81_FR_59302 81 FR 59135 - New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application

81 FR 59135 - New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 167 (August 29, 2016)

Page Range59135-59136
FR Document2016-19915

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

Federal Register, Volume 81 Issue 167 (Monday, August 29, 2016) 
[Federal Register Volume 81, Number 167 (Monday, August 29, 2016)]
[Rules and Regulations]
[Pages 59135-59136]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-19915]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2016-N-0002]


New Animal Drugs for Use in Animal Feed; Withdrawal of Approval 
of a New Animal Drug Application

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 these products are no longer manufactured or marketed.

DATES: Withdrawal of approval is effective September 8, 2016.

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: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 has 
requested that FDA withdraw approval of the NADAs listed in the 
following table because the products are no longer manufactured or 
marketed:

------------------------------------------------------------------------
                                                              21 CFR
        File No.                   Product name               section
------------------------------------------------------------------------
012-548 \1\............  TYLOSIN (tylosin phosphate)/            558.274
                          HYGROMIX (hygromycin B).
013-162 \1\............  TYLAN TM (tylosin phosphate)            558.625
                          Type A medicated article.

[[Page 59136]]

 
013-388 \1\............  TYLAN (tylosin phosphate)/              558.274
                          HYGROMIX (hygromycin B) Premix.
015-166 \1\............  TYLAN TM (tylosin phosphate)            558.625
                          Type A medicated article.
127-507 \1\............  TYLAN 5 SULFA-G (tylosin                558.630
                          phosphate and sulfamethazine),
                          TYLAN 10 SULFA-G (tylosin
                          phosphate and sulfamethazine),
                          TYLAN 20 SULFA-G (tylosin
                          phosphate and sulfamethazine),
                          TYLAN 40 SULFA-G (tylosin
                          phosphate and sulfamethazine).
141-164 \1\............  TYLAN (tylosin phosphate)/COBAN         558.355
                          (monensin).
141-170 \1\............  TYLAN (tylosin phosphate)/              558.363
                          MONTEBAN (narasin).
141-198 \1\............  TYLAN TM (tylosin phosphate)/           558.550
                          BIO-COX (salinomycin).
------------------------------------------------------------------------
\1\ These NADAs were identified as being affected by guidance for
  industry #213, ``New Animal Drugs and New Animal Drug Combination
  Products Administered in or on Medicated Feed or Drinking Water of
  Food-Producing Animals: Recommendations for Drug Sponsors for
  Voluntarily Aligning Product Use Conditions with GFI #209,'' December
  2013.

    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, 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 
012-548, 013-162, 013-388, 015-166, 127-507, 141-164, 141-170, and 141-
198, and all supplements and amendments thereto, is hereby withdrawn, 
effective September 8, 2016.
    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: August 8, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-19915 Filed 8-26-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations 59135 Avilamycin in Combination in Indications for use Limitations Sponsor grams/ton grams/ton (i) 13.6 to 40.9 .............. ........................ Broiler chickens: For the prevention of Feed as the sole ration for 21 consecu- 000986 mortality caused by necrotic enteritis tive days. To assure responsible anti- associated with Clostridium microbial drug use in broiler chickens, perfringens in broiler chickens. treatment administration must begin on or before 10 days of age. (ii) [Reserved]. (2) Swine— Avilamycin in Combinationin Indications for use Limitations Sponsor grams/ton grams/ton (i) 73 ............................. ........................ Weaned pigs less than 14 weeks of Feed as the sole ration for 21 consecu- 000986 age: For the reduction in incidence tive days. To assure responsible anti- and overall severity of diarrhea in the microbial drug use in pigs, do not ad- presence of pathogenic Escherichia minister to pigs 14 weeks of age or coli in groups of weaned pigs. older. (ii) [Reserved]. § 558.274 [Amended] ■ 24. Effective September 8, 2016, in DEPARTMENT OF HEALTH AND ■ 19. Effective September 8, 2016, in § 558.625, revise paragraphs (b)(1), HUMAN SERVICES § 558.274, remove and reserve (f)(2)(i), (f)(2)(iii), and (f)(2)(vii) and paragraphs (c)(1)(ii) and (c)(2)(ii). remove paragraphs (f)(2)(viii) and (ix). Food and Drug Administration ■ 20. Effective September 8, 2016, in The revisions read as follows: § 558.355, remove and reserve 21 CFR Part 558 § 558.625 Tylosin. paragraph (f)(1)(xxviii) and revise * * * * * paragraphs (f)(8)(i) and (ii). (b) * * * [Docket No. FDA–2016–N–0002] The revisions read as follows: (1) No. 000986: 40 and 100 grams per New Animal Drugs for Use in Animal § 558.355 Monensin. pound for use as in paragraph (f) of this Feed; Withdrawal of Approval of a New section. * * * * * Animal Drug Application (f) * * * * * * * * (f) * * * AGENCY: Food and Drug Administration, (8) * * * (2) * * * (i) Decoquinate alone and in HHS. (i) Decoquinate alone and in combination as in § 558.195. combination as in § 558.195. ACTION: Notification of withdrawal. (ii) Melengestrol acetate alone and in * * * * * SUMMARY: The Food and Drug combination as in § 558.342. (iii) Melengestrol acetate alone and in Administration (FDA) is withdrawing * * * * * combination as in § 558.342. approval of eight new animal drug § 558.363 [Amended] * * * * * applications (NADAs) at the sponsor’s (vii) Zilpaterol alone and in request because these products are no ■ 21. Effective September 8, 2016, in combination as in § 558.665. longer manufactured or marketed. § 558.363, remove and reserve ■ 25. Effective September 8, 2016, in paragraph (d)(1)(vi). § 558.630, revise paragraph (b)(1) to read DATES: Withdrawal of approval is as follows: effective September 8, 2016. § 558.550 [Amended] FOR FURTHER INFORMATION CONTACT: ■ 22. Effective September 8, 2016, in § 558.630 Tylosin and sulfamethazine. Sujaya Dessai, Center for Veterinary § 558.550, remove and reserve * * * * * Medicine (HFV–212), Food and Drug paragraph (d)(1)(xxii). (b) * * * Administration, 7519 Standish Pl., § 558.618 [Amended] (1) No. 000986: 40 and 100 grams per Rockville, MD 20855, 240–402–5761, pound for use as in paragraph (e) of this sujaya.dessai@fda.hhs.gov. ■ 23. In § 558.618, in paragraphs section. (e)(2)(ii) and (iii): SUPPLEMENTARY INFORMATION: Elanco * * * * * ■ a. In the ‘‘Limitations’’ column, add Animal Health, A Division of Eli Lilly ‘‘Tilmicosin as provided by Nos. 000986 Dated: August 8, 2016. & Co., Lilly Corporate Center, or 016952; monensin as provided by No. Tracey H. Forfa, Indianapolis, IN 46285 has requested 000986 in § 510.600(c) of this chapter.’’ Deputy Director, Center for Veterinary that FDA withdraw approval of the to the end of the existing entries; and Medicine. NADAs listed in the following table ■ b. In the ‘‘Sponsor’’ column, [FR Doc. 2016–19914 Filed 8–26–16; 8:45 am] because the products are no longer jstallworth on DSK7TPTVN1PROD with RULES numerically add ‘‘016952’’. BILLING CODE 4164–01–P manufactured or marketed: 21 CFR File No. Product name section 012–548 1 TYLOSIN (tylosin phosphate)/HYGROMIX (hygromycin B) ........................................................................................... 558.274 013–162 1 TYLAN TM (tylosin phosphate) Type A medicated article .............................................................................................. 558.625 VerDate Sep<11>2014 14:52 Aug 26, 2016 Jkt 238001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\FR\FM\29AUR1.SGM 29AUR1

59136 Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations 21 CFR File No. Product name section 013–388 1 TYLAN (tylosin phosphate)/HYGROMIX (hygromycin B) Premix ................................................................................... 558.274 015–166 1 TYLAN TM (tylosin phosphate) Type A medicated article .............................................................................................. 558.625 127–507 1 TYLAN 5 SULFA-G (tylosin phosphate and sulfamethazine), TYLAN 10 SULFA-G (tylosin phosphate and 558.630 sulfamethazine), TYLAN 20 SULFA-G (tylosin phosphate and sulfamethazine), TYLAN 40 SULFA-G (tylosin phosphate and sulfamethazine). 141–164 1 TYLAN (tylosin phosphate)/COBAN (monensin) ............................................................................................................ 558.355 141–170 1 TYLAN (tylosin phosphate)/MONTEBAN (narasin) ......................................................................................................... 558.363 141–198 1 TYLAN TM (tylosin phosphate)/BIO-COX (salinomycin) ................................................................................................ 558.550 1 These NADAs were identified as being affected by guidance for industry #213, ‘‘New Animal Drugs and New Animal Drug Combination Prod- ucts Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,’’ December 2013. Therefore, under authority delegated email Mr. Ken Smith, Office of replaced force majeure regulations in to the Commissioner of Food and Drugs Operating and Environmental Standards § 160.215, instead of amending notice of and redelegated to the Center for (CG–OES–2), Coast Guard; telephone hazardous conditions regulations in Veterinary Medicine, and in accordance 202–372–1413, email Ken.A.Smith@ § 160.216. with § 514.116 Notice of withdrawal of uscg.mil. List of Subjects approval of application (21 CFR SUPPLEMENTARY INFORMATION: 514.116), notice is given that approval 33 CFR Part 97 of NADAs 012–548, 013–162, 013–388, Viewing Documents Associated With This Rule Cargo stowage and securing, Cargo 015–166, 127–507, 141–164, 141–170, vessels, Hazardous materials, and 141–198, and all supplements and To view the interim rule published on Incorporation by reference, Reporting amendments thereto, is hereby May 9, 2016, or other documents in the and recordkeeping requirements. withdrawn, effective September 8, 2016. docket for the Cargo Securing Manuals Elsewhere in this issue of the Federal rulemaking, go to www.regulations.gov, 33 CFR Part 160 Register, FDA is amending the animal type the docket number, USCG–2000– Administrative practice and drug regulations to reflect the voluntary 7080, in the ‘‘SEARCH’’ box and click procedure, Harbors, Hazardous withdrawal of approval of these ‘‘SEARCH.’’ Click on ‘‘Open Docket materials transportation, Marine safety, applications. Folder’’ in the first item listed. Use the Navigation (water), Personally Dated: August 8, 2016. following link to go directly to the identifiable information, Reporting and Tracey H. Forfa, docket: www.regulations.gov/ recordkeeping requirements, Seamen, document?D=USCG-2000-7080-0040. Vessels, Waterways. Deputy Director, Center for Veterinary Medicine. Background For the reasons stated in the [FR Doc. 2016–19915 Filed 8–26–16; 8:45 am] In 2013 the Coast Guard proposed to preamble, 33 CFR parts 97 and 160 are BILLING CODE 4164–01–P revise 33 CFR 160.215, ‘‘Notice of amended as follows: hazardous conditions,’’ as part of its PART 97—RULES FOR THE SAFE supplemental notice of proposed OPERATION OF VESSELS, STOWAGE DEPARTMENT OF HOMELAND rulemaking regarding cargo securing AND SECURING OF CARGOES SECURITY manuals (78 FR 68784, November 15, 2013). In 2015, a different rulemaking, ■ 1. The authority citation for part 97 Coast Guard regarding notices of arrival, continues to read as follows: redesignated § 160.215 as § 160.216, and 33 CFR Parts 97 and 160 Authority: 46 U.S.C. 2103, 3306; E.O. inserted a provision on force majeure in 12234; Department of Homeland Security [Docket No. USCG–2000–7080] § 160.215 (80 FR 5281, January 30, Delegation No. 0170.1(92)(a) and (b). 2015). In 2016, the Coast Guard RIN 1625–AA25 [formerly RIN 2115–AF97] published an interim rule on cargo § 97.115 [Amended] securing manuals that implemented ■ 2. In § 97.115(a), remove ‘‘160.215’’, Cargo Securing Manuals changes it had proposed in 2013, and add, in its place, ‘‘160.216’’. AGENCY: Coast Guard, DHS. including the amendment of § 160.215 (81 FR 27992, May 9, 2016). Because the PART 160—PORTS AND WATERWAYS ACTION: Correcting amendments. 2016 rule amended § 160.215 when it SAFETY—GENERAL SUMMARY: The Coast Guard published an should have amended the redesignated interim rule in the Federal Register on section, § 160.216, the force majeure ■ 3. The authority citation for part 160 May 9, 2016, that prescribes when and provision was unintentionally removed continues to read as follows: how the loss or jettisoning of cargo at and part 160 contained two consecutive Authority: 33 U.S.C. 1223, 1231; 46 U.S.C. sea must be reported. That rule sections on notice of hazardous Chapter 701; Department of Homeland contained a typographical error that conditions. It was an error for the Security Delegation No. 0170.1. Subpart C is erroneously revised a force majeure interim rule to revise § 160.215 and also issued under the authority of 33 U.S.C. jstallworth on DSK7TPTVN1PROD with RULES replace the force majeure provision. 1225 and 46 U.S.C. 3715. regulation instead of a notice of hazardous conditions regulation. This This rule corrects that error and a cross- § 160.216 [Removed] document corrects that error. reference in 33 CFR 97.115 to § 160.215. ■ 4. Remove § 160.216. DATES: Effective August 29, 2016. Need for Correction FOR FURTHER INFORMATION CONTACT: If As discussed above, the interim rule § 160.215 [Redesignated as § 160.216] you have questions on this rule, call or published May 9, 2016, incorrectly ■ 5. Redesignate § 160.215 as § 160.216. VerDate Sep<11>2014 14:52 Aug 26, 2016 Jkt 238001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\29AUR1.SGM 29AUR1


Document Created: 2016-08-26 23:49:33
Document Modified: 2016-08-26 23:49:33
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 September 8, 2016.
ContactSujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, [email protected]
FR Citation81 FR 59135 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR