80_FR_60607 80 FR 60414 - 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

80 FR 60414 - 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

SCIENCE AND TECHNOLOGY POLICY OFFICE

Federal Register Volume 80, Issue 193 (October 6, 2015)

Page Range60414-60416
FR Document2015-25325

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 environment. 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.

Federal Register, Volume 80 Issue 193 (Tuesday, October 6, 2015)
[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60414-60416]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25325]


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SCIENCE AND TECHNOLOGY POLICY OFFICE


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

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

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 
environment.
    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 
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.
    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:

[[Page 60415]]

202-456-4444, Online: https://www.whitehouse.gov/webform/contact-emerging-technologies-interagency-policy-coordinating-committee-national-science-and

SUPPLEMENTARY INFORMATION: 

Background Information

    In 1986, the Office of Science and Technology Policy (OSTP) issued 
the Coordinated Framework for the Regulation of Biotechnology (CF), 
which outlined a comprehensive Federal regulatory policy for ensuring 
the safety of biotechnology products. The CF 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 CF that sets forth a risk-
based, scientifically sound basis for the oversight of activities that 
introduce biotechnology products into the environment (57 FR 6753; 
February 27, 1992) (Ref. 3). 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.
    On July 2, 2015 the Executive Office of the President (EOP) issued 
a memorandum directing the primary Federal agencies that have oversight 
responsibilities for 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 CF 
to clarify the current roles and responsibilities of the agencies that 
regulate the products of biotechnology, develop a long-term strategy to 
ensure that the Federal biotechnology regulatory system is prepared for 
the future products of biotechnology, and commission an independent, 
expert analysis of the future landscape of biotechnology products. 
These efforts will build on the regulatory principles described in the 
CF and the 1992 update to the CF. 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 environment.
    The July 2, 2015 EOP memorandum stated that the update to the CF 
should clarify the current roles and responsibilities of the agencies 
that regulate the products of biotechnology by accomplishing the 
following four objectives:
    (i) Clarifying which biotechnology product areas are within the 
authority and responsibility of each agency;
    (ii) clarifying the roles that each agency plays for different 
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;
    (iii) clarifying 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
    (iv) clarifying the mechanism and timeline for regularly reviewing, 
and updating as appropriate, the CF to minimize delays, support 
innovation, protect health and the environment and promote the public 
trust in the regulatory systems for biotechnology products.
    As noted in the July 2, 2015 EOP memorandum, ``biotechnology 
products'' refers to products developed through genetic engineering or 
the targeted or in vitro manipulation of genetic information of 
organisms, including plants, animals, and microbes. It also covers some 
of the products produced by such plants, animals, and microbes or their 
derived products as determined by existing statutes and regulations. 
Products such as human drugs and medical devices are not the focus of 
the activities described in the memorandum.
    The purpose of this RFI is to solicit relevant data and 
information, including case studies, that can inform the development of 
the proposed update to the CF 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.

Information Requested

    The National Science and Technology Council requests relevant data 
and information, including case studies, that can inform the update to 
the CF by clarifying the current roles and responsibilities of the EPA, 
FDA, and USDA and the development of the long-term strategy consistent 
with the objectives described in the July 2, 2015 EOP memorandum. For 
details on the current roles and responsibilities of these agencies, 
refer to their Web sites.

Relevant FDA Web sites

 http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/
 http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm113605.htm

Relevant EPA Web sites

 http://www.epa.gov/pesticides/biopesticides/regtools/biotech-reg-prod.htm
 http://www.epa.gov/biotech_rule/

