[Federal Register: July 30, 2009 (Volume 74, Number 145)]
[Proposed Rules]
[Page 37971-37973]
[DOCID:fr30jy09-20]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 135

[Docket No. FAA-2009-0023; Notice No. 09-02A]
RIN 2120-AJ32

Crew Resource Management Training for Crewmembers in Part 135
Operations

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking; extension of comment period.

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SUMMARY: This action extends the comment period for a proposed rule
that was published on May 1, 2009. The proposed rule would require all
certificate holders conducting operations under part 135 to include in
their training programs crew resource management for crewmembers,
including pilots and flight attendants. This proposal is needed to
ensure that crewmembers in part 135 operations receive training and
practice in the use

of crew resource management principles, as appropriate for their
operation. This proposed rule would respond to National Transportation
Safety Board recommendations, address a recommendation from the Part
125/135 Aviation Rulemaking Committee, and would codify current FAA
guidance. The intended effect of this proposal is to reduce the
frequency and severity of errors that are crew based, which will reduce
the frequency of accidents and incidents within the scope of part 135
operations. The FAA is seeking further comment on this proposed rule
because all of the rulemaking documents were not available in the
official docket.

DATES: Comments, identified by docket number FAA-2009-0023, must be
received on or before September 28, 2009.

ADDRESSES: You may send comments identified by docket number FAA-2009-
0023 using any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue, SE., Room W12-
140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Bring comments to the Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to the Docket Operations at 202-493-
2251.

For more information on the rulemaking process, see the SUPPLEMENTARY
INFORMATION section of this document.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://
DocketsInfo.dot.gov.
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time and follow the online
instructions for accessing the docket, or to the Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this proposed rule, contact Nancy Lauck Claussen, Federal Aviation
Administration, Flight Standards Service, Air Transportation Division
(AFS-200), 800 Independence Avenue, SW., Washington, DC 20591;
Telephone:<PHONE_NUMBER>; E-mail<EMAIL_ADDRESS>For legal
questions concerning this proposed rule, contact Anne Bechdolt, Federal
Aviation Administration, Office of the Chief Counsel, 800 Independence
Avenue, SW., Washington, DC 20591; Telephone:<PHONE_NUMBER>; E-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. We also
invite comments relating to the economic, environmental, energy, or
federalism impacts that might result from adopting the proposals in
this document. The most helpful comments reference a specific portion
of the proposal, explain the reason for any recommended change, and
include supporting data. To ensure the docket does not contain
duplicate comments, please send only one copy of written comments, or
if you are filing comments electronically, please submit your comments
only one time.
    We will file in the docket all comments we receive, as well as a
report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Proprietary or Confidential Business Information

    Do not file in the docket information that you consider to be
proprietary or confidential business information. Send or deliver this
information directly to the person identified in the FOR FURTHER
INFORMATION CONTACT section of this document. You must mark the
information that you consider proprietary or confidential. If you send
the information on a disk or CD-ROM, mark the outside of the disk or
CD-ROM and also identify electronically within the disk or CD-ROM the
specific information that is proprietary or confidential.
    Under 14 CFR 11.35(b), when we are aware of proprietary information
filed with a comment, we do not place it in the docket. We hold it in a
separate file to which the public does not have access, and we place a
note in the docket that we have received it. If we receive a request to
examine or copy this information, we treat it as any other request
under the Freedom of Information Act (5 U.S.C. 552). We process such a
request under the DOT procedures found in 49 CFR part 7.

Availability of Rulemaking Documents

    You can get an electronic copy of rulemaking documents using the
Internet by--
    1. Searching the Federal eRulemaking Portal (http://
www.regulations.gov);
    2. Visiting the FAA's Regulations and Policies Web page at http://
www.faa.gov/regulations_policies or
    3. Accessing the Government Printing Office's Web page at http://
www.gpoaccess.gov/fr/index.html.
    You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>. Make
sure to identify the docket number or notice number of this rulemaking.
    You may access all documents the FAA considered in developing this
proposed rule, including economic analyses and technical reports, from
the internet through the Federal eRulemaking Portal referenced in
paragraph 1.

Background

    On May 1, 2009 (74 FR 20263) the FAA published a proposed rule that
would require all certificate holders conducting operations under part
135 to include in their training programs crew resource management for
crewmembers, including pilots and flight attendants. The comment period
for the proposed rule closes on July 30, 2009. Because the regulatory
evaluation for the proposed rule was not available for review in the
docket until July 24, 2009, the FAA is extending the comment period
from July 30, 2009 to September 28, 2009.

Extension of Comment Period

    The FAA wants to ensure that the proposed rulemaking and all its
associated documents have been

adequately available for public viewing and comment. Because the
regulatory evaluation contains information regarding the expected
benefits and costs of this rulemaking, the FAA has determined that a
60-day extension of the comment period is necessary to give the public
adequate time to review this document. Such action is, in the public
interest, and good cause exists for taking this action. Accordingly,
the comment period for Notice No. 09-02 is extended until September 28,
2009.

    Issued in Washington, DC, on July 27, 2009.
Julie A. Lynch,
Acting Director, Office of Rulemaking.
[FR Doc. E9-18322 Filed 7-29-09; 8:45 am]

BILLING CODE 4910-13-P


From:	Kevin Culligan/DC/USEPA/US

To:	"Mancini, Dominic J."<EMAIL_ADDRESS> Cc:	"Frey, Nathan J."<EMAIL_ADDRESS>Peter Tsirigotis/RTP/USEPA/US@EPA, RobertJ Wayland/RTP/USEPA/US@EPA, Joseph Goffman/DC/USEPA/US@EPA

Date:	03/22/2012 12:04 AM

Subject:	Revised GHG NSPS preamble

Dom,

The attached version of the preamble responds to the comments your staff provided on transitional units as well as a few other fixes.   We also fixed a few inconsistencies in chapter 5 of the RIA

- Kevin

EGU NSPS preamble 3-21.docx

RIA chap 5.docx


[Federal Register Volume 83, Number 76 (Thursday, April 19, 2018)]
[Rules and Regulations]
[Pages 17295-17299]
[FR Doc No: 2018-08230]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-0016]
RIN 1625-AA87

Security Zone; Presidential Security Zone, Palm Beach, FL

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is establishing a security zone that
encompasses certain waters of the Lake Worth Lagoon, Intracoastal
Waterway, and Atlantic Ocean near the Mar-A-Lago Club and the Southern
Boulevard Bridge in Palm Beach, Florida (FL). The Coast Guard will only
enforce this rule when the President of the United States, members of
the First Family, or other persons under the protection of the Secret
Service are present or expected to be present. This action is necessary
to protect the official party, public, and surrounding waterways from
terrorist acts, sabotage or other subversive acts, accidents, or other
events of a similar nature.

DATES: This rule is effective May 21, 2018.

ADDRESSES: To view documents mentioned in this preamble go to: http://www.regulations.gov and enter USCG-2017-0016 in the ``SEARCH'' feature.
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, Petty Officer Mara Brown, Waterways Management Division,
U.S. Coast Guard; telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    Through this final rule, the United States Coast Guard is
establishing a security zone that encompasses certain waters of the
Lake Worth Lagoon, the Intracoastal Waterway, and the Atlantic Ocean in
the vicinity of the Mar-a-Lago Club and the Southern Boulevard Bridge
in Palm Beach, FL. The security zone is necessary to protect the
official party, the public, and the surrounding waterway from terrorist
acts, sabotage or other subversive acts, accidents, or other events of
a similar nature. The Coast Guard will only enforce the security zone
when the President of the United States, members of the First Family,
or other persons under the protection of the Secret Service are present
or expected to be present. On June 20, 2017, the Coast Guard published
a notice of proposed rulemaking (NPRM) entitled, ``Security Zone;
Presidential Security Zone, Palm Beach, FL'' in the Federal Register
(82 FR 28036). In the NPRM, we invited members of the public to provide
comments on our proposed regulatory action related to this security
zone. During the comment period, which ended on July 20, 2017, the
Coast Guard received sixteen submissions containing twenty-two separate
comments.

