[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Proposed Rules]
[Page 50948-50949]
[DOCID:fr18au10-36]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0606; Airspace Docket No. 10-ACE-8]

Proposed Amendment of Class E Airspace; Kennett, MO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace at Kennett, MO.
Decommissioning of the Kennett non-directional beacon (NDB) at Kennett
Memorial Airport has made this action necessary for the safety and
management of Instrument Flight Rules (IFR) operations at the airport.

DATES: 0901 UTC. Comments must be received on or before October 4,
2010.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2010-0606/Airspace Docket No. 10-
ACE-8, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1-800-647-5527), is on the ground floor of the building at
the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2010-0606/
Airspace Docket No. 10-ACE-8.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://
www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_
amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. An
informal docket may also be examined during normal business hours at
the office of the Central Service Center, 2601 Meacham Blvd, Fort
Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), part 71 by amending Class E airspace extending upward from
700 feet above the surface for standard instrument approach procedures
at Kennett Memorial Airport, Kennett, MO. Airspace reconfiguration to
within a 6.6-mile radius of the airport is necessary due to the
decommissioning of the Kennett NDB and the cancellation of the NDB
approach. Controlled airspace is needed for the safety and management
of IFR operations at the airport.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9T, dated August 27, 2009, and effective September 15, 2009, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend controlled airspace at Kennett Memorial Airport,
Kennett, MO.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for part 71 continues to read as follows:

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9T, Airspace Designations and Reporting Points, signed August 27,
2009, and effective September 15, 2009, is amended as follows:

Paragraph 6005 Class E Airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ACE MO E5 Kennett, MO [Amended]

Kennett Memorial Airport, MO
    (Lat. 36[deg]13'33'' N., long. 90[deg]02'12'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Kennett Memorial Airport.

    Issued in Fort Worth, TX, on August 6, 2010.
Anthony D. Roetzel,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2010-20404 Filed 8-17-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 88 (Tuesday, May 7, 2019)]
[Proposed Rules]
[Pages 19891-19893]
[FR Doc No: 2019-09257]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0255; Product Identifier 2019-NM-018-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Airbus SAS Model A330-200 Freighter series airplanes. This proposed AD
was prompted by reports of cracked flexible hoses of the oxygen crew
and courier distribution system (OCCDS) on A330 freighter airplanes.
This proposed AD would require repetitive detailed inspections,
including functional testing, of the OCCDS and replacement of affected
part(s) if necessary, as specified in an European Aviation Safety
Agency (EASA) AD, which will be incorporated by reference. We are
proposing this AD to address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by June 21, 2019.

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 the incorporation by reference (IBR) material described in the
``Related IBR material under 1 CFR part 51'' section in SUPPLEMENTARY
INFORMATION, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne,
Germany; telephone +49 221 89990 1000; email<EMAIL_ADDRESS>
internet www.easa.europa.eu. You may find this IBR material on the EASA
website at https://ad.easa.europa.eu. You may view this IBR material 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 in the AD docket on the
internet at http://www.regulations.gov.

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-2019-
0255; 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 (telephone 800-
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

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-2019-0255;
Product Identifier 2019-NM-018-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 based on
those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this NPRM.

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0027, dated February 4, 2019
(``EASA AD 2019-0027'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Airbus SAS Model A330-200 Freighter series airplanes.
The MCAI states:

    Several occurrences were reported of finding cracked flexible
hoses [part number] P/N 32209-series of the OCCDS on A330 freighter
aeroplanes. These flexible hoses are steel braided hoses with
polyurethane (PUR) inner tubes and steel inner springs. On A330
freighter aeroplanes, these hoses are located in the courier area
and are not pressurized during normal operation.
    This condition, if not detected and corrected, could lead to
oxygen leakage in the flexible hose of the OCCDS, which, in
combination with in-flight depressurization, smoke in cockpit or
smoke evacuation procedure, could possibly result in cockpit crew
injury and reduced control of the aeroplane.
    To address this potential unsafe condition, Airbus issued the SB
[service bulletin] to provide inspection instructions.
    For the reasons described above, this [EASA] AD requires
repetitive detailed inspections (DET), including functional testing,
of the OCCDS and, depending on findings, replacement of affected
part(s).

