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New Animal Drugs; Removal of Obsolete and Redundant Regulations

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Food and Drug Administration, HHS.


Final rule.


The Food and Drug Administration (FDA) is removing portions of a regulation that required sponsors to submit data regarding the subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugs administered in animal feed as these regulations have been determined to be obsolete or redundant. The portions of the regulation being removed are provisions listing certain feed use combinations for oxytetracycline and neomycin in the tables contained in that regulation. This rule does not finalize the provisions of the proposed rule regarding removing the remainder of the regulation.


This rule is effective April 30, 2010.

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William T. Flynn, Center for Veterinary Medicine (HFV-50), 7519 Standish Pl., Rockville, MD 20855, 240-276-9090, e-mail:

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I. Background

In the Federal Register of August 8, 2003 (68 FR 47272), FDA published a notice of proposed rulemaking to remove 21 CFR 558.15 Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals (§ 558.15 (21 CFR 558.15)) on the grounds that these regulations were obsolete or redundant. The proposed rule explained the nature and purpose of § 558.15, and noted that most of the products and use combinations subject to the listings in that section had approvals that were already codified in part 558, subpart B (21 CFR part 558, subpart B).

In the same issue of the Federal Register as the proposed rule, FDA's Center for Veterinary Medicine (CVM) published a Notice of Opportunity for Hearing (NOOH), which announced CVM's findings of effectiveness for nine products and use combinations that were listed in § 558.15, but which were subject to the Drug Efficacy Study Implementation (DESI) program (68 FR 47332). CVM proposed to withdraw the new animal drug applications (NADAs) for those nine products and use combinations lacking substantial evidence of effectiveness, following an opportunity to supplement the NADAs with labeling conforming to the relevant findings of effectiveness. For applications proposed to be withdrawn, the agency provided an opportunity for hearing.

FDA received hearing requests regarding two products owned by Pennfield Oil Co. (Pennfield). One is a bacitracin methylene disalicylate (BMD) Type A medicated article, NADA 141-137, that is listed in the table in § 558.15(g)(1). This listing is under Fermenta Animal Health Co., which is a predecessor in interest to Pennfield. The other is a two-way, fixed-combination Type A medicated article containing oxytetracycline and neomycin sulfate, NADA 138-939, that is listed in the table in § 558.15(g)(2).

The agency received only one set of comments on the 2003 proposed rule, from Pennfield. The comment objected to the removal of § 558.15 until the issues in the NOOH are addressed. It argued that the BMD listing in § 558.15 provides evidence of Pennfield's approval, and that removal of that section, without updating the BMD listing in part 558, subpart B, would result in a lack of recognition in the regulations of the approval that Pennfield currently has.

In 2006, FDA finalized portions of the 2003 proposed rule. In that final rule (71 FR 16219, March 31, 2006), FDA removed from the tables in § 558.15(g) products and use combinations that were not approved, and products and use combinations whose approval was reflected in part 558, subpart B. FDA retained only the listings for NADA 141-137 and NADA 138-939 in those tables. In addition, FDA retained § 558.15(a) through (f). FDA stated it intended to finalize the proposed rule to remove all of § 558.15 once, as part of the DESI program, either the approvals for NADA 141-137 and NADA 138-939 have been withdrawn or part 558, subpart B has been amended to reflect their approvals.

Subsequently, Pennfield filed a supplement to NADA 138-939 for its fixed-combination oxytetracycline/neomycin Type A medicated articles. The supplemental NADA, which provided labeling conforming to the relevant findings of effectiveness announced in the NOOH, was approved on July 2, 2009, and the regulations were amended in § 558.455 of subpart B to reflect that approval (74 FR 40723, August 13, 2009).Start Printed Page 16002

This oxytetracycline/neomycin use combination is listed in the table in § 558.15(g)(2) and is the only use combination listed in this provision. Because this use combination's approval is now reflected in § 558.455, FDA is removing § 558.15(g)(2) as obsolete or redundant. As in the 2006 final rule, FDA is retaining the sole listing in the table in § 558.15(g)(1) for NADA 141-137 as well as § 558.15(a) through (f), and intends to continue to finalize the proposed rule to remove all of § 558.15.

II. Environmental Impact

The agency has determined under 21 CFR 25.30(h) 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.

III. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-602), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order.

FDA proposed the removal of § 558.15 on August 8, 2003, because it was obsolete or redundant. The original purpose of § 558.15, requiring the submission of the results of studies on the long-term administration of then-marketed antimicrobial drugs in animal feed on the occurrence of multiple drug-resistant bacteria associated with these animals, was obsolete as FDA had a new strategy and concept for assessing the safety of antimicrobial new animal drugs, including subtherapeutic use of antimicrobials in animal feed, with regard to their microbiological effects on bacteria of human health concern. This final rule would delete the only animal drug use combination listed in § 558.15(g)(2) which is redundant because its approved conditions of use are now listed in § 558.455.

A. Benefits

Only one set of comments on the proposal was received by FDA. Because these comments did not question the benefits as described in the proposed rule, we retain the benefits for the final rule. This final rule is expected to provide greater clarity in the regulations for new animal drugs for use in animal feeds by deleting obsolete provisions in § 558.15. We do not expect this final rule to result in any direct human or animal health benefit. Rather, this final rule would remove regulations that are no longer necessary.

B. Compliance Costs

We do not expect the final rule that revokes § 558.15(g)(2) to have a substantive effect on any approved new animal drugs, or to cause any approved new animal drug to lose its marketing ability or experience a loss of sales.

C. Regulatory Flexibility Analysis

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. FDA has determined that this final rule does not impose compliance costs on the sponsors of any products that are currently marketed. Further, it does not cause any drugs that are currently marketed to lose their marketing ability. We therefore certify that this final rule would not have a significant economic effect on a substantial number of small entities.

D. Unfunded Mandates Reform Act

Section 202(a) of the Unfunded Mandates Reform Act requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $133 million, using the most current (2008) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

IV. Paperwork Reduction Act of 1995

FDA concludes that this rule does not have information collection requirements.

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List of Subjects in 21 CFR Part 558

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs,

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1. The authority citation for

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Authority: 21 U.S.C. 360b, 371.

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2. In § 558.15, remove and reserve paragraph (g)(2).

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Dated: March 18, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2010-7108 Filed 3-30-10; 8:45 am]