[Federal Register Volume 85, Number 72 (Tuesday, April 14, 2020)]
[Notices]
[Pages 20743-20745]
[FR Doc No: 2020-07789]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88608]

Order Granting Conditional Exemptive Relief, Pursuant to Section
36 of the Securities Exchange Act of 1934 (``Exchange Act'') and Rule
608(e) of Regulation NMS Under the Exchange Act to Rule 608(e) of
Regulation NMS Under the Exchange Act, Relating to Granularity of
Timestamps Specified in Section 6.8(b) and Appendix D, Section 3 of the
National Market System Plan Governing the Consolidated Audit Trail

April 8, 2020.

I. Introduction

    By letter dated February 3, 2020, BOX Exchange LLC, Cboe BYX
Exchange, Inc., Cboe BZX Exchange, Inc., Cboe EDGA Exchange, Inc., Cboe
EDGX Exchange, Inc., Cboe C2 Exchange, Inc., Cboe Exchange, Inc.,
Financial Industry Regulatory Authority, Inc. (``FINRA''), Investors
Exchange LLC, Miami International Securities Exchange LLC, MIAX
Emerald, LLC, MIAX PEARL, LLC, NASDAQ BX, LLC, Nasdaq GEMX, LLC, Nasdaq
ISE, LLC, Nasdaq MRX, LLC, NASDAQ PHLX LLC, The NASDAQ Stock Market
LLC, New York Stock Exchange LLC, NYSE American LLC, NYSE Arca, Inc.,
NYSE Chicago, Inc., NYSE National, Inc., and Long Term Stock Exchange,
Inc. (collectively, the ``Participants'') to the National Market System
Plan Governing the Consolidated Audit Trail (``CAT NMS Plan''),\1\
requested that the Securities and Exchange Commission (``Commission''
or ``SEC'') grant limited exemptive relief to the Participants,
pursuant to its authority under Section 36 of the Securities Exchange
Act of 1934 (``Exchange Act'') \2\ and Rule 608(e) of Regulation NMS
under the Exchange Act, from the timestamp granularity requirements of
Section 6.8(b) and Section 3 of Appendix D of the CAT NMS Plan.\3\
---------------------------------------------------------------------------

    \1\ The CAT NMS Plan was approved by the Commission, as
modified, on November 15, 2016. See Securities Exchange Act Release
No79318 (November 15, 2016), 81 FR 84696 (November 23, 2016) (``CAT
NMS Plan Approval Order'').
    \2\ 15 U.S.C. 78mm(a)(1).
    \3\ See letter from the Participants to Vanessa Countryman,
Secretary, Commission, dated February 3, 2020 (the ``February 3,
2020 Exemption Request''). Unless otherwise noted, capitalized terms
are used as defined in the CAT NMS Plan.
---------------------------------------------------------------------------

    Section 36 of the Exchange Act grants the Commission the authority,
with certain limitations, to ``conditionally or unconditionally exempt
any person, security, or transaction . . . from any provision or
provisions of [the Exchange Act] or of any rule or regulation
thereunder, to the extent that such exemption is necessary or
appropriate in the public interest, and is consistent with the
protection of investors.'' \4\ Under Rule 608(e) of Regulation NMS, the
Commission may ``exempt from [Rule 608], either unconditionally or on
specified terms and conditions, any self-regulatory organization,
member thereof, or specified security, if the Commission determines
that such exemption is consistent with the public interest, the
protection of investors, the maintenance of fair and orderly markets
and the removal of impediments to, and perfection of the mechanism of,
a national market system.'' \5\
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78mm(a)(1).
    \5\ 17 CFR 242.608(e).
---------------------------------------------------------------------------

    For the reasons set forth below, this Order grants the
Participants' request for an exemption from Section 6.8(b) and Appendix
D, Section 3 of the CAT NMS Plan as set forth in the February 3, 2020
Exemption Request, subject to certain conditions.\6\
---------------------------------------------------------------------------

    \6\ The February 3, 2020 Exemption Request also includes a
separate request for exemptive relief from Section 6.4(d)(ii)(C) of
the CAT NMS Plan. Specifically, in circumstances in which an
Industry Member uses an established trading relationship for an
individual Customer (rather than an account) on the order reported
to the CAT, the Participants request an exemption from the
requirement in Section 6.4(d)(ii)(C) of the CAT NMS Plan for each
Participant to require, through its Compliance Rules, its Industry
Members to record and report to the Central Repository the account
number, the date account opened and account type for the relevant
individual customer, subject to certain conditions. The Commission
is not addressing that request at this time.
---------------------------------------------------------------------------

II. Description

    The CAT NMS Plan sets forth certain requirements regarding the
granularity of timestamps accepted by the CAT system. Specifically,
Section 6.8(b) of the CAT NMS Plan states ``[e]ach Participant shall,
and through its Compliance Rule shall require its Industry Members to,
report information required by SEC Rule 613 and this Agreement to the
Central Repository in milliseconds,'' but that ``[t]o the extent that
any Participant's order handling or execution systems utilize
timestamps in increments finer than the minimum required in this
Agreement, such Participant shall utilize such finer increment when
reporting CAT Data to the Central Repository so that all Reportable
Events reported to the Central Repository can be adequately
sequenced.'' \7\ Section 6.8(b) further states that ``each Participant
shall, through its Compliance Rule: (i) Require that, to the extent
that its Industry Members utilize timestamps in increments finer than
the minimum required in this Agreement in their order handling or
execution systems, such Industry Members shall utilize such finer
increment when reporting CAT Data to the Central Repository.'' \8\ In
addition, Section 3 of Appendix D of the CAT NMS Plan states that the
Central Repository must be able to ``[a]ccept time stamps on order
events handled electronically to the finest level of granularity
captured by CAT Reporters.''
---------------------------------------------------------------------------

    \7\ Notwithstanding other requirements of Section 6.8(b), the
CAT NMS Plan provides that Participants and Industry Members are
permitted to record and report Manual Order Events and the time of
allocation on Allocation Reports in increments up to and including
one second. See CAT NMS Plan Section 6.8(b).
    \8\ The CAT NMS Plan defines ``Compliance Rule'' to mean, ``with
respect to a Participant, the rule(s) promulgated by such
Participant as contemplated by Section 3.11.'' See CAT NMS Plan
Section 1.1.
---------------------------------------------------------------------------

    Section 6.8(c) of the CAT NMS Plan imposes further requirements on
Participants regarding analysis of timestamp granularity. Specifically,
Section 6.8(c) of the CAT NMS Plan requires the Chief Compliance
Officer to, ``[i]n conjunction with Participants' and other appropriate
Industry Member advisory groups,'' ``annually evaluate and make a
recommendation to the Operating Committee as to whether industry
standards have evolved such that: . . . (ii) the required time stamp in
Section 6.8(b) should be in finer increments.''

III. Request for Relief

    In the February 3, 2020 Exemption Request, the Participants request
that the Commission exempt the Participants from the requirement in
Section 6.8(b) of the CAT NMS Plan that Participants reporting CAT Data
to the Central

Repository utilize timestamps finer than nanoseconds to the extent that
the Participant's order handling or execution systems utilize
timestamps in increments finer than nanoseconds. As a condition to this
exemption, if a Participant captures timestamps in increments more
granular than nanoseconds, such Participant would truncate the
timestamp after the nanosecond level for submission to CAT, not round
up or down in such circumstances. In addition, the Participants request
that the Commission exempt the Participants from the requirement in
Section 6.8(b) of the CAT NMS Plan for each Participant, through its
Compliance Rule, to require that, to the extent that its Industry
Members utilize timestamps in increments finer than nanoseconds in
their order handling or execution systems, such Industry Members
utilize such finer increment when reporting CAT Data to the Central
Repository. As a condition to this exemption, the Participants, through
their Compliance Rules, will require Industry Members that capture
timestamps in increments more granular than nanoseconds to truncate the
timestamps, after the nanosecond level for submission to CAT, not round
up or down in such circumstances.\9\ Lastly, the Participants request
that the Commission exempt the Participants from the requirement in
Section 3 of Appendix D of the CAT NMS Plan for the Central Repository
to be able to accept timestamps on order events handled electronically
to the finest level of granularity captured by CAT Reporters.
---------------------------------------------------------------------------

