[Federal Register: September 24, 2009 (Volume 74, Number 184)]
[Notices]
[Page 48731-48733]
[DOCID:fr24se09-49]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8955-1; Docket ID No. EPA-HQ-ORD-2009-0115]

Draft Toxicological Review of 1,1,2,2-Tetrachloroethane: In
Support of the Summary Information in the Integrated Risk Information
System (IRIS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period and listening session.

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SUMMARY: EPA is announcing a public comment period and a public
listening session for the external review draft document titled,
``Toxicological Review of 1,1,2,2-Tetrachloroethane: In Support of
Summary Information on the Integrated Risk Information System (IRIS)''
(EPA/635/R-09/001). The draft document was prepared by the National
Center for Environmental Assessment (NCEA) within the EPA's Office of
Research and Development (ORD). The public comment period and the
external peer-review workshop, which will be scheduled at a later date
and announced in the Federal Register, are separate processes that
provide opportunities for all interested parties to comment on the
document. EPA intends to forward the public comments that are submitted
in accordance with this notice to the external peer-review panel prior
to the

meeting for their consideration. When finalizing the draft document,
EPA intends to consider any public comments that EPA receives in
accordance with this notice.
    EPA is also announcing a listening session to be held on October
14, 2009, during the public comment period for this draft document.
This listening session is a step in EPA's revised IRIS process,
announced on May 21, 2009, to develop human health assessments for
inclusion in the IRIS database. The purpose of the listening session is
to allow all interested parties to present scientific and technical
comments on draft IRIS health assessments to EPA and other interested
parties during the public comment period and before the external peer
review meeting. EPA welcomes the scientific and technical comments that
will be provided to the Agency by the listening session participants.
The comments will be considered by the Agency as it revises the draft
assessment in response to the independent external peer review and the
public comments. All presentations will become part of the official
public record.
    EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This document has not been formally disseminated by EPA. It
does not represent and should not be construed to represent any Agency
policy or determination.

DATES: The public comment period begins September 24, 2009, and ends
November 23, 2009. Technical comments should be in writing and must be
received by EPA by November 23, 2009.
    The listening session on the draft IRIS health assessment for
1,1,2,2-tetrachloroethane will be held on October 14, 2009, beginning
at 9 a.m. and ending at 4 p.m., Eastern Daylight Time. If you want to
make a presentation at the listening session, you should register by
October 7, 2009, indicate that you wish to make oral comments at the
session, and indicate the length of your presentation. When you
register, please indicate if you will need audio-visual aid (e.g., lap
top and slide projector). In general, each presentation should be no
more than 30 minutes. If, however, there are more requests for
presentations than the allotted time allows, then the time limit for
each presentation will be adjusted. A copy of the agenda for the
listening session will be available at the meeting. If no speakers have
registered by October 7, 2009, the listening session will be cancelled
and EPA will notify those registered of the cancellation.
    Listening session participants who want EPA to share their comments
with the external peer reviewers should also submit written comments
during the public comment period using the detailed and established
procedures described in the SUPPLEMENTARY INFORMATION section of this
notice. Comments submitted to the docket prior to the end of the public
comment period will be submitted to the external peer reviewers and
considered by EPA in the disposition of public comments. All comments
must be submitted to the docket, but comments received after the public
comment period closes will not be submitted to the external peer
reviewers.

ADDRESSES: The draft ``Toxicological Review of 1,1,2,2-
Tetrachloroethane: In Support of Summary Information on the Integrated
Risk Information System (IRIS)'' is available primarily via the
Internet on the NCEA home page under the Recent Additions and
Publications menus at http://www.epa.gov/ncea. A limited number of
paper copies are available from the Information Management Team, NCEA;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>. If you are requesting
a paper copy, please provide your name, mailing address, and the
document title.
    Comments may be submitted electronically via http://
www.regulations.gov, by mail, by facsimile, or by hand delivery/
courier. Please follow the detailed instructions as provided in the
SUPPLEMENTARY INFORMATION section of this notice.
    The listening session on the draft 1,1,2,2-Tetrachloroethane
assessment will be held at the EPA offices at Two Potomac Yard (North
Building), 7th Floor, Room 7100, 2733 South Crystal Drive, Arlington,
Virginia 22202. To attend the listening session, register by October 7,
2009, via e-mail at<EMAIL_ADDRESS>(subject line: 1,1,2,2-
Tetrachloroethane listening session), by phone:<PHONE_NUMBER> or toll
free at<PHONE_NUMBER> or by faxing a registration request<PHONE_NUMBER>
(please reference the ``1,1,2,2-Tetrachloroethane Listening Session''
and include your name, title, affiliation, full address and contact
information). Please note that to gain entrance to this EPA building to
attend the meeting, attendees must have photo identification with them
and must register at the guard's desk in the lobby. The guard will
retain your photo identification and will provide you with a visitor's
badge. At the guard's desk, attendees should give the name Christine
Ross and the telephone number,<PHONE_NUMBER>, to the guard on duty. The
guard will contact Ms. Ross who will meet you in the reception area to
escort you to the meeting room. When you leave the building, please
return your visitor's badge to the guard and you will receive your
photo identification.
    A teleconference line will also be available for registered
attendees/speakers. The teleconference number is<PHONE_NUMBER> and the
access code is<PHONE_NUMBER>, followed by the pound sign ().
The teleconference line will be activated at 8:45 am, and you will be
asked to identify yourself and your affiliation at the beginning of the
call.
    Information on Services for Individuals with Disabilities: EPA
welcomes public attendance at the ``1,1,2,2-Tetrachloroethane Listening
Session'' and will make every effort to accommodate persons with
disabilities. For information on access or services for individuals
with disabilities, please contact Christine Ross at<PHONE_NUMBER> or
<EMAIL_ADDRESS>To request accommodation of a disability,
please contact Ms. Ross, preferably at least 10 days prior to the
meeting, to give EPA as much time as possible to process your request.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>    For information on the public listening sessions, please contact
Christine Ross, IRIS Staff, National Center for Environmental
Assessment, (8601P), U.S. EPA, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>;
or e-mail<EMAIL_ADDRESS>    If you have questions about the document, contact Martin Gehlhaus,
National Center for Environmental Assessment (NCEA), 1200 Pennsylvania
Ave., 8601P, Washington, DC 20460; telephone:<PHONE_NUMBER>; facsimile:
703-347-8689; or e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About IRIS

    IRIS is a database that contains potential adverse human health
effects information that may result from chronic (or lifetime) exposure
to specific chemical substances found in the environment. The database
(available on the Internet at http://www.epa.gov/iris) contains
qualitative and quantitative health effects information for more than

540 chemical substances that may be used to support the first two steps
(hazard identification and dose-response evaluation) of a risk
assessment process. When supported by available data, the database
provides oral reference doses (RfDs) and inhalation reference
concentrations (RfCs) for chronic health effects, and oral slope
factors and inhalation unit risks for carcinogenic effects. Combined
with specific exposure information, government and private entities can
use IRIS data to help characterize public health risks of chemical
substances in a site-specific situation and thereby support risk
management decisions designed to protect public health.

II. How To Submit Technical Comments to the Docket at http://
www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2009-
0115 by one of the following methods:
     http://www.regulations.gov: Follow the online instructions
for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center's Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Such deliveries are only accepted during
the docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information. If you provide comments by
mail or hand delivery, please submit one unbound original with pages
numbered consecutively, and three copies of the comments. For
attachments, provide an index, number pages consecutively with the
comments, and submit an unbound original and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2009-0115. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at http://
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-
mail. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://
www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the
EPA Headquarters Docket Center.

