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)
Animal and Plant Health Inspection Service
Federal Register Volume 81, Issue 60 (March 29, 2016)
| Page Range | 17426-17426 | |
| FR Document | 2016-07015 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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] BILLING CODE 3410-34-P
![17426 Federal Register / Vol. 81, No. 60 / Tuesday, March 29, 2016 / Notices
Total Burden Hours: 28. Policy Coordination Committee, Office II. How can I participate in the March
of Science and Technology Policy, 30th meeting?
Ruth Brown,
Executive Office of the President,
Departmental Information Collection There will be several opportunities for
Eisenhower Executive Office Building,
Clearance Officer. questions and answers to clarify the
1650 Pennsylvania Ave., Washington,
[FR Doc. 2016–07003 Filed 3–28–16; 8:45 am] information presented during the case
DC 20504; (202) 456–4444; online:
BILLING CODE 3410–34–P studies. The agenda for this meeting
https://www.whitehouse.gov/webform/
contact-emerging-technologies- provides time for general public
interagency-policy-coordinating- comments from those attending the
DEPARTMENT OF AGRICULTURE meeting in person. Those planning to
committee-national-science-and.
Animal and Plant Health Inspection provide comment are asked to indicate
SUPPLEMENTARY INFORMATION:
Service their desire to comment when they
I. Background register on USDA’s Web site prior to the
[Docket No. APHIS–2016–0024] public meeting. Public comments made
Under the auspices of the National at this meeting will be submitted to the
Modernizing the Regulatory System for Science and Technology Council, the docket as part of the official meeting
Biotechnology Products; Notice of Environmental Protection Agency, Food
Third Public Meeting transcript.
and Drug Administration (FDA), United
To participate in person or view the
AGENCY: Animal and Plant Health States Department of Agriculture
(USDA) and the White House Office of webinar, please register in advance
Inspection Service, USDA. online at https://www.regonline.com/
ACTION: Notice. Science and Technology Policy
(collectively referred to as ‘‘we’’ in this builder/site/default.aspx?EventID=
SUMMARY: Under the auspices of the Federal Register document), held a 1824027. Those registered will receive
National Science and Technology public meeting on October 30, 2015, to detailed instructions with their
Council, USDA, along with the White discuss the Executive Office of the confirmations that explain how to
House Office of Science and Technology President (EOP) memorandum entitled, access the meeting via webinar or in
Policy, the Environmental Protection ‘‘Modernizing the Regulatory System for person.
Agency and the Food and Drug Biotechnology Products,’’ that was III. Meeting Materials, Transcripts and
Administration (FDA) are holding the issued in July 2015. The purpose of the Recorded Video
third public meeting related to the October 2015 meeting was to inform the
memorandum entitled, ‘‘Modernizing public about the activities described in Any additional information and data
the Regulatory System for the July 2015 memorandum, invite oral submitted voluntarily to us will become
Biotechnology Products,’’ issued by the comments from interested parties, and part of the administrative record for this
Executive Office of the President in July provide information about how to activity and will be accessible to the
2015. The purpose of the third public submit written comments, data, or other public in the docket [FDA–2015–N–
meeting is to illustrate current Federal information to the docket. The October 3403] on www.regulations.gov. The
roles and responsibilities regarding meeting was the first of three public transcript of the proceedings from the
biotechnology products. The docket, engagement sessions on this topic. public meeting will become part of the
FDA–2015–N–3403, established by FDA A second public meeting was held on administrative record for this activity
prior to the first public meeting, will March 9, 2016, in Dallas, TX. and will also be included and accessible
continue to be used for this interagency Transcripts and materials from this in the docket as soon they are available.
effort. meeting can be found in the docket Additionally, we will live webcast and
DATES: The meeting will be held on [FDA–2015–N–3403] on record the public meeting. Once the
March 30, 2016, from 9:30 a.m. to 1:30 www.regulations.gov. recorded video is available, it will be
p.m. PDT. accessible on USDA’s YouTube channel.
To request accommodation of a On February 1, 2016, we announced
disability, please immediately contact the date and location for the third Transcripts and meeting materials
the person listed under FOR FURTHER public engagement session: https:// may also be viewed in our reading
INFORMATION CONTACT to give USDA as
www.aphis.usda.gov/biotechnology/ room, which is located in Room 1141 of
much time as possible to process your modernizing-framework. the USDA South Building, 14th Street
request. The third public meeting will be held and Independence Avenue SW.,
ADDRESSES: The meeting will be held at on March 30, 2016, at the University of Washington, DC. Normal reading room
the University of California, Davis California’s Davis Conference Center in hours are 8 a.m. to 4:30 p.m., Monday
Conference Center, Davis, CA 95616. Davis, CA. through Friday, except holidays. To be
FOR FURTHER INFORMATION CONTACT: For There are two draft documents sure someone is there to help you,
general questions about the meeting, available that will be the basis for please call (202) 799–7039 before
contact Mr. Sidney W. Abel, Assistant discussion at the March 30 meeting: A coming.
Deputy Administrator, Biotechnology document with eight case studies of Authority: 7 U.S.C. 7701–7772 and 7781–
Regulatory Services, APHIS, 4700 River hypothetical biotechnology products, 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
Road, Unit 147, Riverdale, MD 20737– and a table of oversight authorities 371.3.
mstockstill on DSK4VPTVN1PROD with NOTICES
1236; (301) 851–3896. For questions related to biotechnology products.
Done in Washington, DC, this 23rd day of
about the memorandum entitled, These documents can be found in the March 2016.
‘‘Modernizing the Regulatory System for docket [FDA–2015–N–3403] on
Biotechnology Products,’’ or related www.regulations.gov and on the USDA Michael C. Gregoire,
activities described in that Web site at https://www.aphis.usda.gov/ Acting Administrator, Animal and Plant
memorandum, contact the National biotechnology/modernizing-framework, Health Inspection Service.
Science and Technology Council: along with the final meeting agenda as [FR Doc. 2016–07015 Filed 3–28–16; 8:45 am]
Emerging Technologies Interagency soon as it is available. BILLING CODE 3410–34–P
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Document Created: 2016-03-30 08:29:39
Document Modified: 2016-03-30 08:29:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The meeting will be held on March 30, 2016, from 9:30 a.m. to 1:30 p.m. PDT. | |
| 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. | |
| FR Citation | 81 FR 17426 |
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