[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Proposed Rules]
[Pages 20559-20563]
[FR Doc No: 2013-07909]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0026]
RIN 1625-AA00

Safety Zones; Swim Events in the Captain of the Port New York
Zone; Hudson River, East River, Upper New York Bay, Lower New York Bay;
New York, NY

AGENCY: Coast Guard, DHS.

ACTION: Notice of Proposed Rulemaking.

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SUMMARY: The Coast Guard proposes to establish five temporary safety
zones for swim events within the Captain of the Port (COTP) New York
Zone. These proposed zones will be established on the navigable waters
of the Hudson River, East River, Upper New York Bay, and Lower New York
Bay. These temporary safety zones are necessary to protect the maritime
public and event participants from the hazards associated with these
events. Persons and vessels are prohibited from entering into,
transiting through, mooring, or anchoring within the safety zones
unless authorized by the COTP New York or the designated
representative.

DATES: Comments and related material must be received by the Coast
Guard on or before June 4, 2013.

ADDRESSES: You may submit comments identified by docket number using
any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Junior Grade Kristopher Kesting, Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you
have questions on viewing or submitting material to the docket, call
Barbara Hairston, Program Manager, Docket Operations, telephone (202)
366-9826.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number (USCG-2013-0026) in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a

Comment'' on the line associated with this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2013-0026) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one on or before April 12, 2013 using one of the methods
specified under ADDRESSES. Please explain why you believe a public
meeting would be beneficial. If we determine that one would aid this
rulemaking, we will hold one at a time and place announced by a later
notice in the Federal Register.

B. Regulatory History and Information

    In previous years, the Coast Guard has established special local
regulations, regulated areas, and safety zones on a case-by-case basis
to ensure the protection of the maritime public and event participants
from hazards associated with these events. The Coast Guard has not
received public comments or concerns regarding the impact to waterway
traffic from these events.

C. Basis and Purpose

    The legal basis for the proposed rule is 33 U.S.C. 1266, 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, and 160.5; Public Law 107-295, 116 Stat. 2064; and
Department of Homeland Security Delegation No. 0170.1, which
collectively authorize the Coast Guard to define regulatory safety
zones.
    Marine events are frequently held on the navigable waters within
the COTP Sector New York Zone. The COTP has determined that swimming
events in close proximity to marine traffic pose significant risk to
public safety and property. The combination of increased numbers of
recreation vessels, congested waterways, and large numbers of swimmers
in the water has the potential to result in serious injuries or
fatalities. In order to protect the safety of all waterway users
including event participants and spectators, this temporary rule
establishes temporary safety zones for the duration of the events.
    This rule prevents vessels from entering into, transiting through,
and mooring or anchoring within the areas specifically designated as
the regulated areas during the periods of enforcement unless authorized
by the COTP, or the designated representative.

D. Discussion of Proposed Rule

    This temporary rule creates safety zones for five swim events on
the navigable waters of the Hudson River, East River, Upper New York
Bay and Lower New York Bay. A portion of the navigable waters will be
closed during the effective periods to all vessel traffic except local,
state or Coast Guard patrol crafts. The events and locations are as
follows:
    (1) Hudson Valley Triathlon: Waters of the Hudson River in the
vicinity of Ulster Landing, NY.
    (2) Coney Island to New Dorp Beach Swim: Waters of the Lower New
York Bay spanning from Rockaway Point, Coney Island to New Dorp Beach,
Staten Island.
    (3) Brooklyn Bridge Swim: Waters of the East River in the vicinity
of Brooklyn Bridge Park, Brooklyn, NY and East River Park, New York,
NY.
    (4) The Liberty to Freedom Swim: Waters of the Upper New York Bay,
from Liberty Island, NJ to North Cove, New York, NY.
    (5) Ederle Swim: Waters of the Hudson River between North Cove
Marina, New York, NY and Sandy Hook, NJ.
    The proposed regulation would prevent vessels from transiting in
close proximity to swimmers in areas designated as safety zones during
the periods of enforcement to ensure protection of the maritime public
and event participants from hazards associated with the listed swim
events.
    Event sponsors, designated participants, and official patrol
vessels will be allowed to enter the regulated areas. Spectators and
other vessels not registered as event participants will not be
permitted to enter the safety zones without permission of the COTP or
the designated representative. Marine traffic will be permitted to pass
through safety zones at a safe distance from event participants with
permission of the COTP or the designated representative.

E. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    These safety zones will be of limited duration, and vessels may
transit in portions of the affected waterway. Furthermore, vessels may
be authorized to transit these zones with the permission of the COTP
New York or the designated representative.
    Notifications will be made to the local maritime community through
the Local Notice to Mariners and Broadcast Notice to Mariners well in
advance of the events. No new or additional restrictions would be
imposed on vessel traffic.

2. Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered the impact of this proposed rule on small entities. The
Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule
will not have a significant economic impact on a substantial number of
small entities.
    This rule will affect the following entities, some of which may be
small

entities: The owners and operators of vessels intending to transit,
fish or anchor in the designated safety zones during the enforcement
period of the swim events.
    The safety zones will not have significant economic impact on a
substantial number of small entities for the following reasons: Vessels
will only be restricted from safety zone areas for a short duration of
time; vessels may transit in portions of the affected waterway at a
safe distance from event participants with permission of the COTP or
the designated representative; the Coast Guard has promulgated safety
zones in accordance with 33 CFR part 165 for all event areas in the
past and has not received notice of any negative impact caused by any
of the safety zones; and notifications will be made to the local
maritime community through the Local Notice to Mariners and Broadcast
Notice to Mariners well in advance of the events.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    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 proposed 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, above. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

4. Collection of Information

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

5. Federalism

    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 proposed rule under that Order and
determined that this rule does not have implications for federalism.

6. 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.

7. 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 proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

8. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination 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 proposed rule
involves the establishment of five temporary safety zones for swim
events. This proposed rule may be categorically excluded from further
review under paragraph 34(g) of Figure 2-1 of the Commandant
Instruction. A preliminary environmental analysis checklist supporting
this determination is available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 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; 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; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1, which authorizes the Coast Guard to define Safety Zone
Regulations.

0
2. Add Sec.  165.T01-0026 to read as follows:

Sec.  165.T01-0026  Swim Events in the Captain of the Port New York
Zone, Hudson River, East River, Upper New York Bay, Lower New York Bay,
New York, NY.

    (a) Regulation. The general regulations contained in 33 CFR 165.23
as well as the following regulations apply to the swim events listed in
the TABLE to 165.T01-0026. These regulations will be enforced for the
duration of each swim event. Notifications of exact dates and times of
the enforcement period will be made to the local maritime community in
the final rule. First Coast Guard District Local Notice to Mariners can
be found at http://www.navcen.uscg.gov/.
    (b) Definitions. The following definitions apply to this section:
    (1) Designated Representative. A designated representative is any
Coast Guard commissioned, warrant or petty officer of the U.S. Coast
Guard who has been designated by the Captain of the Port (COTP) New
York Zone to act on his or her behalf.
    (2) Official Patrol Vessels. Official patrol vessels may consist of
any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement
vessels assigned or approved by the COTP. The designated representative
may be on an official patrol vessel or may be on shore and will
communicate with vessels via VHF-FM radio or loudhailer. In addition,
members of the Coast Guard Auxiliary may be present to inform vessel
operators of this regulation.
    (3) Spectators. All persons and vessels not registered with the
event sponsor as participants or official patrol vessels.
    (c) Vessel operators desiring to enter or operate within the
regulated areas shall contact the COTP or the designated representative
via VHF channel 16 or<PHONE_NUMBER> (Sector New York command center) to
obtain permission to do so.
    (d) Spectators or other vessels shall not anchor, block, loiter
within, or impede the transit of event participants or official patrol
vessels in the regulated areas during the effective dates and times, or
dates and times as modified through the Local Notice to Mariners,
unless authorized by COTP or the designated representative.
    (e) Upon being hailed by a U.S. Coast Guard vessel or the
designated representative, by siren, radio, flashing light or other
means, the operator of the vessel shall proceed as directed. Failure to
comply with a lawful direction may result in expulsion from the area,
citation for failure to comply, or both.
    (f) The COTP or the designated representative may delay or
terminate any marine event in this subpart at any time it is deemed
necessary to ensure the safety of life or property.
    (g) For all swim events listed in the TABLE to Sec.  165.T01-0026,
vessels not associated with the event that are permitted to enter the
regulated areas in accordance with section (c), shall maintain a
separation of at least 100 yards from the participants.

