Regulation of Intentionally Altered Genomic DNA in Animals; Extension of Comment Period, 17844-17845 [2017-07470]
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17844
Federal Register / Vol. 82, No. 70 / Thursday, April 13, 2017 / Notices
TABLE 1—CLASS I DEVICES—Continued
21 CFR section
886.4070
886.4070
886.4070
886.4070
886.4070
...........
...........
...........
...........
...........
Product
code
Device type
Engine, Trephine, Accessories, Gas-powered ................
Burr, Corneal, Battery-powered .......................................
Engine, Trephine, Accessories, Battery-powered ............
Engine, Trephine, Accessories, AC-powered ..................
Burr, Corneal, AC-powered ..............................................
Dated: April 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
HLD
HOG
HRF
HRG
HQS
HHS.
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’’).
Notice of availability; extension
of comment period.
Written/Paper Submissions
[FR Doc. 2017–07468 Filed 4–12–17; 8:45 am]
BILLING CODE 4164–01–P
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,
ACTION:
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draft guidance for industry (GFI) #187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period on the draft guidance published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:
SUMMARY:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
17:51 Apr 12, 2017
Jkt 241001
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
PO 00000
Frm 00051
Fmt 4703
Partial exemption limitation
(if applicable)
Sfmt 4703
‘‘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/201523389.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 90day 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
E:\FR\FM\13APN1.SGM
13APN1
Federal Register / Vol. 82, No. 70 / Thursday, April 13, 2017 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
asabaliauskas on DSK3SPTVN1PROD with NOTICES
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of meetings of the National
Diabetes and Digestive and Kidney
Diseases Advisory Council.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
VerDate Sep<11>2014
17:51 Apr 12, 2017
Jkt 241001
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council.
Date: May 10, 2017.
Open: 8:30 a.m. to 12:00 p.m.
Agenda: To present the Director’s Report
and other scientific presentations.
Place: National Institutes of Health,
Building 31, C Wing, Conference Room 10,
31 Center Drive, Bethesda, MD 20892.
Closed: 4:15 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, C Wing, Conference Room 10,
31 Center Drive, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd.,
Room 7323, MSC 5452 Bethesda, MD 20892,
(301) 594–8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council, Digestive Diseases and Nutrition
Subcommittee.
Date: May 10, 2017.
Open: 1:00 p.m. to 2:30 p.m.
Agenda: To review the Division’s scientific
and planning activities.
Place: National Institutes of Health,
Building 31, C Wing, Conference Center,
Room 6, 31 Center Drive, Bethesda, MD
20892.
Closed: 2:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, C Wing, Conference Center,
Room 6, 31 Center Drive, Bethesda, MD
20892.
Contact Person: Brent B. Stanfield, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd.,
Room 7323, MSC 5452, Bethesda, MD 20892,
(301) 594–8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council, Kidney, Urologic and Hematologic
Diseases Subcommittee.
Date: May 10, 2017.
Open: 1:00 p.m. to 2:15 p.m.
Agenda: To review the Division’s scientific
and planning activities.
Place: National Institutes of Health,
Building 31, C Wing, Conference Center,
Room 7, 31 Center Drive, Bethesda, MD
20892.
Closed: 2:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, C Wing, Conference Center,
Room 7, 31 Center Drive, Bethesda, MD
20892.
Contact Person: Brent B. Stanfield, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd.,
Room 7323, MSC 5452, Bethesda, MD 20892,
(301) 594–8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council, Diabetes, Endocrinology and
Metabolic Diseases Subcommittee.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
17845
Date: May 10, 2017.
Closed: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, C Wing, Conference Center,
Room 10, 31 Center Drive, Bethesda, MD
20892.
Open: 2:00 p.m. to 4:00 p.m.
Agenda: To review the Division’s scientific
and planning activities.
Place: National Institutes of Health,
Building 31, C Wing, Conference Center,
Room 10, 31 Center Drive, Bethesda, MD
20892.
Contact Person: Brent B. Stanfield, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd.,
Room 7323, MSC 5452, Bethesda, MD 20892,
(301) 594–8843, stanfibr@niddk.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page:
www.niddk.nih.gov/fund/divisions/DEA/
Council/coundesc.htm., where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: April 10, 2017.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–07509 Filed 4–12–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Council on Drug
Abuse.
E:\FR\FM\13APN1.SGM
13APN1
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[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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