[Federal Register Volume 84, Number 154 (Friday, August 9, 2019)]
[Rules and Regulations]
[Pages 39179-39187]
[FR Doc No: 2019-16884]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 558

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

New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Changes of
Sponsorship; Change of Sponsors' Names and Addresses

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 January, February, and March 2019. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable.
Technical amendments are also being made to improve the accuracy,
consistency, and readability of the regulations.

DATES: This rule is effective August 9, 2019, except for amendatory
instructions 51 to 21 CFR 524.916 and 63 to 21 CFR 558.325, which are
effective August 19, 2019, and instruction 60 to 21 CFR 558.235, which
is effective September 9, 2019.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (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 January, February, and March 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 January, February, and March 2019
--------------------------------------------------------------------------------------------------------------------------------------------------------
           Approval date              File No.        Sponsor        Product name           Species          Effect of the action     Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 27, 2019..................      009-476  Phibro Animal     NICARB 25%        Chickens.............  Supplemental approval  N/A.
                                                  Health Corp.,     (nicarbazin)                             of revised assay
                                                  GlenPointe        Type A                                   limits for
                                                  Centre East, 3d   medicated                                nicarbazin (powder)
                                                  Floor, 300        article.                                 Type A medicated
                                                  Frank W. Burr                                              article.
                                                  Blvd., Suite
                                                  21, Teaneck, NJ
                                                  07666.
January 28, 2019..................      200-616  Norbrook          CEFENIL RTU       Swine and cattle.....  Original approval as   FOI Summary.
                                                  Laboratories,     (ceftiofur                               a generic copy of
                                                  Ltd., Station     hydrochloride                            NADA 140-890.
                                                  Works, Newry      sterile
                                                  BT35 6JP,         suspension).
                                                  Northern
                                                  Ireland.
January 31, 2019..................      200-450  Bimeda Animal     BIMECTIN PLUS     Cattle...............  Original approval as   FOI Summary.
                                                  Health Ltd., 1B   (ivermectin/                             a generic copy of
                                                  The Herbert       clorsulon)                               NADA 140-833.
                                                  Building, The     Injection for
                                                  Park,             Cattle.
                                                  Carrickmines,
                                                  Dublin, 18,
                                                  Ireland.
February 4, 2019..................      200-637  Provetica AH      DOXIDYL           Dogs.................  Original approval as   FOI Summary.
                                                  LLC, 455          (deracoxib)                              a generic copy of
                                                  Sovereign Ct.,    Chewable Tablet.                         NADA 141-203.
                                                  Baldwin, MO
                                                  63011.
February 8, 2019..................      141-297  Boehringer        PROZINC           Dogs.................  Supplemental approval  FOI Summary.
                                                  Ingelheim         (protamine zinc                          for the reduction of
                                                  Vetmedica,        recombinant                              hyperglycemia and
                                                  Inc., 2621        human insulin)                           hyperglycemia-
                                                  North Belt        Injectable                               associated clinical
                                                  Highway, St.      Suspension.                              signs in dogs with
                                                  Joseph, MO                                                 diabetes mellitus.
                                                  64506-2002.

March 29, 2019....................      048-761  Zoetis Inc., 333  AUREOMYCIN        Cattle...............  Supplemental approval  N/A.
                                                  Portage St.,      (chlortetracycl                          adding replacement
                                                  Kalamazoo, MI     ine) Type C                              dairy heifers to the
                                                  49007.            medicated feeds.                         indications for use
                                                                                of chlortetracycline
                                                                                Type C medicated
                                                                                cattle feeds for
                                                                                control of bacterial
                                                                                pneumonia associated
                                                                                with shipping fever
                                                                                complex caused by
                                                                                Pasteurella spp.
                                                                                susceptible to
                                                                                chlortetracycline.
March 29, 2019....................      141-517  Pegasus           PROIN ER          Dogs.................  Original approval for  FOI Summary.
                                                  Laboratories,     (phenylpropanol                          the control of
                                                  Inc., 8809 Ely    amine                                    urinary incontinence
                                                  Rd., Pensacola,   hydrochloride                            due to urethral
                                                  FL 32514.         extended-                                sphincter hypotonus.
                                                                    release
                                                                    tablets)
                                                                    Tablets.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Changes of Sponsors' Names and Addresses

    Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN
55057-3009 has informed FDA that it has changed its name to Aurora
Pharmaceutical, Inc.
    Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St.
Joseph, MO 64506-2002 has informed FDA that it has changed its name and
address to Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite
Blvd., Duluth, GA 30096.
    Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY
11967 has informed FDA that it has changed its name to American Regent,
Inc.
    Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405 has
informed FDA that it has changed its name to Pharmgate, Inc.
    Accordingly, we are amending Sec.  510.600(c) to reflect these
changes.

