[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)]
[Notices]
[Pages 62910-62911]
[FR Doc No: 2016-21969]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1143]

Use of Nucleic Acid Tests To Reduce the Risk of Transmission of
West Nile Virus From Living Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products; 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 document entitled ``Use of Nucleic Acid Tests to
Reduce the Risk of Transmission of West Nile Virus from Living Donors
of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/
Ps); Guidance for Industry.'' The guidance document provides
establishments that make donor eligibility determinations for donors of
HCT/Ps with recommendations for testing living donors for West Nile
Virus (WNV). Specifically, the guidance provides recommendations
regarding the use of an FDA-licensed nucleic acid test (NAT) to test
living donors of HCT/Ps for evidence of infection with WNV. The
guidance does not provide recommendations regarding testing of
cadaveric HCT/P donors for WNV. The guidance announced in this notice
finalizes the draft guidance of the same title dated December 2015.
This guidance supplements the donor screening recommendations for WNV
(which will remain in place) in sections IV.E. (recommendations 15 and
16) and IV.F. (recommendation 5), and supersedes the ``West Nile Virus
(WNV)'' section in Appendix 6 of the guidance entitled ``Guidance for
Industry: Eligibility Determination for Donors of Human Cells, Tissues,
and Cellular and Tissue-Based Products (HCT/Ps)'' dated August 2007
(2007 Donor Eligibility Guidance).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
guidance before it begins work on the final version of the guidance,
submit either electronic or written comments on the guidance by
December 12, 2016.

SUPPLEMENTARY INFORMATION:
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-2013-D-1143 for ``Use of Nucleic Acid Tests to Reduce the Risk of
Transmission of West Nile Virus from Living Donors of Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps); 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 the guidance to 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 the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

I. Background

    FDA is announcing the availability of a document entitled ``Use of
Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile
Virus From Living Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps); Guidance for Industry.'' The guidance
document provides establishments that make donor eligibility
determinations for donors of HCT/Ps with recommendations for testing
living donors for WNV. The guidance does not provide recommendations
regarding testing of cadaveric HCT/P donors for WNV. FDA believes that
the use of an FDA-licensed NAT will reduce the risk of transmission of
WNV from living donors of HCT/Ps and therefore recommends that you use
an FDA-licensed NAT for testing living donors of HCT/Ps for infection
with WNV as set forth in the guidance. The 2007 Donor Eligibility
Guidance indicated that FDA may recommend routine use of an
appropriate, licensed donor screening test(s) to detect acute
infections with WNV using NAT technology, once such tests were
available.
    In the Federal Register of December 15, 2015 (80 FR 77645), FDA
announced the availability of the draft guidance entitled ``Use of
Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile
Virus from Living Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps); Draft Guidance for Industry'' dated
December 2015 (December 2015 draft guidance). FDA received several
comments on the draft guidance and those comments were considered as
the guidance was developed.
    In the Federal Register of February 28, 2007 (72 FR 9007), FDA
announced the availability of the 2007 Donor Eligibility Guidance. FDA
issued a revised version of this guidance under the same title, dated
August 2007 (2007 Donor Eligibility Guidance).
    The guidance announced in this notice finalizes the December 2015
draft guidance and supplements sections IV.E. (recommendations 15 and
16) and IV.F. (recommendation 5), and supersedes the ``West Nile Virus
(WNV)'' section in Appendix 6 of the 2007 Donor Eligibility Guidance.
    The 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 ``Use of Nucleic Acid Tests to Reduce the
Risk of Transmission of West Nile Virus from Living Donors of Human
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).'' 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
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: September 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21969 Filed 9-12-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: March 18, 2009 (Volume 74, Number 51)]
[Notices]
[Page 11539-11540]
[DOCID:fr18mr09-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM08-2-001]

Pipeline Posting Requirements Under Section 23 of the Natural Gas
Act; Notice of Agenda for Technical Conference

March 11, 2009.
    On February 24, 2009, the Commission issued a Notice of Technical
Conference (February 24 Notice), to be held March 18, 2009, in the
above referenced proceeding. The technical conference is being held by
staff for the purpose of discussing certain issues raised in the
requests for rehearing filed in response to Order No. 720.\1\ As stated
in the February 24 Notice, the technical conference will be held at the
headquarters of the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC, from 9 a.m. to 1 p.m. (EDT).
---------------------------------------------------------------------------

