
[Federal Register: October 23, 2009 (Volume 74, Number 204)]
[
Proposed Rules]               
[Page 54771-54773]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc09-15]                         

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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: urvi.desai@fda.hhs.gov.



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
