[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Notices]
[Page 76050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-31118]


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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; 
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 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. Also available for comment 
is the Agency's preliminary finding of no significant impact (FONSI) 
for those specific conditions of use.

DATES: Submit either electronic or written comments on the Agency's 
draft EA and preliminary FONSI by February 25, 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, email:[email protected].

SUPPLEMENTARY INFORMATION: Notice is given that a draft EA prepared by 
FDA in support of an NADA associated with AQUADVANTAGE Salmon, a GE 
Atlantic salmon containing the opAFP-GHc2 recombinant DNA construct is 
being made available for public comment. FDA is also making available 
for comment the Agency's preliminary FONSI for those specific 
conditions of use. In the event of an approval of the application, the 
approval would only allow AQUADVANTAGE Salmon to be produced and grown-
out in the physically contained freshwater culture facilities specified 
in the sponsor's NADA.
    To encourage public participation consistent with regulations 
implementing the National Environmental Policy Act (40 CFR 1501.4(b)), 
the Agency is placing the draft EA and the preliminary FONSI that are 
the subject of this notice on public display at the Division of Dockets 
Management (see DATES and ADDRESSES) for public review and comment for 
60 days. Given that the substance of this draft EA was made available 
to the public in advance of the Agency's 2010 Veterinary Medicine 
Advisory Committee meeting and consistent with the Agency's regulations 
implementing the National Environmental Policy Act (21 CFR 
25.51(b)(3)), FDA believes that a 60-day comment period is appropriate 
and does not intend to grant requests for extension of the comment 
period.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. 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. FDA will 
also place on public display any amendments to, or comments on, the 
Agency's draft EA and preliminary FONSI without further announcement in 
the Federal Register.
    If, based on its review, the Agency finds that an environmental 
impact statement is not required and the NADA results in an approval by 
the Agency, the notice of availability of the Agency's EA and FONSI, as 
well as any supporting evidence, will be published with the regulation 
describing the approval in the Federal Register in accordance with 21 
CFR 25.51(b).

    Dated: December 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-31118 Filed 12-21-12; 11:15 am]
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