    \1\ Pipeline Posting Requirements under Section 23 of the
Natural Gas Act, Order No. 720, FERC Stats. & Regs. ] 31,281 (2008).
---------------------------------------------------------------------------

    Attached is an agenda for the March 18, 2009, technical conference.
The February 24 Notice identified three topics for discussion: (1) The
definition of major non-interstate pipelines; (2) what constitutes
``scheduling'' for a receipt or delivery point; and, (3) how the 15,000
MMBtu per day design capacity threshold should be applied. As reflected
in the attached agenda, Panel 1 will address the first topic, with a
focus on contiguous and non-contiguous networks, stub lines and other
gathering issues; Panel 2 will address the second and third topics,
with a focus on how pipeline systems account for high capacity receipt
and delivery points (i.e., greater than 15,000 MMBtu per day) where
scheduling does not occur; and, Panel 3 will focus on estimating the
cost of compliance with Order No. 720.
    This conference will be transcribed. There is no registration
required to attend and no registration fee. For additional information,
please contact Saida Shaalan of FERC's Office of Enforcement at (202)
502-8278 or by e-mail at<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.

Agenda for Technical Conference

Order No. 720 Rehearing Issues Technical Conference RM08-02-001

March 18, 2009
Commission Meeting Room
9-9:10 a.m.--Opening Remarks
9:10-9:50 a.m.--Defining Major Non-Interstate Pipelines
    Assessing contiguous and non-contiguous networks

--What constitutes a contiguous pipeline system for the purpose of
applying the annual 50 million MMBtu delivery threshold?
--What are the market differences between non-contiguous pipeline
systems with the same owner and a single pipeline system?

    Stub lines and other gathering issues

--What role do stub lines play in the market? How are they operated?
--What gathering functions do not occur upstream of a processing plant?
How widespread are those activities (e.g., volumes)?

Panelists:
    Representative from TPA
    Representative from Southwest Gas
    Representative from AGA
9:50 a.m.-12 p.m.--Accounting for High Capacity Receipt and Delivery
Points (i.e., Greater than 15,000 MMBtu Per Day) Where Scheduling Does
Not Occur
    Is there some rule of thumb to identify points at which advance
notice of receipts/deliveries is required for operational purposes?
    How do companies without scheduling information address the risk of
demand volatility from large scale consumers receiving unbundled
service?
    How do pipelines reconcile nominations with actual flows at pooled
points?
Panelists:
    Representative from TPA
    Representative from SoCal Gas
    Representative from Nicor
    Representative from AGA
12:10-12:50 p.m.--Estimating the Cost of Compliance
    What is the basis for cost estimates in the rehearing requests?
    Are there alternative approaches that

would reduce costs?
Panelists:
    Representative from SoCal Gas
    Representative from TPA
12:50-1 p.m.--Closing Remarks

[FR Doc. E9-5776 Filed 3-17-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 152 (Thursday, August 7, 2014)]
[Notices]
[Pages 46274-46275]
[FR Doc No: 2014-18644]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4186-DR; Docket ID FEMA-2014-0003]

South Dakota; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of South Dakota (FEMA-4186-DR), dated July 28,
2014, and related determinations.

DATES: Effective Date: July 28, 2014.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 28, 2014, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of South Dakota resulting from severe storms, tornadoes, and
flooding during the period of June 13-20, 2014, is of sufficient
severity and magnitude to warrant a major disaster declaration under
the Robert T. Stafford Disaster Relief and Emergency Assistance Act,
42 U.S.C. 5121 et seq. (the ``Stafford Act''). Therefore, I declare
that such a major disaster exists in the State of South Dakota.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Gary R. Stanley, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of South Dakota have been
designated as adversely affected by this major disaster:

    Butte, Clay, Corson, Dewey, Hanson, Jerauld, Lincoln, Minnehaha,
Perkins, Turner, Union, and Ziebach Counties and the Standing Rock
Sioux Tribe within Corson County for Public Assistance.
    All counties and Indian Tribes within the State of South Dakota
are eligible to apply for assistance under the Hazard Mitigation
Grant Program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2014-18644 Filed 8-6-14; 8:45 am]
BILLING CODE 9111-23-P


