[Federal Register Volume 78, Number 62 (Monday, April 1, 2013)]
[Notices]
[Pages 19506-19507]
[FR Doc No: 2013-07523]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2010-0164]

National Boating Safety Advisory Council

AGENCY: Coast Guard, DHS.

ACTION: Notice of teleconference meeting.

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SUMMARY: The Prevention Through People Subcommittee of the National
Boating Safety Advisory Council (NBSAC) will meet via teleconference
and online webinar to discuss issues related to improving safety of
recreational boating through the development of safer boating
practices. This teleconference meeting will be open to the public.

DATES: The teleconference/webinar meeting will take place on Monday,
April 29, 2013, from 1 p.m. to 3 p.m. EST. This meeting may end early
if all business is finished before 3 p.m. If you wish to make oral
comments at the teleconference, simply notify Mr. Jeff Ludwig before
the meeting, as specified in the ADDRESSES section, or the designated
Coast Guard staff at the meeting. If you wish to submit written
comments or make a presentation, submit your comments or request to
make a presentation by April 19, 2013.

ADDRESSES: The Subcommittee will meet via teleconference and online
webinar. To participate by phone and view the webinar, contact the
Alternate Designated Federal Officer (ADFO) listed below in the FOR
FURTHER INFORMATION CONTACT section to obtain teleconference/webinar
information. Note the number of teleconference lines is limited and
will be available on a first-come, first-served basis. To join those
participating in this teleconference from U.S. Coast Guard
Headquarters, come to Room 5-0624, U.S. Coast Guard Headquarters
Building, 2100 Second Street SW.,

Washington, DC 20593. You must present a valid, government-issued photo
identification to gain entrance to the Coast Guard Headquarters
building.
    If you want to make a presentation, send your request by April 19,
2013, to Mr. Jeff Ludwig, NBSAC ADFO, telephone<PHONE_NUMBER>,
Commandant (CG-BSX-2), 2100 Second Street SW., Stop 7581, Washington,
DC 20593-7581 or by fax to<PHONE_NUMBER>. To facilitate public
participation, we are inviting public comment on the issues to be
considered by the committee as listed in the ``Agenda'' section below.
You may submit a written comment on or before April 19, 2013 or make an
oral comment during the public comment portion of the meeting.
    To submit a comment in writing, use one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Email<EMAIL_ADDRESS>Include the docket
number (USCG-2010-0164) on the subject line of the message.
     Fax:<PHONE_NUMBER> Include the docket number (USCG-2010-
0164) on the subject line of the fax.
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Same as mail address above, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>.

    Instructions: Include the words ``Department of Homeland Security''
and the docket number of this notice in your submission. All comments
submitted will be posted on www.regulations.gov without alteration and
will contain personal information you provided. You may review a
Privacy Act notice regarding our public dockets in the January 17,
2008, issue of the Federal Register (73 FR 3316).
    Docket: For access to the docket to read documents or comments
related to this NBSAC meeting, go to www.regulations.gov, insert
``USCG-2010-0164'' in the ``Search'' box and then click ``Search.''

FOR FURTHER INFORMATION CONTACT: Mr. Jeff Ludwig, USCG, NBSAC ADFO,
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you have
any questions on viewing or submitting material to the docket, call
Barbara Hairston, Program Manager, Docket Operations, telephone 202-
366-9826.

SUPPLEMENTARY INFORMATION: We are publishing this meeting notice under
provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C.
Appendix. NBSAC provides advice and recommendations to the Department
of Homeland Security on matters relating to recreational boating
safety. See 33 U.S.C. 13110.

Agenda of Meeting

    The agenda for April 29, 2013 includes:
    (1) Discussion of issues related to improving safety of
recreational boating through the development of safer boating
practices.
    (2) Public comment.
    A final agenda will be available on http://homeport.uscg.mil/NBSAC
NLT April 15, 2013.

Public Participation

    We have scheduled the last fifteen minutes of the meeting, from
2:45 to 3 p.m., for oral comments from the public. If you wish to make
an oral comment, please contact Mr. Jeff Ludwig, listed in the FOR
FURTHER INFORMATION CONTACT section, either before the meeting or at
the meeting when the members of the audience are requested to state
their interest in commenting. We request that you limit your oral
comments to 3 minutes. Please note that this public comment period may
start before 2:45 p.m. if all other agenda items have been covered and
may end before 3 p.m. if all of those wishing to comment have done so.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the teleconference,
please contact the individuals listed in the FOR FURTHER INFORMATION
CONTACT section, as soon as possible.

    Dated: Mar 26, 2013.
David S. Fish,
Captain, U.S. Coast Guard, Acting Director of Inspections and
Compliance.
[FR Doc. 2013-07523 Filed 3-29-13; 8:45 am]
BILLING CODE 9110-04-P


region facility species. orig stage year impinged. est entrained. est dummy dummy dummy dummy dummy  99  99 inland bayway bay. anchovy egg 1994 . 546276 inland bayway grubby egg 1994 . 365 inland bayway unidentified egg 1994 . 2341 inland bayway windowpane egg 1994 . 6 inland bayway american. eel juv 1994 . 26 inland bayway american. sandlance juv 1994 . 9 inland bayway atlantic. herring juv 1994 . 26 inland bayway bay. anchovy juv 1994 . 173 inland bayway grubby juv 1994 . 26 inland bayway naked. goby juv 1994 . 13 inland bayway northern. pipefish juv 1994 . 9 inland bayway sciaenidae. spp juv 1994 . 9 inland bayway seahorse juv 1994 . 17 inland bayway smallmouth. flounder juv 1994 . 17 inland bayway spot juv 1994 . 17 inland bayway striped. searobin juv 1994 . 26 inland bayway weakfish juv 1994 . 9 inland bayway winter. flounder juv 1994 . 408 inland bayway alosa. spp larvae 1994 . 71 inland bayway american. sandlance larvae 1994 . 71 inland bayway atlantic. croaker larvae 1994 . 71 inland bayway atlantic. herring larvae 1994 . 36 inland bayway atlantic. menhaden larvae 1994 . 48 inland bayway atlantic. silverside larvae 1994 . 12 inland bayway bay. anchovy larvae 1994 . 115,580 inland bayway blenniidae larvae 1994 . 12 inland bayway fundulus. spp larvae 1994 . 60 inland bayway gobiidae larvae 1994 . 5088 inland bayway grubby larvae 1994 . 3455 inland bayway menidia. spp larvae 1994 . 250 inland bayway naked. goby larvae 1994 . 6,822 inland bayway northern. pipefish larvae 1994 . 715 inland bayway rough. silverside larvae 1994 . 12 inland bayway sciaenidae. spp larvae 1994 . 191 inland bayway seahorse larvae 1994 . 12 inland bayway tautog larvae 1994 . 71 inland bayway unidentified larvae 1994 . 179 inland bayway weakfish larvae 1994 . 524 inland bayway windowpane larvae 1994 . 131 inland bayway winter. flounder larvae3 1994 . 6,056 inland bayway bay. anchovy larvae 1994 . 3819 inland bayway northern. puffer larvae 1994 . 13 inland bayway winter. flounder larvae2 1994 . 2203 inland bayway blue. crab age01 1994 1779 . inland bayway smallmouth. flounder age01 1994 255 . inland bayway winter. flounder age01 1994 199 . inland bayway grubby age01 1994 59 . inland bayway atlantic. silverside age01 1994 49 . inland bayway butterfish age01 1994 49 . inland bayway silver. hake age01 1994 39 . inland bayway cunner age01 1994 39 . inland bayway bay. anchovy age01 1994 53 . inland bayway seahorse age01 1994 29 . inland bayway striped. searobin age01 1994 20 . inland bayway gadidae. spp age01 1994 20 . inland bayway spot age01 1994 10 . inland bayway northern. puffer age01 1994 10 . inland bayway tautog age01 1994 10 . inland bayway bluefish age01 1994 10 . inland bayway weakfish age01 1994 10 . inland bayway red. hake age01 1994 10 . inland bayway feather. blenny age01 1994 10 . inland bayway gobiidae age01 1994 10 . inland bayway naked. goby age01 1994 24 . inland bayway striped. killifish age01 1994 10 . inland bayway atlantic. croaker age01 1994 10 . inland bayway threespine. stickleback age01 1994 480 . inland bayway white. perch age01 1994 176 . inland bayway mummichog age01 1994 10 . inland bayway striped. bass age01 1994 137 . inland bayway rainbow. smelt age01 1994 78 . inland bayway alewife age01 1994 49 . inland bayway alosa. spp age01 1994 10 . inland bayway blueback. herring age01 1994 10 . inland bayway gizzard. shad age01 1994 108 . inland bayway anguilla. rostrata age01 1975 511 . inland bayway conger. oceanicus age01 1975 5 . inland bayway alosa. aestivalis age01 1975 20,658 . inland bayway alosa. pseudoharengus age01 1975 1,977 . inland bayway alosa. sapidissima age01 1975 601 . inland bayway brevoortia. tyrannus age01 1975 174 . inland bayway dorosoma. cepedianum age01 1975 7 . inland bayway anchoa. sp age01 1975 5 . inland bayway anchoa. hepsetus age01 1975 21 . inland bayway anchoa. mitchilli age01 1975 11,560 . inland bayway osmerus. mordax age01 1975 27 . inland bayway carrassius. auratus age01 1975 6 . inland bayway cyprinus. carpio age01 1975 6 . inland bayway hybognathus. nuchalis age01 1975 7 . inland bayway merluccius. bilinearis age01 1975 10,753 . inland bayway microgadus. tomcod age01 1975 1,236 . inland bayway urophycis. chuss age01 1975 765 . inland bayway urophycis. regius age01 1975 100 . inland bayway urophycis. tenuis age01 1975 167 . inland bayway fundulus. heteroclitus age01 1975 85,679 . inland bayway menidia. beryllina age01 1975 25 . inland bayway menidia. menidia age01 1975 164 . inland bayway apeltes. quadracus age01 1975 5 . inland bayway gasterosteus. aculeatus age01 1975 142 . inland bayway hippocampus. erectus age01 1975 293 . inland bayway sygnathus. fuscus age01 1975 184 . inland bayway morone. americana age01 1975 255 . inland bayway morone. saxatilis age01 1975 524 . inland bayway lepomis. gibbosus age01 1975 24 . inland bayway lepomis. macrochirus age01 1975 63 . inland bayway poxomis. niromaculatus age01 1975 6 . inland bayway pomatomus. saltatrix age01 1975 517 . inland bayway selene. vomer age01 1975 34 . inland bayway bairdiella. chrysura age01 1975 10 . inland bayway cynoscion. regalis age01 1975 675 . inland bayway stenotomus. chrysops age01 1975 63 . inland bayway tautoga. onitus age01 1975 5 . inland bayway gobiosoma. sp age01 1975 60 . inland bayway gobiosoma. bosci age01 1975 11 . inland bayway peprilus. triacanthus age01 1975 22 . inland bayway prionotus. carolinus age01 1975 35 . inland bayway prionotus. evolans age01 1975 18 . inland bayway myoxocephalus. aenaeus age01 1975 165 . inland bayway scophthalmus. aquosus age01 1975 13 . inland bayway etropus. microstomus age01 1975 158 . inland bayway pseudopleuronectes. americanus age01 1975 108 . inland bayway sphoeroides. maculatus age01 1975 5 . notes qc stage. orig dummy dummy dummy derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage egg derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage egg derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage egg derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage egg derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage juv derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage juv derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage juv derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage juv derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage juv derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage juv derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage juv derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage juv derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage juv derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage juv derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage juv derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage juv derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage juv derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage juv derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage pysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage pysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage pysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage larvae derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage pysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage larvae derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage pysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage pysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage pysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage pysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage larvae derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage pysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage pysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage larvae derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage pysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage pysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage pysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage larvae derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage pysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage larvae derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage larvae derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage larvae3 derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage ysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage ysl derived from table 6 2 and 6 1 of rm 36594' table6 2 values used agage larvae2 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 derived from table 6 3 and 6 4 of rm 36594' table6 4 values used agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 table39 p. 216 and imp survival from table42 p. 224 rm 36593 agage age01 ***** Draft Confidential and Deliberative ; Do not Cite or Quote *****

no ent values from this report 36593 are used DCTM_ ARP. xls ; ent. entry. 36593 page 7 of 17 6/ 23/ 2006 ***** Draft Confidential and Deliberative ; Do not Cite or Quote *****

table 76 rm 36593 april 1980 one month is not enough to represent all of 1980; disregard this table mean alive. pct 9.45%

table39 p. 216 may75 may76 imp mortality table42 species. orig impinged. est. nomortcorrection alive total alive. pct impinged. est note qc anguilla. rostrata 803 4 7 36.36% 511 table39 p. 216 agage conger. oceanicus 6 5 table39 p. 216 agage alosa. aestivalis 20955 2 139 1.42% 20,658 table39 p. 216 agage alosa. pseudoharengus 1977 0 32 0.00% 1,977 table39 p. 216 agage alosa. sapidissima 601 0 8 0.00% 601 table39 p. 216 agage brevootia. tyrannus 174 0 1 0.00% 174 table39 p. 216 agage dorosoma. cepedianum 8 7 table39 p. 216 agage anchos. sp 6 5 table39 p. 216 agage anchoa. hepsetus 23 21 table39 p. 216 agage anchoa. mitchilli 11632 1 160 0.62% 11,560 table39 p. 216 agage osmerus. mordax 27 0 1 0.00% 27 table39 p. 216 agage carrassius. auratus 7 6 table39 p. 216 agage cyprinus. carpio 7 6 table39 p. 216 agage hybognathus. nuchalis 8 7 table39 p. 216 agage merluccius. bilinearis 11009 3 126 2.33% 10,753 table39 p. 216 agage microgadus. tomcod 1236 0 5 0.00% 1,236 table39 p. 216 agage urophycis chuss 765 0 1 0.00% 765 table39 p. 216 agage urophycis. regius 110 0 100 table39 p. 216 agage urophycis. tenuis 184 0 167 table39 p. 216 agage fundulus. heteroclitus 113896 275 835 24.77% 85,679 table39 p. 216 agage menidia. beryllina 28 0 25 table39 p. 216 agage menidia. menidia 164 0 3 0.00% 164 table39 p. 216 agage apeltes. quadracus 6 5 table39 p. 216 agage gasterosteus. aculeatus 142 0 4 0.00% 142 table39 p. 216 agage hippocampus. erectus 293 0 2 0.00% 293 table39 p. 216 agage sygnathus. fuscus 184 0 3 0.00% 184 table39 p. 216 agage morone. americna 255 0 4 0.00% 255 table39 p. 216 agage morone. saxatilis 524 0 9 0.00% 524 table39 p. 216 agage lepomis. gibbosus 24 0 1 0.00% 24 table39 p. 216 agage lepomis. macrochirus 94 1 2 33.33% 63 table39 p. 216 agage poxomis. niromaculatus 7 6 table39 p. 216 agage pomatomus. saltatrix 571 517 table39 p. 216 agage selene. vomer 38 0 1 0.00% 34 table39 p. 216 agage bairdiella. chrysura 20 1 1 50.00% 10 table39 p. 216 agage cynoscion. regalis 675 0 4 0.00% 675 table39 p. 216 agage stentomus. chysops 70 63 table39 p. 216 agage tautoga. onitus 6 5 table39 p. 216 agage gobiosoma. sp 66 60 table39 p. 216 agage gobiosoma. bosci 12 11 table39 p. 216 agage peprilus. triacanthus 24 22 table39 p. 216 agage prionotus. carolinus 39 35 table39 p. 216 agage prionotus. evolans 20 18 table39 p. 216 agage myoxocephalus. aenaeus 220 1 3 25.00% 165 table39 p. 216 agage scophthalmus. aquosus 14 13 table39 p. 216 agage etropus. microstomus 210 1 3 25.00% 158 table39 p. 216 agage pseudopleuronectes. americanus 172 3 5 37.50% 108 table39 p. 216 agage sphoeroides. maculatus 6 5 table39 p. 216 agage DCTM_ ARP. xls ; imp. entry. 36593 page 8 of 17 6/ 23/ 2006 table 6 3 rm 36594 species total. number table6.4. annualized. total implied. scalar weghted weighted. meanimpinged. est blue. crab 200 1779 8.90 15824.205 9.80471327 1779 smallmouth. flounder 26 255 winter. flounder 13 199 15.31 3046.230769 199 grubby 6 59 atlantic. silverside 5 49 butterfish 5 49 silver. hake 4 39 cunner 4 39 bay. anchovy 4 53 13.25 702.25 53 seahorse 3 29 striped. searobin 2 20 gadidae. spp 2 20 spot 1 10 northern. puffer 1 10 tautog 1 10 bluefish 1 10 weakfish 1 10 red. hake 1 10 feather. blenny 1 10 gobiidae. spp 1 10 naked. goby 1 24 24.00 576 24 striped. killifish 1 10 atlantic. croaker 1 10 threespine. stickleback 49 480 white. perch 18 176 mummichog 1 10 striped. bass 14 137 rainbow. smelt 8 78 alewife 5 49 alosa. spp 1 10 blueback. herring 1 10 gizzard. shad 11 108 qc agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage rm36594 table 6 1 ent 1994 eggs yolksac. larvae pysl juvenile sum check bay. anchovy 97300 286 15134 25 112,745 winter. flounder 0 165 474 32 671 naked. goby 0 0 445 2 447 gobiidae 0 0 427 0 427 grubby 65 0 290 3 358 northern. pipefish 0 0 60 1 61 weakfish 0 0 44 1 45 menidia. spp 0 0 21 0 21 sciaenidae. spp 0 0 16 1 17 windowpane 1 0 11 0 12 american. sandlance 0 0 6 1 7 atlantic. croaker 0 0 6 0 6 tautog 0 0 6 0 6 atlantic. herring 0 0 3 3 6 atlantic. menhaden 0 0 4 0 4 seahorse 0 0 1 2 3 striped. searobin 0 0 0 3 3 smallmouth. flounder 0 0 0 2 2 spot 0 0 0 2 2 rough. silverside 0 0 1 0 1 northern. puffer 0 1 0 0 1 atlantic. silverside 1 1 blenniidae 0 0 1 0 1 fundulus. spp 0 0 5 0 5 alosa. spp 0 0 6 0 6 american. eel 0 0 0 3 3 unidentified 417 0 15 0 432 rarrange the info above: from table 6 2 implied scaling factor implied annula est qc bay. anchovy eggs 97,300 546,276 5.61 546276 agage winter. flounder eggs 0 0 agage naked. goby eggs 0 0 agage gobiidae eggs 0 0 agage grubby eggs 65 365 agage northern. pipefish eggs 0 0 agage weakfish eggs 0 0 agage menidia. spp eggs 0 0 agage sciaenidae. spp eggs 0 0 agage windowpane eggs 1 6 agage american. sandlance eggs 0 0 agage atlantic. croaker eggs 0 0 agage tautog eggs 0 0 agage atlantic. herring eggs 0 0 agage atlantic. menhaden eggs 0 0 agage seahorse eggs 0 0 agage striped. searobin eggs 0 0 agage smallmouth. flounder eggs 0 0 agage spot eggs 0 0 agage rough. silverside eggs 0 0 agage northern. puffer eggs 0 0 agage atlantic. silverside eggs 0 agage blenniidae eggs 0 0 agage fundulus. spp eggs 0 0 agage alosa. spp eggs 0 0 agage american. eel eggs 0 0 agage unidentified eggs 417 2341 agage bay. anchovy ysl 286 3819 agage winter. flounder ysl 165 2,203 13.35 2203 agage naked. goby ysl 0 0 agage gobiidae ysl 0 0 agage grubby ysl 0 0 agage northern. pipefish ysl 0 0 agage weakfish ysl 0 0 agage menidia. spp ysl 0 0 agage sciaenidae. spp ysl 0 0 agage windowpane ysl 0 0 agage american. sandlance ysl 0 0 agage atlantic. croaker ysl 0 0 agage tautog ysl 0 0 agage atlantic. herring ysl 0 0 agage atlantic. menhaden ysl 0 0 agage seahorse ysl 0 0 agage striped. searobin ysl 0 0 agage smallmouth. flounder ysl 0 0 agage spot ysl 0 0 agage rough. silverside ysl 0 0 agage northern. puffer ysl 1 13 agage atlantic. silverside ysl 0 agage blenniidae ysl 0 0 agage fundulus. spp ysl 0 0 agage alosa. spp ysl 0 0 agage american. eel ysl 0 0 agage unidentified ysl 0 0 agage bay. anchovy pysl 15,134 115,580 7.64 115,580 agage winter. flounder pysl 474 6,056 12.78 6,056 agage naked. goby pysl 445 6,822 15.33 6,822 agage gobiidae pysl 427 5088 agage grubby pysl 290 3455 agage northern. pipefish pysl 60 715 agage weakfish pysl 44 524 agage menidia. spp pysl 21 250 agage sciaenidae. spp pysl 16 191 agage windowpane pysl 11 131 agage american. sandlance pysl 6 71 agage atlantic. croaker pysl 6 71 agage tautog pysl 6 71 agage atlantic. herring pysl 3 36 agage atlantic. menhaden pysl 4 48 agage seahorse pysl 1 12 agage striped. searobin pysl 0 0 agage smallmouth. flounder pysl 0 0 agage spot pysl 0 0 agage rough. silverside pysl 1 12 agage northern. puffer pysl 0 0 agage atlantic. silverside pysl 1 12 agage blenniidae pysl 1 12 agage fundulus. spp pysl 5 60 agage alosa. spp pysl 6 71 agage american. eel pysl 0 0 agage unidentified pysl 15 179 agage bay. anchovy juvenile 25 173 6.92 173 agage winter. flounder juvenile 32 408 12.75 408 agage naked. goby juvenile 2 13 6.50 13 agage gobiidae juvenile 0 0 agage grubby juvenile 3 26 agage northern. pipefish juvenile 1 9 agage weakfish juvenile 1 9 agage menidia. spp juvenile 0 0 agage sciaenidae. spp juvenile 1 9 agage windowpane juvenile 0 0 agage american. sandlance juvenile 1 9 agage atlantic. croaker juvenile 0 0 agage tautog juvenile 0 0 agage atlantic. herring juvenile 3 26 agage atlantic. menhaden juvenile 0 0 agage seahorse juvenile 2 17 agage striped. searobin juvenile 3 26 agage smallmouth. flounder juvenile 2 17 agage spot juvenile 2 17 agage rough. silverside juvenile 0 0 agage northern. puffer juvenile 0 0 agage atlantic. silverside juvenile 0 agage blenniidae juvenile 0 0 agage fundulus. spp juvenile 0 0 agage alosa. spp juvenile 0 0 agage american. eel juvenile 3 26 agage unidentified juvenile 0 0 agage region facility species. orig stage year impinged. est entrained. est bay. anchovy eggs 546276 winter. flounder eggs 0 naked. goby eggs 0 gobiidae eggs 0 grubby eggs 365 northern. pipefish eggs 0 weakfish eggs 0 menidia. spp eggs 0 sciaenidae. spp eggs 0 windowpane eggs 6 american. sandlance eggs 0 atlantic. croaker eggs 0 tautog eggs 0 atlantic. herring eggs 0 atlantic. menhaden eggs 0 seahorse eggs 0 striped. searobin eggs 0 smallmouth. flounder eggs 0 spot eggs 0 rough. silverside eggs 0 northern. puffer eggs 0 atlantic. silverside eggs 0 blenniidae eggs 0 fundulus. spp eggs 0 alosa. spp eggs 0 american. eel eggs 0 unidentified eggs 2341 bay. anchovy ysl 3819 winter. flounder ysl 2203 naked. goby ysl 0 gobiidae ysl 0 grubby ysl 0 northern. pipefish ysl 0 weakfish ysl 0 menidia. spp ysl 0 sciaenidae. spp ysl 0 windowpane ysl 0 american. sandlance ysl 0 atlantic. croaker ysl 0 tautog ysl 0 atlantic. herring ysl 0 atlantic. menhaden ysl 0 seahorse ysl 0 striped. searobin ysl 0 smallmouth. flounder ysl 0 spot ysl 0 rough. silverside ysl 0 northern. puffer ysl 13 atlantic. silverside ysl 0 blenniidae ysl 0 fundulus. spp ysl 0 alosa. spp ysl 0 american. eel ysl 0 unidentified ysl 0 bay. anchovy pysl 115,580 winter. flounder pysl 6,056 naked. goby pysl 6,822 gobiidae pysl 5088 grubby pysl 3455 northern. pipefish pysl 715 weakfish pysl 524 menidia. spp pysl 250 sciaenidae. spp pysl 191 windowpane pysl 131 american. sandlance pysl 71 atlantic. croaker pysl 71 tautog pysl 71 atlantic. herring pysl 36 atlantic. menhaden pysl 48 seahorse pysl 12 striped. searobin pysl 0 smallmouth. flounder pysl 0 spot pysl 0 rough. silverside pysl 12 northern. puffer pysl 0 atlantic. silverside pysl 12 blenniidae pysl 12 fundulus. spp pysl 60 alosa. spp pysl 71 american. eel pysl 0 unidentified pysl 179 bay. anchovy juvenile 173 winter. flounder juvenile 408 naked. goby juvenile 13 gobiidae juvenile 0 grubby juvenile 26 northern. pipefish juvenile 9 weakfish juvenile 9 menidia. spp juvenile 0 sciaenidae. spp juvenile 9 windowpane juvenile 0 american. sandlance juvenile 9 atlantic. croaker juvenile 0 tautog juvenile 0 atlantic. herring juvenile 26 atlantic. menhaden juvenile 0 seahorse juvenile 17 striped. searobin juvenile 26 smallmouth. flounder juvenile 17 spot juvenile 17 rough. silverside juvenile 0 northern. puffer juvenile 0 atlantic. silverside juvenile 0 blenniidae juvenile 0 fundulus. spp juvenile 0 alosa. spp juvenile 0 american. eel juvenile 26 unidentified juvenile 0 extrap. by. source. doc qc agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage agage Losses data for Bayway refinery . Cooling water source: Arthur Kill ; New Jersey rm 36593 and rm36594 calcs and entry by dc 2/ 27/ 04 Notes: 1980 imp data covers too brief a period to include. ( rm36593)

1978 imp data ( rm36593 ) covers only seven months, while the 1975 imp data covers a full year. The report states ( p58) that imp rates were similar in 75 and 78. SO, it seems ok to ignore the incomplete 78 records, especially because rm 36594 provides data from 1994, so inclusion of 78 would tend to overweight the earlier period.

ent records from rm36593 do not include any samples from june or july ( actual data aug75 may76 as per table24, p179). This seems very unusual and probably means tha peak ent was not observed. Decided to not use these ent, especially since 1994 records are available from rm36494 QC AGage, 4/ 12/ 04


[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Proposed Rules]
[Pages 69161-69163]
[FR Doc No: 2011-28835]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1227; Directorate Identifier 2011-NM-100-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700, 701, &
702) airplanes; Model CL-600-2D15 (Regional Jet Series 705) airplanes;
and Model CL-600-2D24 (Regional Jet Series 900) airplanes. This
proposed AD results from mandatory continuing airworthiness information
(MCAI) originated by an aviation authority of another country to
identify and correct an unsafe condition on an aviation product. The
MCAI describes the unsafe condition as:

    A number of reports of aileron control stiffness have been
received on Bombardier Regional Jet aeroplanes. Bombardier has
reviewed the current maintenance tasks for the aileron control
system and determined that an additional maintenance task is
required.

* * * [A]ileron control stiffness during flight * * * could result
in reduced controllability of the aeroplane.

    The proposed AD would require actions that are intended to address
the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by December 23,
2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Cesar Gomez, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2011-1227;
Directorate Identifier 2011-NM-100-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2011-07, dated April 26, 2011 (referred to after this as ``the MCAI''),
to correct an unsafe condition for the specified products. The MCAI
states:

    A number of reports of aileron control stiffness have been
received on Bombardier Regional Jet aeroplanes. Bombardier has
reviewed the current maintenance tasks for the aileron control
system and determined that an additional maintenance task is
required.
    This directive mandates revision of the approved maintenance
schedule to incorporate the discard task for outboard wing aileron
pulleys to prevent aileron control stiffness during flight which
could result in reduced controllability of the aeroplane.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Bombardier, Inc. has issued Temporary Revision 1-41, dated October
22, 2010, to Section 2--Systems/Powerplant Program of Part 1 of the
Bombardier CL-600-2C10, CL-600-2D15, CL-600-2D24, CL-600-2E25
Maintenance Requirements Manual. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 398 products of U.S. registry. We also estimate that
it would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $33,830, or $85 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator.
    ``Subtitle VII: Aviation Programs,'' describes in more detail the
scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the

distribution of power and responsibilities among the various levels of
government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Bombardier, Inc.: Docket No. FAA-2011-1227; Directorate Identifier
2011-NM-100-AD.

Comments Due Date

    (a) We must receive comments by December 23, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all Bombardier, Inc. Model CL-600-2C10
(Regional Jet Series 700, 701, & 702) airplanes; Model CL-600-2D15
(Regional Jet Series 705) airplanes; and Model CL-600-2D24 (Regional
Jet Series 900) airplanes; certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 27: Flight
controls.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    A number of reports of aileron control stiffness have been
received on Bombardier Regional Jet aeroplanes. Bombardier has
reviewed the current maintenance tasks for the aileron control
system and determined that an additional maintenance task is
required.

* * * [A]ileron control stiffness during flight * * * could result
in reduced controllability of the aeroplane.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Within 30 days after the effective date of this AD: Revise
the maintenance program to incorporate Task 271000-218, discard of
the outboard wing aileron pulleys, as specified in Bombardier
Temporary Revision (TR) 1-41, dated October 22, 2010, to Section 2--
Systems/Powerplant Program of Part 1 of the Bombardier CL-600-2C10,
CL-600-2D15, CL-600-2D24, CL-600-2E25 Maintenance Requirements
Manual (MRM). For this task, the initial compliance time starts at
the applicable time specified in paragraphs (g)(1), (g)(2), (g)(3),
or (g)(4) of this AD. Thereafter, operate the airplane according to
the procedures and compliance times in Bombardier TR 1-41, dated
October 22, 2010.
    (1) For airplanes with 10,000 or less total flight hours as of
the effective date of this AD: Prior to the outboard wing aileron
pulley accumulating 12,000 total flight hours.
    (2) For airplanes with more than 10,000 total flight hours but
with 16,000 total flight hours or less as of the effective date of
this AD: Prior to the outboard wing aileron pulley accumulating
17,300 total flight hours, or within 2,000 flight hours after the
effective date of this AD, whichever is earlier.
    (3) For airplanes with more than 16,000 total flight hours but
with 20,000 total flight hours or less as of the effective date of
this AD: Prior to the outboard wing aileron pulley accumulating
20,800 total flight hours, or within 1,300 flight hours after the
effective date of this AD, whichever is earlier.
    (4) For airplanes with more than 20,000 total flight hours as of
the effective date of this AD: Within 800 flight hours after the
effective date of this AD.

