[List of CFR Sections Affected (LSA), 1986-2000, Volume II (Titles 17 through 27)] [From the U.S. Government Printing Office, www.gpo.gov] Title 21 1986 21 CFR 51 FR Page Chapter I Chapter I Mandatory compliance date 1-1-89.........................34085 2.125 (Subpart G) Authority citation revised........................4591 (e)(9) and (10) added...........................................4591 5 Authority citation revised; section authority citations removed 19328 5.10 (a)(28) added.................................................19328 5.22 (a)(12)(v) removed; (a)(12)(vi) and (vii) redesignated as (a)(12)(v) and (vi); (a)(2), (6), and (12)(iii) revised....11428 (a)(12)(iii) revised...........................................32452 (a)(4)(iii), (7)(iii), (iv), and (vi), and (8)(v) revised......41765 5.23 (a)(8) removed; (a)(9) and (10) redesignated as (a)(8) and (9); (a)(2) revised........................................11428 5.28 Added.........................................................25883 5.30 (a)(7) and (c)(8) revised..............................11428, 32452 5.31 (f)(4) and (5) added..........................................17011 5.36 Revised................................................11428, 32452 5.37 (a)(5)(iv) and (b)(4) introductory text revised........11428, 32452 5.45 (a) introductory text, (b) introductory text, (c)(5), (d), and (e)(4) revised..................................11428, 32452 5.47 (d) revised............................................11428, 32452 5.63 Introductory text revised..............................11428, 32452 5.89 (a) introductory text revised..........................11428, 32452 5.100 Revised......................................................11429 5.115 Amended......................................................11430 14 Authority citation revised; section authority citations removed 32631 14.100 (d)(3) removed..............................................32631 16 Authority citation revised......................................26364 16.1 (b)(2) amended................................................26364 (b)(2) Technical correction....................................34589 20.100 (c)(8) revised..............................................22475 73.75 (c) revision effective date confirmed.........................5989 73.3111 Added......................................................24816 Effective date confirmed.......................................33032 Technical correction...........................................40160 73.3121 (a)(7) through (9) addition effective date confirmed........2478 73.3122 Added......................................................11432 Effective date confirmed.......................................21911 73.3123 Added......................................................11436 Effective date confirmed.......................................19543 73.3124 Added......................................................11433 Effective date corrected.......................................12607 Effective date confirmed.......................................21911 73.3125 Added......................................................24816 Effective date confirmed.......................................33032 Technical correction...........................................40160 73.3126 Added......................................................24816 Effective date confirmed.......................................33032 Technical correction...........................................40160 74 Authority citation revised...............................28346, 28363 74.705 (a)(1) and (b) revised......................................24519 Effective date confirmed.......................................39654 74.706 Added.......................................................41782 74.1206 (b) and (c) revised (eff. 4-22-86)..........................9784 (b) and (c) revision effective date confirmed..................18883 74.1267 Added......................................................28346 Technical correction...........................................35509 Effective date revised.........................................35511 74.1308 Added......................................................43898 74.1309 Added......................................................43898 74.1319 Added......................................................28363 Effective date revised.........................................35511 74.1705 (a) and (b) revision effective date deferred...........376, 7934 (a) and (b) revision effective date deferred...................16675 (a) and (b) revision eff. 10-7-85..............................24519 (a) revised....................................................24519 Effective date confirmed.......................................39654 74.1706 Added......................................................41782 74.2206 (a) revised (eff. 4-22-86)..................................9784 (a) revision effective date confirmed..........................18883 74.2267 Added......................................................28346 Technical correction...........................................35509 Effective date revised.........................................35511 [[Page 214]] 74.2308 Added......................................................43898 74.2309 Added......................................................43898 74.2319 Added......................................................28363 Effective date revised.........................................35511 74.2705 Revision effective date deferred.......................376, 7934 Revision effective date deferred...............................16675 Revision eff. 10-7-85..........................................24519 (a) revised.............................................24519, 24524 Effective date confirmed.......................................39654 74.2706 Added......................................................41782 74.3045 (b) amended................................................22929 (c)(1)(iii) removed............................................28930 (b) amendment confirmed........................................32453 (c)(2) revised.................................................39371 (c)(1)(iii) removal confirmed..................................46852 74.3106 (c)(3) removal effective date confirmed.....................5990 74.3206 (a), (b) and (c) revised (eff. 4--26--86)...................9784 (a), (b), and (c) revision effective date confirmed............18883 (b) revised; (c)(3) removed....................................37909 81.1 (a) table amended.........................................376, 7934 (a) table amended..................16675, 24524, 31324, 39857, 41783 (a) and (b) tables amended................20786, 28364, 35511, 43900 (b) table amended.........................20787, 28346, 28363, 43899 Technical correction...........................................35509 Effective date confirmed................................35510, 39654 81.10 (q) redesignated as (q)(1); (q)(2) added.....................20787 (t) added......................................................43899 81.25 (a)(1) and (c)(1) amended; (b)(1)(ii) removed; (a)(2), (b)(2), and (c)(2) revised.................................43899 81.27 (d) introductory text table amended...........................376, 7934, 16675, 20786, 20788, 24524, 28346, 28363, 28364, 31324, 35511, 39857, 41783, 43899, 43900 Technical correction...........................................35509 Effective date confirmed.......................................39654 81.30 (r)(2) revised; (r)(3) added.................................20788 (s) added......................................................43899 82 Authority citation corrected....................................11014 Authority citation revised..............................28346, 28363 82.705 Revision effective date deferred.................376, 7934, 16675 Revision eff. 10-7-85..........................................24519 Revised........................................................24519 Effective date confirmed.......................................39654 82.706 Revised.....................................................41783 82.1206 (a) amended (eff. 4-22-86)..................................9785 Amendment effective date confirmed.............................18883 82.1267 Revised....................................................28346 Technical correction...........................................35509 82.1308 Revised....................................................43899 82.1309 Revised....................................................43899 82.1319 Revised....................................................28363 82.1337 Removed....................................................20788 101 Authority citation revised; section authority citations removed....................................................25017 101.100 (a)(4) added...............................................25017 101 Appendix A added...............................................25017 107.50 (Subpart C) OMB number.......................................6106 110 Revised........................................................22475 118 Removed........................................................22481 123 Removed........................................................41616 131.110 (b), (c)(1), and (e)(1)(i) eff. 1-5-87.....................40314 131.135 (b), (c)(1), and (3), and (e)(1)(ii) eff. 1-5-87...........40314 131.143 (b), (c)(1) and (3), and (e)(1)(i) eff. 1-5-87.............40314 133 Authority citation revised.....................................30210 133.146 (b)(2) revised.............................................30210 Effective date confirmed.......................................42088 145.170 (b) revision effective date confirmed......................11434 160 Authority citation revised.....................................11435 160.145 (a) revised; (c) redesignated as (d); new (c) and (e) added......................................................11435 Eff. 7-1-87....................................................25362 172.210 (b)(2) table amended........................................2693 172.515 (b) amendment confirmed; request for deferral denied.......37909 172.804 (c) (8) and (9) added......................................43000 (c)(10) added..................................................43001 (c)(5)(ii) amended; (c)(11) added..............................43002 172.834 Technical correction........................................1495 172.846 Introductory text corrected...........................1495, 3333 172.859 (a) amended; (b)(10) and (11) added........................40161 172.886 (c)(2) revised.............................................19544 173.5--173.75 (Subpart A) Heading revised..........................11719 173.45 Added........................................................5315 173.60 Technical correction.........................................1495 173.75 Added.......................................................11720 [[Page 215]] 175 Authority citation revised; section authority citations removed....................................................19545 175.105 (c)(5) table amended.........5316, 19545, 30059-60, 31099, 33889 Technical correction...............................1495, 6520, 43120 175.250 (a) amended; (b)(1) revised................................47010 175.300 (b)(3)(xxxi) amended........................................4312 176.170 (b)(2) table amended...........................881, 28546, 47011 Technical correction............................................1495 176.180 (b)(2) table amended.........................16167, 17012, 47011 176.300 (c) table amended..........................................19059 (d) amended....................................................43734 177.1310 (a) and (b) revised; (c) redesignated as (d); new (c) added......................................................19060 177.1315 (b) revised...............................................22929 177.1500 (a)(10) revised; (b) table amended........................33250 177.1520 (b) table amended.........................................43191 (a)(3)(i)(b) and (c) amended; (a)(3)(i)(d) added...............45315 177.1630 (e)(4) amended.............................................3772 177.1655 Added.......................................................882 (b) table and (d) corrected.....................................4165 177.1810 (b) table and (c)(3) revised..............................16828 Technical correction...........................................18774 177.2500 Removed.....................................................883 178 Authority citation revised; section authority citations removed....................................................19544 Authority citation corrected...................................43120 178.1005 (e)(1) revised............................................45881 178.1010 (b)(29) and (c)(24) added..................................7437 (b)(30) and (c)(25) added.......................................7438 (b)(31) and (c)(26) added......................................33892 (b)(33) and (c)(28) added......................................47226 178.2010 (b) table amended......5317, 12608, 19061, 29462, 31100, 32212, 35512, 47012 (b) table corrected.....................................15763, 39372 Technical correction......................................1495, 6520 178.3130 (b) table amended.........................................28932 178.3297 (e) table amended...................................7552, 19168 (e) table corrected............................................23535 178.3400 (c) table amended.........................................31763 Technical correction...........................................39747 178.3570 (a)(3) table amended.......................................7552 178.3710 (f) added.................................................19545 178.3740 (b) table amended.........................................47011 178.3770 (c) added.................................................33895 179 Authority citation revised.....................................13398 179.21 Authority citation removed..................................13398 179.22 Removed.....................................................13398 179.24 Removed.....................................................13398 179.25 Added.......................................................13399 179.26 Added.......................................................13399 179.45 Authority citation removed..................................13398 182 Authority citation revised..............................16830, 25025 182.70 Amended..............................................16830, 27171 Effective date corrected.......................................18774 182.90 Amended.....................................................39372 182.1366 Removed...................................................27171 182.3616 (c) revised...............................................25025 Effective date corrected.......................................25198 Technical correction...........................................26876 182.3637 (c) revised...............................................25025 Effective date corrected.......................................25198 Technical correction...........................................26876 182.3739 (c) revised...............................................25025 Effective date corrected.......................................25198 Technical correction...........................................26876 182.3766 (c) revised...............................................25025 Effective date corrected.......................................25198 Technical correction...........................................26876 182.3798 (c) revised...............................................25026 Effective date corrected.......................................25198 Technical correction...........................................26876 182.3862 (c) revised...............................................25026 Effective date corrected.......................................25198 Technical correction...........................................26876 184 Authority citation corrected....................................1495 184.1157 Added.....................................................27173 184.1318 Added.....................................................33896 184.1366 (c), (d), and (e) revised.................................27172 186 Authority citation revised; section authority citations removed....................................................16830 186.1557 Added.....................................................16830 Effective date corrected.......................................18774 186.1770 Added.....................................................39372 186.1771 Added.....................................................39372 189.113 Addition confirmed; request for deferral denied............37909 193.35 Removed.....................................................25686 193.110 Removed....................................................46617 193.120 Removed....................................................46617 193.137 Added......................................................11437 193.186 (b) table amended..........................................31325 193.450 Revised....................................................46617 193.468 (c) added..................................................28224 201 Authority citation revised........................8182, 41783, 43904 201.20 (a) revised.................................................41783 [[Page 216]] 201.22 Added; eff. 6-3-87..........................................43904 201.314 (h) added; eff. 6-5-86......................................8182 207 Authority citation revised......................................7389 207.10 (f) revised; eff. 5-2-86.....................................7389 210 Heading and authority citation revised; eff. 5-2-86.............7389 210.3 (b) (13) and (14) revised; eff. 5-2-86........................7389 211 Authority citation revised.....................................24479 211.198 (a) amended................................................24479 Technical correction...........................................28810 225 Authority citation revised......................................7389 225.1 (b) revised; eff. 5-2-86......................................7389 225.58 (b)(1) amended; (b)(2) removed; (c) revised; eff. 5-2-86.....7390 225.115 (b)(2) amended; eff. 5-2-86.................................7390 225.120--225.135 (Subpart F) Added; eff. 5-2-86.....................7390 225.142--225.165 (Subpart G) Added; eff. 5-2-86.....................7390 225.180 (Subpart H) Added; eff. 5-2-86..............................7390 225.202 (Subpart I) Added; eff. 5-2-86..............................7390 226 Heading and authority citation revised; nomenclature change; eff. 5-2-86.................................................7390 310 Authority citation revised.....................................24479 310.305 Added......................................................24479 Technical correction...........................................28810 310.534 Added; eff. 7-18-87........................................26114 314.80 (a) amended.................................................24481 Technical correction...........................................28810 330 Authority citation revised.....................................16265 330.1 (c) redesignated as (c)(1); (c)(2) added.....................16266 Technical correction...........................................18580 330.2 Authority citation removed...................................16265 330.10 Authority citation removed..................................16265 330.13 Authority citation removed..................................16265 331 Authority citation revised.....................................16266 331.11 (k)(1) amended..............................................27763 Technical correction...........................................32212 331.30 (b) revised.................................................16266 Technical correction....................................18580, 32212 (g) added......................................................27763 332 Authority citation revised.....................................16266 332.30 (a) revised.................................................16266 Technical correction....................................18580, 32212 (c) added......................................................27763 341 Added; eff. 10-2-87............................................35339 344 Added; eff. 8-10-87............................................28660 357 Authority citation revised.....................................16267 357.101--357.180 (Subpart B) Added (effective date pending in part)......................................................27759 357.250 (b) revised................................................16267 Technical correction...........................................18580 369 Authority citation revised.....................................27759 Correctly designated...........................................31763 369.20 Amended.....................................................27760 Amended; eff. 10-2-87..........................................35340 430.4 (a)(55) added................................................11571 430.5 (a)(87) and (b)(89) added....................................11571 (a)(88) and (b)(90) added......................................20263 430.6 (b)(89) added................................................11572 (b)(90) added..................................................20263 433 Authority citation revised.....................................25524 433.1 Revised; authority citation removed..........................25524 (a) corrected..................................................30478 Technical correction...........................................33897 433.2 (b) revised; authority citation removed......................25524 Technical correction...........................................33897 436.200 (i) added..................................................11572 436.201 (c)(3)(iii) redesignated as (c)(3)(iv) and revised; (b)(3)(iii) and new (c)(3)(iii) added......................22071 (b)(1) amended.................................................27532 436.215 (a), (b), and (d) revised; (c)(7) added....................22072 (b) table amended; (c)(8) added................................37721 436.216 Added......................................................11572 436.360 (c)(3) corrected............................................1367 436.545 Added......................................................37721 440 Authority citation revised.....................................27532 440.13a (a)(1)(vi) amended.........................................27532 441 Added..........................................................11573 441.20a (a)(3)(i) and (b)(1) introductory text, (i)(a), (d), (ii) heading and (a) corrected; (b) (2) through (6) correctly added......................................................16517 441.220 (b)(1)(ii)(a) corrected....................................22275 442 Authority citation revised; section authority citations removed....................................................20263 442.12 Added.......................................................36688 442.14a (b)(1) revised.............................................27532 442.16a (b)(4) corrected............................................2478 442.53a Added......................................................20263 442.212 Redesignated as 442.212a; new 442.212 added................36688 442.212a Redesignated from 442.212.................................36688 [[Page 217]] 442.212b Added.....................................................36688 442.216 (a)(3)(i)(b) and (b)(1)(ii)(a) corrected....................2478 442.253 Added......................................................20264 448.510f Added.....................................................35212 449.150d Added......................................................4617 452.32a Added......................................................35215 452.110d Added.....................................................37723 452.232 Redesignated as 452.232a; new 452.232 added................35216 452.232a Redesignated from 452.232.................................35216 452.232b Added.....................................................35216 452.910 (Subpart J) Added..........................................35213 455.185 Redesignated as 455.185a; new 455.185 added................22072 455.185a Redesignated from 455.185.................................22072 455.185b Added.....................................................22072 510.6 (d)(3), (e), and (f) amended; eff. 5-2-86.....................7391 510.305 Introductory text and (a) amended; eff. 5-2-86..............7391 510.455 Revised....................................................19827 510.505 Removed....................................................30211 510.520 (a) introductory text amended..............................30211 510.600 (c)(1) and (2) tables amended...............................594, 5990, 5991, 11438, 11439, 18883, 19829, 22799, 28546, 29916, 31100, 33897, 47013 Effective date corrected to 12-13-85............................8315 514 Authority citation revised......................................7391 514.1 (e) removed; (b)(3)(v)(a) and (b), (5)(vii)(a) and (x) revised; OMB number; eff. 5-2-86............................7391 514.2 Revised; eff. 5-2-86..........................................7391 514.9 (c) amended; eff. 5-2-86......................................7391 514.55 Amended; eff. 5-2-86.........................................7391 514.105 (b) amended; eff. 5-2-86....................................7392 514.112 Added; eff. 5-2-86..........................................7392 520 Authority citation corrected...................................42163 520.314 (c) introductory text, (1), (2), and (3) redesignated as (c)(1) introductory text, (i), (ii), and (iii); new (c)(2) added.......................................................4165 520.446 (c) revised................................................34960 520.447 (c) revised................................................34960 520.580 Effective date corrected to 12-13-85........................8315 520.600 (c) amended................................................28546 520.905e Added.....................................................41783 520.1192 (a) revised; (c)(1) redesignated as (c)(1)(i) and revised; (c)(2) and (3) redesignated as (c)(1)(ii) and (iii); new (c)(2) added....................................44449 520.1236 (a) revised...............................................42834 520.1242f (d)(1), (2), and (3) redesignated as (d)(1) (i), (ii), and (iii); new (d)(2) added; (d) introductory text redesignated as new (d)(1) heading and revised.............29215 520.1326 Redesignated as 520.1326a and heading revised; new 520.1326 added.............................................13212 520.1326a Redesignated from 520.1326 and heading revised...........13212 520.1326b Added....................................................13212 520.1450a (d)(3) amended............................................9005 520.1450b (d) revised..............................................23415 (d)(3) amended.................................................41081 520.1468 (c)(1) revised............................................24525 520.2043 (b)(4) added..............................................11440 520.2260b (f) and (g) added........................................30212 520.2455 (b) amended...............................................28546 520.2473a (c)(1)(ii) corrected......................................2693 520.2480 (a) and footnote 1 removed; (b) and (c) redesignated as (a) and (b); new (c) added; (d)(1) and (2) amended; (d)(3) and (4) revised............................................26002 520.2481 (a) removed; (b) and (c) redesignated as (a) and (b); (c) and (d)(4) added; new (b) and (d)(3) revised...............26002 520.2482 (c) redesignated as (d); new (c) added; new (d)(3) revised....................................................26002 522 Heading corrected..............................................19545 Authority citation corrected...................................20646 Authority citation revised.....................................25032 522.234 (b) amended................................................19329 522.840 Revised....................................................22276 522.850 (c)(2) revised.............................................33592 522.940 (d) removed................................................14989 (c)(1) amended.................................................18314 522.1044 (b)(3) and (d)(5) added...................................15606 522.1145 Heading, (a), and (b) revised.............................11438 (a), (b), and (c) (1), (2), and (3) redesignated as (a) (1), (2), and (3) (i), (ii), and (iii); new (b) added...................25032 522.1192 (d)(2) (ii) and (iii) revised.............................25686 (a)(2) heading revised; (d)(4) added...........................27021 [[Page 218]] (d)(4)(ii) corrected....................................28932, 29463 522.1410 (b) revised.................................................741 522.1468 Removed; new 522.1468 redesignated from 522.1468b and heading and (c)(2) revised.................................24525 522.1468a Removed..................................................24525 522.1468b Redesignated as 522.1468 and heading and (c)(2) revised 24525 522.1662a (a)(2) and (g)(2) amended................................28547 522.1881 Removed...................................................35632 522.1940 (d)(1) (ii) and (iii) amended.............................21746 Technical correction...........................................25198 522.2063 (b) revised; (c)(2) redesignated as (c)(2)(i); new (c)(2)(ii) added...........................................41477 522.2470 (b) amended...............................................24142 522.2615 Added.....................................................44450 529 Authority citation revised.......................................594 529.1030 Added.....................................................11441 529.1186 Added.......................................................594 529.2503 (b) amended...............................................11439 540 Authority citation revised......................................4484 540.103g (c)(3)(i)(b) and (c) revised...............................4484 (a)(1) amended; (c)(3)(ii) added................................5318 540.103h Added......................................................4483 (c)(3)(ii) added................................................5317 (a)(1) corrected................................................6218 546 Authority citation revised.....................................28547 546.110c (c)(2) amended............................................28547 546.180d (c)(5) revised; (c)(6)(iv)(c) added.......................44451 548.314a (a)(1)(i) and (ii) and (c)(2)(i) and (ii) amended.........19546 548.314b (a)(1) and (2) amended....................................19546 555 Authority citation revised......................................1367 555.110b (c)(2)(i) amended.........................................11441 555.110c Removed....................................................1367 556.344 Revised....................................................27021 556.425 Revised.....................................................9005 556.428 Added......................................................29097 556.490 Revised....................................................18884 556.640 (a) revised................................................18884 (d) table amended..............................................29097 558 Authority citation revised......................................6910 Authority citation corrected....................................7064 558.3 Revised; eff. 5-2-86..........................................7392 558.4 Revised; eff. 5-2-86 and 3-3-87...............................7392 (d) table corrected.............................................9005 (d) table amended; eff. 5-2-86..................................9190 558.15 (g) introductory text and (2) introductory text revised; eff. 5-2-86.................................................7394 Revised; eff. 4-14-86...........................................8811 (g)(1) table corrected.........................................11014 (g)(1) and (2) tables amended..................................28547 558.20 Added; eff. 5-2-86...........................................7394 558.35 (a), (b), (d), and (e) removed; (c), (f), and (g) redesignated as (a), (b), and (c); new (a) introductory text revised; eff. 5-2-86...................................7395 Technical correction............................................9005 558.45 (b), (c), (d), and (e) removed; (f) redesignated as (b); (a) revised; eff. 5-2-86....................................7395 558.55 (a) revised; (b) removed; (c), (d), and (e) redesignated as (b), (c), and (d); new (b) revised; eff. 5-2-86.............7395 558.58 (b) removed; (c), (d), and (e) redesignated as (b), (c), and (d); (a), new (b), and (d) introductory text revised; eff. 5-2-86.................................................7395 558.59 Added........................................................9190 558.60 (a) added; (b) and (c) removed; (d) and (e) redesignated as (b) and (c); new (c)(1) introductory text revised; eff. 5- 2-86........................................................7395 (a) amended....................................................33897 558.62 (a) added; (b) and (c) removed; (d) and (e) redesignated as (b) and (c); new (c)(1) introductory text revised; eff. 5- 2-86........................................................7395 (a) amended....................................................33897 558.76 (b) removed; (c), (d), and (e) redesignated as (b), (c), and (d); (a), new (b), and (d)(1) introductory text revised; eff. 5-2-86........................................7396 558.78 (b) removed; (c), (d) and (e) redesignated as (b), (c) and (d); (a), new (b), and (d)(1) introductory text revised; eff. 5-2-86.................................................7396 (d)(3)(x) added................................................18314 (d)(3)(x) revised..............................................29463 558.95 (b), (c), and (d) removed; (e) redesignated as (b); (a), and new (b)(1) introductory text and (2) introductory text revised; eff. 5-2-86........................................7396 558.105 (b) and (c) removed; (d), (e), and (f) redesignated as (b), (c), and (d); (a), new (b), and (d) introductory text revised; eff. 5-2-86........................................7396 [[Page 219]] 558.115 (b) and (c) removed; (d), (e) and (f) redesignated as (b), (c) and (d); (a), new (c), and (d) introductory text revised; eff. 5-2-86........................................7396 558.120 (a) added; (b) and (c) removed; (d) and (e) redesignated as (b) and (c); new (c)(1) introductory text revised; eff. 5-2-86......................................................7396 558.128 (b) and (c) removed; (d) and (e) redesignated as (b) and (c); (a) revised; eff. 5-2-86...............................7396 558.145 (c) and (d) removed; (e) and (f) redesignated as (c) and (d); (a) and (b) revised; eff. 5-2-86.......................7396 558.155 (c) and (d) removed; (e) and (f) redesignated as (c) and (d); (a), (b), and new (d) introductory text revised; eff. 5-2-86......................................................7397 (a) (1) and (2) amended........................................28547 558.175 (b) and (c) removed; (d) and (e) redesignated as (b) and (c); (a) revised; eff. 5-2-86...............................7397 558.185 (b) and (c) removed; (d), (e) and (f) redesignated as (b), (c) and (d); (a) and new (b) revised; eff. 5-2-86...........7397 558.195 (b), (c), and (d) removed; (e), (f), and (g) redesignated as (b), (c), and (d); (a) revised; eff. 5-2-86..............7397 (a) and (d) table amended......................................34589 558.205 (b) and (c) removed; (d), (e) and (f) redesignated as (b), (c) and (d); (a) revised; eff. 5-2-86.......................7397 (a) amended....................................................28547 558.240 (b) and (c) removed; (d) and (e) redesignated as (b) and (c); (a) added..............................................7397 558.248 (b) removed; (c), (d), and (e) redesignatated as (b), (c), and (d); (a), new (b), and (d)(1) introductory text revised; eff. 5-2-86........................................7397 558.254 (b) removed; (c), (d), and (e) redesignated as (b), (c), and (d); (a) added; eff. 5-2-86.............................7397 558.258 (b) removed; (c) and (d) redesignated as (b) and (c); (a) revised; eff. 5-2-86........................................7397 558.262 (b) and (c) removed; (d) and (e) redesignated as (b) and (c); (a) added; eff. 5-2-86.................................7397 558.265 (b) removed; (d) and (e) redesignated as (b) and (c); (a) revised; eff. 5-2-86........................................7397 (a) amended....................................................11439 (c) (3) and (4) added..........................................14989 (c) (2), (3), and (4) introductory texts revised...............23737 558.274 (b) and (c) removed; (d) and (e) redesignated as (b) and (c); (a) revised; eff. 5-2-86...............................7398 (c)(1) table amended; (a)(8) added.............................19547 558.305 (b), (c), and (e) removed; (d) and (f) redesignated as (b) and (c); (a) and new (c) introductory text revised; eff. 5-2-86......................................................7398 558.311 (b)(3) amended; (f)(11) added...............................5163 (f) table corrected.............................................7064 (b) and (c) removed; (d), (e), and (f) redesignated as (b), (c), and (d); (a) revised; eff. 5-2-86..............................7398 (a) (1) and (3) and (d) table amended..........................37271 558.315 (b), (c), (d), and (f) removed; (e) and (g) redesignated as (b) and (c); (a) and new (c) introductory text revised; eff. 5-2-86.................................................7398 558.325 (b), (c) and (e) removed; (d) and (f) redesignated as (b) and (c); (a) revised; eff. 5-2-86...........................7398 (a) revised; (c)(2)(v) added...................................12137 (a) and (c)(2)(v) correctly designated; (a) introductory text, (1)(i), (ii), and (iii), and (2), (4), (5), (6), and (8) through (15) corrected.....................................................28547 558.342 (b) and (c) removed; (d) and (e) redesignated as (b) and (c); (a) revised; eff. 5-2-86...............................7398 (c)(2)(ii) revised.............................................36222 558.355 (a), (d) (3) and (4) removed; (b) introductory text and (c) revised; eff. 5-2-86....................................7398 (b)(12) and (f)(1)(xxii) added.................................16676 (b)(11) revised; (f)(1)(xxiii) added...........................32631 (f)(3)(iv)(b) revised..........................................36222 (f)(1)(xii)(b) amended.........................................36392 (b)(11) revised; (f)(1)(xxiv) added............................45105 [[Page 220]] 558.360 (b) removed; (c), (d), and (e) redesignated as (b), (c), and (d); (a) and new (c)(1) revised; eff. 5-2-86............7399 (d)(3) amended..................................................9005 558.363 Added......................................................29098 558.365 (b) and (c) removed; (d), (e), and (f) redesignated as (b), (c), and (d); (a) and new (c) revised; eff. 5-2-86.....7399 558.366 (b) and (d) removed; (c) and (e) redesignated as (b) and (c); (a) revised; eff. 5-2-86...............................7399 558.367 (b) removed; (c) redesignated as (b); (a) revised; eff. 5- 2-86........................................................7399 558.369 (b) and (c) removed; (d), (e), and (f) redesignated as (b), (c), and (d); (a) revised; eff. 5-2-86.................7399 558.370 (a) added; (b) and (c) removed; (d) redesignated as (b); eff. 5-2-86.................................................7399 558.376 (b) and (c) removed; (d) and (e) redesignated as (b) and (c); (a) added; eff. 5-2-86.................................7399 558.415 (b), (c), and (d) removed; (e) and (f) redesignated as (b) and (c); (a) revised; eff. 5-2-86...........................7399 558.430 (b) and (c) removed; (d) and (e) redesignated as (b) and (c); (a) added; eff. 5-2-86.................................7399 558.435 (b) and (c) removed; (d), (e) and (f) redesignated as (b), (c) and (d); (a) and new (c) revised; eff. 5-2-86...........7399 558.450 (b) removed; (c), (d), and (e) redesignated as (b), (c), and (d); (a) and new (b) revised; eff. 5-2-86...............7399 (d)(1) Table 1 amended.........................................16676 558.460 (b), (c), and (d) removed; (e) and (f) redesignated as (b) and (c); (a) revised; eff. 5-2-86...........................7399 558.464 (b) removed; (c) redesignated as (b); (a) revised...........7399 558.465 (b) and (c) removed; (d) redesignated as (b); heading and (a) revised; eff. 5-2-86....................................7399 558.485 (b) removed; (a) introductory text and (d) revised; eff. 5-2-86......................................................7400 (a)(27) added..................................................33898 Technical correction...........................................43121 558.515 (b) and (c) removed; (d), (e), and (f) redesignated as (b), (c), and (d); (a) revised; new (b) amended; eff. 5-2- 86..........................................................7400 558.525 (b) and (c) removed; (d), (e), and (f) redesignated as (b), (c), and (d); (a) revised; eff. 5-2-86.................7400 558.530 (b) and (c) removed; (d), (e), and (f) redesignated as (b), (c), and (d); (a) revised; eff. 5-2-86.................7400 (d)(4) (iii) and (iv) added....................................29463 (a)(1) amended.................................................44055 558.550 (b) revised; (c)(2) redesignated as (c)(3); new (c)(2) added........................................................595 (c)(1)(vi) added................................................6911 (b) removed; (c) redesignated as (b); (a) revised; eff. 5-2-86 7400 (b)(1)(vii) added..............................................18314 (b)(1)(viii) added.............................................29463 (b)(1)(ix) added...............................................31764 558.575 (b) and (c) removed; (d) and (e) redesignated as (b) and (c); (a) revised; eff. 5-2-86...............................7400 (c)(6) added...................................................18884 558.579 (a) added; (b) and (c) removed; (d) and (e) redesignated as (b) and (c); eff. 5-2-86.................................7400 558.582 (a) added; (b) and (c) removed; (d) and (e) redesignated as (b) and (c); eff. 5-2-86.................................7400 558.586 (b) and (c) removed; heading revised; (a) added; eff. 5-2- 86..........................................................7400 558.615 (b) removed; (c), (d), and (e) redesignated as (b), (c), and (d); (a) and new (b) revised; eff. 5-2-86...............7400 558.625 (b)(86) added...............................................5991 (c) and (d) removed and reserved; (b) introductory text revised; eff. 5-2-86................................................7400 (b)(25) amended.................................................7785 (b)(6) removed.................................................11439 (b)(87) added..................................................22799 (b)(88) added..................................................26378 558.630 (b)(3) and (10) amended.....................................3333 (b)(10) amended.................................................5992 (a), (c), and (d) removed; (b) introductory text revised; eff. 5-2-86..............................................................7400 (b)(3) amended..................................................7785 (b)(10) amended................................................19829 (b)(8) and (10) amended........................................34961 [[Page 221]] 558.635 (f)(2)(ii) revised..........................................7262 (a), (c), and (e) (3) and (4) removed; (b) revised; eff. 5-2- 86..................................................................7400 (f)(3)(v) added................................................14990 558.680 (a) revised; (b) and (c) removed; (d) and (e) redesignated as (b) and (c); eff. 5-2-86.................................7401 561.92 Revised......................................................9439 Corrected...............................................12138, 17174 561.120 Removed....................................................46617 561.260 (c) removed.................................................1785 561.370 Removed....................................................46618 561.432 (c) added..................................................28224 561.436 Added......................................................15317 Correctly designated...........................................19169 561.438 Added......................................................39655 570 Authority citation revised......................................5992 570.12 Removed......................................................5993 579 Added...........................................................5993 579.22 Correctly designated.........................................8315 601 Authority citation revised.....................................15607 601.25 (d)(2) amended..............................................15607 610 Authority citation revised................15607, 37450, 44453, 44906 610.9 (b) amended..................................................15607 610.11 Introductory text, (c) introductory text, (2), and (3) amended....................................................15607 610.12 (a)(1)(i), (e)(2), (f), and (g) (2) and (8) revised; (h) added......................................................44906 610.15 (a) introductory text amended...............................15607 610.18 (c) and (d) added; OMB number...............................44453 610.40 (b)(4), (d)(1)(v) and (2)(iv) amended.......................15607 610.53 (c) table revised...........................................15607 (c) table corrected............................................19750 (c) table amended..............................................37450 620 Authority citation revised.....................................15610 620.6 (h) amended..................................................15610 620.12 Introductory text amended...................................15610 620.14 (c) introductory text amended...............................15610 620.24 (c) introductory text amended...............................15610 620.35 (e) introductory text amended...............................15610 620.43 Amended.....................................................15610 620.48 (a) introductory text and (2) amended.......................15610 630 Authority citation revised.....................................15610 630.5 (c) introductory text amended................................15610 (c) introductory text corrected................................18580 630.10 (a) revised.................................................44454 630.12 (b) revised.................................................44454 630.13 (b)(1) revised; (c) removed.................................44454 630.16 (a)(6) amended..............................................15610 630.17 (e) introductory text amended...............................15610 630.36 (h) introductory text amended...............................15610 630.56 (f) introductory text amended...............................15610 630.66 (e) introductory text amended...............................15610 630.75 (d) introductory text amended...............................15610 630.86 (e) introductory text amended...............................15611 640.1 Amendments at 50 FR 4138 effective date deferred to 9-2-86 3773 640.3 (b) introductory text, (c) introductory text, (d), and (e) amended....................................................15611 640.10 Amendments at 50 FR 4138 effective date deferred to 9-2-86 3773 640.20 Amendments at 50 FR 4139 effective date deferred to 9-2-86 3773 640.30 Amendments at 50 FR 4139 effective date deferred to 9-2-86 3773 640.50 Amendments at 50 FR 4139 effective date deferred to 9-2-86 3773 640.101 (f) introductory text amended..............................15611 640.111 (g) introductory text amended..............................15611 650 Authority citation revised.....................................15611 650.11 (c) introductory text amended...............................15611 660 Authority citation revised.....................................15611 660.6 (a)(2) amended...............................................15611 660.22 Amended.....................................................15611 660.29 (a) introductory text amended...............................15611 660.30--660.36 (Subpart D) Revised; effective in part 10-7-88......37450 660.36 (a) introductory text amended...............................15611 660.42 Amended.....................................................15611 660.46 (a)(2) amended..............................................15611 [[Page 222]] 660.52 Amended.....................................................15611 660.53 Amended.....................................................15611 660.54 Introductory text amended...................................15611 660.101 Introductory text amended..................................15611 660.102 Introductory text amended..................................39637 660.103 (f)(1) revised.............................................39637 660.105 (a) introductory text amended..............................15611 (a)(1) revised.................................................39637 680 Authority citation revised.....................................15611 680.3 (e) and (f) added; OMB number................................37607 680.4 (c)(1) introductory text amended.............................15611 Removed........................................................37607 680.21 Amended.....................................................15611 680.26 Amended.....................................................15611 720 Authority citation revised.....................................11444 720.8 Revised......................................................11444 730 Authority citation revised; section authority citations removed....................................................25687 730.2 Revised......................................................25687 730.3 Revised......................................................25687 730.4 (a)(1) revised...............................................25687 740 Authority citation revised.....................................20475 740.17 Revised; eff. 6-5-87........................................20475 807 Authority citation revised.....................................33032 807.31 (c) revised.................................................33033 814 Added..........................................................26364 Technical correction...........................................34589 Authority citation revised.....................................43344 814.15 (b) heading correctly revised...............................40415 Amended (OMB number)...........................................43344 814.20 (b)(3)(v) introductory text corrected.......................40415 Amended (OMB number)...........................................43344 814.39 Amended (OMB number)........................................43344 814.82 Amended (OMB number)........................................43344 814.84 Amended (OMB number)........................................43344 868 Authority citation revised.....................................40388 868.5795 Added.....................................................40388 868.5800 Added.....................................................40389 874 Added..........................................................40389 882 Authority citation revised.....................................12101 882.5830 (c) added.................................................12101 Technical correction...........................................15883 884 Authority citation revised..............................16649, 39845 884.1600 (c) added.................................................39845 884.5360 (d) added.................................................16649 Chapter II 1301.03 Amended.....................................................5319 1301.24 (b) amended.................................................5319 1301.26 (e) amended.................................................5319 1301.32 (a)(7), (c) and (f) amended.................................5319 1301.33 (c) amended.................................................5319 1301.34 (a) amended.................................................5319 1301.61 Amended.....................................................5319 1301.64 Removed.....................................................5319 1301.71 (d) amended.................................................5319 1302 Authtority citation revised....................................5319 1303 Authority citation revised.....................................5319 1303.12 (b) and (d) amended.........................................5319 1303.22 Amended.....................................................5319 1303.27 Amended.....................................................5319 1304.03 (d) amended.................................................5319 (b) corrected..................................................26154 1304.04 (f) and (g) amended.........................................5320 1304.31 Removed; new 1304.31 redesignated from 1304.33..............5319 (a) amended.....................................................5320 1304.32 Removed; new 1304.32 redesignated from 1304.34..............5319 (a) amended.....................................................5320 1304.33 Redesignated as 1304.31; new 1304.33 redesignated from 1304.35.....................................................5319 1304.34 Redesignated as 1304.32.....................................5319 Redesignated from 1304.37 and amended...........................5320 (c) redesignated from 1304.36(c)................................5320 1304.35 Redesignated as 1304.33 and (a) amended.....................5319 Redesignated from 1304.38.......................................5320 1304.36 (a) and (b) removed.........................................5319 (c) redesignated as 1304.34(c)..................................5320 Redesignated from 1304.39.......................................5320 1304.37 Redesignated as 1304.34 and amended; new 1304.37 redesignated from 1304.40...................................5320 1304.38 Redesignated as 1304.35; new 1304.38 redesignated from 1304.41.....................................................5320 1304.39 Redesignated as 1304.36.....................................5320 1304.40 Redesignated as 1304.37.....................................5320 1304.41 (a) amended.................................................5319 Redesignated as 1304.38.........................................5320 1305.03 (c) amended.................................................5320 1305.05 (b) and (d) amended.........................................5319 1305.12 (b) amended.................................................5319 1306 Authority citation revised.....................................5319 1306.15 Amended.....................................................5320 [[Page 223]] 1306.23 Amended.....................................................5320 1306.25 Amended.....................................................5320 1306.31 (a) amended.................................................5320 1307.14 (a) amended.................................................5319 1308.02 (c) revised; (e) and (f) redesignated as (f) and (g); new (e) added..................................................15317 1308.03 (a) revised................................................15318 1308.04 (a) amended.................................................5320 1308.11 (g)(13) added...............................................4723 (b)(17) amended.................................................5320 (b)(17) correctly designated....................................9440 1308.11 (g)(1) effective date extended.............................15474 (g)(2) effective date extended.................................21912 (g)(3) and (4) effective date extended.........................28695 (g)(1) removed; (b)(31) through (46) and (g)(2) through (13) redesignated as (b)(32) through (47) and (g)(1) through (12); new (b)(31) added......................................................33593 (d)(7) through (24) redesignated as (d)(8) through (25); new (d)(7) added; (g)(1) removed; (g)(2) through (12) redesignated as (g)(1) through (11)................................................36560 (g)(5) through (12) addition at 50 FR 43700 effective date extended...........................................................42834 1308.12 (b)(4) revised.............................................15318 (f) redesignated as (g); new (f) added.........................17478 1308.13 (e)(3) and (4) amended......................................5320 1308.14 (c)(3) table revised.......................................10191 1308.24 Amended.....................................................5319 1308.52 Added......................................................15318 1311 Authority citation revised.....................................5319 1311.03 Amended.....................................................5319 1311.32 (c) and (f) amended.........................................5319 (b) and (c) amended.............................................5320 1311.61 Amended.....................................................5319 1311.64 Removed.....................................................5320 1312 Authority citation revised.....................................5319 1312.02 (a) amended.................................................5320 1312.12 (a) amended...........................................5319, 5320 1312.14 (a) amended.................................................5319 1312.16 (b) amended.................................................5319 1312.18 (b) amended.................................................5319 1312.19 (a) and (b) amended.........................................5319 1312.22 (a) amended.................................................5319 1312.24 (a) amended.................................................5319 1312.25 Amended.....................................................5319 1312.27 (a) amended.................................................5319 1312.28 (c) and (d) amended.........................................5319 1312.31 (b) amended.................................................5319 1312.32 (a) amended.................................................5319 1316 Authority citation revised.....................................5319 1316.03 (d) amended.................................................5319 1987 21 CFR 52 FR Page Chapter I 2.125 (e)(11) added................................................15717 5 Authority citation revised........................................5951 Corrected.......................................................7969 5.22 (a)(9)(v) and (vi) added......................................41986 5.31 (a) introductory text revised; (a)(3) added....................2514 5.44 Added..........................................................7269 5.61 (b)(2) redesignated as (b)(3); (b)(1) and (d)(3) revised; (b)(2) added................................................5951 5.71 (a)(1)(ii) redesignated as (a)(1)(iii); (a)(1)(ii) and (iv) added.......................................................7829 5.80 (b)(1) and (c) introductory text revised; (d) added...........37764 5.86 Revised.......................................................29664 5.87 Revised.......................................................29664 5.93 Added.........................................................10881 5.94 Added..........................................................2514 5.100 Revised.......................................................6970 5.115 Amended.......................................................6971 10.40 (h) revised..................................................36401 10.95 (d)(8) revised...............................................35064 58 Authority citation revised......................................33779 Technical correction...........................................36863 58.1 Existing text designated as (a); (b) added....................33779 58.3 Nomenclature change; (c), (d), and (e)(8) revised; (e)(12) removed; (e)(17) and (18) amended; (o) and (p) added.......33779 58.31 (b) revised..................................................33780 58.35 (a) and (b) introductory text, (1), and (3) revised; (e) removed; OMB number........................................33780 58.41 Revised......................................................33780 58.43 (c) amended; (e) removed.....................................33780 58.45 Amended......................................................33780 58.49 Revised......................................................33780 58.53 Removed......................................................33780 58.61 Revised......................................................33780 58.63 (b) revised; OMB number......................................33780 58.81 (c) amended..................................................33780 58.90 (b) and (c) revised; OMB number..............................33780 [[Page 224]] 58.105 (a) amended; (b) revised; OMB number........................33781 58.113 (a)(2) revised..............................................33781 58.120 (a) revised; OMB number.....................................33781 58.130 (d) and (e) revised; OMB number.............................33781 58.185 (b) revised.................................................33781 58.190 (a) and (e) revised; OMB number.............................33781 58.195 (c) revised; (g) redesignated as (h); new (g) added.........33781 70 Authority citation revised......................................49586 70.50 (c) added....................................................49586 73.1496 (a)(1), (b), and (c) revised...............................29665 Technical correction...........................................32644 (a)(1), (b), and (c) revision effective date confirmed.........42429 74.102 Eff. 7-31-87................................................28553 74.706 Addition effective date confirmed; (a)(1) revised...........21508 (a)(1) revision effective date confirmed.......................31990 74.1102 Eff. 7-31-87...............................................28553 74.1267 Preamble clarification......................................5081 74.1308 Effective date corrected.....................................902 74.1309 Effective date corrected.....................................902 (a)(1) revised.................................................21305 Technical correction...........................................24583 Effective date confirmed.......................................28552 74.1319 Preamble clarification......................................5083 74.1706 Addition effective date confirmed; (c)(2) revised..........21508 74.2267 Preamble clarification......................................5081 74.2308 Effective date corrected.....................................902 74.2309 Effective date corrected.....................................902 74.2319 Preamble clarification......................................5083 74.2706 Addition effective date confirmed..........................21506 74.3045 Technical correction........................................3224 (c)(2) revision effective date confirmed........................7829 (c)(1) introductory text and (i) revised.......................15945 Effective date confirmed.......................................27542 74.3206 (b) revision and (c)(3) removal effective date confirmed 1902 Technical correction............................................7261 74.3602 Added......................................................19722 74.3710 Added......................................................28690 Addition effective date confirmed..............................45938 81 Authority citation revised......................................42098 81.1 Effective date corrected........................................902 (a) and (b) tables amended...............................3224, 10882 Preamble clarification....................................5081, 5083 (b) table amended............6323, 15946, 21305, 25209, 33574, 42098 (a) table amendment effective date confirmed; (a) table amended............................................................21509 Technical correction...........................................24583 (a) table amended..............................................42097 81.10 Effective date and (t) corrected...............................902 81.25 Effective date corrected.......................................902 81.27 Effective date corrected.......................................902 (d) introductory text table amended.......................3224, 6323 10882, 15946, 21306, 21509, 25209, 33574, 42097, 42098 Preamble clarification....................................5081, 5083 (d) introductory text table amendment effective date confirmed 21509 Technical correction...........................................24583 81.30 Effective date and (s)(1) and (2) corrected....................902 82.102 Eff. 7-31-87................................................28553 82.706 Revised.....................................................21509 82.1267 Preamble clarification......................................5081 82.1308 Effective date corrected.....................................902 82.1309 Effective date corrected.....................................902 82.1319 Preamble clarification......................................5083 101 Authority citation corrected....................................6971 101.9 (c)(3) amended...............................................28691 131 Stay terminated................................................29509 Technical correction...........................................31123 172.210 (b)(4) table amended.......................................18911 172.859 (a) amended................................................10883 173.357 (a)(2) table amended.......................................39512 175.105 (c)(5) table amended..................10884, 12380, 27800, 29180 (c)(5) table corrected.........................................19857 175.300 (b)(3)(xxxii) amended......................................41987 176.170 (b)(2) table amended..................................530, 19724 (a)(5) table amended................3604, 17553, 29667, 43058, 46746 Technical correction............................................6649 177 Authority citation revised..............................33803, 39635 177.1040 (c) table amended.........................................33803 177.1390 Heading revised...........................................33575 [[Page 225]] 177.1395 Added.....................................................33575 Technical correction...........................................36863 177.1430 Revised...................................................11641 177.1500 (a)(12) added; (b) table amended..........................26667 Technical correction...........................................28067 (a)(4) revised; (b) table amended..............................33575 (a)(13) and (c)(5) added; (b) table amended....................39635 (b) table corrected............................................42760 177.1520 (b) table amended.........................................23804 177.1555 Added.....................................................35540 177.1630 (e)(4)(i) amended.........................................32917 177.1660 (c)(1) amended............................................20069 177.2470 (a) revised; (b)(1) amended................................4493 177.2550 (a) revised...............................................29668 177.2600 (c)(4)(iii) amended.......................................35910 178.1005 (d) revised...............................................26146 178.1010 (b)(32) and (c)(27) added...................................409 (b)(34) and (c)(29) added......................................29842 (c)(29) corrected..............................................34047 178.2010 (b) table amended; eff. 4-2-87.............................6324 (b) table amended...20070, 22301, 30150, 33930, 35541, 35911, 37446, 43059, 43323 Technical correction...........................................24090 (b) table corrected............................................26764 178.3295 Table amended.............................................30920 178.3910 (a)(4)(i)(a) amended......................................10223 179.22 Petitions for deferral of effective date denied..............5450 179.24 Petitions for deferral of effective date denied..............5450 179.25 Petitions for deferral of effective date denied..............5450 179.26 Petitions for deferral of effective date denied..............5450 182.8245 Removed...................................................25211 184.1245 Added.....................................................25211 184.1259 (a) revised; (b) (8) and (9) revised......................47920 (a)(2) corrected...............................................48905 184.1287 Added.....................................................25976 184.1328 Added.....................................................42430 184.1639 Added.....................................................10886 184.1768 Added.....................................................10886 193.98 Added.......................................................29009 (b) corrected..................................................31846 193.137 Existing text designated as (a); (b) added.................17941 193.142 Heading and text nomenclature change.......................32293 193.253 Table amended..............................................10562 193.277 (d) added..................................................41418 (d) corrected..................................................42760 193.410 Revised....................................................27543 193.430 Heading and text nomenclature change.......................32293 193.472 Added......................................................10563 193.473 Added......................................................17942 Technical correction.............................23137, 23916, 34903 193.475 Added......................................................43324 193.476 Added......................................................39222 201 Authority citation revised......................................2111 201.20 (a) revised; (c) added......................................21509 201.21 Effective date deferred in part.............................12152 201.21 Added; eff. 4-20-87..........................................2111 207 Authority citation revised......................................2682 207.20 (a) amended..................................................2682 207.25 (b) (1) and (6) amended......................................2682 207.35 (b)(2)(iii) amended..........................................2682 310 Authority citation revised..............................30055, 37936 310.201 (a)(6) removed; eff. 5-2-88................................15892 (a)(14) removed; eff. 8-12-88..................................30055 Technical correction...........................................34047 310.305 (b)(4) revised; (c)(1) redesignated as (c)(1)(i); (c)(1)(ii) added...........................................37936 312 Revised; eff. 6-17-87...........................................8831 312.7 Heading and (d) revised; OMB number..........................19476 Technical correction...........................................23628 312.10 OMB number..................................................23031 312.23 OMB number..................................................23031 312.30 OMB number..................................................23031 312.31 OMB number..................................................23031 312.32 OMB number..................................................23031 312.33 OMB number..................................................23031 312.34 Text added..................................................19476 Technical correction...........................................23628 312.35 Added.......................................................19477 Technical correction...........................................23628 312.36 OMB number..................................................23031 312.38 OMB number..................................................23031 312.41 OMB number..................................................23031 312.42 (b)(3) added................................................19477 Technical correction...........................................23628 312.44 OMB number..................................................23031 312.45 OMB number..................................................23031 312.47 OMB number..................................................23031 312.53 OMB number..................................................23031 312.55 OMB number..................................................23031 312.56 OMB number..................................................23031 312.57 OMB number..................................................23031 [[Page 226]] 312.59 OMB number..................................................23031 312.62 OMB number..................................................23031 312.64 OMB number..................................................23031 312.66 OMB number..................................................23031 312.70 OMB number..................................................23031 312.110 OMB number.................................................23031 312.120 OMB number.................................................23031 312.140 OMB number.................................................23031 312.160 OMB number.................................................23031 314.50 (d)(5) (x) and (xi) added; eff. 6-17-87......................8847 314.80 (a), (c) introductory text, (1), and (2)(ii)(b), (d)(2), and (f) (1), (3), and (4) amended; (c)(2)(iii) and (e) revised....................................................37936 331 Petition denied................................................33576 331.30 (b) corrected................................................7830 332.30 (a) corrected................................................7830 333 Added; eff. 12-12-88...........................................47322 333.120 (a)(11) corrected..........................................48792 336 Added; eff. 5-2-88.............................................15892 341 Authority citation revised.....................................30055 Technical correction...........................................34047 341.3 (b) and (c) added; eff. 8-12-88..............................30055 341.14 Added; eff. 8-12-88.........................................30055 341.74 Added; eff. 8-12-88.........................................30055 (c)(2) corrected...............................................35610 341.76 OMB number; eff. 10-2-87.....................................7126 OMB number......................................................7126 (b) corrected...................................................7830 Technical correction...........................................12521 341.90 (b) and (c) added; eff. 8-12-88.............................30057 344.50 (b) corrected................................................7830 357.150 (b) corrected...............................................7831 357.152 OMB number..................................................2515 357.250 (b) corrected...............................................7830 369 Authority citation revised..............................30057, 47324 369.6 Removed; eff. 12-12-88.......................................47324 369.20 Amended; eff. 5-2-88........................................15893 Amended; eff. 8-12-88..........................................30057 Technical correction...........................................34047 Amended; eff. 12-12-88.........................................47324 369.21 Amended; eff. 5-2-88........................................15893 Amended; eff. 8-12-88..........................................30057 Technical correction...........................................34047 Amended; eff. 12-12-88.........................................47324 430.4 (a)(56) added.................................................4611 (a)(57) added..................................................42287 430.5 (a)(89) and (91) added........................................4611 (a)(90) and (b)(92) added......................................42287 (a)(91) and (b)(93) added......................................42431 430.6 (b)(91) added.................................................4611 (b)(92) added..................................................42288 (b)(93) added..................................................42431 436.20 (d)(9) added.................................................4611 436.105 (b) table amended...........................................4617 436.212 (e)(4) added; (f) revised...................................4617 436.215 (b) table amended; (c)(9) added............................42432 Correctly designated...........................................43966 (c)(9)(i) corrected............................................45528 436.217 Added......................................................42432 436.361 Added.......................................................4611 436.361 (c)(4) corrected........................................8550 436.542 (c) amended................................................35912 440.9a (b)(1)(i) revised; (b)(1)(ii)(d) added......................42288 (b)(1)(ii)(d)(4) formula corrected.............................45281 440.209 Redesignated as 440.209a; new 440.209 added................42288 440.209a Redesignated from 440.209.................................42288 440.209b Added.....................................................42288 442.19 Added.......................................................42432 Heading corrected..............................................43966 (b)(1)(i) (A) and (D) and (iv)(A) formula corrected............45528 442.27 (a)(1) amended..............................................35912 442.53a (b)(1)(iv)(a) revised......................................35912 442.55 Added.......................................................44860 442.119 Added......................................................42433 (b)(1)(iii) formula corrected..................................45528 442.127a (a)(1) amended............................................20710 442.255 Redesignated as 442.255a; new 442.255 added................44860 442.255a Redesignated from 442.255.................................44860 442.255b Added.....................................................44860 444.542i Removed...................................................35912 449.150d (a)(3)(i)(a) corrected.....................................7741 455.4a Added........................................................4614 455.82a Added......................................................42290 (b)(1)(iii)(D) and (iv) corrected..............................45281 455.204 Added.......................................................4615 (b)(1) and (b)(1)(ii)(c) corrected..............................8550 500.80--500.92 (Subpart E) Added...................................49586 510 Authority citation revised.....................................25976 510.600 (c)(1) and (2) tables amended..............................5455, 7831, 7833, 11041, 11988, 12153, 18691, 19501, 20385, 20597, 25212, 25976, 27801, 32540, 32917, 36022, 36023, 39912, 41295, 41988 (c) (1) and (2) tables amended; eff. 4-3-87.....................9295 [[Page 227]] Technical correction.............................10668, 18495, 23397 511.1 (c)(2) revised; (b)(4)(vi) and (f) added; eff. 6-17-87........8847 514.1 (b)(8)(viii) and (ix) added; eff. 6-17-87.....................8847 (b)(7) introductory text and (ii) revised; OMB number..........49588 514.111 (a)(10) added..............................................49588 520 Technical correction....................................10668, 18495 Heading corrected..............................................28067 520.23 (a)(2) revised................................................666 520.314 (a) revised................................................11989 520.540a (b) amended................................................7832 520.540b (a)(2) and (b)(2) amended..................................7832 520.580 (b)(1) revised.............................................39512 520.680 Removed....................................................25213 520.680a Removed...................................................25213 520.680b Removed...................................................25213 Correctly designated...........................................27108 520.970a (b) amended................................................7832 520.970b (b) amended................................................7832 520.1044a (b) amended...............................................7832 520.1044b (b) amended...............................................7832 520.1044c (b) amended...............................................7832 (a) revised....................................................48675 520.1100 (c)(1) amended.............................................7832 520.1193 Added.....................................................11042 520.1195 Added.....................................................34637 520.1242a (f)(2)(i) amended........................................20598 520.1341 (b) amended................................................7832 520.1448a (b) removed..............................................27197 (d)(4)(iii) amended............................................30151 520.1540 Removed...................................................20597 520.1660d (e) revised..............................................48094 520.1720a (b)(5) removed...........................................36023 520.2041 Added.....................................................37937 520.2100 (b) amended................................................7832 (b) corrected...................................................9756 520.2455 Revised...................................................15718 520.2473a (b) amended...............................................7832 520.2473b Added....................................................43059 522 Technical correction....................................10668, 18495 522.56 Added.......................................................11816 (a) corrected..................................................15412 522.161 (c) amended.................................................7832 522.163 (b) amended.................................................7832 522.518 (b) amended.................................................7832 522.540 (a)(2) amended..............................................7832 (b)(2)(ii) and (c)(2) amended..................................25212 (e)(2) amended.................................................36023 522.900 (b)(2) amended..............................................7832 522.970 (b) amended.................................................7832 522.1044 (b)(1) amended.............................................7832 522.1060b (b) amended...............................................7832 522.1081 (a)(2)(i) amended.........................................25212 522.1182 (a)(4)(i) amended..........................................7832 522.1183 (e)(1) revised............................................18691 (e)(1) amended.................................................36023 522.1258 (b) amended...............................................25212 522.1660 (c)(1)(i) and (ii) amended................................19502 522.1662a (e)(1) amended............................................7834 (i)(2) amended.................................................36023 522.1680 (b) revised...............................................18691 (b) amended.............................................25212, 36023 522.1704 (b)(2) amended............................................25212 522.1720 (b)(2) amended.....................................25212, 36023 522.1820 (b) amended................................................7832 522.1822 (b) amended................................................7832 522.1881 Added.....................................................23032 522.1884 (c) amended...............................................25212 522.1890 (b)(2) amended.............................................7832 522.1940 (d)(2)(iii) amended; (e) added............................45312 522.2063 (b) amended................................................7832 522.2100 (a)(2) and (b)(2) amended..................................7832 522.2476 Added.....................................................24995 522.2483 (b) amended................................................1903 524 Technical correction....................................10668, 18495 524.1044a (b) amended...............................................7832 524.1044b (b) amended...............................................7832 524.1044c (b) amended...............................................7832 524.1044d (b) amended...............................................7832 524.1044e (b) amended...............................................7832 524.1044f (b) amended...............................................7833 524.1240 Added.....................................................10887 524.1580b (b) amended..............................................18691 524.1580d (b) and (d)(1)(i) revised.................................4897 (b) revised....................................................18691 (b)amended.....................................................36023 524.2350 (b) amended................................................7833 529.1044a (b) amended...............................................7833 Technical correction....................................10668, 18495 529.1044b (b) amended...............................................7833 Technical correction....................................10668, 18495 540.274b (c)(3)(ii) amended; (c)(5) added..........................32917 540.874a (c)(3)(i) and (4)(i) amended..............................36023 544.110 Removed....................................................22438 546.180h (a)(1) and (c)(4)(i) amended..............................43060 546.180i (a)(1) and (c)(4)(i) amended..............................43061 556.170 Revised....................................................43061 556.210 Removed....................................................25213 556.420 (b) revised................................................15718 556.500 (d) revised................................................24293 [[Page 228]] 556.710 Revised....................................................27683 556.739 Added......................................................24995 558.3 (b)(3) amended................................................2682 558.4 (d) table revised.............................................2682 (d) table amended...............................................4284 (d) correctly designated........................................4992 (d) table corrected.............................................7834 (d) table amended................................25213, 26956, 39912 558.5 Heading revised; (a), (b), and (c) introductory text and (2) amended.....................................................2684 558.45 Removed.....................................................39912 558.55 (d)(1)(i)(b), (2) introductory text and table and (3) introductory text amended...................................2684 (d)(1)(ii)(b) corrected.........................................6649 558.58 (a)(2) amended...............................................2684 558.76 (a) amended..................................................2684 558.78 (d)(1) table amended.........................................2684 (d)(3)(xi) added................................................2687 558.120 (c)(1)(iii) added...........................................2687 558.128 (c)(3) Tables 1 and 2 headings revised......................2684 558.145 (d)(1) amended..............................................2684 558.155 (d)(3) table heading revised................................2684 558.175 (c) introductory text, (1) (ii) and (iii), and (4)(ii) amended.....................................................2684 558.185 (d) introductory text, (1)(i)(b), (2)(iii), and (3)(iii) amended.....................................................2684 558.195 (c) revised; (b) (1) and (2) tables combined and amended; (d)(2) introductory text removed; (d)(1) redesignated as (d) and introductory text revised...........................2684 (c) corrected...................................................4992 (d) table amended................................38924, 43061, 43062 558.205 (b)(3) amended; (b)(4) removed..............................2684 558.240 (c) introductory text amended...............................2684 Removed........................................................25213 558.248 (a)(2) revised; (a) (3), (4), and (5) added; (b) amended 2684 558.274 (c)(1) introductory text amended............................2684 (a)(4), (c)(1)(i) and (ii) amended; eff. 4-3-87.................9295 (c)(1) table amended; (a)(7) revised...........................29010 558.311 (a) through (d) redesignated as (b) through (e); new (a) added; new (e) table amended; new (b), (d), and (e) introductory text revised...................................2685 (d)(5) (i) and (ii) and (e) table amended......................16240 (b) revised; (e) introductory text and (1) through (11) redesignated as (e)(1) introductory text and (i) through (xi); (e)(2) added.......................................................24996 (b)(5) added; (e)(1) table amended.............................26299 (b)(3) amended; (e)(1) table amended...........................33804 (e)(2)(ii) correctly revised...................................33930 Technical correction...........................................35518 (b)(3) and (e)(1) table amended................................41988 (e)(1) table amended...........................................48095 558.325 (c)(1) introductory text and (2) introductory text revised; (c)(3) (i) and (ix) amended........................2685 (a)(1)(iv) added...............................................28470 558.342 (a), (c) introductory text, (1)(ii) and (2)(ii) amended.....2685 (c)(3) added...................................................33804 Technical correction...........................................35518 558.355 (a) added; (b)(3), (c), (d) (1), (2), (5), (7), and (9), and (f)(1) (ii), (iv), (vi), (vii), (x) introductory text and (b), (xi) introductory text and (b), (xvii), (3)(i)(b)(1) and (2), and (iv)(b) amended...................2685 (f)(1)(xiii)(b) and (xxi)(b) revised...........................13641 (b)(4) and (f)(2) added........................................15718 (b)(13) and (f)(3)(v) added....................................27197 558.360 (d)(3) amended.............................................11642 558.365 (d)(1)(ii) amended..........................................2685 558.369 (d) introductory text amended...............................2686 558.370 (b) introductory text amended...............................2686 558.376 (c) introductory text, (1)(ii) and (2)(ii) amended..........2686 558.415 (a) revised................................................36402 558.430 (c) introductory text amended...............................2686 558.435 (c) revised.................................................2686 558.450 (b) and (d)(1) table 1 heading amended......................2686 (d)(1) Table 3 amended.........................................24293 (d)(1) Table 3 corrected.......................................26401 (d)(2)(ii) added...............................................48096 [[Page 229]] 558.460 (c)(1) introductory text amended............................2686 558.464 (b)(2) amended..............................................2686 558.465 Heading revised; (b) (1), (2), (3), and (4) amended.........2686 558.485 (a)(26) revised..............................................781 (e)(1)(ii), (2)(ii), (3)(ii), (4)(ii), (10)(ii) and (11)(ii) amended.............................................................2686 558.515 (b) and (d)(1)(ii) amended..................................2686 558.525 (b)(1), (2) (i) and (ii), (d)(1)(ii), (2)(ii), (3)(ii), (4)(ii) and (5)(ii) amended.................................2686 (a)(1) removed.................................................12521 558.526 Heading revised; (a), (d) (1) and (2) amended; (b) removed 2686 Removed........................................................12521 558.530 (d)(1)(iii) and (2)(i)(b) amended...........................2686 558.550 (b)(2) removed..............................................1626 Correctly designated............................................7261 558.575 (a) revised; (c)(1)(ii) amended.............................2686 558.579 (c)(1)(iii) amended.........................................2686 558.586 (e)(2) removed; (f) amended.................................2686 558.600 Added......................................................26956 558.615 (a), (b), and (d)(5)(iii) amended...........................2686 558.625 (b)(42) revised..............................................530 (b)(81) removed.................................................7833 (b)(18) removed; eff. 4-3-87....................................9295 (b) (37) and (64) removed......................................11041 (b)(7) removed.................................................11988 (b)(70) removed................................................12153 (b)(89) added..................................................27801 558.630 (b)(10) amended.............................................1626 (b)(10) amended................................................28470 558.635 (e)(2), (f)(1) introductory text and (2) introductory text amended.....................................................2686 558.680 (c)(1) introductory text revised; (c)(1) table amended......2686 561.96 Added.......................................................29009 561.99 Revised.....................................................27545 561.273 (a) table amended..........................................12154 (d) added......................................................41418 561.360 Revised....................................................27543 561.400 Heading and text nomenclature change.......................32293 561.415 Heading and text nomenclature change.......................32293 561.425 Heading and text nomenclature change.......................32293 561.430 Table amended...............................................1447 Table amended..................................................27544 561.439 Added......................................................10563 561.440 Added......................................................17941 561.441 Added......................................................17942 Technical correction.............................23137, 23916, 34903 561.442 Added......................................................39222 571.1 (c) amended...................................................8583 571.115 Added......................................................49588 573 Authority citation revised.....................................10888 573.920 Revised....................................................10888 (c)(1) corrected...............................................21001 610 Authority citation revised.....................................37450 610.53 (c) table amended...........................................37450 660.30-660.36 (Subpart D) Revised; eff. in part 10-7-88............37450 660.102 Introductory text amended..................................39637 660.103 (f)(1) revised.............................................39637 660.105 (a)(1) revised.............................................39637 680.3 (e) and (f) added; OMB number................................37607 680.4 Removed......................................................37607 805 Added..........................................................27763 862 Added..........................................................16122 862.1385 (a) corrected.............................................29468 862.3750 (b) corrected.............................................48623 864 Authority citation revised; section authority citations removed....................................................17732 864.1 Revised......................................................17732 864.3 Added........................................................17732 864.5220 (c) added.................................................17733 864.5680 (c) added.................................................17733 864.7250 (c) added.................................................17733 864.7300 (c) added.................................................17733 864.9205 (c) added.................................................17733 864.9245 (c) added.................................................17733 866 Authority citation revised; section authority citations removed....................................................17733 866.1 Revised......................................................17733 866.3 Added........................................................17733 (b) and (c) corrected..........................................22577 866.2420 (c) added.................................................17734 866.3290 (c) added.................................................17734 866.3305 (c) added.................................................17734 866.3510 (c) added.................................................17734 866.6010 (c) added.................................................17734 868 Authority citation revised; section authority citations removed....................................................17734 868.1 Revised......................................................17734 868.3 Added........................................................17734 868.1120 (c) added.................................................17735 (c) corrected..................................................22577 [[Page 230]] 868.1150 (c) added.................................................17735 868.1170 (c) added.................................................17735 868.1200 (c) added.................................................17735 868.2450 (c) added.................................................17735 868.2500 (c) added.................................................17735 868.5400 (c) added.................................................17735 868.5610 (c) added.................................................17735 870 Authority citation revised; section authority citations removed....................................................17735 870.1 Revised......................................................17735 870.3 Added........................................................17735 870.1025 (c) added.................................................17736 870.1350 (c) added.................................................17736 870.1360 (c) added.................................................17736 870.3300 (c) added.................................................17736 870.3375 (c) added.................................................17736 870.3450 (c) added.................................................17736 870.3535 (c) added.................................................17736 870.3545 (c) added.................................................17736 870.3600 (c) added.................................................17736 870.3610 (c) added.................................................17736 870.3620 (c) added.................................................17736 870.3680 (c) added.................................................17736 870.3700 (c) added.................................................17736 870.3710 (c) added.................................................17736 870.3800 (c) added.................................................17736 870.3850 (c) added.................................................17736 870.3925 (c) added.................................................17737 (c) revised; eff. 12-9-87......................................18163 (c) corrected..................................................23137 870.4230 (c) added.................................................17737 870.4260 (c) added.................................................17737 870.4320 (c) added.................................................17737 870.4350 (c) added.................................................17737 870.4360 (c) added.................................................17737 870.5200 (c) added.................................................17737 870.5225 (c) added.................................................17737 870.5300 (c) added.................................................17737 870.5550 (c) added.................................................17737 872 Added..........................................................30097 872.3680 (a) corrected.............................................34456 872.6080 (a), (b), and (c) corrected...............................49250 874.9 Added........................................................32111 874.1100 Correctly designated......................................18495 (b) revised....................................................32111 874.3540 (b) revised...............................................32111 874.4420 (b) revised...............................................32111 874.5800 (b) revised...............................................32111 876 Authority citation revised; section authority citations removed....................................................17737 876.1 Revised......................................................17737 (d) corrected..................................................22577 876.3 Added........................................................17737 876.3350 (c) added.................................................17738 876.3630 (c) added.................................................17738 876.3750 (c) added.................................................17738 876.4480 (c) added.................................................17738 876.5220 (c) added.................................................17738 876.5270 (c) added.................................................17738 876.5280 (c) added.................................................17738 876.5540 (c) added.................................................17738 876.5860 (c) added.................................................17738 876.5870 (c) added.................................................17738 876.5955 (c) added.................................................17738 880 Authority citation revised; section authority citations removed....................................................17738 880.1 Revised......................................................17738 880.3 Added........................................................17738 880.5130 (c) added.................................................17739 880.5760 (c) added.................................................17739 882 Authority citation revised; section authority citations removed....................................................17739 882.1 Revised......................................................17739 882.3 Added........................................................17739 882.1790 (c) added.................................................17739 882.1825 (c) added.................................................17740 882.5150 (c) added.................................................17740 882.5800 (c) added.................................................17740 882.5840 (c) added.................................................17740 882.5850 (c) added.................................................17740 882.5860 (c) added.................................................17740 882.5940 (c) added.................................................17740 882.5950 (c) added.................................................17740 884 Authority citation revised; section authority citations removed....................................................17740 884.1 Revised......................................................17740 884.3 Added........................................................17740 884.1060 (c) added.................................................17741 884.1100 (c) added.................................................17741 884.1185 (c) added.................................................17741 884.2050 (c) added.................................................17741 884.2620 (c) added.................................................17741 884.2685 (c) added.................................................17741 884.4100 (c) added.................................................17741 884.4150 (c) added.................................................17741 884.4250 (c) added.................................................17741 884.4270 (c) added.................................................17741 884.5050 (c) added.................................................17741 884.5225 (c) added.................................................17741 884.5380 (c) added.................................................17741 (c) revised....................................................36883 Technical correction...........................................38171 884.5940 (c) added.................................................17741 886 Added..........................................................33355 888 Added..........................................................33702 Technical correction...........................................36863 [[Page 231]] 890 Authority citation revised; section authority citations removed....................................................17741 890.1 Revised......................................................17741 890.3 Added........................................................17741 890.3610 (c) added.................................................17742 890.3890 (c) added.................................................17742 (c) corrected..................................................22577 890.5275 (c) added.................................................17742 890.5290 (c) added.................................................17742 890.5300 (c) added.................................................17742 890.5525 (c) added.................................................17742 890.5860 (c) added.................................................17742 1240 Authority citation revised....................................29514 1240.61 Added......................................................29514 Chapter II 1301.11 (c) and (d) revised........................................20598 1301.12 Revised....................................................20599 1301.22 (a)(10) revised............................................17287 1301.31 (c) revised; (d) added.....................................20599 1306.22 (a) revised...........................................1904, 3605 Technical correction...........................................13430 1308.11 (g) (1) and (2) removed; (b) (33) through (47) and (g) (3) through (11) redesignated as (b) (34) through (37) and (b) (39) through (49) and (g) (1) through (9); (b) (33) and (38) added..................................................2516 (b)(2) removed; (b) (3) through (49) redesignated as (b) (2) through (48)........................................................2517 (g) designations corrected......................................6546 (g) temporary placement extended................................7270 (b) introductory text revised; (b) (1) through (48) redesignated as (b) (2) through (7), (9) and (10), (12) through (33), (35) through (40), (42) through (51), (53) and (54); new (b) (1), (8), (11), (34), (41), and (52) added; (g) (1), (2), (4), (6), (8), and (9) removed; (g) (3), (5), and (7) redesignated as (g) (1), (2), and (3)..............................................20072 Technical correction...........................................27198 (g) (4) through (6) added......................................38226 1308.12 (c) (1) through (23) redesignated as (c) (2) through (24); new (c)(1) added............................................2517 (f)(2) added...................................................11043 (f)(2) corrected...............................................12285 1308.13 (c)(12) added...............................................2222 (c)(1)(i), (ii), and (iii) and (2)(i), (ii), and (iii) revised 5952 1308.14 (b)(1) and (2) revised......................................5952 1308.15 (c)(6) revised..............................................5952 1308.24 (i) table revised; interim..................................9807 1308.31--1308.32 Undesignated center heading revised; interim.......9803 1308.31 Heading, (a), (b) introductory text, and (d) revised; (c) amended; interim............................................9803 1308.32 Revised; interim............................................9803 1311.02 (d) revised................................................17288 1311.21 Revised....................................................17288 1311.26 Revised....................................................17288 1311.32 (d) revised; (e) and (f) redesignated as (f) and (g); new (e) added..................................................17288 1311.42 (a), (b)(6) (i) and (iv) revised...........................17288 1311.44 (a) and (b) revised; (c) through (e) redesignated as (e) through (g); new (c) and (d) added; new (f) (1) and (2) and (g) (1) and (2) revised................................17288 1311.47 Revised....................................................17289 1311.53 Revised....................................................17289 1311.61 Revised....................................................17289 1312 Authority citation revised....................................17289 1312.11 (a) and (b) revised........................................17289 1312.12 (a) introductory text revised..............................17289 1312.13 (a)(1) revised; (b) through (e) redesignated as (d) through (g); new (b) and (c) added.........................17289 1312.18 (a), (b), and (c)(2) revised...............................17290 1312.21 (a) and (b) revised........................................17290 1312.22 (a) revised................................................17290 1312.23 (b) through (d) redesignated as (d) through (f); new (b) and (c) added .......... 17290 1312.27 (a), (b) (2) and (4) revised; (b)(5) added.................17290 1312.28 (d) revised................................................17291 1312.30 Added......................................................17291 1316.71-1316.81 (Subpart E) Authority citation revised.............24446 1316.74 Amended................................................41418 1316.75 (b)(3) amended.............................................24446 [[Page 232]] 1988 21 CFR 53 FR Page Chapter I Chapter I Uniform compliance date 1-1-91...........................44861 1 Authority citation revised; section authority citations removed 2828 1.4 Added...........................................................2828 5 Authority citation revised.......................................26049 5.10 (a)(29) added.................................................26049 5.24 Added.........................................................26049 5.35 (a)(1) revised................................................22293 5.83 (c) redesignated as (d); new (c) added.........................2225 (d)(1) and (2) revised; (d)(3) added...........................17186 (b)(1) and (c)(1) revised......................................40055 5.93 Revised.......................................................18274 5.100 Revised.......................................................8617 5.115 Revised.......................................................8618 12 Authority citation revised......................................29453 Authority citation corrected...................................34871 12.125 (a), (c), and (d) revised...................................29453 14.80 (a)(2) and (b)(1)(ii) revised................................50949 14.95 (a) revised..................................................50949 14.100 (c) added...................................................49550 (d)(1)(iv) amended.............................................50950 16 Authority citation revised.......................................4615 16.26 Added.........................................................4615 60 Added............................................................7305 73 Technical correction............................................49823 73.3107 Added......................................................41324 73.3110a Added.....................................................41325 74.706 (d)(2) suspended............................................49138 74.1267 Removed....................................................26770 Clarification..................................................29655 74.1308 Removed....................................................26768 Clarification..................................................29655 74.1309 Removed....................................................26768 Clarification..................................................29655 74.1319 Removed....................................................26770 Clarification..................................................29655 74.1333 Added......................................................33120 Technical correction...........................................41649 Addition confirmed.............................................43682 74.1336 Added......................................................29031 (b) corrected..................................................35255 (c) addition deferred in part..................................43683 (c) deferral at 53 FR 43683 removed; (c) amended...............52130 74.1706 (c)(2) suspended...........................................49138 74.2267 Removed....................................................26770 Clarification..................................................29655 74.2308 Removed....................................................26768 Clarification..................................................29655 74.2309 Removed....................................................26768 Clarification..................................................29655 74.2319 Removed....................................................26770 Clarification..................................................29655 74.2333 Added......................................................33120 Technical correction...........................................41649 74.2336 Added......................................................29031 Addition confirmed.............................................43683 81.1 (a) and (b) tables amended.............................15551, 25127 (b) table amended......................20, 6984, 29031, 33121, 33122 Technical correction...........................................41649 (b) table amendment at 53 FR 33121 confirmed...................43682 (b) table amendment at 53 FR 29031 deferred; (b) table amended 43683 (a) table amended.......................................43687, 52131 (b) deferral at 53 FR 43683 removed............................52130 81.25 (a)(1) table, (b)(1)(i), and (c)(1) table amended............29031 Removed........................................................33121 Technical correction...........................................41649 Removal deferred in part.......................................43682 (c)(1) table amendment deferred in part.................43682, 43683 (c)(1) deferral at 53 FR 43683 removed.........................52130 81.27 (d) introductory text table amended......................20, 6984, 15551, 25127, 29031, 33121, 33122, 43687, 52131 Technical correction...........................................41649 (d) introductory text table amendment at 53 FR 33121 confirmed 43682 81.30 (s)(3) and (4) added.........................................26768 (r)(4) and (5) and (t)(3) and (4) added........................26770 Clarification..................................................29655 82.1267 Removed....................................................26770 Clarification..................................................29655 82.1308 Removed....................................................26768 Clarification..................................................29655 82.1309 Removed....................................................26768 Clarification..................................................29655 82.1319 Removed....................................................26770 Clarification..................................................29655 82.1333 Revised....................................................33121 Technical correction...........................................41649 Revision confirmed.............................................43682 82.1336 Revised....................................................29031 Revision confirmed.............................................43683 101.2 (d)(2) introductory text revised.............................16068 [[Page 233]] 133.155 Revised.....................................................3743 133.155 Effective date confirmed...................................37752 133.156 Revised.....................................................3743 133.156 Effective date confirmed...................................37752 170 Authority citation revised.....................................16546 170.3 (f) revised..................................................16546 170.30 (c) redesignated as (c)(1); new (c)(1) amended; (c)(2) added......................................................16546 170.35 (c)(1) introductory text revised; OMB number................16547 172.133 Added......................................................41329 Technical correction...........................................49638 172.800 Added......................................................28382 172.804 (c) (8), (9), (10), and (11) request for stay denied and effective date confirmed....................................6595 (c)(13) added..................................................20838 (c)(12) added..................................................20839 (c)(14) added..................................................20840 (c)(15) added..................................................20841 (c) (16) and (17) added........................................20842 Technical correction...........................................23340 (c)(18) added..................................................40879 (b) revised....................................................51273 172.811 Added......................................................21632 172.859 (c)(3) revised.............................................22294 (a) amendment and (b) (10) and (11) additions in 51 FR 40161 republished........................................................22297 Technical correction....................................26559, 36785 173 Authority citation revised..............................15199, 39456 173.73 Added.......................................................39456 (a)(2) corrected........................................43319, 49823 173.310 (c) table amended..........................................15199 (c) table corrected............................................18194 175.105 (c)(5) table amended.........................29454, 32606, 52131 175.300 (b)(3)(xxxiii) amended.....................................34279 176.170 (a)(5) table corrected........................................97 (a)(5) table amended................8620, 28636, 34045, 50211, 50952 177.1310 (b) revised...............................................44009 177.1330 (c) amended...............................................44009 177.1390 (c)(3)(i)(a) (1) and (2) and (b) (1) and (2) amended; (c)(2)(vi) and (3)(i)(b)(3) added..........................39084 177.1395 (b)(4) table amended......................................19773 177.1500 (a)(14) added; (b) table amended; (c)(5) redesignated as (c)(5)(i); (c)(5)(ii) added................................19773 177.1580 (b) table amended.........................................29656 177.1990 (c)(3) and (e) revised....................................47185 177.2550 (a) revised...............................................31835 (a)(3) added...................................................32215 Technical correction...........................................36391 177.2910 Introductory text revised; (a) redesignated as (a)(1) and revised; new (a)(2) added..................................17925 178.1005 (e)(1) revised............................................47186 178.1010 (b)(35) and (c)(30) added.................................31837 178.2010 (b) table amended.....15200, 18087, 29657, 32375, 47526, 49551, 52133 178.3295 Table amended.............................................30049 Technical correction...........................................18194 178.3297 (e) table amended.........................................52132 178.3570 (a)(3) table amended................................8441, 44397 179.26 (c)(4) amended..............................................12757 Effective date corrected.......................................16615 (b) table amended..............................................53209 182 Authority citation revised.....................................16864 182.1 (a) amended..................................................44875 182.90 Amended..............................................16864, 44876 182.8301 Removed...................................................16864 182.8304 Removed...................................................16864 182.8306 Removed...................................................16864 182.8308 Removed...................................................16864 182.8311 Removed...................................................16864 182.8315 Removed...................................................16864 182.8375 Removed...................................................16864 184.1259 Technical correction.......................................4384 184.1296 Added.....................................................16864 184.1297 Added.....................................................16864 184.1298 Added.....................................................16865 184.1301 Added.....................................................16865 184.1304 Added.....................................................16865 (a) and (d) corrected..........................................20939 184.1307 Added.....................................................16865 184.1307a Added....................................................16865 184.1307b Added....................................................16865 184.1307c Added....................................................16866 184.1307d Added....................................................16866 184.1308 Added.....................................................16866 (b) corrected..................................................20939 184.1311 Added.....................................................16866 184.1315 Added.....................................................16866 184.1375 Added.....................................................16867 184.1538 Added.....................................................11250 Technical correction...........................................16837 184.1555 (c)(1) amended............................................52682 184.1854 Added.....................................................44876 184.1857 Added.....................................................44876 184.1859 Added.....................................................44876 184.1865 Added.....................................................44876 186.1300 Added.....................................................16867 [[Page 234]] (b)(2) corrected...............................................20939 184.1330 (c) table amended..........................................5766 186.1374 Added.....................................................16867 (b)(2) corrected...............................................20939 193 Redesignated as 40 CFR Part 185................................24666 Correctly redesignated as 40 CFR Part 185......................26131 193.15 (b) removed..................................................8874 193.70 Removed......................................................9434 193.84 Removed......................................................8874 193.85 (c) removed..................................................9434 193.87 Removed......................................................8874 193.98 (a) added....................................................1917 (c) added......................................................18837 193.100 Revised.....................................................9434 193.137 (b) amended................................................20308 193.142 Introductory text revised..................................23389 193.145 Removed.....................................................9434 193.152 (c) removed.................................................8874 193.156 (b), (c) and (d) removed....................................8874 193.186 (a) table amended...........................................5367 193.215 Removed.....................................................9434 193.219 Removed.....................................................9434 193.235 (b) removed.................................................9434 193.277 (c) removed.................................................8874 193.284 Removed.....................................................9434 193.301 Removed.....................................................9434 193.400 Revised.....................................................9434 193.415 Removed.....................................................9434 193.430 Revised....................................................23389 193.468 Revised.....................................................8874 193.469 Removed.....................................................8874 193.473 Amended....................................................23107 193.477 Added..................................................21, 12943 193.479 Added........................................................234 Amended........................................................23388 193.480 Added; eff. to 6-30-89.....................................23386 193.481 Added......................................................23387 201 Authority citation revised......................................4135 201.20 (c) suspended...............................................49138 201.21 OMB number...................................................4135 201.314 (h)(1) amended; (h)(5) removed.............................21637 (h)(1) corrected...............................................24830 299 Authority citation revised......................................5369 299.4 (e) revised...................................................5369 310.540 Added......................................................31271 312.23 (e) added....................................................1918 312.30 (d) introductory text amended................................1918 312.31 (b) introductory text amended................................1918 312.80--312.88 (Subpart E) Added; interim..........................41523 Technical correction...........................................44144 312.110--312.145 (Subpart E) Redesignated as Subpart F; interim....41523 (Subpart F) Redesignated from Subpart E; interim...............41523 312.160 (Subpart F) Redesignated as Subpart G; interim.............41523 (Subpart G) Redesignated from Subpart F; interim...............41523 314.125 (c) added; interim.........................................41524 Technical correction...........................................44144 314.420 (c) amended................................................33122 333.110 (e) redesignated as (f); new (e) added.....................18838 333.120 (a)(10) revised............................................18838 336.50 (d) (1), (2), (3), and (4) revised..........................35809 340 Added; eff. 3-1-89..............................................6105 Authority citation corrected...................................11731 341.74 (d)(1) (i), (ii), and (iii) revised.........................35809 341.76 (d)(1), (2)(i)(a), and (ii) revised.........................35810 349 Added...........................................................7090 Addition effective date corrected to 3-6-89....................13217 357 Authority citation revised.....................................35810 357.150 (d)(1) revised.............................................35810 369.20 Amended......................................................7093 Amendment effective date corrected to 3-6-89...................13217 430.4 (a)(58) added................................................13400 (a)(59) added..................................................24257 (a)(59) corrected..............................................26712 430.5 (a)(92) and (b)(94) added....................................13400 (a) (93) and (95) added........................................24257 430.6 (b)(94) added................................................13401 (b)(95) added..................................................24257 436.20 (d)(10) added...............................................13401 436.31 (b)(16) added...............................................13401 436.32 (j) added...................................................13401 436.106 (a) table and (b) table amended............................32607 Correctly designated...........................................39839 436.215 (b) table amended; (c)(10) added...........................24257 (c)(10) correctly designated; (c)(10)(iii) corrected...........26712 436.362 Added.......................................................1919 436.363 Added......................................................13401 (c)(3) corrected...............................................19368 436.364 Added......................................................13401 442.15 Added.......................................................24257 (a)(3)(i) and (b)(1) introductory text corrected...............26712 [[Page 235]] 442.22a Added......................................................13402 (b)(4)(i) corrected............................................19368 442.115 Added......................................................24259 442.115a Added.....................................................24259 442.115b Added.....................................................24259 442.222 Added......................................................13403 (b)(1)(iv)(A) corrected........................................19369 444 Correctly designated...........................................16615 444.42a (a)(2) removed; (a) (3) and (4) redesignated as (a) (2) and (3) and revised; (b)(1)(i)(d) and (ii) revised; (b)(1)(ii) undesignated text removed.......................12660 444.320c Added.....................................................40725 444.542b Heading, (a)(1) introductory text, and (2) revised........18838 444.942a Heading, (a)(1) introductory text, (3) and (4)(i) revised 12658 (a)(3) correctly revised................................12658, 31837 Technical correction...........................................36391 446.60 (a)(1)(i) and (v), (3)(i) and (b) (1) and (5) revised; (a)(1) (viii) and (ix) and (b) (8) and (9) added...........32607 (b)(1) introductory text and (i)(b) heading corrected..........39839 446.160a (a)(3)(i)(a) and (b)(1) revised...........................32609 446.160b (a)(3)(i)(a) and (b)(1) revised...........................32609 446.160c (a)(3)(i)(a) and (b)(1) revised...........................32609 446.260 (a)(3)(i)(a) and (b)(1) revised............................32609 450.24 (a)(1) (iii) through (vi) and (b) (3) through (6) redesignated as (a)(1) (iv) through (vii) and (b) (4) through (7); new (a)(1)(iii) and (b)(3) added; (a)(3)(i) revised....................................................37292 450.224 Redesignated as 450.224a; new 450.224 added................37292 450.224a Redesignated from 450.224.................................37292 450.224b Added.....................................................37292 452.15 (a)(1)(ii) and (b)(2) added; (a)(3)(i) and (b) (4) and (6) revised.....................................................1920 452.510e Added.....................................................12415 (a)(1) and (b) corrected.......................................16837 510 Technical correction...........................................49823 510.600 (c) (1) and (2) tables amended............................11493, 20843, 21993, 22297, 25151, 32610, 39256, 40056, 40057, 40727, 40728, 40729, 50514, 52682 Effective date corrected.......................................39839 (c)(1) table corrected.........................................49823 520 Technical correction...........................................49823 Heading corrected..............................................53120 520.23 (a)(2) amended..............................................40727 520.62 (b) amended.................................................27851 520.110 (a) revised................................................37753 520.246 (b) amended................................................27851 520.314 (b) amended................................................27851 520.315 Added......................................................27344 520.580 (b)(2) amended......................................21993, 40727 520.622a (a)(1) amended............................................40056 (a)(6) amended.................................................40727 520.622b (c)(2) amended............................................40727 520.622c (b)(1) amended............................................40056 (b)(6) amended.................................................40727 520.623 (a) revised................................................45759 520.763a (c) amended...............................................40727 520.763b (c) amended...............................................40727 520.763c (b) amended...............................................40727 520.903d (c)(2)(i) revised.........................................48533 520.905a (d)(2) (ii) and (iii) redesignated as (d)(2)(i) (A) and (B); new (d)(2)(i)(A) revised; new (d)(2)(ii) added........40058 520.1010a (b) amended..............................................40727 520.1192 (c)(1) (ii) and (iii) amended.............................51273 520.1194 Added.....................................................27958 520.1195 (c) (2) and (3) amended...................................51273 520.1204 Heading revised; (b) amended..............................27851 520.1242g Added....................................................23757 520.1330 (c) amended...............................................23390 520.1331 (b) amended...............................................23390 520.1408 (b) amended...............................................40727 520.1801b Removed..................................................48634 520.1900 (b) amended...............................................40727 520.2260b (f)(1) amended...........................................40727 520.2481 (b) amended...............................................40727 520.2611 (b) and (c)(1) revised....................................11063 522 Heading correctly revised......................................26559 Technical correction...........................................49823 522.23 (c) introductory text amended...............................40727 522.46 (b) amended.................................................40057 522.56 (b) amended.................................................27851 522.62 (c) amended.................................................27851 522.246 (b) amended................................................27851 522.311 Added......................................................40057 522.313 Added.......................................................5369 [[Page 236]] 522.480 (a), (b), (c) and (d) heading and (1) through (3) redesignated as (a) (1), (2), (3) and (4) heading and (i) through (iii); new (a)(4)(i) amended; new (b) and (c) added......................................................45760 522.844 Removed....................................................15812 522.1010 (b) amended...............................................40727 522.1044 (b)(3) amended............................................40727 522.1145 (c) added.................................................19773 (d) added......................................................22297 522.1182 (b)(2)(i) amended.........................................40727 522.1183 (e)(1) amended.....................................40728, 40729 522.1192 (a)(3) added; (d)(4)(i) revised...........................11064 (d)(4)(ii) revised.............................................27006 522.1204 (b) amended...............................................27851 522.1222a (c)(2) amended...........................................23390 (c)(1) amended.................................................27851 522.1222b (c) amended..............................................27851 522.1410 (b) amended...............................................40728 522.1662a (k) added................................................11494 (h)(2) amended.................................................40728 522.1680 (b) revised...............................................32610 Effective date corrected.......................................39839 (b) amended....................................................40728 522.2220 (c)(2) amended............................................40728 522.2424 (b) amended........................................23390, 40728 522.2483 (b) amended...............................................40728 522.2640a (b)(2) amended...........................................40728 522.2662 (b) revised.........................................4848, 23608 (b) amended....................................................40728 522.2680 (c) amended...............................................20843 Correctly designated; heading correctly revised................23340 524 Authority citation revised.........................4615, 7504, 12512 Technical correction...........................................49823 524.1200a (b) amended..............................................27851 524.1200b (b) amended..............................................27851 524.1204 (b) amended................................................7504 (a)(2) revised.................................................12512 Technical correction...........................................13217 (b) amended....................................................27851 524.1443 Heading and (a) revised; (c)(2) amended...................26242 524.1465 Added.....................................................39085 524.1484h Removed...................................................4615 524.1484j Removed..................................................11065 524.1580b (b) amended.......................................32610, 40728 Effective date corrected.......................................39839 524.1580c (b) amended..............................................40728 524.1580d (b) revised..............................................32610 Effective date corrected.......................................39839 (b) amended....................................................40728 524.1600a (b) amended..............................................39257 526 Authority citation revised.....................................27851 526.363 (b) amended................................................27851 529.50 (b) amended.................................................27852 529.365 (b) amended................................................27852 540.103g (a)(1) amended..............................................235 540.119 (c)(2) amended.............................................27852 540.129a (c)(2) amended............................................27852 540.129c (c)(2) amended............................................27852 540.181b (c)(2) amended............................................40729 540.203 (c)(2) (i), (iii), (iv) heading and (b) revised; (c)(2)(iv)(c) amended......................................40059 540.207b (c)(2) amended............................................27852 540.255c (a)(2) (i) and (ii) amended...............................27852 540.274b (c)(3)(ii) amended........................................11493 540.814 (c)(2)(i) amended..........................................27852 540.829 (c)(2) amended.............................................27852 544.170b (c)(2) text added.........................................52683 546 Technical correction...........................................49823 546.110e Removed.....................................................235 546.180d (c)(6)(i)(c)(3), (iii)(d)(3) and (iv)(c)(3) amended.......40728 548.114 (c)(2) amended.............................................20843 555 Technical correction...........................................49823 555.110a (c)(1)(ii) amended.................................23390, 40728 555.111 (c)(2) amended.............................................23390 555.310c (c)(2) amended............................................23390 556.113 Added.......................................................5370 556.344 (c) added..................................................27958 556.420 (b) revised................................................40060 558.4 (d) table amended..............................14788, 25152, 40060 Technical correction...........................................18022 558.15 (g)(1) table and (2) table amended..........................20843 558.58 (d)(1) table amended........................................20843 558.76 (d)(3)(xi) added.............................................1018 (a) amended.....................................................4010 (d)(3)(xii) added..............................................11065 Technical correction...........................................14888 558.78 (a)(2) and (d)(1) table and (d)(ii) amended.................20843 558.105 (d)(1)(xi)(b) amended......................................20843 558.120 (c)(1)(iii)(b) amended.....................................20843 558.128 (a) revised; (c)(4) redesignated as (c)(5); new (c)(4) added......................................................31316 558.175 (c)(1)(iii)(b) and (iv)(b) amended.........................20843 558.195 (d) table amended...................................20843, 22298 558.258 (c) introductory text and (1) through (3) redesignated as (c)(1) introductory text and (i) through (iii); new (c)(2) added......................................................14788 [[Page 237]] Technical correction...........................................18022 (c)(1) revised.................................................48533 558.265 (c)(5) added................................................1018 (c)(6) added...................................................11065 Technical correction...........................................14888 558.311 Technical correction.......................................11251 (e)(1) table amended....................................20843, 38708 558.342 (c)(3)(ii) revised.........................................27959 558.355 (f)(3)(ii) introductory text and (b) revised.................236 (b)(9), (f)(1)(iv)(b), (v)(b), (xv)(b) and (xvi)(b) amended....20843 (b)(10) removed................................................27345 (b)(6) and (f)(5) added........................................40060 (f)(3)(vi) added...............................................50401 558.363 (c) revised................................................24260 558.430 (a) amended................................................40729 558.450 (a)(2) revised.............................................27006 558.485 (a)(26) removed..............................................236 558.515 (d)(1)(vi)(b) amended......................................20843 558.530 (d)(4)(v) added.............................................1018 (d)(4)(vi) added...............................................24260 558.550 (b)(1)(vii)(c) and (ix)(c) amended.........................20843 (b)(1) (x) and (xi) added......................................35313 (b)(1)(xii) added..............................................44010 558.600 (c)(2) (i) and (ii) revised................................39257 558.635 (f)(2)(iv) added...........................................27852 (f)(3)(vi) added...............................................35313 (f)(3)(vi) revised.............................................44010 561 Redesignated as 40 CFR Part 186................................24666 Correctly redesignated as 40 CFR Part 186......................26131 561.20 (b), (c), and (d) removed....................................9435 561.55 Removed......................................................9435 561.90 Removed......................................................9435 561.96 (a) added....................................................1917 (c) added......................................................18837 561.98 (b), (c), and (d) removed....................................9435 561.175 Removed.....................................................9435 561.195 Removed.....................................................9435 561.197 Existing text designated as (a); (b) added; eff. to 6-30- 89.........................................................23386 561.225 (a) table amended...........................................5367 (a) table corrected.....................................11938, 12640 561.231 Removed.....................................................9435 561.237 Removed.....................................................9435 561.253 (b) removed.................................................9435 561.265 Removed.....................................................9435 561.273 (c) removed.................................................8874 561.277 Removed.....................................................8874 561.280 (b), (c), and (d) removed...................................9435 561.281 Removed.....................................................9435 561.320 Removed.....................................................9435 561.330 Revised.....................................................9435 561.371 Removed.....................................................9435 561.380 (b) removed.................................................9435 561.395 Removed.....................................................9435 561.400 Revised....................................................23389 561.415 Introductory text revised..................................23389 561.425 Revised....................................................23389 561.430 Table amended.........................................234, 23388 561.432 Revised.....................................................8874 561.433 Removed.....................................................8874 561.440 Introductory text amended..................................20308 561.441 Amended....................................................23107 561.443 Added; exp. 2-28-88...........................................21 Added..........................................................12943 561.444 Added......................................................15813 561.445 Added......................................................23387 573.225 Added......................................................40061 606 Authority citation revised.......................................116 606.121 (h) revised..................................................116 606.122 (e) revised..................................................116 610 Authority citation revised.......................................116 610.12 (g)(4)(i) revised...........................................12764 610.45 Added.........................................................116 610.53 (c) table amended...........................................12764 640 Authority citation revised.......................................116 640.2 (f) revised; OMB number........................................116 640.5 (f) added......................................................117 (b) and (c) amended............................................12764 640.14 Revised.......................................................117 640.23 (a) revised...................................................117 640.33 (a) revised...................................................117 640.53 (a) revised...................................................117 640.67 Revised.......................................................117 640.70 (a)(11) added.................................................117 640.71 (a)(4) added..................................................117 640.72 (a)(2) revised; OMB number....................................117 660.20--660.28 (Subpart C) Revised; eff. in part 4-19-89...........12764 660.29 Removed.....................................................12764 800 Authority citation revised; section authority citations removed....................................................11252 800.12 Second (c) removed..........................................11252 803.33 (b) amended.................................................11252 807.22 (a) amended.................................................11252 807.35 (b) amended.................................................11252 807.37 (a) and (b)(2) amended......................................11252 807.90 (a) amended.................................................11252 807.95 (c)(1) amended..............................................11252 808.87 (a) amended.................................................11252 808.98 (a) revised.................................................35314 809.5 (a)(1), (2), (3), and (4) and (b) amended....................11252 [[Page 238]] 812.2 (e) amended..................................................11252 812.19 Amended.....................................................11252 812.20 (b)(9) and (d) amended......................................11252 812.38 (d) amended.................................................11253 813.20 (a) amended.................................................11253 813.38 (b) and (c) amended.........................................11253 813.119 (e)(2) amended.............................................11253 813.160 (a) introductory text amended..............................11253 820.1 (d) amended..................................................11253 820.3 (f) amended..................................................11253 860.7 (g)(4) amended...............................................11253 860.123 (b)(1) amended.............................................11253 861.32 (b) and (c)(5) amended......................................11253 862.9 Added........................................................21448 862.1190 (b) corrected.............................................11645 (b) revised....................................................21449 862.1210 (b) revised...............................................21449 862.1255 (b) revised...............................................21449 862.1290 (b) revised...............................................21449 862.1295 (b) corrected.............................................11645 862.1305 (b) revised...............................................21449 862.1320 (b) revised...............................................21449 862.1365 (b) revised...............................................21449 862.1380 (b) revised...............................................21449 862.1420 (b) revised...............................................21449 862.1470 (b) revised...............................................21449 862.1490 (b) revised...............................................21449 862.1515 (b) revised...............................................21449 862.1565 (b) revised...............................................21449 862.1575 (b) revised...............................................21449 862.1640 (b) revised...............................................21449 862.1670 (b) revised...............................................21449 862.1680 (b) corrected.............................................11645 862.1695 Redundant printing correctly removed......................11645 862.1700 Redundant printing correctly removed......................11645 862.1705 Redundant printing correctly removed......................11645 862.1720 (b) corrected.............................................11645 (b) revised....................................................21449 862.1815 (b) revised...............................................21449 862.2100 (b) revised...............................................21449 862.3750 (b) revised...............................................21450 862.3850 (b) revised...............................................21450 Technical correction...........................................25050 864.9050 (a) amended...............................................11253 864.9160 (a) amended...............................................11253 866 Technical correction...........................................16837 866.5240 (a) amended...............................................11253 866.5890 (a) amended...............................................11253 876 Technical correction...........................................16837 876.5830 (a) amended...............................................11253 878 Added..........................................................23872 882.5840 (c) revised...............................................48621 884.2980 Added......................................................1566 Technical correction............................................5080 884.2982 Added......................................................1566 Technical correction............................................5080 886.9 Added........................................................35603 886.1040 (b) revised...............................................35603 886.1140 (b) revised...............................................35603 886.1150 (b) revised...............................................35603 (b) corrected..................................................40825 886.1170 (b) revised...............................................35603 886.1190 (b) revised...............................................35603 886.1200 (b) revised...............................................35604 886.1270 (b) revised...............................................35604 886.1320 (b) revised...............................................35604 886.1330 (b) revised...............................................35604 886.1350 (b) revised...............................................35604 886.1375 (b) revised...............................................35604 886.1380 (b) revised...............................................35604 886.1390 (b) revised...............................................35604 886.1395 (b) revised...............................................35604 886.1400 (b) revised...............................................35604 886.1410 (b) revised...............................................35604 886.1415 (b) revised...............................................35604 886.1420 (b) revised...............................................35604 886.1460 (b) revised...............................................35605 886.1500 (b) revised...............................................35605 886.1605 (b) revised...............................................35605 886.1650 (b) revised...............................................35605 886.1655 (b) revised...............................................35605 886.1660 (b) revised...............................................35605 886.1665 (b) revised...............................................35605 886.1700 (b) revised...............................................35605 886.1770 (b) revised...............................................35605 886.1790 (b) revised...............................................35605 (b) corrected..................................................40825 886.1800 (b) revised...............................................35605 886.1810 (b) revised...............................................35605 886.1840 (b) revised...............................................35605 Heading corrected..............................................40825 886.1860 (b) revised...............................................35606 886.1870 (b) revised...............................................35606 886.1880 (b) revised...............................................35606 886.1905 (b) revised...............................................35606 886.1910 (b) revised...............................................35606 886.4230 (b) revised...............................................35606 886.4335 (b) revised...............................................35606 886.4350 (b) revised...............................................35606 886.4360 (b) revised...............................................35606 886.4392 Added.....................................................38947 886.4445 (b) revised...............................................35606 886.4570 (b) revised...............................................35606 886.4770 (b) revised...............................................35606 886.4855 (b) revised...............................................35606 886.5120 (b) revised...............................................35607 886.5420 (b) revised...............................................35607 886.5540 (b) revised...............................................35607 [[Page 239]] 886.5600 (b) revised...............................................35607 886.5800 (b) revised...............................................35607 886.5810 (b) revised...............................................35607 886.5840 (b) revised...............................................35607 886.5844 (b) revised...............................................35607 886.5870 (b) revised...............................................35607 886.5910 (b) revised...............................................35607 886.5915 (b) revised...............................................35607 888.9 Added........................................................52953 888.4200 (b) revised...............................................52953 888.4210 (b) revised...............................................52953 888.4220 (b) revised...............................................52954 888.4230 (b) revised...............................................52954 888.5890 (b) revised...............................................52954 888.5940 (b) revised...............................................52954 888.5980 (b) revised...............................................52954 892 Added...........................................................1567 Technical correction............................................5080 895 Technical correction...........................................16837 895.21 (d)(1) amended..............................................11254 1002 Technical correction..........................................16837 1002.7 Nomenclature change.........................................11254 1002.10 Introductory text amended..................................11254 1002.20 (a) and (b) introductory text and (5) amended..............11254 1002.31 (c) amended................................................11254 1002.41 (a)(1) amended.............................................11254 1002.50 (a) introductory text and (b) amended......................11254 1002.51 Amended....................................................11254 1005.11 Amended....................................................11254 1005.25 (b) and (c) amended........................................11254 1010 Authority citation revised....................................52683 1010.2 (c) and (d) amended.........................................11254 1010.3 (a)(1) and (2)(i), (b), and (c) amended.....................11254 1010.4 (a) introductory text, (b)(1)(viii), (c)(1) and (3) amended 11254 (a) revised; (c)(2) removed; (c)(3) and (4) redesignated as (c)(2) and (3).....................................................52683 1010.5 (a) introductory text, (b), (c)(12), and (e)(1) and (2) amended....................................................11254 1010.13 Amended....................................................11254 1020.30 (c) and (d) introductory text and (3)(ii) amended..........11254 1020.32 (a)(1) amended.............................................11254 1030 Authority citation revised....................................11254 1030.10 (c)(4)(iv), (5)(iv), and (6)(iii), (iv) introductory text and (d) amended............................................11254 1040.30 (c)(1)(ii) amended.........................................11254 1050 Authority citation revised....................................11255 1050.10 (d)(5) amended.............................................11255 Chapter II 1301.11 (a) through (f) amended.....................................4963 1301.12 Amended.....................................................4963 1301.13 (a) through (c) amended.....................................4963 1301.22 (a)(4) and (b) (5) and (6) amended..........................4963 1301.32 (a) (1) through (6) and (8), (b) (1) through (9) and (c) amended.....................................................4963 1301.32 (d) revised; (e) and (f) redesignated as (f) and (g); new (e) added..................................................21813 1301.44 (a) and (b) amended.........................................4963 1301.61 Amended.....................................................4963 1303.12 (f) amended.................................................4963 1305.03 Introductory text amended...................................4963 1305.05 (a) revised; (b) amended....................................4963 1305.06 (a) and (b) amended.........................................4963 1306.11 (d) introductory text amended...............................4964 1308.11 (g)(2) removed; (b) (12) through (54) and (g) (3) through (6) redesignated as (b) (13) through (55) and (g) (2) through (5); new (b)(12) added...............................501 (d)(7) rdmoved; (d)(8) through (25) redesignated as (d)(7) through (24)........................................................2226 (b)(12) correctly revised.......................................3744 (d) (7) through (24) redesignated as (d) (8) through (25); new (d)(7) added........................................................5158 1308.11 (g)(6) added...............................................29233 (g) temporary scheduling extended..............................40061 1308.12 (f)(2) corrected; CFR correction...........................31837 (c) (6) through (24) redesignated as (c) (7) through (25); new (c)(6) added.......................................................43685 1308.14 (e) (1) through (6) redesignated as (e) (2), (5), and (7) through (10); new (e) (1), (3), (4), and (6) added.........17460 1308.15 (d) added..................................................10870 1308.24 (i) table revised...................................10835, 36152 1308.32 Table revised..............................................10861 1311.11 (a) and (b) amended.........................................4963 1311.12 Revised.....................................................4963 1311.32 (a), (b) and (c) amended....................................4963 [[Page 240]] 1311.43 (a) and (b) amended.........................................4963 1312.14 (a) amended................................................48244 1312.16 (b) amended................................................48244 1312.19 (a) and (b) amended........................................48244 1312.24 (a) amended................................................48244 1312.25 Amended....................................................48244 1312.28 (c) amended................................................48244 1312.31 (b) amended................................................48244 1312.32 (a) amended................................................48244 1989 21 CFR 54 FR Page Chapter I 1 Heading and authority citation revised...........................39630 1.4 Revised........................................................39630 1.24 (a)(6)(i), (ii), and (iii) amended.............................9033 1.96 (a)(3) amended.................................................9033 2 Authority citation revised; sectional authority citations removed....................................................39631 2.19 Amended........................................................9034 2.125 (d), (g), (h)(1) and (2) introductory text, and (i) amended 9034 5 Authority citation corrected......................................8053 5 Technical correction.............................................22278 Authority citation revised.....................................39631 5.10 (a)(7) amended.................................................9034 (a)(30) added..................................................20381 (a)(31) added..................................................48592 5.22 (a)(7)(vi) removed; (a)(12) redesignated as (a)(13); new (a)(12) added; (a)(7)(i) through (v), (9)(ii) and new (a)(13)(v) and (vi) revised.................................8315 (a)(12)(iv) corrected..........................................11866 (a)(7)(iv) and (v) revised.....................................43961 5.23 (b) and (e) revised............................................8315 5.25 (a)(1) and (3) revised; (a)(6) added...........................8316 5.26 Heading, (b), (c), and (d) revised; (g) redesignated as (h); new (g) added...............................................8316 5.30 (a)(2) and (c)(3) revised; (a)(5) through (7) and (c)(6) through (9) redesignated as (a)(6) through (8) and (c)(7) through (10); new (a)(5) and (c)(6) added...................8316 (c) introductory text amended...................................9034 5.31 (e)(2) amended; (f)(6) reserved; (f)(7) added..................6884 (a), (b)(1), (2), and (3), (c)(1), (d)(1) and (2), (e)(3), and (f)(1) through (5) revised; (e)(4) and (f)(6) added.................8316 (e)(5) added...................................................14797 5.37 (a)(1) revised; (a)(5) redesignated as (a)(6); new (a)(5) added.......................................................8317 5.44 (a)(1)(i), (ii), (b)(1)(i) through (iv), (c)(1) and (2) revised; (a)(1)(iii) and (iv) added; (c)(3) removed.........8317 5.45 (e) introductory text revised; (f) added.......................6518 (e)(1)(iii) and (iv) revised....................................8317 (c) introductory text amended...................................9034 5.47 (a)(3) and (4) revised.........................................8317 5.49 (b) revised....................................................8317 5.50 (b) revised....................................................8317 Heading corrected..............................................11866 5.52 (b) revised....................................................8317 5.53 (a)(2) and (b)(1)(ii) revised..................................8317 5.54 (b) revised....................................................8318 5.55 (b) revised....................................................8318 5.58 (c)(1) and (2) revised; (c)(3) removed.........................8318 5.59 (a)(2) revised.................................................8318 5.63 (b) amended....................................................9034 5.67 Introductory text revised......................................8318 5.68 Heading, (a), and (b) revised..................................8318 5.69 (a), (b), and (c) revised......................................8318 5.70 Revised........................................................8318 5.71 (a) revised; (b) redesignated as (d); new (b) and (c) added 8318 5.73 (a) through (d) revised........................................8317 5.74 (a) and (b) revised............................................8319 5.75 (a), (b), and (c) revised......................................8319 5.76 (a) through (d) revised........................................8319 5.78 (a)(1) and (2) revised.........................................8319 5.79 Removed........................................................8319 5.80 Introductory text removed; (a), (b), (c)(1)(i), (ii), (2)(ii), (d)(1), and (2) revised............................8319 5.82 Revised........................................................8319 5.94 (a) and (b) revised; (c) removed...............................8320 5.100 Revised......................................................11696 5.110 (c) amended...................................................9034 5.115 Revised......................................................11697 7 Authority citation revised; sectional authority citations removed....................................................39631 7.70--7.75 (Subpart D) Removed.....................................11519 [[Page 241]] 7.73 Introductory text amended......................................9034 10 Authority citation revised.......................................6885 Authority citation revised; sectional authority citations removed............................................................39631 10.1 Amended........................................................9034 (a) correctly designated.......................................11607 10.3 (a) amended....................................................6886 (a) and (b) amended.............................................9034 10.20 (c)(1)(v) amended.............................................9034 10.25 (a) amended...................................................9034 10.30 (b) and (h)(4) amended........................................9034 10.35 (d) amended...................................................9034 10.40 (b)(1)(ix) and (i)(1) amended.................................9034 10.45 (h) redesignated as (i); (i)(2)(i) amended; new (h) added.....6886 (f) amended.....................................................9034 10.50 (a)(2) amended................................................9034 10.55 (c) amended...................................................9035 10.80 (d)(2)(iii)(b) amended........................................9035 10.90 (b)(4) and (5) amended........................................9035 10.95 (d)(1) introductory text and (2) amended......................9035 10.100 (b)(3)(v) removed............................................9035 10.203 (b) amended..................................................9035 10.206 (a) amended..................................................9035 12 Authority citation revised; sectional authority citations removed....................................................39631 12.21 (a)(2) amended................................................9035 12.22 (a)(5)(i)(c) and (b) introductory text amended................9035 12.24 (b)(6) and (c) amended........................................9035 12.50 (a) amended...................................................9035 12.85 (a) amended...................................................9035 13 Authority citation revised................................9035, 39631 13.5 Authority citation removed....................................39631 13.15 (a) amended...................................................9035 13.25 (b) amended...................................................9035 14 Authority citation revised......................................39631 14.1 (a)(2)(ix) amended.............................................9035 14.20 (b)(9) amended................................................9035 14.22 (a)(1) amended................................................9035 14.75 (a)(6)(i) and (ii) amended....................................9035 14.80 (d) amended...................................................9035 14.84 (c)(1) amended................................................9035 14.100 Revised......................................................9036 (c)(3) added...................................................11698 14.125 (d) amended..................................................9037 14.171 (d), (e), and (f) amended....................................9037 15 Authority citation revised......................................39631 15.20 Authority citation removed...................................39631 16 Authority citation revised; sectional authority citations removed....................................................39631 16.1 (b)(2) amended.................................................9037 16.24 (c) amended...................................................9037 16.40 Amended.......................................................9037 16.42 (c)(1) amended................................................9037 16.119 Amended......................................................9037 19 Authority citation revised......................................39631 20 Authority citation revised.......................................9037 Authority citation revised; sectional authority citations removed............................................................39631 20.21 (b) amended...................................................9037 20.42 (c) amended...................................................9037 20.50 Amended.......................................................9038 20.81 (a)(3) amended................................................9038 20.100 (c)(13) amended; (c)(3), (14) through (17), and (21) revised.....................................................9038 20.103 (b) amended..................................................9038 20.112 (a) amended..................................................9038 20.117 (a)(3) and (b) amended.......................................9038 21 Authority citation revised......................................39631 21.45 (c) amended...................................................9038 21.71 (e)(4) amended................................................9038 25 Authority citation revised......................................39631 25.15 (c)(18) revised...............................................9038 25.22 (a)(14) amended...............................................9038 25.24 (c)(4) amended................................................9038 50 Authority citation revised................................9038, 39632 50.3 (b)(6) revised; (b)(11) amended................................9038 Authority citation removed.....................................39632 50.20--50.27 (Subpart B) Authority citation removed................39632 56 Authority citation revised................................9038, 39632 56.102 (b)(6) revised; (b)(10) amended..............................9038 58 Authority citation revised.........................9038, 15924, 39632 58.3 (e)(5) revised; (e)(9) amended.................................9039 58.90 (d) amended..................................................15924 58.195 (b)(1) amended...............................................9039 60 Authority citation revised......................................39632 70 Authority citation revised......................................39632 70.19 (p) amended..................................................24890 70.50 Authority citation removed...................................39632 [[Page 242]] 71 Authority citation revised; sectional authority citations removed....................................................39632 71.1 (c) amended...................................................24890 73 Authority citation revised; sectional authority citations removed....................................................39632 73.3107 Addition effective date confirmed...........................3775 73.3110a Addition effective date confirmed..........................3775 74 Authority citation revised; sectional authority citations removed....................................................39632 74.1336 Regulation at 53 FR 52130 effective date confirmed..........9200 80 Authority citation revised......................................39632 80.10 (d) amended..................................................24890 Authority citation removed.....................................39632 80.21 (j)(1) through (4) amended...................................24890 81 Authority citation revised; sectional authority citations removed....................................................39632 81.1 (a) table amended...............................27640, 35861, 43962 (b) table amended..............................................37307 81.27 (d) introductory text table amended.....27641, 35861, 37307, 43962 82 Authority citation revised; sectional authority citation removed....................................................39632 100 Authority citation revised; sectional authority citation removed....................................................39632 101 Authority citation revised.....................................39632 101.9 (a)(2), (c)(4), and (8) (i) and (ii) amended.................24891 101.22 (a)(3) amended..............................................24891 101.25 (e)(3) amended..............................................24891 101.29 Authority citation removed..................................39632 102 Authority citation revised.....................................39632 102.23 (c) (1) and (5) amended.....................................24891 103 Authority citation revised.......................................400 Effective date confirmed.......................................38514 Authority citation revised.....................................39632 Technical correction...........................................41363 103.35 (a)(1) amended................................................400 Effective date confirmed.......................................18651 (b) introductory text amended..................................24891 Authority citation removed.....................................39632 104 Authority citation revised.....................................39632 105 Authority citation revised; sectional authority citations removed....................................................39633 106 Authority citation revised.....................................39633 106.30 (c)(2) amended..............................................24891 106.120 (a) and (b) amended........................................24891 107 Technical correction............................................6804 Authority citation revised.....................................39633 107.200--107.280 (Subpart E) Added..................................4008 108 Effective date confirmed.......................................38514 Authority citation revised.....................................39633 Technical correction...........................................41363 108.5 (a)(1) amended...............................................24891 108.25 (c) (1) and (2) and (h) amended.............................24891 108.35 (c)(1), (2) introductory text and (ii), and (j)(1) amended 24891 109 Effective date confirmed.......................................38514 Authority citation revised.....................................39633 Technical correction...........................................41363 109.30 (c) and (d) amended.........................................24892 Authority citation removed.....................................39633 110 Authority citation revised.....................................39633 110.10 (b)(4) amended..............................................24892 110.35 (b)(1) introductory text amended............................24892 113 Authority citation revised.....................................39633 114 Authority citation revised.....................................39633 114.90 (a)(4)(ii) amended..........................................24892 129 Authority citation revised.....................................39633 130 Authority citation revised.....................................39633 130.17 (c) introductory text amended...............................24892 131 Effective date confirmed.......................................38514 Authority citation revised; sectional authority citations removed............................................................39633 Technical correction...........................................41363 131.110 (d) introductory text amended..............................24892 131.111 (f) introductory text amended..............................24892 131.112 (e) introductory text amended..............................24892 131.115 (d) introductory text amended..............................24892 131.120 (c) amended................................................24892 131.122 (c) amended................................................24892 131.123 (d) introductory text amended..............................24892 131.125 (c) introductory text amended..............................24892 131.127 (d) introductory text amended..............................24892 [[Page 243]] 131.130 (d) introductory text amended..............................24892 131.132 (d) introductory text amended..............................24892 131.135 (d) introductory text amended..............................24893 131.136 (f) introductory text amended..............................24893 131.138 (e) introductory text amended..............................24893 131.143 (d) introductory text amended..............................24893 131.144 (f) introductory text amended..............................24893 131.146 (e) introductory text amended..............................24893 131.147 (d) introductory text amended..............................24893 131.149 (c) introductory text amended..............................24893 131.150 (c) amended................................................24893 131.155 (c) amended................................................24893 131.157 (c) amended................................................24893 131.160 (c) introductory text amended..............................24893 131.162 (c) introductory text amended..............................24893 131.170 (f) introductory text amended..............................24893 131.180 (c) amended................................................24893 131.185 (c) introductory text amended..............................24893 131.187 (c) introductory text amended..............................24893 131.200 (e) introductory text amended..............................24893 131.203 (e) introductory text amended..............................24893 131.206 (e) introductory text amended..............................24893 133 Technical correction....................................37531, 41363 Effective date confirmed.......................................38514 Authority citations revised; sectional authority citations removed............................................................39633 133.5 Introductory text amended....................................24893 133.106 (a)(1) amended; (a)(2) removed; (a)(3) redesignated as (a)(2).....................................................32052 133.108 Revised....................................................32052 (d)(2) corrected...............................................35756 133.109 Revised....................................................32053 133.127 Revised....................................................32053 133.133 Revised....................................................32053 133.134 Revised....................................................32053 133.136 Revised....................................................32054 133.137 Revised....................................................32054 133.140 Revised....................................................32054 133.141 Revised....................................................32054 133.144 Revised....................................................32055 133.145 Revised....................................................32056 133.146 Revised....................................................32056 (d)(3)(iii) and (4)(i) corrected...............................35756 133.153 Revised....................................................32056 133.160 Revised....................................................32057 (a) and (d)(1) corrected.......................................35756 (d)(1) corrected...............................................37531 133.161 Revised....................................................32057 133.162 Revised....................................................32057 133.164 Revised....................................................32058 133.179 (f)(11) added; eff. 4-10-89.................................6121 Effective date confirmed.......................................22741 133.184 Revised....................................................32058 133.186 Revised....................................................32058 133.190 Revised....................................................32059 135 Effective date confirmed.......................................38514 Authority citations revised; sectional authority citations removed............................................................39633 Technical correction...........................................41363 135.110 (d) amended................................................24894 135.130 (c) introductory text amended..............................24894 136 Effective date confirmed.......................................38514 Authority citation revised; sectional authority citations removed............................................................39633 Technical correction...........................................41363 136.110 (d) amended................................................24894 136.160 (a)(5) amended.............................................24894 137 Effective date confirmed.......................................38514 Authority citation revised; sectional authority citations removed............................................................39633 Technical correction...........................................41363 137.105 (a) introductory text amended..............................24894 137.180 (c) introductory text amended..............................24894 137.190 Amended....................................................24894 137.195 Amended....................................................24894 137.200 (c)(1) amended.............................................24894 137.211 (b)(2) amended.............................................24894 137.230 (b)(2) amended.............................................24894 137.250 (b)(1) introductory text and (2) amended...................24894 137.270 (b) introductory text amended..............................24894 137.300 (b)(2) amended.............................................24894 137.350 (e) amended................................................24894 139 Effective date confirmed.......................................38514 [[Page 244]] Authority citation revised; sectional authority citations removed............................................................39633 Technical correction...........................................41363 139.110 (a)(5) amended.............................................24894 139.117 (a)(2) introductory text amended...........................24894 139.150 (a) concluding text amended................................24894 145 Effective date confirmed.......................................38514 Authority citation revised; sectional authority citations removed............................................................39633 Technical correction...........................................41363 145.3 (m) amended..................................................24894 145.110 (a)(1) amended.............................................24894 145.125 (b)(2)(ii) amended.........................................24894 145.135 (b)(1)(i) amended..........................................24895 145.145 (a)(3)(iii) introductory text amended......................24895 146 Effective date confirmed.......................................38514 Authority citation revised; sectional authority citations removed............................................................39633 Technical correction...........................................41363 146.113 (a) amended................................................24895 146.114 (a)(1) amended.............................................24895 146.120 (a) amended................................................24895 146.185 (b)(2)(i) amended..........................................24895 150 Effective date confirmed.......................................38514 Authority citation revised; sectional authority citations removed............................................................39633 Technical correction...........................................41363 150.110 (d)(3) amended.............................................24895 150.140 (d)(3) amended.............................................24895 150.160 (d)(5) amended.............................................24895 152 Authority citation revised.....................................39633 152.126 Authority citation revised.................................39633 155 Effective date confirmed.......................................38514 Authority citation revised; sectional authority citations removed............................................................39634 Technical correction...........................................41363 155.3 (a) and (e) amended..........................................24895 155.120 (b)(2)(i) amended..........................................24895 155.130 (b)(2)(i) amended..........................................24895 155.170 (b)(1)(vi) amended.........................................24895 156 Authority citation revised.....................................24895 Effective date confirmed.......................................38514 Authority citation revised; sectional authority citations removed............................................................39634 Technical correction...........................................41363 156.3 (b) amended..................................................24895 158 Authority citation revised; sectional authority citations removed....................................................39634 160 Effective date confirmed.......................................38514 Authority citation revised.....................................39634 Technical correction...........................................41363 160.145 (c)(2) amended.............................................24895 160.180 Amended....................................................24895 Authority citation removed.....................................39634 161 Effective date confirmed.......................................38514 Authority citation revised; sectional authority citations removed............................................................39634 Technical correction...........................................41363 161.145 (c)(3) amended.............................................24895 161.173 (c)(1) amended.............................................24896 161.175 (g)(1)(v) amended..........................................24896 161.190 (a)(2), (7) introductory text and (iii) amended............24896 163 Effective date confirmed.......................................38514 Authority citation revised; sectional authority citation removed............................................................39634 Technical correction...........................................41363 163.110 (a) amended................................................24896 163.111 (a) concluding text amended................................24896 163.112 (a) concluding text amended................................24896 164 Effective date confirmed.......................................38514 Authority citation revised.....................................39634 Technical correction...........................................41363 164.150 (a) amended................................................24896 Authority citation removed.....................................39634 165 Removed..........................................................400 165.175 Effective date confirmed...................................18651 166 Authority citation revised.....................................24896 Effective date confirmed.......................................38514 Authority citation revised; sectional authority citations removed............................................................39634 Technical correction...........................................41363 166.110 (a) introductory text amended..............................24896 168 Effective date confirmed.......................................38514 Authority citation revised; sectional authority citations removed............................................................39634 Technical correction...........................................41363 168.111 (d) introductory text amended..............................24896 168.120 (d) introductory text amended..............................24896 168.122 (d)(1) introductory text amended...........................24896 [[Page 245]] 169 Effective date confirmed.......................................38514 Authority citation revised; sectional authority citations removed............................................................39634 Technical correction...........................................41363 169.3 (b) amended..................................................24896 170 Authority citation revised; sectional authority citations removed....................................................39634 170.3 (n) and (o) introductory text amended........................24896 170.6 (e) amended..................................................24896 170.38 (b)(3) amended..............................................24896 171 Authority citation revised.....................................39634 172 Authority citation revised; sectional authority citations removed....................................................39634 172.105 (b) (1), (2), and (3) amended..............................24896 172.250 (b)(3) footnote 1 amended..................................24896 172.320 (b)(2), (c)(1), and (d) amended............................24897 172.340 (b) introductory text footnote 1 amended...................24897 172.372 (d) amended................................................24897 172.385 (c)(1) amended.............................................24897 172.510 (b) table footnote 1 amended...............................24897 172.515 (b) amended.................................................7402 172.804 (c)(19) added..............................................23647 (c)(20) added..................................................23647 (c)(21) added..................................................31333 172.859 (b) (1), (5), and (9) amended..............................24897 172.860 (c) (1) and (2) amended....................................24897 172.864 (b)(3) footnote 1 amended..................................24897 172.878 (a)(3) amended.............................................24897 172.882 (a) amended................................................24897 172.886 (b) footnote 1 amended.....................................24897 173 Authority citation revised; sectional authority citations removed....................................................39634 173.60 (b)(3) amended..............................................24897 173.145 (b) footnote 1 amended.....................................24897 173.160 (b)(1) footnote 1 and (2) amended..........................24897 173.165 (b)(2) amended.............................................24897 173.310 (c) table amended..........................................31012 173.395 (d) amended................................................24897 174 Authority citation revised.....................................39634 175 Authority citation revised.....................................39634 175.105 (c)(5) table amended.........................15750, 24554, 50500 175.300 (b)(3)(xix) amended........................................24897 (b)(3)(xxxiii) amended...........................30732, 47765, 47766 (b)(3)(vii)(e) added...........................................48858 176 Authority citation revised.....................................39634 176.170 (a)(5) table amended................................19363, 38968 Authority citation removed.....................................39634 (d)(3) introductory text amended...............................24897 176.180 (b)(2) table amended.........................10630, 13881, 14075 Technical correction...........................................13606 176.210 (d)(3) amended.............................................24897 176.300 (c) table revised..........................................18103 177 Authority citation revised; sectional authority citations removed....................................................39634 177.1020 (c)(2) and (d)(2) amended.................................24897 177.1030 (c)(2) and (d)(2) amended.................................24898 177.1050 (b) table, (c) (2) and (3), (d) introductory text, and (e)(4) amended.............................................24898 177.1060 Added.....................................................20382 177.1330 (e)(4) amended............................................24898 177.1350 (d) (1), (3), and (e)(1) revised..........................35874 177.1390 (c)(3)(i)(a)(1) amended...................................24898 177.1480 (b)(2) introductory text amended..........................24898 177.1500 (b) table amended.........................................29019 177.1520 (b) table amended.........................................10632 (a)(5) added; (c) table amended................................40383 (a)(3)(i)(c) redesignated as (a)(3)(i)(c)(1); (a)(3)(i)(c)(2) added; (c) table amended; (d)(7) revised...........................49079 (c) table corrected............................................51342 177.1550 (e) footnote 1 amended....................................24898 177.1630 (j) added.................................................15750 Technical correction...........................................19283 (e)(4)(iii) amended............................................24898 177.1635 (c)(1) amended............................................24898 177.1810 (c)(2)(ii) amended........................................24898 177.1820 (c)(3) amended............................................24898 177.1990 (c)(1) amended............................................24898 177.2210 (b)(3) amended............................................24898 177.2420 (b) table amended.........................................48858 177.2450 (b) (1), (2), and (3) amended.............................24898 (a) and (b) revised; (c) introductory text amended.............43170 177.2470 (c)(2) amended............................................24898 177.2480 (d)(2)(i) amended.........................................24898 [[Page 246]] 177.2490 (a) introductory text amended.............................24898 177.2600 (c)(4)(iv) heading revised and text amended...............35638 (c)(4)(i) amended..............................................38969 178 Authority citation revised.....................................39634 178.1005 (e)(1) table amended................................5604, 13167 (e)(1) table corrected..........................................6365 178.1010 (b)(36) and (c)(31) added.................................21621 (b)(38) and (c)(33) added......................................21939 (b)(36) corrected..............................................23739 Technical correction...........................................24789 (b)(16) amended................................................24898 (b)(37) and (c)(32) added......................................31014 178.2010 (b) table amended...............6125, 9775, 13878, 17705, 39357 Technical correction...........................................42886 178.2650 Introductory text and (a) introductory text revised; (a)(7) and (b)(1)(iii) added................................6658 (b)(1)(ii) amended.............................................24898 178.3295 Table amended.............................................12432 Table corrected................................................14734 178.3297 (e) table amended..................................21053, 35875 (c) amended....................................................24898 178.3480 (c) introductory text amended.............................24898 178.3570 (a)(3) table amended......................................31519 178.3610 (a) amended...............................................24898 178.3620 (b)(1)(ii) and (c)(3) footnote 1 amended..................24898 178.3690 (b)(4) amended............................................24898 178.3770 (a)(4) footnote 1 amended.................................24898 178.3780 (b)(1) amended............................................24899 178.3870 (f)(6)(iv) amended........................................24899 178.3910 (a)(2) table amended.......................................6124 Technical correction............................................7920 (a)(4)(iii) footnote 1 and (b) introductory text amended.......24899 179 Authority citation revised.....................................39634 179.26 Technical correction.........................................6475 Regulation at 53 FR 53209 effective date confirmed.............32335 179.45 (c) and (d) redesignated as (d) and (e); new (c) added.......7405 (b)(6) introductory text amended...............................24899 180 Authority citation revised.....................................39635 180.1 Authority citation removed...................................39634 180.22 (a) introductory text, (b), (e), and (f) (1) and (2) amended....................................................24899 181 Authority citation revised.....................................39635 181.1 Authority citation removed...................................39635 181.32 (b) introductory text amended...............................24899 182 Authority citation corrected....................................6365 Authority citation revised.....................................39635 182.60 Amended......................................................7402 182.90 Amended......................................................7402 182.1324 Removed....................................................7402 182.1901 Removed....................................................7402 182.4101 Removed....................................................7402 182.4505 Removed....................................................7402 182.4521 Removed....................................................7402 184 Authority citation revised.....................................39635 184.1101 Added......................................................7403 (a) revised; (e) added; eff. 5-1-89............................13168 Effective date and (e) corrected...............................18382 184.1323 Added......................................................7403 184.1324 Added......................................................7403 184.1408 (b)(1) amended............................................24899 184.1472 