Document ID: FDA-2008-D-0394-0325
Agency: fda
Document Type: Notice
Title: Regulation of Intentionally Altered Genomic DNA in Animals; Extension of
Comment Period
Posted Date: 2017-04-13T04:00Z

[Federal Register Volume 82, Number 70 (Thursday, April 13, 2017)]
[Notices]
[Pages 17844-17845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07470]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0394]

Regulation of Intentionally Altered Genomic DNA in Animals; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the draft guidance for industry (GFI) #187 entitled 
``Regulation of Intentionally Altered Genomic DNA in Animals'' that was 
announced 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DATES: We are extending the comment period on the draft guidance 
published January 19, 2017 (82 FR 6561). Although you can comment on 
any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we 
consider your comment on this draft guidance, submit either electronic 
or written comments on the draft guidance by June 19, 2017.

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.
     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-2008-D-0394 for ``Regulation of Intentionally Altered Genomic DNA 
in Animals.'' Received comments 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.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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: Laura R. Epstein, Center for 
Veterinary Medicine (HFV-1), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-796-8558, 
laura.epstein@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 19, 2017, 
FDA published a notice announcing the availability of draft GFI #187 
entitled ``Regulation of Intentionally Altered Genomic DNA in Animals'' 
with a 90-day comment period. We requested comments on expanding the 
scope of the guidance to address animals intentionally altered through 
use of genome editing techniques, nomenclature, and on whether certain

[[Page 17845]]

types of genome editing may pose minimal risk.
    We have received several requests for a 60-day extension of the 
comment period for the draft guidance and the questions we posted in 
the notice announcing the availability of the guidance. Each request 
conveyed concern that the current 90-day comment period does not allow 
sufficient time to develop a meaningful or thoughtful response to the 
draft guidance and the questions in the notice.
    We have considered the requests and are extending the comment 
period for the draft guidance for 60 days, until June 19, 2017. A 60-
day extension allows more time for interested persons to submit 
comments, including comments on all aspects of the draft guidance.

    Dated: April 7, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-07470 Filed 4-12-17; 8:45 am]
 BILLING CODE 4164-01-P