[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Rules and Regulations]
[Pages 51351-51354]
[FR Doc No: 2020-18405]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2020-0245]
RIN 1625-AA08

Special Local Regulation; Potomac River, Between Jones Point, VA,
and National Harbor, MD

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary special local
regulation for certain waters of the Potomac River. This action is
necessary to provide for the safety of life on these navigable waters
located at Washington, DC, during a swim event on August 23, 2020. This
rule will prohibit persons and vessels from entering the regulated area
unless authorized by the Captain of the Port Maryland-National Capital
Region or the Coast Guard Patrol Commander.

DATES: This rule is effective from 6:30 a.m. to 11 a.m. on August 23,
2020.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2020-0245 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 on this rule,
call or email Mr. Ron Houck, U.S. Coast Guard Sector Maryland-National
Capital Region; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
PATCOM Coast Guard Patrol Commander
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)
with respect to this rule because an NPRM would be impracticable and
contrary to the public interest. On April 20, 2020, WaveOne Open Water
of Washington, DC, notified the Coast Guard that it will be conducting
``Washington's Crossing: Swim Across the Potomac'' from 7:30 a.m. to 10
a.m. on August 23, 2020. The swim event consists of approximately 175
participating swimmers competing on a designated, marked course located
in National Harbor on the Potomac River, downriver of the Wilson Bridge
in Washington, DC. We must establish this safety zone by August 23,
2020, to ensure the safety of particpants and nearby waterway users.
Hazards from the swim competition include participants swimming within
and adjacent to the designated navigation channel and interfering with
vessels intending to operate within that channel, as well as swimming
within approaches to local public and private marinas and public boat
facilities.
    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 impracticable and contrary to the public interest
because immediate action is needed to respond to the potential safety
hazards associated with the ``Washington's Crossing: Swim Across the
Potomac'' event.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector
Maryland-National Capital Region (COTP) has determined that potential
hazards associated with the swim event to be held August 23, 2020, will
be a safety concern for anyone intending to participate in the event
and for vessels that operate within and near the specified waters of
the Potomac River. The purpose of this rule is to ensure the safety of
vessels and the navigable waters in the regulated area before, during
and after the scheduled event.

IV. Discussion of the Rule

    This rule establishes a special local regulation from 6:30 a.m. to
11 a.m. on August 23, 2020. The special local regulation will cover all
navigable waters of the Potomac River, encompassed by a line connecting
the following points, beginning at Jones Point Park, VA, shoreline at
latitude 38[deg]47'35'' N, longitude 077[deg]02'22'' W, thence east
along the northern extent of the Woodrow Wilson Memorial (I-495/I-95)
Bridge, at mile 103.8, to the Rosilie Island shoreline at latitude
38[deg]47'36'' N, longitude 077[deg]01'32'' W, thence south along the
Maryland shoreline to latitude 38[deg]46'52'' N, longitude
077[deg]01'13'' W, at National Harbor, MD shoreline, thence west across
the Potomac River to the George Washington Memorial Parkway highway
overpass and Cameron Run shoreline at latitude 38[deg]47'23'' N,
longitude 077[deg]03'03'' W, thence north along the Virginia shoreline
to the point of origin. The duration of the zone is intended to ensure
the safety of vessels and these navigable waters before, during, and
after the scheduled 7:30 a.m. to 10 a.m. swim event. No vessel or
person will be permitted to enter the regulated area without obtaining
permission from the COTP or a designated representative.

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 13771 directs agencies to control
regulatory costs through a budgeting process. 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), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on size, location and
duration of the regulated area, which would impact a small designated
area of the Potomac River for less than 5 hours. The Coast Guard will
issue a Broadcast Notice to Mariners via VHF-FM Marine Channel 16 about
the status of the regulated area. Moreover, the rule will allow vessels
and persons to seek permission to enter the regulated area.

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
regulated area 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 rule involves
implementation of regulations within 33 CFR part 100 applicable to
organized marine events on the navigable waters of the United States
that could negatively impact the safety of waterway users and shore
side activities in the event area for less than 5 hours. 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.T05-0245 to read as follows:

Sec.  100.T05-0245  Washington's Crossing: Swim Across the Potomac,
Potomac River, National Harbor, MD.

    (a) Regulated area. The regulations in this section apply to the
following area: All navigable waters of the Potomac River, encompassed
by a line connecting the following points, beginning at Jones Point
Park, VA, shoreline at latitude 38[deg]47'35'' N, longitude
077[deg]02'22'' W, thence east along the northern extent of the Woodrow
Wilson Memorial (I-495/I-95) Bridge, at mile 103.8, to the Rosilie
Island shoreline at latitude 38[deg]47'36'' N, longitude
077[deg]01'32'' W, thence south along the Maryland shoreline to
latitude 38[deg]46'52'' N, longitude 077[deg]01'13'' W, at National
Harbor, MD shoreline, thence west across the Potomac River to the
George Washington Memorial Parkway highway overpass and Cameron Run
shoreline at latitude 38[deg]47'23'' N, longitude 077[deg]03'03'' W,
thence north along the Virginia shoreline to the point of origin. These
coordinates are based on datum NAD 1983.
    (b) Definitions. As used in this section--
    Captain of the Port (COTP) Maryland-National Capital Region means
the Commander, U.S. Coast Guard Sector Maryland-National Capital Region
or any Coast Guard commissioned, warrant or petty officer who has been
authorized by the COTP to act on his behalf.
    Coast Guard Patrol Commander (PATCOM) means a commissioned,
warrant, or petty officer of the U.S. Coast Guard who has been
designated by the Commander, Coast Guard Sector Maryland-National
Capital Region.
    Official Patrol means any vessel assigned or approved by Commander,
Coast Guard Sector Maryland-National Capital Region with a
commissioned, warrant, or petty officer on board and displaying a Coast
Guard ensign.
    Participant means all persons and vessels registered with the event
sponsor as participating in the ``Washington's Crossing: Swim Across
the Potomac'' swim event, or otherwise designated by the event sponsor
as having a function tied to the event.
    (c) Regulations. (1) Except for participants and vessels already at
berth, all non-participants are prohibited from entering, transiting

through, anchoring in, or remaining within the regulated area described
in paragraph (a) of this section unless authorized by the COTP
Maryland-National Capital Region or PATCOM.
    (2) To seek permission to enter, contact the COTP Maryland-National
Capital Region at telephone number<PHONE_NUMBER> or on Marine Band
Radio, VHF-FM channel 16 (156.8 MHz) or the PATCOM on Marine Band
Radio, VHF-FM channel 16 (156.8 MHz). If permission is granted, the
non-participant may enter the regulated area or must pass directly
through the regulated area as instructed by PATCOM. A vessel within the
regulated area must operate at safe speed that minimizes wake. Those in
the regulated area must comply with all lawful orders or directions
given to them by the COTP Maryland-National Capital Region or PATCOM.
    (3) The COTP Maryland-National Capital Region will provide notice
of the regulated area through advanced notice via Fifth Coast Guard
District Local Notice to Mariners, broadcast notice to mariners, and
on-scene official patrols.
    (d) Enforcement officials. The Coast Guard may be assisted with
marine event patrol and enforcement of the regulated area by other
federal, state, and local agencies.
    (e) Enforcement period. This section will be enforced from 6:30
a.m. through 11 a.m. on August 23, 2020.

    Dated: August 17, 2020.
Joseph B. Loring,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2020-18405 Filed 8-19-20; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Notices]
[Pages 31933-31934]
[FR Doc No: 2014-12711]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

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

    Docket Numbers: ER14-1388-001.
    Applicants: El Paso Electric Company.
    Description: OATT Revisions to Reflect Palo Verde Index Pricing for
Sch 4 and 9 Imbalances to be effective 5/1/2014.
    Filed Date: 5/22/14.
    Accession Number: 20140522-5078.
    Comments Due: 5 p.m. ET 6/12/14.

    Docket Numbers: ER14-1606-002.
    Applicants: Cosima Energy, LLC.
    Description: 2nd Amended MBR Tariff Filing to be effective 5/1/
2014.
    Filed Date: 5/22/14.
    Accession Number: 20140522-5049.
    Comments Due: 5 p.m. ET 6/12/14.

    Docket Numbers: ER14-1776-001.
    Applicants: Broken Bow Wind II, LLC.
    Description: Broken Bow Wind II, LLC. Market-Based Rates Tariff
Supplement to be effective 7/1/2014.
    Filed Date: 5/21/14.
    Accession Number: 20140521-5180.
    Comments Due: 5 p.m. ET 6/4/14.

    Docket Numbers: ER14-2006-000.
    Applicants: New York Independent System Operator, Inc.
    Description: NYISO compliance re: behind the meter generation to be
effective 12/31/9998.
    Filed Date: 5/21/14.
    Accession Number: 20140521-5187.
    Comments Due: 5 p.m. ET 6/11/14.

