[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Pages 54593-54594]
[FR Doc No: 2018-23641]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3689]

21st Century Cures: Announcing the Establishment of a Surrogate
Endpoint Table; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the establishment of a public docket to receive suggestions and
comments from interested parties (including academic institutions,
regulated industry, and patient groups) on the Agency's publication of
the surrogate endpoint table (SE table). FDA has developed a web page,
available at https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm613636.htm that displays the SE table,
describes the purpose of the table, and provides additional background
information. Comments received on the SE table will help FDA determine
its utility and may assist FDA in developing future iterations of the
SE table and identifying best methods for conveying information about
SEs on the FDA's website.

DATES: Submit either electronic or written comments on this notice by
December 31, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 31, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 31, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-3689 for ``21st Century Cures: Announcing the Establishment
of a Surrogate Endpoint Table.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management

Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Christopher Leptak, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6461, Silver Spring, MD 20993-0002, 301-
796-0017, [email protected]; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 3011 of the 21st Century Cures Act established section 507
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 357),
which mandates that FDA publish a list of surrogate endpoints used as a
basis to approve or license a drug or biological product under both
accelerated and traditional approval provisions. The SE table fulfills
this legislative requirement and is intended to provide valuable
information for drug developers on endpoints that may be considered and
discussed with FDA for individual development programs. FDA refers the
public to the following web page for additional background information
as well as the SE table: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm606684.htm.
    Section 507(e)(9) of the FD&C Act defines the term ``surrogate
endpoint'' to mean a marker, e.g., a laboratory measurement,
radiographic image, physical sign, or other measure, that does not
directly measure clinical benefit but (1) is known to predict clinical
benefit and can potentially be used to support traditional approval of
a drug or biological product or (2) is reasonably likely to predict
clinical benefit and could be used to support accelerated approval in
accordance with section 506(c) of the FD&C Act (21 U.S.C. 356(c)).
    This SE table includes SEs that sponsors have used as primary
efficacy clinical trial endpoints for approval of new drug applications
(NDAs) or biologics license applications (BLAs). The table also
includes SEs that may be appropriate for use as a primary efficacy
clinical trial endpoint for drug or biologic approval, although the SEs
have not necessarily been used to support an approved NDA or BLA. FDA
believes that this table should facilitate discussions of potential SEs
by sponsors when developers are designing their drug development
programs.

II. Additional Issues for Consideration

    To help FDA determine the utility of the SE table, develop future
iterations of the SE table, and identify best methods for conveying
this information on FDA's website, FDA is soliciting public suggestions
and comments on the SE table listed on the following web page: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm606684.htm.
    Specifically, FDA welcomes comments concerning: (1) The utility of
the SE table; (2) suggestions on SEs that may not be reflected on the
current SE table but that have been used for drug or biologic
approvals; (3) the best approach for developing future iterations of
the table, and (4) SE table questions you would like FDA to address in
future communications. As required by section 507(c)(1) of the FD&C
Act, FDA will update this table on the website every 6 months. The
Agency will consider comments submitted to the docket as it revises the
SE table.

    Dated: October 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23641 Filed 10-29-18; 8:45 am]
 BILLING CODE 4164-01-P


.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 28,274 17,812 38,000 45.12 1.97 0.09 0.59 1.76 0.33 107,236 67,559 144,125 171.15 7.48 0.34 2.25 6.67 1.23 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 6,881 4,335 9,248 10.98 0.48 0.02 0.14 0.43 0.08 28,952 18,240 38,912 46.21 2.02 0.09 0.61 1.80 0.33 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 5,821 3,667 7,823 9.29 0.41 0.02 0.12 0.36 0.07 33,977 21,406 45,665 54.23 2.37 0.11 0.71 2.11 0.39 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 98,683 62,171 132,631 157.50 6.88 0.31 2.07 6.13 1.14 327,516 206,335 440,181 522.72 22.83 1.05 6.88 20.36 3.77 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 29 7,412 218,255 2.06 0.49 0.01 0.03 0.03 0.28 39 9,847 289,945 2.74 0.66 0.01 0.04 0.05 0.38 31 7,760 228,477 2.16 0.52 0.01 0.03 0.04 0.30 158 39,783 1,171,403 11.05 2.65 0.06 0.18 0.19 1.53 203 51,003 1,501,765 14.17 3.40 0.08 0.23 0.24 1.96 67 16,773 493,867 4.66 1.12 0.03 0.07 0.08 0.64 55 13,825 407,074 3.84 0.92 0.02 0.06 0.06 0.53 45 11,333 333,681 3.15 0.76 0.02 0.05 0.05 0.43 70 17,651 519,716 4.90 1.18 0.03 0.08 0.08 0.68 105 26,542 781,526 7.37 1.77 0.04 0.12 0.12 1.02 105 1,041 30,645 0.29 0.07 0.00 0.00 0.00 0.04 87 1,031 30,372 0.29 0.07 0.00 0.00 0.00 0.04 71 786 23,150 0.22 0.05 0.00 0.00 0.00 0.03 111 1,858 54,720 0.52 0.12 0.00 0.01 0.01 0.07 166 2,490 73,317 0.69 0.17 0.00 0.01 0.01 0.10 107 89 2,619 0.02 0.01 0.00 0.00 0.00 0.00 88 74 2,188 0.02 0.00 0.00 0.00 0.00 0.00 72 57 1,667 0.02 0.00 0.00 0.00 0.00 0.00 112 129 3,807 0.04 0.01 0.00 0.00 0.00 0.00 169 186 5,477 0.05 0.01 0.00 0.00 0.00 0.01 12 2,487 73,226 0.69 0.17 0.00 0.01 0.01 0.10 9 2,486 73,204 0.69 0.17 0.00 0.01 0.01 0.10 6 1,895 55,799 0.53 0.13 0.00 0.01 0.01 0.07 11 4,485 132,070 1.25 0.30 0.01 0.02 0.02 0.17 15 5,985 176,234 1.66 0.40 0.01 0.03 0.03 0.23 48 12,093 356,086 3.36 0.81 0.02 0.05 0.06 0.46 57 14,319 421,618 3.98 0.95 0.02 0.06 0.07 0.55 36 9,177 270,198 2.55 0.61 0.01 0.04 0.04 0.35 152 38,348 1,129,142 10.65 2.56 0.06 0.17 0.18 1.47 381 95,847 2,822,169 26.62 6.39 0.14 0.42 0.45 3.68 156 39,338 1,158,274 10.93 2.62 0.06 0.17 0.18 1.51 115 28,877 850,279 8.02 1.93 0.04 0.13 0.13 1.11 76 19,126 563,155 5.31 1.28 0.03 0.08 0.09 0.73 103 25,845 760,991 7.18 1.72 0.04 0.11 0.12 0.99 211 53,132 1,564,435 14.76 3.54 0.08 0.23 0.25 2.04 246 1,933 56,913 0.54 0.13 0.00 0.01 0.01 0.07 181 1,503 44,252 0.42 0.10 0.00 0.01 0.01 0.06 120 938 27,618 0.26 0.06 0.00 0.00 0.00 0.04 162 1,814 53,422 0.50 0.12 0.00 0.01 0.01 0.07 333 2,431 71,578 0.68 0.16 0.00 0.01 0.01 0.09 1 165 4,863 0.05 0.01 0.00 0.00 0.00 0.01 0 108 3,187 0.03 0.01 0.00 0.00 0.00 0.00 0 68 1,989 0.02 0.00 0.00 0.00 0.00 0.00 1 126 3,717 0.04 0.01 0.00 0.00 0.00 0.00 1 182 5,347 0.05 0.01 0.00 0.00 0.00 0.01 18 4,619 135,991 1.28 0.31 0.01 0.02 0.02 0.18 14 3,622 106,658 1.01 0.24 0.01 0.02 0.02 0.14 9 2,261 66,567 0.63 0.15 0.00 0.01 0.01 0.09 17 4,379 128,938 1.22 0.29 0.01 0.02 0.02 0.17 23 5,843 172,055 1.62 0.39 0.01 0.03 0.03 0.22 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 1,835 15,868 7,113 0.60 0.17 0.00 0.15 0.00 0.00 2,794 24,156 10,829 0.92 0.26 0.00 0.23 0.00 0.00 3,939 34,058 15,267 1.29 0.36 0.00 0.33 0.00 0.00 18,523 160,153 71,793 6.07 1.71 0.02 1.55 0.00 0.00 266,561 2,304,673 1,033,129 87.42 24.64 0.24 22.25 0.00 0.00 3 27 12 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 2,192 18,956 8,497 0.72 0.20 0.00 0.18 0.00 0.00 15,639 135,214 60,613 5.13 1.45 0.01 1.31 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 12,420 107,385 48,138 4.07 1.15 0.01 1.04 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 1,484 4,678 27,289 1.17 0.29 0.00 0.18 0.00 0.00 1,000 3,154 18,396 0.79 0.20 0.00 0.12 0.00 0.00 9,765 30,789 179,605 7.70 1.92 0.01 1.20 0.00 0.00 7,773 24,510 142,977 6.13 1.53 0.01 0.95 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 6,942 21,889 127,684 5.47 1.37 0.01 0.85 0.00 0.00 24,008 75,701 441,591 18.93 4.73 0.03 2.94 0.00 0.00 20,550 64,797 377,981 16.20 4.05 0.03 2.52 0.00 0.00 62,801 198,021 1,155,121 49.51 12.38 0.08 7.70 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 7,785 24,547 143,193 6.14 1.53 0.01 0.95 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 4,906 15,468 90,230 3.87 0.97 0.01 0.60 0.00 0.00 6,976 21,998 128,320 5.50 1.37 0.01 0.86 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 19 60 349 0.01 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 1,984 17,154 7,690 0.65 0.18 0.00 0.17 0.00 0.00 3,163 27,351 12,261 1.04 0.29 0.00 0.26 0.00 0.00 4,500 38,904 17,440 1.48 0.42 0.00 0.38 0.00 0.00 15,109 130,631 58,559 4.95 1.40 0.01 1.26 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 0.00 0.00 0.00 0.00 0.00 0 0 0 0.00 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0 0 0 18,523 160,153 71,793 6 2 0 2 0 0 266,561 2,304,673 1,033,129 87 25 0 22 0 0 3 27 12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2,192 18,956 8,497 1 0 0 0 0 0 15,639 135,214 60,613 5 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 12,420 107,385 48,138 4 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1,484 4,678 27,289 1 0 0 0 0 0 1,000 3,154 18,396 1 0 0 0 0 0 9,765 30,789 179,605 8 2 0 1 0 0 7,773 24,510 142,977 6 2 0 1 0 0 0 0 0 0 0 0 0 0 0 6,942 21,889 127,684 5 1 0 1 0 0 24,008 75,701 441,591 19 5 0 3 0 0 20,550 64,797 377,981 16 4 0 3 0 0 62,801 198,021 1,155,121 50 12 0 8 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7,785 24,547 143,193 6 2 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 4,906 15,468 90,230 4 1 0 1 0 0 6,976 21,998 128,320 5 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 19 60 349 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1,984 17,154 7,690 1 0 0 0 0 0 3,163 27,351 12,261 1 0 0 0 0 0 4,500 38,904 17,440 1 0 0 0 0 0 15,109 130,631 58,559 5 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Sector Region coc BaseMed Baselar Bmed Blar Beef Central BeefCentral 0.10 1.00 0.10 1.00 Beef Mid AtlantiBeefMid Atlantic 0.04 1.00 0.04 1.00 Beef Midwest BeefMidwest 0.06 1.00 0.06 1.00 Beef Pacific BeefPacific 0.10 1.00 0.10 1.00 Beef South BeefSouth 0.04 0.00 0.04 0.00 Broiler Central BroilCentral 0.05 0.10 0.05 1.00 Broiler Mid AtlantiBroilMid Atlantic 0.05 0.10 0.05 1.00 Broiler Midwest BroilMidwest 0.05 0.10 0.05 1.00 Broiler Pacific BroilPacific 0.05 0.10 0.05 1.00 Broiler South BroilSouth 0.05 0.10 0.05 1.00 Dairy Central DairyCentral 0.20 1.00 0.20 1.00 Dairy Mid AtlantiDairyMid Atlantic 0.55 1.00 0.55 1.00 Dairy Midwest DairyMidwest 0.45 1.00 0.45 1.00 Dairy Pacific DairyPacific 0.10 1.00 0.10 1.00 Dairy South DairySouth 0.35 1.00 0.35 1.00 Heifer Central HeifeCentral 0.00 0.00 0.20 1.00 Heifer Mid AtlantiHeifeMid Atlantic 0.00 0.00 0.00 0.00 Heifer Midwest HeifeMidwest 0.00 0.00 0.45 0.00 Heifer Pacific HeifePacific 0.00 0.00 0.10 1.00 Heifer South HeifeSouth 0.00 0.00 0.00 0.00 Layer ( wet) Central LayerCentral 0.03 1.00 0.03 1.00 Layer Central LayerCentral 0.02 0.00 0.02 1.00 Layer ( wet) Mid AtlantiLayerMid Atlantic 0.03 1.00 0.03 1.00 Layer Mid AtlantiLayerMid Atlantic 0.02 0.00 0.02 1.00 Layer ( wet) Midwest LayerMidwest 0.03 1.00 0.03 1.00 Layer Midwest LayerMidwest 0.02 0.00 0.02 1.00 Layer ( wet) Pacific LayerPacific 0.03 1.00 0.03 1.00 Layer Pacific LayerPacific 0.05 0.00 0.05 1.00 Layer ( wet) South LayerSouth 0.03 1.00 0.03 1.00 Layer South LayerSouth 0.02 0.00 0.02 1.00 Swine Central SwineCentral 0.15 1.00 0.15 1.00 Swine Mid AtlantiSwineMid Atlantic 0.15 1.00 0.15 1.00 Swine Midwest SwineMidwest 0.15 1.00 0.15 1.00 Swine Pacific SwinePacific 0.15 1.00 0.15 1.00 Swine South SwineSouth 0.15 1.00 0.15 1.00 Turkey Central TurkeCentral 0.02 0.10 0.02 1.00 Turkey Mid AtlantiTurkeMid Atlantic 0.02 0.10 0.02 1.00 Turkey Midwest TurkeMidwest 0.02 0.10 0.02 1.00 Turkey Pacific TurkePacific 0.02 0.10 0.02 1.00 Turkey South TurkeSouth 0.05 0.10 0.05 1.00 Veal Central VealCentral 0.00 0.00 0.08 1.00 Veal Mid AtlantiVealMid Atlantic 0.00 0.00 0.12 1.00 Veal Midwest VealMidwest 0.00 0.00 0.12 1.00 Veal Pacific VealPacific 0.00 0.00 0.00 1.00 Veal South VealSouth 0.00 0.00 0.00 1.00


  SEQ CHAPTER \h \r 1

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[FRL                 ]

New Mexico: Final Authorization of State Hazardous Waste Management
Program Revisions

AGENCY: Environmental Protection Agency (EPA)

ACTION: Proposed rule

SUMMARY:   The State of New Mexico has applied to EPA for Final
authorization of the changes to its hazardous waste program under the
Resource Conservation and Recovery Act (RCRA).  EPA proposes to grant
Final Authorization to the State of New Mexico.  In the “Rules and
Regulations” section of this Federal Register, EPA is authorizing the
changes by an immediate final rule.  EPA did not make a proposal prior
to the immediate final rule because we believe this action is not
controversial and do not expect comments that oppose it. We have
explained the reasons for this authorization in the preamble to the
immediate final rule.  Unless we get written comments which oppose this
authorization during the comment period, the immediate final rule will
become effective on the date it establishes, and we will not take
further action on this proposal.  If we receive comments that oppose
this action, we will withdraw the immediate final rule and it will not
take effect.  We will then respond to public comments in a later final
rule based on this proposal.  You may not have another opportunity for
comment.  If you want to comment on this action, you must do so at this
time.

DATES:  Send your written comments by [insert date 30 days after the
date of publication in the FR].

