[Federal Register: May 16, 2006 (Volume 71, Number 94)]
[Notices]
[Page 28313-28314]
[DOCID:fr16my06-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP98-151-004]

Columbia Gas Transmission Corporation; Notice of Petition To
Amend

May 9, 2006.
    Take notice that on May 3, 2006, Columbia Gas Transmission
Corporation (Columbia), 1700 MacCorkle Avenue, SE., Charleston, West
Virginia 25314, filed in Docket No. CP98-151-004, an amendment to its
pending petition to amend filed on August 1, 2005, in Docket No. CP98-
151-003, pursuant to section 7 of the Natural Gas Act (NGA), to amend
the facilities previously approved for abandonment by conveyance to
Millennium Pipeline Company, L.L.C. (Millennium) and the lease of
capacity to Millennium. Specifically, Columbia states that it will now
retain ownership of Lines U, K, 1278, 1842 and will lease to Millennium
capacity in the facilities. In addition, Columbia states that it will
retain ownership in the Milford Compressor Station and Port Jervis
Measuring Station, all as more fully set forth in the petition which is
on file with the Commission and open to public inspection.
    This petition is on file with the Commission and open to public
inspection. This filing is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for
TTY, contact<PHONE_NUMBER>.
    Any questions regarding this petition should be directed to counsel
for Columbia, Fredric J. George, Columbia Gas Transmission Corporation,
P.O. Box 1273, Charleston, West Virginia 25325-1273; at<PHONE_NUMBER>
(phone) or<PHONE_NUMBER> (fax).
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date, file with the Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426, a motion to
intervene in accordance with the requirements of the Commission's Rules

of Practice and Procedure (18 CFR 385.214 or 385.211) and the
Regulations under the NGA (18 CFR 157.10). A person obtaining party
status will be placed on the service list maintained by the Secretary
of the Commission and will receive copies of all documents filed by the
applicant and by all other parties. A party must submit 14 copies of
filings made with the Commission and must mail a copy to the applicant
and to every other party in the proceeding. Only parties to the
proceeding can ask for court review of Commission orders in the
proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project, or in support of or in opposition to this project, should
submit an original and two copies of their comments to the Secretary of
the Commission. Environmental commenters will be placed on the
Commission's environmental mailing list, will receive copies of the
environmental documents, and will be notified of meetings associated
with the Commission's environmental review process. Environmental
commenters will not be required to serve copies of filed documents on
all other parties. The Commission's rules require that persons filing
comments in opposition to the project provide copies of their protests
only to the applicant. However, the non-party commenters will not
receive copies of all documents filed by other parties or issued by the
Commission (except for the mailing of environmental documents issued by
the Commission) and will not have the right to seek court review of the
Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See, 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.

    Comment Date: May 30, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-7372 Filed 5-15-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: January 13, 2006 (Volume 71, Number 9)]
[Notices]
[Page 2206]
[DOCID:fr13ja06-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP97-81-023]

Kinder Morgan Interstate Gas Transmission LLC; Notice of Tariff
Filing

January 6, 2006.
    Take notice that on December 30, 2005 Kinder Morgan Interstate Gas
Transmission LLC (KMIGT) tendered for filing as part of its FERC Gas
Tariff, Fourth Revised Volume No. 1-A, the following tariff sheets, to
be effective January 1, 2006:

Fourteenth Revised Sheet No. 4G
Third Revised Sheet No. 4G.01
Fifth Revised Sheet No. 4H
Fourth Revised Sheet No. 4I
Third Revised Sheet No. 4L

    KMIGT states that a copy of this filing has been served upon all
parties to this proceeding, KMIGT's customers and affected state
commissions.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing 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. Such protests
must be filed in accordance with the provisions of section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-289 Filed 1-12-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 74 (Monday, April 18, 2011)]
[Rules and Regulations]
[Pages 21622-21628]
[FR Doc No: 2011-9221]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 95

[Docket No. 30778; Amdt. No. 493]

IFR Altitudes; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This amendment adopts miscellaneous amendments to the required
IFR (instrument flight rules) altitudes and changeover points for
certain Federal airways, jet routes, or direct routes for which a
minimum or maximum en route authorized IFR altitude is prescribed. This
regulatory action is needed because of changes occurring in the
National Airspace System. These changes are designed to provide for the
safe and efficient use of the navigable airspace under instrument
conditions in the affected areas.

DATES: Effective Date: 0901 UTC, May 5, 2011.

FOR FURTHER INFORMATION CONTACT: Harry Hodges, Flight Procedure
Standards Branch (AMCAFS-420), Flight Technologies and Programs
Division, Flight Standards Service, Federal Aviation Administration,
Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd. Oklahoma
City, OK. 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This amendment to part 95 of the Federal
Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR
altitudes governing the operation of all aircraft in flight over a
specified route or any portion of that route, as well as the changeover
points (COPs) for Federal airways, jet routes, or direct routes as
prescribed in part 95.

The Rule

    The specified IFR altitudes, when used in conjunction with the
prescribed changeover points for those routes, ensure navigation aid
coverage that is adequate for safe flight operations and free of
frequency interference. The reasons and circumstances that create the
need for this amendment involve matters of flight safety and
operational efficiency in the National Airspace System, are related to
published aeronautical charts that are essential to the user, and
provide for the safe and efficient use of the navigable airspace. In
addition, those various reasons or circumstances require making this
amendment effective before the next scheduled charting and publication
date of the flight information to assure its timely availability to the
user. The effective date of this amendment reflects those
considerations. In view of the close and immediate relationship between
these regulatory changes and safety in air commerce, I find that notice
and public procedure before adopting this amendment are impracticable
and contrary to the public interest and that good cause exists for
making the amendment effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 95

    Airspace, Navigation (air).

    Issued in Washington, DC, on April 1, 2011.
John M. Allen,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me by the
Administrator, part 95 of the Federal Aviation Regulations (14 CFR part
95) is amended as follows effective at 0901 UTC, May 5, 2011.

PART 95--[AMENDED]

0
1. The authority citation for part 95 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44719, 44721.

0
2. Part 95 is amended to read as follows:

                                Revisions to IFR Altitudes and Changeover Points
                                   [Amendment 493 effective date, May 5, 2011]
----------------------------------------------------------------------------------------------------------------
                     From                                         To                        MEA          MAA
----------------------------------------------------------------------------------------------------------------
                                     Sec.   95.3000 Low Altitude RNAV Routes
----------------------------------------------------------------------------------------------------------------
                            Sec.   95.3231 RNAV Route T231 Is Amended To Read in Part
----------------------------------------------------------------------------------------------------------------
*FAIRBANKS, AK VORTAC.........................  HOBOM, AK FIX.........................         5100        17500
    *4300--MCA FAIRBANKS, AK VORTAC, W BND
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.3281 RNAV Route T281 Is Added To Read
----------------------------------------------------------------------------------------------------------------
YOZLE, NE FIX.................................  BOKKI, NE FIX.........................         4700        17500
BOKKI, NE FIX.................................  AINSWORTH, NE VOR/DME.................         4600        17500
AINSWORTH, NE VOR/DME.........................  LKOTA, SD FIX.........................         4400        17500
LKOTA, SD FIX.................................  PIERRE, SD VORTAC.....................         4300        17500
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.3283 RNAV Route T283 Is Added To Read
----------------------------------------------------------------------------------------------------------------
SCOTTSBLUFF, NE VORTAC........................  GORDON, NE NDB........................         6300        17500
GORDON, NE NDB................................  WNDED, SD FIX.........................        *5500        17500
    *5000--MOCA
WNDED, SD FIX.................................  PIERRE, SD VORTAC.....................         5000        17500
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.3285 RNAV Route T285 Is Added To Read
----------------------------------------------------------------------------------------------------------------
NORTH PLATTE, NE VORTAC.......................  THEDFORD, NE VOR/DME..................         5000        17500
THEDFORD, NE VOR/DME..........................  MARSS, NE FIX.........................         4900        17500
MARSS, NE FIX.................................  VALENTINE, NE NDB.....................         4800        17500
VALENTINE, NE NDB.............................  LKOTA, SD FIX.........................         4500        17500
LKOTA, SD FIX.................................  WINNER, SD VOR........................         4300        17500
WINNER, SD VOR................................  HURON, SD VORTAC......................         4000        17500
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.3286 RNAV Route T286 Is Added To Read
----------------------------------------------------------------------------------------------------------------
RAPID CITY, SD VORTAC.........................  GORDON, NE NDB........................         5700        17500
GORDON, NE NDB................................  EFFEX, NE FIX.........................         5600        17500
EFFEX, NE FIX.................................  THEDFORD, NE VOR/DME..................         5400        17500
THEDFORD, NE VOR/DME..........................  BOKKI, NE FIX.........................         4900        17500
BOKKI, NE FIX.................................  GRAND ISLAND, NE VORTAC...............         4600        17500
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.3288 RNAV Route T288 Is Added To Read
----------------------------------------------------------------------------------------------------------------
RAPID CITY, SD VORTAC.........................  WNDED, NE FIX.........................         5000        17500
WNDED, NE FIX.................................  VALENTINE, NE NDB.....................         5000        17500
VALENTINE, NE NDB.............................  AINSWORTH, NE VOR/DME.................        *4700        17500
    *4200--MOCA
AINSWORTH, NE VOR/DME.........................  FESNT, NE FIX.........................         4500        17500
FESNT, NE FIX.................................  WOLBACH, NE VORTAC....................         4300        17500
----------------------------------------------------------------------------------------------------------------
                                    Sec.   95.4000 High Altitude RNAV Routes
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.4120 RNAV Route Q120 Is Added To Read
----------------------------------------------------------------------------------------------------------------
SACRAMENTO, CA VORTAC.........................  ZORUN, NV FIX.........................  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
ZORUN, NV FIX.................................  GALLI, NV FIX.........................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
GALLI, NV FIX.................................  BIG PINEY, WY VOR/DME.................  *2        45000
                                                                                3000
    *18000--GNSS MEA
    DME/DME/IRU MEA
BIG PINEY, WY VOR/DME.........................  FOSIG, SD FIX.........................  *2        45000
                                                                                3000

    *18000--GNSS MEA
    DME/DME/IRU MEA
FOSIG, SD FIX.................................  REDWOOD FALLS, MN VOR/DME.............  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.4121 RNAV Route Q121 Is Added To Read
----------------------------------------------------------------------------------------------------------------
PARZZ, NV FIX.................................  POCATELLO, ID VOR/DME.................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
POCATELLO, ID VOR/DME.........................  TOUGH, MT FIX.........................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.4122 RNAV Route Q122 Is Added To Read
----------------------------------------------------------------------------------------------------------------
MOGEE, CA FIX.................................  MACUS, NV FIX.........................  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
MACUS, NV FIX.................................  MCORD, NV FIX.........................  *2        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
MCORD, NV FIX.................................  LUCIN, UT VORTAC......................  *2        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
LUCIN, UT VORTAC..............................  BEARR, UT FIX.........................  *2        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
BEARR, UT FIX.................................  KURSE, WY FIX.........................  *2        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
KURSE, WY FIX.................................  O'NEILL, NE VORTAC....................  *2        45000
                                                                                1000
    *18000--GNSS MEA
    DME/DME/IRU MEA
O'NEILL, NE VORTAC............................  FORT DODGE, IA VORTAC.................  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.4123 RNAV Route Q123 Is Added To Read
----------------------------------------------------------------------------------------------------------------
PARZZ, NV FIX.................................  COKEE, MT FIX.........................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.4124 RNAV Route Q124 Is Added To Read
----------------------------------------------------------------------------------------------------------------
MOGEE, CA FIX.................................  MACUS, NV FIX.........................  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
MACUS, NV FIX.................................  MCORD, NV FIX.........................  *2        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
MCORD, NV FIX.................................  SLOWN, NV FIX.........................  *2        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
SLOWN, NV FIX.................................  FASTE, NV FIX.........................  *2        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
FASTE, NV FIX.................................  BONNEVILLE, UT VORTAC.................  *2        45000
                                                                                3000
    *18000--GNSS MEA
    DME/DME/IRU MEA
BONNEVILLE, UT VORTAC.........................  WAATS, UT FIX.........................  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.4125 RNAV Route Q125 Is Added To Read
----------------------------------------------------------------------------------------------------------------
PARZZ, NV FIX.................................  WLLES, MT FIX.........................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------