Relevant USDA Web sites

     https://www.aphis.usda.gov/wps/portal/aphis/ourfocus/biotechnology

A brief summary of these agencies' current roles follows.
    The FDA regulates products of genetically engineered (GE) organisms 
that fall within FDA's authority under the Federal Food, Drug, and 
Cosmetic (FD&C) Act and other statutes. The FDA is responsible for 
ensuring the safety of all plant-derived human and animal foods, 
including those that are from genetically engineered sources. FDA also 
regulates GE animals under the new animal drug provisions of the FD&C 
Act, and FDA's regulations for new animal drugs. (The actual regulated 
article is the recombinant DNA construct inserted into a specific site 
in the genome of an animal; as a shorthand, the FDA refers to the 
regulation of GE animals.)
    Within USDA, the Animal and Plant Health Inspection Service (APHIS) 
is responsible for protecting agriculture from pests and diseases. 
Under the Plant Protection Act (PPA) and the Animal Health Protection 
Act (AHPA), USDA-APHIS has regulatory oversight over products of modern 
biotechnology that could pose a risk to plant and animal health. The 
AHPA provides authority to prohibit or restrict imports or entry into 
the United States or dissemination of any pest or disease of livestock. 
GE animals and insects would be subject to import or transport 
restrictions if there is a risk to animal health. The PPA, as amended, 
provides authority to regulate the introduction (i.e., importation, 
interstate movement, or release into the environment) of certain GE 
organisms and products. A GE organism is considered a regulated article 
if the donor organism, recipient organism, vector, or vector agent used 
in engineering the organism belongs to one of the taxa listed in the 
regulation and is also considered a plant pest. A GE organism is also 
regulated when APHIS has reason to believe that the GE organism may be 
a plant pest. A GE organism is no longer subject to the

[[Page 60416]]

plant pest provisions of the PPA or to regulatory requirements when 
APHIS determines that it is unlikely to pose a plant pest risk.
    The EPA under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) and the FD&C Act regulates the sale and distribution of all 
pesticides, including those produced through genetic engineering. This 
includes microorganisms, biochemicals isolated from organisms, and 
plant-incorporated protectants (PIPs), a type of pesticide intended to 
be produced and used in living plants. Under the Toxic Substances 
Control Act (TSCA), EPA has oversight responsibilities for a wide range 
of commercial, industrial, and consumer applications of microbial 
biotechnology. New chemicals produced through those microbial 
biotechnology applications are subject to premanufacturing review under 
TSCA.

Questions

    Keeping in mind the principles of the regulation of the products of 
biotechnology as articulated in the CF and the 1992 update to the CF, 
as well as the objectives of the July 2, 2015 EOP memorandum, 
respondents are welcome to address one or more of the following 
questions in regards to the proposed update to the CF and the 
development of the long-term strategy. Respondents are asked to 
indicate to which question responses are targeted.
    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. How can Federal agencies improve their communication to 
consumers, industry, and other stakeholders regarding the authorities, 
practices, and bases for decision-making used to ensure the safety of 
the products of biotechnology?
    4. Are there relevant data and information, including case studies, 
that can inform the update to the CF or the development of the long-
term strategy regarding how to improve the transparency, coordination, 
predictability, and efficiency of the regulatory system for the 
products of biotechnology?
    5. Are there specific issues that should be addressed in the update 
of the CF or in the long-term strategy in order to increase the 
transparency, coordination, predictability, and efficiency of the 
regulatory system for the products of biotechnology?

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
3. Executive Office of the President. Office of Science and 
Technology Policy. Exercise of Federal Oversight Within Scope of 
Statutory Authority: Planned Introductions of Biotechnology Products 
Into the Environment. 57 FR 6753, February 27, 1992. Available 
online at: https://www.whitehouse.gov/sites/default/files/microsites/ostp/57_fed_reg_6753__1992.pdf

Ted Wackler,
Deputy Chief of Staff and Assistant Director.
[FR Doc. 2015-25325 Filed 10-5-15; 8:45 am]
 BILLING CODE 3270-F5-P



                                              60414                        Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices

                                              information before making the comment                     Dated at Rockville, Maryland, this 29th day         RFI, the update to the CF will undergo
                                              submissions available to the public or                  of September 2015.                                    public comment before it is finalized.
                                              entering the comment into ADAMS.                          For the Nuclear Regulatory Commission.              DATES: Responses must be received by
                                                                                                      Tremaine Donnell,                                     November 13, 2015 at 5:00 p.m. EST to
                                              II. Background
                                                                                                      NRC Clearance Officer, Office of Information          be considered.
                                                 Under the provisions of the                          Services.                                             ADDRESSES: You may submit
                                              Paperwork Reduction Act of 1995 (44                     [FR Doc. 2015–25340 Filed 10–5–15; 8:45 am]           information by either of the following
                                              U.S.C. Chapter 35), the NRC recently                    BILLING CODE 7590–01–P                                methods (electronic is strongly
                                              submitted a request for renewal of an
                                                                                                                                                            preferred):
                                              existing collection of information to                                                                            • Federal eRulemaking Portal: http://
                                              OMB for review entitled, 10 CFR part 51                 SCIENCE AND TECHNOLOGY POLICY                         www.regulations.gov. Docket No. FDA–
                                              ‘‘Environmental Protection Regulations                  OFFICE                                                2015–N–3403. Follow the instructions
                                              for Domestic Licensing and Related                                                                            for submitting information. Information
                                              Regulatory Functions.’’ The NRC hereby                  Clarifying Current Roles and                          submitted electronically, including
                                              informs potential respondents that an                   Responsibilities Described in the                     attachments, to http://
                                              agency may not conduct or sponsor, and                  Coordinated Framework for the                         www.regulations.gov will be posted to
                                              that a person is not required to respond                Regulation of Biotechnology and                       the docket unchanged.
                                              to, a collection of information unless it               Developing a Long-Term Strategy for                      • Mail: National Science and
                                              displays a currently valid OMB control                  the Regulation of the Products of                     Technology Council: Emerging
                                              number.                                                 Biotechnology                                         Technologies Interagency Policy
                                                 The NRC published a Federal                                                                                Coordination Committee, Office of
                                              Register notice with a 60-day comment                   AGENCY: National Science and
                                                                                                      Technology Council, Science and                       Science and Technology Policy, 1650
                                              period on this information collection on                                                                      Pennsylvania Avenue NW., Washington,
                                              June 23, 2015 (80 FR 35991).                            Technology Policy Office.
                                                                                                      ACTION: Notice of request for
                                                                                                                                                            DC 20504. If submitting a response by
                                                 1. The title of the information
                                                                                                      information.                                          mail, please allow sufficient time for
                                              collection: 10 CFR part 51
                                                                                                                                                            mail processing. Written/paper
                                              ‘‘Environmental Protection Regulations
                                                                                                      SUMMARY:    On July 2, 2015, the Executive            information, including attachments, will
                                              for Domestic Licensing and Related
                                                                                                      Office of the President (EOP) issued a                be posted to the docket unchanged.
                                              Regulatory Functions.’’                                                                                          Instructions: All submissions received
                                                 2. OMB approval number: 3150–0021.                   memorandum (Ref. 1) directing the
                                                 3. Type of submission: Extension.                    primary agencies that regulate the                    must include Docket No. FDA–2015–N–
                                                 4. The form number if applicable: Not                products of biotechnology—the U.S.                    3403 for Clarifying Current Roles and
                                              applicable.                                             Environmental Protection Agency                       Responsibilities Described in the
                                                 5. How often the collection is required              (EPA), the Food and Drug                              Coordinated Framework for the
                                              or requested: Upon submittal of an                      Administration (FDA), and the U.S.                    Regulation of Biotechnology and
                                              application for a combined license,                     Department of Agriculture (USDA)—to                   Developing a Long-Term Strategy for the
                                              construction permit, operating license,                 update the Coordinated Framework for                  Regulation of the Products of
                                              operating license renewal, early site                   the Regulation of Biotechnology (51 FR                Biotechnology; Request for Information.
                                              permit, design certification,                           23302; June 26, 1986) (Ref. 2), develop                  Disclaimer: All information received
                                              decommissioning or license termination                  a long-term strategy to ensure that the               will be placed in the docket and will be
                                              review, or manufacturing license, or                    Federal biotechnology regulatory system               publicly viewable at http://
                                              upon submittal of a petition for                        is prepared for the future products of                www.regulations.gov. Responses must
                                              rulemaking.                                             biotechnology, and commission an                      be unclassified and should not contain
                                                 6. Who will be required or asked to                  expert analysis of the future landscape               any information that might be
                                              respond: Licensees and applicants                       of biotechnology products to support                  considered proprietary, confidential, or
                                              requesting approvals for actions                        this effort. The memorandum’s                         personally identifying (such as home
                                              proposed in accordance with the                         objectives are to ensure public                       address or social security number).
                                              provisions of 10 CFR parts 30, 32, 33,                  confidence in the regulatory system and                  Responses to this RFI will not be
                                              34, 35, 36, 39, 40, 50, 52, 54, 60, 61, 70,             to prevent unnecessary barriers to future             returned. The National Science and
                                              and 72.                                                 innovation and competitiveness by                     Technology Council is under no
                                                 7. The estimated number of annual                    improving the transparency,                           obligation to acknowledge receipt of the
                                              responses: 48.7.                                        coordination, predictability, and                     information received, or provide
                                                 8. The estimated number of annual                    efficiency of the regulation of                       feedback to respondents with respect to
                                              respondents: 48.7.                                      biotechnology products while                          any information submitted under this
                                                 9. An estimate of the total number of                continuing to protect health and the                  RFI. No requests for a bid package or
                                              hours needed annually to comply with                    environment.                                          solicitation will be accepted; no bid
                                              the information collection requirement                     The purpose of this Request for                    package or solicitation exists. This RFI
                                              or request: 48,104.                                     Information (RFI) is to solicit relevant              is issued solely for information and
                                                 10. Abstract: The NRC’s regulations at               data and information, including case                  planning purposes and does not
                                              10 CFR part 51 specifies information to                 studies, that can assist in the                       constitute a solicitation.
                                              be provided by applicants and licensees                 development of the proposed update to                 FOR FURTHER INFORMATION CONTACT:
                                              so that the NRC can make                                the Coordinated Framework for the                     National Science and Technology
tkelley on DSK3SPTVN1PROD with NOTICES




                                              determinations necessary to adhere to                   Regulation of Biotechnology (CF) to                   Council: Emerging Technologies
                                              the policies, regulations, and public                   clarify the current roles and                         Interagency Policy Coordination
                                              laws of the United States, which are                    responsibilities of the EPA, FDA, and                 Committee, Office of Science and
                                              interpreted and administered in                         USDA and the development of a long-                   Technology Policy, Executive Office of
                                              accordance with the provisions set forth                term strategy consistent with the                     the President, Eisenhower Executive
                                              in the National Environmental Policy                    objectives described in the July 2, 2015              Office Building, 1650 Pennsylvania
                                              Act of 1969, as amended.                                EOP memorandum. In addition to this                   Ave., Washington DC 20504, Phone:


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                                                                           Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices                                           60415

                                              202–456–4444, Online: https://                          responsibilities of the agencies that                 Relevant FDA Web sites
                                              www.whitehouse.gov/webform/contact-                     regulate the products of biotechnology                • http://www.fda.gov/Food/
                                              emerging-technologies-interagency-                      by accomplishing the following four                     FoodScienceResearch/Biotechnology/
                                              policy-coordinating-committee-national-                 objectives:                                           • http://www.fda.gov/Animal
                                              science-and                                                (i) Clarifying which biotechnology                   Veterinary/DevelopmentApproval
                                              SUPPLEMENTARY INFORMATION:                              product areas are within the authority                  Process/GeneticEngineering/
                                                                                                      and responsibility of each agency;                      GeneticallyEngineeredAnimals/
                                              Background Information
                                                                                                         (ii) clarifying the roles that each                  ucm113605.htm
                                                 In 1986, the Office of Science and                   agency plays for different product areas,
                                              Technology Policy (OSTP) issued the                     particularly for those product areas that             Relevant EPA Web sites
                                              Coordinated Framework for the                           fall within the responsibility of multiple            • http://www.epa.gov/pesticides/
                                              Regulation of Biotechnology (CF), which                 agencies, and how those roles relate to                 biopesticides/regtools/biotech-reg-
                                              outlined a comprehensive Federal                        each other in the course of a regulatory                prod.htm
                                              regulatory policy for ensuring the safety               assessment;                                           • http://www.epa.gov/biotech_rule/
                                              of biotechnology products. The CF                          (iii) clarifying a standard mechanism
                                              sought to achieve a balance between                                                                           Relevant USDA Web sites
                                                                                                      for communication and, as appropriate,
                                              regulation adequate to ensure the                       coordination among agencies, while                       • https://www.aphis.usda.gov/wps/
                                              protection of health and the                            they perform their respective regulatory              portal/aphis/ourfocus/biotechnology
                                              environment while maintaining                           functions, and for identifying agency                 A brief summary of these agencies’
                                              sufficient regulatory flexibility to avoid              designees responsible for this                        current roles follows.
                                              impeding innovation.                                    coordination function; and                               The FDA regulates products of
                                                 In 1992, OSTP issued an update to the
                                                                                                         (iv) clarifying the mechanism and                  genetically engineered (GE) organisms
                                              CF that sets forth a risk-based,
                                                                                                      timeline for regularly reviewing, and                 that fall within FDA’s authority under
                                              scientifically sound basis for the
                                                                                                      updating as appropriate, the CF to                    the Federal Food, Drug, and Cosmetic
                                              oversight of activities that introduce
                                                                                                      minimize delays, support innovation,                  (FD&C) Act and other statutes. The FDA
                                              biotechnology products into the
                                                                                                      protect health and the environment and                is responsible for ensuring the safety of
                                              environment (57 FR 6753; February 27,
                                              1992) (Ref. 3). The update affirmed that                promote the public trust in the                       all plant-derived human and animal
                                              Federal oversight should focus on the                   regulatory systems for biotechnology                  foods, including those that are from
                                              characteristics of the product, the                     products.                                             genetically engineered sources. FDA
                                              environment into which it is being                         As noted in the July 2, 2015 EOP                   also regulates GE animals under the new
                                              introduced, and the intended use of the                 memorandum, ‘‘biotechnology                           animal drug provisions of the FD&C Act,
                                              product, rather than the process by                     products’’ refers to products developed               and FDA’s regulations for new animal
                                              which the product is created.                           through genetic engineering or the                    drugs. (The actual regulated article is
                                                 On July 2, 2015 the Executive Office                 targeted or in vitro manipulation of                  the recombinant DNA construct inserted
                                              of the President (EOP) issued a                         genetic information of organisms,                     into a specific site in the genome of an
                                              memorandum directing the primary                        including plants, animals, and                        animal; as a shorthand, the FDA refers
                                              Federal agencies that have oversight                    microbes. It also covers some of the                  to the regulation of GE animals.)
                                              responsibilities for the products of                    products produced by such plants,                        Within USDA, the Animal and Plant
                                              biotechnology—the U.S. Environmental                    animals, and microbes or their derived                Health Inspection Service (APHIS) is
                                              Protection Agency (EPA), the Food and                   products as determined by existing                    responsible for protecting agriculture
                                              Drug Administration (FDA), and the                      statutes and regulations. Products such               from pests and diseases. Under the Plant
                                              U.S. Department of Agriculture                          as human drugs and medical devices are                Protection Act (PPA) and the Animal
                                              (USDA)—to update the CF to clarify the                  not the focus of the activities described             Health Protection Act (AHPA), USDA–
                                              current roles and responsibilities of the               in the memorandum.                                    APHIS has regulatory oversight over
                                              agencies that regulate the products of                     The purpose of this RFI is to solicit              products of modern biotechnology that
                                              biotechnology, develop a long-term                      relevant data and information, including              could pose a risk to plant and animal
                                              strategy to ensure that the Federal                     case studies, that can inform the                     health. The AHPA provides authority to
                                              biotechnology regulatory system is                      development of the proposed update to                 prohibit or restrict imports or entry into
                                              prepared for the future products of                     the CF and the development of a long-                 the United States or dissemination of
                                              biotechnology, and commission an                        term strategy consistent with the                     any pest or disease of livestock. GE
                                              independent, expert analysis of the                     objectives described in the July 2, 2015              animals and insects would be subject to
                                              future landscape of biotechnology                       EOP memorandum. In addition to this                   import or transport restrictions if there
                                              products. These efforts will build on the               RFI, the update to the CF will undergo                is a risk to animal health. The PPA, as
                                              regulatory principles described in the                  public comment before it is finalized.                amended, provides authority to regulate
                                              CF and the 1992 update to the CF. The                                                                         the introduction (i.e., importation,
                                                                                                      Information Requested                                 interstate movement, or release into the
                                              memorandum’s objectives are to ensure
                                              public confidence in the regulatory                       The National Science and Technology                 environment) of certain GE organisms
                                              system and to prevent unnecessary                       Council requests relevant data and                    and products. A GE organism is
                                              barriers to future innovation and                       information, including case studies, that             considered a regulated article if the
                                              competitiveness by improving the                        can inform the update to the CF by                    donor organism, recipient organism,
                                              transparency, coordination,                             clarifying the current roles and                      vector, or vector agent used in
tkelley on DSK3SPTVN1PROD with NOTICES




                                              predictability, and efficiency of the                   responsibilities of the EPA, FDA, and                 engineering the organism belongs to one
                                              regulation of biotechnology products                    USDA and the development of the long-                 of the taxa listed in the regulation and
                                              while continuing to protect health and                  term strategy consistent with the                     is also considered a plant pest. A GE
                                              the environment.                                        objectives described in the July 2, 2015              organism is also regulated when APHIS
                                                 The July 2, 2015 EOP memorandum                      EOP memorandum. For details on the                    has reason to believe that the GE
                                              stated that the update to the CF should                 current roles and responsibilities of                 organism may be a plant pest. A GE
                                              clarify the current roles and                           these agencies, refer to their Web sites.             organism is no longer subject to the


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                                              60416                        Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices

                                              plant pest provisions of the PPA or to                     5. Are there specific issues that                  more of the exemptions set forth in 5
                                              regulatory requirements when APHIS                      should be addressed in the update of the              U.S.C. 552b(c)(3), (5), (7), 9(B) and (10)
                                              determines that it is unlikely to pose a                CF or in the long-term strategy in order              and 17 CFR 200.402(a)(3), (5), (7), 9(ii)
                                              plant pest risk.                                        to increase the transparency,                         and (10), permit consideration of the
                                                The EPA under the Federal                             coordination, predictability, and                     scheduled matter at the Closed Meeting.
                                              Insecticide, Fungicide, and Rodenticide                 efficiency of the regulatory system for                 Commissioner Stein, as duty officer,
                                              Act (FIFRA) and the FD&C Act regulates                  the products of biotechnology?                        voted to consider the items listed for the
                                              the sale and distribution of all                        References                                            Closed Meeting in closed session.
                                              pesticides, including those produced                                                                            The subject matter of the Closed
                                              through genetic engineering. This                         These references are available                      Meeting will be:
                                              includes microorganisms, biochemicals                   electronically at http://
                                                                                                      www.regulations.gov. We have verified                   Institution and settlement of
                                              isolated from organisms, and plant-                                                                           injunctive actions;
                                              incorporated protectants (PIPs), a type                 the Web site addresses, but we are not
                                                                                                      responsible for any subsequent changes                  Institution and settlement of
                                              of pesticide intended to be produced                                                                          administrative proceedings;
                                              and used in living plants. Under the                    to Web sites after this document
                                                                                                      publishes in the Federal Register.                      Adjudicatory matters; and
                                              Toxic Substances Control Act (TSCA),
                                              EPA has oversight responsibilities for a                1. Executive Office of the President. Office of
                                                                                                                                                              Other matters relating to enforcement
                                              wide range of commercial, industrial,                        Science and Technology Policy, Office of         proceedings.
                                              and consumer applications of microbial                       Management and Budget, United States               At times, changes in Commission
                                              biotechnology. New chemicals                                 Trade Representative, and Council on             priorities require alterations in the
                                              produced through those microbial                             Environmental Quality. Modernizing the           scheduling of meeting items.
                                                                                                           Regulatory System for Biotechnology                For further information and to
                                              biotechnology applications are subject                       Products, July 2, 2015. Available online
                                              to premanufacturing review under                             at: https://www.whitehouse.gov/sites/
                                                                                                                                                            ascertain what, if any, matters have been
                                              TSCA.                                                        default/files/microsites/ostp/                   added, deleted or postponed, please
                                                                                                           modernizing_the_reg_system_for_                  contact the Office of the Secretary at
                                              Questions                                                    biotech_products_memo_final.pdf.                 (202) 551–5400.
                                                 Keeping in mind the principles of the                2. Executive Office of the President. Office of         Dated: October 1, 2015.
                                              regulation of the products of                                Science and Technology Policy.
                                                                                                           Coordinated Framework for Regulation             Brent J. Fields,
                                              biotechnology as articulated in the CF                                                                        Secretary.
                                                                                                           of Biotechnology. 51 FR 23302, June 26,
                                              and the 1992 update to the CF, as well                       1986. Available online at: http://               [FR Doc. 2015–25451 Filed 10–2–15; 11:15 am]
                                              as the objectives of the July 2, 2015 EOP                    www.aphis.usda.gov/brs/fedregister/              BILLING CODE 8011–01–P
                                              memorandum, respondents are welcome                          coordinated_framework.pdf
                                              to address one or more of the following                 3. Executive Office of the President. Office of
                                              questions in regards to the proposed                         Science and Technology Policy. Exercise
                                                                                                           of Federal Oversight Within Scope of
                                                                                                                                                            SECURITIES AND EXCHANGE
                                              update to the CF and the development
                                                                                                           Statutory Authority: Planned                     COMMISSION
                                              of the long-term strategy. Respondents
                                              are asked to indicate to which question                      Introductions of Biotechnology Products
                                                                                                           Into the Environment. 57 FR 6753,                [Release No. 34–76059; File No. SR–FINRA–
                                              responses are targeted.
                                                                                                           February 27, 1992. Available online at:          2015–033]
                                                 1. What additional clarification could                    https://www.whitehouse.gov/sites/
                                              be provided regarding which                                  default/files/microsites/ostp/57_fed_reg_        Self-Regulatory Organizations;
                                              biotechnology product areas are within                       6753__1992.pdf                                   Financial Industry Regulatory
                                              the statutory authority and                                                                                   Authority, Inc.; Notice of Filing of a
                                                                                                      Ted Wackler,
                                              responsibility of each agency?                                                                                Proposed Rule Change To Amend
                                                 2. What additional clarification could               Deputy Chief of Staff and Assistant Director.
                                                                                                                                                            FINRA Rule 0150 to Apply FINRA Rule
                                              be provided regarding the roles that                    [FR Doc. 2015–25325 Filed 10–5–15; 8:45 am]
                                                                                                                                                            2121 and its Supplementary Material
                                              each agency plays for different                         BILLING CODE 3270–F5–P
                                                                                                                                                            .01 and .02 to Transactions in
                                              biotechnology product areas,                                                                                  Exempted Securities That Are
                                              particularly for those product areas that                                                                     Government Securities
                                              fall within the responsibility of multiple              SECURITIES AND EXCHANGE
                                              agencies, and how those roles relate to                 COMMISSION                                            September 30, 2015.
                                              each other in the course of a regulatory                                                                         Pursuant to Section 19(b)(1) of the
                                              assessment?                                             Sunshine Act Meeting                                  Securities Exchange Act of 1934
                                                 3. How can Federal agencies improve                    Notice is hereby given, pursuant to                 (‘‘Act’’) 1 and Rule 19b–4 thereunder,2
                                              their communication to consumers,                       the provisions of the Government in the               notice is hereby given that on
                                              industry, and other stakeholders                        Sunshine Act, Public Law 94–409, that                 September 17, 2015, Financial Industry
                                              regarding the authorities, practices, and               the Securities and Exchange                           Regulatory Authority, Inc. (‘‘FINRA’’)
                                              bases for decision-making used to                       Commission will hold a Closed Meeting                 filed with the Securities and Exchange
                                              ensure the safety of the products of                    on Thursday, October 8, 2015 at 2:00                  Commission (‘‘SEC’’ or ‘‘Commission’’)
                                              biotechnology?                                          p.m.                                                  the proposed rule change as described
                                                 4. Are there relevant data and                         Commissioners, Counsel to the                       in Items I, II, and III below, which Items
                                              information, including case studies, that               Commissioners, the Secretary to the                   have been substantially prepared by
tkelley on DSK3SPTVN1PROD with NOTICES




                                              can inform the update to the CF or the                  Commission, and recording secretaries                 FINRA. The Commission is publishing
                                              development of the long-term strategy                   will attend the Closed Meeting. Certain               this notice to solicit comments on the
                                              regarding how to improve the                            staff members who have an interest in                 proposed rule change from interested
                                              transparency, coordination,                             the matters also may be present.                      persons.
                                              predictability, and efficiency of the                     The General Counsel of the
                                              regulatory system for the products of                   Commission, or her designee, has                        1 15   U.S.C. 78s(b)(1).
                                              biotechnology?                                          certified that, in her opinion, one or                  2 17   CFR 240.19b–4.



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Document Created: 2015-12-15 08:50:52
Document Modified: 2015-12-15 08:50:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of request for information.
DatesResponses must be received by November 13, 2015 at 5:00 p.m. EST to be considered.
ContactNational 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
FR Citation80 FR 60414 

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