81 FR 65414 - Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology

OFFICE OF SCIENCE AND TECHNOLOGY POLICY

Federal Register Volume 81, Issue 184 (September 22, 2016)

The purpose of this Notice of Request for Public Comment is to solicit relevant comments that can assist in the finalization of the proposed update to the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) to clarify the current roles and responsibilities of the EPA, FDA, and USDA consistent with the objectives described in the July 2, 2015 Memorandum issued by the Executive Office of the President.

[Federal Register Volume 81, Number 184 (Thursday, September 22, 2016)]
[Notices]
[Pages 65414-65415]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-22802]


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OFFICE OF SCIENCE AND TECHNOLOGY POLICY


Clarifying Current Roles and Responsibilities Described in the 
Coordinated Framework for the Regulation of Biotechnology

AGENCY: National Science and Technology Council, Office of Science and 
Technology Policy.

ACTION: Notice of Request for Public Comment.

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SUMMARY: The purpose of this Notice of Request for Public Comment is to 
solicit relevant comments that can assist in the finalization of the 
proposed update to the Coordinated Framework for the Regulation of 
Biotechnology (Coordinated Framework) to clarify the current roles and 
responsibilities of the EPA, FDA, and USDA consistent with the 
objectives described in the July 2, 2015 Memorandum issued by the 
Executive Office of the President.

DATES: Responses must be received by November 1, 2016 at 5:00 p.m. EDT 
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 
unchanged.
     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. 
Responses must be received by the deadline to be considered.
    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; 
Request for Public Comment.
    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 Request for Public Comment will not be returned. 
The National Science and Technology Council is under no obligation to 
acknowledge receipt of the information received. No requests for a bid 
package or solicitation will be accepted; no bid package or 
solicitation exists. This Request for Public Comment is issued solely 
for information 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; Melissa M. Goldstein, 
[email protected]; Online: https://www.whitehouse.gov/webform/contact-emerging-technologies-interagency-policy-coordinating-committee-national-science-and.

SUPPLEMENTARY INFORMATION:

Background Information

    While the current Federal regulatory system for biotechnology 
products effectively protects health and the environment, advances in 
science and technology have altered the product landscape in recent 
years. In addition, the complexity of the current regulatory system can 
make it difficult for the public to understand how the safety of 
biotechnology products is evaluated and create challenges for small and 
mid-sized businesses navigating the regulatory process for these 
products.
    To address these challenges, on July 2, 2015, the Executive Office 
of the President (EOP) issued a memorandum (July 2015 EOP Memorandum, 
Ref. 1) directing the primary agencies that regulate the products of 
biotechnology--the U.S. Environmental Protection Agency (EPA), the U.S. 
Food and Drug Administration (FDA), and the U.S. Department of 
Agriculture (USDA)--to accomplish three tasks: (1) Update the 
Coordinated Framework for the Regulation of Biotechnology (51 FR 23302; 
June 26, 1986) (Ref. 2) by clarifying current roles and 
responsibilities; (2) Develop a long-term strategy to ensure that the 
Federal biotechnology regulatory system is equipped to efficiently 
assess the risks, if any, of the future products of biotechnology; and 
(3) Commission an expert analysis of the future landscape of 
biotechnology products.
    In directing the agencies to accomplish these three tasks, the 
Administration's goal is to ensure public confidence in the regulatory 
system and improve the transparency, predictability, coordination, and, 
ultimately, efficiency of the biotechnology regulatory system.
    To accomplish the tasks described in the July 2015 EOP Memorandum, 
EPA, FDA, USDA and EOP formed a Biotechnology Working Group, which was 
established under the auspices of the Emerging Technologies Interagency 
Policy Coordination (ETIPC) Committee. Members of this working group 
spent the last 14 months performing a detailed analysis of the Federal 
system for regulation of biotechnology products, including by reviewing 
more than 900 comments that were submitted in response to a Request for 
Information that was posted last fall and interacting with members of 
the public at three public meetings that were held in different regions 
of the country. These meetings included presentations describing 
agency-specific oversight of

[[Page 65415]]

biotechnology products, discussions of case studies that provided 
concrete examples of how various biotechnology products might navigate 
the Federal biotechnology regulatory system, and breakout listening 
sessions with participants and representatives from the agencies. 
Transcripts of the public meetings, including comments received at the 
meetings, were placed in the public docket, along with all of the 
comments received in response to the Request for Information and a 
summary of individual input received during the breakout listening 
sessions.
    On September 16, 2016, the Administration released the proposed 
update to the Coordinated Framework, available at: https://www.whitehouse.gov/sites/default/files/microsites/ostp/biotech_coordinated_framework.pdf, and a National Strategy for 
Modernizing the Regulatory System for Biotechnology Products, available 
at: https://www.whitehouse.gov/sites/default/files/microsites/ostp/biotech_national_strategy.pdf, consistent with the first and second 
activities identified in the July 2015 EOP Memorandum. In addition, 
EPA, FDA, and USDA have commissioned an independent study by the 
National Academy of Sciences to satisfy the third of the three 
activities specified above
    With respect to the proposed update to the Coordinated Framework, 
the July 2015 EOP Memorandum listed four areas to be addressed:
    1. Clarify which biotechnology product areas are within the 
authority and responsibility of each agency;
    2. Clarify the roles each agency plays for different product areas, 
particularly for those products that fall within the scope of multiple 
agencies, and how those roles relate to each other in the course of a 
regulatory assessment;
    3. Clarify a standard mechanism for communication and, as 
appropriate, coordination among agencies, while they perform their 
respective regulatory functions, and for identifying agency designees 
responsible for this coordination function; and
    4. Clarify the mechanism and timeline for regularly reviewing, and 
updating as appropriate, the Coordinated Framework to minimize delays, 
support innovation, protect health and the environment and promote the 
public trust in the regulatory systems for biotechnology products.
    To accomplish the first task, the proposed update to the 
Coordinated Framework describes the types of biotechnology product 
areas regulated by the various components within each primary 
regulatory agency (i.e., EPA, FDA, or USDA), organized by agency (see 
Section D of the proposed update to the Coordinated Framework). To 
accomplish the second task, the proposed update to the Coordinated 
Framework provides a table of responsibilities, organized by 
biotechnology product area (see Table 2. of the proposed update to the 
Coordinated Framework). The table describes the offices within each 
agency or agencies that may have regulatory responsibility for a given 
biotechnology product area, as well as relevant coordination across the 
agencies. To accomplish the third task, the proposed update to the 
Coordinated Framework describes memoranda of understanding (MOU) among 
the agencies, and the types of products and information that are 
covered within the scope of each MOU (see Section D 2 of the proposed 
update to the Coordinated Framework). To accomplish the final task, 
Section E of the proposed update to the Coordinated Framework discusses 
provisions for future review of the Coordinated Framework.

Information Requested

    The National Science and Technology Council requests relevant 
comments that can inform the finalization of the proposed update to the 
Coordinated Framework by clarifying the current roles and 
responsibilities of the EPA, FDA, and USDA consistent with the 
objectives described in the July 2, 2015 EOP Memorandum.
    Respondents are welcome to address one or more of the following 
questions in regard to the proposed update to the Coordinated 
Framework. Respondents are asked to identify which question(s) they are 
addressing.
    1. What additional clarification could be provided regarding which 
biotechnology product areas are within the statutory authority and 
responsibility of each agency?
    2. What additional clarification could be provided regarding the 
roles that each agency plays for different biotechnology product areas, 
particularly for those product areas that fall within the 
responsibility of multiple agencies, and how those roles relate to each 
other in the course of a regulatory assessment?
    3. What additional clarification could be provided regarding 
communication and, as appropriate, coordination among agencies, while 
they perform their respective regulatory functions, and for identifying 
agency designees responsible for this coordination function?
    4. What additional clarification could be provided regarding the 
mechanism and timeline for regularly reviewing, and updating as 
appropriate, the Coordinated Framework to minimize delays, support 
innovation, protect health and the environment and promote the public 
trust in the regulatory systems for biotechnology products?

References

    These references are available electronically at http://www.regulations.gov. We have verified the Web site addresses, but we 
are not responsible for any subsequent changes to Web sites after this 
document publishes in the Federal Register.

1. Executive Office of the President. Office of Science and 
Technology Policy, Office of Management and Budget, United States 
Trade Representative, and Council on Environmental Quality. 
Modernizing the Regulatory System for Biotechnology Products, July 
2, 2015. Available online at: https://www.whitehouse.gov/sites/default/files/microsites/ostp/modernizing_the_reg_system_for_biotech_products_memo_final.pdf.
2. Executive Office of the President. Office of Science and 
Technology Policy. Coordinated Framework for Regulation of 
Biotechnology. 51 FR 23302, June 26, 1986. Available online at: 
http://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf.


Ted Wackler,
Deputy Chief of Staff and Assistant Director.
[FR Doc. 2016-22802 Filed 9-21-16; 8:45 am]
 BILLING CODE 3270-F6-P