81 FR 49894 - Change of Address; Technical Amendment
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 146 (July 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 146 (July 29, 2016)
| Page Range | 49894-49897 | |
| FR Document | 2016-17658 |
[Federal Register Volume 81, Number 146 (Friday, July 29, 2016)] [Rules and Regulations] [Pages 49894-49897] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17658] ======================================================================= ----------------------------------------------------------------------- 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
![49894 Federal Register / Vol. 81, No. 146 / Friday, July 29, 2016 / Rules and Regulations
construct constrains our ability to timely Final rule; technical
ACTION: 21 CFR Part 80
address a flawed standard, which could amendment.
actually delay implementation of the Color additives, Cosmetics, Drugs,
protections the Commission seeks to put in SUMMARY: The Food and Drug Reporting and recordkeeping
place. Administration (FDA or we) is requirements.
Given the realities of the standards amending our regulations to reflect a
development and approval process, we are 21 CFR Part 100
change in the address for the Center for
likely years away from a supply chain Administrative practice and
standard being implemented, even under the
Food Safety and Applied Nutrition
(CFSAN). This action is editorial in procedure, Food labeling, Food
aggressive schedule contemplated in the
order. I believe that the Commission should nature and is intended to improve the packaging, Foods, Intergovernmental
endeavor to provide as much advance accuracy of our regulations. relations.
guidance as possible before mandating the DATES: This rule is effective July 29, 21 CFR Part 101
development of a standard, to increase the 2016.
likelihood that NERC develops a standard Food labeling, Nutrition, Reporting
that will be satisfactory to the Commission FOR FURTHER INFORMATION CONTACT: John and recordkeeping requirements.
and reduce the need for a remand. I worry Reilly, Center for Food Safety and
that the limited process that preceded the Applied Nutrition (HFS–024), Food and 21 CFR Part 102
Final Rule and the expedited timetable will Drug Administration, 5001 Campus Dr., Beverages, Food grades and standards,
make it extremely difficult for NERC to file College Park, MD 20740. Food labeling, Frozen foods, Oils and
a standard that the Commission can cleanly
SUPPLEMENTARY INFORMATION: We are fats, Onions, Potatoes, Seafood.
approve. Had the Commission committed
itself to conducting adequate outreach, I amending our regulations in 21 CFR
21 CFR Part 106
believe we could have mitigated the parts 1, 5, 70, 71, 73, 80, 100, 101, 102,
likelihood of that outcome, and more 106, 107, 108, 109, 110, 112, 117, 118, Food grades and standards, Infants
effectively and promptly addressed the 130, 161, 170, 171, 172, 173, 175, 176, and children, Nutrition, Reporting and
supply chain threat in the long term. 177, 178, 180, 181, 184, 189, 190, 211, recordkeeping requirements.
‘‘Delaying’’ action for a few months thus 507, 701, 710, 720, and 1250 to reflect
would, in the long run, lead to prompter and 21 CFR Part 107
a change in the address for CFSAN. The
stronger protection for the grid. street address listed currently in our Food labeling, Infants and children,
II. Conclusion regulations for CFSAN is 5100 Paint Nutrition, Reporting and recordkeeping
The choice the Commission faces today on Branch Pkwy., College Park, MD 20740. requirements, Signs and symbols.
supply chain risk management is not The street has been renamed and the
21 CFR Part 108
between action and inaction. Rather, given street number has been changed; the
the importance of this issue, I believe that new street address is 5001 Campus Dr., Administrative practice and
more considered action and a more College Park, MD 20740. Consequently, procedure, Foods, Reporting and
developed Commission order, even if we are amending our regulations to recordkeeping requirements.
delayed by a few months, is better than a reflect the new street address.
quick decision to ‘‘do something.’’ 21 CFR Part 109
Publication of this document
Ultimately, an effective, auditable, and
enforceable standard on supply chain constitutes final action on these changes Food packaging, Foods,
management will require thoughtful under the Administrative Procedure Act Polychlorinated biphenyls (PCB’s).
consideration of the complex challenges of (5 U.S.C. 553). Notice and public
21 CFR Part 110
addressing cybersecurity threats posed procedure are unnecessary because we
through the supply chain within the are merely updating the street address Food packaging, Foods.
structure of the FERC/NERC reliability for CFSAN.
process. In my view, the Commission gains 21 CFR Part 112
very little and does not meaningfully List of Subjects Foods, Fruits and vegetables,
advance the security of the grid by Incorporation by reference, Packaging
21 CFR Part 1
proceeding straight to a Final Rule, rather
than taking the time to build a record to Cosmetics, Drugs, Exports, Food and containers, Recordkeeping
support a workable standard. labeling, Imports, Labeling, Reporting requirements, Safety.