    Note 1: The actions required by paragraphs (g) of this AD may be
done by inserting a copy of Bombardier TR 1-41, dated October 22,
2010, into Section 2--Systems/Powerplant Program of Part 1 of the
Bombardier CL-600-2C10, CL-600-2D15, CL-600-2D24, CL-600-2E25 MRM.
When this TR has been included in the general revisions of the MRM,
the general revisions may be inserted in the MRM, and the TR may be
removed from the MRM, provided that the relevant information in the
general revision is identical to that in Bombardier TR 1-41, dated
October 22, 2010.

No Alternative Actions or Intervals

    (h) After accomplishing the revision required by paragraph (g)
of this AD, no alternative actions (e.g., inspections) or intervals
may be used unless the actions or intervals are approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (i)(1) of this AD.

FAA AD Differences

    Note 2:  This AD differs from the MCAI and/or service
information as follows: No differences.

Other FAA AD Provisions

    (i) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the ACO, send it to ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
410, Westbury, New York 11590; telephone<PHONE_NUMBER>; fax (516)
794-5531. Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office. The AMOC approval letter must specifically
reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

Related Information

    (j) Refer to MCAI Transport Canada Civil Aviation Airworthiness
Directive CF-2011-07, dated April 26, 2011; and Bombardier Temporary
Revision 1-41, dated October 22, 2010, to Section 2--Systems/
Powerplant Program of Part 1 of the Bombardier CL-600-2C10, CL-600-
2D15, CL-600-2D24, CL-600-2E25 MRM; for related information.

    Issued in Renton, Washington, on October 31, 2011.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-28835 Filed 11-7-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Proposed Rules]
[Pages 12607-12613]
[FR Doc No: 2016-05384]

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

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2015-N-3785]

Medical Devices; Orthopedic Devices; Classification of Posterior
Cervical Screw Systems

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing
to classify posterior cervical screw systems into class II (special
controls) and to continue to require premarket notification to provide
a reasonable assurance of safety and effectiveness of the device. A
posterior cervical screw system is a prescription device used to
provide immobilization and stabilization in the cervical spine as an
adjunct to spinal fusion surgery. The term ``posterior cervical screw
systems'' is used to distinguish these devices from currently
classified pedicle screw spinal systems cleared for use in other spinal
regions.

DATES: Submit either electronic or written comments by June 8, 2016.
See section IV of this document for the proposed effective date of a
final rule that may issue based on this proposal.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2015-N-3785 for ``Medical Devices; Orthopedic Devices;
Classification of Posterior Cervical Screw Systems.''

Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper 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: Genevieve Hill, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1457, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

A. Statutory and Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
301 et seq.), as amended, established a comprehensive system for the
regulation of medical devices intended for human use. Section 513 of
the FD&C Act (21 U.S.C. 360c) established three categories (classes) of
devices, reflecting the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness. The three
categories of devices are class I (general controls), class II (special
controls), and class III (premarket approval).
    Section 513(a) of the FD&C Act defines the three classes of
devices. Class I devices are those devices for which the general
controls of the FD&C Act (controls authorized by or under section 501,
502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h,
360i, or 360j) or any combination of such sections) are sufficient to
provide reasonable assurance of safety and effectiveness; or those
devices for which insufficient information exists to determine that
general controls are sufficient to provide reasonable assurance of
safety and effectiveness or to establish special controls to provide
such assurance, but because the devices are not purported or
represented to be for a use in supporting or sustaining human life or
for a use which is of substantial importance in preventing impairment
of human health, and do not present a potential unreasonable risk of
illness or injury, are to be regulated by general controls (section
513(a)(1)(A) of the FD&C Act). Class II devices are those devices for
which general controls by themselves are insufficient to provide
reasonable assurance of safety and effectiveness, but for which there
is sufficient information to establish special controls to provide such
assurance, including the issue of performance standards, postmarket
surveillance, patient registries, development and dissemination of
guidelines, recommendations, and other appropriate actions the Agency
deems necessary to provide such assurance (section 513(a)(1)(B) of the
FD&C Act). Class III devices are those devices for which insufficient
information exists to determine that general controls and special
controls would provide a reasonable assurance of safety and
effectiveness, and are purported or represented for a use in supporting
or sustaining human life or for a use which is of substantial
importance in preventing impairment of human health, or present a
potential unreasonable risk of illness or injury (section 513(a)(1)(C)
of the FD&C Act).
    FDA refers to devices that were in commercial distribution before
May 28, 1976 (the date of enactment of the Medical Device Amendments of
1976), as ``preamendments devices.'' Under section 513(d)(1) of the
FD&C Act, FDA classifies these devices after FDA: (1) Receives a
recommendation from a device classification panel (an FDA advisory
committee); (2) publishes the panel's recommendation for comment, along
with a proposed regulation classifying the device; and (3) publishes a
final regulation classifying the device. FDA has classified most
preamendments devices under these procedures.
    A person may market a preamendments device that has been classified
into class III and devices found to be substantially equivalent by
means of premarket notification procedures (510(k)) to such a
preamendments device or to a device within that type without submission
of a premarket approval application (PMA) until FDA issues a final
order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b))
requiring premarket approval or until the device is subsequently
reclassified into class I or class II.
    FDA refers to devices that were not in commercial distribution
prior to May 28, 1976 as ``postamendments devices.'' These devices are
automatically classified by statute (section 513(f) of the FD&C Act)
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval unless, and until, the
device is reclassified into class I or II or FDA issues an order
finding the device to be substantially equivalent, under section 513(i)
of the FD&C Act, to a predicate device that does not require premarket
approval. The Agency determines whether new devices are substantially
equivalent to predicate devices by means of premarket notification
procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and
part 807 of the regulations (21 CFR part 807).

B. Regulatory History of the Device

    The regulatory history of posterior cervical screw systems arose
from that of pedicle screw spinal systems, which are medical devices
similar in design and principle of operation, but differ based on
anatomic use in the spine and their indications for use. Both device
systems are comprised of various interconnecting components such as
longitudinal members (i.e., rods, plates) and screws that are
configured per the

patient's anatomy and implanted into the posterior spine to provide
stabilization as bony fusion occurs. After the enactment of the Medical
Device Amendments of 1976, FDA commenced to identify and classify all
preamendments devices, in accordance with section 513(b) of the FD&C
Act. In the Federal Register of September 4, 1987 (52 FR 33686), FDA
classified a total of 77 generic types of orthopedic devices. Neither
pedicle screw spinal systems nor posterior cervical screw systems were
identified in this initial effort.
    In July 1998, FDA issued a final rule (63 FR 40025, July 27, 1998)
classifying pedicle screw spinal systems as class II devices, and a
technical amendment to this rule was published on May 22, 2001 (66 FR
28051). In the technical amendment, FDA noted that pedicle screw
systems for the following intended uses in the cervical spine (which
are now referred to as posterior cervical screw systems) were in use
prior to May 28,1976 and are therefore considered preamendments
devices: (1) Cervical spondylolisthesis (all grades and types); (2)
cervical spondylolysis; (3) cervical degenerative disc disease; (4)
degeneration of the cervical facets accompanied by instability; (5)
cervical trauma (fracture and dislocation); and (6) revision of failed
previous fusion surgery (pseudarthrosis) of the cervical spine. Since
2001, FDA has regulated posterior cervical screw systems as
unclassified preamendments devices requiring premarket notification
(510(k)). Posterior cervical screw systems currently on the market have
been determined to be substantially equivalent to devices that were in
commercial distribution prior to May 28, 1976.
    On April 9, 2009, FDA published an order under sections 515(i) and
519 of the FD&C Act (515(i) order) for the submission of safety and
effective information on pedicle screw spinal systems with certain
indications for use (74 FR 16214). In response to that order, FDA
received a request from the Orthopedic Surgical Manufacturers
Association (OSMA) to classify posterior cervical screw systems into
class II (special controls). Because this request was considered to be
outside the scope of the 515(i) order related to pedicle screw spinal
systems, FDA requested that OSMA submit a separate petition for
classification of posterior cervical screw systems. OSMA submitted the
requested petition on November 22, 2011, under Docket No. FDA-2011-P-
0851-0001/CCP (Ref. 1). FDA consulted with the Orthopaedic and
Rehabilitation Devices Panel (the Panel), an FDA advisory committee,
regarding the classification of this device type on September 21, 2012
(Ref. 2). At the Panel meeting, the Panel recommended that posterior
cervical screw systems be classified as class II with special controls.