    Dated: August 21, 2009.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. E9-22909 Filed 9-23-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Pages 72935-72950]
[FR Doc No: 2011-30450]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0264]

Amended Authorization of Emergency Use of Doxycycline Hyclate
Tablet Emergency Kits for Eligible United States Postal Service
Participants and Their Household Members; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the Emergency Use Authorization (EUA) (the Authorization)
for doxycycline hyclate tablet emergency kits for eligible United
States Postal Service (USPS) participants in the Cities Readiness
Initiative (CRI) and their household members issued on October 3, 2008,
as amended on February 25, 2009, and on August 23, 2010, under the
Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by
the Biomedical Advanced Research and Development Authority (BARDA),
Office of the Assistant Secretary for Preparedness and Response (ASPR),
Department of Health and Human Services (HHS). Following issuance of
FDA's August 23, 2010, amended Authorization letter, on April 8, 2011,
BARDA submitted a request on behalf of ASPR to further amend the
Authorization to reflect certain programmatic changes, including by
replacing references to the CRI with the National Postal Model (NPM).
In response to BARDA's request, FDA amended the Authorization letter
and reissued the Authorization in its entirety on October 14, 2011. The
Authorization, as amended and reissued, includes explanations for its
reissuance and is reprinted in this document.

DATES: The amended Authorization is effective as of October 14, 2011.

ADDRESSES: Submit written requests for single copies of the EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4121, Silver
Spring, MD 20993. Send one self-addressed adhesive label to assist that
office in processing your request or include a fax number to which the
Authorization may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Luciana Borio, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 4280, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Amendment to the October 3, 2008, Authorization for Doxycyline
Hyclate Tablet Emergency Kits, as Amended

    In 2004, the Secretary of the Department of Homeland Security (DHS)
issued a material threat determination indicating that Bacillus
anthracis (B. anthracis), the biological agent that causes anthrax
disease, presents a material threat against the

population of the United States sufficient to affect national security.
On September 23, 2008, under section 564(b)(1)(A) of the FD&C Act (21
U.S.C. 360bbb-3(b)(1)(A)), as amended by the Project BioShield Act of
2004 (Pub. L. 108-276), the Secretary of DHS determined that there is a
significant potential for a domestic emergency involving a heightened
risk of attack with a specific biological, chemical, radiological, or
nuclear agent or agents--in this case, B. anthracis. On October 1,
2008, under section 564(b) of the FD&C Act, and on the basis of such
determination, the Secretary of HHS then declared an emergency
justifying the authorization of the emergency use of doxycycline
hyclate tablets accompanied by emergency use information subject to the
terms of any authorization issued under section 564(a) of the FD&C Act,
and on October 1, 2009, and on October 1, 2010, renewed the
declaration. On July 20, 2011, the Secretary of HHS renewed and amended
the declaration to apply to all oral formulations of doxycycline,
including doxycycline hyclate tablets covered by the Authorization,
accompanied by emergency use information subject to the terms of any
authorization issued under section 564(a) of the FD&C Act. Notice of
the declaration of the Secretary was published in the Federal Register
of July 27, 2011 (76 FR 44926).
    On October 1, 2008, BARDA requested and on October 3, 2008, FDA
issued an EUA for doxycycline hyclate tablet emergency kits for
eligible USPS participants in the CRI and their household members,
subject to the terms and conditions of the Authorization. As required
under section 564(h)(1) of the FD&C Act, in the Federal Register of
October 21, 2008 (73 FR 62507), FDA published the Authorization for
doxycycline tablet emergency kits for eligible USPS participants in the
CRI and their household members, including an explanation of the
reasons for its issuance. On February 19, 2009, BARDA submitted a
request on behalf of ASPR to amend the Authorization to make certain
changes to the written information authorized to accompany the
doxycycline hyclate tablet emergency kits and to clarify the roles and
responsibilities provided for in the Authorization. On February 25,
2009, in response to BARDA's request, FDA amended the Authorization
letter and reissued the Authorization letter in its entirety. In the
Federal Register of June 26, 2009 (74 FR 30577), FDA published the
amended Authorization, including an explanation of the reasons for the
amendment. On August 4, 2010, BARDA requested that the EUA be further
amended to permit the use of a certain manufacturer and a certain
repackager under the EUA. On August 23, 2010, in response to BARDA's
request, FDA amended the Authorization letter and reissued the
Authorization letter in its entirety. On April 8, 2011, BARDA requested
that the EUA be further amended to reflect programmatic and operational
changes, including by replacing references to the CRI with the NPM,
clarifying roles and responsibilities, and revising or removing certain
written materials provided for in the Authorization. On October 14,
2011, in response to BARDA's request, FDA amended the Authorization
letter and reissued the Authorization letter in its entirety.

II. Electronic Access

    An electronic version of this document and the full text of the
Authorization are available on the Internet at http://www.regulations.gov.

III. The Authorization

    Having concluded that the criteria for issuance of the
Authorization under section 564(c) of the FD&C Act were met, on October
3, 2008, FDA authorized the emergency use of doxycycline hyclate tablet
emergency kits for eligible USPS participants in the CRI and their
household members subject to the terms and conditions of the
Authorization. The letter of Authorization in its entirety (not
including the amended authorized versions of the fact sheets and other
written materials), as amended on February 25, 2009, on August 23,
2010, and on October 14, 2011, follows and provides an explanation of
the reasons for its amendment.

    Dated: November 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
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[FR Doc. 2011-30450 Filed 11-25-11; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Notices]
[Pages 25761-25762]
[FR Doc No: 2011-11026]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2006-25756]

Commercial Driver's License (CDL) Standards; Volvo Trucks North
America, Renewal of Exemption

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA renews an exemption from the requirement to hold a
commercial driver's license (CDL) sought by Volvo Trucks North America
(Volvo) on behalf of five employees. Volvo requested renewal of the CDL
exemption for five Swedish engineers employed by the company to enable
these individuals to continue test-driving commercial motor vehicles
(CMVs) in the United States. All hold valid Swedish CDLs. FMCSA
believes that the training program and knowledge and skills testing
that drivers must undergo to obtain a Swedish CDL ensure a level of
safety equivalent to, or greater than, the level of safety that would
be obtained by complying with the U.S. requirement for a CDL.

DATES: Comments must be received on or before June 6, 2011. Effective
date of the exemption is April 23, 2011 to April 23, 2013.

ADDRESSES: You may submit comments identified by Federal Docket
Management System Number FMCSA-2006-25756 by any of the following
methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. In the ENTER KEYWORD OR ID box enter FMCSA-2006-
25756 and click on the tab labeled SEARCH. On the ensuing page, click
on any tab labeled SUBMIT A COMMENT on the extreme right of the page
and a page should open that is titled ``Submit a Comment.'' You may
identify yourself under section 1, ENTER INFORMATION, or you may skip
section 1 and remain anonymous. You enter your comments in section 2,
TYPE COMMENT & UPLOAD FILE. When you are ready to submit your comments,
click on the tab labeled SUBMIT. Your comment is then submitted to the
docket; and you will receive a tracking number.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building, Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building, Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.
ET, Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number. For detailed instructions on submitting comments and
additional information on the exemption process, see the Public
Participation heading below. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments received, go to www.regulations.gov at any time, and in the
ENTER KEYWORD OR ID box enter FMCSA-2006-25756 and click on the tab
labeled SEARCH.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19476) or you may visit www.regulations.gov.
    Public Participation: The www.regulations.gov Web site is generally
available 24 hours each day, 365 days each year. You can get electronic
submission and retrieval help and guidelines under the ``help'' section
of the www.regulations.gov Web site and also at the DOT's http://docketsinfo.dot.gov Web site. If you want us to notify you that we
received your comments, please include a self-addressed, stamped
envelope or postcard or print the acknowledgement page that appears
after submitting comments online.

FOR FURTHER INFORMATION CONTACT: Ms. Christine Hydock, FMCSA Driver and
Carrier Operations Division, Office of Bus and Truck Standards and
Operations, Telephone:<PHONE_NUMBER>. E-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the CDL requirements of 49 CFR 383.23 for a maximum 2-year period
if it finds ``such exemption would likely achieve a level of safety
that is equivalent to, or greater than, the level that would be
achieved absent such exemption.'' The procedures for requesting an
exemption (including renewals) are prescribed in 49 CFR part 381.