    \9\ Participants would require that electronic timestamps
submitted by Participants and Industry Members be truncated by
Participants and Industry Members if they capture timestamps in
increments more granular than nanoseconds, believing that rounding a
timestamp would suggest an event occurred later or earlier than it
actually occurred, while truncation treats all timestamps as if they
were provided with the same level of granularity.
---------------------------------------------------------------------------

    As a condition to this exemption, the Participants state that the
Central Repository will be required to accept timestamps on order
events handled electronically to a nanosecond granularity. In addition,
the Participants request that the above timestamp granularity exemptive
relief remain in effect for five years from the date that the
Commission grants the exemptive relief. After five years, the timestamp
granularity exemptive relief would no longer be in effect.
    The Participants state that they, in concert with the Plan
Processor, have determined that the cost of providing the ability to
utilize timestamps in the CAT in a finer granularity than nanoseconds
outweighs the benefits. The Participants further state that, based on
discussions with the Plan Processor, that Participants understand that
expanding the capture of timestamp granularity to picoseconds by the
Plan Processor would take at least six months at an estimated cost of
approximately $700,000, and that this effort would include technical
specification and database modifications, modifying query tools to
support querying and sequencing at a picosecond granularity. The
Participants also state that they understand that exchanges currently
utilize timestamps only to the nanosecond and do not utilize timestamps
to picoseconds or to finer increments.

IV. Discussion

    The Commission has carefully considered the information provided by
the Participants in support of the Participants' exemption request from
Section 6.8(b) and Section 3 of Appendix D of the CAT NMS Plan with
respect to timestamp granularity. Based on the information provided by
the Participants in the February 3, 2020 Exemption Request, the
Commission believes that the exemptive relief would provide cost
savings and reduce build time for the Plan Processor while not
negatively impacting the ability of regulators to use CAT. As noted
above, the Participants state that it would take at least six months
and approximately $700,000 to modify the Plan Processor to accept
picosecond timestamps. The Participants state that, as described above,
Section 6.8(c) of the CAT NMS Plan will require annual review of
timestamp granularity,\10\ and the Participants have requested that
such exemptive relief expire in five years.
---------------------------------------------------------------------------

    \10\ In the February 3, 2020 Exemption Request, the Participants
state that an analysis of the timestamp granularity would be
required as part of the annual evaluation required to be performed
by the Chief Compliance Officer pursuant to Section 6.8(c) of the
CAT NMS Plan. If the Operating Committee determines that this
analysis concludes that the benefit of the CAT Reporters reporting,
and the Central Repository providing the ability to accept,
timestamps in finer granularity than nanoseconds outweighs the
burdens, then the timestamp exemption could be terminated or be
revised to reflect more granular timestamps than nanoseconds in
accordance with the analysis. See February 3, 2020 Exemption
Request, supra note 2, at 4.
---------------------------------------------------------------------------

    The Commission has previously stated that regulators need
sufficiently granular timestamps to sequence events across orders and
within order lifecycles, and that a lack of uniform and granular
timestamps can limit the ability of regulators to sequence events
accurately and link data with information from other data sources.\11\
Many public data sources report time in seconds or milliseconds, and
some, including direct data feeds, report time in microseconds or
nanoseconds.\12\ The Participants state that the exchanges currently
utilize timestamps only to the nanosecond and do not utilize timestamps
to picoseconds or to finer increments.\13\ Nanoseconds are smaller than
milliseconds or microseconds and so the Participants' proposal would
result in the collection of information that is at least as granular as
existing data sources, and more granular than FINRA's Order Audit Trail
System which requires timestamps in milliseconds for firms that capture
time in milliseconds but does not require members to capture time in
milliseconds.\14\ The Participants also believe that CAT Reportable
Events can be adequately sequenced in the CAT without requiring
timestamps in a finer granularity than nanoseconds, and the
Participants believe that the requested relief would serve to maintain
and enhance the reliability and accuracy of the data reported to the
Central Repository.\15\
---------------------------------------------------------------------------

    \11\ See CAT NMS Plan Approval Order, supra note 1.
    \12\ Id. at 84813. For example, Options Price Reporting
Authority allows for timestamps in nanoseconds, while other
registered Securities Information Processors require timestamps in
microseconds for equity trades and quotes. Id. at 84813-14.
    \13\ See February 3, 2020 Exemption Request, supra note 2, at 3.
    \14\ See CAT NMS Plan Approval Order, supra note 1, at 84813-14.
    \15\ See February 3, 2020 Exemption Request, supra note 2, at 2
and 3.
---------------------------------------------------------------------------

    The proposed approach described in the February 3, 2020 Exemption
Request would require both Participants and Industry Members to
truncate timestamps in increments more granular than nanoseconds to
nanoseconds for submission to the CAT, and the Central Repository will
be required to accept timestamps on order events handled electronically
to a nanosecond granularity. Based on the foregoing, the Commission
believes that, pursuant to Section 36 of the Exchange Act, this
exemption is appropriate in the public interest and consistent with the
protection of investors, and that pursuant to Rule 608(e), this
exemption is consistent with the public interest, the protection of
investors, the maintenance of fair and orderly markets and the removal
of impediments to, and the perfection of a national market system to
exempt the SROs from Section 6.8(b) and Section 3 of Appendix D of the
CAT NMS Plan with respect to

timestamp granularity for a period of five years.
    Accordingly, it is hereby ordered, pursuant to Section 36(a)(1) of
the Exchange Act,\16\ and Rule 608(e) of the Exchange Act \17\ and with
respect to the proposed approaches specifically described above, that
the Participants are granted a five-year exemption from the timestamp
granularity requirement set forth in Section 6.8(b) and Section 3 of
Appendix D of the CAT NMS Plan of the CAT NMS Plan, subject to the
conditions described above.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78mm(a)(1).
    \17\ 17 CFR 242.608(e).

    By the Commission.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-07789 Filed 4-13-20; 8:45 am]
 BILLING CODE 8011-01-P


I. OW 2003 0006: Standards for the Use or Disposal of Sewage Sludge; Agency Response to the National Research Council Report on Biosolids Applied to Land and the Results of EPA's Review of Existing Sewage Sludge Regulations.

A. Federal Register Notice B. References Cited C. OMB Review Material D. Public Comments 1. Comments Received or Postmarked by July 8, 2003 2. Comments Received or Postmarked after July 8, 2003 OW 2003 0006 Sewage Sludge I A A. Federal Register Notice 1. Federal Register Notice. U. S. Environmental Protection Agency. Standards for the Use or Disposal of Sewage Sludge; Agency Response to the National Research Council Report on Biosolids Applied to Land and the Results of EPA's Review of Existing Sewage Sludge Regulations.. Vol. 68, No. 68, April 9, 2003. pp. 17379 17395. OW 2003 0006 Sewage Sludge I B B. References Cited 1. NRC, 1996. Use of Reclaimed Water and Sludge in Food Crop Production. The National Academies Press. Washington, DC. Available online at http:// www. nap. edu/ catalog/ 5175. html 2. NRC, 2002. Biosolids Applied to Land; Advancing Standards and Practices, National Research Council of the National Academies. The National Academies Press. Available online at http:// search. nap. edu/ books/ 0309084865/ html.

3. University of Arizona, National Science Foundation, Water Quality Center, within the Environmental Research Laboratory. Several studies ongoing. Ian L. Pepper, Director. Tuscon, Arizona. Ongoing research paper, no paper copy provided to the Docket.

4. USEPA, 1994. A Plain English Guide to the EPA Part 503 Biosolids Rule. 190 pages. Office of Water, Office of Wastewater Management. See W 99 18 SS PRO, I C. 7. Available online at: http:// www. epa. gov/ owm/ mtb/ biosolids/ 503pe/ index. htm.

5. USEPA, 1996. Technical Support Document for the Round Two Sewage Sludge Pollutants. EPA 822 R 96 003. Office of Water. Washington, DC. August, 1996. See W 99 18 SS PRO, I B. 7.

