014 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. Jkt 238001 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.’’. ■ PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 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.’’. ■ E:\FR\FM\29JYR1.SGM 29JYR1 49896 Federal Register / Vol. 81, No. 146 / Friday, July 29, 2016 / Rules and Regulations Authority: 21 U.S.C. 321, 331–334, 342, 371, 381, 393; 42 U.S.C. 243, 264, 271. 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: ■ 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 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, 336, 342, 346, 346a, 348, 371. ■ 26. In part 109, revise all references to ‘‘5100 Paint Branch Pkwy.’’ to read ‘‘5001 Campus Dr.’’. 37. The authority citation for part 161 continues to read as follows: Authority: 21 U.S.C. 321, 342, 346, 348, 379e. 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 110—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD PART 170—FOOD ADDITIVES 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.’’. ■ 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: ■ 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. Authority: 21 U.S.C. 321, 342, 348, 371. 54. In part 178, revise all references to ‘‘5100 Paint Branch Pkwy.’’ to read ‘‘5001 Campus Dr.’’. ■ 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 PART 180—FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY PART 117—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK– BASED PREVENTIVE CONTROLS FOR HUMAN FOOD ■ 43. The authority citation for part 172 continues to read as follows: ■ 31. The authority citation for part 117 continues to read as follows: Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e. Authority: 21 U.S.C. 321, 342, 343, 348, 371; 42 U.S.C. 241. ■ ■ 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.’’. asabaliauskas on DSK3SPTVN1PROD with RULES ■ 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: ■ PART 118—PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS 33. The authority citation for part 118 continues to read as follows: ■ VerDate Sep<11>2014 17:04 Jul 28, 2016 Jkt 238001 55. The authority citation for part 180 continues to read as follows: 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. 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.’’. ■ PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 58. In part 181, revise all references to ‘‘5100 Paint Branch Pkwy.’’ to read ‘‘5001 Campus Dr.’’. ■ E:\FR\FM\29JYR1.SGM 29JYR1 Federal Register / Vol. 81, No. 146 / Friday, July 29, 2016 / Rules and Regulations PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE PART 710—VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS 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.’’. 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.’’. ■ ■ PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Dated: July 21, 2016. Leslie Kux, Associate Commissioner for Policy. 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.’’. [FR Doc. 2016–17658 Filed 7–28–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF THE INTERIOR ■ 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.’’. asabaliauskas on DSK3SPTVN1PROD with RULES ■ 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.’’. ■ VerDate Sep<11>2014 17:04 Jul 28, 2016 Jkt 238001 Office of Natural Resources Revenue 30 CFR Parts 1206 and 1210 [Docket No. ONRR–2014–0001; DS63642000 DR2PS0000.CH7000167D0102R2] Amendments to Designated Areas Office of the Secretary, Office of Natural Resources Revenue (ONRR), Interior. ACTION: Final rule. AGENCY: ONRR convened two technical conferences on November 20, 2015 to discuss amending the boundaries of four of the designated areas it uses to calculate the index-based major portion prices in its regulations. At the technical conferences, the participants discussed issues regarding the appropriate boundary line between the North Fort Berthold and South Fort Berthold Designated Areas and adding additional counties to one or both of the two designated areas in the Uintah and Ouray Reservation. SUMMARY: PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 DATES: 49897 Effective: September 1, 2016. FOR FURTHER INFORMATION CONTACT: Elizabeth Dawson, ONRR, telephone at (303) 231–3653, or email to lisa.dawson@onrr.gov. SUPPLEMENTARY INFORMATION: With this final rule, ONRR amends the four designated areas to define them as follows: 1. North Fort Berthold—all lands within the Fort Berthold Reservation boundary north of the Missouri River, including the Turtle Mountain public domain lease lands north of the Missouri River that the Fort Berthold Agency of the Bureau of Indian Affairs (BIA) administers, with the dividing line of the Missouri River being the county lines that follow the Missouri River. 2. South Fort Berthold—all lands within the Fort Berthold Reservation boundary south of the Missouri River, including the Turtle Mountain public domain lease lands south of the Missouri River that the Fort Berthold Agency of the BIA administers, with the dividing line of the Missouri River being the county lines that follow the Missouri River. 3. Uintah & Ouray—Emery, Uintah, and Grand Counties. 4. Uintah & Ouray—Duchesne, Wasatch, and Carbon Counties. Under the new Indian Oil Valuation Amendments to 30 CFR 1206.54 (80 FR 24794 dated May 1, 2015), ONRR uses designated areas to calculate indexbased major portion prices for lessees to comply with the major portion provisions in their leases. Designated areas are those areas ONRR identifies as unique based on their location and the crude type produced from their respective Indian lands. When ONRR proposed the new Indian Oil Valuation Amendments, it proposed sixteen initial designated areas. Generally, these designated areas were the Indian reservation boundaries. However, there were five designated areas which were not the reservation boundaries: Oklahoma; North Fort Berthold; South Fort Berthold; Uintah & Ouray: Uintah and Grand Counties; and Uintah and Ouray: Duchesne County. Under the new Indian Oil Valuation Amendments, to modify or change an existing designated area, ONRR must convene a technical conference. In implementing the new Indian Oil Valuation Amendments, ONRR discovered two potential issues. First, the preamble describes the dividing line between the North Fort Berthold Designated Area and the South Fort Berthold Designated Area as the Little Missouri River. Second, ONRR found at E:\FR\FM\29JYR1.SGM 29JYR1

Agencies

[Federal Register Volume 81, Number 146 (Friday, July 29, 2016)]
[Rules and Regulations]
[Pages 49894-49897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17658]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0011]

21 CFR Chapter I


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.

