[Federal Register Volume 87, Number 243 (Tuesday, December 20, 2022)]
[Notices]
[Pages 77900-77901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27599]


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OFFICE OF SCIENCE AND TECHNOLOGY POLICY


Request for Information; Identifying Ambiguities, Gaps, 
Inefficiencies, and Uncertainties in the Coordinated Framework for the 
Regulation of Biotechnology

AGENCY: Office of Science and Technology Policy (OSTP).

ACTION: Notice of request for information (RFI).

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SUMMARY: The National Biotech and Biomanufacturing Initiative (NBBI) 
identified biotechnology regulation clarity and efficiency as a 
priority of the Administration. Thus, the White House Office of Science 
and Technology Policy (OSTP)--on behalf of 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)--requests relevant data and 
information, including case studies, that may assist in identifying any 
regulatory ambiguities, gaps, inefficiencies, or uncertainties in the 
Coordinated Framework for the Regulation of Biotechnology, particularly 
with regard to new and emerging biotechnology products. The information 
provided will inform regulatory agency efforts to improve the clarity 
and efficiency of the regulatory processes for biotechnology products.

DATES: Interested persons and organizations are invited to submit 
comments on or before 5 p.m. ET February 3, 2023.

ADDRESSES: USDA is managing this docket and is listed as the primary 
addressee below. All three agencies and OSTP will be considering all 
submitted comments as part of their efforts to identify regulatory 
ambiguities, gaps, or uncertainties in the Coordinated Framework.
    You may submit information by any of the following methods (Due to 
time constraints, the eRulemaking Portal is strongly preferred):
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Enter ``APHIS-2022-0076'' in the Search field. 
Select the Documents tab, then select the Comment button in the list of 
documents and follow the instructions to submit your comment.
     Postal Mail: Send your comment to the following address. 
Please include Docket No. APHIS-2022-0076 in the subject line.

Animal and Plant Health Inspection Service, US Department of 
Agriculture, 4700 River Road, Riverdale, MD 20737, Attn: Alan Pearson

     Listening Sessions: The regulatory agencies and OSTP will 
host a virtual public listening session on January 12, 2023. If you are 
interested in registering for the virtual listening session, go to 
https://www.zoomgov.com/webinar/register/WN_IhbckX4VTiacK0AsyiikKQ. If 
you are interested in additional listening sessions, please contact 
Dominique Carter at [email protected]. Summaries of the 
comments offered during the public listening session and any small 
listening sessions will be posted to the docket on regulations.gov.
    Response to this request for information (RFI) is voluntary. Each 
individual or institution is requested to submit only one response. 
Responses should include the name of the person(s) or organization(s) 
filing the response. Please identify your answers by referring to a 
specific question number within the response.
    Comments submitted in response to this notice are subject to the 
Freedom of Information Act (FOIA). Responses to this RFI may be posted 
without change online. No proprietary information, copyrighted 
information, or personally identifiable information should be submitted 
in response to this RFI.
    This RFI is issued solely for information and planning purposes and 
does not constitute a solicitation. There will be no response to 
individual submissions. Please note that the United States Government 
will not pay for response preparation, or for the use of any 
information contained in a response. If submitting a response by mail, 
please allow sufficient time for mail processing and include the docket 
number and title.

FOR FURTHER INFORMATION CONTACT: 
    OSTP: Dominique Carter, [email protected], tel: 202-
456-4444.
    EPA: Mike Mendelsohn, [email protected].
    FDA: Eric Flamm, [email protected].
    USDA: Alan Pearson, [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 77901]]

Background Information

    In 1986, OSTP issued the Coordinated Framework for the Regulation 
of Biotechnology (51 FR 23302), which outlined a comprehensive Federal 
regulatory policy for ensuring the safety of biotechnology products. 
The Coordinated Framework sought to achieve a balance between 
regulation adequate to ensure the protection of health and the 
environment while maintaining sufficient regulatory flexibility to 
avoid impeding innovation.
    In 1992, OSTP issued an update to the Coordinated Framework that 
set forth a risk-based, scientifically sound basis for the oversight of 
activities that introduce biotechnology products into the environment 
(57 FR 6753). The update affirmed that Federal oversight should focus 
on the characteristics of the product, the environment into which it is 
being introduced, and the intended use of the product, rather than the 
process by which the product is created.
    In 2015, the Executive Office of the President (EOP) issued a 
memorandum directing EPA, FDA, and USDA to update the Coordinated 
Framework. The Federal government subsequently published a National 
Strategy for Modernizing the Regulatory System for Biotechnology in 
2016; and in 2017, OSTP issued another update to the Coordinated 
Framework. This 2017 update clarifies current agency roles and 
responsibilities for the regulation of biotechnology products. It 
provides a table of responsibilities that lists the offices within each 
agency or agencies that may have regulatory responsibility for a given 
biotechnology product category, and relevant coordination across the 
agencies. In addition, it describes memoranda of understanding (MOUs) 
among the agencies and the types of products and information that are 
covered within the scope of each MOU. In 2019, E.O. 13874 recognized 
that advances in biotechnology have the potential to revolutionize 
agriculture, enhance rural prosperity, and improve the quality of 
American lives. The E.O. ordered additional steps to be taken to 
further modernize the regulatory framework.
    For details on the current roles and responsibilities of agencies 
under the Coordinated Framework for the Regulation of Biotechnology, 
refer to the Unified website for Biotechnology Regulation https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home/.
    On September 12, 2022, President Biden issued Executive Order 
(E.O.) 14081, ``Advancing Biomanufacturing and Biotechnology Innovation 
for a Sustainable, Safe, and Secure Bioeconomy,'' with the goal of 
accelerating biotechnology innovation and growing America's bioeconomy 
across multiple sectors, including health, agriculture, and energy. 
Among other objectives, E.O. 14081 aims to support the safe use of 
biotechnology by clarifying and streamlining regulations in service of 
a science- and risk-based, predictable, efficient, and transparent 
regulatory system to support the safe use of products of biotechnology. 
E.O. 14081 directs the EPA, FDA, and USDA to:
     identify any regulatory ambiguities, gaps, or 
uncertainties in the Coordinated Framework for the Regulation of 
Biotechnology, through engaging with developers and stakeholders and 
through horizon scanning for novel biotechnology products;
     provide plain-language information on the regulatory 
roles, responsibilities, and processes of each agency;
     provide a plan with processes and timelines to implement 
regulatory reform; and build upon the Unified website for Biotechnology 
Regulation.
    As noted in the Executive Order, ``biotechnology means technology 
that applies to and/or is enabled by life sciences innovation or 
product development.'' Biotechnology products include, for example, 
organisms (including plants, animals, and microbes) developed through 
genetic engineering or the targeted or in vitro manipulation of genetic 
information, some products derived from such organisms, as well as 
products produced via cell-free synthesis, as determined by existing 
statutes and regulations.

Questions

    Respondents are encouraged to provide relevant data or information, 
including case studies, regarding regulatory ambiguities, gaps, or 
uncertainties in the Coordinated Framework, and regarding new and 
emerging biotechnology products. Respondents need not reply to all 
questions listed. Please identify your answers as responses to a 
specific question.
    1. Describe any ambiguities, gaps, inefficiencies, or uncertainties 
regarding statutory authorities and/or agency roles, responsibilities, 
or processes for different biotechnology product types, particularly 
for product types within the responsibility of multiple agencies.
    a. Describe the impact, including economic impact, of these 
ambiguities, gaps, inefficiencies or uncertainties.
    2. Provide any relevant data or information, including case 
studies, that could inform improvement in the clarity or efficiency 
(including the predictability, transparency, and coordination) of the 
regulatory system and processes for biotechnology products.
    3. Describe any specific topics the agencies should address in 
plain language on the regulatory roles, responsibilities, and processes 
of the agencies.
    4. Describe any specific issues the agencies should consider in 
developing a plan to implement regulatory reform, including any updated 
or new regulations or guidance documents.
    5. Describe any new or emerging biotechnology products (e.g., 
microbial amendments to promote plant growth; food plants expressing 
non-food substances or allergens from non-plant sources) that, based on 
lessons learned from past experiences or other information, the 
agencies should pay particular attention to in their evaluation of 
ambiguities, gaps, or uncertainties regarding statutory authorities 
and/or agency roles or processes.
    6. Describe any new or emerging categories of biotechnology 
products on the horizon that the regulatory system and processes for 
biotechnology products should be preparing to address. Describe any 
specific recommendations for regulating these new or emerging 
categories of biotechnology products to guide agency preparations.
    7. What is the highest priority issue for the agencies to address 
in the short term (i.e., within the next year) and in the long term?

    Dated: December 15, 2022.
Rachel Wallace,
Deputy General Counsel.
[FR Doc. 2022-27599 Filed 12-19-22; 8:45 am]
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