        ~DRAFT AGENDA~                    U.S. ENVIRONMENTAL PROTECTION AGENCY (EPA)                        TOXIC SUBSTANCES CONTROL ACT (TSCA)                 SCIENCE ADVISORY COMMITTEE ON CHEMICALS (SACC)                                VIRTUAL PUBLIC MEETING                                    May 26-29, 2020                                                           TSCA SACC WEB SITE: http://www.epa.gov/tsca-peer-review                       DOCKET NUMBER: EPA - HQ - OPPT - 2019 - 0502                                                                  MEETING LOCATION: Phone and Webcast                                             For Video Link and Audio Registration (to Receive call-in number) go to:                       http://www.epa.gov/tsca-peer-review                                                    [Please note that all times are approximate as noted at the      end of the Agenda. Agency speakers may change based on availability.]                                          Title:  Peer Review for the U.S. EPA Draft Risk Evaluation for Perchloroethylene                                          Day 1                                 Tuesday, May 26, 2020                                         Day 1                                 Tuesday, May 26, 2020

                    10:00 A.M. 	Opening of Meeting  -  Tamue Gibson, M.S., Designated Federal Official, EPA, Office of Chemical Safety and Pollution Prevention (OCSPP), Office of Science Coordination and Policy (OSCP)

  10:10 A.M. 	Introduction and Identification of Committee Members  -  Kenneth Portier, Ph.D., TSCA Science Advisory Committee on Chemicals (SACC) Chair

  10:20 A.M.		Introduction and Welcome  -  EPA, OCSPP, Office of Pollution Prevention and             Toxics (OPPT), Immediate Office

  10:30 A.M. 	OPPT Technical Presentation  -  Overview of Perchloroethylene Draft Risk Evaluation  -  Mari Lee, Ph.D., EPA, OPPT, Risk Assessment Division (RAD)    11:45 A.M.		Break

  12:00 P.M. 		SACC Discussion on OPPT Technical Presentation

    1:00 P.M. 		Lunch

    1:45 P.M.		Public Comments            2:00 P.M. 		Charge Question 1: Environmental Fate and Transport           2:30 P.M. 		Charge Question 2: Environmental Releases and Exposure

           3:45 P.M. 		Charge Question 3: Environmental Hazards

     4:15 P.M.		Adjourn

                                           Day 2                                 Wednesday, May 27, 2020                                        Day 2                                 Wednesday, May 27, 2020

                    10:00 A.M. 	Opening of Meeting  -  Tamue Gibson, M.S., Designated Federal Official, EPA, OCSPP, OSCP

  10:05 A.M. 	Committee Members: Follow-up from the Previous Day  -  Kenneth Portier, Ph.D., TSCA SACC Chair

  10:15 A.M. 		Charge Question 4: Occupational and Consumer Exposure

  11:45 A.M. 		Break

 12:00 P.M. 		Charge Question 4: Occupational and Consumer Exposure (continued)

    1:00 P.M. 		Lunch

   1:45 P.M. 		Charge Question 4: Occupational and Consumer Exposure (continued)            3:15 P.M. 		Break

   3:30 P.M. 		Charge Question 4: Occupational and Consumer Exposure (continued)            4:15 P.M.		Adjourn

                                        Day 3                                 Thursday, May 28, 2020                                        Day 3                                 Thursday, May 28, 2020

                     10:00 A.M. 	Opening of Meeting  -  Tamue Gibson, M.S., Designated Federal Official, EPA, OCSPP, OSCP

   10:05 A.M. 	Committee Members: Follow-up from the Previous Day  -  Kenneth Portier, Ph.D., TSCA SACC Chair

   10:15 A.M. 		Charge Question 5: Human Health Hazard

  11:15 A.M. 		Break

   11:30 A.M. 		Charge Question 5: Human Health Hazard (continued)

     1:00 P.M. 		Lunch              1:45 P.M. 		Charge Question 5: Human Health Hazard (continued)              2:15 P.M. 		Charge Question 6: Risk Characterization

    3:45 P.M. 		Break

    4:00 P.M. 		Charge Question 6: Risk Characterization (continued)

    5:15 P.M. 		Adjourn

                                        Day 4                                  Friday, May 29, 2020                                        Day 4                                  Friday, May 29, 2020

                    10:00 A.M. 	Opening of Meeting  -  Tamue Gibson, M.S., Designated Federal Official, EPA, OCSPP, OSCP

  10:05 A.M. 	Committee Members: Follow-up from the Previous Day  -  Kenneth Portier, Ph.D., TSCA SACC Chair

 11:30 A.M. 		Break

  11:45 A.M. 		Charge Question 7: Overall Content and Organization                                1:00 P.M. 	Closing Remarks  -  Kenneth Portier, Ph.D., TSCA SACC Chair                       1:15 P.M. 		Adjourn


[Federal Register Volume 78, Number 60 (Thursday, March 28, 2013)]
[Rules and Regulations]
[Pages 18798-18799]
[FR Doc No: 2013-06908]

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

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-1434; Airspace Docket No. 11-ACE-27]

Amendment of Class E Airspace; West Union, IA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Class E airspace at West Union, IA.
Decommissioning of the West Union non-directional beacon (NDB) at
George L. Scott Municipal Airport has made reconfiguration necessary
for standard instrument approach procedures and for the safety and
management of Instrument Flight Rule (IFR) operations at the airport.

DATES: Effective date: 0901 UTC, June 27, 2013. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

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:

History

    On November 30, 2012, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend Class E airspace for the
West Union, IA, area, creating additional controlled airspace at George
L. Scott Municipal Airport (77 FR 71361) Docket No. FAA-2011-1434.
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received. Class E airspace designations are published in
paragraph 6005 of FAA Order 7400.9W dated August 8, 2012, and effective
September 15, 2012, which is incorporated by reference in 14 CFR 71.1.
The Class E airspace designations listed in this document will be
published subsequently in the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace extending upward from 700 feet
above the surface

at George L. Scott Municipal Airport, West Union, IA. Decommissioning
of the West Union non-directional beacon (NDB) at George L. Scott
Municipal Airport has made reconfiguration necessary for standard
instrument approach procedures and for the safety and management of
Instrument Flight Rule (IFR) operations within a 6.4-mile radius of the
airport.
    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.
Therefore, this regulation: (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 amends controlled airspace at George L. Scott Municipal Airport,
West Union, IA.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 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(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 the Federal
Aviation Administration Order 7400.9W, Airspace Designations and
Reporting Points, dated August 8, 2012, and effective September 15,
2012, is amended as follows:

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

* * * * *

ACE IA E5 West Union, IA [Amended]

West Union, George L. Scott Municipal Airport, IA
    (Lat. 42[deg]59'06'' N., long. 91[deg]47'26'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of George L. Scott Municipal Airport.

    Issued in Fort Worth, Texas, on March 15, 2013.
David P. Medina,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2013-06908 Filed 3-27-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 77 (Tuesday, April 22, 2014)]
[Rules and Regulations]
[Pages 22367-22369]
[FR Doc No: 2014-08142]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0042; Directorate Identifier 2013-CE-050-AD;
Amendment 39-17823; AD 2014-07-09]
RIN 2120-AA64

Airworthiness Directives; British Aerospace Regional Aircraft
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for British
Aerospace Regional Aircraft Jetstream Series 3101 and Jetstream Model
3201 airplanes. This AD results from mandatory continuing airworthiness
information (MCAI) issued by an aviation authority of another country
to identify and correct an unsafe condition on an aviation product. The
MCAI describes the unsafe condition as inadequate instructions for
inspection for corrosion on the rudder upper hinge bracket and certain
internal wing and drainage paths. We are issuing this AD to require
actions to address the unsafe condition on these products.

DATES: This AD is effective May 27, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of May 27, 2014.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0042; or in person at Document Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
    For service information identified in this AD, contact BAE Systems
(Operations) Limited, Customer Information Department, Prestwick
International Airport, Ayrshire, KA9 2RW, Scotland, United Kingdom;
telephone: +44 1292 675207; fax: +44 1292 675704; email:
<EMAIL_ADDRESS>Internet: http://www.baesystems.com/Businesses/RegionalAircraft/. You may review this referenced service
information at the FAA, Small Airplane Directorate, 901 Locust, Kansas
City, Missouri 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Taylor Martin, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to British Aerospace Regional
Aircraft Jetstream Series 3101 and Jetstream Model 3201 airplanes. The
NPRM was published in the Federal Register on January 31, 2014 (79 FR
5323). The NPRM proposed to correct an unsafe condition for the
specified products and was based on mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country. The MCAI states:

    Compliance with the inspections in the Corrosion Prevention and
Control Programme (CPCP) has been identified as a mandatory action
for continued airworthiness and UK CAA AD 003-04-94 was issued to
require operators to comply with those inspection instructions.
    Since the issuance of that AD, reports have been received of
finding extensive corrosion on the rudder upper hinge bracket.
Although there is an existing zonal inspection of the area in the
CPCP, it has been concluded that this is inadequate to identify the
corrosion on this bracket and consequently, a new specific
inspection of the rudder upper hinge bracket,

task 200/EX/01 C2, has been added to the CPCP, currently at Revision
6. Failure of the rudder upper hinge bracket could lead to the onset
of flutter and loss of control of the aeroplane.
    In addition, although the CPCP already included a wing internal
inspection to check for corrosion and to verify that all drainage
paths are clear, prompted by feedback from the fleet sampling
programme, a new, more specific, inspection of wing stations 36, 51
and 83, together with a check of the drainage paths, has been
introduced into the CPCP through task 3/400/IN/01 C2. Failure to
comply with these instructions could result in an unsafe condition.
    For the reasons described above, this AD retains the
requirements of UK CAA AD 003-04-94, which is superseded, and
requires the implementation of the new inspections.

    The MCAI can be found in the AD docket on the Internet at: http://www.regulations.gov/#!documentDetail;D=FAA-2014-0042-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (79 FR 5323, January 31,
2014) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting the AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 5323, January 31, 2014) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 5323, January 31, 2014).

Costs of Compliance

    We estimate that this AD will affect 66 products of U.S. registry.
We also estimate that it would take about 100 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour.
    Based on these figures, we estimate the cost of the AD on U.S.
operators to be $561,000, or $8,500 per product.
    The scope of damage found in the required inspection could vary
significantly from airplane to airplane. We have no way of determining
how much damage may be found on each airplane or the cost to repair
damaged parts on each airplane or the number of airplanes that may
require repair.

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.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will 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 AD:
    (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.

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-2014-
0042; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains the NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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 AD:

2014-07-09 British Aerospace Regional Aircraft: Amendment 39-17823;
Docket No. FAA-2014-0042; Directorate Identifier 2013-CE-050-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective May 27,
2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to British Aerospace Regional Aircraft Jetstream
Series 3101 and Model 3201 airplanes, all serial numbers,
certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 5: Time Limits.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as inadequate
instructions for inspection for corrosion on the rudder upper hinge
bracket and certain internal wing stations and drainage paths. We
are issuing this AD to prevent, detect, and correct corrosion on the
rudder upper hinge bracket and internal wing, which could lead to
reduced structural integrity of the airplane with consequent loss of
control.

(f) Actions and Compliance

    Comply with this AD within the compliance times specified in
paragraphs (f)(1) through (f)(4) of this AD, including all
subparagraphs, unless already done:
    (1) After May 27, 2014 (the effective date of this AD), except
as required by paragraph (f)(2) of this AD, within the thresholds
and intervals specified, incorporate into the FAA-approved
maintenance program BAE Systems (Operations) Limited Jetstream
Series 3100 & 3200 Corrosion Prevention and Control Programme,
Manual Ref. JS/CPCP/01, Revision 6, dated November 15, 2010, in its
entirety.
    (2) Within 2 years after May 27, 2014 (the effective date of
this AD), do the initial inspections specified in tasks 200/EX/01 C2
and 3/400/IN/01 C2 in BAE Systems (Operations) Limited Jetstream
Series 3100 &

3200 Corrosion Prevention and Control Programme, Manual Ref. JS/
CPCP/01, Revision 6, dated November 15, 2010.
    (3) If any discrepancy, particularly corrosion, is found during
any inspections or tasks required by paragraphs (f)(1) and (f)(2) of
this AD, within the compliance time specified, repair or replace, as
applicable, all damaged structural parts and components and do the
maintenance procedures for corrective action following BAE Systems
(Operations) Limited Jetstream Series 3100 & 3200 Corrosion
Prevention and Control Programme, Manual Ref. JS/CPCP/01, Revision
6, dated November 15, 2010. If no compliance time is defined, do the
applicable corrective action before further flight.
    (4) You may comply with the requirements of paragraphs (f)(1)
and (f)(2) of this AD by incorporating BAE Systems (Operations)
Limited Jetstream Series 3100 & 3200 Corrosion Prevention and
Control Programme, Manual Ref. JS/CPCP/01, Revision 6, dated
November 15, 2010, into your maintenance program (instructions for
continued airworthiness) and complying with that program.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Taylor Martin, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any
airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(h) Related Information

    MCAI European Aviation Safety Agency (EASA) AD No.: 2012-0036,
dated March 12, 2012, for related information. The MCAI can be found
in the AD docket on the Internet at: http://www.regulations.gov/#!documentDetail;D=FAA-2014-0042-0002.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) BAE Systems (Operations) Limited Jetstream Series 3100 &
3200 Corrosion Prevention and Control Programme, Manual Ref: JS/
CPCP/01, Revision 6, dated November 15, 2010.
    (ii) Reserved.
    (3) For British Aerospace Regional Aircraft service information
identified in this AD, contact BAE Systems (Operations) Limited,
Customer Information Department, Prestwick International Airport,
Ayrshire, KA9 2RW, Scotland, United Kingdom; telephone: +44 1292
675207; fax: +44 1292 675704; email<EMAIL_ADDRESS>
Internet: http://www.baesystems.com/Businesses/RegionalAircraft/.
    (4) You may view this service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on April 4, 2014.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2014-08142 Filed 4-21-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 187 (Monday, September 28, 2015)]
[Notices]
[Pages 58328-58329]
[FR Doc No: 2015-24562]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2011-0177]
RIN 2105-AD96

30-Day Notice of Application for New Information Collection
Request OMB No. 2105-XXXX: Nondiscrimination on the Basis of Disability
in Air Travel

AGENCY: Office of the Secretary (OST), Department of Transportation
(Department) or (DOT).

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995 (44
U.S.C. chapter 35, as amended), this notice announces that the
Department of Transportation's (DOT) Office of the Secretary (OST) is
submitting a request to the Office of Management Budget (OMB) for
approval of the new information collections described below. On
November 12, 2013, the Department gave 60 day notice of its intent to
obtain OMB control numbers authorizing the new information collections
in its final rule amending the Air Carrier Access Act (ACAA)
implementing regulation, 14 CFR part 382 (part 382), Nondiscrimination
on the Basis of Disability in Air Travel. The purpose of this notice is
to allow for an additional 30 days of public comment.

DATES: Comments on this notice must be received by October 28, 2015.

ADDRESSES: Your comments should be identified by Docket No. DOT-OST-
2011-0177 and may be submitted through one of the following methods:
     Office of Management and Budget, Attention: Desk Officer
for U.S. Department of Transportation, Office of the Secretary of
Transportation, 725 17th Street NW., Washington, DC 20503,
     email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Maegan L. Johnson or Blane A. Workie,
Office of the General Counsel, Office of the Secretary, U.S. Department
of Transportation, 1200 New Jersey Avenue SE, Washington, DC, 20590,
202-366-9342 (Voice),<PHONE_NUMBER> (Fax), or<EMAIL_ADDRESS>(Email). Arrangements to receive this document in an alternative format
may be made by contacting the above-named individuals.

SUPPLEMENTARY INFORMATION:
    Background: The ACAA, 49 U.S.C. 41705, prohibits discriminatory
treatment of persons with disabilities in air transportation. On
November 12, 2013, the Department published a final rule amending its
ACAA regulation, 14 CFR part 382, to require airlines to ensure that
the public facing Web pages on their primary Web sites are accessible
to individuals with disabilities. 78 FR 67882 (November 12, 2013).
Covered carriers are U.S. and foreign air carriers that operate at
least one aircraft having a designed seating capacity of more than 60
passengers and own or control a primary Web site that markets passenger
air transportation or a tour, or tour component that must be purchased
with air transportation, to the general public in the United States.\1\

The final rule established two new information collection requirements
that are the subject of this notice. First, by December 12, 2015,
carriers must provide an online mechanism for passengers to request
disability accommodation services (e.g., enplaning/deplaning
assistance, deaf/hard of hearing communication assistance, escort to
service animal relief area, etc.) for a particular flight. Second, by
December 12, 2016, carriers must ensure that when a user activates a
link on a carrier's primary Web site to embedded third-party software
or to an external Web site, a disclaimer is displayed notifying the
user that the application or Web site may not be accessible. In the
preamble of the final rule, the Department described and invited
interested persons to submit comments on any aspect of these new
information collections for 60 days. The Department received no
comments on the information collections. This 30 notice is intended to
give the public additional time to comment.
---------------------------------------------------------------------------

    \1\ While there are approximately 175 U.S. and foreign air
carriers that conduct passenger-carrying service to, from, or in the
United States with at least one aircraft having a designed seating
capacity of more than 60 seats, not all of those carriers have a
primary Web site that markets passenger air transportation to the
general public in the U.S. After conducting a sample review of
carrier Web sites, the Department estimates that approximately 135
of those 175 carriers are subject to the Department's Web-
accessibility requirements.
---------------------------------------------------------------------------

1. Online Request for Disability Accommodation

    Type of Request: This is a new information collection.
    Form Number: There are no OST forms associated with this
collection.
    Description of the need for the information and proposed use: Each
carrier will provide a mechanism on its Web site for passengers to
request a disability accommodation service for a future flight and
provide advance notice of their request. Carriers may, but need not,
require passengers to include contact information on the form in order
to follow-up and request more specific information about the
passengers' accommodation needs. Carriers may also use the aggregate
data from the online service requests to understand and better plan for
the volume and types of service requests they receive across time
periods and routes, but also are not required to do so.
    While the content and design of the online service request form is
up to the carriers, the Department anticipates that each covered U.S.
and foreign carrier that markets scheduled air transportation to the
general public in the United States would incur initial costs
associated with developing and reviewing a design and implementation
plan for the request form, developing, coding, and integrating the form
into the Web site, as well as testing, debugging, and connecting the
form with a backend database to store the information. The revised
final regulatory analysis (FRA) estimated that it will take an average
of 32 labor hours per carrier to develop, implement, integrate,
connect, and test the online request form. Should carrier associations
or some other entity develop a common request form that all carriers
could adapt and incorporate to their Web sites, the initial costs per
carrier would be reduced.
    Respondents: Certificated U.S. and foreign air carriers operating
to, from, and within the United States that operate at least one
aircraft having a seating capacity of more than 60 passengers and own
or control a primary Web site that markets air transportation to the
general public in the U.S.
    Estimated Number of Respondents: 135 U.S. and foreign carriers.
    Estimated Annual Burden on Respondents: 32 hours..
    Estimated Total Annual Burden: 4,320 hours.
    Frequency: One-time requirement.

2. Web Site Accessibly Disclaimer Notice

    Type of Request: This is a new information collection.
    Form Number: There are no OST forms associated with this
collection.
    Description of the need for the information and proposed use:
    In order to be in conformance with the accessibility standard
required by the final DOT rule, carriers must provide a disclaimer
notice for each link on their primary Web site that enables a user to
access software or an external Web site that is not in the carrier's
control. The disclaimer notice must be activated the first time a user
clicks the link and must notify the user that the application/Web site
is not within the carrier's control and may not follow the same
accessibility policies as the primary Web site. The Department
anticipates that each covered U.S. and foreign carrier that markets
scheduled air transportation to the general public in the United States
will incur costs associated with identifying all links on their Web
sites that may require a disclaimer such as developing and reviewing
the design and language for the disclaimer notice, as well as
developing, testing, and deploying the code to the appropriate Web
pages.
    The incremental labor hours associated with providing the required
disclaimer may vary depending on the number of links on the Web site to
which this requirement applies. The FRA estimated that it will take an
average of 6 labor hours per carrier to identify the links and then
develop, test, and deploy the disclaimer notice on the Web site.
    Estimated Number of Respondents: 135 U.S. and foreign carriers.
    Estimated Annual Burden on Respondents: 6 hours.
    Estimated Total Burden: 810 hours.
    Frequency: One-time requirement.

    Issued in Washington, DC, on September 21, 2015.
Claire W. Barrett,
Chief Privacy & Information Asset Officer.
[FR Doc. 2015-24562 Filed 9-25-15; 8:45 am]
BILLING CODE 4910-9X-P