[Federal Register Volume 79, Number 147 (Thursday, July 31, 2014)] [Rules and Regulations] [Pages 44277-44278] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2014-17912] [[Page 44277]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 522, 529, and 558 [Docket No. FDA-2014-N-0002] New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to remove a cross-reference to a combination drug medicated feed that is no longer codified. DATES: This rule is effective July 31, 2014. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, [email protected]. SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during June 2014 as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain these documents at the Center for Veterinary Medicine (CVM) FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm. Also, the regulations are being amended in 21 CFR 558.76 to remove a cross-reference to a combination drug medicated feed which was removed in earlier corrections to part 558 (79 FR 10976, February 27, 2014). This amendment is being made to improve the accuracy of the regulations. This rule does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because it is a rule of ``particular applicability.'' Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. Table 1--Original and Supplemental NADAs and ANADAs Approved During June 2014 ---------------------------------------------------------------------------------------------------------------- New animal drug 21 CFR FOIA NEPA NADA/ ANADA Sponsor product name Action Sections Summary Review ---------------------------------------------------------------------------------------------------------------- 108-901........ Zoetis Inc., 333 LUTALYSE Supplemental 522.690, yes......... CE\1\ \2\ Portage St., (dinoprost approval of 522.1077, Kalamazoo, MI injection) label references 529.1940 49007. Injection. to approved uses with gonadorelin hydrochloride injection and progesterone intravaginal inserts. 128-686........ Zoetis Inc., 333 BIO-COX 60 Supplemental 558.4 no.......... CE\1\ \2\ Portage St., (salinomycin approval of Kalamazoo, MI sodium) Type A revised assay 49007. medicated limits for Type article. A medicated articles. 200-473 \3\.... Huvepharma AD, TYLOVET (tylosin Supplemental 520.2640 no.......... CE\1\ \2\ 5th Floor, 3A, tartrate) approval of a Nikolay Haytov Soluble. change in Str., 1113 marketing status Sophia, Bulgaria. from over-the- counter (OTC) to by veterinary prescription (Rx). 200-560........ Zoetis Inc., 333 ACTOGAIN Original approval 558.500 yes......... CE\1\ \2\ Portage St., (ractopamine as a generic Kalamazoo, MI HCl), RUMENSIN copy of NADA 141- 49007. (monensin), MGA 234. (melengestrol acetate), and Type B and C medicated feeds. 200-562........ Zoetis Inc., 333 ACTOGAIN Original approval 558.500 yes......... CE\1\ \2\ Portage St., (ractopamine as a generic Kalamazoo, MI HCl), RUMENSIN copy of NADA 141- 49007. (monensin), 233. TYLAN (tylosin phosphate), and MGA (melengestrol acetate) Type B and C medicated feeds. ---------------------------------------------------------------------------------------------------------------- \1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the human environment. \2\ CE granted under 21 CFR 25.33(a)(1). \3\ The application listed was identified as being affected by guidance for industry (GFI)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. [[Page 44278]] List of Subjects 21 CFR Parts 520, 522, and 529 Animal drugs. 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 520, 522, 529, and 558 are amended as follows: PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 1. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 520.2640 [Amended] 0 2. In Sec. 520.2640, in paragraphs (b)(1) and (d) remove ``No. 000986'' and in its place add ``Nos. 000986 and 016592''; and in paragraph (b)(2) remove ``Nos. 016592 and 061623'' and in its place add ``No. 061623''. PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 3. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 0 4. In Sec. 522.690, revise the section heading and paragraph (d)(2)(v) to read as follows: Sec. 522.690 Dinoprost. * * * * * (d) * * * (2) * * * (v) Dinoprost injection as provided by No. 054771 in Sec. 510.600(c) of this chapter may also be used concurrently with gonadorelin hydrochloride injection as in Sec. 522.1077 and with progesterone intravaginal inserts as in Sec. 529.1940 of this chapter. * * * * * 0 5. In Sec. 522.1077, revise paragraph (c)(1)(ii) to read as follows: Sec. 522.1077 Gonadorelin hydrochloride. * * * * * (c) * * * (1) * * * (ii) For use with dinoprost injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows, administer to each cow 100 to 200 mcg gonadorelin by intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost by intramuscular injection, followed 30 to 72 hours later by 100 to 200 mcg gonadorelin by intramuscular injection. Dinoprost injection as in Sec. 522.690, provided by No. 054771 in Sec. 510.600(c) of this chapter. * * * * * PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 0 6. The authority citation for 21 CFR part 529 continues to read as follows: Authority: 21 U.S.C. 360b. 0 7. In Sec. 529.1940, revise paragraph (d), the second sentence in paragraph (e)(1)(i) and the last sentence in paragraph (e)(1)(iii) to read as follows: Sec. 529.1940 Progesterone intravaginal inserts. * * * * * (d) Special considerations. Product labeling shall bear the following warning: ``Avoid contact with skin by wearing protective gloves when handling inserts. Store removed inserts in a sealable container until they can be disposed of in accordance with applicable local, state, and Federal regulations.'' (e) * * * (1) * * * (i) * * * When used for indications listed in paragraph (e)(1)(ii)(A) of this section, administer 25 mg dinoprost as a single intramuscular injection 1 day prior to insert removal (Day 6). * * * * * * * * (iii) * * * Dinoprost injection for use in paragraphs (e)(1)(ii)(A) and (e)(1)(ii)(B) of this section as in Sec. 522.690 of this chapter, provided by No. 054771 in Sec. 510.600(c) of this chapter. * * * * * PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 8. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. Sec. 558.4 [Amended] 0 9. In paragraph (d) of Sec. 558.4, in the ``Category I'' table, in the ``Assay limits percent type A'' column, in the entry for ``Salinomycin'', remove ``95-115'' and in its place add ``90-110''. Sec. 558.76 [Amended] 0 10. In Sec. 558.76, remove and reserve paragraph (d)(3)(vii). Sec. 558.500 [Amended] 0 11. In Sec. 558.500, in the table in paragraphs (e)(2)(viii) and (e)(2)(x), in the ``Sponsor'' column, remove ``000986'' and in its place add ``000986, 054771''. Dated: July 24, 2014. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2014-17912 Filed 7-30-14; 8:45 am] BILLING CODE 4164-01-P