[Federal Register Volume 87, Number 104 (Tuesday, May 31, 2022)]
[Notices]
[Page 32425]
[FR Doc No: 2022-11631]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0887]

TG Therapeutics, Inc.; Withdrawal of Approval of New Drug
Application for UKONIQ (Umbralisib Tosylate) Tablets, Equivalent to 200
Milligrams Base

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of the new drug application (NDA) for UKONIQ
(umbralisib tosylate) Tablets, equivalent to (EQ) 200 milligrams (mg)
Base, held by TG Therapeutics, Inc., 3020 Carrington Mill Blvd.,
Morrisville, NC 27560. TG Therapeutics, Inc. (TGT) has voluntarily
requested that FDA withdraw approval of this application and has waived
its opportunity for a hearing.

DATES: Approval is withdrawn as of May 31, 2022.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].

SUPPLEMENTARY INFORMATION: On February 5, 2021, FDA approved NDA 213176
for UKONIQ (umbralisib tosylate) Tablets, EQ 200 mg base, for the
treatment of adult patients with: (1) Relapsed or refractory marginal
zone lymphoma (MZL) who have received at least one prior anti-CD20-
based regimen and (2) relapsed or refractory follicular lymphoma (FL)
who have received at least three prior lines of systemic therapy, under
the Agency's accelerated approval regulations, 21 CFR part 314, subpart
H. The accelerated approval of UKONIQ (umbralisib tosylate) Tablets, EQ
200 mg base, for MZL and FL included required postmarketing trials
intended to verify the clinical benefit of UKONIQ.
    On February 3, 2022, FDA issued a Drug Safety Communication about a
possible increased risk of death with UKONIQ (umbralisib tosylate)
Tablets, EQ 200 mg base. FDA's initial review of data from a phase 3,
randomized, controlled clinical trial in patients with chronic
lymphocytic leukemia (CLL) who were administered UKONIQ (umbralisib
tosylate) Tablets, EQ 200 mg base, in combination with a monoclonal
antibody drug compared to the control arm showed a possible increased
risk of death in patients receiving the combination of UKONIQ
(umbralisib tosylate) Tablets, EQ 200 mg base, and the monoclonal
antibody (UNITY-CLL trial). Those patients receiving the combination
also experienced more serious adverse events than those in the control
arm. FDA considered the data from the UNITY-CLL trial conducted in
patients with CLL to have implications for UKONIQ's approved uses for
MZL and FL.
    On March 10, 2022 (87 FR 13736), FDA published the Federal Register
notice ``Oncologic Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments,'' announcing
that UKONIQ (umbralisib tosylate) Tablets, EQ 200 mg base, would be
discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting
scheduled for April 22, 2022.
    FDA met with TGT on April 14, 2022, to discuss voluntary withdrawal
of UKONIQ (umbralisib tosylate) Tablets, EQ 200 mg base, pursuant to
Sec.  314.150(d) (21 CFR 314.150(d)) due to the decrement in overall
survival and increased serious adverse events observed with UKONIQ
(umbralisib tosylate) Tablets, EQ 200 mg base, in the UNITY-CLL trial.
FDA recommended the applicant voluntarily request withdrawal of
approval of UKONIQ (umbralisib tosylate) Tablets, EQ 200 mg base, for
the follicular lymphoma and marginal zone lymphoma indications pursuant
to Sec.  314.150(d) and requested TGT waive its opportunity for a
hearing.
    On April 15, 2022, TGT submitted a letter asking FDA to withdraw
approval of NDA 213176 for UKONIQ (umbralisib tosylate) Tablets, EQ 200
mg base, pursuant to Sec.  314.150(d) and waiving its opportunity for a
hearing. On April 18, 2022, FDA acknowledged TGT's request for
withdrawal of approval of the NDA and waiver of its opportunity for a
hearing. FDA also cancelled the ODAC meeting scheduled for April 22,
2022, because the meeting was unnecessary considering the applicant's
withdrawal request.
    For the reasons discussed above, and in accordance with the
applicant's request, approval of NDA 213176 for UKONIQ (umbralisib
tosylate) Tablets, EQ 200 mg base, and all amendments and supplements
thereto, is withdrawn under Sec.  314.150(d). Distribution of UKONIQ
(umbralisib tosylate) Tablets, EQ 200 mg base, into interstate commerce
without an approved application is illegal and subject to regulatory
action (see sections 505(a) and 301(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(a) and 331(d)).

    Dated: May 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11631 Filed 5-27-22; 8:45 am]
BILLING CODE 4164-01-P


Panel Members for the Meeting of the Federal Insecticide, Fungicide and Rodenticide Act Scientific Advisory Panel (FIFRA SAP)

           to Consider and Review Scientific Issues Associated with
Prioritizing the Universe of Endocrine Disruptor Screening Program (EDSP) Chemicals Using Computational Toxicology Tools

                          January 29-February 1, 2013

Docket Number: EPA-HQ-OPP-2012-0818			OPP Docket Tel:<PHONE_NUMBER>

FIFRA SAP Chair

Daniel Schlenk, Ph.D.
Professor of Aquatic Ecotoxicology & Environmental Toxicology
Department of Environmental Sciences
University of California, Riverside
Riverside, CA

Designated Federal Official

Sharlene R. Matten, Ph.D.
U.S.  Environmental Protection Agency
Office of Science Coordination & Policy
FIFRA Scientific Advisory Panel
EPA East Building, MC 7201M
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Tel:<PHONE_NUMBER>, E-mail<EMAIL_ADDRESS>
FIFRA Scientific Advisory Panel Members

Marion F. Ehrich, Ph.D., D.A.B.T., A.T.S.
Professor of Pharmacology and Toxicology
Department of Biomedical Science and Pathobiology
Virginia-Maryland Regional College of Veterinary Medicine
Virginia Polytechnic Institute and State University
Blacksburg, VA

Stephen J. Klaine, Ph.D.
Professor and Director
Clemson University Institute of Environmental Toxicology
Department of Biological Sciences
Pendleton, SC

James L. McManaman, Ph.D.
Professor and Chief
Section of Basic Reproductive Sciences
Departments of Obstetrics and Gynecology & Physiology and Biophysics
University of Colorado-Denver
Aurora, CO

Prakash Nagarkatti, Ph.D.
Vice President for Research
Carolina Distinguished Professor
University of South Carolina
Columbia, SC

Martha S. Sandy, Ph.D.
Senior Toxicologist and Chief
Cancer Toxicology and Epidemiology Section
Reproductive & Cancer Hazard Assessment Branch
Office of Environmental Health Hazard Assessment
California Environmental Protection Agency
Oakland, CA

FQPA Science Review Board Members
Thomas P. Burris, Ph.D., F.A.H.A., F.A.A.A.S.
Professor
Departments of Molecular Therapeutics & Metabolism and Aging
Director, Center for Diabetes and Metabolic Diseases
The Scripps Research Institute
Jupiter, FL

Janice E. Chambers, Ph.D., D.A.B.T., A.T.S.
William L. Giles Distinguished Professor
Director, Center for Environmental Health Sciences
College of Veterinary Medicine
Mississippi State University
Mississippi State, MS

Mark T. D. Cronin, Ph.D.
Professor of Predictive Toxicology
School of Pharmacy and Biomolecular Sciences
Liverpool John Moores University
Liverpool, England UNITED KINGDOM

Nancy Derrick Denslow, Ph.D.
Professor
Department of Physiological Sciences
University of Florida
Gainesville, FL

Miriam N. Jacobs, Ph.D.
Scientific Officer
European Food Safety Authority (EFSA)
Assessment Methodology Unit
Parma, ITALY

Michael J. Keiser, Ph.D.
President & Chief Operating Officer
SeaChange Pharmaceuticals, Inc.
San Francisco, CA

M.E. (Bette) Meek, Ph.D.
Associate Director
Chemical Risk Assessment
McLaughlin Centre for Population Health Risk Assessment
University of Ottawa
Ottawa, Ontario CANADA

Edward J. Perkins, Ph.D.
Senior Research Scientist (ST)
Environmental Networks and Genetic Toxicology
Environmental Laboratory
U.S. Army Engineer Research and Development Center
U.S. Army Corps Engineers
Vicksburg, MS

Stephen H. Safe, Ph.D.
Distinguished Professor
Department of Veterinary Physiology and Pharmacology
Texas A&M University
College Station, TX

Terry Schultz, Ph.D.
Professor Emeritus
Department of Comparative Medicine
College of Veterinary Medicine
University of Tennessee
Knoxville, TN

Katrina M. Waters, Ph.D.
Senior Staff Scientist
Technical Group Manager/Associate Division Director
Computational Sciences & Mathematics Division
Pacific Northwest National Laboratory
Richland, WA


[Federal Register: November 4, 2005 (Volume 70, Number 213)]
[Notices]
[Page 67157-67158]
[DOCID:fr04no05-37]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EC06-11-000, et al.]

Liberty Electric Power, LLC, et al.; Electric Rate and Corporate
Filings

October 26, 2005.
    The following filings have been made with the Commission. The
filings are listed in ascending order within each docket
classification.

1. Liberty Electric Power, LLC

[Docket No. EC06-11-000, ER01-2398-011]

    Take notice that on October 21, 2005, Liberty Electric Power, LLC
(Applicant) pursuant to section 203 of the Federal Power Act and part
33 of the Commission' regulations requests prior authorization for the
indirect disposition of jurisdictional facilities that will result from
transfers of equity interests in Applicant's indirect upstream owner,
LEP Holdings, LLC and gives notice of the change in status that will
result from the transactions in accordance with the requirements set
forth in Order No. 652.
    Comment Date: 5 p.m. Eastern Time on November 14, 2005.

2. Orion Power Holdings, Inc., Astoriz Generating Company, L.P., and
Astoria Generating Company Acquisitions, L.L.C.

[Docket No. EC06-12-000]

    Take notice that on October 21, 2005, Orion Power Holdings, Inc.,
Astoria Generating Company, L.P. and Astoria Generating Company
Acquisitions, L.L.C., (collectively, Applicants), tendered for filing
with the Commission, pursuant to section 203 of the Federal Power Act
and part 33 of the Commission's regulations, an application for
authorization that would allow Astoria Generating Company Acquisitions,
L.L.C. to acquire ownership interests in Astoria Generating Company,
L.P. Pursuant to 18 CFR Sec.  33.9 (2005), the Applicants seek
privileged treatment for Exhibits D and I to the application.
    Comment Date: 5 p.m. Eastern Time on November 14, 2005.

3. Select Energy, Inc. and Constellation Energy Commodities Group, Inc.

[Docket No. EC06-13-000]

    Take notice that on October 24, 2005, Select Energy, Inc., (Select)
and Constellation Energy Commodities Group, Inc. (collectively,
Applicants) filed a joint application pursuant to section 203 of the
Federal Power Act for

disposition of certain wholesale power sales contracts of Select.
    Comment Date: 5 p.m. Eastern Time on November 14, 2005.

4. NRG Energy, Inc. and Texas Genco LLC

[Docket No. EC06-14-000]

    Take notice that on October 24, 2005, NRG Energy, Inc., on behalf
of itself and its public utility subsidiaries (collectively, NRG) and
Texas Genco LLC (Texas Genco) submitted an application pursuant to
section 203 of the Federal Power Act for authorization of a disposition
of jurisdictional facilities whereby the owners of Texas Genco would
acquire certain amounts of NRG common stock as part consideration in
exchange for the transfer of their interest in Texas Genco to NRG. The
Applicants request confidential treatment of certain contracts and
written instruments pursuant to which the transaction would be
consummated.
    Comment Date: 5 p.m. Eastern Time on November 23, 2005.

5. Entegra Power Group LLC, Gila River Power, L.P. and Union Power
Partners, L.P.

[Docket No. EC06-15-000]

    Take notice that on October 24, 2005, Entegra Power Group LLC,
(Entegra), on behalf of itself and its wholly-owned subsidiaries Gila
River Power, L.P. and Union Power Partners, L.P. (together with
Entegra, Applicants), and on behalf of the current owners of equity
interests in Entegra, filed with the Commission an application pursuant
to section 203 of the Federal Power Act, requesting authorization for
an indirect disposition of FERC-jurisdictional facilities resulting
from certain proposed transfers of ownership of equity interests in
Entegra.
    Comment Date: 5 p.m. Eastern Time on November 15, 2005.

6. Boston Edison Company

[Docket no. EL02-123-008]

    Take notice that on October 17, 2005, Boston Edison Company
submitted for filing, pursuant to the Commission's Order issued
September 15, 2005, changes with respect to the service agreements for
the Town of Wellesley and the Town of Concord.
    Comment Date: 5 p.m. Eastern Time on November 16, 2005.

7. Luzenac America, Inc.

[Docket No. EL06-8-000]

    Take notice that on October 20, 2005, Luzenac America, Inc.
(Luzenac), pursuant to section 1290 of the Energy Policy Act of 2005
and Rules 206 and 207 of the Rules of Practice and Procedure of the
Federal Energy Regulatory Commission, filed a Petition for Relief
relating to a termination payment sought by Enron Power Marketing, Inc.
(Enron). In the Petition, Luzenac requests an expeditious determination
by FERC that the termination payment sought by Enron from Luzenac is
not permitted under Enron's rate schedule or its contract with Luzenac
entered into under such rate schedule, or is otherwise unlawful on the
grounds that the contract is unjust and unreasonable or contrary to the
public interest.
    Comment Date: 5 p.m. Eastern Time on November 10, 2005.

8. Midwest Renewable Energy Projects LLC

[Docket No. EL06-9-000]

    Take notice that on October 20, 2005, Midwest Renewable Energy
Projects LLC submitted to the Commission a petition to for declaratory
order regarding the recent amendments to the Public Utility Regulatory
Policies Act of 1978.
    Comment Date: 5 p.m. Eastern Time on November 10, 2005.

9. Devon Power LLC

[Docket No. ER04-23-014]

    Take notice that on October 11, 2005, Devon Power LLC, Middletown
Power LLC and Montville Power LLC (collectively, the NRG Companies),
pursuant to a deficiency letter issued on July 13, 2005 submitted for
filing a reconciliation of their annual informational filing.
    Comment Date: 5 p.m. Eastern Time on November 7, 2005.

10. The Detroit Edison Company

[Docket No. TS06-1-000]

    Take notice that on October 3, 2005, The Detroit Edison Company
(Detroit Edison) filed a request for clarification that it should not
be considered a transmission provider subject to the Standards of
Conduct promulgated in Order No. 2004. Detroit Edison requests full
waiver from the requirements of Order No. 2004, FERC Statutes and
Regulations ]31,355 (2003).
    Comment Date: 5 p.m. Eastern Time on November 10, 2005.

Standard Paragraph

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is 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 docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-6111 Filed 11-3-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: March 23, 2007 (Volume 72, Number 56)]
[Notices]
[Page 13837]
[DOCID:fr23mr07-131]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold the following meeting during the week
of March 26, 2007:
    A Closed Meeting will be held on Wednesday, March 28, 2007 at 2
p.m.
    Commissioners, Counsels to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters may also be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c) (5), (7), 9(B) and (10) and 17 CFR 200.402(a) (5),
(7), 9(ii) and (10) permit consideration of the scheduled matters at
the Closed Meeting.
    Commissioner Nazareth, as duty officer, voted to consider the items
listed for the closed meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Wednesday,
March 28, 2007 will be:

Formal orders of investigation;
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings of an
enforcement nature;
Resolution of litigation claims; and
Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: March 21, 2007.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-5429 Filed 3-22-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 83, Number 64 (Tuesday, April 3, 2018)]
[Notices]
[Pages 14310-14311]
[FR Doc No: 2018-06751]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Air Taxi and
Commercial Operator Airport Activity Survey

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for renewal of information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on

November 8, 2017. The collection involves requesting that small on-
demand operators voluntarily provide the number of revenue passengers
that boarded their aircraft at each airport annually. This information
is used in determining an airport's category and eligibility for
federal funding on an annual basis. It is not available through any
other federal data source.

DATES: Written comments should be submitted by May 3, 2018.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
[email protected], or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington,
DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

FOR FURTHER INFORMATION CONTACT: Barbara Hall at<PHONE_NUMBER>, or by
email at: [email protected].

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0067.
    Title: Air Taxi and Commercial Operator Airport Activity Survey.
    Form Numbers: FAA Form 1800-31.
    Type of Review: Clearance of a renewal of an information
collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on September 8, 2009 (74 FR 46292). The data collected
through this survey is the only source of data for charter and
nonscheduled passenger data by Part 135 operator (air taxis). The data
received on the form (either paper or signed electronic copy) is then
incorporated into the Air Carrier Activity Information System which is
used to determine whether an airport is eligible for Airport
Improvement Program funds and for calculating primary airport sponsor
apportionment as specified by title 49 United Stated Code (U.S.C.),
section 47114. The data collected on the form includes passenger
enplanements by carrier and by airport. Passengers traveling on air
taxis would be overlooked entirely if this passenger survey were not
conducted. As a result, many airports would not receive their fair
share of funds since there is currently no other source for this type
of charter activity. In each of the last 3 years, approximately 150
operators have reported a total 1.1 million passengers. This data is
important to those airports that struggle to meet the 2,500 and 10,000
passenger levels and could not do so without the reporting of the
charter passengers.
    Respondents: The voluntary survey is sent through the U.S. Postal
Service to approximately 300 small on-demand operators (certificated
under Federal Aviation Regulation Part 135) that have reported activity
in the last three years. The form is also available on the FAA website.
    Frequency: Annually.
    Estimated Average Burden per Response: 1.5 hours per respondent.
    Estimated Total Annual Burden: On average, approximately 150
respondents submit an annual response. The cumulative total annual
burden is estimated to be 225 hours.

    Issued in Washington, DC, on March 28, 2018.
Barbara Hall,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, ASP-110.
[FR Doc. 2018-06751 Filed 4-2-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Notices]
[Page 52717]
[FR Doc No: 2012-21475]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9724-1]

Underground Injection Control Program; Hazardous Waste Injection
Restrictions; Petition for Exemption--Class I Hazardous Waste
Injection; Cornerstone Chemical Company, Waggaman, LA

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of a final decision on a no migration petition
reissuance.

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SUMMARY: Notice is hereby given that a reissuance of an exemption to
the land disposal Restrictions, under the 1984 Hazardous and Solid
Waste Amendments to the Resource Conservation and Recovery Act, has
been granted to Cornerstone for four Class I injection wells located at
Waggaman, Louisiana. The company has adequately demonstrated to the
satisfaction of the Environmental Protection Agency by the petition
reissuance application and supporting documentation that, to a
reasonable degree of certainty, there will be no migration of hazardous
constituents from the injection zone for as long as the waste remains
hazardous. This final decision allows the continued underground
injection by Cornerstone, of the specific restricted hazardous wastes
identified in this exemption, into Class I hazardous waste injection
Wells 2, 3 4B and 5 at the Waggaman, Louisiana facility until June 30,
2016, unless EPA moves to terminate this exemption. Additional
conditions included in this final decision may be reviewed by
contacting the Region 6 Ground Water/UIC Section. A public notice was
issued June 28, 2012. The public comment period closed on August 13,
2012, and no comments were received. This decision constitutes final
Agency action and there is no Administrative appeal. This decision may
be reviewed/appealed in compliance with the Administrative Procedure
Act.

DATES: This action was effective as of August 20, 2012.

ADDRESSES: Copies of the petition and all pertinent information
relating thereto are on file at the following location: Environmental
Protection Agency, Region 6, Water Quality Protection Division, Source
Water Protection Branch (6WQ-S), 1445 Ross Avenue, Dallas, Texas 75202-
2733.

FOR FURTHER INFORMATION CONTACT: Philip Dellinger, Chief Ground Water/
UIC Section, EPA--Region 6, telephone<PHONE_NUMBER>.

    Dated: August 23, 2012.
Wren Stenger,
Acting Deputy Director, Water Quality Protection Division.
[FR Doc. 2012-21475 Filed 8-29-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Pages 24131-24132]
[FR Doc No: 2019-10878]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-7-000]

Tennessee Gas Pipeline Company, LLC; Notice of Availability of
the Environmental Assessment for the Proposed 261 Upgrade Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the 261
Upgrade Project, proposed by Tennessee Gas Pipeline Company, LLC
(Tennessee Gas) in the above-referenced docket. Tennessee Gas requests
authorization to provide 72,400 million cubic feet per day (Mcf/d) to
subscribed Project shippers. Tennessee Gas also requests approval to
upgrade facilities at Compressor Station 261 to increase reliability to
existing shippers. The Project includes modifications to existing
facilities and installation of new pipeline in Hampden County,
Massachusetts.
    The EA assesses the potential environmental effects of the
construction and operation of the 261 Upgrade Project in accordance
with the requirements of the National Environmental Policy Act (NEPA).
The FERC staff concludes that approval of the proposed project, with
appropriate mitigating measures, would not constitute a major federal
action significantly affecting the quality of the human environment.
    The U.S. Army Corps of Engineers participated as a cooperating
agency in the preparation of the EA. Cooperating agencies have
jurisdiction by law or special expertise with respect to resources
potentially affected by the proposal and participate in the NEPA
analysis.
    The proposed 261 Upgrade Project includes the following facilities:

Horsepower Replacement Project

     Abandon and replace two existing turbine compressor units
with one new turbine compressor unit and auxiliary facilities; and
     abandon and replace the emergency generator.