                                 Sec.   95.4126 RNAV Route Q126 Is Added To Read
----------------------------------------------------------------------------------------------------------------
TIPRE, CA FIX.................................  INSLO, NV FIX.........................  *2        45000
                                                                                1000
    *18000--GNSS MEA
    DME/DME/IRU MEA
INSLO, NV FIX.................................  GAROT, UT FIX.........................  *2        45000
                                                                                6000
    *18000--GNSS MEA
    DME/DME/IRU MEA
GAROT, UT FIX.................................  MEEKER, CO VOR/DME....................  *1        45000
                                                                                9000
    *18000--GNSS MEA
    DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.4128 RNAV Route Q128 Is Added To Read
----------------------------------------------------------------------------------------------------------------
LINDEN, CA VORTAC.............................  JSICA, NV FIX.........................  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
JSICA, NV FIX.................................  EDLES, UT FIX.........................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
EDLES, UT FIX.................................  FLOOD, CO FIX.........................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
FLOOD, CO FIX.................................  ZAROS, CO FIX.........................  *2        45000
                                                                                0000
    *18000--GNSS MEA
    DME/DME/IRU MEA
ZAROS, CO FIX.................................  BARTLESVILLE, OK VOR/DME..............  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
BARTLESVILLE, OK VOR/DME......................  RAZORBACK, AR VORTAC..................  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
RAZORBACK, AR VORTAC..........................  PAMMO, AR FIX.........................  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
PAMMO, AR FIX.................................  MEMPHIS, TN VORTAC....................  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.4130 RNAV Route Q130 Is Added To Read
----------------------------------------------------------------------------------------------------------------
LINDEN, CA VORTAC.............................  JSICA, NV FIX.........................  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
JSICA, NV FIX.................................  REANA, NV FIX.........................  *2        45000
                                                                                9000
    *18000--GNSS MEA
    DME/DME/IRU MEA
REANA, NV FIX.................................  MRRNY, UT FIX.........................  *2        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
MRRNY, UT FIX.................................  RATTLESNAKE, NM VORTAC................  *2        45000
                                                                                2000
    *18000--GNSS MEA
    DME/DME/IRU MEA
RATTLESNAKE, NM VORTAC........................  DIXAN, NM FIX.........................  *2        45000
                                                                                2000
    *18000--GNSS MEA
    DME/DME/IRU MEA
DIXAN, NM FIX.................................  MIRME, NM FIX.........................  *2        45000
                                                                                2000
    *18000--GNSS MEA
    DME/DME/IRU MEA
MIRME, NM FIX.................................  PANHANDLE, TX VORTAC..................  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.4132 RNAV Route Q132 Is Added To Read
----------------------------------------------------------------------------------------------------------------
WEBGO, CA FIX.................................  ANAHO, NV FIX.........................  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
ANAHO, NV FIX.................................  MYBAD, NV FIX.........................  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA

MYBAD, NV FIX.................................  ZERAM, NV FIX.........................  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
ZERAM, NV FIX.................................  MAGPY, NV FIX.........................  *2        45000
                                                                                6000
    *18000--GNSS MEA
    DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.4134 RNAV Route Q134 Is Added To Read
----------------------------------------------------------------------------------------------------------------
DUGLE, CA FIX.................................  TATOO, NV FIX.........................  *2        45000
                                                                                0000
    *18000--GNSS MEA
    DME/DME/IRU MEA
TATOO, NV FIX.................................  JULIK, UT FIX.........................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
JULIK, UT FIX.................................  HERSH, UT FIX.........................  *2        45000
                                                                                1000
    *18000--GNSS MEA
    DME/DME/IRU MEA
HERSH, UT FIX.................................  VOAXA, CO FIX.........................  *2        45000
                                                                                1000
    *18000--GNSS MEA
    DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.4136 RNAV Route Q136 Is Added To Read
----------------------------------------------------------------------------------------------------------------
COALDALE, NV VORTAC...........................  RUMPS, NV FIX.........................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
RUMPS, NV FIX.................................  KATTS, NV FIX.........................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
KATTS, NV FIX.................................  WEEMN, UT FIX.........................  *2        45000
                                                                                6000
    *18000--GNSS MEA
    DME/DME/IRU MEA
WEEMN, UT FIX.................................  VOAXA, CO FIX.........................  *2        45000
                                                                                1000
    *18000--GNSS MEA
    DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.4138 RNAV Route Q138 Is Added To Read
----------------------------------------------------------------------------------------------------------------
WILLIAMS, CA VORTAC...........................  FIMUV, CA FIX.........................  *1        45000
                                                                                8000
    *18000--GNSS MEA
    DME/DME/IRU MEA
FIMUV, CA FIX.................................  JENSA, NV FIX.........................  *2        45000
                                                                                2000
    *18000--GNSS MEA
    DME/DME/IRU MEA
JENSA, NV FIX.................................  PUHGI, NV FIX.........................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
PUHGI, NV FIX.................................  ROOHZ, NV FIX.........................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
ROOHZ, NV FIX.................................  PARZZ, NV FIX.........................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
PARZZ, NV FIX.................................   UROCO, WY FIX........................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
UROCO, WY FIX.................................  RICCO, WY FIX.........................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
RICCO, WY FIX.................................  MOTLY, SD FIX.........................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
MOTLY, SD FIX.................................  ABERDEEN, SD VOR/DME..................  *2        45000
                                                                                4000
    *18000--GNSS MEA
    DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------

               From                           To                 MEA
------------------------------------------------------------------------
                   Sec.   95.6001 VICTOR Routes--U.S.
------------------------------------------------------------------------
    Sec.   95.6012 VOR Federal Airway V12 Is Amended To Read in Part
------------------------------------------------------------------------
HARRISBURG, PA VORTAC............  BOBSS, PA FIX...........         3100
BOBSS, PA FIX....................  POTTSTOWN, PA VORTAC....         3000
------------------------------------------------------------------------
    Sec.   95.6013 VOR Federal Airway V13 Is Amended To Read in Part
------------------------------------------------------------------------
MC ALLEN, TX VOR/DME.............  *MANNY, TX FIX..........       **5000
    *5000--MRA
    **1700--MOCA
------------------------------------------------------------------------
    Sec.   95.6044 VOR Federal Airway V44 Is Amended To Read in Part
------------------------------------------------------------------------
BENDS, WV FIX....................  MORGANTOWN, WV VORTAC...         4000
------------------------------------------------------------------------
    Sec.   95.6056 VOR Federal Airway V56 Is Amended To Read in Part
------------------------------------------------------------------------
COLUMBUS, GA VORTAC..............  *PRATZ, GA FIX..........         2500
    *3000--MRA
PRATZ, GA FIX....................  MACON, GA              *2500
                                    VORTAC.
    *GNSS MEA
    MACON R-265 UNUSABLE
     GNSS REQUIRED
------------------------------------------------------------------------
    Sec.   95.6070 VOR Federal Airway V70 Is Amended To Read in Part
------------------------------------------------------------------------
RAYMO, TX FIX....................  JIMIE, TX FIX...........        *4000
    *1600--MOCA
------------------------------------------------------------------------
    Sec.   95.6138 VOR Federal Airway V138 Is Amended To Read in Part
------------------------------------------------------------------------
BRADY, NE FIX....................  GAMBL, NE FIX...........         4100
------------------------------------------------------------------------
    Sec.   95.6159 VOR Federal Airway V159 Is Amended To Read in Part
------------------------------------------------------------------------
VIRGINIA KEY, FL VOR/DME.........  NITNY, FL FIX...........         2100
------------------------------------------------------------------------
    Sec.   95.6162 VOR Federal Airway V162 Is Amended To Read in Part
------------------------------------------------------------------------
HARRISBURG, PA VORTAC............  BOBSS, PA FIX...........         3100
------------------------------------------------------------------------
    Sec.   95.6195 VOR Federal Airway V195 Is Amended To Read in Part
------------------------------------------------------------------------
MANTECA, CA VOR/DME..............  TRACY, CA FIX...........
    NE BND.......................  ........................         2500
    SW BND.......................  ........................         4000
TRACY, CA FIX....................  SUNOL, CA FIX...........         5200
*RAGGS, CA FIX...................  **BESSA, CA FIX.........       **8500
    *8500--MRA
    **8500--MCA BESSA, CA FIX, S
     BND
    **4800--MOCA
------------------------------------------------------------------------
    Sec.   95.6198 VOR Federal Airway V198 Is Amended To Read in Part
------------------------------------------------------------------------
EAGLE LAKE, TX VOR/DME...........  BLUMS, TX FIX...........         2000
------------------------------------------------------------------------
    Sec.   95.6243 VOR Federal Airway V243 Is Amended To Read in Part
------------------------------------------------------------------------
LAGRANGE, GA VORTAC..............  HEFIN, AL FIX...........        *4000
    *3400--MOCA
------------------------------------------------------------------------
    Sec.   95.6257 VOR Federal Airway V257 Is Amended To Read in Part
------------------------------------------------------------------------
PHOENIX, AZ VORTAC...............  *AVENT, AZ FIX..........
    NW BND.......................  ........................         7000
    SE BND.......................  ........................         5000
    *8000--MRA
------------------------------------------------------------------------
    Sec.   95.6266 VOR Federal Airway V266 Is Amended To Read in Part
------------------------------------------------------------------------
SOUTH BOSTON, VA VORTAC..........  LAWRENCEVILLE, VA VORTAC        *3000
    *2000--MOCA
    *2300--GNSS MEA
LAWRENCEVILLE, VA VORTAC.........  FRANKLIN, VA VORTAC.....         2000
------------------------------------------------------------------------

    Sec.   95.6321 VOR Federal Airway V321 Is Amended To Read in Part
------------------------------------------------------------------------
LAGRANGE, GA VORTAC..............  HEFIN, AL FIX...........        *4000
    *3400--MOCA
------------------------------------------------------------------------
    Sec.   95.6520 VOR Federal Airway V520 Is Amended To Read in Part
------------------------------------------------------------------------
SALMON, ID VOR/DME...............  *DUBOIS, ID VORTAC......        13500
    *9000--MCA DUBOIS, ID VORTAC,
     E BND
    *10500--MCA DUBOIS, ID
     VORTAC, W BND
------------------------------------------------------------------------
    Sec.   95.6524 VOR Federal Airway V524 Is Amended To Read in Part
------------------------------------------------------------------------
LARAMIE, WY VOR/DME..............  SCOTTSBLUFF, NE VORTAC..       *12000
    *10900--MOCA
    *11000--GNSS MEA
------------------------------------------------------------------------
    Sec.   95.6533 VOR Federal Airway V533 Is Amended To Read in Part
------------------------------------------------------------------------
LAKELAND, FL VORTAC..............  *CAMBE, FL FIX..........         2000
    *4000--MRA
*CAMBE, FL FIX...................  ORLANDO, FL VORTAC......         2000
    *4000--MRA
------------------------------------------------------------------------
    Sec.   95.6558 VOR Federal Airway V558 Is Amended To Read in Part
------------------------------------------------------------------------
EAGLE LAKE, TX VOR/DME...........  BLUMS, TX FIX...........         2000
------------------------------------------------------------------------
           Sec.   95.8003 VOR Federal Airway Changeover Points
------------------------------------------------------------------------

                            Airway segment                                          Changeover points
----------------------------------------------------------------------------------------------------------------
                 From                                 To                  Distance               From
----------------------------------------------------------------------------------------------------------------
                                   V140 Is Amended To Delete Changeover Point
----------------------------------------------------------------------------------------------------------------
BLUEFIELD, WV VORTAC..................  MONTEBELLO, VA VOR/DME........           44  Bluefield
----------------------------------------------------------------------------------------------------------------
                                   V266 Is Amended To Modify Changeover Point
----------------------------------------------------------------------------------------------------------------
SOUTH BOSTON, VA VORTAC...............  LAWRENCEVILLE, VA VORTAC......           38  South Boston
----------------------------------------------------------------------------------------------------------------
                                   Sec.   95.8005 Jet Route Changeover Points
----------------------------------------------------------------------------------------------------------------
                                   J120 Is Amended To Modify Changeover Point
----------------------------------------------------------------------------------------------------------------
ST PAUL ISLAND, AK....................  BETHEL, AK VORTAC.............          190  St Paul Island
    NDB/DME
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2011-9221 Filed 4-15-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Rules and Regulations]
[Pages 43482-43485]
[FR Doc No: 2017-19602]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 558

[Docket No. FDA-2017-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor's Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for a
new animal drug application (NADA) and abbreviated new animal drug
applications (ANADAs) during March and April 2017. FDA is also
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to reflect a change of a
sponsor's address and to make technical amendments to improve the
accuracy of the regulations.

DATES: This rule is effective September 18, 2017.

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

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval
actions for a NADA and ANADAs during March and April 2017, as listed in
table 1. In addition, FDA is informing the public of the availability,
where applicable, of documentation of environmental review required
under the National Environmental Policy Act (NEPA) and, for actions
requiring review of safety or effectiveness data, summaries of the
basis of approval (FOI Summaries) under the Freedom of Information Act
(FOIA). These public documents may be seen in the Dockets Management
Staff Office (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday
through Friday. Persons with access to the internet may obtain these
documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be
accessed in FDA's publication, Approved Animal Drug Products Online
(Green Book) at: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                                Table 1--Original and Supplemental NADAs and ANADAs Approved During March and April 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
         Approval date           File No.       Sponsor        Product name        Species      Effect of the action           Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 24, 2017................    141-269  Intervet, Inc.,   REVALOR-XH        Cattle........  Supplemental approval  FOI Summary, EA/FONSI.\1\
                                            2 Giralda         (trenbolone                       of a new implant for
                                            Farms, Madison,   acetate and                       increased rate of
                                            NJ 07940.         estradiol                         weight gain and
                                                              extended-                         improved feed
                                                              release                           efficiency for up to
                                                              implant).                         200 days after
                                                                                implantation in beef
                                                                                heifers fed in
                                                                                confinement for
                                                                                slaughter.
April 19, 2017................    200-593  Accord            Carprofen         Dogs..........  Original approval as   FOI Summary.
                                            Healthcare,       Injection.                        a generic copy of
                                            Inc., 1009                                          NADA 141-199.
                                            Slater Rd.,
                                            Suite 210-B,
                                            Durham, NC
                                            27703.
April 28, 2017................    200-595  Norbrook          CARPRIEVE         Dogs..........  Original approval as   FOI Summary.
                                            Laboratories,     (carprofen)                       a generic copy of
                                            Ltd., Station     Chewable                          NADA 141-111.
                                            Works, Newry      Tablets.
                                            BT35 6JP,
                                            Northern
                                            Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
  no significant impact (FONSI).

II. Technical Amendments

    Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405, has
informed FDA that it has changed its address to 1800 Sir Tyler Dr.,
Wilmington, NC 28405. Accordingly, we are amending Sec.  510.600(c) to
reflect this change.
    We are making several technical amendments in part 558, which was
amended on December 27, 2016 (81 FR 94991), and February 24, 2017 (82
FR 11510), as part of the FDA Center for Veterinary Medicine's (CVM's)
Judicious Use Initiative. We are also making several technical
amendments to the regulations for dosage form drugs. These actions are
being taken to improve the accuracy of the regulations.

III. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(i)), which
requires Federal Register publication of ``notice[s] . . . effective as
a regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 524

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, 522, 524, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), revise the entry
for ``Pharmgate LLC''; and in the table in paragraph (c)(2), revise the
entry for ``069254'' to read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                                 Drug
                    Firm name and address                       labeler
                                                                 code
------------------------------------------------------------------------

                                * * * * *
Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405.....     069254

                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
        Drug labeler code                  Firm name and address
------------------------------------------------------------------------

                                * * * * *
069254...........................  Pharmgate LLC, 1800 Sir Tyler Dr.,
                                    Wilmington, NC 28405

                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for part 520 continues to read as follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.88g  [Amended]

0
4. In Sec.  520.88g, in paragraphs (c)(1)(ii) and (c)(2)(ii), in the
first sentence, remove ``nonbeta-lactamase'' and in its place add
``non-beta-lactamase''.

0
5. In Sec.  520.304, remove paragraph (b)(3) and revise paragraphs
(b)(1) and (2) to read as follows:

Sec.  520.304  Carprofen.

* * * * *
    (b) * * *
    (1) Nos. 054771, 026637, 055529, and 062250 for use of products
described in paragraph (a) as in paragraph (d) of this section.
    (2) No. 000859 for use of product described in paragraph (a)(1) as
in paragraph (d) of this section.
* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
6. The authority citation for part 522 continues to read as follows:

    Authority: 21 U.S.C. 360b.

0
7. In Sec.  522.304, revise paragraph (b) to read as follows:

Sec.  522.304   Carprofen.

* * * * *
    (b) Sponsors. See Nos. 016729, 026637, 054771, and 055529 in Sec.
510.600(c) of this chapter.
* * * * *

0
8. In Sec.  522.970, revise paragraph (b)(1); remove paragraphs (b)(3),
(e)(2)(ii)(B), and (e)(2)(iii); and add two sentences after the italic
heading of paragraph (e)(2)(ii), to read as follows:

Sec.  522.970  Flunixin.

* * * * *
    (b) * * *
    (1) See Nos. 000061, 000859, 055529, 057561, and 061623 for use as
in paragraph (e) of this section.
* * * * *
    (e) * * *
    (2) * * *
    (ii) Limitations. Approved only for intravenous administration in
cattle. Intramuscular administration has resulted in violative residues
in the edible tissues of cattle sent to slaughter. * * *
* * * * *

0
9. In Sec.  522.1002, revise paragraph (b)(1) to read as follows:

Sec.  522.1002  Follicle stimulating hormone.

* * * * *
    (b)(1) Specifications--(i) Single pack. Each package contains 2
vials. One vial contains 700 international units (IU) porcine-
pituitary-derived follicle stimulating hormone (FSH) equivalent to 400
milligrams NIH-FSH-P1, as a dry powder. The other vial contains 20
milliliters (mL) of bacteriostatic sodium chloride injection. When
constituted, each milliliter of solution contains 35 IU FSH.
    (ii) Dual pack. Each package contains 2 vials. Each vial contains
700 international units (IU) porcine-pituitary-derived FSH equivalent
to 400 milligrams NIH-FSH-P1, as a dry powder. Constitute with 20 mL
bacteriostatic sodium chloride injection, using strict aseptic
technique. When constituted, each milliliter of solution contains 35 IU
FSH.
* * * * *

0
10. In Sec.  522.1660a, revise the first sentence of paragraph
(e)(1)(ii) to read as follows:

Sec.  522.1660a  Oxytetracycline solution, 200 milligrams/milliliter.

* * * * *
    (e) * * *
    (1) * * *
    (ii) Limitations. Exceeding the highest recommended level of drug
per pound of bodyweight per day, administering more than the
recommended number of treatments, and/or exceeding 10 mL
intramuscularly or subcutaneously per injection site in adult beef and
dairy cattle may result in antibiotic residues beyond the withdrawal
time. * * *
* * * * *

0
11. In Sec.  522.2477, revise paragraph (b)(2) and the first sentence
in paragraphs (d)(1)(iii), (d)(2)(iii), (d)(3)(iii), and (d)(4)(iii);
and add paragraph (d)(5) to read as follows:

Sec.  522.2477  Trenbolone acetate and estradiol.

* * * * *
    (b) * * *
    (2) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C),
(d)(1)(i)(D), (d)(1)(i)(G), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A),
(d)(2)(i)(C), (d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A),
(d)(3)(ii), (d)(3)(iii), (d)(4), and (d)(5) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Administer implant subcutaneously in the ear
only. * * *
    (2) * * *
    (iii) Limitations. Administer implant subcutaneously in the ear
only. * * *
    (3) * * *
    (iii) Limitations. Administer implant subcutaneously in the ear
only. * * *
    (4) * * *
    (iii) Limitations. Administer implant subcutaneously in the ear
only. * * *
    (5) Beef heifers fed in confinement for slaughter--(i) Amount. Each
extended-release implant contains 200 mg trenbolone acetate and 20 mg
estradiol (one implant consisting of 6 coated and 4 uncoated pellets,
each pellet containing 20 mg trenbolone acetate and 2 mg estradiol).
    (ii) Indications for use. For increased rate of weight gain and
improved feed efficiency for up to 200 days after implantation.
    (iii) Limitations. Administer implant subcutaneously in the ear
only. Do not use in lactating dairy cows or in animals intended for
subsequent breeding. Use in these cattle may cause drug residues in
milk and/or in calves born to these cows. Do not use in calves to be
processed for veal. A withdrawal period has not been established for
this product in pre-ruminating calves. Effectiveness

and animal safety in veal calves have not been established. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant during the production phase(s) identified on
labeling (beef heifers fed in confinement for slaughter) unless
otherwise indicated on labeling because safety and effectiveness have
not been evaluated.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
12. The authority citation for part 524 continues to read as follows:

    Authority: 21 U.S.C. 360b.

0
13. In Sec.  524.998, add paragraph (c)(2) to read as follows:

Sec.  524.998  Fluralaner.

* * * * *
    (c) * * *
    (2) Cats--(i) Amount. Administer topically as a single dose every
12 weeks according to the label dosage schedule to provide a minimum
dose of 18.2 mg/lb (40 mg/kg) body weight. May be administered every 8
weeks in case of potential exposure to D. variabilis ticks.
    (ii) Indications for use. Kills adult fleas; for the treatment and
prevention of flea infestations (C. felis) and the treatment and
control of I. scapularis (black-legged tick) infestations for 12 weeks
in cats and kittens 6 months of age and older, and weighing 2.6 lb or
greater; for the treatment and control of D. variabilis (American dog
tick) infestations for 8 weeks in cats and kittens 6 months of age and
older, and weighing 2.6 lb or greater.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
14. The authority citation for part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
15. In Sec.  558.4, in paragraph (d), in the ``Category II'' table,
revise the row entries for ``Neomycin'' and ``Oxytetracycline'' to read
as follows:

Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                                 Assay limits                                      Assay limits
                     Drug                       percent Type A        Type B maximum (100x)       percent Type B/
                                                      \1\                                              C \2\
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Neomycin......................................          80-120  20 g/lb (4.4%)..................          70-125
Oxytetracycline...............................          80-120  20 g/lb (4.4%)..................          65-135

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
  range limit, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
  These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
  medicated feed with lower assay limits to make a Type C medicated feed.

* * * * *

Sec.  558.128  [Amended]

0
16. In Sec.  558.128, in paragraphs (e)(4)(iii) and (xii) and
(e)(5)(ii) and (iii), in the ``Sponsor'' column, add ``069254'' after
``054771''; in paragraphs (e)(4)(xi) and (xiii), in the ``Limitations''
column, remove the third sentence ``Withdraw 24 hours prior to
slaughter.''; and in paragraph (e)(6)(v), remove ``Sponsor. See No.
054771'' and in its place add ``Sponsors. See Nos. 054771 and 069254''.

Sec.  558.625  [Amended]

0
17. Amend Sec.  558.625 as follows:
0
a. In paragraphs (e)(1)(vii) and (ix), in the ``Tylosin grams/ton''
column, remove ``40 to 100'' and in its place add ``40 or 100'';
0
b. In paragraph (e)(2)(ii), in the ``Limitations'' column, add ``See
Sec. Sec.  558.311(d) and 558.342(d) in this chapter.'' after the last
sentence;
0
c. In paragraph (e)(2)(iii), in the ``Limitations '' column, add ``See
Sec.  558.342(d) in this chapter.'' after the last sentence;
0
d. In paragraph (e)(2)(vi), in the ``Limitations'' column, remove ``See
Sec.  558.355(d) in this chapter'' and in its place add ``See
Sec. Sec.  558.311(d) and 558.355(d) in this chapter.'';
0
e. In paragraph (e)(2)(vii), in the ``Limitations'' column, remove
``See Sec.  558.355(d) in this chapter'' and in its place add ``See
Sec. Sec.  558.342(d) and 558.355(d) in this chapter.'';
0
f. In paragraphs (e)(2)(viii), (ix), and (x), in the ``Limitations''
column, remove ``See Sec.  558.355(d) in this chapter'' and in its
place add ``See Sec. Sec.  558.355(d) and 558.500(d) in this chapter.''
0
g. In paragraph (e)(2)(xi) in the ``Limitations'' column, remove ``See
Sec.  558.355(d) in this chapter.'' and in its place add ``See
Sec. Sec.  558.342(d), 558.355(d), and 558.500(d) in this chapter.'';
0
h. In paragraphs (e)(2)(xii) and (xiii), in the ``Limitations'' column,
remove ``See Sec.  558.355(d) in this chapter.'' and in its place add
``See Sec. Sec.  558.355(d) and 558.665(d) in this chapter.''; and
0
i. In paragraphs (e)(2)(xiv) and (xv), in the ``Limitations'' column,
remove ``See Sec.  558.355(d) in this chapter.'' and in its place add
``See Sec. Sec.  558.342(d), 558.355(d) and 558.665(d) in this
chapter.''

    Dated: September 7, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19602 Filed 9-15-17; 8:45 am]
 BILLING CODE 4164-01-P


ICR Supporting Statement
Information Collection Request for EPA Application Materials for the Water Infrastructure Finance and Innovation Act
OMB Control No. 2040-RENEWAL, EPA ICR No. 2549.02

A.  Justification.

       Explain the circumstances that make the collection of information necessary.  Identify any legal or administrative requirements that necessitate the collection.

