AGENCY: National Science and Technology Council, Science and Technology
ACTION: Notice of request for information.
SUMMARY: On July 2, 2015, the Executive Office of the President (EOP)
issued a memorandum (Ref. 1) directing the primary agencies that
regulate the products of biotechnology--the U.S. Environmental
Protection Agency (EPA), the Food and Drug Administration (FDA), and
the U.S. Department of Agriculture (USDA)--to update the Coordinated
Framework for the Regulation of Biotechnology (51 FR 23302; June 26,
1986) (Ref. 2), develop a long-term strategy to ensure that the Federal
biotechnology regulatory system is prepared for the future products of
biotechnology, and commission an expert analysis of the future
landscape of biotechnology products to support this effort. The
memorandum's objectives are to ensure public confidence in the
regulatory system and to prevent unnecessary barriers to future
innovation and competitiveness by improving the transparency,
coordination, predictability, and efficiency of the regulation of
biotechnology products while continuing to protect health and the
The purpose of this Request for Information (RFI) is to solicit
relevant data and information, including case studies, that can assist
in the development of the proposed update to the Coordinated Framework
for the Regulation of Biotechnology (CF) to clarify the current roles
and responsibilities of the EPA, FDA, and USDA and the development of a
long-term strategy consistent with the objectives described in the July
2, 2015 EOP memorandum. In addition to this RFI, the update to the CF
will undergo public comment before it is finalized.
DATES: Responses must be received by November 13, 2015 at 5:00 p.m. EST
to be considered.
ADDRESSES: You may submit information by either of the following
methods (electronic is strongly preferred):
Federal eRulemaking Portal: http://www.regulations.gov.
Docket No. FDA-2015-N-3403. Follow the instructions for submitting
information. Information submitted electronically, including
attachments, to http://www.regulations.gov will be posted to the docket
Mail: National Science and Technology Council: Emerging
Technologies Interagency Policy Coordination Committee, Office of
Science and Technology Policy, 1650 Pennsylvania Avenue NW.,
Washington, DC 20504. If submitting a response by mail, please allow
sufficient time for mail processing. Written/paper information,
including attachments, will be posted to the docket unchanged.
Instructions: All submissions received must include Docket No. FDA-
2015-N-3403 for Clarifying Current Roles and Responsibilities Described
in the Coordinated Framework for the Regulation of Biotechnology and
Developing a Long-Term Strategy for the Regulation of the Products of
Biotechnology; Request for Information.
Disclaimer: All information received will be placed in the docket
and will be publicly viewable at http://www.regulations.gov. Responses
must be unclassified and should not contain any information that might
be considered proprietary, confidential, or personally identifying
(such as home address or social security number).
Responses to this RFI will not be returned. The National Science
and Technology Council is under no obligation to acknowledge receipt of
the information received, or provide feedback to respondents with
respect to any information submitted under this RFI. No requests for a
bid package or solicitation will be accepted; no bid package or
solicitation exists. This RFI is issued solely for information and
planning purposes and does not constitute a solicitation.
FOR FURTHER INFORMATION CONTACT: 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, Phone:
202-456-4444, Online: https://www.whitehouse.gov/webform/contact-emerging-technologies-interagency-policy-coordinating-committee-national-science-and