Animal drugs, feeds, and related products: Lasalocid and chlortetracycline,
[Federal Register: April 27, 2006 (Volume 71, Number 81)]
[Rules and Regulations]
[Page 24814-24817]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ap06-7]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
New Animal Drugs for Use in Animal Feeds; Lasalocid and Chlortetracycline
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 of a new animal drug application (NADA) filed by Alpharma Inc. The NADA provides for use of approved single-ingredient Type A medicated articles containing lasalocid and chlortetracycline to formulate two-way, combination drug Type B and Type C medicated feeds for pasture cattle and cattle fed in confinement for slaughter.
DATES: This rule is effective April 27, 2006.
FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0232, e-mail: eric.dubbin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Drive, Fort Lee, NJ 07024, filed NADA 141-250 for use of BOVATEC (lasalocid sodium) and AUREOMYCIN (chlortetracycline) Type A medicated articles to formulate two-way, combination drug Type B and Type C medicated feeds for pasture cattle and cattle fed in confinement for slaughter. The NADA is approved as of March 31, 2006, and the regulations are amended in Sec. Sec. 558.128 and 558.311 (21 CFR 558.128 and 558.311) to reflect the approval. The basis of approval is discussed in the freedom of information summary.
In addition, Sec. 558.128 is amended to reflect an approved concentration for single-ingredient chlortetracycline Type C medicated cattle feed which, in error, was omitted from the final rule announcing its approval (67 FR 43248, June 27, 2002). Also, FDA has found that the April 1, 2005, edition of parts 500 to 599 of title 21 of the Code of Federal Regulations (CFR) does not accurately reflect several special considerations regarding use for lasalocid. These special considerations were inadvertently deleted as a publication error. At this time, the regulations are being amended in Sec. 558.311 to correct this error. Furthermore, Sec. 558.311 is amended to codify an approved label statement warning against the use of medicated feeds containing lasalocid in calves to be processed for veal. These actions are being taken to improve the accuracy of the regulations.
In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application 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.
The agency has determined under 21 CFR 25.33(a)(2) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
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 in 21 CFR Part 558
Animal drugs, Animal feeds.
0 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 part 558 is amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0 1. The authority citation for 21 CFR part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
0 2. Amend Sec. 558.128 as follows: 0 a. In the table in paragraph (e)(4), redesignate paragraphs (e)(4)(v) through (e)(4)(viii) as paragraphs (e)(4)(vi) through (e)(4)(ix); 0 b. In the table in paragraph (e)(4), add new paragraph (e)(4)(v) to read as follows; 0 c. Redesignate paragraphs (e)(6)(viii) through (e)(6)(xiii) as paragraphs (e)(6)(ix) through (e)(6)(xiv); and 0 d. Add new paragraph (e)(6)(viii).
The additions read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(4) * * *
[[Page 24815]]
Chlortetracycline amount
Indications for use
Limitations
Sponsor
* * * * * * *
(v) 500 to 4,000 g/ton
Calves, beef and nonlactating dairy Hand feed continuously for 046573. cattle; treatment of bacterial
not more than 5 days to enteritis caused by E. coli and
provide 10 mg/lb body bacterial pneumonia caused by P.
weight per day. multocida organisms susceptible to chlortetracycline.
* * * * * * *
* * * * *
(6) * * *
(viii) Lasalocid in accordance with Sec. 558.311. * * * * *
0 3. In Sec. 558.311, add paragraphs (d)(5), (d)(6), and (d)(7); and in the table in paragraph (e)(1) add paragraphs (xx) through (xxiii) to read as follows:
Sec. 558.311 Lasalocid.
* * * * *
(d) * * *
(5) Required label statements:
(i) For liquid Type B feed (cattle and sheep): Mix thoroughly with grain and/or roughage prior to feeding. Feeding undiluted, mixing errors, or inadequate mixing (recirculation or agitation) may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.
(ii) For Type A articles or Type B feeds (cattle and sheep): Feeding undiluted or mixing errors may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.
(iii) For Type A articles, Type B or Type C feeds (cattle): A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(6) Lasalocid Type A medicated articles containing lasalocid dried fermentation residue are for use in cattle and sheep feed only.
(7) Each use in a free-choice Type C cattle feed as in paragraphs (e)(1)(xii) and (e)(1)(xviii) of this section must be the subject of an approved NADA or supplemental NADA as provided in Sec. 510.455 of this chapter.
(e)(1) * * *
Lasalocid sodium activity in Combination in
Indications for use
Limitations
Sponsor grams per ton grams per ton
* * * * * * *
(xx) 10 to 30. Chlortetracycline 1. Cattle fed in confinement for Feed continuously in complete 046573 25 to 100.
slaughter: For improved feed feed at a rate of 350 mg efficiency; and for control of chlortetracycline and not less bacterial pneumonia associated than 100 mg nor more than 360 with shipping fever complex mg of lasalocid sodium caused by Pasteurella spp.
activity per head per day. susceptible to chlortetracycline. ................. 2. Cattle under 700 pounds fed Feed continuously in complete 046573 in confinement for slaughter: feed at a rate of 350 mg For improved feed efficiency; chlortetracycline and not less and for control of active
than 100 mg nor more than 360 infection of anaplasmosis
mg of lasalocid sodium caused by Anaplasma marginale activity per head per day. susceptible to chlortetracycline.
(xxi) 10 to 30. Chlortetracycline Cattle fed in confinement for Feed continuously in complete 046573 500 to 2000. slaughter: For improved feed feed for not more than 5 days efficiency; and for treatment to provide 10 mg of bacterial enteritis caused chlortetracycline per lb body by E. coli and bacterial
weight per day and not less pneumonia caused by P.
than 100 mg nor more than 360 multocida organisms susceptible mg of lasalocid sodium to chlortetracycline.
activity per head per day.