Related IBR Material Under 1 CFR Part 51

    EASA AD 2019-0027 describes procedures for repetitive inspections
and replacement of OCCDS flexible hoses. This material 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, and it is publicly available through the EASA
website.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI referenced
above. We are proposing this AD because we evaluated all pertinent
information and determined an unsafe condition exists and is likely to
exist or develop on other products of the same type design.

Proposed Requirements of This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2019-0027 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA worked with Airbus and EASA to develop a process to
use certain EASA ADs as the primary source of information for
compliance with requirements for corresponding FAA ADs. As a result,
EASA AD 2019-0027 will be incorporated by reference in the FAA final
rule. This proposed AD would, therefore, require compliance with the
provisions specified in EASA AD 2019-0027, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Service information specified in EASA AD 2019-0027 that is required for
compliance with EASA AD 2019-0027 will be available on the internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2019-0255 after the FAA final rule is published.

Costs of Compliance

    We estimate that this proposed AD affects 5 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on  U.S.
                           Labor cost                               Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
14 work-hours x $85 per hour = $1,190...........................              $0          $1,190          $5,950
----------------------------------------------------------------------------------------------------------------

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

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This 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):

Airbus SAS: Docket No. FAA-2019-0255; Product Identifier 2019-NM-
018-AD.

(a) Comments Due Date

    We must receive comments by June 21, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus SAS Model A330-223F and -243F
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 35, Oxygen.

(e) Reason

    This AD was prompted by reports of cracked flexible hoses of the
oxygen crew and courier distribution system (OCCDS) on A330
freighter airplanes. We are issuing this AD to address cracked
oxygen hoses. This condition, if not addressed, could lead to oxygen
leakage in the flexible hose of the OCCDS, which, in combination
with in-flight depressurization, smoke in the flight deck, or a
smoke evacuation procedure, could result in crew injury and reduced
control of the airplane.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Aviation Safety Agency (EASA) AD 2019-
0027, dated February 4, 2019 (``EASA AD 2019-0027'').

(h) Exceptions to EASA AD 2019-0027

    (1) For purposes of determining compliance with the requirements
of this AD: Where EASA AD 2019-0027 refers to its effective date,
this AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2019-0027 does not apply
to this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards 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 International Section, send it to the attention of
the person identified in paragraph (j)(2) of this AD. Information
may be emailed to<EMAIL_ADDRESS>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.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2019-0027 that contains RC procedures and
tests: Except as required by paragraph (i)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(j) Related Information

    (1) For information about EASA AD 2019-0027, contact EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
89990 6017; email<EMAIL_ADDRESS>Internet www.easa.europa.eu.
You may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this EASA AD 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
206-231-3195. EASA AD 2019-0027 may be found in the AD docket on the
internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2019-0255.
    (2) For more information about this AD, contact Vladimir
Ulyanov, Aerospace Engineer, International Section, Transport
Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on April 25, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-09257 Filed 5-6-19; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54103-54104]
[FR Doc No: 2018-23441]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC19-14-000.
    Applicants: Fawkes Holdings, LLC, Wheelabrator Technologies Inc.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act, et al. of Wheelabrator Technologies Inc., et
al.
    Filed Date: 10/19/18.
    Accession Number: 20181019-5233.
    Comments Due: 5 p.m. ET 11/9/18.

    Docket Numbers: EC19-15-000.
    Applicants: Bishop Hill Energy III LLC, Bishop Hill Interconnection
LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act, et al. of Bishop Hill Energy III LLC, et al.
    Filed Date: 10/19/18.
    Accession Number: 20181019-5235.
    Comments Due: 5 p.m. ET 11/9/18.