Volvo Application for Exemption Renewal

    Volvo applied for a 2-year renewal of an exemption from 49 CFR
383.23, the CDL requirement for drivers operating CMVs, for Johnny
Adolfsson, Goran Alsen, Freddy Blixt, Peter Hofsten, and Lars Svensson.
A copy of the request for renewal, dated November 10, 2010, is in the
docket identified at the beginning of this notice.
    FMCSA initially granted an exemption to seven Swedish engineers and
technicians employed by Volvo on May 5, 2009 (74 FR 20778). Detailed
information about the qualifications and experience of each of the
seven drivers, including the five affected by this notice, was provided
by Volvo in its original application, a copy of which is in the docket
referenced above. Volvo is seeking a renewal of this exemption because
the five drivers are citizens and residents of Sweden, and cannot
easily obtain a non-resident CDL, given the small number of States
willing to issue such a license. Renewal of the exemption will enable
them to operate CMVs in the U.S. and continue to support Volvo's field
tests to meet future clean air standards, to test drive prototype
vehicles at its test site, and to deliver the vehicles, if necessary.
It is estimated that they will drive a combined total of approximately
20,800 miles per year on U.S. roads. The applicants are experienced CMV
operators holding valid Swedish-issued CDLs. They have received
extensive CMV training, and have satisfied strict regulations in Sweden
in order to obtain a CDL. Volvo explained in detail in earlier
exemption requests the rigorous training program and knowledge and
skills tests that applicants for a Swedish CDL must undergo. Volvo also
argued that the Swedish knowledge and skills tests and training program
ensure that its drivers operating under the exemption will achieve a
level of safety that is equivalent to, or greater than, the level of
safety obtained by complying with the U.S. requirement for a CDL.

Method To Ensure an Equivalent or Greater Level of Safety

    FMCSA has previously determined that the process for obtaining a
Swedish CDL is comparable to, or as effective as, the requirements of
Part 383, and adequately assesses the driver's ability to operate CMVs
in the U.S. In recent years FMCSA has granted similar Volvo exemption
requests, most recently on August 9, 2010 (75 FR 45198).

Granting of Exemption Renewal

    FMCSA has evaluated Volvo's application for exemption renewals for
Johnny Adolfsson, Goran Alsen, Freddy Blixt, Peter Hofsten, and Lars
Svensson and decided to grant them for an additional 2-year extension,
i.e. from April 23, 2011 to April 23, 2013. These exemptions are
renewed subject to the following terms and conditions: (1) This
exemption is valid only when the drivers are acting within the scope of
their employment by Volvo; (2) the drivers and Volvo must adhere to
drug and alcohol regulations, including testing, as provided by in 49
CFR part 382; (3) the drivers and Volvo must adhere to driver
disqualification rules under 49 CFR parts 383 and 391 that apply to all
CMV drivers in the United States; (4) the drivers are subject to all
other provisions of the Federal Motor Carrier Safety Regulations
(FMCSRs) (49 CFR parts 390-397) unless specifically exempted herein;
(5) the drivers must keep a copy of the exemption on the vehicle at all
times for presentation to a duly authorized Federal, State, or local
enforcement official; (6) Volvo must notify FMCSA in writing of any
accident, as defined in 49 CFR 390.5, involving an exempted driver; and
(7) Volvo must notify FMCSA in writing if an exempted driver is
convicted of a disqualifying offense described in sections 383.51 or
391.15 of the FMCSRs.
    These exemptions will be valid for 2 years unless revoked earlier
by FMCSA. The exemptions will be revoked if: (1) The drivers fail to
comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

Request for Comments

    In accordance with 49 U.S.C. 31315(b)(4), FMCSA requests public
comment on the renewal of the exemption from the requirements of 49 CFR
383.23 for Johnny Adolfsson, Goran Alsen, Freddy Blixt, Peter Hofsten,
and Lars Svensson. The Agency requests that interested parties with
specific data concerning these individuals' safety records submit
comments by June 6, 2011. FMCSA will review all comments received by
this date and determine whether renewal of the exemption is consistent
with the requirements of 49 U.S.C. 31136(e) and 31315. As indicated
above, the Agency has previously determined that providing an exemption
for these Volvo drivers does not compromise the level of safety that
would exist if the exemption were not granted. Interested parties or
organizations possessing information that would show that any of these
individuals are not currently achieving the requisite statutory level
of safety should immediately notify FMCSA. The Agency will evaluate any
adverse information submitted and, if safety is being compromised or if
the continuation of the exemption is not consistent with 49 U.S.C.
31136(e) and 31315(b)(4), FMCSA will take immediate steps to revoke the
exemption.

    Issued on: April 26, 2011.
Larry W. Minor,
 Associate Administrator for Policy and Program Development.
[FR Doc. 2011-11026 Filed 5-4-11; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 80, Number 164 (Tuesday, August 25, 2015)]
[Notices]
[Pages 51567-51568]
[FR Doc No: 2015-20948]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2048]

Medical Device Epidemiology Network Registry Task Force Report;
Availability, Web Site Location and Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the report and Web site location where the Agency has
posted the report entitled ``Recommendations for a National Medical
Device Evaluation System: Strategically Coordinated Registry Networks
to Bridge the Clinical Care and Research,'' developed by the Medical
Device Epidemiology Network's Medical Device Registry Task Force. In
addition, FDA has established a docket where stakeholders may provide
comments.

DATES: Submit either electronic or written comments by October 26,
2015.

ADDRESSES: Submit electronic comments on this document to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Danica Marinac-Dabic, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4110, Silver Spring, MD 20993-0002,
301-796-6689, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA's Center for Devices and Radiological Health is responsible for
protecting the public health by assuring the safety and effectiveness
of medical devices and radiation-emitting products. A key part of this
mission is to monitor medical devices and radiological products for
continued safety and effectiveness after they are in use and to help
the public get the accurate, science-based information they need to
improve their health.
    In September 2012, the FDA published a report, ``Strengthening Our
National System for Medical Device Postmarket Surveillance,'' that
proposed

a strategy for improving the current system for monitoring medical
device safety and effectiveness. In April 2013, the FDA issued an
update to the September 2012 report that incorporated public input
received and described the next steps towards fulfilling the vision for
building a national postmarket surveillance system. These reports can
be found at FDA's Web site http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm.
    One of these next steps consisted of establishing a
multistakeholder Medical Device Registry Task Force to promote the
development of national and international device registries for
selected products (Ref. 1). Under a cooperative agreement with the FDA,
Duke University convened the Medical Device Registry Task Force as a
part of the Medical Device Epidemiology Network public-private
partnership in 2014. The Task Force membership included representatives
from a broad array of stakeholder groups and areas of expertise
including patients, provider organizations, hospitals, health plans,
industry, government agencies, as well as methodologists and academic
researchers.
    The Medical Device Registry Task Force was charged to: (1) Identify
existing registries that may contribute to the system; (2) leverage
ongoing registry efforts focused on quality improvement, reimbursement,
patient-centered outcomes and other activities to best meet the needs
of multiple stakeholders; (3) identify priority medical device types
for which the establishment of a longitudinal registry is of
significant public health importance; (4) define registry governance
and data quality practices that promote rigorous design, conduct,
analysis, and transparency to meet stakeholder needs; and (5) develop
strategies for the use of registries to support premarket approval and
clearance (Ref. 1).
    This notice announces the availability and Web site location of the
Medical Device Registry Task Force's report, entitled ``Recommendations
for a National Medical Device Evaluation System: Strategically
Coordinated Registry Networks to Bridge the Clinical Care and
Research.'' FDA invites interested persons to submit comments on this
report. We have established a docket where comments may be submitted
(see ADDRESSES). We believe this docket is an important tool for
receiving feedback on this report from interested parties and for
sharing this information with the public. To access ``Recommendations
for a National Medical Device Evaluation System: Strategically
Coordinated Registry Networks to Bridge the Clinical Care and
Research'' report, visit FDA's Web site http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm.

II. Request for Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Reference

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday. We have
verified the Web site address, but we are not responsible for
subsequent changes to the Web site after this document publishes in the
Federal Register.

    1. ``Strengthening Our National System for Medical Device
Postmarket Surveillance: Update and Next Steps,'' April 2013,
available at http://www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSurveillance/UCM348845.pdf.

    Dated: August 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20948 Filed 8-24-15; 8:45 am]
 BILLING CODE 4164-01-P


	INFORMATION COLLECTION REQUEST (ICR)

	SUPPORTING STATEMENT

	ENVIRONMENTAL PROTECTION AGENCY

	STRATOSPHERIC OZONE PROTECTION

1.   Identification of Information Collection

a)   Title: Information on Exposure to n-Propyl Bromide under the
Significant New Alternatives Policy (SNAP) Program

b)   Short Characterization

Title VI of the Clean Air Act Amendments of 1990 (the Act) implements
the obligation of the United States under the Montreal Protocol to phase
out the use of ozone-depleting substances.  Section 612 of Title VI
establishes as U.S. policy the requirement that Class I and Class II
ozone-depleting substances shall be replaced, to the maximum extent
practicable, by chemicals, product substitutes, or alternative
manufacturing processes that reduce overall risks to human health and
the environment.

EPA developed its Significant New Alternatives Policy (SNAP) program to
fulfill the requirements of Section 612.  Section 612(c) requires EPA to
enact rules making it unlawful to replace any Class I or II substance
with any substitute that the Administrator determines may present
adverse effects to human health or the environment where an alternative
has been identified that (1) reduces the overall risk to human health
and the environment, and (2) is currently or potentially available.

Section 612(c) also requires EPA to publish a list of the substitutes
prohibited for specific uses.  EPA must publish a corresponding list of
acceptable alternatives for specific uses as well.

EPA issued regulations on March 18, 1994, in 59 FR 13043, which are
codified at 40 CFR Part 82, Subpart G (Section 82.170 et seq.),
establishing the SNAP program.  Information required to be collected
under previous SNAP regulations is currently approved by OMB for use
through October 31, 2007 under OMB control number 2060-0266.

In the most recent proposed rule prepared for the SNAP program, EPA
does not propose any information collection requirements.  The proposal
would allow the use of n-propyl bromide without restriction in solvent
cleaning, would address its use only in a single facility using coatings
with n-propyl bromide, and would prohibit the use of n-propyl bromide in
aerosols and adhesives.

The proposal also mentions and takes comment on the rejected option of
listing the chemical n-propyl bromide as an acceptable substitute
subject to use conditions that users of n-propyl bromide in aerosol
solvents and adhesives must (1) meet a workplace exposure limit of no
more than 17 ppm on an 8-hour time-weighted average, (2) must monitor
workers for exposure initially and periodically, and (3) must keep
records of worker exposure for up to three years from the date of
measurement.  Periodic monitoring would normally be performed every six
months for facilities where all measurements during initial monitoring
are at or below the workplace exposure limit of 17 ppm.  Periodic
monitoring may be eliminated if all measurements during initial testing
are at 10 ppm or below.  In addition, EPA took comments on provisions
that would require new monitoring if major changes occur that could
increase exposure.  The recordkeeping requirement is for the purpose of
demonstrating compliance with the regulatory requirement for exposure.
End users would need to keep records to demonstrate that workers are not
being exposed in excess of the exposure limit.  Because this requirement
is not explicitly listed in the currently approved ICR for the entire
SNAP program, and in order to give the public an opportunity to comment
on the burden of a potential regulatory option, EPA is requesting
approval for this additional ICR.  The burden estimate only applies to
an option for comment, and not to the proposed regulation.

2.   Need for and Use of the Collection

a)   Authority for the Collection

Information required to be collected under the SNAP program is intended
to fulfill the mandate in Section 612(c) of identifying acceptable
substitutes that can serve as replacements for ozone-depleting
substances being phased out under the Act, as well as unacceptable
substances which may not be used as replacements for ozone-depleting
substances being phased out under the Act.  EPA is proposing to
determine that n-propyl bromide may be used without restriction in
solvent cleaning, may be used by a single user of coatings, and must not
be used in aerosol solvents or adhesives.  The Agency also provides for
comment an option that would find n-propyl bromide acceptable subject to
meeting regulatory use conditions for aerosols and adhesives, because if
n-propyl bromide exposures exceed the exposure limit, it is more
hazardous to public health than other alternatives available.  The
proposed regulation for listing of n-propyl bromide is listed in
Appendix A.  Section 612 (42 U.S.C. 7671k) is attached as Appendix B.
EPA(s implementing regulations (40 CFR Part 82, Subpart G, Sect. 82.170
et seq.) are attached as Appendix C.

b)   Use/Users of the Data

EPA's Regional offices and Office of Enforcement and Compliance
Assurance would use the data to determine compliance with the regulatory
use condition.  In addition, users would benefit from the information
because they can determine if further steps are necessary to protect
workers.

3.   Non-duplication, Consultations, and Other Collection Criteria

a)   Non-duplication

The specific information requested by this notice is not currently
collected by EPA or any other government agency. In some cases,
suppliers of n-propyl bromide assist their customers in obtaining
exposure data; these data could be used to meet the requirements of the
rule to avoid duplication with information available in the private
sector.

b)   Consultations

In preparing to prepare this information collection request, EPA
reviewed information for a similar requirement under other federal
regulations (29 CFR 1910.1052(d)).  EPA also consulted with the
Occupational Safety and Health Administration (OSHA) for guidance on
exposure monitoring.

c)   Effects of Less Frequent Collection

If information were collected less frequently, it would not be possible
to determine if the end user is in compliance. Further, users of
n-propyl bromide will be at greater risk of adverse health effects if
they do not know their workplace exposure levels.

EPA mentions two approaches to the use conditions that reduce the total
data collection burden.  One allows relief from periodic monitoring
requirements for a user that demonstrates low exposure at their facility
(8.5 ppm or less).  The other allows for representative sampling of
workers using n-propyl bromide, rather than sampling of every exposed
worker.

d)   General Guidelines

This rule does not exceed any of the guidelines.

e)   Confidentiality and Sensitive Questions

i)   Confidentiality

The physical records that end users keep on file are not readily
available to the public, but they are considered non-confidential.  The
records are not commercially sensitive.

ii)  Sensitive Questions

This section does not apply because the regulation and the associated
information collection request do not seek information of a sensitive
nature.

4.   The Respondents and the Information Requested

a)   Respondents

Respondents for the recordkeeping requirement include users of
substitutes for ozone-depleting substances.  Principally, these
respondents are in the following major categories of industry groups, by
NAICS subsector or code:

NAICS code or subsector	Description of regulated entities

326150	Urethane and other foam product (except polystyrene)
manufacturing

334	Computer and Electronic Product Manufacturing

335	Equipment Appliance, and Component Manufacturing

336	Transportation Equipment Manufacturing

337	Furniture and Related Product Manufacturing

b)   Information Requested

i)   Data Items (for recordkeeping requirements):

EPA has based the estimated respondent burden and cost on typical
periods for completing tasks and costs for monitoring equipment for each
anticipated user of n-propyl bromide.  To the extent that companies
choose to comply by switching to another chemical or that chemical
suppliers already provide materials and analysis for exposure monitoring
to their customers, the estimates contained in this analysis may
overestimate the respondent burden and cost.

Records of worker exposure levels to n-propyl bromide, in parts per
million over an 8-hour time-weighted average.

Method used to measure worker exposure levels.

There is no specific format for these records.

ii)  Respondent Activities

There are limited activities required of respondents:

1)   Obtain exposure monitoring badges or other monitoring equipment.

2)   Perform initial exposure monitoring with the badges within 90 days
of finalization of the rule.

3)   Send the badges to a laboratory for analysis.

4)	   Ensure that workers use the badges at the prescribed frequency
(e.g., once every six or twelve months).

5)   Keep records of the exposure information.

Some suppliers of n-propyl bromide products already carry out activities
1 and 3 for their customers.

The proposal takes comment on keeping records for up to three years.
Under OSHA’s requirement for keeping exposure data at 29 CFR
1910.1020(d)(ii), an employer must keep any exposure data for at least
30 years.  EPA also takes comment on whether this requirement should be
incorporated in EPA’s rule, instead of the 3-year period.

 5.   The Information Collected - Agency Activities, Collection
Methodology and Information Management.

a)   Agency Activities

 EPA activities associated with this requirement are:

- to respond to questions from end users about the sufficiency of their
records

- to view records during inspections

b)   Collection Methodology and Management (including discussion of the
items mentioned in OMB(s remarks in the 1994 approval of the original
ICR)

EPA does not collect the information.  However, EPA staff could
potentially view records during inspections of facilities or request
copies from specific end users.

c)   Small Entity Flexibility

Small entities may contract with their suppliers for assistance in
exposure monitoring.  In addition, EPA is taking comment on ways to
reduce the total amount of monitoring required, as described above in
section 3.c.

d)   Collection Schedule

As with any records kept at a facility to demonstrate compliance, Agency
collection is on an (as needed( basis.  End users would need to update
their records every three months.

6.    Estimating the Burden and Cost of Collection

a)    Estimating Respondent Burden

b)    Estimating Respondent Costs

Table 6A/B presents estimates of annual respondent burden hours and
costs for each of the respondent activities described in section
4(b)(ii), with explanations of the assumptions made in each table.

Exhibit 6A/B: Annual Respondent Burden and Cost (1)

The following table shows estimates of respondent burden hours and
costs.  They are based on the following assumptions:

-Users will purchase exposure monitoring badges and have them analyzed
at $48 each and will require two badges for each worker using n-propyl
bromide during each monitoring event.

-We estimate as many as 4910 companies in the U.S. using n-propyl
bromide in the end uses addressed in the proposed regulation.  Up to
75,000 exposed workers would need to be monitored for exposure.  On
average, there are 15 workers to be monitored per respondent.

-Based on current exposure data, we expect that as many as 30,000
workers will need to be monitored every six months.  Although we expect
as many as 45,000 workers to be at facilities that qualify for relief
from periodic monitoring, at some portion of facilities, there may be an
event resulting in an increase in exposure levels that requires new
monitoring.  To account for this possibility in a manner that does not
underestimate costs, we assume that up to 45,000 workers need to be
monitored once per year.

-Users will need to scan exposure monitoring results to see if they are
below the workplace exposure limit.  We estimate this will require ten
minutes of technical or managerial time for each worker using nPB once
every monitoring event, with an average of 1.6 monitoring events per
year per worker.  This equates to an average of 16 minutes per worker
per year and an average of 4.1 hours per year per respondent.

-End users will need to file the records.  We estimate this will require
two minutes of clerical time for each facility for each monitoring event
and worker, with an average of 48 minutes per year per respondent.

- Labor costs representing an average hourly rate of pay, including
overhead and benefits, for a private company for labor that would be
classified as (technical( time at $60.00/hr and (clerical( time at
$20.00/hr.

- There is no start-up cost associated with this requirement.

-The annual operating and maintenance cost associated with this
recordkeeping requirement is based upon the above-mentioned labor costs
and the costs of monitoring badges and analysis.

	Table 6A/B: Annual Respondent Burden and Cost

Information Collection Activity

A

Resp.

Hours per

Year

B

Labor

Cost (A)@ $60/

hr, B)@ $20/hr)

per year

C

Annua-lized

Start-up

Cost 	D

Operating & Maintenance (O&M) Costs per respondent (avg of 49 badges
@$48 each per year)

E

No. of

Resp

F

Tot.

Hrs.

per

year

(A*E)

F

Total Annual-ized Cost per year

(C*E)

G

Total

Labor

Cost

per

year

(B*E)	H

Total O&M Costs per year

(D*E)

Recordkeeping requirement

A) Collect and review exposure data

      4.1

$  246.00

$       0	$ 2352.00

Maximum of 4910	 20,130

$         0

$ 1,202,700	$ 11,545,000

B) File records

      0.8

$    16.33

$       0	$0

Maximum of 4910	     3,930

$         0

$     80,000	$              0

                             Subtotals

      4.9

$ 262.33

$       0	$ 2352.00

Maximum of 4910	24,060

$         0

$ 1,282,700	$ 11,545,000

c)    Estimating Agency Burden and Costs

Exhibit 6C-1:  Annual Agency Burden and Costs

The following table shows estimates of EPA burden hours and costs for
the activities listed in section 5 above.  In making these estimates,
EPA made the following assumptions:

- The number of occurrences assumes that up to 1% of end users will have
sufficient questions about the recordkeeping requirement that they will
ask EPA for assistance.

- The number of hours per answer from EPA is 0.20, or 12 minutes.

- Labor cost is based on the annual 2005 salary for a GS 10/ Step 7
employee ($57,309), which is divided by 2,080 hours, the number of hours
in a federal work year  (resulting in an hourly rate of $27.55), then
multiplied by 1.6, the standard government benefits multiplication
factor (resulting in a final hourly rate of $44.08.)

-Agency activities such as inspections and enforcement are beyond the
scope of this ICR.

Exhibit 6C-1:  Annual Agency Burden and Costs

Agency activity

No. of occur-rences

No. of hours per occur-rence

Total no. of hours per year

Labor cost (@ $44.08/hr) per year

Cost of contract services per year

Total Cost per year

Answer questions re: recordkeeping requirement

    49

   0.2

   9.8

$   432

   n/a

$  432

              Totals

    49

   0.2

   9.8

$   432

   n/a

$   432

d)    Estimating the Respondent Universe and Total Burden and Costs

	See Table 6A/B in section 6(a) and (b) for these estimates.

e)    Bottom Line Burden Hours and Cost Tables

Exhibit 6E-1: Total Estimated Respondent Burden and Cost Summary

Information collection activity

No. of Resp-ondents per year

No. of Activities per year

Total Hours per year

Total Labor Cost per year

Total Annua-lized Start-up Costs

Total Annua-lized O&M Costs

Total Annua-

lized Costs

Total:  Recordkeeping for use condition

Maximum of 4,910

240,200

24,060

$ 1,283,000

$       0

$  11,545,000

$  12,828,000

These numbers are from the subtotals of Table 6 A/B.  Table 6E-1 counts
two activities for each collection of exposure data from each worker.

Exhibit 6E-2: Total Estimated Agency Burden and Cost Summary

Agency  activity

No. of Respondents

No. of Activities

Total Hours per year

Total Annual Labor Cost

Answer questions re: recordkeeping requirement

4910

49

9.8

$   432

                             Totals

4910

49

9.8

$   432

The total annual burden would remain the same from year to year.

f)    Reasons for Change in Burden

The total number of burden hours requested for this information
collection has increased from zero to 7400 hours because of the new
program requirement.

g)    Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 0.2 hours per response.  Burden
means the total time, effort, or financial resources expended by persons
to generate, maintain, retain, or disclose or provide information to or
for a Federal agency.  This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.  An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
The OMB control numbers for EPA's regulations are listed in 40 CFR part
9 and 48 CFR chapter 15.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID Number
[EPA-HQ or R###-XXX-XXXX-XXXX], which is available for online viewing at
  HYPERLINK "http://www.regulations.gov"  www.regulations.gov , or in
person viewing at the Air and Radiation Docket and Information Center in
the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution
Avenue, NW, Washington, D.C.  The EPA Docket Center Public Reading Room
is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays.  The telephone number for the Reading Room is (202)
566-1744, and the telephone number for the Air and Radiation Docket and
Information Center is<PHONE_NUMBER>.  An electronic version of the
public docket is available at www.regulations.gov.  This site can be
used to submit or view public comments, access the index listing of the
contents of the public docket, and to access those documents in the
public docket that are available electronically.  When in the system,
select “search,” then key in the Docket ID Number identified above.
Also, you can send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include
the EPA Docket ID Number EPA-HQ or R###-XXX-200X-XXXX and OMB Control
Number 2060-NEW in any correspondence.

Appendices

A-   Text of proposed SNAP regulation on n-propyl bromide

B-   Text of Section 612 of the Clean Air Act as amended in 1990

C-    Text of SNAP Regulations, 40 CFR Part 82, Subpart G

 PAGE  10


[Federal Register: August 13, 2008 (Volume 73, Number 157)]
[Notices]
[Page 47141-47142]
[DOCID:fr13au08-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1494-349]

Grand River Dam Authority; Notice of Application for Amendment of
License and Soliciting Comments, Motions To Intervene, and Protests

August 7, 2008.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Non-Project Use of Project Lands and Waters.
    b. Project No: 1494-349.
    c. Date Filed: July 18, 2008.
    d. Applicant: Grand River Dam Authority.
    e. Name of Project: Pensacola Project.
    f. Location: The project is located on the Grand (Neosho) River in
Craig, Delaware, Mayes, and Ottawa Counties, Oklahoma. The project does
not occupy federal or tribal lands. The proposed non-project use would
be located along the west shore of Isle's End Cove, an inlet to Monkey
Island, near Afton, Oklahoma.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Ms. Tamara Jahnke, Grand River Dam Authority,
P.O. Box 409, Vinita, OK 74301,<PHONE_NUMBER>.
    i. FERC Contact: Lorance Yates at<PHONE_NUMBER>, or by e-mail:
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: September 8, 2008.
    k. Description of Application: The licensee requests Commission
approval to grant St. Andrew's Harbor permission to modify its existing
docking facilities to include a new dock with eight boat slips and 21
personal water craft (PWC) slips, and one additional boat slip at an
existing dock. If approved, St. Andrew's Harbor would have a total of
seven

docks with 56 boat slips and 84 PWC slips.
    l. Location of Application: A copy of the application is available
for inspection and reproduction at the Commission's 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. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via e-mail of new filings and issuances related to this or
other pending projects. For assistance, call 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. 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.
    o. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'', as applicable, and the Project Number of the
particular application to which the filing refers. All documents
(original and eight copies) should be filed with: 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.
    p. 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.
    q. 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 at http://www.ferc.gov
under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-18732 Filed 8-12-08; 8:45 am]

BILLING CODE 6717-01-P


                             SUPPORTING STATEMENT
                     DRUG TESTING FOR CONTRACTOR EMPLOYEES

1. Identification of the Information Collection

      (a) Title of the Information Collection

"Drug Testing for Contractor Employees (Renewal)," EPA ICR Number 2183.08 and OMB Control Number 2030-0044.

      (b) Short Characterization

      This information collection request (ICR) applies to a contractor who performs response services at sensitive sites with serious security concerns where the Agency and public interest would best be protected through drug testing of contractor employees.  The Contracting Officer or On-Scene Coordinator will designate significant security concerns in the contractual tasking document when the situation warrants.  The contractor will test its employees for the use of marijuana, cocaine, opiates, amphetamines, phencyclidine (PCP), and any other controlled substances.  Only contractor employees who have been tested within the previous 90 calendar days and have passing drug test results may be directly engaged in on-site response work and/or on-site related activities at designated sites with significant security concerns. The testing for drugs must be completed prior to contract employee performance.  The contractor shall maintain records associated with all drug tests of their employees for three years in accordance with EPA Records Schedule 0569.

      (c) Terms of OMB Clearance

      OMB Terms of Clearance: "The Agency has clarified that it does not require drug testing of contractor employees, but rather that it requires the contractor to provide employees that have been drug tested. Should the agency begin to require drug testing, this ICR should be modified to reflect appropriate protections of respondent privacy."

      EPA contractors performing emergency response services at non-Federal facilities are not subject to the requirements and standards of Homeland Security Presidential Directive-12 (HSPD-12), e.g., leased office buildings, emergency response sites, private residences, schools, sites of law enforcement activity.  This type of location is not covered under HSPD-12.
There are no requirements for drug testing of contractor employees working at either Federal or non-Federal facilities under HSPD-12.

2. Need For and Use of The Collection

      (a) Need/authority for the Collection

      The legal authority for this collection is Title 5, Code of Federal Regulations, Parts 731, 732, and 736.  The EPA has a responsibility to protect the public and Agency and contractor employees working on an emergency response incident by ensuring employees are not under the influence of marijuana, cocaine, opiates, amphetamines, PCP, and any other controlled substances.  This process is necessary to allow the EPA to meet its responsibilities and mitigate the threat to the public health, welfare and the environment.

      (b) Uses/users of the Data

      Information is collected by contractors for performing drug tests on contract employees before the individual employees perform contractual services for the EPA.

3. Nonduplication, Consultation, and Other Collection Criteria

 Nonduplication

      Information requested from a contractor's employee to determine suitability to perform on a response contract is unique to a specific individual; this information cannot be obtained without a drug test.

      (b) Public Notice Required Prior to ICR submission to Office of Management and Budget.

  A notice to renew this information collection was posted to the Federal Register on March 8, 2021(86 FR 13369).  Public comments were due by May 7, 2021, and no relevant public comments were received.

      (c) Consultations

      To determine contractor burden associated with the information collection identified in this request, the following vendors were contacted but did not respond; therefore the estimated burden figures from the existing ICR are considered to still be applicable.  Estimated time to complete the information collection is described in Section 6, Estimating the Burden and Cost of the Collection.

_Representative__		               Firm___________	          ____Phone___
Joe Baer	  		Tech Law<PHONE_NUMBER>
Lisa Friday		            Weston Solutions<PHONE_NUMBER>
Eric Simpson	  		Sovereign Consulting<PHONE_NUMBER>

      (d) Effects of Less Frequent Collection

      The information provided by the contractors' employees is collected once prior to the employee performing under a response contract work on-site for the EPA and generally every quarter to ensure employees can meet the requirement of having been tested every 90 days prior to starting work on a sensitive site.  The requirement for drug testing cannot be met with a less frequent collection.

      (e) General Guidelines

      This ICR does not exceed any of the OMB guidelines found 5 CFR 1320.5(d)(2).

      (f) Confidentiality

      The EPA contractor is responsible for collecting and maintaining information under this collection of information; therefore, each contractor will have its own procedures for ensuring confidentiality.

      The EPA contractor is responsible for having the drug testing performed, and for providing, for work at sensitive sites, only those individuals who have passed the test within the previous 90 days.

      (g) Sensitive Questions

      No questions concerning sexual behavior or attitudes, religious beliefs, or other matters usually considered private are included in this information collection.

4. The Respondents and the Information Received

      (a) Respondents/North American Industry Classification System Codes

      Notification is provided from contractors of the passing status of proposed contractor and subcontractor employees who will perform services with regard to environmental emergencies involving the release, or threatened release, of oil, radioactive materials or hazardous chemicals that may potentially affect communities and the surrounding environment.  Information is collected for employees of the contractors and subcontractors who perform work in sensitive sites or sensitive projects corresponding with the North American Industry Classification System (NAICS) code 562910 for Remediation Services.

 Information Requested

      EPA is only requesting information on the status of proposed employees' drug test and the date of the drug testing. Submissions are accepted in any format, as long as they provide a passing status of proposed employees and the date the test was given. No other information is required to be submitted to the Agency.

5. The Information Collected: Agency Activities, Collection Methodology, and Information Management

      (a) Agency Activities

      The EPA contracting officers are responsible for ensuring that they have received notification from the contractor that all of its employees working under the contract at a response site with security concerns have passed the drug test for the use of marijuana, cocaine, opiates, amphetamines, PCP, and any other controlled substances.

      (b) Collection Methodology and Management

      The information is collected by contractors from their employees who work on sensitive response sites.  Compliance is mandatory and no employee may work on a response site with security concerns without passing the drug test.  Only those contractor employees who have been tested within the previous 90 calendar days may be directly engaged in on-site response work and/or on-site related activities at designated sites with significant security concerns.

      (c) Small Entity Flexibility

      Separate or further simplified requirements for small entities are not practical because the stated objectives cannot be met under such alternatives.  The requirements of the information collection apply to the awardees of the contract.  Reasonable expense associated with the drug testing is reimbursable; therefore, small businesses are not expected to experience financial difficulties in fulfilling these requirements.  There are numerous commercial sources that perform drug tests.

      (d) Collection Schedule

      Information on the passing status of proposed employees and the date the test was given will be collected as needed as individuals are requested to work on a response site location under new or existing contracts.

6. Estimating the Burden and Cost of the Collection

      (a) Estimation of Respondent Burden

      Respondent burden estimates for this collection are based upon discussions with the contractors identified in 3(b) above and discussions with Agency personnel.  The Agency anticipates that the contractor burden for complying with this requirement includes the time it takes for employees to provide the required information, the administrative time to manage a drug testing subcontract, the time to notify the Agency, and the effort to maintain the records.

      (b) Estimation of Respondent Costs

            (i) Estimating Labor Costs

                           Respondent Cost Estimate
Respondent Cost Estimate
                                                   Burden	         Loaded
Step	Collection Activity  	     	Labor Category        Hours              Rate__	    Cost
   1.  Time to provide sample		Employees	         1.5 hours         $74.00	$111.00
   2.  Cost of Drug Test					flat rate		$  50.00
      (subcontract)
   3.  Manage Drug Test		HR Manager	        0.25 hour	       $180.92	$  45.23
   subcontract & review results
   4.  Submit notification 		HR Manager	        0.25 hour        $180.92	$  45.23
   5.  Maintain files		       Admin. Support 	        0.25 hour          $58.25	$  14.56
            				        2.25 hours
            Estimated Respondent Cost per Drug Test                             $266.02

      Step 1 of the information collection is completed by a contractor employee working at a sensitive site. The 1.5-hour estimate is based upon information provided by the contractors who provided consultations in previous ICR renewals.  The contractors indicated that while it takes 15 minutes to provide a specimen, it does not take into account travelling to a lab, waiting to be called for the testing and returning to the job site.  The cost for Step 2, having a third party perform a drug test, is based upon market research and input from the vendors surveyed.  Vendors' costs for this ranged from $28-$85.  OHS Health and Safety Services, one of the largest drug testing companies in the United States, estimates average costs at $44 per test.  OHS' prices range from $25-$65 depending on the volume purchased.  This data can be found on the OHS website at www.ohsinc.com.  For estimating purposes for this ICR, $50 average was used. Steps 3 and 4, reviewing suitability and notifying EPA, are performed by a human resource-type manager responsible for personnel management and are estimated at 15 minutes based on vendor input. Administrative support personnel are responsible for completing step 5, which includes filing the background check in personnel records. This was estimated at 15 minutes based on vendor input.

      The cost associated with this effort was estimated using hourly rates based upon the May 2019 National Occupational Employment and Wage Estimates published by the U.S. Department of Labor's Bureau of Labor Statistics. The occupational categories used are Hazardous Materials Removal Workers, Human Resource Manager, and Office and Administrative Support.

      Since the labor rates used in this estimate are from 2019, an escalation factor of 3% was applied for each year to determine an average wage for the respective year.  The cost for each labor category was determined by multiplying the escalated hourly labor rate by an estimated loading factor of 2.95 to reflect industries' overhead, fringe benefits, and general and administrative costs for each year (2020-2023) that the ICR will be in effect.  The 2.95 estimate was provided by an EPA cost analyst as representative of labor related burdens experienced by EPA contractors.  The loaded labor costs for 2020 thru 2023 were added together then divided by three (number of years for the ICR) to arrive at an annualized labor cost for each labor category.

      The following are the loaded labor rates used in the calculations in the table above:

Employee  -  Hazardous Materials Removal Worker:
2019 = $22.95
2020 = ($22.95 x 1.03) = $23.64
2021 = ($23.64 x 1.03) = $24.35 x 2.95 = $ 71.83
2022 = ($24.35 x 1.03) = $25.08 x 2.95 = $ 73.98
2023 = ($25.08 x 1.03) = $25.83 x 2.95 = $ 76.20
                                      $222.01/3 = $74.00

Human Resource Manager:
2019 = $56.11
2020 = ($56.11 x 1.03) = $57.79
2021 = ($57.79 x 1.03) = $59.53 x 2.95 = $ 175.61
2022 = ($59.53 x 1.03) = $61.31 x 2.95 = $ 180.86
2023 = ($61.31 x 1.03) = $63.15 x 2.95 = $ 186.30
                                     $ 542.77/3 = $180.92

Administrative Support:
2019 = $18.07
2020 = ($18.07 x 1.03) = $18.61
2021 = ($18.61 x 1.03) = $19.17 x 2.95 = $ 56.55
2022 = ($19.17 x 1.03) = $19.74 x 2.95 = $ 58.23
2023 = ($19.74 x 1.03) = $20.33 x 2.95 = $ 59.97
                                     $174.75/3 = $58.25

 (ii)  Capital/ Start-up Costs

      Respondents will not be required to acquire capital goods to provide the requested information; therefore, capital start-up costs have not been included in this estimate.

      (iii)  Operating and Maintenance Costs

      Operating and maintenance costs, which include such items as file storage, photocopying, and postage, will be nominal.

      (c) Estimating Agency Burden and Cost

      Agency burden for responses to background check and suitability determinations.

                          Agency Burden Cost Estimate
                                 Labor			    Loaded
Step	Collection Activity		Category        Burden Hours	   _Rate_	Cost

   1.  Ensure Compliance and		GS-13		0.25 hour	   $113.54	$28.38
        document file
      				     Estimated Agency cost per drug test	$28.38

      Drug testing is the responsibility of the EPA contractor.  The Agency is primarily responsible for ensuring that contractors notify the Agency that its employees have passed the drug test.  The Agency's current effort is estimated to be performed by an employee at the GS-13 level and will take approximately fifteen minutes, which is about the same as previous years. The GS-13 hourly salary for 2020 with a locality pay for "Rest of US" is $49.54, and a 3 percent escalation factor has been applied for any cost-of-living increases given to federal workers in 2019 or 2020.  These wage rates were then multiplied by a factor of 2.16 to reflect Federal employee benefits. The 2.16 estimate was provided by an EPA cost analyst as representative of labor-related burdens for government employees. The loaded labor costs for 2018 thru 2020 were added together then divided by three (number of years for the ICR) for an annualized loaded rate of $105.44 for the three years the ICR is in effect.

2020 =			     $49.54
2021 = ($49.54 x 1.03) = $51.02 x 2.16 = $110.21
2022 = ($51.02 x 1.03) = $52.55 x 2.16 = $113.51
2023 = ($52.55 x 1.03) = $54.12 x 2.16 = $116.91
                                   $340.63/3 = $113.54

       (d) Estimating the Respondent Universe and Total Burden

      All EPA contractor personnel performing at an EPA designated sensitive site with significant security concerns must be tested for the presence of marijuana, cocaine, opiates, amphetamines, PCP, and any other controlled substances.  A site with significant security concerns is determined by the Agency and could be sites that involve law enforcement activities, any indoor cleanups (including household residences), drug lab cleanups, and response actions at geographically sensitive locations such as military installations and government buildings.  The number of contractor employees expected to submit to drug testing is around 1,500 for the life of this ICR (3 years).  This number was determined by estimating the number of drug tests that contractors provide in a year because they would be considered to have security concerns for the Agency.  Annually, the Agency responds to roughly 450 incidences with an estimated 5% of these responses (23) that may be designated as having security concerns for the Agency.

      There are both small and large businesses working in the field with diverse response site situations that require large variations in the number of employees.  Contractors may be on-site for a few days or many years depending on the situation.  Per the EPA Office of Acquisition Solution's active contract list, there are currently about 50 contracts which require contractors to perform drug testing on employees working at sensitive sites.  The number of annual drug tests performed by the companies ranged from 0 to 300, taking into account multiple tests for employees who are being tested quarterly.  The government estimate is 500 tests for all contractors per year.

      (e) Bottom Line Burden Hours and Costs

            (i) Respondent Tally

      Total estimated annual hours for this request is 1,125 hours at a cost of $133,010. The hours were calculated by multiplying the number of hours per occurrence, 2.25, by the estimated number of tests per year, 500.  The cost was derived by multiplying the respondent cost per collection, $266.02, by the estimated 500 occurrences per year. The total cost over the life of this ICR, three years, is $387,300.  The previous ICR estimated annual cost was $129,100.

            (ii) The Agency Tally

      The total annual Agency burden hours for this collection request are 125 hours.  This is calculated by taking the total number of contractor employees expected to submit to drug testing, 500 per year, by the estimated burden of 0.25 hour per occurrence. The total annual Agency burden cost is estimated at $14,190.  This is calculated by multiplying the estimated burden hours, 0.25, by the estimated hourly rate of $113.54 for a total of $28.38 for one collection request.  Then, the $28.38 is multiplied by the estimated number of annual occurrences, 500, for a total of $14,190 annually.  The estimated Agency cost over the life of this ICR, three years, is $42,570.

       (f) Reasons for Change in Burden

      No burden change.

      (g) Burden Statement

The annual public reporting and record keeping burden for this collection of information is estimated to average 2.25 hours per response.  Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency.  This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.   An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.  The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

 To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OARM-2018-0065 which is available for online viewing at www.regulations.gov, or in person viewing at the Office of Environmental Information in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C.  The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Office of Environmental Information is<PHONE_NUMBER>.  An electronic version of the public docket is available at www.regulations.gov.  This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically.  When in the system, select "search," then key in the Docket ID Number identified above.  Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include the EPA Docket ID Number EPA-HQ-OARM-2018-0065 and OMB Control Number 2030-0044 in any correspondence.


[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Notices]
[Page 34936]
[FR Doc No: 2015-15010]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2013-0026]

Executive Order 13650 Improving Chemical Facility Safety and
Security Webinar: Implementation Updates

AGENCY: Occupational Safety and Health Administration (OSHA), Labor

ACTION: Notice of listening session Webinar.

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

SUMMARY: The Department of Labor (DOL), in coordination with the
Department of Homeland Security (DHS) and the Environmental Protection
Agency (EPA), is announcing a Webinar to update stakeholders on action
items since the June 6, 2014 release of ``Executive Order [EO] 13650:
Actions to Improving Chemical Facility Safety and Security--A Shared
Commitment.''

DATES: The Webinar will take place on June 19th, from 1:00 to 2:30 p.m.
EDT.
    Registration to Participate: To register, please email your contact
information (first name, last name, company, title) to
<EMAIL_ADDRESS>As time permits, questions will be taken on a
first-come, first served basis--please let us know if you wish to
participate. You will be provided a separate email with webinar
connection and call-in instructions. There is no fee to register.

FOR FURTHER INFORMATION CONTACT: For general information on the EO,
visit the Web site at: https://www.osha.gov/chemicalexecutiveorder/.
For questions regarding the EO, please contact<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On August 1, 2013, President Obama issued EO 13650 to improve
chemical facility safety and security. The Working Group charged with
implementing the EO is co-chaired by DHS, DOL, and EPA, and includes
participation from the Departments of Justice, Agriculture, and
Transportation, all of whom play a role in chemical facility safety
measures. The Working Group gathered concerns, comments, feedback,
suggestions, and best practices from stakeholders over the course of
several Webinars and listening sessions which culminated in a Report to
the President released in May 2014, as well as an Action Plan contained
therein.
    The Working Group has made significant progress on the
implementation of the Action Plan since the release of the report by
initiating community planning preparedness measures, increasing Federal
coordination, improving data management techniques and technology,
revising regulations, issuing guidance and advisory documents, and
creating a best practices repository, among other initiatives.

II. Scope of Webinar

    The purpose of this Webinar is to update stakeholders and the
public on progress made on action items since the June 6, 2014 release
of ``Executive Order [EO] 13650: Actions to Improving Chemical Facility
Safety and Security--A Shared Commitment'', and to raise awareness of
the EO 13650 Working Group Web site, located at: www.osha.gov/chemicalexecutiveorder/.
    We encourage participation from the broad range of stakeholders who
have an interest in chemical facility safety and security to include,
but not limited to, chemical producers, chemical storage companies,
agricultural supply companies, State and local regulators, chemical
critical infrastructure owners and operators, first responders, labor
organizations representing affected workers, environmental and
community groups, and consensus standards organizations.

III. Public Participation

    This Webinar will accommodate over 600 participants. As time
permits, participants will be able to ask questions on a first-come
first-served basis. We will do our best to accommodate all persons who
wish to ask questions during the session. We request that participants
refrain from making statements, and use this time to ask questions.
Should time run out, participants may submit questions or statements
to<EMAIL_ADDRESS>
Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice.

    Signed at Washington, DC, on June 15, 2015.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2015-15010 Filed 6-17-15; 8:45 am]
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[Federal Register: August 6, 2009 (Volume 74, Number 150)]
[Notices]
[Page 39314]
[DOCID:fr06au09-53]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER09-1278-000]

AES Armenia Mountain Wind, LLC; Notice of Filing

July 30, 2009.
    Take notice that, on July 28, 2009, AES Armenia Mountain Wind, LLC
filed a supplement to its filing in the above captioned docket with
information required under the Commission's regulations. Such filing
served to reset the filing date in this proceeding.
    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, 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 on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    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>.
    Comment Date: 5 p.m. Eastern Time on August 18, 2009.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-18793 Filed 8-5-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 97 (Tuesday, May 20, 2014)]
[Notices]
[Pages 28927-28928]
[FR Doc No: 2014-11553]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Circulatory System Devices Panel of the Medical
Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues. Date and
Time: The meeting will be held on June 12, 2014, from 8 a.m. to 6 p.m.
Location: Holiday Inn Express/Highlands, 20260 Goldenrod Lane,
Germantown, MD 20876. The hotel telephone number is<PHONE_NUMBER>.
    Contact Person: Jamie Waterhouse, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993<EMAIL_ADDRESS>301-796-
3063, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-
443-0572 in the Washington, DC area). A notice in the Federal Register
about last minute modifications that impact a previously announced
advisory committee meeting cannot always be published quickly enough to
provide timely notice. Therefore, you should always check the Agency's
Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory committee meeting link, or call
the advisory committee information line to learn about possible
modifications before coming to the meeting.
    Agenda: On June 12, 2014, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application for the LUTONIX 035 Drug Coated Balloon PTA
Catheter sponsored by Lutonix, Inc. The LUTONIX 035 Drug Coated Balloon
PTA Catheter (LUTONIX DCB) is an over-the-wire percutaneous
transluminal angioplasty (PTA) catheter with a paclitaxel-based drug
coating on the surface of the balloon. The LUTONIX DCB is compatible
with a 0.035'' guidewire and has balloon sizes ranging from 4
millimeters (mm) to 6 mm in diameter and 40 mm to 100 mm in length. The
LUTONIX DCB catheter is available in 75 centimeters (cm), 100 cm and
130 cm working lengths.
    The proposed indications for use are for improving luminal diameter
for the treatment of obstructive de novo or non-stented restenotic
lesions (<=15cm in length) in native femoropopliteal arteries having
reference vessel diameters of 4 mm to 6 mm.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before June
4, 2014. On June 12, 2014, oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before May 28, 2014. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by May 30, 2014.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Conference Management Staff, at<EMAIL_ADDRESS>or 301-
796-5966 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: May 14, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-11553 Filed 5-19-14; 8:45 am]
BILLING CODE 4160-01-P