[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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