SUPPLEMENTARY INFORMATION:

I. Supplemental Approval of Revised Labeling and Withdrawal of Approval of Portions of NADAs Pertaining to Production Indications

FDA is amending the animal drug regulations to reflect approval of eight supplemental NADAs for revised labeling reflecting a change in marketing status from OTC use to use by VFD for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for production indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed.

These applications were identified as being affected by guidance for industry (GFI) #213, “New Animal Drugs and ( printed page 11511) New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209”, December 2013 ( http://www.fda.gov/​downloads/​AnimalVeterinary/​GuidanceComplianceEnforcement/​GuidanceforIndustry/​UCM299624.pdf). Their change from OTC to VFD marketing status is consistent with FDA CVM's initiative for the Judicious Use of Antimicrobials.

The affected applications for Type A medicated articles for which supplemental applications with revised labeling were approved are as follows:

The affected applications for manufacturing combination drug medicated feeds follow:

II. Withdrawals of Approval

At the sponsors' requests, approval of applications is being withdrawn for medicated feeds containing antimicrobial drugs of importance to human medicine administered to food-producing animals because these products are no longer manufactured or marketed. The applications being withdrawn are as follows:

Elsewhere in this issue of the Federal Register , FDA gave notice that approval of NADAs 044-820, 044-972, 047-261, 047-262, 048-954, 091-513, 092-482, 093-106, 101-689, 122-481, 122-608, 122-822, 137-537, 138-792, 138-828, 138-904, 141-110, and 141-150, and ANADAs 200-092 and 200-093, and all supplements and amendments thereto, is withdrawn, effective February 24, 2017. As provided in the regulatory text of this document, the animal drug ( printed page 11512) regulations are amended to reflect these voluntary withdrawals of approval.

A similar rule published in the Federal Register of December 27, 2016 (81 FR 94991), amended the approved conditions of use in 21 CFR part 558 to reflect approval of an additional 106 supplemental NADAs and supplemental ANADAs for the manufacture of medicated feeds for administration of antimicrobial drugs to food-producing animals and the voluntary withdrawal of approval of 11 NADAs and 4 ANADAs.

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.

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:

1. The authority citation for part 558 continues to read as follows:

Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

2. In § 558.450, redesignate paragraph (e)(4)(iii) as paragraph (e)(4)(v) and add paragraphs (e)(4)(iii) and (iv) to read as follows:

3. In § 558.635, revise paragraphs (a) and (e) and add paragraphs (d)(1) and (2) to read as follows: