83_FR_49139 83 FR 48950 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

83 FR 48950 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 189 (September 28, 2018)

Page Range48950-48950
FR Document2018-21147

The Food and Drug Administration (FDA) is withdrawing approval of 12 new animal drug applications (NADAs) at the sponsor's request because these products are no longer manufactured or marketed.

Federal Register, Volume 83 Issue 189 (Friday, September 28, 2018) 
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Rules and Regulations]
[Page 48950]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-21147]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, 524, and 558

[Docket No. FDA-2018-N-0002]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 12 new animal drug applications (NADAs) at the sponsor's request 
because these products are no longer manufactured or marketed.

DATES: Withdrawal of approval is effective October 9, 2018.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5761, [email protected].

SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft. 
Worth, TX 76137, 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
------------------------------------------------------------------------
011-779...............  PURINA PIGEMIA 100         522.1182
                         (colloidal ferric oxide).
040-205...............  PURINA Horse Wormer        520.2380a
                         Medicated
                         (thiabendazole).
042-116...............  PURINA 6 DAY WORM-KILL     558.185
                         Feed Premix (coumaphos).
043-215...............  PURINA GRUB-KILL Pour-on   524.900
                         Cattle Insecticide
                         (famphur).
046-700...............  STATYL Medicated Premix    558.365
                         (nequinate).
091-260...............  PULVEX WORM CAPS           520.1804
                         (piperazine phosphate
                         monohydrate).
097-258...............  PURINA BAN-WORM for Pigs   558.485
                         (pyrantel tartrate).
102-942...............  PULVEX Multipurpose Worm   520.580
                         Caps (dichlorophene,
                         toluene).
113-748...............  PURINA PIGEMIA Oral (iron  520.1182
                         dextran complex).
135-941...............  CHECK-R-TON BM (pyrantel   558.485
                         tartrate).
136-116...............  PURINA WORM-A-RESTTM       520.905d
                         Litter Pack Premix
                         (fenbendazole).
140-869...............  PURINA SAF-T-BLOC BG       520.1840
                         Medicated Feed Block
                         (poloxalene, 6.6%).
------------------------------------------------------------------------

    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 011-779, 040-205, 042-116, 043-215, 046-700, 091-260, 097-258, 
102-942, 113-748, 135-941, 136-116, and 140-869, and all supplements 
and amendments thereto, is hereby withdrawn, effective October 9, 2018.
    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: September 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21147 Filed 9-27-18; 8:45 am]
 BILLING CODE 4164-01-P

