[Federal Register Volume 84, Number 41 (Friday, March 1, 2019)]
[Rules and Regulations]
[Pages 6972-6974]
[FR Doc No: 2019-03717]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-1081]
RIN 1625-AA67

Security Zones; Dignitary Arrival/Departure and United Nations
Meeting, New York, NY

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is modifying the Marine Air Terminal,
LaGuardia Airport Security Zone to expand the existing security zone
boundary north along the Rikers Island Bridge to the intersecting point
on the southern tip of Rikers Island then east to the western end of
LaGuardia Airport. This expanded security zone is necessary to protect
the port, waterfront facilities, and waters of the United States from
terrorism, sabotage, or other subversive acts and incidents of a
similar nature during visits to New York City by various dignitaries.

DATES: This rule is effective April 1, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2017-1081 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MST1 Kristina Pundt, Sector New York Waterways Division,
U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    On September 29, 2014, the Coast Guard published an NPRM with a
request for comments entitled, ``Security Zones; Dignitary Arrival/
Departure and United Nations Meetings, New York, NY'' in the Federal
Register (79 FR 58298). This NPRM proposed to disestablish three RNAs
and replace

each with a security zone. No comments nor requests for a public
meeting were received. On December 30, 2014 the Coast Guard published a
Final Rule titled, ``Security Zones; Dignitary Arrival/Departure and
United Nations Meetings, New York, NY'' in the Federal Register (79 FR
78308). This final rule disestablished the RNAs and replaced them with
three security zones. One of the security zones established was the
Marine Air Terminal, LaGuardia Airport security zone.
    On May 22, 2018, the Coast Guard published an NPRM titled,
``Security Zones; Dignitary Arrival/Departure and United Nations
Meetings, New York, NY'' in the Federal Register (83 FR 23619). This
NPRM proposed to modify the existing Marine Air Terminal, LaGuardia
Airport security zone due to location adjustments of security staging
areas, and invited comments on our proposed regulatory action related
to this security zone. During the comment period that ended July 23,
2018, the Coast Guard received no comments.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under the authority in 33
U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33
CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Public Law 107-295, 116 Stat. 2064;
and Department of Homeland Security Delegation No. 0170.1. Due to
location adjustments of the security staging areas, the Coast Guard has
determined that the existing security zone does not provide an adequate
level of security. The modification will allow enforcement of a
security zone that will minimize threat exposure. The purpose of this
rule is to protect the port, waterfront facilities, and waters of the
United States from terrorism, sabotage, or other subversive acts and
incidents of a similar nature during visits to New York City by various
dignitaries.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received no comments on our NPRM published May
22, 2018. There are no changes in the regulatory text of this rule from
the proposed rule in the NPRM.
    This rule modifies an existing security zone. The modification
expands the existing security zone boundary north along the Rikers
Island Bridge to the intersecting point on the southern tip of Rikers
Island then east to the western end of LaGuardia Airport.

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 limited size
and enforcement of the security zone. Although expanding upon the
current security zone, the modification only encompasses a small
designated area of Bowery Bay. Additionally, the security zone will
only be enforced during the infrequent visits of domestic and foreign
dignitaries for as limited duration as necessary to safeguard against
destruction, loss, or injury from sabotage or other subversive acts,
accidents, or other causes of a similar nature. Moreover, the Coast
Guard will issue a Broadcast Notice to Mariners via VHF-FM marine
channel 16 about the zone and the rule would allow vessels to seek
permission to transit 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
security 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
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive
Order13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.

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 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This rule involves
the modification of a security zone that would prohibit entry into
Bowery Bay for a limited duration and for a limited number of instances
each year. 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. 01. 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 contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

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

0
2. In Sec.  165.164, revise paragraph (a)(3) to read as follows:

Sec.  165.164  Security Zones; Dignitary Arrival/Departure and United
Nations Meetings, New York, NY.

    (a) * * *
    (3) Marine Air Terminal, LaGuardia Airport Security Zone. All
waters of Bowery Bay, Queens, New York, inside of a line drawn from the
start of the Rikers Island Bridge in Queens at approximate position
40[deg]46'37'' N, 073[deg]53'30'' W to the intersecting point on the
southern side of Rikers Island at approximate position 40[deg]47'12''
N, 073[deg]53'06'' W, then a line drawn east to the western end of
LaGuardia Airport at approximate position 40[deg]47'00'' N,
073[deg]52'44'' W, then a line drawn south following the shoreline back
to the point of origin at 40[deg]46'37'' N, 073[deg]53'30'' W (NAD
1983).
* * * * *

    Dated: December, 4, 2018.
J.P. Tama,
Captain, U.S. Coast Guard, Captain of the Port New York.
[FR Doc. 2019-03717 Filed 2-28-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8872-8874]
[FR Doc No: 2015-03419]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2138]

Adverse Event Reporting for Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a draft guidance for industry entitled
``Adverse Event Reporting for Outsourcing Facilities Under Section 503B
of the Federal Food, Drug, and Cosmetic Act.'' Under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must
submit adverse event reports to FDA. This guidance explains FDA's
current thinking on adverse event reporting for outsourcing facilities.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work to finalize the guidance, submit
either electronic or written comments on this draft guidance by May 20,
2015. Submit either electronic or written comments concerning the
collection of information proposed in the draft guidance by May 20,
2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,

4th Floor, Silver Spring, MD 20993. Send one self-addressed adhesive
label to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
    Submit electronic comments on the draft 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: H. Joy Sharp, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Adverse Event Reporting for Outsourcing Facilities Under
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' On November
27, 2013, President Obama signed the Drug Quality and Security Act
(DQSA) into law (Pub. L. 113-54). The DQSA added a new section 503B to
the FD&C Act (21 U.S.C. 353b). Under section 503B(b), a compounder can
register as an outsourcing facility with FDA. Section 503B(d)(4) of the
FD&C Act defines an outsourcing facility, in part, as a facility that
complies with all of the requirements of section 503B, including
registering with FDA as an outsourcing facility and paying associated
fees. If the conditions outlined in section 503B(a) of the FD&C Act are
satisfied, a drug compounded by or under the direct supervision of a
licensed pharmacist in an outsourcing facility is exempt from certain
sections of the FD&C Act, including section 502(f)(1) (21 U.S.C.
352(f)(1)) (concerning the labeling of drugs with adequate directions
for use) and section 505 (21 U.S.C. 355) (concerning the approval of
human drug products under new drug applications (NDAs) or abbreviated
new drug applications (ANDAs)). Drugs compounded in outsourcing
facilities are not exempt from the requirements of section 501(a)(2)(B)
of the FD&C Act (21 U.S.C. 351(a)(2)(B)) (concerning current good
manufacturing practice for drugs).
    Under section 503B(b)(5), an outsourcing facility must submit
adverse event reports to FDA in accordance with the content and format
requirements established through guidance or regulation under section
310.305 of title 21, Code of Federal Regulations (or any successor
regulations). This draft guidance explains how FDA intends to implement
Sec.  310.305 with respect to outsourcing facilities.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent 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. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information that
they conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
    With respect to the collection of information associated with this
document, FDA invites comments on the following topics: (1) Whether the
proposed information collected is necessary for the proper performance
of FDA's functions, including whether the information will have
practical utility; (2) the accuracy of FDA's estimated burden of the
proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Under the draft guidance, registered outsourcing facilities must
submit to FDA adverse event reports within 15 calendar days of
receiving the information and must submit a followup report within 15
calendar days of receipt of new information about the adverse event, or
as requested by FDA. Outsourcing facilities must submit the adverse
event report using the existing Form FDA 3500A (which is approved by
OMB control number 0910-0291) or an alternate method in accordance with
Sec.  310.305(d). A copy of the current labeling of the compounded drug
product must be included. Each form should be submitted with a cover
letter that includes the following heading: ``Adverse event report
submitted by human drug compounding outsourcing facility (503B).''
    Under Sec.  310.305, entities subject to the regulation must
maintain for 10 years the records of all adverse events required to be
reported under Sec.  310.305, including raw data and any correspondence
relating to the adverse event. The outsourcing facility should also
maintain records of its efforts to obtain the data elements described
in the draft guidance for each adverse event report.
    The total estimated reporting and recordkeeping burdens for the
draft guidance are as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                    Average burden
        Type of reporting            Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses        (hours)
----------------------------------------------------------------------------------------------------------------
Submission of adverse event                   50               2             100             1.1             110
 reports including cover letter,
 copy of labeling, and other
 information as described in the
 draft guidance.................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             110
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                Average burden
                                                                        Number of        Number of       Total annual         per
                       Type of recordkeeping                          recordkeepers     records per        records       recordkeeping     Total hours
                                                                                recordkeeper                        (hours)
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Records of adverse events, including records of efforts to obtain                50                1               50               16              800
 the data elements for each adverse event report...................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. 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
can 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.

IV. Electronic Access

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

    Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03419 Filed 2-18-15; 8:45 am]
BILLING CODE 4164-01-P