Accordingly, I respectfully dissent. and recordkeeping requirements. 21 CFR Part 117
Cheryl A. LaFleur, 21 CFR Part 5 Food packaging, Foods.
Commissioner. Authority delegations (Government 21 CFR Part 118
[FR Doc. 2016–17842 Filed 7–28–16; 8:45 am] agencies), Imports, Organization and
functions (Government agencies). Eggs and egg products, Incorporation
BILLING CODE 6717–01–P
by reference, Recordkeeping
21 CFR Part 70 requirements, Safety.
DEPARTMENT OF HEALTH AND Color additives, Cosmetics, Drugs, 21 CFR Part 130
HUMAN SERVICES Labeling, Packaging and containers.
Food additives, Food grades and
21 CFR Part 71 standards.
Food and Drug Administration
Administrative practice and 21 CFR Part 161
asabaliauskas on DSK3SPTVN1PROD with RULES
[Docket No. FDA–2016–N–0011] procedure, Color additives, Confidential
business information, Cosmetics, Drugs, Food grades and standards, Frozen
21 CFR Chapter I foods, Seafood.
Reporting and recordkeeping
Change of Address; Technical requirements. 21 CFR Part 170
Amendment 21 CFR Part 73 Administrative practice and
AGENCY: Food and Drug Administration, Color additives, Cosmetics, Drugs, procedure, Food additives, Reporting
HHS. Medical devices. and recordkeeping requirements.
VerDate Sep<11>2014 17:04 Jul 28, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 E:\FR\FM\29JYR1.SGM 29JYR1](https://thefederalregister.org/doc/81_FR_50040/page/1.svg)
![Federal Register / Vol. 81, No. 146 / Friday, July 29, 2016 / Rules and Regulations 49897
PART 184—DIRECT FOOD PART 710—VOLUNTARY DATES: Effective: September 1, 2016.
SUBSTANCES AFFIRMED AS REGISTRATION OF COSMETIC FOR FURTHER INFORMATION CONTACT:
GENERALLY RECOGNIZED AS SAFE PRODUCT ESTABLISHMENTS Elizabeth Dawson, ONRR, telephone at
(303) 231–3653, or email to
■ 59. The authority citation for part 184 ■ 71. The authority citation for part 710
lisa.dawson@onrr.gov.
continues to read as follows: continues to read as follows:
SUPPLEMENTARY INFORMATION: With this
Authority: 21 U.S.C. 321, 342, 348, 371. Authority: 21 U.S.C. 321, 331, 361, 362,
final rule, ONRR amends the four
■ 60. In part 184, revise all references to 371, 374.
designated areas to define them as
‘‘5100 Paint Branch Pkwy.’’ to read ■ 72. In part 710, revise all references to follows:
‘‘5001 Campus Dr.’’. ‘‘5100 Paint Branch Pkwy.’’ to read 1. North Fort Berthold—all lands
‘‘5001 Campus Dr.’’. within the Fort Berthold Reservation
PART 189—SUBSTANCES
PART 720—VOLUNTARY FILING OF boundary north of the Missouri River,
PROHIBITED FROM USE IN HUMAN
COSMETIC PRODUCT INGREDIENT including the Turtle Mountain public
FOOD
COMPOSITION STATEMENTS domain lease lands north of the
■ 61. The authority citation for part 189 Missouri River that the Fort Berthold
continues to read as follows: ■ 73. The authority citation for part 720 Agency of the Bureau of Indian Affairs
continues to read as follows: (BIA) administers, with the dividing
Authority: 21 U.S.C. 321, 342, 348, 371,
381. Authority: 21 U.S.C. 321, 331, 361, 362, line of the Missouri River being the
■ 62. In part 189, revise all references to 371, 374. county lines that follow the Missouri
‘‘5100 Paint Branch Pkwy.’’ to read ■ 74. In part 720, revise all references to River.
‘‘5001 Campus Dr.’’. ‘‘5100 Paint Branch Pkwy.’’ to read 2. South Fort Berthold—all lands
‘‘5001 Campus Dr.’’. within the Fort Berthold Reservation
PART 190—DIETARY SUPPLEMENTS boundary south of the Missouri River,
PART 1250—INTERSTATE including the Turtle Mountain public
■ 63. The authority citation for part 190 CONVEYANCE SANITATION domain lease lands south of the
continues to read as follows: Missouri River that the Fort Berthold
■ 75. The authority citation for part
Authority: Secs. 201(ff), 301, 402, 413, 701 Agency of the BIA administers, with the
1250 continues to read as follows:
of the Federal Food, Drug, and Cosmetic Act dividing line of the Missouri River being
(21 U.S.C. 321(ff), 331, 342, 350b, 371). Authority: 42 U.S.C. 216, 243, 264, 271. the county lines that follow the
■ 64. In part 190, revise all references to ■ 76. In part 1250, revise all references Missouri River.
