82 FR 17844 - Regulation of Intentionally Altered Genomic DNA in Animals; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 70 (April 13, 2017)

Page Range		17844-17845
FR Document		2017-07470

The Food and Drug Administration (FDA or we) is extending the comment period for the draft guidance for industry (GFI) #187 entitled ``Regulation of Intentionally Altered Genomic DNA in Animals'' that was announced in the Federal Register of January 19, 2017.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.

Federal Register, Volume 82 Issue 70 (Thursday, April 13, 2017)

[Federal Register Volume 82, Number 70 (Thursday, April 13, 2017)]
[Notices]
[Pages 17844-17845]
From the Federal Register Online  [www.thefederalregister.org]
[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comment period for the draft guidance for industry (GFI) #187 entitled 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DATES: We are extending the comment period on the draft guidance 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consider your comment on this draft guidance, submit either electronic 
or written comments on the draft guidance by June 19, 2017.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.thefederalregister.org/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, 
[email protected].

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

Federal Register / Vol. 82, No. 70 / Thursday, April 13, 2017 / Notices 17845

types of genome editing may pose Name of Committee: National Diabetes and Date: May 10, 2017.
minimal risk. Digestive and Kidney Diseases Advisory Closed: 1:00 p.m. to 2:00 p.m.
Council. Agenda: To review and evaluate grant
We have received several requests for Date: May 10, 2017. applications.
a 60-day extension of the comment Open: 8:30 a.m. to 12:00 p.m. Place: National Institutes of Health,
period for the draft guidance and the Agenda: To present the Director’s Report Building 31, C Wing, Conference Center,
questions we posted in the notice and other scientific presentations. Room 10, 31 Center Drive, Bethesda, MD
announcing the availability of the Place: National Institutes of Health, 20892.
guidance. Each request conveyed Building 31, C Wing, Conference Room 10, Open: 2:00 p.m. to 4:00 p.m.
31 Center Drive, Bethesda, MD 20892. Agenda: To review the Division’s scientific
concern that the current 90-day Closed: 4:15 p.m. to 4:30 p.m. and planning activities.
comment period does not allow Agenda: To review and evaluate grant Place: National Institutes of Health,
sufficient time to develop a meaningful applications. Building 31, C Wing, Conference Center,
or thoughtful response to the draft Place: National Institutes of Health, Room 10, 31 Center Drive, Bethesda, MD
guidance and the questions in the Building 31, C Wing, Conference Room 10, 20892.
notice. 31 Center Drive, Bethesda, MD 20892. Contact Person: Brent B. Stanfield, Ph.D.,
Contact Person: Brent B. Stanfield, Ph.D., Director, Division of Extramural Activities,
We have considered the requests and Director, Division of Extramural Activities, National Institutes of Diabetes and Digestive
are extending the comment period for National Institutes of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd.,
the draft guidance for 60 days, until and Kidney Diseases, 6707 Democracy Blvd., Room 7323, MSC 5452, Bethesda, MD 20892,
June 19, 2017. A 60-day extension Room 7323, MSC 5452 Bethesda, MD 20892, (301) 594–8843, stanfibr@niddk.nih.gov.
allows more time for interested persons (301) 594–8843, stanfibr@niddk.nih.gov.
Any interested person may file written
to submit comments, including Name of Committee: National Diabetes and comments with the committee by forwarding
comments on all aspects of the draft Digestive and Kidney Diseases Advisory the statement to the Contact Person listed on
guidance. Council, Digestive Diseases and Nutrition this notice. The statement should include the
Subcommittee. name, address, telephone number and when
Dated: April 7, 2017. Date: May 10, 2017. applicable, the business or professional
Anna K. Abram, Open: 1:00 p.m. to 2:30 p.m. affiliation of the interested person.
Deputy Commissioner for Policy, Planning, Agenda: To review the Division’s scientific In the interest of security, NIH has
Legislation, and Analysis. and planning activities. instituted stringent procedures for entrance
[FR Doc. 2017–07470 Filed 4–12–17; 8:45 am]
Place: National Institutes of Health, onto the NIH campus. All visitor vehicles,
Building 31, C Wing, Conference Center, including taxicabs, hotel, and airport shuttles
