[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]
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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.
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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: 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-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 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.
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 http://www.fda.gov/animalveterinary/developmentapprovalprocess/environmentalassessments/ucm300656.htm or
http://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: [email protected].
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]
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