Document ID: FDA-2016-N-4389-0274
Agency: fda
Document Type: Notice
Title: Genome Editing in New Plant Varieties Used for Foods; Extension of
Comment Period
Posted Date: 2017-04-13T04:00Z

[Federal Register Volume 82, Number 70 (Thursday, April 13, 2017)]
[Notices]
[Pages 17840-17841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07469]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4389]

Genome Editing in New Plant Varieties Used for Foods; Extension 
of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for a docket to receive information and comments on the 
use of genome editing techniques to produce new plant varieties that 
are used for human or animal food. We established the docket through a 
notice that appeared in the Federal Register of January 19, 2017. We 
are taking this action in response to requests for an extension to 
allow interested persons additional time to submit comments.

DATES: We are extending the comment period on the notice that published 
January 19, 2017 (82 FR 6564). Submit either electronic or written 
comments by June 19, 2017. Late, untimely filed comments will not be 
considered. The https://www.regulations.gov electronic filing system 
will accept comments until midnight Eastern Time at the end of June 19, 
2017. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or 
the delivery service acceptance receipt is on or before that date.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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.

[[Page 17841]]

     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 2016-N-4389 for ``Genome Editing in New Plant Varieties Used for 
Foods.'' Received comments, those filed in a timely manner (see DATES), 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://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.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://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: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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.

FOR FURTHER INFORMATION CONTACT: 
    Regarding human food issues: Jason Dietz, Center for Food Safety 
and Applied Nutrition (HFS-205), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2282.
    Regarding animal food issues: Kathleen Jones, Center for Veterinary 
Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5938.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 19, 2017, 
we published a notice announcing the establishment of a docket to 
receive comments on the use of genome editing techniques to produce new 
plant varieties that are used for human or animal food. We requested 
these comments because we recognize that developers of new plant 
varieties, researchers, and other stakeholders may have valuable 
factual information and data about foods derived from new plant 
varieties produced using genome editing, which can help inform FDA's 
thinking for these specific products. The notice also discussed the 
history of FDA's thinking regarding these products, our long history of 
consultations with developers, researchers, and other stakeholders, and 
specific questions and issues for which we invited comments. We 
provided a 90-day comment period that was scheduled to end on April 19, 
2017.
    We have received requests for a 60-day extension of the comment 
period. The requests conveyed concern that the current 90-day comment 
period does not allow sufficient time to develop a meaningful or 
thoughtful comments to the questions and issues we presented in the 
notice.
    We have considered the requests and are extending the comment 
period for 60 days, until June 19, 2017. A 60-day extension allows more 
time for interested persons to submit comments to the docket on this 
issue.

    Dated: April 7, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-07469 Filed 4-12-17; 8:45 am]
 BILLING CODE 4164-01-P