[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Page 42888]
[FR Doc No: 2018-18321]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. ER18-2241-000]

Supplemental Notice That Initial Market-Based Rate Filing
Includes Request for Blanket Section 204 Authorization: Garnet Wind,
LLC

    This is a supplemental notice in the above-referenced proceeding
Garnet Wind, LLC`s application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability. Any person
desiring to intervene or to protest should file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is September 10, 2018.
    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
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic 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<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: August 20, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-18321 Filed 8-23-18; 8:45 am]
BILLING CODE 6717-01-P


From:	"Lee, Amanda I."<EMAIL_ADDRESS> To:	Ross Brennan/DC/USEPA/US@EPA, Cindy Newberg/DC/USEPA/US@EPA

Cc:	Jeremy Arling/DC/USEPA/US@EPA, Staci Gatica/DC/USEPA/US@EPA, JohnB

Chamberlin/DC/USEPA/US@EPA

Date:	11/03/2009 05:09 PM

Subject:	FW: EPA's FRM on importation ban on pre-charged products

From: Kohl, Elizabeth<EMAIL_ADDRESS> Sent: Tuesday, November 03, 2009 4:37 PM

To: Lee, Amanda I.

Subject: FW: EPA's FRM on importation ban on pre-charged products

Good afternoon, Amanda -- DOE has no comment on the attached EPA rule.

Thank you for the review opportunity. -- Betsy

Betsy Kohl

Attorney-Adviser

Office of the General Counsel

U.S. Department of Energy

202-586-7796

From: Lee, Amanda I<EMAIL_ADDRESS> Sent: Wednesday, October 14, 2009 3:32 PM

To: Thompson, John E (OES); Finman, Hodayah H (OES); Buffa, Nicole; Smith,

Russell; MacNeil, John S.; Holman, Keith W.; Bromberg, Kevin L.; Cohen,

Daniel

Cc<EMAIL_ADDRESS><EMAIL_ADDRESS>Kymn,

Christine J.

Subject: EPA's FRM on importation ban on pre-charged products

Hi all,

Please find attached EPA’s final rule on ban on importation of pre-charged

products.  Please submit your comments by COB October 30, 2009.  As usual,

many apologies for a short time frame to review.

Also, please plan on having a conference call on November 4 to discuss

your major concerns.  You’ll have another opportunity to discuss other

and/or follow-up concerns at a later date.

Many thanks!

Amanda


[Federal Register: September 17, 2008 (Volume 73, Number 181)]
[Proposed Rules]
[Page 53809-53814]
[DOCID:fr17se08-44]

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

Federal Emergency Management Agency

44 CFR Part 67

[Docket No. FEMA-B-1004]

Proposed Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule.

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

SUMMARY: Comments are requested on the proposed Base (1 percent annual-
chance) Flood Elevations (BFEs) and proposed BFE modifications for the
communities listed in the table below. The purpose of this notice is to
seek general information and comment regarding the proposed regulatory
flood elevations for the reach described by the downstream and upstream
locations in the table below. The BFEs and modified BFEs are a part of
the floodplain management measures that the community is required
either to adopt or show evidence of having in effect in order to
qualify or remain qualified for participation in the National Flood
Insurance Program (NFIP). In addition, these elevations, once
finalized, will be used by insurance agents, and others to calculate
appropriate flood insurance premium rates for new buildings and the
contents in those buildings.

DATES: Comments are to be submitted on or before December 16, 2008.

ADDRESSES: The corresponding preliminary Flood Insurance Rate Map
(FIRM) for the proposed BFEs for each community are available for
inspection at the community's map repository. The respective addresses
are listed in the table below.
    You may submit comments, identified by Docket No. FEMA-B-1004, to
William R. Blanton, Jr., Chief, Engineering Management Branch,
Mitigation Directorate, Federal Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>, or (e-mail)
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: William R. Blanton, Jr., Chief,
Engineering Management Branch, Mitigation Directorate, Federal
Emergency Management Agency, 500 C Street SW., Washington, DC 20472,
(202) 646-3151 or (e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) proposes to make determinations of BFEs and modified BFEs for
each community listed below, in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR
67.4(a).
    These proposed BFEs and modified BFEs, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own, or pursuant to policies established
by other Federal, State, or regional entities. These proposed
elevations are used to meet the floodplain management requirements of
the NFIP and are also used to calculate the appropriate flood insurance
premium rates for new buildings built after these elevations are made
final, and for the contents in these buildings.
    Comments on any aspect of the Flood Insurance Study and FIRM, other
than the proposed BFEs, will be considered. A letter acknowledging
receipt of any comments will not be sent.
    Administrative Procedure Act Statement. This matter is not a
rulemaking governed by the Administrative Procedure Act (APA), 5 U.S.C.
553. FEMA publishes flood elevation determinations for notice and
comment; however, they are governed by the Flood Disaster Protection
Act of 1973, 42 U.S.C. 4105, and the National Flood Insurance Act of
1968, 42 U.S.C. 4001 et seq., and do not fall under the APA.
    National Environmental Policy Act. This proposed rule is
categorically excluded from the requirements of 44 CFR part 10,
Environmental Consideration. An environmental impact assessment has not
been prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Executive Order 12866, Regulatory Planning and Review. This
proposed rule is not a significant regulatory action under the criteria
of section 3(f) of Executive Order 12866, as amended.
    Executive Order 13132, Federalism. This proposed rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This proposed rule
meets the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.

    Accordingly, 44 CFR part 67 is proposed to be amended as follows:

PART 67--[AMENDED]

    1. The authority citation for part 67 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  67.4  [Amended]

    2. The tables published under the authority of Sec.  67.4 are
proposed to be amended as follows:

----------------------------------------------------------------------------------------------------------------
                                                                  * Elevation in feet
                                                                (NGVD)  + Elevation in
                                                                feet (NAVD)
         Flooding source(s)            Location of referenced     Depth in feet above      Communities affected
                                            elevation**                 ground
                                                              --------------------------
                                                                Effective     Modified
----------------------------------------------------------------------------------------------------------------
                                Orange County, California, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Aliso Creek.........................  At confluence with                +2          +14  City of Laguna Beach,
                                       Pacific Ocean.                                     Unincorporated Areas
                                                                                of Orange County.
                                      Approximately 1.09               +40          +41
                                       miles upstream of
                                       confluence with
                                       Pacific Ocean.
Bluebird Canyon.....................  At confluence with              None          +17  City of Laguna Beach.
                                       Pacific Ocean.
                                      Approximately 0.55 mile         +125         +124
                                       upstream of confluence
                                       with Pacific Ocean.
Canyon Acres Wash...................  Approximately 70 feet           None          +81  City of Laguna Beach.
                                       upstream of confluence
                                       with Laguna Canyon.
                                      Approximately 1,460             None         +185
                                       feet upstream of
                                       Lewellyn Drive.
Laguna Canyon.......................  At confluence with              None          +15  City of Laguna Beach,
                                       Pacific Ocean.                                     Unincorporated Areas
                                                                                of Orange County.
                                      Approximately 0.72 mile         +343         +344
                                       upstream of upstream
                                       most State Highway 73
                                       crossing.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.
                                                    ADDRESSES

City of Laguna Beach

Maps are available for inspection at Laguna Beach City Hall, 505 Forest Avenue, Laguna Beach, CA.

                                      Unincorporated Areas of Orange County

Maps are available for inspection at Orange County Public Works Department, 300 North Flower Street, Santa Ana,
 CA.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
                               Calcasieu Parish, Louisiana, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
                                      Base Flood Elevation           +5-14        +6-17  Unincorporated areas of
                                       changes ranging from 6                             Calcasieu Parish, City
                                       to 17 feet in the form                             of Sulphur, City of
                                       of Coastal.                                        Lake Charles, City of
                                                                                Westlake.
Gulf of Mexico......................  AE/VE zones have been    ...........  ...........  .......................
                                       made.
                                      Intersection with U.S.            +7           +5
                                       Highway 90.
Bayou Choupique.....................  Intersection with                 +9           +6  Unincorporated areas of
                                       Southern Pacific                                   Calcasieu Parish.
                                       Railroad line.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.
                                                    ADDRESSES

City of Westlake

Maps are available for inspection at 1001 Mullberry Street, Westlake, LA 70669.

                                     Unincorporated Areas of Calasieu Parish

Maps are available for inspection at 1015 Pithon Street, Lake Charles, LA 70602.

City of Sulphur

Maps are available for inspection at 500 North Huntington Street, Sulphur, LA 70664.