III. Changes of Sponsorship

    Provetica AH LLC, 455 Sovereign Ct., Baldwin, MO 63011 has informed
FDA that it has transferred ownership of, and all rights and interest
in, newly approved ANADA 200-637 for DOXIDYL (deracoxib) Chewable
Tablets to Ceva Sante Animale, 10 Avenue de la Ballasti[egrave]re,
33500 Libourne, France. Following this change of sponsorship, Provetica
AH LLC is no longer the sponsor of an approved application.
Accordingly, it will not be added to the list of sponsors of approved
applications in Sec.  510.600(c) (21 CFR 510.600(c)).
    Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-
4640 has informed FDA that it has transferred ownership of, and all
rights and interest in, the following applications to Boehringer
Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA
30096:

------------------------------------------------------------------------
        File No.                         Proprietary name
------------------------------------------------------------------------
006-623                   CAPARSOLATE (arsenamide sodium) Injection.
008-422                   SELEEN (selenium disulfide) Suspension.
010-424                   NALLINE (nalorphine hydrochloride) Injection.
011-080                   HYDELTRONE-TBA (prednisolone and tertiary
                           butylacetate) Suspension.
011-437                   HYDELTRONE (prednisolone sodium phosphate and
                           neomycin sulfate) Ointment.
011-532                   SULFABROM (sulfabromomethazine sodium) Bolus.
011-678                   DIURIL (chlorothiazide) Tablets.
012-734                   DIURIL (chlorothiazide) Bolus.
013-022                   THIBENZOLE (thiabendazole) Sheep & Goat
                           Wormer.
013-407                   EQUIZOLE (thiabendazole) Horse Wormer.
013-674                   HYDROZIDE (hydrochlorothiazide) Injection.
013-954                   THIBENZOLE (thiabendazole) 20% Swine Premix.
014-350                   OMNIZOLE (thiabendazole).
015-123                   TBZ[supreg] (thiabendazole) Cattle Wormer
                           (Drench).
015-875                   TBZ 200 (thiabendazole) Medicated Premix.
030-103                   THIBENZOLE (thiabendazole) Suspension.
034-114                   EQUIZOLE (thiabendazole).
035-631                   THIBENZOLE (thiabendazole) Pig Wormer.
037-410                   EQUIZOLE A (thiabendazole and piperazine
                           phosphate).
042-633                   TRESADERM (thiabendazole, dexamethasone,
                           neomycin sulfate solution) Dermatologic
                           Solution.
043-141                   THIBENZOLE 300 (thiabendazole) Medicated.
044-654                   EQUIZOLE (thiabendazole) Horse Wormer Pellets.
047-333                   EQUIZOLE A (thiabendazole and piperazine
                           citrate) Liquid.
048-487                   TBZ (thiabendazole) Wormer Paste 50%.
042-633                   TRESADERM (thiabendazole, dexamethasone,
                           neomycin sulfate solution) Dermatologic
                           Solution.
043-141                   THIBENZOLE 300 (thiabendazole) Medicated.
044-654                   EQUIZOLE (thiabendazole) Horse Wormer Pellets.
047-333                   EQUIZOLE A (thiabendazole and piperazine
                           citrate) Liquid.
048-487                   TBZ (thiabendazole) Wormer Paste 50%.
049-461                   TBZ (thiabendazole) Wormer Paste 43%.
065-275                   Penicillin VK Filmtab (penicillin V potassium)
                           250 mg.
065-276                   VEESYN (penicillin V potassium) Granules for
                           Oral Solution.
094-642                   CAMVET (cambendazole) Suspension Horse Wormer.

096-506                   CAMVET (cambendazole) Horse Wormer Pellets.
096-731                   CAMVET (cambendazole) Horse Wormer Paste 45%.
098-379                   CYSTORELIN.
098-689                   EQUIZOLE (thiabendazole) 50% Wormer Paste;
                           EQUIZOLE 50% Wormer Paste for Horses.
127-443                   EQVALAN (ivermectin) Injection.
128-409                   IVOMEC (ivermectin) .27% Injection Grower and
                           Feeder Pigs; IVOMEC (ivermectin) 1%
                           Injection; IVOMEC (ivermectin) 1% Injection
                           for Cattle and Swine; IVOMEC (ivermectin)
                           Injection for Cattle.
131-392                   IVOMEC (ivermectin) Liquid for Sheep.
134-314                   EQVALAN (ivermectin).
134-930                   SYNCRO-MATE-B (norgestomet and estradiol
                           valerate) Implant.
136-742                   CURATREM (clorsulon) Drench for Cattle.
137-006                   IVOMEC (ivermectin) Cattle Paste 0.153%.
138-412                   HEARTGARD (ivermectin) Tablets.
140-439                   EQVALAN (ivermectin) Oral Liquid for Horses.
140-818                   PRODUCIL (efrotomycin) Type A Medicated
                           Article for Swine.
140-833                   IVOMEC Plus (ivermectin and clorsulon)
                           Injection For Cattle.
140-841                   IVOMEC (ivermectin) Pour-On.
140-883                   LEGEND (hyaluronate sodium) Injectable
                           Solution.
140-886                   HEARTGARD (ivermectin) Chewables for Dogs.
140-971                   HEARTGARD Plus (ivermectin and pyrantel
                           pamoate).
140-974                   IVOMEC (ivermectin) Premix for Swine.
140-988                   IVOMEC (ivermectin) Sustained-Release Bolus
                           for Cattle.
141-015                   ENACARD (enalapril maleate) Tablets for Dogs.
141-042                   IMMITICIDE (melarsomine dihydrochloride)
                           Sterile Powder.
141-054                   IVOMEC (ivermectin) plus LINCOMIX
                           (lincomycin).
141-078                   HEARTGARD (ivermectin) for Cats.
141-079                   EPRINEX (eprinomectin) Pour-On for Beef and
                           Dairy Cattle.
141-097                   BMD (bacitracin methylendisalicylate)/IVOMEC
                           (ivermectin) Premix for Swine.
141-123                   GASTROGARD (omeprazole).
141-188                   MARQUIS (ponazuril) Antiprotozoal Oral Paste.
141-214                   ZIMECTERIN Gold (ivermectin and praziquantel)
                           Paste.
141-227                   ULCERGARD (omeprazole).
141-230                   PREVICOX (firocoxib) Chewable Tablets.
141-253                   EQUIOXX (firocoxib) Oral Paste.
141-313                   EQUIOXX (firocoxib) Injection.
141-327                   LONGRANGE (eprinomectin) Injection.
141-328                   ZACTRAN (gamithromycin) Injectable Solution.
141-406                   NEXGARD (afoxolaner) Chewable Tablet.
141-421                   DUOCARE (ivermectin and praziquantel) Paste.
141-458                   EQUIOXX (firocoxib) Tablets.
141-492                   CENTRAGARD (eprinomectin and praziquantel)
                           Solution.
200-564                   Ivermectin Paste 1.87%.
------------------------------------------------------------------------

