			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on July 30, 2007

NOTICE OF ACTION TAKEN -- DOCKET OST-2007-28764

________________________________________________________________________
__________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of FRONTIER AIRLINES, INC. (FRONTIER) filed 7/16/07 for:

XX  Exemption for two years under 49 U.S.C. 40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between San Diego, California and Mazatlan, Mexico.  Frontier proposes
to operate these services on a seasonal basis beginning December 15,
2007.

Applicant rep: Edward P. Faberman<PHONE_NUMBER>  DOT Analyst: Thuy H.
Cooper<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The above action was effective when taken: July 30, 2007, through July
30, 2009.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated: XX  Holder’s
certificates of public convenience and necessity

	   XX  Standard Exemption Conditions (attached)

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

Conditions: The U.S.-Mexico exemption authority granted is subject to
the dormancy notice requirements set forth in condition 7 of Appendix A
of Order 88-10-2.  Consistent with our policy, the dormancy notice
period will begin on December 15, 2007, Frontier’s proposed start-up
date for the above-mentioned service.

Remarks: We acted on this application without awaiting expiration of the
15-day answer period with the consent of all parties served with the
application.

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

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted or dismissed, we denied all requests in the
referenced Dockets.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

APPENDIX

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration, the Transportation Security Administration, and with all
applicable U.S. Government requirements concerning security, including,
but not limited to, 49 CFR Part 1544.  To assure compliance with all
applicable U.S. Government requirements concerning security, the holder
shall, before commencing any new service (including charter flights) to
or from a foreign airport, contact its International Principal Security
Inspector (IPSI) to advise the IPSI of its plans and to find out whether
the Transportation Security Administration has determined that security
is adequate to allow such airport(s) to be served;

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with
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[Federal Register: November 10, 2005 (Volume 70, Number 217)]
[Notices]
[Page 68436-68437]
[DOCID:fr10no05-109]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

November 4, 2005.
    Take notice that the Commission received the following electric
rate filings.
    Docket Numbers: ER06-21-000.
    Applicants: Deseret Generation & Transmission Co-operative, Inc.
    Description: Deseret Generation & Transmission Co-operative, Inc's
proposed Wholesale Power Contract Rate Rebate as an amendment to the
jurisdictional service agreement Nos. 1-6 etc, & requests waiver of 60-
day notice requirements.
    Filed Date: October 11, 2005.
    Accession Number: 20051013-0075.
    Comment Date: 5 p.m. Eastern Time on Monday, November 14, 2005.

    Docket Numbers: ER06-94-000.
    Applicants: ISO New England Inc.
    Description: ISO New England, Inc submits revised tariff sheets of
the ISO's transmission, markets and services tariff, in order to
collect its administrative costs for calendar year 2006.
    Filed Date: October 31, 2005.
    Accession Number: 20051102-0283.
    Comment Date: 5 p.m. Eastern Time on Monday, November 21, 2005.

    Docket Numbers: ER06-95-000.
    Applicants: Pacific Gas & Electric Company.
    Description: Pacific Gas and Electric Co's submits Eleventh
Quarterly Filing of Facilities Agreement, Revised Rate Schedule FERC
No. 114.
    Filed Date: October 31, 2005.
    Accession Number: 20051103-0039.
    Comment Date: 5 p.m. Eastern Time on Monday, November 21, 2005.

    Docket Numbers: ER06-97-000.
    Applicants: ISO New England Inc.
    Description: ISO New England, Inc submits its 2006 Capital Budget
Quarterly Filing for third Quarter of 2005 with supporting materials.
    Filed Date: October 31, 2005.
    Accession Number: 20051102-0292.
    Comment Date: 5 p.m. Eastern Time on Monday, November 21, 2005.

    Docket Numbers: ER06-109-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits executed service
agreement for long-term firm point-to-point transmission service w/
Southwestern Public Service Co dba Xcel Energy Marketing as
Transmission Customer.
    Filed Date: October 31, 2005.
    Accession Number: 20051103-0091.
    Comment Date: 5 p.m. Eastern Time on Monday, November 21, 2005.

    Docket Numbers: ER06-110-000; ER06-111-000.
    Applicants: Mirant Delta, LLC; Mirant Potrero, LLC.
    Description: Mirant Delta, LLC et al submits revisions to their
Must-Run Service Agreements with California Independent System Operator
Corp.

    Filed Date: October 31, 2005.
    Accession Number: 20051103-0092.
    Comment Date: 5 p.m. Eastern Time on Monday, November 21, 2005.

    Docket Numbers: ER06-112-000.
    Applicants: Goose Haven Energy Center, LLC.
    Description: Goose Haven Energy Center, LLC submits the revised
rate schedule sheets for the Reliability Must-Run Service Agreement
with California Independent System Operator Corp.
    Filed Date: October 31, 2005.
    Accession Number: 20051103-0093.
    Comment Date: 5 p.m. Eastern Time on Monday, November 21, 2005.

    Docket Numbers: ER06-113-000.
    Applicants: Reliant Energy Etiwanda, Inc.
    Description: Reliant Energy Etiwanda, Inc submits the revised pages
for its FERC Electric Rate Schedule No. 2, Must-Run Service Agreement
with California Independent System Operator Corp.
    Filed Date: October 31, 2005.
    Accession Number: 20051103-0094.
    Comment Date: 5 p.m. Eastern Time on Monday, November 21, 2005.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other and the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E5-6181 Filed 11-9-05; 8:45 am]

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[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Notices]
[Pages 28876-28878]
[FR Doc No: 2016-10924]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1210]

Technical Considerations for Additive Manufactured Devices; Draft
Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Technical
Considerations for Additive Manufactured Devices.'' FDA has developed
this draft leapfrog guidance to provide FDA's initial thoughts on
technical considerations specific to devices using additive
manufacturing, the broad category of manufacturing encompassing 3-
dimensional (3D) printing. Specifically, this draft guidance outlines
technical considerations associated with additive manufacturing
processes, and testing and characterization for final finished devices
fabricated using additive manufacturing. This draft guidance is not
final nor is it in effect at this time.

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 of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 8, 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-2016-D-1210 for ``Technical Considerations for Additive
Manufactured Devices.'' 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.
    An electronic copy of the draft guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the draft guidance. Submit
written requests for a single hard copy of the draft guidance document
entitled ``Technical Considerations for Additive Manufactured Devices''
to the Office of the Center Director, Guidance and Policy Development,
Center for Devices and Radiological Health (CDRH), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002; or the Office of Communication, Outreach, and
Development, Center for Biologics Evaluation and Research (CBER), Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Matthew Di Prima, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 62, Rm. 2214, Silver Spring, MD 20993-0002, 301-
796-2507; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed this draft leapfrog guidance to provide FDA's
initial thoughts on technical considerations specific to devices using
additive manufacturing (AM), the broad category of manufacturing
encompassing 3D printing. In medical device applications, AM has the
advantage of facilitating the creation of anatomically-matched devices
and surgical instrumentation by using a patient's own medical imaging.
Another advantage is the ease in fabricating complex geometric
structures, allowing the creation of engineered open lattice
structures, tortuous internal channels, and internal support structures
that would not be easily possible using traditional (non-additive)
manufacturing approaches. However, the unique aspects of the AM
process, such as the layer-wise fabrication process, and the relative
lack of medical device history of devices manufactured using AM
techniques, pose challenges in determining optimal characterization and
assessment methods for the final finished device, as well as optimal
process validation and verification methods for these devices. To
discuss these challenges and obtain initial stakeholder input, the FDA
held a public workshop entitled ``Additive Manufacturing of Medical
Devices: An Interactive Discussion on the Technical Considerations of
3D Printing,'' on October 8-9, 2014 (http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm397324.htm). When finalized, this
draft guidance document will recommend technical aspects of an
additively manufactured device that should be considered through the
phases of development, production process, process validation, and
final finished device testing.
    This draft guidance is a leapfrog guidance; leapfrog guidances are
intended to serve as a mechanism by which the Agency can share initial
thoughts regarding the content of premarket submissions for emerging
technologies and new clinical applications that are likely to be of
public health importance very early in product development. This
leapfrog guidance represents the Agency's initial thinking, and our
recommendations may change as more information becomes available. The
Agency strongly encourages manufacturers to engage with CDRH and/or
CBER through the Pre-Submission process to obtain more detailed
feedback regarding their AM device or process. For more information on
Pre-Submissions, please see ``Requests for Feedback on Medical Device
Submissions: The Pre-Submission Program and Meetings with Food and Drug
Administration Staff'' (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf).

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on technical
considerations for additive manufactured devices. 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.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all CDRH guidance documents is available at http://
www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov. Persons unable to download
an electronic copy of ``Technical Considerations for Additive
Manufactured Devices'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1400002 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    These collections of information are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR
part 814, subparts B and E are approved under OMB control number 0910-
0231; the collections of information in 21 CFR part 814, subpart H are
approved under OMB control number 0910-0332; the collections of
information in 21 CFR part 807, subpart E are approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
812 are approved under OMB control number 0910-0078; the collections of
information in 21 CFR part 820 are approved under OMB control number
0910-0073; the collections of information in 21 CFR parts 801 and 809
are approved under OMB control number 0910-0485; and the collections of
information in the guidance document entitled ``Requests for Feedback
on Medical Device Submissions: The Pre-Submission Program and Meetings
with Food and Drug Administration Staff'' are approved under OMB
control number 0910-0756.

    Dated: May 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10924 Filed 5-9-16; 8:45 am]
BILLING CODE 4164-01-P