6. USEPA, 2002a. Compilation of National Research Council ( NRC) Recommendations on Biosolids and EPA Responses and Activities. 9 pages. Office of Water, Office of Science and Technology. Washington, DC.

7. USEPA, 2002b. Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency. EPA 260R 02 008. Office of Environmental Information. Washington, DC. October 2002. Available online at Http:// www. epa. gov/ oei/ qualityguidelines.

8. USEPA, 2002c. Screening History for the Part 503 Rounds One and Two Proposal. 4 pages. Office of Water, Office of Science and Technology. Washington, DC.

9. USEPA, 2002d. Literature Search of Publicly Available Information to Identify Information on Pollutants in Sewage Sludge Since 1990. 48 pages. Office of Water, Office of Science and Technology. Washington, DC.

10. USEPA, 2002e. Human Health Benchmarks for Potential Constituents in Biosolids. 11 pages. Office of Water, Office of Science and Technology. Washington, DC. OW 2003 0006 Sewage Sludge I B B. References Cited 11. USEPA, 2002f. List of Analytes from the 1989 National Sewage Sludge Survey Found in Less than 1% of the Samples. 7 pages. Office of Water, Office of Science and Technology. Washington, DC.

12. USEPA, 2002g. Summary of Analytes from the 1989 National Sewage Sludge Survey. 12 pages. Office of Water, Office of Science and Technology. Washington, DC.

13. USEPA, 2002h. Potential Analytes. 5 pages. Office of Water, Office of Science and Technology. Washington, DC.

14. USEPA, 2003a. In press. Contemporary Perspectives on Infectious Disease Agents In Sewage Sludge and Manure. Compost Science & Utilization/ The JG Press, Inc. Ongoing research, no paper copy available  not provided to the Docket.

15. USEPA, 2003b. Candidate Pollutants for Ongoing Sewage Sludge Evaluation. 15 pages. Office of Water, Office of Science and Technology. Washington, DC.

16. WERF, 2003. Dynamic Model to Assess Microbial Health Risks Associated with Beneficial Uses of Biosolids. Cooperative Agreement No. CR 825237. Alexandria, VA. Ongoing research, no paper copy available  not provided to the Docket. OW 2003 0006 Sewage Sludge I C C. OMB Review Material 1. Form for Compliance with E. O. 12866 Docket Requirements.


[Federal Register Volume 88, Number 214 (Tuesday, November 7, 2023)]
[Notices]
[Pages 76756-76760]
[FR Doc No: 2023-24547]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4742]

Phibro Animal Health Corp.; Proposal To Withdraw Approval of New
Animal Drug Applications for Carbadox in Medicated Swine Feed;
Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency), Center
for Veterinary Medicine (CVM), is proposing to withdraw approval of all
new animal drug applications (NADAs) providing for use of carbadox in
medicated swine feed, for which Phibro Animal Health Corp., Glenpointe
Centre East, Third Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck,
NJ 07666-6712, is the sponsor, and is announcing an opportunity for the
holder of the NADAs to request a hearing on this proposal. This action
is based on CVM's determination that there is no approved regulatory
method to detect the residue of carcinogenic concern in the edible
tissues of the treated swine.

DATES: The sponsor of the NADAs may submit a written request for a
hearing by December 7, 2023. Submit all data, information, and analyses
upon which a request for a hearing relies by December 7, 2023. Either
electronic or written comments on the notice must be submitted by
December 7, 2023.

ADDRESSES: The request for a hearing may be submitted by the sponsor of
the NADAs by either of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments to submit your request
for hearing. Your request for a hearing submitted electronically,
including any attachments to the request for hearing, to https://www.regulations.gov will be posted to the docket unchanged.

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper request for
a hearing): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

     Because your request for a hearing will be made public,
you are solely responsible for ensuring that your request does not
include any confidential information that you or a third party may not
wish to be publicly posted, such as confidential business information
(e.g., a manufacturing process). The request for a hearing must include
the Docket No. FDA-2023-N-4742 for ``Phibro Animal Health Corp.;
Proposal to Withdraw Approval of New Animal Drug Applications for
Carbadox in Medicated Swine Feed; Opportunity for a Hearing.'' The
request for a hearing will be placed in the docket and publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
    The sponsor of the NADAs may submit all data and analyses upon
which the request for a hearing relies in the same manner as the
request for a hearing except as follows:
     Confidential Submissions--To submit any data and analyses
with confidential information that you do not wish to be made publicly
available, submit your data and analyses only as a written/paper
submission. You should submit two copies total of all data and
analyses. 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
any decisions on this matter. 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
or available at the Dockets Management Staff between 9 a.m. and 4 p.m.,
Monday through Friday. Submit both copies to the Dockets Management
Staff. Any information marked as ``confidential'' will not be disclosed
except in accordance with 21 CFR 10.20 and other applicable disclosure
law.
    Comments Submitted by Other Interested Parties: For all comments
submitted by other interested parties, submit comments as follows.
Please note that late, untimely filed comments will not be considered.
The https://www.regulations.gov electronic filing system will accept
comments until 11:59 p.m. Eastern Time at the end of December 7, 2023.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are received 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-2023-N-4742 for ``Phibro Animal Health Corp.; Proposal to Withdraw
Approval of New Animal Drug Applications for Carbadox in Medicated
Swine Feed; Opportunity for a Hearing.'' 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Diane Heinz, Center for Veterinary
Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Approved NADAs for Use of Carbadox in Swine Feed

    Carbadox, a quinoxaline derivative, is a synthetic organic acid
antimicrobial. Currently, there are three approved NADAs for use of
carbadox in medicated swine feed, either by itself or in combination
with other approved new animal drugs. Phibro Animal Health Corp.,
Glenpointe Centre East, Third Floor, 300 Frank W. Burr Blvd., Suite 21,
Teaneck, NJ 07666-6712, is currently the sponsor of all three approved
NADAs.
    Carbadox is marketed as a Type A medicated article used to
manufacture complete Type C medicated feeds that are administered ad
libitum (available at all times) to swine. Carbadox is

indicated for the control of dysentery and bacterial enteritis, and for
growth promotion. A tolerance of 30 parts per billion (ppb) has been
established for residues of quinoxaline-2-carboxylic acid (QCA), the
marker residue, in liver of swine (21 CFR 556.100). The combination
products containing carbadox (carbadox and pyrantel, and carbadox and
oxytetracycline) are also approved for additional indications related
to the non-carbadox active ingredient.
    The following three NADAs are approved for the use of carbadox:
    NADA 041-061, originally approved in 1972 (37 FR 20683, October 3,
1972), provides for the use of MECADOX 10 (carbadox) Type A medicated
article to manufacture single-ingredient Type C medicated swine feeds
for the following conditions of use:
    Carbadox at 10 to 25 grams per ton (g/ton) of feed for increased
rate of weight gain and improved feed efficiency; and
    Carbadox at 50 g/ton of feed for control of swine dysentery
(vibrionic dysentery, bloody scours, or hemorrhagic dysentery); for
control of bacterial swine enteritis (salmonellosis or necrotic
enteritis caused by Salmonella choleraesuis); and for increased rate of
weight gain and improved feed efficiency.
    In January 1998, CVM approved a supplemental application to NADA
041-061, which included the approved method.
    In October 1998, CVM approved an additional supplemental NADA for
NADA 041-061, changing the withdrawal period for carbadox medicated
feeds from 70 days to 42 days.
    Currently, the withdrawal period for these uses of carbadox is 42
days (Sec.  558.115(d)(1)(ii) and (d)(2)(ii) (21 CFR 558.115(d)(1)(ii)
and (d)(2)(ii))).
    NADA 092-955, originally approved in 1975 (40 FR 45164, October 1,
1975), provides for the use of MECADOX 10 (carbadox) Type A medicated
article with BANMINTH (pyrantel tartrate) Type A medicated article to
manufacture two-way, combination drug Type C medicated swine feeds for
the following conditions of use:
    Carbadox at 50 g/ton of feed plus pyrantel tartrate at 96 g/ton of
feed for control of swine dysentery (vibrionic dysentery, bloody
scours, or hemorrhagic dysentery); for control of bacterial swine
enteritis (salmonellosis or necrotic enteritis caused by Salmonella
choleraesuis); as an aid in the prevention of migration and
establishment of large roundworm (Ascaris suum) infections; and as an
aid in the prevention of establishment of nodular worm
(Oesophagostomum) infections.
    The withdrawal period for the use of this drug combination is 70
days (Sec.  558.115(d)(3)(ii)).
    NADA 141-211, originally approved in 2004 (69 FR 51173, August 18,
2004), provides for the use of MECADOX 10 (carbadox) Type A medicated
article with TERRAMYCIN 50, TERRAMYCIN 100, or TERRAMYCIN 200
(oxytetracycline) Type A medicated articles to manufacture two-way,
combination drug Type C medicated swine feeds for the following
conditions of use:
    Carbadox at 10 to 25 g/ton of feed plus oxytetracycline at levels
in feed to deliver 10 mg oxytetracycline per pound of body weight for
treatment of bacterial enteritis caused by Escherichia coli and S.
choleraesuis susceptible to oxytetracycline; for treatment of bacterial
pneumonia caused by Pasteurella multocida susceptible to
oxytetracycline; and for increased rate of weight gain and improved
feed efficiency.
    The withdrawal period for the use of this animal drug combination
is 42 days (Sec.  558.115(d)(4); Sec.  558.450(e)(3)(iii)).