    Docket Numbers: ER14-2007-000.
    Applicants: Southern California Edison Company.
    Description: GIA and Distribution Service Agreement with SunEdison
for Pico Rivera Project to be effective 5/23/2014.
    Filed Date: 5/22/14.
    Accession Number: 20140522-5001.
    Comments Due: 5 p.m. ET 6/12/14.

    Docket Numbers: ER14-2008-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Notice of Cancellation of Golden Spread Letter
Agreement of Southwest Power Pool, Inc.
    Filed Date: 5/22/14.
    Accession Number: 20140522-5025.
    Comments Due: 5 p.m. ET 6/12/14.

    Docket Numbers: ER14-2009-000.
    Applicants: Southwest Power Pool, Inc.
    Description: 2562R1 Kansas Municipal Energy Agency NITSA and NOA to
be effective 5/1/2014.
    Filed Date: 5/22/14.
    Accession Number: 20140522-5029.
    Comments Due: 5 p.m. ET 6/12/14.

    Docket Numbers: ER14-2010-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Notice of Cancellation of Original Service Agreement
No. 3089; Queue No. W3-029 to be effective 1/16/2012.
    Filed Date: 5/22/14.
    Accession Number: 20140522-5036.
    Comments Due: 5 p.m. ET 6/12/14.

    Docket Numbers: ER14-2011-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Notice of Cancellation of Original Service Agreement
No. 2931; Queue No. W2-091 to be effective 2/14/2012.
    Filed Date: 5/22/14.
    Accession Number: 20140522-5037.
    Comments Due: 5 p.m. ET 6/12/14.

    Docket Numbers: ER14-2012-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: First Revised Service Agreement No. 3250; Queue No.
W2-091 to be effective 4/30/2014.
    Filed Date: 5/22/14.
    Accession Number: 20140522-5050.
    Comments Due: 5 p.m. ET 6/12/14.

    Docket Numbers: ER14-2013-000.
    Applicants: RJUMR ENERGY PARTNERS CORP.
    Description: RJUMR Energy Partners Corp., FERC Electric Tariff to
be effective 7/1/2014.
    Filed Date: 5/22/14.
    Accession Number: 20140522-5053.
    Comments Due: 5 p.m. ET 6/12/14.

    Docket Numbers: ER14-2014-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Notice of Cancellation of Original Service Agreement
No. 2929; Queue No. W2-088 to be effective 2/14/2012.
    Filed Date: 5/22/14.
    Accession Number: 20140522-5055.
    Comments Due: 5 p.m. ET 6/12/14.

    Docket Numbers: ER14-2015-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: First Revised Service Agreement No. 3249; Queue No.
W2-088 to be effective 4/30/2014.
    Filed Date: 5/22/14.
    Accession Number: 20140522-5083.
    Comments Due: 5 p.m. ET 6/12/14.

    Docket Numbers: ER14-2016-000.
    Applicants: Riverside Energy Center, LLC.
    Description: Cancellation of Tariff to be effective 5/23/2014.
    Filed Date: 5/22/14.
    Accession Number: 20140522-5120.
    Comments Due: 5 p.m. ET 6/12/14.

    Docket Numbers: ER14-2017-000.
    Applicants: California Independent System Operator Corporation.
    Description: 2014-05-22 Full Network Model Tariff Amendment to be
effective 9/8/2014.
    Filed Date: 5/22/14.
    Accession Number: 20140522-5137.
    Comments Due: 5 p.m. ET 6/12/14.

    Docket Numbers: ER14-2018-000.
    Applicants: Golden Spread Electric Cooperative, Inc.

    Description: Pleasant Hill SGIA Second Amendment to be effective 5/
20/2014.
    Filed Date: 5/22/14.
    Accession Number: 20140522-5138.
    Comments Due: 5 p.m. ET 6/12/14.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF14-142-000.
    Applicants: ACB Energy Partners, LLC.
    Description: FERC Form 556 Notice of Certification of Qualifying
Facility Status for a Small Power Production or Cogeneration Facility.
    Filed Date: 12/11/13.
    Accession Number: 20131211-5173.
    Comments Due: None Applicable.

    Docket Numbers: QF14-222-000.
    Applicants: North Davis Sewer District.
    Description: FERC Form 556 Notice of Certification of Qualifying
Facility Status for a Small Power Production or Cogeneration Facility.
    Filed Date: 1/6/14.
    Accession Number: 20140106-5170.
    Comments Due: None Applicable.

    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: May 22, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-12711 Filed 6-2-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Notices]
[Pages 13068-13069]
[FR Doc No: 2013-04389]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0714]

Richard Stowell: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The U.S. Food and Drug Administration (FDA) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
debarring Richard Stowell for a period of 3 years from importing
articles of food or offering such articles for importation into the
United States. FDA bases this order on a finding that Mr. Stowell was
convicted, as defined in section 306(l)(1)(B) of the FD&C Act (21
U.S.C. 335a(l)(1)(B)), of three felony counts under Federal law for
conduct relating to the importation into the United States of an
article of food. Mr. Stowell was given notice of the proposed debarment
and an opportunity to request a hearing within the timeframe prescribed
by regulation. As of December 14, 2012, Mr. Stowell had not responded.
Mr. Stowell's failure to respond constitutes a waiver of his right to a
hearing concerning this action.

DATES: This order is effective February 26, 2013.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville,
MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C))
permits FDA to debar an individual from importing an article of food or
offering such an article for import into the United States if FDA
finds, as required by section 306(b)(3)(A) of the FD&C Act (21 U.S.C.
335a(b)(3)(A)), that the individual has been convicted of a felony for
conduct relating to the importation into the United States of any food.
    On July 27, 2011, Mr. Stowell was convicted, as defined in section
306(l)(1)(B) of the FD&C Act, when the U.S. District Court for the
Southern District of Florida accepted his plea of guilty and entered
judgment against him for the following offenses: One count of
conspiracy to falsely label and misbrand seafood, in violation of 18
U.S.C. 371; one count of false labeling of seafood under the Lacey Act,
in violation of 16 U.S.C. 3372(d)(2) and 3373(d)(3)(A)(ii); and one
count of misbranding food, in violation of 21 U.S.C. 331(a), 343(a)(1),
and 333(a)(2).
    FDA's finding that debarment is appropriate is based on the felony

convictions referenced herein for conduct relating to the importation
into the United States of any food. The factual basis for these
convictions is as follows: Mr. Stowell was the president and sole
shareholder of United Seafood Imports, Inc. (United), a Florida based
seafood wholesaler engaged in various aspects of purchasing, importing,
processing, packing, selling, and exporting seafood products, including
shrimp.
    Beginning in or around January 25, 2007, and continuing through on
or about August 7, 2009, Mr. Stowell did knowingly and with the intent
to further the object of a conspiracy combine, conspire, confederate,
and agree with others to commit an offense against the United States.
Specifically, Mr. Stowell's company United purchased approximately one
million pounds of shrimp in boxes labeled ``Shrimp, Product of
Thailand,'' ``Shrimp, Product of Malaysia,'' and ``Shrimp, Product of
Indonesia.'' Mr. Stowell then sent the shrimp to another company,
Shifco, and instructed them to repackage and relabel the shrimp as
``Shrimp, Product of Panama,'' ``Shrimp, Product of Ecuador,'' and
``Shrimp, Product of Honduras.'' United, and employees under Mr.
Stowell's direction and control, managed and directed the labeling
operations of Shifco by providing instructions and other directives to
them. Mr. Stowell's company then sold the shrimp that was relabeled to
a company who in turn subsequently sold the shrimp to a supermarket
chain. This was in violation of 18 U.S.C. 371.
    On or about January 26, 2007, Mr. Stowell purchased 180 cases of
shrimp valued at approximately $24,912 and knowingly created and caused
to be created individual labels, preprinted bags, and other documents
falsely identifying the shrimp as being ``Shrimp, Product of Ecuador,''
when in truth and in fact he knew the shrimp was a product of Malaysia.
This was in violation of 16 U.S.C. 3372(d)(2) and 3373(d)(3)(A)(ii).
    On or about July 2, 2009, Mr. Stowell knowingly engaged in an
offense that involved the introduction and delivery for introduction
into interstate commerce of a food that was misbranded, that is,
approximately 52 cases of shrimp, with the intent to defraud or
mislead, in that Mr. Stowell created and caused to be created
individual labels, preprinted bags, and other documents falsely
identifying the shrimp as being a product of Panama when in truth and
in fact, he knew the shrimp was a product of Indonesia. This was in
violation of 21 U.S.C. 331(a), 333(a)(2), and 343(a)(1).
    As a result of his conviction, on September 24, 2012, FDA sent Mr.
Stowell a notice by certified mail proposing to debar him for a period
of 3 years from importing articles of food or offering such articles
for import into the United States. The proposal was based on a finding
under section 306(b)(1)(C) of the FD&C Act that Mr. Stowell was
convicted of three felony counts under Federal law for conduct relating
to the importation into the United States of an article of food because
he: Conspired to falsely label and misbrand seafood, falsely labeled
seafood under the Lacey Act, and misbranded food.
    The proposal was also based on a determination, after consideration
of the factors set forth in section 306(c)(3) of the FD&C Act (21
U.S.C. 335a(c)(3)) that Mr. Stowell should be subject to a 3-year
period of debarment. The proposal also offered Mr. Stowell an
opportunity to request a hearing, providing him 30 days from the date
of receipt of the letter in which to file the request, and advised him
that failure to request a hearing constituted a waiver of the
opportunity for a hearing and of any contentions concerning this
action. Mr. Stowell failed to request a hearing within the timeframe
prescribed by regulation and has, therefore, waived his opportunity for
a hearing and waived any contentions concerning his debarment (21 CFR
part 12).

II. Findings and Order

    Therefore, the Associate Commissioner for Regulatory Affairs,
Office of Regulatory Affairs, under section 306(b)(1)(C) of the FD&C
Act, and under authority delegated to the Associate Commissioner (Staff
Manual Guide 1410.21), finds that Mr. Richard Stowell has been
convicted of three felony counts under Federal law for conduct relating
to the importation of an article of food into the United States and
that he is subject to a 3-year period of debarment.
    As a result of the foregoing finding, Mr. Stowell is debarred for a
period of 3 years from importing articles of food or offering such
articles for import 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 an article
of food by, with the assistance of, or at the direction of Mr. Stowell
is a prohibited act.
    Any application by Mr. Stowell for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2012-N-0714 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 8, 2013.
Melinda K. Plaisier,
Acting Associate Commissioner for Regulatory Affairs, Office of
Regulatory Affairs.
[FR Doc. 2013-04389 Filed 2-25-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: October 9, 2007 (Volume 72, Number 194)]
[Notices]
[Page 57318-57319]
[DOCID:fr09oc07-64]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

October 1, 2007.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP05-164-011.
    Applicants: Equitrans, LP.
    Description: Equitrans LP submits Twenty-Eight Revised Sheet 6 to
its FERC Gas Tariff, First Revised Volume 1, effective 11/1/07.
    Filed Date: 09/28/2007.
    Accession Number: 20071001-0027.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 10, 2007.

    Docket Numbers: RP07-713-000.
    Applicants: Dominion Transmission, Inc.
    Description: Dominion Transmission Inc submits Thirty-Fourth
Revised Sheet 31 et al. to its FERC Gas Tariff, Third Revised Volume 1,
to become effective 11/1/07.
    Filed Date: 09/28/2007.
    Accession Number: 20071001-0026.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 10, 2007.

    Docket Numbers: RP07-714-000.
    Applicants: Destin Pipeline Company, L.L.C.
    Description: Destin Pipeline Company LLC submits Third Revised
Sheet 258 to its FERC Gas Tariff, Volume 1, to become effective 11/1/
07.
    Filed Date: 09/28/2007.
    Accession Number: 20071001-0025.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 10, 2007.

    Docket Numbers: RP07-715-000.
    Applicants: Liberty Gas Storage, LLC.
    Description: Liberty Gas Storage LLC submits First Revised Sheet
153 et al. to its FERC Gas Tariff, Original Volume 1.
    Filed Date: 09/28/2007.
    Accession Number: 20071001-0024.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 10, 2007.

    Docket Numbers: RP07-716-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Iroquois Gas Transmission System LP submits a report
relating to its Deferred Asset Surcharge.
    Filed Date: 09/28/2007.
    Accession Number: 20071001-0030.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 10, 2007.

    Docket Numbers: RP07-717-000.
    Applicants: Dominion Transmission, Inc.
    Description: Dominion Transmission Inc submits Thirty-Third Revised
Sheet 31 et al. to its FERC Gas Tariff, Third Revised Volume 1, to
become effective 11/1/07.
    Filed Date: 09/28/2007.
    Accession Number: 20071001-0029.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 10, 2007.

    Docket Numbers: RP97-81-042.
    Applicants: Kinder Morgan Interstate Gas Trans. LLC.
    Description: Kinder Morgan Interstate Gas Transmission LLC submits
Seventeenth Revised Sheet 4G.01 et al. to its FERC Gas Tariff, Fourth
Revised Volume 1-A, to become effective 10/1/07.
    Filed Date: 09/28/2007.
    Accession Number: 20071001-0028.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 10, 2007.

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

access

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

Nathaniel J. Davis, Sr.,
Acting Deputy Secretary.
 [FR Doc. E7-19728 Filed 10-5-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Notices]
[Pages 36149-36150]
[FR Doc No: 2017-16380]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2489]

Receipt of Notice That a Patent Infringement Complaint Was Filed
Against a Biosimilar Applicant

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing notice
that an applicant for a proposed biosimilar product notified FDA that a
patent infringement action was filed in connection with the applicant's
biologics license application (BLA). Under the Public Health Service
Act (PHS Act), an applicant for a proposed biosimilar product or
interchangeable product must notify FDA within 30 days after the
applicant was served with a complaint in a patent infringement action
described under the PHS Act. FDA is required to publish notice of the
complaint in the Federal Register.

FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6246, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) was enacted as part of the Patient
Protection and Affordable Care Act (Pub. L. 111-148) on March 23, 2010.
The BPCI Act amended the PHS Act and created an abbreviated licensure
pathway for biological products shown to be biosimilar to, or
interchangeable with, an FDA-licensed biological reference product.
Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by the BPCI
Act, describes the requirements for a BLA for a proposed biosimilar
product or a proposed interchangeable product (351(k) BLA). Section
351(l) of the PHS Act, also added by the BPCI Act, describes certain
procedures for exchanging patent information and resolving patent
disputes between a 351(k) BLA applicant and the holder of the BLA
reference product. If a 351(k) applicant is served with a complaint for
a patent infringement described in section 351(l)(6) of the PHS Act,
the applicant is required to provide FDA with notice and a copy of the
complaint within 30 days of service. FDA is required to publish notice
of a complaint received under section 351(l)(6)(C) of the PHS Act in
the Federal Register.
    FDA received notice of the following complaint under section
351(l)(6)(C) of the PHS Act: Amgen, Inc., et al. v. Coherus
Biosciences, Inc., 17-cv-00546 (D. Del., filed May 10, 2017).
    FDA has only a ministerial role in publishing notice of a complaint
received under section 351(l)(6)(C) of the PHS Act and does not perform
a substantive review of the complaint.

    Dated: July 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16380 Filed 8-2-17; 8:45 am]
BILLING CODE 4164-01-P


 EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

J.R. Simplot Company

EPA Reg. #8917

       EPA has received a pesticide petition #5F8425, from J.R. Simplot Company, 5369
W. Irving St., Boise, ID 83706 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an amendment/expansion of an existing tolerance exemption for the plant pesticide the VNTl protein product of the Rpi-vntl  gene in or on potato. Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, J.R. Simplot Company has submitted the following summary of information , data, and arguments in support of their pesticide petition. This summary was prepared by J.R. Simplot Company and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by
EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.

 I. J.R. Simplot Company Petition Summary

   #5F8425

 Product Name and Proposed Use Practices

 The W8 Russet Burbank, X17 Ranger Russet, and Y9 Atlantic Potato varieties, containing the VNTl protein. The VNT l protein is expressed from the Rpi-vntl  gene originating from Solanum venturii and confers resistance to Phytophthora infestans, the cause of late blight disease in potato.

 Product Identity/ Chemistry

       Identity of the pesticide and corresponding residues.

The active ingredient that provides late blight resistance in potato is the VNTl protein produced from the Rpi-vntl  resistance gene from Solanum venturii.

 Name: Rpi-vntl  Resistance Gene and VNTl protein.

 Chemical Identity: Nucleic acid (including promoter, coding sequence, and terminator) and translated amino acid polypeptide.

        Composition: Potato events were generated by Agrobacterium-mediated plant transformation. Confirmation of gene insertion was carried out using PCR, Southern blot, and immunoblot methods based on the gene and protein sequences.

 Magnitude of residues at the time of harvest and method used to determine the residue.

 Less than 100 ppb in tubers as determined by immunoblot detection. It is estimated that the active ingredient, VNTl protein, is less than 0.00001% of potato.

 A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed.

 The VNTl protein concentration is less than 100 ppb in tubers. As the expression levels of the VNTl protein are below detection limits it is impractical to demonstrate methods for detecting and measuring the levels of the pesticide residues.

 C. Mammalian Toxicological Profile

 Assessments of the VNTl protein and Rpi-vntl resistance gene were carried out to determine the mode of action, history of safe use, similarity to known toxins or allergens, and expression levels inplanta. No safety concerns of the VNTl  protein were identified.

 Proteins are not inherently toxic and are rapidly denatured by the acidic conditions of the stomach and by proteases secreted in the intestinal tract.

 Resistance genes (R-genes) have a non-toxic mode of action and are found in multiple plant species, including: Solanum melongena L. (eggplant), Capsicum annum L. (pepper), S. lycopersicum L. (tomato), S. tuberosum L. (potato), Zea mays (maize), Glycine max (soybean), Oryza saliva L. (rice), and Triticum aestivum L. (wheat). R-genes are an important part of a plants immune response to pathogen infection. They are protein receptors that recognize and bind pathogen-secreted proteins. Upon pathogen recognition, a form of programmed cell death is activated causing infected plant cells to die, blocking the spread of infection.

 A NCBI database search for homologs of the VNTl protein and the Rpi-vntl gene identified potato and tomato genes with high sequence similarity. An example is the tomato gene Tm-22, which provides resistance to the tomato mosaic virus (TMV), and is 90% similar to Rpi-vntl in nucleic acid sequence. The encoded proteins Tm-22  and VNTl are 75% identical in amino acid sequence. A search of tomato variety databases and retail websites show seventy-eight varieties and two rootstocks of TMV resistant tomato. These examples demonstrate a history of safe use for proteins similar to VNTl.

 A bioinformatics analysis showed no sequence similarity between the VNTl protein or any known allergen or toxin demonstrating a low hazard to humans.

 A sensitive immunoblot method was used to determine that the VNTl protein is expressed at less than 100 ppb in tubers. It is estimated that the active ingredient, VNTl protein, is less than 0.00001% of potato. Effects on humans and on non-target organisms, including plants, insects, mammals, birds, and aquatic life would be negligible because of the lack of exposure.

 Aggregate Exposure

 Dietary exposure.

 The VNTl protein is similar to other proteins to which people are exposed in their diet without adverse effects. Because of the low expression levels of the VNTl protein
 the exposure to humans is negligible.

       i.Food.

 The VNTl protein is expressed in potato. Human exposure is expected from eating potato. The VNTl protein is not similar to any known allergens or toxins. The VNTl protein is expressed at low levels. The low hazard and low exposure minimizes risk associated with the VNTl protein.

       ii. Drinking water.

       Human exposure is not expected through drinking water.

        Non-dietary exposure.

 The VNTl protein is a plant-incorporated protectant. Other uses where human exposure might occur are not intended or expected.

 E. Cumulative Effects

 Human exposure to the VNTl protein from diet, food, drinking water, or other occupational or residential use is negligible.

 Safety Determination

 U.S. population.

 The VNTl protein is unlikely to pose risk to human health. Study reports assessing the safety of the VNTl protein demonstrate a non-toxic mode of action for the VNTl protein, a history of safe use for homologous proteins in potato and tomato, and no

 significant sequence similarities between VNTI  and known allergens or toxins. The VNTl protein concentration was shown to be less than 100 ppb in tubers. Defining a tolerance limit for the VNTl protein is not practical considering the low expression and low exposure risk of the VNTl protein.

        Infants and children.

       The VNTl protein is unlikely to pose risk to infants or children.

 G. Effects on the Immune and Endocrine Systems

 The VNTI protein is unlikely to cause effects on the immune and endocrine systems.

 H  Existing Tolerances

 A current temporary exemption from the requirement of a tolerance [EPA-HQ OPP-2014-0457; FRL-9922-53] established for residues of the VNTl protein in potato expires on December 31, 2015. An extension for the temporary tolerance is currently under review  (508375).

 I. International Tolerances

       None.


[Federal Register Volume 87, Number 224 (Tuesday, November 22, 2022)]
[Notices]
[Pages 71334-71335]
[FR Doc No: 2022-25405]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2841]

Science Board to the Food and Drug Administration Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Science Board to
the Food and Drug Administration (Science Board). The Science Board
provides advice to the Commissioner of Food and Drugs and other
appropriate officials on specific, complex scientific and technical
issues important to FDA and its mission, including emerging issues
within the scientific community. Additionally, the Science Board
provides advice to the Agency on keeping pace with technical and
scientific developments, including in regulatory science, input into
the Agency's research agenda, and on upgrading its scientific and
research facilities and training opportunities. It will also provide,
where requested, expert review of Agency-sponsored intramural and
extramural scientific research programs. The meeting will be open to
the public.

