80 FR 62538 - 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; Public Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 200 (October 16, 2015)

Under the auspices of the National Science and Technology Council, the Food and Drug Administration (FDA or the Agency), along with the Office of Science and Technology Policy (OSTP), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA), is announcing a public meeting, to be held on October 30, 2015, to discuss the memorandum entitled, ``Modernizing the Regulatory System for Biotechnology Products,'' issued by the Executive Office of the President (EOP) in July 2015. The purpose of the meeting is to inform the public about the activities described in the July 2015 memorandum; invite oral comments from interested parties; and provide information about how to submit written comments, data, or other information to the docket.

[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Notices]
[Pages 62538-62541]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26311]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3403]


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; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: Under the auspices of the National Science and Technology 
Council, the Food and Drug Administration (FDA or the Agency), along 
with the Office of Science and Technology Policy (OSTP), the 
Environmental Protection Agency (EPA), and the United States Department 
of Agriculture (USDA), is announcing a public meeting, to be held on 
October 30, 2015, to discuss the memorandum entitled, ``Modernizing the 
Regulatory System for Biotechnology Products,'' issued by the Executive 
Office of the President (EOP) in July 2015. The purpose of the meeting 
is to inform the public about the activities described in the July 2015 
memorandum; invite oral comments from interested parties; and provide 
information about how to submit written comments, data, or other 
information to the docket.

DATES: See section II, ``How to Participate in the Public Meeting'' in 
the SUPPLEMENTARY INFORMATION section of this document for the date and 
time of the public meeting, closing dates for advance registration, and 
information on deadlines for submitting either electronic or written 
comments to FDA's Division of Dockets Management. Comments may be 
submitted in writing until November 13, 2015.

ADDRESSES: See section II, ``How to Participate in the Public Meeting'' 
in the SUPPLEMENTARY INFORMATION section of this document.

[[Page 62539]]

    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the 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; Public Meeting.'' Comments received will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: For general questions about the 
meeting, to request an opportunity to make an oral presentation at the 
public meeting, to submit the full text or summary of an oral 
presentation, or for special accommodations due to a disability, 
contact the Office of Policy, Office of the Commissioner, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-4830, email: [email protected].
    For questions about the memorandum entitled, ``Modernizing the 
Regulatory System for Biotechnology Products,'' or related activities 
described in that memorandum, contact the 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, 202-456-4444, 
online: https://www.whitehouse.gov/webform/contact-emerging-technologies-interagency-policy-coordinating-committee-national-science-and.

SUPPLEMENTARY INFORMATION:

I. Background

    In 1986, OSTP issued the Coordinated Framework for 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 (51 FR 23302; June 
26, 1986) (Ref. 1).
    In 1992, OSTP issued an update to the CF that set 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. 2). 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 EOP issued a memorandum entitled, 
``Modernizing the Regulatory System for Biotechnology Products,'' (the 
EOP memorandum) directing the primary federal Agencies that have 
oversight responsibilities for the products of biotechnology--EPA, FDA, 
and USDA--to update the CF to clarify 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 (Ref. 3). These efforts will 
build on the regulatory principles described in the CF and the 1992 
update to the CF. The EOP 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.

[[Page 62540]]

    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:
    1. Clarifying which biotechnology product areas are within the 
authority and responsibility of each Agency.
    2. 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.
    3. 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.
    4. 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 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 EOP memorandum.
    In addition, on October 6, 2015, OSTP issued a notice of request 
for information (RFI) to solicit 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 (80 FR 60414). 
In addition to the RFI, the EOP noted that it will hold three public 
engagement sessions over the next 12 months (Ref. 4), and that the 
current update to the CF will undergo public notice and comment before 
it is finalized. This notice is announcing the first public engagement 
session.
    The purpose of this first public meeting is to inform the public 
about the activities described in the EOP memorandum; invite oral, 
stakeholder comments relevant to those activities; and provide 
information about how to submit written comments, data, or other 
information to the docket. At this public meeting, OSTP will provide an 
overview of the CF and the 1992 update to the CF, and discuss the 
activities described in the EOP memorandum. EPA, FDA, and USDA will 
provide an overview of their current approaches to regulating products 
of biotechnology. The agenda for this public meeting will be posted 
approximately 5 days before the meeting at: http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm463783.htm.

II. How To Participate in the Public Meeting

    OSTP, EPA, FDA, and USDA (collectively referred to as ``we'' or 
``us'') are holding the public meeting under the auspices of the 
National Science and Technology Council. The meeting will be held on 
October 30, 2015, in the White Oak Great Room, at FDA's White Oak 
Campus, Building 31 Conference Center, the Great Room (Rm. 1503 B&C), 
10903 New Hampshire Ave., Silver Spring, MD 20993-002. Entrance for the 
public meeting participants (non-FDA employees) is through Building 1 
where routine security check procedures will be performed. For parking 
and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Due to limited space and time, we encourage all persons 
who wish to attend the meeting to register early and in advance of the 
meeting. There is no fee to register for the public meeting, and 
registration will be on a first-come, first-served basis. Onsite 
registration will be accepted, as space permits, after all 
preregistered attendees are seated.
    Those requesting an opportunity to make an oral presentation during 
the time allotted for public comment at the meeting are asked to submit 
a request in advance and to provide information about any specific 
topic or issue to be addressed. There will not be an opportunity to 
display materials such as slide shows, videos, or other media during 
the meeting. If time permits, individuals or organizations that did not 
register in advance may be granted the opportunity to make an oral 
presentation. We would like to maximize the number of individuals who 
make a presentation at the meeting and will do our best to accommodate 
all persons who wish to make a presentation or express their opinions 
at the meeting.
    We encourage persons and groups who have similar interests to 
consolidate their information for presentation by a single 
representative. After reviewing the presentation requests, we will 
notify each participant before the meeting of the approximate start 
time of their presentation and of the amount of time allotted for the 
comment.
    While oral presentations from specific individuals and 
organizations will be necessarily limited due to time constraints 
during the public meeting, interested parties may submit electronic or 
written comments to the docket. All relevant data and documentation 
should be submitted with the comments to Docket No. FDA-2015-N-3403.
    Table 1 provides information on participation in the public 
meeting.

      Table 1--Information on Participation in the Public Meeting and on Submitting Comments to the Docket
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                                                               Electronic                             Other
                                           Date                  address           Address         information
----------------------------------------------------------------------------------------------------------------
Public meeting...............  October 30, 2015...........  http://           FDA's White Oak
                                                             www.fda.gov/      Campus,
                                                             Food/NewsEvents/  Building 31
                                                             WorkshopsMeetin   Conference
                                                             gsConferences/    Center, the
                                                             default.htm.      Great Room
                                                                               (1503-B&C),
                                                                               10903 New
                                                                               Hampshire Ave.,
                                                                               Silver Spring,
                                                                               MD 20993-002.
Deadline for registration....  October 21, 2015...........  http://           We encourage you  There is no
                                                             www.fda.gov/      to use            registration
                                                             Food/NewsEvents/  electronic        fee for the
                                                             WorkshopsMeetin   registration if   public
                                                             gsConferences/    possible \1\.     meetings. Early
                                                             default.htm.                        registration is
                                                            Docket No. FDA-                      recommended
                                                             2015-N-3403.                        because seating
                                                                                                 is limited.

[[Page 62541]]

 
Request to make a public       October 21, 2015...........  http://           ................  Requests made on
 comment.                                                    www.fda.gov/                        the day of the
                                                             Food/NewsEvents/                    meeting to make
                                                             WorkshopsMeetin                     an oral
                                                             gsConferences/                      presentation
                                                             default.htm.                        will be granted
                                                                                                 as time
                                                                                                 permits.
                                                                                                 Information on
                                                                                                 requests to
                                                                                                 make an oral
                                                                                                 presentation
                                                                                                 may be posted
                                                                                                 without change
                                                                                                 to http://www.regulations.gov, including
                                                                                                 any personal
                                                                                                 information
                                                                                                 provided.
Request special                October 21, 2015...........  Email:            Office of
 accommodations due to a                                     BiotechnologyUp   Policy, Office
 disability.                                                 [email protected]   of the
                                                             v.                Commissioner,
                                                                               U.S. Food and
                                                                               Drug
                                                                               Administration,
                                                                               10903 New
                                                                               Hampshire Ave.,
                                                                               Silver Spring,
                                                                               MD 20993, 301-
                                                                               796-4830.
Closing date for written       November 13, 2015..........  http://           See ADDRESSES
 comments.                                                   www.regulations   above.
                                                             .gov.
----------------------------------------------------------------------------------------------------------------
\1\ For questions about registering for the meeting, to register by phone, or to submit a notice of
  participation by mail, FAX or email, contact: Office of Policy, Office of the Commissioner, U.S. Food and Drug
  Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4830, email:
  [email protected].

III. Comments, Transcripts, and Recorded Video

    Information and data submitted voluntarily to us will become part 
of the administrative record for this activity, and will be accessible 
to the public at http://www.regulations.gov. The transcript of the 
proceedings from the public meeting will become part of the 
administrative record for this activity. Please be advised that as soon 
as a transcript is available, it will be accessible at http://www.regulations.gov and on FDA's Web site at: http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. It may also be 
viewed at the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to the Division of Freedom of Information, 5630 Fishers 
Lane, Rm. 1035, Rockville, MD 20857. Additionally, we will live webcast 
and record the public meeting. Once the recorded video is available, it 
will be accessible on FDA's Web site at: http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.

IV. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses as of the 
date this document publishes in the Federal Register, but Web sites are 
subject to change over time.

1. 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.
2. 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.
3. 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.
4. Executive Office of the President. Improving Transparency and 
Ensuring Continued Safety in Biotechnology, blog post, July 2, 2015. 
Available online at: https://www.whitehouse.gov/blog/2015/07/02/improving-transparency-and-ensuring-continued-safety-biotechnology.

    Dated: October 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26311 Filed 10-15-15; 8:45 am]
 BILLING CODE 4164-01-P