[Federal Register Volume 71, Number 62 (Friday, March 31, 2006)]
[Rules and Regulations]
[Pages 16219-16221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3121]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558

[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 regulations 
that exempted certain new animal drugs administered in feed from batch 
certification requirements. FDA is also 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. The intended effect of this rule is 
to remove regulations that are obsolete or redundant. The portions of 
the latter regulation that are being removed are most of the Type A 
medicated articles and use combinations that are listed in the tables 
contained in that regulation. This rule does not finalize the 
provisions of the proposed rule regarding removing the remainder of 
that regulation.

DATES: This rule is effective May 1, 2006.

FOR FURTHER INFORMATION CONTACT: Andrew J. Beaulieu, Center for 
Veterinary Medicine (HFV-50), 7519 Standish Pl., Rockville, MD 20855, 
240-276-9090, email: andrew.beaulieu[comma]fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 8, 2003 (68 FR 47272), FDA 
published a proposed rule to remove and reserve 21

[[Page 16220]]

CFR 510 Subpart F--Animal Use Exemptions From Certification and 
Labeling Requirements (part 510), consisting of Sec.  510.515 Animal 
feeds bearing or containing new animal drugs subject to the provisions 
of section 512(n) of the act (Sec.  510.515), and 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. Sec.  
510.515 and 558.15. It also explained that most of the products and use 
combinations subject to the listings in Sec.  558.15 had approvals that 
were already codified in part 558 subpart B. It described three 
categories of products and use combinations subject to the listings in 
Sec.  558.15 that did not have approvals codified in part 558 subpart 
B.
    The first category consisted of nine products and use combinations 
that were approved but which were subject to the Drug Efficacy Study 
Implementation (DESI) program. In the same issue of the Federal 
Register as the proposed rule, FDA published a notice of opportunity 
for hearing (NOOH), which announced the agency's findings of 
effectiveness for these products and use combinations (68 FR 47333). 
The agency proposed to withdraw the new animal drug applications 
(NADAs) for those products and 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. For applications proposed to be withdrawn, the agency 
provided an opportunity for hearing. In response to the NOOH, FDA 
received supplemental applications for seven of the products and use 
combinations with labeling conforming to the relevant findings of 
effectiveness. FDA has approved those applications and, elsewhere in 
this issue of the Federal Register, FDA is publishing final rules 
amending part 558 subpart B to reflect those approvals. FDA received 
hearing requests for the other two products.
    In the second category was one use combination that was approved 
but was not subject to the agency's DESI program. In the same issue of 
the Federal Register as the proposed rule, FDA issued a final rule 
amending part 558 subpart B to reflect this approval (68 FR 47237).
    The third category contained five use combinations the agency 
believed were not approved and, therefore, were erroneously listed in 
Sec.  558.15. The proposed rule stated that the agency was unaware of 
any company that currently marketed any of these use combinations, and 
requested that if a company wished to market one of them then it should 
present evidence supporting approval to avoid facing potential 
regulatory action in the event of future marketing. To date, no company 
has asserted that it holds a valid approval for them.

II. Comments on the Proposed Rule and Summary of the Final Rule

    The agency received only one set of comments on the proposed rule, 
from Pennfield Oil Co. (Pennfield). Pennfield owns 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. Pennfield also owns an oxytetracycline/neomycin Type A 
medicated article, NADA 138-939, that is listed in the table in Sec.  
558.15(g)(2). In response to the NOOH, FDA received hearing requests 
regarding both of these products.

A. Removal of Sec.  510.515

    The comment agreed with the agency's position that Sec.  510.515 is 
obsolete and stated that it did not oppose the removal of this 
provision. Thus, there were no opposing comments and, for the reasons 
described in the proposed rule, FDA is removing part 510 subpart F. FDA 
is also making a conforming change in Sec.  558.4 Requirement of a 
medicated feed mill license.

B. Removal of Sec.  558.15

    The comment objected to 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.
    FDA agrees that it should, at this time, maintain the listing for 
Pennfield's BMD Type A medicated article in Sec.  558.15.
    FDA is aware of only two approved new animal drugs for use in 
animal feeds that are not listed in part 558 subpart B--Pennfield's BMD 
and oxytetracycline/neomycin Type A medicated articles. FDA has decided 
to maintain both of these listings in Sec.  558.15 until, as part of 
the DESI program, either their approvals are withdrawn or part 558 
subpart B has been amended to reflect their approvals.
    Thus, FDA is removing from the tables in Sec.  558.15(g) those 
products and use combinations that are not approved and those products 
and use combinations whose approval is reflected in part 558 subpart B. 
FDA is retaining only the listings for NADA 141-137 and NADA 138-939 in 
those tables. In addition, FDA is retaining Sec.  558.15(a) through (f) 
until all of the table listings are removed. FDA intends 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 
are withdrawn or part 558 subpart B has been amended to reflect their 
approvals.

III. 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.

IV. Analysis of Impacts

    FDA has 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 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). FDA believes that this 
final rule is consistent with the regulatory philosophy and principles 
identified in the Executive Order. In addition, the final rule is not 
an economically significant regulatory action as defined by the 
Executive Order and so is not subject to review under the Executive 
Order.
    FDA proposed the removal of Sec. Sec.  510.515 and 558.15 on August 
8, 2003, because they were obsolete or redundant. The purpose of Sec.  
510.515 was to provide exemption from certification and labeling 
requirements of certain drugs used in animal feeds. FDA had 
discontinued the practice of certifying antibiotic animal drugs, 
thereby rendering the regulation obsolete relative to its intended 
purpose. 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 
also obsolete as FDA had a new strategy and concept for assessing

[[Page 16221]]

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.

A. Benefits

    Only one set of comments to 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. Sec.  510.515 and 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

    The analysis of the proposed rule concluded that five combination 
uses would lose marketing ability as a result of the revocation of 
Sec.  558.15, and that our previous attempts to contact the three 
sponsors of these five drug combinations led us to conclude that these 
sponsors no longer market these combinations. This conclusion is 
reinforced now by the lack of public comments on these five drug 
combination uses. Therefore, we do not expect the final rule that 
revokes Sec.  558.15 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 to minimize any significant impact on a substantial 
number of 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. No further analysis 
is required under the Regulatory Flexibility Act (as amended).

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 may 
result in an annual expenditure by State, local and tribal 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 $115 million, using the 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. As such, no further analysis of anticipated costs and benefits 
is required by the Unfunded Mandates Reform Act.

V. Paperwork Reduction Act of 1995

    FDA concludes that this rule does not have information collection 
requirements.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 558

    Animal drugs, Animal feeds.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
510 and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

Subpart F--[Removed and Reserved]

0
2. Subpart F, consisting of Sec.  510.515, is removed and reserved.

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

0
3. The authority citation for 21 CFR part 558 continues to read as 
follows:

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


Sec.  558.4  [Amended]

0
4. In paragraph (c) of Sec.  558.4, remove ``Sec. Sec.  510.515 and 
558.15'' and add in its place ``Sec.  558.15''.


Sec.  558.15  [Amended]

0
5. Amend Sec.  558.15 as follows:
0
a. In the table in paragraph (g)(1), remove the entries for ``Pitman-
Moore, Inc.'', ``A. L. Laboratories, Inc'', ``Elanco Products Co'', 
``Sanofi Animal Health, Inc.'', ``The Upjohn Co'', ``Pfizer, Inc'', 
``Hoechst-Roussel Agri-Vet, Inc'', ``American Cyanamid Co., Fermenta 
Animal Health Co., Feed Specialties Co., Inc., Pfizer, Inc., PennField 
Oil Co., and VPO, Inc..'', ``Merck Sharp & Dohme Research Labs., and 
Solvay Veterinary, Inc.'', ``Pfizer, Inc., PennField Oil Co.'', 
``American Cyanamid Co'', ``Hoffman-La Roche, Inc'', ``Pfizer, Inc.'', 
``American Cyanamid Co. and Pfizer, Inc.'', and ``Boehringer Ingelheim 
Vetmedica, Inc..''; and under the ``Drug Sponsor'' column revise the 
entry for ``A.L. Laboratories, Inc., Fermenta Animal Health Co.'', to 
read ``Fermenta Animal Health Co.''; and
0
b. In the table in paragraph (g)(2), remove the entries for 
``Boehringer Ingelheim Vetmedica, Inc.'', ``American Cyanamid Co'', 
``The Upjohn Co.'', ``Pitman-Moore, Inc.'', ``Merck Sharp & Dohme 
Research Labs.'', ``A. L. Laboratories, Inc.'', ``Whitmoyer Labs, 
Inc'', and ``Elanco Products Co.''; and under the ``Drug sponsor'' 
column revise the entry for ``Pfizer, Inc., PennField Oil Co., and VPO, 
Inc.'' to read ``PennField Oil Co.''

    Dated: March 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-3121 Filed 3-30-06; 8:45 am]
BILLING CODE 4160-01-S