[Federal Register: September 27, 2010 (Volume 75, Number 186)]
[Notices]
[Page 59254-59256]
[DOCID:fr27se10-80]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

September 20, 2010.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2746-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, L.L.C. submits tariff filing per
35.12: Interregional Agreements baseline to be effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5140.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2747-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, L.L.C. submits executed Wholesale
Market Participation Agreement with SX Landfill Energy, LLC et al.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-0212.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2748-000.
    Applicants: Entergy Arkansas, Inc.
    Description: Entergy Arkansas, Inc. submits tariff filing per
35.13(a)(2)(iii: Entergy Services, Inc. to be effective 11/16/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5145.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2749-000.
    Applicants: Emera Energy Services Subsidiary No. 4 LLC.
    Description: Emera Energy Services Subsidiary No. 4 LLC submits
tariff filing per 35.12: EES Sub 4 MBR Tariff to be effective 9/20/
2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5147.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2750-000.
    Applicants: The Order of St. Benedict of New Hampshire.
    Description: The Order of St. Benedict of New Hampshire submits
application for authorization to make wholesale sales of energy and
capacity at negotiated market based rates.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-0213.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2751-000.
    Applicants: Renaissance Power, L.L.C.
    Description: Renaissance Power, L.L.C. submits tariff filing per
35.12: Market-Based Rate Tariff in Compliance with Order No. 714 to be
effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5151.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2752-000.
    Applicants: Emera Energy Services Subsidiary No. 5 LLC.
    Description: Emera Energy Services Subsidiary No. 5 LLC submits
tariff filing per 35.12: EES Sub 5 MBR Tariff to be effective 9/20/
2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5152.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2753-000.
    Applicants: Domtar.
    Description: Domtar submits tariff filing per 35.12: Baseline
eTariff Filing Pursuant to Order No. 714 to be effective 9/20/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5153.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2754-000.
    Applicants: New England Wire Technologies Corporation.
    Description: New England submits application for authorization to
make wholesale sales of energy and capacity at negotiated market based
rates.
    Filed Date: 09/17/2010.

    Accession Number: 20100917-0211.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2755-000.
    Applicants: Las Vegas Power Company, LLC.
    Description: Las Vegas Power Company, LLC submits tariff filing per
35.12: Market-Based Rate Tariff in Compliance with Order No. 714 to be
effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5155.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2756-000.
    Applicants: Griffith Energy LLC.
    Description: Griffith Energy LLC submits tariff filing per 35.12:
Market-Based Rate Tariff in Compliance with Order No. 714 to be
effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5157.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2757-000.
    Applicants: Arlington Valley, LLC.
    Description: Arlington Valley, LLC submits tariff filing per 35.12:
Market-Based Rate Tariff in Compliance with Order No. 714 to be
effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5161.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2758-000.
    Applicants: EnergyConnect, Inc.
    Description: EnergyConnect, Inc. submits tariff filing per 35.12:
Energy Connect, Inc. Rate Schedule FERC No. 1 to be effective 11/17/
2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5165.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2759-000.
    Applicants: Bridgeport Energy, LLC.
    Description: Bridgeport Energy, LLC submits tariff filing per
35.12: Market-Based Rate Tariff in Compliance with Order No. 714 to be
effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5170.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2760-000.
    Applicants: Waterbury Generation LLC.
    Description: Request for Waiver of Unreserved Transmission Use
Penalties, Shortened Notice Period and Expedited Approval of Waterbury
Generation LLC.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5195.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2761-000
    Applicants: Fulcrum Power Marketing LLC
    Description: Fulcrum Power Marketing LLC submits tariff filing per
35.12: Fulcrum Market-Based Rate Tariff to be effective 9/21/2010.
    Filed Date: 09/20/2010
    Accession Number: 20100920-5030
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2762-000.
    Applicants: Linde Energy Services, Inc.
    Description: Linde Energy Services, Inc. submits tariff filing per
35.12: MBRA Tariff to be effective 9/20/2010.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5036.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2763-000.
    Applicants: Bangor Hydro Electric Company.
    Description: Bangor Hydro Electric Company submits their proposed
tariff Wholesale Market Based Rates Power Sales Tariff, to be effective
9/21/2010.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5041.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2764-000.
    Applicants: Vantage Wind Energy LLC.
    Description: Vantage Wind Energy LLC submits tariff filing per
35.12: Baseline Filing of Market-Based Rate Tariff to be effective 9/
20/2010.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5045.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2765-000.
    Applicants: Dighton Power, LLC.
    Description: Dighton Power, LLC submits tariff filing per 35.12:
Baseline Filing of Market-Based Rate Tariff to be effective 9/20/2010.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5057.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2766-000.
    Applicants: Lake Road Generating Company, L.P.
    Description: Lake Road Generating Company, L.P. submits tariff
filing per 35.12: Baseline Filing of Market-Based Rate Tariff to be
effective 9/20/2010.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5058.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2767-000.
    Applicants: MASSPOWER.
    Description: MASSPOWER submits tariff filing per 35.12: Baseline
Filing of Market-Based Rate Tariff to be effective 9/20/2010.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5059.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2768-000.
    Applicants: Empire Generating Co, LLC.
    Description: Empire Generating Co, LLC submits tariff filing per
35.12: Baseline Filing of Market-Based Rate Tariff to be effective 9/
20/2010.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5060.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2769-000.
    Applicants: ECP Energy I, LLC.
    Description: ECP Energy I, LLC submits tariff filing per 35.12:
Baseline Filing of Market-Based Rate Tariff to be effective 9/20/2010.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5061.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2770-000.
    Applicants: EquiPower Resources Management, LLC.
    Description: EquiPower Resources Management, LLC submits tariff
filing per 35.12: Baseline Filing of Market-Based Rate Tariff to be
effective 9/20/2010.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5062.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2771-000.
    Applicants: National Grid Generation LLC.
    Description: National Grid Generation LLC submits tariff filing per
35.12: Filing to Create Tariff Identifier for Service Agreements and
Rate Schedules to be effective 9/20/2010.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5070.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2772-000.
    Applicants: New England Hydro Transmission Corporation.
    Description: New England Hydro Transmission Corporation submits
tariff filing per 35.12: Filing to Create Tariff Identifier for Service
Agreements and Rate Schedules to be effective 9/20/2010.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5084.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2773-000.
    Applicants: New England Hydro Transmission Electric.

