83_FR_13699 83 FR 13637 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

83 FR 13637 - 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 62 (March 30, 2018)

Page Range13637-13638
FR Document2018-06357

The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.

Federal Register, Volume 83 Issue 62 (Friday, March 30, 2018) 
[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Rules and Regulations]
[Pages 13637-13638]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06357]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2017-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 three new animal drug applications (NADAs). This action is being 
taken at the sponsors' request because these products are no longer 
manufactured or marketed.

DATES: Withdrawal of approval is effective April 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, sujaya.dessai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: During July and August 2017, the following 
sponsors requested that FDA withdraw approval of the NADAs listed in 
the following table because the products are no longer manufactured or 
marketed:

----------------------------------------------------------------------------------------------------------------
              File No.                           Sponsor                    Product name          21 CFR section
----------------------------------------------------------------------------------------------------------------
047-055.............................  Watson Laboratories, Inc.,    Chorionic Gonadotropin              522.1081
                                       311 Bonnie Circle, Corona,    Powder for Injection.
                                       CA 92880.

[[Page 13638]]

 
104-606.............................  Watson Laboratories, Inc.,    Dexamethasone Sodium                 522.540
                                       311 Bonnie Circle, Corona,    Phosphate Injection.
                                       CA 92880.
139-633.............................  Wildlife Laboratories, Inc.,  WILDNIL (carfentanil                 522.300
                                       1230 W. Ash St., suite D,     citrate) Injection.
                                       Windsor, CO 80550.
----------------------------------------------------------------------------------------------------------------

    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 047-055, 104-606, and 139-633, and all supplements and 
amendments thereto, is hereby withdrawn, effective April 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: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06357 Filed 3-29-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Rules and Regulations 13637 Chlortetracycline Combination in Indications for use Limitations Sponsor amount grams/ton * * * * * * * (ix) 500 to 4,000 to Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder Feed continuously on a hand-fed basis 054771 provide 10 mg/lb of cattle, dairy and beef replacement for not more than 5 days to provide body weight daily. heifers): For treatment of bacterial en- 10 mg chlortetracycline per lb. body teritis caused by E. coli and bacterial weight per day and not less than 60 pneumonia caused by P. multocida mg or more than 300 mg lasalocid per organisms susceptible to chlortetra- head per day in at least 1 pound of cycline; and for increased rate of feed. Daily lasalocid intakes in excess weight gain. of 200 mg/head/day in pasture cattle have not been shown to be more ef- fective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is re- quired. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. * * * * * * * (xxvi) 500 to 4,000 to Lasalocid, 30 to Cattle weighing up to 800 pounds: For Hand feed continuously for not more 054771 provide 10 mg/ 181.8. the treatment of bacterial enteritis than 5 days at a rate of 10 mg chlor- head/day. caused by E. coli and bacterial pneu- tetracycline and 1 mg lasalocid per monia caused by P. multocida sus- 2.2 lb. body weight daily to cattle with ceptible to chlortetracycline; and for a maximum of 360 mg of lasalocid per the control of coccidiosis caused by head per day. Do not allow horses or Eimeria bovis and E. zuernii. other equines access to feeds con- taining lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. * * * * * Dated: March 21, 2018. SUMMARY: The Food and Drug Leslie Kux, Administration (FDA) is withdrawing ■ 23. In § 558.325, revise paragraph Associate Commissioner for Policy. approval of three new animal drug (d)(2) to read as follows: applications (NADAs). This action is [FR Doc. 2018–06358 Filed 3–29–18; 8:45 am] § 558.325 Lincomycin. BILLING CODE 4164–01–P being taken at the sponsors’ request because these products are no longer * * * * * manufactured or marketed. (d) * * * DEPARTMENT OF HEALTH AND DATES: Withdrawal of approval is (2) The expiration date of VFDs for HUMAN SERVICES effective April 9, 2018. lincomycin medicated feeds must not Food and Drug Administration FOR FURTHER INFORMATION CONTACT: exceed 6 months from the date of Sujaya Dessai, Center for Veterinary issuance. VFDs for lincomycin shall not 21 CFR Part 522 Medicine (HFV–212), Food and Drug be refilled. Administration, 7519 Standish Pl., * * * * * [Docket No. FDA–2017–N–0002] Rockville, MD 20855, 240–402–5761, New Animal Drugs; Withdrawal of sujaya.dessai@fda.hhs.gov. § 558.575 [Amended] Approval of New Animal Drug SUPPLEMENTARY INFORMATION: During ■ 24. In § 558.575, in paragraph (e)(2)(ii) Applications July and August 2017, the following remove ‘‘and bacterial infections due to sponsors requested that FDA withdraw AGENCY: Food and Drug Administration, H. galmaxima,’’. HHS. approval of the NADAs listed in the following table because the products are ACTION: Notification of withdrawal. no longer manufactured or marketed: amozie on DSK30RV082PROD with RULES 21 CFR File No. Sponsor Product name section 047–055 ......................... Watson Laboratories, Inc., 311 Bonnie Circle, Chorionic Gonadotropin Powder for Injection ...... 522.1081 Corona, CA 92880. VerDate Sep<11>2014 18:02 Mar 29, 2018 Jkt 244001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\30MRR1.SGM 30MRR1

