81 FR 10858 - Modernizing the Regulatory System for Biotechnology Products; Notice of Second Public Meeting

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 41 (March 2, 2016)

Under the auspices of the National Science and Technology Council, EPA, along with the Office of Science and Technology Policy (OSTP), the Food and Drug Administration (FDA), and the United States Department of Agriculture (USDA) are holding a second public meeting related to the memorandum entitled, ``Modernizing the Regulatory System for Biotechnology Products,'' issued by the Executive Office of the President (EOP) in July 2015. The purpose of the second public meeting is to illustrate current federal roles and responsibilities regarding biotechnology products. The docket, FDA-2015-N-3403, established by FDA prior to the first public meeting will continue to be used for this interagency effort.

[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Pages 10858-10859]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04583]


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ENVIRONMENTAL PROTECTION AGENCY

[FDA-2015-N-3403; FRL-9943-08]


Modernizing the Regulatory System for Biotechnology Products; 
Notice of Second Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Under the auspices of the National Science and Technology 
Council, EPA, along with the Office of Science and Technology Policy 
(OSTP), the Food and Drug Administration (FDA), and the United States 
Department of Agriculture (USDA) are holding a second public meeting 
related to the memorandum entitled, ``Modernizing the Regulatory System 
for Biotechnology Products,'' issued by the Executive Office of the 
President (EOP) in July 2015. The purpose of the second public meeting 
is to illustrate current federal roles and responsibilities regarding 
biotechnology products. The docket, FDA-2015-N-3403, established by FDA 
prior to the first public meeting will continue to be used for this 
interagency effort.

DATES: The meeting will be held on March 9, 2016, from 9:30 a.m. to 
1:00 p.m.
    To request accommodation of a disability, please immediately 
contact the person listed under FOR FURTHER INFORMATON CONTACT to give 
EPA as much time as possible to process your request.

ADDRESSES: The meeting will be held at the EPA Region 6 Office at 1445 
Ross Avenue, Dallas, Texas 75202-2750.

FOR FURTHER INFORMATION CONTACT: For general questions about the 
meeting, contact Robert McNally, Biopesticides and Pollution Prevention 
Division (7511P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
[email protected]. For questions about the memorandum entitled, 
``Modernizing the Regulatory System for Biotechnology Products,'' or 
related activities described in that memorandum, contact the National 
Science and Technology Council: Emerging Technologies Interagency 
Policy Coordination Committee, Office of Science and Technology Policy, 
Executive Office of the President, Eisenhower Executive Office 
Building, 1650 Pennsylvania Ave. Washington, DC 20504, 202-456-4444, 
online: https://www.whitehouse.gov/webform/contact-emerging-technologies-interagency-policy-coordinating-committee-national-science-and.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the auspices of the National Science and Technology Council, 
EPA, FDA, USDA and OSTP (collectively referred to as ``we'' in this 
Federal Register document), held a public meeting on October 30, 2015, 
to discuss the Executive Office of the President (EOP) memorandum 
entitled, ``Modernizing the Regulatory System for Biotechnology 
Products,'' that was issued in July 2015. The purpose of the October 
2015 meeting was to inform the public about the activities described in 
the July 2015 memorandum; invite oral comments from interested parties; 
and provide information about how to submit written comments, data, or 
other information to the docket. The October meeting was the first of 
three public engagement sessions on this topic.
    On February 1, 2016, we announced the dates and locations for the 
second and third public engagement sessions: (1) https://wcms.epa.gov/pesticides/save-date-march-9-30-2016-public-meetings-updating-coordinated-framework-regulation; (2) http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm463783.htm; and (3) https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/sa_stakeholder_meetings/cf_meeting.
    The second public meeting will be held on March 9, 2016, from 9:30 
a.m. to 1:00 p.m. at EPA's Region 6 Office in Dallas, Texas. The second 
public meeting will be used to illustrate current federal roles and 
responsibilities regarding biotechnology products. The final meeting 
agenda will be placed in the docket [FDA-2015-N-3403] as soon as it is 
available.
    The third public meeting will be held on March 30, 2016, at the 
University of California's Davis Conference Center in Davis, California 
and information about that meeting, including an agenda and information 
regarding how to register will be placed in the docket and on the USDA 
Web site prior to the meeting.

II. How can I participate in the March 9th meeting?

    To participate in person or by webinar via Adobe Connect, please 
register online at http://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/modernizing-regulatory-system-biotechnology-products.
    Those registered will receive detailed instructions with their 
confirmations that explain how to access the meeting via webinar or in 
person.

III. Meeting Materials, Transcripts and Recorded Video

    Any additional information and data submitted voluntarily to us 
will become part of the administrative record for this activity and 
will be accessible to the public in the docket [FDA-2015-N-3403] at 
http://www.regulations.gov. The transcript of the proceedings from the 
public meeting will become part of the administrative record for this 
activity and will also be included in the docket. Please be advised 
that as soon as a transcript is available, it will be accessible in the 
docket at http://www.regulations.gov.
    Transcripts and meeting materials may also be viewed at the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will be 
available in either hardcopy or on CD-ROM, after submission of a 
Freedom of Information request. Written requests are to be sent to the 
FDA Division of Freedom of Information, 5630 Fishers Lane, Rm. 1035, 
Rockville, MD 20857. Additionally, we will live webcast and record the 
public meeting. Once the recorded video is available, it will be 
accessible on EPA's YouTube Channel.


[[Page 10859]]


    Dated: February 24, 2016.
Mark A. Hartman,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.
[FR Doc. 2016-04583 Filed 3-1-16; 8:45 am]
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