Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes; Availability, 13371-13372 [2016-05622]
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Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices
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SUBMISSION@OMB.EOP.GOV, Attn:
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[FR Doc. 2016–05605 Filed 3–11–16; 8:45 am]
BILLING CODE 4184–73–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2235]
Draft Environmental Assessment and
Preliminary Finding of No Significant
Impact Concerning Investigational Use
of Oxitec OX513A Mosquitoes;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency) is
announcing the availability for public
comment of the draft environmental
assessment (EA) submitted by Oxitec
Ltd. and a preliminary finding of no
significant impact (FONSI) in support of
the conduct of an investigational release
of genetically engineered (GE)
mosquitoes under an investigational
new animal drug exemption.
DATES: Submit either electronic or
written comments on the draft EA by
April 13, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
jstallworth on DSK7TPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
14:27 Mar 11, 2016
Jkt 238001
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–
2014–N–2235 for Draft Environmental
Assessment and Preliminary Finding of
No Significant Impact Concerning
Investigational Use of Oxitec OX513A
Mosquitoes. Received comments 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
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13371
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.
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Persons with access to the Internet may
obtain the draft EA at either https://
www.fda.gov/animalveterinary/
developmentapprovalprocess/
environmentalassessments/
ucm300656.htm or https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Brinda Dass, Center for Veterinary
Medicine (HFV–2), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8247,
email: abig@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing that a draft EA and
preliminary FONSI, in support of a
proposed investigational release (i.e.,
field trial) of OX513A Aedes aegypti GE
mosquitoes (OX513A mosquitoes), as
part of an existing mosquito control
program in Key Haven, FL, are being
made available for public comment. The
OX513A is a strain of Ae. aegypti
mosquito whose recombinant DNA
(rDNA) construct encodes a conditional
lethality trait such that the offspring of
the matings of male OX513A
mosquitoes and wild type Ae. aegypti
do not survive to adulthood. The
intended result is a decrease in the
overall population of Ae. aegypti in the
environment. Only male OX513A
mosquitoes are intended to be released.
To encourage public transparency,
and in compliance with 21 CFR
25.51(b)(3), the Agency is placing Oxitec
Ltd.’s draft EA and preliminary FONSI
that are the subject of this notice on
public display at the Division of Dockets
E:\FR\FM\14MRN1.SGM
14MRN1
13372
Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices
Management (see DATES and ADDRESSES)
for public review and comment for 30
days. Oxitec Ltd. prepared the draft EA.
The preliminary FONSI is based upon
Oxitec Ltd.’s draft EA. FDA is
considering the draft EA and tentatively
agrees with its conclusion that conduct
of this trial will result in no significant
impacts on the environment. If nothing
changes FDA’s tentative determination,
FDA will prepare and release its own
revised, final EA and final FONSI. The
Agency intends to take comments
received under advisement in
determining whether to prepare a
revised, final EA and FONSI. If FDA
does not agree with the preliminary
conclusion that conduct of this trial will
result in no significant impacts on the
environment, it will prepare an
environmental impact statement.
Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05622 Filed 3–11–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0820]
Drug Safety and Risk Management
Advisory Committee and the
Anesthetic and Analgesic Drug
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
jstallworth on DSK7TPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: Drug Safety and
Risk Management Advisory Committee
and the Anesthetic and Analgesic Drug
Products Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 3, 2016, from 8 a.m. to 5
p.m. and May 4, 2016, from 8 a.m. to 5
p.m.
ADDRESSES: FDA is opening a docket for
public comment on this meeting. The
docket number is FDA–2016–N–0820.
The docket will open for public
comment on March 14, 2016. The
docket will close on June 4, 2016.
Interested persons may submit either
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14:27 Mar 11, 2016
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electronic or written comments
regarding this meeting. Submit
electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments received will be posted
without change, including any personal
information provided. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Comments received on or before April
19, 2016, will be provided to the
committees before the meeting.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Stephanie L.
Begansky, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, Fax:
301–847–8533, email: AADPAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85) requires FDA to
bring, at least annually, one or more
drugs with Risk Evaluation and
Mitigation Strategies (REMS) with
Elements to Assure Safe Use (ETASU)
before its Drug Safety and Risk
Management Advisory Committee
(DSaRM). On May 3 and 4, 2016, the
committees will discuss results from
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assessments of the extended-release and
long-acting (ER/LA) Opioid Analgesics
REMS. The Agency will seek the
committees’ comments as to whether
this REMS with ETASU assures safe
use, is not unduly burdensome to
patient access to the drugs, and to the
extent practicable, minimizes the
burden to the healthcare delivery
system.
