[Federal Register Volume 82, Number 56 (Friday, March 24, 2017)]
[Notices]
[Page 15098]
[FR Doc No: 2017-05886]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2017-02]

Petition for Exemption; Summary of Petition Received; NaturChem
Inc.

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14 of the Code of Federal
Regulations. The purpose of this notice is to improve the public's
awareness of, and participation in, the FAA's exemption process.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before April 13, 2017.

ADDRESSES: Send comments identified by docket number FAA-2016-9551
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jake Troutman,<PHONE_NUMBER>, 800
Independence Avenue SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on March 17, 2017.
Lirio Liu,
Director, Office of Rulemaking.

Petition For Exemption

    Docket No.: FAA-2016-9551.
    Petitioner: NaturChem Inc.
    Section(s) of 14 CFR Affected: Parts 21, 27, and 137, and 14 CFR
45.23(b), 61.113(a) and (b), 91.7(a), 91.9(b)(2), 91.103, 91.109,
91.119, 91.121, 91.151(b), 91.203(a) and (b), 91.405(a), 91.407(a)(1),
91.409(a)(2), 91.417(a) and (b), and 91.1501.
    Description of Relief Sought: The petitioner is requesting an
exemption for the purpose of operating its octocopter, the Stark Hx8
(dry weight of 69 pounds), to provide commercial agricultural-related
services.

[FR Doc. 2017-05886 Filed 3-23-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: June 28, 2010 (Volume 75, Number 123)]
[Proposed Rules]
[Page 36583-36584]
[DOCID:fr28jn10-19]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0267; Airspace Docket No. 10-AGL-5]

Proposed Amendment of Class E Airspace; Youngstown, OH

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace at Youngstown,
OH, adding additional controlled airspace necessary to accommodate new
Standard Instrument Approach Procedures (SIAPs) at Youngstown Elser
Metro Airport, Youngstown, OH. The FAA is taking this action to enhance
the safety and management of Instrument Flight Rules (IFR) operations
at the airport.

DATES: Comments must be received on or before August 12, 2010.

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 20590-0001. You
must identify the docket number FAA-2010-0267/Airspace Docket No. 10-
AGL-5, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1-800-647-5527), is on the ground floor of the building at
the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: 817-321-
7716.

SUPPLEMENTARY INFORMATION:

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 and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2010-0267/
Airspace Docket No. 10-AGL-5.'' The postcard will be date/time stamped
and returned to the commenter.

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 http://
www.faa.gov/airports_airtraffic/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 a.m. and 5 p.m., Monday through Friday, except Federal holidays. An
informal docket may also be examined during normal business hours at
the office of the Central Service Center, 2601 Meacham Blvd., Fort
Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by adding additional Class E airspace extending
upward from 700 feet above the surface for SIAPs at Youngstown Elser
Metro Airport, Youngstown, OH. Controlled airspace is needed for the
safety and management of IFR operations at the airport.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9T, dated August 27, 2009, and effective September 15, 2009, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    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 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 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.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, 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
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 add additional controlled airspace at Youngstown Elser
Metro Airport, Youngstown, OH.

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9T, Airspace Designations and Reporting Points, signed August 27,
2009, and effective September 15, 2009, is amended as follows:

Paragraph 6005 Class E Airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AGL OH E5 Youngstown Elser Metro Airport, OH [Amended]

Youngstown Elser Metro Airport, OH
    (Lat. 40[deg]57'42'' N., long. 80[deg]40'38'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Youngstown Elser Metro Airport, and
within 4 miles each side of the 108[deg] bearing from the airport
extending from the 6.4-mile radius to 8.8 miles east of the airport,
and within 4 miles each side of the 091[deg] bearing from the
airport extending from the 6.4-mile radius to 9.5 miles east of the
airport, and within 4 miles each side of the 270[deg] bearing from
the airport extending from the 6.4-mile radius to 10.9 miles west of
the airport.

    Issued in Fort Worth, TX, on June 16, 2010.
Anthony D. Roetzel,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2010-15647 Filed 6-25-10; 8:45 am]
BILLING CODE 4901-13-P


[Federal Register Volume 86, Number 83 (Monday, May 3, 2021)]
[Notices]
[Pages 23410-23411]
[FR Doc No: 2021-09150]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4509-DR; Docket ID FEMA-2021-0001]

North Dakota; Amendment No. 4 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of North Dakota (FEMA-4509-DR), dated April 1, 2020, and
related determinations.

DATES: This amendment was issued March 11, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of North Dakota is hereby amended to include Individual
Assistance limited to COVID-19 Funeral Assistance under Other Needs
Assistance for those areas determined to have been adversely affected
by the event declared a major disaster by the President in his
declaration of April 1, 2020.

    Individual Assistance limited to COVID-19 Funeral Assistance
under Other Needs Assistance for all areas in the State of North
Dakota (already designated for Individual Assistance, limited to the
Crisis Counseling

Program and emergency protective measures [Category B] not
authorized under other Federal statutes, including direct Federal
assistance).

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-09150 Filed 4-30-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: June 30, 2008 (Volume 73, Number 126)]
[Notices]
[Page 36883]
[DOCID:fr30jn08-88]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1763-DR]

Iowa; Amendment No. 9 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Iowa (FEMA-1763-DR), dated May 27, 2008, and related
determinations.

DATES: Effective Date: June 21, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Iowa is hereby amended to include the following areas
among those areas determined to have been adversely affected by the
catastrophe declared a major disaster by the President in his
declaration of May 27, 2008.

    Webster County for Individual Assistance (already designated for
Public Assistance.)
    Washington County for Public Assistance.
    Hardin, Harrison, Louisa, and Scott Counties for Public
Assistance (already designated for Individual Assistance.)

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidential Declared Disaster Areas; 97.049, Presidential Declared
Disaster Assistance--Disaster Housing Operations for Individuals and
Households; 97.050, Presidential Declared Disaster Assistance to
Individuals and Households--Other Needs; 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-14740 Filed 6-27-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Notices]
[Pages 64130-64131]
[FR Doc No: 2018-26975]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-P-1734]

Determination That IC-GREEN (Indocyanine Green for Injection), 10
Milligrams/Vial, 40 Milligrams/Vial, and 50 Milligrams/Vial Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that IC-GREEN (indocyanine green for injection), 10
milligrams (mg)/vial, 40 mg/vial, and 50 mg/vial, was not withdrawn
from sale for reasons of safety or effectiveness. This determination
will allow FDA to approve abbreviated new drug applications (ANDAs) for
indocyanine green for injection, 10 mg/vial, 40 mg/vial, and 50 mg/vial
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Heather A. Dorsey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products with Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn

from sale, but must be made prior to approving an ANDA that refers to
the listed drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve
an ANDA that does not refer to a listed drug.
    IC-GREEN (indocyanine green for injection), 10 mg/vial, 25 mg/vial,
40 mg/vial, and 50 mg/vial, is the subject of NDA 011525, held by
Akorn, Inc. IC-GREEN (indocyanine green for injection), 25 mg/vial and
50 mg/vial, became conditionally effective on February 2, 1959. IC-
GREEN (indocyanine green for injection), 10 mg/vial and 40 mg/vial,
became conditionally effective on March 20, 1967. NDA 011525 was
included in the Drug Efficacy Study Implementation review, (35 FR 12231
(July 30, 1970); 42 FR 31495 (June 21, 1977)) and the application was
approved on August 2, 1989. IC-GREEN (indocyanine green for injection)
is indicated for determining cardiac output, hepatic function, and
liver blood flow, and for ophthalmic angiography.
    IC-GREEN (indocyanine green for injection), 10 mg/vial, 40 mg/vial,
and 50 mg/vial, is currently listed in the ``Discontinued Drug Product
List'' section of the Orange Book.
    Foley & Lardner LLP submitted a citizen petition dated May 3, 2018
(Docket No. FDA-2018-P-1734), under 21 CFR 10.30, requesting that the
Agency determine whether IC-GREEN (indocyanine green for injection), 10
mg/vial, 40 mg/vial, and 50 mg/vial, was withdrawn from sale for
reasons of safety or effectiveness. In 1987, IC-GREEN (indocyanine
green for injection), 10 mg/vial and 40 mg/vial were discontinued from
marketing. In 1996, Akorn, Inc. discontinued marketing IC-GREEN
(indocyanine green for injection), 50mg/vial.
    After considering the citizen petition and reviewing Agency
records, and based on the information we have at this time, FDA has
determined under Sec.  314.161 that IC-GREEN (indocyanine green for
injection), 10 mg/vial, 40 mg/vial, and 50 mg/vial, was not withdrawn
for reasons of safety or effectiveness. The petitioner has identified
no data or other information suggesting that IC-GREEN (indocyanine
green for injection), 10 mg/vial, 40 mg/vial, and 50 mg/vial, was
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of IC-GREEN
(indocyanine green for injection), 10 mg/vial, 40 mg/vial, and 50 mg/
vial from sale. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
reviewed the available evidence and determined that these drug products
were not withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list IC-GREEN (indocyanine
green for injection), 10 mg/vial, 40 mg/vial, and 50 mg/vial, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to IC-GREEN (indocyanine
green for injection), 10 mg/vial, 40 mg/vial, and 50 mg/vial, may be
approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs. If FDA determines
that labeling for this drug product should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: December 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26975 Filed 12-12-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 199 (Tuesday, October 15, 2019)]
[Rules and Regulations]
[Page 55057]
[FR Doc No: 2019-22409]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2019-0795]

Safety Zone; New Orleans, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce a temporary safety zone between
mile marker (MM) 96.7 and MM 95.7 above Head of Passes, Lower
Mississippi River, LA. This action is necessary to provide for the
safety of life on these navigable waters near New Orleans, LA, during a
fireworks display. During the enforcement periods, the operator of any
vessel in the regulated area must comply with directions from the
Patrol Commander or any Official Patrol displaying a Coast Guard
ensign.

DATES: The regulations in 33 CFR 165.845 will be enforced from 9:15
p.m. through 10:15 p.m. on January 18, 2020.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
document, call or email Lieutenant Commander Corinne Plummer, Sector
New Orleans, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
regulation found in 33 CFR 165.845(a) for the Host-Global New Orleans
Fireworks Display event from 9:15 p.m. through 10:15 p.m. on January
18, 2020. This action is being taken to provide for the safety of life
on navigable waterways during this event, which will be located between
MM 96.7 and MM 95.7, above Head of Passes, Lower Mississippi River, LA.
During the enforcement periods, if you are the operator of a vessel in
the regulated area you must comply with directions from the Patrol
Commander or any Official Patrol displaying a Coast Guard ensign.
    In addition to the publication of this document in the Federal
Register, the Coast Guard plans to provide notification of this
enforcement period via a Marine Safety Information Bulletin and
Broadcast Notice to Mariners.

    Dated: October 7, 2019.
K.M. Luttrell,
Captain, U.S. Coast Guard, Captain of the Port Sector New Orleans.
[FR Doc. 2019-22409 Filed 10-11-19; 8:45 am]
 BILLING CODE 9110-04-P


----------------------------------------------------------------------------------------------------------------
\a\ Cost was provided by Antrim County in the application in $2012. Cost was indexed to $2015 using rates
  obtained from http://www.usinflationcalculator.com/inflation/current-inflation-rates.
\b\ Source: Energy Information Administration using rates obtained from Annual Energy Outlook 2014 at http://www.eia.gov/forecasts/aeo/index.cfm.

4.2 COMPARISON OF ALTERNATIVES

    Table 7 summarizes the installed capacity, annual generation, cost
of alternative power, estimated total project cost, and the difference
between the cost of alternative power and total project cost for each
of the action alternatives considered in this EA: (1) No-action; (2)
Antrim County's proposal; and (3) the staff-recommended alternative.

Table 7--Summary of Annual Cost of Alternative Power and Annual Project Cost for the Action Alternatives for the
                                               Elk Rapids Project
                            [Source: Antrim County, 2012; as modified by staff staff]
----------------------------------------------------------------------------------------------------------------
                                                                                Antrim          Staff-
                                                                     No-action       county's       recommended
                                                                    alternative      proposal       alternative
----------------------------------------------------------------------------------------------------------------
Installed capacity (MW).........................................           0.700           0.700           0.700
Annual generation (MWh).........................................           2,422           2,422           2,422
Annual cost of alternative power ($/MWh)........................           50.86           50.86           50.86
Annual project cost ($/MWh).....................................           71.66           71.77           72.06
Difference between the cost of alternative power and project             (20.80)         (20.91)         (21.20)
 cost ($/MWh) \a\...............................................
----------------------------------------------------------------------------------------------------------------
\a\ A number in parentheses denotes that the difference between the cost of alternative power and project cost
  is negative, thus the total project cost is greater than the cost of alternative power.

4.2.1 No-Action Alternative
    Under the no-action alternative, Antrim County would continue to
operate the project in its current mode of operation. The project would
have an installed capacity of 0.700 MW and generate an average of 2,422
MWh of electricity annually. The average annual cost of alternative
power would be $123,183 or about $50.86/MWh. The average annual project
cost would be $175,280 or $71.66/MWh. Overall, the project would
produce power at a cost that is $50,378 or $20.80/MWh, more than the
cost of alternative power.
4.2.2 Applicant's Proposal
    Under the applicant's proposal, the project would continue to
operate in its current mode with an installed capacity of 0.700 MW and
generate an average of 2,422 MWh of electricity annually. The average
annual cost of alternative power would be $123,183 or about $50.86/MWh.
The average annual project cost would be $173,827, or about $71.77/MWh.
Overall, the project would produce power at a cost that is $50,644 or
$20.91/MWh more than the cost of alternative power.
4.2.3 Staff Alternative
    Under the staff alternative, the project would have an installed
capacity of 0.700 MW, and generate an average of 2,422 MWh of
electricity annually. Table 8 shows the staff-recommended additions and
modifications to Antrim County's proposed environmental protection and
enhancement measures and the estimated cost of each.
    Based on an installed capacity of 0.700 MW and an average annual
generation of 2,422 MWh, the cost of alternative power would be
$123,183 or $50.86/MWh. The average annual cost of project power would
be $182,473 or $72.06/MWh. Overall, the project would produce power at
a cost which is $51,346 or $21.20/MWh, more than the cost of
alternative power.

4.3 COST OF ENVIRONMENTAL MEASURES

    Table 8 gives the cost of each of the environmental enhancement
measure considered in our analysis. We convert all costs to equal
annual (levelized) values over a 30-year period of analysis to give a
uniform basis for comparing the benefits of a measure to its cost.

  Table 8--Cost of Environmental Mitigation and Enhancement Measures Considered in Assessing the Environmental
                            Effects of Continued Operation of the Elk Rapids Project
                                                 [Source: Staff]
----------------------------------------------------------------------------------------------------------------
                                                    Capital cost     Annual cost   Levelized cost
Enhancement/mitigation measure       Entities         (2015 $)        (2015 $)      (2015 $) \1\       Notes
----------------------------------------------------------------------------------------------------------------
Project Operations:
    Operate the project in a    Antrim County,                 $0              $0              $0  a, b
     modified run-of river       Staff.
     mode, except as necessary
     to seasonally drawdown or
     refill the project
     reservoir.
    Maintain the water surface  Antrim County,                  0               0               0  a, b
     elevation of the project    Staff.
     reservoir at 590.8 feet
     dam gage datum April 15
     to November 1 and 590.2
     feet dam gage datum from
     November 1 to April 15,
     except as necessary to
     seasonally drawdown or
     refill the reservoir.
    Develop an operation        Staff............           2,000             325             508  a
     compliance monitoring
     plan in consultation with
     the Michigan DNR and
     Michigan DEQ.
Aquatic Resources:
    Monitor water temperature   Michigan DEQ.....           1,500             250             158  a, f
     and DO downstream of the
     project from July 1
     through August 31 on an
     annual basis, unless upon
     Michigan DEQ approval,
     results indicate the
     monitoring requirements
     may be relaxed.
    Ensure project operation    Michigan DEQ.....               0               0               0  a, e
     does not cause water
     temperatures or DO
     concentrations downstream
     of the project to exceed
     state water quality
     standards.
    Consult with Michigan DEQ   Michigan DEQ.....               0               0               0  a
     in the event of adverse
     conditions which prevent
     Antrim County from
     complying with
     operational requirements.
    Consult with the            Staff............               0               0               0  a
     Commission, Michigan DEQ,
     and Michigan DNR in the
     event of adverse
     conditions which prevent
     Antrim County from
     complying with
     operational requirements.
    Post signage that           Staff............           1,000             100             191  a
     describes proper boat
     maintenance techniques to
     reduce the spread of
     curlyleaf pondweed,
     Eurasian watermilifoil,
     and zebra mussels.
Recreation Resources:
    Operate and maintain the    Antrim County,                  0             252             252  d
     existing angler walkway,    Staff.
     which is attached to the
     tailrace side of the
     powerhouse, and parking
     lot.
Cultural Resources:
    Cease project activities    Staff............               0               0               0  a, c
     should archaeological
     resources be identified
     during project operation
     or other project-related
     activities and consult
     with the Michigan SHPO to
     determine appropriate
     treatment.
----------------------------------------------------------------------------------------------------------------
\1\ Costs were rounded to the nearest dollar.
\a\ Cost estimated by staff.
\b\ This measure represents a continuation of existing conditions, so there would be no additional cost to
  implement this measure.
\c\ Staff estimates that the cost to implement this measure would be negligible.
\d\ Cost provided by Antrim County in its Additional Information Response filed on October 16, 2013.
\e\ Staff was unable to assign a cost for this measure, because the project currently has no ability to control
  water temperature.
\f\ The monitoring cost is $250 for the first year only, which equates to an annualized cost of 21.

5.0 CONCLUSIONS AND RECOMMENDATIONS

5.1 COMPREHENSIVE DEVELOPMENT AND RECOMMENDED ALTERNATIVE

    Sections 4(e) and 10(a) of the FPA require the Commission to give
equal consideration to the power development purposes and to the
purposes of energy conservation; the protection, mitigation of damage
to, and enhancement of fish and wildlife; the protection of
recreational opportunities; and the preservation of other aspects of
environmental quality. Any licenses issued shall be such as in the
Commission's judgment will be best adapted to a comprehensive plan for
improving or developing waterway or waterways for all beneficial public
uses. This section contains the basis for, and a summary of, our
recommendations for the relicensing of the Elk Rapids Project. We weigh
the costs and benefits of our recommended alternative against other
proposed measures.
A. Recommended Alternative
    Based on our independent review of agency comments filed on these
projects and our review the environmental and economic effects of the
proposed project and economic effects of the project and its
alternatives, we selected the staff alternative as the preferred
alternative. We recommend the staff alternative because: (1) Issuance
of a new

hydropower license by the Commission would allow Antrim County to
continue operating the project as a dependable source of electrical
energy; (2) the 0.700 MW of electric capacity comes from a renewable
resource that does not contribute to atmospheric pollution; (3) the
public benefits of the staff alternative would exceed those of the no-
action alternative; and (4) the proposed measures would protect and
enhance aquatic and recreation resources.
    In the following sections, we make recommendations as to which
environmental measures recommended by agencies or other entities should
be included in any license issued for the project. We also recommend
additional staff-recommended environmental measures to be included in
any license issued for the project and discuss which measures we do not
recommend including in the license.
5.1.1 Measures Proposed by Antrim County
    Based on our environmental analysis of Antrim County's proposal
discussed in section 3 and the costs discussed in section 4, we
conclude that the following environmental measure proposed by Antrim
County would protect and enhance environmental resources and would be
worth the cost. Therefore, we recommend including these measures in any
license issued for the project:
     Operate and maintain the existing angler walkway, which is
attached to the tailrace side of the powerhouse, and associated parking
lot.
5.1.2 Additional Measures Recommended by Staff
    In addition to Antrim County's proposed measure noted above, we
recommend including the following measures in any license issued for
Antrim County:
     An operation compliance monitoring plan that includes a
description of project operation and the equipment and procedures
necessary to maintain and monitor compliance with the operational mode
required in any license issued;
     posting signage that describes proper boat maintenance
techniques to reduce the spread of invasive plant and mussel species;
and
     if archaeological resources are discovered during project
operation or other project-related activities, cease all activities
related to the disturbance and discovery area, and consult with the
Michigan SHPO to determine appropriate treatment.
    Below, we discuss the basis for our additional staff-recommended
measures.
Operation Compliance Monitoring Plan
    Developing an operation compliance monitoring plan would provide a
means to verify compliance with the operational requirements of any
license issued for the project. An operation compliance monitoring plan
would include a description of project operation and any mechanisms or
structures that would be used to by Antrim County to monitor project
operation. Therefore, we recommend that Antrim County develop, in
consultation with Michigan DEQ and Michigan DNR, an operation
compliance monitoring plan. Antrim County should file the plan for
Commission approval, documenting consultation with these agencies,
including any comments received on the plan and responses to those
comments. The plan should also provide a detailed description of the
protocols Antrim County would implement during scheduled and
unscheduled project shutdowns, reservoir drawdown and refills, and a
provision to file an annual report of the operational data with the
Commission. Based on our review and analysis contained in section
3.3.1, Aquatic Resources, we find that the benefits of ensuring an
adequate means by which the Commission could track compliance with the
operations terms of any license issued for the project would be worth
the estimated levelized annual cost of $508.
Invasive Species Prevention
    Aquatic invasive species compete with native species for food and
habitat, and can directly or indirectly kill or displace native
species, degrade habitat, and alter food webs. As discussed in section
3.3.1, Aquatic Resources, zebra mussels are found within the project
boundary and throughout the chain-of-lakes watershed. Additionally,
Eurasian milfoil and curly-leaf pondweed are within and adjacent to the
project boundary and present in the chain-of-lakes.
    Curlyleaf pondweed, Eurasian watermilifoil, and zebra mussels are
all transferred to other waterbodies primarily by boats. Zebra mussels
are so pervasive throughout the chain-of-lakes that Michigan DEQ has no
plan to control or eradicate them in the chain-of-lakes watershed.
However, public education may help to minimize, and could reduce the
likelihood of, transferring zebra mussels to other water bodies. Also,
public education on how to minimize the transfer of curlyleaf pondweed
and Eurasian watermilifoil could reduce the likelihood of further
invasions of project waters. Therefore, we recommend that Antrim County
develop signage, in consultation with the Michigan DNR and Michigan
DEQ, which contains information on proper cleaning and drying of boats
between launches to reduce the spread of curlyleaf pondweed, Eurasian
watermilifoil, and zebra mussels. The project's recreation site is near
a marina; therefore, we recommend posting the signage at the project
recreation site to help inform the public of proper management
techniques to reduce the spread of these invasive species.
    We estimate that the levelized annual cost of the measure would be
$191, and conclude that the benefits of the measure would outweigh the
costs.
Cultural Resources
    As discussed in section 3.3.5, Cultural Resources, no historic
properties would be affected by the Elk Rapids Project; however, there
is a possibility that unknown archaeological resources may be
discovered during project operation or project-related activities. To
ensure proper treatment if any unknown archaeological resource may be
discovered, we recommend that Antrim County notify and consult with the
Michigan SHPO: (1) To determine if a discovered archaeological resource
is eligible for the National Register; (2) if the resource is eligible,
determine if the proposed project would adversely affect the historic
property; and (3) if the historic property would be adversely affected,
obtain guidance from the Michigan SHPO on how to avoid, lessen, or
mitigate for any adverse effects.
5.1.3 Measures Not Recommended by Staff
    Some of the measures recommended by Michigan DEQ would not
contribute to the best comprehensive use of the Elk River water
resources, do not exhibit sufficient nexus to project environmental
effects, or would not result in benefits to non-power resources that
would be worth their costs. The following discusses the basis for
staff's conclusion not to recommend such measures.
Water Quality Monitoring
    Michigan DEQ recommends that Antrim County operate the project in
such a manner as to adhere to state water quality standards (for
temperature and DO) in the Elk River downstream of the powerhouse.
However, Michigan DEQ states that deviations from these water
temperature standards would be

acceptable when natural temperatures of Elk Lake, as measured in the
Elk River upstream of the project, exceed these specified monthly
average temperature values. Michigan DEQ also recommends that project
operation not cause DO concentrations to be less than the state
standard of 7.0 mg/L in the Elk River downstream of the powerhouse at
any time. To verify project-related effects on water quality, Michigan
DEQ recommends that Antrim County monitor temperature and DO
concentrations in the Elk River downstream of the project on an hourly
basis from July 1 through August 31 beginning the first year after
license issuance, for a minimum of one year.
    Continued operation of the project in the same mode of operation
that it has been would likely result in the same water quality in the
Elk River downstream of the dam. As discussed in section 3.3.1, Aquatic
Resources, recent and previous water quality studies demonstrate that
surface water temperatures of Elk Lake occasionally exceed state
standards usually in late summer, while water surface DO concentrations
typically exceed state minimum standards throughout the year. Because
any deviations in water temperatures would be caused by natural
phenomena and not project operation, monitoring water temperature
downstream of the project would not provide any additional benefits.
    Additionally, given that downstream of the project the less than
0.5-mile-long Elk River flows directly into Grand Traverse Bay, any
temporary decreases in DO levels that may occur in the tailrace would
be quickly mitigated by the high DO levels present in the bay.
Therefore, continued operation of the project in the same mode of
operation it has used in the past, would likely not effect water
quality in the Elk River downstream of the powerhouse and that the
state DO standard of 7 mg/L would continue to be met. For these
reasons, we do not recommend adopting Michigan DEQ's water quality
monitoring recommendations because the information obtained from
conducting this water quality monitoring is not worth the estimated
levelized annual costs of $158.
5.1.4 Conclusion
    Based on our review of the resource agency and public comments
filed on the project and our independent analysis pursuant to sections
4(e), 10(a)(1), and 10(a)(2) of the FPA, we conclude that licensing the
Elk Rapids Project, as proposed by Antrim County, with staff-
recommended additional measures, would be best adapted to a plan for
improving or developing the Elk River waterway.

6.0 CONSISTENCY WITH COMPREHENSIVE PLANS

    Section 10(a)(2)(A) of the FPA, 16 U.S.C. 803(a)(2)(A), requires
the Commission to consider the extent to which a project is consistent
with the federal or state comprehensive plans for improving,
developing, or conserving a waterway or waterways affected by the
project. We reviewed eight comprehensive plans that are applicable to
the project.\26\ No inconsistencies were found.
---------------------------------------------------------------------------

    \26\ (1) Michigan Department of Environmental Quality. 1996.
Non-indigenous aquatic nuisance species, State management plan: A
strategy to confront their spread in Michigan. Lansing, Michigan;
(2) Michigan Department of Natural Resources. 1994. Fisheries
Division strategic plan. Lansing, Michigan. June 1994; (3) Michigan
Department of Natural Resources. Statewide Comprehensive Outdoor
Recreation Plan (SCORP): 2008-2012. Lansing, Michigan; (4) National
Park Service. The Nationwide Rivers Inventory. Department of the
Interior, Washington, DC 1993; (5) U.S. Fish and Wildlife Service.
Canadian Wildlife Service. 1986. North American waterfowl management
plan. Department of the Interior. Environment Canada. May 1986; (6)
U.S. Fish and Wildlife Service. 1988; (7) The Lower Great Lakes/St.
Lawrence Basin: A component of the North American waterfowl
management plan. December 29, 1988; (8) U.S. Fish and Wildlife
Service. 1993. Upper Mississippi River & Great Lakes region joint
venture implementation plan: A component of the North American
waterfowl management plan. March 1993.
---------------------------------------------------------------------------

7.0 FINDING OF NO SIGNIFICANT IMPACT

    On the basis of our independent analysis, the issuance of a
subsequent license for the Elk Rapids Hydroelectric Project with our
recommended environmental measures would not constitute a major federal
action significantly affecting the quality of the human environment.

8.0 LITERATURE CITED

Aadland, L.P. 2010. Chapter 2: Nature-like Fishways p. 43-95. In
Reconnecting Rivers: Natural Channel Design in Dam Removals and Fish
Passage. Minnesota Department of Natural Resources--Ecological
Resources Division. Fergus Falls, Minnesota. 196 pp.
Antrim County. 2012. Elk Rapids Hydroelectric Project, FERC No.
3030. License Application. Prepared by Antrim County, Bellaire, MI.
Filed December 21, 2012.
Beall, M. 2005. Aquatic Invasive Species: A handbook for education
efforts. Wisconsin Department of Natural Resources. Publication WT-
825 2005.
Bolding, B., S. Bonar, and M. Divens. 2004. Use of artificial
structure to enhance angler benefits in lakes, ponds, and
reservoirs: A literature review. Reviews in Fisheries Science.
12:75-96.
Diana, J.S., Hanchin, P., and Popoff, N. 2014. Movement patterns and
spawning sites of muskellunge Esox masquinongy in the Antrim chain
of lakes, Michigan. Environmental Biology of Fishes, 1-12.
__. 2014. My WATERS Mapper. Waterbody ID: MI040601050404-01 [Online]
URL: http://watersgeo.epa.gov/. Accessed November 17, 2014.
Electric Power Research Institute (EPRI). 1992. Fish entrainment and
turbine mortality review and guidelines. Prepared by Stone and
Webster Environmental Services, Boston, Massachusetts. EPRI Report
No. TR-101231, Project 2694-01. September 1992.
__. 1997. Turbine Entrainment and Survival Database--Field Tests.
EPRI Report No. TR-108630. Prepared by Alden Research Laboratory,
Inc. Holden, MA.
Federal Energy Regulatory Commission (FERC). 1995. Preliminary
assessment of fish entrainment at hydropower projects: A report on
studies and protective measures. Paper No. DRP-10. Office of
Hydropower Licensing, Washington, DC.
Fuller, D.R. 2001. Fish of the Elk River Chain of Lakes: A Watershed
Perspective. Tip of the Mitt Watershed Council. Petoskey, Michigan.
Gillespie, R., W.B. Harrison III, and M.G. Grammer. 2008. Geology of
Michigan and the Great Lakes. Michigan Geological Repository for
Research and Education. Western Michigan University, Kalamazoo, MI.
37 pp.
Higman, P.J. and M.R. Penskar. 2000. Special plant abstract for
Cirsium pitcheri. Michigan Natural Features Inventory, Lansing, MI.
3 pp.
Karatayev, A.Y., L. E. Burlakova, and D.K. Padilla. 2014. Zebra
versus quagga mussels: A review of their spread, population
dynamics, and ecosystem impacts. Hydrobiologia, 1-16.
Leung, B., J.M. Bossenbroek and D.M. Lodge. 2006. Boats, pathways,
and aquatic biological invasions: Estimating dispersal potential
with gravity models. Biological Invasions 8:241-254.
Madsen, J.D. 2009. Chapter 13.2: Eurasian Watermilfoil, pp. 95-98.
In: Biology and control of aquatic plants: A best management
practices handbook (Gettys LA, WT Haller and M Bellaud, eds.).
Aquatic Ecosystem Restoration Foundation, Marietta GA. 210 pp.
Mayfield, H.F. 1992. Kirtland's warbler (Dendrocia Kirtlandii). In
A. Poole, P. Stettenheim, and F. Gill (editors). The Birds of North
America, No. 19. The Academy of Natural Sciences, Philadelphia,
Pennsylvania, and The American Ornthologists' Union, Washington, DC.
16 pp.
Michigan Department of Environmental Quality (Michigan DEQ). 2002.
Michigan's Aquatic Nuisance Species State Management Plan Update.
Lansing, Michigan. October 2002. Available: http://www.deq.state.mi.us/documents/deq-ogl-ANSPlan2002.pdf. Accessed
December 22, 2013.
Michigan Department of Natural Resources

(Michigan DNR). 1990. Fish Population Survey--Elk Lake. Lansing,
Michigan.
__. 1996. Fish Population Survey--Skegemog Lake. Lansing, Michigan.
__. 2011. Fish Population Survey Summary--Elk and Skegemog Lakes--
2008-2009. Available: http://www.michigan.gov/documents/dnr/Elk-Skegemog-lakes_242175_7.pdf. Accessed March 18, 2014.
__. 2013. Elk River Bypass/Kids Pond. [Online] URL: http://
www.michigan.gov/dnr/0,4570,7-153-10364_53405-302280_,00.html.
Accessed December 12, 2013.
__. 2014. Skegemog Lake. [Online] URL: http://www.michigan.gov/dnr/
0,4570,7-153-10364_53405-302291_,00.html. Accessed November 10,
2014.
__. 2015. Houghton's Goldenrod (Solidago houghtonii). [Online] URL:
http://www.michigan.gov/dnr/0,4570,715310370_12146_1221361388,00.html. Accessed April 20, 2015.
Michigan Surface Water Information Management System (MiSWIMS).
2014. Map Search: Designated uses. [Online] URL: http://www.mcgi.state.mi.us/miswims/mapBasic.aspx. Accessed December 3,
2014.
Michigan Natural Features Inventory. 1999. Land type Associations of
the Leelanau and Grand Traverse Peninsula: Subsection VII.5.
Lansing. Michigan.
__. 2015. Watershed Element Data; listing of all known occurrences
of threatened, endangered, and special concern species and high
quality natural communities occurring within a watershed. HUC IDs:
04060105--0404, 0405, 0406, and 0407. Michigan State University
Extension Services. [Online] URL: http://mnfi.anr.msu.edu/data/watshd.cfm. Accessed April 13, 2015.
Nalepa, T.F., and D.W. Schloesser. 1993. Zebra Mussels Biology,
Impacts, and Control. Lewis Publishers, Boca Raton: 810.
North American Electric Reliability Corporation (NERC). 2013. 2013
Long[hyphen]Term Reliability Assessment. Atlanta, GA. December 2013.
Penskar, M.R., P.J. Higman, and S.R. Crispin. 2000. Special plant
abstract for Solidago houghtonii (Houghton's goldenrod). Michigan
Natural Features Inventory, Lansing, MI. 3 pp.
Rediske, R.R,. J. O'Keefe, K. Rieger, and J.D. Rediske. 2010.
Assessment of E. coli and Microcystins in Cladophora Mats in the
Nearshore Waters of Grand Traverse Bay, Little Traverse Bay, and
Saginaw Bay. Scientific Technical Report 481062-07. Prepared For
Michigan DEQ. Paper 13.
Roni, P., K. Hanson, T.J. Beechie, G.R. Pess, M.M. Pollock, and D.M.
Bartley. 2005. Habitat rehabilitation for inland fisheries. Global
review of effectiveness and guidance for rehabilitation of
freshwater ecosystems. FAO (Food and Agriculture Organization of the
United Nations) Fisheries Technical Paper 484. Rome, FAO. 116 pp.
State of Michigan. 1994. Part 4 Rules of Part 31 of the Michigan
Water Resources Protection Act 451 of 1994, as amended.
Tip of the Mitt Watershed Council (Watershed Council). 1994. A
Cladophora Survey of Elk and Skegemog Lakes. December 1994.
Petoskey, Michigan. 21 pp.
Three Lakes Association (Lakes Associations). 2014. Elk River Chain
of Lakes Fish Shelters Project Update--Watershed Protection Plan
Implementation Team Project. Annual ERCOL-WPIT Meeting with local
units of government. [Online] URL: www.3lakes.com. Accessed March
19, 2014.
Tugend, K.I., M.S. Allen, and M. Webb. 2002. Use of artificial
habitat structures in US lakes and reservoirs: A survey from the
Southern Division AFS Reservoir Committee. Fisheries, 27(5): 22-27.
U.S. Environmental Protection Agency (EPA). 2013. Waterbody Report
for Skegemog Lake 2010. Mapped area of assessment: Elk and Skegemog
Lakes. [Online] URL: http://ofmpub.epa.gov/waters10/attains_waterbody.control?p_au_id=MI040601050404-01&p_cycle=2010.
Accessed December 16, 2013.
United States Fish and Wildlife Service (FWS). 2012. Kirtland's
Warbler (Setophaga kirtlandii)--Fact Sheet. [Online] URL: http://www.fws.gov/midwest/endangered/birds/Kirtland/kiwafctsht.html.
Accessed April 20, 2015.
__. 2013. Red knot (Calidris canutus rufa)--Fact Sheet. [Online]
URL: http://www.fws.gov/northeast/redknot/facts.pdf. Accessed April
20, 2015.
__. 2014a. Rufa red knot background information and threats
assessment. Supplement to: Endangered and Threatened Wildlife and
Plants; Final Threatened Status for the Rufa Red Knot (Calidris
canutus rufa). Docket No. FWS-R5-ES-2013-0097; RIN AY17.
__. 2014b. Northern long-eared bat interim conference and planning
guidance. USFWS Regions 2, 3, 4, 5, & 6. [Online] URL: http://www.fws.gov/northeast/virginiafield/pdf/NLEBinterimGuidance6Jan2014.pdf. Accessed May 7, 2015.
__. 2015a. IPaC Species Information. Life History for Kirtland's
Warbler (Setophaga kirtlandii). [Online] URL: http://ecos.fws.gov/ipac/wizard/speciesInformation!showSpeciesInformation.action?spcode=B03I.
Accessed April 20, 2015.
__. 2015b. Environmental Conservation Online System. Species Profile
for Northern long-eared Bat (Myotis septentrionalis). [Online] URL:
http://ecos.fws.gov/speciesProfile/profile/speciesProfile.action?spcode=A0JE. Accessed April 23, 2015.
__. 2015c. Endangered and Threatened Wildlife and Plants; Threatened
Species Status for the Northern Long-Eared Bat With 4(d) Rule.
Docket No. FWS-R5-ES-2011-0024;<PHONE_NUMBER>.
Varga, L. 2012. Fish Shelter Project Handbook. Three Lakes
Association. Available: http://3lakes.com/wp-content/uploads/2012/09/TLA-FIsh-Shelter-Handbook.pdf. Accessed November 03, 2014.
Videler, J.J. and Wardle, C.S. 1991. Fish swimming stride by stride:
Speed limits and endurance. Reviews in Fish Biology and Fisheries 1:
23-40.
Village of Elk Rapids. 2013. Five Year Community Recreation Plan.
Parks & Recreation Commission. Available: http://www.elkrapids.org/wp-content/uploads/2013/04/2013_VillageOfElkRapids_CommunityRecreationPlan__FINAL.pdf. Accessed
November 19, 2014.
Weiss, W.G. 1995. Compilation of Temperature and Dissolved Oxygen
Data for Elk Lake, 1993 and 1994. Submitted to the Elk-Skegemog Lake
Association, Elk Rapids, Michigan. February 28, 1995.
Wolf, T. 2009. Chapter 7: Mechanical control of aquatic weeds, pp.
41-46. In: Biology and control of aquatic plants: A best management
practices handbook (Gettys LA, WT Haller and M Bellaud, eds.).
Aquatic Ecosystem Restoration Foundation, Marietta GA. 210 pp.

9.0 LIST OF PREPARERS

Patrick Ely--Lead Project Coordinator, Aquatic Resources,
Terrestrial Resources, and Threatened and Endangered Species
(Fisheries Biologist; B.S., Wildlife and Fisheries Biology; M.S.,
Fisheries Biology)
Lee Emery--Assistant Project Coordinator, Aquatic Resources
(Fisheries Biologist; B.S., Biology; M.S., Zoology)
Chelsea Hudock--Recreation Resources, Land Use, and Cultural
Resources (Outdoor Recreation Planner; M.S., Recreation, Park and
Tourism Sciences; B.S., Parks, Recreation and Tourism Management)
Paul Makowski--Need for Power and Developmental Analysis (Civil
Engineer; B.S., Civil Engineering; M. Eng., Hydrosystems)

[FR Doc. 2015-12463 Filed 5-21-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 188 (Wednesday, September 28, 2016)]
[Rules and Regulations]
[Pages 66530-66532]
[FR Doc No: 2016-23318]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2016-0883]
RIN 1625-AA00

Safety Zone; Main Branch of the Chicago River, Chicago, IL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
Main Branch of the Chicago River, Chicago, IL. This action is necessary
and intended to ensure safety of life on the navigable waters of the
United States immediately prior to, during, and after the filming of a
motion picture from a low flying helicopter. Entry of vessels or
persons into this zone is prohibited unless specifically authorized by
the Captain of the Port Lake Michigan.

DATES: This rule will be effective from 6 p.m. on October 1, 2016 to 11
p.m. on October 2, 2016.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2016-0883 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions about this rule,
call or email LT Lindsay Cook, Marine Safety Unit Chicago, U.S. Coast
Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable. The
final details for this event were not known to the Coast Guard until
there was insufficient time remaining before the event to publish a
NPRM. Thus, delaying the effective date of this rule to wait for a
comment period to run would be impracticable because it would inhibit
the Coast Guard's ability to protect the public and vessels from the
hazards associated with the filming from a low flying helicopter on
October 1, 2016, or an alternate date of October 2, 2016.
    We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for making this temporary rule
effective less than 30 days after publication in the Federal Register.
For the same reasons discussed in the preceding paragraph, waiting for
a 30 day notice period to run would be impracticable.

III. Legal Authority and Need for Rule

    The legal basis for the rule is the Coast Guard's authority to
establish safety zones: 33 U.S.C. 1231; 33 CFR 1.05-1, 160.5;
Department of Homeland Security Delegation No. 0170.1.
    On October 1, 2016 or an alternate date of October 2, 2016, filming
from a low flying helicopter will take place on the Main Branch of the
Chicago River between the Franklin-Orleans Street Highway Bridge and
the Michigan Avenue Highway Bridge in Chicago, IL. The Captain of the
Port Lake Michigan has determined that the filming from a low flying
helicopter will pose a significant risk to public safety and property.
Such hazards include rotor turbulence, strong gusts of air, and close
proximity of any vessel on the Chicago River.

IV. Discussion of the Rule

    With the aforementioned hazards in mind, the Captain of the Port
Lake Michigan has determined that this temporary safety zone is
necessary to ensure the safety of the public during the filming from a
low flying helicopter on the Main Branch of the Chicago River. This
safety zone will be enforced intermittently from 6 p.m. to 11 p.m. on
October 1, 2016, or an alternate date of October 2, 2016. This zone
will encompass all waters of the Main Branch of the Chicago River
between the Franklin-Orleans Street Highway Bridge and the Michigan
Avenue Highway Bridge in Chicago, IL.
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Lake Michigan,
or a designated on-scene representative. The Captain of the Port or a
designated on-scene representative may be contacted via VHF Channel 16.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This rule has not been designated
a ``significant regulatory action,'' under Executive order 12866.
Accordingly, it has not been reviewed by the Office of Management and
Budget.
    We conclude that this rule is not a significant regulatory action
because we anticipate that it will have minimal impact on the economy,
will not interfere with other agencies, will not adversely alter the
budget of any grant or loan recipients, and will not raise any novel
legal or policy issues. The safety zone created by this rule will be
relatively small and enforced intermittently on October 1, 2016, or an
alternate date of October 2, 2016 from 6 p.m. to 11 p.m. Under certain
conditions, moreover, vessels may still transit through the safety zone
when permitted by the Captain of the Port.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered the impact of this temporary rule on small entities. This
rule will affect the following entities, some of which might be small
entities: The owners or operators of vessels intending to transit on a
portion of the Main Branch of the Chicago River on October 1, 2016, or
an alternate date of October 2, 2016 from 6 p.m. to 11 p.m.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the reasons cited in the
Regulatory Planning and Review section. Additionally, before the
enforcement of the zone, we will issue local Broadcast Notice to
Mariners and Public Notice of Safety Zone so vessel owners and
operators can plan accordingly.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person

listed in the FOR FURTHER INFORMATION CONTACT section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive order
13132.
    Also, this rule does not have tribal implications under Executive
order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves the establishment of a safety zone for filming from a low
flying helicopter on the Main Branch of the Chicago River in Chicago,
IL. It is categorically excluded from further review under paragraph
34(g) of Figure 2-1 of the Commandant Instruction. An environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T09-0883 to read as follows:

Sec.  165.T09-0883  Safety Zone; Main Branch of the Chicago River,
Chicago, IL.

    (a) Location. All waters of the Main Branch of the Chicago River
between the Franklin-Orleans Street Highway Bridge and the Michigan
Avenue Highway Bridge.
    (b) Enforcement Period. This rule will be enforced intermittently
on October 1, 2016 from 6 p.m. to 11 p.m. or an alternate date of
October 2, 2016 from 6 p.m. to 11 p.m.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into, transiting, or anchoring within
this safety zone is prohibited unless authorized by the Captain of the
Port Lake Michigan or a designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Lake Michigan or a designated
on-scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port Lake
Michigan is any Coast Guard commissioned, warrant or petty officer who
has been designated by the Captain of the Port Lake Michigan to act on
his or her behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port Lake Michigan or an on-scene
representative to obtain permission to do so. The Captain of the Port
Lake Michigan or an on-scene representative may be contacted via VHF
Channel 16. Vessel operators given permission to enter or operate in
the safety zone must comply with all directions given to them by the
Captain of the Port Lake Michigan, or an on-scene representative.

    Dated: September 21, 2016.
A.B. Cocanour,
Captain, U.S. Coast Guard, Captain of the Port, Lake Michigan.
[FR Doc. 2016-23318 Filed 9-27-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 128 (Wednesday, July 6, 2022)]
[Notices]
[Pages 40247-40248]
[FR Doc No: 2022-14359]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0008]

Request for Nominations on Public Advisory Panels of the Medical
Devices Advisory Committee

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
nonvoting industry representatives to serve on certain panels of the
Medical Devices Advisory Committee (MDAC or Committee) in the Center
for Devices and Radiological Health (CDRH) notify FDA in writing. FDA
is also requesting nominations for nonvoting industry representatives
to serve on certain device panels of the MDAC in the CDRH. A nominee
may either be self-nominated or nominated by an organization to serve
as a nonvoting industry representative. Nominations will be accepted
for current and upcoming vacancies effective with this notice.

DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to the FDA by August
5, 2022 (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by August 5, 2022.

ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nomination should be sent to Margaret Ames (see
FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting
industry representatives should be submitted electronically by
accessing the FDA Advisory Committee Membership Nomination Portal:
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or
by mail to Advisory Committee Oversight and Management Staff, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002. Information about becoming a member of an
FDA advisory committee can also be obtained by visiting FDA's website
at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Margaret Ames, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5213, Silver Spring, MD 20993,<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for
nonvoting industry representatives to the panels listed in the table in
this document.

I. Medical Devices Advisory Committee

    The Committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational devices and makes
recommendations for their regulation. The panels engage in a number of
activities to fulfill the functions the Federal Food, Drug, and
Cosmetic Act (FD&C Act) envisions for device advisory panels. With the
exception of the Medical Devices Dispute Resolution Panel, each panel,
according to its specialty area, advises the Commissioner of Food and
Drugs (the Commissioner) regarding recommended classification or
reclassification of devices into one of three regulatory categories;
advises on any possible risks to health associated with the use of
devices; advises on formulation of product development protocols;
reviews premarket approval applications for medical devices; reviews
guidelines and guidance documents; recommends exemption of certain
devices from the application of portions of the FD&C Act; advises on
the necessity to ban a device; and responds to requests from the Agency
to review and make recommendations on specific issues or problems
concerning the safety and effectiveness of devices. With the exception
of the Medical Devices Dispute Resolution Panel, each panel, according
to its specialty area, may also make appropriate recommendations to the
Commissioner on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices. The Committee also provides recommendations to the
Commissioner or designee on complexity categorization of in vitro
diagnostics under the Clinical Laboratory Improvement Amendments of
1988.

------------------------------------------------------------------------
              Panels                              Function
------------------------------------------------------------------------
Clinical Chemistry and Clinical     Reviews and evaluates data
 Toxicology Devices Panel.           concerning the safety and
                                     effectiveness of marketed and
                                     investigational in vitro devices
                                     for use in clinical laboratory
                                     medicine, including clinical
                                     toxicology, clinical chemistry,
                                     endocrinology and oncology and
                                     makes appropriate recommendations
                                     to the Commissioner of Food and
                                     Drugs.
Immunology Devices Panel..........  Reviews and evaluates data
                                     concerning the safety and
                                     effectiveness of marketed and
                                     investigational in vitro devices
                                     for use in clinical laboratory
                                     medicine, including oncology,
                                     immunology, and allergy and makes
                                     appropriate recommendations to the
                                     Commissioner of Food and Drugs.
Gastroenterology-Urology Devices    Reviews and evaluates data
 Panel.                              concerning the safety and
                                     effectiveness of marketed and
                                     investigational gastroenterology,
                                     urology, and nephrology devices and
                                     makes appropriate recommendations
                                     to the Commissioner of Food and
                                     Drugs.
General Hospital and Personal Use   Reviews and evaluates data
 Devices Panel.                      concerning the safety and
                                     effectiveness of marketed and
                                     investigational general hospital,
                                     infection control and personal use
                                     devices and makes appropriate
                                     recommendations to the Commissioner
                                     of Food and Drugs.
Ophthalmic Devices Panel..........  Reviews and evaluates data
                                     concerning the safety and
                                     effectiveness of marketed and
                                     investigational devices for use in
                                     the eye and makes appropriate
                                     recommendations to the Commissioner
                                     of Food and Drugs.
------------------------------------------------------------------------

II. Qualifications

    Persons nominated for the device panels should be full-time
employees of firms that manufacture products that would come before the
panel, or consulting firms that represent manufacturers, or have
similar appropriate ties to industry.

III. Selection Procedure

    Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations, and a list of all nominees
along with their current r[eacute]sum[eacute]s. The letter will also
state that it is the responsibility of the interested organizations to
confer with one another and to select a candidate, within 60 days after
the receipt of the FDA letter, to serve as the nonvoting member to
represent industry interests for a particular device panel. The
interested organizations are not bound by the list of nominees in
selecting a candidate. However, if no individual is selected within 60
days, the Commissioner will select the nonvoting member to represent
industry interests.

IV. Application Procedure

    Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Nomination must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address and telephone number, email address if
available, and a signed copy of the Acknowledgement and Consent form
available at the FDA Advisory Committee Membership Nomination Portal
(see ADDRESSES) within 30 days of publication of this document (see
DATES). Nominations must also specify the advisory panel for which the
nominee is recommended. Nominations must also acknowledge that the
nominee is aware of the nomination unless self-nominated. FDA will
forward all nominations to the organizations expressing interest in
participating in the selection process for the particular device panels
listed in the table. (Persons who nominate themselves as nonvoting
industry representatives will not participate in the selection
process).
    FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: June 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14359 Filed 7-5-22; 8:45 am]
BILLING CODE 4164-01-P