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

    Docket Numbers: ER16-1609-002.
    Applicants: ID SOLAR 1, LLC.
    Description: Compliance filing: ID Solar 1 Notice of Change in
Status to be effective 10/23/2018.
    Filed Date: 10/22/18.
    Accession Number: 20181022-5097.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER18-2339-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment: 2018-10-22_SA 3152 Polaris Wind
Energy-METC GIA (J533) Substitute Original to be effective 8/15/2018.
    Filed Date: 10/22/18.
    Accession Number: 20181022-5077.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-150-000.
    Applicants: MidAmerican Energy Company.
    Description: Sec.  205(d) Rate Filing: Concurrence filing for
Prairie Wind Remote LBA Gen. Interchange Agt. to be effective 10/15/
2018.
    Filed Date: 10/19/18.
    Accession Number: 20181019-5157.
    Comments Due: 5 p.m. ET 11/9/18.

    Docket Numbers: ER19-151-000.
    Applicants: MATL LLP.
    Description: Sec.  205(d) Rate Filing: Open Solicitation Filing to
be effective 10/23/2018.
    Filed Date: 10/22/18.
    Accession Number: 20181022-5039.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-152-000.
    Applicants: Arizona Public Service Company.
    Description: Notice of Cancellation of Transmission Service
Agreement No. 132 of Arizona Public Service Company.
    Filed Date: 10/19/18.
    Accession Number: 20181019-5239.
    Comments Due: 5 p.m. ET 11/9/18.

    Docket Numbers: ER19-153-000.
    Applicants: Alabama Power Company.
    Description: Sec.  205(d) Rate Filing: Cooperative Energy NITSA
Amendment (Remove West Hattiesburg DP) to be effective 10/1/2018.
    Filed Date: 10/22/18.
    Accession Number: 20181022-5136.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-154-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: Agreement for
Interconnection of the Harry Allen to Eldorado 500kV Line to be
effective 10/23/2018.
    Filed Date: 10/22/18.
    Accession Number: 20181022-5137.
    Comments Due: 5 p.m. ET 11/13/18.

    Docket Numbers: ER19-155-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Sec.  205(d) Rate Filing: DEC-DEP As-Available
Capacity Agreement to be effective 12/22/2018.
    Filed Date: 10/22/18.
    Accession Number: 20181022-5144.
    Comments Due: 5 p.m. ET 11/13/18.

    Take notice that the Commission received the following qualifying
facility filings:
    Docket Numbers: QF19-129-000.
    Applicants: Flint Hills Resources Pine Bend, LLC.
    Description: Form 556 of Flint Hills Resources Pine Bend, LLC.
    Filed Date: 10/12/18.
    Accession Number: 20181012-5240.
    Comments Due: None-Applicable.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 22, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-23441 Filed 10-25-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)]
[Notices]
[Pages 55623-55625]
[FR Doc No: 2017-25316]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2017-0002; Internal Agency Docket No. FEMA-B-1760]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in

accordance with Title 44, Part 65 of the Code of Federal Regulations
(44 CFR part 65). The LOMR will be used by insurance agents and others
to calculate appropriate flood insurance premium rates for new
buildings and the contents of those buildings. For rating purposes, the
currently effective community number is shown in the table below and
must be used for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: November 2, 2017.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Chief executive                         Online location of
        State and county          Location and case      officer of         Community map        letter  of map            Date of         Community no.
                                         no.              community          repository             revision            modification
--------------------------------------------------------------------------------------------------------------------------------------------------------
Arizona:
    Maricopa...................  City of Avondale    The Honorable Kenn  Development &       https://msc.fema.gov/  Jan. 26, 2018.......          040038
                                  (17-09-1266P).      Weise, Mayor,       Engineering         portal/advanceSearch.
                                                      City of Avondale,   Services
                                                      11465 West Civic    Department, 11465
                                                      Center Drive,       West Civic Center
                                                      Avondale, AZ        Drive, Avondale,
                                                      85323.              AZ 85323.

    Maricopa...................  City of Scottsdale  The Honorable W.J.  Planning Records,   https://msc.fema.gov/  Jan. 26, 2018.......          045012
                                  (17-09-0349P).      ``Jim'' Lane,       7447 East Indian    portal/advanceSearch.
                                                      Mayor, City of      School Road,
                                                      Scottsdale, City    Suite 100,
                                                      Hall, 3939 North    Scottsdale, AZ
                                                      Drinkwater          85251.
                                                      Boulevard,
                                                      Scottsdale, AZ
                                                      85251.
    Maricopa...................  Town of Paradise    The Honorable       Town Hall, 6401     https://msc.fema.gov/  Jan. 26, 2018.......          040049
                                  Valley (17-09-      Michael Collins,    East Lincoln        portal/advanceSearch.
                                  0349P).             Mayor, Town of      Drive, Paradise
                                                      Paradise Valley,    Valley, AZ 85253.
                                                      6401 East Lincoln
                                                      Drive, Paradise
                                                      Valley, AZ 85253.
    Maricopa...................  Unincorporated      The Honorable       Flood Control       https://msc.fema.gov/  Jan. 26, 2018.......          040037
                                  Areas of Maricopa   Denny Barney,       District of         portal/advanceSearch.
                                  County (17-09-      Chairman, Board     Maricopa County,
                                  1266P).             of Supervisors,     2801 West Durango
                                                      Maricopa County,    Street, Phoenix,
                                                      301 West            AZ 85009.
                                                      Jefferson Street,
                                                      10th Floor
                                                      Phoenix, AZ 85003.
California:
    Los Angeles................  City of Calabasas   The Honorable Mary  City Hall, 100      https://msc.fema.gov/  Feb. 5, 2018........          060749
                                  (17-09-0821P).      Sue Maurer,         Civic Center Way,   portal/advanceSearch.
                                                      Mayor, City of      Calabasas, CA
                                                      Calabasas, 100      91302.
                                                      Civic Center Way,
                                                      Calabasas, CA
                                                      91302.

    Napa.......................  Unincorporated      The Honorable       Napa County Public  https://msc.fema.gov/  Feb. 9, 2018........          060205
                                  Areas of Napa       Belia Ramos,        Works Department,   portal/advanceSearch.
                                  County (17-09-      Chair, Board of     1195 3rd Street,
                                  0456P).             Supervisors, Napa   Suite 201, Napa,
                                                      County, 1195 3rd    CA 94559.
                                                      Street, Suite
                                                      310, Napa, CA
                                                      94559.
    Riverside..................  City of Corona (17- The Honorable Dick  City Hall, 400      https://msc.fema.gov/  Feb. 1, 2018........          060250
                                  09-1498P).          Haley, Mayor,       South Vicentia      portal/advanceSearch.
                                                      City of Corona,     Avenue, Corona,
                                                      400 South           CA 92882.
                                                      Vicentia Avenue,
                                                      Corona, CA 92882.
Illinois: Madison                City of Wood River  The Honorable       City Hall, 111      https://msc.fema.gov/  Feb. 9, 2018........          170451
                                  (17-05-1811P).      Cheryl Maguire,     North Wood River    portal/advanceSearch.
                                                      Mayor, City of      Avenue, Wood
                                                      Wood River, 111     River, IL 62095.
                                                      North Wood River
                                                      Avenue, Wood
                                                      River, IL 62095.
Iowa: Polk                       Unincorporated      Councilman Robert   Polk County         https://msc.fema.gov/  Jan. 16, 2018.......          190901
                                  Areas of Polk       Brownell            Planning            portal/advanceSearch.
                                  County (17-07-      Counselor, Polk     Division, 5885
                                  0912P).             County, District    Northeast 14th
                                                      1, Polk County      Street, Des
                                                      Administration      Moines, IA 50313.
                                                      Building, 111
                                                      Court Avenue,
                                                      Suite 300, Des
                                                      Moines, IA 50309.
Minnesota: Stearns               City of Melrose     The Honorable Joe   Administration      https://msc.fema.gov/  Jan. 18, 2018.......          270450
                                  (17-05-3040P).      Finken, Mayor,      Office, 225 East    portal/advanceSearch.
                                                      City of Melrose,    1st Street
                                                      225 1st Street      Northeast,
                                                      Northeast,          Melrose, MN 56352.
                                                      Melrose, MN 56352.
Missouri: St. Charles            City of Saint       The Honorable Len   City Hall, 1 Saint  https://msc.fema.gov/  Jan. 18, 2018.......          290319
                                  Peters (17-07-      Pagano, Mayor,      Peters Centre       portal/advanceSearch.
                                  0905P).             City of Saint       Boulevard, Saint
                                                      Peters, 1 Saint     Peters, MO 63376.
                                                      Peters Centre
                                                      Boulevard, St.
                                                      Peters, MO 63376.
Wisconsin: Milwaukee             Village of          The Honorable       Village Hall 6500   https://msc.fema.gov/  Jan. 19, 2018.......          550276
                                  Greendale (17-05-   James Birmingham,   Northway Street,    portal/advanceSearch.
                                  5076P).             President,          Greendale, WI
                                                      Village of          53129.
                                                      Greendale, 6500
                                                      Northway Street,
                                                      Greendale, WI
                                                      53129.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2017-25316 Filed 11-21-17; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Rules and Regulations]
[Pages 19033-19036]
[FR Doc No: 2016-07523]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 56

