Notice2022-27599
Request for Information; Identifying Ambiguities, Gaps, Inefficiencies, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 20, 2022
Issuing agencies
Science and Technology Policy Office
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 243 (Tuesday, December 20, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 243 (Tuesday, December 20, 2022)]
[Notices]
[Pages 77900-77901]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27599]
=======================================================================
-----------------------------------------------------------------------
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).
-----------------------------------------------------------------------
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):
<bullet> Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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.
<bullet> 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
<bullet> 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
<a href="https://www.zoomgov.com/webinar/register/WN_IhbckX4VTiacK0AsyiikKQ">https://www.zoomgov.com/webinar/register/WN_IhbckX4VTiacK0AsyiikKQ</a>. If
you are interested in additional listening sessions, please contact
Dominique Carter at <a href="/cdn-cgi/l/email-protection#62000b0d1607010a4f100705170e03160b0d0c220d1116124c070d124c050d14"><span class="__cf_email__" data-cfemail="9efcf7f1eafbfdf6b3ecfbf9ebf2ffeaf7f1f0def1edeaeeb0fbf1eeb0f9f1e8">[email protected]</span></a>. Summaries of the
comments offered during the public listening session and any small
listening sessions will be posted to the docket on <a href="http://regulations.gov">regulations.gov</a>.
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, <a href="/cdn-cgi/l/email-protection#5133383e253432397c233436243d3025383e3f113e2225217f343e217f363e27"><span class="__cf_email__" data-cfemail="6a0803051e0f090247180f0d1f060b1e0305042a05191e1a440f051a440d051c">[email protected]</span></a>, tel: 202-
456-4444.
EPA: Mike Mendelsohn, <a href="/cdn-cgi/l/email-protection#94d9f1faf0f1f8e7fbfcfabad9fdfff1d4f1e4f5baf3fbe2"><span class="__cf_email__" data-cfemail="09446c676d6c657a666167274460626c496c7968276e667f">[email protected]</span></a>.
FDA: Eric Flamm, <a href="/cdn-cgi/l/email-protection#4c093e252f620a202d21210c2a282d6224243f622b233a"><span class="__cf_email__" data-cfemail="4500372c266b0329242828052321246b2d2d366b222a33">[email protected]</span></a>.
USDA: Alan Pearson, <a href="/cdn-cgi/l/email-protection#95f4f9f4fbbbe5f0f4e7e6fafbd5e0e6f1f4bbf2fae3"><span class="__cf_email__" data-cfemail="d7b6bbb6b9f9a7b2b6a5a4b8b997a2a4b3b6f9b0b8a1">[email protected]</span></a>.
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 <a href="https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home/">https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home/</a>.
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:
<bullet> 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;
<bullet> provide plain-language information on the regulatory
roles, responsibilities, and processes of each agency;
<bullet> 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]
BILLING CODE 3270-F1-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 20, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.