ADDRESSES:  Send written comments to Alima Patterson, Region 6, Regional
Authorization Coordinator, (6PD-O), Multimedia Planning and Permitting
Division, at the address shown below.  You can examine copies of the
materials submitted by the State of New Mexico during normal business
hours at the following locations:  New Mexico Environment Department,
2905 Rodeo Park Drive East, Building 1, Santa Fe, New Mexico 87505-6303,
phone number<PHONE_NUMBER> and EPA, Region 6, 1445 Ross Avenue, Dallas,
Texas 75202-2733, phone number<PHONE_NUMBER>, comments may also be
submitted electronically or through hand delivery/courier; please follow
the detailed instructions in the ADDRESSES section of the immediate
final rule which is located in the Rules section of this Federal
Register.

FOR FURTHER INFORMATION CONTACT:  Alima Patterson<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

For additional information, please see the immediate final rule
published in the “Rules and Regulations” section of this Federal
Register.

Dated: October 12, 2010

BILLING CODE 6560-5-P

	____________________________

						                       Al Armendariz, Regional Administrator

							.

				  	 	            Region 6


[Federal Register: December 28, 2009 (Volume 74, Number 247)]
[Rules and Regulations]
[Page 68505-68508]
[DOCID:fr28de09-9]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1209; Directorate Identifier 2009-NM-151-AD;
Amendment 39-16147; AD 2008-04-11 R1]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Model 707 Airplanes,
and Model 720 and 720B Series Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is revising an existing airworthiness directive (AD),
which applies to all Model 707 airplanes, and Model 720 and 720B series
airplanes. That AD currently requires revising the FAA-approved
maintenance program by incorporating new airworthiness limitations
(AWLs) for fuel tank systems to satisfy Special Federal Aviation
Regulation No. 88 requirements. That AD also requires an initial
inspection to phase in certain repetitive AWL inspections, and repair
if necessary. This AD clarifies the intended effect of the AD on spare
and on-airplane fuel tank system components. This AD results from
design review of the fuel tank systems. We are issuing this AD to
prevent the potential for ignition sources inside fuel tanks caused by
latent failures, alterations, repairs, or maintenance actions, which,
in combination with flammable fuel vapors, could result in fuel tank
explosions and consequent loss of the airplane.

DATES: This AD is effective January 12, 2010.
    On March 28, 2008 (73 FR 9666, February 22, 2008), the Director of
the Federal Register approved the incorporation by reference of a
certain publication listed in the AD.
    We must receive any comments on this AD by February 11, 2010.

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 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Boeing
Commercial Airplanes, Attention: Data & Services Management, P.O. Box
3707, MC 2H-65, Seattle, Washington 98124-2207; telephone<PHONE_NUMBER>,
extension 1; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>Internet
https://www.myboeingfleet.com.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Thomas Thorson, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 917-6508; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    On February 13, 2008, we issued AD 2008-04-11, Amendment 39-15383
(73 FR 9666, February 22, 2008). That AD applied to all Model 707
airplanes, and Model 720 and 720B series airplanes. That AD required
revising the FAA-approved maintenance program by incorporating new
airworthiness limitations (AWLs) for fuel tank systems to satisfy
Special Federal Aviation Regulation No. 88 requirements. That AD also
required an initial inspection to phase in certain repetitive AWL
inspections, and repair if necessary. That AD resulted from a design
review of the fuel tank systems. The actions specified in that AD are
intended to prevent the potential for ignition sources inside fuel
tanks caused by latent failures, alterations, repairs, or maintenance
actions, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.
    Critical design configuration control limitations (CDCCLs) are
limitation requirements to preserve a critical ignition source
prevention feature of the fuel tank system design that is necessary to
prevent the occurrence of an unsafe condition. The purpose of a CDCCL
is to provide instruction to retain the critical ignition source
prevention feature during configuration change that may be caused by
alterations, repairs, or maintenance actions. A CDCCL is not a periodic
inspection.

Actions Since AD was Issued

    Since we issued that AD, we have determined that it is necessary to
clarify the AD's intended effect on spare and on-airplane fuel tank
system components, regarding the use of maintenance manuals and
instructions for continued airworthiness.
    Section 91.403(c) of the Federal Aviation Regulations (14 CFR
91.403(c)) specifies the following:

    No person may operate an aircraft for which a manufacturer's
maintenance manual or instructions for continued airworthiness has
been issued that contains an airworthiness limitation section unless
the mandatory * * * procedures * * * have been complied with.

Some operators have questioned whether existing components affected by
the new CDCCLs must be reworked. We did not intend for the AD to
retroactively require rework of components that had been maintained
using acceptable methods before the effective date of the AD. Owners
and operators of the affected airplanes therefore are not required to
rework affected components identified as airworthy or installed on the
affected airplanes before the required revisions of the FAA-approved
maintenance program. But once the CDCCLs are incorporated into the FAA-
approved maintenance program, future maintenance actions on components
must be done in accordance with those CDCCLs.

FAA's Determination and Requirements of This AD

    The unsafe condition described previously is likely to exist or
develop on other airplanes of the same type design. For this reason, we
are issuing this AD to revise AD 2008-04-11. This new AD retains the
requirements of the existing AD, and adds a new note to clarify the
intended effect of the AD on spare and on-airplane fuel tank system
components.

Explanation of Additional Changes to AD

    AD 2008-04-11 allowed the use of later revisions of the
airworthiness limitations. That provision has been removed from this
AD. Allowing the use of ``a later revision'' of specific service
documents violates Office of the Federal Register regulations for
approving materials that are incorporated by reference. Affected
operators, however, may request approval to use a later revision of the
referenced service documents as an alternative method of compliance,
under the provisions of paragraph (j) of this AD.
    In addition, we have revised this AD to identify the legal name of
the manufacturer as published in the most recent type certificate data
sheet for the affected airplane models.

Costs of Compliance

    This revision imposes no additional economic burden. The current
costs for this AD are repeated for the convenience of affected
operators, as follows:
    There are about 213 airplanes of the affected design in the
worldwide fleet. This AD affects about 76 airplanes of U.S. registry.
The required actions take about 8 work hours per airplane, at an
average labor rate of $80 per work hour. Based on these figures, the
estimated cost of the AD for U.S. operators is $48,640, or $640 per
airplane.

FAA's Justification and Determination of the Effective Date

    This revision merely clarifies the intended effect on spare and on-
airplane fuel tank system components, and makes no substantive change
to the AD's requirements. For this reason, it is found that notice and
opportunity for prior public comment for this action are unnecessary,
and good cause exists for making this amendment effective in less than
30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this AD. Send
your comments to an address listed under the ADDRESSES section. Include
``Docket No. FAA-2009-1209; Directorate Identifier 2009-NM-151-AD'' at
the beginning of your comments. We specifically invite comments on the
overall regulatory, economic, environmental, and energy aspects of this
AD. We will consider all comments received by the closing date and may
amend this AD because of 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 AD.

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 have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will 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 that the 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 AD and placed it in the AD docket. See the ADDRESSES
section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends part 39 of the Federal Aviation Regulations (14 CFR part
39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
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]

0
2. The FAA amends Sec.  39.13 by removing Amendment 39-15383 (73 FR
9666, February 22, 2008) and adding the following new AD:

2008-04-11 R1 The Boeing Company: Amendment 39-16147. Docket No.
FAA-2009-1209; Directorate Identifier 2009-NM-151-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective January 12,
2010.

Affected ADs

    (b) This AD revises AD 2008-04-11, Amendment 39-15383.

Applicability

    (c) This AD applies to all The Boeing Company Model 707-100 long
body, -200, -100B long body, and -100B short body series airplanes;
Model 707-300, -300B, -300C, and -400 series airplanes; and Model
720 and 720B series airplanes; certificated in any category.

    Note 1:  This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these inspections is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these limitations, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (j) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Unsafe Condition

    (d) This AD results from a design review of the fuel tank
systems. We are issuing this AD to prevent the potential for
ignition sources inside fuel tanks caused by latent failures,
alterations, repairs, or maintenance actions, which, in combination
with flammable fuel vapors, could result in fuel tank explosions and
consequent loss of the airplane.

Compliance

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

Restatement of Requirements of AD 2008-04-11, With Changes to
Compliance Method

Service Information

    (f) The term ``D6-7552-AWL March 2006,'' as used in this AD,
means Boeing 707/720 Airworthiness Limitations (AWLs) Document D6-
7552-AWL, dated March 2006.

Revision of AWLs Section

    (g) Before December 16, 2008, revise the FAA-approved
maintenance program by incorporating the information in the sections
specified in paragraphs (g)(1) through (g)(3) of this AD, except
that the initial inspection specified in paragraph (h) of this AD
must be done at the time specified in paragraph (h).
    (1) Section B., ``FUEL SYSTEMS AIRWORTHINESS LIMITATIONS,'' of
D6-7552-AWL March 2006.
    (2) Section C., ``SYSTEM AWL PAGE FORMAT,'' of D6-7552-AWL March
2006.
    (3) Section D., ``AIRWORTHINESS LIMITATIONS--FUEL SYSTEMS,'' of
D6-7552-AWL March 2006.

Initial Inspection and Repair if Necessary

    (h) At the later of the times specified in paragraphs (h)(1) and
(h)(2) of this AD: Do a detailed inspection of external wires over
the center fuel tank for damaged or loose clamps, wire chafing, and
wire bundles in contact with the surface of the center fuel tank, in
accordance with Section D, ``AIRWORTHINESS LIMITATIONS--FUEL
SYSTEMS,'' AWL 28-AWL-01, of D6-7552-AWL March 2006. If any
discrepancy is found during this inspection, repair the discrepancy
before further flight in accordance with D6-7552-AWL March 2006.
Accomplishing AWL 28-AWL-01 as part of an FAA-approved maintenance
program prior to the later of the times specified in paragraphs
(h)(1) and (h)(2) of this AD constitutes compliance with the
requirements of this paragraph.
    (1) Before the accumulation of 36,000 total flight cycles, or
within 120 months since the date of issuance of the original
standard airworthiness certificate or the date of issuance of the
original export certificate of airworthiness, whichever occurs
first.
    (2) Within 72 months after March 28, 2008 (the effective date of
AD 2008-04-11).

    Note 2:  For the purposes of this AD, a detailed inspection is:
``An intensive examination of a specific item, installation, or
assembly to detect damage, failure, or irregularity. Available
lighting is normally supplemented with a direct source of good
lighting at an intensity deemed appropriate. Inspection aids such as
mirror, magnifying lenses, etc., may be necessary. Surface cleaning
and elaborate procedures may be required.''

No Alternative Inspections, Inspection Intervals, or Critical Design
Configuration Control Limitations (CDCCLs)

    (i) After accomplishing the actions specified in paragraphs (g)
and (h) of this AD, no alternative inspections, inspection
intervals, or CDCCLs may be used unless the inspections, intervals,
or CDCCLs are approved as an alternative method of compliance (AMOC)
in accordance with the procedures specified in paragraph (j) of this
AD.

New Information

Explanation of CDCCL Requirements

    Note 3:  Notwithstanding any other maintenance or operational
requirements, components that have been identified as

airworthy or installed on the affected airplanes before the revision
of the FAA-approved maintenance program, as required by paragraph
(g) of this AD, do not need to be reworked in accordance with the
CDCCLs. However, once the FAA-approved maintenance program has been
revised, future maintenance actions on these components must be done
in accordance with the CDCCLs.

Alternative Methods of Compliance (AMOCs)

    (j)(1) The Manager, Seattle Aircraft Certification Office
(SACO), FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Thomas Thorson, Aerospace Engineer, Propulsion
Branch, ANM-140S, FAA, SACO, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Or, e-mail information to<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (3) AMOCs approved previously in accordance with AD 2008-04-11,
Amendment 39-15383, are approved as AMOCs for the corresponding
provisions of this AD.

Material Incorporated by Reference

    (k) You must use Boeing 707/720 Airworthiness Limitations (AWLs)
Document D6-7552-AWL, including attachment, dated March 2006, to do
the actions required by this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register previously approved the
incorporation by reference of Boeing 707/720 Airworthiness
Limitations (AWLs) Document D6-7552-AWL, including attachment, dated
March 2006, on March 28, 2008 (73 FR 9666, February 22, 2008).
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (3) You may review copies of the 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> or<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on December 16, 2009.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-30564 Filed 12-24-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Page 73829]
[FR Doc No: 2020-25507]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90428/November 13, 2020]

Securities Exchange Act of 1934; In the Matter of: Cboe BZX
Exchange, Inc., 400 South LaSalle Street, Chicago, IL 60605, File No.
SR-CboeBZX-2018-044; Order Setting Aside the Order by Delegated
Authority Disapproving SR-CboeBZX-2018-044

    On June 21, 2018, Cboe BZX Exchange, Inc. (``BZX'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule
change to amend BZX Rule 14.11(c) to permit either the portfolio
holdings of a series of Index Fund Shares or the index underlying a
series of Index Fund Shares to satisfy the listing standards under BZX
Rules 14.11(c)(3), (4), and (5). The proposed rule change was published
for comment in the Federal Register on July 11, 2018.\3\ On August 23,
2018, the Division of Trading and Markets (``Division''), for the
Commission pursuant to delegated authority, extended the time period
for Commission action on the proposed rule change.\4\ On September 28,
2018, the Exchange filed Amendment No. 1 to the proposed rule change,
which amended and replaced the proposed rule change as originally
filed.\5\ On October 5, 2018, the Division, for the Commission pursuant
to delegated authority, published notice of Amendment No. 1 and
instituted proceedings pursuant to Section 19(b)(2)(B) of the Exchange
Act \6\ to determine whether to approve or disapprove the proposed rule
change, as modified by Amendment No. 1.\7\ On December 21, 2018,
pursuant to Section 19(b)(2) of the Exchange Act,\8\ the Division, for
the Commission pursuant to delegated authority, designated a longer
period within which to issue an order approving or disapproving the
proposed rule change, as modified by Amendment No. 1.\9\ On March 8,
2019, the Division, for the Commission pursuant to delegated
authority,\10\ disapproved the proposed rule change, as modified by
Amendment No. 1.\11\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 83594 (July 5,
2018), 83 FR 32158.
    \4\ See Securities Exchange Act Release No. 83919, 83 FR 44083
(August 29, 2018).
    \5\ Amendment No. 1 is available at https://www.sec.gov/comments/sr-cboebzx-2018/044/srcboebzx2018044/4468884/175849.pdf.
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 84378, 83 FR 51745
(October 12, 2018).
    \8\ 15 U.S.C. 78s(b)(2).
    \9\ See Securities Exchange Act Release No. 84948, 83 FR 67785
(December 31, 2018).
    \10\ 17 CFR 200.30-3(a)(12).
    \11\ See Securities Exchange Act Release No. 85278, 84 FR 9395
(March 14, 2019) (``Delegated Order'').
---------------------------------------------------------------------------

    On March 18, 2019, the Acting Secretary of the Commission notified
BZX that, pursuant to Commission Rule of Practice 431,\12\ the
Commission would review the Division's action pursuant to delegated
authority and that the Division's action pursuant to delegated
authority was stayed until the Commission orders otherwise.\13\ On
April 17, 2019, the Commission issued a scheduling order allowing the
filing of additional statements.\14\
---------------------------------------------------------------------------

    \12\ 17 CFR 201.431.
    \13\ See letter from Vanessa A. Countryman, Acting Secretary,
Commission, to Kyle Murray, Assistant General Counsel, BZX, dated
March 18, 2019, available at https://www.sec.gov/rules/sro/cboebzx/2019/cboebzx-2018-044-acknowledgement-letter-031819.pdf.
    \14\ See Securities Exchange Act Release No. 85682, 84 FR 18098
(April 29, 2019).
---------------------------------------------------------------------------

    On June 23, 2020, BZX withdrew the proposed rule change (SR-
CboeBZX-2018-044).\15\
---------------------------------------------------------------------------

    \15\ See letter from Kyle Murray, Vice President and Associate
General Counsel, BZX, to Vanessa Countryman, Secretary, Commission,
dated June 23, 2020, available at https://www.sec.gov/comments/sr-cboebzx-2018-044/srcboebzx2018044-7340745-218668.pdf.
---------------------------------------------------------------------------

    Under Commission Rule of Practice 431(a), the Commission may
``affirm, reverse, modify, set aside or remand for further proceedings,
in whole or in part, any action made pursuant to'' delegated
authority.\16\ We find that, in light of BZX's withdrawal of the
proposed rule change, it is appropriate to set aside the Delegated
Order.
---------------------------------------------------------------------------

    \16\ 17 CFR 201.431(a).
---------------------------------------------------------------------------

    Accordingly, it is ordered that the March 8, 2019 order
disapproving by delegated authority BZX's proposed rule change number
SR-CboeBZX-2018-044, be, and it hereby is, set aside.

    By the Commission.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-25507 Filed 11-18-20; 8:45 am]
BILLING CODE 8011-01-P


Significant New Alternatives Policy Program
Refrigeration and Air Conditioning Sector
Risk Screen on Substitutes for CFC-113 in Non-Mechanical Heat Transfer

               Substitute: C7 Fluoroketone (C7 FK or FK-6-1-14)
This risk screen does not contain Clean Air Act (CAA) Confidential Business Information (CBI) and, therefore, may be disclosed to the public.
1. 	INTRODUCTION
Ozone-depleting substances (ODS) are being phased out of production in response to a series of diplomatic and legislative efforts that have taken place over the past decade, including the Montreal Protocol and the Clean Air Act Amendments of 1990 (CAAA).  The U.S. Environmental Protection Agency (EPA), as authorized by Section 612 of the CAAA, administers the Significant New Alternatives Policy (SNAP) Program, which identifies acceptable and unacceptable substitutes for ODS in specific end-uses based on assessment of their health and environmental impacts.

EPA's decision on the acceptability of a substitute is based largely on the findings of a screening assessment of potential human health and environmental risks posed by the substitute in specific applications.  EPA has already screened a large number of substitutes in many end uses within all of the major ODS-using sectors, including refrigeration and air conditioning, solvent cleaning, foam blowing, aerosols, fire suppression, adhesives, coatings and inks, and sterilization. The results of these risk screens are presented in a series of Background Documents that are available in EPA's docket.
The purpose of this risk screen is to supplement EPA's Background Document on the refrigeration and air conditioning sector (EPA 1994) (hereinafter referred to as the Background Document). This risk screen evaluates the potential use of C7 Fluoroketone (also referred to as FK-6-1-14 or C7 FK) as a substitute for CFC-113 to be used as a non-mechanical heat transfer fluid. As indicated by the submitter, C7 FK is intended for use in organic Rankine cycles (ORC) and in direct immersion cooling. Table 1 presents information on the proposed substitute.
                         Table 1. Composition of C7 FK
                                  Constituent
                               Chemical Formula
                                  CAS Number
                               Percent of Total
                                (by weight)[a]
        3-Pentanone,1,1,1,2,4,5,5,5-octafluoro-2,4-bis(trifluoromethyl)
                                    C7F14O
                                   813-44-5
                                    55-65%
       3-Hexanone,1,1,1,2,4,4,5,5,6,6,6-undecafluoro-2-(trifluoromethyl)
                                    C7F14O
                                   813-45-6
                                    35-45%
  .

The potential risks associated with use of substitutes in non-mechanical heat transfer have been examined at length in the Background Document.  The reader is referred to this reference for a detailed discussion of the methodologies used to conduct this risk screen. This risk screen addresses flammability risk and occupational exposure modeling was performed to ensure that use of the proposed substitute did not pose unacceptable risk to workers during equipment manufacture. Modeling was performed at the end-use to ensure that potential releases of the substitute did not pose unacceptable risk to those responsible for filling and maintenance of the heat transfer units where the substitute is intended for use. General population exposure is not expected to occur.

Section 2 of this report summarizes the results of the risk screen for the proposed substitute.  The remainder of the report is organized into the following sections:
         * Section 3: Atmospheric Assessment
         * Section 4: Flammability Assessment
         * Section 5: Potential Health Effects
         * Section 6: Occupational Exposure Assessment
         * Section 7: End-Use Exposure Assessment
         * Section 8: General Population Exposure Assessment
         * Section 9: Volatile Organic Compound Assessment
         * Section 10: References
2. 	SUMMARY OF RESULTS
Use of C7 FK as a non-mechanical heat transfer fluid is not expected to pose a significant risk to atmospheric integrity or to the health of the general population, and is therefore recommended for SNAP approval for the proposed end-use. Given that proper training will be given to personnel and that appropriate personal protective equipment (PPE) (Occupational Safety & Health Administration [OSHA] Category D or higher) and proper procedures according to the MSDS (including provisions of adequate ventilation) will be used during manufacturing, end-use, and disposal, no risk to workers, end-users, or the general population is anticipated. In addition, this risk screen indicates that the use of the proposed substitute will be less harmful to the atmosphere than the continued use of CFC-113, perfluorohexanes, and HFC-245fa.

3. 	ATMOSPHERIC ASSESSMENT
This section presents an assessment of the potential risks to atmospheric integrity posed by the use of C7 FK as a non-mechanical heat transfer fluid.  The ODP, GWP, and ALT of the proposed substitute are presented in Table 2.  The substitute is substantially less harmful to the ozone layer and has less climate impact than CFC-113. In addition, its low GWP relative to other non-ODS heat transfer fluids will provide environmental benefit compared to other available options.

Table 2.  Atmospheric Impacts of C7 FK Compared to CFC-113 and Other Intended Non-ODS Replacements
                              Heat Transfer Fluid
                                      ODP
                                      GWP
                                  ALT (years)
                                     C7 FK
                                     0[a]
                                     1[a]
                                   7 days[a]
                                    CFC-113
                                    0.8[b]
                                   6,130[c]
                                     85[c]
                                   C6F14[e]
                                       0
                                   9,140[d]
                                   3,200[d]
                                   HFC-245fa
                                       0
                                   1,020[d]
                                    7.6[d]
                                    Pentane
                                       0
                                     11[a]
                                   8 days[f]
   a  3M Submission 2011
   [b] Available at: http://www.epa.gov/ozone/ods.html.
   [c] IPCC 4th Assessment Report (Forster et al. 2007).
   [d] Available at: http://www.epa.gov/ozone/geninfo/gwps.html
   [e] Perfluorohexanes are acceptable in heat transfer applications where no other substitutes are feasible
   [f] Available at: http://www1.chem.leeds.ac.uk//Atmospheric/Field/campaigns/ARCICE/arcicepaper.pdf

4. 	FLAMMABILITY ASSESSMENT
C7 FK is not flammable, and therefore, a flammability assessment was not performed (3M C7 FK SNAP Submission, 2001).
5. 	POTENTIAL HEALTH EFFECTS
According to the MSDS, exposure to C7 FK above the exposure guideline may result in potentially harmful health effects. Inhalation of C7 FK could cause respiratory tract irritation and symptoms may include cough, sneezing, nasal discharge, headache, hoarseness, and nose and throat pain. If thermal decomposition of the compound occurs, inhalation of the decomposition products may also be harmful. If overexposure due to inhalation of C7 FK above the exposure guideline occurs, person(s) should be immediately removed and exposed to fresh air and medical attention should be sought if the abovementioned symptoms develop. Contact with the eyes and skin during product use is not expected to result in significant irritation. Ingestion of C7 FK is not expected to cause health effects, and there is no anticipated need for first aid if ingestion of C7 FK occurs (3M 2011b). EPA's review of the environmental and human health impacts of this proposed substitute is contained in the public docket for this decision.

When good industrial hygiene practices and the PPE and engineering control (e.g., ventilation) recommendations outlined in the MSDS for C7 FK, as summarized in Sections 6 and 7 of this risk screen, are followed, these potential health effects are unlikely to occur.
6. 	OCCUPATIONAL EXPOSURE ASSESSMENT
C7 FK is manufactured in a closed system. According to the submitter, workers may be exposed to C7 FK during the manufacture of the product during direct line filling of drums and containers for offsite delivery, as well as during filling of heat transfer units. The potential for personnel exposure during manufacture and installation and maintenance are examined in this section. ICF's estimated acceptable exposure limit (AEL) for C7 FK is 225 ppm (3368 mg/m[3]) averaged over an 8-hour time period (8-hour TWA).  The AEL was derived using an interspecies uncertainty factor of 3 and an uncertainty factor of 3 to compensate for uncertainty in the database -- i.e., use of a 28-day, rather than a 90-day subchronic or 2-year chronic study to develop the 8-hour AEL. The reader is referred to Appendix A for a detailed explanation of the development of the AEL.  The substitute's manufacturer also recommends an AEL of 225 ppm (8-hr TWA) for C7 FK.
6.1	Occupational Exposure during Manufacture
For small to moderate spills of C7 FK (< 100 kg), it is recommended that the area in which the spill occurs be cleared of personnel until ambient concentrations return to acceptable levels. The submitter modeled two scenarios to determine the appropriate reentry time in case of a spill. In both scenarios, the ventilation rate was fixed at 6 air changes per hour (ACH) and 4.5 kg of C7 FK was released to simulate a small leak (see Table 3) (3M 2011a).

                        Table 3. C7 FK Spill Monitoring
                             Scenario Room Volume
                              Peak Concentration
                                 Reentry Time
                                   100 m[3]
                                   2,200 ppm
                                    28 min
                                   1000 m[3]
                                    225 ppm
                                   Immediate

It is recommended that each manufacturing facility has the appropriate staff and resources to design the appropriate working environment and adhere to reentry time guidance following a leak of the substance. The submitter concludes that factory production of the C7 FK using the same procedures for C6 FK would result in short term worker exposure of less than 1 ppm for C7 FK. In addition, personal protective equipment (PPE), as suggested in the MSDS, is recommended for workers dealing with C7 FK in industrial settings.
6.2	Occupational Exposure during Installation and Maintenance
To address the potential employee exposure to C7 FK of larger spills associated with installation and maintenance, the submitter provided surrogate air monitoring studies for a C6 fluorinated ketone (C6 FK or Novec(TM) 1230) analog. Air concentrations found during the air monitoring studies with a C6 FK (described below) would be a conservative estimate of air concentrations of C7 FK, due to the higher boiling point and vapor pressure of C7 FK (see Table 4) (3M Novec(TM) 1230 SNAP Submission, 2001).

     Table 4. Boiling Point and Vapor Pressure for C7 FK and C6 FK Analog
Parameter
                           C7 FK Proposed Substitute
                                 C6 FK Analog
Boiling Point
                                     74 C
                                     49 C
Vapor Pressure
                              125 mmHg (at 20 C)
                              244 mmHg (at 20 C)

According to the submitter, monitoring was conducted in two scenarios to determine the concentration of C6 FK during installation and maintenance operations, which are reflective of the conditions for either draining the reactor or draining to drums post purification to prepare for offsite delivery of the proposed substitute. The first scenario modeled was tote filling, and monitoring was conducted without local exhaust which resulted in an area TWA concentration of 60 ppm. The peak instantaneous concentration for this scenario was 300 ppm, which is above the recommended AEL of 225 ppm over an 8 hour period; however, this scenario was modeled without the use of local exhaust. The second scenario, drum filling, was performed with local exhaust and resulted in personal TWA exposure of 1.3 ppm. Table 5 shows the additional results of the air monitoring.

                     Table 5. C6 FK Air Monitoring Results
Scenario
                              Peak Concentration
                            Area TWA Concentration
Tote Filling -- no local exhaust
                                    300 ppm
                                    60 ppm
Drum Filling-with local exhaust
                                   11.7 ppm
                                    1.3 ppm

The submitter concludes that factory production of the C7 FK using the same C6 FK procedures would result in short term worker exposure of less than 1 ppm for C7 FK, which is much lower than the AEL of 225 ppm for C7 FK. Therefore, toxicity risks due to use of C7 FK are expected to be minimal.  The submitter has recommended use of OSHA Category D or higher PPE such as safety glasses with side shields and neoprene, nitrile rubber, or polymer laminate gloves for workers dealing with C7 FK in industrial settings and that good ventilation, such as that provided by local exhaust fans, is in place. All spills should be cleaned up immediately in accordance with good industrial hygiene practices and the MSDS for C7 FK. In addition, all technicians should be properly trained in working with the transformers and related recovery equipment and possess EPA section 608 technician certification.
7.	END-USE EXPOSURE ASSESSMENT
The submitter also performed a study to simulate drum to drum transfer of C6 FK that would be reflective of conditions that may occur under customer use for filling or top-off of heat transfer equipment. In the most conservative scenario, in which no vapor return line was used and no room ventilation was running, the maximum concentration was 60 ppm, with an average concentration of 54 ppm. If the same study was performed with C7 FK, the leak concentrations would be even lower due to the nature of C7 FK's physical properties (see Table 4).  The substitute is proposed for use in hermetically sealed systems that are operated near atmospheric pressure. Any exposure scenario would occur infrequently and would result in very low emissions.
8. 	GENERAL POPULATION EXPOSURE ASSESSMENT
C7 FK is not expected to cause a significant risk to human health in the general population when used as a non-mechanical heat transfer fluid. The substitute is proposed for use in closed systems that are operated near atmospheric pressure. General population exposures to ambient air and surface water releases are not expected from this end use.
9. 	VOLATILE ORGANIC COMPOUND ASSESSMENT
C7 FK has not been exempted as a volatile organic compound (VOC) under the CAA (40 CFR 51.000). However, through standard industry practices, VOC emissions should be controlled.  The submitter intends to manufacture C7 FK for two heat transfer applications: organic rankine cycle (ORC) and direct immersion cooling systems. Using leak estimates from the Vintaging Model for ORC, which is expected to be used for geothermal heat recovery and plant-based heat recovery, the annual release rate -- including operating, servicing, and disposal leak rates -- for ORC applications was found to be approximately 1%. Direct immersion cooling is only used in highly specialized electronic applications with clean, controlled environments. This application is expected to have very low VOC emissions, and a 1% release rate is assumed. Assuming a 1% release rate for both applications, an assessment was performed to compare the annual VOC emissions from use of C7 FK in heat transfer applications in one year to other anthropogenic sources of VOC emissions. Assuming the portion for heat transfer applications of the submitter's maximum allowable annual production, only approximately 3.3x10[-3] percent of the VOC emissions caused by the generation of electricity in the United States, or only approximately 1.2x10[-5] percent of all anthropogenic VOC emissions in the U.S. would be released from the charged equipment. Moreover, even if the entire portion for heat transfer applications of the allowable quantity of C7 FK produced by the submitter in one year was all released to the atmosphere (extremely unlikely), the resulting annual VOC emissions would be approximately equal to 0.24 percent of annual VOC emissions caused by the generation of electricity in 2010, or approximately 8.2x10[-][4] percent of all annual anthropogenic VOC emissions.  As these emissions are several orders of magnitude less than other anthropogenic emissions, and because heat transfer equipment is hermetically sealed, the environmental impacts of these VOCs are not considered a significant risk.

.

10.	REFERENCES
3M 2001.  SNAP Submission to EPA for Novec 1230.  January 3, 2001.

3M 2010a. SNAP Addendum to EPA for C7 FK. February 22, 2010.

3M 2010b. P-10-135  -  C7 FK (Fluoroketone) teleconference EPA/3M Summary. November 22, 2010.

3M 2011a. Response to Incomplete SNAP submission for Fluoroketone. February 17, 2011.

3M 2011b. Material Safety Data Sheet  -  L-20154 Development Material. Issued August 11, 2011.

EIA 2010. Summary Statistics for the U.S. (Electric Power Industry), 1998 through 2009. Last updated, April 2011. Accessed October 3, 2011.

EPA 1994. Significant New Alternatives Policy Technical Background Document:  Risk Screen on the Use of Substitutes for Class I Ozone-depleting Substances: Refrigeration and Air Conditioning. U.S. Environmental Protection Agency, March 1994.

EPA 2009.  Volatile Organic Compounds  -  National Summary of VOC Emissions.  Last updated 04 November 2009.  Accessed 16 May 2011. Available at <http://www.epa.gov/air/emissions/voc.htm>.

ICF 2011.  Determination of an Acceptable Exposure Limit for C7 Fluoroketone.  May 2011.

                                  Appendix A
              Determination of an AEL for C7 Fluoroketone (C7 FK)

Recommended AEL: 		225 ppm (8-hour)

Basis and Endpoints: 		NOAEL 3000 ppm for male rats

Study: 	Sub acute (29-day) Inhalation Toxicity Study with MTDID 10800 in Rats

Protocol:	6 hours/day, 5 days/week for 4 weeks (whole body exposure)

Concentrations:			0; 3,000; 7,500; 15,000 ppm

NOAEL:	3,000 ppm (males) (excluding peroxisomal proliferation)

Uncertainty Factor:	10 (3 - interspecies extrapolation; 3  -  use of a sub-acute study)

AEL 	225 ppm (= 3,000 * 6 hours (exposure of rats)/8 hours (workday))* (1/10)

Derivation of a preliminary AEL for C7 FK relies on the reported NOAEL of 3,000 ppm for male Wistar rats from the 29-day inhalation study at exposure doses of 0, 3,000, 7,500, and 15,000 ppm (Muijser and Staal, 2008).  The only exposure-related effects of note in male rats were peroxisomal proliferation in liver cells at all exposure concentrations, and a significant increase in hepatocellular hypertrophy, as well as significant increases in the number of total white blood cells, lymphocytes, and neutrophils at 7,500 and 15,000 ppm.  No other effects in males were found by histological examination.  All the reported effects were found to be reversed in a separate group of recovery males who were held for 13-days post exposure.  No exposure-related effects were noted in female rats at any concentration; thus the NOAEL for females was identified as 15,000 ppm.  Peroxisomal proliferation is common in male rats which have been exposed to certain toxicants, and the effect has been debated within the risk assessment community with regard to predicting liver toxicity in humans (Keshava and Caldwell 2006; Melnick 2001).  The study authors discounted the peroxisomal proliferation, and identified a NOAEL of 3,000 ppm based on other mild responses at the mid- and high concentrations.  ICF agrees with this decision, particularly given the reversibility of the effects and given the similarity in the toxicity of C7 FK with the structurally similar C6 FK.

 Compensation for 6 hour/day exposure for 5 days/week is accomplished by multiplying the AEL of 3,000 ppm by a factor of 0.75 (6 hour study exposure/ 8 hour typical worker exposure) to obtain a Human Equivalent Concentration (HEC) of 2,250 ppm. An interspecies uncertainty factor of 3 is used to account for the pharmacodynamic differences between rats and humans. An additional uncertainty factor of 3 is recommended to compensate for use of a 29-day, rather than 90-day subchronic or 2-year chronic, study to develop the 8-hour AEL. The supporting toxicological data for C6 fluorinated ketone (C6 FK), which is structurally similar to C7 FK, precludes the need for an additional UF for the quality of the database.  Division of the HEC by 10 (multiplicative value of uncertainty factors) produces a derived AEL for C7 fluorinated ketone of 225 ppm.
References

Keshava N and JC Caldwell (2006) Key issues in the role of peroxisome proliferator-activated receptor agonism and cell signaling in trichloroethylene toxicity.  Environ Health Perspect 114(9):1464-1470.
Melnick RL (2001) Is peroxisome proliferation an obligatory precursor step in the carcinogenicity of di(2-ethylhexyl)phthalate (DEHP)? Environ Health Perspect 109(5):437-442.

Muijser H. and Staal YCM. (2008) Sub-acute (29-day) inhalation toxicity study with MTDID 10800 in rats. TNO Quality of Life, The Netherlands, for 3M Company, St Paul, MN 17 December


[Federal Register Volume 78, Number 6 (Wednesday, January 9, 2013)]
[Rules and Regulations]
[Pages 1739-1742]
[FR Doc No: 2012-31682]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0632; Directorate Identifier 2011-SW-044-AD;
Amendment 39-17305; AD 2012-26-10]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Eurocopter France (Eurocopter) Model SA-365N, SA-365N1, AS-365N2, AS
365 N3, EC 155B, EC155B1, SA-365C, SA-365C1, SA-365C2, and SA-366G1
helicopters. This AD requires inspecting portions of the main gearbox
(MGB) for the presence of sealing compound and corrosion. This AD was
prompted by reports of corrosion on the main MGB casing lower area
between the two servo-control anchoring fitting attachment ribs. An
investigation determined that the corrosion was associated with sealing
compound on the lower part of the fitting/casing attachment. The
actions in this AD are intended to detect corrosion on the MGB casing,
which could lead to a crack, failure of the MGB, and subsequent loss of
control of the helicopter.

DATES: This AD is effective February 13, 2013.

    The Director of the Federal Register approved the incorporation by
reference of certain documents listed in this AD as of February 13,
2013.

ADDRESSES: For service information identified in this AD, contact
American Eurocopter Corporation, 2701 Forum Drive, Grand Prairie, Texas
75053-4005, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, or at http://www.eurocopter.com. You may review the referenced service information
at the FAA, Office of the Regional Counsel, Southwest Region, 2601
Meacham Blvd., Room 663, Fort Worth, Texas 76137.

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 AD, any incorporated-by-reference
service information, the economic evaluation, any comments received,
and other information. The street address for the Docket Operations
Office (phone:<PHONE_NUMBER>) is U.S. Department of Transportation,
Docket Operations Office, M-30, West Building Ground Floor, Room W12-
140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Rao Edupuganti, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On June 18, 2012, at 77 FR 36220, the Federal Register published
our notice of proposed rulemaking (NPRM), which proposed to amend 14
CFR part 39 to include an AD that would apply to Eurocopter Model SA-
365N, SA-365N1, AS-365N2, AS 365 N3, EC 155B, EC155B1, SA-366G1, SA-
365C, SA-365C1, and SA-365C2 helicopters, with an MGB installed. That
NPRM proposed to require inspecting the lower parts of the MGB casing
anchoring fittings for sealing compound, and if there is sealing
compound on the lower parts of the anchoring fittings, removing the
sealing compound and inspecting the anchoring fittings for corrosion.
If there is corrosion, the NPRM proposed repairing the affected area.
If there is no corrosion, the NPRM proposed applying touch up
protective treatment and renewing any damaged sealing compound bead in
the lower part of the anchoring fitting.
    The proposed requirements were intended to detect corrosion on the
MGB casing, which could lead to a crack, failure of the MGB, and
subsequent loss of control of the helicopter.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued AD No.:
2011-0127, dated July 1, 2011 (AD No. 2011-0127), which supersedes
Directorate General for Civil Aviation (DGAC France) AD F-2008-04,
dated June 4, 2008, for the Eurocopter Model EC 155 B, EC 155 B1, SA
365 N, SA 365 N1, AS 365 N2, AS 365 N3, SA 366 G1, SA 365 C, SA 365 C1,
SA 365 C2, and SA 365 C3 helicopters with a MGB, all part numbers, that
was delivered before December 5, 2007, installed on helicopters
delivered before December 5, 2007, or overhauled or repaired before
September 30, 2008. EASA states that in 2008, it received two reports
of atmospheric corrosion on the MGB casing lower area of two
helicopters between the two servo-control anchoring fitting attachment
ribs. The investigation showed that the corrosion occurred in this area
due to the presence of ``PR sealing compound'' on the lower part of the
fitting/casing attachment. The ``PR sealing compound'' may have been
applied incorrectly on some helicopters due to a misinterpretation of
the Eurocopter documentation during installation. EASA states that this
condition, if not corrected, could lead to ``crack initiation and crack
growth in the affected area of the casing,'' which could cause this
area to fail and result in loss of control of the helicopter.

Comments

    We gave the public the opportunity to participate in developing
this AD, but we did not receive any comments on the NPRM (77 FR 36220,
June 18, 2012).

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, its technical
representative, has notified us of the unsafe condition described in
the EASA AD. We are issuing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other helicopters of these same
type designs and that air safety and the public interest require
adopting the AD requirements as proposed, except we have removed the
words ``with a main gearbox installed'' from the applicability
paragraph because that language is unnecessary. This minor change is
consistent with the intent of the proposals in the NPRM and will not
increase the economic burden on any operator nor increase the scope of
the AD.

Differences Between This AD and the EASA AD

    The EASA AD requires inspecting the anchoring fittings for ``PR
sealing compound'' within 15 flight hours, while this AD requires
inspecting within 30 hours TIS. The EASA AD applies to the Model SA-
365C3, and this AD does not include this model because it does not have
an FAA-issued type certificate. This AD does not allow the compliance
times provided in Appendix 1 of the EASA AD, since it is desirable to
accomplish any required repairs before further flight.

Related Service Information

    Eurocopter has issued one Emergency Alert Service Bulletin (EASB),
Revision 0, dated May 7, 2008, with five different numbers. EASB No.
63.00.17 is for the Model AS 365-series helicopters; EASB No. 63.00.12
is for the military Model AS 565-series helicopters, which are not FAA
type certificated; EASB No. 63A011 is for the Model EC 155-series
helicopters; EASB No. 65.03 is for the Model SA 366-series helicopters;
and EASB No. 65.47 is for the Model SA 365-series helicopters and the
non-FAA type certificated Model SA 360-series helicopters. The EASB
specifies inspecting for ``PR sealing compound'' on the lower parts of
the MGB anchoring fittings, removing any ``PR sealing compound,'' and
repairing any corrosion. EASA classified this EASB as mandatory and
issued AD No. 2011-0127 to ensure the continued airworthiness of these
helicopters.

Costs of Compliance

    We estimate that this AD will affect 31 helicopters of U.S.
Registry. We estimate that operators may incur the following costs in
order to comply with this AD. Inspecting the anchor fittings for
sealing compound and corrosion will require about 0.5 work hour at an
average labor rate of $85 per hour, for a cost per helicopter of about
$43 and a cost to the entire U.S. fleet of $1,318. Removing any sealing
compound and repairing any corrosion damage will require about 8 work
hours at an average labor rate of $85 per hour, for a cost per
helicopter of $680.

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 helicopters identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979);
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction; and
    (4) 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 an economic evaluation of the estimated costs to comply
with this 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.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
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]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2012-26-10 Eurocopter France Helicopters: Amendment 39-17305; Docket
No. FAA-2012-0632; Directorate Identifier 2011-SW-044-AD.

(a) Applicability

    This AD applies to Eurocopter France (Eurocopter) Model SA-365N,
SA-365N1, AS-365N2, AS 365 N3, EC 155B, EC155B1, SA-366G1, SA-365C,
SA-365C1, and SA-365C2 helicopters, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as corrosion on the main
gearbox (MGB) casing lower area between the servo-control anchoring
ribs, caused by sealing compound on the lower part of the fitting/
casing attachment. This condition could result in a crack, failure
of the MGB, and subsequent loss of control of the helicopter.

(c) Effective Date

    This AD becomes effective February 13, 2013.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) Within 30 hours time-in-service, inspect the lower parts of
the MGB servo-control anchoring fittings (anchor fittings) for
sealing compound, referring to Figure 1 of Eurocopter Emergency
Alert Service Bulletin No. 63.00.17 (for Models SA-365N, SA-365N1,
AS-365N2 and AS 365 N3); No. 63A011 (for Models EC 155B and
EC155B1); No. 65.03 (for Model SA-366G1); and No. 65.47 (for Models
SA-365C, SA-365C1, and SA-365C2), Revision 0, dated May 7, 2008
(EASB).

    Note 1 to paragraph (e)(1):  The Eurocopter EASB is one document
with multiple EASB numbers, each applicable to different base model
Eurocopter helicopters.

    (2) If there is sealing compound on the lower part of an MGB
anchor fitting, remove the sealing compound and inspect for
corrosion in the lower area of the MGB casing.
    (i) If there is corrosion, before further flight, repair the
corrosion area.
    (ii) If there is no corrosion, apply touch up protective
treatment, if required, and renew the bead of any damaged sealing
compound in the upper part of the anchor fitting.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Rao Edupuganti, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, Texas 76137; telephone (817) 222-
4389; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    (1) Eurocopter Repair Sheet 365-63-36-08, dated April 4, 2008,
and Standard Practices Manual (MTC) Work Cards 20.04.04, 20.04.05,
and 20.05.01, which are not incorporated by reference, contain
additional information regarding the subject of this AD and in
particular regarding the procedures for corrosion repair, protective
treatment touch-up, and renewing the damaged sealing bead. For
service information identified in this AD, contact American
Eurocopter Corporation, 2701 Forum Drive, Grand Prairie, Texas
75053-4005, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, or at
http://www.eurocopter.com. You may review a copy of the service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas 76137.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency AD No. 2011-0127, dated July 1, 2011.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6320: Main Rotor
Gearbox.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Eurocopter Emergency Alert Service Bulletin No. 63.00.17,
Revision 0, dated May 7, 2008.
    (ii) Eurocopter Emergency Alert Service Bulletin No. 63A011,
Revision 0, dated May 7, 2008.
    (iii) Eurocopter Emergency Alert Service Bulletin No. 65.03,
Revision 0, dated May 7, 2008.
    (iv) Eurocopter Emergency Alert Service Bulletin No. 65.47,
Revision 0, dated May 7, 2008.

    Note 2 to paragraph (i)(2): Eurocopter Emergency Alert Service
Bulletin (ASB) Nos. 63.00.17, 63A011, 65.03, and 65.47, all Revision
0, and all dated May 7, 2008 are co-published as one document along
with Eurocopter Emergency ASB No. 63.00.12, Revision 0, dated May 7,
2008, which is not incorporated by reference in this AD.

    (3) For Eurocopter service information identified in this AD,
contact American Eurocopter Corporation, 2701 Forum Drive, Grand
Prairie, Texas 75053-4005, telephone<PHONE_NUMBER>, fax (972) 641-
3710, or at http://www.eurocopter.com.

    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663,
Fort Worth, Texas 76137. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on December 20, 2012.
Kim Smith,
Directorate Manager, Rotorcraft Directorate, Aircraft Certification
Service.
[FR Doc. 2012-31682 Filed 1-8-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 64 (Wednesday, April 3, 2019)]
[Notices]
[Page 13095]
[FR Doc No: 2019-06398]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2019-0228]

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Operations
Specifications, Part 129 Application

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew a previously approved
information collection. The FAA assesses the information collected and
issues operations specifications to foreign air carriers. These
operations specifications assure the foreign air carrier's ability to
navigate and communicate safely within the U.S. National Airspace
System.

DATES: Written comments should be submitted by June 3, 2019.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field).
    By mail: Danuta Pronczuk, FAA, AFS-50, 600 Independence Avenue, 6th
Floor, Suite 6W1000, Washington, DC 20597.
    By fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Danuta Pronczuk by email at:
[email protected]; phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0749.
    Title: Operations Specifications, Part 129 Application.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: The final rule published in 2013, clarified and
standardized the rules for applications by foreign air carriers and
foreign persons for operations specifications issued under 14 CFR part
129 and established standards for amendment, suspension and termination
of those operations specifications. The final rule also applied to
foreign air carriers and foreign persons operating U.S.-registered
aircraft in common carriage solely outside the United States. This
action was necessary to update the process for issuing operations
specifications, and it established a regulatory basis for current
practices, such as amending, terminating, and suspending operations
specifications.
    Respondents: Approximately 25 new applicants annually.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 3 hours.
    Estimated Total Annual Burden: 75 hours.

    Issued in Washington, DC on March 26, 2019.
Robert C. Carty,
Deputy Executive Director, Flight Standards Service.
[FR Doc. 2019-06398 Filed 4-2-19; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 99 (Tuesday, May 25, 2021)]
[Notices]
[Page 28126]
[FR Doc No: 2021-11000]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4482-DR; Docket ID FEMA-2021-0001]

California; Amendment No. 4 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for State of California (FEMA-4482-DR), dated March 22, 2020, and
related determinations.

DATES: This change occurred on April 26, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Robert J.
Fenton, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of Tammy L. Littrell as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-11000 Filed 5-24-21; 8:45 am]
BILLING CODE 9111-23-P