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 Department of Health and Human Services Food and Drug Administration 21 CFR Parts 510, 520, and 522
[Docket No. FDA-2019-N-5405]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notification of withdrawal.
 SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of seven new animal drug applications (NADAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of these applications have repeatedly failed to file required annual reports for the applications.
 DATES: Withdrawal of approval is effective February 23, 2021.
 FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5720, 
                        *david.alterman@fda.hhs.gov.*


SUPPLEMENTARY INFORMATION: The holders of approved applications to market new animal drugs are required to submit annual reports to FDA concerning each of their approved applications in accordance with § 514.80 (21 CFR 514.80). In the 
                    **Federal Register**
                     of January 8, 2020 (85 FR 919), FDA published a notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw approval of seven NADAs because the sponsors had failed to submit the required annual reports for these applications. The holders of these applications did not respond to the NOOH. Failure to file a written notice of participation and request for a hearing as required by § 514.200(b) (21 CFR 514.200(b)) constitutes an election by the applicant not to make use of the opportunity for a hearing concerning the proposal to withdraw approval of the applications and a waiver of any contentions concerning the legal status of the drug products. Therefore, approval of the seven applications listed in table 1 is being withdrawn. Table 1—NADAs for Which Approval Is Withdrawn
Application No.
Trade name 
                             (drug)
Sponsor031-971
CUPRATE (cupric glycinate)
Walco International, Inc., 15 West Putnam, Porterville, CA 93257.( print page 10820)045-863
PALOSEIN (orgotein)
OXIS International, Inc., 6040 N. Cutter Circle, suite 317, Portland, OR 97217-3935.046-922
SERGEANTS SURE SHOT (
                            *n-*
                            butyl chloride) Capsules
ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 68105.046-923
SERGEANTS (
                            *n*
                            -butyl chloride) Puppy Worm Capsules
ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 68105.065-067
Tetracycline Hydrochloride Tablets
Premo Pharmaceutical Laboratories, Inc., 111 Leuning St., South Hackensack, NJ 07606.140-850
ELITE (dichlorophene and toluene) Dog and Cat Wormer
RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620.141-107
BAPTEN for Injection (ß-aminopropionitrile fumarate)
Alaco, Inc., 1500 North Wilmot Rd., suite 290-C, Tucson, AZ 85712.
 The Commissioner of Food and Drugs (the Commissioner), under section 512(e)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(e)(2)(A)), finds that the holders of the applications listed in this document have repeatedly failed to submit reports required by § 514.80. In addition, under § 514.200(b), the Commissioner finds that the holders of the applications have waived any contentions concerning the legal status of the drug products. Therefore, under these findings, approval of the applications listed in this document, and all amendments and supplements thereto, is hereby withdrawn, effective February 23, 2021. Elsewhere in this issue of the 
                    **Federal Register**
                    *,*
                     FDA is amending the animal drug regulations to reflect the withdrawal of approval of these applications. Dated: February 11, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy.


[FR Doc. 2021-03250 Filed 2-22-21; 8:45 am] BILLING CODE 4164-01-P