[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)]
[Notices]
[Pages 65660-65661]
[FR Doc No: 2016-22944]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0881]

Self-Identification of Generic Drug Facilities, Sites, and
Organizations; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Self-
Identification of Generic Drug Facilities, Sites, and Organizations.''
On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA)
was signed into law by the President. GDUFA, designed to speed the
delivery of safe and effective generic drugs to the public and reduce
costs to industry, requires that generic drug facilities, sites, and
organizations around the world provide identification information
annually to FDA. This guidance is intended to assist industry to meet
the self-identification requirement. It explains who is required to
self-identify, what information must be requested, how the information
should be submitted to FDA, and what the penalty is for failure to
self-identify.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

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-2012-D-0881 for ``Self-Identification of Generic Drug Facilities,
Sites, and Organizations.'' 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.
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Andrew LeBoeuf, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Self-Identification of Generic Drug Facilities, Sites, and
Organizations.'' The guidance announced in this notice finalizes the
draft guidance of the same name announced in the Federal Register of
August 27, 2012 (77 FR 51811). Compared to the draft guidance, the
final guidance clarifies various matters, including that the self-
identification requirements have been implemented, and simplifies the
instructions for electronic submission of self-identification
information. FDA received one comment on the draft guidance, which was
considered as the guidance was finalized.
    On July 9, 2012, GDUFA (Pub. L. 112-144, Title III) was signed into
law by the President. GDUFA is designed to speed the delivery of safe
and effective generic drugs to the public and reduce costs to industry.
GDUFA enables FDA to assess user fees to support critical and
measurable enhancements to FDA's generic drugs program. GDUFA will also
significantly improve global supply chain transparency by requiring
owners of facilities producing generic drug products, active
pharmaceutical ingredients (API), and certain other sites and
organizations that support the manufacture or approval of these
products to electronically self-identify with FDA and update that
information annually.
    Self-identification is required for two purposes. First, it is
necessary to determine the universe of facilities required to pay user
fees. Second, self-identification is a central component of an effort
to promote global supply chain transparency. The information provided
through self-identification enables quick, accurate, and reliable
surveillance of generic drugs and facilitates inspections and
compliance.
    Most facilities that self-identify are required to pay an annual
facility user fee. These include facilities manufacturing, or intending
to manufacture, API of human generic drugs and/or finished dosage form
(FDF) human generic drugs. Other facilities, sites, and organizations
must self-identify, but are not required to pay the annual facility
user fee. These include facilities that solely manufacture positron
emission tomography drugs, or sites and organizations that only perform
testing, repackaging, or relabeling operations. Please note that while
re-packagers are not required to pay user fees, packagers are, in most
cases, FDF manufacturers and subject to facility fees.
    A separate system for the electronic self-identification of generic
industry facilities, sites, and organizations was established for
GDUFA. Entities required to register and list (under section 510 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) or section 351 of
the Public Health Service Act (42 U.S.C. 262)), and those required to
self-identify under GDUFA, submit information separately to the
respective systems. Each system populates its own database to meet
unique requirements and deadlines. The new GDUFA system uses the same
platform and technical standards already familiar to manufacturers
required to register and list.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Self-Identification of Generic Drug
Facilities, Sites, and Organizations.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: September 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22944 Filed 9-22-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 227 (Monday, November 25, 2019)]
[Proposed Rules]
[Pages 64795-64797]
[FR Doc No: 2019-25293]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0799; Airspace Docket No. 19-AGL-13]
RIN 2120-AA66

Proposed Amendment of VHF Omnidirectional Range (VOR) Federal
Airway V-71 and Area Navigation Route T-285 Due to the Decommissioning
of the Winner, SD, VOR

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend VHF Omnidirectional Range (VOR)
Federal airway V-71 and area navigation (RNAV) route T-285. The FAA is
proposing this action due to the planned decommissioning of the Winner,
SD (ISD), VOR navigation aid (NAVAID). The Winner VOR is being
decommissioned in support of the FAA's VOR Minimum Operational Network
(MON) program.

DATES: Comments must be received on or before January 9, 2020.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1
(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2019-0799; Airspace Docket No. 19-AGL-13 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order 7400.11D, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email:
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Policy Group,
Office of Airspace Services, Federal

Aviation Administration, 800 Independence Avenue SW, Washington, DC
20591; telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would modify the National Airspace System as necessary
to preserve the safe and efficient flow of air traffic.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2019-0799; Airspace Docket No. 19-AGL-13) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2019-0799; Airspace Docket No. 19-AGL-13.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Operations Support Group, Central
Service Center, Federal Aviation Administration, 10101 Hillwood Blvd.,
Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11D, Airspace
Designations and Reporting Points, dated August 8, 2019, and effective
September 15, 2019. FAA Order 7400.11D is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11D lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

Background

    The FAA is planning to decommission the Winner, SD (ISD), VOR in
May 2020. The Winner VOR was one of the candidate VORs identified for
discontinuance by the FAA's VOR MON program and listed in the Final
policy statement notice, ``Provision of Navigation Services for the
Next Generation Air Transportation System (NextGen) Transition to
Performance-Based Navigation (PBN) (Plan for Establishing a VOR Minimum
Operational Network),'' published in the Federal Register of July 26,
2016 (81 FR 48694), Docket No. FAA-2011-1082. The ATS routes effected
by the Winner VOR decommissioning are VOR Federal airway V-71 and RNAV
route T-285.
    With the planned decommissioning of the Winner VOR, the remaining
ground-based NAVAID coverage in the area is insufficient to enable the
continuity of V-71 within the affected area. As such, the proposed
modification to V-71 would result in a gap in the airway with the
airway segments between the O'Neill, NE, VOR/Tactical Air Navigation
(VORTAC) and the Pierre, SD, VORTAC NAVAIDs being removed.
    To overcome the removal of the V-71 airway segments, the FAA plans
to retain the current fixes located along those airway segments to
assist pilots and air traffic controllers already familiar with them,
for point-to-point navigation or radar vector purposes. Additionally, a
new waypoint (LESNR) is being established overhead the Winner VOR
location (within 60 feet) to retain that route point for navigation and
radar vector purposes as well.
    Further, the FAA proposes to retain T-285 as it is charted today by
replacing the Winner VOR route point with the new LESNR waypoint. The
minor adjustment of the LESNR waypoint overhead the Winner VOR location
(within 60 feet) is expected to be transparent to pilots flying the
RNAV route and not change the charted depiction of T-285.
    Instrument flight rules (IFR) traffic could use the retained T-285
RNAV route, file point-to-point using the fixes and new LESNR waypoint
that will remain in place, or receive air traffic control (ATC) radar
vectors to continue operating through the affected area. Visual flight
rules (VFR) pilots who elect to navigate via the airways through the
affected area could also take advantage of the air traffic services
previously listed.
    A number of minor editorial corrections to the T-285 legal
description are also proposed to comply with RNAV route description
policy guidance. The editorial corrections do not change the route's
structure, operational use, or charted depiction.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to amend VOR Federal airway V-71 and RNAV
route T-285 due to the planned decommissioning of the Winner, SD, VOR.
The proposed air traffic service (ATS) route actions are described
below.
    V-71: V-71 currently extends between the Fighting Tiger, LA, VORTAC
and the Williston, ND, VOR/Distance Measuring Equipment (VOR/DME)
NAVAIDs. The FAA proposes to remove the airway segment between the
O'Neill, NE, VORTAC and the Pierre, SD, VORTAC. The unaffected portions
of the existing airway would remain as charted.
    T-285: T-285 currently extends between the North Platte, NE, VORTAC

and the Huron, SD, VORTAC NAVAIDs. The FAA proposes to retain the route
by replacing the Winner, SD, VOR route point with the new LESNR
waypoint being established overhead the Winner VOR location.
Additionally, the Rapid City VORTAC ``RAP'' identifier and Huron VORTAC
``HON'' identifier are added to the first line of the route description
and the geographic coordinates of each route point are updated to be
expressed in degrees, minutes, seconds, and hundredths of a second. The
existing route would remain as charted.
    The NAVAID radials listed in the V-71 airway description below are
unchanged and stated in True degrees.
    VOR Federal airways are published in paragraph 6010(a) and RNAV T-
routes are published in paragraph 6011 of FAA Order 7400.11D dated
August 8, 2019, and effective September 15, 2019, which is incorporated
by reference in 14 CFR 71.1. The ATS routes listed in this document
would be subsequently published in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-71

    From Fighting Tiger, LA; Natchez, MS; Monroe, LA; El Dorado, AR;
Hot Springs, AR; INT Hot Springs 358[deg] and Harrison, AR, 176[deg]
radials; Harrison; Springfield, MO; Butler, MO; Topeka, KS; Pawnee
City, NE; INT Pawnee City 334[deg] and Lincoln, NE, 146[deg]
radials; Lincoln; Columbus, NE; to O'Neill, NE. From Pierre, SD;
Bismarck, ND; to Williston, ND.
* * * * *

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-285 North Platte, NE (LBF) to Huron, SD (HON)

