[Federal Register Volume 83, Number 6 (Tuesday, January 9, 2018)]
[Rules and Regulations]
[Pages 971-974]
[FR Doc No: 2018-00130]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

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Federal Register / Vol. 83, No. 6 / Tuesday, January 9, 2018 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 95

[Docket No. 31174; Amdt. No. 537]

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, Feburary 1, 2018.

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 December 29, 2017.
John S. Duncan,
Executive 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, Feburary 01, 2018.

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 & Changeover Point
             [Amendment 537 effective date February 1, 2018]
------------------------------------------------------------------------
              From                          To                  MEA
------------------------------------------------------------------------
                   Sec.   95.6001 Victor Routes--U.S.
     Sec.   95.6006 VOR Federal Airway V6 Is Amended To Read In Part
------------------------------------------------------------------------
PHILIPSBURG, PA VORTAC.........  SELINSGROVE, PA VOR/DME            4100
SELINSGROVE, PA VOR/DME........  SNOWY, PA FIX..........           *5000
------------------------------------------------------------------------
     *4000--GNSS MEA
------------------------------------------------------------------------
    Sec.   95.6012 VOR Federal Airway V12 Is Amended To Read In Part
------------------------------------------------------------------------
NEWCOMERSTOWN, OH VOR/DME......  *ALLEGHENY, PA VOR/DME.            3300
     *10000--MCA...............  ALLEGHENY, PA VOR/DME,
                                  E BND.

    ALLEGHENY, PA VOR/DME......  *JOHNSTOWN, PA VORTAC..          #10000
     *10000--MCA...............  JOHNSTOWN, PA VORTAC, W
                                  BND.
     #ALLEGHENY R-096..........  UNUSABLE USE JOHNSTOWN
                                  R-274.
JOHNSTOWN, PA VORTAC...........  HARRISBURG, PA VORTAC..            5400
------------------------------------------------------------------------
    Sec.   95.6030 VOR Federal Airway V30 Is Amended To Read In Part
------------------------------------------------------------------------
PHILIPSBURG, PA VORTAC.........  SELINSGROVE, PA VOR/DME            4100
------------------------------------------------------------------------
    Sec.   95.6031 VOR Federal Airway V31 Is Amended To Read In Part
------------------------------------------------------------------------
SELINSGROVE, PA VOR/DME........  WATSO, PA FIX..........           *3500
     *3100--MOCA
------------------------------------------------------------------------
       Sec.   95.6063 VOR Federal Airway V63 Is Amended By Adding
------------------------------------------------------------------------
GAMPS, AR FIX..................  BILIE, MO FIX..........           *4000
     *3200--MOCA
------------------------------------------------------------------------
    Sec.   95.6105 VOR Federal Airway V105 Is Amended To Read In Part
------------------------------------------------------------------------
BOULDER CITY, NV VORTAC........  *LAS VEGAS, NV VORTAC..            6000
     *10500--MCA LAS VEGAS, NV   VORTAC, W BND..........
LAS VEGAS, NV VORTAC...........  HARLS, NV FIX..........
                                 E BND..................            7000
                                 W BND..................           14000
HARLS, NV FIX..................  LUCKY, NV FIX..........
                                 E BND..................           11000
                                 W BND..................           14000
LUCKY, NV FIX..................  *HIDEN, CA FIX.........           14000
     *14000--MRA...............
     *14000--MCA HIDEN, CA.....  FIX, E BND.............
*HIDEN, CA FIX.................  BEATTY, NV VORTAC......         **12000
     *14000--MRA
     **8600--MOCA
------------------------------------------------------------------------
    Sec.   95.6106 VOR Federal Airway V106 Is Amended To Read In Part
------------------------------------------------------------------------
JOHNSTOWN, PA VORTAC...........  HUDON, PA FIX..........            5000
HUDON, PA FIX..................  *RASHE, PA FIX.........          **7000
     *14000--MCA RASHE, PA       FIX, E BND.............
     **4000--MOCA
     **4000--GNSS MEA
RASHE, PA FIX..................  SELINSGROVE, PA VOR/DME           14000
------------------------------------------------------------------------
    Sec.   95.6135 VOR Federal Airway V135 Is Amended To Read In Part
------------------------------------------------------------------------
NEEDLES, CA VORTAC.............  *GOFFS, CA VORTAC......          **8000
     *9600--MCA GOFFS, CA......  VORTAC, NW BND.........
     **7100--MOCA
GOFFS, CA VORTAC...............  *WHIGG, CA FIX.........         **12000
     *12000--MRA
     **10000--MOCA
*WHIGG, CA FIX.................  CLARR, CA FIX..........         **12000
     *12000--MRA
     **10500--MOCA
CLARR, CA FIX..................  *HIDEN, CA FIX.........         **12000
     *14000--MRA
     **9100--MOCA
*HIDEN, CA FIX.................  BEATTY, NV VORTAC......         **12000
     *14000--MRA
     **8600--MOCA
------------------------------------------------------------------------
    Sec.   95.6170 VOR Federal Airway V170 Is Amended To Read In Part
------------------------------------------------------------------------
SELINSGROVE, PA VOR/DME........  RAVINE, PA VORTAC......           *4000
     *3400--MOCA
------------------------------------------------------------------------
    Sec.   95.6188 VOR Federal Airway V188 Is Amended To Read In Part
------------------------------------------------------------------------
SWANK, PA FIX..................  WILKES-BARRE, PA VORTAC
                                 E BND..................           *4000

                                 W BND..................           *4500
 *3700--MOCA
------------------------------------------------------------------------
    Sec.   95.6217 VOR Federal Airway V217 Is Amended To Read In Part
------------------------------------------------------------------------
RHINELANDER, WI VOR/DME........  DULUTH, MN VORTAC......           *6000
     *4100--MOCA
------------------------------------------------------------------------
    Sec.   95.6226 VOR Federal Airway V226 Is Amended To Read In Part
------------------------------------------------------------------------
SWANK, PA FIX..................  WILKES-BARRE, PA VORTAC
                                 E BND..................           *4000
                                 W BND..................           *4500
     *3700--MOCA
------------------------------------------------------------------------
    Sec.   95.6297 VOR Federal Airway V297 Is Amended To Read In Part
------------------------------------------------------------------------
JOHNSTOWN, PA VORTAC...........  TALLS, PA FIX..........            4400
------------------------------------------------------------------------
    Sec.   95.6301 VOR Federal Airway V301 Is Amended To Read In Part
------------------------------------------------------------------------
RUMSY, CA FIX..................  WILLIAMS, CA VORTAC....
                                 SW BND.................            7000
                                 NE BND.................            5300
------------------------------------------------------------------------
    Sec.   95.6469 VOR Federal Airway V469 Is Amended To Read In Part
------------------------------------------------------------------------
MORGANTOWN, WV VORTAC..........  *NESTO, PA FIX.........          **5000
     *10000--MCA NESTO, PA.....  FIX, E BND.............
     **4300--MOCA
NESTO, PA FIX..................  *JOHNSTOWN, PA VORTAC..           10000
     *10000--MCA JOHNSTOWN, PA.  VORTAC, W BND..........
JOHNSTOWN, PA VORTAC...........  ST THOMAS, PA VORTAC...           #5000
 #JOHNSTOWN R-125                UNUSABLE, USE ST THOMAS
                                  R-307.
------------------------------------------------------------------------
    Sec.   95.6509 VOR Federal Airway V509 Is Amended To Read In Part
------------------------------------------------------------------------
ST PETERSBURG, FL VORTAC.......  *CROWD, FL FIX.........          **5000
     *5000--MRA
     **2700--MOCA
------------------------------------------------------------------------
    Sec.   95.6528 VOR Federal Airway V528 Is Amended To Read In Part
------------------------------------------------------------------------
EAGUL, AZ FIX..................  *PAYSO, AZ FIX.........         **16000
     *16000--MCA PAYSO, AZ.....  FIX, SW BND............
     **10000--MOCA
------------------------------------------------------------------------

                        Airway Segment                                         Changeover Points
----------------------------------------------------------------------------------------------------------------
                From                             To              Distance                   From
----------------------------------------------------------------------------------------------------------------
                               Sec.   95.8003 VOR Federal Airway Changeover Point
----------------------------------------------------------------------------------------------------------------
                                     V12 Is Amended To Add Changeover Point
----------------------------------------------------------------------------------------------------------------
NEWCOMERSTOWN, OH VOR/DME...........  ALLEGHENY, PA VOR/DME..           30  NEWCOMERSTOWN.
----------------------------------------------------------------------------------------------------------------
                                   V495 Is Amended To Delete Changeover Point
----------------------------------------------------------------------------------------------------------------
SEATTLE, WA VORTAC..................  VICTORIA, CA VOR/DME...           50  SEATTLE.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2018-00130 Filed 1-8-18; 8:45 am]
BILLING CODE 4910-13-P


species. orig stage year impinged. est entrained. est junk junk  999  999  999 alewife age01 1975 2145500 NA smelt age01 1975 568474 NA trout age01 1975 635 NA salmon age01 1975 190 NA yellow. perch age01 1975 1747 NA suckers. spp age01 1975 468 NA forage age01 1975 37105 NA alewife larvae 1975 NA 1,054,409.19 smelt larvae 1975 NA 4,713,829.32 sculpin larvae 1975 NA 124,048.14 cyprinid larvae 1975 NA 241,204.72 longnose. dace larvae 1975 NA 34,457.82 unidentified larvae 1975 NA 34,457.82 alewife egg 1975 NA 9,095,742.60 smelt egg 1975 NA 74,250.96 sculpin egg 1975 NA 111,376.44 notes comments QC junk junk junk Data taken directly from the results of the Oak Creek Report June 1, 1976; assigned number 35661 Data taken directly from the results of the Oak Creek Report June 1, 1976; assigned number 35661 Data taken directly from the results of the Oak Creek Report June 1, 1976; assigned number 35661 Data taken directly from the results of the Oak Creek Report June 1, 1976; assigned number 35661 Data taken directly from the results of the Oak Creek Report June 1, 1976; assigned number 35661 see readme see readme Multiplying the percentage with the estimated total larvae entrainment( page III 9) Multiplying the percentage with the estimated total larvae entrainment( page III 9) Multiplying the percentage with the estimated total larvae entrainment( page III 9) Calculated by spliting the 5%( see calculations) and then Multiplying the percentage with the estimated total l Calculated by spliting the 5%( see calculations) and then Multiplying the percentage with the estimated total l Calculated by spliting the 5%( see calculations) and then Multiplying the percentage with the estimated total l Multiplying the percentage with the estimated total egg entrainment( page III 9) Calculated by spliting the 2%( see calculations) and then Multiplying the percentage with the estimated total e Calculated by spliting the 2%( see calculations) and then Multiplying the percentage with the estimated total e al larvae entrainment( page III 9) al larvae entrainment( page III 9) al larvae entrainment( page III 9)

