[Federal Register Volume 86, Number 126 (Tuesday, July 6, 2021)]
[Proposed Rules]
[Pages 35420-35421]
[FR Doc No: 2021-14199]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0471; Airspace Docket No. 21-AGL-25]
RIN 2120-AA66

Proposed Revocation of Class E Airspace and Amendment of Class E
Airspace; Peebles and West Union, OH

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to revoke the Class E extending upward
from 700 feet above the surface at Peebles, OH; and amend the Class E
airspace extending upward from 700 feet above the surface at Alexander
Salamon Airport, West Union, OH. The FAA is proposing this action as
the result of airspace reviews caused by the decommissioning of the
West Union non-federal non-directional beacon (NDB). The geographic
coordinates of the Alexander Salamon Airport would also be updated to
coincide with the FAA's aeronautical database.

DATES: Comments must be received on or before August 20, 2021.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2021-0471/Airspace Docket No. 21-AGL-25 at the beginning of your
comments. You may also submit comments through the internet at https://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 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11E, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email:
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. 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 revoke the Class E extending upward from 700 feet above the
surface at Peebles, OH; and amend the Class E airspace extending upward
from 700 feet above the surface at Alexander Salamon Airport, West
Union, OH, to support instrument flight rule operations at this
airport.

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-2021-0471/Airspace Docket No. 21-AGL-25.''
The postcard will be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/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 the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11E, Airspace
Designations and Reporting Points, dated July 21, 2020, and effective
September 15, 2020. FAA Order 7400.11E is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11E lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 by:
    Revoking the Class E airspace extending upward from 700 feet above
the surface at Peebles, OH;
    And amending the Class E airspace extending upward from 700 feet
above the surface to within a 6.4-mile (decreased from a 7.7-mile)
radius of Alexander Salamon Airport, West Union, OH; removing the name
associated with the airport to comply with changes to FAA Order
7400.2M, Procedures for Handling Airspace Matters; and updating the
geographic coordinates of the airport to coincide with the FAA's
aeronautical database.
    This action is due to airspace reviews caused by the
decommissioning of the West Union non-federal NDB and the closure of
the airport and cancellation of the instrument procedures at Peebles,
OH.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11E, dated July 21, 2020, and effective September 15,
2020, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. 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, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, 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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL OH E5 Peebles, OH [Removed]

* * * * *

AGL OH E5 West Union, OH [Amended]

Alexander Salamon Airport, OH
    (Lat. 38[deg]51'06'' N, long. 83[deg]33'58'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of the Alexander Salamon Airport.

    Issued in Fort Worth, Texas, on June 29, 2021.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2021-14199 Filed 7-2-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 198 (Tuesday, October 13, 2020)]
[Notices]
[Page 64457]
[FR Doc No: 2020-22574]

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ENVIRONMENTAL PROTECTION AGENCY

[[EPA-HQ-ORD-2015-0467; FRL-10014-48-ORD]

Board of Scientific Counselors (BOSC) Safe and Sustainable Water
Resources Subcommittee Meeting--October 2020; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public meeting; correction.

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SUMMARY: The Environmental Protection Agency (EPA), Office of Research
and Development (ORD), published a document in the Federal Register of
August 24, 2020, giving notice of a meeting of the Board of Scientific
Counselors (BOSC) Safe and Sustainable Water Resources (SSWR)
Subcommittee.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer (DFO)
via phone/voice mail at:<PHONE_NUMBER>; via fax at:<PHONE_NUMBER>; or
via email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Correction

    In the Federal Register of August 24, 2020, in FR Doc. 2020-18516,
on page 52130, column 2 correct the ``Dates'' caption to read:

DATES:

    1. The initial meeting will be held over two days via
videoconference:
    a. Wednesday, October 28, 2020, from 12 p.m. to 5 p.m. (EDT); and
    b. Thursday, October 29, 2020, from 12 p.m. to 5 p.m. (EDT).
    Attendees must register by October 27, 2020.
    2. A BOSC deliberation will be held on November 17, 2020 from 11
a.m. to 2 p.m. (EDT). Attendees must register by November 16, 2020.
    3. A final summary teleconference will be held on December 2, 2020
from 2 p.m. to 5 p.m. (EDT). Attendees must register by December 1,
2020.
    Meeting times are subject to change. These series of meetings are
open to the public. Comments must be received by October 27, 2020, to
be considered by the subcommittee. Requests for the draft agenda or
making a presentation at the meeting will be accepted until October 27,
2020.

