[Federal Register Volume 77, Number 146 (Monday, July 30, 2012)]
[Rules and Regulations]
[Pages 44498-44501]
[FR Doc No: 2012-18494]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 65

[Docket ID FEMA-2012-0003]

Changes in Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: Modified Base (1% annual-chance) Flood Elevations (BFEs) are
finalized for the communities listed below. These modified BFEs will be
used to calculate flood insurance premium rates for new buildings and
their contents.

DATES: The effective dates for these modified BFEs are indicated on the
following table and revise the Flood Insurance Rate Maps (FIRMs) in
effect

for the listed communities prior to this date.

ADDRESSES: The modified BFEs for each community are available for
inspection at the office of the Chief Executive Officer of each
community. The respective addresses are listed in the table below.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below of the modified BFEs
for each community listed. These modified BFEs have been published in
newspapers of local circulation and ninety (90) days have elapsed since
that publication. The Deputy Associate Administrator for Mitigation has
resolved any appeals resulting from this notification.
    The modified BFEs are not listed for each community in this notice.
However, this final rule includes the address of the Chief Executive
Officer of the community where the modified BFE determinations are
available for inspection.
    The modified BFEs are made pursuant to section 206 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The modified BFEs are the basis for the floodplain management
measures that the community is required either to adopt or to show
evidence of being already in effect in order to qualify or to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    These 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 modified BFEs are used to meet the floodplain management
requirements of the NFIP and also are used to calculate the appropriate
flood insurance premium rates for new buildings built after these
elevations are made final, and for the contents in those buildings. The
changes in BFEs are in accordance with 44 CFR 65.4.
    National Environmental Policy Act. This final 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.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This final rule involves no
policies that have federalism implications under Executive Order 13132,
Federalism.
    Executive Order 12988, Civil Justice Reform. This final rule meets
the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 65

    Flood insurance, Floodplains, Reporting and recordkeeping
requirements.

    Accordingly, 44 CFR part 65 is amended to read as follows:

PART 65--[AMENDED]

0
1. The authority citation for part 65 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.  65.4  [Amended]

0
2. The tables published under the authority of Sec.  65.4 are amended
as follows:

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                                                             Date and name of
         State and county           Location and case No.     newspaper where     Chief executive officer   Effective date of  modification   Community
                                                           notice was published         of community                                             No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama:
    Mobile (FEMA Docket No.: B-     City of Mobile (11-04- Nov. 10, 2011, Nov.   The Honorable Samuel L.    Mar. 16, 2012..................       015007
     1240).                          2597P).                17, 2011, The Press-  Jones, Mayor, City of
                                                            Register.             Mobile, 205 Government
                                                                                Street, South Tower,
                                                                                10th Floor, Mobile, AL
                                                                                36602.
    Mobile (FEMA Docket No.: B-     Unincorporated areas   Oct. 27, 2011, Nov.   The Honorable Merceria     Mar. 2, 2012...................       015008
     1235).                          of Mobile County (11-  3, 2011, The Press-   Ludgood, Chair, Mobile
                                     04-1739P).             Register.             County Commission, 205
                                                                                Government Street,
                                                                                Mobile, AL 36644.
Arizona:
    Coconino (FEMA Docket No.: B-   City of Flagstaff (11- Oct. 27, 2011, Nov.   The Honorable Sara         Mar. 2, 2012...................       040020
     1244).                          09-0801P).             3, 2011, The          Presler, Mayor, City of
                                                            Arizona Daily Sun.    Flagstaff, 211 West
                                                                                Aspen Avenue, Flagstaff,
                                                                                AZ 86001.
    Maricopa (FEMA Docket No.: B-   City of Peoria (11-09- Dec. 8, 2011, Dec.    The Honorable Bob          Nov. 29, 2011..................       040050
     1244).                          3985P).                15, 2011, The         Barrett, Mayor, City of
                                                            Arizona Business      Peoria, 8401 West Monroe
                                                            Gazette.              Street, Peoria, AZ 85345.
California:
    Orange (FEMA Docket No.: B-     City of Laguna Beach   Nov. 4, 2011, Nov.    The Honorable Toni         Mar. 12, 2012..................       060223
     1240).                          (11-09-3647P).         11, 2011, The         Iseman, Mayor, City of
                                                            Laguna Beach          Laguna Beach, 505 Forest
                                                            Coastline Pilot.      Avenue, Laguna Beach, CA
                                                                                92651.
    Santa Clara (FEMA Docket No.:   City of San Jose (12-  Dec. 2, 2011, Dec.    The Honorable Chuck Reed,  Dec. 22, 2011..................       060349
     B-1240).                        09-0140P).             9, 2011, The San      Mayor, City of San Jose,
                                                            Jose Mercury News.    200 East Santa Clara
                                                                                Street, San Jose, CA
                                                                                95113.
Colorado:
    Adams (FEMA Docket No.: B-      City of Commerce City  Oct. 25, 2011, Nov.   The Honorable Paul         Mar. 2, 2012...................       080006
     1235).                          (10-08-1048P).         1, 2011, The          Natale, Mayor, City of
                                                            Commerce City         Commerce City, 7887 East
                                                            Sentinel Express.     60th Avenue, Commerce
                                                                                City, CO 80022.