III. Legal Authority and Need for the Rule

    The Coast Guard is issuing this rule under the authority in 33
U.S.C. 1231. The COTP Miami has determined the security zone is
necessary to protect the official party, public, and surrounding
waterways from terrorist acts, sabotage or other subversive acts,
accidents, or other events of a similar nature. The purpose of this
rule is to ensure the security of vessels and navigable waters during
visits to the Mar-a-Lago Club by the President, the First Family, and
other persons under the protection of the Secret Service.

IV. Discussion of Comments and Changes to the Rule

A. Discussion of Comments

    The Coast Guard received sixteen submissions from the public
consisting of twenty-two separate comments in response to the proposed
rule. The total number of comments exceeds the number of submissions
because many commenters expressed their views about more than one
aspect of the proposed rule. All the comments we received were from
private citizens and are discussed below.
    Six commenters endorsed the Coast Guard's proposal, but some of
these commenters had questions or concerns that we will discuss
individually below.
    Three commenters expressed opposition to the proposed rule. One of
these commenters expressed opposition to any waterway restrictions. We
note this opposition. The two other commenters expressed concern that
the restrictions on boaters would be

permanently enforced year round. As noted in the NPRM, the security
zone will not be in effect at all times. The Coast Guard will only
enforce the security zone when the President, First Family, or persons
receiving Secret Service protection are present or expected to be
present at the Mar-a-Lago Club.
    Three commenters had regulatory-related questions. Two questions
were of a similar nature, involving public notification. One of these
commenters suggested the Coast Guard notify each affected property
owner prior to activating the security zone. The other commenter asked
if signs advising the public of the security zone would be placed on a
nearby bridge and surrounding area. The Coast Guard considered these
comments and will amend the final rule's regulatory text in section
165.785(d) to advise the public that it will rely on our notification
methods described in 33 CFR 165.7 to notify the local community prior
to activating the security zone.\1\ The Coast Guard will send a
Maritime Safety Information Bulletin (MSIB) that contains a map of the
security zone and description of the regulation to a local marine
industry group who will circulate the MSIB among local marinas and
local boating clubs. In addition, on-scene Coast Guard units will
distribute MSIBs to approaching boaters. The Coast Guard will also
issue a press release to local news outlets, and post the information
on social media and on its news website at: www.news.uscg.mil. On-scene
Coast Guard patrol assets will also display flashing energized blue
lights when the center, west, or east security zones are in effect.
Finally, the Coast Guard will issue a Broadcast Notice to Mariners
(BNM) over VHF marine radio on channel 16. The third commenter asked if
first-time violators of the security zone could receive a reduced fine.
Any violation of the security zone may result in fines and/or penalties
as set forth in 33 U.S.C. 1232 and 50 U.S.C. 192; however, law
enforcement units enforcing the security zone will determine whether a
citation or warning is warranted on a case-by-case basis.
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    \1\ 33 CFR 165.7(a) permits the Coast Guard to notify persons of
the establishment of limited access areas and regulated navigation
areas by ``marine broadcasts, local notice to mariners, local news
media, distribution in leaflet form, and on-scene oral notice, as
well as publication in the Federal Register.''
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    Four submissions were related to the restrictions being placed on
boater activities, including non-motorized boats such as kayaks,
canoes, and paddleboards. These comments ranged from concerns the
security zone would affect the pleasure of boating to concerns that
residents would not be allowed to use their boats at all. They also
expressed concerns that they would not be able to return to their
waterfront homes when the security zone was activated. The east or west
security zones do not prohibit boaters from travelling through these
zones; they merely regulate how boaters may transit through these
areas. The west zone requires persons and vessels seeking to travel
through this zone to be escorted by an on-scene designated
representative, maintain a steady speed, and not slow down or stop
except in the case of unforeseen mechanical failure or other emergency.
The east zone does not require an escort, but requires persons and
vessels seeking to travel through this zone to travel at a steady
speed, and not slow down or stop except in the case of unforeseen
mechanical failure or other emergency. The center zone is the only zone
that prohibits any vessel or person from entering, transiting,
anchoring in, or remaining within the zone without obtaining permission
from the COTP Miami or a designated representative, while the security
zone is in effect. Boaters wishing to return home through the center
zone when this zone is in effect will have to notify on-scene law
enforcement units who will then escort them back to their dock.
    In addition, the commenters advocated for allowing non-motorized
boats to come within 50 feet of the Mar-a-Lago Club, which is adjacent
to the center zone. As stated above, boats are prohibited from
entering, transiting, anchoring in, or remaining in the center zone
without obtaining permission from the COTP Miami or a designated
representative. Allowing pleasure boats to enter this zone for
recreational purposes while the security zone is in effect would reduce
the effectiveness of this zone as a protective measure.
    One commenter expressed concerns that the rule would affect
businesses in the area, which heavily rely on tourist dollars,
especially during the peak autumn months. The commenter added one of
the primary attractions to Florida is the boating and fishing
industries and the creation of the security zone would discourage
tourists from visiting the area, and as a result, local businesses
would lose revenue. We believe businesses that rely on tourism will not
be affected by this rule because these businesses will be allowed to
continue to conduct their business practices as they normally would
even when the security zone is in effect.
    Another commenter sought clarification on why the proposed rule
would not adversely affect the economy, and why making this a permanent
rule that would be enforced using government resources is required or
provides a cost benefit to the public in lieu of the ``temporary
security zones'' referenced in the NPRM at Section II, ``Background,
Purpose, and Legal Basis.'' The rule will not have an adverse effect on
the economy because this rule will not have an annual effect on the
economy of $100 million or more or adversely affect in a material way
the economy, a sector of the economy, productivity, competition, jobs,
the environment, public health or safety, or State, local, or tribal
governments or communities. For further information on the economic
analysis of this rule, see sections V.A. and V.B. of this final rule
below. The security zone established by this rule would not be in
effect all the time, but only during visits by the President, the First
Family, and other persons under the protection of the Secret Service to
the Mar-a-Lago Club. The Coast Guard conducted a cost-benefit analysis
of this regulatory action, and determined creating a permanent security
zone was the best approach to achieve our regulatory objectives because
of the recurring need for the zone for an extended period of time.
Establishing a permanent security zone allows the public and
potentially affected persons to establish certainty about expected
protection measures during such visits.
    One comment addressed concerns with the public's ability to protest
from their boats. The Coast Guard respects the First Amendment rights
of protesters. Any persons wishing to protest in a location affected by
this rule should contact the person listed in the FOR FURTHER
INFORMATION CONTACT section so they may coordinate protest activities
in a manner that would not jeopardize the safety or security of people,
places, or vessels.
    Another commenter stated the way in which armed on-scene Coast
Guard personnel speed toward boaters is unnecessary and intimidating.
The commenter added that approaching boaters in this manner tends to
make the boater stop, but the proposed rule states that boaters should
not stop or they will be considered a threat. The purpose of the
security zone is to protect the official party, the public, and the
surrounding waterway from terroristic acts, sabotage or other
subversive acts, accidents, or other events of a similar nature. As
such, the Coast Guard must adhere to certain protocols in the course of
enforcing the security zone. On-scene Coast Guard units are following
established protocols that include

having armed personnel who will approach and investigate all vessels
seeking escort through the security zone to ensure the safety of all
persons involved.
    One commenter requested the Coast Guard establish a safety zone, in
addition to a security zone, in the waters around the Mar-a-Lago Club,
and suggested this could easily be done by placing floating buoys in
the safety zone area advising boaters that the area is inaccessible.
The commenter is concerned that dredging would occur around the Mar-a-
Lago Club, which would allow boaters to anchor their vessels unattended
within the area covered by the security zone, and then when the
security zone goes into effect there would be no place to put these
vessels. The waters around the Mar-a-Lago Club are not deep enough for
boaters to anchor their vessels nor has there been an issue with
boaters attempting to anchor their vessels in the waters around the
Mar-a-Lago Club. The Coast Guard has determined a security zone is
sufficient to mitigate any potential security threats presented while
protected persons are in the residence at the Mar-a-Lago Club.
    We received one comment suggesting that the Coast Guard's
protection of the waters near the Mar-A-Lago Club should be tied to the
Coast Guard's budget. This comment is beyond the scope of this
rulemaking.

B. Discussion of Changes

    This rule contains changes in the regulatory text from the NPRM. We
found the coordinates defining the east security zone (section
165.785(a)(3)) to be incorrect. The incorrect coordinates extended the
east security zone further offshore than intended. The regulatory text
in this rule contains the corrected coordinates. The revised
coordinates for the east zone are: All waters of the Atlantic Ocean
within the following points: Beginning at Point 1 in position
26[deg]41'21'' N, 80[deg]02'01'' W; thence south following the
shoreline to Point 2 in position 26[deg]39'57'' N, 80[deg]2'09'' W;
thence east to Point 3 in position 26[deg]39'57'' N, 80[deg]01'36'' W;
thence north to Point 4 in position 26[deg]41'22'' N, 80[deg]01'29'' W,
thence back to the origin at Point 1.
    In 33 CFR 165.785(a)(1)-(a)(3), the words ``surface to bottom'' are
added to clarify the extent of the intended coverage of the security
zone.
    In response to public comments we have revised the regulatory text
in section 165.785(d) to provide for additional public outreach
information not listed in the NPRM. The Coast Guard will notify the
local community of the security zone in several ways consistent with
our notification regulations contained in 33 CFR 165.7. Prior to
activating the security zone, the Coast Guard will send a MSIB that
contains a map of the security zone and description of the regulation
to a local marine industry group who will circulate the MSIB among
local marinas and local boating clubs. In addition, on-scene Coast
Guard units will distribute MSIBs to approaching boaters. The Coast
Guard will also issue a press release to local news outlets, and post
the information on social media and on its news website at:
www.news.uscg.mil. On-scene Coast Guard patrol assets will display
flashing energized blue lights when the center, west, or east security
zones are in effect.

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 the First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review) 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 (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Executive Order 13771 (Reducing Regulation and Controlling Regulatory
Costs) directs agencies to reduce regulation and control regulatory
costs and provides that ``for every one new regulation issued, at least
two prior regulations be identified for elimination, and that the cost
of planned regulations be prudently managed and controlled through a
budgeting process.''
    The Office of Management and Budget (OMB) has not designated this
rule a significant regulatory action under section 3(f) of Executive
Order 12866. Accordingly, OMB has not reviewed it. As this rule is not
a significant regulatory action, this rule is exempt from the
requirements of Executive Order 13771. See the OMB Memorandum titled
``Guidance Implementing Executive Order 13771, `Reducing Regulation and
Controlling Regulatory Costs''' (April 5, 2017).
    The economic impact of this rule is not significant for the
following reasons: (1) The security zone will only be enforced when the
President of the United States, members of the First Family, or other
persons under the protection of the Secret Service are present or
expected to be present; (2) The center zone will only affect a
relatively small area of the Intracoastal Waterway in Palm Beach, FL
and vessels will be able to transit the zone if granted permission to
do so by the COTP Miami or a designated representative; (3) The west
zone is located in an area of the Intracoastal Waterway where vessel
traffic is low, approximately 152 vessels per day, and vessels will be
allowed to transit the zone when escorted by an on-scene designated
representative; (4) Vessels may transit the east zone at a steady speed
as long as they do not slow down or stop except in case of unforeseen
mechanical failure or other emergency; and (5) The Coast Guard will
notify the local community of the security zone in several ways
consistent with our notification regulations contained in 33 CFR 165.7.
Prior to activating the security zone, the Coast Guard will send a
Maritime Safety Information Bulletin (MSIB) that contains a map of the
security zone and description of the regulation to a local marine
industry group who will circulate the MSIB among local marinas and
local boating clubs. In addition, on-scene Coast Guard units will
distribute MSIBs to approaching boaters. The Coast Guard will also
issue a press release to local news outlets, and post the information
on social media and on its news website at: www.news.uscg.mil. On-scene
Coast Guard patrol assets will display flashing energized blue lights
when the center, west, or east security zones are in effect. Larger
vessels may need to wait to pass under the Southern Boulevard Bridge,
which has set opening times pursuant to a separate existing regulation
at 33 CFR 117.261(w). The bridge opens on the quarter-hour and three-
quarter hour, or as directed by the on-scene designated representative.

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. 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, which guides the Coast Guard in complying with the
National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and
have determined that this action is one of a category of actions that
do not individually or cumulatively have a significant effect on the
human environment. This rule involves a security zone lasting only a
few days at a time that will restrict entry within certain waters of
the Intracoastal Waterway and the Atlantic Ocean in Palm Beach, FL. 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,
and under paragraph 34(g) of Figure 2-1 of Commandant Instruction
M16475.lD. 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. Add Sec.  165.785 before the undesignated center heading ``Eighth
Coast Guard District'' to read as follows:

Sec.  165.785  Security Zone; Presidential Security Zone, Palm Beach,
FL.

    (a) Regulated areas. The following areas are security zones:
    (1) Center zone. All waters of Lake Worth Lagoon from surface to
bottom within the following points: Beginning at Point 1 in position
26[deg]41'21'' N, 80[deg]02'39'' W; thence east to Point 2 in position
26[deg]41'21'' N, 80[deg]02'13'' W; thence south following the
shoreline to Point 3 in position 26[deg]39'58'' N, 80[deg]02'20'' W;
thence west to Point 4 in position 26[deg]39'58'' N, 80[deg]02'38'' W,
thence back to origin at Point 1.
    (2) West zone. All waters of Lake Worth Lagoon from surface to
bottom within the following points: Beginning at Point 1 in position
26[deg]41'21'' N, 80[deg]02'39'' W; thence west to Point 2 in position
26[deg]41'21'' N, 80[deg]03'00'' W; thence south following the
shoreline to Point 3 in position 26[deg]39'58'' N, 80[deg]02'55'' W;
thence east to Point 4 in position 26[deg]39'58'' N, 80[deg]02'38'' W,
thence back to origin at Point 1.
    (3) East zone. All waters of the Atlantic Ocean from surface to
bottom within the following points: Beginning at Point 1 in position
26[deg]41'21'' N, 80[deg]02'01'' W; thence south following the
shoreline to Point 2 in position 26[deg]39'57'' N, 80[deg]2'09''W;
thence east to Point 3 in position 26[deg]39'57'' N, 80[deg]01'36'' W;
thence north to Point 4 in position 26[deg]41'22'' N, 80[deg]01'29'' W,
thence back to origin at Point 1.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, as well as
Federal, state, and local officers designated by or assisting the COTP
Miami with enforcing the security zone.
    (c) Regulations--(1) Center zone. All persons and vessels are
prohibited from entering, transiting, anchoring in, or remaining within
the security zone

unless authorized by the COTP Miami or a designated representative.
    (2) West zone. All persons and vessels are required to transit the
security zone escorted by an on-scene designated representative at a
steady speed and may not slow down or stop except in the case of
unforeseen mechanical failure or other emergency. Any persons or
vessels forced to slow or stop in the zone shall immediately notify the
COTP Miami via VHF channel 16.
    (3) East zone. All persons and vessels are required to transit the
security zone at a steady speed and may not slow down or stop except in
the case of unforeseen mechanical failure or other emergency. Any
persons or vessels forced to slow or stop in the zone shall immediately
notify the COTP Miami via VHF channel 16.
    (4) Contacting Captain of the Port. Persons who must notify or
request authorization from the COTP Miami may do so by telephone at
(305)535-4472 or may contact a designated representative via VHF radio
on channel 16. If authorization to enter, transit through, anchor in,
or remain within the security zone is granted by the COTP Miami or a
designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the COTP Miami or
the designated representative.
    (d) Enforcement period. This section will be enforced when the
President of the United States, members of the First Family, or other
persons under the protection of the Secret Service are present or
expected to be present at the Mar-a-Lago Club in Palm Beach, Florida.
The Coast Guard will rely on the methods described in Sec.  165.7 to
notify the public prior to activation of any of the security zones
described in paragraph (a) of this section. Coast Guard patrol assets
will also be on-scene with flashing energized blue lights when the
center, west, or east security zone is in effect.

    Dated: April 7, 2018.
M.M. Dean,
Captain, U.S. Coast Guard, Captain of the Port Miami.
[FR Doc. 2018-08230 Filed 4-18-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 223 (Wednesday, November 18, 2020)]
[Notices]
[Pages 73483-73485]
[FR Doc No: 2020-25411]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1429]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Registration of Human
Drug Compounding Outsourcing Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act and Associated Fees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by December 18, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0776. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Registration of Human Drug Compounding Outsourcing Facilities Under
Section 503B of the Federal Food, Drug, and Cosmetic Act and Associated
Fees

OMB Control Number 0910-0776--Revision

    This information collection helps to support implementation of
section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and
the Drug Quality and Security Act (DQSA).
A. Registration
    Under section 503B of the FD&C Act (21 U.S.C. 353b), added by DQSA,
a facility that compounds drugs may elect to register with FDA as an
outsourcing facility. Drug products compounded in a registered
outsourcing facility can qualify for exemptions from the FDA-approval
requirements in section 505 of the FD&C Act (21 U.S.C. 355), the
requirement to label products with adequate directions for use under
section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)), and the
requirements for drug supply chain security in section 582 of the FD&C
Act (21 U.S.C. 360eee-1) if the requirements in section 503B of the
FD&C Act have been met.
    After the initial registration, under section 503B(b) of the FD&C
Act, a facility that elects to register with FDA as an outsourcing
facility must also do so annually between October 1 and

December 31. Upon registration, the outsourcing facility must provide
specific information including its name, place of business, a unique
facility identifier, and a point of contact's email address and phone
number. The outsourcing facility must also indicate: (1) Whether it
intends to compound, within the next calendar year, a drug that appears
on our drug shortage list in effect under section 506E of the FD&C Act
(21 U.S.C. 356e); and (2) whether it compounds from bulk drug
substances and, if so, whether it compounds sterile or non-sterile
drugs from bulk drug substances.
    Outsourcing facilities that elect to register submit registration
information for each facility electronically using a Structured Product
Labeling (SPL) format in accordance with the FDA guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--Drug
Establishment Registration and Drug Listing (May 2009).'' The guidance
is available from our website at: https://www.fda.gov/media/71146/download. Respondents unable to use electronic means to register may
submit a written request for a waiver from the requirement.
B. Registration Fees
    Upon registration, and in accordance with section 503B and 744K of
the FD&C Act, facilities are assessed an establishment fee and receive
an annual invoice from FDA with instructions for remitting payment.
Until payment is made for each given fiscal year (FY), an establishment
is not considered to be registered as an outsourcing facility.
    In accordance with section 744K of the FD&C Act (21 U.S.C. 379j-
62), certain outsourcing facilities may qualify for a small business
reduction in the amount of the annual establishment fee. To qualify for
this reduction, an outsourcing facility must submit a written request
to FDA certifying that the entity meets the requirements for the
reduction. For each FY a firm seeks to qualify as a small business and
receive the fee reduction, it must submit to FDA a written request by
April 30 of the preceding FY. For example, an outsourcing facility must
have submitted a written request for the small business reduction by
April 30, 2020, to qualify for a reduction in the fiscal year 2021
annual establishment fee.
    Section 744K also requires an outsourcing facility to submit
written requests for a small business reduction in a specified format:
Form FDA 3908 entitled ``Outsourcing Facilities for Human Drug
Compounding: Small Business Establishment Fee Reduction Request.'' Form
FDA 3908 is available from our website at: https://www.fda.gov/media/90740/download. In response to the submission of a small business
reduction request, FDA will send a notification letter of its decision
and recommends that applicants retain the notification.
C. Reinspection Fees
    In accordance with section 503B of the FD&C Act, outsourcing
facilities are subject to inspection and, in accordance with section
744K, subject to reinspection fees. A reinspection fee will be incurred
for each reinspection and is intended to reimburse FDA when a
particular outsourcing facility requires reinspection because of
noncompliance identified during a previous inspection. After a
reinspection is conducted, FDA will send an invoice to the email
address indicated in the facility's registration file. The invoice
contains instructions for remitting the reinspection fee.
D. Dispute Resolution
    Agency regulations under Sec.  10.75 (21 CFR 10.75) provide for
internal Agency review of decisions. Accordingly, an outsourcing
facility may request reconsideration of an FDA decision related to the
fee provisions of section 744K of the FD&C Act. Requests for
reconsideration should include the facility's rationale for its
position that FDA's decision was in error and include any additional
information that is relevant to the outsourcing facility's assertion.
The denial of a request for reconsideration may be appealed by
submitting a written request to FDA, consistent with Sec.  10.75.
    To assist respondents with the information collection provisions,
we have developed Agency guidance. The guidance document entitled
``Registration of Human Drug Compounding Outsourcing Facilities Under
Section 503B of the FD&C Act (November 2014)'' describes the process
for electronic submission of establishment registration information for
outsourcing facilities and provides information on how to obtain a
waiver from submitting registration information electronically. The
guidance document entitled ``Fees for Human Drug Compounding
Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act
(November 2014)'' describes the types and amounts of fees that
outsourcing facilities must pay, the adjustments to fees required by
law, how outsourcing facilities can submit payment to FDA, the
consequences of outsourcing facilities' failure to pay fees, and how an
outsourcing facility can qualify as a small business to obtain a
reduction in fees. The guidance documents were issued consistent with
our good guidance practice regulations (21 CFR 10.115), which provide
for public comment at any time, and are available on our website at
https://www.fda.gov/media/87570/download and https://www.fda.gov/media/136683/download, respectively.
    In the Federal Register of August 20, 2020 (85 FR 51442), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electronic Submission of Registration                      70               1              70  4.5......................................             315
 Information Using the SPL Format.
Waiver Request From Electronic Submission of                1               1               1  1........................................               1
 Registration Information.
                                              ----------------------------------------------------------------------------------------------------------
    Subtotal.................................
Remission of Annual Establishment Fee From                 70               1              70  0.5 (30 minutes).........................              35
 FDA Invoice.
Request for Small Business Reduction (Form                 15               1              15  25.......................................             375
 FDA 3908).
Reinspection Fees............................              14               1              14  0.5 (30 minutes).........................               7

Reconsideration Requests.....................               3               1               1  1........................................               3
Appeal of Reconsideration Denials............               1               1               1  1........................................               1
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............             101  .........................................             421
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We estimate 70 respondents annually will submit outsourcing
facility registrations using the SPL format as specified in Agency
guidance and assume each registration will require 4.5 hours to prepare
and complete. We expect no more than one waiver request from the
electronic submission requirement annually and assume each waiver
request will require 1 hour to prepare and submit. We estimate each of
the 70 registrants will remit annual establishment fees and assume this
task requires 30 minutes per respondent. We estimate that 15 of those
respondents will request a small business reduction in the amount of
the annual establishment fee using Form FDA 3908.
    We estimate 14 outsourcing facilities annually will remit
reinspection fees and assume this will require 30 minutes. We also
estimate that we will receive three requests for reconsideration and
one appeal of a denial of a request for reconsideration and assume 1
hour per respondent for this activity.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                      Number of       records per      Total annual       Average burden per recordkeeping       Total hours
                                              recordkeepers     recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Retention of small business designation                  15                1               15   0.5 (30 minutes).......................             7.5
 notification letter.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We estimate that annually 15 outsourcing facilities will maintain a
copy of their small business designation letter and that maintaining
each record will require 0.5 hour (30 minutes).
    These estimates reflect a slight increase in the number of annual
registrations, but a decrease in reinspection fee submissions.

