New Animal Drugs; Ceftiofur Sodium; Lincomycin Powder; Naracin; Tylosin
Federal Register, Volume 77 Issue 96 (Thursday, May 17, 2012)
Federal Register Volume 77, Number 96 (Thursday, May 17, 2012)
Rules and Regulations
Pages 29216-29218
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2012-11937
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, and 558
Docket No. FDA-2012-N-0002
New Animal Drugs; Ceftiofur Sodium; Lincomycin Powder; Naracin; Tylosin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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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 March 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
DATES: This rule is effective May 17, 2012.
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:george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA's Center for Veterinary Medicine (CVM) is adopting use of a monthly Federal Register document to codify approval actions for NADAs and abbreviated ANADAs. CVM will no longer publish a separate rule for each action. This approach will allow a more efficient use of available resources.
In this document, FDA is amending the animal drug regulations to reflect the original and supplemental approval actions during March 2012, as listed in table 1 of this document. FDA is also informing the public of the availability of environmental review documents required under the National Environmental Policy Act (NEPA), where applicable. For actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA) 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.
Page 29217
Table 1--Original and Supplemental NADAs and ANADAs Approved During March 2012
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New animal drug 21 CFR FOIA
NADA/ANADA Sponsor product name Action Section summary NEPA review
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118-980....... Elanco Animal MONTEBAN Supplement 558.363 Yes........ Environmental
Health, A (narasin) Type increasing the assessment (EA)/
Division of Eli A medicated upper dose Finding of no
Lilly & Co., article. limit for significant
Lilly Corporate narasin in impact (FONSI).
Center, broiler feed.
Indianapolis,
IN 46285.
111-636....... Pharmacia & LINCOMIX Supplement 520.1263c Yes........ Categorically
Upjohn Co., a (lincomycin adding an excluded
Division of hydrochloride) indication for (CE).\1\
Pfizer, Inc., Soluble Powder. control of
235 East 42d American
St., New York, foulbrood in
NY 10017. honey bees.
200-421....... Hospira, Inc., Ceftiofur for Original 522.313c Yes........ CE.
275 N. Field Injection approval of
Dr., Lake (ceftiofur generic copy of
Forest, IL sodium) Sterile NADA 140-338.
60045. Powder.
200-455....... Cross Vetpharm TYLOMED-WS Supplement 520.2640 Yes........ CE.\1\
Group, Ltd., (tylosin adding an
Broomhill Rd., tartrate) indication for
Tallaght, Soluble Powder. control of
Dublin 24, porcine
Ireland. proliferative
enteropathies.
200-473....... Huvepharma AD, TYLOVET Soluble Supplement 520.2640 Yes........ CE.\1\
33 James (tylosin adding an
Boucher Blvd., tartrate). indication for
Sophia 1407, control of
Bulgaria. porcine
proliferative
enteropathies.
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\1\ The Agency has determined under 21 CFR 25.33 that this action is CE from the requirement to submit an EA or
an environmental impact statement (EIS) because it is of a type that does not individually or cumulatively
have a significant effect on the human environment.
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.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Parts 520 and 522
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 510, 520, 522, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), alphabetically add an entry for ``Hospira, Inc.''; and in the table in paragraph (c)(2), numerically add an entry for ``000409'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *
(c) * * *
(1) * * *
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Drug labeler
Firm name and address code
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* * * * *
Hospira, Inc., 275 North Field Dr., Lake Forest, IL 000409
60045.................................................
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
000409.............................. Hospira Inc., 275 North Field Dr.,
Lake Forest, IL 60045.
* * * * *
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.1263c, revise paragraph (b) and add paragraph (d)(3) to read as follows:
Sec. 520.1263c Lincomycin powder.
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 000009 for use as in paragraph (d) of this section.
(2) Nos. 046573, 054925, 061623, and 076475 for use as in paragraphs (d)(1) and (d)(2) of this section.
* * * * *
(d) * * *
(3) Honey bees--(i) Amount. Mix 100 milligrams lincomycin with 20 grams confectioners'/powdered sugar and dust over the top bars of the brood chamber once weekly for 3 weeks.
(ii) Indications for use. For the control of American foulbrood (Paenibacillus larvae).
(iii) Limitations. The drug should be fed early in the spring or late in the fall and consumed by the bees before the main honey flow begins to avoid contamination of production honey. Complete treatments at least 4 weeks before main honey flow.
0
5. In Sec. 520.2640, revise paragraph (b) introductory text to read as follows:
Sec. 520.2640 Tylosin.
* * * * *
(b) Sponsors. See Nos. 000986, 016592, and 061623 in Sec. 510.600(c) of this chapter.
* * * * *
Page 29218
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for 21 CFR part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
7. In Sec. 522.313c, revise paragraphs (b), (e)(2)(ii), (e)(3)(ii), (e)(4)(ii), and (e)(8)(i) to read as follows:
Sec. 522.313c Ceftiofur sodium.
* * * * *
(b) Sponsors. See Nos. 000009, 000409, and 068330 in Sec. 510.600(c) of this chapter.
* * * * *
(e) * * *
(2) * * *
(ii) Indications for use. For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. Also, for the treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
* * * * *
(3) * * *
(ii) Indications for use. For treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
* * * * *
(4) * * *
(ii) Indications for use. For treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
* * * * *
(8) * * *
(i) Amount. 1.0 mg/lb (2.2 mg/kg) body weight by subcutaneous injection. Treatment should be repeated at 24-hour intervals for 5 to 14 days.
* * * * *
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.
0
9. In Sec. 558.363, revise paragraph (d)(1)(i) introductory text to read as follows:
Sec. 558.363 Narasin.
* * * * *
(d) * * *
(1) * * *
(i) Amount per ton. Narasin, 54 to 90 grams.
* * * * *
Dated: May 7, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
FR Doc. 2012-11937 Filed 5-16-12; 8:45 am
BILLING CODE 4160-01-P
