Genome Editing in New Plant Varieties Used for Foods; Extension of Comment Period, 17840-17841 [2017-07469]
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Federal Register / Vol. 82, No. 70 / Thursday, April 13, 2017 / Notices
the following topics: demographic
information; HIV and STD risk
behaviors; use of HIV and STD health
services; experiences at school,
including school connectedness,
harassment and bullying, homophobia,
support of Lesbian, Gay, Bisexual,
Transgender, and Queer (LGBTQ)
students; sexual orientation; receipt of
referral for HIV and STD prevention
health services; and health education.
This data collection system involves
administration of a paper-and-pencil
questionnaire to seven high schools that
are participating in the HIV/STD
prevention project of a local education
agency that is funded with support from
CDC’s PS13–1308 cooperative
agreement. The questionnaire, the
Youth Health and School Climate
Questionnaire, will be administered to
approximately 16,500 students across
the seven schools in the 2017–2018
children out of the study. In addition,
each student will be read verbal assent
language that explains he or she may
choose not to take the questionnaire or
may skip any questions in the
questionnaire with no penalty.
Participation is completely voluntary.
The estimated burden per response
ranges from 35–45 minutes. This
variation in burden is due to the slight
variability in skip patterns that may
occur with certain responses and
variations in the reading speed of
students. The burden estimate presented
here is based on the assumption of a 40minute response time per response.
Students will complete the
questionnaire only once under this
approval. Annualizing the collection
over one year results in an estimated
annualized burden of 11,000 hours for
respondents. There are no costs to
respondents other than their time.
school year. This is the third and final
data collection of a four-year project that
includes three data collections; previous
data collections occurred in December
2014 and December 2016. Data
collection points coincide with the
approximate beginning, mid-way, and
end points of the PS13–1308
cooperative agreement. We anticipate
the final data collection will yield data
from up to 16,500 high school students
in grades 9 through 12 at the selected
schools. Although some students may
have completed the questionnaire in
one or more of the previous years, this
is not a longitudinal design and
individual student responses will not be
tracked across the years. No personally
identifiable information will be
collected.
All students’ parents will receive
parental consent forms that provide
them with an opportunity to opt their
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondents
Form name
Students in grades 9–12 ...................
Youth Health and School Climate
Questionnaire.
16,500
1
40/60
11,000
Total ...........................................
...........................................................
........................
........................
........................
11,000
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2017–07482 Filed 4–12–17; 8:45 am]
BILLING CODE 4163–18–P
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.
Notification; extension of
comment period.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ACTION:
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
SUMMARY:
VerDate Sep<11>2014
17:51 Apr 12, 2017
Jkt 241001
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:
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’’).
Electronic Submissions
Written/Paper 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://
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.
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
E:\FR\FM\13APN1.SGM
13APN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 82, No. 70 / Thursday, April 13, 2017 / Notices
• 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/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.
VerDate Sep<11>2014
17:51 Apr 12, 2017
Jkt 241001
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 60day 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1610]
Medical Devices; Exemptions From
Premarket Notification: Class I Devices
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
ACTION:
17841
Notice.
The Food and Drug
Administration (FDA or Agency) has
identified a list of class I devices that
are now exempt from premarket
notification requirements, subject to
certain limitations. FDA is publishing
this notice of that determination in
accordance with procedures established
by the 21st Century Cures Act. This
notice represents FDA’s final
determination with respect to the class
I devices included in this document.
FDA’s action will decrease regulatory
burdens on the medical device industry
and will eliminate private costs and
expenditures required to comply with
certain Federal regulation.
FOR FURTHER INFORMATION CONTACT:
Bryce Bennett, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5244, Silver Spring,
MD 20993, 301–348–1446, email:
Gregory.Bennett@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Under section 513 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c), FDA must
classify devices into one of three
regulatory classes: Class I, class II, or
class III. FDA classification of a device
is determined by the amount of
regulation necessary to provide a
reasonable assurance of safety and
effectiveness. Under the Medical Device
Amendments of 1976 (1976
amendments) (Pub. L. 94–295), and the
Safe Medical Devices Act of 1990 (Pub.
L. 101–629), devices are classified into
class I (general controls) if there is
information showing that the general
controls of the FD&C Act are sufficient
to assure safety and effectiveness; into
class II (special controls), if general
controls, by themselves, are insufficient
to provide reasonable assurance of
safety and effectiveness, but there is
sufficient information to establish
special controls to provide such
assurance; and into class III (premarket
approval), if there is insufficient
information to support classifying a
device into class I or class II and the
device is a life sustaining or life
supporting device, or is for a use which
is of substantial importance in
preventing impairment of human
health, or presents a potential
unreasonable risk of illness or injury.
Most generic types of devices that
were on the market before the date of
the 1976 amendments (May 28, 1976)
(generally referred to as preamendments
devices) have been classified by FDA
under the procedures set forth in section
E:\FR\FM\13APN1.SGM
13APN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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