
[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Rules and Regulations]
[Pages 11664-11665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04945]



[[Page 11664]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2003-N-0446 (formerly 2003N-0324)]


New Animal Drugs for Use in Animal Feeds; Removal of Obsolete and 
Redundant Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is removing regulations 
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. FDA has other strategies for assessing the safety of 
antimicrobial new animal drugs with regard to their microbiological 
effects on bacteria of human health concern, and the only remaining 
animal drug use listed in these regulations is now listed elsewhere in 
the new animal drug regulations.

DATES: This rule is effective April 6, 2016.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule into 
the ``Search'' box and follow the prompts, and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for 
Veterinary Medicine (HFV-1), 7519 Standish Pl., Rockville, MD 20855, 
240-402-5704, email: william.flynn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

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 
(Sec.  558.15), on the grounds that these regulations were obsolete or 
redundant. The proposed rule explained the nature and purpose of Sec.  
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 of this chapter.
    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 Sec.  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.
    The Agency received only one set of comments on the 2003 proposed 
rule, from Pennfield Oil Co. (Pennfield). At that time, Pennfield was 
the sponsor of NADA 141-137, a bacitracin methylene disalicylate (BMD) 
Type A medicated article that is listed in the table in Sec.  
558.15(g)(1). In the table, the listing is under Fermenta Animal Health 
Co., which was a predecessor in interest to Pennfield. In response to 
the NOOH, Pennfield submitted a hearing request regarding this product. 
In its comments on the 2003 proposed rule, Pennfield objected to the 
removal of Sec.  558.15 until the issues in the NOOH were addressed. It 
argued that the BMD listing in Sec.  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. Pharmgate LLC (Pharmgate) is the current sponsor of NADA 
141-137 (80 FR 13226, March 13, 2015).
    For the eight other products and use combinations subject to the 
NOOH, FDA received supplemental applications with labeling conforming 
to the relevant findings of effectiveness. FDA approved those 
applications in 2006 and 2009 and amended part 558 subpart B to reflect 
those approvals (71 FR 16222 (March 31, 2006); 71 FR 16223 (March 31, 
2006); and 74 FR 40723 (August 13, 2009)). Subsequent to those 
approvals, FDA finalized portions of the 2003 proposed rule by removing 
from the tables in Sec.  558.15(g) the products and use combinations 
that were not approved, and the products and use combinations whose 
approval was reflected in part 558, subpart B (71 FR 16219 (March 31, 
2006) and 75 FR 16001 (March 31, 2010)). FDA retained only the listing 
in the table in Sec.  558.15(g)(1) relating to NADA 141-137 as well as 
Sec.  558.15(a) through (f). In both the 2006 and 2010 final rules, FDA 
stated it intended to continue to finalize the proposed rule to remove 
all of Sec.  558.15.
    Recently, Pharmgate filed a supplemental application to NADA 141-
137 which provided labeling conforming to the relevant findings of 
effectiveness announced in the NOOH. FDA approved this supplement on 
October 6, 2015. Also on October 6, 2015, Pharmgate withdrew the 
hearing request relating to NADA 141-137. FDA has since published in 
the Federal Register a notice amending Sec.  558.76 of subpart B to 
reflect this supplemental approval (80 FR 79474, December 22, 2015).
    Because the approval of NADA 141-137 is now listed in Sec.  558.76 
of subpart B, FDA is removing its associated listing in Sec.  
558.15(g)(1) as obsolete. In addition, FDA is finalizing the proposed 
rule by removing all of the other remaining portions of Sec.  558.15 
because they are also obsolete. A conforming change is made in Sec.  
558.4.

II. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-602), and the 
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 
12866 directs us 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). We believe that this 
final rule is not a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options to minimize any significant impact on a substantial number of 
small entities. We have 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. Therefore, FDA certifies that 
the 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 proposing ``any rule that may 
result in an annual expenditure by State, local and tribal

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governments, in the aggregate, or by the private sector, of $100 
million (adjusted annually for inflation) in any one year.'' The 
current threshold after adjustment for inflation is $144 million, using 
the most current (2014) Implicit Price Deflator for the Gross Domestic 
Product. This final rule would not result in any 1-year expenditure 
that meets or exceeds this amount.
    FDA proposed the removal of Sec.  558.15 on August 8, 2003, because 
it was obsolete or redundant. The original purpose of Sec.  558.15 was 
to require 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. FDA determined that this section 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 removes the only remaining 
animal drug use listed in Sec.  558.15(g), which is obsolete since 
approval of its NADA is now listed elsewhere in part 558.
    Only one set of comments to the proposal was received by FDA. Since 
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 
Sec.  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.
    We do not expect the final rule that revokes the remaining portions 
of Sec.  558.15 to have a substantive effect on any approved new animal 
drug or to cause any approved new animal drug to lose its marketing 
ability or experience a loss of sales.

III. Analysis of Environmental Impact

    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.

IV. Paperwork Reduction Act

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

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, 21 CFR part 
558 is amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
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.


Sec.  558.4  [Amended]

0
2. In paragraph (c) of Sec.  558.4, remove ``and in Sec.  558.15 of 
this chapter''.


Sec.  558.15  [Removed]

0
3. Remove Sec.  558.15.

    Dated: March 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04945 Filed 3-4-16; 8:45 am]
BILLING CODE 4164-01-P