[[Page 49895]]

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

0
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.


0
2. In part 1, revise all references to ``5100 Paint Branch Pkwy.'' to 
read ``5001 Campus Dr.''.

PART 5--ORGANIZATION

0
3. The authority citation for part 5 continues to read as follows:

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


0
4. In part 5, revise all references to ``5100 Paint Branch Pkwy.'' to 
read ``5001 Campus Dr.''.

PART 70--COLOR ADDITIVES

0
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.


0
6. In part 70, revise all references to ``5100 Paint Branch Pkwy.'' to 
read ``5001 Campus Dr.''.

PART 71--COLOR ADDITIVE PETITIONS

0
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.


0
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

0
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.


0
10. In part 73, revise all references to ``5100 Paint Branch Pkwy.'' to 
read ``5001 Campus Dr.''.

PART 80--COLOR ADDITIVE CERTIFICATION

0
11. The authority citation for part 80 continues to read as follows:

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


0
12. In part 80, revise all references to ``5100 Paint Branch Pkwy.'' to 
read ``5001 Campus Dr.''.

PART 100--GENERAL

0
13. The authority citation for part 100 continues to read as follows:

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


0
14. In part 100, revise all references to ``5100 Paint Branch Pkwy.'' 
to read ``5001 Campus Dr.''.

PART 101--FOOD LABELING

0
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.


0
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

0
17. The authority citation for part 102 continues to read as follows:

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


0
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

0
19. The authority citation for part 106 continues to read as follows:

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


0
20. In part 106, revise all references to ``5100 Paint Branch Pkwy.'' 
to read ``5001 Campus Dr.''.

PART 107--INFANT FORMULA

0
21. The authority citation for part 107 continues to read as follows:

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


0
22. In part 107, revise all references to ``5100 Paint Branch Pkwy.'' 
to read ``5001 Campus Dr.''.

[[Page 49896]]

PART 108--EMERGENCY PERMIT CONTROL

0
23. The authority citation for part 108 continues to read as follows:

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


0
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

0
25. The authority citation for part 109 continues to read as follows:

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


0
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

0
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.


0
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

0
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.


0
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

0
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.


0
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

0
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.


0
34. In part 118, revise all references to ``5100 Paint Branch Pkwy.'' 
to read ``5001 Campus Dr.''.

PART 130--FOOD STANDARDS: GENERAL

0
35. The authority citation for part 130 continues to read as follows:

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


0
36. In part 130, revise all references to ``5100 Paint Branch Pkwy.'' 
to read ``5001 Campus Dr.''.

PART 161--FISH AND SHELLFISH

0
37. The authority citation for part 161 continues to read as follows:

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


0
38. In part 161, revise all references to ``5100 Paint Branch Pkwy.'' 
to read ``5001 Campus Dr.''.

PART 170--FOOD ADDITIVES

0
39. The authority citation for part 170 continues to read as follows:

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


0
40. In part 170, revise all references to ``5100 Paint Branch Pkwy.'' 
to read ``5001 Campus Dr.''.

PART 171--FOOD ADDITIVE PETITIONS

0
41. The authority citation for part 171 continues to read as follows:

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


0
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

0
43. The authority citation for part 172 continues to read as follows:

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

0
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

0
45. The authority citation for part 173 continues to read as follows:

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


0
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

0
47. The authority citation for part 175 continues to read as follows:

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


0
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

0
49. The authority citation for part 176 continues to read as follows:

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


0
50. In part 176, revise all references to ``5100 Paint Branch Pkwy.'' 
to read ``5001 Campus Dr.''.

PART 177--INDIRECT FOOD ADDITIVES: POLYMERS

0
51. The authority citation for part 177 continues to read as follows:

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


0
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

0
53. The authority citation for part 178 continues to read as follows:

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


0
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

0
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.


0
56. In part 180, revise all references to ``5100 Paint Branch Pkwy.'' 
to read ``5001 Campus Dr.''.

PART 181--PRIOR-SANCTIONED FOOD INGREDIENTS

0
57. The authority citation for part 181 continues to read as follows:

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


0
58. In part 181, revise all references to ``5100 Paint Branch Pkwy.'' 
to read ``5001 Campus Dr.''.

[[Page 49897]]

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

0
59. The authority citation for part 184 continues to read as follows:

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


0
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

0
61. The authority citation for part 189 continues to read as follows:

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


0
62. In part 189, revise all references to ``5100 Paint Branch Pkwy.'' 
to read ``5001 Campus Dr.''.

PART 190--DIETARY SUPPLEMENTS

0
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).


0
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

0
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.


0
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

0
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.


0
68. In part 507, revise all references to ``5100 Paint Branch Pkwy.'' 
to read ``5001 Campus Dr.''.

PART 701--COSMETIC LABELING

0
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.


0
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

0
71. The authority citation for part 710 continues to read as follows:

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


0
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

0
73. The authority citation for part 720 continues to read as follows:

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


0
74. In part 720, revise all references to ``5100 Paint Branch Pkwy.'' 
to read ``5001 Campus Dr.''.

PART 1250--INTERSTATE CONVEYANCE SANITATION

0
75. The authority citation for part 1250 continues to read as follows:

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


0
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.
[FR Doc. 2016-17658 Filed 7-28-16; 8:45 am]
 BILLING CODE 4164-01-P

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