[Federal Register Volume 84, Number 94 (Wednesday, May 15, 2019)]
[Notices]
[Pages 21772-21773]
[FR Doc No: 2019-10070]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0426; FRL-9993-61]

TSCA Inventory Notification (Active-Inactive) Requirements;
Availability of a Signed Action Identifying Chemical Substances for
Inactive Designation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: EPA is announcing the availability of a signed action
identifying chemical substances for inactive designation according to
the Toxic Substances Control Act (TSCA) Inventory Notification (Active-
Inactive) Requirements rule. The signed action is a companion to the
first version of the TSCA Chemical Substance Inventory with all
listings designated as active or identified as inactive, which was
posted on the EPA TSCA inventory web page on February 19, 2019. The
signed action, dated May 6, 2019, initiates a 90-day period after which
substances identified as inactive will be designated as inactive.

DATES: Inactive designations for chemical substances on the TSCA
Chemical Substance Inventory are effective on Monday, August 5, 2019.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Tracy Williamson, Chemistry, Economics, and Sustainable Strategies
Division (Mailcode 7406M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422

South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-
1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be affected by this action if you currently domestically
manufacture, import, or process for nonexempt commercial purpose a
chemical substance identified as inactive on the TSCA Chemical
Substance Inventory (``TSCA Inventory''). You may also be affected by
this action if you intend in the future to domestically manufacture,
import, or process a chemical substance identified as inactive on the
TSCA Inventory.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPPT-2016-0426, is available online at http://www.regulations.gov or in person at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket that is available at http://www.epa.gov/dockets. You
also will find related information at http://www.epa.gov/tsca-inventory.

II. Authority

    As amended in June 2016, TSCA section 8(b), 15 U.S.C. 2607(b),
requires that EPA designate chemical substances on the TSCA Inventory
as active or inactive in U.S. commerce. TSCA section 8(b)(4) directs
EPA to promulgate a rule that requires manufacturers, and may require
processors, to notify EPA of each chemical substance on the TSCA
Inventory that they manufactured or processed (as applicable) for a
nonexempt commercial purpose during the 10-year period ending on the
day before June 22, 2016. Following this retrospective reporting, EPA
must designate chemical substances for which notices are received to be
active substances on the TSCA Inventory and must designate chemical
substances for which no notices are received to be inactive substances
on the TSCA Inventory.
    TSCA section 8(b) establishes a forward-looking reporting
requirement that goes into effect upon EPA's designation of a chemical
substance as inactive. Specifically, anyone intending to manufacture or
process for a nonexempt commercial purpose a chemical substance that is
designated as an inactive substance must notify EPA before the inactive
substance is manufactured or processed. On receiving this forward-
looking notification, EPA must designate the substance as active.
    EPA implemented the TSCA section 8(b) requirements through the TSCA
Inventory Notification (Active-Inactive) Requirements rule (82 FR
37520, Aug. 11, 2017) (FRL-9964-22), which established retrospective
and forward-looking reporting procedures in 40 CFR part 710, subpart B.
Retrospective commercial activity reporting closed on October 5, 2018.
EPA subsequently compiled the first version of the TSCA Inventory with
all substances either designated as active in commerce or identified as
inactive in commerce.
    EPA regulations at 40 CFR 710.23 provide that EPA's designation of
a chemical substance as inactive becomes effective 90 days after EPA
identifies the chemical substance for such designation. EPA explained
in the preamble to the final rule that EPA will identify chemical
substances for inactive designation in a signed action accompanying the
first version of the Inventory with all finalized active-inactive
listings. See 82 FR at 37525. Subject to certain exceptions, once a
chemical substance is designated as inactive, any person who intends to
manufacture (including import) or process that substance must submit a
Notice of Activity Form B to EPA prior to such manufacturing or
processing. See 40 CFR 710.25(c) and 710.30(b). EPA regulations also
allow a Form B to be submitted during the 90-day period between EPA's
identification of a chemical substance for inactive designation and the
effective date for such designation. See 40 CFR 710.30(b)(2).

