81 FR 22092 - Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 72 (April 14, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 72 (April 14, 2016)
| Page Range | 22092-22093 | |
| FR Document | 2016-08678 |
[Federal Register Volume 81, Number 72 (Thursday, April 14, 2016)] [Notices] [Pages 22092-22093] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08678] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-2235] Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of March 14, 2016. In the notice, FDA requested comments on the Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the notice published March 14, 2016 (81 FR 13371). Submit either electronic or written comments by May 13, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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-2014-N-2235 for ``Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 [[Page 22093]] claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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. Submit written requests for single copies of the draft Environmental Assessment (EA) and preliminary Finding of No Significant Impact (FONSI) to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. Persons with access to the Internet may obtain the draft EA and preliminary FONSI at either http://www.fda.gov/animalveterinary/developmentapprovalprocess/environmentalassessments/ucm300656.htm or http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Brinda Dass, Center for Veterinary Medicine (HFV-2), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8247, email: [email protected]. SUPPLEMENTARY INFORMATION: In the Federal Register of March 16, 2016, FDA published a notice with a 30-day comment period to request comments on the Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes. The Agency has received requests for a 90-day extension of the comment period for the notice. Each request conveyed concern that the current 30-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the notice. FDA has considered the requests and is extending the comment period for the notice for 30 days, until May 13, 2016. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying the Agency's decision on whether to finalize these documents or prepare an Environmental Impact Statement. Dated: April 7, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-08678 Filed 4-13-16; 8:45 am] BILLING CODE 4164-01-P
![22092 Federal Register / Vol. 81, No. 72 / Thursday, April 14, 2016 / Notices
activities by Women of Color Network, resource sharing for the FVPSA state www.regulations.gov will be posted to
Inc. (WOCN). administrators, graduates and the docket unchanged. Because your
community-based organizations; comment will be made public, you are
SUMMARY: The Administration for evaluation and documentation of how solely responsible for ensuring that your
Children and Families (ACF), the technical assistance and processes comment does not include any
Administration on Children, Youth and improved the skills, access, engagement confidential information that you or a
Families (ACYF), Family and Youth and/or participation of the graduates, third party may not wish to be posted,
Services Bureau (FYSB), Division of state administrators and community- such as medical information, your or
Family Violence and Prevention based organizations. anyone else’s Social Security number, or
Services (DFVPS) announces the award confidential business information, such
Statutory Authority: Section 310 of the
of $175,000 as a single-source grant to as a manufacturing process. Please note
Family Violence Prevention and Services
the Pennsylvania Coalition Against Act, as amended by Section 201 of the that if you include your name, contact
Domestic Violence (PCADV) in CAPTA Reauthorization Act of 2010, Pub. L. information, or other information that
Harrisburg, PA, to support activities by 111–320. identifies you in the body of your
Women of Color Network Inc. (WOCN). comments, that information will be
The grantee, funded under the FVPSA Christopher Beach,
posted on http://www.regulations.gov.
program, is a technical assistance Senior Grants Policy Specialist, Office of • If you want to submit a comment
provider that assists FVPSA service Administration. with confidential information that you
providers to build the capacity of [FR Doc. 2016–08534 Filed 4–13–16; 8:45 am] do not wish to be made available to the
domestic violence programs. BILLING CODE 4184–32–P public, submit the comment as a
DATES: The period of support for the written/paper submission and in the
single-source program expansion manner detailed (see ‘‘Written/Paper
DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’).
supplement is September 30, 2015
HUMAN SERVICES
through September 29, 2016. Written/Paper Submissions
FOR FURTHER INFORMATION CONTACT: Food and Drug Administration Submit written/paper submissions as
Shena Williams, Senior Program follows:
Specialist, Family Violence Prevention [Docket No. FDA–2014–N–2235]
• Mail/Hand delivery/Courier (for
and Services Program, 330 C Street SW., Draft Environmental Assessment and written/paper submissions): Division of
Washington, DC 20201. Telephone: Preliminary Finding of No Significant Dockets Management (HFA–305), Food
202–205–5932; Email: Shena.Williams@ Impact Concerning Investigational Use and Drug Administration, 5630 Fishers
acf.hhs.gov. of Oxitec OX513A Mosquitoes; Lane, Rm. 1061, Rockville, MD 20852.
SUPPLEMENTARY INFORMATION: Grant Extension of Comment Period • For written/paper comments
funds will support WOCN, through the submitted to the Division of Dockets
PCADV, to provide training and AGENCY: Food and Drug Administration, Management, FDA will post your
technical assistance to individuals and HHS. comment, as well as any attachments,
organizations dedicated to enhancing ACTION: Notice; extension of comment except for information submitted,
services to those in historically period. marked and identified, as confidential,
marginalized communities in domestic if submitted as detailed in
violence programs across the country. SUMMARY: The Food and Drug ‘‘Instructions.’’