North Platte, NE (LBF)                         VORTAC                        (Lat. 41[deg]02'55.34'' N, long. 100[deg]44'49.55'' W)
Thedford, NE (TDD)                             VOR/DME                       (Lat. 41[deg]58'53.99'' N, long. 100[deg]43'08.55'' W)
MARSS, NE                                      Fix                           (Lat. 42[deg]27'48.92'' N, long. 100[deg]36'15.32'' W)
Valentine, NE (VTN)                            NDB                           (Lat. 42[deg]51'41.85'' N, long. 100[deg]32'58.73'' W)
LKOTA, SD                                      WP                            (Lat. 43[deg]15'28.00'' N, long. 100[deg]03'14.00'' W)
LESNR, SD                                      WP                            (Lat. 43[deg]29'16.06'' N, long. 99[deg]45'41.55'' W)
Huron, SD (HON)                                VORTAC                        (Lat. 44[deg]26'24.30'' N, long. 98[deg]18'39.89'' W)

* * * * *

    Issued in Washington, DC, on November 18, 2019.
Rodger A. Dean Jr.,
Acting Manager, Airspace Policy Group.
[FR Doc. 2019-25293 Filed 11-22-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 157 (Wednesday, August 18, 2021)]
[Notices]
[Pages 46236-46237]
[FR Doc No: 2021-17700]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3442-029]

City of Nashua, New Hampshire; Notice of Application Tendered for
Filing With the Commission and Soliciting Additional Study Requests and
Establishing Procedural Schedule for Relicensing and a Deadline for
Submission of Final Amendments

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Subsequent License.
    b. Project No.: 3442-029.
    c. Date Filed: July 30, 2021.
    d. Applicant: City of Nashua (the City).
    e. Name of Project: Mine Falls Hydroelectric Project.
    f. Location: The existing project is located on the Nashua River in
Hillsborough County, New Hampshire. The project does not affect federal
lands.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: James W. Donchess, Mayor, City of Nashua, 229
Main Street, P.O. Box 2019, Nashua, NH 03060; Telephone<PHONE_NUMBER>.
    i. FERC Contact: Khatoon Melick,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item l below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See, 94 FERC ]
61,076 (2001).
    k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or person believes
that an additional scientific study should be conducted in order to
form an adequate factual basis for a complete analysis of the
application on its merit, the resource agency, Indian Tribe, or person
must file a request for a study with the Commission not later than 60
days from the date of filing of the application, and serve a copy of
the request on the applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: September 28, 2021. The Commission strongly
encourages electronic filing. Please file additional study requests and
requests for cooperating agency status using the Commission's eFiling
system at https://ferconline.ferc.gov/FERCOnline.aspx. For assistance,
please contact FERC Online Support at<EMAIL_ADDRESS>(866)
208-3676 (toll free), or<PHONE_NUMBER> (TTY). In lieu of electronic
filing, you may submit a paper copy. Submissions sent via the U.S.
Postal Service must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE, Room 1A,
Washington, DC 20426. Submissions sent via any other carrier must be
addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. All
filings must clearly identify the project name and docket number on the
first page: Mine Falls Hydroelectric Project (P-3442-029).
    m. The application is not ready for environmental analysis at this
time.
    n. Project Description: The existing Mine Falls Project consists
of: (1) A 242-acre impoundment with a normal storage volume of 1,970
acre-feet and a normal headpond elevation of 158.76 ft (NAVD 88); (2) a
rock filled concrete cap, variable in height dam with an approximately
132-foot-long spillway at a permanent crest elevation of 154.66 feet,
and nominal 4.0-foot-high wooden flashboards maintaining a normal
headpond elevation of 158.76 feet; (3) a 22-foot-wide and 170-foot-long
reinforced concrete power canal located between the right bank of the
Nashua river and the single flood sluice gate; (4) two 12.5-foot-long
wooden stoplog bays located immediately upstream of the intake to the
right of the concrete capped spillway (viewed facing downstream) with a
10-foot-wide gate and a short spillway section above the gate; (5) a
40-foot-wide, 20-foot-high intake structure with steel trashrack with
two square-to-round transition openings that feed the two penstocks
that terminate at the two turbines; (6) two 64-foot-long, 104-inch-
diameter steel penstocks between the intake and turbine units; (7) a
44-foot-long, 44-foot-wide multi-level reinforced concrete powerhouse
containing two 1,500 kilowatt turbine-generator units; (8) an
approximately 22-foot-wide, 1,100-foot-long tailrace that is a channel
cut into the Nashua river bedrock downstream of the powerhouse that
returns water back into the Nashua river; (9) a 278-foot-long bypass
reach extending from the spillway crest and stoplog bays to the
downstream of the powerhouse at the tailrace, bypassing 20 cubic feet
per second (cfs) of water for environmental flows; (10) an upstream
fish passage; (11) a 610-foot-long, 34.5-kilovolt underground
transmission line connects the generator transformer to the
interconnect point; and (12) appurtenant facilities. The estimated
gross head of the project is 38 feet. The powerplant has a maximum
nameplate capacity of 3 MW. The project generates an annual average of
12,563 megawatt-hours.
    The City proposes to continue to operate the project in a run-of-
river mode with no storage or flood control capacity. The project
operates within a flow range of 180 cfs (150 cfs minimum hydraulic
capacity to start a single

turbine, plus 20 cfs minimum bypass release at the dam and an
additional 10 cfs flow routed through the Mill Pond gatehouse to the
Mill Pond and canal) and 1,100 cfs (maximum hydraulic capacity of the
plant--two turbines combined) or a river flow of 1,130 cfs. Any flow
above the capacity of the turbines plus minimum bypass flow and Mill
pond diversion is spilled over the dam spillway and through the
overflow section of the flood sluice gate.
    o. In addition to publishing the full text of this notice in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this notice, as well
as other documents in the proceeding (e.g., license application) via
the internet through the Commission's Home Page (http://www.ferc.gov)
using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document (P-
3442). At this time, the Commission has suspended access to the
Commission's Public Reference Room due to the proclamation declaring a
National Emergency concerning the Novel Coronavirus Disease (COVID-19)
issued by the President on March 13, 2020. For assistance, contact FERC
at<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or
(202) 502-8659 (TTY).
    You may also register online at https://ferconline.ferc.gov/FERCOnline.aspx to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    p. Procedural Schedule: The application will be processed according
to the following preliminary Hydro Licensing Schedule. Revisions to the
schedule may be made as appropriate.

------------------------------------------------------------------------
                 Milestone                           Target date
------------------------------------------------------------------------
Issue Deficiency Letter...................  September 2021.
Request Additional Information............  September 2021.
Issue Notice of Acceptance................  January 2022.
Issue Scoping Document 1 for Comments.....  January 2022.
Comments on Scoping Document 1 Due........  March 2022.
Issue Scoping Document 2..................  April 2022.
Issue Notice of Ready for Environmental     April 2022.
 Analysis.
------------------------------------------------------------------------

    q. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

    Dated: August 12, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-17700 Filed 8-17-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 83 (Tuesday, April 30, 2019)]
[Notices]
[Pages 18280-18281]
[FR Doc No: 2019-08642]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2012-0699; FRL-9993-05-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Primary Magnesium Refining
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NESHAP for Primary Magnesium
Refining (EPA ICR Number 2098.08, OMB Control Number 2060-0536) to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through June 30,
2019. Public comments were previously requested via the Federal
Register on May 30, 2018 during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An agency may not conduct or sponsor and a
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before May 30, 2019.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2012-0699, to (1) EPA online using www.regulations.gov (our
preferred method), by email to [email protected], or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460, and (2) OMB via email to
[email protected]. Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for the regulations published at 40 CFR part 63,
subpart TTTTT were proposed on January 22, 2003, promulgated on October
10, 2003, and

amended on April 20, 2006. These regulations apply to existing and new
facilities that perform primary magnesium refining where the total
hazardous air pollutants (HAPs) emitted are greater than, or equal to,
10 tons per year for each HAP, or where the total HAPs emitted are
greater than, or equal to, 25 tons per year of any combination of HAPs.
New facilities include those that commenced construction or
reconstruction after the date of proposal. This information is being
collected to assure compliance with 40 CFR part 63, subpart TTTTT.
    In general, all NESHAP standards require initial notifications,
performance tests, and periodic reports by the owners/operators of the
affected facilities. They are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. These notifications, reports, and
records are essential in determining compliance, and are required of
all affected facilities subject to NESHAP.
    Form Numbers: None.
    Respondents/affected entities: Primary magnesium refining
facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63
Subpart TTTTT).
    Estimated number of respondents: 1 (total).
    Frequency of response: Initially, occasionally, and semiannually.
    Total estimated burden: 611 hours (per year). Burden is defined at
5 CFR 1320.3(b).
    Total estimated cost: $70,900 (per year), includes $1,200
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is no change in the labor hours or
O&M cost in this ICR compared to the previous ICR. This is due to two
considerations. First, the regulations have not changed over the past
three years and are not anticipated to change over the next three
years. Secondly, the growth rate for the industry is very low, negative
or non-existent, so there is no significant change in the overall
burden.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2019-08642 Filed 4-29-19; 8:45 am]
 BILLING CODE 6560-50-P