III. Notice of Inactive Designations

    EPA is announcing the availability of an EPA memorandum signed on
May 6, 2019. This signed action is a companion to the first version of
the TSCA Inventory with all listings designated as active or identified
as inactive, which was posted on the EPA TSCA Inventory web page on
February 19, 2019. The TSCA Inventory can be accessed at https://www.epa.gov/tsca-inventory. The signed action is available in docket ID
number EPA-HQ-OPPT-2016-0426 at http://www.regulations.gov.
    The signed action initiates the 90-day period after which
substances identified as inactive will be designated as inactive.
Because the action was signed on May 6, 2019, inactive designations
will become effective on Monday, August 5, 2019. Accordingly, the
obligation described in 40 CFR 710.25(c) and 710.30(b) to submit a
Notice of Activity Form B before manufacturing or processing an
inactive substance will arise beginning on Monday August 5, 2019.

    Authority:  15 U.S.C. 2607(b).

    Dated: May 9, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2019-10070 Filed 5-14-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 53 (Wednesday, March 19, 2014)]
[Notices]
[Pages 15383-15384]
[FR Doc No: 2014-05964]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2011-0126]

Reports, Forms, and Recordkeeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below has been forwarded to the
Office of Management and Budget (OMB) for review and comment. The ICR
describes the nature of the information collections and their expected
burden. The Federal Register Notice with a 60-day comment period was
published on December 19, 2012 (77 FR 75255).

DATES: Comments must be submitted on or before April 18, 2014.

FOR FURTHER INFORMATION CONTACT: Kil-Jae Hong, NHTSA, 1200 New Jersey
Avenue SE., W52-232, NPO-520, Washington, DC 20590. Ms. Hong's
telephone number is<PHONE_NUMBER> and email address is<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

National Highway Traffic Safety Administration

    Title: 49 CFR 575--Consumer Information Regulations (sections 103
and 105) Qualitative Research.
    OMB Number: Not Assigned.
    Type of Request: Request for public comment on collection of
information request.
    Abstract: The Energy Independence and Security Act of 2007, enacted
in December 2007, included a requirement that the National Highway
Traffic Safety Administration (NHTSA) develop a consumer information
and education campaign to improve consumer understanding of automobile
performance with regard to fuel economy, Greenhouse Gas emissions and
other pollutant emissions; of automobile use of alternative fuels; and
of thermal management technologies used on automobiles to save fuel. A
critical step in developing the consumer education program is to
conduct proper market research to understand consumers' knowledge
surrounding these issues, evaluate potential consumer-facing messages
in terms of clarity and understand the communications channels through
which these messages should be presented. The research will allow NHTSA
to refine messaging to enhance comprehension and usefulness and will
guide the development of an effective communications plan and education
program. NHTSA proposes a multi-phased research project to gather the
data and apply analyses and results from the project to develop the
consumer information program and education campaign materials.
    Affected Public: Passenger vehicle consumers.
    Estimated Total Annual Burden: 108 hours.

ADDRESSES: Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725 17th
Street NW., Washington, DC 20503, Attention NHTSA Desk Officer.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology. A Comment to OMB is most effective if OMB
receives it within 30 days of publication.

    Issued in Washington, DC, on March 13, 2014.
John Donaldson,
Senior Associate Administrator (Acting), Policy and Operations.
[FR Doc. 2014-05964 Filed 3-18-14; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Pages 41274-41276]
[FR Doc No: 2017-18380]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-1283; FDA-2016-E-1291]

Determination of Regulatory Review Period for Purposes of Patent
Extension; KENGREAL

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for KENGREAL and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by October
30, 2017. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by February 26, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

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 October 30, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 30, 2017. 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 Nos.
FDA-2016-E-1283 and FDA-2016-E-1291 for ''Determination of Regulatory
Review Period for Purposes of Patent Extension; KENGREAL.'' 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 Office 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 Office. 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 Office, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product KENGREAL
(cangrelor tetrasodium). KENGREAL is indicated as an adjunct to
percutaneous coronary intervention for reducing the risk of
periprocedural myocardial infarction, repeat coronary
revascularization, and stent thrombosis in patients who have not been
treated with a P2Y12 platelet inhibitor and are not being
given a glycoprotein IIb/IIIa inhibitor. Subsequent to this approval,
the USPTO received patent term restoration applications for KENGREAL
(U.S. Patent Nos. 6,114,313 and 6,130,208) from AstraZeneca UK Limited,
and the USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated July 12,
2016, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of KENGREAL
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
KENGREAL is 6,122 days. Of this time, 5,338 days occurred during the
testing phase of the regulatory review period, while 784 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: September 19, 1998. The applicant claims August 20, 1998, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was September 19, 1998, which