II. Basis for Withdrawal of Approval

    FDA is providing notice of an opportunity for a hearing (NOOH) on
CVM's proposal to withdraw approval of the NADAs providing for use of
carbadox in medicated swine feeds. New evidence demonstrates that the
Delaney Clause in section 512(d)(1)(I) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360b(d)(1)(I)), which requires that
no residue of a carcinogenic drug can be found in any edible portion of
the animal after slaughter, applies because the Diethylstilbestrol
(DES) Proviso exception is no longer met (see section III).
    Section 512(e)(1)(B) of the FD&C Act provides grounds for
withdrawal of approval of an NADA if new evidence not contained in such
application or not available until after such application was approved,
tests by new methods, or tests by methods not deemed reasonably
applicable when such application was approved, evaluated together with
the evidence available when the application was approved, shows that
the Delaney Clause, section 512(d)(1)(I) of the FD&C Act, applies to
the drug. Under the Delaney Clause, the Secretary shall not approve a
new animal drug application if ``such drug induces cancer when ingested
by man or animal or, after tests which are appropriate for the
evaluation of the safety of such drug, induces cancer in man or
animal'' (section 512 (d)(1)(I) of the FD&C Act). An exception to this
general rule, referred to as the ``DES Proviso,'' allows for the
approval of a carcinogenic new animal drug where FDA finds that, under
the approved conditions of use: (1) The drug will not adversely affect
the animals treated with the drug, and (2) no residues of the drug will
be found by an approved regulatory method in any edible tissues of or
in any foods yielded by the animal (section 512(d)(1)(I)(i) through
(ii) of the FD&C Act).
    Evidence available at the time of the approvals showed that
carbadox was carcinogenic. At the time of the January 1998 supplemental
approval, CVM concluded that carcinogenic residues, including
desoxycarbadox (DCBX), a known carcinogenic metabolite of carbadox,
depleted quickly (within 72 hours) while QCA residues depleted more
slowly (Ref. 1). However, new evidence not available at the time of the
approval, including studies conducted by the sponsor and submitted to
FDA from 2005 to 2016 and a study conducted by a third party and
summarized in a publication in 2022,\1\ demonstrates that the residue
of carcinogenic concern persists longer than previously known (Refs. 2
to 4). Because there is no established relationship between
concentrations of QCA measured by the approved method and
concentrations of the residue of carcinogenic concern, the approved
regulatory method cannot be used to measure the residue of carcinogenic
concern.
---------------------------------------------------------------------------

    \1\ ``Metabolism and Tissue Depletion of Carbadox in Swine,
Broilers, and Rats,'' Jie Zhang, Wei Qu, Zongchao Wang, and Yuanhu
Pan, ACS Agricultural Science & Technology 2022 2 (3), 477-485.
---------------------------------------------------------------------------

    Elsewhere in today's Federal Register, FDA is publishing a final
order (Ref. 5) revoking the approved regulatory method for carbadox
that measures QCA as a marker residue to detect the presence of any
residue of carcinogenic concern (Ref. 6). Currently, therefore, there
is no approved regulatory method for carbadox, and the second prong of
the DES Proviso is not met.

III. Background Information Regarding the Regulation of Carcinogenic
New Animal Drugs

    Under the Delaney Clause of the FD&C Act, the Secretary shall not
approve a carcinogenic new animal drug application unless the DES
Proviso applies (section 512(d)(1)(I)(i) through (ii) of the FD&C Act).
FDA has issued implementing regulations that set the requirements for
demonstrating that no residues of the drug will be found by an approved
regulatory method in any

edible tissues of or in any foods yielded from the animal (21 CFR part
500, subpart E). These regulations, referred to as the sensitivity of
the method regulations (SOM regulations), describe how FDA determines
whether the regulatory method proposed by a sponsor is sufficiently
sensitive to ensure that residues of carcinogenic concern in edible
tissues will not exceed concentrations that represent no significant
increase in the risk of cancer to humans.
    Pursuant to these regulations, FDA determines for each drug and
each drug metabolite (on the basis of the results of chronic bioassays
and other information) whether the drug or any of its metabolites are
carcinogenic (Sec.  500.84(a) (21 CFR 500.84(a))). For the drug and
each metabolite determined to be carcinogenic, FDA calculates, based
upon submitted assays, the concentration of the test compound in the
total diet of the test animal that corresponds to a maximum lifetime
risk of cancer in the test animal of 1 in 1 million (Sec. Sec.
500.82(b) (21 CFR 500.82(b)) and 500.84(c)(1)). FDA designates the
lowest value thus calculated as the So (Sec. Sec.  500.82(b)
and 500.84(c)(1)). The So corresponds to a concentration of
residue of carcinogenic concern in the total human diet that represents
no significant increase in the risk of cancer to people (Sec.
500.82(b)). Residue of carcinogenic concern includes all compounds in
the total residue of a demonstrated carcinogen excluding any compound
judged by FDA not to present a carcinogenic risk (Sec.  500.82(b)). The
total residues of carcinogenic concern (the drug and all of its
metabolites less metabolites shown to be noncarcinogenic) are regulated
based on the most potent carcinogenic residue (Sec.  500.84(c)(1)).
This approach ensures that use of the drug does not present a
significant increase in the risk of cancer when considering all
residues in edible tissues.
    Because the total diet is not derived only from food-producing
animals, the SOM regulations make adjustments for human food intake of
edible tissues and determine the concentration of residues of
carcinogenic concern in a specific edible tissue that corresponds to no
significant increase in the risk of cancer to the human consumer. FDA
assumes for purposes of these regulations that this value will
correspond to the concentration of residues in a specific edible tissue
that corresponds to a maximum lifetime risk of cancer in test animals
of 1 in 1 million. This value is termed the Sm (Sec. Sec.
500.82(b) and 500.84(c)(1)).
    Based on residue depletion data submitted by a sponsor, FDA selects
a target tissue (the edible tissue selected to monitor for residues in
the target animals) and a marker residue (a residue whose concentration
is in a known relationship to the concentration of the residues of
carcinogenic concern in the last tissue to deplete to the
Sm) and designates the concentration of the marker residue
that the regulatory method must be capable of detecting in the target
tissue (Sec.  500.86(a) through (c) (21 CFR 500.86(a) through (c))).
This value, termed the Rm, is the concentration of a marker
residue in the target tissue when the residue of carcinogenic concern
is equal to Sm (Sec.  500.82(b)). When the marker residue is
at or below the Rm, the residue of carcinogenic concern in
the human diet does not exceed So (Sec.  500.86(c)). This
regulation ensures that when the marker residue is no longer
detectable, the residue of carcinogenic concern does not exceed
Sm in any of the edible tissues (Sec. Sec.  500.82(b) and
500.86(c)).
    A sponsor must submit a regulatory method that is able to detect
the marker residue at or below the Rm (21 CFR 500.88(b) and
500.84(c)(2)) (``The LOD [Limit of Detection for the regulatory method]
must be less than or equal to Rm.'')). If a method is not
developed that can detect the marker residue at or below the
Rm, the requirements of the SOM regulations are not
satisfied, and FDA cannot approve the drug. The DES Proviso and FDA's
implementing regulations are satisfied where no marker residue is
detectable using the approved regulatory method under the proposed
conditions of use of the drug, including the proposed preslaughter
withdrawal period (Sec.  500.84(c)(3)).

