
[Federal Register: October 23, 2009 (Volume 74, Number 204)]
[
Rules and Regulations]               
[Page 54749-54751]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc09-2]                         

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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: urvi.desai@fda.hhs.gov.



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



[[Page 54751]]



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]

BILLING CODE 4160-01-S