48950 Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations Dated: September 24, 2018. 21 CFR on Narcotic Drugs, 1961. Also consistent File No. Product name Leslie Kux, section therewith, DEA is adding such drugs to Associate Commissioner for Policy. 136–116 ... PURINA WORM-A- 520.905d the list of substances that may only be [FR Doc. 2018–21146 Filed 9–27–18; 8:45 am] RESTTM Litter Pack imported or exported pursuant to a BILLING CODE 4164–01–P Premix (fenbendazole). permit. 140–869 ... PURINA SAF-T-BLOC 520.1840 BG Medicated Feed DATES: Effective September 28, 2018. Block (poloxalene, FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND 6.6%). Kathy L. Federico, Regulatory Drafting HUMAN SERVICES and Policy Support Section (DPW), Therefore, under authority delegated Diversion Control Division, Drug Food and Drug Administration to the Commissioner of Food and Drugs, Enforcement Administration; Mailing and in accordance with § 514.116 Notice Address: 8701 Morrissette Drive, 21 CFR Parts 520, 522, 524, and 558 of withdrawal of approval of application Springfield, Virginia 22152; Telephone: [Docket No. FDA–2018–N–0002] (21 CFR 514.116), notice is given that (202) 598–6812. approval of NADAs 011–779, 040–205, SUPPLEMENTARY INFORMATION: New Animal Drugs; Withdrawal of 042–116, 043–215, 046–700, 091–260, Approval of New Animal Drug 097–258, 102–942, 113–748, 135–941, Background and Legal Authority Applications 136–116, and 140–869, and all The United States is a party to the supplements and amendments thereto, Single Convention on Narcotic Drugs, AGENCY: Food and Drug Administration, is hereby withdrawn, effective October 1961 (Single Convention), and other HHS. 9, 2018. international conventions designed to ACTION: Notification of withdrawal. Elsewhere in this issue of the Federal establish effective control over Register, FDA is amending the animal international and domestic traffic in SUMMARY: The Food and Drug drug regulations to reflect the voluntary controlled substances. 21 U.S.C. 801(7). Administration (FDA) is withdrawing withdrawal of approval of these The Single Convention entered into approval of 12 new animal drug applications. force for the United States on June 24, applications (NADAs) at the sponsor’s Dated: September 24, 2018. 1967, after the Senate gave its advice request because these products are no Leslie Kux, and consent to the United States’ longer manufactured or marketed. Associate Commissioner for Policy. accession. See Single Convention, 18 DATES: Withdrawal of approval is U.S.T. 1407. The enactment and effective October 9, 2018. [FR Doc. 2018–21147 Filed 9–27–18; 8:45 am] enforcement of the Controlled BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: Substances Act (CSA) are the primary Sujaya Dessai, Center for Veterinary means by which the United States Medicine (HFV–212), Food and Drug carries out its obligations under the DEPARTMENT OF JUSTICE Administration, 7519 Standish Pl., Single Convention.1 Various provisions Rockville, MD 20855, 240–402–5761, Drug Enforcement Administration of the CSA directly reference the Single sujaya.dessai@fda.hhs.gov. Convention. One such provision is 21 SUPPLEMENTARY INFORMATION: Virbac 21 CFR Parts 1308, 1312 U.S.C. 811(d)(1), which relates to AH, Inc., 3200 Meacham Blvd., Ft. scheduling of controlled substances. [Docket No. DEA–486] As stated in subsection 811(d)(1), if Worth, TX 76137, has requested that FDA withdraw approval of the NADAs control of a substance is required ‘‘by Schedules of Controlled Substances: United States obligations under listed in the following table because the Placement in Schedule V of Certain products are no longer manufactured or international treaties, conventions, or FDA-Approved Drugs Containing protocols in effect on October 27, 1970, marketed: Cannabidiol; Corresponding Change to the Attorney General shall issue an 21 CFR Permit Requirements order controlling such drug under the File No. Product name section AGENCY: Drug Enforcement schedule he deems most appropriate to 011–779 ... PURINA PIGEMIA 100 522.1182 Administration, Department of Justice. carry out such obligations, without (colloidal ferric oxide). ACTION: Final order. regard to the findings required by 040–205 ... PURINA Horse Wormer 520.2380a [subsections 811(a) or 812(b)] and Medicated (thiabendazole). SUMMARY: With the issuance of this final without regard to the procedures 042–116 ... PURINA 6 DAY WORM- 558.185 order, the Acting Administrator of the prescribed by [subsections 811(a) and KILL Feed Premix Drug Enforcement Administration (b)].’’ This provision is consistent with (coumaphos). the Supremacy Clause of the U.S. 043–215 ... PURINA GRUB-KILL 524.900 places certain drug products that have Pour-on Cattle Insecti- been approved by the Food and Drug Constitution (art. VI, sec. 2), which cide (famphur). Administration (FDA) and which provides that all treaties made under the 046–700 ... STATYL Medicated Pre- 558.365 contain cannabidiol (CBD) in schedule authority of the United States ‘‘shall be mix (nequinate). the supreme Law of the Land.’’ In 091–260 ... PULVEX WORM CAPS 520.1804 V of the Controlled Substances Act (piperazine phosphate (CSA). Specifically, this order places accordance with this constitutional monohydrate). FDA-approved drugs that contain CBD 097–258 ... PURINA BAN-WORM for 558.485 derived from cannabis and no more than 1 See S. Rep. No. 91–613, at 4 (1969) (‘‘The United Pigs (pyrantel tartrate). States has international commitments to help 0.1 percent tetrahydrocannabinols in daltland on DSKBBV9HB2PROD with RULES 102–942 ... PULVEX Multipurpose 520.580 control the worldwide drug traffic. To honor those Worm Caps schedule V. This action is required to commitments, principally those established by the (dichlorophene, tol- satisfy the responsibility of the Acting Single Convention on Narcotic Drugs of 1961, is uene). Administrator under the CSA to place a clearly a Federal responsibility.’’); Control of 113–748 ... PURINA PIGEMIA Oral 520.1182 Papaver Bracteatum, 1 Op. O.L.C. 93, 95 (1977) (iron dextran complex). drug in the schedule he deems most (‘‘[A] number of the provisions of [the CSA] reflect 135–941 ... CHECK-R-TON BM 558.485 appropriate to carry out United States Congress’ intent to comply with the obligations (pyrantel tartrate). obligations under the Single Convention imposed by the Single Convention.’’). VerDate Sep<11>2014 17:35 Sep 27, 2018 Jkt 244001 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 E:\FR\FM\28SER1.SGM 28SER1


Document Created: 2018-09-28 01:23:02
Document Modified: 2018-09-28 01:23:02
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionNotification of withdrawal.
DatesWithdrawal of approval is effective October 9, 2018.
ContactSujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, [email protected]
FR Citation83 FR 48950 
CFR Citation21 CFR 520
21 CFR 522
21 CFR 524
21 CFR 558
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