[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Proposed Rules]
[Pages 69614-69616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28551]


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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
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. This proposed rule is a companion 
document to the direct final rule published elsewhere in this issue of 
the Federal Register.

DATES: Submit electronic or written comments by January 31, 2011.

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

[[Page 69615]]

Electronic Submissions

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

Written Submissions

    Submit written submissions in the following ways:
    <bullet> FAX: 301-827-6870.
    <bullet> 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(s), 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 proposing 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 proposing to amend 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 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 proposing to amend 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 proposing to revise 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 proposing to 
clarify the relationship between established and proprietary names in 
this context with the use of parentheses.

II. Companion Document to Direct Final Rulemaking

    This proposed rule is a companion to the direct final rule 
published in the final rules section of this issue of the Federal 
Register. The direct final rule and this companion proposed rule are 
substantively identical. This companion proposed rule provides the 
procedural framework to proceed with standard notice-and-comment 
rulemaking if the direct final rule receives significant adverse 
comment and is withdrawn. FDA is publishing the direct final rule 
because we believe the rule is non-controversial and we do not 
anticipate receiving any significant adverse comments.
    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 terminating a direct final rulemaking, 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). 
Comments that are frivolous, insubstantial, or outside the scope of the 
rule will not be considered significant or adverse under this 
procedure. A comment recommending a regulation change in addition to 
those in the rule would not be considered a significant adverse comment 
unless the comment states why the rule would be ineffective without the 
additional change. In addition, if a significant adverse comment 
applies to an amendment, paragraph, or section of this rule and that 
provision can be severed from the remainder of the rule, we may adopt 
as final those provisions of the rule that are not the subject of a 
significant adverse comment. The comment period for the companion 
proposed rule runs concurrently with the comment period of the direct 
final rule. Any comments received on this companion proposed rule will 
also be treated as comments on the direct final rule. We will not 
provide additional opportunity for comment.
    If no significant adverse comment is received in response to the 
direct final rule, no further action will be taken related to this 
companion proposed rule. Instead, we will publish a document confirming 
the effective date within 30 days after the comment period ends, and we 
intend the direct final rule to become effective 30 days after 
publication of the confirmation notice.
    If we receive any significant adverse comments, we will withdraw 
the direct final rule within 30 days after the comment period ends and 
proceed to respond to all of the comments under this companion proposed 
rule using usual notice-and-comment rulemaking procedures. The Agency 
will address the comments in a subsequent final rule.

[[Page 69616]]

    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 proposed 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 proposed 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 proposed 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 proposed rule is not a significant regulatory action as defined by 
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 proposed rule would not impose any 
compliance costs on the sponsors of animal drug products that are 
currently marketed or in development, the Agency proposes to certify 
that the 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 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.

VI. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
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 tentatively concludes that the proposed 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 proposed 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 this proposed 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.

    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

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

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

    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:
* * * * *
    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. 2010-28551 Filed 11-12-10; 8:45 am]
BILLING CODE 4160-01-P