was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: April 30,
2013. FDA has verified the applicant's claim that the new drug
application (NDA) for KENGREAL (NDA 204958) was initially submitted on
April 30, 2013.
    3. The date the application was approved: June 22, 2015. FDA has
verified the applicant's claim that NDA 204958 was approved on June 22,
2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 5 years of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in 21 CFR 60.30, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period. To meet its burden,
the petition must comply with all the requirements of 21 CFR 60.30,
including but not limited to: Must be timely (see DATES), must be filed
in accordance with 21 CFR 10.20, must contain sufficient facts to merit
an FDA investigation, and must certify that a true and complete copy of
the petition has been served upon the patent applicant. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: August 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18380 Filed 8-29-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 75, Number 44 (Monday, March 8, 2010)]
[Notices]
[Pages 10541-10542]
[FR Doc No: 2010-4734]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61606; File No. SR-NASDAQ-2010-026]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Eliminate Erroneous Citations From Rule 9557

March 1, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 24, 2010, The NASDAQ Stock Market LLC (``Nasdaq'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by Nasdaq. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq is proposing to eliminate erroneous citations found under
Rule 9557. The text of the proposed rule change is below. Proposed new
language is in italics and proposed deletions are in brackets.
    9557. Procedures for Regulating Activities Under Rules 4110A[,] and
4120A [and 4130A] Regarding a Member Experiencing Financial or
Operational Difficulties

    (a) Notice of Requirements and/or Restrictions; Nasdaq Action
    Nasdaq Regulation staff may issue a notice directing a member to
comply with the provisions of Rule 4110A[,]  or 4120A [or 4130A]or
restrict its business activities, either by limiting or ceasing to
conduct those activities consistent with Rule 4110A[,] or 4120A [or
4130A], if Nasdaq Regulation staff has reason to believe that a
condition specified in Rule 4110A[,] or 4120A [or 4130A] exists. A
notice served under this Rule shall constitute Nasdaq action.
    (b)-(f) No change.
    (g) Additional Requirements and/or Restrictions or the Removal or
Reduction of Requirements and/or Restrictions; Letter of Withdrawal of
the Notice
    (1) Additional Requirements and/or Restrictions
    If a member continues to experience financial or operational
difficulty specified in Rule 4110A or 4120A [or 4130A], notwithstanding
an effective notice, Nasdaq Regulation staff may impose additional
requirements and/or restrictions by serving an additional notice under
paragraph (b) of this Rule. The additional notice shall inform the
member that it may apply for relief from the additional requirements
and/or restrictions by filing a written request for a letter of
withdrawal of the notice and/or a written request for a hearing before
the Office of Hearing Officers under Rule 9559. The procedures
delineated in this Rule shall be applicable to such additional notice.
    (2) No change.
    (A)-(B) No change.
    (h) No change.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, Nasdaq included statements
concerning the purpose of, and basis for, the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below, and is set forth in Sections A, B, and C below.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Nasdaq is proposing to eliminate erroneous citations found under
Rule 9557. Many of Nasdaq's rules are based on rules of Financial
Industry Regulatory Authority (``FINRA''). Nasdaq endeavors to keep
these common rules consistent with the analogous rules of FINRA, to the
extent possible. FINRA recently adopted new consolidated financial
responsibility rules found under a new FINRA Rule 4000 series.\3\ On
January 20, 2010, Nasdaq filed a proposed rule change to make
conforming changes to its rules, which included the adoption of a new
Rule 4000A series \4\ and certain amendments to Rules 9557 and 9559.\5\
The proposed changes were immediately effective, and became operative
on February 19, 2010. In adopting the new consolidated rules, FINRA
eliminated Rule 3131 and in its place adopted a new Rule 4130 that
concerns the regulation of activities of Section 15C members
experiencing financial and/or operational difficulties and made
conforming changes to citations found under FINRA Rule 9557. Section
15C of the Exchange Act \6\ applies to government securities brokers
and dealers, which does not apply to Nasdaq's membership as no such
class of membership exists under Nasdaq rules. As a consequence, Nasdaq
did not adopt an analogous Rule 4130A. In revising citations in Rule
9557, however, Nasdaq inadvertently included erroneous references to
Rule 4130A. Accordingly, Nasdaq is proposing to eliminate the erroneous
references to Rule 4130A found in Rule 9557.
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    \3\ Securities Exchange Act Release No. 60933 (November 4,
2009), 74 FR 58334 (November 12, 2009) (SR-FINRA-2008-067).
    \4\ Nasdaq currently has rules under its 4000 series, so to
mirror the changes made by FINRA as closely as possible, Nasdaq
created a new Rule 4000A series.
    \5\ See supra, note 3.
    \6\ 15 U.S.C. 78o-5.
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2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\7\ in general and with Section
6(b)(5) of the Act,\8\ in particular in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. The proposed rule change
corrects certain erroneous citations inadvertently included in Rule
9557 when adopting the new Rule 4000A series.
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    \7\ 15 U.S.C. 78f.
    \8\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) \9\ of the Act and Rule 19b-
4(f)(6) thereunder.\10\
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act. Nasdaq has provided the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date of filing of the
proposed rule change.
    Nasdaq believes that the proposed rule change does not
significantly affect the protection of investors or the public interest
because it merely eliminates erroneous citations that, if left in the
rule text, would cause investor confusion.
    Nasdaq requests that the Commission waive the 30-day pre-operative
waiting period contained in Exchange Act Rule 19b-4(f)(6)(iii).\11\
Nasdaq requests this waiver so that these corrections can be both
immediately effective and operative, thus minimizing any confusion that
may be caused by the erroneous citations. The Commission notes the
proposed rule changes make technical non-substantive changes to Rule
9557. As noted above on January 20, 2010, Nasdaq filed a proposed rule
change to make conforming changes to its rules, which included adopting
a new Rule 4000A series\12\ and certain amendments to Rules 9557 and
9559.\13\ The proposed changes were immediately effective and became
operative on February 19, 2010. The Commission believes the earlier
operative date is consistent with the protection of investors and the
public interest because the proposed rule change permits Nasdaq to
implement the rule without further delay and in a timely manner for the
operative date of the financial responsibility rules.\14\
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    \11\ 17 CFR 240.19b-4(f)(6)(iii).
    \12\ Nasdaq currently has rules under its 4000 series, so to
mirror the changes made by FINRA as closely as possible, Nasdaq
created a new Rule 4000A series.
    \13\ See supra, note 3.
    \14\ For purposes only of waiving the 30-day operative delay of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, is consistent with the Act. Comments may be
submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2010-026 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-NASDAQ-2010-026.
This file number should be included on the subject line if e-mail is
used. To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of Nasdaq.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions.
    You should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-NASDAQ-2010-
026 and should be submitted on or before March 29, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-4734 Filed 3-5-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Proposed Rules]
[Pages 57168-57170]
[FR Doc No: 2020-20226]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0840; Project Identifier MCAI-2020-00907-T]
RIN 2120-AA64