    El Paso (FEMA Docket No.: B-    City of Colorado       Nov. 2, 2011, Nov.    The Honorable Steve Bach,  Mar. 8, 2012...................       080060
     1240).                          Springs (11-08-        9, 2011, The El       Mayor, City of Colorado
                                     0869P).                Paso County           Springs, 30 South Nevada
                                                            Advertiser and News.  Avenue, Colorado
                                                                                Springs, CO 80903.
    El Paso (FEMA Docket No.: B-    Unincorporated areas   Nov. 2, 2011, Nov.    The Honorable Dennis       Mar. 8, 2012...................       080059
     1240).                          of El Paso County      9, 2011, The El       Hisey, Chairman, El Paso
                                     (11-08-0869P).         Paso County           County Board of
                                                            Advertiser and News.  Commissioners, 27 East
                                                                                Vermijo Avenue, Colorado
                                                                                Springs, CO 80903.
    Routt (FEMA Docket No.: B-      Town of Hayden (11-08- Nov. 6, 2011, Nov.    The Honorable Jim          Mar. 12, 2012..................       080157
     1244).                          0603P).                13, 2011, The         Haskins, Mayor, Town of
                                                            Steamboat Pilot &     Hayden, 178 West
                                                            Today.                Jefferson Avenue,
                                                                                Hayden, CO 81639.
    Weld (FEMA Docket No.: B-1244)  City of Fort Lupton    Nov. 9, 2011, Nov.    The Honorable Tommy        Mar. 15, 2012..................       080183
                                     (11-08-0714P).         16, 2011, The         Holton, Mayor, City of
                                                            Greeley Tribune.      Fort Lupton, 130 South
                                                                                McKinley Avenue, Fort
                                                                                Lupton, CO 80621.
    Weld (FEMA Docket No.: B-1244)  Unincorporated areas   Nov. 9, 2011, Nov.    The Honorable Douglas      Mar. 15, 2012..................       080266
                                     of Weld County (11-    16, 2011, The         Rademacher, Chairman,
                                     08-0714P).             Greeley Tribune.      Weld County Board of
                                                                                Commissioners, 1150 O
                                                                                Street, Greeley, CO
                                                                                80631.
Florida:
    Escambia (FEMA Docket No.: B-   Unincorporated areas   Nov. 25, 2011, Dec.   The Honorable Wilson       Nov. 17, 2011..................       120080
     1240).                          of Escambia County     2, 2011, The          Robertson, Chairman,
                                     (11-04-7674P).         Pensacola News        Escambia County Board of
                                                            Journal.              Commissioners, 221
                                                                                Palafox Place, Suite
                                                                                400, Pensacola, FL 32502.
    Indian River (FEMA Docket No.:  Town of Indian River   Nov. 25, 2011, Dec.   The Honorable Thomas W.    Nov. 17, 2011..................       120121
     B-1240).                        Shores (11-04-7942P).  2, 2011, The Indian   Cadden, Mayor, Town of
                                                            River Press Journal.  Indian River Shores,
                                                                                6001 North Highway A1A,
                                                                                Indian River Shores, FL
                                                                                32963.
    Lee (FEMA Docket No.: B-1240).  Unincorporated areas   Nov. 25, 2011, Dec.   The Honorable John         Nov. 17, 2011..................       125124
                                     of Lee County (12-04-  2, 2011, The News-    Manning, Chairman, Lee
                                     0044P).                Press.                County Board of
                                                                                Commissioners, 2120 Main
                                                                                Street, Fort Myers, FL
                                                                                33901.
    Lee (FEMA Docket No.: B-1244).  Unincorporated areas   Dec. 7, 2011, Dec.    The Honorable John         Nov. 29, 2011..................       125124
                                     of Lee County (12-04-  14, 2011, The News-   Manning, Chairman, Lee
                                     0347P).                Press.                County Board of
                                                                                Commissioners, 2120 Main
                                                                                Street, Fort Myers, FL
                                                                                33901.
    Orange (FEMA Docket No.: B-     City of Orlando (11-   Nov. 22, 2011, Nov.   The Honorable Buddy Dyer,  Mar. 28, 2012..................       120186
     1240).                          04-7338P).             29, 2011, The         Mayor, City of Orlando,
                                                            Orlando Sentinel.     400 South Orange Avenue,
                                                                                Orlando, FL 32802.
    Orange (FEMA Docket No.: B-     City of Orlando (11-   Dec. 5, 2011, Dec.    The Honorable Buddy Dyer,  Nov. 22, 2011..................       120186
     1244).                          04-8600P).             12, 2011, The         Mayor, City of Orlando,
                                                            Orlando Sentinel.     400 South Orange Avenue,
                                                                                Orlando, FL 32802.
Hawaii:
    Hawaii (FEMA Docket No.: B-     City and County of     Nov. 10, 2011, Nov.   The Honorable Peter B.     Mar. 16, 2012..................       150001
     1240).                          Honolulu (11-09-       17, 2011, The         Carlisle, Mayor, City
                                     3899P).                Honolulu Star-        and County of Honolulu,
                                                            Advertiser.           530 South King Street,
                                                                                Room 300, Honolulu, HI
                                                                                96813.
Mississippi:
    DeSoto (FEMA Docket No.: B-     City of Olive Branch   Oct. 27, 2011, Nov.   The Honorable Sam Rikard,  Mar. 2, 2012...................       280286
     1235).                          (11-04-4496P).         3, 2011, The DeSoto   Mayor, City of Olive
                                                            Times-Tribune.        Branch, 9200 Pigeon
                                                                                Roost Road, Olive
                                                                                Branch, MS 38654.
    Lee (FEMA Docket No.: B-1240).  City of Saltillo (10-  Nov. 4, 2011, Nov.    The Honorable Bill         Mar. 12, 2012..................       280261
                                     04-8523P).             11, 2011, The         Williams, Mayor, City of
                                                            Northeast             Saltillo, 395 Mobile
                                                            Mississippi Daily     Street, Saltillo, MS
                                                            Journal.              38866.
    Lee (FEMA Docket No.: B-1240).  Unincorporated areas   Nov. 4, 2011, Nov.    The Honorable Joe          Mar. 12, 2012..................       280227
                                     of Lee County (10-04-  11, 2011, The         McKinney, Chairman, Lee
                                     8523P).                Northeast             County Board of
                                                            Mississippi Daily     Supervisors, 200 West
                                                            Journal.              Jefferson Street, Suite
                                                                                100, Tupelo, MS 38801.
New Mexico:
    Chaves (FEMA Docket No.: B-     City of Roswell (11-   Nov. 17, 2011, Nov.   The Honorable Del Jurney,  Mar. 23, 2012..................       350006
     1244).                          06-0142P).             24, 2011, The         Mayor, City of Roswell,
                                                            Roswell Daily         425 North Richardson
                                                            Record.               Avenue, Roswell, NM
                                                                                88202.
    Chaves (FEMA Docket No.: B-     Unincorporated areas   Nov. 17, 2011, Nov.   The Honorable Stanton L.   Mar. 23, 2012..................       350125
     1244).                          of Chaves County (11-  24, 2011, The         Riggs, Chaves County
                                     06-0142P).             Roswell Daily         Manager, 1 Saint Mary's
                                                            Record.               Place, Roswell, NM 88203.
    Santa Fe (FEMA Docket No.: B-   Unincorporated areas   Nov. 29, 2011, Dec.   The Honorable Virginia     Nov. 23, 2011..................       350069
     1244).                          of Santa Fe County     6, 2011, The Santa    Vigil, Chairman, Santa
                                     (11-06-0697P).         Fe New Mexican.       Fe County Commissioners,
                                                                                102 Grant Avenue, Santa
                                                                                Fe, NM 87501.
New York:
    Dutchess (FEMA Docket No.: B-   Town of Dover (12-02-  Nov. 23, 2011, Nov.   The Honorable Ryan         May 3, 2012....................       361335
     1244).                          0166P).                30, 2011, The         Courtien, Supervisor,
                                                            Poughkeepsie          Town of Dover, 126 East
                                                            Journal.              Duncan Hill Road, Dover
                                                                                Plains, NY 12522.
North Carolina:
    Stanly (FEMA Docket No.: B-     City of Albemarle (11- Nov. 3, 2011, Nov.    The Honorable Elbert L.    Mar. 9, 2012...................       370223
     1244).                          04-3287P).             10, 2011, The         Whitley, Jr., Mayor,
                                                            Stanly News & Press.  City of Albemarle, 144
                                                                                North 2nd Street,
                                                                                Albemarle, NC 28001.
    Stanly (FEMA Docket No.: B-     Unincorporated areas   Nov. 3, 2011, Nov.    Mr. Andy Lucas, Stanly     Mar. 9, 2012...................       370361
     1244).                          of Stanly County (11-  10, 2011, The         County Manager, 1000
                                     04-3287P).             Stanly News & Press.  North 1st Street, Suite
                                                                                10, Albemarle, NC 28001.
Texas:

    Denton (FEMA Docket No.: B-     City of Denton (11-06- Nov. 17, 2011, Nov.   The Honorable Mark A.      Nov. 10, 2011..................       480194
     1244).                          3838P).                24, 2011, The         Burroughs, Mayor, City
                                                            Denton Record-        of Denton, 215 East
                                                            Chronicle.            McKinney Street, Denton,
                                                                                TX 76201.
    Tarrant (FEMA Docket No.: B-    City of Southlake (11- Nov. 10, 2011, Nov.   The Honorable John         Mar. 16, 2012..................       480612
     1244).                          06-2709P).             17, 2011, The Fort    Terrell, Mayor, City of
                                                            Worth Star-Telegram.  Southlake, 1400 Main
                                                                                Street, Suite 270,
                                                                                Southlake, TX 76092.
Virginia:
    Loudoun (FEMA Docket No.: B-    Unincorporated areas   Nov. 30, 2011, Dec.   The Honorable Scott K.     Apr. 5, 2012...................       510090
     1244).                          of Loudoun County      7, 2011, The          York, Chairman, Loudoun
                                     (11-03-0738P).         Loudoun Times         County Board of
                                                            Mirror.               Supervisors, 1 Harrison
                                                                                Street, Leesburg, VA
                                                                                20175.
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(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: July 12, 2012.
Sandra K. Knight,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2012-18494 Filed 7-27-12; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 86, Number 216 (Friday, November 12, 2021)]
[Notices]
[Pages 62886-62887]
[FR Doc No: 2021-24904]

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UNIFIED CARRIER REGISTRATION PLAN

Sunshine Act; Meeting

TIME AND DATE: November 10, 2021, 12:00 p.m. to 2:00 p.m., Eastern
time.

PLACE: This meeting will be accessible via conference call and via Zoom
Meeting and Screenshare. Any interested person may call (i) 1-929-205-
6099 (U.S. Toll) or 1-669-900-6833 (U.S. Toll) or (ii) 1-877-853-5247
(U.S. Toll Free) or 1-888-788-0099 (U.S. Toll Free), Meeting ID: 993
7383 0700, to listen and participate in this meeting. The website to
participate via Zoom Meeting and Screenshare is https://kellen.zoom.us/j/99373830700.

STATUS: This meeting will be open to the public.

MATTERS TO BE CONSIDERED: The Unified Carrier Registration Plan Finance
Subcommittee (the ``Subcommittee'') will continue its work in
developing and implementing the Unified Carrier Registration Plan and
Agreement. The subject matter of this meeting will include:

Proposed Agenda

I. Call to Order--Subcommittee Chair

    The Subcommittee Chair will welcome attendees, call the meeting to
order, call roll for the Subcommittee, confirm whether a quorum is
present, and facilitate self-introductions.

II. Verification of Publication of Meeting Notice--UCR Executive
Director

    The UCR Executive Director will verify the publication of the
meeting notice on the UCR website and distribution to the UCR contact
list via email followed by the subsequent publication of the notice in
the Federal Register.

III. Review and Approval of Subcommittee Agenda and Setting of Ground
Rules--Subcommittee Chair

For Discussion and Possible Subcommittee Action

    The Agenda will be reviewed, and the Subcommittee will consider
adoption.
Ground Rules
    [rtarr8] Subcommittee action only to be taken in designated areas
on agenda.

IV. Review and Approval of Subcommittee Minutes From the July 15, 2021
Meeting--Subcommittee Chair

For Discussion and Possible Subcommittee Action

    Draft minutes from the July 15, 2021 Subcommittee meeting via
teleconference will be reviewed. The Subcommittee will consider action
to approve.

V. Review of 2022 Administrative Budget--UCR Depository Manager

For Discussion and Possible Subcommittee Action

    The UCR Depository Manager will lead a discussion regarding the
continued preparation of the 2022 UCR administrative budget. The
Subcommittee may take action to recommend to the Board adoption of the
2022 budget.

VI. Investing Excess Fees for the 2021 Registration Year in
Certificates of Deposit (CDs)--Subcommittee Chair and UCR Depository
Manager

For Discussion and Possible Subcommittee Action

    The Subcommittee Chair and UCR Depository Manager will lead a
discussion regarding an opportunity to invest 2021 excess fees into one
or more CDs. CDs will earn a somewhat better return than the current
savings accounts at the Bank of North Dakota where these funds are
deposited. The 2021 excess fees will not be utilized until January 2023
at the earliest, so earning a higher rate of return will increase the
excess fees, providing for additional funding in 2023. The Subcommittee
may take action to recommend a plan to the Board.

VII. Development of an Investment Strategy--Subcommittee Chair and UCR
Depository Manager

For Discussion and Possible Subcommittee Action

    The Subcommittee Chair and UCR Depository Manager will lead a
discussion regarding the development of an investment strategy and
policy for increasing the rate of return on administrative reserve
funds that are currently invested in CDs, which are earning
historically low rates of interest. Maintaining safety of
administrative reserves capital will be a priority in the strategy. The
Subcommittee may take action to recommend a plan to the Board for
investing administrative reserve funds.

VIII. Review of 2021 Administrative Expenses--UCR Depository Manager

    The UCR Depository Manager will review the expenditures of the UCR
Plan for the first ten months ended October 31, 2021 with the
Subcommittee. A forecast for the final two months in the year will also
be presented.

IX. Other Business--Subcommittee Chair

    The Subcommittee Chair will call for any other items Subcommittee
members would like to discuss.

X. Adjournment--Subcommittee Chair

    The Subcommittee Chair will adjourn the meeting.
    The agenda will be available no later than 5:00 p.m. Eastern time,
November 3, 2021 at: https://plan.ucr.gov.

CONTACT PERSON FOR MORE INFORMATION: Elizabeth Leaman, Chair, Unified
Carrier Registration Plan Board of Directors,<PHONE_NUMBER>,
[email protected].

Alex B. Leath,
Chief Legal Officer, Unified Carrier Registration Plan.
[FR Doc. 2021-24904 Filed 11-9-21; 4:15 pm]
BILLING CODE 4910-YL-P


[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Rules and Regulations]
[Pages 53309-53313]
[FR Doc No: 2019-21514]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 526, 529, 556, and 558

[Docket No. FDA-2019-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor's Name and Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during April, May, and June 2019. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to make technical
amendments to improve the accuracy of the regulations.

DATES: This rule is effective October 7, 2019.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (CVM) (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during April, May, and June 2019, as
listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
office of the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday. Persons with access
to the internet may obtain these documents at the CVM FOIA Electronic
Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                              Table 1--Original and Supplemental NADAs and ANADAs Approved During April, May, and June 2019
--------------------------------------------------------------------------------------------------------------------------------------------------------
     Approval date        File No.          Sponsor            Product name             Species            Effect of the action       Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 11, 2019........      140-989  Syndel USA, 1441 W.   PARASITE-S            Freshwater-reared      Supplemental approval for  FOI Summary.
                                      Smith Rd.,            (formalin) Aqueous    finfish.               the control of mortality
                                      Ferndale, WA 98248.   Formaldehyde                                 in freshwater-reared
                                                            Solution.                                    finfish due to
                                                                                saprolegniasis
                                                                                associated with fungi in
                                                                                the family
                                                                                Saprolegniaceae.
May 6, 2019...........      141-288  Zoetis Inc., 333      EXCENEL RTU EZ        Cattle and swine.....  Supplemental approval      FOI Summary.
                                      Portage St.,          (ceftiofur                                   providing for an
                                      Kalamazoo, MI 49007.  hydrochloride)                               increase in the maximum
                                                            Sterile Suspension.                          injection site volume in
                                                                                swine.
May 7, 2019...........      200-633  Pharmgate LLC, 1800   DERACIN               Swine................  Original approval as a     FOI Summary.
                                      Sir Tyler Dr.,        (chlortetracycline)                          generic copy of NADA 141-
                                      Wilmington, NC        plus DENAGARD                                011.
                                      28405.                (tiamulin hydrogen
                                                            fumarate) Type C
                                                            medicated swine
                                                            feeds.
May 16, 2019..........      200-598  Bimeda Animal Health  ENROMED 100           Cattle and swine.....  Original approval as a     FOI Summary.
                                      Ltd., 1B The          (enrofloxacin)                               generic copy of NADA 141-
                                      Herbert Building,     Antimicrobial                                068.
                                      The Park,             Injectable Solution.
                                      Carrickmines,
                                      Dublin, 18, Ireland.
May 21, 2019..........      141-512  Elanco US Inc. 2500   EXPERIOR              Cattle...............  Original approval for      FOI Summary.
                                      Innovation Way,       (lubabegron),                                beef steers and heifers
                                      Greenfield, IN        RUMENSIN                                     fed in confinement for
                                      46140.                (monensin), and                              slaughter during the
                                                            TYLAN (tylosin                               last 14 to 91 days on
                                                            phosphate) Type C                            feed for reduction of
                                                            medicated feeds.                             ammonia gas emissions
                                                                                per pound of live weight
                                                                                and hot carcass weight;
                                                                                for reduction of
                                                                                incidence of liver
                                                                                abscesses associated
                                                                                with Fusobacterium
                                                                                necrophorum and
                                                                                Arcanobacterium
                                                                                pyogenes; and for either
                                                                                improved feed efficiency
                                                                                or prevention and
                                                                                control of coccidiosis
                                                                                due to Eimeria bovis and
                                                                                E. zuernii.
May 21, 2019..........      141-514  Elanco US Inc. 2500   EXPERIOR              Cattle...............  Original approval for      FOI Summary.
                                      Innovation Way,       (lubabegron) and                             beef steers and heifers
                                      Greenfield, IN        RUMENSIN (monensin)                          fed in confinement for
                                      46140.                Type C medicated                             slaughter during the
                                                            feeds.                                       last 14 to 91 days on
                                                                                feed for reduction of
                                                                                ammonia gas emissions
                                                                                per pound of live weight
                                                                                and hot carcass weight;
                                                                                and for either improved
                                                                                feed efficiency or
                                                                                prevention and control
                                                                                of coccidiosis due to
                                                                                Eimeria bovis and E.
                                                                                zuernii.
May 30, 2019..........      200-573  Bimeda Animal Health  OXYMED LA             Cattle and swine.....  Original approval as a     FOI Summary.
                                      Ltd., 1B The          (oxytetracycline                             generic copy of NADA 113-
                                      Herbert Building,     injection).                                  232.
                                      The Park,
                                      Carrickmines,
                                      Dublin, 18, Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Change of Sponsor's Names and Addresses

    Medicis Dermatologics, Inc., 8125 North Hayden Rd., Scottsdale, AZ
85258 has informed FDA that it has changed its name and address to
Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ
08807. Accordingly, we are amending Sec.  510.600(c) to reflect these
changes.

III. Technical Amendments

    A section describing tolerances of hetacillin residues (21 CFR
556.316) has been added to subpart B of part 556. This section cross-
references the sole hetacillin product approved for use in food-
producing animals, an intramammary infusion for use in lactating dairy
cows (21 CFR 526.1130). This new section codifies FDA's finding at the
time of product approval that, because hetacillin is rapidly hydrolyzed
to ampicillin, existing ampicillin tolerances provide appropriate
tolerances for hetacillin in edible tissues of cattle (38 FR 31172,
November 12, 1973). This amendment is being made to make the
regulations more comprehensive.
    FDA is also revising the regulations to reflect the approved
conditions of use of sulfaquinoxaline soluble powder as a veterinary
prescription product for oral administration to cattle as a drench.
Finally, we are also revising the regulations for use of monensin in
medicated goat feed to reflect the approved incorporation level. These
actions are being taken to improve the accuracy of the regulations.

IV. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(i)), which
requires Federal Register publication of ``notice[s] . . . effective as
a regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 526, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 520, 522, 526, 529, 556, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry
for ``Medicis Dermatologics, Inc.'' and add an entry in alphabetic
order for ``Bausch Health US, LLC''; and in the table in paragraph
(c)(2), revise the entry for ``099207''.
    The addition and revision read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------

                              * * * * * * *
Bausch Health US, LLC, 400 Somerset Corporate Blvd.,              099207
 Bridgewater, NJ 08807..................................

                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------

                              * * * * * * *
099207.......................  Bausch Health US, LLC, 400 Somerset
                                Corporate Blvd., Bridgewater, NJ 08807.
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for part 520 continues to read as follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.812  [Amended]

0
4. In Sec.  520.812, in paragraph (a)(1)(i), remove ``2.7'' and in its
place add ``22.7''.

0
5. In Sec.  520.2325b, revise paragraph (d)(3) to read as follows:

Sec.  520.2325b  Sulfaquinoxaline drench.

* * * * *
    (d) * * *
    (3) Limitations. Not for use in lactating dairy cattle. A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.

Federal law restricts this drug to use by or on the order of a licensed
veterinarian.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
6. The authority citation for part 522 continues to read as follows:

    Authority: 21 U.S.C. 360b.

0
7. In Sec.  522.313b, revise paragraphs (a)(2) and (e)(1)(iii) to read
as follows:

Sec.  522.313b  Ceftiofur hydrochloride.

    (a) * * *
    (2) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur
equivalents in the inactive vehicles polyoxyethylene sorbitan
monooleate (polysorbate 80) in a caprylic/capric triglyceride
suspension; or
* * * * *
    (e) * * *
    (1) * * *
    (iii) Limitations. For products described in paragraphs (a)(1) and
(3) of this section: Treated swine must not be slaughtered for 4 days
following the last treatment. For products described in paragraph
(a)(2) of this section: Treated swine must not be slaughtered for 6
days following the last treatment when injection site volumes are
greater than 5 mL up to the maximum injection site volume of 15 mL.
Treated swine must not be slaughtered for 4 days when injection site
volumes are less than or equal to 5 mL.
* * * * *

0
8. In Sec.  522.812, revise paragraphs (b)(1) and (2) to read as
follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (b) * * *
    (1) Nos. 000859, 026637, and 055529 for use of product described in
paragraph (a)(1) as in paragraph (e)(1); and
    (2) Nos. 000859, 055529, and 061133 for use of product described in
paragraph (a)(2) as in paragraphs (e)(2) and (3) of this section.
* * * * *

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
9. The authority citation for part 526 continues to read as follows:

    Authority: 21 U.S.C. 360b.

0
10. In Sec.  526.1130, revise the section heading, redesignate
paragraph (c) as paragraph (d), and add new paragraph (c).
    The revision and addition read as follows:

Sec.  526.1130  Hetacillin.

* * * * *
    (c) Related tolerances. See Sec.  556.316 of this chapter.
* * * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
11. The authority citation for part 529 continues to read as follows:

    Authority: 21 U.S.C. 360b.

0
12. In Sec.  529.1030, revise paragraph (b) and add paragraphs
(d)(1)(iv) and (d)(2)(iv) to read as follows:

Sec.  529.1030  Formalin.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for
uses as in paragraph (d) of this section.
    (1) No. 050378 for use as in paragraph (d) of this section.
    (2) Nos. 049968 and 067188 for use as in paragraphs (d)(1)(i),
(ii), and (iii), (d)(2)(i), (ii), and (iii), and (d)(3) of this
section.
    (d) * * *
    (1) * * *
    (iv) Freshwater-reared finfish. For the control of mortality due to
saprolegniasis associated with fungi in the family Saprolegniaceae.
    (2) * * *
    (iv) For the control of mortality in freshwater-reared finfish due
to saprolegniasis associated with fungi in the family Saprolegniaceae:
In tanks and raceways, administer 150 [mu]L/L (ppm) for 60 minutes per
day on alternate days for three treatments.
* * * * *

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
13. The authority citation for part 556 continues to read as follows:

    Authority: 21 U.S.C. 342, 360b, 371.

0
14. Add Sec.  556.316 to read as follows:

Sec.  556.316  Hetacillin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for ampicillin (marker residue for
hetacillin) are:
    (1) Cattle. Edible tissues: 0.01 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  526.1130 of this chapter.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
15. The authority citation for part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
16. In Sec.  558.4, in paragraph (d), in the ``Category II'' table,
revise the row entry for ``Tilmicosin'' to read as follows:

Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                       Assay limits
                Drug                    percent \1\       Type B maximum (100x)       Assay limits percent \1\
                                          Type A                                            Type B/C \2\
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Tilmicosin..........................          90-110  37.9 g/lb (8.35%)...........  Swine Type B/C feed: 85-115
                                                                                Cattle Type B feed: 85-115
                                                                                Cattle Type C feed: 80-110

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
17. In Sec.  558.330, revise paragraph (d) to read as follows:

Sec.  558.330  Lubabegron.

* * * * *
    (d) Conditions of use--(1) It is used in cattle feed as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Combination in grams/
  Lubabegron fumarate in grams/ton             ton               Indications for use                        Limitations                       Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 1.25 to 4.54...................  ......................  Beef steers and heifers fed  Feed continuously as the sole ration to                 058198
                                                              in confinement for           provide 13 to 90 mg lubabegron/head/day
                                                              slaughter: For reduction     during the last 14 to 91 days on feed. A
                                                              of ammonia gas emissions     decrease in dry matter intake may be noticed
                                                              per pound of live weight     in some animals receiving lubabegron. Not
                                                              and hot carcass weight       approved for use in breeding animals because
                                                              during the last 14 to 91     safety and effectiveness have not been
                                                              days on feed.                evaluated in these animals. Do not allow
                                                                                horses or other equines access to feed
                                                                                containing lubabegron.
(ii) 1.25 to 4.54..................  Monensin, 5 to 40.....  Beef steers and heifers fed  Feed continuously as the sole ration to                 058198
                                                              in confinement for           provide 13 to 90 mg lubabegron/head/day and
                                                              slaughter: For reduction     50 to 480 mg monensin/head/day during the
                                                              of ammonia gas emissions     last 14 to 91 days on feed. No additional
                                                              per pound of live weight     improvement in feed efficiency has been shown
                                                              and hot carcass weight and   from feeding monensin at levels greater than
                                                              for improved feed            30 g/ton (360 mg monensin/head/day. A
                                                              efficiency during the last   decrease in dry matter intake may be noticed
                                                              14 to 91 days on feed.       in some animals receiving lubabegron.
                                                                                Lubabegron has not been approved for use in
                                                                                breeding animals because safety and
                                                                                effectiveness have not been evaluated in
                                                                                these animals. Do not allow horses or other
                                                                                equines access to feed containing lubabegron
                                                                                and monensin. Ingestion of monensin by horses
                                                                                has been fatal. Monensin medicated cattle and
                                                                                goat feeds are safe for use in cattle and
                                                                                goats only. Consumption by unapproved species
                                                                                may result in toxic reactions. Feeding
                                                                                undiluted or mixing errors resulting in high
                                                                                concentrations of monensin has been fatal to
                                                                                cattle and could be fatal to goats. Must be
                                                                                thoroughly mixed in feeds before use. Do not
                                                                                exceed the levels of monensin recommended in
                                                                                the feeding directions, as reduced average
                                                                                daily gains may result. If feed refusals
                                                                                containing monensin are fed to other groups
                                                                                of cattle, the concentration of monensin in
                                                                                the refusals and amount of refusals fed
                                                                                should be taken into consideration to prevent
                                                                                monensin overdosing. A withdrawal period has
                                                                                not been established for this product for
                                                                                preruminating calves. Do not use in calves to
                                                                                be processed for veal.
(iii) 1.25 to 4.54.................  Monensin, 10 to 40....  Beef steers and heifers fed  Feed continuously as the sole ration to                 058198
                                                              in confinement for           provide 13 to 90 mg lubabegron/head/day and
                                                              slaughter: For reduction     0.14 to 0.42 mg monensin/lb body weight per
                                                              of ammonia gas emissions     day, depending upon severity of coccidiosis
                                                              per pound of live weight     challenge, during the last 14 to 91 days on
                                                              and hot carcass weight;      feed. A decrease in dry matter intake may be
                                                              and for prevention and       noticed in some animals receiving lubabegron.
                                                              control of coccidiosis due   Lubabegron has not been approved for use in
                                                              to Eimeria bovis and E.      breeding animals because safety and
                                                              zuernii during the last 14   effectiveness have not been evaluated in
                                                              to 91 days on feed.          these animals. Do not allow horses or other
                                                                                equines access to feed containing lubabegron
                                                                                and monensin. Ingestion of monensin by horses
                                                                                has been fatal. Monensin medicated cattle and
                                                                                goat feeds are safe for use in cattle and
                                                                                goats only. Consumption by unapproved species
                                                                                may result in toxic reactions. Feeding
                                                                                undiluted or mixing errors resulting in high
                                                                                concentrations of monensin has been fatal to
                                                                                cattle and could be fatal to goats. Must be
                                                                                thoroughly mixed in feeds before use. Do not
                                                                                exceed the levels of monensin recommended in
                                                                                the feeding directions, as reduced average
                                                                                daily gains may result. If feed refusals
                                                                                containing monensin are fed to other groups
                                                                                of cattle, the concentration of monensin in
                                                                                the refusals and amount of refusals fed
                                                                                should be taken into consideration to prevent
                                                                                monensin overdosing. A withdrawal period has
                                                                                not been established for this product for
                                                                                preruminating calves. Do not use in calves to
                                                                                be processed for veal.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (2) Lubabegron may also be used in combination with:
    (i) Tylosin as in Sec.  558.625.
    (ii) [Reserved]

0
18. In Sec.  558.355, in paragraph (f)(6)(i), in the ``Monensin in
grams/ton'' column, remove ``5 to 40'' and in its place add ``20''; and
redesignate paragraphs (f)(7)(iv) through (xi) as paragraphs (f)(7)(v)
through (xii) and add new paragraph (f)(7)(iv).
    The addition reads as follows:

Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (7) * * *
    (iv) Lubabegron as in Sec.  558.330.
* * * * *

0
19. In Sec.  558.625, redesignate paragraphs (e)(2)(vii) through (xv)
as paragraphs (e)(2)(ix) through (xvii), and add new paragraphs
(e)(2)(vii) and (viii).
    The additions read as follows:

Sec.  558.625  Tylosin.

* * * * *
    (e) * * *
    (2) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Combination in grams/
         Tylosin grams/ton                     ton               Indications for use                        Limitations                       Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
(vii) 8 to 10......................  Monensin, 5 to 40 plus  Beef steers and heifers fed  Feed continuously as sole ration to provide 13          058198
                                      lubabegron fumarate,    in confinement for           to 90 mg lubabegron/head/day, 50 to 480 mg
                                      1.25 to 4.54.           slaughter: For reduction     monensin/head/day, and 60 to 90 mg tylosin/
                                                              of ammonia gas emissions     head/day during the last 14 to 91 days on
                                                              per pound of live weight     feed. No additional improvement in feed
                                                              and hot carcass weight;      efficiency has been shown from feeding
                                                              for reduction of incidence   monensin at levels greater than 30 g/ton (360
                                                              of liver abscesses           mg monensin/head/day. A decrease in dry
                                                              associated with              matter intake may be noticed in some animals
                                                              Fusobacterium necrophorum    receiving lubabegron. Lubabegron has not been
                                                              and Arcanobacterium          approved for use in breeding animals because
                                                              pyogenes, and for improved   safety and effectiveness have not been
                                                              feed efficiency during the   evaluated in these animals. Do not allow
                                                              last 14 to 91 days on feed.  horses or other equines access to feed
                                                                                containing lubabegron and monensin. Ingestion
                                                                                of monensin by horses has been fatal.
                                                                                Monensin medicated cattle and goat feeds are
                                                                                safe for use in cattle and goats only.
                                                                                Consumption by unapproved species may result
                                                                                in toxic reactions. Feeding undiluted or
                                                                                mixing errors resulting in high
                                                                                concentrations of monensin has been fatal to
                                                                                cattle and could be fatal to goats. Must be
                                                                                thoroughly mixed in feeds before use. Do not
                                                                                exceed the levels of monensin recommended in
                                                                                the feeding directions, as reduced average
                                                                                daily gains may result. If feed refusals
                                                                                containing monensin are fed to other groups
                                                                                of cattle, the concentration of monensin in
                                                                                the refusals and amount of refusals fed
                                                                                should be taken into consideration to prevent
                                                                                monensin overdosing. A withdrawal period has
                                                                                not been established for this product for
                                                                                preruminating calves. Do not use in calves to
                                                                                be processed for veal.
(viii) 8 to 10.....................  Monensin, 10 to 40      Beef steers and heifers fed  Feed continuously as sole ration to provide 13          058198
                                      plus lubabegron         in confinement for           to 90 mg lubabegron/head/day, 0.14 to 0.42 mg
                                      fumarate, 1.25 to       slaughter: For reduction     monensin/lb body weight per day, depending
                                      4.54.                   of ammonia gas emissions     upon severity of coccidiosis challenge, up to
                                                              per pound of live weight     480 mg/head/day, and 60 to 90 mg tylosin/head/
                                                              and hot carcass weight,      day during the last 14 to 91 days on feed. A
                                                              for reduction of incidence   decrease in dry matter intake may be noticed
                                                              of liver abscesses           in some animals receiving lubabegron.
                                                              associated with              Lubabegron has not been approved for use in
                                                              Fusobacterium necrophorum    breeding animals because safety and
                                                              and Arcanobacterium          effectiveness have not been evaluated in
                                                              pyogenes, and for            these animals. Do not allow horses or other
                                                              prevention and control of    equines access to feed containing lubabegron
                                                              coccidiosis due to Eimeria   and monensin. Ingestion of monensin by horses
                                                              bovis and E. zuernii         has been fatal. Monensin medicated cattle and
                                                              during the last 14 to 91     goat feeds are safe for use in cattle and
                                                              days on feed.                goats only. Consumption by unapproved species
                                                                                may result in toxic reactions. Feeding
                                                                                undiluted or mixing errors resulting in high
                                                                                concentrations of monensin has been fatal to
                                                                                cattle and could be fatal to goats. Must be
                                                                                thoroughly mixed in feeds before use. Do not
                                                                                exceed the levels of monensin recommended in
                                                                                the feeding directions, as reduced average
                                                                                daily gains may result. If feed refusals
                                                                                containing monensin are fed to other groups
                                                                                of cattle, the concentration of monensin in
                                                                                the refusals and amount of refusals fed
                                                                                should be taken into consideration to prevent
                                                                                monensin overdosing. A withdrawal period has
                                                                                not been established for this product for
                                                                                preruminating calves. Do not use in calves to
                                                                                be processed for veal.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Dated: September 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21514 Filed 10-4-19; 8:45 am]
 BILLING CODE 4164-01-P