II. Recommendation of the Panel

    During a public meeting held on September 21, 2012, the Panel made
recommendations regarding the classification and regulatory controls
for posterior cervical screw systems.

A. Identification

    FDA is proposing the following identification for posterior
cervical screw systems based on the Panel's recommendations and the
Agency's review. Posterior cervical screw systems utilizing pedicle and
lateral mass screws, implanted from the C1 to C7 levels, are multiple
component devices, made from a variety of materials, including metallic
alloys. Posterior cervical instrumentation generally involves use of a
fixation system comprised of both longitudinal members and screws that
can span various combinations of spinal levels from the occiput to the
upper thoracic spine. Cervical lateral mass and pedicle screws serve as
the primary bone anchor points and require selection based on
individual patient anatomy, as determined by preoperative cross-
sectional imaging. Posterior cervical screw systems consist of a bone
anchor via screws (i.e., occipital screws, cervical lateral mass
screws, cervical pedicle screws, C2 pars screws, C2 translaminar
screws, C2 transarticular screws), longitudinal members (e.g., plates,
rods) and optional transverse connectors. An interconnection mechanism
(e.g., offset connector, nuts, screws, or bolts) may be utilized to
link the anchor and longitudinal member. These posterior cervical screw
systems are statically fixed devices, only intended to be used as an
adjunct to fusion and do not include any dynamic features, which may
include, but are not limited to: Non-uniform and/or non-metallic
longitudinal elements, features that allow more motion or flexibility
compared to traditional rigid systems, or features that do not provide
the system immediate rigid fixation.

B. Recommended Classification of the Panel

    The Panel recommended that posterior cervical screw systems be
classified into class II (special controls).

C. Summary of Reasons for Recommendation

    The Panel considered the panel members' personal knowledge of and
clinical experience with the device type, as well as the history of
safety and effectiveness of the device over many years of clinical use.
The Panel recommended that posterior cervical screw systems be
classified into class II as an adjunct to fusion for the following
acute and chronic instabilities of the cervical spine and
craniocervical junction: (1) Traumatic spinal fractures and/or
traumatic dislocations; instability or deformity; (2) failed previous
fusions (e.g., pseudarthrosis); (3) tumors involving the cervical
spine; and (4) degenerative disease, including intractable
radiculopathy and/or myelopathy, neck and/or arm pain of discogenic
origin as confirmed by radiographic studies, and degenerative disease
of the facets with instability. These systems are also intended to
restore the integrity of the spinal column even in the absence of
fusion for a limited time period in patients with advanced stage tumors
involving the cervical spine in whom life expectancy is of insufficient
duration to permit achievement of fusion. The Panel also found that
there is reasonable evidence to support use of posterior cervical
screws as an adjunct to fusion in the pediatric population. In
addition, there was panel consensus supporting the use of posterior
cervical screws for non-fusion treatment for a limited time period in
patients with advanced stage tumors involving the cervical spine in
whom life expectancy is of insufficient duration to permit achievement
of fusion; the Panel emphasized that their discussions were limited to
this narrow patient population and should not be extrapolated to other
non-fusion applications or technologies (e.g., dynamic stabilization
systems).
    The Panel also recommended that posterior cervical screw systems be
classified into class II because special controls, together with
general controls, would provide reasonable assurance of their safety
and effectiveness. The risks to health for this device type are known
and can be adequately mitigated by special controls (such as mechanical
testing, biocompatibility, and labeling).

D. Risks to Health

    Based on the Panel's discussion and recommendations in addition to
comprehensive literature reviews and analyses by OSMA and FDA, the
risks to health associated with posterior cervical screw systems and
the proposed measures to mitigate these

risks are identified in the following list and in table 1. The
identified risks to health are identical to those proposed by FDA
during the September 21, 2012, panel meeting, with the addition of
risks associated with the presence of vertebral arteries, as
recommended by FDA with panel agreement. FDA determined that the
following risks to health are associated with its use:
     Device failure--Components may deform, fracture, wear,
loosen, or disassemble, resulting in a mechanical or functional
failure.
     Failure at the bone/implant interface--Components may
loosen or disengage from the bone.
     Tissue injury--Intraoperative and postoperative risks of
tissue injury include: Bone fracture, injury to blood vessels or
viscera, neurologic injury, dural tear or cerebrospinal fluid leak,
skin penetration or irritation, and postoperative wound problems,
including infection, hematoma/seroma.
     Adverse tissue reactions--Adverse tissue reactions
include: Foreign body response, metal allergy, and metal toxicity.
     Device malposition--Risks of device malposition may
include difficulty or inability to implant the device components or
incorrect placement of the device.
     Pseudarthrosis--The risk of nonunion, or pseudarthrosis,
signifies failure of bony fusion and potential instability or pain.
     Adverse clinical sequelae--Adverse clinical sequelae may
include the risk of new or unresolved neck pain, new or worsened
neurologic deficit/injury, or loss of correction.
    The risks to health presented to the 2012 Panel such as cardiac,
respiratory, and death are considered general surgical risks associated
with the surgical procedure to implant posterior cervical screw
systems; these risks are not directly associated with posterior
cervical screw systems and therefore are not included in the previous
list of risks. Failure of the posterior cervical screw system as a
result of the risks to health listed may result in the need for
reoperation, revision, or removal.
    While presented to the Panel as a potential risk, graft settling
would not be considered a device-specific risk. Rather, it represents a
potential mechanism for the development of pseudarthrosis, instability,
or lack of correction. Further, graft settling is expected in patients
undergoing fusion surgery and does not necessarily result in adverse
clinical sequelae. Thus this item does not specifically appear in the
previous list.

E. Proposed Special Controls

    FDA believes that the following special controls, in addition to
general controls, are sufficient to mitigate the risks to health
described in section II.D. and provide reasonable assurance of safety
and effectiveness of the device.
     Design characteristics of the device, including
engineering schematics, must ensure that the geometry and material
composition are consistent with the intended use.
     Nonclinical performance testing must demonstrate the
mechanical function and durability of the implant.
     Device must be demonstrated to be biocompatible.
     Validation testing must demonstrate the cleanliness and
sterility of, or the ability to clean and sterilize, the device
components and device-specific instruments.
     Labeling must bear all information required for the safe
and effective use of the device, specifically including the following:
    [cir] Clear description of the technological features of the
device, including identification of device materials and the principles
of device operation;
    [cir] intended use and indications for use including levels of
fixation;
    [cir] device-specific warnings, precautions, and contraindications
that include the following statements:
    [ssquf] ``Precaution: Pre-operative planning prior to implantation
of posterior cervical lateral mass and pedicle screw spinal systems
should include review of cross-sectional imaging studies (e.g., CT and/
or MRI imaging) to evaluate the patient's cervical anatomy including
the transverse foramen and the course of the vertebral arteries. If any
findings would compromise the placement of lateral mass or pedicle
screws, other surgical methods should be considered. In addition, use
of intraoperative imaging should be considered to guide and/or verify
device placement, as necessary.''
    [ssquf] ``Precaution: Use of posterior cervical pedicle screw
fixation at the C3 through C6 spinal levels requires careful
consideration and planning beyond that required for lateral mass screws
placed at these spinal levels, given the proximity of the vertebral
arteries and neurologic structures in relation to the cervical pedicles
at these levels.''
    [cir] identification of magnetic resonance (MR) compatibility
status;
    [cir] cleaning and sterilization instructions for devices and
instruments that are provided non-sterile to the end user; and
    [cir] detailed instructions of each surgical step, including device
removal, accompanied by magnified illustrations.
    Table 1 summarizes the risks to health described in section II.D.
and the proposed special controls that are sufficient to mitigate these
risks.

    Table 1--Summary of Risks to Health and Proposed Special Controls
------------------------------------------------------------------------
                                           Method of mitigation (i.e.,
             Risk to health                      special control)
------------------------------------------------------------------------
Device Failure.........................  Design Characteristics.
                                         Nonclinical Performance
                                          Testing.
                                         Labeling.
Failure of Bone Implant Interface......  Design Characteristics.
                                         Biocompatibility.
                                         Nonclinical Performance
                                          Testing.
                                         Labeling.
Tissue Injury..........................  Labeling.
Adverse Tissue Reactions...............  Design Characteristics.
                                         Biocompatibility.
                                         Sterility.
                                         Labeling.
Device Malposition.....................  Labeling.
Pseudarthrosis.........................  Nonclinical Performance
                                          Testing.
                                         Biocompatibility.
                                         Labeling.
Adverse Clinical Sequelae..............  Labeling.
------------------------------------------------------------------------

    Furthermore, FDA is proposing that posterior cervical screw systems
be prescription devices. Prescription devices must be used in
accordance with 21 CFR 801.109. Prescription-use restrictions are a
type of general controls as defined in section 513(a)(1)(A)(i) of the
FD&C Act.

III. Proposed Classification and FDA's Finding

    In preparation for the September 2012 panel meeting and to better
inform the Agency's proposed classification of posterior cervical screw
systems as described in this proposed rule, FDA conducted a review of
the literature that included relevant scientific and medical
information published through July 2012 (see Section 6 of FDA's Panel
Executive Summary, Ref. 2) as well as adverse events in FDA's
Manufacturer and User Facility Device Experience (MAUDE) database (see
Section 7 of FDA's Panel Executive Summary, Ref. 2). FDA does not
believe that new or different information has become available since
the September 2012 panel meeting that would alter FDA's findings. Based
upon FDA's review of the literature and adverse events and FDA's
continued premarket and postmarket experience with the device type, FDA
agrees with the Panel's recommendation that posterior cervical screw
systems be classified into class II. FDA is proposing to classify these
devices into class II because general controls alone are insufficient
to provide reasonable assurance of the safety and effectiveness of
these implantable devices (see section II.D.), as presented and
discussed during the September 21, 2012, panel meeting (Ref. 2). FDA
also believes there is sufficient information to establish special
controls to mitigate the known risks of the device. Therefore, FDA
proposes that posterior cervical screw systems be classified into class
II. The special controls, in addition to general controls, will provide
reasonable assurance of the safety and effectiveness of the device.

IV. Proposed Effective Date

    FDA proposes that this proposed rule, if finalized, will become
effective 30 days after its date of publication in the Federal
Register. In addition, FDA proposes that once the final rule is in
effect, manufacturers of posterior cervical screw systems as defined in
section II.A. that have not been offered for sale prior to the
effective date of the final rule must obtain 510(k) clearance before
marketing their devices and comply with the special controls.
    FDA notes that a firm who markets a device that is intended for use
as a posterior cervical screw system as identified in section II.A., as
well as other uses, that was legally in commercial distribution before
May 28, 1976, or who markets a device found to be substantially
equivalent to such a device and who does not intend to market such
device for uses other than as a posterior cervical screw as defined in
section II.A., may remove the other intended uses from the device's
labeling and continue marketing the device without submitting a new
510(k). In addition, such posterior cervical screw systems must comply
with the special controls.

V. Environmental Impact, No Significant Impact

    The Agency has determined under 21 CFR 25.34(b) 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.

VI. Economic Analysis of Impacts

    We have 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 us 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). We
have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the proposed rule. We believe that this
proposed rule is not a significant regulatory action as defined by
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because: (1) The proposed regulation would classify a
previously unclassified preamendment device type; (2) only five
registered establishments are listed in the Establishment Registration
and Device Listing database that would be affected by the proposed
rule; and (3) the proposed regulation designating the classification of
posterior cervical screw systems as class II is consistent with the
historical regulatory oversight given to this device type, we proposed
to certify that the rule will not have a significant economic impact on
a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to 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 $144 million, using the most current (2014) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
    This rule proposes to classify posterior cervical screw systems as
class II devices with special controls. These devices are currently
unclassified. Currently, manufacturers are subject to premarket
requirements similar to class II devices, with producers receiving
clearance to market via a 510(k) premarket notification submission
without a PMA requirement. We have concluded that special controls in
addition to general controls are sufficient for ensuring the safety and
effectiveness of these devices and that these devices may be classified
as class II (special controls).
    FDA's Registration and Listing database identifies two large
manufacturers of three posterior cervical screw systems (product code
NKG). Manufacturers of these devices will need to edit any current
labeling to reflect requirements of the proposed rule. This is
considered a major label change because of the addition of precaution
statements. The estimated cost of this labeling change is $13,189 per
product for an estimated total cost of $39,567 (3 x $13,189). Any
currently marketed devices seeking marketing authorization as posterior
cervical screw systems would incur similar costs. We welcome comments
on the number of applications we may receive from firms pursuing
marketing authorization for currently marketed products as posterior
cervical screw systems.
    The proposed rule would require that manufacturers who wish to
market these devices submit 510(k) premarket notifications and comply
with the proposed special controls. It is not expected that
manufacturers of devices already on the market would need to submit new
510(k) notifications, 510(k) amendments, or add-to-files to demonstrate
conformance with the proposed special controls. Any manufacturers
seeking marketing authorization of posterior cervical screw systems
would not incur additional

costs as a result of this rule because we already require 510(k)
submissions for these devices. Hence, the proposed rule would not
result in any significant change in how manufacturers prepare 510(k)
submissions for the affected devices or in how we would review the
submissions. Consequently, compliance with the special controls
proposed for these devices would not yield significant new costs for
manufacturers. Because the formal classification of the affected
devices as class II is consistent with current Agency and industry
practice, we conclude that the proposed rule, if finalized, would not
impose any significant additional regulatory burden.
    We invite comments on this analysis.

VII. Paperwork Reduction Act of 1995

    This proposed rule establishes special controls that refer to
currently approved collections of information found in other 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 (the PRA) (44 U.S.C. 3501-3520). The collections of
information in 21 CFR part 807, subpart E, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
801 have been approved under OMB control number 0910-0485; the
collections of information in 21 CFR part 807 have been approved under
OMB control number 0910-0625. The precaution labeling provisions in
proposed 21 CFR 888.3075(b)(5) are not subject to review by OMB because
they do not constitute a ``collection of information'' under the PRA.
Rather, the following labeling: (1) ``Precaution: Pre-operative
planning prior to implantation of posterior cervical lateral mass and
pedicle screw spinal systems should include review of cross-sectional
imaging studies (e.g., CT and/or MRI imaging) to evaluate the patient's
cervical anatomy including the transverse foramen and the course of the
vertebral arteries. If any findings would compromise the placement of
lateral mass or pedicle screws, other surgical methods should be
considered. In addition, use of intraoperative imaging should be
considered to guide and/or verify device placement, as necessary.'' (2)
``Precaution: Use of posterior cervical pedicle screw fixation at the
C3 through C6 spinal levels requires careful consideration and planning
beyond that required for lateral mass screws placed at these spinal
levels, given the proximity of the vertebral arteries and neurologic
structures in relation to the cervical pedicles at these levels.'' are
a ``public disclosure of information originally supplied by the Federal
government to the recipient for the purpose of disclosure to the
public'' (5 CFR 1320.3(c)(2)).