Airworthiness Directives; Saab AB, Support and Services (Formerly
Known as Saab AB, Saab Aeronautics) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Saab AB, Support and Services Model 340A (SAAB/SF340A) and SAAB
340B airplanes; and Model SAAB 2000 airplanes. This proposed AD was
prompted by reports that certain nose landing gear (NLG) door
attachment bolts are susceptible to hydrogen embrittlement. This
proposed AD would require replacing certain NLG door attachment bolts
with serviceable bolts, as specified in a European Union Aviation
Safety Agency (EASA) AD, which will be incorporated by reference. The
FAA is proposing this AD to address the unsafe condition on these
products.

DATES: The FAA must receive comments on this proposed AD by October 30,
2020.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material incorporated by reference (IBR) in this AD, contact
the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49
221 8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu.
You may find this IBR material on the EASA website at https://ad.easa.europa.eu. You may view this IBR material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2020-0840.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0840; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, Large Aircraft Section, International Validation Branch, FAA,
2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-
3220; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to participate in this rulemaking by submitting
written comments, data, or views about this proposal. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time. Send your
comments to an address listed under the ADDRESSES section. Include
``Docket No. FAA-2020-0840; Project Identifier MCAI-2020-00907-T'' at
the beginning of your comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this proposed rulemaking. Before acting on this
proposal, the FAA will consider all comments received by the closing
date for comments. The FAA will consider comments filed after the
comment period has closed if it is possible to do so without incurring
expense or delay. The FAA may change this NPRM because of those
comments.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be

placed in the public docket of this NPRM. Submissions containing CBI
should be sent to the person identified in the FOR FURTHER INFORMATION
CONTACT section. Any commentary that the FAA receives which is not
specifically designated as CBI will be placed in the public docket for
this rulemaking.

