[Federal Register: December 8, 2006 (Volume 71, Number 236)]
[Notices]
[Page 71151-71152]
[DOCID:fr08de06-71]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER06-1516-000; ER06-1516-001]

Notice of Issuance of Order; Mac Trading, Inc.

November 30, 2006.
    Mac Trading, Inc. (Mac Trading) filed an application for market-
based rate authority, with an accompanying rate schedule. The proposed
market-based rate schedule provides for the sale of energy and capacity
at market-based rates. Mac Trading also requested waivers of various
Commission regulations. In particular, Mac Trading requested that the
Commission grant blanket approval under 18 CFR Part 34 of all future
issuances of securities and assumptions of liability by Mac Trading.
    On November 28, 2006, pursuant to delegated authority, the
Director, Division of Tariffs and Market

Development--West, granted the requests for blanket approval under Part
34. The Director's order also stated that the Commission would publish
a separate notice in the Federal Register establishing a period of time
for the filing of protests. Accordingly, any person desiring to be
heard or to protest the blanket approvals of issuances of securities or
assumptions of liability by Mac Trading should file a motion to
intervene or protest with the Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426, in accordance with Rules 211
and 214 of the Commission's Rules of Practice and Procedure. 18 CFR
385.211, 385.214 (2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protest is December 28, 2006.
    Absent a request to be heard in opposition by the deadline above,
Mac Trading is authorized to issue securities and assume obligations or
liabilities as a guarantor, indorser, surety, or otherwise in respect
of any security of another person; provided that such issuance or
assumption is for some lawful object within the corporate purposes of
Mac Trading, compatible with the public interest, and is reasonably
necessary or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Mac Trading's issuance of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-20808 Filed 12-7-06; 8:45 am]

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[Federal Register: December 15, 2009 (Volume 74, Number 239)]
[Notices]
[Page 66391]
[DOCID:fr15de09-105]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Aviation Proceedings, Agreements Filed the Week Ending November
21, 2009

    The following Agreements were filed with the Department of
Transportation under Sections 412 and 414 of the Federal Aviation Act,
as amended (49 U.S.C. 1382 and 1384) and procedures governing
proceedings to enforce these provisions. Answers may be filed within 21
days after the filing of the application.

    Docket Number: OST-2009-0297.
    Date Filed: Novermber 16, 2009.
    Parties: Members of the International Air Transport Association.
    Subject: PTC COMP, Resolution 024e, Rules for Payment of Local
Currency Fares, (Memo 1552), Intended effective date: 15 December 2009.

Renee V. Wright,
Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. E9-29773 Filed 12-14-09; 8:45 am]

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[Federal Register: October 7, 2009 (Volume 74, Number 193)]
[Notices]
[Page 51601-51602]
[DOCID:fr07oc09-63]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0684; FRL-8436-1]

Receipt of Petition Requesting EPA to Suspend the Registration of
Rozol Prairie Dog Bait and Cancel Certain Application Sites; Opening of
Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is publishing for public comment a June 5, 2009 petition
from World Wildlife Fund (WWF) available in docket number EPA-HQ-OPP-
2009-0684, requesting that the Agency suspend the registration of the
chlorophacinone product, Rozol Prairie Dog Bait (EPA Reg. No. 7173-
286), and cancel certain application sites for the product.

DATES: Comments must be received on or before November 6, 2009.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0684, 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 Facility'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-
2009-0684. 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 at http://www.regulations.gov. 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<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dan Peacock, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-5407; fax 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, and may be of
interest to a wide range of stakeholders including: Environmental
groups; farmers; ranchers; State regulatory partners; other interested
Federal agencies; members of the public interested in the sale,
distribution, or use of pesticides; and other pesticide registrants and
pesticide users.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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. What Action is the Agency Taking?

     EPA is providing an opportunity for public comment on a petition
received from the World Wildlife Fund (WWF) that asks the Agency to
suspend the registration of Rozol Prairie Dog Bait (EPA Reg. No. 7173-
286) and cancel certain application sites for the product. This product
is currently registered for use to control black-tailed prairie dogs
and its active ingredient is the anticoagulant rodenticide
chlorophacinone.
     The primary basis for the petition is the potential effect of this
product on non-target species, including certain predators and
scavengers of the black-tailed prairie dog. Specifically, the petition
contends that the poisoning risks to non-target species from the use of
this product are unjustified, given the availability of alternative
products to control black-tailed prairie dogs. Petitioners request EPA
to require the completion of an Avian Reproduction Study before further
product use to control black-tailed prairie dogs is permitted. The
petition also asks EPA to initiate formal consultation, under section 7
of the Endangered Species Act, with the U.S. Fish and Wildlife Service
(FWS) regarding the registration of this product. Third, it requests
that EPA develop a memorandum of understanding with FWS to show how EPA
will promote the conservation of birds protected under the Migratory
Bird Treaty Act. Petitioners ask that EPA suspend the use of Rozol
Prairie Dog Bait while these activities are ongoing and also request
that the application of the product be prohibited in those counties
where black-footed ferrets are present.
     As additional background, EPA is providing a recent letters from
FWS and other interested parties expressing similar concerns about the
potential impact of Rozol Prairie Dog Bait on non-target wildlife
protected under the Endangered Species Act and the Migratory Bird
Treaty Act (available in the public docket accompanying this notice at
EPA-HQ-OPP-2009-0684).
     EPA regulates non-food use pesticides, such as Rozol Prairie Dog
Bait, under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). Under FIFRA, EPA registers a pesticide if it determines that
the use of the pesticide will not cause ``unreasonable adverse
effects'' to human health or the environment. This standard involves
risk-benefit balancing when risks exist above EPA's level of concern.
Both registration decision under section 3 of FIFRA and cancellation
decisions under section 6 of FIFRA depend on the outcome of adverse
effects determinations. If this adverse effects standard is not
satisfied, EPA may not register the pesticide and existing pesticides
are subject to cancelation. See FIFRA sections 3(c)(5) and 6(b).
     If EPA issues a notice of intent to cancel a pesticide
registration and further determines that a suspension of the
registration prior to the completion of the ensuing cancellation
proceedings is necessary to prevent an imminent hazard, EPA may take
steps to suspend the registration during the pendency of cancellation
proceedings, as described in section 6(c) of FIFRA. FIFRA defines an
``imminent hazard'' as a situation in which the continued use of a
pesticide, during the time required for a cancellation hearing, would
likely cause unreasonable adverse effects or will involve an
unreasonable hazard to the survival of a species listed as threatened
or endangered pursuant to the Endangered Species Act.
     WWF's petition requests both suspension of the registration for
Rozol Prairie Dog Bait and cancellation of certain application sites
for the product. EPA therefore anticipates that its response to the
petition will address its risk-benefit analysis for this pesticide. EPA
conducted such an analysis at the time it registered Rozol Prairie Dog
Bait under section 3 of FIFRA. For this notice, EPA has compiled a list
of topics relevant to EPA's risk-benefit balancing decision for Rozol
Prairie Dog Bait (available in the public docket accompanying this
topic at EPA-HQ-OPP-2009-0684). EPA is providing an opportunity for
public comment and the submission of additional information pertinent
to these topics (if any is available), as such information would
further assist the Agency in responding to the petition.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: September 24, 2009.
 Debra Edwards,
Director, Office of Pesticide Programs.

[FR Doc. E9-23932 Filed 10-6-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 83, Number 100 (Wednesday, May 23, 2018)]
[Notices]
[Pages 23918-23920]
[FR Doc No: 2018-10993]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1456]

Maximal Usage Trials for Topical Active Ingredients Being
Considered for Inclusion in an Over-the-Counter Monograph: Study
Elements and Considerations; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Maximal
Usage Trials for Topical Active Ingredients Being Considered for
Inclusion in an Over-the-Counter Monograph: Study Elements and
Considerations.'' This draft guidance addresses FDA's current thinking
on the conduct of in vivo absorption trials for topical active
ingredients that are under

consideration for inclusion in an over-the-counter (OTC) monograph.

DATES: Submit either electronic or written comments on the draft
guidance by July 23, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2018-D-1456 for ``Maximal Usage Trials for Topical Active
Ingredients Being Considered for Inclusion in an Over-the-Counter
Monograph: Study Elements and Considerations; Draft Guidance for
Industry.'' 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 Dockets Management Staff
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 Dockets Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993-0002, 240-
402-4246.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Maximal Usage Trials for Topical Active Ingredients Being
Considered for Inclusion in an Over-the-Counter Monograph: Study
Elements and Considerations.'' This draft guidance addresses the
current thinking of FDA on the conduct of in vivo absorption trials for
topical active ingredients that are under consideration for inclusion
in an OTC monograph. A Maximal Usage Trial (MUsT) is a standard
approach to assessing the in vivo bioavailability of topical drug
products. The methodology described in this draft guidance adapts MUsT
principles for active ingredients being considered for inclusion in an
OTC monograph. Because information from a MUsT can help identify the
potential for systemic exposure to a topically applied active
ingredient, such information can help inform an FDA determination of
whether additional safety data are needed to support a finding that an
OTC drug containing that active ingredient is generally recognized as
safe and effective for its intended use.
    This draft guidance was written in response to comments submitted
to Docket No. FDA-2015-D-4021 for the draft guidance entitled ``Over-
the-Counter Sunscreens: Safety and Effectiveness Data'' (80 FR 72975,
November 23, 2015) and the final guidance that replaced it, entitled
``Nonprescription Sunscreen Drug Products--Safety and Effectiveness
Data'' (81 FR 84594, November 23, 2016), requesting that FDA provide
further guidance and details on the MUsT. It provides additional
information on the study elements, data analysis, and considerations
when designing a MUsT for a topical active ingredient being considered
for inclusion in an OTC monograph.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Maximal
Usage Trials for Topical Active Ingredients Being Considered for
Inclusion in an Over-the-Counter Monograph: Study Elements and
Considerations.'' It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies

the requirements of the applicable statutes and regulations. This
guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance contains collections of information that are
exempt from the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520). Section 586D(a)(1)(C) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360fff-4(a)(1)(C)) as amended by the Sunscreen
Innovation Act states that the PRA shall not apply to collections of
information made for purposes of guidance under that subsection.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: May 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10993 Filed 5-22-18; 8:45 am]
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