12345 6 A B C I& E losses for the Humboldt Bay Facility, northern California Amy Gage, 11/ 25/ 02 Worksheets Contents QC Notes losses Losses data for the Humboldt Bay facility QC'd by M. Barron 11/ 27/ 02.

calculations I& E data from Humboldt Bay Power Plant Cooling Water Intake Structures 316( b)

Demonstration. Use this data! QC'd by M. Barron 11/ 27/ 02. Some minor changes made to species names.  A. Gage,

11/ 30/ 2002 Page 1 of 6 5 2343  readme 123456789 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 A B C D E F G H species stage year impinged. est entrained. est notes comments comments2 dummy dummy  9  9  9 dummy dummy dummy amphipod larvae 1980 0 1,800,393,863 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 yellow. shore. crab larvae 1980 0 995,073,973 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 amphipod larvae 1980 0 992,728,088 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 red. crab larvae 1980 0 433,654,264 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 ghost. shrimp larvae 1980 0 398,132,506 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 crab larvae 1980 0 386,739,343 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 anemone. shrimp larvae 1980 0 340,800,583 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 bony. fish eggs 1980 0 304,448,738 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 cumacean larvae 1980 0 217,044,393 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 amphipod larvae 1980 0 212,864,855 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 bay. shrimp larvae 1980 0 148,068,230 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 sea. spider larvae 1980 0 140,898,154 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 blue. mud. shrimp larvae 1980 0 95,845,793 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 lined. shore. crab larvae 1980 0 83,924,333 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 mud/ stone. crab larvae 1980 0 76,089,153 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 rock. crabs2 larvae 1980 0 57,705,608 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 arrow. worm larvae 1980 0 56,980,808 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 mysids larvae 1980 0 40,479,784 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 gastropod larvae 1980 0 33,849,371 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 herrings1 larvae 1980 0 33,452,325 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 skeleton. shrimp larvae 1980 0 29,160,354 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 amphipod larvae 1980 0 28,788,827 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 amphipod larvae 1980 0 26,422,304 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 mysids larvae 1980 0 23,835,877 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 gobies larvae 1980 0 23,419,364 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 crab larvae 1980 0 17,364,338 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 amphipod larvae 1980 0 16,416,642 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 protis. sp larvae 1980 0 11,439,350 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 amphipod larvae 1980 0 11,407,045 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 bivalve larvae 1980 0 11,282,058 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 bristleworm larvae 1980 0 10,302,106 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 pacific. sand. crab larvae 1980 0 7,430,099 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 amphipod larvae 1980 0 7,342,127 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 periwinkle eggs 1980 0 6,822,357 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 bony. fish larvae 1980 0 5,878,463 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 krill larvae 1980 0 5,371,692 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 tanaid larvae 1980 0 4,643,681 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 amphipod larvae 1980 0 4,312,347 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 sea. mussels larvae 1980 0 3,432,745 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 skeleton. shrimp larvae 1980 0 3,179,855 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 hermit. crab larvae 1980 0 3,045,583 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 porclain. crabs larvae 1980 0 2,962,643 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 isopod larvae 1980 0 2,689,416 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 mysids larvae 1980 0 2,640,939 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 jellyfish larvae 1980 0 2,615,836 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 smelts larvae 1980 0 2,551,907 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 tunicate. sea. squirt larvae 1980 0 2,422,551 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 isopod larvae 1980 0 1,797,851 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 malacostracan larvae 1980 0 1,771,959 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 amphipod larvae 1980 0 1,766,979 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 cumacean larvae 1980 0 1,693,480 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 amphipod larvae 1980 0 1,679,991 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 skeleton. shrimp larvae 1980 0 1,679,991 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 skeleton. shrimp larvae 1980 0 1,679,991 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 Page 2 of 6 5 2343  losses 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 A B C D E F G H amphipod larvae 1980 0 1,507,681 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 amphipod larvae 1980 0 1,320,470 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 chiton larvae 1980 0 1,297,720 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 boring. isopod larvae 1980 0 1,051,403 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 cumacean larvae 1980 0 922,565 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 pacific. sandlance larvae 1980 0 689,392 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 staghorn. sculpin larvae 1980 0 684,377 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 shrimp larvae 1980 0 659,311 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 amphipod larvae 1980 0 645,674 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 seaslug larvae 1980 0 645,674 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 spiders larvae 1980 0 645,674 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 worms larvae 1980 0 427,551 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 northern. anchovy eggs 1980 0 319,869 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 anchovies1 larvae 1980 0 312,628 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 northern. clingfish larvae 1980 0 181,504 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 prickly. sculpin larvae 1980 0 147,493 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 bay. pipefish larvae 1980 0 145,082 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 blackeye. goby larvae 1980 0 117,648 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 pricklebacks larvae 1980 0 90,537 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 copepod larvae 1980 0 80,675 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 sculpins larvae 1980 0 78,579 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 jacksmelt larvae 1980 0 41,688 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 bay. goby larvae 1980 0 29,004 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 surf. smelt larvae 1980 0 27,669 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 brown. irish. lord larvae 1980 0 26,805 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 clinids larvae 1980 0 24,522 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 northern. lampfish larvae 1980 0 24,478 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 buffalo. sculpin larvae 1980 0 13,791 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 gunnels larvae 1980 0 12,699 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 saddleback. gunnel larvae 1980 0 1,724 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 1 2 bay. pipefish age01 1980 819 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 bay. shrimp age01 1980 3150 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 blacktail. bay. shrimp age01 1980 2065 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 brittlestars age01 1980 494 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 dungeness1 age01 1980 1265 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 english. sole age01 1980 732 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 isopod age01 1980 1708 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 kellia age01 1980 484 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 nudibranch age01 1980 517 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 other. fish age01 1980 447 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 other. inverts age01 1980 4873 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 plumose. anemone age01 1980 36779 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 red. crab age01 1980 422 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 rock. crabs2 age01 1980 357 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 rockfish age01 1980 267 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 saddleback. gunnel age01 1980 141 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 seaslug age01 1980 1196 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 shiner. surfperch age01 1980 781 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 shrimp age01 1980 592 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 speckled. sanddab age01 1980 395 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 staghorn. sculpin age01 1980 120 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 threespine. stickleback age01 1980 2922 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 topsmelt age01 1980 158 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 tube. worms age01 1980 2197 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 tunicate. sea. squirt age01 1980 276 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 white. sea. cucumber age01 1980 3387 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 Page 3 of 6 5 2343  losses 113 114 115 A B C D E F G H white. surfperch age01 1980 79 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 worms age01 1980 978 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 yellow. shore. crab age01 1980 355 0 Humboldt Bay 316( b) Demonstration. Appendix E, Table E. 2 2 Page 4 of 6 5 2343  losses 123456789 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 A B C D E F G H I J K L species common. name stage year imp. 1 imp. 2 impinged. est entrain x 106 entrained. est notes comments comments2 bay. pipefish bay. pipefish age01 1980 306 513 819 na na Appendix E, Table E. 2 2 english. sole english. sole age01 1980 523 209 732 na na Appendix E, Table E. 2 2 sebastes. sp rockfish age01 1980 89 178 267 na na Appendix E, Table E. 2 2 shiner. surfperch shiner. surfperch age01 1980 475 306 781 na na Appendix E, Table E. 2 2 speckled. sanddab speckled. sanddab age01 1980 296 99 395 na na Appendix E, Table E. 2 2 staghorn. sculpin staghorn. sculpin age01 1980 120 . 120 na na Appendix E, Table E. 2 2 threespine. stickleback threespine. stickleback age01 1980 1206 1716 2922 na na Appendix E, Table E. 2 2 topsmelt topsmelt age01 1980 59 99 158 na na Appendix E, Table E. 2 2 white. surfperch white. surfperch age01 1980 79 . 79 na na Appendix E, Table E. 2 2 other. fish other. fish age01 1980 189 258 447 na na Appendix E, Table E. 2 2 saddleback. gunnel saddleback. gunnel age01 1980 . 141 141 na na Appendix E, Table E. 2 2 eupentacta. quinquesemita white. sea. cucumber age01 1980 983 2404 3387 na na Appendix E, Table E. 2 2 cancer. magister dungeness. crab age01 1980 733 532 1265 na na Appendix E, Table E. 2 2 cancer. productus red. crab age01 1980 422 na 422 na na Appendix E, Table E. 2 2 crangon. franciscorum bay. shrimp age01 1980 1435 1715 3150 na na Appendix E, Table E. 2 2 crangon. nigricauda blacktail. bay. shrimp age01 1980 761 1304 2065 na na Appendix E, Table E. 2 2 hemigrapsus. oregonensis yellow. shore. crab age01 1980 355 na 355 na na Appendix E, Table E. 2 2 kellia. laperous kellia age01 1980 484 na 484 na na Appendix E, Table E. 2 2 opisthobranchia seaslug age01 1980 398 798 1196 na na Appendix E, Table E. 2 2 gammaridae shrimp age01 1980 592 na 592 na na Appendix E, Table E. 2 2 idotea. resecata isopod age01 1980 718 990 1708 na na Appendix E, Table E. 2 2 halosydna. brevisetasa tube. worms age01 1980 564 1633 2197 na na Appendix E, Table E. 2 2 metridium. senile plumose. anemone age01 1980 24042 12737 36779 na na Appendix E, Table E. 2 2 nereidae worms age01 1980 406 572 978 na na Appendix E, Table E. 2 2 other. inverts other. inverts age01 1980 2030 2843 4873 na na Appendix E, Table E. 2 2 ascidiacea tunicate. sea. squirt age01 1980 na 276 276 na na Appendix E, Table E. 2 2 ophiuroidea brittlestars age01 1980 na 494 494 na na Appendix E, Table E. 2 2 cancer. antennarius rock. crab age01 1980 na 357 357 na na Appendix E, Table E. 2 2 archidoris. montereyensis nudibranch age01 1980 na 517 517 na na Appendix E, Table E. 2 2 bay. goby bay. goby larvae/ juv 1980 na na na 29,004 Appendix E, Table E. 1 2 bay. pipefish bay. pipefish larvae/ juv 1980 na na na 145,082 Appendix E, Table E. 1 2 blackeye. goby blackeye. goby larvae/ juv 1980 na na na 117,648 Appendix E, Table E. 1 2 brown. irish. lord brown. irish. lord larvae/ juv 1980 na na na 26,805 Appendix E, Table E. 1 2 buffalo. sculpin buffalo. sculpin larvae/ juv 1980 na na na 13,791 Appendix E, Table E. 1 2 clinidae clinids larvae/ juv 1980 na na na 24,522 Appendix E, Table E. 1 2 cottidae sculpins larvae/ juv 1980 na na na 78,579 Appendix E, Table E. 1 2 gobiidae gobies larvae/ juv 1980 na na na 23,419,364 Appendix E, Table E. 1 2 jacksmelt jacksmelt larvae/ juv 1980 na na na 41,688 Appendix E, Table E. 1 2 northern. anchovy northern. anchovy eggs 1980 na na na 319,869 Appendix E, Table E. 1 2 northern. anchovy northern. anchovy larvae/ juv 1980 na na na 312,628 Appendix E, Table E. 1 2 northern. clingfish northern. clingfish larvae/ juv 1980 na na na 181,504 Appendix E, Table E. 1 2 northern. lampfish northern. lampfish larvae/ juv 1980 na na na 24,478 Appendix E, Table E. 1 2 osmeridae smelts larvae/ juv 1980 na na na 2,551,907 Appendix E, Table E. 1 2 osteichthyes bony. fish eggs 1980 na na na 304,448,738 Appendix E, Table E. 1 2 osteichthyes bony. fish larvae/ juv 1980 na na na 5,878,463 Appendix E, Table E. 1 2 pacific. herring pacific. herring larvae/ juv 1980 na na na 33,452,325 Appendix E, Table E. 1 2 pacific. sandlance pacific. sandlance larvae/ juv 1980 na na na 689,392 Appendix E, Table E. 1 2 pholididae gunnels larvae/ juv 1980 na na na 12,699 Appendix E, Table E. 1 2 prickly. sculpin prickly. sculpin larvae/ juv 1980 na na na 147,493 Appendix E, Table E. 1 2 saddleback. gunnel saddleback. gunnel larvae/ juv 1980 na na na 1,724 Appendix E, Table E. 1 2 staghorn. sculpin staghorn. sculpin larvae/ juv 1980 na na na 684,377 Appendix E, Table E. 1 2 stichaeidae pricklebacks larvae/ juv 1980 na na na 90,537 Appendix E, Table E. 1 2 surf. smelt surf. smelt larvae/ juv 1980 na na na 27,669 Appendix E, Table E. 1 2 acanthomysis. macropsis mysids larvae/ juv 1980 na na na 40,479,784 Appendix E, Table E. 1 2 allorchestes. angusta amphipod larvae/ juv 1980 na na na 7,342,127 Appendix E, Table E. 1 2 araneae spiders larvae/ juv 1980 na na na 645,674 Appendix E, Table E. 1 2 archaeomysis. grebnitskii mysids larvae/ juv 1980 na na na 2,640,939 Appendix E, Table E. 1 2 ascidiacea tunicate. sea. squirt larvae/ juv 1980 na na na 2,422,551 Appendix E, Table E. 1 2 atylus. tridens amphipod larvae/ juv 1980 na na na 16,416,642 Appendix E, Table E. 1 2 bivalvia bivalve larvae/ juv 1980 na na na 11,282,058 Appendix E, Table E. 1 2 callianassa. sp ghost. shrimp larvae/ juv 1980 na na na 398,132,506 Appendix E, Table E. 1 2 cancer. productus red. crab larvae/ juv 1980 na na na 433,654,264 Appendix E, Table E. 1 2 cancer. sp rock. crab larvae/ juv 1980 na na na 57,705,608 Appendix E, Table E. 1 2 Page 5 of 6 5 2343  calculations 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 A B C D E F G H I J K L caprella. acanthogaster skeleton. shrimp larvae/ juv 1980 na na na 3,179,855 Appendix E, Table E. 1 2 caprella. californica skeleton. shrimp larvae/ juv 1980 na na na 1,679,991 Appendix E, Table E. 1 2 caprella. mutica skeleton. shrimp larvae/ juv 1980 na na na 1,679,991 Appendix E, Table E. 1 2 caprella. sp skeleton. shrimp larvae/ juv 1980 na na na 29,160,354 Appendix E, Table E. 1 2 corophium. acherusicum amphipod larvae/ juv 1980 na na na 212,864,855 Appendix E, Table E. 1 2 corophium. insidiosum amphipod larvae/ juv 1980 na na na 1,800,393,863 Appendix E, Table E. 1 2 corophium. sp amphipod larvae/ juv 1980 na na na 992,728,088 Appendix E, Table E. 1 2 corophium. spinicorni amphipod larvae/ juv 1980 na na na 1,679,991 Appendix E, Table E. 1 2 corophium. stimpsoni amphipod larvae/ juv 1980 na na na 28,788,827 Appendix E, Table E. 1 2 cragon. sp bay. shrimp larvae/ juv 1980 na na na 148,068,230 Appendix E, Table E. 1 2 cumella. vulgaris cumacean larvae/ juv 1980 na na na 217,044,393 Appendix E, Table E. 1 2 cyclopidae copepod larvae/ juv 1980 na na na 80,675 Appendix E, Table E. 1 2 emerita. analoga pacific. sand. crab larvae/ juv 1980 na na na 7,430,099 Appendix E, Table E. 1 2 epicaridea isopod larvae/ juv 1980 na na na 2,689,416 Appendix E, Table E. 1 2 euphausiacea krill larvae/ juv 1980 na na na 5,371,692 Appendix E, Table E. 1 2 gastropoda gastropod larvae/ juv 1980 na na na 33,849,371 Appendix E, Table E. 1 2 grandidierella. japonica amphipod larvae/ juv 1980 na na na 4,312,347 Appendix E, Table E. 1 2 hemigrapsus. oregonensis yellow. shore. crab larvae/ juv 1980 na na na 995,073,973 Appendix E, Table E. 1 2 hippolytidae anemone. shrimp larvae/ juv 1980 na na na 340,800,583 Appendix E, Table E. 1 2 hyale. sp amphipod larvae/ juv 1980 na na na 11,407,045 Appendix E, Table E. 1 2 hyperiidae amphipod larvae/ juv 1980 na na na 1,320,470 Appendix E, Table E. 1 2 jassa. falcata amphipod larvae/ juv 1980 na na na 26,422,304 Appendix E, Table E. 1 2 lamprops. sp cumacean larvae/ juv 1980 na na na 922,565 Appendix E, Table E. 1 2 leptochelia. dubia tanaid larvae/ juv 1980 na na na 4,643,681 Appendix E, Table E. 1 2 limnoria. sp boring. isopod larvae/ juv 1980 na na na 1,051,403 Appendix E, Table E. 1 2 littorina. scutulata periwinkle eggs 1980 na na na 6,822,357 Appendix E, Table E. 1 2 majidae crab larvae/ juv 1980 na na na 17,364,338 Appendix E, Table E. 1 2 melita. sp amphipod larvae/ juv 1980 na na na 1,507,681 Appendix E, Table E. 1 2 mesolamprops. dillonensis cumacean larvae/ juv 1980 na na na 1,693,480 Appendix E, Table E. 1 2 mopalia. sp chiton larvae/ juv 1980 na na na 1,297,720 Appendix E, Table E. 1 2 munnidae isopod larvae/ juv 1980 na na na 1,797,851 Appendix E, Table E. 1 2 mysidae mysids larvae/ juv 1980 na na na 23,835,877 Appendix E, Table E. 1 2 mytilidae sea. mussels larvae/ juv 1980 na na na 3,432,745 Appendix E, Table E. 1 2 nebalia. pugettensis malacostracan larvae/ juv 1980 na na na 1,771,959 Appendix E, Table E. 1 2 nereidae worms larvae/ juv 1980 na na na 427,551 Appendix E, Table E. 1 2 opisthobranchia seaslug larvae/ juv 1980 na na na 645,674 Appendix E, Table E. 1 2 pachygrapsus. crassipes lined. shore. crab larvae/ juv 1980 na na na 83,924,333 Appendix E, Table E. 1 2 pagurus. sp hermit. crab larvae/ juv 1980 na na na 3,045,583 Appendix E, Table E. 1 2 protis. sp protis. sp larvae/ juv 1980 na na na 11,439,350 Appendix E, Table E. 1 2 pimnotheridae crab larvae/ juv 1980 na na na 386,739,343 Appendix E, Table E. 1 2 podocerus. brasiliensis amphipod larvae/ juv 1980 na na na 645,674 Appendix E, Table E. 1 2 podocerus. cristatus amphipod larvae/ juv 1980 na na na 1,766,979 Appendix E, Table E. 1 2 polychaeta bristleworm larvae/ juv 1980 na na na 10,302,106 Appendix E, Table E. 1 2 polyorchis. sp jellyfish larvae/ juv 1980 na na na 2,615,836 Appendix E, Table E. 1 2 porcellanidae porclain. crabs larvae/ juv 1980 na na na 2,962,643 Appendix E, Table E. 1 2 pycnogonida sea. spider larvae/ juv 1980 na na na 140,898,154 Appendix E, Table E. 1 2 sagitta. sp arrow. worm larvae/ juv 1980 na na na 56,980,808 Appendix E, Table E. 1 2 sergestidae shrimp larvae/ juv 1980 na na na 659,311 Appendix E, Table E. 1 2 upogebia. pugettensis blue. mud. shrimp larvae/ juv 1980 na na na 95,845,793 Appendix E, Table E. 1 2 xanthidae mud/ stone. crab larvae/ juv 1980 na na na 76,089,153 Appendix E, Table E. 1 2 Page 6 of 6 5 2343  calculations


