[Federal Register Volume 85, Number 151 (Wednesday, August 5, 2020)]
[Notices]
[Page 47469]
[FR Doc No: 2020-17027]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2020-0063]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on July 14, 2020, the American
Short Line and Regional Railroad Association (ASLRRA) petitioned the
Federal Railroad Administration (FRA) for a waiver of compliance from
certain provisions of the Federal railroad safety regulations contained
at 49 CFR parts 213, 214, 217, 218, 220, 228, 232, 236, 240, 242, and
243. FRA assigned the petition Docket Number FRA-2020-0063.
    ASLRRA, on behalf of itself and its member railroads, requests to
renew emergency relief to allow for social distancing and workforce
shortages, which was previously granted by FRA by letter dated May 22,
2020, in its emergency relief docket (Docket Number FRA-2020-0002). See
https://www.regulations.gov/document?D=FRA-2020-0002-0072. FRA renewed
this relief for an additional 60 days on July 20, 2020. See https://www.regulations.gov/document?D=FRA-2020-0002-0095.
    ASLRRA also requests relief from the annual continuous welded rail
training requirement at 49 CFR 213.7(c)(2). Short lines have postponed
in-person training due to social distancing requirements, but based on
the rise of coronavirus disease 2019 (COVID-19), it is unlikely that
training will be possible. Additionally, ASLRRA requests clarification
regarding refresher/recurrent training requirements for roadway workers
under 49 CFR 214.343-214.357.
    In support of its petition, ASLRRA states that continuing the
relief to comply with guidance on social distancing from the Centers
for Disease Control and Prevention (CDC) is necessary to protect
railroad employees. ASLRRA further states that extending the relief
will enable railroads and their employees to maintain safe workplace
practices. ASLRRA explains it anticipates needing such relief so long
as CDC guidance recommending social distancing remains in place.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov (Docket Number FRA-2020-0063).
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. If any interested
parties desire an opportunity for oral comment and a public hearing,
they should notify FRA, in writing, before the end of the comment
period and specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by September 4, 2020 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable. Anyone can search the electronic
form of any written communications and comments received into any of
our dockets by the name of the individual submitting the comment (or
signing the document, if submitted on behalf of an association,
business, labor union, etc.). Under 5 U.S.C. 553(c), the U.S.
Department of Transportation (DOT) solicits comments from the public to
better inform its processes. 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 https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2020-17027 Filed 8-4-20; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 84 (Tuesday, May 1, 2012)]
[Rules and Regulations]
[Pages 25591-25592]
[FR Doc No: 2012-10432]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket Number USCG-2012-0226]

Drawbridge Operation Regulation; St. Croix River, Stillwater, MN

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Stillwater Highway Drawbridge
across the St. Croix River, mile 23.4, at Stillwater, Minnesota. The
deviation is necessary to enable completion of repairs to the bridge.
This deviation allows the bridge to be operated on a restricted opening
schedule.

DATES: This deviation is effective from 8:00 a.m. on October 15, 2012
to 7:59 a.m. on December 31, 2012.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2012-0226 and are available online
by going to http://www.regulations.gov, inserting USCG-2012-0226 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Eric A. Washburn, Bridge Administrator, Western Rivers,
Coast Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If
you have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Minnesota Department of Transportation
requested a temporary deviation for the Stillwater Highway Drawbridge,
across the St. Croix River, mile 23.4, at Stillwater, Minnesota to be
operated on a restricted opening schedule from October 15, 2012 until
December 31, 2012; as follows:
    From 8:00 a.m. October 15, 2012 through 7:59 a.m. October 20, 2012,
lift span will remain in the closed-to-navigation position.
    From 8:00 a.m. October 20, 2012, through 5:59 p.m. October 21,
2012, lift span will open with 24-hour advance notice.
    From 6:00 p.m. October 21, 2012, through 7:59 a.m. October 27,
2012, lift span will remain in the closed-to-navigation position.
    From 8:00 a.m. October 27, 2012, through 5:59 p.m. October 28,
2012, lift span will open with 24-hour advance notice.
    From 6:00 p.m. October 28, 2012, through 7:59 a.m. November 3,
2012, lift span will remain in the closed-to-navigation position.

    From 8:00 a.m. November 3, 2012, through 5:59 p.m. November 4,
2012, lift span will open with 24-hour advance notice.
    From 6:00 p.m. November 4, 2012, through 7:59 a.m. December 31,
2012, lift span will remain in the closed-to-navigation position.
    The Stillwater Highway Drawbridge currently operates in accordance
with 33 CFR 117.667(b), which states specific seasonal and commuter
hours operating requirements.
    There are no alternate routes for vessels transiting this section
of the St. Croix River. For emergency vessels, there will be a
contingency plan in place.
    The Stillwater Highway Drawbridge, in the closed-to-navigation
position, provides a vertical clearance of 10.9 feet above normal pool.
Navigation on the waterway primarily consists of commercial
sightseeing/dinner cruise boats and recreational watercraft. This
temporary deviation has been coordinated with waterway users. No
objections were received.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: March 27, 2012.
Eric A. Washburn,
Bridge Administrator, Western Rivers.
[FR Doc. 2012-10432 Filed 4-30-12; 8:45 am]
BILLING CODE 9110-04-P


Comment Info: =================

General Comment:A 75 day comment period is insufficient time for the vaping industry and the wider vaping community to comment on the proposed deeming regulations. I would respectfully request that the period for comment be extended to 180 days. The regulations need to allow for small businesses to thrive in the states. If the current proposed rule is invoked it will ruin jobs for many Americans and remove the possibility for future small businesses to start.


[Federal Register Volume 78, Number 191 (Wednesday, October 2, 2013)]
[Rules and Regulations]
[Pages 60656-60658]
[FR Doc No: 2013-23439]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0352; Directorate Identifier 2012-SW-063-AD;
Amendment 39-17598; AD 2013-19-16]
RIN 2120-AA64

Airworthiness Directives; Sikorsky Aircraft Corporation
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for
Sikorsky Aircraft Corporation (Sikorsky) Model S-92A helicopters to
require modifying the No. 1 engine forward firewall center fire
extinguisher discharge tube (No. 1 engine tube) and inspecting the
outboard discharge tube to determine if it is correctly positioned.
This AD was prompted by the discovery that the No. 1 engine tube
installed on the helicopters is too long to ensure that a fire could be
effectively extinguished in the helicopter. The actions are intended to
ensure the No. 1 engine tube allows for complete coverage of an
extinguishing agent in the No. 1 engine compartment area, ensure that a
fire would be extinguished and prevent the loss of helicopter control.

DATES: This AD is effective November 6, 2013.
    The Director of the Federal Register approved the incorporation by
reference of certain documents listed in this AD as of November 6,
2013.

ADDRESSES: For service information identified in this AD, contact
Sikorsky Aircraft Corporation, Attn: Manager, Commercial Technical
Support, mailstop s581a, 6900 Main Street, Stratford, CT 06614;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>or at http://www.sikorsky.com. You may review a copy of the referenced service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas 76137.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, any incorporated-by-reference
service information, the economic evaluation, any comments received,
and other information. The street address for the Docket Operations
Office (phone:<PHONE_NUMBER>) is U.S. Department of Transportation,
Docket Operations Office, M-30, West Building Ground Floor, Room W12-
140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Michael Schwetz, Aviation Safety
Engineer, Boston Aircraft Certification Office, Engine & Propeller
Directorate, FAA, 12 New England Executive Park, Burlington,
Massachusetts 01803; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On April 22, 2013, at 78 FR 23698, the Federal Register published
our notice of

proposed rulemaking (NPRM), which proposed to amend 14 CFR part 39 by
adding an AD that would apply to Sikorsky Model S-92A helicopters,
serial numbers 920006 through 920169. The NPRM proposed to require
modifying the No. 1 engine tube and inspecting the outboard discharge
tube to determine if it is correctly positioned. The work required to
modify the No.1 engine tube may dislocate the outboard discharge tube,
which directs fire extinguishing agent to a specific area of the engine
compartment. The NPRM was prompted because an extinguishing test at a
Sikorsky plant showed that a No. 1 engine tube with the incorrect
length had been put into production. Because of the incorrect tube
length, the fire-extinguishing system may not discharge the agent
completely throughout the compartment in the event of a fire. The
proposed requirements were intended to ensure the No. 1 engine tube
allows for complete coverage of an extinguishing agent in the No. 1
engine compartment area, ensure that a fire is extinguished and prevent
the loss of helicopter control.

Comments

    We gave the public the opportunity to participate in developing
this AD, but we received no comments on the NPRM (78 FR 23698, April
22, 2013).

FAA's Determination

    We have reviewed the relevant information and determined that an
unsafe condition exists and is likely to exist or develop on other
products of these same type designs and that air safety and the public
interest require adopting the AD requirements as proposed.

Related Service Information

    Sikorsky has issued Alert Service Bulletin 92-26-004 (ASB), dated
June 4, 2012, to modify the No. 1 engine tube within 120 days. The ASB
specifies procedures to cut two inches off the tube's discharge end, as
well as how to inspect and reposition, if necessary, the outboard
discharge tube.

Costs of Compliance

    We estimate that this AD will affect 24 U.S. registered helicopters
and that labor costs average $85 per work-hour. Based on these
estimates, we expect the following costs:
     Modifying the No. 1 engine tube takes 2 work-hours for a
labor cost of $170 per helicopter. No parts are needed, so the cost for
the U.S. fleet totals $4,080.
     Inspecting the outboard discharge tube and ensuring that
it is in the required position takes about 1 work-hour for a total
labor cost of $85 per helicopter. No parts are needed for a total U.S.
fleet cost of $2,040.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    (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);
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction; and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2013-19-16 Sikorsky Aircraft Corporation Helicopters: Amendment 39-
17598; Docket No. FAA-2013-0352; Directorate Identifier 2012-SW-063-
AD.

(a) Applicability

    This AD applies to Sikorsky Aircraft Corporation (Sikorsky)
Model S-92A helicopters, serial numbers 920006 through 920169,
certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as failure of the No. 1
engine forward firewall center fire extinguisher discharge tube to
discharge an extinguishing agent for complete coverage of the No. 1
engine compartment area. This condition could result in a fire not
being extinguished and subsequent loss of helicopter control.

(c) Effective Date

    This AD becomes effective November 6, 2013.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 120 days:
    (1) Modify the No. 1 engine forward firewall center discharge
tube in accordance with the Accomplishment Instructions, Paragraph
B, of Sikorsky Alert Service Bulletin 92-26-004, dated June 4, 2012
(ASB).
    (2) Inspect the outboard discharge tube and determine if it is
correctly positioned as depicted in Figure 3 of the ASB. If it is
not correctly positioned, correct the positioning in accordance with
the Accomplishment Instructions, Paragraph D, of the ASB.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Boston Aircraft Certification Office, FAA, may
approve AMOCs for this AD. Send your proposal to: Michael Schwetz,
Aviation Safety Engineer, Boston Aircraft Certification Office,
Engine & Propeller Directorate, FAA, 12 New England Executive Park,
Burlington, Massachusetts 01803; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or

lacking a principal inspector, the manager of the local flight
standards district office or certificate holding district office
before operating any aircraft complying with this AD through an
AMOC.

(g) Subject

    Joint Aircraft Service Component (JASC) Code: 2620,
Extinguishing System.

(h) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Sikorsky Alert Service Bulletin 92-26-004, dated June 4,
2012.
    (ii) Reserved.
    (3) For Sikorsky service information identified in this AD,
contact Sikorsky Aircraft Corporation, Attn: Manager, Commercial
Technical Support, mailstop s581a, 6900 Main Street, Stratford, CT
06614; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>or
at http://www.sikorsky.com.
    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663,
Fort Worth, Texas 76137. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on September 17, 2013.
Gwendolynne O'Connell,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2013-23439 Filed 10-1-13; 8:45 am]
BILLING CODE 4910-13-P


	 	40CFR302.6 Notification requirements 	Johnson, Alyssa LT  	to: 	Lynn Beasley 	12/16/2010 01:53 PM 	Sent by: <EMAIL_ADDRESS>	Show Details

History:	This message has been replied to and forwarded.

Good Afternoon Ms. Beasley,

Your name was listed as the point of contact for the most recent regulation update to 40 CFR 302.  Please let me know if you are no longer responsible for updating this regulation.  Recently, it was brought to my attention that the contact information for the NRC listed in 40CFR302.6 is incorrect.  The correct NRC contact information is 1-800-424-8802, local phone number<PHONE_NUMBER>, and fax number<PHONE_NUMBER>.  We do not maintain a telefax, and the following phone numbers have been disconnected<PHONE_NUMBER> and<PHONE_NUMBER> (listed fax number).

Please let me know appropriate how long it will take to update the regulations.

Thx, Alyssa

LT Alyssa Johnson National Response Center COMDT CG-5335 Operations Officer Phone:<PHONE_NUMBER>/1-800-424-8802 Fax:<PHONE_NUMBER>


[Federal Register Volume 82, Number 125 (Friday, June 30, 2017)]
[Rules and Regulations]
[Pages 29738-29739]
[FR Doc No: 2017-13841]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2017-0613]

Safety Zone; City of Richmond Fourth of July Fireworks Display,
San Francisco Bay, Richmond, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the safety zone for the annual
City of Richmond Fourth of July Fireworks Display in the Captain of the
Port, San Francisco area of responsibility during the dates and times
noted below. This action is necessary to protect life and property of
the maritime public from the hazards associated with the fireworks
display. During the enforcement period, unauthorized persons or vessels
are prohibited from entering into, transiting through, or anchoring in
the safety zone, unless authorized by the Patrol Commander (PATCOM).

DATES: The regulations in 33 CFR 165.1191, Table 1, Item number 9, will
be enforced from 8 a.m. on July 1, 2017 to 10 p.m. on July 3, 2017.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Lieutenant Junior Grade Christina Ramirez, U.S. Coast
Guard Sector San Francisco; telephone<PHONE_NUMBER> or email at<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce a 100 foot
safety zone around the fireworks barge during the loading, transit, and
arrival of the fireworks barge from the loading location to the display
location and until the start of the fireworks display. From 8 a.m. on
July 1, 2017 until 5 p.m. on July 3, 2017, the fireworks barge will be
loading pyrotechnics from Pier 50 in San Francisco, CA. The fireworks
barge will remain at the loading location until its transit to the
display location. From 6 p.m. to 8:30 p.m. on July 3, 2017, the loaded
fireworks barge will transit from Pier 50 to the launch site in
Richmond Marina in approximate position 37[deg]54'40'' N.,
122[deg]21'05'' W. (NAD 83) where it will remain until the conclusion
of the fireworks display. Upon the commencement of the 20-minute
fireworks display, scheduled to begin at 9:30 p.m. on July 3, 2017, the
safety zone will increase in size and encompass the navigable waters
around and under the fireworks barge within a radius 560 feet in
Richmond Marina in approximate position 37[deg]54'40'' N.,
122[deg]21'05'' W. (NAD 83) for the Fourth of July Fireworks, City of
Richmond in 33 CFR 165.1191, Table 1, Item number 9. This safety zone
will be in effect from 8 a.m. on July 1, 2017 until 10 p.m. on July 3,
2017.
    Under the provisions of 33 CFR 165.1191, unauthorized persons or
vessels are prohibited from entering into, transiting through, or
anchoring in the safety zone during all applicable effective dates and
times, unless authorized to do so by the PATCOM. Additionally, each
person who receives notice of a lawful order or direction issued by an
official patrol vessel shall obey the order or direction. The PATCOM is
empowered to forbid entry into and control the regulated area. The
PATCOM shall be designated by the Commander, Coast Guard Sector San
Francisco. The PATCOM may, upon request, allow the transit of
commercial vessels through regulated areas when it is safe to do so.
This notice is issued under authority of 33 CFR 165.1191 and 5 U.S.C.
552(a). In addition to this notice in the Federal Register, the Coast
Guard will provide the maritime community with extensive advance
notification of the safety zone and its enforcement period via the
Local Notice to Mariners.
    If the Captain of the Port determines that the regulated area need
not be enforced for the full duration stated in this notice, a
Broadcast Notice to Mariners may be used to grant general permission to
enter the regulated area.

    Dated: May 4, 2017.
Anthony J. Ceraolo,
Captain, U.S. Coast Guard, Captain of the Port, San Francisco.
[FR Doc. 2017-13841 Filed 6-29-17; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 139 (Tuesday, July 21, 2015)]
[Notices]
[Pages 43095-43096]
[FR Doc No: 2015-17795]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0411]

Cooperative Agreement for Research, Education, and Outreach in
Support of the Food and Drug Administration Food Safety Modernization
Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for a cooperative agreement to support the
FDA Food Safety Modernization Act (FSMA) implementation efforts by the
Illinois Institute of Technology's (IIT) National Center for Food
Safety and Technology (NCFST). The estimated amount of support in
fiscal year (FY) 2015 will be for up to $5 million (direct plus
indirect costs), with the possibility of 2 additional years of support
for up to $7 million each year, subject to the availability of funds.
This award will improve public health by continued support of an
applied research, education, and outreach program related to the
science behind and implementation of preventive controls, and on
training and technical assistance.

DATES: Important dates are as follows:
    1. The application due date is August 14, 2015.
    2. The anticipated start date is September 1, 2015.
    3. The opening date is August 1, 2015.
    4. The expiration date is August 31, 2015.

ADDRESSES: Submit the electronic application to: http://www.grants.gov.
For more information, see section III of the SUPPLEMENTARY INFORMATION
section of this notice.

FOR FURTHER INFORMATION CONTACT: Wanda Honeyblue, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (CFSAN),
5100 Paint Branch Pkwy. (HFS-002), Rm. 4D-034, College Park, MD 20740,
301-796-3500, email<EMAIL_ADDRESS>or Martin Bernard,
Division of State Acquisitions, Agreements and Grants (DSAAG) (HFA-
500), Food and Drug Administration, 5630 Fishers Lane, Rockville, MD
20857,<PHONE_NUMBER>, email<EMAIL_ADDRESS>    For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at http://www.grants.gov/.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

    Funding Opportunity Number: RFA-FD-15-035
    Catalog of Federal Domestic Assistance Number: 93.103

A. Background

    FDA has supported the NCFST under seven previously awarded
cooperative agreements (53 FR 15736, 56 FR 46189, 59 FR 24703, 64 FR
39512, 69 FR 25405, 74 FR 26408, and 79 FR 23360). NCFST was
established by IIT to bring together the food safety and technology
expertise of academia, industry, and FDA for the purpose of supporting
research and outreach efforts related to the safety of foods based on a
common goal of enhancing the safety of the food supply for U.S.
consumers. NCFST has been successful in developing research programs
such as those related to low-moisture foods, and outreach programs such
as those related to sprout safety; these successes were achieved as a
result of NCFST partnering with industry, academia, and FDA.
    NCFST is structured so that representatives of participating
organizations play a role in establishing policy and administrative
procedures, as well as identifying long- and short-term research,
outreach, and training needs. With this organizational structure, NCFST
is able to build cooperative food safety programs on a foundation of
knowledge about current industrial trends in food processing and
packaging technologies, regulatory perspectives from public health
organizations, and fundamental scientific expertise from academia. This
award will improve public health by continued support of an applied
research, education, and outreach program related to the science behind
and implementation of preventive controls associated with
manufacturing, processing, packing, and holding of human and animal
food, and on training and technical assistance.

B. Program Objectives

    With an increasingly diverse domestic and global food supply, FDA
continues to face complex food safety issues associated with the foods
that it regulates. Some of these complex issues can be effectively
addressed by further strengthening the available science-based programs
established through NCFST/Institute for Food Safety and Health (IFSH).
FDA also believes that innovative research and outreach programs such
as those established at NCFST/IFSH can further support the development
of proactive approaches to

the prevention of food safety problems before they occur. With the
enactment of FSMA in 2011, the collaboration with NCFST/IFSH has become
increasingly important as FDA works to fulfill its mandate to develop a
modern, prevention-based food safety system. FDA regards the
development and strengthening of public-private partnerships for
research and outreach on preventive controls to be a key element of its
FSMA implementation strategy.
    This cooperative agreement will provide continued support so that
NCFST/IFSH can meet the objective to support the implementation of FSMA
through research, education, and outreach, with particular emphasis on
identifying the science to support implementation of preventive
controls associated with manufacturing, processing, packing, and
holding of human and animal food, and on training and technical
assistance.

C. Eligibility Information

    Competition is limited to IIT as FDA believes IIT's continued
support of the Food Safety Preventive Controls Alliance (FSPCA) already
established at NCFST/IFSH uniquely qualifies IIT to fulfill the
objectives of the proposed cooperative agreement. IIT's Moffett Center,
where NCFST is located, is a unique facility that includes offices,
classrooms, a distance-learning center, and support facilities, which
permit appropriate research, development, and training activities. The
physical layout of the facility provides maximum versatility in the use
and capability to simultaneously operate several different activities
related to research, development, and training to support FSMA rules.
The distance learning facility located in room 216 in building 91 of
the IIT Moffett Campus is equipped with state-of-the-art audio-visual
equipment for conducting and broadcasting interactive training programs
and workshops to the food industry, as well as for Webinar
communications with IFSH stakeholders, including government, academia,
and industry.
    Since 1988, IIT has provided an environment in which scientists
from diverse backgrounds such as academia, government, and industry
have brought their unique perspectives to focus on contemporary issues
of food safety. NCFST/IFSH functions as a neutral ground where
scientific exchange about generic food safety issues occurs freely and
is channeled into the design of cooperative food safety programs.
Activities at NCFST are focused on multiple areas associated with food
safety and FSMA, including but not limited to, preventive controls for
human and animal foods, supplier verification, and national training.
    Since 2011, IIT has served as the coordinator of the FSPCA and,
since 2012, the Sprout Safety Alliance (SSA), leveraging the expertise
of academia, industry, and FDA for the purpose of developing and
delivering standardized curricula related to food safety and FSMA
requirements. In addition to alliance training, NCFST/IFSH plans to
develop the National Training and Technical Assistance Network to
provide outreach and technical assistance to industry in the future.
The new distance-learning training center developed at the IIT's
Moffett Center can be used to partially address training and outreach
needs related to FSMA. Through this facility, training can be provided
on curricula currently being developed by the FSPCA for human and
animal food and by the SSA for sprouts, and for training activities
related to other appropriate FSMA activities such as the Foreign
Supplier Verification Program.
    The proposed cooperative activities will fill existing gaps in
knowledge, food safety training, and expertise for outreach associated
with improving the safety of foods via FSMA implementation, and will
provide fundamental food safety information in the public domain for
use by all segments of the food science community for industry and
regulatory training activities.

II. Award Information/Funds Available

A. Award Amount

    The Center for Food Safety and Applied Nutrition (CFSAN) at FDA
intends to commit up to $5 million in FY 2015 (direct plus indirect
costs) with the possibility of 2 additional years of up to $ 7 million
each year. Future year amounts will depend on annual appropriations and
successful performance.

B. Length of Support

    The award will provide 1 year of support and include future
recommended support for 2 additional years, contingent upon
satisfactory performance in the achievement of project and program
objectives during the preceding year and the availability of Federal
fiscal year appropriations.

III. Electronic Application, Registration, and Submission

    Only one electronic application will be accepted. To submit an
electronic application in response to this FOA, the applicant should
first review the full announcement located at http://www.grants.gov/.
(FDA has verified the Web site addresses throughout this document, but
FDA is not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register.) For the
electronically submitted application, the following steps are required:
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number
     Step 2: Register With System for Award Management (SAM)
     Step 3: Obtain Username & Password
     Step 4: Authorized Organization Representative (AOR)
Authorization
     Step 5: Track AOR Status
     Step 6: Register With Electronic Research Administration
(eRA) Commons
    Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed
these steps, submit the electronic application to: http://www.grants.gov.

    Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17795 Filed 7-20-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 93 (Thursday, May 14, 2015)]
[Proposed Rules]
[Pages 27621-27623]
[FR Doc No: 2015-11669]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 745

[EPA-HQ-OPPT-2005-0049; FRL-9927-40]

Lead; Renovation, Repair and Painting Program; Lead Test Kit
Stakeholder Meeting; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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SUMMARY: On April 22, 2008, EPA published the Lead Renovation, Repair
and Painting (RRP) rule, which established performance recognition
criteria for lead test kits for use as an option to determine if
regulated lead-based paint is not present in target housing and child-
occupied facilities. The use of an EPA-recognized lead test kit, when
used by a trained professional, can reliably determine that regulated
lead-based paint is not present by virtue of a negative result. The RRP
rule also established negative-response and positive-response criteria
outlined in the CFR for lead test kits recognized by EPA. This document
announces EPA's plan to hold a meeting for interested stakeholders and
the public on Thursday, June 4, 2015. At the meeting, EPA is seeking
information related to: The existing market for lead test kits as
referenced in the 2008 RRP rule; the development or modification of
lead test kit(s) that may meet EPA's positive-response criterion (in
addition to the negative-response criterion); and other alternatives
for lead-based paint field testing.

DATES: The meeting will be held on Thursday, June 4, 2015 from 10 a.m.
to 12 p.m.
    Requests to attend the meeting should be sent to the Agency's lead
information Contact Us form at http://www2.epa.gov/lead/forms/contact-us or the technical information points of contact under FOR FURTHER
INFORMATION CONTACT. Upon request, Web and telephone conferencing
information will be provided for those who wish to attend the meeting
remotely. RSVP responses confirming attendance to the meeting either in
person or remotely should be sent to the Agency's lead information
Contact Us form at http://www2.epa.gov/lead/forms/contact-us or the
technical persons listed under FOR FURTHER INFORMATION CONTACT on or
before May 26, 2015. Requests to share information on the related
topics at the meeting should be sent to the Agency's lead information
Contact Us form at http://www2.epa.gov/lead/forms/contact-us or the
technical persons listed under FOR FURTHER INFORMATION CONTACT on or
before May 26, 2015. Additionally, registered participants who wish to
provide responses to the requested lead test kit topics during the
meeting should notify the Agency via EPA's lead information Contact Us
form at http://www2.epa.gov/lead/forms/contact-us or the technical
persons listed under FOR FURTHER INFORMATION CONTACT on or before May
26, 2015.
    To request accommodation of a disability, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT,
preferably by May 26, 2015, to give EPA as much time as possible to
process your request.

ADDRESSES: The meeting will be held at EPA William Jefferson Clinton
East Building, 1201 Constitution Ave. NW., Washington, DC 20004.
    Meeting participants and other interested parties who wish to
respond in writing to the requested lead test kit topics outlined
above, as well as the forthcoming Information Docket, may submit
written materials identified by docket identification (ID) number EPA-
HQ-OPPT-2005-0049, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, are available at http://www.epa.gov/dockets. The docket for this action will remain open until
July 6, 2015.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Christina Wadlington, National Program Chemicals Division (7404M),
Office of Pollution Prevention and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>or
Toiya Goodlow, National Program Chemicals Division (7404M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202)
566-2305; email address<EMAIL_ADDRESS>    For general information contact: The National Lead Information
Center, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620;
telephone number: 1-800-424 -LEAD (5323); online information request
form: http://www2.epa.gov/lead/forms/lead-hotline-national-lead-information-center.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This document is directed to stakeholders that develop, manufacture
and/or sell lead test kits or other lead-based paint field testing
instruments. You may be potentially affected by this action if you
manufacture or sell lead test kits, or if you use lead test kits to
determine if lead-safe work practices are required under the RRP rule
to perform renovations for compensation in target housing or child-
occupied facilities. Examples of child-occupied facilities are day-care
centers, preschools, and kindergarten classrooms.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket ID number EPA-HQ-
OPPT-2005-0049, is available at http://www.regulations.gov or at the
Office of Pollution Prevention and Toxics Docket (OPPT Docket),
Environmental Protection Agency Docket Center (EPA/DC), EPA William
Jefferson Clinton West Building, Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC 20004. The Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OPPT Docket is<PHONE_NUMBER>. Please review
the visitor instructions and additional information about the docket
available at http://www.epa.gov/dockets. EPA will provide further
information regarding topics to be discussed at the meeting in an
Information Document to registered participants. That information also
will be posted on www2.epa.gov/lead and placed in the docket for this
action.

C. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI

must be submitted for inclusion in the public docket. Information so
marked will not be disclosed except in accordance with procedures set
forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify this document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. Follow the detailed instructions as provided
under ADDRESSES. Respond to specific questions posed by the Agency.
    iii. Explain why you agree or disagree; suggest alternatives.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced by the Agency and others.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified in this document.

II. Background

    In the Federal Register of April 22, 2008 (73 FR 21692) (FRL-8355-
7), EPA published the Lead-Based Paint Renovation, Repair and Painting
rule, which requires contractors to use lead-safe work practices during
renovation, repair, and painting activities that disturb lead-based
paint in target housing and child-occupied facilities built before 1978
unless a determination can be made that no lead-based paint would be
disturbed during the renovation or repair. The use of an EPA-recognized
lead test kit, when used by a trained professional, can reliably
determine that regulated lead-based paint is not present by virtue of a
negative result. The federal standards for lead-based paint in target
housing and child-occupied facilities is a lead content in paint that
equals or exceeds a level of 1.0 milligram per square centimeter (mg/
cm\2\) or 0.5 percent by weight. If regulated lead-based paint is not
present, there is no requirement to employ lead-safe work practices
under the RRP rule.
    The RRP rule established negative-response and positive-response
criteria outlined in 40 CFR 745.88(c) for lead test kits recognized by
EPA. Lead test kits recognized before September 1, 2010 must meet only
the negative-response criterion outlined in 40 CFR 745.88(c)(1). The
negative-response criterion states that for paint containing lead at or
above the regulated level, 1.0 mg/cm\2\ or 0.5 percent by weight, a
demonstrated probability (with 95% confidence) of a negative response
less than or equal to 5 percent of the time must be met. The
recognition of kits that meet only this criterion will last until EPA
publicizes its recognition of the first test kit that meets both of the
criteria outlined in the rule.
    Lead test kits recognized after September 1, 2010 must meet both
the negative-response and positive-response criteria outlined in 40 CFR
745.88(c)(1)-(2). The positive-response criterion states that for paint
containing lead below the regulated level, 1.0 mg/cm\2\ or 0.5% by
weight, a demonstrated probability (with 95% confidence) of a positive
response less than or equal to 10% of the time must be met.
Qualitatively speaking, lead test kits recognized by EPA should also
serve as a quick, inexpensive, reliable, and easy to perform option for
lead-based paint testing in the field.
    Despite the EPA's commitment of resources to this effort, to date
no test kit has met both of the performance criteria outlined in the
RRP rule. However, there are two EPA-recognized test kits commercially
available nationwide that meet the false-negative criterion and
continue to be recognized by EPA. Therefore, in an effort to understand
the current state of the science for lead test kits and lead-based
paint field testing alternatives, as well as the existing market and
potential availability of additional test kits, EPA is soliciting input
from relevant stakeholders. EPA is convening a meeting and webinar for
interested stakeholders and the public on Thursday, June 4, 2015 to
seek information related to: (1) The existing market for lead test kits
as referenced in the 2008 RRP rule; (2) the development or modification
of lead test kit(s) that may meet EPA's positive-response criterion (in
addition to the negative-response criterion); and (3) other
alternatives for lead-based paint field testing. EPA will provide
further information regarding topics to be discussed at the meeting in
an Information Document to be posted on www2.epa.gov/lead and placed in
the docket for this action. Meeting participants and other interested
parties who wish to respond in writing to the requested lead test kit
topics outlined above, as well as the forthcoming Information Docket,
may submit written materials to the docket until July 6, 2015.

III. References

    As indicated under ADDRESSES, a docket has been established for
this rulemaking under docket ID number EPA-HQ-OPPT-2005-0049. The
docket includes this document and other information.

EPA. Lead; Renovation, Repair, and Painting Program; Final Rule.
Federal Register, April 22, 2008 (73 FR 21692) (FRL-8355-7).

    Authority: 15 U.S.C. 2601 et seq.

    Dated: May 8, 2015.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2015-11669 Filed 5-13-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 23 (Friday, February 5, 2021)]
[Notices]
[Pages 8376-8379]
[FR Doc No: 2021-02429]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2021-0002]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: New or modified Base (1-percent annual chance) Flood
Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA)
boundaries or zone designations, and/or regulatory floodways
(hereinafter referred to as flood hazard determinations) as shown on
the indicated Letter of Map Revision (LOMR) for each of the communities
listed in the table below are finalized. Each LOMR revises the Flood
Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance
Study (FIS) reports,

currently in effect for the listed communities. The flood hazard
determinations modified by each LOMR will be used to calculate flood
insurance premium rates for new buildings and their contents.

DATES: Each LOMR was finalized as in the table below.

ADDRESSES: Each LOMR is available for inspection at both the respective
Community Map Repository address listed in the table below and online
through the FEMA Map Service Center at https://msc.fema.gov.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final flood hazard determinations as shown in the
LOMRs for each community listed in the table below. Notice of these
modified flood hazard determinations has been published in newspapers
of local circulation and 90 days have elapsed since that publication.
The Deputy Associate Administrator for Insurance and Mitigation has
resolved any appeals resulting from this notification.
    The modified flood hazard determinations are made pursuant to
section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4105, and are in accordance with the National Flood Insurance Act of
1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The new or modified flood hazard information is the basis for the
floodplain management measures that the community is required either to
adopt or to show evidence of being already in effect in order to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    This new or modified flood hazard information, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities.
    This new or modified flood hazard determinations are used to meet
the floodplain management requirements of the NFIP and are used to
calculate the appropriate flood insurance premium rates for new
buildings, and for the contents in those buildings. The changes in
flood hazard determinations are in accordance with 44 CFR 65.4.
    Interested lessees and owners of real property are encouraged to
review the final flood hazard information available at the address
cited below for each community or online through the FEMA Map Service
Center at https://msc.fema.gov.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                      Location and case        Chief executive officer of                                                                     Community
  State and county           No.                        community                 Community map repository         Date of modification          No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama: Tuscaloosa  City of Tuscaloosa   The Honorable Walt Maddox, Mayor,     City Hall, 2201 University    Jan. 4, 2021.................       010203
 (FEMA Docket No: B-  (20-04-2661P).       City of Tuscaloosa, P.O. Box 2089,    Boulevard, Tuscaloosa, AL
 2076).                                    Tuscaloosa, AL 35403.                 35401
Colorado:
    Boulder (FEMA    City of Boulder (20- The Honorable Sam Weaver, Mayor,      Central Records Department,   Jan. 7, 2021.................       080024
     Docket No.: B-   08-0376P).           City of Boulder, P.O. Box 791,        1777 Broadway, Boulder, CO
     2064).                                Boulder, CO 80306.                    80306.
    Boulder (FEMA    Town of Jamestown    The Honorable Tara Schoedinger,       Town Hall, 118 Main Street,   Jan. 11, 2021................       080216
     Docket No.: B-   (20-08-0179P).       Mayor, Town of Jamestown, P.O. Box    Jamestown, CO 80455.
     2064).                                298, Jamestown, CO 80455.
Connecticut: New     Town of Branford     The Honorable James B. Cosgrove,      Engineering Department, 1019  Jan. 15, 2021................       090073
 Haven (FEMA Docket   (20-01-0799P).       First Selectman, Town of Branford     Main Street, Branford, CT
 No.: B-2067).                             Board of Selectmen, 1019 Main         06405.
                                           Street, Branford, CT 06405.
Florida:
    Lake (FEMA       City of Leesburg     Mr. Al Minner, Manager, City of       Planning and Zoning           Jan. 13, 2021................       120136
     Docket No.: B-   (20-04-0931P).       Leesburg, 501 West Meadow Street,     Department, 204 North 5th
     2067).                                Leesburg, FL 34748.                   Street, Leesburg, FL 34748.
    Lake (FEMA       Unincorporated       The Honorable Leslie Campione,        Lake County Public Works      Jan. 13, 2021................       120421
     Docket No.: B-   areas of Lake        Chair, Lake County Board of           Department, 323 North
     2067).           County (20-04-       Commissioners, 315 West Main          Sinclair Avenue, Tavares,
                      0931P).              Street, Tavares, FL 32778.            FL 32778.
    Monroe (FEMA     Unincorporated       The Honorable Heather Carruthers,     Monroe County Building        Jan. 4, 2021.................       125129
     Docket No.: B-   areas of Monroe      Mayor, Monroe County Board of         Department, 2798 Overseas
     2064).           County (20-04-       Commissioners, 500 Whitehead          Highway, Suite 300,
                      3334P).              Street, Suite 102, Key West, FL       Marathon, FL 33050.
                                           33040.
Georgia:

    Mitchell (FEMA   Unincorporated       The Honorable Benjamin Hayward,       Mitchell County Building and  Jan. 7, 2021.................       130438
     Docket No.: B-   areas of Mitchell    Chairman, Mitchell County Board of    Zoning Department, 26 North
     2064).           County (20-04-       Commissioners, 26 North Court         Court Street, Camilla, GA
                      3145P).              Street, Camilla, GA 31730.            31730.
    Oconee (FEMA     City of              The Honorable Bob Smith, Mayor, City  City Hall, 191 VFW Drive,     Jan. 8, 2021.................       130369
     Docket No.: B-   Watkinsville, (19-   of Watkinsville, 191 VFW Drive,       Watkinsville, GA 30677.
     2064).           04-6350P).           Watkinsville, GA 30677.
North Carolina:      Unincorporated       The Honorable Frank Williams,         Brunswick County Department   Jan. 4, 2021.................       370295
 Brunswick (FEMA      areas of Brunswick   Chairman, Brunswick County Board of   of Floodplain Management
 Docket No.: B-       County (20-04-       Commissioners, P.O. Box 249,          Department, 75 Courthouse
 2064).               4291P).              Bolivia, NC 28422.                    Drive, Building 1, Bolivia,
                                                                                NC 28422.
Oregon: Washington   Unincorporated       The Honorable Kathryn Harrington,     Washington County Land Use    Jan. 4, 2021.................       410238
 (FEMA Docket No.:    areas of             Chair, Washington County Board of     and Transportation
 B-2059).             Washington County,   Commissioners, 155 North 1st          Department, 1400 Southwest
                      (19-10-1199P).       Avenue, Suite 300, Hillsboro, OR      Walnut Street, Hillsboro,
                                           97124.                                OR 97123.
Texas:
    Collin and       City of Sachse (20-  Ms. Gina Nash, Manager, City of       Engineering Department, 3815  Jan. 8, 2021.................       480186
     Dallas (FEMA     06-1068P).           Sachse, 3815 Sachse Road, Building    Sachse Road, Building B,
     Docket No.: B-                        B, Sachse, TX 75048.                  Sachse, TX 75048.
     2064).
    Ellis (FEMA      City of Midlothian   The Honorable Richard Reno, Mayor,    City Hall, 104 West Avenue    Jan. 15, 2021................       480801
     Docket No.: B-   (20-06-1890P).       City of Midlothian, 104 West Avenue   E, Midlothian, TX 76065.
     2064).                                E, Midlothian, TX 76065.
    Ellis (FEMA      Unincorporated       The Honorable Todd Little, Ellis      Ellis County Engineering      Jan. 4, 2021.................       480798
     Docket No.: B-   areas of Ellis       County Judge, 101 West Main Street,   Department, 109 South
     2064).           County (20-06-       Waxahachie, TX 75165.                 Jackson Street, Waxahachie,
                      1084P).                                                    TX 75165.
    Guadalupe (FEMA  City of Cibolo (20-  Mr. Robert T. Herrera, Manager, City  Geographic Information        Jan. 7, 2021.................       480267
     Docket No.: B-   06-0736P).           of Cibolo, 200 South Main Street,     Systems (GIS) Department,
     2064).                                Cibolo, TX 78108.                     200 South Main Street,
                                                                                Cibolo, TX 78108.
    Guadalupe (FEMA  City of Schertz (20- Mr. Mark Browne, Manager, City of     Geographic Information        Jan. 7, 2021.................       480269
     Docket No.: B-   06-0736P).           Schertz, 1400 Schertz Parkway,        Systems (GIS) Department,
     2064).                                Schertz, TX 78154.                    10 Commercial Place,
                                                                                Schertz, TX 78154.
    Johnson (FEMA    City of Venus (20-   The Honorable James L Burgess,        Public Works and Water/Sewer  Jan. 4, 2021.................       480883
     Docket No.: B-   06-1084P).           Mayor, City of Venus, 700 West        Department, 700 West
     2064).                                Highway 67, Venus, TX 76084.          Highway 67, Venus, TX
                                                                                76084.
Utah: Davis (FEMA    City of Clearfield   Mr. J.J. Allen, Manager, City of      City Hall, 55 South State     Jan. 4, 2021.................       490041
 Docket No.: B-       (20[dash]08[dash]0   Clearfield, 55 South State Street,    Street, Clearfield, UT
 2064).               267P).               Clearfield, UT 84015.                 84015.
Virginia: Loudoun    Unincorporated       Mr. Tim Hemstreet, Loudoun County     Loudoun County Mapping and    Dec. 28, 2020................       510090
 (FEMA Docket No.:    areas of Loudoun     Administrator, P.O. Box 7000,         Geographic Information
 B-2064).             County (20-03-       Leesburg, VA 20177.                   Department, 1 Harrison
                      0748P).                                                    Street Southeast, Leesburg,
                                                                                VA 20175.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2021-02429 Filed 2-4-21; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 85, Number 225 (Friday, November 20, 2020)]
[Notices]
[Pages 74488-74489]
[FR Doc No: 2020-25681]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2020-0087]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
provides the public notice that on November 5, 2020, Illinois Central
Railroad Company, for itself and on behalf of the U.S. railroad
subsidiaries operating under the Canadian National Railway Company
(CN), petitioned the Federal Railroad Administration (FRA) for a waiver
of compliance from certain provisions of the Federal railroad safety
regulations contained at 49 CFR part 232, Brake System Safety Standards
for Freight and Other Non-Passenger Trains and Equipment; End-of-Train
Devices. FRA assigned the petition Docket Number FRA-2020-0087.
    Specifically, CN proposes to use software technology to implement a
virtual three-dimensional simulation as an alternative to satisfy the
``hands-on'' portion of periodic refresher training required by 49 CFR
232.203(b)(8). Refresher training is required at intervals not to
exceed 3 years, and must consist of classroom and hands-on training, as
well as testing. CN states the training will better equip CN employees
to perform Class I freight air brake tests and there will be no impact
on safety.
    The instructor-led simulation is based on performance of a Class I
freight air brake test and is designed to place the user in a virtual
realistic scenario. The user is required to perform a variety of
inspection tasks relating to preprogrammed defects including, but not
limited to, closed cut-out cocks, uncoupled air hoses, closed angle
cocks, improperly positioned retainer valves, fouled brake rigging, and
using a two-way end-of-train device. CN states that it is often
difficult to stage various types of freight air brake equipment with
defects to demonstrate the location of key components. CN also states
that the simulation allows CN to control the environment and employees
are better able to examine components of the air brake system.
Furthermore, given the restrictions of person-to-person contact related
to COVID-19, safety is further enhanced by utilizing the simulation. CN
proposes to apply this waiver system-wide to all CN personnel
responsible for performing Class I freight air brakes tests. CN
explains it may use the simulation as a supplement at initial training,
but it will not replace traditional hands-on training employees receive
at initial training.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation (DOT), 1200 New Jersey Ave. SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Ave. SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m.,

Monday through Friday, except Federal Holidays.
    Communications received by January 4, 2021 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. 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 https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2020-25681 Filed 11-19-20; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 87, Number 205 (Tuesday, October 25, 2022)]
[Rules and Regulations]
[Pages 64380-64382]
[FR Doc No: 2022-23084]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0626]
RIN 1625-AA00

Safety Zone; Firework Event, Willamette River, Portland, OR

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
certain waters of the Willamette River. This action is necessary to
provide for the safety of life on these navigable waters near Oaks
Park, Portland, OR, during a fireworks display on October 31, 2022.
This regulation prohibits persons and vessels from being in the safety
zone unless authorized by the Captain of the Port Sector Columbia River
or a designated representative.

DATES: This rule is effective from 6:30 to 8 p.m. on October 31, 2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0626 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 Carlie Gilligan, Waterways Management Division, Marine
Safety Unit Portland, 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

    On June 14, 2022, the Oaks Park Association notified the Coast
Guard that it will be conducting a fireworks display from 7 to 7:30
p.m. on October 31, 2022. The fireworks are to be launched from a barge
in the Willamette River offshore of Oaks Park, Portland, Oregon.
Hazards from firework displays include accidental discharge of
fireworks, dangerous projectiles, and falling hot embers or other
debris.
    In response, on August 11, 2022, the Coast Guard published a notice
of proposed rulemaking (NPRM) titled Safety Zone; Firework Event,
Willamette River, Portland, OR (87 FR 49568). There we stated why we
issued the NPRM, and invited comments on our proposed regulatory action
related to this fireworks display. During the comment period that ended
September 12, 2022, we received no comments.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Columbia River
(COTP) has determined that potential hazards associated with the
fireworks to be used in this October 31, 2022 display will be a safety
concern for anyone within a 1,000 ft. radius of the barge. The purpose
of this rule is to ensure safety of vessels and the navigable waters in
the safety zone before, during, and after the scheduled event.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received no comments on our NPRM published
August 11, 2022. There are no changes in the regulatory text of this
rule from the proposed rule in the NPRM.
    The COTP is establishing a safety zone from 6:30 to 8 p.m. on
October 31, 2022. The safety zone covers navigable waters within a
1,000 ft radius of a barge in the Willamette River located offshore of
Oaks Park, Portland, OR. The duration of the zone is intended to ensure
the safety of vessels and these navigable waters before, during, and
after the scheduled 7 to 7:30 p.m. fireworks display. No vessel or
person will be permitted to enter the safety zone 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. 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, and duration of the safety zone. The safety zone created by
this rule is designed to minimize its impact on navigable waters. This
rule will prohibit entry into certain navigable waters of the
Willamette River and is not anticipated to exceed two hours in
duration. Thus, restrictions on vessel movement within that particular
area are expected to be minimal. Moreover, under certain conditions,
vessels may still transit through the safety zone when permitted by the
COTP. The Coast Guard will issue a Broadcast Notice to Mariners via
VHF-FM marine channel 16 about the zone and the rule allows vessels to
seek permission to enter 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 received no comments from the Small Business
Administration on this rulemaking. 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 affects 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 does 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 a
safety zone lasting 1.5 hours that will prohibit entry within 1,000 ft.
of a fireworks barge in the Willamette River in the vicinity of Oaks
Park, Portland, OR. It is categorically excluded from further review
under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual
023-01-001-01, Rev. 1. A Record of Environmental Consideration
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 165

    Harbors, Marine Safety, Navigation (water), Reporting and
recordkeeping requirements, Security Measures, Waterways.

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T13-0626 to read as follows:

Sec.  165.T13-0626  Safety Zone; Willamette River, Portland, OR.

    (a) Location. The following area is a safety zone: All navigable
waters of the Willamette River, from surface to bottom, in a 1,000 ft.
radius from the fireworks barge off shore of Oaks Park, Portland, OR.
    (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 Columbia River (COTP) in the enforcement of the
regulations in this section.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by calling<PHONE_NUMBER> or the Sector Columbia River
Command Center on Channel 16 VHF-FM. Those in the safety zone must
comply with all lawful orders or directions given to them by the COTP
or the designated representative.
    (d) Enforcement period. This section will be enforced from 6:30 to
8 p.m. on October 31, 2022. It will be subject to enforcement this
entire period unless the COTP determines it is no longer needed, in
which case the Coast Guard will inform mariners via Notice to Mariners.

    Dated: September 19, 2022.
M. Scott Jackson,
Captain, U.S. Coast Guard, Captain of the Port Sector Columbia River.
[FR Doc. 2022-23084 Filed 10-24-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 220 (Thursday, November 18, 2021)]
[Notices]
[Pages 64462-64463]
[FR Doc No: 2021-25176]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-385-000]

Innovative Owner 43, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Innovative Owner 43, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice

and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is December 2, 2021.
    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 may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TTY,<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2021-25176 Filed 11-17-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 35 (Friday, February 21, 2014)]
[Notices]
[Pages 9908-9909]
[FR Doc No: 2014-03677]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0720]

International Conference on Harmonisation; E2B(R3) Electronic
Transmission of Individual Case Safety Reports; Data Elements and
Message Specification; Appendix on Backwards and Forwards
Compatibility; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``E2B(R3) Electronic
Transmission of Individual Case Safety Reports (ICSRs): Implementation
Guide--Data Elements and Message Specification'' (the E2B(R3)
implementation guidance) and an appendix to the guidance entitled
``ICSRs: Appendix to the Implementation Guide--Backwards and Forwards
Compatibility'' (the BFC appendix). The guidance was prepared under the
auspices of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The E2B(R3) implementation guidance is intended to revise the standards
for submission of ICSRs and improve the inherent quality of the data,
enabling improved handling and analysis of ICSR reports. The BFC
appendix describes the relationship between data elements from the 2001
ICH E2B guidance and the E2B(R3) implementation guidance.

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

ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information (HFD-240), Center for Drug Evaluation
and Research (CDER), Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or the Office
of Communication, Outreach and Development (HFM-40), Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist the office in processing your
requests. The guidance may also be obtained by mail by calling CBER at
1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Roger Goetsch,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg 22, Rm. 4491, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>; or Lise Stevens, Center for Biologics Evaluation
and Research (HFM-17), Food and Drug Administration, 1401 Rockville
Pike, Suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>, Regarding the
ICH: Michelle Limoli, Center for Drug Evaluation and Research,
International Programs, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3342, Rockville, MD 20993-0002, 301-796-
8377.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA;
and the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the

preparation of documentation, is provided by the International
Federation of Pharmaceutical Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of October 20, 2011 (76 FR 65199), FDA
published a notice announcing the availability of a draft guidance
entitled ``E2B(R3) Electronic Transmission of Individual Case Safety
Reports (ICSRs): Implementation Guide--Data Elements and Message
Specification'' and an appendix to the guidance entitled ``ICSRs:
Appendix to the Implementation Guide--Backwards and Forwards
Compatibility.'' FDA also published a correction notice (November 16,
2011, 76 FR 71044) giving interested persons an opportunity to submit
comments by January 18, 2012.
    After consideration of the comments received and revisions to the
guidance, a final draft of the guidance was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies in November 2012.
    The guidance provides guidance on the data elements, terminology,
and exchange standards for the submission of ICSRs to improve the
inherent quality of adverse event data and enable improved handling and
analysis of ICSRs. The E2B(R3) implementation guidance provides support
for the implementation of software tools for creating, editing,
sending, and receiving electronic ICSR messages. The E2B(R3)
implementation guidance also provides instruction for how
pharmaceutical industries and regulatory authorities should use the
``International Organization for Standardization (ISO) 27953-2 (Part
2)'' ICSR messaging standard for exchanging pharmacovigilance
information among ICH regions and in other countries adopting ICH
guidelines. The BFC appendix describes the relationship between data
elements from E2B(R2) and E2B(R3) and is intended to assist reporters
and recipients in implementing systems with special focus on the
recommendations for converting back and forth between E2B(R2) and
E2B(R3) ICSR reports. The E2B(R3) implementation guidance and BFC
appendix are being issued as a package that includes schema files and
additional technical information to be used for creating compliant ICSR
files.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

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

    Dated: February 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03677 Filed 2-20-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: December 31, 2007 (Volume 72, Number 249)]
[Notices]
[Page 74280-74281]
[DOCID:fr31de07-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[No. 946-007-Utah]

Hyrum City Hydroelectric Project; Notice of Availability of
Environmental Assessment

December 20, 2007.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office
of Energy Projects has reviewed the application for a subsequent
license for the Hyrum City Hydroelectric Project, and has prepared an
Environmental Assessment (EA). The operating project is located on
Blacksmith Fork River in Hyrum City, Cache County, Utah. The project
affects

about 17.03 acres of federal lands within the Wasatch Cache National
Forest.
    The EA contains the staff's analysis of the potential environmental
impacts of the project and concludes that licensing the project, with
appropriate environmental protective measures, would not constitute a
major federal action that would significantly affect the quality of the
human environment.
    A copy of the EA is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or for TTY,

(202) 502-8659.
    You may also register online at http://www.ferc.gov/esubscribenow.htm
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support at<EMAIL_ADDRESS>or toll-free
at 1-866-208-3676, or for TTY,<PHONE_NUMBER>.
    Please contact Gaylord Hoisington by telephone at<PHONE_NUMBER> or
by e-mail at<EMAIL_ADDRESS>if you have any questions.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-25324 Filed 12-28-07; 8:45 am]

BILLING CODE 6717-01-P