[Federal Register: June 14, 2010 (Volume 75, Number 113)]
[Rules and Regulations]
[Page 33506]
[DOCID:fr14jn10-7]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-1096]

Safety Zones: Fireworks Displays in the Captain of the Port
Portland Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce several safety zones for
fireworks displays being held in the Captain of the Port Portland Zone
this summer. The dates and times that the zones will be enforced are
listed below. This action is necessary to help ensure the safety of the
maritime public during the fireworks displays. During the enforcement
period for each respective safety zone, no persons or vessels will be
allowed to enter or remain in the zone unless authorized by the Captain
of the Port or his designated representative.

DATES: The regulations in 33 CFR Section 165.1315 will be enforced from
May 1, 2010 through September 30, 2010 as specifically noted in the
SUPPLEMENTARY INFORMATION section below.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or e-mail MST1 Jaime Sayers, Waterways Management Division, Coast
Guard Sector Portland; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the following
safety zones codified in 33 CFR 165.1315 during the following dates and
times:
    (1) Portland Rose Festival Fireworks Display, Portland OR: May 28,
2010 from 8:30 p.m. until 10:30 p.m.
    (2) Cedco Inc. Fireworks Display, North Bend, OR: July 3, 2010 from
9:45 p.m. through 10:50 p.m. If the event is delayed by inclement
weather, the safety zone will also be enforced on July 4, 2010 from
9:45 p.m. through 10:50 p.m.
    (3) Astoria 4th of July Fireworks, Astoria, OR: July 4, 2010 from
8:30 p.m. through 11:30 p.m.
    (4) Oregon Food Bank Blues Festival Fireworks, Portland, OR: July
4, 2010 from 8:30 p.m. through 11:30 p.m.
    (5) Florence Chamber 4th of July Fireworks Display, Florence, OR:
July 4, 2010 from 9 p.m. through 11 p.m.
    (6) Oaks Park July 4th Celebration, Portland, OR: July 4, 2010 from
9 p.m. 11 p.m.
    (7) Rainier Days Fireworks Celebration, Rainier, OR: July 10, 2010
from 9 p.m. through 11 p.m.
    (8) Milwaukie Centennial Fireworks Display, Milwaukie, OR: July 24,
2010 from 9 p.m. through 11 p.m.
    (9) Splash Aberdeen Waterfront Festival, Aberdeen, WA: July 4, 2010
from 9 p.m. through 11 p.m.
    (10) Arlington Chamber of Commerce Fireworks Display, Arlington,
OR: July 4, 2010 from approximately 8:30 p.m. to approximately 11:30
p.m.
    (11) East County 4th of July Fireworks, Gresham, OR: July 4, 2010
from approximately 8:30 p.m. to approximately 11:30 p.m.
    (12) Port of Cascade Locks July 5th Fireworks Display, Cascade
Locks, OR: July 4, 2010 from approximately 8:30 p.m. to approximately
11:30 p.m.
    (13) Astoria Regatta Association Fireworks Display, Astoria, OR:
August 14, 2010 9:30 p.m. through 11:30 p.m.
    (14) City of Washougal July 4th Fireworks Display, Washougal, WA:
July 4, 2010 at approximately 8:30 p.m. to approximately 11:30 p.m.
    (15) Waverly Country Club 4th of July Fireworks Display, Milwaukie,
OR: July 4, 2010 at approximately 8:30 p.m. to 11:30 p.m.
    Under the provisions of 33 CFR 165.23, no person may enter or
remain in these safety zones unless authorized by the Captain of the
Port or his designated representative. Also in accordance with 33 CFR
Section 165.23, no person may bring into, cause to be brought into, or
allow to remain in these safety zones any vehicle, vessel, or object
unless authorized by the Captain of the Port or his designated
representative.
    This notice is issued under authority of 33 CFR 165.1315 and 5
U.S.C. 552(a).

    Dated: May 5, 2010.
F.G. Myer,
Captain, U.S. Coast Guard, Captain of the Port, Portland.
[FR Doc. 2010-14149 Filed 6-11-10; 8:45 am]
BILLING CODE 9110-04-P


870.2600    Dermal Sensitization......................................................
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
870.3100    Oral Subchronic (rodent) ...............................................
870.3150    Oral Subchronic (nonrodent) .........................................
870.3200    21-Day Dermal ..............................................................
870.3250    90-Day Dermal ..............................................................
870.3465    90-Day Inhalation..........................................................
yes
yes
yes
no
yes
yes
yes
no
-
no
870.3700a  Developmental Toxicity (rodent)...................................
870.3700b  Developmental Toxicity (nonrodent).............................
870.3800    Reproduction .................................................................
yes
yes
yes
yes
yes
yes
870.4100a  Chronic Toxicity (rodent) ..............................................
870.4100b  Chronic Toxicity (nonrodent) ........................................
870.4200a  Oncogenicity (rat)..........................................................
870.4200b  Oncogenicity (mouse)....................................................
870.4300    Chronic/Oncogenicity....................................................
yes
a
yes
yes
a
yes
yes
yes
yes
yes
yes
yes
870.5100    Mutagenicity—Gene Mutation - bacterial .....................
870.5300    Mutagenicity—Gene Mutation - mammalian ................
870.5375    Mutagenicity—Structural Chromosomal Aberrations ...
870.5900    Mutagenicity—Other Genotoxic Effects .......................
yes
yes
yes
yes
yes
yes
yes
yes
870.6100a  Acute Delayed Neurotox. (hen) .....................................
870.6100b  90-Day Neurotoxicity (hen)...........................................
870.6200a  Acute Neurotox. Screening Battery (rat)........................
870.6200b  90-Day Neuro. Screening Battery (rat)..........................
870.6300    Develop. Neuro..............................................................
no
no
yes
yes
no
-
-
no
yes
-
870.7485    General Metabolism.......................................................
870.7600    Dermal Penetration ........................................................
870.7800    Immunotoxicity..............................................................
yes
no
yes
yes
yes
no
a Guideline 870.4300 satisfies guideline 870.4100a and 870.4200a.

Page 24 of 38
A.2
Toxicity Profiles
Table 1  Acute Toxicity of Cyprodinil.
Guideline No.
Study Type
MRIDs #
Results
Toxicity Category
870.1100 Acute Oral
43709014 LD
50
= 2796 mg/kg
III
870.1200 Acute Dermal
43709016 LD
50
> 2000 mg/kg
III
870.1300 Acute Inhalation
43709018 LC
50
= 1.2 mg/L
III
870.2400
Primary Eye Irritation
43709021
mild/mod irritant
III
870.2500
Primary Skin Irritation
43709022
very slight irritant
IV
870.2600 Dermal Sensitization  43709024 positive NA
44392102
Table 2..  Toxicity Profile of Cyprodinil Technical.
Guideline No./
Study Type
MRID No. (year)/
Classification /Doses
Results
870.3100
90-Day oral toxicity
(mouse)
43709027 (1991)
Acceptable/guideline
0, 500, 2000, 6000 ppm
M: 0, 73.3, 257, 849
mg/kg/day
F: 0, 103, 349, 1121
mg/kg/day
NOAEL = 73.3/103 mg/kg/day, M/F
LOAEL = 257/349 mg/kg/day, M/F, based on
histopathological changes in the liver
870.3100
90-Day oral toxicity
(rat)
43709026 (1991)
Acceptable/guideline
0, 50, 300, 2000, 12,000
ppm
M: 0, 3.14, 19, 134, 810
mg/kg/day
F: 0, 3.24, 19.3, 137, 803
mg/kg/day
NOAEL =3.14 mg/kg/day
LOAEL = 19 mg/kg/day based on increased tubular kidney
lesions in males
Non-guideline
28-Day Feeding/
Range Finding
(rat)
43866301 (1989)
Acceptable/Non-
guideline
0, 100, 600, 3000, 15000
ppm
M: 10.3, 64.8, 316, 1460
mg/kg/day
F: 0, 10.1, 62.2, 299,
1390 mg/kg/day
NOAEL = 64.8/62.2 mg/kg/day, M/F
LOAEL = 316/299 mg/kg/day, M/F, based on lower body-
weight gains, microcytosis, increase cholesterol and
phospholipid levels, and hepatocyte hypertrophy
Non-guideline
28-Day Gavage/
Range Finding
(rat)
43737601 (1991)
Acceptable/Non-
guideline
0, 10, 100 1000
mg/kg/day
NOAEL = 10 mg/kg/day
LOAEL = 100 mg/kg/day based on increased liver weights
and abnormalities in liver morphology
870.3150
90-Day oral toxicity
43709028 (1991)
Acceptable/Guideline
NOAEL =210/232 mg/kg/day, M/F
LOAEL = 560/581 mg/kg/day, M/F, based on lower body-

Page 25 of 38
Table 2..  Toxicity Profile of Cyprodinil Technical.
Guideline No./
Study Type
MRID No. (year)/
Classification /Doses
Results
(dog)
0, 200, 1500, 7000, 20000
ppm
M: 0, 6.07, 45.85, 210.33,
559.66 mg/kg/day
F: 0, 6.79, 52.75, 231.93,
580.95 mg/kg/day
weight gains and decreased food consumption in both sexes
870.3200
21/28-Day dermal-
toxicity
(rat)
43709029 (1991)
Unacceptable/
Guideline
0, 5, 25, 125, 1000
mg/kg/day
NOAEL = 25/125 mg/kg/day, F/M
LOAEL = 125/1000 mg/kg/day, F/M, based on clinical
signs (hunched posture and/or piloerection).
870.3700a
Prenatal
developmental
(rat)
43709033 (1991)
Acceptable/Guideline
0, 20, 200, 1000
mg/kg/day
Maternal NOAEL = 200 mg/kg/day
LOAEL = 1000 mg/kg/day based on lower body-
weight/body-weight gain and reduced food consumption
Developmental NOAEL = 200 mg/kg/day
LOAEL = 1000 mg/kg/day based on lower mean fetal
weights and increased incidence of delayed ossification
870.3700b
Prenatal
developmental
(rabbit)
43709032 (1991)
Acceptable/Guideline
0, 5, 30, 150, 400
mg/kg/day
Maternal NOAEL = 150 mg/kg/day
LOAEL = 400 mg/kg/day based on decreased body-weight
gain
Developmental NOAEL = 150 mg/kg/day
LOAEL = 400 mg/kg/day based on slight increase of litters
showing extra (13 ) ribs
th
870.3800
Reproduction and
fertility effects
(rat)
43709034 (1993)
Acceptable/Guideline
0, 10, 100, 1000, 4000
ppm
M: 0, 0.7, 6.7, 68, 273
mg/kg/day
F: 0, 0.8, 8.2, 81, 326
mg/kg/day
Maternal/Systemic NOAEL = 81 mg/kg/day
LOAEL = 326 mg/kg/day based on decreased body weight
gain in the F0 females during the pre-mating period.
Reproductive/Developmental NOAEL = 81 mg/kg/day
LOAEL = 326 mg/kg/day based on decreased pup weights
(F1 and F2)
870.4300
Chronic toxicity/
Carcinogenicity
(feeding)
(rat)
43737602 (1994)
Acceptable/Guideline
0, 5, 75, 1000, 2000 ppm
M: 0, 0.177, 2.7, 35.6,
73.6 mg/kg/day
F: 0, 0.204, 3.22, 41.2,
87.1 mg/kg/day
NOAEL = 2.7 mg/kg/day
LOAEL = 35.6 mg/kg/day based on degenerative liver
lesions (spongiosis hepatis) in males
No evidence of carcinogenicity
870.4100b
Chronic toxicity
(dog)
43709030 (1991)
0, 25, 250, 2500, 15000
M: 0, 0.72, 6.87, 65.35,
449.25 mg/kg/day
F: 0, 0.76, 6.80, 67.99,
NOAEL = 65.63/67.99 mg/kg/day, M/F
LOAEL = 449.25/446.3, M/F, mg/kg/day based on lower
body-weight gains and decreased food consumption and
food efficiency

