[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)]
[Rules and Regulations]
[Pages 52995-52997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18809]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. FDA-2016-N-1943]


New Animal Drug Applications; Contents of Notice of Opportunity 
for a Hearing; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
making technical corrections to its regulations for hearing procedures 
for denial of approval or withdrawal of approval of new animal drug 
applications. The Agency is taking this action to harmonize terminology 
and to improve the organization and clarity of the regulations.

DATES: This rule is effective August 11, 2016.

ADDRESSES: 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 final rule 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: Vernon Toelle, Center for Veterinary 
Medicine (HFV-234), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5637, [email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Background
II. Legal Authority
III. Effective Date
IV. Economic Analysis of Impacts
V. Analysis of Environmental Impact
VI. Paperwork Reduction Act of 1995
VII. Federalism

[[Page 52996]]

I. Background

    This regulation is intended to make technical amendments to Sec.  
514.200 (21 CFR 514.200) to harmonize the terminology with part 12 (21 
CFR part 12), as well as to update Sec.  514.200 in accordance with 
plain language principles to make it easier for the public to 
understand and follow.
    When the Agency issued procedural regulations for formal 
evidentiary public hearings, originally published in part 2 (21 CFR 
part 2) and later redesignated to part 12,\1\ we intended those 
provisions to apply to all formal evidentiary hearings on new product 
applications, including new animal drug applications. As explained in 
the proposed rule, once the specific provisions in 21 CFR parts 511 and 
514 relating to investigational and marketed new animal drugs were 
revised in the same way as their counterpart provisions relating to 
investigational and marketed new drugs, to refer to the new procedural 
provisions in part 2, the prior procedural provisions relating to 
hearings would be revoked.\2\
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    \1\ See 41 FR 51706, November 23, 1976, and 42 FR 4680, January 
25, 1977.
    \2\ See 40 FR 40682 at 40716, September 3, 1975.
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    Consequently, when part 12 was finalized, we revised the 
regulations specific to new animal drugs. These revisions included 
revoking certain provisions and revising 21 CFR 514.201 to state that 
hearings related to new animal drugs under section 512(d) and (e) of 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
360b(d) and (e)) shall be governed by part 12 of this chapter. However, 
when we made these revisions to part 514, we neglected to update Sec.  
514.200 to match the terminology used in part 12.
    Therefore, we are now revising Sec.  514.200 to make its language 
and terminology consistent with the language and terminology of the 
procedural regulations for hearings in part 12. Specifically, we are 
changing the references to ``administrative law judge'' in current 
Sec.  514.200 to the term ``presiding officer'', which is defined in 21 
CFR 10.3 \3\ and further explained in 21 CFR 12.60 as the presiding 
officer in a hearing will be the Commissioner, a member of the 
Commissioner's office to whom the responsibility for the matter 
involved has been delegated, or an administrative law judge qualified 
under 5 U.S.C. 3105. Since the term ``presiding officer'' is used 
throughout part 12, we are updating the language of Sec.  514.200 to 
use the same terminology. We are also updating the language in current 
Sec.  514.200 from ``written appearance'' to ``objections and request 
for a hearing'' since the latter terminology is used throughout part 
12. Finally, we are updating the language in Sec.  514.200 on the 
contents of the objections and request for hearing and the contents of 
the Commissioner's notice granting a hearing to match the language of 
part 12 and to make clear what is required. These updates will 
eliminate confusion that could be caused by use of different terms to 
refer to the same procedural requirements and allow the reader to 
obtain necessary information in one place. We anticipate these 
technical changes will make Sec.  514.200 easier for the public to 
understand and follow.
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    \3\ ``Presiding officer means the Commissioner or the 
Commissioner's designee or an administrative law judge appointed as 
provided in 5 U.S.C. 3105.''
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    Since we are revising Sec.  514.200 to harmonize the language and 
terminology with part 12, we are also taking this opportunity to update 
the language of Sec.  514.200 in accordance with the Plain Writing Act 
of 2010 (Pub. L. 111-274) and Executive Order 13563. The Plain Writing 
Act of 2010 requires that all Federal agencies use ``clear government 
communication that the public can understand and use.'' Executive Order 
13563 mandates that all regulations be ``accessible, consistent, 
written in plain language, and easy to understand.'' Therefore, we are 
eliminating gender-specific pronouns, passive voice, complicated 
sentence structure, and archaic language, and updating the language to 
make it more reader-friendly and accessible. We anticipate that these 
changes will make Sec.  514.200 clearer and easier to read. 
Additionally, we are updating the title of that section from ``Contents 
of notice of opportunity for a hearing'' to ``Notice of opportunity for 
hearing; notice of participation and requests for hearing; grant or 
denial of hearing'' because the latter title more accurately describes 
the type of information found in Sec.  514.200. The latter title also 
harmonizes with an analogous section for new drug applications in 21 
CFR 314.200.
    All of these corrections are nonsubstantive, technical amendments 
designed to harmonize the language and terminology of Sec.  514.200 
with the governing regulation on formal evidentiary public hearings in 
part 12 and to make the language of Sec.  514.200 easier for the public 
to understand and follow. We are taking this action as a part of our 
Retrospective Review Initiative \4\ to clarify and harmonize the 
regulations and to update the language in accordance with the Plain 
Writing Act of 2010 and Executive Order 13563.
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    \4\ See E.O. 13563, section 6.
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II. Legal Authority