(xxii) 25 to 30. Chlortetracycline 1. Cattle fed in confinement for Feed continuously in complete 046573 25 to 42.2.
slaughter: For increased rate feed at a rate of 350 mg of weight gain and improved chlortetracycline and not less feed efficiency; and for
than 250 mg nor more than 360 control of bacterial pneumonia mg of lasalocid sodium associated with shipping fever activity per head per day. complex caused by Pasteurella spp. susceptible to chlortetracycline. ................. 2. Cattle under 700 pounds fed Feed continuously in complete 046573 in confinement for slaughter: feed at a rate of 350 mg For increased rate of weight chlortetracycline and not less gain and improved feed
than 250 mg nor more than 360 efficiency; and for control of mg of lasalocid sodium active infection of
activity per head per day. anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.
[[Page 24816]]
(xxiii) 25 to Chlortetracycline Cattle fed in confinement for Feed continuously in complete 046573 30.
500 to 1200. slaughter: For increased rate feed for not more than 5 days of weight gain and improved to provide 10 mg feed efficiency; and for
chlortetracycline per lb body treatment of bacterial
weight per day and not less enteritis caused by E. coli and than 250 mg nor more than 360 bacterial pneumonia caused by mg of lasalocid sodium P. multocida organisms
activity per head per day. susceptible to chlortetracycline.
(xxiv) 30 to Chlortetracycline 1. Beef cattle under 700 pounds: Hand feed continuously at a
046573 181.8.
25 to 2800.
For control of coccidiosis
rate of 350 mg caused by Eimeria bovis and E. chlortetracycline per head per zuernii; and for control of day and 1 mg lasalocid per 2.2 active infection of
lb body weight per day with a anaplasmosis caused by
maximum of 360 mg lasalocid Anaplasma marginale susceptible per head per day. to chlortetracycline. ................. 2. Beef cattle up to 800 pounds: Hand feed continuously at a
046573 For control of coccidiosis
rate of 350 mg caused by Eimeria bovis and E. chlortetracycline per head per zuernii; and for control of day and 1 mg lasalocid per 2.2 bacterial pneumonia associated lb body weight per day with a with shipping fever complex maximum of 360 mg lasalocid caused by Pasteurella spp.
per head per day. susceptible to chlortetracycline.
(xxv) 30 to Chlortetracycline Cattle up to 800 pounds: For Hand feed continuously for not 046573 181.8.
500 to 4000. control of coccidiosis caused more than 5 days to provide 10 by Eimeria bovis and E.
mg chlortetracycline per lb zuernii; and for treatment of body weight per day and 1 mg bacterial enteritis caused by lasalocid per 2.2 lb body E. coli and bacterial pneumonia weight per day with a maximum caused by P. multocida
of 360 mg lasalocid per head organisms susceptible to
per day. chlortetracycline.
(xxvi) 30 to Chlortetracycline 1. Pasture cattle (slaughter, Hand feed continuously at a
046573 600.
25 to 700.
stocker, feeder cattle, and rate of 350 mg beef replacement heifers): for chlortetracycline and not less increased rate of weight gain; than 60 mg or more than 300 mg and for control of bacterial lasalocid per head daily in at pneumonia associated with
least 1 lb of feed. Intakes of shipping fever complex caused lasalocid in excess of 200 mg/ by Pasteurella spp. susceptible head/day have not been shown to chlortetracycline.
to be more effective than 200 mg/head/day. ................. 2. Pasture cattle under 700 Hand feed continuously at a
046573 pounds (slaughter, stocker, rate of 350 mg feeder cattle, and beef
chlortetracycline and not less replacement heifers): for
than 60 mg or more than 300 mg increased rate of weight gain; lasalocid per head daily in at and for control of active
least 1 lb of feed. Intakes of infection of anaplasmosis
lasalocid in excess of 200 mg/ caused by Anaplasma marginale head/day have not been shown susceptible to
to be more effective than 200 chlortetracycline.
mg/head/day.
(xxvii) 30 to Chlortetracycline Pasture cattle over 700 pounds Hand feed continuously at a
046573 600.
25 to 1100.
(slaughter, stocker, feeder rate of 0.5 mg cattle, and beef replacement chlortetracycline per lb body heifers): For increased rate of weight per day and not less weight gain; and for control of than 60 mg or more than 300 mg control of active infection of lasalocid per head daily in at anaplasmosis caused by
least 1 lb of feed. Intakes of Anaplasma marginale susceptible lasalocid in excess of 200 mg/ to chlortetracycline.
head/day have not been shown to be more effective than 200 mg/head/day.
(xxiii) 30 to Chlortetracycline Pasture cattle (slaughter,
Hand feed continuously for not 046573 600.
500 to 4000. stocker, feeder cattle, and more than 5 days to provide 10 dairy and beef replacement
mg chlortetracycline per lb heifers): For increased rate of body weight per day and not weight gain; and for treatment less than 60 mg or more than of bacterial enteritis caused 300 mg lasalocid per head by E. coli and bacterial
daily in at least 1 lb of pneumonia caused by P.
feed. Intakes of lasalocid in multocida organisms susceptible excess of 200 mg/head/day have to chlortetracycline.
not been shown to be more effective than 200 mg/head/ day.
* * * * * * *
[[Page 24817]]
* * * * *
Dated: April 17, 2006. Stephen F. Sundlof, Director, Center for Veterinary Medicine.
[FR Doc. 06-3953 Filed 4-26-06; 8:45 am]
BILLING CODE 4160-01-S