[Docket No. FDA-2015-N-5052]

Administrative Actions for Noncompliance; Lesser Administrative
Actions

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the
regulation describing lesser administrative actions that may be imposed
on an Institutional Review Board (IRB) that has failed to comply with
FDA's IRB regulations. We are clarifying that FDA may require the IRB
to withhold approval of new FDA-regulated studies, stop the enrollment
of new subjects in ongoing studies, and terminate ongoing studies, or
any combination of these actions until the noncompliance with FDA's IRB
regulations is corrected. We are taking this action to ensure clarity
and improve the accuracy of the regulations.

DATES: This rule is effective August 17, 2016. Submit electronic or
written comments on this direct final rule or its companion proposed
rule by June 20, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2015-N-5052 for ``Subpart E--Administrative Actions for
Noncompliance; Lesser Administrative Actions.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets
Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sheila Brown, Office of Good Clinical
Practice, Office of Special Medical Programs, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is amending Sec.  56.120(b) (21 CFR 56.120(b)), which describes
lesser administrative actions that the Agency may impose on an IRB
until the IRB takes appropriate action to correct the IRB's
noncompliance. We are publishing this direct final rule because it is
intended to clarify an existing regulation, and we do not anticipate
any significant adverse comment regarding this amendment to Sec.
56.120(b). Specifically, this direct final rule would amend Sec.
56.120(b) by clarifying that FDA has authority to require the IRB to
withhold approval of new FDA-regulated studies conducted at the
institution or reviewed by the IRB, direct that no new subjects be
added to ongoing studies, and terminate ongoing studies provided that
doing so would not endanger study subjects.
    This amendment also renumbers current paragraphs (b)(4) and (c) as
paragraphs (c) and (d), respectively, and inserts ``FDA may'' into
newly designated paragraph (c) so that it is a complete sentence.
    FDA first proposed requirements for the composition and operations
of institutional review committees in the ``Proposed Investigational
Device Exemptions,'' published in the Federal Register of August 20,
1976 (41 FR 35282; ``Proposed IDE Rule''). In that document, FDA
proposed disqualification procedures for institutional review
committees and requested comments on the proposed procedures and other
possible administrative actions that FDA might take against a committee
that is not in compliance with the regulations (41 FR 35282 at 35293).
FDA also stated its intention to publish uniform, Agency-wide
regulations governing clinical investigations at a later date,
including requirements governing institutional review committees (41 FR
35282 at 35283).
    Subsequently, FDA published ``Standards for Institutional Review
Boards for Clinical Investigations'' on August 8, 1978 (43 FR 35186;
``Proposed IRB Standards''). Comments on implementing institutional
review requirements received in response to the Proposed IDE Rule were
reviewed and utilized in preparing the Proposed IRB Standards (43 FR
35186 at 35187). In the Proposed IRB Standards, FDA proposed that
disqualification would be used only if the Commissioner of Food and