      The collection of information is necessary to receive applications for credit assistance pursuant to section 5024 of the Water Infrastructure Finance and Innovation Act (WIFIA) of 2014, 33 USC 3903. The purpose of the WIFIA program is to provide Federal credit assistance in the form of direct loans and loan guarantees to eligible clean water and drinking water projects. In addition, America's Water Infrastructure Act of 2018 passed on October 10, 2018 reauthorized the WIFIA program and created a separate loan program specifically for State Revolving Fund (SRF) programs. Therefore, the collection of information is necessary to receive applications for the SRF WIFIA (SWIFIA) program currently under development, pending appropriation.

      WIFIA requires that an eligible entity shall submit to the Administrator an application at such time, in such manner, and containing such information, as the Secretary or the Administrator may require to receive assistance under WIFIA. To satisfy these requirements, EPA must collect a Letter of Interest (LOI) and an application from entities seeking funding. The relevant section of WIFIA is attached hereto as Exhibit A. EPA is publishing this notice to give entities an opportunity to submit application materials upon appropriation of funding for the WIFIA program and/or the SWIFIA program. This collection is necessary to determine whether each proposed project meets creditworthiness and other Federal requirements to receive WIFIA credit assistance.

 2.	Indicate how, by whom, and for what purpose the information is to be used.  Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.

      The LOI and the application for the base WIFIA program and SWIFIA program (attached as Exhibits B, C, D, and E) collected from prospective borrowers through this solicitation will be used to evaluate applications for credit assistance under the WIFIA eligibility requirements and selection criteria as outlined in the annual Notice of Funding Availability (NOFA).

3.	Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.

	The LOI form is available electronically. To reduce burden and reduce the number of copies required, the LOI and supporting documents are submitted via WIFIA's SharePoint site or e-mail. The application is available electronically. It is also submitted electronically via WIFIA's SharePoint site.

 4.	Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purpose(s) described in item 2 above.

      The LOIs and applications will generally be project specific and the information is not available elsewhere. Applicants may reference documents that already exist and submit the documents as attachments as part of the LOI and application process.

 5.	If the collection of information impacts small businesses or other small entities (item 5 of the OMB form 83-1), describe the methods used to minimize burden.

      Eligible applicants under WIFIA include corporations, partnerships, joint ventures, trusts, Federal, State, or local governmental entities, agencies, or instrumentalities, tribal governments or consortium of tribal governments, and state infrastructure financing authorities, which could include small entities. LOIs and applications are voluntary. EPA cannot minimize the burden to small entities, because WIFIA requires all eligible entities to submit an application in order to receive credit assistance. The relevant section of WIFIA is attached hereto as Exhibit A.

 6.	Describe the consequence to federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

      If the collection is not conducted, EPA will be unable to satisfy the statutory mandate to require the submission of applications. Therefore, WIFIA credit assistance will not be available. To provide credit assistance to eligible projects, which is the purpose of the program, EPA must collect letters of interest and applications that respond to the eligibility requirements and selection criteria.

 7.	Explain any special circumstances that would cause an information collection to be conducted in a manner inconsistent with 5 CFR 1320.6:

      There are no special circumstances. The collection of information is conducted in a manner consistent with the guidelines in 5 CFR 1320.6.

8.	Efforts to consult with persons outside the agency to obtain their views

      On DATE OF PUBLICATION (Month, day, and year), Vol. No. _____, pages __________ to __________, the Agency published the notice of information collection and request for comments in the Federal Register. The solicitation is attached as Exhibit D. ________ comments were received.

      EPA will consult with persons outside the Agency to obtain their views on the availability of data, frequency of recordkeeping, disclosure, or reporting format, and on the data elements to be recorded, disclosed, or reported.

 9.	Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

       No payments or gifts are provided to respondents.

10.	Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

      EPA cannot offer an assurance of confidentiality to any applicant. The applicant is directed to state if any information submitted in its LOI, application, or any supplementary material may not be released by the Agency upon request from a member of the public or otherwise made publicly available. The applicant must identify the confidential business information and provide reasons why such information is confidential business information and should not be released, including particulars as to any competitive harm which would potentially result from the release of such information. The Agency will handle requests from the public for release of information under its standard Freedom of Information Act procedures.

11.	Provide additional justification for any questions of a sensitive nature.

      Questions of a sensitive nature are not found in this information collection.

12.		Provide estimates of the hour burden of the collection of information.
      Based on respondent numbers and burden data from the WIFIA's 2017 and 2018 rounds of collecting LOIs and applications, EPA is estimating the burden below.

      LOI (Base Program & SWIFIA):
                              LOI Burden per LOI
Function
Legal
Manager
Technical
Clerical
Read LOI guidelines

                                                                              1
                                                                              1
                                                                              1
Gather Information

                                                                              8
                                                                              3
Complete basic LOI form

                                                                              1
Complete narrative

                                                                             18

Review LOI
                                                                              5
                                                                              5

Compile LOI

                                                                              2
TOTAL
                                                                              5
                                                                              6
                                                                             27
                                                                              7
 Total number of unduplicated respondents: 60
 Frequency of response: one per respondent
 Annual hour burden per application: 45
 Total annual burden hours: 2,700

	Application for Borrowers (Base Program & SWIFIA):
                      Application Burden per Application

Legal
Manager
Technical
Clerical
Read application guidelines

                                                                              1
                                                                              1
                                                                              1
Gather Information

                                                                             25
                                                                              5
Complete application form

                                                                              1
Complete narrative

                                                                            100

Review Application
                                                                              4
                                                                             10

Compile Application

                                                                              2
TOTAL
                                                                              4
                                                                             11
                                                                            126
                                                                              9

 Total number of unduplicated respondents:  40
 Frequency of response: one per respondent
 Annual hour burden per application: 150
 Total annual burden hours: 6,000

13.		Provide an estimate of the total annual cost burden to respondents or recordkeepers resulting from the collection of information.

      EPA estimates that the total annual cost burden to respondents will be $15,109,113.40. The tables below show the breakdown in these costs for the LOIs, Applications, and other Application Costs. The numbers in blue in the tables below add up to the total annual cost of $15,109,113.40. This estimate includes the following:

      LOIs (Base Program & SWIFIA)

      For the LOI, EPA estimates 2,700 annual burden hours and the annualized cost of those hours is $110,727.

Number of Collections per year
Hours per Collection
Total Hours per Collection
Total Cost per year
60
45
2,700
$110,727

      Applications (Base Program & SWIFIA)

      For the application, EPA estimates 6,000 annual burden hours and the annualized cost of those hours is $248,386.40.