Looping Project

     Install 2.1 miles of 12-inch-diameter pipeline loop
adjacent to Tennessee Gas pipelines;
     install pig launcher and receiver facilities and tie-in
piping; and
     abandon and remove an inactive 6-inch-diameter pipeline.
    The Commission mailed a copy of the Notice of Availability to
federal, state, and local government representatives and agencies;
elected officials; environmental and public interest groups; Native
American tribes; potentially affected landowners and other interested
individuals and groups; and newspapers and libraries in the project
area. The EA is only available in electronic format. It may be viewed
and downloaded from the FERC's website (www.ferc.gov), on the
Environmental Documents page (https://www.ferc.gov/industries/gas/enviro/eis.asp). In addition, the EA may be accessed by using the
eLibrary link on the FERC's website. Click on the eLibrary link
(https://www.ferc.gov/docs-filing/elibrary.asp), click on General
Search, and enter the docket number in the ``Docket Number'' field,
excluding the last three digits (i.e. CP19-7). Be sure you have
selected an appropriate date range. For assistance, please contact FERC
Online Support at<EMAIL_ADDRESS>or toll free at (866) 208-
3676, or for TTY, contact<PHONE_NUMBER>.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the EA's disclosure and discussion of potential
environmental effects, reasonable alternatives, and measures to avoid
or lessen

environmental impacts. The more specific your comments, the more useful
they will be. To ensure that the Commission has the opportunity to
consider your comments prior to making its decision on this project, it
is important that we receive your comments in Washington, DC on or
before 5:00 p.m. Eastern Time on June 17, 2019.
    For your convenience, there are three methods you can use to file
your comments to the Commission. The Commission encourages electronic
filing of comments and has staff available to assist you at (866) 208-
3676 or<EMAIL_ADDRESS>Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's website (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's website (www.ferc.gov) under the
link to Documents and Filings. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address. Be sure to reference the project docket number
(CP19-7-000) with your submission: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington,
DC 20426
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR 385.214). Motions to intervene are more
fully described at http://www.ferc.gov/resources/guides/how-to/intervene.asp. Only intervenors have the right to seek rehearing or
judicial review of the Commission's decision. The Commission may grant
affected landowners and others with environmental concerns intervenor
status upon showing good cause by stating that they have a clear and
direct interest in this proceeding which no other party can adequately
represent. Simply filing environmental comments will not give you
intervenor status, but you do not need intervenor status to have your
comments considered.
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website (www.ferc.gov) using the eLibrary link. The eLibrary link
also provides access to the texts of all formal documents issued by the
Commission, such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: May 17, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-10878 Filed 5-23-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Pages 71648-71650]
[FR Doc No: 2021-27351]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0241]

Inspection of Injectable Products for Visible Particulates; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Inspection
of Injectable Products for Visible Particulates.'' Visible particulates
in injectable products can jeopardize patient safety. This draft
guidance addresses the development and implementation of a holistic,
risk-based approach to visible particulate control that incorporates
product development, manufacturing controls, visual inspection
techniques, particulate identification, investigation, and

corrective actions designed to assess, correct, and prevent the risk of
visible particulate contamination. The draft guidance also clarifies
that meeting an applicable U.S. Pharmacopeia (USP) compendial standard
alone is not generally sufficient for meeting the current good
manufacturing practice (CGMP) requirements for the manufacture of
injectable products.

DATES: Submit either electronic or written comments on the draft
guidance by February 15, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-0241 for ``Inspection of Injectable Products for Visible
Particulates.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
the Policy and Regulations Staff (HFV-6), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your requests. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Eric Dong, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 6652, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or Laura Huffman, Center for
Veterinary Medicine (HFV-140), Food and Drug Administration, Metro Park
North 2 (MPN2), Rm. Hotel CVM, 7500 Standish Pl., Rockville, MD 20855,
240-402-0664.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Inspection of Injectable Products for Visible
Particulates.'' Visible particulates in injectable products can
jeopardize patient safety. The draft guidance addresses a holistic
approach to visible particulate control that incorporates risk
assessment, prevention, inspection, identification, and remediation of
visible particulates in injectable products.
    Adherence to FDA's CGMP requirements. as set forth in section 501
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351)
and 21 CFR parts 210 and 211 for drug, animal drug, and biological
products; 21 CFR 600.10 through 600.15 for biological products; and 21
CFR part 4 for combination products, is essential for the control of
visible particulates in injectable products. Adherence to compendial
standards can also assist manufacturers in complying with CGMP
requirements. USP General Chapter <1> Injections and Implanted Drug
Products (Parenterals)--Product Quality Tests states that ``[t]he
inspection process should be designed and qualified to ensure that
every lot of all parenteral preparations is essentially free from
visible particulates'' as defined in USP General Chapter <790> Visible
Particulates in Injections. Injectable

products with a USP monograph are required to meet the applicable
criteria from these USP General Chapters (see section 501(b) of the
FD&C Act). Noncompendial products should also be ``essentially free
from visible particulates'' as defined in USP General Chapter <790>.
    Applying acceptance criteria, such as the criterion outlined in USP
General Chapter <790>, is an important component of the overall visible
particulate control program, but meeting these acceptance criteria
alone is not sufficient to ensure compliance with the applicable CGMP
requirements identified above, which cover a broader array of
manufacturing practices than product inspection. Full compliance with
CGMP requirements is needed to ensure the continued supply of pure,
safe, and effective injectable products.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Inspection
of Injectable Products for Visible Particulates.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR parts 211, 314, and 601 have been approved
under OMB control numbers 0910-0139, 0910-0001, and 0910-0308,
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 14, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27351 Filed 12-16-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 119 (Wednesday, June 20, 2018)]
[Proposed Rules]
[Pages 28550-28553]
[FR Doc No: 2018-13211]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0216; Product Identifier 1988-ANE-18-AD]
RIN 2120-AA64

Airworthiness Directives; Honeywell International Inc. Turboprop
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede Airworthiness Directive (AD) 88-12-10,
which applies to certain Honeywell International Inc. (Honeywell)
TPE331 turboprop engines. AD 88-12-10 requires reducing the life limit
for certain second stage turbine rotors. Since we issued AD 88-12-10,
we received a report that a TPE331-11U engine experienced an
uncontained rotor separation. In addition, cracks were discovered
through eddy current inspection (ECI) in the bore of the second stage
turbine rotor assembly after publication of AD 88-12-10. This proposed
AD would require removing certain second stage turbine rotors from
service at a reduced life limit. We are proposing this AD to address
the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by August 6, 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 Honeywell
International Inc., 111 S 34th Street, Phoenix, AZ 85034-2802; phone:
800-601-3099; internet: https://myaerospace.honeywell.com/wps/portal.
You may view this service information at the FAA, Engine and Propeller
Standards Branch, 1200 District Avenue, Burlington, MA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

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-
0216; 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 listed above. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Joseph Costa, Aerospace Engineer, Los
Angeles ACO Branch, FAA, 3960 Paramount Blvd., Lakewood, CA 90712-4137;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2018-0216;
Product Identifier 1988-ANE-18-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

    We issued AD 88-12-10, Amendment 39-5910 (53 FR 19766, May 31,
1988), (``AD 88-12-10''), for certain Honeywell TPE331 turboprop
engines. AD 88-12-10 requires reducing the life limit for certain
second stage turbine rotors. AD 88-12-10 resulted from the failure of a
second stage turbine rotor due to crack growth from a bore initiation
site induced by low cycle fatigue. We issued AD 88-12-10 to prevent
failure of the second stage turbine rotor, leading to uncontained
failure of the second stage turbine rotor.

Actions Since AD 88-12-10 Was Issued

    Since we issued AD 88-12-10, a TPE331-11U engine installed on an M7
Aerospace LP SA227 airplane experienced an uncontained tri-hub rotor
separation during climb on April 7, 2015. One of the three fragments
from the second stage turbine rotor assembly, part number 3102106-6,
came to rest inside the fuselage wall of the twin-engine airplane. In
addition, second stage turbine rotor assembly cracks in the bore were
discovered by ECI after publication of AD 88-12-10. This evidence
supports higher stresses than originally calculated and supports the
inability of the normal rotor inspection method, fluorescent penetrant
inspection, to detect small cracks in the bore. In addition, we are
adding the TPE331-8 and -10N model engines to the applicability of this
AD because the design and material of its second stage turbine rotor
are similar to those in the TPE331-10, -10R, -10U, -10UA, -10UF, -10UG,
-10UGR, -10UR, and -11U model engines.

Related Service Information

    We reviewed Honeywell Service Bulletin (SB) TPE331-72-A2319,
Revision 0, dated April 25, 2018 and TPE331-72-A2310, Revision 0, dated
January 26, 2018. These SBs describe procedures for replacement of the
second stage turbine rotor assembly installed on TPE331-8, -10, -10N, -
10R, -10U, -10UA, -10UF, -10UG, -10UGR, -10UR, and -11U model engines.

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 retain certain requirements of AD 88-12-10.
This proposed AD would require removing certain second stage turbine
rotors from service at a reduced life limit.

Differences Between This Proposed AD and the Service Information

    This NPRM proposes to allow certain rotors more time in service
before their removal than is allowed by Honeywell SBs TPE331-72-A2310,
Revision 0, dated January 26, 2018, and TPE331-72-A2319, Revision 0,
dated April 25, 2018. The FAA finds that allowing an additional 100
cycles in service before their removal provides a sufficient level of
safety for applicable second stage turbine rotors that have been in
service for 30 years after the publication of AD 88-12-10. In addition,
the SB includes a calendar deadline of 5 years for removal of the
applicable second stage turbine rotors that have exceeded their life-
limit of 3,000 cycles. The FAA is instead proposing a requirement to
remove applicable rotors at the next access and prohibiting the
installation of applicable rotors. We find that the calendar deadline
is inconsistent with our compliance requirements.

Costs of Compliance

    We estimate that this proposed AD affects 100 engines installed on
airplanes of U.S. registry.
    We estimate that 20 commercial engines and 80 general aviation
engines will need this turbine rotor replacement to comply with this
proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Scheduled rotor replacement...........  1 work-hour x $85 per             $7,500          $7,585        $379,250
                                         hour = $85.
Unscheduled rotor replacement.........  41 work-hours x $85 per            7,500          10,985         549,250
                                         hour = $3,485.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    We have 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 that the 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 removing Airworthiness Directive (AD)
88-12-10, Amendment 39-5910 (53 FR 19766, May 31, 1988), and adding the
following new AD:

Honeywell International Inc. (Type Certificate previously held by
AlliedSignal Inc., Garrett Engine Division; Garrett Turbine Engine
Company; and AiResearch Manufacturing Company of Arizona): Docket
No. FAA-2018-0216; Product Identifier 1988-ANE-18-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by August 6,
2018.

(b) Affected ADs

    This AD replaces AD 88-12-10, Amendment 39-5910 (53 FR 19766,
May 31, 1988) (``AD 88-12-10'').

(c) Applicability

    This AD applies to Honeywell International Inc. (Honeywell)
TPE331-8, -10, -10N, -10R, -10U, -10UA, -10UF, -10UG, -10UGR, -10UR,
and -11U turboprop engines with second stage turbine rotor
assemblies, part number (P/Ns) 3102106-1, -6, and -8 or P/N 3101514-
1, -10 and -12, installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7250, Turbine
Section.

(e) Unsafe Condition

    This AD was prompted by a report that a TPE331-11U engine
installed on an M7 SA227 airplane experienced an uncontained rotor
separation and the discovery of cracks in the bore of the second
stage turbine rotor assembly after publication of AD 88-12-10. We
are issuing this AD to prevent failure of the second stage turbine
rotor. The unsafe condition, if not addressed, could result in
uncontained release of the second stage turbine rotor, damage to the
engine, and damage to the airplane.

(f) Compliance

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

(g) Required Actions

    (1) Remove from service the applicable second stage turbine
rotor assembly, P/Ns 3102106-1, -6 and -8, according to the schedule
in Table 1 to Paragraph (g)(1) of this AD:
[GRAPHIC] [TIFF OMITTED] TP20JN18.005

    (2) Remove from service the applicable second stage turbine
rotor assembly, P/Ns 3101514-1, -10 and -12, per the schedule in
Table 2 to Paragraph (g)(2) of this AD:

[GRAPHIC] [TIFF OMITTED] TP20JN18.006

(h) Definition

    For the purpose of this AD, ``next access'' is defined as when
the applicable second stage turbine rotor assembly is removed from
the engine.

(i) Installation Prohibition

    As of the effective date of this AD, do not install second stage
turbine rotor assemblies, P/Ns 3102106-1, -6, and -8 and P/Ns
3101514-1, -10, and -12 on any engine.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles ACO, 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 (k)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    (1) For more information about this AD, contact Joseph Costa,
Aerospace Engineer, Los Angeles ACO Branch, FAA, 3960 Paramount
Blvd., Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>; fax: 562-627-
5210; email: [email protected].
    (2) For service information identified in this AD, contact
Honeywell International Inc., 111 S 34th Street, Phoenix, AZ 85034-
2802; phone:<PHONE_NUMBER>; internet: https://myaerospace.honeywell.com/wps/portal. You may view this referenced
service information at the FAA, Engine and Propeller Standards
Branch, 1200 District Avenue, Burlington, MA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on June 14, 2018.
Robert J. Ganley,
Manager, Engine and Propeller Standards Branch, Aircraft Certification
Service.
[FR Doc. 2018-13211 Filed 6-19-18; 8:45 am]
 BILLING CODE 4910-13-P