Page 26 of 38
Table 2..  Toxicity Profile of Cyprodinil Technical.
Guideline No./
Study Type
MRID No. (year)/
Classification /Doses
Results
446.37 mg/kg/day
870.3200
Carcinogenicity -
(mouse)
43709031, 44417902
Acceptable/Guideline
0, 10, 150, 2000, 5000
ppm
M: 0, 1.15, 16.1, 212.4,
630 mg/kg/day
F: 0, 1.08, 14.7, 196.3,
558.1 mg/kg/day
NOAEL = 16.1 mg/kg/day
LOAEL = 212.4 mg/kg/day based on a dose-related increase
in the incidence of focal and multifocal hyperplasia of the
exocrine pancreas in males
No evidence of carcinogenicity
870.7800
Immunotoxicity
(mouse)
48293501
Upgradeable/Guideline
0, 500, 2000, 5000 ppm
0, 103.8, 468.3, 1245.3
mg/kg/day
NOAEL > 1245.3 mg/kg/day
LOAEL > 1245.3 mg/kg/day
There were no cyprodinil-related effects on absolute,
adjusted, or relative spleen or thymus weights; no effects on
specific activity or total activity of splenic IgM antibody-
forming cells to the T cell-dependent antigen sRBC.
870.6200b
Subchronic
Neurotoxicity
45906101
Acceptable/Guideline
0,80, 800, 8000 ppm
M: 0, 5.8, 54.5, 601
F: 0, 6.3, 58.7, 631
mg/kg/day
Neurotoxicity NOAEL > 601 mg/kg/day M; 631 mg/kg/day
F
Neurotoxicity LOAEL > 601 mg/kg/day M; 631 mg/kg/day
F


[Federal Register Volume 80, Number 91 (Tuesday, May 12, 2015)]
[Notices]
[Page 27161]
[FR Doc No: 2015-11411]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 5-098]

Confederated Salish and Kootenai Tribes, Energy Keepers,
Incorporated; Notice of Application for Partial Transfer of License and
Co-Licensee Status and Soliciting Comments, Motions To Intervene, and
Protests

    On April 14, 2015, the Confederated Salish and Kootenai Tribes
(transferor or co-licensee or CSKT) and Energy Keepers, Incorporated
(transferee or EKI) filed an application for a partial transfer of
license and co-licensee status of the Kerr Hydroelectric Project, FERC
No. 5, located on the Flathead River and Flathead Creek in Flathead
Lake County, Montana.
    The transferor and transferee seek Commission approval to partially
transfer the license for the Kerr Hydroelectric Project from
NorthWestern Corporation and Confederated Salish and Kootenai Tribes as
co-licensees to Confederated Salish and Kootenai Tribes and
Northwestern and add the transferee as a co-licensee. The transfer
application was filed by CSKT and EKI. Northwestern specially joined
the application and does not dispute the representations made by CSKT
and/or EKI, concerning: (1) The legal or financial status of either
CSKT or EKI; or (2) the organizational structure, staffing or proposed
operations by either CSKT or EKI.
    Applicant Contacts: For Transferors: Rhonda Swaney, Confederated
Salish and Kootenai Tribes, P.O. Box 278, Pablo, MT 59855, Phone: 406-
675-2700, Email<EMAIL_ADDRESS>John K. Tabaracci, Corporate
Counsel, NorthWestern Corporation, 208 North Montana Avenue, Suite,
205, Helena, MT 59601, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>Matthew A. Love, Van Ness Feldman,
LLP, 719 Second Avenue, Suite 1150, Seattle, WA 98104, Phone: 206-623-
9372, Email<EMAIL_ADDRESS>For Transferee: Joe Hovenkotter, Energy
Keepers, Inc., 110 Main Street, Suite 304, Polson, MT 59860, Phone:
406-883-1113, Email<EMAIL_ADDRESS>Gary D.
Bachman, Van Ness Feldman, LLP, 1050 Thomas Jefferson Street NW.,
Seventh Floor, Washington, DC 20007, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>.
    Deadline for filing comments and motions to intervene: 30 days from
the issuance date of this notice, by the Commission. The Commission
strongly encourages electronic filing. Please file motions to intervene
and comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-5-098.

    Dated: April 28, 2015.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2015-11411 Filed 5-11-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 165 (Friday, August 26, 2022)]
[Rules and Regulations]
[Pages 52437-52438]
[FR Doc No: 2022-18343]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0715; Airspace Docket No. 22-ASW-13]
RIN 2120-AA66

Revocation of Class E Airspace; Coalgate, OK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action removes the Class E airspace at Coalgate, OK. The
FAA is taking this action due to the cancellation of the instrument
procedures at the associated airport, and the airspace no longer being
required.

