[Federal Register Volume 87, Number 224 (Tuesday, November 22, 2022)]
[Notices]
[Page 71321]
[FR Doc No: 2022-25399]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: CP20-70-000; CP20-68-000.
    Applicants: Enable Gas Transmission, LLC.
    Description: Enable Gas Transmission, LLC and Enable Gulf Run
Transmission, LLC submits Amended and Restated Capacity Lease Agreement
under CP20-68, et. al.
    Filed Date: 09/28/2022.
    Accession Number: 20220928-5148.
    Comment Date: 5 p.m. ET 11/22/22.

    Docket Numbers: RP23-191-000.
    Applicants: Enable Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Tariff Revisions to be
effective 12/15/2022.
    Filed Date: 11/15/22.
    Accession Number: 20221115-5136.
    Comment Date: 5 p.m. ET 11/28/22.

    Docket Numbers: RP23-192-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Article 11.2(a) Inflation
Adjustment Filing 2023 to be effective 1/1/2023.
    Filed Date: 11/15/22.
    Accession Number: 20221115-5169.
    Comment Date: 5 p.m. ET 11/28/22.

    Docket Numbers: RP23-193-000.
    Applicants: Mojave Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Annual Fuel and L&U Filing
2023 to be effective 1/1/2023.
    Filed Date: 11/16/22.
    Accession Number: 20221116-5057.
    Comment Date: 5 p.m. ET 11/28/22.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 16, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-25399 Filed 11-21-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 239 (Thursday, December 16, 2021)]
[Notices]
[Pages 71542-71543]
[FR Doc No: 2021-27219]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2018-0278]

Agency Information Collection Activities; Emergency Approval of a
Revision to a Currently-Approved Collection Request: Crime Prevention
for Truckers

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

ACTION: Notice of request for emergency OMB approval.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) of 1995,
this notice announces that a revision to the Information Collection
Request (ICR) discussed below has been forwarded to the Office of
Management and Budget (OMB) for review and emergency approval. FMCSA
will no longer be offering a $25 incentive for those who complete the
survey. FMCSA is also making non-substantive changes

to the survey to make it easier to complete and to make the data
collected more useful. The revised ICR describes the nature of the
information collection and its expected paperwork burdens. FMCSA
requests that OMB approve this collection by December 20, 2021.

DATES: Comments must be submitted on or before December 23, 2021.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within by December 23, 2021 to
www.reginfo.gov/public/do/PRAMain. All comments received are part of
the public record. Comments will generally be posted without change.
Upon receiving the requested emergency approval by OMB, FMCSA will
follow the normal PRA procedures to renew the information collection at
its expiration date.

FOR FURTHER INFORMATION CONTACT: Jeff Loftus, Division Chief,
Technology Division, Department of Transportation, FMCSA, West
Building, 6th Floor, 1200 New Jersey Avenue SE, Washington, DC 20590-
0001;<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:
    Title: Crime Prevention for Truckers.
    OMB Control Number: 2126-0071.
    Type of Request: Request for emergency approval for a revision to a
currently-approved information collection.
    Respondents: All truck drivers.
    Estimated Total Respondents: 1,320.
    Estimated Total Responses: 1,320.
    Estimated Burden Hours: 416.
    Estimated Burden per Response: 20 minutes per response.
    Frequency: Once.
    Background: OMB approved the ``Crime Prevention for Truckers''
collection on May 14, 2021. After receiving approval, FMCSA moved
forward in implementing the survey.
    Originally, the survey was planned to be an in-person data
collection, but the project team switched to an online data collection
because of the pandemic. Within hours of posting the survey online, it
reached its maximum number of responses. This occurred before FMCSA was
able to reach out to all desired women's trucking associations to
encourage participation by their members, thus undermining the purpose
of the survey. No rewards were paid by the agency.
    All proposed changes to the questions are de minimis or non-
substantive and are primarily driven by changes to some of the skip
patterns in the survey to make coding them on the online survey
platform (SurveyMonkey) possible. The changes do slightly increase the
time burden on the respondents, as they will need to respond to more
questions instead of having the survey skip ahead. However, this
increase is minimal.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for FMCSA to perform its functions; (2) the
accuracy of the estimated burden; (3) ways for FMCSA to enhance the
quality, usefulness, and clarity of the collected information; and (4)
ways that the burden could be minimized without reducing the quality of
the collected information.

    Issued under the authority delegated in 49 CFR 1.87.
Thomas P. Keane,
Associate Administrator, Office of Research and Registration.
[FR Doc. 2021-27219 Filed 12-15-21; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Notices]
[Pages 47882-47883]
[FR Doc No: 2012-19649]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2012-0013]

Lead in General Industry Standard; Extension of the Office of
Management and Budget's (OMB) Approval of Information Collection
(Paperwork) Requirements

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

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning its proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements specified in the Lead in General
Industry Standard (29 CFR 1910.1025).

DATES: Comments must be submitted (postmarked, sent, or received) by
October 9, 2012.

ADDRESSES: Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, OSHA Docket No. OSHA-2012-0013,
U.S. Department of Labor, Occupational Safety and Health
Administration, Room N-2625, 200 Constitution Avenue NW., Washington,
DC 20210. Deliveries (hand, express mail, messenger, and courier
service) are accepted during the Department of Labor's and Docket
Office's normal business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number (OSHA-2012-0013) for the Information Collection Request
(ICR). All comments, including any personal information you provide,
are placed in the public docket without change, and may be made
available online at http://www.regulations.gov. For further information
on submitting comments see the ``Public Participation'' heading in the
section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download from the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate
of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (PRA-95) (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
et seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and

accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain
such information with minimum burden upon employers, especially those
operating small businesses, and to reduce to the maximum extent
feasible unnecessary duplication of efforts in obtaining information
(29 U.S.C. 657).
    The information collection requirements in the Lead in General
Industry Standard are designed to reduce occupational lead exposure in
general industry. Lead exposure can result in both acute and chronic
effects and can be fatal in severe cases of lead toxicity. The standard
specifies the following requirements that impose paperwork burdens on
employers: Establishing a compliance program and notifying laundry
personnel of lead hazards; instituting programs for exposure monitoring
and medical surveillance (including medical examinations); notifying
workers of exposure levels and biological monitoring results; the
option for multiple physician review; providing information to
physicians; obtaining written medical opinions; implementing worker
information and training programs; recording medical removals;
maintaining and transferring records of exposure monitoring and medical
surveillance results, medical removals, and objective data used for the
initial exposure monitoring exemption; and making records available to
specified parties.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting an adjustment decrease in burden hours from
1,225,253 to 1,127,123 (a total decrease of 98,130 hours). The
adjustment is primarily due to a reduction in plants and a decrease in
covered workers, based on updated data.
    Type of Review: Extension of a currently approved collection.
    Title: Lead in General Industry (29 CFR 1910.1025).
    OMB Number: 1218-0092.
    Affected Public: Business or other for-profits; Federal Government;
State, Local or Tribal Government.
    Number of Respondents: 56,947.
    Frequency of Response: On occasion; quarterly, bi-monthly; semi-
annually; annually.
    Total Responses: 3,882,119.
    Average Time per Response: Varies from 5 minutes (.08 hour) to
maintain records to 1.5 hours to complete a medical examination.
    Estimated Total Burden Hours: 1,127,123.
    Estimated Cost (Operation and Maintenance): $143,191,684.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2012-0013). You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
dates of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.
Information on using the http://www.regulations.gov Web site to submit
comments and access the docket is available at the Web site's ``User
Tips'' link. Contact the OSHA Docket Office for information about
materials not available through the Web site and for assistance in
using the Internet to locate docket submissions.

V. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012
(77 FR 3912).

    Signed at Washington, DC, on August 7, 2012.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2012-19649 Filed 8-9-12; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Rules and Regulations]
[Page 16411]
[FR Doc No: 2013-06027]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2013-0131]

Drawbridge Operation Regulations; Saugatuck River, Westport, CT

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulation.

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SUMMARY: The United States Coast Guard has issued a temporary deviation
from the regulation governing the operation of the Route 136 Bridge
across the Saugatuck River, mile 1.3, at Westport, Connecticut. The
deviation is necessary to facilitate emergency repairs. Under this
temporary deviation, the bridge owner may require a 24 hour advance
notice for bridge openings.

DATES: This deviation is effective from March 5, 2013, through May 3,
2013.

ADDRESSES: The docket for this deviation, [USCG-2013-0131] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140, on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Ms. Judy Leung-Yee, Project Officer,
First Coast Guard District<EMAIL_ADDRESS>or (212) 668-
7165. If you have questions on viewing the docket, call Barbara
Hairston, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Route 136 Bridge has a vertical
clearance of 6 feet at mean high water in the closed position. The
existing drawbridge operating regulations are found at 33 CFR
117.221(c).
    The bridge owner, Connecticut Department of Transportation,
requested a 24 hour advance notice requirement for bridge openings to
facilitate emergency repairs to the mechanical and electrical
components at the bridge.
    The emergency repairs are necessary to repair storm damage from
Hurricane Sandy. The bridge has been operating manually since it
sustained damage from the storm.
    Under this temporary deviation, at least a 24 hour advance notice
shall be required for bridge openings at the Route 136 Bridge, mile
1.3, across the Saugatuck River at Westport, Connecticut, from March 5,
2013, through May 3, 2013.
    The Saugatuck River is predominantly a recreational waterway. The
bridge rarely opens during the time period this temporary deviation
will be in effect.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
repair period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: March 5, 2013.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2013-06027 Filed 3-14-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: September 24, 2008 (Volume 73, Number 186)]
[Rules and Regulations]
[Page 54981-54986]
[DOCID:fr24se08-15]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 594

[Docket No. NHTSA 2008-0114; Notice 2]
RIN 2127-AK33

Schedule of Fees Authorized by 49 U.S.C. 30141

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

ACTION: Final rule.

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SUMMARY: This document adopts fees for Fiscal Year 2009 and until
further notice, as authorized by 49 U.S.C. 30141, relating to the
registration of importers and the importation of motor vehicles not
certified as conforming to the Federal motor vehicle safety standards
(FMVSS). These fees are needed to maintain the registered importer (RI)
program.
    We are increasing the fees for the registration of a new RI from
$677 to $760 and the annual fee for renewing an existing registration
from $570 to $651. These fees include the costs of maintaining the RI
program. The fee required to reimburse Customs for conformance bond
processing costs will increase from $9.77 to $10.23 per bond. We are
decreasing the fees to be collected from the importer of each vehicle
covered by an import eligibility decision made on an individual make,
model, and model year basis. For vehicles determined eligible based on
their substantial similarity to a U.S. certified vehicle, the fee will
decrease from $208 to $198. For vehicles determined eligible based on
their capability of being modified to comply with all applicable FMVSS,
the fee will

also decrease from $208 to $198. In the event that a petitioner
requests an inspection of a vehicle, the fee for such an inspection
will remain $827 for vehicles that are the subject of either type of
petition. The fee that an RI must pay as a processing cost for review
of each conformity package that it submits to NHTSA will increase to
$14 from $13 per certificate. If the vehicle has been entered
electronically with Customs through the Automated Broker Interface
(ABI) and the registered importer has an e-mail address, the fee for
processing the conformity package will continue to be $6, provided the
fee is paid by credit card. However, if NHTSA finds that the
information in the entry or the conformity package is incorrect, the
processing fee will be $48, representing no change from the fee that is
currently charged when there are one or more errors in the ABI entry or
omissions in the statement of conformity.

DATES: The amendments established by this final rule will become
effective on October 1, 2008, the beginning of FY 2009. Petitions for
reconsideration must be received by NHTSA not later than November 10,
2008.

ADDRESSES: Petitions for reconsideration of this final rule should
refer to the docket and notice numbers identified above and be
submitted to: Administrator, National Highway Traffic Safety
Administration, 1200 New Jersey Avenue, SE., West Building, Washington,
DC 20590. It is requested, but not required, that 10 copies of the
petition be submitted. The petition must be received not later than 45
days after publication of this final rule in the Federal Register.
Petitions filed after that time will be considered petitions filed by
interested persons to initiate rulemaking pursuant to 49 U.S.C. Chapter
301.
    The petition must contain a brief statement of the complaint and an
explanation as to why compliance with the final rule is not
practicable, is unreasonable, or is not in the public interest. Unless
otherwise specified in the final rule, the statement and explanation
together may not exceed 15 pages in length, but necessary attachments
may be appended to the submission without regard to the 15-page limit.
If it is requested that additional facts be considered, the petitioner
must state the reason why they were not presented to the Administrator
within the prescribed time. The Administrator does not consider
repetitious petitions and unless the Administrator otherwise provides,
the filing of a petition does not stay the effectiveness of the final
rule.

FOR FURTHER INFORMATION CONTACT: Clint Lindsay, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>). For legal issues, you may call
Nicholas Englund, Office of Chief Counsel, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Introduction

    This rule was preceded by a notice of proposed rulemaking (NPRM)
that NHTSA published on August 4, 2008 (73 FR 45195).
    The National Traffic and Motor Vehicle Safety Act, as amended by
the Imported Vehicle Safety Compliance Act of 1988, and recodified at
49 U.S.C. 30141-30147 (``the Act''), provides for fees to cover the
costs of the importer registration program, the cost of making import
eligibility decisions, and the cost of processing the bonds furnished
to Customs. Certain fees became effective on January 31, 1990, and have
been in effect, with modifications, since then. On June 24, 1996, we
published a notice in the Federal Register at 61 FR 32411 that
discussed the rulemaking history of 49 CFR Part 594 and the fees
authorized by the Act. The reader is referred to that notice for
background information relating to this rulemaking action.
    We last amended the fee schedule in 2006. See final rule published
on August 3, 2006 at 71 FR 43985. Those fees applied to Fiscal Years
2007 and 2008.
    The fees adopted in this final rule are based on time expenditures
and costs associated with the tasks for which the fees are assessed.
They reflect the increase in hourly costs in the past two fiscal years
attributable to the approximately 2.64 and 4.49 percent raises
(including the locality adjustment for Washington, DC) in salaries of
employees on the General Schedule that became effective on January 1,
2007, and on January 1, 2008, respectively.

Comments

    There were no comments in response to the notice of proposed
rulemaking.