Added.....................................................38223 184.1505 Added......................................................7403 184.1521 Added......................................................7404 184.1854 (b) corrected...............................................228 184.1859 (a) corrected...............................................228 184.1901 Added......................................................7404 184.1903 Added......................................................7404 (c)(2) corrected...............................................10482 184.1979 (b)(1) introductory text footnote 2 amended...............24899 184.1979a (b)(1) introductory text footnote 2 amended..............24899 184.1979b (b)(1) introductory text footnote 2 amended..............24899 184.1979c (b)(1) introductory text footnote 2 amended..............24899 186 Authority citation revised.....................................39635 189 Authority citation revised; sectional authority citations removed....................................................39635 189.1 (c) amended..................................................24899 189.110 (c) amended................................................24899 189.130 (c) amended................................................24899 189.135 (c) amended................................................24899 189.145 (c) amended................................................24899 189.155 (c) amended................................................24899 189.165 (c) amended................................................24900 189.175 (c) amended................................................24900 189.180 (c) amended................................................24900 189.190 (c) amended................................................24900 189.300 Added.......................................................7188 197 Authority citation revised.....................................39635 [[Page 247]] 200 Authority citation revised; sectional authority citations removed....................................................39635 201 Authority citation revised; sectional authority citations removed....................................................39635 202 Authority citation revised.....................................39635 202.1 Authority citation removed...................................39635 207 Authority citation revised.....................................39635 207.35 Authority citation removed..................................39635 210 Authority citation revised.....................................39635 211 Authority citation revised......................................5228 Authority citation revised; sectional authority citations removed............................................................39635 211.132 Revised; eff. 2-2-90........................................5228 225 Authority citation revised.....................................39635 226 Authority citation revised.....................................39635 250 Authority citation revised; sectional authority citations removed....................................................39635 290 Authority citation revised.....................................39635 290.6 Authority citation removed...................................39635 291 Authority citation added; sectional authorities removed.........8960 Authority citation revised.....................................39635 291.505 Revised; eff. 4-3-89........................................8960 (b)(2)(i) and (d)(1)(iv) corrected.............................12531 299 Authority citation revised; sectional authority citations removed....................................................39635 300 Authority citation added; sectional authority citations removed....................................................39636 310 Authority citation revised; sectional authority citations removed....................................................39636 310.501 Revised....................................................22587 310.501a Removed...................................................22588 310.516 (f) and (g) revised.........................................1163 310.527 Added......................................................28777 Technical correction...........................................31405 Clarification..................................................50364 310.528 Added......................................................28786 Clarification..................................................50364 312 Authority citation revised.....................................39636 314 Authority citation revised.....................................39636 320 Authority citation revised; sectional and subpart authority citations removed..........................................39636 329 Authority citation revised.....................................39636 329.1 Authority citation removed...................................39636 330 Authority citation revised.....................................39636 331 Authority citation revised.....................................39636 332 Authority citation revised.....................................39636 333 Authority citation revised.....................................39636 336 Authority citation revised.....................................39636 338 Added...........................................................6826 Authority citation revised.....................................39636 340 Authority citation revised.....................................39636 341 Policy statement...............................................36762 Authority citation revised.....................................39636 341.3 (d) added.....................................................8509 Technical correction...........................................11866 341.18 Added........................................................8509 Technical correction...........................................11866 341.78 Added........................................................8509 Technical correction...........................................11866 341.90 (d) added....................................................8509 Technical correction...........................................11866 344 Authority citation revised.....................................39636 349 Authority citation revised.....................................39636 357 Authority citation revised.....................................39636 357.210 Revised.....................................................8321 357.250 (d)(2) and (3) revised......................................8321 357.280 Revised.....................................................8321 361 Authority citation revised.....................................39636 369 Authority citation revised.....................................39636 429 Authority citation revised.....................................39636 430 Authority citation revised; sectional authority citations removed....................................................39637 430.4 (a)(60) added................................................20784 430.5 (a)(94) and (b)(96) added....................................20784 (a)(95) and (b)(97) added......................................38224 430.6 (b)(96) added................................................20784 (b)(97) added..................................................38224 (b)(34) amended................................................47204 431 Authority citation revised; sectional authority citations removed....................................................39637 432 Authority citation revised.....................................39637 432.1 Authority citation removed...................................39637 433 Authority citation revised.....................................39637 436 Authority citation revised; sectional authority citations removed....................................................39637 436.215 (b) table footnote and (c)(10)(iii) amended................47204 (b) table amended; (c)(11) added...............................48859 436.216 (c) (1) and (2) revised; (c)(5) added......................47351 436.357 Heading revised; (c)(2) amended............................20785 [[Page 248]] 436.365 Added......................................................38375 (e) corrected..................................................42886 436.366 Added......................................................20383 (g)(3) corrected...............................................25849 436.367 Added......................................................48860 (c) corrected..................................................51816 436.542 (b)(2) amended.............................................41824 440 Authority citation revised; sectional authority citations removed....................................................39637 440.9a (a)(1) (vii) and (viii) revised.............................47204 440.103b (b)(4) revised............................................47351 440.209b (b)(1)(iii) (B) and (C) amended...........................47205 441 Authority citation revised.....................................39637 442 Authority citation revised.....................................39637 442.15 (a)(1), (b)(1)(ii) (A), (C) and (iii)(E) amended............47205 442.16 Added.......................................................40652 442.18 Added.......................................................40654 Heading corrected..............................................50686 442.19 (b)(1)(iv) revised..........................................47351 442.20a (a)(1)(vi) amended.........................................41824 Corrected......................................................43384 442.28 Added.......................................................48860 442.58a Added......................................................20785 442.104b (a)(1) amended............................................41824 442.106b (a)(1) amended............................................47352 442.119 (b)(1)(iii) revised........................................47352 (b)(1)(iii) corrected..........................................50472 442.128 Added......................................................48860 442.212b (a)(1) amended............................................47352 442.216 Redesignated as 442.216a; new 442.216......................40652 442.216a Redesignated from 442.216.................................40652 442.216b Added.....................................................40652 442.218 Redesignated as 442.218a; new 442.218 added................40654 442.218a Redesignated from 442.218.................................40654 442.218b Added.....................................................40654 442.258 Added......................................................20786 444 Authority citation revised; sectional authority citations removed....................................................39637 444.380c Added.....................................................13879 446 Authority citation revised; sectional authority citations removed....................................................39637 446.60 (b)(1)(iii)(e) and (iv) amended.............................47205 446.115c Removed...................................................47352 446.116b Removed...................................................47352 446.116d Removed...................................................47352 446.165c Removed...................................................47352 446.165e Removed...................................................47352 446.180a Removed...................................................47352 446.180b Removed...................................................47352 446.181a Removed...................................................47352 446.181b Removed...................................................47352 446.260 (b)(1)(ii)(a) amended......................................47205 448 Authority citation revised; sectional authority citations removed....................................................39637 448.330 Added......................................................38376 449 Authority citation revised; sectional authorities removed......39637 450 Authority citation revised; sectional authorities removed......39637 452 Authority citation revised; sectional authority citations removed....................................................39637 452.510b (a)(2) revised............................................47352 (a)(2) corrected...............................................50472 453 Authority citation revised; sectional authority citations removed....................................................39637 453.120 (a)(1) amended.............................................41824 (a)(1) corrected...............................................43384 453.222 (a)(1) and (b)(1) revised..................................43289 453.522 Redesignated as 453.522a; new 453.522 added................38224 453.522a Redesignated from 453.522.................................38224 453.522b Added.....................................................38224 453.522c Added.....................................................40655 455 Authority citation revised; sectional authority citations removed....................................................39637 455.4 Added........................................................40385 455.82a (b)(1)(iii)(B) amended.....................................47205 455.204 Redesignated as 455.204a; new 455.204 added................40385 (a)(1) and (b)(1)(iv)(a)(3) amended; (a)(3)(i)(a) revised......41824 455.204a Redesignated from 455.204.................................40385 455.204b Added.....................................................40385 455.270 Added......................................................38375 455.285 Added......................................................20384 455.285b Added.....................................................20384 (a)(3)(ii)(B)(1) corrected.....................................22838 460 Authority citation revised.....................................39637 460.42 Authority citation removed..................................39637 500 Authority citation revised.....................................39637 500.27 (d) amended.................................................18279 500.35 (a) amended.................................................18279 [[Page 249]] 500.49 Authority citation removed..................................39637 500.51 (c) amended.................................................18279 501 Authority citation revised; sectional authority citations removed....................................................39637 501.3 (e)(3) revised...............................................18279 501.105 (b)(3) amended.............................................18279 502 Authority citation revised; sectional authority citations removed....................................................39637 505 Authority citation revised; sectional authority citations removed....................................................39638 505.10 Removed.....................................................18279 507 Authority citation revised.....................................39638 508 Authority citation revised.....................................39638 508.5 (a)(1) amended...............................................18279 508.35 (c) (1) and (2) introductory text, (ii), (j)(1), and (l) amended....................................................18280 509 Authority citation revised.....................................39638 509.5 Amended......................................................18280 510 Technical correction........................6232, 8880, 25447, 41713 Authority citation revised; sectional and subpart authority citations removed..................................................39638 510.3 (g)(2) amended; (g)(3) removed...............................22741 510.5 Removed......................................................22741 510.6 Removed......................................................22741 510.55 Removed.....................................................22741 510.110 (f) amended................................................18280 510.112 (a) and (e) amended........................................18280 510.301 Introductory text amended..................................18280 510.302 (d) amended................................................18280 510.310 (f) amended................................................18280 510.350 Removed....................................................22741 510.510 Removed....................................................22741 510.520 Removed....................................................22741 510.521 Removed....................................................22742 510.600 (c) (1) and (2) tables amended.............................1163, 1164, 6659, 7406, 17705, 22885, 24901, 25565, 26958, 27328, 32632, 33673, 38514, 38515, 38646, 40657, 41442, 43290, 47678, 50365, 51021 (c)(1) table corrected..........................................9979 Authority citation revised; sectional and subpart authority citations removed..................................................39638 511 Authority citation revised..............................18280, 39638 511.1 (c)(1) and (e) amended.......................................18280 Authority citation removed.....................................39638 514 Technical correction...........................................25447 Authority citation revised; sectional authority citations removed............................................................39638 514.1 (b)(6) introductory text, (d)(2) introductory text, (i), and (ii) amended...............................................18280 (d)(2) introductory text and (i) corrected.....................20235 (b)(9) removed.................................................22742 514.11 (e)(2)(ii)(a) and (b) amended...............................18280 Heading corrected..............................................20235 514.50 Removed.....................................................22742 514.51 Removed.....................................................22742 514.55 Removed.....................................................22742 514.60 Removed.....................................................22742 514.111 (a)(5)(ii)(a)(6) amended...................................18280 514.150 Removed....................................................22742 514.155 Removed....................................................22742 514.160 Removed....................................................22742 520 Technical correction...............................6232, 8880, 22278 Effective date corrected.......................................33814 Authority citation revised; sectional authority citations removed............................................................39638 520.45 Added.......................................................25115 520.45a Added......................................................25115 520.45b Added......................................................51385 520.260 (a)(2) amended.............................................38515 520.312 Added......................................................32336 520.443 Removed....................................................30205 520.446 (c) revised................................................47767 520.447 (c) revised................................................47766 520.580 (b)(1) amended..............................................1164 (b)(1) revised..................................................6659 520.623 (c)(2) revised..............................................3776 (c)(2) corrected................................................6804 520.812 Added.......................................................3444 520.816 Added......................................................50615 520.905e (a) and (d)(3) revised....................................20787 520.1100 (c) revised; (d) (3) and (4) redesignated as (d) (2) and (3)........................................................30205 520.1162 Removed....................................................1686 520.1193 Section heading and (a) revised...........................32337 520.1236 Removed...................................................29543 520.1242a (f)(2)(ii)(a) amended....................................18280 520.1242g (f)(3) amended............................................1353 520.1660d (d) amended..............................................18280 520.1720a (b)(4) amended...........................................22885 520.1760 Removed...................................................30205 520.1780 Removed...................................................30205 [[Page 250]] 520.1801a (d) removed...............................................1163 520.1801c Removed...................................................1163 520.1803 (b) amended...............................................38515 520.1840 (c)(4) and (d)(4) added...................................33501 520.2080b Removed..................................................30205 520.2184 (b) amended...............................................12188 520.2220d Added....................................................48593 520.2260a Revised..................................................15751 (a)(3)(ii)(A) corrected........................................19283 520.2260b (h) added................................................14341 520.2320 (b)(1)(iii) amended.......................................18280 520.2560 Removed....................................................1164 522 Technical correction............................................6232 Authority citation corrected....................................9590 Authority citation revised; sectional authorities removed......39638 522.443 Removed....................................................30205 522.514 Added......................................................17706 522.536 Added......................................................50365 Heading and (a) corrected......................................51551 522.540 (d)(2)(i) and (e)(2) amended...............................41442 522.850 (b) amended.................................................1165 522.914 (e) (1), (2) and (3) redesignated as (e)(1) (i), (ii), and (iii); (a) and new (e)(1)(i) heading revised; new (e)(2) added........................................................400 522.1077 Added.....................................................50235 522.1182 (a)(2) removed............................................41442 522.1235 Removed...................................................29543 522.1462 (b) amended...............................................32632 522.1662a (f) and (j) removed......................................41442 522.1680 (b) amended...............................................41442 522.1720 (b)(2) amended............................................41442 522.1800 Removed...................................................30205 522.1850 Revised...................................................53053 522.1940 (d)(1)(iii) amended........................................7406 522.2063 (b) amended................................................1164 522.2220 (c)(2), (3)(i), and (ii) revised; (c)(3)(iii) removed; (c)(3)(iv) redesignated as (c)(3)(iii).....................30205 522.2670 Added.....................................................40657 522.2680 (f)(1)(iii) amended; (f)(3)(iii) removed..................31950 524 Technical correction............................................6232 524 Authority citation revised.....................................39638 524.1580b (b) revised..............................................29544 (b) amended....................................................37097 524.1580c (b) revised..............................................30542 524.1600a (b) revised.......................................32633, 48090 (b) amended.....................................................5431 524.1742 (b) amended...............................................51021 524.2080 Removed...................................................30205 524.2101 (c) introductory text amended; (d) removed................36962 524.2542 Removed....................................................1164 524.2620 (b)(2) amended............................................25565 526 Authority citation revised.....................................39638 529 Authority citation revised.....................................39638 529.1030 (b) amended................................................5432 529.1186 (c) revised...............................................23472 536 Authority citation revised.....................................39638 539 Authority citation revised; sectional authority citations removed....................................................39638 540 Authority citation revised; sectional authority citations removed....................................................39638 540.181b (c)(1) amended............................................18280 540.255c (c)(2)(i) amended; (c)(2)(ii) revised.....................41442 540.274b (c)(3)(ii) and (5)(i) revised.............................33673 (c)(4) removed.................................................41442 544 Authority citation revised; sectional authority citations removed....................................................39638 544.275 (c)(2) and (4)(iii) amended................................41442 546 Technical correction............................................6232 546 Authority citation revised; sectional authority citations removed....................................................39638 546.110b (b)(2) amended............................................18281 546.180a (c)(5)(i)(c) amended; eff. 4-3-89.........................11698 Correctly redesignated.........................................12989 Correctly designated...........................................13977 548 Authority citation revised.....................................39638 548.112b Removed...................................................30206 555 Authority citation revised; sectional authority citations removed....................................................39638 555 Technical correction............................................6232 555.110b (c)(2) amended............................................26958 555.210 (c)(2) amended.............................................41442 556 Authority citation corrected...................................20235 Authority citation revised.....................................39638 556.34 Added.......................................................25115 556.250 (b) amended................................................18281 556.308 Revised....................................................28052 556.340 Removed.....................................................1686 556.344 (a) amended................................................18281 556.375 Added.......................................................5229 556.420 (a) revised................................................32633 556.739 Amended....................................................12595 556.760 Introductory text removed; (a) and (b) introductory text added......................................................31950 558 Authority citation revised.....................................39639 [[Page 251]] Technical correction...........................................41713 558.3 (b)(4) amended...............................................51386 558.4 (d) table amended......1686, 1928, 5229, 9430, 18281, 32633, 53319 (d) table corrected............................................40657 558.15 (g)(1) table amended........................................37098 (g) introductory text amended..................................51386 558.62 (c)(2)(iii) amended.........................................18281 558.76 (d)(1)(x) table amended......................................7189 (a) revised....................................................12189 (d)(3)(xiii) added.............................................29335 (d)(3)(xiv) added..............................................32635 558.95 (b)(4)(ii) added.............................................5930 558.128 (c)(5) (vii) and (viii) redesignated as (c)(5) (vi) and (vii); new (c)(5)(viii) added..............................24901 (c)(5)(xi) redesignated as (c)(5)(xii); new (c)(5)(xi) added 25115 (c)(5)(xiii) added.............................................26732 558.175 (a)(1) and (2) amended......................................6518 558.195 (c)(3) added; (d) table amended............................11183 558.248 (a) (3), (4), and (5) removed; (d)(1) table amended; eff. 4-3-89.....................................................12189 558.258 (c)(3) added...............................................36963 558.265 (c) revised................................................28052 (c)(7) added...................................................11519 558.274 (a)(4) and (c)(1) table amended; eff. 4-7-89...............12596 (a)(2) and (c)(1) table amended................................51021 558.305 Removed.....................................................1686 558.311 (b)(6) added...............................................29544 558.325 (c)(3)(xiv) added..........................................11520 (c)(3)(xv) added...............................................21940 (c)(3)(xv) revised.............................................23209 558.340 Added.......................................................5229 (c)(2) and (3) redesignated as (c)(1)(i) and (ii); new (c)(2) added..............................................................26732 Technical correction...........................................24789 (c)(3) added...................................................32635 (c)(4) added...................................................33885 558.355 (b)(14), (d) (3), (10), (11), and (f)(6) added.............32633 558.363 (a) revised; (c)(1)(iii) added..............................1928 (a)(4) and (c)(1)(iv) added.....................................5930 (c)(1)(iii)(B) amended..........................................9430 (c)(1)(v) added................................................29335 558.366 (c) table amended...........................................1928 558.485 (a)(24) removed.............................................3776 558.530 (d)(4)(vii) added..........................................24901 (d)(3)(xxiii) added............................................29335 (d)(3)(xxiv) added.............................................33885 558.550 (b)(1)(xiii) added.........................................21940 (b)(1)(xiv) added..............................................23209 Technical correction...........................................24789 (b)(1)(xv) added...............................................24901 (b)(1)(xvi) added..............................................25116 (b)(1)(xv)(b) corrected........................................28154 (b)(1)(xvi)(c) corrected.......................................32963 558.575 (c)(3)(ii) removed; (c)(3)(i)(a) and (b) redesignated as (c)(3) (ii) and (iii).......................................1686 558.625 (b)(33) revised; (f)(1)(i)(b) amended......................10980 (b)(38) amended................................................38646 558.630 (b)(3) amended...............................................109 (b)(10) amended.................................................3776 (b)(4) removed.................................................51021 (b)(10) amended................................................51021 564 Authority citation revised.....................................39639 564.17 (k) amended.................................................18281 570 Authority citation revised; sectional authority citations removed....................................................39639 570.6 (e) amended..................................................18281 570.35 (c) (2) and (3) amended.....................................18281 570.38 (b) (1) and (2) amended.....................................18281 571 Authority citation revised; sectional authority citations removed....................................................39639 573 Opportunity for comment........................................29019 Comment time extended..........................................33673 Authority citation revised; sectional authority citations removed............................................................39639 573.460 (a)(1) footnote 1 amended..................................18281 573.640 (b)(4) (i) and (ii) amended................................18281 573.780 (b)(1) amended.............................................18282 573.920 (a) revised; (f) added.....................................14215 (f)(3) corrected...............................................15874 579 Authority citation revised.....................................39639 582 Authority citation revised.....................................39639 582.99 Authority citation removed..................................39639 582 Authority citation revised.....................................39639 584.200 Authority citation removed.................................39639 589 Authority citation revised.....................................39639 600 Authority citation revised; sectional authority citations removed....................................................39639 601 Authority citation revised; sectional and subpart authority citations removed..........................................39639 [[Page 252]] 606 Authority citation revised..............................24707, 39639 607 Authority citation revised.....................................39639 610 Authority citation revised; sectional authority citations removed....................................................39639 620 Authority citation revised; sectional authority citations removed....................................................39639 630 Authority citation revised; sectional authority citations removed....................................................39639 640 Authority citation revised; sectional authority citations removed....................................................39639 650 Authority citation revised; sectional authority citations removed....................................................39640 660 Authority citation revised; sectional and subpart authority citations removed..........................................39640 680 Authority citation revised; sectional authority citations removed....................................................39640 700 Authority citation revised.....................................27342 Authority citation revised; sectional authority citations removed............................................................39640 700.19 Added.......................................................27342 701 Authority citation revised; sectional authority citations removed....................................................39640 701.3 (c)(2)(iv) amended...........................................24900 710 Authority citation revised.....................................39640 710.4 Authority citation removed...................................39640 720 Authority citation revised.....................................39640 730 Authority citation revised.....................................39640 740 Authority citation revised.....................................39640 740.11 Authority citation removed..................................39640 800 Authority citation revised.....................................39640 801 Authority citation revised; sectional authority citations removed....................................................39640 801.420 (c)(4) amended; eff. 6-19-90...............................52396 801.430 (e) and (f) redesignated as (g) and (h); (b), (d) introductory text, (2), (3) and (4), new (g), and new (h) revised; new (e) and new (f) added.........................43771 803 Authority citation revised.....................................39640 805 Authority citation revised.....................................39640 807 Authority citation revised; sectional authority citations removed....................................................39640 808 Authority citation revised.....................................39640 809 Authority citation revised; sectional authority citations removed....................................................39640 812 Authority citation revised; sectional authority citations removed....................................................39640 813 Authority citation revised; sectional authority citations removed....................................................39641 814 Authority citation revised.....................................39641 820 Authority citation revised.....................................39641 860 Authority citation revised.....................................39641 861 Authority citation revised.....................................39641 861.26 Authority citation removed..................................39641 862 Authority citation revised.....................................39641 862.1113 Added.....................................................30206 864 Authority citation revised.....................................39641 864.9 Added........................................................25043 Effective date added...........................................26958 864.1850 (b) revised...............................................25044 Effective date added...........................................26958 864.2220 (b) revised...............................................25044 Effective date added...........................................26958 864.2240 (b) revised...............................................25044 Effective date added...........................................26958 864.2260 (b) revised...............................................25044 Effective date added...........................................26958 864.2360 (b) revised...............................................25044 Effective date added...........................................26958 864.2800 (b) revised...............................................25044 Effective date added...........................................26958 864.2875 (b) revised...............................................25044 Effective date added...........................................26958 864.3010 (b) revised...............................................25044 Effective date added...........................................26958 864.3250 (b) revised...............................................25044 Effective date added...........................................26958 Revised........................................................47206 864.3300 (b) revised...............................................25044 Effective date added...........................................26958 864.3400 (b) revised...............................................25044 Effective date added...........................................26958 864.3600 (b) revised...............................................25044 Effective date added...........................................26958 864.3800 (b) revised...............................................25044 Effective date added...........................................26958 864.3875 (b) revised...............................................25045 Effective date added...........................................26958 864.4010 (b) revised...............................................25045 Effective date added...........................................26958 864.4400 (b) revised...............................................25045 [[Page 253]] Effective date added...........................................26958 864.5800 (b) revised...............................................25045 Effective date added...........................................26958 864.5850 (b) revised...............................................25045 Effective date added...........................................26958 864.6150 (b) revised...............................................25045 Effective date added...........................................26958 864.6160 (b) revised...............................................25045 Effective date added...........................................26958 864.6600 (b) revised...............................................25045 Effective date added...........................................26958 864.6700 (b) revised...............................................25045 Effective date added...........................................26958 864.8200 (b) revised...............................................25045 Effective date added...........................................26958 864.8540 (b) revised...............................................25045 Effective date added...........................................26958 866 Authority citation revised.....................................39641 866.9 Added........................................................25045 Effective date added...........................................26958 866.2050 (b) revised...............................................25045 Effective date added...........................................26958 866.2170 (b) revised...............................................25045 Effective date added...........................................26958 866.2300 (b) revised...............................................25046 Effective date added...........................................26958 866.2320 (b) revised...............................................25046 Effective date added...........................................26958 866.2330 (b) revised...............................................25046 Effective date added...........................................26958 866.2350 (b) revised...............................................25046 Effective date added...........................................26958 866.2360 (b) revised...............................................25046 Effective date added...........................................26958 866.2450 (b) revised...............................................25046 Effective date added...........................................26958 866.2480 (b) revised...............................................25046 Effective date added...........................................26958 866.2500 (b) revised...............................................25046 Effective date added...........................................26958 866.2560 (b) revised...............................................25046 Effective date added...........................................26958 866.2580 (b) revised...............................................25046 Effective date added...........................................26958 866.3010 (b) revised...............................................25046 Effective date added...........................................26958 866.3020 (b) revised...............................................25046 Effective date added...........................................26958 866.3035 (b) revised...............................................25046 Effective date added...........................................26958 866.3065 (b) revised...............................................25046 Effective date added...........................................26958 866.3125 (b) revised...............................................25046 Effective date added...........................................26958 866.3205 (b) revised...............................................25046 Effective date added...........................................26958 866.3250 (b) revised...............................................25046 Effective date added...........................................26958 866.3255 (b) revised...............................................25046 Effective date added...........................................26958 866.3270 (b) revised...............................................25046 Effective date added...........................................26958 866.3330 (b) revised...............................................25047 Effective date added...........................................26958 866.3340 (b) revised...............................................25047 Effective date added...........................................26958 866.3400 (b) revised...............................................25047 Effective date added...........................................26958 866.3410 (b) revised...............................................25047 Effective date added...........................................26958 866.3470 (b) revised...............................................25047 Effective date added...........................................26958 866.3490 (b) revised...............................................25047 Effective date added...........................................26958 866.3520 (b) revised...............................................25047 Effective date added...........................................26958 866.3630 (b) revised...............................................25047 Effective date added...........................................26958 866.3700 (b) revised...............................................25047 Effective date added...........................................26958 866.4500 (b) revised...............................................25047 Effective date added...........................................26958 866.4520 (b) revised...............................................25047 Effective date added...........................................26958 866.4540 (b) revised...............................................25047 Effective date added...........................................26958 866.4600 (b) revised...............................................25047 Effective date added...........................................26958 866.4830 (b) revised...............................................25047 Effective date added...........................................26958 866.4900 (b) revised...............................................25047 Effective date added...........................................26958 866.5800 (b) revised...............................................25047 Effective date added...........................................26958 868 Authority citation revised.....................................39641 868.9 Added........................................................25047 Effective date added...........................................26958 868.1030 (b) revised...............................................25048 Effective date added...........................................26958 868.1930 (b) revised...............................................25048 Effective date added...........................................26958 868.1965 (b) revised...............................................25048 Effective date added...........................................26958 868.2480 Added.....................................................27160 868.5220 (b) revised...............................................25048 Effective date added...........................................26958 868.5280 (b) revised...............................................25048 Effective date added...........................................26958 868.5365 (b) revised...............................................25048 Effective date added...........................................26958 868.5420 (b) revised...............................................25048 Effective date added...........................................26958 [[Page 254]] 868.5560 (b) revised...............................................25048 Effective date added...........................................26958 868.5760 (b) revised...............................................25048 Effective date added...........................................26958 868.6100 (b) revised...............................................25048 Effective date added...........................................26958 868.6175 (b) revised...............................................25048 Effective date added...........................................26958 868.6225 (b) revised...............................................25048 Effective date added...........................................26958 868.6700 (b) revised...............................................25049 Effective date added...........................................26958 870 Authority citation revised.....................................39641 870.9 Added........................................................25049 Effective date added...........................................26958 870.3730 (b) revised...............................................25049 Effective date added...........................................26958 870.4200 (b) revised...............................................25049 Effective date added...........................................26958 870.4500 (b) revised...............................................25049 Effective date added...........................................26958 872 Authority citation revised.....................................39641 872.9 Added........................................................13829 872.1730 (b) revised...............................................13830 872.1905 (b) revised...............................................13830 872.3080 (b) revised...............................................13830 872.3110 (b) revised...............................................13830 872.3140 (b) revised...............................................13830 872.3150 (b) revised...............................................13830 872.3220 (b) revised...............................................13830 872.3830 (b) revised...............................................13830 872.3840 (b) revised...............................................13830 872.3850 (b) revised...............................................13830 872.4565 (b) revised...............................................13830 872.6010 (b) revised...............................................13830 872.6050 (b) revised...............................................13830 872.6200 (b) revised...............................................13830 872.6290 (b) revised...............................................13831 872.6390 (b) revised...............................................13831 872.6570 (b) revised...............................................13831 872.6650 (b) revised...............................................13831 872.6670 (b) revised...............................................13831 872.6855 (b) revised...............................................13831 872.6870 (b) revised...............................................13831 872.6880 (b) revised...............................................13831 874 Authority citation revised.....................................39641 876 Authority citation revised.....................................39641 876.9 Added........................................................25049 Effective date added...........................................26958 876.4370 (b)(2) revised............................................25049 Effective date added...........................................26958 876.4530 (b) revised...............................................25049 Effective date added...........................................26958 876.4560 (b) revised...............................................25049 Effective date added...........................................26958 876.4730 (b) revised...............................................25049 Effective date added...........................................26958 876.4890 (b)(2) revised............................................25050 Effective date added...........................................26958 876.5030 (b) revised...............................................25050 Effective date added...........................................26958 876.5820 (b)(2) revised............................................25050 Effective date added...........................................26958 876.5900 (b) revised...............................................25050 Effective date added...........................................26958 876.5920 (b) revised...............................................25050 Effective date added...........................................26958 878 Authority citation revised.....................................39641 878.9 Added........................................................13827 (b) corrected................................................16438-T 878.1800 (b) revised...............................................13827 878.3250 (b) revised...............................................13827 878.3910 (b) revised...............................................13827 878.3925 (b) revised...............................................13827 878.4160 (b) revised...............................................13827 878.4800 (b) revised...............................................13827 878.4830 Added.....................................................50738 878.4950 (b) revised...............................................13828 878.5900 (b) revised...............................................13828 880 Authority citation revised.....................................39641 880.9 Added........................................................25050 Effective date added...........................................26958 880.5110 (b) revised...............................................25050 Effective date added...........................................26958 880.5120 (b) revised...............................................25050 Effective date added...........................................26958 880.5510 (b) revised...............................................25050 Effective date added...........................................26958 880.6150 (b) revised...............................................25050 Effective date added...........................................26958 880.6175 Removed...................................................47206 880.6250 (b) revised; eff. 4-13-89..................................1604 Technical correction............................................6804 880.6280 (b) revised...............................................25050 Effective date added...........................................26958 880.6970 (b) revised...............................................25050 Effective date added...........................................26958 882 Authority citation revised.....................................39641 882.9 Added........................................................25051 Effective date added...........................................26958 882.1200 (b) revised...............................................25051 Effective date added...........................................26958 882.1500 (b) revised...............................................25051 Effective date added...........................................26958 882.1525 (b) revised...............................................25051 Effective date added...........................................26958 882.1700 (b) revised...............................................25051 Effective date added...........................................26958 882.1750 (b) revised...............................................25051 Effective date added...........................................26958 882.4215 (b) revised...............................................25051 Effective date added...........................................26958 [[Page 255]] 882.4650 (b) revised...............................................25051 Effective date added...........................................26958 884 Authority citation revised.....................................39641 884.9 Added........................................................25051 Effective date added...........................................26958 884.2900 (b) revised...............................................25052 Effective date added...........................................26958 884.4520 (b) revised...............................................25052 Effective date added...........................................26958 884.5920 (b) revised...............................................25052 Effective date added...........................................26958 886 Authority citation revised.....................................39641 888 Authority citation revised.....................................39641 888.3353 Added.....................................................48239 (a) corrected..................................................51342 890 Authority citation revised.....................................39641 890.9 Added........................................................25052 Effective date added...........................................26958 890.3700 (b) revised...............................................25052 Effective date added...........................................26958 890.5125 (b) revised...............................................25052 Effective date added...........................................26958 892 Authority citation corrected....................................6804 Authority citation revised.....................................39641 892.9 Added........................................................13831 892.1000 Added......................................................5078 892.1370 (b) revised...............................................13832 892.1380 (b) revised...............................................13832 892.1400 (b) revised...............................................13832 892.1420 (b) revised...............................................13832 895 Authority citation revised.....................................39641 895.101 Authority citation removed.................................39641 1000 Authority citation revised....................................39642 1000.50 Authority citation removed.................................39641 1002 Authority citation revised; sectional authority citations removed....................................................39642 1003 Authority citation revised; sectional authority citations removed....................................................39642 1004 Authority citation revised....................................39642 1005 Authority citation revised; sectional authority citations removed....................................................39642 1010 Authority citation revised; sectional authority citations removed....................................................39642 1020 Authority citation revised....................................39642 1020.33 Authority citation removed.................................39642 1030 Authority citation revised....................................39642 1040 Authority citation revised....................................39642 1040.30 Authority citation removed.................................39642 1050 Authority citation revised....................................39642 1210 Authority citation revised....................................39642 1220 Authority citation revised....................................39642 1220.40 Authority citation removed.................................39642 1230 Authority citation revised....................................39642 1240 Cross-references revised......................................24900 Authority citation revised.....................................39642 1240.10 (f) amended................................................24900 1240.62 (c)(1)(i) through (v) and (2) amended......................24900 1240.70 (a) revised................................................24900 1250 Cross-references revised......................................24900 Authority citation revised.....................................39642 1250.51 (d), (f)(1), (2), (3) introductory text, and (4)(i) and (iii) amended..............................................24900 Chapter II 1301.74 (g) amended................................................33674 1301.75 (d) amended................................................33674 1306.06 (b) amended................................................33674 1306.13 (d) amended................................................33674 1305.16 (a) and (b)(1) amended.....................................33674 1308.11 (g) (3) and (4) removed; (d) (8) through (25) and (g) (5) and (6) redesignated as (d) (10) through (27) and (g) (3) and (4); (d) (8) and (9) added.............................14798 (g)(3) removed; (f)(2) and (g)(4) redesignated as (f)(3) and (g)(3); new (f)(2) added...........................................14800 (d)(28) added..................................................28415 (g) temporary scheduling extended..............................31815 1308.22 Table amended...............................................2100 Table revised..................................................12162 1308.24 (i) table revised; interim.................................10633 1308.32 Table revised; interim.....................................11520 1310 Revised.......................................................31662 1313 Added.........................................................31665 Policy statement...............................................49750 1316 Authority citation revised....................................37610 1316.21--1316.22 (Subpart B) Authority citation revised............31670 [[Page 256]] 1316.21 Redesignated as 1316.23; new 1316.21 added.................31670 1316.22 Redesignated as 1316.24; new 1316.22 added.................31670 1316.23 Redesignated from 1316.21..................................31670 1316.24 Redesignated from 1316.22..................................31670 1316.90--1316.99 (Subpart F) Added.................................37610 1990 21 CFR 55 FR Page Chapter I Chapter I Uniform compliance date 1-1-93.............................276 2.125 (e)(12) added................................................39267 5 Authority citation revised........................................9078 Authority citation corrected...................................14916 5.22 (a)(12)(v) added...............................................6247 (a)(9)(iii) and (iv) revised...................................47053 5.23 (c)(2) and (3) revised........................................47053 5.31 (f)(3) revised.................................................6247 (a)(2)(iv) added...............................................51688 5.37 (a)(2)(ii), (iii), (b)(2) and (3) revised; (b)(4) redesignated as (b)(5); new (b)(4) added...................47053 5.45 (b) introductory text, (4), (c)(2) and (e)(1)(ii) revised; (e)(1)(iii) and (iv) redesignated as (e)(1)(iv) and (v); new (e)(1)(iii) added......................................47053 5.46 Revised.......................................................47053 5.47 (a)(2) revised................................................47053 5.51 Added..........................................................6794 5.58 (c)(1)(iv) added..............................................51688 5.59 (a)(1) and (b) revised........................................47053 5.71 (b)(2) and (c)(2) revised.....................................51688 5.72 Added..........................................................5445 5.80 (c)(1)(i) and (ii) revised; (c)(1)(iii) added..................6247 (a)(1)(iii) added..............................................51688 5.86 (b) revised...................................................47053 5.87 (b) revised...................................................47053 5.88 Revised.......................................................47054 5.89 (a) introductory text and (b) introductory text revised.......47054 5.91 Revised.......................................................47054 5.93 (b) revised....................................................6247 5.94 (b)(4) added..................................................51688 5.100 Revised.......................................................9418 5.115 Revised.......................................................9419 7 Authority citation revised........................................9079 10 Authority citation revised.......................................9079 12 Authority citation revised.......................................9079 13 Authority citation revised.......................................9079 14 Authority citation revised.......................................9079 14.7 (b) removed....................................................1404 14.31 (e) amended..................................................42703 14.40 (b) amended..................................................42703 14.100 (c)(16) added................................................5838 (b)(2)(ii), (c)(11)(i) and (d)(2)(i) amended; (c)(2)(ii) and (e)(2) revised......................................................7316 (d)(1)(i)(B), (ii)(B), (iii)(B), (iv)(B), (v)(B), (vi)(B), (vii)(B), (viii)(B), (ix)(B), (x)(B), (xi)(B), (xii)(B), (xiii)(B), (xiv)(B), (xv)(B), and (xvi)(B) amended.................42703 (d)(1) revised.................................................51282 15 Authority citation revised.......................................9079 16 Authority citation revised.......................................9079 19.10 (a) amended...................................................1404 20 Authority citation revised.......................................9079 20.41 (b)(4) amended................................................1405 20.47 (c) amended...................................................1405 25 Authority citation revised.......................................9079 50.23 (d) added; interim...........................................52817 73.3106 Added......................................................30214 Technical correction...........................................33816 Regulation at 55 FR 30214 effective date confirmed.............46044 74.1602 (c) revised................................................18868 (c)(2)(i) amended..............................................12172 Regulation at 55 FR 12172 eff. date confirmed..................26430 74.3045 (c)(1) introductory text revised...........................19620 Effective date confirmed.......................................31824 Effective date corrected.......................................21674 74.3230 Added......................................................22898 Regulation at 55 FR 22898 eff. date confirmed..................37868 74.3602 (b)(2) revised; (b)(3) and (4) added.......................18868 Effective date confirmed.......................................31823 81.1 (a) table amended..............................................3519 81.10 (u) added.....................................................3519 81.27 Removed.......................................................3519 81.30 (u) added.....................................................3519 82.303 Removed......................................................3519 101.4 (a) redesignated as (a)(1); (a)(2) added.....................17433 102.47 Revised.....................................................45797 109 Subpart C heading redesignated as Subpart D; new Subpart C heading added..............................................20785 Subpart D heading redesignated from Subpart C..................20785 [[Page 257]] 109.4 (c) redesignated as (d); heading, (b), and new (d) revised; new (c) added..............................................20785 109.6 (c) and (d) redesignated as (d) and (e); (a), new (d) and (e) revised; new (c) added.................................20785 109.7 (b) revised..................................................20785 109.8 Removed......................................................20786 133 Effective date confirmed........................................2510 Technical correction............................................6876 133.127 (a) amended................................................51409 133.138 (b)(3)(iv) revised eff. 4-30-90.............................6795 Regulation at 55 FR 6795 confirmed.............................48107 133.195 (b)(3)(iv) revised eff. 4-30-90.............................6795 Regulation at 55 FR 6795 confirmed.............................48107 133.196 Revised eff. 4-30-90........................................6795 Regulation at 55 FR 6795 confirmed.............................48107 161.190 (a)(2), (4)(i) and (8)(vi) revised; (a)(6)(ix) added.......45797 168.122 (b)(1) and (3), and (d) revised eff. 4-10-90................8459 Regulation at 55 FR 8458 effective date confirmed..............28019 172.665 Added......................................................39614 173.310 (c) table amended..........................................12172 173.342 Added.......................................................8913 173.357 (a)(2) table amended.......................................12172 175.105 (c)(5) table amended................................10235, 30215 176.170 (a)(5) table amended.................................1673, 10236 (b)(2) table amended...........................................13520 176.300 (c) table amended..........................................31825 177.1210 (b)(5) table amended......................................34555 177.1350 (a)(6) added..............................................18595 177.1520 (b) table amended.........................................18596 (c) table amended..............................................31826 (b) table corrected............................................19701 (b) table amended..............................................34710 177.1635 (e) revised...............................................52989 177.2550 (d)(1) revised; (d)(2) and (3) redesignated as (d)(3) and (4); (a)(4) and new (d)(2) added............................8139 177.2600 (c)(4)(i) amended.........................................34555 178 Technical correction...........................................50279 178.1005 (e)(1) table amended......................................47055 178.2010 (b) table amended....................13521, 18597, 22901, 30216 178.3280 (b) table amended..........................................8914 178.3295 Table amended.............................................52990 178.3297 (e) table amended.....................3585, 12344, 18721, 31827 178.3570 (a)(3) table amended...............................30218, 47323 178.3700 (a) and (d) amended.......................................12172 178.3770 Heading, introductory text, (a) introductory text, (b) introductory text, (c) introductory text and (c)(1) amended; (d) added.........................................28020 179 Authority citation revised......................................9079 179.26 (c)(4) removed..............................................14415 (c)(4) correctly removed.......................................18227 (b) Table revised..............................................18544 Technical correction...........................................19701 182.3616 (c) revised; eff. 4-16-90..................................9832 182.3637 (c) revised; eff. 4-16-90..................................9832 182.3739 (c) revised; eff. 4-16-90..................................9832 182.3766 (c) revised; eff. 4-16-90..................................9833 182.3798 (c) revised; eff. 4-16-90..................................9833 182.3862 (c) revised; eff. 4-16-90..................................9833 184.1498 Added......................................................6391 Technical correction...........................................10030 184.1685 Revised...................................................10935 200.10 (c) amended.................................................11576 201.57 (b)(2)(ii), (c)(2), (3)(i) and (v), (f)(9), (g)(2) and (4), and (m)(1) amended.........................................11576 201.58 Revised.....................................................11576 201.59 (a)(2) and (3) amended......................................11576 201.63 (e) added...................................................27784 201.122 (b) amended................................................11576 201.200 (d) amended................................................11576 201.305 (d)(2) amended.............................................11576 201.306 (a)(2) amended.............................................11576 201.307 (c)(3) amended.............................................11576 205 Added..........................................................38023 207.3 (a)(5) amended...............................................11576 207.7 (a) and (d) amended..........................................11576 207.20 (c) amended.................................................11576 207.21 (a) amended.................................................11576 207.22 (a) and (b) amended.........................................11576 207.25 (b)(2) amended..............................................11577 207.26 Amended.....................................................11577 207.35 (b)(3)(v) amended...........................................11577 207.37 Introductory text and (b) amended...........................11577 207.40 (b) amended.................................................11577 211.176 Amended....................................................11577 211.194 (a)(2) footnote amended....................................11577 225.58 (b)(1) amended..............................................11577 226.58 (e) footnote amended........................................11577 (d) amended....................................................23703 250.10 (c) revised.................................................11577 250.103 (d) revised................................................11577 250.106 (c) revised................................................11577 [[Page 258]] 250.250 (c)(4) introductory text, (ii), and (v) amended............11577 299.4 (b) and (d) amended..........................................11577 300 Authority citation correctly added.............................14968 310.6 (e) amended..................................................11578 310.103 (b) revised................................................11578 310.201 (a)(23)(v)(b) removed; eff. 8-5-91.........................31779 310.305 (c)(2), (d)(3)(ii), and (4) amended........................11578 310.500 (a)(1) introductory text and (vii) introductory text, (d), (f), (h) introductory text, (h)(3)(iv) amended.............11578 310.502 (a)(2) and (b)(4) amended..................................11578 310.503 (a), (d)(3), (e), (f)(3), (5)(i) and (ii) amended..........11578 310.504 (f) amended................................................11578 310.506 (c) revised................................................11578 310.507 (c) revised................................................11578 310.508 (c) revised................................................11578 310.509 (a), (b), (e), and (i) amended.............................11578 310.510 (c) revised................................................11579 310.513 (c)(3), (d), and (e) amended...............................11579 310.515 (g) amended................................................11579 Revised........................................................18723 310.519 (c) revised................................................11579 310.525 (c) revised................................................11579 310.526 (c) revised................................................11579 310.529 (c) revised................................................11579 310.532 Added; eff. 8-27-90.........................................6930 310.533 (c) revised................................................11579 310.534 (c) revised................................................11579 310.541 Added......................................................19858 310.542 Added......................................................19858 310.545 Added; eff. 5-7-91.........................................46919 (a)(7) corrected...............................................49973 312 Technical correction....................................50279, 51799 312.32 (c)(1) redesignated as (c)(1)(i); new (c)(1)(i), (2), and (3) amended................................................11579 312.36 Amended.....................................................11579 312.44 (d) amended.................................................11579 312.47 (b)(1)(iv) and (v) amended..................................11580 312.48 (b) and (c)(1) amended......................................11580 312.57 (c) added; interim..........................................47038 312.140 (a), (b), and (c) amended..................................11580 312.145 (b) revised................................................11580 314 Technical correction.............................37322, 50279, 51799 314.50 (f)(1) revised..............................................11580 314.80 (f)(3) and (4) amended......................................11580 314.81 (a) amended.................................................11580 314.106 (a) amended................................................11580 314.110 (c) amended................................................11580 314.120 (c) amended................................................11580 314.125 (b)(17) added; interim.....................................47038 314.126 (c) amended................................................11580 314.150 (b)(1) amended.............................................11580 (b)(9) added...................................................47038 314.200 (a) introductory text, (3), (f), (g)(2), and (3) amended 11580 314.300 (b)(7), (8)(ii) and (iii) amended..........................11580 314.420 (a)(1) through (5) revised.................................28380 314.430 (b), (e)(2)(ii)(a) and (b), (f)(5) and (6) amended.........11580 314.440 (a) introductory text, (1), (2), (3) amended; (b) introductory text revised..................................11581 314.445 (b) revised................................................11581 320 Technical correction....................................50279, 51799 320.30 (c) amended.................................................11581 320.31 Heading revised; (a) introductory text, (c), (d), and (f) amended....................................................11581 (a) introductory text, (c) and (d) revised; (e) and (f) removed; interim...................................................47038 320.32 Added; interim..............................................47038 (c) corrected..................................................50279 (a) and (c) corrected; interim.................................52991 320.63 Added; interim..............................................47038 329.20 (d) amended.................................................11581 330.1 (f) amended..................................................11581 330.10 (a)(4)(ii) amended..........................................11581 330.11 Amended.....................................................11581 330.13 (d)(2)(i) amended...........................................11581 331.11 (a)(1) and (4) revised; eff. 5-13-91........................19859 331.22 Amended.....................................................11581 331.30 (g) amended.................................................11581 331.31 Redesignated as 331.80 and new (a)(3) and (4) added; eff. 5-13-91....................................................19859 331.80 Redesignated from 331.31 and new (a)(3) and (4) added; eff. 5-13-91....................................................19859 333.120 (b)(3) added; eff. 3-15-91..................................9722 (a)(7) revised; eff. 10-3-91...................................40381 (a)(5)(iii) redesignated as (a)(5)(iv); new (a)(5)(iii), (b)(4), (5) and (6) added; eff. 12-5-91............................50172 338 Authority citation revised......................................9079 341.3 (b) and (c) revised..........................................40382 [[Page 259]] 341.74 (f) added...................................................27808 (d)(2)(iii) revised............................................40383 346 Added; eff. 8-5-91.............................................31779 357.801--357.850 (Subpart I) Added; eff. 5-13-91...................19865 358 Added..........................................................33255 Regulation at 55 FR 33255; effective date corrected to 8-14-91 37403 358.150 (c)(1)(ii) and (d)(3) corrected............................37403 358.501--358.550 (Subpart F) Added; eff. 8-14-91...................33261 361.1 (b)(2), (c)(1), (3), (4), (d)(8) and (e) amended.............11582 369.20 Amended; eff. 8-5-91........................................31783 369.21 Amended.....................................................11582 429.40 (a) amended.................................................11582 430 Authority citation corrected...................................11110 430.4 (a)(61) added.................................................2641 (a)(62) added...................................................6634 (a)(63) added..................................................14240 430.5 (a)(96) and (b)(98) added.....................................2641 (a)(97) and (b)(99) added.......................................6634 (a)(98) and (b)(100) added.....................................14240 430.6 (b)(98) added.................................................2641 (b)(99) added...................................................6634 (b)(100) added.................................................14240 431.1 (a) amended..................................................11582 431.50 Amended.....................................................11582 431.51 (d) amended.................................................11582 431.53 (h) amended.................................................11582 433.17 Amended.....................................................11582 436.212 (e)(5) added; (f) revised..................................19873 436.215 (b) table amended; (c)(12) added............................6636 440.1a (a)(3)(ii) introductoryt text amended.......................11582 440.2a (a)(3)(ii) introductory text amended........................11582 440.80 Added.......................................................38674 440.91 Added........................................................5839 440.103d (a)(3)(ii) introductory text amended......................11582 440.103e (a)(3)(ii) introductory text amended......................11582 440.103f (a)(3)(ii) introductory text amended......................11582 440.209b (a)(3)(ii) introductory text amended......................11582 440.241 Redesignated as 440.241a; new 440.241 added..................277 440.241a Redesignated from 440.241...................................277 440.241b Added.......................................................277 440.249 Redesignated as 440.249a; new 440.249 added..................279 (b) introductory text corrected.................................2481 440.249a Redesignated from 440.249...................................279 440.249b Added.......................................................279 440.280c Added.....................................................38675 440.290b (a)(3)(ii) introductory text amended......................11582 440.290c Added......................................................5840 441.20a (a)(3)(ii) introductory text amended.......................11582 441.220 (a)(3)(ii) introductory text amended.......................11582 442.10 (a)(3)(ii) amended..........................................11582 442.12 (a)(3)(ii) amended..........................................11583 442.12a (a)(3)(ii) amended.........................................11583 442.13 (a)(3)(ii) amended..........................................11583 442.14 (a)(3)(ii) amended..........................................11583 442.16a (a)(3)(ii) amended.........................................11583 442.17 (a)(3)(ii) amended..........................................11583 442.17a (a)(3)(ii) amended.........................................11583 442.18a (a)(3)(ii) introductory text amended.......................11583 442.19 (a)(3)(ii) amended..........................................11583 442.20a (a)(3)(ii) introductory text amended.......................11583 442.50a (a)(3)(ii) introductory text amended.......................11583 442.53a (a)(3)(ii) introductory text amended.......................11583 Technical correction...........................................24026 442.55 (a)(2)(ii) amended..........................................11583 442.55a (a)(3)(ii) introductory text amended.......................11583 442.60 Added.......................................................14240 442.70a Added.......................................................6634 442.119 (a)(3)(ii) introductory text amended.......................11583 442.211b (a)(3)(ii) introductory text amended......................11583 442.212b (a)(3)(ii) introductory text amended......................11583 442.213b (a)(3)(ii) introductory text amended......................11583 442.214b (a)(3)(ii) introductory text amended......................11583 442.216a (a)(3)(ii) introductory text amended......................11583 442.217b (a)(3)(ii) introductory text amended......................11583 442.223 Amended....................................................11583 442.250 (a)(3)(ii) introductory text amended.......................11583 [[Page 260]] 442.255b (a)(3)(ii) introductory text amended......................11583 442.260 Added......................................................14242 442.270a Added......................................................6636 444.7 Added........................................................38676 444.46 (a)(3)(ii) amended..........................................11584 444.206 (a)(1) amended.............................................38677 444.246 (a)(3)(ii) introductory text amended.......................11584 444.320d Added......................................................2643 444.342h (a)(1) amended............................................14969 444.342i (a)(1)(ii) amended........................................14969 444.342j (a)(1) amended............................................14969 444.342k (a)(1) amended............................................14969 444.380d Added.......................................................617 444.442g (a)(1) amended............................................18598 444.542k (a)(3)(ii) introductory text amended......................11584 444.542l (a)(3)(ii) introductory text amended......................11584 (a)(1) revised; eff. 12-5-91...................................50173 446.120d (a)(3)(ii) introductory text amended......................11584 446.121 Redesignated as 446.121a; new 446.121 added.................6637 446.121a Redesignated from 446.121..................................6637 446.121b Added......................................................6637 448.23 (a)(3)(ii) amended..........................................11584 448.123 (a)(3)(ii) introductory text amended.......................11584 Redesignated as 448.123a; new 448.123 added....................19873 448.123a Redesignated from 448.123.................................19873 448.123b Added.....................................................19873 (b)(1)(ii) corrected...........................................22014 448.223 (a)(3)(ii) introductory text amended.......................11584 448.510f (a)(1) revised; eff. 3-15-91...............................9722 (a)(3)(ii) introductory text amended...........................11584 448.513a (a)(1) revised; eff. 12-5-91..............................50173 448.513c (a)(1) revised; eff. 12-5-91..............................50173 448.513d (a)(3)(ii) introductory text amended......................11584 448.513e (a)(1) revised; eff. 10-3-91..............................40381 (a)(3)(ii) introductory text amended...........................11584 449.150d (a)(3)(ii) introductory text amended......................11584 Technical correction...........................................24026 452.32a (a)(3)(ii) introductory text amended.......................11584 452.110d (a)(3)(ii) introductory text amended......................11584 452.115g Added.......................................................280 Technical correction............................................2481 452.125d (b)(1) revised............................................14091 452.510d (a)(3)(ii) introductory text amended......................11584 452.910 (a)(3)(ii) amended.........................................11584 (a)(4)(ii) correctly amended............................23634, 25392 453.222 (a)(1) revised..............................................5842 Technical correction...........................................11109 455.4a (a)(3)(ii) introductory text amended........................11584 455.15 (a)(3)(ii) amended..........................................11584 455.15a (a)(3)(ii) amended.........................................11584 455.40 Added........................................................2641 (a)(1) introductory text, (a)(1)(iii) and (b)(2) corrected.....11110 (a)(1) introductory text corrected.............................14378 455.82a (a)(3)(ii) amended.........................................11585 455.185b (a)(3)(ii) introductory text amended......................11585 455.204a Corrected..................................................9317 (a)(3)(ii) introductory text amended...........................11585 455.510d (a)(1) amended............................................11585 455.540 Added.......................................................2642 509 Subpart C heading redesignated as Subpart D; new Subpart C heading added..............................................20786 Subpart D heading redesignated from Subpart C..................20786 509.4 (c) redesignated as (d); heading, (b), and new (d) revised; new (c) added..............................................20786 509.6 (c) and (d) redesignated as (d) and (e); (a), new (d) and (e) revised; new (c) added.................................20786 509.7 (b) revised..................................................20786 509.8 Removed......................................................20787 510.450 Removed....................................................32396 510.600 (c)(1) table and (2) table amended.........................1405, 1673, 8460, 8461, 13902, 14830, 17952, 18330, 19874, 23703, 24226, 25301, 25971, 26683, 29842, 30214, 32616, 37226, 39615, 39616, 45798, 51409 514.2 (d) added....................................................14831 514.9 Interpretative rule..........................................25972 514.106 Added......................................................46052 (b)(2)(iii) corrected..........................................49973 [[Page 261]] 520.48 (c)(1) and (3) amended......................................26431 520.260 (b)(2) amended.............................................24556 520.540 (b)(2) amended..............................................8461 520.580 (b)(1) amended.............................................39616 520.622a (a)(3) amended.............................................8461 520.622c (b)(4) amended.............................................8462 (b)(3) amended.................................................32616 520.812 (c)(3) amended.............................................24226 (c)(2) redesignated as (c)(2)(i); (c)(2)(ii) added; (c)(3) revised............................................................43327 520.1263c (d) revised...............................................3209 520.1445 Added.....................................................25301 (c)(3) corrected...............................................49888 520.1448 Amended....................................................3586 520.1630 Revised...................................................46943 520.1720a (b)(3) amended............................................8462 520.1720d (b) amended...............................................8462 520.1870 Nomenclature change; (c)(1)(i), (iii), and (2)(iii) revised.....................................................2234 520.2080a Removed..................................................24556 520.2087 (b) amended................................................8460 520.2088 (a)(2) and (b)(2) amended..................................8460 520.2150a (b) amended..............................................23076 520.2150b (b) amended..............................................23076 520.2184 (b) amended................................................8460 520.2260b (c)(1) and (e)(1) amended.................................8462 520.2320 (c) amended................................................8460 520.2325a (c)(1) amended...........................................29843 520.2325b (c) amended..............................................29843 522 Technical correction...........................................36751 522.144 (c) revised................................................26683 522.313 (d)(1)(i) amended..........................................13768 522.540 (d)(2)(i) and (e)(2) amended................................8462 (d)(2)(ii) amended.............................................13902 522.812 Added......................................................26683 522.1079 Added......................................................1405 522.1183 (e)(1) amended.............................................8462 (f) removed....................................................33670 522.1192 (d)(4)(ii) correctly added.................................3586 522.1193 Added.....................................................38984 522.1225 Added.....................................................40653 522.1228 Removed...................................................33670 522.1290 Added......................................................1185 522.1372 (b) amended...............................................23076 522.1662a (i)(2) amended............................................8462 522.1680 (b) amended................................................8462 522.1698 (b) amended...............................................23076 522.1720 (b)(1) amended.............................................8462 (b)(1) amended.................................................13902 522.1880 (b) amended...............................................13902 522.1940 (a) removed; (b) and (d)(1)(iii) revised..................13769 522.2150 (b) amended...............................................23076 522.2662 (b) revised...............................................18724 (b) amended....................................................32616 522.2670 (b) amended...............................................32616 524 Technical correction.............................................797 524.1193 Added.....................................................50551 524.1580b (b) amended...............................................8462 (b) revised....................................................20455 524.1580d (b) amended...............................................8462 529.2090 (b) correctly amended.....................................31481 (c) amended....................................................29842 540.181b (c)(2) amended.............................................8460 540.255a Removed...................................................25973 540.874a (c)(3)(i) and (4)(i) amended...............................8462 544.275 (c)(2) amended.............................................13902 555.110a (c)(2)(ii) amended.........................................8462 555.210 (c)(2) amended..............................................8462 556.360 Revised.....................................................3209 556.495 Added......................................................46943 558 Technical correction...........................................37287 558.4 (d) table amended........................1406, 18599, 23424, 46513 558.15 (g)(1) table amended.........................................8462 (g)(2) table amended............................................8460 558.35 (a) amended..................................................8460 558.55 (d)(2) table amended.........................................8460 558.58 (d)(1) table amended.........................................8460 558.95 (b)(1)(iii)(b), (iv)(b), (v)(b), (vii)(b), (ix)(b), (x)(b), and (xi)(b) amended.........................................8460 558.105 (d)(1)(ix)(b) amended.......................................8460 558.195 (d) table amended...........................................8460 558.258 (c)(1)(i) and (ii) revised.................................48231 558.274 (a)(4) and (c)(1) table amended............................25972 558.311 (e)(1) table amended........................................8460 Correctly designated............................................3685 Corrected.......................................................5446 Technical correction...........................................15099 (e)(1) table amended; (e)(3) added.............................31828 558.325 (c)(2)(i)(b), (ii)(b), and (v)(b) amended..................23424 (c)(2)(v)(b) corrected.........................................25202 (c)(2)(ii)(b) corrected........................................34011 558.340 (c)(2)(ii) amended............................................23 (c)(4)(ii) amended..............................................8460 (c)(3) and (4) removed.........................................49616 558.342 (a), (c)(1)(ii), (2) introductory text, (ii), (3) introductory text, and (ii) revised; (c)(4) through (6) added......................................................31828 (c)(4)(ii) corrected...........................................34007 558.355 (a) revised.................................................3586 [[Page 262]] (f)(1)(x)(b), (xi)(b), (xii)(b), (xv)(b), (xvi)(b), (xviii)(b), (xix)(b), (xx)(b), and (xxiii)(b) amended...............8460 (f)(2)(iii) revised............................................11012 (f) (3)(iv) revised............................................31829 (b)(4) through (9), (11), and (12) revised.....................42704 (f)(3)(vii) added..............................................43328 558.363 (c)(1)(V)(B) amended........................................8460 558.369 (a) amended.................................................8460 558.376 (a) amended.................................................8460 558.430 (a) amended.................................................8461 558.450 (d)(1) Table 1 amended.....................................17599 558.485 (e) introductory text amended; (e)(1) introductory text through (12)(iii) redesignated as (e)(1)(i) through (xii)(C); new (e)(1) introductory text and (2) added; (a)(1) through (23), (25), (27), new (e)(1)(x)(B) and (xi)(B) revised............................................18599 (a)(14) removed................................................30215 558.515 (d)(1)(ii)(b) amended.......................................8461 558.530 (a)(2) amended..............................................8461 558.550 (b)(1)(ii)(c), (iv)(c), (v)(c), (ix)(c), (xii)(c), (xiv)(c), (xv)(c) amended...................................8461 (b)(3)(iii) added..............................................17599 558.586 (a) amended................................................29843 558.625 (b)(39) amended.............................................8462 (b)(20) removed................................................17952 (b)(47) and (75) removed.......................................18330 (b)(46) removed................................................24226 (b)(69) removed................................................25972 (b)(49) and (56) removed.......................................30215 (f)(2)(ii) added...............................................31829 (b)(26) and (86) removed.......................................39615 (b)(82) removed................................................39616 558.630 (b)(10) amended............................................25972 (b)(8) amended.................................................30215 (b)(10) amended.........................................39615, 39616 558.680 (a) amended.................................................8461 600.3 (d) revised..................................................11014 600.10 (a) nomenclature change.....................................11014 600.11 (f)(6) nomenclature change..................................11013 600.12 (b)(2) and (3) nomenclature change..........................11013 600.13 Nomenclature change.........................................11013 600.14 (a) amended.................................................11014 600.15 (b) nomenclature change.....................................11013 600.22 (e) nomenclature change.....................................11013 601.2 (a) nomenclature change......................................11013 (b) amended....................................................11014 601.3 (a) introductory text and (b) introductory text nomenclature change.....................................................11013 601.4 (a) nomenclature change......................................11013 601.6 (a)(2) nomenclature change...................................11013 601.9 (a) nomenclature change......................................11013 601.12 (a) and (b) nomenclature change.............................11013 601.21 Amended.....................................................11014 601.25 (b)(2) amended..............................................11014 601.31 Nomenclature change.........................................11013 601.33 Nomenclature change.........................................11013 601.51 (b) nomenclature change.....................................11013 606.20 (a) nomenclature change.....................................11014 606.100 (a) and (d)(3) nomenclature change.........................11013 606.110 (b) nomenclature change....................................11013 606.121 (c)(13), (d) introductory text, (4), and (5) nomenclature change.....................................................11014 606.170 (b) nomenclature change....................................11014 607.3 (e) nomenclature change......................................11014 607.7 (b) and (c) nomenclature change..............................11014 607.22 (a) and (b) nomenclature change.............................11014 607.25 (b)(2) nomenclature change..................................11013 607.37 (a) introductory text and (b) amended.......................11014 607.40 (b) nomenclature change.....................................11014 610.2 (a) nomenclature change......................................11013 (b) amended....................................................11014 610.9 (b) nomenclature change......................................11014 610.11 (c)(2) and (3) nomenclature change..........................11013 610.12 (e)(2)(i) and (g)(4)(ii) nomenclature change................11013 610.13 (a) revised; OMB control number.............................28381 610.15 (a)(3) nomenclature change..................................11013 610.18 (c)(2) nomenclature change..................................11013 610.20 Introductory text nomenclature change.......................11013 610.40 (a) and (e)(2) nomenclature change..........................11013 [[Page 263]] (b)(4), (d)(1)(v) and (2)(iv) amended..........................11014 610.53 (d) nomenclature change.....................................11014 610.61 (s) removed; (t) redesignated as (s)........................10423 Technical correction...........................................14037 620.6 (h) introductory text nomenclature change....................11013 620.12 Introductory text amended...................................11015 620.13 (h) nomenclature change.....................................11013 620.14 (c)(2) and (3) nomenclature change..........................11013 (c) introductory text amended..................................11015 620.21 (b) nomenclature change.....................................11013 620.22 Nomenclature change.........................................11013 620.24 (c) introductory text, (1), and (3) nomenclature change.....11013 620.31 (a)(1) nomenclature change..................................11013 620.32 Introductory text nomenclature change.......................11013 620.35 (e) introductory text, (2), and (3) nomenclature change.....11013 620.43 Nomenclature change.........................................11013 620.44 (c) nomenclature change.....................................11013 620.45 (b) introductory text, (1), (4), and (5) nomenclature change.....................................................11013 620.48 (a) introductory text, (a)(2) and (b) nomenclature change 11013 630 Authority citation revised.....................................47875 Technical correction...........................................50279 630.1 (b) and (c) nomenclature change..............................11013 630.2 (c) nomenclature change......................................11013 630.3 Introductory text and (a) nomenclature change................11013 630.4 (e)(1) and (3) nomenclature change...........................11013 630.5 (c) introductory text and (4) nomenclature change............11013 630.10 (a), (b)(2), (4), (5), and (6) nomenclature change..........11013 630.12 (a)(1) and (b) nomenclature change..........................11013 630.14 Nomenclature change.........................................11013 630.17 (e) introductory text and (1) nomenclature change...........11013 630.30 (c)(1)(iii) nomenclature change.............................11013 (c)(1) introductory text revised...............................47875 630.31 Revised.....................................................47875 630.33 Nomenclature change.........................................11013 630.36 (h) introductory text and (1)(i) nomenclature change........11013 630.50 (c)(1)(ii) nomenclature change..............................11013 (c)(1) introductory text revised...............................47875 630.53 Nomenclature change.........................................11013 630.55 (a)(4) revised..............................................47876 630.56 (f) introductory text and (1) nomenclature change...........11013 630.60 (d)(3) and (e)(1)(ii) nomenclature change...................11013 (e)(1) introductory text revised...............................47876 630.62 (a) revised.................................................47876 630.63 Nomenclature change.........................................11013 630.66 (e) introductory text, (1)(i), and (3) nomenclature change 11013 630.70 (b) nomenclature change.....................................11013 630.72 Nomenclature change.........................................11013 630.74 (c) nomenclature change.....................................11013 630.75 (d)(1), (i) and (2) nomenclature change.....................11013 630.80--630.86 (Subpart I) Removed.................................47876 630.81 Nomenclature change.........................................11013 630.83 Nomenclature change.........................................11013 630.86 (e) introductory text, (1)(i), and (3) nomenclature change 11013 640.2 (a) nomenclature change......................................11013 640.3 (a)(1) nomenclature change...................................11013 640.4 (a)(1) nomenclature change...................................11013 640.6 Introductory text nomenclature change........................11013 640.17 Nomenclature change.........................................11013 640.21 (c) nomenclature change.....................................11013 640.22 (c) nomenclature change.....................................11013 640.25 (c) introductory text and (3) nomenclature change...........11013 640.55 Nomenclature change.........................................11013 640.56 (c) introductory text and (2) nomenclature change...........11013 640.64 (c) introductory text nomenclature change...................11013 640.66 Nomenclature change.........................................11013 [[Page 264]] 640.71 (b)(3) nomenclature change..................................11013 640.73 Nomenclature change.........................................11013 640.74 (a) and (b)(2) nomenclature change..........................11013 640.75 Removed.....................................................10423 Technical correction...........................................14037 640.82 (b) nomenclature change.....................................11013 640.92 (b) nomenclature change.....................................11013 640.101 (f) introductory text nomenclature change..................11013 640.104 (c) introductory text nomenclature change..................11013 640.111 (g) introductory text nomenclature change..................11013 640.112 (b) nomenclature change....................................11013 640.120 (Subpart L) Added..........................................10423 Technical correction...........................................14037 650.6 Introductory text, (a), and (c) nomenclature change..........11013 650.11 (c) introductory text, (1), and (5) nomenclature change.....11013 660.3 Nomenclature change..........................................11013 660.5 Nomenclature change..........................................11013 660.6 (a)(2) introductory text and (iii), (b), (c)(1), (2), and (3) nomenclature change....................................11013 660.33 Nomenclature change.........................................11013 660.34 (d) nomenclature change.....................................11013 660.36 (a)(1), (b), and (c) nomenclature change....................11013 (a) introductory text amended..................................11015 660.42 Nomenclature change.........................................11013 660.44 Nomenclature change.........................................11013 660.46 (a)(2) introductory text and (iii), (b), (c)(1), (2), and (3) nomenclature change....................................11013 (a)(2) Introductory text amended...............................11014 660.52 Amended.....................................................11015 660.53 Nomenclature change.........................................11014 660.54 Introductory text nomenclature change.......................11014 660.55 (a)(3) nomenclature change..................................11014 660.101 Introductory text nomenclature change......................11013 660.102 (b)(1) and (c)(7) nomenclature change......................11013 660.103 (d) and (g)(2)(ii) nomenclature change.....................11013 660.105 (a) introductory and (b) nomenclature change...............11013 680 Nomenclature change............................................11014 680.1 (b)(2)(iii), (3)(iv), (c), and (d)(1) nomenclature change....11014 680.3 (e) nomenclature change......................................11013 680.11 Nomenclature change.........................................11013 Heading revised................................................11015 680.12 Nomenclature change.........................................11013 680.21 Nomenclature change.........................................11013 680.24 (e) nomenclature change.....................................11013 680.26 Introductory text and (c) nomenclature change...............11013 600.3 (d) revised..................................................11014 600.10 (a) nomenclature change.....................................11014 600.11 (f)(6) nomenclature change..................................11013 600.12 (b)(2) and (3) nomenclature change..........................11013 600.13 Nomenclature change.........................................11013 600.14 (a) amended.................................................11014 600.15 (b) nomenclature change.....................................11013 600.22 (e) nomenclature change.....................................11013 601.2 (a) nomenclature change......................................11013 (b) amended....................................................11014 601.3 (a) introductory text and (b) introductory text nomenclature change.....................................................11013 601.4 (a) nomenclature change......................................11013 601.6 (a)(2) nomenclature change...................................11013 601.9 (a) nomenclature change......................................11013 601.12 (a) and (b) nomenclature change.............................11013 601.21 Amended.....................................................11014 601.25 (b)(2) amended..............................................11014 601.31 Nomenclature change.........................................11013 601.33 Nomenclature change.........................................11013 601.51 (b) nomenclature change.....................................11013 606.20 (a) nomenclature change.....................................11014 606.100 (a) and (d)(3) nomenclature change.........................11013 606.110 (b) nomenclature change....................................11013 606.121 (c)(13), (d) introductory text, (4), and (5) nomenclature change.....................................................11014 606.170 (b) nomenclature change....................................11014 607.3 (e) nomenclature change......................................11014 [[Page 265]] 607.7 (b) and (c) nomenclature change..............................11014 607.22 (a) and (b) nomenclature change.............................11014 607.25 (b)(2) nomenclature change..................................11013 607.37 (a) introductory text and (b) amended.......................11014 607.40 (b) nomenclature change.....................................11014 610.2 (a) nomenclature change......................................11013 (b) amended....................................................11014 610.9 (b) nomenclature change......................................11014 610.11 (c)(2) and (3) nomenclature change..........................11013 610.12 (e)(2)(i) and (g)(4)(ii) nomenclature change................11013 610.13 (a) revised; OMB control number.............................28381 610.15 (a)(3) nomenclature change..................................11013 610.18 (c)(2) nomenclature change..................................11013 610.20 Introductory text nomenclature change.......................11013 610.40 (a) and (e)(2) nomenclature change..........................11013 (b)(4), (d)(1)(v) and (2)(iv) amended..........................11014 610.53 (d) nomenclature change.....................................11014 610.61 (s) removed; (t) redesignated as (s)........................10423 Technical correction...........................................14037 620.6 (h) introductory text nomenclature change....................11013 620.12 Introductory text amended...................................11015 620.13 (h) nomenclature change.....................................11013 620.14 (c)(2) and (3) nomenclature change..........................11013 (c) introductory text amended..................................11015 620.21 (b) nomenclature change.....................................11013 620.22 Nomenclature change.........................................11013 620.24 (c) introductory text, (1), and (3) nomenclature change.....11013 620.31 (a)(1) nomenclature change..................................11013 620.32 Introductory text nomenclature change.......................11013 620.35 (e) introductory text, (2), and (3) nomenclature change.....11013 620.43 Nomenclature change.........................................11013 620.44 (c) nomenclature change.....................................11013 620.45 (b) introductory text, (1), (4), and (5) nomenclature change.....................................................11013 620.48 (a) introductory text, (a)(2) and (b) nomenclature change 11013 630 Authority citation revised.....................................47875 Technical correction...........................................50279 630.1 (b) and (c) nomenclature change..............................11013 630.2 (c) nomenclature change......................................11013 630.3 Introductory text and (a) nomenclature change................11013 630.4 (e)(1) and (3) nomenclature change...........................11013 630.5 (c) introductory text and (4) nomenclature change............11013 630.10 (a), (b)(2), (4), (5), and (6) nomenclature change..........11013 630.12 (a)(1) and (b) nomenclature change..........................11013 630.14 Nomenclature change.........................................11013 630.17 (e) introductory text and (1) nomenclature change...........11013 630.30 (c)(1)(iii) nomenclature change.............................11013 (c)(1) introductory text revised...............................47875 630.31 Revised.....................................................47875 630.33 Nomenclature change.........................................11013 630.36 (h) introductory text and (1)(i) nomenclature change........11013 630.50 (c)(1)(ii) nomenclature change..............................11013 (c)(1) introductory text revised...............................47875 630.53 Nomenclature change.........................................11013 630.55 (a)(4) revised..............................................47876 630.56 (f) introductory text and (1) nomenclature change...........11013 630.60 (d)(3) and (e)(1)(ii) nomenclature change...................11013 (e)(1) introductory text revised...............................47876 630.62 (a) revised.................................................47876 630.63 Nomenclature change.........................................11013 630.66 (e) introductory text, (1)(i), and (3) nomenclature change 11013 630.70 (b) nomenclature change.....................................11013 630.72 Nomenclature change.........................................11013 630.74 (c) nomenclature change.....................................11013 [[Page 266]] 630.75 (d)(1), (i) and (2) nomenclature change.....................11013 630.80--630.86 (Subpart I) Removed.................................47876 630.81 Nomenclature change.........................................11013 630.83 Nomenclature change.........................................11013 630.86 (e) introductory text, (1)(i), and (3) nomenclature change 11013 640.2 (a) nomenclature change......................................11013 640.3 (a)(1) nomenclature change...................................11013 640.4 (a)(1) nomenclature change...................................11013 640.6 Introductory text nomenclature change........................11013 640.17 Nomenclature change.........................................11013 640.21 (c) nomenclature change.....................................11013 640.22 (c) nomenclature change.....................................11013 640.25 (c) introductory text and (3) nomenclature change...........11013 640.55 Nomenclature change.........................................11013 640.56 (c) introductory text and (2) nomenclature change...........11013 640.64 (c) introductory text nomenclature change...................11013 640.66 Nomenclature change.........................................11013 640.71 (b)(3) nomenclature change..................................11013 640.73 Nomenclature change.........................................11013 640.74 (a) and (b)(2) nomenclature change..........................11013 640.75 Removed.....................................................10423 Technical correction...........................................14037 640.82 (b) nomenclature change.....................................11013 640.92 (b) nomenclature change.....................................11013 640.101 (f) introductory text nomenclature change..................11013 640.104 (c) introductory text nomenclature change..................11013 640.111 (g) introductory text nomenclature change..................11013 640.112 (b) nomenclature change....................................11013 640.120 (Subpart L) Added..........................................10423 Technical correction...........................................14037 650.6 Introductory text, (a), and (c) nomenclature change..........11013 650.11 (c) introductory text, (1), and (5) nomenclature change.....11013 660.3 Nomenclature change..........................................11013 660.5 Nomenclature change..........................................11013 660.6 (a)(2) introductory text and (iii), (b), (c)(1), (2), and (3) nomenclature change....................................11013 660.33 Nomenclature change.........................................11013 660.34 (d) nomenclature change.....................................11013 660.36 (a)(1), (b), and (c) nomenclature change....................11013 (a) introductory text amended..................................11015 660.42 Nomenclature change.........................................11013 660.44 Nomenclature change.........................................11013 660.46 (a)(2) introductory text and (iii), (b), (c)(1), (2), and (3) nomenclature change....................................11013 (a)(2) Introductory text amended...............................11014 660.52 Amended.....................................................11015 660.53 Nomenclature change.........................................11014 660.54 Introductory text nomenclature change.......................11014 660.55 (a)(3) nomenclature change..................................11014 660.101 Introductory text nomenclature change......................11013 660.102 (b)(1) and (c)(7) nomenclature change......................11013 660.103 (d) and (g)(2)(ii) nomenclature change.....................11013 660.105 (a) introductory and (b) nomenclature change...............11013 680 Nomenclature change............................................11014 680.1 (b)(2)(iii), (3)(iv), (c), and (d)(1) nomenclature change....11014 680.3 (e) nomenclature change......................................11013 680.11 Nomenclature change.........................................11013 Heading revised................................................11015 680.12 Nomenclature change.........................................11013 680.21 Nomenclature change.........................................11013 680.24 (e) nomenclature change.....................................11013 680.26 Introductory text and (c) nomenclature change...............11013 800.20 Added.......................................................51256 801 Policy statement................................................7491 Technical correction...........................................10347 801.420 Technical correction.........................................548 801.430 (f)(2) amended; (f)(2) figure 1 revised....................17600 803.33 (b) amended.................................................11168 807.22 (a) amended.................................................11169 807.37 (a) and (b)(2) amended......................................11169 807.90 (a) revised.................................................11169 812.19 Amended.....................................................11169 813.20 (a) amended.................................................11169 814.20 (h) amended.................................................11169 820.1 (d) amended..................................................11169 [[Page 267]] 860.123 (b)(1) amended.............................................11169 864.5220 (b) and (c) revised.......................................23511 872.3100 Added.....................................................48439 872.3530 Added.....................................................48439 872.4200 Added.....................................................48439 872.4620 Added.....................................................48439 872.6250 Added.....................................................48439 872.6475 Added.....................................................48439 872.6510 Added.....................................................48439 872.6640 Added.....................................................48439 872.6710 Added.....................................................48439 872.6865 Added.....................................................48440 874.1070 Added.....................................................48440 874.1800 Added.....................................................48440 874.4750 Added.....................................................48440 874.4770 Added.....................................................48440 874.5300 Added.....................................................48440 874.5550 Added.....................................................48440 878.4635 Added.....................................................48440 878.4700 Added.....................................................48440 878.4820 Added.....................................................48440 878.4960 Added.....................................................48440 884.2980 (a) added.................................................48440 884.2982 (a) revised...............................................48441 886.1050 Added.....................................................48441 886.1070 Added.....................................................48441 886.1090 Added.....................................................48441 886.1120 Added.....................................................48441 886.1140 Revised...................................................48441 886.1160 Added.....................................................48441 886.1250 Revised...................................................48441 886.1290 Added.....................................................48441 886.1300 Added.....................................................48441 886.1340 Added.....................................................48441 886.1350 Revised...................................................48441 886.1425 Added.....................................................48442 886.1430 Added.....................................................48442 886.1435 Added.....................................................48442 886.1450 Added.....................................................48442 886.1605 Revised...................................................48442 886.1680 Added.....................................................48442 886.1690 Added.....................................................48442 886.1700 Revised...................................................48442 886.1780 Revised...................................................48442 (a) corrected..................................................51799 886.1810 Revised...................................................48442 886.1860 Revised...................................................48442 886.1870 Revised...................................................48442 886.1910 Revised...................................................48442 (a) corrected..................................................51799 886.1940 Added.....................................................48443 886.1945 Revised...................................................48443 886.4070 Revised...................................................48443 (a) corrected..................................................51799 886.4250 Revised...................................................48443 886.4335 Revised...................................................48443 886.4370 Revised...................................................48443 886.4855 Revised...................................................48443 886.5820 Added.....................................................48443 886.5900 Revised...................................................48443 886.5915 Revised...................................................48443 888.1500 Added.....................................................48443 888.5960 Added.....................................................48443 892.1100 Added.....................................................48443 892.1110 Added.....................................................48444 892.1130 Added.....................................................48444 892.1300 Added.....................................................48444 892.1320 Added.....................................................48444 892.1330 Added.....................................................48444 892.1350 Added.....................................................48444 892.1410 Added.....................................................48444 892.1640 Added.....................................................48444 892.1890 Added.....................................................48444 892.1900 Added.....................................................48444 892.1970 Added.....................................................48444 1220.40 (a) revised................................................33671 Correctly designated...........................................34797 Chapter II 1308.11 (f)(3) added; (g)(3) removed................................3588 (f)(4) correctly added..........................................9117 1308.22 table revised..............................................12162 1308.24 (i) table revised; interim; eff. 4-9-90.....................8915 1308.32 Table revised; interim......................................9114 1316.03 (a) revised................................................50827 1316.45 Amended....................................................27464 1991 21 CFR 56 FR Page Chapter I 3 Added............................................................58756 Regulation at 56 FR 58756 comment period extended to 2 21 92 66347 5 Authority citation revised................................42527, 51170 Technical correction...........................................64687 Authority citation corrected...................................65930 5.10 (a)(32) added..................................................3034 (a)(33) added..................................................42527 (b) amended.....................................................8709 5.20 (e) redesignated as (f); new (e) added........................36001 5.32 Added.........................................................58758 5.33 Added.........................................................58759 5.35 (a)(1) amended; (b) redesignated as (c); new (b) and (c)(3) added; new (c) introductory text revised...................23788 [[Page 268]] 5.56 Added.........................................................51170 5.57 Added.........................................................51170 5.67 (d) added.....................................................25025 5.80 (a)(1)(iv) added..............................................55454 5.95 Added..........................................................6263 5.100 Revised.......................................................8276 5.105 Amended.......................................................8709 5.115 Amended.......................................................8277 10.40 (b) introductory text and (d) revised........................13758 14 Authority citation revised......................................48103 14.100 Technical correction..........................................559 (d)(1)(i) and (ii) revised.....................................26613 (c)(17) added..................................................48103 50.3 (l) revised...................................................28028 56.102 (i) revised; (m) added......................................28028 56.104 (d) added...................................................28028 56.107 (a), (b) and (c) revised....................................28028 (a) corrected..................................................29756 56.108 (a) revised; (c) removed; (d) redesignated as (c); new (b) added; OMB number..........................................28028 Corrected......................................................29756 56.110 (b) revised.................................................28029 56.111 (a)(3) and (b) revised......................................28029 56.115 (a)(6) revised; OMB number..................................28029 58.90 (d) amended..................................................32088 101.42--101.45 (Subpart C) Added...................................60890 106.100 Revised; eff. 4-22-92......................................66571 161.190 (a)(2) corrected............................................6263 172.540 Added.......................................................6968 172.712 Removed....................................................42686 Technical correction...........................................46667 172.861 Added......................................................66970 173.25 (a)(20) and (b)(5) added; (b) introductory text and (d) revised....................................................16268 173.400 Added......................................................42686 Technical correction...........................................46667 175.105 (c)(5) table amended.......................................14316 175.300 (b)(3)(xxvi) revised.......................................42932 175.320 (b)(3) table amended.......................................49674 176 Technical correction............................................2585 176.170 (a)(5) table amended.....................................18, 368 (b)(2) table amended....................................19930, 49674 (b)(1) and (2) table amended...................................42932 (b)(2) table corrected.........................................65782 177.1350 (a)(3) revised............................................42932 177.1460 (b) table amended.........................................42933 177.1520 (b) table amended..................................21447, 42933 (b) table corrected............................................25446 177.1680 (a)(2) and (b) table amended..............................15278 Technical correction...........................................22910 (b) table amended..............................................42933 177.2250 (d) revised...............................................42933 177.2260 (d)(5) revised............................................42933 177.2600 (c)(4)(vi) revised........................................42933 177.2800 (d)(5) table amended......................................42933 178.2010 (b) table amended...................................1084, 43698 178.3130 (b) table amended.........................................41457 178.3295 Table amended..............................................1085 178.3297 (c) revised; (d) added; (e) table amended.................42933 (e) table corrected............................................65782 178.3400 (c) table amended.........................................41457 178.3550 Removed...................................................42935 178.3570 (a)(3) table amended......................................41456 178.3910 (a)(2) table amended......................................55456 178.3970 Removed...................................................42935 310.545 (a)(20) added; (d) revised.................................37798 Regulation at 56 FR 37792 effective date corrected; (d)(2) corrected..........................................................46823 (a)(7) amended; (d) introductory text revised; (d)(3) added; eff. 12-4-92.......................................................63568 312.120 (c)(4) revised.............................................22113 312.145 (b) amended.................................................3776 314.445 (b) amended.................................................3776 333.301--333.350 (Subpart D) Added; eff. 8-16-92...................41019 358.701--358.750 (Subpart H) Added.................................64568 361.1 (c)(3), (4) and (d)(8) amended...............................10806 429.55 (b) revised; interim........................................50249 442.216a (a)(1), (2), (b)(1)(i)(a) and (ii)(a) revised...............484 (b)(1)(ii)(a) corrected.........................................2585 500.29 Added.......................................................40506 500.30 Added.......................................................40507 510.515 (a)(4), (5), (b)(11), (15) and (17)(ii) removed; (c) table amended....................................................41912 510.600 (c)(1) table and (2) table amended.........................7805, 9623, 9840, 14019, 14641, 16269, 19022, 19023, 19263, 20126, 27196, 37472--37474, 43698, 49410, 49845, 50652, 63875, 64553, 65834 (c)(1) table amended............................................9841 514.106 (a), (b)(1)(ii), (iii), (v), (vii), (xiii), (xiv), (2)(iii), (iv), (ix) and (xiii) corrected..................12422 520 Authority citation corrected...................................14978 520.23 (a)(2) amended..............................................37473 520.45a (b) amended................................................50653 [[Page 269]] Corrected......................................................59331 520.45b (b) amended................................................50653 520.182 (b) amended................................................43699 520.540c (b) amended...............................................50653 520.550 (b) amended................................................50653 520.622c (b)(2) amended; (b)(7) removed............................50653 520.623 (b) amended................................................50653 520.816 (b) amended................................................50653 520.903d (c)(4) added..............................................50813 520.903e Added.....................................................50655 520.1010a (b) amended..............................................37473 520.1065 Removed...................................................31075 520.1204 Heading revised; (a) and (c)(2) amended....................8710 520.1205 Added......................................................8710 520.1284 (b) amended...............................................50653 520.1450c Added....................................................13396 520.1630 (d)(2) introductory text and (iii) corrected...............8710 520.1638 (b) amended...............................................50653 520.1640 (b) amended...............................................50653 520.1840 (c)(1) and (2) amended....................................50653 520.1846 (b) amended................................................9841 520.1900 (b) amended...............................................37473 520.1920 (b) amended...............................................50653 520.1921 (b) amended...............................................50653 520.2260a (b)((1) amended..........................................50653 520.2260b (a) amended..............................................50653 Corrected...............................................59331, 64288 520.2260c (b)(1) amended...........................................50653 Corrected...............................................59331, 64288 520.2604 (b) amended...............................................50653 520.2605 (b) amended...............................................50653 522.313 (d)(1)(ii) and (iii) amended...............................12119 522.540 (d)(2)(ii) amended.........................................19022 (d)(2)(i) amended..............................................50653 522.562 Removed....................................................31075 522.900 (a) removed.................................................9623 522.1081 (a)(2)(ii) amended........................................14642 (a)(2)(iii) added..............................................67175 522.1145 (e) added.................................................50814 522.1192 (d)(4)(i) revised.........................................14020 522.1290 (b) amended...............................................50653 522.1301 Removed...................................................31075 522.1680 (b) amended........................................14642, 16002 522.1720 (b)(2) amended............................................16002 (b)(1) amended.................................................19022 522.1880 (b) amended...............................................19022 522.1920 (b) amended...............................................50653 522.2477 Added.....................................................67175 524.1005 (b)(1) amended............................................50653 524.1465 (b) amended...............................................50653 524.1580b (b) amended..............................................37473 (b) amended....................................................50653 524.1580c (b) amended..............................................50653 524.1580d (b) amended..............................................37473 524.1600a (b) amended..............................................50653 524.2101 (c) introductory text amended..............................9623 524.2620 (b)(2) amended............................................37474 529.1526 (b) amended...............................................43699 540.103a (c)(2) amended............................................50653 540.103b (c)(2) amended............................................50653 540.103c (c)(2) amended............................................50654 540.103d (c)(2) amended............................................50654 540.103e (c)(2) amended............................................50654 540.103g (c)(2) amended............................................50654 540.103h (c)(2) amended............................................50654 540.107a (c)(2) amended............................................50654 540.107e (c)(4)(ii) introductory text amended......................50654 540.203 (c)(1)(ii) and (2)(ii) amended.............................50654 540.207a (c)(2)(i) amended.........................................50654 540.209 (c)(2) amended.............................................50654 540.255c (c)(2)(i) and (ii) amended................................50654 540.680 (c)(2) amended.............................................50654 540.803 (c)(2) amended.............................................50654 540.814 (c)(2)(ii) amended.........................................50654 540.814a (c)(2)(ii) amended........................................50654 540.815 (c)(2) amended.............................................50654 540.815a (c)(2) amended............................................50654 546.110c (c)(2) amended............................................20126 546.180d (c)(6)(iv)(d) added........................................7806 555.110b (c)(2)(ii) amended........................................19263 556.240 Heading and introductory text revised......................67175 556.250 Removed....................................................67175 556.308 Amended.....................................................8711 558.3 (b)(1) introductory text revised.............................19268 558.4 (d) table amended..............................19268, 29897, 41912 558.15 (g)(1) table and (2) table amended...................41912, 64702 558.20 Table amended...............................................19269 558.62 (a) and (c)(1) revised......................................19268 Corrected......................................................37839 558.76 (d)(3)(xiv) removed..........................................9623 (d)(1) table amended...........................................21076 558.95 (a)(5) removed...............................................9623 (a)(1) revised; (b)(1) heading and (2) heading amended.........49410 558.108 Added......................................................19269 558.145 (a)(1) amended.............................................14019 558.195 (d) table amended..........................................15498 Technical correction...........................................23105 558.258 (a) revised.................................................9841 558.262 Removed....................................................41912 [[Page 270]] 558.274 (a)(2), (4) and (c)(1) table amended........................9623 (a)(4) and (c)(1) table amended................................16269 558.325 (a)(2) and (6) removed......................................9623 (a)(5) amended.................................................48732 (a)(4) removed.................................................49846 (a)(11) removed................................................50049 (a)(9), (10), (12) and (15) removed............................50655 (a)(8) and (14) removed........................................66573 558.342 (c)(4)(ii), (5)(ii) and (6)(ii) amended....................14021 558.370 Removed....................................................41912 558.464 (a)(1) amended.............................................50654 558.465 (a) amended................................................50654 558.485 (a)(6) removed..............................................9623 558.530 (d)(3)(xxiv) removed.......................................12349 558.625 (b)(3), (32), (50), (60), (65), (87), and (88) removed......9623 (b)(23) removed................................................16269 (b)(27) removed................................................50655 558.630 (b)(9) removed; (b)(10) amended.............................9623 (b)(10) amended..................................16269, 19023, 50655 558.635 (b)(1) amended.............................................50654 589.1000 (Subpart B) Added.........................................40507 620.1 Revised......................................................63410 630.10--630.19 (Subpart B) Revised.................................21432 Regulation at 56 FR 21432 effective date delayed in part.......23505 630.12 (a)(3) corrected............................................27787 630.18 (a)(3) and (5) corrected....................................27787 801 Policy statement corrected......................................2677 812 Clarification..................................................29177 Regulation at 29177 corrected..................................32241 Extension of applicability.....................................35815 878 Technical corrections..........................................36871 878.3540 (c) revised...............................................14627 878.4493 Added.....................................................47151 878.5000 Added.....................................................24685 878.5010 Added.....................................................24685 878.5020 Added.....................................................24685 1020 Authority citation revised....................................36098 1020.33 (f)(2)(ii) removed; (f)(2)(iii) redesignated as (f)(2)(ii) 36098 1220.40 (a) revised................................................50250 Chapter II 1301.02 (e) revised................................................36726 1301.76 (a) revised................................................36728 1302 Labeling deadlines extension..................................42231 1306.05 (a) revised................................................25026 1306.13 (b), (c) introductory text and (1) revised.................25027 1308 Technical correction..........................................13854 1308.02 (b) through (g) redesignated as (c) through (h); new (b) added.......................................................5754 1308.12 (e)(2) through (4) redesignated as (e)(3) through (5); new (e)(2) added...............................................11932 1308.13 (f) added...................................................5754 (c)(5) removed; (c)(6) through (12) redesignated as (c)(5) through (11).......................................................11932 1308.15 (d)(1) removed; (d)(2) redesignated as (d)(1)..............61372 1308.24 (i) table revised; interim..................................9133 1308.25--1308.26 Undesignated center heading added.................42936 1308.25 Added......................................................42936 1308.26 Added......................................................42936 1308.33--1308.34 Undesignated center heading added.................42936 1308.33 Added......................................................42936 1308.34 Added......................................................42937 1310.02 (a)(13) through (24) added; (b)(5) removed; (b)(6), (7) and (8) redesignated as (b)(5), (6) and (7)................48733 1310.03 Amended.....................................................8277 1310.04 (f)(1)(xii) revised; (f)(1)(xiii) through (xxiv) added; (f)(2)(i)(E), and (ii)(E) removed; (f)(2)(i)(F), (G), (H), (ii)(F), (G) and (H) redesignated as (f)(2)(i)(E), (F), (G), (ii)(E), (F) and (G)..................................48733 1313 Policy statement..............................................19269 1313.15 (d) redesignated as (e); new (d) added.....................55076 1313.24 (d) redesignated as (e); new (d) added.....................55077 1316.75 (a) and (b) amended.........................................8686 1316.76 (a) amended.................................................8686 1316.77 (a) amended.................................................8686 1316.78 Amended.....................................................8686 1316.79 (a) amended.................................................8686 1316.81 Amended.....................................................8686 1992 21 CFR 57 FR Page Chapter I 2 Technical correction.............................................29353 2.125 (h)(2) introductory text revised.............................17980 [[Page 271]] 3 Meeting..........................................................24544 5 Authority citation revised................................10288, 18823 Technical correction...........................................29353 5.10 (a)(34) added.................................................28462 5.20 (f) redesignated as (g); new (f) added........................12875 5.22 (a)(9)(iv) revised............................................40318 5.23 (c)(4) added..................................................40318 5.25 (a)(7) added..................................................45295 5.37 (a)(2)(iii) revised; (a)(2)(iv) added.........................40318 5.38 Added.........................................................18823 5.45 (e)(1)(iii) revised...........................................40318 5.54 (a) and (b) revised; (c) added................................40316 5.55 (a) and (b) revised; (c) added................................40317 5.56 Introductory text revised; (c) and (d) added..................40317 5.57 (d) and (e) added.............................................40317 5.60 Added.........................................................40315 5.64 Added.........................................................43398 5.80 (c)(1) and (2)(i) amended.....................................17980 5.100 Amended.......................................................6475 Footnote 1 redesignated as footnote 5; footnote 5 and footnote 6 revised..........................................................10287 Revised........................................................10288 10 Technical correction............................................29353 10.30 (e)(2) introductory text amended; (e)(4) added...............17980 10.45 (d) introductory text revised................................17980 14 Authority citation revised.......................................8064 14.100 (g) added....................................................8064 (c)(15) heading and (ii) revised...............................14350 (a) revised....................................................35461 16 Authority citation revised......................................58403 16.1 (b)(1) revised................................................58403 16.5 (a)(3) revised................................................58403 60 Authority citation revised......................................56261 60.1 (a) introductory text amended.................................56261 60.3 (b)(2) and (5) amended; (b)(11)(ii), (iii), (12)(ii), (iii) and (14) revised; (b)(11)(iv), (12)(iv) and (16) added.....56261 60.10 Revised......................................................56261 60.22 (b)(1) revised; (d) redesignated as (f); new (d) and (e) added; new (f) amended.....................................56262 73.1 (a)(3) table amended..........................................32175 Regulation at 57 FR 32175 effective date confirmed.............61292 81.1 Introductory text amended.....................................10616 Regulation at 57 FR 10616 effective date corrected.............11797 101 Technical correction...........................................10522 101.42--101.45 (Subpart C) Technical correction.....................8174 106.100 Technical correction........................................6352 (k)(6) corrected................................................7435 146.135 (a) revised................................................57667 146.140 (a) amended................................................57667 146.141 (a) amended................................................57667 146.146 (a) amended................................................57667 146.151 (a) amended................................................57667 155 Technical correction...........................................37591 155.120 (a)(3)(xiii) and (a)(3)(xiv) redesignated as (a)(3)(xiv) and (a)(3)(xv); new (a)(3)(xiii) added; (b)(2)(i) revised 34245 169 Technical correction...........................................37591 169.140 (a) and (e) revised........................................34246 172 Hearing denied..................................................3698 Technical correction............................................9472 172.225 Revised....................................................12711 172.270 Added......................................................12711 172.665 (a) amended; (e) revised...................................55445 172.800 (c)(7) added...............................................57961 172.804 (c)(22) added...............................................3702 (c)(1) and (3) revised; (e)(4) added............................3703 (c)(13) revised.................................................3704 172.861 Heading corrected...........................................2814 172.880 Request for stay and hearing denied.........................6667 172.892 (h) amended; (i) added.....................................54700 173.320 (b) introductory text amended; (b)(6) added.................8065 175.105 (c)(5) table amended.......................................10810 176.170 (a)(5) table amended........................................3123 (a)(5) table amended...........................................10616 Regulation at 57 FR 10616 effective date corrected.............11797 (b)(2) table amended...........................................20200 (a)(5) table amended....................................23949, 34867 176.210 (d)(3) amended.............................................31313 177.1312 Added.....................................................32422 177.1345 Added.....................................................43399 177.1380 (a)(4) added; (b) revised...................................185 177.1395 (b)(4) table amended......................................43399 177.1520 (c) table amended.........................................10616 Regulation at 57 FR 10616 effective date corrected.............11797 177.1585 Added......................................................3940 Technical correction............................................5294 177.1632 Added......................................................3125 [[Page 272]] 177.2600 (c)(4)(i) amended..........................................3128 178 Technical correction...........................................37867 178.1005 (e)(1) table amended......................................32423 178.1010 (b)(39) and (c)(34) added.................................11682 (b)(40) and (c)(35) added......................................35463 (b)(41) and (c)(36) added......................................43614 (b)(42) and (c)(37) added......................................54701 178.2010 (b) table amended............................2019, 10811, 10992 table amended.............................10992, 18081, 48724, 48980 178.3690 (a) revised; (b)(1) amended...............................18082 178.3910 (a)(2) table amended......................................23952 182.8201 Removed; eff. 4-30-92.....................................10813 182.8455 Removed; eff. 4-30-92.....................................10813 182.8628 Removed; eff. 4-30-92.....................................10813 184.1201 Added; eff. 4-30-92.......................................10813 184.1505 (c) introductory text and (1) amended.....................10616 Regulation at 57 FR 10616 effective date corrected.............11797 184.1685 (a)(3) added...............................................6479 184.1924 Added.....................................................60473 201 Authority citation revised.....................................54300 201.105 Introductory text and (a) revised..........................54300 201.110 Removed....................................................54301 201.122 Introductory text revised..................................54301 201.307 Removed; eff. 12-9-93......................................58374 225.115 (b)(2) amended..............................................6475 310 Technical correction.....................................2136, 46067 310.201 (a)(25) removed; (b) added; eff. 12-9-93...................58374 310.305 (a) revised; (b)(2), (c)(4) and (d)(1) amended.............17980 310.537 Added......................................................29173 310.545 (a)(1), (2), (6)(i), (ii), (7), (8) and (12)(iv) amended 3526 (a)(6)(iii), (d)(4) and (5) added; (d) introductory text and (1) revised; eff. 9-14-93..........................................41860 (a)(3) amended.................................................45295 (a)(6)(i), (d) introductory text and (1) revised; (d)(6) added; eff. 12-9-93................................................58374 (a)(21), (d)(7) and (8) added; (d) introductory text revised; eff. 6-18-93.......................................................60423 (a)(10)(iv) and (d)(9) added; (d) introductory text revised; eff. 6-18-93.......................................................60427 (a)(22) and (d)(10) added; (d) introductory text revised; eff. 6-18-93............................................................60431 312 Technical correction...........................................19458 312.34 (a) amended.................................................13248 312.35 (a) amended.................................................13249 312.42 (b)(3)(iii) and (4) added...................................13249 312.44 (b)(1)(xi) added; (b)(2)(i) revised.........................13249 312.145 (b) amended................................................10814 314 Technical correction...........................................61489 314.1 (a)(1) and (2) amended.......................................17981 314.3 (b) revised..................................................17981 314.50 Introductory text amended, (a)(2) and (c)(1) amended; (g)(3) added...............................................17982 314.54 Added.......................................................17982 (a)(2) corrected...............................................61612 314.55 Removed.....................................................17983 314.56 Removed.....................................................17983 314.60 Existing text designated as (a) and amended; (b) added......17983 314.70 (e) added...................................................17983 314.71 (b) amended.................................................17983 314.80 (a), (c)(1)(ii) and (d)(1) amended; (b) revised.............17983 314.81 (b)(3)(iii) added...........................................17983 314.92--314.99 (Subpart C) Added...................................17983 314.94 (a)(9)(iii) corrected.......................................29353 314.100--314.170 (Subpart C) Redesignated as subpart D.............17983 Heading revised................................................17987 314.100 Revised....................................................17987 314.101 Revised....................................................17987 (d)(3) and (4) corrected.......................................29353 314.102 Revised....................................................17988 (b) corrected..................................................29353 314.103 (a) revised; (b) and (c)(2) amended........................17989 314.104 Revised....................................................17989 314.105 Revised....................................................17989 314.110 Revised....................................................17989 314.120 Revised....................................................17990 314.122 Added......................................................17990 (b) corrected..................................................29353 314.125 Heading, (a) introductory text, (b) introductory text, (7), (9), (10), (12), (14), (15), (16) and (17) revised; (b)(18) added..............................................17991 314.127 Added......................................................17991 (a)(3)(iii)(A)(1) corrected....................................29353 314.150 Revised....................................................17993 314.151 Added......................................................17994 314.152 Revised....................................................17994 314.153 Added......................................................17995 [[Page 273]] 314.160 Revised....................................................17995 314.161 Added......................................................17995 314.162 Added......................................................17996 314.200--314.235 (Subpart D) Redesignated as subpart E.............17983 314.200 (a) introductory text, (b)(1) and (c)(3) revised; (c)(1) and (g)(1) amended.........................................17996 314.300 (Subpart E) Redesignated as subpart F......................17983 314.410--314.445 (Subpart F) Redesignated as subpart G.............17983 314.430 Heading, (a) through (d), (e) introductory text, (f)(5), (6) and (g) introductory text revised......................17996 314.440 Heading, (a) introductory text, (1) and (2) revised........17997 314.500--314.560 (Subpart H) Added.................................58958 316 Added..........................................................62085 320.1 (a) and (e) revised..........................................17997 320.21--320.32 (Subpart B) Heading revised.........................17998 320.21 Revised.....................................................17998 320.22 Revised.....................................................17998 320.23 Revised.....................................................17999 320.24 Revised.....................................................17999 (b)(4) corrected...............................................29354 320.30 Revised.....................................................18000 320.31 Revised.....................................................18000 320.32 Redesignated as 320.38; new 320.32 redesignated from 320.51 and revised................................................18000 320.33 Redesignated from 320.52; heading and introductory text revised....................................................18001 320.34 Redesignated from 320.55....................................18001 320.35 Redesignated from 320.56....................................18001 320.36 Redesignated from 320.62....................................18001 320.38 Redesignated from 320.32....................................18000 320.50 Removed.....................................................18000 320.51 Redesignated as 320.32......................................18000 320.52 Redesignated as 320.33......................................18001 320.53 Removed.....................................................18001 320.54 Removed.....................................................18001 320.55 Redesignated as 320.34......................................18001 320.56 Redesignated as 320.35......................................18001 320.57 Removed.....................................................18001 320.58 Removed.....................................................18001 320.59 Removed.....................................................18001 320.60 Removed.....................................................18001 320.61 Removed.....................................................18001 320.62 Redesignated as 320.36......................................18001 341.3 (e) added; eff. 12-9-93......................................58374 341.12 Added; eff. 12-9-93.........................................58374 341.72 Added; eff. 12-9-93.........................................58374 341.78 (b) amended; (c)(1) and (2) redesignated as (c)(2) and (1); new (c)(2) revised; (c)(3) added...........................29177 341.90 (e) through (q) added; eff. 12-9-93.........................58376 348 Added; eff. 6-19-93............................................27656 358 Technical correction............................................2136 Authority citation revised.....................................44494 358.550 (d)(2) revised.............................................44494 369.20 Amended; eff. 12-9-93.......................................58376 369.21 Amended; eff. 12-9-93.......................................58376 433.1 (d)(2) amended...............................................18001 500.27 (d) amended..................................................6475 500.51 (c) amended..................................................6475 510 Technical correction...........................................21854 510.112 (e) amended.................................................6475 510.302 (d) amended.................................................6475 510.310 (f) amended.................................................6475 510.600 (c)(1) table and (2) table amended.........................2836, 5052, 7651, 8577, 11683, 12711, 26995, 30641, 31313, 32175, 35988, 38442, 45984, 48163, 54176, 61796 511.1 (e) amended...................................................6475 514.1 (d)(2) amended................................................6475 520 Authority citation corrected....................................6352 520 Heading revised................................................37319 520.88 Added.......................................................37319 520.88a Added......................................................37319 520.88b Added......................................................37319 (b)(1)(ii)(B) corrected........................................42623 520.88c Added......................................................37319 520.88d Added......................................................37319 (c) corrected..................................................42623 520.88e Added......................................................37320 520.88f Added......................................................37320 520.88g Added......................................................37320 520.88h Added......................................................37320 520.90 Added.......................................................37321 520.90a Added......................................................37321 520.90b Added......................................................37321 520.90c Added......................................................37321 520.90d Added......................................................37321 520.90e Added......................................................37322 520.90f Added......................................................37322 520.154 Added......................................................37322 520.154a Added.....................................................37322 (d)(3)(iii) corrected..........................................42623 520.154b Added.....................................................37322 [[Page 274]] 520.154c Added.....................................................37322 520.390 Added......................................................37323 520.390a Added.....................................................37323 520.390b Added.....................................................37323 520.390c Added.....................................................37323 (c)(1) corrected...............................................42623 520.445 Added......................................................37323 520.445a Added.....................................................37323 520.445b Added.....................................................37324 (b), (d)(1)(iv)(A) introductory text and (2)(i)(D)(1) corrected; (d)(2)(i)(C) correctly designated.......................42623 520.445c Added.....................................................37325 520.580 (b)(1) amended......................................35989, 45984 520.608 Added......................................................37325 520.1130 Added.....................................................37325 520.1130a Added....................................................37325 520.1130b Added....................................................37326 520.1130c Added....................................................37326 520.1242g (c) amended...............................................7652 520.1448b (b) amended...............................................5052 520.1484 Added.....................................................19085 (b) revised....................................................26604 520.1660d (b) revised..............................................42490 520.1696 Added.....................................................37326 520.1696a Added....................................................37326 520.1696b Added....................................................37326 520.1696c Added....................................................37326 (c) corrected..................................................42623 520.1696d Added....................................................37327 520.1720b (b) amended...............................................2836 520.1806 (b) amended...............................................48163 520.1880 Added......................................................4718 520.2041 (b) amended...............................................48163 520.2042 (b) amended...............................................48163 520.2087 (b) amended................................................8577 520.2088 (a)(2) and (b)(2) amended..................................8577 520.2158 Added.....................................................37327 520.2158a Added....................................................37327 520.2158b Added....................................................37327 (b) corrected..................................................42623 520.2158c Added....................................................37327 520.2220a (b) amended..............................................32176 520.2345 Added.....................................................37327 520.2345a Added....................................................37327 520.2345b Added....................................................37327 520.2345c Added....................................................37328 520.2345d Added....................................................37328 (e)(1)(i)(A), (ii)(A) and (4)(iii)(A)(1) corrected.............42623 520.2345e Added....................................................37329 520.2345f Added....................................................37329 520.2345g Added....................................................37329 520.2345h Added....................................................37329 522 Technical correction............................................5295 Heading revised................................................37330 522.88 Added.......................................................37330 522.90 Added.......................................................37330 522.90a Added......................................................37330 522.90b Added......................................................37331 (d)(3)(ii) corrected...........................................42623 522.90c Added......................................................37331 522.313 (d)(2) and (3) added.......................................41862 522.390 Added......................................................37331 522.650 Added......................................................37331 (b) corrected..................................................42623 522.840 (a), (c)(1) and (3) amended................................41861 522.1145 (d)(2) amended.............................................2837 522.1696 Added.....................................................37332 522.1696a Added....................................................37332 (d)(2) introductory text corrected.............................42623 522.1696b Added....................................................37332 Heading, (d)(3)(ii) and (e)(1)(ii) corrected...................42623 522.1696c Added....................................................37333 522.2100 (a)(1) amended............................................21209 522.2471 Added.....................................................12712 522.2477 (b) corrected..............................................5052 524 Heading revised................................................37333 524.154 Added......................................................37333 524.155 Added......................................................37333 524.390 Added......................................................37333 524.390a Added.....................................................37333 524.390b Added.....................................................37333 524.390c Added.....................................................37334 524.390d Added.....................................................37334 524.900 (c) amended.................................................7652 524.1005 (b)(1) amended............................................31314 526 Heading revised................................................37334 526.88 Added.......................................................37334 526.464 Added......................................................37334 526.464a Added.....................................................37334 (c)(2) corrected...............................................42623 526.464b Added.....................................................37334 (c)(2) and (3) corrected.......................................42623 526.464c Added.....................................................37335 526.464d Added.....................................................37335 526.1130 Added.....................................................37335 526.1696 Added.....................................................37335 526.1696a Added....................................................37335 526.1696b Added....................................................37336 526.1696c Added....................................................37336 (a) corrected..................................................42623 526.1696d Added....................................................37336 (c)(1)(iii) corrected..........................................42623 529 Heading revised................................................37336 529.1030 (b) amended...............................................42490 529.2464 Added.....................................................37336 [[Page 275]] 536 Removed........................................................37336 539 Removed........................................................37336 540 Removed........................................................37336 540.274b (c)(3)(iv)(c) amended.....................................32896 544 Removed........................................................37336 546 Removed........................................................37336 546.180d (c)(6)(i)(a)(3), (b)(3), (ii)(d), (iii)(a)(3), (b)(3), (c)(3), (iv)(a)(3) and (b)(3)...............................7651 Corrected.......................................................8961 (c)(6)(iv)(d)(3) amended.......................................12711 (c)(6)(i)(a)(3), (b)(3), (ii)(d), (iii)(a)(3), (b)(3), (c)(3), (iv)(a)(3) and (b)(3) amended......................................26996 548 Removed........................................................37336 548.114 (c)(2) amended..............................................7652 555 Removed........................................................37336 556.113 Revised....................................................41862 556.308 Amended....................................................21209 556.735 Added......................................................12712 558 Technical correction....................................21854, 44791 558.4 (d) table amended..............................................525 (c) revised.....................................................1642 Technical correction............................................5210 (d) table amended; eff. 6-30-92.................................6072 Corrected.......................................................6892 (d) amended....................................................38442 558.5 (c)(2) amended................................................6475 558.15 (d) and (e) amended..........................................6476 (g)(2) table amended............................................8577 (g)(1) table and (2) table corrected...........................14639 558.20 Removed......................................................1642 Technical correction............................................5210 558.55 (d)(2) table corrected; CFR correction......................12712 558.58 (d)(1) table amended...................................7652, 8577 558.76 (d)(3)(xiii) revised........................................32176 558.78 (a)(2), (d)(1) table and (d)(2)(ii) amended..................7652 558.95 (b)(1)(iii)(b), (iv)(b), (v)(b), (vii)(b), (ix)(b), (x)(b) and (xi)(b) amended.........................................8577 (a)(2) amended.................................................23059 558.105 (d)(1)(ix)(b) amended.......................................8577 558.108 Removed......................................................525 558.120 (c)(1)(iii)(b) amended......................................7652 558.195 (d) table amended...........................................8577 558.235 Added......................................................38442 558.254 (a) amended.................................................7652 558.258 (a) and (c)(1)(i) revised; (c)(1)(ii) and (iii) redesignated as (c)(1)(i)(A) and (B); new (c)(1)(ii) through (v) added..........................................34516 558.274 (a)(2), (4) and (c)(1) table amended.......................37410 558.311 (e)(1) table amended........................................8577 558.325 (c)(4)(ii) added...........................................34517 558.342 (c)(4)(ii), (5)(ii) and (6)(ii) revised.....................5053 Technical correction............................................6892 558.355 (f)(3)(viii) added..........................................5054 (f)(1)(xxiv) revised............................................6554 Technical correction............................................6892 (b)(9), (f)(1)(iv)(b), (v)(b), (xv)(b) and (xvi)(b) amended.....7652 (f)(1)(x)(b), (xi)(b), (xii)(b), (xv)(b), (xvi)(b), (xviii)(b), (xix)(b), (xx)(b) and (xxiii)(b) amended................8578 (f)(3)(ii)(a) revised; (f)(3)(ix) added........................11683 (b)(7) and (14) revised........................................23953 (b)(11) revised; (f)(1)(xxv) added.............................46504 558.363 (c)(1)(v)(B) amended........................................8578 (c)(1)(vi) added...............................................32176 558.369 (a) amended.................................................8578 558.430 (a) amended.................................................8578 558.515 (d)(1)(ii)(b) amended.......................................8578 558.530 (a)(2) amended..............................................8578 558.550 (b)(1)(vii)(c) and (ix)(c) amended..........................7652 558.625 (b)(51) removed............................................23059 (b)(3) added...................................................37410 (b)(28) removed................................................54176 558.630 (b)(10) amended............................................37410 558.680 (c)(1) table revised........................................8403 (a) amended.....................................................8578 570.6 (e) amended...................................................6476 571.1 (c) amended...................................................6476 573 Hearing........................................................28606 Hearing denied.................................................33244 Technical correction...........................................40318 573.870 Added.......................................................7875 (a) table amended..............................................24187 601.40--601.46 (Subpart E) Added...................................58959 Technical correction...........................................61489 606.60 (c) amended.................................................11263 (c) corrected..................................................12862 606.121 (a) amended................................................10814 610.41 Amended.....................................................10814 620.1 Technical correction..........................................2135 630.4 (e)(3) amended...............................................10814 640.67 (a) amended.................................................10814 720.1 Revised.......................................................3129 720.2 Revised.......................................................3129 720.3 Revised.......................................................3129 [[Page 276]] 720.4 (a) introductory text, (b) introductory text, (c)(13) introductory text and (e) amended; (b)(5), (c)(12)(xi) and (xii) removed; (c)(12)(iii), (iv), (v), (ix), (x) and (d) revised; OMB number.........................................3129 720.5 Removed.......................................................3130 Technical correction............................................5210 720.6 Revised; OMB number...........................................3130 720.7 Revised.......................................................3130 720.8 (a) amended...................................................3130 720.9 Revised.......................................................3130 807.3 (n) through (q) added; interim...............................18066 Regulation at 57 FR 18066 stayed...............................23059 807.87 (h) redesignated as (k); new (h), (i) and (j) added; interim....................................................18066 Regulation at 57 FR 18066 stayed...............................23059 (i)(2) corrected...............................................29354 807.92 Added; interim..............................................18066 Regulation at 57 FR 18066 stayed...............................23059 807.93 Added; interim..............................................18067 Regulation at 57 FR 18067 stayed...............................23059 807.94 Added; interim..............................................18067 Regulation at 57 FR 18067 stayed...............................23059 807.95 (c)(3) removed; (d) redesignated as (e); new (d) added; interim....................................................18067 Regulation at 57 FR 18067 stayed...............................23059 807.100 Added......................................................58403 812 Extension of applicability..............................12875, 29001 814.44 (a) revised.................................................58403 821 Added..........................................................22967 860.3 (c)(1) amended; (c)(2) and (3) revised.......................58403 860.84 (a) amended.................................................58404 860.120 (c) amended................................................58404 860.130 (e) and (f) amended; (c) through (f) redesignated as (d) through (g); new (c) added.................................58404 860.134 Heading, (a) introductory text, and (b)(3) revised.........58404 861 Authority citation revised.....................................58404 861.1 (a) and (b) revised..........................................58404 861.20 Revised.....................................................58404 861.22 Removed.....................................................58405 861.24 (a) introductory text and (b) revised.......................58405 861.26 Removed.....................................................58405 861.28 Removed.....................................................58405 861.30 Revised.....................................................58405 861.32 Removed.....................................................58405 861.36 (c) amended.................................................58405 861.38 (b)(2) revised..............................................58405 895.20 Amended.....................................................58405 895.21 (b), (d)(4) and (8) revised.................................58405 895.30 (c) and (d) amended.........................................58405 1220.40 (a) revised................................................38771 1240.3 (i) through (p) redesignated as (k) through (r); new (i) and new (j) added..........................................57344 1240.61 (a) revised................................................57344 Chapter II 1302 Labeling deadlines extension...................................5817 1308.11 (g)(3) added...............................................18825 (g)(4) added...................................................43401 1308.12 (b)(1) introductory text revised...........................31126 1308.24 (i) table revised; interim..................................5818 Regulation at 57 FR 5818 confirmed.............................36371 1308.26 (a) table revised; interim.................................19534 Regulation at 57 FR 19534 confirmed............................36372 1308.32 Introductory text revised..................................23301 1308.33 (c)(10)(a) and (b) correctly designated as (c)(10)(i) and (ii).......................................................10815 1308.34 Table revised.......................................32423, 55091 1310.02 (b)(8) and (9) added.......................................43615 1310.04 (f)(2)(iv) added...........................................43615 1310.05 (c) added...................................................2461 1310.06 (c) revised; (e), (f) and (g) added.........................2462 1310.08 Added......................................................43615 Chapter III Chapter III Chapter established....................................55089 1401 Added.........................................................59803 1402 Added.........................................................55089 1403 Added.........................................................55092 1404 Added.........................................................56263 [[Page 277]] 1993 21 CFR 58 FR Page Chapter I Chapter I Technical correction.....................................17085 Meetings.......................................................48597 IOM Implementation report.......................................2470 1 Technical correction.............................................19876 1.1 (c) amended; eff. 5-8-94.......................................17085 1.24 (a)(14) revised; eff. 2-14-94..................................2174 Regulation at 58 FR 2174 effective date corrected to 5-8-94....17328 2.125 (e)(13) added.................................................6088 5 Implementation at 57 FR 56347 revoked.............................2066 Implementation; eff. 5-8-94.....................................2070 Regulatory impact analysis statement............................2927 Technical correction....................................17096, 60105 Authority citation revised..............................17106, 64490 Clarification..................................................44033 5.10 (a)(18) introductory text revised.............................17095 (a)(35) added..................................................17106 (a)(36) added..................................................64490 5.20 (e) through (g) redesignated as (f) through (h); new (e) added......................................................17095 5.22 (c) amended...................................................17095 5.29 Added.........................................................17106 5.31 (d) introductory text and (2) revised.........................41634 5.34 Added.........................................................39142 5.35 (b) introductory text and (c)(3) revised; (b)(1) through (5) redesignated as (b)(1)(i) through (v); new (b)(1) introductory text and (2) added..............................494 (c) redesignated as (d); new (d) introductory text revised; new (c) and (d)(4) added...........................................42496 5.39 Added.........................................................18346 5.61 Heading revised; (g) added; eff. 2-14-94.......................2410 Regulation at 58 FR 2410 effective date corrected to 5-8-94....17341 5.80 (a)(1)(i) amended; (d) redesignated as (f); (c) introductory text, (1)(i) through (iii) and new (f) introductory text revised; (c)(1)(iv), new (d) and (e) added.................17094 5.99 Added.........................................................34213 5.100 Revised......................................................17091 5.115 Amended......................................................17093 10 Authority citation revised......................................49190 10.50 (c)(1) revised; (c)(20) and (21) added.......................49190 12.50 (a) and (c) amended..........................................17096 14 Authority citation revised......................................41635 14.100 (c)(1)(ii) amended..........................................17096 (d)(4) added...................................................41635 (c)(17) heading revised........................................62521 16.1 (b)(2) amended; interim.......................................65520 20 Implementation at 57 FR 56347 revoked............................2066 Implementation; eff. 5-8-94.....................................2070 Regulatory impact analysis statement............................2927 Technical correction....................................17096, 17097 20.89 (c) added....................................................61603 20.100 Heading revised; (c)(34) added; eff. 5-8-93..................2533 20.108 (d) added...................................................48794 (c) revised....................................................48796 73 Technical correction............................................36134 73.3106 Revised....................................................17507 Regulation at 58 FR 17507 eff. date confirmed..................41182 73.3121 (a)(8) and (9) amended; (a)(10) added.......................9541 Regulation at 58 FR 9541 eff. date confirmed...................41024 73.3127 Added.......................................................3227 (a), (b)(1) and (2) revised....................................17510 Regulation at 58 FR 3227 confirmed.............................33909 Regulation at 58 FR 17510 eff. date confirmed..................41183 74.101 (b) revised.................................................17511 Regulation at 58 FR 17511 eff. date confirmed..................41183 74.1109 (b) amended................................................17098 74.2101 (a) revised................................................17511 Regulation at 58 FR 17511 eff. date confirmed..................41183 74.3206 (c)(1)(iv) and (v) amended; (c)(1)(vi) added...............21542 Regulation at 58 FR 21542 eff. date confirmed..................45841 74.3602 (b)(2)(iii) added..........................................60109 100 Implementation at 57 FR 56347 revoked...........................2066 Implementation; eff. 5-8-94.....................................2070 Authority citation revised......................................2467 Regulatory impact analysis statement............................2927 Technical correction...........................................17096 100.1 (Subpart A) Added.............................................2468 100.2 Added.........................................................2460 (d), (f), (g), and (h) introductory text corrected.............17097 [[Page 278]] 100.100 (Subpart F) Added...................................27933, 64136 101 Implementation at 57 FR 56347 revoked...........................2066 Implementation; eff. 5-8-94.....................................2070 Regulatory impact analysis statement............................2927 Technical correction.......17085, 17096, 17099, 17100, 17101, 17102, 17343, 19876, 59657 Clarification..................................................44033 101.2 (b) and (f) revised; eff. 5-8-94.........................44030 101.3 (e)(4)(ii) revised; eff. 5-8-94...............................2227 101.4 (a)(1) and (b)(2)(i) revised; eff. 5-8-93.....................2875 (b)(20) through (22), (d), (e) and (f) added, eff. 5-8-94.......2875 101.6 Removed; eff. 5-8-94..........................................2875 Removal at 58 FR 2850 effective date corrected to 5-8-93.......17103 101.8 (a) revised; eff. 5-8-94......................................2291 101.9 Revised; eff. 2-14-94.........................................2175 (b) revised; eff. 5-8-94........................................2291 (c)(7)(iii), (8)(iv) and (9) added; eff. 5-8-94.................2227 (k)(1) added; eff. 2-14-94......................................2533 (b)(5)(iv) and (b)(7) corrected; eff. 5-8-94...................17086 (k)(1) addition at 58 FR 2478 effective date corrected to 5-8- 94.................................................................17097 (c)(8)(iv) corrected...........................................17104 Regulation at 58 FR 2175 effective date corrected to 5-8-94....17328 (c)(1)(i)(A), (6)(iii), (7)(ii), (8)(i), (ii), (B), (d)(8), (9)(i), (ii) and (iii) corrected...................................17328 (d)(12) sample label correctly revised.........................17329 (e) introductory text corrected; (e)(5) sample label correctly revised............................................................17330 (f)(2)(ii), (iv), (g)(8), (9), (h)(3)(iv), (j)(4) and (13)(ii)(A) corrected; (j)(13)(ii)(A) sample label correctly revised............................................................17331 (b) revised; eff. 5-8-94.......................................44048 (a) introductory text and (d) amended; (c)(1)(i), (2), (8)(vi), (d)(1)(ii)(D), (iii), (7), (11), (e)(5) sample label, (f)(4), (5), (j)(1)(i), (2)(i), (ii), (iii), (j)(3)(v), (4), (5)(ii), (10), (13)(i), (ii)(A), (B), (C), (14) and (15)(iii) revised; (j)(2)(iv) redesignated as (j)(2)(v); (d)(13), (14) and new (j)(2)(iv) added; eff. 5-8-94..................................44076 (j)(13)(ii)(A)(1) and (B) corrected............................59363 (b)(2)(G) corrected............................................60109 101.10 Revised; eff. 2-14-95........................................2410 Regulation at 58 FR 2410 eff. date corrected in part to 5-8-94 and 5-8-95.........................................................17341 101.12 (Subpart A) Added; eff. 5-8-94...............................2293 (a)(4) and (b) table 1 corrected...............................17086 (b) table 2 correctly revised..................................17087 (h)(11)(i) corrected...........................................17091 Revised; eff. 5-8-94...........................................44051 (b) Table 2 corrected..........................................60109 101.13 Revised; eff. 2-14-94........................................2410 (q)(5) revised; eff. 2-14-95....................................2410 101.13 Regulation at 58 FR 2410 effective date corrected in part to 5-8-94 and 5-8-95.......................................17341 (i)(1), (2), (3), (j)(2)(i), (m)(1)(ii), and (p)(1) corrected; effective 5-8-94...................................................17342 (q)(5)(i) corrected; eff. 5-8-95...............................17342 (b)(4) added; (d)(2), (f), (g) introductory text, (1), (i)(2), (j)(1)(ii)(B), (l)(1)(ii) introductory text, (m)(1)(ii) introductory text and (q)(2) revised; (h)(1) amended; eff. 5-8-94 44030 101.14 Added; eff. 5-8-93...........................................2533 (d)(2)(vii)(B) and (3) added; eff. 5-8-94.......................2533 (d)(2)(vii)(A) and (B) corrected...............................17097 (e)(6) revised.................................................44038 101.22 (h)(7) added; eff. 5-8-94....................................2875 (k) added; eff. 5-8-93..........................................2875 101.25 Removed; eff. 2-14-94........................................2413 Regulation at 58 FR 2413 effective date corrected to 5-8-94....17341 101.30 Added; eff. 5-8-93...........................................2925 [[Page 279]] (e)(2) and (l) revised; (h)(1) table amended...................44063 (m) added......................................................49192 101.35 Removed; eff. 5-8-94.........................................2876 101.54--101.69 (Subpart D) Added; eff. 2-14-94......................2413 Regulation at 58 FR 2413 effective date corrected to 5-8-94....17341 101.54 (a), (b)(1), (e)(1)(i), (iii)(A) and (2)(i) corrected; eff. 5-8-94.....................................................17342 101.56 (a) introductory text, (3), (d)(2) and (g) corrected; eff. 5-8-94.....................................................17342 101.60 (b)(2)(i), (ii), and (iii) redesignated as (b)(2)(i)(A), (B) and (b)(2)(ii); (b)(2) introductory text, new (b)(2)(i)(B), (b)(4)(ii)(A), (b)(5)(ii)(A), (c)(4)(ii)(A) and (5)(ii)(A) corrected; eff. 5-8-94......................17342 (a) introductory text, (b)(1)(i) and (c)(1)(i) revised; (b)(2)(i)(B) amended; eff. 5-8-94..................................44031 101.61 (a), (b)(2), (3), (4), (5), (6)(ii)(A) and (7)(ii)(A) corrected; eff. 5-8-94.....................................17342 (a) introductory text and (b)(1)(i) revised; (b)(2)(i)(B) and (b)(4)(i)(B) amended; eff. 5-8-94..................................44032 101.62 (b)(2), (3), (4)(ii)(A), (5)(ii)(A), (6)(ii), (c) introductory text, (4) introductory text, (4)(ii)(A), (5)(ii)(A) and (d)(1)(ii) corrected; eff. 5-8-94...........17342 (d)(2)(ii)(B), (d)(4) introductory text and (4)(i) corrected; eff. 5-8-94........................................................17343 (b)(1)(i), (c)(1)(i), (d)(1)(i)(A), (d)(1)(ii)(A), (e)(1) and (2) revised; (b)(2)(i)(B), (d)(1)(i) introductory text, (d)(1)(ii) introductory text, (d)(2)(ii) introductory text, (d)(2)(ii), (A), (d)(2)(iv) introductory text, (d)(2)(iv)(A), (d)(4)(i) introductory text and (d)(4)(ii) introductory text amended; eff. 5-8-94.............................................................44032 (b)(2)(i)(B), (d)(1)(i), (ii), (d)(2)(ii), (ii)(A), (iv), (iv)(A), (d)(4)(i) and (ii) corrected; eff. 5-8-94.................60105 101.65 (b) and (c)(3) corrected; eff. 5-8-94.......................17343 101.67 Added; eff. 5-8-94...........................................2455 101.69 (m)(1), (n)(1) and (o)(1) corrected; eff. 5-8-94............17343 (m)(1), (n)(1) and (o)(1) amended; (m)(1)(E), (n)(1)(C) and (o)(1)(C) added; eff. 5-8-94.......................................44033 101.70--101.71 (Subpart E) Added; eff. 5-8-93.......................2534 101.70 (f) corrected...............................................17097 101.71 (a) added; eff. 5-8-93.......................................2548 (b) added; eff. 5-8-93..........................................2578 (c) added; eff. 5-8-93..........................................2620 (d) added; eff. 5-8-93..........................................2639 (e) added; eff. 5-8-93..........................................2664 (f) added; eff. 5-8-93..........................................2714 (b) correctly designated.......................................17100 101.72 Added; eff. 5-8-93...........................................2676 (c)(2)(ii)(C) corrected........................................17101 101.73 Added; eff. 5-8 93...........................................2801 Heading and tables 1 and 2 corrected; eff. 5-8-94..............17343 Table 2 corrected; eff. 5-8-94...................17344, 17345, 17346 101.74 Added; eff. 5-8-93...........................................2836 (b)(3) corrected; eff. 5-8-93..................................17100 101.75 Added; eff. 5-8-93...........................................2757 101.76 Added; eff. 5-8-93...........................................2548 101.77 Added; eff. 5-8-93...........................................2578 101.78 Added; eff. 5-8-93...........................................2639 101.95 (Subpart F) Added; eff. 2-14-94..............................2426 (Subpart F) Regulation at 58 FR 2426 effective date corrected to 5-8-94..........................................................17341 101.100--101.108 (Subpart F) Redesignated as subpart G; eff. 2-14- 94..........................................................2426 Regulation at 58 FR 2426 effective date corrected to 5-8-94....17341 101.100 (d) introductory text revised; eff. 2-14-94.................2188 (a)(2) revised; eff. 5-8-94.....................................2876 Regulation at 58 FR 2189 effective date corrected to 5-8-94....17328 101 Appendix B added; eff. 2-14-94..................................2189 Regulation at 58 FR 2188 effective date corrected to 5-8-94....17328 Appendix B corrected....................................17332, 17333 102 Technical correction...........................................17103 102.22 Added; eff. 5-8-94...........................................2876 102.30 Removed; eff. 5-8-94.........................................2926 102.32 Removed; eff. 5-8-94.........................................2926 102.33 Revised; eff. 5-8-94.........................................2926 [[Page 280]] (c) corrected..................................................17103 (g) redesignated as (g)(1); (g)(2) added; eff. 5-8-94..........44063 103.35 (d)(3) added; eff. 7-6-93.....................................381 104 Technical correction...........................................17104 104.20 (a) amended; (c)(1) and (d)(3) revised; eff. 5-8-94..........2228 105 Implementation at 57 FR 56347 revoked...........................2066 Implementation; eff. 5-8-94.....................................2070 Regulatory impact analysis statement............................2927 Technical correction....................................17096, 17104 Clarification..................................................44033 105.66 Revised; eff. 5-8-94.........................................2430 130 Implementation at 57 FR 56347 revoked...........................2066 Implementation; eff. 5-8-94.....................................2070 Regulatory impact analysis statement............................2927 Technical correction.............................17096, 17103, 17105 Clarification..................................................44033 130.3 (e) added; eff. 5-8-93........................................2876 130.9 Added; eff. 5-8-93............................................2876 130.10 Added; eff. 5-8-94...........................................2446 130.11 Added; eff. 5-8-93...........................................2876 131 Technical correction...........................................17105 131.110 (f) revised; eff. 5-8-93....................................2890 131.111 (h) revised; eff. 5-8-93....................................2890 131.112 (g) revised; eff. 5-8-93....................................2890 131.115 (f) revised; eff. 5-8-93....................................2890 131.120 (e) revised; eff. 5-8-93....................................2890 131.122 (e) revised; eff. 5-8-93....................................2890 131.123 (f) revised; eff. 5-8-93....................................2890 131.125 (e) revised; eff. 5-8-93....................................2890 131.127 (f) revised; eff. 5-8-93....................................2890 131.130 (f) revised; eff. 5-8-93....................................2890 131.132 (f) revised; eff. 5-8-93....................................2890 131.135 (f) revised; eff. 5-8-93....................................2890 131.136 (h) revised; eff. 5-8-93....................................2890 131.138 (g) revised; eff. 5-8-93....................................2891 131.143 (f) revised; eff. 5-8-93....................................2891 131.144 (h) revised; eff. 5-8-93....................................2891 131.146 (g) revised; eff. 5-8-93....................................2891 131.147 (f) revised; eff. 5-8-93....................................2891 131.149 (e) revised; eff. 5-8-93....................................2891 131.150 (e) revised; eff. 5-8-93....................................2891 131.155 (e) revised; eff. 5-8-93....................................2891 131.157 (e) revised; eff. 5-8-93....................................2891 131.160 (e) revised; eff. 5-8-93....................................2891 131.162 (e) revised; eff. 5-8-93....................................2891 131.170 (h) revised; eff. 5-8-93....................................2891 131.180 (e) revised; eff. 5-8-93....................................2891 131.185 (e) revised; eff. 5-8-93....................................2891 131.187 (e) revised; eff. 5-8-93....................................2891 131.200 (g) revised; eff. 5-8-93....................................2891 131.203 (g) revised; eff. 5-8-93....................................2891 131.206 (g) revised; eff. 5-8-93....................................2891 133.102 (e) revised; eff. 5-8-93....................................2891 133.103 Revised; eff. 5-8-93........................................2892 133.104 Revised; eff. 5-8-93........................................2892 133.106 (d) introductory text revised; eff. 5-8-93..................2892 133.108 (d) introductory text revised; eff. 5-8-93..................2892 (d) introductory text corrected................................17105 133.111 (f) revised; eff. 5-8-93....................................2892 133.113 (d) introductory text revised; eff. 5-8-93..................2892 133.118 (f) added; eff. 5-8-93......................................2892 133.121 Introductory text revised; eff. 5-8-93......................2892 133.123 (f) introductory text revised; eff. 5-8-93..................2892 133.124 (h) revised; eff. 5-8-93....................................2892 133.125 (a) introductory text revised; eff. 5-8-93..................2892 133.127 (d) revised; eff. 5-8-93....................................2892 133.128 (e) revised; eff. 5-8-93....................................2892 133.129 (e) revised; eff. 5-8-93....................................2892 133.131 Introductory text revised; eff. 5-8-93......................2892 133.133 (d) introductory text revised; eff. 5-8-93..................2892 133.134 (d) introductory text revised; eff. 5-8-93..................2893 133.136 (d) introductory text revised; eff. 5-8-93..................2893 133.138 (d) introductory text revised; eff. 5-8-93..................2893 133.140 (c) revised; eff. 5-8-93....................................2893 133.141 (d) introductory text revised; eff. 5-8-93..................2893 133.144 (d) introductory text revised; eff. 5-8-93..................2893 133.146 (e) introductory text revised; eff. 5-8-93..................2893 133.147 (e) revised; eff. 5-8-93....................................2893 133.148 (f) introductory text revised; eff. 5-8-93..................2893 133.149 (d) introductory text revised; eff. 5-8-93..................2893 133.150 (f) introductory text revised; eff. 5-8-93..................2893 133.152 (d) introductory text revised; eff. 5-8-93..................2893 133.153 (d) introductory text revised; eff. 5-8-93..................2893 133.154 Revised; eff. 5-8-93........................................2893 [[Page 281]] 133.155 (d) introductory text revised; eff. 5-8-93..................2893 133.156 (d) introductory text revised; eff. 5-8-93..................2893 133.158 Revised; eff. 5-8-93........................................2894 133.160 (d) introductory text revised; eff. 5-8-93..................2894 133.162 (d) introductory text revised; eff. 5-8-93..................2894 133.164 (d) introductory text revised; eff. 5-8-93..................2894 133.165 (e) revised; eff. 5-8-93....................................2894 133.167 Introductory text revised; eff. 5-8-93......................2894 133.168 (a) introductory text revised; eff. 5-8-93..................2894 133.169 (g) revised; eff. 5-8-93....................................2894 133.170 (a) introductory text revised; eff. 5-8-93..................2894 133.171 Introductory text revised; (f) removed; eff. 5-8-93.........2894 133.173 (h) revised; eff. 5-8-93....................................2894 133.174 (a) introductory text revised; eff. 5-8-93..................2894 133.175 Revised; eff. 5-8-93........................................2894 133.176 (a) introductory text revised; eff. 5-8-93..................2894 133.178 (d) revised; eff. 5-8-93....................................2894 133.179 (i) revised; eff. 5-8-93....................................2895 133.180 (a) introductory text revised; eff. 5-8-93..................2895 133.181 (d) introductory text revised; eff. 5-8-93..................2895 133.182 (f) added; eff. 5-8-93......................................2895 133.183 (f) introductory text revised; eff. 5-8-93..................2895 133.184 (d) introductory text revised; eff. 5-8-93..................2895 133.185 (d) introductory text revised; eff. 5-8-93..................2895 133.186 (d) revised; eff. 5-8-93....................................2895 133.187 (g) added; eff. 5-8-93......................................2895 133.188 (g) added; eff. 5-8-93......................................2895 133.189 (e) added; eff. 5-8-93......................................2895 133.190 (d) introductory text revised; eff. 5-8-93..................2895 133.191 Revised; eff. 5-8-93........................................2895 133.193 (a) revised; eff. 5-8-93....................................2895 133.195 (d) introductory text; eff. 5-8-93..........................2895 135 Technical correction....................................17103, 17105 135.110 (f) revised; eff. 5-8-93....................................2896 135.115 (d) revised; eff. 5-8-93....................................2896 135.120 (a) introductory text; eff. 5-8-93..........................2896 135.130 (e) revised; eff. 5-8-93....................................2896 135.140 (i) revised; eff. 5-8-93....................................2896 135.160 (a) revised; eff. 5-8-93....................................2876 136 Technical correction...........................................17103 136.110 (f) revised; eff. 5-8-93....................................2877 137 Technical correction...........................................17103 137.105 (b)(1) revised; eff. 5-8-93.................................2877 137.155 Revised; eff. 5-8-93........................................2877 137.160 Revised; eff. 5-8-93........................................2877 137.165 Introductory text revised; eff. 5-8-93......................2877 137.170 (a) revised; eff. 5-8-93....................................2877 137.175 Introductory text revised; eff. 5-8-93......................2877 137.180 (b) revised; eff. 5-8-93....................................2877 137.185 Introductory text revised; eff. 5-8-93......................2877 137.200 (b)(1) revised; eff. 5-8-93.................................2877 137.205 Revised; eff. 5-8-93........................................2877 137.225 Revised; eff. 5-8-93........................................2877 137.235 (c) added; eff. 5-8-93......................................2877 137.260 (c) added; eff. 5-8-93......................................2878 137.270 (c) added; eff. 5-8-93......................................2878 137.305 (b)(1) revised; eff. 5-8-93.................................2878 137.350 (g) added; eff. 5-8-93......................................2878 139 Technical correction...........................................17103 139.110 (g) added; eff. 5-8-93......................................2878 139.115 (a) introductory text; eff. 5-8-93..........................2878 139.117 (e) revised; eff. 5-8-93....................................2878 139.120 (a) introductory text revised; eff. 5-8-93..................2878 139.121 (a) introductory text revised; eff. 5-8-93..................2878 139.122 (a) introductory text revised; eff. 5-8-93..................2878 139.125 (a) introductory text revised; eff. 5-8-93..................2878 139.135 (a) revised; eff. 5-8-93....................................2878 139.138 (a) introductory text revised; eff. 5-8-93..................2878 139.140 (a) introductory text revised; eff. 5-8-93..................2878 139.150 (i) added; eff. 5-8-93......................................2879 139.155 (a) introductory text revised; eff. 5-8-93..................2879 139.160 (a) revised; eff. 5-8-93....................................2879 139.165 (a) revised; eff. 5-8-93....................................2879 139.180 (a) revised; eff. 5-8-93....................................2879 145 Technical correction...........................................17103 145.110 (a)(4) revised; eff. 5-8-93.................................2879 145.115 (a)(4)(iv) revised; eff. 5-8-93.............................2879 145.116 (b)(2) revised; eff. 5-8-93.................................2879 145.120 (a)(5)(iv) revised; eff. 5-8-93.............................2879 145.125 (a)(4)(iv) revised; eff. 5-8-93.............................2879 [[Page 282]] 145.126 (b)(2) revised; eff. 5-8-93.................................2879 145.130 (d)(4) revised; eff. 5-8-93.................................2879 145.131 (b)(2) revised; eff. 5-8-93.................................2880 145.134 (f) added; eff. 5-8-93......................................2880 145.135 (a)(4)(iv) revised; eff. 5-8-93.............................2880 145.136 (b)(2) revised; eff. 5-8-93.................................2880 145.140 (d)(4) revised; eff. 5-8-93.................................2880 145.145 (a)(4)(iii) revised; eff. 5-8-93............................2880 145.170 (a)(4)(iv) revised; eff. 5-8-93.............................2880 145.171 (b)(2) revised; eff. 5-8-93.................................2880 145.175 (a)(4)(iv) revised; eff. 5-8-93.............................2880 145.176 (b)(2) revised; eff. 5-8-93.................................2880 145.180 (a)(5)(iii) revised; eff. 5-8-93............................2880 145.181 (b)(2) revised; eff. 5-8-93.................................2880 145.185 (a)(4)(iv) revised; eff. 5-8-93.............................2880 145.190 (c)(4) revised; eff. 5-8-93.................................2880 146 Technical correction...........................................17103 146.113 (h) added; eff. 5-8-93......................................2881 146.114 (a)(3)(ii) revised; eff. 5-8-93.............................2881 146.120 (c) revised; eff. 5-8-93....................................2881 146.121 (f) added; eff. 5-8-93......................................2881 146.126 (c) revised; eff. 5-8-93....................................2881 146.132 (a)(3)(iii) revised; 5-8-93.................................2881 146.140 (g) added; eff. 5-8-93......................................2881 146.141 (f) added; eff. 5-8-93......................................2881 146.145 (f) added; eff. 5-8-93......................................2881 146.146 (g) added; eff. 5-8-93......................................2881 146.148 (a) revised; eff. 5-8-93....................................2881 146.150 (a) revised; eff. 5-8-93....................................2881 146.152 (d) revised; 5-8-93.........................................2881 146.153 (a) revised; eff. 5-8-93....................................2881 146.154 (d) revised; eff. 5-8-93....................................2882 146.185 (a)(3) revised; eff. 5-8-93.................................2882 146.187 (d) added; eff. 5-8-93......................................2882 150 Technical correction...........................................17103 150.110 (e)(1) introductory text revised; (e)(2)(ii) removed; eff. 5-8-93......................................................2882 150.140 (e)(2) introductory text revised; eff. 5-8-93...............2882 150.141 (h) added; eff. 5-8-93......................................2882 150.160 (e)(2) introductory text revised; eff. 5-8-93...............2882 150.161 (h) added; eff. 5-8-93......................................2882 152 Technical correction...........................................17103 152.126 (a)(4)(i) revised; eff. 5-8-93..............................2882 155.3 Regulation at 48 FR 3954 effective date confirmed............16771 155.120 (a)(5) revised; eff. 5-8-93.................................2882 155.130 (a)(5) revised; eff. 5-8-93.................................2882 155.131 (a)(1) revised; eff. 5-8-93.................................2882 155.170 (a)(4) revised; eff. 5-8-93.................................2882 155.172 (a) introductory text revised; eff. 5-8-93..................2883 155.190 (a)(6) revised; eff. 5-8-93................................17103 155.191 (a)(3)(iv) revised; eff. 5-8-93.............................2883 Regulation at 48 FR 3954 and 49 FR 15073 effective date confirmed..........................................................16771 (a)(3)(iv) corrected...........................................17104 155.192 Removal at 48 FR 3956 effective date confirmed.............16771 155.194 (a)(3)(iii) revised; eff. 5-8-93............................2883 Regulation at 48 FR 3956 and 49 FR 15073 effective date confirmed..........................................................16771 155.200 (h) revised; eff. 5-8-93....................................2883 155.201 (a)(4)(ii) revised; eff. 5-8-93.............................2883 156 Technical correction...........................................17103 156.3 (Subpart A) Regulation at 48 FR 3956 effective date confirmed..................................................16771 156.145 (a)(2)(ii) revised; eff. 5-8-93.............................2883 Regulation at 48 FR 3957 effective date confirmed..............16771 156.147 Removal at 48 FR 3958 effective date confirmed.............16771 158 Technical correction...........................................17103 158.170 (a)(4) revised; eff. 5-8-93.................................2883 160 Technical correction...........................................17103 160.105 (e) added; eff. 5-8-93......................................2883 160.110 (d) added; eff. 5-8-93......................................2883 160.115 Existing text designated as (a); (b) added; eff. 5-8-93.....2883 160.140 (c) added; eff. 5-8-93......................................2883 160.145 (f) added; eff. 5-8-93......................................2883 160.150 (c) added; eff. 5-8-93......................................2883 160.180 Existing text designated as (a); (b) added; eff. 5-8-93.....2883 160.185 (e) added; eff. 5-8-93......................................2883 160.190 Existing text designated as (a); (b) added; eff. 5-8-93.....2884 161 Technical correction...........................................17103 161.145 (a)(4) added; eff. 5-8-93...................................2884 161.170 (a)(5)(iii) revised; eff. 5-8-93............................2884 161.173 (a)(5)(ix) revised; eff. 5-8-93.............................2884 161.175 (i) added; eff. 5-8-93......................................2884 [[Page 283]] 161.190 (a)(6)(ii) through (viii) and (8)(vi) revised; (a)(6)(ix) removed; eff. 5-8-93........................................2884 163 Technical correction...........................................17103 Revised........................................................29529 163.110 (c) added; eff. 5-8-93......................................2884 163.111 (c) added; eff. 5-8-93......................................2884 163.112 (c) added; eff. 5-8-93......................................2885 163.113 Revised; eff. 5-8-93........................................2885 163.114 Revised; eff. 5-8-93........................................2885 163.117 (a) revised; eff. 5-8-93....................................2885 163.123 (i) added; eff. 5-8-93......................................2885 163.130 (f) added; eff. 5-8-93......................................2885 163.135 (c) added; eff. 5-8-93......................................2885 163.140 (c) added; eff. 5-8-93......................................2885 163.145 (c) added; eff. 5-8-93......................................2885 163.150 (d) added; eff. 5-8-93......................................2885 163.153 (c) added; eff. 5-8-93......................................2885 163.155 (c) added; eff. 5-8-93......................................2885 164 Technical correction...........................................17103 164.110 (e) introductory text and (f) revised; (e)(3) and (4) removed; eff. 5-8-93........................................2885 164.150 (e) revised; eff. 5-8-93....................................2886 166 Technical correction...........................................17103 166.110 (d) revised; eff. 5-8-93....................................2886 (a) introductory text amended; (b)(4) revised..................21649 168 Technical correction....................................17103, 17105 168.110 (b) revised; eff. 5-8-93....................................2886 168.111 (c) revised; eff. 5-8-93....................................2886 168.130 (d) revised; eff. 5-8-93....................................2886 168.140 (d) revised; eff. 5-8-93....................................2896 168.160 (d) revised; eff. 5-8-93....................................2886 168.180 (d)(1) revised; eff. 5-8-93.................................2886 169 Technical correction...........................................17103 169.115 (e) revised; eff. 5-8-93....................................2886 169.140 (f) revised; eff. 5-8-93....................................2886 169.150 (g) revised; eff. 5-8-93....................................2886 169.175 (c) added; eff. 5-8-93......................................2886 169.176 (a) revised; eff. 5-8-93....................................2886 169.177 (a) revised; eff. 5-8-93....................................2886 169.178 (a) revised; eff. 5-8-93....................................2886 169.179 (d) added; eff. 5-8-93......................................2887 169.180 (a) revised; eff. 5-8-93....................................2887 169.181 (a) revised; eff. 5-8-93....................................2887 169.182 (a) revised; eff. 5-8-93....................................2887 Chapter I Technical correction.....................................17085 172 Authority citation revised..............................48598, 52221 172.120 (b)(1) table amended.......................................52222 172.133 Introductory text, (b) and (c)(2) revised...................6091 172.490 (a) ameended...............................................17098 172.804 (c)(10) and (d) revised....................................19771 (c)(5)(ii) and (6) revised; (c)(8), (11) and (12) removed......21097 (d) revised....................................................21098 (c)(23) added..................................................21099 (c)(18) revised................................................48598 172.892 (d) table amended..........................................21100 175 Authority citation revised.....................................39655 175.105 (c)(5) table amended.........................21256, 21257, 39656 176 Authority citation revised.....................................51996 Authority citation corrected...................................65284 176.170 (a)(5) table amended................................21103, 51996 176.180 (b)(2) table amended.......................................60112 177 Authority citation revised.....................................48599 177.1060 (e) amended...............................................17098 177.1395 (b)(4) table amended......................................32610 177.1500 (b) table amended..........................................2977 Technical correction............................................8820 (a)(13) revised; (b) table amended.............................32610 177.1520 (c) table ammended........................................17098 (d)(3)(ii) introductory text revised; (d)(3)(ii)(e) through (i) added..........................................................21258 177.1810 (b) table amended.........................................65546 177.2600 (c)(4)(ii)(b) amended.....................................60554 177.2910 Introductory text revised; (a)(3) added...................48599 178 Authority citation revised.....................................37855 178.1010 (b)(41) corrected.........................................17099 (b)(43) added; (c)(19) amended.................................57555 178.2010 (b) table amended..................................17515, 37855 178.3010 Table amended.............................................64895 178.3130 (b) table amended.........................................57556 178.3297 (e) table amended.........................................17514 (c) and (e) table amended; (d) revised.........................67323 178.3400 (c) table amended.........................................26687 178.3770 (a)(2), (3), (b)(2), (3), (d)(2) and (3) amended..........17512 178.3910 (b)(2) table amended......................................17513 184.1685 (a)(4) added..............................................27202 Technical correction...........................................30220 186.1551 (a) amended...............................................17099 189.220 (a) amended................................................17099 201 Authority citation revised.....................................45201 201.319 Added......................................................45201 206 Added; eff. 9 13 95............................................47958 207.25 (c) added; eff. 9 13 95.....................................47959 207.37 (a)(1)(xi) added; eff. 9 13 95..............................47959 210.3 (b)(22) added; eff. 8 3 94...................................41353 211.122 (f) revised; (g) redesignated as (h); new (g) added; eff. 8 3 94.....................................................41353 [[Page 284]] 211.125 (c) revised; eff. 8 3 94...................................41354 211.130 (b), (c) and (d) redesignated as (c), (d) and (e); new (b) added; eff. 8 3 94.........................................41354 291 Authority citation revised.......................................498 291.501 Revised; interim...........................................38709 291.505 (d)(1)(i), (iii), (iv), (2)(i), (3)(v), (D), (4)(i)(B)(2), (5)(ii), (6)(iv)(B)(6), (v)(A)(1), (3), (C), (8)(i) introductory text, (E), (9)(i) introductory text and (F) amended; (a)(2) and (d)(8)(i)(F) revised; (a)(10), (b)(1)(v), (2)(vi), (d)(4)(i)(C) and (7) added...............498 291.505 (d)(1)(i)(C), (iii)(B)(1), (C), (3)(i), (13)(i) and (f)(2)(viii) amended; (d)(6)(ii) removed; (k) redesignated as (l); (b)(2)(v), (vi)(D), (c)(4)(i), (ii), (d)(1)(ii), (iv), (6) heading, (6)(i) heading, (h)(1) and new (l) revised; (d)(1)(iii)(B)(6), (4)(v) and new (k) added.......38709 310 Authority citation revised..............................46745, 54462 310.201 (a)(29) removed; eff. 9-23-94..............................49898 310.530 Added......................................................47610 310.531 Added; eff. 5-16-94........................................60336 310.536 Added......................................................46754 310.538 Added......................................................47605 310.544 Added......................................................31241 310.545 (a)(8) and (18) text redesignated as (a)(8)(i) and (18)(i); new (a)(8)(i) heading, (10)(v), (vi) and (vii), (18)(i) heading, (ii), (iii), (vi), (22)(ii), (23), (24), (25) and (d)(11) added; (d) introductory text and (1) revised....................................................27641 (a)(19) removed................................................31241 (a)(22)(iii) and (d)(12) added; (d) introductory text revised 46745 (a)(26), (d)(13) and (14) added; (d) introductory text revised; eff. 9-2-94...............................................46748 (a)(13) removed................................................46754 (a)(11) removed................................................47605 (a)(22)(iv) and (d)(15) added; (d) introductory text revised; eff. 9-23-94.......................................................49898 (a)(8)(iii) and (d)(21) added; (d) introductory text revised; eff. 4-21-94.......................................................54455 (a)(18)(ii) amended; (d)(11) revised; (d)(22) added; eff. 10- 21-94..............................................................54462 (a)(5) removed; eff. 5-16-94...................................60337 312.57 (c) revised.................................................25926 314 Authority citation revised.....................................47351 Technical correction............................................4078 314.50 Introductory text and (h)(2) revised; (d)(1)(ii) redesignated as (d)(1)(ii)(a); (d)(1)(ii)(b), (c), (d)(1)(v), (h)(3) and (4) added............................47351 314.54 (a)(1)(i) revised; (a)(2) amended; (a)(4) added.............47351 314.60 (c) added...................................................47352 314.70 (a) revised.................................................47352 (b)(2)(xi), (xii) and (d)(9) added; eff. 9-13-95...............47959 314.71 (b) revised.................................................47352 314.94 Introductory text amended; (a)(9)(i) and (d)(4) revised; (d)(5) added...............................................47352 314.96 (b) redesignated as (c); new (b) added......................47352 314.125 (b)(17) revised............................................25926 314.127 (b) revised................................................25927 314.150 (b)(9) revised.............................................25927 314.440 (a)(1) and (2) amended; (a)(4) added.......................47352 316.10 (b)(10) corrected............................................6167 316.27 (a)(2)(ii) corrected.........................................6167 320.31 (c) revised; (d) added; (e) and (f) removed.................25927 320.38 Revised.....................................................25927 320.63 Revised.....................................................25928 330.3 Added; eff. 9-13-95..........................................47959 331.30 (d) introductory text revised; (h) added; eff. 8-26-94......45208 333.201--333.280 (Subpart C) Added; eff. 9-23-94...................49898 341.74 (c)(4)(v) and (vi) added; eff. 10-20-94.....................54236 341.76 (c)(4) revised; eff. 10-20-94...............................54242 347 Added; eff. 10-21-94...........................................54462 358.601--358.650 (Subpart G) Added; eff. 12-14-94..................65455 430.4 (a)(64) added................................................26652 (a)(65) added..................................................26656 (a)(66) added..................................................26659 (a)(67) added..................................................26663 (a)(68) added..................................................26666 430.5 (a)(99) and (b)(101) added...................................26652 (a)(100) and (b)(102) added....................................26656 (a)(101) and (b)(103) added....................................26659 (a)(102) and (b)(104) added....................................26663 (a)(103) and (b)(105) added....................................26666 430.6 (b)(101) added...............................................26653 (b)(102) added.................................................26656 [[Page 285]] (b)(103) added.................................................26659 (b)(104) added.................................................26663 (b)(105) added.................................................26666 436.215 (b) table amended; (c)(13) added...........................26653 (b) table amended; (c)(14) added...............................26656 (b) table amended; (c)(15) added...............................26660 (b) table amended; (c)(16) added...............................26667 436.368 Added......................................................26660 441.220 Redesignated as 441.220b...................................26669 Added..........................................................26670 441.220a Added.....................................................26670 441.220b Redesignated from 441.220.................................26669 442.80 Added.......................................................26660 442.180 Added......................................................26661 442.180a Added.....................................................26661 442.180b Added.....................................................26661 443 Added..........................................................26667 444.380e Added.....................................................26671 450.30 Added.......................................................26664 450.230 Added......................................................26665 452.50 Added.......................................................26653 452.60 Added.......................................................26657 452.150 Added......................................................26654 452.160 Added......................................................26658 510 Authority citation revised.....................................44611 510.515 Introductory text, (b)(7)(i) and (c) table amended; (b)(7)(i)(c) removed.......................................30119 510.600 (c)(1) table and (2) table amended...................4316, 5607, 26523, 30118, 36135, 37855, 38971, 44611, 47056, 47377, 59169, 59947, 63890 514 Authority citation revised.....................................51011 514.210 Removed....................................................51011 520.88d Heading corrected..........................................18304 520.90b (d)(2)(ii) correctly designated............................18304 520.90c (b) amended................................................61016 520.90d (b) amended................................................61016 520.90e (b) amended................................................61016 520.90f (b) amended................................................61016 520.182 (b) amended.................................................5608 520.240 Removed....................................................41025 520.445b (b) amended; (b) heading and (d)(4) introductory text revised....................................................61015 520.580 (b)(1) amended.............................................41025 520.1448a (a)(2) amended...........................................26523 520.1485 Added.....................................................38972 520.1660d (a) and (b) revised; (e)(1)(iii), (iv), (v) and (2) added......................................................42854 (a)(5) added; (b)(3) revised; (e)(1)(ii)(A)(3), (B)(3) and (C)(3) amended.....................................................43794 520.1720c (b) amended..............................................29777 520.1806 (b) amended...............................................44611 520.1840 (c)(3) amended............................................26523 520.1870 (c)(1)(i) revised.........................................42853 520.1871 Added.....................................................58652 520.1196 Added......................................................8542 520.1445 (c)(2) revised.............................................5608 520.1870 (a) and (c)(2)(ii) revised.................................7864 520.2041 (b) amended...............................................44611 520.2042 (b) amended...............................................44611 520.2088 (c) added.................................................65664 520.2089 Added.....................................................65665 520.2158a (d)(1) and (2) revised; (d)(3) removed...................47211 520.2220a Heading, (a), (b) and (e) introductory text revised.......6092 520.2345d (e)(1)(iii)(A), (B), (C), (3)(iv)(A), (B) and (C) revised....................................................33331 520.2455 Heading revised; (d)(2)(i) and (ii) amended...............14313 520.2456 Added.....................................................14313 520.2613 Added.....................................................36135 522.90b (d)(2)(ii) correctly designated............................18304 522.575 Added........................................................500 522.820 Revised....................................................43795 522.1002 Redesignated from 522.1822 and revised....................47377 522.1079 (c)(2) and (3) revised....................................52222 522.1696a (b)(1) amended...........................................65285 522.1696b (d) introductory text revised............................11964 522.1822 Redesignated as 522.1002..................................47377 522.1870 (c)(1)(ii) revised........................................42853 522.2100 (c), (d) and (e) added....................................57556 522.2112 Added.....................................................59947 522.2220 (a)(2) revised............................................38972 522.2670 Revised....................................................8543 524.1044g Added....................................................38973 524.2101 (c) amended...............................................41025 526.464b (c) introductory text amended.............................61016 526.1696a (f) removed................................................500 526.1810 Added.....................................................58486 529.1030 (c)(1)(iii) and (2)(iii) added............................59169 529.1044a (b) amended..............................................14314 [[Page 286]] 529.1186 (b) amended...............................................17346 556.230 (a) and (b) revised........................................43795 556.500 (e) added..................................................42855 556.515 Added......................................................58486 556.610 Revised....................................................47211 558 Technical correction...........................................17346 558.4 (d) table amended.....................................30119, 58653 558.15 (g)(1) table and (2) table amended..........................17515 (g)(1) table amended...........................................30119 (g)(2) table amended...........................................30120 558.55 (d)(2) table amended........................................30120 558.58 (d)(1) table amended........................................30120 558.95 (b)(1)(xi)(b) and (xii)(b) amended..........................47056 (a)(1) revised; (b)(4) redesignated as (b)(5); new (b)(4) added..............................................................54287 558.258 (c)(3)(iv)(C) amended......................................47973 558.274 (c)(1) table amended.......................................30120 558.300 Added......................................................58653 558.311 (b)(4) and (6) revised; (e)(3) redesignated as (e)(4); new (e)(3) added...............................................43560 (e)(2)(i) table amended........................................47973 558.355 (f)(3)(ix) amended..........................................4316 (d)(7)(vi) added...............................................17516 (b)(13) revised................................................53883 558.460 (c)(1) table amended; (c)(2)(vii) and (viii) removed; (c)(2)(ix) and (x) redesignated as (c)(2)(vii) and (viii) 30120 558.550 (a) amended................................................47056 558.625 (b)(54) amended............................................63890 573.750 Added......................................................59170 573.920 Regulations at 52 FR 10888, 21001, and 54 FR 14215 stayed 47973 579.22 (b) table revised...........................................18148 601 Technical correction............................................4078 630.13 (b)(4) amended..............................................19609 804 Opportunity for comment........................................46514 Added..........................................................46519 807 Opportunity for comment........................................46514 Heading and authority citation revised.........................46522 807.3 (d)(2) and (g) revised; (e)(3) and (4) amended; (e)(5) added 46522 807.20 (a)(4) revised; (c) and (d) added...........................46522 807.21 Revised.....................................................46522 807.22 (a) and (c) revised.........................................46522 807.25 (b) revised.................................................46523 807.65 (e) revised; (g) removed....................................46523 821 Opportunity for comment........................................43442 Revised........................................................43447 Authority citation revised.....................................43455 Regulation at 58 FR 43447 and 43455 comment period extended....48599 Technical correction...........................................52440 821.20 (b)(1) table and (c) table amended..........................43455 864.5680 (b) revised; (c) removed..................................51571 874.4490 Revised...................................................29534 878 Authority citation revised.....................................57558 878.5030 Added.....................................................57558 888.3358 Added......................................................3228 890.3450 Removed...................................................29535 900 (Subchapter I) Added; interim..................................67562 900.10--900.14 (Subpart B) Added; interim..........................67570 1020 Authority citation revised....................................26396 1020.30 Revised; eff. in part 5-3-94...............................26396 1020.31 Revised; eff. in part 5-3-94...............................26401 (c)(2) corrected...............................................31067 1020.32 Revised....................................................26404 1220.40 (a) revised................................................64137 1270 Added; interim................................................65520 Chapter II 1301 Effective date paragraph at 58 FR 31172 corrected.............31907 1301.11 Revised....................................................15274 1301.22 (b)(6) revised.............................................31175 1301.24 (b) and (c) introductory text revised......................31175 1304 Effective date paragraph at 58 FR 31172 corrected.............31907 1304.02 (f) through (i) redesignated as (g) through (j); new (f) added......................................................31175 1304.03 (e) through (g) redesignated as (f) through (h); new (e) added; new (h) revised.....................................31175 1308.11 (d)(3) through (28) redesignated as (d)(4) through (29); new (d)(3) added............................................4317 (f)(1) through (4) redesignated as (f)(2) through (5); new (f)(1) added........................................................4318 (g)(5) added...................................................13534 Regulation at 57 FR 18824 eff. date extended to 11 1 93........25934 (b)(4) revised.................................................43796 Regulation at 57 FR 43401 eff. date extended to 3 21 94........44611 [[Page 287]] (g)(3) removed; (f)(3), (4), (5), (g)(4) and (5) redesignated as (f)(4), (5), (6), (g)(3) and (4); new (f)(3) added..............53406 1308.12 (c)(11) through (25) redesignated as (c)(12) through (26); new (c)(11) added..........................................43796 1308.14 (c)(48) added...............................................7187 1308.24 (i) table revised..........................................17107 1308.26 (a) table amended..........................................15088 1308.34 Table amended; interim.....................................16773 Table amended; interim.........................................34708 Regulation at 58 FR 16773 confirmed............................34709 Regulation at 58 FR 34708 confirmed............................49924 1311.11 Revised....................................................15274 Chapter III 1403 Appendix A corrected..........................................26185 1994 21 CFR 59 FR Page Chapter I Chapter I Nomenclature change......................................14366 5 Clarification....................................................15049 Authority citation revised.....................................35849 5.20 (h) redesignated as (i); new (h) added........................14549 5.22 (a)(8) revised................................................42491 5.23 (a) introductory text revised; (a)(10)(i) through (vii) added 37419 5.25 (a)(4) revised................................................42491 5.26 Introductory text, (a), (c), (d), (e) and (h) revised; (i) added.......................................................5317 (e) revised....................................................42491 5.30 (a)(1) and (c)(2) revised.....................................42491 5.31 (g) added.....................................................31138 (c)(2) and (e)(1) revised......................................42491 5.35 (b)(3) added..................................................47799 5.37 (a)(3)(i), (ii), and (iii) revised; (a)(3)(iv) added..........42491 5.61 (a), (b)(1), (2), (c)(1), (d), (e), (f)(1) and (g) revised....42492 5.62 Heading revised; existing text designated as (a); (b) added 5317 Revised........................................................42492 5.66 Revised.......................................................42492 5.80 (a)(1)(i) amended; (d) redesignated as (f); (c) introductory text, (1)(i), (ii), (iii) and new (f) introductory text revised; (c)(1)(iv), new (d) and (e) added.................17094 (e) revised....................................................33431 5.85 Added.........................................................35849 5.110 (a) amended..................................................14363 7.42 (b)(3) amended................................................14363 10.3 (a) amended...................................................14363 10.20 (f) amended..................................................14363 10.30 (b) amended..................................................14364 10.33 (b) amended..................................................14364 10.35 (b) amended..................................................14364 10.85 (b) amended..................................................14364 12.45 (a) amended..................................................14364 16 Workshop........................................................29950 20.41 (b)(5), (c) and (d) removed....................................533 20.42 Revised........................................................533 20.43 Revised........................................................534 20.53 Amended........................................................535 20.61 (a) revised; (d), (e) and (f) added............................535 20.64 Heading and (a) revised; (b), (c) introductory text, (d) introductory text and (e) amended............................536 20.81 (a)(3) amended.................................................536 20.85 Amended........................................................536 20.87 (a) revised....................................................536 20.100 (c)(7), (14), (16) and (17) revised; (c)(35) through (40) added........................................................536 25.42 (b)(3)(v) amended............................................14364 58 Authority citation revised......................................13200 58.210 (a) amended.................................................13200 60.20 (b) amended..................................................14364 60.24 (a) amended..................................................14364 60.26 (b)(2) amended...............................................14364 73 Authority citation revised......................................10578 73.200 (a)(2), (b) and (c) revised; eff. 4-7-94....................10578 Regulation at 59 FR 10578 effective date confirmed.............28765 74 Authority citation revised.......................................7636 74.1101 (b) and (c) revised.........................................7638 Regulation at 59 FR 7638 eff. date corrected to 3 19 94.........8507 Regulations at 59 FR 7638 and 8507 eff. date confirmed as 3- 19-94..............................................................25322 74.1205 (c)(2) revised.............................................40805 Regulation at 59 FR 40805 eff. date confirmed as 9-12-94.......53584 74.1340 (b) revised.................................................7636 [[Page 288]] Regulation at 59 FR 7636 eff. date corrected to 3 19 94.........8507 Regulation at 59 FR 7635 eff. date confirmed as 3-19-94........24643 74.1705 (a)(2) redesignated as (a)(3); new (a)(2) added; (b) revised; (c)(2) and (3) amended............................60897 Regulation at 59 FR 60897 eff. date corrected to 12-30-94......61929 74.2101 (b) and (c) revised.........................................7638 Regulation at 59 FR 7638 eff. date corrected to 3 19 94.........8507 Regulations at 59 FR 7638 and 8507 eff. date confirmed as 3- 19-94..............................................................25322 74.2205 (b) revised................................................40805 Regulation at 59 FR 40805 eff. date confirmed as 9-12-94.......53584 74.2340 (b) revised.................................................7636 Regulation at 59 FR 7636 eff. date corrected to 3 19 94.........8507 Regulation at 59 FR 7636 eff. date confirmed as 3-19-94........24643 74.2705 (b) introductory text redesignated as (b)(1); (b)(2) added; (c) revised.........................................60898 Regulation at 59 FR 60898 eff. date corrected to 12-30-94......61929 74.3602 Regulation at 58 FR 60109 eff. date confirmed as 12 16 93 3998 (b)(2)(iv) added; eff. 4 14 94.................................11720 Regulation at 59 FR 11720 eff. date confirmed..................26420 80.10 (a) and (b) revised; (c), (d) and (e) redesignated as (d), (e) and (f); new (c) added.................................60899 Chapter I Nomenclature change......................................14366 100.100 (Subpart F) Regulation at 58 FR 27933 removed................537 101 Date of application..............................................350 Clarification..................................................15049 Notice.........................................................28480 101.9 (d)(3)(ii), (h)(2) and (j)(6) revised; eff. 7-5-95.............371 Regulation at 59 FR 371 eff. date corrected to 7-1-95..........24039 (c)(1)(i) revised..............................................62317 101.12 (b) Table 2 amended; eff. 7-5-95..............................371 Regulation at 59 FR 371 eff. date corrected to 7-1-95; Table 2 amended; eff. 7-1-95...............................................24039 101.13 (a), (i) introductory text, (j)(1)(i)(A), (B) and (n) revised; (b)(5) added; (c) amended; eff. 7-1-95..............393 (j)(1)(i)(B) corrected.........................................15051 101.14 (a)(2), (b)(3)(i), (d)(1), (3), (e) introductory text, (6) and (g) revised; (a)(4) added; eff. 7 5 94...................425 Regulation at 59 FR 425 eff. date corrected to 7 1 94; (e)(6) corrected..........................................................15050 101.36 Added; eff. 7 5 95............................................373 Regulation at 59 FR 371 eff. date corrected to 7-1-95; (b)(4) introductory text, (vi), (c)(10) and (g) amended; eff. 7-1-95......24039 101.54 (a)(3), (b)(1), (c)(1) and (e)(1) introductory text revised; eff. 5 8 94.........................................394 (b)(1) corrected...............................................15051 101.60 (c)(4) and (5) redesignated as (c)(5) and (6); (a)(2), (3) and new (c)(5) introductory text revised; (a)(4) and new (c)(4) added; eff. 7 1 95....................................394 101.61 (a)(3) revised; eff. 7 1 95...................................394 101.62 (a)(2) and (3) revised; (a)(4) added; eff. 7 1 95.............394 101.65 (a)(3), (b)(3) and (4) revised; eff. 7 95.....................394 (d)(2), (3) and (4) added......................................24249 (d)(2)(ii)(A), (C)(1), (iv), (3)(ii)(A), (C)(1) and (iii) corrected..........................................................50828 101.70 (f) amended; eff. 7 5 94......................................425 Regulation at 59 FR 426 eff. date corrected to 7 1 94..........15050 101.71 (c) removed; (d), (e) and (f) redesignated as (c), (d) and (e); eff. 7 1 94.............................................434 Introductory text revised; eff. 7 1 94...........................437 101.79 Added; eff. 7 1 94............................................434 101.108 (c) amended................................................14364 103.35 (d)(1)(i) table amended; (d)(3) introductory text revised; (d)(3)(i) and (v) added....................................26937 (d)(1)(i) table, (i) table and (ii) table amended; (d)(3) introductory text, (v) introductory text and (vi) revised; (d)(3)(iii), (iv), (v)(A) through (F) and (vii) added; eff. 5-30- 95.................................................................61535 [[Page 289]] 105 Clarification..................................................15049 109 Authority citation revised......................................1641 109.16 Added; eff. 7 13 94..........................................1641 109.30 (b), (c) and (d) amended....................................14364 130 Clarification..................................................15049 130.17 (c) introductory text amended...............................15051 131 Authority citation revised.....................................17691 131.130 (a) revised................................................17691 Regulation at 59 FR 17691 confirmed............................32078 135 Authority citation revised.....................................47079 135.110 (a)(1) and (b) revised; (d), (e) and (f) redesignated as (e), (f) and (g); new (d) and (f)(7) added; eff. 9-14-95 47079 Regulation at 59 FR 47079 effective date confirmed.............64571 135.115 (a) revised; (c) text redesignated as (c)(1); new (c)(2) added; eff. 9-14-95........................................47080 Regulation at 59 FR 47080 effective date confirmed.............64571 135.120 Removed; eff. 9-14-95......................................47080 Regulation at 59 FR 47080 effective date confirmed.............64571 135.125 Removed; eff. 9-14-95......................................47080 Regulation at 59 FR 47080 effective date confirmed.............64571 155.190 (a)(3)(iv) amended.........................................15051 155.200 (g) amended................................................15052 166 Authority citation revised.....................................26939 166.110 (a) introductory text heading and (c) heading added; (a)(1) revised; (b) heading and (d) heading amended........26939 172.133 Introductory text, (b) and (c)(2) revised...................5319 172.320 (b)(1) amended.............................................14550 172.800 (c)(9), (10) and (11) added................................61540 (c)(1) revised; (c)(2) removed.................................61543 (c)(8) added...................................................61545 172.811 (b) revised................................................24924 172.841 (b), (c), and (d) redesignated as (c), (d), and (e); new (b) added; new (c) revised.................................37421 172.888 (a) revised................................................10986 173.21 Added.......................................................15623 173.170 Added......................................................26711 173.357 (a)(2) table amended.......................................36937 175.105 (c)(5) table amended.......................................47080 175.300 (b)(3)(xxxiii) amended......................................8854 (d) Table 2 corrected; CFR correction..........................58775 (b)(3)(xxxvii) added...........................................63894 176.170 (a)(5) table amended...................2293, 14550, 33195, 48391 177.1345 Introductory text revised; (d) added......................62318 177.1520 (a)(3)(i)(e) added; (c) table amended.....................10987 (b) table amended.......................................26422, 43730 177.1580 (b) table amended.........................................43731 177.1610 (a) amended; (b) added....................................14550 177.2465 Added......................................................5948 177.2550 (a)(5) added; (d)(1) revised...............................9925 177.2600 (c)(4)(i) amended.........................................46171 178.2010 (b) table amended...............2735, 8855, 33196, 45973, 62319 (b) table corrected............................................54130 178.3295 Table amended......................................13650, 25323 178.3297 (e) table amended......................3654, 5705, 10065, 10066 178.3570 (a)(3) table amended......................................14551 179.45 (b)(4)(i), (6)(i), (d)(2)(ii), (iii) and (iv) amended.......14551 182.1033 Removed...................................................63895 182.1195 Removed...................................................63895 182.1625 Removed...................................................63895 182.1751 Removed...................................................63895 182.1911 Removed...................................................63895 182.3616 (c) revised...............................................65939 182.3637 (c) revised...............................................65939 182.3739 (c) revised...............................................65939 182.3766 (c) revised...............................................65939 182.3798 (c) revised...............................................65939 182.3862 (c) revised...............................................65939 182.6033 Removed...................................................63895 182.6195 Removed...................................................63895 182.6386 Removed...................................................63895 182.6511 Removed...................................................63895 182.6625 Removed...................................................63895 182.6751 Removed...................................................63895 182.6851 Removed...................................................63895 182.8195 Removed...................................................63895 184.1033 Added.....................................................63895 184.1139 (c)(2) amended............................................14551 184.1140 Added.....................................................63896 184.1195 Added.....................................................63896 184.1386 Added.....................................................63896 184.1538 (b) and (d) amended.......................................14364 184.1625 Added.....................................................63896 184.1751 Added.....................................................63896 184.1851 Added.....................................................63897 184.1911 Added.....................................................63897 201.20 (a) and (b) amended.........................................60898 Regulation at 59 FR 60898 eff. date corrected to 12-30-94......61929 201.57 (f)(9) revised..............................................64249 201.63 (d) amended.................................................14364 [[Page 290]] 210 Compliance date extended.......................................39255 211 Compliance date extended.......................................39255 310 Technical corrections..........................................49350 310.201 (a)(13) removed; eff. 1-30-95...............................4218 310.545 (a)(6)(ii) redesignated as (a)(6)(ii)(A); new (a)(6)(ii)(A) heading, (B) and (d)(23) added; (d) introductory text and (1) revised; eff. 8-23-95............43409 310.546 Added......................................................43252 314 Authority citation revised.....................................13200 314.50 (h) redesignated as (k); new (h), (i) and (j) added.........50361 (b) corrected..................................................60051 (d)(5)(vi)(a) amended..........................................13200 314.52 Added.......................................................50362 314.53 Added.......................................................50363 314.54 (a)(1)(vii) added...........................................50364 314.70 (f) added...................................................50364 314.94 (a)(12) added...............................................50364 314.95 Added.......................................................50366 314.101 (e) revised................................................50366 314.107 Added......................................................50367 314.108 Added......................................................50368 314.200 (c)(1) amended.............................................14364 314.300 (b)(4) amended.............................................14365 330.1 (i) added.....................................................4000 (g) amended....................................................14365 331.30 (d)(1) removed..............................................60556 336.50 (c)(1) revised; eff. 4-11-95................................16982 338.50 (c)(3) revised; eff. 4-11-95................................16983 341.3 (f), (g) and (h) added; eff. 8-23-95.........................43409 341.12 (h) added; eff. 1-30-95......................................4218 341.14 (a)(5) and (6) added; eff. 6-5-95...........................29174 341.20 Added; eff. 8-23-95.........................................43409 341.72 (c)(4) heading and (6)(iii) heading revised; (d)(8) added; eff. 1-30-95................................................4218 341.74 (c)(4)(vii), (viii), (ix), (d)(1)(iv) and (v) added; eff. 6-5-95.....................................................29174 (d)(1)(iv) and (v) corrected; eff. 6-5-95......................36051 341.80 Added; eff. 8-23-95.........................................43409 341.90 (r) and (s) added; eff. 6-5-95..............................29174 (r) and (s) corrected; eff. 6-5-95.............................36051 (l) added; eff. 1-30-95.........................................4218 343 Announcement...................................................37421 346.18 (b) revised.................................................28767 346.50 (b)(2)(vi) heading and (d)(8) heading amended...............28767 347.10 (c) revised.................................................28768 347.50 (b)(3) heading, (c)(2) heading and (d)(3) heading amended 28768 358 Document availability..........................................62569 358.150 (d)(3) revised; eff. 11-23-95..............................60317 358.703 (e) added; eff. 1-30-95.....................................4001 358.710 (a)(6) redesignated as (a)(7); new (a)(6) added; eff. 1- 30-95.......................................................4001 369.20 Amended; eff. 8-23-95.......................................43412 369.21 Amended; eff. 1-30-95........................................4218 430.4 (a)(69) added................................................40806 430.5 (a)(104) and (b)(106) added..................................40806 430.6 (b)(106) added...............................................40806 (b)(89) revised.................................................8133 436.215 (b) table amended; (c)(18) added...........................40806 (b) table amended...............................................8133 (b) table amended; (c)(17) added................................8856 436.369 Added......................................................40806 436.370 Added......................................................40807 441.20a (a)(1)(i) revised...........................................8133 442.7 Added.........................................................8857 442.52 Added.......................................................26940 442.69 Added; eff. 4-18-94.........................................12546 442.107 Added.......................................................8857 442.107a Added......................................................8857 442.107b Added......................................................8857 442.216a (a)(1), (b)(1)(ii)(a) and (4) revised......................8398 442.253 Redesignated as 442.253a; new 442.253 heading added........26941 442.253a Redesignated from 442.253.................................26941 442.253b Added.....................................................26941 442.270 Added; eff. 4-18-94........................................12546 442.270b Added; eff. 4-18-94.......................................12546 444.320c (a)(1) amended.............................................8398 444.342a (a)(1) amended.............................................8398 444.342c (a)(1) amended.............................................8398 444.342d (a)(1) amended.............................................8399 444.342i (a)(1)(ii) amended.........................................8399 444.342j (a)(1) amended.............................................8399 444.380a (a)(1) amended.............................................8399 444.380c (a)(1) amended.............................................8399 448.330 (a)(1) amended..............................................8399 450.10 Added.......................................................50485 450.24 (a)(1)(i), (ii), (v), (3)(i), (b)(1) and (2) revised; (a)(1)(viii) and (b)(8) added; (b) introductory text amended.....................................................9639 [[Page 291]] 450.224a (a)(1), (3)(i)(a), (b), (b)(1) and (3) revised; (b) introductory text amended; (b)(4) removed...................9641 450.224b (a)(1), (3)(i)(A), (B), (b)(1) and (4) revised; (b) introductory text amended; (b)(2) removed...................9641 452.160 Redesignated as 452.160a; new 452.160 added................52078 452.160a Redesignated from 452.160.................................52078 452.160b Added.....................................................52078 455.86 Added........................................................8400 455.88 Added.......................................................40807 (a)(1) corrected...............................................46479 455.185a (a)(1) amended.............................................8399 455.188 Added......................................................40808 455.285c Added......................................................8400 500.80 (a) amended.................................................14365 509.30 (b) amended.................................................14365 510 Technical correction...........................................49291 510.600 (c)(1) table and (2) table amended....1919, 14367, 28768, 31139, 33197, 33198, 33908, 38119, 41664, 41976, 44315, 49576, 50829, 59364 520 Technical correction...........................................50829 520.45a (a), (b), (c), (d)(1), (2) and (3) redesignated as (a)(1), (2), and (3), (a)(4)(i), (ii) and (iii); new (b) added.....65711 520.445b (a) amended; (b), (d)(1), (2), (4)(iii)(B), (C), (iv)(B) and (C) revised; (d)(3) removed; (d)(4)(i)(C) added........39439 520.531 (a) removed; (b) revised...................................26942 520.580 (b)(1) amended.............................................59365 520.804 Added......................................................17694 520.903c Removed...................................................33198 520.905a (d)(3) added..............................................26943 520.905b (c)(3) added..............................................35252 520.1660d (a)(4), (b)(2) and (e)(1)(iii)(C) revised.................3318 (a)(6) and (b)(4) added; (e)(1)(ii)(A)(3), (B)(3), (C)(3) and (iii)(C) amended...................................................41664 (e)(1)(ii)(A)(3), (B)(3) and (C)(3) corrected..................56388 520.1696b (b) revised; (c)(2) amended..............................42493 (b) revised....................................................58775 520.1720a (b)(3) amended...........................................53585 520.1806 (b) amended...............................................28769 520.1872 Added.....................................................33908 520.1962 (b) removed................................................5705 520.2045 (b)(2) amended............................................28769 520.2155 Removed....................................................1919 520.2220a (b) amended..............................................56000 520.2220b (b)(1) amended...........................................56000 520.2220c (c) amended..............................................56000 520.2220d (b) amended..............................................56000 520.2260a (b)(1) amended...........................................22754 520.2260b (b)(1) amended...........................................22754 520.2260c (a) amended..............................................22754 520.2325a (c)(2) amended...........................................28769 (c) amended....................................................33197 520.2325b (c) amended..............................................33197 520.2345a (b)(1) amended...........................................59365 520.2345d Revised..................................................17693 (a)(1) amended.................................................19133 520.2520h Removed...................................................1919 520.2640 (a) amended...............................................14365 522.246 (a) amended; (c)(3) added..................................41665 522.313 (d)(4) added...............................................41666 (d)(5) added...................................................54518 522.900 (b)(2) amended.............................................14367 522.1145 (a)(2) amended............................................33198 522.1222a (c) revised.......................................41664, 41976 Corrected......................................................49291 522.1350 Added.....................................................37422 522.1680 (b) amended...............................................31139 522.1696a (b)(1) and (2) amended...................................38119 522.1720 (b)(1) amended............................................53585 522.1940 (e) redesignated as (d)(2)(iv); (b), (d)(2)(ii), (iii) and (iv) revised; interim..................................49808 522.2220 (a)(2)(i) amended.........................................56000 522.2640a (a) amended..............................................14365 522.2640b (a) amended..............................................14365 522.2662 (b) amended...............................................14367 522.2680 Revised...................................................19639 524.900 (c) amended................................................28769 524.1484h Added.....................................................5105 524.1580d (b) amended...............................................5705 524.1580b (b) amended..............................................33197 524.1580c (b) amended..............................................33197 524.1580d Removed..................................................53586 524.2640 (a) amended...............................................14365 529.1030 (b) revised; (d) redesignated as (c)(3)...................60076 529.1044a (b) amended..............................................31140 529.1186 (b) amended...............................................44315 556.34 Revised.....................................................65711 556.200 Revised....................................................41977 556.275 Revised....................................................26943 556.344 (a) revised; (d) added.....................................50830 556.380 Revised....................................................41241 556.425 Revised....................................................17922 556.750 (c) added..................................................38902 558.4 (d) table amended..............................17477, 18297, 41241 [[Page 292]] 558.95 (b)(1)(xi)(b) amended.......................................14368 (b)(4)(ii) added...............................................15624 (b)(1)(xii)(b) amended.........................................19134 (b)(1)(x)(b) and (xi)(b) amended...............................33197 558.128 (c)(5)(xiii) removed........................................8134 558.258 (c)(4) added...............................................35252 558.265 (c)(3) added...............................................51498 558.274 (a)(4) and (c)(1) table amended............................59365 558.305 Added......................................................18297 558.311 (e)(1) table amended.......................................33197 558.340 (c)(2) removed..............................................8134 558.342 (c)(1)(ii), (2)(ii), (3)(ii), (4)(ii), (5)(ii) and (6)(ii) amended....................................................41241 558.355 (f)(1)(xii)(b) and (xx)(b) amended.........................33197 (f)(3)(iv)(b) and (viii) amended...............................41241 (f)(2)(ii) and (iii) redesignated as (f)(2)(i)(a) and (f)(2)(i)(b); new (f)(2)(i)(b) revised; new (f)(2)(ii) added.......62320 558.360 (d)(2) redesignated as (d)(2)(i); new (d)(2)(i) heading and (ii) added; (d)(3) amended.............................17922 558.550 (a) revised................................................12547 (a) revised; (b)(1)(ii)(c), (iv)(c), (v)(c), (ix)(c), (xii)(c), (xiv)(c) and (xv)(c) amended.............................14368 (a)(2) amended.................................................15339 (a)(2) revised.................................................15339 (a)(2) amended............................19134, 21930, 26423, 26943 (a)(2), (b)(1)(x)(c), (xii)(b) and (c) amended.................26424 (b)(1)(ii)(c) amended..........................................33197 (b)(2) added...................................................49577 (a)(2) corrected...............................................64739 (a) revised....................................................67185 558.555 Added......................................................17477 558.586 (a) amended................................................33197 558.600 (c)(1)(i) amended; (c)(3) added............................41975 558.625 (a) amended................................................14365 (b)(71) removed................................................33198 558.635 (f)(3) redesignated as (f)(4); new (f)(3) added............38902 (b)(2) amended.................................................54518 573.130 Added......................................................26711 573.920 Stay at 58 FR 47973 confirmed..............................45973 600 Authority citation revised.....................................54042 600.15 (b) amended.................................................49351 600.80--600.90 (Subpart D) Added...................................54042 606.65 (c) table amended...........................................23636 606.121 (c)(12)(i), (ii) and (iii) amended.........................23636 610.9 (a) amended..................................................49351 610.11 Introductory text amended...................................49351 610.53 (d) amended.................................................49351 630.10 (c)(3) amended..............................................49351 640.6 Introductory text amended....................................49351 640.21 (c) amended.................................................49351 640.22 (c) amended.................................................49351 640.64 (c) amended.................................................49351 640.74 (a) amended.................................................49351 660.28 (a)(1) table and (4) amended................................23637 807.3 (n) amended; (o) and (q) revised.............................64295 807.87 (i)(2) and (j) amended......................................64295 807.92 (a) introductory text, (3) through (6) and (b) amended; (d) added......................................................64295 807.93 Revised.....................................................64295 807.94 Revised.....................................................64296 807.95 (d) revised.................................................64296 808.20 (b) amended.................................................14365 812 Notice of applicability........................................52078 821.2 (b) introductory text amended................................31138 821.20 (c) table corrected.........................................15052 864.5350 (b) revised...............................................63007 864.7660 (b) revised...............................................63007 864.7675 (b) revised...............................................63007 864.7900 (b) revised...............................................63007 864.8500 (b) revised...............................................63007 866.5170 (b) revised...............................................63007 866.5220 (b) revised...............................................63007 866.5230 (b) revised...............................................63007 866.5360 (b) revised...............................................63007 866.5370 (b) revised...............................................63007 866.5540 (b) revised...............................................63007 866.5700 (b) revised...............................................63007 868.5340 (b) revised...............................................63007 868.5350 (b) revised...............................................63007 870.1875 (a)(2) revised............................................63007 872.1500 (b) revised...............................................63007 872.1820 (b) revised...............................................63008 872.3100 (b) amended...............................................63008 872.3130 (b) revised...............................................63008 872.3165 (b) revised...............................................63008 872.3240 (b) revised...............................................63008 872.3285 (b) revised...............................................63008 872.3330 (b) revised...............................................63008 872.3350 (b) revised...............................................63008 [[Page 293]] 872.3360 (b) revised...............................................63008 872.3410 (b) revised...............................................63008 872.3450 (b) revised...............................................63008 872.3490 (b) revised...............................................63008 872.3520 (b) revised...............................................63008 872.3530 (b) revised...............................................63008 872.3580 (b) revised...............................................63008 872.3670 (b) revised...............................................63008 872.3900 (b) revised...............................................63008 872.3910 (b) revised...............................................63008 872.3940 Added.....................................................65478 872.3950 Added.....................................................65478 872.3960 Added.....................................................65478 872.3970 Added.....................................................65478 872.4130 (b) revised...............................................63008 872.4535 (b) revised...............................................63008 872.4620 (b) revised...............................................63008 872.4730 (b) revised...............................................63008 872.5410 (b) revised...............................................63009 872.5525 (b) revised...............................................63009 872.5550 (b)(1) revised............................................63009 872.6030 (b) revised...............................................63009 872.6140 (b) revised...............................................63009 872.6250 (b) revised...............................................63009 872.6300 (b) revised...............................................63009 872.6475 (b) revised...............................................63009 872.6510 (b) revised...............................................63009 872.6640 (b) revised...............................................63009 872.6865 (b) revised...............................................63009 872.6890 (b) revised...............................................63009 874.3375 (b) revised...............................................63009 874.4750 (b) revised...............................................63009 874.5220 (b) revised...............................................63009 874.5800 (b) revised...............................................63009 876.5970 (b) revised...............................................63010 878.1800 (b) revised...............................................63010 878.3750 (b) revised...............................................63010 878.3800 (b) revised...............................................63010 878.3900 (b) revised...............................................63010 878.4100 (b) revised...............................................63010 878.4380 (b) revised...............................................63010 878.4440 (b) revised...............................................63010 878.4470 (b) revised...............................................63010 878.4635 (b) revised...............................................63010 878.4660 (b) revised...............................................63010 878.4700 (b) revised...............................................63010 878.4730 (b) revised...............................................63010 878.4800 (b) revised...............................................63010 878.4930 (b) revised...............................................63010 878.4950 (b) revised...............................................63010 878.5900 (b) revised...............................................63010 880.2400 (b) revised...............................................63010 880.2720 (b)(1) revised............................................63011 880.5180 (b) revised...............................................63011 880.5210 (b) revised...............................................63011 880.5240 (b) revised...............................................63011 880.5630 (b) revised...............................................63011 880.5740 (b) revised...............................................63011 880.5780 (b)(2) revised............................................63011 880.5950 (b) revised...............................................63011 880.6060 (b) revised...............................................63011 880.6150 (b) revised...............................................63011 880.6190 (b) revised...............................................63011 880.6900 (b) revised...............................................63011 882.1430 (b) revised...............................................63011 882.1700 (b) revised...............................................63011 882.1925 (b) revised...............................................63011 882.4030 (b) revised...............................................63011 882.4125 (b) revised...............................................63012 882.4190 (b) revised...............................................63012 882.4200 (b) revised...............................................63012 882.4215 (b) revised...............................................63012 882.4440 (b) revised...............................................63012 882.4500 (b) revised...............................................63012 882.4525 (b) revised...............................................63012 882.4535 (b) revised...............................................63012 882.4600 (b) revised...............................................63012 882.4900 (b) revised...............................................63012 884.5320 Added.....................................................67187 886.1040 (b) revised...............................................63012 886.1050 (b) revised...............................................63012 886.1070 (b) revised...............................................63012 886.1090 (b) revised...............................................63012 886.1140 (b) revised...............................................63012 886.1160 (b) revised...............................................63012 886.1250 (b) revised...............................................63012 886.1290 (b) revised...............................................63012 886.1340 (b) revised...............................................63012 886.1350 (b) revised...............................................63012 886.1425 (b) revised...............................................63013 886.1430 (b) revised...............................................63013 886.1435 (b) revised...............................................63013 886.1450 (b) revised...............................................63013 886.1660 (b) revised...............................................63013 886.1680 (b) revised...............................................63013 886.1690 (b) revised...............................................63013 886.1700 (b) revised...............................................63013 886.1810 (b) revised...............................................63013 886.1860 (b) revised...............................................63013 886.1870 (b) revised...............................................63013 886.1910 (b) revised...............................................63013 886.1945 (b) revised...............................................63013 886.4250 (b) revised...............................................63013 886.4350 (b) revised...............................................63013 886.4360 (b) revised...............................................63013 886.4570 (b) revised...............................................63013 886.4750 (b) revised...............................................63014 886.4855 (b) revised...............................................63014 886.5820 (b) revised...............................................63014 886.5840 (b) revised...............................................63014 886.5842 (b) revised...............................................63014 886.5844 (b) revised...............................................63014 [[Page 294]] 886.5900 (b) revised...............................................63014 886.5915 (b) revised...............................................63014 886.5916 (b) and (c) revised; eff. 4-4-94..........................10284 886.5925 (b) and (c) revised; eff. 4-4-94..........................10284 888.4200 (b) revised...............................................63014 888.4210 (b) revised...............................................63014 888.4230 (b) revised...............................................63014 888.4540 (b) revised...............................................63014 888.5940 (b) revised...............................................63014 890.1175 (b) revised...............................................63014 890.3100 (b) revised...............................................63014 890.3750 (b) revised...............................................63014 890.3920 (b) revised...............................................63014 890.3940 (b) revised...............................................63015 890.5765 (b) revised...............................................63015 892.1130 (b) revised...............................................63015 892.1350 (b) revised...............................................63015 892.1640 (b) revised...............................................63015 892.5740 (b) revised...............................................63015 900 Workshop.......................................................53586 Technical correction...........................................60051 900.2 (f) corrected.................................................6899 (e) revised; (r) and (s) added; interim........................49812 900.12 (d)(1) corrected.............................................6899 (d)(1)(i) revised; interim.....................................49812 900.18 Added; interim..............................................49812 1010.4 (b) introductory text amended...............................14365 1010.5 (c) introductory text amended...............................14365 1020.30 (b) amended................................................26403 1020.32 (d) revised; (e) through (h) redesignated as (f) through (i); new (e) added.........................................26404 1030.10 (c)(6)(iv) amended.........................................14365 1220.40 (a) revised................................................35253 1240.62 (e) amended................................................14366 1250.51 (f)(4)(ii) amended.........................................14366 1270 Workshop......................................................29950 Chapter II 1301.13 (a) and (b) revised.........................................8859 1306.02 (h) redesignated as (i); new (h) added.....................26111 1306.11 (a) revised; (e) and (f) added.............................26111 (a) and (f) corrected..........................................30832 1306.21 (a) and (c) revised........................................26112 1306.31 (c) revised................................................26112 (c) corrected..................................................30832 1308.11 (g)(5) added.................................................673 Regulation at 58 FR 13534 eff. date extended to 9 12 94........10720 (f)(1) through (6) redesignated as (f)(2) through (7); new (f)(1) added.......................................................12829 (g)(3) removed; (g)(4) and (5) redesignated as (g)(3) and (4) 12830 (g)(3) removed; (d)(1) through (29) and (g)(4) redesignated as (d)(2) through (30) and (g)(3); new (d)(1) added...................46759 Regulation at 59 FR 673 eff. date extended.....................65710 1308.24 (i) table revised..........................................15053 Regulation at 59 FR 15053 confirmed............................52905 1310 Technical correction..........................................52588 1310.04 (f) introductory text revised; (f)(1)(iii) removed; (f)(1)(iv) through (xxiv) redesignated as (f)(1)(iii) through (xxiii); (g) added.................................51367 1310.06 (b) revised; interim.......................................51364 1310.09 Added; interim.............................................13882 1313 Technical correction..........................................52588 1313.12 (a) introductory text revised..............................51367 1313.21 (a) introductory text revised..............................51367 1995 21 CFR 60 FR Page Chapter I 5.10 (a)(37) added.................................................24767 5.22 (a)(1) through (13), (b)(1) and (2) revised; (a)(14) and (b)(3) added...............................................26826 5.36 Revised.......................................................15871 5.37 (a) introductory text, (4)(iii), (b) introductory text and (5) introductory text revised; (a)(6)(v) through (viii) added......................................................15871 5.51 (b)(1) revised.................................................2014 5.61 (h) added.....................................................36594 5.63 Introductory text revised.....................................15871 5.80 (a)(1)(iii) revised; (a)(1)(iv) removed.......................57338 5.81 Added.........................................................54424 5.85 Revised.......................................................47268 5.98 Added.........................................................63607 5.99 Removed.......................................................38626 5.100 Revised......................................................16568 5.115 Revised......................................................16570 10.50 (c)(21) removed..............................................38626 14.100 (c)(2)(ii), (6) heading and (ii) revised.....................9297 [[Page 295]] 16 Workshop........................................................27406 17 Added...........................................................38626 19.21 (a), (b) and (c) amended.....................................47478 20 Authority citation revised......................................63381 20.63 (f) added....................................................16968 20.86 Amended......................................................38633 20.88 (d) and (e) added............................................63381 20.89 (d) added....................................................63382 25.22 (a)(10) revised..............................................36594 25.31a (a) introductory text, (b)(1) introductory text and (2) introductory text revised..................................36594 73.35 Added........................................................18738 (b) and (d)(3) stayed..........................................41805 (b) and (d)(3) stay at 60 FR 41805 rescinded; eff. 11-1-95.....55446 73.250 (a)(1) amended..............................................52629 73.260 (a)(1) amended..............................................52629 73.3106 (a) revised................................................10497 Regulation at 60 FR 10497 confirmed as 3-30-95.................32264 74.1705 Regulations at 59 FR 60897 and 61929 eff. date confirmed as 12-30-94.................................................5131 74.2705 Regulations at 59 FR 60898 and 61929 eff. date confirmed as 12-30-94.................................................5131 101 Notice..........................................................7711 Authority citation revised.....................................67174 101.2 (d)(1) revised...............................................17205 101.3 (e)(4)(ii) revised; eff. 1-1-97..............................67174 101.9 (i) revised; (j)(17) revised.................................17205 (j)(17) corrected..............................................30788 (c)(8)(iv) revised; eff. 1-1-97................................67174 101.13 (j)(2)(iv)(B) revised.......................................17205 101.36 (b)(3) introductory text, (i), (ii), (4) introductory text and (vi) revised; eff. 1-1-97..............................67175 101.54 (e)(1)(iii)(B) and (2)(iii)(B) revised......................17206 101.56 (b)(3)(ii), (c)(1)(ii)(B), (2)(ii)(B) and (g) amended.......17206 101.60 (b)(4)(ii)(B), (5)(ii)(B), (c)(4)(ii)(B) and (5)(ii)(B) revised....................................................17206 101.61 (b)(6)(ii)(B), (7)(ii)(B) and (c)(2)(iii) revised...........17206 101.62 (b)(4)(ii)(B), (5)(ii)(B), (c)(4)(ii)(B), (5)(ii)(B), (d)(1)(ii)(F)(2), (2)(iii)(E)(2), (iv)(E)(2), (4)(i)(C)(2), (ii)(D)(2), (5)(i)(C)(2) and (ii)(D)(2) revised....................................................17207 102.50 Table revised...............................................34460 103.35 Removed; eff. 5-13-96.......................................57123 123 Added; eff. 12-18-97...........................................65197 129.35 (a)(3)(ii) and (iii) revised; (a)(4) added; eff. 5-13-96....57123 129.80 (g) introductory text revised; eff. 5-13-96.................57124 146.113 Removed....................................................56514 165 Added; eff. 5-13-96............................................57124 165.110 (a)(2)(v) and (b)(4)(i)(C)(4) corrected; eff. 5-13-96......66495 170.3 (e) redesignated as (e)(1); (e)(2) added.....................36594 170.39 Added.......................................................36595 171.8 Added........................................................36596 172.120 (b)(1) table amended.......................................33710 172.723 Added......................................................32903 172.800 (c)(12) added..............................................21702 172.841 (a)(1) revised.............................................54425 172.859 (c)(1) and (2) revised.....................................44756 173.69 Added.......................................................11900 173.340 (a)(3) table amended.......................................54036 174.6 Added........................................................36596 175.105 (c)(5) table amended................................47480, 49337 175.250 (a), (b)(1) and (2) amended................................39645 175.300 (b)(3)(viii)(b) and (xxxiii) amended.......................48646 (b)(3)(xi) amended.............................................49337 (b)(3)(xxxiii) amended.........................................57339 176.170 (b)(2) table amended.......................................18350 (a)(5) table amended......................34135, 39646, 44757, 62207 Regulation at 60 FR 34135 eff. date corrected to 7-31-95.......47205 176.180 (b)(2) table amended.......................................18350 177.1315 (b) table amended.........................................57926 177.1520 (a)(3)(i)(a) redesignated as (a)(3)(i)(a)(1); (a)(3)(i)(a)(2) added; (c) table amended...................40074 (a)(6) added; (c) table amended................................54189 177.1630 (a), (b) and (j) introductory text revised; (e)(4)(ii) amended....................................................57927 (e)(4) amended.................................................61654 177.2440 (a) and (b) revised.......................................48648 177.2600 (c)(4)(ii)(a) and (b) amended.............................39648 177.2910 Introductory text revised; (e) and (f) redesignated as (f) and (g); (a)(4) and new (e) added......................54426 178.1010 (b)(44) and (c)(38) added.................................18740 178.2010 (b) table amended......8546, 18353, 22269, 33711, 43371, 49338, 49507, 54428 [[Page 296]] 178.3130 (b) table amended..................................18351, 54430 178.3297 (e) table amended..................................31244, 39649 178.3400 (c) table amended.........................................18351 178.3570 (a)(3) table amended......................................44758 179.26 (b) table amended...........................................12670 182.70 Amended.....................................................62208 184.1012 Added.....................................................55789 184.1024 Added.....................................................32910 184.1034 Added.....................................................32910 184.1101 (a) and (e) revised; eff. 4-27-95.........................15872 184.1316 Added.....................................................32910 184.1329 Added.....................................................63621 184.1415 Added.....................................................32911 184.1443a Added....................................................32911 184.1444 (a) amended; (b) revised..................................48893 184.1563 (c) revised; eff. 5-13-96.................................57130 184.1583 Added.....................................................32911 184.1595 Added.....................................................32911 184.1914 Added.....................................................32911 184.1985 Added.....................................................54193 186.1555 Added.....................................................62208 189.240 Added......................................................33109 201.20 Regulations at 59 FR 60898 and 61929 eff. date confirmed as 12-30-94....................................................5131 202.1 (e)(4)(i)(b)(3) amended......................................38480 206.10 (a) amended.................................................19846 210 Compliance date extension......................................20897 211 Compliance date extension......................................20897 211.42 (c) introductory text amended................................4091 211.68 (b) amended..................................................4091 211.137 (g) redesignated as (h); new (g) added......................4091 211.170 (b) introductory text amended...............................4091 211.180 (e)(1) revised..............................................4091 310 Technical correction....................................17611, 57927 310.201 (a)(10) and (15) removed; eff. 10-7-96.....................52507 310.543 Added......................................................20165 310.545 (a)(7) corrected; CFR correction............................5313 (a)(15) and (d)(1) revised; (d)(18) added; eff. 8-15-95.........8920 (a)(9) removed; (d)(1) revised.................................20165 (d)(1) corrected...............................................20898 (a)(6)(iv), (d)(19) and (20) added.............................38642 (a)(15)(ii) stayed in part.....................................42436 (a)(2) redesignated as (a)(2)(i); (a)(2)(i) heading, (ii) and (d)(24) added; (d) introductory text and (1) revised; eff. 10-7-96 52507 328 Added; eff. 3-13-96............................................13595 355 Added; eff. 10-7-96............................................52507 Technical correction...........................................57927 355.50 (a) corrected...............................................57927 369 Technical correction...........................................57927 369.21 Amended; eff. 10-7-96.......................................52510 429.55 (b) revised; interim........................................56516 430.4 (a)(70) added................................................58230 430.5 (a)(105) and (b)(107) added..................................58230 430.6 (b)(107) added...............................................58230 436.105 Table corrected; CFR correction............................66898 436.106 Table corrected; CFR correction............................66898 436.215 (b) table amended; (c)(9) revised..........................27221 (b) table amended; (c)(19) added...............................58230 442.52 (b)(1)(iv) and (3) revised..................................33712 442.54 Added.......................................................58231 442.119 Redesignated as 442.119a; new 442.119 added................27222 442.119a Redesignated from 442.119.................................27222 442.119b Added.....................................................27222 442.154 Added......................................................58232 442.154a Added.....................................................58232 442.154b Added.....................................................58233 450.10 Stayed......................................................11027 Removed........................................................16377 453.522d Added.....................................................49508 500.26 (a) amended.................................................38480 500.27 (a)(3) amended..............................................38480 501.4 (b)(13) amended..............................................38480 510.413 (b) amended................................................38480 510.600 (c)(1) table and (2) table amended.....7121, 11027, 14216, 16571 (c)(1) table and (2) table amended.......29755, 32447, 33110, 33342, 34135, 35122, 35838, 39846, 40454, 40455, 47052, 47480, 54193, 55658, 63622 520.45a (b) amended................................................55658 520.45b (b) amended................................................55658 520.88a (b) amended................................................55658 520.88b (b) amended................................................55658 520.88c (b) amended................................................55658 520.88d (b) amended................................................55658 520.88e (b) amended................................................55659 520.88g (b) amended................................................55659 520.88h (b) amended................................................55659 520.90b (b) amended................................................55659 520.90f (b) amended................................................55659 520.445b (d)(4) introductory text amended..........................26827 (b) and (d)(4)(iii)(C) amended.................................47052 520.540c (b) amended...............................................55659 [[Page 297]] 520.550 (b) amended................................................55659 520.622c (b)(2) amended............................................55659 (b)(3) amended.................................................57832 520.623 (b) amended................................................55659 520.704 Removed....................................................63622 520.816 (b) amended................................................55659 520.1263c (a) revised..............................................14217 520.1284 (b) amended...............................................55659 520.1288 Added.......................................................362 520.1289 Added.....................................................20402 520.1445 (c)(2) and (3) amended....................................50097 520.1484 (b) revised...............................................14217 520.1485 Heading and (b) revised....................................3079 520.1560 Removed...................................................39847 520.1560a Removed..................................................39847 520.1560b Removed..................................................39847 520.1638 (b) amended...............................................55659 520.1640 (b) amended...............................................55659 520.1660d (b)(2) amended; (c) removed..............................40455 520.1696b (b) revised..............................................26359 520.1801 Removed...................................................39847 520.1801a Removed..................................................39847 520.1840 (c)(1) and (2) amended....................................55659 520.1880 (b) amended...............................................57832 520.1920 (b) amended...............................................55659 520.1921 (b) amended...............................................55659 520.2095 Added.....................................................50097 520.2260a (b)(1) amended...........................................55659 520.2260b (b)(1) amended...........................................55659 520.2260c (a) amended..............................................55659 520.2604 (b) amended...............................................55659 520.2605 (b) amended...............................................55659 522.88 (b) amended.................................................55659 522.90a (b)(1) amended.............................................55659 522.90c (b) amended................................................55659 522.313 (d)(1)(ii) amended.........................................51719 522.514 Removed....................................................63622 522.540 (a)(2) revised.............................................29985 (d)(2)(i) amended..............................................55659 (d)(2)(ii) removed; (d)(2)(iii) redesignated as (d)(2)(ii).....63622 522.723 (c) amended................................................39847 522.883 (c) amended................................................39847 522.970 (b) revised.........................................48650, 54942 522.1044 (a) and (b)(1) revised; (b)(4) added......................29985 522.1060 Removed...................................................27223 522.1060a Removed..................................................27223 522.1060b Removed..................................................27223 522.1085 (b) amended...............................................27223 522.1086 Added.....................................................27223 522.1192 Heading and (a)(3) heading revised; (d)(5) added..........45041 522.1222a (a) and (d) removed; (c) revised.........................49339 522.1290 (b) amended...............................................55659 522.1362 Added.....................................................49340 522.1563 Removed...................................................39847 522.1660 (b) and (c)(2)(iii) amended..........................363, 14218 (b) and (c)(2)(iii) amended....................................29755 522.1662a (h)(2) revised...........................................48651 522.1720 (c) and (d) amended; (b)(2) revised.......................53509 (b)(1) amended.................................................63622 522.1880 Removed...................................................63622 522.1920 (b) amended...............................................55659 522.2095 Added.....................................................57833 522.2100 (d)(2) revised............................................57833 522.2477 Revised....................................................4376 522.2662 (b) amended.................................33110, 35122, 35123 522.2670 (b) amended...............................................57832 522.2680 (d)(3) added..............................................26360 524.575 Added......................................................48651 524.1005 (b)(1) amended............................................55659 524.1465 (b) amended...............................................55659 524.1580a Removed..................................................39847 524.1580b (b) amended..............................................55659 524.1580c (b) amended..............................................55659 524.1600a (b) amended..............................................55660 526.88 (b) amended.................................................55660 526.464a (d) amended...............................................55660 526.464b (d) amended...............................................55660 526.464c (b) amended...............................................55660 526.464d (b) amended...............................................55660 529.1044a (b) amended.......................................45042, 48894 529.1186 (b) revised...............................................40456 529.2464 (b) amended...............................................55660 556.594 Added......................................................50098 558.4 (d) table amended..............................39848, 57928, 66495 558.62 (c)(2)(v) removed; (c)(2)(vi) redesignated as (c)(2)(v).....39847 558.76 (d)(3)(v) added.............................................29483 558.95 (b)(1)(xi)(b) and (xii)(b) amended..........................11027 (b)(1)(x)(b) and (xi)(b) amended...............................18741 (a)(4) amended.................................................47052 558.105 Removed....................................................39847 558.128 (c)(5)(iii) removed........................................39847 558.195 (c)(2) removed; (d) table amended..........................34461 (d) table amended..............................................53702 558.274 (a)(7), (c)(1)(i) table and (ii) table amended.............47052 558.300 (c)(1)(i) and (iii) revised................................39848 558.305 (a) amended................................................53509 558.311 (e)(1) table amended.......................................18741 (b)(6) and (e)(1) table amended; (b)(7) added..................29481 [[Page 298]] (b)(7) revised; (e)(1) table amended....................29482, 57929 (b)(3) and (e)(1) table amended................................54194 558.325 (c)(3)(iv) removed.........................................39847 558.342 (c)(4)(ii)(C) amended......................................11028 558.355 (f)(1)(xii)(b) and (xx)(b) amended.........................18741 (f)(3)(x) added................................................63623 558.366 (c) table amended..........................................29483 (a) amended....................................................33343 558.450 (d)(1) Table 1 amended......................................3080 558.460 (c)(2)(v) removed..........................................39847 558.464 (a)(1) and (2) amended.....................................55660 558.465 (a) amended................................................55660 558.485 (a)(11) amended............................................47052 558.530 (d)(3)(vii) removed........................................39847 558.550 (a)(2) revised; (b)(1)(ii)(a) and (xv)(a) amended...........3080 (a)(1) amended; (a)(2) revised.................................11027 (b)(1)(ii)(c) amended..........................................18741 558.555 (b)(1)(iii) amended........................................57928 558.625 (b)(10) revised.............................................7121 (b)(11) and (15) removed........................................8547 (b)(52) amended................................................47053 (b)(83) amended................................................66496 558.630 (b)(3), (8) and (10) amended...............................47053 (b)(10) amended................................................66496 558.635 (b)(2) revised..............................................8547 (b)(1) amended.................................................55660 573.920 Introductory text and (a) through (f) redesignated as (a) through (g); new (a) revised; interim......................53703 579.40 Added.......................................................50099 803 Revised; eff. 4-11-96..........................................63597 807.3 (r) added; eff. 4-11-96......................................63606 807.20 (a)(6) added; eff. 4-11-96..................................63606 807.22 (a) revised; eff. 4-11-96...................................63606 807.40 Revised; eff. 4-11-96.......................................63606 862.2310 (b) revised...............................................38899 862.2320 (b) revised...............................................38900 862.2485 (b) revised...............................................38900 862.2720 (b) revised...............................................38900 862.2800 (b) revised...............................................38900 862.2920 (b) revised...............................................38900 866 Compliance date extension......................................54942 866.2560 (b) revised...............................................38482 872.3740 (b) revised...............................................38900 872.3810 (b) revised...............................................38900 872.6100 (b) revised...............................................38900 876 Authority citation revised.....................................17216 876.3750 (c) revised...............................................17216 882.5800 (c) revised...............................................43969 886.4350 (b) corrected.............................................15872 892.1990 Added.....................................................36639 900 Technical correction............................................3451 1000 Authority citation revised....................................48380 1000.3 Revised.....................................................48380 1002 Authority citation revised....................................48382 1002.1 Revised.....................................................48382 1002.2 Removed.....................................................48385 1002.3 Revised.....................................................48385 1002.7 Introductory text and (b) amended; (c) added................48385 1002.10--1002.13 (Subpart B) Revised...............................48386 1002.20 (c) amended................................................48386 1002.30 (a) introductory text amended; (a)(5) added................48386 1002.31 (c) amended................................................48386 1002.40 (a) revised................................................48386 1002.50 Revised....................................................48387 1002.61 (Subpart G) Removed........................................48387 1220.40 (a) revised................................................29987 1240.3 (r) revised; (s), (t) and (u) added; eff. 12-18-97..........65201 1240.60 Heading revised; existing text designated as (a) and amended; (b), (c) and (d) added; eff. 12-18-97.............65202 1270 Workshop......................................................27406 Chapter II 1301 Policy statement..............................................55310 1301.24 (b), (c) introductory text and (5) revised.................36641 1308.24 (i) table amendeded........................................15956 1301.37 (a) revised................................................32101 1301.43 (a) revised................................................32101 1301.44 (b) redesignated as (c); new (b) added.....................32101 1301.54 (a) through (d) revised....................................32101 1301.55 (a) revised................................................32102 1306.05 (b) revised................................................36641 1307.03 Revised....................................................32454 1308.11 (d)(3) through (30) redesignated as (d)(4) through (31); new (d)(3) added; (g)(3) removed...........................28719 1309 Added.........................................................32454 1309.02 (f), (g) and (h) correctly redesignated as (e), (f) and (g)........................................................42436 1309.12 (b) corrected..............................................35264 1310 Technical correction..........................................54409 1310.01 (b) through (e), (f)(1) and (g) revised; (k) redesignated as (m); new (k) and (l) added..............................32459 1310.02 (b)(10) added..............................................19510 Introductory text, (a) and (b) revised.........................32460 [[Page 299]] 1310.04 (f)(2)(v) added............................................19510 (a), (b), (f)(1) and (2) introductory text revised; (f)(1)(xiv), (xx) and (xxii) removed; (f)(1)(xv) through (xix), (xxi), and (xxiii) redesignated as (f)(1)(xiv) through (xviii), (xix) and (xx); new (f)(1)(xxi) and (xxii) added...................32460 1310.04 (f)(1)(xxii) and (xxiii) correctly redesignated as (f)(1)(xxi) and (xxii).............................................42436 1310.06 Regulation at 59 FR 51364 confirmed........................17628 (a) introductory text, (1), (c) and (d) revised................32461 1310.07 (a) and (b) revised........................................32461 1310.08 (c), (d) and (e) added.....................................19510 (b) introductory text revised..................................32461 1310.09 Revised; interim...........................................53122 1310.10 Added......................................................32461 1310.11 Added......................................................32462 1310.14 Added......................................................32462 1310.15 Added......................................................32463 1313.01 Amended....................................................32465 1313.02 (c), (d) introductory text, (1), (h) and (i) revised; (m) redesignated as (o); new (m) and (n) added.................32463 1313.12--1313.15 Undesignated center heading amended...............32465 1313.12 (c) revised; (d), (e) and (f) added........................32464 1313.13 (a) amended................................................32465 1313.14 Introductory text and (a) amended..........................32465 1313.15 Revised....................................................32464 1313.21--1313.25 Undesignated center heading amended...............32465 1313.21 (d) redesignated as (g); (c) and new (g) revised; new (d), (e) and (f) added..........................................32464 1313.22 (a) amended................................................32465 1313.23 Introductory text and (a) amended..........................32465 1313.31 Undesignated center heading added..........................32465 1313.32 Added......................................................32465 1313.33 Added......................................................32465 1313.34 Added......................................................32465 (a) corrected..................................................35264 1316 Authority citation revised....................................32465 1316.02 (c)(2) revised.............................................32465 (c)(2) corrected...............................................35264 1316.03 (b) through (e) revised....................................32465 1316.09 (a)(3) revised.............................................32466 Chapter III 1403.36 (d), (g), (h) and (i) revised.......................19639, 19642 1404.100 Revised............................................33040, 33045 1404.105 Amended............................................33041, 33045 1404.110 (c) revised........................................33041, 33045 1404.200 Revised............................................33041, 33045 1404.215 Revised............................................33041, 33045 1404.220 Revised............................................33041, 33045 1404.225 Revised............................................33041, 33045 1404 Appendixes A and B revised.............................33042, 33045 1996 21 CFR 61 FR Page Chapter I Chapter I Compliance date announcement......................67710, 68145 1.24 (a)(6)(i), (ii) and (iii) amended.............................14478 2.125 (e)(14) added................................................15700 (e)(15) added..................................................25392 5.20 (f)(1) revised.................................................2414 5.22 (a)(9)(xiii) correctly added...................................9639 5.31 (f)(1)(vi), (2)(x) and (8) added...............................8215 (f)(1)(vi), (2)(x) and (8) corrected...........................11545 5.98 Added..........................................................8215 Second 5.98 correctly designated as 5.99.......................11545 5.99 Correctly designated..........................................11545 Corrected......................................................14375 5.100 Footnotes 9 and 12 amended; Footnote 17 added.................8472 Revised........................................................24224 5.115 Revised......................................................24226 14.100 (c)(9) heading, (ii), (16) heading and (ii) revised.........28048 (b)(6) added...................................................36624 20.100 (c)(41) added...............................................33244 25.22 (a) amended..................................................14245 25.24 (b)(2) amended...............................................14245 25.30 (a) amended..................................................14245 50.3 (n) added.....................................................51528 50.24 Added........................................................51528 50.27 (a) revised..................................................57280 56.109 (c) revised; (d) and (e) redesignated as (e) and (f); new (e) amended; new (d) and (g) added.........................51529 70.3 (e) amended...................................................14478 70.19 (p) amended..................................................14478 [[Page 300]] 71.1 (c) amended...................................................14478 73 Regulation at 61 FR 40319 eff. date confirmed...................64027 73.165 Added.......................................................40319 73.250 Regulation at 60 FR 52629 eff. date confirmed................7990 73.260 Regulation at 60 FR 52629 eff. date confirmed................7990 73.3100 Added......................................................51586 80.10 (c) removed; (d), (e) and (f) redesignated as (c), (d) and (e).........................................................3572 (d) amended....................................................14479 80.21 (j)(1) through (4) amended...................................14479 100.120 Removed....................................................27778 100.130 Removed....................................................27778 100.135 Removed....................................................27778 100.140 Removed....................................................27778 100.145 Removed....................................................27778 100.150 Removed....................................................27778 100.160 Removed....................................................27778 101 Technical correction...........................................21074 Request denial.................................................37502 Authority citation revised.....................................43446 101.9 (c)(8)(v) amended; eff. 4-19-96...............................8779 (c)(7)(ii) and (g)(9) amended..................................14479 (j)(1)(i) revised; (j)(18) added...............................40978 101.10 Revised; eff. 5-2-97........................................40332 101.13 (j)(1)(i)(B) amended........................................11731 (q)(5) introductory text revised; eff. 5-2-97..................40332 (b) introductory text and (q)(5) introductory text correctly revised; eff. 5-2-97...............................................67452 101.14 (d)(2)(vii)(B) and (3) introductory text revised; (d)(3)(i) added; eff. 5-2-97.........................................40332 101.17 (c) revised; interim........................................20100 101.33 Removed.....................................................27779 101.36 (b)(3)(v) amended; eff. 4-19-96..............................8779 (b)(3)(ii) corrected...........................................10280 (f) revised....................................................40979 101.43 (a)(1), (2) and (3) revised; eff. 8-18-97...................42759 101.44 (c) revised; eff. 8-18-97...................................42760 101.45 (c) and (i) amended.........................................14479 Revised; eff. 8-18-97..........................................42760 101.54 (e)(1) introductory text and (2) introductory text amended 11731 101.62 (b)(1) introductory text revised; eff. 1-1-98...............59001 101.79 Revised; eff. 4-19-96........................................8779 (b)(3) corrected........................................43119, 48529 Clarification..................................................49964 (b)(3) corrected; CFR correction...............................55567 101.80 Added; eff. 1-1-98..........................................43446 101.103 Removed....................................................27779 101 Appendixes C and D added; eff. 8-18-97.........................42761 102.23 (c)(5) amended..............................................14479 103 Removed........................................................27779 103.35 (b), (d)(3)(v) introductory text, (A)(3), (E)(3), (G)(3) and (vi) amended...........................................14479 104.19 Removed.....................................................27779 105.67 Removed.....................................................27779 Regulation at 61 FR 27779 eff. date confirmed..................48963 105.69 Removed.....................................................27779 Regulation at 61 FR 27779 eff. date confirmed..................48963 106.120 (a) and (b) amended........................................14479 107.50 (e)(1) and (2) amended......................................14479 107.240 (b) amended................................................14479 107.250 Introductory text amended..................................14479 108.5 (a)(1) amended...............................................14479 108.25 (c)(1) and (2) amended......................................14479 108.35 (c)(1), (2) introductory text, (ii) and (g) amended.........14480 109.5 Removed......................................................27779 109.30 (b) and (d) amended.........................................14480 110.110 (e) amended................................................14480 114.3 (b) amended..................................................14245 123 Meetings........................................................9100 131.122 Removed; eff. 1-1-98.......................................59002 131.123 Removed; eff. 1-1-98.......................................59002 131.132 Removed; eff. 1-1-98.......................................59002 131.135 Effective date note reinstated; CFR correction.............48405 Removed; eff. 1-1-98...........................................59002 131.136 Removed; eff. 1-1-98.......................................59002 131.138 Removed; eff. 1-1-98.......................................59002 131.143 Effective date note reinstated; CFR correction.............48405 Removed; eff. 1-1-98...........................................59002 131.144 Removed; eff. 1-1-98.......................................59002 131.146 Removed; eff. 1-1-98.......................................59002 131.149 (a) amended; eff. 1-1-98...................................59002 131.185 Removed; eff. 1-1-98.......................................59002 131.187 Removed; eff. 1-1-98.......................................59002 133.131 Removed; eff. 1-1-98.......................................59002 136 Technical correction...........................................40513 Clarification..................................................46714 136.115 (a)(1) revised; eff. 1-1-98.................................8796 (a)(3) amended.................................................14245 137 Technical correction...........................................40513 [[Page 301]] Clarification..................................................46714 137.165 (a) revised; eff. 1-1-98....................................8796 137.185 (a) revised; eff. 1-1-98....................................8796 137.230 Removed....................................................27779 137.235 (a)(1) revised; eff. 1-1-98.................................8796 Removed........................................................27779 137.240 Removed....................................................27779 137.245 Removed....................................................27779 137.260 (a)(1) revised; eff. 1-1-98.................................8796 137.305 (a)(1) revised; eff. 1-1-98.................................8796 137.350 (a)(1) revised; eff. 1-1-98.................................8796 139 Technical correction...........................................40513 Clarification..................................................46714 139.115 (a)(1) revised; eff. 1-1-98.................................8797 139.122 (a)(3) amended; eff. 1-1-98.................................8797 139.155 (a)(1) revised; eff. 1-1-98.................................8797 161.131 Removed....................................................27779 161.132 Removed....................................................27779 161.133 Removed....................................................27779 161.134 Removed....................................................27779 161.135 Removed....................................................27779 161.137 Removed....................................................27779 161.138 Removed....................................................27779 161.139 Removed....................................................27779 161.140 Removed....................................................27779 161.190 (a)(7)(iii) amended........................................14480 164.150 (c) revised.................................................9325 165.110 (b)(4)(i)(A) table and (iii)(A) through (D) amended; (b)(4)(iii)(E), (F) and (G) revised; eff. 9-23-96..........13264 (a)(2)(iv), (vii), (2), (b)(4)(i)(C), (iii)(E) introductory text, (2)(iii), (6)(iii), (11)(iii) and (F) amended................14480 172 Nomenclature change............................................14482 Technical correction...........................................27004 172.133 (a)(2) amended.............................................14245 (b)(3) and (4) added; (c)(2) revised...........................26788 172.210 (b)(3) amended.............................................14245 172.320 (b)(2) and (c)(1) amended..................................14480 172.345 Revised.....................................................8807 (d) revised....................................................27779 172.515 (b) amended................................................14245 172.804 (c)(23) amended............................................14480 Introductory text and (c) revised; (b) amended; (d) removed; (e) and (f) redesignated as (d) and (e)............................33656 172.809 Added......................................................65941 172.841 (b) amended................................................14480 172.867 Added.......................................................3171 (d), (e)(1) and (2)(iv) corrected..............................11546 173 Nomenclature change............................................14482 Technical correction....................................25392, 27004 173.45 (a) and (c) revised...........................................386 173.69 Redesignated as 173.300.....................................14245 (a) amended....................................................14480 173.300 Redesignated from 173.69...................................14245 173.310 (c) amended................................................14245 173.315 (a)(2) table amended................................46376, 46377 173.325 Added......................................................17829 173.340 (a)(4) table amended.........................................632 173.357 (a)(2) table amended.................................4873, 14245 175 Nomenclature change............................................14482 Technical correction...........................................27004 175.105 (c)(5) table amended.....................2113, 6940, 9904, 42379 175.300 (b)(3)(viii)(b) amended....................................29474 (b)(3)(vii)(a) amended.........................................37208 175.320 (b)(3)(i) table amended....................................14246 176 Nomenclature change............................................14482 Technical correction...........................................27004 176.170 (a)(5) table amended......................10452, 25394, 37209, 58629 (b)(2) table amended....................................14246, 14480 (b)(2) amended..........................................14246, 14480 176.210 (d)(3) amended.............................................14246 177 Nomenclature change............................................14482 Technical correction...........................................27004 177.1210 (b)(5) table amended......................................14480 177.1345 (b)(1) amended............................................14481 177.1390 (c)(3)(i)(a)(1) amended...................................14481 177.1480 (b)(2) amended............................................14481 177.1500 (c)(5)(i) amended.........................................14481 (a)(15) added; (b) table amended...............................34371 (a)(16) added; (b) table and (c)(5)(ii) amended................53853 177.1520 (b) amended........................................14246, 14481 (b) table amended..................14246, 14481, 28050, 37210, 51365 (a)(3)(i)(a)(3) added; (c) table amended.......................59330 177.1550 (d)(2)(ii) amended........................................14481 177.1556 Added.....................................................42381 177.1630 (e)(4) amended............................................46718 177.1637 Added.....................................................14965 177.1655 (a) and (b) table revised.................................29475 177.2450 (b)(2) and (3) amended....................................14481 177.2600 (c)(4)(i) amended.........................................14246 (c)(4)(ii)(b) amended..........................................46544 (c)(4)(ix) amended.............................................60535 178 Nomenclature change............................................14482 Technical correction...........................................27004 [[Page 302]] 178.1010 (b)(45) and (c)(39) added.................................28053 (b)(46) and (c)(40) added......................................31397 178.2010 (b) table amended......1831, 14246, 46545, 46546, 56892, 65944, 66918, 68623 178.3295 Table amended...............................33847, 51588, 65943 178.3297 (e) table amended.....................2116, 14246, 48624, 64991 (c) amended....................................................14481 178.3570 (a)(3) table amended.................................1713, 1830 178.3725 Added.....................................................43157 178.3780 (b)(1) amended............................................14481 178.3860 (b) table amended.........................................25396 (b) table corrected............................................42381 179.21 (b)(2)(ii) and (iii) amended................................14246 179.41 Added.......................................................42383 179.45 (b) introductory text, (5) and (d) amended..................14246 180 Heading revised................................................14246 Nomenclature change............................................14482 Technical correction...........................................27004 180.22 (b), (e) and (f)(1) amended.................................14246 180.25 (a) revised..................................................7991 181 Nomenclature change............................................14482 Technical correction...........................................27004 182.10 Table amended...............................................14246 182.1866 Removed...................................................43450 182.5013--182.5997 (Subpart F) Removed.............................27779 182.5484 Redesignated from 182.8458................................14246 182.5697 Heading and (a) amended...................................14246 182.8458 Redesignated as 182.5484..................................14246 184.1063 Added.....................................................45889 184.1193 (c) amended...............................................14247 184.1259 Heading and (a) revised...................................36290 184.1311 (a), (b) and (c) revised..................................40319 184.1372 (a) revised...............................................43450 184.1387 Added......................................................7704 184.1634 (a) amended...............................................14247 184.1866 Added.....................................................43450 186.1025 Removed...................................................27779 189 Nomenclature change............................................14482 Technical correction....................................27004, 29650 189.301 Added.......................................................4820 197 Removed........................................................27779 200.100 Removed....................................................29476 200.101 Removed....................................................29476 201 Comment period extension.......................................38046 Compliance date extension......................................68623 201.64 Added; eff. 4-22-97.........................................17806 201.320 Added; interim.............................................20100 211 Compliance date extension......................................37679 250.104 Removed....................................................29476 250.203 Removed....................................................29476 310.101 Removed....................................................29476 310.304 Removed....................................................29477 310.545 (a)(6)(ii)(B) stayed in part................................9571 (a)(6)(iv)(C) and (d)(25) added; (d) introductory text revised 25142 312.2 (b)(6) added.................................................51529 312.20 (c) added...................................................51529 312.23 (f) added...................................................51529 312.30 Introductory text amended...................................51529 312.42 (b)(5) added................................................51530 312.53 (c)(1)(vi)(d) revised.......................................57280 312.54 Added.......................................................51530 312.60 Amended.....................................................51530 312.62 (b) revised.................................................57280 312.130 (d) added..................................................51530 314.430 (d) redesignated as (d)(1); (d)(2) added...................51530 328.10 (f) redesignated as (g); new (f) added......................58630 331 Comment period extension.......................................38046 331.10 (a) revised; eff. 2-10-97....................................4823 331.20 Removed; new 331.20 redesignated from 331.21 and revised; eff. 2-10-97................................................4823 331.21 Redesignated as 331.20; new 331.21 redesignated from 331.29 and revised; eff. 2-10-97...................................4823 331.22 Removed; eff. 2-10-97........................................4823 331.23 Removed; eff. 2-10-97........................................4823 331.24 Removed; eff. 2-10-97........................................4823 331.25 Removed; eff. 2-10-97........................................4823 331.26 Removed; eff. 2-10-97........................................4823 331.29 Redesignated as 331.21; eff. 2-10-97.........................4823 331.30 (c)(5) and (f) removed; (c)(6), (7) and (g) redesignated as (c)(5), (6) and (f)........................................17806 331.80 (a)(1) revised; eff. 2-10-97.................................4823 332 Authority citation revised......................................8838 332.3 Added; eff. 3-5-97............................................8838 332.30--332.31 (Subpart D) Redesignated as 332.30--332.31 (Subpart C); eff. 3-5-97.............................................8838 332.30 (a), (b) and (c) redesignated as (b), (c) and (d); heading and new (b) revised; new (a) added; eff. 3-5-97.............8838 333.150 (c)(2) heading and (3) added; eff. 11-17-97................58472 [[Page 303]] 341.70 Added.......................................................15703 341.76 (d)(2)(i) and (e) removed; (d)(2)(ii) redesignated as (d)(2) heading.............................................25146 355.3 (e) revised; eff. 4-7-97.....................................52286 355.10 (a)(1) heading, (b)(1) heading, (2) heading and (c)(1) heading amended; eff. 4-7-97...............................52286 355.50 Regulation at 60 FR 52508 eff. date delayed to 4-7-97.......52285 (c)(1) and (2) revised; (d)(1)(i) heading and (ii) heading amended; eff. 4-7-97...............................................52287 355.70 (a) stayed in part 9-23-96 through 10-7-97..................65946 369.21 (d) amended; interim........................................20101 452.150 Redesignated as 452.150a; new 452.150 added................34726 452.150a Redesignated from 452.150.................................34726 452.150b Added.....................................................34726 500.23 Added.......................................................37681 500.24 Added.......................................................37681 500.49 Removed.....................................................37682 500.50 Added.......................................................19544 501.17 (c) revised; interim........................................20101 505 Removed........................................................37682 507 Removed........................................................37682 508 Removed........................................................37682 508.35 (c)(1), (2) introductory text and (ii) amended..............14481 510.120 Removed....................................................37682 510.200 (Subpart C) Removed........................................37682 510.310 Removed....................................................37682 510.413 Removed....................................................37682 510.515 (b)(7), (17), (25) and (29) removed; (b)(10) and (13) redesignated as (b)(1) and (2); (c) table amended..........35950 510.600 (c)(1) table and (2) table amended...259, 515, 4735, 5506, 8872, 15703, 17565, 18672, 21075, 24441, 46547, 58630, 58631, 59003, 63710, 63711, 66580, 68146 520 Technical correction...........................................43964 520.45a (a)(2) amended..............................................4875 520.82a (b) amended.................................................8873 520.82b (b) amended.................................................8873 520.154b (b) amended...............................................66581 520.222 (c) amended.................................................8873 520.309 Added......................................................66581 520.447 (c)(3) amended; (d) added..................................59003 520.500 Removed....................................................34728 520.580 (b)(2) amended.............................................34728 520.620a Removed...................................................34728 520.620b Removed...................................................34728 520.622a (a) amended...............................................34728 520.622b (b)(2) revised............................................34728 520.622c (b)(5) amended.............................................8873 520.784 (b) amended.................................................8873 520.813 Added......................................................56893 520.863 (b) amended.................................................8873 520.905a (d)(2) heading revised; (d)(2)(i)(B) amended..............29478 520.905c (d)(2) heading revised; (d)(2)(iii) amended...............29478 520.960 (b) amended.................................................5506 520.1120a (c) amended...............................................8873 520.1120b (c) amended...............................................8873 520.1193 (c)(2) and (3) revised....................................39868 520.1196 Heading revised; (c)(1)(iii) amended......................15186 (c)(1)(ii) amended.............................................59004 520.1197 Added.....................................................67452 520.1445 (c)(2) amended............................................43654 520.1448a (c)(4)(iii) amended......................................24444 (a)(4)(iii) and (d)(4)(iii) amended............................53615 520.1468 (b) amended................................................5506 520.1484 (b) revised; (c)(3) amended...............................31027 (c)(3) amended.................................................31399 520.1485 (b) revised; (d)(3) amended...............................31398 520.1520 Removed...................................................34728 520.1628 (b) amended................................................5506 520.1629 (a)(2) and (b)(2) amended..................................5506 520.1630 (b) amended................................................5506 520.1631 (b) amended................................................5506 520.1660d (a)(7) and (b)(5) added...................................2915 520.1660d (a)(7) revised; (e)(1)(ii)(A)(3), (B)(3), (C)(3), (iii)(C) and (iv)(C) amended...............................52690 520.1720a (b)(1) amended............................................8873 520.1720b (b) amended...............................................8873 520.1720c (b) amended...............................................8873 520.1805 (b) amended................................................8873 520.1872 (c)(1)(ii) amended........................................29651 520.2002 (c) amended................................................5506 520.2022 Removed...................................................34728 520.2043 (b)(2) revised............................................29477 (b)(2) amended.................................................63712 520.2122 (b)(2) amended.............................................5506 520.2160a Removed..................................................34728 520.2160b Removed..................................................34729 520.2160c Removed..................................................34729 520.2160d Removed..................................................34729 520.2220a (b) amended...............................................4875 520.2220b (b)(1) amended............................................4875 520.2220c (c) amended...............................................4875 [[Page 304]] 520.2220d (b) amended...............................................4875 (c)(2) amended.................................................46719 520.2260a (b)(1) amended............................................4875 520.2260b (b)(1) amended............................................4875 520.2260c (a) amended...............................................4875 520.2325a (b) added; (d) removed; (c), (e) and (f) redesignated as (a), (c) and (d); new (a) revised; new (d) amended.........24443 (a) revised....................................................63711 520.2362 (c) amended................................................8873 520.2480 Removed...................................................34729 520.2520a (b) amended..............................................34729 520.2520c Removed..................................................34729 520.2520d Removed..................................................34729 520.2610 (b) amended..........................................5506, 8873 520.2611 (b) amended..........................................5506, 8873 520.2612 (b) amended................................................8873 522.82 (b) amended..................................................8873 522.147 Added......................................................48830 522.281 Removed....................................................34729 522.313 (d)(3)(ii) revised; (d)(4) and (5) redesignated as (d)(5) and (6); new (d)(4) added..................................35130 (d)(7) added...................................................66583 522.314 Added......................................................29479 522.740 Removed....................................................34729 522.770 Added......................................................53321 522.784 (b) amended.................................................8873 522.842 (b) amended.................................................5506 522.863 (b) amended.................................................8873 522.883 (c) amended..................................................260 522.914 (b) amended.................................................5506 522.955 Added......................................................42383 522.960a (c) amended................................................5506 522.960b (c) amended................................................5507 522.960c (b) amended................................................5507 522.1004 Added.....................................................68147 522.1044 (b), (d)(2)(i) and (3)(i) revised.........................24441 522.1055 (b) amended...............................................18672 522.1078 (b) amended...............................................37682 522.1145 (a)(2) amended............................................59003 522.1155 (b) amended................................................8873 522.1182 (a)(4)(i) amended.........................................18672 522.1290 (b) amended...............................................66582 522.1335 Added.....................................................21075 522.1468 (b) amended................................................5507 522.1660 (b), (c)(1)(iii) and (2)(iii) amended..............31028, 36291 522.1720 (b)(1) amended.............................................8873 (b)(1) and (2) revised.........................................54333 522.1850 (c)(1) revised; (c)(2)(i) and (ii) amended................54333 522.1940 (b) and (d)(1)(iii) amended................................5507 522.2002 (c) amended................................................5507 522.2005 Added.....................................................66582 522.2012 (b) amended................................................5507 522.2022 Removed...................................................34729 522.2120 (b) amended................................................5507 (b) revised; (d)(4) amended....................................31028 522.2220 (a)(2)(i) amended..........................................4875 522.2474 Added.....................................................25785 522.2477 (c)(3) added..............................................29480 (c)(3) heading and (iii) revised...............................41499 522.2478 Added.....................................................14482 (a) amended....................................................29479 522.2480 Removed...................................................34729 522.2610 (a)(2) and (b)(2) amended............................5507, 8873 522.2615 (b) amended; (d) removed..................................29480 522.2662 (b) amended...............................................46548 524.154 (a)(2) amended..............................................8873 524.155 (a)(1) amended..............................................8873 524.660a (b) amended................................................5507 524.660b (b) amended................................................5507 524.960 (b) amended.................................................5507 524.981d (b) amended................................................5507 524.1044b (b) amended..............................................48624 524.1484e (b) amended...............................................5507 524.1600a (b) amended..............................................63712 524.1742 (b) amended................................................8873 529.810 Removed....................................................34729 529.1044a (b) amended..............................................17830 530 Added..........................................................57743 556.113 Amended....................................................66583 556.150 Revised....................................................67453 556.225 Added......................................................53321 556.228 Added......................................................56893 556.275 (c) added..................................................29478 556.283 Added......................................................42383 556.300 (a) amended................................................24441 556.430 Revised....................................................31399 556.500 Revised....................................................67453 556.600 Revised....................................................31028 556.685 Added......................................................24443 556.720 Revised....................................................67453 556.735 Revised....................................................68148 558.4 (d) table amended............................................68148 558.15 (g)(1) table amended........................................51589 558.55 (d)(2) table amended...................................515, 35950 558.58 (d)(1) table amended...........................4875, 18082, 35951 558.76 (d)(3)(xiv) added...........................................43451 (d)(3)(xiv) revised............................................66584 558.78 (a)(2), (d)(1) table and (2)(ii) amended....................18082 558.95 (b)(3)(iv)(b) amended.........................................515 (b)(1)(xiii)(b) amended........................................18082 (b)(4)(iii) added..............................................43655 [[Page 305]] 558.120 (a)(1) and (2) amended.......................................515 (c)(1)(iii)(b) amended.........................................18082 558.128 (a) amended................................................18082 (a), (b) and (c)(1) revised; (c)(2) and (3) removed; (c)(4) and (5) redesignated as (c)(2) and (3).............................35952 (c)(4) amended.................................................36291 (c)(2) corrected...............................................53615 558.140 Added......................................................35954 558.145 (a)(1) and (2) amended.....................................18082 558.155 Heading, (d)(2) and (3) revised.............................2415 558.175 (c)(2)(ii) revised.........................................35954 558.185 (a)(1) removed.............................................34729 558.195 (d) table amended..........................................35954 558.258 (c)(2) introductory text and (3) introductory text revised; (c)(2)(iii) and (3)(iii) amended..................29478 558.265 (c)(2)(ii) added...........................................21076 (c)(2)(iii) added..............................................24694 558.274 (c)(1) table amended.......................................35955 558.300 (a) revised; (c)(2) through (5) added......................32652 558.311 (b)(7)(iii) and (e)(1) table corrected......................4349 (b)(2) amended..................................................4875 558.325 (c)(4)(iii) added..........................................32653 558.340 (a) amended................................................18082 558.355 (b)(5) amended..............................................4875 (b)(8), (9), (f)(1)(iv)(b), (v)(b), (xiv)(b), (xv)(b), (xvi)(b) amended; (b)(10) added....................................18082 (f)(3)(iii)(b) and (v)(b) amended..............................24444 (f)(3)(x)(c) amended...........................................51003 558.366 (a) revised; (c) table amended..............................1832 (c) table amended.......................................14021, 14483 558.367 Removed....................................................34729 558.450 Revised....................................................51590 558.485 (a)(16) removed............................................34729 558.515 (a), (d)(1)(iii)(b), (iv)(b), (v)(b) and (vi)(b) amended 18082 (d)(1)(iii), (iv) and (v)(b) revised...........................35956 (d)(2) revised.................................................51593 558.530 (d)(2), (3) and (4) redesignated as (d)(4), (5) and (6); (a) and new (d)(4) revised; new (d)(2) and new (3) added; new (d)(6)(i)(a) through (d) redesignated as (d)(6)(i)(A) through (D)................................................35956 (d)(5)(xxiv) added.............................................43451 558.550 (b)(1)(vii)(c), (ix)(c), (xv)(c) and (xvi)(c) amended......18082 558.555 (b)(2) added...............................................29481 (b)(2)(ii) amended.............................................43451 (b)(3) added...................................................66584 558.565 Removed....................................................34729 558.582 (a) amended................................................18082 558.618 Added......................................................68148 558.625 (b)(25) amended.............................................4875 (b)(79) amended................................................17566 (b)(72) removed................................................34729 (b)(76) removed................................................58631 (f)(1)(vi)(e) added............................................67713 558.630 (b)(10) amended............................................34729 558.635 (b)(1) amended.............................................30133 558.680 (c)(1) table amended.......................................35957 570.22 Removed.....................................................37682 573.460 (a) introductory text, (1), (2), (b), (c) introductory text, (1) and (2) redesignated as (a)(1) introductory text, (i), (ii), (2), (3) introductory text, (i) and (ii); new (b) added..............................................15704 573.625 Added..........................................................5 573.870 Introductory text and (b) amended..........................11547 582.1666 (b) revised...............................................19544 584.700 Added......................................................43453 589.1001 Added.....................................................19544 600.3 (t) revised..................................................24232 601.2 (a) existing text designated as (a) introductory text; new (a) introductory text amended; (a)(1) through (4) and (c) added......................................................24232 601.22 Amended.....................................................24233 601.30 Removed.....................................................40154 601.31 Removed.....................................................40154 601.32 Removed.....................................................40154 601.51 (d) redesignated as (d)(1); (d)(2) added....................51530 606.100 (b)(19) added..............................................47422 Regulation at 61 FR 47422 eff. date corrected to 2-7-97........66919 606.160 (b)(1)(vii) and (viii) added...............................47422 Regulation at 61 FR 47422 eff. date corrected to 2-7-97........66919 610.45 (d) added...................................................47423 Regulation at 61 FR 47423 eff. date corrected to 2-7-97........66919 610.46 Added.......................................................47423 Regulation at 61 FR 47423 eff. date corrected to 2-7-97........66919 610.47 Added.......................................................47423 [[Page 306]] Regulation at 61 FR 47423 eff. date corrected to 2-7-97........66919 610.64 Revised.....................................................57330 620 Removed........................................................40154 630 Removed........................................................40155 640.110--640.114 (Subpart K) Removed...............................40155 650 Removed........................................................40155 660.100--660.105 (Subpart K) Removed...............................40155 680.1--680.3 (Subpart A) Heading removed...........................40155 680.10--680.16 (Subpart B) Removed.................................40155 680.20--680.26 (Subpart C) Removed.................................40155 700.10 Removed.....................................................27779 730.3 Amended......................................................14481 740.11 (c) revised; interim........................................20101 801.63 Added; interim..............................................20101 801.126 Added; eff. 8-28-97........................................44615 801.403 Removed....................................................37683 801.408 Removed....................................................37683 801.425 Removed; interim...........................................20101 801.427 Removed....................................................37683 801.433 Added; interim.............................................20101 803 Regulation at 60 FR 63597 eff. date delayed to 7-31-96.........16043 803.3 (n)(4) stayed................................................38347 803.19 (f) and (g) added; eff. 8-28-97.............................44615 803.55 (b)(9) and (10) stayed......................................39869 803.57 Stayed......................................................38347 803.58 Stayed......................................................38347 804.25 (c) added; eff. 8-28-97.....................................44615 804.30 Removed.....................................................38347 807 Technical correction...........................................47550 807.3 Regulation at 60 FR 63606 eff. date delayed to 7-31-96.......16043 (r) stayed.....................................................38347 807.20 Regulation at 60 FR 63606 eff. date delayed to 7-31-96......16043 (a)(6) stayed..................................................38347 807.22 Regulation at 60 FR 63606 eff. date delayed to 7-31-96......16043 807.40 Regulation at 60 FR 63606 eff. date delayed to 7-31-96......16043 Stayed.........................................................38347 807.65 (j) added; eff. 8-28-97.....................................44615 808 Authority citation revised.....................................52654 808.1 (d)(10) added; eff. 6-1-97...................................52654 810 Added; eff. 5-19-97............................................59018 812 Authority citation revised.....................................52654 812.1 (a) amended; eff. 6-1-97.....................................52654 812.20 (a)(1) revised; (a)(4) added................................51530 812.35 (a) amended.................................................51531 812.38 (b)(4) added................................................51531 812.47 Added.......................................................51531 812.140 (a)(3) introductory text revised; (a)(3)(i) amended........57280 814 Authority citation revised.....................................51531 814.3 (k) and (l) added............................................15190 (m) and (n) added..............................................33244 814.9 (d) redesignated as (d)(1); (d)(2) added.....................51531 814.47 Added.......................................................15190 814.100--814.126 (Subpart H) Added.................................33244 814.102 Stayed.....................................................55741 814.104 Stayed.....................................................55741 814.106 Stayed.....................................................55741 814.108 Stayed.....................................................55741 814.110 (a) stayed.................................................55741 814.112 (b) stayed.................................................55741 814.116 (b) stayed.................................................55741 814.118 (d) stayed.................................................55741 814.120 (b) stayed.................................................55741 814.124 (b) stayed.................................................55741 814.126 (b)(1) stayed..............................................55741 820 Technical correction...........................................47550 Revised; eff. 6-1-97...........................................52654 820.1 (f) added; eff. 8-28-97......................................44615 862.2230 (b) revised................................................1119 866.2160 (b) revised................................................1119 866.3720 (b) revised................................................1119 866.5520 (b) revised................................................1119 866.5530 (b) revised................................................1119 866.5860 (b) revised................................................1119 868.1100 (b) revised................................................1119 868.1575 (b) revised................................................1119 868.1870 (b) revised................................................1119 868.1975 (b) revised................................................1119 868.2300 (b) revised................................................1119 868.2320 (b) revised................................................1119 868.2340 (b) revised................................................1119 868.2350 (b) revised................................................1119 868.2610 (b) revised................................................1119 868.2620 (b) revised................................................1119 868.2700 (b) revised................................................1119 868.2875 (b) revised................................................1119 868.2885 (b) revised................................................1119 868.2900 (b) revised................................................1120 868.5100 (b) revised................................................1120 868.5110 (b) revised................................................1120 868.5240 (b) revised................................................1120 868.5300 (b) revised................................................1120 868.5310 (b) revised................................................1120 868.5320 (b) revised................................................1120 868.5375 (b) revised................................................1120 868.5400 (c) revised...............................................50706 868.5460 (b) revised................................................1120 [[Page 307]] 868.5530 (b) revised................................................1120 868.5540 (b) revised................................................1120 868.5550 (b) revised................................................1120 868.5570 (b) revised................................................1120 868.5580 (b) revised................................................1120 868.5590 (b) revised................................................1120 868.5600 (b) revised................................................1120 868.5770 (b) revised................................................1120 868.5780 (b) revised................................................1120 868.5790 (b) revised................................................1120 868.5810 (b) revised................................................1120 868.5820 (b) revised................................................1120 868.5860 (b) revised................................................1120 868.5975 (b) revised................................................1120 868.5995 (b) revised................................................1120 868.6400 (b) revised................................................1121 868.6820 (b) revised................................................1121 868.6885 (b) revised................................................1121 870.1350 (c) revised...............................................50706 870.1360 (c) revised...............................................50706 870.2390 (b) revised................................................1121 870.2600 (b) revised................................................1121 870.2620 (b) revised................................................1121 870.2640 (b) revised................................................1121 870.2810 (b) revised................................................1121 870.3650 (b) revised................................................1121 870.3670 (b) revised................................................1121 870.3690 (b) revised................................................1121 870.3850 (c) revised...............................................50706 870.3935 (b) revised................................................1121 870.3945 (b) revised................................................1121 870.5300 (c) revised...............................................50706 872.1840 (b) revised................................................1121 872.1850 (b) revised................................................1121 872.3400 (c) revised...............................................50706 872.3420 (c) revised...............................................50707 872.3480 (c) revised...............................................50707 872.3500 (c) revised...............................................50707 872.3560 (c) revised...............................................50707 872.3820 (c) revised...............................................50707 872.4630 (b) revised................................................1121 872.6390 (b) revised................................................1121 874.1060 (b) revised................................................1121 874.1080 (b) revised................................................1121 874.4140 (b) revised................................................1122 874.4175 (b) revised................................................1122 874.4350 (b) revised................................................1122 874.4770 (b) revised................................................1122 876 Authority citation revised...............................1122, 50707 876.1075 (b) revised................................................1122 876.1400 (b) revised................................................1122 876.1500 (b) revised................................................1122 876.1800 (b) revised................................................1122 876.4590 (b) revised................................................1122 876.4890 (b) revised................................................1122 876.5090 (b) revised................................................1122 876.5130 (b) revised................................................1122 876.5220 (c) revised...............................................50707 876.5270 (c) revised...............................................50707 876.5450 (b) revised................................................1122 876.5520 (b) revised................................................1122 876.5540 (b)(3) revised; (b)(4) added...............................1122 878.4450 (b) revised................................................1123 878.4810 (b) revised................................................1123 878.5350 (b) revised................................................1123 878.5910 (b) revised................................................1123 880.2720 (b) revised................................................1123 880.2900 (b) revised................................................1123 880.5560 (b) revised................................................1123 880.5580 Added.....................................................64617 880.5760 (c) revised...............................................50708 880.6320 (b) revised................................................1123 880.6760 Revised; eff. 9-3-96.......................................8439 882.1410 (b) revised................................................1123 882.1825 (c) revised...............................................50708 882.4325 (b) revised................................................1123 882.5150 (c) revised...............................................50708 882.5850 (c) revised...............................................50708 884.1550 Revised....................................................1123 884.1640 (b) revised................................................1123 884.1690 (b) revised................................................1123 884.1700 (b) revised................................................1124 884.1720 (b) revised................................................1124 884.1730 (b) revised................................................1124 884.2620 (c) revised...............................................50708 884.2685 (c) revised...............................................50708 884.4250 (c) revised...............................................50708 884.4270 (c) revised...............................................50708 884.4530 (b) revised................................................1124 884.5050 (c) revised...............................................50709 884.5150 (b) revised................................................1124 884.5225 (c) revised...............................................50709 884.5425 (b) revised...............................................67714 884.5435 (b) revised...............................................67714 884.5900 (b) revised................................................1124 886.1405 (b) revised................................................1124 886.1750 (b) revised................................................1124 886.1760 (b) revised................................................1124 886.3200 Revised....................................................1124 888.1100 (b) revised................................................1124 888.3000 (b) revised................................................1124 888.3120 (c) revised...............................................50709 888.3180 (c) revised...............................................50709 888.3200 (c) revised...............................................50709 888.3210 (c) revised...............................................50709 888.3220 (c) revised...............................................50709 888.3300 (c) revised...............................................50709 888.3310 (c) revised...............................................50710 888.3370 (c) revised...............................................50710 888.3380 (c) revised...............................................50710 [[Page 308]] 888.3480 (c) revised...............................................50710 888.3540 (c) revised...............................................50710 888.3550 (c) revised...............................................50710 888.3570 (c) revised...............................................50710 888.3580 (c) revised...............................................50711 888.3640 (c) revised...............................................50711 888.3680 (c) revised...............................................50711 888.3790 (c) revised...............................................50711 888.5960 (b) revised................................................1125 890.1575 (b) revised................................................1125 890.1600 (b) revised................................................1125 890.1615 (b) revised................................................1125 890.3175 (b) revised................................................1125 890.3610 (c) revised...............................................50711 890.3760 (b) revised................................................1125 890.3910 Revised; eff. 9-3-96.......................................8439 890.5380 (b) revised................................................1125 890.5410 (b) revised................................................1125 890.5660 (b) revised................................................1125 890.5925 (b) revised................................................1125 890.5940 (b) revised................................................1125 890.5950 (b) revised................................................1125 890.5975 (b) revised................................................1125 892.1700 (b) revised................................................1125 892.1760 (b) revised................................................1125 892.1770 (b) revised................................................1125 892.1830 (b) revised................................................1125 892.1880 (b) revised................................................1125 892.5780 (b) revised................................................1125 892.6500 (b) revised................................................1125 897 Added; eff. 8-28-97............................................44615 897.14 Eff. in part 2-28-97........................................44616 897.34 Eff. in part 2-28-98........................................44617 Regulation at 61 FR 44617 eff. date corrected to 8-28-98.......47550 1000.3 Figure 1 correctly revised..................................13422 1002.1 Table 1 correctly revised...................................13423 1002.3 Corrected...................................................13424 1240 Meetings.......................................................9100 1250.51 (d) amended................................................14481 Chapter II 1301 Comment request...............................................68624 1308.12 (c)(26) redesignated as (c)(27); new (c)(26) added.........56894 1308.24 (i) table revised..........................................13690 1309.02 (f) revised................................................40989 Corrected......................................................41836 (f) corrected..................................................48830 Regulation at 61 FR 40989 withdrawn............................52287 1309.21 Revised....................................................32926 1309.22 (b) revised................................................32926 1309.28 Added......................................................32926 1309.29 Added......................................................40989 Correctly designated...........................................48830 Regulation at 61 FR 40989 withdrawn............................52287 1309.71 (a)(2) revised.............................................40989 Regulation at 61 FR 40989 withdrawn............................52287 1310.01 (f)(1)(iv)(A) revised......................................40990 Regulation at 61 FR 40990 withdrawn............................52287 1310.03 Existing text designated as (a); (b) added; eff. 4-29-96 14023 1310.04 (f) introductory text and (1)(x) revised...................40990 Corrected......................................................48830 Regulation at 61 FR 40990 withdrawn............................52287 1310.05 (d) added; eff. 4-29-96....................................14024 Corrected......................................................17958 1310.06 (h) added; eff. 4-29-96....................................14024 (b) revised....................................................32926 1310.09 Revised....................................................40990 Regulation at 61 FR 40990 withdrawn............................52287 1310.14 Heading and (a) revised....................................40990 Regulation at 61 FR 40990 withdrawn............................52287 1310.15 Heading, (a) and (d) revised...............................40990 Regulation at 61 FR 40990 withdrawn............................52287 1311 Comment request...............................................68624 1313 Policy statement..............................................13759 1313.02 (d)(1)(iv)(A) revised......................................40991 Regulation at 61 FR 40991 withdrawn............................52287 1313.23 (c) revised................................................51004 1313.32 Heading correctly revised..................................17566 1316.01--1316.13 (Subpart A) Authority citation correctly revised 17566 1997 21 CFR 62 FR Page Chapter I Chapter I Comment response.........................................49881 1 Authority citation revised.......................................51512 1.31 Removed.......................................................39440 1.35 Removed.......................................................39440 2 Authority citation revised.......................................51512 3 Authority citation revised.......................................51512 5 Authority citation revised.........................................923 5 Authority citation revised.......................................51512 5.10 (a)(38) added.................................................28628 (a)(39) added..................................................33349 [[Page 309]] 5.20 (h) revised.....................................................923 (f)(4) added...................................................48757 5.22 (a)(13)(i) through (v) revised; (a)(13)(vi), (vii) and (viii) added.......................................................2554 (a)(10)(i), (ii), (iv) and (v) revised.........................67270 5.23 (b) revised....................................................2554 (c)(1) and (4) revised.........................................67270 5.25 (a)(6) revised.................................................2554 (a)(2) and (b) revised.........................................67270 5.26 (g) revised....................................................2554 (c) revised....................................................67270 5.28 Revised.......................................................67270 5.30 (a)(2) and (c)(3) revised......................................2554 (b) and (c)(4) revised.........................................67270 5.31 (a)(2)(i), (ii), (iii), (b)(1), (2), (3), (c)(1), (d)(1), (2), (e)(4), (f)(2) introductory text, (3) and (5)(ii) revised; (a)(2)(iv) removed; (d)(3) added...................2555 (h) added......................................................19493 (c)(3) and (e)(5) revised......................................67271 5.33 (c) revised....................................................2555 (b) revised....................................................67271 5.37 (a)(5)(i) and (ii) revised; (a)(5)(iii) and (iv) added.........2555 (a)(2)(i), (ii) and (iii) and (b)(1), (2) and (3) revised; (a)(2)(iv) and (b)(4) removed......................................67271 5.38 (a)(1) through (6) revised.....................................2555 5.40 Added.........................................................43471 5.44 (a)(1)(iii) and (b)(1)(iii) revised............................2555 5.45 (f)(2) revised.................................................2555 5.45 (b) introductory text, (c)(1), (2) and (e)(1)(i), (ii) and (iii) revised..............................................67271 5.46 Revised.......................................................67271 5.47 (a)(1) and (2) revised........................................67271 5.49 (a) revised...................................................67271 5.50 (a) revised...................................................67271 5.51 (a)(1) and (b)(1) revised.....................................67271 5.52 (a) revised...................................................67271 5.53 (a)(1), (b)(1)(i) and (c) revised.............................67271 5.54 (c) revised....................................................2556 (a) revised....................................................67272 5.55 (c) revised....................................................2556 (a) revised....................................................67272 5.56 (c) revised....................................................2556 5.56 (a) and (b) revised...........................................67272 5.57 (d) revised....................................................2556 (a), (b) and (c) revised.......................................67272 5.58 (c)(1)(i), (ii) and (iii) revised; (c)(1)(iv) removed..........2556 5.59 (a)(1) revised................................................67272 5.60 (a)(7), (8), (9), (b)(6), (7) and (8) revised; (a)(10) and (b)(9) removed; (a)(11), (12), (13), (b)(10), (11) and (12) redesignated as (a)(10), (11), (12), (b)(9), (10) and (11)........................................................2556 (a)(1) through (4), (6) and (b)(1) through (5) revised.........67272 5.70 Revised........................................................2556 5.71 (a)(2), (b)(1), (2), (c)(1) and (2) revised....................2556 5.72 (a) revised....................................................2556 5.73 (a) through (d) revised; (e) and (f) added.....................2556 5.74 (a) and (b) revised; (c) and (d) added.........................2557 5.75 (a), (b) and (c) revised.......................................2557 5.76 (a) through (d) revised........................................2557 5.78 (a)(1) and (2) revised; (a)(3) through (7) added...............2557 (b) revised....................................................67272 5.80 (a)(1)(i), (ii), (b), (c)(1)(i), (ii), (d)(1), (2), (3) and (f) revised; (a)(1)(iii), (c)(1)(iii) and (iv) removed; (e) amended.................................................2557 5.82 (a) revised....................................................2558 5.86 (a) and (b) revised; (c) removed..............................67272 5.87 (a) and (b) revised; (c) removed..............................67272 5.88 Revised.......................................................67272 5.89 (b)(1) amended................................................15110 (a) introductory text and (b) introductory text revised........67272 5.90 Revised.......................................................67273 5.91 Revised.......................................................67273 5.92 Revised.......................................................67273 5.93 (a) and (b) revised............................................2558 5.94 (b)(1), (2) and (3) revised; (b)(4) removed....................2558 5.100 Redesignated as 5.200........................................13821 Added..........................................................48757 5.105 Redesignated as 5.205........................................13824 5.110 Redesignated as 5.210........................................13824 5.115 Redesignated as 5.215........................................13824 5.200 Redesignated from 5.100 and revised..........................13821 5.205 Redesignated from 5.105......................................13824 5.210 Redesignated from 5.110 and revised..........................13824 5.215 Redesignated from 5.115 and revised..........................13824 7 Authority citation revised.......................................51512 10 Technical correction............................................47760 Authority citation revised.....................................51512 [[Page 310]] 10.30 (b) amended..................................................40592 10.40 (b)(1)(ix) revised...........................................40592 11 Added; eff. 8-20-97.............................................13464 12 Authority citation revised......................................51512 13 Authority citation revised......................................51512 14 Authority citation revised......................................51512 15 Authority citation revised......................................51512 16 Authority citation revised...............................51513, 55976 Authority citation corrected...................................60614 16.1 (b)(2) amended................................................40444 (b)(2) amended; eff. 4-28-99...................................55976 17 Authority citation revised......................................51513 19 Authority citation revised......................................51513 20 Technical correction............................................47760 Authority citation revised.....................................51513 20.100 (c)(3) revised..............................................40592 20.112 (a) amended; eff. 4-6-98....................................52249 21 Authority citation revised......................................51513 25 Revised.........................................................40592 Technical correction...........................................47760 Authority citation revised.....................................51513 50 Meeting.........................................................46198 Authority citation revised.....................................51513 50.3 (j) removed; (k) through (n) redesignated as (j) through (m) 39440 50.21 Removed......................................................39440 50.40--50.48 (Subpart C) Removed...................................39440 56 Meeting.........................................................46198 Authority citation revised.....................................51513 58 Authority citation revised......................................51513 60 Authority citation revised......................................51513 70 Authority citation revised......................................51513 71 Technical correction............................................47760 Authority citation revised.....................................51513 71.1 (c) amended...................................................40598 73 Confirmation of effective date..................................12951 Authority citation revised.....................................51513 74.2101 (a) correctly revised; CFR correction......................15389 Authority citation revised.....................................51513 74.2101 (a) correctly revised; CFR correction......................15389 80 Authority citation revised......................................51513 81 Authority citation revised......................................51513 82 Authority citation revised......................................51513 100 Authority citation revised.....................................51513 101 Authority citation revised........................3600, 15342, 51513 101 Technical correction....................................47760, 55331 101.2 (b) and (f) amended; (c)(1), (2), (3) and (5)(iii) removed; (c)(5)(iv) redesignated as (c)(5)(iii); (c)(4) and (5) redesignated as (c)(1) and (2).............................43074 (b), (d)(1) and (f) revised; eff. 3-23-99......................49847 101.3 (g) added; eff. 3-23-99......................................49847 101.4 (a)(1) revised; (g) and (h) added; eff. 3-23-99..............49847 (h)(1) corrected...............................................64634 101.8 Removed......................................................43074 101.9 (j)(4) amended...............................................15342 (k)(2) and (5) removed; (k)(3), (4) and (6) redesignated as (k)(2), (3) and (4); (c)(8)(iii), (v), (d)(7)(i), (j)(6) and new (k)(4) revised; eff. 3-23-99.......................................49848 101.11 Removed......................................................3792 101.12 (h)(12) revised.............................................40598 (b) Table 2 amended; eff. 3-23-99..............................49848 (b) Table 2 amended; eff. 1-1-00...............................63653 (b) Table 2 corrected..........................................66275 101.13 (j)(1)(i)(B) amended........................................31339 (a) and (b) introductory text revised; (q)(3) redesignated as (q)(3)(i); (q)(3)(ii) added; eff. 3-23-99..........................49867 101.14 (a)(4) removed; (a)(5) and (6) redesignated as new (a)(4) and (5); (b)(3)(i) and (d)(3) revised; eff. 3-23-99........49867 101.17 (e) added; eff. 7-15-97......................................2249 101.29 Removed.....................................................43074 101.36 Revised; eff. 3-23-99.......................................49849 101.54 (e)(1) introductory text and (2) introductory text amended 31339 (b)(1), (c)(1) and (e)(1) introductory text revised; eff. 3- 23-99..............................................................49867 Heading revised; (f) and (g) added; eff. 3-23-99...............49880 101.60 (c)(6) amended..............................................15342 (c)(1)(iii)(A) revised; eff. 3-23-99...........................49881 101.65 (d)(2)(ii)(C) and (4)(ii)(B) stayed; eff. 4-1-97 through 1- 1-00.......................................................15391 (b)(4) revised; eff. 3-23-99...................................49858 101.69 (h) revised; (m)(1), (n)(1) and (o)(1) amended..............40598 101.70 (j)(4) added................................................28232 (f) amended....................................................40599 [[Page 311]] 101.80 (c)(2)(ii)(B) revised.......................................63655 101.72 (c)(2)(ii)(A) amended.......................................15342 101.81 Added........................................................3600 (c)(2)(i)(C), (iii)(A), (e)(1) and (2) revised.................15344 101.93 (b) through (e) added; eff. 3-23-99.........................49867 Added..........................................................49886 101.108 (a) and (b) amended........................................15342 102 Authority citation revised.....................................51513 102.33 (c) and (d) amended.........................................15343 105 Authority citation revised.....................................51513 106 Authority citation revised.....................................51513 107 Authority citation revised.....................................51513 108 Authority citation revised.....................................51513 109 Authority citation revised.....................................51514 110 Authority citation revised.....................................51514 111 Added; eff. 7-15-97.............................................2249 111 Authority citation revised.....................................51514 113 Authority citation revised.....................................51514 113.40 (b)(10)(ii) amended.........................................31722 114 Authority citation revised.....................................51514 123 Authority citation revised.....................................51514 129 Authority citation revised.....................................51514 130 Authority citation revised.....................................51514 131 Authority citation revised.....................................51514 131 Denial of request for hearing and confirmation of effective date........................................................8163 133 Authority citation revised.....................................51514 133 Denial of request for hearing and confirmation of effective date........................................................8163 135 Authority citation revised.....................................51514 136 Authority citation revised.....................................51514 137 Authority citation revised.....................................51514 139 Authority citation revised.....................................51514 145 Authority citation revised.....................................51514 146 Authority citation revised.....................................51514 150 Authority citation revised.....................................51514 152 Authority citation revised.....................................51514 155 Authority citation revised.....................................51514 156 Authority citation revised.....................................51514 158 Authority citation revised.....................................51514 160 Authority citation revised.....................................51514 161 Authority citation revised.....................................51514 163 Authority citation revised.....................................51514 164 Authority citation revised.....................................51514 165 Authority citation revised.....................................51514 165.110 (b)(5) reinstated; CFR correction...........................2266 165.110 (b)(4)(i)(A) table corrected; CFR correction...............36460 166 Authority citation revised.....................................51515 168 Authority citation revised.....................................51515 169 Authority citation revised.....................................51515 170 Technical correction...........................................47760 Authority citation revised.....................................51515 170.35 (c)(1)(viii) revised........................................40599 170.39 (c)(6) and (e) amended......................................40599 171 Technical correction...........................................47760 Authority citation revised.....................................51515 171.1 (c) amended..................................................40599 172 Authority citation revised.....................................51515 172.712 Added......................................................26228 172.841 (c) revised................................................30985 173 Authority citation revised.....................................51515 173.25 (a)(20) revised..............................................7679 Regulation at 62 FR 7679 eff. date corrected to 2-20-97.........8312 173.150 (a)(5) added...............................................59284 174 Authority citation revised.....................................51515 175 Authority citation revised.....................................51515 175.105 (c)(5) table amended..........................2013, 33996, 39937 175.300 (b)(3)(viii)(b)............................................43076 176 Authority citation revised.....................................51515 176.170 (a)(5) table amended................................10452, 39939 176.200 (d)(3) table amended.......................................39772 177 Authority citation revised.....................................51515 177.1345 (d) amended...............................................34628 177.1395 (b)(4) table amended......................................53957 177.1500 (c) redesignated as (d); new (c) added; new (d)(5)(ii) amended....................................................22886 177.1520 (b) table corrected; CFR correction................42050, 49908 178 Authority citation revised.....................................51515 178.2010 (b) table amended.......2013, 2015, 29009, 30456, 34629, 34630, 36983, 39441, 41272 178.3130 (b) table amended.........................................31511 178.3297 (e) table amended......................6723, 9366, 19221, 25477 178.3400 (c) table amended..................................33997, 42051 179 Authority citation revised.....................................51515 Effective date confirmation....................................64102 179.26 (b) table amended...........................................64121 180 Authority citation revised.....................................51515 181 Authority citation revised.....................................51515 182 Authority citation revised.....................................51515 184 Authority citation revised.....................................51515 184.1 (a) amended..................................................15110 184.1472 Revised...................................................30756 186 Authority citation revised.....................................51515 189 Authority citation revised.....................................51515 190 Added..........................................................49891 200 Authority citation revised.....................................51515 200.30--200.31 (Subpart B) Removed; eff. 4-14-97...................12084 201 Authority citation revised.....................................51515 [[Page 312]] 201.57 (f)(10) added; eff. 8-27-98.................................45325 201.64 (a) through (h) stayed; (i) revised.........................19925 202 Authority citation revised.....................................51515 205 Authority citation revised.....................................51515 206 Authority citation revised.....................................51515 207 Authority citation revised.....................................51515 210 Authority citation revised.....................................51516 211 Compliance date extension......................................40447 Authority citation revised.....................................51516 211.1 (d) added....................................................19497 (d) removed....................................................66522 225 Authority citation revised.....................................51516 226 Authority citation revised.....................................51516 250 Authority citation revised.....................................51516 250.10 Removed; eff. 4-14-97.......................................12084 250.103 Removed; eff. 4-14-97......................................12084 250.106 Removed; eff. 4-14-97......................................12084 290 Authority citation revised.....................................51516 291 Authority citation revised.....................................51516 299 Authority citation revised.....................................51516 300 Authority citation revised.....................................51516 310 Authority citation revised.....................................51516 310.305 (a) and (f)(1) revised; (b)(5) and (c)(4) removed; (c)(5) and (6) redesignated as (c)(4) and (5); new (c)(4) amended 34167 (a), (d)(2), (3) introductory text and (i) amended; (b), (c), (d)(1), (3)(ii) and (4) revised; eff. 4-6-98.......................52249 310.502 Revised; eff. 4-14-97......................................12084 310.504 Removed; eff. 4-14-97......................................12084 310.506 Removed; eff. 4-14-97......................................12084 310.507 Removed; eff. 4-14-97......................................12084 310.508 Removed; eff. 4-14-97......................................12084 310.509 Revised; eff. 4-14-97......................................12084 310.510 Removed; eff. 4-14-97......................................12085 310.513 Removed; eff. 4-14-97......................................12085 310.518 Added; eff. 7-15-97.........................................2250 (b)(2) and (c)(5) corrected; eff. 7-15-97......................15111 310.525 Removed; eff. 4-14-97......................................12085 310.526 Removed; eff. 4-14-97......................................12085 312 Meeting........................................................46198 Technical correction...........................................47760 Authority citation revised.....................................51516 312.20 (c) amended.................................................32479 312.23 (a)(7)(iv)(e) revised.......................................40599 312.32 (a), (b), (c)(1)(i), (2) and (d)(3) revised; (c)(3) and (e) amended; eff. 4-6-98.......................................52250 312.70 (a) and (b) amended.........................................46876 314 Meeting.................................................44891, 46198 Technical correction...........................................47760 Authority citation revised.....................................51516 Clarification..................................................63268 314.50 (d)(1)(iii) revised.........................................40599 314.70 (g) added...................................................39900 314.80 (c)(1)(ii) removed; (c)(1)(iii) and (iv) redesignated as (c)(1)(ii) and (iii); (a), new (c)(1)(ii) introductory text, (d)(1) and (l) amended; (f)(1) revised...............34168 (a), (c) introductory text, (1), (f)(1), (3)(ii) and (4) revised; (b), (c)(2)(ii)(b), (d)(2), (f) heading, (2) and (3) amended; (j) removed; (k) and (l) redesignated as (j) and (k); eff. 4-6-98........................................................52251 314.101 (d)(4) revised.............................................40599 314.110 (a)(3) and (b) amended.....................................43639 314.120 (a)(3) amended.............................................43639 314.440 (a)(3) amended.............................................43639 316 Authority citation revised.....................................51516 320 Authority citation revised.....................................51516 329 Authority citation revised.....................................51516 330 Authority citation revised.....................................51516 331 Authority citation revised.....................................51516 331.10 (a) correctly revised; CFR correction.......................52659 332 Authority citation revised.....................................51516 333 Authority citation revised.....................................51516 336 Authority citation revised.....................................51516 338 Authority citation revised.....................................51516 340 Authority citation revised.....................................51516 341 Authority citation revised.....................................51516 341.12 (h) correctly revised; CFR correction........................6866 341.76 (d)(2) heading correctly removed.............................9684 344 Authority citation revised.....................................51517 346 Authority citation revised.....................................51517 347 Authority citation revised.....................................51517 348 Authority citation revised.....................................51517 349 Authority citation revised.....................................51517 352 Announcement...................................................23350 355 Authority citation revised.....................................51517 357 Authority citation revised.....................................51517 358 Authority citation revised.....................................51517 361 Authority citation revised.....................................51517 369 Authority citation revised.....................................51517 429 Authority citation revised.....................................51517 430 Authority citation revised.....................................51517 431 Authority citation revised.....................................51517 432 Authority citation revised.....................................51517 433 Authority citation revised.....................................51517 436 Authority citation revised.....................................51517 436.215 (c)(16)(iv) and (18)(iv) corrected; CFR correction.........52659 [[Page 313]] 440 Authority citation revised.....................................51517 441 Authority citation revised.....................................51517 442 Authority citation revised.....................................51517 443 Authority citation revised.....................................51517 444 Authority citation revised.....................................51517 446 Authority citation revised.....................................51517 448 Authority citation revised.....................................51517 449 Authority citation revised.....................................51517 450 Authority citation revised.....................................51518 452 Authority citation revised.....................................51518 453 Authority citation revised.....................................51518 455 Authority citation revised.....................................51518 460 Authority citation revised.....................................51518 500 Authority citation revised.....................................51518 500.80 (b) amended.................................................66983 501 Authority citation revised.....................................51518 502 Authority citation revised.....................................51518 509 Authority citation revised.....................................51518 510 Technical correction...........................................23534 Authority citation revised.....................................51518 510.515 (c) table corrected; CFR correction........................52659 510.600 (c)(1) table and (2) table amended....6724, 22887, 27691, 29010, 34631, 35075, 38906, 39442, 40931, 48939, 55159, 60781, 61624, 61626, 62241, 63270 (c)(1) table and (2) table amended; eff. 4-7-97................14300 Regulation at 62 FR 14300 eff. date corrected to 4-7-97........15751 511 Technical correction...........................................47760 Authority citation revised.....................................51518 511.1 (b)(10) revised..............................................40599 514 Technical correction...........................................47760 Authority citation revised.....................................51518 514.1 (b)(14) revised..............................................40599 514.8 (a)(1) amended...............................................40600 514.110 (b)(10) revised............................................40600 514.111 (a)(9) revised.............................................40600 520 Technical correction............................................8370 Authority citation revised.....................................51518 520.23 (a)(2) amended..............................................35075 520.82a (b) amended................................................61624 520.82b (b) amended................................................61624 520.88b (c) amended................................................13302 520.88d (d) heading and (2) revised; (d)(3) amended.................5525 520.88e (d) heading and (2) revised; (d)(3) amended.................5526 520.88f (b) amended................................................13302 520.100a (b) amended...............................................63270 520.100b (b) amended...............................................63270 520.100c (b) amended...............................................63270 520.222 (c) amended................................................61624 520.300a (b) amended...............................................63270 520.300b (b) amended...............................................63270 520.300c (b) amended...............................................63270 520.390a (a)(2) amended............................................35076 520.420 (a)(2) amended.............................................63270 520.445b (b) amended.................................27691, 35076, 60656 520.447 (b) revised................................................46669 520.462 (b) amended................................................63270 520.580 (b)(2) amended......................................35076, 61624 520.600 (c) amended................................................35076 520.622a (a)(6) amended............................................35076 520.622b (c)(2) amended............................................35076 (a)(2) amended.................................................38906 520.622c (b)(6) amended............................................35076 (b)(6) corrected...............................................40932 (b)(5) amended.................................................61624 520.763a (c) amended...............................................35076 520.763b (c) amended...............................................35076 520.763c (b) amended...............................................35076 520.784 (b) amended................................................61624 520.804 (b) amended................................................63270 520.812 (c) redesignated as (d); new (d) revised...................38906 520.863 (b) amended................................................61624 520.1010a (b) amended........................................6724, 35076 520.1044a (b) amended..............................................34169 520.1044b (b) amended..............................................29011 520.1044c (b) amended..............................................29013 520.1120a (c) amended..............................................61624 520.1120b (c) amended..............................................61625 520.1192 (b) amended...............................................63270 520.1193 Heading and (a) revised; (d) added.........................5319 (b) amended....................................................63270 520.1194 (b) amended...............................................63270 520.1195 (b) amended...............................................63270 520.1196 (b) amended...............................................63270 520.1197 (b) amended...............................................63270 520.1242a (c)(2) amended...........................................61625 520.1242b (c) amended..............................................61625 520.1242g (e) amended..............................................55160 (c) amended....................................................61625 520.1263c (b) amended..............................................65020 520.1288 (c)(3) amended.............................................8371 (c) heading revised; (d) added.................................12085 (a), (d)(1) and (3) revised....................................14301 520.1289 (c)(3) amended.............................................8371 520.1320 (c) amended...............................................61625 520.1326a (b) amended..............................................61625 520.1326b (b) amended..............................................61625 520.1408 (b) amended...............................................35076 520.1446 Added.....................................................28629 520.1451 Added.....................................................37713 520.1452 Added.....................................................42902 520.1484 (b) and (c)(3) amended....................................55160 520.1485 (d)(3) amended............................................60657 520.1616 Added.....................................................29012 (d)(1) heading and (iii) amended...............................61627 [[Page 314]] 520.1660d (a)(8) and (b)(6) added..................................23356 (b)(3), (e)(1)(ii)(A)(3), (B)(3) and (C)(3) amended............35076 520.1696b (b) amended..............................................55160 520.1720a (b)(1) amended...........................................61625 520.1720b (b) amended..............................................61625 520.1720c (b) amended..............................................61625 520.1805 (b) amended...............................................61625 520.1900 (b) amended...............................................35076 520.2043 (b)(2) revised............................................37712 520.2080 Removed...................................................15111 520.2098 Added.....................................................34632 (d) heading and (2) corrected..................................55159 520.2170 (c) amended...............................................63270 520.2220a (b) amended.................................8371, 23357, 35076 (b) corrected..................................................40932 520.2220b (b)(3) amended...........................................61625 520.2220c (c) amended..............................................61625 520.2260b (f)(1) and (h)(1) amended................................35076 520.2325a (a)(4) added.............................................37712 520.2345d (a)(1) amended; (c) removed...............................5319 (a)(1), (d)(1)(iii) and (2)(iii) amended.......................35076 (a)(1) amended.................................................46668 (a)(1), (4), (d)(1)(iii) and (2)(iii) amended..................55160 520.2362 (c) amended...............................................61625 520.2380a (c)(2) amended...........................................63271 520.2380b (c) amended..............................................63271 520.2380c (c) amended..............................................63271 520.2380d (b) amended..............................................63271 520.2380f (b) amended..............................................63271 520.2455 (b) amended...............................................35076 520.2456 (b) amended...............................................35076 520.2481 (b) amended...............................................35076 520.2610 (b) amended...............................................61625 520.2611 (b) amended...............................................61625 520.2612 (b) amended...............................................61625 520.2640 (e)(1)(iii), (2)(iii) and (3)(iii) amended................39443 522 Authority citation revised.....................................51518 522.23 (c) amended.................................................35076 522.56 (b) amended.................................................23357 522.82 (b) amended.................................................61625 522.150 (b) amended................................................61625 522.518 (b) amended................................................28630 522.540 (a)(2) amended.............................................37713 522.770 (d)(2) revised.............................................44410 (d) heading revised; (d)(1), (2) and (3) redesignated as (d)(1)(i), (ii) and (iii); new (d)(1) heading and (2) added........62242 522.784 (b) amended................................................61625 522.812 (c) redesignated as (d); new (d)(2) revised................38907 522.863 (b) amended................................................61625 522.970 (b) revised................................................22888 522.1002 (b)(2) amended............................................62242 522.1010 (b) amended...............................................35076 522.1044 (b)(3) amended............................................35076 (b)(3) and (4) added...........................................45157 522.1150 (b) amended...............................................63271 522.1155 (b) amended...............................................61625 522.1156 Added.....................................................66984 522.1182 (b)(2)(i) amended.........................................35076 522.1183 (e)(1) amended............................................35076 522.1192 (d)(2)(ii) amended........................................14634 (b) amended....................................................63271 522.1193 (d)(2) amended............................................14302 (b) amended....................................................63271 522.1222a (c) amended.......................................22888, 35076 522.1244 (b) amended...............................................61625 522.1410 (b) amended...............................................35076 522.1452 (b) amended...............................................63271 522.1465 Added......................................................5320 522.1503 (b) amended...............................................61625 522.1660 (c)(1)(iii) corrected.....................................13825 (c) redesignated as (d); new (d)(1) heading revised; new (d)(1)(ii), new (iii) and new (2)(ii) amended......................27692 522.1662a (g)(3)(i)(c) revised.....................................14303 (a)(2), (g)(2) and (h)(2) amended..............................35076 522.1680 (b) amended........................................35076, 38906 522.1704 (a)(2) amended............................................61625 522.1720 (b)(2) amended............................................38906 (b)(1) amended.................................................61625 522.1850 (d) added.................................................45158 522.1885 (b) amended...............................................63271 522.1940 (d)(1)(iii) amended; (d)(2)(iv) removed....................8372 522.2005 (b) amended...............................................61625 522.2095 (d) revised...............................................10220 522.2220 (a)(2)(iii) added.........................................23128 (c)(2) amended.................................................35076 522.2424 (b) amended...............................................35076 522.2471 (d)(1)(ii) revised; (d)(1)(iii) amended....................5526 522.2476 (b) amended...............................................29013 522.2477 (a) revised...............................................28629 522.2483 (b) amended...............................................35077 522.2610 (b)(2) corrected; CFR correction..........................41272 (a)(2) amended.................................................61625 522.2615 (c) redesignated as (d); new (c) added; new (d)(3) revised.....................................................4164 522.2640a (b)(2) amended...........................................35077 522.2662 (b) amended...............................................35077 522.2680 (b) amended...............................................61625 [[Page 315]] 524 Authority citation revised.....................................51518 524.154 (a)(2) amended.............................................61625 524.155 (a)(1) amended.............................................61626 524.575 (c)(2) revised.............................................48940 524.770 Added......................................................65753 524.814 Added......................................................33997 524.900 (e) amended................................................55161 (c) amended....................................................61626 524.981a (b) amended...............................................40932 524.981b (b) amended...............................................40932 524.981c (b) amended...............................................40932 524.1044f (b) revised..............................................10220 524.1193 (d)(2) amended............................................38908 (b) amended....................................................63271 524.1240 (b) amended...............................................61626 524.1443 (b) revised...............................................55161 (b) amended....................................................61626 524.1484g (b) amended..............................................63271 524.1580b (b) amended..............................................35077 524.1580c (b) amended..............................................35077 524.1742 (b) amended...............................................61626 524.1883 (b) amended...............................................63271 526 Authority citation revised.....................................51518 529 Authority citation revised.....................................51518 529.50 (c)(2) amended..............................................15110 (b) amended....................................................23358 529.1044a (b) amended.........................................611, 35077 529.1044b (b) amended..............................................22889 529.1115 (b) amended...............................................29014 529.2090 (a)(1) amended.............................................8372 530 Authority citation revised.....................................51518 530.41 Revised.....................................................27947 556 Authority citation revised.....................................51518 556.52 Revised.....................................................40933 556.225 Revised....................................................62243 556.227 Added......................................................33998 556.273 Added......................................................55161 556.735 Corrected..................................................15391 556.738 Revised....................................................12086 556.741 Added.......................................................4164 558 Technical correction....................................23534, 44892 Authority citation revised.....................................51518 558.4 (d) table amended.....................................25477, 60657 558.55 (a) amended.................................................63271 558.58 (d)(1)(iii) table amended.....................60658, 61627, 66987 (d)(1) table amended...........................................63271 558.76 (d)(1)(iv) table amended....................................10304 (d)(1) table amended...........................................12952 558.78 (a) revised; (d)(1) table amended...........................55162 558.95 (b) redesignated as (d); (a)(5) and new (b) added; (d)(4)(i)(b) amended........................................8373 (d)(1)(ii)(b), (iii)(b), (iv)(b), (v)(b) and (3)(iii)(b) amended............................................................63271 558.120 (c) redesignated as (d); new (d)(1)(iii)(b) amended........61011 558.128 (c)(3)(xiii) added.........................................12086 (c)(3)(xiv) added..............................................12952 (c) redesignated as (d); new (d)(1)(vi), new (xii) and new (xvii) amended.....................................................14303 (a)(4) and (d)(1) table amended................................27692 (d)(1) table and (2) amended...................................61628 558.145 (a)(1) amended.............................................14300 558.155 (a)(1) and (2) amended.....................................35077 (a)(1) amended.................................................67725 558.175 (c)(1)(iii)(b) and (iv)(b) amended.........................61626 (c) redesignated as (d); new (d)(1)(iv)(b) amended.............61912 (d)(1)(iii)(b) amended.........................................62243 558.195 (c)(2) added; (d) table amended............................23129 (d) table amended................................61626, 66523, 67273 (a) and (d) table amended......................................67725 558.205 (a) amended................................................35077 558.235 (a) amended................................................63271 558.254 (c) amended................................................55161 (a) amended....................................................61626 558.274 (a)(4), (c)(1)(i) and (ii) amended; eff. 4-7-97............14301 Regulation at 62 FR 14301 eff. date corrected to 4-7-97........15751 (a)(7) and (c)(1) table amended................................27692 (a)(8), (c)(1)(i) table and (ii) table amended.................55160 558.300 (a)(1) and (2) amended.....................................63271 558.305 (b) redesignated as (d); new (b) and (c) added; new (d)(3) heading revised.............................................9929 558.311 (e)(3)(i) table amended....................................28630 (e)(1)(ii) table amended.......................................61626 558.342 (c)(5)(ii)(C) amended.......................................8373 (c) redesignated as (d); new (c) and (d)(7) added..............14304 558.355 (b)(7) and (14) amended....................................14304 (f)(3)(ii)(a), (ix)(a) and (x)(b) table amended................14306 (f)(1)(xv)(b) and (xvi)(b) amended.............................61912 558.366 (a) and (c) table amended..................................29011 558.485 (a)(4) removed; eff. 4-7-97................................14301 Regulation at 62 FR 14301 eff. date corrected to 4-7-97........15751 (a)(11) amended................................................27692 (a)(28) added..................................................46444 558.515 (d)(1)(vi)(b) amended...............................61626, 66986 [[Page 316]] 558.525 Removed....................................................15111 558.530 (a) amended................................................67725 558.550 (b)(3) redesignated as (b)(4); new (b)(3) added; eff. 5- 27-97......................................................14305 (b) redesignated as (d); (d)(1)(xvii) added....................29014 (b)(1)(vii)(c) amended.........................................60781 (b)(1)(ix)(c) amended..........................................66985 558.553 (b)(3) added...............................................66584 558.555 (b)(4) added...............................................66985 558.600 (c)(4) added...............................................12086 (a) amended....................................................35077 558.615 (a) amended................................................63271 558.618 (d)(1) corrected...........................................15391 558.625 (b)(53) removed; eff. 4-7-97...............................14301 (f)(1)(i)(b) amended...........................................14306 (f)(1)(vi)(e) correctly revised................................15111 Regulation at 62 FR 14301 eff. date corrected to 4-7-97........15751 (b)(10) and (52) amended.......................................27692 558.630 (b)(3) and (10) amended; eff. 4-7-97.......................14301 Regulation at 62 FR 14301 eff. date corrected to 4-7-97........15751 (b)(3), (8) and (10) amended...................................27692 564 Authority citation revised.....................................51518 570 Technical correction...........................................47760 Authority citation revised.....................................51518 570.35 (c)(1)(viii) revised........................................40600 571 Technical correction...........................................47760 Authority citation revised.....................................51518 571.1 (c) amended..................................................40600 573 Authority citation revised.....................................51518 573.920 Regulation at 60 FR 53703 confirmed........................44894 579 Denial of request for hearing....................................611 Authority citation revised.....................................51518 582 Authority citation revised.....................................51518 584 Authority citation revised.....................................51518 589 Authority citation revised..............................30976, 51519 589.2000 Added (OMB number pending)................................30976 600 Meeting........................................................44891 Authority citation revised.....................................51519 600.3 (ff) and (gg) added..........................................39901 600.10 (a) removed; (b) heading revised............................53538 600.80 (c)(1)(ii) removed; (c)(1)(iii) and (iv) redesignated as (c)(1)(ii) and (iii); (a), new (c)(1)(ii) introductory text, (d)(1) and (m) amended; (f)(1) revised...............34168 (a), (c)(1) and (f)(1) revised; (b) and (g) amended; (j) removed; (k), (l) and (m) redesignated as (j), (k) and (l); eff. 4-6-98.............................................................52252 601 Meeting.................................................44891, 46198 Technical correction...........................................47760 Authority citation revised.....................................51519 601.2 (c)(3) corrected.............................................11769 (a) and (c)(2) amended.........................................40600 (a) introductory text amended; (c)(6) added....................53538 601.12 Revised.....................................................39901 601.25 (b)(3) amended..............................................53538 606 Authority citation revised.....................................51519 606.20 (a) removed.................................................53538 607 Authority citation revised.....................................51519 610 Meeting........................................................44891 Authority citation revised.....................................51519 610.9 Revised......................................................39903 610.12 (f) revised.................................................48175 610.53 (c) table amended...........................................15110 640 Meeting........................................................44891 Authority citation revised.....................................51519 640.120 (a) revised................................................39903 660 Authority citation revised.....................................51519 680 Authority citation revised.....................................51519 700 Authority citation revised.....................................51519 701 Authority citation revised.....................................51519 710 Authority citation revised.....................................51519 720 Authority citation revised.....................................51519 730 Removed........................................................43074 Authority citation revised.....................................51519 740 Authority citation revised.....................................51519 800 Authority citation revised.....................................51519 801 Authority citation revised.....................................51519 801.435 Added......................................................50501 801.437 Added; eff. 9-30-98........................................51029 803 Authority citation revised.....................................51519 803.1 (a) revised; eff. 5-19-97....................................13306 803.57 Revised; eff. 5-19-97.......................................13306 804 Authority citation revised.....................................51519 804.30 Added; eff. 5-19-97.........................................13306 805 Authority citation revised.....................................51519 806 Added..........................................................27191 Authority citation revised.....................................51519 806.10 Regulation at 62 FR 27191 stayed............................67274 806.20 Regulation at 62 FR 27191 stayed............................67274 807 Authority citation revised.....................................51519 [[Page 317]] 808 Authority citation revised.....................................51519 808.51 Added.......................................................63274 808.52 Added.......................................................63274 808.94 Added.......................................................63274 809 Authority citation revised.....................................51520 809.10 (a) amended; (e) added; eff. 11-23-98.......................62259 809.30 Added; eff. 11-23-98........................................62259 810 Authority citation revised.....................................51520 812 Authority citation revised..............................26229, 51520 Meeting........................................................46198 Technical correction...........................................47760 812.2 (c)(8) removed................................................4165 (c) introductory text revised; eff. 5-13-97....................12096 812.18 (b) revised.................................................26229 812.20 (b)(9) revised..............................................40600 812.36 Added.......................................................48947 812.119 Added; eff. 5-13-97........................................12096 812.150 (b)(5) revised.............................................48948 813 Removed.........................................................4165 814 Meeting........................................................46198 Technical correction...........................................47760 Authority citation revised.....................................51520 814.20 (b)(11) revised.............................................40600 814.102 Reinstated.................................................38026 814.104 Reinstated.................................................38026 814.106 Reinstated.................................................38026 814.108 Reinstated.................................................38026 814.110 (a) reinstated.............................................38026 814.112 (b) reinstated.............................................38026 814.116 (b) reinstated.............................................38026 814.118 (d) reinstated.............................................38026 814.120 (b) reinstated.............................................38026 814.124 (b) reinstated.............................................38026 814.126 (b)(1) reinstated..........................................38026 820 Authority citation revised.....................................51520 821 Authority citation revised.....................................51520 860 Authority citation revised.....................................51520 861 Authority citation revised.....................................51520 862 Authority citation revised.....................................51520 864 Authority citation revised.....................................51520 864.4010 (a) revised; eff. 11-23-98................................62260 864.4020 Added; eff. 11-23-98......................................62260 866 Authority citation revised.....................................51520 866.6010 Revised...................................................66005 868 Authority citation revised.....................................51520 870 Authority citation revised.....................................51520 872 Authority citation revised.....................................51520 872.6730 (c) revised................................................2902 (c) amended....................................................31512 874 Authority citation revised.....................................51520 876 Authority citation revised.....................................51520 878 Authority citation revised.....................................51520 880 Authority citation revised.....................................51520 880.5130 Revised...................................................33350 882 Authority citation revised.....................................51520 882.5800 (c) revised...............................................30457 884 Authority citation revised.....................................51520 886 Authority citation revised.....................................51520 886.5918 Revised...................................................30987 886.5928 Revised...................................................30988 886.5933 Removed...................................................30988 888 Authority citation revised.....................................51520 890 Authority citation revised.....................................51520 892 Authority citation revised.....................................51520 895 Authority citation revised.....................................51520 897 Authority citation revised.....................................51520 898 Added..........................................................25497 Authority citation revised.....................................51521 898.14 Stayed......................................................25498 900 Authority citation revised.....................................51521 Revised; eff. in part 4-28-99..................................55976 (c)(4) corrected...............................................60614 900.12 (b)(8)(i), (e)(4)(iii)(B) and (5)(i)(B) revised; eff. 10- 28-02......................................................55984 (a)(2)(iv), (b)(6)(ii), (8)(i), (e)(1)(ii), (iii), (2)(ii), (4)(iii)(B), (5)(i)(B), (ii), (iii), (x)(A), (12) and (h) heading corrected; effective date corrected in part........................60614 900.18 (a)(1) corrected............................................60614 1000 Authority citation revised....................................51521 1002 Authority citation revised....................................51521 1003 Authority citation revised....................................51521 1004 Authority citation revised....................................51521 1005 Authority citation revised....................................51521 1010 Authority citation revised....................................51521 1020 Authority citation revised....................................51521 1030 Authority citation revised....................................51521 1040 Authority citation revised....................................51521 1050 Authority citation revised....................................51521 1210 Authority citation revised....................................51521 1220 Authority citation revised....................................51521 1230 Authority citation revised....................................51521 [[Page 318]] 1240 Authority citation revised....................................51521 1250 Authority citation revised....................................51521 1270 Revised.......................................................40444 Authority citation revised.....................................51521 Chapter II 1300 Added.........................................................13941 1300.02 (b)(28)(i)(D)(1), (2) and (29) correctly revised...........15392 1301.01 Revised....................................................13945 1301.02 Revised....................................................13945 1301.11--1301.18 Undesignated center heading revised...............13945 1301.11 Revised....................................................13945 1301.12 Revised....................................................13945 1301.13 Revised....................................................13946 1301.14 Added......................................................13948 1301.15 Added......................................................13948 1301.16 Added......................................................13949 1301.17 Added......................................................13949 1301.18 Added......................................................13949 1301.21--1301.26 Undesignated center heading revised...............13950 1301.21 Revised....................................................13950 1301.22 Revised....................................................13950 1301.23 Revised....................................................13951 1301.24 Revised....................................................13951 1301.25 Revised....................................................13951 1301.26 Revised....................................................13952 1301.31--1301.37 Undesignated center heading revised...............13953 1301.31 Revised....................................................13953 1301.32 Revised....................................................13953 1301.33 Revised....................................................13953 1301.34 Revised....................................................13953 1301.35 Revised....................................................13954 1301.36 Revised....................................................13955 1301.37 Revised....................................................13955 1301.41--1301.46 Undesignated center heading revised...............13956 1301.41 Revised....................................................13956 1301.42 Revised....................................................13956 1301.43 Revised....................................................13956 1301.44 Revised....................................................13956 1301.45 Revised....................................................13956 1301.46 Revised....................................................13956 1301.51--1301.52 Undesignated center heading revised...............13956 1301.51 Revised....................................................13956 1301.52 Revised....................................................13957 1301.53 Removed....................................................13945 1301.54 Removed....................................................13945 1301.55 Removed....................................................13945 1301.56 Removed....................................................13945 1301.57 Removed....................................................13945 1301.61--1301.63 Undesignated center heading removed...............13945 1301.61 Removed....................................................13945 1301.62 Removed....................................................13945 1301.63 Removed....................................................13945 1301.72 (b)(4)(i)(b) amended.......................................13957 1301.75 (b) revised................................................13957 1301.76 (c) revised................................................13957 1302.02 Revised....................................................13958 1302.04 Revised....................................................13958 1302.05 Removed; new 1302.05 redesignated from 1302.06 and revised 13958 1302.06 Redesignated as 1302.05; new 1302.06 redesignated from 1302.07 and revised........................................13958 1302.07 Redesignated as 1302.06; new 1302.07 redesignated from 1302.08 and revised........................................13958 1302.08 Redesignated as 1302.07....................................13958 1303.02 Revised....................................................13958 1303.12 (b), (d), (e)(1) and (3) amended...........................13958 1303.21 (a) amended................................................13958 1303.22 Introductory text amended..................................13958 1303.26 Amended....................................................13958 1303.27 Amended....................................................13958 1303.32 (b) amended................................................13958 1303.35 (a) amended................................................13958 1304 Authority citation revised....................................13958 1304.02 Revised....................................................13958 1304.03 (f) revised; (g) and (h) removed...........................13958 1304.04 (a) introductory text amended; (e) and (h) revised.........13959 1304.11 Revised....................................................13959 1304.12 Removed....................................................13960 1304.13 Removed....................................................13960 1304.14 Removed....................................................13960 1304.15 Removed....................................................13960 1304.16 Removed....................................................13960 1304.17 Removed....................................................13960 1304.18 Removed....................................................13960 1304.19 Removed....................................................13960 1304.21 (a) and (c) revised........................................13960 1304.22 Revised....................................................13960 1304.23 Removed; new 1304.23 redesignated from 1304.27.............13961 1304.24 Removed; new 1304.24 redesignated from 1304.28; (b) and (d) amended................................................13961 1304.25 Removed; new 1304.25 redesignated from 1304.29.............13961 1304.26 Removed....................................................13961 [[Page 319]] 1304.27 Redesignated as 1304.23....................................13961 1304.28 Redesignated as 1304.24....................................13961 1304.29 Redesignated as 1304.25....................................13961 1304.31 Revised....................................................13961 1304.32 Revised....................................................13962 1304.33 Removed; new 1304.33 redesignated from 1304.34 and revised (OMB number)...............................................13962 1304.34 Redesignated as 1304.33....................................13962 1304.35 Removed....................................................13963 1304.36 Removed....................................................13963 1304.37 Removed....................................................13963 1304.38 Removed....................................................13963 1305.02 Revised....................................................13963 1305.03 Revised....................................................13963 1305.04 (b) amended................................................13964 1305.05 (b) amended................................................13964 1305.06 Revised....................................................13963 1305.07 Revised....................................................13963 1305.08 (a) amended................................................13964 1305.09 (b) and (d) amended........................................13964 1305.10 (a) amended................................................13964 1305.12 (b) revised................................................13964 1305.13 (a), (b), and (c) amended..................................13964 1305.14 Amended....................................................13964 1305.16 (b) amended................................................13964 1306.02 Revised....................................................13964 1306.03 (a)(2) amended.............................................13966 1306.05 (b) and (c) amended........................................13966 1306.11 (a), (d)(4) and (e) revised; (g) added.....................13964 1306.13 (b) revised................................................13965 1306.14 Heading revised; (c) added.................................13965 1306.15 Removed....................................................13965 1306.21--1306.26 Undesignated center heading revised...............13965 1306.21 Revised....................................................13965 1306.22 (a)(2), (b) introductory text, (2) and (4) amended.........13966 1306.23 Introductory text revised..................................13965 1306.24 Revised....................................................13965 1306.25 Removed....................................................13965 Redesignated from 1306.26; (a) and (b) revised.................13966 1306.26 Redesignated as 1306.25; new 1306.26 redesignated from 1306.32; introductory text and (a) revised.................13966 1306.31--1306.32 Undesignated center heading removed...............13966 1306.31 Removed....................................................13966 1306.32 Redesignated as 1306.26....................................13966 1307.01 Revised....................................................13966 1307.02 Revised....................................................13966 1307.03 Revised....................................................13966 1307.11 (a)(2), (4) and (b) amended................................13967 1307.12 Removed....................................................13966 Redesignated from 1307.13......................................13967 1307.13 Redesignated as 1307.12; new 1307.13 redesignated from 1307.15....................................................13967 1307.14 Removed....................................................13967 1307.15 Redesignated as 1307.13....................................13967 1307.21 (a) revised................................................13967 1307.22 Amended....................................................13967 1308 Controlled substance schedules...........29288, 29289, 51774, 51776 1308.02 Revised....................................................13967 1308.03 (a) amended................................................13968 1308.04 Removed....................................................13967 1308.12 (g) amended................................................13968 1308.13 (b)(1) amended.............................................13968 1308.14 (f)(2) added...............................................51371 1308.22 Table amended..............................................13968 1308.23 (c)(7) and (f) amended.....................................13968 1308.24 Table removed; (a) and (i) revised.........................13967 (d) amended....................................................13968 1308.26 Table removed; (a) revised.................................13967 1308.32 Table removed..............................................13967 1308.33 (a) and (b) amended........................................13968 1308.34 Table removed..............................................13967 1308.42 Revised....................................................13968 1308.43 Removed; new 1308.43 redesignated from 1308.44; (f) amended....................................................13968 1308.44 Redesignated as 1308.43; new 1308.44 redesignated from 1308.45; (e) amended.......................................13968 1308.45 Redesignated as 1308.44; new 1308.45 redesignated from 1308.48....................................................13968 1308.46 Removed; new 1308.46 redesignated from 1308.49; corrected 13968 1308.47 Removed; new 1308.47 redesignated from 1308.50.............13968 1308.48 Redesignated as 1308.45....................................13968 1308.49 Redesignated as 1308.45; new 1308.49 redesignated from 1308.52; amended...........................................13968 1308.50 Redesignated as 1308.45....................................13968 1308.51 Removed....................................................13968 1308.52 Redesignated as 1309.49....................................13968 1309 Waiver........................................................53958 1309.02 Revised....................................................13968 1309.21 (a) and (b) amended........................................13968 [[Page 320]] 1309.25 (a) and (b) amended........................................13968 1309.29 Added; interim..............................................5916 Regulation at 62 FR 5916 confirmed.............................52256 Revised........................................................53960 1309.43 (d) revised; (e) added; interim.............................5916 Regulation at 62 FR 5916 confirmed.............................52256 1309.44 (b) revised; interim........................................5916 Regulation at 62 FR 5916 confirmed.............................52256 1309.53 Removed; new 1309.53 redesignated from 1309.54.............13968 1309.54 Redesignated as 1309.53; new 1309.54 redesignated from 1309.55....................................................13968 1309.55 Redesignated as 1309.54; new 1309.55 redesignated from 1309.56....................................................13968 1309.56 Redesignated as 1309.55....................................13968 1309.57 Removed....................................................13968 1309.62 Existing text designated as (a); new (a) revised; (b) added; interim..............................................5916 Regulation at 62 FR 5916 confirmed.............................52256 1309.71 (a)(2) amended.............................................13968 1310.01 (f)(1)(iv)(A) and (B) revised; (g) through (k) and (l) redesignated as (h) through (l) and (o); new (g) and (n) added; interim..............................................5916 Revised........................................................13968 Regulation at 62 FR 5917 confirmed.............................52256 1310.02 (a)(16) and (21) revised; interim...........................5917 Regulation at 62 FR 5917 confirmed.............................52256 1310.04 (a) revised; interim........................................5917 Regulation at 62 FR 5917 confirmed.............................52256 1310.05 (c) amended................................................13968 1310.08 Introductory text amended..................................13968 1310.09 Revised; interim............................................5917 Removed........................................................13968 Reinstated.....................................................15392 Revised; interim...............................................27693 Regulation at 62 FR 27693 confirmed............................52256 Existing text designated as (a); (b) added.....................53960 1310.10 (a) amended................................................13968 1310.14 (a) amended................................................13968 1310.15 (d) amended................................................13968 1311 Removed.......................................................13969 1311.27 (b)(2) revised; (c) added...................................4645 1312.02 Revised....................................................13969 1312.12 (a) amended................................................13969 1312.14 (a) amended................................................13969 1312.16 (b) amended................................................13969 1312.17 Amended....................................................13969 1312.18 (b) and (c) amended........................................13969 1312.19 (a) and (b) amended........................................13969 1312.22 (a) amended................................................13969 1312.24 (a) amended................................................13969 1312.25 Amended....................................................13969 1312.27 (a), (b)(5)(iii) and (iv) amended..........................13969 1312.28 (d) amended................................................13969 1312.31 (b) amended................................................13969 1312.32 (a) amended................................................13969 1313.02 (d)(1)(iv)(A) and (B) revised; interim......................5917 Revised........................................................13969 Regulation at 62 FR 5917 confirmed.............................52256 1313.15 (a) amended................................................13969 1313.21 (c)(1) amended.............................................13969 1313.24 (a) amended................................................13969 1316.02 (g) revised................................................13969 1316.05 Amended....................................................13970 1316.12 Amended....................................................13970 1316.13 Revised....................................................13969 1316.23 (b) amended................................................13970 1316.24 (c) amended................................................13970 1316.41 Amended....................................................13970 1316.42 (h) revised................................................13969 1316.46 (b)(1) amended.............................................13970 1316.52 (a) amended................................................13970 1316.71 (f) revised................................................13969 1316.77 (a) amended................................................13970 1316.81 Amended....................................................13970 Chapter III 1403.26 (a), (b) introductory text and (1) revised..........45939, 45941 1998 21 CFR 63 FR Page Chapter I 2.10 (b)(2) revised................................................51299 3 Authority citation revised.......................................26697 5 Effective date confirmation......................................48576 5.20 (h) revised...................................................41960 5.31 (f)(2)(iii) and (iv) removed..................................26697 5.33 (c) reinstated; CFR correction................................51299 5.53 (a)(1) and (b)(1)(i) revised..................................27207 [[Page 321]] 5.73 Removed.......................................................26697 5.74 Removed.......................................................26697 5.83 Heading, (c)(1), (2) and (d) revised..........................70650 5.84 Heading, (a)(1) and (3) revised...............................70650 5.200 Revised......................................................18314 5.210 Revised......................................................18317 5.215 Revised......................................................18317 10 Authority citation revised......................................32735 Effective date confirmation....................................48576 10.50 (c)(10) removed..............................................26697 10.75 (b) amended..................................................32735 Regulation at 63 FR 32735 withdrawn............................50757 (b) redesignated as (b)(1); new (b)(2) added...................63982 14.100 (c)(18) added...............................................11597 16 Effective date confirmation.....................................48576 Authority citation revised.....................................64581 16.1 (b)(2) amended................................................26697 (b)(2) amended; interim........................................64581 25 Effective date confirmation.....................................48576 25.31 (f) amended..................................................26697 26 Added...........................................................60141 50 Authority citation revised......................................26697 Effective date confirmation....................................48576 50.1 (a) amended...................................................26697 54 Added; eff. 2-2-99...............................................5250 Effective date confirmation....................................48576 54.2 (d) and (e) revised...........................................72181 54.4 (a) corrected.................................................35134 56 Authority citation revised......................................26698 58 Authority citation revised......................................26698 71 Authority citation revised......................................26698 73 Technical correction............................................51299 73.75 (c)(1)(i) amended; (c)(3) added; (d) revised; eff. 4-28-98 14817 Regulation at 63 FR 14817 confirmed............................51299 74.3602 (b)(2)(v) added............................................20098 Regulation at 63 FR 20098 confirmed............................45943 99 Added...........................................................64581 101 Nomenclature change............................................14035 Technical correction...........................................17327 Food labeling prohibitions........34084, 34092, 34097, 34101, 34104, 34107, 34110, 34112, 34115 Comment periods reopened.......................................48428 Workshop.......................................................57594 Uniform compliance date establishment..........................71015 101.2 (c)(1)(ii)(B)(3)(i) removed; (c)(1)(ii)(B)(3)(ii), (c)(1)(ii)(B)(3)(iii) and (c)(1)(ii)(B)(3)(iv) redesignated as (c)(1)(ii)(B)(3)(i), (c)(1)(ii)(B)(3)(ii) and (c)(1)(ii)(B)(3)(iii)..................................14818 101.12 (e)(2) amended..............................................14818 101.13 (q)(8) amended..............................................14818 (g) introductory text and (h) introductory text removed; (g)(1), (2) and (3) redesignated as (h)(4)(i), (ii) and (iii); (h)(1) and new (4)(i), (ii) and (iii) revised; (j)(2)(ii), (p)(2), (q)(2), (3)(ii) introductory text, (5)(i) and (6) amended..........26980 101.14 (e)(3) amended..............................................26980 101.17 (f) added....................................................8118 (g) added......................................................37055 (g)(7)(i)(B) corrected.........................................63982 101.22 (i)(4) amended..............................................14818 101.36 (b)(3)(ii)(B), (C) and (iii) revised........................30620 101.54 (d)(2) revised..............................................26980 101.62 (d)(1)(ii)(D), (2)(iii)(C), (iv)(C), (4)(ii)(C) and (5)(ii)(C) amended.........................................26980 101.65 (d)(2)(iv) revised..........................................14355 101.69 (c), (d), (l), (m)(4) introductory text, (ii), (n)(3), (4), (o)(3), (4) introductory text and (ii) amended; (m)(3) revised; (m)(4)(iii) and (5) added.........................26718 (m)(3) and (4)(iii) corrected..................................40024 101.70 (j)(2) and (4)(ii) revised; (j)(3)(iii) added...............26719 (j)(3)(iii) corrected..........................................40024 101.81 Heading, (a) heading, (3), (b) heading, (b)(2), (c)(1), (2)(i) introductory text, (A), (E), (F), (iii)(A), (d)(2), (3) and (e) revised; (c)(2)(i)(G) and (ii)(B) added; (d)(6) removed; (d)(7) and (8) redesignated as (d)(6) and (7).........................................................8119 102 Nomenclature change............................................14035 104 Authority citation revised.....................................11597 104.5 (e) amended..................................................14818 106 Nomenclature change............................................14035 114 Nomenclature change............................................14035 130 Nomenclature change............................................14035 131 Nomenclature change............................................14035 133 Nomenclature change............................................14035 135 Nomenclature change............................................14035 135.110 (f)(3)(i) amended..........................................14818 [[Page 322]] 136 Nomenclature change............................................14035 137 Nomenclature change............................................14035 139 Nomenclature change............................................14035 145 Nomenclature change............................................14035 146 Nomenclature change............................................14035 150 Nomenclature change............................................14035 155 Nomenclature change............................................14035 156 Nomenclature change............................................14035 160 Nomenclature change............................................14035 161 Nomenclature change............................................14035 163 Nomenclature change............................................14035 164 Nomenclature change............................................14035 165.110 (b)(4)(iii)(A) table and (C) table amended; (b)(4)(iii)(G)(3)(iv) note removed.........................25769 Regulation at 63 FR 25769 eff. date corrected to 2-2-99........30621 Effective date confirmation....................................42198 166 Nomenclature change............................................14035 168 Nomenclature change............................................14035 169 Nomenclature change............................................14035 172.155 (c)(1) revised.............................................66015 172.800 Regulation at 60 FR 21702 eff. date confirmed; (c)(13) added......................................................36362 172.824 (b)(3) removed..............................................7069 172.831 Added......................................................16433 172.841 (a)(2) and (b) revised.....................................57597 172.878 (c) table amended..........................................66014 173.300 (b) revised................................................38747 173.315 Heading and (c) revised; (a)(3) redesignated as (a)(4); new (a)(3) added; introductory text, (a)(2) table and new (4) amended.................................................7069 173.325 (b) revised; (c) and (d) added.............................11119 173.340 (a)(4) introductory text revised; (a)(4) table amended.....29134 175.105 (c)(5) table amended.........................37248, 51527, 56788 175.125 (a)(7) added; (b)(1) revised................................3464 (a)(8) added; (b)(1) revised...................................51528 175.300 (b)(3)(vii)(a) amended.....................................59707 (b)(3)(xxviii)(a)..............................................71017 175.320 (b)(3) table amended.......................................71017 176.170 (b)(2) table amended.......................................69551 176.180 (b)(2) table amended................................59709, 63408 177.1390 (c)(2)(vii) added; (c)(3)(i)(a)(1) revised................55943 177.1430 (b) table amended.........................................36175 177.1500 (b) table amended..........................................6854 177.1520 (a)(1) redesignated as (a)(1)(i); (a)(1)(ii) added; (c) amended.....................................................6853 177.2415 Added.....................................................20315 177.2460 (c)(1) amended.............................................8852 177.2600 (c)(4)(i) amended..........................................8572 178.2010 (b) table amended..........................................8853 (b) table amended...27836, 29136, 35135, 36177, 36178, 43875, 45716, 55945 (b) table corrected; CFR correction............................49285 178.3130 (b) table amended.........................................38748 178.3295 Table amended......................................56789, 68392 178.3297 (e) table amended..........................................3464 (e) table amended.........................43874, 55946, 59215, 59710 178.3400 (c) table amended.........................................29551 178.3725 Table amended.............................................35799 179 Technical correction...........................................46388 179.26 (c)(1) amended..............................................43876 184.1420 Added.....................................................24419 184.1444 (a) amended; (b)(3) added.................................14611 184.1702 Added.....................................................28895 200 Authority citation revised.....................................26698 200.15 Revised.....................................................26698 Regulation at 63 FR 26698 eff. date confirmed..................48576 201 Authority citation revised.....................................26698 Regulation at 63 FR 26698 eff. date confirmed..................48576 Stay of compliance.............................................67399 201.23 Added.......................................................66668 201.50 (b) amended.................................................26698 Regulation at 63 FR 26698 eff. date confirmed..................48576 201.57 (f)(2) revised; eff. 6-1-99.................................66396 201.100 (c)(2) amended.............................................26698 Regulation at 63 FR 26698 eff. date confirmed..................48576 201.307 Added......................................................27843 201.322 Added; eff. 4-23-99........................................56801 207 Authority citation revised.....................................26698 Regulation at 63 FR 26698 eff. date confirmed..................48576 207.25 (b)(2), (4), (5) and (6) amended............................26698 Regulation at 63 FR 26698 eff. date confirmed..................48576 207.31 (a)(1), (2), (3) and (c) amended............................26698 Regulation at 63 FR 26698 eff. date confirmed..................48576 207.37 (a)(2)(i) amended...........................................26698 Regulation at 63 FR 26698 eff. date confirmed..................48576 [[Page 323]] 208 Added; eff. 6-1-99.............................................66396 210 Authority citation revised.....................................26698 211 Authority citation revised.....................................26698 211.84 (c)(5) amended..............................................14356 211.132 Heading revised; (a), (d) introductory text and (2) amended; (b) and (c) revised...............................59470 310 Authority citation revised.....................................26698 310.545 (a)(27), (28) and (d)(28) added; (d) introductory text revised....................................................19802 (a)(6)(ii)(B) amended; eff. 7-30-99............................40649 (a)(23) and (24) redesignated as (a)(23)(i) and (24)(i); (a)(23)(i) heading, (ii), (24)(i) heading, (ii) and (d)(26) added; (d)(11) revised....................................................44998 310.547 Added; eff. 4-20-98........................................13528 312 Authority citation revised..............................26698, 68678 312.23 (a)(10)(iii) redesignated as (a)(10)(iv); new (a)(10)(iii) added......................................................66669 312.33 (a)(2) revised; eff. 8-10-98.................................6862 312.42 (e) revised; eff. 4-28-99...................................68678 312.47 (b)(1)(i) and (2) heading revised; (b)(1)(iv), (v) and (2) introductory text amended; (b)(2)(iii) redesignated as (b)(2)(iv); new (b)(2)(iii) added..........................66669 312.53 (c)(4) added; eff. 2-2-99....................................5252 312.57 (b) and (c) redesignated as (c) and (d); new (b) added; eff. 2-2-99.................................................5252 312.64 (d) added; eff. 2-2-99.......................................5252 312.82 (a) and (b) amended.........................................66669 312.80--312.88 (Subpart E) Authority citation revised..............26698 314 Authority citation revised..............................26698, 59712 Effective date confirmation....................................48576 314.50 (k) redesignated as (l); new (k) added; eff. 2-2-99..........5252 (d)(5)(v) and (vi)(a) amended; eff. 8-10-98.....................6862 Introductory text, (d)(5)(vi)(b) and (l)(1) amended; (c)(2)(i) and (e)(2)(ii) revised; eff. 6-1-99................................66398 (d)(7) added...................................................66670 314.55 Added.......................................................66670 314.60 (a) amended; eff. 2-2-99.....................................5252 314.70 (b)(3) revised; eff. 6-1-99.................................66399 314.80 (k) corrected...............................................14611 314.81 (b)(2)(i) and (vii) revised; (b)(2)(vi)(c) added............66670 314.94 (a)(13) added; eff. 2-2-99...................................5252 (a)(8) revised; eff. 6-1-99........................................66399 314.107 (c)(1) and (4) amended; interim............................59712 314.170 Amended....................................................26698 314.200 (d)(3) amended; eff. 2-2-99.................................5252 314.300 (b)(6) introductory text amended; eff. 2-2-99...............5252 314.430 (f)(6) amended.............................................26698 320.36 Existing text designated as (a); (b) added; eff. 2-2-99......5252 330.10 (f) added; eff. 2-2-99.......................................5253 341.20 (b)(1) revised; eff. 7-30-99................................40650 341.80 (c)(2)(ii), (vii), (d)(2)(i) and (viii) heading revised; eff. 7-30-99...............................................40650 343 Added; eff. 10-25-99...........................................56814 343.80 (a)(1) corrected; eff. 10-25-99.............................66015 (a)(2) corrected; eff. 10-25-99................................66016 358 Technical correction...........................................46389 358.610 Revised....................................................43303 369 Authority citation revised.....................................26698 Effective date confirmation....................................48576 369.5 Removed......................................................26698 369.21 Amended.....................................................26698 429 Removed........................................................26698 Effective date confirmation....................................48576 430 Removed........................................................26068 Effective date confirmation....................................48576 431 Removed........................................................26068 Effective date confirmation....................................48576 432 Removed........................................................26068 Effective date confirmation....................................48576 433 Removed........................................................26068 Effective date confirmation....................................48576 436 Removed........................................................26068 Effective date confirmation....................................48576 440 Removed........................................................26068 Effective date confirmation....................................48576 441 Removed........................................................26068 Effective date confirmation....................................48576 442 Removed........................................................26068 Effective date confirmation....................................48576 443 Removed........................................................26068 Effective date confirmation....................................48576 444 Removed........................................................26068 Effective date confirmation....................................48576 446 Removed........................................................26068 Effective date confirmation....................................48576 448 Removed........................................................26068 Effective date confirmation....................................48576 449 Removed........................................................26068 [[Page 324]] Effective date confirmation....................................48576 450 Removed........................................................26068 Effective date confirmation....................................48576 452 Removed........................................................26069 Effective date confirmation....................................48576 453 Removed........................................................26069 Effective date confirmation....................................48576 455 Removed........................................................26069 Effective date confirmation....................................48576 460 Removed........................................................26069 Effective date confirmation....................................48576 510 Technical correction.............................................408 510.105 (c)(2) revised.............................................32980 510.106 Revised....................................................32980 510.600 (c)(1) table and (2) table amended.......5254, 7700, 8122, 8347, 8349, 11598, 14612, 24106, 25164, 26981, 29551, 31624, 31931, 36178, 41188, 44381, 44383, 51822, 59216, 65553 514.111 (a)(5) revised; eff. 4-6-98................................10770 514.117 Added; eff. 4-6-98.........................................10770 520 Technical correction......................................408, 46652 520.88g (c)(1)(ii) amended.........................................13121 520.88h (c)(1)(ii) amended.........................................13121 520.154a (a) amended; (d)(4) added.................................38474 520.390b (b)(1) amended.............................................5255 520.452 Added......................................................41419 520.580 (b)(1) amended.............................................26981 520.645 Added.......................................................8123 520.870 Added......................................................51300 520.905a (a) removed; (b), (c) and (d)(3) redesignated as (a), (b) and (d)(4); (d)(2) heading revised; (d)(2)(i)(A), (B), (ii) introductory text, (A) and (B) redesignated as (d)(2)(ii), (iii), (3)(i), (ii) and (iii); new (c) and new (d)(3) heading added.......................................63983 520.905c (d)(1)(iii) added.........................................31624 520.1195 (b) amended...............................................38474 520.1242a (a) and (d) removed; (b), (c), (e) and (f) redesignated as (a) through (d); new (a), (b), (c), (d)(1)(i), (iii) and (2)(i) revised; new (d)(2)(iii) added..................59713 520.1288 Revised...................................................52968 520.1445 (a) and (c) heading revised; (d) added....................29352 (c) removed; (d) revised.......................................41189 520.1446 (c) redesignated as (d); new (d) revised..................41190 520.1448b Removed...................................................6862 520.1484 (b) revised; (c)(3) amended...............................17329 520.1485 (d)(3) amended............................................45944 520.1660c Heading, (a) and (b) revised; (c) removed; (d) and (e) redesignated as (c) and (d); new (d)(3) amended............70334 520.1660d (a)(3) revised...........................................44384 520.1720a (b)(3) amended...........................................36178 520.1806 (b) amended................................................8348 520.1880 (a) amended.................................................148 520.2043 (a)(2) revised............................................39727 (b)(2) amended.................................................45945 520.2098 (b) amended...............................................29551 520.2158a (b) amended..............................................51821 520.2220a (a) revised; (b) removed; (c), (d) and (e) redesignated as (b), (c) and (d)........................................59714 520.2345a (b)(4) removed............................................5255 522 Technical correction...........................................46652 522.84 Added.......................................................44382 522.90b (b) revised................................................41420 522.246 (b) revised................................................66432 522.314 (d)(2) added...............................................53578 522.468 Added......................................................13123 522.533 Added......................................................44383 522.535 Added......................................................13122 522.770 (d)(1)(ii) revised.........................................68183 522.778 Added.......................................................8349 522.812 (a) revised; (d)(1), (2) and (3) redesignated as (d)(1)(i), (ii) and (iii); (c), new (d)(1) heading and new (2) added..................................................49003 522.955 (d)(1)(iii) amended........................................26981 (d)(1)(i) revised; (d)(1)(iii) amended.........................41191 522.970 (c) redesignated as (d); new (c) added; (b) and new (d) revised....................................................38749 522.1044 (b)(3) amended............................................59714 (b)(4) revised.................................................68182 522.1081 (a)(2)(ii) amended........................................51822 522.1086 (b) amended; (c) redesignated as (d)......................29352 522.1125 Added.....................................................11598 522.1145 (a)(2) revised; (f) added.................................59216 522.1182 (b)(2)(i) amended.........................................53578 522.1183 (b) removed; (e)(1) amended...............................44384 522.1192 (a)(2) heading revised; (d)(6) added.......................7702 522.1222a (c) amended.......................................51822, 65553 522.1289 Added.....................................................29552 522.1462 (b) amended................................................7701 522.1642 (b) amended................................................7701 522.1660 (c) added; (d)(1) heading revised; (d)(1)(iii) amended....52157 522.1662a (h)(2) amended............................................6644 522.1940 (d)(3) added..............................................45945 [[Page 325]] 522.2005 (b) amended...............................................24420 522.2120 Heading revised...........................................24107 522.2121 Added.....................................................24107 522.2471 (d)(1)(iii) amended........................................7701 (d)(1)(iii) corrected..........................................14818 522.2478 (c)(2) added..............................................63789 524.770 (d)(2) revised.............................................68183 524.814 (d)(2) revised.............................................59715 524.1044g (b) amended..............................................31932 524.1193 (b) and (d)(2) revised....................................44385 524.1451 Added.....................................................14036 524.1742 (b) amended................................................5255 524.2101 (c) amended...............................................26981 526.365 Redesignated from 529.365...................................8349 529.365 Redesignated to 526.365.....................................8349 529.469 Added......................................................25164 529.1030 (c) redesignated as (d); (b)(1), (2), new (d) introductory text, (1) and (2)(i) revised; (d)(2)(iv) and (v) added..................................................38304 529.1044a (b) amended...............................................6644 529.1186 (b) revised.........................................8122, 24106 529.2503 (b) amended................................................7702 556.100 Revised....................................................13337 556.113 Revised....................................................53579 556.150 Revised....................................................52158 (b) revised....................................................57246 556.167 Added......................................................13123 556.225 Revised....................................................68184 556.227 Revised....................................................59715 556.228 Undesignated text designated as (a); new introductory text, (a) heading and (b) added............................49003 556.283 Revised....................................................41191 556.286 Added......................................................38750 556.344 Revised..............................................7702, 54352 556.426 Added......................................................14036 556.500 Revised.............................................52158, 57246 556.600 Revised....................................................24107 (c) corrected..................................................38304 556.720 Revised.............................................52158, 57246 558 Technical correction......................................408, 46389 Determination..................................................15292 558.4 (d) table amended............................................11599 558.58 (d)(1)(iii) table amended...................................27845 558.76 (d)(1)(iv) table amended....................................10304 (d)(1) table amended....................................40825, 44385 (d)(3)(xv) added...............................................38475 (d)(3)(xv) added...............................................38750 (d)(3)(xvi) added..............................................39028 (d)(3)(xvii) correctly designated..............................48576 (d)(3)(xviii) added............................................51824 558.78 Regulation at 62 FR 55162 eff. date corrected to 10-23-97 9310 (a)(3) corrected...............................................14613 (d)(3) revised.................................................19185 (a)(2), (d)(1) table and (2)(ii) amended.......................27845 558.95 (d)(5)(iii) added...........................................13124 (a) revised....................................................14356 (d)(4)(iv) added...............................................18836 (d)(1)(xi)(b) and (xii)(b) amended.............................27845 (d)(4)(i)(b), (ii)(b), (iii) introductory text, (d), (iv) introductory text and (c) amended..................................44386 558.115 (d)(1)(ii) and (2)(ii) revised.............................59216 558.120 (d)(1)(iii)(b) amended.....................................27845 558.128 (d)(3)(xiv) redesignated as (d)(3)(iii)....................10304 (a)(1) and (d)(1) table amended................................27845 (d)(1) table amended....................................57246, 65554 558.145 (a)(1) and (2) amended.....................................27845 558.155 (a)(2) amended..............................................2307 (a)(2) corrected...............................................11599 558.175 (d)(1)(iii)(b) and (iv)(b) amended..................17948, 27845 558.195 (d) table amended.....................17948, 27845, 38475, 51824 558.274 (a)(6) removed; (c)(1)(i) table amended.....................5255 558.300 (c) redesignated as (d); new (d) introductory text added; new (d)(1) revised.........................................54353 558.305 (a) amended................................................27845 558.311 (e)(1)(ii) table amended...................................17948 (b)(2) through (7), (e)(1)(v) table, (2)(v) and (3)(v) amended 27845 558.325 (c)(3)(xii) revised........................................57248 558.340 (a) amended................................................27845 558.342 (d)(3)(ii) and (6)(ii) amended.............................27845 (d)(8) added...................................................41191 (c) and (d)(3)(ii) amended.....................................66018 558.355 (c) removed................................................14035 (a) amended....................................................24420 (b)(8), (9), (f)(1)(iv)(b), (v)(b), (xiv)(b), (xv)(b) and (xvi)(b) amended...................................................27845 (f)(2)(iii) added..............................................52969 (b)(11) and (f)(1)(xiv)(b) amended.............................70335 558.363 (a) revised; (c) redesignated as (d); new (d)(1)(vii) added......................................................13124 [[Page 326]] (a)(6), (d)(1)(viii) and (ix) added............................51823 (d)(2) revised.................................................57248 558.366 (c) table amended...................................13124, 57248 558.369 (c) removed; (d) introductory text revised; (d)(1), (2) and (3) redesignated as (d)(1)(i), (ii) and (iii); (d)(1) heading and (2) added......................................39028 558.450 (d)(3)(iii) added..........................................41192 558.460 (b) and (c) redesignated as (c) and (d); new (b) added; (d)(1) table revised.......................................36179 558.485 (a)(21) and (25) removed....................................5255 558.515 (d)(1)(iv)(b) amended......................................17948 (a) and (d)(1)(vi)(b) amended..................................27845 558.530 (c) removed; (d)(5)(x) revised.............................38475 558.550 (a)(1) amended..............................................6644 (a)(1), (d)(1)(vii)(c), (ix)(c), (xv)(c) and (xvi)(c) amended 27846 (a) revised; (d)(1)(xv)(c) amended.............................65554 (a)(3) revised.................................................66432 558.575 (a)(1) and (2) amended.....................................27846 558.582 (a) amended................................................27846 558.600 (c)(4)(ii) amended..................................27846, 52969 558.625 (b)(84) removed.............................................5255 558.680 (c)(1) table amended.......................................38750 573.280 Revised.....................................................8573 573.460 (b)(1), (2)(ii), (iii) and (3)(iv) revised; (b)(2)(iv) added......................................................53580 600.80 (l) correctly revised; eff. 4-6-98..........................14612 601 Authority citation revised.....................................66671 601.2 (a) introductory text amended; eff. 2-2-99....................5253 (a) introductory text amended; (c)(1)(viii) revised; eff. 6-1- 99.................................................................66399 601.12 (f)(1) amended; (f)(3)(i) revised; eff. 6-1-99..............66399 601.27 Added.......................................................66671 601.37 Added.......................................................66671 606.121 (e)(1)(ii) amended.........................................16685 610.11 (g) revised.................................................19403 Regulation at 63 FR 19403 withdrawn in part....................41718 610.30 Amended.....................................................16685 610.60 (a)(7) added; eff. 6-1-99...................................66400 640.2 (e)(3) amended...............................................16685 640.17 Amended.....................................................16685 640.24 (b) amended.................................................16685 640.64 (c)(2) amended..............................................16685 640.69 (b) amended.................................................16685 640.70 (a)(3) amended..............................................16685 640.74 (b)(2) amended..............................................16685 640.101 (a) amended................................................16685 640.102 (c) and (e) amended........................................16685 640.104 (a) amended................................................16685 800 Authority citation revised.....................................26699 801 Interpretation.................................................24934 Economic analysis statement......................29552, 46171, 50660 801.437 Note added, eff. 9-30-98 through 6-27-99; (f) and (g) stayed to 6-27-99..........................................46175 803.1 (a) revised..................................................26074 Regulation at 63 FR 26074 withdrawn............................45717 803.3 (c) introductory text amended; (m) through (ee) redesignated as (n) through (ff); (c)(1), new (p) introductory text, (1) and (r)(2) revised; (g) and new (m) added..............26074 Regulation at 63 FR 26074 withdrawn............................45717 803.9 (c)(2) amended; (c)(3) removed; (c)(4) redesignated as (c)(3).....................................................26075 Regulation at 63 FR 26075 withdrawn............................45717 803.10 Heading, (a)(2) and (c)(5) revised; (b) added...............26075 Regulation at 63 FR 26075 withdrawn............................45717 803.11 Amended.....................................................26075 Regulation at 63 FR 26075 withdrawn............................45717 803.12 (b) revised.................................................26075 Regulation at 63 FR 26075 withdrawn............................45717 803.17 Introductory text amended...................................26075 Regulation at 63 FR 26075 withdrawn............................45717 803.18 Heading, (b)(1)(ii) and (2) revised; (a), (b)(1) introductory text and (c) amended; (d) added...............26075 Regulation at 63 FR 26075 withdrawn............................45717 803.19 (b) and (c) amended.........................................26075 Regulation at 63 FR 26075 withdrawn............................45717 803.20 (a) introductory text and (2) amended; (a)(1) revised; (b)(2) added...............................................26075 Regulation at 63 FR 26075 withdrawn............................45717 [[Page 327]] 803.22 Heading revised; (a) and (b)(1) amended.....................26076 Regulation at 63 FR 26076 withdrawn............................45717 803.33 Heading revised; (a) introductory text, (2), (5), (7) introductory text, (vi) and (c) amended....................26076 Regulation at 63 FR 26076 withdrawn............................45717 803.40--803.43 (Subpart D) Added...................................26076 Regulation at 63 FR 26076 withdrawn............................45717 803.56 Introductory text, (a) and (b) amended......................26076 Regulation at 63 FR 26076 withdrawn............................45717 803.57 (a), (b), (c)(1) and (d) amended............................26076 Regulation at 63 FR 26076 withdrawn............................45717 804 Heading revised................................................26077 Regulation at 63 FR 26077 withdrawn............................45717 804.1 (a) revised..................................................26077 Regulation at 63 FR 26077 withdrawn............................45717 804.3 (d) revised; (m)(1) and (2) amended..........................26077 Regulation at 63 FR 26077 withdrawn............................45717 804.25 (a)(1) and (2) amended; (c) removed.........................26077 Regulation at 63 FR 26077 withdrawn............................45717 806 Heading revised................................................42232 Regulation at 63 FR 42232 eff. date delayed to 2 22 99.........63983 806.1 (a) and (b)(1) revised.......................................42232 Regulation at 63 FR 42232 eff. date delayed to 2 22 99.........63983 806.2 (f) revised..................................................42232 Regulation at 63 FR 42232 eff. date delayed to 2 22 99.........63983 806.10 Regulation at 62 FR 27191 eff. 5-18-98......................18836 (a), (b), (c) introductory text and (2) revised; (c)(4), (d) and (e) amended....................................................42232 Regulation at 63 FR 42232 eff. date delayed to 2 22 99.........63983 806.20 Regulation at 62 FR 27191 eff. 5-18-98......................18836 (a) and (c) revised............................................42233 Regulation at 63 FR 42233 eff. date delayed to 2 22 99.........63983 806.30 Revised.....................................................42233 Regulation at 63 FR 42233 eff. date delayed to 2 22 99.........63983 807 Heading revised................................................51826 807.3 (d)(2) and (g) revised; (s) added............................51826 807.20 (a)(4) revised; (c) removed; (d) redesignated as (c); (c)(3) added...............................................51826 Corrected......................................................65555 807.22 (c) amended.................................................51826 807.31 (d)(3) added; eff. 2-2-99....................................5253 807.87 (i), (j) and (k) redesignated as (j), (k) and (l); new (i) added; eff. 2-2-99..........................................5253 807.100 (a)(4) redesignated as (a)(5); new (a)(4) added; eff. 2-2- 99..........................................................5253 812 Authority citation revised.....................................26699 812.35 (a) revised.................................................64625 812.43 (c)(5) added; eff. 2-2-99....................................5253 812.110 (d) redesignated as (e); new (d) added; eff. 2-2-99.........5253 812.140 (b)(3) revised; eff. 2-2-99.................................5253 814.20 (b)(12) redesignated as (b)(13); new (b)(12) added; eff. 2- 2-99........................................................5253 814.39 (a) introductory text and (4) revised; (f) added............20533 Regulation at 63 FR 20533 withdrawn............................42699 (a) introductory text revised; (a)(4) removed; (a)(5) through (8) redesignated as (a)(4) through (7); (f) added..................54044 814.42 (e)(5) added; eff. 2-2-99....................................5254 814.44 (d) revised..................................................4572 814.45 (d) revised..................................................4572 814.100 (a)(2) and (d) revised; (e) added..........................19188 Regulation at 63 FR 19188 withdrawn............................40825 (a)(2) and (d) revised; (e) added..............................59220 814.104 (b) removed; (c), (d) and (e) redesignated as (b), (c) and (d); new (b)(5) and new (d) revised; new (c) amended.......19189 Regulation at 63 FR 19189 withdrawn............................40825 (b) removed; (c), (d) and (e) redesignated as (b), (c) and (d); new (b)(5) and new (d) revised; new (c) amended...............59220 [[Page 328]] 814.106 Revised....................................................19189 Regulation at 63 FR 19189 withdrawn............................40825 Revised........................................................59220 814.108 Revised....................................................19189 Regulation at 63 FR 19189 withdrawn............................40825 Revised........................................................59220 814.112 (a)(4) added; eff. 2-2-99...................................5254 814.112 (a) introductory text and (b) revised..................19189 Regulation at 63 FR 19189 withdrawn............................40825 (a) introductory text, (1) and (b) revised.....................59221 814.114 Revised....................................................19189 Regulation at 63 FR 19189 withdrawn............................40825 Revised........................................................59221 814.116 (a) and (d) amended; (e) added.............................19189 Regulation at 63 FR 19189 withdrawn............................40825 (a) and (d) amended; (e) added.................................59221 814.118 (e) revised................................................19189 Regulation at 63 FR 19189 withdrawn............................40825 (a)(8) revised; (e) removed....................................59221 814.120 Revised....................................................19189 Regulation at 63 FR 19189 withdrawn............................40825 Revised........................................................59221 814.124 (a) amended................................................19190 Regulation at 63 FR 19190 withdrawn............................40825 (a) amended....................................................59221 814.126 (a) amended; (b) revised...................................19190 Regulation at 63 FR 19190 withdrawn............................40825 (a) amended; (b) revised.......................................59221 820 Meeting.........................................................3465 860.123 (a)(10) added; eff. 2-2-99..................................5254 862.9 Heading revised; introductory text designated as (a); (a) and (b) redesignated as (a)(1) and (2); new (b) added......59224 862.1440 (b) revised...............................................59225 862.1635 (b) revised...............................................59225 862.1825 Added.....................................................40366 864.9 Introductory text designated as (a); (a) and (b) redesignated as (a)(1) and (2); new (b) added..............59225 864.1860 Added.....................................................30142 864.6100 (b) revised...............................................59225 864.6400 (b) revised...............................................59225 864.9160 (b) revised...............................................59225 864.9550 (b) revised...............................................59226 864.9575 (b) revised...............................................59226 864.9600 (b) revised...............................................59226 864.9700 (b) revised...............................................59226 866.9 Introductory text designated as (a); (a) and (b) redesignated as (a)(1) and (2); new (b) added..............59226 866.3060 (b) revised...............................................59226 866.3085 (b) revised...............................................59226 866.3135 (b) revised...............................................59226 866.3165 (b) revised...............................................59226 866.3220 (b) revised...............................................59226 866.3280 (b) revised...............................................59226 866.3300 (b) revised...............................................59226 866.3320 (b) revised...............................................59227 866.3350 (b) revised...............................................59227 866.3415 (b) revised...............................................59227 866.3550 (b) revised...............................................59227 866.3660 (b) revised...............................................59227 866.3930 (b) revised...............................................59227 866.5040 (b) revised...............................................59227 866.5320 (b) revised...............................................59227 866.5380 (b) revised...............................................59227 866.5460 (b) revised...............................................59227 866.5490 (b) revised...............................................59227 868 Preamendment device retention..................................35516 872.1870 Added.....................................................59717 872.3940 (c) revised...............................................71746 872.3950 (c) revised...............................................71746 872.3960 (c) revised...............................................71746 872.3970 (c) revised...............................................71746 876.9 Introductory text designated as (a); (a) and (b) redesignated as (a)(1) and (2); new (b) added..............59227 876.1620 (b) revised...............................................59228 876.1800 (b) revised...............................................59228 876.2040 (b) revised...............................................59228 876.4370 (b)(1) revised............................................59228 876.4650 (b) revised...............................................59228 876.4680 (b) revised...............................................59228 876.4890 (b)(1) revised............................................59228 876.5250 (b)(1) revised............................................59228 878.5040 Added......................................................7705 878.5360 Revised...................................................57060 880.9 Introductory text designated as (a); (a) and (b) redesignated as (a)(1) and (2); new (b) added..............59228 880.2200 (b) revised...............................................59228 880.2920 (b) revised...............................................59228 880.2930 Added.....................................................59718 880.5100 (b) revised...............................................59229 [[Page 329]] 880.5140 (b) revised...............................................59229 880.5475 (b) revised...............................................59229 880.5500 (b) revised...............................................59229 880.5550 (b) revised...............................................59229 880.5960 Added.....................................................59718 880.6740 (b) revised...............................................59229 880.6775 (b) revised...............................................59229 880.6910 (b) revised...............................................59229 880.6990 Added.....................................................59718 882.9 Introductory text designated as (a); (a) and (b) redesignated as (a)(1) and (2); new (b) added..............59229 882.5050 (b) revised...............................................59229 882.5970 Added.....................................................40651 884 Preamendment device retention..................................35516 884.6100--884.6190 (Subpart G) Added...............................48436 886.9 Heading revised; introductory text designated as (a); (a) and (b) redesignated as (a)(1) and (2); new (b) added......59229 886.3100 (b) revised...............................................59230 886.3130 (b) revised...............................................59230 886.3800 (b) revised...............................................59230 888.3070 Added.....................................................40040 890 Preamendment device retention..................................35516 890.9 Introductory text designated as (a); (a) and (b) redesignated as (a)(1) and (2); new (b) added..............59230 890.1925 (b) revised...............................................59230 890.3500 (b) revised...............................................59231 890.3710 (b) revised...............................................59231 890.3725 (b) revised...............................................59231 890.5160 (b) revised...............................................59231 890.5170 (b) revised...............................................59231 890.5225 (b) revised...............................................59231 890.5720 (b) revised...............................................59231 890.5740 (b) revised...............................................59231 892.9 Introductory text designated as (a); (a) and (b) redesignated as (a)(1) and (2); new (b) added..............59231 892.1980 (b) revised...............................................59231 892.2010 Added.....................................................23387 (a) and (b) corrected..........................................44998 892.2020 Added.....................................................23387 (a) and (b) corrected..........................................44998 892.2030 Added.....................................................23387 892.2040 Added.....................................................23387 892.2050 Added.....................................................23387 900.2 (d) revised; eff. 4-28-99....................................56558 900.12 (a)(2)(ii), (c)(4)(i), (d)(2) and (e)(10) amended; (a)(2)(iv)(A), (3)(iii)(B), (c)(4)(ii), (e)(1) introductory text, (8)(ii)(A) and (f)(3) revised; eff. 4- 28-99; (e)(4)(iii)(B) revised; eff. 10-28-02...............56558 1220 Removed; eff. 4-17-98.........................................12996 1240 Technical correction..........................................29591 1240.70 Removed....................................................26078 1270.33 (b)(1) amended.............................................16685 1999 21 CFR 64 FR Page Chapter I 2 Authority citation revised.........................................398 Effective date confirmation....................................26657 3 Authority citation revised.........................................398 Effective date confirmation....................................26657 3.2 (k) amended; eff. 5-20-99........................................398 (k) revised....................................................56447 5 Effective date confirmation......................................26657 5.20 (h) revised...................................................59618 5.22 (a)(10)(v) revised; (a)(10)(vi) added..........................4965 (a)(13)(viii) removed..........................................49383 5.23 (c)(5) added...................................................4965 5.31 (f)(2)(v), (vi) and (vii) amended; eff. 5-20-99.................398 (f)(3) revised.................................................49383 5.37 (a)(2)(iv) and (b)(4) added....................................4965 5.58 (a)(3) revised................................................56448 5.60 (b)(8) correctly revised; CFR correction......................14098 5.61 (i) added.....................................................33194 5.67 Heading and introductory text revised; (e) added..............47669 (a), (b) and (c) revised.......................................56448 5.70 Amended; eff. 5-20-99...........................................398 5.75 Removed; eff. 5-20-99...........................................398 5.76 Removed; eff. 5-20-99...........................................398 5.78 Removed; eff. 5-20-99...........................................398 5.83 (c)(1) revised................................................23184 5.93 (b) revised...................................................49383 5.98 Revised........................................................4965 5.101 Added........................................................59618 10 Effective date confirmation.....................................26657 10.20 (c)(1)(iii) and (iv) amended; (c)(1)(v) removed; eff. 4-24- 00.........................................................69190 10.50 (a)(2) amended; (c)(11) removed; eff. 5-20-99..................398 (c)(19) revised................................................56448 10.55 (c) amended; eff. 5-20-99......................................398 10.80 (g) amended; eff. 5-20-99......................................398 [[Page 330]] 12 Authority citation revised........................................399 Effective date confirmation....................................26657 12.20 (a) introductory text and (2)(i) amended; (c) removed; eff. 5-20-99......................................................399 12.22 (a)(5)(i)(a) and (b) amended; (a)(5)(i)(c) removed; eff. 4- 24-00......................................................69190 12.24 (b)(6) and (c) amended; eff. 5-20-99...........................399 12.87 (d) amended; eff. 5-20-99......................................399 16 Effective date confirmation.....................................26657 16.1 (b)(2) amended; eff. 5-20-99....................................399 20 Authority citation revised........................................399 Effective date confirmation....................................26657 20.100 (c)(20) and (21) removed; eff. 5-20-99........................399 (c)(24) revised................................................56448 20.117 (a)(3) amended; eff. 5-20-99..................................399 25 Effective date confirmation.....................................26657 25.5 (b)(1) amended; eff. 5-20-99....................................399 25.31 (f) and (h) removed; (g) and (i) through (l) redesignated as (f) and (g) through (j); eff. 5-20-99........................399 25.32 (i) and (j) corrected; CFR correction........................56454 26 Docket establishment............................................11376 Meeting........................................................57776 26.1 (c) corrected.................................................16348 26.31--26.50 (Subpart B) Appendix B corrected......................16348 50 Authority citation revised.................................399, 10942 Effective date confirmation....................................26657 50.1 (a) amended; eff. 5-20-99.......................................399 50.3 (b)(11) removed; (c) amended; eff. 5-20-99......................399 (b)(12) revised................................................56448 50.20 Amended......................................................10942 50.23 (d)(1) amended; eff. 5-20-99...................................399 (d) revised; interim...........................................54188 54 Authority citation revised........................................399 Effective date confirmation....................................26657 54.4 (a) amended; eff. 5-20-99.......................................399 56 Authority citation revised........................................399 Effective date confirmation....................................26657 56.101 (a) amended; eff. 5-20-99.....................................399 56.102 (b)(11) revised.............................................56448 (b)(10) removed; (b)(11) through (21) redesignated as (b)(10) through (20); (c) amended; eff. 5-20-99..............................399 58 Authority citation revised........................................399 Effective date confirmation....................................26657 58.1 (a) amended; eff. 5-20-99.......................................399 58.3 (e)(9) removed; eff. 5-20-99....................................399 (e)(13) revised................................................56448 60 Authority citation revised........................................399 Effective date confirmation....................................26657 60.3 (b)(5), (10), (11)(i) and (12)(i) amended; eff. 5-20-99.........399 60.22 (a)(1) and (2) revised; eff. 5-20-99...........................400 70 Effective date confirmation.....................................26657 70.10 Heading and (b) heading revised; (b)(1), (2) and (3) amended; eff. 5-20-99........................................400 71 Authority citation revised........................................400 Effective date confirmation....................................26657 71.2 (a) amended; eff. 5-20-99.......................................400 74 Effective date confirmation.......................39414, 57974, 62582 74.1102 (b)(1) and (c)(1) removed; (b)(2) and (c)(2) redesignated as (b) and (c).............................................48290 74.3045 (c)(1) introductory text revised...........................23186 74.3102 Added......................................................48290 74.3602 (b)(4) redsignated as (b)(5); new (b)(4) added.............32805 101 Workshop.......................................................34125 Comment period reopening.......................................42277 101.4 (b)(23) added................................................50448 101.9 (b)(5)(i) revised; eff. 1-1-02...............................12889 101.12 (b) Table 2 amended; eff. 1-1-02............................12890 101.65 (d)(2)(ii)(C), (3)(ii)(C) and (4)(ii)(B) stayed; eff. 3-16- 99 through 1-1-03..........................................12887 101.82 Added (effective date pending in part)......................57732 172.345 (b) revised.................................................1758 172.665 (d)(2) revised..............................................1758 172.723 (b)(3) revised..............................................1759 172.831 Introductory text removed; (c) revised.....................43909 172.833 Added......................................................29958 (c) corrected..................................................43072 172.836 (c)(16) added..............................................57976 172.886 (c)(2) revised.............................................44122 173.25 (b)(5) and (d)(2) revised...................................14609 (b)(2)(i) and (ii) added.......................................56173 173.310 (c) table amended....................................1759, 29227 173.315 (a)(2) table amended; (a)(5) added.........................38564 173.325 (b)(1) revised.............................................26841 (d) redesignated as (e); new (d) added.........................44123 [[Page 331]] (e) redesignated as (f); new (e) added.........................49982 175.105 (c)(5) table amended................................29554, 45872 175.125 (b)(2) amended.............................................48291 175.300 (b)(3)(viii)(a) amended....................................60106 (b)(3)(vii)(a) corrected; CFR correction........................4535 175.320 (b)(3) table amended........................................2568 176.170 (a)(5) table amended.......................................27915 176.180 (b)(2) table amended................................46132, 68631 176.300 (c) table amended...................................46130, 69900 177.1200 (c) table amended.........................................57978 177.1211 Added.....................................................28098 177.1350 (a) introductory text, (1) through (6) and (b) redesignated as (a)(1) introductory text, (i) through (vi) and (b)(1); new (a)(2) and (b)(2) added....................47108 177.1390 (c)(1)(i)(e) redesignated as (c)(1)(i)(f); new (c)(1)(i)(e) added..........................................4785 (c)(1)(i)(f) revised...........................................46272 177.1500 (b) table amended...................................46272, 4786 177.1520 (c) table amended..................................10944, 27916 (a)(2) redesignated as (a)(2)(i); (a)(2)(ii) and (3)(vi) added; (d)(7) table amended........................................47108 (a)(3)(ii) revised; (c) table amended..........................71638 177.1585 (a) and (c)(1) revised....................................27178 178 Technical correction...........................................27854 178.2010 (b) table amended.........34, 2854, 13507, 24944, 25429, 26282, 30386, 48293, 53926, 65658, 66104, 67485, 72273 (b) table corrected................................................46133 178.3130 (b) corrected; CFR correction..............................4535 (b) table amended..............................................62585 178.3295 Table amended.............................................26843 178.3297 (e) table amended....................26842, 44406, 44407, 72275 178.3400 (c) table amended.........................................45874 178.3570 (a)(3) table amended...............................47670, 71639 178.3620 (c)(3) corrected; CFR correction...........................4535 178.3725 Table amended......................................48292, 72273 178.3910 (a)(2) table corrected; CFR correction.....................4535 (a)(2) table amended...........................................47110 179.21 (a)(1) revised..............................................69191 184.1007 (b)(1), (6) and (7) revised................................1759 184.1148 Added.....................................................19894 184.1150 Added.....................................................19895 184.1250 Added.....................................................28361 184.1257 (b) introductory text and (1) revised......................1759 184.1259 (b)(3) revised.............................................1760 184.1282 (b) revised................................................1760 184.1293 (b) revised................................................1760 184.1428 (a) amended.................................................405 184.1530 (b) revised................................................1760 184.1699 (b) revised................................................1760 184.1979 (b)(1) introductory text and (2) revised...................1760 184.1979a (b)(1) introductory text and (2) revised..................1761 184.1979b (b)(1) introductory text and (2) revised..................1761 Corrected.......................................................7066 184.1979c (b)(1) introductory text and (2) revised..................1761 200 Authority citation revised.......................................400 Effective date confirmation....................................26657 201 Authority citation revised.......................................400 Compliance date................................................13066 Regulation at 64 FR 13292 eff. date corrected to 5-16-99.......18571 Effective date confirmation....................................26657 201.59 (a)(1) revised; eff. 5-20-99..................................400 201.63 Heading and (e) revised; (a) amended; eff. 4-16-99..........13286 Regulation at 64 FR 13286 eff. date corrected to 5-16-99.......18571 201.64 (b) amended; eff. 4-16-99...................................13286 Regulation at 64 FR 13286 eff. date corrected to 5-16-99.......18571 201.66 Added; eff. 4-16-99.........................................13286 Regulation at 64 FR 13286 eff. date corrected to 5-16-99.......18571 201.100 (c)(2) and (d)(1) amended; eff. 5-20-99......................400 201.150 (e) through (h) removed; eff. 5-20-99........................400 201.314 (a) amended; (g)(1) and (h)(1) revised; eff. 4-16-99.......13291 201.319 (b) revised; eff. 4-16-99..................................13292 Regulation at 64 FR 13292 eff. date corrected to 5-16-99.......18571 201 Appendix A added; eff. 4-16-99.................................13292 202 Authority citation revised.......................................400 Effective date confirmation....................................26657 202.1 (e)(4)(ii) removed; (e)(4)(iii) redesignated as (e)(4)(ii); new (e)(4)(ii), (6)(i), (ii)(a), (b) and (xvii) amended; eff. 5-20-99.................................................400 203 Added; eff. 12-4-00............................................67756 [[Page 332]] 205.3 (f)(9), (10) and (h) added; eff. 12-4-00.....................67762 205.50 (f)(2) revised; eff. 12-4-00................................67763 206 Authority citation revised.......................................400 Effective date confirmation....................................26657 207 Authority citation revised.......................................400 Effective date confirmation....................................26657 207.10 (f) revised.................................................63203 207.20 (c) amended; eff. 5-20-99.....................................400 (c) revised....................................................56448 (c) amended....................................................63203 207.21 (a) amended; eff. 5-20-99.....................................400 (a) amended....................................................56448 (a) amended....................................................63203 207.25 (b)(2), (4), (5) and (6) amended; eff. 5-20-99................400 207.31 (a)(1), (2), (3) and (c) amended; eff. 5-20-99................400 207.35 (b)(3)(v) amended; eff. 5-20-99...............................400 207.37 (a)(2)(i) amended; eff. 5-20-99...............................400 210 Authority citation revised.......................................401 Effective date confirmation....................................26657 211 Authority citation revised.......................................401 Effective date confirmation....................................26657 216 Added; eff. 4-17-99............................................10947 225.1 (b)(2) revised; (c) added....................................63203 225.58 (b)(1) amended..............................................63203 225.115 (b)(2) revised.............................................63203 299 Effective date confirmation....................................26657 299.4 (d) amended; eff. 5-20-99......................................401 300 Authority citation revised.......................................401 Effective date confirmation....................................26657 300.50 (b) amended; eff. 5-20-99.....................................401 310 Authority citation revised.......................................401 Effective date confirmation....................................26657 310.4 Revised......................................................56448 310.502 (a) introductory text revised; (b) removed; eff. 5-20-99 401 310.503 (b) amended................................................56449 310.516 Removed; eff. 11-16-00.....................................62112 310.545 (a)(12)(iv) redesignated as (a)(12)(iv)(A); (a)(12)(iv)(A) heading, (d) introductory text and (1) revised; (a)(12)(iv)(B) and (d)(29) added............................4540 (a)(29) and (d)(31) added; (d) introductory text revised; eff. 5-21-01............................................................27687 310.548 Added......................................................44658 312 Authority citation revised................................401, 54189 Effective date confirmation.............................19269, 26657 312.2 (a) and (d) amended; eff. 5-20-99..............................401 312.3 Amended; eff. 5-20-99..........................................401 (b) amended....................................................56449 312.42 (b)(6) added; interim.......................................54189 312.80--312.88 (Subpart E) Authority citation revised................401 312.81 Introductory text amended; eff. 5-20-99.......................401 312.110 (b)(4) revised; (b)(5) removed; eff. 5-20-99.................401 312.120 (a) amended; eff. 5-20-99....................................401 312.130 (b) amended; eff. 5-20-99....................................401 314 Authority citation revised.......................................401 Heading revised; eff. 5-20-99....................................401 Effective date confirmation....................................26657 314.1 (a) revised; eff. 5-20-99......................................401 314.50 (d) introductory text amended; eff. 5-20-99...................401 314.81 (a) amended; eff. 5-20-99.....................................401 314.92 (a)(2) removed; eff. 5-20-99..................................401 314.94 (c) and (d)(3) removed; eff. 5-20-99..........................401 314.96 (c) removed; eff. 5-20-99.....................................401 314.98 (a) and (c) amended; eff. 5-20-99.............................401 314.100 (a) amended; eff. 5-20-99....................................402 314.101 Heading revised; (a)(2) amended; eff. 5-20-99................402 314.105 (a) and (b) amended; eff. 5-20-99............................402 314.110 (a)(2), (4) and (5) amended; eff. 5-20-99....................402 314.120 (a) introductory text, (3) and (5) amended; (a)(4) removed; eff. 5-20-99........................................402 314.125 Heading revised; (a) introductory text, (2) and (b)(2) amended; eff. 5-20-99........................................402 314.126 (a) amended; eff. 5-20-99....................................402 314.150 (a) introductory text and (b) introductory text amended; eff. 5-20-99.................................................402 314.170 Amended; eff. 5-20-99........................................402 314.300 (Subpart F) Removed; eff. 5-20-99............................402 314.410 Heading revised; (a)(1) introductory text, (i) and (b)(1) amended; (b)(3) revised; eff. 5-20-99........................402 [[Page 333]] 314.430 (e)(8) removed; (f)(6) amended; eff. 5-20-99.................402 314.500 Amended; eff. 5-20-99........................................402 314.530 (a) amended; eff. 5-20-99....................................402 315 Added..........................................................26667 316 Effective date confirmation....................................26657 316.3 (b)(9) amended; eff. 5-20-99...................................402 316.3 (b)(9) revised...........................................56449 320 Authority citation revised.......................................402 Effective date confirmation....................................26657 320.38 (a) amended; eff. 5-20-99.....................................402 320.63 Amended; eff. 5-20-99.........................................402 330.1 (c)(1), (2), (i) and (j) revised; (g) amended; eff. 4-16-99 13294 Regulation at 64 FR 13294 eff. date corrected to 5-16-99.......18571 331.30 (d) revised; eff. 4-16-99...................................13295 Regulation at 64 FR 13295 eff. date corrected to 5-16-99.......18571 333 Effective date confirmation....................................26657 333.103 (a) and (b) designation removed; eff. 5-20-99................403 333.110 (a) through (f) amended; eff. 5-20-99........................403 333.120 (a)(1) through (12) and (b)(1) through (6) amended; eff. 5-20-99......................................................403 341.74 (c)(4)(v) and (vi) revised; eff. 4-16-99....................13295 Regulation at 64 FR 13295 eff. date corrected to 5-16-99.......18571 341.76 (c)(4) revised; eff. 4-16-99................................13295 Regulation at 64 FR 13295 eff. date corrected to 5-16-99.......18571 341.80 (c)(1)(i)(D) and (ii)(D) revised; eff. 4-16-99..............13295 Regulation at 64 FR 13295 eff. date corrected to 5-16-99.......18571 343.80 (a)(1) revised..............................................49653 346.50 (c)(7)(ii) revised; eff. 4-16-99............................13295 Regulation at 64 FR 13295 eff. date corrected to 5-16-99.......18571 352 Added; eff. 5-21-01............................................27687 355.50 (c)(1) and (2) revised; eff. 4-16-99........................13296 Regulation at 64 FR 13296 eff. date corrected to 5-16-99.......18571 358.650 (d)(1) amended; eff. 4-16-99...............................13296 Regulation at 64 FR 13296 eff. date corrected to 5-16-99.......18571 369 Authority citation revised.......................................403 Effective date confirmation....................................26657 369.9 Revised; eff. 4-16-99........................................13296 Regulation at 64 FR 13296 eff. date corrected to 5-16-99.......18571 369.20 Amended; eff. 4-16-99.......................................13296 Regulation at 64 FR 13296 eff. date corrected to 5-16-99.......18571 369.21 Amended; eff. 4-16-99.......................................13296 Regulation at 64 FR 13296 eff. date corrected to 5-16-99.......18571 510 Effective date confirmation....................................26657 510.3 (l) removed; eff. 4-24-00....................................69190 510.7 (a)(1) and (2) revised.......................................63203 510.45 Removed; eff. 5-20-99.........................................403 510.95 Removed; eff. 4-24-00.......................................69190 510.105 (a) and (b) amended........................................51241 510.110 (e) and (f) amended; eff. 5-20-99............................403 510.301 Heading revised............................................63203 510.305 Revised....................................................63203 510.600 (c)(1) table and (2) table amended...15683, 18571, 23187, 42597, 48294, 69191 514 Effective date confirmation....................................26657 514.1 (b)(8)(ii) and (v) revised...................................40756 514.2 Removed......................................................63203 514.4 Added........................................................40756 514.9 Removed......................................................63203 514.10 Removed; eff. 5-20-99.........................................403 514.105 (a) introductory text and (b) removed; (a)(1) and (2) redesignated as (a) and (b); new (a) amended...............63203 514.111 (a)(5) revised.............................................40757 (b) removed; (c) redesignated as (b)...........................63204 514.112 Removed....................................................63204 514.115 (a), (b), (c) introductory text, (1), (3), (d) and (e) amended....................................................63204 514.201 Revised....................................................63204 515.5 Added........................................................63204 520 Effective date confirmation....................................26657 520.45a (a)(4)(i)(1) designation and (2) removed; (b)(1) revised 1504 520.48 (b) amended.................................................42597 520.154a (a) and (d)(2) amended....................................13068 520.260 (b) amended................................................15684 520.309 Heading and (a) revised; (c) redesignated as (d); new (d)(1) and (2) revised.....................................32181 520.455 Added.......................................................1762 [[Page 334]] 520.445b (d)(4)(iii)(C)amended.....................................37673 520.534 Added......................................................10103 (d) heading amended............................................30387 520.600 (i) revised................................................18571 520.812 (a) amended................................................48295 520.1204 (a) amended; eff. 5-20-99...................................403 520.1263a (a) revised; eff. 5-20-99..................................403 520.1263b (a) amended; eff. 5-20-99..................................403 520.1263c (d)(1)(i)(C) amended.....................................13341 (a) amended; (b) revised.......................................13508 (b) amended....................................................66382 520.1310 Added.....................................................39919 520.1452 (d)(2) and (3) revised....................................66105 520.1484 Revised...................................................31497 520.1615 Added.....................................................18573 520.1660d (a)(9) and (b)(7) added; (b)(2) revised..................10389 (a)(7) revised; (c) removed; (d) and (e) redesignated as (c) and (d)............................................................13341 (a)(8), (d)(1)(ii)(A)(3), (B)(3) and (C)(3) amended............13678 (a)(1), (2) and (7) amended....................................48544 520.1807 Added.....................................................23018 520.2098 (d)(2) and (d)(3) redesignated as (d)(1)(i) and (ii); new (d)(2) added................................................2122 520.2158b (d) correctly added; CFR correction.......................4540 520.2184 (b) amended...............................................15684 520.2220a (a)(2) amended...........................................18572 520.2220b (a) removed; (b), (d) and (e) redesignated as (a), (b) and (d); new (a) and new (d)(2) revised....................15684 520.2260a Heading and (a)(1) revised; (a)(4) removed...............66383 520.2345d (a)(1) amended...........................................37673 520.2613 (b) amended...............................................68289 522 Effective date confirmation....................................26657 522.147 (b) amended................................................71640 522.690 (b) amended................................................15685 522.723 (c) amended................................................15684 522.770 (d)(1)(ii) amended.........................................13509 522.800 (b) amended................................................15684 522.842 (a) and (e) removed; (b) and (d) introductory text revised; (d)(1) redesignated as (d)(1)(i); (d)(1)(ii) added......................................................48294 522.955 (d)(1)(i) revised; (d)(1)(ii) redesignated as (d)(1)(i)(B); (d)(1)(ii)(A) and (B) added...................5596 (d)(1)(i)(B) revised............................................9435 522.1081 (a)(3) and (b)(3) redesignated as (a)(4) and (b)(4); (a)(2)(i), (ii), (iii) and new (b)(4)(iii) amended; new (a)(3), (5) and new (b)(3) added; (a)(4) heading, (i) and (b)(4) heading revised; (a)(4) footnote removed............48544 522.1192 (d)(2)(ii) amended........................................26671 522.1193 (d)(2) amended............................................26671 522.1204 (a) revised; eff. 5-20-99...................................403 522.1484 (a) amended; eff. 5-20-99...................................403 522.1660 (b) and (d)(2)(iii) amended...............................23187 (d)(2)(iii) revised............................................26670 (d)(1)(iii) amended............................................42831 522.1940 (d)(1)(i) and (2)(i) redesignated as (d)(1)(i)(A) and (2)(i)(A); (b), new (d)(1)(i)(A) and new (2)(i)(A) revised; (d)(1)(i)(B) and (2)(i)(B) added..................48294 522.2005 (b) revised; (c)(2) added.................................13510 522.2100 (a)(1), (b)(1), (c)(1), (d)(1) and (e)(1) amended.........27916 522.2476 (b) amended...............................................42597 (b) revised; (d)(1) and (2) redesignated as (d)(1)(i) and (2)(i); (d)(1)(ii) and (2)(ii) added...............................48294 522.2477 (a) amended...............................................42597 (a), (b) and (c) redesignated as (b), (c) and (d); new (d)(1)(i) redesignated as (d)(1)(i)(A); new (b) revised; (d)(1)(i)(B) added.................................................48294 522.2478 (c) redesignated as (d); new (d)(1)(ii) revised...........18573 522.2680 (d)(3)(ii) amended........................................46840 524 Effective date confirmation....................................26657 524.770 (d)(2) revised.............................................49082 524.1200a (a)(1) and (2) designation removed; eff. 5-20-99...........404 524.1200b (a) revised; eff. 5-20-99..................................404 524.1204 (a)(1) removed; (a)(2)(i), (ii), (iii) and (3) redesignated as (a)(1)(i), (ii), (iii) and (2); eff. 5-20- 99...........................................................404 524.1600a (b) revised; (c)(1)(i) footnote, (ii) footnote, (iii) footnote, (2)(i) footnote and (2)(ii) footnote removed.....42831 524.2098 Added.....................................................37401 [[Page 335]] (d)(1) and (2) amended.........................................48707 529 Effective date confirmation....................................26657 529.360 (a) amended; eff. 5-20-99....................................404 529.2150 Added.....................................................71640 556.34 Revised......................................................1504 556.170 Revised....................................................10103 556.175 Added......................................................35923 556.304 Added......................................................48545 556.344 (b)(2)(ii) added...........................................26671 556.347 Revised....................................................13069 556.360 Revised....................................................13342 556.420 Revised.....................................................5159 556.430 Revised....................................................31498 556.490 Revised....................................................26672 556.513 Added......................................................23019 556.597 Added......................................................48296 556.640 Revised....................................................26672 556.735 Revised....................................................13679 556.739 Revised....................................................18574 556.750 Revised....................................................48296 558.3 (b)(2) through (5) amended...................................63206 558.4 Heading, (a), (b) and (c) revised............................63206 (d) table amended.......................................70576, 72027 558.15 (g)(1) table and (2) table amended............................992 (g)(1) and (2) amended.........................................37673 558.76 (d)(3)(xix) added............................................4966 (d)(3)(xx) added...............................................13342 (d)(3)(xxi) added..............................................18574 558.78 (d)(3)(xii) revised.........................................26844 558.95 (d)(1)(xiv) added...........................................49083 (d)(5) introductory text revised; (d)(5)(iv) added.............49384 558.128 (d)(1) table amended.......................................23539 558.140 (a) amended................................................15684 558.198 Added......................................................35923 558.258 (c)(1)(i) introductory text amended........................26844 558.265 (a) amended................................................42597 558.300 (d)(1)(ii), (2)(ii), (3)(ii), (4)(ii) and (5)(ii) amended; (d)(6) added...............................................13342 558.311 (b)(4) revised.............................................13069 (e)(1)(xiv) revised............................................26845 (e)(4)(ii) added...............................................49083 (e)(1)(xiv) table amended......................................49656 558.325 (c) redesignated as (d); (d)(2)(ii)(b), (iii)(b) and (iv)(b) amended............................................13342 558.355 (f)(3)(ii)(b) amended.......................................2855 (d)(7)(ii), (f)(3)(iii)(a), (b), (vi)(a), (b), (vii)(a) and (b) revised; (f)(3)(xi) added.......................................5159 (b)(11) amended; (f)(1)(xxvi) and (xxvii) added.................5597 (f)(2)(iv) added...............................................13069 558.363 (d)(2)(ii) added............................................4966 (d)(2)(iii) added..............................................18574 (d)(2)(iv) added...............................................20164 558.364 Added......................................................70576 558.366 (c) table amended......................4966, 18574, 20164, 49384 558.485 (a)(17) removed............................................15684 (e)(2)(i) introductory text and (A) revised; (e)(2)(i)(B) amended............................................................53927 558.530 (d)(5)(xxv) added..........................................18575 (d)(5)(xxvi) added.............................................20164 558.555 (b) redesignated as (d); new (b), (c), (d)(5), (6) and (7) added; new (d) heading revised; new (d)(1) introductory text removed...............................................48296 558.575 (a) revised; (c) redesignated as (d); (d)(7) added.........26672 (d)(4)(ii)(a) amended..........................................43910 558.618 (d)(3) amended.............................................13679 558.635 (b)(2) amended.............................................15684 (a), (c), (e)(3) and (4) removed; (b), (d), (e) and (f) redesignated as (a) through (d); new (a)(1), (2) and (d)(2)(i) amended; new (d)(4)(vii) added.....................................48296 564 Removed.........................................................4294 Technical correction............................................6801 573 Announcement...................................................46841 573.625 Revised....................................................46840 600.3 (n) and (w) revised..........................................56449 600.15 (b) revised.................................................56449 600.21 Amended.....................................................56449 600.80 (b) and (c)(2)(i) amended; (g) and (j) revised..............56449 600.81 Amended.....................................................56449 601 Authority citation revised.....................................26668 601.1 Removed......................................................56450 601.2 Revised......................................................56450 601.3 Removed......................................................56450 601.4 (a) revised; (b) amended.....................................56450 601.5 Revised......................................................56451 601.6 Revised......................................................56451 601.9 Revised......................................................56451 601.10 Removed.....................................................56451 601.20 Revised.....................................................56451 601.21 Revised.....................................................56451 601.22 Amended; heading revised....................................56452 601.25 (b)(3) and (f)(3) amended...................................56452 601.26 (e) introductory text, (f)(1), (2) and (3) amended..........56452 [[Page 336]] 601.28 Redesignated from 601.33....................................26668 601.30--601.35 (Subpart D) Revised.................................26668 601.33 Redesignated as 601.28......................................26668 601.51 Heading and (b) revised; (a) amended........................56452 606.3 (c), (e), (f) and (j) revised................................45370 606.100 (b) introductory text, (b)(7), (18) and (d) introductory text revised...............................................45370 606.121 (a), (d)(2) and (e)(1)(ii) revised.........................45370 606.122 (f) and (n)(4) revised.....................................45371 606.151 (b), (c) and (e) revised...................................45371 606.160 (b)(2)(v) revised..........................................45371 606.170 (b) revised................................................45371 607.20 (b) revised.................................................56452 607.21 Amended.....................................................56453 610.13 Introductory text revised; (a)(1) amended...................56453 610.53 (d) revised.................................................56453 610.63 Revised.....................................................56453 640.2 (b) and (d) removed; (c), (e) and (f) redesignated as (b), (c) and (d); new (b) and new (c)(2) revised................45371 640.3 (b) introductory text, (3), (c)(1), (2) and (3) revised; (e) removed....................................................45371 640.4 (b), (d), (g) introductory text, (1), (2), (4) and (5) revised; (d)(1) through (4) and (h) removed; (i) redesignated as (h)........................................45371 640.5 Introductory text and (c) revised............................45372 640.6 (c) removed..................................................45372 Introductory text revised......................................56453 640.13 (a) revised.................................................45372 640.15 Revised.....................................................45372 640.16 (a) and (b) revised.........................................45372 640.21 (c) revised.................................................56453 640.22 (a) revised.................................................45372 (c) revised....................................................56453 640.23 (a) revised.................................................45372 640.24 (b) revised.................................................45372 640.31 (c) removed.................................................45372 640.32 (a) amended.................................................45372 640.34 (a) through (d), (e)(1), (2), (3) and (g)(2) revised........45372 640.51 (c) removed.................................................45373 640.52 (a) revised.................................................45373 640.54 (a)(2) revised..............................................45373 640.56 (c) introductory text revised...............................45373 640.62 Revised.....................................................45373 640.63 (c)(3), (5), (11), (12) and (13) revised....................45373 640.64 (c) introductory text amended...............................56453 640.65 (b)(4) and (5) revised; (b)(8) added........................45373 (a) amended....................................................56453 640.69 (d) revised.................................................45374 640.71 (a) introductory text revised...............................45374 (a) introductory text, (b) introductory text and (1) revised 56453 640.72 (a)(1) revised..............................................45374 640.74 (a) revised; (b)(2) amended.................................56453 640.80 (a) amended; (b) revised....................................26286 640.81 (c) and (e) amended; (f) revised............................26286 640.82 (a) heading, (c) heading, (d) and (e) revised...............26286 640.84 (a) introductory text and (b) removed; (a)(1) through (4) redesignated as (a) through (d); introductory text, new (a) and new (d) revised....................................26286 640.90 (a) amended; (b) revised....................................26286 640.91 (b)(2) and (f) revised; (c) and (e) amended.................26286 640.92 (a) heading, (c) heading, (d) and (e) revised...............26286 640.94 (a) revised.................................................26286 640.100 (a) amended; (b) and (c) revised...........................26287 640.101 (b) amended; (e)(3), (4) and (f) removed...................26287 640.102 (e) amended................................................26287 640.103 (b) revised................................................26287 640.104 (b)(2), (3), (c)(1) and (2) revised........................26287 660.21 (a)(3) and (d) revised......................................56454 660.30 (b) revised.................................................56454 660.33 Amended.....................................................56454 700.35 Added; eff. 5-21-01.........................................27693 701.3 (d) revised; eff. 4-16-99....................................13297 701.3 Regulation at 64 FR 13297 eff. date corrected to 5-16-99.....18571 740.19 Added; eff. 5-22-00.........................................27693 800 Authority citation revised.......................................404 800 Effective date confirmation....................................26657 801 Authority citation revised.......................................404 801 Effective date confirmation....................................26657 801.420 (c)(4) amended.............................................59620 805 Removed........................................................66106 [[Page 337]] 806 Authority citation correctly revised; CFR correction...........14098 807 Effective date confirmation..............................1762, 26657 807.25 (f)(3) amended; eff. 5-20-99..................................404 809 Authority citation revised.......................................404 809 Effective date confirmation....................................26657 809.5 Removed; eff. 5-20-99..........................................404 809.6 Removed; eff. 5-20-99..........................................404 812 Authority citation revised................................404, 10942 812 Effective date confirmation....................................26657 812.20 (a)(4)(i) amended...........................................10942 812.47 (b) amended.................................................10943 860 Effective date confirmation....................................26657 860.84 (a) amended; eff. 5-20-99.....................................404 862.1715 (b) revised................................................1124 874.1050 (b) revised...............................................14831 874.3900 Added; eff. 4-17-99.......................................10949 874.4780 Added; eff. 4-17-99.......................................10949 874.4800 Added; eff. 4-17-99.......................................10949 874.5350 (c) revised...............................................18329 874.5370 (c) revised...............................................18329 876.1735 Added.....................................................51444 878.3530 (c) revised...............................................45161 Regulation at 64 FR 45161 eff. date corrected to 8-19-99.......46010 878.4014 Added.....................................................53929 878.4018 Added.....................................................53929 878.4020 Added.....................................................53929 878.4022 Added.....................................................53929 882.5860 (c) revised...............................................18329 884.6190 (a) amended; (b) revised..................................62977 890.5275 (c) revised...............................................18331 890.5300 (c) revised...............................................18331 890.5860 (c) revised...............................................18331 892.5050 (b) revised................................................1125 900.2 (yy) added...................................................32407 Regulation at 64 FR 32407 eff. date delayed to 1-28-00.........53195 900.4 (a)(4) amended; (c)(3)(ii), (5) introductory text, (i), (ii) and (6)(ii) revised........................................32407 Regulation at 64 FR 32407 eff. date delayed to 1-28-00.........53195 900.12 (b)(5) and (e)(5)(vii)(A) revised...........................18333 (c)(2) and (f)(3) revised; (j)(2) amended......................32408 Regulation at 64 FR 32408 eff. date delayed to 1-28-00.........53195 1020.30 (b) amended................................................35927 1020.31 (a)(2)(i), (f)(3) and (m) revised..........................35927 Chapter II 1308 Technical correction...................................39560, 42432 1308.4 (e)(7) through (11) redesignated as (e)(8) through (12); new (e)(7) added............................................4052 1308.12 (f)(1) removed; (f)(2) redesignated as (f)(1)..............35930 1308.13 (g) added..................................................35930 (c)(5) through (11) redesignated as (c)(6) through (12); new (c)(5) added.......................................................37675 1308.14 (c)(48) redesignated as (c)(49); new (c)(48) added.........49983 1309.29 Regulation at 62 FR 53960 confirmed........................40516 1310.09 Regulation at 62 FR 53960 confirmed........................40516 1312 Technical correction..........................................42432 1312.30 (a) added..................................................35930 Chapter III 1401 Revised.......................................................69901 2000 21 CFR 65 FR Page Chapter I 5.20 (b), (c), (e), (f) and (g) revised; (i) redesignated as (j); new (i) added..............................................34960 5.22 (a)(1), (2), (3), (6), (7), (10)(ii), (11)(ii), (12)(ii), (b)(1), (2), (3) and new (d) revised; (c) redesignated as (d); new (c) added.........................................34961 5.23 (a)(1), (2), (4) and (d) revised..............................34961 5.25 (a)(7) and (c) revised........................................34962 5.27 Revised.......................................................34962 5.30 (c)(1) revised................................................34962 5.32 Revised.......................................................34962 5.34 (a) revised...................................................34962 5.58 (a) introductory text and (b) introductory text revised.......34962 5.81 Revised.......................................................34962 5.200 Revised......................................................19830 5.210 Revised......................................................19832 5.215 Revised......................................................19832 7.1 Amended........................................................56476 7.40--7.59 (Subpart C) Heading revised.............................56476 7.40 (a) amended...................................................56476 10 Effective date confirmation.....................................17134 Authority citation revised.....................................25440 [[Page 338]] 10.20 (j)(1)(v) amended............................................56477 10.45 (d) amended..................................................56477 10.85 (d)(5) removed...............................................56477 10.90 (b) amended..................................................56477 10.115 Added.......................................................56477 12 Effective date confirmation.....................................17134 13 Authority citation revised......................................25440 14 Authority citation revised......................................25440 14.27 (b)(3) amended...............................................56479 14.33 (c) amended..................................................56479 15 Authority citation revised......................................25440 16.5 (a)(4) added; eff. 9-4-01.....................................76110 19.10 (c) amended..................................................56479 20.88 (e)(1) revised; eff. 5-22-00.................................11887 20.89 (d)(1) revised; (d)(3) removed; (e) added; eff. 5-22-00......11888 25 Effective date confirmation.....................................60359 25.20 (i) revised..................................................30355 25.30 (h) amended..................................................56479 25.32 (i), (j), (k), (q) and (r) revised...........................30355 50.3 (b)(11) correctly removed; CFR correction.....................81739 56.102 (b)(10) and (11) revised....................................52302 71.1 (a) and (c) amended; (j) added (effective date pending).......51762 71.20 (a)(3) added.................................................51762 73 Comment period extension........................................59717 Technical correction...........................................60253 73.185 Added.......................................................41584 73.355 Added.......................................................41587 73.2995 Added......................................................48377 (c) corrected..................................................75158 74 Effective date confirmed........................................58221 74.3602 (b)(2)(i) revised; (b)(2)(iv) added........................46344 101 Technical correction...........................................11205 Stay of compliance.............................................58346 Compliance date established....................................69666 Authority citation revised.....................................76111 101.9 (b)(7)(vi) amended...........................................56479 101.17 Heading and (h) added; eff. 9-4-01..........................76111 101.71 (a), (c) and (e) removed; (b) and (d) redesignated as (a) and (b)....................................................58918 101.79 (c)(2)(i)(G) removed; (c)(2)(i)(H) redesignated as (c)(2)(i)(G)...............................................58918 101.83 Added.......................................................54717 (c)(2)(ii)(A)(2), (e)(1)(i), (ii), (2)(i) and (ii) corrected 70466 101.93 Heading revised; (f) and (g) added...........................1050 107.270 Amended....................................................56479 110.80 (a)(3) and (4) amended......................................56479 114.100 (a) amended................................................56479 115 Added; eff. 6-4-01.............................................76112 170.35 (c)(3) through (6) redesignated as (c)(4) through (7); new (c)(3) added...............................................51762 170.39 (h) amended.................................................56479 171.1 (a) and (c) amended; (n) added (effective date pending)......51763 171.100 (b) redesignated as (c); new (b) added.....................51763 172.120 (b)(1) table amended.......................................48378 172.135 (b)(1) table amended.......................................48379 172.841 (c) revised.........................................64605, 79719 172.846 (c)(9) added...............................................60859 173 Technical correction...........................................45522 173.300 (a) revised................................................34587 173.325 (c) revised.................................................1776 (b) revised....................................................16312 173.370 Added......................................................70660 175.105 (c)(5) table amended.................................8275, 20728 175.300 (b)(3)(viii)(b) amended....................................21312 (b)(3)(xxxiii) amended...................................6892, 37041 175.320 (b)(3) table amended.................................6892, 37041 176.170 (a)(5) table amended..................13678, 16520, 20728, 36786 (b)(2) table amended.....................................8275, 34081 176.180 (b)(2) table amended.......................................36787 176.300 (c) table amended...................................40497, 70789 177.1210 (b)(5) table 1 amended....................................26745 (b)(5) table amended...........................................52908 177.1211 (a) and (d) revised; (c) amended..........................16817 177.1360 (a)(3) and (d) revised....................................17135 177.1520 (a)(3)(vii) added; (c) table amended.......................3385 (a)(3)(i)(a)(4) added; (c) table amended.......................16313 177.2500 Added.....................................................15058 177.2600 (c)(4)(i) amended.........................................68890 178.2010 (b) table amended......15546, 16315, 26129, 26746, 38426, 41875 178.3295 Table amended.............................................16316 178.3725 Table amended.............................................52909 179.26 (b) table amended....................................45281, 64607 179.39 (a) and (b) table revised...................................71057 179 Technical correction...........................................76005 201 Compliance extension...........................................38191 201.66 (c)(5)(ii)(A) and (c)(5)(ii)(B) redesignated as (c)(5)(ii)(B) and (c)(5)(ii)(A); (d)(3) revised................8 201.66 (c)(5)(ii)(C) revised; eff. 5-16-02.....................46867 (c)(5)(ii)(C) revised; eff. 5-17-02............................48904 [[Page 339]] 201.314 (h)(1) revised.................................................8 201.323 Added; eff. 1-26-01.........................................4110 203 Hearing........................................................56480 203.3 Regulation at 64 FR 67757 effective delayed in part to 10- 01-01......................................................25639 203.50 Regulation at 64 FR 67761 effective date delayed to 10-01- 01.........................................................25639 205 Hearing........................................................56480 211.194 (a)(2) amended.............................................18889 310.500 (e) amended................................................56479 310.545 Regulation at 64 FR 27687 effective date delayed through 12-31-03...................................................36319 (d)(31) revised................................................36324 (a)(15)(ii) reinstated in part.................................48902 (a)(15) heading, (i) heading and (ii) revised; eff. 5-17-02....48905 (d)(2) correctly added; CFR correction.........................81739 312.3 (b) corrected; CFR correction................................81739 312.23 (a)(8) amended..............................................56479 312.42 (b)(1)(v) added; (b)(2)(i) revised..........................34971 312.145 Revised....................................................56479 314 Authority citation revised.....................................64617 Corrected; CFR correction..........................................81739 314.50 Introductory text amended...................................56479 314.70 (a) amended.................................................56479 314.81 (b)(2) introductory text and (vii) revised; (b)(2)(viii) and (ix) added.............................................64617 314.94 Introductory text amended...................................56479 314.105 (c) amended................................................56479 314.107 (e)(1) through (2)(iii) removed; (e)(2)(iv) redesignated as (e); new (e) heading revised; interim...................43235 314.420 (a)(1) removed; (a)(5) amended; eff. 7-10-00................1780 (c) amended....................................................56479 314.445 Revised....................................................56480 316.50 Revised.....................................................56480 330 Compliance date extention......................................38191 331 Compliance date extention......................................38191 333.250 (b)(1)(i) introductory text, (2)(i) introductory text and (ii) revised; eff. 5-16-02.................................52305 341 Compliance date extention......................................38191 341.74 (c)(4)(vi) revised..............................................8 (c)(5)(iii) through (vii) added; (d)(2)(i), (ii), (iv) and (v) revised; eff. 5-16-02..............................................46867 341.80 (c)(1)(ii)(D) revised...........................................8 344.3 (c) and (d) added; eff. 5-17-02..............................48905 344.10 Heading revised; eff. 5-17-02...............................48905 344.12 Added; eff. 5-17-02.........................................48905 344.50 Heading revised; (e) removed; eff. 5-17-02..................48905 344.52 Added; eff. 5-17-02.........................................48905 346 Compliance date extention......................................38191 349.75 (c)(2) revised; (c)(5) added; eff. 5-16-02..................38428 352 Regulation at 64 FR 27687 effective date delayed through 12- 31-03......................................................36319 355 Compliance date extention......................................38191 358 Compliance date extention......................................38191 369 Compliance date extention......................................38191 369.21 Amended.........................................................9 500.80 (a) amended.................................................56480 510 Effective date confirmation....................................17134 510.300 (a)(4) amended.............................................76929 510.600 (c)(1) table and (2) table amended....10705, 20729--20731, 25642, 36615, 36787, 45876, 54147, 55461, 60097, 60585, 69865 514.1 (d)(1)(ii) revised...........................................47669 (d)(2) amended.................................................56480 (b)(9) added...................................................76929 520.445b (d)(1)(i)(A)(2) amended...................................10706 520.1192 (a) and (b) revised; (c) redesignated as (d); new (c) added......................................................70661 520.1197 (d)(2) amended............................................45876 520.1263c (b) amended..............................................10705 520.1390 Added.....................................................20730 520.1485 (b) amended........................................45877, 53581 520.1510 Added.....................................................70662 520.1660d (b)(2), (d)(1)(ii)(A)(3), (B)(3), (C)(3) and (iii)(C) amended....................................................10705 520.1696b (b) amended..............................................10705 520.1720b (b) amended..............................................20731 520.2088 (c)(2) amended............................................10705 520.2089 (b) amended...............................................10705 520.2122 (b)(1) amended............................................45877 520.2325a (a)(3) amended...........................................10705 522.390 (b) amended................................................45877 522.460 (a)(2) and (b)(2) amended...................................6892 522.540 (d)(2)(i) and (e)(2) amended...............................45877 [[Page 340]] 522.778 (b) amended................................................45878 522.1044 (b)(4) amended............................................45877 522.1125 (d)(1) and (2) amended....................................20732 522.1183 (e)(1) amended............................................45877 522.1222a (c) amended..............................................45878 522.1244 (b) amended...............................................61090 522.1662a (i)(2) amended...........................................45877 522.1680 (b) amended...............................................45877 522.2120 (b) amended...............................................45877 522.2477 (b) revised; (d)(1) heading amended; (d)(1)(i)(C) added 10706 (b), (d)(1)(i)(A), (B), (C), (ii), (2)(i), (ii) and (3)(i) revised............................................................26748 (b) amended; (d)(1)(i)(D) added; (d)(2)(i) and (ii) revised....45879 (b) amended; (d)(3)(i) revised.................................70663 524.802 Added......................................................66620 524.1005 (b)(1) and (c)(3) revised; (c)(2)(iii) removed............41588 524.1376 (c)(2) amended............................................50913 524.1446 Added.....................................................13905 524.1451 (d)(2) and (3) amended....................................36617 524.2098 (d)(2) amended............................................45282 524.2481 (b) amended...............................................16817 526.365 (d)(3) amended.............................................20733 526.1810 Heading and (d)(3) amended................................61091 556.70 Revised.....................................................70791 556.275 Revised....................................................20733 (b)(1)(ii) and (3)(ii) added...................................41588 (b)(3) redesignated as (b)(4); new (b)(3) added................50914 556.426 Revised....................................................36617 (b) revised....................................................76930 556.515 Revised....................................................61091 556.570 Added.......................................................4112 556.592 Added......................................................70791 558.3 (b)(1)(ii) revised; (b)(6) through (11) added................76929 558.4 (d) table amended.............................................4112 558.6 Added........................................................76929 558.76 (d)(3)(xxii) added..........................................41589 (d)(3)(v) through (xvii) redesignated as (d)(3)(vi) through (xviii); new (d)(3)(v) added.......................................50134 (d)(3) revised.................................................50915 (d)(1) table amended...........................................54411 558.78 (d)(3) revised..............................................55894 (d)(3)(xxi) added..............................................11889 558.95 (d)(4)(ii) amended..........................................20734 (d)(5) introductory text and (i) through (iv) revised..........50134 (d)(5)(iii) and (iv) redesignated as (d)(5)(iv) and (v); new (d)(5)(iii) added..................................................53582 (a)(4) amended.................................................54148 558.128 (d)(1)(xii) table amended..................................45882 558.195 (d) table amended...................................66620, 82913 558.198 (d) revised................................................50134 558.258 (c) redesignated as (d); (d)(1)(vi) and (vii) added........41589 (d)(1) through (4) redesignated as (d)(2) through (5); new (d)(1) added.......................................................50914 558.265 (c)(1)(viii) and (3)(ii) added.............................45712 558.355 (d)(6), (f)(3)(x)(a) and (c) revised.......................45880 (f)(1)(xxviii), (2)(v) and (vi) added..........................53582 (f)(4)(ii) and (iii) redesignated as (f)(4)(i)(a) and (b); new (f)(4)(ii) and (iii) added.........................................53583 (f)(4)(iv) added...............................................54412 (f)(7) added...................................................82913 558.363 (a)(7) and (d)(1)(x) added.................................55894 (d)(1)(xi) added...............................................65271 558.364 (d) table amended..........................................45881 558.366 (c) table amended..........................................11889 558.460 (b) amended................................................45880 558.485 (a)(29) added..............................................66621 558.500 Added.......................................................4112 558.515 (c) and (d) revised........................................50915 558.530 (a) and (d)(5) revised; (d)(6) removed.....................45712 558.550 (a)(2), (d)(1)(xv)(c) and (xvi)(c) amended; (a)(3) removed; (d)(3)(i), (ii), and (iii) redesignated as (d)(3)(i)(A), (B) and (C); (d)(1)(xviii), (xix), new (3)(ii) and new (iii) added................................41876 (d)(3)(iv) added...............................................45523 (d)(3)(ii), (iii) and (iv) redesignated as (d)(3)(iv), (vi) and (vii); (a)(3), (d)(1)(xx), (xxi), new (3)(ii), (iii) and (v) added..............................................................70791 558.618 (d)(4) removed.............................................76930 558.625 (a) amended; (f)(2)(v)(e) redesignated as (f)(1)(vi)(e)....53582 (f)(2) revised.................................................65271 558.635 (d)(4) introductory text and (i) through (vii) revised.....50135 573.920 (b) revised; (h) added.....................................35824 (h) corrected..................................................53167 600.3 (hh) and (ii) added..........................................66634 Effective date corrected to May 7, 2001........................66634 600.14 Revised.....................................................66634 [[Page 341]] Effective date corrected to May 7, 2001........................66634 601 Authority citation revised.....................................64618 601.12 (Subpart B) Heading removed.................................59718 601.12 Transferred to Subpart C....................................59718 601.12--601.28 (Subpart C) Heading revised.........................59718 601.15 Redesignated from 601.28....................................59718 601.28 Redesignated as 601.15; new 601.28 added....................59718 (c) amended....................................................64618 601.29 Added.......................................................56480 601.70 Added.......................................................64618 606.3 (k) and (l) added............................................66635 Effective date corrected to May 7, 2001........................66634 606.160 (b)(7)(iii) revised........................................66635 Effective date corrected to May 7, 2001........................66635 606.171 Added......................................................66635 Effective date corrected to May 7, 2001........................66635 640 Effective date confirmation....................................13679 640.81 (e) amended; (f) revised.............................13679, 52018 640.92 (a) amended.................................................13679 640.102 (e) amended.........................................13679, 52018 660 Authority citation revised.....................................77499 660.20 (a) amended; eff. 6-11-01...................................77499 660.21 (a)(2) and (3) amended; eff. 6-11-01........................77499 660.50 (a) amended; eff. 6-11-01...................................77499 660.51 (a)(3) and (4) amended; eff. 6-11-01........................77499 700.35 Regulation at 64 FR 27693 effective date delayed through 12-31-03...................................................36319 701 Compliance date extention......................................38191 720 Heading revised................................................18889 801 Effective date confirmation....................................10012 801.126 Removed....................................................17136 801.410 (d)(2) amended; eff. 6-7-00.................................3586 (d)(2) amended.................................................44436 801.430 (f)(2) amended; footnote revised; eff. 6-7-00...............3586 (f)(2) amended; note revised...................................44436 (e)(1) table revised...........................................62284 803.1 (a) revised...................................................4118 803.3 (f) amended; (m) through (ee) redesignated as (n) through (ff); (c), new (p) introductory text, (1), (r) introductory text and (2) revised; (g) and new (m) added 4118 803.9 (c)(2) amended; (c)(3) removed; (c)(4) redesignated as (c)(3)......................................................4119 803.10 Heading and (a)(2) revised; (b) added........................4119 803.11 Amended......................................................4119 Revised........................................................17136 803.12 (b) revised..................................................4119 803.14 (b) amended.................................................56480 803.17 Introductory text amended....................................4119 803.18 Heading, (b)(1)(ii) and (2) revised; (a), (b)(1) introductory text and (c) amended; (d) added................4119 803.19 (b) and (c) amended..........................................4119 (f) and (g) removed............................................17136 803.20 (a) introductory text and (2) amended; (a)(1) revised; (b)(2) added................................................4119 803.22 (a), (b)(1) and (2) amended..................................4120 803.33 Heading revised; (a) introductory text, (1), (2), (5), (7) introductory text, (vi) and (c) amended.....................4120 803.40--803.42 (Subpart D) Added....................................4120 803.57 Removed......................................................4120 804 Removed.........................................................4120 807.65 (j) removed.................................................17136 807.90 (a)(1) and (2) revised......................................17137 808.51 Removed.....................................................66636 808.52 Removed.....................................................66636 808.94 Removed.....................................................66636 809.10 (f) added; eff. 4-9-01......................................18234 809.40 Added; eff. 4-9-01..........................................18234 811 Technical correction...........................................51532 812.19 Revised.....................................................17137 814.20 (g) and (h) revised.........................................17137 (g) revised....................................................56480 820.1 (e) and (f) removed..........................................17136 (e) added......................................................66636 821.50 (a) amended.................................................43690 860.3 (c)(2) amended...............................................56480 860.123 (b)(1) revised.............................................17137 862.9 Revised.......................................................2304 862.1030 (b) revised................................................2305 862.1040 (b) revised................................................2305 862.1060 (b) revised................................................2305 [[Page 342]] 862.1075 (b) revised................................................2305 862.1080 (b) revised................................................2305 862.1095 (b) revised................................................2305 862.1115 (b) revised................................................2305 862.1118 Added; eff. 4-28-00.......................................16521 862.1130 (b) revised................................................2305 862.1135 (b) revised................................................2305 862.1165 (b) revised................................................2305 862.1175 (b) revised................................................2305 862.1180 (b) revised................................................2305 862.1185 (b) revised................................................2305 862.1195 (b) revised................................................2305 862.1200 (b) revised................................................2305 862.1240 (b) revised................................................2305 862.1245 (b) revised................................................2306 862.1250 (b) revised................................................2306 862.1260 (b) revised................................................2306 862.1265 (b) revised................................................2306 862.1270 (b) revised................................................2306 862.1275 (b) revised................................................2306 862.1280 (b) revised................................................2306 862.1285 (b) revised................................................2306 862.1300 (b) revised................................................2306 862.1325 (b) revised................................................2306 862.1330 (b) revised................................................2306 862.1335 (b) revised................................................2306 862.1360 (b) revised................................................2306 862.1370 (b) revised................................................2306 862.1375 (b) revised................................................2306 862.1385 (b) revised................................................2306 862.1390 (b) revised................................................2306 862.1395 (b) revised................................................2306 862.1400 (b) revised................................................2306 862.1405 (b) revised................................................2306 862.1430 (b) revised................................................2307 862.1435 (b) revised................................................2307 862.1450 (b) revised................................................2307 862.1460 (b) revised................................................2307 862.1465 (b) revised................................................2307 862.1475 (b) revised................................................2307 862.1485 (b) revised................................................2307 862.1500 (b) revised................................................2307 862.1505 (b) revised................................................2307 862.1510 (b) revised................................................2307 862.1520 (b) revised................................................2307 862.1530 (b) revised................................................2307 862.1535 (b) revised................................................2307 862.1540 (b) revised................................................2307 862.1542 (b) revised................................................2307 862.1550 (b) revised................................................2307 862.1560 (b) revised................................................2307 862.1570 (b) revised................................................2307 862.1590 (b) revised................................................2307 862.1595 (b) revised................................................2308 862.1605 (b) revised................................................2308 862.1610 (b) revised................................................2308 862.1615 (b) revised................................................2308 862.1620 (b) revised................................................2308 862.1625 (b) revised................................................2308 862.1630 (b) revised................................................2308 862.1645 (b) revised................................................2308 862.1650 (b) revised................................................2308 862.1655 (b) revised................................................2308 862.1660 (b) revised................................................2308 862.1705 (b) revised................................................2308 862.1710 (b) revised...............................................62286 862.1725 (b) revised................................................2308 862.1780 (b) revised................................................2308 862.1785 (b) revised................................................2308 862.1790 (b) revised................................................2308 862.1795 (b) revised................................................2308 862.1805 (b) revised................................................2308 862.1820 (b) revised................................................2308 862.2140 (b) revised................................................2308 862.2150 (b) revised................................................2308 862.2160 (b) revised................................................2309 862.2170 (b) revised................................................2309 862.2250 (b) revised................................................2309 862.2260 (b) revised................................................2309 862.2270 (b) revised................................................2309 862.2300 (b) revised................................................2309 862.2400 (b) revised................................................2309 862.2500 (b) revised................................................2309 862.2540 (b) revised................................................2309 862.2560 (b) revised................................................2309 862.2680 (b) revised................................................2309 862.2700 (b) revised................................................2309 862.2730 (b) revised................................................2309 862.2750 (b) revised................................................2309 862.2850 (b) revised................................................2309 862.2860 (b) revised................................................2309 862.2900 (b) revised................................................2309 862.3280 (b) revised................................................2309 862.3750 (b) revised................................................2309 862.3850 (b) revised................................................2310 864.9 Revised.......................................................2310 864.2280 (b) revised................................................2310 864.3250 (b) revised................................................2310 (a) amended; eff. 4-9-01.......................................18234 864.3260 Added; eff. 4-9-01........................................18234 864.5240 (b) revised................................................2310 864.6150 (b) revised................................................2310 864.7250 (b) revised; (c) removed; eff. 5-1-00.....................17144 864.7300 (b) revised; (c) removed; eff. 5-1-00.....................17144 864.9125 (b) revised................................................2310 864.9185 (b) revised................................................2310 864.9195 (b) revised................................................2310 864.9225 (b) revised................................................2310 864.9275 (b) revised................................................2310 864.9320 (b) revised................................................2311 [[Page 343]] 864.9750 (b) revised................................................2311 866.9 Revised.......................................................2311 866.2660 (b) revised................................................2311 866.3040 (b) revised................................................2311 866.3140 (b) revised................................................2311 866.3145 (b) revised................................................2311 866.3200 (b) revised................................................2311 866.3240 (b) revised................................................2311 866.3355 (b) revised................................................2311 866.3360 (b) revised................................................2311 866.3375 (b) revised................................................2311 866.3380 (b) revised................................................2312 866.3405 (b) revised................................................2312 866.3480 (b) revised................................................2312 866.3500 (b) revised................................................2312 866.3510 (b) revised; (c) removed; eff. 5-1-00.....................17144 866.3600 (b) revised................................................2312 866.3680 (b) revised................................................2312 866.3740 (b) revised................................................2312 866.3850 (b) revised................................................2312 866.5060 (b) revised................................................2312 866.5065 (b) revised................................................2312 866.5160 (b) revised................................................2312 866.5200 (b) revised................................................2312 866.5330 (b) revised................................................2312 866.5400 (b) revised................................................2312 866.5420 (b) revised................................................2312 866.5425 (b) revised................................................2312 866.5430 (b) revised................................................2312 866.5440 (b) revised................................................2312 866.5560 (b) revised................................................2312 866.5570 (b) revised................................................2313 866.5590 (b) revised................................................2313 866.5715 (b) revised................................................2313 866.5735 (b) revised................................................2313 866.5765 (b) revised................................................2313 866.5785 Added.....................................................70307 866.5890 (b) revised................................................2313 868.9 Revised.......................................................2313 868.1910 (b) revised................................................2313 868.2380 Added; eff. 4-3-00........................................11465 868.2385 Added; eff. 4-3-00........................................11465 868.2450 (c) revised...............................................19834 868.5115 Added.....................................................39099 (b) corrected..................................................47670 868.5165 Added; eff. 4-3-00........................................11465 868.5620 (b) revised................................................2313 868.5640 (b) revised................................................2313 868.5675 (b) revised................................................2313 868.5700 (b) revised................................................2313 868.6810 (b) revised................................................2314 870.9 Revised.......................................................2314 870.3375 (b) revised; (c) removed; eff. 5-1-00.....................17144 870.3460 (b) revised...............................................11467 870.4200 Revised...................................................19319 870.5550 (b) revised; (c) removed; eff. 5-1-00.....................17144 872.9 Revised.......................................................2314 872.1745 Added.....................................................18235 872.3275 (a)(2) revised.............................................2314 872.3400 (b)(1) revised.............................................2315 872.3540 (b)(1) revised.............................................2315 (b)(2) revised; (c) removed; eff. 5-1-00.......................17144 872.3560 (b) revised; (c) removed; eff. 5-1-00.....................17144 872.3570 (b) revised; (c) removed; eff. 5-1-00.....................17144 872.3600 (b) revised; (c) removed; eff. 5-1-00.....................17144 872.3980 Added.....................................................60099 872.6080 (b) revised; (c) removed; eff. 5-1-00.....................17145 872.6300 Revised....................................................2315 872.6390 (b) revised................................................2315 872.6640 (b) revised................................................2315 874.9 Revised.......................................................2315 874.1070 (b) revised................................................2315 874.1100 (b) revised................................................2315 874.1500 (b) revised................................................2316 874.1800 (b) revised................................................2316 874.1925 (b) revised................................................2316 874.3300 (b) revised................................................2316 874.3400 (b) revised; (c) removed; eff. 5-1-00.....................17145 874.3540 (b) revised................................................2316 874.3930 (b) revised; (c) removed; eff. 5-1-00.....................17145 874.4100 (b) revised................................................2316 874.4420 (b) revised................................................2316 874.5300 (b) revised................................................2316 874.5550 (b) revised................................................2316 874.5840 (b) revised................................................2316 876.9 Revised.......................................................2316 876.3350 (c) revised...............................................19658 876.3630 Revised....................................................4882 876.4480 (b) revised; (c) removed; eff. 5-1-00.....................17145 876.5160 (b) revised................................................2317 876.5210 (b) revised................................................2317 876.5250 (b)(2) revised.............................................2317 876.5280 (c) revised...............................................57731 Regulation at 65 FR 57713 eff. date corrected to 9-26-00.......64618 876.5310 Added.....................................................18237 876.5860 Revised; eff. 5-1-00......................................17145 876.5955 (b) revised; (c) removed; eff. 5-1-00.....................17145 876.5980 (b)(2) revised.............................................2317 (b)(1) revised.................................................76932 [[Page 344]] 876.5990 Added.....................................................48612 878.9 Revised.......................................................2317 878.3250 (b) revised................................................2317 878.3610 Revised; eff. 5-1-00......................................17145 878.3720 Revised; eff. 5-1-00......................................17146 878.3910 (b) revised................................................2317 878.3925 (b) revised................................................2317 878.4040 (b) revised................................................2317 878.4100 (b) revised................................................2318 878.4200 (b) revised................................................2318 878.4320 (b) revised................................................2318 878.4495 Added.....................................................19836 878.4680 (b) revised................................................2318 878.4760 (b) revised................................................2318 878.4820 (b) revised................................................2318 878.4960 (b) revised................................................2318 878.5035 Added.....................................................20735 880.9 Revised.......................................................2318 880.5090 (b) revised................................................2318 880.5270 (b) revised................................................2318 880.5420 (b) revised................................................2319 880.5965 Added.....................................................37043 880.5970 Added.....................................................37043 880.6885 Added.....................................................36325 880.6890 Added.....................................................36326 882.9 Revised.......................................................2319 882.1200 (b) revised................................................2319 882.1500 (b) revised................................................2319 882.1750 (b) revised................................................2319 882.4060 (b) revised................................................2319 882.4545 (b) revised................................................2319 882.4650 (b) revised................................................2319 882.4750 (b) revised................................................2319 884.9 Revised.......................................................2319 884.1040 (b) revised................................................2320 884.1060 (b) revised; (c) removed; eff. 5-1-00.....................17146 884.1100 (b) revised; (c) removed; eff. 5-1-00.....................17146 884.1185 (b) revised; (c) removed; eff. 5-1-00.....................17146 884.2050 Revised...................................................41332 884.4100 (b) revised; (c) removed; eff. 5-1-00.....................17146 884.4150 (b) revised; (c) removed; eff. 5-1-00.....................17146 884.5330 Added.....................................................31455 884.5435 (b) amended................................................2320 884.5940 (c) revised...............................................19834 884.5970 Added.....................................................47306 886.9 Revised.......................................................2320 886.1350 (b) revised................................................2320 886.1780 (b) revised................................................2320 886.1940 (b) revised................................................2321 886.3400 Revised; eff. 5-1-00......................................17147 886.3920 Revised; eff. 5-1-00......................................17147 886.4070 (b) revised................................................2321 886.4300 (b) revised................................................2321 886.4392 Revised....................................................6894 886.4750 (b) revised................................................2321 886.5850 (b) revised................................................2321 888.9 Revised.......................................................2321 888.1500 Revised...................................................19319 888.3150 Revised; eff. 5-1-00......................................17147 888.3540 (b) revised; (c) removed; eff. 5-1-00.....................17147 888.3650 (b) revised; (c) removed; eff. 5-1-00.....................17148 888.3660 (b) revised; (c) removed; eff. 5-1-00.....................17148 890.9 Revised.......................................................2321 890.1175 (b) revised...............................................19319 890.3890 (c) revised...............................................19834 890.5180 (b) revised................................................2322 890.5710 (b) revised................................................2322 892.9 Revised.......................................................2322 892.1300 (b) revised................................................2322 892.1320 (b) revised................................................2322 892.1330 (b) revised................................................2322 892.1350 (b) revised................................................2322 892.1410 (b) revised................................................2322 892.1890 (b) revised................................................2323 892.1910 (b) revised................................................2323 892.1960 (b) revised................................................2323 892.1970 (b) revised................................................2323 892.2010 (b) revised................................................2323 892.2020 (b) revised................................................2323 892.5650 (b) revised................................................2323 892.6500 (b) revised................................................2323 895.21 (d)(8) amended..............................................43690 897 Removed........................................................17136 900.12 (e)(5)(iii)(A)(1) and (f)(3) amended........................43690 1005.25 (b) revised................................................17137 1010.4 (b) revised.................................................17137 1010.5 (c) revised.................................................17138 1020.30 (d)(1) revised.............................................17138 1040.10 (a)(3)(i) revised..........................................17138 1240.40--1240.57 (Subpart C) Removed...............................49908 1240.45 Transferred to Subpart B...................................49908 1270 Regulation at 63 FR 53585 confirmed...........................51538 1270.3 (f) revised.................................................51538 1270.5 (b) revised.................................................51538 1270.6 (c) added...................................................51538 1270.7 (c) through (f) redesignated as (d) through (g); new (c) added......................................................51538 Chapter II 1300.1 (b)(42) added...............................................44678 [[Page 345]] 1301 Technical correction..........................................17552 Supplementary statement........................................30541 1301.12 (b)(4) added...............................................44678 (b)(4) corrected...............................................45829 1301.72 (a) introductory text and (b) introductory text revised....13238 1301.77 Added......................................................44678 (c) corrected..................................................45829 1304 Technical correction..........................................49484 1304.03 (g) added..................................................44679 1306.11 (g) revised; interim.......................................45713 1307.12 Revised....................................................44679 (a) corrected..................................................45829 1308 Technical correction..........................................17552 1308.11 (e)(1) and (2) redesignated as (e)(2) and (3); new (e)(1) added......................................................13238 1308.12 (b)(1)(8) through (b)(1)(16) redesignated as (b)(1)(9) through (b)(1)(17); new (b)(1)(8) added....................69443 1308.13 (c)(5) through (11) redesignated as (c)(6) through (12); new (c)(5) added...........................................13238 Correction (c)(5) through (12) redesignated as (c)(6) through (13); new (c)(5) added.............................................17440 1308.34 Table amended; interim......................................3126 Table corrected.................................................5024 Regulation at 65 FR 3126 and 65 FR 5024 confirmed..............43694 1310 Technical correction..........................................48546 1310.02 (a)(24) added..............................................21647 (b)(8) revised; (b)(11) added..................................47316 1310.04 (f)(2)(ii)(H) and (I) added; (f)(2)(iv) revised............47316 1310.08 (a) and (b) introductory text revised; (f) through (i) added......................................................47316 1310.09 (c) added..................................................21647 [[Page 347]] Redesignation Table 1 At 53 FR 24668, June 29, 1988, 21 CFR part 193 was redesignated as 40 CFR part 185. The following table shows the relationship of the regulations under their assigned section numbers in 21 CFR part 193 prior to thispublication, and their redesignations as reflected in new 40 CFR part 185. ------------------------------------------------------------------------ Old section New section ------------------------------------------------------------------------ 193.10 185.100 193.15 185.150 193.20 185.200 193.25 185.250 193.30 185.350 193.40 185.500 193.43 185.600 193.45 185.650 193.50 185.700 193.60 185.750 193.65 185.1150 193.80 185.410 193.83 185.800 193.85 185.1000 193.90 185.1200 193.97 185.1300 193.98 185.1250 193.99 185.3300 193.100 185.1450 193.105 185.1500 193.130 185.1650 193.135 185.1700 193.137 185.1850 193.140 185.1900 193.142 185.1750 193.150 185.2225 193.151 185.2250 193.152 185.2150 193.156 185.2200 193.160 185.2500 193.170 185.2600 193.180 185.2650 193.186 185.2700 193.190 185.2750 193.200 185.2850 193.210 185.2900 193.212 185.3000 193.220 185.3450 193.225 185.3475 193.230 185.3480 193.235 185.3500 193.236 185.3550 193.240 185.3600 193.250 185.3700 193.251 185.425 193.253 185.3750 193.255 185.3800 193.260 185.3850 193.270 185.3900 193.275 185.3950 193.277 185.4000 193.280 185.4025 193.285. 185.4150 193.290 185.4200 193.300 185.4250 193.310 185.4300 193.320 185.4500 193.323 185.4400 193.324 185.4450 193.325 185.4600 193.330 185.4650 193.331 185.4700 193.340 185.4800 193.350 185.4850 193.360 185.4900 193.370 185.5000 193.375 185.5100 193.380 185.5150 193.390 185.5200 193.400 185.5350 193.410 185.1550 193.418 185.5450 193.420 185.5475 193.430 185.1350 193.440 185.5900 193.450 185.5750 193.460 185.6300 193.462 185.4550 193.463 185.2950 193.464 185.5300 193.465 185.1800 193.466 185.3250 193.467 185.3650 193.468 185.4950 193.470 185.5550 193.471 185.1050 193.472 185.1100 193.473 185.300 193.475 185.4100 193.476 185.5950 193.477 185.4350 193.479 185.2800 193.480 185.2275 193.481 185.5250 193.520 185.7000 ------------------------------------------------------------------------ [[Page 348]] Redesignation Table 2 At 53 FR 24666, June 29, 1988, 21 CFR part 561 was redesignated as 40 CFR part 186. The following redesignation table shows the relationship of the CFR section numbers formerly in 21 CFR part 561 and those sections being redesignated as 40 CFR part 186. ------------------------------------------------------------------------ Old section New section ------------------------------------------------------------------------ 561.20 186.100 561.30 186.150 561.40 186.200 561.41 186.250 561.50 186.350 561.51 186.375 561.53 186.4975 561.60 186.450 561.65 186.500 561.66 186.550 561.67 186.600 561.70 186.700 561.80 186.750 561.91 186.950 561.92 186.400 561.93 186.800 561.95 186.850 561.96 186.1250 561.97 186.1300 561.98 186.1000 561.99 186.1400 561.100 186.1450 561.110 186.1500 561.130 186.1600 561.140 186.1650 561.145 186.1700 561.150 186.1875 561.160 186.1950 561.170 186.2100 561.180 186.2225 561.190 186.2325 561.191 186.2150 561.197 186.2275 561.200 186.2400 561.210 186.2450 561.215 186.2500 561.220 186.2550 561.225 186.2700 561.230 186.2750 561.232 186.2950 561.233 186.3000 561.234 186.3050 561.235 186.2775 561.240 186.3350 561.250 186.3450 561.253 186.3500 561.255 186.3550 561.260 186.3700 561.263 186.3750 561.268 186.3800 561.270 186.3850 561.273 186.4000 561.280 186.4050 561.282 186.4150 561.283 186.4450 561.285 186.4575 561.289 186.4700 561.290 186.4750 561.300 186.4800 561.305 186.4850 561.310 186.4900 561.330 186.5000 561.340 186.5200 561.350 186.5350 561.360 186.1550 561.365 186.5400 561.380 186.5550 561.385 186.5600 561.386 186.5650 561.387 186.5700 561.390 186.5800 561.400 186.1350 561.410 186.6300 561.415 186.1750 561.420 186.2000 561.425 186.2050 561.427 186.1800 561.428 186.3250 561.429 186.3650 561.430 186.2800 561.432 186.4950 561.434 186.5100 561.435 186.3300 561.436 186.3400 561.437 186.1050 561.438 186.3200 561.439 186.1100 561.440 186.1850 561.441 186.300 561.442 186.5950 561.443 186.4350 561.444 186.5850 561.445 186.5250 ------------------------------------------------------------------------