81 FR 17426 - Modernizing the Regulatory System for Biotechnology Products; Notice of Third Public Meeting

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 81, Issue 60 (March 29, 2016)

Under the auspices of the National Science and Technology Council, USDA, along with the White House Office of Science and Technology Policy, the Environmental Protection Agency and the Food and Drug Administration (FDA) are holding the third public meeting related to the memorandum entitled, ``Modernizing the Regulatory System for Biotechnology Products,'' issued by the Executive Office of the President in July 2015. The purpose of the third 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 60 (Tuesday, March 29, 2016)]
[Notices]
[Page 17426]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-07015]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2016-0024]


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

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: Under the auspices of the National Science and Technology 
Council, USDA, along with the White House Office of Science and 
Technology Policy, the Environmental Protection Agency and the Food and 
Drug Administration (FDA) are holding the third public meeting related 
to the memorandum entitled, ``Modernizing the Regulatory System for 
Biotechnology Products,'' issued by the Executive Office of the 
President in July 2015. The purpose of the third 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 30, 2016, from 9:30 a.m. to 
1:30 p.m. PDT.
    To request accommodation of a disability, please immediately 
contact the person listed under FOR FURTHER INFORMATION CONTACT to give 
USDA as much time as possible to process your request.

ADDRESSES: The meeting will be held at the University of California, 
Davis Conference Center, Davis, CA 95616.

FOR FURTHER INFORMATION CONTACT: For general questions about the 
meeting, contact Mr. Sidney W. Abel, Assistant Deputy Administrator, 
Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, 
Riverdale, MD 20737-1236; (301) 851-3896. 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, 
the Environmental Protection Agency, Food and Drug Administration 
(FDA), United States Department of Agriculture (USDA) and the White 
House Office of Science and Technology Policy (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.
    A second public meeting was held on March 9, 2016, in Dallas, TX. 
Transcripts and materials from this meeting can be found in the docket 
[FDA-2015-N-3403] on www.regulations.gov.
    On February 1, 2016, we announced the date and location for the 
third public engagement session: https://www.aphis.usda.gov/biotechnology/modernizing-framework.
    The third public meeting will be held on March 30, 2016, at the 
University of California's Davis Conference Center in Davis, CA.
    There are two draft documents available that will be the basis for 
discussion at the March 30 meeting: A document with eight case studies 
of hypothetical biotechnology products, and a table of oversight 
authorities related to biotechnology products. These documents can be 
found in the docket [FDA-2015-N-3403] on www.regulations.gov and on the 
USDA Web site at https://www.aphis.usda.gov/biotechnology/modernizing-framework, along with the final meeting agenda as soon as it is 
available.

II. How can I participate in the March 30th meeting?

    There will be several opportunities for questions and answers to 
clarify the information presented during the case studies. The agenda 
for this meeting provides time for general public comments from those 
attending the meeting in person. Those planning to provide comment are 
asked to indicate their desire to comment when they register on USDA's 
Web site prior to the public meeting. Public comments made at this 
meeting will be submitted to the docket as part of the official meeting 
transcript.
    To participate in person or view the webinar, please register in 
advance online at https://www.regonline.com/builder/site/default.aspx?EventID=1824027. 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] on 
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 and accessible in the docket as soon they are 
available. Additionally, we will live webcast and record the public 
meeting. Once the recorded video is available, it will be accessible on 
USDA's YouTube channel.
    Transcripts and meeting materials may also be viewed in our reading 
room, which is located in Room 1141 of the USDA South Building, 14th 
Street and Independence Avenue SW., Washington, DC. Normal reading room 
hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. 
To be sure someone is there to help you, please call (202) 799-7039 
before coming.

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.3.

    Done in Washington, DC, this 23rd day of March 2016.
Michael C. Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-07015 Filed 3-28-16; 8:45 am]
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