The Congressional Review Act, (5 U.S.C. 801 et seq.), as added by
the Small Business Regulatory Enforcement Fairness Act of 1996, does
not apply because this action is not a rule for purposes of 5 U.S.C.
804(3).

X. References

    1. NRDC comments to IRED and petition to cancel registrations dated
January 10, 2005.
    2. NRDC petition to cancel carbaryl registrations submitted as part
of NRDC's comments to N-methyl carbamate NMC cumulative dated September
24, 2007.
    3. USEPA. 2000a. ``Choosing a Percentile of Acute Dietary Exposure
as a Threshold of Regulatory Concern.'' March 16, 2000. Available at:
http://www.epa.gov/pesticides/trac/science/trac2b054.pdf
    4. US EPA Office of Pesticide Programs. 1998. Proposed Methods for
Basin-Scale Estimation of Pesticide Concentrations in Flowing Water and
Reservoirs for Tolerance Reassessment. Presentation to the FIFRA SAP,
July 29, 1998.
    5. US EPA Office of Pesticide Programs. 1999. Proposed Methods for
Determining Watershed-derived Percent Crop Areas and Consideration for
Applying Crop Area Adjustments to

Surface Water Screening Models. Presentation to the FIFRA SAP, May 27,
1999.
    6. US EPA. Office of Pesticide Programs. 1997. Standard Operating
Procedures (SOPs) for Residential Exposure Assessments (Draft December
19, 1997).
    7. US EPA Office of Pesticide Programs. 2001. Science Advisory
Council for Exposure (ExpoSAC) Policy 12: Recommended Revisions to the
Standard Operating Procedures (SOPs) for Residential Exposure
Assessments. February 2001.
    8. US EPA Office of Pesticide Programs. 2002a. ExpoSAC Policy 13:
Postapplication Exposure Assessment for Children from Pet Treatments.
January 2002.
    9. US EPA Office of Pesticide Programs. 2002b. Office of Pesticide
Programs' Policy on the Determination of the Appropriate FQPA Safety
Factor(s) for Use in Tolerance Assessment. Available at http://
www.epa.gov/oppfead1/trac/science/determ.pdf.
    10. US EPA Office of Pesticide Programs. 2002c. Carbaryl: Updated
Toxicology Chapter for RED. May 24, 2002. See docket ID EPA-HQ-OPP-
2002-0138.
    11. US EPA Office of Pesticide Programs. 2000b. The Use of Data on
Cholinesterase Inhibition for Risk Assessments of Organophosphorous and
Carbamate Pesticides (August 18, 2000).
    12. US EPA. Office of Research and Development. 2000. Benchmark
Dose Technical Guidance Document. Draft report. Risk Assessment Forum,
Office of Research and Development, U.S. Environmental Protection
Agency. Washington, DC. EPA/630/R-00/001.
    13. FIFRA Science Advisory Panel. 2002. Methods Used to Conduct a
Preliminary Cumulative Risk Assessment for Organophosphate Pesticides.
Final Report from the FIFRA Scientific Advisory Panel Meeting of
February 5-7, 2002 (Report dated March 19, 2002). FIFRA Scientific
Advisory Panel, Office of Science Coordination and Policy, Office of
Prevention, Pesticides and Toxic Substances, U.S. Environmental
Protection Agency. Washington, DC. SAP Report 2002-01.
    14. FIFRA Science Advisory Panel. 2005a. Final report on N-Methyl
Carbamate Cumulative Risk Assessment: Pilot Cumulative Analysis. Final
Report from the FIFRA Scientific Advisory Panel Meeting of February ,
2005 (Report dated September 2, 1998). Available at: http://
www.epa.gov/scipoly/sap/2005/february/minutes.pdf.
    15. FIFRA Science Advisory Panel. 2005b. Final report on
Preliminary N-Methyl Carbamate Cumulative Risk Assessment. Final Report
from the FIFRA Scientific Advisory Panel Meeting of July 29-30, 2005
(Report dated September -, 2005). Available at: http://www.epa.gov/
scipoly/sap/2005/august/minutes.pdf.
    16. US EPA Office of Pesticide Programs. 2004. Interim
Reregistration Eligibility Decision for Carbaryl. (October 22, 2004).
    17. US EPA Office of Pesticide Programs. March 9, 2005 letter to
Peg Cherney, Bayer Crop Science, Final Cancellation Order for Carbaryl
Liquid Broadcast Application to Lawns/Turf; EPA Registration Numbers
264-324, 264-325, and 264-328.
    18. US EPA Office of Pesticide Programs. 2007. Office of
Prevention, Pesticides and Toxic Substances, EPA, Reregistration
Eligibility Decision for Carbaryl (September 24, 2007).
    19. BayerCropScience, Comments of BayerCropScience on the Petition
to Revoke or Modify Tolerances Established for Carbaryl. May 31, 2005.
    20. US EPA Office of Pesticide Programs. 2007. Carbaryl Refined
Drinking Water Time Series Simulations Using Regional PCAs (March 13,
2007).
    21. UP3 2007. Pesticides in Urban Surface Water. Urban Uses Trends
Annual Report, available at http://www.up3project.org/documents/FInal_
UP3_Use_Report_2007.pdf.
    22. USEPA Office of Pesticide Programs. Report of the FIFRA SAP
Meeting held April 30 to May 1, 2002. A Set of Scientific Issues Being
Considered by the EPA regarding CARES model review. June 13. 2002. EPA
SAP 2002-02.
    23. US EPA. Office of Research and Development. 2007. Report on
Comparative Cholinesterase Study of Carbaryl May 7, 2007).
    24. US EPA Office of Pesticide Programs. 2007. Carbaryl: Updated
Endpoint Selection for Single Chemical Risk Assessment (June 29, 2007).
    25. Padilla S, Setzer W, Marshall RS, et al. 2007. Time Course of
cholinesterase inhibition in adult rats treated acutely with carbaryl,
carbofuran, formetanate, methonmy, methiocarb, oxamyl, or propoxur.
Toxicology and Applied Pharmacology 219: 202-209.
    26. US EPA Office of Pesticide Programs. 2007. Carbaryl: Review of
in vitro Dermal Absorption Study (MRID 47151902). June 28, 2007.
    27. US EPA Office of Pesticide Programs. 2007. Carbaryl: Revisions
to Residential Exposure and Risk Assessment. June 29, 2007.
    28. US EPA Office of Pesticide Programs. 1999. Overview of Issues
Related to the Standard Operating Proceedures for Residential Exposure
Assessment. Presented to the FIFRA SAP on September 21, 1999.
    29. US EPA Office of Pesticide Programs. 2007. Revised N-methyl
Carbamate Cumulative Risk Assessment. September 24, 2007. (EPA-HQ-OPP-
2007-0935-0003).
    30. Freeman, N. C. G., Jimenez, M., Reed, K. J., Gurunathan, S.,
Edwards, R. D., & Lioy, P. J. 2001. Quantitative Analysis of Children's
Microactivity Patterns: The Minnesota Children's Pesticide Exposure
Study. Journal of Exposure Analysis and Environmental Epidemiology.
11(6): 501-509.
    31. Geno PW, Camann DE, Harding, HJ, Villalobos K, Lewis RG. 1995.
Handwipe Sampling and Analysis Procedure for the Measurement of Dermal
Contact with Pesticides. Arch Environ Contam Toxicol. 30:132-138.
    32. Fenske R. and C. Lu. 1994. Determination of Handwash Removal
Efficiency: Incomplete Removal of the Pesticide Chlorpyrifos from Skin
by Standard Handwash Techniques. American Industrial Hygiene
Association Journal. 55(5): 425-432.
    33. Wester RC, and Maibach HI. 1989. Dermal Decontamination and
Percutaneous Absorption. In: Percutaneous Absorption. 2nd ed. R.
Bronaugh and H.I. Maibach, editors. New York: Marcel Dekker, pp 335-
342.

List of Subjects in 40 CFR Part 180

    Environmental protection, Carbaryl, Pesticides and pest.

    Dated: September 30, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.

[FR Doc. E8-25693 Filed 10-28-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Notices]
[Page 28861]
[FR Doc No: 2016-10909]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IN12-17-000]

Total Gas & Power North America, Aaron Hall and Therese Tran f/k/
a/Nguyen; Notice of Designation of Commission Staff as Non-Decisional

    With respect to an order issued by the Commission on April 28, 2016
in the above-captioned docket,\1\ with the exceptions noted below, the
staff of the Office of Enforcement are designated as non-decisional in
deliberations by the Commission in this docket. Accordingly, pursuant
to 18 CFR 385.2202 (2015), they will not serve as advisors to the
Commission or take part in the Commission's review of any offer of
settlement. Likewise, as non-decisional staff, pursuant to 18 CFR
385.2201 (2015), they are prohibited from communicating with advisory
staff concerning any deliberations in this docket.
---------------------------------------------------------------------------

    \1\ Total Gas & Power North America, Aaron Hall and Therese Tran
f/k/a Nguyen, 155 FERC ] 61,105 (2016).
---------------------------------------------------------------------------

    Exceptions to this designation as non-decisional are:

Demetra Anas
John Carnes
Taylor Martin
Lisa Owings
Eric Primosch
Felice Richter
Emily Scruggs
Derek Shiau
Andrew Tamayo
David Zlotnick

    Dated: April 28, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-10909 Filed 5-9-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 212 (Friday, November 1, 2013)]
[Proposed Rules]
[Pages 65588-65589]
[FR Doc No: 2013-26056]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2013-N-0001]

Medical Gas Regulation Review; Announcement of Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA) is announcing a public
meeting on whether any changes to Federal drug regulations are
necessary for medical gases. The topic to be discussed is whether any
changes to the Federal drug regulations are necessary for medical gases
as part of the implementation of the Food and Drug Administration
Safety and Innovation Act (FDASIA).
    Date and Time: The meeting will be held on December 6, 2013, from 9
a.m. to 5 p.m. However, depending on the level of public participation,
the meeting may be extended or may end early.
    Location: The meeting will be held at FDA's White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.
1503A), Silver Spring, MD 20993-0002. The FDA Conference Center at the
White Oak location is a Federal facility with security procedures and
limited seating (please note that all visitors to the White Oak Campus
must enter through Building 1). The meeting is free and seating will be
on a first-come, first-served basis. Attendees who do not wish to make
an oral presentation do not need to register.
    Contact Persons: Mary Gross, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20903-0002,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>or Christine Kirk, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20903-0002,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>or Urvi Desai, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, email<EMAIL_ADDRESS>    Registration and Requests for Oral Presentations: If you wish to a
make an oral presentation, you must register by submitting your name,
title, firm name, address, telephone, email address, and FAX number, to
Mary Gross (see Contact Persons) by December 2, 2013. Please also
provide the type of organization you represent (e.g., industry,
consumer organization), and a brief summary of your remarks (including
the discussion topic(s) that will be addressed).
    FDA will try to accommodate all persons who wish to make a
presentation; however, the duration of each speaker's presentation may
be limited by time constraints. FDA will notify registered presenters
of their scheduled presentation times. Persons registered to speak
should check in before the meeting and are encouraged to arrive early
to ensure their designated order of presentation. Participants who are
not present when called may not be permitted to speak at a later time.
An agenda of the meeting will be made available at least 3 days before
the meeting at http://www.fda.gov/Drugs/NewEvents/ucm370351.htm.
    This public meeting will be Webcast and the URL will be posted at
http://www.fda.gov/Drugs/NewEvents/ucm370351.htm at least 1 day before
the meeting. A video record of the public meeting will be available at
the same Web site address for 1 year. If you need special
accommodations because of disability, please contact Mary Gross (see
Contact Persons) at least 7 days in advance.

    Comments: Regardless of attendance at the public meeting,
interested persons may submit electronic comments to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5600 Fishers Lane,
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. Identify comments with Docket No. FDA-2013-N-0260, which has
previously been established to accept comments regarding this issue. In
order to receive consideration in advance of the delivery of the report
(discussed further in this document), comments must be received by
December 16, 2013. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Send written
requests to the Division of Freedom of Information (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857.

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, President Obama signed FDASIA (Pub. L. 112-144)
into law. Section 1112(a) of FDASIA provides that not later than 18
months after its enactment, the Secretary, after obtaining input from
medical gas manufacturers and any other interested members of the
public, shall determine whether any changes to the Federal drug
regulations are necessary for medical gases and submit a report
regarding any such changes to the Committee on Health, Education,
Labor, and Pensions of the U.S. Senate and the Committee on Energy and
Commerce of the U.S. House of Representatives. Section 1112(c)(1)
defines ``Federal drug regulations'' to mean ``regulations in title 21
of the Code of Federal Regulations pertaining to drugs.'' Section
1112(b) provides that if the Secretary determines that changes to the
Federal drug regulations are necessary for medical gases, the Secretary
shall issue final regulations revising the Federal drug regulations
with respect to medical gases not later than 48 months after the
enactment of FDASIA.
    On March 22, 2013, FDA issued a Federal Register notice (78 FR
17611), which established a public docket (Docket No. FDA-2013-N-0260)
to request comments from medical gas manufacturers and any other
interested members of the public on whether any changes to Federal drug
regulations are necessary for medical gases.

II. Purpose and Scope of the Meeting

    We are holding this meeting to provide an additional opportunity
for medical gas manufacturers and any other interested members of the
public to provide input on whether any changes to Federal drug
regulations are needed for medical gases.

    Dated: October 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26056 Filed 10-31-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 7 (Tuesday, January 12, 2016)]
[Notices]
[Pages 1428-1429]
[FR Doc No: 2016-00326]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0977]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To Protect Children and Adolescents

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on regulations restricting the
sale and distribution of cigarettes and smokeless tobacco to protect
children and adolescents.

DATES: Submit either electronic or written comments on the collection
of information by March 14, 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-2012-N-0977 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Regulations Restricting the Sale
and Distribution of Cigarettes and Smokeless Tobacco to Protect
Children and Adolescents.'' 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
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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco to Protect Children and Adolescents--21 CFR 1140

OMB Control Number 0910-0312--Extension

    This is a request for an extension of OMB approval for the
information collection requirements contained in FDA's regulations for
cigarettes and smokeless tobacco containing nicotine. The regulations
that are codified at 21 CFR part 1140 are authorized by section 102 of
the Family Smoking Prevention and Tobacco Control Act (Tobacco Control
Act) (Pub. L. 111-31). Section 102 of the Tobacco Control Act required
FDA to publish a final rule regarding cigarettes and smokeless tobacco
identical in its provisions to the regulation issued by FDA in 1996 (61
FR 44396, August 28, 1996), with certain specified exceptions including
that subpart C (which included Sec.  897.24) and Sec.  897.32(c) be
removed from the reissued rule (section 102(a)(2)(B)). The reissued
final rule was published in the Federal Register of March 19, 2010 (75
FR 13225).
    This collection includes reporting information requirements for
Sec.  1140.30 which directs persons to notify FDA if they intend to use
a form of advertising that is not addressed in the regulations. The
requirements are as follows:

------------------------------------------------------------------------

------------------------------------------------------------------------
21 CFR 1140.30................  Reporting........  Directs persons to
                                                    notify FDA if they
                                                    intend to use a form
                                                    of advertising that
                                                    is not originally
                                                    described in the
                                                    March 19, 2010,
                                                    final rule.
------------------------------------------------------------------------

    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR section                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1140.30 (Scope of Permissible Forms of Labeling and Advertising)...             300                1              300                1              300
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden hour estimates for this collection of information were
based on industry-prepared data and information regarding cigarette and
smokeless tobacco product advertising expenditures.
    Section 1140.30 requires manufacturers, distributors, and
retailers: (1) To observe certain format and content requirements for
labeling and advertising, and (2) to notify FDA if they intend to use
an advertising medium that is not listed in the regulations. The
concept of permitted advertising in Sec.  1140.30 is sufficiently broad
to encompass most forms of advertising. FDA estimates that
approximately 300 respondents will submit an annual notice of
alternative advertising, and the Agency has estimated it should take 1
hour to provide such notice. Therefore, FDA estimates that the total
time required for this collection of information is 300 hours.

    Dated: January 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00326 Filed 1-11-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 9, 2008 (Volume 73, Number 132)]
[Rules and Regulations]
[Page 39247-39251]
[DOCID:fr09jy08-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0871; FRL-8370-2]

Flumioxazin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of
flumioxazin in or on corn, field grain; corn, field forage; and corn,
field stover. Valent U.S.A. Corporation requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 9, 2008. Objections and
requests for hearings must be received on or before September 8, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0871. 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. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (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 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 Docket Facility is open 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: Joanne I. Miller, Registration
Division (7505P), 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?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide 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. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0871 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before September 8, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0871, 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>.

II. Petition for Tolerance

    In the Federal Register of September 28, 2007 (72 FR 55204) (FRL-
8147-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F7243) by Valent U.S.A. Corporation, 1600 Riviera Avenue, Suite 200,
Walnut Creek, CA 94596. The petition requested that 40 CFR 180.568 be
amended by establishing tolerances for residues of the herbicide
flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-
benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or
on corn, field grain; corn, field forage; and corn, field stover at
0.02 parts per million (ppm). That notice referenced a summary of the
petition prepared by Valent U.S.A. Corporation, the registrant, which
is available to the public in the docket, http://www.regulations.gov.
There were no comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of flumioxazin on corn, field grain; corn,
field forage; and corn, field stover at 0.02 ppm. EPA's assessment of
exposures and risks associated with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Flumioxazin has mild or no acute toxicity when administered orally,
dermally, or by inhalation. It has little or no toxicity with regard to
eye irritation or skin irritation and is not a dermal sensitizer.
Subchronic and chronic toxicity studies demonstrated that the target
organs of flumioxazin are the liver, spleen and cardiovascular system.
Developmental effects were observed in developmental rat studies. These
effects were fetal cardiovascular anomalies (especially ventricular
septal defects). Flumioxazin has been classified as a ``Not Likely
Human Carcinogen,'' based on the lack of carcinogenicity in a 2-year
rat study, an 18-month mouse study, and a battery of mutagenic studies.
    Specific information on the studies received and the nature of the
adverse effects caused by flumioxazin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document ``Flumioxazin; Human Health Risk
Assessment for the Proposed Food Use on Field Corn,'' at page 39 in
docket ID number EPA-HQ-OPP-2007-0871.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the NOAEL in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the LOAEL or a Benchmark Dose (BMD)
approach is sometimes used for risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction with the POD to take into account
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in the variations in sensitivity among members of the
human population as well as other unknowns. Safety is assessed for
acute and chronic dietary risks by comparing aggregate food and water
exposure to the pesticide to the acute population adjusted dose (aPAD)
and chronic population adjusted dose (cPAD). The aPAD and cPAD are
calculated by dividing the POD by all applicable UFs. Aggregate short-
term, intermediate-term, and chronic-term risks are evaluated by
comparing food, water, and residential exposure to the POD to ensure
that the margin of exposure (MOE) called for by the product of all
applicable UFs is not exceeded. This latter value is referred to as the
Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for flumioxazin used for
human risk assessment can be found at http://www.regulations.gov in
document ``Flumioxazin; Human Health Risk Assessment for the Proposed
Food Use on Field Corn,'' at page 23 in docket ID number EPA-HQ-OPP-
2007-0871.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flumioxazin, EPA considered exposure under the petitioned-
for tolerances as well as all existing flumioxazin tolerances in (40
CFR 180.568). EPA assessed dietary exposures from flumioxazin in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effect was
identified for the general population. However, EPA identified
potential acute effects, e.g., cardiovascular effects in offspring, for
the population subgroup, females 13

to 49 years. In estimating acute dietary exposure, EPA used food
consumption information from the U.S. Department of Agriculture (USDA)
1994-1996 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA assumed all foods for which
there are tolerances (current and proposed) were treated (100% crop
treated assumption) and contain tolerance-level residues. Percent crop
treated (PCT) and/or anticipated residues were not used in the acute
risk assessment.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
CSFII. As to residue levels in food, EPA assumed all foods for which
there are tolerances (current and proposed) were treated (100 PCT
assumption) and contain tolerance-level residues. Percent crop treated
(PCT) and/or anticipated residues were not used in the risk assessment.
    iii. Cancer. The Agency has determined that flumioxazin is ``not
likely to be a human carcinogen'' based on the lack of carcinogenicity
in a 2-rat study, an 18 month mouse study, and a battery of mutagenic
studies. Therefore, a quantitative exposure assessment to evaluate
cancer risk is unnecessary.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flumioxazin and its degradates, 482-HA and APF, in
drinking water. These simulation models take into account data on the
physical, chemical, and fate/transport characteristics of flumioxazin
and its degradates. Further information regarding EPA drinking water
models used in pesticide exposure assessment can be found at http://
www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of flumioxazin for
acute exposures are estimated to be 34 parts per billion (ppb) for
surface water and 48 ppb for ground water.
    The EDWCs for chronic exposures for non-cancer assessments are
estimated to be 18 ppb for surface water and 48 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 48 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 48 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Flumioxazin is not registered for any specific use patterns that
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found flumioxazin to share a common mechanism of
toxicity with any other substances, and flumioxazin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
flumioxazin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The pre-natal and post-natal
toxicity database for flumioxazin includes the rat and rabbit
developmental toxicity studies and the 2-generation reproduction
toxicity study in rats. There is evidence of quantitative
susceptibility following oral and dermal exposures to rats. Following
in utero exposures, developmental effects (cardiovascular anomalies)
were seen in the absence of maternal toxicity. There is no evidence
(quantitative or qualitative) of susceptibility following in utero oral
exposure in rabbits. No developmental toxicity was seen at the highest
dose tested (3x the Limit-Dose). There is quantitative evidence of
susceptibility in the multi-generation reproduction study where effects
in offspring were seen at doses lower than those which induced effects
in parental animals.
    Although increased pre-natal and post-natal quantitative
susceptibility was seen in rats, the Agency concluded that there is a
low concern and no residual uncertainties for pre-natal and/or post-
natal toxicity effects of flumioxazin because:
    i. Developmental toxicity (including cardiovascular abnormalities)
NOAELs and LOAELs from pre-natal exposure are well characterized after
oral and dermal exposure,
    ii. The off-spring toxicity NOAEL and LOAEL from post-natal
exposure are well characterized,
    iii. The dose selected for risk assessment is protective of all
potential effects.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for flumioxazin is complete.
    ii. There is no indication that flumioxazin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. Although there is quantitative evidence of increased
susceptibility in the pre-natal developmental studies and post-natal
multi-generation study in rats, EPA did not identify any residual
uncertainties after establishing toxicity endpoints and traditional UFs
to be used in the risk assessment of flumioxazin. The degree of concern
for pre-natal and/or post-natal toxicity is low.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues for all commodities. EPA made
conservative (protective) assumptions in the ground water and surface
water modeling used to assess exposure to flumioxazin in drinking
water. EPA used similarly conservative assumptions to assess post
application exposure of children as well

as incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by flumioxazin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to flumioxazin will occupy 8% of the aPAD for (females 13 to 49) the
population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flumioxazin from food and water will utilize 19% of the cPAD for
(Infants less than 1 year old) the population group receiving the
greatest exposure. There are no residential uses for flumioxazin.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Flumioxazin is not registered for any use patterns that would
result in residential exposure. Therefore, the short-term aggregate
risk is the sum of the risk from exposure to flumioxazin through food
and water and will not be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Flumioxazin is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to flumioxazin through food and water, which has already been
addressed, and will not be greater than the chronic aggregate risk.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to flumioxazin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/nitrogen-
phosphorus detection) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    There are no established or proposed Canadian, Mexican or Codex
maximum residue levels (MRLs) for residues of flumioxazin in plant
commodities subject to this action.

