82 FR 17840 - Genome Editing in New Plant Varieties Used for Foods; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 70 (April 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 70 (April 13, 2017)
| Page Range | 17840-17841 | |
| FR Document | 2017-07469 |
[Federal Register Volume 82, Number 70 (Thursday, April 13, 2017)] [Notices] [Pages 17840-17841] From the Federal Register Online [www.thefederalregister.org] [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.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: 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
![17840 Federal Register / Vol. 82, No. 70 / Thursday, April 13, 2017 / Notices
the following topics: demographic school year. This is the third and final children out of the study. In addition,
information; HIV and STD risk data collection of a four-year project that each student will be read verbal assent
behaviors; use of HIV and STD health includes three data collections; previous language that explains he or she may
services; experiences at school, data collections occurred in December choose not to take the questionnaire or
including school connectedness, 2014 and December 2016. Data may skip any questions in the
harassment and bullying, homophobia, collection points coincide with the questionnaire with no penalty.
support of Lesbian, Gay, Bisexual, approximate beginning, mid-way, and Participation is completely voluntary.
Transgender, and Queer (LGBTQ) end points of the PS13–1308 The estimated burden per response
students; sexual orientation; receipt of cooperative agreement. We anticipate ranges from 35–45 minutes. This
referral for HIV and STD prevention the final data collection will yield data variation in burden is due to the slight
health services; and health education. from up to 16,500 high school students variability in skip patterns that may
This data collection system involves in grades 9 through 12 at the selected occur with certain responses and
administration of a paper-and-pencil schools. Although some students may variations in the reading speed of
questionnaire to seven high schools that have completed the questionnaire in students. The burden estimate presented
are participating in the HIV/STD one or more of the previous years, this here is based on the assumption of a 40-
prevention project of a local education is not a longitudinal design and minute response time per response.
agency that is funded with support from individual student responses will not be Students will complete the
CDC’s PS13–1308 cooperative tracked across the years. No personally questionnaire only once under this
agreement. The questionnaire, the identifiable information will be approval. Annualizing the collection
Youth Health and School Climate collected. over one year results in an estimated
Questionnaire, will be administered to All students’ parents will receive annualized burden of 11,000 hours for
approximately 16,500 students across parental consent forms that provide respondents. There are no costs to
the seven schools in the 2017–2018 them with an opportunity to opt their respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
Students in grades 9–12 ................... Youth Health and School Climate 16,500 1 40/60 11,000
Questionnaire.
Total ........................................... ........................................................... ........................ ........................ ........................ 11,000
Leroy A. Richardson, through a notice that appeared in the www.regulations.gov will be posted to
Chief, Information Collection Review Office, Federal Register of January 19, 2017. the docket unchanged. Because your
Office of Scientific Integrity, Office of the We are taking this action in response to comment will be made public, you are
Associate Director for Science, Office of the requests for an extension to allow solely responsible for ensuring that your
Director, Centers for Disease Control and interested persons additional time to comment does not include any
Prevention. submit comments. confidential information that you or a
[FR Doc. 2017–07482 Filed 4–12–17; 8:45 am] third party may not wish to be posted,
DATES: We are extending the comment
BILLING CODE 4163–18–P
period on the notice that published such as medical information, your or
January 19, 2017 (82 FR 6564). Submit anyone else’s Social Security number, or
either electronic or written comments confidential business information, such
DEPARTMENT OF HEALTH AND as a manufacturing process. Please note
HUMAN SERVICES by June 19, 2017. Late, untimely filed
comments will not be considered. The that if you include your name, contact
Food and Drug Administration https://www.regulations.gov electronic information, or other information that
filing system will accept comments identifies you in the body of your
[Docket No. FDA–2016–N–4389] until midnight Eastern Time at the end comments, that information will be
of June 19, 2017. Comments received by posted on https://www.regulations.gov.
