[Federal Register Volume 78, Number 14 (Tuesday, January 22, 2013)]
[Notices]
[Pages 4418-4419]
[FR Doc No: 2013-01164]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1255]

Electronic Submission Process for Requesting Export Certificates
From the Center for Devices and Radiological Health; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of an electronic submission process for requesting export
certificates for products regulated by FDA's Center for Devices and
Radiological Health (CDRH). The electronic process will help fulfill
both the legislative and application time processing requirements set
out by the FDA Export Reform and Enhancement Act of 1996 and the terms
of clearance of the Office of Management and Budget approval (OMB
control number 0910-0498) of the Form FDA 3613 series. The new
eSubmitter process will complement the current paper-based process.

FOR FURTHER INFORMATION CONTACT: Leila Lawrence, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 2668, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. How eSubmitter Impacts FDA's Current Process

    FDA currently accepts requests for export certificates submitted by
mail. This process will remain in place and would be augmented by the
new eSubmitter process.
    For general user assistance, contact the Center for Devices and
Radiological Health (CDRH), Division of Small Manufacturers,
International and Consumer Assistance (DSMICA) by telephone: 1-800-638-
2041 or<PHONE_NUMBER>; or by email<EMAIL_ADDRESS>    You can find information about FDA's Electronic Submissions Gateway
online at: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. Email questions about the system to FDA's Electronic
Submissions Gateway Help Desk<EMAIL_ADDRESS>
II. Background on the Electronic Submission of Requests for Export
Certificates

    FDA introduces an electronic option for submitting requests for
export certificates of devices regulated by CDRH as a voluntary
alternative to paper submissions. With electronic submissions, CDRH can
more readily receive and process the export requests.
    The electronic process will be introduced in two phases. In the
first phase of operation, the CDRH Export Certification Application and
Tracking System (CECATS) will be made available to industry for the
electronic submission of requests for export certificates.
    CECATS is a Web-based application used by FDA's CDRH to process,
manage, and administer certificates for the export of medical devices.
CDRH will be implementing the electronic submission and review process.
Industry will have an option to submit electronically or via the paper
process. CECATS will be accessible through the FDA Unified Registration
and Listing System (FURLS). A firm must have a FURLS account to access
CECATS.
    The CECATS module is a part of the FURLS application within the FDA
Industry Systems Portal utilized to automatically issue the certificate
to U.S. medical device manufacturers/distributors who wish to export
their medical devices to foreign countries.
    CECATS will help fulfill both the legislative and application time
processing requirements set out by the FDA Export Reform and
Enhancement Act of 1996 (Public Law 104-134) and the terms of clearance
of the OMB approval of the Form FDA 3613 series.
    CECATS will provide industry the option of submitting export
requests electronically. Electronic submission will automate many of
the steps that both industry and CDRH must perform to submit and
process export certificates. The advantages to industry will be:
     Certificate processing time will be greatly reduced;
     Automated real-time validation will eliminate the need to
return submissions; and
     Industry will receive real-time updates on the status of
their requests via the Web.
    In early 2013, FDA will implement phase two for the remainder of
the export certification, notification, and permit requests listed as
follows:
     Certificates of Exportability (sections 801(e)(1) and 802
of the FD&C Act);
     Non-Clinical Research Use Only Certificate;
     Simple Notifications (section 802(g) of the FD&C Act); and
     Export Permit Letter (section 801(e)(2) of the FD&C Act).
    Upon full implementation in 2013, industry will be able to submit
all export requests electronically. This is a ``win'' for both industry
and CDRH as it will allow us to process all export requests more
efficiently and expeditiously. CDRH is developing webinars and will
hold online training sessions with industry on how to access and use
CECATS. A schedule and detailed instructions will be sent to industry
and posted to our Web site at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExportingDevices/ucm050521.htm#ref when they become available.
    Evaluation of the electronic submission process will be conducted
periodically to further enhance both user interface and data collection
needs as they become known to FDA. Electronic submissions of requests
for export certificates will remain voluntary at this time.
    The printable forms can be viewed at the following links:
     Form FDA 3613: Supplementary Information Certificate for
Foreign Government Requests<EMAIL_ADDRESS>     Form FDA 3613a: Supplementary Information Certificate of
Exportability Requests<EMAIL_ADDRESS>     Form FDA 3613c: Supplementary Information Non-Clinical
Research Use Only Certificate<EMAIL_ADDRESS>
III. What happens when the new eSubmitter process for requesting export
certificates is implemented?

    Implementation of the eSubmitter process will supplement the
ability to request export certificates from CDRH via paper. The new
Web-based application (available at: https://www.access.fda.gov/oaa/index.jsp) uses your existing FURLS account

information. The Web site provides an alternative to the paper request
process by enabling online submission of export certificate
applications.

IV. Paperwork Reduction Act of 1995

    This document refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in CECATS and
Forms FDA 3613, 3613a, and 3613c have been approved under OMB control
number 0910-0498.

    Dated: January 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01164 Filed 1-18-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: July 28, 2008 (Volume 73, Number 145)]
[Notices]
[Page 43731]
[DOCID:fr28jy08-36]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13162-000]

BPUS Generation Development LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

July 21, 2008.
    On April 2, 2008, BPUS Generation Development LLC filed an
application, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Sylvan Slough Hydroelectric
Project to be located on Sylvan Slough on the Mississippi River in Rock
Island County, Illinois. The project would be located near the U.S.
Army Corps of Engineers' Mississippi Lock & Dam No. 15 and would occupy
federal lands under the jurisdiction of the U.S. Army, Rock Island
Arsenal Garrison.
    The proposed project would consist of: (1) A new 200-foot long,
120-foot wide, 60-foot high powerhouse; (2) three turbine/generator
units with a total installed capacity of 7.5 megawatts; (3) a
transmission line; and (4) appurtenant facilities. The project is
estimated to have an annual generation of 40 gigawatt-hours, which
would be sold to a local utility.
    Applicant Contact: David W. Culligan, BPUS Generation Development
LLC, 225 Greenfield Parkway, Suite 201, Liverpool, NY 13088; Phone:
315-413-2821. FERC Contact: Henry Woo,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``eFiling'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of the Commission's Web site at http:/
/www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13162) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-17150 Filed 7-25-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 50 (Friday, March 14, 2014)]
[Notices]
[Pages 14595-14596]
[FR Doc No: 2014-05650]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms and Record Keeping Requirements; Agency
Information Collection Activity Under OMB Review

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

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstract regarding the Uniform Tire Quality
Grading Standard (UTQGS) below has been forwarded to the Office of
Management and Budget (OMB) for review and comment. The ICR describes
the nature of the information collections and their expected burden.
The Federal Register Notice with a 60-day comment period was published
on November 29, 2013 [78 FR 71714]. The agency received one comment to
the 60 day notice.

DATES: Comments must be submitted on or before April 14, 2014.

FOR FURTHER INFORMATION CONTACT: Mr. Hisham Mohamed at the National
Highway Traffic Safety Administration, Office of International Policy,
Fuel Economy and Consumer Programs (NVS-131), 1200 New Jersey Ave. SE.,
W43-437, Washington, DC 20590. Mr. Mohamed's telephone number is (202)
366-0307.

SUPPLEMENTARY INFORMATION:

National Highway Traffic Safety Administration

    Title: 49 CFR Part 575.104; Uniform Tire Quality Grading Standard
    OMB Number: 2127-0519.
    Type of Request: Extension of a currently approved information
collection.
    Abstract: Part 575 requires tire manufacturers and tire brand name
owners to submit reports to NHTSA regarding the UTQGS grades of all
passenger car tire lines they offer for sale in the United States. This
information is used by consumers of passenger car tires to compare tire
quality in making their purchase decisions. The information is provided
in several different ways to insure that the consumer can readily see
and understand the tire grades: (1) The grades are molded into the
sidewall of the tire so that they can be reviewed on both the new and
old tires; (2) a paper label is affixed to the tread face of the new
tires that provides the grades of that particular tireline along with
an explanation of the grading system; (3) the tire manufacturer or
brand name owner provides prospective purchasers of tires the
information for each tire offered for sale at the particular location;
(4) vehicle manufacturers include in the owner's manual of each vehicle
the grade information for the tires with which the vehicle is equipped;
(5) NHTSA compiles the grading information of all manufacturers'
tirelines into a booklet that is available to the public both in
printed form and on NHTSA's Web site.
    Affected Public: All passenger car tire manufacturers and brand
name owners offering passenger car tires for sale in the United States.

    Estimated Total Annual Burden: NHTSA estimates that a cost of
approximately $35.1 million to tire manufacturers and brand name owners
is required to comply with this regulation.

ADDRESSES: Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725-17th
Street NW., Washington, DC 20503, Attention NHTSA Desk Officer.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Departments' estimate of the burden of the
proposed information collection; ways to enhance the quality, utility,
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology. Comments to OMB are most effective if OMB
receives them within 30 days of publication.

David M. Hines,
Director, Office of Crash Avoidance Standards.
[FR Doc. 2014-05650 Filed 3-13-14; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Page 9252]
[FR Doc No: 2014-03497]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2013-0045; OMB No. 1660-0047]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Request for Federal Assistance Form--How to
Process Mission Assignments in Federal Disaster Operations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before March 20, 2014.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 1800 South Bell Street, Arlington, VA
20598-3005, facsimile number<PHONE_NUMBER>, or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Collection of Information

    Title: Request for Federal Assistance Form---How to Process Mission
Assignments in Federal Disaster Operations.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0047.
    FEMA Forms: FEMA Form 010-0-7, Resource Request Form; FEMA Form
010-0-8, Mission Assignment.
    Abstract: If, during the course of a State's response to a
disaster, the State determines that its capacity to respond exceeds its
available resources, a request to FEMA for assistance can be made. This
request documents how the response requirements exceed the capacity for
the State to respond to the situation on its own and what type of
assistance is required. FEMA reviews this information and can task
other Federal Agencies with a mission assignment to assist the State in
its response to the situation.
    Affected Public: State, local or Tribal Government.
    Estimated Number of Respondents: 10.
    Estimated Total Annual Burden Hours: 2,453 hours.
    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $139,060.57. There are no annual costs to respondents
operations and maintenance costs for technical services. There is no
annual start-up or capital costs. The cost to the Federal Government is
$36,994.20.

    Dated: February 7, 2014.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2014-03497 Filed 2-14-14; 8:45 am]
BILLING CODE 9110-24-P


[Federal Register: March 24, 2006 (Volume 71, Number 57)]
[Notices]
[Page 14877]
[DOCID:fr24mr06-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-270-000]

Guardian Pipeline, L.L.C.; Notice of Tariff Filing

March 16, 2006.
    Take notice that on March 8, 2006, Guardian Pipeline, L.L.C.
(Guardian) tendered for filing as part of its FERC Gas Tariff, Original
Volume No. 1, First Revised Sheet No. 202A, to become effective April
7, 2006.
    Guardian states that the purpose of this filing is to remove the
tariff provision implementing the Commission's CIG/Granite State policy
as now permitted by the Commission in a March 3, 2005 Order in
Williston Basin Interstate Pipeline Company, Docket No. RP00-463-006
(110 FERC ] 61,210).
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

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

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-4255 Filed 3-23-06; 8:45 am]

BILLING CODE 6717-01-P


From:  Randy Wiler<EMAIL_ADDRESS>Sent: Friday, September 16, 2016 4:39 PM To:  Jones, DonnaLee Cc: Allen Dittenhoefer; Mike Durkin; Paul Saffrin Subject:  Copy of Copy of Coke-Enclosure-1-Questionnaire Answer File_ALL-Part_04 01 16_revAD_090816.xlsx

Dear Dr. Jones,

Please find attached a copy of Enclosure 1.

If you have any questions, please contact the undersigned.

Sincerely Erie Coke Corporation

Randy Wiler Environmental Manager

<< Copy of Copy of Coke-Enclosure-1-Questionnaire Answer File_ALL-Part_04 01 16_revAD_090816.xlsx >>