[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Rules and Regulations]
[Pages 27693-27701]
[FR Doc No: 2023-09212]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 516, 520, 522, 524, 526, 529, 556, and 558

[Docket No. FDA-2023-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications

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), abbreviated new animal drug
applications (ANADAs), and conditionally approved new animal drug
applications (cNADAs) during January, February, and March 2023. 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 improve their
accuracy and readability.

DATES: This rule is effective May 3, 2023.

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 protected].

SUPPLEMENTARY INFORMATION:

I. Approvals

    FDA is amending the animal drug regulations to reflect approval
actions for NADAs, ANADAs, and cNADAs during January, February, and
March 2023, 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,<PHONE_NUMBER>. Persons
with access to the internet may obtain these documents at the CVM FOIA
Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.

   Table 1--Original and Supplemental NADAs, ANADAs, and cNADAs Approved During January, February, and March 2023 Requiring Evidence of Safety and/or
                                                                      Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                21 CFR
         Approval date            File No.          Sponsor              Product name        Effect of the action        Public documents       section
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 5, 2023................    200-732  Felix Pharmaceuticals   Carprofen Tablets       Original approval for   FOI Summary..............    520.304
                                             Pvt. Ltd., 25-28        (carprofen tablets)     the relief of pain
                                             North Wall Quay,        Caplets.                and inflammation
                                             Dublin 1, Ireland.                              associated with
                                                                                osteoarthritis and
                                                                                for the control of
                                                                                postoperative pain
                                                                                associated with soft
                                                                                tissue and orthopedic
                                                                                surgeries in dogs as
                                                                                a generic copy of
                                                                                NADA 141-053.
January 11, 2023...............    200-611  Akorn Operating         DETOMISED (detomidine   Original approval as a  FOI Summary..............    522.536
                                             Company LLC, 5605       hydrochloride)          sedative and
                                             Centerpoint Ct.,        Injectable Solution.    analgesic to
                                             Suite A, Gurnee, IL                             facilitate minor
                                             60031.                                          surgical and
                                                                                diagnostic procedures
                                                                                in horses as a
                                                                                generic copy of NADA
                                                                                140-862.
January 11, 2023...............    200-738  Aurora Pharmaceutical,  DECTOGARD (doramectin   Original approval for   FOI Summary..............    524.770
                                             Inc., 1196 Highway 3    topical solution)       treatment and control
                                             South, Northfield, MN   Topical Solution.       of internal and
                                             55057-3009.                                     external parasites of
                                                                                cattle as a generic
                                                                                copy of NADA 141-095.
January 12, 2023...............    141-426  Intervet, Inc., 2       BRAVECTO (fluralaner)   Supplemental approval   FOI Summary..............    520.998
                                             Giralda Farms,          Chewable tablets.       for the treatment and
                                             Madison, NJ 07940.                              control of Asian long
                                                                                horned tick
                                                                                infestations for 12
                                                                                weeks in dogs and
                                                                                puppies.
January 12, 2023...............    200-721  Norbrook Laboratories   MIDAMOX for Cats        Supplemental approval   FOI Summary..............   524.1146
                                             Ltd., Carnbane          (imidacloprid and       for prevention of
                                             Industrial Estate,      moxidectin) Topical     heartworm disease and
                                             Newry, County Down,     Solution.               treatment of flea
                                             BT35 6QQ, United                                infestations in
                                             Kingdom.                                        ferrets as a generic
                                                                                copy of NADA 141-254.
January 12, 2023...............    200-733  Felix Pharmaceuticals   Marbofloxacin Chewable  Original approval for   FOI Summary..............   520.1310
                                             Pvt. Ltd., 25-28        Tablets                 treatment of
                                             North Wall Quay,        (marbofloxacin).        infections in dogs
                                             Dublin 1, Ireland.                              and cats associated
                                                                                with bacteria
                                                                                susceptible to
                                                                                marbofloxacin as a
                                                                                generic copy of NADA
                                                                                141-151.
January 12, 2023...............    200-734  Do....................  Praziquantel Tablets    Original approval for   FOI Summary..............   520.1870
                                                                     (praziquantel).         removal or removal
                                                                                and control of
                                                                                certain canine
                                                                                tapeworms as a
                                                                                generic copy of NADA
                                                                                111-798.
January 13, 2023...............    200-735  ZyVet Animal Health,    Dexmedetomidine         Original approval for   FOI Summary..............    522.558
                                             Inc., 73 Route 31N,     Hydrochloride           use as a sedative,
                                             Pennington, NJ 08534.   (dexmedetomidine        analgesic, and
                                                                     hydrochloride)          preanesthetic in dogs
                                                                     Injectable Solution.    and cats as a generic
                                                                                copy of NADA 141-267.
January 13, 2023...............    200-736  Do....................  Marbofloxacin Tablets   Original approval for   FOI Summary..............   520.1310
                                                                     (marbofloxacin).        treatment of
                                                                                infections in dogs
                                                                                and cats associated
                                                                                with bacteria
                                                                                susceptible to
                                                                                marbofloxacin as a
                                                                                generic copy of NADA
                                                                                141-151.
February 2, 2023...............    200-737  Do....................  Enrofloxacin            Original approval for   FOI Summary..............    520.812
                                                                     (enrofloxacin)          the management of
                                                                     Flavored                diseases associated
                                                                     Antimicrobial Tablets.  with bacteria
                                                                                susceptible to
                                                                                enrofloxacin in dogs
                                                                                and cats as a generic
                                                                                copy of NADA 140-441.
February 2, 2023...............    200-739  Do....................  Carprofen (carprofen)   Original approval for   FOI Summary..............    520.304
                                                                     Chewable Tablets.       the relief of pain
                                                                                and inflammation
                                                                                associated with
                                                                                osteoarthritis and
                                                                                for the control of
                                                                                postoperative pain
                                                                                associated with soft
                                                                                tissue and orthopedic
                                                                                surgeries in dogs as
                                                                                a generic copy of
                                                                                NADA 141-111.
February 9, 2023...............    200-701  Chanelle                PARASEDGE Multi for     Supplemental approval   FOI Summary..............   524.1146
                                             Pharmaceuticals         Cats (imidacloprid      for prevention of
                                             Manufacturing Ltd.,     and moxidectin)         heartworm disease and
                                             Loughrea, County        Topical Solution.       treatment of flea
                                             Galway, Ireland.                                infestations in
                                                                                ferrets as a generic
                                                                                copy of NADA 141-254.