VIII. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

    1. Orthopedic Surgical Manufacturers Association Reclassification
Petition filed on November 23, 2011, to support classification of
pedicle and lateral mass screws for cervical spine use from
unclassified status to class II. Available at www.regulations.gov, the
docket number is FDA-2011-P-0851.
    2. Transcript and other meeting materials from the Food and Drug
Administration Orthopedic Devices Panel Meeting, September 21, 2012,
(http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm309184.htm).

List of Subjects in 21 CFR Part 888

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, FDA proposes
to amend 21 CFR part 888 as follows:

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for 21 CFR part 888 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.   888.3075 to subpart D to read as follows:

Sec.  888.3075  Posterior cervical screw system.

    (a) Identification. Posterior cervical screw systems, implanted
from the C1 to C7 levels, are prescription devices comprised of
multiple components, made from a variety of materials, including
metallic alloys. Posterior cervical instrumentation generally involves
use of a fixation system comprised of both longitudinal members and
screws that can span various combinations of spinal levels from the
occiput to the upper thoracic spine. Cervical lateral mass and pedicle
screws serve as the primary bone anchor points and require selection
based on individual patient anatomy, as determined by preoperative
cross-sectional imaging. Posterior cervical screw systems consist of a
bone anchor via screws (i.e., occipital screws, cervical lateral mass
screws, cervical pedicle screws, C2 pars screws, C2 translaminar
screws, C2 transarticular screws), longitudinal members (e.g., plates,
rods) and optional transverse connectors. An interconnection mechanism
(e.g., offset connector, nuts, screws, or bolts) may be utilized to
link the anchor and longitudinal member. These posterior cervical screw
systems are intended to provide immobilization and stabilization of
spinal segments (C1 to C7 levels) in patients as an adjunct to fusion
for the following acute and chronic instabilities of the cervical spine
and/or craniocervical junction and/or cervicothoracic junction:
Traumatic spinal fractures and/or traumatic dislocations; spinal
deformities and related instabilities; failed previous fusions (e.g.,
pseudarthrosis); tumors involving the cervical spine; inflammatory
disorders; degenerative disease, including neck and/or arm pain of
discogenic origin as confirmed by radiographic studies; degenerative
disease of the facets with instability; and reconstruction following
decompression to treat intractable radiculopathy and/or myelopathy.
These systems are also intended to restore the integrity of the spinal
column even in the absence of fusion for a limited time period in
patients with advanced stage tumors involving the cervical spine in
whom life expectancy is of insufficient duration to permit achievement
of fusion.
    (b) Classification. Class II (special controls). The special
controls for posterior cervical screw systems are:
    (1) Design characteristics of the device, including engineering
schematics, must ensure that the geometry and material composition are
consistent with the intended use.
    (2) Nonclinical performance testing must demonstrate the mechanical
function and durability of the implant.
    (3) Device must be demonstrated to be biocompatible.
    (4) Validation testing must demonstrate the cleanliness and
sterility of, or the ability to clean and sterilize, the device
components and device-specific instruments.
    (5) Labeling must bear all information required for the safe and
effective use of the device, specifically including the following:
    (i) Clear description of the technological features of the device
including identification of device

materials and the principles of device operation;
    (ii) Intended use and indications for use including levels of
fixation;
    (iii) Device specific warnings, precautions, and contraindications
that include the following statements:
    (A) ``Precaution: Pre-operative planning prior to implantation of
posterior cervical lateral mass and pedicle screw spinal systems should
include review of cross-sectional imaging studies (e.g., CT and/or MRI
imaging) to evaluate the patient's cervical anatomy including the
transverse foramen and the course of the vertebral arteries. If any
findings would compromise the placement of lateral mass or pedicle
screws, other surgical methods should be considered. In addition, use
of intraoperative imaging should be considered to guide and/or verify
device placement, as necessary.''
    (B) ``Precaution: Use of posterior cervical pedicle screw fixation
at the C3 through C6 spinal levels requires careful consideration and
planning beyond that required for lateral mass screws placed at these
spinal levels, given the proximity of the vertebral arteries and
neurologic structures in relation to the cervical pedicles at these
levels.''
    (iv) Identification of magnetic resonance (MR) compatibility
status;
    (v) Sterilization and cleaning instructions for devices and
instruments that are provided non-sterile to the end user, and;
    (vi) Detailed instructions of each surgical step, including device
removal, accompanied by magnified illustrations.

    Dated: March 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05384 Filed 3-9-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: July 26, 2006 (Volume 71, Number 143)]
[Notices]
[Page 42386-42387]
[DOCID:fr26jy06-66]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2003-0348; FRL-8059-7]

Propanil; Notice of Availability of the Propanil Amendment to the
Reregistration Eligibility Decision (RED) and Completion of the Comment
Period for the Propanil RED.

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of the amendment to the
Propanil Reregistration Eligibility Decision (RED) and completion of
the comment period for the propanil RED. The Agency has reviewed the
public comments submitted and has responded to those that relate
specifically to the propanil RED. As a result of its review of the
public comments and review of additional data submitted by the Propanil
Task Force, the Agency is amending the Propanil RED, where appropriate.
EPA develops reregistration decisions pursuant to the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), and tolerance
reassessment decisions under provisions of the Federal Food, Drug and
Cosmetic Act (FFDCA). Through these programs, EPA ensures that all
pesticides meet current health and safety standards.

FOR FURTHER INFORMATION CONTACT: Cathryn O'Connell, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-

mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2003-0348. Publicly
available docket materials are available either electronically at
http://www.regulations.gov or in hard copy at the OPP Regulatory Public

Docket in Rom. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. This Docket Facility is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
Docket Facility telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. Background

A. What Action is the Agency Taking?

    This notice announces the availability of the amendment to the
propanil RED and completion of the comment period for the propanil RED.
The propanil RED document was signed on September 30, 2003. A public
comment period for the Propanil RED (and the supporting assessments)
was conducted from February 25, 2004 to April 26, 2004. The risk
assessments, benefit assessment, and public comments can be found on
the Federal docket system, available at regulations.gov, docket ID
number EPA-HQ-OPP-2003-0348. The Agency has reviewed the public
comments submitted and has responded to those that relate specifically
to the propanil RED. The Agencys responses are available for viewing
under the same docket ID number on the regulations.gov system. As a
result of its review of the public comments and review of additional
data submitted by the Propanil Task Force, the Agency is amending the
propanil RED, where appropriate. These revisions include label changes
and an updated Appendix B: Data Supporting Guideline Requirements for
the Reregisrtaion of Propanil. The label changes related to dry
flowable closed systems are contingent on the outcome of exposure data
that are due in December 2006. EPA considers the amendment to the
propanil RED and the propanil RED final decisions as of the publication
date of this notice.

B. What is the Agency's Authority for Taking this Action?

    Section 4(g)(2) of FIFRA, as amended, directs that, after
submission of all data concerning a pesticide active ingredient, ``the
Administrator shall determine whether pesticides containing such active
ingredient are eligible for reregistration,'' before calling in product
specific data on individual end-use products, and either reregistering
products or taking other ``appropriate regulatory action.''

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: July 13, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-11714 Filed 7-25-06; 8:45 am]

BILLING CODE 6560-50-S