                     Table 1 to Sec.   165.T01-0026
------------------------------------------------------------------------

------------------------------------------------------------------------
1                                                  Hudson River
------------------------------------------------------------------------
1.1 Hudson Valley Triathlon............   Date: July 14, 2013.
                                          Location site: All
                                          waters of the Hudson River in
                                          the vicinity of Ulster
                                          Landing, bound by the
                                          following points:
                                          42[deg]00'03.7'' N,
                                          073[deg]56'43.1'' W; thence to
                                          41[deg]59'52.5'' N,
                                          073[deg]56'34.2'' W; thence to
                                          42[deg]00'15.1'' N,
                                          073[deg]56'25.2'' W; thence to
                                          42[deg]00'05.4'' N,
                                          073[deg]56'41.9'' W; thence
                                          along the shoreline to the
                                          point of origin.
------------------------------------------------------------------------
2                                               Lower New York Bay
------------------------------------------------------------------------
2.1 Coney Island to New Dorp Beach Swim   Date: October 14, and
                                          27, 2013.
                                          Location: All waters
                                          of the Lower New York Bay
                                          spanning from Rockaway Point,
                                          Coney Island to New Dorp
                                          Beach, Staten Island, bound by
                                          the following points:
                                          40[deg]32'33.69'' N,
                                          073[deg]56'25.32'' W; thence
                                          to 40[deg]26'50.97'' N,
                                          073[deg]59'01.05'' W; thence
                                          to 40[deg]28'52.26'' N,
                                          074[deg]0'21.97'' W; thence to
                                          40[deg]34'13.48'' N,
                                          074[deg]0'07.18'' W; thence
                                          back to the point of origin.
------------------------------------------------------------------------
3                                        East River, Upper New York Bay,
                                                Lower New York Bay
------------------------------------------------------------------------
3.1 Brooklyn Bridge Swim...............   Date: July 07, 2013.
                                          Rain Date: NA.
                                          Location: All waters
                                          of the East River, bound by
                                          the following points:
                                          40[deg]42'17.04'' N,
                                          073[deg]59'21.87'' W; thence
                                          to 40[deg]42'12.03'' N,
                                          073[deg]59'46.17'' W; thence
                                          to 40[deg]42'24.48'' N,
                                          074[deg]0'4.09'' W; thence to
                                          40[deg]42'34.19 N,
                                          073[deg]59'31.41'' W; thence
                                          back to point of origin.
------------------------------------------------------------------------
4                                           Upper New York Bay, Hudson
                                                       River
------------------------------------------------------------------------
4.1 Liberty to Freedom Swim............   Date: September 08,
                                          2013.
                                          Location: All waters
                                          of the East River, bound by
                                          the following points:
                                          40[deg]42'17.04'' N,
                                          073[deg]59'21.87'' W; thence
                                          to 40[deg]42'12.03'' N,
                                          073[deg]59'46.17'' W; thence
                                          to 40[deg]42'24.48'' N,
                                          074[deg]0'4.09'' W; thence to
                                          40[deg]42'34.19N,
                                          073[deg]59'31.41'' W; thence
                                          back to point of origin.
------------------------------------------------------------------------
5                                           Upper New York Bay, Hudson
                                                 River [Reserved]
------------------------------------------------------------------------
6                                         Upper New York Bay, Lower New
                                                     York Bay
------------------------------------------------------------------------
6.1 Ederle Swim........................   Date: August 18, 19
                                          and 22, 2013.

                                          Location: All waters
                                          of the Hudson River, Upper and
                                          Lower New York Bays, bound by
                                          the following points:
                                          40[deg]42'48.13'' N,
                                          074[deg]0'58.74'' W; thence to
                                          40[deg]42'3.20'' N,
                                          073[deg]59'54.84'' W; thence
                                          to 40[deg]36'32.70'' N,
                                          074[deg]2'10.73'' W; thence to
                                          40[deg]28'4.43 N,
                                          073[deg]59'38.14'' W; thence
                                          to 40[deg]28'41.58'' N,
                                          074[deg]0'55.27'' W; thence to
                                          40[deg]38'38.77'' N,
                                          074[deg]4'15.05'' W; thence to
                                          40[deg]43'0.31'' N,
                                          074[deg]1'48.11'' W thence
                                          back to point of origin.
------------------------------------------------------------------------

    Dated: March 2, 2013.
G. Loebl,
Captain, U.S. Coast Guard, Captain of the Port New York.
[FR Doc. 2013-07909 Filed 4-4-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: June 11, 2010 (Volume 75, Number 112)]
[Notices]
[Page 33374]
[DOCID:fr11jn10-125]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold an Open Meeting on June 16, 2010 at
10 a.m., in the Auditorium, Room L-002.
    The subject matter of the Open Meeting will be: The Commission will
consider whether to propose amendments to rules 156 and 482 under the
Securities Act of 1933 and rule 34b-1 under the Investment Company Act
of 1940 to address concerns that have been raised about target date
retirement fund names and marketing materials.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: June 8, 2010.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-14148 Filed 6-9-10; 11:15 am]
BILLING CODE 8011-01-P


MEMORANDUM

DATE:		July 7, 2014

TO:		Carbon Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Amy Zimpfer, EPA R9

SUBJECT:	June 10, 2014 Telephone Call Regarding Proposed Clean Power Plan  --------------------------------------------------------------------------------

SUMMARY

      A telephone discussion was held on June 10, 2014 with Edie Chang, CARB Deputy EO, regarding scheduling a meeting to discuss EPA's proposed Clean Power Plan with California officials.  No materials were provided or received.                 ATTENDEES Amy Zimpfer, EPA (by phone) Edie Chang, ARB (by phone)


[Federal Register Volume 84, Number 76 (Friday, April 19, 2019)]
[Notices]
[Pages 16512-16513]
[FR Doc No: 2019-07930]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0621]

Bispecific Antibody Development Programs; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Bispecific
Antibody Development Programs.'' This draft guidance provides
recommendations to assist industry and other parties involved in the
bispecific antibody drug development process. The draft guidance
focuses on general regulatory and scientific considerations for
bispecific antibodies, but not on development of a particular
bispecific antibody. Industry and other stakeholders are encouraged to
engage FDA to discuss their individual bispecific antibody under
development.

DATES: Submit either electronic or written comments on the draft
guidance by June 18, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-0621 for ``Bispecific Antibody Development Programs.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the 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 20993-0002; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 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.

FOR FURTHER INFORMATION CONTACT: Ebla Ali-Ibrahim, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6302, Silver Spring, MD 20993, 301-796-
3691; or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Bispecific Antibody Development Programs.'' This draft
guidance provides recommendations to assist those involved in the
bispecific antibody drug development process. This draft guidance
discusses general considerations and recommendations, as well as
regulatory, quality, nonclinical, and clinical considerations in the
context of bispecific antibody development programs. This draft
guidance does not discuss development considerations for other
multitarget therapies that are combinations of monoclonal antibodies,
antibody cocktails, or polyclonal antibodies.
    Since the first therapeutic monoclonal antibody was commercialized
in 1986, monoclonal antibodies have become a vital component of therapy
for various diseases and conditions including cancer, autoimmune and
infectious diseases, and inflammatory conditions. The regulatory
pathway for evaluation of monoclonal antibodies is well established,
but additional draft guidance is needed about antibody-based products
that target more than one antigen. Advances in technology and an
interest in novel therapies that combine targets have led to the
development of bispecific antibodies, which are genetically engineered,
recombinant antibodies that consist of two distinct binding domains
capable of binding two different antigens or two different epitopes of
the same antigen.
    There are a number of challenges in developing bispecific
antibodies, one of which may be significant immunogenicity caused by
novel epitopes. This draft guidance addresses these considerations and
provides recommendations regarding the type of data necessary to
support the approval of bispecific antibodies.
    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 current thinking of FDA on ``Bispecific
Antibody Development Programs.'' It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 312 have been approved under
0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: April 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07930 Filed 4-18-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Proposed Rules]
[Pages 46679-46681]
[FR Doc No: 2018-19797]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0839; Product Identifier 2017-NE-31-AD]
RIN 2120-AA64

Airworthiness Directives; Zodiac Seats France, Cabin Attendant
Seats

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Zodiac Seats France 536-Series Cabin Attendant Seats. This proposed AD
was prompted by potential risk of premature corrosion on the seat
structure and clamps. This proposed AD would require inspection and
modification of all Zodiac Seats France 536-Series Cabin Attendant
Seats. We are proposing this AD to address the unsafe condition on
these products.

DATES: We must receive comments on this proposed AD by October 29,
2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12 140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Zodiac
Service Europe, 61, rue Pierre Curie, 78 373 Plaisir, France; phone:
+33 (0)1 61 34 19 58; email: [email protected]; website:
https://www.zodiacaerospace.com/en/zodiac-aerospace-services/contacts.You may view this service information at the FAA, Engine and
Propeller Standards Branch, 1200 District Avenue, Burlington, MA 01803.
For information on the availability of this material at the FAA, call
781-238-7759.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0839; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the mandatory continuing airworthiness information (MCAI),
the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (phone: 800-647-
5527) is listed above. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Dorie Resnik, Aerospace Engineer,
Boston ACO Branch, FAA, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2017-0839;
Product Identifier 2017-NE-31-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM because
of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this NPRM.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD 2016-0167, dated August 17, 2016 (referred to after this as ``the
MCAI''), to address the unsafe condition on these products. The MCAI
states:

    Cases of corrosion and cracks were found on Zodiac Seats France
CAS 536 rear cabin attendant seats installed on some ATR 42 and ATR
72 aeroplanes. The detected damage was located on the lower parts of
the attendant seat, at the level of the seat-to-floor interface.
This condition, if not detected and corrected, could lead to failure
of the seat

occupied by the cabin attendant, possibly resulting in injury to the
seat occupant. To address this potential unsafe condition, Zodiac
Seats France issued Service Bulletin (SB) No. 536-25-002 to provide
inspection instructions.
    For the reason described above, this [EASA] AD requires
repetitive inspections of the affected attendant seats, and,
depending on findings, accomplishment of the temporary corrective
action(s). This [EASA] AD is considered as interim action and
further [EASA] AD action may follow. Zodiac Seats France is
developing a solution preventing this kind of damage.

    You may obtain further information by examining the MCAI in the AD
docket on the internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2017-0839.

Related Service Information Under 1 CFR Part 51

    We reviewed Zodiac Seats France Service Bulletin (SB) No. 536-25-
002, Revision 3, dated September 30, 2016. The SB describes procedures
for inspection, repair, or replacement of the seat structure and clamps
known to be installed on the main structure. This service information
is reasonably available because the interested parties have access to
it through their normal course of business or by the means identified
in the ADDRESSES section.

FAA's Determination

    This product has been approved by EASA, and is approved for
operation in the United States. Pursuant to our bilateral agreement
with the European Community, EASA has notified us of the unsafe
condition described in the MCAI and service information referenced
above. We are proposing this AD because we evaluated all the relevant
information provided by EASA and determined the unsafe condition
described previously is likely to exist or develop in other products of
the same type design.

Proposed AD Requirements

    This proposed AD would require inspection and modification of all
Zodiac Seats France 536-Series Cabin Attendant Seats.

Costs of Compliance

    We estimate that this proposed AD affects 55 seat structures
installed on, but not limited to, ATR 42 and ATR 72 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Seat inspection, visual (on-wing).....  0.2 work-hours x $85 per              $0             $17            $935
                                         hour = $17.
Seat inspection, (shop visit).........  0.5 work-hours x $85 per               0           42.50        2,337.50
                                         hour = $42.50.
Part replacement/repair...............  2.0 work-hours x $85 per           2,000           2,170         119,350
                                         hour = $170.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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):

Zodiac Seats France (formerly SICMA Aero Seat): Docket No. FAA-2017-
0839; Product Identifier 2017-NE-31-AD.

(a) Comments Due Date

    We must receive comments by October 29, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Zodiac Seats France, 536-Series Cabin
Attendant Seats, part number (P/N) 53600, all dash numbers, all
serial numbers. These appliances are installed on, but not limited
to, Avions de transport regional (ATR) 42 and ATR 72 airplanes of
U.S. registry.

(d) Subject

    Joint Aircraft System Component (JASC) Code 2500, Cabin
Equipment/Furnishings.

(e) Unsafe Condition

    This AD was prompted by corrosion found on the seat structure or
on clamps of the Zodiac Seats France 536-Series Cabin Attendant
Seats. We are issuing this AD to prevent failure of these seats. The
unsafe condition, if not addressed, could result in failure of the
seat occupied by the cabin attendant, and possible injury to the
seat occupant.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    (1) Within 14 months after the first installation of the seat on
an aircraft, or within three months after the effective date of this
AD, whichever occurs later, remove the seat from the aircraft and
perform a detailed visual inspection in accordance with the
Accomplishment Instructions, Paragraph 2.B., of Zodiac Seats France
Service Bulletin (SB) No. 536-25-002, Revision 3, dated September
30, 2016. If the date of the first installation of a seat on an
airplane is unknown, use the date of manufacture of the seat (which
can be found on the ID placard of the seat) to determine when the
inspection must be accomplished.
    (2) Within three months after the inspection required by
paragraph (g)(1) of this AD, and, thereafter, at intervals not to
exceed three months, perform a detailed visual inspection in
accordance with the Accomplishment Instructions, Paragraphs 2.A. and
2.B., of Zodiac Seats France SB No. 536-25-002, Revision 3, dated
September 30, 2016.
    (3) If corrosion or other damage is found, before further flight
or before reinstallation of the seat on an aircraft, as applicable,
repair the seat in accordance with the Accomplishment Instructions,
Paragraphs 2.B. and 2.C., of Zodiac Seats France SB No. 536-25-002,
Revision 3, dated September 30, 2016.
    (4) Temporarily stowing and securing a damaged attendant seat in
a retracted position to prevent occupancy, in accordance with the
provisions and limitations applicable Master Minimum Equipment List
item, is an acceptable alternative method to defer compliance with
the requirements of paragraph (g)(3) of this AD.

(h) Installation Prohibition

    After the effective date of this AD, do not install an affected
Zodiac Seats France 536-Series Cabin Attendant Seat on any aircraft,
unless having accumulated more than 14 months since first
installation on any aircraft, provided that before installation, it
has passed an inspection in accordance with the Accomplishment
Instructions, Paragraph 2.B., of Zodiac Seats France SB No. 536-25-
002, Revision 3, dated September 30, 2016.

(i) Credit for Previous Actions

    You may take credit for actions required by paragraph (g) of
this AD if you performed these actions before the effective date of
this AD using Zodiac Seats France SB No. 536-25-002, Revision 2,
dated August 29, 2016.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Boston ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the ACO Branch, send it to the attention of the person
identified in paragraph (k)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    (1) For more information about this AD, contact Dorie Resnik,
Aerospace Engineer, Boston ACO Branch, FAA, 1200 District Avenue,
Burlington, MA, 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email: [email protected].
    (2) Refer to European Aviation Safety Agency AD 2016-0167, dated
August 17, 2016, for more information. You may examine the EASA AD
in the AD docket on the internet at http://www.regulations.gov by
searching for and locating it in Docket No. FAA-2017-0839.
    (3) For service information identified in this AD, contact
Zodiac Service Europe, 61, rue Pierre Curie, 78 373 Plaisir, France;
phone: +33 (0)1 61 34 19 58; email: [email protected];
website: https://www.zodiacaerospace.com/en/zodiac-aerospace-services/contacts. You may view this referenced service information
at the FAA, Engine and Propeller Standards Branch, 1200 District
Avenue, Burlington, MA, 01803. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on September 5, 2018.
Robert J. Ganley,
Manager, Engine and Propeller Standards Branch, Aircraft Certification
Service.
[FR Doc. 2018-19797 Filed 9-13-18; 8:45 am]
 BILLING CODE 4910-13-P