[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)]
[Proposed Rules]
[Pages 51887-51889]
[FR Doc No: 2018-21966]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0899; Product Identifier 2018-NM-099-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 757 airplanes. This proposed AD was
prompted by an evaluation by the design approval holder (DAH)
indicating that the inner skin at the lower fastener row is subject to
widespread fatigue damage (WFD). This proposed AD would require a
general visual inspection of certain lap splice inspection areas for
any repair common to the fuselage skin lap splice inspection areas,
repetitive dual frequency eddy current (DFEC) inspections of a certain
lap splice inner skin for any crack, and applicable on-condition
actions. We are proposing this AD to address the unsafe condition on
these products.

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

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Boeing
Commercial Airplanes, Attention: Contractual & Data Services (C&DS),
2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600;
telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may
view this referenced service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>. It
is also available on the internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2018-0899.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0899; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (phone: 800-647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: David Truong, Aerospace Engineer,
Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount
Boulevard, Lakewood, CA 90712 4137; phone:<PHONE_NUMBER>; fax: 562-627-
5210; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0899;
Product Identifier 2018-NM-099-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM because
of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Fatigue damage can occur locally, in small areas or structural
design details, or globally, in widespread areas. Multiple-site damage
is widespread damage that occurs in a large structural element such as
a single rivet line of a lap splice joining two large skin panels.
Widespread damage can also occur in multiple elements such as adjacent
frames or stringers. Multiple-site damage and multiple-element damage
cracks are typically too small initially to be reliably detected with
normal inspection methods. Without intervention, these cracks will
grow, and eventually compromise the structural integrity of the
airplane. This condition is known as WFD. It is associated with general
degradation of large areas of structure with similar structural details
and stress levels. As an airplane ages, WFD will likely occur, and will
certainly occur if the airplane is operated long enough without any
intervention.
    The FAA's WFD final rule (75 FR 69746, November 15, 2010) became
effective on January 14, 2011. The WFD rule requires certain actions to
prevent structural failure due to WFD throughout the operational life
of certain existing transport category airplanes and all of these
airplanes that will be certificated in the future. For existing and
future airplanes subject to the WFD rule, the rule requires that DAHs
establish a limit of validity (LOV) of the engineering data that
support the structural maintenance program. Operators affected by the
WFD rule may not fly an airplane beyond its LOV, unless an extended LOV
is approved.
    The WFD rule (75 FR 69746, November 15, 2010) does not require
identifying and developing maintenance actions if the DAHs can show
that such actions are not necessary to prevent WFD before the airplane
reaches the LOV. Many LOVs, however, do depend on accomplishment of
future maintenance actions. As stated in the WFD rule, any maintenance
actions necessary to reach the LOV will be mandated by airworthiness
directives through separate rulemaking actions.

    In the context of WFD, this action is necessary to enable DAHs to
propose LOVs that allow operators the longest operational lives for
their airplanes, and still ensure that WFD will not occur. This
approach allows for an implementation strategy that provides
flexibility to DAHs in determining the timing of service information
development (with FAA approval), while providing operators with
certainty regarding the LOV applicable to their airplanes.
    We have received a report indicating the inner skin at the lower
fastener row is subject to WFD. The inner skin at the lap splice could
also have scratches that can grow into scratch cracks, which could
interact with multi-site damage (MSD) fastener hole fatigue cracking.
This condition, if not addressed, could result in accelerated crack
growth rate, which could result in reduced structural integrity of the
airplane.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Requirements Bulletin 757-53A0111 RB,
dated May 21, 2018. The service information describes procedures for a
general visual inspection of certain lap splice inspection areas for
any repair common to the fuselage skin lap splice inspection areas,
repetitive DFEC inspections of the S-14 lap splice inner skin for any
crack, and applicable on-condition actions. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishment of the actions
identified in Boeing Alert Requirements Bulletin 757-53A0111 RB, dated
May 21, 2018, described previously, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
    For information on the procedures and compliance times, see this
service information at http://www.regulations.gov by searching for and
locating Docket No. FAA-2018-0899.

Explanation of Requirements Bulletin

    The FAA worked in conjunction with industry, under the
Airworthiness Directives Implementation Aviation Rulemaking Committee
(AD ARC), to enhance the AD system. One enhancement is a process for
annotating which steps in the service information are ``required for
compliance'' (RC) with an AD. Boeing has implemented this RC concept
into Boeing service bulletins.
    In an effort to further improve the quality of ADs and AD-related
Boeing service information, a joint process improvement initiative was
worked between the FAA and Boeing. The initiative resulted in the
development of a new process in which the service information more
clearly identifies the actions needed to address the unsafe condition
in the ``Accomplishment Instructions.'' The new process results in a
Boeing Requirements Bulletin, which contains only the actions needed to
address the unsafe condition (i.e., only the RC actions).

Costs of Compliance

    We estimate that this proposed AD affects 451 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                     Labor cost          Parts cost     Cost per product        operators
----------------------------------------------------------------------------------------------------------------
General visual inspection......  Up to 6 work-hours x                 $0  Up to $510........  Up to $230,010.
                                  $85 per hour = up to
                                  $510.
Repetitive DFEC inspections....  Up to 124 work-hours x                0  Up to $10,540 per   Up to $4,753,540
                                  $85 per hour = up to                     inspection cycle.   per inspection
                                  $10,540 per inspection                                       cycle.
                                  cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this proposed
AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes and associated appliances to the
Director of the System Oversight Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2018-0899; Product Identifier
2018-NM-099-AD.

(a) Comments Due Date

    We must receive comments by November 29, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 757-200, -200PF, -
200CB, and -300 series airplanes, certificated in any category, as
identified in Boeing Alert Requirements Bulletin 757-53A0111 RB,
dated May 21, 2018.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by an evaluation by the design approval
holder (DAH) indicating that the inner skin at the lower fastener
row is subject to widespread fatigue damage (WFD). We are issuing
this AD to address scratches that can grow into scratch cracks,
which could interact with multi-site damage (MSD) fastener hole
fatigue cracking. This condition, if not addressed, could result in
accelerated crack growth rate, which could result in reduced
structural integrity of the airplane.

(f) Compliance

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

(g) Required Actions

    Except as specified by paragraph (h) of this AD: At the
applicable times specified in the ``Compliance'' paragraph of Boeing
Alert Requirements Bulletin 757-53A0111 RB, dated May 21, 2018, do
all applicable actions identified in, and in accordance with, the
Accomplishment Instructions of Boeing Alert Requirements Bulletin
757-53A0111 RB, dated May 21, 2018.

    Note 1 to paragraph (g) of this AD:  Guidance for accomplishing
the actions required by this AD can be found in Boeing Alert Service
Bulletin 757-53A0111, dated May 21, 2018, which is referred to in
Boeing Alert Requirements Bulletin 757-53A0111 RB, dated May 21,
2018.

