[Federal Register Volume 79, Number 51 (Monday, March 17, 2014)]
[Rules and Regulations]
[Pages 14609-14611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05430]



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 Rules and Regulations
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  Federal Register / Vol. 79, No. 51 / Monday, March 17, 2014 / Rules 
and Regulations  

[[Page 14609]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. FDA-2014-N-0108]


New Animal Drug Applications; Confidentiality of Data and 
Information in a New Animal Drug Application File

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulation regarding the confidentiality of data and information in and 
about new animal drug application files to change when certain 
approval-related information will be disclosed by the Agency. This 
change will ensure that the Agency is able to update its list of 
approved new animal drug products within the statutory timeframe. It 
will also permit more timely public disclosure of approval-related 
information, increasing the transparency of FDA decision making in the 
approval of new animal drugs.

DATES: This rule is effective July 30, 2014. Submit either electronic 
or written comments by June 2, 2014. 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-2014-
N-0108, 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:
     Mail/ Hand Delivery/ Courier (for paper 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 No. FDA-2014-N-0108 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: Scott Fontana, Center for Veterinary 
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0656.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 512(i) (21 U.S.C. 360b(i)) was added to the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) by the Animal Drug Amendments of 
1968 (Pub. L. 90-399). Section 512(i) requires the conditions and 
indications of use of a new animal drug to be published in the Federal 
Register upon approval of a new animal drug application (NADA) filed 
under section 512(b) of the FD&C Act.
    In 1974, FDA revised its regulations regarding the confidentiality 
of information in applications in Sec.  135.33a (21 CFR 135.33a) to 
include provisions of the Freedom of Information Act (Pub. L. 89-487). 
That revision established that public disclosure by the Agency of 
certain data and information in an NADA file could not occur before the 
Federal Register notice of approval published (39 FR 44653, December 
24, 1974). Shortly thereafter, Sec.  135.33a was redesignated as Sec.  
514.11 (21 CFR 514.11) (40 FR 13802 at 13825, March 27, 1975).
    In 1988, the Generic Animal Drug and Patent Term Restoration Act 
(Pub. L. 100-670) added section 512(n)(4)(A) of the FD&C Act, which 
states that the Agency shall publish a list of approved new animal drug 
products and revise that list every 30 days to include each new animal 
drug that has been approved during that 30-day period. This list, as 
well as related patent information and marketing exclusivity periods, 
is contained in a document generally known as the ``Green Book,'' 
available at the Agency's public Web site at http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts ApprovedAnimalDrugProducts.
    The editorial and clearance processes for publishing the Federal 
Register notice announcing the approval of an NADA varies from 1 to 2 
months after the approval letter is issued to the applicant. 
Consequently, the addition of newly approved product information to the 
``Green Book'' and public disclosure of certain other approval-related 
information at the Agency's public Web site is delayed until after that 
Federal Register notice is published. Such other approval-related 
information may include the summary of information forming the basis 
for approval (known also as the Freedom of Information Summary) and 
documentation of environmental review. Trade and proprietary 
information in the application file remains confidential and is not 
disclosed.
    FDA is issuing this direct final rule amending Sec.  514.11 to 
change the time when certain approval-related information in an NADA 
file will be publicly disclosed, from when notice of the approval is 
published in the Federal Register to when the application is approved. 
This change will ensure that the Agency is able to update the ``Green 
Book'' within the 30-day statutory timeframe (see section 
512(n)(4)(A)(ii) of the FD&C Act). It will also permit more timely 
public disclosure of certain approval-related information following 
sponsor notification of application approval, increasing the 
transparency of

[[Page 14610]]

Agency decision making in the approval of new animal drugs.

II. Direct Final Rulemaking

    FDA has determined that the subject of this rulemaking is suitable 
for a direct final rule. FDA is amending Sec.  514.11 to change the 
time when certain approval-related information in an NADA file will be 
publicly disclosed to ensure that the Agency is able to update the 
``Green Book'' within the 30-day statutory timeframe. This rule is 
intended to make noncontroversial changes to existing regulations. The 
Agency does not anticipate receiving any significant adverse comment on 
this rule.
    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 and this direct final rule 
are substantively identical. 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 for 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 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 
withdrawing a direct final rule, the Agency 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 direct final rule will not be considered significant or adverse 
under this procedure. For example, 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, FDA may adopt as final those provisions of the 
rule that are not the subject of a significant adverse comment.
    If FDA does not receive significant adverse comment in response to 
the direct final rule, the Agency will publish a document in the 
Federal Register confirming the effective date of the final rule. The 
Agency intends to make the direct final rule effective 30 days after 
publication of the confirmation document in the Federal Register.
    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 is issuing this direct final rule under section 512(c) of the 
FD&C Act. This section gives the Secretary of Health and Human Services 
the authority to approve new animal drug applications. 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.

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 this direct final rule under 
Executive Order 12866, Executive Order 13563, the Regulatory 
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform 
Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct 
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 direct 
final rule is not a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this direct final rule would not impose any 
compliance costs on the sponsors of animal drug products that are 
currently marketed or in development, the Agency certifies that this 
direct 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 $141 million, using the most current (2012) 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 direct final 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 concludes that the direct final 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 contains no collection of information. 
Therefore, clearance by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

VIII. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It

[[Page 14611]]

is only necessary to send one set of 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, and will be posted to 
the docket at http://www.regulations.gov.

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, 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.  514.11, revise paragraphs (b), (d), (e) introductory text, 
and (e)(2)(ii) introductory text to read as follows:


Sec.  514.11  Confidentiality of data and information in a new animal 
drug application file.

* * * * *
    (b) The existence of an NADA file will not be disclosed by the Food 
and Drug Administration before the application has been approved, 
unless it has been previously disclosed or acknowledged.
* * * * *
    (d) If the existence of an NADA file has been publicly disclosed or 
acknowledged before the application has been approved, no data or 
information contained in the file is available for public disclosure, 
but the Commissioner may, in his discretion, disclose a summary of such 
selected portions of the safety and effectiveness data as are 
appropriate for public consideration of a specific pending issue, i.e., 
at an open session of a Food and Drug Administration advisory committee 
or pursuant to an exchange of important regulatory information with a 
foreign government.
    (e) After an application has been approved, the following data and 
information in the NADA file are immediately available for public 
disclosure unless extraordinary circumstances are shown:
* * * * *
    (2) * * *
    (ii) For an NADA approved after July 1, 1975, a summary of such 
data and information prepared in one of the following two alternative 
ways shall be publicly released when the application is approved.
* * * * *

    Dated: March 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05430 Filed 3-14-14; 8:45 am]
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