New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications, 18125-18126 [2020-06689]

Download as PDF 18125 Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations Tylosin grams/ton Combination in grams/ton * (ix) 8 to 10 .. * Monensin, 10 to 40 plus melengestrol, 0.25 to 2.0. * Indications for use Limitations * * Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). * * Feed continuously as sole ration to heifers at a rate of 0.5 to 2 pounds per head per day to provide 0.25 to 0.5 mg/head/day melengestrol acetate and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/ head/day tylosin. The melengestrol acetate portion of this Type C medicated feed must be mixed into the complete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin at feeding into the amount of complete feed consumed by an animal per day. A withdrawal time has not been established for preruminating calves. Do not use in calves to be processed for veal. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; melengestrol provided by No. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d) and 558.355(d). * * § 558.635 66. In § 558.635, revise paragraph (e)(1)(iv) to read as follows: ■ * * * Virginiamycin. * * * Combination in grams/ton Indications for use Limitations * (iv) 20 ................. * Diclazuril, 0.91 ........... * * Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin; and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima late in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesions scores and improve performance and health of birds challenged with E. maxima. * * Feed continuously as the sole ration. Do not use in hens producing eggs for human food. Diclazuril as provided by No. 058198 in § 510.600(c) of this chapter. * * * * * * * Dated: March 25, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. * * DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR Parts 520, 522, and 526 BILLING CODE 4164–01–P [Docket No. FDA–2019–N–0002] New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications AGENCY: Food and Drug Administration, HHS. 16:27 Mar 31, 2020 Jkt 250001 016592 054771 058198 * Sponsor * ACTION: * 058198 * Notification of withdrawal. The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs) at the sponsor’s request because the products are no longer manufactured or marketed. SUMMARY: Food and Drug Administration [FR Doc. 2020–06688 Filed 3–30–20; 8:45 am] VerDate Sep<11>2014 * (e) * * * (1) * * * * Virginiamycin grams/ton * jbell on DSKJLSW7X2PROD with RULES * Sponsor PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 Withdrawal of approval is effective March 30, 2020 DATES: FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary Medicine (HFV–212), Food and Drug E:\FR\FM\01APR1.SGM 01APR1 18126 Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5761, sujaya.dessai@fda.hhs.gov. Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland, has requested that FDA withdraw approval SUPPLEMENTARY INFORMATION: File No. 055–036 055–050 055–056 055–061 055–068 065–013 065–493 065–500 .......................... .......................... .......................... .......................... .......................... .......................... .......................... .......................... PRINCILLIN (ampicillin trihydrate) Capsules ......................................................................................... PRINCILLIN (ampicillin trihydrate) Soluble Powder ............................................................................... PRINCILLIN (ampicillin trihydrate) Bolus ............................................................................................... PRINCILLIN ‘‘125’’ For Oral Suspension ............................................................................................... BOVICLOX (cloxacillin benzathine) ....................................................................................................... Dihydrostreptomycin (dihydrostreptomycin sulfate) ............................................................................... JETPEN (penicillin G benzathine and penicillin G procaine) Aqueous Suspension ............................. TANDEM PEN (penicillin G procaine) ................................................................................................... Dated: March 25, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–06689 Filed 3–30–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF DEFENSE Department of the Navy 32 CFR Part 716 [Docket ID: USN–2019–HQ–0016] RIN 0703–AB23 Death Gratuity Department of the Navy (DON), DoD. ACTION: Final rule. This final rule removes the Department of the Navy (DON) regulation requiring the Secretary of the Navy to pay a death gratuity between $800 and $3,000 upon the death of a member of the naval service while on active duty, active duty for training, or inactive duty training. That benefit is enumerated in both U.S. Code and the Department of Defense (DoD) Financial Management Regulation. The DoD and DON have robust procedures for responding to the death of a service member. This part has been determined jbell on DSKJLSW7X2PROD with RULES SUMMARY: VerDate Sep<11>2014 21 CFR section Product name Therefore, under authority delegated to the Commissioner of Food and Drugs and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADAs 055–036, 055–050, 055–056, 055–061, 055–068, 065–013, 065–493, and 065–500, and all supplements and amendments thereto, is withdrawn, effective March 30, 2020. Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of these applications. AGENCY: of the NADAs listed in the following table because the products are no longer manufactured or marketed: 16:27 Mar 31, 2020 Jkt 250001 to be duplicative of statute and internal policy, thus it should be removed from the CFR. DATES: This rule is effective on April 1, 2020. 520.90c. 520.90e. 520.90f. 520.90d. 526.464b. 522.650. 522.1696a. 522.1696b. Dated: March 26, 2020. D.J. Antenucci, Commander, Judge Advocate General’s Corps, U.S. Navy, Federal Register Liaison Officer. [FR Doc. 2020–06694 Filed 3–31–20; 8:45 am] BILLING CODE 3810–FF–P FOR FURTHER INFORMATION CONTACT: CDR Dave Melson at 703–697–1311. 32 CFR part 716, ‘‘Death Gratuity,’’ last updated on May 2, 1979 (44 FR 25647), contains information regarding DON payments of death gratuity. The Department of Defense publishes the policies, process and requirements around death gratuity payments in Chapter 36 of Volume 7A of the Financial Management Regulation (DoD 7000.14–R was updated March 2018 and is available at https:// comptroller.defense.gov/Portals/45/ documents/fmr/Volume_07a.pdf). Additionally, 10 U.S. Code 1475–1480 captures all current guidance related to the death gratuity. It has been determined that publication of this CFR part removal for public comment is impracticable, unnecessary, and contrary to public interest since this subject matter is already addressed in statute and by internal DoD policies and procedures that are publicly available on the Department’s website. This rule is not significant under Executive Order (E.O.) 12866, ‘‘Regulatory Planning and Review.’’ Therefore, E.O. 13771, ‘‘Reducing Regulation and Controlling Regulatory Costs’’ does not apply. Removal of this part supports a recommendation of the DoD Regulatory Reform Task Force. SUPPLEMENTARY INFORMATION: List of Subjects in 32 CFR Part 716 Military personnel. PART 716—[REMOVED] Accordingly, by the authority of 5 U.S.C. 301, 32 CFR part 716 is removed. ■ PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R04–OAR–2019–0294; FRL–10007– 17–Region 4] Air Plan Approval; Tennessee: Chattanooga NSR Reform Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: The Environmental Protection Agency (EPA) is finalizing approval of revisions to the Tennessee State Implementation Plan (SIP) submitted through two letters dated June 25, 2008, and September 12, 2018. The SIP revisions were submitted by the Tennessee Department of Environment and Conservation (TDEC) on behalf of the Chattanooga/Hamilton County Air Pollution Control Bureau and modify the Prevention of Significant Deterioration (PSD) regulations in the Chattanooga portion of the Tennessee SIP to address changes to the federal new source review (NSR) regulations in recent years for the implementation of the national ambient air quality standards (NAAQS). Additionally, the SIP revisions include updates to Chattanooga’s regulations of nitrogen oxides (NOX) and other miscellaneous typographical and administrative updates. This action is being taken pursuant to the Clean Air Act (CAA or Act). DATES: This rule is effective May 1, 2020. SUMMARY: E:\FR\FM\01APR1.SGM 01APR1

Agencies

[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Rules and Regulations]
[Pages 18125-18126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06689]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, and 526

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of eight new animal drug applications (NADAs) at the sponsor's request 
because the products are no longer manufactured or marketed.

DATES: Withdrawal of approval is effective March 30, 2020

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug

[[Page 18126]]

Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, 
[email protected].

SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works, 
Newry BT35 6JP, Northern Ireland, has requested that FDA withdraw 
approval of the NADAs listed in the following table because the 
products are no longer manufactured or marketed:

------------------------------------------------------------------------
           File No.                 Product name        21 CFR  section
------------------------------------------------------------------------
055-036......................  PRINCILLIN             520.90c.
                                (ampicillin
                                trihydrate) Capsules.
055-050......................  PRINCILLIN             520.90e.
                                (ampicillin
                                trihydrate) Soluble
                                Powder.
055-056......................  PRINCILLIN             520.90f.
                                (ampicillin
                                trihydrate) Bolus.
055-061......................  PRINCILLIN ``125''     520.90d.
                                For Oral Suspension.
055-068......................  BOVICLOX (cloxacillin  526.464b.
                                benzathine).
065-013......................  Dihydrostreptomycin    522.650.
                                (dihydrostreptomycin
                                sulfate).
065-493......................  JETPEN (penicillin G   522.1696a.
                                benzathine and
                                penicillin G
                                procaine) Aqueous
                                Suspension.
065-500......................  TANDEM PEN             522.1696b.
                                (penicillin G
                                procaine).
------------------------------------------------------------------------

    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and in accordance with Sec.  514.116 Notice of withdrawal of 
approval of application (21 CFR 514.116), notice is given that approval 
of NADAs 055-036, 055-050, 055-056, 055-061, 055-068, 065-013, 065-493, 
and 065-500, and all supplements and amendments thereto, is withdrawn, 
effective March 30, 2020.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the voluntary withdrawal of 
approval of these applications.

    Dated: March 25, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06689 Filed 3-30-20; 8:45 am]
BILLING CODE 4164-01-P