al egg entrainment( page III 9) al egg entrainment( page III 9) Impingement and entrainment losses data for the Oak Creek Power Plant, on Lake Mischigen, near Mi For the project Intake Anton Miescher July 19 2005 The term " non. ris. forage" is used for the categorie " Forage Fishes" on page ( III 7) and goldfish from th The term " non. ris. rec. com" refers to white sucker, longnose sucker and carp from the categorie " Rough Alewife adults were assumed to be age1 Smelt yearling were assumed to be age1 Milwaukee ( Phase 2 facility) assigned number 35661 Intake the categorie " Rough Fishes" ugh Fishes", this can be found on page ( III 7). name. as. entered species. orig species. lh stage. as. enterestage year Alewife alewife alewife age 1 age01 1975 Smelt smelt rainbow. smelt age 1 age01 1975 Trout trout whitefish juvenile age01 1975 Salmon salmon salmon juvenile age01 1975 Yellow perch yellow. perch yellow. perch unknown age01 1975 suckers. spp suckers. spp sucker. spp unknown age01 1975 forage forage other. forage unknown age01 1975 alewife alewife alewife larvae larvae 1975 smelt smelt rainbow. smelt larvae larvae 1975 sculpin sculpin sculpin. spp larvae larvae 1975 Cyprinid cyprinid carp larvae larvae 1975 Longnose Dace longnose. dace bluntnose. minnow larvae larvae 1975 Unid. unidentified other. forage larvae larvae 1975 alewife alewife alewife eggs egg 1975 smelt smelt rainbow. smelt eggs egg 1975 sculpin sculpin sculpin. spp eggs egg 1975 Pontoporeia pontoporeia larvae larvae 1975 Mysis mysis larvae larvae 1975 impinged. est entrained. est notes comments 2145500 NA Data taken directly from the results of the Oak Creek Re 568474 NA Data taken directly from the results of the Oak Creek Re 635 NA Data taken directly from the results of the Oak Creek Re 190 NA Data taken directly from the results of the Oak Creek Re 1747 NA Data taken directly from the results of the Oak Creek Re 468 NA see readme 37105 NA see readme NA 1,054,409.19 Multiplying the percentage with the estimated total larva NA 4,713,829.32 Multiplying the percentage with the estimated total larva NA 124,048.14 Multiplying the percentage with the estimated total larva NA 241,204.72 Calculated by spliting the 5%( see calculations) and then NA 34,457.82 Calculated by spliting the 5%( see calculations) and then NA 34,457.82 Calculated by spliting the 5%( see calculations) and then NA 9,095,742.60 Multiplying the percentage with the estimated total egg e NA 74,250.96 Calculated by spliting the 2%( see calculations) and then NA 111,376.44 Calculated by spliting the 2%( see calculations) and then NA 12600000 Data taken directly from the results of the Oak Creek Re NA 3000000 Data taken directly from the results of the Oak Creek Re QC Report June 1, 1976; assigned number 35661 Report June 1, 1976; assigned number 35661 Report June 1, 1976; assigned number 35661 Report June 1, 1976; assigned number 35661 Report June 1, 1976; assigned number 35661 vae entrainment( page III 9) vae entrainment( page III 9) vae entrainment( page III 9) en Multiplying the percentage with the estimated total larvae entrainment( page III 9) en Multiplying the percentage with the estimated total larvae entrainment( page III 9) en Multiplying the percentage with the estimated total larvae entrainment( page III 9) g entrainment( page III 9) en Multiplying the percentage with the estimated total egg entrainment( page III 9) en Multiplying the percentage with the estimated total egg entrainment( page III 9) Report June 1, 1976; assigned number 35661 Report June 1, 1976; assigned number 35661 1975 IMPINGMENT name stage year impinged entrained Alewife age 1 1975 2145500 Smelt age 1 1975 568474 Trout juvenile 1975 635 Salmon juvenile 1975 190 Yellow perch unknown 1975 1747 suckers. spp unknown 1975 468 forage unknown 1975 37105 ENTRAINMENT name stage year impinged entrained alewife larvae 1975 1,054,409.19 smelt larvae 1975 4,713,829.32 sculpin larvae 1975 124,048.14 Cyprinid larvae 1975 241,204.72 Longnose Dace larvae 1975 34,457.82 Unid. larvae 1975 34,457.82 alewife eggs 1975 9,095,742.60 smelt eggs 1975 74,250.96 sculpin eggs 1975 111,376.44 Shrimp Pontoporeia larvae 1975 12600000 Mysis larvae 1975 3000000 larvae [%/ 100] total estimated spliting the 5% 0.17 6202407 data from Table ( II. 2) 0.76 6202407 sum 0.95 0.02 6202407 [ no./ 1000m3] 0.038889 6202407 2 Jul Cyprinid 7.78 0.005556 6202407 31 Aug Longnose Dace 1.59 0.005556 6202407 4 Sep Unid. 1.42 sum 1 eggs [%/ 100] total estimated spliting the 2% alewife 0.98 9281370 data from Table ( II. 2) smelt 0.008 9281370 sculpin 0.012 9281370 [ no./ 1000m3] 1 11 May smelt 3.37 27 May sculpin 5.89 Sampled Volume Sampled Volume[ m3] [ no./ day] [ no./ day] [%] 899.6 6.998888 7 0.777778 0.038889 627.9 0.998361 1 0.111111 0.005556 702.4 0.997408 1 0.111111 0.005556 sum 8.994657 9 1 0.05 Sampled Volume Sampled Volume[ m3] [ no./ day] [ no./ day] [%] 592.7 1.997399 2 0.4 0.008 509.1 2.998599 3 0.6 0.012 sum 4.995998 5 1 0.02


[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)]
[Rules and Regulations]
[Page 50007]
[FR Doc No: 2018-21620]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2018-0925]

Drawbridge Operation Regulation; Trent River, New Bern, NC

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the U.S. 70 (Alfred C. Cunningham)
Bridge across the Trent River, mile 0.0, at New Bern, NC. The deviation
is necessary to accommodate the free movement of pedestrians and
vehicles during the 2018 Mumfest celebration. This deviation allows the
bridge to remain in the closed-to-navigation position.

DATES: This deviation is effective from 9:30 a.m. on October 13, 2018,
to 6:30 p.m. on October 14, 2018.

ADDRESSES: The docket for this deviation, [USCG-2018-0925], is
available at http://www.regulations.gov. Type the docket number in the
``SEARCH'' box and click ``SEARCH''. Click on Open Docket Folder on the
line associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Mickey Sanders, Bridge
Administration Branch Fifth District, Coast Guard; telephone (757) 398-
6587, email [email protected].

SUPPLEMENTARY INFORMATION: The Event Director, Swiss Bear Inc., with
approval from the North Carolina Department of Transportation, who owns
and operates the U.S. 70 (Alfred C. Cunningham) Bridge, has requested a
temporary deviation from the current operating regulations to
accommodate the free movement of pedestrians and vehicles during the
2018 Mumfest. The bridge is a double bascule bridge and has a vertical
clearance in the closed position of 14 feet above mean high water.
    The current operating schedule is set out in 33 CFR 117.843(a).
Under this temporary deviation, the bridge will be maintained in the
closed-to-navigation position and open every two hours, on the hour,
from 9:30 a.m. to 7:30 p.m. on Saturday, October 13, 2018, and from
9:30 a.m. to 6:30 p.m. on Sunday, October 14, 2018. From 7:30 p.m. on
Saturday, October 13, 2018, to 9:30 a.m. on Sunday, October 14, 2018,
the drawbridge will open on signal.
    The Alfred C. Cunningham Bridge is used by a variety of vessels
including recreational vessels, tug and barge traffic, fishing vessels,
and small commercial vessels. The Coast Guard has carefully considered
the nature and volume of vessel traffic on the waterway in publishing
this temporary deviation.
    Vessels able to pass through the bridge in the closed position may
do so at anytime. The bridge will be able to open for emergencies and
there is no immediate alternate route for vessels unable to pass
through the bridge in the closed position. The Coast Guard will also
inform the users of the waterways through our Local and Broadcast
Notices to Mariners of the change in operating schedule for the bridge
so that vessel operators can arrange their transits to minimize any
impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: September 27, 2018.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2018-21620 Filed 10-3-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 39 (Tuesday, February 27, 2018)]
[Notices]
[Pages 8485-8487]
[FR Doc No: 2018-03961]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0663]

Tissue Agnostic Therapies in Oncology: Regulatory Considerations
for Orphan Drug Designation; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the following public workshop entitled ``Tissue Agnostic
Therapies in Oncology: Regulatory Considerations for Orphan Drug
Designation.'' The purpose of the public workshop is to discuss factors
FDA should consider when evaluating drugs for orphan designation that
treat a tissue agnostic disease or condition in oncology, and
additional factors related to orphan exclusivity FDA should consider
when approving a product with a tissue agnostic indication.

DATES: The public workshop will be held on May 9, 2018, from 9 a.m. to
5 p.m. The public workshop may be extended or may end early depending
on the level of public participation. Submit either electronic or
written comments on this public workshop by June 8, 2018. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002.
Entrance for the public workshop participants (non-FDA employees) is
through Building 1, where routine security check procedures will be
performed. For parking and security information, please refer to
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before June 8, 2018. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end of June 8, 2018. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are

solely responsible for ensuring that your comment does not include any
confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else's Social
Security number, or confidential business information, such as a
manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-0663 for ``Tissue Agnostic Therapies in Oncology: Regulatory
Considerations for Orphan Drug Designation; Public Workshop; Request
for Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Office of Orphan
Products Development, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5210, Silver Spring, MD 20933,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The combination of government incentives, scientific advances, and
the promise of commercial opportunity has fueled extraordinary
investment in orphan drugs. Since the Orphan Drug Act was first passed
in 1983, over 650 rare disease indications for drugs and biologics have
been developed and approved for marketing. In fact, rare disease drug
approvals have accounted for approximately 40 percent of the new
molecular entities and therapeutic biologic products in the Center for
Drug Evaluation and Research for the last several years.
    Not only have we seen tremendous growth in the development of
products for rare diseases, but the very landscape of rare disease
product development is changing, with an increase in the development of
targeted therapies, more interest in the development of biologics
(including gene therapies), and tremendous growth in the oncology
space. For example, in 2017 alone, FDA granted its first tissue
agnostic approval (pembrolizumab for patients with unresectable or
metastatic, microsatellite instability-high (MSI-H) or mismatch repair
deficient (dMMR) solid tumors) and first tissue agnostic orphan drug
designations (larotrectinib and entrectinib, each for the treatment of
solid tumors with NTRK-fusion proteins). FDA also approved the first
cell-based gene therapy, KYMRIAH, for use in treating a rare pediatric
cancer.
    As advancements in genomics and precision medicine continue, FDA
has been taking these new developments into account as it considers
what constitutes a ``disease or condition.'' For example, one question
that has already arisen in oncology is whether a disease should be
defined in a tissue/organ-specific or a tissue agnostic manner. Because
the continued development of targeted therapies for molecularly defined
groups has the potential to alter the landscape of orphan drug
development, FDA is holding the public workshop to obtain input on the
complex scientific and regulatory issues surrounding molecularly
targeted drugs and biologics in oncology and the appropriate
application of orphan drug incentives in that paradigm. This discussion
will inform how the Agency can incorporate the latest science and drug
development trends into the implementation of the Orphan Drug Act, all
while continuing to reflect the goals intended by Congress.

II. Topics for Discussion at the Public Workshop

    This public workshop will consist of both presentations and
interactive panel discussions. The presentations will provide
information to outline the goals of the workshop and help promote
interactive discussions. Following the presentations, there will be a
moderated discussion where speakers and additional panelists will be
asked to provide their individual perspectives. The presentations and
discussions will focus on several related topics. Topics will involve
discussion of and seek input on factors FDA should consider when
evaluating drugs for orphan designation that treat a tissue agnostic
disease or condition in oncology and additional factors related to
orphan exclusivity to consider when approving a product with a tissue
agnostic indication. A detailed agenda will be posted on the following
website in advance of the workshop: https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm592778.htm.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the
following website by April 25, 2018: https://

www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm592778.htm.
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by April 25, 2018, 5 p.m. Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation when their registration has been
received. If time and space permit, onsite registration on the day of
the public workshop will be provided beginning an hour prior to the
start of the meeting.
    If you need special accommodations due to a disability, please
contact Nicole Wolanski, at<PHONE_NUMBER>, or
[email protected] no later than April 25, 2018.
    An agenda for the workshop and any other background materials will
be made available 5 days before the workshop at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm592778.htm.
    Streaming Webcast of the Public Workshop: For those unable to
attend in person, FDA will provide a live webcast of the workshop. To
register for the streaming webcast of the public workshop, please visit
the following website by May 8, 2018: https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm592778.htm.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm592778.htm.

    Dated: February 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03961 Filed 2-26-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Notices]
[Pages 39573-39577]
[FR Doc No: 2017-17560]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. RD16-10-000, RD17-5-000 and IC17-6-000]

Commission Information Collection Activities (FERC-725E); Comment
Request; Revision

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

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

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on revisions to the information
collection, FERC-725E (Mandatory Reliability Standards for the Western
Electric Coordinating Council), in Docket Nos. RD16-10-000, RD17-5-000
and IC17-6-000 and submitting the information collection to the Office
of Management and Budget (OMB) for review. Any interested person may
file

comments directly with OMB and should address a copy of those comments
to the Commission as explained below. The Commission published Notices
in the Federal Register on April 6, 2017, in Docket No. RD16-10-000;
and May 9, 2017, in Docket Nos. RD17-5-000 and IC17-6-000, requesting
public comments. FERC received no comments in response to the Notices
and is indicating that in its submittal to the OMB.

DATES: Comments on the collection of information are due September 20,
2017.

ADDRESSES: Comments filed with OMB, identified by OMB Control No. 1902-
0246, should be sent via email to the Office of Information and
Regulatory Affairs<EMAIL_ADDRESS>Attention: Federal Energy
Regulatory Commission Desk Officer. The Desk Officer may also be
reached via telephone at<PHONE_NUMBER>.
    A copy of the comments should also be sent to the Commission, in
Docket Nos. RD17-5, RD16-10 and IC17-6, by either of the following
methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in Docket Nos. RD17-5, RD16-10, and IC17-6 or in viewing/
downloading comments and issuances in these dockets may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

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

SUPPLEMENTARY INFORMATION:
    Title: FERC-725E, Mandatory Reliability Standards for the Western
Electric Coordinating Council.
    OMB Control No.: 1902-0246.
    Type of Request: Revisions to the FERC-725E information collection
requirements, as discussed in Docket Nos. RD16-10, RD17-5 and IC17-6.
    Abstract: Docket No. RD16-10-000: On March 23, 2016 (and
supplemented on November 16, 2016), the North American Electric
Reliability Corporation (NERC) and Western Electricity Coordinating
Council (WECC) filed a joint petition to retire regional Reliability
Standard TOP-007-WECC-1a--System Operating Limits (``SOL''). The
purpose of the proposed retirement is to shift away from the path-
centric model and allow entities in the Western Interconnection to
align their operating practices with the framework established in the
continent-wide TOP/IRO Reliability Standards approved in Order No.
817,\1\ which, according to NERC and WECC, achieve the objective of
operating within acceptable pre- and post-contingency reliability
criteria (i.e., within SOLs and Interconnection Reliability Operating
Limits (``IROL''). On March 10, 2017, the Commission approved the
retirement of regional Reliability Standard TOP-007-WECC-1a.\2\
---------------------------------------------------------------------------

    \1\ The burdens related to Order No. 817 are included in FERC-
725Z (Mandatory Reliability Standards: IRO Reliability Standards,
OMB Control No. 1902-0276), and FERC-725A Mandatory Reliability
Standards for the Bulk-Power System, OMB Control No. 1902-0244).
    \2\ The Delegated Letter Order is posted in FERC's eLibrary at
https://elibrary.ferc.gov/idmws/common/opennat.asp?fileID=14515285.
---------------------------------------------------------------------------

    Docket Nos. RD17-5 and IC17-6: On March 10, 2017, NERC and WECC
filed a joint petition in Docket No. RD17-5-000 \3\ requesting
Commission approval of: (a) Regional Reliability Standard VAR-501-WECC-
3 (Power System Stabilizers), and (b) the retirement of then-existing
regional Reliability Standard VAR-501-WECC-2. The petition states:
``Regional Reliability Standard VAR-501-WECC-3 establishes the
performance criteria for power system stabilizers to help ensure the
Western Interconnection is operated in a coordinated manner under
normal and abnormal conditions.'' VAR-501-WECC-3 was approved by order
in Docket No. RD17-5-000 on April 28, 2017.
---------------------------------------------------------------------------

    \3\ The joint petition and exhibits are posted in the
Commission's eLibrary system in Docket No. RD17-5-000.
---------------------------------------------------------------------------

    FERC-725E, overall background: The information collected by the
FERC-725E is required to implement the statutory provisions of section
215 of the Federal Power Act (FPA) (16 U.S.C. 824o). Section 215 of the
FPA buttresses the Commission's efforts to strengthen the reliability
of the interstate grid through the grant of new authority by providing
for a system of mandatory Reliability Standards developed by the
Electric Reliability Organization (ERO). Reliability Standards that the
ERO proposes to the Commission may include Reliability Standards that
are proposed to the ERO by a Regional Entity.\4\ A Regional Entity is
an entity that has been approved by the Commission to enforce
Reliability Standards under delegated authority from the ERO.\5\ On
June 8, 2008, the Commission approved eight regional Reliability
Standards submitted by the ERO that were proposed by WECC.\6\
---------------------------------------------------------------------------

    \4\ 16 U.S.C. 824o(e)(4).
    \5\ 16 U.S.C. 824o(a)(7) and (e)(4).
    \6\ North American Electric Reliability Corp., 119 FERC ] 61,260
(2007).
---------------------------------------------------------------------------

    WECC promotes bulk electric system reliability in the Western
Interconnection. WECC is the Regional Entity responsible for compliance
monitoring and enforcement. In addition, WECC provides an environment
for the development of Reliability Standards and the coordination of
the operating and planning activities of its members as set forth in
the WECC Bylaws.
    There are several regional Reliability Standards in the WECC
region. These regional Reliability Standards generally require entities
to document compliance with substantive requirements, retain
documentation, and submit reports to WECC. The following standards will
be continuing without change.
     BAL-002-WECC-2a (Contingency Reserve) \7\ requires
balancing authorities and reserve sharing groups to document compliance
with the contingency reserve requirements described in the standard.
---------------------------------------------------------------------------

    \7\ BAL-002-WECC-2 is included in the OMB-approved inventory for
FERC-725E. On November 9, 2016, NERC and WECC submitted a joint
petition for approval of an interpretation of BAL-002-WECC-2, to be
designated BAL-002-WECC-2a. BAL-002-WECC-2a was approved by order in
Docket No. RD17-3-000 on January 24, 2017. The Order determined: The
proposed interpretation provides clarification regarding the types
of resources that may be used to satisfy Contingency Reserve
requirements in regional Reliability Standard BAL-002-WECC-2. BAL-
002-WECC-2a did not trigger the Paperwork Reduction Act and did not
affect the burden estimate. BAL-002-WECC-2a is being included in
this Notice and the Commission's submittal to OMB as part of the
FERC-725E.
---------------------------------------------------------------------------

     BAL-004-WECC-02 (Automatic Time Error Correction) requires
balancing authorities to document that time error corrections and
primary inadvertent interchange payback were conducted according to the
requirements in the standard.
     FAC-501-WECC-1 (Transmission Maintenance) requires
transmission owners with certain transmission paths to have a
transmission maintenance and inspection plan and to document
maintenance and inspection activities according to the plan.
     IRO-006-WECC-2 (Qualified Transfer Path Unscheduled Flow
(USF)

Relief) \8\ requires balancing authorities and reliability coordinators
to document actions taken to mitigate unscheduled flow.
---------------------------------------------------------------------------

    \8\ On December 20, 2013, NERC and WECC submitted a joint
petition for approval of IRO-006-WECC-2 and retirement of IRO-006-
WECC-1. IRO-006-WECC-2 was approved by order in Docket No. RD14-9-
000 on May 13, 2014. Because the reporting burden for IRO-006-WECC-2
did not increase for entities that operate within the Western
Interconnection, FERC submitted the order to OMB for information
only. The burden related to IRO-006-WECC-2 does not differ from the
burden of IRO-006-WECC-1, which is included in the OMB-approved
inventory. IRO-006-WECC-2 is being included in this Notice and the
Commission's submittal to OMB as part of FERC-725E.
---------------------------------------------------------------------------

     PRC-004-WECC-2 (Protection System and Remedial Action
Scheme Misoperation) \9\ requires transmission owners, generator owners
and transmission operators to document their analysis and/or mitigation
due to certain misoperations on major transfer paths. This standard
requires that documentation be kept for six years.
---------------------------------------------------------------------------

    \9\ Order No. 818, issued on November 19, 2015 in Docket Nos.
RM15-7, RM15-12, and RM15-13, stated in part: ``NERC requested
approval of the following Reliability Standards to incorporate the
proposed definition of Remedial Action Scheme and eliminate use of
the term Special Protection System: . . . PRC-004-WECC-2, . . . NERC
did not propose any changes to the Violation Risk Factors or
Violation Severity Levels for the modified standards.'' Revisions to
Emergency Operations Reliability Standards; Revisions to
Undervoltage Load Shedding Reliability Standards; Revisions to the
Definition of ``Remedial Action Scheme'' and Related Reliability
Standards, Order No. 818, 153 FERC 61,228, at P 23 n.31 (2015). In
addition, Order No. 818 stated: The Commission approved the
definition of Special Protection System (Remedial Action Scheme) in
Order No. 693. We approve a revision to the previously approved
definition. The revisions to the Remedial Action Scheme definition
and related Reliability Standards are not expected to result in
changes to the scope of systems covered by the Reliability Standards
and other Reliability Standards that include the term Remedial
Action Scheme. Therefore, the Commission does not expect the
revisions to affect applicable entities' current reporting burden.
Id. P 67. The change to the definition did not affect the burden of
PRC-004-WECC-1 (which is included in the current OMB-approved
inventory). PRC-004-WECC-2 (the current version of the standard) is
being included in this Notice and the Commission's submittal to OMB
as part of the FERC-725E.
---------------------------------------------------------------------------

     VAR-002-WECC-2 (Automatic Voltage Regulators (AVR)) \10\
requires generator operators and transmission operators to provide
quarterly reports to the compliance monitor and have evidence related
to their synchronous generators, synchronous condensers, and automatic
voltage regulators.
---------------------------------------------------------------------------

    \10\ VAR-002-WECC-2 was approved by order in Docket No. RD15-1
on March 3, 2015. Regional Reliability Standard VAR-002-WECC-2 made
a non-material or non-substantive change to the reporting and
recordkeeping requirements associated with VAR-002-WECC-1 (currently
included in the OMB-approved inventory). VAR-002-WECC-2 (the current
version of the standard) is being included in this Notice and the
Commission's submittal to OMB as part of FERC-725E.
---------------------------------------------------------------------------

    The Commission will be submitting a request to OMB to extend those
requirements with no change for three years. The Commission's request
to OMB will also reflect the following:
     eliminating the burden associated with regional
Reliability Standard TOP-007-WECC-1a, which is being retired (addressed
in Docket No. RD16-10); \11\ and
---------------------------------------------------------------------------