IV. Notice of Opportunity for a Hearing

    CVM is proposing to withdraw approval of the three NADAs that
provide for use of carbadox in swine feed because new evidence
demonstrates that the drug does not meet the DES Proviso exception to
the Delaney Clause. There is currently no approved regulatory method
for carbadox.
    Therefore, notice is given to Phibro Animal Health Corp.,
Glenpointe Centre East, Third Floor, 300 Frank W. Burr Blvd., Suite 21,
Teaneck, NJ 07666-6712, and to all other interested persons, that the
Deputy Commissioner for Policy, Legislation, and International Affairs,
Office of Policy, Legislation, and International Affairs proposes to
issue an order under section 512(e) of the FD&C Act withdrawing
approval of all NADAs providing for use of carbadox in medicated swine
feed.
    In accordance with section 512 of the FD&C Act and 21 CFR part 514
and under the authority delegated to the Deputy Commissioner for
Policy, Legislation, and International Affairs, Office of Policy,
Legislation, and International Affairs by the Commissioner of Food and
Drugs, Phibro Animal Health Corp., the sponsor, is hereby given an
opportunity for a hearing to show why approvals of NADA 041-061, 092-
955, and 141-211 should not be withdrawn.
    If the sponsor, Phibro Animal Health Corp., wishes to request a
hearing, the sponsor must file the following: (1) a written notice of
participation and request for a hearing (see DATES and ADDRESSES) and
(2) the data, information, and analyses relied on to demonstrate that
there is a genuine and substantial issue of fact that requires a
hearing (see DATES and ADDRESSES). Any other interested person may also
submit comments on this notice. Procedures and requirements governing
this NOOH, a notice of appearance and request for a hearing, submission
of data, information, and analyses to justify a hearing, other
comments, and a grant or denial of a hearing, are contained in Sec.
514.200 (21 CFR 514.200) and 21 CFR part 12.
    The failure of a holder of an approval to timely file a request for
a hearing as required by Sec.  514.200 constitutes an election by the
holder not to avail itself of the opportunity for a hearing and
constitutes a waiver of any contentions concerning the legal status of
any such drug product, and the Director of CVM will summarily enter a
final order withdrawing the approvals. Any new animal drug product
marketed without an approved NADA is subject to regulatory action at
any time.
    A request for a hearing may not rest upon mere allegations or
denials but must set forth specific facts showing that there is a
genuine and substantial issue of fact that requires a hearing. If it
conclusively appears from the face of the data, information, and
factual analyses in the request for hearing that there is no genuine
and substantial issue of fact that precludes the withdrawal of approval
of the applications, or when a request for hearing is not made in the
required format or with the required analyses, the Commissioner of Food
and Drugs will enter summary judgment against the person who requests a
hearing, making findings and conclusions, and denying a hearing.
    If a hearing is requested and is justified by the sponsor's
response to this NOOH, the issues will be defined,

a presiding officer will be assigned, and a written notice of the time
and place at which the hearing will commence will be issued as soon as
practicable.
    This notice is issued under section 512 of the FD&C Act and under
the authority delegated to the Deputy Commissioner for Policy,
Legislation, and International Affairs, Office of Policy, Legislation,
and International Affairs.

V. Environmental Impact

    The Agency has determined under 21 CFR 25.33(g) that this action is
of a type that does not individually or cumulatively have a significant
impact on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. Although FDA
verified the website addresses in this document, please note that
websites are subject to change over time.

1. FDA, Freedom of Information Summary, NADA 041-061, MECADOX 10
(carbadox) Type A medicated article, supplemental approval January
30, 1998. Available at https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/308.
2. Evaluations of the Joint Food and Agriculture Organization of the
United Nations/World Health Organization Expert Committee on Food
Additives (JECFA). Carbadox. 2021. Available at: https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/2176.
3. Memorandum to File entitled ``CVM Response to Phibro Animal
Health Corporation's September 18, 2020 Comments on CVM's July 20,
2020 Proposed Order to Revoke the Regulatory Method for Carbadox''
(January 6, 2022).
4. Memorandum to File entitled ``CVM review of comments on the Zhang
article that Phibro references in the document submitted to the Part
15 Hearing docket under cover letter dated June 9, 2022, and
entitled, `Phibro Animal Health Corporation's Reply to the January
6, 2022 `CVM Response to Phibro Animal Health Corporation's
September 18, 2020 Comments on CVM's July 20, 2020 Proposed Order to
Revoke the Regulatory Method for Carbadox.' ' '' (October 30, 2023).
5. Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed;
Revocation of Approved Method (November 7, 2023).
6. ``Determination of Carbadox as Quinoxaline-2-carboxylic Residues
in Swine Liver and Muscle Tissues after Drug Withdrawal.'' Available
at https://www.fda.gov/media/136267/download.

    Dated: November 1, 2023.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2023-24547 Filed 11-6-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 249 (Friday, December 29, 2017)]
[Notices]
[Pages 61756-61757]
[FR Doc No: 2017-28104]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2016-0404; FRL-9972-71-OEI]

Submission to OMB for Review and Approval; Comment Request;
Information Collection Request for the National Study of Nutrient
Removal and Secondary Technologies: Publicly Owned Treatment Works
(POTW) Screener Questionnaire

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this
document announces that an Information Collection Request (ICR) for a
voluntary survey--Information Collection Request for the National Study
of Nutrient Removal and Secondary Technologies: Publicly Owned
Treatment Works (POTW) Screener Questionnaire, EPA ICR No. 2553.01, OMB
Control No. 2040 NEW--has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request for a new
collection. The ICR, which is abstracted below, describes the nature of
the information collection and its estimated burden and cost. An agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.

DATES: Additional comments may be submitted on or before January 29,
2018.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2016-0404 to (1) EPA online using www.regulations.gov (our preferred
method), by email to [email protected], or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460, and (2) OMB by mail to:
Office of Information and Regulatory Affairs, Office of Management and
Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street NW,
Washington, DC 20503.

    Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2016-
0404. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or email. For additional information about EPA's
public docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Dr. Paul Shriner, Engineering and
Analysis Division (4303T), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-566-
1076; email address: [email protected].

SUPPLEMENTARY INFORMATION: EPA has established a public docket for this
ICR under Docket ID No. EPA-HQ-OW-2016-0404, which is available at
https://www.regulations.gov, or for in-person viewing at the EPA Docket
Center, William J. Clinton West Building, Room 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<PHONE_NUMBER>, and the
telephone number for the Water Docket is<PHONE_NUMBER>.
    Use https://www.regulations.gov to submit or view public comments,
obtain a copy of the collection of information supporting statement,
including the screener survey, and to access those documents in the
public docket that are available electronically. Once in the system,
select ``search,'' then key in the docket ID number identified in this
document.
    Abstract: Nutrient pollution (e.g. nitrogen and phosphorus)
presents a growing threat to public health and local economies--
contributing to toxic harmful algal blooms, contamination of drinking
water sources, and costly impacts on recreation, tourism and fisheries.
The EPA is collaborating with states to make greater progress in
reducing nutrient loadings discharged into the nation's waters from all
sources. With this goal in mind, EPA's Office of Water is planning to
collect data to evaluate the nutrient removals and related technology
performance of publicly owned treatment works (POTWs) with conventional
secondary treatment. Currently, there are no comprehensive, nationwide
data on nutrient discharges and removals at POTWs. This study will
attempt to obtain nationwide data on nutrient removal to help set more
realistic and achievable nutrient reduction targets than may be the
case absent such data; help POTWs understand the range of opportunities
to optimize nutrient removals based on data from their peers, and;
encourage improved nutrient removal POTW performance with less expense.
This study will not only be useful to POTWs, but will also be useful to
all stakeholders involved in managing nutrients at the watershed level.
    The full study is designed with multiple phases over the course of
four to five years, allowing for interactions with stakeholders and
experts in each phase. The first phase of the study is a screener
questionnaire, which is the focus of this ICR. The goal of this first
phase is to identify and characterize the full population of POTWs in
the U.S. that discharge to a water of the U.S. This information will be
used to help establish a baseline of nutrient performance at the
national level for all POTWs. The second phase of the study will
collect data from a subset of POTWs designed for secondary treatment,
yet accomplishing significant nutrient removals. The study will
document the capability of different types of POTWs to reduce nutrient
discharges by implementing changes to operations and maintenance, but
without retrofitting to biological nutrient removal (BNR), making
chemical additions, or committing to extensive capital investments.
    EPA is limiting the information requested by this census to that
which is necessary to create a complete population of POTWs and to
identify basic information about that population. Questions include
those necessary to identify and stratify the universe of POTWs and,
within that population, the secondary treatment POTWs not designed
specifically to remove nitrogen and phosphorus.
    Respondents/affected entities: Approximately 17,000 POTWs that meet
the definition under 40 CFR 403.3(q), as well as up to 100 state and/or
small municipal association contacts and 47 state and/or territory
requests for POTW population data.
    Estimated total number of respondents: 13,600 POTWs, 40 POTWs for
site visits, 100 state or small municipal association contacts, and 47
states/territories for POTW population data.
    Frequency of response: One-time data collection.
    Estimated total respondent burden hours: 46,925.
    Estimated total respondent costs: $1,606,960. This estimate
reflects unit costs for labor.
    Change in the estimates: This is a new collection and thus
represents a one-time increase to the Agency's overall burden.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2017-28104 Filed 12-28-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46789-46790]
[FR Doc No: 2014-18890]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL14-86-000]

Attorney General of the Commonwealth of Massachusetts,
Connecticut Public Utilities Regulatory Authority, Massachusetts
Municipal Wholesale Electric Company, New Hampshire Electric
Cooperative, Inc., Massachusetts Department of Public Utilities, New
Hampshire Public Utilities Commission, George Jepsen, Attorney General
of the State of Connecticut, Connecticut Office of Consumer Counsel,
Maine Office of the Public Advocate, New Hampshire Office of the
Consumer Advocate, Rhode Island Division of Public Utilities and
Carriers, Vermont Department of Public Service, Associated Industries
of Massachusetts, The Energy Consortium, Power Options, Inc., Western
Massachusetts Industrial Group, Environment Northeast, National
Consumer Law Center, Greater Boston Real Estate Board, Industrial
Energy Consumer Group v. Bangor Hydro-Electric Company, Central Maine
Power Company, New England Power Company d/b/a National Grid New
Hampshire Transmission LLC d/b/a NextEra, Northeast Utilities Service
Company, on Behalf of Its Operating Company Affiliates: The Connecticut
Light and Power Company, Western Massachusetts Electric Company, Public
Service Company of New Hampshire, NSTAR Electric Company, The United
Illuminating Company, Unitil Energy Systems, Inc., Fitchburg Gas and
Electric Light Company, Vermont Transco, LLC; Notice of Complaint

    Take notice that on July 31, 2014, pursuant to Rule 206 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.206 and sections 206 and 306 of the Federal
Power Act, 16 U.S.C. 824(e) and 825(e), the Attorney General of the
Commonwealth of Massachusetts, Connecticut Public Utilities Regulatory
Authority, Massachusetts Municipal Wholesale Electric Company, New
Hampshire Electric Cooperative, Inc., Massachusetts Department of
Public Utilities, New Hampshire Public Utilities Commission, George
Jepsen, Attorney General of the State of Connecticut, Connecticut
Office of Consumer Counsel, Maine Office of the Public Advocate, New
Hampshire Office

of the Consumer Advocate, Rhode Island Division of Public Utilities and
Carriers, Vermont Department of Public Service, Associated Industries
of Massachusetts, The Energy Consortium, Power Options, Inc., Western
Massachusetts Industrial Group, Environment Northeast, National
Consumer Law Center, the Greater Boston Real Estate Board, and the
Industrial Energy Consumer Group (collectively, Complainants) filed a
formal complaint against Bangor Hydro-Electric Company, Central Maine
Power Company, New England Power Company d/b/a National Grid, New
Hampshire Transmission LLC d/b/a NextEra, NSTAR Electric Company,
Northeast Utilities Service Company, on behalf of its operating company
affiliates: The Connecticut Light and Power Company, Western
Massachusetts Electric Company, and Public Service Company of New
Hampshire, The United Illuminating Company, Unitil Energy Systems,
Inc., Fitchburg Gas and Electric Light Company, and Vermont Transco,
LLC (collectively, Respondents) alleging that, Respondents' return on
equity (ROE) currently reflected in ISO New England Inc.'s Open Access
Transmission Tariff (ISO-NE OATT) is unjust and unreasonable.
Complainants request the Commission issue an order to reduce the ROE
used in calculating formula rates for transmission service under the
ISO-NE OATT.
    The Complainants certifies that copies of the complaint were served
on the contacts for the Respondents and the ISO-NE as listed in the
Commission's list of Corporate Officials and on parties and the
regulatory agencies the Complainants reasonably expect to be affected
by this complaint.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on August 21, 2014.

    Dated: August 1, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-18890 Filed 8-8-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 121 (Thursday, June 23, 2011)]
[Notices]
[Pages 36909-36910]
[FR Doc No: 2011-15696]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC11-549B-000]

Commission Information Collection Activities (FERC-549B); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice of proposed information collection and request for
comments.

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

SUMMARY: In compliance with the requirements of section 3506(c)(2)(A)
of the Paperwork Reduction Act of 1995, 44 USC 3506(c)(2)(A) (2006),
(Pub. L. 104-13), the Federal Energy Regulatory Commission (Commission
or FERC) is soliciting public comment on the proposed information
collection described below.

DATES: Comments in consideration of the collection of information are
due August 22, 2011.

ADDRESSES: Commenters must send an original of their comments to:
Federal Energy Regulatory Commission, Secretary of the Commission, 888
First Street, NE., Washington, DC 20426. Comments may be filed either
on paper or on CD/DVD, and should refer to Docket No. IC11-549B-000.
Documents must be prepared in an acceptable filing format and in
compliance with Commission submission guidelines at http://www.ferc.gov/help/submission-guide.asp. eFiling and eSubscription are
not available for Docket No. IC11-549B-000, due to a system issue.
    All comments and FERC issuances may be viewed, printed or
downloaded remotely through FERC's eLibrary at http://www.ferc.gov/docs-filing/elibrary.asp, by searching on Docket No. IC11-549B. For
user assistance, contact FERC Online Support by e-mail at
<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER> (toll-free),
or<PHONE_NUMBER> for TTY.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by e-mail
at<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at
(202) 273-0873.

SUPPLEMENTARY INFORMATION: The information collected under the
requirements of FERC-549B, ``Gas Pipeline Rates: Capacity
Information,'' includes both the Index of Customers (IOC) report under
Commission regulations at 18 Code of Federal Regulations (CFR)
284.13(c) and three capacity reporting requirements. One of these is in
Commission regulations at 18 CFR 284.13(b) and requires reports on firm
and interruptible services. The second is at 18 CFR 284.13(d)(1) and
requires pipelines make information on capacity and flow information
available on their Internet Web sites. The third is at 18 CFR
284.13(d)(2) and requires an annual filing of peak day capacity.