The WOCN will provide technical Administration (FDA) is extending the Instructions: All submissions received
assistance and training to FVPSA state comment period for the notice that must include the Docket No. FDA–
administrators to strengthen appeared in the Federal Register of 2014–N–2235 for ‘‘Draft Environmental
collaborative efforts of state March 14, 2016. In the notice, FDA Assessment and Preliminary Finding of
administrators and community-based requested comments on the Draft No Significant Impact Concerning
organizations for the purposes of Environmental Assessment and Investigational Use of Oxitec OX513A
improving services to victims of Preliminary Finding of No Significant Mosquitoes.’’ Received comments will
domestic violence in diverse and Impact Concerning Investigational Use be placed in the docket and, except for
historically marginalized communities. of Oxitec OX513A Mosquitoes. The those submitted as ‘‘Confidential
This project may include such Agency is taking this action in response Submissions,’’ publicly viewable at
activities as listening sessions to to requests for an extension to allow http://www.regulations.gov or at the
identify specific needs, challenges and interested persons additional time to Division of Dockets Management
barriers to funding, services and submit comments. between 9 a.m. and 4 p.m., Monday
collaborative efforts; documentation of DATES: FDA is extending the comment through Friday.
technical assistance needs; and period on the notice published March • Confidential Submissions—To
development of state-specific technical 14, 2016 (81 FR 13371). Submit either submit a comment with confidential
assistance plans and written electronic or written comments by May information that you do not wish to be
recommendations for fostering and 13, 2016. made publicly available, submit your
sustaining collaborative partnerships ADDRESSES: You may submit comments comments only as a written/paper
and capacity-building activities. as follows: submission. You should submit two
In addition to the issue of capacity- copies total. One copy will include the
Electronic Submissions
mstockstill on DSK4VPTVN1PROD with NOTICES
building activities, the grantee will information you claim to be confidential
provide support and training to address Submit electronic comments in the with a heading or cover note that states
the identified barriers including gaps in following way: ‘‘THIS DOCUMENT CONTAINS
leadership development. Training will • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The
include such activities as targeted www.regulations.gov. Follow the Agency will review this copy, including
technical assistance for state instructions for submitting comments. the claimed confidential information, in
administrators, graduates and Comments submitted electronically, its consideration of comments. The
community-based organizations; including attachments, to http:// second copy, which will have the
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![Federal Register / Vol. 81, No. 72 / Thursday, April 14, 2016 / Notices 22093
claimed confidential information period for the notice. Each request Open: May 4, 2016.
redacted/blacked out, will be available conveyed concern that the current 30- Time: 8:30 a.m. to 4:00 p.m.
for public viewing and posted on day comment period does not allow Agenda: This portion of the meeting will
be open to the public for announcements and
http://www.regulations.gov. Submit sufficient time to develop a meaningful
reports of administrative, legislative, and
both copies to the Division of Dockets or thoughtful response to the notice. program developments in the drug abuse
Management. If you do not wish your FDA has considered the requests and field.
name and contact information to be is extending the comment period for the Place: National Institutes of Health,
made publicly available, you can notice for 30 days, until May 13, 2016. Neuroscience Center, 6001 Executive
provide this information on the cover The Agency believes that a 30-day Boulevard, Rockville, MD 20852.
sheet and not in the body of your extension allows adequate time for Contact Person: Susan R.B. Weiss, Ph.D.,
interested persons to submit comments Director, Division of Extramural Research,
comments and you must identify this
without significantly delaying the Office of the Director, National Institute on
information as ‘‘confidential.’’ Any Drug Abuse, NIH, DHHS, 6001 Executive
information marked as ‘‘confidential’’ Agency’s decision on whether to Boulevard, NSC, Room 5274, MSC 9591,
will not be disclosed except in finalize these documents or prepare an Rockville, MD 20892, 301–443–6487,
accordance with 21 CFR 10.20 and other Environmental Impact Statement. sweiss@nida.nih.gov.
applicable disclosure law. For more Dated: April 7, 2016. Any member of the public interested in
information about FDA’s posting of Leslie Kux, presenting oral comments to the committee
comments to public dockets, see 80 FR may notify the Contact Person listed on this
Associate Commissioner for Policy.
56469, September 18, 2015, or access notice at least 10 days in advance of the
[FR Doc. 2016–08678 Filed 4–13–16; 8:45 am] meeting. Interested individuals and
the information at: http://www.fda.gov/ BILLING CODE 4164–01–P representatives of organizations may submit
regulatoryinformation/dockets/ a letter of intent, a brief description of the
default.htm. organization represented, and a short
Docket: For access to the docket to DEPARTMENT OF HEALTH AND description of the oral presentation. Only one
read background documents or the HUMAN SERVICES representative of an organization may be
electronic and written/paper comments allowed to present oral comments and if
received, go to http:// National Institutes of Health accepted by the committee, presentations
www.regulations.gov and insert the may be limited to five minutes. Both printed
National Institute on Drug Abuse; and electronic copies are requested for the
docket number, found in brackets in the
Notice of Meeting record. In addition, any interested person
heading of this document, into the may file written comments with the
‘‘Search’’ box and follow the prompts Pursuant to section 10(d) of the committee by forwarding their statement to
and/or go to the Division of Dockets Federal Advisory Committee Act, as the Contact Person listed on this notice. The
Management, 5630 Fishers Lane, Rm. amended (5 U.S.C. App.), notice is statement should include the name, address,
1061, Rockville, MD 20852. telephone number and when applicable, the
hereby given of a meeting of the
Submit written requests for single business or professional affiliation of the
National Advisory Council on Drug interested person.
copies of the draft Environmental Abuse.
Assessment (EA) and preliminary Information is also available on the
The meeting will be open to the Institute’s/Center’s home page:
Finding of No Significant Impact public as indicated below, with www.drugabuse.gov/NACDA/
(FONSI) to the Policy and Regulations attendance limited to space available. NACDAHome.html, where an agenda and
Staff (HFV–6), Center for Veterinary Individuals who plan to attend and any additional information for the meeting
Medicine, Food and Drug need special assistance, such as sign will be posted when available.
Administration, 7519 Standish Pl., language interpretation or other (Catalogue of Federal Domestic Assistance
Rockville, MD 20855. Send one self- reasonable accommodations, should Program Nos.: 93.279, Drug Abuse and
addressed adhesive label to assist that notify the Contact Person listed below Addiction Research Programs, National
office in processing your requests. in advance of the meeting. Institutes of Health, HHS)
Persons with access to the Internet may The meeting will be closed to the Dated: April 8, 2016.
obtain the draft EA and preliminary public in accordance with the Natasha M. Copeland,
FONSI at either http://www.fda.gov/ provisions set forth in sections Program Analyst, Office of Federal Advisory
animalveterinary/developmentapproval 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Committee Policy.
process/environmentalassessments/ as amended. The grant applications [FR Doc. 2016–08523 Filed 4–13–16; 8:45 am]
ucm300656.htm or http:// and/or contract proposals and the BILLING CODE 4140–01–P
www.regulations.gov. discussions could disclose confidential
FOR FURTHER INFORMATION CONTACT: trade secrets or commercial property
Brinda Dass, Center for Veterinary such as patentable material, and DEPARTMENT OF HOMELAND
Medicine (HFV–2), Food and Drug personal information concerning SECURITY
Administration, 7500 Standish Pl., individuals associated with the grant
Rockville, MD 20855, 240–276–8247, applications and/or contract proposals, Transportation Security Administration
email: abig@fda.hhs.gov. the disclosure of which would
SUPPLEMENTARY INFORMATION: In the constitute a clearly unwarranted Intent To Request Renewal From OMB
Federal Register of March 16, 2016, invasion of personal privacy. of One Current Public Collection of
FDA published a notice with a 30-day Name of Committee: National Advisory Information: Baseline Assessment for
Security Enhancement (BASE)
mstockstill on DSK4VPTVN1PROD with NOTICES
comment period to request comments Council on Drug Abuse.
on the Draft Environmental Assessment Date: May 3–4, 2016. Program
and Preliminary Finding of No Closed: May 3, 2016.
Time: 2:00 p.m. to 4:00 p.m. AGENCY: Transportation Security
Significant Impact Concerning Agenda: To review and evaluate grant Administration, DHS.
Investigational Use of Oxitec OX513A applications and/or proposals. ACTION: 60-Day notice.
Mosquitoes. Place: National Institutes of Health,
The Agency has received requests for Neuroscience Center, 6001 Executive SUMMARY: The Transportation Security
a 90-day extension of the comment Boulevard, Rockville, MD 20852. Administration (TSA) invites public
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Document Created: 2018-02-07 13:48:24
Document Modified: 2018-02-07 13:48:24
| 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; extension of comment period. | |
| Dates | FDA is extending the comment period on the notice published March 14, 2016 (81 FR 13371). Submit either electronic or written comments by May 13, 2016. | |
| Contact | Brinda Dass, Center for Veterinary Medicine (HFV-2), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8247, email: [email protected] | |
| FR Citation | 81 FR 22092 |
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