[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Rules and Regulations]
[Pages 69586-69588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28550]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 516

[Docket No. FDA-2010-N-0534]


New Animal Drugs for Minor Use and Minor Species

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations regarding new animal drugs for minor use and minor species 
to update language and to clarify the regulations consistent with the 
explanations in the preambles to the proposed and final rules 
establishing them. This action is being taken to ensure accuracy and 
clarity in the Agency's regulations.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a companion proposed rule, under FDA's usual procedure for notice-and-
comment rulemaking, to provide a procedural framework to finalize the 
rule in the event the Agency receives any significant adverse comments 
and withdraws this direct final rule. The companion proposed rule and 
direct final rule are substantively identical.

DATES: This rule is effective March 30, 2011. Submit either electronic 
or written comments by January 31, 2011. If FDA receives no significant 
adverse comments within the specified comment period, the Agency will 
publish a document confirming the effective date of the final rule in 
the Federal Register within 30 days after the comment period on this 
direct final rule ends. If timely significant adverse comments are 
received, the Agency will publish a document in the Federal Register 
withdrawing this direct final rule before its effective date.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0534, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and docket number for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: 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 document, 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:  Meg Oeller, Center for Veterinary 
Medicine (HFV-50), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-9005.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Minor Use and Minor Species Animal Health Act of 2004 amended 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish 
new regulatory procedures that provide incentives intended to make more 
drugs legally available to veterinarians and animal owners for the 
treatment of minor animal species and uncommon diseases in major animal 
species. FDA published the final rule to implement these regulations 
(part 516 (21 CFR part 516)) in the Federal Register of July 26, 2007 
(72 FR 41010).
    FDA is issuing this direct final rule to amend its regulations 
regarding new animal drugs for minor use and minor species (MUMS) in 
part 516 to update language and clarify the intent of the regulations 
consistent with the preambles to the proposed and final rules.
    In Sec.  516.3(b), FDA is amending the definition of ``Same dosage 
form'' to make it clearer that the six dosage form categories listed in 
the regulations under Sec.  516.3(b)(i) through (b)(vi) are the 
``categories'' of dosage forms that the preamble to the proposed rule 
referenced as follows: ``The second test of sameness which the statute 
establishes to determine eligibility of an animal drug for designation 
is `same dosage form.' The agency proposes to

[[Page 69587]]

use the long-established dosage form categories listed in Title 21 of 
the Code of Federal Regulations to implement this statutory 
requirement'' (70 FR 56394 at 56398, September 27, 2005). To accomplish 
this clarification, the amendment will add the word ``categories'' 
after the phrase ``dosage forms'' and remove the ``s'' from ``forms'' 
in the first sentence of the definition.
    Section 516.20(b)(2) requires that requests for MUMS designation 
include ``* * * the generic and trade name, if any, of the drug * * *'' 
intended to be designated and FDA is amending this language to replace 
the terms ``generic'' and ``trade'' with the terms ``established'' and 
``proprietary'', respectively, because the latter are the terms used in 
the FD&C Act (see section 502(e) (21 U.S.C. 352(e)). FDA is also 
revising this language to clarify that ``drug'' in the context of Sec.  
516.20(b)(2) refers to the ``active pharmaceutical ingredient (API)'' 
name rather than to a formulated drug product name. The purpose of the 
information required in this provision of the regulation is to permit 
the Agency to determine whether a drug is eligible for designation on 
the basis that it is not the ``same drug'' as a drug that is already 
designated, conditionally approved, or approved (see section 
573(a)(2)(B) of the FD&C Act (21 U.S.C. 360ccc-2)) and, because the 
definition of ``same drug'' in Sec.  516.3(b) requires a knowledge of 
the drug's ``active moiety'' in order to make this determination, a 
request for MUMS designation needs to include the API name. This is 
because the API name includes the active moiety and the drug product 
name normally does not. FDA is also clarifying the relationship between 
established and proprietary names in this context with the use of 
parentheses.

II. Direct Final Rulemaking

    FDA has determined that the subject of this rulemaking is suitable 
for a direct final rule. FDA is revising part 516 by updating language 
and clarifying its intent. This rule is intended to make 
noncontroversial changes to existing regulations. The Agency does not 
anticipate receiving any significant adverse comment on this rule.
    Consistent with FDA's procedures on direct final rulemaking, we are 
publishing elsewhere in this issue of the Federal Register a companion 
proposed rule. The companion proposed rule provides the procedural 
framework within which the rule may be finalized in the event the 
direct final is withdrawn because of any significant adverse comment. 
The comment period for this direct final rule runs concurrently with 
the comment period of the companion proposed rule. Any comments 
received in response to the companion proposed rule will also be 
considered as comments regarding this direct rule.
    FDA is providing a comment period on the direct final rule of 75 
days after the date of publication in the Federal Register. If FDA 
receives any significant adverse comment, we intend to withdraw this 
direct final rule before its effective date by publication of a notice 
in the Federal Register within 30 days after the comment period ends. A 
significant adverse comment is one that explains why the rule would be 
inappropriate, including challenges to the rule's underlying premise or 
approach, or would be ineffective or unacceptable without a change. In 
determining whether an adverse comment is significant and warrants 
withdrawing a direct final rule, we will consider whether the comment 
raises an issue serious enough to warrant a substantive response in a 
notice-and-comment process in accordance with section 553 of the 
Administrative Procedure Act (5 U.S.C. 553). A comment recommending a 
rule change in addition to this rule will not be considered a 
significant adverse comment unless the comment also states why this 
rule would be ineffective without the additional change.
    If FDA does not receive significant adverse comment, the Agency 
will publish a document in the Federal Register confirming the 
effective date of the final rule. The Agency intends to make the direct 
final rule effective 30 days after publication of the confirmation 
document in the Federal Register.
    A full description of FDA's policy on direct final rule procedures 
may be found in a guidance document published in the Federal Register 
of November 21, 1997 (62 FR 62466). The guidance document may be 
accessed at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.

III. Legal Authority

    FDA's authority to issue this direct final rule is provided by 
section 512(b)(1) of the FD&C Act (21 U.S.C. 360b(b)(1)). This section 
states that any person may file with the Secretary of Health and Human 
Services an application with respect to any intended use or uses of a 
new animal drug and sets forth the specific information that must be 
included in such an application. In addition, section 701(a) of the 
FD&C Act (21 U.S.C. 371(a)) gives FDA general rulemaking authority to 
issue regulations for the efficient enforcement of the FD&C Act. FDA is 
issuing this direct final rule under these authorities.

IV. Environmental Impact

    FDA 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.

V. 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. 601-612), 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). The Agency believes that 
this final rule is not a significant regulatory action under the 
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this direct final rule would not impose any 
compliance costs on the sponsors of animal drug products that are 
currently marketed or in development, the Agency certifies that the 
direct final rule will not have a significant economic impact on a 
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 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 $135 million, using the most current (2009) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
direct final rule to result in any 1-year expenditure that would meet 
or exceed this amount.

VI. Federalism

    FDA has analyzed this direct final rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the direct final rule

[[Page 69588]]

does not contain policies that have substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the Agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

VII. Paperwork Reduction Act of 1995

    This direct final rule contains information collection provisions 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information addressed in the direct final 
rule have been approved by OMB in accordance with the PRA under the 
regulations governing designation of new animal drugs for MUMS (part 
516, OMB control number 0910-0605). Thus, Sec.  516.20 as amended, does 
not constitute a new or additional paperwork burden requiring OMB 
approval.

VIII. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.


0
Therefore under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
516 is amended as follows:

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
1. The authority citation for 21 CFR part 516 continues to read as 
follows:

    Authority:  21 U.S.C. 360ccc-1, 360ccc-2, 371.

0
2. Amend Sec.  516.3(b) by revising the introductory text of the 
definition of ``Same dosage form'' to read as follows:


Sec.  516.3  Definitions.

* * * * *
    (b) * * *
    Same dosage form means the same as one of the dosage form 
categories specified in the following parts of this chapter:
* * * * *

0
3. Amend Sec.  516.20 by revising paragraph (b)(2) to read as follows:


Sec.  516.20  Content and format of a request for MUMS-drug 
designation.

* * * * *
    (b) * * *
    (2) The name and address of the sponsor; the name of the sponsor's 
primary contact person and/or permanent-resident U.S. agent including 
title, address, and telephone number; the established name (and 
proprietary name, if any) of the active pharmaceutical ingredient of 
the drug; and the name and address of the source of the active 
pharmaceutical ingredient of the drug.
* * * * *

    Dated: November 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-28550 Filed 11-12-10; 8:45 am]
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