80 FR 245 pgs. 79474-79476 - New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate
Type: RULEVolume: 80Number: 245Pages: 79474 - 79476
Pages: 79474, 79475, 79476Docket number: [Docket No. FDA-2015-N-0002]
FR document: [FR Doc. 2015-32000 Filed 12-21-15; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2015-N-0002]
New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmgate LLC for the use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for chickens, turkeys, pheasants, quail, and feedlot cattle. This supplemental approval reflects FDA's effectiveness conclusions that relied on the National Academy of Sciences/National Research Council Drug Efficacy Study Group's evaluation of the effectiveness of this drug as well indications for use not subject to this review.
DATES:
This rule is effective December 22, 2015.
FOR FURTHER INFORMATION CONTACT:
Matthew Lucia, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0589, email: matthew.lucia@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In the Federal Register of August 8, 2003 (68 FR 47332), as corrected October 7, 2003 (68 FR 57911), as part of the Drug Efficacy Study Implementation (DESI) program, the Center for Veterinary Medicine (CVM) announced the effective conditions of use for several drug products and use combinations that were listed in 21 CFR 558.15. CVM proposed to withdraw the NADAs for those products or use combinations lacking substantial evidence of effectiveness following a 90-day opportunity to supplement the NADAs with labeling conforming to the relevant findings of effectiveness.
In response to that notice of opportunity for a hearing (NOOH), Pennfield Oil Co. (Pennfield), 14040 Industrial Rd., Omaha, NE 68144, filed a hearing request for its approved, non-DESI finalized NADA 141-137 for a bacitracin methylenedisalicylate Type A medicated article.
In March 2015, Pennfield transferred sponsorship of NADA 141-137 to Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC 28405 (Pharmgate) (80 FR 13226, March 13, 2015). Subsequently, Pharmgate filed a supplement to NADA 141-137 for PENNITRACIN MD 50G (bacitracin Type A medicated article) with labeling conforming to the findings of effectiveness in the 2003 NOOH. In addition, the submitted labeling included indications for use approved by FDA that were not subject to DESI findings of effectiveness (34 FR 7906, May 20, 1969).
The supplemental NADA provides for use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for several production and therapeutic indications in broiler and replacement chickens, growing turkeys, growing pheasants, growing quail, and beef steers and heifers fed in confinement for slaughter. The supplemental NADA is approved as of October 6, 2015, and the regulations are amended in 21 CFR 558.76 to reflect the approval. Pharmgate, as successor to Pennfield, has since withdrawn the hearing request for NADA 141-137.
Approval of this supplemental NADA did not require review of any new safety or effectiveness data. Therefore, a freedom of information summary was not prepared.
The DESI evaluation was concerned only with the effectiveness of the drug products and use combinations. Nothing in this document constitutes a bar to further proceedings with respect to questions of safety of the subject drugs in treated animals or of the drugs or their metabolites in food products derived from treated animals.
Products that comply with FDA's findings of effectiveness are eligible for copying, as described in the "Generic Animal Drug and Patent Term Restoration Act; Eighth Policy Letter," August 21, 1991 (56 FR 41561). Accordingly, sponsors may now obtain approval of abbreviated NADAs for this Type A medicated article.
The Agency has determined under 21 CFR 25.33(a)(1) 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.
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
1. The authority citation for 21 CFR part 558 continues to read as follows:
Authority:
21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
2. Amend §?558.76 as follows:
a. Revise the section heading and paragraph (a);
b. Redesignate paragraphs (b), (c), and (d) as paragraphs (c), (d), and (e);
c. Add new paragraph (b); and
d. Revise newly redesignated paragraph (e)(1).
The revisions and addition read as follows:
§?558.76 Bacitracin methylenedisalicylate.
(a) Specifications. (1) Type A medicated articles containing 10, 25, 30, 40, 50, 60, or 75 grams bacitracin methylenedisalicylate per pound.
(2) Type A medicated article containing 50 grams bacitracin methylenedisalicylate per pound.
(b) Sponsors. See sponsors in §?510.600(c) of this chapter:
(1) No. 054771 for use of products in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(iii), (e)(1)(v) through (xiii), and (e)(1)(xv) of this section.
(2) No. 069254 for use of products in paragraph (a)(2) of this section as in paragraphs (e)(1)(ii), (e)(1)(iv), (e)(1)(xiv), and (e)(1)(xvi) of this section.
(e) * * *
[top] (1) It is used as follows:
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| Bacitracin methylenedisalicylate amount | Combination in grams per ton (g/ton) | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| (i) 4 to 50 g/ton | Chickens, turkeys, and pheasants: For increased rate of weight gain and improved feed efficiency | 054771 | ||
| (ii) 4 to 50 g/ton | Broiler and replacement chickens, growing turkeys, and growing pheasants: For increased rate of weight gain and improved feed efficiency | 069254 | ||
| (iii) 5 to 20 g/ton | Quail not over 5 weeks of age: For increased rate of weight gain and improved feed efficiency | 054771 | ||
| (iv) 5 to 20 g/ton | Growing quail: For increased rate of weight gain and improved feed efficiency | For use in quail not over 5 weeks of age | 069254 | |
| (v) 10 to 25 g/ton | Chickens: For increased egg production and improved feed efficiency for egg production | For first 7 months of production | 054771 | |
| (vi) 10 to 30 g/ton | Swine: For increased rate of weight gain and improved feed efficiency | For growing and finishing swine | 054771 | |
| (vii) 10 to 30 g/ton | Chlortetracycline approximately 400, varying with body weight and food consumption to provide 10 milligrams (mg) per pound of body weight per day | Swine: For increased rate of weight gain and improved feed efficiency; for treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline | Feed for not more than 14 days; bacitracin methylenedisalicylate provided by No. 054771; chlortetracycline provided by Nos. 054771 and 069254 in §?510.600(c) of this chapter | 054771 069254 |
| (viii) 10 to 30 g/ton | Swine: For control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline | Feed for not more than 14 days; chlortetracycline and bacitracin methylenedisalicylate as provided by No. 054771 in §?510.600(c) of this chapter | 054771 | |
| (ix) 50 g/ton | Broiler chickens: As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Replacement chickens: As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin | Feed continuously as sole ration | 054771 | |
| (x) 100 to 200 g/ton | Broiler chickens: As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Replacement chickens: As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin | Feed continuously as sole ration. Start at first clinical signs of disease, vary dosage based on severity of infection, administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce medication to prevention level (50 g/ton) | 054771 | |
| (xi) 200 g/ton | Turkeys: As an aid in the control of transmissible enteritis in growing turkeys complicated by organisms susceptible to bacitracin methylenedisalicylate. Quail: For the prevention of ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylenedisalicylate | Feed continuously as the sole ration | 054771 | |
| (xii) 250 g/ton | 1. Growing/finishing swine: For control of swine dysentery Treponema hyodysenteriae on premises with history of swine dysentery but where signs of the disease have not yet occurred; or following an approved treatment of the disease condition | As the sole ration. Not for use in swine weighing more than 250 pounds. Diagnosis should be confirmed by a veterinarian a when results are not satisfactory | 054771 | |
| 2. Pregnant sows: For control of clostridial enteritis caused by C. perfringens in suckling piglets | As the sole ration. Feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. Diagnosis should be confirmed by veterinarian when results are not satisfactory | |||
| (xiii) To provide 70 mg per head per day | Feedlot beef cattle: For reduction in the number of liver condemnations due to abscesses | Administer continuously throughout the feeding period | 054771 | |
| (xiv) To provide 70 mg per head per day | Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses | Administer continuously throughout the feeding period | 069254 | |
| (xv) To provide 250 mg per head per day | Feedlot beef cattle: For reduction in the number of liver condemnations due to abscesses | Administer continuously for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period | 054771 | |
| (xvi) To provide 250 mg per head per day | Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses | Administer continuously for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period | 069254 |
Dated: December 16, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-32000 Filed 12-21-15; 8:45 am]
BILLING CODE 4164-01-P