[Federal Register: February 19, 2008 (Volume 73, Number 33)]
[Proposed Rules]
[Page 9060-9062]
[DOCID:fr19fe08-14]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-0037; Airspace Docket No. 07-AWP-6]

Proposed Establishment of Low Altitude Area Navigation Routes (T-
Routes); Sacramento and San Francisco, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish four low altitude Area
Navigation (RNAV) routes, designated T-257, T-259, T-261 and T-263 in
the Sacramento and San Francisco, CA, terminal areas. T-routes are low
altitude Air Traffic Service (ATS) routes, based on RNAV, for use by
aircraft having instrument flight rules (IFR)-approved Global
Positioning System (GPS)/Global Navigation Satellite System (GNSS)
equipment. The FAA is proposing this action to enhance safety and
improve the efficient use of the navigable airspace in the Sacramento
and San Francisco, CA, terminal areas.

DATES: Comments must be received on or before April 4, 2008.

ADDRESSES: Send comments on this proposal to the Docket Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
1200 New Jersey Avenue, SE., West Building Ground Floor, Room W12-140,
Washington, DC 20590-0001; telephone:<PHONE_NUMBER>. You must identify
FAA Docket No. FAA Docket No. FAA-2008-0037 and Airspace Docket No. 07-
AWP-6 at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Ken McElroy, Airspace and Rules Group,
Office of System Operations Airspace and AIM, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA Docket No. FAA-2008-0037 and Airspace Docket No. 07-AWP-6) and be
submitted in triplicate to the Docket Management Facility (see
``ADDRESSES'' section for address and phone number). You may also
submit comments through the Internet at http://www.regulations.gov.

    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA Docket No. FAA-2008-0037 and Airspace Docket No.
07-AWP-6.'' The postcard will be date/time stamped and returned to the
commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. 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 http://www.regulations.gov Recently published rulemaking documents can also be accessed through the FAA's web page at http://.

www.faa.gov or the Federal Register's web page at http://www.gpoaccess.gov/fr/index.html
.

    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. An
informal docket may also be examined during normal business hours at
the office of the Western Service Center, Air Traffic Organization,
Federal Aviation Administration, 1601 Lind Avenue, 15000 SW., Renton,
WA 98055.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

History

Low Altitude RNAV Route Identification and Charting

    Low altitude RNAV routes are identified by the letter ``T'' prefix
followed by a three digit number. The ``T'' prefix is one of several
International Civil Aviation Organization designators used to identify
domestic RNAV routes. The FAA has been allocated the letter ``T''
prefix and the number block 200 to 500 for use in naming these routes.
The FAA uses the ``T'' prefix for RNAV routes in the low altitude en
route structure of the National Airspace System.
    T-routes are depicted in blue on the appropriate IFR en route low
altitude chart(s). Each route depiction includes a GNSS minimum en
route altitude to ensure obstacle clearance and communications
reception.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to establish four low altitude RNAV routes
in the Sacramento and San Francisco, CA, terminal areas. The routes
would be designated T-257, T-259, T-261 and T-263, and would be
depicted on the appropriate IFR En Route Low Altitude charts. T-routes
are low altitude RNAV ATS routes, similar to Very High Frequency
Omnidirectional Range Federal airways, but based on GNSS navigation.
RNAV-equipped aircraft capable of filing flight plan equipment suffix
``G'' may file for these routes.
    The T-routes described in this notice are being proposed to enhance
safety, and to facilitate the more flexible and efficient use of the
navigable airspace for en route IFR operations transitioning through
and around the Sacramento and San Francisco, CA, terminal areas.
    Low altitude RNAV routes are published in paragraph 6011 of FAA
Order 7400.9R signed August 15, 2007 and effective September 15, 2007,
which is incorporated by reference in 14 CFR 71.1. The low altitude
RNAV routes listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation: (1) Is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under Department of Transportation (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 proposed 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 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 the
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 establishes RNAV T-Routes at Sacramento and San Francisco, CA.

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, 311b, and 311k. 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).

The Proposed Amendment

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

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9R, Airspace Designations and Reporting Points, signed August 15,
2007 and effective September 15, 2007, is amended as follows:

Paragraph 6011--Contiguous United States Area Navigation Routes

* * * * *

T-257 Big Sur, CA (BSR) to Point Reyes (PYE) [New]
Big Sur, CA (BSR)...........  VORTAC..............  (Lat. 36[deg]10'53'' N., long. 121[deg]38'32'' W.)
ISIFU.......................  WP..................  (Lat. 36[deg]43'29'' N., long. 121[deg]56'57'' W.)
SUTRO.......................  WP..................  (Lat. 36[deg]42'43'' N., long. 122[deg]32'49'' W.)
Point Reyes, CA (PYE).......  VORTAC..............  (Lat. 38[deg]04'47'' N., long. 122[deg]52'41'' W.)

                                                  * * * * * * *
T-259 Sacramento, CA (SAC) to San Jose, CA (SJC) [New]
Sacramento, CA. (SAC).......  VORTAC..............  (Lat. 38[deg]26'37'' N., long. 121[deg]33'00'' W.)
MOVDD.......................  WP..................  (Lat. 37[deg]39'41'' N., long. 121[deg]26'54'' W.)

CEDES.......................  WP..................  (Lat. 37[deg]33'30'' N., long. 121[deg]37'51'' W.)
San Jose, CA. (SJC).........  VORTAC..............  (Lat. 37[deg]22'29'' N., long. 121[deg]56'41'' W.)

                                                  * * * * * * *
T-261 Woodside, CA (OSI) to ALTAM [New]
Woodside, CA (OSI)..........  VORTAC..............  (Lat. 37[deg]23'33'' N., long. 122[deg]16'55'' W.)
ALTAM.......................  WP..................  (Lat. 37[deg]48'44'' N., long. 121[deg]44'50'' W.)

                                                  * * * * * * *
T-263 Sunol to Scaggs Island, CA (SGD) [New]
SUNOL.......................  WP..................  (Lat. 37[deg]36'20'' N., long. 121[deg]48'37'' W.)
Scaggs Island, CA (SGD).....  VORTAC..............  (Lat. 38[deg]10'46'' N., long. 122[deg]22'23'' W.)

                                                  * * * * * * *

    Issued in Washington, DC on February 8, 2008.
Ellen Crum,
Acting Manager, Airspace and Rules Group.
 [FR Doc. E8-2978 Filed 2-15-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 63 (Friday, April 1, 2022)]
[Notices]
[Pages 19109-19110]
[FR Doc No: 2022-06844]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2022-0002; Internal Agency Docket No. FEMA-B-2227]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP).

DATES: Comments are to be submitted on or before June 30, 2022.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://hazards.fema.gov/femaportal/prelimdownload and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2227, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email) [email protected].

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

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://hazards.fema.gov/femaportal/prelimdownload and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

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

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Marquette County, Michigan (All Jurisdictions)
         Project: 15-05-1490S Preliminary Date: October 19, 2021
------------------------------------------------------------------------
Charter Township of Chocolay...........  Chocolay Charter Township Hall,
                                          5010 US Highway 41 South,
                                          Marquette, MI 49855.
Charter Township of Marquette..........  Township Hall, 1000 Commerce
                                          Drive, Marquette, MI 49855.
City of Ishpeming......................  City Hall, 100 East Division
                                          Street, Ishpeming, MI 49849.
City of Marquette......................  City Hall, 300 West Baraga
                                          Avenue, Marquette, MI 49855.
City of Negaunee.......................  City Hall, 319 West Case
                                          Street, Negaunee, MI 49866.
Township of Champion...................  Township Hall, 5317 US Highway
                                          41 West, Champion, MI 49814.
Township of Ely........................  Ely Township Hall, 1555 County
                                          Road 496, Ishpeming, MI 49849.
Township of Ishpeming..................  Township Hall, 1575 US Highway
                                          41 West, Ishpeming, MI 49849.
Township of Negaunee...................  Township Hall, 42 State Highway
                                          M35, Negaunee, MI 49866.
Township of Powell.....................  Powell Township Hall, 101
                                          Bensinger Street, Big Bay, MI
                                          49808.

Township of Sands......................  Sands Township Office Complex,
                                          987 State Highway M-553,
                                          Gwinn, MI 49841.
Township of Skandia....................  Township Hall, 224 Kreiger
                                          Drive, Skandia, MI 49885.
Township of Tilden.....................  Tilden Township Hall, 3145
                                          County Road PG, Ishpeming, MI
                                          49849.
------------------------------------------------------------------------
          Kanawha County, West Virginia and Incorporated Areas
         Project: 19-03-0002S Preliminary Date: October 25, 2021
------------------------------------------------------------------------
Town of Clendenin......................  Town Hall, 103 First Street,
                                          Clendenin, WV 25045.
Unincorporated Areas of Kanawha County.  Office of the Floodplain
                                          Administrator, 407 Virginia
                                          Street East, Second Floor,
                                          Charleston, WV 23501.
------------------------------------------------------------------------

[FR Doc. 2022-06844 Filed 3-31-22; 8:45 am]
BILLING CODE 9110-12-P


"Tony Nutter"<EMAIL_ADDRESS>06/11/2008 11:28 AM	To
Keith Barnett/RTP/USEPA/US@EPA
cc

bcc

Subject
RE: Cost of Gypsum used in Cement Manufactures

		Keith,
Your assumptions are correct, that should be close to the basic cost per
ton delivered to the plant depending on distance. Do you have a
particular cement plant in mind, I know several plants have wet
scrubbers and produce synthetic gypsum which is used in the cement
grinding process.

-----Original Message-----
From<EMAIL_ADDRESS><EMAIL_ADDRESS>Sent: Wednesday, June 11, 2008 10:21 AM
To: Tony Nutter
Subject: Cost of Gypsum used in Cement Manufactures

Dear Mr. Nutter:

This email is a follow -up to a conversation we had around May 28.  As I
mentioned on the phone, I am working on an EPA project to review certain
air emissions standards for portland cement kilns.  One issue we are
addressing is the use of synthetic gypsum produced by an sulfur dioxide
wet scrubber at a cement facility  to replace mined gypsum.

I was asking about the cost of gypsum that might be purchased by cement
plants in your market area (specifically Texas) to mix with clinker.  In
our conversation you indicated that the cost of gypsum at the mine was
$10.00 per ton.  The main cost to a cement plant would be the freight to
get the gypsum to the plant.  You estimated that freight costs would
vary from $1500 to $2500 for a 100 ton rail car.   By my calculation
that would mean a freight cost of $15 to $25 per ton.  Therefore the
total delivered cost of gypsum to a cement plant in Texas would range
from $25 to $35 per ton.

Could you please confirm my understanding is correct?

Attached is the MSDS for the material we discussed from your website.

(See attached file: MaterialSafetyDataSheet.pdf)

Keith W. Barnett
USEPA/OAQPS/SPPD/MMG
Mail Code D243-02
Research Triangle Park, NC  27711
919-541-5605
<EMAIL_ADDRESS>


[Federal Register Volume 85, Number 101 (Tuesday, May 26, 2020)]
[Notices]
[Page 31537]
[FR Doc No: 2020-11177]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4497-DR; Docket ID FEMA-2020-0001]

Kentucky; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the Commonwealth of Kentucky (FEMA-4497-DR), dated March
28, 2020, and related determinations.

DATES: The declaration was issued March 28, 2020.

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 March 28, 2020, 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 emergency conditions in the
Commonwealth of Kentucky resulting from the Coronavirus Disease 2019
(COVID-19) pandemic beginning on January 20, 2020, and continuing,
are 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 Commonwealth of Kentucky.
    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 assistance for emergency
protective measures (Category B), including direct Federal
assistance, under the Public Assistance program throughout the
Commonwealth. Consistent with the requirement that Federal
assistance be supplemental, any Federal funds provided under the
Stafford Act for Public Assistance will be limited to 75 percent of
the total eligible costs.
    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, Gracia B. Szczech, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the Commonwealth of Kentucky have been
designated as adversely affected by this major disaster:

    Emergency protective measures (Category B) not authorized under
other Federal statutes, including direct Federal assistance, under
the Public Assistance program at 75 percent federal funding for all
areas in the Commonwealth of Kentucky.
    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.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-11177 Filed 5-22-20; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: May 2, 2008 (Volume 73, Number 86)]
[Rules and Regulations]
[Page 24155-24157]
[DOCID:fr02my08-9]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0015; Directorate Identifier 2007-NM-328-AD;
Amendment 39-15498; AD 2008-09-17]
RIN 2120-AA64

Airworthiness Directives; McDonnell Douglas Model DC-10-10, DC-
10-10F, DC-10-15, and MD-10-10F Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
McDonnell Douglas Model DC-10-10, DC-10-10F, DC-10-15, and MD-10-10F
airplanes. This AD requires repetitive inspections for the presence of
stray nickel or chrome plating deposits on the air filler valve bore of
certain main landing gear (MLG) shock strut cylinders, and if
necessary, related investigative and corrective actions. Doing the
corrective action terminates the repetitive inspections. This AD
results from a report of a left MLG collapse during landing rollout. We
are issuing this AD to detect and correct stray nickel and chrome
plating deposits, corrosion, and cracking of the air filler valve bore
on the MLG cylinder, which could result in landing gear failure,
significant damage to the airplane, and injury to personnel.

DATES: This AD is effective June 6, 2008.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 6,
2008.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Long Beach Division, 3855 Lakewood
Boulevard, Long Beach, California 90846, Attention: Data and Service
Management, Dept. C1-L5A (D800-0024).

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; 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 this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the 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 FURTHER INFORMATION CONTACT: Maureen Moreland, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
certain McDonnell Douglas Model DC-10-10, DC-10-10F, DC-10-15, and MD-
10-10F airplanes. That NPRM was published in the Federal Register on
January 14, 2008 (73 FR 2206). That NPRM proposed to require repetitive
inspections for the presence of stray nickel or chrome plating deposits
on the air filler valve bore of certain main landing gear (MLG) shock
strut cylinders, and if necessary, related investigative and corrective
actions. Doing the corrective action would terminate the repetitive
inspections.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received from the commenter.

Support for the NPRM

    The Air Line Pilots Association, International (ALPA), supports the
intent of the NPRM.

Request To Reduce the Compliance Time

    ALPA requests that we reduce the 24-month compliance time for the
airplanes identified in paragraph (f)(2) of the NPRM. ALPA requests the
reduction in compliance time due to the stated severity of a landing
gear failure, the relatively short inspection times, and the low
estimated inspection costs.
    We do not agree to reduce the compliance time specified in
paragraph (f)(2) of this AD. In developing the compliance time for this
AD action, we considered not only the safety implications of the
identified unsafe

condition, but the average utilization rate of the affected fleet, the
practical aspects of an orderly inspection of the fleet during regular
maintenance periods, and the availability of replacement parts. In
addition, we also considered the manufacturer's recommendation for an
appropriate compliance time. After considering all the available
information, we determined that the 24-month compliance time represents
an appropriate interval of time in which the required actions can be
performed in a timely manner within the affected fleet, while still
maintaining an adequate level of safety. However, if additional data
are presented that would justify a shorter compliance time, we might
consider further rulemaking on this issue. We have not changed this AD
in this regard.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting the
AD as proposed.

Costs of Compliance

    We estimate that this AD affects 75 airplanes of U.S. registry. The
following table provides the estimated costs for U.S. operators to
comply with this AD.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                                   Work     Average                                                  U.S.-
             Action               hours    labor rate               Cost per product               registered                  Fleet cost
                                            per hour                                               airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspection.....................        4          $80  $320, per inspection cycle...............           75  $24,000, per inspection cycle.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

    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 that this AD:
    (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) 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.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
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:

2008-09-17 McDonnell Douglas: Amendment 39-15498. Docket No. FAA-
2008-0015; Directorate Identifier 2007-NM-328-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective June 6, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to McDonnell Douglas Model DC-10-10, DC-10-
10F, DC-10-15, and MD-10-10F airplanes, certificated in any
category; as identified in Boeing Alert Service Bulletin DC10-
32A259, dated October 30, 2007.

Unsafe Condition

    (d) This AD results from a report of a left main landing gear
(MLG) collapse during landing rollout. We are issuing this AD to
detect and correct stray nickel and chrome plating deposits,
corrosion, and cracking of the air filler valve bore on the MLG
cylinder, which could result in landing gear failure, significant
damage to the airplane, and injury to personnel.

Compliance

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

Inspections and Corrective Actions

    (f) At the applicable time specified in paragraph (f)(1),
(f)(2), or (f)(3) of this AD, do a video probe inspection for the
presence of stray nickel or chrome plating deposits on the air
filler valve bore of the MLG shock strut cylinders, and before
further flight, do all applicable related investigative and
corrective actions, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin DC10-32A259, dated
October 30, 2007. Repeat the video probe inspection thereafter at
intervals not to exceed 2,400 flight cycles or 20 months, whichever
occurs first. Accomplishment of the repair specified in Part 2 of
the Accomplishment Instructions of the service bulletin or the
replacement specified in Part 3 of the Accomplishment Instructions
of the service bulletin terminates the repetitive inspections for
that MLG shock strut cylinder.
    (1) For passenger airplanes: Within 24 months after the
effective date of this AD.
    (2) For freighter airplanes with MLG cylinders that have
accumulated fewer than 7,200 flight cycles in a freighter
configuration as of the effective date of this AD: Within 24 months
after the effective date of this AD.
    (3) For freighter airplanes with MLG cylinders that have
accumulated 7,200 flight cycles or more in a freighter configuration
as of the effective date of this AD: Within 6 months after the
effective date of this AD.

Parts Installation

    (g) As of the effective date of this AD, no person may install a
MLG shock strut cylinder assembly, part number ARG7002-1, -501, -
503, or -505, on any airplane, unless the air filler valve bore hole
has been oversized and closing action has been accomplished in
accordance with Boeing Alert Service Bulletin DC10-32A259, dated
October 30, 2007, and the MLG shock strut cylinder assembly has been
permanently identified with part number SB10320259-3 adjacent to the
existing ARG7002 part number.

Alternative Methods of Compliance (AMOCs)

    (h)(1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, ATTN: Maureen Moreland, Aerospace Engineer, Airframe
Branch, ANM-120L, Los Angeles ACO, 3960 Paramount Boulevard,
Lakewood, California 90712-4137; telephone<PHONE_NUMBER>; fax (562)
627-5210; has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
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.

Material Incorporated by Reference

    (i) You must use Boeing Alert Service Bulletin DC10-32A259,
dated October 30, 2007, to do the actions required by this AD,
unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Long Beach Division, 3855 Lakewood
Boulevard, Long Beach, California 90846, Attention: Data and Service
Management, Dept. C1-L5A (D800-0024).
    (3) You may review copies of the service information
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, Washington; or 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/code_of_federal_
regulations/ibr_locations.html.

    Issued in Renton, Washington, on April 18, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-9439 Filed 5-1-08; 8:45 am]

BILLING CODE 4910-13-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA/ OECA/ OC/ CAMPD 2. OMB control number b. G None a. 2 0 6 0  0 0 02 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NSPS for Asphalt Processing and Asphalt Roofing Manufacture, Subpart UU  Reporting and recordkeeping requirements.

8. Agency form number( s) ( If applicable) 0661.06 9. Keywords Air pollution, Pollution Control, Environmental Monitoring, Pollution Monitoring 10. Abstract Owners and operators must notify EPA of construction, modification, startups, shutdowns, malfunctions, and data and results of performance test. Owners/ operators must continually monitor and record temperature in specified pollution control devices. EPA determines parameters to be recorded in other control devices upon description of that device by the source. No excess emission reports are required.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 83 b. Total annual responses 10 1. Percentage of these responses collected electronically 0%_______________ c. Total annual hours requested 15, 089 d. Current OMB inventory 15, 629 e. Difference  540 f. Explanation of difference 1. Program Change 2. Adjustment  540 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 200 b. Total annual costs ( O& M) 2905 c. Total annualized cost requested 3105 d. Current OMB inventory 3,210 e. Difference  105 f. Explanation of difference 1. Program change 2. Adjustment  105 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. x Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. X Other ( describe) Initial Reports 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Gregory Fried Phone: ( 202) 564 7016 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

© It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information ( OEI) Date OMB 83 I 10/ 95


[Federal Register: April 11, 2006 (Volume 71, Number 69)]
[Notices]
[Page 18321-18322]
[DOCID:fr11ap06-90]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepting for Filing and Soliciting Motions
To Intervene, Protests and Comments

April 5, 2006.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12615-000.
    c. Date filed: September 29, 2005.
    d. Applicant: Alaska Power & Telephone Company.
    e. Name of Project: Soule River Water Project.
    f. Location: On the Soule River, within the Ketchikan Recording
District, First Judicial District, near Hyder, AK. The project would be
on federal land within the Tongass National Forest.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Robert S. Grimm, President, Alaska Power
& Telephone Company, P.O. Box 3222, Port Townsend, WA 98368, (360) 385-
1733 x 120.
    i. FERC Contact: Etta Foster,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Please include the project
number (P-12615-000) on any comments, protests, or motions filed.
    k. Description of Project: The proposed project would consist of:
(1) A proposed concrete dam with a maximum height of 150-200 feet; (2)
a proposed storage reservoir with a normal water surface area of 917
acres, a gross storage capacity of approximately 74,000 acre-feet and
an active storage capacity of approximately 60,000 acre-feet; (3) a
proposed 12-foot-diameter, 12,100-foot-long tunnel; (4) a proposed
powerhouse containing 2 generating units with a total installed
capacity of 42 MW; (5) an open channel tailrace; (6) a 35-kV submarine
cable approximately 9.72 miles long connected to an interconnection
with the existing transmission system in Hyder, and (7) appurtenant
facilities.
    The project would have an estimated annual generation of
approximately 155 giga-watt hours. The applicant plans to sell the
capacity and generated energy either to BC Hydro, or an electric
utility in the United States after wheeling over the BC Hydro
transmission system.
    l. Location of Application: A copy of the application is available
for inspection and reproduction at the Commission in the Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item
h. above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR
4.30(b) and 4.36.
    o. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30(b) and 4.36.
    p. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions to Intervene: Anyone may submit

comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents: Any filings must
bear in all capital letter the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', ``MOTION TO INTERVENE'',
``NOTICE OF INTENT'', or ``COMPETING APPLICATION'', as applicable, and
the Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. A copy of any motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    t. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-5305 Filed 4-10-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Proposed Rules]
[Pages 66847-66848]
[FR Doc No: 2015-27707]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2014-D-1584]

Same Surgical Procedure Exception: Questions and Answers
Regarding the Scope of the Exception; Draft Guidance for Industry;
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening the
comment period for the draft document entitled ``Same Surgical
Procedure Exception: Questions and Answers Regarding the Scope of the
Exception; Draft Guidance for Industry'' announced in the Federal
Register of October 23, 2014. FDA is reopening the comment period to
allow interested persons

additional time to submit comments and any new information.

DATES: Submit either electronic or written comments on the draft
guidance by April 29, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions''.
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-1584 for ``Same Surgical Procedure Exception: Questions and
Answers Regarding the Scope of the Exception; Draft 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.

FOR FURTHER INFORMATION CONTACT: Lori J. Churchyard, 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.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 23, 2014 (79 FR 63348), FDA
announced the availability of a draft document entitled ``Same Surgical
Procedure Exception under 21 CFR 1271.15(b): Questions and Answers
Regarding the Scope of the Exception; Draft Guidance for Industry''
dated October 2014. The draft guidance is intended for tissue
establishments and health care professionals and discusses one of the
exceptions for establishments from certain regulatory requirements.
Interested persons were originally given until December 22, 2014, to
comment on the draft guidance.
    Elsewhere in this issue of the Federal Register, FDA is announcing
four other related documents. In a separate document, FDA is announcing
a public hearing entitled ``Draft Guidances Relating to the Regulation
of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public
Hearing; Request for Comments'' (part 15 hearing) to be held on April
13, 2016, to provide stakeholders with the opportunity to discuss FDA's
policy on regulation of human cells, tissues, and cellular and tissue-
based products (HCT/Ps) related to the four draft guidances on the
following topics: Homologous use, same surgical procedure exception,
minimal manipulation, and adipose tissue.
    In a separate document, FDA is announcing the availability of a
draft document entitled ``Homologous Use of Human Cells, Tissues, and
Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA
Staff.''
    In separate documents, FDA is also reopening the comment periods to
FDA's public dockets on the previously issued draft guidance documents
on the following topics related to HCT/Ps: Minimal manipulation (Docket
No. FDA-2014-D-1696) and adipose tissue (Docket No. FDA-2014-D-1856).

II. Reopening of Comment Period

    Following publication of the October 23, 2014, notice of
availability, FDA received a request to allow interested persons
additional time to comment. In conjunction with the part 15 hearing and
announcement of availability of the homologous use draft guidance, FDA
is reopening the comment period to allow potential respondents to
thoroughly evaluate and address pertinent issues. The same surgical
procedure exception draft guidance and other related guidances
(homologous use, minimal manipulation, adipose tissue) all deal with
the interpretation of the regulations under 21 CFR part 1271 that will
be addressed as part of the part 15 hearing.

    Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27707 Filed 10-29-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42604-42605]
[FR Doc No: 2015-17506]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2013-0066; Notice 2]

Ford Motor Company, Grant of Petition for Decision of
Inconsequential Noncompliance

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

ACTION: Grant of petition.

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SUMMARY: Ford Motor Company (Ford) has determined that certain model
year (MY) 2013 Ford Fusion and Lincoln MKZ passenger cars built from
August 12, 2012 through January 14, 2013 do not fully comply with
paragraph S<IP_ADDRESS>(a) of Federal Motor Vehicle Safety Standard (FMVSS)
No. 102 Transmission Shift Position Sequence, Starter Interlock, and
Transmission Braking Effect, or paragraph S5.2.1 of FMVSS No. 114 Theft
Protection and Rollaway Prevention. Ford has filed an appropriate
report dated March 4, 2013, pursuant to 49 CFR part 573, Defect and
Noncompliance Responsibility and Reports.

ADDRESSES: For further information on this decision contact Amina
Fisher, Office of Vehicle Safety Compliance, the National Highway
Traffic Safety Administration (NHTSA), telephone<PHONE_NUMBER>,
facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    I. Overview: Pursuant to 49 U.S.C. 30118(d) and 30120(h) and the
rule implementing those provisions at 49 CFR part 556, Ford has
petitioned for an exemption from the notification and remedy
requirements of 49 U.S.C. Chapter 301 on the basis that this
noncompliance is inconsequential to motor vehicle safety.
    Ford submitted its petition on March 21, 2013. On February 11,
2014, Ford submitted a petition supplement to clarify how the specific
vehicles affected do not fully comply with FMVSS No. 102 and FMVSS No.
114.
    Notice of receipt of the petition was published, with a 30-day
public comment period, on March 3, 2014, in the Federal Register (79 FR
11871.) No comments were received. To view the petition and all
supporting documents log onto the Federal Docket Management System
(FDMS) Web site at: http://www.regulations.gov/. Then follow the online
search instructions to locate docket number ``NHTSA-2013-0066.''
    II. Vehicles Involved: Affected are approximately 4,727 MY 2013
Ford Fusion and Lincoln MKZ passenger cars built from August 12, 2012
through January 14, 2013 at the Hermosillo Stamping and Assembly Plant
(HSAP) in Hermosillo, Mexico.
    III. Noncompliance: Ford has determined that because the affected
vehicles were inadvertently shipped to dealers in the ``Factory Mode''
instead of ``Transport Mode,'' the transmission gear selected in
relation to other gears is not always displayed by the shift position
sequence indicator (aka, PRNDL) as required by paragraph S<IP_ADDRESS>(a) of
FMVSS No. 102. In addition, the affected Ford Fusion vehicles
manufactured with mechanical key ignition systems do not fully meet the
requirements of paragraph S5.2.1 of FMVSS No. 114 because under certain
conditions the mechanical key may be removed from the ignition lock
cylinder when the transmission shift lever is in a position other than
``park.''
    IV. Rule Text: Paragraph S<IP_ADDRESS>(a) of FMVSS No. 102 specifically
states:

    S<IP_ADDRESS> Except as specified in S<IP_ADDRESS>, if the transmission
shift position sequence includes a park position, identification of
shift positions, including the positions in relation to each other
and the position selected, shall be displayed in view of the driver
whenever any of the following conditions exist:
    (a) The ignition is in a position where the transmission can be
shifted; . . .

    Paragraph S5.2.1 of FMVSS No. 114 specifically states:

    S5.2.1 Except as specified in S5.2.3, the starting system
required by S5.1 must prevent key removal when tested according to
the procedures in S6, unless the transmission or gear selection
control is locked in ``park'' or becomes locked in ``park'' as a
direct result of key removal.

    V. Summary of Ford's Analyses: Ford stated its belief that the
subject noncompliance is inconsequential to motor vehicle safety for
the following reasons:
    1. The vehicle design is self-remedying. The affected vehicles are

designed to automatically switch from Factory Mode to Transport Mode
after 60 key cycles (beginning with assembly line initialization). Once
in Transport Mode the vehicles are fully compliant with FMVSS
requirements.
    2. While in Factory Mode, affected vehicles clearly display the
message ``Factory Mode Contact Dealer'' in either the message center or
instrument cluster. Additionally, the ``Factory Mode Contact Dealer''
message does not obscure any regulatory malfunction indicator lamps, or
(non-mandated) cautionary warnings.
    3. The dealership's Pre-Delivery Inspection instructions require
dealerships to change the vehicle into Customer Mode, prior to
delivery, which ensures the condition will be remedied before delivery
to the customer. Ford is not aware of any of the subject vehicles being
delivered to customers in Factory Mode.
    4. All other requirements of FMVSS No. 102 and FMVSS No. 114 are
fully satisfied.
    5. Ford is not aware of any owner complaints, accidents, or
injuries attributed to this condition.
    Ford has additionally informed NHTSA that it has corrected the
noncompliance so that all future vehicles will comply with FMVSS Nos.
102 and 114.
    In summation, Ford believes that the described noncompliance of the
subject vehicles is inconsequential to motor vehicle safety, and that
its petition, to exempt from providing recall notification of
noncompliance as required by 49 U.S.C. 30118 and remedying the recall
noncompliance as required by 49 U.S.C. 30120 should be granted.

VI. NHTSA Decision

    NHTSA's Analysis of Ford's Arguments: Ford stated that while in
Factory Mode, affected vehicles clearly display the message ``Factory
Mode--Contact Dealer'' in a manner that does not obscure any regulatory
malfunction indicator lamps. If a consumer were to receive a vehicle in
Factory Mode the aforementioned warning message will alert the driver
in a clear manner. The consumer would then most likely contact the
dealer, as instructed, who would provide remedy for the condition. If
the consumer chose not to contact the dealer, the FMVSS No. 102
noncompliance of not displaying shift positions would only occur when
the engine is not running and the battery voltage falls below 12.3
volts. The PRNDL shift level positions will be properly illuminated
whenever the engine is running under both stationary and moving
conditions.
    With regards to the FMVSS No. 114 noncompliance Ford stated that
while in Factory Mode the mechanical key may be removed from the
ignition lock cylinder when the transmission shift lever is in a
position other than ``park'' if the engine is not running and the CAN
network has entered a hibernation mode after approximately 15 seconds
of total vehicle electrical inactivity. When a consumer turns their
vehicle off they are likely to remove the mechanical key from the
cylinder prior to the vehicle reaching 15 seconds of total electrical
inactivity. Removing the key prior to these 15 seconds would prevent
the vehicle from experiencing a condition noncompliant to FMVSS No. 114
as it would require the transmission control to be shifted to ``park''
before key removal.
    Ford stated that dealerships have Pre-Delivery Inspection
instructions which require them to change vehicles from Transport Mode
to Customer Mode.\1\ During this inspection, if the dealership finds
any of the subject vehicles in the Factory Mode the mode will be
changed directly to the Customer Mode. Actions taken by the dealership
during the pre-delivery inspection will ensure noncompliant vehicles
are remedied prior to delivery to the customer. These instructions from
the manufacturer to their dealerships will help to prevent consumers
from receiving vehicles not in Customer Mode.
---------------------------------------------------------------------------

    \1\ According to Ford, both Transport and Customer Modes are
fully compliant with all FMVSS No. 102 and FMVSS No. 114
requirements. The only difference between the two modes is the
automatic timing set for placing the vehicle into its ``Battery
Saver'' condition. In the Transport Mode the battery saver condition
occurs after 1 minute of inactivity to minimize battery drain during
transport from the OEM factory to the vehicle dealership, whereas,
in the Customer Mode the battery saver condition occurs after ten
minutes of inactivity, the timing is extended for customer
conveniences while parked. Ford also explained that if the vehicle
were to be inadvertently left in the Transport Mode upon delivery to
the customer, the vehicle would automatically shift to the Customer
Mode after 50-62 miles.
---------------------------------------------------------------------------

    Lastly, Ford states that the vehicle is designed to be self-
remedying and will automatically switch from Factory Mode to the fully
compliant Transport Mode after 60 key cycles. If a consumer were to
receive a vehicle in Factory Mode and decided to ignore the warning
message, their vehicle would automatically switch to a fully compliant
mode after the required number of key cycles.
    We believe that drivers of the affected vehicles will be
sufficiently alerted by the message on the instrument cluster which
reads ``Factory Mode--Contact Dealer''. Furthermore, if they choose to
ignore this message, the vehicle is designed to be self-remedying after
60 ignition key cycles. Considering the unique conditions involved with
these noncompliances, and Ford's statement about the lack of associated
complaints, accidents or injuries related to the affected vehicles,
Ford's noncompliance is considered inconsequential.
    NHTSA's Decision: In consideration of the foregoing, NHTSA has
decided that Ford has met its burden of persuasion that the
noncompliance described is inconsequential to motor vehicle safety.
Accordingly, Ford's petition is hereby granted and Ford is exempted
from the obligation of providing notification of, and remedy for the
subject noncompliances.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, this decision
only applies to the 4,727 vehicles that Ford no longer controlled at
the time it determined that the noncompliance existed. However, the
granting of this petition does not relieve vehicle distributors and
dealers of the prohibitions on the sale, offer for sale, or
introduction for delivery or introduction into interstate commerce of
the noncompliant vehicles under their control after Ford notified them
that the subject noncompliance existed.

    Authority: 49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8.

Jeffrey Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2015-17506 Filed 7-16-15; 8:45 am]
 BILLING CODE 4910-59-P