City of Lake Charles

Maps are available for inspection at 326 Pujo Street, Lake Charles, LA 70602.
----------------------------------------------------------------------------------------------------------------
                            Alleghany County, North Carolina, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Bledsoe Creek.......................  At the confluence with          None        +2752  Alleghany County, Town
                                       Little River.                                      of Sparta.
                                      Approximately 920 feet          None        +2919
                                       upstream of Green
                                       Needles Lane.
Bledsoe Creek Tributary 1...........  At the confluence with          None        +2759  Town of Sparta.
                                       Bledsoe Creek.
                                      Approximately 110 feet          None        +2896
                                       upstream of Cherry
                                       Street.
Brush Creek.........................  At the confluence with          None        +2443  Alleghany County.
                                       Little River.
                                      Approximately 1.6 miles         None        +2522
                                       upstream of Fox Ridge
                                       Road.
Crab Creek..........................  At the confluence with          None        +2337  Alleghany County.
                                       Little River.
                                      Approximately 0.6 mile          None        +2366
                                       upstream of the
                                       confluence with Little
                                       River.
Cranberry Creek.....................  At the Alleghany/Ashe           None        +2739  Alleghany County.
                                       County boundary.
                                      Approximately 850 feet          None        +2743
                                       upstream of the
                                       Alleghany/Ashe County
                                       boundary.
Glade Creek.........................  At the confluence with          None        +2499  Alleghany County.
                                       Little River.
                                      Approximately 1.4 miles         None        +2529
                                       upstream of the
                                       confluence of Glade
                                       Creek Tributary 2.
Glade Creek Tributary 1.............  At the confluence with          None        +2501  Alleghany County.
                                       Glade Creek.
                                      Approximately 0.4 mile          None        +2565
                                       upstream of Fox Den
                                       Lane.
Glade Creek Tributary 2.............  At the confluence with          None        +2509  Alleghany County.
                                       Glade Creek.
                                      Approximately 0.8 mile          None        +2579
                                       upstream of the
                                       confluence with Glade
                                       Creek.
Little River........................  Approximately 1,100             None        +2333  Alleghany County, Town
                                       feet downstream of the                             of Sparta.
                                       confluence of Crab
                                       Creek.
                                      Approximately 1.0 mile          None        +2851
                                       upstream of the
                                       confluence of Little
                                       River Tributary 2.
Little River Tributary 1............  At the confluence with          None        +2587  Alleghany County.
                                       Little River.
                                      Approximately 1,950             None        +2660
                                       feet upstream of the
                                       confluence with Little
                                       River.
Little River Tributary 2............  At the confluence with          None        +2829  Alleghany County, Town
                                       Little River.                                      of Sparta.
                                      Approximately 0.7 mile          None        +2905
                                       upstream of the
                                       confluence with Little
                                       River.
Moccasin Creek......................  At the confluence with          None        +2431  Alleghany County.
                                       Little River.
                                      Approximately 0.6 mile          None        +2480
                                       upstream of the
                                       confluence with Little
                                       River.
New River...........................  Approximately 0.4 mile          None        +2318  Alleghany County.
                                       downstream of the
                                       confluence with New
                                       River Tributary 1.
                                      At the confluence of            None        +2487
                                       South Fork New River
                                       and North Fork New
                                       River.
New River Tributary 1...............  Approximately 200 feet          None        +2319  Alleghany County.
                                       upstream of the
                                       confluence with New
                                       River.
                                      Approximately 0.7 mile          None        +2364
                                       upstream of the
                                       confluence with New
                                       River.
New River Tributary 2...............  At the confluence with          None        +2339  Alleghany County.
                                       New River.
                                      Approximately 1,720             None        +2390
                                       feet upstream of
                                       Riverwood Lane.
Pine Swamp Creek....................  At the confluence with          None        +2803  Alleghany County.
                                       Little River.
                                      Approximately 0.7 mile          None        +2818
                                       upstream of Grandview
                                       Drive (State Road
                                       1172).
South Fork New River................  At the confluence with          None        +2487  Alleghany County.
                                       New River.
                                      Approximately 1.4 miles         None        +2526
                                       upstream of the
                                       confluence of South
                                       Fork New River
                                       Tributary 2.
South Fork New River Tributary 1....  At the confluence with          None        +2509  Alleghany County.
                                       South Fork New River.
                                      Approximately 0.5 mile          None        +2535
                                       upstream of the
                                       confluence with South
                                       Fork New River.
South Fork New River Tributary 2....  At the confluence with          None        +2516  Alleghany County.
                                       South Fork New River.
                                      Approximately 0.7 mile          None        +2572
                                       upstream of the
                                       confluence with South
                                       Fork New River.
Vile Creek..........................  At the confluence with          None        +2674  Alleghany County, Town
                                       Little River.                                      of Sparta.

                                      Approximately 1,660             None        +2759
                                       feet upstream of NC
                                       Highway 18.
Vile Creek Tributary 1..............  At the confluence with          None        +2695  Alleghany County, Town
                                       Vile Creek.                                        of Sparta.
                                      Approximately 0.4 mile          None        +2751
                                       upstream of the
                                       confluence with Vile
                                       Creek.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.
                                                    ADDRESSES

Alleghany County

Maps are available for inspection at Alleghany County Planning Department, County Administration Building, 348
 South Main Street, Sparta, NC.

Town of Sparta

Maps are available for inspection at Sparta Town Hall, 304 South Main Street, Sparta, NC.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
                             Watauga County, North Carolina, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Boone Creek.........................  At the confluence with         +3120        +3122  Town of Boone.
                                       Winkler Creek.
                                      Approximately 350 feet          None        +3311
                                       upstream of West King
                                       Street.
Cobb Creek..........................  At the confluence with          None        +3169  Unincorporated Areas of
                                       Meat Camp Creek.                                   Watauga County.
                                      Approximately 1,540             None        +3307
                                       feet upstream of Cobbs
                                       Creek Road (State Road
                                       1325).
Elk Creek...........................  Approximately 100 feet          None        +1349  Unincorporated Areas of
                                       downstream of the                                  Watauga County.
                                       Watauga/Wilkes County
                                       boundary.
                                      Approximately 1.1 miles         None        +2135
                                       upstream of Jakes
                                       Mountain Road.
Elk Creek (into South Fork River)...  Approximately 50 feet           None        +2955  Unincorporated Areas of
                                       upstream of Big Hill                               Watauga County.
                                       Road (State Road 1350).
                                      Approximately 250 feet          None        +2982
                                       upstream of State Road
                                       194.
Flannery Fork.......................  At the confluence with          None        +3253  Unincorporated Areas of
                                       Winkler Creek.                                     Watauga County, Town
                                                                                of Boone.
                                      Approximately 430 feet          None        +3469
                                       upstream of Sky Ranch
                                       Road.
Gap Creek...........................  At the Watauga/Ashe             None        +2952  Unincorporated Areas of
                                       County boundary.                                   Watauga County.
                                      Approximately 160 feet          None        +3076
                                       upstream of James
                                       Parsons Road.
Hodges Creek........................  Approximately 430 feet         +3126        +3127  Town of Boone.
                                       upstream of the
                                       confluence with Boone
                                       Creek.
                                      Approximately 140 feet          None        +3286
                                       upstream of NC 105
                                       Highway.
Howard Creek........................  Approximately 1,440             None        +3212  Unincorporated Areas of
                                       feet upstream of Moss                              Watauga County.
                                       Hill Road.
                                      Approximately 0.6 mile          None        +3418
                                       upstream of Millers
                                       Pond Lane.
Left Prong Stony Fork...............  At the Watauga/Wilkes           None        +1639  Unincorporated Areas of
                                       County boundary.                                   Watauga County.
                                      Approximately 220 feet          None        +1947
                                       upstream of the
                                       confluence of Wildcat
                                       Creek.
Meat Camp Creek.....................  At the confluence with         +3057        +3058  Unincorporated Areas of
                                       South Fork New River.                              Watauga County.
                                      Approximately 1.1 miles         None        +3495
                                       upstream of Bryan
                                       Hollow Road (State
                                       Road 1339).
Meat Camp Creek Tributary...........  At the confluence with          None        +3156  Unincorporated Areas of
                                       Meat Camp Creek.                                   Watauga County.
                                      Approximately 1,160             None        +3213
                                       feet upstream of NC
                                       194 Highway North.
Middle Fork.........................  Approximately 500 feet         +3458        +3455  Unincorporated Areas of
                                       downstream of Shoppes                              Watauga County, Town
                                       On The Parkway Road.                               of Blowing Rock.
                                      Approximately 0.4 mile          None        +3630
                                       upstream of Goforth
                                       Road.

