[Federal Register: September 23, 2010 (Volume 75, Number 184)]
[Notices]
[Page 57945-57947]
[DOCID:fr23se10-49]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0730; FRL-8844-5]

Atonik and Verbenone, Registration Review Proposed Decisions;
Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's proposed
registration review decisions for the pesticides listed in the table in
Unit II.A. and opens a public comment period on the proposed decisions.
Registration review is EPA's periodic review of pesticide registrations
to ensure that each pesticide continues to satisfy the statutory
standard for registration, that is, that the pesticide can perform its
intended function without unreasonable adverse effects on human health
or the environment. Through this program, EPA is ensuring that each
pesticide's registration is based on current scientific and other
knowledge, including its effects on human health and the environment.

DATES: Comments must be received on or before November 22, 2010.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number for the specific pesticide of interest
provided in the table in Unit II.A. 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 the docket identification
(ID) number for the specific pesticide of interest provided in the
table in Unit II.A. 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: For pesticide specific information,
contact: The Regulatory Action Leader for the pesticide of interest
identified in the table in Unit II.A.
    For general information on the registration review program,
contact: Kevin Costello, Pesticide Re-evaluation Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-5026; 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, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the chemical review manager listed under FOR FURTHER
INFORMATION CONTACT.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one

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

II. Background

A. What Action is the Agency Taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability
of EPA's proposed registration review decisions for the pesticides
shown in the following table, and opens a 60-day public comment period
on the proposed decisions.
    Atonik, plant growth regulators (PGRs) consist of three naturally-
occurring nitrophenolates: Sodium 5-nitroguaiacolate, sodium o-
nitrophenolate, and sodium p-nitrophenolate. The PGRs in atonik are
simple synthetic nitrophenols solubilized in sodium hydroxide. Atonik
is intended for use on cotton, rice, and soybean plants.
    The verbenone & 4-allyl anisole registration review case contains 2
active seperate ingredients, verbenone and 4-allyl anisole. Verbenone
is a terpene that acts as an anti-aggregation pheromone in Dendroctonus
and Lps species. Verbenone is used on pine trees in forests to control
bark beetles, such as the southern pine beetle Dendroctonus frontalis.
4-allyl anisole is an alkenylbenzene compound that is produced by
conifers during bark beetle Dendroctonus sp. infestations. 4-allyl
anisole acts as an anti-aggregation agent by signaling the beetles that
the tree has already been colonized and therefore is an unsuitable
host. There is one manufacturing use product that is registered
containing the active ingredient and there are no registered end use
products that are being produced, sold, distributed, or used.

              Registration Review Proposed Final Decisions
------------------------------------------------------------------------
                                                       Chemical Review
 Registration Review Case Name    Pesticide Docket    Manager, Telephone
           and Number                 ID Number         Number, E-mail
                                                           Address
------------------------------------------------------------------------
Atonik (6067)                    EPA-HQ-OPP-2008-08  Driss Benmhend,
                                  32<PHONE_NUMBER>,
                                                     benmhend.driss@epa.
                                                      gov
------------------------------------------------------------------------
Verbenone & 4-Allyl Anisole      EPA-HQ-OPP-2009-05  Leonard Cole, (703)
 (6031)                           11                  305-5412,
<EMAIL_ADDRESS>                                                      v
------------------------------------------------------------------------

    The registration review docket for a pesticide includes earlier
documents related to the registration review of the case. For example,
the review opened with the posting of a Summary Document, containing a
Preliminary Work Plan, for public comment. A Final Work Plan was posted
to the docket following public comment on the initial docket. The
documents in the initial dockets described the Agency's rationales for
not conducting additional risk assessments for the registration review
of the pesticides included in the table in Unit II.A. These proposed
registration review decisions continue to be supported by those
rationales included in documents in the initial dockets.
    Following public comment, the Agency will issue final registration
review decisions for products containing the pesticides listed in the
table in Unit II.A.
    The registration review program is being conducted under
congressionally mandated time frames, and EPA recognizes the need both
to make timely decisions and to involve the public. Section 3(g) of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as
amended, required EPA to establish by regulation procedures for
reviewing pesticide registrations, originally with a goal of reviewing
each pesticide's registration every 15 years to ensure that a pesticide
continues to meet the FIFRA standard for registration. The Agency's
final rule to implement this program was issued in August 2006 and
became effective in October 2006, and appears at 40 CFR part 155,
subpart C. The Pesticide Registration Improvement Act of 2003 (PRIA)
was amended and extended in September 2007. FIFRA, as amended by PRIA
in 2007, requires EPA to complete registration review decisions by
October 1, 2022, for all pesticides registered as of October 1, 2007.
    The registration review final rule at 40 CFR 155.58(a) provides for
a minimum 60-day public comment period on all proposed registration
review decisions. This comment period is intended to provide an
opportunity for public input and a mechanism for initiating any
necessary amendments to the proposed decision. All comments should be
submitted using the methods in ADDRESSES, and must be received by EPA
on or before the closing date. These comments will become part of the
docket for the pesticides included in the table in Unit II.A. Comments
received after the close of the comment period will be marked ``late.''
EPA is not required to consider these late comments.
    The Agency will carefully consider all comments received by the
closing date and will provide a ``Response to Comments Memorandum'' in
the docket. The final registration review decision will explain the
effect that any comments had on the decision and provide the Agency's
response to significant comments.
    Background on the registration review program is provided at:
http://www.epa.gov/oppsrrd1/registration_review. Links to earlier
documents related to the registration review of these pesticides are
provided

at: http://www.epa.gov/oppsrrd1/registration_review/reg_review_
status.htm.

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

    Section 3(g) of FIFRA and 40 CFR part 155, subpart C, provide
authority for this action.

List of Subjects

    Environmental protection, Administrative practice and procedure,
Pesticides and pests.

    Dated: September 16, 2010.
W. Michael McDavit,
Acting Director, Biopesticide and Pollution Prevention Division, Office
of Pesticide Programs.

[FR Doc. 2010-23810 Filed 9-22-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 83, Number 65 (Wednesday, April 4, 2018)]
[Notices]
[Pages 14451-14452]
[FR Doc No: 2018-06800]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. TX18-1-000]

Notice of Filing; AEP Energy Partners, Inc.

    Take notice that on March 28, 2018, pursuant to section 211 of the
Federal Power Act \1\ and part 36 of the Federal Energy Regulatory
Commission (Commission) Rules of Practice and Procedure,\2\ AEP Energy
Partners, Inc., LLC filed an application requesting that the Commission
issue an order directing Sharyland Utlities, L.P., AEP Texas, Inc. and
Electric Transmission of Texas, LLC to provide transmission services
for power flows to, from, and over the Sharyland DC Tie, the Eagle Pass
DC Tie and the Laredo VFT Tie, respectively.
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    \1\ 16 U.S.C. 824j (2012).
    \2\ 18 CFR 36.1 et seq.
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    Any person desiring to intervene or to protest this filing 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). 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant. On or before the comment date, it is
not necessary to serve motions to intervene

or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for review in the Commission's Public
Reference Room in Washington, DC There is an ``eSubscription'' link on
the website that enables subscribers to receive email notification when
a document is added to a subscribed docket(s). For assistance with any
FERC Online service, please email [email protected], or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on April 18, 2018.

