From: Charles Ball<EMAIL_ADDRESS>
Sent: Thursday, March 04, 2010 4:28 PM
To<EMAIL_ADDRESS>Subject: Oxidation catalyst quote

Brad, here is a general price quotation for an oxidation silencer/converter.  The price is based on a
standard horizontal silencer/converter for a 500hp engine, so less the horse power the smaller the
silencer/converter and the lower the silencer/converter price. If you have any other question,
contact me at anytime.

                      "Affordable and efficient emission reduction solutions"
                                       www.emissionsandsilencers.com

Charles Ball
Engineering Manager
<EMAIL_ADDRESS>
20322 Hufsmith-Kohrville Rd.
Tomball, TX 77375
Office:<PHONE_NUMBER>
Cell:<PHONE_NUMBER>


[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Notices]
[Page 78726]
[FR Doc No: 2015-31721]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-27-000]

Paulsboro Natural Gas Pipeline Company, LLC; Notice of
Application

    Take notice that on December 1, 2015, Paulsboro Natural Gas
Pipeline Company, LLC (PNGPC), 800 Billingsport Road, Paulsboro, New
Jersey 08066, filed an application in Docket No. CP16-27-000 under
sections 7(b) and 7(c) of the Natural Gas Act (NGA), and part 157 of
the Commission's regulations requesting authorization to relocate,
replace, remove, in part, and abandon in place, in part, an
approximately 2.4-mile, 6- and 8-inch diameter existing natural gas
pipeline between Delaware County, Pennsylvania, and Gloucester County,
New Jersey. PNGPC also requests a blanket certificate pursuant to part
157, subpart F, of the Commission's regulations, authorizing PNGPC to
engage in certain self-implementing routine construction, operation and
abandonment activities, as well as waivers of certain regulatory
requirements, including the Commission's interstate pipeline open
access, tariff, accounting, posting, and reporting requirements, all as
more fully set forth in the application which is on file with the
Commission and open to public inspection.
    Any questions regarding this application should be directed to Mark
Wilgus, Senior Community Relations Specialist, Paulsboro Natural Gas
Pipeline Company LLC, 800 Billingsport Road, Paulsboro, New Jersey
08066, or by calling<PHONE_NUMBER> (telephone) or by email at
<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 5 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    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 in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. 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.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive 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>.
    Comment Date: 5:00 p.m. Eastern Time on January 4, 2016.

    Dated: December 11, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-31721 Filed 12-16-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: March 11, 2009 (Volume 74, Number 46)]
[Notices]
[Page 10598-10599]
[DOCID:fr11mr09-92]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0060]

Guidance for Industry: Measures to Address the Risk for
Contamination by Salmonella Species in Food Containing a Peanut-Derived
Product as an Ingredient; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for Industry: Measures
to Address the Risk for Contamination by Salmonella Species in Food
Containing a Peanut-Derived Product as an Ingredient.'' This guidance
is intended to clarify for manufacturers who produce foods containing a
peanut-derived product as an ingredient that there is a risk that
Salmonella species may be present in the incoming peanut-derived
product, and to recommend measures to address that risk.

DATES: Submit written or electronic comments on agency guidances at any
time.

ADDRESSES: Submit written comments on the guidance to the Division of

Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
on the guidance to http://www.regulations.gov. Submit written requests
for single copies of the guidance to the Office of Food Safety, Center
for Food Safety and Applied Nutrition (HFS-317), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock,Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled
``Guidance for Industry: Measures to Address the Risk for Contamination
by Salmonella Species in Food Containing a Peanut-Derived Product as an
Ingredient.'' This guidance is intended to clarify for manufacturers
who produce foods containing a peanut-derived product as an ingredient
that there is a risk that Salmonella species (spp.) may be present in
the incoming peanut-derived product, and to recommend measures to
address that risk. Peanut-derived products include peanuts, peanut
butter, peanut paste, peanut meal, and peanut granules.
    In the recent past, products made from peanuts have been associated
with two large, multi-state Salmonella outbreaks. The first of these,
an outbreak of Salmonella Tennessee in 2007 linked to peanut butter,
resulted in more than 600 illnesses in 47 states (Ref. 1). More
recently, peanut butter and peanut paste have been confirmed as the
source of a large multi-state outbreak caused by Salmonella Typhimurium
(Ref. 2). Peanut-derived products that have been recalled have been
used as ingredients in other products such as cookies, crackers,
cereal, candy, and ice cream. This had led to additional recalls.
    FDA is issuing this guidance as a level 1 guidance consistent with
FDA's good guidance practices regulation Sec.  10.115 (21 CFR 10.115).
Consistent with FDA's good guidance practices regulation, the agency
will accept comment, but is implementing the guidance document
immediately in accordance with Sec.  10.115(g)(2) because the agency
has determined that prior public participation is not feasible or
appropriate in light of the need to respond expeditiously to the
current circumstances. The guidance represents the agency's current
thinking on measures to address the risk for contamination by
Salmonella spp. in foods containing a peanut-derived product as an
ingredient. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternate
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
http://www.cfsan.fda.gov/guidance.html.

IV. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. FDA, FDA Warns Consumers Not to Eat Certain Jars of Peter Pan
Peanut Butter and Great Value Peanut Butter; Product May be
Contaminated With Salmonella, FDA News, P07-21, available at http://
www.fda.gov/bbs/topics/NEWS/2007/NEW01563.html, February 14, 2007.
    2. FDA, Recall of Products Containing Peanut Butter; Salmonella
Typhimurium, available at http://www.fda.gov/oc/opacom/hottopics/
salmonellatyph.html, updated February 4, 2009.

    Dated: March 9, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-5367 Filed 3-9-09; 4:15 pm]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 15 (Wednesday, January 25, 2017)]
[Notices]
[Pages 8423-8424]
[FR Doc No: 2017-01674]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10887-028]

Carthage Specialty Paperboard, Inc.; Notice of Intent To File
License Application, Filing of Pre-Application Document, and Approving
Use of the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 10887-028.
    c. Date Filed: October 28, 2016.
    d. Submitted By: Carthage Specialty Paperboard, Inc.
    e. Name of Project: Carthage Paper Makers Mill Project.
    f. Location: On the Black River, in Jefferson and Lewis Counties
New York. No federal lands are occupied by the project works or located
within the project boundary.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Mr. Fred Goutremout, 30 Champion
Street, Carthage, New York 13619, Phone:<PHONE_NUMBER>.
    i. FERC Contact: Gaylord Hoisington<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Carthage Specialty Paperboard, Inc. filed its request to use the
Traditional Licensing Process on October 28, 2016. Carthage Specialty
Paperboard, Inc. provided public notice of its request on November 4,
2016. In a letter dated January 18, 2017, the Director of the Division
of Hydropower Licensing approved Carthage Specialty Paperboard, Inc.'s
request to use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and/or NOAA Fisheries under section
7 of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the New York State Historic Preservation Officer, as
required by section 106, National Historic Preservation Act, and the
implementing regulations of the Advisory Council on Historic
Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Carthage Specialty
Paperboard, Inc. as the Commission's non-federal representative for
carrying out informal consultation pursuant to section 7 of the
Endangered Species Act and section 305(b) of the Magnuson-Stevens
Fishery Conservation and Management Act; and consultation pursuant to
section 106 of the National Historic Preservation Act.
    m. Carthage Specialty Paperboard, Inc. filed a Pre-Application
Document (PAD; including a proposed process plan and schedule) with the
Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(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 Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659

(TTY). A copy is also available for inspection and reproduction at the
address in paragraph h.
    o. The licensee states its unequivocal intent to submit an
application for a new license for Project No. 10887-028. Pursuant to 18
CFR 16.8, 16.9, and 16.10 each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by October 31,
2019.
    p. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: January 18, 2017.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2017-01674 Filed 1-24-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 241 (Tuesday, December 15, 2020)]
[Notices]
[Page 81193]
[FR Doc No: 2020-27531]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP21-6-000]

Spire Storage West, LLC; Notice of Schedule for the Preparation
of an Environmental Assessment for the Clear Creek Expansion Project

    On October 9, 2020, Spire Storage West, LLC (Spire Storage) filed
an application in Docket No. CP21-6-000 requesting a Certificate of
Public Convenience and Necessity pursuant to Section 7(c) of the
Natural Gas Act to construct and operate certain natural gas pipeline
facilities. The proposed project is known as the Clear Creek Expansion
Project (Project), and would expand Spire Storage's natural gas storage
facilities in Uinta County, Wyoming in order to increase the
certificated gas capacities from 4.0 billion cubic feet (Bcf) to 20
Bcf, and increase the maximum daily injection and withdrawal capacities
from 35 million cubic feet (MMcf) and 50 MMcf per day, to 350 MMcf and
500 MMcf per day, respectively.
    On October 22, 2020, the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Project.
Among other things, that notice alerted agencies issuing federal
authorizations of the requirement to complete all necessary reviews and
to reach a final decision on a request for a federal authorization
within 90 days of the date of issuance of the Commission staff's
environmental document for the Project.
    This notice identifies Commission staff's intention to prepare an
environmental assessment (EA) for the Project and the planned schedule
for the completion of the environmental review.\1\
---------------------------------------------------------------------------

    \1\ 40 CFR 1501.10 (2020).
---------------------------------------------------------------------------

Schedule for Environmental Review

Issuance of EA May 13, 2021
90-day Federal Authorization Decision Deadline August 11, 2021

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    The Clear Creek Expansion Project would consist of the following
facilities in Uinta County, Wyoming:
     Four compressor units at the Clear Creek Plant;
     a tank storage and natural gas liquids fueling equipment
facility on an existing pad;
     11 new injection/withdrawal wells, one new water disposal
well, and associated lines;
     approximately 10.6 miles of 20-inch-diameter pipeline;
     approximately 3.5 miles of 4,160-volt powerline; and
     other related appurtenances.

Background

    On November 9, 2020, the Commission issued a Notice of Scoping
Period Requesting Comments on Environmental Issues for the Proposed
Clear Creek Expansion Project (Notice of Scoping). The Notice of
Scoping was sent to affected landowners; federal, state, and local
government agencies; elected officials; environmental and public
interest groups; Native American tribes; other interested parties; and
local libraries and newspapers. In response to the Notice of Scoping,
the Commission received comments from the Wyoming Department of
Environmental Quality. The primary issues raised by the commenter are
permitting, stream crossings, wetland impacts, and spill reporting. All
substantive comments will be addressed in the EA.
    The U.S. Bureau of Land Management is a cooperating agency in the
preparation of the EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of formal issuances and submittals in specific dockets, the
Commission offers a free service called eSubscription. This service
provides automatic notification of filings made to subscribed dockets,
document summaries, and direct links to the documents. Go to https://www.ferc.gov/ferc-online/overview to register for eSubscription.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the ``eLibrary'' link, select
``General Search'' from the eLibrary menu, enter the selected date
range and ``Docket Number'' excluding the last three digits (i.e.,
CP21-6), and follow the instructions. For assistance with access to
eLibrary, the helpline can be reached at<PHONE_NUMBER>, TTY (202) 502-
8659, or at<EMAIL_ADDRESS>The eLibrary link on the FERC
website also provides access to the texts of formal documents issued by
the Commission, such as orders, notices, and rule makings.

    Dated: December 9, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-27531 Filed 12-14-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 11, 2008 (Volume 73, Number 71)]
[Notices]
[Page 19930]
[DOCID:fr11ap08-131]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

 Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System or Relief From the
Requirements of Title 49 Code of Federal Regulations Part 236

    Pursuant to Title 49 Code of Federal Regulations (CFR) Part 235 and
49 U.S.C. 20502(a), the following railroad has petitioned the Federal
Railroad Administration (FRA) seeking approval for the discontinuance
or modification of the signal system or relief from the requirements of
49 CFR Part 236, as detailed below.

Docket Number FRA-2008-0011

    Applicant: New York, Susquehanna and Western Railway Corporation,
Mr. Nathan R. Fenno, President, 1 Railroad Avenue, Cooperstown, New
York 13326.
    The New York, Susquehanna and Western Railway Corporation seeks
approval of the proposed discontinuance and removal of the interlocking
signal system at CP Forks, Milepost (MP) 201 to MP 205 and MP 203.62 to
MP 205 on two main lines originating in Binghamton, New York, the
Syracuse Main Line and the Utica Main Line.
    The reason given for the proposed changes is that since June 2006,
the Utica Main Line has been out of service from MP 205 to MP 243.51
due to extensive flooding. The Utica Main Line from MP 202.62 to MP 205
is used as a storage spur under the Maintenance of Way supervision.
    Any interested party desiring to protest the granting of an
application shall set forth specifically the grounds upon which the
protest is made, and include a concise statement of the interest of the
party in the proceeding. Additionally, one copy of the protest shall be
furnished to the applicant at the address listed above.
    FRA expects to be able to determine these matters without an oral
hearing. However, if a specific request for an oral hearing is
accompanied by a showing that the party is unable to adequately present
his or her position by written statements, an application may be set
for public hearing.
    All communications concerning this proceeding should be identified
by Docket Number FRA-2008-0011 and may be submitted by one of the
following methods:
     Web site: http://www.regulations.gov. Follow the
instructions for submitting comments on the DOT electronic site;
     Fax:<PHONE_NUMBER>;
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590; or
     Hand Delivery: Room W12-140 of the U.S. Department of
Transportation West Building Ground Floor, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    FRA wishes to inform all potential commenters that anyone is able
to search the electronic form of all comments received into any of our
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review DOT's complete Privacy Act
Statement in the Federal Register published on April 11, 2000 (Volume
65, Number 70; Pages 19477-78) or you may visit http://dms.dot.gov.

    Issued in Washington, DC, on April 7, 2008.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
 [FR Doc. E8-7681 Filed 4-10-08; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register: December 4, 2009 (Volume 74, Number 232)]
[Notices]
[Page 63747-63748]
[DOCID:fr04de09-71]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1864-003]

Upper Peninsula Power Company; Notice of Intent To Prepare an
Environmental Document and Soliciting Comments

November 25, 2009.
    Take notice that the following material addressing required dam
safety measures has been filed with the Commission and is available for
public inspection:
    a. Filing: Environmental report to support replacement of the
spillway at the Bond Falls Development which is being required under
Part 12 of the Commission's regulations.
    b. Project No: 1864-003.
    c. Date Filed: August 21, 2009, and supplemented on November 17,
2009.
    d. Licensee: Upper Peninsula Power Company.
    e. Name of Project: Bond Falls Hydroelectric Project.
    f. Location: The Bond Falls Hydroelectric Project is located on the
Ontonagon River in Ontonagon and Gogebic Counties, Michigan, and Vilas
county, Wisconsin, partially on lands within the Ottawa National
Forest. The Bond Falls Development is located on the Middle Branch of
the Ontonagon River in Ontonagon County, Michigan, and occupies 73.5
acres of land within the Ottawa National Forest.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Licensee Contact: Rick Moser, Upper Peninsula Power Company, 700
North Adams Street, P.O. Box 19001, Green Bay, WI 54307-9001, (920)
433-2290.
    i. FERC Contact: Rachel Price,<PHONE_NUMBER>, and e-mail:
<EMAIL_ADDRESS>    j. Deadline for filing comments: December 28, 2009.
    All documents should be filed with: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Comments may be filed electronically via the
Internet, see 18 CFR 385.2001 (a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-filing'' link. The Commission
strongly encourages electronic filings. In lieu of electronic filing,
an original and eight copies of all documents may be mailed to the
Secretary at the address above.
    k. Description of material: Upper Peninsula Power Company has filed
an Environmental Report in support of its plan to replace the spillway
at the Bond

Falls Development, part of the Bond Falls Hydroelectric Project (FERC
No. 1864). The project consists of four separate developments: Bond
Falls, Bergland, Cicso, and Victoria. The proposed work at the Bond
Falls spillway would take place within the Bond Falls Development which
is on the Middle Branch of the Ontonagon River. The Bond Falls
reservoir is operated to store water and divert river flow from the
Middle Branch to the South Branch of the Ontonagon River. A recent
hydraulic study determined that the existing spillway capacity is
inadequate to pass the flows associated with the calculated Probable
Maximum Flood (PMF) for the project location. To ensure the licensee's
compliance with FERC engineering guidelines and safety regulations,
modifications to the spillway are necessary. The licensee plans to
replace the existing spillway with a new spillway incorporating two
larger tainter gates at a lower sill elevation. In addition, the
licensee plans to replace the existing low level outlet with a new low
level structure incorporated into the new spillway, and raise the
embankment crest in low areas of the main, auxiliary, and control dams
of the Bond Falls Development. In order to complete construction, the
licensee plans to drawdown the reservoir to an elevation of 1455.8 feet
North American Vertical Datum of 1988, and maintain the reservoir at
that elevation during all of 2010. In addition the spillway replacement
construction activities will result in the temporary closure of some of
the project's recreational facilities during 2010.
    The Commission intends to prepare an environmental document under
the National Environmental Policy Act (NEPA) for the planned Bond Falls
spillway replacement. The NEPA document will be used by the Commission
to identify environmental impacts and to identify measures that would
help mitigate the impacts caused by the activities associated with the
spillway replacement.
    l. Locations of the Filing: A copy of the filing is available for
inspection and reproduction at the Commission's Public Reference Room,
located at 888 First Street, NE., Room 2A, Washington, DC 20426. This
filing may also be viewed on the Commission's Web site at http://
www.ferc.gov using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. You may also register online at http://www.ferc.gov/docs-
filing/esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
call 1-866-208-3676 or e-mail<EMAIL_ADDRESS>for TTY, call
(202) 502-8659.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments: Anyone may submit comments on the material described
in this notice. In completing its environmental review, the Commission
will consider all comments filed. Any comments must be received on or
before deadline for filing comments specified above.
    o. Any filing made with the Commission in response to this notice
must bear in all capital letters the title ``COMMENTS'' and the Project
Number: P-1864-003.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the material described in this notice. A copy of
the filing may be obtained by agencies directly from the licensee. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the licensee's representatives.
    q. Comments may be filed electronically via the Internet in lieu of
paper. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site at http://www.ferc.gov under the ``e-Filing''
link.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-28921 Filed 12-3-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 25 (Thursday, February 6, 2020)]
[Notices]
[Pages 6955-6957]
[FR Doc No: 2020-02371]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0118]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Prior Notice of Imported Food Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of our regulations requiring that the Agency receive prior
notice before food is imported or offered for import into the United
States.

DATES: Submit either electronic or written comments on the collection
of information by April 6, 2020.

ADDRESSES: 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 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 6, 2020. 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 (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-2010-N-0118 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Prior Notice of Imported Food
Under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002.'' 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.govinfo.gov/content/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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an

existing collection of information, before submitting the collection to
OMB for approval. To comply with this requirement, FDA is publishing
notice of the proposed collection of information set forth in this
document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002--21 CFR 1.278 to
1.285

OMB Control Number 0910-0520--Extension

    The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (Bioterrorism Act) added section 801(m) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(m)),
which requires that FDA receive prior notice for food, including food
for animals, that is imported or offered for import into the United
States. Sections 1.278 to 1.282 of FDA regulations (21 CFR 1.278 to
1.282) set forth the requirements for submitting prior notice;
Sec. Sec.  1.283(d) and 1.285(j) (21 CFR 1.283(d) and 1.285(j)) set
forth the procedure for requesting Agency review after FDA has refused
admission of an article of food under section 801(m)(1) of the FD&C Act
or placed an article of food under hold under section 801(l) of the
FD&C Act; and Sec.  1.285(i) sets forth the procedure for post-hold
submissions.
    Section 304 of the FDA Food Safety Modernization Act (Pub. L. 111-
353) amended section 801(m) of the FD&C Act to require a person
submitting prior notice of imported food, including food for animals,
to report, in addition to other information already required, ``any
country to which the article has been refused entry.'' Advance notice
of imported food allows FDA, with the support of the U.S. Customs and
Border Protection (CBP), to target import inspections more effectively
and help protect the nation's food supply against terrorist acts and
other public health emergencies. By requiring that a prior notice
contain specific information that indicates prior refusals by any
country and identifies the country or countries, the Agency may better
identify imported food shipments that may pose safety and security
risks to U.S. consumers.
    This information collection enables FDA to make better informed
decisions in managing the potential risks of imported food shipments
into the United States. Any person with knowledge of the required
information may submit prior notice for an article of food. Thus, the
respondents to this information collection may include importers,
owners, ultimate consignees, shippers, and carriers.
    FDA regulations require that prior notice of imported food be
submitted electronically using CBP's Automated Broker Interface of the
Automated Commercial System (ABI/ACS) (Sec.  1.280(a)(1)) or the FDA
Prior Notice System Interface (PNSI) (Form FDA 3540) (Sec.
1.280(a)(2)). PNSI is an electronic submission system available on the
FDA Industry Systems page at http://www.access.fda.gov/. Information
the Agency collects in the prior notice submission includes: (1) The
submitter and transmitter (if different from the submitter); (2) entry
type and CBP identifier; (3) the article of food, including complete
FDA product code; (4) the manufacturer, for an article of food no
longer in its natural state; (5) the grower, if known, for an article
of food that is in its natural state; (6) the FDA Country of
Production; (7) the name of any country that has refused entry of the
article of food; (8) the shipper, except for food imported by
international mail; (9) the country from which the article of food is
shipped or, if the food is imported by international mail, the
anticipated date of mailing and country from which the food is mailed;
(10) the anticipated arrival information or, if the food is imported by
international mail, the U.S. recipient; (11) the importer, owner, and
ultimate consignee, except for food imported by international mail or
transshipped through the United States; (12) the carrier and mode of
transportation, except for food imported by international mail; and
(13) planned shipment information, except for food imported by
international mail (Sec.  1.281).
    Much of the information collected for prior notice is identical to
the information collected for FDA importer's entry notice, which has
been approved under OMB control number 0910-0046. The information in an
importer's entry notice is collected electronically via CBP's ABI/ACS
at the same time the respondent files an entry for import with CBP. To
avoid double-counting the burden hours already counted in the
importer's entry notice information collection, the burden hour
analysis in table 1 reflects FDA's estimate of the reduced burden for
prior notice submitted through ABI/ACS in column 6 entitled ``Average
Burden per Response.''
    In addition to submitting a prior notice, a submitter should cancel
a prior notice and must resubmit the information to FDA if information
changes after the Agency has confirmed a prior notice submission for
review (e.g., if the identity of the manufacturer changes) (Sec.
1.282). However, changes in the estimated quantity, anticipated arrival
information, or planned shipment information do not require
resubmission of prior notice after the Agency has confirmed a prior
notice submission for review (Sec.  1.282(a)(1)(i) to (iii)). In the
event that FDA refuses admission to an article of food under section
801(m)(1) or the Agency places it under hold under section 801(l) of
the FD&C Act, Sec. Sec.  1.283(d) and 1.285(j) set forth the procedure
for requesting FDA's review and the information required in a request
for review. In the event that the Agency places an article of food
under hold under Sec.  801(l) of the FD&C Act, Sec.  1.285(i) sets
forth the procedure for, and the information to be included in, a post-
hold submission.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                               Number of
              21 CFR section                 FDA form No.      Number of     responses per   Total annual    Average burden per response    Total hours
                                                              respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Prior Notice Submissions: Through ABI/ACS
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1.280 through 1.281.......................             N/A           1,700           7,647      12,999,900  0.167 (10 minutes)..........   \2\ 2,170,983
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Through PNSI
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1.280 through 1.281.......................        3540 \3\          27,000              70       1,890,000  0.384 (23 minutes)..........         725,760
                                           -------------------------------------------------------------------------------------------------------------
    Subtotal..............................  ..............  ..............  ..............  ..............  ............................       2,896,743
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Cancellations: Through ABI/ACS
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.282.....................................            3540           7,040               1           7,040  0.25 (15 minutes)...........           1,760
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                                                                      Through PNSI
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1.282 and 1.283(a)(5).....................            3540          35,208               1          35,208  0.25 (15 minutes)...........           8,802
                                           -------------------------------------------------------------------------------------------------------------
    Subtotal..............................  ..............  ..............  ..............  ..............  ............................          10,562
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Requests for Review and Post-hold Submissions
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1.283(d) and 1.285(j).....................             N/A               1               1               1  8...........................               8
1.285(i)..................................             N/A             263               1             263  1...........................             263
                                           -------------------------------------------------------------------------------------------------------------
    Subtotal..............................  ..............  ..............  ..............  ..............  ............................             271
                                           -------------------------------------------------------------------------------------------------------------
        Total.............................  ..............  ..............  ..............      14,932,412  ............................       2,907,576
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ To avoid double-counting, an estimated 396,416 burden hours already accounted for in the Importer's Entry Notice information collection approved
  under OMB control number 0910-0046 are not included in this total.
\3\ The term ``Form FDA 3540'' refers to the electronic submission system known as PNSI, which is available at https://www.access.fda.gov.

    Based on our experience and the average number of prior notice
submissions, cancellations, and requests for review received in the
past 3 years, we have made no adjustments in our burden estimate for
the information collection. We estimate that 1,700 users of ABI/ACS
will submit an average of 7,647 prior notices annually, for a total of
12,999,900 prior notices received through ABI/ACS. We assume the
reporting burden for a prior notice submitted through ABI/ACS to be 10
minutes, or 0.167 hour, per notice, for a total annual burden of
2,170,983 hours. This estimate takes into consideration the burden
hours already counted in the information collection approval for FDA
importer's entry notice (OMB control number 0910-0046), as previously
discussed.
    We estimate that 27,000 registered users of PNSI will submit an
average of 70 prior notices annually, for a total of 1,890,000 prior
notices received annually. We assume the reporting burden for a prior
notice submitted through PNSI to be 23 minutes, or 0.384 hour, per
notice, for a total burden of 725,760 hours.
    We estimate that 7,040 users of ABI/ACS will submit an average of 1
cancellation annually, for a total of 7,040 cancellations received
annually through ABI/ACS. We assume the reporting burden for a
cancellation submitted through ABI/ACS to be 15 minutes, or 0.25 hour,
per cancellation, for a total burden of 1,760 hours.
    We estimate that 35,208 registered users of PNSI will submit an
average of 1 cancellation annually, for a total of 35,208 cancellations
received annually. We assume the reporting burden for a cancellation
submitted through PNSI to be 15 minutes, or 0.25 hour, per
cancellation, for a total burden of 8,802 hours.
    We estimate that one or fewer requests for review under Sec.
1.283(d) or Sec.  1.285(j) will be submitted annually. We assume that
it will take respondents 8 hours to prepare the factual and legal
information necessary to prepare a request for review. Thus, we
estimate a total reporting burden of 8 hours.
    We estimate that 263 post-hold submissions under Sec.  1.285(i)
will be submitted annually. We assume that it will take about 1 hour to
prepare the written notification described in Sec.  1.285(i)(2)(i), for
a total reporting burden of 263 hours.

    Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02371 Filed 2-5-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Notices]
[Page 18330]
[FR Doc No: 2013-06784]

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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: RP13-686-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Negotiated Rate-Tenaska to be effective 3/18/2013.
    Filed Date: 3/18/13.
    Accession Number: 20130318-5081.
    Comments Due: 5 p.m. ET 4/1/13.

    Docket Numbers: RP13-687-000.
    Applicants: Cameron Interstate Pipeline, LLC.
    Description: Cameron Interstate Pipeline LLC Annual Report of
Penalty Revenues.
    Filed Date: 3/18/13.
    Accession Number: 20130318-5082.
    Comments Due: 5 p.m. ET 4/1/13.

    Docket Numbers: RP13-688-000.
    Applicants: Cameron Interstate Pipeline, LLC.
    Description: Cameron Interstate Pipeline LLC Annual Report of
Interruptible Transportation Revenue Sharing.
    Filed Date: 3/18/13.
    Accession Number: 20130318-5083.
    Comments Due: 5 p.m. ET 4/1/13.

    Docket Numbers: RP13-689-000.
    Applicants: Cameron Interstate Pipeline, LLC.
    Description: Cameron Interstate Pipeline LLC Annual Report of
Operational Imbalances and Cash-out Activity.
    Filed Date: 3/18/13.
    Accession Number: 20130318-5086.
    Comments Due: 5 p.m. ET 4/1/13.

    Docket Numbers: RP13-690-000.
    Applicants: Cameron Interstate Pipeline, LLC.
    Description: Cameron Interstate Pipeline LLC Annual Report of
Transportation Imbalances and Cash-out Activity.
    Filed Date: 3/18/13.
    Accession Number: 20130318-5087.
    Comments Due: 5 p.m. ET 4/1/13.

    Docket Numbers: RP13-691-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America LLC submits
tariff filing per 154.204: Tenaska Negotiated Rate Amendment to be
effective 3/18/2013.
    Filed Date: 3/18/13.
    Accession Number: 20130318-5097.
    Comments Due: 5 p.m. ET 4/1/13.

    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.

Filings in Existing Proceedings

    Docket Numbers: RP10-782-002.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Offsystem Pipeline Capacity Compliance Filing in RP10-
782 to be effective 5/1/2010.
    Filed Date: 3/18/13.
    Accession Number: 20130318-5100.
    Comments Due: 5 p.m. ET 4/1/13.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service 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 (202) 502-
8659.

    Dated: March 19, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-06784 Filed 3-25-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Rules and Regulations]
[Pages 52973-52975]
[FR Doc No: 2018-22785]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2018-N-3634]

Medical Devices; Ophthalmic Devices; Classification of the
Intranasal Electrostimulation Device for Dry Eye Symptoms

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is

classifying the intranasal electrostimulation device for dry eye
symptoms into class II (special controls). The special controls that
apply to the device type are identified in this order and will be part
of the codified language for the intranasal electrostimulation device
for dry eye symptoms' classification. We are taking this action because
we have determined that classifying the device into class II (special
controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices, in part by reducing
regulatory burdens.

DATES: This order is effective October 19, 2018. The classification was
applicable on May 17, 2018.

FOR FURTHER INFORMATION CONTACT: Elvin Ng, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2431, Silver Spring, MD, 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the intranasal electrostimulation
device for dry eye symptoms as class II (special controls), which we
have determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application to market a substantially equivalent
device (see 21 U.S.C. 360c(i), defining ``substantial equivalence'').
Instead, sponsors can use the less-burdensome 510(k) process, when
necessary, to market their device.

II. De Novo Classification

    On October 23, 2017, Allergan submitted a request for De Novo
classification of the TrueTear Intranasal Tear Neurostimulator. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on May 17, 2018, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 886.5310. We have named
the generic type of device intranasal electrostimulation device for dry
eye symptoms, and it is identified as a prescription non-implantable,
electrostimulation device intended to increase tear production for
improvement in dry eye symptoms.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

Table 1--Intranasal Electrostimulation Device for Dry Eye Symptoms Risks
                         and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Tissue damage due to overstimulation/    Non-clinical performance
 understimulation or mechanical injury    testing; Software
 (ex: tips too long), device breakage.    verification, validation, and
                                          hazard analysis; Electrical,
                                          thermal, and mechanical safety
                                          testing; and Labeling.

Adverse tissue reaction................  Biocompatibility evaluation and
                                          Labeling.
Infection..............................  Labeling.
Electrical shock or burn...............  Electrical, thermal, and
                                          mechanical safety testing;
                                          Software verification,
                                          validation, and hazard
                                          analysis; and Labeling.
Interference with other devices........  Electromagnetic compatibility
                                          (EMC) testing; Software
                                          verification, validation, and
                                          hazard analysis; and Labeling.
Pain, headache, or discomfort..........  Clinical performance testing;
                                          Non-clinical performance
                                          testing; Electrical, thermal,
                                          and mechanical safety testing;
                                          and Labeling.
Failure to mitigate dry eye symptoms...  Clinical performance testing,
                                          Training, and Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k).
    At the time of classification, intranasal electrostimulation
devices for dry eye symptoms are for prescription use only.
Prescription devices are exempt from the requirement for adequate
directions for use for the layperson under section 502(f)(1) of the
FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the
conditions of 21 CFR 801.109 are met (referring to 21 U.S.C.
352(f)(1)).

III. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in 21 CFR part 820, regarding
quality system regulation, have been approved under OMB control number
0910-0073; the collections of information in part 807, subpart E,
regarding premarket notification submissions, have been approved under
OMB control number 0910-0120; and the collections of information in 21
CFR part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
886 is amended as follows:

PART 886--OPHTHALMIC DEVICES

0
1. The authority citation for part 886 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  886.5310 to subpart F to read as follows:

Sec.  886.5310  Intranasal electrostimulation device for dry eye
symptoms.

    (a) Identification. An intranasal electrostimulation device for dry
eye symptoms is a prescription non-implantable, electrostimulation
device intended to increase tear production for improvement in dry eye
symptoms.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Clinical performance testing must evaluate improvement of dry
eye symptoms under anticipated conditions of use.
    (2) Non-clinical performance testing must assess the following
electrical output specifications: waveforms, output modes, maximum
output voltage, maximum output current, pulse duration, frequency, net
charge per pulse, maximum phase charge at 500 ohms, maximum current
density, maximum average current, and maximum average power density.
    (3) Patient-contacting components of the device must be
demonstrated to be biocompatible.
    (4) Performance testing must demonstrate the electrical, thermal,
and mechanical safety along with electromagnetic compatibility (EMC) of
the device in the intended use environment.
    (5) Software verification, validation, and hazard analysis must be
performed.
    (6) Training for the proper use of the device must be provided.
    (7) Physician and patient labeling must include:
    (i) Summaries of electrical stimulation parameters;
    (ii) Instructions on how to correctly use and maintain the device;
    (iii) Instructions and explanations of all user-interface
components;
    (iv) Information related to electromagnetic compatibility
classification;
    (v) Instructions on how to clean the device; and
    (vi) Summaries of clinical performance testing demonstrating safety
and effectiveness.

    Dated: October 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22785 Filed 10-18-18; 8:45 am]
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[Federal Register Volume 79, Number 75 (Friday, April 18, 2014)]
[Notices]
[Page 21913]
[FR Doc No: 2014-08866]

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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: PR14-33-000.
    Applicants: Rocky Mountain Natural Gas LLC.
    Description: Tariff filing per 284.123(b)(1)/.: Revised Statement
of Operating Conditions effective 3/1/2014; TOFC: 980.
    Filed Date: 3/28/14.5
    Accession Number: 20140328-5171.
    Comments Due: 5 p.m. ET 4/18/14.

    Docket Numbers: RP14-713-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Amendment to Neg Rate Agmt (Devon 34694-53) to be
effective 4/2/2014.
    Filed Date: 4/2/14.
    Accession Number: 20140402-5126.
    Comments Due: 5 p.m. ET 4/14/14.

    Docket Numbers: RP14-714-000.
    Applicants: East Tennessee Natural Gas, LLC.
    Description: Duke Energy 4-1-2014 release to be effective 4/1/2014.
    Filed Date: 4/2/14.
    Accession Number: 20140402-5129.
    Comments Due: 5 p.m. ET 4/14/14.

    Docket Numbers: RP14-715-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Volume No. 2--Boston Gas and Narragansett Electric--
Amend Exhibit A to be effective 4/1/2014.
    Filed Date: 4/3/14.
    Accession Number: 20140403-5020.
    Comments Due: 5 p.m. ET 4/15/14.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    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.
    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: April 3, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-08866 Filed 4-17-14; 8:45 am]
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[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Notices]
[Pages 70147-70149]
[FR Doc No: 2020-24478]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0499; FRL-10015-51]

Carbon Tetrachloride (CCl4); Final Toxic Substances Control Act
(TSCA) Risk Evaluation; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of the final Toxic Substances Control Act (TSCA) risk
evaluation of Carbon Tetrachloride (CCl4). The purpose of
conducting risk evaluations under TSCA is to determine whether a
chemical substance presents an unreasonable risk of injury to health or
the environment under the conditions of use, including an unreasonable
risk to a relevant potentially exposed or susceptible subpopulation,
without consideration of

costs or other nonrisk factors. EPA has determined that specific
conditions of use of CCl4 present an unreasonable risk of
injury to health or the environment. For those conditions of use for
which EPA has found an unreasonable risk, EPA must take regulatory
action to address that unreasonable risk through risk management
measures enumerated in TSCA. EPA has also determined that specific
conditions of use do not present unreasonable risk of injury to health
or the environment. For those conditions of use for which EPA has found
no unreasonable risk to health or the environment, the Agency's
determination is a final Agency action and is issued via order in the
risk evaluation.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2019-0499, is available online
at http://www.regulations.gov or in-person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket), Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Public Reading Room are closed to visitors
with limited exceptions. The EPA/DC staff continue to provide remote
customer service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Dr. Karen Eisenreich, Office of
Pollution Prevention and Toxics (7403M), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may
be of interest to persons who are or may be interested in risk
evaluations of chemical substances under TSCA, 15 U.S.C. 2601 et seq.
Since other entities may also be interested in this final risk
evaluation, the EPA has not attempted to describe all the specific
entities that may be affected by this action.

B. What is EPA's authority for taking this action?

    TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct risk
evaluations to ``determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment, without
consideration of costs or other nonrisk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation by the Administrator,
under the conditions of use.'' 15 U.S.C. 2605(b)(4)(A). TSCA sections
6(b)(4)(A) through (H) enumerate the deadlines and minimum requirements
applicable to this process, including provisions that provide
instruction on chemical substances that must undergo evaluation, the
minimum components of a TSCA risk evaluation, and the timelines for
public comment and completion of the risk evaluation. TSCA also
requires that EPA operate in a manner that is consistent with the best
available science, make decisions based on the weight of the scientific
evidence and consider reasonably available information. 15 U.S.C.
2625(h), (i), and (k). TSCA section 6(i) directs that a determination
of ``no unreasonable risk'' shall be issued by order and considered to
be a final Agency action, while a determination of ``unreasonable
risk'' is not considered to be a final Agency action. 15 U.S.C.
2605(i).
    The statute identifies the minimum components for all chemical
substance risk evaluations. For each risk evaluation, EPA must publish
a document that outlines the scope of the risk evaluation to be
conducted, which includes the hazards, exposures, conditions of use,
and the potentially exposed or susceptible subpopulations that EPA
expects to consider. 15 U.S.C. 2605(b)(4)(D). The statute further
provides that each risk evaluation must also: (1) Integrate and assess
available information on hazards and exposures for the conditions of
use of the chemical substance, including information that is relevant
to specific risks of injury to health or the environment and
information on relevant potentially exposed or susceptible
subpopulations; (2) describe whether aggregate or sentinel exposures
were considered and the basis for that consideration; (3) take into
account, where relevant, the likely duration, intensity, frequency, and
number of exposures under the conditions of use; and (4) describe the
weight of the scientific evidence for the identified hazards and
exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through
(v). Each risk evaluation must not consider costs or other nonrisk
factors. 15 U.S.C. 2605(b)(4)(F)(iii).
    The statute requires that the risk evaluation process be completed
within a specified timeframe and provide an opportunity for public
comment on a draft risk evaluation prior to publishing a final risk
evaluation. 15 U.S.C. 2605(b)(4).
    Subsection 5.4.1 of the final risk evaluation for CCl4
constitutes the order required under TSCA section 6(i)(1), and the ``no
unreasonable risk'' determinations in that subsection are considered to
be a final Agency action effective on the date of issuance of the
order. In conducting risk evaluations, ``EPA will determine whether the
chemical substance presents an unreasonable risk of injury to health or
the environment under each condition of use within the scope of the
risk evaluation . . . .'' 40 CFR 702.47. Under EPA's implementing
regulations, ``[a] determination by EPA that the chemical substance,
under one or more of the conditions of use within the scope of the risk
evaluation, does not present an unreasonable risk of injury to health
or the environment will be issued by order and considered to be a final
Agency action, effective on the date of issuance of the order.'' 40 CFR
702.49(d). For purposes of TSCA section 19(a)(1)(A), the date of
issuance of the TSCA section 6(i)(1) order for CCl4 shall be
at 1:00 p.m. Eastern time (standard or daylight, as appropriate) on the
date that is two weeks after the date when this notice is published in
the Federal Register, which is in accordance with 40 CFR 23.5.

C. What action is EPA taking?

    EPA is announcing the availability of the risk evaluation of the
chemical substance identified in Unit II. In this risk evaluation EPA
has made unreasonable risk determinations on some of the conditions of
use within the scope of the risk evaluation for this chemical. For
those conditions of use for which EPA has found an unreasonable risk of
injury to health or the environment, EPA must initiate regulatory
action to address those risks

through risk management measures enumerated in 15 U.S.C. 2605(a).
    EPA also is announcing the availability of the information required
to be provided publicly with each risk evaluation, which is available
online at http://www.regulations.gov in the dockets identified. 40 CFR
702.51. Specifically, EPA has provided:
     The scope document and problem formulation (in Docket ID
No. EPA-HQ-OPPT-2016-0733);
     Draft risk evaluation, and final risk evaluation (in
Docket ID No. EPA-HQ-OPPT-2019-0499);
     All notices, determinations, findings, consent agreements,
and orders (in Docket ID No. EPA-HQ-OPPT-2019-0499);
     Any information required to be provided to the Agency
under 15 U.S.C. 2603 (in Docket ID No. EPA-HQ-OPPT-2016-0733 and Docket
ID No. EPA-HQ-OPPT-2019-0499);
     A nontechnical summary of the risk evaluation (in Docket
ID No. EPA-HQ-OPPT-2019-0499);
     A list of the studies, with the results of the studies,
considered in carrying out each risk evaluation (Risk Evaluation for
Carbon Tetrachloride (CCl4)) in Docket ID No. EPA-HQ-OPPT-
2019-0499);
     The final peer review report, including the response to
peer review and public comments received during peer review (in Docket
ID No. EPA-HQ-OPPT-2019-0499); and
     Response to public comments received on the draft scope
and the draft risk evaluation (in Docket ID No. EPA-HQ-OPPT-2019-0499).

II. TSCA Risk Evaluation

A. What is EPA's risk evaluation process for existing chemicals under
TSCA?

    The risk evaluation process is the second step in EPA's existing
chemical review process under TSCA, following prioritization and before
risk management. As this chemical is one of the first ten chemical
substances undergoing risk evaluation, the chemical substance was not
required to go through prioritization (81 FR 91927, December 19, 2016)
(FRL-9956-47). The purpose of conducting risk evaluations is to
determine whether a chemical substance presents an unreasonable risk of
injury to health or the environment under the conditions of use,
including an unreasonable risk to a relevant potentially exposed or
susceptible subpopulation. As part of this process, EPA must evaluate
both hazard and exposure, not consider costs or other nonrisk factors,
use reasonably available information and approaches in a manner that is
consistent with the requirements in TSCA for the use of the best
available science, and ensure decisions are based on the weight of the
scientific evidence.
    The specific risk evaluation process that EPA has established by
rule to implement the statutory process is set out in 40 CFR part 702
and summarized on EPA's website at http://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca. As explained in the preamble to EPA's final rule on
procedures for risk evaluation (82 FR 33726, July 20, 2017) (FRL-9964-
38), the specific regulatory process set out in 40 CFR part 702,
subpart B is being followed for the first ten chemical substances
undergoing risk evaluation to the maximum extent practicable.
    Prior to the publication of this final risk evaluation, a draft
risk evaluation was subject to peer review and public comment. EPA
reviewed the report from the peer review committee and public comments
and has amended the risk evaluation in response to these comments as
appropriate. The public comments, peer review report, and EPA's
response to comments is in Docket ID No. EPA-HQ-OPPT-2019-0499. Prior
to the publication of the draft risk evaluation, EPA made available the
scope and problem formulation, and solicited public input on uses and
exposure. EPA's documents and the public comments are in Docket ID No.
EPA-HQ-OPPT-2016-0733. Additionally, information about the scope,
problem formulation, and draft risk evaluation phases of the TSCA risk
evaluation for this chemical is available at EPA's website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-carbon-tetrachloride.

B. What is carbon tetrachloride (CCl4)?

    Carbon tetrachloride (CCl4) is used as a feedstock in
the production of hydrochloro fluorocarbons (HCFCs), hydrofluorocarbons
(HFCs) and hydrofluoroolefins (HFOs), and is a high-production volume
solvent. It is also used as a process agent in the manufacturing of
petrochemicals-derived and agricultural products and other chlorinated
compounds such as chlorinated paraffins, chlorinated rubber and others
that may be used downstream in the formulation of solvents for
degreasing and cleaning, adhesives, sealants, paints, coatings, rubber,
cement and asphalt formulations.

    Authority:  15 U.S.C. 2601 et seq.

Andrew Wheeler,
Administrator.
[FR Doc. 2020-24478 Filed 11-3-20; 8:45 am]
BILLING CODE 6560-50-P