Requirements of the Fee Regulation

Section 594.6--Annual Fee for Administration of the Importer
Registration Program

    Section 30141(a)(3) of Title 49, U.S. Code provides that RIs must
pay the annual fee the Secretary of Transportation establishes ``* * *
to pay for the costs of carrying out the registration program for
importers * * *.'' This fee is payable both by new applicants and by
existing RIs. To maintain its registration, each RI, at the time it
submits its annual fee, must also file a statement affirming that the
information it furnished in its registration application (or in later
submissions amending that information) remains correct (49 CFR
592.5(f)).
    In compliance with the statutory directive, we reviewed the
existing fees and their bases in an attempt to establish fees that
would be sufficient to recover the costs of carrying out the
registration program for importers for at least the next two fiscal
years. The initial component of the Registration Program Fee is the fee
attributable to processing and acting upon registration applications.
We will increase this fee from $266 to $295 for new applications. We
have also determined that the fee for the review of the annual
statement submitted by existing RIs who wish to renew their
registrations will be increased from $159 to $186. These fee
adjustments reflect our time expenditures in reviewing both new
applications and annual statements with accompanying documentation, as
well as the inflation factor attributable to Federal salary increases
and locality adjustments in the two years since the regulation was last
amended.
    We must also recover costs attributable to maintenance of the
registration program that arise from the need for us to review a
registrant's annual statement and to verify the continuing validity of
information already submitted. These costs also include anticipated
costs attributable to the possible revocation or suspension of
registrations and reflect the amount of time that we have devoted to
those matters in the past two years.
    Based upon our review of these costs, the portion of the fee
attributable to the maintenance of the registration program is
approximately $465 for each RI, an increase of $54. When this $465 is
added to the $295 representing the registration application component,
the cost to an applicant comes to $760, which is the fee we are
adopting. This represents an increase of $83 over the existing fee.
When the $465 is added to the $186 representing the annual statement
component, the total cost to an RI renewing its registration comes to
$651, which represents an increase of $81.
    Section 594.6(h) enumerates indirect costs associated with
processing the annual renewal of RI registrations. The provision states
that these costs represent a pro rata allocation of the average salary
and benefits of employees who process the annual statements and perform
related functions, and ``a pro rata allocation of the costs
attributable

to maintaining the office space, and the computer or word processor.''
The indirect costs that were previously calculated at $17.07 per man-
hour are being increased by $3.24, to $20.31. This increase is based on
the difference between enacted budgetary costs within the Department of
Transportation for the last two fiscal years, which were higher than
the estimates used when the fee schedule was last amended, and takes
account of further projected increases over the next two fiscal years.

Sections 594.7 and 594.8--Fees To Cover Agency Costs in Making
Importation Eligibility Decisions

    Section 30141(a)(3) also requires RIs to pay other fees the
Secretary of Transportation establishes to cover the costs of ``* * *
(B) making the decisions under this subchapter.'' This includes
decisions on whether the vehicle sought to be imported is substantially
similar to a motor vehicle that was originally manufactured for
importation into and sale in the United States and certified by its
original manufacturer as complying with all applicable FMVSS, and
whether the vehicle is capable of being readily altered to meet those
standards. Alternatively, where there is no substantially similar U.S.-
certified motor vehicle, the decision is whether the safety features of
the vehicle comply with, or are capable of being altered to comply
with, the FMVSS based on destructive test information or such other
evidence that NHTSA deems to be adequate. These decisions are made in
response to petitions submitted by RIs or manufacturers, or on the
Administrator's own initiative.
    The fee for a vehicle imported under an eligibility decision made
in response to a petition is payable in part by the petitioner and in
part by other importers. The fee to be charged for each vehicle is the
estimated pro rata share of the costs in making all the eligibility
decisions in a fiscal year.
    The fee adopted by this final rule reflects the slight increase in
hourly costs in the past two fiscal years attributable to the
approximately 2.64 and 4.49 percent raises (including the locality
adjustment for Washington, DC) in salaries of employees on the General
Schedule that became effective on January 1, 2007, and on January 1,
2008, respectively.
    We have also reduced costs by issuing a single  Federal Register
notice to announce import eligibility decisions made on multiple
vehicles. Despite the cost savings that have accrued from this
development, RIs have imported fewer vehicles each year since we last
amended the fee schedule. This has increased the pro rata share of
petition costs that are to be assessed against the importer of each
vehicle covered by the decision to grant import eligibility. Although
the number of petitions submitted in the past two years has decreased,
the agency has devoted an increasing share of staff time to the review
and processing of import eligibility petitions owing to complications
that result when the petitioner or one or more commenters request
confidentiality for information they submit to the agency. Additional
staff time is also needed to analyze the petitions and any comments
received owing to new requirements being adopted in the FMVSS, such as
the advanced air bag rule that became effective September 1, 2006.
Despite these factors, we are not increasing the current fee of $175
that covers the initial processing of a ``substantially similar''
petition. We are also maintaining the existing fee of $800 to cover the
initial costs for processing petitions for vehicles that have no
substantially similar U.S.-certified counterpart.
    In the event that a petitioner requests an inspection of a vehicle,
the fee for such an inspection will remain $827 for vehicles that are
the subject of either type of petition.
    Importers of vehicles determined to be eligible for importation
pay, upon the importation of those vehicles, a pro rata share of the
total cost for making the eligibility decision. The importation fee
varies depending upon the basis on which the vehicle is determined to
be eligible. For vehicles covered by an eligibility decision on the
agency's own initiative (other than vehicles imported from Canada that
are covered by eligibility numbers VSA-80 through 83, for which no
eligibility decision fee is assessed), the fee will remain $125. NHTSA
determined that the costs associated with previous eligibility
decisions on the agency's own initiative will be fully recovered by
October 1, 2008. We will apply the fee of $125 per vehicle only to
vehicles covered by determinations made by the agency on its own
initiative on or after October 1, 2008.
    The agency's costs for making an import eligibility decision
pursuant to a petition are borne in part by the petitioner and in part
by the importers of vehicles imported under the petition. In 2007, the
most recent year for which complete data exist, the agency expended
$76,031 in making import eligibility decisions based on petitions. The
petitioners paid $6,975 of that amount in the processing fees that
accompanied the filing of their petitions, leaving the remaining
$69,056 to be recovered from the importers of the 236 vehicles imported
that year under petition-based import eligibility decisions. Dividing
$69,056 by 236 yields a pro rata fee of $293 for each vehicle imported
under an eligibility decision that resulted from the granting of a
petition.
    However, the agency believes that the volume of petition-based
imports for the next two fiscal years should not be projected on the
basis of a single year, particularly one in which the volume of
petitioned-based imports was atypically low. The agency therefore took
the average number of petition-based imports over the past 15 years to
project the number of such vehicles that would be imported in Fiscal
Years 2009 and 2010. Further, we assume that petitions filed during
Fiscal Years 2009 and 2010 would also more closely reflect the average
number of petitions received each year since 1991, the first year that
the agency received RI petitions. Based on these estimates, we project
that 621 vehicles would be imported under petition-based eligibility
decisions and that 39 petition-based import eligibility decisions would
be made.
    Based on these estimates, the agency's costs for processing these
petitions would increase to no more than $136,000. Petitioners would
pay slightly more than $13,000 of that amount in the processing fees
that accompany the filing of their petitions, leaving the remaining
$123,000 to be recovered from the importers of the 621 vehicles to be
imported each year under petition-based import eligibility decisions.
Dividing $123,000 by 621 yields a pro rata fee of $198 for each vehicle
imported under an eligibility decision that results from the granting
of a petition.
    Based on our estimates for Fiscal Years 2009 and 2010, the pro rata
fee to be paid by the importer of each such vehicle will decrease from
$208 to $198, representing a decrease of $10 from the existing fee for
each vehicle imported. The same $198 fee will be paid regardless of
whether the vehicle was petitioned under 49 CFR 593.6(a), based on the
substantial similarity of the vehicle to a U.S.-certified model, or was
petitioned under 49 CFR 593.6(b), based on the safety features of the
vehicle complying with, or being capable of being modified to comply
with all applicable FMVSS.

Section 594.9--Fee To Recover the Costs of Processing the Bond

    Section 30141(a)(3) also requires an RI to pay any other fees the
Secretary of Transportation establishes ``* * * to pay for the costs
of--(A) processing

bonds provided to the Secretary of the Treasury * * *''. Under Section
30141(d), the bond is provided at the time a nonconforming vehicle is
imported to ensure that the vehicle will be brought into compliance
within 120 days, as required by 49 CFR 591.8(d)(1), or if the vehicle
is not brought into compliance within such time, that it be exported,
without cost to the United States, or abandoned to the United States.
See Section 30141(d)(1)(B).
    Customs now exercises the functions associated with the processing
of these bonds. The statute contemplates that we will make a reasonable
determination of the cost that Customs incurs in processing the bonds.
In essence, the cost to Customs is based upon an estimate of the time
that a GS-9, Step 5 employee spends on each entry, which Customs has
judged to be 20 minutes.
    Based on General Schedule salary and locality raises that were
effective in January 2007 and 2008 and the inclusion of costs for
benefits, we are increasing the processing fee by $0.46, from $9.77 per
bond to $10.23. This fee will reflect the direct and indirect costs
that are actually associated with processing the bonds.

Section 594.10--Fee for Review and Processing of Conformity Certificate

    Each RI is currently required to pay $13 per vehicle to cover the
costs the agency incurs in reviewing a certificate of conformity. We
have found that these costs have increased to an average of $14 per
vehicle because of increased contractor and overhead costs. Based on
these costs, we are increasing the fee charged for vehicles for which a
paper entry and fee payment is made, from $13 to $14, a difference of
$1 per vehicle. However, if an RI enters a vehicle through the ABI
system, has an e-mail address to receive communications from NHTSA, and
pays the fee by credit card, the cost savings that we realize allow us
to significantly reduce the fee to $6. We are maintaining the fee of $6
per vehicle if all the information in the ABI entry is correct.
    Errors in ABI entries not only eliminate any time savings, but also
require additional staff time to be expended in reconciling the
erroneous ABI entry information with the conformity data that is
ultimately submitted. Our experience with these errors has shown that
staff members must examine records, make time-consuming long distance
telephone calls, and often consult supervisory personnel to resolve the
conflicts in the data. We have calculated this staff and supervisory
time, as well the telephone charges, to amount to approximately $42 for
each erroneous ABI entry. Adding this to the $6 fee for the review of
conformity packages on automated entries yields a total of $48,
representing no change in the fee that is currently charged when there
are one or more errors in the ABI entry or omissions in the statement
of conformity.

Statutory Basis for the Final Rule and Effective Date

    NHTSA is required under 49 U.S.C. 30141(e) to ``review and make
appropriate adjustments at least every 2 years in the amounts of the
fees'' relating to the registration of importers, the processing of
bonds, and making decisions concerning the importation of nonconforming
vehicles. The statute further requires the agency to ``establish the
fees for each fiscal year before the beginning of that year.'' This
final rule implements the statutory provisions. In the NPRM, we
proposed to make this rule effective October 1, 2008, and did not
receive any comments on this issue. In order to meet the statutory
deadline, the agency finds under 5 U.S.C. 553(d)(3) that it has good
cause to make this final rule effective less that thirty days after its
publication in the Federal Register. Accordingly, the effective date of
this final rule is October 1, 2008.

Rulemaking Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

    Executive Order 12866, ``Regulatory Planning and Review'' (58 FR
51735, October 4, 1993), provides for making determinations whether a
regulatory action is ``significant'' and therefore subject to Office of
Management and Budget (OMB) review and to the requirements of the
Executive Order. The Order defines a ``significant regulatory action''
as one that is likely to result in a rule that may:
    (1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or Tribal governments or
communities;
    (2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
    (4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    NHTSA has considered the impact of this rulemaking action under
Executive Order 12866 and the Department of Transportation's regulatory
policies and procedures. This rulemaking is not significant.
Accordingly, the Office of Management and Budget has not reviewed this
rulemaking document under Executive Order 12886. Based on the level of
the fees and the volume of affected vehicles, NHTSA currently
anticipates that the costs of the final rule would be so minimal as not
to warrant preparation of a full regulatory evaluation. The action does
not involve any substantial public interest or controversy. There would
be no substantial effect upon State and local governments. There would
be no substantial impact upon a major transportation safety program. A
regulatory evaluation analyzing the economic impact of the final rule
establishing the registered importer program, adopted on September 29,
1989, was prepared, and is available for review in the docket.

B. Regulatory Flexibility Act

    Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.,
as amended by the Small Business Regulatory Enforcement Fairness Act
(SBFEFA) of 1996), whenever an agency is required to publish a notice
of proposed rulemaking for any proposed or final rule, it must prepare
and make available for public comment a regulatory flexibility analysis
that describes the effect of the rule on small entities (i.e., small
businesses, small organizations, and small governmental jurisdictions).
The Small Business Administration's regulations at 13 CFR Part 121
define a small business, in part, as a business entity ``which operates
primarily within the United States.'' (13 CFR Sec.  121.105(a)). No
regulatory flexibility analysis is required if the head of an agency
certifies that the rule would not have a significant economic impact on
a substantial number of small entities. The SBREFA amended the
Regulatory Flexibility Act to require Federal agencies to provide a
statement of the factual basis for certifying that a rule would not
have a significant economic impact on a substantial number of small
entities.
    The agency has considered the effects of this rulemaking under the
Regulatory Flexibility Act, and certifies that the adopted amendments
will not have a significant economic impact upon a substantial number
of small entities.
    The following is NHTSA's statement providing the factual basis for
the certification (5 U.S.C. 605(b)). The adopted amendments will
primarily

affect entities that currently modify nonconforming vehicles and which
are small businesses within the meaning of the Regulatory Flexibility
Act; however, the agency has no reason to believe that these companies
would be unable to pay the fees adopted in this rulemaking action. In
most instances, these fees would not be changed or be only modestly
increased (and in some instances decreased) from the fees previously
being paid by these entities. Moreover, consistent with prevailing
industry practices, these fees should be passed through to the ultimate
purchasers of the vehicles that are altered and, in most instances,
sold by the affected registered importers. The cost to owners or
purchasers of nonconforming vehicles that are altered to conform to the
FMVSS may be expected to increase (or decrease) to the extent necessary
to reimburse the registered importer for the fees payable to the agency
for the cost of carrying out the registration program and making
eligibility decisions, and to compensate Customs for its bond
processing costs.
    Governmental jurisdictions will not be affected at all since they
are generally neither importers nor purchasers of nonconforming motor
vehicles.

C. Executive Order 13132 (Federalism)

    Executive Order 13132 on ``Federalism'' requires NHTSA to develop
an accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
Federalism implications.'' Executive Order 13132 defines the term
``policies that have federalism implications'' to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' Under Executive Order 13132, NHTSA may not issue a
regulation that has federalism implications, that imposes substantial
direct compliance costs, and that is not required by statute, unless
the Federal government provides the funds necessary to pay the direct
compliance costs incurred by State and local governments, or NHTSA
consults with State and local officials early in the process of
developing the proposed regulation.
    The amendments adopted in this final rule will not have substantial
direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government as specified in
Executive Order 13132. Moreover, NHTSA is required by statute to impose
fees for the administration of the RI program and to review and make
necessary adjustments in those fees at least every two years. Thus, the
requirements of section 6 of the Executive Order do not apply to this
rulemaking action.

D. National Environmental Policy Act

    NHTSA has analyzed this action for purposes of the National
Environmental Policy Act. The action would not have a significant
effect upon the environment because it is solely concerned with the
adjustment of fees associated with the agency's vehicle importation
program. On account of those fee adjustments, the annual volume of
motor vehicles imported through registered importers is not anticipated
to vary significantly from that existing before promulgation of the
rule.

E. Executive Order 12778 (Civil Justice Reform)

    Pursuant to Executive Order 12988 ``Civil Justice Reform,'' this
agency has considered whether the amendments adopted in this final rule
will have any retroactive effect. NHTSA concludes that those amendments
will not have any retroactive effect. Judicial review of the final rule
may be obtained pursuant to 5 U.S.C. 702. That section does not require
that a petition for reconsideration be filed prior to seeking judicial
review.

F. Unfunded Mandates Reform Act of 1995

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
requires agencies to prepare a written assessment of the costs,
benefits, and other effects of proposed or final rules that include a
Federal mandate likely to result in the expenditure by State, local, or
tribal governments, in the aggregate, or by the private sector, of more
than $100 million annually (adjusted for inflation with the base year
of 1995). Before promulgating a rule for which a written assessment is
needed, Section 205 of the UMRA generally requires NHTSA to identify
and consider a reasonable number of regulatory alternatives and to
adopt the least costly, most cost-effective, or least burdensome
alternative that achieves the objectives of the rule. The provisions of
Section 205 do not apply when they are inconsistent with applicable
law. Moreover, section 205 allows NHTSA to adopt an alternative other
than the least costly, most cost-effective or least burdensome
alternative if the agency publishes with the final rule an explanation
why that alternative was not adopted. Because this final rule will not
require the expenditure of resources beyond $100 million annually, this
action is not subject to the requirements of sections 202 and 205 of
the UMRA.

G. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995, a person is not required
to respond to a collection of information by a Federal agency unless
the collection displays a valid OMB control number. This final rule
will require no information collections.

H. Executive Order 13045

    Executive Order 13045 applies to any rule that (1) is determined to
be ``economically significant'' as defined under Executive Order 12866,
and (2) concerns an environmental, health, or safety risk that NHTSA
has reason to believe may have a disproportionate effect on children.
If the regulatory action meets both criteria, we must evaluate the
environmental health or safety effects of the planned rule on children,
and explain why the planned rule is preferable to other potentially
effective and reasonably feasible alternatives considered by us. This
rulemaking is not economically significant and does not concern an
environmental, health, or safety risk.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272)
directs NHTSA to use voluntary consensus standards in its regulatory
activities unless doing so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies, such as the Society of Automotive
Engineers (SAE). The NTTAA directs the agency to provide Congress,
through the OMB, explanations when we decide not to use available and
applicable voluntary consensus standards.
    After conducting a search of available sources, we have concluded
that there are no voluntary consensus standards applicable to this
final rule.

J. Privacy Act

    Anyone is able to search the electronic form of all submissions

received into any of our dockets by the name of the individual
submitting the comment or petition (or signing the comment or petition,
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 (Volume 65, Number 70; Pages
19477-78).

K. Regulation Identifier Number (RIN)

    The Department of Transportation assigns a regulation identifier
number (RIN) to each regulatory action listed in the Unified Agenda of
Federal Regulations. The Regulatory Information Service Center
publishes the Unified Agenda in April and October of each year. You may
use the RIN that appears in the heading on the first page of this
document to find this action in the Unified Agenda.

List of Subjects in 49 CFR Part 594

    Imports, Motor vehicle safety, Motor vehicles.

0
In consideration of the foregoing, Part 594, Schedule of Fees
Authorized by 49 U.S.C. 30141, in Title 49 of the Code of Federal
Regulations is amended as follows:

PART 594--SCHEDULE OF FEES AUTHORIZED BY 49 U.S.C. 30141

0
1. The authority citation for part 594 continues to read as follows:

    Authority: 49 U.S.C. 30141, 31 U.S.C. 9701; delegation of
authority at 49 CFR 1.50.

0
2. Amend Sec.  594.6 by:
0
A. Revising the introductory text of paragraph (a);
0
B. Revising paragraph (b);
0
C. Revising paragraph (d);
0
D. Revising the second sentence of paragraph (h); and
0
E. Revising paragraph (i) to read as follows:

Sec.  594.6  Annual fee for administration of the registration program.

    (a) Each person filing an application to be granted the status of a
Registered Importer pursuant to part 592 of this chapter on or after
October 1, 2008, must pay an annual fee of $760, as calculated below,
based upon the direct and indirect costs attributable to:
* * * * *
    (b) That portion of the initial annual fee attributable to the
processing of the application for applications filed on and after
October 1, 2008, is $295. The sum of $295, representing this portion,
shall not be refundable if the application is denied or withdrawn.
* * * * *
    (d) That portion of the initial annual fee attributable to the
remaining activities of administering the registration program on and
after October 1, 2008, is set forth in paragraph (i) of this section.
This portion shall be refundable if the application is denied, or
withdrawn before final action upon it.
* * * * *
    (h) * * * This cost is $23.31 per man-hour for the period beginning
October 1, 2008.
    (i) Based upon the elements and indirect costs of paragraphs (f),
(g), and (h) of this section, the component of the initial annual fee
attributable to administration of the registration program, covering
the period beginning October 1, 2008, is $465. When added to the costs
of registration of $295, as set forth in paragraph (b) of this section,
the costs per applicant to be recovered through the annual fee are
$760. The annual renewal registration fee for the period beginning
October 1, 2008, is $651.

0
3. Amend Sec.  594.7 by revising the section heading and paragraph (e)
to read as follows:

Sec.  594.7  Fee for filing petitions for a determination whether a
vehicle is eligible for importation.

* * * * *
    (e) For petitions filed on and after October 1, 2008, the fee
payable for seeking a determination under paragraph (a)(1) of this
section is $175. The fee payable for a petition seeking a determination
under paragraph (a)(2) of this section is $800. If the petitioner
requests an inspection of a vehicle, the sum of $827 shall be added to
such fee. No portion of this fee is refundable if the petition is
withdrawn or denied.
* * * * *

0
4. Amend Sec.  594.8 by revising paragraph (b) and the first sentence
of paragraph (c) to read as follows:

Sec.  594.8  Fee for importing a vehicle pursuant to a determination by
the Administrator.

* * * * *
    (b) If a determination has been made pursuant to a petition, the
fee for each vehicle is $198. The direct and indirect costs that
determine the fee are those set forth in Sec. Sec.  594.7(b), (c), and
(d).
    (c) If a determination has been made on or after October 1, 2008,
pursuant to the Administrator's initiative, the fee for each vehicle is
$125. * * *

0
5. Amend Sec.  594.9 by revising paragraph (c) to read as follows:

Sec.  594.9  Fee for reimbursement of bond processing costs.

* * * * *
    (c) The bond processing fee for each vehicle imported on and after
October 1, 2008, for which a certificate of conformity is furnished, is
$10.23.

0
6. Amend Sec.  594.10 by revising paragraph (d) to read as follows:

Sec.  594.10  Fee for review and processing of conformity certificate.

* * * * *
    (d) The review and processing fee for each certificate of
conformity submitted on and after October 1, 2008 is $14. However, if
the vehicle covered by the certificate has been entered electronically
with the U.S. Department of Homeland Security through the Automated
Broker Interface and the registered importer submitting the certificate
has an e-mail address, the fee for the certificate is $6, provided that
the fee is paid by a credit card issued to the registered importer. If
NHTSA finds that the information in the entry or the certificate is
incorrect, requiring further processing, the processing fee shall be
$48.

    Issued on: September 18, 2008.
Ronald L. Medford,
Senior Associate Administrator for Vehicle Safety.
[FR Doc. E8-22334 Filed 9-23-08; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 84, Number 84 (Wednesday, May 1, 2019)]
[Notices]
[Page 18630]
[FR Doc No: 2019-08849]

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

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of a Renewed Approval of Information Collection:
Certification Procedures for Products and Parts Correction

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice correction.

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

SUMMARY: The FAA published two notices in the Federal Register inviting
public comments about our intention to request the Office of Management
and Budget (OMB) approval to renew an information collection. The
Federal Register Notice with a 60-day comment period soliciting
comments on the following collection of information was published on
September 26, 2018. The Federal Register Notice with a 30-day comment
period soliciting comments on the following collection of information
was published on February 13, 2019. Both of these notices added an
additional five responses to the original collection request because of
adding additional blocks to one of the forms. This was incorrect. The
additional blocks were added, but the previous respondents had already
used the form using a previous block on the form. Also the new blocks
were named incorrectly.

FOR FURTHER INFORMATION CONTACT: Joy Wolf by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0018.
    Title: Certification Procedures for Products and Parts.
    Form Numbers: FAA Forms 8110-12, 8130-1, 8130-6, 8130-9, 8130-12.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on September 26, 2018 (83 FR 48682). The Federal Register
Notice with a 30-day comment period soliciting comments on the
following collection of information was published on February 13, 2019
(84 FR 3850). The request was to add five additional responses. This
was incorrect. The responses were already captured in Block 9A.
    The new block numbers added to the form were published in the 60-
day and 30-day notices inverted. Block 9D is Exhibition and block 9E is
Show Compliance with CFR.

    Issued in Washington, DC.
Joy Wolf,
Directives & Forms Management Officer (DMO/FMO), Aircraft Certification
Service.
[FR Doc. 2019-08849 Filed 4-30-19; 8:45 am]
 BILLING CODE 4910-13-P


Site Description Report

	Sibley Plant

	33200 E. Johnson Road

Sibley, MO

March 3, 2009

Background and Objectives

The Environmental Protection Agency (EPA) is in the process of
developing 316(b) cooling water intake structure requirements that
reflect the best technology available (BTA) for minimizing adverse
environmental impact for all existing power plants and manufacturing
facilities. As part of this process, EPA staff is visiting electric
generators and manufacturers to better understand the cooling water
intake structure (CWIS) technologies in use at facilities, including the
site-specific characteristics of each facility and how these affect the
selection and performance of CWIS technologies.  EPA is also visiting
facilities to better understand cooling water use and specific issues or
technologies that can affect 316(b) compliance.  As part of its site
visit to the Lake Road Plant, EPA also collected information on KCP&L
Greater Missouri Operations Company’s (KCP&L GMO) Sibley Plant.

Facility Description

The Sibley Plant is the largest generation facility owned and operated
by KCP&L GMO which operates under the KCP&L brand name.  See Section
10.0.  Sibley is located on the Missouri River in Jackson County
approximately 20 miles east of Kansas City.  It occupies approximately
100 acres next to the town of Sibley, Mo and employs approximately 135
people.

Cooling and process water withdrawals from and wastewater discharges to
the Missouri River are regulated under NPDES permit number MO0004871
which expired on November 2, 2005.  Sibley submitted its NPDES permit
application in a timely manner and is awaiting renewal of its permit by
the state.

Electricity Generation and Transmission

The Sibley Plant has three coal-fired boilers with a total generating
capacity of about 466 MW.  Units 1 and 2 each have a generating capacity
of 51 MW while Unit 3 has a generating capacity of approximately 364 MW.

The fuel source for the vast majority of power generation at Sibley is a
combination (75%/25%) of low/high BTU, low sulfur coal from the Powder
River Basin in Wyoming and Colorado.  In addition, according to a June
2004 press release, Sibley also receives waste tires that have been
shredded by independent companies to be used as a fuel source at this
plant.  Since 1997, Sibley has burned nearly 138 million pounds of scrap
tires.  According to the press release, a maximum of 5% of Sibley’s
power generation is from this alternative fuel source.

Cooling Water System and Intake Structure

Sibley has two CWISs that provide once-through cooling water for its
generating units: one for Units 1/2 and one for Unit 3.  The CWISs are
located in a deep channel on the outer bend of the Missouri River and
fitted with grizzlies (4 x 4s).  The combined CWIS for Units 1 and 2 has
three standard (i.e., coarse mesh 3/8”) traveling screens.  In
addition, four circulating water pumps provide a design intake flow per
screen of 22,500 gpm (total of 97.2 mgd) of cooling water to the
generating units.  The through-screen velocity is 1.4 feet per second
(fps).

The CWIS for Unit 3 has four ¼” dual flow screens.   Four circulating
water pumps provide a design intake flow of 45,000gpm of cooling water
per screen to the generating unit (total of 259.2 mgd).  The through
screen velocity is 1.4 fps.

Facility representatives noted they are not aware of any difference in
O&M associated with the two different screen types at this facility.

Sibley inspects its traveling screens annually.  It also cleans and
rebuilds one screen annually during its routine maintenance outage
period.  Approximately every 2 years (during a regularly scheduled
outage), Sibley will clean the silt out of the CWIS.

Impingement and Entrainment Information

KCP&L GMO representatives did not provide any information on
impingement, entrainment or source water body characterization for this
site.

Cooling Tower Feasibility

KCP&L GMO representatives indicated that Sibley has available land for
cooling tower placement, but that it is located about ½ mile from the
site.

Debris Handling

As with other facilities located on the Missouri River, debris can be
significant at Sibley.

Repowering/Future Uses

Sibley has no short term plans for re-powering or upgrading.

Cooling Ponds

Sibley does not have any cooling ponds.

Ownership

Sibley is owned by KCP&L GMO a subsidiary of Great Plains Energy.
Kansas City Power and Light Company is also a subsidiary of Great Plains
Energy.  Both subsidiaries operate under the KCP&L brand name.

316(a)

KCP&L GMO representatives did not provide any information related to
316(a) for this site.

Ash Handling

Bottom ash (slag) generated at Sibley is beneficially used.  Fly ash
that is not beneficially used is sluiced with river water to a 15 acre
ash pond.  Sibley cleans out its ash pond every few years and transfers
the waste material to an on-site landfill.

Air Emissions Controls

Sibley was recently equipped with a new SNCR and SCR.  Facility
representatives noted that the some of the new equipment is located in
the former employee parking lot.

 PAGE

 PAGE   1


[Federal Register Volume 77, Number 76 (Thursday, April 19, 2012)]
[Notices]
[Pages 23475-23476]
[FR Doc No: 2012-9382]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER12-1502-000]

Ironwood Windpower, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Ironwood Windpower, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR Part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability, is May 2, 2012.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC

Online service, please email<EMAIL_ADDRESS>or call (866)
208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 12, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-9382 Filed 4-18-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 37 (Monday, February 27, 2017)]
[Notices]
[Pages 11908-11909]
[FR Doc No: 2017-03764]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-989-000]

Chambersburg Energy, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Chambersburg Energy, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is March 13, 2017.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic 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
email notification when a document is added to a subscribed

docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: February 21, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-03764 Filed 2-24-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Pages 4508-4509]
[FR Doc No: 2019-02550]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket Number USCG-2018-0193]

Polar Security Cutter Program; Notice of Availability of Final
Programmatic Environmental Impact Statement

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability.

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SUMMARY: The U.S. Coast Guard, as lead agency, announces the
availability of the final Programmatic Environmental Impact Statement
(EIS) in accordance with the National Environmental Policy Act (NEPA)
for the Polar Security Cutter Program's design, build, and operation of
up to six polar security cutters (PSC).

DATES: The U.S. Coast Guard will not issue a final decision on the
proposal for a minimum of 30 days after the date on which the
Environmental Protection Agency (EPA) publishes its Notice of
Availability (NOA) of the final EIS in the Federal Register.

ADDRESSES: Copies of the final EIS have been sent to affected Federal,
State, and local governments; public libraries in the Project area; and
interested parties that previously requested a copy. The final EIS and
other supporting documents will be published in the docket at https://www.regulations.gov/docket?D=USCG-2018-0193 and also on the following
U.S. Coast Guard website: https://www.dcms.uscg.mil/Portals/10/CG-9/Acquisition%20PDFs/CG_PSC_Final%20PEIS_05%20Feb%202019.pdf?ver=2019-02-08-121637-803×tamp=1549650805158.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of availability, email Ms. Christine Wiegand, Assistant Program
Manager, Polar Security Cutter Program, U.S. Coast Guard; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Abbreviations

CFR Code of Federal Regulations
CGC Coast Guard Cutter
DHS Department of Homeland Security
EIS Environmental Impact Statement
FR Federal Register
NEPA National Environmental Policy Act
PIBs Polar Icebreakers
PSCs Polar Security Cutters
U.S.C. United States Code

Background and Purpose

    The Final EIS was prepared in accordance with the requirements of
NEPA; the CEQ regulations implementing NEPA (40 CFR 1500-1508); DHS
procedures for implementing NEPA (DHS Instruction Manual 023-01-001-01
(series)), U.S. Coast Guard procedures for implementing NEPA (COMDTINST
16475.1(series)); and other applicable DHS and U.S. Coast Guard
policies and guidance. A Notice of Intent (NOI) to prepare the EIS was
published in the Federal Register on April 26, 2018 (83 FR 18319) and
the Notice of Availability (NOA) of the Draft EIS was published in the
Federal Register on August 6, 2018 (83 FR 38317). The U.S. Coast Guard
is the lead agency for the proposed action.
    The purpose of the proposed action is to design, build, and operate
new PSCs to carry out the U.S. Coast Guard's primary missions supported
by the current polar icebreaker fleet. Expected missions include Ice
Operations, Defense Readiness, Aids to Navigation, Living Marine
Resources, Marine Safety, Marine Environmental Protection, Other Law
Enforcement, Ports, Waterways, and Coastal Security, and Search and
Rescue.
    The U.S. Coast Guard's current fleet of PIBs consists of two heavy
icebreakers, Coast Guard Cutter (CGC) POLAR STAR and CGC POLAR SEA, and
one medium icebreaker, CGC HEALY. The U.S. Coast Guard's heavy
icebreakers have both exceeded their designed 30 year service life. The
current PSC program acquisition strategy is approved to construct up to
three heavy PSCs and may (at a future date) potentially expand to
include up to three medium icebreakers, with planned service design
lives of 30 years each. The first of these new PSCs is expected to
delivered in 2023. Because the first new PSC would not be operational
in the Polar Regions until at least 2023, new information may become
available after the completion of this EIS. In that case, supplemental
NEPA documentation may, as appropriate, be prepared in support of
individual proposed actions. Examples of new information may include,
but are not limited to, changes to a species listing status or any
other applicable laws and directives, and information regarding
mission, training, homeporting, maintenance, and eventual
decommissioning of the new PSCs.
    In executing its various missions, the U.S. Coast Guard protects
the public, the environment, and U.S. economic and security interests
in any maritime

region, including international waters and the Nation's coasts, ports,
and inland waterways, as required to support national security.
Legislation and executive orders assign the U.S. Coast Guard a wide
range of responsibilities applicable to Polar Regions. The U.S. Coast
Guard derives its authority for the use of icebreaking from several
statutes governing execution of its missions. These include: 14 U.S.C.
541 (previously 14 U.S.C. 81) \1\ Coast Guard establishment,
maintenance, and operation of aids to navigation; 14 U.S.C. 521
(previously 14 U.S.C. 88) Coast Guard saving of life and property; 14
U.S.C. 522 (previously 14 U.S.C. 89) Coast Guard law enforcement; 14
U.S.C. 716 (previously 14 U.S.C. 90) Arctic maritime transportation; 14
U.S.C. 527 (previously 14 U.S.C. 91) controlling anchorage and movement
of vessels; 14 U.S.C. 715 (previously 14 U.S.C. 94) conduct
oceanographic research; and 14 U.S.C. 701 (previously 14 U.S.C. 141)
cooperation with agencies, States, territories, and others. In
addition, Executive Order 7521 (Use of Vessels for Icebreaking in
Channels and Harbors), 1 FR 2184, Dec. 24, 1936, directs the U.S. Coast
Guard to assist in keeping channels and harbors open to navigation by
means of icebreaking operations.
---------------------------------------------------------------------------

    \1\ The Frank LoBiondo Coast Guard Authorization Act of 2018
(Pub. L. 115-282), enacted December 4, 2018, redesignated many
existing sections within Title 14 of the United States Code.
---------------------------------------------------------------------------

    In accordance with NEPA, the U.S. Coast Guard prepared an EIS
analyzing the potential impacts of up to six new PSCs, as this is the
maximum number anticipated to be operational in the Polar Regions under
the current PSC program acquisition strategy. A lesser number of
icebreakers is expected to result in a similar or reduced impact than
what will be discussed and evaluated in the EIS. Potential
environmental stressors include acoustic (underwater acoustic
transmissions, vessel noise, icebreaking noise, aircraft noise, and
gunnery noise), and physical (vessel movement, aircraft or in-air
device movement, in-water device movement, icebreaking, and marine
expended materials).
    The Final EIS has considered three alternatives:
     The No Action Alternative included use of the existing
assets to fulfil Coast Guard missions, which are reaching the end of
their service lives.
     Alternative 1 (Preferred Alternative) included the design
and build up to six polar icebreakers to fulfill mission requirements
in the Arctic and Antarctic.
     Alternative 2 included various forms of icebreaker
leasing, such as those leases used by the United States Navy, the
National Science Foundation, other federal agencies, and the domestic
maritime industry, to close the Coast Guard icebreaking capability gap.
    The Final EIS addresses potential environmental impacts under each
alternative associated with physical, biological, and socioeconomic
environmental resources. The analysis addresses direct and indirect
impacts, and accounts for cumulative impacts from other foreseeable
federal, state, or local activities in the proposed action area. The
U.S. Coast Guard conducted a scoping process to identify community
concerns and local issues that should be addressed in the EIS, as well
as gathered public comments on the Draft EIS following its release in
August 2018. The Coast Guard considered the public comments we received
when drafting the Final EIS. The changes between the draft EIS and the
Final EIS are identified and described in Appendix C of the Final EIS,
which can be found at one of the locations in the ADDRESSES section.
    The Final EIS identifies minor to moderate adverse impacts
associated with the proposed action that would be mitigated by the
implementation of standard operating procedures and best management
practices. An increase in the Coast Guard icebreaking fleet would be
beneficial because Coast Guard support would readily available during
an at-sea emergiencies to commercial fishing, recreational fishing,
transportation and shipping, tourism, and cultural resources and the
communities that depend on them. The Final EIS has been distributed to
various federal, state, and local agencies, as well as other interested
individuals and organizations.
    Following a 30-day waiting period, after publication of the NOA in
the Federal Register, the U.S. Coast Guard will announce its Record of
Decision which will be published in the Federal Register.
    This notice is issued under authority of 5 U.S.C. 552(a).

Timothy J. Connors,
Captain, U.S. Coast Guard, Program Manager, Polar Security Cutter
Program.
[FR Doc. 2019-02550 Filed 2-14-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 57994-57996]
[FR Doc No: 2017-26441]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2483]

Software as a Medical Device: Clinical Evaluation; International
Medical Device Regulators Forum; Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Software as a Medical
Device (SaMD): Clinical Evaluation.'' This guidance was prepared as
part of the FDA's international convergence efforts under the auspices
of the International Medical Device Regulators Forum (IMDRF), formerly
the Global Harmonization Task Force. The guidance, informed by global
and U.S. public comments, pertains to Software as a Medical Device
(SaMD) and focuses on principles of clinical evaluation, which include
establishing the scientific validity, clinical performance, and
analytical validity for SaMD. The guidance is intended to provide
globally harmonized principles of when and what type of clinical
evaluation is appropriate based on the risk of the SaMD.

DATES: The announcement of the guidance is published in the Federal
Register on December 8, 2017.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-2483 for ``Software as a Medical Device (SaMD): Clinical
Evaluation.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Software as a Medical Device (SaMD): Clinical Evaluation'' to the
Office of the Center Director, Guidance and Policy Development, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Bakul Patel,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5458, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the IMDRF: Melissa A. Torres, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5432, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities across the globe to promote international
harmonization and convergence of regulatory requirements. One of the
goals of global convergence is to identify and reduce differences in
regulatory approaches among regulatory agencies. IMDRF seeks to advance
international convergence in the approach towards medical device
regulation with input from both regulatory and industry
representatives. The current members of the Management Committee of the
IMDRF are regulatory officials from Australia (Therapeutic Goods
Administration), Brazil (National Health Surveillance Agency), Canada
(Health Canada), China (China Food and Drug Administration), European
Union (European Commission Directorate-General for Internal Market,
Industry, Entrepreneurship, and Small and Medium-sized Enterprises),
Japan (Pharmaceuticals and Medical Devices Agency and the Ministry of
Health, Labour, and Welfare), Russia (Ministry of Healthcare),
Singapore (Health

Sciences Authority), and the United States (U.S. FDA). The World Health
Organization and the Asia-Pacific Economic Cooperation Life Sciences
Innovation Forum Regulatory Harmonization Steering Committee are IMDRF
Official Observers. The Asian Harmonization Working Party and the Pan
American Health Organization are IMDRF Affiliate Organizations.
    The IMDRF Management Committee (IMDRF MC) chartered the SaMD
Working Group (WG) to develop a regulatory framework for SaMD and to
develop converged principles for global regulators to adopt in their
respective jurisdictions. The SaMD WG includes representatives from the
IMDRF members, industry, academia, and other key stakeholders as well
as regional harmonization initiatives from around the world.
    The IMDRF SaMD WG considered comments received on the draft
guidance that was announced in the Federal Register of October 14, 2016
(81 FR 71105). The SaMD WG also considered public comments received by
other regulators and from other global stakeholders. The final IMDRF/
SaMD WG/N41 document, ``Software as a Medical Device (SaMD): Clinical
Evaluation,'' submitted to IMDRF MC was revised appropriately in
response to all of the comments. The IMDRF MC in Ottawa, Canada, at the
12th meeting held from September 19 to 21, 2017, unanimously approved
the document entitled ``Software as a Medical Device (SaMD): Clinical
Evaluation.'' This final IMDRF/SaMD WG/N41 document is available for
regulatory implementation according to the regulatory process in each
jurisdiction.
    This guidance adopts the internationally converged principles
agreed upon by the IMDRF. FDA adoption of these principles provides FDA
with an initial framework when further developing the Agency's specific
regulatory approaches and expectations for regulatory oversight. This
guidance does not provide recommendations for FDA Staff and Industry to
apply to specific regulatory situations, nor does it modify current
regulatory expectations, including those for regulatory submissions, at
this time. FDA intends to consider the principles of this guidance in
the development of regulatory approaches for SaMD and digital health
technologies. In developing regulatory approaches based on the
principles of this guidance, the Agency intends to follow a public
process, including providing opportunities for public input. For more
information on FDA adoption of IMDRF documents as an FDA guidance
document, please see https://www.fda.gov/MedicalDevices/InternationalPrograms/IMDRF/default.htm.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Software as a Medical Device (SaMD):
Clinical Evaluation.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations. This guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Software as a
Medical Device (SaMD): Clinical Evaluation'' may send an email request
to [email protected] to receive an electronic copy of the
document. Please use the document number 16039 to identify the guidance
you are requesting.

    Dated: December 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26441 Filed 12-7-17; 8:45 am]
 BILLING CODE 4164-01-P