[Federal Register Volume 79, Number 241 (Tuesday, December 16, 2014)]
[Notices]
[Pages 74757-74759]
[FR Doc No: 2014-29431]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2014-0002; Internal Agency Docket No. FEMA-B-1452]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before March 16, 2015.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location and the respective Community Map Repository address listed in
the tables below. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1452, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances

that are more stringent in their floodplain management requirements.
The community may at any time enact stricter requirements of its own or
pursuant to policies established by other Federal, State, or regional
entities. These flood hazard determinations are used to meet the
floodplain management requirements of the NFIP and also are used to
calculate the appropriate flood insurance premium rates for new
buildings built after the FIRM and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location and
the respective Community Map Repository address listed in the tables.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
www.msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: November 24, 2014.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
           Winnebago County, Illinois, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
City of Loves Park.....................  Public Works Department, 100
                                          Heart Boulevard, Loves Park,
                                          IL 61111.
City of Rockford.......................  City Hall, 425 East State
                                          Street, Rockford, IL 61104.
City of South Beloit...................  City Hall, 519 Blackhawk
                                          Boulevard, South Beloit, IL
                                          61080.
Unincorporated Areas of Winnebago        County Courthouse, 404 Elm
 County.                                  Street, Rockford, IL 61101.
Village of Machesney Park..............  Planning & Zoning Department,
                                          300 Roosevelt Road, Machesney
                                          Park, IL 61115.
Village of Pecatonica..................  Village Hall, 405 Main Street,
                                          Pecatonica, IL 61063.
Village of Rockton.....................  Village Hall, 110 East Main
                                          Street, Rockton, IL 61072.
Village of Roscoe......................  Village Hall, 10631 Main
                                          Street, Roscoe, IL 61073.
------------------------------------------------------------------------
             Polk County, Minnesota, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
City of Beltrami.......................  514 Polk Avenue, Beltrami, MN
                                          56517.
City of Climax.........................  Climax City Hall, 102 West
                                          Broadway Street, Climax, MN
                                          56523.
City of Crookston......................  Crookston City Hall, 124 North
                                          Broadway, Crookston, MN 56716.
City of East Grand Forks...............  East Grand Forks City Hall, 600
                                          DeMers Avenue, East Grand
                                          Forks, MN 56721.
City of Fertile........................  Fertile City Hall, 101 South
                                          Mill Street, Fertile, MN
                                          56540.
City of Fisher.........................  Fisher City Office, 313 Park
                                          Avenue, Suite 111, Fisher, MN
                                          56723.
City of Fosston........................  Fosston City Hall, 220 East
                                          First Street, Fosston, MN
                                          56542.
City of Mcintosh.......................  McIntosh City Hall, 115
                                          Broadway, Northwest, McIntosh,
                                          MN 56556.
City of Mentor.........................  Mentor City Hall, 202 Garfield
                                          Avenue, North Mentor, MN
                                          56736.
City of Nielsville.....................  Nielsville City Hall, 36943
                                          440th Street, Southwest,
                                          Nielsville, MN 56568.
City of Winger.........................  Winger City Hall, 10 East
                                          Minnesota Avenue, Winger, MN
                                          56592.
Unincorporated Areas of Polk County....  Polk County Government Center,
                                          612 North Broadway, Room 225,
                                          Crookston, MN 56716.
------------------------------------------------------------------------
               Summit County, Ohio, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
City of Munroe Falls...................  City Hall, 43 Munroe Falls
                                          Avenue, Munroe Falls, OH
                                          44262.
City of Stow...........................  Engineering Department, 3760
                                          Darrow Road, Stow, OH 44224.
------------------------------------------------------------------------
               Warren County, Ohio, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
City of Carlisle.......................  City Hall, 760 West Central
                                          Avenue, Carlisle, OH 45005.
City of Franklin.......................  City Building, 1 Benjamin
                                          Franklin Way, Franklin, OH
                                          45005.
Unincorporated Areas of Warren County..  Administration Building, 406
                                          Justice Drive, Room 167,
                                          Lebanon, OH 45036.
------------------------------------------------------------------------

[FR Doc. 2014-29431 Filed 12-15-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: September 28, 2005 (Volume 70, Number 187)]
[Notices]
[Page 56676-56677]
[DOCID:fr28se05-113]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

September 19, 2005.
    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER02-2330-038.
    Applicants: ISO New England, Inc.
    Description: ISO New England, Inc submits its Twelfth Quarterly
Status Report concerning implementation of the proposed Standard Market
design.
    Filed Date: 09/12/2005.
    Accession Number: 20050915-0007.
    Comment Date: 5 p.m. eastern time on Monday, October 03, 2005.

    Docket Numbers: ER05-1221-001.
    Applicants: Commonwealth Edison Company.
    Description: Commonwealth Edison Co. requests that FERC defer its
consideration of the 7/15/05 Transmission Interconnection Agreement
filing pending the refiling of the agreement with PJM Interconnection's
signature.
    Filed Date: 09/12/2005.
    Accession Number: 20050914-0084.
    Comment Date: 5 p.m. eastern time on Monday, October 03, 2005.

    Docket Numbers: ER04-1252-003.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
files proposed revisions to the Midwest ISO's Open Access Transmission
& Energy Market Tariff, Third Revised Volume No. 1.
    Filed Date: 09/12/2005.
    Accession Number: 20050913-0139.
    Comment Date: 5 p.m. eastern time on Monday, October 03, 2005.

    Docket Numbers: ER05-1265-002.
    Applicants: MidAmerican Energy Company.
    Description: MidAmerican Energy Co. provides additional
clarification regarding the reasons for making the amendments to
MidAmerican Rate Schedule No. 19.
    Filed Date: 09/09/2005.
    Accession Number: 20050913-0142.
    Comment Date: 5 p.m. eastern time on Friday, September 30, 2005.

    Docket Numbers: ER05-1282-001.
    Applicants: Storm Lake Power Partners I, LLC.
    Description: Storm Lake Power Partners I, LLC submits an amendment
to its pending market-based rate schedule submittal to make correction
to its proposed tariff, by replacing its Rate Schedule FERC No. 1 with
original Volume No. 1.
    Filed Date: 09/12/2005.
    Accession Number: 20050914-0089.
    Comment Date: 5 p.m. eastern time on Monday, October 03, 2005.

    Docket Numbers: ER05-1460-000.
    Applicants: Mitchell Electric Membership Corporation.
    Description: Mitchell Electric Membership Corp. advises that due to
amendments to section 201(f) of the Federal Power Act, it is no longer
a public utility.
    Filed Date: 09/08/2005.
    Accession Number: 20050913-0009.
    Comment Date: 5 p.m. eastern time on Thursday, September 29, 2005.

    Docket Numbers: ER05-1474-000.
    Applicants: PJM Interconnection L.L.C.
    Description: PJM Interconnection, LLC submits an executed
interconnection service agreement among PJM, Lancaster Wind Farm, LLC &
Commonwealth Edison Co.
    Filed Date: 09/12/2005.
    Accession Number: 20050913-0133.
    Comment Date: 5 p.m. eastern time on Monday, October 03, 2005.

    Docket Numbers: ER05-1475-000.
    Applicants: Midwest Independent Transmission System Operator.
    Description: Midwest Independent Transmission System Operator, Inc.
submits proposed revisions to the Midwest ISO's Open Access
Transmission & Energy Markets Tariff, Third Revised Volume No.1.
    Filed Date: 09/12/2005.
    Accession Number: 20050913-0132.
    Comment Date: 5 p.m. eastern time on Monday, October 03, 2005.

    Docket Numbers: ER05-1477-000.
    Applicants: Access Energy Cooperative.
    Description: Access Energy Cooperative advises that due to
amendments to section 201(f) of the Federal Power Act, it is no longer
a public utility.
    Filed Date: 08/18/2005.
    Accession Number: 20050819-0082.
    Comment Date: 5 p.m. eastern time on Thursday, September 29, 2005.

