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, 62538-62541 [2015-26311]
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Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices
srobinson on DSK5SPTVN1PROD with NOTICES
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7212,
Silver Spring, MD 20993–0002, 301–
796–8377.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: Europe, Japan, and North
America. The eight ICH sponsors are the
European Commission; the European
Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of
Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers
Association; CDER and CBER, FDA; the
Pharmaceutical Research and
Manufacturers of America; Health
Canada; and Swissmedic. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization.
In the Federal Register of December
24, 1997 (62 FR 67377), FDA published
the ICH guidance for industry entitled
‘‘Q3C Impurities: Residual Solvents.’’
The guidance makes recommendations
as to what amounts of residual solvents
are considered to be toxicologically
acceptable for some residual solvents.
Upon issuance in 1997, the text and
appendix 1 of the guidance contained
several tables and a list of solvents
categorizing residual solvents by
toxicity, classes 1 through 3, with class
1 being the most toxic. The ICH Quality
Expert Working Group (EWG) agreed
that the PDE could be modified if
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reliable and more relevant toxicity data
were brought to the attention of the
group and the modified PDE could
result in a revision of the tables and list.
In 1999, ICH instituted a Q3C
maintenance agreement and formed a
maintenance EWG (Q3C EWG). The
agreement provided for the revisitation
of solvent PDEs and allowed for minor
changes to the tables and list that
include the existing PDEs. The
agreement also provided that new
solvents and PDEs could be added to the
tables and list based on adequate
toxicity data. In the Federal Register of
February 12, 2002 (67 FR 6542), FDA
briefly described the process for
proposing future revisions to the PDE.
In the same notice, the Agency
announced its decision to delink the
tables and list from the Q3C guidance
and create a stand-alone document
entitled ‘‘Q3C: Tables and List’’ to
facilitate making changes recommended
by ICH.
In June 2015, the ICH Steering
Committee agreed that draft
recommendations for a new PDE for the
residual solvent triethylamine and a
revised PDE for the residual solvent
methylisobutylketone should be made
available for public comment. The draft
recommendations are the product of the
Quality Expert Working Group of the
ICH. Comments about this draft will be
considered by FDA and the Quality
Expert Working Group.
The draft recommendations provide
guidance on the new PDE for the solvent
trimethylamine and the revised PDE for
the solvent methylisobutylketone. In
addition, the data used to derive the
PDEs are summarized. The document is
intended to recommend acceptable
amounts for the listed residual solvents
in pharmaceuticals for the safety of the
patient.
The draft recommendations are being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft recommendations for
the solvents trimethylamine and
methylisobutylketone, when finalized,
will represent the current thinking of
FDA on this topic. They do not establish
any rights for any person and are not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://www.fda.gov/
PO 00000
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BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm.
Dated: October 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26361 Filed 10–15–15; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
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Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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’’).
srobinson on DSK5SPTVN1PROD with NOTICES
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
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
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• 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
https://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: https://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 https://
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:
BiotechnologyUpdate@fda.hhs.gov.
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
PO 00000
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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-technologiesinteragency-policy-coordinatingcommittee-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.
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Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices
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: https://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 https://
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
Date
Electronic address
Address
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Public meeting ..........
October 30, 2015 ......
https://www.fda.gov/Food/
NewsEvents/Workshops
MeetingsConferences/default.htm.
Deadline for registration.
October 21, 2015 ......
https://www.fda.gov/Food/News
Events/WorkshopsMeetings
Conferences/default.htm.
Docket No. FDA–2015–N–
3403.
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Other information
FDA’s White Oak Campus,
Building 31 Conference
Center, the Great Room
(1503–B&C), 10903 New
Hampshire Ave., Silver
Spring, MD 20993–002.
We encourage you to use
electronic registration if possible 1.
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There is no registration fee for
the public meetings. Early
registration is recommended
because seating is limited.
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Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices
TABLE 1—INFORMATION ON PARTICIPATION IN THE PUBLIC MEETING AND ON SUBMITTING COMMENTS TO THE DOCKET—
Continued
Date
Electronic address
Address
Other information
Request to make a
public comment.
October 21, 2015 ......
https://www.fda.gov/Food/News
Events/WorkshopsMeetings
Conferences/default.htm.
.................................................
Requests made on the day of
the meeting to make an oral
presentation will be granted
as time permits. Information
on requests to make an oral
presentation may be posted
without change to https://
www.regulations.gov, including any personal information provided.
Request special accommodations due
to a disability.
October 21, 2015 ......
Email: BiotechnologyUpdate@
fda.hhs.gov.
Closing date for written comments.
November 13, 2015 ..
https://www.regulations.gov ......
Office of Policy, Office of the
Commissioner, U.S. Food
and Drug Administration,
10903 New Hampshire
Ave., Silver Spring, MD
20993, 301–796–4830.
See ADDRESSES above.
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: BiotechnologyUpdate@fda.hhs.gov.
III. Comments, Transcripts, and
Recorded Video
srobinson on DSK5SPTVN1PROD with NOTICES
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
https://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 https://www.regulations.gov
and on FDA’s Web site at: https://
www.fda.gov/Food/NewsEvents/Work
shopsMeetingsConferences/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: https://
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
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also available electronically at https://
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.
Dated: October 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
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: https://
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-andensuring-continued-safetybiotechnology.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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[FR Doc. 2015–26311 Filed 10–15–15; 8:45 am]
BILLING CODE 4164–01–P
National Institutes of Health
Proposed Collection; 60-day Comment
Request; Media-Smart Youth Leaders
Program (NICHD)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), National
Institutes of Health (NIH), will issue a
funding announcement for the MediaSmart Youth Leaders Program to the
Office of Management and Budget
(OMB) for review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: Whether the proposed
collection of information is necessary
for the proper selection of facilitators to
serve as local health educators, using
the Media-Smart Youth curriculum; the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information; ways to enhance the
quality, utility, and clarity of the
information to be collected; and ways to
minimize the burden of the collection of
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Notices]
[Pages 62538-62541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26311]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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: BiotechnologyUpdate@fda.hhs.gov.
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: https://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 https://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
----------------------------------------------------------------------------------------------------------------
Electronic Other
Date address Address information
----------------------------------------------------------------------------------------------------------------
Public meeting............... October 30, 2015........... https:// 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........... https:// 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........... https:// ................ 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 https://www.regulations.gov, including
any personal
information
provided.
Request special October 21, 2015........... Email: Office of
accommodations due to a BiotechnologyUp Policy, Office
disability. date@fda.hhs.go 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.......... https:// 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:
BiotechnologyUpdate@fda.hhs.gov.
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 https://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 https://www.regulations.gov and on FDA's Web site at: https://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: https://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 https://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:
https://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
