2017-07470. 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.

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The Food and Drug Administration (FDA or we) is extending the comment period for the draft guidance for industry (GFI) #187 entitled “Regulation of Intentionally Altered Genomic DNA in Animals” that was announced in the Federal Register of January 19, 2017.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We are extending the comment period on the draft guidance published January 19, 2017 (82 FR 6561).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you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance, submit either electronic or written comments on the draft guidance by June 19, 2017.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

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 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.