Genome Editing in New Plant Varieties mail/hand delivery/courier (for written/ • If you want to submit a comment
Used for Foods; Extension of paper submissions) will be considered with confidential information that you
Comment Period timely if they are postmarked or the do not wish to be made available to the
AGENCY: Food and Drug Administration, delivery service acceptance receipt is on public, submit the comment as a
HHS. or before that date. written/paper submission and in the
ADDRESSES: You may submit comments manner detailed (see ‘‘Written/Paper
Notification; extension of
ACTION:
as follows: Submissions’’ and ‘‘Instructions’’).
comment period.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Electronic Submissions Written/Paper Submissions
SUMMARY: The Food and Drug
Administration (FDA or we) is Submit electronic comments in the Submit written/paper submissions as
extending the comment period for a following way: follows:
docket to receive information and • Federal eRulemaking Portal: • Mail/Hand delivery/Courier (for
comments on the use of genome editing https://www.regulations.gov. Follow the written/paper submissions): Division of
techniques to produce new plant instructions for submitting comments. Dockets Management (HFA–305), Food
varieties that are used for human or Comments submitted electronically, and Drug Administration, 5630 Fishers
animal food. We established the docket including attachments, to https:// Lane, Rm. 1061, Rockville, MD 20852.
VerDate Sep<11>2014 17:51 Apr 12, 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\13APN1.SGM 13APN1](https://thefederalregister.org/doc/82_FR_17910/page/1.svg)
![Federal Register / Vol. 82, No. 70 / Thursday, April 13, 2017 / Notices 17841
• For written/paper comments FOR FURTHER INFORMATION CONTACT: ACTION: Notice.
submitted to the Division of Dockets Regarding human food issues: Jason
Management, FDA will post your Dietz, Center for Food Safety and SUMMARY: The Food and Drug
comment, as well as any attachments, Applied Nutrition (HFS–205), Food and Administration (FDA or Agency) has
except for information submitted, Drug Administration, 5001 Campus Dr., identified a list of class I devices that
marked and identified, as confidential, College Park, MD 20740, 240–402–2282. are now exempt from premarket
if submitted as detailed in Regarding animal food issues: notification requirements, subject to
‘‘Instructions.’’ Kathleen Jones, Center for Veterinary certain limitations. FDA is publishing
Instructions: All submissions received Medicine (HFV–220), Food and Drug this notice of that determination in
must include the Docket No. FDA 2016– Administration, 7519 Standish Pl., accordance with procedures established
N–4389 for ‘‘Genome Editing in New Rockville, MD 20855, 240–402–5938. by the 21st Century Cures Act. This
Plant Varieties Used for Foods.’’ SUPPLEMENTARY INFORMATION: In the notice represents FDA’s final
Received comments, those filed in a Federal Register of January 19, 2017, we determination with respect to the class
timely manner (see DATES), will be published a notice announcing the I devices included in this document.
placed in the docket and, except for establishment of a docket to receive FDA’s action will decrease regulatory
those submitted as ‘‘Confidential comments on the use of genome editing burdens on the medical device industry
Submissions,’’ publicly viewable at techniques to produce new plant and will eliminate private costs and
https://www.regulations.gov or at the varieties that are used for human or expenditures required to comply with
Division of Dockets Management animal food. We requested these certain Federal regulation.
between 9 a.m. and 4 p.m., Monday comments because we recognize that FOR FURTHER INFORMATION CONTACT:
through Friday. developers of new plant varieties, Bryce Bennett, Center for Devices and
• Confidential Submissions—To researchers, and other stakeholders may Radiological Health, Food and Drug
submit a comment with confidential have valuable factual information and Administration, 10903 New Hampshire
information that you do not wish to be data about foods derived from new plant Ave., Bldg. 66, Rm. 5244, Silver Spring,
made publicly available, submit your varieties produced using genome MD 20993, 301–348–1446, email:
comments only as a written/paper editing, which can help inform FDA’s Gregory.Bennett@fda.hhs.gov.
submission. You should submit two thinking for these specific products. The SUPPLEMENTARY INFORMATION:
copies total. One copy will include the notice also discussed the history of I. Background
information you claim to be confidential FDA’s thinking regarding these
with a heading or cover note that states products, our long history of Under section 513 of the Federal
‘‘THIS DOCUMENT CONTAINS consultations with developers, Food, Drug, and Cosmetic Act (the
CONFIDENTIAL INFORMATION.’’ We researchers, and other stakeholders, and FD&C Act) (21 U.S.C. 360c), FDA must
will review this copy, including the specific questions and issues for which classify devices into one of three
claimed confidential information, in our we invited comments. We provided a regulatory classes: Class I, class II, or
consideration of comments. The second 90-day comment period that was class III. FDA classification of a device
copy, which will have the claimed scheduled to end on April 19, 2017. is determined by the amount of
confidential information redacted/ We have received requests for a 60- regulation necessary to provide a
blacked out, will be available for public day extension of the comment period. reasonable assurance of safety and
viewing and posted on https:// The requests conveyed concern that the effectiveness. Under the Medical Device
www.regulations.gov. Submit both current 90-day comment period does Amendments of 1976 (1976
copies to the Division of Dockets not allow sufficient time to develop a amendments) (Pub. L. 94–295), and the
Management. If you do not wish your meaningful or thoughtful comments to Safe Medical Devices Act of 1990 (Pub.
name and contact information to be the questions and issues we presented L. 101–629), devices are classified into
made publicly available, you can in the notice. class I (general controls) if there is
provide this information on the cover We have considered the requests and information showing that the general
sheet and not in the body of your are extending the comment period for controls of the FD&C Act are sufficient
comments and you must identify this 60 days, until June 19, 2017. A 60-day to assure safety and effectiveness; into
information as ‘‘confidential.’’ Any extension allows more time for class II (special controls), if general
information marked as ‘‘confidential’’ interested persons to submit comments controls, by themselves, are insufficient
will not be disclosed except in to the docket on this issue. to provide reasonable assurance of
accordance with 21 CFR 10.20 and other Dated: April 7, 2017. safety and effectiveness, but there is
applicable disclosure law. For more Anna K. Abram,
sufficient information to establish
information about FDA’s posting of special controls to provide such
Deputy Commissioner for Policy, Planning,
comments to public dockets, see 80 FR Legislation, and Analysis.
assurance; and into class III (premarket
56469, September 18, 2015, or access approval), if there is insufficient
[FR Doc. 2017–07469 Filed 4–12–17; 8:45 am]
the information at: https://www.gpo.gov/ information to support classifying a
BILLING CODE 4164–01–P
fdsys/pkg/FR-2015-09-18/pdf/2015- device into class I or class II and the
23389.pdf. device is a life sustaining or life
Docket: For access to the docket to supporting device, or is for a use which
DEPARTMENT OF HEALTH AND
read background documents or the is of substantial importance in
HUMAN SERVICES
electronic and written/paper comments preventing impairment of human
asabaliauskas on DSK3SPTVN1PROD with NOTICES
received, go to https:// Food and Drug Administration health, or presents a potential
www.regulations.gov and insert the unreasonable risk of illness or injury.
docket number, found in brackets in the [Docket No. FDA–2017–N–1610] Most generic types of devices that
heading of this document, into the were on the market before the date of
Medical Devices; Exemptions From
‘‘Search’’ box and follow the prompts the 1976 amendments (May 28, 1976)
Premarket Notification: Class I Devices
and/or go to the Division of Dockets (generally referred to as preamendments
Management, 5630 Fishers Lane, Rm. AGENCY: Food and Drug Administration, devices) have been classified by FDA
1061, Rockville, MD 20852. HHS. under the procedures set forth in section
VerDate Sep<11>2014 17:51 Apr 12, 2017 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\13APN1.SGM 13APN1](https://thefederalregister.org/doc/82_FR_17910/page/2.svg)
Document Created: 2017-04-13 01:09:26
Document Modified: 2017-04-13 01:09:26
| 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 | Notification; extension of comment period. | |
| 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. | |
| 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. | |
| FR Citation | 82 FR 17840 |
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