Number of Collections per year
Hours per Collection
Total Hours per Collection
Total Cost per year
40
150
6,000
$248,386.40

      Note: EPA used the following median hourly wages from the May 2017 National Occupational Employment and Wage Estimates United States (http://www.bls.gov/oes/current/oes_nat.htm) from the U.S. Bureau of Labor Statistics to calculate the cost of the estimated burden hours:
 Lawyers= $57.33
 Management= $50.77
 Engineers= $41.73
 Office and Administrative Support= $18.21

      Application Costs  -  Other

      	In addition, applicants will be charged two fees. An application fee will be due upon submission of the application. For applications for projects serving small communities (population of not more than 25,000 people), this application fee will be $25,000. For all other applicants, this application fee will be $100,000. A credit processing fee will be due upon loan closing, to reimburse costs incurred by the EPA due to legal, financial, and other expert contractor help. Due to the nature of this fee, the amount is expected to vary between applicants. However, EPA estimates these costs based on the FY 2017 borrowers as approximately $275,000 per applicant, a portion of which may be waived at the discretion of the EPA. The application fee is considered a down payment to the credit processing fees. The total fees, given the down payment of the application fee (per borrower) would be $350,000. The total for 40 borrowers, estimating 3 small community borrowers, 32 large community borrowers, and 5 SWIFIA borrowers is $11,000,000.

      By statute, applicants to the base WIFIA program are required to submit a preliminary rating letter at the time of application and two (2) final rating letters at the time of closing that indicate that the senior obligation of the project has an investment grade rating. The cost of these rating letters vary based on the size and complexity of the project. Based on bond rating agency estimates and industry research, EPA estimates that the final rating letters will cost approximately $50,000 per letter and that the initial preliminary rating letter is included in the cost of one of the final letters. The total cost for 35 applicants (3 small community borrowers and 32 large community borrowers) is $3,500,000. Applicants to the SWIFIA program are required to submit a preliminary rating letter at the time of application and one (1) final rating letters at the time of closing that indicate that the senior obligation of the project has an investment grade rating. These rating letters must be from a bond rating agency identified by the Securities and Exchange Commission as a Nationally Recognized Statistical Rating Organization. The total cost for 5 applicants will be $250,000.

Large Community
Cost
# of Applications

Application Fee + Credit Processing Fee
 $275,000
                                                                             32
 $8,800,000
Two Rating Letters
 $100,000
                                                                             32
 $3,200,000
Annual Total per borrower
$375,000
 Annual Total
 $12,000,000

Small Community
Cost
# of Applications

Application Fee + Credit Processing Fee
 $275,000
                                                                              3
 $825,000
Two Rating Letters
 $50,000
                                                                              3
 $300,000
Annual Total per borrower
$325,000
 Annual Total
 $1,125,000

SWIFIA
Cost
# of Applications

Application Fee + Credit Processing Fee
 $275,000
                                                                              5
 $1,375,000
One Rating Letter
 $50,000
                                                                              5
 $250,000
Annual Total per borrower
$325,000
 Annual Total
 $1,625,000

14.	Provide estimates of annualized cost to the federal government.
	The estimated cost to the Federal government of this request for letters of interest and applications is $3,512,217.76. This cost reflects three components:

 EPA follows an evaluation process to review each LOI and application and to determine which projects will receive WIFIA funding. This process includes technical, financial, and management review of the letters of interest. Then, additional technical, financial, and management review of the applications. EPA estimates that this process will take 65% of the 26 FTE's time employed by WIFIA.

      The estimated average annual cost for EPA personnel is $129,869 based on the General Schedule (GS) 14, Step 05 level from the 2018 GS salary table. The annual cost was then multiplied by the standard government benefits multiplication factor of 1.6 to calculate an estimated annual pay including benefits per FTE of $207,790.40. Therefore, the estimated annualized cost for the evaluation team is $3,511,657.76.

 EPA will hire legal, financial, and other expert contractor support for credit processing. These costs are estimated to be $275,000 per application and are expected to be reimbursed in full by the applicants. The net estimated annualized cost to the Federal Government for credit processing is $0.

 EPA will print application materials. EPA does not expect to need any special equipment or support, other than printing. As noted above in item 12, EPA expects 60 letters of interest and 40 applications. If each LOI is 25 pages and each application is 50 pages, as requested in the solicitation, EPA may need to print as many as 3,500 pages for staff involved in the evaluation process. EPA estimates up to 8 staff may need materials which adds up to a total of 28,000 pages of printing. EPA's printing costs are approximately 2 cents per page, which adds up to a total printing cost of $560.

       Explain the reason for any program changes or adjustments reported in items 13 or 14 of the OMB form 83-1.

      For the respondent burden in item 13, the annual cost increased compared to the previous submission of OMB form 83-1. Since program inception, EPA received more LOIS and applications than it originally estimated. EPA estimated the program would receive 20 LOIs and 5 applications. This was based on the amount of budget authority initially authorized for WIFIA. However, in 2017, the program received 43 LOIs and invited 12 prospective borrowers to apply. In 2018, the program received 62 LOIs and invited 39 prospective borrowers to apply. In addition, EPA is including the newly authorized State Revolving Fund WIFIA (SWIFIA) program as part of this ICR renewal. EPA estimates that WIFIA will receive 5 LOIs and 5 applications through SWIFIA.

      For the cost to the federal government, EPA's annual cost increased for the same reason as for item 13. It received more LOIs and applications then initially anticipated. Due to the large number of LOIs and applications, EPA has since hired more WIFIA staff to meet the burden of these reviews. Due to the nature of the work, the majority of WIFIA staff are legal, financial and technical experts with salaries that are high on the GS scale. This also increases the cost.
       For collections of information whose results will be published, outline plans for tabulation, and publication.

      The letters of interest and applications collected for the WIFIA program will not be published. EPA will maintain a publicly available list of projects that have submitted letters of interest and applications to the WIFIA program. The current lists are available at https://www.epa.gov/wifia/wifia-financing-requests.
17.	If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

      The Agency plans to display the expiration date for OMB approval of the information collection on all instruments.

18.	Explain each exception to the certification statement identified in item 19, "certification for paperwork reduction act submissions," of OMB form 83-1.

      The Agency is able to certify compliance with all provisions under Item 19 of OMB Form 83-I."


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

General Comment:Population pharmacodynamic modeling of various extendedrelease formulations of methylphenidate in children with attention deficit hyperactivity disorder via meta-analysis. .