February 24, 2023..............    200-741  Aurora Pharmaceutical,  EPRIGARD                Original approval for   FOI Summary..............    524.814
                                             Inc., 1196 Highway 3    (eprinomectin)          treatment and control
                                             South, Northfield, MN   Topical Solution.       of internal and
                                             55057-3009.                                     external parasites in
                                                                                cattle as a generic
                                                                                copy of NADA 141-079.
March 21, 2023.................    200-743  Provetica LLC, 8735     MODULIS for Dogs        Original approval for   FOI Summary..............    520.522
                                             Rosehill Rd., Suite     (cyclosporine oral      the control of atopic
                                             300, Lenexa, KS 66215.  solution) USP           dermatitis in dogs as
                                                                     MODIFIED.               a generic copy of
                                                                                NADA 141-218.
March 21, 2023.................    200-745  Parnell Technologies    RESPIRMYCIN 25          Original approval for   FOI Summary..............   522.2630
                                             Pty. Ltd., Unit 4,      (tulathromycin          the treatment of
                                             476 Gardeners Rd.,      injection) Injectable   respiratory disease
                                             Alexandria, New South   Solution.               in swine and calves
                                             Wales 2015, Australia.                          as a generic copy of
                                                                                NADA 141-349.
March 29, 2023.................    200-744  Provetica LLC, 8735     MODULIS for Cats        Original approval for   FOI Summary..............    520.522
                                             Rosehill Rd., Suite     (cyclosporine oral      the control of feline
                                             300, Lenexa, KS 66215.  solution) USP           allergic dermatitis
                                                                     MODIFIED.               in cats as a generic
                                                                                copy of NADA 141-329.
March 30, 2023.................    200-746  Norbrook Laboratories   TAURAMOX (moxidectin)   Original approval for   FOI Summary..............   522.1450
                                             Ltd., Carnbane          Injectable Solution.    treatment and control
                                             Industrial Estate,                              of internal and
                                             Newry, County Down,                             external parasites in
                                             BT35 6QQ, United                                beef and nonlactating
                                             Kingdom.                                        dairy cattle as a
                                                                                generic copy of NADA
                                                                                141-220.
March 31, 2023.................    200-747  ZyVet Animal Health,    Maropitant Citrate      Original approval for   FOI Summary..............   520.1315
                                             Inc., 73 Route 31N,     (maropitant citrate)    the prevention of
                                             Pennington, NJ 08534.   Tablets.                acute vomiting and
                                                                                the prevention of
                                                                                vomiting due to
                                                                                motion sickness in
                                                                                dogs as a generic
                                                                                copy of NADA 141-262.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Also, FDA is amending the animal drug regulations to reflect
approval of supplemental applications, as listed in table 2, to change
the marketing status of dosage form antimicrobial animal drug products
from over the counter (OTC) to by veterinary prescription (Rx). These
applications were submitted in voluntary compliance with the goals of
the FDA Center for Veterinary Medicine's (CVM's) Judicious Use
Initiative as identified by guidance for industry #263,
``Recommendations for Sponsors of Medically Important Antimicrobial
Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary
Oversight All Products That Continue to be Available Over-the-
Counter,'' June 11, 2021 (https://www.fda.gov/media/130610/download).

  Table 2--Supplemental Applications Approved During January, February, and March 2023 To Change the Marketing
                           Status of Antimicrobial Animal Drug Products From OTC to Rx
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                                                                                21 CFR
             Approval date                File No.           Sponsor              Product name         section
----------------------------------------------------------------------------------------------------------------
January 3, 2022.......................      200-274  Zoetis Inc., 333        LINCOMIX (lincomycin       522.1260
                                                      Portage St.,            hydrochloride)
                                                      Kalamazoo, MI 49007.    Injectable Solution.
January 12, 2022......................      012-123  Bimeda Animal Health    GALLIMYCIN 100              522.820
                                                      Ltd., 1B The Herbert    Injection
                                                      Building, The Park,     (erythromycin)
                                                      Carrickmines, Dublin    Injectable Solution.
                                                      18, Ireland.
January 12, 2022......................      130-952  Intervet, Inc., 2       GENTOCIN Pinkeye Spray    524.1044e
                                                      Giralda Farms,          (gentamicin) Topical
                                                      Madison, NJ 07940.      Spray.
January 13, 2022......................      008-774  Huvepharma EEOD, 5th    SULMET (sodium             522.2260
                                                      Floor, 3A Nikolay       sulfamethazine)
                                                      Haytov Str., 1113       Injectable Solution.
                                                      Sofia, Bulgaria.
February 10, 2023.....................      065-506  Bimeda Animal Health    COMBI-PEN-48              522.1696a
                                                      Ltd., 1B The Herbert    (penicillin G
                                                      Building, The Park,     benzathine and
                                                      Carrickmines, Dublin    penicillin G
                                                      18, Ireland.            procaine) Injectable
                                                                              Suspension.
February 14, 2023.....................      055-018  Huvepharma EOOD, 5th    Chlortetracycline           520.443
                                                      Floor, 3A Nikolay       (chlortetracycline
                                                      Haytov Str., 1113       hydrochloride)
                                                      Sofia, Bulgaria.        Tablets, 25 mg.
February 15, 2023.....................      033-157  Do....................  SPECTAM Scour-Halt        520.2123c
                                                                              (spectinomycin) Oral
                                                                              Solution.
February 15, 2023.....................      040-040  Do....................  SPECTAM                    522.2120
                                                                              (spectinomycin)
                                                                              Injectable Solution.
February 24, 2023.....................      065-010  Do....................  NOROCILLIN (penicillin    522.1696b
                                                                              G procaine)
                                                                              Injectable Suspension.
March 1, 2023.........................      200-351  Do....................  Lincomycin Injectable,     522.1260
                                                                              USP.
March 1, 2023.........................      200-368  Do....................  Lincomycin Injectable,     522.1260
                                                                              USP.
March 1, 2023.........................      130-464  Intervet, Inc., 2       GARACIN Pig Pump          520.1044b
                                                      Giralda Farms,          (gentamicin) Oral
                                                      Madison, NJ 07940.      Solution.

March 9, 2023.........................      035-456  Bimeda Animal Health    GALLIMYCIN-36               526.820
                                                      Ltd., 1B The Herbert    (erythromycin)
                                                      Building, The Park,     Intramammary Solution.
                                                      Carrickmines, Dublin
                                                      18, Ireland.
March 13, 2023........................      200-315  Sparhawk Laboratories,  LINCOMYCIN<PHONE_NUMBER>
                                                      Inc., 12340 Santa Fe    (lincomycin
                                                      Trail Dr., Lenexa, KS   hydrochloride)
                                                      66215.                  Injectable Solution.
March 16, 2023........................      065-505  Bimeda Animal Health    PRO-PEN-G (penicillin     522.1696b
                                                      Ltd., 1B The Herbert    G procaine)
                                                      Building, The Park,     Injectable Suspension.
                                                      Carrickmines, Dublin
                                                      18, Ireland.
March 20, 2023........................      200-127  Zoetis Inc., 333        PROSPEC (spectinomycin     522.2120
                                                      Portage St.,            hydrochloride)
                                                      Kalamazoo, MI 49007.    Injectable Solution.
March 25, 2023........................      040-181  Huvepharma EOOD, 5th    VETSULID                   520.2200
                                                      Floor, 3A Nikolay       (sulfachlorpyridazine
                                                      Haytov Str., 1113       ) Oral Suspension.
                                                      Sofia, Bulgaria.
March 28, 2023........................      065-081  HQ Specialty Pharma     MASTI-CLEAR                526.1696
                                                      Corp., 120 Rte. 17      (penicillin G
                                                      North, Suite 130,       procaine) Suspension
                                                      Paramus, NJ 07652.      and GO-DRY
                                                                              (penicillin G
                                                                              procaine) Suspension.
----------------------------------------------------------------------------------------------------------------

II. Withdrawals of Approval

    Elanco US Inc. (Elanco), 2500 Innovation Way, Greenfield, IN 46140
has requested that FDA withdraw approval of conditionally approved NADA
141-527 for BAYTRIL 100-CA1 (enrofloxacin) Injectable Solution.
Pursuant to Elanco's request, approval of their application was
withdrawn on March 31, 2023. As provided in the regulatory text of this
document, the animal drug regulations in 21 CFR 516.812 are removed to
reflect this action.
    Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd.,
Duluth, GA 30096 has requested that FDA withdraw approval of the 49
applications listed in table 3 because the products are no longer
manufactured or marketed. As provided in the regulatory text of this
document, the animal drug regulations are amended where appropriate to
reflect this action.

                    Table 3--Applications for Which Approval Was Voluntarily Withdrawn by FDA
----------------------------------------------------------------------------------------------------------------
                    File No.                                         Product name                    21 CFR cite
----------------------------------------------------------------------------------------------------------------
006-623.........................................  CAPARSOLATE (arsenamide sodium) Injectable                 Not
                                                   Solution.                                            codified
008-422.........................................  SELEEN (selenium disulfide) Topical Suspension...     524.2101
010-424.........................................  NALLINE (nalorphine hydrochloride) Injectable         522.1452
                                                   Solution.
011-080.........................................  HYDELTRONE-TBA (prednisolone tertiary                 522.1885
                                                   butylacetate) Injectable Suspension.
011-437.........................................  HYDELTRONE (neomycin sulfate and prednisolone        524.1484j
                                                   sodium phosphate) Ointment.
011-532.........................................  SULFABROM (sulfabromomethazine sodium) Bolus.....     520.2170
011-678.........................................  DIURIL (chlorothiazide) Tablets..................      520.420
012-734.........................................  DIURIL (chlorothiazide) Bolus....................      520.420
013-022.........................................  THIBENZOLE (thiabendazole) Sheep & Goat Wormer...    520.2380c
013-407.........................................  EQUIZOLE (thiabendazole) Horse Wormer Top Dress..    520.2380a
013-624.........................................  Triamcinolone Acetonide Tablets..................     520.2483
013-674.........................................  HYDROZIDE (hydrochlorothiazide) Injectable            522.1150
                                                   Solution.
013-954.........................................  THIBENZOLE (thiabendazole) 20% Swine Premix......      558.600
014-350.........................................  OMNIZOLE (thiabendazole) Oral Liquid.............    520.2380b
015-123.........................................  TBZ (thiabendazole) Cattle Wormer Oral Liquid....    520.2380b
015-875.........................................  TBZ 200 (thiabendazole) Medicated Feed Premix....      558.600
030-103.........................................  THIBENZOLE (thiabendazole) Oral Liquid...........    520.2380b
032-702.........................................  PROM ACE (acepromazine maleate) Tablets..........       520.23
033-127.........................................  VETISULID (sulfachlorpyridazine) Bolus...........     520.2200
033-318.........................................  VETISULID (sulfachlorpyridazine) Injectable           520.2200
                                                   Solution.
033-319.........................................  VETISULID (sulfachlorpyridazine) Tablets.........     520.2200
034-114.........................................  EQUIZOLE (thiabendazole) Oral Liquid.............    520.2380b
034-879.........................................  DOPRAM-V (doxapram hydrochloride) Injectable           522.775
                                                   Solution.
035-631.........................................  THIBENZOLE (thiabendazole) Pig Wormer............    520.2380b
037-410.........................................  EQUIZOLE A (thiabendazole and piperazine             520.2380e
                                                   phosphate) Oral Liquid.
043-141.........................................  THIBENZOLE 300 (thiabendazole) Medicated.........      558.600
044-654.........................................  EQUIZOLE (thiabendazole) Horse Wormer Pellets....    520.2380a
046-146.........................................  VETALOG (triamcinolone acetonide) Cream..........     524.2483
047-333.........................................  EQUIZOLE A (thiabendazole and piperazine citrate)    520.2380d
                                                   Oral Liquid.
048-487.........................................  TBZ (thiabendazole) Wormer Paste 50%.............    520.2380b
049-461.........................................  TBZ (thiabendazole) Wormer Paste 43%.............    520.2380b
055-021.........................................  HETACIN K (hetacillin potassium) Capsules Vet....     520.1130
055-022.........................................  HETACIN K (hetacillin potassium) Tablets.........     520.1130
055-048.........................................  HETACIN K (hetacillin potassium) Oral Liquid.....     520.1130
065-275.........................................  Penicillin VK (penicillin V potassium) Filmtab       520.1696c
                                                   Tablets 250 mg.
065-276.........................................  VEESYN (penicillin V potassium) Granules for Oral    520.1696b
                                                   Solution.
093-600.........................................  VOREN (dexamethasone-21-isonicotinate) Suspension      522.542

094-642.........................................  CAMVET (cambendazole) Suspension Horse Wormer....     520.284a
095-642.........................................  OXY-TET (oxytetracycline hydrochloride)              522.1662a
                                                   Injectable Solution.
096-506.........................................  CAMVET (cambendazole) Horse Wormer Pellets.......     520.284b
096-731.........................................  CAMVET (cambendazole) Horse Wormer Paste 45%.....     520.284c
098-689.........................................  EQUIZOLE (thiabendazole) 50% Wormer Paste........    520.2380b
099-388.........................................  VETALOG (triamcinolone acetonide) Oral Powder....     520.2483
117-531.........................................  Acepromazine Maleate Injection...................       522.23
127-443.........................................  EQVALAN (ivermectin) Injectable Solution.........     522.1192
140-439.........................................  EQVALAN (ivermectin) Oral Liquid For Horses......     522.1195
141-180.........................................  TORPEX (albuterol sulfate).......................       529.40
200-361.........................................  Acepromazine Maleate Injection...................       522.23
200-564.........................................  Ivermectin Paste 1.87%...........................     520.1192
----------------------------------------------------------------------------------------------------------------

III. Technical Amendments

    FDA is making the following amendments to improve the accuracy of
the animal drug regulations.
     21 CFR 520.48 is amended to reflect the sponsors of
products containing altrenogest for use in horses and swine.
     21 CFR 520.2380 is removed and 21 CFR 558.600 revised to
characterize a free-choice block containing thiabendazole as a new
animal drug for use in cattle feed.
     21 CFR 522.1077 is amended to reflect indications for use
of gonadorelin in cattle.
     21 CFR 522.1222 is amended to reflect sponsors of approved
applications for use of ketamine in cats and subhuman primates.
     21 CFR 556.620 is removed because there are no longer any
approved products containing sulfabromomethazine for use in food-
producing animals.
     21 CFR 556.730 is revised to reflect the removal of
products containing thiabendazole for use in food-producing animals
other than cattle.
     21 CFR 558.311 is amended to reflect approved classes of
pasture cattle for use of lasalocid medicated feeds.
     21 CFR 558.455 is amended to reflect the approved
conditions of use of medicated feeds containing oxytetracycline and
neomycin in sheep.

IV. 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 Part 516

    Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 524, 526, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Dairy products, Foods, Meat and meat products.

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, 516, 520, 522, 524, 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:
0
a. In paragraph (c)(1), amend the table by adding an entry for
``Provetica LLC''; and
0
b. In paragraph (c)(2), amend the table by adding add an entry for
``086097''.
    The additions read as follows:

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

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

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

                              * * * * * * *
Provetica LLC, 8735 Rosehill Rd., Suite 300,                      086097
 Lenexa, KS 66215.................................

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

    (2) * * *

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

                              * * * * * * *
086097......................  Provetica LLC, 8735 Rosehill Rd., Suite
                               300, Lenexa, KS 66215.

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

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
3. The authority citation for part 516 continues to read as follows:

    Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

Sec.  516.812  [Removed]

0
4. Remove Sec.  516.812.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
6. In Sec.  520.48, revise paragraph (b) to read as follows:

Sec.  520.48  Altrenogest.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter:
    (1) Nos. 000061 and 051072 for use as in paragraph (d) of this
section.
    (2) No. 061133 for use as in paragraph (d)(1) of this section.
    (3) No. 013744 for use as in paragraph (d)(2) of this section.
* * * * *

Sec. Sec.  520.284, 520.284a, 520.284b, and 520.284c  [Removed]

0
7. Remove Sec. Sec.  520.284, 520.284a, 520.284b, and 520.284c.

0
8. In Sec.  520.304, revise paragraphs (b)(1) and (2) to read as
follows:

Sec.  520.304  Carprofen.

* * * * *
    (b) * * *
    (1) Nos. 017033, 054771, 055529, 062250, and 086101 for use of
products described in paragraph (a)(1) and (2) of this section as in
paragraph (c) of this section.
    (2) Nos. 058198 and 086117 for use of product described in
paragraph (a)(2) as in paragraph (c) of this section.
* * * * *

Sec. Sec.  520.420  [Removed]

0
9. Remove Sec.  520.420.

0
10. In Sec.  520.443, amend paragraph (d)(2)(ii) by adding a sentence
at the end of the paragraph to read as follows:

Sec.  520.443  Chlortetracycline tablets and boluses.

* * * * *
    (d) * * *
    (2) * * *
    (ii) * * * Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
* * * * *

0
11. In Sec.  520.522, add paragraph (b)(4) and revise (d)(2)(ii) to
read as follows:

Sec.  520.522  Cyclosporine.

* * * * *
    (b) * * *
    (4) No. 086097 for use of product described in paragraph (a)(2) as
in paragraph (d) of this section.
* * * * *
    (d) * * *
    (2) * * *
    (ii) Indications for use. For the control of feline allergic
dermatitis as manifested by excoriations (including facial and neck),
miliary dermatitis, eosinophilic plaques, and self-induced alopecia in
cats at least 6 months of age and at least 3 lbs (1.4 kg) in body
weight.
* * * * *

Sec.  520.812  [Amended]

0
12. Amend Sec.  520.812 by:
0
a. In paragraph (b)(2), removing ``No. 017033'' and in its place adding
``Nos. 017033 and 086117''; and
0
b. Removing paragraph (b)(4).

0
13. In Sec.  520.998, revise paragraph (c)(2)(i) to read as follows:

Sec.  520.998  Fluralaner.

* * * * *
    (c) * * *
    (2) * * *
    (i) Chewable tablets described in paragraph (a)(1) of this section.
Kills adult fleas; for the treatment and prevention of flea
infestations (Ctenocephalides felis), and the treatment and control of
tick infestations (Ixodes scapularis (black-legged tick), Dermacentor
variabilis (American dog tick), Rhipicephalus sanguineus (brown dog
tick), and Haemaphysalis longicornis (Asian longhorned tick)) for 12
weeks in dogs and puppies 6 months of age and older, and weighing 4.4
lbs or greater; and for the treatment and control of Amblyomma
americanum (lone star tick) infestations for 8 weeks in dogs and
puppies 6 months of age and older, and weighing 4.4 lbs or greater.
* * * * *

0
14. Amend Sec.  520.1044b by adding a sentence at the end of paragraph
(d)(3) to read as follows:

Sec.  520.1044b  [Amended]

* * * * *
    (d) * * *
    (3) * * * Federal law restricts this drug to use by or on the order
of a licensed veterinarian.

Sec.  520.1130  [Removed]

0
15. Remove Sec. Sec.  520.1130.

Sec.  520.1195  [Amended]

0
16. In Sec.  520.1195, in paragraph (b)(1), remove ``000010,''.

0
17. In Sec.  520.1310, revise paragraphs (a) and (b) to read as
follows:

Sec.  520.1310  Marbofloxacin.

    (a) Specifications. Each tablet or chewable tablet contains 25, 50,
100, or 200 milligrams (mg) marbofloxacin.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for
use as in paragraph (d) of this section:
    (1) Nos. 017033, 054771, and 086117 for use of tablets.
    (2) No. 086101 for use of chewable tablets.
* * * * *

0
18. In Sec.  520.1315, revise paragraph (b) to read as follows:

Sec.  520.1315  Maropitant.

* * * * *
    (b) Sponsors. See Nos. 054771 and 086117 in Sec.  510.600(c) of
this chapter.
* * * * *

Sec.  520.1696b  [Removed]

0
19. Remove Sec.  520.1696b.

0
20. In Sec.  520.1696c, revise paragraph (b) to read as follows:

Sec.  520.1696c  Penicillin V tablets.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *

Sec.  520.1870  [Amended]

0
21. In Sec.  520.1870, in paragraph (b)(2), remove ``No. 069043'' and
in its place add ``Nos. 069043 and 086101''.

0
22. In Sec.  520.2200, revise paragraph (a)(2), remove paragraph
(a)(3), revise paragraphs (d)(1)(i) and (d)(2)(i), and remove (d)(3) to
read as follows:

Sec.  520.2200  Sulfachlorpyridazine.

    (a) * * *
    (2) Each milliliter (mL) of suspension contains 50 milligrams (mg)
of sodium sulfachlorpyridazine.
* * * * *
    (d) * * *
    (1) * * *
    (i) Amount. Administer 30 to 45 mg sulfachlorpyridazine powder per
pound (/lb) of body weight per day in milk or milk replacer in divided
doses twice daily for 1 to 5 days.
* * * * *
    (2) * * *
    (i) Amount. Administer 20 to 35 mg/lb body weight per day in
divided doses twice daily for 1 to 5 days in drinking water or an oral
suspension containing 50 mg per mL.
* * * * *

Sec.  Sec.  520.1696b, 520.2170, 520.2380, 520.2380a, 520.2380b,
520.2380c, 520.2380d and 520.2380e   [Removed]

0
23. Remove Sec. Sec.  520.1696b, 520.2170, 520.2380, 520.2380a,
520.2380b, 520.2380c, 520.2380d and 520.2380e.

Sec.  520.2380f  [Redesignated]

0
24. Redesignate Sec.  520.2380f as Sec.  520.2382.

Sec.  520.2483  [Removed]

0
25. Remove Sec.  520.2483.

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

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

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

Sec.  522.536  [Amended]

0
27. In Sec.  522.536, in paragraph (b), remove ``Nos. 015914 and
052483'' and in its place add ``Nos. 015914, 052483, and 059399''.

Sec.  522.542  [Removed]

0
28. Remove Sec.  522.542.

Sec.  522.558  [Amended]

0
29. In Sec.  522.558, in paragraph (b)(1), remove ``Nos. 017033 and
059399'' and in its place add ``Nos. 017033, 059399, and 086117''.

Sec.  522.775  [Removed]

0
30. Remove Sec.  522.775.

0
31. Amend Sec.  522.820 by adding a sentence at the end of paragraph
(d)(3)(iii) to read as follows:

Sec.  522.820  Erythromycin.

* * * * *
    (d) * * *
    (3) * * *
    (iii) * * * Federal law restricts this drug to use by or on the
order of a licensed veterinarian.

0
32. In Sec.  522.1077, revise paragraphs (b)(2), (d)(1)(iv), and
(e)(1)(i) to read as follows:

Sec.  522.1077  Gonadorelin.

* * * * *
    (b) * * *
    (2) No. 068504 for use of the 100-[micro]g/mL product described in
paragraph (a)(2) as in paragraphs (d)(1)(i) and (iv) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (iv) Dinoprost injection for use as in paragraph (e)(1)(vi) of this
section as provided by No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *
    (e) * * *
    (1) * * *
    (i) For the treatment of ovarian follicular cysts in dairy cattle:
Administer 86 [micro]g gonadorelin (No. 000061), or 100 [micro]g
gonadorelin diacetate tetrahydrate (Nos. 000010 and 061133), or 100
[micro]g gonadorelin (as gonadorelin acetate; No. 068504) by
intramuscular or intravenous injection.
* * * * *

Sec.  522.1150  [Removed]

0
33. Remove Sec.  522.1150.

0
34. In Sec.  522.1192, remove and reserve paragraph (a)(1), and revise
paragraphs (b)(1) and (2), remove and reserve paragraph (e)(1), and
revise paragraph (e)(2)(i) to read as follows:

Sec.  522.1192  Ivermectin.

* * * * *
    (b) * * *
    (1) Nos. 000010, 016592, 055529, 058005, and 061133 for use of the
product described in paragraph (a)(2) of this section as in paragraphs
(e)(2) through (e)(5) of this section; and
    (2) No. 000010 for use of the product described in paragraph (a)(3)
of this section as in paragraphs (e)(3) and (e)(6) of this section.
* * * * *
    (e) * * *
    (2) * * *
    (i) Amount. 200 micrograms per kilogram ([micro]g/kg) of body
weight by subcutaneous injection.
* * * * *

Sec.  522.1222  [Amended]

0
35. In Sec.  522.1222, revise paragraph (b) by adding, in numeric
sequence, ``00010,''.

0
36. In Sec.  522.1450, revise paragraphs (a), (b), and (e) to read as
follows:

Sec.  522.1450  Moxidectin solution.