‘‘5100 Paint Branch Pkwy.’’ to read to ‘‘5100 Paint Branch Pkwy.’’ to read 3. Uintah & Ouray—Emery, Uintah,
‘‘5001 Campus Dr.’’. ‘‘5001 Campus Dr.’’. and Grand Counties.
Dated: July 21, 2016. 4. Uintah & Ouray—Duchesne,
PART 211—CURRENT GOOD Wasatch, and Carbon Counties.
Leslie Kux,
MANUFACTURING PRACTICE FOR Under the new Indian Oil Valuation
FINISHED PHARMACEUTICALS Associate Commissioner for Policy.
Amendments to 30 CFR 1206.54 (80 FR
[FR Doc. 2016–17658 Filed 7–28–16; 8:45 am]
■ 65. The authority citation for part 211 24794 dated May 1, 2015), ONRR uses
BILLING CODE 4164–01–P
continues to read as follows: designated areas to calculate index-
based major portion prices for lessees to
Authority: 21 U.S.C. 321, 351, 352, 355, comply with the major portion
360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. DEPARTMENT OF THE INTERIOR provisions in their leases. Designated
■ 66. In part 211, revise all references to areas are those areas ONRR identifies as
‘‘5100 Paint Branch Pkwy.’’ to read Office of Natural Resources Revenue
unique based on their location and the
‘‘5001 Campus Dr.’’. crude type produced from their
30 CFR Parts 1206 and 1210
respective Indian lands.
PART 507—CURRENT GOOD
[Docket No. ONRR–2014–0001; DS63642000 When ONRR proposed the new Indian
MANUFACTURING PRACTICE, DR2PS0000.CH7000167D0102R2] Oil Valuation Amendments, it proposed
HAZARD ANALYSIS, AND RISK–
sixteen initial designated areas.
BASED PREVENTIVE CONTROLS FOR Amendments to Designated Areas Generally, these designated areas were
FOOD FOR ANIMALS
AGENCY: Office of the Secretary, Office the Indian reservation boundaries.
■ 67. The authority citation for part 507 of Natural Resources Revenue (ONRR), However, there were five designated
continues to read as follows: Interior. areas which were not the reservation
Authority: 21 U.S.C. 331, 342, 343, 350d ACTION: Final rule. boundaries: Oklahoma; North Fort
note, 350g, 350g note, 371, 374; 42 U.S.C. Berthold; South Fort Berthold; Uintah &
243, 264, 271. SUMMARY: ONRR convened two Ouray: Uintah and Grand Counties; and
■ 68. In part 507, revise all references to technical conferences on November 20, Uintah and Ouray: Duchesne County.
‘‘5100 Paint Branch Pkwy.’’ to read 2015 to discuss amending the Under the new Indian Oil Valuation
‘‘5001 Campus Dr.’’. boundaries of four of the designated Amendments, to modify or change an
areas it uses to calculate the index-based existing designated area, ONRR must
PART 701—COSMETIC LABELING major portion prices in its regulations. convene a technical conference. In
asabaliauskas on DSK3SPTVN1PROD with RULES
At the technical conferences, the implementing the new Indian Oil
■ 69. The authority citation for part 701 participants discussed issues regarding Valuation Amendments, ONRR
continues to read as follows: the appropriate boundary line between discovered two potential issues. First,
Authority: 21 U.S.C. 321, 352, 361, 362, the North Fort Berthold and South Fort the preamble describes the dividing line
363, 371, 374; 15 U.S.C. 1454, 1455. Berthold Designated Areas and adding between the North Fort Berthold
■ 70. In part 701, revise all references to additional counties to one or both of the Designated Area and the South Fort
‘‘5100 Paint Branch Pkwy.’’ to read two designated areas in the Uintah and Berthold Designated Area as the Little
‘‘5001 Campus Dr.’’. Ouray Reservation. Missouri River. Second, ONRR found at
VerDate Sep<11>2014 17:04 Jul 28, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 E:\FR\FM\29JYR1.SGM 29JYR1](https://thefederalregister.org/doc/81_FR_50040/page/4.svg)
Document Created: 2018-02-08 07:51:41
Document Modified: 2018-02-08 07:51:41
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule; technical amendment. | |
| Dates | This rule is effective July 29, 2016. | |
| Contact | John Reilly, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. | |
| FR Citation | 81 FR 49894 |
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