[Federal Register Volume 78, Number 31 (Thursday, February 14, 2013)]
[Notices]
[Pages 10620-10621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03445]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0899]


Draft Environmental Assessment and Preliminary Finding of No 
Significant Impact Concerning a Genetically Engineered Atlantic Salmon; 
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 two draft environmental review documents for which a 
notice of availability appeared in the Federal Register of December 26, 
2012. In that notice, FDA made available for comment the Agency's draft 
environmental assessment (EA) of the proposed conditions of use 
specified in materials submitted by AquaBounty Technologies, Inc., in 
support of a new animal drug application (NADA) concerning a 
genetically engineered (GE) Atlantic salmon and a preliminary finding 
of no significant impact (FONSI) for those specific conditions of use. 
The Agency is taking this action in response to a request for an 
extension to allow interested persons additional time to submit 
comments.

DATES: Submit either electronic or written comments by April 26, 2013.

ADDRESSES: Submit electronic comments to: http://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. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Eric Silberhorn, Center for Veterinary 
Medicine (HFV-162), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855; 240-276-8247; abig@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 26, 2012 (77 FR 76050), FDA 
published a notice of availability with a 60-day comment period to make 
available for public comment the Agency's draft EA of the proposed 
conditions of use specified in materials submitted by AquaBounty 
Technologies, Inc., in support of an NADA concerning a GE

[[Page 10621]]

Atlantic salmon and a preliminary FONSI for those specific conditions 
of use. Comments on the draft EA and FONSI will inform FDA's decision 
whether to require an environmental impact statement (EIS) or finalize 
the EA and FONSI for this NADA.
    The Agency has received a request for a 60-day extension of the 
comment period for the draft EA and FONSI. The request conveyed concern 
that the current 60-day comment period does not allow sufficient time 
to respond.
    FDA has considered the request and is extending the comment period 
for the draft EA and FONSI for 60 days, until April 26, 2013. The 
Agency believes that a 60-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 EIS.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
these documents to http://www.regulations.gov or written comments to 
the Division of Dockets Management (see ADDRESSES). 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, and will be posted to 
the docket at http://www.regulations.gov.

    Dated: February 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03445 Filed 2-13-13; 8:45 am]
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