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0149, dated July 7, 2020
(``EASA AD 2020-0149'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Saab AB, Support and Services Model 340A (SAAB/
SF340A) and SAAB 340B airplanes; and Model SAAB 2000 airplanes.
    This proposed AD was prompted by reports that certain NLG door
attachment bolts are susceptible to hydrogen embrittlement. The FAA is
proposing this AD to address NLG door attachment bolts that were
incorrectly manufactured and are susceptible to hydrogen embrittlement,
decreasing the mechanical characteristics. This condition could lead to
failure of the affected parts, which would impair the link between the
NLG and NLG door and could prevent the extension or retraction of the
NLG, and cause consequent damage to the airplane and possible loss of
control during landing. See the MCAI for additional background
information.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2020-0149 describes procedures for identifying and
replacing certain NLG door attachment bolts with serviceable bolts.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2020-0149 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2020-0149
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require compliance with EASA AD 2020-0149 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in the EASA AD does not mean that operators need comply only
with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in the EASA AD. Service information specified
in EASA AD 2020-0149 that is required for compliance with EASA AD 2020-
0149 will be available on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2020-0840 after the FAA
final rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 103 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                     Estimated Costs for Required Actions *
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
2 work-hours x $85 per hour = $170...........................             $ *           $170 *        $17,510 *
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data that would enable the FAA to provide parts cost estimates for the bolt
  replacement specified in this proposed AD.

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. The FAA does not control warranty
coverage for affected individuals. As a result, the FAA has included
all known costs in our cost estimate.

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.
    The FAA is 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

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

responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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):

Saab AB, Support and Services (Formerly Known as Saab AB, Saab
Aeronautics): Docket No. FAA-2020-0840; Project Identifier MCAI-
2020-00907-T.

(a) Comments Due Date

    The FAA must receive comments by October 30, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Saab AB, Support and Services (Formerly
Known as Saab AB, Saab Aeronautics) Model 340A (SAAB/SF340A) and
SAAB 340B airplanes; and Model SAAB 2000 airplanes, certificated in
any category.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
Gear.

(e) Reason

    This AD was prompted by reports that certain nose landing gear
(NLG) door attachment bolts are susceptible to hydrogen
embrittlement. The FAA is issuing this AD to address NLG door
attachment bolts that were incorrectly manufactured and are
susceptible to hydrogen embrittlement, decreasing the mechanical
characteristics. This condition could lead to failure of the
affected parts, which would impair the link between the NLG and NLG
door and could prevent the extension or retraction of the NLG, and
cause consequent damage to the airplane and possible loss of control
during landing.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2020-0149, dated July 7, 2020 (``EASA AD 2020-0149'').

(h) Exceptions to EASA AD 2020-0149

    (1) Where EASA AD 2020-0149 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2020-0149 does not apply
to this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the Large Aircraft Section, International Validation
Branch, send it to the attention of the person identified in
paragraph (j)(2) of this AD. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Saab AB,
Support and Services' EASA Design Organization Approval (DOA). If
approved by the DOA, the approval must include the DOA-authorized
signature.

(j) Related Information

    (1) For information about EASA AD 2020-0149, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu. You
may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2020-0840.
    (2) For more information about this AD, Shahram Daneshmandi,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
    Issued on September 9, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-20226 Filed 9-14-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 18, 2009 (Volume 74, Number 221)]
[Notices]
[Page 59579]
[DOCID:fr18no09-83]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0393]

Acrylamide in Food; Request for Comments and for Scientific Data
and Information; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments and scientific data and
information; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending to January
25, 2010, the comment period for the notice entitled ``Acrylamide in
Food; Request for Comments and for Scientific Data and Information,''
that appeared in the Federal Register of August 26, 2009 (74 FR 43134).
In the notice, FDA requested comments and scientific data and
information on acrylamide in food. The agency is taking this action in
response to a request for an extension to allow interested persons
additional time to submit comments.

DATES:  Submit written or electronic comments by January 25, 2010.

ADDRESSES:  Submit electronic comments and scientific data and
information to http://www.regulations.gov. Submit written comments and
scientific data and information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lauren Posnick Robin, Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 26, 2009 (74 FR 43134), FDA
published a notice with a 90-day comment period to request comments and
scientific data and information on acrylamide in food. Comments on
practices that manufacturers have used to reduce acrylamide in food and
the reductions they have been able to achieve in acrylamide levels will
assist in FDA's development of guidance for industry on reduction of
acrylamide levels in food products, should FDA decide to issue guidance
on this topic.
    The agency has received a request for a 60-day extension of the
comment period for this notice. FDA has considered the request and is
extending the comment period for the notice entitled ``Acrylamide in
Food; Request for Comments and for Scientific Data and Information,''
until January 25, 2010. The agency believes that this extension allows
adequate time for interested persons to submit comments without
significantly delaying action by the agency.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments on this document. Submit
a single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in brackets in the
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 10, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27692 Filed 11-17-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Rules and Regulations]
[Pages 12363-12366]
[FR Doc No: 2014-04548]

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

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0125; Directorate Identifier 2013-NM-119-AD;
Amendment 39-17778; AD 2014-05-05]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 777 airplanes. This AD requires, for certain
airplanes, replacing radio altimeter transceivers with upgraded units,
and, for all airplanes, replacing low range radio altimeter antennas
with new antennas. This AD was prompted by operator reports of erratic
low range radio altimeter (LRRA) operation while the airplane is
airborne. We are issuing this AD to prevent adverse system responses
and flight deck effects that could result in loss of controllability of
the airplane or landing short of the runway during landing.

DATES: This AD is effective March 20, 2014.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of March 20,
2014.
    We must receive comments on this AD by April 21, 2014.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, 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, WA 98124-2207; telephone<PHONE_NUMBER>,
extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
You may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0125; 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 (phone:
800-647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Walter Cameron, Aerospace Engineer,
Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We have received operator reports of erratic low range radio
altimeter (LRRA) operation while the airplane is airborne. The symptoms
of erratic LRRA can include the following:
     Large differences between captain's and first officer's
radio altitudes or a negative altitude in air.
     ``NO LAND 3'' or ``NO AUTOLAND'' Engine Indication and
Crew Alerting System (EICAS) message.
     Autopilot disconnect, inability to engage autopilot, or
flight directors bias-out-of view.
     Autothrottle disconnect, autothrottle retard, or inability
to engage autothrottle into SPD (Speed) mode.
     Unexpected configuration warnings after takeoff, during
approach, or during go-around
     Missing or inappropriate aural height callouts
     Unavailability of auto speedbrake via ``AUTO SPEEDBRAKE''
EICAS message.
     Nuisance or missing Ground Proximity Warning System (GPWS)
warnings.
     Electronic Engine Control (EEC) indicating ground mode and
engine going to ground idle.
     Inability to engage Lateral Navigation (LNAV).
    Erratic LRRA operation events have been determined to possibly
result from the following causes:
     Antenna alteration at the antenna level can create micro
cracks on the electrical grounding connection, damage the coax cables
or the coax connector center pin contact. Any one of these damages to
the antenna assembly can affect the radio altimeter system
functionality.
     The currently installed radio altimeter transceivers on
some airplanes may not have adequate antenna monitoring capabilities
for detecting antenna deterioration caused by environmental conditions
or damage to the antenna during antenna alteration (which can result in
breaks in the coaxial cables or damage to the coax connector).
    These conditions, if not corrected, could result in adverse system
responses and flight deck effects that could result in loss of
controllability of the airplane or landing short of the runway during
landing. We are issuing this AD to correct the unsafe condition on
these products.

Relevant Service Information

    We reviewed Boeing Alert Service Bulletin 777-34A0191, Revision 1,
dated March 23, 2012, and Boeing Alert Service Bulletin 777-34A0192,
dated December 14, 2012. For information on the procedures and
compliance times, see this service information at http://www.regulations.gov by searching for Docket No. FAA-2014-0125.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

AD Requirements

    This AD requires accomplishing the actions specified in the service
information identified previously.

FAA's Justification and Determination of the Effective Date

    There are no products of this type currently registered in the
United States. However, this rule is necessary to ensure that the
described unsafe condition is addressed if any of these products are
placed on the U.S. Register in the future. Therefore, we find that
notice and opportunity for prior public comment are unnecessary and
that 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 was not preceded by notice and an opportunity for public
comment. 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 the docket number FAA-2014-0125 and
Directorate Identifier 2013-NM-119-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.

Costs of Compliance

    We estimate that this AD affects 0 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
               Action                         Labor cost            Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Transceiver Replacement............  2 work-hours x $85 per hour          $9,515          $9,685              $0
                                      = $170.
Antenna Replacement................  7 work-hours x $85 per hour           2,703           3,298               0
                                      = $595.
----------------------------------------------------------------------------------------------------------------

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

    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, 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.

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):

2014-05-05 The Boeing Company: Amendment 39-17778; Docket No. FAA-
2014-0125; Directorate Identifier 2013-NM-119-AD.

(a) Effective Date

    This AD is effective March 20, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 777-200, -200LR, -
300, -300ER, and 777F series airplanes, certificated in any
category, as identified in Boeing Alert Service Bulletin 777-
34A0192, dated December 14, 2012.

(d) Subject

    Joint Aircraft System Component (JASC) Code 34, Navigation.

(e) Unsafe Condition

    This AD was prompted by operator reports of erratic low range
radio altimeter (LRRA) operation while the airplane is airborne. We
are issuing this AD to prevent adverse system responses and flight
deck effects that could result in loss of controllability of the
airplane or landing short of the runway during landing.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

 (g) Replacement of Radio Altimeter Transceivers

    For airplanes identified in Boeing Alert Service Bulletin 777-
34A0191, Revision 1, dated March 23, 2012: Within 24 months after
the effective date of this AD, replace radio altimeter transceivers
with upgraded units, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 777-34A0191, Revision
1, dated March 23, 2012.

 (h) Replacement of Radio Altimeter Antennas

    For all airplanes: Within 36 months after the effective date of
this AD, replace low range radio altimeter transmit and receive
antennas with new antennas, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 777-34A0192, dated
December 14, 2012.

 (i) Credit for Previous Actions

    This paragraph provides credit for the actions specified in
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using Boeing Alert Service Bulletin 777-
34A0191, dated September 20, 2011, which is not incorporated by
reference in this AD.

 (j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the Seattle ACO, send it to
the attention of the person identified in paragraph (k)(1) of this
AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane.

(k) Related Information

    (1) For more information about this AD, contact Walter Cameron,
Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA,
Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton,
WA 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Service information identified in this AD that is not
incorporated by reference in this AD may be obtained at the address
specified in paragraph (l)(3) of this AD.

(l) 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) Boeing Alert Service Bulletin 777-34A0191, Revision 1, dated
March 23, 2012.
    (ii) Boeing Alert Service Bulletin 777-34A0192, dated December
14, 2012.
    (3) For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207;
telephone<PHONE_NUMBER>, extension 1; fax<PHONE_NUMBER>; Internet
https://www.myboeingfleet.com.
    (4) You may view this referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
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 Renton, Washington, on February 7, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-04548 Filed 3-4-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 92 (Friday, May 11, 2012)]
[Rules and Regulations]
[Pages 27624-27625]
[FR Doc No: 2012-11498]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2012-0369]

Drawbridge Operation Regulation; Cerritos Channel, Long Beach, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Commodore Schuyler F. Heim
Drawbridge across Cerritos Channel, mile 4.9, at Long Beach, CA. The
deviation is necessary to allow California Department of Transportation
to perform critical repair and replacement of electrical components for
drawspan operation. This deviation allows the drawbridge to remain in
the closed-to-navigation position.

DATES: This deviation is effective from 7 a.m. to 7 p.m. on June 10,
2012.

ADDRESSES: Documents mentioned in this preamble as being available in
the

docket are part of the docket USCG-2012-0369 and are available online
by going to http://www.regulations.gov, inserting USCG-2012-0369 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast
Guard District; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
If you have questions on viewing the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The California Department of Transportation
requested a temporary change to the operation of the Commodore Schuyler
F. Heim Drawbridge, mile 4.9, over Cerritos Channel, at Long Beach, CA.
The drawbridge navigation span provides a vertical clearance of 37 feet
above Mean High Water in the closed-to-navigation position and 163 feet
in the full open to navigation position. Pursuant to Sec.  117.147, the
draw opens on signal; except that, from 6:30 a.m. to 8 a.m. and 3:30
p.m. to 6 p.m., Monday through Friday except Federal holidays, the draw
need not be opened for the passage of vessels. Navigation on the
waterway is commercial, recreational, search and rescue, and law
enforcement.
    The drawspan will be secured in the closed-to-navigation position
from 7 a.m. through 7 p.m. on June 10, 2012 to perform critical repair
and replacement of electrical components for drawspan operation. The
alternative path around Terminal Island will be available for routine
and emergency navigation. This temporary deviation has been coordinated
with commercial and recreational waterway users. No objections to the
proposed temporary deviation were raised.
    Vessels that can transit the bridge, while in the closed-to-
navigation position, may continue to do so at any time.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: April 26, 2012.
D.H. Sulouff,
District Bridge Chief, Eleventh Coast Guard District.
[FR Doc. 2012-11498 Filed 5-10-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 109 (Tuesday, June 7, 2011)]
[Rules and Regulations]
[Pages 32863-32864]
[FR Doc No: 2011-13950]

