[Federal Register Volume 74, Number 122 (Friday, June 26, 2009)]
[Notices]
[Pages 30603-30604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15107]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0260]


Reportable Food Registry; Public Workshops

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshops.

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    The Food and Drug Administration (FDA) is announcing three public 
workshops to discuss the draft guidance FDA issued on June 11, 2009, 
concerning the Congressionally-mandated Reportable Food Registry (the 
Registry). The purpose of the public workshop is to explain the purpose 
of the Registry, how it will work, and the responsibilities of persons 
required to submit a report regarding instances of reportable food to 
FDA through the reportable food electronic portal. The role of Federal, 
State, and local public health officials in voluntarily reporting 
instances of reportable food to FDA will also be discussed.
    Dates, Times, and Locations: See ``How to Participate in the 
Workshops'' in the SUPPLEMENTARY INFORMATION section of this document 
for dates and times of the workshops, closing dates for advance 
registration, requesting special accommodations due to disability, 
requesting onsite parking, and other information regarding meeting 
participation.
    Contact Person: For general questions about the workshops, to 
request onsite parking for the July 23 workshop, or for special 
accommodations due to a disability, contact Juanita Yates, Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1731, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. How to Participate in the Workshops

    Table 1 of this document provides information on participation in 
the workshops.

                                                    Table 1.
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                                  Date                 Address           Electronic Address   Other Information
----------------------------------------------------------------------------------------------------------------
First public workshop       July 23, 2009,    Harvey W. Wiley Federal   ...................  ...................
                             from 9 a.m. to    Bldg., Food and Drug
                             noon              Administration, Center
                                               for Food Safety and
                                               Applied Nutrition, 5100
                                               Paint Branch Pkwy.,
                                               College Park, MD 20740
                                               (Metro stop: College
                                               Park on the Green Line)
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[[Page 30604]]

 
    Advance registration    by July 17, 2009  We encourage you to use   http://www.fda.gov/  There is no
                                               electronic registration   Food/NewsEvents/     registration fee
                                               if possible.\1\           WorkshopsMeetingsC   for the public
                                                                         onferences/          workshops. Early
                                                                        click on the link     registration is
                                                                         to the Reportable    recommended
                                                                         Food Registry        because seating is
                                                                         Public Workshops     limited.
----------------------------------------------------------------------------------------------------------------
    Request special         by July 17, 2009  See Contact Person        ...................  ...................
     accommodations due to
     a disability
----------------------------------------------------------------------------------------------------------------
    Request onsite parking  by July 20, 2009  See Contact Person        ...................  ...................
����������������������������������������������������������������������������������������������������������������
Second public workshop      August 5, 2009,   Hyatt Regency Chicago,    ...................  ...................
                             from 9 a.m. to    151 East Wacker Dr.,
                             noon              Chicago, IL 60601
----------------------------------------------------------------------------------------------------------------
    Advance registration    by July 27, 2009  We encourage you to use   http://www.fda.gov/  There is no
                                               electronic registration   Food/NewsEvents/     registration fee
                                               if possible.\1\           WorkshopsMeetingsC   for the public
                                                                         onferences/          workshops. Early
                                                                        click on the link     registration is
                                                                         to the Reportable    recommended
                                                                         Food Registry        because seating is
                                                                         Public Workshops     limited.
----------------------------------------------------------------------------------------------------------------
    Request special         by July 27, 2009  See Contact Person        ...................  ...................
     accommodations due to
     a disability
����������������������������������������������������������������������������������������������������������������
Third public workshop       August 25, 2009,  Ronald V. Dellums         ...................  ...................
                             from 9 a.m. to    Federal Bldg., Edward
                             noon              Roybal Auditorium, 1301
                                               Clay St., 3d floor,
                                               Oakland, CA 94612
----------------------------------------------------------------------------------------------------------------
    Advance registration    by August 14,     We encourage you to use   http://www.fda.gov/  There is no
                             2009              electronic registration   Food/NewsEvents/     registration fee
                                               if possible.\1\           WorkshopsMeetingsC   for the public
                                                                         onferences/          workshops. Early
                                                                        click on the link     registration is
                                                                         to the Reportable    recommended
                                                                         Food Registry        because seating is
                                                                         Public Workshops     limited.
----------------------------------------------------------------------------------------------------------------
    Request special         by August 14,     See Contact Person        ...................  ...................
     accommodations due to   2009
     a disability
----------------------------------------------------------------------------------------------------------------
\1\ You may also register via e-mail, mail, or fax. Please include your name, title, firm name, address, and
  phone and fax numbers in your registration information and send to: Deborah Harris, EDJ Associates, Inc.,
  11300 Rockville Pike, suite 1001, Rockville, MD 20852, 240-221-4326, FAX: 301-945-4295, e-mail: [email protected]. Onsite registration will also be available at all workshop sites.

II. Background

    In the Federal Register of June 11, 2009 (74 FR 27803), FDA 
announced the availability of a draft guidance entitled ``Guidance for 
Industry: Questions and Answers Regarding the Reportable Food Registry 
as Established by the Food and Drug Administration Amendments Act of 
2007''. The draft guidance, when finalized, will assist the industry 
with complying with the Reportable Food Registry requirements 
prescribed by the Food and Drug Administration Amendments Act of 2007 
(FDAAA). FDA also announced a further delay in the implementation of 
the Registry of FDAAA until September 8, 2009, to consider any comments 
received on the draft guidance and through the agency's planned 
outreach initiatives, and to allow for further testing of the 
electronic portal for reportable foods.
    This notice announces three public workshops as part of the 
agency's planned outreach initiatives regarding the Registry.

III. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov. It may be viewed at 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and Drug Administration, 5600 Fishers 
Lane, rm. 6-30, Rockville, MD 20857.

    Dated: June 22, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-15107 Filed 6-25-09; 8:45 am]
BILLING CODE 4160-01-S