    Dated: November 12, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25411 Filed 11-17-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Rules and Regulations]
[Page 69136]
[FR Doc No: 2011-28888]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 372

[EPA-HQ-TRI-2009-0844; FRL-9488-5]
RIN 2025-AA27

Hydrogen Sulfide; Community Right-to-Know Toxic Chemical Release
Reporting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Lifting of Administrative Stay for Hydrogen Sulfide;
Correction.

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

SUMMARY: The Environmental Protection Agency published in the Federal
Register of October 17, 2011, a document lifting the Administrative
Stay of the reporting requirements for hydrogen sulfide. The Office of
the Federal Register mistakenly lifted the stay of the reporting
requirements for methyl mercaptan, and the document also inadvertently
left out language in the preamble and contained incorrect language in
the amendatory instruction section, which section is required by 1 CFR
21.1. This document affirms that the stay on the reporting requirements
for methyl mercaptan was not lifted and sets out the language in the
preamble and the amendatory instruction section as it should have
printed.

DATES: Effective on October 17, 2011.

FOR FURTHER INFORMATION CONTACT: Daniel R. Bushman, Environmental
Analysis Division, Office of Information Analysis and Access (2842T),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 566-0677; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Environmental Protection Agency
published a document on August 22, 1994 (59 FR 43048) imposing stays on
the reporting requirements for hydrogen sulfide and methyl mercaptan
found at 40 CFR 372.65. The document published in the Federal Register
of October 17, 2011 (76 FR 64022) should have lifted the Administrative
Stay of the reporting requirements for only hydrogen sulfide. The
Office of the Federal Register mistakenly lifted the stay of the
reporting requirements for methyl mercaptan as well. The document also
inadvertently left out language in the preamble and contained incorrect
language in the amendatory instruction section, which section is
required by 1 CFR 21.1, regarding the lifted stay of hydrogen sulfide
reporting requirements.
    In FR Doc. 2011-23534 published on October 17, 2011 (76 FR 64022),
make the following corrections.
    1. On page 64025, in the second column, add a new paragraph before
the beginning of section IV as follows:
    ``In order to lift the stay, as a procedural matter, EPA must
include an instruction to the Office of the Federal Register, as
required by 1 CFR 21.1. This instruction does not alter or change the
content or text of any regulatory provision.''
    2. On page 64037, in the third column following the signature,
correctly revise the amendatory language to read as follows:
    ``Therefore, 40 CFR part 372 is affected as follows:

PART 372--[RESTATED]

0
1. The authority citation for part 372 continues to read as follows:

    Authority: 42 U.S.C. 11023 and 11048.

Sec.  372.65  [Affected]

0
2. Section 372.65 is affected by lifting the reporting stay on the
hydrogen sulfide entry and all related dates under paragraph (a), and
by lifting the stay on the entry for CAS No. 7783-06-4 and all related
dates under paragraph (b).''

    Dated: November 2, 2011.
Malcolm D. Jackson,
Assistant Administrator and Chief Information Officer.
[FR Doc. 2011-28888 Filed 11-7-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 138 (Thursday, July 22, 2021)]
[Notices]
[Page 38732]
[FR Doc No: 2021-15619]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3561-EM; Docket ID FEMA-2021-0001]

Florida; Amendment No. 1 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of an emergency declaration for
the State of Florida (FEMA-3561-EM), dated July 4, 2021, and related
determinations.

DATES: This amendment was issued July 7, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of an emergency declaration for
the State of Florida is hereby amended to include the following areas
among those areas determined to have been adversely affected by the
event declared an emergency by the President in his declaration of July
4, 2021.

    Alachua, Columbia, Dixie, Franklin, Hamilton, Gilchrist,
Jefferson, Lake, Lafayette, Madison, Marion, Sumter, Suwannee,
Taylor, and Wakulla Counties for emergency protective measures
(Category B), limited to direct Federal assistance and reimbursement
for mass care including evacuation and shelter support.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-15619 Filed 7-21-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 78, Number 115 (Friday, June 14, 2013)]
[Notices]
[Page 35945]
[FR Doc No: 2013-14089]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2013-0226]

Certificate of Alternative Compliance for the M/V MADELINE,
669921

AGENCY: Coast Guard, DHS.

ACTION: Notice.

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

SUMMARY: The Coast Guard announces that a Certificate of Alternative
Compliance was issued for the passenger vessel ferry MADELINE as
required by 33 U.S.C. 1605(c) and 33 CFR 81.18.

DATES: The Certificate of Alternative Compliance was issued on January
28, 2013.

ADDRESSES: The docket for this notice is available for inspection or
copying at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. You may also find this
docket on the Internet by going to http://www.regulations.gov,
inserting USCG-2013-0226 in the ``SEARCH'' box, and then clicking
``Search.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call LT Steven Melvin, District Nine, Prevention Branch, U.S. Coast
Guard, telephone<PHONE_NUMBER>. If you have questions on viewing or
submitting material to the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    A Certificate of Alternative Compliance, as allowed for under 33
U.S.C. 1605(c) and 33 CFR 81.18, has been issued for the M/V MADELINE.
The vessel's primary purpose is as an island passenger car ferry that
operates on the south shore of Lake Superior in Northern Wisconsin. The
unique design of the vessel did not lend itself to full compliance with
Annex I of the Inland Rules Act.
    The Commandant, U.S. Coast Guard, certifies that full compliance
with the Inland Rules Act would interfere with the special functions/
intent of the vessel and would not significantly enhance the safety of
the vessel's operation. Placing the starboard and port side lights in
the required position would make them vulnerable to damage from the
dock wall because of consistent lower than normal water levels on Lake
Superior.
    The Certificate of Alternative Compliance authorizes the M/V
MADELINE to deviate from the requirements set forth in Annex I of the
Inland Rules Act by placing its port and starboard lights on the main
superstructure above the pilot house.
    This notice is issued under authority of 33 U.S.C. 1605(c), and 33
CFR 81.18.

