[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10124-10125]
[FR Doc No: 2015-03769]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0303]

Robotically-Assisted Surgical Devices: Challenges and
Opportunities; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

    The Food and Drug Administration (FDA) is announcing the public
workshop entitled ``Robotically-Assisted Surgical (RAS) Devices:
Challenges and Opportunities.'' FDA is holding this public workshop to
obtain information on the current challenges and opportunities related
to robotically-assisted surgical medical devices, which are classified
as Class II medical devices. The purpose of this workshop is to obtain
public feedback on scientific, clinical, and regulatory considerations
associated with RAS devices. Comments and suggestions generated through
this workshop will facilitate further development of regulatory science
for RAS technologies.
    Dates and Times: The public workshop will be held on July 27 and
July 28, 2015, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at FDA's White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm. 1503A), Silver Spring, MD 20993. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: Mark Trumbore, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5402, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by July 17, 2015, at 4 p.m. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permits, onsite registration on the day
of the meeting/public workshop will be provided beginning at 7 a.m.
    If you need special accommodations due to a disability, please
contact Susan Monahan, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4321,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>no later than July 14, 2015.
    To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this meeting/public workshop from the posted events list.)
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone
number. Those without Internet access should contact Mark Trumbore to
register (see Contact Person). Registrants will receive confirmation
after they have been accepted. You will be notified if you are on a
waiting list.

    Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by Friday, July 17, 2015. Early registration is
recommended because Webcast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Webcast participants will be sent technical
system requirements after registration and will be sent connection
access information after July 20, 2015. If you have never attended a
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a
quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site addresses in
this document, but FDA is not responsible for any subsequent changes to
the Web sites after this document publishes in the Federal Register.)
    Comments: FDA is holding this public workshop to obtain information
on the specific topics outlined in section II. In order to permit the
widest possible opportunity to obtain public comment, FDA is soliciting
either electronic or written comment on all aspects of the public
workshop topics. The deadline for submitting comments related to this
public workshop is August 26, 2015.
    Regardless of attendance at the public workshop, interested persons
may submit either electronic comments to http://www.regulations.gov or
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. It is only necessary to send one set of comments. Please
identify comment with the docket number found in brackets in the
heading of this document. In addition, when responding to specific
topics as outlined in section II, please identify the topic(s) you are
addressing. 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.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

SUPPLEMENTARY INFORMATION:

I. Background

    RAS devices, also known as computer-assisted surgical devices, are
used by trained physicians in an operating room environment for
laparoscopic surgical procedures in general surgery, cardiac,
colorectal, gynecologic, head and neck, thoracic, and urologic surgical
procedures. These medical devices enable the surgeon to use computer,
software, and robotic technologies to control and move surgical
instruments through the mouth or through one or more small incisions in
the patient's body for a variety of surgical procedures. Some common
procedures that may involve RAS devices include gallbladder, uterus, or
prostate removal.
    As discussed further in section II, there are several clinical and
scientific challenges associated with regulation of RAS devices, such
as appropriate nonclinical and clinical evaluation of RAS devices, use
of third-party surgical instruments with legally marketed RAS devices,
and clinical training programs. This workshop seeks to involve industry
and academia in addressing these challenges in the development of RAS
devices to ensure that there is a reasonable assurance of safety and
effectiveness for RAS devices while promoting innovation in a rapidly-
developing field. By bringing together relevant stakeholders including
scientists, patient advocates, clinicians, researchers, industry
representatives, and regulators, we hope to facilitate the improvement
of this evolving product area.

II. Topics for Discussion at the Public Workshop

    Topics to be discussed at the public workshop include, but are not
limited to, the following:
    1. The current landscape of RAS devices and the respective Offices,
Divisions, and Branches within FDA involved in the review of pre- and
postmarket data associated with these devices.
    2. Challenges, needs, and benefit/risk profiles for indications in
various surgical areas; e.g. cardio/thoracic, gynecological,
otolaryngological, urological, general.
    3. Unique benefits of RAS devices versus traditional surgical
procedures.
    4. Scientific and technical considerations for third-party
manufacturers seeking to claim that their surgical instruments can be
used with legally marketed RAS devices.
    5. Design, administration, and certification of training programs
and FDA's role in this process.
    6. The future landscape of RAS and robotic surgery devices.
    7. Considerations regarding appropriate selection of preclinical
(bench and animal) test methods and patient-centered outcome metrics in
clinical use for different stages of device development.
    These topics will be presented by experts in the associated area,
followed by more in-depth discussions and Q&A from all participants.

    Dated: February 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03769 Filed 2-24-15; 8:45 am]
BILLING CODE 4164-01-P


U. S. ENVIRONMENTAL PROTECTION AGENCY 2000 MEAT PRODUCTS INDUSTRY SCREENER SURVEY TABLE OF CONTENTS Page INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i Completion of the Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii Provisions Regarding Data Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii Where to Return the Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii Certification Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii General Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi i EPA MEAT PRODUCTS SCREENER SURVEY HELP LINE Tetra Tech. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ( 800) ??????? Internet Electronic Mailing Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ???. com INTRODUCTION The U. S. Environmental Protection Agency ( EPA) is conducting a survey of the Meat Products Industry as part of its effort to review and revise, as appropriate, effluent limitations guidelines and standards for this industry. This Screener Survey requests data on sites engaged in meat product operations. The data collected with this Screener Survey will be used to better define basic characteristics of facilities in this industry. Knowing the basic characteristics of the industry will allow EPA to adequately estimate the possible economic impacts of wastewater regulations.

COMPLETION OF THE SCREENER SURVEY The Screener Survey should be completed by the person( s) most knowledgeable about the information requested. All sites must have the corporate official or designee responsible for directing or supervising of the survey response sign the Certification Statement ( located on page iv) to verify and validate the information provided, or to certify that this site does not engage in meat product processes.

You are not required to perform nonroutine tests or measurements solely for the purpose of responding to this Screener Survey. In the event that exact data are not available, provide best engineering estimates and note the methods that were used to make the estimates on the Comments page located at the end of the survey. General instructions are provided on page v, and additional instructions are provided as needed with each question. A complete set of definitions can be found in the Definitions Section, starting on page vi. ii AUTHORITY This Screener Survey is conducted under authority of Section 308 of the Clean Water Act ( Federal Water Pollution Control Act, 33 U. S. C. Section 1318). All sites that receive this Screener Survey must respond to it. Return all portions of the survey to the EPA within 20 days of receiving it. Late filing or failure to comply with these instructions may result in criminal fines, civil penalties, and other sanctions, as provided by law.

If you wish to request an extension for your site or discuss a delivery schedule for a company with multiple sites, you must do so in writing within 10 days of receipt of this Screener Survey. Send written requests to:

Ms. Samantha Lewis U. S. Environmental Protection Agency ( 4303) 1200 Pennsylvania Avenue NW Washington, DC 20460 Extension requests will be evaluated on a case by case basis. Submittal of an extension request to EPA does not alter the due date of your survey.

PROVISIONS REGARDING DATA CONFIDENTIALITY Regulations governing the confidentiality of business information are contained in the Code of Federal Regulations ( CFR) at Title 40 Part 2, Subpart B. You may assert a business confidentiality claim covering part or all of the information you submit, other than effluent data, as described in 40 CFR 2.203( b):

?( b) Method and time of asserting business confidentiality claim. A business which is submitting information to EPA may assert a business confidentiality claim covering the information by placing on ( or attaching to) the information, at the time it is submitted to EPA, a cover sheet, stamped or typed legend, or other suitable form of notice complying language such as <

trade secret,' <

proprietary,' or <

company confidential.' Allegedly confidential portions of otherwise nonconfidential documents should be clearly identified by the business, and may be submitted separately to facilitate identification and handling by EPA. If the business desires confidential treatment only until a certain date or until the occurrence of a certain event, the notice should so state."

If no business confidentiality claim accompanies the information when it is received by EPA, EPA may make the information available to the public without further notice.

You may claim as confidential all information included in the response to a question by checking the Confidential Business Information ( CBI) box next to each question number for which responses contain CBI. Any individual response where ?

CBI" is NOT checked will be considered nonconfidential. Note that you may be required to justify any claim of confidentiality at a later time. Note also that plant effluent data are not eligible for confidential treatment, pursuant to Section 308( b) of the Clean Water Act, and thus will be treated as nonconfidential even if the ?

CBI" box is checked.

Information covered by a claim of confidentiality will be disclosed by EPA only to the extent of, and by means of, the procedures set forth in 40 CFR Part 2, Subpart B. In general, submitted information protected by a business confidentiality claim may be disclosed to other employees, officers, or authorized representatives of the United States concerned with implementing the Clean Water Act.

Information covered by a claim of confidentiality will be made available to EPA contractors under EPA Contract Numbers 68 C6????, 68 C6????, and 68 C4???? to enable the contractors to perform the work required by their contracts with EPA. All EPA contracts provide that contractor employees use the information only for the purpose of performing the work required by their contracts and will not disclose any CBI to anyone other than EPA without prior written approval from each affected business or from EPA's legal office. Any comments you may wish to make on this issue must be submitted in writing along with your completed survey. iii WHERE TO RETURN THE SCREENER SURVEY After completing the Screener Survey and certifying the information that it contains, use the enclosed mailing label to mail the completed survey to:

U. S. Environmental Protection Agency Collection of 1999 Meat Products Industry Data c/ o Westat, Inc. ???

Retain a copy of the completed survey, including attachments. EPA will review the information submitted and may request your cooperation in answering follow up questions, if necessary, to complete our analyses.

CERTIFICATION STATEMENT Is your site engaged in full time, part time or intermittent meat product operations? ( For purposes of this survey, meat product operations include red meat and poultry slaughtering operations, by product operations, rendering, and further processing.)

G Yes ( Complete the survey; sign Certification Statement # 1 below when survey has been completed)

G No ( Sign Certification Statement # 2 below and return the following to EPA at the given address: Pages iii and iv and the cover page containing the site address label)

When the survey has been completed or ?

No" has been checked above, the individual responsible for directing or supervising the preparation of this survey must read and sign the appropriate Certification Statement listed below. The certifying official must be a responsible corporate official or his/ her authorized representative. iv Certification Statement # 1 I certify under penalty of law that the enclosed survey response was prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gathered and evaluated the information submitted. The information submitted is, to the best of my knowledge and belief, accurate and complete. In those cases where we did not possess the requested information, we provided best engineering estimates in response to the questions. We have to the best of our ability indicated what we believe to be company confidential business information as defined under 40 CFR Part 2, Subpart B. We understand that we may be required at a later time to justify our claim in detail with respect to each item claimed confidential. I am aware that there are significant penalties for submitting false information, including the possibility of fines and imprisonment as explained in Section 308 of the Clean Water Act.

Signature of Certifying Official Date ( ) Printed Name of Certifying Official Telephone Number Title of Certifying Official Certification Statement # 2 I certify under penalty of law that this site does not engage in meat product operations. I am aware that there are significant penalties for submitting false information, including the possibility of fines and imprisonment as explained in Section 308 of the Clean Water Act.

If you are certifying that your site is not engaged in meat product operations, indicate the classification of your site.

G Office G Distribution G Other ( specify):

Signature of Certifying Official Date ( ) Printed Name of Certifying Official Telephone Number Title of Certifying Official v GENERAL INSTRUCTIONS Complete this survey for your entire site. A site is one contiguous physical location at which meat product processes occur. In some instances, a site may include properties located within separate fence lines, but located close to each other.

Mark responses for each question. Fill in the appropriate response( s) to each question. Use black ink or type in the spaces provided. If the space allowed for the answer to any question is inadequate for your complete response, continue the response in the Comments area at the end of the survey, cross referencing the appropriate section and question number. If additional attachments are required to clarify a response, place the associated question number and your site ID number ( shown on the cover page) in the upper right corner of each page of the attachments.

Answer all questions unless instructed otherwise. The purpose of this survey is to gather all available information pertinent to meat product processes. Answer the questions in sequence unless you are directed to SKIP. Report only whole numbers, unless instructed otherwise. If a particular part of the required information is not applicable to your site, enter ?

NA" rather than leaving the answer blank. Enter zero where appropriate. Do not leave an entry blank if the answer is zero. You are required to provide best engineering estimates when data are not readily available. If you provide an estimate, note the methods that were used to make the estimates on the Comments page at the end of the survey. EPA does not intend for sites to conduct detailed studies to obtain the data. If you feel you need to conduct a detailed study, please call the Screener Survey Information Help Line at ( 800) ??????? or email your questions to ???. com.

Pay close attention to the measurement units requested. Be careful to provide data in the requested units.

Retain a copy of the completed survey for your records. EPA will review the information submitted and may request, if necessary, your cooperation in answering follow up clarification questions to complete the data collection effort. Retain a copy of the completed survey, including attachments, in case you ( i. e., the contact identified in Question 4) are contacted to clarify your responses. Also, please maintain a record of sources used to complete the questions.

Refer to the Definitions Section for terms which are used in this survey.

If you have any comments on a question or you feel an answer needs clarification, use the Comments page at the end of the survey. Be sure to cross reference your comments by question number.

Indicate information which should be treated as confidential by checking the Confidential Business Information ( CBI) box next to each question number with responses containing CBI. Any response where ?

CBI" is not checked will be considered nonconfidential. Refer to the instructions given in the PROVISIONS REGARDING DATA CONFIDENTIALITY section on page ii for additional information regarding EPA's confidentiality procedures set forth in 40 CFR Part 2, Subpart B. The CBI boxes begin with Question 8. vi DEFINITIONS Effluent Limitations Guidelines and Standards. Regulations promulgated by U. S. EPA under authority of Sections 301, 304, 306, and 307 of the Clean Water Act that set out minimum, national technology based standards of performance for point source wastewater discharges from specific industrial categories ( e. g., iron and steel manufacturing plants). Effluent limitations guidelines and standards regulations are implemented through the NPDES permit and national pretreatment programs and include the following:

Best Practicable Control Technology Currently Available ( BPT)

Best Available Technology Economically Achievable ( BAT)

Best Conventional Pollutant Control Technology ( BCT)

New Source Performance Standards ( NSPS)

Pretreatment Standards for Existing Sources ( PSES)

Pretreatment Standards for New Sources ( PSNS)

The pretreatment standards ( PSES, PSNS) are applicable to industrial facilities with process wastewater discharges to publicly owned treatment works ( POTWs). The effluent limitations guidelines and new source performance standards ( BPT, BAT, BCT, and NSPS) are applicable to industrial facilities with direct discharges of process wastewaters to waters of the United States.

Further Processing. Operations which utilize whole or cut up meat products for the production of cooked, canned, ground, chopped, diced, or breaded fresh or frozen products.

Meat Product Operations. Include red meat and poultry slaughtering operations, by product operations, rendering, and further processing.

NPDES Program. The National Pollutant Discharge Elimination System ( NPDES) program authorized by Sections 307, 318, 402, and 405 of the Clean Water Act which applies to facilities that discharge wastewater directly to United States surface waters.

Poultry. Broilers, other young chickens, hens, fowl, mature chickens, turkeys, capons, geese, ducks, and small game such as quail, pheasants, and rabbits.

Privately Owned Treatment Works ( PrOTWs). Any device or system owned and operated by a private entity and used for storage, treatment, recycling, or reclamation of liquid industrial wastes.

Process Wastewater. Any water which, during red meat or poultry operations, comes into direct contact with or results from the storage, production, or use of any raw material, intermediate product, finished product, by product, or waste product. Wastewater from equipment cleaning, direct contact air pollution control devices, rinse water, storm water associated with industrial activity, and contaminated cooling water are considered process wastewater. Process wastewater may also include wastewater that is contract hauled for off site disposal. Sanitary wastewater, uncontaminated noncontact cooling water, and storm water not associated with industrial activity are not considered process wastewater.

Publicly Owned Treatment Works ( POTWs). Any device or system owned and operated by a public entity and used in the storage, treatment, recycling, or reclamation of liquid municipal sewage and/ or liquid industrial wastes. The sewerage system that conveys wastewaters to treatment works is considered part of the POTW.

Red Meat. The term " red meat" includes all animal products from cattle, calves, hogs, sheep and lambs, etc., except those defined as Poultry.

Site. A site is generally one contiguous physical location at which manufacturing operations related to the meat products industry occur. This includes, but is not limited to, slaughtering, processing, and rendering. In some instances, a site may include properties located within separate fence lines, but located close to each other.

Surface Water. Waters of the United States as defined at 40 CFR 122.2. vii Wastewater. See Process Wastewater.

Zero Discharge or Alternative Disposal Methods. Disposal of process and/ or nonprocess wastewaters other than by direct discharge to a surface water or by indirect discharge to a POTW or PrOTW. Examples include land application, deep well injection, and contract hauling. 1 FACILITY INFORMATION 1. If the site mailing address shown on the front of the survey is correct, check (

) the box below. If it is not the correct address for this site, provide the correct site name and address in the spaces provided below.

G Address on cover page is correct ( Skip to Question 2)

Company Name Site Address or P. O. Box Subsidiary Name ( if any) Site Address continued Site or Plant Name City State ZIP Code 2. If the street ( i. e., physical) address of your site is different from the mailing address on the cover page or given in Question 1, provide the street address in the spaces provided below. If the mailing address and street address are the same, check (

) the box below.

G Address on cover page or response to Question 1 is physical address.

Street Address City Street Address continued State ZIP Code 3. What is the name and address of the company that owns this site?

Name of Company Mailing Address or P. O. Box City State ZIP 4. Provide the name, title, telephone number, and facsimile number of the contact at your site for information supplied in this survey.

Contact Name Contact Title ( ) Telephone Number ( ) Facsimile Number 2 G CBI 5. In 1999, were any meat product operations ( as defined above) performed at your site?

G Yes ( Identify all types of animals processed for each operation performed in table below)

Operation Red Meat Type Poultry Type Cattle Pigs Other Red Meat ( Specify_______) Chickens Turkeys Other Poultry ( Specify_______)

Slaughtering G G G G G G Further Processing G G G G G G Rendering G G G G G G G No ( Skip to Question 7)

G CBI 6. Were any type( s) of process wastewaters ( see definition of process wastewater above) generated at your facility for Meat Product Operations in 1999?

G Yes ( complete table below for all that apply)

Wastewater Disposal Method Amount of Process Wastewater Disposed in 1999 in for Meat Product Operations ( Gallons/ Year)

G Discharged to a surface water under an NPDES permit G Discharged to publicly owned treatment works ( POTW)

G Land applied on site G Surface impoundment on site ( as final disposal)

G Transferred to an off site commercial waste treatment facility G Transferred to an off site intracompany wastewater treatment facility G Other ( Please specify ____________________)

G No ( Skip to Question 7)

G CBI 7. For fiscal year 1999, list the average number of full time equivalent ( FTE) employees at the site and company ( i. e., 2080 hr/ yr). For example, four half time employees would be listed as two full time equivalent employees.

a. ______________________________ Number of FTE employees at the site b. ______________________________ Number of FTE employees at the company COMMENTS 3 Cross reference your comments by question number and indicate the confidential status of your comment by checking (

) the box in the column titled ?

CBI" ( Confidential Business Information).

Question Number CBI Comment G G G G G


[Federal Register Volume 78, Number 109 (Thursday, June 6, 2013)]
[Notices]
[Page 34093]
[FR Doc No: 2013-13397]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP13-481-000]

WBI Energy Transmission; Notice of Request Under Blanket
Authorization

    Take notice that on May 16, 2013, WBI Energy Transmission (WBI),
1250 West Century Avenue, Bismarck, North Dakota 58503, filed a prior
notice application pursuant to sections 157.216(b) of the Federal
Energy Regulatory Commission's regulations under the Natural Gas Act
(NGA), and WBI's blanket certificate issued in Docket No. CP82-487-000,
to abandon natural gas storage facilities located at the Baker Storage
Reservoir in Fallon County, Montana. Specifically, WBI proposes to plug
and abandon two natural gas storage wells and to abandon in place two
associated well lines and remove one associated well line, all as more
fully set forth in the application, which is open to the public for
inspection. The filing may also be viewed on the web at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions regarding this application should be directed to
Keith A. Tiggelaar, Director of Regulatory Affairs, WBI Energy
Transmission, Inc., 1250 West Century Avenue, Bismarck, North Dakota
58503, or telephone<PHONE_NUMBER> or by email
<EMAIL_ADDRESS>    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the NGA (18 CFR 157.205) file a protest to the request. If no protest
is filed within the time allowed therefore, the proposed activity shall
be deemed to be authorized effective the day after the time allowed for
protest. If a protest is filed and not withdrawn within 30 days after
the time allowed for filing a protest, the instant request shall be
treated as an application for authorization pursuant to section 7 of
the NGA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link. Persons unable to file
electronically should submit an original and 5 copies of the protest or
intervention to the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426.

    Dated: May 30, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-13397 Filed 6-5-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61719-61721]
[FR Doc No: 2018-26061]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2018-0007; Notice 1]

Notice of Receipt of Petition for Decision That Nonconforming
Model Year 2016 Mercedes-Benz GL500 Multipurpose Passenger Vehicles Are
Eligible for Importation

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

ACTION: Receipt of petition.

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

SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
certain model year (MY) 2016 Mercedes-Benz GL500 multipurpose passenger
vehicles (MPVs) that were not originally manufactured to comply with
all applicable Federal motor vehicle safety standards (FMVSS), are
eligible for importation into the United States because they are
substantially similar to

vehicles that were originally manufactured for sale in the United
States and were certified by their manufacturer as complying with the
safety standards (the U.S.-certified 2016 Mercedes-Benz GL550 MPV) and
are capable of being readily altered to conform to the standards.

DATES: The closing date for comments on the petition is December 31,
2018.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket number cited in the title of this notice and must be submitted
by any of the following methods:
     Mail: Send comments by mail addressed to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590.
     Hand Delivery: Deliver comments by hand to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590. The Docket Section is open on weekdays from 10 a.m. to 5 p.m.
except for Federal Holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) website at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the internet at
https://www.regulations.gov by following the online instructions for
accessing the dockets. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000, (65 FR 19477-78).

FOR FURTHER INFORMATION CONTACT: Neil Thurgood, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:
    I. History: Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that
was not originally manufactured to conform to all applicable FMVSS
shall be refused admission into the United States unless NHTSA has
decided that the motor vehicle is substantially similar to a motor
vehicle originally manufactured for importation into and sale in the
United States, certified under 49 U.S.C. 30115, and of the same model
year as the model of the motor vehicle to be compared, and is capable
of being readily altered to conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    II. Summary of Petition: Wallace Environmental Testing Laboratories
(WETL), of Houston, Texas (Registered Importer R-90-005) has petitioned
NHTSA to decide whether nonconforming MY 2016 Mercedes-Benz GL500 MPVs
are eligible for importation into the United States. The vehicles which
WETL believes are substantially similar are MY 2016 Mercedes-Benz GL550
MPV sold in the United States and certified by their manufacturer as
conforming to all applicable FMVSS.
    The petitioner claims that it compared non-U.S.-certified MY 2016
Mercedes-Benz GL500 MPVs to their U.S.-certified counterparts, and
found the vehicles to be substantially similar with respect to
compliance with most FMVSS.
    The petitioner submitted information with its petition intended to
demonstrate that the subject non-U.S.-certified vehicles, as originally
manufactured, conform to many applicable FMVSS in the same manner as
their U.S.-certified counterparts, or are capable of being readily
altered to conform to those standards.
    Specifically, the petitioner claims that the non-U.S.-certified MY
2016 Mercedes-Benz GL500 MPVs, as originally manufactured, conforms to:
Standard Nos. 102 Transmission Shift Position Sequence, Starter
Interlock, and Transmission Braking Effect, 103 Windshield Defrosting
and Defogging Systems, 104 Windshield Wiping and Washing Systems, 106
Brake Hoses, 110 Tire Selection and Rims and Motor Home/Recreation
Vehicle Trailer Load Carrying Capacity Information for Motor Vehicles
with a GVWR of 4,536 kilograms (10,000 pounds) or Less, 113 Hood Latch
System, 116 Motor Vehicle Brake Fluids, 118 Power-Operated Window,
Partition, and Roof Panel Systems, 124 Accelerator Control Systems, 126
Electronic Stability Control Systems for Light Vehicles, 135 Light
Vehicle Brake Systems, 138 Tire Pressure Monitoring Systems, 201
Occupant Protection in Interior Impact, 202a Head Restraints; Mandatory
Applicability Begins on September 1, 2009, 203 Impact Protection for
the Driver from the Steering Control System, 204 Steering Control
Rearward Displacement, 205 Glazing Materials, 206 Door Locks and Door
Retention Components, 207 Seating Systems, 209 Seat Belt Assemblies,
210 Seat Belt Assembly Anchorages, 212 Windshield Mounting, 214 Side
Impact Protection, 216 Roof Crush Resistance, Applicable unless a
Vehicle is Certified to Sec.  571.216a, 219 Windshield Zone Intrusion,
225 Child Restraint Anchorage Systems, 301 Fuel System Integrity, and
302 Flammability of Interior Materials.
    The petitioner also contends that the subject non-U.S.-certified
MPVs are capable of being readily altered to meet the following
standards, in the manner indicated:
    Standard No. 101 Controls and Displays: The brake warning telltale
must be modified to show the word ``BRAKE'' when activated.
    Standard No. 108 Lamps, Reflective Devices and Associated
Equipment: The headlamps and front side marker lamps must be removed
and replaced with conforming lamps.
    Standard No. 111 Rearview Mirrors: The passenger side mirror must
be replaced with a U.S.-model that includes the required warning label.
    Standard No. 114 Theft Protection and Rollaway Prevention:
Installation of the U.S.-model anti-theft system to activate the key
warning, audible alarm.
    Standard No. 208 Occupant Crash Protection: Inspection to ascertain
if the software and firmware installed in the vehicle are the same as
the most up-to-date versions installed in the U.S.-conforming version
of the vehicle. Replacement of any software or

firmware found not to be the most recent version.
    The petitioner further states that labels will be affixed to
conform the vehicle to the requirements of 49 CFR parts 565 and 567,
VIN Content and Certification, respectively.
    III. Comments: All comments and supporting materials received
before the close of business on the closing date indicated above will
be filed in the docket and considered. Comments filed after the closing
date will also be considered to the fullest extent possible and
available for examination in the docket at the above ADDRESSES.
    Once the petition is granted or denied, notice of the decision will
be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    This notice of receipt of the subject petition does not represent
any agency decision or other exercise of judgment concerning the merits
of the petition. Notice of final action on the petition will be
published in the Federal Register pursuant to the authority indicated
below.

    Authority: 49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49
CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.

Michael A. Cole,
Acting Director, Office of Vehicle Safety Compliance.
[FR Doc. 2018-26061 Filed 11-29-18; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 9001-9003]
[FR Doc No: 2018-04256]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1112]

United States Food and Drug Administration and Health Canada
Joint Regional Consultation on the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a regional public meeting entitled ``U.S. Food and Drug Administration
and Health Canada Joint Regional Consultation on the International
Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH).'' The purpose of the public meeting is to provide
information and solicit public input on the current activities of the
ICH, as well as the upcoming ICH Assembly Meeting and the Expert
Working Group Meetings in Kobe, Japan, scheduled for June 4 through 7,
2018. The topics to be addressed at the public meeting are the current
ICH guideline topics under development that will be discussed at the
forthcoming ICH Assembly Meeting in Kobe.

DATES: The public meeting will be held on Friday, April 6, 2018, from
10 a.m. to 1 p.m. Submit either electronic or written comments on this
public meeting by April 30, 2018. See the SUPPLEMENTARY INFORMATION
section for registration date and information.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (Great
Room), Silver Spring, MD 20993-0002. The meeting will also be broadcast
on the web, allowing participants to join in person OR via the web. For
those who will attend in person, the entrance for the public meeting
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. For
those who register to attend the public meeting remotely via the
webcast, a link to access the webcast will be emailed 1 week in advance
of the meeting.
    You may submit comments as follows. Please note that late,
untimely, filed comments will not be considered. Electronic comments
must be submitted on or before April 30, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 30, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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 in the sections below (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-N-1112 for ``U.S. Food and Drug Administration and Health
Canada Joint Regional Consultation on the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use; Public Meeting; Request for Comments.'' Received comments, those
filed in a timely manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Amanda Roache, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002, 301-
796-4548, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The ICH, formerly known as the International Conference on
Harmonisation, was established in 1990 as a joint regulatory/industry
project to improve, through harmonization, the efficiency of the
process for developing and registering new medicinal products in
Europe, Japan, and the United States without compromising the
regulatory requirements for safety and effectiveness. One of the goals
of harmonization is to identify and then reduce regional differences in
technical regulatory requirements for pharmaceutical products while
preserving a consistently high standard for drug efficacy, safety, and
quality. In 2015, the ICH was reformed to establish ICH as a true
global initiative that expands beyond the previous ICH members. More
involvement from regulators around the world is expected, as they join
counterparts from Europe, Japan, the United States, Canada, and
Switzerland as ICH observers and regulatory members. Expanded
involvement is also anticipated from global regulated pharmaceutical
industry parties, joining as ICH observers and industry members. The
reforms build on a 25-year track record of successful delivery of
harmonized guidelines for global pharmaceutical development and their
regulation.
    ICH guidelines are developed following a five-step process. In Step
1, experts from the different ICH regions work together to prepare a
consensus draft of the Step 1 Technical Document. The Step 1 Technical
Document is submitted to the ICH Assembly to request endorsement under
Step 2a of the process. Step 2b is a ``Regulators only'' step in which
the ICH regulatory members review the Step 2a Final Technical Document
and take any actions, which might include revisions that they deem
necessary, to develop the draft ``Guideline.'' Step 3 of the process
begins with the public consultation process conducted by each of the
ICH regulatory members in their respective regions, and this step
concludes with completion and acceptance of any revisions that need to
be made to the Step 2b draft guideline in response to public comments.
Adoption of the new guideline occurs in Step 4. Following adoption, the
harmonized guideline moves to Step 5, the final step of the process
when it is implemented by each of the regulatory members in their
respective regions. The ICH process has achieved significant
harmonization of the technical requirements for the approval of
pharmaceuticals for human use in the ICH regions since 1990. More
information on the current ICH process and structure can be found at
the following website: http://www.ich.org/home.html. (FDA has verified
the website addresses, as of the date this document publishes in the
Federal Register, but websites are subject to change over time.)

II. Topics for Discussion at the Public Meeting

    The topics for discussion at this public meeting include the
current guidelines under development under the ICH. These guidelines
include the following:
    Topics Currently Under Regional Public Consultation (Step 3 of ICH
Process):

 S11 Nonclinical Safety Testing in Support of Development of
Pediatric Medicines
 Q12 Technical and Regulatory Considerations for Pharmaceutical
Product Lifecycle Management
 E9(R1) Addendum: Statistical Principles for Clinical Trials

    Selected Topics Recently Finalized (Step 4 of ICH Process):

 E17 General Principles on Planning/Designing Multi-Regional
Clinical Trials

    Electronic Standards and MedDRA (Medical Dictionary for Regulatory
Activities):

 M2 Electronic Standards for the Transfer of Regulatory
Information
 M8 Electronic Common Technical Document (eCTD)
 E2B Clinical Safety Data Management: Data Elements for
Transmission of Individual Case Safety Reports
 M1 MedDRA Terminology

    Additional Ongoing Topics:

 E19 Optimization of Safety Data Collection
 E8(R1) Revision on General Considerations for Clinical Trials
 E11A Pediatric Extrapolation
 E14/S7B Discussion Group on Clinical and Nonclinical
Evaluation of QT/QTc Interval Prolongation
 M9 Biopharmaceutics Classification System-Based Biowaivers
 M10 Bioanalytical Method Validation
 S1(R1) Revision on Rodent Carcinogenicity Studies for Human
Pharmaceuticals
 S5(R3) Revision on Detection of Toxicity to Reproduction for
Human Pharmaceuticals
 Q3C(R7) Impurities: Guideline for Residual Solvents
 Q3D(R1) Guideline on Elemental Impurities

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting
must register online by April 3, 2018. To register for the public
meeting, please visit the following website: https://ich_regional_consultation_2018.eventbrite.com. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting must register by April 3, 2018, midnight Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization. If time
and space permit, onsite registration on the day of the public meeting
will be provided beginning at 9:30 a.m.
    The agenda for the public meeting will be made available on the
internet at https://www.fda.gov/Drugs/NewsEvents/ucm592065.htm
approximately 2 weeks in advance of the meeting.
    If you need special accommodations due to a disability, please
contact Amanda Roache (see FOR FURTHER INFORMATION CONTACT) no later
than March 23, 2018.
    Requests for Oral Presentations: If you wish to make a presentation
during the public comment session, please contact Amanda Roache (see
FOR FURTHER INFORMATION CONTACT) no later than March 23, 2018.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations, and request time for a
joint presentation. All requests to make presentations must be received
by the close of registration on April 3, 2018. If selected for
presentation, any presentation materials must be emailed to Amanda
Roache (see FOR FURTHER INFORMATION CONTACT) no later than April 3,
2018. No commercial or promotional material will be permitted to be
presented or distributed at the public meeting. Sign-up for making a
public comment will also be available between 9 a.m. and 10 a.m. on the
day of the meeting.
    Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. To register to attend via webcast, please visit the
following website: https://ich_regional_consultation_2018.eventbrite.com. If you have never
attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a
quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this
document, as of the date this document publishes in the Federal
Register, but websites are subject to change over time.

    Dated: February 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04256 Filed 3-1-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Notices]
[Pages 8838-8840]
[FR Doc No: 2022-03347]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9368-01-OMS]

Privacy Act of 1974; System of Records

AGENCY: Office of Mission Support (OMS), Environmental Protection
Agency (EPA).

ACTION: Notice of a modified system of records.

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

SUMMARY: The U.S. Environmental Protection Agency's (EPA) Office of
Acquisition Solutions is giving notice that it proposes to modify a
system of records pursuant to the provisions of the Privacy Act of
1974. EPA's Acquisition System (EAS) is an automated contract writing
and management system with configurable workflow used to initiate,
award, modify, and track acquisition actions for the procurement of
goods and services. The system of records notice for EPA Acquisition
System (EAS) is being modified to reflect that the system is now hosted
and data stored in Unison's Amazon Web Services (AWS) cloud hosting
environment, which is Federal Risk and Authorization Management Program
(FedRAMP) authorized.

DATES: Persons wishing to comment on this system of records notice must
do so by March 18, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OMS-2020-0210, by one of the following methods:
    Federal eRulemaking Portal: https://www.regulations.gov Follow the
online instructions for submitting comments.
    Email: [email protected]. Include the Docket ID number in the
subject line of the message.
    Fax:<PHONE_NUMBER>.
    Mail: OMS Docket, Environmental Protection Agency, Mail Code:
2822T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    Hand Delivery: OMS Docket, EPA/DC, WJC West Building, Room 3334,
1301 Constitution Ave. NW, Washington, DC 20460. Such deliveries are
only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.

    Instructions: Direct your comments to Docket ID No. EPA-HQ-OMS-
2020-0210. The EPA policy is that all comments received will be
included in the public docket without change and may be made available
online at https://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Controlled Unclassified Information (CUI) or other information
for which disclosure is restricted by statute. Do not submit
information that you consider to be CUI or otherwise protected through
https://www.regulations.gov. The https://www.regulations.gov website is
an ``anonymous access'' system for EPA, which means the EPA will not
know your identity or contact information unless you provide it in the
body of your comment. Each agency determines submission requirements
within their own internal processes and standards. EPA has no
requirement to include personal information. If you send an email
comment directly to the EPA without going through https://www.regulations.gov your email 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, the EPA recommends that you include your name and other
contact information in the body of your comment. If the EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, the 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 the EPA public docket, visit the EPA Docket Center
homepage at https://www.epa.gov/dockets.
    Docket: All documents in the docket are listed in the https://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CUI or other information
for which 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 https://www.regulations.gov or in hard copy at the
OMS Docket, EPA/DC, WJC West Building, Room 3334, 1301 Constitution
Ave. NW, Washington, DC 20460.

Temporary Hours During COVID-19

    Out of an abundance of caution for members of the public and our
staff, the EPA Docket Center and Reading Room are closed to the public,
with limited exceptions, to reduce the risk of transmitting COVID-19.
Our Docket Center staff will continue to provide remote customer
service via email, phone, and webform. We encourage the public to
submit comments via https://www.regulations.gov or email, as there may
be a delay in processing mailand faxes. Hand deliveries and couriers
may be received by scheduled appointment only. For further information
on EPA Docket Center services and the current status, please visit us
online at https://www.epa.gov/dockets. The telephone number for the
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
OMS Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Please submit questions to Victor
Rodriguez, [email protected],<PHONE_NUMBER> or Richard Belles,
[email protected],<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: EAS is built using a commercial off-the-
shelf product called PRISM from Unison that includes a purchase request
form and workflow. EAS is hosted, and its data stored, in Unison's AWS
cloud hosting environment, which is FedRAMP authorized. EPA is moving
applications like EAS to the cloud for scalability and improved
security. EAS collects and stores personally identifiable information
(PII) of EPA employees who initiate acquisition actions or are assigned
to work on these actions. This information may include: Employee first
name, last name, work email, work telephone number, and Local Area
Network User Identification. This information is collected and used for
internal EPA communication purposes and approval routing of the
acquisition action. Privacy information is protected by limiting EAS
access to authenticated users. Authentication is controlled using the
agency's central authentication security controls.

SYSTEM NAME AND NUMBER:
    EPA Acquisition System (EAS), EPA-86.

SECURITY CLASSIFICATION:
    Unclassified.

SYSTEM LOCATION:
    Office of Acquisition Solutions, Environmental Protection Agency,
Ronald Reagan Building, 1200 Pennsylvania Avenue NW, Washington, DC
20460. EAS is hosted as a Software as a Service (SaaS) by Unison's
Amazon Web Services (AWS) Cloud hosting environment which is FedRAMP
authorized.

SYSTEM MANAGER(S):
    Kimberly Patrick, Director, Office of Acquisition Solutions,
Environmental Protection Agency, Ronald Reagan Building, 1200
Pennsylvania Avenue NW, Washington, DC 20460, [email protected],
202-566-2605.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    Executive Order 12072 (August 16, 1978); Federal Property and
Administrative Services Act of 1949, 40 U.S.C. 121; Office of Federal
Procurement Policy Act of 1974, 41 U.S.C. 1702.

PURPOSE(S) OF THE SYSTEM:
    EPA uses EAS to initiate, award, modify and track acquisition
actions. EAS identifies employees who initiate acquisition actions or
are assigned to work on these actions. Specifically, the system tracks
the requisitioner, contract official, contract specialist, and
approving officials for each acquisition action.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Categories of individuals covered are EPA employees including the:
(a) EPA Project Officer, i.e., the individual who is responsible for
the review and evaluation of the application or proposal and the
monitoring of a resulting contract acquisition; (b) EPA Program
Official, i.e., the individual who is responsible for review and
approval of applications or proposals for funding; (c) EPA Budget
Official, i.e., the individual who is responsible for certifying
availability of funds for approved applications or proposals; (d) EPA
Contracting Officer or Contract Specialist, i.e., individuals who are
responsible for awarding and administering contracts, and (e) EPA
Merit/Peer Reviewers, i.e., individuals who provide a written review or
evaluation of the application or proposal to the EPA Project Officer.

CATEGORIES OF RECORDS IN THE SYSTEM:
    EAS collects EPA employee first name, last name, work email, work
telephone, EPA employee ID and LAN User ID information. The system also
collects other information required for the tracking or approval of a
contract action including contract proposals, technical reviews by a
peer reviewer, records of contract awards, financial data, and other
information. EAS also collects Vendor Contact information including:
Vendor Code, Legal Name, Data Universal Numbering System (DUNS) ID (a 9
character identifier used for identifying the Vendor), Cage Code

(used to provide a standardized method of identifying a given facility
at a specific location.), address, phone number, fax number, and email
address.

RECORD SOURCE CATEGORIES:
    EAS collects EPA employee information from EPA's directory service.
Contract proposals and vendor information are collected directly from
the user via the Federal Government's System for Award Management
(SAM).

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSEM, INCLUDING CATEGORIES
OF USERS AND PURPOSES OF SUCH USES:
    The routine uses below are both related to and compatible with the
original purpose for which the information was collected. The following
general routine uses apply to this system (86 FR 62527): A, B, C, D, E,
F, G, H, I, J, K, L, and M.

POLICIES AND PRACTICES FOR STORAGE OF RECORDS:
    These records are maintained electronically on computer storage
devices located at Unison's Amazon Web Services (AWS) Cloud hosting
environments (production and disaster recovery) which are Federal Risk
and Authorization Management Program (FedRAMP) authorized. Backups will
be maintained at production and disaster recovery sites, located at
Unison's Amazon Web Services (AWS) Cloud hosting environments
(production and disaster recovery). Computer records are maintained in
a secure, password protected environment. Access to computer records is
limited to those who have a need to know. All EAS user accounts are
assigned permissions as needed based on their job functions. Permission
level assignments will allow users access only to those functions for
which they are authorized. All records are maintained in secure,
access-controlled areas or buildings.

POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:
    Records are retrieved by the first name, last name and/or User ID
of EPA employees or Vendor ID (DUNS codes) associated with contracts.

POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:
    EPA will retain and dispose of EAS records in accordance with the
National Archives and Records Administration General Records Schedule
and EPA Records Schedule 055--Contracts Management Systems. EAS records
are retained for at least 6 years after contract closeout for non-
Superfund actions, and 30 years after contract closeout for Superfund
site actions.

ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:
    Security controls used to protect personally identifiable
information in EAS are commensurate with those required for an
information system rated moderate for confidentiality, integrity, and
availability, as prescribed in NIST Special Publication, 800-53,
``Security and Privacy Controls for Information Systems and
Organizations,'' Revision 5.
    1. Administrative Safeguards: EPA personnel are required to
complete annual agency Information Security and Privacy training. EPA
personnel are instructed to lock their computers when they leave their
desks.
    2. Technical Safeguards: Electronic records are maintained in a
secure, password protected electronic system. EAS access is limited to
authorized, authenticated users. All of the system's electronic
communication utilizes Transport Layer Security (TLS) secure
communication protocol for all transactions.
    3. Physical Safeguards: All records are maintained in secure,
access-controlled areas or buildings.

RECORD ACCESS PROCEDURES:
    All requests for access to personal records should cite the Privacy
Act of 1974 and reference the type of request being made (i.e.,
access). Requests must include: (1) The name and signature of the
individual making the request; (2) the name of the Privacy Act system
of records to which the request relates; (3) a statement whether a
personal inspection of the records or a copy of them by mail is
desired; and (4) proof of identity. A full description of EPA's Privacy
Act procedures for requesting access to records is available at 40 CFR
part 16.

CONTESTING RECORD PROCEDURES:
    Requests for correction or amendment must include: (1) The name and
signature of the individual making the request; (2) the name of the
Privacy Act system of records to which the request relates; (3) a
description of the information sought to be corrected or amended and
the specific reasons for the correction or amendment; and (4) proof of
identity. A full description of EPA's Privacy Act procedures for the
correction or amendment of a record are described in EPA's Privacy Act
regulations at 40 CFR part 16.

NOTIFICATION PROCEDURES:
    Individuals who wish to be informed whether a Privacy Act system of
records maintained by EPA contains any record pertaining to them,
should make a written request to EPA, Attn: Agency Privacy Officer, MC
2831T, 1200 Pennsylvania Ave. NW, Washington, DC 20460,
[email protected]. A full description of EPA's Privacy Act procedures is
included in EPA's Privacy Act regulations at 40 CFR part 16.

EXEMPTIONS PROMULGATED FOR THE SYSTEM:
    None.

HISTORY:
    86 FR 10949 (February 23, 2021).

Vaughn Noga,
Senior Agency Official for Privacy.
[FR Doc. 2022-03347 Filed 2-15-22; 8:45 am]
BILLING CODE 6560-50-P