[Federal Register Volume 80, Number 140 (Wednesday, July 22, 2015)]
[Notices]
[Page 43422]
[FR Doc No: 2015-17948]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that members of the Commission's staff may attend the following
meeting related to the transmission planning activities of the
Midcontinent Independent System Operator, Inc. (MISO):

MISO Planning Advisory Committee
July 29, 2015, 9 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be held at: MISO Headquarters,
720 City Center Drive, Carmel, IN 46032.
    Further information may be found at www.misoenergy.org.
    The discussions at the meeting described above may address matters
at issue in the following proceedings:

Docket Nos. ER13-1944, et al., PJM Interconnection, LLC
Docket No. ER14-1174, Southwest Power Pool, Inc.
Docket No. ER14-1736, Midcontinent Independent System Operator, Inc.
Docket No. ER14-2445, Midcontinent Independent System Operator, Inc.
Docket No. ER13-1864, Southwest Power Pool, Inc.
Docket No. EL14-21, Southwest Power Pool, Inc. v. Midcontinent
Independent System Operator, Inc.
Docket No. EL14-30, Midcontinent Independent System Operator, Inc. v.
Southwest Power Pool, Inc.
Docket No. EL11-34, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER11-1844, Midwest Independent Transmission System Operator,
Inc.
Docket No. EL13-88, Northern Indiana Public Service Company v.
Midcontinent Independent System Operator, Inc. and PJM Interconnection,
L.L.C.
Docket Nos. ER13-1923, et al., Midcontinent Independent System
Operator, Inc.
Docket Nos. ER13-1937, et al., Southwest Power Pool, Inc.

    For more information, contact Chris Miller, Office of Energy Market
Regulation, Federal Energy Regulatory Commission at<PHONE_NUMBER> or
<EMAIL_ADDRESS>or Jason Strong, Office of Energy Market
Regulation, Federal Energy Regulatory Commission at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
    Dated: July 16, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-17948 Filed 7-21-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 6, 2007 (Volume 72, Number 108)]
[Notices]
[Page 31312-31314]
[DOCID:fr06jn07-76]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  1

May 30, 2007.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC06-15-001; EC06-78-001; EC07-37-001; EC06-147-
001.
    Applicants: Entegra Power Group LLC; Gila River Power, L.P.; Union
Power Partners, L.P.; Morgan Stanley & Co. Incorporated; Merrill Lynch;
Pierce, Fenner & Smith Inc.; Entegra Holdings LLC; Entegra TC LLC.
    Description: Application by Entegra Power Group, LLC et al for
order amending blanket authorizations for certain future transfers &
acquisitions of equity interests under Section 203.
    Filed Date: 5/15/2007.
    Accession Number: 20070524-0006.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 5, 2007.

    Docket Numbers: EC07-94-000.
    Applicants: Forked River Power LLC.
    Description: Forked River Power LLC submits an application for its
proposed acquisition of the Forked River Generating Station with
related assets and real property from Jersey Central Power & Light Co.
    Filed Date: 5/21/2007.
    Accession Number: 20070524-0116.
    Comment Date: 5 p.m. Eastern Time on Monday, June 11, 2007.

    Docket Numbers: EC07-95-000.
    Applicants: UBS Americas Inc.; UBS International Infrastructure
Fund; UBS AG; Northern Star Generation LLC; AIG Global Investment
Corp.; Front Range Power Company, LLC; Vandolah Power Company, LLC.
    Description: UBS Americas Inc et al submit a Joint Application for
authorization for disposition of jurisdictional assets pursuant to
section 203 of the FPA.
    Filed Date: 5/21/2007.
    Accession Number: 20070524-0087.
    Comment Date: 5 p.m. Eastern Time on Monday, June 11, 2007.

    Docket Numbers: EC07-96-000.
    Applicants: Eagle Energy Partners I, LP; Lehman Brothers Commodity
Services Inc.
    Description: Eagle Energy Partners I, LP et al submit an
application under Section 203 for authorization of disposition of
jurisdictional facilities resulting from Lehman's proposed acquisition
of all ownership interest in Eagle.
    Filed Date: 5/21/2007.
    Accession Number: 20070524-0181.
    Comment Date: 5 p.m. Eastern Time on Monday, June 11, 2007.

    Docket Numbers: EC07-97-000.
    Applicants: Ecofin Holdings Limited; Ecofin Limited; Ecofin, Inc.;
Ecofin Fund Management Limited; Ecofin General Partner Limited; Ecofin
Water & Power Opportunities Plc; Ecofin Global Utilities Hedge Fund
Limit; Ecofin Global Utilities Hedge Fund LP; Ecofin Global Utilities
Master Fund Limited; Ecofin Special Situations Utilities Fund; Ecofin
Special Situations Utilities Fund; Ecofin Special Situations Utilities
Master; HFR HE Ecofin Master Trust.
    Description: Ecofin Holdings Limited et al submit its request for
blanket authorization to acquire securities under Section 203 of the
FPA.
    Filed Date: 5/24/2007.
    Accession Number: 20070529-0241.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 14, 2007.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG07-56-000.
    Applicants: Tiverton Power LLC and Rumford Power LLC.
    Description: Tiverton Power LLC and Rumford Power LLC notice of
Self-Certification of Exempt Wholesale Generator Status as the Proposed
Owners of the Tiverton and Rumford Generating Facilities.
    Filed Date: 5/24/2007.
    Accession Number: 20070524-5068.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 14, 2007.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER99-1761-002.
    Applicants: AES Eastern Energy, LP.
    Description: AES Eastern Energy, LP submits a notice of Non-
Material Change in Status Regarding Market-Based Rate Authority.
    Filed Date: 5/24/2007.
    Accession Number: 20070524-5010.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 14, 2007.

    Docket Numbers: ER01-1266-008; ER01-1270-010; ER01-1267-010; ER01-
1278-010; ER01-1268-009; ER01-1271-009; ER01-1272-008; ER01-1269-008;
ER01-1273-009; ER01-1277-008; ER02-1213-007; ER06-406-001.
    Applicants: Mirant California, LLC; Mirant Delta, LLC; Mirant
Canal, LLC; Mirant Kendall, LLC; Mirant Potrero, LLC; Mirant Bowline,
LLC; Mirant Lovett, LLC; Mirant Chalk Point, LLC; Mirant Mid-Atlantic,
LLC; Mirant Potomac River, LLC; Mirant Energy Trading, LLC; Mirant
Power Purchase, LLC.
    Description: Mirant Entities submits Notice of a Non-Material
Change in Status to reflect certain departures from the facts the
Commission relied upon in granting market-based rate authority.
    Filed Date: 5/22/2007.
    Accession Number: 20070524-0120.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 12, 2007.

    Docket Numbers: ER05-1178-010; ER05-1191-010.
    Applicants: Gila River Power, L.P.; Union Power Partners, L.P.
    Description: Gila River Power, L.P. et al submits notice of non-
material change in status relating to their upstream ownership
structure.
    Filed Date: 5/24/2007.
    Accession Number: 20070529-0244.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 14, 2007.

    Docket Numbers: ER06-456-011; ER06-954-007; ER06-1271-006; ER07-
424-002.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, LLC submits amendments to
Schedule 12--Appendix to reflect the allocation of cost responsibility
on a region-wide basis etc, in compliance with FERC's 4/19/07 Order.
    Filed Date: 5/21/2007.
    Accession Number: 20070524-0038.
    Comment Date: 5 p.m. Eastern Time on Monday, June 11, 2007.

    Docket Numbers: ER07-335-001; ER07-335-000.
    Applicants: E.ON U.S., LLC.

    Description: E.ON U.S., LLC submits a motion to withdraw Service
Agreement Filing.
    Filed Date: 5/16/2007.
    Accession Number: 20070516-5085.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 6, 2007.

    Docket Numbers: ER07-569-001.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corp submits
its Compliance Filing re Load Scheduling Amendment to the ISO Tariff in
accordance with FERC's April 24, 2007 Order.
    Filed Date: 5/23/2007.
    Accession Number: 20070525-0074.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 13, 2007.

    Docket Numbers: ER07-577-002.
    Applicants: The Midwest Independent Transmission System Operator,
Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits supplemental information pursuant to FERC's 4/20/07 Deficiency
Letter.
    Filed Date: 5/22/2007.
    Accession Number: 20070524-0119.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 12, 2007.