    Dated: May 10, 2013.
S.E. Anderson,
Commander, U.S. Coast Guard Acting Chief, Prevention Division By
Direction of the Commander, Ninth Coast Guard District.
[FR Doc. 2013-14089 Filed 6-13-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 218 (Tuesday, November 14, 2017)]
[Notices]
[Page 52763]
[FR Doc No: 2017-24574]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82025; File No. SR-BatsBZX-2017-54]

Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To List and Trade Shares of the iShares Inflation Hedged
Corporate Bond ETF, a Series of the iShares U.S. ETF Trust, Under Rule
14.11(i), Managed Fund Shares

November 7, 2017.
    On September 7, 2017, Bats BZX Exchange, Inc. (``BZX'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to list and trade shares of the iShares Inflation
Hedged Corporate Bond ETF, a series of the iShares U.S. ETF Trust,
under BZX Rule 14.11(i). The proposed rule change was published for
comment in the Federal Register on September 27, 2017.\3\ The
Commission received no comments on the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 81671 (September 21,
2017), 82 FR 45103.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is November 11, 2017. The Commission is extending this 45-day time
period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change.
Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\5\ designates December 26, 2017, as the date by which the
Commission shall either approve or disapprove or institute proceedings
to determine whether to disapprove the proposed rule change (File
Number SR-BatsBZX-2017-54).
---------------------------------------------------------------------------

    \5\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-24574 Filed 11-13-17; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 239 (Thursday, December 12, 2013)]
[Notices]
[Page 75573]
[FR Doc No: 2013-29655]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2013-0035; OMB No. 1660-0089]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before January 13, 2014.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 1800 South Bell Street, Arlington, VA
20598-3005, facsimile number<PHONE_NUMBER>, or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Collection of Information

    Title: FEMA Mitigation Success Story Database.
    Type of Information Collection: Extension, without change, of a
currently approved information collection.
    OMB Number: 1660-0089.
    Form Titles and Numbers: FEMA Form 086-0-25, Mitigation Best
Practice Submission Worksheet.
    Abstract: FEMA uses the information provided through success
stories to document and disseminate first-hand experiences of
mitigation activities that result in benefits to individuals. By
sharing information, communities, individuals, and the affected public
can learn about available Federal programs to support the
implementation of noteworthy local activities that lessen the chance of
a catastrophic event causing damage or possibly loss of life.
    Affected Public: Individuals or households; State, local or Tribal
Government.
    Estimated Number of Respondents: 50.
    Estimated Total Annual Burden Hours: 88 hours.
    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $2,711.28. There are no annual costs to respondents'
operations and maintenance costs for technical services. There is no
annual start-up or capital costs. The cost to the Federal Government is
$75,190.00.

    Dated: December 4, 2013.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2013-29655 Filed 12-11-13; 8:45 am]
BILLING CODE 9110-11-P


incorporation by reference of ``Environmental Sampling and Detection of
Salmonella in Poultry Houses,'' April 2008, in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. The FDA will request approval to incorporate
by reference any updates to this Web site. The FDA will change the date
of the Web site in this paragraph with each update. You may obtain a
copy from Division of Microbiology (HFS-710), Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740,<PHONE_NUMBER>, or you may examine a copy
at the Center for Food Safety and Applied Nutrition's Library, 5100
Paint Branch Pkwy., College Park, MD,<PHONE_NUMBER>, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal_register/code_of_federal_
regulation/ibr_locations.html.
    (b) Testing of egg samples for SE. Testing to detect SE in egg
samples must be conducted according to Chapter 5 of FDA's
Bacteriological Analytical Manual (BAM), December 2007 Edition, or an
equivalent method in accuracy, precision, and sensitivity in detecting
SE. Chapter 5 of FDA's Bacteriological Analytical Manual, December 2007
Edition, is located at http://www.fda.gov/Food/ScienceResearch/
LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm070149.htm,
current as of June 26, 2009. The method is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The FDA will request
approval to incorporate by reference any updates to this Web site. The
FDA will change the date of the Web site in this paragraph with each
update. You may obtain a copy from Division of Microbiology (HFS-710),
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2364, or you may examine a copy at the Center for Food Safety and
Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD,
301-436-2163, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulation/ibr_locations.html.

Sec.  118.9  Administration of the Salmonella Enteritidis (SE)
prevention plan.

    You must have one or more supervisory personnel, who do not have to
be on-site employees, to be responsible for ensuring compliance with
each farm's SE prevention plan. This person must have successfully
completed training on SE prevention measures for egg production that is
equivalent to that received under a standardized curriculum recognized
by the Food and Drug Administration or must be otherwise qualified
through job experience to administer the SE prevention measures. Job
experience will qualify this person to perform these functions if it
has provided knowledge at least equivalent to that provided through the
standardized curriculum. This person is responsible for:
    (a) Development and implementation of an SE prevention plan that is
appropriate for your specific farm and meets the requirements of Sec.
118.4;
    (b) Reassessing and modifying the SE prevention plan as necessary
to ensure that the requirements in Sec.  118.4 are met; and
    (c) Review of records created under Sec.  118.10. This person does
not need to have performed the monitoring or created the records.

Sec.  118.10  Recordkeeping requirements for the Salmonella Enteritidis
(SE) prevention plan.

    (a) Records: You must maintain the following records documenting
your SE prevention measures:
    (1) A written SE prevention plan required by Sec.  118.4;

    (2) Documentation that pullets were ``SE monitored'' or were raised
under ``SE monitored'' conditions, including environmental testing
records for pullets, as required by Sec.  118.4(a)(2);
    (3) Records documenting compliance with the SE prevention measures,
as follows:
    (i) Biosecurity measures;
    (ii) Rodent and other pest control measures;
    (iii) Cleaning and disinfection procedures performed at
depopulation, when applicable;
    (iv) Refrigeration requirements;
    (v) Environmental and egg sampling procedures, when applicable,
performed under Sec.  118.7;
    (vi) Results of SE testing, when applicable, performed under Sec.
118.8 as required in Sec. Sec.  118.4(a)(2), 118.5, and 118.6;
    (vii) Diversion of eggs, if applicable, as required in Sec.  118.6;
and
    (viii) Eggs at a particular farm being given a treatment as defined
in Sec.  118.3, if you are a producer complying with the requirements
of this section as described in Sec.  118.1(a)(2).
    (4) Records of review and of modifications of the SE prevention
plan and corrective actions taken.
    (b) General requirements for records maintained by shell egg
producers. All records required by Sec.  118.10(a) must include:
    (1) Your name and the location of your farm,
    (2) The date and time of the activity that the record reflects,
    (3) The signature or initials of the person performing the
operation or creating the record. The written SE prevention plan must
be dated and carry the signature(s) (not initials) of the person(s) who
administers the plan as described in Sec.  118.9, and
    (4) Data and information reflecting compliance activities must be
entered on records at the time the activity is performed or observed,
and the records must contain the actual values observed, if applicable.
    (c) Length of time records must be retained. You must retain all
records required by this part at your place of business, unless stored
offsite under Sec.  118.10(d), for 1 year after the flock to which they
pertain has been taken permanently out of production.
    (d) Offsite storage of records. You may store the records required
by this part, except for the written SE prevention plan, offsite. You
must be able to retrieve and provide the records at your place of
business within 24 hours of request for official review. Electronic
records are considered to be onsite if they are accessible from an
onsite location.
    (e) Official review of records. You must have all records required
by this part available for official review and copying at reasonable
times.
    (f) Public disclosure of records. Records required by this part are
subject to the disclosure requirements under part 20 of this chapter.

Sec.  118.11  Registration requirements for shell egg producers covered
by the requirements of this part.

    (a) Shell egg producers covered under Sec.  118.1(a) of this part
are required to register their farms with the FDA within 30 days of
becoming an egg producer or, if already an egg producer, by the
applicable effective date of this regulation.
    (b) Shell egg producers may register their farms by any of the
following means:
    (1) Electronic registration. To register electronically, you must
register at http://www.access.fda.gov, which will be available for
registration 24 hours a day, 7 days a week beginning May 10, 2010. This
Web site is available from wherever the Internet is accessible,
including libraries, copy centers, schools, and Internet cafes.
    (i) An individual authorized by the owner or operator of a farm,
such as an agent in charge, may also register a farm electronically.
    (ii) FDA strongly encourages electronic registration for the
benefit of both FDA and the registrant.
    (iii) Once you complete your electronic registration, FDA will
automatically provide you with an electronic confirmation of
registration and a permanent registration number.
    (iv) You will be considered registered once FDA electronically
transmits your confirmation and registration number.
    (2) Registration by mail or by fax. If, for example, you do not
have reasonable access to the Internet through any of the methods
described in paragraph (b)(1) of this section, an individual authorized
by the owner or operator of a farm, such as an agent in charge, may
register by mail or fax.
    (i) You must register using FDA Form No. 3733. You may obtain a
copy of this form by writing to the U.S. Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993, or by requesting the
form by phone at 1-888-INFO-FDA (1-888-463-6332).
    (ii) When you receive the form, you must fill it out completely and
legibly and either mail it to the address in paragraph (b)(2)(i) of
this section or fax it to the number on the form.
    (iii) If any required information on the form is incomplete or
illegible when FDA receives it, FDA will return the form to you for
revision, provided that your mailing address or fax number is legible
and valid. When returning a registration form for revision, FDA will
use the means by which the form was received by the agency (i.e., by
mail or fax).
    (iv) FDA will enter complete and legible mailed and faxed
registration submissions into its registration system, along with CD-
ROM submissions, as soon as practicable, in the order FDA receives
them.
    (v) FDA will then mail to the address or fax to the fax number on
the registration form a copy of the registration as entered,
confirmation of registration, and your registration number. When
responding to a registration submission, FDA will use the means by
which the registration was received by the agency (i.e., by mail or
fax).
    (vi) If any information you previously submitted was incorrect at
the time of submission, you must immediately update your facility's
registration. If any information you previously submitted that was
correct at the time of submission subsequently changes, you must update
your facility's registration within 60 calendar days.
    (vii) Your facility is considered registered once FDA enters your
facility's registration data into the registration system and the
system generates a registration number.
    (3) Registration by CD-ROM for multiple submissions. If, for
example, you do not have reasonable access to the Internet through any
of the methods provided under paragraph (b)(1) of this section, you may
register by CD-ROM.
    (i) Registrants submitting their registrations in CD-ROM format
must use ISO 9660 (CD-R or CD-RW) data format.
    (ii) These files must be submitted on a portable document format
(PDF) rendition of the registration form (FDA Form No. 3733) and be
accompanied by one signed copy of the certification statement that
appears on the registration form.
    (iii) Each submission on the CD-ROM must contain the same preferred
mailing address in the appropriate block on FDA Form No. 3733.
    (iv) A CD-ROM may contain registrations for as many facilities as
needed up to the CD-ROM's capacity.
    (v) The registration on the CD-ROM for each separate facility must
have a unique file name up to 32 characters long, the first part of
which may be used to identify the parent company.
    (vi) You must mail the CD-ROM to the U.S. Food and Drug
Administration,

10903 New Hampshire Avenue, Silver Spring, MD 20993.
    (vii) If FDA receives a CD-ROM that does not comply with these
specifications, it will return the CD-ROM to the submitter unprocessed.
    (viii) FDA will enter CD-ROM submissions that comply with these
specifications into its registration system, along with the complete
and legible mailed and faxed submissions, as soon as practicable, in
the order FDA receives them.
    (ix) For each facility on the CD-ROM, FDA will mail to the
preferred mailing address a copy of the registration(s) as entered,
confirmation of registration, and each facility's assigned registration
number.
    (x) If any information you previously submitted was incorrect at
the time of submission, you must immediately update your facility's
registration. If any information you previously submitted that was
correct at the time of submission subsequently changes, you must update
your facility's registration within 60 calendar days.
    (xi) Your facility is considered registered once FDA enters your
facility's registration data into the registration system and the
system generates a registration number.
    (c) No registration fee is required.
    (d) You must submit all registration information in the English
language. All information must be submitted using the Latin (Roman)
alphabet.
    (e) Each registrant must submit the following information through
one of the methods described in paragraph (b) of this section:
    (1) The name, full address, and phone number of the farm; and
    (2) The average or usual number of layers of each house and number
of poultry houses on the farm.
    (3) A statement in which the shell egg producer certifies that the
information submitted is true and accurate. If the individual
submitting the form is not the shell egg producer in charge of the
farm, the registration must also include a statement in which the
individual certifies that the information submitted is true and
accurate, certifies that he/she is authorized to submit registration,
and identifies by name, address, and telephone number, the individual
who authorized submission of the registration. Each registration must
include the name of the individual registering the farm submitting the
registration, and the individual's signature (for paper and CD-ROM
options).
    (f) Registered egg producers must submit an update to a
registration within 60-calendar days of any change to any of the
information previously submitted by any of the means as provided in
Sec.  118.11(b).
    (g) Registered egg producers must notify FDA within 120 days of
ceasing egg production by completing sections 1b, 1c, and 2 of Form
3733. This notification is not required if you are a seasonal egg
producer or you temporarily cease operation due to labor disputes,
fire, natural disasters, or other temporary conditions.

Sec.  118.12  Enforcement and compliance.

    (a) Authority. This part is established under authority of the
Public Health Service Act (the PHS Act). Under the FFDCA, the Food and
Drug Administration (FDA) can enforce the food adulteration provisions
under 21 U.S.C. 331 through 334 and 342. Under the PHS Act (42 U.S.C.
264), FDA has the authority to make and enforce regulations for the
control of communicable diseases. FDA has established the following
administrative enforcement procedures for the diversion or destruction
of shell eggs and for informal hearings under the PHS Act:
    (1) Upon a finding that any shell eggs have been produced or held
in violation of this part, an authorized FDA representative or a State
or local representative in accordance with paragraph (c) of this
section may order such eggs to be diverted, under the supervision of
said representative, for processing in accordance with the Egg Products
Inspection Act (EPIA) (21 U.S.C. 1031 et seq.) or by a treatment that
achieves at least a 5-log destruction of SE or destroyed by or under
the supervision of an officer or employee of FDA, or, if applicable, of
the State or locality in accordance with the following procedures:
    (i) Order for diversion or destruction under the PHS Act. Any
district office of FDA or any State or locality acting under paragraph
(c) of this section, upon finding shell eggs that have been produced or
held in violation of this regulation, may serve a written order upon
the person in whose possession the eggs are found requiring that the
eggs be diverted, under the supervision of an officer or employee of
the issuing entity, for processing in accordance with the EPIA (21
U.S.C. 1031 et seq.) or by a treatment that achieves at least a 5-log
destruction of SE or destroyed by or under the supervision of the
issuing entity, within 10-working days from the date of receipt of the
order, unless, under paragraph (a)(2)(iii) of this section, a hearing
is held, in which case the eggs must be diverted or destroyed
consistent with the decision of the Regional Food and Drug Director
under paragraph (a)(2)(v) of this section. The order must include the
following information:
    (A) A statement that the shell eggs identified in the order are
subject to diversion for processing in accordance with the EPIA or by a
treatment that achieves at least a 5-log destruction of SE or
destruction;
    (B) A detailed description of the facts that justify the issuance
of the order;
    (C) The location of the eggs;
    (D) A statement that these eggs must not be sold, distributed, or
otherwise disposed of or moved except as provided in paragraph
(a)(1)(iv) of this section;
    (E) Identification or description of the eggs;
    (F) The order number;
    (G) The date of the order;
    (H) The text of this entire section;
    (I) A statement that the order may be appealed by written appeal or
by requesting an informal hearing;
    (J) The name and phone number of the person issuing the order; and
    (K) The location and telephone number of the office or agency
issuing the order and the name of its Director.
    (ii) Approval of District Director. An order, before issuance, must
be approved by FDA's District Director or the Acting District Director.
If prior written approval is not feasible, prior oral approval must be
obtained and confirmed by written memorandum as soon as possible.
    (iii) Labeling or marking of shell eggs under order. An FDA, State,
or local representative issuing an order under paragraph (a)(1)(i) of
this section must label or mark the shell eggs with official tags that
include the following information:
    (A) A statement that the shell eggs are detained in accordance with
regulations issued under section 361(a) of the PHS Act (42 U.S.C.
264(a)).
    (B) A statement that the shell eggs must not be sold, distributed
or otherwise disposed of or moved except, after notifying the issuing
entity in writing, to:
    (1) Divert them for processing in accordance with the EPIA or by a
treatment that achieves at least a 5-log destruction of SE or destroy
them or
    (2) Move them to another location for holding pending appeal.
    (C) A statement that the violation of the order or the removal or
alteration of the tag is punishable by fine or imprisonment or both
(section 368 of the PHS Act (42 U.S.C. 271)).
    (D) The order number and the date of the order, and the name of the
government representative who issued the order.

    (iv) Sale or other disposition of shell eggs under order. After
service of the order, the person in possession of the shell eggs that
are the subject of the order must not sell, distribute, or otherwise
dispose of or move any eggs subject to the order unless and until
receiving a notice that the order is withdrawn after an appeal except,
after notifying FDA's district office or, if applicable, the State or
local representative, in writing, to:
    (A) Divert or destroy them as specified in paragraph (a)(1)(i) of
this section, or
    (B) Move them to another location for holding pending appeal.
    (2) The person on whom the order for diversion or destruction is
served may either comply with the order or appeal the order to the
Regional Food and Drug Director in accordance with the following
procedures:
    (i) Appeal of a detention order. Any appeal must be submitted in
writing to FDA's District Director in whose district the shell eggs are
located within 5-working days of the issuance of the order. If the
appeal includes a request for an informal hearing, the hearing must be
held within 5-working days after the appeal is filed or, if requested
by the appellant, at a later date, which must not be later than 20-
calendar days after the issuance of the order. The order may also be
appealed within the same period of 5-working days by any other person
having an ownership or proprietary interest in such shell eggs. The
appellant of an order must state the ownership or proprietary interest
the appellant has in the shell eggs.
    (ii) Summary decision. A request for a hearing may be denied, in
whole or in part and at any time after a request for a hearing has been
submitted, if the Regional Food and Drug Director or his or her
designee determines that no genuine and substantial issue of fact has
been raised by the material submitted in connection with the hearing or
from matters officially noticed. If the Regional Food and Drug Director
determines that a hearing is not justified, written notice of the
determination will be given to the parties explaining the reason for
denial.
    (iii) Informal hearing. Appearance by any appellant at the hearing
may be by mail or in person, with or without counsel. The informal
hearing must be conducted by the Regional Food and Drug Director or his
designee, and a written summary of the proceedings must be prepared by
the Regional Food and Drug Director.
    (A) The Regional Food and Drug Director may direct that the hearing
be conducted in any suitable manner permitted by law and by this
section. The Regional Food and Drug Director has the power to take such
actions and make such rulings as are necessary or appropriate to
maintain order and to conduct an informal, fair, expeditious, and
impartial hearing, and to enforce the requirements concerning the
conduct of hearings.
    (B) Employees of FDA will first give a full and complete statement
of the action that is the subject of the hearing, together with the
information and reasons supporting it, and may present oral or written
information relevant to the hearing. The party requesting the hearing
may then present oral or written information relevant to the hearing.
All parties may conduct reasonable examination of any person (except
for the presiding officer and counsel for the parties) who makes any
statement on the matter at the hearing.
    (C) The hearing shall be informal in nature, and the rules of
evidence do not apply. No motions or objections relating to the
admissibility of information and views will be made or considered, but
any party may comment upon or rebut any information and views presented
by another party.
    (D) The party requesting the hearing may have the hearing
transcribed, at the party's expense, in which case a copy of the
transcript is to be furnished to FDA. Any transcript of the hearing
will be included with the Regional Food and Drug Director's report of
the hearing.
    (E) The Regional Food and Drug Director must prepare a written
report of the hearing. All written material presented at the hearing
will be attached to the report. Whenever time permits, the Regional
Food and Drug Director may give the parties the opportunity to review
and comment on the report of the hearing.
    (F) The Regional Food and Drug Director must include as part of the
report of the hearing a finding on the credibility of witnesses (other
than expert witnesses) whenever credibility is a material issue, and
must include a recommended decision, with a statement of reasons.
    (iv) Written appeal. If the appellant appeals the detention order
but does not request a hearing, the Regional Food and Drug Director
must render a decision on the appeal affirming or revoking the
detention order within 5-working days after the receipt of the appeal.
    (v) Regional Food and Drug Director decision. If, based on the
evidence presented at the hearing or by the appellant in a written
appeal, the Regional Food and Drug Director finds that the shell eggs
were produced or held in violation of this section, he must affirm the
order that they be diverted, under the supervision of an officer or
employee of FDA for processing under the EPIA or by a treatment that
achieves at least a 5-log destruction of SE or destroyed by or under
the supervision of an officer or employee of FDA; otherwise, the
Regional Food and Drug Director must issue a written notice that the
prior order is withdrawn. If the Regional Food and Drug Director
affirms the order, he must order that the diversion or destruction be
accomplished within 10-working days from the date of the issuance of
his decision. The Regional Food and Drug Director's decision must be
accompanied by a statement of the reasons for the decision. The
decision of the Regional Food and Drug Director constitutes final
agency action, subject to judicial review.
    (vi) No appeal. If there is no appeal of the order and the person
in possession of the shell eggs that are subject to the order fails to
divert or destroy them within 10-working days, or if the demand is
affirmed by the Regional Food and Drug Director after an appeal and the
person in possession of such eggs fails to divert or destroy them
within 10-working days, FDA's district office or, if applicable, the
State or local representative may designate an officer or employee to
divert or destroy such eggs. It shall be unlawful to prevent or to
attempt to prevent such diversion or destruction of the shell eggs by
the designated officer or employee.
    (b) Inspection. Persons engaged in production of shell eggs must
permit authorized representatives of FDA to make, at any reasonable
time, an inspection of the egg production establishment in which shell
eggs are being produced. Such inspection includes the inspection and
sampling of shell eggs and the environment, the equipment related to
production of shell eggs, the equipment in which shell eggs are held,
and examination and copying of any records relating to such equipment
or eggs, as may be necessary in the judgment of such representatives to
determine compliance with the provisions of this section. Inspections
may be made with or without notice and will ordinarily be made during
regular business hours.
    (c) State and local cooperation. Under sections 311 and 361 of the
Public Health Service Act, any State or locality that is willing and
able to assist the agency in the enforcement of Sec. Sec.  118.4
through 118.10, and is authorized to inspect or regulate egg production
establishments, may, in its own jurisdiction, enforce Sec. Sec.  118.4
through

118.10 through inspections under paragraph (b) of this section and
through administrative enforcement remedies specified in paragraph (a)
of this section unless FDA notifies the State or locality in writing
that such assistance is no longer needed. A state or locality may
substitute, where necessary, appropriate State or local officials for
designated FDA officials in this section. When providing assistance
under paragraph (a) of this section, a State or locality may follow the
hearing procedures set out in paragraphs (a)(2)(iii) through (a)(2)(v)
of this section, or may utilize comparable State or local hearing
procedures if such procedures satisfy due process.
    (d) Preemption. No State or local governing entity shall establish,
or continue in effect any law, rule, regulation, or other requirement
regarding prevention of SE in shell eggs during production, storage, or
transportation that is less stringent than those required by this part.

    Dated: July 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16119 Filed 7-7-09; 1:30 pm]

BILLING CODE 4164-01-P