[Federal Register Volume 74, Number 204 (Friday, October 23, 2009)]
[Proposed Rules]
[Pages 54771-54773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25518]


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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:  Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
the regulations regarding new animal drug applications (NADAs). 
Specifically, this proposed rule is being issued to provide that NADAs 
shall be submitted in the form and containing the information 
described, 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. This proposed rule is a companion document to the 
direct final rule published elsewhere in this issue of the Federal 
Register.

DATES: Submit written comments on or before January 6, 2010. If FDA 
receives any significant adverse comments, the agency will publish a 
document withdrawing the direct final rule within 30 days after the 
comment period ends. FDA will then proceed to respond to comments under 
this proposed rule using the usual notice and comment procedures.

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 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.
    To ensure more timely processing of comments, FDA is no longer 
accepting

[[Page 54772]]

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 proposed rule is being issued to amend Sec.  514.1 (21 CFR 
514.1) so as to provide that NADAs shall contain 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 proposed 
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. 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 finalize the rule in the event that a 
significant adverse comment is received in response to the direct final 
rule and it 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. If no 
significant adverse comment is received in response to the direct final 
rule, no further action will be taken related to this proposed rule. 
Instead we will publish a document confirming the effective date within 
30 days after the comment period ends, confirming when the direct final 
rule will go into effect.
    If we receive any significant adverse comment regarding the direct 
final rule, 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 under the Administrative Procedures Act (APA) (5 
U.S.C. 552a et seq.). The comment period for this companion proposed 
rule runs concurrently with the comment period for the direct final 
rule. Any comments received under this companion proposed rule will 
also be considered as comments regarding the direct final rule, and 
vice versa. We will not provide additional opportunity for comment.
    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 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 APA (5 U.S.C. 553). Comments that are 
frivolous, insubstantial, or outside the scope of the rule will not be 
considered adverse under this procedure. For example, a comment 
recommending an additional change to the rule will not be considered a 
significant 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.
    In the Federal Register of November 21, 1997 (62 FR 62466), you can 
find additional information about FDA's direct final rulemaking 
procedures in 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.

III. Legal Authority

    FDA's authority to issue this proposed 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 proposed 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 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 (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 proposed 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 proposed rule would not impose any 
direct or indirect costs on industry or government through the 
amendment, but rather

[[Page 54773]]

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 proposes to certify that the 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 $133 million, using the most current (2008) 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 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 proposed rule refers to previously approved collections of 
information found in FDA regulations. The proposed rule would amend 
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.

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.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 514 be amended as follows:

PART 514--NEW ANIMAL DRUG APPLICATIONS

    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.
    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. E9-25518 Filed 10-22-09; 8:45 am]
BILLING CODE 4160-01-S