[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Pages 78696-78698]
[FR Doc No: 2022-27832]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-3054]

M11 Clinical Electronic Structured Harmonised Protocol;
International Council for Harmonisation; Draft Guidance for Industry;
Draft Template; and Technical Specification; 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the availability of a draft guidance for industry entitled ``M11
Clinical Electronic Structured Harmonised Protocol (CeSHarP),'' and two
supplemental documents entitled ``M11 Template,'' and ``M11 Technical
Specification.'' The draft guidance, template, and technical
specification were prepared under the auspices of the International
Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH), formerly the International Conference on
Harmonisation. The draft guidance provides recommendations for a
harmonized clinical trial protocol including the organization of
standardized content and formatting. The draft template identifies
headers, common text, and a set of data fields and terminologies that
will be the basis for efficiencies in data exchange. The technical
specification recommends the use of an open, non-proprietary standard
to enable electronic exchange of clinical protocol information. The
intent of the draft guidance and supporting documents is to create an
international standard for the content and exchange of clinical trial
protocol information facilitating review and assessment by regulators,
sponsors,

ethical oversight bodies, investigators, and other stakeholders.

DATES: Submit either electronic or written comments on the draft
guidance by February 21, 2023 to ensure that the Agency considers your
comment on this draft guidance, template, and technical specification
before it begins work on the final versions.

ADDRESSES: You may submit comments on any guidance 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-2022-D-3054 for ``M11 Clinical Electronic Structured Harmonised
Protocol (CeSHarP).'' 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, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the 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, or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Veronica Pei, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5338, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``M11 Clinical Electronic Structured Harmonised Protocol
(CeSHarP),'' and two supplemental documents entitled ``M11 Template,''
and ``M11 Technical Specification.'' The draft guidance, template, and
technical specification were prepared under the auspices of ICH. ICH
has the mission of achieving greater regulatory harmonization worldwide
to ensure that safe, effective, high-quality medicines are developed,
registered, and maintained in the most resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the
world, ICH guidelines have substantially reduced duplicative clinical
studies, prevented unnecessary animal studies, standardized the
reporting of important safety information, standardized marketing
application submissions, and made many other improvements in the
quality of global drug development and manufacturing and the products
available to patients.
    The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally, the
Membership of ICH has expanded to include other regulatory authorities
and industry associations from around the world (refer to https://www.ich.org/).
    ICH works by involving technical experts from both regulators and

industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In September 2022, the ICH Assembly endorsed the draft guideline
entitled ``M11 Clinical Electronic Structured Harmonised Protocol
(CeSHarP)'' and two supplemental documents entitled ``M11 Template,''
and ``M11 Technical Specification'' and agreed that the materials
should be made available for public comment. The draft guideline and
supplemental documents are the product of the Multidisciplinary Expert
Working Group of the ICH. Comments about these draft guidances will be
considered by FDA and the Multidisciplinary Expert Working Group.
    The draft guidance provides recommendations for a harmonized
clinical trial protocol including the organization of standardized
content and formatting. The draft template identifies headers, common
text, and a set of data fields and terminologies that will be the basis
for efficiencies in data exchange. The technical specification
recommends the use of an open, nonproprietary standard to enable
electronic exchange of clinical protocol information. The intent of the
draft guidance and supporting documents is to create an international
standard for the content and exchange of clinical trial protocol
information facilitating review and assessment by regulators, sponsors,
ethical oversight bodies, investigators, and other stakeholders.
    The draft guidance has been left in the original ICH format. The
final guidance and supporting materials will be reformatted and edited
to conform with FDA's good guidance practices regulation (21 CFR
10.115) and style before publication. The draft guidance, template, and
technical specification when finalized, will represent the current
thinking of FDA on the topics they address. They do not establish any
rights for any person and are not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 pertaining to clinical trial design
and protocols have been approved under OMB control number 0910-0014.
The collections of information pertaining to good clinical practice and
for the implementation of improved and efficient approaches to clinical
trial design have been approved under OMB control number 0910-0843.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance,
template, and technical specification at https://www.regulations.gov,
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27832 Filed 12-21-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30742-30744]
[FR Doc No: 2018-14048]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2398]

Development of Non-Traditional Therapies for Bacterial
Infections; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Development of Non-
Traditional Therapies for Bacterial Infections.'' The purpose of the
public workshop is to discuss the general development considerations of
non-traditional therapies, including pre-clinical development, early
clinical studies, and phase 3 clinical trial designs to evaluate safety
and efficacy.

DATES: The public workshop will be held on August 21, 2018, from 8:30
a.m. to 4:30 p.m. and August 22, 2018, from

8:30 a.m. to 12 noon. Submit either electronic or written comments on
this public workshop by August 15, 2018. See the SUPPLEMENTARY
INFORMATION section for registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before August 15, 2018. The https://www.regulations.gov
electronic filing system will accept comments until midnight eastern
time on August 15, 2018. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if
they are postmarked or the delivery service acceptance receipt is on or
before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (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-2018-N-2398 for ``Development of Non-Traditional Therapies for
Bacterial Infections; Public Workshop.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lori Benner and/or Jessica Barnes,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public workshop regarding development of non-
traditional therapies for bacterial infections. Discussions will focus
on pre-clinical development, early stage clinical trials, and phase 3
clinical trial designs to evaluate safety and efficacy of non-
traditional therapies intended to serve as primary or adjunctive
therapy to existing antibacterial drugs.

II. Topics for Discussion at the Public Workshop

    FDA is particularly interested in discussing pre-clinical and
clinical development of several types of non-traditional therapies,
including monoclonal antibodies, immunomodulators, lysins, and other
non-traditional therapies.
    The Agency encourages health care providers, other U.S. Government
Agencies, academic experts, industry, and other stakeholders to attend
this public workshop.

III. Participating in the Public Workshop

    Registration: Registration is free and based on space availability,
with priority given to early registrants. Persons interested in
attending this public workshop must register online by August 14, 2018,
midnight Eastern Time. To register, please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone to
[email protected].
    Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted. If time and space permit, onsite registration on the day of
the public workshop will be provided beginning at 7:30 a.m. We will let
registrants know if registration closes before the day of the public
workshop.

    If you need special accommodations due to a disability, please
contact Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION
CONTACT) no later than August 13, 2018.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session or
participate in a specific session, and which topic(s) you wish to
address. We will do our best to accommodate requests to make public
comments. Individuals and organizations with common interests are urged
to consolidate or coordinate their presentations or request time for a
joint presentation. Following the close of registration, we will
determine the amount of time allotted to each presenter and the
approximate time each oral presentation is to begin, and will select
and notify participants by August 10, 2018. All requests to make oral
presentations must be received by the close of registration on August
6, 2018. If selected for presentation, any presentation materials must
be emailed to [email protected] no later
than August 14, 2018. No commercial or promotional material will be
permitted to be presented or distributed at the public workshop.
    Streaming Webcast of the Public Workshop: This public workshop will
also be webcast at the following site: https://collaboration.fda.gov/dcontpfbi/.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. A link to the transcript will also be available on
the internet at https://www.fda.gov/Drugs/NewsEvents/ucm606052.htm.

    Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14048 Filed 6-28-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 166 (Friday, August 26, 2011)]
[Notices]
[Page 53528]
[FR Doc No: 2011-21768]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Protection of
Voluntarily Submitted Information

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on June 21, 2011, vol. 76, no. 119, pages 36168-36169. One of
the ways to have an information program designated as protected under
Section 40123 is for an air carrier or other person to submit an
application for an individual program. The FAA evaluates the
application and either publishes a designation based on the application
for public comment or denies the application.

DATES: Written comments should be submitted by September 26, 2011.

FOR FURTHER INFORMATION CONTACT: Carla Scott on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0646.
    Title: Protection of Voluntarily Submitted Information.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: To encourage people to voluntarily submit desired
information, Sec.  40123 was added to Title 49, United States Code, in
the Federal Aviation Reauthorization Act of 1996. Section 40123 allows
the Administrator, through FAA regulations, to protect from disclosure
voluntarily provided information relating to safety and security
issues. This rule imposes a negligible paperwork burden for air
carriers that choose to participate in this program. The air carrier
submits a letter notifying the Administrator that they wish to
participate in a current program.
    Respondents: Approximately 5 applicants.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 1 hour.
    Estimated Total Annual Burden: 5 hours.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street, NW., Washington,
DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on August 19, 2011.
Carla Scott,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2011-21768 Filed 8-25-11; 8:45 am]
BILLING CODE 4910-13-P


                                 ATTACHMENT G

             Moderator's Guide for Consumer Focus Group Session

                           OMB Control No. 2070-NEW
                         Approval expires x/xx/xxxx

   This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-NEW). Responses to this collection of information are voluntary. 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 public reporting and recordkeeping burden for this collection of information is estimated to be 2 hours per response. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the Regulatory Support Division Director, U.S. Environmental Protection Agency (2821T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.
Moderator's Guide for Consumer Focus Group Session  -  General Adult Consumers
Testing Awareness and Perceptions of EPA's Safer Choice Label and Alternate Labels

Need in the room:  Pencils and highlighters for all participants; an easel for the moderator.

Note: The focus group session outlined below is designed to test awareness and perceptions of the primary Safer Choice label, with options for testing alternate labels. This document contains three modules of questions: background information, questions on the Safer Choice program and label, and questions on the Design for the Environment label or other alternate labels. For a given focus group session, one to two modules of questions will be used, while ensuring that the burden does not exceed 2 hours per response.

BACKGROUND INFORMATION (RELEVANT TO ALL MODULES)

Introduction [15 minutes]
Welcome and thank you for joining us. My name is ______ and I will be your moderator for this focus group session, which is about providing information to help consumers select products with ingredients that meet stringent criteria for their effects on people, pets, and the environment. I'd like to hear how you feel about this topic, and I'm also interested in your perceptions about some visual materials, which I will show you a bit later. I want to let you know that I am not an expert in this topic; rather, I am an independent moderator trained to facilitate our discussion.

Our client for this research is the U.S. Environmental Protection Agency (EPA), located in Washington, D.C. The EPA's mission is to protect human health and the environment.  This research has been approved by the OMB, and the control number is _______. I have a copy of the burden statement associated with this research for you [hand out].

Our discussion should take about 2 hours.

Disclosure
 Observation: There is a one-way mirror with observers in the next room who are interested in hearing your views, but don't want to interrupt the conversation.
 Audio taping: This session will be recorded by audio to enable us to capture everything that is being said today. We will use the tape to write our report to our client.
 Your answers will be private to the extent permitted by law, so feel free to say exactly what is on your mind. Nothing will be attributed to any particular person in our aggregated report; however, we will be sharing all results with our client.

Ground rules
 Need to hear from everyone, one at a time please
 No right or wrong answers, want personal opinions
 Moderator is impartial, please be candid
 It's okay to be critical. If you dislike something you hear, it's fine to disagree but please be willing to offer your own views and opinions.
 If anyone needs to use the restroom, they are located [specify]. There is no need to stop the discussion.

Do you have any questions before we get started?

Participant introductions
 Brief introductions around the table  -  tell us a little about yourself (e.g., name, occupation, family, pets)

Awareness and Use of Certification Seals [10 minutes]
Let's start our session by taking a look at some products you may have seen in a local supermarket or retail store.

[Show several products in a category, perhaps cleaning products  -  include at least one with a green certification and at least one without]

 Which one of these products would you choose to purchase in the supermarket?
 Why?
 Let's look more closely at this product [pick up a product that has a green certification mark on it]
 Have you seen this mark before?
 What does it mean?

The mark on this product indicates a green certification program, which is a program intended to help consumers purchase safer and/or more environmentally sustainable products. These programs are also known as "eco-label" programs.

Are you familiar with green certification programs?
 Which ones are you familiar with? [Prompt if necessary: Cradle-to-Cradle, EcoLogo, Energy Star, EWG verified, Good Housekeeping Green Ratings, Green Seal, USDA Organic, WaterSense]
 Have you ever used any of these programs to help you decide which products to buy?

PERCEPTIONS OF THE SAFER CHOICE PROGRAM AND LABEL

Perceptions of Safer Choice Program [15 minutes]
Different certification programs have different purposes  -  for example, EnergyStar specifically helps consumer purchase products that are more energy efficient, whereas the USDA Organic program lets consumers know which products are certified organic. I want to talk about an EPA program intended to help consumers select products with ingredients that can help protect the environment and are safer for people, families, and pets. I'll distribute a description of this program, and you can read along with me.

The U.S. EPA's Safer Choice program is a voluntary program that helps protect people and the planet by certifying products that contain safer ingredients. For almost 30 years, the Environmental Protection Agency has been evaluating the human health and environmental concerns associated with chemicals and empowering businesses to make safer chemical-based products. When you see the Safer Choice label on a product it means the EPA Safer Choice scientific review team has screened each ingredient for potential human health and environmental effects and that the product contains only the safest chemical ingredients available.

 Has anyone ever heard of the Safer Choice program?
 Have you used it to help you decide which products to buy?
 What's your overall impression of this program?
 Does it sound useful to you?
 As you shop in your local supermarket or retail outlet, would it be helpful to you to have some easy way of knowing if a product has ingredients that have been determined to be safer for people or if it can help protect the environment?
 If you could get that information at a glance just by looking at the product, do you think it might influence your purchase decision?
 Why or why not?
 If the products in a particular category all cost about the same, do you think you'd choose the product that has been certified by the EPA to have ingredients that are safer for people and the environment?
 Which of those two claims would motivate you more to purchase a certified product  -  safer for people or protects the environment?

Testing Safer Choice Label [45 minutes]

I'd like to show you the Safer Choice label, which appears on product packages to let consumers know which products have been certified under this program to have ingredients that are safer for people and the environment. I'd like to get your thoughts regarding this label and whether it is effective in communicating the goals of this program.

 How would you sum up your first impression of this label?
 Would you notice it if you saw it on a product?
 Is it attractive?
 Why or why not?
 What does this label mean to you, the consumer?
 How well do you think the message comes across in this label?
 Is it easy to understand at a glance?
 Is this label credible?  Do you believe it will deliver on what the label conveys?
 Why or why not?
 Does this label give you any information about the product's impact on human health?
 If so, what does it tell you?
 Does this label give you any information about the product's impact on the environment?
 If so, what does it tell you?
 Does this label provide enough information to help you choose between various products in a category?
 Why or why not?
 How well do you think the name conveys what the program is trying to do?
 How well do you think the visual label conveys what the program is trying to do?
 How likely would you be to use this label to help you decide on a product to purchase?
 Why or why not?
 Have you seen products in stores with this label on it?
 Where?  When? Was it prominently displayed?  Was there an abundance of product stock?
 Have you purchased a product with this design on it?
 When?  Which product?  Which store?  Did you enjoy the product?
 Why did you purchase?  What motivated you?
 Have you seen promotions for products with this label?
 Where?  When?  Was it compelling?  Why?  Why not?
 What would it take for you to seek out a product with this label?
 Why is this important to you? Unimportant to you?
 What is most important to you when deciding which products in this category you would purchase?
 Why?  Is this always the case?  Why or Why not?
 What is your thought process when deciding to purchase these products?  Are you apprehensive?  Do you not give it much thought?  Why? Why not?
 Do you discuss these purchasing decisions in your family?  Among friends?  Neighbors?
 Who or what do you consider influential in terms of impacting your purchasing decisions or attitudes toward products?  Why?

PERCEPTIONS OF AN ALTERNATE (E.G., DfE) LABEL

Testing Alternate (e.g., DfE) Label [45 minutes]

Background information will be provided on the alternate label being tested. For example: I'd like to show you a label that EPA may allow to be used on certified antimicrobial products, such as disinfectants and sanitizers, that have chemical ingredients that meet stringent criteria for human health and environmental effects. This label is called the Design for the Environment, or DfE, label.

I'd like to get your thoughts regarding this [alternate] label and whether it is effective in communicating the goals of this program.

                                     Label
                                     Label

 How would you sum up your first impression of this label?
 Would you notice it if you saw it on a product?
 Is it attractive?
 Why or why not?
 What does this label mean to you, the consumer?
 How well do you think the message comes across in this label?
 Is it easy to understand at a glance?
 Is this label credible?  Do you believe it will deliver on what the label conveys?
 Why or why not?
 Does this label give you any information about the product's impact on human health?
 If so, what does it tell you?
 Does this label give you any information about the product's impact on the environment?
 If so, what does it tell you?
 Does this label provide enough information to help you choose between various products in a category (e.g., disinfectant products)?
 Why or why not?
 How well do you think the name conveys what the program is trying to do?
 How well do you think the visual label conveys what the program is trying to do?
 How likely would you be to use this label to help you decide on a product to purchase?
 Why or why not?
 What would it take for you to seek out a product with this label?
 Why is this important to you? Unimportant to you?
 What is most important to you when deciding which products in this category you would purchase?
 Why?  Is this always the case?  Why or Why not?
 What is your thought process when deciding to purchase these products?  Are you apprehensive?  Do you not give it much thought?  Why? Why not?
 Do you discuss these purchasing decisions in your family?  Among friends?  Neighbors?
 Who or what do you consider influential in terms of impacting your purchasing decisions or attitudes toward products?  Why?

For comparison, I'd also like to show you another label, the Safer Choice label. This is a label that EPA allows to be used on certified cleaning products other than disinfectants that have chemical ingredients that meet stringent criteria for human health and environmental effects. In other words, products with the label contain only safer ingredients.

I'd like to get your thoughts on how this label compares to the [DfE] label that we just discussed, and whether the two are similar.

 Does the [DfE] label seem similar to the Safer Choice label?
 Why or why not?
 Would you say the two labels are similar or the same?
 What are the differences between the two labels?
 If you were in the store shopping for household goods, do you think you would be able to tell the difference between these two labels?
 What makes it clear that the labels are different?
 What message do you think EPA is trying to convey about products with the DfE label?
 Would it be fair to say that the two labels are similar but distinct?
 Why or why not?

CONCLUSION (RELEVANT TO ALL MODULES)

Communication Preferences and Wrap Up [5 minutes]

As a result of our discussion tonight, are you interested in learning more about the EPA program we have discussed this evening?

What would be the best way to provide additional information for you?  Where would you be most likely to pay attention to it?  [e.g., website, product packaging, point of purchase information or display, magazines or newspapers]

On behalf of the U.S. EPA, I want to thank all of you for your input today. Please stop by the reception desk to receive an incentive for joining us this evening. [Collect all materials]


[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Notices]
[Pages 14800-14801]
[FR Doc No: 2017-05643]

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DEPARTMENT OF TRANSPORTATION

Bureau of Transportation Statistics

[Docket ID Number DOT-OST-2014-0031]

Agency Information Collection: Activity Under OMB Review; Report
of Traffic and Capacity Statistics--The T-100 System

AGENCY: Bureau of Transportation Statistics (BTS), DOT.

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, Public
Law 104-13, the Bureau of Transportation Statistics invites the general
public, industry and other governmental parties to comment on the
continuing need for and usefulness of DOT requiring U.S. and foreign
air carriers to file traffic and capacity data pursuant to 14 CFR
241.19 and Part 217, respectively. These reports are used to measure
air transportation activity to, from, and within the United States.

DATES: Written comments should be submitted by May 22, 2017.

FOR FURTHER INFORMATION CONTACT: Jennifer Rodes, Office of Airline
Information, RTS-42, Room E34-420, OST-R, BTS, 1200 New Jersey Avenue
SE., Washington, DC 20590-0001, Telephone Number<PHONE_NUMBER>, Fax
Number<PHONE_NUMBER> or EMAIL<EMAIL_ADDRESS>    Comments: Comments should identify the associated OMB approval
#2138-0040 and Docket ID Number DOT-OST-2014-0031. Persons wishing the
Department to acknowledge receipt of their comments must submit with
those comments a self-addressed stamped postcard on which the following
statement is made: Comments on OMB #2138-0040, Docket--DOT-OST-2014-
0031. The postcard will be date/time stamped and returned.

ADDRESSES: You may submit comments identified by DOT Docket ID Number
DOT-OST-2014-0031 by any of the following methods:
    Federal eRulemaking Portal: Go to http://www.regulations.gov.
Follow the online instructions for submitting comments.
    Mail: Docket Services: U.S. Department of Transportation, 1200 New
Jersey Avenue SE., West Building Ground Floor, Room W12-140,
Washington, DC 20590-0001.
    Hand Delivery or Courier: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET, Monday
through Friday, except Federal holidays.
    Fax:<PHONE_NUMBER>.
    Instructions: Identify docket number, DOT-OST-2014-0031, at the
beginning of your comments, and send two copies. To receive
confirmation that DOT received your comments, include a self-addressed
stamped postcard. Internet users may access all comments received by
DOT at http://www.regulations.gov. All comments are posted
electronically without charge or edits, including any personal
information provided.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://DocketInfo.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov. or the street
address listed above. Follow the online instructions for accessing the
dockets.

Electronic Access

    You may access comments received for this notice at http://www.regulations.gov, by searching docket DOT-OST-2014-0031.

SUPPLEMENTARY INFORMATION:
    OMB Approval No. 2138-0040.
    Title: Report of Traffic and Capacity Statistics--The T-100 System.
    Form No.: Schedules T-100 and T-100(f).
    Type of Review: Extension of a currently approved collection.
    Respondents: Certificated, commuter and foreign air carriers that
operate to, from or within the United States.

T100 Form

    Number of Respondents: 119.
    Number of Annual Responses: 1,428.
    Total Burden per Response: 6 hours.
    Total Annual Burden: 8,568 hours.

T100F Form

    Number of Respondents: 190.
    Number of Annual Responses: 2,280.
    Total Burden per Response: 2 hours.
    Total Annual Burden: 4,560 hours.
    Needs and Uses:

Airport Improvement

    The Federal Aviation Administration uses enplanement data for U.S.
airports to distribute the annual Airport Improvement Program (AIP)
entitlement funds to eligible primary airports, i.e., airports which
account for more than 0.01 percent of the total passengers enplaned at
U.S. airports. Enplanement data contained in Schedule T-100/T-100(f)
are the sole data base used by the FAA in determining airport funding.
U.S. airports receiving significant service from foreign air carriers
operating small aircraft could be receiving less than their fair share
of AIP entitlement funds. Collecting Schedule T-100(f) data for small
aircraft operations will enable the FAA to more fairly distribute these
funds.

Air Carrier Safety

    The FAA uses traffic, operational and capacity data as important
safety indicators and to prepare the air carrier traffic and operation
forecasts that are used in developing its budget and staffing plans,
facility and equipment funding levels, and environmental impact and
policy studies. The FAA monitors changes in the number of air carrier
operations as a way to allocate inspection resources and in making
decisions as to increased safety surveillance. Similarly, airport
activity statistics are used by the FAA to develop airport profiles and
establish priorities for airport inspections.

Acquisitions and Mergers

    While the Justice Department has the primary responsibility over
air carrier acquisitions and mergers, the Department reviews the
transfer of

international routes involved to determine if they would substantially
reduce competition, or determine if the transaction would be
inconsistent with the public interest. In making these determinations,
the proposed transaction's effect on competition in the markets served
by the affected air carriers is analyzed. This analysis includes, among
other things, a consideration of the volume of traffic and available
capacity, the flight segments and origins-destinations involved, and
the existence of entry barriers, such as limited airport slots or gate
capacity. Also included is a review of the volume of traffic handled by
each air carrier at specific airports and in specific markets which
would be affected by the proposed acquisition or merger. The Justice
Department uses T-100 data in carrying out its responsibilities
relating to airline competition and consolidation.

Traffic Forecasting

    The FAA uses traffic, operational and capacity data as important
safety indicators and to prepare the air carrier traffic and operation
forecasts. These forecast as used by the FAA, airport managers, the
airlines and others in the air travel industry as planning and
budgeting tools.

Airport Capacity Analysis

    The mix of aircraft type are used in determining the practical
annual capacity (PANCAP) at airports as prescribed in the FAA Advisory
Circular Airport Capacity Criteria Used in Preparing the National
Airport Plan. The PANCAP is a safety-related measure of the annual
airport capacity or level of operations. It is a predictive measure
which indicates potential capacity problems, delays, and possible
airport expansions or runway construction needs. If the level of
operations at an airport exceeds PANCAP significantly, the frequency
and length of delays will increase, with a potential concurrent risk of
accidents. Under this program, the FAA develops ways of increasing
airport capacity at congested airports.

Airline Industry Status Evaluations

    The Department apprizes Congress, the Administration and others of
the effect major changes or innovations are having on the air
transportation industry. For this purpose, summary traffic and capacity
data as well as the detailed segment and market data are essential.
These data must be timely and inclusive to be relevant for analyzing
emerging issues and must be based upon uniform and reliable data
submissions that are consistent with the Department's regulatory
requirements.

Mail Rates

    The Department is responsible for establishing international and
intra-Alaska mail rates. International mail rates are set based on
scheduled operations in four geographic areas: Trans-border, Latin
America, operations over the Atlantic Ocean and operations over the
Pacific Ocean. Separate rates are set for mainline and bush Alaskan
operations. The rates are updated every six months to reflect changes
in unit costs in each rate-making entity. Traffic and capacity data are
used in conjunction with cost data to develop the required unit cost
data.

Essential Air Service

    The Department reassesses service levels at small domestic
communities to assure that capacity levels are adequate to accommodate
current demand

System Planning at Airports

    The FAA is charged with administering a series of grants that are
designed to accomplish the necessary airport planning for future
development and growth. These grants are made to state metropolitan and
regional aviation authorities to fund needed airport systems planning
work. Individual airport activity statistics, nonstop market data, and
service segment data are used to prepare airport activity level
forecasts.

Review of IATA Agreements

    The Department reviews all of the International Air Transport
Association (IATA) agreements that relate to fares, rates, and rules
for international air transportation to ensure that the agreements meet
the public interest criteria. Current and historic summary traffic and
capacity data, such as revenue ton-miles and available ton-miles, by
aircraft type, type of service, and length of haul are needed to
conduct these analyses: To (1) develop the volume elements for
passenger/cargo cost allocations, (2) evaluate fluctuations in volume
of scheduled and charter services, (3) assess the competitive impact of
different operations such as charter versus scheduled, (4) calculate
load factors by aircraft type, and (5) monitor traffic in specific
markets.

Foreign Air Carriers Applications

    Foreign air carriers are required to submit applications for
authority to operate to the United States. In reviewing these
applications the Department must find that the requested authority is
encompassed in a bilateral agreement, other intergovernmental
understanding, or that granting the application is in the public
interest. In the latter cases, T-100 data are used in assessing the
level of benefits that carriers of the applicant's homeland presently
are receiving from their U.S. operations. These benefits are compared
and balanced against the benefits U.S. carriers receive from their
operations to the applicant's homeland.

Air Carrier Fitness

    The Department determines whether U.S. air carriers are and
continue to be fit, willing and able to conduct air service operations
without undue risk to passengers and shippers. The Department monitors
a carrier's load factor, operational, and enplanement data to compare
with other carriers with similar operating characteristics. Carriers
that expand operations at a high rate are monitored more closely for
safety reasons.

International Civil Aviation Organization

    Pursuant to an international agreement, the United States is
obligated to report certain air carrier data to the International Civil
Aviation Organization (ICAO). The traffic data supplied to ICAO are
extracted from the U.S. air carriers' Schedule T-100 submissions.
    The Confidential Information Protection and Statistical Efficiency
Act of 2002 (44 U.S.C. 3501 note), requires a statistical agency to
clearly identify information it collects for non-statistical purposes.
BTS hereby notifies the respondents and the public that BTS uses the
information it collects under this OMB approval for non-statistical
purposes including, but not limited to, publication of both
Respondent's identity and its data, submission of the information to
agencies outside BTS for review, analysis and possible use in
regulatory and other administrative matters.

    Issued on March 15, 2017.
William Chadwick, Jr.,
Director, Office of Airline Information, Bureau of Transportation
Statistics.
[FR Doc. 2017-05643 Filed 3-21-17; 8:45 am]
 BILLING CODE 4910-9X-P


[Federal Register Volume 83, Number 103 (Tuesday, May 29, 2018)]
[Notices]
[Pages 24584-24585]
[FR Doc No: 2018-11438]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2012-0050; FMCSA-2015-0119; FMCSA-2015-0320]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to renew exemptions for nine
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: The exemptions were applicable on January 21, 2018. The
exemptions expire on January 21, 2020.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
e.t., Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

II. Background

    On February 27, 2018, FMCSA published a notice announcing its
decision to renew exemptions for nine individuals from the epilepsy and
seizure disorders prohibition in 49 CFR 391.41(b)(8) to operate a CMV
in interstate commerce and requested comments from the public (83 FR
8568). The public comment period ended on March 29, 2018 and one
comment was received.
    As stated in the previous notice, FMCSA has evaluated the
eligibility of these applicants and determined that renewing these
exemptions would achieve a level of safety equivalent to or greater
than the level that would be achieved by complying with the current
regulation 49 CFR 391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria to assist Medical Examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391--MEDICAL
ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8), paragraphs
3, 4, and 5.]

III. Discussion of Comments

    FMCSA received one comment in this proceeding. This comment
supported FMCSA's decision to grant these exemptions to drivers with
seizure disorders.

IV. Conclusion

    Based upon its evaluation of the nine renewal exemption
applications and comments received, FMCSA announces its' decision to
exempt the following drivers from the epilepsy and seizure disorders
prohibition in 49 CFR 391.41 (b)(8):
    As of March 29, 2018, and in accordance with 49 U.S.C. 31136(e) and
31315, the following nine individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers. (83 FR
8568):

Thomas A. De Angelo (IL)
Nathan L. Dermer (AK)
Daniel L. Halstead (NV)
Toriano T. Mitchell (OH)
Thomas A. Mitman (NY)
Diana J. Mugford (VT)
Tyler W. Schaefer (ME)
Alvin C. Strite (PA)
Thomas B. Vivirito (PA)

    The drivers were included in docket numbers FMCSA-2012-0050; FMCSA-
2015-0119; FMCSA-2015-0320. Their exemptions are applicable as of
January 21, 2018, and will expire on January 21, 2020.
    In accordance with 49 U.S.C. 31315, each exemption will be valid
for two years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption

would not be consistent with the goals and objectives of 49 U.S.C.
31136 and 31315.

    Issued on: May 17, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-11438 Filed 5-25-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26750-26751]
[FR Doc No: 2012-10940]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2012-0258; FRL-9344-5]

Agency Information Collection Activities; Proposed Collection;
Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this
document announces that EPA is planning to submit a request to renew an
existing approved Information Collection Request (ICR) to the Office of
Management and Budget (OMB). This ICR, entitled: ``Notification of
Chemical Exports--TSCA Section 12(b)'' and identified by EPA ICR No.
0795.14 and OMB Control No. 2070-0030, is scheduled to expire on March
31, 2013. Before submitting the ICR to OMB for review and approval, EPA
is soliciting comments on specific aspects of the information
collection renewal.

DATES: Comments must be received on or before July 6, 2012.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2012-0258, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Attention:
Docket ID Number EPA-HQ-OPPT-2012-0258. The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is<PHONE_NUMBER>. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2012-0258. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Mike Mattheisen, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-3077; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)),
EPA specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What should I consider when I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.

    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.
    7. Make sure to submit your comments by the deadline identified
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

III. What information collection activity or ICR does this action apply
to?

    Affected entities: Entities potentially affected by this ICR are
companies that export from the United States to foreign countries, or
that engage in wholesale sales of, chemical substances or mixtures.
    Title: Notification of Chemical Exports--TSCA Section 12(b).
    ICR number: EPA ICR No. 0795.14.
    OMB control number: OMB Control No. 2070-0030.
    ICR status: This ICR is currently scheduled to expire on March 31,
2013. 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 in title 40 of the Code of Federal Regulations (CFR), after
appearing in the Federal Register when approved, are listed in 40 CFR
part 9, are displayed either by publication in the Federal Register or
by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
for certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: Section 12(b)(2) of the Toxic Substances Control Act
(TSCA) requires that any person who exports or intends to export to a
foreign country a chemical substance or mixture that is regulated under
TSCA sections 4, 5, 6, and/or 7 submit to EPA notification of such
export or intent to export. Upon receipt of notification, EPA will
advise the government of the importing country of the U.S. regulatory
action with respect to that chemical substance or mixture. EPA uses the
information obtained from the submitter via this collection to advise
the government of the importing country. This information collection
addresses the burden associated with industry reporting of export
notifications.
    Responses to the collection of information are mandatory (see 40
CFR part 707). Respondents may claim all or part of a notice
confidential. EPA will disclose information that is covered by a claim
of confidentiality only to the extent permitted by, and in accordance
with, the procedures in TSCA section 14 and 40 CFR part 2.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 1.3
hours per response. 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 which have subsequently changed; 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.
    The ICR provides a detailed explanation of this estimate, which is
only briefly summarized here:
    Estimated total number of potential respondents: 240.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent:
12.9.
    Estimated total annual burden hours: 4,025 hours.
    Estimated total annual costs: $245,246. This includes an estimated
burden cost of $245,246 and an estimated cost of $0 for capital
investment or maintenance and operational costs.

IV. Are there changes in the estimates from the last approval?

    There is a decrease of 825 hours in the total estimated respondent
burden compared with that identified in the ICR currently approved by
OMB. This decrease reflects the net effect of a decrease in the
estimated number of TSCA section 12(b) notices sent to EPA and a
decrease in the number of firms sending notices, based on EPA's recent
experience with those submissions. This change is an adjustment.

V. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce
the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the technical person listed under
FOR FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Chemicals, Exports, Reporting and
recordkeeping requirements.

    Dated: April 25, 2012.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2012-10940 Filed 5-4-12; 8:45 am]
BILLING CODE 6560-50-P