The ER/LA Opioid Analgesics REMS
requires that prescriber training will be
made available to healthcare providers
who prescribe ER/LA opioid analgesics.
Training is considered ‘‘REMScompliant’’ if: (1) It, for training
provided by continuing education
providers, is offered by an accredited
provider to licensed prescribers, (2) it
includes all elements of the FDA
Blueprint for Prescriber Education for
ER/LA Opioid Analgesics (Blueprint),
(3) it includes a knowledge assessment
of all the sections of the Blueprint, and
(4) it is subject to independent audit to
confirm that conditions of the REMS
training have been met. The Agency will
seek the committees’ input on possible
modifications to the ER/LA Opioid
Analgesics REMS, including expansion
of the scope and content of prescriber
training and expansion of the REMS
program to include immediate-release
opioids.
Comments from the public can be
submitted to the docket (see the
ADDRESSES section) on a broad
evaluation of the ER/LA Opioid
Analgesics REMS program and whether
the ER/LA opioid analgesics REMS
should be modified as well as any
proposed modifications. Comments may
include but are not limited to: (1)
Alternative methodologies for
evaluating the overall impact of the
program on knowledge and behavior by
prescribers and patients, (2) the overall
impact of the REMS on the adverse
events it is intended to mitigate; (3)
whether the FDA Blueprint or other
tools (e.g., Medication Guide or Patient
Counseling Document) should be
revised and/or expanded; (4) the use of
the continuing education as a
component of the REMS as a
mechanism for providing prescriber
training; (5) whether to expand the
REMS program to include immediaterelease opioids; and (6) how additional
REMS tools or ETASU (e.g., required
prescriber or pharmacist training,
required patient agreements), if
recommended, may impact the
healthcare delivery system and patient
access to ER/LA opioid analgesics.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
E:\FR\FM\14MRN1.SGM
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Agencies
[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13371-13372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05622]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-2235]
Draft Environmental Assessment and Preliminary Finding of No
Significant Impact Concerning Investigational Use of Oxitec OX513A
Mosquitoes; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency) is
announcing the availability for public comment of the draft
environmental assessment (EA) submitted by Oxitec Ltd. and a
preliminary finding of no significant impact (FONSI) in support of the
conduct of an investigational release of genetically engineered (GE)
mosquitoes under an investigational new animal drug exemption.
DATES: Submit either electronic or written comments on the draft EA by
April 13, 2016.
ADDRESSES: 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-2014-N-2235 for Draft Environmental Assessment and Preliminary
Finding of No Significant Impact Concerning Investigational Use of
Oxitec OX513A Mosquitoes. Received comments 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.
Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. Persons with access to the Internet may
obtain the draft EA at either https://www.fda.gov/animalveterinary/developmentapprovalprocess/environmentalassessments/ucm300656.htm or
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Brinda Dass, Center for Veterinary
Medicine (HFV-2), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8247, email: abig@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is announcing that a draft EA and
preliminary FONSI, in support of a proposed investigational release
(i.e., field trial) of OX513A Aedes aegypti GE mosquitoes (OX513A
mosquitoes), as part of an existing mosquito control program in Key
Haven, FL, are being made available for public comment. The OX513A is a
strain of Ae. aegypti mosquito whose recombinant DNA (rDNA) construct
encodes a conditional lethality trait such that the offspring of the
matings of male OX513A mosquitoes and wild type Ae. aegypti do not
survive to adulthood. The intended result is a decrease in the overall
population of Ae. aegypti in the environment. Only male OX513A
mosquitoes are intended to be released.
To encourage public transparency, and in compliance with 21 CFR
25.51(b)(3), the Agency is placing Oxitec Ltd.'s draft EA and
preliminary FONSI that are the subject of this notice on public display
at the Division of Dockets
[[Page 13372]]
Management (see DATES and ADDRESSES) for public review and comment for
30 days. Oxitec Ltd. prepared the draft EA. The preliminary FONSI is
based upon Oxitec Ltd.'s draft EA. FDA is considering the draft EA and
tentatively agrees with its conclusion that conduct of this trial will
result in no significant impacts on the environment. If nothing changes
FDA's tentative determination, FDA will prepare and release its own
revised, final EA and final FONSI. The Agency intends to take comments
received under advisement in determining whether to prepare a revised,
final EA and FONSI. If FDA does not agree with the preliminary
conclusion that conduct of this trial will result in no significant
impacts on the environment, it will prepare an environmental impact
statement.
Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05622 Filed 3-11-16; 8:45 am]
BILLING CODE 4164-01-P