Norris Fork.........................  At the confluence with          None        +3200  Unincorporated Areas of
                                       Meat Camp Creek.                                   Watauga County.
                                      Approximately 0.4 mile          None        +3248
                                       upstream of the
                                       confluence with Meat
                                       Camp Creek.
Pine Orchard Creek..................  At the confluence with          None        +2974  Unincorporated Areas of
                                       Elk Creek (into South                              Watauga County.
                                       Fork New River).
                                      Approximately 0.7 mile          None        +3041
                                       upstream of the
                                       confluence with Elk
                                       Creek (into South Fork
                                       New River).
Stony Fork..........................  At the Watauga/Wilkes           None        +1975  Unincorporated Areas of
                                       County boundary.                                   Watauga County.
                                      Approximately 40 feet           None        +2265
                                       downstream of Stoney
                                       Fork Road.
Stony Fork Tributary................  At the confluence with          None        +2260  Unincorporated Areas of
                                       Stony Fork.                                        Watauga County.
                                      Approximately 1,470             None        +2341
                                       feet upstream of
                                       Stoney Fork Road.
Unnamed Tributary to Middle Fork....  At the confluence with         +3479        +3477  Unincorporated Areas of
                                       Middle Fork.                                       Watauga County, Town
                                                                                of Blowing Rock.
                                      Approximately 0.7 mile          None        +3546
                                       upstream of Chetola
                                       Lake Drive.
Wildcat Creek.......................  At the confluence with          None        +1941  Unincorporated Areas of
                                       Left Prong Stony Fork.                             Watauga County.
                                      Approximately 0.6 mile          None        +2469
                                       upstream of Bill
                                       Miller Lane.
Winkler Creek.......................  Approximately 150 feet         +3114        +3113  Unincorporated Areas of
                                       downstream of Pride                                Watauga County, Town
                                       Drive.                                             of Boone.
                                      Approximately 300 feet          None        +3442
                                       upstream of Rainbow
                                       Mountain Road.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

Town of Blowing Rock

Maps are available for inspection at Blowing Rock Town Hall, 1036 Main Street, Blowing Rock, NC.

Town of Boone

Maps are available for inspection at Town of Boone Planning and Inspections Office, 1500 Blowing Rock Road,
 Boone, NC.

                                     Unincorporated Areas of Watauga County

Maps are available for inspection at Watauga County Planning and Inspections Department, 331 Queen Street, Suite
                                                  8, Boone, NC.
----------------------------------------------------------------------------------------------------------------
                               Grant County, South Dakota, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
South Fork Whetstone River..........  Approximately 48 feet           None        +1116  City of Milbank,
                                       upstream of 479th                                  Unincorporated Areas
                                       Avenue.                                            of Grant County.
                                      Approximately 790 feet          None        +1132
                                       upstream of North
                                       Dakota Street.
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

City of Milbank

Maps are available for inspection at Milbank City Offices, 1001 East 4th Avenue, Milbank, SD.

                                      Unincorporated Areas of Grant County

Maps are available for inspection at Grant County Courthouse, 210 East 5th Avenue, Milbank, SD.
----------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: September 4, 2008.
Michael K. Buckley,
Deputy Assistant Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
 [FR Doc. E8-21687 Filed 9-16-08; 8:45 am]

BILLING CODE 9110-12-P


[Federal Register: May 20, 2010 (Volume 75, Number 97)]
[Notices]
[Page 28245-28247]
[DOCID:fr20my10-37]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-New England Region I--EPA-R01-OW-2010-0318; FRL-9153-4]

Massachusetts Marine Sanitation Device Standard--Receipt of
Petition

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice--Receipt of Petition.

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SUMMARY: Notice is hereby given that a petition has been received from
the Commonwealth of Massachusetts requesting a determination by the
Regional Administrator, U.S. Environmental Protection Agency, that
adequate facilities for the safe and sanitary removal and treatment of
sewage from all vessels are reasonably available for the waters of
Gloucester, Rockport, Essex, Ipswich, Rowley, Newbury, Newburyport,
Salisbury, Amesbury, West Newbury, Merrimac, Groveland, North Andover,
Haverhill, Methuen, and Lawrence, collectively termed the Upper North
Shore for the purpose of this notice.

DATES: ``Comments must be submitted by June 21, 2010.''

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OW-2010-0318, by one of the following methods:
     http://www.regulations.gov. Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
    Mail and hand delivery: U.S. Environmental Protection Agency--New
England Region, Five Post Office Square, Suite 100, OEP06-1, Boston, MA
02109-3912. Deliveries are only accepted during the Regional Office's

normal hours of operation (8 a.m.-5 p.m., Monday through Friday,
excluding legal holidays), and special arrangements should be made for
deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R01-OW-
2010-0318. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online 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 http://
www.regulations.gov, or e-mail. The http://www.regulations.gov Web site
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 http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public 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 http://
www.regulations.gov index. 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, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the U.S. Environmental
Protection Agency--New England Region, Five Post Office Square, Suite
100, OEP06-01, Boston, MA 02109-3912. Such deliveries are only accepted
during the Regional Office's normal hours of operation, and special
arrangements should be made for deliveries of boxed information. The
Regional Office is open from 8 a.m.-5 p.m., Monday through Friday,
excluding legal holidays. The telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ann Rodney, U.S. Environmental
Protection Agency--New England Region, Five Post Office Square, Suite
100, OEP06-01, Boston, MA 02109-3912. Telephone:<PHONE_NUMBER>, Fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Notice is hereby given that a petition has
been received from the Commonwealth of Massachusetts requesting a
determination by the Regional Administrator, U.S. Environmental
Protection Agency, pursuant to Section 312(f)(3) of Public Law 92-500
as amended by Public Law 95-217 and Public Law 100-4, that adequate
facilities for the safe and sanitary removal and treatment of sewage
from all vessels are reasonably available for the Upper North Shore
area.
    The Upper North Shore No Discharge Area will encompass the coastal
waters for the cities and towns of Gloucester, Rockport, Essex,
Ipswich, Rowley, Newbury, Newburyport, Salisbury, Amesbury, West
Newbury, Merrimac, Groveland, North Andover, Haverhill, Methuen, and
Lawrence.
    The proposed No Discharge Area for the UPPER NORTH SHORE:

--------------------------------------------------------------------------------------------------------------------------------------------------------
         Waterbody/general area                 From  longitude              From latitude               To longitude                 To latitude
--------------------------------------------------------------------------------------------------------------------------------------------------------
The southern edge of the Upper North      70[deg]42'50'' W            42[deg]34'21'' N            70[deg]35'59'' W            42[deg]33'02'' N
 Shore NDA boundary is the Manchester/
 Gloucester municipal line at:
The northern edge of the Upper North      70[deg]48'47'' W            42[deg]52'19'' N            70[deg]43'57'' W            42[deg]52'35'' N
 Shore NDA boundary is MA/Seabrook, NH
 border at:
--------------------------------------------------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
            Waterbody/general area                         Longitude                         Latitude
----------------------------------------------------------------------------------------------------------------
On the Merrimack River, the inland edge of     71[deg]09'58'' W                  42[deg]42'02'' N
 the NDA boundary is at the Essex Dam in
 Lawrence at:
On the Parker River, the inland edge of the    70[deg]52'00'' W                  42[deg]45'20'' N
 NDA boundary is at the MBTA bridge in
 Newbury at:
On the Rowley River, the inland edge of the    70[deg]51'28'' W                  42[deg]43'19'' N
 NDA boundary is at the MBTA bridge on the
 Rowley/Ipswich town line at:
On the Ipswich River, the inland edge of the   70[deg]50'07'' W                  42[deg]40'44'' N
 NDA boundary is at County Street in Ipswich
 at:
On the Essex River, the inland edge of the     70[deg]46'43'' W                  42[deg]37'55'' N
 NDA boundary is at Main Street in Essex at:
The eastern edge of the boundary is
 contiguous with the state/federal line also
 known as the Submerged Lands Act boundary
 line and Territorial Sea boundary.
----------------------------------------------------------------------------------------------------------------

    The boundaries were chosen based on easy line-of-sight locations
and generally represent all navigational waters.
    There are marinas, yacht clubs and public landings/piers in the
proposed area with a combination of mooring fields and dock space for
the recreational and commercial vessels. Massachusetts has certified
that there are 13 pumpout facilities within the proposed area available
to the boating public. A list of the facilities, locations, contact
information, hours of operation, and water depth is provided at the end
of this petition.
    Massachusetts has provided documentation indicating that the total
vessel population is estimated to be 5,555 in the proposed area. It is
estimated that 1525 of the total vessel population may have a Marine
Sanitation Device (MSD) of some type.
    In the proposed area is the Great Marsh, one of the important
natural resources designated by the Commonwealth as an Area of Critical
Environmental Concern (ACEC) with 25,500 acres extending from Newbury
to Gloucester. The Great Marsh comprises the largest salt marsh system
(over 10,000 acres) north of Long Island, New York. The 2,900 acre
Parker River National Wildlife Refuge, within the ACEC, is known as an
important site on the Atlantic fly-way migration route. Over 300
species of birds have been sighted here, including 75 rare species.

    Six species of shellfish are harvested in the area, including soft-
shell clams, surf clams, blue mussels, razor clams, oysters, and ocean
quahogs. In 2007 and 2008, two million pounds of shellfish were
harvested in Greater Essex with a value of $2.5 million for the
communities of Gloucester, Essex, and Ipswich.
    The coastal area along the Upper North Shore of Massachusetts is
important for the tourism and recreation industries of the region,
including Salisbury Beach State Reservation, Sandy Point State
Reservation, Halibut Point State Park, Maudslay State Park, and more
than 25 marinas or boat yards are adjacent to the proposed NDA. This
area is a popular destination for boaters due to its natural
environmental diversity and would benefit from a No Discharge Area.

Pumpout Facilities Within Proposed No Discharge Area

                                                Upper North Shore
----------------------------------------------------------------------------------------------------------------
                                                                                Mean low water
              Name                     Location          Contact info.           Hours               depth
----------------------------------------------------------------------------------------------------------------
Gloucester Cape Ann Marina......  75 Essex Ave,<PHONE_NUMBER> VHF    8am-4pm...........  6 ft.
                                   Annisquam River.    10.
Gloucester Harbormaster.........  19 Harbor Loop....<PHONE_NUMBER> VHF    On call...........  N/A.
                                                       16.
Rockport Harbormaster...........  34 Broadway.......<PHONE_NUMBER> VHF    On call...........  N/A.
                                                       9, 16.
Ipswich Harbormaster............  15 Elm Street,<PHONE_NUMBER> VHF    On call...........  N/A.
                                   Plum Island Sound.  9, 16.
Rowley Harbormaster.............  497 Main Street...  VHF 9.............  Thur-Tue 10am-6pm.  NA.
Rowley Perley's Marina..........  109 Warehouse Lane<PHONE_NUMBER> VHF    Mon-Fri 8am-6pm;    4 ft.
                                                       9, 16.              Sat--Sun 8am-5pm.
Newbury Riverfront Marina.......  292 High Road.....<PHONE_NUMBER> VHF 9  8am-5pm (6pm        4 ft.
                                                                           weekend).
Newburyport Cashman Park........  Merrimack River...<PHONE_NUMBER> VHF    Self Service        6 ft.
                                                       12, 16.             Memorial Day/End
                                                                           of October.
Newburyport Harbormaster........  60 Pleasant Street<PHONE_NUMBER> VHF    Fri 1pm-5pm; Sat,   N/A.
                                                       12, 16.             Sun & Holidays
                                                                           9am-5pm.
Amesbury Marina at Hatter's       60 Merrimac Street<PHONE_NUMBER> VHF 9  8am-9pm...........  4 ft.
 Point.
West Newbury Harbormaster.......  Merrimack River<PHONE_NUMBER> VHF    On call 9am-5pm...  NA.
                                   Town Dock.          9, 16.
Salisbury Harbormaster..........  Town Wharf........<PHONE_NUMBER> VHF    On call...........  NA.
                                                       12.
----------------------------------------------------------------------------------------------------------------

    Dated: May 13, 2010.
Ira W. Leighton,
Acting Regional Administrator, New England Region.
[FR Doc. 2010-12118 Filed 5-19-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 8, 2010 (Volume 75, Number 25)]
[Notices]
[Page 6250]
[DOCID:fr08fe10-106]

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 DEPARTMENT OF TRANSPORTATION

ITS Joint Program Office; Intelligent Transportation Systems
Program Advisory Committee; Notice of Meeting

AGENCY: Research and Innovative Technology Administration, U.S.
Department of Transportation.

ACTION: Notice.

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    This notice announces, pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (FACA) (Pub. L. 72-363; 5 U.S.C. app. 2), a
meeting by Web conference of the Intelligent Transportation Systems
(ITS) Program Advisory Committee (ITSPAC). The Web conference will be
held on February 24, 2010, from 3 p.m. to 4 p.m.
    The ITSPAC, established under Section 5305 of Public Law 109-59,
Safe, Accountable, Flexible, Efficient Transportation Equity Act: A
Legacy for Users, August 10, 2005, and re-chartered on February 7,
2010, was created to advise the Secretary of Transportation on all
matters relating to the study, development, and implementation of
intelligent transportation systems. Through its sponsor, the ITS Joint
Program Office, the ITSPAC makes recommendations to the Secretary
regarding ITS Program needs, objectives, plans, approaches, content,
and progress.
    The following is a summary of the Web conference tentative agenda:
(1) Welcome by RITA Deputy Administrator; (2) Meeting purpose and
agenda review; (3) Overview of ITSPAC purpose, roles, and
responsibilities; (4) Overview of the ITS Joint Program Office
organization, management, and proposed mission; (5) Overview of the ITS
Five-Year Strategic Research Plan; and (6) Brief ethics review.
    Participation in the Web conference is open to the public, but
limited conference lines will be available on a first come, first
served basis. Members of the public who wish to participate must notify
Mr. Stephen Glasscock, the Committee Designated Federal Official, at
(202) 366-9126 not later than February 18, 2010, at which time the Web
conference URL and teleconference phone number will be provided.
Members of the public may present oral statements at the meeting with
the approval of Ms. Shelley Row, Director of the ITS Joint Program
Office. Non-committee members wishing to present oral statements or
obtain information should contact Mr. Glasscock.
    Questions about the agenda or written comments may be submitted by
U.S. Mail to: U.S. Department of Transportation, Research and
Innovative Technology Administration, ITS Joint Program Office,
Attention: Stephen Glasscock, 1200 New Jersey Avenue, SE., HOIT,
Washington, DC 20590 or faxed to<PHONE_NUMBER>. The ITS Joint Program
Office requests that written comments be submitted prior to the
meeting.
    Notice of this meeting is provided in accordance with the FACA and
the General Services Administration regulations (41 CFR part 102-3)
covering management of Federal advisory committees.

    Issued in Washington, DC, on the 2nd day of February 2010.
Shelley Row,
Director, ITS Joint Program Office.
[FR Doc. 2010-2649 Filed 2-5-10; 8:45 am]
BILLING CODE 4910-HY-P


Hi, Barbara and Jessica:  We, in BEAD, do not expect that the addition of existing crops on to a new formulation will affect the Abamectin SLUA (PCT) numbers in the future.   Please let Sepehr, Don and I know if you all have additional questions/comments.  Steve<PHONE_NUMBER>


[Federal Register: July 5, 2007 (Volume 72, Number 128)]
[Notices]
[Page 36742]
[DOCID:fr05jy07-138]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55991/File No. S7-12-01]

Order Extending Temporary Exemption of Banks From the Definition
of ``Broker'' Under Section 3(a)(4) of the Securities Exchange Act of
1934

June 29, 2007.

I. Background

    The Gramm-Leach-Bliley Act (``GLBA'') repealed the blanket
exception of banks from the definitions of ``broker'' and ``dealer''
under the Securities Exchange Act of 1934 (``Exchange Act'') \1\ and
replaced it with functional exceptions incorporated in amended
definitions of ``broker'' and ``dealer.'' Under the GLBA, banks that
engage in securities activities either must conduct those activities
through a registered broker-dealer or ensure that their securities
activities fit within the terms of a functional exception to the
amended definition of ``broker.''
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    \1\ As defined in Exchange Act Sections 3(a)(4) and 3(a)(5) [15
U.S.C. 78c(a)(4) and 78c(a)(5)].
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    The GLBA provided that the amended definitions of ``broker'' and
``dealer'' were to become effective May 12, 2001. Starting on May 11,
2001, in connection with various rulemaking proposals,\2\ the
Securities and Exchange Commission (``Commission'') extended, most
recently until July 2, 2007, a temporary exemption that gave banks time
to come into full compliance with the more narrowly-tailored exceptions
from broker-dealer registration under the GLBA.\3\
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    \2\ See Definition of Terms in and Specific Exemptions for
Banks, Savings Associations, and Savings Banks Under Sections
3(a)(4) and 3(a)(5) of the Securities Exchange Act of 1934, Exchange
Act Release No. 44291 (May 11, 2001), 66 FR 27760 (May 18, 2001)
(the ``Interim Rules''). See also Exchange Act Release No. 49879
(June 17, 2004), 69 FR 39682 (June 30, 2004) (``Regulation B''). In
the Interim Rules, the Commission adopted Exchange Act Rule 15a-7,
17 CFR 240.15a-7, which, as proposed to be amended, would provide
banks and other financial institutions until January 1, 2006, to
begin complying with the GLBA. In proposing Regulation B, the
Commission proposed Rule 781 as a re-designation of Rule 15a-7. See
17 CFR 242.781.
    \3\ See Exchange Act Release No. 44570 (July 18, 2001); Exchange
Act Release No. 45897 (May 8, 2002); Exchange Act Release No. 46751
(Oct. 30, 2002); Exchange Act Release No. 47649 (April 8, 2003);
Exchange Act Release No. 50618 (Nov. 1, 2004); Exchange Act Release
No. 51328 (March 8, 2005); Exchange Act Release No. 52405 (Sept. 9,
2005); Exchange Act Release No. 54544 (September 29, 2006), 71 FR
58891 (October 5, 2006) (extending the exemption from the definition
of ``broker'' until January 15, 2007); and Exchange Act Release No.
34-54948 (Dec. 18, 2006), 71 FR 247 (Dec. 18, 2006) (extending the
exemption from the definition of ``broker'' until July 2, 2007);
During this time, the Commission also extended the temporary
exemption from the definition of ``dealer'' to September 30, 2003.
See Exchange Act Release No. 47366 (Feb. 13, 2003). On February 13,
2003, the Commission adopted amendments to certain parts of the
Interim Rules that define terms used in the dealer exceptions, as
well as certain dealer exemptions (``Dealer Release''), see Exchange
Act Release No. 47364 (Feb. 13, 2003), 68 FR 8686 (Feb. 24, 2003).
Therefore, this order is limited to an extension of the temporary
exemption from the definition of ``broker.''
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    On October 13, 2006, President Bush signed into law the Financial
Services Regulatory Relief Act of 2006 (``Regulatory Relief Act'').\4\
Among other things, the Regulatory Relief Act requires the Commission
and the Board of Governors of the Federal Reserve (``Board'') jointly
to adopt final rules implementing the bank broker exceptions in Section
3(a)(4) of the Exchange Act.\5\ It also requires the Commission and the
Board jointly to issue proposed rules within 180 days of passage of the
Regulatory Relief Act.\6\
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    \4\ Pub. L. 109-351, 120 Stat. 1966 (2006).
    \5\ The Regulatory Relief Act also directs the Commission and
the Board to consult with and seek the concurrence of the other
Federal banking agencies on the content of the rulemaking. Section
101(c) of the Exchange Act defines the term ``Federal banking
agencies'' as ``the Office of the Comptroller of the Currency, the
Office of Thrift Supervision, and the Federal Deposit Insurance
Corporation.'' In another provision of the Regulatory Relief Act,
Congress extended the bank exceptions and exemptions to thrifts by
amending the definition of ``bank'' in Exchange Act Section 3(a)(6).
    \6\ Under the Regulatory Relief Act, a final single set of rules
or regulations jointly adopted in accordance with that Act shall
supersede any other proposed or final rule issued by the Commission
on or after the date of enactment of Section 201 of the GLBA with
regard to the definition of ``broker'' under Exchange Act Section
3(a)(4).
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    Consistent with the Regulatory Relief Act, on December 18, 2006,
the Commission and the Board jointly proposed implementing rules, which
were designated as Regulation R.\7\ At that time, the Commission also
granted banks \8\ an exemption from compliance with the definition of
broker until July 2, 2007 in order to permit the Commission and the
Board time to receive and evaluate comments and to take final action on
the implementing rules.
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    \7\ See Exchange Act Release No. 54946 (Dec. 18, 2006), 71 FR
77522 (Dec. 26, 2006).
    \8\ Section 401 of the Regulatory Relief Act also amended the
definition of ``bank'' in Section 3(a)(6) of the Exchange Act to
include any Federal savings association or other savings association
the deposits of which are insured by the FDIC. Accordingly, as used
in this order, the term ``bank'' includes any savings association
that qualifies as a ``bank'' under Section 3(a)(6) of the Exchange
Act, as amended.
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    To date, the Commission and the Board have received over 70
comments on proposed Regulation R. The Commission and the Board are
carefully considering the comments, in consultation with the other
Federal banking agencies, and expect to take final action on proposed
Regulation R shortly.

II. Extension of Temporary Exemption From Definition of ``Broker''

    In light of the need to carefully consider, together with the Board
and the other Federal banking agencies, the comments on proposed
Regulation R, the Commission finds that extending the temporary
exemption for banks from the definition of ``broker'' until September
28, 2007 is necessary and appropriate in the public interest, and is
consistent with the protection of investors. The extension of this
temporary exemption will prevent banks from incurring interim business
disruption, as well as interim implementation and compliance costs
before the Commission and the Board jointly adopt final implementing
rules. It will also provide the Commission and the Board time fully to
consider the comments, consult with and seek the concurrence of the
other Federal banking regulators, and take final action on the
proposal.

III. Conclusion

    Accordingly, pursuant to Section 36 of the Exchange Act,\9\ it is
hereby ordered that banks are exempt from the definition of the term
``broker'' under the Exchange Act until September 28, 2007.
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    \9\ 15 U.S.C. 78mm.

    By the Commission.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-13058 Filed 7-3-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 246 (Thursday, December 22, 2011)]
[Notices]
[Pages 79697-79701]
[FR Doc No: 2011-32775]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-1977-N-0019 (formerly 1977N-0230), FDA-1977-N-0014
(formerly 977N-0231), FDA-1977-N-0022 (formerly 1977N-0316), and FDA-
1977-N-0224 (formerly 1977N-0317)]

Withdrawal of Notices of Opportunity for a Hearing; Penicillin
and Tetracycline Used in Animal Feed

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
withdrawing two 1977 notices of opportunity for a hearing (NOOH), which
proposed to withdraw certain approved uses of penicillin and
tetracyclines intended for use in feeds for food-producing animals
based in part on microbial food safety concerns.\1\ (Refs. 1 and 2) FDA
is taking this action, and closing the corresponding dockets, because:
FDA is engaging in other ongoing regulatory strategies developed since
the publication of the 1977 NOOHs with respect to addressing microbial
food safety issues; FDA would update the NOOHs to reflect current data,
information, and policies if, in the future, it decides to move forward
with withdrawal of the approved uses of the new animal drugs described
in the NOOHs; and FDA would need to prioritize any withdrawal
proceedings (for example, take into account which withdrawal(s) would
likely have the most significant impact on the public health) if, in
the future, it decides to seek withdrawal of the approved uses of any
new animal drug or class of drugs. FDA is also withdrawing the
companion proposed rules to these NOOHs. (Refs. 3 and 4)
---------------------------------------------------------------------------

    \1\ FDA's approval to withdraw the approved uses of the drugs
was based on three statutory grounds: (1) The drugs are not shown to
be safe (21 U.S.C. 360b(e)(1)(B)); (2) lack of substantial evidence
of effectiveness (21 U.S.C. 360b(e)(1)(C)); and (3) failure to
submit required reports (21 U.S.C. 360b(e)(2)(A)).

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DATES: This notice is effective December 22, 2011.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFV-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: William Flynn, Center for Veterinary
Medicine (HFV-1), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Questions regarding the use of antimicrobial drugs in food-
producing animals have been raised and debated for many years. (Ref. 5)
\2\ Following a report that was issued by the British government in
1969 on the use of antibiotics in veterinary medicine and animal
husbandry, known as the ``Swann Report,'' the Commissioner of Food and
Drugs established a task force to review the use of antibiotic drugs in
animal feeds. The task force, established in 1970, included specialists
on infectious diseases and animal science from FDA, the National
Institutes of Health, the U.S. Department of Agriculture, and the
Centers for Disease Control and Prevention, as well as representatives
from universities and industry. The task force identified three primary
areas of concern (human health hazard, animal health hazard, and
antibiotic effectiveness) and guidelines were established to show
whether the use of any antibiotic or antibacterial agent in animal feed
presents a hazard to human and animal health. (Refs. 1 and 6) The task
force also made certain recommendations concerning restrictions on the
use of antibiotic drugs in animal feeds at growth promotion and
subtherapeutic levels. (Ref. 6)
---------------------------------------------------------------------------

    \2\ The term ``antimicrobial'' refers broadly to drugs with
activity against a variety of microorganisms including: Bacteria,
viruses, fungi, and parasites. Antimicrobial drugs that have
specific activity against bacteria are referred to as antibacterial
or antibiotic drugs. However, the broader term ``antimicrobial,''
commonly used in reference to drugs with activity against bacteria,
is used in this document interchangeably with the terms
antibacterial or antibiotic. Antimicrobial resistance is the ability
of bacteria or other microbes to resist the effects of a drug.
Antimicrobial resistance, as it relates to bacterial organisms,
occurs when bacteria change in some way that reduces or eliminates
the effectiveness of drugs, chemicals, or other agents designed to
treat bacterial infections. (Ref. 5)
---------------------------------------------------------------------------

    In 1972, FDA published the conclusions and recommendations of that
task force and proposed to require sponsors to submit specific data for
antibiotic drugs in animal feeds intended for subtherapeutic or growth
promotion use when such drugs are also used in human clinical medicine.
(Ref. 6) In 1973, FDA finalized this proposal in 21 CFR 135.109 (re-
codified at 21 CFR 558.15 in 1974).\3\ (Refs. 7, 8, and 9) This section
provided that FDA would propose to revoke approved uses in animal feed
of antibiotic and sulfonamide drugs unless certain data were submitted
which satisfactorily addressed the outstanding safety and effectiveness
issues.
---------------------------------------------------------------------------

    \3\ Since that time, portions of 21 CFR 558.15 have been removed
because those portions of the regulation were determined to be
redundant or obsolete. (See 75 FR 16001, March 31, 2010.)
---------------------------------------------------------------------------

    By 1974, FDA had begun to review the data submitted by the sponsors
of the antibiotic products and requested that the National Advisory
Food and Drug Committee (NAFDC) review the data and make
recommendations on the subtherapeutic uses of penicillin and
tetracyclines. A subcommittee (the Antibiotics in Animal Feeds
subcommittee) was appointed to work in conjunction with expert
consultants to address these issues. With respect to the penicillin-
containing drugs, the subcommittee recommended FDA immediately withdraw
approval of the subtherapeutic uses of penicillin. The

NAFDC accepted the subcommittee's recommendation and recommended to FDA
that it ``immediately withdraw approval for the subtherapeutic uses of
penicillin, i.e., growth promotion/feed efficiency, and disease
control.'' \4\ (Ref. 1) FDA accepted these recommendations. (Ref. 1)
---------------------------------------------------------------------------

    \4\ Generally, FDA no longer considers disease control or
prevention to be subtherapeutic uses.
---------------------------------------------------------------------------

    With respect to the tetracycline-containing drugs, the subcommittee
recommended that FDA: (1) Discontinue use for growth promotion and/or
feed efficiency in all animal species for which effective substitutes
are available; (2) permit their use for disease control where effective
alternate drugs are unavailable; and (3) control the distribution of
the tetracyclines to restrict their use. NAFDC did not accept the
subcommittee's first two recommendations, and instead recommended that
FDA make no changes in the permitted use of chlortetracycline and
oxytetracycline in animal feed. (Ref. 2) The NAFDC did adopt the
subcommittee's third recommendation that the addition of the
tetracycline in feeds be restricted. (Ref. 2) FDA considered these
recommendations and decided to propose withdrawal of approval of
subtherapeutic uses of tetracyclines in animal feeds except for those
conditions of use for which there are no safe and effective
substitutes. (Ref. 2)
    This process culminated in the 1977 publication of two NOOHs in the
Federal Register on proposals by the Bureau of Veterinary Medicine (now
Center for Veterinary Medicine) to withdraw all uses of penicillin in
animal feed, and all subtherapeutic uses of tetracycline in animal feed
except for: (1) Oxytetracyline, as an aid in the control of fowl
cholera caused by Pasteurella multocida in chickens and infectious
synovitis caused by Mycoplama synoviae in chickens and turkeys; and (2)
chlortetracycline (a) as an aid in the maintenance of weight gains in
the presence of respiratory diseases, such as shipping fever, in
combination with sulfamethazine in beef cattle, (b) as an aid in the
control of infectious synovitis caused by M. pasteurella in chickens
and turkeys, (c) for the control of active infections of anaplasmosis
in beef cattle, and (d) as an aid in reducing the incidence of
virbrionic abortion in breeding sheep. (Ref. 1 and 2) \5\ These NOOHs
were published on August 30, 1977 (penicillin) and October 21, 1977
(tetracycline).
---------------------------------------------------------------------------

    \5\ These matters were assigned Docket Numbers 77N-0230 and 77N-
0316, respectively. Since the original dockets were opened, FDA
started using a different numbering convention. Docket Number 77N-
0230 is now Docket Number FDA-1977-N-0019, and Docket Number 77N-
0316 is now Docket Number FDA-1977-N-0022.
---------------------------------------------------------------------------

    At the same time, FDA also published two companion proposed rules
proposing to amend the regulations to delete those provisions
referencing the approved penicillin and tetracycline uses that would be
affected by a withdrawal. (Refs. 3 and 4) FDA did not withdraw any
approved use of penicillin or tetracyclines intended for use in feeds
for food-producing animals as a result of these NOOHs, or finalize the
proposed companion rules, and some new animal drug approvals for the
use of these new animal drugs in feeds for food-producing animals
remain in effect.
    Although FDA initially granted some hearing requests to provide
sponsors with the opportunity to present evidence on the safety of the
NOOH products, Congress intervened before any hearing was held,
directing FDA to hold in abeyance the implementation of its proposed
withdrawal actions pending the outcome of further research related to
the use of antibiotics in animal feed. (Refs. 10, 11, and 12)

II. Discussion

    At this time, FDA is withdrawing the 1977 NOOHs because: (1) FDA is
engaging in other ongoing regulatory strategies developed since the
publication of the 1977 NOOHs with respect to addressing microbial food
safety issues; (2) FDA would update the NOOHs to reflect current data,
information, and policies if, in the future, it decides to move forward
with withdrawal of the approved uses of the new animal drugs described
in the NOOHs; and (3) FDA would need to prioritize any withdrawal
proceedings (for example, take into account which withdrawal(s) would
likely have the most significant impact on the public health) if, in
the future, it decides to seek withdrawal of the approved uses of any
new animal drug or class of drugs.
    Although FDA is withdrawing the 1977 NOOHs, FDA remains concerned
about the issue of antimicrobial resistance. Today's action should not
be interpreted as a sign that FDA no longer has safety concerns or that
FDA will not consider re-proposing withdrawal proceedings in the
future, if necessary. FDA has not ruled out the prospect of future
regulatory action, either with respect to the antimicrobial new animal
drugs covered by the 1977 NOOHs or any others. However, as discussed
further in this document, FDA intends to focus its efforts for now on
the potential for voluntary reform and the promotion of the judicious
use of antimicrobials in the interest of public health. Importantly,
this strategy leaves open the possibility of pursuing withdrawal
proceedings at a later time if FDA's proposed strategy does not yield
satisfactory results.

1. FDA Is Engaging in Other Ongoing Regulatory Strategies Developed
Since the Publication of the 1977 NOOHs With Respect to Addressing
Microbial Food Safety Issues

    Since the 1977 NOOHs published, FDA has continued to investigate
the safety concerns associated with subtherapeutic uses of antibiotics
intended for use in feeds for food-producing animals. As mentioned
previously, Congress directed FDA to hold proceedings with respect to
the 1977 NOOHs in abeyance and instead to conduct more research on the
issues in question. (Ref. 10, 11, and 12) In response, FDA contracted
with the National Academy of Sciences (NAS) to conduct a study of the
safety issues related to the use of antibiotics in animal feed. (Refs.
5 and 13) In particular, FDA asked the NAS to: (1) Study the human
health effects of the subtherapeutic use of penicillin and tetracycline
in animal feed; (2) review and analyze published and unpublished
epidemiological and other data necessary to assess human health
consequences of such use; (3) assess the scientific feasibility of
additional epidemiological studies; and (4) make recommendations about
additional research needed. (Refs. 5 and 9)
    The NAS issued its report in 1980, concluding that a very limited
amount of epidemiological research had been completed on either the
subtherapeutic or therapeutic use of antimicrobials in animal feeds and
that existing data could neither prove nor disprove the postulated
hazards to human health from subtherapeutic antimicrobial use in animal
feed. (Refs. 5 and 9) The report stated that ``[t]he lack of data
linking human illness with subtherapeutic levels of antimicrobials must
not be equated with proof that the proposed hazards do not exist. The
research necessary to establish and measure a definitive risk has not
been conducted and, indeed, may not be possible.'' (Refs. 5 and 13)
    In 1984, FDA contracted with the Seattle-King County Health
Department to complete a study intended to provide additional
information regarding potential public health concerns regarding the
use of antimicrobial drugs in animal feed. The study focused on

the relationship between the occurrence of Salmonella spp. (Salmonella)
and Campylobacter jejuni (C. jejuni) in foods of animal origin and the
occurrence of human illness caused by those two organisms. The study
report indicated that the bacteria obtained from human cases and those
obtained from retail poultry had similar antibiotic susceptibility
patterns, including similar levels of resistance to tetracycline.
(Refs. 5 and 14)
    In 1987, FDA asked the Institute of Medicine to conduct an
independent review of the human health risks associated with the
subtherapeutic uses of penicillin and tetracycline in animal feed.
(Refs. 5 and 15) The IOM established a committee which developed a
risk-analysis model using data on Salmonella infections that resulted
in human death. (Refs. 5 and 15) The Committee did not find a
substantial body of direct evidence establishing conclusively the
presence of a human health hazard resulting from the use of
subtherapeutic concentrations of penicillin and the tetracyclines in
animal feeds. (Refs. 5 and 15) Nonetheless, the Committee found a
considerable body of indirect evidence implicating both the
subtherapeutic and therapeutic use of antimicrobials as a potential
human health hazard, and made recommendations for further study of the
issue.\6\ (Refs. 5 and 15)
---------------------------------------------------------------------------

    \6\ FDA's draft guidance titled ``The Judicious Use of Medically
Important Antimicrobial Drugs in Food-Producing Animals'' (Draft GFI
209) contains information on additional key studies
relevant to this issue. For example, in 1997, the World Health
Organization (WHO) issued a report which concluded that all uses of
antimicrobials lead to the selection of resistant forms of bacteria
and that ``low-level, long-term exposure to antimicrobials may have
greater selective potential than short-term, full-dose therapeutic
use.'' (Ref. 17) The WHO report contained several recommendations,
including a recommendation that the use of antimicrobial drugs for
growth promotion in animals be terminated if these drugs are also
prescribed for use as anti-infective agents in human medicine or if
they are known to induce cross-resistance to antimicrobials used for
human medical therapy. (Ref. 17) It also recommended that national
practices of antimicrobial use in animals be reviewed, and policies
be developed to reduce the risks of selection and dissemination of
antimicrobial resistance. (Ref. 17) Further, in 1999 the National
Research Council issued a report that, among other things,
recommended that further development and use of antibiotics in both
human and animal medicine have oversight by an interdisciplinary
panel of experts. (Ref. 18)
---------------------------------------------------------------------------

    During the 1990's, FDA continued to investigate the potential risks
associated with the use of antibiotic drugs intended for use in feeds
for food-producing animals and how to mitigate risks associated with
such use. In 1999, FDA published a concept paper titled, ``Proposed
Framework For Evaluating and Assuring the Human Safety of the Microbial
Effects of Antimicrobial New Animal Drugs Intended for Use in Food-
Producing Animals'' (``Framework Document''). (Ref. 19) Among other
things, the Framework Document called for revisions to the pre-approval
safety assessment for antimicrobial new animal drugs, and the
categorization of antimicrobial drugs based on their importance to
human medicine. (Ref. 19)
    In 2003, FDA published a final guidance for industry (GFI
152), outlining an approach for conducting a qualitative risk
assessment to evaluate human food safety with respect to the potential
microbiological effects of antimicrobial new animal drugs on food-borne
bacteria of human health concern. (Ref. 20) The importance of a drug
for human medical therapy is a key factor to be considered in the
evaluation. (Ref. 20) Since 2003, FDA has applied the principles
contained in GFI 152 when assessing antimicrobial resistance
risks for antimicrobial drugs as part of the new animal drug approval
process. In some cases, this has had the effect of limiting the claims
for which such drugs are approved while still protecting animal and
human health.
    Recognizing that already-approved antimicrobial new animal drugs
also have antimicrobial resistance risks associated with their use, FDA
began to look at the safety of some of these already approved drugs.
However, because the process of reviewing safety information for
antimicrobial drugs approved before 2003 (and pursuing withdrawal
proceedings if appropriate in some cases) would take many years and
would impose significant resource demands on the Agency, FDA began
thinking about alternate approaches to address safety concerns. As a
result, in June 2010 FDA proposed a different strategy to promote the
judicious use of medically important antimicrobials in food-producing
animals in a draft guidance for industry titled ``The Judicious Use of
Medically Important Antimicrobial Drugs in Food-Producing Animals''
(draft GFI 209). (Ref. 5) Generally speaking, judicious uses
would be those uses that are appropriate and necessary to maintaining
the health of humans and animals.
    Draft GFI 209 proposes two principles aimed at ensuring
the judicious use of medically important antimicrobials in food-
producing animals. The first principle described in the draft guidance
is that the use of medically important antimicrobial drugs in food-
producing animals should be limited to those uses that are considered
necessary for assuring animal health. (Ref. 5) As set out in the draft
guidance, FDA does not consider production uses of such drugs to be
necessary for assuring animal health because, unlike other uses,
production uses are not directed at any specifically identified
disease, but rather are expressly indicated and used for the purpose of
enhancing the production of animal-derived products (e.g., promoting
faster weight gain or improving feed efficiency). (Ref. 5) The second
principle set out in the draft guidance is that the use of medically
important antimicrobial drugs in food-producing animals should be
limited to those uses that include veterinary oversight or
consultation. (Ref. 5) This principle speaks to the need for the
scientific and clinical training of licensed veterinarians to assure
that medically important antimicrobials are used in a judicious manner.
    Based on feedback the Agency received following the issuance of
draft GFI 209, FDA believes that the animal pharmaceutical
industry is generally responsive to the prospect of working
cooperatively with the Agency to accomplish the principles recommended
in draft GFI 209. FDA intends to work with sponsors who
approach FDA and are interested in working cooperatively with the
Agency to phase out production uses of medically important
antimicrobials, and to achieve an orderly transition of medically
important antimicrobials currently approved for over-the-counter use in
food-producing animals to a marketing status that involves veterinary
oversight (i.e., veterinary feed directive (VFD) status for feed use
drugs and prescription status for drugs approved for use through other
routes of administration).
    As part of the proposed strategy, FDA issued an advance notice of
proposed rulemaking (ANPRM) on March 29, 2010 (75 FR 15387), to seek
public comment on whether and to what extent efficiency improvements
should be made to the current VFD process as set forth in FDA's
regulation at 21 CFR 558.6. (Ref. 21) FDA received numerous public
comments in response to the ANPRM and is taking those comments into
account in considering possible revisions to this regulation.
    FDA believes that the strategy set out in draft GFI 209
represents another pathway to achieving the same goals contemplated by
the 1977 NOOHs, i.e., the judicious use of medically important
antimicrobial drugs. FDA believes that by implementing this strategy
and proceeding in part under the statutory authority provided under the
Animal

Drug Availability Act of 1996 (ADAA) \7\ to designate drugs as VFD
drugs (authority which was not available in 1977), it will achieve its
goal of promoting the judicious use of antimicrobial drugs in a more
timely and resource-efficient manner than could be accomplished
otherwise.\8\
---------------------------------------------------------------------------

    \7\ ADAA (Pub. L. 104-250), which was signed into law on October
9, 1996, introduced several amendments to the Federal Food, Drug,
and Cosmetic Act that provided FDA with more flexibility in how it
regulates animal drugs and animal feeds. One such amendment made by
the law was to add a new ``veterinary feed directive'' category of
new animal drugs to allow the approval and use of drugs in animal
feed on a veterinarian's order while incorporating safeguards to
help ensure the safe use of the drug.
    \8\ FDA's experience with contested, formal withdrawal
proceedings is that the process can consume extensive periods of
time and significant amounts of Agency resources. For example, when
FDA withdrew a class of animal drugs called nitrofurans in 1991, the
proceedings took nearly 20 years. In another proceeding, the
withdrawal of diethylstilbestrol (``DES'') in animals became final
in 1979, 7 years after issuance of an NOOH. More recently, the
withdrawal of enrofloxacin for use in poultry took almost 5 years
and cost FDA approximately $3.3 million.
---------------------------------------------------------------------------

2. FDA Would Update the NOOHs To Reflect Current Data, Information and
Policies If, in the Future, it Decides To Move Forward With the
Withdrawal of the Approved Uses of the New Animal Drugs Described in
the NOOHs

    Although FDA is optimistic that its proposed strategy to achieve
the judicious use of all medically important antimicrobials, as set out
in draft GFI 209, will be successful, it has not foreclosed
the possibility of using the withdrawal provisions in the Federal Food,
Drug, and Cosmetic Act, if necessary, in the future. This applies not
only to the classes of antimicrobial drugs covered by the 1977 NOOHs,
but also any other production use claims (i.e., growth promotion/feed
efficiency uses) for a medically important antimicrobial new animal
drug or class of drugs intended for use in food-producing animals.
However, if FDA were to pursue withdrawal of approval of any production
use claims, it would first publish a notice in the Federal Register
giving the sponsor(s) of the affected new animal drug(s) notice of the
proposed withdrawal(s) and an opportunity for a hearing.
    If, at some future time, FDA decides to proceed with the withdrawal
of the production uses of penicillins and tetracyclines intended for
use in feeds for food-producing animals that were the subject of the
1977 NOOHs, it would publish a new Federal Register notice giving
sponsors an opportunity for a hearing on the matter. A new notice would
be appropriate for many reasons. First, more than three decades have
passed since the original notice appeared in the Federal Register. FDA
would publish a new Federal Register notice to ensure all current
sponsors of the approved new animal drugs are properly notified and
have an opportunity to request a hearing.
    Second, not all uses proposed to be withdrawn in the 1977 NOOHs are
still approved. The 1977 NOOH which proposed withdrawal of all
penicillin-containing premixes intended for use in animal feed also
included the then-approved therapeutic uses of penicillin in feed. The
stated grounds for proposing to withdraw approval of the therapeutic
uses of the penicillin-containing premixes were that there was not
substantial evidence of effectiveness of these products for the claimed
therapeutic uses. However, there are no currently approved therapeutic
uses of penicillins in animal feed.
    Third, the body of scientific information relevant to the use of
penicillins and tetracyclines in animal feeds has grown since 1977. If
the Agency were to pursue the NOOHs, FDA would need to provide notice
to the sponsors that the information available since 1977 would be used
to support the proposal to withdraw the approved uses of the drugs.
    For example, in the early 1990's FDA began collaborating with other
government agencies to track antibiotic resistance in foodborne
bacteria through a national public health surveillance system, known as
the National Antimicrobial Resistance Monitoring System or ``NARMS,''
established to monitor antimicrobial susceptibility among enteric
bacteria from humans, retail meats, and food animals. (Ref. 22) Also,
since the 1977 NOOHs published, there have been numerous reports,
including those by the National Academy of Sciences (Ref. 13), the
Institute of Medicine (Ref. 15), the World Health Organization (Ref.
17), and the National Research Council (Ref. 18), that have reviewed
available information and made recommendations. In addition, there have
been advances in our understanding of the genetics of resistance (e.g.,
ways in which bacteria accumulate multiple resistance genes).
    Fourth, FDA would need to provide notice regarding which approved
uses were the subject of the NOOH. In the past, FDA has referred to
``subtherapeutic'' uses at various times to include: (1) ``Increased
rate of gain, disease prevention, etc.'' (Ref. 7); (2) ``any use of an
antibacterial drug continuously in feed for longer than 14 days'' (Ref.
23); and (3) ``lower levels than therapeutic levels needed to cure
disease.'' (Refs. 1 and 2) FDA's thinking on this issue has evolved
over the last three decades, and FDA now generally considers disease
control and prevention claims to be judicious uses (in other words,
therapeutic uses), especially when the drug is administered at the
direction and under the oversight of a licensed veterinarian. (Ref. 5)

3. FDA Would Need To Prioritize Any Withdrawal Proceedings (for
Example, Take Into Account Which Withdrawal(s) Would Likely Have the
Most Significant Impact on the Public Health) if, in the Future, It
Decides To Seek Withdrawal of the Approved Uses of Any New Animal Drug
or Class of Drugs

    To the extent that FDA decides to move forward with withdrawal
proceedings for any medically important antimicrobial drugs intended
for use in feeds for food-producing animals, it would need to
prioritize which withdrawal(s) to propose first based on various
considerations, including which withdrawal(s) would have the most
significant impact on the public health. It is possible that FDA would
conclude that its judicious use goals would better be achieved by first
pursuing withdrawals of drugs other than penicillins and tetracyclines.
FDA notes that it would need to conduct such an evaluation regardless
of the statutory grounds contemplated for the withdrawal action.

III. Conclusion

    At this time, FDA is withdrawing the 1977 NOOHs because: (1) FDA is
engaging in other ongoing regulatory strategies developed since the
publication of the 1977 NOOHs with respect to addressing microbial food
safety issues; (2) FDA would update the NOOHs to reflect current data,
information, and policies if, in the future, it decides to move forward
with withdrawal of the approved uses of the new animal drugs described
in the NOOHs; and (3) FDA would need to prioritize any withdrawal
proceedings (for example, take into account which withdrawal(s) would
likely have the most significant impact on the public health) if, in
the future, it decides to seek withdrawal of the approved uses of any
new animal drug or class of drugs.
    Although FDA is withdrawing the 1977 NOOHs, FDA continues to view
antimicrobial resistance as a significant public health issue. Today's
action should not be interpreted as a sign that FDA no longer has
safety concerns about the use of medically important antibiotics in
food producing animals or

that FDA will not consider re-proposing withdrawal proceedings in the
future, if necessary. FDA has not ruled out the prospect of future
regulatory action, either with respect to the antimicrobial new animal
drugs covered by the 1977 NOOHs or any others. However, for now, FDA's
efforts will focus on promoting voluntary reform and the judicious use
of antimicrobials in the interest of best using the agency's overall
resources to protect the public health. Importantly, this strategy
leaves open the possibility of pursuing withdrawal proceedings at a
later time if FDA's proposed strategy does not yield satisfactory
results.
    As indicated previously, as part of the withdrawal of the two 1977
NOOHs, the Agency will close their corresponding dockets. However, we
encourage interested persons to submit comments to the docket
established in connection with draft GFI 209. The docket
number associated with draft GFI 209 is FDA-2010-D-0094.

IV. Penicillin and Tetracycline Uses in Animal Feed

    FDA is withdrawing the 1977 NOOHs, and the related companion
proposed rules, because: (1) FDA is engaging in other ongoing
regulatory strategies developed since the publication of the 1977 NOOHs
with respect to addressing microbial food safety issues; (2) FDA would
update the NOOHs to reflect current data, information, and policies if,
in the future, it decides to move forward with withdrawal of the
approved uses of the new animal drugs described in the NOOHs; and (3)
FDA would need to prioritize any withdrawal proceedings (for example,
take into account which withdrawal(s) would likely have the most
significant impact on the public health) if, in the future, it decides
to seek withdrawal of the approved uses of any new animal drug or class
of drugs.

V. References

    The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20857, and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday (except on Federal
holidays). We have verified all Web site addresses, but we are not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.

    1. 42 FR 43772 (August 30, 1977).
    2. 42 FR 56264 (October 21, 1977).
    3. 42 FR 43770 (August 30, 1977).
    4. 42 FR 56254 (October 21, 1977).
    5. Draft GFI 209, ``The Judicious Use of Medically
Important Antimicrobial Drugs in Food-Producing Animals,'' June 28,
2010; http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM216936.pdf.
    6. 37 FR 2444 (February 1, 1972).
    7. 38 FR 9811 (April 20, 1973).
    8. 21 CFR 135.109 (revised as of April 1, 1974).
    9. 21 CFR 558.15 (revised as of April 1, 1975).
    10. H. Rept. 95-1290, ``Agriculture, Rural Development and
Related Agencies Appropriation Bill, 1979,'' June 13, 1978.
    11. H. Rept. 96-1095, ``Agriculture, Rural Development and
Related Agencies Appropriation Bill, 1981,'' June 17, 1980.
    12. S. Rept. 97-248, ``Agriculture, Rural Development and
Related Agencies Appropriation Bill, 1982,'' October 23 (legislative
day, October 14), 1981.
    13. National Academy of Sciences/National Research Council,
``The Effects on Human Health of Subtherapeutic Uses of
Antimicrobials in Animal Feeds,'' 1980, pp. 53-54.
    14. 1984 Seattle-King County Study: ``Surveillance of the Flow
of Salmonella and Campylobacter in a Community.''
    15. National Academy of Sciences/Institute of Medicine, ``Human
Health Risks With the Subtherapeutic Use of Penicillin or
Tetracyclines in Animal Feed,'' 1988.
    16. 68 FR 47272, 47275 (August 8, 2003).
    17. 1997 World Health Organization (WHO) Report, '' The Medical
Impact of Antimicrobial Use in Food Animals,'' http://whqlibdoc.who.int/hq/1997/WHO_EMC_ZOO_97.4.pdf
    18. 1999 National Research Council (NRC) Report: ``The Use of
Drugs in Food Animals-Benefits and Risks.''
    19. A Proposed Framework for Evaluating and Assuring the Human
Safety of the Microbial Effects of Antimicrobial New Animal Drugs
Intended for Use in Food-Producing Animals, http://www/fda/gov/
AdvisoryCommittees/CommitteesMeetingMaterials/
VeterinaryMedicineAdvisoryCommittee/ucm126607.htm.
    20. Final Guidance for Industry 152, ``Evaluating the
Safety of Antimicrobial New Animal Drugs With Regard to Their
Microbiological Effects on Bacteria of Human Health Concern,''
October 23, 2003.
    21. 75 FR 15387 (March 29, 2010).
    22. http://www/fda/gov/AnimalVeterinarySafetyHealth/
AntimicrobialResistance/
NationalAntimmicrobialResistanceMonitoringSystem/default.htm.
    23. 41 FR 8282 (February 25, 1976).

    Dated: December 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32775 Filed 12-21-11; 8:45 am]
BILLING CODE 4160-01-P