    Description: New England Hydro Transmission Electric Company
submits tariff filing per 35.12: Filing to Create Tariff Identifier for
Service Agreements and Rate Schedules to be effective 9/20/2010.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5090.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2774-000.
    Applicants: Arizona Solar One LLC.
    Description: Arizona Solar One LLC submits tariff filing per 35.12:
Initial Market-Based Rate Application to be effective 10/11/2010 under
ER10-02774-000. Filing Type: 400.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5106.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2775-000.
    Applicants: Beacon Power Corporation.
    Description: Beacon Power Corporation submits tariff filing per
35.12: Stephentown FERC Electric Tariff, Volume No. 1 Baseline Filing
to be effective 9/20/2010 under ER10-02775-000. Filing Type: 360.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5109.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2776-000.
    Applicants: Wells Fargo Commodities, LLC.
    Description: Wells Fargo Commodities, LLC submits tariff filing per
35.12: Wells Fargo Commodities, LLC Market-Based Rate Tariff to be
effective 9/17/2010 under ER10-02776-000. Filing Type: 360.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5111.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2777-000.
    Applicants: Avista Corporation.
    Description: Avista Corporation submits tariff filing per 35:
Compliance Filing Docket No. OA10-11 to be effective 9/22/2010 under
ER10-02777-000. Filing Type: 80.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5113.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Docket Numbers: ER10-2778-000.
    Applicants: Rainbow Energy Marketing Corp.
    Description: Rainbow Energy Marketing Corp. submits tariff filing
per 35.12: Rainbow Energy Marketing--FERC Electric Tariff to be
effective 9/20/2010 under ER10-02778-000. Filing Type: 360.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5114.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF10-669-000.
    Applicants: PowerSecure, Inc.
    Description: Self-Certification of QF of PowerSecure Inc.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5077.
    Comment Date: Not Applicable.

    Take notice that the Commission received the following electric
reliability filings:

    Docket Numbers: RD10-15-000.
    Applicants: North American Electric Reliability Corporation
    Description: Petition of the North American Electric Reliability
Corporation for Approval of Proposed Modifications to Reliability
Standards BAL-002-1; EOP-002-3; FAC-002-1; MOD-021-2; PRC-004-2; and
VAR-001-2.
    Filed Date: 09/09/2010.
    Accession Number: 20100909-5184.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 29, 2010.

    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
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.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    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>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-24078 Filed 9-24-10; 8:45 am]
BILLING CODE 6717-01-P


MEMORANDUM

DATE:		December 18, 2014

TO:		Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	EPA Region 1

SUBJECT:	December 16, 2014, Overview of Clean Power Plan for Existing Power Plants Supplemental Proposal at a New England Tribal Leaders Summit
--------------------------------------------------------------------------------

SUMMARY

      A New England Tribal Leaders Summit was held on December 16, 2014.  During the Summit, Regina Lyons provided a brief overview of the proposed Clean Power Plan for Existing Power Plants in Indian Country and U.S. Territories.

ATTENDEES

Tribal Leaders and Environmental Directors:
Chairman Rodney Butler, Mashantucket Pequot Tribal Nation
Chief Brenda Commander, Houlton Band of Maliseet Indians
Vice Chief Leslie Nicholas, Passamaquoddy Tribe: Indian Township
Chief Fred Moore, Passamaquoddy Tribe: Pleasant Point
Chief Kirk Francis, Penobscot Indian Nation
Chairman Cedric Cromwell, Mashpee Wampanoag Tribe
Vice Chairwoman Jessie Baird, Mashpee Wampanoag Tribe
Chairman Tobias Vanderhoop, Wampanoag Tribe of Gay Head (Aquinnah)
Councilman Hiawatha Brown, Narragansett Indian Tribe
Councilman Normand Bernard, Aroostook Band of Micmacs
Fred Corey, Aroostook Band of Micmacs
Sharri Venno, Houlton Band of Maliseet Indians
Trevor White and Martin Dana, Passamaquoddy Tribe: Indian Township
Marvin Cling, Passamaquoddy Tribe: Pleasant Point
John Banks, Penobscot Indian Nation
Quan Tobey and Chuckie Green, Mashpee Wampanoag Tribe
Bret Stearns, Wampanoag Tribe of Gay Head (Aquinnah)
Dinalyn Spears, Narragansett Indian Tribe
Jean McInnis, Mohegan Tribe
Michael Boland, Mashantucket Pequot Tribal Nation

EPA:
Jane Nishida
Curt Spalding
Deb Szaro
Ken Moraff
Rob Maxfield
Sharon Wells
Mike Kenyon
Susan Studlien
Carl Dierker
Tim Williamson
Nancy Barmakian
Lois Adams
Andrew Byrne
Mike Stover
Danny Rodriguez
Regina Lyons
Matt Liebman
Deb Brown

Others:
JoAnn Dunn, NAICOB Executive Director (Micmac)
Crystal Rizzo, NAICOB Youth Ed. Coordinator (S. Ute)
Tory Govan, NAICOB (Mashpee)
Jesse Scott, USDA-Forest Service
Phil Quint, Aroostook Band of Micmacs
Craig Sandborn, Housing Authority Director, Aroostook Band of Micmacs
Kathy Vandiver, MIT
Cedric Woods, UMass


[Federal Register Volume 84, Number 22 (Friday, February 1, 2019)]
[Notices]
[Pages 1152-1153]
[FR Doc No: 2019-00569]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2561]

Coordinated Development of Antimicrobial Drugs and Antimicrobial
Susceptibility Test Devices; Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Coordinated Development
of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.''
This guidance is intended to assist drug sponsors and device
manufacturers who are planning to develop new antimicrobial drugs and
antimicrobial susceptibility test (AST) devices and who seek to
coordinate development of these products such that the AST device could
be cleared either at the time of new drug approval or shortly
thereafter.

DATES: The announcement of the guidance is published in the Federal
Register on February 1, 2019.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-2561 for ``Coordinated Development of Antimicrobial Drugs
and Antimicrobial Susceptibility Test Devices.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Coordinated Development of Antimicrobial Drugs and Antimicrobial
Susceptibility Test Devices'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002, or Office of
Communications, Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your request.

FOR FURTHER INFORMATION CONTACT: Ribhi Shawar, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4604, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Joseph Toerner, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993, 301-796-
1400.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance is intended to assist drug sponsors and device
manufacturers who are planning to develop new antimicrobial drugs and
AST devices and who seek to coordinate development of these products
such that the AST device could be cleared either at the time of new
drug approval or shortly thereafter. Specifically, the guidance
describes interactions between drug sponsors and device manufacturers
for coordinated development of a new antimicrobial drug and an AST
device. The guidance also explains the considerations for submitting
separate applications to the Center for Drug

Evaluation and Research and the Center for Devices and Radiological
Health when seeking clearance of an AST device coincident with, or soon
following, antimicrobial drug approval. Finally, the guidance clarifies
that the review of the new antimicrobial drug product and AST device(s)
will remain independent, and that coordinated development does not
influence the Medical Device User Fee Act and the Prescription Drug
User Fee Act review timelines for either product.
    FDA considered comments received on the draft guidance that
appeared in the Federal Register of September 21, 2016 (81 FR 64913).
FDA revised the guidance as appropriate in response to the comments.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Coordinated Development of Antimicrobial
Drugs and Antimicrobial Susceptibility Test Devices.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov or
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Persons unable to download an electronic copy of
``Coordinated Development of Antimicrobial Drugs and Antimicrobial
Susceptibility Test Devices'' may send an email request to<EMAIL_ADDRESS>or<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 1400061 and the
guidance title to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
812...............................  Investigational            0910-0078
                                     Device Exemption.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
312...............................  Investigational New        0910-0014
                                     Drug Regulations.
314...............................  Applications for FDA       0910-0001
                                     Approval to Market
                                     a New Drug.
------------------------------------------------------------------------

    Dated: January 15, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00569 Filed 1-31-19; 8:45 am]
 BILLING CODE 4164-01-P


              Supporting Statement for a Request for OMB Review
                       under the Paperwork Reduction Act

                      PART A OF THE SUPPORTING STATEMENT

A.1	IDENTIFICATION OF THE INFORMATION COLLECTION

A.1.a	Title of the Information Collection

      EPA's Design for the Environment (DfE) Logo Redesign Consultations

      ICR Numbers:   EPA ICR No. 2487.01	OMB Control No. 2070-NEW

A.1.b	Short Characterization / Abstract

      This new information collection request (ICR) is to address the consultation process that would assist the U.S. Environmental Protection Agency (EPA) with the selection of a revised logo and messaging for its Design for the Environment (DfE) Program. A key goal of the Office of Pollution Prevention and Toxics (OPPT)'s DfE Program is to work with businesses to voluntarily incorporate safer chemicals and other health and environmental considerations into the design of their products and processes. To achieve this goal, EPA relies on outreach activities and information dissemination to industry participants and the public, as well as non-governmental organizations, other federal agencies, and state and local governments.

            Through its DfE Safer Product Labeling Program, EPA has recognized more than 2,500 products that meet the Agency's stringent human health and environmental criteria. Effective outreach and communications to businesses and the public are vital to the program's success.

            DfE's logo has remained unchanged since the program began in 1992 and does not fully and effectively represent DfE's mission to advance chemical-based products that are safer for people and the environment. A redesigned logo and messaging are needed to enhance communications and for the program to reach its potential. It is important for the DfE redesign effort to be informed by consumers, manufacturing partners, retailers, and other key audiences.

            DfE's logo redesign and accompanying communication and outreach efforts could:
   * better convey the program's scientific expertise and the human health and environmental benefits of using safer products,
   * increase consumer recognition of safer products carrying the redesigned DfE logo,
   * encourage businesses to participate in the DfE Program, and
   * further drive innovation and the development of safer chemical products that protect human health and the environment.

            This ICR would enable DfE to conduct consumer focus groups, a consumer online survey to test selected redesigned logo concepts and messaging for clarity, relevance, and appeal, and post-launch consumer online surveys to gauge consumer recognition of the new logo.

A.2	NEED FOR AND USE OF THE COLLECTION

	A.2.a	Need/Authority for the Collection

      Authority for the DfE Program derives from Section 6604(b)(5) of the Pollution Prevention Act (PPA), 42 U.S.C. 13103(b)(5) (Attachment A), which directs EPA to facilitate the adoption of source-reduction techniques by businesses, and the Toxic Substances Control Act (15 U.S.C. 2601 et seq.), which encourages safety in technological innovation in chemistry. In recognition of this statutory directive, and through consultation with a broad range of stakeholders, EPA developed the DfE Program.

      Testing of DfE's logo by consumer focus groups and consumer online surveys will help ensure that the logo effectively communicates the Agency's missions under the PPA and TSCA. A logo that is clear and signals a focus on human health and the environment will increase demand for and encourage the development of safer chemical-based products, to the benefit of consumers, manufacturing partners, retailers, other stakeholders, and the environment.

      DfE has carefully tailored this ICR to ensure that it only asks for information essential to testing the qualities of the selected redesigned logo concepts.

	A.2.b	Practical Utility/Users of the Data

      The information to be collected by the DfE Program is not designed or intended to support regulatory decision-making by EPA. EPA will use the information collected in these consultations to design or verify that a new logo:  (1) better convey the program's scientific expertise and the human health and environmental benefits of using safer products, (2) increase consumer recognition of safer products carrying the redesigned DfE logo, (3) encourage businesses to participate in the DfE Program, and (4) further drive innovation and the development of safer chemical products that protect human health and the environment.

A.3	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

	A.3.a	Non-Duplication

      Respondents will not be asked to provide information that has been or is currently being collected by EPA, other federal or state agencies, or proprietary sources. The information collected by the DfE Program is unique and is not duplicative of previous information collection requests

	A.3.b	Public Notice Required Prior to ICR Submission to OMB

      Prior to submission to OMB, this ICR will be made available to the public for comment through a Federal Register notice. The public will have 60 days to provide comments. Any comments received will be given consideration when completing the supporting statement that is submitted to OMB.

	A.3.c	Consultations

      The Agency has received input from its diverse group of DfE stakeholders regarding its logo redesign. These stakeholders include chemical manufacturers, product manufacturers, non-governmental organizations, government agencies, academics, and retailers. These consultations have informed the questions included in the focus group screening questionnaires (Attachments B and C), the focus group moderator guide (Attachment D), the pre-launch consumer online survey to test logo design options (Attachment E), and the post-launch consumer online survey to gauge consumer recognition of the new logo (Attachment F). The same moderator guide will be used for each focus group.

      The focus group respondents and consumer online survey respondents will be members of the general population. There have been no consultations with the general public for this ICR because no established organization with whom EPA has a relationship can represent this sector. Instead, EPA and a contractor with experience conducting market research for branding will design the materials for the screening questionnaires, focus groups, and consumer online surveys.

	A.3.d	Effects of Less Frequent Collection

      Ten consumer focus groups will be convened to test selected DfE logo design concepts. Of the ten consumer focus groups, five will be conducted with general adult consumers and five will be conducted with consumers who consider the environment when making purchasing decisions (i.e., "leaning green" consumers). Two screeners, one for each group type, will be used to identify and recruit participants for the ten groups. The same moderator guide will be used for both types of focus groups. Each consumer focus group consultation is designed to be a one-time information collection activity with consumers specifically recruited for the DfE logo redesign. The pre-launch consumer online survey to test logo design options will be a one-time information collection activity. The three post-launch consumer online surveys will be conducted to gauge recognition of the new logo. Each post-launch consumer online survey will be one-time information collection activity.  This means that once these activities end, no additional information collection activities will be required. Without these information collection mechanisms, DfE will not have the ability to test and verify consumer perceptions and understanding of the new design and if products displaying the new logo might affect the likelihood of acceptance and use.

	A.3.e	General Guidelines

      The information collection activities discussed in this renewal ICR comply with all regulatory guidelines under 5 CFR 1320.5(d)(2).

	A.3.f	Confidentiality

      EPA does not expect that any information collected under this ICR will involve confidential business or trade secret information. The information collected will only pertain to the opinions of the respondents on the specific characteristics of the selected logo concepts as to their clarity, relevance, appeal, and likelihood of using products that display the new design. However, to the extent that any information provided during the logo testing consultations is claimed to be business confidential information, the DfE Program will handle all information claimed as such as confidential business information in accordance with Agency confidentiality procedures (see 40 CFR part 2, subpart B). The DfE Program will use information provided by consumers solely for purposes related to determining the most appropriate redesigned logo and will disclose the information only to EPA employees and EPA contractors cleared for confidential information with a specific need to know.

	A.3.g	Sensitive Questions

      The information collection activities discussed in this document do not involve any sensitive questions.

A.4	THE RESPONDENTS AND THE INFORMATION REQUESTED

	A.4.a	Respondents

      Respondents will be adult members of the general population who are consumers, including consumers who consider the environment when making purchasing decisions (i.e., "leaning green" consumers).

	A.4.b	Information Requested

   Respondents screened for focus group participation will:
   * Listen to questions, and
   * Provide answers to questions.
   Focus groups participants will:
   * Listen to directions,
   * Be presented with materials for discussion,
   * Participate in group discussions, and
   * Complete forms.
   Consumer online survey participants will:
   * Read directions,
   * Answer questions, and
   * Submit online survey.

A.5	THE INFORMATION COLLECTED  -  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

	A.5.a	Agency Activities

   EPA and its contractor will:
   * Prepare and review focus group materials,
   * Prepare and review screener questionnaires,
   * Conduct focus group screening calls,
   * Conduct focus groups,
   * Review and analyze focus group results,
   * Prepare and review pre-launch and post-launch consumer online surveys,
   * Conduct consumer online surveys,
   * Review and analyze consumer online survey results,
   * Use focus group and pre-launch consumer online survey information to inform DfE consumer logo redesign, and
   * Use post-launch consumer online survey information to evaluate consumer recognition of redesigned logo.
	A.5.b	Collection Methodology and Management

      In collecting and analyzing the information associated with this ICR, EPA and its contractor will use a telephone system and personal computers. The contractor will employ transcription to collect information from focus group participants. The transcriptions will be kept on file but will not be distributed publicly. Personal computers will be used for the consumer online surveys. Detailed information on survey resources is outlined in Part B of this Supporting Statement.

	A.5.c	Small Entity Flexibility

      No information will be collected from small entities during this information collection.

	A.5.d	Collection Schedule

      Screening calls and focus groups will be scheduled shortly after this ICR is approved. The consumer online survey to test logo design options will be distributed shortly after this ICR is approved. The consumer online survey to gauge recognition of the new logo will be distributed six to 12 months after the redesigned logo has been launched by EPA, and then two additional times during the course of the three-year approval period.

A.6	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

	A.6.a	Estimating Respondent Burden and Costs

      Table 1 presents the estimated respondent burden hours and costs associated with the information collection activities under this ICR. EPA based its burden estimates on its focus groups and online surveys conducted for similar programs.

      The average respondent burden is estimated to be 10 minutes or 0.17 hours for respondents screened for the focus groups. This estimate is based on the length of time needed to complete a screening questionnaire. There will be two sets of screening questions used for this information collection, one for general adult consumers and one for adult consumers that lean towards the purchase and use of green products. For each focus group, 90 people will be screened using the respective questionnaire. A total of 900 people will be screened as part of this information collection. There is an estimated total respondent burden of 150 hours for the ten focus group screenings.

      The average respondent burden is estimated to be 2 hours for focus group participants. This estimate is based on the length of time designated for each focus group session. There will be ten focus groups conducted during this information collection, five for general adult consumers and five for adult consumers that lean towards the purchase and use of green products. Each focus group will have 9 participants. A total of 90 people will participate in the focus groups conducted as part of this information collection. For the ten focus groups, there is an estimated total respondent burden of 180 hours.

      The average respondent burden is estimated to be 20 minutes or 0.33 hours for the pre-launch consumer online survey to test logo design options. This estimate is based on the length of time needed to complete the pre-launch consumer online survey. There will be one pre-launch survey administered as part of this information collection. The same survey will be administered to all respondents. A total of 2,000 people will complete the survey as part of this information collection. For the pre-launch consumer online survey, there is an estimated total respondent burden of 667 hours.

      The average respondent burden is estimated to be 10 minutes or 0.17 hours for the post-launch consumer online survey to gauge consumer recognition of the new logo. This estimate is based on the length of time needed to complete the post-launch consumer online survey. The will be three iterations of the post-launch consumer online survey conducted during this information collection, each of which will use the same set of questions. The same survey will be administered to all respondents. Each post-launch consumer online survey will have 2,000 respondents. A total of 6,000 people will complete the post-launch consumer online survey as part of this information collection. For the three post-launch consumer online surveys, there is an estimated total respondent burden of 1,000 hours.

      To value the respondents' time, data released on June 12, 2013 from the Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation  -  March 2013 was used. The average wage for a civilian worker, which includes private industry and state and local government workers, averaged $21.50 per hour worked in March 2013; benefits for a civilian worker averaged $9.59. The average loaded wage for a civilian worker, and therefore the estimate of the cost of a participant's time, is $31.09 per hour. No capital or operating and maintenance costs are incurred by respondents under this ICR.

      Focus group participants are typically provided with an incentive  -  usually a cash or check payment at the close of their research session. The total incentive/travel reimbursement offered to each consumer participant will be $100 for 2 hours. Survey participants receive an incentive for participating in the panel. They receive points for completion of the survey, and the points can be redeemed for cash or prizes. Survey participants will receive an estimated equivalent of $3 to $5 for completing this survey.

Table 1. Estimated Burden and Costs to Respondents
Collection Activity
                             Number of Respondents
                             Frequency of Response
                              Hours Per Response
                              Total Burden Hours
                                 Total Burden
                                      ($)
Screening for Consumer Focus Groups
                                      900
                                       1
                                     0.17
                                      150
                                                                      $4,663.50
Consumer Focus Group Interviews
                                      90
                                       1
                                       2
                                      180
                                                                      $5,596.20
Pre-Launch Consumer Online Survey
                                     2000
                                       1
                                     0.33
                                      667
                                                                     $20,726.67
Post-Launch Consumer Online Survey
                                     6000
                                       1
                                     0.17
                                     1000
                                                                     $31,090.00
Total
                                     8,990
                                      --
                                      --
                                     1,997
                                                                     $62,076.37
[1] No capital or operating and maintenance costs are incurred by respondents under this ICR.
[2] Hourly rate of $31.09 derived from Employer costs per hour worked for employee compensation and costs as a percent of total compensation: Civilian workers, by major occupational and industry group, March 2013. U.S. Department of Labor, Bureau of Labor Statistics. Available at http://www.bls.gov/news.release/archives/ecec_06122013.pdf.
	A.6.b	Estimating Agency Burden and Costs

      Table 2 presents the estimated Agency burden hours and costs associated with the information collection activities under this ICR. EPA based its burden estimates on its focus groups conducted for similar programs.

      The cost to prepare, organize and conduct the ten focus groups is $35,750. This fixed amount includes facility rental, recruiting costs, and transcription. This fixed amount also includes the $100 honorarium paid to each of the 90 focus group participants. Although the contractor will make the focus group screening calls, prepare the focus group materials, and conduct the focus groups, Agency staff will need to review the focus group materials, the screener questionnaires, and the focus group results. EPA expects that review of the focus group materials will take about 2.5 hours (0.5 managerial, 2 technical). Reviewing the focus group screening questionnaires will take about 2.5 hours (0.5 managerial, 2 technical). Reviewing the focus group results will take about 25 hours (5 managerial, 20 technical).

      The cost to prepare and conduct the four consumer online surveys is $31,500. This fixed cost includes the $12,000 cost to prepare and conduct the pre-launch consumer online survey and the $19,500 cost to prepare and conduct the three post-launch consumer online surveys. This fixed amount includes questionnaire development, programming, online fielding and results reporting. Although the contractor will prepare and conduct the consumer online surveys, Agency staff will need to review the survey content, design, and results. EPA expects that review of the survey content and design will take about 5 hours (1 managerial, 4 technical). Reviewing survey results will take about 10 hours (2 managerial, 8 technical).

      Agency labor costs are calculated based on hourly basic rates for federal employees in the Washington-Baltimore area published by the Office of Personnel Management effective January 2013. The average hourly labor rate for managerial staff is estimated as the rate for a GS-13 Step 5 employee and the average hourly labor rate for technical staff is estimated as the rate for a GS-10 Step 10 employee. These GS-level assumptions are consistent with those used in past EPA OPPT ICRs. The hourly rates were multiplied by an assumed loading factor of 1.6 to reflect Federal fringe benefits and overhead. This loading factor is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (OPPE, 1992, page 30, footnote 9).

      The resulting average hourly labor rates, rounded to the nearest dollar amount, are $77 for managerial staff and $57 for technical staff. The Agency expects most activities related to this ICR to be performed by managerial staff (20 percent) and technical staff (80 percent).

Table 2. Estimated Burden and Costs to Agency
Collection Activity
                               EPA Burden Hours
                                   EPA Costs

                                  Mgr.
$77/Hr
                               Technical
$57/Hr
                                Total EPA Hours
                                Contractor Cost
                                   EPA Cost
Consumer Focus Groups
Prepare focus group materials
                                                                            0.5
                                                                              2
                                                                            2.5
        $35,750 for ten focus groups (includes payment to participants)
                                                                        $152.50
Prepare screener questionnaires
                                                                            0.5
                                                                              2
                                                                            2.5

                                                                        $152.50
Organize and conduct focus groups
                                                                             --
                                                                             --
                                                                              0

                                                                          $0.00
Review focus group results
                                                                              5
                                                                             20
                                                                             25

                                                                      $1,525.00
Subtotal
                                                                              6
                                                                             24
                                                                             30
                                                                        $35,750
                                                                      $1,830.00
Consumer Online Surveys
Prepare consumer online surveys
                                                                              1
                                                                              4
                                                                              5
                   $31,500 for four consumer online surveys
                                                                        $305.00
Review consumer online survey results
                                                                              2
                                                                              8
                                                                             10

                                                                        $610.00
Subtotal
                                                                              3
                                                                             12
                                                                             15
                                                                        $31,500
                                                                        $915.00
Total
                                                                              9
                                                                             36
                                                                             45
                                                                        $67,250
                                                                      $2,745.00
[1] Contractor cost includes facility rental, recruiting, honorariums, and transcription.
[2] No capital or operating and maintenance costs are incurred by the Agency under this ICR.
[3] Hourly rates for Agency staff derived from Salary Table 2013-DCB, Washington-Baltimore-Northern Virginia, DC-MD-VA-WV-PA. Office of Personnel Management. Available at http://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2013/general-schedule/dcb_h.pdf.

	A.6.c	Bottom Line Burden Hours and Cost Tables

      a.	Respondent Tally

      Table 3 below summarizes the total annual estimated respondent burden and cost. These estimates represent the average burden in any given year over the three years covered by this ICR. However, the ten focus groups, their respective screening calls, the pre-launch consumer online survey, and the three post-launch consumer online surveys will only be conducted once over the three-year period.

Table 3. Total Annual Estimated Respondent Burden and Cost Summary
                            Total # of Respondents
                             Average Burden Hours
                                  Annual Cost
                                     8,990
                                     1,997
                                  $62,076.37

      b.	Agency Tally

      Table 4 below summarizes the total annual estimated Agency burden and cost (including contractor cost). These estimates represent the average burden in any given year over the three years covered by this ICR. However, the ten focus groups, their respective screening calls, and the consumer online surveys will only be conducted once over the three-year period.

Table 4. Total Annual Estimated Agency Burden and Cost Summary
                                 Burden Hours
                                  Annual Cost
                                      45
                                    $69,995

	A.6.d	Reasons for Change in Burden

      Since this is a new ICR, change in burden is not applicable.

	A.6.e	Burden Statement

      The annual public burden for this collection of information is estimated at 0.17 hours per response for screened respondents, 2 hours for respondents that participate in the focus groups, 0.33 hours per response for pre-launch consumer online survey respondents, and 0.17 hours per response for post-launch online survey respondents. Burden is defined in 5 CFR 1320.3(b).  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 number for this information collection appears above. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.

	The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPPT-2013-0403, which is available for online viewing at www.regulations.gov, or in-person viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center (EPA/DC).  The EPA/DC Public Reading Room is located in the EPA West Building, Room 3334, 1301 Constitution Ave., N.W., Washington, DC.  The EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the EPA/DC Public Reading Room is<PHONE_NUMBER>, and the telephone number for the Pollution Prevention and Toxics Docket is<PHONE_NUMBER>.

      You may submit comments regarding 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. Submit your comments, referencing Docket ID No. EPA-HQ- OPPT-2013-0403 and OMB Control No. 2070-NEW, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: Pollution Prevention and Toxics Docket, Environmental Protection Agency Docket Center (EPA/DC), Mailcode: 28221T, 1200 Pennsylvania Ave., N.W., Washington, DC 20460, and (2) OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, N.W., Washington, DC 20503.

                      PART B OF THE SUPPORTING STATEMENT

B.1	RESPONDENT UNIVERSE AND SAMPLING METHODS

 	EPA proposes the use of an online (i.e., web-based) sampling approach as a complement to the consumer focus groups described in Part A of the supporting statement. The pre-launch consumer online survey is included as Attachment F of the supporting statement; the post-launch consumer online survey is included as Attachment F of the supporting statement. The online surveys will seek a panel-based (non-probability) sample of U.S. adults ages 18 and older that has a reasonable degree of diversity in key demographic characteristics such as age, gender, education, and race/ethnicity. While the results will be weighted to the U.S. adult population, EPA does not intend to generalize the results to the overall population or produce precise estimates of population parameters using the surveys.

      To support implementation of the consumer online surveys, EPA would retain Ipsos, a vendor that maintains a preexisting representative national panel.

      The overall sampling frame for the online consumer surveys is the panel of individuals previously recruited by Ipsos (i.e., the Ipsos Online Panel) to participate in online surveys. The Ipsos Online Panel is an actively managed research access panel that uses multi-source recruitment to maintain a representative base of respondents. It includes individuals who have volunteered to take part in market research and is extensively profiled to efficiently target respondents.

   Ipsos employs a survey router (brand name is Cortex) to manage a sample so that it will be representative of a population. Ipsos follows best-in-class principles to measure and report any selection bias that arises from the use of a router:
   * Designated team to manage and monitor the router, made up of Ipsos sampling and methodology experts
   * Router management team has final authority over which studies are in the router and any prioritization decisions
   * Restricted impact of highly-targeted studies
   * Random and priority reallocation is balanced
   * Respondents allowed to opt-out of the screening process with no penalty
   * Diverse, large number of studies maintained in the router
   * Limited number of custom screening questions allowed
   * All router studies are reviewed by the router team and removed from the router if necessary
   * Key metrics monitored multiple times daily to identify potential performance issues
   * Supplier traffic is monitored daily to ensure consistency
   * Representativeness and consistency of the router population to the general population is monitored

   Panel management protocols include a series of legitimacy checks, including name/address matching using external databases, digital fingerprinting, and TrueSample. Ipsos utilizes inbuilt criteria such as the exclusion of individuals who repeatedly fail to respond to survey invitations, as well as the use of algorithms to screen out participants who exhibit undesirable survey behavior (e.g., inconsistent response, straight-lining, speeding through, etc.).

B.2	PROCEDURES FOR THE COLLECTION OF INFORMATION

      The pre-launch consumer online survey includes questions about potential program names and visual designs. It will be administered to online panels to test selected logo concepts for clarity, relevance, appeal, and likelihood of use.

      The post-launch consumer online survey includes questions about familiarity with the DfE labeling program and logo recognition.

   Ipsos conducts all of its online data collection via websites. Through the sampling process, panelists are pre-selected to answer a certain survey; the surveys are not "open access" (i.e., respondents are not self-selected), and respondents do not know the survey content. Panelists receive an invitation email with the following information:
   * Survey information (end date, survey number, survey duration, number of incentive points)
   * A unique URL that provides access to the questionnaire
   * Physical address for Ipsos
   * Member support email address
   * Link to privacy policy
   * Opt-out information

	To ensure high quality data, data submitted through the consumer online surveys will be subjected to statistical validation techniques, such as disallowing out-of-range values.

 	All data collection and analysis will be performed in compliance with OMB, Privacy Act, and Protection of Human Subjects requirements.

B.3	METHODS TO MAXIMIZE RESPONSE RATES AND DEAL WITH NON-RESPONSE

 	Ipsos' methodology for maximizing response rates includes the following:

   * Targeted recruitment through various "wide net" methodologies (e.g., email campaigns, affiliate networks, banner ads, text ads, search engine, co-registration, offline-to-online, specialized websites)
   * Use of a point system to incentivize panelists, along with sweepstakes draws. Points systems are recognized as being the best in class in online market research, as they are seen as a neutral system which does not skew the participation of specific groups of people
   * Customized incentives and materials for recruiting special targets such as mothers of babies, age group 55+, etc.
   * Continuously testing new recruitment sources and methods
   * Use of an internal data quality process that incorporates data quality checks at the survey level to reduce or eliminate random responding, illogical or inconsistent responding, overuse of item non-response, and too rapid survey completion.

B.4	TEST OF PROCEDURES OR METHODS

 	Before the online surveys are implemented, a contractor will pilot test the instrument(s) and method of data collection. Lessons from the pilot test will be identified, and changes as necessary will be incorporated into the instrument and method. All pilot tests will involve no more than nine individuals.

B.5	INDIVIDUALS CONSULTED ON STATISTICAL ASPECTS AND INDIVIDUALS COLLECTING AND/OR ANALYZING DATA

      Alan Roshwalb, PhD, will serve as the Sampling Statistician for this project. Dr. Roshwalb is a Senior Vice President at Ipsos and joined the company in 1995. He will work with the Deputy Statistician in creating the analysis plan and executing the data analyses. Dr. Roshwalb has almost twenty years of research experience. While with Ipsos, he has served as a survey program design consultant, lead data analyst, sampling consultant, and project manager on many projects for clients such as the FDA, the Army Surgeon General, the United States Postal Service (USPS), the Federal Trade Commission, the Social Security Administration, the U.S. Patent and Trademark Office (USPTO), the Consumer Product Safety Commission, the National Institutes of Health, and Kaiser Permanente. Dr. Roshwalb is a seasoned expert in the design of surveys and sampling theory and provides consultation on quality management issues including the development of performance standards to a variety of service industry clients. He has taught statistics and applied quantitative methods, and he has authored professional papers on statistical and research methodology for social science, marketing, accounting, and management periodicals such as The Accounting Review and The Journal of Business and Economic Statistics.

                    ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachments to the supporting statement are available in the public docket established for this ICR under docket identification number EPA-HQ-OPPT-2013-0403. These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in section 6(g) of the supporting statement.

Attachment A:
42 USC 13103 - Pollution Prevention Act Section 6604. Also available at online at the US House of Representatives' Office of the Law Revision Counsel's US Code website

Attachment B:

Attachment C:

Attachment D:

Attachment E:

Attachment F:
Screening Questionnaire for "Leaning Green" Consumer Focus Group

Screening Questionnaire for General Adult Consumer Focus Group

Moderator's Guide for Consumer Focus Group Session

Survey for EPA Design for the Environment (DfE) Redesign of Visual Mark:  General Adult Population Survey

Survey for EPA Design for the Environment (DfE) Post-Launch Awareness Test of New Visual Mark:  General Adult Population Survey