V. Conclusion

    Therefore, tolerances are established for residues of flumioxazin,
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or on corn, field
grain; corn, field forage; and corn, field stover at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: June 26, 2008
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.568 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec.  180.568  Flumioxazin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Corn, field, forage..................................               0.02
Corn, field, grain...................................               0.02
Corn, field, stover..................................               0.02
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-15316 Filed 7-8-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Pages 57942-57944]
[FR Doc No: 2014-22983]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1413]

Patient-Focused Drug Development Public Meeting and Scientific
Workshop on Female Sexual Dysfunction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting and workshop; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting and scientific workshop, both of which will provide an
opportunity for public comment on the topic of Female Sexual Interest/
Arousal Disorder (FSIAD), the most common form of female sexual
dysfunction. FSIAD is a diagnosis that combines two previously distinct
disorders--hypoactive sexual desire disorder (HSDD) and female sexual
arousal disorder (FSAD). The public meeting will take place on October
27, 2014, and is part of FDA's Patient-Focused Drug Development
performance commitments made as part of the fifth authorization of the
Prescription Drug User Fee Act (PDUFA V). At this meeting, FDA will
obtain patients' perspectives on the impact that FSIAD (or a prior
diagnosis of HSDD or FSAD) has on their daily lives, as well as their
perspectives on the available therapies for these conditions. The
scientific workshop will take place on October 28, 2014, and will
provide an opportunity for FDA to seek input from experts on scientific
issues important to the clinical development of drug products intended
to treat FSIAD.

DATES: The meeting will be held on October 27, 2014, from 12 p.m. to 5
p.m. and the workshop will be held on October 28, 2014, from 8 a.m. to
5 p.m. Registration to attend either the meeting or the workshop must
be received by October 17, 2014. See the SUPPLEMENTARY INFORMATION
section for information on how to register for either the meeting or
the workshop. Submit electronic or written comments by December 29,
2014.

ADDRESSES: The meeting and workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Sections
B/C of the Great Room (rm. 1503), Silver Spring, MD 20993. Entrance for
the public meeting and workshop participants (non-FDA employees) is
through Building 1 where routine security check procedures will be
performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit electronic comments to www.regulations.gov. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All
comments should be identified with the

docket number found in brackets in the heading of this document. Please
indicate whether the comments are relevant to the October 27 meeting or
the October 28 workshop. FDA will post the agenda approximately 5 days
before the meeting at http://www.fda.gov/Drugs/NewsEvents/ucm401167.htm.

FOR FURTHER INFORMATION CONTACT:
    For questions regarding the October 27 Patient-Focused Drug
Development meeting: Pujita Vaidya, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 1144, Silver Spring, MD 20993,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
<EMAIL_ADDRESS>    For questions regarding the October 28 scientific workshop:
Charlene Williamson, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5332,
Silver Spring, MD 20993,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected female sexual dysfunction as the focus of a
meeting under Patient-Focused Drug Development initiative that involves
obtaining a better understanding of patients' perspectives on the
severity of the disease and the available therapies for the condition.
This Patient-Focused Drug Development meeting is being conducted to
fulfill FDA's performance commitments made as part of the authorization
of PDUFA V under Title I of the Food and Drug Safety and Innovation Act
(Pub. L. 112-144). The full set of performance commitments is available
on the FDA Web site at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    FDA has committed to obtain the patient perspective in 20 disease
areas during the course of PDUFA V. For each disease area, the Agency
will conduct a public meeting to discuss the disease and its impact on
patients' daily lives, the types of treatment benefit that matter most
to patients, and patients' perspectives on the adequacy of the
available therapies. These meetings will include participation of FDA
review divisions, the relevant patient community, and other interested
stakeholders.
    On April 11, 2013, FDA published a notice in the Federal Register
(78 FR 21613) announcing the disease areas for meetings in fiscal years
(FYs) 2013 through 2015, the first 3 years of the 5-year PDUFA V time
frame. To develop the list of disease areas, the Agency used several
criteria that were outlined in the April 11 notice. The Agency obtained
public comment on these criteria and potential disease areas through a
notice for public comment published in the Federal Register on
September 24, 2012 (77 FR 58849), and through a public meeting held on
October 25, 2012. In selecting the disease areas, FDA carefully
considered the public comments received and the perspectives of its
review divisions. By the end of FY 2015, FDA will initiate another
public process to determine the disease areas for FYs 2016 through
2017. More information, including the list of disease areas and a
general schedule of meetings, is posted at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.

II. Public Meeting and Workshop Information

A. Purpose and Scope of the Meeting and Workshop

    On October 27, 2014, as part of Patient-Focused Drug Development,
FDA will obtain patient and patient stakeholder input on symptoms of
female sexual dysfunction that matter most to patients and on current
approaches to treating female sexual dysfunction. The most common form
of female sexual dysfunction, FSIAD, refers to absent or reduced sexual
interest/arousal that causes clinically significant distress and is not
caused by another condition (such as another medical disorder or the
effects of medications). There are no FDA-approved drug therapies to
treat FSIAD. FDA is committed to working with all stakeholders to
foster the development of safe and effective therapies for affected
women.
    The questions that will be asked of patients and patient
stakeholders at the meeting are listed in this section and organized by
topic. For each topic, a brief patient panel discussion will begin the
dialogue, followed by a facilitated discussion inviting comments from
other patients and patient stakeholders. In addition to input received
through this public meeting, FDA is interested in receiving patient
input addressing these questions through written comments that can be
submitted to the public docket (see ADDRESSES).
1. Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
     Have you ever received a diagnosis from a healthcare
provider of sexual interest/arousal disorder, hypoactive sexual desire
disorder, or sexual arousal disorder?
     How was the diagnosis made? For example, what type of
healthcare provider made the diagnosis? Were any tests or
questionnaires used to help make the diagnosis?
     Of all the symptoms that you experience because of your
condition, which 1 to 3 symptoms have the most significant impact on
your life? Please describe each symptom in detail, including how this
symptom specifically affects your sexual experiences.
     Do your symptoms wax and wane over time? For example, do
you have better days and worse days? If your symptoms wax and wane,
please answer the following questions:
     Which symptoms vary the most, and in what ways?
     How do your symptoms and their negative impacts on your
sexual experiences compare between your ``best days'' and your ``worst
days''?
     Do the changes in your symptoms typically happen over a
period of minutes, hours, days, weeks, or months?
     If you were asked today to accurately rate how good or how
bad your symptoms have been over time, would you be able to accurately
remember how your symptoms felt one day ago? Over the past 3 days? Over
the past week? Over the past 2 weeks? Over the past 3 weeks? Over the
past month?
     Is there anything else that you believe makes your
symptoms better? Is there anything that you believe makes your symptoms
worse? For example, menstruation, stress, etc.
     Overall, have you experienced your condition and its
symptoms getting progressively worse, improving, or remaining stable
over the past few years?
     What worries you most about your condition?
2. Topic 2: Patient perspectives on Current Approaches To Treat FSIAD
     What are you currently doing to help treat your condition
or its symptoms? (Examples may include prescription medicines, over-
the-counter products, physical or other therapies, support groups, and
lifestyle changes.)
     How well do your current treatments specifically treat the
most significant symptoms of your condition?
     How well have your treatments improved your sexual
experience?
     How has your treatment regimen changed over time, and why?
     Are there any downsides to the treatments you have used?
(Examples of downsides may include bothersome

side effects, difficulty identifying appropriate healthcare providers,
etc.)
     What specific things would you look for in an ideal
treatment for your condition? For example, which symptom would you most
like a treatment to target and what would you consider to be a
meaningful improvement in this symptom?
    The scientific workshop on October 28, 2014 will include a
discussion of scientific challenges related to:
     Diagnosis of the condition for clinical trials and in
clinical practice and
     ensuring valid patient-reported outcome measures for the
key efficacy endpoints used in clinical trials.

B. Meeting and Workshop Attendance and Participation

    If you wish to attend the Patient-Focused Drug Development meeting
or scientific workshop, visit http://fsdpatientfocused.eventbrite.com.
Please register for either the meeting or workshop by October 17, 2014.
If you are unable to attend the meeting or workshop in person, you can
register to view a live Webcast. You will be asked to indicate in your
registration whether you plan to attend in person or via the Webcast.
    Seating will be limited, so early registration is recommended.
Registration is free and will be on a first-come, first-served basis.
However, FDA may limit the number of participants from each
organization based on space limitations. Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the meetings will be based on space availability. If you need
special accommodations because of disability, please contact Pujita
Vaidya or Charlene Williamson (see FOR FURTHER INFORMATION CONTACT) at
least 7 days before the meeting.
    Patients who are interested in presenting comments as part of the
initial panel discussions during the October 27 meeting must indicate
in their registration which topic(s) they wish to address. These
patients also must send a brief summary of responses to the topic
questions by October 3, 2014, to<EMAIL_ADDRESS>Panelists
will be notified of their selection approximately 7 days before the
public meeting. We will try to accommodate all patients and patient
stakeholders who wish to speak, either through the panel discussion or
audience participation; however, the duration of comments may be
limited by time constraints.
    FDA will hold an open public comment period during the October 27
meeting and the October 28 workshop to give the public an opportunity
to comment. Registration for open public comment will occur at the
registration desk on the day of the meeting and workshop on a first-
come, first-serve basis.

III. Comments

    Regardless of attendance at the Patient-Focused Drug Development
meeting, you can submit electronic or written comments, including
responses to the questions pertaining to Topics 1 and 2, to the public
docket (see ADDRESSES) by December 29, 2014. Please indicate whether
the comments are relevant to the October 27 meeting or the October 28
workshop. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday, and will
be posted to the docket at http://www.regulations.gov.

IV. Transcripts

    As soon as a transcript is available, FDA will post it at http://www.fda.gov/Drugs/NewsEvents/ucm401167.htm.

    Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22983 Filed 9-25-14; 8:45 am]
BILLING CODE 4164-01-P


June 5, 2019  -  WA HHC Proposal to Withdraw  Tribal Informational Call #2

Tribal Attendees:  Makah Snoqualmie Nez Perce Swinomish Umatilla Puyallup  Lower Elwha Klallam Tribe Stillaguamish NWIFC

EPA Attendees: Dan Opalski, Wenona Wilson, Hanh Shaw, Matt Szelag, Andy Byrne, Erica Fleisig

Questions and Comments from Tribal Attendees

    Reiterate the objections voiced yesterday by tribal leaders regarding relaxing of standards and lack of tribal consultations; Reserve rights to make those claims in the future; During the April call, we expressed opposition to the repeal of the WQS, EPA moving forward on May 10 is unacceptable to the tribes; The existing rule is science-based and legally defensible; Lack of tribal consultation is inconsistent with EPA's consultation policy and letter from the RA on February 8; The tribes expect nothing less than EPA consulting on a government-to-government basis prior to any decisions; Q: why did EPA proceeded with May 10 decision without consultation?

    EPA felt that its previous consultation where tribes shared the protectiveness of the criteria to its resources, tribal treaty rights, etc., was adequate for the EPA to reverse the final disapproval on May 10?

    You said the earlier consultations provided adequate insight to EPA's May 10 decision. During all those consultations, do you recall any tribal support for the state's standards or was it all support for the federal rulemaking?

    The point is there was universal opposition to the WQS you have now approved. The EPA decision-makers completely ignored and overruled the tribal input entirely. While relying on the earlier consultations, the perspectives of the tribes were not heeded at all.

    This phone call is not a consultation. None of these calls have been consultations yet decisions have been made. As a tribal leader, I feel the decision has been made and EPA is just going through the process. This is not consultation. When we worked on this earlier, it was a thoughtful slow process of 20+ years; now we are fast-pacing it. Why July 19 as a deadline? Will EPA provide a draft of the proposed rule? What will be in the administrative record? I want to have consultations with the decision maker and I wonder who that is?

    With regard to the administrative record, assume it would include the previous record in its entirety from the 2016 decision? Expectation is the previous record  -  everything related to that is relevant to this administrative record and should remain in place.

    You are hearing lots of frustration; seems like overnight, the previous decision was reversed.

    Regarding the question of who is the decision authority, you indicated it is the Administrator. That is who the tribes want to consult with. The letters from the tribes will make that request clear.

    Specifically to Dan, thank you for your hard work, I know you are not the decision-maker but a messenger; I know how hard it is for you. I can use your help with making sure the government respects our treaties.

    We appreciate the position you and other folks are in, so thank you.

    Reiterate request that documentation of the issues you are transmitting to HQ be shared with the tribes; want to see how tribal perspectives are translated.


[Federal Register: January 18, 2011 (Volume 76, Number 11)]
[Notices]
[Page 2895-2897]
[DOCID:fr18ja11-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

January 5, 2011.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER99-4124-028.
    Applicants: Arizona Public Service Company.
    Description: Notice of Non-material Change in Status of Arizona
Public Service Company.
    Filed Date: 01/05/2011.
    Accession Number: 20110105-5047.
    Comment Date: 5 p.m. Eastern Time on Wednesday, January 26, 2011.

    Docket Numbers: ER07-553-001.
    Applicants: Emera Energy Services Subsidiary No. 1 LLC.
    Description: Tariff Numbering Sheet for Emera Energy Services
Subsidiary No. 1, LLC, Inc, FERC Electric Tariff, Original Volume No.
1, inception to date.
    Filed Date: 01/04/2011.
    Accession Number: 20090110-1420.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 25, 2011.

    Docket Numbers: ER10-2578-002.
    Applicants: Fox Energy Company, LLC.
    Description: Fox Energy Company, LLC submits tariff filing per 35:
Compliance Fox Energy Company to be effective 9/10/2010.
    Filed Date: 01/04/2011.
    Accession Number: 20110104-5084.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 25, 2011.

    Docket Numbers: ER10-2665-002.
    Applicants: UNS Electric, Inc.
    Description: UNS Electric, Inc. submits tariff filing per 35.17(a):

Request for Withdrawal of OATT Filing in Docket No. ER10-2665-002 to be
effective N/A.
    Filed Date: 01/04/2011.
    Accession Number: 20110104-5031.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 25, 2011.

    Docket Numbers: ER11-2048-001.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. submits
tariff filing per: Supplemental Filing to Correct Image Rendering Issue
to be effective 4/1/2011.
    Filed Date: 01/04/2011.
    Accession Number: 20110104-5087.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 25, 2011.

    Docket Numbers: ER11-2332-001.
    Applicants: UBS AG.
    Description: UBS AG submits tariff filing per 35: Supplement to
Request for Category 1 Status to be effective 12/10/2010.
    Filed Date: 01/04/2011.
    Accession Number: 20110104-5101.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 25, 2011.

    Docket Numbers: ER11-2598-001; ER11-2607-001; ER11-2612-001.
    Applicants: Sempra Energy Trading LLC, MxEnergy Electric Inc.,
Gateway Energy Services Corporation.
    Description: Notice of Category 1 Seller Status of Sempra Energy
Trading LLC, MXenergy Electric Inc., and Gateway Energy Services
Corporation.
    Filed Date: 01/04/2011.
    Accession Number: 20110104-5135.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 25, 2011.

    Docket Numbers: ER11-2619-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits tariff filing per
35.13(a)(2)(iii: Ministerial Filing to Reflect Tariff Language Accepted
in ER10-45-001 to be effective 7/26/2010.
    Filed Date: 01/04/2011.
    Accession Number: 20110104-5078.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 25, 2011.

    Docket Numbers: ER11-2620-000.
    Applicants: Community Wind North, LLC.
    Description: Community Wind North, LLC submits tariff filing per
35.1: Filing of Jurisdictional Agreement to be effective 1/5/2011.
    Filed Date: 01/04/2011.
    Accession Number: 20110104-5079.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 25, 2011.

    Docket Numbers: ER11-2621-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits tariff filing
per 35.13(a)(2)(iii: PWRPA Interconnection and WDT Service Agreements
to be effective 1/5/2011.
    Filed Date: 01/04/2011.
    Accession Number: 20110104-5099.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 25, 2011.

    Docket Numbers: ER11-2622-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, L.L.C. submits tariff filing per
35.13(a)(2)(iii: 2010 RTEP December Board Filing to be effective 4/4/
2011.
    Filed Date: 01/04/2011.
    Accession Number: 20110104-5103.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 25, 2011.

    Docket Numbers: ER11-2623-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc. Resource Termination Filing
(Energy Curtailment Specialists).
    Filed Date: 01/04/2011.
    Accession Number: 20110104-5133.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 25, 2011.

    Docket Numbers: ER11-2624-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Notices of Cancellation of Duke Energy Carolinas, LLC.
    Filed Date: 01/05/2011.
    Accession Number: 20110105-5018.
    Comment Date: 5 p.m. Eastern Time on Wednesday, January 26, 2011.

    Docket Numbers: ER11-2626-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc. submits tariff filing per
35.13(a)(2)(iii: Revisions to Correct Tariff Records to be effective 1/
1/2011.
    Filed Date: 01/05/2011.
    Accession Number: 20110105-5036.
    Comment Date: 5 p.m. Eastern Time on Wednesday, January 26, 2011.

    Docket Numbers: ER11-2627-000.
    Applicants: Blue Spruce Energy Center, LLC.
    Description: Blue Spruce Energy Center, LLC submits tariff filing
per 35.15: 20110105--Cancel Tariff ID to be effective 12/6/2010.
    Filed Date: 01/05/2011.
    Accession Number: 20110105-5037.
    Comment Date: 5 p.m. Eastern Time on Wednesday, January 26, 2011.

    Docket Numbers: ER11-2628-000.
    Applicants: Arizona Public Service Company.
    Description: Arizona Public Service Company submits tariff filing
per 35: Revise APS's Market-Based Rate Tariff, FERC Electric Tariff,
Volume No. 3 to be effective 12/17/2010.
    Filed Date: 01/05/2011.
    Accession Number: 20110105-5038.
    Comment Date: 5 p.m. Eastern Time on Wednesday, January 26, 2011.

    Docket Numbers: ER11-2629-000.
    Applicants: Rocky Mountain Energy Center, LLC.
    Description: Rocky Mountain Energy Center, LLC submits tariff
filing per 35.15: 20110105--Cancel Tariff ID to be effective 12/6/2010.
    Filed Date: 01/05/2011.
    Accession Number: 20110105-5041.
    Comment Date: 5 p.m. Eastern Time on Wednesday, January 26, 2011.

    Docket Numbers: ER11-2630-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, L.L.C. submits tariff filing per
35.13(a)(2)(iii: Revisions to the Tariff and Operating Agreement
regarding a Late Payment Charge to be effective 4[sol]1[sol]2011.
    Filed Date: 01/05/2011.
    Accession Number: 20110105-5049.
    Comment Date: 5 p.m. Eastern Time on Wednesday, January 26, 2011.

    Docket Numbers: ER11-2631-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. submits
tariff filing per 35.13(a)(2)(iii: SGIA Among NYISO, NYSEG, and AES ES
Westover to be effective 12/9/2010.
    Filed Date: 01/05/2011.
    Accession Number: 20110105-5092.
    Comment Date: 5 p.m. Eastern Time on Wednesday, January 26, 2011.

    Docket Numbers: ER11-2632-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits tariff filing per
35.13(a)(2)(iii: 2060 CPV Keenan II Renewable Energy, LLC GIA to be
effective 12/6/2010.
    Filed Date: 01/05/2011.
    Accession Number: 20110105-5096.
    Comment Date: 5 p.m. Eastern Time on Wednesday, January 26, 2011.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or

protest must serve a copy of that document on the Applicant. In
reference to filings initiating a new proceeding, interventions or
protests submitted on or before the comment deadline need not be served
on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-900 Filed 1-14-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 233 (Friday, December 4, 2015)]
[Rules and Regulations]
[Page 75811]
[FR Doc No: 2015-30637]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-0999]

Drawbridge Operation Regulation; Upper Mississippi River,
Dubuque, IA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Illinois Central Railroad
Drawbridge across the Mississippi River, mile 579.9, at Dubuque, Iowa.
The deviation is necessary to allow the bridge owner time to perform
preventive maintenance that is essential to the safe operation of the
drawbridge. Maintenance is scheduled in the winter when there is less
impact on navigation, instead of scheduling work in the summer when
river traffic increases. This deviation allows the bridge to open on
signal if at least 24-hours advance notice is given. It further allows
the bridge to remain closed for up to 120 hours in duration
occasionally to replace larger components as long as 72-hours notice is
given to the USCG District Eight Western Rivers Bridge Branch.

DATES: This deviation is effective from 5 p.m., December 14, 2015 until
9 a.m., February 29, 2016.

ADDRESSES: The docket for this deviation, (USCG-2015-0999) is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Eric A. Washburn, Bridge
Administrator, Western Rivers, Coast Guard; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Chicago, Central & Pacific Railroad
requested a temporary deviation for the Illinois Central Railroad
Drawbridge, across the Upper Mississippi River, mile 579.9, at Dubuque,
Iowa to open on signal if at least 24-hours advance notice is given for
77 days from 5 p.m., December 14, 2015 until 9 a.m., February 29, 2016
for scheduled maintenance on the bridge. The deviation further allows
the bridge to remain closed for up to 120 hours in duration
occasionally to replace larger components as long as 72-hours notice is
given to the USCG District Eight Western Rivers Bridge Branch.
    The Illinois Central Railroad Drawbridge currently operates in
accordance with 33 CFR 117.5, which states the general requirement that
the drawbridge shall open on signal.
    There are no alternate routes for vessels transiting this section
of the Upper Mississippi River. The bridge cannot open in case of
emergency.
    Winter conditions on the Upper Mississippi River coupled with the
closure of Army Corps of Engineer's Lock No. 13 (Mile 522.5 UMR) and
Lock No. 21 (Mile 324.9 UMR) from 7 a.m. January 4, 2016 until 12 p.m.,
March 4, 2016 will preclude any significant navigation demands for the
drawspan opening. In addition, Army Corps Lock No. 14 (Mile 493.3 UMR)
and Lock No. 17 (Mile 437.1 UMR) will be closed from 7 a.m. December
14, 2015 until 12 p.m. March 2, 2016.
    The Illinois Central Railroad Drawbridge provides a vertical
clearance of 19.9 feet above normal pool in the closed-to-navigation
position. Navigation on the waterway consists primarily of commercial
tows and recreational watercraft and will not be significantly
impacted. The drawbridge will open if at least 24-hours advance notice
is given and will close for up to 120 hours provided 72-hours advance
notice is given to the USCG District Eight Western Rivers Bridge
Branch. This temporary deviation has been coordinated with waterway
users. No objections were received.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: November 27, 2015.
Eric A. Washburn,
Bridge Administrator, Western Rivers.
[FR Doc. 2015-30637 Filed 12-3-15; 8:45 am]
 BILLING CODE 9110-04-P