[Federal Register Volume 85, Number 145 (Tuesday, July 28, 2020)]
[Rules and Regulations]
[Pages 45306-45311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15760]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

[Docket No. FDA-2020-N-0002]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs) and abbreviated new animal drug 
applications (ANADAs) during January, February, and March 2020. FDA is 
informing the public of the availability of summaries of the basis of 
approval and of environmental review documents, where applicable. The 
animal drug regulations are also being amended to make technical 
amendments to improve the accuracy of the regulations.

DATES: This rule is effective July 28, 2020.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Approvals

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during January, February, and March 2020, 
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 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. 240-402-7500. 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 and ANADAs Approved During January, February, and March 2020
--------------------------------------------------------------------------------------------------------------------------------------------------------
     Approval date        File No.        Sponsor          Product name           Species          Effect of the action          Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 28, 2020.......    141-466  Elanco US Inc.,     Narasin and         Chickens...........  Supplemental approval    FOI Summary.
                                     2500 Innovation     nicarbazin and                           of an increased age
                                     Way, Greenfield,    avilamycin Type C                        restriction and
                                     IN 46140.           medicated broiler                        reduced withdrawal
                                                         feeds.                                   period in the use of
                                                                                                  MAXIBAN (narasin and
                                                                                                  nicarbazin) Type A
                                                                                                  medicated article)
                                                                                                  with INTEPRITY
                                                                                                  (avilamycin) Type A
                                                                                                  medicated articles in
                                                                                                  the manufacture of
                                                                                                  Type C medicated
                                                                                                  broiler feeds.
February 7, 2020.......    200-614  Akorn Animal        Pentobarbital       Dogs...............  Original approval as a   FOI Summary.
                                     Health, Inc.,       Sodium and                               generic copy of NADA
                                     1925 West Field     Phenytoin Sodium                         119-807.
                                     Ct., Suite 300,     Injectable
                                     Lake Forest, IL     Solution.
                                     60045.
February 27, 2020......    141-521  Zoetis Inc., 333    SIMPARICA TRIO      Dogs...............  Original approval for    FOI Summary.
                                     Portage St.,        (sarolaner,                              the prevention of
                                     Kalamazoo, MI       moxidectin, and                          heartworm disease;
                                     49007.              pyrantel chewable                        kills adult fleas and
                                                         tablets) Chewable                        is indicated for the
                                                         Tablet.                                  treatment and
                                                                                                  prevention of flea
                                                                                                  infestations, the
                                                                                                  treatment and control
                                                                                                  of tick infestations,
                                                                                                  and the treatment and
                                                                                                  control of roundworm
                                                                                                  and adult hookworm
                                                                                                  infections for one
                                                                                                  month.
March 10, 2020.........    200-670  Chanelle            SENERGY             Dogs and cats......  Original approval as a   FOI Summary.
                                     Pharmaceuticals     (selamectin)                             generic copy of NADA
                                     Manufacturing       Topical Solution.                        141-152.
                                     Ltd., Loughrea,
                                     County Galway,
                                     H62 FH90, Ireland.

[[Page 45307]]

 
March 23, 2020.........    200-586  Dechra Veterinary   MARBOQUIN           Dogs...............  Original approval as a   FOI Summary.
                                     Products, LLC,      (marbofloxacin)                          generic copy of NADA
                                     7015 College        Tablets.                                 141-151.
                                     Blvd., Suite 525,
                                     Overland Park, KS
                                     66211.
March 27, 2020.........    141-322  Zoetis Inc., 333    IMPROVEST           Swine..............  Supplemental approval    FOI Summary EA/FONSI.
                                     Portage St.,        (gonadotropin                            for the temporary
                                     Kalamazoo, MI       release factor                           suppression of estrus
                                     49007.              analog-diphtheria                        in gilts intended for
                                                         toxoid conjugate)                        slaughter.
                                                         Injectable
                                                         Solution.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Withdrawals of Approval

    Hikma International Pharmaceuticals LLC, P.O. Box 182400, Bayader 
Wadi Seer, Amman, Jordan 11118 has requested that FDA withdraw approval 
of ANADA 200-323 for a 1-gram phenylbutazone bolus because the product 
is no longer manufactured or marketed. Following this withdrawal of 
approval, Hikma International Pharmaceuticals LLC is no longer the 
sponsor of an approved application. As provided in the regulatory text 
of this document, the animal drug regulations are amended to reflect 
this action. Elsewhere in this issue of the Federal Register, FDA gave 
notice that approval of ANADA 200-323, and all supplements and 
amendments thereto, is withdrawn.

