82_FR_47947 82 FR 47750 - Agricultural Biotechnology Education and Outreach Initiative; Public Meetings; Request for Comments

82 FR 47750 - Agricultural Biotechnology Education and Outreach Initiative; Public Meetings; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 197 (October 13, 2017)

Page Range47750-47752
FR Document2017-22172

The Food and Drug Administration (FDA or we) is announcing the following public meetings entitled ``Agricultural Biotechnology Education and Outreach Initiative.'' The purpose of the public meetings is to provide the public with an opportunity to share information, experiences, and suggestions to help inform the development of this education and outreach initiative.

Federal Register, Volume 82 Issue 197 (Friday, October 13, 2017)
[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)]
[Notices]
[Pages 47750-47752]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22172]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5991]


Agricultural Biotechnology Education and Outreach Initiative; 
Public Meetings; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meetings; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
following public meetings entitled ``Agricultural Biotechnology 
Education and Outreach Initiative.'' The purpose of the public meetings 
is to provide the public with an opportunity to share information, 
experiences, and suggestions to help inform the development of this 
education and outreach initiative.

DATES: The public meetings will be held on November 7, 2017, in 
Charlotte, North Carolina, and on November 14, 2017, in San Francisco, 
California. Submit either electronic or written comments by November 
17, 2017. See the SUPPLEMENTARY INFORMATION section for registration 
date and information.

ADDRESSES: The public meetings will be held at:
     The Omni Charlotte, 132 East Trade St., Charlotte, NC 
28202 on November 7, 2017, and
     The San Francisco Marriott Marquis, 780 Mission St., San 
Francisco, CA 94103 on November 14, 2017.
    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 November 17, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 17, 2017. 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

[[Page 47751]]

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-2017-N-5991 for ``Agricultural Biotechnology Education and Outreach 
Initiative; Public Meetings; Request for Comments.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
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.thefederalregister.org/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: For questions regarding registration 
to attend a meeting: Simone Katz, Strategic Results, 101 Lakeforest 
Blvd., Suite 390, Gaithersburg, MD 20877, 240-449-8427, 
[email protected]. For all other questions: Juanita 
Yates, Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1731, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The Consolidated Appropriations Act, 2017 (Pub. L. 115-31) 
stipulates that the Commissioner of Food and Drugs, in coordination 
with the Secretary of Agriculture, will use appropriated funds to 
provide consumer outreach and education regarding agricultural 
biotechnology and biotechnology-derived food products and animal feed, 
including through publication and distribution of science-based 
educational information on the environmental, nutritional, food safety, 
economic, and humanitarian impacts of such biotechnology.
    FDA is responsible for promoting and protecting the public health, 
including by ensuring that the nation's food supply is safe and 
nutritious. FDA provides information and outreach to a variety of 
audiences along with extensive, hands-on food safety and nutrition 
education programs for educators, health professionals, and consumers. 
Educational materials are targeted to consumers in general, as well as 
to specific groups such as children/youth, older Americans, underserved 
populations, individuals with weakened immune systems (related to food 
safety), pregnant women, and other subpopulations.
    To further our public health mission, we develop food safety and 
nutrition outreach initiatives in conjunction with non-Federal 
organizations and individuals, including teachers, community leaders, 
health educators, animal owners, and private and public health 
professionals, to increase awareness of and provide education on food 
safety and nutrition.
    In developing and implementing the Agricultural Biotechnology 
Education and Outreach Initiative, FDA will coordinate with the U.S. 
Department of Agriculture (USDA). We also will collaborate with other 
U.S. Federal Government Agencies, and public and private organizations 
as needed. These interactions will help us to develop a comprehensive 
and thorough framework for consumer education and awareness of the 
environmental, nutritional, food safety, economic, and humanitarian 
impacts of agricultural biotechnology. We believe public comment will 
be helpful to inform the development of this education and outreach 
initiative.

II. Topics for Discussion at the Public Meetings

    FDA is holding two public meetings, one in North Carolina and one 
in California, to provide the public with an opportunity to provide 
comments related to FDA's Agricultural Biotechnology Education and 
Outreach Initiative. We invite the public to share information, 
experiences, and suggestions that can help inform the development of 
the education and outreach initiative. We invite interested persons, 
including those participating in the public meetings, to respond to the 
following questions specifically regarding agricultural biotechnology 
and biotechnology-derived food products and animal feed:
    1. What are the specific topics, questions, or other information 
that consumers would find most useful, and why?
    2. Currently, how and from where do consumers most often receive 
information on this subject?
    3. How can FDA (in coordination with USDA) best reach consumers 
with science-based educational information on this subject?
    The comments received will help FDA identify education goals, 
messaging, and dissemination strategies

[[Page 47752]]

for FDA's Agricultural Biotechnology Education and Outreach Initiative.

III. Participating in the Public Meeting

    Registration: To register for a public meeting, please include your 
name, title, firm name, address, and phone and fax numbers in your 
registration information and send to: Simone Katz, Strategic Results, 
101 Lakeforest Blvd., Suite 390, Gaithersburg, MD 20877, 240-449-8427, 
Fax: 240-641-9042, email: [email protected]. You can 
register for one or both meetings.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by October 30, 2017, for the Charlotte, NC, 
meeting and must register by November 6, 2017, for the San Francisco, 
CA, meeting. 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 you need special accommodations due to a disability, please 
contact Simone Katz, Strategic Results, 101 Lakeforest Blvd., Suite 
390, Gaithersburg, MD 20877, 240-449-8427, Fax: 240-641-9042, email: 
[email protected] no later than October 20, 2017, for 
the Charlotte, NC, meeting and no later than October 27, 2017, for the 
San Francisco, CA, meeting.
    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, and request time for 
a joint presentation, or submit requests for designated representatives 
to participate in the focused sessions. 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 October 24, 2017, for the 
meeting in Charlotte, NC, and by November 1, 2017, for the meeting in 
San Francisco, CA. All requests to make oral presentations must be 
received by October 20, 2017, for the meeting in Charlotte, NC, and by 
October 27, 2017, for the meeting in San Francisco, CA.
    Streaming Webcast of the Public Meeting: Each public meeting will 
also be webcast. Individuals who wish to participate by webcast are 
asked to preregister at: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm
    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 Web site addresses in this document, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of each 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
    Other Issues for Consideration: A summary of key information on 
participating in a meeting follows:

                                                  Table 1--Information on Participation in the Meeting
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                               Request to make                         Submit either
             Date                    Address          Preregister       Electronic address         an oral            Special          electronic or
                                                                                                 presentation     accommodations      written comments
--------------------------------------------------------------------------------------------------------------------------------------------------------
November 7, 2017, from 8:30     Omni Charlotte     October 30, 2017:  Please preregister at   October 20, 2017.  October 20,       Submit Comments by
 a.m. to 1 p.m. EST.             Hotel, 132 E       Closing date for   https://www.fda.gov/                       2017: Closing     November 17, 2017,
                                 Trade St.,         registration.      Food/NewsEvents/                           date to request   to: https://
                                 Charlotte, NC                         WorkshopsMeetingsConf                      special           www.regulations.gov,
                                 28202.                                erences/default.htm.                       accommodations    or Dockets
                                                                                                                  due to a          Management Staff
                                                                                                                  disability.       (HFA-305), Food and
                                                                                                                                    Drug Administration,
                                                                                                                                    5630 Fishers Lane,
                                                                                                                                    Rm. 1061, Rockville,
                                                                                                                                    MD 20852.
November 14, 2017, from 8:30    San Francisco      November 6, 2017:  Please preregister at   October 27, 2017.  October 27,       Same as above.
 a.m. to 1 p.m. PST.             Marriott           Closing date for   https://www.fda.gov/                       2017: closing
                                 Marquis, 780       registration.      Food/NewsEvents/                           date to request
                                 Mission St., San                      WorkshopsMeetingsConf                      special
                                 Francisco, CA                         erences/default.htm.                       accommodations
                                 94103.                                                                           due to a
                                                                                                                  disability.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    You may also register via email, mail, or fax. Please include your 
name, title, firm name, address, and phone and Fax numbers in your 
registration information and send to: Simone Katz, Strategic Results, 
101 Lakeforest Blvd., Suite 390, Gaithersburg, MD 20877, 240-449-8427, 
Fax: 240-641-9042, email: [email protected].
    Individuals who wish to participate by webcast are asked to 
preregister at: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.

    Dated: October 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22172 Filed 10-12-17; 8:45 am]
 BILLING CODE 4164-01-P



                                                    47750                         Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices

                                                    docket number, found in brackets in the                 approval procedure’’ with new                         DEPARTMENT OF HEALTH AND
                                                    heading of this document, into the                      incentives for drug development in the                HUMAN SERVICES
                                                    ‘‘Search’’ box and follow the prompts                   form of exclusivities and patent term
                                                    and/or go to the Dockets Management                     extensions. With the passage of the                   Food and Drug Administration
                                                    Staff, 5630 Fishers Lane, Rm. 1061,                     Hatch-Waxman Amendments, the FD&C                     [Docket No. FDA–2017–N–5991]
                                                    Rockville, MD 20852.                                    Act describes different routes for
                                                       You may submit comments on any                       obtaining approval of two broad                       Agricultural Biotechnology Education
                                                    guidance at any time (see 21 CFR                        categories of drug applications: New                  and Outreach Initiative; Public
                                                    10.115(g)(5)).                                          drug applications (NDAs) and                          Meetings; Request for Comments
                                                       Submit written requests for single                   abbreviated new drug applications
                                                    copies of the draft guidance to the                     (ANDAs).                                              AGENCY:    Food and Drug Administration,
                                                    Division of Drug Information, Center for                                                                      HHS.
                                                                                                               This guidance focuses on those                     ACTION: Notice of public meetings;
                                                    Drug Evaluation and Research, Food                      applications that can be submitted as
                                                    and Drug Administration, 10001 New                                                                            request for comments.
                                                                                                            ANDAs under section 505(j) of the
                                                    Hampshire Ave., Hillandale Building,                    FD&C Act, petitioned ANDAs under                      SUMMARY:    The Food and Drug
                                                    4th Floor, Silver Spring, MD 20993–                     section 505(j)(2)(C) of the FD&C Act, or              Administration (FDA or we) is
                                                    0002. Send one self-addressed adhesive                  NDAs under section 505(b)(2) of the                   announcing the following public
                                                    label to assist that office in processing               FD&C Act. This guidance does not                      meetings entitled ‘‘Agricultural
                                                    your requests. See the SUPPLEMENTARY                    discuss stand-alone NDAs.                             Biotechnology Education and Outreach
                                                    INFORMATION section for electronic
                                                                                                               This draft guidance is being issued                Initiative.’’ The purpose of the public
                                                    access to the draft guidance document.
                                                                                                            consistent with FDA’s good guidance                   meetings is to provide the public with
                                                    FOR FURTHER INFORMATION CONTACT:                                                                              an opportunity to share information,
                                                                                                            practices regulation (21 CFR 10.115).
                                                    Elizabeth Giaquinto Friedman, Center                                                                          experiences, and suggestions to help
                                                                                                            The draft guidance, when finalized, will
                                                    for Drug Evaluation and Research, Food                                                                        inform the development of this
                                                                                                            represent the current thinking of FDA
                                                    and Drug Administration, 10903 New                                                                            education and outreach initiative.
                                                                                                            on factors for applicants to consider
                                                    Hampshire Ave., Rm. 1670, Silver                                                                              DATES: The public meetings will be held
                                                                                                            when determining whether to submit an
                                                    Spring, MD 20993, 240–402–7930,                                                                               on November 7, 2017, in Charlotte,
                                                                                                            ANDA or a 505(b)(2) application. It does
                                                    elizabeth.giaquinto@fda.hhs.gov.                                                                              North Carolina, and on November 14,
                                                                                                            not establish any rights for any person
                                                    SUPPLEMENTARY INFORMATION:                              and is not binding on FDA or the public.              2017, in San Francisco, California.
                                                    I. Background                                           You can use an alternative approach if                Submit either electronic or written
                                                                                                            it satisfies the requirements of the                  comments by November 17, 2017. See
                                                       FDA is announcing the availability of                                                                      the SUPPLEMENTARY INFORMATION section
                                                                                                            applicable statutes and regulations. This
                                                    a draft guidance for industry entitled                                                                        for registration date and information.
                                                                                                            guidance is not subject to Executive
                                                    ‘‘Determining Whether to Submit an
                                                                                                            Order 12866.                                          ADDRESSES: The public meetings will be
                                                    ANDA or a 505(b)(2) Application.’’ This
                                                                                                                                                                  held at:
                                                    guidance is intended to serve as a                      II. Paperwork Reduction Act of 1995                      • The Omni Charlotte, 132 East Trade
                                                    foundational guidance to assist                                                                               St., Charlotte, NC 28202 on November 7,
                                                    applicants in determining which one of                    This draft guidance refers to
                                                                                                            previously approved collections of                    2017, and
                                                    the abbreviated approval pathways                                                                                • The San Francisco Marriott
                                                    under the FD&C Act is appropriate for                   information found in FDA regulations.
                                                                                                                                                                  Marquis, 780 Mission St., San
                                                    the submission of a marketing                           These collections of information are
                                                                                                                                                                  Francisco, CA 94103 on November 14,
                                                    application to FDA. This guidance                       subject to review by the Office of
                                                                                                                                                                  2017.
                                                    highlights criteria for submitting                      Management and Budget (OMB) under
                                                                                                                                                                     You may submit comments as
                                                    applications under the abbreviated                      the Paperwork Reduction Act of 1995
                                                                                                                                                                  follows. Please note that late, untimely
                                                    approval pathways described in section                  (44 U.S.C. 3501–3520). The collections
                                                                                                                                                                  filed comments will not be considered.
                                                    505(j) and 505(b)(2) of the FD&C Act (21                of information in 21 CFR 314.94 have
                                                                                                                                                                  Electronic comments must be submitted
                                                    U.S.C. 355(j) and 21 U.S.C. 355(b)(2),                  been approved under OMB control
                                                                                                                                                                  on or before November 17, 2017. The
                                                    respectively), identifies considerations                number 0910–0001. The collection of
                                                                                                                                                                  https://www.regulations.gov electronic
                                                    to help potential applicants determine                  information for controlled
                                                                                                                                                                  filing system will accept comments
                                                    whether an application would be more                    correspondence and pre-ANDA meeting
                                                                                                                                                                  until midnight Eastern Time at the end
                                                    appropriately submitted under section                   requests has been approved under OMB
                                                                                                                                                                  of November 17, 2017. Comments
                                                    505(j) or under section 505(b)(2) of the                control number 0910–0797.
                                                                                                                                                                  received by mail/hand delivery/courier
                                                    FD&C Act, and provides direction to                     III. Electronic Access                                (for written/paper submissions) will be
                                                    potential applicants on requesting                                                                            considered timely if they are
                                                    assistance from FDA in making this                        Persons with access to the Internet                 postmarked or the delivery service
                                                    determination.                                          may obtain the draft guidance at either               acceptance receipt is on or before that
                                                       The Drug Price Competition and                       http://www.fda.gov/Drugs/                             date.
                                                    Patent Term Restoration Act of 1984                     GuidanceCompliance
                                                    (Pub. L. 98–417) (the Hatch-Waxman                      RegulatoryInformation/Guidances/                      Electronic Submissions
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    Amendments) added section 505(b)(2)                     default.htm or http://                                  Submit electronic comments in the
                                                    and 505(j) of the FD&C Act, which                       www.regulations.gov.                                  following way:
                                                    describe abbreviated approval pathways                                                                          • Federal eRulemaking Portal:
                                                                                                              Dated October 10, 2017.
                                                    for drug products regulated by the                                                                            https://www.regulations.gov. Follow the
                                                    Agency under the FD&C Act. The Hatch-                   Anna K. Abram,                                        instructions for submitting comments.
                                                    Waxman Amendments reflect                               Deputy Commissioner for Policy, Planning,             Comments submitted electronically,
                                                    Congress’s efforts to balance the need to               Legislation, and Analysis.                            including attachments, to https://
                                                    ‘‘make available more low cost generic                  [FR Doc. 2017–22196 Filed 10–12–17; 8:45 am]          www.regulations.gov will be posted to
                                                    drugs by establishing a generic drug                    BILLING CODE 4164–01–P                                the docket unchanged. Because your


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                                                                                  Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices                                         47751

                                                    comment will be made public, you are                    www.regulations.gov. Submit both                      consumers. Educational materials are
                                                    solely responsible for ensuring that your               copies to the Dockets Management Staff.               targeted to consumers in general, as well
                                                    comment does not include any                            If you do not wish your name and                      as to specific groups such as children/
                                                    confidential information that you or a                  contact information to be made publicly               youth, older Americans, underserved
                                                    third party may not wish to be posted,                  available, you can provide this                       populations, individuals with weakened
                                                    such as medical information, your or                    information on the cover sheet and not                immune systems (related to food safety),
                                                    anyone else’s Social Security number, or                in the body of your comments and you                  pregnant women, and other
                                                    confidential business information, such                 must identify this information as                     subpopulations.
                                                    as a manufacturing process. Please note                 ‘‘confidential.’’ Any information marked                To further our public health mission,
                                                    that if you include your name, contact                  as ‘‘confidential’’ will not be disclosed             we develop food safety and nutrition
                                                    information, or other information that                  except in accordance with 21 CFR 10.20                outreach initiatives in conjunction with
                                                    identifies you in the body of your                      and other applicable disclosure law. For              non-Federal organizations and
                                                    comments, that information will be                      more information about FDA’s posting                  individuals, including teachers,
                                                    posted on https://www.regulations.gov.                  of comments to public dockets, see 80                 community leaders, health educators,
                                                      • If you want to submit a comment                     FR 56469, September 18, 2015, or access               animal owners, and private and public
                                                    with confidential information that you                  the information at: https://www.gpo.gov/              health professionals, to increase
                                                    do not wish to be made available to the                 fdsys/pkg/FR-2015-09-18/pdf/2015-                     awareness of and provide education on
                                                    public, submit the comment as a                         23389.pdf.                                            food safety and nutrition.
                                                    written/paper submission and in the                        Docket: For access to the docket to                  In developing and implementing the
                                                    manner detailed (see ‘‘Written/Paper                    read background documents or the                      Agricultural Biotechnology Education
                                                    Submissions’’ and ‘‘Instructions’’).                    electronic and written/paper comments                 and Outreach Initiative, FDA will
                                                                                                            received, go to https://                              coordinate with the U.S. Department of
                                                    Written/Paper Submissions
                                                                                                            www.regulations.gov and insert the                    Agriculture (USDA). We also will
                                                       Submit written/paper submissions as                  docket number, found in brackets in the               collaborate with other U.S. Federal
                                                    follows:                                                heading of this document, into the                    Government Agencies, and public and
                                                       • Mail/Hand delivery/Courier (for                                                                          private organizations as needed. These
                                                                                                            ‘‘Search’’ box and follow the prompts
                                                    written/paper submissions): Dockets                                                                           interactions will help us to develop a
                                                                                                            and/or go to the Dockets Management
                                                    Management Staff (HFA–305), Food and                                                                          comprehensive and thorough framework
                                                                                                            Staff, 5630 Fishers Lane, Rm. 1061,
                                                    Drug Administration, 5630 Fishers                                                                             for consumer education and awareness
                                                                                                            Rockville, MD 20852.
                                                    Lane, Rm. 1061, Rockville, MD 20852.                                                                          of the environmental, nutritional, food
                                                       • For written/paper comments                         FOR FURTHER INFORMATION CONTACT: For
                                                                                                            questions regarding registration to                   safety, economic, and humanitarian
                                                    submitted to the Dockets Management                                                                           impacts of agricultural biotechnology.
                                                    Staff, FDA will post your comment, as                   attend a meeting: Simone Katz, Strategic
                                                                                                            Results, 101 Lakeforest Blvd., Suite 390,             We believe public comment will be
                                                    well as any attachments, except for                                                                           helpful to inform the development of
                                                    information submitted, marked and                       Gaithersburg, MD 20877, 240–449–8427,
                                                                                                            simone.katz@strategicresults.com. For                 this education and outreach initiative.
                                                    identified, as confidential, if submitted
                                                    as detailed in ‘‘Instructions.’’                        all other questions: Juanita Yates, Center            II. Topics for Discussion at the Public
                                                       Instructions: All submissions received               for Food Safety and Applied Nutrition,                Meetings
                                                    must include the Docket No. FDA–                        Food and Drug Administration, 5001                       FDA is holding two public meetings,
                                                    2017–N–5991 for ‘‘Agricultural                          Campus Dr., College Park, MD 20740,                   one in North Carolina and one in
                                                    Biotechnology Education and Outreach                    240–402–1731, Juanita.yates@                          California, to provide the public with an
                                                    Initiative; Public Meetings; Request for                fda.hhs.gov.                                          opportunity to provide comments
                                                    Comments.’’ Received comments, those                    SUPPLEMENTARY INFORMATION:                            related to FDA’s Agricultural
                                                    filed in a timely manner (see                                                                                 Biotechnology Education and Outreach
                                                    ADDRESSES), will be placed in the docket                I. Background
                                                                                                                                                                  Initiative. We invite the public to share
                                                    and, except for those submitted as                         The Consolidated Appropriations Act,               information, experiences, and
                                                    ‘‘Confidential Submissions,’’ publicly                  2017 (Pub. L. 115–31) stipulates that the             suggestions that can help inform the
                                                    viewable at https://www.regulations.gov                 Commissioner of Food and Drugs, in                    development of the education and
                                                    or at the Dockets Management Staff                      coordination with the Secretary of                    outreach initiative. We invite interested
                                                    between 9 a.m. and 4 p.m., Monday                       Agriculture, will use appropriated funds              persons, including those participating in
                                                    through Friday.                                         to provide consumer outreach and                      the public meetings, to respond to the
                                                       • Confidential Submissions—To                        education regarding agricultural                      following questions specifically
                                                    submit a comment with confidential                      biotechnology and biotechnology-                      regarding agricultural biotechnology
                                                    information that you do not wish to be                  derived food products and animal feed,                and biotechnology-derived food
                                                    made publicly available, submit your                    including through publication and                     products and animal feed:
                                                    comments only as a written/paper                        distribution of science-based                            1. What are the specific topics,
                                                    submission. You should submit two                       educational information on the                        questions, or other information that
                                                    copies total. One copy will include the                 environmental, nutritional, food safety,              consumers would find most useful, and
                                                    information you claim to be confidential                economic, and humanitarian impacts of                 why?
                                                    with a heading or cover note that states                such biotechnology.                                      2. Currently, how and from where do
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    ‘‘THIS DOCUMENT CONTAINS                                   FDA is responsible for promoting and               consumers most often receive
                                                    CONFIDENTIAL INFORMATION.’’ We                          protecting the public health, including               information on this subject?
                                                    will review this copy, including the                    by ensuring that the nation’s food                       3. How can FDA (in coordination with
                                                    claimed confidential information, in our                supply is safe and nutritious. FDA                    USDA) best reach consumers with
                                                    consideration of comments. The second                   provides information and outreach to a                science-based educational information
                                                    copy, which will have the claimed                       variety of audiences along with                       on this subject?
                                                    confidential information redacted/                      extensive, hands-on food safety and                      The comments received will help
                                                    blacked out, will be available for public               nutrition education programs for                      FDA identify education goals,
                                                    viewing and posted on https://                          educators, health professionals, and                  messaging, and dissemination strategies


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                                                    47752                         Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices

                                                    for FDA’s Agricultural Biotechnology       Fax: 240–641–9042, email:                                                 Streaming Webcast of the Public
                                                    Education and Outreach Initiative.         simone.katz@strategicresults.com no                                    Meeting: Each public meeting will also
                                                                                               later than October 20, 2017, for the                                   be webcast. Individuals who wish to
                                                    III. Participating in the Public Meeting
                                                                                               Charlotte, NC, meeting and no later than                               participate by webcast are asked to
                                                       Registration: To register for a public  October 27, 2017, for the San Francisco,                               preregister at: https://www.fda.gov/
                                                    meeting, please include your name,         CA, meeting.                                                           Food/NewsEvents/
                                                    title, firm name, address, and phone and                                                                          WorkshopsMeetingsConferences/
                                                                                                  Requests for Oral Presentations:
                                                    fax numbers in your registration                                                                                  default.htm
                                                    information and send to: Simone Katz,      During  online registration you may
                                                                                                                                                                         If you have never attended a Connect
                                                    Strategic Results, 101 Lakeforest Blvd.,   indicate  if you wish to present during a
                                                                                                                                                                      Pro event before, test your connection at
                                                    Suite 390, Gaithersburg, MD 20877,         public comment session or participate
                                                                                                                                                                      https://collaboration.fda.gov/common/
                                                    240–449–8427, Fax: 240–641–9042,           in a specific session, and which topic(s)                              help/en/support/meeting_test.htm. To
                                                    email: simone.katz@                        you wish to address. We will do our                                    get a quick overview of the Connect Pro
                                                    strategicresults.com. You can register for best to accommodate requests to make                                   program, visit https://www.adobe.com/
                                                    one or both meetings.                      public comments. Individuals and                                       go/connectpro_overview. FDA has
                                                       Registration is free and based on       organizations with common interests are                                verified the Web site addresses in this
                                                    space availability, with priority given to urged to consolidate or coordinate their                               document, as of the date this document
                                                    early registrants. Persons interested in   presentations, and request time for a                                  publishes in the Federal Register, but
                                                    attending this public meeting must         joint presentation, or submit requests for                             Web sites are subject to change over
                                                    register by October 30, 2017, for the      designated representatives to participate                              time.
                                                    Charlotte, NC, meeting and must register in the focused sessions. Following the                                      Transcripts: Please be advised that as
                                                    by November 6, 2017, for the San           close of registration, we will determine                               soon as a transcript of each public
                                                    Francisco, CA, meeting. Early              the amount of time allotted to each                                    meeting is available, it will be accessible
                                                    registration is recommended because        presenter and the approximate time                                     at https://www.regulations.gov. It may
                                                    seating is limited; therefore, FDA may     each oral presentation is to begin, and                                be viewed at the Dockets Management
                                                    limit the number of participants from      will select and notify participants by                                 Staff (see ADDRESSES). A link to the
                                                    each organization. Registrants will        October 24, 2017, for the meeting in                                   transcript will also be available on the
                                                    receive confirmation when they have        Charlotte, NC, and by November 1,                                      internet at https://www.fda.gov/Food/
                                                    been accepted.                             2017, for the meeting in San Francisco,                                NewsEvents/
                                                       If you need special accommodations      CA. All requests to make oral                                          WorkshopsMeetingsConferences/
                                                    due to a disability, please contact        presentations must be received by                                      default.htm.
                                                    Simone Katz, Strategic Results, 101        October 20, 2017, for the meeting in                                      Other Issues for Consideration: A
                                                    Lakeforest Blvd., Suite 390,               Charlotte, NC, and by October 27, 2017,                                summary of key information on
                                                    Gaithersburg, MD 20877, 240–449–8427, for the meeting in San Francisco, CA.                                       participating in a meeting follows:
                                                                                              TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING
                                                                                                                                                        Request to        Special            Submit either electronic or
                                                           Date              Address           Preregister              Electronic address             make an oral     accommoda-              written comments
                                                                                                                                                       presentation         tions

                                                    November 7,         Omni Charlotte      October 30,           Please preregister at https://      October 20,     October 20,         Submit Comments by November
                                                      2017, from 8:30    Hotel, 132 E        2017: Closing          www.fda.gov/Food/                  2017.           2017: Closing        17,     2017,   to:    https://
                                                      a.m. to 1 p.m.     Trade St.,          date for reg-          NewsEvents/                                        date to re-          www.regulations.gov, or Dock-
                                                      EST.               Charlotte, NC       istration.             WorkshopsMeetingsConferen-                         quest special        ets Management Staff (HFA–
                                                                         28202.                                     ces/default.htm.                                   accommoda-           305), Food and Drug Adminis-
                                                                                                                                                                       tions due to a       tration, 5630 Fishers Lane,
                                                                                                                                                                       disability.          Rm. 1061, Rockville, MD
                                                                                                                                                                                            20852.
                                                    November 14,        San Francisco       November 6,           Please preregister at https://      October 27,     October 27,         Same as above.
                                                      2017, from 8:30     Marriott Mar-       2017: Closing         www.fda.gov/Food/                  2017.           2017: closing
                                                      a.m. to 1 p.m.      quis, 780 Mis-      date for reg-         NewsEvents/                                        date to re-
                                                      PST.                sion St., San       istration.            WorkshopsMeetingsConferen-                         quest special
                                                                          Francisco, CA                             ces/default.htm.                                   accommoda-
                                                                          94103.                                                                                       tions due to a
                                                                                                                                                                       disability.



                                                       You may also register via email, mail,                 WorkshopsMeetingsConferences/                           DEPARTMENT OF HEALTH AND
                                                    or fax. Please include your name, title,                  default.htm.                                            HUMAN SERVICES
                                                    firm name, address, and phone and Fax                       Dated: October 6, 2017.
                                                    numbers in your registration                                                                                      Food and Drug Administration
                                                                                                              Anna K. Abram,
                                                    information and send to: Simone Katz,
                                                                                                              Deputy Commissioner for Policy, Planning,
                                                    Strategic Results, 101 Lakeforest Blvd.,                                                                          [Docket No. FDA–2017–N–5953]
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                                                                              Legislation, and Analysis.
                                                    Suite 390, Gaithersburg, MD 20877,
                                                    240–449–8427, Fax: 240–641–9042,
                                                                                                              [FR Doc. 2017–22172 Filed 10–12–17; 8:45 am]            Orthopaedic and Rehabilitation
                                                    email: simone.katz@                                       BILLING CODE 4164–01–P                                  Devices Panel of the Medical Devices
                                                    strategicresults.com.                                                                                             Advisory Committee; Notice of Meeting
                                                       Individuals who wish to participate                                                                            AGENCY:   Food and Drug Administration,
                                                    by webcast are asked to preregister at:                                                                           HHS.
                                                    https://www.fda.gov/Food/NewsEvents/                                                                              ACTION:   Notice.



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Document Created: 2017-10-13 04:33:53
Document Modified: 2017-10-13 04:33:53
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public meetings; request for comments.
DatesThe public meetings will be held on November 7, 2017, in Charlotte, North Carolina, and on November 14, 2017, in San Francisco, California. Submit either electronic or written comments by November 17, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information.
ContactFor questions regarding registration to attend a meeting: Simone Katz, Strategic Results, 101 Lakeforest Blvd., Suite 390, Gaithersburg, MD 20877, 240-449-8427, [email protected] For all other questions: Juanita Yates, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1731, [email protected]
FR Citation82 FR 47750 

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