Source: https://www.federalregister.gov/documents/2016/08/24/2016-20148/new-animal-drugs-for-use-in-animal-feed-category-definitions
Timestamp: 2019-05-26 07:24:04
Document Index: 143809423

Matched Legal Cases: ['§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', '§\u2009558', 'art 558', '§\u2009558']

This rule is effective December 1, 2016. Submit either electronic or written comments by November 7, 2016. See Section IV for further discussion of the effective date.
57796-57800 (5 pages)
https://www.federalregister.gov/d/2016-20148 https://www.federalregister.gov/d/2016-20148
The Food and Drug Administration (FDA, the Agency, we) is amending the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.
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David Edwards, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6205, david.edwards@fda.hhs.gov.
FDA is issuing this direct final rule to revise the definitions of the two categories of new animal drugs used in Start Printed Page 57797medicated feeds to base category assignment only on approved uses in major animal species. This action is being taken to address a potential consequence of animal drug sponsor cooperation in implementing a strategy initiated by the FDA Center for Veterinary Medicine (CVM) to address antimicrobial resistance by taking measures to ensure the judicious use of antimicrobial drugs in animal agriculture. Under this program, sponsors of antimicrobial new animal drugs that also have importance in human medicine were requested to voluntarily withdraw approval of production (e.g., growth production, feed efficiency) indications for their drug products that are intended for use in the feed or water of food-producing animals. Based on the existing drug category definitions, the voluntary withdrawal of production indications by these drug sponsors would, in some cases, result in a change to a medicated feed drug's category, potentially leading to additional consequences not foreseen at the time the program was initiated.
This direct final rule revises the category definitions such that they will be based only on whether a withdrawal period is required for a major species.[1] Under this new definition, a Category I Type A medicated article will not be recategorized to Category II based on the existence of a withdrawal period for an approved indication in a minor species, even if that minor species indication is the next lowest approved use level that remains after the production indication has been withdrawn. However, if the next lowest use level (apart from the minor species indication) is an indication approved for use in a major species that has a withdrawal period, under the new definition the drug will move to Category II.
The purpose of this revision is to preserve the present availability of medicated feeds intended for therapeutic uses in minor species and to prevent a significant disincentive for future development of additional therapies for minor species. We believe this revision will not compromise public health due to the comparatively lower exposure by humans to potential drug residues in edible tissues of food-producing minor species inherent in their less frequent consumption.
FDA is amending 21 CFR 558.3 Definitions and general considerations applicable to this part (§ 558.3) to base the definition for each of the two categories (Category I and Category II) of new animal drugs used in medicated feeds only on approved uses in major species. Definitions for “major species” and “minor species” are also being added to this section.
FDA is issuing these regulations based on its authority under the new animal drug provisions in sections 512 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b) and under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), which gives the Agency general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.
The revisions made by this direct final rule are intended to preserve the availability of medicated feeds intended for therapeutic use in minor animal species. In addition, these revisions will prevent a significant disincentive for future development of additional therapies for minor species. No additional costs or benefits will accrue from this rulemaking.
FDA is issuing this direct final rule to revise the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. To strengthen the Agency's medicated feed program, FDA issued a final rule in the Federal Register of March 3, 1986 (51 FR 7382), which, among other things, established two categories of new animal drugs used in medicated feeds. As discussed in the final rule, the Agency placed these drugs into categories based on their likelihood of producing unsafe residues in the edible products of treated animals (51 FR 7382). Category I consists of those drugs that require no withdrawal period at the lowest use level in each species for which they are approved. Category II consists of those drugs that require a withdrawal period at the lowest use level for at least one species for which they are approved, or that are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern, regardless of whether a withdrawal period is required.
This action is being taken to address a potential consequence of animal drug Start Printed Page 57798sponsor cooperation in implementing a strategy initiated by CVM to address antimicrobial resistance by taking measures to ensure the judicious use of antimicrobials of importance to human medicine (i.e., medically important antimicrobials) in animal agriculture. Specifically, CVM's initiative to ensure the judicious use of medically important antimicrobial drugs in animal agriculture advocates two specific changes to the approved conditions of use of medically important antimicrobials that are administered through the medicated feed or water of food-producing animals.