    Docket Numbers: ER05-1478-000.
    Applicants: North Central Missouri Electric Cooperative, Inc.
    Description: North Central Missouri Electric Cooperative, Inc.
advises that

due to amendments to section 201(f) of the Federal Power Act, it is no
longer a public utility.
    Filed Date: 08/18/2005.
    Accession Number: 20050819-0083.
    Comment Date: 5 p.m. eastern time on Thursday, September 29, 2005.

    Docket Numbers: ER05-1479-000.
    Applicants: Florida Keys Electric Cooperative Association, Inc.
    Description: Florida Keys Electric Cooperative Association, Inc.
advises that due to amendments to section 201(f) of the Federal Power
Act, it is no longer a public utility.
    Filed Date: 08/18/2005.
    Accession Number: 20050819-0084.
    Comment Date: 5 p.m. eastern time on Thursday, September 29, 2005.

    Docket Numbers: ER05-795-002.
    Applicants: ISO New England, Inc., and New England Power Pool.
    Description: ISO New England, Inc. and New England Power Pool
(NEPOOL) Participants Committee jointly submit a compliance filing
relating to modifications to Phase I of the Ancillary Services Market
Project.
    Filed Date: 09/12/2005.
    Accession Number: 20050914-0083.
    Comment Date: 5 p.m. eastern time on Monday, October 03, 2005.

    Docket Numbers: ER05-980-002.
    Applicants: American Transmission Systems, Incorporated.
    Description: American Transmission Systems Incorporated submits an
amended construction agreement to establish a new 138 kV delivery point
with Buckeye Power Inc. and Holmes-Wayne Electric Coop. dated 2/28/05.
    Filed Date: 09/12/2005.
    Accession Number: 20050913-0140.
    Comment Date: 5 p.m. eastern time on Monday, October 03, 2005.

    Docket Numbers: ER05-989-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits the Amendatory
Agreement No. 4 to the Municipal Participation Agreement between Kansas
City Power & Light Co and the City of Garnett, Kansas.
    Filed Date: 09/12/2005.
    Accession Number: 20050915-0006.
    Comment Date: 5 p.m. eastern time on Monday, October 03, 2005.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and Sec.
385.214) on or before 5 p.m. eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-5242 Filed 9-27-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 37 (Monday, February 25, 2019)]
[Notices]
[Page 6000]
[FR Doc No: 2019-03145]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 4644-015]

Stevens & Thompson Paper Company, Inc., GR Catalyst Two, LLC;
Notice of Application for Transfer of License and Soliciting Comments,
Motions To Intervene, and Protests

    On January 7, 2019, Stevens & Thompson Paper Company, Inc.
(transferor) and GR Catalyst Two, LLC (transferee) filed an application
for the transfer of license of the Dahowa Project No. 4644. The project
is located on the Batten Kill River in Washington County, New York.
    The applicants seek Commission approval to transfer the license for
the Dahowa Project from the transferor to the transferee.
    Applicants Contact: For transferor: Stevens & Thompson Paper
Company, Inc., Attn: Emory L. Waldrip II, President, 27711 Marina
Pointe Drive, Bonita Springs, Florida 34134, Email:
<EMAIL_ADDRESS>    For transferee: GR Catalyst Two, LLC, c/o Gravity Renewables, Inc.,
Attn: Mark J. Boumansour, COO, 1401 Walnut Street, Suite 420, Boulder,
Colorado 80302, Email<EMAIL_ADDRESS>    FERC Contact: Anumzziatta Purchiaroni,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, and protests:
30 days from the date that the Commission issues this notice. The
Commission strongly encourages electronic filing. Please file comments,
motions to intervene, and protests using the Commission's eFiling
system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE, Washington, DC 20426. The first page of any filing should
include docket number P-4644-015.

    Dated: February 15, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-03145 Filed 2-22-19; 8:45 am]
 BILLING CODE 6717-01-P


 [Federal Register: August 26, 2008 (Volume 73, Number 166)] [ Notices]                [Page 50390-50391] [DOCID:fr26au08-108]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58399; File No. SR-NYSEArca-2008-88]

  Self-Regulatory Organizations; Notice of Filing and Immediate

Effectiveness of Rule Change by NYSE Arca, Inc. To Eliminate the

Requirement That Orders Sent Via the InterMarket Linkage System and

Broker Dealer Orders Receive the Same Billing Treatment

August 20, 2008.

    Pursuant to section 19(b)(1) \1\ of the Securities Exchange Act of

1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby

given that, on August 13, 2008, NYSE Arca, Inc. (``NYSE Arca'' or the

``Exchange'') filed with the Securities and Exchange Commission (the

``Commission'') the proposed rule change as described in Items I, II,

and III below, which Items have been prepared by the self-regulatory

organization. The Commission is publishing this notice to solicit

comments on the proposed rule change from interested persons.

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

    \1\ 15 U.S.C. 78s(b)(1).

    \2\ 15 U.S.C. 78a.

    \3\ 17 CFR 240.19b-4.

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

I. Self-Regulatory Organization's Statement of the Terms of Substance

of the Proposed Rule Change

    The Exchange proposes to revise certain requirements pertaining to

Broker Dealer Transaction Fees.

II. Self-Regulatory Organization's Statement of the Purpose of, and

Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization

included statements concerning the purpose of, and basis for, the

proposed rule change and discussed any comments it received on the

proposed rule change. The text of those statements may be examined at

the places specified in Item IV below. The Exchange has prepared

summaries, set forth in sections A, B, and C below, of the most

significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the

Statutory Basis for, the Proposed Rule Change

1. Purpose

    Presently, executions on NYSE Arca resulting from Linkage Orders

are subject to the same billing treatment as other Broker Dealer

orders. Assessing the same fees for both Broker Dealer orders sent

directly to the Exchange and Linkage Orders stems from prior approval

orders that established the pilot program for Linkage Fees.\4\ The

Exchange proposes to eliminate this requirement that Linkage Orders and

Broker Dealer orders receive the same billing treatment. In doing so,

the Exchange will have greater flexibility in designing and

implementing fees within its Post/Take pricing model. By this filing,

the Exchange is not otherwise amending or revising its schedule of

fees. Any future amendment to the Exchange's schedule of fees will be,

of course, subject to a filing with the Commission.\5\

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

    \4\ See Securities Exchange Act Release No. 47560 (March 21,

2003), 68 FR 15257 (March 28, 2003) (notice of filing of SR-PCX-

2003-08). As approved by the Commission, the Exchange's proposal to

establish a pilot program for Linkage Fees noted that executions

resulting from linkage orders will be subject to the same billing

treatment as other broker-dealer executions. See Securities Exchange

Act Release Nos. 47786 (May 2, 2003), 68 FR 24779 (May 8, 2003)

(order approving proposal in SR-PCX-2003-08 to establish pilot

program for Linkage Fees); 56133 (July 25, 2008 [sic]), 72 FR 42210

(August 1, 2007) (SR-NYSEArca-2007-66) (order approving extension of

Linkage Fee pilot program through July 31, 2008); 58056 (June 30,

2008), 73 FR 38482 (July 7, 2008) (SR-NYSEArca-2008-67) (order

approving extension of Linkage Fee pilot program through July 31,

2009).

    \5\ While changes to the Exchange's schedule of fees that apply

to Exchange members may be submitted pursuant to section 19(b)(3)(A)

of the Act and subparagraph (f)(2) of Rule 19b-4 thereunder,

proposed changes that involve the pilot program for Linkage Fees

must be submitted pursuant to section 19(b)(2) of the Act.

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

2. Statutory Basis

    The Exchange believes that the proposed rule change is consistent

with the provisions of Section 6 of the Act,\6\ in general, and Section

6(b)(4) of the Act,\7\ in particular, in that it is designed to provide

for the equitable allocation of reasonable dues, fees, and other

charges among its members and other persons using its facilities.

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

    \6\ 15 U.S.C. 78f(b).

    \7\ 15 U.S.C. 78f(b)(4).

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

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will

impose

any burden on competition that is not necessary or appropriate in

furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed

Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the

proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for

Commission Action

    The foregoing rule change is effective upon filing pursuant to

section 19(b)(3)(A) \8\ of the Act and subparagraph (f)(2) of Rule 19b-

4 \9\ thereunder, because it pertains to a due, fee, or other charge

imposed by NYSE Arca.

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

    \8\ 15 U.S.C. 78s(b)(3)(A).

    \9\ 17 CFR 240.19b-4(f)(2).

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

    At any time within 60 days of the filing of the proposed rule

change, the Commission may summarily abrogate such rule change if it

appears to the Commission that such action is necessary or appropriate

in the public interest, for the protection of investors, or otherwise

in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and

arguments concerning the foregoing, including whether the proposed rule

change is consistent with the Act. Comments may be submitted by any of

the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://

www.sec.gov/rules/sro.shtml); or

     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NYSEArca-2008-88 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities

and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

    All submissions should refer to File Number SR-NYSEArca-2008-88.

This file number should be included on the subject line if e-mail is

used. To help the Commission process and review your comments more

efficiently, please use only one method. The Commission will post all

comments on the Commission's Internet Web site (http://www.sec.gov/

rules/sro.shtml). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that

are filed with the Commission, and all written communications relating

to the proposed rule change between the Commission and any person,

other than those that may be withheld from the public in accordance

with the provisions of 5 U.S.C. 552, will be available for inspection

and copying in the Commission's Public Reference Room, 100 F Street,

NE., Washington, DC 20549, on official business days between the hours

of 10 a.m. and 3 p.m. Copies of the filing will also be available for

inspection and copying at the principal office of the self-regulatory

organization. All comments received will be posted without change; the

Commission does not edit personal identifying information from

submissions. You should submit only information that you wish to make

available publicly. All submissions should refer to File Number SR-

NYSEArca-2008-88 and should be submitted on or before September 16,

2008.

    For the Commission, by the Division of Trading and Markets,

pursuant to delegated authority.\10\

Florence E. Harmon,

Acting Secretary.

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

    \10\ 17 CFR 200.30-3(a)(12).

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

[FR Doc. E8-19786 Filed 8-25-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: March 30, 2006 (Volume 71, Number 61)]
[Notices]
[Page 16151-16152]
[DOCID:fr30mr06-66]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application for Non-Project Use of Project Lands and
Waters and Soliciting Comments, Motions To Intervene, and Protests

March 24, 2006.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Non-Project Use of Project Lands and Waters.
    b. Project No: 271-088 (Notice Re-Issuance).
    c. Date filed: February 9, 2006.
    d. Applicant: Entergy Arkansas, Inc.
    e. Name of Project: Carpenter-Remmel Project.
    f. Location: The project is located on the Quachita River in Hot
Springs and Garland Counties, Arkansas.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r)
and Sec. Sec.  799 and 801.
    h. Applicant Contact: Blake Hogue, 141 West County Line Rd.,
Malvern, AR 72104,<PHONE_NUMBER>.

    i. FERC Contact: Rebecca Martin at<PHONE_NUMBER>, or e-mail
<EMAIL_ADDRESS>
    j. Deadline for filing comments and or motions: April 24, 2006.
    All documents (original and eight copies) should be filed with:
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Please include the project
number (P-271-088 or P-271-089) on any comments or motions filed.
Comments, protests, and interventions may be filed electronically via
the internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the
instructions on the Commission's Web site under the ``e-Filing'' link.
The Commission strongly encourages e-filings.
    k. Description of Application: This is a reissue of a public notice
issued March 1, 2006. The licensee requests Commission approval of a
permit application, filed by Lincoln Street Partners, to build 18
stationary boat slips attached to a new boardwalk to be built on
pilings along the shoreline and a 15 foot by 25 foot enlargement of an
existing boat ramp on Lake Hamilton for the Bayshore Estates
Subdivision. Construction may require the dredging of 8 cubic yards of
material.
    l. Location of Application: The filing is available for review at
the Commission in the Public Reference Room, located at 888 First
Street, NE., Room 2A, Washington, DC 20426, or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``e-Library''

link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, please
contact FERC Online support at<EMAIL_ADDRESS>or toll free
(866) 208-3676 or TTY, contact<PHONE_NUMBER>.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as
applicable, and the Project Number of the particular application to
which the filing refers. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov

under the ``e-Filing'' link.

Magalie R. Salas,
Secretary.
[FR Doc. E6-4650 Filed 3-29-06; 8:45 am]

BILLING CODE 6717-01-P


     EPA Questions and Quality RX Returns Answers for Reverse Distributors

General Questions about the Returns Process
   1. Who initiates the return? Does the RD alert the healthcare facility that credit is available for certain pharmaceuticals or do health care facilities periodically go through inventory to return un-needed items?
   	The customer almost always initiates the return.  Most healthcare facilities have a scheduled 	interval for returning creditable merchandise.   For a hospital with over 1,000 acute care beds 	this can be as frequent as every other week.  For a very 	small hospital with less than 20 acute 	care beds this can be as infrequent as twice a year.  For most hospitals and retailers it is usually 	on a quarterly basis.  As a reverse distributor we use a sales and marketing team to remind 	customers that it has been 90 days since we last received their return goods.
   2. Does the RD have reps that go to healthcare facilities to pull and prepare pharmaceuticals for shipment to the RD?  If so, does the rep know which items will/will not receive credit?

Yes, some clients request this service, which is provided at extra charge.   Our field technicians are trained to exclude obvious wastes like repackaged items, patient labeled medications, and other wastes from certain manufacturers that do not issue credit (e.g. American Regent).  It is not practical from a time on the road perspective to actually have the field tech perform a full returnable analysis outside of our main facility.

   3. Is credit received per container?  Per pill if container has been opened?
	This depends on the manufacturer's published return policy.   Some only issue credit for full 	sealed containers, some for partial containers with certain percentage of content thresholds 	(e.g. must be at least 50% full to receive any credit).  Partial creams, ointments, liquids are not 	ordinarily returnable.
   4. Do healthcare facilities return pharmaceuticals from the patient floors (e.g., drugs that have been re-packaged)? Are re-packaged pharmaceuticals creditable?
	Unless some special billing arrangement has been made between the hospital and/or GPO and 	the manufacturer, no.
   5. Once the shipment arrives at the RD facility, what is the timeframe for processing?
	QRX will open the box and `process' (sort, count, input data into system, produce a report of 	returnable status, and generate packing slips) within 10 business days of receipt.

   6. Are generic brands creditable?
	Larger manufacturers of generics (Teva, Sandoz) usually issue credit for full sealed containers.  	Smaller 	manufacturers (Rugby, Major) frequently do not.
   7. Do expired items typically get credit?
	From a retail environment, 65% of the products are returnable.  For a hospital, it is usually less 	than 50%.  More items a hospital returns are from those aforementioned manufacturers that 	typically do not issue credit, for example on epinephrine syringes on crash carts.  A drug store 	doesn't carry an item like that.
   8. How is the RD paid for its services? Does the RD receive a percentage of the credit?  Is there a flat fee? Are there additional charges to the healthcare facility for waste management?
	We paid for a percentage of either the estimated credit or of the actual credit received 	(customer's choice).  There is sometimes a minimum daily charge for onsite service.  There may 	be additional charges for waste disposal and hazardous waste disposal.
   9. Under what circumstances would a healthcare facility return pharmaceuticals to a (forward) distributor in lieu of sending to a RD?  Do you process pharmaceuticals from (forward) distributors?
	It depends on the state pedigree laws (in Florida, for example, the hospital cannot do what you 	explained above over 30 days after receipt).  This would happen with a product that was 	mistakenly over ordered.  We do not currently process for any wholesaler forward distributors.
   10. When pharmaceuticals are received at the RD, are they ever shipped to another RD's facility for crediting?
	Yes, if there is another reverse distributor contracted to process for that manufacturer as part of 	an outsourcing agreement (like GSK with Stericycle).  Other manufacturers process their own 	returns (like Eli Lilly).
   11. Do you accept non-pharmaceutical products?
	We do not wish to, but sometimes non-pharmaceutical products, ranging from greeting cards to 	panty hose to Christmas decorations to OTC PCPs are sent to us.

   12. How long are pharmaceuticals kept on-site after providing credit?  How long are the pharmaceuticals that become hazardous wastes kept on-site?  On average how long does it take a pharmaceutical to cycle through your facility?
	This depends on the manufacturer's policy and procedure.  If the manufacturer does not require 	an authorization to return, we usually ship out product within five business days after 	determining it has credit value.  If a manufacturer requires a return authorization, and is slow to 	do so, a product could wait months to be returned.
	QRX is an EPA CESQG, but adheres to SQG rules in general and returns hazardous wastes every 	180 days or less.  P-listed wastes are returned when necessary to keep under the 1 kilo 	generator threshold.
	The average product is in our warehouse for 40 days.

Shipment
   1. Are returned pharmaceuticals shipped to the RD via commercial mail carrier or USPS or private hauler?  Is the shipment tracked and is the healthcare facility notified by the RD that the shipment has been received?  Do healthcare facilities notify the RD that a shipment has been sent?
	Common carrier, usually FedEx Ground, hauls QRX product.   For very large returns, an LTL truck 	service is used, as long as the return is palletized.  All shipments are tracked using a daily activity 	report provided by our contracted carrier.  Customer Service/Sales personnel notify the 	customer when the product is received.  Smaller customers typically do not inform us ahead of 	time, and we find out when we check our inbound shipping report from FedEx.
	One major exception to this is when there are DEA controlled substances involved; all parties 	are notified in advance of shipment, especially for DEA Class II drugs (e.g. Oxycontin).
   2. Does the board of pharmacy require RDs to keep an inventory of everything received at an RD?
	While not required by the state of Tennessee, we do so anyway at QRX as part of our internal 	best practice.
   3. Are controlled substances shipped separately from other pharmaceuticals?  Can you explain more about the process of handling returned controlled substances?
	Controlled substances fall into two categories for us, Class II (e.g. Oxycontin, Cocaine, Fentanyl) 	and Class III-V (e.g. Ambien, Xanax, Phentermine).
	To return CII drugs, a DEA 222 form must accompany the shipment.  The customer requests our 	DEA 222 and we send it to them after verifying their request along with a separate shipping 	label that has an internal secret code so when the product is received, our receiving clerks know 	immediately that this is a CII controlled substance and it is locked up in our vault until such time 	that it is processed.   DEA rules require that the returned product and the request match 	absolutely exactly, so precision is key.
	The process for CIII-V is similar but not quite as stringent.  For example, there is an inventory 	form along with a bag to separate the CIII-V from the rest of the drugs in the box.  As soon as the 	box is open, the inventory form we supplied the customer, along with the drugs in question, are 	segregated in our DEA approved security cage.
   4. Have there been incidences where shipments have been lost or stolen?
	Fortunately for QRX, this has never happened to our company.
Waste Determination and Management
   1. What percentage of returned pharmaceuticals is typically RCRA hazardous waste once it is determined credit will or will not be given?  Typically, do pharmaceuticals that meet RCRA's definition of a hazardous waste get credit?  Do you ever manage non-hazardous pharmaceuticals as RCRA hazardous waste?
	Approximately 5% of products returned meet some type of RCRA criteria.  However, only an 	item that is deemed non-returnable will be categorized as RCRA hazardous waste.  While it can 	be defined as off spec or expired, it still holds its original commercial value or a percentage 	thereof.  So the correct way to phrase this is that of the 40% of non-returnable product, 5% of 	that is RCRA.
	Again, in reference to my point above, if it is creditable it is not a `waste'.  However, we 	understand the point of the question being asked, and yes, many items like warfarin sodium 	(P001 when waste), especially brand name Coumadin from Bristol Myers-Squibb, and insulin 	(D009 when waste) from manufacturers like Eli Lilly and Novo Nordisk, do routinely receive 	credit.  However, there are other products like nicotine (P075) that are almost all OTC products 	and are for our purposes never creditable.
	We do not manage items that do not meet RCRA definitions as hazardous.  However, we 	encourage our customers to ensure the following items are incinerated when waste whenever 	possible.  So while we do not manage non hazardous pharmaceuticals as RCRA because all of 	our waste is incinerated anyway, we encourage customer we might be using an autoclave or 	landfill for some of their waste streams to make sure some non-RCRA product is incinerated.  	Not necessarily at a RCRA incinerator, but at an incinerator instead of autoclave or landfill.
                            ITEMS TO BE INCINERATED
   I.                RCRA Acutely Toxic Waste (RCRA INCINERATION)
         a.                      COMMON EXAMPLES- Warfarin Sodium, Nicotine, Physostigmine, Phentermine
   II.                Mixed Infectious Hazardous Waste (RCRA INCINERATION)
         a.                      COMMON EXAMPLES- Crofab Antivenin, Intron Alfa 2B, Live Vaccines with Thimerosal Preservatives, Abraxane
   III.                RCRA Hazardous Pharmaceuticals (RCRA INCINERATION)
         a.                      COMMON EXAMPLES (U-list)  -  Lindane, Mitomycin, Daunorubicin, Cyclophosphamide
         b.                      COMMON EXAMPLES (D-list)  -  Flexible Collodion, Silver Sulfadiazine, Barium Sulfate, Selenium
         c.                      COMMON EXAMPLES (Flammable Gases)  -  Epifoam, Protofoam, Granulex, Ethyl Chloride
   IV.                D.O.T. Non-Flammable Gases require special transport placards and should be segregated for incineration.  Non-Flammable gases may be shipped with flammable gases.
         a.                      COMMON EXAMPLES  -  Ventolin, Maxair, Atrovent
   V.                E.P.A. Categories of Concern are products that may not yet be regulated, but we expect  regulatory action regarding these items.
         a.                      E.P.A. Classified Greenhouse Gas
         b.                      COMMON EXAMPLE  -  Sevoflurane
         c.                      E.P.A. Contaminant Candidate List 3
         d.                      COMMON EXAMPLE  -  Estradiol
         e.                      E.P.A. Regulated Pesticide
         f.                      COMMON EXAMPLE  -  Permethrin
   VI.                Joint Commission Hazardous- The Joint Commission, the National Institute for Occupational Safety and Health (NIOSH), and the Occupational Safety and Health Administration (OSHA) urge hospitals to prioritize safety and health protocols for the most hazardous drugs.  This category is a now combined entry of items found in the OSHA Technical Manual, Section VI, Chapter 2 listed drugs, NIOSH "Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings 2004", and the NIOSH "List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010",  from the Joint Commission Online, April 13, 2011.
   1. Is the manufacturer always contacted prior to disposal of a creditable pharmaceutical? For a non-creditable pharmaceutical?
	Yes, we always notify the manufacturer prior to destroying a creditable pharmaceutical; 	otherwise they might deny us and our customer our credit due.  If they have already denied 	credit either per policy or authorization, our duty to the manufacturer is complete and we 	destroy without notifying them.
   2. What percentage of returned pharmaceuticals is sent back to the manufacturer versus being disposed of directly by the RD?
	Approximately 60% of our product is returned, and 40% is destroyed.  This can vary from return 	company to return company based on my aforementioned explanation about different 	customer classes having different amounts of returnable product.


[Federal Register Volume 79, Number 94 (Thursday, May 15, 2014)]
[Notices]
[Pages 27875-27877]
[FR Doc No: 2014-11170]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0531]

Hemostatic Medical Devices for Trauma Use; 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 following
public workshop entitled ``Hemostatic Medical Devices for Trauma Use.''
FDA is holding this public workshop to obtain information on the
current challenges and opportunities related to hemostatic medical
devices for use in emergency situations. The goals of the workshop are
to discuss factors that contribute to hemostatic medical device
performance and reliability and types of studies used to assess
bleeding and validate methods to evaluate the severity of bleeding, and
to define regulatory pathways for novel products.
    Dates and Times: The public workshop will be held on September 3
and 4, 2014, 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: Allison Kumar, 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 August 22, 2014, 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, (email<EMAIL_ADDRESS>or phone: 301-
796-5661) no later than August 20, 2014.
    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, email, and telephone number. Those
without Internet access should contact Allison Kumar 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 Wednesday, August 22, 2014. 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 August 26, 2014. 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.)
    Requests for Protocols: In advance of the public workshop, CDRH
would like to invite interested stakeholders to submit protocols that
describe procedures to evaluate issues (e.g., design, validation,
conduct, and analysis) related to the adequacy of studies pertaining to
bench testing, animal testing, bleeding severity, human factors, and
clinical data collection for hemostatic products. Of particular
interest to the Agency are methods for assessing high-risk products
used in non-compressible wound hemorrhage.
    The intention of collecting these protocols is for the Agency to
review the submissions and determine viable solutions and paradigms for
assessing the safety and effectiveness of hemostatic devices based on
scientifically supported expert stakeholder opinions. The result of
such a review will be incorporated into the public workshop for in-
depth discussion and consensus potentially leading to guidance from the
Agency. Please note that while FDA safeguards study protocols and all
proprietary information it receives, the protocols submitted in
response to this request for protocols will be shared and potentially
discussed publically. The deadline for submitting protocols for this
public workshop is June 27, 2014. See the comments section for
information on how to submit protocols. Please note that information
submitted to the docket will be publically available.
    Comments: FDA is holding this public workshop to obtain information
on the current challenges and opportunities related to hemostatic
medical devices for use in emergency situations. In order to permit the
widest possible opportunity to obtain public comment, FDA is soliciting
either electronic or written comments on all aspects of the public
workshop topics. The deadline for submitting comments related to this
public workshop is October 3, 2014.
    Regardless of attendance at the public workshop, interested persons
may submit either electronic comments regarding this document 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. Identify comments with the docket number found in brackets in
the heading of this document. In addition, when responding to specific
questions as outlined in section II of this document, please identify
the question 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

    There exists a large variety of hemostatic products on the market
and in development that are being used for or are intended to be used
to control potentially life-threatening bleeding in emergency
situations when there may be no immediate medical facility nearby. Such
devices may fit into various medical device regulatory categories such
as the absorbable hemostatic agents (21 CFR 878.4490), externally
applied vascular clamps (21 CFR 870.4450), various other class II
devices, unclassified products (proposed for classification into class
II), and those that may be proposed for other regulatory pathways, such
as de novo petitions or PMA applications. There are currently a number
of scientific and clinical challenges faced by industry and FDA that
hamper the evaluation of such products. These include: The difficulty
in measuring severity of bleeding in a consistent, reproducible and/or
standardized manner, the lack of a bleeding severity scale (i.e.,
operationalizing the definition of bleeding severity); the
translatability of animal models to the human clinical environment, the
fact that different products present unique issues, and the challenge
of evaluating innovative products when human clinical data are
difficult to obtain.
    FDA is organizing a hemostatic medical devices public workshop
focused on the current challenges and opportunities with hemostatic
medical devices for use in emergency situations. The participants
include a broad range of stakeholders that are responsible for the
design, testing, manufacturing, regulation, and use of hemostatic
devices. Specifically, the public workshop is intended to foster open
constructive dialogue:
     On the challenges related to the design, development,
evaluation, and use of hemostatic medical devices.
     To facilitate collaboration amongst stakeholders
interested in hemostatic medical device development and use.
     To promote development of regulatory science tools for
evaluating hemostatic medical devices.

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 products used for emergency treatment
of bleeding and the respective Centers, Divisions, and Branches within
FDA involved in their review.
    2. Definitions of bleeding severity and methods for validating
bleeding severity scales used in the evaluation of hemostatic devices.
    3. Pre-clinical studies, including animal studies, that can be used
to collect data when clinical data are difficult to obtain. What value
do these models provide (for the evaluation of hemostatic medical
devices?) and what are their shortcomings?
    4. What options exist for obtaining clinical data for products used
for emergency treatment of bleeding in both Civilian and Military
settings, and which devices should be supported by clinical data?
    5. Products used for emergency treatment of bleeding are often used
by a variety of end users and in a variety of high-stress situations;
improper or unnecessary device use has the potential to cause serious
harm. What human factors issues exist with use of these products and
how should these issues be studied?
    6. Discussion of protocols used to study the topics, such as
validation of bleeding severity, bench-top, animal, and human studies,
and assessment of hemostatic devices used for non-compressible
hemorrhage.
    These topics will be presented by experts in the associated area,
followed by more indepth discussions of the given topics in smaller
breakout sessions.

    Dated: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11170 Filed 5-14-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 2 (Friday, January 3, 2020)]
[Notices]
[Page 310]
[FR Doc No: 2019-28334]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0236; FRL-10003-71]

N-Methylpyrrolidone (NMP); Draft Toxic Substances Control Act
(TSCA) Risk Evaluation; Notice of Availability; Extension of Comment
Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; extension of comment period.

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

SUMMARY: EPA issued a notice in the Federal Register of November 7,
2019, announcing the availability of and soliciting public comment on
the draft Toxic Substances Control Act (TSCA) risk evaluation of N-
Methylpyrrolidone (NMP). This document extends the comment period for 2
weeks, from January 6, 2020 to January 21, 2020.

DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPPT-2019-0236, must be received on or before January 21, 2020.

ADDRESSES: Follow the detailed instructions provided under ADDRESSES in
the Federal Register document of November 7, 2019 (84 FR 60087) (FRL-
10001-87).

FOR FURTHER INFORMATION CONTACT: For technical information contact: Dr.
Stan Barone, 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: This document extends the public comment
period established in the Federal Register document of November 7, 2019
(84 FR 60087) (FRL-10001-87). In that document, EPA announced the
availability of and solicited public comment on the draft Toxic
Substances Control Act (TSCA) risk evaluation of N-Methylpyrrolidone
(NMP). The purpose of the risk evaluation process under TSCA is to
determine, upon issuance of a final risk evaluation, 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. EPA is
hereby extending the comment period in response to several requests for
additional time.
    To submit comments, or access the docket, please follow the
detailed instructions provided under ADDRESSES in the Federal Register
document of November 7, 2019. If you have questions, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

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

    Dated: December 18, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2019-28334 Filed 1-2-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 178 (Monday, September 15, 2014)]
[Proposed Rules]
[Pages 54941-54942]
[FR Doc No: 2014-21572]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2011-0659; FRL-9916-42-Region-8]

Approval and Promulgation of Air Quality Implementation Plans;
Wyoming; Revisions to the Wyoming Air Quality Standards and
Regulations; Ambient Standards for Nitrogen Oxides and for Ozone

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
State of Wyoming. The revision affects Wyoming's Air Quality Standards
and Regulations (WAQSR) regarding ambient standards for nitrogen oxides
(NOX) and for ozone. This action is being taken under
section 110 of the Clean Air Act (CAA).

DATES: Written comments must be received on or before October 15, 2014.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2011-0659, by one of the following methods:

     http://www.regulations.gov. Follow the on-line
instructions for submitting comments.
     E-Mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER> (please alert the individual listed in
the FOR FURTHER INFORMATION CONTACT if you are faxing comments).
     Mail: Director, Air Program, EPA, Region 8, Mailcode 8P-
AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129.
     Hand Delivery: Director, Air Program, EPA, Region 8,
Mailcode 8P-AR, 1595 Wynkoop, Denver, Colorado 80202-1129. Such
deliveries are only accepted Monday through Friday, 8:00 a.m. to 4:30
p.m., excluding Federal holidays. Special arrangements should be made
for deliveries of boxed information.

Please see the direct final rule which is located in the Rules Section
of this Federal Register for detailed instruction on how to submit
comments.

FOR FURTHER INFORMATION CONTACT: Steven Pratt, Air Program, EPA, Region
8, Mailcode 8P-AR, 1595 Wynkoop, Denver, Colorado 80202-1129, (303)
312-6575<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the ``Rules and Regulations'' section of
this Federal Register, EPA is approving Wyoming's SIP revision as a
direct final rule without prior proposal because the Agency views this
as a noncontroversial SIP revision and anticipates no adverse comments.
A detailed rationale for the approval is set forth in the preamble to
the direct final rule. If EPA receives no adverse comments, EPA will
not take further action on this proposed rule. If EPA receives adverse
comments, EPA will withdraw the direct final rule and it will not take
effect. EPA will address all public comments in a subsequent final rule
based on this proposed rule. EPA will not institute a second comment
period on this action. Any parties interested in commenting must do so
at this time. Please note that if EPA receives adverse comments on an
amendment, paragraph, or section of this rule and if that provision may
be severed from the remainder of the rule, EPA may adopt as final those
provisions of the rule that are not the subject of an adverse comment.
See the information provided in the Direct Final action of the same
title which is located in the Rules and Regulations Section of this
Federal Register.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: August 25, 2014.
Debra H. Thomas,
Acting Regional Administrator, Region 8.
[FR Doc. 2014-21572 Filed 9-12-14; 8:45 am]
BILLING CODE 6560-50-P


                           SUPPORTING STATEMENT FOR
RENEWABLE FUELS STANDARD (RFS2) VOLUNTARY RIN QUALITY ASSURANCE PROGRAM (PROPOSED RULE)

A.	JUSTIFICATION

1.	Identification of the Information Collection

a.	Title:  RFS2 Voluntary RIN Quality Assurance Program, EPA ICR No. xxxx.xx, OMB Control Number xxxx-NEW.

b. 	Short characterization:

	The Renewable Fuel Standard (RFS) program began in 2006 pursuant to the requirements in Clean Air Act (CAA) section 211(o) which were added through the Energy Policy Act of 2005 (EPAct).  The statutory requirements for the RFS program were subsequently modified through the Energy Independence and Security Act of 2007 (EISA), resulting in the promulgation of major revisions to the regulatory requirements on March 26, 2010.

	The RFS program requires that specified volumes of renewable fuel be used as transportation fuel, heating oil, and/or jet fuel each year.  To accomplish this, EPA publishes applicable percentage standards annually that apply to the sum of all gasoline and diesel produced or imported.  The percentage standards are set so that if every obligated party meets the percentages, then the amount of renewable fuel, cellulosic biofuel, biomass-based diesel, and advanced biofuel used will meet the volumes required on a nationwide basis.

	Obligated parties demonstrate compliance with the standards through the acquisition of unique Renewable Identification Numbers (RINs) assigned by the producer or importer to every batch of renewable fuel produced or imported.  Validly generated RINs show that a certain volume of qualifying renewable fuel was produced or imported.  The RFS program also includes provisions stipulating the conditions under which RINs are invalid, the liability carried by a party that transfers or uses an invalid RIN, and how invalid RINs must be treated.

	The RIN system within the RFS program contains unique features that make it more challenging for the obligated parties that need RINs for compliance purposes to verify that those RINs have been validly generated.  Several cases of fraudulently generated RINs have compelled some obligated parties to limit their business relationships to only those parties that appear most trustworthy.  This reaction by the obligated parties has made it more difficult for smaller renewable fuel producers to sell their RINs and has reduced the overall liquidity of the RIN market.  In order to ensure that RINs are validly generated, individual obligated parties are now conducting their own audits of renewable fuel production facilities, potentially duplicating one another's efforts.  These circumstances have created inefficiencies in the RIN market, prompting requests for an additional regulatory mechanism that would reduce the risk of potentially invalid RINs, return liquidity to the RIN market, and reduce the cost of verifying the validity of RINs.

	In this action we are proposing a voluntary quality assurance program intended to provide a more structured way to assure that the RINs entering commerce are valid.  The proposed program would also provide an affirmative defense against violations under certain conditions for the transfer or use of invalid RINs, and would specify both the conditions under which invalid RINs must be replaced with valid RINs, and by whom.  The voluntary program would enable smaller renewable fuel producers to demonstrate that their RINs are valid, reducing the risk that obligated parties believe is associated with such RINs.

	The voluntary quality assurance program for RINs would provide a means for regulated parties to ensure that RINs are properly generated, through audits of production facilities conducted by independent third parties using quality assurance plans (QAPs).  To this end, we are proposing the following:

      ::	Minimum requirements for QAPs, including such things as verification of type of feedstocks, verification that volumes produced are consistent with amount of feedstocks processed, and verification that RINs generated are appropriately categorized and match the volumes produced

      ::	Qualifications for independent third-party auditors

      ::	Financial instruments that would provide assurance than invalid RINs are replaced with valid RINs

      ::	Requirements for audits of renewable fuel production facilities, including minimum frequency, site visits, review of records, and reporting

      ::	Changes to EMTS that would accommodate the quality assurance program

	We are proposing a number of options that would be available to regulated parties seeking to verify that RINs are validly generated.  These options would provide flexibility in how parties choose to balance the risk of transferring or using invalid RINs and costs.  We believe that the costs associated with this voluntary quality assurance program are warranted to ensure the viability of the renewable fuel and RIN markets.  This cost assessment includes the cost of performing audits, to both the fuel producer and the auditor, the added costs of the financial instruments which some RIN producers and verifiers may choose, and the cost to the Agency in implementing this program.

	There are approximately 485 biofuel producers operating more than 600 biofuel production facilities.  These numbers are expected to increase as the biofuel market expands.  While it is unlikely that all biofuel producers will opt to implement a QAP, that was the assumption for these cost estimates in order to reflect the maximum potential cost of the program.

2.  Need For, and Use of, the Collection

      a. Authority for the Collection

	Sections 114 and 208 of the Clean Air Act (CAA), 42 U.S.C. §§ 7414 and 7542, authorize EPA to require recordkeeping and reporting regarding enforcement of the provisions of Title II of the CAA.

	b. 	Practical Utility/Uses of the Data

	The recordkeeping and reporting requirements of this regulation will allow EPA to monitor compliance with the RFS program.  	The quality assurance program would help to ensure that the RIN system operates as originally intended.  The primary impacts of the quality assurance program would be improved liquidity in the RIN market and improved opportunities for smaller renewable fuel producers to sell their RINs.  The data generated by the QAP program will assist obligated parties and smaller renewable fuel producers comply with the requirements of the RFS program by supporting the validity of RINs.

	The quality assurance program that we are proposing would be voluntary.  As a result, there would be no obligatory costs.  There would be costs associated with an individual party's participation in the quality assurance program, and in Section XX we have provided estimates of the costs of participation.  These estimates are supported by data provided by several potential QAP vendors.  It is worthwhile to note that, as this is a voluntary program intended to support a current market system, any costs incurred would only be borne if the industry believed that those costs were less than current costs in the marketplace resulting from efforts to verify, acquire, and trade RINs.

3.  Non-duplication, Consultation, and other Collection Criteria

	a. 	Non-duplication

	Efforts have been made to eliminate duplication in this information collection. The QAP may substitute for data previously required in RFS data collection and reporting regulations.

      b. 	Public Notice

	We are describing the proposed recordkeeping and reporting in the notice of proposed rulemaking and are providing this draft supporting statement in order to assist parties potentially affected by RFS2 Voluntary Quality Assurance Program to comment upon recordkeeping and reporting burdens.

	c. 	Consultations

	We have met with seven (7) parties who are already developing RIN validation programs for the biofuels industry.  We have also met with several industry groups and obligated parties which have been affected by RIN fraud.  These parties all provided informal estimates of the costs associated with this type of quality assurance program which was used to inform the cost calculations made for this statement.

	d. 	Effects of Less Frequent Data Collection

	We have designed the reporting schedule to coincide with existing reporting deadlines applicable to many of the same parties under such programs as RFG and anti-dumping and diesel fuel.  Because this is a quality assurance program, more frequent data collection is more likely to ensure the validity of the RINs audited.  The program is structured to allow the market to balance the benefits of the program with the costs.  Less frequent collection of data would jeopardize the validity of audited RINs and would negatively impact the entire RIN market.

	e. 	General Guidelines

	All Office of Management and Budget (OMB) guidelines are met.

	f. 	Confidentiality

	We inform respondents that they may assert claims of business confidentiality (CBI) for information they submit. We have proposed that actual RINs should not be treated as confidential business information under RFS2, as they are necessary identifiers to accompany renewable fuels.  In order to ensure transparency in the RIN validation program, as much of the associated data as possible should be made publicly accessible.  Any information claimed as confidential will be treated in accordance with 40 CFR Part 2 and established Agency procedures.  Information that is received without a claim of confidentiality may be made available to the public without further notice to the submitter under 40 CFR § 2.203.

      g. 	Sensitive Information

	This information collection does not require submission of any sensitive information.

4.	The Respondents and the Information Requested

	a.	Respondents/with NAICS and SIC Codes

The respondents to this information collection fall into the following general industry categories:  petroleum refineries (324110/2911), ethyl alcohol manufacturers (325193/2869), other basic organic chemical manufacturing (325110/2869), chemical and allied products merchant wholesalers (426990/5169), petroleum bulk stations and terminals (422710/5171), petroleum and petroleum products merchant wholesalers (422720/5172), and other fuel dealers (454319/5989).

	b.	Information Requested

	For those biofuel producers who opt into the QAP, each biofuel production facility must be visited and assessed as part of any audit conducted under the proposed quality assurance program.  An auditor would use an approved QAP as the basis for the verification of biofuel produced and RINs generated at a facility.  In order to verify production, the auditor must conduct site visits, review documents, and contact entities that do business with the facility.  The proposed components of audits are discussed below.

	Elements of a QAP Audit:

         * Physical Examination of Facility and Operations

      The goal of the onsite visit is to verify that plant has the technology to produce, store, and blend biofuels at registered levels.  The auditor will likely use plant maps and photos as part of this analysis, and should compare and contrast the plant's infrastructure with the third party engineering review reports on file with EPA.  The auditor should note the size and number of storage and blending tanks, and observe the measurement of volume in the tanks.  The auditor should determine whether the process rate is consistent with annual production of the facility, and whether the facility has quality process controls in place.

      We believe that mass and energy balances on the facility are critical components of any audit.   Because integrated facilities will likely have energy usage that is not directly related to biofuel production, the auditor should have alternate means of assessing and correlating energy usage to production.

         * Document Review

      The auditor should ensure that the producer has and is fulfilling the EPA record-keeping requirements at §80.1454(c)(1)(i)(A)-(B) and (ii).  We expect the auditor to evaluate reports submitted to EPA, and propose that these be reports year-to-date, as applicable, and from the previous year, for comparison.  These include Activity Reports, RIN transaction reports, RIN generation reports, and Renewable Fuel producer Co-product reports.  The third-party engineering review and annual attestation report should also be reviewed.

      Reports submitted to EPA should be cross-checked with other records.  For instance, the auditor should have access to certificates of analysis for all batches of feedstocks.  The auditor might consider spot-checking recent feedstock receipts (if the producer uses a variety of feedstocks, then the auditor should be provided with receipts for each feedstock).  Integrated facilities may not have internal sales receipts for feedstock usage, so an alternative paper trail will likely be required.  Similar to the feedstock document review and crosscheck, renewable fuel and co-product delivery documentation should be part of any audit.

         * Review and Reporting

      We expect the auditor to contact the biofuel producer's customers and suppliers in order to verify sales and purchases.  This will likely require ongoing monitoring of the biofuel production facilities by auditor staff or consultants.  In addition, auditors are likely to need to track RINs on EMTS.  This will ensure that the verified RINs are being reported accurately.  Auditors will be responsible for preparing the QAP and submitting it to EPA.

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

a.	Agency Activities

*          Respond to inquiries on QAP requirements and options
*          Provide copies of the regulations
*          Acknowledge receipt of qualifying QAPs
*          Assist EMTS users with new functions in system related to QAPs
*          Refer violations to enforcement personnel
*          Contact reporting parties if there is a problem with their submission

b. 	Collection and Methodology and Management

	We anticipate receiving data in a simplified and secure fashion via the Agency's CDX.  Information claimed as CBI will be stored in appropriately controlled areas.  Auditors will collect data in a wide variety of ways, as is appropriate to the specific production facility, as indicated in the Information Collected section above.  Many of the auditors consulted plan to use electronic, remote sensing, and web-based systems to make data collection as efficient as possible.

c.	Small Entity Flexibility

	This collection will not adversely affect small entities.  The notice of proposed rulemaking describes flexible provisions available to small entities.  This program was specifically designed with the small biofuel producer in mind, as they have been the most negatively impacted by the RIN fraud to date.

d.	Collection Schedule

	We are proposing that an auditor conduct at least four (4) onsite visits per year, or every three (3) months.  We are proposing that new production facilities should be audited before startup and, subsequently, according to the standard quarterly schedule. We expect that each visit could take from one to several days, depending on the size and complexity of the facility, the availability of records, changes since the last audit, etc.  For some components of the audit we propose to require real-time, or batch-level monitoring.  The QAP would be required to provide details of the means for collection and evaluation of the data collected in real-time.

6.	Estimating the Burden and Cost of Collection

      a.	Estimating the Respondent Universe

	We based our estimated respondent numbers on the number of registered biofuel producers and facilities in EMTS.  In order to estimate the maximum cost of this data collection request, we assumed that all parties would opt to use the QAP.  It is highly unlikely that all biofuel producers will make this choice, and therefore the costs will in reality to be lower than those estimated here.  Note that the costs are expected to be linear; i.e. there are no economies of scale assumed, based on the number of respondents.

      b.	Estimating the Respondent Burden and Cost

	Three labor categories are involved:  managerial, technical/professional, and clerical. The estimates use the Bureau of Labor Statistics mean average wages for relevant employee categories (May 2011).  The following wages and benefits apply by category:

Wages and Benefits

Managerial 		$55.04 per hour
Technical		$47.81 per hour
Clerical		$18.35 per hour

Doubling for company overhead beyond wages and benefits, and for convenience, rounding up to the dollar, gives the following rates for this ICR:

Total Employer Cost

Managerial		$110 per hour
Technical		$96 per hour
Clerical		$37 per hour

We have estimated the amount of time needed for each labor category, and for each expected step in the QAP development process.  These time estimates are shown in the attached Excel spreadsheet.

	c.	Estimating the Agency Burden and Cost

	EPA must check each QAP submission for completeness.  EPA will be reviewing the qualifications of the QAP providers. Reporting parties must be contacted if there is a problem with their submission.  It is anticipated that the QAP will require minimal additional burden and cost on EPA, relatively to the effort already undertaken for previous RFS reporting requirements.

	This supporting statement considers costs associated with accepting QAP submissions. We anticipate that each QAP will require just 2 hours of review by one full time GS-13 technical employee at a current pay rate of $44.65 per hour.  Doubled to account for overhead and benefits, the hourly agency burden is estimated at $89.   These costs are included in Excel spreadsheet.

d.	Estimating the Respondent Universe

	We were able to estimate the number of regulated entities drawing upon experience regulating the same or similar entities.  The maximum number of respondents for this program was estimated using the current number of producers registered in EMTS.  It is unlikely that all biofuel producers will choose to utilize the QAP, in which case the number of respondents would be less then the number assumed here.

e.	Bottom Line Burden Hours and Costs

	We estimate the following totals:

	TOTAL NO. OF RESPONDENTS:  	 485
	TOTAL BURDEN HOURS:    		 194,670
	TOTAL COST TO RESPONDENTS:  	 $ 4,062,000

f.	Reason for Change in Burden

	The change in burden is due to proposed regulations that allow additional RFS reporting.

g.	Burden Statement

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

 	To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID number EPA-HQ-OAR-2005-0161, which is available for online viewing at www.regulations.gov, or in person viewing at the Air Docket in the EPA Docket Center in Washington, DC (EPA/DC).  The docket is located in the EPA West Building, 1301 Constitution Avenue, NW, Room 3334, and is open from 8:30 a.m. to 4:30 p.m., Eastern Standard Time, Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Air Docket is<PHONE_NUMBER>.

 	You may use www.regulations.gov to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically.  When in the system, select "search," then key in the Docket ID Number EPA-HQ-OAR-2005-0161.  Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include the EPA Docket ID Number EPA-HQ-OAR-2005-0161 and OMB Control Number 2060-NEW in any correspondence.


[Federal Register Volume 88, Number 98 (Monday, May 22, 2023)]
[Notices]
[Pages 32767-32768]
[FR Doc No: 2023-10823]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0067; FRL-10578-03-OCSPP]

Pesticide Product Registration; Receipt of Applications for New
Uses (March 2023)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has received applications to register new uses for
pesticide products containing currently registered active ingredients.
Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), EPA is hereby providing notice of receipt and opportunity to
comment on these applications.

DATES: Comments must be received on or before June 21, 2023.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0067, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Dan Rosenblatt, Registration Division
(RD)

(7505T), main telephone number:<PHONE_NUMBER>, email address:
[email protected]. The mailing address for this contact person is
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001. As part of the mailing
address, include the contact person's name, division, and mail code.
The division to contact is listed at the end of each application
summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Registration Applications

    EPA has received applications to register new uses for pesticide
products containing currently registered active ingredients. Pursuant
to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA
is hereby providing notice of receipt and opportunity to comment on
these applications. Notice of receipt of these applications does not
imply a decision by the Agency on these applications.

Notice of Receipt--New Uses

    1. EPA Registration Numbers:100-759, 100-953, and petition #2E9007.
Docket ID number: EPA-HQ-OPP-2022-0644. Applicant: The IR-4 Project, NC
State University, Campus Box 7710, Raleigh, NC, 27695. Active
ingredient: Fludioxonil. Product type: Fungicide. Proposed Use:
Additional new food uses of fludioxonil on cranberry. Contact: RD.
    2. EPA Registration Numbers: 100-811, 100-953, and petition
#2E9006. Docket ID number: EPA-HQ-OPP-2022-0645. Applicant: The IR-4
Project, NC State University, Campus Box 7710, Raleigh, NC, 27695.
Active ingredient: Cyprodinil. Product type: Fungicide. Proposed Use:
Additional new food uses of cyprodinil on cranberry. Contact: RD.
    3. EPA Registration Numbers: 8033-140, 8033-139. Docket ID number:
EPA-HQ-OPP-2022-0742. Applicant: Nippon Soda Co., Ltd c/o Nisso America
Inc. 379 Thornall Street, 5th floor Edison, NJ 08837. Active
ingredient: Ipflufenoquin. Product type: Fungicide. Proposed Uses:
Fruit, small, vine climbing except fuzzy kiwifruit (crop sub-group 13-
07F), stone fruit (crop group 12-12), and tree nuts (crop group 14-12).
Contact: RD.
    Authority: 7 U.S.C. 136 et seq.

    Dated: May 15, 2023.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Program Support.
[FR Doc. 2023-10823 Filed 5-19-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Notices]
[Pages 70181-70182]
[FR Doc No: 2020-24422]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0487]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Clearance for
the Collection of Qualitative Feedback on Agency Service Delivery

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by December 4, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0697. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Generic Clearance for the Collection of Qualitative Feedback on Agency
Service Delivery

OMB Control Number 0910-0697--Extension

    The information collection activity will garner qualitative
customer and stakeholder feedback in an efficient, timely manner, in
accordance with the Administration's commitment to improving service
delivery. By qualitative feedback we mean information that provides
useful insights on perceptions and opinions but are not statistical
surveys that yield quantitative results that can be generalized to the
population of study. This feedback will provide insights into customer
or stakeholder perceptions, experiences and expectations, provide an
early warning of issues with service, or focus attention on areas where
communication, training or changes in operations might improve delivery
of products or services. These collections will allow for ongoing,
collaborative, and actionable communications between the Agency and its
customers and stakeholders. It will also allow feedback to contribute
directly to the improvement of program management.
    Feedback collected under this generic clearance will provide useful
information, but it will not yield data that can be generalized to the
overall population. This type of generic clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance. Such
data uses require more rigorous designs that address the following: The
target population to which generalizations will be made, the sampling
frame, the sample design (including stratification and clustering), the
precision requirements or power calculations that justify the proposed
sample size, the expected response rate, methods for assessing
potential non-response bias, the protocols for data collection, and any
testing procedures that were or will be undertaken prior to fielding
the study. Depending on the degree of influence the results are likely
to have, such collections may still be eligible for submission for
other generic mechanisms that are designed to yield quantitative
results.
    Respondents to this collection of information cover a broad range
of stakeholders who have specific characteristics related to certain
products or services regulated by FDA. These stakeholders include
members of the general public, healthcare professionals, the industry,
and other stakeholders who are related to a product under FDA's
jurisdiction.
    In the Federal Register of April 3, 2020 (85 FR 18989), we
published a 60-day notice requesting public comment on the proposed
collection of information. Although two comments were received, they
were not responsive to the four collection of information topics
solicited and therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Focus groups....................             800               1             800            1.75           1,400
Customer comment cards/forms....           1,325               1           1,325           * .25          331.25
Small discussion groups.........             800               1             800            1.75           1,400
Customer satisfaction surveys...          12,000               1          12,000    [dagger] .33           3,960
Usability Studies...............             800               1             800            1.75           1,400
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............        8,491.25
----------------------------------------------------------------------------------------------------------------
* (15 minutes).
[dagger] (20 minutes).

    In the 60-day notice published on April 3, 2020, the number of
responses and number of burden hours did not match OMB approved
inventory. This notice corrects the burden in table 1 of that notice.
In addition, the burden for this collection of information has
increased by 800 responses from 14,925 to 15,725 responses due to an
inadvertent omission of responses of usability studies for this
collection. This addition to responses will correct the number of
responses for this collection. The burden hours in OMB's inventory will
remain the same.

    Dated: October 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24422 Filed 11-3-20; 8:45 am]
BILLING CODE 4164-01-P