    Docket Numbers: ER07-577-003.
    Applicants: Midwest Independent Transmission System.
    Description: Endeavor Power Partners, LLC submits responses to
FERC's Data Requests, 4/20/06 deficiency letter.
    Filed Date: 5/21/2007.
    Accession Number: 20070524-0118.
    Comment Date: 5 p.m. Eastern Time on Monday, June 11, 2007.

    Docket Numbers: ER07-613-001.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corp submits
its Compliance Filing in accordance with FERC's May 8 Order.
    Filed Date: 5/23/2007.
    Accession Number: 20070525-0076.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 13, 2007.

    Docket Numbers: ER07-876-001.
    Applicants: Chevron Coalinga Energy Company; Texaco Natural Gas
Inc.
    Description: Chevron Coalinga Energy Co submits an amendment to the
5/9/07 filing of a notice succession and tariff filing to renumber and
re-date the redline and clean tariff sheets.
    Filed Date: 5/23/2007.
    Accession Number: 20070525-0077.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 13, 2007.

    Docket Numbers: ER07-877-001.
    Applicants: WSPP Inc.
    Description: Grays Harbor Energy LLC requests that FERC accept an
amendment to WSPP, Inc's Agreement to include them as a participant.
    Filed Date: 5/23/2007.
    Accession Number: 20070525-0075.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 13, 2007.

    Docket Numbers: ER07-919-000.
    Applicants: Mint Farm Energy Center LLC.
    Description: Mint Farm Energy Center LLC submits an application for
Market-Based Rate Authority and Associated Waivers and Blanket
Approvals.
    Filed Date: 5/21/2007.
    Accession Number: 20070524-0059.
    Comment Date: 5 p.m. Eastern Time on Monday, June 11, 2007.

    Docket Numbers: ER07-920-000.
    Applicants: Entergy Services, Inc.
    Description: Entergy Services, Inc agent for Entergy Operating
Companies submits an executed Second Revised Network Integration
Transmission Service Agreement etc with the City of Ruston, Louisiana.
    Filed Date: 5/22/2007.
    Accession Number: 20070524-0081.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 12, 2007.

    Docket Numbers: ER07-923-000.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corp submits an
executed Metered Subsystem Agreement with the City of Riverside, CA and
a notice of termination for Service Agreements 424 and 636.
    Filed Date: 5/18/2007.
    Accession Number: 20070524-0061.
    Comment Date: 5 p.m. Eastern Time on Friday, June 8, 2007.

    Docket Numbers: ER07-930-000.
    Applicants: AER NY-Gen, LLC.
    Description: AER NY-Gen, LLC submits a revised Market-Based Rate
Tariff to reflect a name change etc.
    Filed Date: 5/23/2007.
    Accession Number: 20070525-0067.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 13, 2007.

    Docket Numbers: ER07-931-000.
    Applicants: Oncor Electric Delivery Company.
    Description: Oncor Electric Delivery Co submits First Revised Sheet
37 et al to FERC Electric Tariff, Tenth Revised Volume 1 to be
effective 4/26/07.
    Filed Date: 5/24/2007.
    Accession Number: 20070525-0066.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 14, 2007.

    Docket Numbers: ER07-932-000.
    Applicants: Oncor Electric Delivery Company.
    Description: Oncor Electric Delivery Co submits First Revised Sheet
34 to FERC Electric Tariff, Fifth Revised Volume 2 to be effective 4/
26/07.
    Filed Date: 5/24/2007.
    Accession Number: 20070525-0065.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 14, 2007.

    Docket Numbers: ER07-933-000.
    Applicants: Nevada Power Company.
    Description: Nevada Power Co submits three Notices of Cancellation
of FERC Rate Schedule 91, 94 and 95.
    Filed Date: 5/24/2007.
    Accession Number: 20070525-0064.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 14, 2007.

    Docket Numbers: ER07-934-000.
    Applicants: The Detroit Edison Company.
    Description: The Detroit Edison Co submits Second Revised Sheet 23
et al to FERC Electric Tariff, First Revised Volume 5 to be effective
6/1/07.
    Filed Date: 5/24/2007.
    Accession Number: 20070525-0063.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 14, 2007.

    Docket Numbers: ER07-935-000.
    Applicants: Entergy Services, Inc.
    Description: Entergy Services Inc proposes to amend its Available
Flowgate Capacity Process Manual to implement a new process for
determining generation dispatch levels in power flow models used to
calculate AFC values.
    Filed Date: 5/24/2007.
    Accession Number: 20070529-0246.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 14, 2007.

    Docket Numbers: ER07-936-000; ER07-958-000.
    Applicants: Tiverton Power LLC and Rumford Power LLC.
    Description: Tiverton Power, LLC and Rumford Power, LLC submits
their application requesting authorization to sell power at market-
based rates.
    Filed Date: 5/24/2007.
    Accession Number: 20070529-0245.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 14, 2007.

    Docket Numbers: ER07-937-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits the Transmission Interconnection
Agreement dated 5/18/07 with Flowell Electric Association.
    Filed Date: 5/24/2007.
    Accession Number: 20070529-0240.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 14, 2007.

    Docket Numbers: ER07-939-000.
    Applicants: Columbia Utilities Power, LLC.
    Description: Columbia Utilities Power, LLC submits a Petition for

Acceptance of Initial Tariff, Waivers and Blanket Authority, FERC
Electric Tariff, Original Volume 1.
    Filed Date: 5/25/2007.
    Accession Number: 20070530-0121.
    Comment Date: 5 p.m. Eastern Time on Friday, June 15, 2007.

    Docket Numbers: ER07-940-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.;
PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC and Midwest Independent
System Operator, Inc submits their revised Congestion Management
Process of their Joint Operating Agreement and request waiver of FERC's
notice requirements etc.
    Filed Date: 5/25/2007.
    Accession Number: 20070530-0120.
    Comment Date: 5 p.m. Eastern Time on Friday, June 8, 2007.

    Docket Numbers: ER07-941-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits notice of
termination of the revised Service Agreement for Wholesale Distribution
Service and Letter Agreement with Modesto Irrigation District.
    Filed Date: 5/25/2007.
    Accession Number: 20070530-0135.
    Comment Date: 5 p.m. Eastern Time on Friday, June 15, 2007.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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 dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-10819 Filed 6-5-07; 8:45 am]

BILLING CODE 6717-01-P


February 5, 2002 Donald R. Lynam Vice President, Air Conservation Ethyl Corporation 330 South Fourth Street Richmond, VA 23219 4304 Dear Dr. Lynam,

On January 22, 2002, you submitted a request to Joseph Sopata of my staff for a four month extension for the submission of the audited, peer reviewed draft final report for the health study entitled, " Pharmacokinetics of inhaled manganese sulfate in pregnant and lactating CD rats", ( CIIT ( Chemical Industry Institute of Toxicology) Protocol 01003), as required under the MMT Alternative Tier 2 Health Effects Testing Requirements. This protocol was approved by the Agency on October 26, 2001.

According to Schedule D. 2 in the MMT Alternative Tier 2 Health Effects Testing Requirements, the audited, peer reviewed draft final report for the health study entitled, " Pharmacokinetics of inhaled manganese sulfate in pregnant and lactating CD rats", ( CIIT Protocol 01003), is due on November 1, 2002. In an attachment to your request for an extension, Dr. David Dorman of CIIT indicated that the in life phase of this study could end as late as May 8, 2002. He also indicated that the original schedule provides CIIT with less than 6 months to complete the last set of tissue analyses and submit an audited, peer reviewed, draft final report to the Agency. Because he thought more time was needed, Dr. Dorman asked you to submit a request for an extension of 3 to 4 months to the original schedule. You indicated that Ethyl agrees with Dr. Dorman's concerns. Finally, you indicated in your request that this extension would not affect the scheduled beginning of the primate study, which requires that a draft peer reviewed protocol be submitted to the Agency by April 1, 2002.

We believe your request for an extension is reasonable. This letter conveys the Agency's approval for a 4 month extension, until March 1, 2003, to schedule D. 2 for the submission of the audited, peer reviewed draft final report for the health study entitled, " Pharmacokinetics of inhaled manganese sulfate in pregnant and lactating CD rats", ( CIIT Protocol 01003). This extension would also be applied to schedule D. 2 for the Agency's submission of comments on this draft final report as well as Ethyl's submission of the final report to EPA.  2

If you have any questions concerning extension in the schedule, please contact Joe Sopata of my staff at ( 202) 564 9034.

Sincerely,

/ s/

Robert E. Larson, Acting Director Transportation and Regional Programs Division cc: Monica Alvarez, ORD/ OSP Tim Backstrom, OGC Kevin Fast, Hunton & Williams


[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)]
[Notices]
[Pages 8089-8090]
[FR Doc No: 2018-03700]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0478]

Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 24 abbreviated

new drug applications (ANDAs) from multiple applicants. The holders of
the applications notified the Agency in writing that the drug products
were no longer marketed and requested that the approval of the
applications be withdrawn.

DATES: Approval is withdrawn as of March 26, 2018.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: The holders of the applications listed in
the table have informed FDA that these drug products are no longer
marketed and have requested that FDA withdraw approval of the
applications under the process in Sec.  314.150(c) (21 CFR 314.150(c)).
The applicants have also, by their requests, waived their opportunity
for a hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
ANDA 040398............  MiCort-HC                Sebela Ireland, Ltd.,
                          (hydrocortisone          c/o Sebela
                          acetate) Cream USP, 2%.  Pharmaceuticals,
                                                   Inc., 645 Hembree
                                                   Parkway, Suite 1,
                                                   Roswell, GA 30076.
ANDA 071893............  Acetohexamide Tablets,   Watson Laboratories,
                          250 milligrams (mg).     Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
ANDA 071894............  Acetohexamide Tablets,    Do.
                          500 mg.
ANDA 073143............  Cyclobenzaprine           Do.
                          Hydrochloride (HCl)
                          Tablets USP, 10 mg.
ANDA 074576............  Captopril Tablets USP,    Do.
                          12.5 mg, 25 mg, 50 mg,
                          and 100 mg.
ANDA 076607............  Quinapril Tablets USP,   Sun Pharmaceutical
                          Equivalent to (EQ) 5     Industries, Ltd., c/o
                          mg base, EQ 10 mg        Sun Pharmaceutical
                          base, EQ 20 mg base,     Industries, Inc., 2
                          and EQ 40 mg base.       Independence Way,
                                                   Princeton, NJ 08540.
ANDA 076786............  Donepezil HCl Tablets     Do.
                          USP, 5 mg and 10 mg.
ANDA 077483............  Benazepril HCl and        Do.
                          Hydrochlorothiazide
                          Tablets, 5 mg/6.25 mg,
                          10 mg/12.5 mg, 20 mg/
                          12.5 mg, and 20 mg/25
                          mg.
ANDA 078502............  Eliphos (calcium         Cypress
                          acetate) Tablets USP,    Pharmaceutical, Inc.,
                          667 mg.                  10 North Park Pl.,
                                                   Suite 201,
                                                   Morristown, NJ 07960.
ANDA 081019............  Chlorzoxazone Tablets    Watson Laboratories,
                          USP, 500 mg.             Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 083821............  Brompheniramine Maleate   Do.
                          Injection, 10 mg/
                          milliliter (mL).
ANDA 084408............  Bethanechol Chloride      Do.
                          Tablets USP, 10 mg.
ANDA 084441............  Bethanechol Chloride      Do.
                          Tablets USP, 25 mg.
ANDA 085283............  Theolair (theophylline)  3M Drug Delivery
                          Tablets, 125 mg and      Systems, 3M Center,
                          250 mg.                  Bldg. 275-3E-02, 2510
                                                   Conway Ave., St.
                                                   Paul, MN 55144.
ANDA 085738............  Betamethasone Sodium     Watson Laboratories,
                          Phosphate Injection,     Inc., Subsidiary of
                          EQ 3 mg base/mL.         Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 087444............  Bethanechol Chloride     Watson Laboratories,
                          Tablets USP, 50 mg.      Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 087792............  Fluorouracil Injection   Spectrum
                          USP, 50 mg/mL.           Pharmaceuticals,
                                                   Inc., 157 Technology
                                                   Dr., Irvine, CA
                                                   92618.
ANDA 087978............  Diphenhydramine HCl      LNK International,
                          Capsules, 50 mg.         Inc., 145 Ricefield
                                                   Ln., Hauppauge, NY
                                                   11788.
ANDA 090417............  Carbinoxamine Maleate    Cypress
                          Tablets USP, 4 mg.       Pharmaceutical, Inc.
ANDA 090418............  Carbinoxamine Maleate     Do.
                          Oral Solution, 4 mg/5
                          mL.
ANDA 090468............  Zyfrel (acetaminophen     Do.
                          and hydrocodone
                          bitartrate) Oral
                          Solution, 325 mg/7.5
                          mg per 15 mL.
ANDA 091034............  Dorzolamide HCl          Zambon S.p.A., c/o
                          Ophthalmic Solution      Camargo
                          USP, EQ 2% base.         Pharmaceutical
                                                   Services, LLC, 9825
                                                   Kenwood Rd., Suite
                                                   203, Cincinnati, OH
                                                   45242.
ANDA 200794............  Pantoprazole Sodium      Sun Pharmaceutical
                          Delayed-Release          Industries, Ltd., c/o
                          Tablets USP, EQ 20 mg    Sun Pharmaceutical
                          base and EQ 40 mg base.  Industries, Inc.
ANDA 206438............  Hydrocodone Bitartrate   Tris Pharma, Inc.,
                          and Chlorpheniramine     2033 Route 130, Suite
                          Maleate Oral Solution,   D, Monmouth Junction,
                          5 mg/4 mg per 5 mL.      NJ 08852.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of March
26, 2018. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on March 26, 2018 may continue to be dispensed until
the inventories have been depleted or the drug products have reached
their expiration dates or otherwise become violative, whichever occurs
first.

    Dated: February 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03700 Filed 2-22-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 230 (Friday, November 29, 2019)]
[Notices]
[Pages 65804-65805]
[FR Doc No: 2019-25909]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14973-000]

Lock+\TM\ Hydro Friends Fund XX, LLC; Notice of
Preliminary Permit Application Accepted for Filing and Soliciting
Comments, Motions To Intervene, and Competing Applications

    On March 1, 2019, Lock+\TM\ Hydro Friends Fund XX, LLC,
filed an application for a preliminary permit, pursuant to section 4(f)
of the Federal Power Act (FPA), proposing to study the feasibility of
the Blue Marsh Dam Hydropower Project to be located at the U.S. Army
Corps of Engineers' (Corps) Blue Marsh Dam on the Tulpehocken Creek in
Berks County, Pennsylvania. The sole purpose of a preliminary permit,
if issued, is to grant the permit holder priority to file a license
application during the permit term. A preliminary permit does not
authorize the permit holder to perform any land-disturbing activities
or otherwise enter upon lands or waters owned by others without the
owners' express permission.
    The proposed project would consist of the following: (1) A new 30-
foot-long, 30-foot-wide, 160-foot-high Large Frame Module; (2) two
turbine-generator units with a total rated capacity of 1.75 megawatts;
(3) a new 4-foot-long, 4-foot-wide, 3-foot-high pad-mounted
transformer; (4) a new 1,650-foot-long, 13-kilovolt transmission line
connecting the new transformer to an existing distribution line; and
(5) appurtenant facilities. The proposed project would have an annual
generation of 7,750 megawatt-hours.
    Applicant Contact: Wayne Krouse, Lock +\TM\ Hydro
Friends Fund XX, LLC, P.O. Box 43796, Birmingham, AL 35243; phone: 877-
556-6566 ext. 709.
    FERC Contact: Woohee Choi; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.\1\

Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
---------------------------------------------------------------------------

    \1\ The Commission is issuing a second notice for this project
because some municipalities may not have been notified by the first
notice issued on August 22, 2019. Any comments filed in response to
either notice will be considered in evaluating the permit
application.
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. The first page of any filing should include
docket number P-14973-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14973) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: November 22, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-25909 Filed 11-27-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: September 29, 2008 (Volume 73, Number 189)]
[Rules and Regulations]
[Page 56468-56470]
[DOCID:fr29se08-9]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0730; Directorate Identifier 2008-NM-055-AD;
Amendment 39-15674; AD 2008-19-07]
RIN 2120-AA64

Airworthiness Directives; Bombardier Model DHC-8-400, DHC-8-401,
and DHC-8-402 Airplanes

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

ACTION: Final rule.

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

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

    All DHC-8 Series 400 aircraft have had a spoiler fuselage cable
disconnect sensing system installed in production. Subsequently it
was discovered that, in the event of a spoiler fuselage cable
disconnect, only the ROLL SPLR INBD HYD caution light will be
illuminated until the aircraft speed decreases below 165 kts
[knots], at which time the ROLL SPLR OUTBD HYD caution light will
also be illuminated. In the event of a spoiler fuselage cable
disconnect in association with the existing indications described
above, the reduction in roll authority could result in increased
pilot workload during approach and landing.
* * * * *
We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective November 3, 2008.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of November 3,
2008.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Dan Parrillo, Aerospace Engineer,
Systems and Flight Test Branch, ANE-172, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on July 2, 2008 (73 FR
37896). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    All DHC-8 Series 400 aircraft have had a spoiler fuselage cable
disconnect sensing system installed in production. Subsequently it
was discovered that, in the event of a spoiler fuselage cable
disconnect, only the ROLL SPLR INBD HYD caution light will be
illuminated until the aircraft speed decreases below 165 kts
[knots], at which time the ROLL SPLR OUTBD HYD caution light will
also be illuminated. In the event of a spoiler fuselage cable
disconnect in association with the existing indications described
above, the reduction in roll authority could result in increased
pilot workload during approach and landing.
    Modsums 4-110066 and 4-126356 (each applicable to a different
batch of aircraft serial numbers) have been issued to rework the
sensing circuit caution light indication to ensure that it is
consistent for spoiler fuselage cable disconnects above and below
165 kts. Modsum 4-126356 has been installed in production on
aircraft serial numbers 4130 and subsequent.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Differences Between This AD and the MCAI or Service Information

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

Costs of Compliance

    We estimate that this AD will affect about 20 products of U.S.
registry. We also estimate that it will take about 10 work-hours per
product to comply with the basic requirements of this AD. The average
labor rate is $80 per work-hour. Required parts will cost about $2,339
per product. Where the service information lists required parts costs
that are covered under warranty, we have assumed that there will be no
charge for these parts. As we do not control warranty coverage for
affected parties, some parties may incur costs higher than estimated
here. Based on these figures, we estimate the cost of this AD to the
U.S. operators to be $62,780, or $3,139 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation Programs''
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-19-07 Bombardier, Inc. (Formerly de Havilland, Inc.): Amendment
39-15674. Docket No. FAA-2008-0730; Directorate Identifier 2008-NM-
055-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective November
3, 2008.

Affected ADs

    (b) None.

Applicability

    (c) Bombardier Model DHC-8-400, DHC-8-401 and DHC-8-402
airplanes, serial numbers 4003, 4004, 4006, and 4008 through 4129,
certificated in any category.

Subject

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

Reason

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

    All DHC-8 Series 400 aircraft have had a spoiler fuselage cable
disconnect sensing system installed in production. Subsequently it
was discovered that, in the event of a spoiler fuselage cable
disconnect, only the ROLL SPLR INBD HYD caution light will be
illuminated until the aircraft speed decreases below 165 kts
[knots], at which time the ROLL SPLR OUTBD HYD caution light will
also be illuminated. In the event of a spoiler fuselage cable
disconnect in association with the existing indications described
above, the reduction in roll authority could result in increased
pilot workload during approach and landing.
    Modsums 4-110066 and 4-126356 (each applicable to a different
batch of aircraft serial numbers) have been issued to rework the
sensing circuit caution light indication to ensure that it is
consistent for spoiler fuselage cable disconnects above and below
165 kts. Modsum 4-126356 has been installed in production on
aircraft serial numbers 4130 and subsequent.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) For airplanes with serial numbers 4003, 4004, 4006, and 4008
through 4094: Within 6,000 flight hours after the effective date of
this AD, modify the spoiler cable disconnect sensing circuit by
incorporating Modsum 4-110066 in accordance with Bombardier Service
Bulletin 84-27-33, dated June 6, 2007.
    (2) For airplanes with serial numbers 4095 through 4129: Within
6,000 flight hours after the effective date of this AD, modify the
spoiler cable disconnect sensing circuit by incorporating Modsum 4-
126356 in accordance with Bombardier Service Bulletin 84-27-28,
Revision B, dated September 25, 2007.
    (3) Installations of Modsum 4-126356 accomplished before the
effective date of this AD according to Bombardier Service Bulletin
84-27-28, dated October 2, 2006; or Revision A, dated April 30,
2007; are considered acceptable for compliance with the
corresponding action specified in this AD.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. Send information to ATTN: Dan Parrillo, Aerospace
Engineer, Systems and Flight Test Branch, ANE-172, FAA, New York
ACO, 1600 Stewart Avenue, Suite 410, Westbury, New York 11590;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before using any
approved AMOC on any airplane to which the AMOC applies, notify your
appropriate principal inspector (PI) in the FAA Flight Standards
District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI Canadian Airworthiness Directive CF-2008-13,
dated February 14, 2008; and Bombardier Service Bulletins 84-27-33,
dated June 6, 2007; and 84-27-28, Revision B, dated September 25,
2007; for related information.

Material Incorporated by Reference

    (i) You must use Bombardier Service Bulletin 84-27-33, dated
June 6, 2007; or Bombardier Service Bulletin 84-27-28, Revision B,
dated September 25, 2007; as applicable; to do the actions required
by this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Bombardier, Inc., Bombardier Regional Aircraft Division, 123 Garratt
Boulevard, Downsview, Ontario M3K 1Y5, Canada.
    (3) You may review copies at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>,
or go to: http://www.archives.gov/federal-register/cfr/ibr-
locations.html.

    Issued in Renton, Washington, on September 11, 2008.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.

[FR Doc. E8-22061 Filed 9-26-08; 8:45 am]

BILLING CODE 4910-13-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Issued by the Department of Transportation on November 7, 2005

NOTICE OF ACTION TAKEN -- DOCKET OST-2004-17733

________________________________________________________________________
________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  AFRICAN INTERNATIONAL AIRWAYS (PROPRIETARY) LIMITED
Date Filed:  June 24, 2005

Relief requested:  Renewal of exemption from 49 U.S.C. § 41301 to
permit the applicant to engage in charter foreign air transportation of
property and mail between South Africa and the United States, and other
all-cargo charters in accordance with 14 CFR Part 212.

If renewal, date and citation of last action:  July 6, 2004, in this
Docket.

Applicant representative:  Moffett B. Roller,<PHONE_NUMBER>
DOT analyst:  Robert J. Finamore,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.
                                          Action date:  November 7, 2005

Effective dates of authority granted:  November 7, 2005, through
November 7, 2006.

Basis for approval (bilateral agreement/reciprocity):  Reciprocity with
South Africa.

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations of our standard exemption conditions
(attached).

Action taken by:   Paul L. Gretch, Director, Office of International
Aviation

________________________________________________________________________
________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

FOREIGN CARRIER EXEMPTION CONDITIONS
                              ATTACHMENT

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

1) Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

2) Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

3) Comply with the requirements for minimum insurance coverage contained
in 14 CFR Part 205, and, prior to the commencement of any operations
under this authority, file evidence of such coverage, in the form of a
completed OST Form 6411, with the Federal Aviation Administration’s
Program Management Branch (AFS-260), Flight Standards Service (any
changes to, or termination of, insurance also shall be filed with that
office);

4) Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

5) Conform to the airworthiness and airman competency requirements of
its Government for international air services;

6) Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

7) Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: a) based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or b) based on
a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term “international air transportation” means “international
transportation” as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

8) Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

9) Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department’s
rules governing charters (including 14 CFR Parts 212 and 380); and

11) Comply with such other reasonable terms, conditions, and limitations
required by the public interest as may be prescribed by the Department,
with all applicable orders or regulations of other U.S. agencies and
courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

 05/2004


[Federal Register: October 18, 2005 (Volume 70, Number 200)]
[Notices]
[Page 60577-60581]
[DOCID:fr18oc05-127]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-27116; 812-13116]

ING Partners, Inc., et al.; Notice of Application

October 12, 2005.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under sections 6(c) and 17(b) of the
Investment Company Act of 1940 (the ``Act'') exempting applicants from
section 17(a) of the Act and under section 12(d)(1)(J) of the Act
exempting applicants from sections 12(d)(1)(A) and 12(d)(1)(B) of the
Act.

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

    Summary of the Application: The order would permit certain
registered open-end management investment companies to acquire shares
of other registered open-end management investment companies or unit
investment trusts that are within or outside the same group of
investment companies as well as a guaranteed rate investment contract
issued by an affiliated insurance company.
    Applicants: ING Partners, Inc. (``IPI''), ING Investors Trust
(``IIT''), ING Variable Insurance Trust (``IVIT''), ING Variable
Products Trust (``IVPT''), ING VP Emerging Markets Fund, Inc.
(``IVPEMF''), ING VP Natural Resources Trust (``IVPNRT'') (the ``ING
Investment Companies''), ING Life Insurance and Annuity Company
(``ILIAC''), ING Investments, LLC (``IIL'') and Directed Services, Inc.
(the ``Advisers'').\1\
---------------------------------------------------------------------------

    \1\ All entities that currently intend to rely on the requested
order are named as applicants and any other entity that relies on
the order in the future will comply with the terms and conditions of
the application. Applicants request that the relief also apply to
any existing or future registered open-end management investment
company that is part of the same group of investment companies as
defined in section 12(d)(1)(G) of the Act as the ING Investment
Companies (included in the term ``ING Investment Companies'') and
any existing or future insurance company controlling, controlled by
or under common control with ILIAC that may issue a guaranteed rate
investment contract (each an ``ING Insurance Company''). Each series
of an ING Investment Company is referred to as a ``Fund'' and
collectively as ``Funds.''
---------------------------------------------------------------------------

    Filing Dates: The application was filed on August 13, 2004 and
amended on April 7, 2005, and September 28, 2005. Applicants have
agreed to file an amendment during the notice period, the substance of
which is reflected in this notice.
    Hearing or Notification of Hearing: An order granting the
application will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on November 7, 2005, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
St., NE., Washington, DC 20549-9303. Applicants, c/o Huey P. Falgout,
Jr., Chief Counsel, ING Americas U.S. Legal Services, 7337 E.
Doubletree Ranch Rd., Scottsdale, Arizona 85258.

FOR FURTHER INFORMATION CONTACT: Marilyn Mann, Senior Counsel, at (202)
551-6813, or Mary Kay Frech, Branch Chief, at<PHONE_NUMBER> (Division
of Investment Management, Office of Investment Company Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained for a fee at the
Commission's Public Reference Branch, 100 F St., NE., Washington, DC
20549-0102 (tel.<PHONE_NUMBER>).

Applicants' Representations

    1. IPI is a Maryland corporation and is registered under the Act as
an open-end management investment company. IPI currently consists of 25
Funds, each with its own investment objective and policies. The shares
of each IPI Fund are offered and sold through registered separate
accounts of insurance companies that are affiliates of the Advisers
(``Registered Separate Accounts'') and unregistered separate accounts
of insurance companies that are affiliates of the Advisers
(``Unregistered Separate Accounts'' and, together with the Registered
Separate Accounts, the ``Separate Accounts''), which are used to fund
variable annuity contracts and variable life insurance contracts, and
may be offered and sold to retirement plans and certain investment
advisers, pursuant to an order granted by the Commission.\2\ IPI has
created 5 new Funds known as the Solutions Portfolios, which will be
managed by ILIAC and each of which will be a fund of funds (``Funds of
Funds''). The Solutions Portfolios are the only Funds of Funds that
currently intend to rely on the requested relief.
---------------------------------------------------------------------------

    \2\ Aetna Variable Fund, Investment Company Act Release Nos.
23545 (Nov. 23, 1998) (notice) and 23616 (Dec. 21, 1998) (order).
---------------------------------------------------------------------------

    2. IIT is a Massachusetts business trust and is registered under
the Act as an open-end management investment company. IIT currently
consists of 46 Funds, each with its own investment objective and
policies. The shares of each IIT Fund currently are offered and sold
through Separate Accounts which are used to fund variable annuity
contracts and variable life insurance contracts, and may be offered and
sold to retirement plans, pursuant to an order granted by the
Commission.\3\
---------------------------------------------------------------------------

    \3\ Id.
---------------------------------------------------------------------------

    3. IVIT is a Delaware statutory trust and is registered under the
Act as an open-end management investment company. IVIT currently
consists of 11 Funds, each with its own investment objective and
policies. IVPT is a Massachusetts business trust and is registered
under the Act as an open-end management investment company. IVPT
currently consists of 10 Funds, each

with its own investment objective and policies. IVPEMF is a Maryland
corporate and is registered under the Act as an open-end management
investment company. IVPEMF currently consists of one Fund. IVPNRT is a
Massachusetts business trust and is registered under the Act as an
open-end management investment company. IVPNRT currently consists of
one Fund.
    4. The Funds of Funds will invest in other Funds (``Affiliated
Underlying Funds'') and in other registered open-end management
investment companies and unit investment trusts that are not part of
the same group of investment companies, as defined in section
12(d)(1)(G) of the Act, as the Funds of Funds (``Unaffiliated
Underlying Funds''). The Affiliated Underlying Funds and the
Unaffiliated Underlying Funds are together the ``Underlying Funds.''
Each Fund of Funds may also make investments in other securities and in
a guaranteed rate investment contract issued by ILIAC or another ING
Insurance Company (the ``ING Guaranteed Contract''). ILIAC and all
other ING Insurance Companies are indirect subsidiaries of ING Groep,
N.V. Applicants state that each Fund of Funds will enable investors to
create a comprehensive asset allocation program with just one
investment and provide a simple, convenient and cost-efficient program
for investors who are able to identify their investment goals and risk
tolerances but may not be comfortable deciding how to invest their
assets to achieve those goals.
    5. Each Adviser is registered with the Commission as an investment
adviser under the Investment Advisers Act of 1940, is a direct or
indirect subsidiary of ING Groep, N.V., and serves as investment
adviser to the Funds. Each investment adviser to a Fund of Funds that
meets the definition of section 2(a)(20)(A) of the Act is referred to
as a ``Fund of Funds Adviser.'' Any investment adviser to a Fund of
Funds that meets the definition in section 2(a)(20)(B) of the Act is
referred to as a ``Fund of Funds Subadviser.''
    6. Applicants request relief to permit the Funds of Funds to
purchase shares of the Underlying Funds in excess of the limits set
forth in section 12(d)(1)(A) of the Act and for the Underlying Funds,
their principal underwriters and any broker or dealer to sell shares of
the Underlying Funds to the Funds of Funds in excess of the limits set
forth in section 12(d)(1)(B) of the Act. Applicants also seek relief
from section 17(a) of the Act to permit Underlying Funds to sell shares
to, and redeem shares from, the Funds of Funds. In addition, applicants
seek relief from section 17(a) of the Act to permit a Fund of Funds to
purchase the ING Guaranteed Contract.

Applicants' Legal Analysis

A. Sections 12(d)(1)(A) and (B) of the Act

    1. Section 12(d)(1)(A) prohibits a registered investment company
from acquiring shares of another registered investment company if the
securities represent more than 3% of the total outstanding voting stock
of the acquired company, more than 5% of the total assets of the
acquiring company or, together with the securities of other investment
companies, more than 10% of the total assets of the acquiring company.
Section 12(d)(1)(B) prohibits a registered open-end investment company,
its principal underwriter and any broker or dealer from selling shares
of the company to another investment company if the sale will cause the
acquiring company to own more than 3% of the acquired company's
outstanding voting stock or more than 10% of the acquired company's
voting stock to be owned by investment companies generally.
    2. Section 12(d)(1)(J) of the Act provides that the Commission may
exempt any person, security or transaction from any provision of
section 12(d)(1), if the exemption is consistent with the public
interest and the protection of investors. Applicants seek an exemption
under section 12(d)(1)(J) to permit Funds of Funds to acquire shares of
Underlying Funds and Underlying Funds to sell their shares to Funds of
Funds, beyond the limits set forth in sections 12(d)(1)(A) and (B).
    3. Applicants state that the proposed arrangement will be
structured to mitigate the potential abuses from which sections
12(d)(1)(A) and (B) are designed to protect investors, such as undue
influence by a fund of funds over underlying funds, excessive layering
of fees and overly complex fund structures. Accordingly, applicants
believe that the requested exemption is consistent with the public
interest and the protection of investors.
    4. Applicants state that the proposed arrangement will not result
in undue influence by a Fund of Funds or its affiliates over any
Underlying Fund. To limit the influence that a Fund of Funds may have
over an Unaffiliated Underlying Fund, applicants propose a condition
prohibiting (a)(i) The Fund of Funds Adviser, (ii) any person
controlling, controlled by or under common control with the Fund of
Funds Adviser and (iii) any investment company or issuer that would be
an investment company but for section 3(c)(1) or 3(c)(7) of the Act
advised or sponsored by the Fund of Funds Adviser or any person
controlling, controlled by or under common control with the Fund of
Funds Adviser (``Group''), and (b)(i) Any Fund of Funds Subadviser,
(ii) any person controlling, controlled by or under common control with
the Fund of Funds Subadviser and (iii) any investment company or issuer
that would be an investment company but for section 3(c)(1) or 3(c)(7)
of the Act (or portion of such investment company or issuer) advised or
sponsored by the Fund of Funds Subadviser or any person controlling,
controlled by or under common control with the Fund of Funds Subadviser
(``Subadviser Group''), from controlling (individually or in the
aggregate) an Unaffiliated Underlying Fund within the meaning of
section 2(a)(9) of the Act.
    5. Applicants also propose conditions 2-7, stated below, to
preclude a Fund of Funds and its affiliated entities from taking
advantage of an Unaffiliated Underlying Fund with respect to
transactions between the entities and to ensure the transactions will
be on an arm's length basis. Condition 2 precludes a Fund of Funds and
its Fund of Funds Adviser, any Fund of Funds Subadviser, promoter,
principal underwriter and any person controlling, controlled by or
under common control with any of these entities (each, a ``Fund of
Funds Affiliate'') from causing any existing or potential investment by
the Fund of Funds in an Unaffiliated Underlying Fund to influence the
terms of any services or transactions between the Fund of Funds or a
Fund of Funds Affiliate and the Unaffiliated Underlying Fund or its
investment adviser(s), sponsor, promoter, principal underwriter and any
person controlling, controlled by or under common control with any of
these entities (each, an ``Unaffiliated Fund Affiliate''). Condition 5
precludes a Fund of Funds or Fund of Funds Affiliate (except to the
extent it is acting in its capacity as an investment adviser to an
Unaffiliated Underlying Fund that is an open-end management investment
company (``Unaffiliated Fund'') or sponsor to an Unaffiliated
Underlying Fund that is a unit investment trust (``Unaffiliated
Trust'')) from causing an Unaffiliated Underlying Fund to purchase a
security in an offering of securities during the existence of any
underwriting or selling syndicate of which a principal underwriter is
an officer, director, member of an advisory board, Fund of Funds
Adviser, Fund of Funds

Subadviser, sponsor or employee of the Fund of Funds, or a person of
which any such officer, director, member of an advisory board, Fund of
Funds Adviser, Fund of Funds Subadviser, sponsor or employee is an
affiliated person (each, an ``Underwriting Affiliate,'' except any
person whose relationship to the Unaffiliated Underlying Fund is
covered by section 10(f) of the Act is not an Underwriting Affiliate).
An offering of securities during the existence of any underwriting or
selling syndicate of which a principal underwriter is an Underwriting
Affiliate is an ``Affiliated Underwriting.''
    6. In addition, as an assurance that an Unaffiliated Fund
understands the implications of an investment by a Fund of Funds
operating in reliance on the requested relief from sections 12(d)(1)(A)
and (B), prior to any investment by the Fund of Funds in the
Unaffiliated Fund in excess of the limit set forth in section
12(d)(1)(A)(i), condition 10 requires the Fund of Funds and the
Unaffiliated Fund to execute an agreement stating, without limitation,
that their boards and their investment adviser understand the terms and
conditions of the order and agree to fulfill their responsibilities
under the order. Applicants note that an Unaffiliated Underlying Fund
has the right to reject an investment from a Fund of Funds.
    7. Applicants do not believe that the proposed arrangement will
involve excessive layering of fees. With respect to investment advisory
fees, applicants state that, prior to the approval of any investment
advisory contract under section 15 of the Act, the board of directors
or trustees (``Board'') of a Fund of Funds, including a majority of the
directors or trustees who are not ``interested persons,'' as defined in
section 2(a)(19) of the Act (``Disinterested Trustees''), will find
that any investment advisory fees charged to the Fund of Funds under
its investment advisory contract are based on services provided that
are in addition to, rather than duplicative of, services provided under
the investment advisory contract(s) of any Underlying Fund. Applicants
further state that the Fund of Funds Adviser will waive or offset fees
otherwise payable to it by the Fund of Funds in an amount at least
equal to any compensation (including fees received pursuant to a plan
adopted by an Unaffiliated Fund under rule 12b-1 under the Act)
received from an Unaffiliated Underlying Fund by the Fund of Funds
Adviser, or an affiliated person of the Fund of Funds Adviser, other
than any advisory fees paid to the Fund of Funds Adviser or its
affiliated person by an Unaffiliated Fund, in connection with the
investment by the Fund of Funds in the Unaffiliated Underlying Fund.
Applicants also state that any Fund of Funds Subadviser will waive fees
otherwise payable to the Fund of Funds Subadviser, directly or
indirectly, by the Fund of Funds in an amount at least equal to any
compensation received from an Unaffiliated Underlying Fund by the Fund
of Funds Subadviser, or an affiliated person of the Fund of Funds
Subadviser, other than any advisory fees paid to the Fund of Funds
Subadviser or its affiliated person, in connection with the investment
by the Fund of Funds in the Unaffiliated Underlying Fund made at the
direction of the Fund of Funds Subadviser. Applicants agree that the
benefit of any such waiver by a Fund of Funds Subadviser will be passed
through to the Fund of Funds.
    8. Applicants represent that the aggregate sales charges and/or
service fees (as defined in the Conduct Rules of the NASD (``NASD
Conduct Rules'')) charged with respect to shares of any Fund of Funds
will not exceed the limits applicable to funds of funds set forth in
rule 2830 of the NASD Conduct Rules. Moreover, the prospectus and sales
literature of a Fund of Funds will contain concise, ``plain English''
disclosure tailored to the particular document designed to inform
investors of the unique characteristics of the fund of funds structure
including, but not limited to, its expense structure and the additional
expenses of investing in Underlying Funds.
    9. Applicants contend that the proposed arrangement will not create
an overly complex fund structure. Applicants note that Underlying Funds
will be prohibited from acquiring securities of any investment company
or company relying on section 3(c)(1) or 3(c)(7) of the Act in excess
of the limits contained in section 12(d)(1)(A), except to the extent
that an Underlying Fund (a) receives securities of another investment
company as a dividend or as a result of a plan of reorganization of a
company (other than a plan devised for the purpose of evading section
12(d)(1)), or (b) acquires (or is deemed to have acquired) securities
of another investment company pursuant to exemptive relief from the
Commission permitting such Underlying Fund to (i) acquire securities of
one or more affiliated investment companies for short-term cash
management purposes or (ii) engage in interfund borrowing and lending
transactions.

B. Section 17(a) of the Act

    1. Section 17(a) generally prohibits purchases and sales of
securities, on a principal basis, between a registered investment
company and any affiliated person or promoter of, or principal
underwriter for, the company, and affiliated persons of such persons.
Section 2(a)(3) of the Act defines an ``affiliated person'' of another
person to include, among other things, any person directly or
indirectly owning, controlling or holding with power to vote 5% or more
of the other's outstanding voting securities; any person 5% or more of
whose outstanding voting securities are directly or indirectly owned,
controlled or held with power to vote by the other person; any person
directly or indirectly controlling, controlled by or under common
control with the other person; and any investment adviser to an
investment company.
    2. Section 17(b) authorizes the Commission to grant an order
permitting a transaction otherwise prohibited by section 17(a) if it
finds that (a) the terms of the proposed transaction, including the
consideration to be paid and received, are fair and reasonable and do
not involve overreaching on the part of any person concerned; (b) the
proposed transaction is consistent with the policies of each registered
investment company concerned; and (c) the proposed transaction is
consistent with the general purposes of the Act. Section 6(c) permits
the Commission to exempt any person or transaction, or any class or
classes of persons or transactions from any provisions of the Act, if
such exemption is necessary or appropriate in the public interest and
consistent with the protection of investors and the purposes fairly
intended by the policy and provisions of the Act.
    3. Applicants state that an Underlying Fund might be deemed to be
an affiliated person of a Fund of Funds if the Fund of Funds acquires
5% or more of the Underlying Fund's outstanding voting securities.
Applicants also state that since the Funds of Funds and Affiliated
Underlying Funds will be advised by an Adviser, they may be deemed to
be under common control and, therefore, affiliated persons of each
other. Accordingly, section 17(a) could prevent an Underlying Fund from
selling shares to, and redeeming shares from, a Fund of Funds.
Applicants state that the consideration paid in sales and redemptions
permitted under the requested order of shares of Underlying Funds will
be based on the net asset values of the Underlying Funds.

    4. ILIAC or another ING Insurance Company will issue an ING
Guaranteed Contract to the Funds of Funds. ILIAC also may serve as
investment adviser to a Fund of Funds and may also be the record owner
of 5% or more of the shares of a Fund of Funds and thus may be deemed
to be an affiliated person of the Fund of Funds. The purchase by a Fund
of Funds of an ING Guaranteed Contract would therefore be prohibited by
section 17(a). Applicants submit that the ING Guaranteed Contract will
bear a fixed rate of interest which will be at least as favorable as
the guaranteed rate on substantially similar guaranteed contracts
offered by the ING Insurance Companies and other insurance companies.
Applicants further submit that the Funds of Funds may withdraw assets
from the ING Guaranteed Contract at any time if the rate becomes non-
competitive (or for any other reason) without the imposition of any
sales charge or market value adjustment.
    5. Applicants seek an exemption under sections 6(c) and 17(b) to
allow the proposed transactions. Applicants state that the transactions
satisfy the standards for relief under sections 6(c) and 17(b).
Applicants represent that the proposed transactions will be consistent
with the policies of each Fund of Funds and Underlying Fund and with
the general purposes of the Act.

Applicants' Conditions

    Applicants agree that the order granting the requested relief shall
be subject to the following conditions:
    1. The members of the Group will not control (individually or in
the aggregate) an Unaffiliated Underlying Fund within the meaning of
section 2(a)(9) of the Act. The members of a Subadviser Group will not
control (individually or in the aggregate) an Unaffiliated Underlying
Fund within the meaning of section 2(a)(9) of the Act. If, as a result
of a decrease in the outstanding voting securities of an Unaffiliated
Underlying Fund, the Group or the Subadviser Group, each in the
aggregate, becomes a holder of more than 25% of the outstanding voting
securities of the Unaffiliated Underlying Fund, then the Group or the
Subadviser Group (except for any member of the Group or the Subadviser
Group that is a Separate Account) will vote its shares of the
Unaffiliated Underlying Fund in the same proportion as the vote of all
other holders of the Unaffiliated Underlying Fund's shares. A
Registered Separate Account will seek voting instructions from its
contract holders and will vote its shares in accordance with the
instructions received and will vote those shares for which no
instructions were received in the same proportion as the shares for
which instructions were received. An Unregistered Separate Account will
either (i) vote its shares of the Unaffiliated Underlying Fund in the
same proportion as the vote of all other holders of the Unaffiliated
Underlying Fund's shares; or (ii) seek voting instructions from its
contract holders and vote its shares in accordance with the
instructions received and vote those shares for which no instructions
were received in the same proportion as the shares for which
instructions were received. This condition shall not apply to a
Subadviser Group with respect to an Unaffiliated Underlying Fund for
which the Fund of Funds Subadviser or person controlling, controlled by
or under common control with the Fund of Funds Subadviser acts as the
investment adviser within the meaning of section 2(a)(20)(A) of the Act
(in the case of an Unaffiliated Fund) or as the sponsor (in the case of
an Unaffiliated Trust).
    2. No Fund of Funds or Fund of Funds Affiliate will cause any
existing or potential investment by the Fund of Funds in shares of an
Unaffiliated Underlying Fund to influence the terms of any services or
transactions between the Fund of Funds or a Fund of Funds Affiliate and
the Unaffiliated Underlying Fund or an Unaffiliated Fund Affiliate.
    3. The Board of each Fund of Funds, including a majority of the
Disinterested Trustees, will adopt procedures reasonably designed to
assure that the Fund of Funds Adviser and any Fund of Funds Subadviser
are conducting the investment program of the Fund of Funds without
taking into account any consideration received by the Fund of Funds or
a Fund of Funds Affiliate from an Unaffiliated Underlying Fund or an
Unaffiliated Fund Affiliate in connection with any services or
transactions.
    4. Once an investment by a Fund of Funds in the securities of an
Unaffiliated Fund exceeds the limit of section 12(d)(1)(A)(i) of the
Act, the Board of the Unaffiliated Fund, including a majority of the
Disinterested Trustees, will determine that any consideration paid by
the Unaffiliated Fund to a Fund of Funds or a Fund of Funds Affiliate
in connection with any services or transactions: (a) Is fair and
reasonable in relation to the nature and quality of the services and
benefits received by the Unaffiliated Fund; (b) is within the range of
consideration that the Unaffiliated Fund would be required to pay to
another unaffiliated entity in connection with the same services or
transactions; and (c) does not involve overreaching on the part of any
person concerned. This condition does not apply with respect to any
services or transactions between an Unaffiliated Fund and its
investment adviser(s), or any person controlling, controlled by or
under common control with such investment adviser(s).
    5. No Fund of Funds or Fund of Funds Affiliate (except to the
extent it is acting in its capacity as an investment adviser to an
Unaffiliated Fund or sponsor to an Unaffiliated Trust) will cause an
Unaffiliated Underlying Fund to purchase a security in an Affiliated
Underwriting.
    6. The Board of an Unaffiliated Fund, including a majority of the
Disinterested Trustees, will adopt procedures reasonably designed to
monitor any purchases of securities by the Unaffiliated Fund in an
Affiliated Underwriting, once an investment by a Fund of Funds in the
securities of the Unaffiliated Fund exceeds the limit of section
12(d)(1)(A)(i) of the Act, including any purchases made directly from
an Underwriting Affiliate. The Board of the Unaffiliated Fund will
review these purchases periodically, but no less frequently than
annually, to determine whether the purchases were influenced by the
investment by the Fund of Funds in shares of the Unaffiliated Fund. The
Board of the Unaffiliated Fund will consider, among other things, (a)
whether the purchases were consistent with the investment objectives
and policies of the Unaffiliated Fund; (b) how the performance of
securities purchased in an Affiliated Underwriting compares to the
performance of comparable securities purchased during a comparable
period of time in underwritings other than Affiliated Underwritings or
to a benchmark such as a comparable market index; and (c) whether the
amount of securities purchased by the Unaffiliated Fund in Affiliated
Underwritings and the amount purchased directly from an Underwriting
Affiliate have changed significantly from prior years. The Board will
take any appropriate actions based on its review, including, if
appropriate, the institution of procedures designed to assure that
purchases of securities in Affiliated Underwritings are in the best
interest of shareholders.
    7. Each Unaffiliated Fund will maintain and preserve permanently in
an easily accessible place a written copy of the procedures described
in the preceding condition, and any modifications to such procedures,
and will maintain and preserve for a period of not less than six years
from the end of the fiscal year in which any purchase

in an Affiliated Underwriting occurred, the first two years in an
easily accessible place, a written record of each purchase made once an
investment by a Fund of Funds in the securities of an Unaffiliated Fund
exceeds the limit of section 12(d)(1)(A)(i) of the Act, setting forth
from whom the securities were acquired, the identity of the
underwriting syndicate's members, the terms of the purchase, and the
information or materials upon which the determinations of the
Unaffiliated Fund's Board were made.
    8. A Fund of Funds will pay no sales load when purchasing an ING
Guaranteed Contract, and will be permitted to remove its assets from an
ING Guaranteed Contract at any time without the imposition of a sales
charge or market value adjustment.
    9. Prior to purchasing an ING Guaranteed Contract, and prior to any
periodic adjustment to the rate of interest on an ING Guaranteed
Contract held by a Fund of Funds, the Board of the Fund of Funds,
including a majority of the Disinterested Trustees, will make a
determination that (i) purchasing or maintaining, as applicable, the
ING Guaranteed Contract is in the best interests of the Fund of Funds
and its shareholders and does not involve overreaching on the part of
any person concerned, and (ii) the guaranteed rate on the ING
Guaranteed Contract is at least as favorable as the guaranteed rate on
substantially similar guaranteed contracts offered by the ING Insurance
Companies and other insurance companies. This determination, and the
information upon which it was based, will be recorded fully in the
minute books of the Fund of Funds.
    10. Prior to an investment in shares of an Unaffiliated Fund in
excess of the limit in section 12(d)(1)(A)(i), the Fund of Funds and
the Unaffiliated Fund will execute an agreement stating, without
limitation, that their boards of directors or trustees and their
investment advisers understand the terms and conditions of the order
and agree to fulfill their responsibilities under the order
(``Participation Agreement''). At the time of its investment in shares
of an Unaffiliated Fund in excess of the limit in section
12(d)(1)(A)(i), a Fund of Funds will notify the Unaffiliated Fund of
the investment. At such time, the Fund of Funds also will transmit to
the Unaffiliated Fund a list of the names of each Fund of Funds
Affiliate and Underwriting Affiliate. The Fund of Funds will notify the
Unaffiliated Fund of any changes to the list as soon as reasonably
practicable after a change occurs. The Unaffiliated Fund and the Fund
of Funds will maintain and preserve a copy of the order, the
Participation Agreement, and the list with any updated information for
the duration of the investment and for a period of not less than six
years thereafter, the first two years in an easily accessible place.
    11. Prior to approving any investment advisory or management
contract under section 15 of the Act, the Board of each Fund of Funds,
including a majority of the Disinterested Trustees, will find that the
advisory or management fees charged under such contract are based on
services provided that are in addition to, rather than duplicative of,
the services provided under the advisory contract(s) of any Affiliated
Underlying Funds or Unaffiliated Funds in which the Fund of Funds may
invest. This finding, and the basis upon which the finding was made,
will be recorded fully in the minute books of the Fund of Funds.
    12. The Fund of Funds Adviser will waive or offset fees otherwise
payable to it by the Fund of Funds in an amount at least equal to any
compensation (including fees received pursuant to a plan adopted by an
Unaffiliated Fund under rule 12b-1 under the Act) received by the Fund
of Funds Adviser or an affiliated person of the Fund of Funds Adviser
from an Unaffiliated Underlying Fund, other than any advisory fees paid
to the Fund of Funds Adviser or its affiliated person by an
Unaffiliated Fund, in connection with the investment by the Fund of
Funds in the Unaffiliated Underlying Fund. Any Fund of Funds Subadviser
will waive fees otherwise payable to the Fund of Funds Subadviser,
directly or indirectly, by the Fund of Funds in an amount at least
equal to any compensation received from an Unaffiliated Underlying Fund
by the Fund of Funds Subadviser, or an affiliated person of the Fund of
Funds Subadviser, other than any advisory fees paid to the Fund of
Funds Subadviser or its affiliated person by the Unaffiliated Fund, in
connection with the investment by the Fund of Funds in the Unaffiliated
Underlying Fund made at the direction of the Fund of Funds Subadviser.
In the event that the Fund of Funds Subadviser waives fees, the benefit
of the waiver will be passed through to the Fund of Funds.
    13. With respect to Registered Separate Accounts that invest in a
Fund of Funds, no sales load will be charged at the Fund of Funds level
or at the Underlying Fund level. Other sales charges and service fees,
as defined in rule 2830 of the Conduct Rules of the NASD, if any, will
only be charged at the Fund of Funds level or at the Underlying Fund
level, not both. With respect to other investments in a Fund of Funds,
any sales charges and/or service fees charged with respect to shares of
a Fund of Funds will not exceed the limits applicable to funds of funds
set forth in rule 2830 of the Conduct Rules of the NASD.
    14. No Underlying Fund will acquire securities of any other
investment company or company relying on section 3(c)(1) or 3(c)(7) of
the Act in excess of the limits contained in section 12(d)(1)(A) of the
Act, except to the extent that such Underlying Fund (i) receives
securities of another investment company as a dividend or as a result
of a plan of reorganization of a company (other than a plan devised for
the purpose of evading Section 12(d)(1) of the Act); or (ii) acquires
(or is deemed to have acquired) securities of another investment
company pursuant to exemptive relief from the Commission permitting
such Underlying Fund to (a) acquire securities of one or more
affiliated investment companies for short-term cash management
purposes, or (b) engage in interfund borrowing and lending
transactions.
    15. The Board of any Fund of Funds will satisfy the fund governance
standards as defined in rule 0-1(a)(7) under the Act (``Governance
Standards'') by the later of (i) the compliance date for the rule
(``Compliance Date'') or (ii) the earlier of the date of reliance on
the order or the date on which the Fund of Funds executes a
Participation Agreement. The Board of any Unaffiliated Fund will
satisfy the Governance Standards by the later of (i) the Compliance
Date or (ii) the date on which the Unaffiliated Fund executes a
Participation Agreement.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. E5-5735 Filed 10-17-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 85, Number 18 (Tuesday, January 28, 2020)]
[Notices]
[Pages 4981-4982]
[FR Doc No: 2020-01346]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0654; FRL-10003-73]

Agency Information Collection Activities; Proposed Renewal of an
Existing Collection (EPA ICR No. 2559.03; OMB Control No. 2070-0202);
Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this
document announces that EPA is planning to submit an Information
Collection Request (ICR) to the Office of Management and Budget (OMB).
The ICR, entitled: ``Procedures for Requesting a Chemical Risk
Evaluation under TSCA'' and identified by EPA ICR No. 2559.03 and OMB
Control No. 2070-0202, which represents the renewal of an existing ICR
that is scheduled to expire on September 30, 2020. Before submitting
the ICR to OMB for review and approval, EPA is soliciting comments on
specific aspects of the proposed information collection that is
summarized in this document. The ICR and accompanying material are
available in the docket for public review and comment.

DATES: Comments must be received on or before March 30, 2020.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2016-0654, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Susanna Blair, Immediate Office,
(Mail Code 7401M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)),
EPA specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What information collection activity or ICR does this action apply
to?

    Title: Procedures for Requesting a Chemical Risk Evaluation under
TSCA.
    ICR number: EPA ICR No. 2559.03.
    OMB control number: OMB Control No. 2070-0202.
    ICR status: This ICR is currently scheduled to expire on September
30, 2020. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the Code of Federal Regulations (CFR), after
appearing in the Federal Register when approved, are listed in 40 CFR
part 9, are displayed either by publication in the Federal Register or
by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
for certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: The information collection activities covered by this ICR
renewal are those carried out by a chemical manufacturer in requesting
a specific chemical risk evaluation under the Toxic Substance Control
Act (TSCA) be conducted by EPA. EPA established the process for
conducting risk evaluations under TSCA. Chemicals that will undergo
this evaluation include chemicals the Agency has prioritized, as well
as chemicals for which EPA has granted requests made by manufacturers
to have the chemicals evaluated under EPA's risk evaluation process.
EPA has established criteria and information chemical manufacturers
must provide for EPA to consider a chemical substance for risk
evaluation. This information is necessary in order for EPA to review
information covered by chemical manufacturers and determine if the
chemical substance is suitable for risk evaluation.
    Legal authority: The Toxic Substances Control Act (TSCA), 15 U.S.C.
2605(b)(4).
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to 419.15 hours.
Burden is defined in 5 CFR 1320.3(b).
    The ICR, which is available in the docket along with other related
materials, provides a detailed explanation of the collection activities
and the burden estimate that is only briefly summarized here:
    Respondents/Affected Entities: Entities potentially affected by
this ICR are persons that manufacture chemical substances and request a
chemical be considered for risk evaluation by EPA.
    Estimated total number of potential respondents: 5.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 419.15 hours.
    Estimated total annual costs: $283,570. This includes an estimated
burden cost of $283,570 and an estimated cost of $0 for capital
investment or maintenance and operational costs.

III. Are there changes in the estimates from the last approval?

    There is no change in burden hours, and an increase of $709 in the
total estimated respondent burden compared with that identified in the
ICR currently approved by OMB. This increase reflects the increase in
wage rates since the initial ICR. This change is an adjustment.

IV. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the technical person listed under
FOR FURTHER INFORMATION CONTACT.

    Authority: 44 U.S.C. 3501 et seq.

    Dated: January 17, 2020.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2020-01346 Filed 1-27-20; 8:45 am]
 BILLING CODE 6560-50-P