New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application, 59135-59136 [2016-19915]

Download as PDF 59135 Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations Avilamycin in grams/ton Combination in grams/ton Indications for use Limitations (i) 13.6 to 40.9 .............. ........................ Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens. Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 10 days of age. Avilamycin in grams/ton Combinationin grams/ton Indications for use Limitations (i) 73 ............................. ........................ Weaned pigs less than 14 weeks of age: For the reduction in incidence and overall severity of diarrhea in the presence of pathogenic Escherichia coli in groups of weaned pigs. Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in pigs, do not administer to pigs 14 weeks of age or older. Sponsor 000986 (ii) [Reserved]. (2) Swine— Sponsor 000986 (ii) [Reserved]. § 558.274 [Amended] 24. Effective September 8, 2016, in § 558.625, revise paragraphs (b)(1), (f)(2)(i), (f)(2)(iii), and (f)(2)(vii) and remove paragraphs (f)(2)(viii) and (ix). The revisions read as follows: ■ 19. Effective September 8, 2016, in § 558.274, remove and reserve paragraphs (c)(1)(ii) and (c)(2)(ii). ■ 20. Effective September 8, 2016, in § 558.355, remove and reserve paragraph (f)(1)(xxviii) and revise paragraphs (f)(8)(i) and (ii). The revisions read as follows: ■ § 558.355 § 558.625 * * * * * (f) * * * (8) * * * (i) Decoquinate alone and in combination as in § 558.195. (ii) Melengestrol acetate alone and in combination as in § 558.342. * * * * * § 558.363 [Amended] 21. Effective September 8, 2016, in § 558.363, remove and reserve paragraph (d)(1)(vi). ■ § 558.550 [Amended] 22. Effective September 8, 2016, in § 558.550, remove and reserve paragraph (d)(1)(xxii). ■ § 558.618 jstallworth on DSK7TPTVN1PROD with RULES Tylosin and sulfamethazine. * [Amended] 23. In § 558.618, in paragraphs (e)(2)(ii) and (iii): ■ a. In the ‘‘Limitations’’ column, add ‘‘Tilmicosin as provided by Nos. 000986 or 016952; monensin as provided by No. 000986 in § 510.600(c) of this chapter.’’ to the end of the existing entries; and ■ b. In the ‘‘Sponsor’’ column, numerically add ‘‘016952’’. ■ * * * * (b) * * * (1) No. 000986: 40 and 100 grams per pound for use as in paragraph (f) of this section. * * * * * (f) * * * (2) * * * (i) Decoquinate alone and in combination as in § 558.195. * * * * * (iii) Melengestrol acetate alone and in combination as in § 558.342. * * * * * (vii) Zilpaterol alone and in combination as in § 558.665. ■ 25. Effective September 8, 2016, in § 558.630, revise paragraph (b)(1) to read as follows: § 558.630 Food and Drug Administration 21 CFR Part 558 Tylosin. * Monensin. DEPARTMENT OF HEALTH AND HUMAN SERVICES * * * * (b) * * * (1) No. 000986: 40 and 100 grams per pound for use as in paragraph (e) of this section. * * * * * Dated: August 8, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine. [FR Doc. 2016–19914 Filed 8–26–16; 8:45 am] BILLING CODE 4164–01–P [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. 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, sujaya.dessai@fda.hhs.gov. 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: SUMMARY: 21 CFR section File No. Product name 012–548 1 013–162 1 TYLOSIN (tylosin phosphate)/HYGROMIX (hygromycin B) ........................................................................................... TYLAN TM (tylosin phosphate) Type A medicated article .............................................................................................. 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 558.274 558.625 59136 Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations 21 CFR section File No. Product name 013–388 1 015–166 1 127–507 1 TYLAN (tylosin phosphate)/HYGROMIX (hygromycin B) Premix ................................................................................... TYLAN TM (tylosin phosphate) Type A medicated article .............................................................................................. TYLAN 5 SULFA-G (tylosin 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). TYLAN (tylosin phosphate)/COBAN (monensin) ............................................................................................................ TYLAN (tylosin phosphate)/MONTEBAN (narasin) ......................................................................................................... TYLAN TM (tylosin phosphate)/BIO-COX (salinomycin) ................................................................................................ 141–164 1 141–170 1 141–198 1 558.274 558.625 558.630 558.355 558.363 558.550 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 § 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 DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Parts 97 and 160 [Docket No. USCG–2000–7080] RIN 1625–AA25 [formerly RIN 2115–AF97] Cargo Securing Manuals Coast Guard, DHS. Correcting amendments. AGENCY: ACTION: The Coast Guard published an interim rule in the Federal Register on May 9, 2016, that prescribes when and how the loss or jettisoning of cargo at sea must be reported. That rule contained a typographical error that erroneously revised a force majeure regulation instead of a notice of hazardous conditions regulation. This document corrects that error. DATES: Effective August 29, 2016. FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call or jstallworth on DSK7TPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 14:52 Aug 26, 2016 Jkt 238001 email Mr. Ken Smith, Office of Operating and Environmental Standards (CG–OES–2), Coast Guard; telephone 202–372–1413, email Ken.A.Smith@ uscg.mil. SUPPLEMENTARY INFORMATION: Viewing Documents Associated With This Rule To view the interim rule published on May 9, 2016, or other documents in the docket for the Cargo Securing Manuals rulemaking, go to www.regulations.gov, type the docket number, USCG–2000– 7080, in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on ‘‘Open Docket Folder’’ in the first item listed. Use the following link to go directly to the docket: www.regulations.gov/ document?D=USCG-2000-7080-0040. Background In 2013 the Coast Guard proposed to revise 33 CFR 160.215, ‘‘Notice of hazardous conditions,’’ as part of its supplemental notice of proposed rulemaking regarding cargo securing manuals (78 FR 68784, November 15, 2013). In 2015, a different rulemaking, regarding notices of arrival, redesignated § 160.215 as § 160.216, and inserted a provision on force majeure in § 160.215 (80 FR 5281, January 30, 2015). In 2016, the Coast Guard published an interim rule on cargo securing manuals that implemented changes it had proposed in 2013, including the amendment of § 160.215 (81 FR 27992, May 9, 2016). Because the 2016 rule amended § 160.215 when it should have amended the redesignated section, § 160.216, the force majeure provision was unintentionally removed and part 160 contained two consecutive sections on notice of hazardous conditions. It was an error for the interim rule to revise § 160.215 and replace the force majeure provision. This rule corrects that error and a crossreference in 33 CFR 97.115 to § 160.215. Need for Correction As discussed above, the interim rule published May 9, 2016, incorrectly PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 replaced force majeure regulations in § 160.215, instead of amending notice of hazardous conditions regulations in § 160.216. List of Subjects 33 CFR Part 97 Cargo stowage and securing, Cargo vessels, Hazardous materials, Incorporation by reference, Reporting and recordkeeping requirements. 33 CFR Part 160 Administrative practice and procedure, Harbors, Hazardous materials transportation, Marine safety, Navigation (water), Personally identifiable information, Reporting and recordkeeping requirements, Seamen, Vessels, Waterways. For the reasons stated in the preamble, 33 CFR parts 97 and 160 are amended as follows: PART 97—RULES FOR THE SAFE OPERATION OF VESSELS, STOWAGE AND SECURING OF CARGOES 1. The authority citation for part 97 continues to read as follows: ■ Authority: 46 U.S.C. 2103, 3306; E.O. 12234; Department of Homeland Security Delegation No. 0170.1(92)(a) and (b). § 97.115 [Amended] 2. In § 97.115(a), remove ‘‘160.215’’, and add, in its place, ‘‘160.216’’. ■ PART 160—PORTS AND WATERWAYS SAFETY—GENERAL 3. The authority citation for part 160 continues to read as follows: ■ Authority: 33 U.S.C. 1223, 1231; 46 U.S.C. Chapter 701; Department of Homeland Security Delegation No. 0170.1. Subpart C is also issued under the authority of 33 U.S.C. 1225 and 46 U.S.C. 3715. § 160.216 ■ 4. Remove § 160.216. § 160.215 ■ [Removed] [Redesignated as § 160.216] 5. Redesignate § 160.215 as § 160.216. E:\FR\FM\29AUR1.SGM 29AUR1

Agencies

[Federal Register Volume 81, Number 167 (Monday, August 29, 2016)]
[Rules and Regulations]
[Pages 59135-59136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, sujaya.dessai@fda.hhs.gov.

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