DATES: Effective 0901 UTC, November 3, 2022. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11F, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at 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.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; 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
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 removes the Class E airspace extending upward from 700 feet above
the surface at Mary Hurley Hospital Heliport, Coalgate, OK, due to the
cancellation of the instrument procedures at this airport, and the
airspace no longer being required.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (87 FR 35469; June 10, 2022) for Docket No. FAA-2022-0715 to
remove the Class E airspace at Coalgate, OK. Interested parties were
invited to participate in this rulemaking effort by submitting written
comments on the proposal to the FAA. Two comments were received
supporting this action.
    Class E airspace designations are published in paragraph 6005 of
FAA Order JO 7400.11F, dated August 10, 2021, and effective September
15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designations listed in this document will be published
subsequently in FAA Order JO 7400.11F.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11F, Airspace Designations
and Reporting Points, dated August 10, 2021, and effective September
15, 2021. FAA Order JO 7400.11F is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11F lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to 14 CFR 71 removes the Class E airspace extending
upward from 700 feet above the surface at Mary Hurley Hospital
Heliport, Coalgate, OK.
    This action is the result of the instrument procedures at this
airport

being cancelled, and the airspace no longer being required.
    FAA Order JO 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 regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. 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 only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 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 JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASW OK E5 Coalgate, OK [Remove]

    Issued in Fort Worth, Texas, on August 22, 2022.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2022-18343 Filed 8-25-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 197 (Friday, October 9, 2020)]
[Notices]
[Page 64150]
[FR Doc No: 2020-22403]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1866]

Wockhardt Ltd., et al.; Withdrawal of Approval of Nine
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of nine abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of November 9, 2020.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 040533.................  Bethanechol Chloride  Morton Grove
                               Tablets, 10           Pharmaceuticals
                               milligrams (mg).      Inc./Wockhardt USA
                                                     LLC, 6451 Main St.,
                                                     Morton Grove, IL
                                                     60053.
ANDA 040534.................  Bethanechol Chloride  Do.
                               Tablets, 25 mg.
ANDA 075015.................  Acyclovir Sodium for  Fresenius Kabi USA,
                               Injection,            LLC, Three
                               Equivalent to (EQ)    Corporate Dr., Lake
                               500 mg base/vial.     Zurich, IL 60047.
ANDA 075773.................  Pamidronate Disodium  Do.
                               for Injection, 30
                               mg/vial, and 90 mg/
                               vial.
ANDA 076206.................  Calcitriol            Rockwell Medical,
                               Injection, 0.001 mg/  Inc., 30142 S.
                               milliliter (mL).      Wixom Rd., Wixom,
                                                     MI 48393.
ANDA 076207.................  Pamidronate Disodium  Fresenius Kabi USA,
                               Injection, 30 mg/10   LLC.
                               mL (3 mg/mL) and 90
                               mg/mL (9 mg/mL).
ANDA 077788.................  Albuterol Sulfate     VistaPharm, Inc.,
                               Syrup, EQ 2 mg base/  7265 Ulmerton Rd.,
                               5 mL.                 Largo, FL 33771.
ANDA 077990.................  Zolpidem Tartrate     Carlsbad Technology,
                               Tablets, 5 mg and     Inc., U.S. Agent
                               10 mg.                for Yung Shin
                                                     Pharmaceutical
                                                     Industrial Co.,
                                                     Ltd., 4761 Tara
                                                     Ct., West
                                                     Bloomfield, MI
                                                     48323.
ANDA 202410.................  Donepezil             Hisun Pharmaceutical
                               Hydrochloride         (Hangzhou) Co.,
                               Tablets, 23 mg.       Ltd., U.S. Agent,
                                                     Hisun
                                                     Pharmaceuticals
                                                     USA, Inc., 200
                                                     Crossing Blvd., 2nd
                                                     floor, Bridgewater,
                                                     NJ 08807.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
November 9, 2020. Approval of each entire application is withdrawn,
including any strengths and dosage forms inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on November 9, 2020 may continue to be dispensed until
the inventories have been depleted or the drug products have reached
their expiration dates or otherwise become violative, whichever occurs
first.

    Dated: October 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22403 Filed 10-8-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Pages 201-202]
[FR Doc No: 2017-28125]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2017-0356]

Hours of Service of Drivers: Application for Exemption; Owner
Operator Independent Drivers Association, Inc.

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of application for exemption; request for comments.

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

SUMMARY: FMCSA announces that the Owner Operator Independent Drivers
Association, Inc. (OOIDA) has requested an exemption from the
electronic logging device (ELD) requirements for motor carriers
considered to be a small transportation trucking business. OOIDA
request this exemption to allow small trucking businesses that do not
have a carrier safety rating of ``unsatisfactory,'' and can document a
proven history of safety performance with no attributable at-fault
crashes, to complete paper records of duty status (RODS) instead of
using an ELD device. OOIDA believes that the exemption would not have
any adverse impacts on operational safety as motor carriers and drivers
would remain subject to the hours-of-service (HOS) regulations as well
as the requirements to maintain paper RODS. FMCSA requests public
comment on OOIDA's application for exemption.

DATES: Comments must be received on or before February 1, 2018.

ADDRESSES: You may submit comments identified by Federal Docket
Management System (FDMS) Number FMCSA-2017-0356 by any of the following
methods:
     Federal eRulemaking Portal: www.regulations.gov. See the
Public Participation and Request for Comments section below for further
information.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
     Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to www.regulations.gov, including any personal
information included in a comment. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The on-line FDMS is available 24 hours each
day, 365 days each year.
    Privacy Act: 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 www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: For information concerning this
notice, contact Mr. Tom Yager, Chief, FMCSA Driver and Carrier
Operations Division; Office of Carrier, Driver and Vehicle Safety
Standards; Telephone:<PHONE_NUMBER>. Email: [email protected]. If you have
questions on viewing or submitting material to the docket, contact
Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2017-0356), indicate the specific section of this
document to which the comment applies, and provide a reason for
suggestions or recommendations. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so the Agency can contact you if it has questions
regarding your submission.
    To submit your comments online, go to www.regulations.gov and put
the docket number, ``FMCSA-2017-0356'' in the ``Keyword'' box, and
click ``Search.'' When the new screen appears, click on ``Comment
Now!'' button and type your comment into the text box in the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit. If you submit your
comments by mail or hand delivery, submit them in an unbound format, no
larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit comments by mail and would like to know that they
reached the facility, please enclose a stamped, self-addressed postcard
or envelope. FMCSA will consider all comments and material received
during the comment period and may grant or not grant this application
based on your comments.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain parts of the Federal Motor Carrier Safety
Regulations (FMCSRs). FMCSA must publish a notice of each exemption
request in the Federal Register (49 CFR 381.315(a)). The Agency must
provide the public an opportunity to inspect the information relevant
to the application, including any safety analyses that have been
conducted. The Agency must also provide an opportunity for public
comment on the request.
    The Agency reviews safety analyses and public comments submitted,
and determines whether granting the exemption would likely achieve a
level of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)) with the reasons for denying or granting the application
and, if granted, the name of the person or class of persons receiving
the exemption, and the regulatory provision from which the exemption is
granted. The notice must also specify the effective period and explain
the terms and conditions of the exemption. The exemption may be renewed
(49 CFR 381.300(b)).

III. Request for Exemption

    OOIDA reports that it is the largest association representing the
views of small-business motor carriers. OOIDA has approximately 160,000
members

located in all 50 states and Canada who collectively own and operate
more than 240,000 individual heavy-duty trucks.
    OOIDA is requesting an exemption from the ELD mandate scheduled to
become effective December 18, 2017, for motor carriers that are
considered to be a small trucking business as defined by 13 CFR
121.201,\1\ who do not have a carrier safety rating of
``unsatisfactory,'' and can document a proven history of safety
performance with no attributable at-fault crashes.
---------------------------------------------------------------------------

    \1\ The Small Business Administration size standard for truck
transportation and local delivery services is currently $27.5
million. https://www.sba.gov/sites/default/files/files/Size_Standards_Table_2017.pdf.
---------------------------------------------------------------------------

    OOIDA asserts that the exemption would not have any adverse impacts
on operational safety, as motor carriers and drivers would remain
subject to the HOS regulations in 49 CFR 395.3, as well as the
requirements to maintain a paper RODS under 49 CFR 395.8. The exemption
would also allow small-business motor carriers to maintain their
current practices that have resulted in a proven safety record. The
term of the requested exemption, if granted, is for five years, subject
to renewal upon application.
    In its application, OOIDA addressed many of its concerns regarding
cybersecurity issues, cost, and the lack of validation for ELDs in the
marketplace. OOIDA believes that a five year exemption would provide
necessary time for ELD manufacturers to be fully vetted by Federal
regulators, would allow small-business carriers to determine which
device best fits their operation, and provide additional time for law
enforcement to analyze which devices fulfill regulatory requirements.
    OOIDA concluded: ``Many OOIDA members with millions of accident-
free miles driving during their career have notified us that they will
be retiring as a result of this mandate. These drivers are subject
matter experts who have driven an array of trucks in severe weather,
traffic and other conditions. If these drivers will remain in the
trucking industry as result of an exemption, then that will achieve a
level safety equal to, or greater than, the level that would be
obtained by complying with the ELD mandate. If the mandates forces
these skilled drivers out of the industry, they will be replaced with
new, inexperienced drivers that are far more likely to crash which will
not achieve an equal or higher level of safety.''
    A copy of OOIDA's application for exemption is available for review
in the docket for this notice.

    Issued on: December 22, 2017.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2017-28125 Filed 12-29-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Notices]
[Pages 63784-63785]
[FR Doc No: 2022-22816]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0399]

Current Good Manufacturing Practice for Animal Cells, Tissues,
and Cell- and Tissue-Based Products; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry #253
entitled ``Current Good Manufacturing Practice for Animal Cells,
Tissues, and Cell- and Tissue-Based Products.'' FDA's Center for
Veterinary Medicine (CVM) is issuing this guidance to provide
establishments that manufacture animal cells, tissues, and cell- and
tissue-based products (ACTPs) with recommendations for meeting
requirements for current good manufacturing practice (CGMP). All new
animal drugs, including ACTPs, are required to be manufactured in
accordance with CGMP to ensure that such drugs meet the requirements of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) as to safety, and
have the identity, strength, quality, and purity characteristics, which
they purport to or are represented to possess. This guidance also
provides FDA's recommendations for those aspects of manufacturing
specific to ACTPs in accordance with existing CGMP regulations, as
applicable, and with the FD&C Act. In this guidance, we specifically
address the methods, facilities, and controls used for manufacturing
ACTPs.

DATES: The announcement of the guidance is published in the Federal
Register on October 20, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-0399 for ``Current Good Manufacturing Practice for Animal
Cells, Tissues, and Cell- and Tissue-Based Products.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
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: Lynne Boxer, Center for Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 23, 2021 (86 FR 52911), FDA
published the notice of availability for a draft guidance entitled
``Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and
Tissue-Based Products'' giving interested persons until November 22,
2021, to comment on the draft guidance. FDA received two submissions
that contained multiple comments on the draft guidance and those
comments were considered as the guidance was finalized. Editorial
changes were made to improve clarity, for example, by making clear that
the final guidance is intended to apply to xenogeneic, allogeneic, and
autologous ACTPs and that under certain circumstances, we may not
expect an individual veterinarian or veterinary practice engaged solely
in recovering cells or tissues for further ACTP processing by third
parties to register with FDA. Other editorial changes clarify
definitions of terms used in the final guidance, such as the definition
of the term ``establishment.'' The guidance announced in this notice
finalizes the draft guidance dated September 2021.
    This level 1 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 ``Current Good Manufacturing Practice
for Animal Cells, Tissues, and Cell- and Tissue-Based Products.'' 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. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 514 have been approved under OMB control
number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22816 Filed 10-19-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Rules and Regulations]
[Pages 62308-62310]
[FR Doc No: 2022-22431]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2022-0795]
RIN 1625-AA08

Special Local Regulation; Eureka Concert Spectator Area, Eureka
Channel, Eureka, CA

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary local regulation
for the navigable waters of Eureka Channel, in the vicinity of Woodley
Island, in support of an onshore concert with spectator vessels. This
special local regulation is necessary to protect the safety of life on
these navigable waters and to ensure the safety of mariners transiting
the area from the dangers associated with the large gathering of on
water concert spectators. This special local regulation will
temporarily establish the spectator area and safe access lane to be
used for transit and emergency response access. This regulation is
necessary to provide safety of life on the navigable waters during the
event, which will be held on October 16, 2022.

DATES: This rule is effective on October 16, 2022 from 11 a.m. until 7
p.m.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG
2022-0795 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT William Harris, Waterways Management, U.S. Coast
Guard; telephone<PHONE_NUMBER>, email [email protected].

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 the 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)
because it would be impracticable to do so. This rule must be effective
on October 16, 2022, so we lack sufficient time to provide a reasonable
comment period and then consider those comments before issuing this
rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to public interest because the rule must be
effective on October 16, 2022, to ensure the safety of the participants
and vessels during the Concert Event.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70041 (previously 33 U.S.C. 1233). The Captain of the Port Sector San
Francisco (COTP) has determined that potential hazards associated with
a large gathering of on water concert spectators on October 16, 2022,
will be a safety concern for anyone within the Eureka Channel. This
rule is needed to protect personnel, vessels, and the marine
environment in the navigable waters within the special local regulation
while the event is taking place.

IV. Discussion of the Rule

    This rule establishes a special local regulation from 11 a.m. until
7 p.m. on October 16, 2022. This special local regulation involves a
designated event anchorage in the vicinity of Woodley Island Marine.
The event anchorage area will be established from a point along the
southeastern shore of Woodley Island at 40[deg]48'34.5'' N,
124[deg]9'19.7'' W; thence along the Samoa Bridge to 40[deg]48'30.3''
N, 124[deg]9'15.7''; thence along the shore to 40[deg]48'24.2'' N,
124[deg]9'30.6'' W; thence to 40[deg]48'29.4'' N, 124[deg]9'32.8'' W
and thence to the point of beginning. No vessel may moor or anchor
within 50 yards of the southernmost shoreline to allow access for
emergency vessels. This special local regulation also involves a no
loitering zone to reduce congregating in Eureka Channel during this
concert event from a point along the southwestern shore or Woodley
Island at 40[deg]48'28.0'' N, 124[deg]10'0.0'' W; thence

along the shore to 40[deg]48'29.4'' N, 124[deg]9'32.8'' W; thence to
40[deg]48'24.2'' N, 124[deg]9'30.6'' W; thence along the shore to
40[deg]48'21.9'' N, 124[deg]9'59.9'' W and thence to the point of
beginning.

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. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
location, duration, and the time-of-day of the special local
regulation. This special local regulation would impact a small
designated area of the Eureka Channel for a short duration. Moreover
the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM
marine channel 16 about the zone.

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.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    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
call or email 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.

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
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), 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 special local
regulation involves a designated event anchorage from a point along the
southeastern shore of Woodley Island at 40[deg]48'34.5'' N,
124[deg]9'19.7'' W; thence along the Samoa Bridge to 40[deg]48'30.3''
N, 124[deg]9'15.7''; thence along the shore to 40[deg]48'24.2'' N,
124[deg]9'30.6'' W; thence to 40[deg]48'29.4'' N, 124[deg]9'32.8'' W
and thence to the point of beginning. This special local regulation
also involves a no loitering zone to reduce congregating in Eureka
Channel during this concert event from a point along the southwestern
shore or Woodley Island at 40[deg]48'28.0'' N, 124[deg]10'0.0'' W;
thence along the shore to 40[deg]48'29.4'' N, 124[deg]9'32.8'' W;
thence to 40[deg]48'24.2'' N, 124[deg]9'30.6'' W; thence along the
shore to 40[deg]48'21.9'' N, 124[deg]9'59.9'' W and thence to the point
of beginning. It is categorically excluded from further review under
paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-
001-01, Rev. 1. A Memorandum For Record supporting this determination
is available in the docket. For instructions on locating the docket,
see the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email 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 100

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 46 U.S.C. 70041; 33 CFR 1.05-1.

0
2. Add Sec.  100.T11-113 to read as follows:

Sec.  100.T11-113  Special Local Regulation; Eureka Concert Spectator
Area, Eureka Channel, Eureka, CA.

    (a) Regulated area. This special local regulation involves a
designated event anchorage from a point along the southeastern shore of
Woodley Island at 40[deg]48'34.5'' N, 124[deg]9'19.7'' W; thence along
the Samoa Bridge to 40[deg]48'30.3'' N, 124[deg]9'15.7''; thence along
the shore to 40[deg]48'24.2'' N, 124[deg]9'30.6'' W; thence to
40[deg]48'29.4'' N, 124[deg]9'32.8'' W and thence to the point of
beginning. No vessel may moor or anchor within 50 yards of the
southernmost shoreline to allow access for emergency vessels. This
special local regulation also involves a no-loitering zone to reduce
congregating in Eureka Channel during this concert event from a point
along the southwestern shore or Woodley Island at 40[deg]48'28.0'' N,
124[deg]10'0.0'' W; thence along the shore to 40[deg]48'29.4'' N,
124[deg]9'32.8'' W; thence to 40[deg]48'24.2'' N, 124[deg]9'30.6'' W;
thence along the shore to 40[deg]48'21.9'' N, 124[deg]9'59.9'' W and
thence to the point of beginning.
    (b) Definitions. As used in this section--
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty officer, or other officer
operating a Coast Guard vessel and a Federal, State, and local officer
designated by or assisting the Captain of the Port San Francisco (COTP)
in the enforcement of the regulations in this section.
    (c) Regulations. All attendees are allowed to anchor within the
designated event anchorage and are restricted from remaining within the
regulated no-loitering area described in paragraph (a) of this section
unless authorized by the Captain of the Port San Francisco or their
designated representative.
    (2) To seek permission to access or for inquiries, contact the COTP
or the COTP's representative by VHF Channel 22A (157.100 mhz). Those in
the regulated area must comply with all lawful orders or directions
given to them by the COTP or the designated representative.
    (3) The COTP will provide notice of the regulated area through
advanced notice via broadcast notice to mariners and by on-scene
designated representatives.
    (d) Enforcement period. This section will be enforced from 11 a.m.
to 7 p.m. on October 16, 2022.

    Dated: October 7, 2022.
Taylor Q. Lam,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2022-22431 Filed 10-13-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16215-16216]
[FR Doc No: 2022-06036]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0417]

Shiba I. Momin: Final Debarment Order

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

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Shiba I. Momin for a period of 5 years from importing or offering for
import any drug into the United States. FDA bases this order on a
finding that Ms. Momin was convicted of one felony count under Federal
law for Conspiracy. The factual basis supporting Ms. Momin's
conviction, as described below, is conduct relating to the importation
into the United States of a drug or controlled substance. Ms. Momin was
given notice of the proposed debarment and was given an opportunity to
request a hearing to show why she should not be debarred. As of
December 26, 2021 (30 days after receipt of the notice), Ms. Momin had
not responded. Ms. Momin's failure to respond and request a hearing
constitutes a waiver of her right to a hearing concerning this matter.

DATES: This order is applicable March 22, 2022.

ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, or at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>, or at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D))
permits debarment of an individual from importing or offering for
import any drug into the United States if FDA finds, as required by
section 306(b)(3)(C) of the FD&C Act, that the individual has been
convicted of a felony for conduct relating to the importation into the
United States of any drug or controlled substance.
    On February 12, 2021, Ms. Momin was convicted, as defined in
section 306(l)(1) of the FD&C Act, in the U.S. District Court for the
District of Georgia, Rome Division, when the court entered judgment
against her for the offense of conspiracy, in violation of 18 U.S.C.
371.
    FDA's finding that debarment is appropriate is based on the felony
conviction referenced herein. The factual basis for this conviction is
as follows:
    As contained in the Information in Ms. Momin's case, filed on
September 23, 2020, to which she pleaded guilty, between August 2014
and November 2018, Ms. Momin along with her co-conspirators, illegally
imported misbranded drugs from China that she marketed for male
enhancement under names such as ``Black Ant King,'' ``Bull,'' ``Rhino
7,'' ``Super Hard,'' ``Herb Viagra,'' ``Jack Rabbit,'' ``Zhen Gongfu,''
``Stree Overlord,'' ``Pro Power Max,'' ``A Traditional Chinese
Medicine-Kidney Reinforcing Pallet,'' ``Libigrow,'' ``Red Mamba,''
``Rhino 69,'' ``Krazzy Rhino,'' ``Rhino 25,'' Hard Steel,'' and ``Black
Mamba.'' These products contained sildenafil, the active pharmaceutical
ingredient in Pfizer, Inc.'s FDA-approved erectile dysfunction drug,
VIAGRA, and/or tadalafil, the active pharmaceutical ingredient in Eli
Lilly & Company's FDA-approved erectile dysfunction drug, CIALIS. Both
VIAGRA and CIALIS can be obtained in the United States only with a
prescription from a practitioner licensed by law to administer such
drug pursuant to section 503(b) of the FD&C Act (21 U.S.C. 353(b)). In
order to evade U.S. import restrictions, Ms. Momin illegally imported
misbranded drugs into the United States from China. As per the
conspiracy Ms. Momin was involved in, the U.S. Customs declarations on
the boxes containing the misbranded drugs falsely declared the contents
of the boxes to be something other than misbranded drugs, such as
beauty products and health products, to make it appear that the boxes
contained items that could legally be imported into the United States
Ms. Momin then introduced and delivered for introduction into
interstate commerce these misbranded drugs containing undeclared
sildenafil and tadalafil, in violation of sections 301(a), 301(c),
303(a)(2), 502(a), and 502(f) of the FD&C Act (21 U.S.C. 331(a),
331(c), 333(a)(2), 352(a) and 352(f)).
    As a result of this conviction, FDA sent Ms. Momin, by certified
mail, on November 19, 2021, a notice proposing to debar her for a 5-
year period from importing or offering for import any drug into the
United States. The proposal was based on a finding under section
306(b)(3)(C) of the FD&C Act that Ms. Momin's felony conviction under
Federal law for conspiracy, in violation of 18 U.S.C. 371, was for
conduct relating to the importation into the United States of any drug
or controlled substance because she illegally imported and then
introduced misbranded tadalafil and sildenafil into interstate
commerce. In proposing a debarment period, FDA weighed the
considerations set forth in section 306(c)(3) of the FD&C Act that it
considered applicable to Ms. Momin's offense and concluded that the
offense warranted the imposition of a 5-year period of debarment.

    The proposal informed Ms. Momin of the proposed debarment and
offered her an opportunity to request a hearing, providing her 30 days
from the date of receipt of the letter in which to file the request,
and advised her that failure to request a hearing constituted a waiver
of the opportunity for a hearing and of any contentions concerning this
action. Ms. Momin received the proposal and notice of opportunity for a
hearing at her residence on November 26, 2021. Ms. Momin failed to
request a hearing within the timeframe prescribed by regulation and
has, therefore, waived her opportunity for a hearing and waived any
contentions concerning her debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Ms. Shiba
I. Momin has been convicted of a felony under Federal law for conduct
relating to the importation into the United States of any drug or
controlled substance. FDA finds that the offense should be accorded a
debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of
the FD&C Act.
    As a result of the foregoing finding, Ms. Momin is debarred for a
period of 5 years from importing or offering for import any drug into
the United States, effective (see DATES). Pursuant to section 301(cc)
of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for
import into the United States of any drug or controlled substance by,
with the assistance of, or at the direction of Ms. Momin is a
prohibited act.
    Any application by Ms. Momin for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2021-N-0417 and sent to the Dockets Management Staff (see
ADDRESSES). The public availability of information in these submissions
is governed by 21 CFR 10.20(j).
    Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday,<PHONE_NUMBER>.

    Dated: March 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-06036 Filed 3-21-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 118 (Thursday, June 19, 2014)]
[Notices]
[Page 35157]
[FR Doc No: 2014-14282]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

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

    Docket Numbers: EC14-90-000.
    Applicants: SunEdison LLC.
    Description: Supplement to May 23, 2014 Joint Application for
approval of SunEdison LLC and AES U.S. Solar, LLC under Section 203 of
the Fed Power Act under.
    Filed Date: 6/10/14.
    Accession Number: 20140610-5247.
    Comments Due: 5 p.m. ET 6/19/14.

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

    Docket Numbers: ER14-1792-001.
    Applicants: Pinnacle Power, LLC.
    Description: Amendment to MBR Application of Pinnacle Power, LLC to
be effective 6/1/2014.
    Filed Date: 6/11/14.
    Accession Number: 20140611-5137.
    Comments Due: 5 p.m. ET 7/2/14.

    Docket Numbers: ER14-2107-001.
    Applicants: Southwest Power Pool, Inc.
    Description: 1148R18 Substitute American Electric Power Corp. NITSA
NOA to be effective 5/1/2014.
    Filed Date: 6/11/14.
    Accession Number: 20140611-5159.
    Comments Due: 5 p.m. ET 7/2/14.

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

    Dated: June 11, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-14282 Filed 6-18-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Notices]
[Pages 6008-6009]
[FR Doc No: 2018-02772]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

February 6, 2018.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Number: PR18-27-000.
    Applicants: NorthWestern Corporation.
    Description: Tariff filing per 284.123(b),(e)/: Revised Rate
Schedules for Transportation and Storage Service (D2017.11.86) to be
effective 1/1/2018; Filing Type: 980.
    Filed Date: 1/31/18.
    Accession Number:<PHONE_NUMBER>68.
    Comments/Protests Due: 5 p.m. ET 2/21/18.

    Docket Numbers: RP17-913-002.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Compliance filing Compliance Filing.
    Filed Date: 2/1/18.
    Accession Number: 20180201-5112.
    Comments Due: 5 p.m. ET 2/13/18.

    Docket Numbers: RP18-408-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20180201 Annual PRA to be
effective 4/1/2018.
    Filed Date: 2/1/18.
    Accession Number: 20180201-5041.
    Comments Due: 5 p.m. ET 2/13/18.

    Docket Numbers: RP18-409-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Amendment to Neg Rate Agmt
(FPL 41619-17) to be effective 2/1/2018.
    Filed Date: 2/1/18.
    Accession Number: 20180201-5071.
    Comments Due: 5 p.m. ET 2/13/18.

    Docket Numbers: RP18-410-000.
    Applicants: Gulf South Pipeline Company, LP.

    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmt (Pivotal
34691 to Sequent 49016) to be effective 2/1/2018.
    Filed Date: 2/1/18.
    Accession Number: 20180201-5074.
    Comments Due: 5 p.m. ET 2/13/18.

    Docket Numbers: RP18-411-000.
    Applicants: Gulf Crossing Pipeline Company LLC.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmt
(Newfield 18 to SW Energy 1945) to be effective 2/2/2018.
    Filed Date: 2/1/18.
    Accession Number: 20180201-5088.
    Comments Due: 5 p.m. ET 2/13/18.

    Docket Numbers: RP18-412-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Volume No. 2--Neg Rate
Nonconforming Mitsui Co Cameron LNG SP326297 to be effective 3/1/2018.
    Filed Date: 2/1/18.
    Accession Number: 20180201-5107.
    Comments Due: 5 p.m. ET 2/13/18.

    Docket Numbers: RP18-413-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Neg Rate Agmt (DTE 41614) to
be effective 2/1/2018.
    Filed Date: 2/1/18.
    Accession Number: 20180201-5111.
    Comments Due: 5 p.m. ET 2/13/18.

    Docket Numbers: RP18-414-000.
    Applicants: Great Lakes Gas Transmission Limited Par.
    Description: Great Lakes Gas Transmission Limited Partnership
submits its Semi-Annual Transporter's Use Report under RP18-414.
    Filed Date: 1/31/18.
    Accession Number: 20180131-5294.
    Comments Due: 5 p.m. ET 2/12/18.

    Docket Numbers: RP18-416-000.
    Applicants: Viking Gas Transmission Company.
    Description: Sec.  4(d) Rate Filing: Update to Title Page
Negotiated Rate Agreements to be effective 3/2/2018.
    Filed Date: 2/2/18.
    Accession Number: 20180202-5082.
    Comments Due: 5 p.m. ET 2/14/18.

    Docket Numbers: RP18-417-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Sec.  4(d) Rate Filing: TPC Administrative Filing to
be effective 3/5/2018.
    Filed Date: 2/2/18.
    Accession Number: 20180202-5119.
    Comments Due: 5 p.m. ET 2/14/18.

    Docket Numbers: RP18-418-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Neg Rate 2018-02-02 BP, CP to
be effective 2/3/2018.
    Filed Date: 2/2/18.
    Accession Number: 20180202-5165.
    Comments Due: 5 p.m. ET 2/14/18.

    Docket Numbers: RP18-419-000.
    Applicants: Dominion Energy Cove Point LNG, LP.
    Description: Sec.  4(d) Rate Filing: DECP--Liquefaction Project
(CP13-113) Services, Neg. Rates, & Nonconforming SAs to be effective 3/
5/2018.
    Filed Date: 2/2/18.
    Accession Number: 20180202-5189.
    Comments Due: 5 p.m. ET 2/14/18.

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

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-02772 Filed 2-9-18; 8:45 am]
 BILLING CODE 6717-01-P