Given the potential for implementation of GFI #213 to result in the foreseeable consequence of the withdrawal of approval of needed therapeutic indications for minor species, the definitions of the two categories of new animal drugs used in medicated feeds in § 558.3 are being revised to base category assignment only on uses in major species. This revision is expected to preserve the availability of drugs intended for therapeutic use in minor species and also prevent a significant disincentive for future development of additional therapies for minor species without compromising public health.
We are amending paragraphs (b)(1)(i) and (ii) of this Agency's regulations at § 558.3 (Definitions and general considerations applicable to this part.) to base the definition for each of the two categories of new animal drugs (Category I and Category II) used in medicated feeds only on approved uses in major species. Section 558.3(b) is further amended to add definitions for “major species” and “minor species” that are identical to the definitions of those terms found in FDA's regulations for new animal drugs for minor use and minor species (21 CFR 516.3). We are revising the feed drug category definitions in § 558.3 to preserve the availability of medicated feeds intended for use in minor species and prevent a Start Printed Page 57799likely disincentive for development of additional therapies for minor species.
FDA has determined that the subject of this rulemaking is suitable for a direct final rule. FDA is amending § 558.3(b)(1) by revising the definitions of Category I and Category II new animal drugs administered in or on medicated feed. This rule is intended to make noncontroversial changes to existing regulations. The Agency does not anticipate receiving any significant adverse comments on this rule.
Comments that are frivolous, insubstantial, or outside the scope of this direct final rule will not be considered significant or adverse under this procedure. For example, a comment recommending a regulation change in addition to those in the rule would not be considered a significant adverse comment unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to an amendment, paragraph, or section of this rule and that provision can be severed from the remainder of the rule, FDA may adopt as final those provisions of the rule that are not the subject of a significant adverse comment.
If FDA withdraws the direct final rule, all comments received will be considered under the companion proposed rule in developing a final rule under the usual notice-and-comment procedures under the APA (5 U.S.C. 552 et seq.). If FDA does not receive a significant adverse comment in response to the direct final rule, the Agency will publish, within 30 days after the comment period ends, a document in the Federal Register confirming the effective date of the final rule. The Agency intends to make the direct final rule effective December 1, 2016.
We are issuing these regulations under the legal authority provided by section 512 of the FD&C Act relating to new animal drugs and section 701(a) of the FD&C Act. Section 512 gives FDA the authority to approve new animal drug applications (NADAs). Such approval establishes conditions of use under which the drug can be used in a safe and effective manner. Categorization of new animal drugs used in medicated feeds is one such condition of use. In addition, section 701(a) of the FD&C Act gives FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this direct final rule would not impose any compliance costs on the sponsors of animal drug products that are currently marketed or in development, we certify that this direct final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “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 $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This direct final rule would not result in an expenditure in any year that meets or exceeds this amount.
This direct final rule allows certain new animal drugs approved for use in animal feed that would otherwise be recategorized as Category II drugs under the current definitions in § 558.3 following withdrawal of approval of production indications during GFI #213 implementation to remain in Category I if the change to Category II would have been triggered by a minor species indication.
Based on the revised definitions of the two feed drug categories, there is one drug, sulfamerazine for control of furunculosis in trout (21 CFR 558.582), that will be recategorized from Category II to Category I as a result of this direct final rule. No compliance costs will be incurred due to this recategorization because no changes to the approved application are required for continued marketing of the drug.
We have 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.Start Printed Page 57800
We have analyzed this direct final rule in accordance with the principles set forth in Executive Order 13132. We have determined that this direct final rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have concluded that this direct final rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.
Therefore, under the 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:
2. In § 558.3, revise paragraphs (b)(1)(i) and (ii); and add paragraphs (b)(13) and (14) to read as follows:
[FR Doc. 2016-20148 Filed 8-23-16; 8:45 am]