    (a) Specifications. Each milliliter (mL) of solution contains 10
milligrams (mg) moxidectin.
    (b) Sponsors. See Nos. 055529 and 058198 in Sec.  510.600(c) of
this chapter.
* * * * *
    (e) Conditions of use in cattle--(1) Amount. Administer by
subcutaneous injection 1 mL for each 110 pounds (lb) (50 kilograms
(kg)) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body
weight.
    (2) Indications for use. Beef and nonlactating dairy cattle: For
treatment and control of Gastrointestinal roundworms: Ostertagia
ostertagi (adults, fourth-stage larvae, and inhibited larvae),
Haemonchus placei (adults), Trichostrongylus axei (adults and fourth-
stage larvae), Trichostrongylus colubriformis (adults and fourth-stage
larvae), Cooperia oncophora (adults), Cooperia pectinata (adults),
Cooperia punctata (adults and fourth-stage larvae), Cooperia spatulata
(adults), Cooperia surnabada (adults

and fourth-stage larvae), Nematodirus helvetianus (adults),
Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris
spp. (adults); Lungworms: Dictyocaulus viviparus (adults and fourth-
stage larvae); Cattle grubs: Hypoderma bovis and Hypoderma lineatum;
Mites: Psoroptes ovis (Psoroptes communis var. bovis); Lice:
Linognathus vituli and Solenopotes capillatus. For protection from
reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum
for 42 days after treatment, with Haemonchus placei for 35 days after
treatment, and with Ostertagia ostertagi and Trichostrongylus axei for
14 days after treatment.
    (3) Limitations. Cattle must not be slaughtered for human
consumption within 21 days of treatment. This drug product is not
approved for use in female dairy cattle 20 months of age or older,
including dry dairy cows. Use in these cattle may cause drug residues
in milk and/or in calves born to these cows. A withdrawal period has
not been established for preruminating calves. Do not use in calves to
be processed for veal.

Sec.  522.1696b  [Amended]

0
37. In Sec.  522.1696b, amend paragraph (d)(2)(iii)(C), by removing
``For Nos. 054771 and 055529:''.

Sec.  522.1885  [Removed]

0
38. Remove Sec.  522.1885.

0
39. Amend Sec.  522.2120 by adding a sentence at the end of paragraph
(d)(1)(ii) to read follows:

Sec.  522.2120  Spectinomycin hydrochloride.

* * * * *
    (d) * * *
    (1) * * *
    (ii) * * * Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
* * * * *

Sec.  522.2200  [Removed]

0
40. Remove Sec.  522.2200.

0
41. In 522.2630, revise paragraph (b)(2) to read as follows:

Sec.  522.2630  Tulathromycin.

* * * * *
    (b) * * *
    (2) Nos. 013744, 051311, 054771, 058198, and 068504 for use of
product described in paragraph (a)(2) as in paragraphs (d)(1)(i),
(d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of this section.
* * * * *

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

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

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

0
43. In Sec.  524.770, revise paragraph (b) to read as follows:

Sec.  524.770  Doramectin.

* * * * *
    (b) Sponsors. See Nos. 051072 and 054771 in Sec.  510.600(c) of
this chapter.
* * * * *

0
44. In Sec.  524.814, revise paragraphs (b) and (e)(1) to read as
follows:

Sec.  524.814  Eprinomectin.

* * * * *
    (b) Sponsors. See Nos. 000010, 051072, and 055529 in Sec.
510.600(c) of this chapter.
* * * * *
    (e) * * *
    (1) Amount. Apply 5 mg (1 mL) per 10 kilograms (kg) of body weight
(500 micrograms/kg) topically along backbone from withers to tailhead.
* * * * *

Sec.  524.1044e  [Amended]

0
45. Amend Sec.  524.1044e by adding a sentence at the end of paragraph
(d)(3) to read as follows:

Sec.  524.1044e  Gentamicin spray.

* * * * *
    (d) * * *
    (3) * * * Federal law restricts this drug to use by or on the order
of a licensed veterinarian.

Sec.  524.1146  [Amended]

0
46. In Sec.  524.1146, in paragraph (b)(3), remove ``Nos. 051072 and
058198'' and in its place add ``Nos. 051072, 055529, 058198, and
061651''.

Sec.  524.1484j  [Removed]

0
47. Remove Sec.  524.1484j.

Sec.  524.2101  [Amended]

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

Sec.  524.2483  [Amended]

0
49. In Sec.  524.2483, in paragraph (b), remove ``Nos. 000010 and
054925'' and in its place add ``No. 054925''.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
51. Amend Sec.  526.1696 by adding a sentence at the end of paragraph
(d)(3) and paragraph (e)(3) to read as follows:

Sec.  526.1696  Penicillin G procaine.

* * * * *
    (d) * * *
    (3) * * * For No. 042791: Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
    (e)
    (3) * * * For No. 042791: Federal law restricts this drug to use by
or on the order of a licensed veterinarian.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

Sec.  529.40  [Removed]

0
53. Remove Sec.  529.40.

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

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

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

Sec.  556.620  [Removed]

0
55. Remove Sec.  556.620.

0
56. Revise Sec.  556.730 to read as follows:

Sec.  556.730  Thiabendazole.

    (a) [Reserved]
    (b) Tolerances. The tolerances for thiabendazole are:
    (1) Cattle--(i) Edible tissues (excluding milk): 0.1 ppm.
    (ii) Milk: 0.05 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.600.

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

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

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

0
58. In Sec.  558.311, revise paragraph (e)(3)(iii) to read as follows:

Sec.  558.311  Lasalocid.

* * * * *
    (e) * * *
    (3) * * *

----------------------------------------------------------------------------------------------------------------
             Lasalocid amount                  Indications for use              Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(iii) Not less than 60 mg or more than     Pasture cattle (slaughter,   Feed continuously at a rate       054771
 300 mg of lasalocid per head per day.      stocker, feeder cattle,      of not less than 60 mg or
                                            and beef replacement         more than 300 mg of
                                            heifers): For increased      lasalocid per head per day
                                            rate of weight gain.         when on pasture. The drug
                                                                         must be contained in at
                                                                         least 1 pound of feed.
                                                                         Daily intakes of lasalocid
                                                                         in excess of 200 mg/head/
                                                                         day have not been shown to
                                                                         be more effective than 200
                                                                         mg/head/day.

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

* * * * *

0
50. In Sec.  558.455, revise paragraph (e)(5) to read as follows:

Sec.  558.455  Oxytetracycline and neomycin.

* * * * *
    (e) * * *
    (5) Sheep. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
   Oxytetracycline and neomycin sulfate
                  amount                       Indications for use              Limitations            Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight     Sheep: For treatment of      Feed continuously for 7 to        066104
 daily.                                     bacterial enteritis caused   14 days. Treatment should        069254
                                            by Escherichia coli and      continue 24 to 48 hours
                                            bacterial pneumonia caused   beyond remission of
                                            by Pasteurella multocida     clinical signs of disease.
                                            susceptible to               Withdraw 5 days before
                                            oxytetracycline; treatment   slaughter.
                                            and control of
                                            colibacillosis (bacterial
                                            enteritis) caused by E.
                                            coli susceptible to
                                            neomycin.
----------------------------------------------------------------------------------------------------------------

    (ii) [Reserved]

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

Sec.  558.600  Thiabendazole.

    (a) Specifications. Mineral protein block containing 3.3 percent
thiabendazole.
    (b) Sponsor. See No. 012286 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.730 of this chapter.
    (d) Special considerations. See Sec.  500.25 of this chapter.
    (e) Conditions of use in cattle--(1) Amount. Provide free-choice to
cattle on pasture or range accustomed to mineral protein block feeding
for 3 days. Cattle should consume at a recommended level of 0.11 pound
per 100 pounds of body weight per day. Animals maintained under
conditions of constant worm exposure may require re-treatment within 2
to 3 weeks.
    (2) Indications for use. For control of infections of
gastrointestinal roundworms (Trichostrongylus, Haemonchus, Ostertagia,
and Cooperia).
    (3) Limitations. Milk taken from animals during treatment and
within 96 hours (8 milkings) after the latest treatment must not be
used for food. Do not treat cattle within 3 days of slaughter.

    Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09212 Filed 5-2-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)]
[Notices]
[Page 25451]
[FR Doc No: 2018-11832]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9978-77-ORD]

Ambient Air Monitoring Reference and Equivalent Methods;
Designation of One New Reference Method

AGENCY: Office of Research and Development; Environmental Protection
Agency.

ACTION: Notice of the designation of a new reference method for
monitoring ambient air quality.

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

SUMMARY: Notice is hereby given that the Environmental Protection
Agency (EPA) has designated one new reference method for measuring
concentrations of nitrogen dioxide (NO2) in ambient air.

FOR FURTHER INFORMATION CONTACT: Robert Vanderpool, Exposure Methods
and Measurement Division (MD-D205-03), National Exposure Research
Laboratory, U.S. EPA, Research Triangle Park, North Carolina 27711.
Phone:<PHONE_NUMBER>. Email: [email protected].

SUPPLEMENTARY INFORMATION: In accordance with regulations at 40 CFR
part 53, the EPA evaluates various methods for monitoring the
concentrations of those ambient air pollutants for which EPA has
established National Ambient Air Quality Standards (NAAQS) as set forth
in 40 CFR part 50. Monitoring methods that are determined to meet
specific requirements for adequacy are designated by the EPA as either
reference or equivalent methods (as applicable), thereby permitting
their use under 40 CFR part 58 by States and other agencies for
determining compliance with the NAAQS. A list of all reference or
equivalent methods that have been previously designated by EPA may be
found at http://www.epa.gov/ttn/amtic/criteria.html.
    The EPA hereby announces the designation of one new reference
method for measuring concentrations of NO2 in ambient air.
This designation is made under the provisions of 40 CFR part 53, as
amended on October 26, 2015(80 FR 65291-65468).
    The new reference method for NO2 is an automated method
(analyzer) utilizing the measurement principle based on gas phase
chemiluminescence. This newly designated reference method is identified
as follows:
    RFNA-0418-250, ``Sabio Model 6040 Ambient NO/NO2/
NOX Analyzer'', operated in the measurement range of 0-0.5
PPM, an any ambient temperature in the range of 5-40 [deg]C, within a
line voltage range determined by the selected optional pump [115 VAC
external pump: 105-125 VAC (60 Hz); 230 VAC external pump: 210-250 VAC
(50-60 Hz); 24 VDC internal pump: 90-260 VAC (50-60 Hz)], at any sample
flow rate in the range of 0.50-0.75 L/min, in accordance with the
``Sabio Model 6040 Ambient NO/NO2/NOX Analyzer
Instruction Manual'', with or without optional zero/span ports for
external calibration, and with or without an optional inlet filter.
    This application for a reference method determination for this
NO2 method was received by the Office of Research and
Development on March 28, 2018. This analyzer is commercially available
from the applicant, Sutron Corporation, 21 Cypress Blvd., Suite 1130,
Round Rock, TX 78665.
    A representative test analyzer was tested in accordance with the
applicable test procedures specified in 40 CFR part 53, as amended on
October 26, 2015. After reviewing the results of those tests and other
information submitted by the applicant, EPA has determined, in
accordance with part 53, that this method should be designated as a
reference method.
    As a designated reference method, this method is acceptable for use
by states and other air monitoring agencies under the requirements of
40 CFR part 58, Ambient Air Quality Surveillance. For such purposes,
this method must be used in strict accordance with the operation or
instruction manual associated with the method and subject to any
specifications and limitations (e.g., configuration or operational
settings) specified in the designated method description (see the
identification of the method above).
    Use of the method also should be in general accordance with the
guidance and recommendations of applicable sections of the ``Quality
Assurance Handbook for Air Pollution Measurement Systems, Volume I,''
EPA/600/R-94/038a and ``Quality Assurance Handbook for Air Pollution
Measurement Systems, Volume II, Ambient Air Quality Monitoring
Program,'' EPA-454/B-13-003, (both available at http://www.epa.gov/ttn/amtic/qalist.html). Provisions concerning modification of such methods
by users are specified under Section 2.8 (Modifications of Methods by
Users) of Appendix C to 40 CFR part 58.
    Consistent or repeated noncompliance with any of these conditions
should be reported to: Director, Exposure Methods and Measurement
Division (MD-E205-01), National Exposure Research Laboratory, U.S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711.
    Designation of this reference method is intended to assist the
States in establishing and operating their air quality surveillance
systems under 40 CFR part 58. Questions concerning the commercial
availability or technical aspects of the method should be directed to
the applicant.

    Dated: May 21, 2018.
Timothy Watkins,
Director, National Exposure Research Laboratory.
[FR Doc. 2018-11832 Filed 5-31-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 133 (Thursday, July 11, 2013)]
[Rules and Regulations]
[Pages 41684-41685]
[FR Doc No: 2013-16596]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2012-0260; Special Conditions No. 25-494-SC]

Special Conditions: Embraer S.A. Model EMB-550 Airplanes, Sudden
Engine Stoppage

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions.

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

SUMMARY: These special conditions are issued for the Embraer Model EMB-
550 airplane. This airplane has novel or unusual design features as
compared to the state of technology envisioned in the airworthiness
standards for transport-category airplanes. These design features
include engine size and the potential torque loads imposed by sudden
engine stoppage. The applicable airworthiness regulations do not
contain adequate or appropriate safety standards for this design
feature. These special conditions contain the additional safety
standards that the Administrator considers necessary to establish a
level of safety equivalent to that established by the existing
airworthiness standards.

DATES: Effective Date: August 12, 2013.

FOR FURTHER INFORMATION CONTACT: Cindy Ashforth, FAA, International
Branch, ANM-116, Transport Airplane Directorate, Aircraft Certification
Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone
(425) 227-2768; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On May 14, 2009, Embraer applied for a type certificate for their
new Model EMB-550 airplane. The Model EMB-550 airplane is the first of
a new family of jets designed as a corporate jet, and for fractional,
charter, and private-owner operations. The airplane is a conventional
configuration with a low wing and T-tail empennage. The primary
structure is metal with composite empennage and control surfaces. The
Model EMB-550 airplane is designed for eight passengers, with a maximum
of 12 passengers (including toilet seat). It is equipped with two
Honeywell HTF7500-E medium-bypass-ratio turbofan jet engines mounted on
aft-fuselage pylons. Each engine produces approximately 6,540 lb of
thrust for normal takeoff. The primary flight-control systems are
electronically controlled using fly-by-wire (FBW) technology.
    The Model EMB-550 airplane incorporates novel or unusual design
features involving engine size and torque load that affect the airframe
as it relates to sudden engine-stoppage conditions.

Type Certification Basis

    Under the provisions of Title 14, Code of Federal Regulations (14
CFR) 21.17, Embraer must show that the Model EMB-550 airplane meets the
applicable provisions of part 25, as amended by Amendments 25-1 through
1-127.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Model EMB-550 airplane because of
a novel or unusual design feature, special conditions are prescribed
under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, the special conditions would also apply to the
other model.
    In addition to the applicable airworthiness regulations and special
conditions, the Model EMB-550 airplane must comply with the fuel-vent
and exhaust-emission requirements of 14 CFR part 34 and the noise-
certification requirements of 14 CFR part 36; and the FAA must issue a
finding of regulatory adequacy under Sec.  611 of Public Law 92-574,
the ``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type-
certification basis under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The Model EMB-550 airplane incorporates a novel or unusual design:
    The Embraer Model EMB-550 airplane will incorporate a medium-
bypass-ratio turbofan jet engine that will neither seize nor produce
transient torque loads in the same manner that is envisioned by current
Sec.  25.361(b)(1) regarding ``load that affect sudden engine
stoppage'' conditions.

Discussion of Comments

    Notice of Proposed Special Conditions No. 25-12-05-SC, for the
Embraer Model EMB-550 airplane, was published in the Federal Register
on September 25, 2012 (77 FR 58970). No comments were received, and the
special conditions are adopted as proposed.

Discussion

    The size, configuration, and failure modes of jet engines have
changed considerably from those envisioned by 14 CFR 25.361(b), when
the engine-seizure requirement was first adopted. Engines have become
larger and are now designed with large bypass fans capable of producing
much larger and more complex dynamic loads. Relative to the engine
configurations that existed when the rule was developed in 1957, the
present generation of engines is sufficiently different and novel to
justify issuance of a special condition to establish appropriate design
standards for the Embraer Model EMB-550 airplane type design.
    Consideration of the limit engine torque load imposed by sudden
engine stoppage due to malfunction or structural failure (such as
compressor jamming) has been a specific requirement for transport-
category airplanes since 1957. In the past, the design torque loads
associated with typical failure scenarios have been estimated by the
engine manufacturer and were provided to the airframe manufacturer as
limit loads. These limit loads were considered simple and pure torque
static loads.
    It is evident from service history that the engine-failure events
that tend to cause the most severe loads are fan-blade failures, which
occur much less frequently than the typical ``limit'' load condition.
    The regulatory authorities and industry have developed a
standardized requirement in the Aviation Rulemaking Advisory Committee
(ARAC) forum. The technical aspects of this requirement have been
agreed upon and have been accepted by the ARAC Loads and Dynamics
Harmonization Working Group, and incorporated in EASA CS-25. The
proposed special conditions outlined below reflect the ARAC
recommendation and CS-25. In addition, the ARAC recommendation includes
corresponding advisory material that is considered an acceptable means
of compliance to the proposed special conditions outlined below.
    To maintain the level of safety envisioned in Sec.  25.361(b), more

comprehensive criteria are needed for the new generation of high-bypass
engines. The special conditions would distinguish between the more
common engine-failure events and those rare events resulting from
structural failures. The more-common events would continue to be
treated as static torque limit load conditions. The more-severe events
resulting from extreme engine-failure conditions (such as loss of a
full fan blade at redline speed), would be treated as full dynamic-load
conditions. These would be considered ultimate loads, and include all
transient loads associated with the event. An additional safety factor
would be applied to the more-critical airframe supporting structure.

Applicability

    As discussed above, these special conditions are applicable to the
Model EMB-550 airplane. Should Embraer apply at a later date for a
change to the type certificate to include another model incorporating
the same novel or unusual design feature, the special conditions would
apply to that model as well.

Conclusion

    This action affects only certain novel or unusual design features
on one model of airplane. It is not a rule of general applicability.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for the Embraer Model EMB-550 airplane.
    In lieu of 14 CFR 25.361(b), the following special conditions
apply:
    1. For turbine-engine installations, the engine mounts, pylons, and
adjacent supporting airframe structure must be designed to withstand 1g
level flight loads acting simultaneously with the maximum limit torque
loads imposed by each of the following:
    (a) Sudden engine deceleration due to a malfunction, which could
result in a temporary loss of power or thrust, and
    (b) The maximum acceleration of the engine.
    2. For auxiliary power unit (APU) installations, the APU mounts and
adjacent supporting airframe structure must be designed to withstand 1g
level flight loads acting simultaneously with the maximum limit torque
loads imposed by each of the following:
    (a) Sudden APU deceleration due to malfunction or structural
failure; and
    (b) The maximum acceleration of the APU.
    3. For engine-supporting structure, an ultimate loading condition
must be considered that combines 1g flight loads with the transient
dynamic loads resulting from:
    (a) The loss of any fan, compressor, or turbine blade; and
separately
    (b) Where applicable to a specific engine design, any other engine
structural failure that results in higher loads.
    4. The ultimate loads developed from the conditions specified in
paragraphs 3(a) and 3(b) of these special conditions are to be
multiplied by a factor of 1.0 when applied to engine mounts and pylons,
and multiplied by a factor of 1.25 when applied to adjacent supporting
airframe structure.
    5. Any permanent deformation that results from the conditions
specified in paragraph 3 of these special conditions must not prevent
continued safe flight and landing.

    Issued in Renton, Washington, on June 21, 2013.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-16596 Filed 7-10-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 12, 2010 (Volume 75, Number 69)]
[Proposed Rules]
[Page 18451-18454]
[DOCID:fr12ap10-18]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0073]
RIN 1625-AA87

Safety and Security Zones; Tall Ships Challenge 2010, Great
Lakes; Cleveland, OH; Bay City, MI; Duluth, MN; Green Bay, WI; Chicago,
IL

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish temporary safety and
security zones around each Tall Ship visiting the Great Lakes during
the Tall Ships Challenge 2010 race series. These safety and security
zones will provide for the regulation of vessel traffic in the vicinity
of each Tall Ship in the navigable waters of the United States. The
Coast Guard is taking this action to safeguard participants and
spectators from the hazards associated with the limited maneuverability
of these Tall Ships and to ensure public safety during Tall Ships
events.

DATES: Comments and related material must be received by the Coast
Guard on or before May 12, 2010.

ADDRESSES: You may submit comments identified by docket number USCG-
2010-0073 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.

    To avoid duplication, please use only one of these methods. See the
``Public Participation and Request for Comments'' portion of the
SUPPLEMENTARY INFORMATION section below for instructions on submitting
comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or e-mail LT Yamaris Barril, Inspections, Prevention
Department, Ninth Coast Guard District, Cleveland, OH via telephone at
(216) 902-6343, or e-mail at<EMAIL_ADDRESS>    If you have questions on viewing or submitting material to the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2010-0073), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online, or by fax, mail or hand delivery, but please use only one of
these means. If you submit a comment online via http://
www.regulations.gov, it will be considered received by the Coast Guard
when you successfully transmit the comment. If you fax, hand deliver,
or mail your comment, it will be considered as having been received by
the Coast Guard when it is received at the Docket Management Facility.
We recommend that you include your name and a mailing address, an e-
mail address, or a telephone number in the body of your document so
that we can contact you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rule'' and insert ``USCG-2010-0073'' in the ``Keyword'' box.
Click ``Search'' then click on the balloon shape in the ``Actions''
column. If you submit your comments by mail or hand delivery, submit
them in an unbound format, no larger than 8\1/2\ by 11 inches, suitable
for copying and electronic filing. If you submit comments by mail and
would like to know that they reached the Facility, please enclose a
stamped, self-addressed postcard or envelope. We will consider all
comments and material received during the comment period and may change
the rule based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2010-0073'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the Docket Management Facility in Room W12-140 on
the ground floor of the Department of Transportation West Building,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one using one of the four methods specified under
ADDRESSES. Please, explain why you believe a public meeting would be
beneficial. If we determine that one would aid this rulemaking, we will
hold one at a time and place announced by a later notice in the Federal
Register.

Background and Purpose

    These temporary safety and security zones are necessary to protect
the Tall Ships from potential harm and to protect the public from the
hazards associated with the limited maneuverability of these types of
ships. Due to the high profile nature and extensive publicity
associated with this event, each Captain of the Port (COTP) expects a
large number of spectators in confined areas along the navigable waters
of the United States. Therefore, the Coast Guard is proposing to
implement a safety and security zone around each ship to ensure the
safety of all Tall Ships while they operate throughout the Great Lakes.
The combination of large numbers of recreational boaters, congested
waterways, boaters crossing commercially transited waterways, and low
maneuverability of the Tall Ships could easily result in serious
injuries or fatalities.

Discussion of Proposed Rule

    This proposed temporary final rule is intended to ensure the safety
of the public and vessels during the Tall Ships Challenge 2010. Tall
Ships will be participating in parades and then mooring for official
events in the harbors of Cleveland, OH; Bay City, MI; Duluth, MN; Green
Bay, WI; and Chicago, IL. Tall Ships may also visit other harbors while
in the Great Lakes.
    The Coast Guard proposes to establish temporary safety and security
zones around each Tall Ship participating in these events. These safety
and security zones will move with the Tall Ships as they travel
throughout the Great Lakes. The safety and security zones will be
effective from 12:01 a.m. June 23, 2010 through 12:01 a.m. on September
13, 2010.
    Upon the navigable waters of the United States, except as discussed
below, no vessel or person is allowed within 100 yards of a Tall Ship
that is underway or at anchor, unless authorized by the Captain of the
Port or the on-scene Official Patrol. Any vessel authorized to enter
into a Tall Ship safety and security zone must operate at the minimum
speed necessary to maintain a safe course and must proceed as directed
by the on-scene Official Patrol. Even if operating within a Tall Ship
safety and security zone under proper authority, except as discussed in
the following paragraph, no vessel or person is allowed within 25 yards
of a Tall Ship. In addition, upon the navigable waters of the United
States, no vessel or person is allowed within 25 yards of any Tall Ship
that is moored.
    Vessels constrained by their navigational draft or restricted in
their ability to maneuver are permitted to transit, in accordance with
the Navigational Rules, within 100 yards of a Tall Ship in order to
ensure a safe passage. When navigational constraints of channels,
rivers, or waterways prohibit vessels from remaining 100 or more yards
from a Tall Ship, such vessels are permitted to enter a security

and safety zone but must remain at the greatest possible distance away
from the Tall Ships while operating at the minimum speed necessary to
maintain a safe course.
    The Coast Guard expects the temporary final rule will be effective
less than 30 days after publication in the Federal Register because
delaying the effective date would be contrary to the public interest
due to the need to protect the public from the dangers associated with
the limited maneuverability during Tall Ships events.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order. We conclude that this
proposed rule is not a significant regulatory action because we
anticipate that it will have minimal impact on the economy, will not
interfere with other agencies, will not adversely alter the budget of
any grant or loan recipients, and will not raise any novel legal or
policy issues. The safety and security zone around each Tall Ship will
be relatively small. Because the safety and security zones will move
along the Tall Ships course through the Great Lakes, the zones will
exist for only a minimal time in any one particular geographical area
and restrictions on vessel movement within any particular geographical
area of the Great Lakes is expected to be minimal. Additionally, under
certain conditions vessels may still transit through the safety and
security zone when permitted by proper authority.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities because each zone will be relatively small and
vessels may still transit through a zone with permission from the
Official Patrol or when navigation restraints require. However, this
proposed rule would affect the following entities, some of which might
be small entities: The owners or operators of vessels intending to
transit or anchor in an area of water in which a participating Tall
Ship is transiting, anchored, or moored between 12:01 a.m. on June 23,
2010 and 12:01 a.m. on September 13, 2010.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
proposed rule would affect your small business, organization, or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please contact LT Yamaris Barril,
Inspections, Ninth Coast Guard District, Cleveland, OH at (216) 902-
6343. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or Tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    This proposed rule does not have Tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of

energy. The Administrator of the Office of Information and Regulatory
Affairs has not designated it as a significant energy action.
Therefore, it does not require a Statement of Energy Effects under
Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have
made a preliminary determination that this action is one of a category
of actions that do not individually or cumulatively have a significant
effect on the human environment. A preliminary environmental analysis
checklist supporting this determination is available in the docket
where indicated under ADDRESSES. This proposed rule involves the
establishment of a safety and security zone around each Tall Ship
participating in the Tall Ships Challenge 2010 race series. Based on
our preliminary determination, there are no factors in this case that
would limit the use of a categorical exclusion under section 2.B.2
figure 2-1, paragraph (34)(g) of the Instruction and neither an
environmental assessment nor a environmental impact statement is
required.
    We seek any comments or information that may lead to the discovery
of a significant environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.
    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

    1. The authority citation for part 165 continues to read as
follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and
160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland
Security Delegation No. 0170.1.

    2. Add Sec.  165.T09-0073 to read as follows:

Sec.  165.T09-0073  Safety and Security Zones; Tall Ships Challenge
2010; Great Lakes; Cleveland, OH; Bay City, MI; Duluth, MN; Green Bay,
WI; Chicago, IL

    (a) Definitions. The following definitions apply to this section:
    Navigation Rules means the Navigation Rules, International and
Inland (See, 1972 COLREGS and 33 U.S.C. 2001 et seq.).
    Official Patrol means those persons designated by Captain of the
Port Buffalo, Detroit, Sault Ste. Marie, Duluth and Lake Michigan to
monitor a Tall Ship safety and security zone, permit entry into the
zone, give legally enforceable orders to persons or vessels within the
zone, and take other actions authorized by the cognizant Captain of the
Port.
    Public Vessel means vessels owned, chartered, or operated by the
United States or by a State or political subdivision thereof.
    Tall Ship means any sailing vessel participating in the Tall Ships
Challenge 2010 in the Great Lakes. This includes, but is not limited
to, the following: Sailing Vessel (S/V) AMISTAD, S/V APPLEDORE IV, S/V
APPLEDORE V, HMS BOUNTY, S/V DENIS SULLIVAN, S/V EUROPA, S/V FAZISI, S/
V FRIENDS OF GOOD WILL, S/V INLAND SEAS, S/V LAREVENANTE, S/V LYNX, S/V
MADELINE, S/V FLAGSHIP NIAGARA, S/V PATHFINDER, S/V PLAYFAIR, S/V PRIDE
OF BALTIMORE II, S/V ROALD AMUNDSEN, S/V RED WITCH, S/V ROTALISTE, S/V
ROSEWAY, S/V UNICORN, S/V WELCOME, and S/V WINDY.
    (b) Location. The following area is a safety and security zone: all
navigable waters of the United States located in the Ninth Coast Guard
District within a 100 yard radius of any Tall Ship.
    (c) Regulations. (1) Entry into a safety and security zone
described in paragraph (b) of this section is prohibited unless
authorized by the cognizant Coast Guard Captain of the Port or the
Official Patrol.
    (2) Vessels may request permission to enter into a safety and
security zone described in paragraph (b) of this section by contacting
the Official Patrol on VHF channel 16.
    (3) Any vessel operating within a safety and security zone
established by this section must operate at the minimum speed necessary
to maintain a safe course and must proceed as directed by the Captain
of the Port or the on-scene Official Patrol. Any vessel or person
allowed to enter a safety and security zone established by this section
must still remain at least 25 yards from any Tall Ship, unless
authorized to come within such a distance pursuant to paragraph (c)(4)
of this section or permitted to come within such a distance by the
cognizant Captain of the Port, his or her designated representative, or
the on-scene Official Patrol.
    (4) Vessels are permitted to transit through the safety and
security zone in waterways that do not provide adequate navigable
waters greater than 100 yards from the Tall Ships. Vessels transiting
such areas must operate at the minimum speed necessary to maintain a
safe course while also maintaining the greatest possible distance away
from the Tall Ships.
    (d) Effective period. This rule is effective from 12:01 a.m. on
Wednesday, June 23, 2010 through 12:01 a.m. on Monday September 13,
2010.
    (e) Navigation Rules. The Navigation Rules must apply at all times
within a Tall Ships safety and security zone.
    (f) When a Tall Ship approaches within 25 yards of any vessel that
is moored or anchored, the stationary vessel must stay moored or
anchored while it remains within the Tall Ship's safety and security
zone unless ordered by or given permission from the cognizant Captain
of the Port, his or her designated representative, or the on-scene
official patrol to do otherwise.

    Dated: March 30, 2010.
Lorne W. Thomas,
Captain, U.S. Coast Guard, Acting Commander, Ninth Coast Guard
District.
[FR Doc. 2010-8204 Filed 4-9-10; 8:45 am]
BILLING CODE 9110-04-P