[Federal Register Volume 75, Number 61 (Wednesday, March 31, 2010)]
[Rules and Regulations]
[Pages 16001-16002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7108]


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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 Docket No. 2003N-0324)


New Animal Drugs; 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 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.

DATES: This rule is effective April 30, 2010.

FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for 
Veterinary Medicine (HFV-50), 7519 Standish Pl., Rockville, MD 20855, 
240-276-9090, e-mail: [email protected].

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 (21 CFR 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 (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 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.
    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 Sec.  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 Sec.  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 Sec.  
558.15 until the issues in the NOOH are 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.
    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 Sec.  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 Sec.  558.15(a) through (f). FDA stated it intended to 
finalize the proposed rule to remove all of Sec.  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 Sec.  558.455 of 
subpart B to reflect that approval (74 FR 40723, August 13, 2009).

[[Page 16002]]

    This oxytetracycline/neomycin use combination is listed in the 
table in Sec.  558.15(g)(2) and is the only use combination listed in 
this provision. Because this use combination's approval is now 
reflected in Sec.  558.455, FDA is removing Sec.  558.15(g)(2) as 
obsolete or redundant. As in the 2006 final rule, FDA is retaining the 
sole listing in the table in Sec.  558.15(g)(1) for NADA 141-137 as 
well as Sec.  558.15(a) through (f), and intends to continue to 
finalize the proposed rule to remove all of Sec.  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 Sec.  558.15 on August 8, 2003, because 
it was obsolete or redundant. The original purpose of Sec.  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 
Sec.  558.15(g)(2) which is redundant because its approved conditions 
of use are now listed in Sec.  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 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.

B. Compliance Costs

    We do not expect the final rule that revokes Sec.  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.

List of Subjects in 21 CFR Part 558

     Animal drugs, Animal feeds.

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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

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1. The authority citation for 21 CFR part 558 continues to read as 
follows:

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


Sec.  558.15  [Amended]

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

    Dated: March 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7108 Filed 3-30-10; 8:45 am]
BILLING CODE 4160-01-S