[List of CFR Sections Affected (LSA), December 2017] [From the U.S. Government Publishing Office, www.gpo.gov] TITLE 21_FOOD AND DRUGS Chapter I_Food and Drug Administration, Department of Health and Human Services (Parts 1_1299) 1 Policy statement............................16733, 30730, 51345, 55503 4.82 (b) revised...................................................45393 10.60 (a), (d) and (f) revised.....................................45393 10.61 Revised......................................................45394 11 Compliance notification; interim................................20825 Technical correction; interim....................................34401 11.1 Regulation at 82 FR 20825 comment period extended to 8-2-17; interim....................................30730 12.5 Revised.......................................................45394 12.11 (b) revised..................................................45394 14.100 (f) removed.................................................58554 16.1 (b)(2) amended................................................61446 17.3 (a) revised...................................................34402 18 Revised.........................................................45394 19.15 (f) and (g)(1) revised.......................................45404 21.112 Notification................................................42031 [[Page 50]] 73.70 Added........................................................51557 73.530 (c) revised.................................................30734 Regulation at 82 FR 30734 confirmed..............................43845 101 Compliance notification; interim...............................20825 101 Technical correction; interim..................................34401 101.8 Regulation at 82 FR 20825 comment period extended to 8-2-17; interim....................................30730 101.9 Regulation at 82 FR 20825 comment period extended to 8-2-17; interim....................................30730 113.63 (c)(1) revised..............................................45404 117 Policy statement...............................................51345 121 Notification...................................................40484 122.92 (g) revised.................................................45405 122.118 (b) revised................................................45405 122.119 (b) revised................................................45405 122.120 (c) and (k) revised........................................45405 123.31 (b) revised.................................................45405 123.32 Revised.....................................................45405 123.34 Removed.....................................................45405 123.42 (c) heading, (1) and (d) introductory text revised........................................................45405 123.52 (a) revised.................................................45405 123.64 (a) revised.................................................45405 133 Policy Statement...............................................37815 141.61 (e)(1)(i)(A) revised........................................45405 142.18 (a)(1) and (2) revised......................................45406 142.28 (a)(2) revised..............................................45406 143.1 (c) revised..................................................45406 144.22 (b) revised.................................................45406 144.36 (c), (d) introductory text, (f) and (g)(4) revised........................................................45406 144.37 (a) and (b) revised.........................................45406 146.62 (a) and (b)(2) revised......................................45407 146.66 (a) and (b) amended.........................................45407 146.67 (b) and (c) revised.........................................45407 146.68 Revised.....................................................45407 151.9 Revised......................................................45407 177.1210 (b)(5) table 1 amended....................................20832 181.47 (b)(2)(ii)(E) Amended.......................................45407 201.128 Regulation at 82 FR 2217 comment period extended to 7-18-17............................................22741 310.545 (a)(27)(v), (vi), (vii), (viii), (ix), (x) and (d)(42) added; (d) introductory text amended........................................................60502 507 Policy statement...............................................51345 510.600 (c)(1) table and (2) table correctly amended........................................................21690 (c)(1) table and (2) table amended...............................43484 (c)(1) table and (2) table amended...............................58555 511.1 Heading and (c)(6) revised; (c)(1) and (2) amended; (c)(1)(i), (ii), (2)(i) and (ii) added..........................................................61446 520.48 (b) correctly amended.......................................21690 520.88g (c)(1)(ii) and (2)(ii) amended.............................43484 Heading, (a), and (b) revised....................................58556 520.304 (b)(1) and (2) revised; (b)(3) removed.....................43484 520.980 (b) correctly amended......................................21690 520.1445 (c)(1)(ii) revised........................................58556 520.1454 (b) correctly amended.....................................21690 522 Drug application approvals withdrawn...........................21694 522.90b (a) correctly amended......................................21690 522.304 (b) revised................................................43484 522.970 (b)(1) revised; (b)(3), (e)(2)(ii)(B) and (iii) removed; (e)(2)(ii) amended..............................43484 522.1002 (b) correctly removed; (c) correctly redesignated as new (b)........................................21690 522.1002 (b)(1) revised............................................43484 522.1055 (b) correctly amended.....................................21690 522.1335 (b) amended...............................................58556 522.1362 (b) correctly amended.....................................21690 522.1450 (b) correctly amended.....................................21690 522.1660a (e)(1)(ii) amended.......................................43484 522.1662a (e)(1) correctly revised; (e)(3)(i)(c) correctly amended..............................................21690 522.2470 (b), (c)(1)(i), (ii), and (2) revised.....................58556 522.2473 (b) correctly amended.....................................21691 522.2477 (b)(2) correctly revised; (d)(4) correctly added................................................21691 (b)(2) revised; (d)(1)(iii) through (4)(iii) amended; (d)(5) added..........................................43484 524.998 (c)(2) added...............................................43485 524.1450 (b)(1) correctly amended..................................21691 524.1580a (d)(3) amended...........................................58556 529.1030 (d)(1)(ii), (2)(iii), and (3) revised; (d)(2)(i) table and (ii) table amended.........................58556 558.4 (d) table correctly amended..................................21691 (d) table revised................................................43485 558.58 (f)(4) and (5) removed......................................58557 558.76 (e)(1)(vii) correctly removed...............................21691 558.115 (d)(4) correctly revised...................................21691 [[Page 51]] 558.128 (b)(1), (e)(1)(i), (v), (3)(v), (4)(iii) correctly amended; (e)(4)(xxiv) and (xxv) correctly redesignated as (e)(4)(xxv) and (xxvi); new (e)(4)(xxiv) correctly added.......................21691 (e)(4)(iii), (xi), (xii), (xiii), (5)(ii), (iii) and (6)(v) amended.............................................43485 558.140 (b)(1) correctly amended...................................21691 558.325 (e)(2)(vii) and (viii) correctly redesignated as (xvi) and (xvii); new (e)(2)(vii) correctly added....................................21691 558.366 (e) correctly revised......................................21692 (e) removed......................................................58557 558.485 (e)(1)(iv) correctly removed...............................21692 558.550 (d)(5) correctly added.....................................21692 558.625 (d)(2) correctly revised; (d)(4) and (5) correctly added; (e)(2)(iv), (v), (vi), (vii), (viii), (ix), (x), (xi), (xii), (xiii), (xiv) and (xv) corectly amended......................................21692 (e)(1)(vii), (ix), (2)(ii), (iii), (vi) through (xv) amended...................................................43485 558.635 (e)(1) correctly revised...................................21692 558.680 (e) correctly removed; (d)(3) correctly added..........................................................21693 573.170 (c) and (d) redesignated as (d) and (e); new (c) and new (d)(3) added; new (e) introductory text revised......................................52209 573.480 (b)(3) and (4) redesignated as (b)(4) and (5); new (b)(3) and (b)(4)(iii) added; new (b)(5) introductory text revised...............................52209 573.492 Added......................................................38596 801.4 Regulation at 82 FR 2217 comment period extended to 7-18-17............................................22741 814.3 (n) amended..................................................26349 814.100 (b) introductoty text amended..............................26349 814.102 (a)(5), (b)(3)(i) and (ii) amended.........................26349 814.124 (a) revised................................................26349 814.126 (b)(1)(iii) amended........................................26349 860.123 (b)(1) revised.............................................39535 862.1220 Added.....................................................50072 862.1840 Added.....................................................51559 862.3652 Added.....................................................48415 862.3800 Added.....................................................61163 864.7010 Added.....................................................61165 866 Authority citation revised.....................................34850 866.2190 Added.....................................................47969 866.2680 Added.....................................................50074 866.3215 Added.....................................................49099 866.3361 Added.....................................................49101 866.3920 Added.....................................................34850 866.3970 Added.....................................................48763 866.4750 Added.....................................................52648 876.5550 Added.....................................................52651 866.5665 Added.....................................................50076 866.5670 Added.....................................................49103 866.5930 Added.....................................................50079 866.5940 (b) introductory text revised.............................51570 866.5950 Added.....................................................51561 866.5985 Added.....................................................47971 866.6060 Added.....................................................50532 868 Authority citation revised.....................................60867 868.5105 Added.....................................................60867 870 Technical correction...........................................46900 870.1255 Added.....................................................34852 870.2200 Added.....................................................35067 876 Technical correction...........................................50080 876.4340 Added.....................................................45727 876.5981 Added.....................................................35069 880 Authority citation revised.....................................60307 880.2750 Added.....................................................60307 882 Technical correction...........................................47373 882.1580 Added.....................................................50082 882.1630 Added.....................................................35071 882.5801 Added.....................................................61167 882.5892 Added.....................................................61169 884 Authority citation revised.....................................35073 884.1710 Added.....................................................35073 884.4350 Added.....................................................60114 884.5210 Added.....................................................61448 886 Authority citation revised.....................................60115 886.5300 Added.....................................................60116 892.5720 Added.....................................................61171 1100.5 Regulation at 82 FR 2217 comment period extended to 7-18-17............................................22741 1271 Policy statement.......................................54289, 54290 Chapter II_Drug Enforcement Administration, Department of Justice (Parts 1300_1399) 1308.11 (h)(10) through (15) added (temporary).....................17123 (h)(16) added (temporary)........................................20547 (h)(4) removed; (b)(3) through (56) and (h)(5) through (15) redesignated to (b)(4) through (57) and (h)(4) [[Page 52]] through (14); new (b)(3) and new (15) added....................26351 (h)(17) added (temporary)........................................32457 (d)(69), (70) and (71) added; (h)(1), (2) and (3) removed; (h)(4) through (17) redesignated as (h)(1) through (14).........................................47974 (h)(15) through (21) added (temporary)...........................49508 (h)(18) added (temporary)........................................51158 (b)(40) through (57) redesignated as (b)(41) through (58); new (b)(40) added................................58559 1308.12 (b)(1) introductory text revised...........................45438 Regulation at 82 FR 14820 confirmed..............................55506 1310.02 (a)(1) through (30) redesignated as (a)(2) through (31); new (a)(1) added.................................32460 1310.04 (g)(1)(i) through (x) redesignated as (g)(1)(ii) through (xi); new (g)(1)(i) added 32460 1310.09 (n) added..................................................32460 1310.12 (c) table amended..........................................32460 Proposed Rules: 1--1299 (Ch. I).........40278, 40312, 42492, 42494, 42497, 42499, 42501, 42503, 42506, 43720, 49300, 57560 5f.................................................................43720 11..........................................................28277, 52036 15..........................................................56759, 58572 46.................................................................43720 73..........................................................16321, 52037 74.................................................................24912 101..................................................45753, 50324, 52036 112.........................................................42963, 47656 117................................................................41364 170.........................................................20847, 53433 172................................................................34615 172................................................................39711 177................................................................20847 189................................................................20847 312................................................................28277 570................................................................53433 573.......18268, 24611, 34615, 43197, 44128, 44129, 44368, 44542, 50598, 60920, 60921 803................................................................60922 812................................................................28277 878................................................................56763 880................................................................51585 884................................................................57174 1300--1399 (Ch. II)................................................29248 1308.....................25564, 32153, 42624, 42754, 55333, 58575, 61700