    FDA is issuing these regulations under section 512(e) of the FD&C 
Act. This section gives the Secretary of Health and Human Services the 
authority to grant approval, deny approval, or withdraw approval of 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.
    Section 6 of Executive Order 13563 states that FDA is under a 
continuing obligation to review its existing regulations periodically 
to determine whether any such regulations should be modified, 
streamlined, expanded, or repealed to improve regulatory effectiveness 
and reduce public burden. The Plain Writing Act of 2010 mandates that 
all regulations be written in clear language that is easy for the 
public to understand and use.
    This rule makes technical amendments to Sec.  514.200 to harmonize 
the language and terminology with the governing regulation on 
administrative hearings in part 12 and to update the language in 
accordance with the Plain Writing Act of 2010 and Executive Order 
13563. Publication of this document constitutes final action on these 
changes under the Agency's original intent with respect to the hearing 
provisions for new animal drug applications. Therefore, for good cause, 
FDA finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and public 
comment are unnecessary.

III. Effective Date

    These regulations are effective upon publication.

IV. Economic Analysis of Impacts

    We have examined the impacts of the 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 us 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). We 
have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. We believe that this final rule 
is not a significant

[[Page 52997]]

regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because this rule is making only technical amendments, we 
certify that the final rule will not have a significant economic impact 
on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``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 $146 
million, using the most current (2015) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.

V. Analysis of Environmental Impact

    We have determined under 21 CFR 25.31(i) 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.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
FDA is not required to seek clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

VII. Federalism

    We have analyzed this 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, we conclude 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.

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 part 514 continues to read:

    Authority: 21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 371, 
379e, 381.


0
2. Revise Sec.  514.200 to read as follows:


Sec.  514.200  Notice of opportunity for hearing; notice of 
participation and requests for hearing; grant or denial of hearing.

    (a) The notice to the applicant of opportunity for a hearing on a 
proposal by the Commissioner to refuse to approve an application or to 
withdraw the approval of an application will be published in the 
Federal Register together with an explanation of the grounds for the 
proposed action. The notice will describe how to request a hearing. An 
applicant has 30 days after publication of the notice to request a 
hearing.
    (b) If the applicant fails to request a hearing within the 30-day 
timeframe, the Commissioner, without further notice, will publish a 
final order denying or withdrawing approval of the application.
    (c) If the applicant desires to request a hearing:
    (1) Within 30 days after publication of the notice of opportunity 
for hearing, the applicant must submit to the Division of Dockets 
Management written objections and a request for a hearing in accordance 
with Sec. Sec.  12.20 and 12.22. This request for a hearing must 
include each specific objection to the proposal on which a hearing is 
requested, together with a detailed description and analysis of the 
factual information (including all relevant clinical and other 
investigational data) the applicant will present in support of that 
objection. A request for a hearing may not rest upon mere allegations 
or denials or general descriptions of positions or contentions, but 
must set forth specific reliable evidence showing there is a genuine 
and substantial issue of fact that requires a hearing.
    (2) If the Commissioner determines upon review of the data and 
information submitted in the objections and request for a hearing that 
a hearing is not justified because no genuine and substantial issue of 
fact precludes the refusal to approve the application or the withdrawal 
of approval of the application (for example, the applicant has not 
identified any adequate and well-controlled clinical investigations to 
support the claims of effectiveness), the Commissioner will enter an 
order denying the hearing and stating the final findings and 
conclusions.
    (3) If the Commissioner determines upon review of the data and 
information submitted in the objections and request for a hearing that 
a hearing is justified, the Commissioner will publish a notice setting 
forth the following:
    (i) The regulation or order that is the subject of the hearing;
    (ii) A statement specifying any part of the regulation or order 
that has been stayed by operation of law or in the Commissioner's 
discretion;
    (iii) The parties to the hearing;
    (iv) The specific issues of fact for resolution at the hearing;
    (v) The presiding officer, or a statement that the presiding 
officer will be designated in a later notice; and
    (vi) The date, time, and place of the prehearing conference, or a 
statement that the date, time, and place will be announced in a later 
notice. However, in the case of a denial of approval, the hearing must 
not occur more than 90 days after expiration of the 30-day time period 
in which to request a hearing, unless the presiding officer and the 
applicant otherwise agree; and in the case of withdrawal of approval, 
the hearing will occur as soon as practicable.
    (d) The hearing will be open to the public; however, if the 
Commissioner finds that portions of the application which serve as a 
basis for the hearing contain information concerning a method or 
process entitled to protection as a trade secret, the part of the 
hearing involving such portions will not be public, unless the 
respondent so specifies in the request for a hearing.

    Dated: August 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18809 Filed 8-10-16; 8:45 am]
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