III. Changes of Sponsor

    Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, 
Overland Park, KS 66211 has informed FDA that it has transferred 
ownership of, and all rights and interest in, approved NADA 008-760 for 
ADRENOMONE (corticotropin) Injection to Dechra, Ltd., Snaygill 
Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, 
United Kingdom.
    Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 200, 
Burlingame, CA 94010 has informed FDA that it has transferred ownership 
of, and all rights and interest in, approved NADA 141-481 for MIRATAZ 
(mirtazapine) Transdermal Ointment to Dechra, Ltd., Snaygill Industrial 
Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United 
Kingdom.
    Accordingly, we are amending the regulations to reflect these 
changes.

IV. Technical Amendments

    FDA is revising sections for efrotomycin, iodinated casein, 
maduramicin, mibolerone, nystatin, and poloxalene in 21 CFR part 558 to 
reflect a tabular format. The section for tiamulin oral dosage forms in 
21 CFR part 520 is being revised to correct ownership of certain 
products. These amendments will improve the readability and accuracy of 
the animal drug regulations.

V. Legal Authority

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

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520, 522, and 524

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
510, 520, 522, 524, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

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

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


Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry 
for ``Hikma International Pharmaceuticals LLC''; and in the table in 
paragraph (c)(2), remove the entry for ``059115''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec.  520.1310  [Amended]

0
4. In Sec.  520.1310, in paragraph (b), remove ``No. 054771'' and in 
its place add '' Nos. 026637 and 054771''.


Sec.  520.1720a  [Amended]

0
5. In Sec.  520.1720a, remove paragraphs (b)(4) and (5) and redesignate 
paragraph (b)(6) as paragraph (b)(4).

0
6. Add Sec.  520.2090 to read as follows:


Sec.  520.2090  Sarolaner, moxidectin, and pyrantel.

    (a) Specifications. Each chewable tablet contains:
    (1) 3.0 mg sarolaner, 0.06 mg moxidectin, and 12.5 milligrams (mg) 
pyrantel (as pamoate salt);
    (2) 6.0 mg sarolaner, 0.12 mg moxidectin, and 25.0 mg pyrantel (as 
pamoate salt);

[[Page 45308]]

    (3) 12.0 mg sarolaner, 0.24 mg moxidectin, and 50.0 mg pyrantel (as 
pamoate salt);
    (4) 24.0 mg sarolaner, 0.48 mg moxidectin, and 100 mg pyrantel (as 
pamoate salt);
    (5) 48.0 mg sarolaner, 0.96 mg moxidectin, and 200 mg pyrantel (as 
pamoate salt); or
    (6) 72.0 mg sarolaner, 1.44 mg moxidectin, and 300 mg pyrantel (as 
pamoate salt).
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally, once 
a month, at the recommended minimum dose of 0.54 mg/lb (1.2 mg/kg) 
sarolaner, 0.011 mg/lb (24 [mu]g/kg) moxidectin, and 2.27 mg/lb (5 mg/
kg) pyrantel (as pamoate salt).
    (2) Indications for use. Prevents heartworm disease caused by 
Dirofilaria immitis, kills adult fleas (Ctenocephalides felis) and is 
indicated for the treatment and prevention of flea infestations, the 
treatment and control of tick infestations with Amblyomma americanum 
(lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor 
variabilis (American dog tick), Ixodes scapularis (black-legged tick), 
and Rhipicephalus sanguineus (brown dog tick), and the treatment and 
control of roundworm (immature adult and adult Toxocara canis and adult 
Toxascaris leonina) and adult hookworm (Ancylostoma caninum and 
Uncinaria stenocephala) infections for 1 month in dogs and puppies 8 
weeks of age and older, and weighing 2.8 pounds or greater.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  520.2455  [Amended]

0
7. In Sec.  520.2455, in paragraph (b)(2), remove ``paragraph (a)(1)'' 
and in its place add ``paragraphs (a)(1) and (a)(3)''.

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

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

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


Sec.  522.480  [Amended]

0
9. In Sec.  522.480, in paragraph (b)(2), remove ``026637'' and in its 
place add ``043264''.

0
10. In Sec.  522.1083, revise paragraphs (a) and (c) to read as 
follows:


Sec.  522.1083  Gonadotropin releasing factor analog-diphtheria toxoid 
conjugate.

    (a) Specifications. Each milliliter (mL) of solution contains 0.2 
milligrams (mg) gonadotropin releasing factor analog-diphtheria toxoid 
conjugate.
* * * * *
    (c) Conditions of use in swine--(1) Amount. Each intact male pig or 
gilt should receive two 2-mL (0.4 mg) doses by subcutaneous injection. 
Administer the first dose no earlier than 9 weeks of age. Administer 
the second dose at least 4 weeks after the first dose.
    (2) Indications for use. (i) Intact male pigs intended for 
slaughter: For the temporary immunological castration (suppression of 
testicular function) and reduction of boar taint.
    (ii) Gilts intended for slaughter: For the temporary suppression of 
estrus.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. For reduction of boar taint, 
intact male pigs should be slaughtered no earlier than 3 weeks and no 
later than 10 weeks after the second dose.


Sec.  522.1697  [Amended]

0
11. In Sec.  522.1697, in paragraph (b), remove ``000061, 051311, and 
054925'' and in its place add ``000061, 051311, 054925, and 059399''.

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

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

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


Sec.  524.1448  [Amended]

0
13. In Sec.  524.1448, in paragraph (b), remove ``086078'' and in its 
place add ``043264''.

0
14. In Sec.  524.1484b, revise the section heading and paragraph (a) to 
read as follows:


Sec.  524.1484b  Neomycin, isoflupredone, and tetracaine powder.

    (a) Specifications. Each 15-gram insufflator bottle contains 5 
milligrams (mg) neomycin sulfate (equivalent to 3.5 mg neomycin base), 
1 mg isoflupredone acetate, and 5 mg tetracaine hydrochloride in a 
powder base.
* * * * *


Sec.  524.2098  [Amended]

0
15. In Sec.  524.2098, in paragraph (b), remove ``Nos. 054771 and 
055529'' and in its place add ``Nos. 054771, 055529, and 061651''.

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

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

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


0
17. In Sec.  558.68, revise paragraph (e)(1)(iv) to read as follows:


Sec.  558.68  Avilamycin.

* * * * *
    (e) * * *
    (1) * * *

[[Page 45309]]



----------------------------------------------------------------------------------------------------------------
                                 Combination in
   Avilamycin in grams/ton         grams/ton          Indications for use          Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iv) 13.6 to 40.9...........  Narasin, 27 to 45    Broiler chickens: For     Feed as the sole ration      058198
                               plus nicarbazin,     the prevention of         for 21 consecutive
                               27 to 45.            mortality caused by       days to chickens that
                                                    necrotic enteritis        are at risk of
                                                    associated with           developing, but not
                                                    Clostridium               yet showing clinical
                                                    perfringens; and for      signs of, necrotic
                                                    the prevention of         enteritis associated
                                                    coccidiosis caused by     with Clostridium
                                                    Eimeria necatrix, E.      perfringens.
                                                    tenella, E. acervulina,   Avilamycin has not
                                                    E. brunetti, E. mivati,   been demonstrated to
                                                    and E. maxima.            be effective in
                                                                              broiler chickens
                                                                              showing clinical signs
                                                                              of necrotic enteritis
                                                                              prior to the start of
                                                                              medication. To assure
                                                                              responsible
                                                                              antimicrobial drug use
                                                                              in broiler chickens,
                                                                              treatment
                                                                              administration must
                                                                              begin on or before 18
                                                                              days of age. The
                                                                              safety of avilamycin
                                                                              has not been
                                                                              established in
                                                                              chickens intended for
                                                                              breeding purposes. Do
                                                                              not allow adult
                                                                              turkeys, horses, or
                                                                              other equines access
                                                                              to narasin
                                                                              formulations.
                                                                              Ingestion of narasin
                                                                              by these species has
                                                                              been fatal. Do not
                                                                              feed to chickens
                                                                              producing eggs for
                                                                              human consumption.
                                                                              Narasin and nicarbazin
                                                                              as provided by No.
                                                                              058198 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
18. In Sec.  558.235, revise paragraph (d) to read as follows:


Sec.  558.235  Efrotomycin.

* * * * *
    (d) Conditions of use in swine--

----------------------------------------------------------------------------------------------------------------
     Efrotomycin  in grams/ton             Indications for use                  Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 3.6............................  Swine: For improved feed         Feed continuously as sole           000010
                                      efficiency.                      ration. Not to be used in
                                                                       swine weighing more than 250
                                                                       pounds.
(2) 3.6 to 14.5....................  Swine: For increased rate of     Feed continuously as sole           000010
                                      weight gain.                     ration. Not to be used in
                                                                       swine weighing more than 250
                                                                       pounds.
----------------------------------------------------------------------------------------------------------------


0
19. Revise Sec.  558.295 to read as follows:


Sec.  558.295  Iodinated casein.

    (a) Type A medicated articles containing grams iodinated casein per 
pound.
    (b) Sponsor. See No. 017762 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Ducks--

----------------------------------------------------------------------------------------------------------------
        Amount in grams/ton                Indications for use                  Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 100 to 200.....................  Growing ducks: For increased     ..............................      017762
                                      rate of weight gain.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------


[[Page 45310]]

    (2) Dairy cows--

----------------------------------------------------------------------------------------------------------------
       Amount in grams/pound               Indications for use                  Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 0.5 to 1.5 per 100 lb of body    Dairy cows: For increased milk   This drug is effective for          017762
 weight.                              production.                      limited periods of time, and
                                                                       the effectiveness is limited
                                                                       to the declining phase of
                                                                       lactation. Administration
                                                                       must be accompanied with
                                                                       increased feed intake.
                                                                       Administration may increase
                                                                       heat sensitivity of the
                                                                       animal.
(2) [Reserved]
----------------------------------------------------------------------------------------------------------------


0
20. Revise Sec.  558.340 to read as follows:


Sec.  558.340  Maduramicin.

    (a) Specifications. Type A medicated articles containing 4.54 grams 
maduramicin per pound.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Tolerances. See Sec.  556.375 of this chapter.
    (d) Conditions of use in chickens--

----------------------------------------------------------------------------------------------------------------
        Amount in grams/ton                Indications for use                  Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 4.54 to 5.45...................  Broiler chickens: For            Feed continuously as sole           054771
                                      prevention of coccidiosis        ration. For broiler chickens
                                      caused by Eimeria acervulina,    only. Do not feed to laying
                                      E. tenella, E. brunetti, E.      hens. Withdraw 5 days before
                                      maxima, E. necatrix, and E.      slaughter.
                                      mivati.
(2) [Reserved]
----------------------------------------------------------------------------------------------------------------


0
21. Revise Sec.  558.348 to read as follows:


Sec.  558.348  Mibolerone.

    (a) Specifications. Each 6.5 ounce can contains 30 or 60 micrograms 
([micro]g) of mibolerone.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 30 [micro]g for animals 
weighing up to 25 pounds; 60 [micro]g for animals weighing 26 to 50 
pounds; 120 [micro]g for animals weighing 51 to 100 pounds; 180 
[micro]g for animals weighing over 100 pounds, or German Shepherds or 
German Shepherd mix weighing 30 to 80 pounds. Administer daily at least 
30 days before expected initiation of heat and continue as long as 
desired, but for not more than 12 months.
    (2) Indications for use. For the prevention of estrus (heat) in 
adult female dogs not intended primarily for breeding purposes.
    (3) Limitations. Mibolerone should not be used in bitches before 
first estrous period or in purebred Bedlington terriers. It is not 
intended for animals being used primarily for breeding purposes. Use 
orally in adult female dogs only. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

0
22. Revise In Sec.  558.430, revise paragraph (d) to read as follows:


Sec.  558.430  Nystatin.

* * * * *
    (d) Conditions of use--

----------------------------------------------------------------------------------------------------------------
        Amount in grams/ton                Indications for use                  Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 50.............................  Growing and laying chickens and  ..............................      054771
                                      growing turkeys: As an aid in
                                      the control of crop mycosis
                                      and mycotic diarrhea (Candida
                                      albicans).
(2) 100............................  Growing and laying chickens and  To be fed for 7 to 10 days....      054771
                                      growing turkeys: For the
                                      treatment of crop mycosis and
                                      mycotic diarrhea (Candida
                                      albicans).
----------------------------------------------------------------------------------------------------------------


0
23. Revise Sec.  558.465 to read as follows:


Sec.  558.465  Poloxalene.

    (a) Specifications. Dry Type A medicated articles containing 53 
percent poloxalene or liquid Type A medicated articles containing 99.5 
percent poloxalene.
    (b) Sponsor. See No. 066104 in Sec.  510.600(c) of this chapter.
    (c) Tolerances. See Sec.  556.517 of this chapter.
    (d) Special considerations. Poloxalene dry Type A article and 
liquid Type A article must be thoroughly blended and evenly distributed 
in feed prior to use. This may be accomplished by adding the Type A 
article to a small quantity of feed, mixing thoroughly, then adding 
this mixture to the remaining feed and again mixing thoroughly.
    (e) Conditions of use in cattle--

[[Page 45311]]



----------------------------------------------------------------------------------------------------------------
      Poloxalene in grams/ton              Indications for use                  Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(1) To deliver 1 to 2 grams per 100  Cattle: For prevention of        Dosage is 1 gram of poloxalene      054771
 pounds of body weight.               legume (alfalfa, clover) and     per 100 pounds of body weight
                                      wheat pasture bloat in cattle.   daily and continued during
                                                                       exposure to bloat producing
                                                                       conditions. If bloating
                                                                       conditions are severe, the
                                                                       dose is doubled. Treatment
                                                                       should be started 2 to 3 days
                                                                       before exposure to bloat-
                                                                       producing conditions. Repeat
                                                                       dosage if animals are exposed
                                                                       to bloat-producing conditions
                                                                       more than 12 hours after the
                                                                       last treatment. Do not exceed
                                                                       the higher dosage levels in
                                                                       any 24-hour period.
(2) [Reserved]
----------------------------------------------------------------------------------------------------------------

Sec.  558. 500   [Amended]

0
24. In Sec.  558.500, remove reserved paragraphs (e)(1)(iii) and (iv).

    Dated: July 15, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-15760 Filed 7-27-20; 8:45 am]
BILLING CODE 4164-01-P


