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 Pharmgate, as successor to Pennfield, has since withdrawn the hearing request for NADA 141-137.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.

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 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: