[Federal Register Volume 84, Number 160 (Monday, August 19, 2019)]
[Notices]
[Page 42908]
[FR Doc No: 2019-17723]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RC11-6-009]

North American Electric Reliability Corporation; Notice of Staff
Review of Enforcement Programs

    Commission staff coordinated with the staff of the North American
Electric Reliability Corporation (NERC) to conduct the annual oversight
of the Find, Fix, Track and Report (FFT) program, as outlined in the
March 15, 2012 Order,\1\ and the Compliance Exception (CE) Program, as
proposed by NERC's September 18, 2015 annual Compliance Filing.\2\ The
Commission supported NERC's plan to coordinate with Commission staff to
review the same sample of possible violations, thereby reducing the
burden on the Regional Entities of providing evidence for two different
samples. Furthermore, NERC and Commission staff agreed to exclude the
Florida Reliability Coordinating Council Regional Entity (FRCC) from
the survey, reducing the burden on FRCC as it focuses efforts on a
planned and approved termination of its responsibilities as a Regional
Entity. Commission staff reviewed a sample of 27 FFT possible
violations out of 47 FFT possible violations posted by NERC between
October 2017 and September 2018 and a sample of 37 CE instances of
noncompliance out of 898 CE instances of noncompliance posted by NERC
between October 2017 and September 2018.
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    \1\ North American Electric Reliability Corp., 138 FERC 61,193,
at P 73 (2012) (discussing Commission plans to survey a random
sample of FFTs submitted each year to gather information on how the
FFT program is working).
    \2\ North American Electric Reliability Corp., Docket No. RC11-
6-004, at 1 (Nov. 13, 2015) (delegated letter order) (stating NERC's
intention to combine the evaluation of Compliance Exceptions with
the annual sampling of FFTs to further streamline oversight of the
FFT and compliance exception programs).
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    Commission staff believes that the FFT and CE programs are meeting
expectations, with limited exceptions. Sampling for the 2018 program
year indicated that the Regional Entities appropriately included 63 of
the 64 sampled possible violations in the FFT and CE programs, with
only one exception, and that 62 of the 64 sampled FFTs and CEs have
been adequately remediated, with the remaining two FFTs to be
adequately remediated once the ongoing mitigation is completed in the
coming months. Commission staff's sample analysis indicated a
decreasing number of documentation concerns, particularly with regard
to the clear identification of root cause in the FFT and/or CE
postings. Specifically, the identification of root cause in FFTs and
CEs has improved significantly over the past five years, moving from 38
percent missing an identification of root cause to all now being
included in this year's sampling. Commission staff subsequently
reviewed the supporting information for these FFTs or CEs and agreed
with the final risk determinations for 62 of 64 samples. Commission
staff also noted a significant improvement in the clear identification
of factors affecting the risk prior to mitigation (such as potential
and actual risk), and actual harm, which was identified in all samples.
In addition, Commission staff noted that the FFTs and CEs sampled did
not contain any material misrepresentations by the registered entities.

    Dated: August 12, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-17723 Filed 8-16-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)]
[Proposed Rules]
[Pages 29065-29066]
[FR Doc No: 2018-13377]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-9556; Airspace Docket No. 16-AEA-2]
RIN 2120-AA66

Proposed Establishment and Modification of Area Navigation
Routes, Atlantic Coast Route Project; Northeastern United States

AGENCY: Federal Aviation Administration (FAA) DOT.

ACTION: Notice of proposed rulemaking (NPRM); withdrawal.

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SUMMARY: The FAA is withdrawing the NPRM published in the Federal
Register on January 5, 2017, proposing to establish 12 high altitude
area navigation (RNAV) routes (Q-routes), and modify one existing Q-
route, in support of the Atlantic Coast Route Project (ACRP). The FAA
reviewed project scoping and determined that additional planning is
warranted to ensure a more efficient implementation and integration
with other ongoing program activities, and determined that withdrawal
of the proposed rule is warranted.

DATES: Effective as of 0901 UTC, June 22, 2018, the proposed rule
published January 5, 2017 (82 FR 1276), is withdrawn.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

History

    The FAA published a NPRM in the Federal Register for Docket No.
FAA-2016-9556 (82 FR 1276; January 5, 2017). The NPRM proposed 12 new
Q-routes (Q-75, Q-97, Q-167, Q-220, Q-411, Q-419, Q-430, Q-437, Q-439,
Q-445, Q-450 and Q-479); and existing route Q-480, along the Atlantic
Coast, in the northeastern U.S.
    Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal. No comments were
received.

FAA's Conclusions

    The FAA has reviewed project scoping and determined that additional
planning is warranted to ensure a more efficient implementation and
integration with other ongoing program activities; therefore, the NPRM
is withdrawn.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Withdrawal

0
Accordingly, pursuant to the authority delegated to me, the NPRM
published in the Federal Register on January 5, 2017 (82 FR 1276), FR
Doc. 2016-31911, is hereby withdrawn.

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854; 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

    Issued in Washington, DC, on June 13, 2018.
Scott J. Gardner,
Acting Manager, Airspace Policy Group.
[FR Doc. 2018-13377 Filed 6-21-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 206 (Tuesday, October 25, 2016)]
[Notices]
[Pages 73465-73466]
[FR Doc No: 2016-25755]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0342]

Hours of Service of Drivers: American Concrete Pumping
Association (ACPA); Application for Exemption

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of application for exemption; request for comments.

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SUMMARY: FMCSA announces that it has received an application from the
American Concrete Pumping Association (ACPA) for an exemption from the
30-minute rest break provision of the Agency's hours-of-service (HOS)
regulations for commercial motor vehicle (CMV) drivers. ACPA requests
that concrete pump operators be allowed to use 30 minutes or more of
on-duty ``waiting time'' to satisfy the requirement for the 30-minute
rest break, provided they do not perform any other work during the
break. The requested exemption would apply industry-wide to all
concrete pump operators, concrete pumping companies and drivers who
operate concrete pumps. Due to the nature of pumper operations, ACPA
believes that compliance with the 30-minute rest break rule increases
the risk of dangerous conditions on job sites. ACPA also asserts that
concrete pump operators already take regular rest breaks throughout the
typical day, depending on the work flow at the job site, so an
additional 30-minute rest break does not enhance overall job safety.
FMCSA requests public comment on ACPA's application for exemption.

DATES: Comments must be received on or before November 25, 2016.

ADDRESSES: You may submit comments identified by Federal Docket
Management System Number FMCSA-2016-0342 by any of the following
methods:
     Federal eRulemaking Portal: www.regulations.gov. See the
Public Participation and Request for Comments section below for further
information.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m.
E.T., Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this notice. Note that DOT posts all comments received without
change to www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The on-line FDMS is available 24 hours each
day, 365 days each year.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: For information concerning this
notice, please contact Mr. Tom Yager, Chief, FMCSA Driver and Carrier
Operations Division; Telephone:<PHONE_NUMBER>; Email<EMAIL_ADDRESS>
If you have questions on viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2016-0342), indicate the specific section of this
document to which the comment applies, and provide a reason for
suggestions or recommendations. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so the Agency can contact you if it has questions
regarding your submission.
    To submit your comment online, go to www.regulations.gov and put
the docket number, ``FMCSA-2016-0342'' in the ``Keyword'' box, and
click ``Search.'' When the new screen appears, click on ``Comment
Now!'' button and type your comment into the text box in the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit. If you submit your
comments by mail or hand delivery, submit them in an unbound format, no
larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit comments by mail and would like to know that they
reached the facility, please enclose a stamped, self-addressed postcard
or envelope. FMCSA will consider all comments and material received
during the comment period and may grant or not grant this application
based on your comments.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain Federal Motor Carrier Safety Regulations
(FMCSRs). FMCSA must publish a notice of each exemption request in the
Federal Register (49 CFR 381.315(a)). The Agency must provide the
public an opportunity to inspect the information relevant to the
application, including any safety analyses that have been conducted.
The Agency must also provide an opportunity for public comment on the
request.
    The Agency reviews safety analyses and public comments submitted,
and determines whether granting the exemption would likely achieve a
level of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)) with the reasons for denying or granting the application
and, if granted, the name of the person or class of persons receiving
the exemption, and the regulatory provision from which the exemption is
granted. The notice must also specify the effective period and explain
the terms and conditions of the exemption. The exemption may be renewed
(49 CFR 381.300(b)).

III. Request for Exemption

    On December 27, 2011 (76 FR 81133), FMCSA published a final rule
amending its hours-of-service (HOS) regulations for drivers of
property-carrying CMVs. The final rule adopted several changes to the
HOS regulations, including a provision requiring drivers to take a rest
break during the work day under certain circumstances. Drivers may
drive a CMV only if 8 hours or less have passed since the end of the
driver's last off-duty or sleeper-berth period of at least 30 minutes.
FMCSA did not specify when drivers must take the 30-minute break, but
the rule requires that they wait no longer than 8 hours after the last
off-duty or sleeper-berth period of that length or longer to take the
break if they want to drive a CMV.
    ACPA seeks an exemption from the 30-minute rest break provision in
49 CFR 395.3(a)(3)(ii). The requested exemption would apply industry-
wide to all concrete pump operators, concrete pumping companies and
drivers who deliver, set-up, and operate concrete pumps across the
United States. ACPA currently represents more than 600 member companies
employing over 7,000 workers nationwide. The exemption would be applied
to all interstate concrete pumper trucks and their operators. Although
many of the trucks operate intrastate and would therefore not be
covered by an FMCSA exemption, an unknown number of the pumping trucks
are operated in metropolitan areas and do routinely cross State
lines.\1\
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    \1\ FMCSA does not have jurisdiction over intrastate
transporation; however, most States have commercial motor vehicle
statutes and regulations that are compatible with Federal
regulations. An FMCSA exemption only applies to interstate
transportation, although some States honor them for intrastate
traffic.
---------------------------------------------------------------------------

    ACPA requests the exemption for the following reasons: First, it
argues that the mandatory 30-minute rest break increases the risk of
dangerous conditions on job sites. A mandatory 30-minute rest break
during which the concrete pump operator is considered to be ``off-
duty'' would require the concrete pump to be shut down, and likely
cleaned out. Stopping the flow of concrete through the pump creates the
risk of introducing air in the pump's pipe system. When air gets in the
pump's pipe system, the risk of hose whipping is created, which can
injure not only the pump operator, but any personnel within reach of
the hose.
    Secondly, concrete pump operators already take rest breaks
throughout the typical day that reflect the work flow at the job site,
so an additional minimum 30-minute rest break does not enhance job
safety.
    ACPA states that when concrete companies expect a 9-hour job and it
ends up being 2-3 hours longer, most of that additional time is spent
waiting on concrete and doing nothing more than recirculating the
concrete in the pump about every 10-15 minutes to avoid hardening and
the introduction of air pockets in the pipe system. Only a small
percentage of the concrete pump operator's time is spent driving. On
average, concrete pump operators spend between 25-32% of their time
driving during a shift, and average daily driving distances are 20-25
miles. Another 30-minute break limits the operator's ability to return
the concrete pump to the shop within the daily 14-hour driving window.
    According to ACPA, concrete is a perishable product. The perishable
nature of concrete also creates difficult schedule coordination issues
due to concrete being needed on a just-in-time basis. A concrete pump
operator cannot plan the timing of the 30-minute break, as they cannot
interrupt their work activity without the threat of failure--failure to
accept and deliver concrete within its perishable limits and failure by
violating their contracts. Once the ingredients of ready-mixed concrete
have been combined, there is a brief window during which the product
can be pumped (roughly 90 minutes before the concrete hardens). Should
the concrete pump operator be required to take a 30-minute off-duty
break, it would cause a ripple effect on the ready-mix concrete trucks
in line to supply the pump. Such a delay could cost thousands of
dollars to rectify and could potentially violate a delivery contract.
Once the concrete pump starts to receive a delivery, it must be
completed, without disruption to conduct a safe and structurally sound
pour.
    Furthermore, ACPA adds that concrete pumping and placement
companies work in collaboration with ready-mixed companies. Scheduling
local business contracts in compliance with State and Federal
regulations incorporating the 30-minute rest break is incredibly
complicated, verging on impossible in cases when some concrete
companies operate under different FMCSA rules. ACPA mentioned that the
ready-mixed drivers were granted an exemption from the minimum 30-
minute rest break provision.\2\ As a result of this, if a concrete pump
operator has worked 8 hours when the ready-mixed truck arrives, it is
impossible for the concrete pump operator to take his or her 30-minute
break since he/she has to place the concrete.
---------------------------------------------------------------------------

    \2\ More precisely, section 5521 of the Fixing America's Surface
Transportation (FAST) Act, exempts a ``driver of a ready mixed
concrete delivery vehicle'' from all of the normal hours-of-service
regulations, including the 30-minute break rule, who operates within
a 100 air-mile radius of his/her normal work reporting location and
meets certain other requirements [Pub. L. 114-94, 129 Stat. 1312,
1559, Dec. 4, 2015, codified at 49 U.S.C. 31502(f)]. In addition,
FMCSA granted drivers of ready mixed concrete trucks an exemption
from the 30-minute break requirement [80 FR 17819, April 2, 2015],
which section 5206(b)(1)(A) of the FAST Act made into permanent law
[129 Stat. 1312, 1537].
---------------------------------------------------------------------------

    ACPA believes that granting this exemption would achieve the same
level of safety provided by the rule requiring the 30-minute rest
break. The Association states that the concrete pumping industry has a
solid safety record, and that concrete pump operators already receive
numerous breaks throughout the work day. The ACPA Operation
Certification Program ensures, encourages, and educates the industry on
safe pumping and placement procedures. These safety practices allow
concrete operators to maintain their safety record through careful
training and well-developed safety guidelines.
    A copy of the ACPA's application for exemption is available for
review in the docket for this notice.

    Issued on: October 17, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-25755 Filed 10-24-16; 8:45 am]
 BILLING CODE 4910-EX-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on August 14, 2003

   NOTICE OF ACTION TAKEN -- DOCKET OST-2003-15729

________________________________________________________________________
_________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of    America West Airlines, Inc.          filed
7/21/2003  for:

XX  Exemption for two years under 49 U.S.C. 40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between a point or points in the United States, via intermediate points,
and a point or points in Costa Rica, and beyond.

Applicant rep:   Joanne W. Young,<PHONE_NUMBER>   DOT Analyst:  Gerald
Caolo,<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted, subject to conditions

The above action was effective when taken:  August 14, 2003, through
August 14, 2005

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and Costa Rica.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  XX Holder’s
certificates of public convenience and necessity

	   XX  Standard exemption conditions (attached)

________________________________________________________________________
______________

Conditions:  The authority granted to operate to third countries is
limited to countries with which the United States has signed open-skies
agreements and/or countries for which the carrier holds authority to
serve under certificates or exemptions issued by the Department, and for
which it holds route integration authority by virtue of either the
present action or other action of the Department.

________________________________________________________________________
______________

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that

(1) our action was consistent with Department policy; (2) grant of the
exemption authority was consistent with the public interest; and (3)
grant of the authority would not constitute a major regulatory action
under the Energy Policy and Conservation Act of 1975.  To the extent not
granted, we denied all requests in the referenced Docket.  We may amend,
modify, or revoke the authority granted in this Notice at any time
without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security.  To assure compliance with all applicable U.S.
Government requirements concerning security, the holder shall, before
commencing any new service (including charter flights) to or from a
foreign airport, contact its Principal Security Inspector (PSI) to
advise the PSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

08/2003

 America West initially plans to offer service between Phoenix and San
Jose.

 PAGE

 PAGE   2

08/2003


[Federal Register Volume 80, Number 26 (Monday, February 9, 2015)]
[Notices]
[Page 6954]
[FR Doc No: 2015-02429]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13214-003]

Lock 12 Hydro Partners, LLC; Kentucky Ravenna Hydroelectric
Project; Notice of Revised Restricted Service List

    Rule 2010 of the Federal Energy Regulatory Commission's
(Commission) Rules of Practice and Procedure, 18 CFR 385.2010, provides
that, to eliminate unnecessary expense or improve administrative
efficiency, the Secretary may establish a restricted service list for a
particular phase or issue in a proceeding. The restricted service list
should contain the names of persons on the service list who, in the
judgment of the decisional authority establishing the list, are active
participants with respect to the phase or issue in the proceeding for
which the list is established.
    The Commission staff is consulting with the Kentucky State Historic
Preservation Officer and the Advisory Council on Historic Preservation
(Advisory Council) pursuant to the Advisory Council's regulations, 36
CFR part 800, implementing section 106 of the National Historic
Preservation Act, as amended, (16 U.S.C. 470f), to prepare a
Programmatic Agreement for managing properties included in, or eligible
for inclusion in, the National Register of Historic Places at the
proposed Ravenna Hydroelectric Project.
    On November 21, 2013, Commission staff established a restricted
service list for the Ravenna Hydroelectric Project. Since that time,
changes have occurred and therefore, the restricted service list is
revised as follows:
    Replace ``Jill Howe, Kentucky Heritage Council'' with ``Kary
Stackelbeck, or Representative, Kentucky Heritage Council.''

    Dated: February 2, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-02429 Filed 2-6-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Notices]
[Page 73125]
[FR Doc No: 2016-25591]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3379-EM; Docket ID FEMA-2016-0001]

Georgia; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Georgia (FEMA-3379-EM), dated October 6,
2016, and related determinations.

DATES: Effective Date: October 6, 2016.

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: Notice is hereby given that, in a letter
dated October 6, 2016, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in the State of
Georgia resulting from Hurricane Matthew beginning on October 4,
2016, and continuing, are of sufficient severity and magnitude to
warrant an emergency declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(``the Stafford Act''). Therefore, I declare that such an emergency
exists in the State of Georgia.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), limited to direct Federal assistance, under the Public
Assistance program.
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Warren
J. Riley, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared emergency.
    The following areas of the State of Georgia have been designated as
adversely affected by this declared emergency:

    Appling, Atkinson, Bacon, Brantley, Bryan, Bulloch, Burke,
Camden, Candler, Charlton, Chatham, Clinch, Coffee, Echols,
Effingham, Emanuel, Evans, Glynn, Jeff Davis, Jenkins, Liberty,
Long, McIntosh, Pierce, Screven, Tattnall, Toombs, Treutlen, Ware,
and Wayne Counties for emergency protective measures (Category B),
limited to direct federal assistance, under the Public Assistance
program.
    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.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-25591 Filed 10-21-16; 8:45 am]
 BILLING CODE 9111-23-P


                     Index to Docket EPA-R09-OAR-2013-0449
  Determination of Attainment for the West Central Pinal Nonattainment Area
                For the 2006 Fine Particle Standard; Arizona;
      Determination Regarding Applicability of Clean Air Act Requirements

Category I.	Final Rule

[Reserved]

Category II. 	Proposed Rule

   1. Proposed Rule: "Determination of Attainment for the West Central Pinal Nonattainment Area for the 2006 Fine Particle Standard; Arizona; Determination regarding Applicability of Clean Air Act Requirements" June 26, 2013. (Pre-publication version)

   2. Proposed Rule: "Determination of Attainment for the West Central Pinal Nonattainment Area for the 2006 Fine Particle Standard; Arizona; Determination regarding Applicability of Clean Air Act Requirements" 78 FR 41901, July 12, 2013

Category III.	Official Public Comment on the NPRM

[Reserved]

Category IV.	Other Documents

   1. Conference Report on S 1630, Clean Air Act Amendments of 1990 (House of Representatives, October 26, 1990) - H.R. Rep. No. 490, 101st Cong., 2d Sess. 267 (1990)

   2. Memorandum from John S. Seitz, Director, Office of Air Quality Planning and Standards, "Reasonable Further Progress, Attainment Demonstration, and Related Requirements for Ozone Nonattainment Areas Meeting the Ozone National Ambient Air Quality Standard," May 10, 1995

   3. Sierra Club v. EPA, 99 F.3d 1551 (10th Cir. 1996) ; November 13, 1996

   4. Sierra Club v. EPA, 375 F. 3d 537 (7th Cir. 2004);  July 6, 2004

   5. Memorandum from Stephen Page, Director, EPA Office of Air Quality Planning and Standards, "Clean Data Policy for the Fine Particle National Ambient Air Quality Standards," December 14, 2004

   6. Our Children's Earth v. EPA, No. 04-73032 (9[th] Cir. June 28, 2005 (Memorandum Opinion))

   7. Latino Issues Forum v. EPA, Nos. 06-75831 and 08-71238 (9[th] Cir. March 2, 2009 (Memorandum Opinion))

   8. Natural Resources Defense Council v.EPA, 571 F. 3d 1245 (DC Cir. 2009); July 10, 2009

   9. Letter from Matthew Lakin, Manager, Air Quality Analysis Office, U.S. EPA Region IX, to Donald Gabrielson, Director, PCAQCD, November 1, 2010 (approving PCAQCD's "2010 Ambient Monitoring Network Plan and 2009 Data Summary")

   10. Letter from Kale Walch, Deputy Director, PCAQCD to Jared Blumenfeld, Regional Administrator, EPA Region IX, April 29, 2011 (certifying the ambient air quality data collected for year 2010)

   11. Letter from Matthew Lakin, Manager, Air Quality Analysis Office, U.S. EPA Region IX, to Donald Gabrielson, Director, PCAQCD, November 1, 2011 (approving PCAQCD's "2011 Annual Monitoring Network Plan and 2010 Data Summary")

   12. Email from Steve Calderon, Manager, State Implementation Plan Section, Air Quality Division, Arizona Department of Environmental Quality, to Colleen McKaughan, Associate Director, Air Division, U.S. EPA Region IX,  December 19, 2012

   13. Natural Resources Defense Council v. EPA, 706 F.3d 428 (D.C. Cir. 2013), January 4, 2013

   14. Email from Bryan C. Paris, Arizona Department of Environmental Quality, to Wienke Tax, US EPA Region 9, January 29, 2013

   15. Letter from Matthew Lakin, Manager, Air Quality Analysis Office, U.S. EPA Region IX, to Donald Gabrielson, Director, PCAQCD, March 27, 2013 (approving PCAQCD's "2012 Annual Monitoring Network Plan and 2011 Data Summary")

   16. Letter from Kale Walch, Deputy Director, PCAQCD to Jared Blumenfeld, Regional Administrator, EPA Region IX, April 26, 2013 (certifying the ambient air quality data collected for year 2012)

   17.  2010-2012 PM2.5 Design Value Report - EPA Air Quality System (AQS), May 23. 2013

   18. June 2013 Technical System Audit Report transmitted via correspondence from Deborah Jordan, Director, Air Division, EPA Region IX, to Don Gabrielson, Pinal County Air Quality Control District, June 10, 2013

   19.  2013 PM2.5 Preliminary Data Report - EPA Air Quality System (AQS), June 12, 2013

Category V.	Federal Register Notices

   1. 52 FR 24634	 July 1, 1987
   2. 57 FR 13498 	April 16, 1992
   3. 62 FR 38652	July 18, 1997
   4. 70 FR 71612	 November 29, 2005
   5. 71 FR 6352	February 8, 2006
   6. 71 FR 13021	March 14, 2006
   7. 71 FR 40023	July 14, 2006
   8. 71 FR 40952 	July 19, 2006
   9. 71 FR 44920	August 8, 2006
   10. 71 FR 61144	October 17, 2006
   11. 71 FR 63642	October 30, 2006
   12. 72 FR 14422	March 28, 2007
   13. 72 FR 20586	 April 25, 2007
   14. 73 FR 28321	May 16, 2008
   15. 74 FR 58688	November 13, 2009
   16. 75 FR 6570	February 10, 2010
   17. 75 FR 13710	March 23, 2010
   18. 75 FR 27944	May 19, 2010
   19. 76 FR 6056	February 3, 2011
   20. 77 FR 65310	October 26, 2012
   21. 77 FR 76427	December 28, 2012
   22. 78 FR 3086	January 15, 2013

Category VI.	Additional Materials Considered for the Final Rule

[RESERVED]


[Federal Register Volume 87, Number 201 (Wednesday, October 19, 2022)]
[Proposed Rules]
[Pages 63465-63467]
[FR Doc No: 2022-22393]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 55

[EPA-R03-OAR-2022-0776; FRL-10292-01-R3]

Outer Continental Shelf Air Regulations; Consistency Update for
Maryland

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; consistency update.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
update a portion of the Outer Continental Shelf (OCS) Air Regulations.
Requirements applying to OCS sources located within 25 miles of states'
seaward boundaries must be updated periodically to remain consistent
with the requirements of the corresponding onshore area (COA), as
mandated by the Clean Air Act (CAA). The portion of the OCS air
regulations that is being updated pertains to the requirements for OCS
sources for which Maryland is the designated COA. The State of
Maryland's requirements discussed in this document are proposed to be
incorporated by reference into the Code of Federal Regulations (CFR)
and listed in the appendix to the OCS air regulations.

DATES: Written comments must be received on or before November 18,
2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2022-0776 at www.regulations.gov, or via email to [email protected]. For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER

INFORMATION CONTACT section. For the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Gwendolyn Supplee, Permits Branch
(3AD10), Air & Radiation Division, U.S. Environmental Protection
Agency, Region III, Four Penn Center, 1600 John F. Kennedy Boulevard,
Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-
2763. Ms. Supplee can also be reached via electronic mail at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On September 4, 1992, EPA promulgated 40 CFR part 55,\1\ which
established requirements to control air pollution from OCS sources in
order to attain and maintain Federal and state ambient air quality
standards and to comply with the provisions of part C of title I of the
CAA. The regulations at 40 CFR part 55 apply to all OCS sources except
those located in the Gulf of Mexico west of 87.5 degrees longitude. See
40 CFR 55.3(a). Section 328 of the CAA requires that for such sources
located within 25 miles of a state's seaward boundary, the requirements
shall be the same as would be applicable if the sources were located in
the COA. Because the OCS requirements are based on onshore
requirements, and onshore requirements may change, Section 328(a)(1)
requires that EPA update the OCS requirements as necessary to maintain
consistency with onshore requirements.
---------------------------------------------------------------------------

    \1\ The reader may refer to the notice of proposed rulemaking,
December 5, 1991 (56 FR 63774), and the preamble to the final rule
promulgated September 4, 1992 (57 FR 40792) for further background
and information on the OCS regulations.
---------------------------------------------------------------------------

    Pursuant to 40 CFR 55.12, consistency reviews will occur: (1) at
least annually where an OCS activity is occurring within 25 miles of a
State seaward boundary; (2) upon receipt of a Notice of Intent (NOI)
under 40 CFR 55.4; or (3) when a state or local agency submits a rule
to EPA to be considered for incorporation by reference in 40 CFR part
55. This proposed action is being taken in response to the submittal
received by EPA on August 5, 2022, of a NOI, from US Wind, Inc., for
the proposed installation of an up to 2-gigawatt offshore wind energy
facility located approximately 10 nautical miles off the coast of
Maryland. Public comments received in writing within 30 days of
publication of this document will be considered by EPA before
publishing a final rule.
    Section 328(a) of the CAA requires that EPA establish requirements
to control air pollution from OCS sources located within 25 miles of
States' seaward boundaries that are the same as onshore requirements.
To comply with this statutory mandate, EPA must incorporate applicable
onshore rules into 40 CFR part 55 as they exist onshore. This limits
EPA's flexibility in deciding which requirements will be incorporated
into 40 CFR part 55 and prevents EPA from making substantive changes to
the requirements it incorporates. As a result, EPA may be incorporating
rules into 40 CFR part 55 that do not conform to all of EPA's state
implementation plan (SIP) guidance or certain requirements of the CAA.
Consistency updates may result in the inclusion of state or local rules
or regulations into 40 CFR part 55, even though the same rules may
ultimately be disapproved for inclusion as part of the SIP. Inclusion
in the OCS rule does not imply that a rule meets the requirements of
the CAA for SIP approval, nor does it imply that the rule will be
approved by EPA for inclusion in the SIP.

II. EPA Analysis

    EPA reviewed Maryland's rules for inclusion in 40 CFR part 55 to
ensure that they are rationally related to the attainment or
maintenance of Federal or state ambient air quality standards and
compliance with part C of title I of the CAA, that they are not
designed expressly to prevent exploration and development of the OCS,
and that they are potentially applicable to OCS sources. See 40 CFR
55.1. EPA has also evaluated the rules to ensure they are not arbitrary
or capricious. See 40 CFR 55.12(e). In addition, EPA has excluded
administrative or procedural rules, and requirements that regulate
toxics which are not related to the attainment and maintenance of
Federal and state ambient air quality standards.\2\
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    \2\ Each COA which has been delegated the authority to implement
and enforce 40 CFR part 55 will use its administrative and
procedural rules as onshore. However, in those instances where EPA
has not delegated authority to implement and enforce 40 CFR part 55,
EPA will use its own administrative and procedural requirements to
implement the substantive requirements. See 40 CFR 55.14(c)(4).
---------------------------------------------------------------------------

III. Proposed Action

    EPA last did a consistency update for Maryland on August 16, 2019
(84 FR 34065). In that action, EPA incorporated by reference into 40
CFR part 55 all of Maryland's regulations that EPA believed were
relevant to the OCS requirements. For this action, EPA has reviewed
changes that Maryland has made to its underlying regulatory programs.
This action will have no effect on any provisions that were not subject
to changes by Maryland and were also previously incorporated by
reference into 40 CFR part 55 through EPA's August 16, 2019 rule. The
rules that EPA proposes to incorporate are applicable provisions of the
Code of Maryland Regulations (COMAR).
    The intended effect of proposing approval of the OCS requirements
for the Maryland Department of the Environment (MDE) is to regulate
emissions from OCS sources in accordance with the requirements for
onshore sources. The Maryland regulatory changes EPA proposes to
incorporate are: (1) Chapter 8, Control of Incinerators--COMAR
26.11.08; (2) Chapter 17, Nonattainment Provisions for Major New
Sources and Major Modifications General--COMAR 26.11.17; and (3)
Chapter 20, Mobile Sources--COMAR 26.11.20. EPA is soliciting public
comments on the issues discussed in this document. These comments will
be considered before taking final action.

