[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Rules and Regulations]
[Pages 16543-16550]
[FR Doc No: 2023-05465]

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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-2022-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor

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 October, November, and December 2022. 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 the
accuracy and readability of the regulations.

DATES: This rule is effective March 20, 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 October, November, and
December 2022, 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.
    FDA has verified the website addresses as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.

  Table 1--Original and Supplemental NADAs, ANADAs, and cNADAs Approved During October, November, and December 2022 Requiring Evidence of Safety and/or
                                                                      Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                21 CFR
           Approval date              File No.          Sponsor              Product name        Effect of the action     Public documents      section
--------------------------------------------------------------------------------------------------------------------------------------------------------
November 4, 2022...................    200-730  Parnell Technologies    RESPIRMYCIN             Original approval for   FOI Summary             522.2630
                                                 Pty. Ltd., Unit 4,      (tulathromycin          the treatment of
                                                 476 Gardeners Rd.,      injection) Injectable   bovine respiratory
                                                 Alexandria, New South   Solution.               disease, infectious
                                                 Wales 2015, Australia.                          bovine
                                                                                keratoconjunctivitis,
                                                                                and bovine foot rot
                                                                                as a generic copy of
                                                                                NADA 141-244.
November 14, 2022..................    141-567  Ishihara Sangyo         PANOQUELL-CA1           Conditional approval    FOI Summary             516.1012
                                                 Kaisha, Ltd., 3-15,     (fuzapladib sodium      for management of
                                                 Edobori 1-chome,        for injection) Powder   clinical signs
                                                 Nishi-ku, Osaka 550-    for injection.          associated with acute
                                                 0002, Japan.                                    onset of pancreatitis
                                                                                in dogs.
December 2, 2022...................    200-377  Bimeda Animal Health    LINXMED (lincomycin     Supplemental approval   FOI Summary            520.1263b
                                                 Ltd., 1B The Herbert    hydrochloride)          for control of
                                                 Building, The Park,     Soluble Powder.         American foulbrood in
                                                 Carrickmines, Dublin                            honey bees as a
                                                 18, Ireland.                                    generic copy of NADA
                                                                                111-636.
December 2, 2022...................    141-529  Pharmgate, Inc., 1800   PENNITRACIN             Original approval for   FOI Summary              558.364
                                                 Sir Tyler Dr.,          (bacitracin             the prevention of
                                                 Wilmington, NC 28405.   methylenedisalicylate   mortality caused by
                                                                         ) and MAXIBAN           necrotic enteritis
                                                                         (narasin and            and coccidiosis in
                                                                         nicarbazin).            broiler chickens.
December 8, 2022...................    141-566  Increvet, Inc., 200     BEXACAT (bexagliflozin  Original approval to    FOI Summary              520.170
                                                 Portland St., Floor     tablets) Tablets.       improve glycemic
                                                 3, Boston, MA 02114.                            control in otherwise
                                                                                healthy cats with
                                                                                diabetes mellitus not
                                                                                previously treated
                                                                                with insulin.
December 15, 2022..................    200-455  Bimeda Animal Health    BILOVET (tylosin        Original approval for   FOI Summary             520.2640
                                                 Ltd., 1B The Herbert    tartrate) Soluble       the control of
                                                 Building, The Park,     Powder.                 mortality caused by
                                                 Carrickmines, Dublin                            necrotic enteritis
                                                 18, Ireland.                                    associated with
                                                                                Clostridium
                                                                                perfringens in
                                                                                broiler chickens as a
                                                                                generic copy of NADA
                                                                                013-076.
December 20, 2022..................    141-559  Anzac Animal Health,    ZYCOSAN (pentosan       Original approval for   FOI Summary             522.1704
                                                 LLC, 218 Millwell       polysulfate sodium      the control of
                                                 Dr., Suite B,           injection) Injectable   clinical signs
                                                 Maryland Heights, MO    Solution.               associated with
                                                 63043.                                          osteoarthritis in
                                                                                horses.
December 23, 2022..................    141-450  Intervet, Inc., 2       BANAMINE Transdermal    Supplemental approval   FOI Summary              524.970
                                                 Giralda Farms,          (flunixin transdermal   for control of
                                                 Maison, NJ 07940.       solution) Transdermal   pyrexia associated
                                                                         Solution.               with acute bovine
                                                                                mastitis, for
                                                                                addition of lactating
                                                                                dairy cows for all
                                                                                approved indications,
                                                                                and of a milk discard
                                                                                time.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 October, November, and December 2022 To Change the Marketing
                           Status of Antimicrobial Animal Drug Products From OTC to Rx
----------------------------------------------------------------------------------------------------------------
           Approval date              File No.            Sponsor               Product name      21 CFR section
----------------------------------------------------------------------------------------------------------------
October 11, 2022..................      097-222  Boehringer Ingelheim       TODAY (cephapirin            526.365
                                                  Animal Health USA, Inc.,   sodium)
                                                  3239 Satellite Blvd.,      Intramammary
                                                  Duluth, GA 30096.          Infusion.

October 18, 2022..................      055-039  Huvepharma EOOD, 5th       Chlortetracycline            520.443
                                                  Floor, 3A Nikolay Haytov   Calf Oblets, 500 mg.
                                                  Str., 1113 Sofia,
                                                  Bulgaria.
October 31, 2022..................      034-025  Zoetis Inc., 333 Portage   LINCOMIX (lincomycin        522.1260
                                                  St., Kalamazoo, MI 49007.  hydrochloride)
                                                                             Injectable Solution.
November 2, 2022..................      065-498  Huvepharma EOOD, 5th       PEN BP-48                  522.1696a
                                                  Floor, 3A Nikolay Haytov   (penicillin G
                                                  Str., 1113 Sofia,          benzathine and
                                                  Bulgaria.                  penicillin G
                                                                             procaine)
                                                                             Injectable
                                                                             Suspension.
November 9, 2022..................      108-114  Boehringer Ingelheim       TOMORROW (cephapirin         526.363
                                                  Animal Health USA, Inc.,   benzathine)
                                                  3239 Satellite Blvd.,      Intramammary
                                                  Duluth, GA 30096.          Infusion.
November 15, 2022.................      065-010  Norbrook Laboratories      NOROCILLIN                 522.1696b
                                                  Ltd., Carnbane             (penicillin G
                                                  Industrial Estate,         procaine)
                                                  Newry, County Down, BT35   Injectable
                                                  6QQ, United Kingdom.       Suspension.
November 16, 2022.................      140-582  Bimeda Animal Health       BIOCYL-50                   522.1662
                                                  Ltd., 1B The Herbert       (oxytetracycline
                                                  Building, The Park,        hydrochloride)
                                                  Carrickmines, Dublin 18,   Injectable
                                                  Ireland.                   Solution; BIOCYL-
                                                                             100
                                                                             (oxytetracycline
                                                                             hydrochloride)
                                                                             Injectable Solution.
November 18, 2022.................      141-143  Norbrook Laboratories      NOROMYCIN 300 LA           522.1660b
                                                  Ltd., Carnbane             (oxytetracycline)
                                                  Industrial Estate,         Injectable Solution.
                                                  Newry, County Down, BT35
                                                  6QQ, United Kingdom.
November 30, 2022.................      031-715  Zoetis Inc., 333 Portage   ALBON                      520.2220d
                                                  St., Kalamazoo, MI 49007.  (sulfadimethoxine)
                                                                             Boluses.
November 30, 2022.................      122-271  Huvepharma EOOD, 5th       SULMET                     520.2260a
                                                  Floor, 3A Nikolay Haytov   (sulfamethazine)
                                                  Str., 1113 Sofia,          Oblets.
                                                  Bulgaria.
November 30, 2022.................      200-038  Do.......................  DI-METHOX                   522.2220
                                                                             (sulfadimethoxine)
                                                                             Injectable Solution.
December 2, 2022..................      101-862  Intervet, Inc., 2 Giralda  GARASOL (gentamicin         522.1044
                                                  Farms, Madison, NJ 07940.  sulfate) Injection.
December 7, 2022..................      065-174  Zoetis Inc., 333 Portage   CRYSTICILLIN<PHONE_NUMBER>b
                                                  St., Kalamazoo, MI 49007.  A.S. (penicillin G
                                                                             procaine)
                                                                             Injectable
                                                                             Suspension.
December 9, 2022..................      113-232  Do.......................  LIQUAMYCIN                 522.1660a
                                                                             LA[dash]200
                                                                             (oxytetracycline)
                                                                             Injectable Solution.
December 9, 2022..................      200-523  Bimeda Animal Health       SULFAMED                    522.2220
                                                  Ltd., 1B The Herbert       (sulfadimethoxine)
                                                  Building, The Park,        Injectable Solution.
                                                  Carrickmines, Dublin 18,
                                                  Ireland.
December 12, 2022.................      103-037  Intervet, Inc., 2 Giralda  GARACIN (gentamicin)        522.1044
                                                  Farms, Madison, NJ 07940.  Injectable Solution.
December 15, 2022.................      200-508  Bimeda Animal Health       BILOVET (tylosin)           522.2640
                                                  Ltd., 1B The Herbert       Injectable Solution.
                                                  Building, The Park,
                                                  Carrickmines, Dublin 18,
                                                  Ireland.
December 16, 2022.................      138-955  Huvepharma EOOD, 5th       TYLOVET (tylosin)           522.2640
                                                  Floor, 3A Nikolay Haytov   Injectable Solution.
                                                  Str., 1113 Sofia,
                                                  Bulgaria.
December 22, 2022.................      092-523  Intervet, Inc., 2 Giralda  GARASOL (gentamicin        529.1044b
                                                  Farms, Madison, NJ 07940.  sulfate) Solution.
----------------------------------------------------------------------------------------------------------------

II. Changes of Sponsorship

    Increvet, Inc., 200 Portland St., Floor 3, Boston, MA 02114 has
informed FDA that it has transferred ownership of, and all rights and
interest in, NADA 141-566 for BEXACAT (bexagliflozin tablets) Tablets,
approved December 8, 2022, to Elanco US Inc., 2500 Innovation Way,
Greenfield, IN 46140. The regulatory text for the original approval of
this application reflects this change of sponsorship.

III. Technical Amendments

    FDA is making the following amendments to improve the accuracy of
the animal drug regulations:
     21 CFR 516.498 is removed from subpart C of part 516 and
is added to subpart E.
     21 CFR 520.370, 520.522, 522.246, 522.304, 522.2470,
524.1044c, 524.1044f, and 524.1484g are amended to reflect a sponsor's
current drug labeler code.
     21 CFR 520.441 is amended to revise the sponsor listings
for uses of chlortetracycline in drinking water of various food-
producing animals.
     21 CFR 520.443 is amended to revise the sponsor listings
for uses of chlortetracycline tablets and boluses in calves.
     21 CFR 520.1196 is amended to revise the indication for
uses of ivermectin and pyrantel tablets in dogs.
     21 CFR 522. 1660a is amended to reflect the correct drug
labeler code for a sponsor of an oxytetracycline injectable solution.
     21 CFR 522.2471 is amended to add human food safety
warnings for use of tilmicosin injectable solution in cattle and sheep.
     21 CFR 524.1448 is amended to revise the indication for
use of mirtazapine transdermal ointment in cats.
     21 CFR 556.222 is amended to reflect a revised tolerance
for residues of doramectin in liver of cattle.
     21 CFR 556.500 is amended to reflect revised numbering of
sections for oxytetracycline uses in food-producing animals.
     21 CFR 558.76 is amended to add conditions of use
previously approved under NADA 141-137 for use of bacitracin
methylenedisalicylate in the manufacture of Type C medicated feeds for
broiler and replacement chickens (87 FR 76418, December 14, 2022).
     21 CFR 558.355 is amended to revise a caution statement on
labeling of monensin Type A medicated articles for use in broiler
breeder replacement chickens.

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, in the table in paragraph (c)(1), add entries in
alphabetical order for ``Ishihara Sangyo Kaisha, Ltd.'' and ``ZyVet
Animal Health, Inc.'' and in the table in paragraph (c)(2), add entries
in numerical order for ``064642'' and ``086117'' to read as follows:

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

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

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

                              * * * * * * *
Ishihara Sangyo Kaisha, Ltd., 3-15, Edobori 1-chome,              064642
 Nishi-ku, Osaka 550-0002, Japan........................

