[Federal Register: August 26, 2010 (Volume 75, Number 165)]
[Notices]
[Page 52605-52606]
[DOCID:fr26au10-125]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Veterinary Medicine Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Veterinary Medicine Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 19, 2010, from
1 p.m. to 5:30 p.m. and on September 20, 2010, from 8 a.m. until 6 p.m.
    Location: Rockville Hilton, 1750 Rockville Pike, Rockville, MD
20852,<PHONE_NUMBER>.
    Contact Person: Aleta Sindelar, Center for Veterinary Medicine
(HFV-3), Food and Drug Administration, 7519 Standish Pl., Rockville, MD
20855,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>or FDA Advisory Committee Information Line,
1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), code
3014512548. Please call the Information Line for up-to-date information
on this meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the Agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
    Agenda: On September 19, 2010, the committee will receive an
orientation on both general scientific issues surrounding genetically
engineered animals and the statutory and regulatory constraints under
which the Agency must operate. On September 20, 2010, the committee
will consider issues regarding the safety and effectiveness of the new
animal drug that is the subject of a new animal drug application (NADA)
concerning AquAdvantage salmon produced by AquaBounty Technologies,
Inc. These genetically engineered Atlantic salmon are intended to grow
faster than conventionally bred Atlantic salmon.
    Two background documents entitled ``An overview of Atlantic salmon,
its natural history, aquaculture, and genetic engineering'' and ``The
VMAC Meeting on Science-Based Issues Associated with AquAdvantage
Salmon'' can be found at http://www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/
ucm201810.htm.
    In a separate notice published elsewhere in this issue of the
Federal Register, FDA is announcing that it will hold a public hearing
on the labeling of food, including naming of the food, from the
AquAdvantage salmon on September 21, 2010. This public hearing will
allow the public to comment on the application of food labeling
principles to food from the AquAdvantage Salmon, if the NADA is
approved. An overview of the labeling issues to be addressed is
described in ``Background Document: Public Hearing before the
Commissioner on the Labeling of Food Made from the AquAdvantage
Salmon''  at http://www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/
ucm201810.htm.
    FDA anticipates making the meeting materials available
approximately 16 days before this meeting, but in any event no later
than 2 business days before the meeting at http://www.fda.gov/
AdvisoryCommittees/CommitteesMeetingMaterials/
VeterinaryMedicineAdvisoryCommittee/ucm201810.htm. If FDA is unable to
post the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting.
    Additional information regarding the Center for Veterinary
Medicine's (CVM's) regulatory oversight of genetically engineered
animals can be found at http://www.fda.gov/AnimalVeterinary/
DevelopmentApprovalProcess/GeneticEngineering/
GeneticallyEngineeredAnimals/default.htm.
    Please be advised that as soon as a transcript is available, it can
be obtained in either hardcopy or on CD-ROM, after submission of a
Freedom of Information request. Written requests are to be sent to the
Division of Freedom of

Information (HFI-35), Office of Management Programs, Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
September 16, 2010. Oral presentations from the public will be
scheduled between approximately 2:45 p.m. and 4 p.m. on September 20,
2010. Those desiring to make formal oral presentations should notify
the contact person and submit a brief statement of the general nature
of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
September 7, 2010. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by September 9,
2010.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Aleta Sindelar at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on publioc conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: August 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21245 Filed 8-25-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: June 20, 2007 (Volume 72, Number 118)]
[Notices]
[Page 34010-34011]
[DOCID:fr20jn07-90]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0404; FRL-8132-3]

Experimental Use Permit; Receipt of Application

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of an application 73049-EUP-U
from Valent BioSciences Corporation requesting an experimental use
permit (EUP) for the biochemical pesticide S-Abscisic Acid; (S)-5-(1-
hydroxy-2,6,6-trimethyl-4-oxo-1-cyclohex-2-enyl)-3-methyl-penta-
(2Z,4E)-dienoic Acid. The Agency has determined that the application
may be of regional and national significance. Therefore, in accordance
with 40 CFR 172.11(a), the Agency is soliciting comments on this
application.

DATES: Comments must be received on or before July 20, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0404, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0404. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Chris Pfeifer, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to those persons who are or may be required to
conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA) or the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). Since other entities may also be interested,
the Agency has not attempted to describe all the specific entities that
may be affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

    Valent BioSciences Corporation, 870 Technology Way, Libertyville,
IL 60048, has submitted an EUP application, 70349-EUP-U, for use of the
biochemical pesticide S-Abscisic Acid (ABA) on table and wine grapes.
As required with a food use, a ``Request for a Temporary Exemption from
the Requirement of a Tolerance'' was published in the Federal Register
on April 30, 2007 (72 FR 21263) (FRL-8124-7). The proposed active
ingredient is a well known plant growth regulator, and is expected to
enhance fruit coloring. ABA will be applied from two to three weeks
before harvest in one or two sprays of 50 to 200 parts per million
(ppm) each in a water volume of 75 to 200 gallons per acre. The
application proposes to treat 5,000 acres annually. Shipment/use dates
are expected to begin in August of 2008 and to continue until the
permit's proposed expiration in August of 2010. Participating states
include: California, Michigan, New York, Oregon, Texas, and Washington.

III. What Action is the Agency Taking?

    Following the review of the Valent Biosciences Corporation
application and any comments and data received in response to this
notice, EPA will decide whether to issue or deny the EUP request for
this EUP program, and if issued, the conditions under which it is to be
conducted. Any issuance of an EUP will be announced in the Federal
Register.

IV. What is the Agency's Authority for Taking this Action?

    The Agency's authority for taking this action is under FIFRA
section 5.

List of Subjects

    Environmental protection, Experimental use permits.

    Dated: June 6, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. E7-11521 Filed 6-19-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 77, Number 139 (Thursday, July 19, 2012)]
[Notices]
[Pages 42500-42501]
[FR Doc No: 2012-17554]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0230]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Examination of Online Direct-to-
Consumer Prescription Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Examination of Online Direct-to-
Consumer Prescription Drug Promotion'' has been approved by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of
1995.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On January 31, 2012, the Agency submitted a
proposed collection of information entitled ``Examination of Online
Direct-to-Consumer Prescription Drug

Promotion'' to OMB for review and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. OMB has now approved the information
collection and has assigned OMB control number 0910-0714. The approval
expires on July 31, 2015. A copy of the supporting statement for this
information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: July 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17554 Filed 7-18-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 122 (Monday, June 25, 2018)]
[Notices]
[Page 29589]
[FR Doc No: 2018-13484]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83463]

Draft 2018-2022 Strategic Plan for Securities and Exchange
Commission

AGENCY: Securities and Exchange Commission.

ACTION: Request for comment.

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SUMMARY: The Securities and Exchange Commission (SEC) is providing
notice that it is seeking comments on its draft 2018-2022 Strategic
Plan. The draft Strategic Plan includes a draft of the SEC's mission,
vision, values, strategic goals, and planned initiatives.

DATES: Comments should be received on or before July 25, 2018.

ADDRESSES: Comments may be submitted by any of the following methods:

Electronic Comments

    Send an email to [email protected].

Paper Comments

    Send paper comments to Nicole Puccio, Branch Chief, Securities and
Exchange Commission, 100 F Street NE, Washington, DC 20549-2521.

FOR FURTHER INFORMATION CONTACT: Nicole Puccio, Branch Chief, Office of
Financial Management, at<PHONE_NUMBER>, Securities and Exchange
Commission, 100 F Street NE, Washington, DC 20549-2521.

SUPPLEMENTARY INFORMATION: The draft strategic plan is available at the
Commission's website at https://www.sec.gov/files/sec-strategic-plan-2018-2022.pdf or by contacting Nicole Puccio, Branch Chief, Office of
Financial Management, at<PHONE_NUMBER>, Securities and Exchange
Commission, 100 F Street NE, Washington, DC 20549-2521.

    By the Commission.

    Dated: June 19, 2018.
Brent J. Fields,
Secretary.
[FR Doc. 2018-13484 Filed 6-22-18; 8:45 am]
 BILLING CODE 8011-01-P