Mary Ross,
Director, Office of Science Advisor, Policy and Engagement.
[FR Doc. 2020-22574 Filed 10-9-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 185 (Monday, September 24, 2018)]
[Notices]
[Pages 48304-48305]
[FR Doc No: 2018-20683]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-543-000]

Coronado Midstream LLC; Notice of Application

    Take notice that on August 30 2018, Coronado Midstream LLC
(Coronado), 1722 Routh Street, Suite 1300, Dallas, Texas 75201, filed
an application under section 7(c) of the Natural Gas Act and Part 157
of the Commission's regulations requesting authorization to own and
operate existing natural gas residue lines connected to three
processing plants in Andrews County and Martin County, Texas, and for
related waivers. Specifically, Coronado requests (1) a limited
jurisdiction certificate authorizing Coronado to transport natural gas
owned solely by Coronado through existing residue lines connected to
the tailgate outlets of Coronado's Midmar East processing plant, Midmar
West processing plant, and Riptide processing plant; and (2) a waiver
of certain regulatory requirements.
    This filing is available for review at the Commission's Washington,
DC offices, or may be viewed on the Commission's website at http://www.ferc.gov using the e-Library link. Enter the docket number,
excluding the last three digits, in the docket number field to access
the document. For assistance, please contact FERC Online Support at
[email protected], or call toll-free at<PHONE_NUMBER>, or for
TTY, contact<PHONE_NUMBER>.
    Any questions regarding the filing should be directed to Emily
Fuquay, Senior Counsel & Director of Regulatory Affairs at the address
listed above, by

phone at<PHONE_NUMBER>, or via email at [email protected]; and
Kenneth W.Irvin, Sidley Austin LLP, 1501 K Street NW, Washington, DC
20005, by phone at 202-736- 8256, or via email at [email protected].
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 5 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    The Commission strongly encourages electronic filings of comments,
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 7 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426.
    There is an eSubscription link on the website that enables
subscribers to receive email notification when a document is added to a
subscribed docket(s). For assistance with any FERC Online service,
please email [email protected], or call<PHONE_NUMBER> (toll
free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m., October 3, 2018.

    Dated: September 12, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-20683 Filed 9-21-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: January 12, 2009 (Volume 74, Number 7)]
[Notices]
[Page 1275-1276]
[DOCID:fr12ja09-128]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[NHTSA Docket No. NHTSA-2009-0001]

 Notice of Federal Advisory Committee Meeting

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: National Emergency Medical Services Advisory Council (NEMSAC);
Notice of Federal Advisory Committee Meeting.

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SUMMARY: The NHTSA announces a meeting of NEMSAC to be held in the
Metropolitan Washington, DC area. This notice announces the date, time
and location of the meeting, which will be open to the public. The
purpose of NEMSAC is to provide a nationally recognized council of
emergency medical services representatives and consumers to provide
advice and recommendations regarding Emergency Medical Services (EMS)
to the U.S. DOT's NHTSA.

DATES: The meeting will be held on January 29, 2009, from 1 p.m. to 5
p.m., and January 30, 2009, from 8 a.m. to 11 a.m. A public comment
period will take

place on January 30, 2009, between 10 a.m. and 10:30 a.m.
    Comment Date: Written comments or requests to make oral
presentations must be received by January 22, 2009.

ADDRESSES: The meeting will be held at the Marriott Crystal City at
Reagan National Airport, 1999 Jefferson Davis Highway, Arlington, VA
22202. Persons wishing to make an oral presentation or who are unable
to attend or speak at the meeting may submit written comments. Written
comments and requests to make oral presentations at the meeting should
reach Drew Dawson at the address listed below and must be received by
January 22, 2009. All submissions received must include the docket
number, NHTSA-2009-0001, and may be submitted by any one of the
following methods: You may submit or retrieve comments online through
the Document Management System (DMS) at http://www.regulations.gov/
under the docket number listed at the beginning of this notice. The DMS
is available 24 hours each day, 365 days each year. Electronic
submission and retrieval help guidelines are available under the help
section of the Web site.
    An electronic copy of this document may be downloaded from the
Federal Register's home page at http://www.archives.gov and the
Government Printing Office's database at http://www.access.gpo.gov/
nara.
    Please note that even after the comment closing date, we will
continue to file relevant information in the docket as it becomes
available.
    E-mail<EMAIL_ADDRESS>or<EMAIL_ADDRESS>    Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Drew Dawson, Director, Office of
Emergency Medical Services, National Highway Traffic Safety
Administration, 1200 New Jersey Avenue, SE., NTI-140, Washington, DC
20590, Telephone number<PHONE_NUMBER>; E-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5
U.S.C. App. 1 et seq.) The NEMSAC will be holding its third meeting on
Thursday and Friday, January 29 and 30, 2009, at the Marriott Crystal
City at Reagan National Airport, 1999 Jefferson Davis Highway,
Arlington, VA 22202.

Agenda of Council Meeting, January 29-30, 2009

    The tentative agenda includes the following:

Thursday, January 29, 2009
    (1) Opening Remarks;
    (2) Introduction of Members and all in attendance;
    (3) Review and Approval of Minutes of last Meeting;
    (4) Presentation by National EMS Management Association
representative regarding the Emergency Medical Services Management and
Leadership Development in America: An Agenda for the Future;
    (5) EMS Workforce Agenda for the Future Presentation;
    (6) Committee Reports and Discussion.

Friday, January 30, 2009
    (1) Welcome and Introductions;
    (2) Unfinished Business from January 29;
    (3) Public Comment Period;
    (4) Next Steps and Future Meetings.

    A public comment period will take place on January 30, 2009,
between 10 a.m. and 10:30 a.m.
    Public Attendance: The meeting is open to the public. Persons with
disabilities who require special assistance should advise Drew Dawson
of their anticipated special needs as early as possible. Members of the
public who wish to make comments on Friday, January 30 between 10 a.m.
and 10:30 a.m. are requested to register in advance. In order to allow
as many people as possible to speak, speakers are requested to limit
their remarks to 3 minutes. For those wishing to submit written
comments, please follow the procedure noted above.
    This meeting will be open to the public. Individuals wishing to
register must provide their name, affiliation, phone number, and e-mail
address to Drew Dawson by e-mail at<EMAIL_ADDRESS>or by telephone
at<PHONE_NUMBER> no later than January 22, 2009. There will be limited
seating, so please register early. Pre-registration is necessary to
enable proper arrangements.
    Minutes of the NEMSAC Meeting will be available to the public
online through the DOT Document Management System (DMS) at: http://
www.regulations.gov under the docket number listed at the beginning of
this notice.

    Issued on: January 6, 2009.
Jeffrey P. Michael,
Associate Administrator for Research and Program Development.
[FR Doc. E9-288 Filed 1-9-09; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)]
[Notices]
[Pages 78605-78606]
[FR Doc No: 2016-26931]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0075]

Non-Inferiority Clinical Trials To Establish Effectiveness;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Non-Inferiority
Clinical Trials to Establish Effectiveness.'' This document provides
guidance to sponsors and applicants submitting investigational new drug
applications (INDs), new drug applications (NDAs), biologics licensing
applications (BLAs), or supplemental applications on the appropriate
use of non-inferiority (NI) study designs to provide evidence of the
effectiveness of a drug or biologic. The guidance gives advice on when
NI studies demonstrating effectiveness of an investigational drug can
provide interpretable results, how to choose the NI margin, and how to
test the NI hypothesis.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

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-2010-D-0075 for ``Non-Inferiority Clinical Trials to Establish
Effectiveness; Guidance for Industry.'' 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.
    Submit written requests for single copies of this 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 or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Scott Goldie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire

Ave., Bldg. 21, Rm. 3557, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Robert Temple, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4212,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or 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>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Non-Inferiority Clinical Trials to Establish
Effectiveness.'' This guidance consists of four parts. The first part
is a general discussion of regulatory, study design, scientific, and
statistical issues associated with the use of NI studies to establish
the effectiveness of a drug or biologic. The second part focuses on
some of these issues in more detail, notably the statistical approaches
used to determine the NI margin and to test for non-inferiority. The
third part addresses commonly asked questions about NI studies. The
fourth part includes four examples of successful and unsuccessful
efforts to define NI margins and test for non-inferiority.
    This guidance finalizes the draft guidance for industry, ``Non-
Inferiority Clinical Trials,'' published in 2010. In addition, it
supersedes the guidance for industry, ``Antibacterial Drug Products:
Use of Noninferiority Trials to Support Approval,'' also published in
2010, which will be withdrawn.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on NI clinical trials to establish
effectiveness. 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. Electronic Access

    Persons with access to the Internet may obtain the guidance at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm; http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm; or
http://www.regulations.gov.

    Dated: November 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26931 Filed 11-7-16; 8:45 am]
 BILLING CODE 4164-01-P