                              * * * * * * *
ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ           086117
 08534..................................................
------------------------------------------------------------------------

    (2) * * *

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

                              * * * * * * *
064642.......................  Ishihara Sangyo Kaisha, Ltd., 3-15,
                                Edobori 1-chome, Nishi-ku, Osaka 550-
                                0002, Japan.

                              * * * * * * *
086117.......................  ZyVet Animal Health, Inc., 73 Route 31N,
                                Pennington, NJ 08534.

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

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.  516.498  [Transferred to Subpart E]

0
4. Transfer Sec.  516.498 from subpart C to subpart E.

0
5. Add Sec.  516.1012 to read as follows:

Sec.  516.1012  Fuzapladib.

    (a) Specifications. The drug is provided as a powder for injection
that is reconstituted with 3.5 milliliter (mL) of provided diluent to a
final concentration of 4 milligrams (mg) fuzapladib sodium per mL.
    (b) Sponsor. See No. 064642 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer at a dosage of 0.4 mg
(0.1 mL) per kilogram of body weight once daily for 3 consecutive days
by intravenous (IV) injection over 15 seconds to 1 minute.
    (2) Indications for use in dogs. For the management of clinical
signs associated with acute onset of pancreatitis in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
7. Add Sec.  520.170 to read as follows:

Sec.  520.170  Bexagliflozin.

    (a) Specifications. Each tablet contains 15 milligrams
bexagliflozin.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer one tablet by mouth
to cats 6.6 lb (3.0 kg) or greater once daily, at approximately the
same time each day, with or without food, and regardless of blood
glucose level.
    (2) Indications for use. To improve glycemic control in otherwise
healthy cats with diabetes mellitus not previously treated with
insulin.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

Sec.  520.370  [Amended]

0
8. In Sec.  520.370, in paragraph (b)(1), remove ``026637'' and add in
its place ``017033''.

0
9. In Sec.  520.441, revise paragraphs (b)(1) and (3) and
(d)(4)(iii)(C) to read as follows:

Sec.  520.441  Chlortetracycline powder.

* * * * *
    (b) * * *
    (1) No. 069254 for use as in paragraph (d) of this section.
* * * * *
    (3) Nos. 069043 and 076475 for use as in paragraphs (d)(4)(i)(A),
(d)(4)(i)(B), and (d)(4)(ii) and (iii) of this section.
* * * * *
    (d) * * *
    (4) * * *
    (iii) * * *.
    (C) Limitations. Prepare fresh solution daily as the sole source of
chlortetracycline. Do not use for more than 5 days. For Nos. 066104,
069043, 069254, and 076475: Do not slaughter animals for food within 5
days of treatment. For No. 069254: Do not slaughter animals for food
within 24 hours of treatment. Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
* * * * *

0
10. In Sec.  520.443, revise paragraphs (a), (b), and (d)(3)(ii) to
read as follows:

Sec.  520.443  Chlortetracycline hydrochloride tablets and boluses.

    (a) Specifications. Each tablet contains 25 milligrams (mg)
chlortetracycline hydrochloride; each bolus contains 250 or 500 mg
chlortetracycline hydrochloride.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for
use as in paragraph (d) of this section.
    (1) No. 069043 for use of a 250-mg bolus as in paragraph (d)(1) of
this section.
    (2) No. 016592 for use of a 25-mg tablet as in paragraph (d)(2) of
this section.
    (3) No. 016592 for use of a 500-mg bolus as in paragraph (d)(3) of
this section.
* * * * *
    (d) * * *
    (3) * * *
    (ii) Limitations. Do not use for more than 5 days. Do not
administer within 24 hours of slaughter. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.

Sec.  520.522  [Amended]

0
11. In Sec.  520.522, in paragraph (b)(2), remove ``026637'' and add in
its place ``017033''.

Sec.  520.1196  [Amended]

0
12. In Sec.  520.1196, in paragraph (c)(1)(ii), remove ``ascarids'' and
add in its place ``roundworms''.

0
13. In Sec.  520.1263b, revise paragraphs (b)(1) and (2) to read as
follows:

Sec.  520.1263b  Lincomycin powder.

* * * * *
    (b) * * *
    (1) Nos. 054771 and 061133 for use as in paragraph (d) of this
section.
    (2) Nos. 016592, 054925, and 076475 for use as in paragraphs (d)(1)
and (d)(2) of this section.
* * * * *

0
14. In Sec.  520.2220d, revise paragraph (d)(3) to read as follows:

Sec.  520.2220d  Sulfadimethoxine bolus.

* * * * *
    (d) * * *
    (3) Limitations. Do not administer within 7 days of slaughter. Milk
that has been taken from animals during treatment and 60 hours (five
milkings) after the latest treatment must not be used for food. A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.

0
15. In Sec.  520.2260a, revise paragraph (d)(1)(iii) to read as
follows:

Sec.  520.2260a  Sulfamethazine oblets and boluses.

* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Do not administer for more than 5 consecutive
days. Do not treat cattle within 10 days of slaughter. Do not use in
female dairy cattle 20 months of age or older. Use of sulfamethazine in
this class of cattle may cause milk residues. A withdrawal period has
not been established for this product in preruminating calves. Do not
use in calves to be processed for veal. Do not use in horses intended
for human consumption. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
* * * * *

0
16. In Sec.  520.2640, add paragraph (b)(3) to read as follows:

Sec.  520.2640  Tylosin.

* * * * *
    (b) * * *
    (3) No. 061133 for use of a 100-g container as in paragraphs
(e)(1)(i)(B) and (e)(1)(ii) of this section.
* * * * *

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

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

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

0
18. In Sec.  522.246, revise paragraph (b)(3) to read as follows:

Sec.  522.246  Butorphanol.

* * * * *
    (b) * * *
    (3) Nos. 000061, 017033, 043264, and 059399 for use of the product
described in paragraph (a)(3) of this section as in paragraph (d)(3) of
this section.
* * * * *

Sec.  522.304  [Amended]

0
19. In Sec.  522.304, in paragraph (b), remove ``026637'' and add in
its place ``017033''.

0
20. In Sec.  522.1044, revise paragraphs (d)(2)(i) through (iii),
(d)(3)(i) though (iii), and (d)(4)(i) through (iii) to read as follows:

Sec.  522.1044  Gentamicin.

* * * * *
    (d) * * *
    (2) * * *
    (i) Amount. Administer subcutaneously in the neck 1 mg of
gentamicin per 0.2 mL dose, using the 50- or 100-mg/mL product diluted
with sterile saline to a concentration of 5 mg/mL.
    (ii) Indications for use. As an aid in the prevention of early
mortality in 1- to 3-day old turkey poults due to Arizona

paracolon infections susceptible to gentamicin.
    (iii) Limitations. Injected poults must not be slaughtered for food
for at least 9 weeks after treatment. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
    (3) * * *
    (i) Amount. Administer subcutaneously in the neck 0.2 mg of
gentamicin per 0.2 mL dose, using the 50- or 100-mg/mL product diluted
with sterile saline to a concentration of 1.0 mg/mL.
    (ii) Indications for use. For prevention of early mortality in day-
old chickens caused by Escherichia coli, Salmonella typhimurium, and
Pseudomonas aeruginosa susceptible to gentamicin.
    (iii) Limitations. Injected chicks must not be slaughtered for food
for at least 5 weeks after treatment. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
    (4) * * *
    (i) Amount. Administer 5 mg of gentamicin as a single intramuscular
dose using the 5 mg/mL solution.
    (ii) Indications for use. For treatment of porcine colibacillosis
in piglets up to 3 days old caused by strains of Escherichia coli
sensitive to gentamicin.
    (iii) Limitations. For single intramuscular dose in pigs up to 3
days of age only. Do not slaughter treated animals for food for at
least 40 days following treatment. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
* * * * *

0
21. In Sec.  522.1260, revise paragraph (e)(2)(iii) to read as follows:

Sec.  522.1260  Lincomycin.

* * * * *
    (e) * * *
    (2) * * *
    (iii) Limitations. Do not treat within 48 hours of slaughter. For
No 054771: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.

0
22. In Sec.  522.1660a, revise paragraph (b) and add a sentence to the
end of paragraphs (e)(1)(ii) and (e)(2)(ii) to read as follows:

Sec.  522.1660a  Oxytetracycline solution, 200 milligrams/milliliter.

* * * * *
    (b) Sponsors. See Nos. 000010, 016592, 054771, 055529, 061133, and
069254 in Sec.  510.600(c) of this chapter.
* * * * *
    (e) * * *
    (1) * * *
    (ii) * * * For No. 054771: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
    (2) * * *
    (ii) * * * For No. 054771: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.

0
23. In Sec.  522.1660b, add a sentence to the end of paragraphs
(e)(1)(ii) and (e)(2)(ii) to read as follows:

Sec.  522.1660b  Oxytetracycline solution, 300 milligrams/milliliter.

* * * * *
    (e) * * *
    (1) * * *
    (ii) * * * For No. 055529: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
    (2) * * *
    (ii) * * * For No. 055529: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.

0
24. In Sec.  522.1662, revise paragraphs (j)(3)(i) and (iii) to read as
follows:

Sec.  522.1662  Oxytetracycline.

* * * * *
    (j) * * *
    (3) * * *
    (i) Amount. Administer by intravenous injection 3 to 5 milligrams
per pound of body weight daily. Administer 5 milligrams per pound for
anaplasmosis, severe foot rot, and severe forms of other diseases.
Treatment should be continued 24 to 48 hours following remission of
disease symptoms, but not to exceed a total of 4 consecutive days.
* * * * *
    (iii) Limitations. Not for use in lactating dairy cattle.
Discontinue use at least 19 days prior to slaughter. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.

0
25. In Sec.  522.1696a, revise paragraph (d)(2)(iii) to read as
follows:

Sec.  522.1696a  Penicillin G benzathine and penicillin G procaine
suspension.

* * * * *
    (d) * * *
    (2) * * *
    (iii) Limitations. Not for use within 30 days of slaughter. For No.
016592: A withdrawal period has not been established for this product
in pre-ruminating calves. Do not use in calves to be processed for
veal. For No. 016592: Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

0
26. In Sec.  522.1696b, revise paragraph (d)(2)(iii)(C) to read as
follows:

Sec.  522.1696b  Penicillin G procaine aqueous suspension.

* * * * *
    (d) * * *
    (2) * * *
    (iii) * * *
    (C) For Nos. 054771 and 055529: Federal law restricts this drug to
use by or on the order of a licensed veterinarian.

0
27. Add Sec.  522.1704 to read as follows:

Sec.  522.1704  Pentosan polysulfate sodium.

    (a) Specifications. Each milliliter of solution contains 250
milligrams (mg) of pentosan polysulfate sodium.
    (b) Sponsor. See No. 086073 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer 3 mg per kilogram of
body weight (1.4 mg per pound) by intramuscular injection once weekly
for 4 weeks for a total of four doses.
    (2) Indications for use. For the control of clinical signs
associated with osteoarthritis in horses.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

0
28. In Sec.  522.2470, revise paragraphs (b) introductory text and
(b)(1) to read as follows:

Sec.  522.2470  Tiletamine and zolazepam for injection.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter.
    (1) Nos. 017033 and 054771 for use as in paragraph (c) of this
section.
* * * * *

0
29. In Sec.  522.2471, remove paragraph (d), redesignate paragraph (e)
as paragraph (d), and revise newly redesignated paragraphs (d)(1)(iii)
and (d)(2)(iii).
    The revisions read as follows:

Sec.  522.2471  Tilmicosin.

* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Animals intended for human consumption must not
be slaughtered within 42 days of last treatment. Do not use in
lactating dairy cattle 20 months of age or older. Use of tilmicosin in
this class of cattle may cause milk residues. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
    (2) * * *
    (iii) Limitations. Not for use in lactating ewes producing milk for
human consumption. Animals intended for human consumption must not be
slaughtered within 42 days of last treatment. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.

0
30. In 522.2630, revise paragraph (b)(1) to read as follows:

Sec.  522.2630  Tulathromycin.

* * * * *
    (b) * * *
    (1) Nos. 000061, 013744, 051311, 054771, 055529, 058198, 061133,
and 068504 for use of product described in paragraph (a)(1) as in
paragraphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2) of this
section.
* * * * *

Sec.  522.2640  [Amended]

0
31. In Sec.  522.2640, in paragraph (b)(2), remove ``000010'' and add
in its place ``016592'' and in paragraphs (e)(1)(iii) and (e)(2)(iii),
in the last sentence of each paragraph, remove ``For No. 058198:''.

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

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

    Authority 21 U.S.C. 360b.

0
33. In Sec.  524.970, revise paragraphs (d)(2) and (3) to read as
follows:

Sec.  524.970  Flunixin.

* * * * *
    (d) * * *
    (2) Indications for use. For the control of pyrexia associated with
bovine respiratory disease and acute bovine mastitis, and the control
of pain associated with foot rot in beef cattle 2 months of age and
older and dairy cattle.
    (3) Limitations. Not for use in beef and dairy bulls intended for
breeding over 1 year of age. Milk that has been taken during treatment
and for 48 hours after treatment must not be used for human
consumption. Cattle must not be slaughtered for human consumption
within 8 days of treatment. Not for use in replacement dairy heifers 20
months of age or older or dry dairy cows; use in these cattle may cause
drug residues in calves born to these cows or heifers. Not for use in
beef calves less than 2 months of age, dairy calves, and veal calves. A
withdrawal period has not been established for this product in pre-
ruminating calves. Approved only as a single topical dose in cattle.
Repeated treatments may result in violative residues in milk or in
edible tissues. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.

Sec.  524.1044c  [Amended]

0
34. In Sec.  524.1044c, in paragraph (b), remove ``026637'' and add in
its place ``017033''.

0
35. In Sec.  524.1044f, revise paragraph (b) to read as follows:

Sec.  524.1044f  Gentamicin and betamethasone spray.

* * * * *
    (b) Sponsors. See Nos. 000061, 017033, 054925, 058005, and 058829
in Sec.  510.600(c) of this chapter.
* * * * *

0
36. In Sec.  524.1448, revise paragraph (c)(2) to read as follows:

Sec.  524.1448  Mirtazapine transdermal ointment.

* * * * *
    (c) * * *
    (2) Indications for use. For body weight gain in cats with a
history of weight loss.
* * * * *

Sec.  524.1484g  [Amended]

0
37. In Sec.  524.1484g, in paragraph (b), remove ``026637'' and add in
its place ``017033''.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
39. In Sec.  526.363, revise paragraph (d)(3) to read as follows:

Sec.  526.363  Cephapirin benzathine.

* * * * *
    (d) * * *
    (3) Limitations. For use in dry cows only. Not to be used within 30
days of calving. Milk from treated cows must not be used for food
during the first 72 hours after calving. Animals infused with this
product must not be slaughtered for food until 42 days after the latest
infusion. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.

0
40. In Sec.  526.365, revise paragraph (d)(3) to read as follows:

Sec.  526.365  Cephapirin sodium.

* * * * *
    (d) * * *
    (3) Limitations. Milk that has been taken from animals during
treatment and for 96 hours after the last treatment must not be used
for food. Treated animals must not be slaughtered for food until 4 days
after the last treatment. 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
41. The authority citation for part 529 continues to read as follows:

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

0
42. In Sec.  529.1044b, add a sentence to the end of paragraph (c)(3)
to read as follows:

Sec.  529.1044b  Gentamicin solution for dipping eggs.

* * * * *
    (c) * * *
    (3) * * * For No. 000061: Federal law restricts this drug to use by
or on the order of a licensed veterinarian.

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

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

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

0
44. In Sec.  556.222, revise paragraphs (b)(1)(i) and (c) to read as
follows:

Sec.  556.222  Doramectin.

* * * * *
    (b) * * *
    (1) * * *
    (i) Liver (target tissue): 300 ppb.
* * * * *
    (c) Related conditions of use. See Sec. Sec.  522.770, 522.772, and
524.770 of this chapter.

0
45. In Sec.  556.500, revise paragraph (c) to read as follows:

Sec.  556.500  Oxytetracycline.

* * * * *
    (c) Related conditions of use. See Sec. Sec.  520.1660a, 520.1660c,
520.1660d, 522.1660a, 522.1660b, 522.1662, 522.1664, 529.1660, 558.450,
and 558.455 of this chapter.

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

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

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

0
47. In Sec.  558.76, redesignate paragraph (d)(1)(iv) as paragraph
(d)(1)(v) and add new paragraph (d)(1)(iv) to read as follows:

Sec.  558.76  Bacitracin methylenedisalicylate.

* * * * *
    (d) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
  Bacitracin in grams per ton          Indications for use                  Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(iv) 50........................  Broiler and replacement          Feed as the sole ration for 28          069254
                                  chickens: For the prevention     to 35 days, starting from the
                                  of mortality caused by           time chicks are placed for
                                  necrotic enteritis associated    brooding.
                                  with Clostridium perfringens.

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

* * * * *

0
48. In Sec.  558.355, revise paragraph (d)(8)(vi) to read as follows:

Sec.  558.355  Monensin.

* * * * *
    (d) * * *
    (8) * * *
    (vi) Not for broiler breeder replacement chickens.
* * * * *

0
49. In Sec.  558.364:
0
a. Revise paragraphs (d)(1)(ii) and (iii);
0
b. Redesignate paragraphs (d)(1)(iv) and (v) as paragraphs (d)(1)(vi)
and (vii); and
0
c. Add new paragraphs (d)(1)(iv) and (v).
    The revisions and additions read as follows:

Sec.  558.364  Narasin and nicarbazin.

* * * * *
    (d) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
 Narasin and nicarbazin grams/    Combination in
              ton                   grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(ii) 27 to 45 of each drug....  Bacitracin         Broiler chickens: For   Feed continuously as           058198
                                 methylenedisalic   the prevention of       the sole ration. Do
                                 ylate, 4 to 50.    coccidiosis caused by   not feed to laying
                                                    Eimeria necatrix, E.    hens. Do not allow
                                                    tenella, E.             adult turkeys,
                                                    acervulina, E.          horses, or other
                                                    brunetti, E. mivati,    equines access to
                                                    and E. maxima, and      formulations
                                                    for increased rate of   containing narasin.
                                                    weight gain and         Ingestion of narasin
                                                    improved feed           by these species has
                                                    efficiency.             been fatal. Withdraw
                                                                            5 days before
                                                                            slaughter.
                                                                            Bacitracin
                                                                            methylenedisalicylat
                                                                            e as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(iii) 27 to 45 of each drug...  Bacitracin         Broiler chickens: For   Feed as the sole               069254
                                 methylenedisalic   the prevention of       ration throughout
                                 ylate, 4 to 50.    coccidiosis caused by   the feeding period.
                                                    Eimeria necatrix, E.    For broiler chickens
                                                    tenella, E.             only. Do not feed to
                                                    acervulina, E.          laying hens. Do not
                                                    brunetti, E. mivati,    allow adult turkeys,
                                                    and E. maxima, and      horses, or other
                                                    for increased rate of   equines access to
                                                    weight gain and         formulations
                                                    improved feed           containing narasin.
                                                    efficiency.             Ingestion of narasin
                                                                            by these species has
                                                                            been fatal.
                                                                            Bacitracin
                                                                            methylenedisalicylat
                                                                            e as provided by No.
                                                                            069254 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(iv) 27 to 45 of each drug....  Bacitracin         Broiler chickens: For   Feed continuously as           054771
                                 methylenedisalic   the prevention of       the sole ration. Do
                                 ylate, 50.         coccidiosis caused by   not feed to laying
                                                    Eimeria tenella, E.     hens. Do not allow
                                                    necatrix, E.            adult turkeys,
                                                    acervulina, E.          horses, or other
                                                    maxima, E. brunetti,    equines access to
                                                    and E. mivati, and as   formulations
                                                    an aid in the           containing narasin.
                                                    prevention of           Ingestion of narasin
                                                    necrotic enteritis      by these species has
                                                    caused or complicated   been fatal. Withdraw
                                                    by Clostridium spp.     5 days before
                                                    or other organisms      slaughter.
                                                    susceptible to          Bacitracin
                                                    bacitracin.             methylenedisalicylat
                                                                            e as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(v) 27 to 45 of each drug.....  Bacitracin         Broiler chickens: For   Feed as the sole               069254
                                 methylenedisalic   the prevention of       ration for 28 to 35
                                 ylate, 50.         coccidiosis caused by   days, starting from
                                                    Eimeria necatrix, E.    the time chicks are
                                                    tenella, E.             placed for brooding.
                                                    acervulina, E.          For broiler chickens
                                                    brunetti, E. mivati,    only. Do not feed to
                                                    and E. maxima, and      laying hens. Do not
                                                    for the prevention of   allow adult turkeys,
                                                    mortality caused by     horses, or other
                                                    necrotic enteritis      equines access to
                                                    associated with         formulations
                                                    Clostridium             containing narasin.
                                                    perfringens.            Ingestion of narasin
                                                                            by these species has
                                                                            been fatal.
                                                                            Bacitracin
                                                                            methylenedisalicylat
                                                                            e as provided by No.
                                                                            069254 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.

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

* * * * *

    Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05465 Filed 3-17-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 200 (Wednesday, October 20, 2021)]
[Notices]
[Pages 58145-58146]
[FR Doc No: 2021-22821]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2021-0091]

Senior Executive Service Performance Review Boards Membership

AGENCY: Office of the Secretary, Department of Transportation (DOT).

ACTION: Notice of Performance Review Board (PRB) appointments.

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

SUMMARY: DOT published the names of the persons selected to serve on
Departmental PRBs.

FOR FURTHER INFORMATION CONTACT: Anne B. Audet, Director, Departmental
Office of Human Resource Management<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The persons named below may be selected to
serve on one or more Departmental PRBs.

(Authority: 5 U.S.C. 4314(c)(4))

    Issued in Washington, DC, on September 14, 2021.
Keith E. Washington,
Deputy Assistant Secretary for Administration.

DEPARTMENT OF TRANSPORTATION

Federal Highway Administration

ALONZI, ACHILLE
ARNOLD, ROBERT E
BAKER, SHANA V
BEZIO, BRIAN R
BIONDI, EMILY CHRISTINE
BRIGGS, VALERIE ANNETTE
BURROWS, SHAY K
CHRISTIAN, JAMES C
CRONIN, BRIAN P
CURTIS, STEPHANIE
EVANS, MONIQUE REDWINE
EVERETT, THOMAS D
FINFROCK, ARLAN E JR
FLEURY, NICOLLE M
FOUCH, BRIAN J
GIGLIOTTI, DANA
GRIFFITH, MICHAEL S
HARTMANN, JOSEPH L
HESS, TIMOTHY G.
HUGHES, CAITLIN GWYNNE
JENSEN, GARY ALAN
KALLA, HARI
KEHRLI, MARK R
KNOPP, MARTIN C
LEONARD, KENNETH
LEWIS, DAVID A
LUCERO, AMY C
MAMMANO, VINCENT P
MARQUIS, RICHARD J
MCLAURY, KEVIN L
OSBORN, PETER W
PETTY, KENNETH II
POLLACK, STEPHANIE LYNN
REGAL, GERALDINE K
RICHARDSON, CHRISTOPHER S
RICHTER, CHERYL ALLEN
RICO, IRENE
ROGERS, ANDREW CHARLES
RUSNAK, ALLISON B
SCHAFTLEIN, SHARI M
SHAFFER, RHONDA C
SHEPHERD, GLORIA MORGAN
SOSA, MAYELA
STEPHANOS, PETER J
TURNER, DERRELL E
WALKER, CHERYL J
WINTER, DAVID R

WRIGHT, LESLIE JANICE

Federal Motor Carrier Safety Administration

ADAMS, EARL STANLEY JR
DELORENZO, JOSEPH P
FROMM, CHARLES J
GRAYDON, AMY HEATHER
HERNANDEZ, SCOTT
HUG, CARRIE A
JONES, DARIN G
JOSHI, MEERA CATHERINE
KEANE, THOMAS P
KELLY, TAFT D
MINOR, LARRY W
PIDUGU, PAVANKUMAR
RIDDLE, KENNETH H.
RUBAN, DARRELL L
SCHREIBMAN, JACK L
SENTEF, JOSEPH
VAN STEENBURG, JOHN W

Federal Railroad Administration

ALEXY, JOHN KARL
ALLAHYAR, MARYAM
BOSE, AMITABHA
DYER, WILLIAM PATRICK
HAYWARD-WILLIAMS, CAROLYN
JORTLAND, BRETT ANDREW
KING, CHARLES PAT
KOUL, NEERAJ
LESTINGI, MICHAEL W.
LONG, MICHAEL T
NISSENBAUM, PAUL
PATTERSON, MARK A
RENNERT, JAMIE P.
REYES-ALICEA, REBECCA
RIGGS, TAMELA LYNN

Federal Transit Administration

AHMAD, MOKHTEE
ALLEN, REGINALD E
BROOKINS, KELLEY
BUTLER, PETER S
DALTON-KUMINS, SELENE FAE
GARCIA CREWS, THERESA
GEHRKE, LINDA M
GOODMAN, STEPHEN C
IYER, SUBASH SUBRAMANIAN
JAMES, FELICIA LANISE
LYSSY, GAIL C
NIFOSI, DANA C.
ROBINSON, BRUCE A
TAYLOR, YVETTE G
TELLIS, RAYMOND S
TERWILLIGER, CINDY E
WELBES, MATTHEW J

Great Lakes St. Lawrence Seaway Development Corporation

MIDDLEBROOK, CRAIG H
O'MALLEY, KEVIN P

Maritime Administration

BALLARD, JOHN R
BECKETT, COREY ANDREW
BROHL, HELEN A
BUONO, JOACHIM
CARTER, MICHAEL C
DAVIS, DELIA P
DUNLAP, SUSAN LYNN
FISHER, ANTHONY JR
HARRINGTON, DOUGLAS M
KUMAR, SHASHI N
LESSLEY, LUCINDA DAVIS
PAAPE, WILLIAM
PIXA, RAND R.
TOKARSKI, KEVIN M

National Highway Traffic Safety Administration

BAUMANN, ROLAND T III
BLINCOE, LAWRENCE J
CARLSON, ANN ELIZABETH
CHEN, CHOU-LIN
CLIFF, STEVEN SCOTT
COLLINS, ANNE L
DANIELSON, JACK H.
DOHERTY, JANE H
DOLAS, RAJEEV K
DONALDSON, K JOHN
HATIPOGLU, CEM
HINES, DAVID M
JOHNSON, TIM J
KOLLY, JOSEPH M
KOLODZIEJ, KERRY E
MARSHALL, JOHN W
MATHEKE, OTTO G III
PARKER, CYNTHIA D
PFISTER, JAMIE DURHAM
POSTEN, RAYMOND R
RIDELLA, STEPHEN A
RITTER, ROBERT G
SRINIVASAN, NANDA N
SUMMERS, LORI K
VALLESE, JULIETTE M.

Office of the Secretary of Transportation

ABRAHAM, JULIE
ALBRIGHT, JACK G
AUDET, ANNE H
AUGUSTINE, JOHN E
AYLWARD, ANNE D
BOHNERT, ROGER V
CALLENDER, DUANE A
CARLSON, TERENCE W
CHAVEZ, RICHARD M.
CHULUMOVICH, MADELINE M
COES, CHRISTOPHER ALEXAND
COGGINS, COLLEEN P
COHEN, DANIEL
COHN HUTCHESON, ROBIN M
CONNORS, SUSAN M
DOUGHERTY, BARBARA KAYE
FARAJIAN, MORTEZA
FLEMING, GREGG G
FUNK, JENNIFER S
GEIER, PAUL M
HAMPSHIRE, ROBERT CORNELI
HENDERSON, MAURICE ALEXAN
HERLIHY, THOMAS W
HOMAN, TODD M
HORN, DONALD H
HU, PATRICIA S.
HURDLE, LANA T
HUYNH, JULI C
IRVINE, PETER D
JACKSON, RONALD A
KALETA, JUDITH S
KING, DANIEL E.
LAWRENCE, CHRISTINE A
LEFEVRE, MARIA S.
LOHRENZ, MAURA C
MARCHESE, APRIL LYNN
MARION, IRENE BIANCA
MARTIN, HAROLD W III
MCCARTNEY, ERIN P
MCNAMARA, PHILIP ADAM
MORGAN, DANIEL S.
O'BERRY, DONNA
ORNDORFF, ANDREW R
PAIEWONSKY, LUISA M
PETROSINOWOOLVERTON, MARI
PETSONK, CAROL ANNETTE
POPKIN, STEPHEN M
PUTNAM, JOHN EDWARD
REAMY, LYNDA TRAN
RUIZ, KRISTIN RAE
SCHILLER, LAURA ELIZABETH
SCHMITT, ROLF R
SHAPIRO, MICHAEL PARIS
SHEIKH IBRAHIM, FIRAS
SHULMAN, SOPHIE MIKHAL
SIMONS, DANI LYNN
SIMPSON, JOAN
SMITH, WILLIE H
SPRAGUE, MARY G.
SZABAT, JOEL M
SZAKAL, KEITH J
SZATMARY, RONALD ALLEN JR
TAYLOR, BENJAMIN J
TIMOTHY, DARREN P
WASHINGTON, KEITH E
WASSMER, VICTORIA BAECHER
WISHNIA, ANDREW JAY
WORKIE, BLANE A
ZIFF, LAURA M

Pipeline and Hazardous Materials Safety Administration

BORENER, SHERRY S
BROWN, TRISTAN HILTON
DAUGHERTY, LINDA
DAVIS, CAREY THOMAS
FARLEY, AUDREY L.
GATTI, JONATHAN D
GORDON, STEPHEN N JR
MAYBERRY, ALAN K
MCMILLAN, HOWARD W
QUADE, WILLIAM A III
SCHOONOVER, WILLIAM S
TAHAMTANI, MASSOUD
TSAGANOS, VASILIKI B

[FR Doc. 2021-22821 Filed 10-19-21; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 87, Number 221 (Thursday, November 17, 2022)]
[Notices]
[Pages 69017-69018]
[FR Doc No: 2022-25027]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-401-000]

CED Timberland Solar, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
CED Timberland Solar, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is November 30, 2022.
    The Commission encourages electronic submission of protests and

interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: November 10, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-25027 Filed 11-16-22; 8:45 am]
BILLING CODE 6717-01-P


 [Federal Register Volume 77, Number 26 (Wednesday, February 8, 2012)] [Notices] [Page 6619] [FR Doc No: C1-2012-1583]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66208; File No. SR-Phlx-2012-06]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of  Filing and Immediate Effectiveness of Proposed Rule Change Amending the  Real-Time Risk Management Fee and Other Clarifying Amendments

January 20, 2012.

Correction

    In notice document 2012-1583 appearing on pages 4077-4079 in the  issue of January 26, 2012 make the following correction:     On page 4079, in the first column, in the last full paragraph, in  the last sentence, ``February 13, 2012'', should read ``February 16,  2012.''

[FR Doc. C1-2012-1583 Filed 2-7-12; 8:45 am] BILLING CODE 1505-01-D


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Tuesday, August 1, 2023 11:50 AM
To:
STARKWEATHER, DIANA M<EMAIL_ADDRESS>Cc:
French, Chuck<EMAIL_ADDRESS>Hansen, Amanda<EMAIL_ADDRESS>Boaggio, Katie<EMAIL_ADDRESS>Subject:
FW: SIGNED: Proposed Amendments to Air Toxics Standards for Coke Ovens and Coke Oven Batteries

Hello Diana  -  I know Katie is out until next Monday from the response I received after sending this email below. Can you acknowledge receipt of this email (below) for SunCoke? Thanks.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: Jones, DonnaLee
Sent: Tuesday, August 1, 2023 11:38 AM
To<EMAIL_ADDRESS>Cc: French, Chuck<EMAIL_ADDRESS>Hansen, Amanda<EMAIL_ADDRESS>Boaggio, Katie<EMAIL_ADDRESS>Subject: SIGNED: Proposed Amendments to Air Toxics Standards for Coke Ovens and Coke Oven Batteries

Hello Katie  -  Good morning!

Last night, the U.S. Environmental Protection Agency (EPA) proposed to update and strengthen emission standards for hazardous air pollutants such as benzene, mercury, lead and arsenic that are emitted by coke oven facilities. These proposed amendments would further reduce emissions of hazardous air pollutants, also known as HAP, and improve accountability and compliance assurance at coke oven facilities.

The proposed amendments would fulfill EPA's responsibility under the Clean Air Act to periodically review emission standards to reflect developments in pollution control technologies and techniques, and to establish standards for all types of hazardous air pollutants emitted by regulated facilities.  If finalized, the proposal would establish more protective standards for HAP leaks from doors and other sources at coke oven batteries; establish a fenceline monitoring requirement to ensure that coke oven batteries regularly monitor benzene levels near the facility and take appropriate corrective action if these levels exceed a particular threshold; and establish standards for currently unregulated pollutants, such as mercury and non-mercury metals, emitted by coke ovens.

EPA will be taking public comment on the proposed amendments for 45 days after it is published in the Federal Register. Interested parties can download a copy of the NESHAP for Coke Ovens Pushing, Quenching, and Battery Stacks proposed rule and fact sheet from EPA's website at the following address: https://www.epa.gov/stationary-sources-air-pollution/coke-ovens-pushing-quenching-and-battery-stacks-national-emission

A copy of the proposed rule and fact sheet for the Coke Oven Batteries NESHAP can be found at: https://www.epa.gov/stationary-sources-air-pollution/coke-ovens-batteries-national-emissions-standards-hazardous-air

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.


[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Rules and Regulations]
[Page 55572]
[FR Doc No: 2023-17554]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2023-0598]

Special Local Regulations; Marine Events Within the Fifth Coast
Guard District--Atlantic City, NJ

AGENCY: Coast Guard, DHS.

ACTION: Notification of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the special local regulation for
the Thunder Over the Boardwalk Air Show August 14, 15, and 16, 2023, to
provide for the safety of life on navigable waterways during this
event. Our regulation for marine events within the Fifth Coast Guard
District identifies the regulated area for this event in Atlantic City,
NJ. During the enforcement periods, the operator of any vessel in the
regulated area must comply with directions from the Patrol Commander or
any Official Patrol displaying a Coast Guard ensign.

DATES: The regulations in 33 CFR 100.501 will be enforced for the
Thunder Over the Boardwalk Air Show event listed in table 1 to
paragraph (i)(1) to Sec.  100.501 from 10 a.m. through 5 p.m. on August
14-16, 2023, to provide for the safety of life on navigable waterways
during this event.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, you may call or email Petty Officer Christopher
Payne, U.S. Coast Guard, Sector Delaware Bay, Waterways Management
Division, telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulations in 33 CFR 100.501 for the Thunder Over the Boardwalk
Airshow regulated area from 12 p.m. through 3 p.m. on August 14, 2023,
and from 9 a.m. through 5 p.m. August 15 and 16, 2023. This action is
being taken to provide for the safety of life on navigable waterways
during this 3-day event. Our regulation for marine events within the
Fifth Coast Guard District, Sec.  100.501, specifies the location of
the regulated area for the Thunder Over the Boardwalk Airshow, which
encompasses waters of the North Atlantic Ocean, adjacent to Atlantic
City, New Jersey, bounded by a line drawn between the following points:
From a point along the shoreline at latitude 39[deg]21'31'' N,
longitude 074[deg]25'04'' W, thence southeasterly to latitude
39[deg]21'08'' N, longitude 074[deg]24'48'' W, thence southwesterly to
latitude 39[deg]20'16'' N, longitude 074[deg]27'17'' W, thence
northwesterly to a point along the shoreline at latitude 39[deg]20'44''
N, longitude 074[deg]27'31'' W, thence northeasterly along the
shoreline to latitude 39[deg]21'31'' N, longitude 074[deg]25'04'' W.
    During the enforcement periods, as reflected in Sec.  100.501(g),
the Coast Guard will announce details concerning the event in the Local
Notices to Mariners and by Broadcast Notice to Mariners over VHF-FM
marine band radio. If you are the operator of a vessel in the regulated
area you must comply with directions from the Patrol Commander or any
Official Patrol displaying a Coast Guard ensign.

    Dated: August 10, 2023.
Kate F. Higgins-Bloom,
Captain, U.S. Coast Guard, Captain of the Port, Delaware Bay.
[FR Doc. 2023-17554 Filed 8-15-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: October 25, 2010 (Volume 75, Number 205)]
[Notices]
[Page 65502]
[DOCID:fr25oc10-83]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1930-DR; Docket ID FEMA-2010-0002]

Iowa; Amendment No. 11 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Iowa (FEMA-1930-DR), dated July 29, 2010, and related
determinations.

DATES: Effective Date: October 15, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Iowa is hereby amended to include the following areas
among those areas determined to have been adversely affected by the
event declared a major disaster by the President in his declaration of
July 29, 2010.

    Boone, Calhoun, and Shelby Counties for Individual Assistance
(already designated for Public Assistance).
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-26843 Filed 10-22-10; 8:45 am]
BILLING CODE 9111-23-P