[Federal Register Volume 79, Number 29 (Wednesday, February 12, 2014)]
[Notices]
[Page 8462]
[FR Doc No: 2014-03015]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Synergizing Efforts in Standards Development for Cellular
Therapies and Regenerative Medicine Products; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA), Center for Biologics
Evaluation and Research (CBER), is announcing a public workshop
entitled ``Synergizing Efforts in Standards Development for Cellular
Therapies and Regenerative Medicine Products.'' The purpose of the
public workshop is to bring together a broad range of stakeholders to
discuss current and future standards development activities involving
cellular therapies and regenerative medicine products. This public
workshop is being rescheduled due to the government shutdown.
    Date and Time: The public workshop will be held on March 31, 2014,
from 8:30 a.m. to 4:30 p.m.
    Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm. 1503 A), Silver Spring, MD 20993-0002. Entrance for the
public workshop participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. Please visit
the following Web site for location, parking, security, and travel
information: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: Sherri Revell, Center for Biologics Evaluation and
Research (HFM-49), Food and Drug Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
email<EMAIL_ADDRESS>(Subject line: SESDCTRMP Workshop).
    Registration: Mail or fax your registration information (including
name, title, firm name, address, telephone, and fax numbers) to Sherri
Revell (see Contact Person) or email to<EMAIL_ADDRESS>(Subject line: SESDCTRMP Workshop Registration) by March 24, 2014.
There is no registration fee for the public workshop. Early
registration is recommended because seating is limited. Registration on
the day of the public workshop will be provided on a space available
basis beginning at 7:30 a.m.
    Streaming Webcast of the Public Workshop: For those unable to
attend in person, FDA will Webcast the public workshop. To join the
Webcast of the public workshop, please go to: https://collaboration.fda.gov/sesdctrmpworkshop/. If you have never attended an
Adobe Connect meeting before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. Get a
quick overview: http://www.adobe.com/go/connectpro_overview.
Registration is not required for those attending via Adobe Connect.
    If you need special accommodations due to a disability, please
contact Sherri Revell (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: Standardization efforts concerning the
clinical development of cellular therapies and regenerative medicine
products have generated a great deal of interest. These efforts include
standards development, expert opinion position papers, and professional
practice guidelines. However, relatively little is done to coordinate
the various existing efforts. In the public workshop, FDA hopes to
bring together a broad range of stakeholders of cellular therapies and
regenerative medicine products in order to:
     Inform stakeholders about the types of standards and
standards organizations that are available currently, the role that the
Federal Agencies play in standards development, and the potential role
that stakeholders can play in standards development.
     Provide a high-level overview of current standards
development activities in the fields of cellular therapy and
regenerative medicine and the regulatory application of standards.
     Provide opportunity for discussion of areas of high
interest for current or future standards development in the fields of
cellular therapy and regenerative medicine and to explore ways to
minimize redundancy and maximize collaboration.
    We encourage all who have an interest in the development of
cellular therapies and regenerative medicine products to attend the
public workshop.
    This public workshop is being rescheduled due to the government
shutdown. It was originally scheduled for October 7, 2013 (see 78 FR
43889, July 22, 2013). Those who registered for the original workshop
date must register again for the rescheduled date (see Registration).
    Transcripts: Please be advised that as soon as possible after a
transcript of the public workshop is available, it will be accessible
at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.
Transcripts of the public workshop may also be requested in writing
from the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: February 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03015 Filed 2-11-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Rules and Regulations]
[Pages 68343-68346]
[FR Doc No: 2019-27063]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0904]
RIN 1625-AA00

Safety Zone; Isabel Holmes Bridge, Wilmington, NC

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing two temporary safety zones on
the navigable waters of the Cape Fear River at the Isabel Holmes Bridge
in Wilmington, North Carolina. These temporary safety zones are
intended to restrict vessel traffic on the Cape Fear River from
December 15, 2019, through February 15, 2020, while work crews repair
the bridge and replace power cables crossing under the river. This rule
prohibits vessels or persons from being in the safety zones unless
specifically authorized by the Captain of the Port (COTP) North
Carolina or a designated representative.

DATES: This rule is effective without actual notice from December 16,
2019 through February 15, 2020. For the

purposes of enforcement, actual notice will be used from December 15,
2019, through December 16, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0904 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
contact Petty Officer Matthew Tyson, Waterways Management Division,
U.S. Coast Guard Sector North Carolina, Wilmington, NC; telephone:
(910) 772-2221, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NCDOT North Carolina Department of Transportation
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the North Carolina Department of
Transportation (NCDOT) did not notify the Coast Guard of the details of
the bridge maintenance project until November 28, 2019. Immediate
action is needed to protect persons and vessels from the hazards
associated with this project. It is impracticable and contrary to the
public interest to publish an NPRM because a final rule needs to be in
place by December 15, 2019, to protect against hazards to the work crew
and the public during the project.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to public interest
because immediate action is needed to protect persons and vessels from
the hazards associated with this bridge maintenance project, which
begins on December 15, 2019.

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 COTP North Carolina has
determined that potential hazards associated with the bridge
maintenance project, scheduled from December 15, 2019, through February
15, 2020, is a safety concern for workers and mariners on the Cape Fear
River at the Isabel Holmes Bridge in Wilmington, North Carolina. This
rule is necessary to protect safety of life from the potential hazards
associated with the project.

IV. Discussion of the Rule

    This rule establishes two safety zones on a portion of the Cape
Fear River from December 15, 2019, through February 15, 2020, to be
enforced while NCDOT conducts a bridge maintenance project. The project
will be in two parts: The repair of the Isabel Holmes Bridge, and
replacement of the power cables crossing under the river. The bridge
repair portion will impact, but not close, the navigable channel. The
cable replacement portion will require the navigable channel to be
closed. NCDOT will begin staging equipment around the bridge on
December 15, 2019.
    The first of the two safety zones will extend 100 feet from
equipment while it is within the navigable channel during the entire
maintenance period. The normal horizontal clearance of the channel
beneath the bridge is 200 feet. As a result, smaller vessels will be
able to transit under the bridge during this work phase. Maintenance
equipment will be able to be relocated outside of the navigable channel
for larger vessels during this stage of the project if at least a 48-
hour notice is given. This advance notice shall be given to the bridge
tender at<PHONE_NUMBER> or via VHF-FM marine channel 13 (165.65 MHz).
    The second safety zone will be enforced, within 300 feet of the
bridge, located at approximate position, 34[deg]15'06'' N,
077[deg]57'03'' W (NAD 1983) during the cable replacement portion of
the project. This cable replacement may last from 6 a.m. to 6 p.m. on
four separate days, finishing on February 15, 2020. The public will be
notified at least 48 hours in advance of each complete closure via
broadcast notice to mariners.
    The duration of these zones is intended to protect persons,
vessels, and the marine environment on the navigable waters of the Cape
Fear River during the bridge maintenance project. No vessel or person
will be permitted to enter either safety zone unless specifically
authorized by the Captain of the Port North Carolina or a designated
representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, and duration of the safety zones. The ability of vessels to
enter or transit a portion of the Cape Fear River near the Isabel
Holmes Bridge will be impacted while two safety zones are in place
during a bridge maintenance project lasting two months, from December
25, 2019, through February 15, 2020. The project will be in two parts:
The repair of the Isabel Holmes Bridge, and replacement of the power
cables crossing under the river. The bridge repair portion will impact,
but not close, the navigable channel. Smaller vessels will be able to
transit under the bridge during the repair work. Larger vessels will be
allowed to transit the channel during the repair work provided that
they provide a 48-hour notice requesting that equipment be relocated
from the channel. The Coast Guard will issue a Local Notice to Mariners
and transmit a Broadcast Notice to Mariners via VHF-FM marine channel
16 regarding the safety zone. The cable replacement portion will
require the navigable channel to be closed. Specific enforcement dates
and times for complete channel closures will be broadcast at least 48
hours in advance. However, this portion of the Cape Fear River is a low
traffic area during this time of the year.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
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 two
safety zones lasting two months. The first will prohibit entry within
100 feet of work equipment at the Isabel Holmes Bridge on the Cape Fear
River, and the second lasting 12 hours on four separate days that will
prohibit entry within 300 feet of the bridge while new power cables are
placed under the navigable channel. The rule is categorically excluded
from further review under paragraph L60a 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
where indicated under ADDRESSES.

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. 0170.1.

0
2. Add Sec.  165.T05-0904 to read as follows:

Sec.  165.T05-0904  Safety Zone; Isabel Holmes Bridge, Wilmington, NC.

    (a) Location. The following areas are safety zones:
    (1) Safety Zone 1. All navigable waters of the Cape Fear River
within 100 feet of work equipment at the Isabel Holmes Bridge in
Wilmington, NC;
    (2) Safety Zone 2. All navigable waters of the Cape Fear River
within a 300 foot radius of the Isabel Holmes Bridge in Wilmington, NC,
centered at approximate position 34[deg]15'06'' N, 077[deg]57'03'' W
(NAD 1983).
    (b) Definitions. As used in this section--
    Captain of the Port means the Commander, Sector North Carolina.
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard commissioned, warrant, or petty officer
designated by the Captain of the Port North Carolina (COTP) for the
enforcement of the safety zone.
    Work crews means persons and vessels involved in the bridge
maintenance project.
    (c) Regulations. (1) The general regulations governing safety zones
in Sec.  165.23 apply to the areas described in paragraph (a) of this
section.
    (2) With the exception of work crews, entry into or remaining in
either safety

zone is prohibited unless authorized by the COTP North Carolina or the
COTP North Carolina's designated representative. All other vessels must
depart the zone(s) immediately upon activation.
    (3) Larger vessels may request maintenance equipment be relocated
outside of the navigable channel if at least a 48-hour notice is given.
This advance notice shall be given to the bridge tender at (910) 251-
5774 or via VHF-FM marine channel 13 (165.65 MHz).
    (4) The Captain of the Port, North Carolina can be reached through
the Coast Guard Sector North Carolina Command Duty Officer, Wilmington,
North Carolina at telephone number<PHONE_NUMBER>.
    (5) The Coast Guard and designated security vessels enforcing the
safety zone can be contacted on VHF-FM marine band radio channel 13
(165.65 MHz) and channel 16 (156.8 MHz).
    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the safety zone by Federal, State, and local
agencies.
    (e) Enforcement periods. This section will be enforced for:
    (1) Safety Zone 1 from December 15, 2019 through February 15, 2020;
and
    (2) Safety Zone 2 from 6 a.m. through 6 p.m. on days when power
cables are being placed under the navigable channel.
    (f) Public notification. The Coast Guard will notify the public of
the active enforcement times at least 48 hours in advance by
transmitting Broadcast Notice to Mariners via VHF-FM marine channel 16.

    Dated: December 11, 2019.
Bion B. Stewart,
Captain, U.S. Coast Guard, Captain of the Port North Carolina.
[FR Doc. 2019-27063 Filed 12-13-19; 8:45 am]
 BILLING CODE 9110-04-P