[Federal Register Volume 79, Number 51 (Monday, March 17, 2014)]
[Proposed Rules]
[Pages 14630-14632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05432]



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: Proposed rule.


SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing 
to amend its regulation regarding the confidentiality of data and 
information in and about new animal drug application files to change 
when certain approval-related information would be disclosed by the 
Agency. This change would ensure that the Agency is able to update its 
list of approved new animal drug products within the statutory 
timeframe. It would 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: Submit either electronic or written comments by June 2, 2014. If 
FDA receives any significant adverse comments, the Agency will publish 
a document in the Federal Register 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-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(s), 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.


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

[[Page 14631]]

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.
    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 
    FDA is proposing to amend Sec.  514.11 to change the time when 
certain approval-related information in an NADA file would be publicly 
disclosed, from when notice of the approval is published in the Federal 
Register to when the application is approved. This change would 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 
would also permit more timely public disclosure of certain approval-
related information following sponsor notification of application 
approval, increasing the transparency of Agency decision making in the 
approval of new animal drugs.

II. Companion Document to Direct Final Rulemaking

    This proposed rule is a companion to the direct final rule 
published elsewhere in this issue of the Federal Register. FDA proposes 
to amend Sec.  514.11 to change the time when certain approval-related 
information in an NADA file would be publicly disclosed to ensure that 
the Agency is able to update the ``Green Book'' within the 30-day 
statutory time frame. This proposed 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 
direct final rule. The direct final rule and this companion proposed 
rule are substantively identical. This 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 proposed rule runs 
concurrently with the comment period of the companion direct final 
rule. Any comments received in response to the companion direct final 
rule will also be considered as comments regarding this proposed rule.
    FDA is providing a comment period for the proposed rule of 75 days 
after the date of publication in the Federal Register. If FDA receives 
a significant adverse comment, we intend to withdraw the 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 proposed 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 proposed rule would not be considered a 
significant adverse comment unless the comment states why the proposed 
rule would be ineffective without the additional change. In addition, 
if a significant adverse comment applies to an amendment, paragraph, or 
section of this proposed rule and that provision can be severed from 
the remainder of the rule, FDA may adopt as final those provisions of 
the proposed rule that are not the subject of a significant adverse 
    If FDA does not receive significant adverse comment in response to 
the proposed 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 proposed 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 proposed 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 proposed 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

[[Page 14632]]

significant impact of a rule on small entities. Because this proposed 
rule would not impose any compliance costs on sponsors of animal drug 
products that are currently marketed or in development, the Agency 
proposes to certify that the proposed rule if finalized would not have 
a significant economic impact on a substantial number of small 
    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 
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 proposed rule, if finalized, would 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 tentatively concludes that the proposed 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 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 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, it is 
proposed that 21 CFR part 514 be amended as follows:


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

    Authority: 21 U.S.C. 321, 331, 351, 352, 356a, 360b, 371, 379e, 
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. 2014-05432 Filed 3-14-14; 8:45 am]