(h) Exceptions to Service Information Specifications

    (1) For purposes of determining compliance with the requirements
of this AD: Where Boeing Alert Requirements Bulletin 757-53A0111 RB,
dated May 21, 2018, uses the phrase ``the original issue date of
Requirements Bulletin 757-53A0111 RB,'' this AD requires using ``the
effective date of this AD.''
    (2) Where Boeing Alert Requirements Bulletin 757-53A0111 RB,
dated May 21, 2018, specifies contacting Boeing for alternative
inspections or repair instructions, this AD requires alternative
inspection or repair before further flight using a method approved
in accordance with the procedures specified in paragraph (i) of this
AD.
    (3) Inspections performed in accordance with Boeing Alert
Requirements Bulletin 757-53A0111 RB, dated May 21, 2018, are not
necessary in areas where existing FAA approved repairs cover the
affected inspection areas; provided the outermost repair doubler
extends a minimum of three rows of fasteners above and below the
original group of lap splice fasteners subject to the inspection.
Damage tolerance inspections specified for existing repairs must
continue. Inspections outside of the repaired boundaries are still
required as specified in Boeing Alert Requirements Bulletin 757-
53A0111 RB, dated May 21, 2018.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles ACO Branch, FAA, has the authority
to approve AMOCs for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your
request to your principal inspector or local Flight Standards
District Office, as appropriate. If sending information directly to
the manager of the certification office, send it to the attention of
the person identified in paragraph (j)(1) of this AD. Information
may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Los Angeles ACO Branch, FAA, to make those findings. To be
approved, the repair method, modification deviation, or alteration
deviation must meet the certification basis of the airplane, and the
approval must specifically refer to this AD.

(j) Related Information

    (1) For more information about this AD, contact David Truong,
Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch,
3960 Paramount Boulevard, Lakewood, CA 90712 4137; phone: 562-627-
5224; fax:<PHONE_NUMBER>; email: [email protected].
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Standards Branch, 2200 South 216th
St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on September 20, 2018.
John P. Piccola,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-21966 Filed 10-12-18; 8:45 am]
BILLING CODE 4910-13-P


revises FEMA's regulations governing the Public Assistance program at
44 CFR 206.203(c) to increase the monetary threshold for when FEMA will
process an application using ``simplified procedures'' to $1,000,000.
For this information collection, the number of annual responses is
decreasing from 449,084 to 431,720, the annual burden hours are
decreasing from 491,533 to 484,189, and the annual cost to respondents
is decreasing from $27,845,344 to $27,090,374. These changes are due to
a decrease in the number of responses for FEMA Forms 009-0-123, 009-0-
124, 009-0-125, 009-0-126, and 009-0-127 and for the number of
respondents for FEMA Form 009-0-111. FEMA requires that recipients of
large projects fill out these supplemental forms to account for the
actual costs for reconciliation purposes. These forms are not required
for small projects. The decrease in the number of large projects as a
result of the increase in the large project threshold means fewer
applicants submitting these forms.
Collection of Information
    Title: PA Program.
    Type of information collection: Revision of a currently approved
collection.
    OMB Number: 1660-0017.
    Forms: FEMA Form 009-0-49 Request for Public Assistance; FEMA Form
009-0-91 Project Worksheet (PW); FEMA Form 009-0-91A Project Worksheet
(PW)--Damage Description and Scope of Work Continuation Sheet; FEMA
Form 009-0-91B Project Worksheet (PW)--Cost Estimate Continuation
Sheet; FEMA Form 009-0-91C Project Worksheet (PW)--Maps and Sketches
Sheet; FEMA Form 009-0-91D Project Worksheet (PW)--Photo Sheet; FEMA
Form 009-0-120 Special Considerations Questions; FEMA Form 009-0-121
PNP Facility Questionnaire; FEMA Form 009-0-123 Force Account Labor
Summary Record; FEMA Form 009-0-124 Materials Summary Record;

FEMA Form 009-0-125 Rented Equipment Summary Record; FEMA Form 009-0-
126 Contract Work Summary Record; FEMA Form 009-0-127 Force Account
Equipment Summary Record; FEMA Form 009-0-128 Applicant's Benefits
Calculation Worksheet; FEMA Form 009-0-111, Quarterly Progress Report;
FEMA Form 009-0-141, FAC-TRAX System.
    Abstract: The information collected is utilized by FEMA to make
determinations for PA grants based on the information supplied by the
respondents.
    Affected Public: State, local, or Tribal Government.
    Estimated Number of Respondents: 1,067.
    Estimated Number of Responses: 431,720.
    Estimated Total Annual Burden Hours: 484,189.
    The table below provides estimates of annualized cost to
respondents for the hour burdens for the collection of information.

                                                  Table 13--Estimated Annualized Burden Hours and Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                    Avg.        Total                     Total
                                                                Number of    responses      Total      burden per     annual        Avg.        annual
        Type of respondent              Form name/form No.     respondents      per       number of     response   burden  (in     hourly     respondent
                                                                             respondent   responses    (in hours)     hours)     wage rate       cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
State, Local or Tribal Government.  FEMA Form 009-0-49,                 56          129        7,224         0.25        1,806       $55.95     $101,046
                                     Request for PA.
State, Local or Tribal Government.  FEMA Form 009-0-91,                 56          840       47,040          1.5       70,560        55.95    3,947,832
                                     Project Worksheet (PW)
                                     and a Request for Time
                                     Extension.
State, Local or Tribal Government.  FEMA Form 009-0-91A                 56          784       43,904          1.5       65,856        55.95    3,684,643
                                     Project Work Sheet (PW)
                                     Damage Description and
                                     Scope of Work.
State, Local or Tribal Government.  FEMA Form 009-0-91B,                56          784       43,904       1.3333       58,537        55.95    3,275,145
                                     Project Worksheet (PW)
                                     Cost Estimate
                                     Continuation Sheet and
                                     Request for additional
                                     funding for Cost
                                     Overruns.
State, Local or Tribal Government.  FEMA Form 009-0-91C                 56          728       40,768          1.5       61,152        55.95    3,421,454
                                     Project Worksheet (PW)
                                     Maps and Sketches Sheet.
State, Local or Tribal Government.  FEMA Form 009-0-91D                 56          728       40,768          1.5       61,152        55.95    3,421,454
                                     Project Worksheet (PW)
                                     Photo Sheet.
State, Local or Tribal Government.  FEMA Form 009-0-120,                56          840       47,040          0.5       23,520        55.95    1,315,944
                                     Special Considerations
                                     Questions/.
State, Local or Tribal Government.  FEMA Form 009-0-128,                56          784       43,904          0.5       21,952        55.95    1,228,214
                                     Applicant's Benefits
                                     Calculation Worksheet/.
State, Local or Tribal Government.  FEMA Form 009-0-121, PNP            56           94        5,264          0.5        2,632        55.95      147,260
                                     Facility Questionnaire.
State, Local or Tribal Government.  FEMA Form 009-0-123,                56           32        1,792          0.5          896        55.95       50,131
                                     Force Account Labor
                                     Summary Record \112\.
State, Local or Tribal Government.  FEMA Form 009-0-124,                56           32        1,792         0.25          448        55.95       25,066
                                     Materials Summary Record/
                                     .
State, Local or Tribal Government.  FEMA Form 009-0-125,                56           32        1,792          0.5          896        55.95       50,131
                                     Rented Equipment Summary
                                     Record.
State, Local or Tribal Government.  FEMA Form 009-0-126,                56           32        1,792          0.5          896        55.95       50,131
                                     Contract Work Summary
                                     Record/.
State, Local or Tribal Government.  FEMA Form 009-0-127,                56           32        1,792         0.25          448        55.95       25,066
                                     Force Account Equipment
                                     Summary Record/.
State, Local or Tribal Government.  State Administrative Plan           56            1           56            8          448        55.95       25,066
                                     and State Plan
                                     Amendments/No Form.
State, Local or Tribal Government.  FEMA Form 009-0-111,                55            4          220          100       22,000        55.95    1,230,900
                                     Quarterly Progress
                                     Report.
State, Local or Tribal Government.  Request for Appeals or              56            9          504            3        1,512        55.95       84,596
                                     Arbitrations &
                                     Recommendation/No Forms.
State, Local or Tribal Government.  Request for Arbitration &            4            5           20            3           60        55.95        3,357
                                     Recommendation resulting
                                     from Hurricanes Katrina
                                     or Rita/No Form.
State, Local or Tribal Government.  FEMA Form 009-0-141, FAC-           56          913       51,128         1.25       63,910        55.95    3,575,765
                                     TRAX System.
State, Local or Tribal Government.  FEMA Template 104-FY-21-            56          911       51,016          0.5       25,508        55.95    1,427,173
                                     100 Equitable COVID-19
                                     Response and Recovery.
                                                              ------------------------------------------------------------------------------------------
    Total.........................  .........................        1,067  ...........      431,720  ...........      484,189  ...........   27,090,374
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: The ``Avg. Hourly Wage Rate'' for each respondent includes a 1.6 multiplier to reflect a fully-loaded wage rate.

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

    \112\ FEMA uses whole numbers for burden estimates in this
table. These estimates do not match the RIA, since at the $1,000,000
threshold, FEMA calculated a total of 1,761 responses for forms 009-
0-123, 009-0-124, 009-0-125, 009-0-126, and 009-0-0127. The number
of respondents would remain the same at 56, while the average number
of responses per respondent would be 31.45 (rounded up to 32 for the
PRA analysis). In the RIA, the total number of responses was
estimated to be 1,761(56 x 31.45).
---------------------------------------------------------------------------

    Estimated Total Annual Respondent Cost: $27,090,374.
    Estimated Respondents' Operation and Maintenance Costs: N/A.
    Estimated Respondents' Capital and Start-Up Costs: N/A.
    Estimated Total Annual Costs to the Federal Government: $1,957,204.
    FEMA calculated the impact on the Information Collection Request if
the maximum threshold were changed from $132,800 to $1,000,000 by
taking the difference in the number of large projects at the $132,800
threshold compared to the $1,000,000 threshold. At the $132,800
threshold, there are

14,334 large projects over 3.1 years. At the $1,000,000 threshold,
there are 3,476 large projects in 3.1 years. FEMA earlier mentions the
10,858 (14,334-3,476) projects that will now be considered small from
these numbers of projects over 3.1 years. Annually, there will be 3,503
(10,858 / 3.1) additional small projects that were formerly large.
    FEMA then calculated the total number of responses for each form at
the $1,000,000 threshold by taking the total number of responses at the
$132,800 threshold and then subtracting 3,503. For FEMA Form 009-0-123,
009-0-124, 009-0-125, 009-0-126, and 009-0-127, FEMA estimates there
will be 1,761 (5,264-3,503) total number of responses for each of these
forms at the $1,000,000 threshold. FEMA then analyzed the data to
determine then number of recipients who would not have at least one
ongoing large project if the maximum threshold were $1,000,000 compared
to those who would at the $132,800 threshold. Over the 3.1-year period,
the number of recipients with at least 1 ongoing large project would
reduce by 1, from 56 to 55, meaning 1 fewer recipient would submit FEMA
Form 009-0-111. The total number of responses to the quarterly form
would reduce by 12.4 (4 responses x 3.1) over the 3.1-year period, or
by approximately 4 responses annually.

F. Privacy Act/E-Government Act

    Under the Privacy Act of 1974, 5 U.S.C. 552a, an agency must
determine whether implementation of a regulation will result in a
system of records. A ``record'' is any item, collection, or grouping of
information about an individual that is maintained by an agency,
including, but not limited to, one's education, financial transactions,
medical history, and criminal or employment history and that contains
one's name, or the identifying number, symbol, or other identifying
particular assigned to the individual, such as a finger or voice print
or a photograph. See 5 U.S.C. 552a(a)(4). A ``system of records'' is a
group of records under the control of an agency from which information
is retrieved by the name of the individual or by some identifying
number, symbol, or other identifying particular assigned to the
individual. An agency cannot disclose any record which is contained in
a system of records except by following specific procedures.
    The E-Government Act of 2002, 44 U.S.C. 3501 note, also requires
specific procedures when an agency takes action to develop or procure
information technology that collects, maintains, or disseminates
information that is in an identifiable form. This Act also applies when
an agency initiates a new collection of information that will be
collected, maintained, or disseminated using information technology if
it includes any information in an identifiable form permitting the
physical or online contacting of a specific individual.
    In accordance with U.S. Department of Homeland Security (DHS)
policy, FEMA has completed a Privacy Threshold Analysis for this rule.
FEMA has determined this rulemaking does not require the development
and publication of a new or modified System of Records Notice (SORN).
The information collected has coverage under an existing Privacy Impact
Assessments (PIA) and an existing SORN:
    DHS/FEMA/PIA-013 Grant Management Programs;
    DHS/FEMA-009 Hazard Mitigation Assistance Grant Programs SORN.
    The rule does not impact the personally identifiable information
(PII) that FEMA currently collects, stores, maintains, or disseminates.
The rulemaking has adequate coverage under the above listed PIA and
SORN.

G. Executive Order 13175, ``Consultation and Coordination With Indian
Tribal Governments''

    Executive Order 13175, ``Consultation and Coordination with Indian
Tribal Governments,'' 65 FR 67249 (Nov. 9, 2000), applies to agency
regulations that have Tribal implications, that is, regulations that
have substantial direct effects on one or more Indian Tribes, on the
relationship between the Federal government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. Under this Executive Order, to the extent
practicable and permitted by law, no agency shall promulgate any
regulation that has Tribal implications, that imposes substantial
direct compliance costs on Indian Tribal governments, and that is not
required by statute, unless funds necessary to pay the direct costs
incurred by the Indian Tribal government or the Tribe in complying with
the regulation are provided by the Federal Government, or the agency
consults with Tribal officials.
    FEMA has reviewed this final rule under Executive Order 13175 and
has determined that it does not have a substantial direct effect on one
or more Indian tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes. This
rule updates the dollar figure related to FEMA's procedures for
handling grants for small and large projects. It is therefore
procedural and will not affect the substantive rights or interests of
Indian Tribal governments.

H. Executive Order 13132, ``Federalism''

    Executive Order 13132, ``Federalism,'' 64 FR 43255 (Aug. 10, 1999),
sets forth principles and criteria that agencies must adhere to in
formulating and implementing policies that have federalism
implications, that is, regulations that have substantial direct effects
on the States, on the relationship between the national government and
the States, or on the distribution of power and responsibilities among
the various levels of government. Federal agencies must closely examine
the statutory authority supporting any action that would limit the
policymaking discretion of the States, and to the extent practicable,
must consult with State and local officials before implementing any
such action.
    FEMA has determined that this rulemaking does not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, and
therefore does not have federalism implications as defined by the
Executive Order.

I. Executive Order 11988, ``Floodplain Management''

    Pursuant to Executive Order 11988, ``Floodplain Management,'' 42 FR
26951 (May 24, 1977), each agency must provide leadership and take
action to reduce the risk of flood loss, to minimize the impact of
floods on human safety, health and welfare, and to restore and preserve
the natural and beneficial values served by floodplains in carrying out
its responsibilities for (1) acquiring, managing, and disposing of
Federal lands and facilities; (2) providing Federally undertaken,
financed, or assisted construction and improvements; and (3) conducting
Federal activities and programs affecting land use, including but not
limited to water and related land resources planning, regulating, and
licensing activities. In carrying out these responsibilities, each
agency must evaluate the potential effects of any actions it may take
in a floodplain; ensure that its planning programs and budget requests
reflect consideration of flood hazards and floodplain management; and
prescribe procedures

to implement the policies and requirements of the Executive Order.
    Before promulgating any regulation, an agency must determine
whether the regulations will affect a floodplain(s), and if so, the
agency must consider alternatives to avoid adverse effects and
incompatible development in the floodplain(s). If the head of the
agency finds that the only practicable alternative consistent with the
law and with the policy set forth in Executive Order 11988 is to
promulgate a regulation that affects a floodplain(s), the agency must,
prior to promulgating the regulation, design or modify the regulation
in order to minimize potential harm to or within the floodplain,
consistent with the agency's floodplain management regulations. It must
also prepare and circulate a notice containing an explanation of why
the action is to be located in the floodplain.
    The purpose of this rule is to update the dollar figure related to
FEMA's procedures for handling grants for small and large projects. In
accordance with 44 CFR part 9, ``Floodplain Management and Protection
of Wetlands,'' FEMA determines that the changes in this rule would not
have an effect on floodplains. When FEMA undertakes specific actions
that may affect floodplain management, FEMA follows the procedures set
forth in 44 CFR part 9 to ensure compliance with this Executive Order.
These procedures include a specific, eight-step process for conducting
floodplain management and wetland reviews. With few exceptions (such as
emergencies) and as set forth in applicable statutes or regulations,
reviews for compliance must be completed before FEMA approves funding
and before work is started. This rule does not change this process.

J. Executive Order 11990, ``Protection of Wetlands''

    Executive Order 11990, ``Protection of Wetlands,'' 42 FR 26961 (May
24, 1977) sets forth that each agency must provide leadership and take
action to minimize the destruction, loss or degradation of wetlands,
and to preserve and enhance the natural and beneficial values of
wetlands in carrying out the agency's responsibilities. These
responsibilities include (1) acquiring, managing, and disposing of
Federal lands and facilities; and (2) providing Federally undertaken,
financed, or assisted construction and improvements; and (3) conducting
Federal activities and programs affecting land use, including but not
limited to water and related land resources planning, regulating, and
licensing activities. Each agency, to the extent permitted by law, must
avoid undertaking or providing assistance for new construction located
in wetlands unless the head of the agency finds (1) that there is no
practicable alternative to such construction, and (2) that the action
includes all practicable measures to minimize harm to wetlands which
may result from such use. In making this finding, the head of the
agency may take into account economic, environmental and other
pertinent factors.
    In carrying out the activities described in Executive Order 11990,
each agency must consider factors relevant to a proposal's effect on
the survival and quality of the wetlands. These include public health,
safety, and welfare, including water supply, quality, recharge and
discharge; pollution; flood and storm hazards; sediment and erosion;
maintenance of natural systems, including conservation and long term
productivity of existing flora and fauna, species and habitat diversity
and stability, hydrologic utility, fish, wildlife, timber, and food and
fiber resources. They also include other uses of wetlands in the public
interest, including recreational, scientific, and cultural uses. The
purpose of this rule is to update the dollar figure related to FEMA's
procedures for handling grants for small and large projects. In
accordance with 44 CFR part 9, ``Floodplain Management and Protection
of Wetlands,'' FEMA determines that the changes in this rule would not
have an effect on wetlands. When FEMA undertakes specific actions that
may affect floodplain management, FEMA follows the procedures set forth
in 44 CFR part 9 to ensure compliance with this Executive Order. These
procedures include a specific, eight-step process for conducting
floodplain management and wetland reviews. With few exceptions (such as
emergencies) and as set forth in applicable statutes or regulations,
reviews for compliance must be completed before FEMA approves funding
and before work is started. This rule does not change this process.

K. Executive Order 12898, ``Environmental Justice''

    Pursuant to Executive Order 12898, ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations,'' 59 FR 7629 (Feb.16, 1994), as amended by Executive Order
12948, 60 FR 6381 (Feb. 1, 1995), FEMA incorporates environmental
justice into its policies and programs. The Executive Order requires
each Federal agency to conduct its programs, policies, and activities
that substantially affect human health or the environment in a manner
that ensures that those programs, policies, and activities do not have
the effect of excluding persons from participation in programs, denying
persons the benefits of programs, or subjecting persons to
discrimination because of race, color, or national origin.
    This rulemaking will not result in disproportionately high or
adverse effects on human health or the environment. The purpose of this
rule is to update the dollar figure related to FEMA's procedures for
handling grants for small and large PA projects. The PA program
provides funding to States, local governments, Tribal governments, and
PNP facilities/organizations to assist them in their emergency response
and disaster response and recovery efforts. The rulemaking will not
have the effect of excluding persons from participation in or denying
persons the benefit of this program, nor will it subject persons to
discrimination because of race, color, or national origin. The PA
program is administered consistent with the nondiscrimination
requirements of 44 CFR 206.11 and section 308 of the Stafford Act, 42
U.S.C. 5151.

L. National Environmental Policy Act of 1969 (NEPA)

    Section 102 of the National Environmental Policy Act of 1969
(NEPA), 83 Stat. 852 (Jan. 1, 1970) (42 U.S.C. 4321 et seq.) requires
Federal agencies to consider the impacts of their major actions on the
quality of the human environment. Each agency can develop categorical
exclusions (CATEXs) to cover major Federal actions that have been
demonstrated to not typically trigger significant impacts to the human
environment individually or cumulatively. If an action does not qualify
for a CATEX and has the potential to significantly affect the
environment, Federal agencies conduct environmental assessments (EAs)
to evaluate those actions. The Council on Environmental Quality's (CEQ)
procedures for implementing NEPA, 40 CFR parts 1500 through 1508,
require Federal agencies to prepare Environmental Impact Statements
(EISs) for major Federal actions significantly affecting the quality of
the human environment. At the end of the EA process, the agency
determines whether to make a Finding of No Significant Impact (FONSI)
or whether to initiate the EIS process. A major federal action may be
categorically excluded under a Federal agency's NEPA procedures and if
there are no extraordinary circumstances. 40 CFR 1507.3, 1508.4. This
rule falls within the scope of the

Department of Homeland Security List of Categorical Exclusion A3(a),
which covers rules of a strictly administrative or procedural nature.
The update to the monetary threshold in this rule will have no
significant effect on the human environment, is categorically excluded
consistent with DHS procedure and NEPA regulations, and no
extraordinary circumstances have been identified. Therefore, this rule
does not require the preparation of either an EA or an EIS as defined
by NEPA. See Department of Homeland Security Instruction Manual 023-01-
001-01, Revision 01, Implementation of the National Environmental
Policy Act, section (V)(B)(2).

M. National Historic Preservation Act

    The National Historic Preservation Act (NHPA) (54 U.S.C. 300101,
formerly 16 U.S.C. 470) was enacted in 1966, with various amendments
throughout the years. Section 106 of the NHPA (54 U.S.C. 306108)
requires Federal agencies to consider the effects of its actions,
referred to as an ``undertaking,'' on any historic property listed, or
eligible for listing, on the National Register. Section 106 requires
the Federal agency to consult with any Federal agencies, State, local,
and Tribal governments, and members of the public who have an interest
in the effects of the undertaking. Section 106 mandates the
consultation process in the early stages of project planning and that
it be completed prior to the approval of expenditure of any Federal
funds for the undertaking. Subpart B of 36 CFR part 800 lays out a
four-step Section 106 process to fulfill this obligation: 1--Initiate
the process (800.3); 2--Identify historic properties (800.4), 3--Assess
adverse effects (800.5), and 4--Resolve adverse effects (800.6).
    This rule updates the Public Assistance monetary threshold for when
FEMA uses the application of simplified procedures for administrative
efficiency. Pursuant to section 106 of the NHPA and its implementing
regulations at 36 CFR part 800, FEMA has determined that this
rulemaking does not have the potential to cause effects to historic
properties. In accordance with 36 CFR 800.3(a)(1), FEMA has no further
obligations under section 106. When FEMA undertakes specific actions
that may affect historic properties, FEMA follows the procedures set
forth in 36 CFR part 800 to ensure compliance with this law. These
procedures include a specific, four-step process for determining
effects to historic properties. With few exceptions (such as
emergencies) and as set forth in applicable statutes or regulations,
reviews for compliance must be completed before FEMA approves funding
and before work is started. This rule does not change this process.

N. Endangered Species Act

    The Endangered Species Act (ESA) mandates that Federal agencies
determine whether their actions may affect listed species and/or their
designated critical habitat (critical habitat has been designated for
some, but not all listed species). Without authorization or exemption
from Federal resource agencies, it is unlawful for any person, whether
government employee or private citizen, to take listed animal species,
or remove, damage, or destroy (among other actions) an endangered plant
species. 16 U.S.C. 1538, 1539.
    To comply with section 7(a)(2) of the ESA, for every action that
FEMA carries out, funds, or authorizes, FEMA must first determine if
listed species and their designated critical habitat are present in the
action area. If species are present in the action area, then FEMA must
make one of the following determinations with respect to the effect of
the action on listed species and critical habitat: (1) No Effect (NE);
(2) May affect, but is not likely to adversely affect (NLAA); or (3)
May affect and is likely to adversely affect (LAA).
    This rule would update the Public Assistance monetary threshold for
when FEMA uses the application of simplified procedures for
administrative efficiency. This rulemaking has been evaluated by FEMA
and due to its administrative nature, FEMA has determined the
rulemaking does not have the potential to affect federally-listed
species or designated critical habitat. As such, FEMA has made a No
Effect determination for this rulemaking. Per the ESA regulations,
notification to, and consultation with, the U.S. Fish and Wildlife
Service and/or the National Marine Fisheries Service are not required
for activities with a No Effect determination. When FEMA undertakes
specific actions that may affect listed species and their designated
critical habitat, FEMA follows the procedures set forth in section
7(a)(2) to ensure compliance with this law. These procedures include a
process for determining the effect of the action on listed species and
critical habitat. The rule does not change this process.

O. Congressional Review of Agency Rulemaking

    Under the Congressional Review of Agency Rulemaking Act (CRA), 5
U.S.C. 801-808, before a rule can take effect, the Federal agency
promulgating the rule must submit to Congress and to the Government
Accountability Office (GAO) a copy of the rule; a concise general
statement relating to the rule, including whether it is a major rule;
the proposed effective date of the rule; a copy of any cost-benefit
analysis; descriptions of the agency's actions under the Regulatory
Flexibility Act and the Unfunded Mandates Reform Act; and any other
information or statements required by relevant executive orders.
    FEMA has sent this final rule to the Congress and to GAO pursuant
to the CRA. The rule is not a ``major rule'' within the meaning of the
CRA. It will not have an annual effect on the economy of $100,000,000
or more; it will not result in a major increase in costs or prices for
consumers, individual industries, Federal, State, or local government
agencies, or geographic regions; and it will not have significant
adverse effects on competition, employment, investment, productivity,
innovation, or on the ability of United States-based enterprises to
compete with foreign-based enterprises in domestic and export markets.

List of Subjects in 44 CFR Part 206

    Administrative practice and procedure, Coastal zone, Community
facilities, Disaster assistance, Fire prevention, Grant programs-
housing and community development, Housing, Insurance,
Intergovernmental relations, Loan programs-housing and community
development, Natural resources, Penalties, and Reporting and
recordkeeping requirements.

    For the reasons stated in the preamble, the Federal Emergency
Management Agency amends 44 CFR part 206 as follows:

PART 206--FEDERAL DISASTER ASSISTANCE

0
1. The authority citation for part 206 continues to read as follows:

    Authority:  Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 through 5207; Homeland Security Act
of 2002, 6 U.S.C. 101 et seq.; Department of Homeland Security
Delegation 9001.1; sec. 1105, Pub. L. 113-2, 127 Stat. 43 (42 U.S.C.
5189a note).

0
2. In Sec.  206.203:
0
a. In paragraphs (c)(1) and (2), remove ``$120,000'' and add in its
place ``$1,000,000'' wherever it appears; and
0
b. Add paragraph (c)(3).
    The addition reads as follows:

Sec.  206.203   Federal grant assistance.

* * * * *

    (c) * * *
    (3) Applicability date. The dollar threshold provided in this
paragraph (c) applies to project worksheets that have not been
obligated as of August 3, 2022 for major disasters and emergencies
declared on or after March 13, 2020.
* * * * *

Deanne B. Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-16555 Filed 8-2-22; 8:45 am]
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[Federal Register Volume 84, Number 239 (Thursday, December 12, 2019)]
[Notices]
[Pages 67947-67948]
[FR Doc No: 2019-26813]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2528]

Determination of Regulatory Review Period for Purposes of Patent
Extension; BRIVIACT ORAL TABLETS, New Drug Application 205836

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for BRIVIACT ORAL TABLETS and
is publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of an application
to the Director of the U.S. Patent and Trademark Office (USPTO),
Department of Commerce, for the extension of a patent which claims that
human drug product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 10, 2020. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 9, 2020.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 10, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 10, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2016-E-2528 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; BRIVIACT ORAL TABLETS.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that, if a patent
is eligible for extension under these acts, the patent may be extended
for a period of up to 5 years so long as the patented item (human drug
product, animal drug product, medical device, food additive, or color
additive) was subject to regulatory review by FDA before the item was
marketed. Under these acts, a product's regulatory review period forms
the basis for determining the amount of extension an applicant may
receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until the drug product ``was approved'' within the meaning of
35 U.S.C. 156. In the case of a drug recommended for controls under the
Controlled Substances Act (CSA), for purposes of patent term extension
the date of approval is the later of the date the application to market
the drug is approved or the date of issuance of the interim final rule
controlling the drug. (See 35 U.S.C. 156(i)). Although only a portion
of a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (for example, half the
testing phase must be subtracted as well as any time that may have
occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a human drug product will
include all of the testing phase and approval phase as specified in 35
U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product BRIVIACT ORAL
TABLETS (brivaracetam) under new drug application (NDA) 205836.
BRIVIACT ORAL TABLETS is indicated for adjunctive therapy in the
treatment of partial-onset seizures in patients 16 years of age and
older with epilepsy. Subsequent to this approval, the USPTO received a
patent term restoration application for BRIVIACT ORAL TABLETS (U.S.
Patent No. 6,911,461) from UCB Biopharma SPRL and the USPTO requested
FDA's assistance in determining the patent's eligibility for patent
term restoration. In a letter dated January 18, 2017, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of BRIVIACT ORAL TABLETS represented the
first permitted commercial marketing or use of the product. Thereafter,
the USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
BRIVIACT ORAL TABLETS is 4,293 days. Of this time, 3,753 days occurred
during the testing phase of the regulatory review period, while 540
days occurred during the approval phase. These periods of time were
derived from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
August 12, 2004. FDA has verified the applicant's claim that the date
the investigational new drug application (IND) became effective was
August 12, 2004. This IND was the first IND submitted for investigation
of this active ingredient.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: November
20, 2014. FDA has verified the applicant's claim that the NDA for
BRIVIACT ORAL TABLETS (NDA 205836) was initially submitted on November
20, 2014.
    3. For a drug recommended for controls under the CSA, the later of
the date the NDA was approved under section 505 of the FD&C Act or the
date of issuance of the interim final rule controlling the drug: May
12, 2016. FDA has verified the applicant's claim that NDA 205836 was
approved on February 18, 2016. FDA has also verified that the date of
issuance of the interim final rule controlling the drug, placing
BRIVIACT ORAL TABLETS (brivaracetam) in schedule V of the CSA as
revised by the Improving Regulatory Transparency for New Medical
Therapies Act, was May 12, 2016.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 5 years of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26813 Filed 12-11-19; 8:45 am]
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[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]
[Page 69622]
[DOCID:fr19no08-62]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[FFP Missouri 21, LLC; Project No. 13202-000]

Notice of Preliminary Permit Applications Accepted for Filing and
Soliciting Comment, Motions To Intervene, and Competing Applications

November 12, 2008.
    On April 22, 2008, FFP Missouri 21, LLC each filed an application,
pursuant to section 4(f) of the Federal Power Act, proposing to study
the feasibility of the Missouri River 21 Project, to be located on the
Missouri River in Saline, Chariton, and Howard Counties, Missouri.
    The proposed Missouri River 21 Project consists of: (1) 9,300
proposed 20 kilowatt Free Flow generating units having a total
installed capacity of 186 megawatts, (2) a proposed transmission line,
and (3) appurtenant facilities. The FFP Missouri 21, LLC, project would
have an average annual generation of 814.68 gigawatt-hours and be sold
to a local utility.
    Applicant Contact: Mr. Dan Irvin, FFP Missouri 21, LLC, 69 Bridge
Street, Manchester, MA 01944, phone<PHONE_NUMBER>.
    FERC Contact: Robert Bell,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http: //www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of Commission's Web site at http: //
www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13202) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-27370 Filed 11-18-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: March 22, 2010 (Volume 75, Number 54)]
[Notices]
[Page 13529-13531]
[DOCID:fr22mr10-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

March 15, 2010.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC10-44-000.
    Applicants: Cresent Ridge, LLC.
    Description: Supplemental Information for Crescent Ridge LLC.
    Filed Date: 03/04/2010.
    Accession Number: 20100304-5045.
    Comment Date: 5 p.m. Eastern Time on Monday, March 22, 2010.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG10-17-000.
    Applicants: Uilk Wind Farm, LLC.
    Description: Self Certification Notice of Uilk Wind Farm, LLC.
    Filed Date: 01/26/2010.
    Accession Number: 20100126-5108.
    Comment Date: 5p.m. Eastern Time on Thursday, March 25, 2010.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER07-682-005.
    Applicants: Entergy Services, Inc.
    Description: Entergy Operating Companies submits compliance filing.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0219.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER07-956-003.
    Applicants: Entergy Services, Inc.
    Description: Entergy Operating Companies submits compliance filing.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0220.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER09-1099-003; ER07-412-004.
    Applicants: Empire Generating Co, LLC; ECP Energy I, LLC.
    Description: Quarterly Report of ECP Energy I, LLC, and Empire
Generating Co, LLC.
    Filed Date: 02/02/2010.
    Accession Number: 20100202-5146.
    Comment Date: 5 p.m. Eastern Time on Monday, April 5, 2010.

    Docket Numbers: ER09-1192-004.
    Applicants: Southwest Power Pool Inc.
    Description: Southwest Power Pool, Inc submits a ministerial filing
to correct bylaws effective date.
    Filed Date: 03/10/2010.
    Accession Number: 20100312-0213.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 31, 2010.

    Docket Numbers: ER10-566-000.
    Applicants: Coso Geothermal Power Holdings, LLC.
    Description: Amendment to Application of Coso Geothermal Power
Holdings, LLC.
    Filed Date: 03/10/2010.
    Accession Number: 20100310-5073.
    Comment Date: 5 p.m. Eastern Time on Monday, March 22, 2010.

    Docket Numbers: ER10-566-000.
    Applicants: Coso Geothermal Power Holdings, LLC.
    Description: Substitute Organizational Chart of Coso Geothermal
Power Holdings, LLC.
    Filed Date: 03/11/2010.
    Accession Number: 20100311-5048.
    Comment Date: 5 p.m. Eastern Time on Monday, March 22, 2010.

    Docket Numbers: ER10-642-001; ER10-643-001; ER10-310-002.
    Applicants: Algonquin Tinker Gen Co.; Algonquin Northern Maine Gen
Co.; Algonquin Energy Services Inc.
    Description: Algonquin Tinker Gen Co. et al. resubmits Substitute
First Revised Sheets No. 4 as Exhibits A and B to FERC Electric Tariff,
Revised Volume No. 1, with revised sheet designations and effective
dates.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0002.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-663-001.
    Applicants: DTE Energy Supply, Inc.
    Description: DTE Energy Supply, Inc supplements its 1/26/2010
Notice of Succession.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0221.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-852-000.
    Applicants: Grays Ferry Cogeneration Partnership.
    Description: Petition of Grays Ferry Cogeneration Partnership for
order accepting market-based rate tariff for

filing and granting waivers and blanket approvals and request for
expedited action.
    Filed Date: 03/10/2010.
    Accession Number: 20100311-0024.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 31, 2010.

    Docket Numbers: ER10-853-000.
    Applicants: Dynamic PL, LLC.
    Description: Petition for Acceptance of Initial Tariff, Waivers and
Blanket Authorization re: Dynamic PL, LLC.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0201.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-854-000.
    Applicants: CornerStone Power Development, LLC.
    Description: CornerStone Power Development, LLC submits Application
for Order Authorizing Market Based Rates, Waivers of Regulations,
Grants of Blanket Approvals, Request for Category 1 Seller Status etc.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0228.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 24, 2010.

    Docket Numbers: ER10-857-000.
    Applicants: Louisville Gas and Electric Company.
    Description: Louisville Gas and Electric Company et al. submits a
Notice of Cancellation of their Automatic Reserve Sharing Energy Sales
Tariff etc. re: FERC Electric Tariff, Original Volume 4.
    Filed Date: 03/11/2010.
    Accession Number: 20100311-0028.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 1, 2010.

    Docket Numbers: ER10-858-000.
    Applicants: LG&E Capital Trimble County LLC.
    Description: LG&E Capital Trimble County, LLC submits a Notice of
Cancellation of its Test Power Sales Tariff etc. re: Rate Schedule FERC
No 1.
    Filed Date: 03/11/2010.
    Accession Number: 20100311-0027.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 1, 2010.

    Docket Numbers: ER10-859-000.
    Applicants: Louisville Gas and Electric Company.
    Description: Louisville Gas and Electric Company submits Notice of
Cancellation of its Power Sales Services Tariff etc. re: FERC Electric
Tariff, First Revised Volume 6.
    Filed Date: 03/11/2010.
    Accession Number: 20100311-0026.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 1, 2010.

    Docket Numbers: ER10-866-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits First Revised Sheet 2875 et al. to its FERC Electric Tariff,
Fourth Revised Volume 1, to be effective 6/1/10.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0202.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-867-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits proposed revisions to its Open Access Transmission, Energy and
Operating Reserve Markets Tariff to amend Schedule 31 etc.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0204.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-868-000.
    Applicants: The Cleveland Electric Illuminating Company.
    Description: The Cleveland Electric Illuminating Company submits
Notice of Cancellation of First Revised Sheet 1 to its FERC Electric
Tariff, Original Volume 2 to be effective 3/31/10.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0205.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-869-000.
    Applicants: Ohio Edison Company.
    Description: Ohio Edison Company et al. submits Notice of
Cancellation of First Revised Sheet 1 to FERC Electric Tariff, First
Revised Volume 2 to be effective 3/21/10.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0206.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-870-000.
    Applicants: The Toledo Edison Company.
    Description: The Toledo Edison Company submits Notices of
Cancellation of FERC Electric Tariff, Original Volume 1 and FERC
Electric Tariff, Original Volume 3.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0207.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-871-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits Transmission System Interconnection
Agreement with Black Hills Power, Inc, to be designated as their Rate
Schedule 658 et al.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0208.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-872-000.
    Applicants: American Electric Power Service Corporation.
    Description: AEP Texas Central Company submits an executed Restated
and Amended Interconnection Agreement with South Texas Electric
Cooperative, Inc.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0209.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-873-000.
    Applicants: Ameren Services Company.
    Description: Union Electric Company submits an executed service
agreement for Wholesale Distribution Service with City of St. James,
Missouri.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0210.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-874-000.
    Applicants: Ameren Services Company.
    Description: Union Electric Company submits an executed service
agreement for Wholesale Distribution Service with Rolla Municipal
Utilities.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0211.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-875-000.
    Applicants: Ameren Services Company.
    Description: Union Electric Company submits an executed Connection
Construction Agreement with Rolla Municipal Utilities.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0212.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-876-000.
    Applicants: Ameren Services Company.
    Description: Union Electric Company submits an executed
Distribution Connection Agreement with Rolla Municipal Utilities et al.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0214.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-877-000.
    Applicants: The Empire District Electric Company.
    Description: The Empire District Electric Company submits its Full
Requirements Electric Service Rate Schedule, including a standard form
of Electric Service Agreement, designated FERC Electric Rate Schedule 4
effective 6/1/10.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0216.

    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-878-000.
    Applicants: Peetz Table Wind Energy, LLC.
    Description: Peetz Table Wind Energy, LLC submits an Amended and
Restated Shared Facilities Agreement with Logan Wind Energy LLC et al.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0217.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-879-000.
    Applicants: Entergy Arkansas Inc.
    Description: Entergy Arkansas, Inc submits the 2010 Wholesale
Formula Rate Update.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0218.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Docket Numbers: ER10-880-000.
    Applicants: Saracen Merchant Energy LP.
    Description: Saracen Merchant Energy, LP submits Notice of
Cancellation of Rate Schedule FERC No. 1.
    Filed Date: 03/12/2010.
    Accession Number: 20100315-0229.
    Comment Date: 5 p.m. Eastern Time on Friday, April 2, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-6211 Filed 3-19-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 71 (Thursday, April 12, 2012)]
[Rules and Regulations]
[Pages 21866-21868]
[FR Doc No: 2012-8757]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-0282]
RIN 1625-AA00

Safety Zone; Sunken Vessel, Puget Sound, Everett, WA

AGENCY: Coast Guard, DHS.

ACTION: Temporary Final rule.

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SUMMARY: The Coast Guard is establishing a safety zone around the Vigor
Marine Dry Dock, located in Everett, WA. This action is necessary to
prevent maritime traffic from colliding with a sunken dry dock and
associated debris, and to ensure the safety of the salvage crews on
scene. It will do so by prohibiting vessels from entering or remaining
in the safety zone unless authorized by the Captain of the Port or his
Designated Representative.

DATES: This rule is effective in the CFR on April 12, 2012 through
11:59 p.m. on April 15, 2012. This rule is effective with actual notice
for purposes of enforcement at 12 a.m. on April 2, 2012. This rule will
remain in effect through 11:59 p.m. on April 15, 2012.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2012-0282 and are available online
by going to http://www.regulations.gov, inserting USCG-2012-0282 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or email ENS Nathaniel P. Clinger, Waterways
Management Division, Coast Guard Sector Puget Sound; Coast Guard;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>If you have
questions on viewing the docket, call Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because publishing a NPRM would be contrary
to public interest since immediate action is necessary to protect
vessels, persons, and salvage crews in Everett, WA, from hazards
created by a sunken dry dock requiring emergency salvage operations.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists
for making this rule effective less than 30 days after publication in
the Federal Register. Normal notice and comment procedures cannot be
followed due to the immediate threat of collision and/or exposure to
hazardous pollutants posed by the sunken vessel

and associated pollution response and salvage operations.

Background and Purpose

    On March 18, 2012 at approximately 12:46 p.m. the floating dry dock
in which the 136 foot TUG INVADER was laying on blocks was found to
have capsized and partially sank. As a result the Coast Guard
established a 100 yard safety zone around the Vigor Marine Dry Dock in
Everett, WA. On March 22, 2012 it was determined that a hard
containment boom must be tied to the existing long log boom in place,
which is outside of the original established safety zone. Due to these
operational requirements this rule establishes a 200 yard safety zone
surrounding the dry dock. As salvage operations continue to recover the
floating dry dock, salvage equipment, which may include cranes and
vessels utilizing dive teams that will require this zone to ensure
safety. Enforcement of this zone will commence at 12 a.m. on April 2,
2012. The safety zone created by this rule is necessary to help ensure
the safety of maritime public and the personnel involved in salvage
operations. It prevents navigation in areas that may contain sunken
obstructions, and debris.

Discussion of Rule

    The Coast Guard is establishing a safety zone encompassing all
waters within 200 yards of Vigor Marine Dry Dock in Everett, WA.
Vessels wishing to enter the zone must request permission for entry by
contacting the Joint Harbor Operation Center at<PHONE_NUMBER> or
Vessel Traffic Service Puget Sound on VHF-FM CH 14. Once permission for
entry is granted vessels must proceed at a minimum speed for safe
navigation.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    Executive Orders 13563, Improving Regulation and Regulatory Review,
and 12866, Regulatory Planning and Review, direct agencies to assess
the costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has not been designated a significant regulatory
action under section 3(f) of Executive Order 12866. Accordingly, the
Office of Management and Budget has not reviewed this regulation under
Executive Order 12866. This rule is not a significant regulatory action
due to being limited in size and duration.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
may be small entities: the owners or operators of vessels intending to
transit the affected waterway during the period mentioned. This safety
zone will not have a significant economic impact on a substantial
number of small entities for the following reason. The zone established
in this rule is limited in size and short in duration.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and

responsibilities between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. An environmental analysis checklist and a
categorical exclusion determination will be available in the docket
where indicated under ADDRESSES.

List of Subjects 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-
295, 116 Stat. 2064; Department of Homeland Security Delegation No.
0170.1

0
2. Add a temporary Sec.  165.T13-213 to read as follows:

Sec.  165.T13-213  Safety Zone; Sunken Vessel, Puget Sound, Everett,
WA.

    (a) Location: The following area is designated as a safety zone:
All waters within 200 yards of the Vigor Marine Dry Dock in Everett,
WA.
    (b) Regulations: In accordance with the general regulations in 33
CFR 165, Subpart C, vessels wishing to enter the zone must request
permission for entry by contacting the Joint Harbor Operation Center at
(206) 217-6001 or Vessel Traffic Service Puget Sound on VHF-FM CH 14.
Once permission for entry is granted vessels must proceed at a minimum
speed for safe navigation.
    (c) Effective Dates and Enforcement Periods: This rule will be
effective and enforced from 12 a.m. on April 2, 2012 through 11:59 p.m.
on April 15, 2012, unless cancelled sooner by the Captain of the Port.

    Dated: March 30, 2012.
S. J. Ferguson,
Captain, U.S. Coast Guard, Captain of the Port, Puget Sound.
[FR Doc. 2012-8757 Filed 4-11-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 75, Number 235 (Wednesday, December 8, 2010)]
[Rules and Regulations]
[Page 76260]
[FR Doc No: 2010-30769]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2010-N-0002]

Implantation or Injectable Dosage Form New Animal Drugs; Flunixin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental abbreviated new
animal drug application (ANADA) filed by Agri Laboratories, Ltd. The
supplemental ANADA provides for use of flunixin meglumine solution by
intravenous injection in lactating dairy cows for control of pyrexia
associated with acute bovine mastitis.

DATES: This rule is effective December 8, 2010.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Agri Laboratories, Ltd., P.O. Box 3103, St.
Joseph, MO 64503, filed a supplement to ANADA 200-061 that provides for
veterinary prescription use of FLU-NIX (flunixin meglumine) Injectable
Solution. The supplemental ANADA provides for use of flunixin meglumine
solution by intravenous injection in lactating dairy cows for control
of pyrexia associated with acute bovine mastitis. The supplemental
application is approved as of September 27, 2010, and the regulations
are amended in 21 CFR 522.970 to reflect the approval.
    A summary of safety and effectiveness data and information
submitted to support approval of this application may be seen in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4
p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 522

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  522.970, revise paragraphs (b), (e)(1)(iii), and (e)(2) to
read as follows:

Sec.  522.970  Flunixin.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for
use as in paragraph (e) of this section.
    (1) See Nos. 000061, 055529, and 061623 for use as in paragraph (e)
of this section.
    (2) See No. 000856 for use as in paragraph (e)(1) of this section.
    (3) See Nos. 057561 and 059130 for use as in paragraphs (e)(1) and
(2) of this section.
* * * * *
    (e) * * *
    (1) * * *
    (iii) Limitations. Do not use in horses intended for human
consumption.
    (2) Cattle--(i) Amounts and indications for use--(A) Administer 1.1
to 2.2 mg/kilogram (kg) (0.5 to 1.0 mg/lb) of body weight per day
intravenously, as a single dose or divided into two doses administered
at 12-hour intervals, for up to 3 days for control of pyrexia
associated with bovine respiratory disease and endotoxemia or for
control of inflammation in endotoxemia.
    (B) Administer 2.2 mg/kg (1.0 mg/lb) of body weight once
intravenously for control of pyrexia associated with acute bovine
mastitis.
    (ii) Limitations. Cattle must not be slaughtered for human
consumption within 4 days of last treatment. Milk that has been taken
during treatment and for 36 hours after the last treatment must not be
used for food. Do not use in dry dairy cows. A withdrawal period has
not been established for use in preruminating calves. Do not use in
calves to be processed for veal.
* * * * *

    Dated: December 1, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-30769 Filed 12-7-10; 8:45 am]
BILLING CODE 4160-01-P