IV. Incorporation by Reference

    In this proposed rule, EPA is proposing to include in a final EPA
rule regulatory text that includes incorporation by reference. In
accordance with the requirements of 1 CFR 51.5, EPA is proposing to
incorporate by reference the Code of Maryland Regulations air rules
that are applicable to OCS sources and which are currently in effect.
These regulations are described in Section III (``Proposed Action'') of
this preamble. EPA has made, and will continue to make, these materials
available through www.regulations.gov and at the EPA Region III Office.
Please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to establish
requirements to control air pollution from OCS sources located within
25 miles of states' seaward boundaries that are the same as onshore air
pollution control requirements. To comply with this statutory mandate,
the EPA must incorporate applicable onshore rules into 40 CFR part 55
as they exist onshore. See 42 U.S.C. 7627(a)(1); 40 CFR 55.12. Thus, in
promulgating OCS consistency updates, EPA's role is to maintain
consistency between OCS

regulations and the regulations of onshore areas, provided that they
meet the criteria of the CAA. Accordingly, this action simply updates
the existing OCS requirements that have been revised since the last
consistency review to make them consistent with requirements onshore,
without the exercise of any policy direction by EPA. For that reason,
this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et
seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    This proposed rulemaking incorporating by reference sections of
COMAR does not apply on any Indian reservation land as defined in 18
U.S.C. 1151 or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, this rule incorporating by reference sections of COMAR does
not have tribal implications and will not impose substantial direct
costs on tribal governments or preempt tribal law as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).
    This action does not impose any new information collection burden
under the PRA. Office of Management and Budget (OMB) has previously
approved the information collection activities contained in the
existing regulations at 40 CFR part 55 and, by extension, this update
to part 55, and has assigned OMB control number 2060-0249. This action
does not impose a new information burden under PRA because this action
only updates the state rules that are incorporated by reference into 40
CFR part 55, appendix A.\3\
---------------------------------------------------------------------------

    \3\ OMB's approval of the Information Collection Request (ICR)
can be viewed at www.reginfo.gov.
---------------------------------------------------------------------------

    EPA is proposing to incorporate the rules potentially applicable to
sources for which the State of Maryland will be the COA that have been
revised since the last consistency review. The rules that EPA proposes
to incorporate are applicable provisions of the Code of Maryland
Regulations.

List of Subjects in 40 CFR Part 55

    Environmental protection, Administrative practice and procedure,
Air pollution control, Carbon monoxide, Incorporation by reference,
Intergovernmental relations, Lead, Nitrogen dioxide, Outer continental
shelf, Ozone, Particulate matter, Permits, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

Adam Ortiz,
Regional Administrator, Region III.

    For the reasons set out in the preamble, title 40 of the Code of
Federal Regulations, part 55, is proposed to be amended as follows.

PART 55--OUTER CONTINENTAL SHELF AIR REGULATIONS

0
1. The authority citation for part 55 continues to read as follows:

    Authority:  Section 328 of the Clean Air Act (42 U.S.C. 7401 et
seq.) as amended by Pub. L. 101-549.

0
2. Section 55.14 is amended by revising paragraph (e)(10)(i)(A) to read
as follows:

Sec.  55.14   Requirements that apply to OCS sources located within 25
miles of States' seaward boundaries, by State.

* * * * *
    (e) * * *
    (10) * * *
    (i) * * *

(A) State of Maryland Requirements Applicable to OCS Sources, July 28,
2022.

* * * * *
0
3. Appendix A to 40 CFR part 55 is amended by revising paragraph (a)(1)
under the heading ``Maryland'' to read as follows:

Appendix A to Part 55--Listing of State and Local Requirements
Incorporated by Reference into Part 55, by State

* * * * *

Maryland

    (a) State requirements.
    (1) The following State of Maryland requirements are applicable
to OCS Sources, July 28, 2022, State of Maryland--Department of the
Environment.
    The following sections of Code of Maryland Regulations (COMAR)
Title 26 Subtitle 11:

COMAR 26.11.01--General Administrative Provisions (Effective as of
December 6, 2018)
COMAR 26.11.02--Permits, Approvals, and Registrations (Effective as
of February 12, 2018)
COMAR 26.11.03--Permits, Approvals, and Registration- Title V
Permits (Effective as of November 12, 2010)
COMAR 26.11.05--Air Pollution Episode System (Effective as of
November 12, 2010)
COMAR 26.11.06--General Emission Standards, Prohibitions, and
Restrictions (Effective as of July 02, 2013)
COMAR 26.11.07--Open Fires (Effective as of November 12, 2010)
COMAR 26.11.08--Control of Incinerators (Effective as of May 4,
2020)
COMAR 26.11.09--Control of Fuel-Burning Equipment, Stationary
Internal Combustion Engines and Certain Fuel-Burning Installations
(Effective as of December 6, 2018)
COMAR 26.11.13--Control of Gasoline and Volatile Organic Compound
Storage and Handling (Effective as of July 21, 2014)
COMAR 26.11.15--Toxic Air Pollutants (Effective as of November 12,
2010)
COMAR 26.11.16--Procedures Related to Requirements for Toxic Air
Pollutants (Effective as of November 12, 2010)
COMAR 26.11.17--Nonattainment Provisions for Major New Sources and
Major Modifications (Effective as of December 30, 2019)
COMAR 26.11.19--Volatile Organic Compounds from Specific Processes
(Effective as of September 28, 2015)
COMAR 26.11.20--Mobile Sources (Effective as of February 7, 2022)
COMAR 26.11.26--Conformity (Effective as of November 12, 2010)
COMAR 26.11.35--Volatile Organic Compounds from Adhesives and
Sealants (Effective as of November 12, 2010)
COMAR 26.11.36--Distributed Generation (Effective as of February 12,
2018)
COMAR 26.11.39--Architectural and Industrial Maintenance (AIM)
Coatings (Effective as of April 2016)
* * * * *
[FR Doc. 2022-22393 Filed 10-18-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Notices]
[Pages 27235-27236]
[FR Doc No: 2012-11106]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0442]

Jerome Lentini; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is denying Jerome
Lentini's request for a hearing and is issuing an order under the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently
debarring Lentini from providing services in any capacity to a person
that has an approved or pending drug product application. FDA bases
this order on a finding that Lentini was convicted of a felony under
Federal law for conduct relating to the development or approval of a
drug product or otherwise relating to the regulation of a drug product
under the FD&C Act. Lentini has failed to file with the Agency
information and analyses sufficient to create a basis for a hearing
concerning this action.

DATES: The order is effective May 9, 2012.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: G. Matthew Warren, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave. Bldg. 32, Rm. 4210, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 11, 2006, the United States District Court for the
District of Oregon entered a criminal judgment against Lentini pursuant
to his guilty plea. Lentini, formerly a medical doctor at ``A Younger
You'' clinic, pled guilty to a felony under the FD&C Act, namely
misbranding a drug with an intent to defraud or mislead while it was
held for sale after shipment in interstate commerce in violation of
sections 301(k) and 303(a)(2) of the FD&C Act (21 U.S.C. 331(k) and
333(a)(2)) and 18 U.S.C. 2. The basis for this conviction was Lentini's
admission that he misled patients from November 2003 through December
2004, by injecting them with a drug product that he offered for sale as
BOTOX/BOTOX Cosmetic (BOTOX). In fact, as defendant Lentini knew, he
did not generally use BOTOX on patients but instead used another drug
derived from botulinum toxin type A that had not been approved by FDA.
    Lentini is subject to debarment based on a finding, under section
306(a)(2) of the FD&C Act (21 U.S.C. 335a(2)), that he was convicted of
a felony under Federal law for conduct relating to the development or
approval of a drug product or otherwise relating to the regulation of a
drug product under the FD&C Act. By letter dated February 7, 2011, FDA
notified Lentini of a proposal to permanently debar him from providing
services in any capacity to a person having an approved or pending drug
product application. In a letter dated February 19, 2011, Lentini
requested a hearing on the proposal. In his request for a hearing,
Lentini acknowledges his convictions under Federal law, as alleged by
FDA, but he argues that he is actually innocent of the offense
underlying his felony conviction.
    Hearings will not be granted on issues of policy or law, on mere
allegations, denials, or general descriptions of positions and
contentions, or on data and information insufficient to justify the
factual determination urged (see 21 CFR 12.24(b)).
    The Chief Scientist and Deputy Commissioner for Science and Public
Health has considered Lentini's arguments and concludes that they are
unpersuasive and fail to raise a genuine and substantial issue of fact
requiring a hearing.

II. Arguments

    In his request for a hearing, Lentini first argues that he did not
misbrand the drug product at issue. Instead, he argues that the
manufacturer of the drug product, Toxin Research International, Inc.
(TRI), misbranded the product. As stated in the indictment in Lentini's
criminal proceedings, however, a drug is misbranded under section
502(i)(3) of the FD&C Act (21 U.S.C. 352(i)(3)) if a drug ``is offered
for sale under the name of another drug.'' The specific count to which
Lentini pled guilty charged him with ``misbrand[ing] a drug, namely

Botulinum Toxin Type A manufactured by [TRI] and known as `TRI-toxin,'
* * * in that [he] offered the ``TRI-toxin for sale by injection to
patients under the name of another drug, [BOTOX].'' In short, Lentini
pled guilty to, and was convicted of, misbranding a drug under the FD&C
Act.
    Section 306(a)(2) of the FD&C Act provides FDA with authority debar
an individual who has been convicted of certain Federal felonies. The
only relevant factual issue is whether Lentini was, in fact, convicted
of a felony under Federal law for conduct relating to the development
or approval of a drug product or otherwise relating to the regulation
of a drug product under the FD&C Act. Lentini does not dispute that he
pled guilty to violating the requirements for drugs under the FD&C Act.
Section 306(l) of the FD&C Act includes in its definition of a
conviction, a guilty plea. Accordingly, Lentini's arguments regarding
the factual circumstances underlying his plea fail to raise a genuine
and substantial issue of fact as to whether he was convicted of a
felony under Federal law for conduct relating to the development or
approval of a drug product or otherwise relating to the regulation of a
drug product under the FD&C Act. Whether TRI also misbranded the drug
is immaterial to the conduct underlying Lentini's conviction.
    Lentini next argues that he entered the guilty plea underlying his
felony conviction while under ``extreme duress'' and only because his
attorneys advised him that the prosecution would ``find a way to
convict him legally or illegally'' and that he should sign the plea
agreement ``despite the facts.'' In Lentini's petition to enter a
guilty plea in the criminal proceedings, however, he specifically
attested that he was voluntarily agreeing to plead guilty because he
was guilty of the offense underlying his conviction. He also stated in
the petition that he had carefully reviewed every part of the agreement
with his attorney and that the attorney counseled and advised him on
the nature and elements of the charge to which he was pleading guilty,
as well as any possible defenses. Under these circumstances, and in
light of the court's acceptance of his guilty plea, Lentini's mere
allegation that he was actually innocent of the offense and signed the
plea agreement only at the urging of his attorney is insufficient to
create a genuine and substantial issue of fact for resolution at a
hearing. (See 21 CFR 12.24(b)(1)-(2)). Moreover, the FD&C Act does not
permit consideration of factors such as the circumstances of an
individual's guilty plea. As stated in this document, section 306(a)(2)
the FD&C Act is clear that an individual shall be debarred upon a
finding that he has been convicted of a felony under Federal law for
conduct relating to the development or approval of a drug product or
otherwise relating to the regulation of a drug product under the FD&C
Act. Lentini has been convicted of such a felony and is thus subject to
debarment. If a court were to reverse Lentini's conviction on the
ground that his plea was involuntary, or for any other reason, the
order of debarment would be withdrawn pursuant to section
306(d)(3)(B)(i) of the FD&C Act.

III. Findings and Order

    Therefore, the Chief Scientist and Deputy Commissioner for Science
and Public Health, under section 306(a)(2) of the FD&C Act and under
authority delegated to him, finds that Mr. Lentini has been convicted a
of a felony under Federal law for conduct relating to the development
or approval of a drug product or otherwise relating to the regulation
of a drug product under the FD&C Act.
    As a result of the foregoing findings, Lentini is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application under section 505, 512, or
802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351
of the Public Health Service Act (42 U.S.C. 262), effective May 9, 2012
(21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 21 U.S.C. 321(dd)). Any
person with an approved or pending drug product application who
knowingly uses the services of Lentini, in any capacity during his
period of debarment, will be subject to civil money penalties. If
Lentini, during his period of debarment, provides services in any
capacity to a person with an approved or pending drug product
application, he will be subject to civil money penalties. In addition,
FDA will not accept or review any abbreviated new drug applications
submitted by or with the assistance of Lentini during his period of
debarment.
    Any application by Lentini for termination of debarment under
section 306(d) of the FD&C Act should be identified with Docket No.
FDA-2010-N-0442 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Persons with access to the Internet may obtain documents in the Docket
at http://www.regulations.gov.

    Dated: April 16, 2012.
Jesse L. Goodman,
Chief Scientist and Deputy Commissioner for Science and Public Health.
[FR Doc. 2012-11106 Filed 5-8-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 118 (Tuesday, June 21, 2022)]
[Notices]
[Pages 36864-36865]
[FR Doc No: 2022-13211]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1997]

Food and Drug Administration Oversight of Food Covered by Systems
Recognition Arrangements; Guidance for Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for FDA staff entitled ``FDA
Oversight of Food Covered by Systems Recognition Arrangements.'' This
guidance provides recommendations related to FDA's regulatory oversight
activities for food covered by a Systems Recognition Arrangement (SRA)
and imported from countries whose food safety systems FDA has
recognized in SRAs.

DATES: The announcement of the guidance is published in the Federal
Register on June 21, 2022.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-1997 for ``FDA Oversight of Food Covered by Systems
Recognition Arrangements; Guidance for FDA Staff.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests for a single hard copy of the
guidance entitled ``FDA Oversight of Food Covered by Systems
Recognition Arrangements'' to the Office of Strategic Planning and
Operational Policy, Office of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr., Element Building, Rm. 4148,
Rockville, MD 20857. Send one self-addressed adhesive label to assist
that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Marla Hallacy, Office of Regulatory
Affairs, Division of Operational Policy, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for FDA staff
entitled ``FDA Oversight of Food Covered by Systems Recognition
Arrangements; Guidance for FDA Staff.'' The guidance is part of FDA's
larger effort to take a risk-based approach to food safety to include
ensuring the safety of imported food, consistent with the FDA Food
Safety Modernization Act. The guidance covers FDA's regulatory
oversight activities for food covered by SRAs between FDA and its
foreign regulatory counterparts. Currently, FDA has signed SRAs with
food safety agencies in Australia, Canada, and New Zealand.

    On July 12, 2021, FDA made available the draft guidance entitled
``FDA Oversight of Food Products Covered by Systems Recognition
Arrangements; Draft Guidance for Food and Drug Administration Staff''
in the Federal Register (86 FR 36559). The comment period closed on
September 10, 2021. FDA received no comments on the draft guidance. The
Agency made minor editorial changes to the guidance to improve clarity.
The guidance announced in this notice finalizes the draft guidance.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the topic of SRA implementation. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information regarding the Foreign Supplier Verification Program have
been approved under OMB control number 0910-0752, the collections of
information regarding the Hazard Analysis and Critical Control Point
Procedures for the Safe and Sanitary Processing and Importing of Juice
have been approved under OMB control number 0910-0466, and the
collections of information regarding the Hazard Analysis and Critical
Control Point Procedures for the Safe and Sanitary Processing and
Importing of Fish and Fishery Products have been approved under OMB
control number 0910-0354.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.regulations.gov.

    Dated: June 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13211 Filed 6-17-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 60 (Thursday, March 28, 2019)]
[Notices]
[Pages 11780-11781]
[FR Doc No: 2019-05984]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2012-0526; FRL-9991-23-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Aluminum, Copper and Other Non-
Ferrous Metals Foundries (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NESHAP for Aluminum, Copper and
Other Non-ferrous Metals Foundries (EPA ICR Number 2332.05, OMB Control
Number 2060-0630), to the Office of Management and Budget (OMB) for
review and approval in accordance with the Paperwork Reduction Act.
This is a proposed extension of the ICR, which is currently approved
through March 31, 2019. Public comments were previously requested, via
the Federal Register, on May 30, 2018 during a 60-day comment period.
This notice allows for an additional 30 days for public comments. A
fuller description of the ICR is given below, including its estimated
burden and cost to the public. An agency may neither conduct nor
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before April 29,
2019.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2012-0526, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change, including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov, or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Aluminum, Copper and Other Non-ferrous Metals
Foundries apply to both existing and new facilities conducting melting
operations located at an aluminum, copper, or other non-ferrous foundry
that is an area source of hazardous air pollutants (HAP) emissions,
melts 600 tons per year (tpy) of aluminum, copper, or other non-ferrous
metal or greater, and uses material that contains or has the potential
to emit HAP for which the source category was listed. New facilities
include those that commenced construction, modification or
reconstruction after the date of proposal. In general, all NESHAP
standards require initial notifications, performance tests, and
periodic reports by the owners/operators of the affected facilities.
They are also required to maintain records of the occurrence and
duration of any startup, shutdown, or malfunction in the operation of
an affected facility, or any period during which the monitoring system
is inoperative. These notifications, reports, and records are essential
in determining compliance, and are required of all affected facilities
subject to NESHAP. This information is being collected to assure
compliance with 40 CFR part 63, subpart ZZZZZZ.
    Form Numbers: None.
    Respondents/affected entities: Aluminum, copper, and other non-
ferrous foundries.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart ZZZZZZ).
    Estimated number of respondents: 318 (total).
    Frequency of response: Initially, occasionally and semiannually.
    Total estimated burden: 11,900 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $1,360,000 (per year), which includes $0 for
annualized capital/startup and/or operation & maintenance costs.
    Changes in the Estimates: There is no change in the labor hours in
this ICR compared to the previous ICR. This is due to two
considerations: (1) The regulations have not changed over the past
three years and are not anticipated to change over the next three
years; and (2) the growth rate for the industry is very low, negative
or non-existent, so

there is no significant change in the overall burden.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2019-05984 Filed 3-27-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: January 11, 2008 (Volume 73, Number 8)]
[Notices]
[Page 2069-2070]
[DOCID:fr11ja08-79]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold the following meeting during the week
of January 14, 2008:
    A Closed Meeting will be held on Tuesday, January 15, 2008 at 2
p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters may also be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5

U.S.C. 552b(c)(3), (4), (5), (7), (9)(B), and (10) and 17 CFR
200.402(a)(3), (4), (5), (7), 9(ii) and (10), permit consideration of
the scheduled matters at the Closed Meeting.
    Commissioner Nazareth, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matter of the Closed Meeting scheduled for Tuesday,
January 15, 2008 will be:
    Formal orders of investigations;
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings of an
enforcement nature;
    Regulatory matters regarding financial institutions;
    An opinion;
    Resolution of a litigation claim;
    Other matters related to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: January 8, 2008.
Nancy M. Morris,
Secretary.
 [FR Doc. E8-405 Filed 1-10-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: September 7, 2007 (Volume 72, Number 173)]
[Notices]
[Page 51479-51481]
[DOCID:fr07se07-100]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 27964; 812-13408]

Trust for Professional Managers, Inc., et al.; Notice of
Application

 August 31, 2007.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940 (``Act'') for an exemption from section
15(a) of the Act and rule 18f-2 under the Act, as well as from certain
disclosure requirements.

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    Summary of the Application: Applicants request an order that that
would permit them to enter into and materially amend subadvisory
agreements without shareholder approval and would grant relief from
certain disclosure requirements.
    Applicants: Trust for Professional Managers (the ``Trust'') and
Envestnet Asset Management, Inc. (the ``Adviser'').
    Filing Dates: The application was filed on July 17, 2007 and
amended on August 31, 2007.
    Hearing or Notification of Hearing: An order granting the
application will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on September 25, 2007 and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request by
writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street, NE., Washington, DC 20549-1090. Applicants, 615 East Michigan
Street; Milwaukee, WI 53202.

FOR FURTHER INFORMATION CONTACT: Lewis B. Reich, Senior Counsel, at
(202) 551-6919, or Nadya B. Roytblat, Assistant Director, at (202) 551-
6821 (Office of Investment Company Regulation, Division of Investment
Management).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained for a fee at the
Commission's Public Reference Branch,

100 F Street, NE., Washington, DC 20549-0102 (telephone (202) 551-
5850).

Applicants' Representations

    1. The Trust, a Delaware statutory trust organized as a series
investment company, is registered under the Act as an open-end
management investment company and currently offers thirteen series, six
of which are advised by the Adviser (``Funds'').\1\ The Adviser, a
wholly-owned subsidiary of Envestnet Asset Management Group, Inc., is
registered as an investment adviser under the Investment Advisers Act
of 1940 (``Advisers Act''), and serves as investment adviser to the
Funds under an investment advisory agreement with the Trust (``Advisory
Agreement'') that has been approved by the Trust's board of trustees
(``Board''), including a majority of the trustees who are not
``interested persons,'' as defined in section 2(a)(19) of the Act, of
either the Trust or the Adviser (``Independent Trustees''), as well as
by the shareholders of each Fund.
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    \1\ Applicants also request relief with respect to future series
of the Trust and any other existing or future registered open-end
management investment company or series thereof that: (a) Is advised
by the Adviser or a person controlling, controlled by, or under
common control with the Adviser or its successors; (b) uses the
management structure described in the application; and (c) complies
with the terms and conditions of the application (included in the
term ``Funds''). For purposes of the requested order, ``successor''
is limited to an entity or entities that result from a
reorganization into another jurisdiction or a change in the type of
business organization. The only existing registered open-end
management investment company that currently intends to rely on the
requested order is named as an applicant. If the name of any Fund
contains the name of a Subadviser (as defined below), the name of
the Adviser or the name of the entity controlling, controlled by, or
under common control with the Adviser that serves as the primary
adviser to the Fund will precede the name of the Subadviser.
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    2. Under the terms of the Advisory Agreement, the Adviser provides
each Fund with overall management services and continuously reviews,
supervises and administers each Fund's investment program, subject to
the supervision of, and policies established by, the Board, and has the
authority, subject to the approval of the Board and Fund shareholders,
to enter into investment subadvisory agreements (``Subadvisory
Agreements'') with one or more subadvisers (``Subadvisers''). The
Adviser has entered into Subadvisory Agreements with various
Subadvisers to provide investment advisory services to the Funds. Each
Subadviser is, and every future Subadviser will be, registered as an
investment adviser under the Advisers Act. The Adviser monitors and
evaluates the Subadvisers and recommends to the Board their hiring,
retention or termination. Subadvisers recommended to the Board by the
Adviser are selected and approved by the Board, including a majority of
the Independent Trustees. Each Subadviser has discretionary authority
to invest the assets or a portion of the assets of a particular Fund.
The Adviser compensates each Subadviser out of the fees paid to the
Adviser under the Advisory Agreement.
    3. Applicants request an order to permit the Adviser, subject to
Board approval, to enter into and materially amend Subadvisory
Agreements without obtaining shareholder approval. The requested relief
will not extend to any Subadviser that is an affiliated person, as
defined in section 2(a)(3) of the Act, of the Trust or of the Adviser,
other than by reason of serving as a subadviser to one or more of the
Funds (``Affiliated Subadviser'').
    4. Applicants also request an exemption from the various disclosure
provisions described below that may require a Fund to disclose fees
paid by the Adviser to each Subadviser. An exemption is requested to
permit the Trust to disclose for each Fund (as both a dollar amount and
as a percentage of each Fund's net assets): (a) The aggregate fees paid
to the Adviser and any Affiliated Subadvisers; and (b) the aggregate
fees paid to Subadvisers other than Affiliated Subadvisers (``Aggregate
Fee Disclosure''). Any Fund that employs an Affiliated Subadviser will
provide separate disclosure of any fees paid to the Affiliated
Subadviser.