    Dated: March 29, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-06800 Filed 4-3-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 18, 2010 (Volume 75, Number 200)]
[Rules and Regulations]
[Page 63712-63713]
[DOCID:fr18oc10-7]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30747; Amdt. No. 3394]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective October 18, 2010. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of October 18, 2010.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169; or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_
federal_regulations/ibr_locations.html.
    Availability--All SIAPs and Takeoff Minimums and ODPs are available
online free of charge. Visit http://www.nfdc.faa.gov to register.
Additionally, individual SIAP and Takeoff Minimums and ODP copies may
be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420), Flight Technologies and Programs Divisions,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125),
Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of
Federal Regulations, Part 97 (14 CFR part 97), by establishing,
amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS.
The complete regulators description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA
Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when
required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs, in addition
to their complex nature and the need for a special format make
publication in the Federal Register expensive and impractical.
Furthermore, airmen do not use the regulatory text of the SIAPs,
Takeoff Minimums or ODPs, but instead refer to their depiction on
charts printed by publishers of aeronautical materials. The advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP, Takeoff Minimums and ODP listed on
FAA forms is unnecessary. This amendment provides the affected CFR
sections and specifies the types of SIAPs and the effective dates of
the, associated Takeoff Minimums and ODPs. This amendment also
identifies the airport and its location, the procedure, and the
amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as contained in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts. The
circumstances which created the need for some SIAP and Takeoff Minimums
and ODP amendments may require making them effective in less than 30
days. For the remaining SIAPS and Takeoff Minimums and ODPS, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPS contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPS and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedures before adopting these SIAPS, Takeoff Minimums and
ODPs are impracticable and contrary to the public interest and, where
applicable, that good cause exists for making some SIAPs effective in
less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule '' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and
(3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC on October 1, 2010.
John M. Allen,
Director, Flight Standards Service.

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me, Title 14, Code
of Federal Regulations, Part 97 (14 CFR part 97) is amended by
establishing, amending, suspending, or revoking Standard Instrument
Approach Procedures and/or Takeoff Minimums and/or Obstacle Departure
Procedures effective at 0902 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 18 NOV 2010

Decatur, AL, Pryor Field Rgnl, ILS OR LOC RWY 18, Orig
Decatur, AL, Pryor Field Rgnl, RNAV (GPS) RWY 18, Amdt 1
Meeker, CO, Meeker, RNAV (GPS) RWY 3, Amdt 2
Middletown, DE, Summit, RNAV (GPS) RWY 17, Amdt 2
Middletown, DE, Summit, RNAV (GPS) RWY 35, Amdt 1
Cross City, FL, Cross City, RNAV (GPS) RWY 31, Amdt 1
Cross City, FL, Cross City, RNAV (GPS)-A, Orig
Cross City, FL, Cross City, RNAV (GPS)-B, Orig
Cross City, FL, Cross City, VOR RWY 31, Amdt 19
Cedar Rapids, IA, The Eastern Iowa, ILS OR LOC RWY 9, Amdt 18
Fort Wayne, IN, Smith Field, Takeoff Minimums and Obstacle DP, Amdt
5
Wichita, KS, Wichita Mid Continent, VOR RWY 14, Amdt 1D
Boston, MA, General Edward Lawrence Logan Intl, Takeoff Minimums and
Obstacle DP, Amdt 13
Salisbury, MD, Salisbury-Ocean City Wicomico Rgnl, ILS OR LOC RWY
32, Amdt 8
Salisbury, MD, Salisbury-Ocean City Wicomico Rgnl, RNAV (GPS) RWY 5,
Amdt 1
Salisbury, MD, Salisbury-Ocean City Wicomico Rgnl, RNAV (GPS) RWY
14, Amdt 1
Salisbury, MD, Salisbury-Ocean City Wicomico Rgnl, RNAV (GPS) RWY
23, Amdt 1
Salisbury, MD, Salisbury-Ocean City Wicomico Rgnl, Takeoff Minimums
and Obstacle DP, Amdt 1
Salisbury, MD, Salisbury-Ocean City Wicomico Rgnl, VOR RWY 23, Amdt
10A
Salisbury, MD, Salisbury-Ocean City Wicomico Rgnl, VOR RWY 32, Amdt
10
Monroe City, MO, Capt. Ben Smith Airfield-Monroe City Airport,
Takeoff Minimums and Obstacle DP, Orig
Cleveland, MS, Cleveland Muni, NDB OR GPS RWY 17, Amdt 5, CANCELLED
Choteau, MT, Choteau, Takeoff Minimums and Obstacle DP, Amdt 1
Teterboro, NJ, Teterboro, RNAV (GPS)-C, Orig
Massena, NY, Massena Intl-Richards Field, RNAV (GPS) RWY 5, Amdt 2
Massena, NY, Massena Intl-Richards Field, RNAV (GPS) RWY 9, Amdt 1A
Massena, NY, Massena Intl-Richards Field, RNAV (GPS) RWY 23, Amdt 1A
Massena, NY, Massena Intl-Richards Field, RNAV (GPS) RWY 27, Amdt 1A
Millbrook, NY, Sky Acres, RNAV (GPS) RWY 17, Amdt 1A
New York, NY, LaGuardia, COPTER ILS OR LOC RWY 13, Orig
New York, NY, LaGuardia, COPTER ILS OR LOC/DME RWY 22, Amdt 2
New York, NY, LaGuardia, ILS OR LOC RWY 13, Amdt 1
New York, NY, LaGuardia, LOC RWY 31, Amdt 3
New York, NY, LaGuardia, VOR RWY 4, Amdt 3
New York, NY, LaGuardia, VOR/DME-H, Amdt 3
New York, NY, LaGuardia, VOR-F, Amdt 3
Findlay, OH, Findlay, RNAV (GPS) RWY 36, Amdt 1A
Findlay, OH, Findlay, VOR RWY 7, Amdt 12A
Findlay, OH, Findlay, VOR RWY 25, Amdt 5A
Findlay, OH, Findlay, VOR RWY 36, Amdt 6B
Fostoria, OH, Fostoria Metropolitan, NDB RWY 27, Amdt 5A
Fostoria, OH, Fostoria Metropolitan, RNAV (GPS) RWY 27, Amdt 1A
Fostoria, OH, Fostoria Metropolitan, VOR-A, Amdt 4A
Ravenna, OH, Portage County, RNAV (GPS) RWY 27, Orig
Ravenna, OH, Portage County, Takeoff Minimums and Obstacle DP, Orig
Ravenna, OH, Portage County, VOR-A, Amdt 6
Ravenna, OH, Portage County, VOR/DME RNAV OR GPS RWY 27, Amdt 2B,
CANCELLED
Roseburg, OR, Roseburg Rgnl, Takeoff Minimums and Obstacle DP, Amdt
6
Mount Pocono, PA, Pocono Mountains Muni, RNAV (GPS) RWY 13, Amdt 2
Mount Pocono, PA, Pocono Mountains Muni, RNAV (GPS) RWY 31, Amdt 1
Mount Pocono, PA, Pocono Mountains Muni, Takeoff Minimums and
Obstacle DP, Amdt 2
Mount Pocono, PA, Pocono Mountains Muni, VOR RWY 13, Amdt 7
North Myrtle Beach, SC, Grand Strand, ILS OR LOC/DME RWY 23, Amdt
11A
Brady, TX, Curtis Field, RNAV (GPS) RWY 17, Amdt 1A
Commerce, TX, Commerce Muni, Takeoff Minimums and Obstacle DP, Amdt
2
Commerce, TX, Commerce Muni, VOR/DME-A, Amdt 3
Lancaster, TX, Lancaster Rgnl, Takeoff Minimums and Obstacle DP,
Amdt 2
Friday Harbor, WA, Friday Harbor, Takeoff Minimums and Obstacle DP,
Amdt 3
Siren, WI, Burnett County, VOR OR GPS RWY 5, Amdt 2B
Solon Springs, WI, Solon Springs Muni, NDB RWY 19, Amdt 2A,
CANCELLED

    On September 15, 2010 (75 FR 178) the FAA published an Amendment
in Docket No. 30743, Amdt 3390 to Part 97 of the Federal Aviation
Regulations under section 97.23 and 97.33. The following entries,
effective November 18, 2010, is hereby rescinded:

Fort Lauderdale, FL, Fort Lauderdale/Hollywood Intl, VOR RWY 27R,
Amdt 12, CANCELLED

[FR Doc. 2010-25842 Filed 10-15-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: February 18, 2010 (Volume 75, Number 32)]
[Notices]
[Page 7272-7274]
[DOCID:fr18fe10-34]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0512]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Antimicrobial Animal
Drug Distribution Reports Under Section 105 of the Animal Drug User Fee
Amendments of 2008

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March
22, 2010.

ADDRESSES:  To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910--NEW and
title ``Antimicrobial Animal Drug Distribution Reports Under Section
105 of the Animal Drug User Fee Amendments of 2008.'' Also include the
FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Antimicrobial Animal Drug Distribution Reports Under Section 105 of the
Animal Drug User Fee Amendments of 2008--(OMB Control Number 0910-
NEW)--Extension

    Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA)
amended section 512 of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360b) to require that the sponsor of each new animal
drug that contains an antimicrobial agent submit an annual report to
FDA on the amount of each antimicrobial active ingredient in the drug
that is sold or distributed for use in food-producing animals,
including information on any distributor-labeled product. The
legislation was enacted to address the problem of antimicrobial
resistance, and to help ensure that FDA has the necessary information
to examine safety concerns related to the use of antibiotics in food-
producing animals (154 Congressional Record H7534).
    Each report must specify: (1) The amount of each antimicrobial
active ingredient by container size, strength, and dosage form; (2)
quantities distributed domestically and quantities exported; and (3) a
listing of the target animals, indications, and production classes that
are specified on the approved label of the product.
    The first report must be submitted not later than March 31, 2010.
The report must cover the period of the preceding calendar year and
include separate information for each month of the calendar year. The
reports required under section 105 of ADUFA are required to be separate
from periodic drug experience reports that are required under Sec.
514.80(b)(4) (21 CFR Sec.  514.80(b)(4) (OMB Control No. 0910-0284).
    In the Federal Register of October 26, 2009 (74FR 55046), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received comments from two
organizations. Both commenters supported the information collection and
stated that the data to be collected would be useful in addressing

the problem of antimicrobial resistance. However, both comments
suggested that more extensive measures are necessary to address this
problem. For example, one of the comments stated that the practical
utility of the data would be broadened in conjunction with a larger
federal monitoring effort requiring manufacturers to report uses of
their products in all food animal products, which would involve
collecting data from end users such as veterinarians and animal owners.
The other comment stated that the information collection would not be
sufficient to show how much of each class of antimicrobial is sold for
use in different types of food animals, and recommended that FDA
collect distribution data on medicated feeds for this purpose because
feeds are specific to animal species and class. The comment also
recommended that FDA require all data to be submitted through a Web-
based application directly into a form created by FDA, and that FDA
create a publically accessible database that allows searches by drug
class, dose form, and marketing status. FDA has considered the
comments, but at this time we have decided to only require the
submission of information that is expressly required to be submitted by
section 512(l)(3) of the act. We are pursuing notice and comment
rulemaking to codify these requirements, during which time we will
assess any additional data requirements.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 No. of         Annual Frequency       Total Annual        Hours per
       FD&C Act  Section 512(l)(3)            Respondents         per Response          Responses           Response       Total  Hours    Capital  Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Reports for Sponsors with Active                   29                   6.7                194                 80          15,520        $107,880
 Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Reports for Sponsors with Inactive                 23                   4.0                 92                  1              92  ..............
 Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                15,612        $107,880
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
   FD&C Act
    Section           No. of        Annual Frequency of     Total Annual    Hours per  Record     Total Hours
   512(l)(3)       Respondents         Recordkeeping          Records
----------------------------------------------------------------------------------------------------------------
All Applicants                 34                     1                 34                  2                 68
----------------------------------------------------------------------------------------------------------------
Total                                                                                68
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The reporting burden estimates, including the total number of
annual responses, are based on the number of sponsors and approved
applications for antimicrobial drug products in food-producing animals.
The annual frequency of responses was calculated as the total annual
responses divided by the number of respondents.
    The agency arrived at the estimates for reporting as follows: There
are 34 sponsors with approved applications for antimicrobial drugs for
food-producing animals. There are 29 animal drug manufacturers with 194
approved applications for antimicrobial drugs for food-producing
animals for which the drugs are being actively marketed (active
applications). Additionally, there are 93 approved applications for
antimicrobial drugs for food-producing animals for which the drugs are
not being marketed (inactive applications), owned by 23 animal drug
manufacturers.
    Regarding the reporting burden associated with the collection of
information, FDA believes that the large majority of the burden will be
incurred by industry in the first year in which reporting is required
to design a report that meets the requirements of section 512(l)(3) of
the act. The agency has estimated this burden at 80 hours per applicant
with active applications. The agency has factored into this estimate
the time it will take industry to identify and locate the necessary
information within existing records, and to develop a report that
complies with section 512(l)(3) of the act. Once this has been
accomplished, FDA believes that the process for producing reports in
subsequent years will essentially be automated, and that it will take
approximately 3 hours to run a report that satisfies the act's
requirements. For sponsors of approved applications that are inactive
(i.e., the approved drug is not being marketed), the sponsor would only
have to submit a report stating that the drug is not being marketed,
which FDA estimates will take approximately 1 hour.
    FDA has developed a form to report the information required by
section 512(l)(3) of the act. FDA plans to make the form available to
animal drug manufacturers through FDA's Web site, however, use of the
form would be entirely voluntary. The form contains various fields for
information, including the drug manufacturer's name, NADA number,
active ingredient name, National Drug Code number, container size,
potency, and the number of units sold by month.
    The animal drug manufacturers can meet the statutory requirements
by submitting their information in paper format using either the FDA-
provided form or one of their own design or by designing their own
electronic form whose results could be submitted to the agency on a
compact disc or on paper. The cost to animal drug sponsors for
gathering the necessary information for report design and preparation
or for completing FDA's form in the first year of reporting is $107,880
(29 active sponsors x 80 hours x $46.50 per hour = $107,880). This is a
one-time cost for a computer or mathematic employees to design and
prepare a report that satisfies

the statutory requirements of section 512(l)(3) of the act.\1\ For
subsequent years, the preparation of the report should take
approximately 3 hours. Thus, the total cost in subsequent years would
be $139.50.
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    \1\ BLS Occupation Employment and Wages, May 2006, by
occupation, for all industries (http://www.bls.gov). Wage ($46.50)
includes mean hourly wage of $33.22 for Standard Occupational
Classification 15-0000, computer and mathematics occupations, all
industries; we add 40 percent to account for benefits.
---------------------------------------------------------------------------

    Regarding the recordkeeping burden associated with this collection
of information, FDA believes that most of the necessary information for
the annual report required to be submitted under section 512(l)(3) of
the act is already collected and maintained by animal drug
manufacturers under existing requirements.
    Animal drug manufacturers are already required to maintain
distribution records for their drug products to comply with FDA's
current good manufacturing practice regulations under Sec.  211.196 (21
CFR Sec.  211.96) (OMB Control No. 0910-0139), and to comply with
regulations for periodic drug experience reports under Sec.
514.80(b)(4)(i) (OMB Control No. 0910-0284). Therefore, FDA believes
that manufacturers of animal drugs already possess the computers,
software, and additional equipment necessary to collect and maintain
the necessary records and to make reports.
    Section 512(l)(3) of the act differs from Sec.  514.80(b)(4)(i) in
that it requires that records include separate information for each
month of the calendar year. Under Sec.  211.196 (OMB Control No. 0910-
0139), manufacturers currently are required to maintain distribution
records that include the dosage form and date the drug is distributed.
Additionally, FDA believes that manufacturers already keep detailed
records of the dates when antimicrobial drugs are distributed for
marketing and recall purposes from which monthly reports can be
prepared as part of their usual and customary practice. However, FDA
estimates an additional hourly burden required by section 512(l)(3) of
the act as shown in table 2 of this document.

    Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3029 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S