DATES: The meeting will be held virtually on December 8, 2022, from 9
a.m. to 4 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the
Chief Scientist, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3309, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected], or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. The Science
Board will consider research needs for the evaluation of potential
adverse health effects in children associated with oral cadmium
exposure. The Science Board will also hear about the Agency's cross-
cutting regulatory science research activities and its recent Focus
Areas of Regulatory Science report.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference meeting room will be available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
December 2, 2022. Oral presentations from the public will be scheduled
between approximately 11 a.m. and 12 p.m. Those individuals interested
in making formal oral presentations should notify the contact person
and submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before December 1, 2022. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by December 2, 2022.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Rakesh Raghuwanshi (see FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: November 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25405 Filed 11-21-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: February 24, 2009 (Volume 74, Number 35)]
[Rules and Regulations]
[Page 8200]
[DOCID:fr24fe09-21]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 17

[Docket No. FDA-2008-N-0561]

Maximum Civil Money Penalty Amounts and Compliance With the
Federal Civil Penalties Inflation Adjustment Act; Confirmation of
Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

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

SUMMARY: The Food and Drug Administration (FDA) is confirming the
effective date of March 27, 2009, for the direct final rule that
appeared in the Federal Register of November 12, 2008 (73 FR 66750).
The direct final rule amends the agency's regulations to update the
statutory citations regarding the new civil monetary penalties
prescribed by the Food and Drug Administration Amendments Act of 2007
(FDAAA), amends the regulations to include the new FDAAA penalties, and
adjusts the preceding maximum civil penalty amounts for inflation as
prescribed by the Federal Civil Penalties Inflation Adjustment Act of
1990 (FCPIAA). This document confirms the effective date of the direct
final rule.

DATES: Effective date confirmed: March 27,2009.

FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy, Food
and Drug Administration, 10903 New Hampshire Ave, Bldg. 1, rm. 4305,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 12, 2008
(73 FR 66750), FDA published the ``Maximum Civil Money Penalty Amounts
and Compliance With the Federal Civil Penalties Inflation Adjustment
Act'' direct final rule and solicited comments concerning the direct
final rule for a 75-day period ending March 27, 2009. The direct final
rule revises Sec.  17.1 (21 CFR 17.1) to update the statutory citations
regarding the new civil monetary penalties prescribed by FDAAA, and
revises the table in Sec.  17.2 (21 CFR 17.2) to include the new FDAAA
penalties, and adjusts the preceding maximum civil penalty amounts for
inflation as prescribed by the FCPIAA. This was accomplished by
revising the list of statutory monetary penalties in Sec.  17.1 to
include the new penalties prescribed by the Federal Food, Drug, and
Cosmetic Act, as amended by FDAAA in 2007. These new penalties have
been added as new paragraphs (c) and (d). The table in Sec.  17.2 also
has been amended to include the new penalties, and the adjusted maximum
penalty amounts for the pre-FDAAA penalties have been updated to
account for the inflation between June 2004 (the year of the last
adjustment) and June 2007 as prescribed by FCPIAA.
    FDA also solicited comments concerning the changes for a 75-day
period ending January 26, 2009, in a proposed rule published in the
Federal Register of November 12, 2008 (73 FR 66811). FDA stated that
the effective date of the direct final rule would be on March 27, 2009,
60 days after the end of the comment period, unless any significant
adverse comment was submitted to FDA during the comment period. FDA did
not receive any significant adverse comments.
    Authority: Therefore, under the Federal Food, Drug, and Cosmetic
Act and the Public Health Service Act, and under authority delegated to
the Commissioner of Food and Drugs, 21 CFR part 17 is amended.
Accordingly, the amendments issued thereby are effective.

    Dated: February 17, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3831 Filed 2-23-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 84, Number 200 (Wednesday, October 16, 2019)]
[Notices]
[Page 55327]
[FR Doc No: 2019-22463]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4458-DR; Docket ID FEMA-2019-0001]

Louisiana; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Louisiana (FEMA-4458-DR), dated August 27, 2019, and
related determinations.

DATES: This amendment was issued September 30, 2019.

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 Louisiana is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of August 27, 2019.

    Lafayette Parish for Public Assistance.
    Livingston, Pointe Coupee, St. Bernard, and St. Martin Parishes
for debris removal and emergency protective measures (Categories A
and B), 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.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-22463 Filed 10-15-19; 8:45 am]
 BILLING CODE 9111-23-P