[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)]
[Notices]
[Pages 65655-65656]
[FR Doc No: 2016-22933]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0072]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
November 22, 2016. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by March 22,
2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-E-0072 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; FYCOMPA.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may

have occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a human drug product will
include all of the testing phase and approval phase as specified in 35
U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product FYCOMPA
(perampanel). FYCOMPA is indicated as adjunctive therapy for the
treatment of partial-onset seizures with or without secondarily
generalized seizures in patients with epilepsy aged 12 years and older.
Subsequent to this approval, the USPTO received a patent term
restoration application for FYCOMPA (U.S. Patent No. 6,949,571) from
Eisai R&D Management Co., Ltd., and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated March 26, 2014, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of FYCOMPA represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
FYCOMPA is 3,274 days. Of this time, 2,968 days occurred during the
testing phase of the regulatory review period, while 306 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: November 7, 2003. FDA has verified the Eisai R&D Management
Co., Ltd. claim that November 7, 2003, is the date the investigational
new drug application became effective.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
22, 2011. The applicant claims May 25, 2011, as the date that the new
drug application (NDA) for Fycompa (NDA 202834) was initially
submitted. However, FDA records indicate that NDA 202834, received May
25, 2011, was not sufficiently complete to permit a substantive review.
FDA refused to file this application and notified the applicant of this
fact by letter dated July 21, 2011. The completed NDA was then
submitted on December 22, 2011, which is considered to be the date that
the NDA was initially submitted within the meaning of 35 U.S.C.
156(g)(B)(ii).
    3. The date the application was approved: October 22, 2012. FDA has
verified the applicant's claim that NDA 202834 was approved on October
22, 2012.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,549 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: September 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22933 Filed 9-22-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)]
[Notices]
[Pages 13343-13344]
[FR Doc No: 2018-06196]

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DEPARTMENT OF TRANSPORTATION

Bureau of Transportation Statistics

[Docket DOT-OST-2014-0031 BTS Paperwork Reduction Notice]

Agency Information Collection; Activity Under OMB Review;
Reporting Required for International Civil Aviation Organization (ICAO)

AGENCY: Office of the Assistant Secretary for Research and Technology
(OST-R), Bureau of Transportation Statistics (BTS), Department of
Transportation.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, Public
Law 104-13, the Bureau of Transportation Statistics invites the general
public, industry and other governmental parties to comment on the
continuing need and usefulness of BTS collecting supplemental data for
the International Civil Aviation Organization (ICAO). Comments are
requested concerning whether (1) the supplemental reports are needed by
BTS to fulfill the United States treaty obligation of furnishing
financial and traffic reports to ICAO; (2) BTS accurately estimated the
reporting burden; (3) there are other ways to enhance the quality,
utility and clarity of the information collected; and (4) there are
ways to minimize reporting

burden, including the use of automated collection techniques or other
forms of information technology.

DATES: Written comments should be submitted by May 29, 2018.

ADDRESSES: You may submit comments identified by DOT Docket ID Number
DOT-OST-2014-0031 OMB Approval No. 2138-0039 by any of the following
methods:
    Federal eRulemaking Portal: Go to http://www.regulations.gov.
Follow the online instructions for submitting comments.
    Mail: Docket Services: U.S. Department of Transportation, 1200 New
Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington,
DC 20590-0001.
    Hand Delivery or Courier: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m. ET, Monday through
Friday, except Federal holidays.
    Fax:<PHONE_NUMBER>.
    Instructions: Identify docket number, DOT-OST-2014-0031, at the
beginning of your comments, and send two copies. To receive
confirmation that DOT received your comments, include a self-addressed
stamped postcard. Internet users may access all comments received by
DOT at http://www.regulations.gov. All comments are posted
electronically without charge or edits, including any personal
information provided.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://DocketInfo.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov. or the street
address listed above. Follow the online instructions for accessing the
dockets.

Electronic Access

    An electronic copy of this rule, a copy of the notice of proposed
rulemaking, and copies of the comments may be downloaded at http://www.regulations.gov, by searching docket DOT-OST-2014-0031.

FOR FURTHER INFORMATION CONTACT: [email protected], Office of Airline
Information, RTS-42, Room E34, OST-R, 1200 New Jersey Avenue Street SE,
Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:
    OMB Approval No.: 2138-0039.
    Title: Reporting Required for International Civil Aviation
Organization (ICAO).
    Form No.: BTS Form EF.
    Type of Review: Extension of a currently approved collection.
    Respondents: Large certificated air carriers.
    Number of Respondents: 34.
    Number of Responses: 34.
    Total Annual Burden: 23 hours.
    Needs and Uses: As a party to the Convention on International Civil
Aviation (Treaty), the United States is obligated to provide ICAO with
financial and statistical data on operations of U.S. carriers. Over 99%
of the data filled with ICAO is extracted from the air carriers' Form
41 submissions to BTS. BTS Form EF is the means by which BTS supplies
the remaining 1% of the air carrier data to ICAO.
    The Confidential Information Protection and Statistical Efficiency
Act of 2002 (44 U.S.C. 3501 note), requires a statistical agency to
clearly identify information it collects for non-statistical purposes.
BTS hereby notifies the respondents and the public that BTS uses the
information it collects under this OMB approval for non-statistical
purposes including, but not limited to, publication of both
Respondent's identity and its data, submission of the information to
agencies outside BTS for review, analysis and possible use in
regulatory and other administrative matters.

    Issued in Washington, DC, on March 20, 2018.
William Chadwick, Jr.,
Director, Office of Airline Information, Bureau of Transportation
Statistics.
[FR Doc. 2018-06196 Filed 3-27-18; 8:45 am]
 BILLING CODE 4910-9X-P


[Federal Register Volume 87, Number 161 (Monday, August 22, 2022)]
[Notices]
[Pages 51405-51406]
[FR Doc No: 2022-18043]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER22-2178-001.
    Applicants: ORNI 50 LLC.
    Description: Tariff Amendment: Amendment to be effective 6/24/2022.
    Filed Date: 8/16/22.
    Accession Number: 20220816-5027.
    Comment Date: 5 p.m. ET 8/30/22.

    Docket Numbers: ER22-2187-000; ER22-2188-000.
    Applicants: Northwest Ohio IA, LLC, Northwest Ohio Solar, LLC.
    Description: Supplement to June 24, 2022 Northwest Ohio Solar, LLC,
et al. tariff filing.
    Filed Date: 8/12/22.
    Accession Number: 20220812-5237.
    Comment Date: 5 p.m. ET 9/2/22.

    Docket Numbers: ER22-2246-000.
    Applicants: BCE Los Alamitos, LLC.
    Description: Report Filing: Supplement to Market-Based Rate
Application to be effective N/A.
    Filed Date: 8/16/22.
    Accession Number: 20220816-5061.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2337-000.
    Applicants: New Hampshire Industries, Inc.
    Description: Notice of Cancellation of Market Based Rate Tariff of
New Hampshire Industries, Inc.
    Filed Date: 7/7/22.
    Accession Number: 20220707-5224.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2646-001.
    Applicants: Graphite Solar 1, LLC.
    Description: Notice of Non-Material Change in Status of Graphite
Solar I, LLC.
    Filed Date: 8/16/22.
    Accession Number: 20220816-5110.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2663-000.
    Applicants: Aron Energy Prepay 15 LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 10/15/2022.
    Filed Date: 8/15/22.
    Accession Number: 20220815-5168.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2664-000.
    Applicants: Aron Energy Prepay 16 LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 10/15/2022.
    Filed Date: 8/15/22.
    Accession Number: 20220815-5170.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2665-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Notice of Cancellation of WMPA, SA
No. 6021; Queue No. AG1-064 to be effective 8/23/2022.
    Filed Date: 8/16/22.
    Accession Number: 20220816-5011.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2666-000.
    Applicants: Cheyenne Light, Fuel and Power Company.
    Description: Tariff Amendment: Notice of Cancellation of Service
Agreement No. 101 to be effective 7/19/2022.
    Filed Date: 8/16/22.
    Accession Number: 20220816-5079.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2667-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc. submits Capital Budget Quarterly
Filing for Second Quarter of 2022.
    Filed Date: 8/11/22.
    Accession Number: 20220811-5164.
    Comment Date: 5 p.m. ET 9/1/22.

    Docket Numbers: ER22-2668-000.
    Applicants: Wisconsin Electric Power Company.
    Description: Sec.  205(d) Rate Filing: Formula Rate Update Filing
for 2021 Rate Year to be effective 10/16/2022.
    Filed Date: 8/16/22.
    Accession Number: 20220816-5090.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2669-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Second Revised No. 3518
NITSA among PJM and LGE/KU to be effective 6/1/2023.
    Filed Date: 8/16/22.
    Accession Number: 20220816-5104.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2670-000.
    Applicants: Alabama Power Company, Georgia Power Company,
Mississippi Power Company.
    Description: Sec.  205(d) Rate Filing: Alabama Power Company
submits tariff filing per 35.13(a)(2)(iii: Blackbriar Farm LGIA Filing
to be effective 8/8/2022.
    Filed Date: 8/16/22.
    Accession Number: 20220816-5105.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2671-000.
    Applicants: Georgia Power Company.
    Description: Initial rate filing: SR Ailey Affected System
Construction Agreement Filing to be effective 8/2/2022.
    Filed Date: 8/16/22.
    Accession Number: 20220816-5117.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: ER22-2672-000.
    Applicants: American Municipal Power, Inc., PJM Interconnection,
L.L.C.
    Description: Sec.  205(d) Rate Filing: American Municipal Power,
Inc. submits tariff filing per 35.13(a)(2)(iii: Second Revised Service
Agreement No. 4264--NITSA among PJM and AMP to be effective 8/3/2022.
    Filed Date: 8/16/22.
    Accession Number: 20220816-5124.
    Comment Date: 5 p.m. ET 9/6/22.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 16, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-18043 Filed 8-19-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Rules and Regulations]
[Page 78912]
[FR Doc No: 2016-27184]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-1004]

Drawbridge Operation Regulation; Great Channel, Between Stone
Harbor and Nummy Island, NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Cape May County (Ocean Drive/CR619)
Bridge across the Great Channel, mile 0.7, between Stone Harbor and
Nummy Island, NJ. This deviation is necessary to avoid bridge failure
and perform emergency bridge repairs. This deviation allows the bridge
to remain in the closed-to-navigation position.

DATES: This deviation is effective without actual notice from November
10, 2016 through 4 p.m. on December 2, 2016. For the purposes of
enforcement, actual notice will be used from November 7, 2016 at 9
a.m., until November 10, 2016.

ADDRESSES: The docket for this deviation, [USCG-2016-1004] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Hal R. Pitts, Bridge
Administration Branch Fifth District, Coast Guard, telephone 757-398-
6222, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The County of Cape May, NJ, that owns and
operates the Cape May County (Ocean Drive/CR619) Bridge, across the
Great Channel, mile 0.7, between Stone Harbor and Nummy Island, NJ, has
requested a temporary deviation from the current operating regulations
to avoid bridge failure and perform emergency repairs to the bridge,
due to mechanical failure of the bascule span motor break, machinery
brakes, and span lock mechanisms. The bridge is a bascule draw bridge
and has a vertical clearance in the closed position of 11 feet above
mean high water.
    The current operating schedule is set out in 33 CFR 117.720. Under
this temporary deviation, the bridge will remain in the closed-to-
navigation position until 4 p.m. on December 2, 2016.
    The Great Channel is used by a variety of vessels including small
public vessels, commercial vessels, and recreational vessels. The Coast
Guard has carefully considered the nature and volume of vessel traffic
on the waterway in publishing this temporary deviation.
    Vessels able to safely pass through the bridge in the closed
position may do so at any time. The bridge will not be able to open for
emergencies and Grassy Sound Channel (Ocean Drive/CR619) Bridge, across
Grassy Sound Channel, mile 1.0, at North Wildwood, NJ, can be used as
an alternate route for vessels unable to pass through the bridge in the
closed position. The Coast Guard will also inform the users of the
waterways through our Local and Broadcast Notices to Mariners of the
change in operating schedule for the bridge so that vessel operators
can arrange their transit to minimize any impact caused by the
temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: November 7, 2016.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2016-27184 Filed 11-9-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: January 24, 2011 (Volume 76, Number 15)]
[Notices]
[Page 4119-4120]
[DOCID:fr24ja11-64]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0381]

Generic Drug User Fee; Notice of Public Meeting; Reopening of the
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until
February 23, 2011, the comment period for the notice of public meeting
entitled Generic Drug User Fee; Public Meeting; Request for Comments,
published in the Federal Register of August 9, 2010 (75 FR 47820). In
that notice, FDA announced a public meeting that took place on
September 17, 2010, to gather stakeholder input on the development of a
generic drug user fee program. FDA is reopening the comment period to
permit public consideration of late-received comments and to provide an
opportunity for all interested parties to provide information and share
views on the matter.

DATES: Submit either electronic or written comments by February 23,
2011.

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

FOR FURTHER INFORMATION CONTACT: Peter C. Beckerman, Office of Policy,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm.
4238, Silver Spring, MD 20993.<PHONE_NUMBER>. FAX:<PHONE_NUMBER>. e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 9, 2010 (75 FR 47820), FDA
published a notice of a public meeting on the development of a generic
drug user fee program. In that notice, FDA posed several questions
related to a user fee for human generic drugs, and sought public input
on such a program. The Agency received submissions and presentations
from the public meeting, which are now posted on FDA's Web site. In the
Federal Register of November 4, 2010 (75 FR 67984), FDA subsequently
reopened the comment period for 30 days to allow consideration of
submissions received after the original docket closing date. Because
FDA has since received multiple requests to reopen the docket,
including requests from generic industry segments that did not
previously comment, FDA has decided to reopen the docket to permit
public input on all the submissions.
    Interested persons were originally given until October 17, 2010, to
comment on the development of a generic drug user fee program. FDA is
now reopening the docket to permit comment until February 23, 2011.

II. Request for Comments

    FDA has received several requests to allow interested persons
additional time to comment. The requesters represent manufacturers of
active pharmaceutical ingredients who did not previously respond to
FDA's specific requests for comments. In light of these requests, FDA
is reopening the comment period for an additional 30 days.

III. How To Submit Comments

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

    Dated: January 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1274 Filed 1-21-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 13 (Friday, January 20, 2012)]
[Notices]
[Pages 2963-2964]
[FR Doc No: 2012-1070]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC12-1-000]

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

AGENCY: Federal Energy Regulatory Commission.

ACTION: Comment request.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory
Commission (Commission or FERC) is submitting the information
collection FERC-725F, ``Mandatory Reliability Standards for Nuclear
Plant Interface Coordination'', to the Office of Management and Budget
(OMB) for review of the information collection requirements. Any
interested person may file comments directly with OMB and should
address a copy of those comments to the Commission as explained below.
The Commission issued a Notice in the Federal Register (76 FR 67158,
10/31/2011) requesting public comments. FERC received no comments on
the FERC-725F and is making this notation in its submittal to OMB.

DATES: Comments on the collection of information are due by February
21, 2012.

ADDRESSES: Comments filed with OMB, identified by the OMB Control No.
1902-0249, should be sent via email to the Office of Information and
Regulatory Affairs<EMAIL_ADDRESS>Attention: Federal Energy
Regulatory Commission Desk Officer. The Desk Officer may also be
reached via telephone at<PHONE_NUMBER>.
    A copy of the comments should also be sent to the Federal Energy
Regulatory Commission, identified by the Docket No. IC12-1-000, by
either of the following methods:
    eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
    Mail/Hand Delivery/Courier: Federal Energy Regulatory Commission,
Secretary of the Commission, 888 First Street, NE., Washington, DC
20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by e-mail at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

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

SUPPLEMENTARY INFORMATION:
    Title: FERC-725F Mandatory Reliability Standards for Nuclear Plant
Interface Coordination
    OMB Control No.: 1902-0249
    Type of Request: Three-year extension of the FERC-725F information
collection requirements with no changes to the reporting requirements.
    Abstract: The Commission requires the information collected by the
FERC-725F to implement the statutory provisions of section 215 of the
Federal Power Act (FPA) (16 U.S.C. 824o). On August 8, 2005, the
Electricity Modernization Act of 2005, which is Title XII, Subtitle A,
of the Energy Policy Act of 2005 (EPAct 2005), was enacted into law.\1\
EPAct 2005 added a new section 215 to the FPA, which required a
Commission-certified Electric Reliability Organization (ERO) to develop
mandatory and enforceable Reliability Standards, which are subject to
Commission review and approval. Once approved, the Reliability
Standards may be enforced by the ERO subject to Commission oversight,
or the Commission can independently enforce Reliability Standards.\2\
---------------------------------------------------------------------------

    \1\ Energy Policy Act of 2005, Public Law 109-58, Title XII,
Subtitle A, 119 Stat. 594, 941 (2005), 16 U.S.C. 824o.
    \2\ 16 U.S.C. 824o(e)(3).
---------------------------------------------------------------------------

    On February 3, 2006, the Commission issued Order No. 672,
implementing section 215 of the FPA.\3\ Pursuant to Order No. 672, the
Commission certified one organization, North American Electric
Reliability Corporation (NERC), as the ERO. The Reliability Standards
developed by the ERO and approved by the Commission apply to users,
owners and operators of the Bulk-Power System as set forth in each
Reliability Standard.
---------------------------------------------------------------------------

    \3\ Rules Concerning Certification of the Electric Reliability
Organization; and Procedures for the Establishment, Approval, and
Enforcement of Electric Reliability Standards, Order No. 672, FERC
Stats. & Regs. ] 31,204, order on reh'g, Order No. 672-A, FERC
Stats. & Regs. ] 31,212 (2006).
---------------------------------------------------------------------------

    On November 19, 2007, NERC filed its petition for Commission
approval of the Nuclear Plant Interface Coordination Reliability
Standard, designated NUC-001-1. In Order No. 716, issued October 16,
2008, the Commission approved the standard while also directing certain

revisions.\4\ Revised Reliability Standard, NUC-001-2, was filed with
the Commission by NERC in August 2009 and subsequently approved by the
Commission January 21, 2010.\5\
---------------------------------------------------------------------------

    \4\ Mandatory Reliability Standard for Nuclear Plant Interface
Coordination, Order No. 716, 125 FERC ] 61,065, at P 189 & n.90
(2008), order on reh'g, Order No. 716-A, 126 FERC ] 61,122 (2009).
    \5\ North American Electric Reliability Corporation, 130 FERC ]
61,051 (2010). When the revised Reliability Standard was approved
the Commission did not go to OMB for approval. It is assumed that
the changes made did not substantively affect the information
collection and therefore a formal submission to OMB was not needed.
---------------------------------------------------------------------------

    The purpose of Reliability Standard NUC-001-2 is to require
``coordination between nuclear plant generator operators and
transmission entities for the purpose of ensuring nuclear plant safe
operation and shutdown.'' \6\ The Nuclear Reliability Standard applies
to nuclear plant generator operators (generally nuclear power plant
owners and operators, including licensees) and ``transmission
entities,'' defined in the Reliability Standard as including a nuclear
plant's suppliers of off-site power and related transmission and
distribution services. To account for the variations in nuclear plant
design and grid interconnection characteristics, the Reliability
Standard defines transmission entities as ``all entities that are
responsible for providing services related to Nuclear Plant Interface
Requirements (NPIRs),'' and lists eleven types of functional entities
(heretofore described as ``transmission entities'') that could provide
services related to NPIRs.\7\
---------------------------------------------------------------------------

    \6\ See Reliability Standard NUC-001-2 at http://www.nerc.com/files/NUC-001-2.pdf.
    \7\ The list of functional entities consists of transmission
operators, transmission owners, transmission planners, transmission
service providers, balancing authorities, reliability coordinators,
planning authorities, distribution providers, load-serving entities,
generator owners and generator operators.
---------------------------------------------------------------------------

    Reliability Standard NUC-001-2 requires a nuclear power plant
operator and its suppliers of back-up power and related transmission
and distribution services to coordinate concerning nuclear licensing
requirements for safe nuclear plant operation and shutdown and system
operating limits. Information collection requirements include
establishing and maintaining interface agreements, including record
retention requirements.
    Type of Respondents: e.g. nuclear operators, nuclear plants,
transmission entities
    Estimate of Annual Burden: \8\ The Commission estimates the Public
Reporting Burden for this information collection as:
---------------------------------------------------------------------------

    \8\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, reference 5 Code of Federal Regulations 1320.3.

----------------------------------------------------------------------------------------------------------------
                                      Number of           Number of        Average burden
 FERC data collection FERC-725F      respondents          responses          hours per       Total annual burden
  (OMB Control No. 1902-0249)         annually           (Documents)          response              hours
                                 (1)...............  (2)...............  (3)..............  (1)*(2)*(3)
----------------------------------------------------------------------------------------------------------------
New agreements.................  10 nuclear          1.................  Reporting: 1,080.  Reporting: 32,400
                                  operators + 20
                                  transmission
                                  entities.
                                                                         Recordkeeping:     Recordkeeping: 3,240
                                                                          108.
----------------------------------------------------------------------------------------------------------------
Modifications to agreements....  65 nuclear plants   2.................  Reporting: 67      Reporting: 26,000
                                  + 130                                   (rounded).
                                  transmission
                                  entities \9\.
                                 ..................  ..................  Recordkeeping: 7   Recordkeeping: 2,600
                                                                          (rounded).
                                --------------------------------------------------------------------------------
    Total......................  Not applicable      Not applicable....  Not applicable...  64,240
                                  (see text for
                                  discussion).
----------------------------------------------------------------------------------------------------------------

    The Commission estimates the total annual cost burden to
respondents as:
---------------------------------------------------------------------------

    \9\ This figure of 130 transmission entities is based on the
assumption that each agreement will be between 1 nuclear plant and 2
transmission entities (65 times 2 = 130). However, there is some
double counting in this figure because some transmission entities
may be party to multiple agreements with multiple nuclear plants.
The double counting does not affect the burden estimate and the
correct number of unique respondents will be reported to OMB.
---------------------------------------------------------------------------

     58,400 Reporting hours x $120/hour \10\ = $7,008,000.
---------------------------------------------------------------------------

    \10\ The $120/hour figure is a combined average of legal,
technical and administrative staff.
---------------------------------------------------------------------------

     5,840 Recordkeeping hours x $28/hour \11\ = $163,520 (plus
the record storage cost: 143 entities x $15.25/year per entity \12\ =
$2,181 (rounded)
---------------------------------------------------------------------------

    \11\ The $28/hour figure is based on a FERC staff study that
included estimating public utility recordkeeping costs.
    \12\ This is based on the estimated cost to service and store 1
GB of data (based on the aggregated cost of an IBM advanced data
protection server).
---------------------------------------------------------------------------

    Total annual cost burden to respondents = $7,173,701.
    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: January 13, 2012.
Kimberly D. Bose,
Secretary.
 [FR Doc. 2012-1070 Filed 1-19-12; 8:45 am]
BILLING CODE 6717-01-P


<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  >

<EPA Registration Division contact: [P.V. Shah,<PHONE_NUMBER>]>

<INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert “NA-Remove” and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., “[insert company name],” with the information specific to your action.>

<TEMPLATE:>

<[Dow AgroSciences, LLC]>

<8E7504>

<	EPA has received a pesticide petition (8E7504) from [Dow AgroSciences, LLC], [9330 Zionsville Rd, Indianapolis, IN, 46268] proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.>

<	 to establish an exemption from the requirement of a tolerance for>

<	[2-Propanol, 1,1’,1”-nitrilotris-(TIPA) under 40 CFR 180.910 when used as an inert ingredient for use as a neutralizer in a pesticide formulation].  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.>

<A. Residue Chemistry [This information is not available, nor required for the establishment of a tolerance exemption.]

>

<	1. Plant metabolism. [omit -per above, not needed.]>

<	2. Analytical method. [omit -per above, not needed.]>

<	3. Magnitude of residues. [omit -per above, not needed.]>

<B. Toxicological Profile [TIPA belongs to the general class of alkanolamines which typically exhibit low acute oral and dermal toxicity, but also display eye and skin irritancy.  EPA has already reviewed and granted 40 CFR 180.920 tolerance exemptions for other similar alkanolamines.]>

<	1. Acute toxicity.  [TIPA exhibits low acute toxicity; the acute oral LD50 is 5994 mg/kg/day and the acute dermal value is >5000 mg/kg/day.  TIPA is a known eye irritant and can cause moderate skin irritation.  Based on the acute LD50 values, no acute reference dose is needed for risk assessment.]>

<	2. Genotoxicity. [For TIPA, the results of three different in vitro mutagenicity tests were negative.]>

<	3. Reproductive and developmental toxicity. [In a 1-generation reproductive toxicity test with TIPA in rats, no adverse clinical, histological, or reproductive effects were noted, and the NOAEL was reported to be >609 mg/kg/day for males and 700 mg/kg/day for females, the highest dose levels tested.  In addition, repeated-dose toxicity studies on TIPA have failed to identify any effects in the gonads of male or female rats or dogs.

To assess the developmental toxicity for TIPA, surrogate data is available from the related diisopropanolamine analogue, DIPA.  An OECD 414 study for developmental toxicity with DIPA found no treatment-related effects on the incidence of fetal alterations at dose levels up to 1000 mg/kg/day.  The reported NOEL for maternal and developmental toxicity was 1000 mg/kg/day.

Given the low developmental toxicity and the lack of developmental effects, an FQPA Safety Factor of 1X is proposed for TIPA.]>

<	4. Subchronic toxicity. [For TIPA, a 90-day repeat dose study in dogs yielded at NOAEL of >272 mg/kg/day based on the 7500 ppm highest study dose.  No treatment related effects were noted for any test group.  This repeat dose study is used to propose the chronic reference dose for risk assessment.]>

<	5. Chronic toxicity. [A 2-yr study in rats with 2% TIPA revealed no evidence of increased liver foci.  Together with the negative genotoxicity studies for TIPA, these data support the conclusion that the material is not likely to be carcinogenic.  TIPA is not listed by ACGIH, IARC, NTP, or CA Prop 65.]>

<	6. Animal metabolism. [Orally administered TIPA was rapidly and extensively absorbed; a minimum of 83%.  Virtually all was rapidly excreted primarily as unchanged TIPA in the urine.]>

<	7. Metabolite toxicology. [This information is not available, nor required for the establishment of a tolerance exemption.]>

<	8. Endocrine disruption. [TIPA is not compatible with direct endocrine activity on the basis of structural activity relationships.  In addition, there is no histopathological or behavioral evidence of an endocrine function in any toxicity evaluations of TIPA or its close analogue (DIPA) conducted in laboratory animals.  The TIPA one-generation toxicity study conducted in rats included pre-mating, mating period, gestation, lactational and post-lactation dosing.]>

<C. Aggregate Exposure >

<	1. Dietary exposure. [Based on the low acute toxicity, no acute reference dose is established.  Based on the 90-day studies for TIPA the following is proposed: chronic oral – NOAEL of 272 mg/kg bw/day with UF=100 for a cRfD of 2.7 mg/kg/day = cPAD (chronic population adjusted dose).]>

erts within the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID™, Version 2.14).  Exposure from food, animal commodities and drinking water are included.  Children 1-2 years old are found to be the most exposed subpopulation with an estimated exposure of 0.425 mg/kg/day for drinking water and food from EPA IDEEM calculations.

The dietary (food plus drinking water) exposures for TIPA are expressed as a percentage of the proposed cPAD for the general US population and children 1-2 years old.  Based on I-DEEM screening level calculations, the chronic dietary exposures are estimated to be 1.4% of the cPAD for the general U.S. population and <5% of the cPAD for children 1-2 years old.]>

<	ii. Drinking water. [Drinking water estimates have been included in the I-DEEM model.]>

<	2. Non-dietary exposure. [No exposure to TIPA is expected through residential herbicidal products.  Some exposure to TIPA from non-pesticide uses may occur via coatings of paper, personal care products, lubricants, pigments, or plastics.  Comparison of the predicted exposure from IDEEM to the NOAEL value of 272 mg/kg/day for TIPA results in an MOE of >2000 for children 1-2 years of age.  MOE values for other subpopulations are higher.  Because the MOE values from the dietary assessment range from >2000 to over 10,000, the large additional margins of safety above 100 is deemed adequate to cover any other aggregate exposure from non-dietary or post harvest uses.]

>

<D. Cumulative Effects>

<	[For the purposes of this tolerance action, it is not assumed that TIPA has a common mechanism of toxicity with other substances.]>

<E. Safety Determination>

<	1. U.S. population. [For the general population, the estimated exposure is 1.4% of the cRfD. A reasonable certainty of no harm has been established for the proposed use of TIPA as an inert in pesticide formulations for the general population.]>

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 as well as registration decisions for TIPA-herbicide salts which indicate no developmental or reproduction concerns.  Estimated exposure for children represents <5 % of the proposed cPAD; a reasonable certainty of no harm has been established for children.]>

<F. International Tolerances>

<	[Omit – not applicable.  There are no known tolerances.]>

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