13638 Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Rules and Regulations 21 CFR File No. Sponsor Product name section 104–606 ......................... Watson Laboratories, Inc., 311 Bonnie Circle, Dexamethasone Sodium Phosphate Injection ..... 522.540 Corona, CA 92880. 139–633 ......................... Wildlife Laboratories, Inc., 1230 W. Ash St., suite WILDNIL (carfentanil citrate) Injection ................. 522.300 D, Windsor, CO 80550. Therefore, under authority delegated rule, call or email Tracy Girard, safety and property. Therefore, the to the Commissioner of Food and Drugs, Prevention Department, Sector Detroit, COTP is establishing a Special Local and in accordance with § 514.116 Notice Coast Guard; telephone 313–568–9564, Regulation around the event location to of withdrawal of approval of application or email Tracy.M.Girard@uscg.mil. help minimize risks to safety of life and (21 CFR 514.116), notice is given that SUPPLEMENTARY INFORMATION: property during this event. approval of NADAs 047–055, 104–606, and 139–633, and all supplements and I. Table of Abbreviations IV. Discussion of the Rule amendments thereto, is hereby CFR Code of Federal Regulations This rule establishes a temporary withdrawn, effective April 9, 2018. DHS Department of Homeland Security special local regulation from 8 a.m. until Elsewhere in this issue of the Federal FR Federal Register 11 a.m. on April 21, 2018. In light of the Register, FDA is amending the animal NPRM Notice of Proposed Rulemaking aforementioned hazards, the COTP has drug regulations to reflect the voluntary § Section determined that a special local COTP Captain of the Port withdrawal of approval of these U.S.C. United States Code regulation is necessary to protect applications. spectators, vessels, and participants. Dated: March 21, 2018. II. Background Information and The special local regulation will Regulatory History encompass the following waterway: All Leslie Kux, Associate Commissioner for Policy. The Coast Guard is issuing this waters of the Detroit River, Trenton temporary rule without prior notice and Channel between the following two [FR Doc. 2018–06357 Filed 3–29–18; 8:45 am] opportunity to comment pursuant to lines going from bank-to-bank: The first BILLING CODE 4164–01–P authority under section 4(a) of the line is drawn directly across the channel Administrative Procedure Act (APA) (5 from position 42°11.0′ N, 083°09.4′ W U.S.C. 553(b)). This provision (NAD 83); the second line, to the north, DEPARTMENT OF HOMELAND is drawn directly across the channel authorizes an agency to issue a rule SECURITY from position 42°11.7′ N, 083°08.9′ W without prior notice and opportunity to Coast Guard comment when the agency for good (NAD 83). cause finds that those procedures are An on-scene representative of the 33 CFR Part 100 ‘‘impracticable, unnecessary, or contrary COTP may permit vessels to transit the to the public interest.’’ Under 5 U.S.C. area when no race activity is occurring. [Docket No. USCG–2018–0235] 553(b)(B), the Coast Guard finds that The on-scene representative may be RIN 1625–AA08 good cause exists for not publishing a present on any Coast Guard, state, or notice of proposed rulemaking (NPRM) local law enforcement vessel assigned to Special Local Regulation; Wyandotte with respect to this rule because doing patrol the event. Vessel operators Rowing Regatta; Detroit River, Trenton so would be impracticable. The Coast desiring to transit through the regulated Channel; Wyandotte, MI Guard did not receive the final details area must contact the Coast Guard Patrol of this rowing event until there was Commander to obtain permission to do AGENCY: Coast Guard, DHS. insufficient time remaining before the so. The COTP or his designated on- ACTION: Temporary final rule. event to publish an NPRM. Thus, scene representative may be contacted SUMMARY: The Coast Guard is delaying the effective date of this rule to via VHF Channel 16 or at 313–568– establishing a special local regulation wait for a comment period to run would 9560. for certain waters of the Detroit River, be impracticable because it would The COTP or his designated on-scene Trenton Channel, Wyandotte, MI. This inhibit the Coast Guard’s ability to representative will notify the public of action is necessary and is intended to protect participants, mariners and the enforcement of this rule by all ensure safety of life on navigable waters vessels from the hazards associated with appropriate means, including a to be used for a rowing event this event. We are issuing this rule Broadcast Notice to Mariners and Local immediately prior to, during, and under 5 U.S.C. 553(d)(3), as the Coast Notice to Mariners. immediately after this event. Guard finds that good cause exists for V. Regulatory Analyses making it effective less than 30 days DATES: This temporary final rule is after publication in the Federal Register We developed this rule after effective from 8 a.m. until 11 a.m. on considering numerous statutes and for the same reason noted above. April 21, 2018. Executive orders related to rulemaking. ADDRESSES: To view documents III. Legal Authority and Need for Rule Below we summarize our analyses mentioned in this preamble as being The Coast Guard is issuing this rule based on a number of these statutes and available in the docket, go to http:// under authority in 33 U.S.C. 1233. The Executive orders, and we discuss First www.regulations.gov, type USCG–2018– Captain of the Port Detroit (COTP) has Amendment rights of protestors. amozie on DSK30RV082PROD with RULES 0235 in the ‘‘SEARCH’’ box and click determined that the likely combination ‘‘SEARCH.’’ Click on Open Docket of recreation vessels, commercial A. Regulatory Planning and Review Folder on the line associated with this vessels, and an unknown number of Executive Orders 12866 and 13563 rule. spectators in close proximity to a youth direct agencies to assess the costs and FOR FURTHER INFORMATION CONTACT: If rowing regatta along the water pose benefits of available regulatory you have questions on this temporary extra and unusual hazards to public alternatives and, if regulation is VerDate Sep<11>2014 18:02 Mar 29, 2018 Jkt 244001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\FR\FM\30MRR1.SGM 30MRR1


Document Created: 2018-11-01 08:58:17
Document Modified: 2018-11-01 08:58:17
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 April 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 13637 
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR