[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