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

Food and Drug Administration

21 CFR Parts 312 and 320

[Docket No. FDA-2010-D-0482]

Guidance for Industry and Investigators on Enforcement of Safety
Reporting Requirements for Investigational New Drug Applications and
Bioavailability/Bioequivalence Studies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of guidance.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry and investigators entitled
``Enforcement of Safety Reporting Requirements for INDs and BA/BE
Studies.'' This guidance is intended to inform sponsors and
investigators of FDA's intent to exercise enforcement discretion
regarding the reporting requirements in the final rule,
``Investigational New Drug Safety Reporting Requirements for Human Drug
and Biological Products and Safety Reporting Requirements for
Bioavailability and Bioequivalence Studies in Humans'' (75 FR 59935,
September 29, 2010), until September 28, 2011. This action is being
taken in response to requests from sponsors to extend the March 28,
2011, effective date of the final rule. FDA expects all sponsors and
investigators to be in compliance with the new regulations no later
than September 28, 2011.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-

305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Stephanie Shapley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6323, Silver Spring, MD 20993-0002, 301-
796-4836; or Laura Rich, Center for Biologics Evaluation and Research
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite
200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and
investigators entitled ``Enforcement of Safety Reporting Requirements
for INDs and BA/BE Studies.'' This guidance is being issued consistent
with FDA's good guidance practices (GGPs) regulation (Sec.  10.115 (21
CFR 10.115)). The guidance provides that the Agency intends to grant a
6-month period of enforcement discretion relating to the new reporting
requirements (described in this document) that became effective on
March 28, 2011. Accordingly, this guidance is being implemented without
prior public comment because the Agency has determined that prior
public participation is not feasible or appropriate (Sec.
10.115(g)(2)). The Agency made this determination because the guidance
deals with a short-term and highly time-sensitive issue. Although this
guidance document is immediately in effect, it remains subject to
comment in accordance with the Agency's GGPs regulation.
    On September 29, 2010, FDA published a final rule ``Investigational
New Drug Safety Reporting Requirements for Human Drug and Biological
Products and Safety Reporting Requirements for Bioavailability and
Bioequivalence Studies in Humans'' (75 FR 59935) and issued related
draft guidance ``Safety Reporting Requirements for INDs and BA/BE
Studies'' (75 FR 60129, Docket No. FDA-2010-D-0482). The final rule
amended the investigational new drug safety reporting requirements
under part 312 (21 CFR part 312) and added safety reporting
requirements for persons conducting bioavailability and bioequivalence
studies under part 320 (21 CFR part 320). The effective date for the
final rule was March 28, 2011. In comments to the docket, and in other
communications to the Agency placed in the docket, stakeholders have
requested an extension to the effective date of the final rule because
of the need for significant internal process changes in order to meet
the new requirements. Specifically, the comments indicated that
sponsors needed additional time to implement changes to their internal
procedures to comply with the new reporting requirements. The Agency
acknowledges these concerns and intends to exercise enforcement
discretion regarding the reporting requirements in the final rule until
September 28, 2011. During this period of time, FDA does not intend to
take enforcement action if sponsors and investigators report in
compliance with the reporting requirements under Sec. Sec.  312.32,
312.64, and 320.31 that were in effect prior to March 28, 2011.
    The guidance represents the Agency's current thinking on
enforcement of safety reporting requirements for investigational new
drug applications and bioavailability/bioequivalence studies. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov. Always access an FDA guidance document by using
FDA's Web site listed previously to find the most current version of
the guidance.

    Dated: June 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13950 Filed 6-6-11; 8:45 am]
BILLING CODE 4160-01-P