    Following this change of sponsorship, Merial, Inc., is no longer
the sponsor of an approved application. Accordingly, it will be removed
from the list of sponsors of approved applications in Sec.  510.600(c).
As provided in the regulatory text, the animal drug regulations are
amended to reflect these changes of sponsorship.

IV. Withdrawals of Approval

    Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd.,
Duluth, GA 30096, has requested that FDA withdraw approval of newly
transferred NADA 141-054 for use of LINCOMIX (lincomycin hydrochloride)
plus IVOMEC (ivermectin) Type A medicated articles to manufacture 2-
way, combination drug Type C medicated feed for swine because the
product is no longer manufactured or marketed.
    Also, Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140,
has requested that FDA withdraw approval of NADA 141-337 for use of
RECOVYRA (fentanyl) Transdermal Solution for Dogs because the product
is no longer manufactured or marketed.
    Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADAs 141-054 and 141-337, and all supplements and
amendments thereto, is withdrawn effective August 19, 2019. As provided
in the regulatory text of this document, the animal drug regulations
are amended to reflect these actions.

V. Technical Amendments

    FDA is removing ``IDEXX Pharmaceuticals, Inc.'' from the list of
sponsors of approved applications in Sec.  510.600(c). This action is
being taken to improve the accuracy of the regulations.
    In addition, we are reformatting the regulations to present the
approved conditions of use of famphur, morantel, and thiabendazole in
tabular format in the respective named sections of subpart B of part
558. This action is being taken to improve the readability and
consistency of the regulations.

VI. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (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, and 524

    Animal drugs.

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, 524, 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:
0
a. In the table in paragraph (c)(1):
0
i. Add an entry in alphabetical order for ``American Regent, Inc.'';
0
ii. Revise the entries for ``Aurora Pharmaceutical, LLC'', ``Boehringer
Ingelheim Vetmedica, Inc.'';
0
iii. Remove the entries for ``IDEXX Pharmaceuticals, Inc.'', ``Luitpold
Pharmaceuticals, Inc.'', and ``Merial, Inc.''; and
0
iv. Revise the entry for ``Pharmgate, LLC''; and
0
b. In the table in paragraph (c)(2):
0
i. Revise the entries for ``000010'' and ``010797'';
0
ii. Remove the entry for ``050604'';
0
iii. Revise the entry for ``051072'';
0
iv. Remove the entry for ``065274''; and
0
v. Revise the entry for ``069254''.
    The additions and revisions 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
------------------------------------------------------------------------

                              * * * * * * *
American Regent, Inc., Animal Health Division, Shirley,           010797
 NY 11967...............................................

                              * * * * * * *
Aurora Pharmaceutical, Inc., 1196 Highway 3 South,                051072
 Northfield, MN 55057-3009..............................

                              * * * * * * *
Boehringer Ingelheim Animal Health USA, Inc., 3239                000010
 Satellite Blvd., Duluth, GA 30096......................

                              * * * * * * *
Pharmgate, Inc., 1800 Sir Tyler Dr., Wilmington, NC               069254
 28405..................................................

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

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------
000010..................  Boehringer Ingelheim Animal Health USA, Inc.,
                           3239 Satellite Blvd., Duluth, GA 30096.

                              * * * * * * *
010797..................  American Regent, Inc., Animal Health Division,
                           Shirley, NY 11967.

                              * * * * * * *
051072..................  Aurora Pharmaceutical, Inc., 1196 Highway 3
                           South, Northfield, MN 55057-3009.

                              * * * * * * *
069254..................  Pharmgate, Inc., 1800 Sir Tyler Dr.,
                           Wilmington, NC 28405.

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

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.  520.43   [Amended]

0
4. In Sec.  520.43, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  520.284a   [Amended]

0
5. In Sec.  520.284a, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  520.284b   [Amended]

0
6. In Sec.  520.284b, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  520.284c   [Amended]

0
7. In Sec.  520.284c, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

0
8. Revise Sec.  520.420 to read as follows:

Sec.  520.420   Chlorothiazide.

    (a) Specifications--(1) Each tablet contains 0.25 grams
chlorothiazide.
    (2) Each bolus contains 2 grams chlorothiazide.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i)--Amount. Administer 5 to 10
milligrams per pound of body weight two or three times daily.
    (ii) Indications for use. For treatment of congestive heart failure
and renal edema.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
    (2) Cows--(i)--Amount. Administer 2 grams once or twice daily for 3
or 4 days.
    (ii) Indications for use. As an aid in reduction of postparturient
udder edema.
    (iii) Limitations. Milk taken from dairy animals during treatment
and for 72 hours (six milkings) after latest treatment must not be used
for food. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.

Sec.  520.462   [Amended]

0
9. In Sec.  520.462, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  520.538   [Amended]

0
10. In Sec.  520.538, in paragraph (b), remove ``No. 058198'' and in
its place add ``Nos. 013744 and 058198''.

Sec.  520.804   [Amended]

0
11. In Sec.  520.804, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  520.928   [Amended]

0
12. In Sec.  520.928, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  520.930   [Amended]

0
13. In Sec.  520.930, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  520.1192   [Amended]

0
14. In Sec.  520.1192, in paragraph (b)(1), remove ``050604'' and in
its place add ``000010''.

Sec.  520.1193   [Amended]

0
15. In Sec.  520.1193, in paragraph (b)(1), remove ``050604'' and in
its place add ``000010''.

Sec.  520.1195   [Amended]

0
16. In Sec.  520.1195, in paragraph (b)(1), remove ``000859, 050604,''
and in its place add ``000010, 000859,''; and in paragraph (b)(3),
remove ``050604'' and in its place add ``000010''.

Sec.  520.1196   [Amended]

0
17. In Sec.  520.1196, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  520.1197   [Amended]

0
18. In Sec.  520.1197, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  520.1198   [Amended]

0
19. In Sec.  520.1198, in paragraphs (b)(1) and (3), remove ``050604''
and in its place add ``000010''.

Sec.  520.1615   [Amended]

0
20. In Sec.  520.1615, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  520.1696c   [Amended]

0
21. In Sec.  520.1696c, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  520.1696d   [Amended]

0
22. In Sec.  520.1696d, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

0
23. In Sec.  520.1760, revise paragraphs (a) and (c)(1) to read as
follows:

Sec.  520.1760   Phenylpropanolamine.

    (a) Specifications--(1) Each chewable tablet contains 25, 50, or 75
milligram (mg) phenylpropanolamine hydrochloride.
    (2) Each extended-release tablet contains 18, 38, 74, or 145 mg
phenylpropanolamine hydrochloride.
* * * * *
    (c) * * *
    (1) Amount--Administer orally as follows:
    (i) Chewable tablet: 2 mg/kg of body weight twice daily.
    (ii) Extended-release tablet: 2 to 4 mg/kg of body weight once
daily with food.
* * * * *

Sec.  520.1855   [Amended]

0
24. In Sec.  520.1855, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  520.2170   [Amended]

0
25. In Sec.  520.2170, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  520.2380a   [Amended]

0
26. In Sec.  520.2380a, in paragraph (b)(2), remove ``050604'' and in
its place add ``000010''.

Sec.  520.2380b   [Amended]

0
27. In Sec.  520.2380b, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  520.2380c   [Amended]

0
28. In Sec.  520.2380c, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  520.2380d   [Amended]

0
29. In Sec.  520.2380d, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec. Sec.  520.2380e and 520.2380f   [Redesignated as Sec. Sec.
520.2380f and 520.2380e]

0
30. Redesignate Sec. Sec.  520.2380e and 520.2380f as Sec. Sec.
520.2380f and 520.2380e, respectively.

Sec.  520.2380e   [Amended]

0
31. In newly redesignated Sec.  520.2380e, in paragraph (b), remove
``050604'' and in its place add ``000010''.

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

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

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

Sec.  522.144   [Amended]

0
33. In Sec.  522.144, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

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

Sec.  522.313b   Ceftiofur hydrochloride.

    (a) Specifications. Each milliliter of suspension contains:
    (1) Ceftiofur hydrochloride equivalent to 50 milligrams (mg) of
ceftiofur equivalents in the inactive vehicles phospholipan 90H,
sorbitan monooleate, and cottonseed oil;
    (2) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur
equivalents in the inactive vehicle miglyol oil 812; or
    (3) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur
equivalents in the inactive vehicles aluminum monostearate, sorbitan
monooleate, and medium chain triglycerides.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter as
follows:
    (1) No. 054771 for products described in paragraphs (a)(1) and (2)
of this section; and

    (2) No. 055529 for the product described in paragraph (a)(3) of
this section.
* * * * *
    (e) * * *
    (2) * * *
    (iii) Limitations--(A) For products described in paragraphs (a)(2)
and (3) of this section: Treated cattle must not be slaughtered for 3
days following the last treatment. For products described in paragraph
(a)(2) of this section: Treated cattle must not be slaughtered for 4
days following the last treatment.
    (B) A withdrawal period has not been established in preruminating
calves. Do not use in calves to be processed for veal.

Sec.  522.814   [Amended]

0
35. In Sec.  522.814, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  522.850   [Amended]

0
36. In Sec.  522.850, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  522.930   [Amended]

0
37. In Sec.  522.930, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  522.1014   [Amended]

0
38. In Sec.  522.1014, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  522.1077   [Amended]

0
39. In Sec.  522.1077, in paragraph (b)(4), remove ``050604'' and in
its place add ``000010''.

Sec.  522.1145   [Amended]

0
40. In Sec.  522.1145, in paragraph (e)(2)(i), remove ``050604'' and in
its place add ``000010''.

Sec.  522.1150   [Amended]

0
41. In Sec.  522.1150, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

0
42. In Sec.  522.1160, revise paragraphs (b)(1) and (2); redesignate
the text of paragraph (c)(1)(i) as paragraph (c)(1)(i)(A); add a
paragraph heading to newly redesignated paragraph (c)(1)(i)(A); and add
paragraph (c)(1)(i)(B).
    The revision and addition read as follows:

Sec.  522.1160   Insulin.

* * * * *
    (b) * * *
    (1) No. 000061 for use of product described in paragraph (a)(1) as
in paragraphs (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(A),
(c)(2)(ii), and (c)(2)(iii) of this section.
    (2) No. 000010 for use of product described in paragraph (a)(2) as
in paragraphs (c)(1)(i)(B), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(B),
(c)(2)(ii), and (c)(2)(iii) of this section.
    (c) * * *
    (1) * * *
    (i) * * *
    (A) Porcine zinc insulin zinc. * * *
    (B) Protamine zinc recombinant human insulin. Administer a starting
dose of 0.2 to 0.5 IU/pound of body weight (0.5 to 1.0 IU/kg) once
daily. When transitioning from another insulin product, this form of
insulin should be started once daily, regardless of the frequency of
prior insulin use. The dose should be given concurrently with or right
after a meal. Reevaluate the dog at appropriate intervals and adjust
the dose based on both clinical signs and laboratory test results until
adequate glycemic control has been attained. Twice-daily therapy should
be initiated if the duration of insulin action is determined to be
inadequate. If twice-daily treatment is initiated, the two doses should
be 25 percent less than the once daily dose required to attain an
acceptable nadir.
* * * * *

Sec.  522.1192   [Amended]

0
43. In Sec.  522.1192, in paragraph (b)(1), remove ``050604'' and in
its place add ``000010''.

0
44. In Sec.  522.1193, revise paragraphs (b) and (e)(3) to read as
follows:

Sec.  522.1193   Ivermectin and clorsulon.

* * * * *
    (b) Sponsors. See Nos. 000010, 055529, 058005, and 061133 in Sec.
510.600(c) of this chapter.
* * * * *
    (e) * * *
    (3) Limitations--(i) Nos. 000010 and 061133: Do not treat cattle
within 21 days of slaughter. Nos. 055529 and 058005: Do not treat
cattle within 49 days of slaughter.
    (ii) Because a withdrawal time in milk has not been established, do
not use in female dairy cattle of breeding age. A withdrawal period has
not been established for this product in preruminating calves. Do not
use in calves to be processed for veal.

Sec.  522.1362   [Amended]

0
45. In Sec.  522.1362, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  522.1452   [Amended]

0
46. In Sec.  522.1452, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  522.1885   [Amended]

0
47. In Sec.  522.1885, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
48. The authority citation for part 524 continues to read as follows:

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

Sec.  524.814   [Amended]

0
49. In Sec.  524.814, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  524.815   [Amended]

0
50. In Sec.  524.815, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  524.916   [Removed]

0
51. Effective August 19, 2019, remove Sec.  524.916.

Sec.  524.1193   [Amended]

0
52. In Sec.  524.1193, in paragraph (b)(1), remove ``050604'' and in
its place add ``000010''.

Sec.  524.1484g   [Amended]

0
53. In Sec.  524.1484g, in paragraph (b), remove ``026637 and 050604''
and in its place add ``000010 and 026637''.

Sec.  524.1484j   [Amended]

0
54. In Sec.  524.1484j, in paragraph (b), remove ``050604'' and in its
place add ``000010''.

Sec.  524.2101   [Amended]

0
55. In Sec.  524.2101, in paragraph (b), remove ``000061, 017135, and
050604'' and in its place add ``000010, 000061, and 017135''.

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

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

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

Sec.  558.58  [Amended]

0
57. In Sec.  558.58, redesignate paragraphs (e)(3) through (6) as
paragraphs (e)(2) through (5), and redesignate paragraph (e)(9) as new
paragraph (e)(6).

Sec.  558.76  [Amended]

0
58. In Sec.  558.76, redesignate paragraphs (e)(1)(ix) through (xvi) as
paragraphs (e)(1)(vii) through (xiv).

0
59. In Sec.  558.128, revise paragraphs (b)(1) and (e)(4)(xv),
redesignate paragraphs (e)(4)(xvi) through (xxvi) as paragraphs
(e)(4)(xvii) through (xxvii), and add new paragraph (e)(4)(xvi).
    The revisions and addition read as follows:

Sec.  558.128  Chlortetracycline.

* * * * *
    (b) * * *
    (1) No. 054771: 50, 70, 80, 90, or 100 grams per pound (g/lb) Type
A medicated article.
* * * * *
    (e) * * *
    (4) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
       Chlortetracycline amount         Combination in grams/ton       Indications for use                     Limitations                    Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
(xv) 350 mg/head/day..................  ........................  1. Beef cattle: For control    To sponsor No. 054771 under NADAs 046-                *
                                                                   of bacterial pneumonia         699 and 049-287, No. 066104 under NADA
                                                                   associated with shipping       092-286, and No. 069254 under NADA 048-
                                                                   fever complex caused by        480: Withdraw 48 hours prior to
                                                                   Pasteurella spp. susceptible   slaughter. To sponsor No. 069254 under
                                                                   to chlortetracycline.          NADA 138-935 and ANADA 200-510: Zero
                                                                                withdrawal period.
                                                                  2. Beef cattle (under 700      To sponsor No. 054771 under NADAs 046-                *
                                                                   lb): For control of active     699 and 049-287, No. 066104 under NADA
                                                                   infection of anaplasmosis      092-286, and No. 069254 under NADA 048-
                                                                   caused by A. marginale         480: Withdraw 48 h prior to slaughter.
                                                                   susceptible to                 To sponsor No. 054771 under NADA 048-
                                                                   chlortetracycline.             761 and No. 069254 under NADA 138-935
                                                                                and ANADA 200-510: Zero withdrawal
                                                                                time.
(xvi) 20 to 350 g/ton.................  ........................  Beef cattle and replacement    Feed to provide chlortetracycline at             054771
                                                                   dairy heifers: For control     the rate of 350 mg per head per day.
                                                                   of bacterial pneumonia         This drug is not approved for use in
                                                                   associated with shipping       female dairy cattle 20 months of age
                                                                   fever complex caused by        or older, including dry dairy cows.
                                                                   Pasteurella spp. susceptible   Use in these cattle may cause drug
                                                                   to chlortetracycline.          residues in milk and/or in calves born
                                                                                to these cows. A withdrawal period has
                                                                                not been established for this product
                                                                                in pre-ruminating calves. Do not use
                                                                                in calves to be processed for veal. To
                                                                                sponsor No. 054771 under NADA 048-761:
                                                                                Zero withdrawal period.

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

* * * * *

Sec.  558.235  [Amended]

0
60. Effective September 9, 2019, in Sec.  558.235, in paragraph (b),
remove ``050604'' and in its place add ``000010''.

0
61. Revise Sec.  558.254 to read as follows:

Sec.  558.254  Famphur.

    (a) Specifications. Type A medicated articles containing 13.2 or
33.3 percent famphur.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.273 of this chapter.
    (d) Special considerations. Famphur is a cholinesterase inhibitor.
Do not use this product in animals simultaneously or within a few days
before or after treatment with or exposure to cholinesterase-inhibiting
drugs, pesticides, or chemicals.
    (e) Conditions of use. It is used in cattle feed as follows:

----------------------------------------------------------------------------------------------------------------
        Famphur in grams/ton               Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1.1 milligrams per pound (mg/lb)  Beef cattle and nonlactating  Feed for 30 days. Withdraw            000061
 body weight per day.                  dairy cows: For control of    from dry dairy cows and
                                       grubs and as an aid in        heifers 21 days prior to
                                       control of sucking lice.      freshening. Withdraw 4 days
                                                                     prior to slaughter.
(ii) 2.3 mg/lb body weight per day..  Beef cattle and nonlactating  Feed for 10 days. Withdraw            000061
                                       dairy cows: For control of    from dry dairy cows and
                                       grubs.                        heifers 21 days prior to
                                                                     freshening. Withdraw 4 days
                                                                     prior to slaughter.
----------------------------------------------------------------------------------------------------------------

Sec.  558.300  [Amended]

0
62. In Sec.  558.300, in paragraph (b), remove ``050604'' and in its
place add ``No. 000010''; in paragraphs (e)(1) through (6), in the
``Sponsor'' column, remove ``050604'' and in its place add ``000010'';
and remove paragraph (f).

Sec.  558.325  [Amended]

0
63. Effective August 19, 2019, in Sec.  558.325, remove paragraphs
(e)(2)(iii), (x), and (xvi); and redesignate paragraphs (e)(2)(iv)
through (ix) as paragraphs (e)(2)(iii) through (viii), paragraphs
(e)(2)(xi) through (xv) as paragraphs (e)(2)(ix) through (xiii), and
paragraph (e)(2)(xvii) as paragraph (e)(2)(xiv).

0
64. Revise Sec.  558.360 to read as follows:

Sec.  558.360  Morantel.

    (a) Specifications. Each pound of Type A medicated article contains
88 grams morantel tartrate.
    (b) Sponsor. See No. 066104 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.425 of this chapter.
    (d) Special considerations--(1) Do not use in Type B or Type C
medicated feeds containing bentonite.

    (2) Consult your veterinarian before using in severely debilitated
animals and for assistance in the diagnosis, treatment, and control of
parasitism.
    (e) Conditions of use. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
   Morantel tartrate in grams/ton          Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 0.44 to 4.4 grams of morantel     Cattle: For removal and       Feed as a single therapeutic          066104
 tartrate per pound of feed.           control of mature             treatment at 0.44 gram of
                                       gastrointestinal nematode     morantel tartrate per 100
                                       infections of cattle          pounds of body weight.
                                       including stomach worms       Fresh water should be
                                       (Haemonchus spp.,             available at all times.
                                       Ostertagia spp.,              When medicated feed is
                                       Trichostrongylus spp.),       consumed, resume normal
                                       worms of the small            feeding. Conditions of
                                       intestine (Cooperia spp.,     constant worm exposure may
                                       Trichostrongylus spp.,        require retreatment in 2 to
                                       Nematodirus spp.), and        4 weeks. Do not treat
                                       worms of the large            cattle within 14 days of
                                       intestine (Oesophagostomum    slaughter.
                                       radiatum).
(2) 0.44 to 4.4 grams of morantel     Goats: For removal and        Feed as a single therapeutic          066104
 tartrate per pound of feed.           control of mature             treatment at 0.44 gram of
                                       gastrointestinal nematode     morantel tartrate per 100
                                       infections of goats           pounds of body weight.
                                       including Haemonchus          Fresh water should be
                                       contortus, Ostertagia         available at all times.
                                       (Teladorsagia)                When medicated feed is
                                       circumcincta, and             consumed, resume normal
                                       Trichostrongylus axei.        feeding. Conditions of
                                                                     constant worm exposure may
                                                                     require retreatment in 2 to
                                                                     4 weeks. Do not treat goats
                                                                     within 30 days of slaughter.
----------------------------------------------------------------------------------------------------------------

0
65. Revise Sec.  558.600 to read as follows:

Sec.  558.600  Thiabendazole.

    (a) Specifications. Dry Type A medicated articles containing 22,
44.1, 66.1, or 88.2 percent thiabendazole. The 66.1 percent Type A
medicated article is solely for the manufacture of cane molasses liquid
Type B feed, which is mixed in dry feeds. The 88.2 percent Type A
medicated article is used solely for the manufacture of an aqueous
slurry for adding to a Type C dry cattle feed.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.730 of this chapter.
    (d) Special considerations. Do not use in Type B or Type C
medicated feed containing bentonite.
    (e) Conditions of use. It is used in feed for animals as follows:
    (1) Swine--

----------------------------------------------------------------------------------------------------------------
     Thiabendazole in grams/ton            Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 45.4 to 908 (0.005 to 0.1         Swine: As an aid in the       Administer continuously in            000010
 percent).                             prevention of infections of   feed containing 0.05 to 0.1
                                       large roundworms (genus       percent thiabendazole per
                                       Ascaris).                     ton for 2 weeks followed by
                                                                     feed containing 0.005 to
                                                                     0.02 percent thiabendazole
                                                                     per ton for 8 to 14 weeks.
                                                                     Do not treat animals within
                                                                     30 days of slaughter.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

    (2) Cattle--

----------------------------------------------------------------------------------------------------------------
        Thiabendazole amount               Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 3 grams per 100 lb. body weight.  For control of infections of  Use 3 grams per 100 lb. body          000010
                                       gastrointestinal roundworms   weight at a single dose;
                                       (Trichostrongylus spp.,       may repeat once in 2 to 3
                                       Haemonchus spp., Ostertagia   weeks. Do not treat animals
                                       spp., Nematodirus spp.,       within 3 days of slaughter.
                                       Oesophagostomum radiatum).    Milk taken from treated
                                                                     animals within 96 hours (8
                                                                     milkings) after the latest
                                                                     treatment must not be used
                                                                     for food.
(ii) 5 grams per 100 lb. body weight  For control of severe         Use 5 grams per 100 lb. body          000010
                                       infections of                 weight at a single dose or
                                       gastrointestinal roundworms   divided into 3 equal doses,
                                       (Trichostrongylus spp.,       administered 1 dose each
                                       Haemonchus spp., Ostertagia   day, on succeeding days.
                                       spp., Nematodirus spp.,       May repeat once in 2 to 3
                                       Oesophagostomum radiatum);    weeks. Do not treat animals
                                       control of infections of      within 3 days of slaughter.
                                       Cooperia spp.                 Milk taken from treated
                                                                     animals within 96 hours (8
                                                                     milkings) after the latest
                                                                     treatment must not be used
                                                                     for food.
----------------------------------------------------------------------------------------------------------------

    (3) Minor species--

----------------------------------------------------------------------------------------------------------------
        Thiabendazole amount               Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 2 grams per 100 lb. body weight.  Sheep and goats: For control  Use 2 grams per 100 lb. body          050604
                                       of infections of              weight at a single dose. Do
                                       gastrointestinal roundworms   not treat animals within 30
                                       (Trichostrongylus spp.,       days of slaughter. Milk
                                       Haemonchus spp., Ostertagia   taken from treated animals
                                       spp., Cooperia spp.;          within 96 hours (8
                                       Nematodirus spp.,             milkings) after the latest
                                       Bunostomum spp.,              treatment must not be used
                                       Strongyloides spp.,           for food.
                                       Chabertia spp., and
                                       Oesophagostomum spp.); also
                                       active against ova and
                                       larvae passed by sheep from
                                       3 hours to 3 days after the
                                       feed is consumed (good
                                       activity against ova and
                                       larvae of T. colubriformis
                                       and axei, Ostertagia spp.,
                                       Nematodirus spp.,
                                       Strongyloides spp.; less
                                       effective against those of
                                       Haemonchus contortus and
                                       Oesophagostomum spp.).
(ii) 3 grams per 100 lb. body weight  Goats: For control of severe  Use 3 grams per 100 lb. body          050604
                                       infections of                 weight at a single dose. Do
                                       gastrointestinal roundworms   not treat animals within 30
                                       (Trichostrongylus spp.,       days of slaughter. Milk
                                       Haemonchus spp., Ostertagia   taken from treated animals
                                       spp., Cooperia spp.,          within 96 hours (8
                                       Nematodirus spp.,             milkings) after the latest
                                       Bunostomum spp.,              treatment must not be used
                                       Strongyloides spp.,           for food.
                                       Chabertia spp., and
                                       Oesophagostomum spp.).
(iii) 454 grams per ton of feed.....  Pheasants: For the treatment  Feed continuously for 2               050604
                                       of gapeworms (Syngamus        weeks (14 days). Do not use
                                       trachea).                     treated pheasants for food
                                                                     for 21 days after last day
                                                                     of treatment. Fertility,
                                                                     hatchability, and other
                                                                     reproductive data are not
                                                                     available on use in
                                                                     breeding animals.
----------------------------------------------------------------------------------------------------------------

    Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16884 Filed 8-8-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 24 (Wednesday, February 5, 2020)]
[Rules and Regulations]
[Pages 6422-6424]
[FR Doc No: 2020-02130]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0764; Airspace Docket No. 19-AGL-25]
RIN 2120-AA66

Amendment of Class E Airspace; Winona, MN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends the Class E airspace extending upward from
700 feet above the surface at Winona Municipal Airport-Max Conrad
Field, Winona, MN. This action is due to an airspace review caused by
the decommissioning of the Winona VHF omnidirectional range (VOR)
navigation aid, which provided navigation information for the
instrument procedures at this airport. The geographic coordinates of
the airport are also being updated to coincide with the FAA's
aeronautical database.

DATES: Effective 0901 UTC, May 21, 2020. The Director of the Federal
Register approves this incorporation by reference action under Title 1
Code of Federal Regulations part 51, subject to the annual revision of
FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11D, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Rebecca Shelby, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the Class E airspace extending upward from 700 feet above
the surface at Winona Municipal Airport-Max Conrad Field, Winona, MN,
to support IFR operations at this airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (84 FR 54525; October 10, 2019) for Docket No. FAA-2019-0764
to amend the Class E airspace extending upward from 700 feet above the
surface at Winona Municipal Airport-Max Conrad Field, Winona, MN.
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11D, dated August 8, 2019, and effective September 15,
2019, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11D, Airspace Designations and
Reporting Points, dated August 8, 2019, and effective September 15,
2019. FAA Order 7400.11D is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11D lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71 amends the Class E airspace extending upward from 700 feet
above the surface to within 6.6-mile radius (decreased from a 7-mile
radius) of the Winona Municipal Airport-Max Conrad Field, and within 4-
miles each side of the 119[deg] bearing from the airport extending from
the 6.6-mile radius to 11.6 miles southeast of the airport, and within
2-mile each side of the 299[deg] bearing from the airport extending
from the 6.6 miles radius to 9.3 miles northwest of the airport,
removing the exclusion verbiage as it is no longer required and
updating the geographic coordinates of the airport to coincide with the
FAA's aeronautical database.
    This action is necessary due to an airspace review caused by the
decommissioning of the Winona VOR, which provided navigation
information for the instrument procedures at this airport.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL MN E5 Winona, MN [Amended]

Winona Municipal Airport-Max Conrad Field, MN
    (Lat. 44[deg]04'47'' N, long. 91[deg]42'42'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Winona Municipal Airport-Max Conrad
Field, and within 4 miles each side of the 119[deg] bearing from the
airport extending from the 6.6-mile radius to 11.6 miles southeast
the airport, and within 2 miles each side of the 299[deg] bearing
from the airport extending from the 6.6-mile radius to 9.3 miles
northwest of the airport.

    Issued in Fort Worth, Texas, on January 29, 2020.
Steve Szukala,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2020-02130 Filed 2-4-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: June 28, 2010 (Volume 75, Number 123)]
[Proposed Rules]
[Page 36609]
[DOCID:fr28jn10-26]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 271 and 272

[EPA-R06-RCRA-2009-0708; FRL-9162-1]

Arkansas: Final Authorization of State-Initiated Changes and
Incorporation by Reference of State Hazardous Waste Management Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: During a review of Arkansas' regulations, the EPA identified a
variety of State-initiated changes to Arkansas' hazardous waste program
under the Resource Conservation and Recovery Act, as amended (RCRA),
for which the State had not previously sought authorization. The EPA
proposes to authorize the State for the program changes. In addition,
the EPA proposes to codify in the regulations entitled ``Approved State
Hazardous Waste Management Programs'', Arkansas' authorized hazardous
waste program. The EPA will incorporate by reference into the Code of
Federal Regulations (CFR) those provisions of the State regulations
that are authorized and that EPA will enforce under RCRA.

DATES: Send written comments by July 28, 2010.

ADDRESSES: Send written comments to Alima Patterson, Region 6, Regional
Authorization Coordinator, (6PD-O), Multimedia Planning and Permitting
Division, EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733,
phone number<PHONE_NUMBER>. You may also submit comments
electronically or through hand delivery/courier; please follow the
detailed instructions in the ADDRESSES section of the direct final rule
which is located in the Rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Alima Patterson,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the ``Rules and Regulations'' section of
this Federal Register, the EPA is authorizing the changes to the
Arkansas program, and codifying and incorporating by reference the
State's hazardous waste program as a direct final rule. The EPA did not
make a proposal prior to the direct final rule because we believe these
actions are not controversial and do not expect comments that oppose
them. We have explained the reasons for this authorization and
incorporation by reference in the preamble to the direct final rule.
Unless we get written comments which oppose this authorization and
incorporation by reference during the comment period, the direct final
rule will become effective on the date it establishes, and we will not
take further action on this proposal. If we get comments that oppose
these actions, we will withdraw the direct final rule and it will not
take effect. We will then respond to public comments in a later final
rule based on this proposal. You may not have another opportunity for
comment. If you want to comment on this action, you must do so at this
time.
    For additional information, please see the direct final rule
published in the ``Rules and Regulations'' section of this Federal
Register.

    Dated: May 5, 2010.
Lawerence E. Starfield,
Regional Administrator, EPA Region 6.
[FR Doc. 2010-15333 Filed 6-25-10; 8:45 am]
BILLING CODE 6560-50-P