BILLING CODE 4164–01–P Room 6, 31 Center Drive, Bethesda, MD will be inspected before being allowed on
20892. campus. Visitors will be asked to show one
Closed: 2:30 p.m. to 4:00 p.m. form of identification (for example, a
DEPARTMENT OF HEALTH AND Agenda: To review and evaluate grant government-issued photo ID, driver’s license,
HUMAN SERVICES applications. or passport) and to state the purpose of their
Place: National Institutes of Health,
visit.
National Institutes of Health Building 31, C Wing, Conference Center,
Information is also available on the
Room 6, 31 Center Drive, Bethesda, MD
Institute’s/Center’s home page:
National Institute of Diabetes and 20892.
www.niddk.nih.gov/fund/divisions/DEA/
Digestive and Kidney Diseases; Notice Contact Person: Brent B. Stanfield, Ph.D.,
Council/coundesc.htm., where an agenda and
of Meetings Director, Division of Extramural Activities,
any additional information for the meeting
National Institutes of Diabetes and Digestive
will be posted when available.
Pursuant to section 10(d) of the and Kidney Diseases, 6707 Democracy Blvd.,
Room 7323, MSC 5452, Bethesda, MD 20892, (Catalogue of Federal Domestic Assistance
Federal Advisory Committee Act, as (301) 594–8843, stanfibr@niddk.nih.gov. Program Nos. 93.847, Diabetes,
amended (5 U.S.C. App.), notice is Endocrinology and Metabolic Research;
Name of Committee: National Diabetes and
hereby given of meetings of the National Digestive and Kidney Diseases Advisory 93.848, Digestive Diseases and Nutrition
Diabetes and Digestive and Kidney Council, Kidney, Urologic and Hematologic Research; 93.849, Kidney Diseases, Urology
Diseases Advisory Council. Diseases Subcommittee. and Hematology Research, National Institutes
Date: May 10, 2017. of Health, HHS)
The meetings will be open to the
public as indicated below, with Open: 1:00 p.m. to 2:15 p.m. Dated: April 10, 2017.
Agenda: To review the Division’s scientific David Clary,
attendance limited to space available. and planning activities.
Individuals who plan to attend and Program Analyst, Office of Federal Advisory
Place: National Institutes of Health,
need special assistance, such as sign Building 31, C Wing, Conference Center, Committee Policy.
language interpretation or other Room 7, 31 Center Drive, Bethesda, MD [FR Doc. 2017–07509 Filed 4–12–17; 8:45 am]
reasonable accommodations, should 20892. BILLING CODE 4140–01–P
notify the Contact Person listed below Closed: 2:30 p.m. to 4:00 p.m.
in advance of the meeting. Agenda: To review and evaluate grant
applications. DEPARTMENT OF HEALTH AND
The meetings will be closed to the Place: National Institutes of Health, HUMAN SERVICES
public in accordance with the Building 31, C Wing, Conference Center,
provisions set forth in sections Room 7, 31 Center Drive, Bethesda, MD National Institutes of Health
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 20892.
as amended. The grant applications and Contact Person: Brent B. Stanfield, Ph.D.,
asabaliauskas on DSK3SPTVN1PROD with NOTICES

National Institute on Drug Abuse;
the discussions could disclose Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
Notice of Meeting
confidential trade secrets or commercial and Kidney Diseases, 6707 Democracy Blvd.,
property such as patentable material, Room 7323, MSC 5452, Bethesda, MD 20892, Pursuant to section 10(d) of the
and personal information concerning (301) 594–8843, stanfibr@niddk.nih.gov. Federal Advisory Committee Act, as
individuals associated with the grant Name of Committee: National Diabetes and amended (5 U.S.C. App.), notice is
applications, the disclosure of which Digestive and Kidney Diseases Advisory hereby given of a meeting of the
would constitute a clearly unwarranted Council, Diabetes, Endocrinology and National Advisory Council on Drug
invasion of personal privacy. Metabolic Diseases Subcommittee. Abuse.

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Document Created: 2017-04-13 01:09:27
Document Modified: 2017-04-13 01:09:27

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability; extension of comment period.
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.
Contact		Laura R. Epstein, Center for Veterinary Medicine (HFV-1), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-796-8558, [email protected]
FR Citation		82 FR 17844

82 FR 17844 - Regulation of Intentionally Altered Genomic DNA in Animals; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 70 (April 13, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration