Document ID: FDA-2014-N-2235-1005
Agency: fda
Document Type: Notice
Title: Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes; Extension of Comment Period
Posted Date: 2016-04-14T04:00Z

[Federal Register Volume 81, Number 72 (Thursday, April 14, 2016)]
[Notices]
[Pages 22092-22093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08678]

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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; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the notice that appeared in the Federal Register of 
March 14, 2016. In the notice, FDA requested comments on the Draft 
Environmental Assessment and Preliminary Finding of No Significant 
Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes. The 
Agency is taking this action in response to requests for an extension 
to allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the notice published 
March 14, 2016 (81 FR 13371). Submit either electronic or written 
comments by May 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

[[Page 22093]]

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 draft 
Environmental Assessment (EA) and preliminary Finding of No Significant 
Impact (FONSI) 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 and preliminary FONSI 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: abig@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 16, 2016, 
FDA published a notice with a 30-day comment period to request comments 
on the Draft Environmental Assessment and Preliminary Finding of No 
Significant Impact Concerning Investigational Use of Oxitec OX513A 
Mosquitoes.
    The Agency has received requests for a 90-day extension of the 
comment period for the notice. Each request conveyed concern that the 
current 30-day comment period does not allow sufficient time to develop 
a meaningful or thoughtful response to the notice.
    FDA has considered the requests and is extending the comment period 
for the notice for 30 days, until May 13, 2016. The Agency believes 
that a 30-day extension allows adequate time for interested persons to 
submit comments without significantly delaying the Agency's decision on 
whether to finalize these documents or prepare an Environmental Impact 
Statement.

    Dated: April 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08678 Filed 4-13-16; 8:45 am]
 BILLING CODE 4164-01-P