Capacity Reports Under 284.13(b) and 284.13(d)(1)

    On April 4, 1992, in Order No. 636 (RM91-11-000), the Commission
established a capacity release mechanism under which shippers could
release firm transportation and storage capacity on either a short- or
long-term basis to other shippers wanting to obtain capacity. Pipelines
posted available firm and interruptible capacity information on their
electronic bulletin boards (EBBs) to inform potential shippers.
    On August 3, 1992, in Order No. 636-A (RM91-11-002), the Commission
determined through staff audits, that the efficiency of the capacity
release mechanism could be enhanced by standardizing the content and
format of capacity release information and the methods by which
shippers accessed this information, which pipelines posted to their
EBBs
    On March 29, 1995, through Order 577 (RM95-5-000), the Commission
amended Sec.  284.243(h) of its regulations to allow shippers the
ability to release capacity without having to comply with the
Commission's advance posting and bidding requirements.
    On February 9, 2000, in Order No. 637 (RM98-10-000), to create
greater substitution between different forms of capacity and to enhance
competition across the pipeline grid, the Commission revised its
capacity release regulations regarding scheduling, segmentation and
flexible point rights, penalties, and reporting requirements. This
resulted in more reliable capacity information availability and price
data that shippers needed to make informed decisions in a competitive
market as well as to improve shipper's and the Commission's ability to
monitor the market for potential abuses.

Peak Day Annual Capacity Report Under 284.13(d)(2)

    18 CFR 284.13(d)(2) requires an annual peak day capacity report of
all interstate pipelines, including natural gas storage only companies.
This report is generally a short report showing the peak day design
capacity or the actual peak day capacity achieved, with a short
explanation, if needed. The regulation states:

    An interstate pipeline must make an annual filing by March 1 of
each year showing the estimated peak day capacity of

the pipeline's system, and the estimated storage capacity and
maximum daily delivery capability of storage facilities under
reasonably representative operating assumptions and the respective
assignments of that capacity to the various firm services provided
by the pipeline.

    This annual report/filing is publicly available, while other more
specific interstate pipeline and storage capacity details are filed as
CEII, such as the Annual System Flow Diagram (FERC-567) which are not
publicly available.

Index of Customers Under 284.13(c)

    In Order 581, issued September 28, 1995 (Docket No. RM95-4-000),
the Commission established the IOC quarterly information requirement.
This Order required the reporting of five data elements in the IOC
filing: the customer name, the rate schedule under which service is
rendered, the contract effective date, the contract termination date,
and the maximum daily contract quantity, for either transportation or
storage service, as appropriate.
    In a notice issued separate from Order 581 in Docket No. RM95-4-
000, issued February 29, 1996, the Commission, through technical
conferences with industry, determined that the IOC data reported should
be in tab delimited format on diskette and in a form as proscribed in
Appendix A of the rulemaking. In a departure from past practice, a
three-digit code, instead of a six-digit code, was established to
identify the respondent.
    In Order 637, issued February 9, 2000 (Docket Nos. RM98-10-000 and
RM98-12-000), the Commission required the filing of: the receipt and
delivery points held under contract and the zones or segments in which
the capacity is held, the common transaction point codes, the contract
number, the shipper identification number, an indication whether the
contract includes negotiated rates, the names of any agents or asset
managers that control capacity in a pipeline rate zone, and any
affiliate relationship between the pipeline and the holder of capacity.
It was stated in the Order that the changes to the Commission's
reporting requirements would enhance the reliability of information
about capacity availability and price that shippers need to make
informed decisions in a competitive market as well as improve shippers'
and the Commission's ability to monitor marketplace behavior to detect,
and remedy anti-competitive behavior. Order 637 required a pipeline
post the information quarterly on its Internet websites instead of on
the outdated EBBs.
    Action: The Commission is requesting a three-year extension of the
FERC-549B reporting requirements, with no changes.
    Burden Statement: The estimated annual public reporting burden for
this collection is estimated as:

----------------------------------------------------------------------------------------------------------------
                                       Number of           Number of
      FERC-549B requirement           respondents        responses per      Average burden       Total annual
                                       annually           respondent      hours per response     burden hours
----------------------------------------------------------------------------------------------------------------
                                                 (1)                 (2)                 (3)     (1) x (2) x (3)
----------------------------------------------------------------------------------------------------------------
Capacity Reports under 284.13(b)                 129                   6                 145             112,230
 and 284.13(d)(1)...............
Peak Day Annual Capacity Report                  129                   1                  10               1,290
 under 284.13(d)(2).............
Index of Customers under                         129                   4                   3               1,548
 284.13(c)......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..................  ..................  ..................             115,068
----------------------------------------------------------------------------------------------------------------

     The total estimated annual cost burden to respondents is
$7,876,183 (115,068 hours/2,080 hours \1\ per year, times $142,372
\2\). The estimated annual burden per respondent is $61,056 (rounded).
---------------------------------------------------------------------------

    \1\ Estimated number of hours an employee works each year.
    \2\ Estimated average annual cost per employee.
---------------------------------------------------------------------------

    The reporting burden includes the total time, effort, or financial
resources expended to generate, maintain, retain, disclose, or provide
the information including: (1) Reviewing instructions; (2) developing,
acquiring, installing, and utilizing technology and systems for the
purposes of collecting, validating, verifying, processing, maintaining,
disclosing and providing information; (3) adjusting the existing ways
to comply with any previously applicable instructions and requirements;
(4) training personnel to respond to a collection of information; (5)
searching data sources; (6) completing and reviewing the collection of
information; and (7) transmitting or otherwise disclosing the
information.
    The estimate of cost for respondents is based upon salaries for
professional and clerical support, as well as direct and indirect
overhead costs. Direct costs include all costs directly attributable to
providing this information, such as administrative costs and the cost
for information technology. Indirect or overhead costs are costs
incurred by an organization in support of its mission. These costs
apply to activities which benefit the whole organization rather than
any one particular function or activity.
    Comments are invited on: (1) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information to be collected; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology e.g. permitting electronic submission of
responses.

    Dated: June 16, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-15696 Filed 6-22-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 178 (Monday, September 15, 2014)]
[Notices]
[Page 54976]
[FR Doc No: 2014-21863]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12796-004]

City of Wadsworth, Ohio; Notice of Teleconference

    a. Date and Time of Meeting: Tuesday, September 23, 2014 at 10:00
a.m. (Eastern Daylight Time).
    b. FERC Contact: Andy Bernick, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    c. Purpose of Meeting: To discuss the U.S. Fish and Wildlife
Service's responses to Commission staff's determinations of effect for
federally listed species described in the Draft Environmental
Assessment for Hydropower License, for the proposed R.C. Byrd
Hydroelectric Project, issued on July 8, 2014.
    d. Proposed Agenda:

1. Introduction
2. Bats
3. Freshwater Mussels
4. Summary

    e. All local, state, and federal agencies, Indian tribes, and other
interested parties are invited to participate by phone. Please call
Andy Bernick at<PHONE_NUMBER> by Tuesday, September 16, 2014, to RSVP
and to receive specific instructions on how to participate.

    Dated: September 3, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-21863 Filed 9-12-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: September 2, 2010 (Volume 75, Number 170)]
[Rules and Regulations]
[Page 53849-53851]
[DOCID:fr02se10-5]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0851; Directorate Identifier 2010-NM-171-AD;
Amendment 39-16424; AD 2010-18-11]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Model CL-600-2C10
(Regional Jet Series 700, 701, & 702); Model CL-600-2D15 (Regional Jet
Series 705); and Model CL-600-2D24 (Regional Jet Series 900) Airplanes

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

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    During maintenance at the vendor's facility, some HSTAs
[horizontal stabilizer trim actuators] were assembled with the
incorrect load bearing balls. The material of these discrepant balls
has lower wear characteristics and as such, has a shorter expected
life. If not corrected, this condition can result in the HSTA jam
leading to difficulties in controlling the aircraft.

* * * * *
The unsafe condition is possible loss of controllability of the
airplane. This AD requires actions that are intended to address the
unsafe condition described in the MCAI.

DATES: This AD becomes effective September 17, 2010.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of September 17,
2010.
    We must receive comments on this AD by October 18, 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 W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

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, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Christopher Alfano, Aerospace
Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New
York Aircraft Certification Office (ACO), 1600 Stewart Avenue, Suite
410, Westbury, New York 11590; telephone<PHONE_NUMBER>; fax (516) 794-
5531.

SUPPLEMENTARY INFORMATION:

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2010-20, dated July 19, 2010 (referred to after this as ``the MCAI''),
to correct an unsafe condition for the specified products. The MCAI
states:

    During maintenance at the vendor's facility, some HSTAs were
assembled with the incorrect load bearing balls. The material of
these discrepant balls has lower wear characteristics and as such,
has a shorter expected life. If not corrected, this condition can
result in the HSTA jam leading to difficulties in controlling the
aircraft.
    This directive mandates incorporation of the HSTA with the
correct load bearing balls.

The unsafe condition is possible loss of controllability of the
airplane. The corrective action requires inspecting to determine the
serial number of the HSTAs. You may obtain further information by
examining the MCAI in the AD docket.

Relevant Service Information

    Bombardier has issued Service Bulletin 670BA-27-057, dated June 14,
2010. The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This AD

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

Differences Between the AD and the MCAI or Service Information

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

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because some
HSTAs were assembled with load bearing balls that have lower wear
characteristics and a shorter life expectancy. If not corrected, this
condition can result in the HSTA jam leading to difficulties in
controlling the airplane. The unsafe condition is possible loss of
controllability of the airplane. Therefore, we determined that notice
and opportunity for public comment before issuing this AD are
impracticable and that good cause exists for making this amendment
effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2010-0851; Directorate
Identifier 2010-NM-171-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 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 this AD:
    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.

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 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 AD:

2010-18-11 Bombardier, Inc.: Amendment 39-16424. Docket No. FAA-
2010-0851; Directorate Identifier 2010-NM-171-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective
September 17, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Bombardier, Inc. Model CL-600-2C10
(Regional Jet Series 700, 701, & 702); Model CL-600-2D15 (Regional
Jet Series 705); and Model CL-600-2D24 (Regional Jet Series 900)
airplanes; certificated in any category; having horizontal
stabilizer trim actuators (HSTAs) with part number (P/N) 8489-7 or
8489-7R.

Subject

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

Reason

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

    During maintenance at the vendor's facility, some HSTAs were
assembled with the incorrect load bearing balls. The material of
these discrepant balls has lower wear characteristics and as such,
has a shorter expected life. If not corrected, this condition can
result in the HSTA jam leading to difficulties in controlling the
aircraft.
* * * * *
The unsafe condition is possible loss of controllability of the
airplane.

Compliance

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

Actions

    (g) Within 500 flight cycles after the effective date of this
AD: Inspect HSTAs having P/Ns 8489-7 and 8489-7R to determine if the
serial numbers (S/Ns) identified in paragraph 1.A., ``Effectivity,''
of Bombardier Service Bulletin 670BA-27-057, dated June 14, 2010,
are installed. A review of airplane maintenance records is
acceptable in lieu of this inspection if the serial number of the
HSTA can be conclusively determined from that review.
    (1) For any HSTA with a serial number that is not identified in
paragraph 1.A., ``Effectivity,'' of Bombardier Service Bulletin
670BA-27-057, dated June 14, 2010: No further action is required by
paragraph (g) of this AD.
    (2) For any HSTA with a serial number that is identified in
paragraph 1.A., ``Effectivity,'' of Bombardier Service Bulletin
670BA-27-057, dated June 14, 2010: Replace the HSTA with a
serviceable HSTA, in accordance with the Accomplishment Instructions
of Bombardier Service Bulletin 670BA-27-057, dated June 14, 2010, at
the applicable time specified by paragraph (g)(2)(i), (g)(2)(ii),
(g)(2)(iii), or (g)(2)(iv) of this AD.

    Note 1:  Bombardier Service Bulletin 670BA-27-057, dated June
14, 2010, references Sagem SA Service Bulletin 8489-27-006, dated
December 8, 2009, as an additional source of guidance for modifying
the HSTA. Sagem SA Service Bulletin 8489-27-006, dated December 8,
2009, references Ratier-Figeac Service Bulletin RF-DSC-075-07,
Version 03, dated November 10, 2009, as an additional source of
guidance for modifying the HSTA. The suffix ``A'' after the serial
number indicates serviceable HSTAs that have been modified.

    (i) For any HSTA that has accumulated less than or equal to
8,000 flight cycles as of the effective date of this AD: Before the
HSTA accumulates 10,000 flight cycles.
    (ii) For any HSTA that has accumulated more than 8,000 flight
cycles but less than or equal to 10,000 flight cycles as of the
effective date of this AD: Before the HSTA accumulates an additional
2,000 flight cycles, but no later than 11,000 flight cycles on the
HSTA.
    (iii) For any HSTA that has accumulated more than 10,000 flight
cycles but less than or equal to 12,000 flight cycles as of the
effective date of this AD: Before the HSTA accumulates an additional
1,000 flight cycles, but no later than 12,500 flight cycles on the
HSTA.
    (iv) For any HSTAs that has accumulated more than 12,000 flight
cycles as of the effective date of this AD: Before the HSTA
accumulates an additional 500 flight cycles.
    (h) As of the effective date of this AD, no person may install
an HSTA, having P/N 8489-7 or 8489-7R, with a serial number
identified in paragraph 1.A., ``Effectivity,'' of Bombardier Service
Bulletin 670BA-27-057, dated June 14, 2010, on any airplane.

FAA AD Differences

    Note 2:  This AD differs from the MCAI and/or service
information as follows: Canadian Airworthiness Directive CF-2010-20,
dated July 19, 2010, refers to an incorrect date of April 28, 2010,
for Bombardier Service Bulletin 670BA-27-057. The correct date for
Bombardier Service Bulletin 670BA-27-057 is June 14, 2010.

Other FAA AD Provisions

    (i) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to Attn: Program
Manager, Continuing Operational Safety, FAA, New York ACO, 1600
Stewart Avenue, Suite 410, Westbury, New York 11590; telephone 516-
228-7300; fax<PHONE_NUMBER>. 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.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to ensure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (j) Refer to MCAI Canadian Airworthiness Directive CF-2010-20,
dated July 19, 2010; and Bombardier Service Bulletin 670BA-27-057,
dated June 14, 2010; for related information.

Material Incorporated by Reference

    (k) You must use Bombardier Service Bulletin 670BA-27-057, dated
June 14, 2010, to do the actions required by this AD, unless the AD
specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; e-mail<EMAIL_ADDRESS>Internet http://
www.bombardier.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>.
    (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 August 20, 2010.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-21563 Filed 9-1-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 210 (Monday, October 31, 2011)]
[Notices]
[Page 67178]
[FR Doc No: 2011-28110]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2149-152]

Wells Hydroelectric Project; Notice of Availability of the Final
Environmental Impact Statement for the Wells Hydrolectric Project

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission (Commission or FERC)
regulations contained in the Code of Federal Regulations (CFR)(18 CFR
part 380 [FERC Order No. 486, 52 FR 47897]), the Office of Energy
Projects has reviewed the application for license for the Wells
Hydroelectric Project (FERC No. 2149), located on the Columbia River in
Douglas, Okanogan, and Chelan counties, Washington, and has prepared a
final environmental impact statement (EIS) for the project. The project
occupies 8.60 acres of U.S. Bureau of Land Management land and 6.55
acres of U.S. Army Corps of Engineers land.
    The final EIS contains staff's analysis of the applicant's proposal
and the alternatives for relicensing the Wells Project. The final EIS
documents the views of governmental agencies, non-governmental
organizations, affected Indian tribes, the public, the license
applicant, and Commission staff.
    A copy of the final EIS is available for review at the Commission
or may be viewed on the Commission's Web site at http://www.ferc.gov,
using the ``e-Library'' link. Enter the docket number, excluding the
last three digits, to access the document. For assistance, contact FERC
Online Support at<EMAIL_ADDRESS>or toll-free at (866) 208-
3676, or for TTY, contact<PHONE_NUMBER>.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    For further information, please contact Kim A. Nguyen at (202) 502-
6105 or at<EMAIL_ADDRESS>
    Dated: October 25, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-28110 Filed 10-28-11; 8:45 am]
BILLING CODE 6717-01-P