[Federal Register Volume 74, Number 204 (Friday, October 23, 2009)]
[Rules and Regulations]
[Pages 54749-54751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25517]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. FDA-2009-N-0436]


New Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulations regarding new animal drug applications (NADAs). 
Specifically, this direct final rule is being issued to provide that 
NADAs shall be submitted in the described form, as appropriate for the 
particular submission. Currently, the regulation requires that all 
NADAs contain the same informational sections and does not explicitly 
provide the appropriate flexibility needed to address the development 
of all types of new animal drug products. This amendment will allow the 
agency to appropriately review safety and effectiveness data submitted 
to support the approval of new animal drug products. FDA is amending 
the regulations in accordance with its direct final rule procedures.
    Elsewhere in this issue of the Federal Register, we are 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 
this direct final rule are substantively identical.

DATES: This rule is effective March 8, 2010. Submit written comments on 
or before January 6, 2010. 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-2009-
N-0436 by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:

[[Page 54750]]

     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.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously, in the ADDRESSES portion 
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No. 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 ``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: Urvi Desai, Center for Veterinary 
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8297, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    This direct final rule is being issued to amend Sec.  514.1 (21 CFR 
514.1) so as to provide that NADAs shall include the information 
described in the section, as appropriate for the particular submission. 
Currently, the regulation requires that all NADAs contain the same 
informational sections and does not explicitly provide the appropriate 
flexibility needed to address the development of all types of new 
animal drug products. This amendment will allow the agency to 
appropriately review safety and effectiveness data submitted to support 
the approval of new animal drug products. In addition, the amendment is 
similar to the current provisions of the human new drug application 
regulations at 21 CFR 314.50 and thus will make the new human and new 
animal drug regulations more consistent.

II. Direct Final Rulemaking

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA 
announced the availability of the guidance document entitled ``Guidance 
for FDA and Industry: Direct Final Rule Procedures.'' This guidance 
document may be accessed at http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm. FDA believes that this rule is appropriate for 
direct final rulemaking because it is intended to make non-
controversial changes to existing regulations. We anticipate no 
significant adverse comments. 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 rule 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 
final 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 defined as a comment 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 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 (APA) (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. For example, a comment recommending an additional change to 
the rule will 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 part of a rule and that part can be severed from the 
remainder of the rule, we may adopt as final those parts of the rule 
that are not the subject of a significant adverse comment.
    If any significant adverse comments are received during the comment 
period, FDA will publish, before the effective date of the direct final 
rule, a document withdrawing the direct final rule. If we withdraw the 
direct final rule, all comments received will be considered under the 
companion proposed rule in developing a final rule using the usual 
notice-and-comment procedures under the APA (5 U.S.C. 552 et seq.). If 
we receive no significant adverse comment during the specified comment 
period, we intend to publish a document in the Federal Register 
confirming the effective date within 30 days after the comment period 
ends.

III. Legal Authority

    FDA's authority to issue this direct final rule is provided by 
section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act (the 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 act (21 U.S.C. 371(a)) gives FDA 
general rulemaking authority to issue regulations for the efficient 
enforcement of the act. FDA is issuing this direct final rule under 
these authorities.

IV. Environmental Impact

    FDA has carefully considered the potential environmental impacts of 
this rule and 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 Economic Impacts

    FDA has examined the impacts of the direct 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 (Public Law 104-4). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory

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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 direct 
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 the direct final rule would not impose any 
direct or indirect costs on industry or government through the 
amendment, but rather would only clarify that sponsors must include in 
their applications the information described in Sec.  514.1 that is 
appropriate for their particular submission, the agency certifies that 
the direct final rule would 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 $133 million, using the most current (2008) 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 rule 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 refers to previously approved collections of 
information found in FDA regulations. The direct final rule amends 
these previously approved collections of information by clarifying that 
NADAs must contain the information appropriate for the particular 
submission. Further, this amendment is based upon the Center for 
Veterinary Medicine's previous experience with these submissions. Thus, 
Sec.  514.1 as amended, does not constitute a new or additional 
paperwork burden requiring Office of Management and Budget (OMB) 
approval.
    Collections of information are subject to review by OMB under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections 
of information in Sec.  514.1 have been approved under OMB Control No. 
0910-0032. This approval expires April 30, 2011. An agency may not 
conduct and a person is not required to respond to a collection of 
information unless it displays a valid OMB control number.

VIII. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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 514

    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 
514 is amended as follows:

PART 514--NEW ANIMAL DRUG APPLICATIONS

0
1. The authority citation for 21 CFR part 514 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 356a, 360b, 371, 379e, 
381.

0
2. In Sec.  514.1, revise the first sentence of paragraph (a) and the 
introductory text of paragraph (b) to read as follows:


Sec.  514.1  Applications.

    (a) Applications to be filed under section 512(b) of the act shall 
be submitted in the form and contain the information described in 
paragraph (b) of this section, as appropriate to support the particular 
submission. * * *
    (b) Applications for new animal drugs shall be submitted in 
triplicate and assembled in the manner prescribed by paragraph (b)(15) 
of this section, and shall include the following information, as 
appropriate to support the particular submission: * * *
* * * * *

    Dated: October 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25517 Filed 10-22-09; 8:45 am]
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