Comment Info: =================

General Comment:The attached files are the following docket-related documents:
?  U.S. DOT/FAA - Notice of proposed rulemaking supersedure
?  U.S. DOT/FAA - Notice of proposed rulemaking supersedure grid
?  U.S. DOT/FAA - Final rule supersedure
?  U.S. DOT/FAA - Final rule supersedure grid


[Federal Register Volume 84, Number 225 (Thursday, November 21, 2019)]
[Notices]
[Pages 64319-64321]
[FR Doc No: 2019-25246]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4447]

Transdermal and Topical Delivery Systems--Product Development and
Quality Considerations; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
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     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-4447 for ``Transdermal and Topical Delivery Systems--Product
Development and Quality Considerations.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Mohamed Ghorab, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3141, Silver Spring, MD 20993, 240-402-
8940.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Transdermal and Topical Delivery Systems--Product
Development and Quality Considerations.'' Transdermal delivery systems
and topical delivery systems, collectively identified as TDS, are used
in a variety of therapeutic areas and treatment populations.
Transdermal delivery systems are designed to deliver an active
ingredient (drug substance) across the skin and into systemic
circulation, while topical delivery systems are designed to deliver the
active ingredient to local tissue. Both transdermal delivery systems
and topical delivery systems present similar manufacturing and quality
control concerns and similar risks to patients.
    The draft guidance in its entirety may not be applicable to all
TDS, and some TDS (for example, microneedles, active transport TDS,
reservoir TDS, and TDS applied to broken skin) have other
considerations that are not addressed in this guidance. Because of the
inherent failure modes and safety risks associated with the reservoir
TDS, FDA recommends TDS manufacturers and applicants focus development
efforts on matrix type TDS.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on transdermal
and topical delivery systems product development and quality
considerations. It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
The collections of information in 21 CFR parts 210 and 211 have been
approved under OMB control number 0910-0139. The collections of
information in 21 CFR part 314 for the submission of NDAs and ANDAs,
including the submission of labeling under 21 CFR 314.50(e)(2)(ii) and
314.50(l)(1)(i) and advertisements and promotional labeling under 21
CFR 314.81(b)(3)(i), have been approved under OMB control number 0910-
0001. The submission of prescription drug labeling under 21 CFR 201.56
and 201.57 has been approved under OMB control number 0910-0572.
    In accordance with the PRA, prior to publication of any final
guidance document, FDA intends to solicit public comment and obtain OMB
approval for any information collections recommended in this guidance
that are new or that would represent material modifications to those
previously approved collections of information found in FDA regulations
or guidances.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/

GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: November 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25246 Filed 11-20-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 31, 2007 (Volume 72, Number 146)]
[Notices]
[Page 41741]
[DOCID:fr31jy07-75]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 405-074]

Susquehanna Electric Company and PECO Energy Power Company;
Notice of Temporary Variance Request and Soliciting Comments, Motions
To Intervene, and Protests

July 25, 2007.
    Take notice that the following hydroelectric application has been
filed with the Federal Energy Regulatory Commission (Commission) and is
available for public inspection:
    a. Type of Application: Request for Temporary Variance of Minimum
Flow Requirement.
    b. Project No.: 405-074.
    c. Date Filed: July 23, 2007.
    d. Applicant: Susquehanna Electric Company and PECO Energy Power
Company.
    e. Name of Project: Conowingo Project.
    f. Location: On the Susquehanna River, in Harford and Cecil
Counties, Maryland and York and Lancaster Counties, Pennsylvania. The
project does not utilize federal or tribal lands.
    g. Filed Pursuant to: 18 CFR 4.200.
    h. Applicant Contact: A. Karen Hill, Attorney for Exelon
Corporation, 101 Constitution Avenue, NW., Washington, DC 20001, (202)
347-7501.
    i. FERC Contact: Robert H. Grieve<EMAIL_ADDRESS>(202)
502-8752.
    j. Deadline for filing comments, motions to intervene and protest:
August 25, 2007.
    Please include the project number (P-405-074) on any comments or
motions filed. All documents (original and seven copies) should be
filed with: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426. Comments,
protests, and interventions may be filed electronically via the
Internet in lieu of paper, see 18 CFR 385.2001 (a)(1)(iii) and the
instructions on the Commission's Web site under the ``e-filing'' link.
The Commission strongly encourages electronic filings. Please include
the project number (P-405-074) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of any motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    k. Description of Request: Susquehanna Electric Company (SEC) and
PECO Energy Power Company (PECO) request Commission approval for a
variance of the minimum flow requirement of the project license. Due to
drought conditions and low river flows in the Susquehanna River, SEC
and PECO request that they be allowed immediately to include plant
leakage of about 800 cubic feet per second (cfs) in the required
minimum flow discharge until September 14, 2007, or until flow
conditions improve where the Conowingo Project no longer requires
leakage be included as part of the minimum flow requirement. According
to the license, for the period June 1 through September 14, annually,
SEC and PECO must provide a minimum flow release (not including
leakage) below the dam of 5,000 cfs, or inflow (as measured at the USGS
gage at Marietta, PA), whichever is less. During the fall period,
September 15 through November 30, SEC and PECO are required to release
a minimum flow of 3,500 cfs not including leakage, or inflow to the
project whichever is less, as measured at the Marietta gage.
    The SEC and PECO are concerned about the ability of the Conowingo
Project to maintain an adequate pond level and storage capacity during
the current low flow period. Maintaining storage is necessary for
generation and to ensure an adequate water supply for recreational and
consumptive uses of the Conowingo Reservoir to include operation of
Peach Bottom Atomic Power Station and Muddy Run Pumped Storage Project.
Including plant leakage in the minimum flow discharge will contribute
to the maintenance of these project water uses during this low flow
period. During the period of the minimum flow variance, SEC and PECO
will conduct daily monitoring of the Susquehanna River below the
project for potential environmental effects. If any abnormal or adverse
conditions are observed, SEC and PECO will promptly notify the Maryland
Department of Natural Resources.
    l. Locations of the Application: Copies of this filing are on file
with the Commission and are available for public inspection and
reproduction at the Commission's Public Reference Room, located at 888
First St., NE, Room 2A, Washington, DC 20426. This filing may be viewed
on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to

be notified via e-mail of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>or for TTY<PHONE_NUMBER>. A copy is also

available for inspection and reproduction at the address in item (h)
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210.
385.211, and 385.214. In determining the appropriate action to take,
the Commission will consider all protests filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any protests or motions to
intervene must be received on or before the specified deadline date for
the particular application.
    o. Any filings must bear in all capital letters the title
``COMMENTS'', ``PROTEST'', or MOTION TO INTERVENE'', as applicable, and
the Project Number of the particular application to which the filing
refers.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. Comments, protests, and interventions may be filed
electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
at http://www.ferc.gov under the ``e-filing'' link.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-14798 Filed 7-30-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: September 8, 2010 (Volume 75, Number 173)]
[Rules and Regulations]
[Page 54497]
[DOCID:fr08se10-10]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[EPA-R03-OAR-2010-0431; FRL-9197-5]

Approval and Promulgation of Air Quality Implementation Plans;
Maryland; Withdrawal of Direct Final Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of direct final rule.

-----------------------------------------------------------------------

SUMMARY: Due to an adverse comment, EPA is withdrawing the direct final
rule to extend the attainment date from June 15, 2010 to June 15, 2011
for the Baltimore nonattainment area, which is classified as moderate
for the 1997 8-hour ozone national ambient air quality standard
(NAAQS). In the direct final rule published on July 23, 2010, we stated
that if we received any adverse comments by August 23, 2010, the rule
would be withdrawn and would not take effect. EPA received an adverse
comment within the comment period. EPA will address the comment
received in a subsequent final action based upon the proposed action
also published on July 23, 2010 (75 FR 43114). EPA will not institute a
second comment period on this action.

DATES: Effective Date: The direct final rule is withdrawn as of
September 8, 2010.

FOR FURTHER INFORMATION CONTACT: Gregory Becoat,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: August 18, 2010.
Shawn M. Garvin,
Regional Administrator, Region III.

0
Accordingly, the amendments to Sec.  81.321, published in the direct
final rule on July 23, 2010 (75 FR 43069), are withdrawn as of
September 8, 2010.

[FR Doc. 2010-22344 Filed 9-7-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Notices]
[Pages 51025-51026]
[FR Doc No: 2011-20895]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Project No. 14208-000]

 Percheron Power, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On May 31, 2011, Percheron Power, LLC filed an application for a

preliminary permit, pursuant to section 4(f) of the Federal Power Act
(FPA), proposing to study the feasibility of the Potholes East Canal
Water Power Project (East Canal Project or project) to be located on
the Potholes East Canal, near Othello, Franklin County, Washington. The
sole purpose of a preliminary permit, if issued, is to grant the permit
holder priority to file a license application during the permit term. A
preliminary permit does not authorize the permit holder to perform any
land-disturbing activities or otherwise enter upon lands or waters
owned by others without the owners' express permission.
    The proposed project would consist of the following: (1) An
approximately 400-foot-long intake structure installed on the Potholes
East Canal to divert flow from the canal to the turbines, which would
be 120 feet wide at the intersection with the canal and would narrow to
75 feet wide before entering the powerhouse, and would include a 120-
foot-wide, 15-foot-high intake grate and a 75-foot-wide, 15-foot-high
trash rack; (2) an approximately 100-foot-long, 20-foot-wide powerhouse
containing five low-head turbine/generator units rated for
approximately 400 kilowatts each (total capacity of 2,020 kilowatts) at
an average head of 18 feet; (3) a 600-foot-long, 11-foot-high bypass
weir, constructed in parallel to the west bank of the existing Potholes
East Canal, to function as a project spillway; (4) a discharge canal
returning flows from the powerhouse to the Potholes East Canal; (5) a
20-foot-long, 50-foot-wide substation at the powerhouse which will
connect with the existing distribution line at the project site; and
(6) appurtenant facilities. The project will be located on federal
lands, and would operate as run-of-release using irrigation flows
provided by the Bureau of Reclamation and the South Columbia Basin
Irrigation District. The estimated annual generation of the Scooteney
Outlet Project would be 5.44 gigawatt-hours.
    Applicant Contact: Mr. Jerry Straalsund, President, Percheron
Power, LLC, 6855 W. Clearwater Ave., A101-260, Kennewick, WA 99336; e-
mail<EMAIL_ADDRESS>    FERC Contact: Jennifer Harper; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14208-000) in the docket number field to
access the document. For assistance, contact FERC Online Support.

    Dated: August 10, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-20895 Filed 8-16-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 222 (Thursday, November 17, 2011)]
[Proposed Rules]
[Pages 71281-71286]
[FR Doc No: 2011-29702]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1140

[Docket No. FDA-2011-N-0493]

RIN 0910-AG40

Regulations Restricting the Sale and Distribution of Cigarettes
and Smokeless Tobacco To Protect Children and Adolescents

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the Agency's regulations to allow the manufacturer of a cigarette or
smokeless tobacco product with a trade or brand name that is also the
trade or brand name of a nontobacco product to continue to use the name
if the tobacco product was sold in the United States on or before June
22, 2009. FDA further proposes to amend the Agency's regulations to
ensure that a manufacturer of a cigarette or smokeless tobacco product
may continue to use its trade or brand name even if that name is
subsequently registered with the United States Patent and Trademark
Office (USPTO) or subsequently used for a nontobacco product.

DATES: Submit either electronic or written comments by January 31,
2012.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0493 and/or RIN 0910-AG40 by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency
name, Docket No. FDA-2011-N-0493, and RIN 0910-AG40, for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Gail Schmerfeld, Center for Tobacco
Products, 9200 Corporate Blvd., Rockville, MD 20850-3229, 1-(877) 287-
1373<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control
Act) into law. The Tobacco Control Act amended the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.) by adding a new
chapter granting FDA important new authority to regulate the
manufacture, marketing, and distribution of tobacco products to protect
public health generally and to reduce tobacco use by minors.
    Section 102 of the Tobacco Control Act required FDA to publish a
final rule regarding cigarettes and smokeless tobacco identical in its
provisions to the ``Regulations Restricting the Sale and Distribution
of Cigarettes and Smokeless Tobacco to Protect Children and
Adolescents'' (61 FR 44396, August 28, 1996) (1996 final rule), with
certain specified exceptions. None of the specified exceptions affect
the substance of Sec.  897.16(a) (21 CFR 897.16(a)) of the 1996 final
rule. Thus, Sec.  1140.16(a) (21 CFR 1140.16(a)) in the reissued 1996
final rule is identical to Sec.  897.16(a) of the 1996 final rule:
``Restriction on product names. A manufacturer shall not use a trade or
brand name of a nontobacco product as the trade or brand name for a
cigarette or smokeless tobacco product, except for a tobacco product
whose trade or brand name was on both a tobacco product and a
nontobacco product that were sold in the United States on January 1,
1995.''
    This provision, like other provisions in the 1996 final rule, was
intended to ensure that the restrictions on sale and distribution to
children and adolescents were not undermined by how the product was
presented to the public (61 FR 44396 at 44444). If a manufacturer was
permitted to use a popular nontobacco product trade name and put it on
a tobacco product, the manufacturer could attempt to exploit the
imagery or consumer identification attached to the nontobacco product
to make the tobacco product appeal to young people (Id.).
    FDA included the January 1, 1995, date in Sec.  897.16(a) of the
1996 final rule so that the restriction would not apply to cigarette
and smokeless tobacco products that already were using trade or brand
names that were also on nontobacco product (60 FR 41314 at 41324
(August 11, 1995), 61 FR 44396 at 44444)). FDA's intent was to
prospectively prohibit tobacco manufacturers from using nontobacco
trade or brand names, whether used on tangible products or for
services, on cigarettes and smokeless tobacco products (Id.).\1\ Thus,
the section permitted manufacturers to continue using a nontobacco
trade or brand name for its cigarettes or smokeless tobacco product if
the name was on both a tobacco product and a nontobacco product sold in
the United States on or before January 1, 1995 (61 FR 44396 at 44444).
---------------------------------------------------------------------------

    \1\ FDA intended to construe this grandfather exception narrowly
such that, if the trade or brand name of a pre-existing nontobacco
product was ``Old Time Country Store,'' the grandfather exception
would not apply to a cigarette product called ``Old Time'' because
``Old Time'' was not identical to the name of the pre-existing
nontobacco product (61 FR 44396 at 44445).
---------------------------------------------------------------------------

    FDA also intended that this provision of the 1996 final rule would
apply only to trade names in use in the United States (61 FR 44396 at
44445). In the preamble to the 1996 final rule, FDA acknowledged that
it would be unreasonable for the regulations to encompass all possible
nontobacco product trade names, regardless of their nationality or
whether the trade name was a registered trademark. Neither FDA nor
manufacturers would be able to ensure that the name was not used
outside the United States.
    FDA is proposing to amend Sec.  1140.16(a) to change the
grandfather date from January 1, 1995, to June 22, 2009, in recognition
of the fact that 14 years elapsed since the publication of the 1996
final rule. Using the January 1995 date significantly changes Sec.
1140.16(a), from a provision that was intended to apply prospectively
to one that applies retroactively. The proposed rule would amend the
section to allow cigarettes and smokeless tobacco products sold in the
United States on or before June 22, 2009, to continue to be sold under
their trade or brand name, even if the trade or brand name was also

used for a nontobacco product sold during that time. Thus, the proposed
amendment would restore the FDA's original intention that the
restriction apply prospectively only.
    FDA is also proposing to amend Sec.  1140.16(a) to ensure that a
manufacturer may continue to use the trade or brand name of its
cigarette or smokeless tobacco product if the trade or brand name is
later registered with the USPTO or used on a nontobacco product.\2\
Thus, a tobacco manufacturer would not be required to monitor whether a
trade or brand name is registered for a nontobacco product after it
initiates the sale of its tobacco product under a particular trade or
brand name. In order to ensure that tobacco companies can comply with,
and FDA can enforce, the proposed restriction, the proposed amendment
would make explicit that the prohibition on the use of a nontobacco
trade or brand name turns on whether such name is ``registered,'' that
is, whether it is listed in the USPTO's registration listing. FDA
believes that this proposed change is consistent with the intent of the
provision as originally issued in 1996 to prevent tobacco product
manufacturers from exploiting the imagery and consumer identification
associated with the trade or brand name of a nontobacco product. Thus,
the provision should apply to situations where the use of the trade or
brand name on the nontobacco product precedes the sale of a tobacco
product with the same trade or brand name and should not restrict trade
or brand names of tobacco products in other situations.
---------------------------------------------------------------------------

    \2\ USPTO registers trade or brand names for both goods and
services.
---------------------------------------------------------------------------

    In addition, FDA is proposing to amend Sec.  1140.16(a) to permit
manufacturers to request an exemption from the restriction based on
information that adequately demonstrates that their proposed trade or
brand name does not substantially appeal to children or adolescents.
The goal of the restriction is to ensure that manufacturers cannot
exploit the imagery or consumer identification attached to the
nontobacco product to make the tobacco product appeal to young people.
If the manufacturer demonstrates in a written submission to the
Director of FDA's Center for Tobacco Products that the proposed name
(e.g., through the associated imagery or consumer identification
attached to the nontobacco product) does not have substantial appeal to
young people, then the potential for such exploitation is unlikely and
the request for an exception would be granted.
    As originally proposed, and as amended, the restriction on product
names is intended to limit the sales and distribution of cigarettes and
smokeless tobacco to children and adolescents. The State's interest in
preventing the use of tobacco products by minors is well established.
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 161 (2000)
(``[FDA] has amply demonstrated that tobacco use, particularly among
children and adolescents, poses perhaps the single most significant
threat to public health in the United States.''); Lorillard Tobacco Co.
v. Reilly, 533 U.S. 525, 564 (2001) (``The State's interest in
preventing underage tobacco use is substantial, and even
compelling.''). The proposed restriction on the use of nontobacco
product names provides a reasonable means to effect the goal of
preventing the use of tobacco in minors.
    Tobacco use continues to be the single leading preventable cause of
death and disease in the United States (Ref. 1). More than 80 percent
of established adult smokers begin smoking before age 18 years (Ref. 1)
and, of those adolescents who continue to smoke regularly,
approximately 50 percent will die from smoking-attributable disease
(Ref. 2). Among children, data from the 2009 Youth Risk Behavior
Survey, a nationally representative survey of students in grades 9
through 12 in the United States, showed that almost half (46.3 percent)
of U.S. high school students had tried cigarette smoking, and an
estimated 19.5 percent of students were current cigarette smokers (Ref.
3). Overall, approximately 7.3 percent of high school students in 2009
were frequent cigarette users, and 11.2 percent of students under the
age of 18 had been daily smokers at some point during their lifetime.
Furthermore, followup studies of youth smokers have indicated that a
significant number of students who are light smokers (i.e., students
who are not daily smokers or who smoke less than 10 cigarettes per day)
in high school will become heavy smokers after leaving high school
(Ref. 4). In 2009, nearly 9 percent of high school students used a
smokeless tobacco product (e.g., chewing tobacco, snuff, or dip) (Ref.
5). The Surgeon General reports that adolescents who use smokeless
tobacco are more likely than nonusers to become cigarette smokers (Ref.
5).
    Research supports the conclusion that tobacco advertising and
promotion contribute to youth smoking initiation (Refs. 6 at p. 131, 7,
8, 9, and 10). The cigarette industry spends billions of dollars on
advertising and promotion each year (Ref. 11). The National Cancer
Institute (NCI) Monograph 19 stated that ``tobacco advertising forms
part of an integrated marketing communications strategy combining
sponsorship, brand merchandising, brand stretching, packaging, point-
of-sale promotions, and product placement'' (Ref. 12 at p. 7). With
respect to marketing tobacco to children and adolescents, Monograph 19
concluded among other things, that: (1) Tobacco advertising targets the
psychological needs of adolescents (e.g., popularity) and ``adolescents
who believe that smoking can satisfy their psychological needs, or
whose desired image of themselves is similar to their image of smokers,
are more likely to smoke cigarettes'' and (2) even brief exposure to
tobacco advertising influences adolescents' intentions to smoke (Ref.
12 at pp. 280 and 281).
    Brand equity, which consists of company name, brand, symbols, and
slogans, and their underlying associations, is a primary source of
competitive advantage and future earnings (Ref. 13). Researchers have
found that by the time children reach 11 or 12 years of age, they are
decoding consumption symbols based on brand names, forming impressions
of product owners based on the image and meanings of the brand name
identified with the product (Ref. 14).
    As new marketing restrictions under the reissued final rule go into
effect, the incentive to use other means such as brand name extension
increases. Experience shows that, when faced with restrictions on
marketing and advertising, tobacco firms shift their promotional
efforts away from restricted practices and into a different mix of
activities that are permissible (Ref. 15).
    In light of the new regulations restricting the sale and
distribution of cigarettes and smokeless tobacco products, one possible
way for a tobacco company to attempt to gain immediate cachet with the
youth market would be to purchase or license the name of a nontobacco
product that has already established brand equity with youth. As FDA
explained in issuing the original version of the rule, the restriction
on the use of a nontobacco brand name sought to limit the elements of
marketing and advertising ``that resonate most strongly with the needs
of those under 18 to establish an appropriate image and to create a
sense of acceptance and belonging.'' 61 FR 44396 at 44444 (1996). For
example, the name of a popular motorcycle or cosmetic brand, if used on
a tobacco product, may create immediate interest and appeal in the
youth market. This would allow the tobacco companies to again
capitalize on the susceptibility of this age group to

certain advertising and marketing practices, and to the appeal of
brands in particular. Accordingly, the proposed restriction on the use
of nontobacco product names is one means of preventing tobacco
companies from circumventing the sale and distribution restrictions
implemented in the reissued 1996 final rule.
    As amended, the brand name provision permits tobacco products sold
on or before the June 22, 2009, the date of enactment of the Tobacco
Control Act, to continue to be marketed with their current brand name.
This change in date restores the prospective intent of the 1996
provision. Further, neither the reissued 1996 final rule, nor the
proposed amendment, would affect any aspect of marketing; the only
effect of the proposed rule change would be to allow some additional
brand names that are not allowed under the reissued 1996 final rule.
Finally, requiring companies, when introducing new tobacco products, to
research other uses of the same brand name is reasonable and does not
significantly affect the way companies can introduce new tobacco
products.
    In addition, by amending the rule to allow tobacco companies to
continue to use the trade or brand name of its cigarette or smokeless
tobacco product after that brand name is later registered by another
company with the USPTO or used on a nontobacco product, FDA seeks to
prevent companies who manufacture products other than tobacco from
unfairly exploiting the rule to the detriment of tobacco companies.
Accordingly, once a tobacco product is introduced to the market under a
particular brand name, the subsequent introduction of a nontobacco
product under the same name, or the registration of that brand name for
a nontobacco product, would not make the continued marketing of the
tobacco product under the same brand name a violation of this rule.
    Furthermore, by amending the rule to allow manufacturers to seek an
exemption from the restriction upon a demonstration that the proposed
name does not have substantial appeal to children or adolescents, FDA
seeks to target the restriction to achieve the specific intended goal.

II. Legal Authority

    FDA's authority to issue this proposed rule is provided by section
102 of the Tobacco Control Act. Sections 102(a)(3) and (a)(4) provide
that FDA may amend the reissued 1996 final rule in accordance with the
Administrative Procedure Act requirements for notice and comment
rulemaking (chapter 5 of title 5 of the United States Code). In
addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) gives FDA
general rulemaking authority to issue regulations for the efficient
enforcement of the FD&C Act.

III. FDA Enforcement of the Brand Name Provision

    On May 7, 2010, FDA announced the availability of the guidance
entitled ``Enforcement Policy Concerning Certain Regulations
Restricting the Sale and Distribution of Cigarettes and Smokeless
Tobacco'' (75 FR 25271, May 7, 2010). Persons with access to the
Internet may obtain an electronic version of that guidance document at
either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
FDA issued the guidance in part because it was aware of concerns
regarding Sec.  1140.16(a). The guidance discusses FDA's enforcement
discretion policy concerning Sec.  1140.16(a) while it considers what
changes to the section, if any, would be appropriate to address those
concerns. Specifically, the guidance provides that FDA intends to
exercise its enforcement discretion concerning Sec.  1140.16(a) not to
commence enforcement actions under this provision where: (1) The trade
or brand name of the cigarettes or smokeless tobacco product was
registered, or the product was marketed, in the United States on or
before June 22, 2009; or (2) The first marketing or registration in the
United States of the tobacco product occurs before the first marketing
or registration in the United States of the nontobacco product bearing
the same name; provided, however, that the tobacco and nontobacco
product are not owned, manufactured, or distributed by the same,
related, or affiliated entities including as a licensee.

IV. Environmental Impact

    FDA has carefully considered the potential environmental impacts of
this rule and determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

V. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule is not a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the proposed rule would not impose any
direct or indirect costs on industry or government, but rather would
only change the date on which products were exempted from complying
with the brand name prohibition in the reissued 1996 final rule and
ensure that cigarette and smokeless tobacco brands may continue to use
a trade or brand name that is subsequently used, or subsequently
registered for use, on a nontobacco product, the Agency proposes to
certify that the rule would not have a significant economic impact on a
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

A. Affected Products

    FDA has identified 17 cigarette and smokeless tobacco products that
are out of compliance with Sec.  1140.16(a) of the reissued 1996 final
rule, which became effective on June 22, 2010, but that would be in
compliance under the proposed amendment. These products were introduced
between January 1, 1995 (the date when products were grandfathered in
under the 1996 final rule), and June 22, 2009 (the grandfather date set
forth in this proposed amendment), and they share names with nontobacco
products presently

registered with the USPTO.\3\ The 17 product names appear in table 1 of
this Federal Register document.\4\

                                                     Table 1--Products Affected by the Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 Year of
   Cigarette or smokeless tobacco brand       introduction                         Examples of nontobacco products with same name**
--------------------------------------------------------------------------------------------------------------------------------------------------------
Complete..................................              2004  Golf Balls, Disposable Adult Briefs and Underwear.
Eclipse...................................              1996  Insect Traps, Oxygen Concentrators for Medical Use.
Exact.....................................              2001  Ink and Toner, Medical and Surgical Instruments.
Exalt*....................................              2001  Display Racks, Cattle Vaccines.
Grand Prix*...............................              2008  Apparel for Horseback Riding, Car Wash Services.
Kayak*....................................              1999  Internet Travel Services, Protective Swimming Pool Liners.
King's....................................              1995  All-Purpose Flour, Safety Apparatus.
Lone Star.................................              2002  Welding Machines, Beer.
Longhorn*.................................              2003  Investment and Financial Services, Apparel.
Premis....................................              2004  Integrated Circuits, Hospital Accounting Software.
Pro*......................................              2008  Bicycles and Bicycle Accessories, Fireworks.
Quest.....................................              2003  Software, Snowboards.
Revel*....................................              2001  Loudspeakers, Bedding and Bathroom Accessories.
Roger.....................................              1999  Apparel, Pilot Training Services.
Stonewall*................................              2001  Concrete Blocks for Retaining Walls, Turf and Herbicide.
Tahoe.....................................              2000  Cookies, Hearth and Fireplace Products.
Thunder...................................              2009  Earmuffs, Potato Chips.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Smokeless Tobacco Product.
** List is not exhaustive.
Sources: Refs. 16 through 22.

    Table 1 includes 10 cigarette brands. Data from the 2005 National
Survey on Drug Use and Health (NSDUH) indicate that each of the 9
cigarette brands in this list that had been introduced by 2005 was the
usual cigarette choice for less than (probably significantly less than)
1.9 percent of smokers (Ref. 23).\5\ Results from the 2008 Maxwell
Reports, the primary private source of cigarette sales data, are
consistent with those from the NSDUH (Ref 24).\6\ There are no reported
data indicating that any of the brands listed in table 1 are brands
popular with youth. Several sources agree that the most popular brands
among youth are Marlboro, Newport, and Camel (Refs. 23 and 25).
---------------------------------------------------------------------------

    \3\ Registrations were current as of September 22, 2010.
    \4\ There are additional tobacco products that share names with
nontobacco products whose names are not registered with the USPTO.
    \5\ NSDUH is a large, nationally representative survey conducted
by the Substance Abuse and Mental Health Services Administration
(SAMHSA). While its primary purpose relates to drug use in the
United States, it also provides information regarding cigarette use.
Individuals aged 12 and above who had smoked within the past month
were asked about their usual brand choice during that time period.
The data indicate that the top 10 brands account for the usual
choice of over 80 percent of respondents, with shares ranging from
42.4 percent for Marlboro to 1.9 percent for Salem and USA Gold.
None of the brands listed in table 1 appears in the list of top 10
brands. Accordingly, the shares must be less than 1.9 percent, and
we believe that the shares are likely substantially less than that
given the brands' relative obscurity.
    \6\ Maxwell lists 2008's 14 highest-selling cigarette brands,
the smallest of which (Misty) had a 1.4 percent market share (4.87
billion units sold). Since none of the brands appearing in table 1
are among the top 14 ranked by Maxwell, each would have had a market
share no higher than 1.4 percent.
---------------------------------------------------------------------------

    Table 1 includes seven smokeless tobacco brands. Five of them were
introduced before 2005. The 2005 NSDUH identifies the 15 brands used
most often by past-month smokeless tobacco users (Ref. 26). The only
brand from table 1, among the five introduced prior to 2005, reported
separately in the NSDUH data is Longhorn, which had an overall share of
0.7 percent. Among persons aged 12 to 17, it had a share of only 0.4
percent. The remaining brand shares were too small to be reported
individually.

B. Benefits of the Proposed Rule

    The proposed rule would allow the manufacturers of cigarettes and
smokeless tobacco products listed in table 1 of this Federal Register
document to avoid incurring the costs associated with changing their
products' names. Relevant types of costs may include label redesign,
market-testing new names, and additional promotional spending to inform
customers of name changes. Furthermore, because the proposed amendment
ensures that manufacturers may continue to use a trade or brand name
for their tobacco product even if that name is subsequently used or
registered for use with the USPTO, it would allow an unknown number of
additional producers to avoid these name change costs.
    Another benefit of the rule accrues to consumers of tobacco
products that are out of compliance with the reissued 1996 final rule
but are not profitable enough to justify the cost of a name change.
Without this proposed amendment, such products could be discontinued
and their consumers (other than those who quit using tobacco products)
would have to switch to less-preferred brands.

C. Costs of the Proposed Rule

    The costs imposed on society by the proposed rule can take the
following forms: (1) Reduced producer profits (sales revenues minus
production cost) that are not offset by increased profits of other
firms or (2) losses borne by consumers. Costs in the form of reduced
producer profits are likely to be zero since the proposed amendment
would allow firms to avoid incurring production costs associated with
renaming their products (as discussed in section V.B of this Federal
Register document) and the proposed amendment would not change total
sales of cigarettes and smokeless tobacco products (though sales may
shift between particular brands as discussed in section V.D of this
Federal Register document).
    Losses borne by consumers take the form of health and life
expectancy effects. To the extent that (a) Young people initiate
tobacco use based on imagery from nontobacco products that

share brand names with cigarettes and smokeless tobacco and (b) current
users of these products continue consuming tobacco due only to brand
loyalty, morbidity and mortality will increase, most notably among
those new tobacco users but also among individuals exposed to passive
smoking. FDA anticipates, however, these types of costs due to changing
the grandfather date will be negligible since sales of the affected
tobacco products are low overall and are expected to remain low in the
future.\7\ Moreover, given the addictive nature of tobacco and the lack
of strong brand imagery associated with the affected products, brand
loyalty is unlikely to be a primary factor in the continuance of
tobacco consumption by established users of these products. Thus, FDA
estimates the total cost of the proposed amendment to be near zero.
---------------------------------------------------------------------------

    \7\ Most of the nontobacco products with which they share names
(examples are listed in table 1) are not widely-recognized consumer
products and lack strong brand equity; consequently, consumers,
including youth, are not likely to identify the nontobacco product
names with particular brand images, much less be motivated by them
to initiate or continue tobacco use.
---------------------------------------------------------------------------

D. Distributional Effects of the Proposed Rule

    In the absence of the proposed amendment, name changes would be
required for the 17 products listed in table 1 of this Federal Register
document. If current consumers of these products do not switch to the
renamed products, it is likely, given the addictive nature of tobacco,
that at least some would start consuming other brands of cigarettes or
smokeless tobacco.\8\ The amendment, by preventing this shift in sales,
maintains value for the producers of table 1 products, instead of
transferring value to producers of substitute products as would occur
under the rule as originally published.
---------------------------------------------------------------------------

    \8\ If a discontinued product has a low sales volume, there are
a large array of similar products on the market to which consumers
could switch.
---------------------------------------------------------------------------

VI. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires Agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Section 916(a)(2) of the FD&C Act (21 U.S.C.
387p) expressly preempts any State or local requirement ``which is
different from, or in addition to, any requirement under [Chapter IX of
the FD&C Act] relating to'', among other things, misbranding. This
express preemption provision, however, ``does not apply to requirements
relating to'' among other things ``the sale, distribution, * * * access
to, [or] the advertising and promotion of, * * * tobacco products.'' If
this proposed rule is made final, the final rule would modify the
existing restrictions on the sale and distribution of cigarettes and
smokeless tobacco products. The failure to comply with those
restrictions, as modified, renders the product misbranded under the
FD&C Act.

VII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

VIII. Requests for Comments

    FDA is requesting comments on this proposed rule. In drafting this
proposal, FDA was aware of concerns that had been raised by Sec.
1140.16(a) of the reissued 1996 final rule, including claims raised in
litigation brought in federal district court challenging the
constitutionality of the rule. After considering these concerns and
claims, FDA is proposing to narrow the scope of the existing rule.
    The current rule is intended to ensure that other restrictions on
the sale and distribution of cigarettes and smokeless tobacco products
to children and adolescents are not undermined by a tobacco
manufacturer attempting to exploit the imagery or consumer
identification attached to a nontobacco product. We request comments,
including any data or information, on whether the proposal adequately
addresses this goal, including topics such as the importance of brand
names to children and adolescents, criteria FDA could use to evaluate
whether a particular brand name has appeal to children and adolescents
and under what circumstances a brand name might acquire appeal to
children and adolescents, the vulnerability of children and adolescents
to targeted marketing strategies, and instances where brand names have
been used to attract the youth market.
    With respect to the request for exemption process in proposed Sec.
1140.16(a)(3), the Agency requests comments on the standard
manufacturers should be required to meet to qualify for the exemption
(whether substantial appeal to youth or some other standard), as well
as the criteria and specific types of information that should be
required to demonstrate that a name does not exceed the standard in its
appeal to youth. FDA also requests comments on alternative approaches
to narrowing the restriction, such as prohibiting use of a registered
nontobacco brand name on a tobacco product only if such name is
registered to the same, related, or affiliated entity or is used under
a licensing agreement (under the assumption that non-affiliated
companies would protect their registered brand names that have strong
imagery or consumer identification). If you suggest this or an
alternative approach, you should address the basis for the limitation,
such as by providing data or information showing how this limitation
will ensure that manufacturers do not exploit the imagery or consumer
identification attached to a nontobacco product.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IX. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m. Monday through Friday.
(FDA has verified Web site addresses, but FDA is not responsible for
any subsequent changes to the Web sites after this document publishes
in the Federal Register.)

1. Centers for Disease Control and Prevention, ``Tobacco Use Among
Middle and High School Students--United States, 2000-2009,''
Morbidity and Mortality Weekly Report, 59(33); 1063-1068, August 27,
2010, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5933a2.htm.
2. Centers for Disease Control and Prevention, ``Trends in Smoking
Initiation Among Adolescents and Young Adults--United States, 1980-
1989,'' Morbidity and Mortality Weekly Report, 44(28); 521-525, July
21, 1995, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/00038190.htm.
3. Centers for Disease Control and Prevention, ``Youth Risk Behavior
Surveillance--United States, 2009,'' Morbidity and Mortality Weekly
Report,

59 (No. SS-5): June 4, 2010, available at http://www.cdc.gov/mmwr/pdf/ss/ss5905.pdf.
4. Johnston, L.D., et al., ``Smoking Continues Gradual Decline Among
U.S. Teens, Smokeless Tobacco Threatens a Comeback,'' University of
Michigan News Service: Ann Arbor, MI, December 14, 2009, available
at http://www.monitoringthefuture.org/data/09data.html#2009data-cigs.
5. Centers for Disease Control and Prevention, ``Tobacco Use and the
Health of Young People,'' July 5, 2011, available at http://www.cdc.gov/HealthyYouth/tobacco/facts.htm.
6. 1994 Institute of Medicine, Growing Up Tobacco Free: Preventing
Nicotine Addiction in Children and Youths,'' Washington, DC:
National Academy Press (1994), (``[T]obacco advertising and
promotion undoubtedly contribute to the multiple and convergent
psychosocial influences that lead children and youths to begin using
these products and to become addicted to them.'')
7. Finding 2673, United States v. Philip Morris, 449 F. Supp 2d 1,
990 (D.D.C. 2006) (``[M]arketing has been and continues to be
enormously effective in influencing young people to smoke.''), aff'd
in relevant part, 566 F.3d 1095 (D.C. Cir. 2009) (per curiam), cert.
denied, 130 S. Ct. 3501 (2010).
8. Shadel, W.G. and Tharp-Taylor, S., ``How Does Exposure to
Cigarette Advertising Contribute to Smoking in Adolescents? The Role
of Developing Self-Concept and Identification With Advertising
Models,'' Addictive Behavior, 34(11); 932-937, November 2009.
9. Krugman, Dean M., et al., ``Understanding the Role of Cigarette
Promotion and Youth Smoking in a Changing Marketing Environment,''
Journal of Health Communications, 10:261-278, 2005 (``Advertising
and promotion continue to play an important role in selling
cigarettes to youth even after the 1998 MSA [Master Settlement
Agreement].'')
10. Henriksen, Lisa, et al., ``A Longitudinal Study of Exposure to
Retail Cigarette Advertising and Smoking Initiation,'' Pediatrics,
126(2); 232-238, August 2010, available at http://pediatrics.aappublications.org/cgi/content/abstract/126/2/232.
11. Federal Trade Commission Cigarette Report for 2007 and 2008
(issued 2011), available at http://www.ftc.gov/os/2011/07/110729cigarettereport.pdf, and Federal Trade Commission Smokeless
Tobacco Report for 2007 and 2008 (issued 2011), available at http://www.ftc.gov/os/2011/07/110729smokelesstobaccoreport.pdf (In 2008,
the tobacco industry spent $9.94 billion on advertising and
promotion of cigarettes, and another $547.9 million for smokeless
tobacco products.)
12. National Cancer Institute, ``The Role of Media in Promoting and
Reducing Tobacco Use,'' NCI Tobacco Monograph Series, Monograph 19,
NIH Publication No. 07-6242, 2008, available at http://cancercontrol.cancer.gov/TCRB/monographs/19/index.html.
13. Aaker, David A., ``Managing Brand Equity: Capitalizing on the
Value of a Brand Name,'' The Free Press, 1991.
14. Achenreiner, Gwen B., and John, Deborah R., ``The Meaning of
Brand Names to Children: A Developmental Investigation,'' Journal of
Consumer Psychology 13(3), 205-219, 217, 2003.
15. Lee, R.G., Taylor, V, and McGetrick, R., ``Toward Reducing Youth
Exposure to Tobacco Messages: Examining the Breadth of Brand and
Nonbrand Communication,'' Journal of Health Communication, Vol.
9:461-479, 466, 2004. (``In summary, our examination of product
brand communications indicates that in the wake of the MSA [Master
Settlement Agreement], tobacco firms have channeled their
promotional efforts away from restricted media and into a different
mix of activities that are permissible, in a fashion similar to the
changes after the 1971 broadcast ban. * * * These redistributed
industry promotional activities not only work against the objectives
of the MSA, but also contribute to the breadth of protobacco
messages facing youth.'')
16. Burritt, Chris, ``Swedish Match Targets Wall Street Smokers With
Snus Tobacco,'' Bloomberg News Service, March 16, 2010, http://
www.bloomberg.com/apps/
news?pid=conewsstory&tkr+MO:US&sid=aDwD6ER.R4--Y.
17. ``Form 10-K for Star Scientific, Inc,'' Yahoo! Finance, March
16, 2010.
18. ``Indian Tribe Launches New Cigarette Brand,'' All Business,
April 20, 2004, available at http://www.allbusiness.com/retail-trade/food-stores/4482001-1.html.
19. Pederson, L.L. and D.E. Nelson, ``Literature Review and Summary
of Perceptions, Attitudes, Beliefs, and Marketing of Potentially
Reduced Exposure Products: Communication Implications,'' Nicotine &
Tobacco Research, 9(5): 525-534, May 2007.
20. Roerty, Gerard J., et al., Letter to Lawrence Deyton, Director
of the Center for Tobacco Products, October 22, 2009.
21. Tobacco Products Wikiproducts Site, available at http://tobaccoproducts.org/index.php/Main_Page.
22. United States Patent and Trademark Office, Trademark Electronic
Search System (TESS), available at http://tess2.uspto.gov/bin/gate.exe? f=searchstr&state=4004:9eb3t4.1.1.
23. SAMHSA, Office of Applied Studies, The NSDUH Report: Cigarette
Brand Preferences in 2005, January 12, 2007, http://www.oas.samhsa.gov/2k7/cigBrands/cigBrands.pdf.
24. Maxwell, John C, The Maxwell Report: Year-End and Fourth Quarter
2008 Sales Estimates for the Cigarette Industry, Richmond, VA: John
C. Maxwell, Jr., February 2009.
25. O'Hegarty, M., et al., ``Cigarette Brand Preference Among Middle
and High School Students Who Are Established Smokers: United States,
2004 and 2006,'' Morbidity and Mortality Weekly Report, 58 (5): 112-
115, February 13, 2009, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5805a3.htm.
26. SAMHSA, Office of Applied Studies, ``Results From the 2005
National Survey on Drug Use and Health: Detailed Tables,'' September
2006, http://www.oas.samhsa.gov/NSDUH/2k5nsduh/tabs/Sect7peTabs58to67.pdf.

List of Subjects in 21 CFR Part 1140

    Advertising, Labeling, Smoking, Tobacco.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, as
amended by section 102 of the Tobacco Control Act, and under the
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 1140 be amended as follows:

PART 1140--CIGARETTES AND SMOKELESS TOBACCO

    1. The authority citation for 21 CFR part 1140 reads as follows:

    Authority: 21 U.S.C. 301 et seq., Sec. 102, Pub. L. 111-31, 123
Stat. 1776.

    2. In Sec.  1140.16, revise paragraph (a) to read as follows:

Sec.  1140.16  Conditions of manufacture, sale, and distribution.

    (a) Restriction on product names. (1) Except as provided in
paragraph (a)(2) or (a)(3) of this section, a manufacturer shall not
use a trade or brand name for a cigarette or smokeless tobacco product
if that name was registered with the United States Patent and Trademark
Office for a nontobacco product on the date the tobacco product was
first sold in the United States.
    (2) Paragraph (a)(1) of this section does not apply to a cigarette
or smokeless tobacco product sold on or before June 22, 2009.
    (3) A manufacturer may request an exemption from the restriction on
use of a trade or brand name in paragraph (a)(1) of this section. Such
request must be in writing to the Director of the Center for Tobacco
Products and contain sufficient information to demonstrate that the
trade or brand name that is registered for a nontobacco product does
not, based on its use for the nontobacco product, have a substantial
appeal to children or adolescents.
* * * * *

    Dated: November 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29702 Filed 11-16-11; 8:45 am]
BILLING CODE 4160-01-P