2016-04583. Modernizing the Regulatory System for Biotechnology Products; Notice of Second Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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: [phone]; email address: [e-mail]. 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.

Dated: February 24, 2016.

Mark A. Hartman,

Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.