Drugs finds that: (1) The IRB failed to comply with one or more of the
standards for IRBs in part 56 or other supplemental requirements in the
investigational new drug or investigational device exemptions (IDE)
regulations; (2) the noncompliance adversely affects the validity of
the data or the rights or safety of the human subjects; and (3) other
lesser regulatory actions (e.g., warnings or rejection of data from
individual clinical investigations) have not been or probably will not
be adequate in achieving compliance (43 FR 35186 at 35195).
    FDA received numerous comments to the Proposed IRB Standards, and
addressed those comments in the Federal Register of January 27, 1981
(46 FR 8958), ``Protection of Human Subjects: Standards for
Institutional Review Boards for Clinical Investigations, Final Rule.''
Specifically, several comments suggested that any lesser regulatory
actions should be listed (46 FR 8958 at 8973). FDA accepted these
comments and revised Sec.  56.120(b) to set forth the lesser
administrative actions that the Agency may take if FDA finds
deficiencies in the operation of an IRB and to describe the
circumstances in which these lesser administrative actions may be used
by the Agency. FDA's longstanding interpretation of Sec.  56.120(b) is
that FDA may impose these restrictions on a noncompliant IRB until the
IRB takes appropriate corrective action. The text of the regulation,
however, suggests that it is the Agency that would withhold approval of
studies that have been reviewed by a noncompliant IRB, rather than
authorizing FDA to direct the IRB to stop approving new studies until
the IRB comes back into compliance.
    This direct final rule amends Sec.  56.120(b) to read, in addition,
until the IRB or the parent institution takes appropriate corrective
action, the Agency may require the IRB to withhold approval of new
studies, direct that no new subjects be added to ongoing studies, or
terminate ongoing studies. This will ensure that those activities are
suspended until the IRB takes appropriate corrective action to address
its noncompliance. We believe revising Sec.  56.120(b) as described in
this document will improve the clarity and accuracy of the regulations.
We are also renumbering Sec.  56.120(b)(4) as Sec.  56.120(c), and
Sec.  56.120(c) as Sec.  56.120(d). We are inserting ``FDA may'' into
newly designated Sec.  56.120(c) so that it is a complete sentence.
    FDA may notify relevant State and Federal regulatory Agencies when
warranted to assure that organizations with a need to know about the
IRB's apparent noncompliance are appropriately informed. The revision
would eliminate confusion by stating clearly that FDA is authorized to
notify others about the IRB's noncompliance. We believe these changes
will ensure clarity and improve the accuracy of the regulations.

II. Procedures for Issuing a Direct Final Rule

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA
announced the availability of the guidance document entitled ``Guidance
for FDA and Industry: Direct Final Rule Procedures'' \1\ that described
when and how we will employ direct final rulemaking. We believe that
this rule is

appropriate for direct final rulemaking because it is intended to
clarify an existing regulation. We anticipate no significant adverse
comment.
---------------------------------------------------------------------------

    \1\ http://www.fda.gov/regulatoryinformation/guidances/ucm125166.htm.
---------------------------------------------------------------------------

    Consistent with FDA's direct final rulemaking procedures, we are
publishing a companion proposed rule elsewhere in this issue of the
Federal Register. That proposed rule is identical in substance to this
direct final rule. The companion proposed rule will serve the purpose
of issuing a proposed rule under usual notice-and-comment procedures in
the event we withdraw this direct final rule because we receive
significant adverse comment. The comment period for this direct final
rule runs concurrently with the comment period of the companion
proposed rule. We will consider any comments that we receive in
response to the companion proposed rule to be comments also regarding
this direct final rule and vice versa.
    If FDA receives any significant adverse comment, we will withdraw
this direct final rule before its effective date by publishing a notice
in the Federal Register within 30 days after the comment period ends. A
significant adverse comment is one that explains why the rule would be
inappropriate (including challenges to the rule's underlying premise or
approach), or would be ineffective or unacceptable without a change. In
determining whether an adverse comment is significant and warrants
withdrawing a direct final rule, we consider whether the comment raises
an issue serious enough to warrant a substantive response in a notice-
and-comment process in accordance with section 553 of the
Administrative Procedure Act (APA) (5 U.S.C. 553). Comments that are
frivolous, insubstantial, or outside the scope of the rule would not be
considered adverse. A comment recommending a rule change in addition to
the rule would not be considered a significant adverse comment, unless
the comment states why the rule would be ineffective without the
additional change. In addition, if a significant adverse comment
applies to part of a rule and that part can be severed from the
remainder of the rule, we may adopt as final those parts of the rule
that are not the subject of a significant adverse comment.
    If we withdraw this direct final rule, FDA will consider all
comments that we received regarding the companion proposed rule as we
develop a final rule through the usual notice-and-comment procedures of
the APA. If we receive no significant adverse comment during the
specified comment period regarding this direct final rule, we intend to
publish a confirmation notice in the Federal Register within 30 days
after the comment period ends.

III. Legal Authority

    This rule, if finalized, would amend Sec.  56.120(b). FDA's
authority to modify Sec.  56.120(b) arises from the same authority
under which FDA initially issued this regulation, the IRB regulations,
and general administrative provisions of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352,
353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e,
381; 42 U.S.C. 216, 241, 262).

IV. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) and 25.34(a) 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.

V. Economic Analysis of Impact

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
believe that this final rule is not a significant regulatory action as
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this rule does not add any additional regulatory
burdens, we certify that this final rule will not have a significant
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $144
million, using the most current (2014) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
    The purpose of this final rule is to affirm FDA's longstanding
interpretation of Sec.  56.120(b), that FDA may impose these
administrative actions on a noncompliant IRB until the IRB takes
appropriate corrective action. The amendment will improve the clarity
and accuracy of the regulations. Because this final rule is a
clarification and would impose no additional regulatory burdens, this
regulation is not anticipated to result in any compliance costs, and
the economic impact is expected to be minimal.

VI. Paperwork Reduction Act of 1995

    This direct final rule contains no collection of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is not required.

VII. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies 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. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive Order and, consequently, a
federalism summary impact statement is not required.

List of Subjects in 21 CFR Part 56

    Human research subjects, Reporting and recordkeeping requirements,
Safety.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
56 is amended as follows:

PART 56--INSTITUTIONAL REVIEW BOARDS

0
1. The authority citation for 21 CFR part 56 is revised to read as
follows:

    Authority: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351,
352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371,
379e, 381; 42 U.S.C. 216, 241, 262.

0
2. In Sec.  56.120, redesignate paragraphs (b)(4) and (c) as paragraphs
(c) and (d), respectively, and revise paragraph (b) and newly
designated paragraph (c) to read as follows:

Sec.  56.120  Lesser administrative actions.

* * * * *
    (b) On the basis of the IRB's or the institution's response, FDA
may schedule a reinspection to confirm the adequacy of corrective
actions. In addition, until the IRB or the parent institution takes
appropriate corrective action, the Agency may require the IRB to:
    (1) Withhold approval of new studies subject to the requirements of
this part that are conducted at the institution or reviewed by the IRB;
    (2) Direct that no new subjects be added to ongoing studies subject
to this part; or
    (3) Terminate ongoing studies subject to this part when doing so
would not endanger the subjects.
    (c) When the apparent noncompliance creates a significant threat to
the rights and welfare of human subjects, FDA may notify relevant State
and Federal regulatory agencies and other parties with a direct
interest in the Agency's action of the deficiencies in the operation of
the IRB.
* * * * *

    Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07523 Filed 4-1-16; 8:45 am]
 BILLING CODE 4164-01-P