[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Notices]
[Page 76050]
From the Federal Register Online via the Government Printing 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:abig@fda.hhs.gov.
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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