Applicants' Legal Analysis

    1. Section 15(a) of the Act provides, in relevant part, that is
unlawful for any person to act as an investment adviser to a registered
investment company except pursuant to a written contract that has been
approved by a vote of a majority of the company's outstanding voting
securities. Rule 18f-2 under the Act provides that each series or class
of stock in a series investment company affected by a matter must
approve that matter if the Act requires shareholder approval.
    2. Form N-1A is the registration statement used by open-end
investment companies. Item 14(a)(3) of Form N-1A requires disclosure of
the method and amount of the investment adviser's compensation.
    3. Rule 20a-1 under the Act requires proxies solicited with respect
to an investment company to comply with Schedule 14A under the
Securities Exchange Act of 1934 (``1934 Act''). Items 22(c)(1)(ii),
22(c)(1)(iii), 22(c)(8) and 22(c)(9) of Schedule 14A, taken together,
require a proxy statement for a shareholder meeting at which the
advisory contract will be voted upon to include the ``rate of
compensation of the investment adviser,'' the ``aggregate amount of the
investment adviser's fees,'' a description of the ``terms of the
contract to be acted upon,'' and, if a change in the advisory fee is
proposed, the existing and proposed fees and the difference between the
two fees.
    4. Form N-SAR is the semi-annual report filed with the Commission
by registered investment companies. Item 48 of Form N-SAR requires
investment companies to disclose the rate schedule for fees paid to
their investment advisers, including the Subadvisers.
    5. Regulation S-X sets forth the requirements for financial
statements required to be included as part of investment company
registration statements and shareholder reports filed with the
Commission. Sections 6-07(2)(a), (b), and (c) of Regulation S-X require
that investment companies include in their financial statements
information about investment advisory fees.
    6. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provisions of the Act, or
from any rule thereunder, if such exemption is necessary or appropriate
in the public interest and consistent with the protection of investors
and the purposes fairly intended by the policy and provisions of the
Act. Applicants state that their requested relief meets this standard
for the reasons discussed below.
    7. Applicants assert that the shareholders rely on the Adviser's
experience to select one or more Subadvisers best suited to achieve a
Fund's investment objectives. Applicants assert that, from the
perspective of the investor, the role of the Subadvisers is comparable
to that of the individual portfolio managers employed by traditional
investment company advisory firms. Applicants state that requiring
shareholder approval of each Subadvisory Agreement would impose costs
and unnecessary delays on the Funds, and may preclude the Adviser from
acting promptly in a manner considered advisable by the Board.
Applicants note that the Advisory Agreement and any Subadvisory
Agreement with an Affiliated Subadviser will remain subject to section
15(a) of the Act and rule 18f-2 under the Act.
    8. Applicants assert that some Subadvisers use a ``posted'' rate
schedule to set their fees. Applicants state that while Subadvisers are
willing

to negotiate fees that are lower than those posted on the schedule,
they are reluctant to do so where the fees are disclosed to other
prospective and existing customers. Applicants submit that the
requested relief will encourage potential Subadvisers to negotiate
lower subadvisory fees with the Adviser.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. Before a Fund may rely on the order requested in the
application, the operation of the Fund in the manner described in the
application will be approved by a majority of the Fund's outstanding
voting securities, as defined in the Act, or, in the case of a Fund
whose public shareholders purchase shares on the basis of a prospectus
containing the disclosure contemplated by condition 2 below, by the
sole initial shareholder before offering the Fund's shares to the
public.
    2. The prospectus for each Fund will disclose the existence,
substance, and effect of any order granted pursuant to the Application.
Each Fund will hold itself out to the public as employing the
management structure described in the Application. The prospectus will
prominently disclose that the Adviser has ultimate responsibility
(subject to oversight by the Board) to oversee the Subadvisers and
recommend their hiring, termination, and replacement.
    3. Within 90 days of the hiring of any new Subadviser, the affected
Fund shareholders will be furnished all information about the new
Subadviser that would be included in a proxy statement, except as
modified to permit Aggregate Fee Disclosure. This information will
include Aggregate Fee Disclosure and any change in that disclosure
caused by the addition of the new Subadviser. To meet this obligation,
the Fund will provide shareholders within 90 days of the hiring of a
new Subadviser with an information statement meeting the requirements
of Regulation 14C, Schedule 14C, and Item 22 of Schedule 14A under the
1934 Act, except as modified by the order to permit Aggregate Fee
Disclosure.
    4. The Adviser will not enter into a Subadvisory Agreement with any
Affiliated Subadviser without that agreement, including the
compensation to be paid thereunder, having been approved by the
shareholders of the applicable Fund.
    5. At all times, at least a majority of the Board will be
Independent Trustees, and the nomination of new or additional
Independent Trustees will be placed within the discretion of the then-
existing Independent Trustees.
    6. When a Subadviser change is proposed for a Fund with an
Affiliated Subadviser, the Board, including a majority of the
Independent Trustees, will make a separate finding, reflected in the
applicable Board minutes, that such change is in the best interests of
the Fund and its shareholders and does not involve a conflict of
interest from which the Adviser or the Affiliated Subadviser would
derive an inappropriate advantage.
    7. Independent counsel, as defined in rule 0-1(a)(6) under the Act,
will be engaged to represent the Independent Trustees. The selection of
such counsel will be within the discretion of the then existing
Independent Trustees.
    8. The Adviser will provide the Board, no less frequently than
quarterly, with information about the profitability of the Adviser on a
per-Fund basis. The information will reflect the impact on
profitability of the hiring or termination of any Subadviser during the
applicable quarter.
    9. Whenever a Subadviser is hired or terminated, the Adviser will
provide the Board with information showing the expected impact on the
profitability of the Adviser.
    10. The Adviser will provide general management services to each
Fund, including overall supervisory responsibility for the general
management and investment of the Fund's assets and, subject to review
and approval of the Board, will (i) set each Fund's overall investment
strategies; (ii) evaluate, select and recommend Subadvisers to manage
all or part of a Fund's assets; (iii) when appropriate, allocate and
reallocate a Fund's assets among multiple Subadvisers; (iv) monitor and
evaluate the performance of Subadvisers; and (v) implement procedures
reasonably designed to ensure that the Subadvisers comply with each
Fund's investment objective, policies and restrictions.
    11. No director or officer of the Trust, or director or officer of
the Adviser, will own directly or indirectly (other than through a
pooled investment vehicle that is not controlled by such person) any
interest in a Subadviser, except for (a) ownership of interests in the
Adviser or any entity that controls, is controlled by, or is under
common control with the Adviser; or (b) ownership of less than 1% of
the outstanding securities of any class of equity or debt of a publicly
traded company that is either a Subadviser or an entity that controls,
is controlled by, or is under common control with a Subadviser.
    12. Each Fund will disclose in its registration statement the
Aggregate Fee Disclosure.
    13. The requested order will expire on the effective date of Rule
15a-5 under the Act, if adopted.

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-17698 Filed 9-6-07; 8:45 am]

BILLING CODE 8010-01-P