    \11\ The Commission approved the retirement of regional
Reliability Standard TOP-007-WECC-1a (System Operating Limits
(``SOL'')) by order in Docket No. RD16-10-000 on March 10, 2017. On
March 31, 2017, the Commission issued a 60-day Notice requesting
public comment on the effect on burden. The 60-day Notice is
available at 82 FR 16823 (April 6, 2017). Comments on the 60-day
Notice were due in Docket No. RD16-10-000 by June 5, 2017; no
comments were received. See Docket No. RD16-10-000 for additional
information (including the estimated annual burden reduction of
1,188 hours).
---------------------------------------------------------------------------

     implementing the regional Reliability Standard VAR-501-
WECC-3 and retiring regional Reliability Standard VAR-501-WECC-2
(addressed in Docket No. RD17-5 and discussed below).
    In this document, we provide estimates of the burden and cost
related to those revisions to FERC-725E. Details follow on the changes
due to Docket Nos. RD16-10, RD17-5-000, and IC17-6 and on the
continuing burdens which are being submitted to OMB for approval in a
consolidated package under FERC-725E.
    Type of Respondents: Balancing authorities, reserve sharing groups,
transmission owners, reliability coordinators, transmission operators,
generator operators and generator owners.
    Estimate of Annual Burden: \12\ We provide three tables below with
burden estimates which show: (1) Reductions due to Docket No. RD16-10,
(2) reductions, increases, and net changes, due to Docket No. RD17-5,
and (3) resulting net ongoing burden for FERC-725E overall, which will
be submitted to OMB for approval.
---------------------------------------------------------------------------

    \12\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, refer to 5 Code of Federal Regulations 1320.3.
---------------------------------------------------------------------------

    Changes Due to Docket No. RD16-10. The Commission estimates the
reduction in the annual public reporting burden for the FERC-725E (due
to the retirement of regional Reliability Standard TOP-007-WECC-1a) as
follows: \13\
---------------------------------------------------------------------------

    \13\ The reductions in burden and cost shown in the table are
the same figures as those in the current OMB-approved inventory for
the reporting and recordkeeping requirements, now being retired.
    \14\ This is based on burden estimates taken from the Order in
Docket No. RR07-11-000, P. 130.

             FERC-725E, Mandatory Reliability Standards for the Western Electric Coordinating Council, Reductions Due to Docket No. RD16-10
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Annual
                                                    number of
 Information collection requirements   Number of    responses    Total number   Average burden hours and cost per   Total annual burden hours and total
             and entity               respondents      per       of responses                response                           annual cost
                                                    respondent
                                              (1)          (2)   (1) x (2)=(3)  (4)..............................  (3) x (4)=(5)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting Requirement--Transmission             9            3              27  40 hrs.; $2,908..................  1,080 hrs.; $78,516
 Operators that operate qualified
 transfer paths \14\.
Recordkeeping Requirement--                     9            1               9  12 hrs.; $347....................  108 hrs.; $3,124.
 Transmission Operators that operate
 qualified transfer paths.
    Total Reduction (Due to Docket    ...........  ...........  ..............  .................................  1,188 hrs.; $81,640.
     No. RD16-10).
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimate of Annual Burden: \15\ Details follow on the changes in
Docket No. RD17-5-000, and on the continuing burdens, which will be
submitted to OMB for approval in a consolidated package under FERC-
725E.
---------------------------------------------------------------------------

    \15\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, refer to 5 Code of Federal Regulations 1320.3.
    \16\ The number of respondents is derived from the NERC
Compliance Registry as of March 10, 2017.
    \17\ For VAR-501-WECC-3, the hourly cost (for salary plus
benefits) uses the figures from the Bureau of Labor Statistics for
three positions involved in the reporting and recordkeeping
requirements. These figures include salary (http://bls.gov/oes/current/naics2_22.htm) and benefits (http://www.bls.gov/news.release/ecec.nr0.htm) and are: 1. Manager: $89.07/hour; 2.
Engineer: $64.91/hour; 3. File Clerk: $31.19/hour. The hourly cost
for the reporting requirements ($76.99) is an average of the cost of
a manager and engineer. The hourly cost for recordkeeping
requirements uses the cost of a file clerk.

                                   FERC-725E, Mandatory Reliability Standards for the Western Electric Coordinating Council, Changes in Docket No. RD17-5-000
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Annual  number
                                        Number of     of  responses  Annual  number   Average  burden hours and  cost    Total annual burden hours and total
               Entity                  respondents         per        of  responses        \17\ per response ($)                   annual cost ($)                  Cost per respondent ($)
                                          \16\         respondent
                                                (1)             (2)     (1) x (2) =  (4)..............................  (3) x (4) = (5)......................  (5) / (1) = (6)
                                                                                (3)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Retirement of Former Standard VAR-501-WECC-2 and Associated Reductions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Reporting Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Generator Operators................             249               4             996  1 hr.; $76.22....................  996 hrs.; $75,915.12 (reduction).....  $304.88 (reduction)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Recordkeeping Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Generator Operators................             249               4             996  0.5 hrs.; $31.19.................  498 hrs.; $15,532.62 (reduction).....  $62.38 (reduction)
Reductions (Discontinued in yr. 1).  ..............  ..............  ..............  .................................  1,494 hrs.; $91,447.74 (reduction)...
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                New Standard VAR-501-WECC-3
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Reporting Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Generator Owners and/or Operators,              291               3             873  1 hr.; $76.99....................  873 hrs.; $67,212.27.................  $230.97
 in Year 1.
Generator Owners and/or Operators,              291               2             582  1 hr.; $76.99....................  582 hrs.; $44,808.18.................  $153.98
 in Year 2 and Ongoing.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Recordkeeping Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Generator Owners and/or Operators,              291               3             873  1 hr.; $31.19....................  873 hrs.; $27,228.87.................  $93.57
 in Year 1.
Generator Owners and/or Operators,              291               2             582  0.5 hrs.; $15.595................  291 hrs.; $9,076.29..................  $31.19
 in Year 2 and Ongoing.
New Burden, in Year 1..............  ..............  ..............  ..............  .................................  1,746 hrs.; $94,441.14...............
New Burden, in Year 2 & Ongoing....  ..............  ..............  ..............  .................................  873 hrs.; $53,884.47.................
Net Burden Change in Year 1 (Due to  ..............  ..............  ..............  .................................  +252 hrs. (increase).................
 Docket RD17-5).
Net Burden Change in Year 2 and      ..............  ..............  ..............  .................................  -621 hrs. (decrease).................
 Ongoing (Due to Docket RD17-5).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Net Burden for FERC-725E, for Submittal to OMB. The table below
describes the new and continuing information collection requirements
and the associated burden for FERC-725E. (The burdens and costs related
to TOP-007-WECC-1a and VAR-501-WECC-2 [the standards being retired] are
omitted.)

                                FERC-725E, Mandatory Reliability Standards for the Western Electric Coordinating Council
                                                [New and continuing information collection requirements]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   Annual number                    Average burden hours
            Entity                  Number of      of responses    Annual number   and cost per response   Total annual burden hours and     Cost per
                                respondents \18\  per respondent   of responses             ($)                total annual cost ($)      respondent ($)
                                             (1)             (2)     (1) * (2) =  (4)....................  (3) * (4) = (5)..............     (5) / (1) =
                                                                             (3)                                                                     (6)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Reporting Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Balancing Authorities.........                34               1              34  21 hrs., $1,616.79.....  714 hrs., $54,970.86.........       $1,616.79
Generator Operators...........               228               1             228  10 hrs., $769.90.......  2,280 hrs., $175,537.20......          769.90

Transmission Operators                        86               4             344  10 hrs., $769.90.......  3,440 hrs., $264,845.60......          769.90
 applicable to standard VAR-
 002.
Transmission Owners that                       5               3              15  40 hrs., $3,079.60.....  600 hrs., $46,194.00.........        3,079.60
 operate qualified transfer
 paths.
Reliability Coordinators......                 1               1               1  1 hr., $76.99..........  1 hr., $76.99................           76.99
Reserve Sharing Group.........                 3               1               3  1 hr., $76.99..........  3 hrs., $230.97..............           76.99
Generator Owners and/or                      291               3             873  1 hr.; $76.99..........  873 hrs.; $67,212.27.........          230.97
 Operators , in Year 1, per
 RD17-5 for VAR-501-WECC-3.
Generator Owners and/or                      291               2             582  1 hr.; $76.99..........  582 hrs.; $44,808.18.........          153.98
 Operators, in Year 2 and
 Ongoing, per RD17-5 for VAR-
 501-WECC-3.
                               -------------------------------------------------------------------------------------------------------------------------
    Total for Reporting         ................  ..............  ..............  .......................  7,911 hrs.; $609,067.89......  ..............
     Requirements in Year 1.
                               -------------------------------------------------------------------------------------------------------------------------
    Total for Reporting         ................  ..............  ..............  .......................  7,620 hrs.; $586,663.80......  ..............
     Requirements in Year 2 &
     ongoing.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Recordkeeping Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Balancing Authorities.........                34               1              34  2.1 hrs., $65.50.......  71.4 hrs., $2,226.97.........           65.50
Balancing Authorities (IRO-                   34               1              34  1 hr., $31.19..........  34 hrs., $1,060.46...........           31.19
 006).
Generator Operators...........               228               1             228  1 hr., $31.19..........  228 hrs., $7,111.32..........           31.19
Transmission Operator (VAR-                   86               1              86  4 hrs., $124.76........  344 hrs., $10,729.36.........          124.76
 002).
Transmission Owner that                        5               1               5  12 hrs., $374.28.......  60 hrs., $1,871.40...........          374.28
 operate qualified transfer
 paths.
Reliability Coordinator.......                 1               1               1  1 hr.; $31.19..........  1 hr.; $31.19................           31.19
Generator Owners and/or                      291               3             873  1 hr.; $31.19..........  873 hrs.; $27,228.87.........           93.57
 Operators, in Year 1, per
 RD17-5 for VAR-501-WECC-3.
Generator Owners and/or                      291               2             582  0.5 hrs.; $15.595......  291 hrs.; $9,076.29..........           31.19
 Operators, in Year 2 and
 Ongoing, per RD17-5 for VAR-
 501-WECC-3.
                               -------------------------------------------------------------------------------------------------------------------------
    Total for Recordkeeping     ................  ..............  ..............  .......................  1,611.4 hrs.; $50,259.57.....  ..............
     Requirements in Yr. 1.
                               -------------------------------------------------------------------------------------------------------------------------
    Total for Recordkeeping     ................  ..............  ..............  .......................  1,029.4 hrs.; $32,106.99.....  ..............
     Requirements in Yr. 2 &
     ongoing.
                               -------------------------------------------------------------------------------------------------------------------------
    Total for FERC-725E, IN     ................  ..............  ..............  .......................  9,522.4 hrs.; $659,327.46....  ..............
     YR. 1.
                               -------------------------------------------------------------------------------------------------------------------------
    Total for FERC-725E, in     ................  ..............  ..............  .......................  8,649.4 hrs.; $618,770.79....  ..............
     yr. 2 & ongoing.
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\18\ The number of respondents is derived from the NERC Compliance Registry as of March 10, 2017.

    Comments: Comments are invited on: (1) Whether the 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 and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: August 15, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-17560 Filed 8-18-17; 8:45 am]
BILLING CODE 6717-01-P